sv4
As filed with the Securities and Exchange Commission on
April 25, 2006
Registration
No. 333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
EPIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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2835 |
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04-3030815 |
(State or other jurisdiction of
incorporation or organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification No.) |
161 First Street
Cambridge, Massachusetts 02142
(617) 250-6000
(Address, including zip code, and telephone number,
including area code, of registrants principal executive
offices)
Michael J. Astrue
Interim Chief Executive Officer
EPIX Pharmaceuticals, Inc.
161 First Street
Cambridge, Massachusetts 02142
(617) 250-6000
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
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William T. Whelan, Esq.
Daniel T. Kajunski, Esq.
Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo P.C.
One Financial Center
Boston, Massachusetts 02111
(617) 542-6000 |
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Michael G. Kauffman, M.D., Ph.D.
Predix Pharmaceuticals Holdings, Inc.
4 Maguire Road
Lexington, Massachusetts 02421
(781) 372-3260 |
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Lawrence S. Wittenberg, Esq.
Edward A. King, Esq.
Goodwin Procter LLP
Exchange Place
Boston, Massachusetts 02109
(617) 570-1000 |
Approximate date of commencement of proposed sale to the
public: As soon as practicable after this registration
statement becomes effective and upon completion of the merger
described in the enclosed joint proxy statement/ prospectus.
If the securities being registered on this Form are to be
offered in connection with the formation of a holding company
and there is compliance with General Instruction G, check the
following
box. o
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
CALCULATION OF REGISTRATION FEE
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Proposed Maximum |
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Proposed Maximum |
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Amount of |
Title of Each Class of |
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Amount |
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Offering |
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Aggregate |
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Registration |
Securities to be Registered |
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to be Registered(1) |
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Price per Share |
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Offering Price(2) |
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Fee(2) |
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Common Stock, $.01 par value per share
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33,275,484 |
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N/A |
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$914,159 |
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$97.82 |
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(1) |
Represents the maximum number of shares of common stock, par
value $.01 per share, of the Registrant estimated to be
issuable upon the completion of the proposed merger of Predix
Pharmaceuticals Holdings, Inc. (Predix) with and
into EPIX Delaware, Inc., a wholly-owned subsidiary of the
Registrant, determined by multiplying 1.248509 by 18,642,624
(which is the estimated number of fully-diluted shares of Predix
on the date hereof). Also includes 10,000,000 shares of the
Registrants common stock that may be issuable upon the
achievement of the milestone events as described in the joint
proxy statement/ prospectus, based on the closing sale price of
the Registrants common stock on March 31, 2006, the
last full trading day immediately preceding the public
announcement of the merger. |
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(2) |
Estimated solely for purposes of calculation of the registration
fee in accordance with Rules 457(c) and (f) of the
Securities Act of 1933, as amended. Predix is a privately-held
corporation and there is no market for its securities. In
addition, Predix has an accumulated deficit. Therefore, pursuant
to Rule 457(f)(2) under the Securities Act of 1933, as
amended, the proposed maximum offering price is based upon
one-third of the aggregate par value of Predixs capital
stock being acquired in the proposed merger, which is $0.01
(computed as of April 24, 2006, the latest practicable date
prior to the date of filing this Registration Statement). |
The Registrant hereby amends this Registration Statement on
such date or dates as may be necessary to delay its effective
date (i) until the Registrant shall file a further
amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or
(ii) until the Registration Statement shall become
effective on such date as the Securities and Exchange
Commission, acting pursuant to said Section 8(a), may
determine.
The
information in this joint proxy statement/ prospectus is not
complete and may be changed. The securities being offered by the
use of this joint proxy statement/ prospectus may not be issued
until the registration statement filed with the Securities and
Exchange Commission, of which this proxy statement and
prospectus is a part, is declared effective. This joint proxy
statement/ prospectus is not an offer to sell these securities
nor a solicitation of any offer to buy these securities in any
jurisdiction where the offer or sale is not
permitted.
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PRELIMINARY
COPY
SUBJECT TO
COMPLETION, DATED APRIL 25, 2006
ANNUAL AND SPECIAL MEETINGS OF STOCKHOLDERS
MERGER PROPOSED YOUR VOTE IS VERY IMPORTANT
The boards of directors of EPIX Pharmaceuticals, Inc.
(EPIX) and Predix Pharmaceuticals Holdings, Inc.
(Predix) have approved a merger combining EPIX and
Predix.
If the merger is consummated, Predix will be merged with and
into a wholly-owned subsidiary of EPIX. The terms of the merger
agreement provide for the issuance of shares of EPIX common
stock to Predix stockholders in exchange for all of the
outstanding shares of Predix. At the effective time of the
merger, EPIX stockholders will retain approximately 53%, and the
former Predix stockholders will own approximately 47%, of the
outstanding shares of EPIXs common stock as more fully
described in the joint proxy statement/ prospectus. EPIX will
also assume all of Predixs stock options and warrants
outstanding at the time of the merger. In addition, EPIX will
make a milestone payment of $35 million to Predix
stockholders, option holders and warrant holders upon the
occurrence of certain events. EPIX may elect to make the
milestone payment in cash or in shares of EPIX common stock, to
the extent that the aggregate amount of EPIX common stock as a
result of such milestone payment does not exceed 49.99% of the
outstanding shares of EPIX common stock immediately after such
milestone payment, when combined with all shares of EPIX common
stock issued in the merger and issuable upon exercise of all
Predix options and warrants assumed by EPIX in the merger. EPIX
common stock is listed on The NASDAQ National Market under the
symbol EPIX. On April 24, 2006, the last
trading day before the date of this joint proxy statement/
prospectus, the closing sale price of EPIX common stock was
$3.92 per share. The merger is intended to qualify for federal
income tax purposes as a reorganization under the provisions of
Section 368 of the Internal Revenue Code of 1986, as
amended.
Stockholders of EPIX will be asked, at EPIXs annual
meeting of stockholders, among other proposals, to approve the
merger, to approve an amendment to EPIXs restated
certificate of incorporation and to approve the issuance of
shares of EPIX common stock to the stockholders of Predix in the
merger. Stockholders of Predix will be asked, at Predixs
special meeting of stockholders, to approve and adopt the merger
agreement and to approve the merger.
The dates, times and places of the special meetings are as
follows:
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For EPIX
stockholders: ,
2006
10:00 a.m., local time
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
One Financial Center
Boston, Massachusetts 02111 |
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For Predix
stockholders: ,
2006
9:00 a.m., local time
Goodwin Procter LLP
Exchange Place
Boston, Massachusetts 02109 |
This joint proxy statement/ prospectus provides you with
information about EPIX, Predix and the proposed merger. You may
obtain other information about EPIX and Predix from documents
filed with the Securities and Exchange Commission. We encourage
you to carefully read the entire joint proxy statement/
prospectus.
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Michael J. Astrue
Interim Chief Executive Officer
EPIX Pharmaceuticals, Inc. |
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Michael G. Kauffman, M.D., Ph.D.
Chief Executive Officer
Predix Pharmaceuticals Holdings, Inc. |
FOR A DISCUSSION OF SIGNIFICANT MATTERS THAT SHOULD BE
CONSIDERED BEFORE VOTING AT THE STOCKHOLDER MEETINGS, SEE
RISK FACTORS BEGINNING ON PAGE 19.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES REGULATORS HAVE APPROVED OR DISAPPROVED THE EPIX
COMMON STOCK TO BE ISSUED IN THE MERGER OR DETERMINED WHETHER
THIS JOINT PROXY STATEMENT/ PROSPECTUS IS ACCURATE OR ADEQUATE.
ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
This joint proxy statement/ prospectus is
dated ,
2006, and is first being mailed to stockholders of EPIX and
Predix on or
about ,
2006.
THIS JOINT PROXY STATEMENT/ PROSPECTUS IS NOT AN OFFER TO
SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY
THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT
PERMITTED.
ADDITIONAL INFORMATION
This joint proxy statement/ prospectus incorporates important
business and financial information about EPIX and Predix from
other documents that are not included in or delivered with the
joint proxy statement/ prospectus. This information is available
to you without charge upon your written or oral request. You can
obtain the documents incorporated by reference in this joint
proxy statement/ prospectus by requesting them in writing or by
telephone or over the Internet from the appropriate company at
one of the following addresses:
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EPIX Pharmaceuticals, Inc. |
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Attn: Investor Relations |
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161 First Street |
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Cambridge, Massachusetts 02142 |
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(617) 250-6000 |
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E-mail:
ahedison@epixpharma.com |
Or:
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Predix Pharmaceuticals Holdings, Inc. |
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Attn: Investor Relations |
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4 Maguire Road |
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Lexington, Massachusetts 02421 |
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(781) 372-3260 |
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E-mail:
investors@predixpharm.com |
IF YOU WOULD LIKE TO REQUEST ANY DOCUMENTS, PLEASE DO SO
BY ,
2006, THE DATE THAT IS FIVE BUSINESS DAYS BEFORE THE ANNUAL AND
SPECIAL MEETINGS, IN ORDER TO RECEIVE THEM BEFORE THE ANNUAL AND
SPECIAL MEETINGS.
See Where You Can Find More Information beginning on
page 218.
EPIX Pharmaceuticals
161 First Street
Cambridge, Massachusetts 02142
(617) 250-6000
NOTICE OF ANNUAL MEETING OF EPIX STOCKHOLDERS
TO BE HELD
ON ,
2006
To the Stockholders of EPIX Pharmaceuticals, Inc:
On behalf of the board of directors of EPIX Pharmaceuticals,
Inc, a Delaware corporation, we are pleased to deliver this
joint proxy statement/ prospectus for the proposed merger
combining EPIX and Predix Pharmaceuticals Holdings, Inc., a
Delaware corporation. An annual meeting of stockholders of EPIX
will be held
on ,
2006 at 10:00 a.m., local time, at the offices of Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial
Center, Boston, Massachusetts, 02111 for the following purposes:
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1. To consider and vote upon the issuance of shares of EPIX
common stock in the merger as contemplated by the Agreement and
Plan of Merger, dated as of April 3, 2006, by and among
EPIX Pharmaceuticals, Inc., EPIX Delaware, Inc., a wholly-owned
subsidiary of EPIX, and Predix Pharmaceuticals Holdings, Inc.,
and approve the merger of Predix Pharmaceuticals Holdings, Inc.
with and into EPIX Delaware, Inc.; |
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2. To approve an amendment to EPIXs amended and
restated certificate of incorporation to increase the number of
authorized shares of common stock from 40,000,000 shares to
100,000,000 shares, which represents an additional
60,000,000 shares, as described in the joint proxy
statement/ prospectus; |
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3. To elect two directors for a three-year term to expire
at the 2009 annual meeting of stockholders; provided, however,
that, if the merger is completed, the EPIX board of directors
will consist of the nine persons identified in the joint proxy
statement/ prospectus; |
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4. To ratify the selection of Ernst & Young LLP as
EPIXs independent registered public accounting firm for
the fiscal year ending December 31, 2006; |
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5. To consider and vote on a proposal to approve the
adjournment of the annual meeting, if necessary, to solicit
additional proxies, in the event that there are not sufficient
votes at the time of the annual meeting to approve
Proposal Nos. 1 and 2; and |
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6. To transact such other business as may properly come
before the annual meeting or any adjournment or postponement
thereof. |
The board of directors of EPIX has
fixed ,
2006 as the record date for the determination of stockholders
entitled to notice of, and to vote at, the annual meeting and
any adjournment or postponement thereof. Only holders of record
of shares of EPIX common stock at the close of business on the
record date are entitled to notice of, and to vote at, the
annual meeting. At the close of business on the record date,
EPIX
had shares
of common stock outstanding and entitled to vote.
Your vote is important. The affirmative vote of the holders
of a majority of the shares present at the EPIX annual meeting
is required for approval of Proposal Nos. 1, 4, 5 and
6 above. The affirmative vote of the holders of a majority of
the outstanding common stock on the record date is required for
approval of Proposal No. 2. The affirmative vote of a
plurality of the votes cast at the EPIX annual meeting is
required for approval of Proposal No. 3. Even if you
plan to attend the annual meeting in person, we request that you
sign and return the enclosed proxy and thus ensure that your
shares will be represented at the annual meeting if you are
unable to attend. If you sign, date and mail your proxy card
without indicating how you wish to vote, your proxy will be
counted as a vote in favor of Proposal Nos. 1 through 6. If
you fail to return your proxy card, the effect will be a vote
against the adoption of Proposal No. 2 and your shares
will not be counted for purposes of determining whether a quorum
is present at the annual meeting. If you do attend the EPIX
annual meeting and wish to vote in person, you may withdraw your
proxy and vote in person.
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By Order of the Board of Directors, |
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Michael J. Astrue |
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Interim Chief Executive Officer |
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EPIX Pharmaceuticals, Inc. |
Cambridge, Massachusetts
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2006
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
THE ISSUANCE OF SHARES OF EPIX COMMON STOCK IN THE MERGER IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, EPIX AND ITS
STOCKHOLDERS AND HAS APPROVED SUCH ISSUANCE. THE EPIX BOARD OF
DIRECTORS RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF SHARES OF EPIX
COMMON STOCK IN THE MERGER AND APPROVE THE MERGER.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
AN AMENDMENT TO EPIXS RESTATED CERTIFICATE OF
INCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK FROM 40,000,000 SHARES TO 100,000,000 SHARES, WHICH
REPRESENTS AN ADDITIONAL 60,000,000 SHARES, IS ADVISABLE TO, AND
IN THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH AMENDMENT. THE EPIX BOARD OF DIRECTORS RECOMMENDS
THAT EPIX STOCKHOLDERS VOTE FOR PROPOSAL NO. 2
TO APPROVE AN AMENDMENT TO EPIXS RESTATED CERTIFICATE OF
INCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK FROM 40,000,000 SHARES TO 100,000,000 SHARES. THE
APPROVAL OF PROPOSAL NO. 2 IS NECESSARY TO ENABLE EPIX TO
ISSUE THE REQUIRED NUMBER OF SHARES OF EPIX COMMON STOCK TO
PREDIX STOCKHOLDERS, OPTION HOLDERS AND WARRANT HOLDERS IN
CONNECTION WITH THE MERGER.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
THE ELECTION OF TWO DIRECTORS FOR A THREE-YEAR TERM TO EXPIRE AT
THE 2009 ANNUAL MEETING OF STOCKHOLDERS IS ADVISABLE TO, AND IN
THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED AND ADOPTED THE PROPOSAL. THE EPIX BOARD OF DIRECTORS
RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 3 TO ELECT TWO DIRECTORS FOR A THREE-YEAR TERM
TO EXPIRE AT THE 2009 ANNUAL MEETING OF STOCKHOLDERS; PROVIDED,
HOWEVER, THAT, IF THE MERGER IS COMPLETED, THE EPIX BOARD OF
DIRECTORS WILL CONSIST OF THE NINE PERSONS IDENTIFIED IN THE
ACCOMPANYING JOINT PROXY STATEMENT/ PROSPECTUS
THE EPIX BOARD OF DIRECTORS HAS DETERMINED THAT THE
RATIFICATION OF THE SELECTION OF ERNST & YOUNG LLP AS
EPIXS INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM FOR
THE FISCAL YEAR ENDING DECEMBER 31, 2006 IS ADVISABLE TO,
AND IN THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH RATIFICATION. THE EPIX BOARD OF DIRECTORS
RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 4 TO RATIFY THE SELECTION OF ERNST &
YOUNG LLP AS EPIXS INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM FOR THE FISCAL YEAR ENDING DECEMBER 31,
2006.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
ADJOURNING THE EPIX ANNUAL MEETING, IF NECESSARY, IF A QUORUM IS
PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT
SUFFICIENT VOTES IN FAVOR OF PROPOSAL NOS. 1 AND 2 IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, EPIX AND ITS
STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE PROPOSAL. THE EPIX
BOARD OF DIRECTORS RECOMMENDS THAT EPIX STOCKHOLDERS VOTE
FOR PROPOSAL NO. 5 TO ADJOURN THE EPIX ANNUAL
MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT
ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF
PROPOSAL NOS. 1 AND 2.
4 Maguire Road
Lexington, Massachusetts 02421
(781) 372-3260
NOTICE OF SPECIAL MEETING OF PREDIX STOCKHOLDERS
TO BE HELD
ON ,
2006
To the Stockholders of Predix Pharmaceuticals Holdings, Inc.:
On behalf of the board of directors of Predix Pharmaceuticals
Holdings, Inc., a Delaware corporation, we are pleased to
deliver this joint proxy statement/ prospectus for the proposed
merger combining EPIX Pharmaceuticals, Inc. and Predix. A
special meeting of stockholders of Predix will be held
on ,
2006 at 9:00 a.m., local time, at the offices of Goodwin Procter
LLP, Exchange Place, Boston, Massachusetts, 02109 for the
following purposes:
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1. To consider and vote on a proposal to approve and adopt
the Agreement and Plan of Merger, dated as of April 3,
2006, by and among EPIX Pharmaceuticals, Inc., EPIX Delaware,
Inc., a wholly-owned subsidiary of EPIX, and Predix
Pharmaceuticals Holdings, Inc., and approve the merger of Predix
Pharmaceuticals Holdings, Inc. with and into EPIX Delaware, Inc.; |
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2. To consider and vote on a proposal to approve the
adjournment of the special meeting, if necessary, to solicit
additional proxies, in the event that there are not sufficient
votes at the time of the special meeting to approve and adopt
the merger agreement and to approve the merger; and |
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3. To transact such other business as may properly come
before the special meeting or any adjournment or postponement
thereof. |
The board of directors of Predix has
fixed ,
2006 as the record date for the determination of stockholders
entitled to notice of, and to vote at, the special meeting and
any adjournment or postponement thereof. Only holders of record
of shares of Predix common stock and holders of record of shares
of Predix preferred stock at the close of business on the record
date are entitled to notice of, and to vote at, the special
meeting. Holders of Predix preferred stock vote on an
as-converted to Predix common stock basis. At the close of
business on the record date, Predix had outstanding and entitled
to vote (a) 1,044,059 shares of common stock and
(b) 273,203,492 shares of preferred stock, consisting
of 76,771,672 shares of Series AB preferred stock,
which are convertible into 4,265,060 shares of Predix
common stock and 196,431,820 shares of Series C
preferred stock, which are convertible into
10,912,838 shares of Predix common stock.
Your vote is important. The affirmative vote of the holders
of: (a) a majority of the common stock and the preferred
stock voting as a single class (on an as-converted to Predix
common stock basis); (b) 60% of the preferred stock voting
as a single class (on an as-converted to Predix common stock
basis), and
(c) 662/3%
of the shares of the Series C preferred stock (on an
as-converted to Predix common stock basis), in each case,
outstanding on the record date, is required for approval of
Proposal No. 1 above. The affirmative vote of the
holders of a majority of the outstanding common stock and the
preferred stock voting as a single class on an as-converted to
Predix common stock basis on the record date is required for
approval of Proposal Nos. 2 and 3 above. Even if you plan
to attend the special meeting in person, we request that you
sign and return the enclosed proxy and thus ensure that your
shares will be represented at the special meeting if you are
unable to attend. If you sign, date and mail your proxy card
without indicating how you wish to vote, your proxy will be
counted as a vote in favor of the approval and adoption of the
merger agreement and the approval of the merger and an
adjournment of the Predix special meeting, if necessary, if a
quorum is present, to solicit additional proxies if there are
not sufficient votes in favor of Proposal No. 1. If
you fail to return your proxy card,
the effect will be a vote against the approval and adoption
of the merger agreement and the approval of the merger and your
shares will not be counted for purposes of determining whether a
quorum is present at the Predix special meeting. If you do
attend the Predix special meeting and wish to vote in person,
you may withdraw your proxy and vote in person.
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By Order of the Board of Directors, |
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Michael G. Kauffman, M.D., Ph.D. |
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President and Chief Executive Officer |
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Predix Pharmaceuticals Holdings, Inc. |
Lexington, Massachusetts
,
2006
THE PREDIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE MERGER IS ADVISABLE TO, AND IN THE BEST INTERESTS OF,
PREDIX AND ITS STOCKHOLDERS AND HAS APPROVED THE MERGER AND THE
MERGER AGREEMENT. THE PREDIX BOARD OF DIRECTORS RECOMMENDS THAT
PREDIX STOCKHOLDERS VOTE FOR PROPOSAL NO. 1 TO
APPROVE AND ADOPT THE MERGER AGREEMENT AND TO APPROVE THE MERGER
AND FOR PROPOSAL NO. 2 TO ADJOURN THE SPECIAL
MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT
ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF
PROPOSAL NO. 1.
TABLE OF CONTENTS
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ii
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iii
iv
QUESTIONS AND ANSWERS ABOUT THE MERGER
The following section provides answers to frequently asked
questions about the effect of the merger on the holders of EPIX
common stock and Predix common stock, preferred stock, warrants
and stock options. EPIX and Predix urge you to read carefully
the remainder of this joint proxy statement/ prospectus,
including the documents attached to this joint proxy statement/
prospectus, because the information in this section does not
provide all the information that might be important to you
regarding the merger and the other matters being considered at
the EPIX annual meeting and the Predix special meeting.
|
|
|
Q: |
|
Why are EPIX and Predix proposing the merger? (See
pages 63 and 72) |
|
A: |
|
EPIX and Predix are proposing the merger because they believe
the resulting combined company will be a stronger, more diverse
company with more growth potential than either company would
have separately. |
|
|
|
|
|
EPIX and Predix believe that the merger may result in a number
of benefits, including: |
|
|
|
a broader, more balanced portfolio of product
candidates, with significant market potential; |
|
|
|
the opportunity for each companys stockholders
to participate in the potential growth of the combined company
after the merger; and |
|
|
|
a seasoned management team and significant financial
resources. |
|
|
|
Q: |
|
Why am I receiving this joint proxy statement/ prospectus? |
|
A: |
|
You are receiving this joint proxy statement/ prospectus because
you have been identified as a stockholder of either EPIX or
Predix, and thus you are entitled to vote at EPIXs annual
meeting or Predixs special meeting, as the case may be.
This document serves as both a joint proxy statement of EPIX and
Predix, used to solicit proxies for the stockholder meetings,
and as a prospectus of EPIX, used to offer shares of EPIX common
stock in exchange for shares of Predix common stock and
preferred stock pursuant to the terms of the merger agreement.
This document contains important information about the merger
and the stockholder meetings of EPIX and Predix, and you should
read it carefully. |
|
Q: |
|
What percentage of EPIX will EPIXs current stockholders
and the former Predix stockholders own collectively immediately
following the merger? (See page 57) |
|
A: |
|
At the effective time of the merger, the current EPIX
stockholders will collectively own approximately 53% of the
outstanding shares of the combined company and the former Predix
stockholders will collectively own approximately 47% of the
outstanding shares of the combined company, based on the number
of shares of EPIX common stock and Predix common stock and
preferred stock outstanding as of the date of the merger
agreement. |
|
Q: |
|
What will a Predix stockholder receive in exchange for Predix
stock in the merger? (See pages 57 and 80) |
|
A: |
|
Each Predix stockholder will receive 1.248509 shares of
EPIX common stock for each share of Predix common stock or
preferred stock (on an as-converted to Predix common stock
basis) that they own, and cash in lieu of fractional shares. We
refer to this as the exchange ratio. |
|
|
|
|
|
In addition, EPIX will make a milestone payment to Predix
stockholders, option holders and warrant holders in an aggregate
amount of $35 million upon the occurrence of certain
events. EPIX may elect to make the milestone payment in cash or
shares of EPIX common stock, or any combination thereof. The
milestone payment will be allocated and paid to each holder of
Predix shares, options and warrants at the time of the merger,
on a pro rata basis assuming that each Predix warrant and option
(whether or not vested) was exercised in full immediately prior
to the merger. |
|
|
|
In no event will the shares of EPIX common stock issuable at the
effective time of the merger, including the shares of EPIX
common stock issuable upon exercise of Predix options and
warrants assumed by EPIX in the merger, exceed 49.99% of the
outstanding EPIX common stock immediately |
v
|
|
|
after the effective time of the merger. In addition, in no event
may the milestone be paid in shares of EPIX common stock to the
extent that such shares would exceed 49.99% of the outstanding
shares of EPIX common stock immediately after such milestone
payment, when combined with all shares of EPIX common stock
issued in the merger and issuable upon exercise of all Predix
options and warrants assumed by EPIX in the merger. |
|
|
|
Q: |
|
What events will trigger the milestone payment from EPIX?
(See pages 57 and 80) |
|
A: |
|
Predix stockholders, option holders and warrant holders will
receive the milestone payment within 90 days following the
occurrence, as determined by the non-Predix members of the
combined companys board of directors, of any of the
following events on or before June 30, 2008: |
|
|
|
|
|
receipt of statistically significant final results
from a randomized, placebo- or active comparator controlled,
double-blinded Phase II or Phase III clinical trial of: |
|
|
|
PRX-00023 for the
treatment of generalized anxiety disorder, or GAD, depression,
attention-deficit hyperactivity disorder, or ADHD, or other
neuropsychiatric disorder with at least 100 patients; |
|
|
|
PRX-03140 for the
treatment of Alzheimers disease or other cognitive
disorders with at least 60 patients; |
|
|
|
PRX-08066 for the
treatment of pulmonary artery hypertension, or PAH, chronic
obstructive pulmonary disease, or COPD, or a different
indication with at least 60 patients; |
|
|
|
PRX-07034 for the
treatment of obesity, cognitive disorders or a different
indication with at least 60 patients; or |
|
|
|
entering into a strategic partnership for any Predix
drug candidate, which provides milestone and research funding
payments of more than $50 million, of which
$20 million must be in unrestricted cash received by
June 30, 2008 through non-refundable license fees, research
funding payments, and/or premiums paid in connection with an
equity investment by the strategic partner within 60 days
following entry into the strategic partnership. |
|
|
|
Q: |
|
If triggered, when will the milestone payment be made? (See
pages 57 and 80) |
|
A: |
|
The milestone payment will be paid within 90 days after the
achievement of a milestone event, at the option of the
non-Predix members of the combined companys board of
directors, either: |
|
|
|
|
|
in cash, shares of EPIX common stock or any
combination thereof with such shares being valued based on the
five-day average closing price of EPIX common stock on The
NASDAQ National Market ending on the trading day that is ten
days prior to the milestone payment; or |
|
|
|
$20 million payable in accordance with the
preceding bullet and $15 million payable on the date that
is 12 months after the payment of the initial
$20 million in shares of EPIX common stock, with such
shares being valued based on 75% of the
30-day average closing
price of EPIX common stock on The NASDAQ National Market ending
on the trading day that is ten days prior to the payment date.
If, as a result of the 49.99% limitation described below, the
entire $15 million payment cannot be made in shares of EPIX
common stock, the balance will be paid in cash plus interest
calculated from the milestone payment date at the rate of
10% per year. |
|
|
|
In no event may the milestone be paid in shares of EPIX common
stock to the extent that such shares would exceed 49.99% of the
outstanding shares of EPIX common stock immediately after such
milestone payment, when combined with all shares of EPIX common
stock issued in the merger and issuable upon exercise of all
Predix options and warrants assumed by EPIX in the merger.
Additionally, the milestone will be paid in cash to the holders
of Predix options and warrants assumed by EPIX in the merger. |
vi
|
|
|
Q: |
|
Who will be the directors of EPIX following the merger? (See
page 93) |
|
A: |
|
Following the merger, the board of directors of EPIX will
consist of nine members, of which five will be designated by
EPIX and four will be designated by Predix. The following
individuals are expected to comprise the EPIX board of directors
after the merger: |
|
|
|
|
|
Christopher F.O. Gabrieli, Chairman
Patrick J. Fortune, Ph.D.
Frederick Frank
Michael Gilman, Ph.D.
Michael G. Kauffman, M.D., Ph.D.
Mark Leuchtenberger
Gregory D. Phelps
Ian F. Smith, CPA, ACA |
|
|
|
In addition, the board of directors of EPIX after the merger
will have an additional member designated by EPIX who has not
yet been identified. |
|
|
|
Q: |
|
Who will manage EPIX following the merger? (See
page 93) |
|
A: |
|
Following the merger, the management team and key employees of
EPIX will be comprised of certain key employees and members of
both EPIXs and Predixs respective management teams
prior to the merger and is expected to include the following
individuals: |
|
|
|
|
|
Name |
|
Position in the Combined Company |
|
Current Position |
|
|
|
|
|
Michael G. Kauffman, M.D., Ph.D.
|
|
Chief Executive Officer and Director (principal executive
officer) |
|
Predixs President and Chief Executive Officer |
Andrew C.G. Uprichard, M.D.
|
|
President |
|
EPIXs President and Chief Operating Officer |
Kimberlee C. Drapkin, CPA
|
|
Chief Financial Officer (principal financial officer) |
|
Predixs Chief Financial Officer |
Oren Becker, Ph.D.
|
|
Chief Scientific Officer |
|
Predixs Chief Scientific Officer |
Stephen R. Donahue M.D.
|
|
Vice President of Clinical & Regulatory Affairs |
|
Predixs Vice President of Clinical and Regulatory Affairs |
Philip Graham, Ph.D.
|
|
Vice President of Product Management and Imaging |
|
EPIXs Vice President of Program Management |
Thomas McMurry, Ph.D.
|
|
Vice President of Imaging Research |
|
EPIXs Vice President of Research |
Silvia Noiman, Ph.D.
|
|
Senior Vice President of Pipeline Management, General Manager
Israel |
|
Predixs Senior Vice President of Pipeline Management,
General Manager Israel |
Robert Pelletier, CPA
|
|
Executive Director of Finance (principal accounting
officer) |
|
EPIXs Executive Director of Finance |
Chen Schor, CPA
|
|
Chief Business Officer |
|
Predixs Chief Business Officer |
Sharon Shacham, Ph.D.
|
|
Vice President of Preclinical Development and Product Leadership |
|
Predixs Vice President of Preclinical Development and
Product Leadership |
Brenda Sousa
|
|
Vice President of Human Resources |
|
EPIXs Vice President of Human Resources |
|
|
|
Q: |
|
What stockholder approval is needed to complete the merger?
(See pages 52 and 55) |
|
A: |
|
To consummate the merger, EPIX stockholders must approve
(a) the issuance of shares of EPIX common stock in the
merger and approve the merger, which requires the affirmative
vote of the holders of a majority of the shares present at the
EPIX annual meeting, whether in person or by proxy, and
(b) the amendment to EPIXs restated certificate of
incorporation increasing the number of |
vii
|
|
|
|
|
authorized shares of EPIX common stock, which requires the
affirmative vote of the holders of a majority of the outstanding
shares of EPIX common stock as of the record date. In addition,
Predix stockholders must vote to approve and adopt the merger
agreement and to approve the merger, which requires the
affirmative vote of the holders of: (a) a majority of the
Predix common stock and preferred stock voting as a single class
(on an as-converted to Predix common stock basis); (b) 60%
of the Predix preferred stock voting as a single class (on an
as-converted to Predix common stock basis), and
(c) 662/3
% of the shares of Predix Series C preferred stock
(on an as-converted to Predix common stock basis), in each case,
outstanding on the record date for the Predix special meeting. |
|
|
|
|
|
In addition to obtaining stockholder approval and appropriate
regulatory approvals, including antitrust clearance, each of the
other closing conditions set forth in the merger agreement must
be satisfied or waived. For a more complete description of the
closing conditions under the merger agreement, we urge you to
read the section entitled The Merger Agreement
Conditions to the Completion of the Merger on page 89
of this joint proxy statement/ prospectus. |
|
|
|
Q: |
|
What do I need to do now? (See pages 50 and 54) |
|
A: |
|
After carefully reading and considering the information
contained in and incorporated into this joint proxy statement/
prospectus, please submit your proxy card according to the
instructions on the enclosed proxy card as soon as possible. If
you do not submit a proxy card or attend the special meeting and
vote in person, your shares will not be represented or voted at
the meeting. |
|
Q: |
|
Will the merger trigger the recognition of gain or loss for
U.S. federal income tax purposes for Predix stockholders?
(See page 74) |
|
A: |
|
The closing of the merger is conditioned upon the receipt by
Predix and EPIX of opinions that the merger will constitute a
reorganization for U.S. federal income tax purposes.
Assuming the merger does constitute a reorganization, subject to
the limitations and qualifications described in The
Merger Material United States Federal Income Tax
Consequences of the Merger, each Predix stockholder
generally will recognize gain, but not loss, for federal income
tax purposes in an amount equal to the lesser of (a) the
amount of cash such Predix stockholder receives in the merger or
(b) the amount, if any, by which the sum of (i) the
fair market value, as of the effective time of the merger, of
any EPIX common stock such Predix stockholder receives, and
(ii) the amount of cash such Predix stockholder receives in
the merger, exceeds such Predix stockholders adjusted tax
basis in its shares of Predix common stock or preferred stock,
as applicable. Any cash received in lieu of a fractional share
of EPIX common stock will be treated separately for federal
income tax purposes. The tax consequences to Predix stockholders
will depend on each stockholders own circumstances. Each
Predix stockholder should consult with his, her or its tax
advisor for a full understanding of the tax consequences of the
merger to that stockholder. |
|
Q: |
|
How does the EPIX Board of Directors recommend that I
vote? |
|
A: |
|
After careful consideration, the EPIX board of directors
recommends that EPIX stockholders vote: |
|
|
|
|
|
FOR Proposal No. 1 to approve
the issuance of shares of EPIX common stock in the merger and
approve the merger; |
|
|
|
FOR Proposal No. 2 to approve
an amendment to EPIXs amended and restated certificate of
incorporation to increase the number of authorized shares of
common stock from 40,000,000 shares to
100,000,000 shares; |
|
|
|
FOR Proposal No. 3 to elect
two directors for a three-year term to expire at the 2009 annual
meeting of stockholders; provided, however, that if the merger
is completed, the EPIX board of directors will consist of the
nine persons identified in this joint proxy statement/
prospectus; |
|
|
|
FOR Proposal No. 4 to ratify
the selection of Ernst & Young LLP as EPIXs
independent registered public accounting firm for the fiscal
year ending December 31, 2006; and |
|
|
|
FOR Proposal No. 5 to adjourn
the annual meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal Nos. 1 and 2. |
viii
|
|
|
Q: |
|
How does the Predix Board of Directors recommend that I
vote? |
|
A: |
|
After careful consideration, the Predix board of directors
recommends that Predix stockholders vote: |
|
|
|
|
|
FOR Proposal No. 1 to approve
and adopt the merger agreement and to approve the
merger; and |
|
|
|
FOR Proposal No. 2 to adjourn
the special meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal No. 1. |
|
|
|
Q: |
|
What risks should I consider in deciding whether to vote in
favor of the share issuance, approval of the merger and the
amendment to EPIXs restated certificate of incorporation
or the approval and adoption of the merger agreement? |
|
A: |
|
You should carefully review the section of this joint proxy
statement/ prospectus entitled Risk Factors
beginning on page 19, which sets forth certain risks and
uncertainties related to the merger and risks and uncertainties
to which the combined companys business will be subject,
including the individual businesses of each of EPIX and Predix. |
|
Q: |
|
What happens if I do not return a proxy card or otherwise
provide proxy instructions? |
|
A: |
|
If you are an EPIX stockholder, the failure to return your proxy
card or otherwise provide proxy instructions could be a factor
in establishing a quorum for the annual meeting of EPIX
stockholders. In addition, the failure to return your proxy card
or otherwise provide instructions will have the same effect as
voting against Proposal No. 2, the amendment of
EPIXs restated certificate of incorporation to increase
the authorized shares of EPIX common stock, the approval of
which is necessary to enable EPIX to issue shares of EPIX common
stock to Predix stockholders, option holders and warrant holders
in connection with the merger. If you are a Predix stockholder,
the failure to return your proxy card or otherwise provide proxy
instructions will have the same effect as voting against the
approval and adoption of the merger agreement and the approval
of the merger, and could be a factor in establishing a quorum
for the special meeting of Predix stockholders. |
|
Q: |
|
May I vote in person? |
|
A: |
|
If your shares of EPIX common stock on the record date are
registered directly in your name with EPIXs transfer agent
you are considered, with respect to those shares, the
stockholder of record, and the proxy materials and proxy card
are being sent directly to you by EPIX. If you are an EPIX
stockholder of record, you may attend the annual meeting of EPIX
stockholders to be held
on ,
2006 and vote your shares in person, rather than signing and
returning your proxy card or otherwise providing proxy
instructions. Each Predix stockholder on the record date is a
stockholder of record and may attend the special meeting of
Predix stockholders to be held
on ,
2006 and vote your shares in person, rather than signing and
returning your proxy card or otherwise providing proxy
instructions. All EPIX and Predix stockholders are requested to
return their proxy cards, even if they intend to vote in person. |
|
Q: |
|
May I change my vote after I have provided proxy
instructions? |
|
A: |
|
Yes. You may change your vote at any time before your proxy is
voted at either the annual meeting of EPIX stockholders or the
special meeting of Predix stockholders. You can do this in one
of three ways. First, you can send a written notice stating that
you would like to revoke your proxy. Second, you can submit new
proxy instructions either on a new proxy card and if you are an
EPIX stockholder also, by telephone or via the Internet. Third,
you can attend the meeting and vote in person. Your attendance
alone will not revoke your proxy. If you have instructed a
broker to vote your shares of EPIX common stock, you must follow
directions received from your broker to change those
instructions. |
|
Q: |
|
Am I entitled to appraisal rights? |
|
A: |
|
Under Delaware law, Predix stockholders are entitled to
appraisal rights in connection with the merger. Please see the
section entitled The Merger Appraisal
Rights on page 78 for more information. As
EPIXs common stock is quoted on The NASDAQ National
Market, EPIX stockholders will not be entitled to appraisal
rights. |
ix
|
|
|
Q: |
|
Have any Predix stockholders entered into
lock-up agreements? |
|
A: |
|
EPIX expects to obtain
lock-up agreements from
the officers, directors and certain stockholders of Predix
covering an aggregate of approximately 8,772,286 Predix shares
(on an as-converted to Predix common stock basis), or
approximately 53% of Predixs outstanding shares, which
agreements prohibit the sale, transfer, pledge or other
disposition with respect to EPIX common stock for up to
180 days following the consummation of the merger as
follows: (a) one-third (1/3) of such holders
restricted shares will be released from the
lock-up after the
90th day
following the consummation of the merger; (b) an additional
one-third (1/3) of such holders restricted shares will be
released from the
lock-up after the
120th day
following the consummation of the merger; and (c) the
remaining one-third (1/3) of such holders restricted
shares will be released from the
lock-up after the
180th day
following the consummation of the merger. |
|
|
|
|
|
In addition, prior to the closing, EPIX expects to obtain
affiliate agreements from the holders of approximately 9,049,530
Predix shares (on an as-converted to Predix common stock basis),
representing approximately 56% of Predix outstanding shares (on
an as-converted to Predix common stock basis) as of such date.
These agreements prohibit the sale, transfer or other
disposition with respect to EPIXs common stock in
violation of the Securities Act of 1933, as amended, or the
rules and regulations thereunder. |
|
|
|
Q: |
|
Have any EPIX stockholders entered into
lock-up agreements? |
|
A: |
|
Yes. The chairman of the board of directors of EPIX, Christopher
F.O. Gabrieli, has agreed to enter into the same
lock-up agreement as
certain Predix stockholders with respect to his shares of EPIX
common stock. |
|
Q: |
|
Will Predix stockholders be able to trade the EPIX common
stock that they receive in the merger? (See page 78) |
|
A: |
|
EPIX and Predix anticipate that the EPIX common stock to be
received by stockholders of Predix in the merger will be listed
for trading on The NASDAQ National Market under the symbol
EPIX. Subject to the
lock-up agreements
discussed herein, all shares of EPIX common stock issued to
Predix stockholders, other than Predix stockholders who are
deemed to be affiliates of Predix, will be freely tradable
following the merger. EPIX has agreed to file a registration
statement with respect to these shares of EPIX common stock to
be issued in the merger to persons who are deemed to be
affiliates of Predix. As a result, these shares will also be
freely tradable upon the effectiveness of this registration
statement, subject only to certain prospectus delivery
requirements and the terms of the
lock-up agreements
described herein, if applicable. |
|
Q: |
|
Who is paying for this proxy solicitation? |
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A: |
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EPIX and Predix are conducting this proxy solicitation and will
bear the cost of soliciting proxies, including the preparation,
assembly, printing and mailing of this joint proxy statement/
prospectus, the proxy card and any additional information
furnished to stockholders of EPIX and Predix. EPIX may also
reimburse brokerage houses and other custodians, nominees and
fiduciaries for their costs of forwarding proxy and solicitation
materials to beneficial owners. |
|
Q: |
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When do you expect the merger to be completed? |
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A: |
|
EPIX and Predix are working to complete the merger as quickly as
possible. EPIX and Predix expect to complete the merger by the
end of July 2006. |
|
Q: |
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Should Predix stockholders send in their stock certificates
now? (See page 82) |
|
A: |
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No. After the merger is completed, EPIX will send you
written instructions for exchanging your Predix stock
certificates for EPIX stock certificates. |
x
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Q: |
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Whom should I call with questions? (See page 218) |
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A: |
|
If you are an EPIX stockholder and would like additional copies,
without charge, of this joint proxy statement/ prospectus or if
you have questions about the merger, including the procedures
for voting your shares, you should contact: |
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|
|
|
EPIX Pharmaceuticals, Inc.
Attn: Investor Relations
161 First Street
Cambridge, Massachusetts 02142
(617) 250-6000
E-mail:
ahedison@epixpharma.com |
|
|
|
If you are a Predix stockholder and would like additional
copies, without charge, of this joint proxy statement/
prospectus or if you have questions about the merger, including
the procedures for voting your shares, you should contact: |
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|
|
Predix Pharmaceuticals Holdings, Inc.
Attn: Investor Relations
4 Maguire Road
Lexington, Massachusetts 02421
(781) 372-3260
E-mail:
investors@predixpharm.com |
xi
SUMMARY OF THE JOINT PROXY STATEMENT/ PROSPECTUS
This summary highlights selected information from this joint
proxy statement/ prospectus and may not contain all of the
information that is important to you.
You should carefully read this entire document and the other
documents EPIX and Predix refer to for a more complete
understanding of the merger. This summary and the balance of
this document contain forward-looking statements about events
that are not certain to occur, and you should not place undue
reliance on those statements. Please carefully read
Cautionary Information Regarding Forward-Looking
Statements on page 18 of this document.
This joint proxy statement/ prospectus contains trademarks,
trade names, service marks and service names of EPIX, Predix and
other companies.
The Companies (See pages 126 and 152)
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EPIX Pharmaceuticals, Inc. |
EPIX is a pharmaceutical company focused on the discovery and
development of innovative specialty pharmaceuticals for imaging
that are designed to transform the diagnosis, treatment and
monitoring of disease. Using its proprietary Target
Visualization Technology, EPIX creates imaging agents targeted
at the molecular level. These agents are designed to enable
physicians to use Magnetic Resonance Imaging, or MRI, to obtain
detailed information about specific disease processes. MRI has
been established as the imaging technology of choice for a broad
range of applications, including the identification and
diagnosis of a variety of medical disorders. MRI is safe,
relatively cost-effective and provides three-dimensional images
that enable physicians to diagnose and manage disease in a
minimally invasive manner.
EPIXs principal executive offices are located at 161 First
Street, Cambridge, Massachusetts 02142, and its telephone number
is (617) 250-6000. EPIXs website address is
http://www.epixpharma.com. EPIXs website is a factual
reference and it is not intended to be an active link to the
website, and the information contained in the website is not a
part of this joint proxy statement/ prospectus.
EPIX Delaware, Inc. is a wholly-owned subsidiary of EPIX that
was recently incorporated in Delaware solely for the purpose of
the merger. It does not conduct any business and has no material
assets. Its principal executive offices have the same address
and telephone number as EPIX set forth above.
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Predix Pharmaceuticals Holdings, Inc. |
Predix is a privately-held pharmaceutical company focused on the
discovery and development of novel, highly selective,
small-molecule drugs that target G-Protein Coupled Receptors, or
GPCRs, and ion channels. Predix has progressed three drug
candidates into clinical trials and has six additional programs
in pre-clinical development or discovery. Predix is expecting to
complete the first of at least two pivotal Phase III
clinical trials for generalized anxiety disorder, or GAD, for
its lead drug candidate, PRX-00023, and receive initial data for
this trial in the second half of 2006. Predix completed a
Phase IIa clinical trial of PRX-00023 in this indication in
July 2005. Predix has two other clinical-stage drug candidates
that have completed Phase I clinical trials: PRX-03140 for
the treatment of Alzheimers disease that is expected to
enter Phase II clinical trials in the second half of 2006,
and PRX-08066 for the treatment of two types of pulmonary
hypertension, or PH, which are PH associated with chronic
obstructive pulmonary disease that is expected to enter
Phase II clinical trials in the second half of 2006, and
pulmonary arterial hypertension.
Predixs principal executive offices are located at 4
Maguire Road, Lexington, Massachusetts 02421, and its telephone
number is (781) 372-3260. Predixs website address is
http://www.predixpharm.com.
1
Predixs website is a factual reference and it is not
intended to be an active link to the website, and the
information contained in the website is not a part of this joint
proxy statement/ prospectus.
At the effective time of the merger, EPIX stockholders will
retain approximately 53% of the outstanding stock of the
combined company, and the former Predix stockholders will own
approximately 47% of the outstanding stock of the combined
company, based on the number of shares of EPIX common stock and
Predix common stock and preferred stock outstanding as of the
date of the merger agreement. EPIX will also assume all
outstanding Predix options and warrants in the merger. In
addition, EPIX will make a milestone payment of $35 million to
Predix stockholders, option holders and warrant holders upon the
occurrence of certain events. In no event will the shares of
EPIX common stock issuable at the effective time of the merger,
including the shares of EPIX common stock issuable upon exercise
of Predix options and warrants assumed by EPIX in the merger,
exceed 49.99% of the outstanding EPIX common stock immediately
after the effective time of the merger. In addition, in no event
may the milestone be paid in shares of EPIX common stock to the
extent that such shares would exceed 49.99% of the outstanding
shares of EPIX common stock immediately after such milestone
payment, when combined with all shares of EPIX common stock
issued in the merger and issuable upon exercise of all Predix
options and warrants assumed by EPIX in the merger. The combined
companys board of directors is expected to consist of five
directors designated by EPIX and four Predix directors
designated by Predix. In addition, the management team of the
combined company will consist of certain current members of both
EPIX and Predix. Predixs principal executive office is
expected to be the combined companys executive principal
office.
Risks Associated with the Merger and the Combined Company,
EPIX and Predix (See page 19)
The merger poses a number of risks to each company and its
respective stockholders. In addition, both EPIX and
Predixs businesses and industries are subject to various
risks. These risks are discussed in detail under the caption
Risk Factors beginning on page 19. You are
encouraged to read and consider all of these risks carefully.
Stockholder Meetings
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|
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The EPIX Annual Meeting (See page 50) |
Time, Date and Place. The annual meeting of the
stockholders of EPIX will be held
on ,
2006, at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., One Financial Center, Boston, Massachusetts,
at 10:00 a.m., local time, to vote on Proposal No. 1
to approve the issuance of shares of EPIX common stock in the
merger and approve the merger, Proposal No. 2 to
approve an amendment to EPIXs restated certificate of
incorporation to increase the number of authorized shares of
common stock from 40,000,000 shares to
100,000,000 shares, Proposal No. 3 to elect two
directors for a three-year term to expire at the 2009 annual
meeting of stockholders; provided, however, that, if the merger
is completed, the EPIX board of directors will consist of the
nine persons identified in this joint proxy statement/
prospectus, Proposal No. 4 to ratify the selection of
Ernst & Young LLP as EPIXs independent registered
public accounting firm for the fiscal year ending
December 31, 2006, and Proposal No. 5 to adjourn
the annual meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal Nos. 1 and 2.
Record Date and Voting Power for EPIX. You are entitled
to vote at the EPIX annual meeting if you owned shares of EPIX
common stock at the close of business
on ,
2006, the record date for the EPIX annual meeting. You will have
one vote at the annual meeting for each share of EPIX common
stock you owned at the close of business on the record date.
There
are shares
of EPIX common stock entitled to vote at the annual meeting.
EPIX Required Vote. The affirmative vote of the holders
of a majority of the shares present at the EPIX annual meeting,
whether in person or by proxy, is required for approval of
Proposal Nos. 1, 4, 5 and
2
6 above. The affirmative vote of the holders of a majority of
the outstanding shares of EPIX common stock on the record date
is required for approval of Proposal No. 2. The
affirmative vote of a plurality of the votes cast in person or
by proxy at the EPIX annual meeting is required for approval of
Proposal No. 3.
Share Ownership of Management. As
of ,
2006, the directors and executive officers of EPIX, together
with their affiliates, beneficially owned
approximately %
of the shares entitled to vote at the EPIX annual meeting.
|
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The Predix Special Meeting (See page 54) |
Time, Date and Place. The special meeting of the
stockholders of Predix will be held
on ,
2006, at the offices of Goodwin, Procter LLP, Exchange Place,
Boston, Massachusetts, at 9:00 a.m., local time, to vote on
Proposal No. 1 to approve and adopt the merger
agreement and approve of the merger and Proposal No. 2
to adjourn the Predix special meeting, if necessary, if a quorum
is present, to solicit additional proxies if there are not
sufficient votes in favor of Proposal No. 1.
Record Date and Voting Power for Predix. You are entitled
to vote at the Predix special meeting if you owned shares of
Predix common stock or preferred stock at the close of business
on ,
2006, the record date for the special meeting. You will have one
vote at the special meeting for each share of Predix common
stock you owned at the close of business on the record date. You
will also have one vote at the special meeting for each share of
Predix common stock issuable upon conversion of the shares of
Predix preferred stock you owned at the close of business on the
record date. There are 1,044,059 shares of Predix common
stock and 15,177,898 shares of Predix preferred stock (on
an as-converted to Predix common stock basis) entitled to vote
at the Predix special meeting.
Predix Required Vote. The affirmative vote of the holders
of (a) a majority of the Predix common stock and preferred
stock voting as a single class (on an as-converted to Predix
common stock basis), (b) 60% of the Predix preferred stock
voting as a single class (on an as-converted to Predix common
stock basis) and
(c) 662/3
% of the shares of Predix series C preferred stock
(on as as-converted to Predix common stock basis), in each case,
outstanding on the record date, is required for approval of
Proposal No. 1. The affirmative vote of the holders of
a majority of the Predix common shares and preferred shares
voting as a single class is required for approval of
Proposal No. 2.
Share Ownership of Management. As of March 31, 2006,
the directors and executive officers of Predix, together with
their affiliates, beneficially owned approximately 56% of the
shares of Predix common stock and preferred stock, on an
as-converted Predix common stock basis, entitled to vote at the
Predix special meeting. Stockholders of Predix beneficially
owning approximately 40% of the outstanding voting stock of
Predix have agreed to vote their shares in favor of the approval
and adoption of the merger agreement and the approval of the
merger. Certain of these stockholders are affiliated with
directors of Predix.
Recommendation to Stockholders
To EPIX Stockholders (See page 66). The EPIX board
of directors has determined and believes that the issuance of
shares of EPIX common stock in the merger and the merger are
advisable to and in the best interest of EPIX and its
stockholders. The EPIX board of directors recommends that the
holders of EPIX common stock vote:
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FOR Proposal No. 1 to approve the issuance
of shares of EPIX common stock in the merger and approve the
merger; |
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FOR Proposal No. 2 to approve an amendment
to EPIXs restated certificate of incorporation to increase
the number of authorized shares of common stock from
40,000,000 shares to 100,000,000 shares; |
3
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|
FOR Proposal No. 3 to elect two directors
for a three-year term to expire at the 2009 annual meeting of
stockholders; provided, however, that if the merger is
completed, the EPIX board of directors will consist of the nine
persons identified in this joint proxy statement/ prospectus; |
|
|
|
FOR Proposal No. 4 to ratify the selection
of Ernst & Young LLP as EPIXs independent
registered public accounting firm for the fiscal year ending
December 31, 2006; and |
|
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FOR Proposal No. 5 to adjourn the annual
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
Proposal Nos. 1 and 2. |
To Predix Stockholders (See page 74). The Predix
board of directors has determined and believes that the merger
is advisable to, and in the best interest of, Predix and its
stockholders. The Predix board of directors recommends that the
Predix stockholders vote:
|
|
|
|
|
FOR Proposal No. 1 to approve and adopt
the merger agreement and approve of the merger; and |
|
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|
FOR Proposal No. 2 to adjourn the Predix
special meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal No. 1. |
Fairness Opinion Received by EPIX (See page 66)
Needham & Company, LLC delivered its opinion to the
EPIX board of directors that, as of March 30, 2006, and
based on and subject to the factors and assumptions set forth
therein, the consideration to be paid by EPIX in the merger is
fair to EPIX and the holders of EPIX common stock from a
financial point of view.
The full text of the written opinion of Needham &
Company, LLC, dated March 30, 2006, which sets forth the
assumptions made, procedures followed, matters considered and
limitations on the review undertaken in connection with the
opinion, is attached to this joint proxy statement/ prospectus
as Annex C. Needham & Company, LLC provided its
opinion for the information and assistance of the EPIX board of
directors in connection with its consideration of the merger.
The written opinion of Needham & Company, LLC is not a
recommendation as to how any holder of EPIX common stock should
vote with respect to the issuance of shares of EPIX common stock
in the merger, the approval of the merger or the amendment to
EPIXs restated certificate of incorporation. EPIX urges
you to read the entire opinion of Needham & Company,
LLC carefully.
Voting Agreements (See page 92)
The following stockholders of Predix entered into voting
agreements with EPIX on April 3, 2006: Caduceus Private
Investment, L.P., UBS PW Juniper Crossover Fund, L.L.C., Hare
and Company FAO: Finsbury Worldwide Pharma, Yozma II
(Israel) L.P., Yozma Venture Capital Ltd, YVC-Yozma
Management & Investments Ltd., as trustee for
Yozma II (B.V.I.) L.P., PCM Venture Capital L.P.,
Yamanouchi Venture Capital and PA International Limited. These
entities represent an aggregate of approximately 40% of the
outstanding voting shares of Predix (on an as-converted to
Predix common stock basis). Each has agreed in the voting
agreements to vote all shares of Predix common stock and
preferred stock beneficially owned by each as of the record date
in favor of the approval and adoption of the merger agreement
and the approval of the merger. Each also granted EPIX an
irrevocable proxy to vote their shares of Predix common stock
and preferred stock in favor of the adoption of the merger
agreement and the approval of the merger. Certain of these
stockholders are affiliated with directors of Predix.
Interests of EPIXs Directors and Management (See
page 78)
Some directors and management of EPIX have interests in the
merger that are different from, and in addition to, the
interests of EPIX stockholders generally.
Upon completion of the merger, Christopher F.O. Gabrieli,
Michael Gilman, Ph.D., Mark Leuchtenberger and Gregory D.
Phelps, each of whom is a current director of EPIX, is expected
to be a member of the EPIX board of directors. In addition,
certain executive officers and key employees of EPIX
4
are expected to serve as executive officers or key employees of
EPIX after the effective time of the merger and certain officers
of EPIX will be entitled to bonuses upon completion of the
merger and/or severance payments after completion of the merger.
Upon completion of the merger and the issuance of EPIX common
stock in the merger, the directors and officers of EPIX will
collectively beneficially own approximately 1.3% of the
outstanding stock of EPIX, calculated on the basis set forth
under EPIX Principal Stockholders.
Interests of Predixs Directors and Management (See
page 79)
Some directors and management of Predix have interests in the
merger that are different from, and in addition to, the
interests of Predix stockholders generally.
Upon completion of the merger, Patrick J. Fortune, Ph.D,
Frederick Frank, Michael G. Kauffman, M.D., Ph.D. and Ian
F. Smith, CPA, ACA, each of whom is a current director of
Predix, is expected to be a member of the EPIX board of
directors. In addition, certain executive officers and key
employees of Predix are expected to serve as executive officers
or key employees of EPIX at the effective time of the merger.
Moreover, Mr. Frank, the Chairman of Predixs board of
directors, is also the Vice Chairman and a director of Lehman
Brothers Inc., Predixs financial advisor in connection
with the merger. Lehman Brothers is entitled to certain fees and
expenses from Predix upon consummation of the merger.
Certain of the stockholders of Predix who have entered into
voting agreements with EPIX, agreeing to vote all of the shares
beneficially owned by them in favor of approval and adoption of
the merger agreement and approval of the merger, are affiliated
with directors of Predix.
Pursuant to the merger agreement, upon completion of the merger,
the combined company will honor Predixs existing
obligations to indemnify its present and former directors,
officers and employees to the same extent as provided in
Predixs certificate of incorporation, by-laws or any
applicable contract or agreement. The certificate of
incorporation and by-laws of the combined company will provide
for the indemnification and limitation of liability to the same
extent as set forth in Predixs certificate of
incorporation and by-laws and the combined corporation will
indemnify and hold harmless each present and former director,
officer or employee of Predix in respect of acts or omissions
occurring prior to the completion of the merger, including in
connection with the merger agreement and the transactions
contemplated thereby.
Upon completion of the merger and the issuance of EPIX common
stock in the merger, the directors and officers of Predix, will
collectively beneficially own approximately 6.5% of the
outstanding stock of EPIX, calculated on the basis set forth
under Predix Principal Stockholders.
Completion and Effectiveness of the Merger (See pages 80 and
88)
EPIX and Predix expect to complete the merger when all of the
conditions to completion of the merger contained in the merger
agreement have been satisfied or waived. The merger will become
effective upon the filing of a certificate of merger with the
Secretary of State of the State of Delaware.
EPIX and Predix are working toward satisfying the conditions to
the merger, and expect to complete the merger promptly following
the stockholder meetings.
Restrictions on Solicitation of Alternative Transactions by
EPIX and Predix (See page 84)
EPIX and Predix have each agreed, and have further agreed to
ensure that their representatives do not, prior to the
consummation of the merger, directly or indirectly, solicit,
encourage, have negotiations with respect to (including
furnishing information) or take any action that could reasonably
be expected to result in the initiation or submission of any
inquiries, proposals or offers regarding, or approve, endorse or
recommend, any acquisition, merger, take-over bid, sale of
substantial assets, sale of shares of capital stock (including
without limitation by way of a tender offer) or similar
transactions. EPIX and Predix have also
5
agreed to notify each other upon receipt of any alternative
acquisition proposal or any inquiry that would reasonably be
expected to lead to an alternative acquisition proposal,
including the terms of the alternative acquisition proposal or
inquiry and the identity of the person making the alternative
acquisition proposal or inquiry. However, if EPIX or Predix
receives an unsolicited bona fide written acquisition proposal
that is a superior acquisition proposal prior to the EPIX annual
meeting or Predix special meeting, respectively, then EPIX or
Predix may provide nonpublic information to, and engage in
discussions and negotiations with, the third party making the
acquisition proposal so long as certain conditions are satisfied.
Conditions to the Completion of the Merger (See
page 88)
EPIX and Predixs obligations to complete the merger are
subject to certain conditions described under the heading
The Merger Agreement Conditions to the
Completion of the Merger beginning on page 88.
Termination of the Merger Agreement and Payment of Certain
Termination Fees (See pages 90 and 91)
EPIX and Predix may terminate the merger agreement by mutual
agreement and under certain other circumstances. EPIX and Predix
have agreed that if the merger agreement is terminated under the
circumstances described under The Merger
Agreement Fees and Expenses on page 91, a
termination fee of $4.5 million may be payable by either
EPIX or Predix to the other party upon the termination of the
merger agreement.
United States Federal Tax Consequences of the Merger (See
page 74)
The closing of the merger is conditioned upon the receipt by
EPIX and Predix of opinions that the merger will constitute a
reorganization for U.S. federal income tax purposes.
Assuming the merger does constitute a reorganization, subject to
the limitations and qualifications described in The
Merger Material United States Federal Income Tax
Consequences of the Merger beginning on page 74, each
Predix stockholder generally will recognize gain, but not loss,
for federal income tax purposes in an amount equal to the lesser
of (a) the amount of cash such Predix stockholder receives
in the merger or (b) the amount, if any, by which the sum
of (i) the fair market value, as of the effective time of
the merger, of any EPIX common stock such Predix stockholder
receives, and (ii) the amount of cash such Predix
stockholder receives in the merger, exceeds such Predix
stockholders adjusted tax basis in its shares of Predix
common stock or preferred stock, as applicable. Any cash
received in lieu of a fractional share of EPIX common stock will
be treated separately for federal income tax purposes. This tax
treatment may not apply to certain Predix stockholders, as
described in The Merger Material United States
Federal Income Tax Consequences of the Merger beginning on
page 74. Determining the actual tax consequences of the
merger to you may be complex and will depend on the facts of
your own situation. You should consult your own tax advisors to
fully understand the tax consequences to you of the merger,
including estate, gift, state, local or
non-U.S. tax
consequences of the merger.
Accounting Treatment of the Merger (See page 74)
EPIX, the acquirer, will account for the merger as a purchase.
Appraisal Rights (See page 78)
Under Delaware law, Predix stockholders are entitled to
appraisal rights in connection with the merger. Please see the
section entitled The Merger Appraisal
Rights on page 78 for more information. As
EPIXs common stock is quoted on The NASDAQ National
Market, EPIX stockholders will not be entitled to appraisal
rights.
Exchange of Predix Stock Certificates (See page 82)
Following the effective time of the merger, EPIX will cause a
letter of transmittal to be mailed to all holders of Predix
common stock and preferred stock containing instructions for
surrendering their
6
certificates. Certificates should not be surrendered until the
letter of transmittal is received, fully completed and returned
as instructed in the letter of transmittal.
Regulatory Approvals (See page 86)
EPIX and Predix are each required to file premerger Notification
and Report forms relating to the merger under the
Hart-Scott-Rodino Act. EPIX must also comply with applicable
federal and state securities laws and the rules and regulations
of The NASDAQ National Market in connection with the issuance of
shares of EPIX common stock in the merger and the filing of this
joint proxy statement/ prospectus with the Securities and
Exchange Commission.
Restrictions on the Ability to Sell EPIX Common Stock (See
page 78)
Subject to the lock-up
agreements described in this joint proxy statement/ prospectus,
all shares of EPIX common stock that Predix stockholders receive
in connection with the merger will be freely transferable unless
you are considered an affiliate of Predix for the purposes of
the Securities Act of 1933, as amended, at the time the merger
agreement is submitted to Predix stockholders for approval and
adoption, in which case you will be permitted to sell the shares
of EPIX common stock you receive in the merger only pursuant to
an effective registration statement or an exemption from the
registration requirements of the Securities Act of 1933, as
amended. The registration statement of which this joint proxy
statement/ prospectus forms a part does not register the resale
of stock received by affiliates of Predix in the merger. EPIX
has agreed to file a registration statement with respect to the
shares of EPIX common stock received by the affiliates of
Predix. As a result, these shares will be freely transferable
upon the effectiveness of the registration statement, subject
only to certain prospectus delivery requirements and the terms
of the lock-up
agreements, if applicable.
Comparison of EPIX and Predix Stockholder Rights (see
page 201)
Upon completion of the merger, Predix stockholders will become
stockholders of EPIX. The internal affairs of EPIX are governed
by EPIXs restated certificate of incorporation and amended
and restated by-laws. The internal affairs of Predix are
currently governed by Predixs restated certificate of
incorporation, as amended, and amended and restated by-laws. Due
to differences between the governing documents of EPIX and
Predix, the merger will result in Predix stockholders having
different rights once they become EPIX stockholders.
7
EPIX SELECTED HISTORICAL FINANCIAL INFORMATION
The following EPIX selected historical financial information
is only a summary and you should read the following financial
information together with EPIX Managements
Discussion and Analysis of Financial Condition and Results of
Operations and EPIXs financial statements and the
notes thereto included elsewhere in this joint proxy statement/
prospectus.
The following tables present EPIXs selected statements of
operations and balance sheet data for the years ended
December 31, 2005, 2004, 2003, 2002 and 2001. EPIX has
derived the following statements of operations data for the
years ended December 31, 2005, 2004 and 2003 and the
balance sheet data as of December 31, 2005 and 2004 from
EPIXs audited financial statements which are included in
this joint proxy statement/ prospectus. EPIX has derived the
following statements of operations data for the years ended
December 31, 2002 and 2001 and the balance sheet data as of
December 31, 2003, 2002 and 2001 from EPIXs audited
financial statements, which are not included in this joint proxy
statement/ prospectus. EPIXs historical results for any
prior period are not necessarily indicative of results to be
expected for any future period.
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Year Ended December 31, | |
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2005 | |
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2004 | |
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2003 | |
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2002 | |
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2001 | |
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(In thousands, except per share data) | |
Statement of Operations Data:
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Revenues
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$ |
7,190 |
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$ |
12,259 |
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$ |
13,525 |
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$ |
12,270 |
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$ |
9,569 |
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Operating loss
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(24,802 |
) |
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|
(20,111 |
) |
|
|
(21,083 |
) |
|
|
(22,816 |
) |
|
|
(18,841 |
) |
Loss before provision for income taxes
|
|
|
(24,269 |
) |
|
|
(20,281 |
) |
|
|
(20,714 |
) |
|
|
(22,098 |
) |
|
|
(18,156 |
) |
Provision for income taxes
|
|
|
42 |
|
|
|
100 |
|
|
|
80 |
|
|
|
94 |
|
|
|
1,092 |
|
Net loss
|
|
|
(24,311 |
) |
|
|
(20,381 |
) |
|
|
(20,795 |
) |
|
|
(22,191 |
) |
|
|
(19,248 |
) |
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
23,258 |
|
|
|
22,889 |
|
|
|
19,056 |
|
|
|
16,878 |
|
|
|
14,007 |
|
Net loss per share, basic and diluted
|
|
$ |
(1.05 |
) |
|
$ |
(0.89 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.31 |
) |
|
$ |
(1.38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$ |
124,728 |
|
|
$ |
164,440 |
|
|
$ |
79,958 |
|
|
$ |
28,112 |
|
|
$ |
24,966 |
|
Working capital
|
|
|
113,098 |
|
|
|
136,653 |
|
|
|
57,011 |
|
|
|
12,364 |
|
|
|
8,277 |
|
Total assets
|
|
|
130,716 |
|
|
|
171,287 |
|
|
|
81,875 |
|
|
|
30,155 |
|
|
|
26,911 |
|
Long-term liabilities
|
|
|
100,756 |
|
|
|
101,210 |
|
|
|
4,331 |
|
|
|
7,829 |
|
|
|
12,844 |
|
Total stockholders equity (deficit)
|
|
|
17,833 |
|
|
|
41,382 |
|
|
|
54,157 |
|
|
|
5,887 |
|
|
|
(3,210 |
) |
8
PREDIX SELECTED HISTORICAL CONSOLIDATED FINANCIAL
INFORMATION
The following Predix selected historical financial
information is only a summary and you should read the following
financial information together with Predix
Managements Discussion and Analysis of Financial Condition
and Results of Operations and Predixs consolidated
financial statements and the notes thereto included elsewhere in
this joint proxy statement/ prospectus.
The following tables present Predixs selected consolidated
statements of operations and balance sheet data for the years
ended December 31, 2005, 2004, 2003, 2002 and 2001. Predix
has derived the following consolidated statements of operations
data for the years ended December 31, 2005, 2004 and 2003
and the consolidated balance sheet data as of December 31,
2005 and 2004 from Predixs audited consolidated financial
statements which are included in this joint proxy statement/
prospectus. Predix has derived the following consolidated
statements of operations data for the years ended
December 31, 2002 and 2001 and the consolidated balance
sheet data as of December 31, 2003, 2002 and 2001 from
Predixs audited consolidated financial statements, which
are not included in this joint proxy statement/ prospectus.
Predixs historical results for any prior period are not
necessarily indicative of results to be expected for any future
period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003(1) | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
2,300 |
|
|
$ |
13 |
|
|
$ |
1,068 |
|
|
$ |
551 |
|
|
$ |
|
|
Operating loss
|
|
|
(34,287 |
) |
|
|
(19,502 |
) |
|
|
(24,696 |
) |
|
|
(11,206 |
) |
|
|
(12,978 |
) |
Income tax benefit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
258 |
|
|
|
|
|
Net loss
|
|
|
(33,703 |
) |
|
|
(19,392 |
) |
|
|
(24,560 |
) |
|
|
(11,241 |
) |
|
|
(11,189 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$ |
7,413 |
|
|
$ |
13,813 |
|
|
$ |
10,999 |
|
|
$ |
21,976 |
|
|
$ |
33,097 |
|
Working capital
|
|
|
1,314 |
|
|
|
11,798 |
|
|
|
9,409 |
|
|
|
21,671 |
|
|
|
31,713 |
|
Total assets
|
|
|
11,799 |
|
|
|
16,717 |
|
|
|
13,462 |
|
|
|
27,098 |
|
|
|
39,568 |
|
Capital lease obligations, net of current portion
|
|
|
109 |
|
|
|
127 |
|
|
|
219 |
|
|
|
32 |
|
|
|
50 |
|
Lease abandonment liability, net of current portion
|
|
|
1,109 |
|
|
|
1,068 |
|
|
|
1,331 |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,248 |
|
|
|
12,470 |
|
|
|
9,906 |
|
|
|
26,140 |
|
|
|
37,623 |
|
|
|
(1) |
In August 2003, Predix acquired all of the capital stock of
Predix Pharmaceuticals Ltd., an Israeli corporation. The
transaction was recorded as a purchase for accounting purposes
and Predixs consolidated statements of operations data
include the operating results of Predix Pharmaceuticals Ltd.
from the date of acquisition. |
|
(2) |
As a result of the acquisition of Predix Pharmaceuticals Ltd.,
Predix consolidated facilities and reduced headcount resulting
in restructuring charges in 2003 of $5.4 million. |
9
EPIX AND PREDIX
UNAUDITED PRO FORMA CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
The following unaudited pro forma condensed consolidated
financial statements give effect to the merger of EPIX and
Predix in a transaction to be accounted for as a purchase by
EPIX. The unaudited pro forma condensed consolidated balance
sheet combines the historical consolidated balance sheets of
EPIX and Predix as of December 31, 2005, giving effect to
the merger as if it occurred on December 31, 2005. The
unaudited pro forma condensed consolidated statement of
operations for the year ended December 31, 2005 assumes the
merger took place on January 1, 2005.
These unaudited pro forma condensed consolidated financial
statements are for informational purposes only. They do not
purport to indicate the results that would have actually been
obtained had the merger been completed on the assumed date or
for the periods presented, or that may be realized in the
future. To produce the unaudited pro forma financial
information, EPIX preliminarily allocated the purchase price
using its best estimates of fair value. These estimates are
based on the most recently available information in preparing a
preliminary value. To the extent there are significant changes
to Predixs business, the assumptions and estimates herein
could change significantly. Furthermore, the parties may have
reorganization and restructuring expenses as well as potential
operating efficiencies as a result of combining the companies.
The pro forma financial information does not reflect these
potential expenses and efficiencies. The unaudited pro forma
condensed consolidated financial statements should be read in
conjunction with EPIX Managements Discussion and
Analysis of Financial Condition and Results of Operations
and Predix Managements Discussion and Analysis of
Financial Condition and Results of Operations and the
historical consolidated financial statements, including the
related notes, of EPIX and Predix, respectively, covering these
periods, included elsewhere in this joint proxy statement/
prospectus.
10
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED BALANCE SHEET
As of December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma | |
|
Note | |
|
Pro Forma | |
|
|
EPIX | |
|
Predix | |
|
Adjustments | |
|
Reference | |
|
Combined | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
72,503 |
|
|
$ |
5,912 |
|
|
|
|
|
|
|
|
|
|
$ |
78,415 |
|
|
Marketable securities
|
|
|
52,226 |
|
|
|
1,501 |
|
|
|
|
|
|
|
|
|
|
|
53,727 |
|
|
Accounts receivable
|
|
|
149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
149 |
|
|
Prepaid expenses and other current assets
|
|
|
347 |
|
|
|
2,016 |
|
|
|
|
|
|
|
|
|
|
|
2,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
125,225 |
|
|
|
9,429 |
|
|
|
|
|
|
|
|
|
|
|
134,654 |
|
Restricted cash
|
|
|
|
|
|
|
931 |
|
|
|
|
|
|
|
|
|
|
|
931 |
|
Property and equipment, net
|
|
|
2,518 |
|
|
|
1,399 |
|
|
|
|
|
|
|
|
|
|
|
3,917 |
|
Other assets
|
|
|
2,973 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
3,013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
130,716 |
|
|
$ |
11,799 |
|
|
|
|
|
|
|
|
|
|
$ |
142,515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
1,268 |
|
|
$ |
2,477 |
|
|
|
|
|
|
|
|
|
|
$ |
3,745 |
|
|
Accrued expenses
|
|
|
4,310 |
|
|
|
4,637 |
|
|
$ |
2,509 |
|
|
|
(B |
) |
|
|
11,456 |
|
|
Contract advances
|
|
|
6,113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,113 |
|
|
Current portion of deferred revenue
|
|
|
436 |
|
|
|
760 |
|
|
|
|
|
|
|
|
|
|
|
1,196 |
|
|
Current portion of capital lease obligations
|
|
|
|
|
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
Current portion of lease abandonment liability
|
|
|
|
|
|
|
152 |
|
|
|
|
|
|
|
|
|
|
|
152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
12,127 |
|
|
|
8,115 |
|
|
|
2,509 |
|
|
|
|
|
|
|
22,751 |
|
|
Accrued rent
|
|
|
|
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
440 |
|
|
Convertible debt
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
Capital lease obligations, net of current portion
|
|
|
|
|
|
|
109 |
|
|
|
|
|
|
|
|
|
|
|
109 |
|
|
Lease abandonment liability, net of current portion
|
|
|
|
|
|
|
1,109 |
|
|
|
|
|
|
|
|
|
|
|
1,109 |
|
|
Deferred revenue, net of current portion
|
|
|
756 |
|
|
|
778 |
|
|
|
|
|
|
|
|
|
|
|
1,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
112,883 |
|
|
|
10,551 |
|
|
|
2,509 |
|
|
|
|
|
|
|
125,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
|
|
|
|
2,732 |
|
|
|
(2,732 |
) |
|
|
(C |
) |
|
|
|
|
|
Common stock
|
|
|
233 |
|
|
|
10 |
|
|
|
205 |
|
|
|
(A |
) |
|
|
438 |
|
|
|
|
|
|
|
|
|
|
|
|
(10 |
) |
|
|
(C |
) |
|
|
|
|
|
Additional paid-in capital
|
|
|
197,311 |
|
|
|
122,200 |
|
|
|
81,398 |
|
|
|
(A |
) |
|
|
288,103 |
|
|
|
|
|
|
|
|
|
|
|
|
4,567 |
|
|
|
(A |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(122,200 |
) |
|
|
(C |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,827 |
|
|
|
(F |
) |
|
|
|
|
|
Deferred compensation
|
|
|
|
|
|
|
(2,294 |
) |
|
|
2,294 |
|
|
|
(C |
) |
|
|
(4,827 |
) |
|
|
|
|
|
|
|
|
|
|
|
(4,827 |
) |
|
|
(F |
) |
|
|
|
|
Accumulated other comprehensive income
|
|
|
(66 |
) |
|
|
(1 |
) |
|
|
1 |
|
|
|
(C |
) |
|
|
(66 |
) |
Accumulated deficit
|
|
|
(179,645 |
) |
|
|
(121,399 |
) |
|
|
121,399 |
|
|
|
(C |
) |
|
|
(267,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
(87,431 |
) |
|
|
(D |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
17,833 |
|
|
|
1,248 |
|
|
|
(2,509 |
) |
|
|
|
|
|
|
16,572 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
130,716 |
|
|
$ |
11,799 |
|
|
$ |
|
|
|
|
|
|
|
$ |
142,515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS
Year Ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma | |
|
Note | |
|
Pro Forma | |
|
|
EPIX | |
|
Predix | |
|
Adjustments | |
|
Reference | |
|
Combined | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product development revenue
|
|
$ |
4,196 |
|
|
$ |
1,737 |
|
|
|
|
|
|
|
|
|
|
$ |
5,933 |
|
|
Royalty revenue
|
|
|
2,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,333 |
|
|
License fee revenue
|
|
|
661 |
|
|
|
563 |
|
|
|
|
|
|
|
|
|
|
|
1,224 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues:
|
|
|
7,190 |
|
|
|
2,300 |
|
|
|
|
|
|
|
|
|
|
|
9,490 |
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
20,776 |
|
|
|
29,351 |
|
|
|
784 |
|
|
|
(G |
) |
|
|
50,911 |
|
|
General and administrative
|
|
|
10,244 |
|
|
|
7,031 |
|
|
|
196 |
|
|
|
(G |
) |
|
|
17,471 |
|
|
Restructuring
|
|
|
972 |
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
1,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
31,992 |
|
|
|
36,587 |
|
|
|
980 |
|
|
|
|
|
|
|
69,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(24,802 |
) |
|
|
(34,287 |
) |
|
|
(980 |
) |
|
|
|
|
|
|
(60,069 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net
|
|
|
4,146 |
|
|
|
614 |
|
|
|
|
|
|
|
|
|
|
|
4,760 |
|
|
Interest expense
|
|
|
(3,613 |
) |
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
|
(3,643 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for income tax
|
|
|
(24,269 |
) |
|
|
(33,703 |
) |
|
|
(980 |
) |
|
|
|
|
|
|
(58,952 |
) |
Provision for income tax
|
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(24,311 |
) |
|
$ |
(33,703 |
) |
|
|
(980 |
) |
|
|
|
|
|
$ |
(58,994 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$ |
(1.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(1.35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares, basic and diluted
|
|
|
23,258 |
|
|
|
|
|
|
|
20,503 |
|
|
|
(E |
) |
|
|
43,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
NOTES TO UNAUDITED PRO FORMA CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
|
|
1. |
Description of Transaction and Basis of Presentation |
On April 3, 2006, EPIX Pharmaceuticals, Inc.
(EPIX) and Predix Pharmaceuticals Holdings, Inc.
(Predix) signed an Agreement and Plan of Merger (the
Merger Agreement) under which Predix will merge with
and into EPIX Delaware, Inc., a wholly-owned subsidiary of EPIX,
in a transaction to be accounted for as a purchase by EPIX. The
assets and liabilities of Predix will be recorded as of the
acquisition date at their estimated fair values. The reported
consolidated financial condition and results of operations of
EPIX after completion of the merger will reflect these values,
but will not be restated retroactively to reflect historical
consolidated financial position or results of operations of
Predix. The transaction is expected to qualify as a
reorganization within the meaning of Section 386(a) of the
Internal Revenue Code. Under the terms of the merger agreement,
each share of Predix common stock and preferred stock (on an
as-converted to Predix common stock basis) outstanding at the
closing of the merger will be exchanged for 1.248509 shares
of EPIX common stock, plus cash in lieu of fractional shares. In
addition, options to purchase Predix capital stock that are
outstanding on the closing date will be assumed by EPIX and will
thereafter constitute an option to acquire the number of shares
of EPIX common stock determined by multiplying the number of
shares of Predix capital stock subject to the option immediately
prior to the merger by 1.248509, rounded down to the nearest
whole share, with an exercise price equal to the exercise price
of the assumed Predix option divided by 1.248509, rounded up to
the nearest whole cent. Each of these options will be subject to
the same terms and conditions that were in effect for the
related Predix options. In addition, EPIX will make a milestone
payment to Predix stockholders and option holders upon the
occurrence of certain events. In no event will the shares of
EPIX common stock issuable at the effective time of the merger,
including the shares issuable upon exercise of Predix options
assumed by EPIX in the merger, exceed 49.99% of the outstanding
EPIX common stock immediately after the effective time of the
merger. In addition, in no event may the milestone be paid in
shares of EPIX common stock to the extent that such shares would
exceed 49.99% of the outstanding shares of EPIX common stock
immediately after such milestone payment, when combined with all
shares of EPIX common stock issued in the merger and issuable
upon exercise of all Predix options assumed by EPIX in the
merger. The merger is subject to customary closing conditions,
including approval by EPIX and Predix shareholders.
A preliminary estimate of the purchase price is as follows (in
thousands):
|
|
|
|
|
Fair value of EPIX shares issued
|
|
$ |
81,603 |
|
Estimated fair value of vested Predix stock options exchanged
for EPIX stock options
|
|
|
4,567 |
|
|
|
|
|
Subtotal
|
|
|
86,170 |
|
Estimated transaction costs incurred by EPIX
|
|
|
2,509 |
|
|
|
|
|
Estimated purchase price
|
|
$ |
88,679 |
|
|
|
|
|
For pro forma purposes, the fair value of the EPIX common stock
used in determining the purchase price was $3.98 per share,
which is the implied price of EPIX common stock based on
(a) the average closing price of EPIX common stock on the
two full trading days immediately preceding the public
announcement of the merger, the trading day the merger was
announced and the two full trading days immediately following
such public announcement and (b) the exchange ratio of
1.248509. The fair value of the EPIX stock options exchanged was
determined by using the Black-Scholes option pricing model with
the following assumptions: stock price of $3.98, which is the
value ascribed to the EPIX common stock in determining the
purchase price; volatility of 70%; risk-free interest rate of
4.62%; and an expected life of 4.9 years.
13
NOTES TO UNAUDITED PRO FORMA CONDENSED
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
For pro forma purposes, the estimated purchase price has been
allocated based on a preliminary valuation of Predixs
tangible and intangible assets and liabilities based on their
estimated fair values as of December 31, 2005 (in
thousands):
|
|
|
|
|
Net tangible assets acquired
|
|
$ |
1,248 |
|
In-process research and development
|
|
|
87,431 |
|
|
|
|
|
Total
|
|
$ |
88,679 |
|
|
|
|
|
The allocation of the purchase price is preliminary. The final
determination of the purchase price allocation will be based on
the fair values of assets acquired, including the fair values of
in-process research and development, other identifiable
intangibles and the fair values of liabilities assumed as of the
date that the merger is consummated.
The purchase price allocation will remain preliminary until EPIX
completes a valuation of significant identifiable intangible
assets acquired (including in-process research and development)
and determines the fair values of the other assets and
liabilities acquired. The final determination of the purchase
price allocation is expected to be completed as soon as
practicable after completion of the merger. The final amounts
allocated to assets and liabilities acquired could differ
significantly from the amounts presented in the unaudited pro
forma condensed consolidated financial statements.
The estimated fair value attributed to in-process research and
development represents an estimate of the fair value of
purchased in-process technology for research projects that, as
of the expected closing date of the merger, will not have
reached technological feasibility and have no alternative future
use. Only those research projects that had advanced to a stage
of development where management believed reasonable net future
cash flow forecasts could be prepared and a reasonable
likelihood of technical success existed were included in the
estimated fair value. Accordingly, the in-process research and
development primarily represents the estimated fair value of
PRX-00023, Predixs drug candidate currently in
Phase III clinical trials for the treatment of generalized
anxiety disorder, PRX-03140, Predixs drug candidate that
has completed Phase I clinical trials for the treatment of
Alzheimers disease, and
PRX-08066,
Predixs drug candidate that has completed Phase I
clinical trials for the treatment of pulmonary hypertension. The
estimated fair value of the in-process research and development
was determined based on a discounted forecast of the estimate
net future cash flows for each project, adjusted for the
estimated probability (for these purposes) of technical success
and U.S. Food and Drug Administration or European Agency
for Evaluation of Medicinal Products approval for each research
project. In-process research and development will be expensed
immediately following completion of the merger.
(A) To record the value of the EPIX common stock and vested
stock options issued in the merger. Cash paid in lieu of
fractional shares will be from existing cash balances and cannot
be estimated at this time.
(B) To record the estimated EPIX transactions costs of
$2.5 million. Transaction costs incurred by Predix will be
expensed as incurred.
(C) To eliminate Predixs historical
stockholders equity accounts.
(D) To record the estimated fair value of in-process
research and development acquired in the merger. Because this
expense is directly attributable to the acquisition and will not
have a continuing impact, it is not reflected in the pro forma
condensed statement of operations. However, this item will be
recorded as an expense immediately following the completion of
the merger.
(E) To record the issuance of EPIX shares to Predix
shareholders to effect the merger.
14
NOTES TO UNAUDITED PRO FORMA CONDENSED
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(F) To record deferred compensation for the fair value of
unvested Predix options exchanged for unvested EPIX options.
(G) To record amortization of deferred compensation
relating to unvested Predix options exchanged for unvested EPIX
options.
The pro forma condensed consolidated financial statements do not
include the $9.5 million debt bridge financing Predix entered
into on March 31, 2006. See Note 14 to Predixs
consolidated financial statements included elsewhere in this
joint proxy statement/prospectus.
|
|
4. |
The Pro Forma Condensed Consolidated Statement of
Operations |
Other than the adjustment to reflect the amortization of
deferred compensation, the pro forma condensed consolidated
statement of operations does not include any pro forma
adjustments as the expense associated with the fair value of the
In Process Research and Development acquired in the merger will
not have a continuing impact, therefore, it is not reflected
above. In addition, the historical costs of the assets and
liabilities acquired in the merger approximate their fair value
as they are the result of fairly recent transactions. As such,
there are no pro forma adjustments to the pro forma condensed
consolidated statement of operations. The final amounts
allocated to assets and liabilities acquired could differ
significantly from the amounts presented in these unaudited pro
forma condensed financial statements.
15
COMPARATIVE PER SHARE DATA
The following table sets forth selected historical share, net
loss per share and book value per share information of EPIX and
unaudited pro forma share, net loss per share and book value per
share information after giving effect to the merger between EPIX
and Predix, assuming that an aggregate of 20,503,259 shares
of EPIX common stock had been issued in exchange for outstanding
shares of Predix common stock and preferred stock (on an
as-converted to Predix common stock basis). You should read this
information in conjunction with the selected historical
financial information included elsewhere in this joint proxy
statement/ prospectus. The unaudited pro forma share, net loss
per share and book value per share information is derived from,
and should be read in conjunction with, the unaudited pro forma
condensed consolidated financial statements and related notes
included elsewhere in this joint proxy statement/ prospectus.
The historical share, net loss per share and book value per
share information is derived from financial statements of EPIX
as of and for the year ended December 31, 2005. The amounts
set forth below are in thousands, except per share amounts.
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 | |
|
|
| |
|
|
EPIX | |
|
|
| |
|
|
Historical | |
|
Pro Forma | |
|
|
| |
|
| |
Basic and diluted net loss per share
|
|
$ |
(1.05 |
) |
|
$ |
(1.35 |
) |
Book value per share
|
|
|
0.77 |
|
|
|
0.38 |
|
|
Shares used in calculating basic and diluted net loss per share
|
|
|
23,258 |
|
|
|
43,761 |
|
Shares used in calculating book value per share
|
|
|
23,285 |
|
|
|
43,788 |
|
16
MARKET PRICE AND DIVIDEND INFORMATION
EPIX
EPIXs common stock currently trades on The NASDAQ National
Market under the symbol EPIX. The following table
shows the high and low sales price for the common stock by
quarter, as reported by The NASDAQ National Market for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Price Range | |
|
|
| |
Period |
|
High | |
|
Low | |
|
|
| |
|
| |
Fiscal Year ended December 31, 2006
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$ |
5.17 |
|
|
$ |
3.33 |
|
|
Fiscal Year Ended December 31, 2005
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$ |
18.18 |
|
|
$ |
6.80 |
|
Second Quarter
|
|
|
9.80 |
|
|
|
6.26 |
|
Third Quarter
|
|
|
10.79 |
|
|
|
7.07 |
|
Fourth Quarter
|
|
|
8.47 |
|
|
|
3.78 |
|
|
Fiscal Year Ended December 31, 2004
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$ |
23.40 |
|
|
$ |
15.94 |
|
Second Quarter
|
|
|
26.37 |
|
|
|
20.34 |
|
Third Quarter
|
|
|
22.58 |
|
|
|
15.80 |
|
Fourth Quarter
|
|
|
20.00 |
|
|
|
15.28 |
|
On March 31, 2006, the last full trading day immediately
preceding the public announcement of the merger, and
on ,
2006, the most recent practicable date prior to the mailing of
this joint proxy statement/ prospectus, the last reported sales
prices of EPIXs common stock, as reported by The NASDAQ
National Market, were $3.50 and
$ per
share, respectively. You are encouraged to obtain current
trading prices for EPIXs common stock in considering
whether to vote to approve the merger. As
of ,
2006, there were
approximately holders
of record of EPIXs common stock. EPIX has not paid cash
dividends on its common stock and has no intention to do so in
the foreseeable future.
Predix
Predixs common stock and preferred stock are not listed
for trading on any securities exchange, and Predix does not
currently file reports with the Securities and Exchange
Commission. As
of ,
2006, there were approximately 118 holders of record of
Predixs common stock and 63 holders of record of
Predixs preferred stock.
Predix has never declared or paid cash dividends on its capital
stock. Predix does not anticipate paying any cash dividends on
its capital stock in the foreseeable future. Predix currently
intends to retain all available funds and any future earnings to
fund the development and growth of its business.
17
CAUTIONARY INFORMATION REGARDING FORWARD-LOOKING
STATEMENTS
This joint proxy statement/ prospectus includes
forward-looking statements within the meaning of the
safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. Words such as
anticipate, believes,
budget, continue, could,
estimate, expect, forecast,
intend, may, plan,
potential, predicts,
project, should, will and
similar expressions are intended to identify such
forward-looking statements. Forward-looking statements in this
joint proxy statement/ prospectus include, without limitation,
statements regarding benefits of the proposed merger and future
expectations concerning available cash and cash equivalents, the
expected timing of the conclusion of clinical trials, the timing
of regulatory filings, and other matters that involve known and
unknown risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements
to differ materially from results expressed in or implied by
this joint proxy statement/ prospectus. Such risk factors
include, among others:
|
|
|
|
|
difficulties encountered in integrating merged businesses; |
|
|
|
uncertainties as to the timing of the merger, approval of the
transaction by the stockholders of the companies and the
satisfaction of closing conditions to the transaction, including
the receipt of regulatory approvals, if any; |
|
|
|
the competitive environment in the life sciences industry; |
|
|
|
whether the companies can successfully develop new products and
the degree to which these gain market acceptance; |
|
|
|
the success and timing of our pre-clinical studies and clinical
trials; |
|
|
|
the companies ability to obtain and maintain regulatory
approval for their product candidates and the timing of such
approvals; |
|
|
|
the companies ability to research, develop and
commercialize their product candidates; |
|
|
|
regulatory developments in the United States and foreign
countries; and |
|
|
|
the companies ability to obtain and maintain intellectual
property protection for their product candidates. |
Actual results may differ materially from those contained in the
forward-looking statements in this joint proxy statement/
prospectus. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the
date of this joint proxy statement/ prospectus. All prior and
subsequent written and oral forward-looking statements
concerning the merger and other matters addressed in this joint
proxy statement/ prospectus and attributable to EPIX or Predix
or any person acting on their behalf are expressly qualified in
their entirety by the cautionary statements included or referred
to in this section. Except to the extent required by applicable
law or regulation, neither EPIX nor Predix undertakes any
obligation to republish revised forward-looking statements to
reflect events and circumstances after the date of this joint
proxy statement/ prospectus or to reflect the occurrence of
unanticipated events.
18
RISK FACTORS
You should consider the following risk factors in evaluating
whether to vote for the approval and adoption of the merger
agreement, the approval of the merger, the approval of the
issuance of the EPIX common stock in the merger and/or the
approval of the amendment to EPIXs restated certificate of
incorporation. These factors should be considered in conjunction
with the other information included in this joint proxy
statement/ prospectus. References to we,
us, our and other first person
declarations in these risk factors refer to the operations of
the combined company following the completion of the merger.
Where we use the words describing either EPIX or Predix, as the
case may be, we are referring to such entity as a stand alone
company or their respective lines of business and industry as
they relate to the combined company.
RISKS RELATING TO THE MERGER
|
|
|
If we are not successful in integrating our organizations,
we may not be able to operate efficiently after the
merger. |
Achieving the benefits of the merger will depend in part on the
successful integration of our operations and personnel in a
timely and efficient manner. The integration process requires
coordination of different development, regulatory, manufacturing
and commercial teams, and involves the integration of systems,
applications, policies, procedures, business processes and
operations. This may be difficult and unpredictable because of
possible cultural conflicts and different opinions on scientific
and regulatory matters. The combination of EPIX and
Predixs organizations may result in greater competition
for resources and the elimination of research and development
programs that might otherwise be successfully completed. If we
cannot successfully integrate our operations and personnel, we
may not realize the expected benefits of the merger.
|
|
|
Integrating our companies may divert managements
attention away from our operations. |
Successful integration of our operations, product candidates and
personnel may place a significant burden on our management and
our internal resources. The diversion of managements
attention and any difficulties encountered in the transition and
integration process could result in delays in the
companies clinical trial programs and could otherwise harm
our business, financial condition and operating results.
|
|
|
We expect to incur significant costs in connection with
the merger and in integrating the companies into a single
business. |
We estimate that EPIX and Predix will incur aggregate direct
transaction costs of approximately $5.5 million associated
with the merger. In addition, we expect to incur significant
costs integrating our operations, product candidates and
personnel, which cannot be estimated accurately at this time.
These costs may include costs for:
|
|
|
|
|
severance; |
|
|
|
conversion of information systems; |
|
|
|
combining development, regulatory, manufacturing and commercial
teams and processes; |
|
|
|
reorganization of facilities; and |
|
|
|
relocation or disposition of excess equipment. |
If the total costs of the merger exceed our estimates, or
benefits of the merger do not exceed the total costs of the
merger, the financial results of the combined company could be
adversely affected.
19
|
|
|
We may be unable to repay, repurchase or redeem
EPIXs 3.0% Convertible Senior Notes due 2024 if, and
when, required. |
The entire $100 million outstanding principal amount of
EPIXs 3.0% Convertible Senior Notes will become due
and payable at maturity in 2024. In addition, noteholders may
require us to repurchase these notes at par, plus accrued and
unpaid interest, on June 15, 2011, 2014 and 2019 and upon
certain other designated events under the notes, which include a
change of control of EPIX or termination of trading of EPIX
common stock on The NASDAQ National Market. The definition of
change in control set forth in the indenture governing the notes
does not include certain mergers and similar transactions that
are not deemed a change in control. While we believe that the
merger does not constitute a change of control of EPIX under the
indenture, we cannot assure you that we will not become
obligated to repurchase these notes, in whole or in part, as a
result of this merger. Based on the current trading price of
EPIXs common stock, we anticipate that in such event most,
if not all, of the noteholders would tender their notes for
repurchase. We may not have enough funds or be able to arrange
for additional financing to repurchase the notes tendered by the
holders upon a designated event or otherwise. Any failure to
repurchase tendered notes would constitute an event of default
under the indenture, which might also constitute a default under
the terms of EPIXs other debt. If we are required to
repurchase or redeem these notes prior to their maturity,
whether as a result of this merger or otherwise, the financial
position of the combined company would be materially adversely
affected and the anticipated benefits of the merger would be
significantly diminished.
|
|
|
If we fail to retain key employees, the benefits of the
merger could be diminished. |
The successful combination of EPIX and Predix will depend in
part on the retention of key personnel. There can be no
assurance that we will be able to retain our key management and
scientific personnel. If we fail to retain such key employees,
particularly those identified in this joint proxy statement/
prospectus as the expected management of the combined company,
we may not realize the anticipated benefits of the merger. The
business of each of EPIX and Predix is also subject to risks
associated with the retention of key employees which are
discussed in greater detail below.
|
|
|
If one or more of the product candidates in the combined
company cannot be shown to be safe and effective in clinical
trials, is not approvable or not commercially successful, then
the benefits of the merger may not be realized. |
The combined company will have five product candidates in the
clinic and several additional product candidates planned to
enter clinical testing in the next several years. All of these
product candidates must be rigorously tested in clinical trials,
and shown to be safe and effective before the U.S. Food and
Drug Administration, or FDA, or its foreign counterparts, will
consider them for approval. Failure to demonstrate that one or
more of the product candidates is safe and effective, or
significant delays in demonstrating safety and efficacy, could
diminish the benefits of the merger. All of these product
candidates must be approved by a government authority such as
the FDA before they can be commercialized. Failure of one or
more of the product candidates to obtain such approval, or
significant delays in obtaining such approval, could diminish
the benefits of the merger. Even if approved for sale, these
product candidates must be successfully commercialized. Failure
to commercialize successfully one or more of these product
candidates could diminish the benefits of the merger.
|
|
|
Because Predix stockholders will receive a fixed number of
shares of EPIX common stock in the merger, rather than a fixed
value, if the market price of EPIX common stock declines, Predix
stockholders will receive consideration in the merger of lesser
value and if the market price of EPIX common stock increases,
EPIX will pay consideration in the merger of greater
value. |
The aggregate number of shares of common stock of EPIX to be
issued to Predix stockholders is fixed. Accordingly, the
aggregate number of shares that Predix stockholders will receive
in the merger will not change, even if the market price of EPIX
common stock changes. In recent years, the stock market in
general, and the securities of biotechnology companies in
particular, including EPIXs securities, have
20
experienced extreme price and volume fluctuations. These market
fluctuations may adversely affect the market price of EPIX
common stock. The market price of EPIX common stock upon and
after the consummation of the merger could be lower than the
market price on the date of the merger agreement or the current
market price, which would decrease the value of the
consideration to be received by Predix stockholders in the
merger. Predix stockholders should obtain recent market
quotations of EPIX common stock before they vote on the merger.
In addition, the market price of EPIX common stock upon and
after the consummation of the merger could be higher than the
market price on the date of the merger agreement or the current
market price. As a result of the fixed number of shares of EPIX
common stock issuable in the merger, increases in the market
price of the EPIX common stock would increase the value of the
consideration payable by EPIX in the merger. EPIX stockholders
should obtain recent market quotations of EPIX common stock
before they vote on the matters set forth in this joint proxy
statement/ prospectus.
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The merger may fail to qualify as a reorganization for
U.S. federal income tax purposes, resulting in recognition
of taxable gain or loss by Predix stockholders in respect of
their Predix stock. |
EPIX and Predix intend for the merger to qualify as a
reorganization within the meaning of Section 368(a) of the
Internal Revenue Code of 1986, as amended. Although the Internal
Revenue Service, or IRS, will not provide a ruling on the
matter, both EPIX and Predix will, as a condition to closing,
obtain a legal opinion from their respective tax counsel that
the merger will constitute a reorganization for
U.S. federal income tax purposes. These opinions do not
bind the IRS, nor do they prevent the IRS from adopting a
contrary position. If the merger fails to qualify as a
reorganization, each Predix stockholder will generally recognize
gain or loss on each share of Predix common stock or preferred
stock exchanged in the merger in an amount equal to the
difference between such Predix stockholders adjusted tax
basis in that share and the sum of the amount of cash and the
fair market value of EPIX common stock received in exchange for
that share upon completion of the merger. In addition, the
merger would be treated as a sale of all of the assets of Predix
to EPIX, with a corporate level tax liability owed by EPIX for
the period in which the merger occurs. Such a tax liability may
be significant and could have a material adverse effect on the
financial position of the combined company.
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Failure to complete the merger could adversely affect
EPIXs stock price and EPIXs and Predixs future
business and operations. |
The merger is subject to the satisfaction of various closing
conditions, including the approval by both EPIX and Predix
stockholders, and neither EPIX nor Predix can guarantee that the
merger will be successfully completed. In the event that the
merger is not consummated, EPIX and Predix will be subject to
many risks, including the costs related to the merger, such as
legal, accounting and advisory fees, which must be paid even if
the merger is not completed, or the payment of a termination fee
under certain circumstances. If the merger is not consummated,
the market price of EPIX common stock could decline.
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Certain directors and management of EPIX and Predix may
have interests that are different from, or in addition to, those
of the respective EPIX and Predix stockholders generally. |
The directors and management of EPIX and Predix may have
interests in the merger that are different from, or are in
addition to, those of the respective EPIX and Predix
stockholders generally, including the following:
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Upon the closing of the merger, Christopher F.O. Gabrieli,
Michael Gilman, Ph.D., Mark Leuchtenberger and Gregory D.
Phelps, each of whom is a current director of EPIX, is expected
to be a member of the combined companys board of directors. |
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It is anticipated that certain current officers and key
employees of EPIX, including Andrew C.G. Uprichard, M.D., Thomas
McMurry, Ph.D., Robert Pelletier, CPA, Philip Graham, Ph.D., and
Brenda Sousa, will be executive officers or key employees of the
combined company. |
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Upon completion of the merger, certain current officers of EPIX
are entitled to bonuses. Robert Pelletier, Executive Director of
Finance, and Brenda Sousa, Vice President of Human Resources,
are entitled to a bonus of $48,667 and $47,500, respectively. In
addition, Philip Chase, Vice President and General Counsel is
entitled to a bonus of $72,000 upon completion of the merger. |
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Upon the closing of the merger, the executive officers of the
Predix, including Michael G.
Kauffman, M.D., Ph.D., Silvia Noiman, Ph.D., Oren
Becker, Ph.D., Chen Schor, CPA and Kimberlee C.
Drapkin, CPA, will become executive officers of the combined
company. |
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EPIX will maintain all rights to indemnification existing in
favor of Predix directors and officers for their acts and
omissions occurring prior to the completion of the merger and
will maintain the directors and officers liability
insurance to cover any such liabilities for six years following
the completion of the merger. |
In addition, you should be aware that Frederick Frank,
Michael G. Kauffman, M.D., Ph.D., Patrick J. Fortune, Ph.D.
and Ian F. Smith, CPA, ACA will have a relationship with
both EPIX and Predix due to their positions as current directors
of Predix and future directors of EPIX. Moreover,
Mr. Frank, the Chairman of the Predix board of directors,
is also the Vice Chairman and a director of Lehman Brothers
Inc., Predixs financial advisor in connection with the
merger. Lehman Brothers is entitled to certain fees and expenses
from Predix upon consummation of the merger. See the section
entitled The Merger Interests of Predixs
Directors and Management in the Merger and Current
Management of Predix and Related Information Certain
Transactions with Management and Affiliates.
These interests may influence these directors in making their
recommendation that you vote in favor of the approval and
adoption of the merger agreement, the approval of the merger
and/or the approval of the amendment to EPIXs restated
certificate of incorporation. You should be aware of these
interests when you consider the respective Predix and EPIX
boards of directors recommendations that you vote in favor
of the approval and adoption of the merger agreement, the
approval of the merger and/or the approval of the amendment to
EPIXs restated certificate of incorporation.
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EPIX and Predix stockholders will have a reduced ownership
and voting interest after the merger and will exercise less
influence over management of the combined company following the
merger. |
After the merger, the stockholders of each of EPIX and Predix
will own a significantly smaller percentage of the combined
company than their respective ownership of Predix and EPIX. At
the effective time of the merger, EPIX stockholders will as of
the date of the merger agreement, own approximately 53% of the
outstanding shares of the combined company and Predix
stockholders will collectively own approximately 47% of the
outstanding shares of the combined company, based on the number
of shares of EPIX common stock and Predix common stock and
preferred stock outstanding as of the date of the merger
agreement. Consequently, stockholders of EPIX and Predix will be
able to exercise less influence over the management and policies
of the combined company that they currently exercise over the
management and policies of their respective companies.
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Future sales of common stock by existing EPIX and Predix
stockholders may cause the stock price of the combined company
to fall. |
The market price of our common stock could decline as a result
of sales by existing EPIX stockholders and former Predix
stockholders in the market after the completion of the merger,
or the perception that these sales could occur. These sales
might also make it more difficult for the combined company to
sell equity securities at an appropriate time and price.
22
RISKS RELATING TO THE COMBINED COMPANY
Risks Relating to the Business
of EPIX and the Combined Company
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Research and Development Risks |
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EPIX may never receive marketing approval for any of its
product candidates in the United States, including Vasovist and
EP-2104R. |
EPIX is not able to market any of its product candidates in the
United States, Europe or in any other jurisdiction without
marketing approval from the FDA, the European Commission, or any
equivalent foreign regulatory agency. The regulatory process to
obtain marketing approval for a new drug or biologic takes many
years and requires the expenditure of substantial resources.
This process can vary substantially based on the type,
complexity, novelty and indication of the product candidate
involved.
Although the EMEA granted approval of Vasovist for all 25 member
states of the E.U. in October 2005, Vasovist has not been
approved in the United States. In December 2003, EPIX submitted
a new drug application, or NDA, for Vasovist to the FDA, and in
June 2004, EPIXs development partner Schering AG submitted
a Marketing Authorization Application, or MAA, to the European
Medicines Agency, or EMEA. In January 2005, EPIX received an
approvable letter from the FDA for Vasovist in which the FDA
requested additional clinical trials prior to approval. In May
2005, EPIX submitted a response to the FDA approvable letter,
which was accepted by the FDA as a complete response in June
2005. In November 2005, the FDA provided EPIX with a second
approvable letter. Although no safety or manufacturing issues
were raised in the second approvable letter, the second
approvable letter indicated that at least one additional
clinical trial and a re-read of images obtained in certain
previously completed Phase III trials will be necessary
before the FDA could approve Vasovist. EPIX believes that these
trials would require a substantial period of time to complete.
EPIX has had two meetings with the FDA since receiving the
second approval letter to discuss the path forward for Vasovist
in the United States and EPIX is currently considering all
of its options, including formally appealing the FDAs
decision to require an additional clinical trial and/or
conducting one or more additional clinical trials. The approval,
timeliness of approval or labeling of Vasovist are subject to
significant uncertainties related to a number of factors,
including the process of reaching agreement with the FDA on the
clinical data and on any clinical trial protocol required for
regulatory approval of Vasovist, the timing and process of
conducting any clinical trials required, obtaining the desired
outcomes of any required clinical trials and the FDAs
review process and conclusions regarding any additional Vasovist
regulatory submissions. EPIX cannot assure you that it will be
able to reach agreement with the FDA on the design or clinical
endpoints required for additional clinical trials or re-read of
images from the Phase III trials. Further, EPIX cannot
assure you that any such agreed upon clinical trials will be
feasible for EPIX to conduct or whether such trials will be
completed in a commercially reasonable timeframe, if at all. Any
further clinical trials that are required could take several
years to complete.
If the FDA does not approve Vasovist, then EPIX will not receive
revenues based on sales of Vasovist in the United States. Even
if ultimately approved, EPIX does not expect revenues from the
commercial sales of any of its product candidates, other than
Vasovist, for at least several years.
EPIX completed a feasibility clinical trial of EP-2104R.
EPIXs partner, Schering AG, has an option to exclusively
license EP-2104R. The exercisability of this option will
continue for a specified period of time after the submission of
a report summarizing the results of this clinical trial. If the
results of the clinical trial are positive and Schering AG
exercises its option to exclusively license the product
candidate, then EPIX will be eligible for milestone payments for
certain clinical and regulatory achievements and a royalty after
the product candidate is commercialized. However, if the results
are not sufficiently promising, Schering AG may decline to
exercise its option, in which case EPIX may bear the expenses of
further clinical development itself. Regardless of whether
Schering AG exercises its option to license EP-2104R, the FDA,
the EMEA and other regulatory agencies to which EPIX or Schering
AG submit applications for marketing authorization may not agree
that EPIXs product candidate is safe and effective
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and may not approve EPIXs product candidate, in which case
EPIXs ability to receive any milestone payments or royalty
payments related to EP-2104R will be significantly reduced.
The relevant regulatory authorities may not approve any of
EPIXs applications for marketing authorization relating to
any of its product candidates, including Vasovist and EP-2104R,
or additional applications for or variations to marketing
authorizations that EPIX may make in the future as to these or
other product candidates. Among other things, EPIX has had only
limited experience in preparing applications and obtaining
regulatory approvals. If approval is granted, it may be subject
to limitations on the indicated uses for which the product
candidate may be marketed or contain requirements for costly
post-marketing testing and surveillance to monitor safety or
efficacy of the product candidate. If approval of an application
to market product candidates is not granted on a timely basis or
at all, or if EPIX is unable to maintain its approval,
EPIXs business may be materially harmed.
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If EPIXs clinical trials are not successful, EPIX
may not be able to develop and commercialize its product
candidates. |
To obtain regulatory approvals for the commercial sale of
EPIXs potential products, EPIX and its partners will be
required to complete extensive clinical trials in humans to
demonstrate the safety and efficacy of its product candidates.
Vasovist and EP-2104R are currently EPIXs only product
candidates that have undergone human clinical trials and EPIX
cannot be certain that any of its other research projects will
yield a product candidate suitable for substantial human
clinical testing.
With respect to both EPIXs current product candidates in
human clinical trials and its research product candidates which
may be suitable for testing in human clinical trials at some
point in the future, EPIX may not be able to commence or
complete the required clinical trials in any specified time
period, or at all, either because the FDA or other regulatory
agencies object, because EPIX is unable to attract or retain
clinical trial participants, or for other reasons.
Even if EPIX completes a clinical trial of one of its potential
products, the data collected from the clinical trial may not
demonstrate that its product candidate is safe or effective to
the extent required by the FDA, the EMEA, or other regulatory
agencies to approve the potential product candidate, or at all.
For example, in January and November 2005, the FDA informed EPIX
that the data for Vasovist that EPIX submitted in connection
with its NDA was not adequate for approval.
The results from pre-clinical testing of a product candidate
that is under development may not be predictive of results that
will be obtained in human clinical trials. In addition, the
results of early human clinical trials may not be predictive of
results that will be obtained in larger scale, advanced-stage
clinical trials. Furthermore, EPIX, one of its collaborators, or
a regulatory agency with jurisdiction over the trials may
suspend clinical trials at any time if the patients
participating in such trials are being exposed to unacceptable
health risks, or for other reasons.
The timing of completion of clinical trials is dependent in part
upon the rate of enrollment of patients. Patient accrual is a
function of many factors, including the size of the patient
population, the proximity of patients to clinical sites, the
eligibility criteria for the trial, the existence of competitive
clinical trials, and the availability of alternative treatments.
Delays in planned patient enrollment may result in increased
costs and prolonged clinical development. In addition, patients
may withdraw from a clinical trial for a variety of reasons. If
EPIX fails to accrue and maintain the number of patients into
one of its clinical trials for which the clinical trial was
designed, the statistical power of that clinical trial may be
reduced which would make it harder to demonstrate that the
product candidates being tested in such clinical trial are safe
and effective.
Regulatory authorities, clinical investigators, institutional
review boards, data safety monitoring boards and the hospitals
at which EPIXs clinical trials are conducted all have the
power to stop EPIXs clinical trials prior to completion.
If EPIXs trials are not completed, EPIX would be unable to
show the safety and efficacy required to obtain marketing
authorization for its product candidates.
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If EPIX fails to comply with the extensive regulatory
requirements to which it and its product candidates are subject,
EPIXs product candidates could be subject to restrictions
or withdrawal from the market and EPIX could be subject to
penalties. |
EPIX is subject to extensive U.S. and foreign governmental
regulatory requirements and lengthy approval processes for its
product candidates. The development and commercial use of
EPIXs product candidates will be regulated by numerous
federal, state, local and foreign governmental authorities in
the United States, including the FDA and foreign regulatory
agencies. The nature of EPIXs research and development and
manufacturing processes requires the use of hazardous substances
and testing on certain laboratory animals. Accordingly, EPIX is
subject to extensive federal, state and local laws, rules,
regulations and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling
and disposal of certain materials and wastes as well as the use
of and care for laboratory animals. If EPIX fails to comply or
if an accident occurs, EPIX may be exposed to legal risk and be
required to pay significant penalties or be held liable for any
damages that result. Such liability could exceed EPIXs
financial resources. Furthermore, current laws could change and
new laws could be passed that may force EPIX to change its
policies and procedures, an event which could impose significant
costs on EPIX.
Specifically, Vasovist and EP-2104R are regulated by the FDA as
drugs. Under the Food, Drug and Cosmetic Act and the FDAs
implementing regulations, the FDA regulates the research,
development, manufacture and marketing, among other things, of
pharmaceutical products. The process required by the FDA before
Vasovist and EPIXs other product candidates may be
marketed in the United States typically involves the performance
of pre-clinical laboratory and animal tests; submission of an
investigational new drug application, or IND; completion of
human clinical trials; submission of an NDA to the FDA; and FDA
approval of an NDA.
This regulatory approval process is lengthy and expensive.
Although some of EPIXs employees have experience in
obtaining regulatory approvals, EPIX has only limited experience
in filing or pursuing applications necessary to gain regulatory
approvals. Pre-clinical testing of EPIXs product
development candidates is subject to good laboratory practices,
as prescribed by the FDA, and the manufacture of any products
developed by EPIX will be subject to current good manufacturing
practices, as prescribed by the FDA, or cGMP. EPIX may not
obtain the necessary FDA approvals and subsequent approvals in a
timely manner, if at all. EPIX cannot be sure as to the length
of the clinical trial period or the number of patients that will
be required to be tested in the clinical trials in order to
establish the safety and efficacy of Vasovist for regulatory
approval in the United States or any of its future product
candidates. For example, EPIX has received two approvable
letters from the FDA and has had two meetings with the FDA to
discuss the path forward for Vasovist in the United States and
EPIX is currently considering all of its options, including
appealing the FDAs decision to require an additional
clinical trial and/or conducting one or more additional clinical
trials. EPIX cannot predict whether an appeal or additional
trials would be completed timely or successfully. EPIXs
clinical trials may not be successful and EPIX may not complete
them in a timely manner. EPIX could report serious side effects
as the clinical trials proceed. EPIXs results from early
clinical trials may not predict results that it obtains in later
clinical trials, even after promising results in earlier trials.
The rate of completion of EPIXs clinical trials depends
upon, among other things, the rate of patient enrollment and
subsequent blinded reading of images and data analysis.
Furthermore, EPIX, or the FDA or other regulatory authorities
may suspend or terminate clinical trials at any time, including
terminating clinical trials for safety reasons. In addition, the
FDA may suggest or require alterations to clinical trials at any
time. For example, in September 2001, after discussions with the
FDA, EPIX expanded its initial target indication for Vasovist
from one specific body region, the aortoiliac region, to a
broader indication that included the entire bodys vascular
system, except for the heart. This expansion required EPIX to
add two new clinical trials to its then existing Phase III
clinical trial program; one to determine the efficacy of
Vasovist-enhanced magnetic resonance angiography, or MRA, for
the detection of vascular disease in the renal arteries, and
another to determine the efficacy of Vasovist-enhanced MRA for
the detection of vascular disease in the pedal arteries.
Although providing
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EPIX with greater market potential for the sale of Vasovist upon
approval, this change to the Phase III clinical trial
program and the associated delay in the startup of new clinical
centers resulted in an approximate
15-month delay in
EPIXs NDA submission and an increase in costs associated
with the program. If EPIX does not successfully complete
clinical trials for its product candidates, it will not be able
to market these product candidates.
In addition, EPIX may encounter unanticipated delays or
significant costs in its efforts to secure necessary approvals.
EPIXs analysis of data obtained from pre-clinical and
clinical activities is subject to confirmation and
interpretation by regulatory authorities which could delay,
limit or prevent FDA regulatory approval. In addition, the FDA
may require EPIX to modify its future clinical trial plans or to
conduct additional clinical trials in ways that it cannot
currently anticipate, resulting in delays in its obtaining
regulatory approval. Delays in obtaining government regulatory
approval could adversely affect EPIXs, or its
partners, marketing as well as the ability to generate
significant revenues from commercial sales.
Future U.S. legislative or administrative actions also
could prevent or delay regulatory approval of EPIXs
product candidates. Even if EPIX obtains regulatory approvals,
they may include significant limitations on the indicated uses
for which EPIX may market a product. A marketed product also is
subject to continual FDA and other regulatory agency review and
regulation. Later discovery of previously unknown problems or
failure to comply with the applicable regulatory requirements
may result in restrictions on the marketing of a product or
withdrawal of the product from the market as well as possible
civil or criminal sanctions. Further, many academic institutions
and companies conducting research and clinical trials in the
magnetic resonance imaging, or MRI, contrast agent field are
using a variety of approaches and technologies. If researchers
obtain any adverse results in pre-clinical studies or clinical
trials, it could adversely affect the regulatory environment for
MRI contrast agents in general. In addition, if EPIX obtains
marketing approval, the FDA may require post-marketing testing
and surveillance programs to monitor the products efficacy
and side effects. Results of these post-marketing programs may
prevent or limit the further marketing of the monitored product.
If EPIX, or its partners, such as Schering AG, cannot
successfully market EPIXs product candidates, EPIX will
not generate sufficient revenues to achieve or maintain
profitability.
EPIX and its strategic partners are also subject to numerous and
varying foreign regulatory requirements governing the design and
conduct of clinical trials and the manufacturing and marketing
of EPIXs product candidates. The foreign regulatory
approval process may include all of the risks associated with
obtaining FDA approval set forth above and EPIX may not obtain
foreign regulatory approvals on a timely basis, if at all,
thereby compromising its ability to market its product
candidates abroad.
In addition, the testing, manufacturing, labeling, advertising,
promotion, export and marketing, among other things, of
EPIXs product candidates, both before and after approval,
are subject to extensive regulation by governmental authorities
in the United States, Europe and elsewhere throughout the world.
Failure to comply with the law administered by the FDA, the
EMEA, or other governmental authorities could result in any of
the following:
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delay in approval or refusal to approve a product candidate; |
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product candidate recall or seizure; |
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interruption of production; |
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operating restrictions; |
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warning letters; |
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injunctions; |
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criminal prosecutions; and |
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unanticipated expenditures. |
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EPIX is required to maintain pharmacovigilance systems for
collecting and reporting information concerning suspected
adverse reactions to its product candidates. In response to
pharmacovigilance reports, regulatory authorities may initiate
proceedings to revise the prescribing information for
EPIXs product candidates or to suspend or revoke its
marketing authorizations. Procedural safeguards are often
limited, and marketing authorizations can be suspended with
little or no advance notice.
Both before and after approval of a product, quality control and
manufacturing procedures must conform to cGMP. Regulatory
authorities, including the EMEA and the FDA, periodically
inspect manufacturing facilities to assess compliance with cGMP.
Accordingly, EPIX and its contract manufacturers will need to
continue to expend time, funds, and effort in the area of
production and quality control to maintain cGMP compliance.
In addition to regulations adopted by the EMEA, the FDA, and
other foreign regulatory authorities, EPIX is also subject to
regulation under the Occupational Safety and Health Act, the
Toxic Substances Control Act, the Resource Conservation and
Recovery Act, and other federal, state, and local regulations.
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EPIXs research and development efforts may not
result in product candidates appropriate for testing in human
clinical trials. |
EPIX has historically spent significant resources on research
and development and pre-clinical studies of product candidates.
However, these efforts may not result in the development of
product candidates appropriate for testing in human clinical
trials. For example, EPIXs research may result in product
candidates that are not expected to be effective in treating
diseases or may reveal safety concerns with respect to product
candidates. In connection with EPIXs recent restructuring,
it postponed or terminated several research and development
programs, and it may postpone or terminate research and
development of a product candidate or a program at any time for
any reason such as the safety or effectiveness of the potential
product, allocation of resources or unavailability of qualified
research and development personnel. The failure to generate
high-quality research and development candidates would
negatively impact EPIXs ability to advance product
candidates into human clinical testing and ultimately,
negatively impact its ability to market and sell products.
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EPIX has have a limited manufacturing capability and it
intends to outsource manufacturing of Vasovist to third parties,
who may not perform as EPIX expects. |
EPIX does not have, nor does it currently have plans to develop,
full-scale manufacturing capability for Vasovist. While EPIX has
manufactured small amounts of Vasovist for research and
development efforts, it relies on, and it intends to continue to
rely on, Tyco/ Mallinckrodt as the primary manufacturer of
Vasovist for any future human clinical trials and commercial
use. Together with Schering AG, EPIX is considering alternative
manufacturing arrangements for Vasovist for commercial use,
including the transfer of manufacturing to Schering AG. In the
event that Tyco/ Mallinckrodt fails to fulfill its manufacturing
responsibilities satisfactorily, Schering AG has the right to
purchase Vasovist from a third party or to manufacture the
compound itself. However, either course of action could
materially delay the manufacture and development of Vasovist.
Schering AG may not be able to find an alternative manufacturer.
In addition, Schering AG may not be able to manufacture Vasovist
itself in a timely manner or in sufficient quantities. If EPIX
experiences a delay in manufacturing, it could result in a delay
in the approval or commercialization of Vasovist and have a
material adverse effect on its business, financial condition and
results of operations.
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If MRI manufacturers are not able to enhance their
hardware and software sufficiently, EPIX will not be able to
complete development of its contrast agent for the evaluation of
cardiac indications. |
Although MRI hardware and software is sufficient for the
evaluation of non-coronary vascular disease, which is
EPIXs initial target indication, EPIX believes that the
technology is not as advanced for cardiac applications.
EPIXs initial NDA filing for Vasovist is related to
non-coronary vascular disease. Based on
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feasibility studies EPIX completed in 2001, however, the imaging
technology available for cardiac applications, including
coronary angiography and cardiac perfusion imaging, was not
developed to the point where there was clear visualization of
the cardiac region due to the effects of motion from breathing
and from the beating of the heart. In 2004, EPIX initiated
Phase II feasibility trials of Vasovist for cardiac
indications using available software and hardware that can be
adapted for coronary and cardiac perfusion data acquisition, and
preliminary review of the data indicates that EPIX has not
resolved the technical issues related to this use of Vasovist.
EPIX has collaborated with a number of leading academic
institutions and with GE Healthcare, Siemens Medical Systems and
Philips Medical Systems to help optimize cardiac imaging with
Vasovist. EPIX does not know when, or if, these techniques will
enable Vasovist to provide clinically relevant images in cardiac
indications. If MRI device manufacturers are not able to enhance
their scanners to perform clinically useful cardiac imaging,
EPIX will not be able to complete its development activities of
Vasovist for that application, thereby reducing the potential
market for a product in this area.
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EPIX depends on exclusively licensed technology from the
Massachusetts General Hospital and if EPIX loses this license,
it is unlikely it could obtain this technology elsewhere, which
would have a material adverse effect on EPIXs
business. |
Under the terms of a license agreement that EPIX has with the
Massachusetts General Hospital, or MGH, EPIX is the exclusive
licensee to certain technology, which relate to royalties it
receives and to Vasovist. The license agreement imposes various
commercialization, sublicensing, royalty and other obligations
on EPIX. If EPIX fails to comply with these and other
requirements, its license could convert from exclusive to
nonexclusive, or terminate entirely. It is unlikely that EPIX
would be able to obtain this technology elsewhere. Any such
event would mean that EPIX would not receive royalties from
Bracco for MultiHance or Schering AG for Primovist, and that
EPIX or Schering AG could not sell Vasovist, either of which
would have a material adverse effect on EPIXs business,
financial condition and results of operations. Currently, EPIX
believes it is in compliance with the terms of the license
agreement and its does not have any reason to believe that this
license may be terminated.
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EPIX depends on patents and other proprietary rights, and
if they fail to protect its business, EPIX may not be able to
compete effectively. |
The protection of EPIXs proprietary technologies is
material to its business prospects. EPIX pursues patents for its
product candidates in the United States and in other countries
where it believes that significant market opportunities exist.
EPIX owns or has an exclusive license to patents and patent
applications on aspects of its core technology as well as many
specific applications of this technology. Even though EPIX holds
numerous patents and has made numerous patent applications,
because the patent positions of pharmaceutical and
biopharmaceutical firms, including EPIXs patent positions,
generally include complex legal and factual questions,
EPIXs patent positions remain uncertain. For example,
because most patent applications are maintained in secrecy for a
period after filing, EPIX cannot be certain that the named
applicants or inventors of the subject matter covered by its
patent applications or patents, whether directly owned or
licensed to EPIX, were the first to invent or the first to file
patent applications for such inventions. Third parties may
oppose, challenge, infringe upon, circumvent or seek to
invalidate existing or future patents owned by or licensed to
EPIX. A court or other agency with jurisdiction may find
EPIXs patents invalid, not infringed or unenforceable and
EPIX cannot be sure that patents will be granted with respect to
any of its pending patent applications or with respect to any
patent applications filed by it in the future. Even if EPIX has
valid patents, these patents still may not provide sufficient
protection against competing products or processes. If EPIX is
unable to successfully protect its proprietary methods and
technologies, or if its patent applications do not result in
issued patents, EPIX may not be able to prevent other companies
from practicing its technology and, as a result, its competitive
position may be harmed.
28
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EPIX may need to initiate lawsuits to protect or enforce
its patents and other intellectual property rights, which could
result in its incurrence of substantial costs and which could
result in the forfeiture of these rights. |
EPIX may need to bring costly and time-consuming litigation
against third parties in order to enforce its issued patents,
protect its trade secrets and know how, or to determine the
enforceability, scope and validity of proprietary rights of
others. In addition to being costly and time-consuming, such
lawsuits could divert managements attention from other
business concerns. These lawsuits could also result in the
invalidation or a limitation in the scope of EPIXs patents
or forfeiture of the rights associated with its patents or
pending patent applications. EPIX may not prevail and a court
may find damages or award other remedies in favor of an opposing
party in any such lawsuits. During the course of these suits,
there may be public announcements of the results of hearings,
motions and other interim proceedings or developments in the
litigation. Securities analysts or investors may perceive these
announcements to be negative, which could cause the market price
of EPIXs stock to decline. In addition, the cost of such
litigation could have a material adverse effect on EPIXs
business and financial condition.
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Other rights and measures that EPIX relies upon to protect
its intellectual property may not be adequate to protect its
products and services and could reduce its ability to compete in
the market. |
In addition to patents, EPIX relies on a combination of trade
secrets, copyright and trademark laws, non-disclosure agreements
and other contractual provisions and technical measures to
protect its intellectual property rights. While EPIX requires
employees, collaborators, consultants and other third parties to
enter into confidentiality and/or non-disclosure agreements,
where appropriate, any of the following could still occur:
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the agreements may be breached; |
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EPIX may have inadequate remedies for any breach; |
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proprietary information could be disclosed to EPIXs
competitors; or |
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others may independently develop substantially equivalent
proprietary information and techniques or otherwise gain access
to EPIXs trade secrets or disclose such technologies. |
If, as a result of the foregoing or otherwise, EPIXs
intellectual property is disclosed or misappropriated, it would
harm EPIXs ability to protect its rights and its
competitive position. Moreover, several of EPIXs
management and scientific personnel were formerly associated
with other pharmaceutical and biotechnology companies and
academic institutions. In some cases, these individuals are
conducting research in similar areas with which they were
involved prior to joining EPIX. As a result, EPIX, as well as
these individuals, could be subject to claims of violation of
trade secrets and similar claims.
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EPIXs success will depend partly on its ability to
operate without infringing the intellectual property rights of
others, and if EPIX is unable to do so, it may not be able to
sell its products. |
EPIXs commercial success will depend, to a significant
degree, on its ability to operate without infringing upon the
patents of others in the United States and abroad. There may be
pending or issued patents held by parties not affiliated with
EPIX relating to technologies EPIX uses in the development or
use of certain of its contrast agents. If any judicial or
administrative proceeding upholds these or any third- party
patents as valid and enforceable, EPIX could be prevented from
practicing the subject matter claimed in such patents, or would
be required to obtain licenses from the owners of each such
patent, or to redesign its product candidates or processes to
avoid infringement. For example, in November 2003, EPIX entered
into an intellectual property agreement with Dr. Martin R.
Prince, an early innovator in the field of MRA, relating to
dynamic MRA, which involves capturing MRA images
during the limited time, typically 30 to 60 seconds, available
for imaging with extracellular agents. Under the terms of the
intellectual property agreement, Dr. Prince made certain
covenants and agreements and granted EPIX certain discharges,
licenses and releases in connection with the use of Vasovist. In
consideration of
29
Dr. Prince entering into the agreement, EPIX agreed to pay
him an upfront fee and royalties on sales of Vasovist consistent
with a non-exclusive early stage academic license and agreed to
deliver to him 132,000 shares of EPIXs common stock
and certain quantities of Vasovist. If EPIX is unable to obtain
a required license on acceptable terms, or are unable to design
around these or any third-party patents, it may be unable to
sell its products, which would have a material adverse effect on
its business.
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If EPIX fails to get adequate levels of reimbursement from
third-party payors for its product candidates after they are
approved in the United States and abroad, EPIX may have
difficulty commercializing its product candidates. |
EPIX believes that reimbursement in the future will be subject
to increased restrictions, both in the United States and in
foreign markets. EPIX believes that the overall escalating cost
of medical products and services has led to, and will continue
to lead to, increased pressures on the health care industry,
both foreign and domestic, to reduce the cost of products and
services, including products offered by it. There can be no
assurance, in either the United States or foreign markets, that
third-party reimbursement will be available or adequate, that
current reimbursement amounts will not be decreased in the
future or that future legislation, regulation, or reimbursement
policies of third-party payors will not otherwise adversely
affect the demand for EPIXs product candidates or its
ability to sell its product candidates on a profitable basis,
particularly if MRI exams enhanced with EPIXs contrast
agents are more expensive than competing vascular imaging
techniques that are equally effective. The unavailability or
inadequacy of third-party payor coverage or reimbursement could
have a material adverse effect on EPIXs business,
financial condition and results of operations.
EPIX could be adversely affected by changes in reimbursement
policies of governmental or private healthcare payors,
particularly to the extent any such changes affect reimbursement
for procedures in which its product candidates would be used.
Failure by physicians, hospitals and other users of EPIXs
product candidate to obtain sufficient reimbursement from
third-party payors for the procedures in which EPIXs
product candidate would be used or adverse changes in
governmental and private third-party payors policies
toward reimbursement for such procedures may have a material
adverse effect on EPIXs ability to market its product
candidate and, consequently, it could have an adverse effect on
EPIXs business, financial condition and results of
operations. If EPIX obtains the necessary foreign regulatory
approvals, market acceptance of its product candidates in
international markets would be dependent, in part, upon the
availability of reimbursement within prevailing healthcare
payment systems. Reimbursement and healthcare payment systems in
international markets vary significantly by country, and include
both government sponsored health care and private insurance.
EPIX and its strategic partners intend to seek international
reimbursement approvals, although EPIX cannot assure you that
any such approvals will be obtained in a timely manner, if at
all, and failure to receive international reimbursement
approvals could have an adverse effect on market acceptance of
EPIXs product candidate in the international markets in
which such approvals are sought.
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If EPIX is unable to attract and retain key management and
other personnel, it would hurt EPIXs ability to
compete. |
EPIXs future business and operating results depend in
significant part upon its ability to attract and retain
qualified directors, senior management and key technical
personnel. In September 2005, the EPIX board of directors
appointed Michael J. Astrue as Interim Chief Executive Officer.
Mr. Astrue replaced Michael Webb, who resigned from EPIX
and its board of directors in September 2005. Mr. Astrue
intends to resign as Interim Chief Executive Officer in May
2006. In addition, EPIXs Chief Financial Officer resigned
in July 2005. EPIX currently has no Chief Financial Officer and
its Executive Director, Finance, is serving as its principal
financial and accounting officer. Christopher F.O. Gabrieli, the
Chairman of the EPIX board of directors, is a candidate for the
Governor of the Commonwealth of Massachusetts, the general
election for which is scheduled in November 2006. If elected,
Mr. Gabrieli will step down from the EPIX board of
directors. EPIXs inability to attract and retain qualified
individuals to these positions and others, the loss of any of
EPIXs key management and other personnel, or their failure
to perform
30
their current positions could have a material adverse effect on
EPIXs business, financial condition and results of
operations, and its ability to achieve its business objectives
or to operate or compete in its industry may be seriously
impaired. Competition for personnel is intense and EPIX may not
be successful in attracting or retaining such personnel. If EPIX
were to lose these employees to its competition, it could spend
a significant amount of time and resources to replace them,
which would impair its research and development or
commercialization efforts. If the merger is not consummated,
EPIX must compete with companies that have greater resources
and/or superior product candidates or products to rebuild its
senior management team and attract other personnel.
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EPIX currently depends on its strategic collaborators for
support in product development and the regulatory approval
process and, in the future, will depend on them for product
marketing support as well. These efforts could be materially
harmed if EPIX experiences problems with its
collaborators. |
EPIX depends on strategic collaborators for support in product
development and the regulatory approval process as well as a
variety of other activities including manufacturing, marketing
and distribution of its product candidate in the United States
and abroad, when, and if, the FDA and corresponding foreign
agencies approve its product candidates for marketing. To date,
EPIX has entered into strategic alliances and collaborations
with Schering AG, Tyco/ Mallinckrodt, GE Healthcare, Philips
Medical Systems and Siemens Medical Systems. Four of EPIXs
key agreements include three collaboration agreements with
Schering AG to perform joint research and to develop and
commercialize Vasovist, EP-2104R and other MRI vascular agents
worldwide, and an agreement with Tyco/ Mallinckrodt granting
Tyco/ Mallinckrodt rights to enter into an agreement with
Schering AG to manufacture Vasovist for clinical development and
commercial use. EPIX may not receive milestone payments from
these alliances should Vasovist or
EP-2104R fail to meet
certain performance targets in development and
commercialization. Further, EPIXs receipt of revenues from
strategic alliances is affected by the level of efforts of its
collaborators. EPIXs collaborators may not devote the
resources necessary to complete development and commence
marketing of Vasovist, EP-2104R or other product candidates in
their respective territories, or they may not successfully
market Vasovist, EP-2104R or other product candidates. In
addition, Schering AG and Tyco/ Mallinckrodt currently
manufacture imaging agents for other technologies that will
compete against Vasovist, and Schering AG will be responsible
for setting the price of the product candidate worldwide.
Accordingly, Schering AG may not set prices in a manner that
maximizes revenues for EPIX. EPIXs failure to receive
future milestone payments, or a reduction or discontinuance of
efforts by its partners would have a material adverse effect on
EPIXs business, financial condition and results of
operations.
Furthermore, EPIXs collaboration agreement with Schering
AG may be terminated early under certain circumstances,
including if there is a material breach of the agreement by
either party. In October 2005, EPIX announced that it had
entered into an amendment to its research collaboration
agreement with Schering AG. This amendment narrowed the
definition of the field of collaboration. This research
collaboration expires in May 2006, and EPIX believes that it is
unlikely that the parties will extend the term of the
collaboration. EPIX expects to discuss the disposition of
current research programs with Schering AG prior to expiration
of the collaboration and to continue to advance at least some of
these programs either unilaterally or with another partner.
While the research agreement is separate from EPIXs
agreement with Schering AG relating to Vasovist and EP-2104R,
EPIX cannot predict how the disposition or winding down of the
individual research programs will occur, or whether it will be
able to take forward any of these research programs itself or
find alternative partners for these programs.
In addition, EPIX intends to seek additional collaborations with
third parties who may negotiate provisions that allow them to
terminate their agreements with EPIX prior to the expiration of
the negotiated term under certain circumstances. EPIX is
substantially dependent upon Schering AG to commercialize
Vasovist, EPIXs lead product candidate, in the United
states and Europe. If Schering AG or any other third-party
collaborator were to terminate its agreements with EPIX, if EPIX
is unable to negotiate an acceptable agreement with Schering AG
relating to a new research agreement or if Schering AG or any
other third-party collaborator otherwise fail to perform its
obligations under EPIXs
31
collaboration or to complete them in a timely manner, EPIX could
lose significant revenue. If EPIX is unable to enter into future
strategic alliances with capable partners on commercially
reasonable terms, it may delay the development and
commercialization of future product candidates and could
possibly postpone them indefinitely.
In addition, Bayer AG recently extended an offer to acquire all
of the outstanding shares of Schering AG. Although EPIX has not
yet determined the impact this acquisition may have on its
relationship with Schering AG or the marketing of Vasovist, if
the strategy of Bayer AG and Schering AG after the acquisition
differs from that of Schering AGs current strategy with
respect to the marketing of Vasovist, EPIXs expectations
regarding the marketing of Vasovist could be negatively impacted
which could have a material adverse effect on EPIXs
business.
In addition, EPIX relies on certain of its collaborators, such
as GE Healthcare, Siemens Medical Systems and Philips Medical
Systems, to develop software that can be used to enhance or
suppress veins or arteries from Vasovist-enhanced MRA images.
Although not required for clinical use of Vasovist, the ability
to separate veins from arteries using Vasovist-enhanced MRA may
be useful to clinicians in reading Vasovist-enhanced images for
the evaluation of vascular disease. Therefore, if EPIXs
collaborators do not develop or implement the required software
successfully, some clinicians may not be able to easily
interpret the information provided from Vasovist-enhanced images
and may not be inclined to use the product candidate.
EPIXs inability to market Vasovist successfully to
clinicians would have a material adverse effect on EPIXs
business.
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EPIXs stock price is volatile. It is possible that
you may lose all or part of your investment. |
The market prices of the capital stock of medical technology
companies have historically been very volatile and the market
price of the shares of EPIXs common stock fluctuates. The
market price of EPIXs common stock is affected by numerous
factors, including:
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actual or anticipated fluctuations in EPIXs operating
results; |
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announcements of technological innovation or new commercial
products by EPIX or its competitors; |
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new collaborations entered into by EPIX or its competitors; |
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developments with respect to proprietary rights, including
patent and litigation matters; |
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results of pre-clinical studies and clinical trials; |
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the timing of EPIXs achievement of regulatory milestones; |
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conditions and trends in the pharmaceutical and other technology
industries; |
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adoption of new accounting standards affecting such industries; |
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changes in financial estimates by securities analysts; |
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perceptions of the value of corporate transactions; and |
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degree of trading liquidity in EPIXs common stock and
general market conditions. |
During the year ended December 31, 2005, the closing price
of EPIXs common stock ranged from $17.39 to $3.79. The
last reported closing price for EPIXs common stock on
March 31, 2006, the last trading day before the public
announcement of the merger, was $3.50. Significant declines in
the price of EPIXs common stock could impede EPIXs
ability to obtain additional capital, attract and retain
qualified employees and reduce the liquidity of its common stock.
In addition, the stock market has from time to time experienced
significant price and volume fluctuations that have particularly
affected the market prices for the common stock of similarly
staged companies. These broad market fluctuations may adversely
affect the market price of EPIXs common stock. In the
past, following periods of volatility in the market price of a
particular companys securities,
32
shareholders have often brought class action securities
litigation against that company. Such litigation could result in
substantial costs and a diversion of managements attention
and resources. For example, in January 2005, a securities class
action was filed in U.S. District Court for the District of
Massachusetts against EPIX and certain of its officers on behalf
of persons who purchased EPIXs common stock between
July 10, 2003 and January 14, 2005. The complaint
alleged that EPIX and the other defendants violated the
Securities Exchange Act of 1934, as amended, by issuing a series
of materially false and misleading statements to the market
throughout the class period, which statements had the effect of
artificially inflating the market price of EPIXs
securities. In January 2006, the U.S. District Court for
the District of Massachusetts granted EPIXs Motion to
Dismiss for Failure to Prosecute the shareholder class action
lawsuit against EPIX. The dismissal was issued without prejudice
after a hearing, which dismissal does not prevent another suit
to be brought based on the same claims.
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EPIX has never generated revenues from commercial sales of
its product candidates. |
EPIX currently has one product for sale in Europe and it cannot
guarantee that it will ever have additional marketable product
candidates. Vasovist was approved for commercial sale in Europe
in October 2005 and is currently being marketed in the
Netherlands by EPIXs partner, Schering AG. If Schering AG
fails to launch Vasovist in other countries in the timeframes
EPIX anticipates or fails to achieve the sales EPIX anticipates,
EPIXs revenues could be materially harmed and EPIX may
receive even less royalty income than it currently expects to
receive. EPIX expects to receive a typical pharmaceutical
royalty based on the sale of Vasovist by Schering AG in Europe.
Even if Schering AG continues its launch of Vasovist and it is
able to successfully market and sell Vasovist throughout Europe,
EPIX does not expect any significant royalties for 2006 sales.
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EPIX has never generated positive cash flow, and if EPIX
fails to generate revenue, it will have a material adverse
effect on its business. |
To date, EPIX has received revenues from payments made under
licensing, royalty arrangements and product development and
marketing agreements with strategic collaborators. In
particular, EPIXs revenue for the year ended
December 31, 2005 was $7.2 million and consisted of
$4.2 million from the product development portion of
EPIXs collaboration agreements with Schering AG for
Vasovist, EP-2104R and MRI research; $2.3 million from the
royalty agreements with Bracco and Schering AG and $661,000 of
license fee revenue related to the strategic collaboration
agreements for the development, manufacturing and marketing of
Vasovist with Schering AG and Tyco/ Mallinckrodt and patent
licensing with Bracco. In addition to these sources of revenue,
EPIX has financed its operations to date through public stock
and debt offerings, private sales of equity securities and
equipment lease financings.
Although EPIX believes that it is currently in compliance with
the terms of its collaboration and licensing agreements, the
revenues derived from them are subject to fluctuation in timing
and amount. EPIX may not receive anticipated revenue under its
existing collaboration or licensing agreements, these agreements
may be subject to disputes and, additionally, these agreements
may be terminated upon certain circumstances. Therefore, to
achieve profitable and sustainable operations, EPIX, alone or
with others, must successfully develop, obtain regulatory
approval for, introduce, market and sell products. EPIX may not
receive revenue from the sale of any of its product candidates
for the next several years because it, and its partners, may not:
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successfully complete EPIXs product development efforts; |
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obtain required regulatory approvals in a timely manner, if at
all; |
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manufacture EPIXs product candidates at an acceptable cost
and with acceptable quality; or |
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successfully market any approved products. |
As a result, EPIX may never generate revenues from sales of its
product candidates and its failure to generate positive cash
flow could cause its business to fail.
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EPIX anticipates future losses and may never become
profitable. |
EPIXs future financial results are uncertain. EPIX has
experienced significant losses since it commenced operations in
1992. EPIXs accumulated net losses as of December 31,
2005 were approximately $179.6 million. These losses have
primarily resulted from expenses associated with EPIXs
research and development activities, including pre-clinical
studies and clinical trials, and general and administrative
expenses. EPIX anticipates that its research and development
expenses will remain significant in the future and it expects to
incur losses over at least the next several years as it
continues its research and development efforts, pre-clinical
testing and clinical trials and as it implements manufacturing,
marketing and sales programs. In particular, EPIX may be
required to conduct additional clinical trials in order to
achieve FDA approval of Vasovist, which trials would be
expensive and which could contribute to EPIX continuing to incur
losses. As a result, EPIX cannot predict when it will become
profitable, if at all, and if it does, it may not remain
profitable for any substantial period of time. EPIXs
expenses after the merger may increase significantly as a result
of the addition of Predixs research and development and
commercialization efforts. The merger may also result in losses
to be sustained over a longer period of time than EPIX would
experience on its own without the acquisition of Predix. If EPIX
fails to achieve profitability within the timeframe expected by
investors or if the acquisition of Predix and its research and
development programs negatively impacts EPIXs results of
operations, the market price of its common stock may decline and
consequently its business may not be sustainable.
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If the market does not accept EPIXs technology and
product candidates, EPIX may not generate sufficient revenues to
achieve or maintain profitability. |
The commercial success of Vasovist and EPIXs other product
candidates, even if approved for marketing by the FDA and
corresponding foreign agencies, depends on their acceptance by
the medical community and third-party payors as clinically
useful, cost-effective and safe. While contrast agents are
currently used in an estimated 25% to 35% of all MRI exams,
there are no MRI agents approved by the FDA for vascular
imaging. Furthermore, clinical use of MRA has been limited and
use of MRA for some vascular disease imaging has occurred mainly
in research and academic centers. Market acceptance, and thus
sales of EPIXs products, will depend on several factors,
including:
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safety; |
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cost-effectiveness relative to alternative vascular imaging
methods; |
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availability of third-party reimbursement; |
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ease of administration; |
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clinical efficacy; and |
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availability of competitive products. |
Market acceptance will also depend on EPIXs ability and
that of its strategic partners to educate the medical community
and third-party payors about the benefits of diagnostic imaging
with Vasovist-enhanced MRA compared to imaging with other
technologies. Vasovist represents a new approach to imaging the
non-coronary vascular system, and market acceptance both of MRA
as an appropriate imaging technique for the non-coronary
vascular system, and of Vasovist, is critical to EPIXs
success. If Vasovist or any of EPIXs other product
candidates, when and if commercialized, do not achieve market
acceptance, EPIX may not generate sufficient revenues to achieve
or maintain profitability.
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EPIX may need to raise additional funds necessary to fund
its operations, and if EPIX does not do so, it may not be able
to implement its business plan. |
Since inception, EPIX has funded its operations primarily
through its public offerings of common stock, private sales of
equity securities, debt financing, equipment lease financings,
product development revenue, and royalty and license payments
from its strategic partners. Although EPIX believes that it has
adequate funding for the foreseeable future, it may need to
raise substantial additional funds for research,
34
development and other expenses through equity or debt
financings, strategic alliances or otherwise. EPIXs future
liquidity and capital requirements will depend upon numerous
factors, including the following:
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the progress and scope of clinical trials; |
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the timing and costs of filing future regulatory submissions; |
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the timing and costs required to receive both U.S. and foreign
governmental approvals; |
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the cost of filing, prosecuting, defending and enforcing patent
claims and other intellectual property rights; |
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the extent to which EPIXs product candidates gain market
acceptance; |
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the timing and costs of product introductions; |
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the extent of EPIXs ongoing and any new research and
development programs; |
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the costs of training physicians to become proficient with the
use of EPIXs product candidates; and |
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the costs of developing marketing and distribution capabilities. |
Based on EPIXs current plans, expense rates, targeted
timelines and its view regarding acceptance of Vasovist in the
marketplace, EPIX estimates that cash, cash equivalents and
marketable securities on hand as of December 31, 2005 will
be sufficient to fund its operations for at least the next
several years. However, EPIX premises this expectation on its
current operating plan, which may change as a result of many
factors, including the acquisition of Predix. Taking into
consideration the acquisition of Predix and incorporating its
research and development programs into the operations of EPIX,
EPIX estimates that cash, cash equivalents and marketable
securities on hand as of April 24, 2006, together with
expected revenue from the sale of Vasovist and reimbursement of
clinical trial costs by Schering AG, and the cash, cash
equivalents and marketable securities acquired from Predix, will
fund the combined companys operations into 2008. If,
however, EPIX considers other opportunities, changes its planned
activities or is required to pay all or a substantial portion of
the milestone payment in cash under the merger agreement, it may
require additional funding before currently expected.
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EPIXs competitors may have greater financial
resources, superior products or product candidates,
manufacturing capabilities and/or marketing expertise, and EPIX
may not be able to compete with them successfully. |
The healthcare industry is characterized by extensive research
efforts and rapid technological change and there are several
companies that are working to develop products similar to
EPIXs product candidates. However, there are a number of
general use MRI agents approved for marketing in the United
States. and in certain foreign markets that, if used or
developed for MRA, are likely to compete with Vasovist. Such
products include Magnevist and Gadovist by Schering AG, Dotarem
by Guerbet, S.A., Omniscan by GE Healthcare, ProHance and
MultiHance by Bracco and OptiMARK by Tyco/ Mallinckrodt. EPIX is
aware of five agents under clinical development that have been
or are being evaluated for use in MRA: Schering AGs
Gadomer and SHU555C, Guerbets Vistarem, Braccos
B-22956/1, Ferropharms Code VSOP-C184, and Advanced
Magnetics Ferumoxytol. EPIX cannot assure you that its
competitors will not succeed in the future in developing
products that are more effective than any that EPIX is
developing. EPIX believes that its ability to compete in
developing MRI contrast agents depends on a number of factors,
including the success and timeliness with which it completes FDA
trials, the breadth of applications, if any, for which its
product candidates receive approval, and the effectiveness,
cost, safety and ease of use of its product candidates in
comparison to the products of its competitors. Public
information on the status of clinical development and
performance characteristics for these agents is limited.
However, many of these competitors have substantially greater
capital and other resources than EPIX does and may represent
significant competition for EPIX. These companies may succeed in
developing technologies and products that are more effective or
less costly than any of those that EPIX
35
may develop. In addition, these companies may be more successful
than EPIX is in developing, manufacturing and marketing their
products.
Moreover, there are several well-established medical imaging
methods that currently compete and will continue to compete with
MRI, including digital subtraction angiography, or DSA, which is
an improved form of X-ray angiography, computed tomography
angiography, or CTA, nuclear medicine and ultrasound, and there
are companies that are actively developing the capabilities of
these competing methods to enhance their effectiveness in
vascular system imaging.
EPIX cannot guarantee that it will be able to compete
successfully in the future, or that developments by others will
not render Vasovist or its future product candidates obsolete or
non-competitive, or that its collaborators or customers will not
choose to use competing technologies or products. Any inability
to compete successfully on EPIXs part will have a
materially adverse impact on its operating results.
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Product liability claims could increase EPIXs costs
and adversely affect its results of operations. |
The clinical testing of EPIXs approved products and the
manufacturing and marketing of any approved products may expose
EPIX to product liability claims and it may experience material
product liability losses in the future. EPIX currently has
limited product liability insurance for the use of its product
candidates in clinical research, but its coverage may not
continue to be available on terms acceptable to it or adequate
for liabilities EPIX actually incur. EPIX does not have product
liability insurance coverage for the commercial sale of its
product candidates, but intends to obtain such coverage when and
if EPIX commercializes its product candidates. However, EPIX may
not be able to obtain adequate additional product liability
insurance coverage on acceptable terms, if at all. A successful
claim brought against EPIX in excess of available insurance
coverage, or any claim or product recall that results in
significant adverse publicity against EPIX, may have a material
adverse effect on EPIXs business and results of operations.
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EPIX significantly increased its leverage as a result of
the sale of 3.0% Convertible Senior Notes due 2024. |
In connection with the sale of 3.0% Convertible Senior
Notes due 2024, EPIX has incurred indebtedness of
$100 million. In addition, holders of EPIXs 3%
Convertible Senior Notes due 2024 may require EPIX to repurchase
these notes at par, plus accrued and unpaid interest, on
June 15, 2011, 2014 and 2019. The amount of EPIXs
indebtedness could, among other things:
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make it difficult for EPIX to make payments on the notes; |
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make it difficult for EPIX to obtain financing for working
capital, acquisitions or other purposes on favorable terms, if
at all; |
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make EPIX more vulnerable to industry downturns and competitive
pressures; and |
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limit EPIXs flexibility in planning for, or reacting to
changes in, its business. |
EPIXs ability to meet its debt service obligations will
depend upon its future performance, which will be subject to
regulatory approvals and sales of its products, as well as other
financial and business factors affecting its operations, many of
which are beyond EPIXs control.
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Certain anti-takeover clauses in EPIXs charter and
by-laws and in Delaware law may make an acquisition of EPIX more
difficult. |
EPIXs restated certificate of incorporation authorizes the
EPIX board of directors to issue, without stockholder approval,
up to 1,000,000 shares of preferred stock with voting,
conversion and other rights and preferences that could adversely
affect the voting power or other rights of the holders of
EPIXs common stock. The issuance of preferred stock or of
rights to purchase preferred stock could be used to discourage
an unsolicited acquisition proposal. In addition, the possible
issuance of preferred stock could discourage a
36
proxy contest, make more difficult the acquisition of a
substantial block of EPIXs common stock or limit the price
that investors might be willing to pay for shares of EPIXs
common stock. The restated certificate of incorporation provides
for staggered terms for the members of the EPIX board of
directors. A staggered EPIX board of directors and certain
provisions of EPIXs by-laws and of the state of Delaware
law applicable to EPIX could delay or make more difficult a
merger, tender offer or proxy contest involving EPIX. EPIX is
subject to Section 203 of the General Corporation Law of
Delaware, which, subject to certain exceptions, restricts
certain transactions and business combinations between a
corporation and a stockholder owning 15% or more of the
corporations outstanding voting stock for a period of
three years from the date the stockholder becomes an interested
stockholder. These provisions may have the effect of delaying or
preventing a change in control of EPIX without action by the
stockholders and, therefore, could adversely affect the price of
EPIXs stock.
Risks Relating to the Business of Predix and the Combined
Company
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If Predix does not obtain required regulatory approval of
its drug candidates, Predix will be unable to market and sell
Predixs drug candidates. |
PRX-00023, PRX-03140 and PRX-08066 and any other drug candidates
Predix may discover or acquire and seek to commercialize are
subject to extensive regulation by the FDA and similar
regulatory agencies in other countries relating to development,
clinical trials, manufacturing and commercialization. In the
United States and in many foreign jurisdictions, rigorous
pre-clinical testing and clinical trials and an extensive
regulatory review process must be successfully completed before
a new drug can be sold. Satisfaction of these and other
regulatory requirements is costly, time consuming, uncertain and
subject to unanticipated delays. The time required to obtain
approval by the FDA is unpredictable but typically exceeds five
years following the commencement of clinical trials, depending
upon many factors, including the complexity of the drug
candidate. Predix initiated clinical trials for PRX-00023,
PRX-03140 and PRX-08066 in February 2004, December 2004 and May
2005, respectively, and thus far, these drug candidates have
been studied in only a small number of patients. Early-stage
clinical trials in small numbers of patients are often not
predictive of results in later-stage clinical trials with a
larger and more diverse patient population. Even drug candidates
with favorable results in late-stage pivotal clinical trials may
fail to get approved for commercialization for many reasons,
including:
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Predixs failure to demonstrate to the satisfaction of the
FDA or comparable foreign regulatory authorities that a drug
candidate is safe and effective for a particular indication; |
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Predixs inability to demonstrate that a drug
candidates benefits outweigh its risks; |
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Predixs inability to demonstrate that the drug candidate
presents a significant advantage over existing therapies; |
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the FDAs or comparable foreign regulatory
authorities disagreement with the manner in which Predix
and Predixs collaborators interpret the data from
pre-clinical studies or clinical trials; |
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the FDAs or comparable foreign regulatory
authorities failure to approve Predixs manufacturing
processes or facilities or the processes or facilities of
Predixs collaborators; or |
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a change in the approval policies or regulations of the FDA or
comparable foreign regulatory authorities. |
It is possible that none of Predixs drug candidates or any
other drug candidates Predix may seek to develop in the future
will ever obtain the appropriate regulatory approvals necessary
for Predix to begin selling them.
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Predixs clinical trials may not yield results that
will enable Predix to obtain regulatory approval for
Predixs drug candidates. |
Predix will only receive regulatory approval to commercialize a
drug candidate if Predix can demonstrate to the satisfaction of
the FDA or the applicable foreign regulatory agency, in
well-designed and conducted clinical trials, that the drug
candidate is safe and effective and otherwise meets the
appropriate standards required for approval for a particular
indication. Clinical trials are lengthy, complex and extremely
expensive processes with uncertain results. Predix has limited
experience in conducting and managing the clinical trials
necessary to obtain regulatory approvals, including approval by
the FDA. In connection with the clinical trials for PRX-00023,
PRX-03140 and PRX-08066 and any other drug candidate Predix may
seek to develop in the future, Predix faces risks including that:
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the drug candidate may not prove to be safe and efficacious; |
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the dosage form of the drug candidate may not deliver
reproducible amounts of drug to patients; |
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patients may die or suffer other adverse effects for reasons
that may or may not be related to the drug candidate being
tested; |
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the results of later-stage clinical trials may not confirm the
positive results of earlier trials; |
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the results may not meet the level of statistical significance
required by the FDA or other regulatory agencies for
approval; and |
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the FDA or other regulatory agencies may require additional or
expanded trials. |
Of the large number of drugs in development, only a small
percentage result in the submission of an NDA to the FDA and
even fewer are approved for commercialization. If Predix fails
to demonstrate the safety and efficacy of Predixs drug
candidates, Predix will not be able to obtain the required
regulatory approvals to commercialize these drug candidates.
Furthermore, even if Predix does receive regulatory approval to
market a commercial product, any such approval may be subject to
limitations on the indicated uses for which Predix or a
collaborator may market the product.
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Because all of Predixs drug candidates are in early
stages of development, there is a high risk of failure, and
Predix may never succeed in developing marketable products or
generating product revenue. |
Predix has no drug candidates that have received regulatory
approval for commercial sale. Predixs most advanced drug
candidate, PRX-00023, completed a Phase IIa clinical trial
in July 2005, and Predix is expecting to complete the first of
at least two pivotal Phase III clinical trials for
generalized anxiety disorder, or GAD, for this drug candidate in
the second half of 2006. Predix has two other clinical-stage
drug candidates: PRX-03140 for the treatment of Alzheimers
disease that is expected to enter Phase II clinical trials
in the second half of 2006, and
PRX-08066 for the
treatment of two types of pulmonary hypertension, or PH, which
are PH associated with chronic obstructive pulmonary disease, or
COPD, that is expected to enter Phase II clinical trials in
the second half of 2006, and pulmonary arterial hypertension, or
PAH. In addition, PRX-08066 has never been tested in patients
with PAH or PH associated with COPD. Predix does not expect to
have any commercial products on the market for at least the next
several years, if at all. Predix is exploring human diseases at
the cellular level and attempting to develop drug candidates
that regulate cellular processes. Trial and error is inherent in
drug discovery and development, and Predix may fail at numerous
stages along the way. Success in pre-clinical studies of a drug
candidate may not be predictive of similar results in humans
during clinical trials, and successful results from early
clinical trials of a drug candidate may not be replicated in
later clinical trials. A number of companies in the
pharmaceutical and biotechnology industries have suffered
significant setbacks in late-stage clinical trials even after
achieving promising results in early-stage development. For
example, Sanofi-Aventis recently discontinued the development of
its 5-HT4 candidate for the treatment of Alzheimers
disease due to lack of efficacy. This compound is believed to
have the same mechanism of action as PRX-03140, was more
advanced in the clinic and was more potent in in vitro
assays. Accordingly, the results
38
from the completed and ongoing studies and trials for PRX-00023,
PRX-03140 and PRX-08066 may not be predictive of the results
Predix may obtain in later-stage trials.
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If clinical trials for Predixs drug candidates,
including PRX-00023, PRX-03140 and PRX-08066, are prolonged or
delayed, Predix may be unable to commercialize Predixs
drug candidates on a timely basis, which would require Predix to
incur additional costs and delay Predixs receipt of any
revenue from potential product sales. |
Predix may encounter problems with Predixs completed,
ongoing or planned clinical trials that will cause Predix or any
regulatory authority to delay or suspend those clinical trials
or delay the analysis of data derived from them. A number of
events, including any of the following, could delay the
completion of Predixs ongoing and planned clinical trials
and negatively impact Predixs ability to obtain regulatory
approval for, and to enter into collaborations, market and/or
sell, a particular drug candidate, including Predixs
clinical-stage drug candidates PRX-00023, PRX-03140 and
PRX-08066:
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conditions imposed on Predix by the FDA or any foreign
regulatory authority regarding the scope or design of
Predixs clinical trials; |
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delays in obtaining, or Predixs inability to obtain,
required approvals from institutional review boards or other
reviewing entities at clinical sites selected for participation
in Predixs clinical trials; |
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delay in developing a clinical dosage form, insufficient supply
or deficient quality of Predixs drug candidates or other
materials necessary to conduct Predixs clinical trials; |
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negative or inconclusive results from clinical trials, or
results that are inconsistent with earlier results, that
necessitate additional clinical study; |
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negative or inconclusive results from clinical trials, or
results that are inconsistent with earlier results, that
necessitate additional clinical study; |
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serious and/or unexpected drug-related side effects experienced
by subjects in clinical trials; or |
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failure of Predixs third-party contractors or
Predixs investigators to comply with regulatory
requirements or otherwise meet their contractual obligations to
Predix in a timely manner. |
In addition, the number and complexity of clinical trials needed
to achieve regulatory approval for
PRX-00023 for the
treatment of GAD and depression, and
PRX-03140 for the
treatment of Alzheimers disease, could be significant.
Achieving primary efficacy endpoints in these trials is
difficult due to the significant placebo effect in these patient
populations. In addition, the clinical path of PRX-00023 may be
delayed because Predix has less clinical data and clinical
experience with
PRX-00023 than it would
have had it followed the more common practice of conducting more
than one Phase II clinical trial for
PRX-00023. Instead,
after meeting with the FDA regarding the design, endpoints and
statistical plan of its Phase III clinical trial, Predix
elected to progress
PRX-00023 directly into
Phase III development. In addition, Predix must also submit
the results of a two-year carcinogenicity study of
PRX-00023 prior to its
approval. Predix has not yet initiated this study and intends to
conduct this study prior to submitting an NDA to the FDA. If the
clinical development of PRX-00023 is delayed as a result of
these matters, additional requirements set forth by the FDA,
including requirements related to confirming the correct dose
for PRX-00023, or
otherwise, the time and cost of the development of PRX-00023
could increase significantly.
Predixs clinical trials may not begin as planned, may need
to be restructured, and may not be completed on schedule, if at
all. Delays in Predixs clinical trials may result in
increased development costs for Predixs drug candidates.
In addition, if Predixs clinical trials are delayed,
Predixs competitors may be able to bring product
candidates to market before Predix does and the commercial
viability of Predixs drug candidates, including PRX-00023,
PRX-03140 and PRX-08066, could be significantly reduced.
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If Predix encounters difficulties enrolling subjects in
Predixs clinical trials, or subjects drop out of trials in
progress, Predixs trials could be delayed or otherwise
adversely affected. |
Clinical trials for Predixs drug candidates require
sufficient patient enrollment. Predix may not be able to enroll
a sufficient number of qualified patients in a timely or
cost-effective manner. For example, Predix experienced
difficulty in enrolling healthy elderly volunteers in
Predixs Phase I clinical trial for PRX-03140. Any
future delays in patient enrollment could result in increased
costs and longer development times. Enrollment of patients is
affected by many factors, including:
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the limited size of the patient population and the availability
of commercial products for certain target indications, including
PAH and PH associated with COPD; |
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the nature and design of the trial protocol; |
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the proximity of patients to clinical sites; |
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the availability of other effective treatments for the relevant
disease (whether approved or experimental); |
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the eligibility criteria for enrollment in Predixs
clinical trials; |
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perceived risks and benefits of the drug candidate under
study; and |
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competing studies or trials. |
Predixs failure to enroll patients in Predixs
clinical trials could delay the completion of these clinical
trials. Furthermore, enrolled patients may drop out of
Predixs clinical trials, which could impair the validity
or statistical significance of the clinical trials. In addition,
the FDA could require Predix to conduct clinical trials with a
larger number of subjects than Predix has projected for any of
Predixs drug candidates. If Predix has difficulty
enrolling or retaining a sufficient number of patients to
participate and complete Predixs clinical trials as
planned, Predix may need to delay or terminate ongoing or
planned clinical trials. Delays in enrolling patients in
Predixs clinical trials or the withdrawal of subjects
enrolled in Predixs clinical trials would adversely affect
Predixs ability to develop and seek approval for
Predixs drug candidates, could delay or eliminate
Predixs ability to generate drug candidates and revenue
and could impose significant additional costs on Predix.
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Predixs drug candidates are currently
unformulated. |
All of Predixs drug candidates, including its lead product
candidate, PRX-00023, are currently unformulated. The lack of an
optimized and commercially-viable formulation during clinical
trials may have a significant impact in the overall development
and commercialization of these drug candidates, including:
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the current dosage may not provide reproducible amounts of drug; |
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the pharmaceutical development of a commercially viable
formulation may add significant cost and time to Predixs
clinical development programs; |
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additional trials may be required if the new formulation is not
bioequivalent to formulations already used in clinical trials; |
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future clinical trials may be delayed in order to identify,
develop, optimize, manufacture and certify a commercially viable
formulation; and |
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regulatory filings, and/or commercial launch may be delayed due
to the lack of a commercial process for cGMP manufacturing of
the new formulation. |
The occurrence of any of the foregoing could materially harm
Predixs business.
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If Predix fails to obtain the additional capital necessary
to fund Predixs operations, Predix will be unable to
successfully develop and commercialize Predixs drug
candidates. |
Predix will require substantial future capital in order to
continue to complete clinical development and commercialize
Predixs clinical-stage drug candidates, PRX-00023,
PRX-03140 and PRX-08066, and to conduct the research and
development and clinical and regulatory activities necessary to
bring other drug candidates to market. Predixs future
capital requirements will depend on many factors that are
currently unknown to us, including:
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the progress and results of Predixs first Phase III
clinical trial for PRX-00023 and any other trials Predix may
initiate based on the results of this trial; |
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Predixs ability to enter into a strategic collaboration,
licensing or other arrangement, particularly with respect to
PRX-00023, on terms favorable to Predix; |
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the progress and results of any future clinical trials Predix
may initiate with PRX-03140 and
PRX-08066 based on the
Phase I results obtained to date; |
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the results of Predixs pre-clinical studies and testing
for Predixs pre-clinical programs, and any decisions to
initiate clinical trials if supported by the pre-clinical
results; |
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the costs, timing and outcome of regulatory review of PRX-00023,
PRX-03140 and PRX-08066, and any pre-clinical drug candidates
that progress to clinical trials; |
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the scope, progress, results and cost of pre-clinical
development, manufacturing, pharmaceutical development, clinical
trials and regulatory review of any new drug candidates Predix
may discover or acquire; |
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the costs of preparing, filing and prosecuting patent
applications, maintaining and enforcing Predixs issued
patents, and defending intellectual property-related claims; |
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the costs of establishing sales and marketing functions and of
establishing commercial manufacturing arrangements if any of
Predixs drug candidates is approved; |
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the costs to satisfy Predixs obligations under potential
future collaborations; and |
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the timing, receipt and amount of sales or royalties, if any,
from PRX-00023, PRX-03140 and
PRX-08066, and any
other drug candidates. |
Predix cannot assure you that additional funds will be available
when Predix needs them on terms that are acceptable to Predix,
or at all. Companies at Predixs stage of development have
recently encountered difficulties raising money under current
conditions in the capital markets. For example, Predix
commenced, but did not successfully complete, an initial public
offering of its common stock in 2005. If adequate funds are not
available on a timely basis, Predix may be required to:
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terminate or delay pre-clinical studies, manufacturing,
pharmaceutical development, clinical trials or other development
for one or more of Predixs drug candidates, including the
initiation of clinical development of PRX-00023 for a depression
indication; |
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delay Predixs establishment of sales and marketing
capabilities or other activities that may be necessary to
commercialize any of Predixs drug candidates; or |
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curtail significant drug discovery programs that are designed to
identify new drug candidates. |
Based on Predixs current plans, expense rates, targeted
timelines and its view regarding the progression of its product
candidates through clinical trials, Predix estimates that cash,
cash equivalents and marketable securities on hand as of
April 4, 2006 will be sufficient to fund its operations
through July 2006. As a result, there exists substantial doubt
about Predixs ability to continue as a going concern
through December 31, 2006 without additional funding or the
successful completion of the merger. However, Predix premises
this expectation on its current operating plan, which may change
as a result of many factors including its acquisition by EPIX
and the access to EPIXs cash, cash equivalents and
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marketable securities if the merger is completed. However,
Predix may need additional funds sooner than planned. In
addition, Predix may seek additional capital if market
conditions permit or for strategic considerations even if Predix
believes Predix has sufficient funds for Predixs current
or future operating plans.
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Failure to comply with foreign regulatory requirements
governing human clinical trials and marketing approval for drugs
could prevent Predix from selling Predixs drug candidates
in foreign markets, which may adversely affect Predixs
operating results and financial condition. |
The requirements governing the conduct of clinical trials,
product licensing, pricing and reimbursement for marketing
Predixs drug candidates outside the United States vary
greatly from country to country and may require additional
testing. Predix has no experience in obtaining foreign
regulatory approvals. The time required to obtain approvals
outside the United States may differ from that required to
obtain FDA approval. Predix may not obtain foreign regulatory
approvals on a timely basis, if at all. Approval by the FDA does
not ensure approval by regulatory authorities in other
countries, and approval by one foreign regulatory authority does
not ensure approval by regulatory authorities in other countries
or by the FDA. Failure to comply with these regulatory
requirements or obtain required approvals could impair
Predixs ability to develop foreign markets for
Predixs drug candidates.
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Predixs drug candidates will remain subject to
ongoing regulatory requirements even if they receive marketing
approval, and if Predix fails to comply with requirements,
Predix could lose these approvals and the sale of any approved
commercial products could be temporarily or permanently
suspended. |
Even if Predix receives regulatory approval to market a
particular drug candidate, the product will remain subject to
extensive regulatory requirements, including requirements
relating to manufacturing, labeling, packaging, adverse event
reporting, storage, advertising, promotion and record keeping.
In addition, as clinical experience with a drug expands after
approval because it is typically used by a greater number of
patients after approval than during clinical trials, side
effects and other problems may be observed after approval that
were not seen or anticipated during pre-approval clinical
trials. If Predix fails to comply with the regulatory
requirements of the FDA and other applicable U.S. and foreign
regulatory authorities or previously unknown problems with any
approved commercial products, manufacturers or manufacturing
processes are discovered, Predix could be subject to
administrative or judicially imposed sanctions or other
setbacks, including:
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restrictions on the products, manufacturers or manufacturing
processes; |
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civil or criminal penalties; |
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fines; |
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injunctions; |
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product seizures or detentions; |
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import bans; |
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product recalls and related publicity requirements; |
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total or partial suspension of production; and |
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refusal to approve pending applications for marketing approval
of new products or supplements to approved applications. |
The imposition on Predix of any of the foregoing could
materially harm Predixs business.
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Predix deals with hazardous materials and must comply with
environmental laws and regulations, which can be expensive and
restrict how Predix does business. |
Predixs activities may involve the controlled storage, use
and disposal of a small amount of hazardous materials, including
infectious agents, corrosive, explosive and flammable chemicals
and various radioactive compounds. Predix is subject to federal,
state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of these hazardous
materials. Although Predix believes that Predixs safety
procedures for handling and disposing of these materials comply
with the standards prescribed by these laws and regulations,
Predix cannot eliminate the risk of accidental contamination or
injury from these materials.
In the event of an accident, state or federal authorities may
curtail Predixs use of these materials and interrupt
Predixs business operations. In addition, Predix could be
liable for any civil damages that result, which may exceed
Predixs financial resources and may seriously harm
Predixs business. Due to the small amount of hazardous
materials that Predix generates, Predix has determined that the
cost to secure insurance coverage for environmental liability
and toxic tort claims far exceeds the benefits. Accordingly,
Predix does not maintain any insurance to cover pollution
conditions or other extraordinary or unanticipated events
relating to Predixs use and disposal of hazardous
materials. Additionally, an accident could damage, or force
Predix to shut down, Predixs operations. In addition, if
Predix develops a manufacturing capacity, Predix may incur
substantial costs to comply with environmental regulations and
would be subject to the risk of accidental contamination or
injury from the use of hazardous materials in Predixs
manufacturing process.
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Predix is focusing Predixs drug discovery and
development efforts on GPCR and ion channel-targeted drug
candidates, which have historically had a high incidence of
adverse side effects. |
Despite commercial success, many GPCR and ion channel-targeted
drugs have been associated with a high incidence of adverse side
effects due in part to poor selectivity in binding to their
target protein, resulting in also binding to other
off-target proteins. Predix believes it is designing
its drug candidates to be more selective and to have a more
favorable side-effect profile. However, all of Predixs
drug candidates are in early stages of development, and although
Predixs clinical drug candidates have to date exhibited
acceptable side-effect profiles in clinical trials in a limited
number of subjects, Predix cannot assure you that these results
will be repeated in larger-scale trials. If serious side effects
occur in later-stage clinical trials of Predixs drug
candidates, Predix may not receive regulatory approval to
commercialize them. Even if any of Predixs drug candidates
receive regulatory approval, if they do not exhibit a more
favorable side-effect profile than existing therapies,
Predixs competitive position could be substantially
diminished.
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The application of Predixs in silico drug discovery
technology and approach may be limited to a subset of
therapeutically useful GPCR and ion channel proteins, which may
reduce the opportunities to develop and commercialize drug
candidates against other important therapeutic targets. |
To date, Predixs technology and approach has generated
clinical drug candidates, including
PRX-00023, PRX-03140
and PRX-08066, which mimic the activity of a small molecule,
serotonin, within a class of GPCRs known as serotonergic
receptors. The activity is achieved through binding of the
ligand, serotonin, to a lipophilic region of the transmembrane
spanning domain. These GPCRs and mechanisms of interaction
represent a small subset of all known therapeutically-relevant
GPCRs. The application of Predixs in silico
technology to other known therapeutically-relevant GPCR targets
based on large molecule ligands, hydrophilic interactions or
surface interactions is unknown. Ion channels can consist of
multiple protein subunits that have complex and subtle
mechanisms of activation and inactivation. Therefore, it may be
difficult to apply Predixs proprietary drug discovery
technology to small-molecule ion channel programs. Although
Predix believes that the in silico technology platform
can be utilized and developed to discover such small molecules,
Predix cannot ensure that its in silico technology and
approach will generate clinical candidates for all GPCRs and ion
channels that are important targets for therapeutic intervention.
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Predix may not be able to keep up with the rapid
technological change in the biotechnology and pharmaceutical
industries, which could make any of Predixs future
approved products obsolete and reduce Predixs
revenue. |
Biotechnology and related pharmaceutical technologies have
undergone and continue to be subject to rapid and significant
change. Predixs future will depend in large part on
Predixs ability to maintain a competitive position with
respect to these technologies. Predix believes that its
proprietary drug discovery technology and approach enables
structure-based discovery and optimization of certain GPCR and
ion channel-targeted drug candidates. However, Predixs
competitors may render Predixs technologies obsolete by
advances in existing GPCR and ion channel-targeted drug
discovery approaches or the development of new or different
approaches. In addition, any future products that Predix
develops, including Predixs clinical-stage drug
candidates, PRX-00023, PRX-03140 and PRX-08066, may become
obsolete before Predix recovers expenses incurred in developing
those products, which may require that Predix raise additional
funds to continue Predixs operations.
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Predixs competitors may develop products that are
less expensive, safer or more effective, which may diminish or
eliminate the commercial success of any future products that
Predix may commercialize. |
Competition in the pharmaceutical and biotechnology industries
is intense and expected to increase. Predix faces competition
from pharmaceutical and biotechnology companies, as well as
numerous academic and research institutions and governmental
agencies engaged in drug discovery activities or funding, both
in the United States and abroad. Some of these competitors have
products or are pursuing the development of drug candidates that
target the same diseases and conditions that are the focus of
Predixs clinical-stage product candidates, including the
following:
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PRX-00023. If approved, PRX-00023, the drug candidate
Predix is developing for the treatment of anxiety and
depression, will compete with approved products from such
pharmaceutical companies as Forest Laboratories,
GlaxoSmithKline, Pfizer and Wyeth, and may compete with several
drug candidates in clinical development from other companies,
including Eli Lilly and MediciNova. Predix believes that there
are over 35 drug candidates in clinical trials or that have
been submitted for approval for the treatment of anxiety and
over 45 drug candidates in clinical trials or that have
been submitted for approval for the treatment of depression. |
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PRX-03140. If approved, PRX-03140, the drug candidate
Predix is developing for the treatment of Alzheimers
disease, will compete with approved products from such
pharmaceutical companies as Forest Laboratories,
Johnson & Johnson, Novartis and Pfizer, and may compete
with several drug candidates in clinical development from other
companies, including Myriad Genetics and Neurochem. Predix
believes that there are over 60 drug candidates in clinical
trials for the treatment of Alzheimers disease. |
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PRX-08066. If approved, PRX-08066, the drug candidate
Predix is developing for the treatment of PH, will compete with
approved products from such pharmaceutical companies as
Actelion, CoTherix, GlaxoSmithKline, Pfizer and United
Therapeutics, and may compete with several drug candidates in
clinical development by other companies such as Encysive
Pharmaceuticals and Myogen. Predix believes that there are
approximately ten drug candidates in clinical trials or that
have been submitted for approval for the treatment of PAH and/or
PH associated with COPD. |
Many patents covering commercial products for these indications
will expire within the next four to nine years, which will
result in greater competition in these indications resulting
from companies producing generic versions of the commercial
drugs. In addition, many of Predixs competitors and their
collaborators have substantially greater capital, research and
development resources, manufacturing, sales and marketing
experience and capabilities. Smaller companies also may prove to
be significant competitors, particularly through proprietary
research discoveries and collaboration arrangements with large
pharmaceutical and established biotechnology companies. Many of
Predixs competitors have products that have been approved
or are in advanced development and may develop superior
technologies or methods to identify and validate drug targets
and to discover novel small-molecule drugs. Predixs
competitors, either alone or with their
44
collaborators, may succeed in developing drugs that are more
effective, safer, more affordable or more easily administered
than Predixs and may achieve patent protection or
commercialize drugs sooner than Predix. Predixs
competitors may also develop alternative therapies that could
further limit the market for any drugs that Predix may develop.
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If a successful product liability claim or series of
claims is brought against Predix for uninsured liabilities or in
excess of insured liabilities, Predix could be forced to pay
substantial damage awards. |
The use of any of Predixs drug candidates in clinical
trials, and the sale of any approved products, might expose
Predix to substantial product liability claims. Predix currently
maintains product liability insurance coverage in the amount of
$10 million to cover Predix against such claims. However,
such insurance coverage might not protect Predix against all of
the claims to which Predix might become subject. Predix might
not be able to maintain adequate insurance coverage at a
reasonable cost or in sufficient amounts or scope to protect
Predix against potential losses. If a claim is brought against
Predix, Predix might be required to pay legal and other expenses
to defend the claim, as well as uncovered damages awards
resulting from a claim brought successfully against Predix.
Furthermore, whether or not Predix is ultimately successful in
defending any such claims, Predix might be required to direct
significant financial and managerial resources to such defense
and adverse publicity is likely to result.
Risks Relating to Predixs Dependence on Third
Parties
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Predix relies on third parties to conduct Predixs
clinical trials, and those third-parties may not perform
satisfactorily, including failing to meet established deadlines
for the completion of such trials. |
Predix does not have the ability to independently conduct
clinical trials for Predixs drug candidates, and Predix
relies on third parties such as contract research organizations,
medical institutions and clinical investigators to enroll
qualified patients and conduct Predixs clinical trials.
Predixs reliance on these third parties for clinical
development activities reduces Predixs control over these
activities. Accordingly, these third-party contractors may not
complete activities on schedule, or may not conduct
Predixs clinical trials in accordance with regulatory
requirements or Predixs trial design. To date, Predix
believes Predixs contract research organizations and other
similar entities with which Predix is working have performed
well. However, if these third parties do not successfully carry
out their contractual duties or meet expected deadlines, Predix
may be required to replace them. Although Predix believes that
there are other third-party contractors Predix could engage to
continue these activities, it may result in a delay of the
affected trial. Accordingly, Predixs efforts to obtain
regulatory approvals for and commercialize Predixs drug
candidates may be delayed.
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Predixs drug candidates require significant
biological testing, pre-clinical testing, manufacturing and
pharmaceutical development expertise and investment. Predix
relies primarily on external partners to complete these
activities. |
Predix does not have in-house biological or pre-clinical testing
capabilities. Therefore, it relies on third parties to perform
in vitro potency, in vivo functional
efficacy, animal toxicology and pharmacokinetics testing prior
to advancing its product candidates into clinical trials. Predix
also does not have internal expertise to scale up, manufacture
or formulate its drug candidates. If any of these third parties
fail to fulfill their obligations to Predix or do not
successfully compete the testing in a timely or acceptable
manner, Predixs drug development efforts could be
negatively impacted and/or delayed.
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If Predix does not establish a collaboration to further
develop and commercialize PRX-00023 or other drug candidates,
Predix may have to alter Predixs development plans. |
Predixs drug development programs and potential
commercialization of Predixs drug candidates will require
substantial additional cash to fund expenses. Predixs
strategy includes collaborating with a leading pharmaceutical or
biotechnology company to assist Predix in further developing and
potentially commercializing
PRX-00023 and its other
drug candidates requiring large commercial sales and marketing
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infrastructures. Predix may also seek to enter into such
collaborations for Predixs other drug candidates,
especially for target indications in which the potential
collaborator has particular therapeutic expertise or that
involve a large, primary care market that must be served by
large sales and marketing organizations. Predix faces
significant competition in seeking appropriate collaborators and
these collaborations are complex and time-consuming to negotiate
and document. Although Predix has had discussions with several
prospective collaborative partners with respect to development
programs, Predix does not currently have any agreement or
arrangement with respect to any such collaboration. Predix may
not be able to enter into any such collaboration on terms that
are acceptable to Predix, or at all. If that were to occur,
Predix may have to curtail the development of a particular drug
candidate, reduce or delay its development program or one or
more of Predixs other development programs, delay its
potential commercialization, or increase Predixs
expenditures and undertake development or commercialization
activities at Predixs own expense. If Predix elects to
increase Predixs expenditures to fund development or
commercialization activities on Predixs own, Predix will
need to obtain additional capital, which may not be available to
Predix on acceptable terms, or at all. If Predix does not obtain
sufficient funds, Predix will not be able to complete clinical
development of Predixs drug candidates or bring
Predixs drug candidates to market and generate product
revenue.
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If physicians and patients do not accept Predixs
product candidates, Predix may be unable to generate significant
revenue, if any. |
Even if PRX-00023, PRX-03140 and PRX-08066, or any other drug
candidates Predix may develop or acquire in the future, obtain
regulatory approval, they may not gain market acceptance among
physicians, healthcare payors, patients and the medical
community. Physicians may elect not to recommend these drugs for
a variety of reasons including:
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timing of market introduction of competitive products; |
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lower demonstrated clinical safety and efficacy compared to
other products; |
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lack of cost-effectiveness; |
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lack of availability of reimbursement from managed care plans
and other third-party payors; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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other potential advantages of alternative treatment
methods; and |
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ineffective marketing and distribution support. |
If Predixs approved drugs, if any, fail to achieve market
acceptance, Predix would not be able to generate significant
revenue.
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If the government and third-party payors fail to provide
coverage and adequate payment rates for Predixs product
candidates, if any, Predixs revenue and prospects for
profitability will be harmed. |
In both domestic and foreign markets, Predixs sales of any
product candidates will depend in part upon the availability of
reimbursement from third-party payors. Such third-party payors
include government health programs such as Medicare, managed
care providers, private health insurers and other organizations.
These third-party payors are increasingly attempting to contain
healthcare costs by demanding price discounts or rebates and
limiting both coverage on which drugs they will pay for and the
amounts that they will pay for new drugs. As a result, they may
not cover or provide adequate payment for Predixs drugs.
Predix might need to conduct post-marketing studies in order to
demonstrate the cost-effectiveness of any future products to
such payors satisfaction. Such studies might require
Predix to commit a significant amount of management time and
financial and other resources. Predixs future products
might not ultimately be considered cost-effective. Adequate
third-party reimbursement might not
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be available to enable Predix to maintain price levels
sufficient to realize an appropriate return on investment in
product development.
U.S. and foreign governments continue to propose and pass
legislation designed to reduce the cost of healthcare. For
example, in some foreign markets, the government controls the
pricing of prescription pharmaceuticals. In the United States,
Predix expects that there will continue to be federal and state
proposals to implement similar governmental controls. In
addition, recent changes in the Medicare program and increasing
emphasis on managed care in the United States will continue to
put pressure on pharmaceutical product pricing. Cost control
initiatives could decrease the price that Predix would receive
for any products in the future, which would limit Predixs
revenue and profitability. Accordingly, legislation and
regulations affecting the pricing of pharmaceuticals might
change before Predixs drug candidates are approved for
marketing. Adoption of such legislation could further limit
reimbursement for pharmaceuticals.
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Risks Relating to Predixs Intellectual Property |
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If Predixs patent position does not adequately
protect Predixs drug candidates or any future products,
others could compete against Predix more directly, which would
harm Predixs business. |
As of April 7, 2006, Predixs patent portfolio
included a total of 17 pending patent applications in the United
States as well as counterpart applications in certain foreign
countries having composition of matter, method of use and
process claims related to Predixs programs. PRX-00023 is
the subject of one pending patent application filed in 20
jurisdictions since 2004. PRX-03140 is the subject of three
pending patent applications filed in six jurisdictions since
2004. PRX-08066 is the subject of U.S. Patent 17,030,240,
and two other pending patent applications filed in 21
jurisdictions since 2004. PRX-07034 is the subject of two
pending patent applications filed in two jurisdictions.
Predixs commercial success will depend in part on
Predixs ability to cause patents to issue on these
applications, obtain additional patents and protect
Predixs existing patent position as well as Predixs
ability to maintain adequate protection of other intellectual
property for Predixs technologies, drug candidates and any
future products in the United States and other countries. If
Predix does not adequately protect Predixs intellectual
property, competitors may be able to use Predixs
technologies and erode or negate any competitive advantage
Predix may have, which could harm Predixs business and
ability to achieve profitability. Patents may also issue to
third parties which could interfere with Predixs ability
to bring one or more of Predixs drug candidates to market.
The laws of some foreign countries do not protect Predixs
proprietary rights to the same extent as the laws of the United
States, and Predix may encounter significant problems in
protecting Predixs proprietary rights in these countries.
The patent positions of biotechnology and pharmaceutical
companies, including Predixs patent position, involve
complex legal and factual questions, and, therefore, any patents
issued to Predix may be challenged, deemed unenforceable,
invalidated or circumvented. Predix will be able to protect
Predixs proprietary rights from unauthorized use by third
parties only to the extent that Predixs proprietary
technologies, drug candidates, and any future products are
covered by valid and enforceable patents or are effectively
maintained as trade secrets.
The degree of future protection for Predixs proprietary
rights is uncertain, and Predix cannot ensure that:
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Predix or Predixs licensors were the first to make the
inventions covered by each of Predixs pending patent
applications; |
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Predix or Predixs licensors were the first to file patent
applications for these inventions; |
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others will not independently develop similar or alternative
technologies or duplicate any of Predixs technologies; |
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any of Predixs or Predixs licensors pending
patent applications will result in issued patents; |
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any of Predixs or Predixs licensors patents
will be valid or enforceable; |
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any patents issued to Predix or Predixs licensors and
collaborators will provide a basis for commercially viable
products, will provide Predix with any competitive advantages or
will not be challenged by third parties; |
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Predix will develop additional proprietary technologies or drug
candidates that are patentable; or |
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the patents of others will not have an adverse effect on
Predixs business. |
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Predix may be unable to adequately prevent disclosure of
trade secrets and other proprietary information. |
Predix relies on trade secrets to protect Predixs
proprietary technologies, including Predixs GPCR and ion
channel structures, especially where Predix does not believe
patent protection is appropriate or obtainable. However, trade
secrets are difficult to protect. Predix relies in part on
confidentiality agreements with Predixs employees,
consultants, outside scientific collaborators, sponsored
researchers and other advisors to protect Predixs trade
secrets and other proprietary information. These agreements may
not effectively prevent disclosure of confidential information
and may not provide an adequate remedy if unauthorized
disclosure of confidential information occurs. In addition,
others may independently discover Predixs trade secrets
and proprietary information. Costly and time-consuming
litigation could be necessary to enforce and determine the scope
of Predixs proprietary rights, and failure to obtain or
maintain trade secret protection could adversely affect
Predixs competitive business position. Predix relies on
trade secrets and confidentiality in particular with respect to
Predixs drug discovery technology and any future
competitive advantage provided by it. Predix may not enjoy any
such competitive advantage if Predix is not able to effectively
maintain and enforce any trade secret rights relating to
Predixs drug discovery technology.
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Litigation or other proceedings or third-party claims of
intellectual property infringement would require Predix to spend
time and money and could prevent Predix from developing or
commercializing Predixs drug candidates. |
Predixs commercial success will depend in part on not
infringing the patents and proprietary rights of other parties.
Although Predix is not currently aware of any litigation or
other proceedings or third-party claims of intellectual property
infringement related to Predixs drug candidates, the
pharmaceutical industry is characterized by extensive litigation
regarding patents and other intellectual property rights. Other
parties may obtain patents in the future and claim that
Predixs use of technologies infringes these patents or
that Predix is employing their proprietary technology without
authorization. If another party claims Predix is infringing or
misappropriating its technology, Predix could:
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be required to defend a lawsuit, which is very expensive and
time consuming, even if Predix ultimately prevails; |
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be required to defend against an interference proceeding in the
United States Patent and Trademark Office, which can also be
very expensive and time consuming, regardless of the outcome; |
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receive an adverse decision in a lawsuit or in an interference
proceeding resulting in the loss of some or all of Predixs
rights to Predixs intellectual property, drug products or
drug candidates; |
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be required to pay a large sum for damages, including possible
punitive damages, if Predix is found to be infringing; |
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be prohibited from developing, making, using, selling or
offering for sale Predixs drug candidates until Predix
obtains a license from the infringed party, and this license may
not be granted to Predix at all or may not be granted on
satisfactory terms; and |
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be forced to develop non-infringing products, technologies and
methods which, even if possible, could require substantial
additional capital, could necessitate additional regulatory
approval and could delay commercialization. |
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Although Predix has not received any communications from third
parties challenging Predixs patents or patent applications
covering Predixs drug candidates to date, third parties
may challenge Predixs rights to, or the scope or validity
of, Predixs patents.
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Predix may be subject to claims that Predix or
Predixs employees have wrongfully used or disclosed
alleged trade secrets of their former employers. |
As is commonplace in Predixs industry, Predix employs
individuals who were previously employed at other biotechnology
or pharmaceutical companies, including Predixs potential
competitors. Predix may be subject to claims that these
employees or Predix has inadvertently or otherwise used or
disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend
against these claims. Even if Predix is successful in defending
against these claims, litigation could result in substantial
costs and be a distraction to management.
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Risks Relating to Predixs Israel Operations |
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Political and military instability and other factors may
adversely affect Predixs operations in Israel. |
Predix has significant operations in Israel and regional
instability, military conditions, terrorist attacks, security
concerns and other factors in Israel may directly affect these
operations. Predixs employees in Israel are primarily
computational chemists and are responsible for the computational
chemistry for all of Predixs discovery stage programs.
Accordingly, any disruption in Predixs Israeli operations
could adversely affect Predixs ability to advance
Predixs discovery stage programs into clinical trials.
Since the establishment of the State of Israel in 1948, a number
of armed conflicts have taken place between Israel and its Arab
neighbors. A state of hostility, varying in degree and
intensity, has led to security and economic problems for Israel,
and in particular since 2000, there has been an increased level
of violence between Israel and the Palestinians. Any armed
conflicts or political instability in the region could harm
Predixs operations in Israel. In addition, many of
Predixs employees in Israel are obligated to perform
annual military reserve duty, and, in the event of a war,
military or other conflict, Predixs employees could be
required to serve in the military for extended periods of time.
Predixs operations could be disrupted by the absence for a
significant period of time of one or more of Predixs key
employees or a significant number of Predixs other
employees due to military service. Furthermore, several
countries restrict business with Israel and Israeli companies,
and these restrictive laws and policies could harm Predixs
business.
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THE ANNUAL MEETING OF EPIX STOCKHOLDERS
Date, Time and Place
The annual meeting of EPIX stockholders will be held
on ,
2006, at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., commencing at 10:00 a.m., local time. We are
sending this joint proxy statement/ prospectus to you in
connection with the solicitation of proxies by the EPIX board of
directors for use at the EPIX annual meeting and any
adjournments or postponements of the annual meeting.
Purposes of the EPIX Annual Meeting
The purposes of the EPIX annual meeting are:
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1. To consider and vote upon the issuance of shares of EPIX
common stock in the merger as contemplated by the Agreement and
Plan of Merger, dated as of April 3, 2006, by and among
EPIX Pharmaceuticals, Inc., EPIX Delaware, Inc., a wholly-owned
subsidiary of EPIX, and Predix Pharmaceuticals Holdings, Inc.,
and approve the merger of Predix Pharmaceuticals Holdings, Inc.
with and into EPIX Delaware, Inc.; |
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2. To approve an amendment to EPIXs amended and
restated certificate of incorporation to increase the number of
authorized shares of common stock from 40,000,000 shares to
100,000,000 shares, which represents an additional
60,000,000 shares, as described in this joint proxy
statement/ prospectus; |
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3. To elect two directors for a three-year term to expire
at the 2009 annual meeting of stockholders; provided, however,
that, if the merger is completed, the EPIX board of directors
will consist of the nine persons identified in this joint proxy
statement/ prospectus; |
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4. To ratify the selection of Ernst & Young LLP as
EPIXs independent registered public accounting firm for
the fiscal year ending December 31, 2006; |
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5. To consider and vote on a proposal to approve the
adjournment of the annual meeting, if necessary, to solicit
additional proxies, in the event that there are not sufficient
votes at the time of the annual meeting to approve
Proposal Nos. 1 and 2; and |
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6. To transact such other business as may properly come
before the annual meeting or any adjournment or postponement
thereof. |
Recommendation of EPIXs Board of Directors
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
THE ISSUANCE OF SHARES OF EPIX COMMON STOCK IN THE MERGER IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, EPIX AND ITS
STOCKHOLDERS AND HAS APPROVED SUCH ISSUANCE. THE EPIX BOARD OF
DIRECTORS RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF SHARES OF EPIX
COMMON STOCK IN THE MERGER AND APPROVE THE MERGER.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
AN AMENDMENT TO EPIXS RESTATED CERTIFICATE OF
INCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK FROM 40,000,000 SHARES TO 100,000,000 SHARES, WHICH
REPRESENTS AN ADDITIONAL 60,000,000 SHARES, IS ADVISABLE TO, AND
IN THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH AMENDMENT. THE EPIX BOARD OF DIRECTORS RECOMMENDS
THAT EPIX STOCKHOLDERS VOTE FOR PROPOSAL NO. 2
TO APPROVE AN AMENDMENT TO EPIXS RESTATED CERTIFICATE OF
INCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK FROM 40,000,000 SHARES TO 100,000,000 SHARES. THE
APPROVAL OF PROPOSAL NO. 2 IS NECESSARY TO ENABLE
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EPIX TO ISSUE THE REQUIRED NUMBER OF SHARES OF EPIX COMMON
STOCK TO PREDIX STOCKHOLDERS, OPTION HOLDERS AND WARRANT HOLDERS
IN CONNECTION WITH THE MERGER.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
THE ELECTION OF TWO DIRECTORS FOR A THREE-YEAR TERM TO EXPIRE AT
THE 2009 ANNUAL MEETING OF STOCKHOLDERS IS ADVISABLE TO, AND IN
THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED AND ADOPTED THE PROPOSAL. THE EPIX BOARD OF DIRECTORS
RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 3 TO ELECT TWO DIRECTORS FOR A THREE-YEAR TERM
TO EXPIRE AT THE 2009 ANNUAL MEETING OF STOCKHOLDERS PROVIDED,
HOWEVER, THAT, IF THE MERGER IS COMPLETED, THE EPIX BOARD OF
DIRECTORS WILL CONSIST OF THE NINE PERSONS IDENTIFIED IN THE
ACCOMPANYING JOINT PROXY STATEMENT/ PROSPECTUS.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED THAT THE
RATIFICATION OF THE SELECTION OF ERNST & YOUNG LLP AS
EPIXS INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM FOR
THE FISCAL YEAR ENDING DECEMBER 31, 2006 IS ADVISABLE TO,
AND IN THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH RATIFICATION. THE EPIX BOARD OF DIRECTORS
RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 4 TO RATIFY THE SELECTION OF ERNST &
YOUNG LLP AS EPIXS INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM FOR THE FISCAL YEAR ENDING DECEMBER 31,
2006.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
ADJOURNING THE EPIX ANNUAL MEETING, IF NECESSARY, IF A QUORUM IS
PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT
SUFFICIENT VOTES IN FAVOR OF PROPOSAL NOS. 1 AND 2 IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, EPIX AND ITS
STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE PROPOSAL. THE EPIX
BOARD OF DIRECTORS RECOMMENDS THAT EPIX STOCKHOLDERS VOTE
FOR PROPOSAL NO. 5 TO ADJOURN THE EPIX ANNUAL
MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT
ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF
PROPOSAL NOS. 1 AND 2.
Record Date and Voting Power
Only holders of record of EPIX common stock at the close of
business on the record
date, ,
2006, are entitled to notice of, and to vote at, the EPIX annual
meeting. There were
approximately holders
of record of EPIX common stock at the close of business on the
record date. Because many of
such shares
are held by brokers and other institutions on behalf of
stockholders, EPIX is unable to estimate the total number of
stockholders represented by these record holders. At the close
of business on the record date, shares of EPIX common stock were
issued and outstanding. Each share of EPIX common stock entitles
the holder thereof to one vote on each matter submitted for
stockholder approval. See EPIX Principal
Stockholders for information regarding persons known to
the management of EPIX to be the beneficial owners of more than
5% of the outstanding shares of EPIX common stock.
Voting and Revocation of Proxies
The proxy accompanying this joint proxy statement/ prospectus is
solicited on behalf of the EPIX board of directors for use at
the EPIX annual meeting.
If you are a stockholder of record, you may vote in person at
the annual meeting or vote by proxy using the enclosed proxy
card. Whether or not you plan to attend the meeting, we urge you
to vote by proxy to ensure your vote is counted. You may still
attend the meeting and vote in person if you have already voted
by proxy.
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To vote in person, come to the annual meeting and we will give
you a ballot when you arrive. |
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To vote using the proxy card, simply mark, sign and date your
proxy card and return it promptly in the postage-paid envelope
provided. If you return your signed proxy card to us before the
annual meeting, we will vote your shares as you direct. |
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To vote over the telephone, dial
toll-free using
a touch-tone phone and follow the recorded instructions. You
will be asked to provide the company number and control number
from the enclosed proxy card. Your vote must be received by
11:59 p.m., Eastern Time
on ,
2006 to be counted. |
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To vote on the Internet, go
to to
complete an electronic proxy card. You will be asked to provide
the company number and control number from the enclosed proxy
card. Your vote must be received by 11:59 p.m., Eastern
Time
on ,
2006 to be counted. |
All properly executed proxies that are not revoked will be voted
at the EPIX annual meeting and at any adjournments or
postponements of the annual meeting in accordance with the
instructions contained in the proxy. If a holder of EPIX common
stock executes and returns a proxy and does not specify
otherwise, the shares represented by that proxy will be voted
FOR Proposal No. 1 to approve the issuance
of shares of EPIX common stock in the merger and to approve the
merger; FOR Proposal No. 2 to approve an
amendment to EPIXs restated certificate of incorporation
to increase the number of authorized shares of common stock from
40,000,000 shares to 100,000,000 shares, which
represents an additional 60,000,000 shares; FOR
Proposal No. 3 to elect two directors for a three-year
term to expire at the 2009 annual meeting of stockholders;
provided, however, that, if the merger is completed, the EPIX
board of directors will consist of the nine persons identified
in this joint proxy statement/ prospectus; FOR
Proposal No. 4 to ratify the selection of
Ernst & Young LLP as EPIXs independent registered
public accounting firm for the fiscal year ending
December 31, 2006; and FOR
Proposal No. 5 to adjourn the annual meeting, if
necessary, if a quorum is present, to solicit additional proxies
if there are not sufficient votes in favor of
Proposal Nos. 1 and 2 in accordance with the
recommendation of the EPIX board of directors.
An EPIX stockholder who has submitted a proxy may revoke it at
any time before it is voted at the EPIX annual meeting by
executing and returning a proxy bearing a later date, providing
proxy instructions via the telephone or the Internet (your
latest telephone or Internet proxy is counted), filing written
notice of revocation with the Secretary of EPIX stating that the
proxy is revoked or attending the annual meeting and voting in
person.
Required Vote
The presence, in person or by proxy, at the annual meeting of
the holders of a majority of the shares of EPIX common stock
outstanding and entitled to vote at the annual meeting is
necessary to constitute a quorum at the meeting. Abstentions and
broker non-votes will be counted towards a quorum. The
affirmative vote of the holders of a majority of the shares
present at the EPIX annual meeting, whether in person or by
proxy, is required for approval of Proposal Nos. 1, 4,
5 and 6 above. The affirmative vote of the holders of a majority
of the outstanding common stock on the record date is required
for approval of Proposal No. 2. The affirmative vote
of a plurality of the votes cast in person or by proxy at the
EPIX annual meeting is required for approval of
Proposal No. 3.
Votes will be counted by the inspector of election appointed for
the meeting, who will separately count For,
Withhold and Against votes, abstentions
and broker non-votes. Abstentions will be counted towards the
vote total for each proposal and will have the same effect as
Against votes. Broker non-votes have no effect and
will not be counted towards the vote total for
Proposal Nos. 1, 3, 4, 5 and 6 and will have the
same effect as Against votes with respect to
Proposal No. 2.
At the record date for the EPIX annual meeting, the directors
and executive officers of EPIX owned
approximately %
of the outstanding shares of EPIX common stock entitled to vote
at the meeting.
52
Solicitation of Proxies
In addition to solicitation by mail, the directors, officers,
employees and agents of EPIX may solicit proxies from
EPIXs stockholders by personal interview, telephone,
telegram or otherwise. EPIX will bear the costs of the
solicitation of proxies from its stockholders. Arrangements will
also be made with brokerage firms and other custodians, nominees
and fiduciaries who are record holders of EPIX common stock for
the forwarding of solicitation materials to the beneficial
owners of EPIX common stock. EPIX will reimburse these brokers,
custodians, nominees and fiduciaries for the reasonable
out-of-pocket expenses
they incur in connection with the forwarding of solicitation
materials.
Other Matters
As of the date of this joint proxy statement/ prospectus, the
EPIX board of directors does not know of any business to be
presented at the EPIX annual meeting other than as set forth in
the notice accompanying this joint proxy statement/ prospectus.
If any other matters should properly come before the annual
meeting, it is intended that the shares represented by proxies
will be voted with respect to such matters in accordance with
the judgment of the persons voting the proxies.
53
THE SPECIAL MEETING OF PREDIX STOCKHOLDERS
Date, Time and Place
The special meeting of Predix stockholders will be held
on ,
2006, at the offices of Goodwin Procter LLP, One Exchange Place,
Boston, Massachusetts, commencing at 9:00 a.m., local time.
We are sending this joint proxy statement/ prospectus to you in
connection with the solicitation of proxies by the Predix board
of directors for use at the Predix special meeting and any
adjournments or postponements of the special meeting.
Purposes of the Predix Special Meeting
The purposes of the Predix special meeting are:
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1. To consider and vote upon Proposal No. 1 to
approve and adopt the merger agreement and approve of the merger. |
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2. To consider and vote on Proposal No. 2 to
adjourn the special meeting, if necessary, if a quorum is
present, to solicit additional proxies if there are not
sufficient votes in favor of Proposal No. 1. |
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3. To transact such other business as may properly come
before the special meeting or any adjournments or postponements
of the special meeting. |
Recommendations of Predixs Board of Directors
THE PREDIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE MERGER IS ADVISABLE TO, AND IN THE BEST INTERESTS OF,
PREDIX AND ITS STOCKHOLDERS AND HAS APPROVED THE MERGER AND THE
MERGER AGREEMENT. THE PREDIX BOARD OF DIRECTORS RECOMMENDS THAT
PREDIX STOCKHOLDERS VOTE FOR PROPOSAL NO. 1 TO
APPROVE AND ADOPT THE MERGER AGREEMENT AND APPROVE OF THE
MERGER.
THE PREDIX BOARD OF DIRECTORS HAS CONCLUDED THAT THE
PROPOSAL TO ADJOURN THE PREDIX SPECIAL MEETING, IF
NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT ADDITIONAL PROXIES
IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF THE FOREGOING
PROPOSAL NO. 1 IS ADVISABLE TO, AND IN THE BEST INTERESTS
OF, PREDIX AND ITS STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE
PROPOSAL. ACCORDINGLY, THE PREDIX BOARD OF DIRECTORS RECOMMENDS
THAT PREDIX STOCKHOLDERS VOTE FOR PROPOSAL NO.
2 TO ADJOURN THE PREDIX SPECIAL MEETING, IF NECESSARY, IF A
QUORUM IS PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE
NOT SUFFICIENT VOTES IN FAVOR OF PROPOSAL NO. 1.
Record Date and Voting Power
Only holders of record of Predix common stock and holders of
record of Predix preferred stock at the close of business on the
record
date, ,
2006, are entitled to notice of, and to vote at, the Predix
special meeting. Each share of Predix common stock entitles the
holder thereof to one vote on each matter submitted for
stockholder approval. The shares of Predix preferred stock
entitle the holder thereof to one vote for each share of common
stock into which such shares of preferred stock are convertible.
The outstanding shares of Predix preferred stock currently
convert into common stock on an
18-to-one basis. There
were 118 holders of record of Predix common stock with
1,044,059 shares of common stock issued and outstanding, 63
holders of record of Predix preferred stock, with
273,203,492 shares of Predix preferred stock, which are
convertible into 15,177,898 shares of Predix common stock,
issued and outstanding at the close of business on the record
date. See Predix Principal Stockholders for
information regarding persons known to the management of Predix
to be the beneficial owners of more than 5% of the outstanding
shares of Predix capital stock.
54
Voting and Revocation of Proxies
The proxy accompanying this joint proxy statement/ prospectus is
solicited on behalf of the Predix board of directors for use at
the Predix special meeting.
If you are a stockholder of record, you may vote in person at
the Predix special meeting or vote by proxy using the enclosed
proxy card. Whether or not you plan to attend the meeting, we
urge you to vote by proxy to ensure your vote is counted. You
may still attend the meeting and vote in person if you have
already voted by proxy.
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To vote in person, come to the special meeting and you will be
given a ballot when you arrive. |
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To vote using the proxy card, simply mark, sign and date your
proxy card and return it promptly in the postage-paid envelope
provided. If you return your signed proxy card to us before the
special meeting, we will vote your shares as you direct. |
All properly executed proxies that are not revoked will be voted
at the Predix special meeting and at any adjournments or
postponements of the special meeting in accordance with the
instructions contained in the proxy. If a holder of Predix
common stock or preferred stock executes and returns a proxy and
does not specify otherwise, the shares represented by the proxy
will be voted FOR Proposal No. 1 to
approve and adopt the merger agreement and approve of the merger
and FOR Proposal No. 2 to adjourn the
special meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal No. 1, in accordance with the
recommendation of the Predix board of directors.
A Predix stockholder who has submitted a proxy may revoke it at
any time before it is voted at the Predix special meeting by
executing and returning a proxy bearing a later date, filing
written notice of revocation with the Secretary of Predix
stating that the proxy is revoked or attending the special
meeting and voting in person.
Required Vote
The presence, in person or by proxy, at the special meeting of
the holders of a majority of the shares of Predix common and
preferred stock outstanding (on an as-converted to Predix common
stock basis) and entitled to vote at the Predix special meeting
is necessary to constitute a quorum at the Predix special
meeting. Approval of Proposal No. 1 requires the
affirmative vote of the holders of: (a) a majority of the
common stock and the preferred stock voting as a single class
(on an as-converted to Predix common stock basis), (b) 60%
of the Predix preferred stock voting as a single class (on an
as-converted to Predix common stock basis) and
(c) 662/3
% of the shares of Predix Series C preferred stock
(on an as-converted to Predix common stock basis), in each case,
outstanding on the record date. Abstentions will be counted
towards a quorum and will have the same effect as negative votes
on Proposal No. 1, but will not be counted for any
purpose in determining whether Proposal No. 2 is
approved.
The following Predix stockholders entered into voting agreements
with EPIX on April 3, 2006: Caduceus Private Investment,
L.P., UBS PW Juniper Crossover Fund, L.L.C., Hare and Company
FAO: Finsbury Worldwide Pharma, Yozma II (Israel) L.P.,
Yozma Venture Capital Ltd, YVC-Yozma Management &
Investments Ltd., as trustee for Yozma II (B.V.I.) L.P.,
PCM Venture Capital L.P., Yamanouchi Venture Capital and PA
International Limited. Each has agreed in the voting agreements
to vote all shares of Predix common stock and preferred stock
beneficially owned by each as of the record date in favor of the
approval and adoption of the merger agreement and the approval
of the merger. Each also granted EPIX an irrevocable proxy to
vote their shares of Predix common stock and preferred stock in
favor of the adoption of the merger agreement and the approval
of the merger. Approximately 120,069 shares of Predix
common stock and 6,372,735 shares of Predix preferred stock
(on an as-converted to Predix common stock basis), which
represents approximately 40% of the outstanding Predix voting
stock and as of the record date, are subject to the voting
agreements and irrevocable proxies. See Voting
Agreements.
55
Solicitation of Proxies
In addition to solicitation by mail, the directors, officers,
employees and agents of Predix may solicit proxies from Predix
stockholders by personal interview, telephone, telegram or
otherwise. Predix will bear the costs of the solicitation of
proxies from its stockholders.
Other Matters
As of the date of this joint proxy statement/ prospectus, the
Predix board of directors does not know of any business to be
presented at the Predix special meeting other than as set forth
in the notice accompanying this joint proxy statement/
prospectus. If any other matters should properly come before the
special meeting, it is intended that the shares represented by
proxies will be voted with respect to such matters in accordance
with the judgment of the persons voting the proxies.
56
THE MERGER
This section of the joint proxy statement/ prospectus
describes material aspects of the merger. While EPIX and Predix
believe that the description covers the material terms of the
merger, this summary may not contain all of the information that
is important to you. For a more complete understanding of the
merger, you should carefully read this entire joint proxy
statement/ prospectus, the attached annexes and the other
documents referred to in this joint proxy statement/
prospectus.
General Description of the Merger
At the effective time of the merger, Predix will merge with and
into EPIX Delaware, Inc., a wholly-owned subsidiary of EPIX,
with EPIX Delaware, Inc. surviving the merger as a wholly-owned
subsidiary of EPIX. Predix stockholders will receive shares of
EPIX common stock in exchange for the shares of Predix stock
they own. All options to purchase Predix common stock then
outstanding granted under Predixs 2003 Stock Incentive
Plan and Physiome Sciences, Inc. 1997 Stock Option Plan, as
amended, and all warrants to purchase Predix common stock or
preferred stock then outstanding at the effective time of the
merger shall be assumed by EPIX.
The terms of the merger agreement provide for the issuance of
EPIX common stock to Predix stockholders in exchange for all of
the outstanding shares of Predix, with Predix stockholders
receiving 1.248509 shares of EPIX common stock for each
share of Predix common stock and preferred stock, on an
as-converted to Predix common stock basis, that they hold. Upon
completion of the merger, EPIX stockholders will retain
approximately 53%, and the former Predix stockholders will own
approximately 47%, of outstanding shares of EPIXs common
stock, based on the number of shares of EPIX common stock and
Predix common stock and preferred stock outstanding as of the
date of the merger agreement.
In addition, EPIX will make a milestone payment to Predix
stockholders, option holders and warrant holders in the amount
of $35 million upon the occurrence of certain events. EPIX
may elect to make the milestone payment in cash or shares of
EPIX common stock, or any combination thereof. The milestone
payment will be allocated and paid to each Predix holder of
record of Predix shares, options or warrants that they hold at
the time of the merger, in each case, pro rata based upon the
percentage of the initial merger consideration that such holder
would have received at the time of the merger and assuming that,
for the purpose of the milestone payment only, that each Predix
warrant and option to purchase Predix shares (whether or not
vested) was exercised in full immediately prior to the merger.
In no event will the shares of EPIX common stock issuable at the
effective time of the merger, including the shares of EPIX
common stock issuable upon exercise of Predix options and
warrants assumed by EPIX in the merger, exceed 49.99% of the
outstanding EPIX common stock immediately after the effective
time of the merger.
Predix stockholders, option holders and warrant holders will be
entitled to receive the milestone payment within 90 days
following the occurrence, as determined by the non-Predix
members of the combined companys board of directors,
whether before or after the consummation of the merger, of any
of the following events on or before June 30, 2008:
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receipt of statistically significant final results from a
randomized, placebo- or active comparator- controlled,
double-blinded Phase II or Phase III clinical trial of: |
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PRX-00023 for the treatment of generalized anxiety disorder, or
GAD, depression, attention deficit hyperactivity disorder, or
ADHD, or other neuropsychiatric disorder with at least
100 patients; |
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PRX-03140 for the treatment of Alzheimers disease or other
cognitive disorders with at least 60 patients; |
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PRX-08066 for the treatment of pulmonary artery hypertension, or
PAH, chronic obstructive pulmonary disease, or COPD or a
different indication with at least 60 patients; |
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PRX-07034 for the treatment of obesity, cognitive disorders or a
different indication with at least 60 patients; or |
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entering into a strategic partnership for any Predix drug
candidate, which provides milestone and research funding
payments of more than $50 million, of which
$20 million must be received by June 30, 2008 in
unrestricted cash through non-refundable license fees, research
funding payments, and/or premiums paid in connection with an
equity investment by the strategic partner within 60 days
following entry into the strategic partnership. |
The milestone payment will be paid within 90 days after the
achievement of a milestone event, at the option of the
non-Predix members of the combined companys board of
directors, either:
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in cash, shares of EPIX common stock or any combination thereof
with such shares being valued based on the five-day average
closing price of EPIX common stock on The NASDAQ National Market
ending on the trading day that is ten days prior to the
milestone payment; or |
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$20 million payable in accordance with the preceding bullet
and $15 million payable on the date that is 12 months
after the payment of the initial $20 million in shares of
EPIX common stock, with such shares being valued based on 75% of
the 30-day average
closing price of EPIX common stock on The NASDAQ National Market
ending on the trading day that is ten days prior to the payment
date. If, as a result of the 49.99% limitation described below,
the entire $15 million payment cannot be made in shares of
EPIX common stock, the balance will be paid in cash plus
interest calculated from the milestone payment date at the rate
of 10% per year. |
In no event may the milestone be paid in shares of EPIX common
stock to the extent that such shares would exceed 49.99% of the
outstanding shares of EPIX common stock immediately after such
milestone payment, when combined with all shares of EPIX common
stock issued in the merger and issuable upon exercise of all
Predix options and warrants assumed by EPIX in the merger.
Additionally, the milestone will be paid in cash to the holders
of Predix options and warrants assumed by EPIX in the merger.
Background of the Merger
On September 14, 2005, the EPIX board of directors
appointed Michael J. Astrue as Interim Chief Executive Officer.
Mr. Astrue replaced Michael Webb, who resigned from EPIX
and its board of directors. Mr. Astrue was hired to, among
other things, pursue opportunities for growth beyond the
diagnostic imaging field and to assist the EPIX board of
directors in the search for a permanent Chief Executive Officer.
Beginning prior to his appointment as EPIXs Interim Chief
Executive Officer and continuing thereafter, Mr. Astrue had
informal discussions with members of the EPIX board of directors
about strategies for pursuing opportunities for growth beyond
the diagnostic imaging field. After his appointment in September
2005, Mr. Astrue and the EPIX board of directors agreed to
develop a list of companies with whom to discuss the possibility
of a combination with EPIX. The criteria used to evaluate
potential merger candidates included (a) the number of drug
candidates such companies have in human clinical trials,
(b) the quality and depth of management of the merger
candidate, (c) the geographic location of such companies,
with a clear preference given to Massachusetts-based or virtual
companies, and (d) the avoidance of more speculative
technologies. Based on these criteria, Mr. Astrue and the
EPIX board of directors agreed to develop a list of potential
merger candidates.
During October 2005, EPIX identified approximately
30 companies that broadly matched these criteria. Of these,
ten companies, including Predix, were prioritized as the
companies that most closely matched these criteria.
Mr. Astrue and/or Sheila DeWitt, EPIXs Vice President
of Business Development and Strategic Planning, contacted each
of these companies about the possibility of a combination with
EPIX. Each of the companies contacted during this process was
invited to make a presentation to the EPIX board of directors.
As part of the process of contacting these companies, on
October 23, 2005, Mr. Astrue telephoned
Dr. Michael Kauffman, President and Chief Executive Officer
of Predix. During this conversation Mr. Astrue and
Dr. Kauffman discussed EPIXs potential interest in
acquiring Predix.
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In August 2005, Predix filed with the Securities and Exchange
Commission a registration statement on
Form S-1 covering
the sale of $70,000,000 of Predix common stock in connection
with its proposed initial public offering. In October 2005,
Predix postponed the offering, and subsequently withdrew the
registration statement. The withdrawal of the offering and the
uncertainty of the public equity market required Predix to
consider alternative financing transactions, including
combinations that would result in sufficient capital, now and in
the future, to fund Predixs product development programs.
In late September and early October 2005, EPIX engaged
Dr. Neil Kirby and Dr. Michael Gilman to assist EPIX
in its due diligence review of these companies, specifically to
analyze each companys product development plans and
technology, respectively. Certain of EPIXs existing
consultants also assisted EPIX in its review of these companies.
On October 25, 2005, Dr. Kauffman contacted
Mr. Astrue via
e-mail to indicate that
Predix was interested in participating in EPIXs process
for evaluating potential merger candidates and accepted the
invitation to present an overview of Predixs business and
technology to the EPIX board of directors.
On October 27, 2005, the EPIX board of directors met to
discuss the status of discussions with potential merger
candidates. Three of the merger candidates made presentations to
the EPIX board of directors at this meeting. These presentations
included an overview of the presenting companys business
and technology as well as a rationale for a combination with
EPIX.
On October 28, 2005, EPIX and Predix entered into a
confidentiality agreement.
Throughout October and November 2005, EPIX conducted preliminary
due diligence on each of the potential merger candidates.
On November 1, 2005, EPIX engaged Chestnut Securities, Inc.
to assist EPIX in evaluating the previously identified merger
candidates and to explore other opportunities to diversify.
Throughout November 2005, EPIX and Chestnut Securities had
numerous discussions about the possibility of a combination of
each previously identified merger candidate with EPIX.
Throughout November and December 2005, Predix was also exploring
opportunities to enter into a strategic transaction, and was
conducting active discussions and due diligence with respect to
other potential opportunities.
On November 21, 2005, the EPIX board of directors again met
to discuss the status of discussions with potential merger
candidates. Five of the merger candidates, including Predix,
made presentations to the EPIX board of directors regarding the
possibility of a business combination between such companies and
EPIX. On the basis of these presentations and the preliminary
due diligence performed by EPIXs management, the EPIX
board of directors determined that Predix was an attractive
merger candidate, and instructed EPIXs management to
continue discussions with Predix about the possibility of a
combination of the two companies.
On November 29, 2005, EPIX hired Philip Chase as Interim
Vice President and General Counsel to assist in the analysis,
negotiation and potential consummation of a merger transaction.
On November 29, 2005, the Predix board of directors met to
discuss strategic alternatives following the withdrawal of
Predixs initial public offering, including a possible
merger with a specific merger candidate other than EPIX.
On November 29, 2005, Frederick Frank, Chairman of the
Predix board of directors, telephoned Mr. Astrue to discuss
the potential valuation of Predix.
Between November 29, 2005 and April 3, 2006,
Mr. Astrue and Christopher Gabrieli, Chairman of the EPIX
board of directors, regularly discussed with Mr. Frank and
Dr. Kauffman the proposed terms and structure of a
potential merger between EPIX and Predix.
On December 2, 2005, members of the EPIX board of directors
met with members of EPIX management to discuss the status of
negotiations between EPIX and potential partners.
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On December 2, 2005, EPIX engaged Health Advances to assist
EPIX in conducting due diligence by analyzing the market
potential of product candidates owned or licensed by potential
merger candidates, including Predix.
On December 13, 2005, Predix formally retained Lehman
Brothers as its financial advisor.
On December 14, 2005, Messrs. Astrue, Wirth and
Gabrieli and Albert Holman of Chestnut Securities met with
Dr. Kauffman and Mr. Frank and Jonathan Silverstein, a
director of Predix, at Logan International Airport in Boston,
Massachusetts to discuss the process EPIX intended to use for
evaluating potential merger candidates and the range of possible
valuations of Predix. In addition, there was substantial
discussion about the form of consideration that EPIX would pay
in a transaction and the structure of a transaction. EPIX and
Predix also agreed to begin formal due diligence on one another.
On December 15, 2005, the EPIX board of directors met to
discuss the status of the discussions with the various potential
merger candidates. Based on the previous presentations of the
candidates to the EPIX board of directors and the EPIX board of
directors evaluation of these merger candidates, the EPIX
board of directors decided to narrow the list of potential
merger candidates to four companies, of which Predix was one.
The EPIX board of directors instructed management to continue
negotiations with Predix and three other companies identified as
attractive merger candidates.
On December 15, 2005, the Predix board of directors again
met to discuss strategic alternatives available to Predix. The
Predix board of directors discussed the potential advantages and
disadvantages of either entering into a merger transaction with
one of the two merger candidates, of which EPIX was one, being
considered by Predix, or undertaking a private offering of
Predixs securities.
Between December 15, 2005 and April 3, 2006, the
management team of EPIX met regularly internally and with
EPIXs outside legal and financial advisors to discuss the
status of on-going negotiations and due diligence with the
merger candidates, including Predix.
On December 19, 2005, Dr. Kauffman and other members
of senior management of Predix presented a technical overview of
Predixs lead product candidates to Mr. Astrue and
other members of EPIXs management and consultants at
EPIXs offices in Cambridge, Massachusetts.
On December 21, 2005, Dr. Kauffman contacted
Mr. Gabrieli via
e-mail to discuss the
timing of a potential transaction and the possibility of
EPIXs outside legal advisors beginning the preparation of
the legal documentation, including a merger agreement, for the
proposed transaction while the parties continued due diligence
and discussions concerning structure and consideration.
On December 29, 2005, Mr. Frank telephoned
Mr. Astrue to continue discussions regarding the valuation
of Predix and form of consideration to be paid by EPIX.
Between December 31, 2005 and April 3, 2006, the
management of EPIX and Predix independently met regularly with
their respective outside legal and financial advisors to discuss
the status of ongoing negotiations and due diligence. In
addition, during the same period, representatives of Chestnut
Securities and Lehman Brothers, regularly discussed the terms
and structure of a potential merger between EPIX and Predix and
performed and discussed due diligence.
On January 6 and January 10, 2006, a team of
EPIXs management and EPIXs outside legal and
financial advisors performed due diligence at the offices of
Predixs outside legal advisors in Boston, Massachusetts,
and on January 9, 2006, a team of EPIXs management
and EPIXs advisors performed additional technical due
diligence at the offices of Predix in Lexington, Massachusetts.
On January 12, 2006, Mr. Holman and Mr. Frank
discussed the valuation of EPIX and Predix, the form and amount
of consideration to be paid by EPIX and potential transaction
structure.
On January 20, 2006, Health Advances presented the EPIX
board of directors and consultants a commercial analysis of
Predixs lead product candidate, PRX-00023 for the
treatment of generalized anxiety disorder, or GAD. In addition,
the EPIX board of directors discussed the potential terms of a
transaction with Predix and instructed EPIXs management
and Chestnut Securities to continue to
60
perform due diligence on Predix. In particular, the EPIX board
of directors discussed the valuation of Predix and the
possibility of including a milestone payment relating to
significant clinical efficacy or consummation of a substantial
business development transaction in the potential transaction.
On January 24, 2006, management of EPIX and Health Advances
and Dr. Kauffman and other members of Predixs
management and representatives of Chestnut Securities discussed
the market size for GAD and depression. After these discussions,
EPIX decided to contact individuals identified by Predix and to
engage independent experts to assist the EPIX board of directors
to accurately estimate the potential market size for treatments
for both GAD and depression.
After these discussions, EPIX engaged Dr. Maurizio Fava and
Dr. Jerrold Rosenbaum to assist it in analyzing the
potential safety and efficacy profile of PRX-00023 and
Dr. Brad Hyman to assist it in analyzing the potential
safety and efficacy profile of Predixs second product
candidate, PRX-03140 for the treatment of Alzheimers
disease.
On January 30 and January 31, 2006, representatives of
EPIX and Predix discussed outstanding due diligence items,
including the status of discussions between Predix and potential
out-licensing partners for Predixs product candidates and
the status of potential in-licensing opportunities for EPIX.
On February 1, 2006, Dr. Kauffman and members of
Predixs management met with representatives of Health
Advances at the offices of EPIX in Cambridge, Massachusetts to
discuss Health Advances assessment of the GAD market.
Mr. Astrue and other members of EPIXs management and
EPIX advisors were also present.
On February 7, 2006, several members of Predixs
management conducted due diligence of EPIX at the offices of
EPIX in Cambridge, Massachusetts. Messrs. Chase and Holman
separately discussed with Dr. Kauffman the possibility of
Dr. Kauffman addressing the EPIX board of directors
regarding Predixs lead product candidates and the market
potential of PRX-00023 in each of GAD and depression.
Between February 6 and February 10, 2006,
representatives of Lehman Brothers had several discussions with
representatives of EPIX regarding the proposed terms of the
potential transaction and the upcoming board of directors
meetings of EPIX and Predix, including a discussion of
Dr. Kauffmans proposed presentation.
On February 10, 2006, the EPIX board of directors met to
discuss the status of due diligence and negotiations. At that
meeting, Drs. Fava, Rosenbaum and Hyman presented an
analysis of the risks and potential benefits associated with
PRX-00023 and PRX-03140. Also at that meeting, Dr. Gilman
presented conclusions with respect to the strengths and
weaknesses of Predixs technology platform. Each of
Drs. Fava, Rosenbaum, Hyman and Gilman also answered
questions from members of the EPIX board of directors.
Representatives of Health Advances also led a discussion
regarding additional analyses preformed by them related to
PRX-00023.
Dr. Kauffman also presented Predixs perspective on
the analyses performed by Health Advances and provided an
overview of the potential product pipeline and management of the
combined company. In addition, Mr. Holman discussed a
preliminary financial valuation analysis of Predix with the EPIX
board of directors.
On February 13, 2006, the Predix board of directors
convened by teleconference to discuss the proposed merger
transaction with EPIX, including the proposed deal structure and
terms, and the advantages and disadvantages of the proposed
transaction.
After the February 10, 2006 meeting of the EPIX board of
directors and the February 13, 2006 meeting of the Predix
board of directors, each board of directors authorized
management of their respective company to negotiate the terms of
a merger agreement consistent with the terms generally discussed
at each board of directors meeting.
On February 15, 2006, EPIX engaged Needham &
Company, LLC to assist it in evaluating the potential merger and
valuing Predix.
On February 16, 2006, EPIX provided Predix with the initial
draft of the merger agreement.
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Between February 16 and April 3, 2006, EPIX and
Predix, together with their respective outside legal counsel,
exchanged numerous drafts of the merger agreement and its
various exhibits, including the form of voting agreement, the
form of lock-up agreement and the form of affiliates
agreement. Throughout this period, EPIX and its outside legal
and financial advisors and Predix and its outside legal and
financial advisors engaged in negotiations regarding the merger
agreement and related documentation. During this period, the
parties also discussed termination fees, closing conditions,
possible financing mechanisms for Predix and the terms of
thereof, potential board and management structures of the
combined company and the structure of the transaction.
Throughout this period, representatives of EPIX and Predix
continued their diligence investigation of the other party.
On February 22, 2006, Dr. Kauffman and an advisor met
with Mr. Astrue and his advisors at EPIX to discuss
communication strategies in the event that EPIX and Predix
entered into a transaction.
On February 27, 2006, Mr. Astrue met with a member of
the board of directors and the chief executive officer of a
company he had previous discussions with about a possible
transaction with EPIX, but was not involved in EPIXs
formal review process to again discuss the possible combination
of EPIX and this company.
On March 1, 2006, members of management of EPIX and Predix
met with outside legal advisors and financial advisors at the
offices of Predixs outside legal advisors in Boston,
Massachusetts to discuss significant issues related to a
potential merger between EPIX and Predix and the then current
draft of the merger agreement.
On March 2, 2006, as a follow up to Mr. Astrues
February 27, 2006 meetings, members of EPIXs
management met with members of management of the new merger
candidate to discuss this candidates product portfolio.
On March 3, 2006, Messrs. Gabrieli and Frank discussed
possible financing mechanisms for Predix pending the closing of
any transaction with EPIX, the possibility of making a minimum
stock price for EPIX a closing condition to the merger,
composition of the combined companys board of directors
and management and other issues related to the structure of the
transaction.
On March 6, 2006, the EPIX board of directors met and
discussed the status of negotiations with Predix. The EPIX board
of directors also discussed the possibility of adding additional
members to the EPIX board of directors. The management of the
new merger candidate also presented to the EPIX board of
directors. The EPIX board of directors instructed EPIXs
management to begin due diligence on this company.
Throughout March 2006, members of EPIXs management met
several times with representatives of the new merger candidate
to perform due diligence.
On March 8, 2006, the Predix board of directors convened by
teleconference to discuss the merger transaction. A
representative of Lehman Brothers provided a detailed summary of
the proposed terms of a merger between Predix and EPIX.
Mr. Gabrieli then joined the meeting and presented
EPIXs view of the proposed merger. Following the
presentations, the Predix board of directors discussed the
proposed transaction, after which they authorized Predix to
continue negotiations in connection with a potential merger
transaction with EPIX.
From March 13 through March 27, 2006,
Messrs. Gabrieli and Astrue and Dr. Kauffman, along
with representatives of Chestnut Securities and Lehman Brothers,
discussed at various times the structure, timing and terms of
the proposed transaction as well as possible communication
strategies related to the announcement of the potential merger.
On March 16, 2006, the Predix board of directors met to
discuss the status of the proposed merger transaction with EPIX,
as well as the possibility of a financing of Predix. A
representative of Lehman Brothers provided the directors with an
update regarding the status of negotiations regarding the
structure and terms of the merger transaction with EPIX.
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On March 27, 2006, the EPIX board of directors met
telephonically to discuss the terms of a potential merger with
Predix. In particular, the EPIX board of directors discussed
open issues relating to the size, timing and form of a milestone
payment.
On March 29, 2006, the Predix board of directors convened
by teleconference to discuss the merger transaction as well as a
proposed financing of Predix by certain existing Predix
investors. The Predix board of directors resolved to authorize
Predix to enter into the financing arrangement, along with all
other acts necessary to complete the financing, including
amendments to the certificate of incorporation and the
stockholders agreement.
Between March 29 and April 1, 2006,
Messrs. Gabrieli and Frank and representatives of Chestnut
Securities and Lehman Brothers discussed the circumstances in
which a milestone payment would be paid and the possibility of
deferring a portion of the milestone payment.
On March 30, 2006, the EPIX board of directors met to
discuss the status of and the terms of the potential merger with
Predix. Representatives of Needham & Company, LLC,
financial advisor to EPIX, discussed the results of
Needham & Company, LLCs analyses of stock trading
history, selected recent mergers and acquisitions in the
biotechnology industry, selected recent initial public offerings
of biotechnology companies and selected companies comparable to
Predix. Based on these analyses, a representative of
Needham & Company, LLC reported that, in the opinion of
Needham & Company, LLC, as of March 30, 2006, the
consideration to be paid by EPIX in the proposed acquisition of
Predix is fair to EPIX and its stockholders from a financial
point of view. The board of directors discussed the status of
negotiations, the advisability of entering into the transaction
and provided guidance with respect to how to resolve open issues
in the negotiations between EPIX and Predix.
On April 2, 2006, the parties completed their diligence
reviews and finalized the terms of the merger agreement and
related documentation.
On April 2, 2006, the Predix board of directors convened by
teleconference to discuss the merger agreement and merger,
including the material terms of the transaction and the
consideration to be received by the Predix stockholders.
Following the discussion, the Predix board of directors approved
the merger transaction with EPIX and the merger agreement and
authorized all acts necessary to complete the merger.
On April 2, 2006, the EPIX board of directors met
telephonically. Mr. Holman led a discussion regarding the
resolution to the outstanding issues identified at the meeting
of the board of directors held on March 30, 2006. After
discussion of these issues and other matters relating to the
merger, the EPIX board of directors voted unanimously to approve
the merger with Predix and to recommend that stockholders of
EPIX approve the merger with Predix.
On April 3, 2006, EPIX and Predix entered into a definitive
merger agreement and issued a joint press release announcing the
transaction.
EPIXs Reasons for the Merger
In evaluating the merger, the EPIX board of directors consulted
with EPIXs management, EPIXs outside legal and
financial advisors and external experts in various aspects of
its review of Predixs clinical development programs, the
potential markets for Predixs drug candidates and various
other market analyses. These consultations included, among other
things, extensive discussions regarding: (a) strategic
alternatives to the merger, including extensive discussions of
other potential merger candidates and of continuing to operate
the EPIX business without entering into a merger transaction,
(b) the business and strategic plans of the combined
company and of an independent EPIX, (c) the risks
associated with executing the business and strategic plans of
the combined company and of an independent EPIX, (d) the
financial position of the combined company and of an independent
EPIX, (e) the status of the FDAs approval process for
Vasovist in particular and imaging products in general,
(f) the prospects for executing the EPIX board of
directors previously disclosed strategy of obtaining
therapeutic products through
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internal development, in-licensing transactions, or alternative
transformative transactions, (g) the historical trading
prices of EPIXs common stock and (h) the terms and
conditions of the merger agreement.
The EPIX board of directors also considered that it had
previously made the determination that EPIX should diversify
from the diagnostic imaging business and expand into the
development of therapeutic drug products. Since making that
determination, the EPIX board of directors has examined several
possible means of acquiring therapeutic products, including
through internal development, in-licensing and corporate
acquisitions. In September 2005, the EPIX board of directors
hired Michael J. Astrue as Interim Chief Executive Officer to
thoroughly examine the prospects of EPIX entering into a merger
transaction. In light of EPIXs prior efforts to in-license
technology and to develop therapeutic products internally, EPIX
determined that it needed to supplement those means of obtaining
therapeutic products by exploring the possibility of entering
into a corporate acquisition.
As discussed more fully in the Background of the
Merger above, EPIX entered into a process by which it
examined a number of potential merger candidates and determined
that Predix was the most suitable candidate with which to enter
into a merger transaction. In reaching this determination, the
EPIX board of directors considered a number of additional
positive factors, including the following:
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In examining the quality of potential merger candidates, EPIX
focused on a number of factors, including the depth of the
potential candidates product pipeline. In particular, EPIX
reviewed companies with at least two products in clinical
development. The EPIX board of directors noted that Predix has
three product candidates in clinical development, and that
Predix expects to submit an IND to the FDA for a fourth product
candidate in 2006. The EPIX board of directors also considered
that some of Predixs product candidates are being or will
be investigated for multiple indications. The EPIX board of
directors noted that Predix had as many or more product
candidates in clinical development than any of the other
potential merger candidates considered by the EPIX board of
directors. |
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In examining the quality of potential partners, EPIX also
focused on the presence or absence of a technology platform that
could provide the basis for development of additional product
candidates. The EPIX board of directors noted Predixs drug
development history, including the speed and efficiency with
which Predixs discovery scientists were able to produce
drug candidates with affinity for the intended target receptor
and a lack of affinity for other off-target receptors. The EPIX
board of directors believes that Predixs efficient and
effective drug discovery platform is well-positioned to continue
to deliver product candidates for development by the combined
company. |
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The EPIX board of directors noted that there are a large number
of therapeutics companies that develop therapeutic product
candidates based on technologies that the EPIX board of
directors considers speculative, including gene therapy products
and RNA interference products. The EPIX board of directors
deliberately sought companies whose technology it believed was
less speculative and based on established science and drug
development methods. Although the EPIX board of directors
recognized that substantial risks still remain in the
development of therapeutic products, it noted that Predixs
technology allows for the discovery and development of drug
candidates that interact with clinically and commercially
validated target proteins. The EPIX board of directors believes
that the acceptance of these proteins as viable therapeutic
targets and Predixs ability to develop drug candidates
that have affinity for these target receptors and lack affinity
for other off-target receptors substantially reduces the risks
inherent in drug discovery and development. |
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In examining the quality of potential merger candidates, EPIX
focused on the presence or absence of a strong permanent
management team. The EPIX board of directors noted that
Mr. Astrues agreement with EPIX is currently
scheduled to expire in May 2006. In addition, EPIX has been
without a Chief Financial Officer since July 2005. The EPIX
board of directors also noted that several other of EPIXs
significant management positions are currently filled by
consultants or by employees operating in an interim capacity.
For the foregoing reasons, the EPIX board of directors
considered the capability of the management of each of the
potential merger candidates to lead a |
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combined company after the departure of Mr. Astrue and the
others filling management positions at EPIX on a short-term
basis. The EPIX board of directors believes Dr. Kauffman,
in particular, has the leadership skills and track record of
success in the clinical development of therapeutic products to
lead the combined company. The EPIX board of directors also
noted that strengths of the other members of Predixs
management were highly complementary to the strengths of the
full-time members of EPIXs management team. |
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The EPIX board of directors also considered the commitment of
potential merger candidates to maintain EPIXs core
franchise in medical imaging in order to build a diversified
specialty pharmaceuticals company. |
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The EPIX board of directors noted the difficulties inherent in
combining any two organizations and also noted the significant
incremental difficulty in integrating two organizations that are
geographically diverse. The EPIX board of directors, therefore,
limited its search to companies in and around Boston,
Massachusetts, or to virtual companies whose management
expressed a willingness to move to the greater Boston,
Massachusetts area. Predix, based in Lexington Massachusetts,
clearly met this pre-specified criteria. |
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The EPIX board of directors also considered the opinion that
Needham & Company, LLC rendered that, as of
March 30, 2006, the consideration to be paid by EPIX in the
merger to the equity holders of Predix (including the holders of
options and warrants) was fair, from a financial point of view,
to EPIX and the holders of EPIX common stock. |
The members of the EPIX board of directors also identified and
considered a number of factors, uncertainties and risks,
including the following:
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the risk that the potential benefits of the merger might not be
realized, including the risk that EPIX will not successfully
convert its focus from solely developing diagnostics product
candidates to developing a combination of diagnostic product
candidates and therapeutic product candidates; |
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the fact that Predixs product candidates are at early
stages of development, are subject to significant development
risks and target extremely competitive markets, which the EPIX
board of directors weighed against the portfolio of other
potential transaction candidates that were considered and
against the risks inherent in continuing to pursue the approval
of Vasovist in the United States; |
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the price volatility of EPIXs common stock, which may
increase the value of the EPIX common stock that Predix
stockholders will receive upon the consummation of the merger
and, in particular, possibly result in the holders of Predix
common stock and preferred stock receiving significantly more
consideration in the merger; |
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the inability of EPIXs stockholders to realize the
long-term value of the successful execution of EPIXs
current strategy as an independent company; |
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the possible loss of key management, technical or other
personnel of either of the combining companies as a result of
the management and other changes that will be implemented in
integrating the businesses; |
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the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts; |
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the risk that the merger may not be completed, and that a more
limited range of alternative strategic transactions would be
available to EPIX in that event; |
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the substantial charges expected to be incurred in connection
with the merger, including transaction fees and expenses arising
from or in connection with the merger; and |
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various other applicable risks associated with the combined
company and the merger, including those described under the
section entitled Risk Factors elsewhere in this
joint proxy statement/ prospectus. |
The EPIX board of directors weighed the benefits, advantages and
opportunities of a potential transaction against the negative
factors described above, including the possible diversion of
management attention for an extended period of time. The EPIX
board of directors realized that there can be no assurance about
future results, including results expected or considered in the
factors listed above. However, the EPIX board of directors
concluded that the potential benefits outweighed the potential
risks of completing the merger.
After consideration of the foregoing factors, among others, the
EPIX board of directors has unanimously approved the merger
agreement, the merger and the issuance of EPIX common stock as a
result thereof and recommends approval of the issuance of the
shares of EPIX common stock in the merger, the merger and the
approval of the amendment to EPIXs restated certificate of
incorporation by the shareholders of EPIX.
In reaching its decision, the EPIX board of directors consulted
with EPIXs management with respect to strategic and
operational matters and with EPIXs legal counsel with
respect to the merger agreement and the transactions
contemplated thereby. The EPIX board of directors also consulted
with Chestnut Securities and Needham & Company, LLC
with respect to the financial aspects of the merger.
The preceding discussion of the reasons for the EPIX board of
directors recommendation is not intended to be exhaustive,
but does set forth the principal reasons for the EPIX board of
directors recommendation. The EPIX board of directors did
not quantify or otherwise assign relative weights to the
specific reasons supporting its recommendation. In addition,
individual members of the EPIX board of directors may have given
different weights to different reasons.
Recommendation of EPIXs board of directors
After careful consideration, the EPIX board of directors
unanimously approved the merger agreement and the merger and
determined that the merger and the merger agreement are
advisable, and in the best interests of, the stockholders of
EPIX. Therefore, the EPIX board of directors recommends EPIX
stockholders vote FOR the issuance of the shares of EPIX
common stock in the merger, the approval of the merger and the
approval of the amendment to EPIXs restated certificate of
incorporation by the shareholders of EPIX.
In considering the recommendation of the EPIX board of directors
with respect to the issuance of the shares of EPIX common stock
in the merger, the merger and the approval of the amendment to
EPIXs restated certificate of incorporation, you should be
aware that directors and executive officers of EPIX may have
interests in the merger that are different from, or are in
addition to, the interests of EPIX stockholders. Please see
The Merger Interests of EPIXs Directors
and Management.
Opinion of EPIXs Financial Advisor
The board of directors engaged Needham & Company, LLC,
or Needham & Company, to render a fairness opinion with
respect to the merger. At a meeting of the EPIX board of
directors on March 30, 2006, Needham & Company
delivered its oral opinion, which opinion was subsequently
confirmed in writing, to the effect that, as of March 30,
2006, and based upon and subject to the factors, assumptions and
limitations set forth in the written opinion and described
below, the consideration to be paid by EPIX in the merger to the
equity holders of Predix (including the holders of options and
warrants) was fair, from a financial point of view, to EPIX and
the holders of EPIX common stock.
The amount and form of consideration to be paid in the merger
was determined through arms-length negotiations between
EPIX and Predix and not by Needham & Company.
Needham & Company was not asked to consider, and the
Needham & Company opinion does not address, the
underlying business
66
decision of EPIX to engage in the merger, the relative merits of
the merger as compared to other business strategies that might
exist for EPIX, or the effect of any other transaction in which
EPIX might engage.
The complete text of the written opinion of Needham &
Company, dated March 30, 2006, which sets forth the
assumptions made, matters considered, limitations on and scope
of the review undertaken by Needham & Company, is
attached to this joint proxy statement/ prospectus as
Annex C and is incorporated herein by reference. You are
encouraged to, and should, read the Needham & Company
opinion carefully and this summary of the written opinion of
Needham & Company is qualified in its entirety by
reference to the full text of such opinion. The
Needham & Company opinion is addressed to the EPIX
board of directors and addresses only the fairness, from a
financial point of view, to EPIX and to the holders of EPIX
common stock of the consideration to be paid by EPIX in the
proposed merger to the equity holders of Predix (including the
holders of options and warrants). The Needham & Company
opinion does not address any other aspect of the merger and does
not express an opinion or recommendation to any director,
stockholder or other person as to how to vote or act with
respect to the merger. No limitations were imposed by the EPIX
board of directors with respect to the investigations made or
procedures followed by Needham & Company in rendering
its opinion.
In arriving at its opinion, Needham & Company reviewed
the following:
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(a) a draft of the merger agreement dated March 29,
2006 together with the exhibits and schedules thereto; |
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(b) certain publicly available information concerning EPIX
and Predix, including publicly available filings and the
websites of EPIX and Predix, and certain other relevant
financial and operating data of EPIX and Predix furnished to us
by EPIX and Predix; |
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(c) materials prepared by EPIX concerning the business,
operations and prospects of EPIX and Predix and the combined
company; |
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(d) materials prepared by Predix concerning the business,
operations and prospects of Predix; |
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(e) financial forecasts with respect to EPIX, Predix and
the combined company prepared by the management of EPIX; |
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(f) financial forecasts with respect to Predix prepared by
the management of Predix; |
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(g) certain publicly available financial data of companies
whose securities are traded in the public markets and that
Needham & Company deemed relevant to similar data for
EPIX; |
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(h) the trading history of EPIX common stock; and |
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(i) the financial terms of certain other business
combinations that Needham & Company deemed generally
relevant. |
In addition, Needham & Company held discussions with
members of management of EPIX and Predix concerning the
business, operations and prospects of EPIX, Predix and the
combined company, including the potential cost savings and other
synergies that may be achieved by the combined company.
Needham & Company also performed and/or considered such
other studies, analyses, inquiries, correspondence and
investigations as it deemed appropriate.
In connection with its review and arriving at its opinion,
Needham & Company, with Predixs and EPIXs
consent, assumed and relied upon the accuracy and completeness
of all financial and other information discussed with or
reviewed by Needham & Company for purposes of its
opinion and neither attempted to verify independently nor
assumed responsibility for verifying such information. With
respect to the financial forecasts for EPIX, Predix and the
combined company and the prospects of the combined company
provided to Needham & Company by Predix and EPIXs
managements, Needham & Company assumed, with Predix and
EPIXs consent and based upon discussions with
Predixs and EPIXs managements, that such forecasts
have been reasonably prepared on bases reflecting the best
currently available estimates and judgments of such management,
at the time of preparation, of the future operating
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and financial performance of EPIX, Predix and the combined
company. Needham & Company relied upon the estimates of
EPIX and Predixs managements of the potential cost savings
and other synergies, including the amount and timing thereof,
that may be achieved as a result of the merger.
Needham & Company expressed no opinion with respect to
any of such forecasts or estimates or the assumptions on which
they were based.
Needham & Company relied on advice of counsel given to
EPIX as to all legal matters and advice of independent
accountants given to EPIX as to all financial reporting matters,
all with respect to EPIX, the merger and the draft merger
agreement. Needham & Company did not assume any
responsibility for or make or obtain any independent evaluation,
appraisal or physical inspection of the assets or liabilities of
EPIX or Predix, nor was Needham & Company furnished
with these materials. Needham & Companys services
to EPIX in connection with the merger were comprised of
rendering an opinion of the fairness, from a financial point of
view, of the consideration to be paid by EPIX in connection with
the merger to the equity holders of Predix (including the
holders of options and warrants). Needham &
Companys opinion was necessarily based upon economic,
monetary and market conditions and other circumstances as they
existed and could be evaluated by Needham & Company on
the date of its opinion. It should be understood that, although
subsequent circumstances and events may affect its opinion,
Needham & Company does not have any obligation to
update, revise or reaffirm its opinion and Needham &
Company expressly disclaims any responsibility to do so.
In rendering its opinion, Needham & Company assumed
that the merger would qualify as a reorganization within the
meaning of Section 368(a) of the Code and would be
consummated upon the terms and subject to the conditions set
forth in the merger agreement without material alteration or
variation thereof.
The following is a summary of the principal financial analyses
Needham & Company performed to arrive at its opinion.
Some of the summaries of financial analyses set forth below
include information presented in tabular format. In order to
fully understand the financial analyses, the tables must be read
together with the text of each summary. The tables alone do not
constitute a complete description of the financial analyses.
Considering the data set forth in the tables without considering
the full narrative description of the financial analyses,
including the methodologies and assumptions underlying the
analyses, could create a misleading or incomplete view of the
financial analyses. Additionally, although the financial metrics
of the comparable companies were used for comparison purposes,
none of them is directly comparable to Predix.
To provide contextual data and comparative market data,
Needham & Company reviewed the historical market prices
of EPIX common stock at various points over the last
24 months ended March 28, 2006. Needham &
Company noted that, over the past 24 months, the high and
low closing prices of EPIX common stock were $25.99 and $3.53,
respectively.
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Comparable Transactions Analysis |
Needham & Company reviewed selected data for Predix and
compared this data to corresponding data from a group of 20
selected merger and acquisition transactions, which
Needham & Company believed to be comparable to the
merger based on a number of factors, including but not limited
to the timing of the transaction, whether the companies had
therapeutic programs in a similar stage of development and the
indication targeted to be addressed. Each of the comparable
merger and acquisition transactions involved a transaction
announced and completed since January 1, 2003 and a target
company that had a therapeutic program that was in a similar
stage of development as Predixs therapeutic program. The
comparable merger and acquisition transactions reviewed by
Needham & Company were:
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Xcyte Therapies, Inc.s acquisition of Cyclacel Ltd. |
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Maxim Pharmaceuticals, Incs merger with EpiCept Corporation |
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Corgentech, Incs merger with AlgoRx Pharmaceuticals, Inc. |
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Vernalis plcs acquisition of Cita Neuropharmaceuticals,
Inc. |
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Clinical Data, Incs acquisition of Genaissance
Pharmaceuticals, Inc. |
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Celtic Pharmaceutical Holdings LPs acquisition of Xenova
Group plc |
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Epimmune, Incs merger with IDM Pharma, Inc. |
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GlaxoSmithKline, Inc.s acquisition of Corixa Corporation |
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Cephalon, Inc.s acquisition of Salmedix, Inc. |
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Johnson & Johnsons acquisition of Peninsula
Pharmaceuticals, Inc. |
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Johnson & Johnsons acquisition of TransForm
Pharmaceuticals, Inc. |
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Aphton Corporations acquisition of Igeneon AG |
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VI Technologies, Inc.s merger with Panacos
Pharmaceuticals, Inc. |
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MGI Pharma, Incs acquisition of Zycos, Inc. |
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MGI Pharma, Incs acquisition of Aesgen Pharmaceuticals,
Inc. |
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Amgen Corporations acquisition of Tularik, Inc. |
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Pfizer, Inc.s acquisition of Esperion Therapeutics, Inc. |
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Cell Therapeutics, Inc.s merger with Novuspharma Spa |
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Allergan, Inc.s acquisition of Oculex Pharmaceuticals, Inc. |
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OSI Pharmaceuticals, Inc.s acquisition of Cell Pathways,
Inc. |
The financial and valuation data analyzed as part of this
analysis included:
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Low | |
|
Median | |
|
Mean | |
|
High | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In millions) | |
Initial Equity Purchase Price
|
|
$ |
25.2 |
|
|
$ |
112.2 |
|
|
$ |
260.2 |
|
|
$ |
1,675.2 |
|
Enterprise Value(1)
|
|
$ |
7.2 |
|
|
$ |
91.7 |
|
|
$ |
240.9 |
|
|
$ |
1,486.3 |
|
Enterprise Value(2)
|
|
$ |
7.2 |
|
|
$ |
87.5 |
|
|
$ |
233.3 |
|
|
$ |
1,486.3 |
|
|
|
(1) |
Includes contingent payment |
|
(2) |
Does not include contingent payment |
|
|
|
Comparable Public Companies Analysis |
Needham & Company reviewed selected data for Predix and
compared this data to certain publicly available financial,
operating and stock market data for selected publicly traded
companies that are in the biotechnology industry and have lead
therapeutic programs that Needham & Company believes
are similar to those of Predix, and then analyzed their
relevance and comparability based on various factors, including
but not limited to the sizes of the companies and whether the
company had a therapeutic program in a similar stage of
development. The comparable public companies reviewed by
Needham & Company were:
|
|
|
|
|
Myriad Genetics, Inc. |
|
|
|
Neurochem, Inc. |
|
|
|
Nastech Pharmaceutical Company, Inc. |
|
|
|
Acadia Pharmaceuticals, Inc. |
|
|
|
NeuroSearch A/ S |
69
|
|
|
|
|
Cortex Pharmaceuticals, Inc. |
|
|
|
Amarin Corporation |
|
|
|
Neurogen Corp. |
|
|
|
Cypress Bioscience, Inc. |
|
|
|
Cytrx Corporation |
|
|
|
Corcept Therapeutics, Inc. |
|
|
|
Memory Pharmaceuticals Corp. |
The financial and valuation data analyzed as part of this
analysis included:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable Public Company Values | |
|
|
| |
|
|
(At March 28, 2006) | |
|
|
| |
|
|
Low | |
|
Median | |
|
Mean | |
|
High | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In millions) | |
Equity Value
|
|
$ |
104.8 |
|
|
$ |
206.6 |
|
|
$ |
301.5 |
|
|
$ |
997.8 |
|
Enterprise Value
|
|
$ |
60.4 |
|
|
$ |
158.2 |
|
|
$ |
233.9 |
|
|
$ |
762.7 |
|
For each of these comparable companies, Needham &
Company calculated equity value and enterprise value, based on
closing stock prices on March 28, 2006.
|
|
|
Comparable Biotechnology Initial Public Offerings
Analysis |
Needham & Company reviewed selected data for Predix and
compared this data to certain publicly available financial,
operating and stock market data for selected initial public
offerings of the stock of companies in the biotechnology
industry during the period from January 1, 2005 through
March 28, 2006. The comparable biotechnology initial public
offerings reviewed were:
|
|
|
|
|
Alexza Pharmaceuticals, Inc. |
|
|
|
Iomai Corp. |
|
|
|
SGX Pharmaceuticals, Inc. |
|
|
|
Altus Pharmaceuticals, Inc. |
|
|
|
Somaxon Pharmaceuticals, Inc. |
|
|
|
CombinatoRx Corporation |
|
|
|
Accentia Biopharmaceuticals, Inc. |
|
|
|
Coley Pharmaceutical Group, Inc. |
|
|
|
Advanced Life Sciences Holdings, Inc. |
|
|
|
XenoPort, Inc. |
|
|
|
Aspreva Pharmaceuticals Corp. |
|
|
|
Threshold Pharmaceuticals, Inc. |
|
|
|
Icagen, Inc. |
|
|
|
Favrille, Inc. |
70
The financial and valuation data analyzed as part of this
analysis included:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable IPO Values | |
|
|
| |
|
|
(At March 28, 2006) | |
|
|
| |
|
|
Low | |
|
Median | |
|
Mean | |
|
High | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In millions) | |
Equity Value
|
|
$ |
85.2 |
|
|
$ |
189.7 |
|
|
$ |
203.7 |
|
|
$ |
396.8 |
|
Enterprise Value
|
|
$ |
57.4 |
|
|
$ |
106.0 |
|
|
$ |
132.4 |
|
|
$ |
287.9 |
|
An analysis of the above-presented comparison results is not
purely mathematical, but instead involves complex considerations
and judgments concerning differences in historical financial and
operating characteristics of the companies involved and other
factors that could affect the trading value of such companies.
Although the summary set forth above does not purport to be a
complete description of the analyses performed by
Needham & Company in connection with the rendering of
its opinion, the material analyses performed by
Needham & Company in rendering its opinion have been
summarized above. The preparation of a fairness opinion involves
various determinations as to the most appropriate and relevant
quantitative and qualitative methods of financial analyses and
the application of those methods to the particular
circumstances; and, therefore, such an opinion is not readily
susceptible to partial analysis or summary description.
Needham & Company did not attribute any particular
weight to any analysis or factor considered by it, but rather
made qualitative judgments as to the significance and relevance
of each analysis and factor. Accordingly, Needham &
Company believes, and has advised the EPIX board of directors,
that its analyses must be considered as a whole and that
selecting portions of its analyses or the factors it considered,
without considering all analyses and factors, could create a
misleading or incomplete view of the process underlying its
opinion. In its analyses, Needham & Company made
numerous assumptions with respect to industry performance,
general business and economic conditions and other matters, many
of which are beyond the control of EPIX and Predix or the
combined company. These analyses performed by Needham &
Company are not necessarily indicative of actual values or
predictive of future results or values, which may be
significantly more or less favorable. Additionally, analyses
relating to the values of businesses or assets do not purport to
be appraisals or necessarily reflect the prices at which
businesses or assets may actually be sold. Accordingly, these
analyses and estimates are inherently subject to substantial
uncertainty, being based upon numerous factors or events beyond
the control of EPIX and Predix or the combined company or their
respective advisors. None of EPIX, Predix, the combined company,
Needham & Company or any other person assumes
responsibility if future results are materially different from
those projected. Needham & Companys opinion and
its related analyses were only one of many factors considered by
the EPIX board of directors in its evaluation of the merger and
should not be viewed as determinative of the views of the EPIX
board of directors with respect to the fairness of the total
consideration payable to the equity holders of Predix (including
the holders of options and warrants) in connection with the
merger.
Needham & Company and its affiliates in the ordinary
course of business have from time to time provided, and in the
future may continue to provide, investment banking and financial
advisory services to EPIX and have received, and may in the
future receive, fees for the rendering of such services. In
2004, Needham & Company provided advisory services to
EPIX in connection with a convertible debt offering by EPIX and
received a fee of $458,380.01 in connection therewith. In August
2005, Needham & Company was paid a $50,000 retainer by
EPIX for financial advisory services. A private equity fund,
which is an affiliate of Needham & Company, is a
stockholder of Predix. In addition, Needham & Company
and its affiliates may actively trade the equity securities of
EPIX for their own account or for the accounts of their
customers and, accordingly, may at any time hold a long or short
position in such securities.
Needham & Company received from EPIX a fee of $300,000
in connection with rendering its fairness opinion in this
transaction. In addition to this fee, EPIX will also reimburse
Needham & Company for all of its
out-of-pocket expenses
and EPIX has agreed to indemnify Needham & Company
against certain
71
liabilities, including liabilities under federal securities
laws, in connection with the delivery of its opinion. The terms
of the fee arrangement with Needham & Company, which
are customary in transactions of this nature, were negotiated on
an arms-length basis between EPIX and Needham &
Company, and the EPIX board of directors was aware of the
arrangement, including the fact that a portion of the fee
payable to Needham & Company was contingent upon
delivery of the fairness opinion.
Needham & Company was selected by the EPIX board of
directors to render an opinion to the EPIX board of directors
because Needham & Company is a internationally
recognized investment banking firm and because, as part of its
investment banking business, Needham & Company is
continually engaged in the valuation of businesses and their
securities in connection with mergers and acquisitions,
negotiated underwritings, secondary distributions of listed and
unlisted securities, private placements and valuations for
corporate and other purposes.
Predixs Reasons for the Merger
In approving and authorizing the merger agreement and the
merger, the Predix board of directors considered a number of
factors. Although the following discussion sets forth the
material factors considered by the Predix board of directors in
reaching its determination, it may not include all of the
factors considered by the Predix board of directors. In light of
the number and wide variety of factors considered in connection
with its evaluation of the merger agreement and the merger, the
Predix board of directors did not consider it practicable to,
and did not attempt to, quantify or otherwise assign relative
weights to the specific factors it considered in reaching its
determination. The Predix board of directors viewed its position
and determinations as being based on all of the information
available and the factors presented to and considered by it. In
addition, individual directors may have given different weight
to different factors.
In reaching its decision, the Predix board of directors
consulted with Predixs management with respect to
strategic and operational matters and with Predixs legal
counsel with respect to the merger agreement and the
transactions contemplated thereby. The Predix board of directors
also consulted with Lehman Brothers, Predixs financial
advisor, with respect to the financial aspects of the merger.
Among the factors considered by the Predix board of directors in
its decision to approve the merger agreement were the following:
(a) the judgment, advice and analysis of Predixs
senior management with respect to the potential benefits of the
merger, including EPIXs available resources, intellectual
property and employees, as well as EPIXs liabilities,
based in part on the business, technical, financial, accounting
and legal due diligence investigations performed with respect to
EPIX; (b) historical and current information concerning
Predixs business, including its financial performance and
condition, operations, management and competitive position,
current industry and economic conditions, and Predixs
prospects if it was to remain an independent company, including:
(i) the risk of adverse outcomes in its clinical trials;
and (ii) and its need to obtain additional financing and
the likely terms on which it would be able to obtain that
financing; (c) the current conditions of the equity
markets, as it relates to Predixs ability to raise
additional capital from new investors for the continued growth
of Predixs business, and as it relates to the potential
prospects for the combined company; (d) the current
conditions in the pharmaceutical and biotechnology marketplace
and the positioning of EPIX within that market after the merger;
(e) the status of EPIXs imaging product candidates
and of Predixs drug candidates; and (f) the terms of
the merger agreement, including the merger consideration and
milestone payment, as well as the parties representations,
warranties and covenants and the conditions to their respective
obligations.
In reaching its determination to approve the merger agreement
and the merger, the members of the Predix board of directors
identified and considered a number of the potential benefits of
the merger, including the following:
|
|
|
|
|
the expectation that the merger will be treated as a tax-free
reorganization for U.S. federal income tax purposes; |
72
|
|
|
|
|
the relative percentage ownership of EPIX stockholders and
Predix stockholders in the combined company that is fixed; |
|
|
|
the skills and abilities of the anticipated post-merger
management team; |
|
|
|
given Predixs prospects as a stand-alone entity, it would
be difficult for Predix to raise capital at an attractive
valuation to fund its current business plan, and any such
financing could, therefore, be highly dilutive to Predixs
stockholders; |
|
|
|
that the merger will provide Predix stockholders with shares of
EPIX common stock, a publicly traded company, which would
provide Predix stockholders with the possibility of liquidity; |
|
|
|
the range of options available to the combined organization to
access private and public equity markets to fund future capital
needs, which would likely be greater than the options available
to Predix alone; |
|
|
|
the contribution of EPIXs cash, intellectual property and
other assets to a combined company, which could help accelerate
Predixs development plans and Predixs ability to
generate products while also preserving the accumulated value in
Predixs product candidates and research platform; |
|
|
|
the status of EPIXs product candidates, and the prospect
that they may provide additional sources of revenue sooner than
many of Predixs product candidates; and |
|
|
|
the conclusion of Predixs board of directors that the
$4.5 million termination fee, and the circumstances when
such fee may be payable, were reasonable. |
The members of the Predix board of directors also identified and
considered a number of uncertainties and risks, including the
following:
|
|
|
|
|
the risk that the potential benefits of the merger might not be
realized; |
|
|
|
the price volatility of EPIXs common stock, which may
reduce the value of the EPIX common stock that Predix
stockholders will receive upon the consummation of the merger
and, in particular, possibly result in the holders of Predix
common stock and preferred stock receiving significantly less
consideration in the merger; |
|
|
|
the risk that the $35 million milestone payment may not be
triggered, thereby significantly decreasing the value of the
merger to holders of Predix stock, option and warrants; |
|
|
|
the inability of Predixs stockholders to realize the
long-term value of the successful execution of Predixs
current strategy as an independent company; |
|
|
|
the possible loss of key management, technical or other
personnel of either of the combining companies as a result of
the management and other changes that will be implemented in
integrating the businesses; |
|
|
|
the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts; |
|
|
|
the risk that the merger may not be completed, and that a more
limited range of alternative strategic transactions would be
available to Predix in that event; |
|
|
|
the substantial charges expected to be incurred in connection
with the merger, including transaction fees and expenses arising
from or in connection with the merger; and |
|
|
|
various other applicable risks associated with the combined
company and the merger, including those described under the
section entitled Risk Factors elsewhere in this
joint proxy statement/ prospectus. |
The Predix board of directors weighed the benefits, advantages
and opportunities of a potential transaction against the
negative factors described above, including the possible
diversion of management attention for an extended period of
time. The Predix board of directors realized that there can be no
73
assurance about future results, including results expected or
considered in the factors listed above. However, the Predix
board of directors concluded that the potential benefits
significantly outweighed the potential risks of completing the
merger.
After taking into account these and other factors, the Predix
board of directors approved and authorized the merger agreement
and the transactions contemplated thereby, including the merger.
Recommendation of Predixs board of directors
After careful consideration, the Predix board of directors
approved the merger agreement and the merger and determined that
the merger and the merger agreement are advisable to, and in the
best interests of, the stockholders of Predix. Therefore, the
Predix board of directors recommends Predix stockholders vote
FOR the approval and adoption of the merger agreement and
the approval of the merger.
In considering the recommendation of the Predix board of
directors with respect to the merger agreement and the merger,
you should be aware that directors and executive officers of
Predix may have interests in the merger that are different from,
or are in addition to, the interests of Predix stockholders.
Please see The Merger Interests of
Predixs Directors and Management.
EPIX has obtained the agreement from certain Predix
stockholders, representing approximately 40% of the outstanding
voting power of Predixs capital stock (on an as-converted
to Predix common stock basis), to vote the shares of Predix
capital stock beneficially owned by them in favor of the
approval and adoption of the merger agreement and the approval
of the merger.
Accounting Treatment
EPIX intends to account for the merger as a purchase for
accounting purposes. The total estimated purchase price is
allocated to the net tangible and intangible assets of the
acquired entity based on their estimated fair values as of the
completion of the transaction. A final determination of these
fair values will include managements consideration of a
valuation. This valuation will be based on the actual net
tangible and intangible assets of Predix that exist as of the
closing date of the merger.
Material United States Federal Income Tax Consequences of the
Merger
The following discussion summarizes the material
U.S. federal income tax consequences of the merger that are
expected to apply generally to Predix stockholders upon an
exchange of their Predix common stock and preferred stock for
EPIX common stock in the merger. This summary is based upon
current provisions of the Internal Revenue Code of 1986, as
amended, or the Code, existing Treasury regulations and current
administrative rulings and court decisions, all in effect as of
the date thereof and all of which are subject to change. Any
change, which may or may not be retroactive, could alter the tax
consequences to EPIX, Predix or the Predix stockholders as
described in this summary. No attempt has been made to comment
on all U.S. federal income tax consequences of the merger
that may be relevant to particular holders, including holders
who do not hold their shares as capital assets; holders such as
dealers in securities; banks; insurance companies; other
financial institutions; mutual funds; real estate investment
trusts; tax-exempt organizations; investors in pass-through
entities; stockholders who are subject to the alternative
minimum tax provisions of the Code; stockholders who hold Predix
shares as part of a hedge, wash sale, synthetic security,
conversion transaction, or other integrated transaction;
U.S. holders, as defined below, that have a functional
currency other than the U.S. dollar; traders in securities
who elect to apply a
mark-to-market method
of accounting; stockholders who acquired shares of Predix stock
pursuant to the exercise of options or otherwise as compensation
or through a tax-qualified retirement plan; and certain
expatriates or former long-term residents of the United States.
Stockholders described in this paragraph are urged to consult
their own tax advisors regarding the consequences to them of the
merger.
In case of a stockholder that is a partnership, the
U.S. federal income tax treatment of a partner in the
partnership will generally depend upon the status of the partner
and the activities of the partnership.
74
Partnerships that are holders of Predix common stock or
preferred stock and partners in such partnerships are urged to
consult their own tax advisors regarding the consequences to
them of the merger.
In addition, the following discussion does not address the tax
consequences of the merger under state, local or
non-U.S. tax laws.
Furthermore, the following discussion does not address
(a) the tax consequences of transactions effectuated
before, after or at the same time as the merger, whether or not
they are in connection with the merger, including, without
limitation, transactions in which shares of Predix common stock
or preferred stock are acquired or shares of EPIX common stock
are disposed of, (b) the tax consequences to holders of
options or warrants issued by Predix which are assumed in
connection with the merger or (c) the tax consequences of
the receipt of shares of EPIX common stock other than in
exchange for shares of Predix common stock and preferred stock
pursuant to the merger agreement.
Holders of Predix common stock and preferred stock are urged
to consult their own tax advisors regarding the
U.S. federal income tax consequences of the merger in light
of their personal circumstances and the consequences under
state, local and
non-U.S. tax
laws.
For purposes of this discussion:
|
|
|
|
|
a U.S. holder is a beneficial owner of Predix
common stock or preferred stock, that is (a) an individual
citizen or resident of the United States, (b) a corporation
or any other entity taxable as a corporation created or
organized in or under the laws of the United States or of a
state of the United States or the District of Columbia,
(c) a trust (i) in respect of which a U.S. court
is able to exercise primary supervision over the administration
of the trust and one or more U.S. persons have the
authority to control all substantial decisions of the trust or
(ii) that was in existence on August 20, 1996 and
validly elected to continue to be treated as a domestic trust,
or (d) an estate that is subject to U.S. federal
income tax on its worldwide income from all sources; and |
|
|
|
a
non-U.S. holder
is any individual, corporation, trust or estate which holds
common stock or preferred stock of Predix, other than a
U.S. holder. |
EPIX and Predix intend that the merger will qualify as a
reorganization within the meaning of Section 368(a) of the
Code. As a condition to each partys obligation to
consummate the merger, EPIX and Predix must receive the opinion
of Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo P.C. and
Goodwin Procter LLP, respectively, that the merger will
constitute a reorganization within the meaning of
Section 368(a) of the Code. These tax opinions will be
subject to certain assumptions and qualifications and will be
based in part on the truth and accuracy of certain
representations made by EPIX, EPIX Delaware, Inc. and Predix. No
ruling from the Internal Revenue Service has been or will be
requested in connection with the merger, and Predix stockholders
should be aware that the tax opinions discussed in this section
are not binding on the Internal Revenue Service, the Internal
Revenue Service could adopt a contrary position which could be
sustained by a court. The obligations of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo P.C. and Goodwin Procter LLP to
deliver their tax opinions is conditioned upon, among other
things, the receipt by Predix stockholders in the merger, in the
aggregate, of EPIX common shares with a value equal to at least
40% of the combined value of the total consideration paid for
all Predix shares, taking into account, among other things, the
amount of cash paid or deemed paid to Predix stockholders in
connection with the merger and cash to be paid to Predix
stockholders in lieu of fractional EPIX common shares.
Assuming the merger constitutes a reorganization for federal
income tax purposes:
|
|
|
|
|
each U.S. holder will recognize gain, but not loss, for
federal income tax purposes in an amount equal to the lesser of
(a) the amount of cash such stockholder receives in the
merger or (b) the |
75
|
|
|
|
|
amount, if any, by which the sum of (i) the fair market
value, as of the effective time of the merger, of any EPIX
common shares such stockholder receives in the merger and
(ii) the amount of cash such stockholder receives in the
merger, exceeds such stockholders adjusted tax basis in
its shares of Predix stock; |
|
|
|
the aggregate basis of the shares of EPIX common stock received
by a Predix stockholder in the merger (including any fractional
share deemed received) will be the same as the aggregate basis
of the shares of Predix stock surrendered in exchange therefore,
reduced by the amount of cash received in exchange for shares of
Predix stock in the merger and increased by the amount of gain
recognized in the exchange; |
|
|
|
the holding period of the shares of EPIX common stock received
by a Predix stockholder in the merger will include the holding
period of the shares of Predix common stock or preferred stock
surrendered in exchange therefor; and |
|
|
|
U.S. holder who receives cash in lieu of a fractional share
will recognize gain or loss equal to the difference, if any,
between such stockholders basis in the fractional share
and the amount of cash received. Such gain or loss will be a
long-term capital gain or loss, if the U.S. holders
holding period is greater than one year as of the date of the
closing of the merger. For U.S. holders who are
individuals, any long-term capital gain generally will be taxed
at a premium U.S. federal income tax rate of 15%. The
deductibility of capital losses is subject to limitations. |
For this purpose, gain or loss must be calculated separately for
each identifiable block of shares surrendered in the exchange,
and a loss realized on one block of shares may not be used to
offset a gain realized on another block of shares. Gain
recognized upon the exchange generally will be capital gain,
unless the receipt of cash by a Predix stockholder has the
effect of a distribution of a dividend, in which case the gain
will be treated as dividend income to the extent of the
stockholders ratable share of our earnings and profits as
calculated for federal income tax purposes. Any recognized
capital gain will be long-term capital gain if the stockholder
has held the shares of Predix stock for more than one year.
|
|
|
Certain Requirements for Reorganization under
Section 368(a) |
One of the requirements that must be satisfied for the merger to
qualify as a reorganization under
Section 368(a) of the Code is the continuity of interest
requirement. This requirement will be satisfied if Predix
stockholders exchange a substantial portion of the value of
their proprietary interest in Predix for proprietary interests
in EPIX. In the opinion of Goodwin Procter LLP, the continuity
of interest requirement will be satisfied if the value of EPIX
common shares received in connection with the merger by Predix
stockholders equals or exceeds 40% of the total consideration
paid or deemed paid in exchange for all Predix shares, taking
into account, among other things, the amount of cash paid or
deemed paid to Predix stockholders in connection with the merger
and cash to be paid to Predix stockholders in lieu of fractional
EPIX common shares.
In addition, for the merger to qualify as a
reorganization, EPIXs wholly-owned subsidiary,
EPIX Delaware, Inc., must acquire substantially all of the
assets of Predix. Specifically, EPIX Delaware, Inc. must acquire
at least 70% of the fair value of Predixs gross assets and
at least 90% of the fair value of its net assets. All of
Predixs pre-merger assets must be taken into account in
the calculation. The merger also must satisfy certain other
common law requirements for a reorganization:
continuity of business enterprise and business purpose.
If the merger is not treated as a reorganization
within the meaning of Section 368(a) of the Code, then each
U.S. holder will recognize gain or loss equal to the
difference between the sum of the fair market value of EPIX
common shares and the amount of cash received in the merger
(including cash received in lieu of fractional EPIX common
shares) and such stockholders tax basis in the shares of
Predix common stock and preferred stock surrendered in exchange
therefor. Further, if the merger is not treated as a
reorganization within the meaning of
Section 368(a) of the Code, Predix will be subject to tax
on the deemed sale of its assets to EPIX with gain or loss for
this purpose measured by the difference
76
between Predixs tax basis in its assets and the fair
market value of the consideration deemed to be received
therefor, or, in other words, the cash and EPIX common shares.
This gain or loss would be reported on Predixs final tax
return, subject to the effect of any tax carryovers and the
effect of its other income or loss for that period, and EPIX
Delaware, Inc. would become liable for any such tax liability by
virtue of the merger.
|
|
|
U.S. Holders Backup Withholding and Reporting
Requirements |
A noncorporate Predix stockholder may be subject to backup
withholding at a rate of 28% with respect to a cash payment
received by a Predix stockholder. However, backup withholding
will not apply to a stockholder who either (a) furnishes a
correct taxpayer identification number and certifies that he or
she is not subject to backup withholding by completing the
substitute
Form W-9 that will
be included as part of the letter of transmittal, or
(b) otherwise proves to EPIX and its exchange agent that
the stockholder is exempt from backup withholding. Backup
withholding is not an additional tax. Any amounts withheld under
the backup withholding rules will be allowed as a refund or a
credit against your U.S. federal income tax liability
provided the required information is timely furnished to the
Internal Revenue Service.
Each Predix stockholder that receives EPIX common stock in the
merger will be required to file a statement with his, her or its
federal income tax return setting forth his, her or its basis in
the Predix common stock or preferred stock surrendered and the
fair market value of the EPIX common stock and cash received in
the merger, and to retain permanent records of these facts
relating to the merger.
A non-U.S. holder
of Predix common stock or preferred stock will not be subject to
U.S. federal income or withholding tax on gain with respect
to the merger as long as:
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such gain is not effectively connected with the conduct by the
non-U.S. holder
of a trade or business within the United States or, if a tax
treaty applies, is not attributable to a permanent establishment
or fixed place of business maintained by the
non-U.S. holder in
the United States; |
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in the case of certain capital gains, the
non-U.S. holder
either is not considered, for U.S. federal income tax
purposes, to be present in the United States for 183 days
or more during the taxable year in which the capital gain is
recognized or otherwise qualifies for an exemption; |
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the
non-U.S. holder
qualifies for an exemption from backup withholding, as discussed
below; |
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Predix is not and has not been a U.S. real property holding
corporation at any time within the shorter of the five-year
period ending on the date on which the proposed transaction is
consummated or such
non-U.S. holders
holding period; and |
Generally, a corporation is a U.S. real property
holding corporation if the fair market value of its
U.S. real property interests, as defined in the Code and
applicable regulations, equals or exceeds 50% of the aggregate
fair market value of its worldwide real property interests and
its other assets used or held for use in a trade or business.
Predix does not believe that it is or has been a U.S. real
property holding corporation within the last five years and does
not expect to become a U.S. real property holding
corporation prior to the date of the closing of the merger.
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Non-U.S. Holders
Information Reporting and Backup Withholding |
Payments of cash to Predix stockholders may be subject to backup
withholding at a 28% rate. In order to qualify for an exemption
from backup withholding with respect to cash received in the
merger, a
non-U.S. holder
may be required to provide a taxpayer identification number,
certify the
non-U.S. holders
foreign status or otherwise establish an applicable exemption.
Predix stockholders receiving EPIX common stock may be subject
to information reporting.
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Appraisal Rights
Under Delaware corporate law, Predix stockholders are entitled
to appraisal rights in connection with the merger. Under
Delaware corporate law, holders of EPIX common stock are not
entitled to appraisal rights in connection with the merger. The
text of the relevant provisions of Delaware law are attached to
this joint proxy statement/ prospectus as Annex D.
Federal Securities Laws Consequences
This joint proxy statement/ prospectus does not cover any
resales of the EPIX common stock received in the merger,
and no person is authorized to make any use of this joint proxy
statement/ prospectus in connection with any such resale.
All shares of EPIX common stock received by Predix stockholders
in the merger should be freely transferable, except that if a
Predix stockholder is deemed to be an affiliate of Predix under
the Securities Act of 1933, as amended, at the time of the
special meeting, the Predix stockholder may resell those shares
only in transactions permitted by Rule 145 under the
Securities Act of 1933, as amended, or as otherwise permitted
under the Securities Act of 1933, as amended. Persons who may be
affiliates of Predix under the Securities Act of 1933, as
amended, generally include individuals or entities that control,
are controlled by, or are under common control with, Predix, and
generally would not include stockholders who are not officers,
directors or principal stockholders of Predix. EPIX has agreed
to file a registration statement with respect to the shares of
EPIX common stock to be issued in the merger to persons who are
deemed to be affiliates of Predix. As a result, these shares
shall also be freely tradable upon the effectiveness of this
registration statement, subject only to certain prospectus
delivery requirements and the terms of the
lock-up agreements
described herein, if applicable.
Interests of EPIXs Directors and Management
EPIXs directors and management have interests in the
merger as individuals in addition to, and that may be different
from, the interests of EPIXs stockholders. The EPIX board
of directors was aware of these interests and considered them,
among other matters, in its decision to approve the merger
agreement.
Christopher F.O. Gabrieli, Michael Gilman, Ph.D., Mark
Leuchtenberger and Gregory D. Phelps, each of whom is a current
director of EPIX, is expected to be a member of the EPIX board
of directors after the merger.
Although no employment or similar agreements have been entered
into as of April 24, 2006, it is anticipated that certain
current officers and key employees of EPIX will be executive
officers or key employees of EPIX after the merger as specified
below:
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Name |
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Position in the Combined Company |
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Current Position with EPIX |
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Andrew C.G. Uprichard, M.D.
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President |
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EPIXs President and Chief Operating Officer |
Thomas McMurry, Ph.D.
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Vice President of Imaging Research |
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EPIXs Vice President of Research |
Robert Pelletier, CPA
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Executive Director of Finance (principal accounting
officer) |
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EPIXs Executive Director of Finance |
Philip Graham, Ph.D.
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Vice President of Product Management and Imaging |
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EPIXs Vice President of Program Management |
Brenda Sousa
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Vice President of Human Resources |
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EPIXs Vice President of Human Resources |
Upon completion of the merger, Robert Pelletier, Executive
Director of Finance, and Brenda Sousa, Vice President of Human
Resources, are entitled to a bonus of $48,667 and $47,500,
respectively. In addition, Philip Chase, Vice President and
General Counsel, is entitled to a bonus of $72,000 upon
completion of the merger.
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As a result of the foregoing, the directors and executive
officers of EPIX may be more likely to vote to approve the
merger than EPIX stockholders generally.
Interests of Predixs Directors and Management
Predixs directors and management have interests in the
merger as individuals in addition to, and that may be different
from, the interests of Predixs stockholders. The Predix
board of directors was aware of these interests and considered
them, among other matters, in its decision to approve the merger
agreement.
Patrick J. Fortune, Ph.D., Frederick Frank, Michael G.
Kauffman, M.D., Ph.D., and Ian F. Smith, CPA, ACA, each of
whom is a current director of Predix, is expected to be a member
of the EPIX board of directors after the merger. These
relationships may have influenced their decision to vote in
favor of the merger and to recommend that Predix stockholders
vote in favor of the merger and related transactions. In
addition, certain of the current executive officers or key
employees of Predix are expected to serve as executive officers
or key employees of EPIX at the effective time of the merger.
Moreover, Mr. Frank, the Chairman of the Predix board of
directors, is also the Vice Chairman and a director of Lehman
Brothers Inc., Predixs financial advisor in connection
with the merger. Lehman Brothers is entitled to certain fees and
expenses from Predix upon consummation of the merger. See the
section entitled Current Management of Predix and Related
Information Certain Transactions with Management and
Affiliates.
Pursuant to the merger agreement, upon the completion of the
merger, the combined company will fulfill and honor the
obligations of Predix which existed prior to the merger to
indemnify Predixs present and former directors, officers
and employees. After the completion of the merger, the combined
company will, to the fullest extent permitted under law and
under its certificate of incorporation, indemnify and hold
harmless, each present and former director, officer or employee
of Predix in respect of acts or omissions occurring prior to the
completion of the merger, including in connection with the
merger agreement and the transactions contemplated thereby, to
the same extent as provided in Predixs certificate of
incorporation, by-laws or any applicable contract or agreement
for a period of six years after the completion of the merger.
Certain of the Predix stockholders who have entered into voting
agreements with EPIX, agreeing to vote all shares beneficially
owned by them in favor of approval and adoption of the merger
agreement and approval of the merger, are affiliated with
directors of Predix.
As a result of the foregoing, the directors and executive
officers of Predix may be more likely to vote to approve the
merger than Predix stockholders generally.
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THE MERGER AGREEMENT
The following summary describes certain material provisions
of the merger agreement. The full text of the merger agreement
is attached as Annex A to this joint proxy statement/
prospectus and is incorporated herein by reference. This summary
may not contain all of the information that is important to you,
and you are encouraged to read carefully the entire merger
agreement. The following description is subject to, and is
qualified in its entirety by reference to, the merger
agreement.
The merger agreement is described herein, and included as
Annex A hereto, only to provide you with information
regarding its terms and conditions, and not to provide any other
factual information regarding EPIX, Predix or their respective
businesses. Accordingly, the representations and warranties and
other provisions of the merger agreement should not be read
alone, and you should read the information provided elsewhere in
this document and in the other public filings EPIX makes with
the Securities and Exchange Commission, which are available
without charge at www.sec.gov, for information regarding EPIX
and Predix and their respective businesses. The representations
and warranties described below and included in the merger
agreement were made by each of EPIX, together with EPIX
Delaware, Inc., and Predix to the other. These representations
and warranties were made as of specific dates and may be subject
to important qualifications, limitations and supplemental
information agreed to by EPIX and Predix in connection with
negotiating the terms of the merger agreement. In addition, the
representations and warranties may have been included in the
merger agreement for the purpose of allocating risk between EPIX
and Predix rather than to establish matters as facts.
Structure of the Merger
At the effective time of the merger, Predix will merge with and
into EPIXs wholly-owned subsidiary, EPIX Delaware, Inc.
Upon completion of the merger, EPIX Delaware, Inc. will be the
surviving corporation and a wholly-owned subsidiary of EPIX.
Effective Time of the Transaction
The closing of the transaction contemplated by the merger
agreement will occur no later than the second business day after
the last of the conditions to the transaction have been
satisfied or waived, or at another time as EPIX and Predix may
agree. Contemporaneously with, or as soon as practicable after
the closing, EPIX and Predix will file a certificate of merger
with the Secretary of State of the State of Delaware. The
transaction will become effective upon the filing of this
certificate.
Officers and Directors
At the effective time, the officers of EPIX Delaware, Inc. shall
be the officers of the surviving corporation, subject to change
thereafter, and the directors of EPIX Delaware, Inc. will be the
directors of the surviving corporation.
Conversion of Predix Shares
Each share of Predix common stock and preferred stock (on an
as-converted to Predix common stock basis) issued and
outstanding immediately prior to the effective time of the
merger will be automatically converted into the right to receive
a number of shares of common stock of EPIX equal to the exchange
ratio and cash in lieu of fractional shares.
The Exchange Ratio and Milestone Payment
Every share of Predix common stock and preferred stock (on an
as-converted to Predix common stock basis) issued and
outstanding immediately prior to the effective time shall be
converted into the right to receive 1.248509 shares of
validly issued, fully paid and nonassessable EPIX common stock.
If, after the date of the merger agreement, EPIX or Predix
issues additional equity securities before the effective time,
the exchange ratio shall be adjusted to reflect fully the effect
of the issuance of any
80
such equity securities. The exchange ratio shall be adjusted to
reflect fully the effect of any stock split, reverse split,
stock dividend (including any dividend or distribution of
securities convertible into EPIX common stock), reorganization,
recapitalization or other like change with respect to EPIX
common stock occurring after the date of the merger agreement
and prior to the effective time of the merger.
In addition, EPIX will make a milestone payment to Predix
stockholders, option holders and warrant holders in the amount
of $35 million upon the occurrence of certain events. EPIX
may elect to make the milestone payment in cash or shares of
EPIX common stock, or any combination thereof; provided, that
the milestone payment made to holders of an option or warrant to
purchase Predix common stock or Predix preferred stock shall be
made solely in cash. The milestone payment will be allocated and
paid to each Predix holder of record of Predix shares, options
or warrants that they hold at the effective time of the merger,
in each case, pro rata based upon the percentage of the initial
merger consideration that such holder would have received at the
effective time of the merger and assuming that, for the purpose
of the milestone payment only, that each Predix warrant and
option to purchase Predix shares (whether or not vested) was
exercised in full immediately prior to the effective time of the
merger. In no event will the shares of EPIX common stock
issuable at the effective time of the merger, including the
shares of EPIX common stock issuable upon exercise of Predix
options and warrants assumed by EPIX in the merger, exceed
49.99% of the outstanding EPIX common stock immediately after
the effective time of the merger.
Predix stockholders, option holders and warrant holders will
receive the milestone payment within 90 days following the
occurrence, as determined by the non-Predix members of the
combined companys board of directors, of any of the
following events on or before June 30, 2008:
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receipt of statistically significant final results from a
randomized, placebo- or active comparator-controlled,
double-blinded Phase II or Phase III clinical trial of: |
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PRX-00023 for the treatment of generalized anxiety disorder, or
GAD, depression, attention-deficit hyperactivity disorder, or
ADHD, or other neuropsychiatric disorder with at least
100 patients; |
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PRX-03140 for the treatment of Alzheimers disease or other
cognitive disorders with at least 60 patients; |
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PRX-08066 for the treatment of pulmonary artery hypertension, or
PAH, chronic obstructive pulmonary disease, or COPD, or a
different indication as selected by Predix or, after the
effective time, by the non-Predix members of the combined
companys board of directors, with at least
60 patients; |
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PRX-07034 for the treatment of obesity, cognitive disorders or a
different indication as selected by Predix or, after the
effective time, by the non-Predix members of the combined
companys board of directors, with at least
60 patients; or |
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entering into a strategic partnership for any Predix drug
candidate, which provides milestone and research funding
payments of more than $50 million, of which
$20 million must be received by June 30, 2008 in
unrestricted cash through non-refundable license fees, research
funding payments and/or premiums paid in connection with an
equity investment by the strategic partner within 60 days
following entry into the strategic partnership. |
The milestone payment will be paid within 90 days after the
achievement of a milestone event, at the option of the
non-Predix members of the combined companys board of
directors, either:
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in cash, shares of EPIX common stock or any combination thereof
with such shares being valued based on the five-day average
closing price of EPIX common stock on The NASDAQ National Market
ending on the trading day that is ten days prior to the
milestone payment; or |
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$20 million payable in accordance with paragraph (a)
above and $15 million payable on the date that is
12 months after the payment of the initial $20 million
in shares of EPIX common stock, with such shares being valued
based on 75% of the
30-day average closing
price of EPIX common |
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stock on The NASDAQ National Market ending on the trading day
that is ten days prior to the payment date. If, as a result of
the 49.99% limitation described below, the entire
$15 million payment cannot be made in shares of EPIX common
stock, the balance will be paid in cash plus interest calculated
from the milestone payment date at the rate of 10% per year. |
In no event may the milestone be paid in shares of EPIX common
stock to the extent that such shares would exceed 49.99% of the
outstanding shares of EPIX common stock immediately after such
milestone payment, when combined with all shares of EPIX common
stock issued in the merger and upon exercise of all Predix
options and warrants assumed by EPIX in the merger.
Stock Options and Warrants
At the effective time of the merger, all options to purchase
Predix common stock then outstanding under Predixs Amended
and Restated 2003 Stock Incentive Plan and the Physiome
Sciences, Inc. 1997 Stock Option Plan shall be assumed by EPIX.
At the effective time of the merger, all warrants to purchase
Predix common stock or preferred stock then outstanding shall be
assumed by EPIX.
Fractional Shares
No fractional shares of EPIX common stock will be issued in the
merger. Instead, each holder of Predix common stock and
preferred stock otherwise entitled to receive a fraction of a
share of EPIX common stock shall receive from EPIX an amount of
cash (rounded to the nearest whole cent), without interest,
determined by multiplying that fraction by the average of the
closing sale prices of EPIX common stock on The NASDAQ National
Market on the five trading days ending on the trading day prior
to the effective time of the merger.
Surrender of Predix Certificates
Following the effective time of the merger, the exchange agent,
selected by EPIX, will mail to each holder of Predix common
stock and preferred stock a letter of transmittal and
instructions regarding the details of the exchange. The holders
will use the letter of transmittal to exchange Predix stock
certificates for the shares of EPIX common stock and cash in
lieu of fractional shares of EPIX common stock to which the
holders of Predix common and preferred stock are entitled to
receive in connection with the merger.
After the effective time of the merger and until so surrendered,
outstanding Predix certificates will be deemed to be evidence of
the right to receive EPIX common stock, the right to receive an
amount of cash in lieu of the issuance of any fractional shares
and the right to receive the milestone payment to which the
record holders of Predix common stock and preferred stock are
entitled to receive in connection with the merger. No interest
will be payable on cash distributed to Predix stockholders in
lieu of any fractional shares of EPIX common stock.
United States Tax Consequences
It is intended by both EPIX and Predix that the merger shall
constitute a reorganization within the meaning of
Section 368 of the Internal Revenue Code of 1986, as
amended, or the Code.
Representations and Warranties
The merger agreement contains customary representations and
warranties of EPIX, together with EPIX Delaware, Inc. and Predix
made to, and solely for the benefit of, each other. The
representations and warranties expire at the effective time of
the merger. The assertions embodied in those representations and
warranties are qualified by information in confidential
disclosure schedules that EPIX and Predix have exchanged in
connection with signing the merger agreement. While EPIX and
Predix do not believe that these disclosures schedules contain
information securities laws require the parties to publicly
disclose other
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than information that has already been so disclosed, the
disclosure schedules do contain information that modifies,
qualifies and creates exceptions to the representations and
warranties set forth in the attached merger agreement.
Accordingly, you should not rely on the representations and
warranties as characterizations of the actual state of facts,
since they were only made as of the date of the merger agreement
and are modified in important part by the underlying disclosure
schedules. These disclosure schedules contain information that
has been included in the companies general prior public
disclosures, as well as additional non-public information.
Moreover, information concerning the subject matter of the
representations and warranties may have changed since the date
of the merger agreement, which subsequent information may or may
not be fully reflected in the companies public disclosures.
Conduct of Business Prior to the Completion of the Merger
Under the terms of the merger agreement, EPIX and Predix have
agreed that until the earlier of the termination of the merger
agreement or the effective time of the merger, subject to
certain exceptions, each company will carry on its business in
the ordinary course, in substantially the same manner as
previously conducted. In addition, except as required by law and
subject to certain exceptions, each company has agreed to
additional restrictions that prohibit it from:
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changing its certificate of incorporation or by-laws, or
otherwise altering its corporate structure; |
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selling, pledging, disposing of or encumbering any assets except
for in the ordinary course of business; |
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issuing, disposing of or encumbering any shares of capital stock
of any class, or any options, warrants, convertible securities
or other rights of any kind to acquire any shares of capital
stock, or any other ownership interest except pursuant to stock
options or warrants outstanding on the date of the merger
agreement; |
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accelerating, amending or changing the period of exercisability
of options granted under any stock plans or warrants, as the
case may be, or authorizing cash payments in exchange for any
options or warrants; |
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declaring, setting aside, or paying any dividend or other
distribution in respect of any of its capital stock; |
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splitting, combining, or reclassifying any of its capital stock
or issuing or authorizing or proposing the issuance of any other
securities in respect of, in lieu of or in substitution for
shares of its capital stock; |
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amending the terms of, repurchasing, redeeming or otherwise
acquiring, any of its securities; |
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selling, transferring, licensing, sublicensing or otherwise
disposing of any intellectual property, or amending or modifying
any existing agreements with respect to any intellectual
property; |
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acquiring (by merger, consolidation, or acquisition of stock or
assets or otherwise) any corporation, partnership or other
business organization or division thereof; |
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incurring any indebtedness for borrowed money or assuming,
guaranteeing or endorsing or becoming responsible for the
obligations of any person; |
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making any loans or advances in excess of $100,000 except in the
ordinary course of business consistent with past practice; |
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entering into or amending any material contract or agreement
other than in the ordinary course of business; |
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authorizing any capital expenditures or purchase of fixed assets
which are, in the aggregate, in excess of $100,000, taken as a
whole; |
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increasing the compensation payable or to become payable to its
officers, employees or consultants, except for increases in
salary or wages of employees who are not officers in accordance
with past practices, or granting any severance or termination
pay to, or entering into any employment or severance agreement
with, any director, officer (except for officers who are
terminated on an involuntary basis) or other employee, or
establishing, adopting, entering into or amending any employee
benefit plan, provided, that each may provide their officers and
employees retention bonuses to retain such officers or
employees services through the effective time of the
merger, valued at not more than 20% of such officers or
employees yearly base salary as of the date of the merger
agreement, payable in cash, stock or an option to purchase stock
that becomes payable or vests on or after the effective time of
the merger, if each party has notified the other party in
writing at least five business days prior to granting any such
retention bonus and included in such notification is a
description of the circumstances giving rise to such retention
bonus, provided, further, that the aggregate value of all
retention bonuses granted by each shall not exceed $350,000; |
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taking any action, other than as required by generally accepted
accounting principals, to change accounting policies or
procedures; |
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making any material tax election inconsistent with past
practices or settling or compromising any material federal,
state, local or foreign tax liability or agree to an extension
of a statute of limitations for any assessment of any tax; |
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paying, discharging or satisfying any claims, liabilities or
obligations, other than in the ordinary course of business and
consistent with past practice; |
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entering into any material partnership arrangements, joint
development agreements, strategic alliances or collaborations; |
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except as may be required by law, taking any action to terminate
or amend any employee plans other than in connection with the
merger; or |
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taking any action which would make any of the representations or
warranties of either party contained in the merger agreement to
be untrue or incorrect or prevent either party from performing,
or cause either party not to perform, its covenants thereunder
or result in any of the conditions to the merger not being
satisfied. |
No Solicitation
Both parties have agreed, subject to limitations described
below, that neither Predix and its subsidiaries nor EPIX will
directly or indirectly through any officer, director, employee,
representative or agent, without the prior written consent of
both parties solicit, encourage or have negotiations with
respect to (including by way of furnishing information) the
initiation or submission of any inquiries, proposals or offers
regarding any acquisition, merger, take-over bid, sale of
substantial assets, sale of shares of capital stock (including
without limitation by way of a tender offer) or similar
transactions involving either party, or an Acquisition Proposal;
provided, however, that prior to the adoption of the merger
agreement and the approval of the merger by the stockholders of
Predix or EPIX, as applicable, Predix and EPIX may furnish
nonpublic information regarding such party to any third party in
response to a superior offer that is submitted to such party by
such third party (and not withdrawn) if: (a) such party
shall not have breached the no solicitation provisions of the
merger agreement; (b) the board of directors of such party
concludes in good faith based on the advice of outside legal
counsel, that (i) the failure to take such action would be
inconsistent with the fiduciary duties of the EPIX board of
directors under applicable law, with respect to EPIX and
(ii) taking such action would be required in order to
comply with the fiduciary duties of the Predix board of
directors under applicable law, with respect to Predix and;
(c) such party complies with the provisions of the merger
agreement; and (d) such party receives from such third
party an executed confidentiality agreement containing
provisions at least as favorable to such party as those
contained in the confidentiality agreement dated
October 28, 2005 between EPIX and Predix.
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EPIX and Predix have further agreed (a) that both parties
shall immediately notify the other party after receipt of any
Acquisition Proposal or any request for nonpublic information
relating to either party in connection with an Acquisition
Proposal or for access to the properties, books or records of
either entity by any person or entity that informs the board of
directors of that party that it is considering making, or has
made, an Acquisition Proposal. Such notice to either party shall
be made orally and in writing and shall indicate in reasonable
detail the identity of the offeror and the terms and conditions
of such proposal, inquiry or contact, (b) both parties
shall immediately cease and cause to be terminated any existing
discussions or negotiations with any parties (other than each
other) conducted with respect to any acquisition, merger,
take-over bid, sale of substantial assets, sale of shares of
capital stock (including without limitation by way of a tender
offer) or similar transactions involving either party. Both
parties agree that it will not release any third party from any
confidentiality or standstill agreement to which either is a
party and (c) both parties shall ensure that the officers,
directors and employees of each and any investment banker or
other advisor or representative retained by either party are
aware of these restrictions, and shall be responsible for any
breach of these restrictions by such officers, directors,
employees, bankers, advisors and representatives.
Additional Agreements
Under the terms of the merger agreement EPIX and Predix have
each agreed:
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to file, as promptly as practicable after execution of the
merger agreement, this joint proxy statement/ prospectus with
the Securities and Exchange Commission, and that EPIX will
prepare and file the registration statement in which the joint
proxy statement/ prospectus is included; |
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to cooperate with each other in the preparation and filing of
the joint proxy statement/ prospectus; and |
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to promptly notify one another of any comments from the
Securities and Exchange Commission with respect to the joint
proxy statement/ prospectus. |
In addition, EPIX and Predix have agreed:
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to mail the joint proxy statement/ prospectus to their
respective stockholders at the earliest practicable time after
the registration statement is declared effective by the
Securities and Exchange Commission; |
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to promptly take all steps necessary to hold and convene their
respective stockholders meeting, and use commercially
reasonable efforts to solicit from their respective stockholders
proxies in favor of the adoption of the merger agreement and the
approval of the merger; and |
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that their respective boards of directors shall recommend the
adoption of the merger agreement and the approval of the merger
to their respective stockholders, and, except in certain
circumstances, neither the board of directors of EPIX or Predix
shall withdraw, amend or modify the recommendation. |
Continuing Obligation to Convene Stockholders
Meeting
Notwithstanding anything to the contrary contained in the merger
agreement, both parties will remain obligated to call, give
notice of, convene and hold their respective stockholders
meeting which shall not be limited or affected by the
commencement, disclosure, announcement or submission to either
party of any superior offer.
Confidentiality
Upon reasonable notice and subject to restrictions contained in
confidentiality agreements to which such party is subject,
Predix and EPIX shall each afford to the officers, employees,
accountants, counsel and other representatives of the other,
reasonable access, during the period prior to the effective
time, to all of its and its subsidiaries properties,
books, contracts, commitments and records and, during such
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period, Predix and EPIX each shall furnish promptly to the other
all information concerning its and its subsidiaries
business, properties and personnel as such other party may
reasonably request, and each shall make available to the other
the appropriate individuals (including attorneys, accountants
and other professionals) for discussion of the others
business, properties and personnel as either party may
reasonably request. Each party shall keep such information
confidential in accordance with the terms of the confidentiality
agreement dated October 28, 2005 between EPIX and Predix.
Regulatory Filings
Predix, EPIX and EPIX Delaware, Inc. shall coordinate and
cooperate with one another and shall use all commercially
reasonable efforts to comply with all legal requirements and
make all filings required by any governmental entity in
connection with the merger and related transactions contemplated
by the merger. Predix and EPIX shall prepare and file, if any,
(a) the notification, report and any forms required to be
filed under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended, or the HSR Act, and (b) as
promptly as practicable thereafter respond in compliance with
any inquiries or requests received from the Federal Trade
Commission, the Department of Justice or from any state attorney
general, foreign antitrust or competition authority or other
governmental authority in connection with antitrust or
competition matters. Predix and EPIX will notify the other
promptly upon the receipt of any comments, responses or requests
from any governmental entity or official in connection with any
filings made pursuant to the merger agreement and the merger.
Notification of Certain Matters
Predix shall give prompt notice to EPIX, and EPIX shall give
prompt notice to Predix, of (a) the occurrence, or
non-occurrence, of any event the occurrence, or non-occurrence,
of which would be likely to cause any representation or warranty
contained in the merger agreement to be materially untrue or
inaccurate, and (b) any failure of Predix or EPIX, as the
case may be, materially to comply with or satisfy any covenant,
condition or agreement to be complied with or satisfied by it
thereunder; provided, however, that the delivery of any notice
pursuant to the merger agreement shall not limit or otherwise
affect the remedies available thereunder to the party receiving
such notice; and provided, further, that failure to give such
notice shall not be treated as a breach of covenant for the
purposes of the merger agreement unless the failure to give such
notice results in material prejudice to the other party.
Each of Predix and EPIX shall give prompt notice to the other of
(a) any notice or other communication from any person
alleging that the consent of such person is or may be required
in connection with the merger or other transactions contemplated
by the merger agreement; (b) any notice or other
communication from any governmental authority in connection with
the merger or other transactions contemplated by the merger
agreement; (c) any litigation relating to or involving or
otherwise affecting Predix, its subsidiaries or EPIX that
relates to the merger or other transactions contemplated by the
merger agreement; (d) the occurrence of a default or event
that, with notice or lapse of time or both, is reasonably likely
to become a default under a Predix contract; and (e) any
change that would be considered reasonably likely to result in a
material adverse effect, or is likely to impair in any material
respect the ability of either Predix or EPIX to consummate the
transactions contemplated by the merger agreement.
Indemnification
From and after the merger, EPIX Delaware, Inc., as the surviving
corporation, will fulfill and honor in all respects the
obligations of Predix which exist prior to the date thereof to
indemnify Predixs present and former directors, officers,
employees and their heirs, executors and assigns. The
certificate of incorporation and by-laws of EPIX Delaware, Inc.
will contain provisions with respect to indemnification and
elimination of liability for monetary damages set forth in
Predixs restated certificate of incorporation, as amended,
and by-laws on the date of the merger agreement, which
provisions will not be amended, repealed or otherwise modified
for a period of six years from the merger in any manner that
would adversely affect the rights thereunder of individuals who,
at the time of the merger, were directors,
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officers, employees or agents of Predix, unless such
modification is required by law and then only to the minimum
extent required by such law.
Predix shall use commercially reasonable efforts, after
consultation with EPIX, to negotiate and secure a
tail on its existing directors, officers and company
liability insurance policies for a period of six years, at a
total cost not to exceed $25,000 per year of coverage,
which cost shall be paid by EPIX.
Listing of EPIX Common Stock
EPIX shall use its reasonable best efforts to cause the shares
of EPIX common stock to be issued in the merger to be approved
for listing on The NASDAQ National Market prior to the effective
time of the merger.
Public Announcements
EPIX and Predix shall consult with each other before issuing any
press release or otherwise making any public statements with
respect to the merger and shall not issue any such press release
or make any such public statement without the prior consent of
the other parties, which shall not be unreasonably withheld or
delayed; provided, however, that, on the advice of legal
counsel, EPIX may comply with any Securities and Exchange
Commission requirements under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended,
which requires any public disclosure, without the consent of
Predix.
Taxes
EPIX and Predix shall cooperate in the preparation, execution
and filing of all returns, questionnaires, applications or other
documents regarding any real property transfer or gains, sales,
use, transfer, value added, stock transfer and stamp taxes, any
transfer, recording, registration and other fees, and any
similar taxes which become payable in connection with the
transactions contemplated by the merger agreement that are
required or permitted to be filed on or before the effective
time of the merger. EPIX shall pay all such taxes and fees.
Severance Payments
If at any time between the effective time of the merger and the
12-month anniversary of
the effective time of the merger, EPIX, the surviving
corporation or its subsidiaries causes certain employees that
were employed by EPIX, Predix or its subsidiaries as of the
effective time of the merger to be terminated for any reason
other than cause or to resign as a result of a substantial
diminution of salary, such employee shall be entitled to certain
severance payments from EPIX, EPIX Delaware, Inc. or their
subsidiaries, as the case may be, as set forth in the merger
agreement.
EPIX Board of Directors
The EPIX board of directors shall cause the EPIX board of
directors, immediately after the effective time, to consist of
no more than nine persons, and, with respect to such board of
directors: (a) to appoint four Predix nominees, which shall
include Frederick Frank, Michael G.
Kauffman, M.D., Ph.D., Patrick J. Fortune, Ph.D.
and Ian F. Smith, CPA, ACA, (b) to appoint five EPIX
nominees, which may include EPIXs directors immediately
prior to the effective time of the merger. In addition, EPIX
shall cause the Chief Executive Officer of Predix immediately
prior to the effective time of the merger to be the Chief
Executive Officer of EPIX immediately after the effective time
of the merger pursuant to an employment agreement upon mutually
agreeable terms and conditions.
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Treatment as Reorganization
Predix, EPIX and EPIX Delaware, Inc. will not take any action
prior to or after the effective time of the merger that would
reasonably be expected to cause the merger to fail to qualify as
a reorganization with the meaning of Section 368(a) of the
Code.
Conditions to the Completion of the Merger
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Conditions to Obligations of Each Party |
The obligations of EPIX and Predix to effect the transaction are
subject to the satisfaction or waiver of various conditions,
which include the following:
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the registration statement relating to the shares of EPIX common
stock to be issued in connection with the merger, of which this
joint proxy statement/ prospectus is a part, shall have been
declared effective by the Securities and Exchange Commission
under the Securities Act of 1933, as amended, and no stop order
suspending the effectiveness of the registration statement shall
have been issued by the Securities and Exchange Commission nor
shall such proceeding have been initiated or, to the knowledge
of EPIX and Predix, threatened by the Securities and Exchange
Commission; |
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all approvals of, declarations or filings, with any governmental
authority necessary for the consummation of the merger, if any,
shall have been obtained or made, including the expiration or
termination of the waiting period (and any extension thereof)
under the HSR Act, if required; |
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the merger agreement shall have been adopted by the requisite
vote of the stockholders of EPIX and Predix, respectively, in
accordance with General Corporation Law of the State of Delaware
and EPIXs and Predixs respective certificates of
incorporation and by-laws; and the issuance of shares of EPIX
common stock by virtue of the merger shall have been approved by
the requisite vote of the stockholders of EPIX under the rules
of the Securities and Exchange Commission and the National
Association of Securities Dealers, Inc.; |
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no order (whether temporary, preliminary or permanent) issued by
any court of competent jurisdiction or other legal restraint or
prohibition preventing the consummation of the merger shall be
in effect, nor shall any proceeding brought by any governmental
authority seeking any of the foregoing be pending; |
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EPIX and Predix shall have received the written opinion of
Goodwin Procter LLP and Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., respectively, to the effect that the merger
will constitute a reorganization within the meaning of
Section 368 of the Code; and |
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no injunction, or final, non-appealable judgment, decree or
order issued by any court of competent jurisdiction shall be in
effect which would result in the acceleration of payment of the
amounts outstanding under that certain Indenture, dated as of
June 7, 2004, between EPIX and U.S. Bank National
Association, as trustee, or any notes issued thereunder. |
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Additional Conditions to the Obligations of EPIX |
The obligations of EPIX to effect the merger shall be subject to
the satisfaction at or prior to the effective time of the merger
of each of the following conditions:
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the representations and warranties of Predix contained in the
merger agreement shall be true and correct in all respects on
and as of the effective time; |
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Predix shall have performed or complied with all agreements and
covenants required by the merger agreement to be performed or
complied with by it on or prior to the effective time of the
merger; |
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there shall not have been instituted, pending or threatened any
action or proceeding by any governmental authority, nor shall
there be in effect any judgment, decree or order of any |
88
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governmental authority, in either case, seeking to prohibit or
limit EPIX from exercising all material rights and privileges
pertaining to its ownership of the surviving corporation; |
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there shall have been no change, occurrence or circumstance in
the business, results of operations or financial condition of
Predix or any subsidiary of Predix having or reasonably likely
to have, individually or in the aggregate, a material adverse
effect on Predix; |
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EPIX shall have received from each affiliate of Predix, the
affiliate agreements, described elsewhere in this joint proxy
statement/ prospectus, and such agreement shall be in full force
and effect; |
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Predix shall have received all consents and approvals required
to consummate the merger under Predixs and its
subsidiaries agreements listed in the merger agreement; |
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stockholders of Predix holding an aggregate of approximately 40%
of the voting shares of Predix shall have entered into voting
agreements, described elsewhere in this joint proxy statement/
prospectus, and such agreements shall be in full force and
effect; and |
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EPIX shall have received from Goodwin Procter LLP, counsel to
Predix, an opinion, addressed to EPIX dated as of the effective
date of the merger. |
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Additional Conditions to the Obligations of Predix |
The obligations of Predix to effect the merger shall be subject
to the satisfaction at or prior to the effective time of the
merger of each of the following conditions:
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the representations and warranties of EPIX contained in the
merger agreement shall be true and correct in all respects on
and as of the effective time; |
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EPIX shall have performed or complied with all agreements and
covenants required by the merger agreement to be performed or
complied with by it on or prior to the effective time of the
merger; |
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there shall not have been instituted, pending or threatened any
action or proceeding (or any investigation or other inquiry that
might result in such an action or proceeding) by any
governmental authority, nor shall there be in effect any
judgment, decree or order of any governmental authority, in
either case, seeking to prohibit or limit Predix from exercising
all material rights and privileges pertaining to its ownership
of the surviving corporation; |
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there shall have been no change, occurrence or circumstance in
the business, results of operations or financial condition of
EPIX having or reasonably likely to have, individually or in the
aggregate, a material adverse effect on EPIX; |
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the EPIX common stock shall be listed on The NASDAQ National
Market as of and from the date of the merger agreement through
the consummation of the merger and the shares of EPIX common
stock issued in the merger shall have been approved for listing
on The NASDAQ National Market as of the consummation of the
merger; |
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Predix shall have received from Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C., counsel to EPIX, an opinion,
addressed to Predix dated as of the effective date of the merger; |
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the sum of EPIXs cash, cash equivalents, restricted cash
and securities available for sale at the effective time of the
merger less the aggregate amount of any and all liabilities and
obligations associated with (a) severance or similar
obligations of EPIX as of the effective time; (b) fees
payable to any financial advisor to EPIX; (c) fees owed or
payable to EPIXs independent public accountants;
(d) bonus payments to employees upon consummation of the
merger; and (e) legal fees of EPIX in connection with the
negotiation and execution of the merger agreement and
consummation of the merger shall be no less than the
$110 million; |
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EPIX shall have caused the board of directors of EPIX to be
constituted as set forth the merger agreement; and |
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each of the current officers of EPIX who is not named in the
merger agreement shall have delivered to EPIX their written
resignations as officers of EPIX and each of the individuals
named in the merger agreement shall have been appointed officers
of EPIX. |
Termination of the Merger Agreement
The merger agreement may be terminated at any time before the
effective time of the merger, notwithstanding approval thereof
by the board of directors and stockholders of Predix and EPIX,
under the following circumstances:
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by mutual written consent duly authorized by the board of
directors of EPIX and Predix; |
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by either EPIX or Predix if the merger shall not have been
consummated by July 31, 2006; provided, that the right to
terminate the merger agreement for this reason shall not be
available to any party whose failure to fulfill any obligation
under the merger agreement has been the cause of or resulted in
the failure of the merger to occur on or before such date; |
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by either EPIX or Predix if a court of competent jurisdiction or
governmental, regulatory or administrative agency or commission
shall have issued a non-appealable final order, decree or ruling
or taken any other action prohibiting the merger; |
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by EPIX, if the board of directors of Predix shall have withheld
or withdrawn its recommendation in favor of the merger, or if
there shall have occurred any material adverse effect with
respect to Predix since the date of the merger agreement; |
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by Predix, if the board of directors of EPIX shall have withheld
or withdrawn its recommendation in favor of the merger, or if
there shall have occurred any material adverse effect with
respect to EPIX since the date of the merger agreement; |
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by either EPIX or Predix, if the required approval of the
stockholders of EPIX or Predix shall not have been obtained by
reason of the failure to obtain the requisite vote, provided,
that the right to terminate the merger agreement for this reason
shall not be available to any party where the failure to obtain
stockholder approval of such party shall have been caused by the
action or failure of such party in breach of the merger
agreement; |
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by either EPIX or Predix, upon a breach of any covenant or
agreement on the part of Predix or EPIX, respectively, set forth
in the merger agreement, in either case, such that certain
conditions set forth in the merger agreement, would not be
satisfied, or a Terminating Breach, provided, that, if such
Terminating Breach is curable through the exercise of
commercially reasonable efforts prior to the expiration of five
days from its occurrence (but in no event later than
July 31, 2006) by EPIX or Predix, neither Predix nor EPIX,
respectively, may terminate the merger agreement unless such
5-day period expires
without such Terminating Breach having been cured; or |
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by either EPIX or Predix, if such party is not in material
breach of any of its respective obligations under the merger
agreement, if any representation or warranty on the part of the
other party set forth in the merger agreement proves to have
been untrue on the date of thereof, if such failure to be true
would reasonably be likely to have a material adverse effect. |
Notice/ Effect of Termination
Any termination of the merger agreement will be effective
immediately upon the delivery of written notice of the
terminating party to the other parties thereto. In the event of
the termination of the merger agreement, the merger agreement
shall forthwith become void and there shall be no liability on
the part of any party thereto or any of its affiliates,
directors, officers or stockholders except that nothing therein
shall relieve any party from liability for any willful breach
thereof. No termination of the merger agreement shall affect the
obligations of the parties contained in the confidentiality
agreement dated October 28, 2005 between EPIX and Predix.
90
Fees and Expenses
Except as set forth in the merger agreement, all fees and
expenses incurred in connection with the merger agreement and
the transactions contemplated thereby shall be paid by the party
incurring such expenses, whether or not the merger is
consummated. In addition, EPIX shall be solely responsible for
all fees and expenses incurred in relation to the preparation,
printing and filing of this joint proxy statement/ prospectus
(including the preliminary materials related thereto) and the
registration statement of which this joint proxy statement/
prospectus forms a part, in each case, including without
limitation any amendments or supplements thereto.
Predix shall pay EPIX a fee of $4.5 million upon the
termination of the merger agreement by EPIX if:
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there is an uncured breach of any covenant or agreement; |
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the board of directors of Predix shall have withheld or
withdrawn its recommendation in favor of the merger; |
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there shall have occurred any material adverse effect with
respect to Predix since the date of the merger agreement; or |
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Predix fails to obtain the requisite stockholder vote to approve
the merger. |
EPIX shall pay Predix a fee of $4.5 million upon the
termination of the merger agreement by Predix if:
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there is an uncured breach of any covenant or agreement; |
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the board of directors of EPIX shall have withheld or withdrawn
its recommendation in favor of the merger; |
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there shall have occurred any material adverse effect with
respect to EPIX since the date of the merger agreement; or |
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EPIX fails to obtain the requisite stockholder vote to approve
the merger. |
The fee payable pursuant to a termination under the merger
agreement shall be paid within three business days after the
first to occur of the events described in such sections.
Amendment and Waiver
The merger agreement may be amended by the parties thereto by
action taken by or on behalf of their respective boards of
directors at any time prior to the effective time; provided,
however, that, after approval of the merger by the boards of
directors and stockholders of EPIX and Predix, no amendment may
be made which by law requires further approval by such
stockholders or boards of directors without such further
approval. The merger agreement may not be amended except by an
instrument in writing signed by the parties thereto.
At any time prior to the effective time, any party to the merger
agreement may, with respect to any other party thereto,
(a) extend the time for the performance of any of the
obligations or other acts, (b) waive any inaccuracies in
the representations and warranties contained therein or in any
document delivered pursuant thereto and (c) waive
compliance with any of the agreements or conditions contained
therein. Any such extension or waiver shall be valid if set
forth in an instrument in writing signed by the party or parties
to be bound.
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THE VOTING AGREEMENTS
The following description of the voting agreements describes
the material terms of the voting agreements. This description of
the voting agreements is qualified in its entirety by reference
to the form of voting agreement which is attached as
Annex B to this joint proxy statement/ prospectus and is
incorporated herein by reference. EPIX and Predix encourage you
to read the entire form of voting agreement.
The following Predix stockholders entered into each entered into
voting agreements with EPIX on April 3, 2006: Caduceus
Private Investment, L.P., UBS PW Juniper Crossover Fund, L.L.C.,
Hare and Company FAO: Finsbury Worldwide Pharma, Yozma II
(Israel) L.P., Yozma Venture Capital Ltd, YVC-Yozma
Management & Investments Ltd., as trustee for
Yozma II (B.V.I.) L.P., PCM Venture Capital L.P.,
Yamanouchi Venture Capital and PA International Limited. In the
voting agreements, each has agreed to vote all shares of Predix
common stock and preferred stock beneficially owned by them as
of the record date (a) in favor of the approval and
adoption of the merger agreement and the approval of the merger,
(b) against any action that would preclude fulfillment of a
condition under the merger agreement to EPIXs or EPIX
Delaware, Inc.s obligation to consummate the merger,
(c) against any action or agreement that would result in a
breach in any material respect of any covenant, representation
or warranty or any other obligation of Predix under the merger
agreement and (d) against any acquisition transaction
(other than the one contemplated by the merger agreement). In
addition, they have each granted EPIX an irrevocable proxy to
vote their shares of Predix common stock and preferred stock in
the manner set forth above. Further, each has agreed that it
will not (a) solicit proxies or participate in a
solicitation in opposition to or in competition with the
approval of the merger agreement or take any other action that
would compete with or interfere with the timely consummation of
the merger, (b) directly or indirectly encourage, initiate
or cooperate in a stockholders vote or action by written
consent of Predixs stockholders in opposition to or in
competition with the approval of the merger agreement, or
(c) become a member of a group with respect to any voting
securities of Predix for the purpose of opposing or competing
with the approval of the merger agreement. During the term of
the voting agreements, each has also agreed to not transfer,
sell, offer, exchange, pledge or otherwise dispose of any shares
of Predix common stock and preferred stock, or any options to
purchase shares of Predix common stock, owned by them.
Approximately 120,069 shares of Predix common stock and
6,372,735 shares of Predix preferred stock (on an
as-converted to Predix common stock basis), which represents
approximately 40% of the outstanding shares of Predix voting
stock as of April 3, 2006 are subject to voting agreements
and irrevocable proxies. The voting agreements will terminate on
the earlier of the consummation of the merger or termination of
the merger agreement pursuant to its terms.
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MANAGEMENT OF EPIX AFTER THE MERGER
Management and Board of Directors of EPIX After the Merger
Upon consummation of the merger, the EPIX board of directors is
expected to be comprised of nine members. The following table
lists the names, ages and positions of individuals designated by
EPIX and Predix to be the management team and key employees of
EPIX upon consummation of the merger and the expected members of
the EPIX board of directors after the merger. The ages of the
individuals are provided as of April 15, 2006.
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Age | |
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Position |
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Management Team:
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Michael G. Kauffman M.D., Ph.D.*
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42 |
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Chief Executive Officer (principal executive officer) |
Andrew C.G. Uprichard, M.D.*
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49 |
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President |
Kimberlee C. Drapkin, CPA*
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38 |
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Chief Financial Officer (principal financial officer) |
Oren Becker, Ph.D.*
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45 |
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Chief Scientific Officer |
Stephen R. Donahue, M.D.
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41 |
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Vice President of Clinical & Regulatory Affairs |
Philip Graham, Ph.D.
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43 |
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Vice President of Product Management and Imaging |
Thomas McMurry, Ph.D.
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48 |
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Vice President of Imaging Research |
Silvia Noiman, Ph.D.*
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50 |
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Senior Vice President of Pipeline Management, General Manager
Israel |
Robert Pelletier, CPA*
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53 |
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Executive Director of Finance (principal accounting
officer) |
Chen Schor, CPA*
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33 |
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Chief Business Officer |
Sharon Shacham, Ph.D.
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35 |
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Vice President of Preclinical Development and Product Leadership |
Brenda Sousa
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41 |
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Vice President of Human Resources |
Directors:**
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Christopher F.O. Gabrieli
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46 |
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Chairman of the Board |
Patrick J. Fortune, Ph.D.
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58 |
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Director |
Frederick Frank
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73 |
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Director |
Michael Gilman, Ph.D.
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51 |
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Director |
Michael G. Kauffman, M.D., Ph.D.
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42 |
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Director |
Mark Leuchtenberger
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49 |
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Director |
Gregory D. Phelps
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57 |
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Director |
Ian F. Smith, CPA, ACA
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39 |
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Director |
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** |
In addition, the board of directors of EPIX after the merger is
expected to have an additional member designated by EPIX who has
not yet been identified. |
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Management and Key Employees of EPIX After the
Merger |
Michael G. Kauffman, M.D., Ph.D. has served as
Predixs President and Chief Executive Officer and as a
member of Predixs board of directors since August 2003.
From September 2002 until August 2003, Dr. Kauffman served
as President and Chief Executive Officer of Predix
Pharmaceuticals, Inc., the wholly-owned U.S. subsidiary of
Predix Pharmaceuticals Ltd., an Israeli corporation that Predix
acquired in August 2003. From March 2000 to September 2002,
Dr. Kauffman served as Vice President, Medicine, and
Proteasome Inhibitor (Velcade) Program Leader at Millennium
Pharmaceuticals Inc. Dr. Kauffman held senior positions at
Millennium Predictive Medicine, Inc., as cofounder and Vice
President of Medicine from September 1997 to February 2000. From
September 1995 to September 1997,
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Dr. Kauffman served as Medical Director at Biogen
Corporation (now Biogen Idec). He currently serves on the board
of directors of Bioenvision, Inc., a publicly traded
biopharmaceutical company. Dr. Kauffman received his M.D.
and Ph.D. (Molecular Biology and Biochemistry) at Johns Hopkins
and his postdoctoral training at Harvard University. He received
his B.A. in Biochemistry summa cum laude from Amherst
College and is board certified in Internal Medicine.
Andrew C.G. Uprichard, M.D. joined EPIX as President
and Chief Operating Officer in July 2004. Dr. Uprichard has
an extensive background in discovery research and development in
the biopharmaceutical industry. Prior to joining EPIX,
Dr. Uprichard served as Chief Operating Officer at ArQule,
Inc. from 2002 to 2003 and at Curis, Inc. from 2000 to 2002. For
the preceding 11 years, Dr. Uprichard held numerous
management positions at Parke-Davis/ Warner-Lambert (now part of
Pfizer) in pharmaceutical research, where his
experience spanning drug discovery, pre-clinical and
clinical development included the oversight of a
number of IND filings. From 1997 to 2000, Dr. Uprichard was
Vice President, Drug Development; from 1994 to 1997, the Senior
Director, Cardiovascular Pharmacology; and from 1989 to 1994,
Dr. Uprichard held various oversight positions in
Cardiovascular Clinical Development. In the late 1980s,
Dr. Uprichard was a Cardiology and Postdoctoral Fellow at
the University of Michigan Medical School. Dr. Uprichard
holds M.B., Ch.B. and M.D. degrees from the University of
Edinburgh, Scotland; is a Fellow of the Royal College of
Physicians of Edinburgh; a Fellow of the Faculty of
Pharmaceutical Medicine and a Fellow of the American College of
Physicians.
Kimberlee C. Drapkin, CPA has served as Predixs
Chief Financial Officer since February 2005. From 1995 to
February 2005, Ms. Drapkin held senior positions of
increasing responsibility within the finance organization at
Millennium Pharmaceuticals, Inc. with leadership responsibility
for financial reporting, technical accounting, Sarbanes Oxley
compliance and internal audit. Ms. Drapkin began her
professional career at Price Waterhouse (now
PricewaterhouseCoopers LLP) and is a Certified Public
Accountant. Ms. Drapkin is a graduate of Babson College,
holding a B.S. in Accounting summa cum laude.
Oren Becker, Ph.D. has served as Predixs Chief
Scientific Officer since August 2003. Dr. Becker founded
Predix Pharmaceuticals Ltd. and served as its Chief Technology
Officer and on its board of directors from its inception in
November 2000 through August 2003. Before founding Predix,
Dr. Becker held a position as a visiting professor at
Harvard University from 1999 to 2000 and a professor at Tel-Aviv
University from 1994 to 2000. Dr. Becker received his B.Sc.
in Physics and Chemistry summa cum laude, a B.A. in
Philosophy magna cum laude and a Ph.D. in Theoretical
Chemical Physics from the Hebrew University of Jerusalem and his
postdoctoral training at Harvard University.
Stephen R. Donahue, M.D. has served as Predixs
Vice President, Clinical and Regulatory Affairs since October
2004. From June 2003 to October 2004 he served as the medical
director overseeing clinical research in atherosclerosis and
metabolism at Merck, where he played a key role in securing
regulatory approval of Vytorin (ezetimibe/simvastatin). From
1997 to June 2003, Dr. Donahue held several senior clinical
positions at Bristol-Myers Squibb, in clinical pharmacology,
metabolism and cardiovascular diseases. Dr. Donahue is a
graduate of Georgetown University Medical School and Brown
University. He completed his residency in internal medicine at
Georgetown University Medical Center and is Board Certified in
both Internal Medicine and Clinical Pharmacology.
Philip Graham, Ph.D. joined EPIX in October 1994 as
a scientist after more than 5 years at Eli Lilly and
Company. During his time at EPIX, Dr. Graham had management
responsibility for chemical and analytical development along
with pharmacology and toxicology. He played an important role in
the research and development of Vasovist as well as leading the
thrombus imaging program from lead optimization through the
initiation of Phase II proof-of concept trials with
EP-2104R. Dr. Graham received his Bachelor of Science
(Hons, 1st Class) degree from the University of Otago, New
Zealand, and his Ph.D. in Analytical Chemistry from the
University of Massachusetts, Amherst.
Thomas McMurry, Ph.D. has been part of the
scientific management team at EPIX since it initiated operations
in 1993. Dr. McMurry was promoted to Vice President in
March 2004 and is responsible for discovery and pre-clinical
activities. Prior to joining EPIX, he was a Senior Staff Fellow
in Radiation Oncology at the National Cancer Institute in
Bethesda, Maryland, and a postdoctoral associate at the
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University of California, Berkeley. Dr. McMurry holds a
M.S. and Ph.D. in Organic Chemistry from the University of
Michigan and is a graduate of the Pennsylvania State University.
Dr. McMurry is an author of over 30 scientific publications
and is an inventor of
MS-325 and EP-2104R.
Silvia Noiman, Ph.D. has served as Senior Vice
President of Pipeline Management and General Manager of
Predixs subsidiary in Israel since August 2003.
Dr. Noiman founded Predix Pharmaceuticals Ltd. and served
as its Chief Operating Officer from November 2000 until August
2003. Before founding Predix Pharmaceuticals Ltd.,
Dr. Noiman performed private entrepreneurship activities in
the Biotechnology Industry in Israel from 1998 to 2000.
Dr. Noiman held an academic position at the Weizmann
Institute of Science from 1993 to 1996. Dr. Noiman received
her Ph.D. (Molecular Biology) and MBA at Tel-Aviv University.
Robert Pelletier, CPA joined EPIX in March 2003. He came
to EPIX from The Medicines Company where he was Senior Director
of Finance from July 2000 to March 2003. Prior to July 2000,
Mr. Pelletier spent nine years as Controller and
subsequently Vice President of Finance at AverStar Inc., a
software company that provided engineering and software
services, products/tools and integrated system solutions to
government and commercial customers, and eleven years at
Textron, Inc. in various accounting and finance roles. He holds
a BS in Accounting from the University of Rhode Island, an MBA
from Bentley College and is a Certified Public Accountant.
Chen Schor, CPA has served as Predixs Chief
Business Officer since January 2004. From 1998 to December 2003
Mr. Schor served as Partner, Life Sciences, and Chief
Financial Officer, at Yozma Venture Capital Group. Yozma was one
of the lead investors in Predix Pharmaceuticals Ltd. when the
company was founded in 2000. Mr. Schor served as a member
of the board of directors of Predix Pharmaceuticals Ltd. from
November 2000 to August 2003 and Predix Pharmaceuticals, Inc.
from September 2001 until August 2003. Mr. Schor served as
a member of Predixs board of directors from August 2003
until December 2003. Mr. Schor previously held positions at
Arthur Andersen from 1995 to 1996 and BDO consultants from 1996
to 1998 and holds an MBA, B.A. in Biology, B.A. in Economics and
is a Certified Public Accountant.
Sharon Shacham, Ph.D. has been a member of
Predixs scientific management team since Predix was
founded in 2000. Dr. Shacham joined Predix with its
founders and was the lead scientist in GPCR modeling; her Ph.D.
thesis provided the basis for much of Predixs original and
current computational technology, including in silico
screening protocols and early hit identification. As one of
the original employees of Predix, Dr. Shacham has played a
key role in the discovery and development of Predixs
clinical and pre-clinical drug candidates. In January 2006,
Dr. Shacham was promoted to Vice President of Preclinical
Development and Product Leadership. Prior to joining Predix, she
received a B.Sc. in Chemistry magna cum laude, a Ph.D. in
Biochemistry and Biophysics, and an MBA, from Tel Aviv
University.
Brenda Sousa joined EPIX in June 1998. Ms. Sousa joined
EPIX from RKS Health Ventures and the Spence Center for
Womens Health where she was the Director of Human
Resources from June 1995 to May 1998. Prior to 1998,
Ms. Sousa spent ten years in the hospitality industry with
Hilton, Stouffers and Sonesta hotels in a variety of sales and
marketing positions. She is a member of the board of directors
for a nonprofit organization, Career Collaborative, and is the
Chair of their Employer Advisory Committee. Ms. Sousa holds
an Associates Degree in Psychology.
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Board of Directors of EPIX After the Merger |
Christopher F.O. Gabrieli has been a member of the board
of directors of EPIX since 1994, and he is the Chairman of the
board of directors. Mr. Gabrieli is the Chairman of
Massachusetts 2020, a non-profit public policy organization. He
is a member of the general partners of Bessemer Venture
Partners III L.P. and Bessemer Venture Partners IV
L.P. and related venture capital partnerships, where he worked
from 1986 to 2000. Mr. Gabrieli is a candidate for the
Governor of the Commonwealth of Massachusetts, the general
election for which is scheduled in November 2006.
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Patrick J. Fortune, Ph.D. has served as a member of
Predixs board of directors since January 2005.
Dr. Fortune has been a partner at Boston Millennia Partners
since August 2001. He was previously President and Chief
Operating Officer of New Era of Networks from 1999 to July 2001;
Vice President at Monsanto from 1995 to 1999; Vice President at
Bristol-Myers Squibb from 1991 to 1994; Group President at
Baxter International from 1984 to 1989 and Vice President of
Research and Development at Baxter International from 1982 to
1984. Dr. Fortune currently serves on the board of
directors of Parexel International Corp. and several private
companies. He has served on the engineering and scientific
advisory boards of the University of Wisconsin, the University
of Illinois and the University of Chicago. Dr. Fortune
holds a B.A. from the University of Wisconsin, an MBA from
Northwestern University and a Ph.D. in Physical Chemistry from
the University of Wisconsin.
Frederick Frank joined Predixs board of directors
as chairman in January 2001. Mr. Frank is Vice Chairman and
a Director of Lehman Brothers. Before joining Lehman Brothers as
a Partner in September 1969, Mr. Frank was co-director of
research, as well as Vice President and Director, of Smith,
Barney & Co. Incorporated. He is a Chartered Financial
Analyst, member of The New York Society of Security Analysts and
a past president of the Chemical Processing Industry Analysts.
Mr. Frank is a director of Diagnostic Products Corporation,
Landec Corporation and Pharmaceutical Product Development, Inc.,
all of which are publicly traded companies. He also serves on
the boards of directors of Business Engine, Digital
Arts & Sciences, Inc. and eSoft, Inc. He is Chairman of
the National Genetics Foundation, a director of the Salk
Institute, a member of the Pharmaceutical Executive Magazine
advisory board, a member of the Board of Governors of the
National Center for Genome Resources, Chairman of the Board of
The Irvington Institute for Immunological Research, a member of
the Advisory Board of The Harvard School of Public Health and
also the John Hopkins Bloomberg School of Public Health.
Mr. Frank holds a B.A. from Yale University and an MBA from
Stanford Business School.
Michael Gilman, Ph.D. has been a director of EPIX since
April 2006. Most recently he was Executive Vice President,
Research at Biogen Idec. He joined Biogen in 1999 as Director of
Molecular Biology and became head of research at Biogen in 2000.
Dr. Gilman was Executive Vice President and Chief
Scientific Officer of ARIAD Pharmaceuticals from 1995 to 2000.
Prior to that, Dr. Gilman spent eight years on the
scientific staff of Cold Spring Harbor Laboratory in New York,
where his research focused on mechanisms of signal transduction
and gene regulation. Dr. Gilman holds a Ph.D. in
Biochemistry from University of California, Berkeley, and a S.B.
in Life Sciences from Massachusetts Institute of Technology.
Michael G. Kauffman, M.D., Ph.D. See
Dr. Kauffmans biography set forth under
Management and Key Employees of EPIX After the
Merger above.
Mark Leuchtenberger has been a member of the board of
directors of EPIX since September 2004. Mr. Leuchtenberger
is the President and Chief Executive Officer of Therion
Biologics, a privately held biotechnology company developing
therapeutic vaccines for cancer. Prior to joining Therion in
2002, Mr. Leuchtenberger spent 11 years at Biogen,
Inc., where he led the development and launch of Avonex and ran
North American and international commercial operations. Prior to
Biogen, he was a consultant at Bain & Company
specializing in healthcare. Mr. Leuchtenberger also serves
on boards for the Massachusetts Biotechnology Council, Beth
Israel Deaconess Medical Center and Wake Forest University.
Gregory D. Phelps has been a Director of EPIX since July
2004. Mr. Phelps is the Chairman of the Board and Chief
Executive Officer of RenaMed Biologics, Inc., a biotechnology
company developing therapeutic products. He has previously held
positions of Chief Executive Officer of Ardais Corporation,
Viagene, Inc. and ZymoGenetics, Inc. He has also served as Vice
Chairman of Dyax Corporation, Executive Vice President of
Genzyme Corporation and Vice President of Baxter Travenol
Laboratories, Inc. (now Baxter Healthcare).
Ian F. Smith, CPA, ACA has been a member of Predixs
board of directors since May 2005. Mr. Smith is currently
Senior Vice President and Chief Financial Officer of Vertex
Pharmaceuticals Incorporated. He began as Vice President and
Chief Financial Officer in October 2001, and was promoted to
Senior Vice President and Chief Financial Officer in November
2003. Prior to joining Vertex
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Mr. Smith was a partner in the Life Science and Technology
Practice of Ernst & Young, LLP since 1999. He had
various responsibilities in Ernst & Youngs
accounting, auditing and mergers and acquisitions groups.
Mr. Smith initially joined Ernst & Youngs
U.K. firm in 1987, and then joined its Boston office in 1995.
Mr. Smith holds a B.A. in Accounting and Finance from
Manchester Metropolitan University, U.K., is a member of the
American Institute of Certified Public Accountants and is a
Chartered Accountant of England and Wales.
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Board Composition of EPIX After the Merger |
Upon the closing of the merger, EPIXs board of directors
will be divided into three classes, with each director serving a
three-year term and one class being elected at each years
annual meeting of stockholders. A majority of the members of the
EPIX board of directors after the merger will be independent
within the meaning of the director independence standards of The
NASDAQ National Market and the applicable rules of the
Securities and Exchange Commission. Mr. Gabrieli and
Dr. Fortune will be in the class of directors whose initial
term expires at the 2007 annual meeting of stockholders. Messrs.
Phelps, Frank and Smith will be in the class of directors whose
initial term expires at the 2008 annual meeting of the
stockholders. Mr. Leuchtenberger and Drs. Gilman and
Kauffman will be in the class of directors whose initial term
expires at the 2009 annual meeting of stockholders. This
classification of the EPIX board of directors will make it more
difficult for a third party to acquire control of EPIX after the
merger. In addition, the EPIX board of directors after the
merger will have an additional member designated by EPIX who has
not yet been identified, whose term will expire at the 2007
annual meeting of stockholders.
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Committees of the Board of EPIX After the Merger |
The EPIX board of directors has established three standing
committees: the audit committee, the compensation committee and
the corporate governance and nominating committee. In addition,
after the merger the composition of the committees will change
as a result of the resignation of certain existing EPIX
directors and the election of four Predix directors to the board
of directors of EPIX.
Audit Committee. EPIXs audit committee after the
merger will consist of Ian F. Smith CPA, ACA, Christopher F.O.
Gabrieli and Gregory D. Phelps, each of whom will be independent
within the meaning of the director independence standards of The
NASDAQ National Market and the applicable rules of the
Securities and Exchange Commission. Mr. Smith will serve as
Chairman of EPIXs audit committee after the merger and
also qualify as an audit committee financial expert,
as that term is defined under the recently adopted Securities
and Exchange Commission rules. Each member of EPIXs audit
committee after the merger will meet the then current
independence and financial literacy requirements promulgated by
the Securities and Exchange Commission and by The NASDAQ
National Market. EPIXs audit committee after the merger
will be responsible for preparing such reports, statements or
charters as may be required by The NASDAQ National Market or
federal securities laws, as well as, among other things:
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reviewing the engagement of independent accountants and
retaining and terminating the services of independent
accountants; |
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considering matters relating to accounting policy and internal
controls and reviewing the scope of annual audits; |
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reviewing annual financial statements; |
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preparing the report that Securities and Exchange Commission
rules require be included in its annual proxy statement; |
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overseeing and monitoring its independent registered public
accounting firms qualifications, independence and
performance; |
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providing the EPIX board of directors with the results of its
monitoring and recommendations; and |
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providing to the EPIX board of directors after the merger
additional information and materials as it deems necessary to
make the EPIX board of directors aware of significant financial
matters that require the attention of the EPIX board of
directors. |
Compensation Committee. EPIXs compensation
committee after the merger will be composed of Patrick J.
Fortune, Ph.D., Mark Leuchtenberger and Michael Gilman, Ph.D.,
each of whom will be independent within the meaning of the
director independence standards of The NASDAQ National Market
and the applicable rules of the Securities and Exchange
Commission. Mr. Leuchtenberger will serve as Chairman of
EPIXs compensation committee after the merger. The
compensation committee will be responsible for, among other
things:
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determining the compensation of EPIXs Chief Executive
Officer, (conducting its decision making process with respect to
that issue without the Chief Executive Officer present); |
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formulating, evaluating and approving the compensation of the
EPIX directors, other executive officers and key
employees; and |
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administering EPIXs equity plans. |
Corporate Governance and Nominating Committee.
EPIXs corporate governance and nominating committee after
the merger will be composed of Frederick Frank, Mark
Leuchtenberger and Gregory D. Phelps, each of whom will be
independent within the meaning of the director independence
standards of The NASDAQ National Market and the applicable rules
of the Securities and Exchange Commission. Mr. Phelps will
serve as Chairman of EPIXs corporate governance and
nominating committee after the merger. The corporate governance
and nominating committee will be responsible for, among other
things, making recommendations to the full board of directors of
EPIX as to the size and composition of the EPIX board of
directors and to make recommendations as to particular nominees.
For all potential candidates, the corporate governance and
nominating committee will consider all factors it deems
relevant, such as a candidates personal integrity and
sound judgment, business and professional skills and experience,
independence, knowledge of the industry in which the combined
company operates, possible conflicts of interest, diversity, the
extent to which the candidate would fill a present need on the
EPIX board of directors, and concern for the long-term interests
of EPIXs stockholders. In general, persons recommended by
stockholders will be considered on the same basis as candidates
from other sources. If a stockholder wishes to nominate a
candidate to be considered for election as a director of EPIX,
it must follow the procedures described in EPIXs by-laws.
If a stockholder wishes simply to propose a candidate for
consideration as a nominee by the corporate governance and
nominating committee, it should submit any pertinent information
regarding the candidate to the attention of the Chairman of the
corporate governance and nominating committee, EPIX
Pharmaceuticals, Inc., 161 First Street, Cambridge, MA
02142.
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Compensation Committee Interlocks and Insider
Participation with Respect to EPIX |
Each member of EPIXs compensation committee after the
merger will be an outside director as that term is
defined in Section 162(m) of the Internal Revenue Code of
1986, as amended, and a
non-employee
director within the meaning of
Rule 16b-3 of the
rules promulgated under the Securities Exchange Act
of 1934, as amended. At the effective time of the merger,
it is not expected that any of EPIXs executive officers
will serve as a member of the board of directors or compensation
committee of any entity that has one or more executive officers
who serve on the EPIX board of directors or compensation
committee after the merger.
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Compensation of EPIXs Board of Directors |
EPIX expects to compensate the members of its board of directors
and the committees thereof in accordance with EPIXs
current compensation policies. See Current Management of
EPIX and Related Information Board of Directors of
EPIX.
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CURRENT MANAGEMENT OF EPIX AND RELATED INFORMATION
Board of Directors of EPIX
EPIXs by-laws provide that EPIXs business is to be
managed by or under the direction of the EPIX board of directors
and that the number of members of the EPIX board of directors be
fixed from time to time by the EPIX board of directors. The EPIX
board of directors is divided into three classes for purposes of
election. One class is elected at each annual meeting of
stockholders to serve for a three-year term. The EPIX board of
directors currently consists of five members, classified into
three classes as follows: (a) Gregory D. Phelps
constitutes a class with a term ending at the 2007 annual
meeting; (b) Peter Wirth, Mark Leuchtenberger and Michael
Gilman, Ph.D. constitute a class with a term ending at the
upcoming 2006 annual meeting; and (c) Christopher F.O.
Gabrieli constitutes a class with a term ending at the 2008
annual meeting. Mr. Wirth has notified EPIX that he is not
standing for reelection at the 2006 EPIX annual stockholders
meeting.
The EPIX board of directors voted to nominate each of Mark
Leuchtenberger and Michael Gilman, Ph.D. for election at the
upcoming annual meeting for a term of three years, to serve
until the 2009 annual meeting of stockholders, and until their
successors have been elected and qualified.
Set forth below are the names of the persons nominated as
directors and directors whose terms do not expire this year,
their ages, their offices in the Company, if any, their
principal occupations or employment for the past five years, the
length of their tenure as directors and the names of other
public companies in which such persons hold directorships.
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Name |
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Age | |
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Position with the Company |
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Christopher F.O. Gabrieli
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Chairman of the Board |
Mark Leuchtenberger
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Director |
Gregory D. Phelps
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Director |
Michael Gilman, Ph.D.
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Director |
Christopher F.O. Gabrieli, Chairman of the Board. See
Mr. Gabrielis biography set forth under
Management of EPIX After the Merger Board of
Directors of EPIX After the Merger.
Mark Leuchtenberger. See Mr. Leuchtenbergers
biography set forth under Management of EPIX After the
Merger Board of Directors of EPIX After the
Merger.
Gregory D. Phelps. See Mr. Phelpss biography
set forth under Management of EPIX After the
Merger Board of Directors of EPIX After the
Merger.
Michael Gilman, Ph.D. See Dr. Gilmans
biography set forth under Management of EPIX After the
Merger Board of Directors of EPIX After the
Merger.
The EPIX board of directors has determined that all of the
members of the EPIX board of directors qualify as independent
under the definition promulgated by The NASDAQ National Market.
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Committees of the EPIX Board of Directors and
Meetings |
Meeting Attendance. During the fiscal year ended
December 31, 2005, there were eight meetings of the EPIX
board of directors, and the various committees of the board of
directors met a total of eight times. No director attended fewer
than 75% of the total number of meetings of the board of
directors and the committees of the board of directors on which
he served during the year ended December 31, 2005. The EPIX
board of directors has adopted a policy under which each member
of the EPIX board of directors is encouraged to participate in
the annual meeting of stockholders. No members of the EPIX board
of directors attended the annual meeting of stockholders held in
2005.
Audit Committee. EPIXs audit committee met six
times during the fiscal year ended December 31, 2005. This
committee currently has three members: Peter Wirth (Chairman),
Christopher F.O. Gabrieli
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and Mark Leuchtenberger. The audit committee reviews the
engagement of EPIXs independent accountants and has the
authority to retain and terminate the services of EPIXs
independent accountants, reviews annual financial statements,
considers matters relating to accounting policy and internal
controls and reviews the scope of annual audits. All members of
the audit committee satisfy the current independence standards
promulgated by the Securities and Exchange Commission and by The
NASDAQ National Market; as such standards apply specifically to
audit committees. The EPIX board of directors has determined
that Mr. Leuchtenberger is an audit committee
financial expert, as the Securities and Exchange
Commission has defined that term in Item 401 of
Regulation S-K.
Please also see the report of the audit committee set forth
elsewhere in this joint proxy statement/ prospectus.
Compensation Committee. EPIXs compensation
committee met two times during the year ended December 31,
2005. This committee currently has three members: Christopher
F.O. Gabrieli (Chairman), Mark Leuchtenberger and Gregory D.
Phelps. The compensation committee reviews, approves and makes
recommendations regarding EPIXs compensation policies,
practices and procedures to ensure that the legal and fiduciary
responsibilities of the EPIX board of directors are carried out
and that such policies, practices and procedures contribute to
EPIXs success. The compensation committee is responsible
for the determination of the compensation of EPIXs Chief
Executive Officer, and conducts its decision making process with
respect to that issue without the Chief Executive Officer
present. In addition, the compensation committee is responsible
for formulating, evaluating and approving the compensation of
EPIXs directors, other executive officers and key
employees and is responsible for the administration of
EPIXs equity plans. All members of the compensation
committee qualify as independent under the definition
promulgated by The NASDAQ National Market. Please also see the
report of the compensation committee set forth elsewhere in this
joint proxy statement/ prospectus.
Compensation Committee Interlocks and Insider
Participation. EPIXs compensation committee has three
members: Christopher F.O. Gabrieli (Chairman), Mark
Leuchtenberger and Gregory D. Phelps. There are no interlocking
relationships between members of EPIXs compensation
committee and the compensation committees of other
companies boards of directors.
Nominating and Governance Committee. EPIXs
nominating and governance committee did not meet during the year
ended December 31, 2005. The nominating and governance
committee has two members: Christopher F.O. Gabrieli (Chairman)
and Peter Wirth. This committees role, following
consultation with all other members of the EPIX board of
directors, is to make recommendations to the full board of
directors as to the size and composition of the board of
directors and to make recommendations as to particular nominees.
All members of the nominating and governance committee qualify
as independent under the definition promulgated by The NASDAQ
National Market. The nominating and governance committee may
consider candidates recommended by EPIXs stockholders as
well as from other sources such as other directors and officers,
third party search firms or other appropriate sources. For all
potential candidates, the nominating and governance committee
may consider all factors it deems relevant, such as a
candidates personal integrity and sound judgment, business
and professional skills and experience, independence, knowledge
of the industry in which EPIX operates, possible conflicts of
interest, diversity, the extent to which the candidate would
fill a present need on the EPIX board of directors, and concern
for the long-term interests of EPIXs stockholders. In
general, persons recommended by stockholders will be considered
on the same basis as candidates from other sources. If a
stockholder wishes to nominate a candidate to be considered for
election as a director at the 2007 annual meeting of EPIX
stockholders, it must use the procedures described under
Stockholder Nominations of Director in EPIXs
by-laws. If a stockholder wishes simply to propose a candidate
for consideration as a nominee by the nominating and governance
committee, it should submit any pertinent information regarding
the candidate to the attention of the Chairman of the nominating
and governance committee, EPIX Pharmaceuticals, Inc., 161 First
Street, Cambridge, MA 02142.
A copy of the nominating and governance committees written
charter is publicly available on EPIXs website at
www.epixpharma.com.
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Stockholder Communications to the EPIX Board of
Directors |
Generally, stockholders who have questions or concerns about
EPIX should contact EPIXs Investor Relations Department at
(617) 250-6012. However, any stockholders who wish to
address questions regarding EPIXs business directly with
the board of directors or any individual director should direct
his or her questions to the EPIX board of directors or
appropriate member of the board of directors through EPIXs
third-party service provider, Ethicspoint, Inc., at
www.ethicspoint.com.
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Compensation of EPIX Directors |
EPIX pays each non-employee director who serves on a committee
of the EPIX board of directors an annual fee of $25,000 for
service as a director of EPIX and as a committee member. EPIX
pays each non-employee director who does not also serve on a
committee of the EPIX board of directors an annual fee of
$15,000 for service as a director of EPIX. During 2005, EPIX
paid its outside directors the following fees:
Mr. Gabrieli $25,000,
Mr. Leuchtenberger $22,500,
Mr. Phelps $16,250, and
Mr. Wirth $25,000. Stanley T.
Crooke, M.D., Ph.D., who resigned from the EPIX board
of directors in June 2005, was paid $12,500 in connection with
his service on the EPIX board of directors. In addition,
non-employee directors are eligible to participate in
EPIXs Amended and Restated 1996 Director Stock Option
Plan, or the Director Plan. Upon the appointment, election or
reelection of a non-employee director, such director is
automatically granted an option to
purchase 25,000 shares of EPIX common stock. Such
options become exercisable in equal installments over a
three-year period on each anniversary of the grant, provided
that the optionee is still a director of EPIX at the opening of
business on such applicable date. Commencing with grants made on
or after the annual meeting of stockholders, this initial grant
shall be subject to adjustment if a director receives stock
options upon appointment to the EPIX board of directors between
annual meetings of stockholders to fill a vacancy or newly
elected directorship and any such option shall become
exercisable in equal monthly installments from the date of grant
until the first annual meeting of stockholders at which such
director is nominated for election or reelection. In addition,
each non-employee director is automatically granted an option to
purchase 5,000 shares of EPIX common stock annually
during the years in which such director is not up for reelection
to the EPIX board of directors. Such options become exercisable
in full on the first anniversary date of the grant, provided
that the optionee is still a director of EPIX at the opening of
business on such date. Each option has a term of ten years and
becomes vested in full in the event of a merger (in which EPIX
does not survive) or liquidation of EPIX. The exercise price for
each option is equal to the fair market value of the EPIX common
stock on the date of grant. During fiscal 2005, the following
options were granted under the Director Plan: Mr. Gabrieli
an option for 25,000 shares of EPIX common stock,
Mr. Leuchtenberger an option for 5,000 shares of EPIX
common stock, Mr. Phelps an option for 5,000 shares of
EPIX common stock and Mr. Wirth an option for
5,000 shares of EPIX common stock. An option for
5,000 shares of EPIX common stock was also granted to
Dr. Crooke, which was subsequently cancelled upon his
resignation from the EPIX board of directors. Options granted
during 2005 to Michael D. Webb are reported under
Executive Compensation- Option Grants in EPIXs Last
Fiscal Year.
Executive Officers of EPIX
The following table sets forth certain information regarding
EPIXs executive officers who are not also directors. EPIX
has an employment agreement with Mr. Astrue pursuant to
which he serves as EPIXs Interim Chief Executive Officer.
Dr. Uprichard and Mr. Pelletier serve at the pleasure
of the EPIX board of directors.
|
|
|
|
|
|
|
Name |
|
Age | |
|
Position with the Company |
|
|
| |
|
|
Michael J. Astrue
|
|
|
49 |
|
|
Interim Chief Executive Officer |
Andrew C.G. Uprichard, M.D.
|
|
|
49 |
|
|
President and Chief Operating Officer |
Robert Pelletier, CPA
|
|
|
53 |
|
|
Executive Director of Finance |
Michael J. Astrue, Interim Chief Executive Officer.
Mr. Astrue joined EPIX as the Interim Chief Executive
Officer in September 2005. Mr. Astrue was President and
Chief Executive Officer of
101
Transkaryotic Therapies, Inc. from 2003 to 2004. He brings two
decades of public and private sector experience in the
biotechnology and pharmaceutical industries. He has served as
Chairman of the Massachusetts Biotechnology Council and, before
joining Transkaryotic Therapies, was Vice President, Secretary,
and General Counsel for Biogen, Inc. Mr. Astrue was also a
partner at the law firm of Mintz, Levin, Cohn, Ferris, Glovsky
and Popeo, P.C., held several positions with the
U.S. Department of Health and Human Services, including
General Counsel, and served as Associate Counsel to the
President, where he advised and represented former Presidents
Ronald Reagan and George H.W. Bush. He received a J.D. from
Harvard Law School and a B.A. from Yale University.
Andrew C. G. Uprichard, M.D., President and Chief
Operating Officer. See Dr. Uprichards biography
set forth under Management of EPIX After the
Merger Management and Key Employees of EPIX After
the Merger.
Robert Pelletier, CPA, Executive Director of Finance. See
Mr. Pelletiers biography set forth under
Management of EPIX After the Merger Management
and Key Employees of EPIX After the Merger.
|
|
|
Compensation of EPIX Executives |
|
|
|
Summary Compensation Table |
The following table shows the total compensation paid or accrued
during the past three fiscal years ended December 31 to
(a) EPIXs Interim Chief Executive Officer,
(b) EPIXs former Chief Executive Officer and
(c) EPIXs three next most highly compensated
executive officers who earned more than $100,000 during the year
ended December 31, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Term | |
|
|
|
|
|
|
|
|
Compensation | |
|
|
|
|
|
|
Annual Compensation | |
|
Awards | |
|
|
|
|
|
|
| |
|
Securities | |
|
|
|
|
|
|
|
|
Other Annual | |
|
Underlying | |
|
All Other | |
Name and Principal Position |
|
Year | |
|
Salary | |
|
Bonus(1) | |
|
Compensation | |
|
Options (#) | |
|
Compensation | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Michael J. Astrue(2)
|
|
|
2005 |
|
|
$ |
112,308 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
Interim Chief Executive Office |
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew C.G. Uprichard, M.D.
|
|
|
2005 |
|
|
|
309,872 |
|
|
|
14,002 |
|
|
|
|
|
|
|
52,500 |
|
|
|
2,803 |
(3) |
|
President and |
|
|
2004 |
|
|
|
137,308 |
|
|
|
54,878 |
(4) |
|
|
|
|
|
|
175,000 |
|
|
|
2,677 |
(3) |
|
Chief Operating Officer |
|
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert Pelletier, CPA
|
|
|
2005 |
|
|
|
175,188 |
|
|
|
25,835 |
|
|
|
|
|
|
|
23,281 |
|
|
|
4,591 |
(3) |
|
Executive Director of Finance |
|
|
2004 |
|
|
|
157,961 |
|
|
|
34,609 |
|
|
|
|
|
|
|
7,288 |
|
|
|
4,078 |
(3) |
|
and Principal Accounting |
|
|
2003 |
|
|
|
124,038 |
|
|
|
40,050 |
|
|
|
|
|
|
|
40,000 |
|
|
|
3,539 |
(3) |
|
Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael D. Webb
|
|
|
2005 |
|
|
|
356,517 |
(6) |
|
|
|
|
|
|
|
|
|
|
50,000 |
|
|
|
6,300 |
(5) |
|
Former Chief Executive Officer |
|
|
2004 |
|
|
|
334,286 |
|
|
|
49,125 |
|
|
|
|
|
|
|
62,500 |
|
|
|
8,620 |
(5) |
|
|
|
|
2003 |
|
|
|
313,351 |
|
|
|
137,722 |
|
|
|
|
|
|
|
66,500 |
|
|
|
6,225 |
(5) |
Peyton J. Marshall, Ph.D.(7)
|
|
|
2005 |
|
|
|
129,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,972 |
(3) |
|
Former Senior Vice President |
|
|
2004 |
|
|
|
238,933 |
|
|
|
36,114 |
|
|
|
|
|
|
|
35,625 |
|
|
|
4,883 |
(3) |
|
and Chief Financial Officer |
|
|
2003 |
|
|
|
225,000 |
|
|
|
80,156 |
|
|
|
|
|
|
|
|
|
|
|
3,404 |
(3) |
|
|
(1) |
Bonuses were earned in the year indicated and are generally paid
in the subsequent year. |
|
(2) |
Mr. Astrue intends to resign as Interim Chief Executive Officer
in May 2006. |
|
(3) |
Consists of matching 401(k) contributions. |
|
(4) |
Dr. Uprichard joined EPIX in July 2004 and the bonus
compensation amount includes a $20,000 signing bonus. |
102
|
|
(5) |
Consists of matching 401(k) contributions of $6,300, $6,000 and
$6,000 in 2005, 2004 and 2003, respectively, and life insurance
premiums paid by EPIX on behalf of Mr. Webb on a policy for
the benefit of Mr. Webb of $2,620 in 2004 and $225 in 2003. |
|
(6) |
Effective September 14, 2005, Mr. Webb resigned as
Chief Executive Officer and member of the EPIX board of
directors. This figure represents $254,435 earned by
Mr. Webb as Chief Executive Officer through
September 14, 2005, and $102,082 in fees and expense
reimbursements, paid to Mr. Webb in connection with
consulting services he provided to EPIX from September 14,
2005 through December 31, 2005. |
|
(7) |
Effective July 1, 2005, Mr. Marshall resigned as
Senior Vice President, Finance and Administration and Chief
Financial Officer of EPIX. |
|
|
|
Option Grants in EPIXs Last Fiscal Year |
The following table shows grants of stock options that EPIX made
during the year ended December 31, 2005 to each of the
executive officers named in the Summary Compensation Table,
above.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Individual Grants(1) | |
|
Potential Realizable | |
|
|
| |
|
Value at Assumed | |
|
|
Number of | |
|
% of Total | |
|
|
|
Annual Rates of Stock | |
|
|
Securities | |
|
Options | |
|
Exercise | |
|
|
|
Price Appreciation for | |
|
|
Underlying | |
|
Granted to | |
|
or Base | |
|
|
|
Option Term(2) | |
|
|
Options | |
|
Employees in | |
|
Price | |
|
Expiration | |
|
| |
Name |
|
Granted(1) | |
|
Fiscal Year | |
|
($/Share) | |
|
Date | |
|
5% | |
|
10% | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Michael J. Astrue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew C.G. Uprichard, M.D.
|
|
|
52,500 |
|
|
|
8.83 |
% |
|
$ |
7.15 |
|
|
|
3/17/2015 |
|
|
$ |
236,071 |
|
|
$ |
598,251 |
|
Robert Pelletier, CPA
|
|
|
8,281 |
|
|
|
1.39 |
% |
|
|
7.15 |
|
|
|
3/17/2015 |
|
|
|
37,236 |
|
|
|
94,364 |
|
|
|
|
15,000 |
|
|
|
2.52 |
% |
|
|
8.69 |
|
|
|
6/24/2015 |
|
|
|
81,976 |
|
|
|
207,744 |
|
Michael D. Webb(3)
|
|
|
50,000 |
|
|
|
8.41 |
% |
|
|
7.15 |
|
|
|
3/17/2015 |
|
|
|
224,830 |
|
|
|
569,763 |
|
Peyton J. Marshall, Ph.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
These options were granted under EPIXs Amended and
Restated 1992 Equity Incentive Plan, or the Equity Plan, at an
exercise price equal to the fair market value of EPIX common
stock at the date of grant. All of the options granted vest in
five equal annual installments and began vesting on
March 17, 2006 except for one of the grants to
Mr. Pelletier which begins vesting on June 24, 2006.
With the exception of Mr. Pelletiers option for
8,281, which is an incentive stock option, each of the options
cited above consists of a combination of non-qualified stock
options and incentive stock options as follows:
Dr. Uprichards option consists of 41,992
non-qualified stock options and 10,508 incentive stock options;
Mr. Pelletiers grant of 15,000 options consists of
7,907 non-qualified stock options and 7,093 incentive stock
options, and Mr. Webbs option consists of 39,998
non-qualified options and 10,002 incentive stock options. The
options are not transferable, except by will or by laws of
descent and distribution. The post-termination exercise period
for exercisable options is generally three months. If an
acquisition event also constitutes a change in control, or, if
there is a change in control that does not also constitute an
acquisition event, unless provided to the contrary in an
agreement between EPIX and the optionee, the options or such
assumed or substituted options shall become immediately
exercisable in full, if within eighteen months of the change in
control, a termination event (as defined below) with respect to
the optionee occurs. If the acquiring or succeeding corporation
does not agree to assume or issue substitute options for the
options issued by EPIX, the options issued by EPIX shall become
immediately exercisable in full. If the acquisition event
involves a cash payment to EPIXs stockholders, the
optionee shall receive a cash payment for each option equal to
the amount by which the price to be paid in the acquisition
exceeds the option exercise price. |
|
|
|
An acquisition event means (a) any merger or consolidation
of EPIX with or into another entity as a result of which
EPIXs common stock is converted into or exchanged for the
right to receive cash, securities or other property;
(b) any exchange of EPIX shares for cash, securities or
other property pursuant to a statutory share exchange
transaction; (c) any sale or exchange of all or
substantially all of EPIXs assets in one transaction or in
a series of transactions; or (d) a reorganization or
liquidation of EPIX. |
103
|
|
|
A change in control means either (a) (i) a merger or
consolidation of EPIX, whether or not approved by the EPIX board
of directors, other than a merger or consolidation in which
EPIXs voting securities continue to represent at least 50%
of the total voting power represented by EPIXs voting
securities of the surviving entity outstanding immediately after
the merger or consolidation, or (ii) the approval by
EPIXs stockholders of an agreement for the sale or
disposition by EPIX of all or substantially all of EPIXs
assets; or (b) any person becoming the beneficial owner of
EPIXs securities representing 50% or more of EPIXs
total outstanding voting power (excluding EPIX or EPIXs
affiliates or any EPIX employee benefit plan) pursuant to a
transaction or a series of related transactions which the EPIX
board of directors does not approve. |
|
|
A termination event means the termination of the optionees
employment (a) by EPIX or the acquiring or succeeding
corporation without cause; or (b) by the optionee upon
written notice given promptly after EPIXs or the acquiring
or succeeding corporations taking any of the following
actions, which actions shall not have been cured within a
30-day period following
such notice: (i) the principal place of the performance of
the optionees responsibilities, or the Principal Location,
is changed to a location outside of a 30 mile radius from
the Principal Location immediately prior to the change in
control; (ii) there is a material reduction in the
optionees salary; or (iii) there is a material
diminution in the scope of the optionees responsibilities
without the optionees agreement or without cause. |
|
|
(2) |
In accordance with the rules of the Securities and Exchange
Commission, EPIX shows in these columns the potential realizable
value over the term of the option (the period from the grant
date to the expiration date). EPIX calculates this assuming that
the fair market value of EPIXs common stock on the date of
grant appreciates at the indicated annual rate, 5% and 10%
compounded annually, for the entire term of the option and that
the option is exercised and sold on the last day of its term for
the appreciated stock price. These amounts are based on assumed
rates of appreciation and do not represent an estimate of
EPIXs future stock price. Actual gains, if any, on stock
option exercises will depend on the future performance of
EPIXs common stock, the optionholders continued
employment with EPIX through the option exercise period, and the
date on which the option is exercised. |
|
(3) |
Effective September 14, 2005, Mr. Webb resigned as
Chief Executive Officer and member of the EPIX board of
directors, but continued to provide consulting services to EPIX
through December 31, 2005. In connection with his departure
from EPIX these options have now been cancelled. |
|
|
|
Aggregated Option Exercises in Last Fiscal Year and Fiscal
Year-End Option Values |
The following table shows information regarding exercises of
options to purchase EPIX common stock by each executive officer
named in the Summary Compensation Table during the year ended
December 31, 2005. The table also shows the aggregate value
of options held by each executive officer named in the Summary
Compensation Table as of December 31, 2005. The value of
the unexercised
in-the-money options at
fiscal year end is based on a value of $4.04 per share, the
closing price of EPIXs common stock on The NASDAQ National
Market on December 31, 2005 (the last trading day prior to
the fiscal year end), less the per share exercise price.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
Value of the Unexercised |
|
|
|
|
|
|
Underlying Unexercised | |
|
In-The-Money Options at |
|
|
Shares | |
|
|
|
Options at Fiscal Year-End | |
|
Fiscal Year-End |
|
|
Acquired on | |
|
Value | |
|
| |
|
|
Name |
|
Exercise | |
|
Realized(1) | |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable |
|
Unexercisable |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
Michael J. Astrue
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Andrew C.G. Uprichard, M.D.
|
|
|
|
|
|
|
|
|
|
|
35,000 |
|
|
|
192,500 |
|
|
|
|
|
|
|
|
|
Robert Pelletier, CPA
|
|
|
|
|
|
|
|
|
|
|
9,457 |
|
|
|
53,112 |
|
|
|
|
|
|
|
|
|
Michael D. Webb
|
|
|
30,000 |
|
|
|
66,600 |
|
|
|
467,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Peyton J. Marshall, Ph.D.
|
|
|
20,500 |
|
|
|
52,682 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Amounts shown in this column do not necessarily represent actual
value realized from the sale of the shares acquired upon
exercise of the option because in many cases the shares are not
sold on exercise |
104
|
|
|
but continue to be held by the executive officer exercising the
option. The amounts shown represent the difference between the
option exercise price and the market price on the date of
exercise, which is the amount that would have been realized if
the shares had been sold immediately upon exercise. |
Equity Compensation Plan Information
The following table provides certain aggregate information with
respect to all of EPIXs equity compensation plans in
effect as of December 31, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
|
|
|
|
|
Remaining Available for | |
|
|
|
|
|
|
Future Issuance Under | |
|
|
Number of Securities to | |
|
|
|
Equity Compensation Plans | |
|
|
be Issued Upon | |
|
Weighted-Average Exercise | |
|
(Excluding Securities | |
|
|
Exercise of Outstanding | |
|
Price of Outstanding | |
|
Reflected in the First | |
Plan category |
|
Options | |
|
Options | |
|
Column) | |
|
|
| |
|
| |
|
| |
Equity Compensation Plans Approved by Securityholders(1)
|
|
|
3,271,909 |
|
|
$ |
11.39 |
|
|
|
1,519,165 |
(2)(3)(4)(5) |
Equity Compensation Plans not Approved by Securityholders
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
Total
|
|
|
3,271,909 |
|
|
$ |
11.39 |
|
|
|
1,519,165 |
|
|
|
(1) |
These plans consist of EPIXs Amended and Restated 1992
Equity Incentive Plan, or the Equity Plan, the Amended and
Restated 1996 Director Stock Option Plan, or the Director
Plan, and the Amended and Restated 1996 Employee Stock Purchase
Plan, or the Employee Plan. |
|
(2) |
Includes options to purchase 1,032,521 shares of EPIX
common stock issued under the Equity Plan that were cancelled
after December 31, 2005. |
|
(3) |
Does not include options to purchase 300,562 shares of
EPIX common stock issued under the Equity Plan that were granted
to employees after December 31, 2005. |
|
(4) |
Includes options to purchase 53,334 shares of EPIX
common stock issued under the Director Plan that were cancelled
after December 31, 2005. |
|
(5) |
Does not include 149,916 shares of EPIX common stock issued
to date under the Employee Plan. Shares of EPIX common stock
that are set aside within the Employee Plan immediately become
outstanding EPIX common stock when purchased by employees. |
Employment and Severance Agreements
On September 21, 2005, EPIX entered into an employment
agreement, or the Employment Agreement, with Michael J. Astrue,
as amended on March 7, 2006, pursuant to which he is
serving as EPIXs Interim Chief Executive Officer for a
term that will expire on May 31, 2006. Mr. Astrue
intends to resign as Interim Chief Executive Officer in May
2006. Under the terms of the Employment Agreement,
Mr. Astrue receives a salary at the annual rate of
$400,000, paid in accordance with EPIXs usual payroll
practices. Mr. Astrue is also entitled to participate in
employee benefits offered by EPIX to its other senior management
employees and reimbursement of reasonable expenses incurred in
promoting EPIXs business. The Employment Agreement allows
Mr. Astrue to devote reasonable time to certain outside
activities, as set forth in the Employment Agreement, provided
such activities do not conflict in any material way with
EPIXs business. By the terms of the Employment Agreement
and contemporaneous with its execution, EPIX and Mr. Astrue
entered into EPIXs standard indemnification agreement.
EPIX has also agreed to maintain, at a reasonable cost,
directors and officers liability insurance that will cover
Mr. Astrue to the same extent as other senior management
employees of EPIX. The Employment Agreement also contains
confidentiality and assignment of inventions provisions. Either
EPIX or Mr. Astrue may terminate the Employment Agreement
upon ten days prior written notice. In the event the
Employment Agreement is terminated for any reason, EPIX shall
pay Mr. Astrue his salary for the
105
period ending on the last day Mr. Astrue is employed with
EPIX, and shall also provide any other payments or benefits
provided under employee benefit plans or arrangements to the
extent then due from EPIX. In addition, in the event
Mr. Astrue is terminated, the EPIX board of directors may,
in its sole discretion, grant Mr. Astrue a bonus for
services rendered to EPIX.
On September 14, 2005, EPIX entered into a severance and
incentive agreement, or the Severance Agreement, with Andrew
C.G. Uprichard, M.D. Pursuant to the Severance Agreement,
if Dr. Uprichard is terminated without cause or resigns
under certain circumstances involving a change in title, a
diminution of duties, or a material reduction in salary, then,
in exchange for a complete release of all claims against EPIX,
EPIX will pay Dr. Uprichard severance of one years
salary, paid in accordance with EPIXs usual payroll
practices, and will pay the costs to continue his medical and
dental insurance pursuant to COBRA for one year following the
termination date. The Severance Agreement will not apply in the
event of a termination following a change in control, in which
case, Dr. Uprichard may be eligible for severance pay in
accordance with the severance arrangements with executive
officers and certain other senior managers authorized by the
EPIX board of directors in 2003 and further described below.
In connection with Michael D. Webbs resignation as Chief
Executive Officer and member of the board of directors of EPIX,
effective September 14, 2005, EPIX entered into a
separation agreement, or the Separation Agreement, with
Mr. Webb, pursuant to which Mr. Webb continued to
serve as a consultant to EPIX until December 31, 2005 on an
independent contractor basis. Pursuant to the Separation
Agreement, beginning in January 2006, Mr. Webb is entitled
to receive severance pay in the amount of $175,150.50, payable
in six approximately equal monthly payments. EPIX has also
agreed to cover the cost of the COBRA payments to continue
Mr. Webbs participation in its medical and dental
insurance plans during the period in which these severance
payments are made. Under the terms of the Separation Agreement,
Mr. Webbs options vested until September 14,
2005 and he had the right to exercise any vested incentive stock
options in accordance with the terms of the stock option awards
and the plan pursuant to which they were granted and to exercise
any vested nonqualified stock options up through and including
the 90th day following the conclusion of his consulting
work for EPIX.
EPIXs board of directors has authorized a severance
arrangement for its executive officers and selected other senior
managers, under which each such officer or manager who is
subject to a termination event following a change in control of
EPIX (as defined in footnote 1 to the table under
Option Grants in EPIXs Last Fiscal Year) will
receive a cash payment of six months base salary, plus one
additional month of base salary for each year of employment with
EPIX, up to a maximum potential payment of twelve months
base salary. In addition, as set forth in footnote 1 to the
table under Option Grants in EPIXs Last Fiscal
Year, options held by EPIXs executive officers
contain provisions for acceleration of vesting under certain
circumstances in the event of a change in control of EPIX.
106
Performance Graph
The following graph compares the annual percentage change in
EPIXs cumulative total stockholder return on EPIX common
stock during a period commencing on December 31, 2000 and
ending on December 31, 2005 (as measured by dividing
(a) the sum of the cumulative amount of dividends for the
measurement period, assuming dividend reinvestment, and the
difference between the EPIX share price at the end and the
beginning of the measurement period; by (b) the EPIX share
price at the beginning of the measurement period) with the
cumulative total return of The NASDAQ Stock Market Index (U.S.)
and The NASDAQ Pharmaceutical Stock Index during such period.
EPIX has not paid any dividends on its common stock, and EPIX
does not include dividends in the representation of its
performance. The stock price performance on the graph below does
not necessarily indicate future price performance. Information
used on the graph was obtained from Hemscott, Inc., a source
believed to be reliable, but EPIX is not responsible for any
errors or omissions in such information.
COMPARISON OF CUMULATIVE TOTAL RETURN OF ONE OR MORE
COMPANIES, PEER GROUPS, INDUSTRY INDEXES AND/ OR BROAD
MARKETS
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Fiscal Year Ending | |
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Company/Index/Market |
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12/29/2000 |
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12/31/2001 |
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12/31/2002 |
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12/31/2003 |
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12/31/2004 |
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12/30/2005 |
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EPIX Pharmaceuticals, Inc.
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$ |
100.00 |
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$ |
170.63 |
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$ |
86.33 |
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$ |
194.39 |
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$ |
213.85 |
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$ |
48.24 |
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NASDAQ Pharmaceuticals
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100.00 |
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84.95 |
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52.36 |
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75.53 |
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81.63 |
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90.02 |
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NASDAQ US Only
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100.00 |
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77.19 |
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54.01 |
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82.10 |
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89.52 |
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92.74 |
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107
Report of the Compensation Committee of the EPIX Board of
Directors on Executive Compensation
This report is submitted by the compensation committee of the
EPIX board of directors, which is responsible for establishing
and administering EPIXs executive compensation policies
and stock option plans. The compensation committees role
and responsibilities are set forth in the compensation
committees charter adopted by the EPIX board of directors.
At December 31, 2005, the compensation committee was
composed of Christopher F.O. Gabrieli (Chairman), Mark
Leuchtenberger and Gregory D. Phelps, who are each independent,
non-employee directors. This report addresses the compensation
policies for the year ended December 31, 2005 as they
affected Michael D. Webb, in his capacity as Chief Executive
Officer through September 14, 2005, Michael J. Astrue, in
his capacity as Interim Chief Executive Officer beginning on
September 14, 2005, and EPIXs other executive
officers included in the Summary Compensation Table. EPIXs
compensation programs are designed to provide a competitive
level of total compensation, which, at EPIXs present stage
of development, is heavily weighted toward equity incentive
compensation linked to EPIXs performance. This program
includes base salary and both annual and long-term incentive
compensation.
The design and implementation of EPIXs executive
compensation programs are based on a series of guiding
principles derived from EPIXs values, business strategy
and management requirements. These principles may be summarized
as follows:
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|
attract, motivate and retain high caliber individuals who are
responsible for leading EPIX in achieving or exceeding business
and corporate goals and to increase total return to stockholders; |
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provide a total compensation program where a significant portion
of compensation is linked to both short-term and long-term
corporate performance and the achievement of individual
performance objectives; |
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|
align the financial interests of the management team with
EPIXs financial interests and those of its stockholders;
and |
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|
emphasize reward for performance at the individual, team and
corporate levels. |
Each fiscal year, the compensation committee establishes base
salaries for individual executive officers based upon
(a) industry and peer group surveys prepared by independent
consultants, (b) the responsibilities, scope and complexity
of each position, (c) the individuals tenure in the
position and (d) performance judgments as to each
individuals past and expected future contributions. The
performance of the companies surveyed is not considered by the
compensation committee. The Chief Executive Officer recommends
the base salary amount for each officer other than himself. The
compensation committee then reviews with the Chief Executive
Officer and approves, with appropriate modifications, an annual
base salary plan for EPIXs executive officers other than
the Chief Executive Officer.
In general, the compensation committee reviews and fixes the
base salary of the Chief Executive Officer based on comparable
competitive compensation data as well as the compensation
committees assessment of such officers past
performance and its expectations as to such officers
future contributions to EPIXs leadership. For 2005, the
base salary of Mr. Webb, EPIXs Chief Executive
Officer through September 14, 2005, was increased to
$350,301 from $336,828. In connection with Mr. Webbs
departure, Mr. Astrue was appointed Interim Chief Executive
Officer, effective September 14, 2005, pursuant to an
employment agreement providing for a base annual salary of
$400,000.
Beginning in 1998, EPIX started a formal short-term incentive
plan. EPIXs executive officers are eligible for an annual
cash bonus, which is based primarily on corporate achievements
and individual performance objectives that are established at
the beginning of each year. The targeted bonus level for the
Chief Executive Officer is 35% of annual salary. After the
completion of the year, the compensation
108
committee reviews the attainment of corporate and individual
objectives and awards bonuses in the first quarter of the
subsequent year, based on the extent to which corporate
objectives were met or exceeded and individual contributions to
the EPIXs overall performance.
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Equity-Based Long-Term Incentive Compensation |
Long-term incentives for EPIXs employees are provided
through stock option grants under EPIXs Amended and
Restated 1992 Equity Incentive Plan, or the Equity Plan, which
are generally provided through initial stock option grants at
the date of hire, and periodic additional grants. The option
grants are intended to motivate the executive officers to
improve EPIXs long-term performance and to align the
financial interests of the management team with EPIXs
financial interests and those of EPIXs stockholders.
Awards take into account each officers scope of
responsibility and specific assignments, strategic and
operational goals applicable to the officer, anticipated
performance and contributions of the officer and competitive
market data for similar positions. Options are granted with an
exercise price equal to the fair market value of EPIXs
common stock on the date of grant. The standard vesting schedule
provides that a portion of the shares subject to each option
vest and become exercisable annually over a five-year period. In
2005, Mr. Webb received an option to
purchase 50,000 shares of EPIXs common stock,
which in connection with his departure from EPIX, have been
cancelled. Mr. Astrue has not received any options to
purchase EPIX common stock.
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|
|
Compliance with Internal Revenue Code
Section 162(m) |
Section 162(m) of the Internal Revenue Code of 1986, as
amended, or the Code, disallows a tax deduction to public
companies for certain compensation in excess of
$1.0 million paid to each of EPIXs Chief Executive
Officer and its other most highly compensated executive
officers. EPIX does not believe that Section 162(m) will
generally have an effect on it because of the current and
anticipated compensation levels of its executive officers and
Chief Executive Officer. However, the compensation committee
intends to periodically review the potential consequences of
Section 162(m) and may structure the annual cash incentive
awards under EPIXs annual incentive plan to comply with
certain exemptions provided in Section 162(m) for certain
performance-based compensation. EPIXs Equity Plan is
currently structured to comply with such exemptions so that
stock options and other awards under such plan to its executive
officers will be tax deductible under Section 162(m).
The compensation committee reserves the authority to award
non-deductible compensation in other circumstances as it deems
appropriate. Further, because of ambiguities and uncertainties
as to the application and interpretation of Section 162(m)
and the regulations issued thereunder, notwithstanding
EPIXs efforts, compensation intended by EPIX to satisfy
the requirements for deductibility under Section 162(m) may
not, in fact, do so.
|
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|
Members of the EPIX Compensation Committee: |
|
|
CHRISTOPHER F.O. GABRIELI (CHAIRMAN) |
|
MARK LEUCHTENBERGER |
|
GREGORY D. PHELPS |
109
Report of the Audit Committee of the EPIX Board of
Directors
The audit committee of the EPIX board of directors, which
consists entirely of directors who meet the independence and
experience requirements of The NASDAQ National Market, has
furnished the following report:
The audit committee assists the EPIX board of directors in
overseeing and monitoring the integrity of EPIXs financial
reporting process, compliance with legal and regulatory
requirements and the quality of internal and external audit
processes. The audit committees role and responsibilities
are set forth in the audit committees charter adopted by
the EPIX board of directors, which was included in EPIXs
proxy statement for the 2004 Annual Meeting as Appendix A.
The audit committee reviews and reassesses its charter annually
and recommends any changes to the EPIX board of directors for
approval. The audit committee is responsible for overseeing
EPIXs overall financial reporting process. In fulfilling
its responsibilities for the financial statements for the fiscal
year ended December 31, 2005, the audit committee took the
following actions:
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Reviewed and discussed the audited financial statements and the
effectiveness of internal controls on financial reporting for
the year ended December 31, 2005 with management and
Ernst & Young LLP, EPIXs independent auditors; |
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|
Discussed with Ernst & Young LLP the matters required
to be discussed by Statement on Auditing Standards No. 61
relating to the conduct of the audit; and |
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Received written disclosures and the letter from
Ernst & Young LLP regarding its independence as
required by Independence Standards Board Standard No. 1.
The audit committee further discussed with Ernst &
Young LLP their independence. The audit committee also
considered the status of pending litigation, taxation matters
and other areas of oversight relating to the financial reporting
and audit process that the committee determined appropriate. |
Based on the audit committees review of the audited
financial statements and discussions with management and
Ernst & Young LLP, the audit committee recommended to
the EPIX board of directors that the audited financial
statements be included in EPIXs Annual Report on
Form 10-K for the
year ended December 31, 2005 for filing with the Securities
and Exchange Commission.
|
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|
Members of the EPIX Audit Committee: |
|
|
PETER WIRTH (CHAIRMAN) |
|
CHRISTOPHER F.O. GABRIELI |
|
MARK LEUCHTENBERGER |
110
Section 16(a) Beneficial Ownership Reporting
Compliance
EPIXs records reflect that all reports which were required
to be filed pursuant to Section 16(a) of the Securities
Exchange Act of 1934, as amended, in 2005 were filed on a timely
basis.
Certain Relationships and Related Transactions
EPIX has an employment agreement with Michael J. Astrue
which is described under Current Management of EPIX and
Related Information Employment and Severance
Agreements.
In 2005, EPIX engaged Michael Gilman, Ph.D., a member of the
EPIX board of directors, to serve as a consultant in connection
with the evaluation of the merger. Pursuant to the terms of
Dr. Gilmans consulting agreement, EPIX paid
Dr. Gilman approximately $22,950 in 2005 for his services
and has paid him an additional $24,920 as of March 31,
2006. Upon completion of Dr. Gilmans remaining
consulting services in connection with the merger, his
relationship with EPIX as a consultant will end.
In connection with Michael D. Webbs resignation as Chief
Executive Officer and member of the EPIX board of directors,
effective September 14, 2005, EPIX entered into a
separation agreement with Mr. Webb. Pursuant to this
agreement Mr. Webb served as a consultant to EPIX until
December 31, 2005 on an independent contractor basis and is
entitled to receive severance pay in the amount of $175,150.50,
payable in six approximately equal monthly payments. In fiscal
year 2005, EPIX paid Mr. Webb $102,082 for his fees and
expenses in connection with this consultancy.
Code of Conduct and Ethics
EPIX has adopted a code of conduct and ethics that applies to
all of its employees, including its Chief Executive Officer and
Chief Financial and Accounting Officer. The text of the code of
conduct and ethics is posted on EPIXs website at
www.epixpharma.com. Disclosure regarding any amendments to, or
waivers from, provisions of the code of conduct and ethics that
apply to EPIXs directors, Principal Executive and
Financial Officers will be included in a Current Report on
Form 8-K within
four business days following the date of the amendment or
waiver, unless website posting of such amendments or waivers is
then permitted by the rules of The NASDAQ National Market.
111
CURRENT MANAGEMENT OF PREDIX AND RELATED INFORMATION
Compensation of Predix Directors
Currently, non-employee directors of Predix who are not
affiliated with any principal stockholder receive a fee of
$10,000 per year, payable quarterly, as compensation for
service on the Predix board of directors and its committees. The
Chairman of the Predix board of directors currently receives
$30,000 per year, payable quarterly. In addition, each such
director receives $1,250 for each board or committee meeting
attended in person and $500 for each such meeting attended via
teleconference. All of Predixs directors are also eligible
to receive stock and option grants under Predixs 2003
Stock Incentive Plan.
Since January 1, 2005, Predixs non-employee directors
have received the following compensation for service on
Predixs board of directors and committees thereof:
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Director |
|
Cash | |
|
Stock Options(1) | |
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| |
|
| |
Frederick Frank
|
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$ |
37,500 |
|
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Julian Adams, Ph.D.
|
|
$ |
12,500 |
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3,666 |
(2) |
David Collier, M.D.
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1,890 |
(3) |
Yigal Erlich
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Patrick J. Fortune, Ph.D.
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1,890 |
(3) |
Ted Love, M.D.
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$ |
15,000 |
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3,666 |
(2) |
Joel Martin, Ph.D.
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1,890 |
(3) |
Jonathan Silverstein
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Ian F. Smith, CPA, ACA
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$ |
10,084 |
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5,555 |
(4) |
|
|
(1) |
All options vested immediately upon grant and have a term of ten
years. In the event that the director ceases to serve as a
director, the stock option will terminate on the later of
30 days after the recipient ceases to serve as a director
or August 8, 2007, except (a) in the case of death or
disability, in which event the option will terminate one year
from the date of the directors death or disability or
(b) in the event that the non-employee director is
terminated for cause, in which event the option will terminate
immediately. |
|
(2) |
Options were granted on April 28, 2005 at an exercise price
of $0.81 per share. |
|
(3) |
Options were granted on April 26, 2005 at an exercise price
of $0.81 per share. |
|
(4) |
Options were granted on May 10, 2005 at an exercise price
of $0.81 per share. |
112
Compensation of Predixs Executives
|
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|
Summary Compensation Table |
The following summary compensation table sets forth summary
information as to compensation received by
(i) Predixs President and Chief Executive Officer,
(ii) Predixs four other most highly compensated
executive officers who were employed by Predix as of
December 31, 2005 and earned more than $100,000 in salary
and bonus for the year ended December 31, 2005 and are
expected to remain executive officers of the combined company
and (iii) an executive officer who meets the foregoing
requirements of clause (ii) but who is not expected to be
an executive officer of the combined company.
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Long Term | |
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Compensation | |
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Awards: | |
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Securities | |
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Underlying | |
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All Other | |
Name and Principal Position |
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Year | |
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Salary | |
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Bonus | |
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Options (#) | |
|
Compensation(1) | |
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| |
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| |
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| |
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| |
Michael G. Kauffman, M.D., Ph.D.
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2005 |
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$ |
320,000 |
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$ |
130,000 |
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337,227 |
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President and Chief Executive Officer |
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Chen Schor, CPA
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2005 |
|
|
$ |
234,999 |
|
|
$ |
55,000 |
|
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|
132,091 |
|
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Chief Business Officer |
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Silvia Noiman, Ph.D.(2)
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2005 |
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|
$ |
166,846 |
|
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$ |
50,000 |
|
|
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103,106 |
|
|
$ |
71,324 |
|
|
Senior Vice President of Pipeline Management, General Manager
Israel |
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Oren Becker, Ph.D.(2)
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2005 |
|
|
$ |
166,554 |
|
|
$ |
50,000 |
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|
|
97,377 |
|
|
$ |
71,126 |
|
|
Chief Scientific Officer |
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Kimberlee C. Drapkin, CPA(3)
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2005 |
|
|
$ |
146,320 |
|
|
$ |
50,000 |
|
|
|
144,996 |
|
|
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Chief Financial Officer |
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Stephen R. Donahue, M.D.(4)
|
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2005 |
|
|
$ |
252,500 |
|
|
$ |
30,000 |
|
|
|
60,222 |
|
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$ |
33,238 |
|
|
Vice President of Clinical and Regulatory Affairs |
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(1) |
Excludes medical, group life insurance and certain other
benefits received by the named executive officers that are
available generally to all Predixs salaried employees and
certain perquisites and other personal benefits received by the
named executive officers which do not exceed the lesser of
$50,000 or 10% of any such named executive officers total
annual compensation reported in this table. |
|
(2) |
Drs. Noiman and Becker are employed through Predixs
subsidiary, Predix Pharmaceuticals, Ltd. and are paid in Israeli
shekels. Dollar amounts used in this table are based upon the
exchange rate on December 30, 2005. All Other Compensation
for Dr. Noiman represents a car allowance of $12,330 and
Israeli social benefits of $58,994. All Other Compensation for
Dr. Becker represents a car allowance of $13,367 and
Israeli social benefits of $57,759. |
|
(3) |
Ms. Drapkin joined Predix on February 22, 2005. |
|
(4) |
Upon consummation of the merger, Dr. Donahue will remain
the Vice President of Clinical and Regulatory Affairs of the
combined company, but will no longer be deemed an executive
officer of the combined company. All Other Compensation for
Dr. Donahue represents reimbursement for relocation
expenses. |
113
The following table provides information concerning stock option
grants to each of our named executive officers during the year
ended December 31, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Grants in Last Fiscal Year | |
|
|
|
|
| |
|
Potential Realizable | |
|
|
|
|
% of Total | |
|
|
|
Value at Assumed | |
|
|
Number of | |
|
Options | |
|
|
|
Rated of Stock Price | |
|
|
Securities | |
|
Granted to | |
|
|
|
Appreciation for | |
|
|
Underlying | |
|
Employees | |
|
Exercise | |
|
|
|
Option Term(1) | |
|
|
Options | |
|
in Fiscal | |
|
Price | |
|
|
|
| |
Name |
|
Granted | |
|
Year | |
|
per Year | |
|
Expiration Date | |
|
5% ($) | |
|
10% ($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Michael G. Kauffman, M.D., Ph.D.
|
|
|
253,689 |
|
|
|
20.7 |
|
|
$ |
0.810 |
|
|
|
1/18/2015 |
|
|
|
129,457 |
|
|
|
326,726 |
|
|
|
|
83,538 |
|
|
|
6.8 |
|
|
|
1.440 |
|
|
|
4/28/2015 |
|
|
|
565,987 |
|
|
|
970,177 |
|
Chen Schor, CPA
|
|
|
115,043 |
|
|
|
9.4 |
|
|
|
0.810 |
|
|
|
1/18/2015 |
|
|
|
58,706 |
|
|
|
148,164 |
|
|
|
|
35,294 |
|
|
|
2.9 |
|
|
|
1.440 |
|
|
|
4/28/2015 |
|
|
|
232,009 |
|
|
|
409,890 |
|
Silvia Noiman, Ph.D.
|
|
|
89,628 |
|
|
|
7.3 |
|
|
|
0.810 |
|
|
|
1/18/2015 |
|
|
|
45,737 |
|
|
|
115,431 |
|
|
|
|
13,478 |
|
|
|
1.1 |
|
|
|
1.440 |
|
|
|
4/28/2015 |
|
|
|
91,316 |
|
|
|
156,528 |
|
Oren Becker, Ph.D.
|
|
|
84,133 |
|
|
|
6.9 |
|
|
|
0.810 |
|
|
|
1/18/2015 |
|
|
|
42,933 |
|
|
|
108,355 |
|
|
|
|
13,244 |
|
|
|
1.1 |
|
|
|
1.440 |
|
|
|
4/28/2015 |
|
|
|
89,731 |
|
|
|
153,811 |
|
Kimberlee C. Drapkin, CPA
|
|
|
98,445 |
|
|
|
8.0 |
|
|
|
0.810 |
|
|
|
3/18/2015 |
|
|
|
50,236 |
|
|
|
126,787 |
|
|
|
|
46,551 |
|
|
|
3.8 |
|
|
|
1.440 |
|
|
|
4/28/2015 |
|
|
|
315,392 |
|
|
|
540,625 |
|
Stephen R. Donahue, M.D.
|
|
|
36,277 |
|
|
|
3.0 |
|
|
|
0.810 |
|
|
|
3/18/2015 |
|
|
|
18,501 |
|
|
|
46,721 |
|
|
|
|
23,945 |
|
|
|
2.0 |
|
|
|
1.440 |
|
|
|
4/28/2015 |
|
|
|
162,232 |
|
|
|
278,088 |
|
|
|
(1) |
There is no established trading market for Predix shares. The
option grants listed above were made under the Predix 2003 Stock
Incentive Plan at exercise prices equal to the fair market value
of Predix common stock at the date of grant, as determined by
the Predix board of directors. The potential realizable value,
if applicable, is calculated based on the term of the option at
its time of grant. The potential realizable value assumes the
fair market price of option grants was $0.810 on
January 18, 2005 and was $5.04 on March 18, 2005 and
April 28, 2005, which is the fair market value subsequently
assessed for such stock option grants for accounting purposes to
determine compensation expense reportable under Accounting
Principles Board Opinion No. 25. These numbers are
calculated based on Securities and Exchange Commission
requirements and do not reflect Predixs projection or
estimate of future stock price growth. |
|
|
|
Aggregate Option Exercises in 2005 and Values at
December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
|
|
|
|
|
Underlying Unexercised | |
|
Value of Unexercised in the | |
|
|
|
|
Options at December 31, | |
|
Money Options at December 31, | |
|
|
Shares | |
|
2005 | |
|
2005(1) | |
|
|
Acquired on | |
|
| |
|
| |
Name |
|
Exercise | |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable ($) | |
|
Unexercisable ($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Michael G. Kauffman, M.D., Ph.D.
|
|
|
148,829 |
|
|
|
284,346 |
|
|
|
310,333 |
|
|
|
1,434,241 |
|
|
|
1,565,320 |
|
Chen Schor, CPA
|
|
|
83,392 |
|
|
|
57,496 |
|
|
|
193,717 |
|
|
|
290,010 |
|
|
|
977,109 |
|
Silvia Noiman, Ph.D.
|
|
|
0 |
|
|
|
194,822 |
|
|
|
83,274 |
|
|
|
982,682 |
|
|
|
420,034 |
|
Oren Becker, Ph.D.
|
|
|
0 |
|
|
|
183,116 |
|
|
|
78,251 |
|
|
|
923,637 |
|
|
|
394,698 |
|
Kimberlee C. Drapkin, CPA
|
|
|
0 |
|
|
|
34,419 |
|
|
|
110,557 |
|
|
|
173,609 |
|
|
|
557,650 |
|
Stephen R. Donahue, M.D.
|
|
|
0 |
|
|
|
33,260 |
|
|
|
87,569 |
|
|
|
167,763 |
|
|
|
441,696 |
|
|
|
(1) |
There is no established trading market for Predix shares.
Determined by multiplying the product of EPIXs price per
share on December 30, 2005 ($4.04) and the exchange ratio
of 1.248509 by the number of shares exercisable and not
exercisable on December 31, 2005. |
114
Employment Agreements
Pursuant to an employment agreement dated as of August 8,
2003 between Predix and Michael G.
Kauffman, M.D., Ph.D., Predix employs
Dr. Kauffman as its President and Chief Executive Officer
on an at-will basis. Under this agreement,
Dr. Kauffmans base salary is subject to review and
adjustment annually or at such other times as Predix determines.
However, Predix cannot decrease Dr. Kauffmans base
salary unless the base salary of all of Predixs similarly
situated executives is decreased. Dr. Kauffman is also
eligible to receive performance-based bonuses, the timing and
amount of which are at Predixs discretion. Pursuant to the
agreement, Predix granted Dr. Kauffman 59 shares of
Predix common stock, with a fair market value of $1.80 per
share, at no cost to Dr. Kauffman, an option to
purchase 23,976 shares of Predix common stock at an
exercise price of $1.80 per share, which vests as to 25% of
the shares on each of September 23, 2003,
September 23, 2004, September 23, 2005 and
September 23, 2006, and an option to
purchase 18,080 shares of Predix common stock at an
exercise price of $1.80 per share, which vests as to 25% of
the shares on each of July 31, 2004, July 31, 2005,
July 31, 2006 and July 31, 2007. In the event Predix
terminates Dr. Kauffmans employment without cause, as
defined in the agreement, Dr. Kauffman is entitled to
receive his then-current base salary for a period of six months.
Under the agreement, Dr. Kauffman has agreed not to compete
with Predix for a period of six months after the termination of
his employment and not to solicit Predixs customers or
employees or interfere with any of its business relationships
for a period of 12 months after the termination of his
employment. The agreement also contains provisions relating to
the protection of Predixs confidential information and the
assignment of inventions.
Pursuant to an employment agreement dated as of
November 23, 2003 between Predix and Chen Schor, CPA,
Predix employs Mr. Schor as its Chief Business Officer on
an at-will basis. Under this agreement, Mr. Schors
base salary is subject to review and adjustment annually or at
such other times as Predix determines. However, Predix cannot
decrease Mr. Schors base salary unless the base
salary of all of Predixs similarly situated executives is
decreased. Under the agreement, Predix paid Mr. Schor a
signing bonus of $20,000 and he is also eligible to receive
performance-based bonuses, the timing and amount of which are at
Predixs discretion. Pursuant to the agreement, Predix
granted Mr. Schor an option to
purchase 19,444 shares of Predix common stock at an
exercise price of $1.80 per share, which vests as to 25% of
the shares on each of January 16, 2004, January 16,
2005, January 16, 2006 and January 16, 2007. In the
event Predix terminates Mr. Schors employment without
cause, as defined in the agreement, Mr. Schor is entitled
to receive his then-current base salary for a period of six
months. Under the agreement, Mr. Schor has agreed not to
compete with Predix for a period of six months after the
termination of his employment and not to solicit Predixs
customers or employees or interfere with any of Predixs
business relationships for a period of 12 months after the
termination of his employment. The agreement also contains
provisions relating to the protection of Predixs
confidential information and the assignment of inventions.
Pursuant to an employment agreement dated as of October 31,
2000, as amended on April 3, 2001, August 29, 2001,
May 12, 2003, August 8, 2003, June 18, 2004 and
June 9, 2005, between Predix Pharmaceuticals Ltd., a
wholly-owned subsidiary of Predix, and Silvia
Noiman, Ph.D., Predix employs Dr. Noiman as its Senior
Vice President of Pipeline Management and General Manager,
Israel. Under this agreement, Dr. Noimans base salary
is subject to Predixs review and adjustment annually.
Dr. Noiman is also eligible to receive bonuses, the timing,
type and amount of which are at Predixs discretion. Under
the agreement, Predix must provide Dr. Noiman managers
insurance, disability insurance, a Keren Hishtalmut
fund and any severance to which she may be entitled under
Israeli law. Pursuant to the agreement, Predix granted
Dr. Noiman 3,641 shares of Predix common stock, with a
fair market value of $1.80 per share, at no cost to
Dr. Noiman, a fully vested option to
purchase 6,104 shares of Predix common stock at an
exercise price of $1.80 per share and an option to
purchase 12,735 shares of Predix common stock at an
exercise price of $1.80 per share, which vests as to
3,183 shares on each of July 31, 2004, July 31,
2005, July 31, 2006 and July 31, 2007. Under the
agreement, Dr. Noiman has agreed not to compete with Predix
and not to solicit Predixs employees or consultants for a
period of 18 months after the termination of her
employment. The agreement also contains provisions relating to
the protection of
115
Predixs confidential information and the assignment of
inventions. The agreement continues until December 31, 2005
and automatically renews for additional one-year terms, unless
earlier terminated. Predix may terminate the agreement for
cause, as defined in the agreement, or without cause upon three
months notice. Dr. Noiman may terminate the agreement upon
three months notice. In addition, upon a merger, consolidation
or acquisition of Predix Pharmaceuticals Ltd. or if Predix
sells, leases or otherwise disposes of all or substantially all
of the assets of Predix Pharmaceuticals Ltd., Predix must extend
Dr. Noimans employment with Predix for a period of
six months or provide her six months compensation.
Pursuant to an employment agreement dated as of October 31,
2000, as amended on April 3, 2001, August 29, 2001,
May 12, 2003, August 8, 2003, and June 9, 2005,
between Predix Pharmaceuticals Ltd., a wholly-owned subsidiary
of Predix, and Oren Becker, Ph.D., Predix employs
Dr. Becker as its Chief Scientific Officer. Under this
agreement, Dr. Beckers base salary is subject to
Predixs review and adjustment annually. Dr. Becker is
also eligible to receive bonuses, the timing, type and amount of
which are at Predixs discretion. Under the agreement,
Predix must provide Dr. Becker managers insurance,
disability insurance, a Keren Hishtalmut fund and
any severance to which he may be entitled under Israeli law.
Pursuant to the agreement, Predix granted Dr. Becker 3,641
shares of Predix common stock, with a fair market value of $1.80
per share, at no cost to Dr. Becker, a fully vested option
to purchase 6,104 shares of Predix common stock at an exercise
price of $1.80 per share and an option to purchase 12,735 shares
of Predix common stock at an exercise price of $1.80 per share,
which vests as to 3,183 shares on each of July 31, 2004,
July 31, 2005, July 31, 2006 and July 31, 2007.
Under the agreement, Dr. Becker has agreed not to compete
with Predix and not to solicit Predixs employees or
consultants for a period of 18 months after the termination
of his employment. The agreement also contains provisions
relating to the protection of Predixs confidential
information and the assignment of inventions. The agreement
continues until December 31, 2006 and automatically renews
for additional one-year terms, unless earlier terminated. Predix
may terminate the agreement for cause, as defined in the
agreement, or without cause upon three months notice.
Dr. Becker may terminate the agreement upon three months
notice. In addition, upon a merger, consolidation or acquisition
of Predix Pharmaceuticals Ltd. or if Predix sells, leases or
otherwise disposes of all or substantially all of the assets of
Predix Pharmaceuticals Ltd., Predix must extend
Dr. Beckers employment with Predix for a period of
six months or provide him six months compensation.
Pursuant to an employment agreement dated as of February 8,
2005, as amended on June 1, 2005 between Predix and
Kimberlee C. Drapkin, CPA, Predix employs Ms. Drapkin as
its Chief Financial Officer on an at-will basis. Under this
agreement, Ms. Drapkins base salary is subject to
review and adjustment annually or at such other times as Predix
determines. However, Predix cannot decrease
Ms. Drapkins base salary unless the base salary of
all of Predixs similarly situated executives is decreased.
Under the agreement, Predix paid Ms. Drapkin a signing
bonus of $35,000 and she is also eligible to receive
performance-based bonuses, the timing and amount of which are at
Predixs discretion. Pursuant to the agreement, Predix
granted Ms. Drapkin an option to purchase 98,445 shares of
Predix common stock at an exercise price of $0.81 per share,
which vests over a four-year period with 25% of the shares
vesting on February 22, 2006, and the remainder in equal
monthly installments thereafter. In the event Predix terminates
Ms. Drapkins employment without cause, as defined in
the agreement, Ms. Drapkin is entitled to receive her
then-current base salary for a period of six months. Under the
agreement, Ms. Drapkin has agreed not to compete with
Predix for a period of two years after the termination of her
employment and not to solicit Predixs customers or
employees or interfere with any of Predixs business
relationships for a period of two years after the termination of
her employment. The agreement also contains provisions relating
to the protection of Predixs confidential information and
the assignment of inventions.
Pursuant to an employment agreement dated as of
September 27, 2004 between Predix and Stephen R. Donahue,
M.D., Predix employs Dr. Donahue as its Vice President of
clinical and regulatory affairs on an at-will basis. Under this
agreement, Dr. Donahues base salary is subject to
review and adjustment annually or at such other times as Predix
determines. However, Predix cannot decrease
Dr. Donahues base salary unless the base salary of
all of Predixs similarly situated executives is decreased.
Under the agreement, Predix paid Dr. Donahue a signing
bonus of $25,000 and he is also eligible to receive
116
performance-based bonuses, the timing and amount of which are at
Predixs discretion. Pursuant to the agreement, Predix
granted Dr. Donahue an option to purchase 60,607 shares of
Predix common stock at an exercise price of $0.81 per share,
which vests as to 6.25% of the shares every three months
beginning three months from September 24, 2004. In the
event Predix terminates Dr. Donahues employment
without cause, as defined in the agreement, Dr. Donahue is
entitled to receive his then-current base salary for a period of
six months. Under the agreement, Dr. Donahue has agreed not
to compete with Predix for a period of one year after the
termination of his employment and not to solicit Predixs
customers or employees or interfere with any of Predixs
business relationships for a period of one year after the
termination of his employment. The agreement also contains
provisions relating to the protection of Predixs
confidential information and the assignment of inventions.
Each option agreement between Predix and Drs. Kauffman, Becker,
Noiman and Donahue, Mr. Schor and Ms. Drapkin provides
that their options shall become immediately exercisable in full
if, after a reorganization event, as defined in Predixs
2003 Stock Incentive Plan, the acquiring or succeeding entity
assumes the option or substitute equivalent securities for the
option, and (a) the employee is terminated by the acquiring
or succeeding entity without cause, as defined in each option
agreement, within 12 months of the consummation of such
reorganization event or (b) the employee terminates his or
her employment with the acquiring or succeeding entity within
12 months of the consummation of such reorganization event
due to a material adverse change in the employees duties,
authority or responsibilities which causes the employees
position with the acquiring or succeeding entity to become of
less responsibility or authority.
Stock Plans
|
|
|
Amended and Restated 2003 Stock Incentive Plan |
Predixs 2003 Stock Incentive Plan was adopted by the
Predix board of directors in August 2003, and approved by
Predixs stockholders in August 2003. In August 2004 and
April 2005, the Predix board of directors and Predixs
stockholders approved amendments to Predixs 2003 Stock
Incentive Plan and in September 2005, this plan was amended and
restated by the Predix board of directors and Predixs
stockholders. Under this plan, Predix may grant incentive stock
options, nonqualified stock options and restricted stock and
other stock based awards. Pursuant to this plan, Predix has
created an Israeli sub-plan to grant options to those persons
who are residents of the State of Israel and who are deemed to
be residents of the State of Israel for tax purposes. A maximum
of 4,071,443 shares of Predix common stock are authorized
for issuance under this plan.
In accordance with the terms of this plan, the Predix board of
directors has authorized Predixs compensation committee to
administer the plan. In accordance with the provisions of this
plan, the Predix board of directors or compensation committee
will determine the terms of options and other awards, including:
|
|
|
|
|
the determination of which employees, directors, consultants and
other advisors will be granted options and other awards; |
|
|
|
the number of shares subject to options and other awards; |
|
|
|
the exercise price of each option which may not be less than
fair market value on the date of grant; |
|
|
|
the schedule upon which options become exercisable; |
|
|
|
the termination or cancellation provisions applicable to
options; the terms and conditions of other awards, including
conditions for repurchase, termination or cancellation, issue
price and repurchase price; and |
|
|
|
all other terms and conditions upon which each award may be
granted in accordance with this plan. |
No participant may receive awards for over 203,794 shares
of Predix common stock in any fiscal year. The Predix board of
directors or any committee to which the Predix board of
directors delegates authority may, with the consent of the
affected plan participants, amend outstanding awards consistent
with the
117
terms of this plan. Upon a merger or other reorganization event,
the Predix board of directors shall provide that all outstanding
options shall be assumed or substituted by the successor
corporation. If the successor corporation does not agree to
assume or substitute the options, then the Predix board of
directors shall provide that all outstanding options will become
exercisable in full as of a specified time prior to the
reorganization event and unexercised options shall terminate
immediately prior to the reorganization event. Notwithstanding
the foregoing, in the event of a reorganization event in which
the successor corporation does not agree to assume or substitute
the options and pursuant to which holders of Predix common stock
will receive a cash payment for each share surrendered then the
Predix board of directors may instead provide that all
outstanding options terminate upon consummation of the
reorganization event and each participant shall receive, in
exchange therefore, a cash payment equal to the difference, if
any, between the merger price times the number of shares of
Predix common stock subject to such outstanding options and the
aggregate exercise price of all such outstanding options.
Upon a merger or other reorganization event, any securities,
cash or other property received in exchange for shares of
restricted stock shall continue to be governed by the provisions
of any restricted stock agreement pursuant to which such
restricted stock was issued. As of September 23, 2005,
421,326 shares of Predix common stock have been issued
pursuant to options and stock awards granted under this plan,
2,214,642 shares of Predix common stock are subject to
outstanding options and 1,435,475 shares of Predix common
stock are available for future grant.
|
|
|
Physiome Sciences, Inc. 1997 Stock Option Plan |
Predix has terminated its 1997 Stock Option Plan under which
options to purchase 4,482 shares of Predix common
stock are currently outstanding. Although no more options may be
granted under this terminated plan, the terms of this plan
continue to apply to all such outstanding options. The Predix
board of directors or any committee to which the Predix board of
directors delegates authority may, with the consent of the
affected plan participants, amend outstanding awards consistent
with the terms of the 1997 Stock Option Plan.
401(k) Plan
In 2003, Predix adopted a 401(k) Plan covering all qualified
U.S. employees of Predix. Participants may contribute up to
25% of their annual compensation, subject to statutory
limitations, and Predix may declare discretionary matching
contributions to this 401(k) Plan. Predixs matching
contribution for the year ended December 31, 2003 totaled
$2,000 and is fully vested. Predix did not match any
contributions for the years ended December 31, 2004 or
December 31, 2005.
Certain Transactions With Management and Affiliates
The following is a description of the transactions Predix has
engaged in since January 1, 2003 with its directors,
officers and beneficial owners of more than five percent of its
voting securities and their affiliates.
|
|
|
Recapitalization and Acquisition of Predix Pharmaceuticals
Ltd. |
In August 2003, Predix effected a recapitalization of its
capital stock and acquired Predix Pharmaceuticals Ltd., an
Israeli corporation. In connection with the recapitalization
Predix:
|
|
|
|
|
created a new class of Class A common stock, or the
Class A common stock; |
|
|
|
reclassified all outstanding shares of its then existing
Series A convertible preferred stock into a newly created
Series A convertible preferred stock, or the New
Series A stock , on a 1-for-0.022104 basis; |
|
|
|
reclassified all outstanding shares of its then existing
Series B convertible preferred stock into New Series A
stock on a 1-for-0.035661 basis; |
118
|
|
|
|
|
reclassified all outstanding shares of its then existing
Series C convertible preferred stock into New Series A
stock on a 1-for-0.084149 basis; and |
|
|
|
reclassified all outstanding shares of its then existing
Series D convertible preferred stock into a newly created
Series B convertible preferred stock, or the New
Series B stock, on a 1-for-0.123774 basis. |
In connection with this recapitalization, the following
directors, officers, beneficial owners of more than five percent
of Predix voting securities and their affiliates received the
following shares of capital stock:
|
|
|
|
|
Eaton Vance Worldwide Health Sciences Portfolio and Finsbury
Worldwide Pharma, each an affiliate of OrbiMed Advisors LLC, a
beneficial owner of more than five percent of Predixs
common stock, received an aggregate of 103,360 shares of
New Series B stock in exchange for an aggregate of
835,072 shares of Predixs then existing Series D
convertible preferred stock. Jonathan Silverstein, a member of
the Predix board of directors, is a general partner at OrbiMed
Advisors LLC. |
|
|
|
PA International Limited, a beneficial owner of more than five
percent of Predixs common stock, received
216,125 shares of New Series A stock in exchange for
2,568,371 shares of Predixs then existing
Series C convertible preferred stock. |
|
|
|
SR One Limited, a beneficial owner of more than five percent of
Predixs common stock, received 43,225 shares of New
Series A stock in exchange for 1,212,122 shares of
Predixs then existing Series B convertible preferred
stock and 28,657 shares of Series B Stock in exchange
for 231,528 shares of Predixs then existing
Series D convertible preferred stock. |
Predix acquired Predix Pharmaceuticals Ltd. through a share
exchange in which Predix purchased all of the outstanding
capital stock of Predix Pharmaceuticals Ltd. and immediately
thereafter, the former stockholders of Predix Pharmaceuticals
Ltd. used the proceeds from this stock purchase to purchase
shares of Predix capital stock. In connection with this share
exchange, Predix purchased an aggregate of
15,842,274 preferred shares and 100,000 ordinary shares of
Predix Pharmaceuticals Ltd. for an aggregate cash equivalent
purchase price of approximately $7.7 million, including the
following from directors, officers, beneficial owners of more
than five percent of Predixs voting securities and their
affiliates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
Number of | |
|
|
|
|
Preferred Shares | |
|
Ordinary Shares | |
|
Equivalent Cash | |
Name |
|
Purchased | |
|
Purchased | |
|
Purchase Price | |
|
|
| |
|
| |
|
| |
Silvia Noiman, Ph.D.(1)
|
|
|
|
|
|
|
24,000 |
|
|
$ |
14,692 |
|
Oren Becker, Ph.D.(2)
|
|
|
|
|
|
|
24,000 |
|
|
|
14,692 |
|
Frederick Frank(3)
|
|
|
121,556 |
|
|
|
|
|
|
|
58,280 |
|
Yozma II (Israel) L.P.(4)
|
|
|
1,610,158 |
|
|
|
|
|
|
|
772,110 |
|
YVC-Yozma Management & Investments Ltd, as trustees for
Yozma II (BVI) L.P.(4)
|
|
|
2,744,594 |
|
|
|
|
|
|
|
1,316,110 |
|
PCM Venture Capital L.P.(4)
|
|
|
1,463,786 |
|
|
|
|
|
|
|
701,930 |
|
OrbiMed Associates LLC(5)
|
|
|
176,636 |
|
|
|
|
|
|
|
84,690 |
|
UBS PW Juniper Crossover Fund LLC(5)
|
|
|
2,471,433 |
|
|
|
|
|
|
|
1,185,130 |
|
Caduceus Private Investments, L.P.(5)
|
|
|
7,254,111 |
|
|
|
|
|
|
|
3,478,570 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
15,842,274 |
|
|
|
48,000 |
|
|
$ |
7,262,204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Dr. Noiman is Predixs Senior Vice President of
Pipeline Management and General Manager of Israel operations. |
|
(2) |
Dr. Becker is Predixs Chief Scientific Officer. |
|
(3) |
Mr. Frank is chairman of the Predix board of directors. |
119
|
|
(4) |
Yozma II (Israel) L.P., YVC-Yozma Management &
Investment Ltd, as trustees for Yozma II (BVI) L.P.
and PCM Venture Capital L.P. are affiliates of the Yozma Group,
a beneficial owner of more than five percent of Predixs
voting securities. Yigal Erlich, a member of the Predix board of
directors, is the founder and managing partner of the Yozma
Group. |
|
(5) |
OrbiMed Associates LLC, UBS PW Juniper Crossover Fund LLC
and Caduceus Private Investments, L.P. are affiliates of OrbiMed
Advisors LLC. In connection with Predixs acquisition of
Predix Pharmaceuticals Ltd., Predix entered into an agreement
with OrbiMed Associates LLC, UBS PW Juniper Crossover
Fund LLC and Caduceus Private Investments, L.P., or
collectively, the OrbiMed Entities, pursuant to which the
OrbiMed Entities agreed to indemnify Predix against any and all
Israeli capital gains taxes which Predix may be required to pay
in connection with Israeli withholding tax obligations in
connection with Predixs purchase of the shares of Predix
Pharmaceuticals Ltd. owned by the OrbiMed Entities. This
agreement has a term of six years. |
In connection with this share exchange, Predix sold an aggregate
of 3,400 shares of Predix common stock, 587,418 shares
of New Series A stock and 172,264 shares of New
Series B stock for an aggregate cash equivalent sale price
of approximately $7.7 million, including the following to
directors, officers, beneficial owners of more than five percent
of Predixs voting securities and their affiliates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
Number of | |
|
Number of | |
|
|
|
|
Shares of Predix | |
|
Shares of | |
|
Shares of | |
|
|
|
|
Common Stock | |
|
New Series A | |
|
New Series B | |
|
Equivalent Cash | |
Name |
|
Sold(1) | |
|
Stock Sold(1) | |
|
Stock Sold(1) | |
|
Purchase Price | |
|
|
| |
|
| |
|
| |
|
| |
Silvia Noiman, Ph.D.
|
|
|
816 |
|
|
|
|
|
|
|
|
|
|
$ |
14,692 |
|
Oren Becker, Ph.D.
|
|
|
816 |
|
|
|
|
|
|
|
|
|
|
|
14,692 |
|
Frederick Frank
|
|
|
|
|
|
|
4,507 |
|
|
|
1,321 |
|
|
|
58,280 |
|
Yozma II (Israel) L.P.
|
|
|
|
|
|
|
59,703 |
|
|
|
17,508 |
|
|
|
772,110 |
|
YVC-Yozma Management & Investments Ltd, as trustees for
Yozma II (BVI) L.P.
|
|
|
|
|
|
|
101,767 |
|
|
|
29,844 |
|
|
|
1,316,110 |
|
PCM Venture Capital L.P.
|
|
|
|
|
|
|
54,276 |
|
|
|
15,917 |
|
|
|
701,930 |
|
OrbiMed Associates LLC
|
|
|
|
|
|
|
6,549 |
|
|
|
1,920 |
|
|
|
84,690 |
|
UBS PW Juniper Crossover Fund LLC
|
|
|
|
|
|
|
91,639 |
|
|
|
26,874 |
|
|
|
1,185,130 |
|
Caduceus Private Investments, L.P.
|
|
|
|
|
|
|
268,977 |
|
|
|
78,880 |
|
|
|
3,478,570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
1,632 |
|
|
|
587,418 |
|
|
|
172,264 |
|
|
$ |
7,626,204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Each share of New Series A stock and New Series B
stock was convertible into ten shares of Predix common stock. In
August 2004, the New Series A stock and New Series B
stock were converted into shares of Predix common stock or
Series AB preferred stock in connection with the initial
issuance of Predixs Series C preferred stock and the
recapitalization as described in further detail below. |
In connection with the recapitalization and the acquisition of
Predix Pharmaceuticals Ltd., each holder of Predix preferred
stock and each holder of preferred stock of Predix
Pharmaceuticals Ltd. received a transaction warrant and a
funding warrant. Each transaction warrant entitled the holder to
purchase its pro rata share of up to 1,000,000 shares of
New Series B stock prior to August 8, 2004 at an
amended exercise price of $5.00 per share. Each funding
warrant entitled the holder to purchase its pro rata share of
shares of Predix capital stock issued in a third party
financing. The funding warrants were exercisable for a period of
five years; provided, however, that at any time a funding
warrant was entitled to be exercised, but was not exercised, it
terminated. All of these transaction warrants and funding
warrants have been terminated, exercised or expired without
exercise. Predix issued transaction warrants and
120
funding warrants to the following directors, officers,
beneficial owners of more than five percent of its voting
securities and their affiliates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Rata Portion | |
|
|
Maximum Shares of | |
|
of Subsequent | |
|
|
New Series B Stock | |
|
Financings | |
|
|
Purchasable with | |
|
Under Funding | |
Name |
|
Transaction Warrant | |
|
Warrant | |
|
|
| |
|
| |
Stockholders of Predix Pharmaceuticals Ltd.
|
|
|
|
|
|
|
|
|
Frederick Frank
|
|
|
2,301 |
|
|
|
0.23 |
% |
Yozma II (Israel) L.P.
|
|
|
30,491 |
|
|
|
3.05 |
|
YVC-Yozma Management & Investments Ltd, as trustees for
Yozma II (BVI) L.P.
|
|
|
51,974 |
|
|
|
5.20 |
|
PCM Venture Capital L.P.
|
|
|
27,719 |
|
|
|
2.77 |
|
OrbiMed Associates LLC
|
|
|
3,344 |
|
|
|
0.33 |
|
UBS PW Juniper Crossover Fund LLC
|
|
|
46,801 |
|
|
|
4.68 |
|
Caduceus Private Investments, L.P.
|
|
|
137,372 |
|
|
|
13.74 |
|
Stockholders of Predix
|
|
|
|
|
|
|
|
|
Eaton Vance Worldwide Health Sciences Portfolio
|
|
|
25,511 |
|
|
|
2.55 |
|
Finsbury Worldwide Pharma
|
|
|
15,306 |
|
|
|
1.53 |
|
PA International Limited
|
|
|
85,349 |
|
|
|
8.53 |
|
SR One Limited
|
|
|
28,386 |
|
|
|
2.84 |
|
|
|
|
|
|
|
|
|
Total
|
|
|
454,554 |
|
|
|
45.50 |
% |
|
|
|
|
|
|
|
Upon consummation of the acquisition of Predix Pharmaceuticals
Ltd., Predix granted options to purchase an aggregate of
144,256 shares of Class A common stock at an exercise
price of $1.80 per share and an aggregate of
7,341 shares of Class A common stock having a fair
market value of $1.80 per share, at no cost, to certain
directors, officers and employees of the combined company,
including the following directors, officers, beneficial owners
of more than five percent of Predixs voting securities and
their affiliates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to | |
|
|
Shares of Class A | |
|
Purchase Class A | |
Name |
|
Common Stock(1) | |
|
Common Stock(1) | |
|
|
| |
|
| |
Michael G. Kauffman, M.D., Ph.D.(2)
|
|
|
59 |
|
|
|
42,056 |
|
Silvia Noiman, Ph.D.
|
|
|
3,641 |
|
|
|
18,839 |
|
Oren Becker, Ph.D.
|
|
|
3,641 |
|
|
|
|
|
Frederick Frank
|
|
|
|
|
|
|
397 |
|
|
|
|
|
|
|
|
|
Total
|
|
|
7,341 |
|
|
|
90,812 |
|
|
|
|
|
|
|
|
|
|
(1) |
In August 2004, the Class A common stock was converted into
shares of Predix common stock in connection with the initial
issuance of the Series C preferred stock and the
recapitalization as described in further detail below. |
|
(2) |
Dr. Kauffman is Predixs President and Chief Executive
Officer and a member of the Predix board of directors. |
|
|
|
Issuances of Series C Preferred Stock and
Recapitalization |
On August 9, 2004, Predix effected a recapitalization of
its capital stock and raised an aggregate of $14,710,540 through
the sale and issuance of shares of its Series C preferred
stock in a private financing. In connection with this financing,
Predix issued an aggregate of 66,753,820 shares of
Series C preferred stock to 42 of Predixs then
existing stockholders and their affiliates at a purchase price
of $0.22037 per
121
share, including the following to directors, officers,
beneficial owners of more than five percent of Predixs
voting securities and their affiliates:
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Series C | |
|
Aggregate | |
Name |
|
Preferred Stock | |
|
Purchase Price | |
|
|
| |
|
| |
SR One Limited
|
|
|
22,689,112 |
|
|
$ |
5,000,000 |
|
Michael G. Kauffman, M.D., Ph.D.
|
|
|
4,538 |
|
|
|
1,000 |
|
Frederick Frank
|
|
|
226,891 |
|
|
|
50,000 |
|
OrbiMed Associates LLC
|
|
|
337,970 |
|
|
|
74,478 |
|
UBS PW Juniper Crossover Fund LLC
|
|
|
4,729,409 |
|
|
|
1,042,220 |
|
Caduceus Private Investments, L.P.
|
|
|
13,881,629 |
|
|
|
3,059,095 |
|
Eaton Vance Worldwide Health Sciences Portfolio
|
|
|
2,337,565 |
|
|
|
515,129 |
|
Hare and Co. FAO: Finsbury Worldwide Pharmaceutical Trust
|
|
|
1,402,539 |
|
|
|
309,078 |
|
Yozma II (Israel) L.P.
|
|
|
2,692,671 |
|
|
|
593,384 |
|
Yozma Venture Capital Ltd.(1)
|
|
|
1,000,613 |
|
|
|
220,505 |
|
YVC-Yozma Management & Investments Ltd, as trustees for
Yozma II (BVI) L.P.
|
|
|
4,589,826 |
|
|
|
1,011,460 |
|
PCM Venture Capital L.P.
|
|
|
2,447,924 |
|
|
|
539,449 |
|
|
|
|
|
|
|
|
|
Total
|
|
|
56,340,687 |
|
|
$ |
12,415,798 |
|
|
|
|
|
|
|
|
|
|
(1) |
Yozma Venture Capital Ltd. is an affiliate of the Yozma Group. |
The Series C preferred stock is convertible into shares of
Predix common stock on a
1-for-18 basis. The
purchase price per share of Series C preferred stock was
the fair market value as determined by arms-length negotiations
between sophisticated investors and Predixs management and
the Predix board of directors.
In connection with the sale and issuance of the Series C
preferred stock, Predix effected a recapitalization of its
capital stock through the exchange of each share of New
Series A stock and New Series B stock into shares of
newly created Series AB preferred stock or Predix common
stock and the reclassification of each share of Class A
common stock into one share of Predix common stock. In
connection with the recapitalization, Predix exchanged:
|
|
|
|
|
each share of New Series A stock and New Series B
stock held by a stockholder that purchased at least
51 percent of its pro rata portion of Series C
preferred stock sold in the financing into ten shares of newly
created Series AB preferred stock (convertible on a
1-for-18 basis into
shares of Predix common stock) and granted each such stockholder
a warrant to purchase shares of newly created Series AB
preferred stock at an exercise price of $0.01 per share
prior to August 9, 2009; and |
|
|
|
each share of New Series A stock and New Series B
stock held by a stockholder that did not purchase at least
51 percent of its pro rata portion of Series C
preferred stock sold in the financing into 0.5556 shares of
Predix common stock. |
As part of this transaction, Predix exchanged:
|
|
|
|
|
an aggregate of 732,347 shares of New Series A stock
and an aggregate of 720,799 shares of New Series B
stock for an aggregate of 14,531,460 shares of
Series AB preferred stock and granted warrants to purchase
an aggregate of 62,240,212 shares of Series AB
preferred stock; and |
|
|
|
an aggregate of 335,623 shares of New Series A stock
and an aggregate of 743,456 shares of New Series B
stock for an aggregate of 599,488 shares of Predix common
stock. |
122
Predix directors, officers, beneficial owners of more than five
percent of Predixs voting securities and their affiliates
participated in this exchange as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
|
Number of | |
|
Number of | |
|
Number of | |
|
Number of | |
|
Warrants to | |
|
|
Shares of | |
|
Shares of | |
|
Shares of | |
|
Shares of | |
|
Purchase | |
|
|
New Series A | |
|
New Series B | |
|
Predix | |
|
Series AB | |
|
Series AB | |
|
|
Stock | |
|
Stock | |
|
Common Stock | |
|
Preferred Stock | |
|
Preferred Stock | |
Name |
|
Exchanged | |
|
Exchanged | |
|
Issued | |
|
Issued | |
|
Issued | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
SR One Limited
|
|
|
43,225 |
|
|
|
28,657 |
|
|
|
|
|
|
|
718,820 |
|
|
|
3,619,477 |
|
Frederick Frank
|
|
|
4,507 |
|
|
|
1,321 |
|
|
|
|
|
|
|
58,280 |
|
|
|
293,458 |
|
OrbiMed Associates LLC
|
|
|
6,549 |
|
|
|
2,791 |
|
|
|
|
|
|
|
93,400 |
|
|
|
470,297 |
|
UBS PW Juniper Crossover Fund LLC
|
|
|
91,639 |
|
|
|
39,061 |
|
|
|
|
|
|
|
1,307,000 |
|
|
|
6,581,142 |
|
Caduceus Private Investments, L.P.
|
|
|
268,977 |
|
|
|
114,650 |
|
|
|
|
|
|
|
3,836,270 |
|
|
|
19,316,785 |
|
Eaton Vance Worldwide Health Sciences Portfolio
|
|
|
|
|
|
|
64,600 |
|
|
|
|
|
|
|
646,000 |
|
|
|
3,252,806 |
|
Hare and Co. FAO: Finsbury Worldwide Pharmaceutical Trust
|
|
|
|
|
|
|
38,760 |
|
|
|
|
|
|
|
387,600 |
|
|
|
1,951,684 |
|
Yozma II (Israel) L.P.
|
|
|
59,703 |
|
|
|
17,508 |
|
|
|
|
|
|
|
772,110 |
|
|
|
3,887,808 |
|
Yozma Venture Capital Ltd.
|
|
|
|
|
|
|
28,692 |
|
|
|
|
|
|
|
286,920 |
|
|
|
1,444,729 |
|
YVC-Yozma Management & Investments Ltd, as trustees for
Yozma II (BVI) L.P.
|
|
|
101,767 |
|
|
|
29,844 |
|
|
|
|
|
|
|
1,316,110 |
|
|
|
6,627,011 |
|
PCM Venture Capital L.P.
|
|
|
54,726 |
|
|
|
15,917 |
|
|
|
|
|
|
|
701,930 |
|
|
|
3,534,430 |
|
PA International Limited
|
|
|
216,125 |
|
|
|
|
|
|
|
120,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
847,218 |
|
|
|
381,801 |
|
|
|
120,069 |
|
|
|
10,124,440 |
|
|
|
50,979,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As a result of this recapitalization, each option and warrant to
purchase shares of Class A common stock became exercisable
for the same number of shares of Predix common stock, at the
same exercise price per share, for which such options and
warrants were originally exercisable and each warrant
exercisable for New Series A stock became exercisable for
shares of Predix common stock on a 1-for-0.5556 basis.
123
During the period from September 9, 2004 to
January 21, 2005, Predix raised an aggregate of $25,505,742
through the sale and issuance of an aggregate of 115,740,536
additional shares of Series C preferred stock to 16
investors at a purchase price of $0.22037 per share,
including the following to directors, officers, beneficial
owners of more than five percent of Predixs voting
securities and their affiliates:
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
|
|
|
Shares of | |
|
|
|
|
Series C | |
|
Aggregate | |
Name |
|
Preferred Stock | |
|
Purchase Price | |
|
|
| |
|
| |
Astellas Venture Capital LLC(1)
|
|
|
15,882,380 |
|
|
$ |
3,500,000 |
|
Boston Millennia Partners II Limited Partnership(2)
|
|
|
18,843,979 |
|
|
|
4,152,648 |
|
Boston Millennia Partners GmbH & Co. KG(2)
|
|
|
2,683,400 |
|
|
|
591,341 |
|
Boston Millennia Partners II-A Limited Partnership(2)
|
|
|
902,673 |
|
|
|
198,922 |
|
Strategic Advisors Fund Limited Partnership(2)
|
|
|
169,438 |
|
|
|
37,339 |
|
Boston Millennia Associates II Partnership(2)
|
|
|
89,622 |
|
|
|
19,750 |
|
Forward Ventures V, L.P.(3)
|
|
|
24,958,025 |
|
|
|
5,500,000 |
|
CMEA Ventures Life Sciences 2000, L.P.(4)
|
|
|
6,765,046 |
|
|
|
1,490,813 |
|
CMEA Ventures Life Sciences 2000, Civil Law Partnership(4)
|
|
|
406,787 |
|
|
|
89,644 |
|
CMEA Ventures VI, L.P.(4)
|
|
|
12,948,730 |
|
|
|
2,853,512 |
|
CMEA Ventures VI, GmbH & Co. K.G.(4)
|
|
|
299,639 |
|
|
|
66,031 |
|
PA International Limited
|
|
|
6,719,347 |
|
|
|
1,480,743 |
|
|
|
|
|
|
|
|
|
Total
|
|
|
90,669,066 |
|
|
$ |
19,980,743 |
|
|
|
|
|
|
|
|
|
|
(1) |
Formerly known as Yamanouchi Venture Capital, LLC. Astellas
Venture Capital LLC is a beneficial owner of more than five
percent of Predixs voting securities. |
|
(2) |
Boston Millennia Partners GmbH & Co. KG, Boston
Millennia Partners II-A Limited Partnership, Strategic Advisors
Fund Limited Partnership and Boston Millennia
Associates II Partnership are affiliates of Boston
Millennia Partners II Limited Partnership, a beneficial
owner of more than five percent of Predixs voting
securities. Patrick J. Fortune, Ph.D., a member of the
Predix board of directors, is a partner at Boston Millennia
Partners. |
|
(3) |
Forward Ventures V, L.P. is a beneficial owner of more than
five percent of Predixs voting securities. Joel
Martin, Ph.D., a member of the Predix board of directors,
is a partner at Forward Ventures. |
|
(4) |
CMEA Ventures Life Sciences 2000, L.P., CMEA Ventures Life
Sciences 2000, Civil Law Partnership and CMEA Ventures VI,
GmbH & Co. K.G. are affiliates of CMEA Ventures VI,
L.P., a beneficial owner of more than five percent of
Predixs voting securities. David Collier, M.D., a
member of the Predix board of directors, is a General Partner of
CMEA Ventures. |
|
|
|
Issuance of Notes and Warrants |
In March 2006, Predix closed a financing of convertible
promissory notes and warrants in the aggregate amount of
$9,500,000. The convertible promissory notes bear interest at
10% per annum and mature on March 31, 2007, provided,
that if the merger is consummated prior to August 1, 2006,
all principal and accrued interest due under the convertible
promissory notes must be repaid in full within one month of the
closing. If the merger is not consummated prior to
August 1, 2006, the interest rate will increase from
10% per annum to 15% per annum, retroactive to the
date of the issuance of the convertible promissory notes, and
under certain circumstances the convertible promissory notes
will convert into shares of a new series of Predix preferred
stock. In connection with the purchase of the convertible
promissory notes, Predix also issued warrants to purchase an
aggregate of 200,239 shares of Predix common stock at
$0.01 per share. These warrants terminate upon the
consummation of the merger, provided that immediately prior to
the effective time the warrants will be deemed exercised in the
aggregate amount of 200,239 shares of Predix common stock.
124
The following Predix directors, officers, beneficial owners of
more than five percent of Predixs voting securities and
their affiliates participated in this financing as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Number of Warrant | |
|
|
|
|
Shares Exercisable | |
|
|
|
|
for Predix | |
|
Principal Amount | |
Name |
|
Common Stock | |
|
of Notes | |
|
|
| |
|
| |
Caduceus Private Investments, LP
|
|
|
71,746 |
|
|
$ |
3,403,888.56 |
|
OrbiMed Associates LLC
|
|
|
1,747 |
|
|
|
82,873.00 |
|
UBS Juniper Crossover Fund, L.L.C
|
|
|
24,444 |
|
|
|
1,159,689.58 |
|
Finsury Worldwide Pharmaceutical Trust
|
|
|
2,742 |
|
|
|
130,113.29 |
|
S.R. One Limited
|
|
|
19,089 |
|
|
|
939,817.82 |
|
Boston Millennia Partners II Limited Partnership
|
|
|
28,208 |
|
|
|
1,338,274.19 |
|
Boston Millennia Partners II-A Limited Partnership
|
|
|
1,351 |
|
|
|
64,106.62 |
|
Boston Millennia Partners GmbH & Co. KG
|
|
|
4,017 |
|
|
|
190,571.49 |
|
Strategic Advisors Fund Limited Partnership
|
|
|
254 |
|
|
|
12,033.31 |
|
Boston Millennia Associates Partnership
|
|
|
134 |
|
|
|
6,364.83 |
|
CMEA Ventures Life Sciences 2000, L.P.
|
|
|
11,254 |
|
|
|
533,925.33 |
|
CMEA Ventures Life Sciences 2000, Civil Law Partnership
|
|
|
675 |
|
|
|
32,001.34 |
|
CMEA Ventures VI, L.P.
|
|
|
21,535 |
|
|
|
1,021,683.70 |
|
CMEA Ventures VI, GmbH & Co. K.G
|
|
|
500 |
|
|
|
23,740.07 |
|
PA International Limited
|
|
|
11,823 |
|
|
|
560,916.87 |
|
|
|
|
|
|
|
|
|
Total
|
|
|
200,239 |
|
|
$ |
9,500,000 |
|
|
|
|
|
|
|
|
Predix is currently a party to the Second Amended and Restated
Stockholders Agreement dated January 21, 2005 by and among
Predix and certain of its stockholders, as amended on
August 1, 2005 and March 31, 2006 that provides for
certain registration rights, voting rights, rights of first
refusal, transfer restrictions, preemptive rights and co-sale
rights. In connection with the merger, this agreement will be
terminated immediately prior to the consummation of the merger.
|
|
|
Agreements with Executive Officers and Directors |
Predix has employment agreements with Michael G.
Kauffman, M.D., Ph.D., Chen Schor, CPA, Silvia
Noiman, Ph.D., Oren Becker, Ph.D., Kimberlee C.
Drapkin, CPA, and Stephen Donahue, M.D., which provide for
certain salary and bonus compensation. For more information
regarding these agreements, see Current Management of
Predix and Related Information Employment
Agreements.
Each option agreement between Predix and Drs. Kauffman, Noiman,
Becker and Donahue and Mr. Schor and Ms. Drapkin
provides that their options shall become immediately exercisable
in full if, within one year after a change in control, the
employee is terminated without cause. For more information
regarding these agreements, see Current Management of
Predix and Related Information Change of Control
Arrangements.
For information regarding stock options and stock awards granted
to our named executive officers and directors, see Current
Management of Predix and Related Information Stock
Plans.
|
|
|
Engagement of Lehman Brothers Inc. |
Mr. Frank, the Chairman of the Predix board of directors,
is also the Vice Chairman and a director of Lehman
Brothers Inc., Predixs financial advisor in
connection with the merger. Under the terms of the engagement
with Lehman Brothers, Predix agreed to pay Lehman Brothers a fee
of $2.0 million upon consummation of the merger. In
addition, whether or not the merger is consummated, Predix has
also agreed to reimburse Lehman Brothers for its reasonable
out-of-pocket expenses
up to $50,000, and to indemnify it against certain liabilities
relating to or arising out of services performed by Lehman
Brothers.
125
EPIXS BUSINESS
Overview
EPIX discovers and develops innovative pharmaceuticals for
imaging that are designed to transform the diagnosis, treatment
and monitoring of disease. EPIX uses its proprietary Target
Visualization Technology to create imaging agents targeted at
the molecular level. These agents are designed to enable
physicians to use magnetic resonance imaging, or MRI, to obtain
detailed information about specific disease processes.
MRI has been established as the imaging technology of
choice for a broad range of applications, including the
identification and diagnosis of a variety of medical disorders.
MRI is safe, relatively cost-effective and provides
three-dimensional images that enable physicians to diagnose and
manage disease in a minimally invasive manner.
EPIX is currently developing two products for use in MRI to
improve the diagnosis of multiple diseases involving the
bodys arteries and veins, collectively known as the
vascular system: Vasovist, EPIXs novel blood-pool contrast
agent for use in magnetic resonance angiography, or MRA, which
was approved for marketing in all 25 member states of the
European Union, or E.U., in October 2005; and EP-2104R, for use
in detecting human thrombi, or blood clots, using MRI. EPIX has
entered into various partnership agreements with Schering AG
with respect to both Vasovist and EP-2104R. In addition, EPIX
has active research programs with respect to products for
diagnostic imaging and therapeutic uses.
Recent Events
In September 2005, EPIXs board of directors appointed
Michael J. Astrue as Interim Chief Executive Officer.
Mr. Astrue replaced Michael Webb, who resigned from EPIX
and its board of directors in September 2005. In addition,
EPIXs Chief Financial Officer resigned in July 2005. EPIX
currently has no Chief Financial Officer and its Executive
Director, Finance, is serving as its Principal Accounting
Officer.
|
|
|
Regulatory Update for Vasovist |
In December 2003, EPIX submitted a new drug application, or NDA,
for Vasovist to the U.S. Food and Drug Administration, or
FDA. In January 2005, EPIX received an approvable letter from
the FDA for Vasovist in which the FDA requested additional
clinical trials prior to approval. In May 2005, EPIX submitted a
response to the FDA approvable letter, which was accepted by the
FDA as a complete response in June 2005. In November 2005, the
FDA provided EPIX with a second approvable letter. The second
approvable letter indicated that at least one additional
clinical trial and a re-read of images obtained in certain
previously completed Phase III clinical trials would be
necessary before the FDA would consider approving Vasovist. EPIX
believes that these trials will require a substantial period of
time to complete. No safety or manufacturing issues were raised
in either approvable letter. EPIX is working with outside
regulatory and clinical consultants and the FDA to determine its
next steps with respect to Vasovist in the United States. EPIX
met with the FDA in January 2006 and April 2006 to discuss the
path forward for Vasovist and EPIX is currently considering all
of its options with respect to Vasovist, including formally
appealing the FDAs decision to require an additional
clinical trial and/or conducting one or more additional clinical
trials.
In October 2005, the European Medicines Agency, or EMEA, granted
marketing approval of Vasovist for all 25 member states of the
E.U. Schering AG, EPIXs partner for Vasovist, began
marketing Vasovist in the Netherlands in April 2006 and EPIX
expects that Schering AG will begin marketing Vasovist in
additional countries in Europe.
126
As a result of the FDAs second approvable letter regarding
Vasovist, EPIX eliminated approximately 50% of its workforce in
January 2006. The reductions affected both EPIXs research
and development and its general and administrative areas. Prior
to the initial announcement on November 23, 2005 of
EPIXs intention to reduce its workforce, EPIX had 93
employees. Following the completion of the reduction, EPIX has
approximately 44 employees.
The workforce reduction resulted in a one-time charge of
approximately $1.0 million, which was recognized in the
fourth quarter of 2005. Pending any increases in spending
associated with FDA-related activity with respect to Vasovist or
any changes in spending that result from a transformative
transaction, EPIX expects that the reductions in staff should
reduce its projected use of cash in 2006 by
approximately 30%, or $7 million, excluding
non-recurring cash payments associated with the reduction. In
2005, EPIX had a cash burn of approximately $25 million.
Several employees included in the reduction will terminate their
employment later in 2006 as they complete work on important
activities.
Under this reorganization, EPIX plans to focus its resources
primarily on the development of its lead product candidates,
Vasovist and EP-2104R. Accordingly, EPIX has decided to cease
work on the majority of its research projects related to
imaging. EPIX continues to allocate resources to one
high-priority research project.
EP-2104R entered Phase II clinical trials in April 2005. In
July 2005, EPIX announced that it would be amending its
Phase II
proof-of-concept
clinical trial protocols for EP-2104R to include additional
patient safety monitoring based on a review by the FDA of
observations from a
14-day, repeat dose
pre-clinical toxicology study. EPIX believes that these
observations, which were evident in both treated and untreated
test animals, are not related to EP-2104R. The additional
patient monitoring requested by the FDA in the Phase II
trials has extended the timeline and increased the cost for
EP-2104R development. Most recently, EPIX announced that it has
successfully accelerated the enrollment in the Phase II
trials and completed enrollment in the first quarter of 2006.
EPIX further indicated that its has seen encouraging images,
which may be indicative of EP-2104Rs potential utility for
identifying patients at risk of acute thrombotic events, such as
stroke.
|
|
|
Fibrin-Binding Therapeutic Program |
EPIX has completed
proof-of-concept
studies for its anticoagulant therapeutic program and intends to
pursue the licensing of this technology to a larger therapeutic
company for further development. For these tests, EPIX used a
proprietary molecule derived from its patented technology and
attached the molecule to the direct thrombin inhibitor
melagatran, the active form of Exanta. Results from animal
studies were mixed, with one model demonstrating positive
results and one model generating significantly less positive
data. EPIX believes that the combined information is
sufficiently encouraging that a larger pharmaceutical company
may be interested in evaluating the potential of this technology
in next-generation anticoagulant and antithrombotic drugs. The
fibrin-binding technology may allow for more specific targeting
of these drugs, which in turn, may result in a reduced risk of
the bleeding associated with anti-coagulation.
In October 2005, EPIX announced that an amendment to the
research collaboration agreement had been entered into with
Schering AG. This amendment narrows the definition of the field
of EPIXs collaboration with Schering AG. This research
collaboration expires in May 2006, and EPIX believes that it is
unlikely that the parties will extend the term of the
collaboration. EPIX expects to discuss the disposition of
current research programs with Schering AG prior to expiration
of the collaboration and to continue to advance at least some of
these programs either on its own or with another partner.
127
In June 2004, EPIX entered into a loan agreement with Schering
AG which entitled EPIX to borrow up to $15.0 million from
time to time. EPIX repaid the loan in full in October 2005, and
in January 2006, EPIX terminated the loan agreement with
Schering AG.
EPIX Technology
EPIXs product candidates are small molecule chelates,
which are soluble metal-organic complexes, containing a
magnetically active metal element, gadolinium, which elicits a
strong MRI signal. EPIX has designed its product candidate
molecules based on their chemical, pharmacological and
biophysical attributes and profile. EPIXs compounds must
be safe, easily eliminated from the body, and display a useful
distribution pattern in the body. At the same time, these agents
must elicit the strongest possible effect on the local magnetic
properties of tissue.
EPIX develops chelates where one portion is engineered to bind
to particular proteins in the body. This binding causes
increased concentration and retention of the contrast agent in
the specific tissues and fluids that contain the targeted
molecules. The chemical structure of Vasovist, for example, is
designed to bind selectively to albumin, the most common blood
protein, which keeps the agent localized within the bloodstream
for an extended period of imaging. In designing EP-2104R for use
in imaging blood clots, EPIX has used phage display to select a
family of highly specific peptides that bind to fibrin, the
dominant protein inside clots, without binding to circulating
plasma proteins, including fibrinogen, a similar but far less
clot-specific protein in blood.
The binding of a contrast agent to its receptor reduces the rate
at which the agent rotates in solution. This reduced rotation
rate leads to a complex magnetic effect whereby the agents
signal-enhancing characteristics are substantially increased,
resulting in a stronger signal during MRI scans. For Vasovist,
binding to albumin results in an up to 10-fold increase in
signal relative to non-specific gadolinium agents. EPIX also has
technology for the synthesis of discrete, compact clusters of
gadolinium chelates to increase the signal from a single
targeting molecule. This involves the use of both chemistry and
biophysics to maintain the signal-enhancing effect.
Product Candidates Under Development
EPIXs lead product candidate, Vasovist, is an injectable
intravascular contrast agent designed to provide visual imaging
of the vascular system through MRA. EPIX believes that
Vasovist-enhanced MRA has the potential to improve the diagnosis
of multiple diseases of the vascular system, including vascular
disease outside the heart and diseases that affect the coronary
arteries and reduce blood flow to the heart. EPIXs initial
target indication for Vasovist is for use in MRA imaging of
non-coronary vascular disease.
In December 2003, EPIX submitted an NDA for Vasovist to the FDA
and in June 2004, EPIXs development partner Schering AG
submitted a Marketing Authorization Application, or MAA, to the
EMEA. In January 2005, EPIX received an approvable letter from
the FDA for Vasovist in which the FDA requested additional
clinical trials prior to approval. In May 2005, EPIX submitted a
response to the FDA approvable letter, which was accepted by the
FDA as a complete response in June 2005. In November 2005, the
FDA provided EPIX with a second approvable letter. The second
approvable letter indicated that at least one additional
clinical trial and a re-read of images obtained in certain
previously completed Phase III trials will be necessary
before the FDA could approve Vasovist. EPIX believes that these
trials would require a substantial period of time to complete.
No safety or manufacturing issues were raised in the second
approvable letter. EPIX had a meeting with the FDA in January
2006 and April 2006 to discuss the path forward for Vasovist in
the United States and EPIX is currently considering all of its
options, including formally appealing the FDAs decision to
require an additional clinical trial and/or conducting one or
more additional clinical trials.
EPIX believes that Vasovist will significantly enhance the
quality of MRI images and provide physicians with a
minimally-invasive and cost-effective method for diagnosing
vascular disease. EPIX also
128
believes that Vasovist-enhanced MRA has the potential to
simplify the diagnosis of vascular disease. EPIX believes that
Vasovist-enhanced MRA will be a less invasive method of imaging
a patients vascular anatomy for the evaluation of disease.
The NDA EPIX submitted to the FDA for Vasovist is primarily
based on a 780-patient
Phase III clinical trial program designed to test the
safety and efficacy of Vasovist for the imaging of peripheral
vascular disease. Four Phase III trials were conducted to
determine the efficacy of Vasovist-enhanced MRA for the
detection of vascular disease in the peripheral arterial system,
including the aorta, iliac and femoral arteries of the legs,
lower abdomen and pelvic regions, as well as in the renal
arteries of the kidneys and in the pedal arteries of the feet.
EPIX believes all four trials in the Phase III program for
Vasovist met their prospectively-defined primary endpoints as
specified in the clinical trial protocols. EPIX believes that an
important feature of Vasovist is that it yielded a minimal
number of uninterpretable MRA images in the Phase III
trials, while non-contrast MRA produced a significantly higher
rate of uninterpretable images.
In both approvable letters related to the NDA for Vasovist, the
FDA indicated that its principal questions surrounding the
efficacy of Vasovist relate to the non-contrast MRA comparator
scans used in the Phase III trials and to the statistical
treatment of uninterpretable scans. The Vasovist Phase III
clinical trial protocol required investigators to use their
institutional standard medical imaging practice for acquiring
non-contrast MRA comparator scans at each site. The FDA
expressed concern that a uniform non-contrast MRA imaging method
was not used by all sites. The FDA requested, and EPIX provided,
a series of analyses showing alternative statistical treatment
of uninterpretable scans in the calculation of the sensitivity
and specificity of both non-contrast and Vasovist-enhanced MRA
imaging methods in the Phase III trials. Eliminating the
effects of uninterpretable scans completely from the sensitivity
and specificity statistical calculation reduces the resultant
efficacy improvements for Vasovist over non-contrast MRA
reported in the Phase III trials.
In October 2005, the EMEA granted approval of Vasovist for all
25 member states of the E.U. Schering AG, EPIXs partner
for Vasovist, began marketing Vasovist in the Netherlands in
April 2006 and EPIX expects that Schering AG will begin
marketing Vasovist in additional countries in Europe.
EPIX is developing a second targeted contrast agent, EP-2104R,
which is designed to illuminate and identify blood clots using
MRI. Finding blood clots is of critical medical significance in
the evaluation and diagnosis of patients with stroke, chest
pain, heart attack, irregular heartbeat and clots in the lungs
and legs. EPIX designed EP-2104R to bind reversibly to fibrin,
the dominant protein found in clots. In pre-clinical studies,
EP-2104R has been shown to enhance the ability of MRI to image
clots throughout the vascular system. In 2004, EPIX completed
Phase I clinical trials of EP-2104R in which the drug was
well-tolerated in healthy volunteers.
EP-2104R entered Phase II clinical trials in April 2005. In
July 2005, EPIX announced that it would be amending its
Phase II
proof-of-concept
clinical trial protocols for EP-2104R to include additional
patient safety monitoring based on observations by the FDA of
data from a 14-day,
repeat dose pre-clinical toxicology study. EPIX believes that
the observations, which were evident in both treated and
untreated groups, are not related to EP-2104R. The additional
patient monitoring in the Phase II trials extended the
timeline and increased the cost for EP-2104R development. These
trials completed enrollment in the first quarter of 2006.
EPIX is encouraged by the quality of images it has seen in its
Phase II trial and accordingly, EPIX has asked Schering AG
to exercise its option to license to develop and market
EP-2104R. The option, which would include payments to EPIX on
the exercise of the option as well as based upon achievement of
milestones and royalty payments based on future sales, is
exercisable for a specified period which commences on the
provision to Schering AG of a trial report following the
conclusion of the Phase II clinical trial. If Schering AG
declines to exercise the option, the rights to EP-2104R would
revert to EPIX.
129
Use of Vasovist with MRI and MRA Technology
EPIX believes that there is significant clinical need for an
FDA-approved highly accurate, minimally-invasive technology that
can enhance MRI and that provides more comprehensive diagnostic
information about the vascular system. EPIX believes that
Vasovist-enhanced MRA may facilitate several clinically valuable
diagnostic procedures, particularly in diagnosing vascular
disease.
MRI is the imaging technology of choice for a broad range of
applications, including brain tumors, knee injuries and
disorders of the head, neck and spine. The use of MRI has grown
steadily over the past 10 years in part due to its broader
availability, improved imaging capabilities and the lack of
radiation exposure to the patient. MRI is performed by placing a
portion of the patients body in a magnetic field and
applying safe, low-energy radio waves. The different organs and
tissues in the body respond uniquely to the electromagnetic
field within the MRI scanner, and these responses can be
captured and converted into high-resolution three-dimensional
images. When a contrast agent is used, it is injected into a
vein in the patients arm prior to an MRI exam to amplify
the signal from the anatomical structure that is being imaged.
MRI scanners are characterized by the strength of the magnetic
field they generate. Typical MRI scanners, those most commonly
found in hospitals, generate a relatively strong magnetic field
and therefore require significant infrastructure for
installation. Low-field scanners, whose magnetic fields are less
than one-third the strength of traditional scanners, are often
found in non-hospital settings due to their relatively low cost
and infrastructure requirements. The trade-off for low-field MRI
scanners is that a decrease in the strength of the magnetic
field results in a decrease in the MRI signal detected, which
typically results in reduced image quality.
While MRI is currently used extensively to image many organs and
tissues in the body, its use in imaging the vascular system has
been limited. Currently-available MRI contrast agents are not
optimal for imaging many vascular beds due to the rapid leakage
of the injectable contrast agent from the vascular system into
the surrounding tissue as well as rapid excretion from the body,
resulting in only approximately 30 to 60 seconds for the imaging
of a limited vascular area. As a result of this rapid clearance
from the vascular system, the time available to image blood
vessels with these contrast agents is too short to obtain the
high resolution images of multiple vascular regions desired for
broad clinical application. In addition, performance of MRA
using currently approved contrast agents generally requires
specialized equipment and specially trained staff. None of the
currently available MRI contrast agents are approved by the FDA
for use in MRA.
While the use of MRA is expanding among experts, its major
application has been in the head and neck and it has not had a
significant impact on the diagnosis of vascular disease to date,
with the exception of arterial studies of the head and neck.
Non-contrast MRA exams of the vascular system, which image blood
flow, are often ineffective when used in patients with vascular
disease because of the minimal blood flow or turbulent blood
flow associated with this condition. Even for the imaging of the
carotid arteries in the neck, where non-contrast, flow-based MRA
has had some clinical impact, the lack of direct anatomic data
limits the ability of MRA to provide a quantitative measurement
of stenosis required for accurate diagnosis. MRA exams using
existing general-use contrast agents are limited by the rapid
diffusion of the agents out of the vascular system, which
reduces the time during which an image can be acquired.
Consequently, many experts believe MRI contrast agents that
remain in the bloodstream for extended periods of time will be
necessary to attain widespread use of MRI to image the vascular
system.
Vasovist is specifically designed to improve the quality of
magnetic resonance images of the arteries and veins and to
provide physicians with a high resolution method for diagnosing
vascular disease. Vasovist is a small molecule that produces an
MRI signal because of the presence of gadolinium, a magnetically
active element favored by clinicians for enhancing magnetic
resonance images. Using standard MRI techniques,
Vasovist-enhanced MRA produces a strong magnetic signal,
resulting in bright images of the blood against the dark
background of surrounding tissue. Because of its affinity for
serum albumin, Vasovist remains at high concentrations in the
bloodstream throughout an MRI exam, providing the extended
period, approximately 60-minutes, of imaging time and signal
strength required to obtain a high
130
resolution image of multiple regions of the vascular system.
Like most currently available general use MRI contrast agents,
Vasovist is designed to be safely eliminated from the body
through the kidneys over time. In clinical trials of
renally-compromised patients, Vasovist appeared safe and well
tolerated, a potentially important feature given the inherent
risks of X-ray contrast agents used in X-ray angiography.
EPIX believes that Vasovist, by providing a longer imaging
window, allowing visualization of multiple arterial beds and
making MRA easier to perform, has the potential to become the
preferred contrast agent for a significant portion of MRAs
currently performed with general use contrast agents. Unlike
most currently available general use MRI contrast agents, which
are non-specific and rapidly clear out of the arteries and
veins, Vasovist is designed to bind reversibly to albumin, the
most common protein in the blood. Because of its affinity for
albumin, Vasovist has an enhanced effect on the magnetic
properties of the blood and remains at relatively stable
concentrations in the bloodstream throughout the MRI exam and,
therefore, provides the image acquisition time and signal
strength needed to obtain high resolution images of the vascular
system. These images are intended to provide sufficient
anatomical detail for definitive diagnosis and surgical
planning. Accordingly, EPIX believes that Vasovist-enhanced MRA
has the potential to replace a significant portion of the
conventional diagnostic X-ray angiograms performed each year.
Atherosclerosis is one of the most common forms of vascular
disease. This condition refers to the accumulation of fatty
plaques in the inner lining of blood vessels, resulting in a
thickening of affected vessels. As the disease progresses, the
arteries can become weakened or increasingly narrowed, thereby
reducing blood flow to vital organs, including the heart and
brain. Clinicians have also begun to realize the importance of
characterizing atherosclerotic plaques once they have been
identified. Even in arteries where significant narrowing has not
yet occurred, vulnerable plaques may rupture, causing a blood
clot to form, which can result in heart attack, stroke and
death. EPIX believes that the ability to characterize plaques
may allow physicians to identify those regions of vascular
disease that present the most immediate threat to patients
health and that Vasovist will aid in the evaluation of the
disease.
EPIX believes that Vasovist, coupled with anticipated advances
in software and hardware for MRI equipment, will enable
physicians to use MRI to perform a minimally-invasive,
integrated cardiac exam for the diagnosis of coronary artery
disease. Such a procedure would be designed to provide
information on coronary artery anatomy, including location of
arterial blockages as well as cardiac perfusion and cardiac
function data, in one sitting early in the diagnostic work-up.
Because the procedure is intended to provide physicians with
more comprehensive diagnostic information at an earlier stage of
the diagnostic work-up, physicians would be able to make a more
informed diagnosis and therefore arrange for appropriate patient
treatment sooner than would otherwise be possible, thereby
potentially achieving better patient outcomes at a lower cost.
EPIX believes that over half of the patients in the United
States who enter the diagnostic pathway for coronary artery
disease each year could be candidates for such an integrated
cardiac exam.
EPIX believes Vasovist-enhanced MRA will find significant
clinical utility beyond the diagnosis of vascular disease.
Because of its potential for high-resolution imaging of the
vasculature, Vasovist may be useful in diagnosing several
conditions involving damaged or abnormal microvessels, such as
cancer. In addition, as it is targeted to albumin,
Vasovist-enhanced MRA may play a role in diagnosing conditions
which result in regions of atypical albumin concentration, such
as inflammation due to infection or due to rheumatoid diseases,
such as arthritis or lupus.
Strategic Alliances and Collaborations
In June 2000, EPIX entered into a strategic collaboration
agreement for Vasovist pursuant to which EPIX granted Schering
AG an exclusive license to co-develop and market Vasovist
worldwide, excluding Japan. In December 2000, EPIX amended this
strategic collaboration agreement to grant to Schering AG the
exclusive rights to develop and market Vasovist in Japan.
Generally, each party to the agreement will share equally in
Vasovist costs and profits. Under the agreement, EPIX will
assume responsibility for completing clinical trials and filing
for FDA approval in the United States and Schering AG will lead
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clinical and regulatory activities for the product outside the
United States. In addition, EPIX granted Schering AG an
exclusive option to develop and market an unspecified vascular
MRI blood pool agent from EPIXs product pipeline. In
connection with this strategic collaboration and the amendment
to EPIXs strategic collaboration agreement with Tyco/
Mallinckrodt, as further described below, Schering AG paid EPIX
an up-front fee of $10.0 million, which EPIX then paid to
Tyco/ Mallinckrodt. Under the agreement, Schering AG also paid
EPIX $20.0 million in exchange for shares of EPIXs
common stock through its affiliate, Schering AG Berlin Venture
Corporation, or Schering AG BV. EPIX may receive up to an
additional $28.8 million in milestone payments under the
strategic collaboration agreement, of which $5.5 million
has been paid to date and up to an additional $1.3 million
may be earned upon U.S. product approval. Following
commercial launch of Vasovist, EPIX will also be entitled to
receive a royalty on products sold outside the United States and
a percentage of Schering AGs operating profit margin on
products sold in the United States.
Also, under the strategic collaboration agreement with Schering
AG, EPIX has options to acquire certain participation rights
with respect to two of Schering AGs MRI imaging products
currently in clinical trials, SHU555C and Gadomer. EPIX is
entitled to exercise these options on a region-by-region basis
upon the payment of certain fees. If EPIX exercises the SHU555C
option, it will enter into a definitive agreement with Schering
AG with respect to SHU555C, pursuant to which Schering AG will
be responsible for the conduct of all development, marketing and
sales activities in connection with SHU555C. If EPIX exercises
the Gadomer option, its will enter into a definitive agreement
with Schering AG with respect to Gadomer, pursuant to which EPIX
will share development costs incurred from the date of the
option exercise, as well as profits, equally with Schering AG
and EPIX will be obligated to make milestone payments to
Schering AG.
Under the terms of the strategic collaboration agreement for
Vasovist, either party may terminate the agreement upon thirty
days notice if there is a material breach of the contract or if
either party fails to meet certain milestones. In addition,
Schering AG may terminate the agreement at any time on a
region-by-region basis or in its entirety, upon six months
written notice to EPIX; and EPIX may terminate the agreement
with respect to development of Vasovist in the E.U. at any time
upon 90 days written notice to Schering AG, if Schering AG
has failed to meet its obligations in connection with the
regulatory approval of Vasovist in the E.U.
In May 2003, EPIX announced a broad alliance with Schering AG
for the discovery, development and commercialization of
molecularly-targeted contrast agents for MRI. The alliance is
composed of two areas of collaboration, with one agreement
providing for exclusive development and commercialization
collaboration for EP-2104R, EPIXs product candidate for
the detection of thrombus, as well as any other product
candidate that EPIX and Schering AG determine to develop for
detection of thrombus using MRI, and the second agreement
covering an exclusive research collaboration to discover novel
compounds for diagnosing human disease using MRI. As a result of
the alliance, Schering AG has an option to the late stage
development and worldwide marketing rights for EP-2104R, other
thrombus imaging agents and for all development candidates
emerging from the MRI research collaboration.
Under the terms of the EP-2104R agreement, EPIX is responsible
for execution of a clinical feasibility program in humans. At
the end of the feasibility program, Schering AG may exercise an
option to develop and commercialize EP-2104R under which
Schering AG will receive an exclusive, worldwide license for
EP-2104R and become responsible for all further development,
manufacturing, marketing and sales. Schering AG made fixed
payments to EPIX totaling approximately $9.0 million to
cover EPIXs expenditures in the feasibility program. In
addition, if Schering AG exercises its option to develop and
commercialize EP-2104R, Schering AG will pay EPIX up to
$15.0 million in additional payments upon the occurrence of
certain development and commercial events as well as royalties
on sales attributable to the EP-2104R development effort. The
royalty rate will depend on the level of annual net sales. In
addition to funding for EPIXs feasibility program and
milestone and base royalty payments, EPIX has the right to
increase its royalty rate by paying to Schering AG a portion of
the costs of clinical development.
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Under the terms of the MRI three-year joint research agreement,
EPIX and Schering AG have exclusively combined EPIXs
existing research programs in the field of diagnosing human
disease using MRI to discover novel MRI product candidates for
clinical development. Schering AG funds a portion of EPIXs
related personnel costs and third-party research costs of up to
$2.0 million per annum. Also under the MRI research
agreement, Schering AG has the first option to obtain exclusive,
worldwide rights for the product candidates and, upon exercising
the option, would become responsible for all future development,
manufacturing, marketing and sales. EPIX would receive a base
royalty on net sales with the option to increase the royalty by
participating in development funding. If Schering AG does not
exercise its option, EPIX may license the product to a third
party and Schering AG would receive a base royalty on net sales
and milestone payments.
In October 2005, EPIX announced that an amendment to the
research collaboration agreement had been entered into with
Schering AG. This amendment narrows the definition of the field
of EPIXs collaboration with Schering AG. This research
collaboration expires in May 2006, and EPIX believes that it is
unlikely that the parties will extend the term of the
collaboration. EPIX expects to discuss the disposition of
current research programs with Schering AG prior to expiration
of the collaboration and to continue to advance at least some of
these programs either unilaterally or with another partner.
In May 2003, EPIX entered into a loan agreement with Schering AG
which entitled EPIX to borrow up to $15.0 million from time
to time. EPIX repaid the loan in full in October 2005 and in
January 2006, it terminated the loan agreement with Schering AG.
On May 8, 2000, EPIX granted to Schering AG a worldwide,
royalty-bearing license to patents covering Schering AGs
development project, Primovist, an MRI contrast agent for
imaging the liver, approved in the E.U. in 2004. Also on
May 8, 2000, Schering AG granted EPIX a non-exclusive,
royalty-bearing license to certain of its Japanese patents. EPIX
agreed to withdraw its invalidation claim of Schering AGs
Japanese patent 1,932,626 in the Japanese Patent Office pursuant
to this license agreement. See Contractual Disputes
for a further discussion of this license agreement. Schering AG
had been an opposing party in EPIXs European patent case
prior to the licensing agreement. On May 9, 2000, the
Opposition Division of the European Patent Office maintained
EPIXs European patent in a slightly amended form. The
patent is owned by Massachusetts General Hospital, or MGH, and
is exclusively licensed to EPIX. The remaining opposing parties
initially elected to appeal the May 9, 2000 decision.
However, in September 2001, EPIX settled this patent dispute
with the opposing parties by entering into a non-exclusive
royalty bearing license agreement with Bracco. See
Contractual Disputes for further discussion of this
settlement.
In June 2000, in connection with the exclusive license that EPIX
granted to Schering AG, EPIX amended its strategic collaboration
with Tyco/ Mallinckrodt to grant Tyco/ Mallinckrodt a
non-exclusive, worldwide license to manufacture Vasovist for
clinical development and commercial use in accordance with a
manufacturing agreement entered into in June 2000 between Tyco/
Mallinckrodt and Schering AG, and to enable EPIX to enter into
the strategic collaboration agreement with Schering AG described
above. In connection with this amendment, EPIX paid Tyco/
Mallinckrodt an up-front fee of $10.0 million and is
obligated to pay up to an additional $5.0 million in
milestone payments, of which $2.5 million was paid
following NDA filing in February 2004 and $2.5 million will
be paid upon U.S. product approval. EPIX will also pay
Tyco/ Mallinckrodt a share of its Vasovist operating profit
margins in the United States. and a percentage of the royalty
that EPIX receives from Schering AG on Vasovist gross profits
outside the United States.
In March 1996, EPIX entered into a development and license
agreement with Daiichi pursuant to which EPIX granted Daiichi an
exclusive license to develop and commercialize Vasovist in
Japan. Under this arrangement, Daiichi assumed primary
responsibility for clinical development, regulatory approval,
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marketing and distribution of Vasovist in Japan. EPIX retained
the right and obligation to manufacture Vasovist for development
activities and commercial sale under the agreement. In December
2000, EPIX reacquired the rights to develop and commercialize
Vasovist in Japan from Daiichi. Under the terms of this
reacquisition agreement with Daiichi, EPIX agreed to pay Daiichi
a total amount of $5.2 million, of which EPIX paid
$2.8 million in January 2001 and $2.4 million in
December 2003. Daiichi will also receive a royalty from EPIX
based on net sales of Vasovist in Japan. Simultaneously with
EPIXs reacquisition from Daiichi of the Vasovist
development and marketing rights in Japan, EPIX assigned these
rights to Schering AG as described above.
EPIX entered into a collaboration agreement in 1997 and two
further collaboration and license agreements in November 2004
with Dyax Corp., or Dyax, for research relating to EPIXs
thrombus program and other research programs. Under the terms of
the thrombus program agreements with Dyax, EPIX has exclusive
worldwide rights to develop and commercialize ligands and
derivatives of fibrin-binding peptides discovered during the
research collaboration with Dyax. These rights include both an
exclusive license to diagnostic imaging compounds (excluding
radiopharmaceuticals) as well as therapeutic compounds. In
return for these exclusive license rights, EPIX agreed to pay
Dyax certain specified research related payments, milestone
payments and royalties upon commercialization of certain
products arising from the these programs.
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Massachusetts General Hospital |
EPIX has entered into a license agreement with MGH pursuant to
which MGH has granted EPIX an exclusive worldwide license to the
patents and patent applications which relate to Vasovist. The
MGH license imposed certain due diligence obligations with
respect to the development of products covered by the license,
all of which have been fulfilled to date. The MGH license
requires EPIX to pay royalties on its net sales of Vasovist
through 2006. EPIX must also pay MGH a percentage of all
royalties received from EPIXs sublicensees until 2006 or
later on any sublicense if the MGH patents related to that
sublicense are extended. EPIX believes that the expiration of
these patents does not compromise its proprietary position with
respect to Vasovist.
In November 2003, EPIX entered into an intellectual property
agreement with Dr. Martin R. Prince, an early innovator in
the field of MRA relating to dynamic MRA, which
involves capturing MRA images during the limited time, typically
30 to 60 seconds, available for imaging with extracellular
agents. Under the terms of the intellectual property agreement,
Dr. Prince made certain covenants and agreements and
granted EPIX certain discharges, licenses and releases in
connection with the use of Vasovist. In consideration of
Dr. Prince entering into the agreement, EPIX agreed to pay
him an upfront fee and royalties on sales of Vasovist consistent
with a non-exclusive early stage academic license and agreed to
deliver to him 132,000 shares of EPIXs common stock
and certain quantities of Vasovist.
Competition
The healthcare industry is characterized by extensive research
efforts and rapid technological change and there are several
companies that are working to develop products similar to
EPIXs products. However, there are a number of general use
MRI agents approved for marketing in the United States and in
certain foreign markets that, if used or developed for MRA, are
likely to compete with Vasovist. Such products include Magnevist
and Gadovist by Schering AG, Dotarem by Guerbet, S.A., Omniscan
by GE Healthcare, ProHance and MultiHance by Bracco and OptiMARK
by Tyco/ Mallinckrodt. EPIX is aware of five agents under
clinical development that have been or are being evaluated for
use in MRA: Schering AGs Gadomer and SHU555C,
Guerbets Vistarem, Braccos B-22956/1,
Ferropharms Code VSOP-C184, and Advanced Magnetics
Ferumoxytol. EPIX is aware of no MRI contrast agent other than
EPIXs prototype being developed for use in imaging blood
clots. EPIX cannot assure you that its competitors will
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not succeed in the future in developing products that are more
effective than any that EPIX is developing. EPIX believes that
its ability to compete in developing MRI contrast agents depends
on a number of factors, including the success and timeliness
with which it completes FDA trials, the breadth of applications,
if any, for which its products receive approval, and the
effectiveness, cost, safety and ease of use of its products in
comparison to the products of its competitors.
In addition to competition within the MRI field, EPIX also faces
competition from other imaging technologies, including CT scans,
ultrasounds, and X-ray scans. EPIX success will depend on
physician acceptance of MRI as a primary imaging modality for
certain vascular and other applications.
Patents and Proprietary Rights
EPIX considers the protection of its proprietary technologies to
be material to its business prospects. EPIX pursues a
comprehensive patent program in the United States and in other
countries where it believes that significant market
opportunities exist.
EPIX owns or has exclusively licensed patents and patent
applications related to its core technologies. EPIXs
patents and patent applications relating to its technology
include the following:
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Two U.S. patents exclusively licensed from MGH which expire
in 2006 (U.S. Patents 4,899,755 and 4,880,008) as well as
their cognate patents in certain foreign countries, including
EPO 222,886. These patents generally relate to MRI signal
generation technology, albumin binding with metal chelates and
liver targeting metal chelates. |
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Eleven U.S. patents owned by EPIX as well as their cognate
patents and applications in certain foreign countries: |
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U.S. Patent 5,582,814, Contrast Agents for Diagnostic
Imaging (granted December 10, 1996; expires
April 15, 2014); |
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U.S. Patent 5,919,967, Process for Synthesizing
Phosphodiesters (granted July 6, 1999; expires
April 11, 2017); |
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U.S. Patent 6,548,044, Imaging Sexual Response
(granted April 15, 2003; expires November 21, 2020); |
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U.S. Patent 6,549,798, Magnetic Resonance Angiography
Data (granted April 15, 2003; expires
February 7, 2021); |
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U.S. Patent 6,652,835, Targeting Multimeric Imaging
Agents Through Multilocus Binding (granted
November 25, 2003; expires July 28, 2020); |
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U.S. Patent 6,676,929, Diagnostic Imaging Contrast
Agents With Extended Blood Retention (granted
January 13, 2004; expires February 1, 2015; however,
the USPTO has indicated that the patent is entitled to
114 days of patent term adjustment); |
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U.S. Patent 6,709,646, Bioactivated Diagnostic
Imaging Contrast Agents (granted March 23, 2004;
expires March 25, 2017; however, the USPTO has indicated
that the patent is entitled to 99 days of patent term
adjustment); |
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U.S. Patent 6,861,045, Contrast-enhanced diagnostic
imaging method for monitoring interventional therapies
(granted March 1, 2005; expires October 2, 2017;
however the USPTO has indicated that the patent is entitled to
424 days of patent term adjustment); |
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U.S. Patent 6,925,321, Magnetic Resonance Angiography
Data (granted August 2, 2005; expires
February 7, 2021); |
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U.S. Patent 6,969,507, Imaging Sexual Response
(granted November 29, 2005; expires November 21, 2020;
however the USPTO has indicated that the patent is entitled to
117 days of patent term adjustment); |
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U.S. Patent 6,991,775, Peptide-based multimeric
targeted contrast agents (granted January 31, 2006;
expires July 30, 2022); and |
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Nineteen U.S. utility applications in prosecution as well
as their cognate applications in certain foreign countries and
six provisional utility applications. Some of these relate to
MRI, Vasovist and methods of use, EP-2104R and methods of use,
and others to therapeutics and methods of use. |
Some of EPIXs patents related to Vasovist will expire in
2006 in the United States and Europe. Other patents related to
Vasovist will not expire until 2015. Protection for Vasovist
manufacturing processes in the United States will not expire
until 2017. Patents related to certain methods of using Vasovist
will not expire until 2021. EPIX plans to apply for patent term
extension on one of the patents or patent applications described
above under the Hatch/Waxman provisions, which may extend the
term of EPIXs patent protection.
A patent related to EP-2104R will not expire until 2022. If all
of EPIXs pending patent applications issue with claims
substantially similar to those currently set forth in such
applications, further patent protection for EP-2104R may not
expire until 2022.
Contractual Disputes
EPIX has received various payments, including royalties on a
quarterly basis, pursuant to a license with Bracco. In December
2004, EPIX learned from Bracco that Bracco was asserting that it
had overstated
non-U.S. royalties
to EPIX for the period 2001 to 2004 and that it would offset the
amount of the overstatement against its royalty payments to
EPIX, including those triggered by FDA approval of MultiHance in
the United States. EPIX has challenged Braccos
underpayment, its right to recalculate previous royalties under
EPIXs license agreement and the substance of its
restatements and are in discussions with Bracco regarding the
resolution of this dispute.
On May 8, 2000, EPIX granted to Schering AG a worldwide
royalty-bearing license to EPIXs patents covering Schering
AGs development project, Primovist, an MRI contrast agent
for imaging the liver, approved in the E.U. in 2004. Also on
May 8, 2000, Schering AG granted EPIX a non-exclusive
royalty-bearing license to its Japanese Patent Nos. 1,932,626
and 1,968,413, and its Japanese Application corresponding to PCT
Intl. Pub. No. WO99/16474. EPIX has agreed to withdraw its
invalidation claim of Schering AGs Japanese Patent
No. 1,932,626 in the Japanese Patent Office pursuant to
this license agreement. As a result of the settlement and
license agreements with Bracco and Schering AG, apart from
EPIXs royalty dispute with Bracco, EPIX is not aware of
any legal actions involving this patent family.
Manufacturing
EPIX does not have, nor does it currently have plans to develop,
full-scale manufacturing capability for Vasovist. Schering AG is
responsible for the manufacture of Vasovist. Schering AG relies
on Tyco/ Mallinckrodt as the sole manufacturer of Vasovist for
human clinical trials and commercial use. Together with Schering
AG, EPIX is considering alternative manufacturing arrangements
for Vasovist for commercial use, including the transfer of
manufacturing to Schering AG. In the event that Tyco/
Mallinckrodt fails to fulfill its manufacturing responsibilities
satisfactorily, Schering AG has the right to purchase Vasovist
from a third party or to manufacture the compound itself.
Government Regulation
The manufacture and commercial distribution of pharmaceuticals
are subject to extensive governmental regulation in the United
States and other countries. Pharmaceuticals, including
contrast-imaging agents for use with MRI, are regulated in the
United States by the FDA under the Food, Drug and Cosmetic Act,
or FD&C Act, and require FDA approval prior to commercial
distribution. Pursuant to the FD&C Act, pharmaceutical
manufacturers and distributors must be registered with the FDA
and are subject to ongoing FDA regulation, including periodic
FDA inspection of their facilities and review of their
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operating procedures. Both before and after approval,
noncompliance with applicable requirements can result in failure
to receive approval, withdrawal of approval, total or partial
suspension of production, fines, injunctions, civil penalties,
recalls or seizure of products and criminal prosecution, each of
which would have a material adverse effect on EPIXs
business, financial conditions and results of operations.
In order to undertake clinical trials and market pharmaceutical
products for diagnostic or therapeutic use in humans, the
procedures and safety standards established by the FDA and
comparable agencies in foreign countries must be followed. In
the United States, a company seeking approval to market a new
pharmaceutical must obtain FDA approval of an NDA. The steps
required before a drug may be marketed in the United States
include:
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performance of pre-clinical laboratory and animal studies; |
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submission to the FDA of an application for an investigational
new drug application, or IND, which must become effective before
human clinical trials may commence; |
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completion of adequate and well-controlled human clinical trials
to establish the safety and efficacy of the pharmaceutical for
its intended use; |
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submission to the FDA of an NDA; |
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satisfactory completion of an FDA inspection of the
manufacturing facility or facilities at which the drug is
produced to assess compliance; and |
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FDA review and approval of the NDA. |
Pre-clinical studies include laboratory evaluation of product
chemistry and animal studies to assess the potential safety and
efficacy of the product and its formulation. The results of the
pre-clinical studies and the protocol for the proposed clinical
trial are submitted to the FDA as part of an IND. An IND
automatically becomes effective 30 days after receipt by
the FDA, unless before that time the FDA raises concerns or
questions about issues such as the conduct of the clinical
trials outlined in the IND. In that case, the IND is placed on
clinical hold and the sponsor and the FDA must resolve any
outstanding FDA concerns or questions before clinical trials can
proceed. Clinical trials are conducted in accordance with
protocols that detail the objectives of the study, the
parameters to be used to monitor safety and the efficacy
criteria to be evaluated. Each protocol together with
information about the clinical investigators who will perform
the studies and the institutions at which the trials will be
performed are submitted to the FDA as part of the IND.
An independent institutional review board, or IRB, at each
institution at which the trial will be conducted will also be
asked by the principal investigator at that institution to
approve, according to FDA regulations governing IRBs, the trials
that will be performed at that institution. The IRB will
consider, among other things, ethical factors, the protection of
human subjects and the possible liability of the institution and
the adequacy of the informed consent.
Clinical trials under the IND are typically conducted in three
sequential phases, but the phases may overlap. In Phase I,
the initial introduction of the pharmaceutical into humans, the
pharmaceutical is tested for safety, dosage tolerance,
metabolism, distribution, excretion and clinical pharmacology in
healthy adult subjects. Imaging agents may also be subject to
additional Phase I trials under which an agents
imaging characteristics in humans are first evaluated.
Phase II involves a detailed evaluation of the safety and
efficacy of the agent in a range of doses in patients with the
disease or condition being studied. Phase III clinical
trials typically consist of evaluation of safety and efficacy in
a larger patient population and at more institutions.
Assuming successful completion of the required clinical testing,
the results of the pre-clinical studies and clinical trials,
together with other detailed information, including information
on the manufacture of the drug, are submitted to the FDA in the
form of a new drug application, or NDA, requesting approval to
market the product for one or more indications. During the
review period for the NDA, an FDA advisory committee may be
asked to review and evaluate the application and provide
recommendations to the FDA
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about approval of the pharmaceutical. In addition, the FDA will
usually inspect the facility at which the pharmaceutical is
manufactured to assess compliance with current good
manufacturing practices, or cGMP, and other applicable
regulations. Failure of a manufacturer to comply or come into
compliance with cGMP requirements could significantly delay FDA
approval of the NDA.
After an NDA is approved, a company would continue to be subject
to pervasive and continuing regulation by the FDA, including
record keeping requirements, reporting of adverse experience
from the use of the agent, restrictions on promotion and
advertising and other requirements imposed by the FDA. FDA
regulations also require FDA approval of an NDA supplement for
certain changes if they affect the safety and efficacy of the
pharmaceutical, including, but not limited to, new indications
for use, labeling changes, the use of a different facility to
manufacture, process or package the product, changes in
manufacturing methods or quality control systems and changes in
specifications for the product. If the FDA determines that the
NDA and the manufacturing facilities are acceptable, the FDA
will issue an approval letter. If the FDA determines the
application or manufacturing facilities are not acceptable, the
FDA will outline the deficiencies in the submission and often
will request additional testing or information. Notwithstanding
the submission of any requested information, the FDA ultimately
may decide that the NDA does not satisfy the regulatory criteria
for approval. EPIXs failure to receive approval of an NDA
supplement could have a material adverse effect on its business,
financial condition and results of operations.
EPIX is and may be subject to regulations under state and
federal law regarding occupational safety, laboratory practices,
handling of chemicals, environmental protection and hazardous
substance control. EPIX also will be subject to existing present
and possible future local, state, federal and foreign
regulation. Approval and marketing of pharmaceutical products
outside of the United States are subject to regulatory
requirements that vary widely from country to country. The time
required to obtain regulatory approval from comparable
regulatory agencies in each foreign country may be longer or
shorter than that required for FDA approval. In addition, in
certain foreign markets EPIX may be subject to governmentally
mandated prices for its products.
Regulations regarding the approval, manufacture and sale of
EPIXs product candidates are subject to change. EPIX
cannot predict what impact, if any, such changes might have on
its business, financial condition or results of operations.
EPIXs research, development and manufacturing processes
require the use of hazardous substances and testing on certain
laboratory animals. As a result, EPIX is also subject to
federal, state, and local laws, regulations and policies
governing the use, generation, manufacture, storage, air
emission, effluent discharge, handling and disposal of certain
materials and waste as well as the use of and care of laboratory
animals. These laws and regulations are all subject to change.
EPIX cannot predict what impact, if any, such changes might have
on its business, financial condition or results of operations.
Reimbursement
EPIX expects that sales volumes and prices of its products will
be dependent in large measure on the availability of
reimbursement from third-party payors and that individuals
seldom would be willing or able to pay directly for all the
costs associated with procedures which in the future may
incorporate the use of EPIXs products. EPIX expects that
when approved for sale in the United States, its products will
be purchased by hospitals, clinics, doctors and other users that
bill various third-party payors, such as Medicare, Medicaid and
other government insurance programs, and private payors
including indemnity insurers, Blue Cross Blue Shield plans and
managed care organizations, or MCOs, such as health maintenance
organizations. Most of these third-party payors provide coverage
for MRI for some indications when it is medically necessary, but
the amount that a third-party payor will pay for MRI may not
include a separate payment for a contrast imaging agent that is
used with MRI. Reimbursement rates vary depending on the
procedure performed, the third-party payor, the type of
insurance plan and other factors.
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Many third-party payors in the United States, including
governmental payors such as the Centers for Medicare and
Medicaid Services, or CMS, carefully review and increasingly
challenge the prices charged for procedures and medical
products. In the past few years, the amounts paid for radiology
procedures in particular have come under careful scrutiny and
have been subject to decreasing reimbursement rates.
In foreign markets, reimbursement is obtained from a variety of
sources, including governmental authorities, private health
insurance plans and labor unions. In most foreign countries,
there are also private insurance systems that may offer payments
for alternative therapies. Although not as prevalent as in the
United States, health maintenance organizations are emerging in
certain European countries.
With respect to certain of EPIXs products, including
Vasovist and, should Schering AG exercise its license option,
EP-2104R, Schering AG is responsible for obtaining and
maintaining reimbursement.
Employees
As of March 31, 2006, EPIX employed approximately 49
persons on a full-time basis. EPIX believes that its relations
are good with its employees. None of EPIXs employees are a
party to a collective bargaining agreement. On December 31,
2005, EPIX employed approximately 96 persons on a full-time
basis, which was subsequently lowered following the reduction in
force described above.
Research and Development
During the years ended December 31, 2005, 2004 and 2003,
EPIX incurred research and development expenses of approximately
$20.8 million, $21.9 million and $28.0 million,
respectively.
Legal Proceedings
From time to time in the ordinary course of business, EPIX is
subject to various claims, charges and litigation. In January
2005, a securities class action was filed in U.S. District
Court for the District of Massachusetts against EPIX and certain
of its officers on behalf of persons who purchased EPIX common
stock between July 10, 2003 and January 14, 2005. The
complaint alleged that EPIX and the other defendants violated
the Securities Exchange Act of 1934, as amended, by issuing a
series of materially false and misleading statements to the
market throughout the class period, which statements had the
effect of artificially inflating the market price of EPIXs
securities. In January 2006, the U.S. District Court for
the District of Massachusetts granted EPIXs Motion to
Dismiss for Failure to Prosecute the shareholder class action
lawsuit against EPIX. The dismissal without prejudice was
granted after a hearing, which dismissal does not prevent
another suit to be brought based on the same claims.
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EPIX MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion of EPIXs
financial condition and results of operations in conjunction
with EPIXs consolidated financial statements and the
related notes included elsewhere in this joint proxy statement/
prospectus. This discussion contains forward-looking statements
that involve risks and uncertainties. As a result of many
factors, including those set forth under the section entitled
Risk Factors and elsewhere in this joint proxy
statement/ prospectus, EPIXs actual results may differ
materially from those anticipated in these forward-looking
statements.
Overview
EPIX Pharmaceuticals, Inc. discovers and develops innovative
pharmaceuticals for imaging that are designed to transform the
diagnosis, treatment and monitoring of disease. EPIX uses
EPIXs proprietary Target Visualization
Technologytm
to create imaging agents targeted at the molecular level. These
agents are designed to enable physicians to use Magnetic
Resonance Imaging, or MRI, to obtain detailed information about
specific disease processes. MRI has been established as the
imaging technology of choice for a broad range of applications,
including the identification and diagnosis of a variety of
medical disorders. MRI is safe, relatively cost-effective and
provides three-dimensional images that enable physicians to
diagnose and manage disease in a minimally invasive manner.
EPIX is currently developing two products for use in MRI to
improve the diagnosis of multiple diseases involving the
bodys arteries and veins, collectively known as the
vascular system: Vasovist, EPIXs novel blood-pool contrast
agent for use in magnetic resonance angiography, which was
approved for marketing in all 25 member states of the E.U. in
October 2005; and EP-2104R for detecting human thrombi, or blood
clots, using MRI. EPIX has entered into various partnership
agreements with Schering AG with respect to both Vasovist and
EP-2104R. In addition, EPIX has active research programs with
respect to products for diagnostic imaging and therapeutic uses.
Critical Accounting Policies and Estimates
The discussion and analysis of EPIXs financial condition
and results of operations is based on EPIXs financial
statements, which have been prepared in accordance with
accounting principles generally accepted in the United States.
The preparation of these financial statements requires EPIX to
make estimates and judgments that affect EPIXs reported
assets and liabilities, revenues and expenses, and other
financial information. Actual results may differ significantly
from the estimates under different assumptions and conditions.
EPIXs significant accounting policies are more fully
described in Note 2 of EPIXs Financial Statements for
the year ended December 31, 2005. Not all significant
accounting policies require management to make difficult,
subjective or complex judgments or estimates. EPIX believes that
EPIXs accounting policies related to revenue recognition,
research and development and employee stock compensation, as
described below, require critical accounting estimates and
judgments.
EPIX recognizes revenues from non-refundable license fees and
milestone payments not specifically tied to a separate earnings
process ratably over the period during which EPIX has
substantial continuing obligations to perform services under the
contract. When milestone payments are specifically tied to a
separate earnings process, revenue is recognized when the
specific performance obligations associated with the payment are
completed. When the period of deferral cannot be specifically
identified from the contract, EPIX estimates the period of
deferral based upon EPIXs obligations under the contract.
EPIX continually reviews these estimates and, if any of these
estimates change, adjustments are recorded in the period in
which they become reasonably estimable. These adjustments could
have a material effect on EPIXs results of operations.
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With respect to payments received from Schering AG in connection
with the Vasovist development program, EPIX recognizes product
development revenue at the time EPIX performs research and
development activities, for which Schering AG is obligated to
reimburse us. Product development revenues from Schering AG are
recorded net of EPIXs portion of Schering AGs actual
or most recent estimate of its Vasovist research and development
costs.
EPIX recognizes product development revenue from Schering AG for
the EP-2104R feasibility program in proportion to EPIXs
actual cost incurred relative to EPIXs estimate of the
total cost of the feasibility program. As estimated total cost
to complete the program increases, revenue is adjusted
downwards, and conversely, as estimated total cost to complete
decreases, revenue is adjusted upwards. Total estimated costs of
the feasibility program are based on managements
assessment of costs to complete the program based on an
evaluation of the portion of the program completed, costs
incurred to date, planned program activities, anticipated
program timelines and the expected future costs of the program.
Adjustments to revenue are recorded if estimated costs to
complete change materially from previous periods. To the extent
that EPIXs estimated costs change materially, EPIXs
revenues recorded under this activity could be materially
affected and such change could have a material adverse effect on
EPIXs operations in future periods. During the second
quarter of 2005, EPIXs management increased its estimate
of cost to complete the feasibility program to
$16.1 million from its prior estimate. The increase in the
cost to complete the feasibility program was primarily
attributed to the additional patient safety monitoring related
to amending the Phase II
proof-of-concept
clinical trial protocols for EP-2104R announced in July 2005.
The impact of increasing the estimated cost to complete the
feasibility program resulted in a reduction in product
development revenue of approximately $1.5 million, during
the same period. During the fourth quarter of 2005, management
lowered its estimate of the cost to complete the feasibility
program from $16.1 million to $15.2 million at
December 31, 2005 as a result of increased enrollment rate
for this clinical trial. This latest reduction in the estimated
total cost of the feasibility program resulted in an increase in
product development revenue of $449,944, which was recognized in
the fourth quarter of 2005.
Revenue under EPIXs research collaboration with Schering
AG is recognized as services are provided, for which Schering AG
is obligated to reimburse us.
Royalty revenue is recognized based on actual revenues reported
to EPIX by Bracco, and Schering AG. Prior to the fourth quarter
of 2004, EPIX recognized royalty revenue based on royalty
reports received from Bracco or on Braccos estimates,
historical revenues and trends when royalty reports from Bracco
were not available in a timely manner. In December 2004, EPIX
was notified that Bracco was asserting that it had overstated
its
non-U.S. royalties
to EPIX for the period 2001 to 2004, and that Bracco would
offset the amount of the overstatement against its payments to
us, including those triggered by FDA approval of MultiHance in
the United States. Although EPIX is disputing Braccos
position regarding the overstatement, EPIX recognized the impact
of Braccos claimed overstatement by reducing EPIXs
2004 royalty revenue. In addition, because EPIX no longer
believes that EPIX have a reasonable basis to make royalty
estimates under the agreement with Bracco, EPIX has, commencing
in the fourth quarter of 2004, only recognized royalty revenue
from Bracco in the period in which royalty reports are received.
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Research and Development Expenses |
Research and development costs, including those associated with
technology, licenses and patents, are expensed as incurred.
Research and development costs include employee salaries and
related costs, third party service costs, the costs of
pre-clinical and clinical trial supplies and consulting expenses.
In order to conduct research and development activities and
compile regulatory submissions, EPIX enters into contracts with
vendors who render services over extended periods of time,
generally one to three years. Typically, EPIX enters into three
types of vendor contracts: time-based, patient-based or a
combination thereof. Under a time-based contract, using critical
factors contained within the contract, usually the stated
duration of the contract and the timing of services provided,
EPIX records the
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contractual expense for each service provided under the contract
ratably over the period during which EPIX estimates the service
will be performed. Under a patient-based contract, EPIX first
determines an appropriate per patient cost using critical
factors contained within the contract, which include the
estimated number of patients and the total dollar value of the
contract. EPIX then records expense based upon the total number
of patients enrolled during the period. On a quarterly basis,
EPIX reviews both the timetable of services to be rendered and
the timing of services actually rendered. Based upon this
review, revisions may be made to the forecasted timetable or to
the extent of services performed, or both, in order to reflect
EPIXs most current estimate of the contract. Adjustments
are recorded in the period in which the revisions are estimable.
These adjustments could have a material effect on EPIXs
results of operations.
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Employee Stock Compensation |
EPIX has elected to follow Accounting Principles Board Opinion
No. 25, Accounting for Stock Issued to
Employees, or APB 25, and related interpretations
in accounting for EPIXs employee stock options under the
intrinsic value method, rather than the alternative fair value
accounting provided for under Statement of Financial Accounting
Standards No. 123(R), Share-Based
Payments An Amendment of FASB Statement No. 123
and 95, or SFAS 123R. Under APB 25, because
the exercise price is equal to the market price of the
underlying stock on the date of the grant, no compensation
expense is recognized.
EPIXs financial results could be materially adversely
affected by the required adoption of SFAS 123R, effective
January 1, 2006, to the extent of the additional
compensation expense that EPIX would have to recognize, which
could change significantly from period to period based on
several factors, including the number of stock options granted
and fluctuations in EPIXs stock price and/or interest
rates. See Note 2 to the Notes to Financial Statements.
Results of Operations
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Year ended December 31, 2005 and 2004 |
Revenues for the years ended December 31, 2005 and 2004
were $7.2 million and $12.3 million, respectively.
Revenues for 2005 consisted of $4.2 million for product
development revenue from Schering AG, $2.3 million for
royalty revenue related to the Bracco and Schering AG agreements
and $661,000 for license fee revenue related to the Schering AG,
Tyco/ Mallinckrodt strategic collaboration and Bracco
agreements. The decrease in total revenues of $5.1 million
for the year ended December 31, 2005 compared to the year
ended December 31, 2004 was attributed to lower product
development and license fee revenues, partly offset by higher
royalty revenue. The lower product development revenue accounted
for $3.4 million of the decrease between the two periods
and resulted from: (a) revenue adjustments related to the
overall increases in the costs and timeline to complete the
EP-2104R development program that were directly attributed to
amending EPIXs Phase II
proof-of-concept
clinical trial protocols for
EP-2104R to include
additional patient safety monitoring; (b) lower costs
incurred in 2005 compared to 2004 for the EP-2104R development
program resulting in lower recognition of revenue during 2005;
and (c) lower reimbursable costs from Schering AG on the
Vasovist program. The overall reduction in product development
revenue related to the Vasovist and
EP-2104R programs was
partly offset by slightly higher revenue under the research
collaboration agreement with Schering AG. The increase in
royalty revenue in 2005 was primarily attributed to the
adjustment recorded by EPIX at the end of 2004 to reflect
Braccos revised determination of sales and its royalty
overpayment assertion. Royalty revenue in 2005 included
royalties from sales by Bracco of MultiHance and Schering
AGs sales of Primovist. The license fee revenue in 2005
was lower than in 2004 primarily because of a non-repetitive
Bracco FDA milestone that was recognized in 2004 and, to a
lesser extent, changes made in 2005 to EPIXs estimate of
the approval date for Vasovist in the United States based on FDA
actions.
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Research and Development Expenses |
EPIXs research and development expenses arise from
EPIXs development activities for Vasovist and EP-2104R and
from EPIXs discovery research programs. Research and
development expenses for the year ended December 31, 2005
were $20.8 million compared to $21.9 million for the
same period in 2004. The decrease in research and development
expenses of $1.1 million during the year ended
December 31, 2005 resulted from lower spending for the
Vasovist and EP-2104R development programs, partly offset by
higher spending for EPIXs MRI and therapeutics research
programs.
The timeframe and costs involved in developing EPIXs
product candidates, including Vasovist and EP-2104R, and gaining
regulatory approval for and commercializing EPIXs product
candidates may vary greatly from current estimates for several
reasons, including the following:
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EPIX conducts EPIXs clinical trials in accordance with
specific protocols, which EPIX has filed with the FDA or other
relevant authorities. If the FDA requires EPIX to perform
additional trials, to perform additional procedures in
EPIXs trials or to increase patient numbers in those
trials, EPIX could incur significant additional costs and
additional time to complete EPIXs clinical trials,
assuming EPIX is able to reach agreement with the FDA on
protocols for any additional trials or procedures. |
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EPIX relies on third party clinical trial centers to find
suitable patients for EPIXs clinical trial program. If
these clinical trial centers do not find suitable patients in
the timeframe for which EPIX has planned, EPIX will not be able
to complete EPIXs clinical trials according to EPIXs
expected schedule. |
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EPIX relies on third party contract research organizations for a
variety of activities in EPIXs development program,
including conducting blinded reading activities, lab testing and
analysis of clinical samples, data collection, cleanup and
analysis and drafting study reports and regulatory submissions. |
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The length of time that the FDA or other regulatory authorities
take to review EPIXs regulatory submissions and the length
of time it takes EPIX to respond to the FDA or other regulatory
authorities questions can also vary widely. In January
2005, EPIX received an approvable letter from the FDA for
Vasovist in which the FDA requested additional clinical studies
to demonstrate efficacy prior to approval. In May 2005, EPIX
submitted EPIXs response to the approvable letter received
from the FDA in January 2005 and it was accepted by the FDA as a
complete response in June 2005. In November 2005, EPIX received
a second approvable letter from the FDA for Vasovist in which
the FDA again requested an additional clinical trial and a
re-read of images in certain of the previously completed
Phase III trials. The process of obtaining agreement with
the FDA for conducting necessary clinical trial studies is
subject to significant uncertainties in terms of timing, costs
and success. |
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EPIXs partner, Schering AG, is responsible for the
commercial launch and marketing of Vasovist in Europe, where
Vasovist has been approved for commercial sale, and in the
United States, where Vasovist is not approved for commercial
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Current plans for developing and commercializing Vasovist and
EP-2104R reflect EPIXs best estimate of the time involved
in the development program based on factors currently known to
us. The third parties described above have the ability to
greatly impact this timetable and EPIX may not have control over
changes they cause to EPIXs current estimates.
Under EPIXs EP-2104R agreement, Schering AG has made fixed
payments to EPIX totaling approximately $9.0 million over a
two year period, which was initially intended to cover most of
EPIXs costs of the feasibility program. The amount of
expenditure necessary to execute the feasibility program is
subject to numerous uncertainties, which may adversely affect
EPIXs cash outlay, net of Schering AGs reimbursement
to us. In July 2005, EPIX announced that EPIX would be amending
EPIXs Phase II
proof-of-concept
clinical trial protocols for EP-2104R to include additional
patient safety monitoring based
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on a review by the FDA of data from a
14-day, repeat dose
pre-clinical toxicology study. The additional patient monitoring
in the Phase II trials resulted in slower than expected
enrollment in this trial and extended the timeline and increased
the estimated costs for EP-2104R development. Based on the
latest review of the EP-2104R feasibility program, management
lowered its estimate of cost to complete the feasibility program
from $16.1 million to $15.2 million at
December 31, 2005. EPIX added clinical trial sites and took
other steps to improve enrollment in this trial and completed
this trial in the first quarter of 2006.
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General and Administrative Expenses |
General and administrative expenses, which consist primarily of
salaries, benefits, outside professional services and related
costs associated with EPIXs executive, finance and
accounting, business development, marketing, human resources,
legal and corporate communications activities, were
$10.2 million for the year ended December 31, 2005 as
compared to $10.5 million for the year ended
December 31, 2004. The decrease in spending of $251,000 by
EPIX resulted from lower marketing expenses related to Vasovist
that was partly offset by higher liability insurance premiums
and higher corporate administration, primarily attributed to
legal costs, combined with higher business development costs.
General and administrative expenses also include royalties
payable to Massachusetts General Hospital, or MGH, based on
sales by Bracco of MultiHance. Royalty expenses totaled $98,000
and $31,000 for the years ended December 31, 2005 and 2004,
respectively.
Restructuring costs for the year ended December 31, 2005
were $1.0 million as compared to $0 for the year ended
December 31, 2004. The restructuring costs related to
planned actions taken by management to control costs and improve
the focus of operations in order to reduce losses and conserve
cash. EPIX announced a planned reduction in its workforce by
approximately 50%, in response to the FDAs second approval
letter regarding Vasovist. The reductions, which were completed
in January 2006, affected both the research and development and
the general and administrative areas of EPIX. EPIX reported a
charge of approximately $1.0 million for severance and
related benefits as of December 31, 2005. Substantially all
payments related to the separation of employment were completed
in the first quarter of 2006.
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Interest Income and Interest Expense |
Interest income for the year ended December 31, 2005 was
$4.1 million as compared to $2.0 million for the year
ended December 31, 2004. The increase of $2.1 million
was primarily due to higher interest rates and higher average
levels of invested cash, cash equivalents and marketable
securities during 2005 as a result of receipt of the net
proceeds from the issuance of $100.0 million convertible
senior notes in June 2004. Interest expense for the years ended
December 31, 2005 and 2004 was $3.6 million and
$2.1 million, respectively. The increase in interest
expense of $1.5 million for the year ended
December 31, 2005 directly resulted from the issuance of
convertible senior notes in June 2004, partly offset by the
reduction in the outstanding balance of interest-bearing prepaid
royalties from Bracco and a reduction in interest expense
resulting from managements decision not to drawdown the
loan facility from Schering AG at the end of 2005. In January
2006, EPIX completed an agreement with Schering AG to terminate
the loan facility.
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Provision for Income Taxes |
The provision for income taxes, which represents Italian income
taxes related to the Bracco agreement, was $42,000 for the year
ended December 31, 2005 as compared to $100,000 for the
year ended December 31, 2004. Since the remaining balance
of prepaid royalties were offset at the end of the third quarter
of 2005, Italian income taxes needed to be withheld on Bracco
royalties for MultiHance sales paid to EPIX during the fourth
quarter of 2005. EPIX expects to have Italian income taxes
withheld on
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Bracco royalties for the remainder of the agreement, which will
end in the E.U. midway through 2006 and in early 2007 for the
United States.
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Years ended December 31, 2004 and 2003 |
Revenues for the years ended December 31, 2004 and 2003
were $12.3 million and $13.5 million, respectively.
Revenues for 2004 consisted of $7.6 million of product
development revenue from Schering AG, $4.0 million of
license fee and milestone revenue related to the Bracco
agreement and to the Schering AG and Tyco/ Mallinckrodt
strategic agreements, and $627,000 of royalty revenue related to
the Bracco agreement. The decrease in revenues of
$1.2 million for the year ended December 31, 2004
compared to the same period in 2003 resulted from reduced
product development activities of $1.9 million, primarily
from Vasovist and lower royalties of $1.8 million from
Bracco, partly offset by higher license fee revenue of
$2.5 million resulting from the milestone related to
Braccos announcement of the FDAs approval of
MultiHance in the United States. The lower royalties were
primarily attributed to EPIXs decision to recognize the
full $1.8 million amount reflected in Braccos
position taken in December 2004 that it had overstated
non-U.S. royalties
over the previous four year period from 2001 to 2004. EPIX has
challenged Braccos underpayment, Braccos right to
recalculate previous royalties under the license agreement and
the substance of Braccos position that royalties were
overstated.
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Research and Development Expenses |
Research and development expenses for the year ended
December 31, 2004 were $21.9 million as compared to
$28.0 million for the same period in 2003. The decrease of
$6.1 million was primarily attributable to decreased costs
related to the completion of the NDA submission for Vasovist and
the intellectual property agreement entered into with
Dr. Martin Prince in the fourth quarter of 2003, partly
offset by higher spending for EP-2104R and other research
programs.
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General and Administrative Expenses |
General and administrative expenses were $10.5 million for
the year ended December 31, 2004 as compared to
$6.6 million for the year ended December 31, 2003. The
increase of $3.9 million was primarily attributable to
higher spending both by EPIX and by Schering AG for Vasovist
marketing, higher business development expenses, higher legal
expenses related to patent and intellectual property filings,
increased compliance costs due to the internal control review
required by the Sarbanes-Oxley Act and to higher liability
insurance premiums. General and administrative expenses also
include royalties payable to MGH based on sales by Bracco of
MultiHance. Royalty expenses totaled $31,000 and $103,000 for
the years ended December 31, 2004 and 2003.
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Interest Income and Interest Expense |
Interest income for the year ended December 31, 2004 was
$2.0 million as compared to $664,000 for the year ended
December 31, 2003. The increase of approximately
$1.3 million was primarily due to higher average levels of
invested cash, cash equivalents and marketable securities during
the period related to net proceeds from the issuance of
$100.0 million convertible senior notes in June 2004.
Interest expense for the years ended December 31, 2004 and
2003 was $2.1 million and $295,000, respectively. The
increase in interest expense of $1.8 million during the
year ended December 31, 2004 resulted from the issuance of
convertible senior notes in June 2004 and the drawdown of the
entire $15.0 million loan facility made available to EPIX
by Schering AG as part of the joint MRI research collaboration
entered into in May 2003, partly offset by the reduction in the
balance of interest-bearing prepaid royalties from Bracco. The
entire principal balance of the loan facility, which was
$15.0 million as of December 31, 2004, plus accrued
interest, was repaid in January 2005, and the loan facility has
been terminated.
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Provision for Income Taxes |
The provision for income taxes, which represents Italian income
taxes related to the Bracco agreement, was $100,000 for the year
ended December 31, 2004 as compared to $80,000 for the year
ended December 31, 2003. Beginning in July 2003 and
continuing throughout 2004, a portion of royalty revenue earned
was offset against the prepaid FDA approval license fee, thereby
reducing both payments to EPIX and the requirement to withhold
foreign taxes.
Liquidity and Capital Resources
EPIXs principal sources of liquidity consist of cash, cash
equivalents and available-for-sale marketable securities of
$124.7 million at December 31, 2005 as compared to
$164.4 million at December 31, 2004. The decrease in
cash, cash equivalents and available-for-sale marketable
securities was primarily attributed to funding of ongoing
operations and to managements decision not to drawdown the
$15.0 million loan facility from Schering AG at the end of
2005.
EPIX used approximately $24.3 million of net cash to fund
operations for the year ended December 31, 2005, which
compares to $22.5 million for the same period in 2004. The
net use of cash to fund operations during the year ended
December 31, 2005 resulted from the net loss of
$24.3 million, combined with a reduction in deferred
revenue of $2.4 million, and was offset by decreases in
accounts receivable of $173,000 and prepaid expenses of
$238,000, an increase in accounts payable of $330,000 and to
non-cash expenses, primarily comprised of depreciation and
amortization of $1.7 million. The reduction in deferred
revenue resulted from the offset of prepaid royalties from
Bracco, plus the recognition of other license fee revenue
related to payments from Schering AG, Tyco/ Mallinckrodt and
Bracco, which are being amortized into revenue in accordance
with the requirements of SAB 104. The decrease in accounts
receivable was primarily attributed to lower pre-launch
marketing costs reimbursable by Schering AG. The decrease in
prepaid expenses resulted from the change in the timing of
insurance premium payments. The increase in accounts payable was
due to a number of larger clinical trial invoices that came in
late in the year related to the
EP-2104R development
program. For the year ended December 31, 2004, net cash
used for operating activities of $22.5 million was
primarily attributable to EPIXs net loss of
$20.4 million, combined with reduction in deferred revenue
of $3.7 million, a reduction in accrued expenses of
$1.3 million and a reduction in accounts payable of
$1.0 million, partly offset by an increase in contract
advances of $3.0 million. The reduction in deferred revenue
resulted from royalty revenues from sales by Bracco of
MultiHance, which were offset against advanced payments, plus
the recognition of other license fee revenue related to payments
from Schering AG, Tyco/ Mallinckrodt and Bracco, which are being
amortized into revenue in accordance with the requirements of
SAB 104. The decrease in accrued expenses was due to the
completion of pre-clinical development activities in 2004 and to
the issuance of common stock to Dr. Martin R. Prince in
January 2004 to offset an accrual in 2004 in connection with the
intellectual property agreement entered into in November of
2003. The decrease in accounts payable is due to lower year-end
spending levels compared to 2004. The increase in contract
advances primarily related to Schering AGs funding of both
EPIXs and Schering AGs Vasovist pre-launch
activities. Also during 2004, EPIX received a $2.5 million
milestone payment from Schering AG related to the acceptance of
the filing of the NDA with the FDA for Vasovist. Immediately
following this receipt, EPIX paid Tyco/ Mallinckrodt
$2.5 million in recognition of the same milestone. These
payments were offset in EPIXs Statements of Operations,
resulting in no impact on revenues, expenses or net loss.
EPIXs investing activities resulted in net cash provided
of $37.8 million for the year ended December 31, 2005
as compared to net cash used of $50.1 million for the same
period last year. During the year ended December 31, 2005,
EPIX sold or redeemed available-for-sale marketable securities
of $127.6 million, partly offset by the cash used to
purchase $88.6 million of available-for-sale marketable
securities that was primarily funded from the rollover of
securities within EPIXs portfolio. During the same period
in 2004, EPIX purchased $93.7 million of available-for-sale
marketable securities, which was partly funded from the funds
received from the convertible debt issuance and partly offset by
cash generated from the redemption of available-for-sale
marketable securities of $45.6 million. Other investing
activities included capital expenditures of $1.2 million
for the year ended December 31, 2005 as compared
146
to $2.1 million for the same period last year. The higher
capital expenditures in 2004 were primarily attributed to
leasehold improvements and to the acquisition of equipment,
including lab equipment, computer equipment and software,
related to the refurbishment of EPIXs laboratory space.
Cash used in financing activities was $14.4 million for the
year ended December 31, 2005 as compared to cash provided
of $109.3 million for the year ended December 31,
2004. The primary usage of cash during the year ended
December 31, 2005 was for the cumulative repayment of
$60.0 million on EPIXs loan facility with Schering
AG. Sources of financing during the same period came from the
cumulative drawdown of the loan facility of $45.0 million
with Schering AG and proceeds from stock option exercises and
EPIXs Employee Stock Purchase Plan of $578,000. There was
no drawdown of the loan facility from Schering AG at the end of
2005. In January 2006, EPIX and Schering AG agreed to terminate
the loan facility. During the year ended December 31, 2004,
EPIX received net proceeds of $96.4 million from the
issuance of convertible senior notes and another
$5.5 million from stock option exercises and proceeds from
EPIXs Employees Stock Purchase Plan. In addition, EPIX
cumulatively borrowed $52.5 million and repaid
$45.0 million during the year ended December 31, 2004
on EPIXs loan facility with Schering AG.
EPIX currently receives quarterly cash payments from Schering AG
for its share of development costs of Vasovist and for its share
of research costs on EPIXs joint MRI research
collaboration. EPIX also receives monthly interest income on
EPIXs cash, cash equivalents and available-for-sale
marketable securities. EPIX is also scheduled to receive
quarterly royalty payments from Bracco for a portion of the
royalty revenue actually earned from the sales of MultiHance.
With the expiration in 2006 of certain patents related to the
sublicense with Bracco, EPIX expects to receive lower royalty
payments from Bracco beginning in the second half of 2006. In
December 2004, Bracco asserted that it had overstated
non-U.S. royalties
to EPIX for the period 2001 to 2004 and that it would offset the
amount of the overstatement against its payment to us, including
those triggered by FDA approval of MultiHance in the United
States. Although EPIX still is disputing Braccos position,
EPIX recognized the impact of Braccos claimed
overstatement by reducing 2004 royalty revenues. Other potential
cash inflows include: a milestone payment of $1.3 million
from Schering AG, which is dependent on the FDAs approval
of Vasovist, and up to $22.0 million in additional
milestone payments from Schering AG as well as EPIXs share
of the profits earned on sales of Vasovist worldwide. Additional
future cash flows from EPIXs EP-2104R collaboration with
Schering AG of up to $15.0 million depend on the successful
completion of the EP-2104R feasibility program, on Schering
AGs decision to exercise its development option and on the
success of further development, regulatory and commercialization
work by Schering AG, none of which is assured at this time.
Additional future cash flows from EPIXs MRI research
collaboration with Schering AG depend on the success of the
research program and the success of further development,
regulatory and commercialization activities with respect to any
products generated. In October 2005, EPIX announced that an
amendment to the research collaboration agreement had been
entered into with Schering AG. This amendment narrowed the
definition of the field of EPIXs collaboration with
Schering AG. This research collaboration expires in May 2006,
and EPIX believes that it is unlikely that the parties will
extend the term of the collaboration. EPIX expects to discuss
the disposition of current research programs with Schering AG
prior to expiration of the collaboration and to continue to
advance at least some of these programs either unilaterally or
with another partner. Pursuant to the license agreement between
EPIX and Schering AG, EPIX is entitled to a worldwide royalty on
sales of certain Schering AG products covered by the agreement.
Known outflows, in addition to EPIXs ongoing research and
development and general and administrative expenses, include the
semi-annual royalties that EPIX owe to MGH on sales by Bracco of
MultiHance; a milestone payment of $2.5 million owed to
Tyco/ Mallinckrodt, which is dependent on the FDAs
approval of Vasovist; a share of profits due Tyco/ Mallinckrodt
on sales of Vasovist worldwide; a royalty to Daiichi on sales of
Vasovist in Japan and a royalty due MGH on EPIXs share of
the profits of Vasovist worldwide. With the expiration in 2006
of certain patents related to the license with MGH, EPIX expects
to reduce EPIXs royalty payments to MGH beginning in the
second half of 2006. As of
147
December 31, 2005, all remaining unearned prepaid royalties
that would be due to Bracco upon termination of EPIXs
license agreement have been offset against earned royalties.
EPIX expects that EPIXs cash, cash equivalents and
marketable securities on hand as of December 31, 2005 will
be sufficient to fund EPIXs operations for at least the
next several years. If, however, EPIX considers other
opportunities, changes its planned activities or is required to
pay all or a substantial portion of the milestone payment in
cash under the merger agreement it may require additional
funding before currently expected. If holders of EPIXs
convertible senior notes require redemption of the notes, EPIX
may be required to repay $100.0 million upon any
redemption. EPIXs future liquidity and capital
requirements will depend on numerous factors, including the
following: the progress and scope of clinical and pre-clinical
trials; the timing and costs of filing future regulatory
submissions; the timing and costs required to receive both U.S.
and foreign governmental approvals; the cost of filing,
prosecuting, defending and enforcing patent claims and other
intellectual property rights; the extent to which EPIXs
products, if any, gain market acceptance; the timing and costs
of product introductions; the extent of EPIXs ongoing and
new research and development programs; the costs of training
physicians to become proficient with the use of EPIXs
potential products; and, if necessary, once regulatory approvals
are received, the costs of developing marketing and distribution
capabilities. If EPIX completes the merger, Predix does not have
significant revenues and has significant product development
expenses which will accelerate EPIXs use of funds and its
need for additional funding.
Because of anticipated spending for the continued development of
Vasovist and EP-2104R and to support selective research
programs, EPIX does not expect positive cash flow from operating
activities for any future quarterly or annual period prior to
commercialization of Vasovist in the United States.
The following table represents payments due under contractual
obligations and commercial commitments as of December 31,
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
|
|
| |
|
|
|
|
Less Than | |
|
1-3 | |
|
3-5 | |
|
More Than | |
Contractual Obligations |
|
Total | |
|
1 Year | |
|
Years | |
|
Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Long-term debt obligations, including interest payments
|
|
$ |
116,375,000 |
|
|
$ |
3,000,000 |
|
|
$ |
6,000,000 |
|
|
$ |
6,000,000 |
|
|
$ |
101,375,000 |
|
Operating lease obligations
|
|
|
2,627,996 |
|
|
|
1,303,059 |
|
|
|
1,324,937 |
|
|
|
|
|
|
|
|
|
Purchase obligations
|
|
|
5,933,866 |
|
|
|
5,764,188 |
|
|
|
169,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
124,936,862 |
|
|
$ |
10,067,247 |
|
|
$ |
7,494,615 |
|
|
$ |
6,000,000 |
|
|
$ |
101,375,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPIX has incurred tax losses to date and therefore have not paid
significant federal or state income taxes since inception. As of
December 31, 2005, EPIX had federal net operating loss
carryforwards of approximately $180.4 million available to
offset future taxable income. These amounts expire at various
times through 2025. As a result of ownership changes resulting
from sales of equity securities, EPIXs ability to use the
net operating loss carryforwards is subject to limitations as
defined in Sections 382 and 383 of the Internal Revenue
Code of 1986, as amended, or the Code. EPIX currently estimates
that the annual limitation on EPIXs use of net operating
losses generated through May 31, 1996 to be approximately
$900,000. Pursuant to Sections 382 and 383 of the Code, the
change in ownership resulting from public equity offerings in
1997 and any other future ownership changes may further limit
utilization of losses and credits in any one year. EPIX also is
eligible for research and development tax credits that can be
carried forward to offset federal taxable income. The annual
limitation and the timing of attaining profitability may result
in the expiration of net operating loss and tax credit
carryforwards before utilization.
Certain Factors That May Affect Future Results of
Operations
This report contains certain forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act
of 1995. Such statements are based on managements current
expectations and are subject to a number of factors and
uncertainties, which could cause actual results to
148
differ materially from those described in the forward-looking
statements. EPIX cautions investors that there can be no
assurance that actual results or business conditions will not
differ materially from those projected or suggested in such
forward-looking statements as a result of various factors,
including, but not limited to, the following: the uncertainties
associated with pre-clinical studies and clinical trials;
EPIXs lack of product revenues; EPIXs history of
operating losses and accumulated deficit; EPIXs lack of
commercial manufacturing experience and commercial sales,
distribution and marketing capabilities; reliance on suppliers
of key materials necessary for production of EPIXs
products and technologies; the potential development by
competitors of competing products and technologies; EPIXs
dependence on existing and potential collaborative partners, and
the lack of assurance that EPIX will receive any funding under
such relationships to develop and maintain strategic alliances;
the lack of assurance regarding patent and other protection for
EPIXs proprietary technology; governmental regulation of
EPIXs activities, facilities, products and personnel; the
potential delays or failure in receiving necessary approvals;
the dependence on key personnel; uncertainties as to the extent
of reimbursement for the costs of EPIXs potential products
and related treatments by government and private health insurers
and other organizations; the potential adverse impact of
government-directed health care reform; the risk of product
liability claims; and economic conditions, both generally and
those specifically related to the biotechnology industry. As a
result, EPIXs future development efforts involve a high
degree of risk. For further information, refer to the more
specific risks and uncertainties discussed throughout this joint
proxy statement/ prospectus.
Quantitative and Qualitative Disclosures About Market Risk
The objective of EPIXs investment activities is to
preserve principal, while at the same time maximizing yields
without significantly increasing risk. To achieve this
objective, in accordance with this investment policy, EPIX
invests its cash in a variety of financial instruments,
principally restricted to government-sponsored enterprises,
high-grade bank obligations, high-grade corporate bonds and
certain money market funds. These investments are denominated in
U.S. dollars.
Investments in both fixed rate and floating rate interest
earning instruments carry a degree of interest rate risk. Fixed
rate securities may have their fair market value adversely
impacted due to a rise in interest rates, while floating rate
securities may produce less income than expected if interest
rates fall. Due in part to these factors, EPIXs future
investment income may fall short of expectations due to changes
in interest rates or EPIX may suffer losses in principal if
forced to sell securities that have seen a decline in market
value due to changes in interest rates. A hypothetical 10%
increase or decrease in interest rates would result in a
decrease in the fair market value of EPIXs total portfolio
of approximately $71,000, and an increase of approximately
$71,000, respectively, at December 31, 2005.
Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure
None.
149
EPIX PRINCIPAL STOCKHOLDERS
The following table sets forth certain information with respect
to the beneficial ownership of EPIX common stock as of
March 31, 2006 for (a) the executive officers named in
the Summary Compensation Table elsewhere in this joint proxy
statement/ prospectus, (b) each of EPIXs directors
and director nominees, (c) all of EPIXs current
directors and executive officers as a group and (d) each
stockholder known by EPIX to own beneficially more than 5% of
EPIX common stock. Beneficial ownership is determined in
accordance with the rules of the Securities and Exchange
Commission and includes voting or investment power with respect
to the securities. EPIX deems shares of EPIX common stock that
may be acquired by an individual or group within 60 days of
March 31, 2006 pursuant to the exercise of options or
warrants to be outstanding for the purpose of computing the
percentage ownership of such individual or group, but are not
deemed to be outstanding for the purpose of computing the
percentage ownership of any other person shown in the table.
Except as indicated in footnotes to this table, EPIX believes
that the stockholders named in this table have sole voting and
investment power with respect to all shares of EPIX common stock
shown to be beneficially owned by them based on information
provided to EPIX by these stockholders. Percentage of ownership
is based on 23,284,810 shares of EPIX common stock
outstanding on March 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
Shares Beneficially | |
|
|
Owned | |
|
|
| |
Name and Address ** |
|
Number | |
|
Percent | |
|
|
| |
|
| |
Prescott Group Capital Management, L.L.C.(1)
|
|
|
1,712,334 |
|
|
|
7.35 |
% |
|
1924 South Utica, Suite 1120 |
|
|
|
|
|
|
|
|
|
Tulsa, Oklahoma 74104-6529 |
|
|
|
|
|
|
|
|
Michael J. Astrue
|
|
|
|
|
|
|
* |
|
Andrew C.G. Uprichard, M.D.(2)
|
|
|
45,500 |
|
|
|
* |
|
Robert Pelletier, CPA(3)
|
|
|
22,131 |
|
|
|
* |
|
Michael D. Webb(4)
|
|
|
32,666 |
|
|
|
* |
|
Peyton J. Marshall, Ph.D.(5)
|
|
|
64,000 |
|
|
|
* |
|
Christopher F.O. Gabrieli(6)
|
|
|
217,450 |
|
|
|
* |
|
Gregory D. Phelps(7)
|
|
|
8,334 |
|
|
|
* |
|
Mark Leuchtenberger(8)
|
|
|
8,334 |
|
|
|
* |
|
Peter Wirth, Esq.(9)
|
|
|
55,000 |
|
|
|
* |
|
Michael Gilman, Ph.D.
|
|
|
|
|
|
|
* |
|
All current directors and executive officers as a group (7
persons)(10)
|
|
|
356,749 |
|
|
|
1.53 |
% |
|
|
|
|
* |
Represents beneficial ownership of less than 1% of the
outstanding shares of EPIX common stock. |
|
|
|
|
** |
Addresses are given for beneficial owners of more than 5% of
outstanding EPIX common stock only. |
|
|
|
|
(1) |
Includes (a) 1,630,334 shares of EPIX common stock
held by the Prescott Group Aggressive Small Cap Master Fund,
G.P., of which Prescott Group Aggressive Small Cap, L.P. and
Prescott Group Aggressive Small Cap II, L.P. are general
partners, and (b) 82,000 shares of EPIX common stock
held by Phil Frohlich. Prescott Group Capital Management, L.L.C.
serves as the general partner of Prescott Group Aggressive Small
Cap, L.P. and Prescott Group Aggressive Small Cap II, L.P.
and may direct Prescott Group Aggressive Small Cap, L.P. and
Prescott Group Aggressive Small Cap II, L.P., the general
partners of Prescott Group Aggressive Small Cap Master Fund,
G.P., in connection with the voting and disposition of the
1,630,334 shares of EPIX common stock held by Prescott
Group Aggressive Small Cap Master Fund, G.P. As principal of
Prescott Group Capital Management, L.L.C., Mr. Frohlich may
direct the vote and disposition of the 1,630,334 shares of
EPIX common stock held by Prescott Group Aggressive Small Cap
Master Fund, G.P. and the 82,000 shares of EPIX common
stock held by himself, individually. This information is based
solely on a Schedule 13G filed by Prescott Group Capital
Management, L.L.C. with the Securities and Exchange Commission
on January 30, 2006, which reported ownership as of
October 10, 2005. |
150
|
|
|
|
(2) |
Represents shares of EPIX common stock subject to options
exercisable by Dr. Uprichard within the
60-day period following
March 31, 2006. |
|
|
(3) |
Consists of 1,561 shares of EPIX common stock owned of
record by and 20,570 shares of EPIX common stock subject to
options exercisable by Mr. Pelletier within the
60-day period following
March 31, 2006. |
|
|
(4) |
Consists of 14,166 shares of EPIX common stock owned of
record by Mr. Webb and 18,500 shares of EPIX common
stock held by Mr. Webbs wife as to which
Mr. Webb disclaims beneficial ownership. Effective
September 14, 2005, Mr. Webb resigned as Chief
Executive Officer and member of the EPIX board of directors, but
continued to serve as a consultant to EPIX through
December 31, 2005. |
|
|
(5) |
Represents 64,000 shares of EPIX common stock owned of
record by Mr. Marshall. Effective July 1, 2005,
Mr. Marshall resigned as Senior Vice President, Finance and
Administration and Chief Financial Officer of EPIX. |
|
|
(6) |
Consists of 152,450 shares of EPIX common stock owned of
record by Mr. Gabrieli and 65,000 shares of EPIX
common stock subject to options exercisable by Mr. Gabrieli
within the 60-day
period following March 31, 2006. |
|
|
(7) |
Represents shares of EPIX common stock subject to options
exercisable by Mr. Phelps within the
60-day period following
March 31, 2006. |
|
|
(8) |
Represents shares of EPIX common stock subject to options
exercisable by Mr. Leuchtenberger within the
60-day period following
March 31, 2006. |
|
|
(9) |
Represents shares of EPIX common stock subject to options
exercisable by Mr. Wirth within the
60-day period following
March 31, 2006. Mr. Wirth has notified EPIX that he is
not standing for reelection to the EPIX board of directors at
the EPIX 2006 annual stockholders meeting. |
|
|
(10) |
Includes 202,738 shares of EPIX common stock subject to
options exercisable within the
60-day period following
March 31, 2006. See also footnotes (2), (3) and
(6) through (9) above. |
151
PREDIXS BUSINESS
Overview
Predix is a pharmaceutical company focused on the discovery and
development of novel, highly selective, small-molecule drugs
that target G-Protein Coupled Receptors, or GPCRs, and ion
channels. Predix believes that these classes of proteins provide
a rich source of drug targets that it can exploit using its
proprietary drug discovery technology. Combined with a focused
drug development and regulatory strategy, Predixs
proprietary drug discovery technology and approach has enabled
it to discover, develop, and advance three drug candidates into
clinical trials in the last three-and-a-half years. Predix
believes that its competitive advantage in the pharmaceutical
industry stems from its integration of computational
technologies into all of its drug discovery programs.
Predixs lead clinical-stage drug candidate, PRX-00023, is
currently in the first of at least two pivotal Phase III
trials for the treatment of generalized anxiety disorder, or
GAD. At least one additional Phase III trial will be
required to support efficacy claims. Enrollment of patients for
this first trial began in August 2005 and initial results are
expected in the second half of 2006. Predix has two other
clinical-stage drug candidates, PRX-03140 for the treatment of
Alzheimers disease and PRX-08066 for the treatment of two
types of pulmonary hypertension, or PH: pulmonary arterial
hypertension, or PAH, and PH associated with chronic obstructive
pulmonary disease, or COPD. PRX-03140 has completed three
Phase I clinical trials, including a Phase Ib clinical
trial in Alzheimers patients. PRX-08066 has completed
three Phase I clinical trials, including a Phase Ib
clinical trial in conditioned athletes exposed to low oxygen
conditions, a model for PH.
GPCRs and ion channels are classes of proteins embedded in the
surface membrane of all cells and are responsible for mediating
much of the biological signaling at the cellular level. Of the
top 50 selling drugs worldwide, as identified by IMS Health,
Predix believes that nearly 40% interact with GPCRs or ion
channels as their target proteins. Despite the commercial
success of these drugs, many have undesired side effects due in
part to these drugs binding not only to their target protein but
also to other off-target proteins. Because very few
high-resolution molecular structures are available for GPCR or
ion channel proteins, drug discovery for these targets is
costly, inefficient, and in many cases does not lead to the
desired, selective drug candidate. A greater understanding of
these protein structures would allow compounds to be chemically
altered to achieve specificity for the target and lack affinity
for other receptors that are believed to be associated with side
effects.
Predix believes that its proprietary drug discovery technology
and approach addresses many of the inefficiencies associated
with traditional GPCR and ion channel-targeted drug discovery.
Predixs approach integrates computational, or in
silico, technology with its medicinal chemistry
capabilities, allowing it to rapidly identify and optimize
highly selective drug candidates. Predix focuses on GPCR and ion
channel drug targets whose role in disease has already been
demonstrated in clinical trials or pre-clinical studies. In each
of its three clinical-stage programs, Predix used its technology
and approach to optimize a lead compound into a drug candidate
in less than ten months, synthesizing fewer than 80 compounds
per program. Predix moved each of these drug candidates into
clinical trials in less than 18 months from lead
identification. Predix believes that its drug discovery
technology and approach enables it to efficiently and
cost-effectively discover and develop GPCR and ion
channel-targeted drug candidates.
Since September 2002, Predix has discovered, optimized and
advanced to clinical trials three drug candidates that are
intended to address significant unmet medical needs with large
global market opportunities. Predixs clinical-stage drug
candidates are:
PRX-00023. Predix is developing PRX-00023 for the
treatment of anxiety and depression.
PRX-00023 is a novel,
long acting, highly selective, small-molecule stimulator, or
agonist, of a specific GPCR known as
5-HT1A. Predixs
initial therapeutic focus for PRX-00023 has been on the
treatment of GAD. Enrollment of patients began in August 2005
for the first of at least two pivotal Phase III trials with
PRX-00023 for the treatment of GAD. Predix originally submitted
the protocol for this trial to the FDA in June 2005 and
subsequently submitted the statistical analysis plan for this
trial to the FDA in
152
August 2005. The protocol design and endpoints were deemed
acceptable by the FDA in August 2005 and the statistical
analysis plan was deemed acceptable by the FDA in November 2005.
The ongoing Phase III trial follows a standard design for
testing drug candidates for GAD: patients with
moderate-to-severe GAD
are randomized to either placebo or PRX-00023 for eight weeks.
The primary endpoint is the change in the severity of the GAD
(measured by an FDA-accepted scale) at week eight in the
PRX-00023 arm versus the placebo arm. Because the clinical
development path of other 5-HT1A agonists in psychiatric
disorders was well-established, and the mechanism of action of
PRX-00023 had been validated in the clinic with other agents,
Predix moved rapidly into this first pivotal Phase III
clinical trial after it had completed an open-label
Phase IIa trial in GAD patients in July 2005. PRX-00023 was
well tolerated at the two doses given orally once per day over
this four week Phase II trial, with an acceptable adverse
event profile. There were no serious adverse events and no
patient discontinuations due to drug-related adverse events. In
addition, results indicated that PRX-00023 given for four weeks
significantly lowered measures of anxiety from baseline. These
results are based on a small number of patients in an
early-stage clinical trial and are not necessarily predictive of
results in later-stage clinical trials with larger and more
diverse patient populations. Predix intends to initiate clinical
development of
PRX-00023 for the
treatment of depression in the future, and expects to be able to
rely on the clinical trials completed to date for
PRX-00023 and begin
clinical development for a depression indication with
Phase II clinical trials. To date, there have been no
serious adverse events associated with treatment in more than
200 subjects who have received PRX-00023. Predix currently
intends to seek a collaboration to develop
PRX-00023 for
depression, but may initiate such Phase II clinical trials
in depression independently if circumstances allow. If Predix
does enter into a collaboration with respect to PRX-00023, it is
possible that any such collaboration will involve both the GAD
and depression indications.
PRX-03140. Predix is developing PRX-03140 for the
treatment of Alzheimers disease. PRX-03140 is a novel,
highly selective, small-molecule agonist of a specific GPCR
known as 5-HT4. Predix completed a Phase Ib clinical trial
in Alzheimers disease patients with PRX-03140 in September
2005. PRX-03140 was well tolerated in this trial and also in two
additional Phase I clinical trials in healthy adult and
elderly volunteers. In the
14-day Phase Ib
clinical trial in patients with
mild-to-moderate
Alzheimers disease, treatment with PRX-03140 resulted in
changes in brain wave activity in these patients that are
consistent with those seen in clinical trials with currently
approved drugs for Alzheimers disease. In the Phase I
clinical trials, PRX-03140 caused an expected, dose-dependent,
transient increase within normal levels of a hormone known to be
linked to 5-HT4 stimulation, consistent with the effects of
other 5-HT4 agonists. In several pre-clinical animal models,
PRX-03140 also enhanced cognition and exhibited trends towards
reduced levels of beta amyloid, or Ab, and increased levels of
the non-amyloidogenic alpha-secretase form of soluble amyloid
precursor protein, or sAPPa, proteins thought to be associated
with Alzheimers disease progression. In addition, in a
pre-clinical animal model of cognition, PRX-03140 demonstrated
synergistic activity when combined with an acetylcholinesterase
inhibitor. These results are based on pre-clinical animal
studies and a small number of patients in Phase I clinical
trials and are not necessarily predictive of results in
later-stage clinical trials with larger and more diverse patient
populations. Predix expects to initiate a Phase IIa trial
of PRX-03140 alone or in combination with an
acetylcholinesterase inhibitor in patients with Alzheimers
disease in the second half of 2006.
PRX-08066. Predix is developing PRX-08066 for the
treatment of PAH and PH associated with COPD. PAH is a serious,
often fatal cardiovascular disease characterized by elevation of
pulmonary blood pressure and progressive thickening and
narrowing of the blood vessels of the lungs, often leading to
heart failure. PRX-08066 is a novel, highly selective,
small-molecule inhibitor, or antagonist, of a specific GPCR
known as 5-HT2B. Predix has completed three Phase I
clinical trials of PRX-08066 in healthy volunteers, including a
Phase Ib clinical trial in athletes conditioned to exercise
at high altitudes with PH that has been induced by a reduction
in the level of inhaled oxygen. Preliminary results from the
Phase Ib trial indicate that PRX-08066 caused a
statistically significant reduction in the increase in systolic
pulmonary blood pressure observed during exercise in volunteers
breathing low oxygen, compared to placebo. In the two earlier
Phase I trials as well as the Phase Ib trial,
PRX-08066 was well-tolerated, with data supporting once or twice
daily oral dosing. Predix expects to initiate a Phase IIa
trial of PRX-08066 in patients with PH associated with COPD in
the second half of 2006.
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Predix also has ongoing GPCR and ion channel programs in
discovery, lead optimization and pre-clinical stages for the
treatment of obesity, cognitive impairment (associated with
Alzheimers disease or schizophrenia), cardiac arrhythmia,
cancer, inflammatory diseases, pain and cystic fibrosis.
Predixs most advanced drug candidate at the pre-clinical
stage is:
PRX-07034. Predix is developing PRX-07034 for the
treatment of obesity as well as cognitive impairment (associated
with Alzheimers disease or schizophrenia). PRX-07034 is a
novel, highly selective, small-molecule antagonist of a specific
GPCR known as 5-HT6. In pre-clinical animal models of obesity,
this drug candidate has demonstrated positive effects on the
reduction of both food intake and body weight. It has also
exhibited cognitive-enhancing properties in pre-clinical animal
models of memory impairment. PRX-07034 is currently in
toxicology studies to enable the submission of an IND to the FDA
in 2006.
Predix currently retains worldwide commercial rights to all of
its current clinical and pre-clinical drug candidates.
Predixs strategy is to establish strategic collaborations
with leading pharmaceutical and biotechnology companies to
further develop and commercialize certain of its drug candidates.
GPCRs and Ion Channels as Drug Targets
Of the top 50 selling drugs worldwide, as identified by IMS
Health, Predix believes that nearly 40% interact with GPCRs or
ion channels as their target proteins. These classes of drugs
include Zyprexa for the treatment of schizophrenia, Plavix for
the reduction of thromboembolic events (e.g., heart attack,
stroke) and Norvasc for the treatment of hypertension. Most
major therapeutic areas are served to some degree by drugs that
target these proteins, making GPCRs and ion channels attractive
targets for drug discovery.
GPCRs convert signals received from the outside of the cell into
biological processes inside the cell. A variety of well-known
biological molecules, including neurotransmitters and hormones,
can bind to GPCRs and trigger cellular processes involved in
health and disease. The following figure shows the structure of
a typical GPCR, highlighting its seven membrane-spanning (i.e.,
transmembrane) regions embedded in, and their orientation
within, the cell membrane. These transmembrane regions are known
to be important for GPCR-targeted drug binding, and Predix
believes that most GPCR-based drugs bind primarily in a cleft
where the transmembrane regions face towards the outside of the
cell.
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Ion channels are transmembrane proteins that form pores in the
cell membrane through which ions can pass. Ion flow through ion
channels can trigger a number of biological processes, including
electrical conduction in nerves and the heart, modulation of
cell-to-cell
communication and regulation of fluid balance. The following
figure shows the structure of a typical ion channel,
highlighting how the protein forms a pore in the cell membrane
through which ions pass.
Complexities of Traditional GPCR and Ion Channel Drug
Discovery
Drug discovery for GPCRs and ion channels has historically been
a long and costly process, due to insufficient structural
information for these targets which, if available, could guide
rational drug discovery and optimization. Lacking reliable
understanding of the three-dimensional, or 3D, structures of
these membrane proteins, scientists have used a variety of
experimental methods to discover GPCR and ion channel-targeted
drugs. The most common approach for GPCR drug discovery has been
high-throughput screening using genetically engineered cells
that show a fluorescent marker when GPCR pathways are activated.
This technique allows scientists to indirectly assess the
activity of hundreds of thousands of compounds in hopes of
identifying those that have affinity for a GPCR target.
Screening compounds for their effects on ion channels primarily
involves laborious measurements of the change in electric
current passing through the channels.
While these strategies have yielded some success, they are both
time-intensive and costly, and are poorly suited for the lead
optimization stage in drug discovery, where promising compounds,
or leads, are chemically manipulated in an attempt to improve
their drug-like properties (e.g., increasing absorption,
increasing half-life) while maintaining or improving affinity
for the target protein. The number of changes that are made to a
lead compound during optimization is typically substantial.
However, because very few structures of GPCRs or ion channels
are available, medicinal chemists have difficulties making
rational, structure-guided modifications to lead compounds and,
therefore, hundreds to thousands of compounds derived from the
lead compound typically are synthesized and tested during lead
optimization. Nevertheless, many of the currently available
FDA-approved GPCR or ion channel-targeted drugs bind to
off-target membrane proteins, which Predix believes may
contribute to their adverse side effect profiles.
Over the last two decades, experimental techniques to determine
protein structure, such as X-ray crystallography and nuclear
magnetic resonance, or NMR, have evolved and are commonly used
for structure-based drug discovery. Crystallography requires the
expression, purification and crystallization of the target
protein, and then uses analysis of diffracted X-rays to
determine its structure. While crystallization works well in an
aqueous (i.e., water-based) environment, it has not been
effectively optimized for the hydrophobic (i.e.,
water-repelling) environment of the cell membrane, where GPCRs
and ion channels are situated. NMR has the advantage of
measuring proteins in their native or functional state dissolved
in solution without the need for crystallization. However,
because GPCRs and ion channels are membrane-embedded, they can
not be dissolved into solution in their native state, preventing
NMR from being used to determine their functional structures.
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To supplement these experimental approaches, a method known as
homology modeling is often used to determine protein structure
in silico based on similarity to known protein
structures. However, this method is limited for GPCR and ion
channel proteins because few structures of these membrane-bound
targets have actually been determined. The one GPCR structure
that has been determined experimentally is a receptor for light
in the eye that does not use a biological molecule as its
activator. This structure therefore has little relevance to the
druggable GPCRs in humans.
More advanced methods of in silico modeling have also
been developed to create 3D representations of GPCRs and ion
channels. These models are built based on the experimental
knowledge from known drugs or ligands with specific amino acids
of the protein. For example, the basic portions of a drug will
interact with an acidic amino acid. Amino acids from the protein
are then oriented in space to mimic each of these interactions,
thus creating 3D models of binding and/or non-binding
interactions. Once created, these models are used to
dock potential drug candidates and prioritize the
synthesis and testing of compounds.
Predixs GPCR and Ion Channel Drug Discovery Technology
and Approach
Predix believes that its proprietary drug discovery technology
and approach, based on structure of the target protein and other
off-target proteins, can address many of the challenges that
have hindered GPCR and ion channel drug discovery. Using its
proprietary algorithms, Predix models the 3D structure of most
GPCRs from its primary amino acid sequence. Predix utilizes
known experimental data about the target and can incorporate
known drug structures into an in silico representation of
the 3D structure. Predixs technology enables it to explore
the possible structural geometries of most types of GPCR and ion
channel target proteins, taking into account specific
interactions between the protein and the membrane, as well as
specific interactions within the protein itself.
Predix uses these structures of the target GPCR or ion channel
together with other off-target structures and predictive
algorithms to discover and optimize highly selective drugs with
anticipated favorable side effect profiles. By implementing its
proprietary modeling and optimization technology along with
commercially available predictive models, Predix believes that
it can:
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incorporate greater selectivity into its drug candidates by
examining the interaction of suggested compounds with its
structures in silico, and eliminating those that may have
affinity for other proteins, which Predix believes will result
in drug candidates with favorable side effect profiles; |
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identify some potential safety, pharmacokinetics (i.e., the
determination of how much of a drug is absorbed, distributed,
metabolized and eliminated by the body) and toxicology issues
through in silico predictions prior to Predixs
medicinal chemists synthesizing and testing actual
compounds; and |
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synthesize approximately 10-30 fold fewer compounds than in
traditional GPCR or ion channel lead optimization programs by
adopting structure-based (i.e., rational) lead optimization
strategies and evaluating compounds in silico prior to
the synthesis of actual compounds, effectively reducing the
cycle time for the historically longest phase of drug discovery. |
Predix believes that its ability to achieve success in drug
discovery and optimization was first demonstrated in its anxiety
and depression program, targeting the GPCR known as 5-HT1A.
Predixs initial lead compound identified from in silico
screening had good affinity for 5-HT1A but was problematic
due to its high affinity for the off-target GPCRs named the
alpha-adrenergic receptors type 1 and 2, which are believed
to be associated with hypotension and lightheadedness. During
the first cycle of lead optimization, Predix determined the
structure of these off-target GPCRs, studied the interaction of
its lead compound with these structures, and then modified its
compound to reduce affinity for the off-target GPCRs while
maintaining affinity for the target. Predix accomplished this
goal within 15 compounds synthesized and in less than two months.
The next challenge Predix faced in lead optimization was
reducing affinity for a specific potassium ion channel protein
named hERG that has been linked to drug-induced cardiac
arrhythmia. In the second
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round of lead optimization, starting from the
15th molecule,
Predix created an in silico structure of the hERG ion
channel and modified its compound to reduce affinity for this
ion channel. Using its proprietary technology and approach,
Predix was able to maintain a good drug-like profile and resolve
the hERG issue, and Predix nominated its
23rd synthesized
compound, PRX-00023, as its drug candidate. PRX-00023 is now
Predixs lead clinical-stage drug candidate, currently in
the first of at least two pivotal Phase III trials for the
treatment of GAD.
Although Predixs drug discovery capabilities and approach
have not been applied to all types of GPCRs or ion channels that
are targeted for therapeutics, Predix believes that its
technology and approach to drug discovery is applicable to most
types of GPCRs and ion channels.
Predixs Strategy
Predix intends to become a leader in the discovery, development
and commercialization of novel small-molecule drugs that target
GPCRs and ion channels to address disease areas with significant
unmet medical need and commercial potential. Key elements of its
strategy are as follows:
Maximize commercial and shareholder value of Predixs
drug candidates. Predix has retained worldwide commercial
rights to all of its current clinical and pre-clinical drug
candidates. Predix currently intends to retain marketing and
sales or co-promotion rights for drug candidates that receive
market approval for indications in which it believes it is
possible to access the market through a specialized sales force.
Predix expects to establish strategic collaborations with
leading pharmaceutical and biotechnology companies to further
develop and commercialize certain of its drug candidates,
particularly for indications in which large sales forces are
required to access the market, as well as with respect to
markets outside the United States.
Capitalize on the commercial potential of Predixs lead
drug candidate, PRX-00023. Predix intends to focus on the
clinical development of PRX-00023 for the treatment of anxiety
initially and subsequently depression, both of which are disease
indications with a large commercial opportunity. Predix is
currently focusing its development efforts on the treatment of
GAD, with the first of at least two pivotal Phase III
clinical trials currently ongoing for PRX-00023 in this
indication. Initial results are expected in the second half of
2006. Predix will need additional funding to further develop and
commercialize PRX-00023 for the treatment of GAD, and may seek
to establish a collaboration with respect to this indication.
Predix expects to be able to rely on the clinical trials
completed to date for PRX-00023 and begin clinical development
for a depression indication with Phase II clinical trials.
Predix currently intends to seek a collaboration to develop
PRX-00023 for depression, but may initiate such Phase II
clinical trials in depression independently if circumstances
allow. If Predix does enter into a collaboration with respect to
PRX-00023, it is possible that any such collaboration will
involve both the GAD and depression indications.
Continue to advance Predixs additional clinical-stage
programs. Predix plans to continue to develop PRX-03140 for
the treatment of Alzheimers disease and PRX-08066 for the
treatment of PH. Predix completed a Phase Ib clinical trial
with PRX-03140 in Alzheimers disease patients in September
2005 and expects to initiate a Phase IIa clinical trial in
this patient population in the second half of 2006. Predix also
completed a Phase Ib clinical trial with PRX-08066 in March
2006, and expects to initiate a Phase IIa clinical trial of
PRX-08066 in COPD patients with PH in the second half of 2006.
Advance and continue to expand Predixs pipeline of
novel drug candidates to address unmet and/or underserved
medical needs. To minimize the risks inherent in drug
discovery and development, Predix intends to continue to focus
its efforts on discovering drug candidates for GPCR and ion
channel drug targets whose role in disease has already been
demonstrated in clinical trials or pre-clinical studies. Predix
believes that the breadth of its capabilities in GPCR and ion
channel drug discovery will enable it to continue expanding its
pipeline of novel, small-molecule drug candidates.
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Predixs Drug Development Programs
Through its GPCR and ion channel drug discovery expertise,
Predix has created a pipeline of drug candidates designed to
address diseases with significant unmet medical needs and
commercial potential across a range of therapeutic areas. The
following chart summarizes the status of Predixs product
pipeline, including its three clinical-stage drug candidates and
one drug candidate, PRX-07034, that Predix believes will be its
next clinical drug candidate:
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Clinical development of PRX-00023 for a depression indication
has not been initiated. Predix expects to be able to rely on the
clinical trials completed to date for PRX-00023 to begin
clinical development for a depression indication with
Phase II clinical trials. Predix currently intends to seek
a collaboration to develop PRX-00023 for depression, but may
initiate such clinical trials in depression independently if
circumstances allow. |
PRX-00023 for Anxiety and Depression
PRX-00023 is a novel, highly selective, small-molecule 5-HT1A
agonist that Predix is developing for the treatment of anxiety
and depression. The initial therapeutic focus for PRX-00023 is
on the treatment of GAD, and PRX-00023 is currently in the first
of at least two pivotal Phase III trials for the treatment
of this disorder. As required by the FDA guidelines for the
treatment of chronic disorders, at least two pivotal
Phase III trials will be required for the full efficacy
claim. Enrollment of patients for the first pivotal
Phase III trial began in August 2005, and initial results
are expected in the second half of 2006. Because the clinical
development path of other 5-HT1A agonists in psychiatric
disorders was well-established, and the mechanism of action of
PRX-00023 had been
validated in the clinic with other agents, following
consultation with the FDA Predix moved rapidly into this first
pivotal Phase III clinical trial after it had completed a
Phase IIa open-label trial in GAD patients in July 2005.
Three Phase I clinical trials for PRX-00023 in healthy
volunteers have also been completed. To date, there have been no
serious adverse events associated with treatment in more than
200 subjects who have received PRX-00023.
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Disease and Market Overview |
Anxiety and depression are the most prevalent mental illnesses
in the United States. Generalized anxiety disorder, or GAD, is
characterized by excessive and unrealistic anxiety about
everyday events and
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can be accompanied by restlessness, irritability and difficulty
concentrating. As a result of the excessive, uncontrollable
worry about common daily events, GAD can significantly impair
ones ability to function. According to the
U.S. National Institute of Mental Health, an estimated four
million adult Americans suffer from GAD. In 2003, approximately
$3 billion was spent on drug therapy worldwide to treat
anxiety disorders, according to Espicom. Depression covers a
variety of symptoms, including extreme sadness, sluggishness and
sleep and appetite disturbance. Depressive disorders affect
nearly 19 million adult Americans, according to the
U.S. National Institute of Mental Health. In 2004, an
estimated $15.9 billion was spent on drug therapy worldwide
to treat depression, according to Espicom.
Anxiety and depression are generally linked to abnormal
regulation of neurotransmitters in the brain, including
serotonin (5-HT), glutamate, noradrenaline and gamma-amino
butyric acid, or GABA. Neurotransmitters are chemicals in the
brain that either excite or inhibit neural function. GAD and
depression are often present together, and most patients are
treated with the same drugs. The most commonly used therapies
for anxiety and depression are selective serotonin reuptake
inhibitors, or SSRIs, and the more recently developed serotonin
noradrenaline reuptake inhibitors, or SNRIs. SSRIs selectively
block the reuptake of
5-HT from the synapse
of brain neurons, thereby increasing brain 5-HT concentrations.
SNRIs inhibit the reuptake of noradrenaline as well as 5-HT.
These drugs are thought to exert their effects by increasing
neurotransmitter availability and transmission.
A recent study showed that the increased 5-HT availability with
SSRI treatment results in beneficial mood and behavior effects
mainly through stimulation of 5-HT1A, one of the 14 known 5-HT
GPCR subtypes. However, because SSRIs and SNRIs increase 5-HT
levels in the brain, they can potentially stimulate the other
thirteen 5-HT GPCR subtypes, some of which are believed to lead
to the adverse side effects associated with these drugs,
including sexual dysfunction, weight changes and sleep disorders.
Benzodiazepines, such as Valium, are a chemical class of drugs
that are often prescribed for the short-term relief of GAD.
However, these sedating agents are controlled substances because
of their addictive properties, and can be lethal when used in
combination with alcohol.
Buspirone is an azapirone 5-HT1A agonist approved by the FDA for
the treatment of GAD, and it has been available in the United
States since 1986 as BuSpar, marketed by Bristol-Myers Squibb,
and generic equivalents. While buspirone does not have the
sexual dysfunction side effects common with SSRIs, or the
addictive and sedative properties of benzodiazepines, this drug
must be taken three times a day, requires approximately three
weeks of dose adjustment (known as titration) to reach
therapeutic levels, and may cause lightheadedness and nausea,
which are believed to be due to its affinity for off-target
GPCRs.
Several other 5-HT1A agonists have shown efficacy in clinical
trials in depression. However, most of these drugs belong to a
chemical class of drugs called azapirones, and their development
has been hindered by:
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poor tolerability at therapeutic doses; |
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rapid metabolism, resulting in a short half-life and, therefore,
requiring multiple daily dosing; and |
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the requirement of slow dose escalation to effective doses
because of nausea and lightheadedness, which are side effects of
azapirones believed to be due in part to their binding to
off-target GPCRs. |
Predix believes that there exists a significant unmet need and
commercial opportunity for a once daily therapy for the
treatment of anxiety and depression that avoids the sexual
dysfunction and sleep disorders associated with SSRIs, lacks the
addictive and sedative effects of the benzodiazepines, and does
not have the slow onset, short half-life, and side effects of
azapirones (most of which have failed in clinical development
due to poor tolerability at therapeutic doses). PRX-00023 was
designed as a selective, non-azapirone, 5-HT1A agonist, which
Predix believes addresses these needs.
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Using its proprietary structure-based drug discovery technology
and approach, Predix discovered, optimized and is developing
PRX-00023, a novel, non-azapirone, long acting, highly
selective, small-molecule 5-HT1A agonist for the treatment of
anxiety and depression. Predix designed PRX-00023 to have
minimal affinity for the GPCRs associated with the side effects
of 5-HT1A agonists that are in the azapirone chemical class, to
not bind to the 5-HT receptors that are believed to be
associated with the side effects of SSRIs and SNRIs, and to have
a more convenient dosing profile (i.e., a longer half-life) than
azapirones. Three Phase I clinical trials for PRX-00023
have been completed, in 110 healthy volunteers. The initial
therapeutic focus for PRX-00023 has been on the treatment of
GAD, and PRX-00023 is currently in the first of at least two
pivotal Phase III trials for the treatment of this
disorder. Enrollment for this trial began in August 2005.
Initial results are expected in the second half of 2006. Predix
completed an open-label Phase IIa clinical trial of
PRX-00023 in GAD patients in July 2005.
This clinical trial is a randomized, placebo-controlled,
double-blind, multi-center Phase III trial involving
approximately 310 subjects with
moderate-to-severe GAD.
Predix originally submitted the protocol for this trial to the
FDA in June 2005 and subsequently submitted the statistical
analysis plan for this trial to the FDA in August 2005. The
protocol design and endpoints were deemed acceptable by the FDA
in August 2005 and the statistical analysis plan was deemed
acceptable by the FDA in November 2005. The protocol provides
for patients to be randomized into one of two arms, consisting
of approximately 155 patients each: a PRX-00023 treatment
arm, in which patients receive a dose of 40 milligrams, or mg,
administered once daily over a three-day period followed by an
80 mg oral dose once daily for a total of eight weeks; or a
placebo arm. The primary objectives in this trial are to
evaluate the efficacy of PRX-00023 as measured by the change
from baseline in the Hamilton Rating Scale for Anxiety, or
HAM-A, and to assess the safety and tolerability of PRX-00023
during treatment of patients with GAD. The HAM-A scale is a
subjective measure of the severity of anxiety, and is the FDA
accepted standard for the evaluation of anti-anxiety activity.
It is used in all pivotal trials of drug candidates for the
treatment of GAD. The HAM-A is administered by the clinician who
evaluates the patient on 14 anxiety measures. Total score under
the HAM-A scale ranges from zero to 56.
Moderate-to-severe GAD
corresponds to a HAM-A score of more than 20, and a
normal level of anxiety is defined as a HAM-A score
of seven or less.
The key secondary objective of the ongoing Phase III trial
is to assess the efficacy of PRX-00023 in patients with GAD as
measured by the change from baseline in the Clinical Global
Impression Improvement score, or CGI-I. Several other
anti-anxiety metrics will be evaluated as exploratory secondary
endpoints, including responder rate, remission rate, the effect
of PRX-00023 on the Sheehan Disability scale (an indicator of
difficulties with work/school, family life and social life), its
effect on the Montgomery Asberg Depression Rating Scale, or
MADRS, its effect on the Hospital Anxiety and Depression Scale,
or HADS, its effect on sexual function, and the presence of
withdrawal symptoms, if any, after cessation of drug therapy.
Initial results from this trial are expected to be available in
the second half of 2006.
Predix intends to initiate at least one additional pivotal
Phase III trial for PRX-00023 in GAD. Predix will need
additional funding to further develop and commercialize
PRX-00023 for the treatment of GAD, and may seek to establish a
collaboration with respect to this indication. Predix also
intends to initiate clinical development of PRX-00023 for the
treatment of depression in the future, and expects to be able to
rely on the clinical trials completed to date for PRX-00023 and
begin clinical development for a depression indication with
Phase II clinical trials. Predix currently intends to seek
a collaboration to develop PRX-00023 for depression, but may
initiate such Phase II clinical trials in depression
independently using a similar dosing scheme to that described
above if circumstances allow. If Predix enters into a
collaboration with respect to PRX-00023, it is possible that any
such collaboration will involve both the GAD and depression
indications. Predix does not currently have any agreement or
arrangement with respect to any collaboration involving
PRX-00023.
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Additionally, Predix is planning to develop a commercial
formulation of PRX-00023, but is conducting its trials of
PRX-00023 with an unformulated version of the drug candidate. In
addition, the clinical path of PRX-00023 may be delayed because
Predix has less clinical data and clinical experience with
PRX-00023 than it would
have had it followed the more common practice of conducting more
than one Phase II clinical trial for
PRX-00023. Instead,
after meeting with the FDA regarding the design, endpoints and
statistical plan of the Phase III clinical trial, Predix
elected to progress
PRX-00023 directly into
Phase III development. Predix must also submit the results
of a two-year carcinogenicity study of
PRX-00023 prior to its
approval. Predix has not yet initiated this study and intends to
conduct this study prior to submitting an NDA to the FDA.
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Phase IIa Clinical Trial Results |
Predix has completed an open-label, multi-center, outpatient
Phase IIa clinical trial in 20 patients with
moderate-to-severe GAD
(i.e., a HAM-A score of 20 or higher at the initial screening).
In this trial, following a one-week single-blinded placebo run
in period (where patients did not know they were receiving
placebo), PRX-00023 was administered to patients in doses of
40 mg once daily orally for four days, followed by
80 mg once daily orally for 10 days and then
120 mg once daily orally for 14 days. The primary
objective in this trial was to assess the safety and
tolerability of PRX-00023 during short-term treatment of
patients with GAD. The secondary objectives were to evaluate the
efficacy of PRX-00023 using standard assessment tests such as
HAM-A, to evaluate the effect of PRX-00023 on remission of
anxiety and to assess the effect of PRX-00023 on the change of
the Profile of Mood State score, or POMS, from baseline.
Results from this Phase IIa clinical trial show that
PRX-00023 was well tolerated at 80 mg and 120 mg
daily, with slightly more adverse events and the only adverse
event (i.e., irritability) rated severe in intensity seen at the
120 mg dose. The most frequently reported adverse event was
flu-like symptoms, occurring in three patients. There were no
serious adverse events and only one patient discontinuation,
which was due to an adverse event that was deemed by the
treating physician not to be related to PRX-00023. In
comparison, a previously reported four week Phase II
clinical trial of the 5-HT1A agonist ipsapirone in GAD patients
showed a discontinuation rate due to severe adverse events of
31% in the high dose treatment group. In Predixs
Phase IIa clinical trial of
PRX-00023, there was no
record of any sexual dysfunction adverse events, no documented
withdrawal symptoms following cessation of PRX-00023 dosing, and
there were no significant changes with treatment of PRX-00023 in
laboratory parameters, electrocardiograms or vital signs.
Although there was no comparator treatment in this trial, the
results indicate that PRX-00023, given for four weeks,
substantially lowered measures of anxiety from baseline values,
including the HAM-A total score, HAM-A psychic subscale score,
CGI-I score and HADS score. Predixs analysis of HAM-A
scores showed that 13 of 19 patients, or 68%, were
responders, with a reduction in their HAM-A score of
at least 40% and also showed that 9 of 19 patients, or 47%,
had a reduction in their HAM-A score of at least 50%. This
response rate is consistent with that reported in clinical
development with the active drugs escitalopram (Lexapro),
venlafaxine (Effexor), paroxetine (Paxil), buspirone (BuSpar),
and diazepam (Valium) in an anxiety patient population. This
response rate is also higher than the response rates to placebo
in GAD trials, which is on average approximately 30%, as
reported in the May 2005 issue of the journal Psychological
Medicine.
Predixs analysis also showed that six of 19 patients,
or 32%, experienced remission of anxiety (i.e., a
return to normal function), with a reduction in HAM-A score to
seven or less during treatment with PRX-00023. This finding is
consistent with that observed with drugs that affect the
serotonin system, as shown recently in GAD trials with the SSRIs
escitalopram and paroxetine. In addition, results indicated that
while there was further improvement in response from week two to
week four, the majority of anti-anxiety effects of PRX-00023
occurred in the first two weeks of treatment, when patients were
dosed with 80 mg per day. This finding suggests that
PRX-00023 may have a relatively rapid onset of action compared
to that of SSRIs used to treat GAD.
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These results are based on a small number of patients in an
early-stage clinical trial and are not necessarily predictive of
results in later-stage clinical trials with larger and more
diverse patient populations.
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Phase I Clinical Trial Results |
Predix has completed three Phase I clinical trials of
PRX-00023 in a total of 110 healthy volunteers to evaluate the
tolerability and pharmacokinetics of PRX-00023. These
Phase I clinical trials included randomized,
placebo-controlled, double-blind, single and
28-day multiple-dose
escalation trials, as well as a food effect and high dose trial
in healthy volunteers. The results of these trials of PRX-00023
suggested pharmacokinetic properties suitable for once daily
oral therapy with a half-life of ten to 14 hours, and no
serious adverse events were associated with treatment. In
addition, there were no clinically meaningful changes in any
clinical laboratory tests, vital signs or electrocardiograms
during these Phase I trials.
In addition, 5-HT1A agonists of several chemical classes are
known to induce the transient, low-level release of the hormone
prolactin, which is made in the brain. While such hormonal
increases have not been reported to cause side effects,
increases in prolactin levels can be measured as a surrogate
marker of 5-HT1A stimulation in the brain. In all three of its
Phase I clinical trials, Predix measured plasma prolactin
levels as a surrogate marker for 5-HT1A activity following
administration of PRX-00023. Measurable, dose-dependent
increases in prolactin levels were found at doses greater than
10 mg. Prolactin increases with administration of 40 mg of
PRX-00023 were comparable to those measured with the highest
FDA-approved dose of buspirone administered (30 mg); in
both cases, prolactin levels returned to baseline within six
hours, showing the transient nature of this hormonal response to
5-HT1A stimulation. Doses of PRX-00023 between 60 mg and
90 mg showed maximal stimulation of prolactin with or
without food; higher doses produced no additional prolactin.
Predix believes that this finding demonstrates PRX-00023
activity through the 5-HT1A receptor and indicates that doses
between 60 mg and 90 mg can mediate optimal biological
activity. Whether this biological activity will translate
directly into clinical activity is not known. Doses as high as
150 mg once daily have been achieved without significant
side effects; a maximum tolerated dose has not been determined
to date.
In the 28-day
multiple-dose Phase I clinical trial, Predix also
administered a POMS survey, and observed trends in
tension/anxiety and anger/hostility items that were consistent
with an anti-anxiety drug.
These results are based on a small number of patients in
early-stage clinical trials and are not necessarily predictive
of results in later-stage clinical trials with larger and more
diverse patient populations.
PRX-03140 for Alzheimers Disease
PRX-03140 is a novel, highly selective, small-molecule 5-HT4
agonist that Predix is developing for the treatment of
Alzheimers disease. PRX-03140 is being developed to
provide improved cognition and to slow Alzheimers disease
progression. Predix completed a
14-day multiple-dose
Phase Ib clinical trial with
PRX-03140 in patients
with mild-to-early
moderate Alzheimers disease in September 2005. Predix has
also completed a multiple-dose Phase I clinical trial in
healthy volunteers and a single-dose escalation Phase Ia
clinical trial in healthy volunteers, including one cohort of
healthy elderly volunteers. To date, there have been no serious
adverse events associated with treatment with PRX-03140.
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Disease and Market Overview |
Alzheimers disease is a debilitating neurodegenerative
disorder characterized by progressive loss of memory and
cognitive function, affecting 4.5 million Americans
according to the Alzheimers Association, and over
9 million worldwide according to the Alzheimers
Disease International Association. The U.S. National
Institute of Aging estimates that about 5% of the population
aged 65-74 and as many as 50% of those over age 85 have the
disease. According to U.S. Census data, the 65 and older
population will double over the next 25 years, to over
70 million, when the youngest post-World War II baby
boomers turn older than 65. A recent study in the journal
Neurology showed that this growth in the elderly
162
population is expected to result in a 44% average increase in
Alzheimers disease patients in the United States by 2025.
The global market for Alzheimers disease drugs is growing
rapidly, from $3 billion in 2004 to nearly $7 billion
expected in 2010, as estimated by Espicom.
Patients with Alzheimers disease exhibit a marked
reduction in the function of neurons that produce various
neurotransmitters, particularly acetylcholine, or ACh. ACh is a
critical neurotransmitter in the brain that regulates memory and
learning. Progressive loss of function of the neurons in
memory-related areas and alteration in other mental abilities
occurs, leading to difficulties in making judgments and in
carrying out daily activities, eventually resulting in the loss
of speech and movement.
Three out of the four approved drugs for Alzheimers
disease in the United States are acetylcholinesterase
inhibitors, which exert their effect by blocking the enzyme that
degrades ACh, thereby maintaining brain levels of this key
neurotransmitter, provided that neurons are functioning
sufficiently to produce enough ACh (the other approved drug is
an antagonist of an ion channel known as the NMDA glutamate
receptor that protects against this protein becoming overexcited
by glutamate, but which also allows for normal neuron function).
Although the acetylcholinesterase inhibitors and the NMDA
antagonist provide short-term improvements in cognition and
memory, as neuronal function declines in Alzheimers
disease, they lose activity. In addition, acetylcholinesterase
inhibitors can cause significant peripheral side effects,
including nausea, vomiting, dry mouth, urinary dysfunction,
anxiety and diarrhea, believed to be due to increases in ACh
levels in peripheral organs. These peripheral side effects limit
the doses which can be administered to patients with
Alzheimers disease.
Predix believes that there is strong clinical interest and
significant potential market opportunity in developing
Alzheimers disease drugs which increase the production of
ACh in the brain without affecting the levels of ACh in the
peripheral organs.
Recent published studies by pharmaceutical companies and
academic groups suggest that stimulation of a specific GPCR in
the brain known as 5-HT4 may provide both improvement in
cognition and memory and could potentially slow disease
progression as follows:
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Improvement in cognition and memory |
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5-HT4 stimulation has been shown in pre-clinical studies to
increase ACh levels in the brain by stimulating its release
and/or production. 5-HT4 stimulation also has been shown in
animal models to improve cognitive function. |
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5-HT4 stimulation has been shown in animal models to overcome
abnormal cognitive function induced by other agents that block
ACh function, suggesting that 5-HT4 stimulation leads to an
increase in ACh production and/or release specifically in the
brain. |
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This mechanism may be complementary to that of
acetylcholinesterase inhibitors. It has been demonstrated in
pre-clinical models of Alzheimers disease by Predix and
other groups that cognition may be enhanced by either using a
5-HT4 agonist as monotherapy or in combination with
acetylcholinesterase inhibitors. |
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Slowing disease progression |
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Amyloid precursor protein, or APP, is a protein that can be cut
into smaller molecules which can stimulate Ab plaque-forming or
non-plaque-forming signaling cascades, or pathways. |
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5-HT4 stimulation may promote a pathway in APP regulation
thought to be non-plaque forming. |
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By activating this pathway, 5-HT4 stimulation has been shown in
animal models to reduce the plaque-forming Ab isoforms of APP. |
Predix believes that there exists a significant unmet need and
commercial opportunity for a therapy for Alzheimers
disease that improves cognition alone or in combination with
acetylcholinesterase inhibitors, and which has the potential to
slow disease progression. PRX-03140 was designed as a selective
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5-HT4 agonist, which Predix believes addresses these needs and
may be devoid of many of the peripheral side effects common with
most agents currently used to treat Alzheimers disease.
Using its proprietary structure-based drug discovery technology
and approach, Predix discovered, optimized and is developing
PRX-03140, a novel, highly selective, small-molecule 5-HT4
agonist for the treatment of Alzheimers disease. PRX-03140
has demonstrated cognition improvement and memory enhancement,
along with potential neuroprotective and disease-modifying
effects, in multiple pre-clinical models in several animal
species. In these in vivo studies, PRX-03140 increased
ACh levels, resulting in enhanced memory and cognition, and also
exhibited trends towards reduced Ab plaque levels and increased
sAPPa levels, demonstrating the potential to slow disease
progression. In addition, PRX-03140 also affected the
neuroprotective growth factors called NGF and BDNF. Predix
believes that PRX-03140 will be used in the clinic as either
monotherapy or in combination with the acetylcholinesterase
inhibitors that are approved for Alzheimers disease. In a
pre-clinical animal model of cognition, PRX-03140 demonstrated
synergistic activity when combined with the acetylcholinesterase
inhibitor galantamine (Razadyne).
Predix completed a
14-day Phase Ib
clinical trial in patients with
mild-to-early moderate
Alzheimers disease with PRX-03140 in September 2005.
Predix has also completed a
14-day, multiple-dose
Phase I clinical trial in healthy volunteers and a
single-dose escalation Phase I clinical trial in healthy
volunteers, including one cohort of healthy elderly volunteers.
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Planned Phase IIa Clinical Trial |
Predix is currently designing an initial Phase IIa clinical
trial of PRX-03140 for the treatment of Alzheimers
patients based on the tolerability and pharmacokinetic results
from the three Phase I clinical trials. Predix expects to
initiate this trial in the second half of 2006. Predix may
conduct this Phase IIa clinical trial and other clinical
trials for PRX-03140 independently or, if conditions at the time
favor or require, Predix may seek to establish a collaboration
with a leading pharmaceutical or biotechnology company. Predix
does not currently have any agreement or arrangement with
respect to any such collaboration.
Predix completed a
14-day Phase Ib
clinical trial of PRX-03140 in
mild-to-early moderate
Alzheimers patients to evaluate tolerability and
pharmacodynamics (i.e., the determination of the processes
through which a drug exerts the biological effect observed) in
September 2005. PRX-03140 was well tolerated in this study, with
no serious adverse events or drug-related discontinuations.
Quantitative markers of brain wave activity called
electroencephalograms, or EEGs, were acquired to examine the
pharmacodynamic effects of PRX-03140 in the brain. In
Alzheimers patients, the amount of slow-wave activity in
the EEG, known as the theta band, is increased at rest and has
been shown to be correlated with measures of Alzheimers
severity. Results from this Phase Ib clinical trial showed
that statistically significant decreases in slow-wave activity
were observed with PRX-03140 treatment relative to the effect
observed with placebo treatment. This finding is consistent with
EEG effects previously seen in short-term clinical trials with
approved drugs for Alzheimers disease that act to increase
levels of ACh in the brain. This finding also demonstrates that
PRX-03140 penetrates the human brain.
In addition, changes in cognitive scales were monitored in this
Phase Ib clinical trial, such as the Cambridge
Neuropsychological Test Automated Battery, or CANTAB, Buschke
memory test and Alzheimers Disease Assessment
Scale-cognitive subscale, or ADAS-cog. No appreciable
differences were noted in analyses of these cognitive function
test results, which is also consistent with results from several
small, short-term studies with currently approved drugs for
Alzheimers disease, where changes in cognition require
dosing from three to six months.
164
Biomarkers of 5-HT4 receptor effects, such as Ab and sAPP, were
also measured in this Phase Ib study. Trends towards
decreases in plasma levels of Ab, as well as increases in sAPP,
with PRX-03140 treatment relative to placebo treatment were
seen. Though the trends did not reach statistical significance,
the direction of change in these parameters relative to placebo
treatment was similar to findings from the pre-clinical animal
models. Predix believes that these data suggest that PRX-03140
could slow the progression of disease in Alzheimers
patients. However, the FDA has not approved any agent to date
with a label for slowing disease progression, and endpoints
required in such studies are not clear at this time. Therefore,
Predix is focusing its initial clinical development on
demonstrating the cognitive improvement of PRX-03140 alone or in
combination with acetylcholinesterase inhibitors.
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Phase I Clinical Trial Results |
Predix has completed two Phase I clinical trials with
PRX-03140 in a total of 110 healthy volunteers to evaluate its
safety, tolerability and pharmacokinetics. These Phase I
clinical trials were randomized, placebo-controlled,
double-blind, single and multiple-dose escalation studies. The
single-dose escalation study evaluated doses ranging from
5 mg to 250 mg. This study included one cohort of
healthy elderly volunteers (65-80 years old). The
multiple-dose escalation study evaluated daily dosing of
10 mg to 200 mg for 14 days and incorporated
measurements of biomarkers for 5-HT4 agonist activity, such as
aldosterone.
The Phase I multiple-dose clinical trial results for
PRX-03140 suggest pharmacokinetic properties suitable for once
daily oral therapy with a half-life of nine to 13 hours.
Over a dose range of up to 250 mg, which was the maximum
dose tested in the single-dose escalation study, PRX-03140 was
well-tolerated, and there were no serious adverse events
associated with treatment with PRX-03140. Therefore, a maximum
tolerated dose of PRX-03140 has not been determined. In the
multiple dose trial, with doses of 200 mg taken by mouth
once daily for 14 days, there were no serious adverse
events. Three of the 6 volunteers taking this dose reported
vivid dreams, which have also been reported in
patients taking other drugs that increase ACh levels in the
brain. In addition, because a hormone called aldosterone is
known to increase in response to 5-HT4 stimulation in humans,
aldosterone was measured in the Phase I trials as a
surrogate marker of 5-HT4 activity. In the Phase I trials,
PRX-03140 caused the expected, dose-dependent, transient
increase of aldosterone within normal levels, consistent with
the effects of other 5-HT4 agonists on this hormone.
These results are based on a small number of patients in
early-stage clinical trials and are not necessarily predictive
of results in later-stage clinical trials with larger and more
diverse patient populations.
PRX-08066 for Pulmonary Hypertension
PRX-08066 is a novel, highly selective, small-molecule 5-HT2B
antagonist that Predix is developing for the treatment of PAH
and PH associated with COPD. PRX-08066 is being developed to
provide both symptomatic improvement and to slow disease
progression. Predix has completed three Phase I clinical
trials in healthy volunteers and to date, there have been no
serious adverse events associated with treatment with PRX-08066.
One of these clinical trials was a Phase Ib trial in
athletes conditioned to exercise at high altitudes with PH that
was induced by breathing low levels of oxygen. Preliminary
results from the Phase Ib trial indicate that PRX-08066
given twice daily caused a statistically significant reduction
in the pulmonary blood pressure that is elevated during exercise
at reduced oxygen levels, compared to placebo.
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Disease and Market Overview |
Pulmonary arterial hypertension, or PAH, is a serious, often
fatal cardiovascular disease characterized by elevation of
pulmonary artery blood pressure and progressive thickening and
narrowing of the blood vessels of the lungs, which can lead to
heart failure. Like other heart failure syndromes, symptoms of
PAH include fatigue after minimal exertion, dizzy spells, chest
pain, shortness of breath and fainting. Predix
165
believes that PAH afflicts nearly 50,000 people in the United
Staes and 50,000 in Europe. According to Datamonitor, the global
market for PAH drugs is growing rapidly, from over
$800 million in 2005 to an estimated $1.8 billion in
2010, as more patients with PAH are diagnosed and initiated on
drug therapy.
According to Datamonitor, PH is estimated to be present in
approximately 15-20% of patients who have chronic obstructive
pulmonary disease, or COPD, a progressive lung disease affecting
nearly 30 million people worldwide which is characterized
by airflow obstruction that interferes with normal breathing and
impairs the ability to exercise and perform daily activities.
There are currently no approved drugs for the treatment of PH
associated with COPD.
PAH results from the accelerated proliferation of
blood-vessel-associated smooth muscle cells that leads to the
growth and thickening (i.e., constriction) of pulmonary
arteries. Blood supply for the lungs is mediated by contraction
of the right ventricle in the heart. The right ventricle can
accommodate normal pulmonary blood pressures, but is poorly
suited to tolerate the increased pulmonary pressures associated
with arterial constriction that occur in PAH. Over time, as the
right ventricle loses the ability to pump blood into the
hypertensive pulmonary system, the right ventricle heart muscle
weakens and becomes enlarged and dilated, eventually leading to
heart failure.
Currently approved treatments for PAH include prostacyclin
analogs, an endothelin receptor antagonist and a
phosphodiesterase-5 inhibitor, all of which relieve disease
symptoms by reducing pulmonary artery blood pressure.
Prostacyclin analogs are mainly administered by intravenous or
subcutaneous infusions using complicated delivery systems or as
inhalation solutions. The only endothelin receptor antagonist
currently approved for the treatment of PAH is orally
administered. Endothelin receptor antagonists as a class may,
however, cause liver toxicity, and the currently approved drug
in this class for the treatment of PAH requires patients to
undergo monthly liver function blood tests. In addition, the
prostacyclins and the endothelin receptor antagonist may not be
used at optimal doses due to their lack of selectivity for
pulmonary vessels, which can result in reductions in systemic
blood pressure, causing patients to become lightheaded, dizzy
and fatigued. Moreover, because these current treatments do not
directly target pulmonary artery smooth muscle cell
proliferation that occurs during PAH, they are limited in their
ability to slow progression of the disease. The long-term
efficacy, maintenance dose, disease modification properties and
mortality benefits of the newly approved phosphodiesterase-5
inhibitor are not yet known.
The role of a GPCR known as 5-HT2B in PAH has recently been
characterized, and this protein has been implicated in PAH
caused by diet drugs, whose metabolites are potent and selective
activators or agonists of 5-HT2B. 5-HT2B receptors are
selectively expressed to a higher level in pulmonary arteries of
patients with PAH compared with 5-HT2B levels in normal
pulmonary arteries. Recent studies in animal models have shown
that 5-HT2B antagonists selectively open, or dilate, diseased
pulmonary vessels but do not affect normal pulmonary or systemic
vessels, thus potentially providing improved exercise capacity
in PAH patients without the risk of reductions in systemic blood
pressure. 5-HT2B antagonists have also been shown to slow
disease progression in animal models of PAH by blocking the
smooth muscle cell proliferation that leads to progressive
thickening of pulmonary vessels as PAH worsens.
Predix believes that there exists a significant unmet need and
commercial opportunity for the treatment of PAH and PH
associated with COPD. PRX-08066 has the potential to address
this need through its effect on the 5-HT2B receptor, which
Predix believes may result in dilation of diseased pulmonary
arteries and inhibition of pulmonary vessel thickening.
Using its proprietary structure-based drug discovery technology
and approach, Predix discovered, optimized and is developing
PRX-08066, a novel, highly selective, small-molecule 5-HT2B
antagonist for the treatment of PAH and PH associated with COPD.
PRX-08066 is being developed to provide both symptomatic
improvement through selective dilation of diseased pulmonary
blood vessels and to also slow disease progression by inhibiting
the thickening of the pulmonary artery vessels. Unlike many
commonly used vasodilators, PRX-08066 is selective for the
pulmonary vessels and shows no effect on systemic blood
166
pressures. Thus, PRX-08066 has demonstrated selective pulmonary
vessel dilation in both acute and chronic animal models of PAH,
as well as potential disease-modifying effects in vitro
biochemical pathway studies. In pre-clinical studies,
PRX-08066:
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caused rapid reductions in pulmonary blood pressure in
hypoxia-induced mouse and rat models of PAH without affecting
normal pulmonary or systemic blood pressures; |
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reduced the hypoxia-dependent increase in pulmonary blood
pressure in a rat model of short-term hypoxia without altering
systemic blood pressure, suggesting a role for PRX-08066 in the
treatment of acute mountain sickness and hypoxia-induced
PH; and |
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potently blocked the function of an enzyme named
mitogen-activated protein, or MAP kinase, which has been linked
to the proliferation of blood-vessel-associated smooth muscle
cells leading to the progression of PAH. |
Because of the selectivity it has shown for hypoxia-induced PH
in pre-clinical studies, Predix believes that PRX-08066 should
lack the systemic blood pressure issues of currently approved
therapies for PAH, and PRX-08066 may be a suitable treatment for
PH associated with chronic lung disease. Predix has completed
three Phase I clinical trials of PRX-08066 in healthy
volunteers, including a Phase Ib trial in athletes
conditioned to exercise at high altitudes with PH that has been
induced by a forced lack of oxygen.
Predix has completed a Phase Ib clinical trial to study the
pharmacodynamics and tolerability of PRX-08066 in 15 adults
conditioned to exercise at high altitudes, with elevated
pulmonary artery pressures induced by low oxygen levels
(hypoxia). This trial explored the effects of PRX-08066 on
pulmonary blood pressure and exercise capacity during hypoxic
challenges in athletic adults who are conditioned to low oxygen
pressure environments, such as high altitudes. Because of their
conditioning at high altitudes, these volunteers are able to
tolerate increases in pulmonary pressures when challenged with
inhalation of hypoxic gas mixtures.
This Phase Ib trial featured a randomized, double-blind,
three-period crossover design, where each subject received drug
or placebo twice daily for three days in three separate periods,
with an interval of one to two weeks between visits. During each
dosing day, subjects were challenged with hypoxic conditions for
90 minutes to induce increases in pulmonary blood pressure. The
pharmacodynamics of PRX-08066 were characterized by the
noninvasive measurement of pulmonary artery blood pressure,
cardiac index (i.e., volume of blood pumped by the heart per
minute indexed to body size) and exercise capacity using an
echocardiogram, or heart ultrasound. Ten of the 15 subjects who
received at least one dose of PRX-08066 completed all phases of
the trial and were included in this analysis.
Preliminary results from this Phase Ib trial show that a
reduction in the systolic pulmonary blood pressure during
resting hypoxia and during exercise hypoxia was observed with
PRX-08066 treatment, at a dose level of 200 mg given orally
bid (twice daily), compared to placebo. This dose level resulted
in a statistically significant, 40% reduction in the
hypoxia-induced increase in pulmonary blood pressure compared to
placebo during hypoxia exercise (day one data pooled with day
three data).
There was no obvious effect of PRX-08066 on cardiac index or
exercise capacity. Based on the good tolerability of PRX-08066
and its effect to reduce pulmonary blood pressure within three
days of dosing in this Phase Ib trial, Predix expects to
initiate a Phase IIa clinical trial in PH associated with
COPD in the second half of 2006.
Predix has completed two Phase I clinical trials in healthy
volunteers to evaluate the safety and tolerability of PRX-08066
and to obtain pharmacokinetic data. The first Phase I
clinical trial was a randomized, placebo-controlled,
double-blind, single-dose escalation study with 40 subjects.
Over a dose
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range from 25 mg to 500 mg, PRX-08066 was
well-tolerated; nausea was seen at the 800 mg dose. There
were no serious adverse events or liver toxicity issues
associated with treatment.
The second Phase I clinical trial was a
14-day, multiple-dose
study of PRX-08066 in healthy volunteers to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of
PRX-08066. Over a dose range of 25 mg once daily to
400 mg twice daily, PRX-08066 was well-tolerated, and there
were no serious adverse events or liver toxicity associated with
treatment. Pharmacokinetic data from the two Phase I
studies is consistent with once or twice daily oral dosing.
Predixs Pre-clinical and Discovery Programs
In addition to its three clinical-stage drug candidates, Predix
has ongoing pre-clinical and discovery programs for a broad
variety of GPCR and ion channel drug targets. Predix is also
expanding its structure-based technologies to investigate
additional membrane protein types as drug targets. The following
table shows the status of Predixs pre-clinical and
discovery-stage programs as of April 2006:
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Drug |
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Target |
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Proposed Indication |
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Mechanism of Action | |
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Stage |
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Status |
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5-HT6
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Obesity, cognitive impairment |
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GPCR antagonist |
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IND-enabling toxicology |
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IND filing for PRX-07034 expected in 2006 |
Kv1.5
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Atrial fibrillation |
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Ion channel antagonist |
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Lead optimization(1) |
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Efficacy shown in in vitro heart muscle cells |
S1P-1
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Inflammation, cancer |
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GPCR modulator |
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Lead optimization(1) |
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Efficacy shown in in vivo animal models |
CCR-2
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Inflammation, rheumatoid arthritis |
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GPCR modulator |
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Lead discovery(2) |
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In silico screening using 3D structure ongoing |
CB-1
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Obesity, pain |
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GPCR modulator |
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Lead discovery(2) |
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In silico screening using 3D structure ongoing |
P2Y(2)
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Cystic Fibrosis |
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GPCR agonist |
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Modeling(3) |
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In silico 3D structure modeling |
CFTR
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Cystic Fibrosis |
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Ion channel modulator |
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Modeling(3) |
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In silico 3D structure modeling |
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(1) |
Lead optimization is the process of chemical
modification of a lead compound to produce a drug candidate that
can enter into pre-clinical and clinical development. |
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(2) |
Lead discovery is the process of identifying
compounds that have affinity for the target protein and have
suitable drug-like properties. |
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Modeling is the process of predicting in silico the
3D structure of the target GPCR or ion channel protein. |
Predix expects that PRX-07034, a novel, highly selective,
small-molecule 5-HT6 antagonist being developed for the
treatment of obesity and also for cognitive impairment
(associated with Alzheimers disease or schizophrenia),
will be its next drug candidate to enter clinical trials.
PRX-07034 has shown cognitive-enhancing properties in
pre-clinical animal models of memory impairment, as well as
significant reductions of both food intake and body weight in
pre-clinical animal models of obesity. PRX-07034 is currently in
toxicology studies that Predix believes will enable the
submission of an IND to the FDA in 2006.
168
Predixs Drug Discovery Technology and Approach
Structure-based approaches to drug discovery can be more
efficient and cost effective than traditional drug discovery
methods. For example, the HIV protease inhibitors were launched
within eight years of initiation of the programs using
structure-based approaches, compared to an average drug
development time of between ten to 15 years using
traditional approaches. To date, these benefits have been
limited for GPCR and ion channel drug programs because of the
inability of todays experimental methods, such as X-ray
crystallography, to determine the structure of these
membrane-bound drug targets. Predix has developed a novel and
unique in silico protein structure-based approach to GPCR
and ion channel-targeted drug discovery that allows it to
benefit from the structure-based approach in the absence of
experimentally determined structures for these targets.
Predixs PREDICT technology combines genomic information
(the amino acid sequence of the target protein) with physical
and chemical properties of the cell membrane environment to
predict what structure it determines to be the most stable 3D
structure of a membrane-bound protein. Predixs PREDICT
technology leads to the 3D structure of the target protein and
thus is the foundation and first step in its novel system of
discovery and optimization for GPCR and ion channel-targeted
drugs. Predix has maintained its GPCR and ion channel structures
as trade secrets, which Predix believes, when combined with its
proprietary software and know-how required to use the PREDICT
technology, creates a strong barrier to entry for Predixs
competitors.
Using Predixs proprietary drug discovery technology and
approach requires the successive application of the following
five steps: (1) using the PREDICT technology to construct a
representation of the 3D structure of the desired GPCR or ion
channel drug target, bypassing the need for X-ray
crystallography, (2) analyzing the resulting structure and
identifying a potential site on the target structure for drug
interaction, (3) performing in silico screening
using the computer to fit more than two million drug-like
compounds into this drug site, ensuring that both the shape and
chemical properties match, (4) selecting the 100-200
compounds that best match the drug site on the target and
testing their activity in vitro in the laboratory
and (5) identifying the most active and novel chemical
compounds, referred to as lead compounds, and then subjecting
these lead compounds to an integrated structure-based lead
optimization process. The PREDICT-generated 3D structure of the
target protein as well as other 3D protein structures (many of
which are also generated by PREDICT) are used to steer lead
optimization along the most efficient path, transforming lead
compounds into drug candidates expeditiously. Predixs
discovery and optimization process is outlined in the following
steps:
PREDICT-3D in silico modeling. Predix has developed novel
proprietary algorithms which it uses in its PREDICT technology
to model the 3D structure of most GPCR from its primary amino
acid sequence. PREDICT uses algorithms that explore a large
number of possible structures of the GPCR target and then
selects the structure it determines to be most biologically
relevant. It takes into account specific interactions between
the GPCR protein and the membrane, specific interactions within
the GPCR protein itself, and addresses the limitations that
hamper homology-based modeling of GPCRs. The PREDICT software
code and many of its algorithms are kept as trade secrets,
making it difficult to copy or reverse-engineer. Predix filed
patents on PREDICT version 1.0 in 2000, and the current version
of PREDICT is highly advanced and includes numerous new
algorithms and capabilities. PREDICT bypasses the need for X-ray
crystallography structures of GPCRs to initiate a
structure-based discovery program for this class of targets.
Virtual libraries. Predixs libraries consist of
virtual versions of more than two million drug-like compounds
which are available for purchase from commercial vendors
worldwide. These virtual libraries reduce the need for Predix to
synthesize or purchase, store and maintain tens or hundreds of
thousands of actual compounds for the initial screening.
Rapid in silico screening. The process of in silico
screening requires the computer to perform trillions of
operations in trying to fit numerous drug-like compounds into
the drug site of the target protein, matching both shape and
chemical properties. Predix performs high-throughput in
silico screening with a combination of proprietary and
public software to identify compounds that may bind to a target
GPCR or ion channel.
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Ranking of screening results. Predix has developed
proprietary algorithms for ranking its in silico
screening results using internally developed tools, which
Predix believes enables it to select the 100-200 most promising
compounds for in vitro testing.
Integrated structure-based lead optimization. The most
promising novel lead compounds, identified in silico and
shown to have binding affinity and functionality
in vitro, are optimized into drug candidates using
an integrated structure-based approach. This process makes use
of the PREDICT 3D structures (of the drug target and related
off-target proteins) as well as many other in silico
tools that Predix has created to enable efficient
structure-based lead optimization, leading to highly selective
drug candidates. Predix believes that these tools help overcome
challenges frequently encountered during lead optimization, such
as selectivity, blood-brain barrier penetration and hERG ion
channel binding, reducing the time and cost compared to
traditional lead optimization efforts. Using these in silico
tools, Predixs computational and medicinal chemists
are able to select for actual synthesis the most promising
subset of suggested compounds. In each of its clinical-stage
programs, this approach has allowed Predix to synthesize less
than 10% of the compounds than it believes would have been
synthesized if Predix were to follow the traditional methods of
lead optimization.
Using its proprietary technology and approach, Predix was able
to repeatedly optimize lead compounds to drug candidates on
timelines of no more than 12 months, with fewer than 100
compounds synthesized per program during lead optimization.
Predix has successfully optimized lead compounds to drug
candidates in three distinct GPCR programs within these
specified parameters:
PRX-00023: Predix optimized PRX-00023, the novel, highly
selective 5-HT1A agonist that it is developing for the treatment
of anxiety and depression, from the initial in silico
lead in less than six months with only 31 compounds
synthesized.
PRX-03140: Predix optimized PRX-03140, the novel, highly
selective 5-HT4 agonist that it is developing for the treatment
of Alzheimers disease, from the initial in silico
lead in eight months with fewer than 50 compounds
synthesized.
PRX-08066: Predix optimized PRX-08066, the novel, highly
selective 5-HT2B antagonist that it is developing for the
treatment of PAH and PH associated with COPD, from the initial
in silico lead in ten months with fewer than
80 compounds synthesized.
In each of these programs, Predix was able to move from lead
identification to clinical trials in less than 18 months.
Although Predixs drug discovery capabilities and approach
have not been applied to all types of GPCRs or ion channels that
are targeted for therapeutics, Predix believes that its
technology and approach to drug discovery is applicable to most
types of GPCRs and ion channels.
Technology License Agreement with Ramot
Predixs proprietary drug discovery technology and approach
is in part embodied in technology that it licenses from Ramot at
Tel Aviv University Ltd., the technology transfer company of Tel
Aviv University. Pursuant to this license, Predix has exclusive,
worldwide rights to certain technology developed at Tel Aviv
University to develop, commercialize and sell products for the
treatment of diseases or conditions in humans and animals. The
licensed technology, as continually modified and enhanced by
Predix, consists in large part of computer-based models of
biological receptors and methods of designing drugs to bind to
those receptors.
All of Predixs current clinical-stage drug candidates,
PRX-00023, PRX-03140 and PRX-08066, were identified,
characterized or developed using the licensed technology, and
Predix would be required to make payments to Ramot, as described
below, if rights to any such drug candidates are ever
sublicensed or commercialized. In addition, Predix has used the
licensed technology in all of its pre-clinical-stage programs,
except for the atrial fibrillation program, and would expect to
make payments to Ramot if rights to any drug candidates were
ever commercialized from any of these programs.
Predix paid Ramot an upfront fee of $40,000 upon the grant of
the license. Under the license, Predix has an obligation to make
royalty payments to Ramot on its net sales of products that are
identified,
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characterized or developed through the use of the licensed
technology that are either 1.5% or 2.5% of such net sales
(depending upon the degree to which the product needed to be
modified after being identified, characterized or developed
through the use of the licensed technology) and decrease as the
volume of sales increases. The royalty obligation for each
product expires on a country-by-country basis twelve years after
the first commercial sale. There is also an annual minimum
royalty payment obligation of $10,000 per year due
beginning December 31, 2005.
Predix is also required to share between 5% and 10% of the
consideration that it receives from parties to whom Predix
grants sublicenses of rights in the Ramot technology or
sublicenses of rights in products identified, characterized or
developed with the use of such technology and between 2% and 4%
of consideration that it receives from performing services using
such technology. As such a sublicense, in connection with
Predixs collaboration with Cystic Fibrosis Foundation
Therapeutics Incorporated, Predix paid $100,000 of the
$2 million upfront payment to Ramot.
The license may be terminated by either party upon a material
breach by the other party unless cured within 30 days, in
the case of a payment breach, and 90 days in the case of
any other breach. The license may also be terminated by either
party in connection with the bankruptcy or insolvency of the
other party. The license expires upon the expiration of
Predixs obligation to make payments to Ramot. Therefore,
because Predix has an ongoing obligation to pay annual minimum
royalties to Ramot as described above, the license may not
expire and may only terminate upon a breach by, or bankruptcy
of, a party.
Collaboration with Cystic Fibrosis Foundation Therapeutics
Incorporated
In March 2005, Predix entered into a research, development and
commercialization agreement with Cystic Fibrosis Foundation
Therapeutics Incorporated, or CFFT, the drug discovery and
development affiliate of the Cystic Fibrosis Foundation. To
date, Predix has received $4.8 million from CFFT under this
agreement, consisting of a $2.0 million upfront payment and
$2.8 million of reimbursed research and development costs.
To date, Predix has not received any milestone payments under
the agreement. Including the payments already received, Predix
may receive up to an aggregate of $12.5 million from CFFT
under this agreement. The agreement involves two development
programs as follows:
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The first program is focused on the defective Cystic Fibrosis
Transmembrane conductance Regulator, or CFTR, ion channel
protein. Predix is using its proprietary structure-based
technologies to model the structure of this ion channel and
identify sites in the channel for therapeutic intervention. Once
these sites are identified, Predix aims to use its drug
discovery capabilities to discover a drug that restores proper
functionality to the channel in patients with cystic fibrosis.
If the preliminary program is successful, Predix and CFFT have
agreed to negotiate towards a follow-on agreement under which
Predix will explore a structure-based approach for the discovery
and commercialization of a drug that will target CFTR, with the
financial support of CFFT and subject to a royalty payable to
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The second program is focused on the discovery of a
small-molecule agonist to the GPCR known as P2Y(2), which plays
a role in cystic fibrosis, using Predixs proprietary
structure-based drug design system. Predix retains the right to
develop and commercialize any drug candidates discovered through
this second program, and are obligated to make aggregate royalty
payments of up to $15 million to CFFT for the first drug
candidate that reaches particular regulatory and sales
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The agreement expires with respect to the first program on
March 7, 2008 and with respect to the second program on
March 7, 2007, unless extended by the parties or terminated
by either party beforehand. In addition, funding of the first
program was scheduled to terminate on March 7, 2006 if
Predix did not achieve certain technical milestones by such
date. CFFT is currently reviewing the progress of the first
program to determine if $1.0 million of the remaining
$7.7 million of potential funding will be provided to
Predix. CFFT may terminate either or both programs without cause
upon 120 days notice or if Predix suspends or discontinues
its business. Either party may terminate the agreement for an
uncured material breach.
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Competition
Predix faces, and will continue to face, intense competition
from pharmaceutical and biotechnology companies, as well as
numerous academic and research institutions and governmental
agencies engaged in drug discovery activities or funding, both
in the United States and abroad. Some of these competitors are
pursuing the development of drugs that target the same diseases
and conditions that Predix is targeting for its clinical and
pre-clinical programs. Even if Predix and its collaborators are
successful in developing Predixs clinical-stage
candidates, the resulting products will compete with a variety
of established drugs.
Significant competitors in the area of GPCR-focused drug
discovery include Arena Pharmaceuticals, Acadia Pharmaceuticals
and 7TM Pharma, and for ion channels Predixs competitors
include Icagen, Cardiome and Vertex Pharmaceuticals. In
addition, most large pharmaceutical companies have drug
discovery programs that target GPCRs and ion channels.
Many of Predixs competitors have significantly greater
financial, manufacturing, marketing and product development
experience and resources than Predix. These companies also have
significantly greater research and development capabilities than
Predix, and significantly greater experience than Predix in
pre-clinical and clinical trials of potential pharmaceutical
products, and in obtaining FDA and other regulatory clearances.
Predixs commercial opportunity will be reduced or
eliminated if its competitors develop and commercialize products
that are safer, more effective, have fewer side effects or are
less expensive than any products that Predix may develop.
If Predixs three clinical-stage drug candidates are
approved, they will compete with currently approved drugs and
potentially with drug candidates currently in development for
the same indications, including the following:
PRX-00023. If approved, PRX-00023, the drug candidate
that Predix is developing for the treatment of anxiety and
depression, will compete with approved products from such
pharmaceutical companies as Forest Laboratories,
GlaxoSmithKline, Pfizer and Wyeth, and may compete with drug
candidates in clinical development from other companies,
including Eli Lilly and MediciNova. Predix believes that there
are over 35 drug candidates in clinical trials or that have
been submitted for approval for the treatment of anxiety and
over 45 drug candidates in clinical trials or that have
been submitted for approval for the treatment of depression.
PRX-03140. If approved, PRX-03140, the drug candidate
that Predix is developing for the treatment of Alzheimers
disease, will compete with approved products from such
pharmaceutical companies as Forest Laboratories,
Johnson & Johnson, Novartis and Pfizer, and may compete
with drug candidates in clinical development from other
companies, including Myriad Genetics and Neurochem. Predix
believes that there are over 60 drug candidates in clinical
trials for the treatment of Alzheimers disease.
PRX-08066. If approved, PRX-08066, the drug candidate
that Predix is developing for the treatment of PAH and PH
associated with COPD, will compete with approved products from
such pharmaceutical companies as Actelion, CoTherix,
GlaxoSmithKline, Pfizer and United Therapeutics, and may compete
with drug candidates in clinical development by other companies,
such as Encysive Pharmaceuticals and Myogen. Predix believes
that there are approximately ten drug candidates in clinical
trials or that have been submitted for approval for the
treatment of PAH and/or PH associated with COPD.
In each of Predixs development programs addressing
indications for which there are therapies available, Predix
intends to complete clinical trials designed to evaluate the
potential advantages of its drug candidates as compared to or in
conjunction with the current standard of care. Key
differentiating elements affecting the success of all of
Predixs drug candidates are likely to be their efficacy
and safety and side-effect profile compared to commonly used
therapies. In addition, many patents covering commercial
products for these indications will expire within the next four
to nine years, which will result in greater competition in these
indications resulting from companies producing generic versions
of the commercial drugs.
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Marketing, Sales and Distribution
Predix currently has no marketing, sales or distribution
capabilities. To commercialize any of its drug candidates,
Predix must develop these capabilities internally or through
collaboration with pharmaceutical or biotechnology companies. In
selected indications where Predix believes that its products can
be commercialized by a specialty sales force that calls on a
limited but focused group of physicians, Predix may
commercialize its products in the United States. For example,
Predix believes that pulmonary and cardiology specialists who
treat pulmonary hypertension, and the centers in which they
practice, are sufficiently concentrated to enable Predix to
effectively promote PRX-08066, if approved by the FDA, to this
market in the United States. with a small internal sales force.
In therapeutic areas that require a large sales force selling to
a large and diverse prescribing population and for markets
outside of the United States, Predix plans to establish
collaborations with pharmaceutical or biotechnology companies
for commercialization of its drug candidates.
Manufacturing
Predix outsources and plans to continue to outsource
manufacturing responsibilities to third parties for its existing
and future drug candidates for clinical development and
commercial purposes. Small amounts of material used for
pre-clinical research and development purposes are synthesized
in-house. The production of Predixs drug candidates
PRX-00023, PRX-03140 and PRX-08066 uses small-molecule synthetic
organic chemistry procedures that are standard in the
pharmaceutical industry. Predix is currently working with
contract manufacturers to produce sufficient quantities of the
active pharmaceutical ingredient in each of its programs for its
planned clinical trials in 2006. If one of Predixs
manufacturers should become unavailable to it for any reason,
Predix believes that there are a number of potential
replacements as its processes are not manufacturer-specific,
though Predix may incur some added cost and delay in identifying
or qualifying such replacements, including delays associated
with the need for FDA review and approval of the new
manufacturer, as well as those associated with the new
manufacturers ability to establish the manufacturing
process.
PRX-00023, PRX-03140 and PRX-08066 are manufactured in a
straightforward synthetic process from readily available
starting materials. There are no complicated chemistries or
unusual equipment required in the manufacturing process of these
drug candidates.
PRX-00023, PRX-03140 and PRX-08066 are all currently
administered as unformulated drug products. A commercially
viable formulation will need to be developed, manufactured and
certified for each of these drug candidates. The final
commercial formulation may not prove to be bioequivalent to the
current formulation. This may result in the need to initiate
additional clinical trials to define new dosing regimes.
Furthermore, the development and implementation of a new
formulation and commercial process for cGMP manufacturing may
add significant delays to additional clinical trials, regulatory
filings and commercial launch.
Intellectual Property
Predix actively seeks to protect the proprietary technology that
it considers important to its business, including chemical
species, compositions and formulations, their methods of use and
processes for their manufacture, as new intellectual property is
developed. In addition to seeking patent protection in the
United States, Predix plans to selectively file patent
applications in certain additional foreign countries in order to
further protect the inventions that Predix considers important
to the development of its foreign business. Predix also relies
upon trade secrets and contracts to protect its proprietary
information.
As of April 7, 2006, Predixs patent portfolio
included a total of 17 pending patent applications in the United
States as well as counterpart applications in certain foreign
countries having composition of matter, method of use and
process claims related to Predixs programs. PRX-00023 is
the subject of one pending patent application filed in 20
jurisdictions since 2004. PRX-03140 is the subject of three
pending patent applications filed in six jurisdictions since
2004. PRX-08066 is the
subject of the U.S. Patent 7,030,240, and two other pending
patent applications filed in 21 jurisdictions since 2004.
PRX-07034 is the subject of
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two pending patent applications filed in two jurisdictions.
Predix owns all of these patent applications, and Predix also
exclusively licenses technology embodied in patent applications
from Ramot at Tel Aviv University Ltd., the technology transfer
company of Tel Aviv University. Predix does not yet have any
issued U.S. patents covering its technology, but any
patents that do issue will have patent terms that will expire no
earlier than 2023.
In addition to patents, Predix relies where necessary upon
unpatented trade secrets and know-how and continuing
technological innovation to develop and maintain its competitive
position. Predix seeks to protect its proprietary information,
in part, using confidentiality agreements with its
collaborators, employees and consultants and invention
assignment agreements with its employees. These agreements may
be breached, and Predix may not have adequate remedies for any
breach. In addition, Predixs trade secrets may otherwise
become known or be independently discovered by competitors. To
the extent that Predixs collaborators, employees and
consultants use intellectual property owned by others in their
work for Predix, disputes may arise as to the rights in related
or resulting know-how and inventions.
Government Regulation and Product Approval
The FDA and comparable regulatory agencies in state and local
jurisdictions and in foreign countries impose substantial
requirements upon the clinical development, manufacture and
marketing of pharmaceutical products. These agencies and other
federal, state and local entities regulate, among other things,
the testing, manufacture, quality control, safety,
effectiveness, labeling, storage, record keeping, advertising
and promotion of Predixs products. Failure to comply with
regulatory requirements may result in criminal prosecution,
civil penalties, recall or seizure of products, total or partial
suspension of production or injunction, as well as other actions
that could affect Predixs product candidates or Predix.
Any failure to comply with regulatory requirements, to obtain
and maintain regulatory approvals, or any delay in obtaining
regulatory approvals could materially adversely affect
Predixs business.
The process required by the FDA before drugs may be marketed in
the United States generally involves the following:
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submission of an investigational new drug application, or IND,
which must become effective before human clinical trials may
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adequate and well-controlled human clinical trials to establish
the safety and efficacy of the proposed drug for its intended
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The testing and approval process requires substantial time,
effort and financial resources, and Predix cannot be certain
that any approvals for any of its drug candidates will be
granted on a timely basis, if at all.
Once a pharmaceutical candidate is identified for development it
enters the pre-clinical testing stage. During pre-clinical
studies, laboratory and animal studies are conducted to show
biological activity of the drug candidate in animals, both
healthy and with the targeted disease. Also, pre-clinical tests
evaluate the safety of drug candidates. Pre-clinical tests must
be conducted in compliance with good laboratory practice
regulations. In some cases, long-term pre-clinical studies are
conducted while clinical studies are ongoing.
Prior to commencing a clinical trial, Predix must submit an IND
to the FDA. The IND automatically becomes effective 30 days
after receipt by the FDA, unless the FDA, within the
30-day time period,
raises concerns or questions about the conduct of the trial. In
such a case, the IND sponsor and the FDA must resolve any
outstanding concerns before the clinical trial can begin.
Predixs submission of an IND may not result in FDA
authorization to commence a clinical trial. All clinical trials
must be conducted under the supervision of one or more qualified
investigators in accordance with good clinical practice
regulations. These regulations include the requirement that all
subjects provide informed consent. Further, an institutional
review board, or IRB, at each institution participating in the
clinical trial must review and approve the plan for any clinical
trial before it commences at that institution. Progress reports
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detailing the results of the clinical trials must be submitted
at least annually to the FDA and more frequently if adverse
events or other certain types of other changes occur.
Human clinical trials are typically conducted in three
sequential phases that may overlap:
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Phase I: The drug is initially introduced into
healthy human subjects or patients with the disease and tested
for safety, dosage tolerance, absorption, metabolism,
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Phase II: Involves studies in a limited patient
population to identify possible adverse effects and safety
risks, to preliminarily evaluate the efficacy of the product for
specific targeted diseases and to determine dosage tolerance and
optimal dosage. |
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Phase III: Clinical trials are undertaken to further
evaluate dosage, clinical efficacy and safety in an expanded
patient population at geographically dispersed clinical study
sites. These studies are intended to establish the overall
risk-benefit ratio of the product and provide, if appropriate,
an adequate basis for product labeling. |
In the case of some products for severe or life-threatening
diseases, especially when the product may be too inherently
toxic to ethically administer to healthy volunteers, the initial
human testing is often conducted in patients. Because these
patients already have the target disease, these studies may
provide initial evidence of efficacy traditionally obtained in
Phase II clinical trials, and thus these trials are
frequently referred to as Phase I/ II clinical trials.
The FDA or an IRB or the sponsor may suspend a clinical trial at
any time on various grounds, including a finding that the
subjects or patients are being exposed to an unacceptable health
risk.
Concurrent with clinical trials and pre-clinical studies,
companies also must develop information about the chemistry and
physical characteristics of the drug and finalize a process for
manufacturing the product in accordance with cGMP requirements.
The manufacturing process must be capable of consistently
producing quality batches of the product candidate and the
manufacturer must develop methods for testing the quality,
purity and potency of the final drugs. Additionally, appropriate
packaging must be selected and tested and stability studies must
be conducted to demonstrate that the product candidate does not
undergo unacceptable deterioration over its shelf-life.
The results of product development, pre-clinical studies and
clinical studies, along with descriptions of the manufacturing
process, analytical tests conducted on the chemistry of the
drug, results of chemical studies and other relevant information
are submitted to the FDA as part of an NDA requesting approval
to market the product. The FDA reviews all NDAs submitted before
it accepts them for filing. It may request additional
information rather than accept an NDA for filing. In this event,
the NDA must be resubmitted with the additional information. The
resubmitted application also is subject to review before the FDA
accepts it for filing. Once the submission is accepted for
filing, the FDA begins an in-depth review of the NDA. The
submission of an NDA is subject to the payment of user fees, but
a waiver of such fees may be obtained under certain
circumstances. The FDA may refuse to approve an NDA if the
applicable regulatory criteria are not satisfied or may require
additional clinical or other data. Even if such data is
submitted, the FDA may ultimately decide that the NDA does not
satisfy the criteria for approval. Once an approval is granted,
the FDA may withdraw the approval if compliance with regulatory
standards is not maintained or if problems occur after the
product reaches the market. In addition, the FDA may require
testing and surveillance programs to monitor the effect of
approved products that have been commercialized, and the FDA has
the power to prevent or limit further marketing of a product
based on the results of these post-marketing programs.
Satisfaction of FDA requirements or similar requirements of
state, local and foreign regulatory agencies typically takes at
least several years and the actual time required may vary
substantially, based upon, among other things, the type,
complexity and novelty of the product or disease. Government
regulation may delay or prevent marketing of potential products
for a considerable period of time and impose costly procedures
upon our activities. Success in early-stage clinical trials does
not assure success in later-stage clinical trials. Data obtained
from clinical activities are not always conclusive and may be
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susceptible to varying interpretations, which could delay, limit
or prevent regulatory approval. Even if a product receives
regulatory approval, the approval may be significantly limited
to specific diseases and dosages. Further, even after regulatory
approval is obtained, later discovery of previously unknown
problems with a product may result in restrictions on the
product or even complete withdrawal of the product from the
market. Delays in obtaining, or failures to obtain regulatory
approvals for any drug candidate could substantially harm
Predixs business and cause its stock price to drop
significantly. In addition, Predix cannot predict what adverse
governmental regulations may arise from future U.S. or
foreign governmental action.
Any drug products manufactured or distributed by Predix pursuant
to FDA approvals are subject to continuing regulation by the
FDA, including, among other things, record-keeping requirements,
reporting of adverse experiences with the drug, drug sampling
and distribution requirements, notifying the FDA and gaining its
approval of certain manufacturing or labeling changes, complying
with certain electronic records and signature requirements and
complying with FDA promotion and advertising requirements. Drug
manufacturers and their subcontractors are required to register
their establishments with the FDA and certain state agencies,
and are subject to periodic unannounced inspections by the FDA
and certain state agencies for compliance with cGMP, which
impose certain procedural and documentation requirements upon
Predix and its contract manufacturers. Predix cannot be certain
that it or its present or future suppliers will be able to
comply with the pharmaceutical cGMP regulations and other FDA
regulatory requirements.
The FDAs policies may change and additional government
regulations may be enacted which could prevent or delay
regulatory approval of Predixs drug candidates. Predix
cannot predict the likelihood, nature or extent of adverse
governmental regulation, which might arise from future
legislative or administrative action, either in the United
States or abroad.
Under the Orphan Drug Act, the FDA may grant orphan drug
designation to drugs intended to treat a rare disease or
condition, which is generally a disease or condition that
affects fewer than 200,000 individuals in the U.S. Orphan
drug designation must be requested before submitting an NDA.
After the FDA grants orphan drug designation, the identity of
the therapeutic agent and its potential orphan use are disclosed
publicly by the FDA. Orphan drug designation does not convey any
advantage in or shorten the duration of the regulatory review
and approval process. If a product that has orphan drug
designation subsequently receives FDA approval for the disease
for which it has such designation, the product is entitled to
orphan product exclusivity, which means that the FDA may not
approve any other applications to market the same drug for the
same indication, except in very limited circumstances, for seven
years. Orphan drug exclusivity, however, also could block the
approval of our product for seven years if a competitor obtains
approval of the same drug as defined by the FDA or if
Predixs product is determined to be contained within the
competitors product for the same indication or disease.
Predix intends to file for orphan drug designation for those
diseases that meet the criteria for orphan designation,
including for PRX-08066 for the treatment of PAH. There is no
guarantee that Predix will be awarded orphan exclusivity for
PRX-08066 or for any other products or indications. In addition,
obtaining FDA approval to market a product with orphan drug
exclusivity may not provide Predix with a material commercial
advantage.
The FDA Modernization Act of 1997 included a pediatric
exclusivity provision that was extended by the Best
Pharmaceuticals for Children Act of 2002. Pediatric exclusivity
is designed to provide an incentive to manufacturers for
conducting research about the safety of their products in
children. Pediatric exclusivity, if granted, provides an
additional six months of market exclusivity in the United States
for new or currently marketed drugs. Under Section 505a of
the Federal Food, Drug and Cosmetic Act, six months of market
exclusivity may be granted in exchange for the voluntary
completion of pediatric studies in accordance with an FDA-issued
Written Request. The FDA may issue a Written Request
for studies on unapproved or approved indications, where it
determines that information relating to the use of a drug in a
pediatric population, or part of the pediatric population, may
produce health benefits in that population. Predix has not
requested or received a Written Request for such pediatric
studies, although Predix may ask the FDA to issue a Written
Request for such studies in the future. To receive the six-month
pediatric
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market exclusivity, Predix would have to receive a Written
Request from the FDA, conduct the requested studies and submit
reports of the studies in accordance with a written agreement
with the FDA or, if there is no written agreement, in accordance
with commonly accepted scientific principles. There is no
guarantee that the FDA will issue a Written Request for such
studies or accept the reports of the studies. The current
pediatric exclusivity provision is scheduled to end on
October 1, 2007 and it may not be reauthorized.
Reimbursement
Sales of biopharmaceutical products depend in significant part
on the availability of third-party reimbursement. Predix intends
to seek reimbursement from third-party payors with respect to
any products that may be approved in the future. It is time
consuming and expensive for Predix to seek reimbursement from
third-party payors. Reimbursement may not be available or
sufficient to allow Predix to sell its products on a competitive
and profitable basis.
The passage of the Medicare Prescription Drug and Modernization
Act of 2003, or the MMA, imposes new requirements for the
distribution and pricing of prescription drugs for Medicare
beneficiaries, which may affect the marketing of Predixs
products. The MMA also introduced a new reimbursement
methodology, part of which went into effect in 2004. At this
point, it is not clear what effect the MMA will have on the
prices paid for currently approved drugs and the pricing options
for new drugs approved after January 1, 2006. Moreover,
while the MMA applies only to drug benefits for Medicare
beneficiaries, private payors often follow Medicare coverage
policy and payment limitations in setting their own payment
rates. Any reduction in payment that results from the MMA may
result in a similar reduction in payments from non-governmental
payors.
In addition, in some foreign countries, the proposed pricing for
a drug must be approved before it may be lawfully marketed. The
requirements governing drug pricing vary widely from country to
country. For example, the European Union provides options for
its member states to restrict the range of medicinal products
for which their national health insurance systems provide
reimbursement and to control the prices of medicinal products
for human use. A member state may approve a specific price for
the medicinal product or it may instead adopt a system of direct
or indirect controls on the profitability of the company placing
the medicinal product on the market.
Predix expects that there will continue to be a number of
federal and state proposals to implement governmental pricing
controls. While Predix cannot predict whether such legislative
or regulatory proposals will be adopted, the adoption of such
proposals could have a material adverse effect on Predixs
business, financial condition and profitability.
Employees
Predix believes that its success will depend greatly on its
ability to identify, attract and retain capable employees. As of
April 18, 2006, Predix had 49 full time employees,
including a total of 31 employees who hold M.D. or Ph.D.
degrees, 42 of our employees are primarily engaged in research
and development activities, and 7 are primarily engaged in
general and administrative activities. Predixs employees
are not represented by any collective bargaining unit.
Properties
Predixs operations are based primarily in Lexington,
Massachusetts. Predix currently leases and occupies the
following properties:
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Approximate | |
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Square Feet | |
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Use | |
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Date | |
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Maguire Road, Lexington, Massachusetts
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27,500 |
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Office & Laboratory |
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October 15, 2012 |
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Hayetzira Street, Ramat Gan, Israel
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6,458 |
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Office & Laboratory |
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October 14, 2006 |
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177
In addition, Predix also leases approximately 25,338 square
feet of space in Princeton, New Jersey under a lease that
expires on July 1, 2011. Predix subleases all of this space
to a single tenant under a sublease that expires on
June 30, 2011.
Legal Proceedings
From time to time in the ordinary course of business, Predix is
subject to various claims, charges and litigation. Currently,
Predix is not a party to any current material legal proceedings.
178
PREDIX MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion of Predixs
financial condition and results of operations in conjunction
with Predixs consolidated financial statements and the
related notes included elsewhere in this joint proxy statement/
prospectus. This discussion contains forward-looking statements
that involve risks and uncertainties. As a result of many
factors, including those set forth under the section entitled
Risk Factors and elsewhere in this joint proxy
statement/ prospectus, Predixs actual results may differ
materially from those anticipated in these forward-looking
statements.
Overview
Predix is a pharmaceutical company focused on the discovery and
development of novel, highly selective, small-molecule drugs
that target G-Protein Coupled Receptors, or GPCRs, and ion
channels. Combined with a focused drug development and
regulatory strategy, Predixs proprietary drug discovery
technology and approach has enabled it to discover, develop, and
advance three drug candidates into clinical trials in the last
three-and-a-half years. Predix is expecting to complete the
first of at least two pivotal Phase III clinical trials for
generalized anxiety disorder, or GAD, for its lead drug
candidate PRX-00023 in the second half of 2006. Predix completed
a Phase IIa clinical trial of PRX-00023 in this indication
in July 2005. Predix has two other clinical-stage drug
candidates that have completed Phase I clinical trials:
PRX-03140 for the treatment of Alzheimers disease that is
expected to enter Phase II trials in the second half of
2006, and PRX-08066 for the treatment of two types of pulmonary
hypertension, or PH, which are PH associated with chronic
obstructive pulmonary disease, or COPD, that is expected to
enter Phase II trials in the second half of 2006, and
pulmonary arterial hypertension, or PAH.
Predix was incorporated in Delaware on November 2, 1994 as
Takhus Pharmaceuticals, Inc. and changed its name in December
1996 to Physiome Sciences, Inc. Prior to 2003, Predix was
focused on the development and commercialization of software and
databases used to support the discovery and development of new
drugs. In late 2002, Predixs board of directors decided to
change the business focus of the company and began actively
pursuing the sale or merger of the company to or with a company
engaged in drug discovery. In August 2003, Predix acquired all
of the capital stock of Predix Pharmaceuticals Ltd., an Israeli
corporation, and changed Predixs name to Predix
Pharmaceuticals Holdings, Inc. Subsequent to Predixs
acquisition of Predix Pharmaceuticals Ltd., Predix changed
Predixs business focus to drug discovery and development
focusing on GPCRs and ion channels, using Predixs
software, together with the proprietary technology Predix
acquired. The acquisition was accounted for under the purchase
method of accounting. The purchase price of $7.7 million
was funded with Predixs capital stock. The purchase price
was allocated to the net tangible assets acquired
($1.0 million), with the significant majority of the
purchase price ($6.7 million) being allocated to in-process
research and development intangibles, which were charged to
operating expenses at the acquisition date. Since Predix
Pharmaceuticals Ltd. was a development stage enterprise at the
time of the acquisition, no goodwill was recorded. As a result
of the acquisition of Predix Pharmaceuticals Ltd. and the shift
in Predixs business focus, Predix consolidated facilities
and reduced headcount which resulted in a restructuring charge
in 2003 of $5.4 million.
Predix has never been profitable and, as of December 31,
2005, Predix had an accumulated deficit of $121.4 million.
Predix had net losses of $33.7 million for the year ended
December 31, 2005, $19.4 million for the year ended
December 31, 2004, $24.6 million for the year ended
December 31, 2003. Prior to Predixs shift in business
focus, Predix generated revenue from software licensing. Predix
no longer sells or licenses software. However, the software is
used internally in Predixs ion channel discovery programs.
Predix has funded Predixs operations primarily through
private placements of equity securities. From inception through
December 31, 2005, Predix has raised net proceeds of
$112.4 million from private equity financings, including
$43.0 million in net proceeds from the sale of
Predixs Series C convertible preferred stock in late
2004 and early 2005. In late March and early April 2006, Predix
received $9.5 million in proceeds from a convertible bridge
financing. The loan amount is payable upon closing of the merger
or becomes convertible into Predix stock within one year if the
merger is not consummated. Predix expects to
179
incur significant and increasing operating losses for at least
the foreseeable future as Predix advances Predixs drug
candidates from discovery through pre-clinical and clinical
trials and seek regulatory approval and eventual
commercialization. In addition to these increasing research and
development expenses, Predix expects general and administrative
costs to increase significantly as Predix adds personnel.
Predixs future success will be dependent on the successful
development and commercialization of Predixs drug
candidates, including PRX-00023, PRX-03140 and PRX-08066. To
date, Predix has not generated any revenue from the sale of any
pharmaceutical product. Predix does not have the required
regulatory approvals to market any of Predixs drug
candidates, and Predix may never receive them. Predixs
business is subject to significant risks, including but not
limited to the risks inherent in Predixs ongoing clinical
trials and the regulatory approval process, the results of
Predixs research and development efforts, competition from
other products and technologies and uncertainties associated
with obtaining and enforcing patent rights. Predix may not be
profitable even if Predix succeeds in commercializing any of
Predixs drug candidates.
Discovery Alliance
In March 2005, Predix entered into a research, development and
commercialization agreement with Cystic Fibrosis Foundation
Therapeutics Incorporated, or CFFT, the drug discovery and
development affiliate of the Cystic Fibrosis Foundation. In
connection with this agreement, Predix received an upfront
payment of $2.0 million and may be entitled to receive
additional funding in the form of research funding and milestone
payments. The agreement covers two research programs, one of
which has a term of two years and the second of which has a term
of three years. CFFT may terminate either or both programs
without cause upon 120 days notice.
Predix is recognizing the $2.0 million upfront payment as
revenue ratably over the three-year term. The reimbursements of
research and development costs are being recognized as revenue
as the related costs are incurred. As Predix is the party
responsible for providing the research services, Predix is
recognizing the reimbursements of the costs associated with
Predixs research efforts as revenue, not as a net research
expense. Predix will recognize any milestone payments as revenue
when the related performance obligation, as defined in the
agreement, is achieved.
Critical Accounting Policies
The discussion and analysis of Predixs financial condition
and results of operations are based on Predixs
consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the
United States. The preparation of these financial statements
requires Predix to make estimates and judgments that affect the
reported amounts of assets, liabilities, revenue and expenses.
On an ongoing basis, Predix evaluates Predixs estimates
and judgments, including those related to revenue recognition,
accrued expenses, research and development and the fair
valuation of stock related to stock-based compensation. Predix
bases Predixs estimates on historical experience and on
various other assumptions that Predix believes to be reasonable
under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and
liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different
assumptions or conditions.
While Predixs significant accounting policies are more
fully described in note 2 to Predixs consolidated
financial statements included in this prospectus, Predix
believes the following accounting policies are critical to
understanding and evaluating Predixs reported financial
results.
Predix recognizes revenue relating to collaborations in
accordance with the Securities and Exchange Commissions
Staff Accounting Bulletin (SAB) No. 104, Revenue
Recognition in Financial Statements (SAB 104). Revenue
under collaborations may include the receipt of non-refundable
license fees, milestone payments and research and development
payments.
180
Predix recognizes nonrefundable upfront license fees and
guaranteed, time-based payments that require continuing
involvement in the form of research and development as revenue:
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ratably over the development period if development risk is
significant; or |
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based upon the level of research services performed during the
period of the research contract. |
When the period of deferral cannot be specifically identified
from the contract, management estimates the period based upon
other critical factors contained within the contract. Predix
continually reviews such estimates which could result in a
change in the deferral period and might impact the timing and
amount of revenue recognized.
In accordance with Predixs policy, Predix is recognizing
revenue from the $2.0 million upfront payment from CFFT
over the development period, the three-year term of the
agreement.
Milestone payments are recognized as revenue when the
performance obligations, as defined in the contract, are
achieved. Performance obligations typically consist of
significant milestones in the development life cycle of the
related technology, such as initiation of clinical trials,
filing for approval with regulatory agencies and approvals by
regulatory agencies.
Royalties are recognized as revenue when earned.
Reimbursements of research and development costs are recognized
as revenue as the related costs are incurred.
Prior to 2003, Predixs business focused on developing and
licensing software and databases used to support the discovery
and development of new drugs. Predixs business is now
focused on the discovery and development of GPCR and ion
channel-targeted drugs, using Predixs software together
with the proprietary technology Predix acquired from Predix
Pharmaceuticals Ltd., which was never licensed externally.
Predix no longer licenses or sells software. The revenue
generated from the licensing of this software was recognized in
accordance with the American Institute of Certified Public
Accountants Statement of Position (SOP) 97-2, Software
Revenue Recognition
(SOP 97-2), as
amended by SOP 98-9, Software Revenue Recognition, with
Respect to Certain Arrangements (SOP 98-9). The
products and services underlying these arrangements were
considered elements in a multiple-element arrangement. Revenue
under such multiple-element arrangements were allocated to each
element based on the residual method.
Under the residual method, the fair value of the undelivered
elements is deferred and subsequently recognized when earned.
Predix had established sufficient vendor-specific objective
evidence of fair value for the undelivered elements.
Accordingly, systems revenue was recognized under the residual
method in arrangements in which a system was sold.
As part of the process of preparing financial statements, Predix
is required to estimate accrued expenses. This process involves
identifying services that have been performed on Predixs
behalf and estimating the level of service to be performed and
the associated cost incurred for such service where Predix has
not been invoiced or otherwise notified of actual costs. This is
done as of each balance sheet date in Predixs consolidated
financial statements. Examples of estimated accrued expenses
include:
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professional service fees; |
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contract clinical service fees; |
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fees paid to data management organizations and investigators in
conjunction with clinical trials; and |
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fees paid to contract manufacturers in conjunction with the
production of clinical materials. |
181
In connection with such service fees, Predixs estimates
are most affected by Predixs projections of the timing of
services provided relative to the actual level of services
incurred by such service providers. The majority of
Predixs service providers invoice Predix in arrears for
services performed. In the event that Predix does not identify
certain costs that have begun to be incurred or Predix under or
over estimates the level of services performed or the costs of
such services, Predixs actual expenses could differ from
such estimates. The date on which certain services commence, the
level of services performed on or before a given date, and the
cost of such services are often subjective determinations.
Predix makes these judgments based upon the facts and
circumstances known to Predix at the time of accrual in
accordance with accounting principles generally accepted in the
United States. To date, Predix has not had material changes in
estimates.
Research and development expenses include the costs associated
with Predixs internal research and development activities,
including salaries and benefits, occupancy costs and research
and development conducted for Predix by third parties, such as
sponsored university-based research and contract research
organizations. In addition, research and development expenses
include the cost of clinical trial drug supply shipped to
Predixs contract research organizations. Predix accounts
for Predixs clinical trial costs by estimating the total
cost to treat a patient in each clinical trial and recognizing
this cost as and when the patient receives treatment, beginning
when the patient enrolls in the trial. This estimated cost
includes payments to the trial site and patient-related costs,
including laboratory costs related to the conduct of the trial.
Cost per patient varies based on the type of clinical trial, the
site of the clinical trial and the length of the treatment
period for each patient. As actual costs become known to us,
Predix adjusts Predixs accrual; such changes in estimate
may be a material change in Predixs clinical study
accrual, which could also materially affect Predixs
results of operations.
Predix has elected to follow Accounting Principles Board
(APB) Opinion No. 25, Accounting for Stock Issued
to Employees (APB 25), and related interpretations, in
accounting for Predixs stock-based employee compensation
plans, rather than the alternative fair value accounting method
provided for under the Financial Accounting Standards Board
(FASB) Statement of Financial Accounting Standards
(SFAS) No. 123, Accounting for Stock-Based
Compensation (SFAS 123). In the notes to Predixs
consolidated financial statements, Predix provides pro forma
disclosures in accordance with SFAS 123 and related
pronouncements. Predix accounts for stock options and warrants
granted to non-employees based on the fair value of the stock
option or warrant. The factor which most affects the accounting
for stock-based compensation is the fair value of Predixs
common stock at the measurement date. Predixs common stock
has not been publicly traded. As a result, in valuing
Predixs common stock, stock options and warrants Predix
considers the pricing of private equity sales, company specific
events, economic trends and the rights and preferences of the
security being valued.
Accounting for equity instruments granted or sold by Predix
under APB Opinion No. 25, SFAS No. 123 and EITF
Issue No. 96-18 requires fair value estimates of the equity
instrument granted or sold. Predix estimated the fair value of
the equity instruments for accounting purposes based upon
consideration of factors which Predix deemed to be relevant at
the time. Because shares of Predixs common stock have not
been publicly traded, market factors historically considered in
valuing stock and stock option grants include comparative values
of public companies discounted for the risk and limited
liquidity provided for in the shares Predix is issuing, pricing
of private sales of Predixs convertible preferred stock,
prior valuations of stock grants and the effect of events that
have occurred between the time of such grants, economic trends
and the comparative rights and preferences of the security being
granted compared to the rights and preferences of Predixs
other outstanding equity.
The fair value of Predixs common stock for accounting
purposes is determined by Predixs board of directors. In
making that determination, the board of directors draws on the
knowledge of its directors who have experience in early-stage
life sciences companies and with other life science industry
companies.
182
Financial Operations Overview
Predix does not currently have any commercial products for sale
and do not anticipate having any commercial products for sale
for at least the next several years, if at all. To date,
Predixs revenue has been derived solely from licensing of
software (prior to 2004) and from Predixs collaboration
with CFFT entered into in March 2005. Under Predixs
collaboration with CFFT, Predix received an upfront payment of
$2.0 million. The upfront payment received from CFFT is
being recognized as revenue ratably over Predixs period of
involvement, which is the three-year term of the agreement, with
the unrecognized balance being deferred. Under the agreement
Predix is entitled to continued cost reimbursements and research
funding and may earn milestone payments in accordance with the
terms of the agreement. Any additional revenue that Predix may
receive in the future is expected to consist primarily of
milestone payments and payments for reimbursements of research
and development costs. The reimbursements of research and
development costs are being recognized as revenue as the related
costs are incurred. As Predix is the party responsible for
providing the research services, Predix is recognizing the
reimbursements of the costs associated with Predixs
research efforts as revenue, not as a net research expense.
Predix will recognize any milestone payments as revenue when the
related performance obligation, as defined in the agreement, is
achieved.
Predix is no longer engaged in the business of selling software.
Predix does not anticipate earning any significant additional
software sales revenue.
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Research and Development Expense |
Research and development expense consists primarily of:
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salaries, benefits and related expenses for personnel engaged in
research and development activities; |
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fees paid to contract research organizations to manage and
monitor clinical trials; |
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fees paid to research organizations in conjunction with
pre-clinical studies; |
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fees paid to access chemical and intellectual property databases; |
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costs of materials used in research and development and clinical
studies; |
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academic testing and consulting, license and sponsored research
fees paid to third parties; and |
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costs of facilities and equipment, including depreciation, used
in research and development activities. |
Predix expenses both internal and external research and
development costs as incurred. Predix expects Predixs
research and development expense to increase significantly as
Predix continues to expand Predixs pipeline of drug
candidates and to advance Predixs existing drug candidates
through the clinical trial process. Predix expects that a large
percentage of Predixs research and development expenses in
the future will be incurred in support of Predixs current
and future pre-clinical and clinical development programs. These
expenditures are subject to numerous uncertainties in timing and
cost to completion. Predix tests drug candidates in pre-clinical
studies for safety, toxicology and efficacy. Predix then
conducts early-stage clinical trials for each drug candidate. As
Predix obtains results from trials, Predix may elect to
discontinue or delay clinical trials for certain drug candidates
in order to focus Predixs resources on more promising drug
candidates.
183
Predix currently has three drug candidates in clinical
development. The following summarizes the applicable disease
indication and the clinical status of these three drug
candidates:
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Drug |
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Candidate |
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Disease Indication |
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Clinical Trial Status | |
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PRX-00023
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Generalized anxiety disorder |
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Phase III ongoing |
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PRX-03140
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Alzheimers disease |
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Completed Phase I |
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PRX-08066
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Pulmonary hypertension |
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Completed Phase I |
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Completion of clinical trials may take several years or more,
but the length of time can vary substantially according to a
number of factors, including the type, complexity, novelty and
intended use of a drug candidate. The cost of clinical trials,
and therefore the amount and timing of Predixs capital
requirements, may vary significantly over the life of a project
as a result of differences arising during clinical development,
including, among others:
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the number of sites included in the trials; |
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the length of time required to enroll suitable patient subjects; |
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the number of patients that participate in the trials; |
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the duration of patient
follow-up that seems
appropriate in view of results; and |
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the efficacy and safety profile of the drug candidate. |
Predix could incur increased clinical development costs if
Predix experiences delays in clinical trial enrollment, delays
in the evaluation of clinical trial results or delays in
regulatory approvals. In addition, Predix faces significant
uncertainty with respect to Predixs ability to enter into
strategic collaborations with respect to Predixs drug
candidates. As a result of these factors, it is difficult to
estimate the cost and length of a clinical trial. Predix is
unable to accurately and meaningfully estimate the cost to bring
a product to market due to the variability in length of time to
develop and obtain regulatory approval for a drug candidate.
Predix estimates that clinical trials in Predixs areas of
focus are typically completed over the following timelines, but
delays can occur for many reasons including those set forth
above:
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Clinical |
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Estimate | |
Phase |
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Objective |
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Completion Period | |
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Phase I
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Establish safety in healthy volunteers and occasionally in
patients; study how the drug works, is metabolized and interacts
with other drugs |
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1-2 years |
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Phase II
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Evaluate efficacy, optimal dosages and expanded evidence of
safety |
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2-3 years |
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Phase III
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Further evaluate efficacy and safety of the drug candidate in a
larger patient population |
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2-3 years |
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If Predix successfully completes Phase III clinical trials
of a drug candidate, Predix intends to submit the results of all
of the clinical trials for such drug candidate to the FDA to
support regulatory approval. Even if any of Predixs drug
candidates receive regulatory approval, Predix may still be
required to perform lengthy and costly post-marketing studies.
A major risk associated with the timely completion and
commercialization of Predixs drug candidates is the
ability to confirm safety and efficacy based on the data of
long-term clinical trials. Predix cannot be certain that any of
Predixs drug candidates will prove to be safe or
effective, will receive regulatory approvals or will be
successfully commercialized. In order to achieve marketing
approval, the FDA or foreign regulatory agencies must conclude
that Predixs clinical data establishes the safety and
efficacy of Predixs drug candidates. If Predixs
clinical-stage drug candidates are not successfully developed,
future results of operations may be adversely affected.
Predix does not budget or manage Predixs research and
development costs by project on a fully allocated basis.
Consequently, fully loaded research and development costs by
project are not available.
184
Predix uses Predixs employee and infrastructure resources
across several projects, and many of Predixs costs are not
attributable to an individually-named project but are directed
to broadly applicable research projects. As a result, Predix
cannot state precisely the costs incurred for each of
Predixs clinical and pre-clinical projects on a
project-by-project basis. Predix estimates that, from inception
through December 31, 2005, the total
out-of-pocket payments
made by Predix to third parties for pre-clinical study support,
clinical supplies and clinical trials associated with PRX-00023,
PRX-03140 and PRX-08066 are as follows:
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Inception | |
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Year Ended December 31, | |
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Through | |
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December 31, | |
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2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
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| |
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| |
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(In thousands) | |
PRX-00023
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$ |
2,340 |
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$ |
4,584 |
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$ |
5,917 |
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$ |
12,841 |
|
PRX-03140
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1,846 |
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4,102 |
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5,948 |
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PRX-08066
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709 |
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6,268 |
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6,977 |
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$ |
2,340 |
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$ |
7,139 |
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$ |
16,287 |
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$ |
25,766 |
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Predix recorded a one-time, non-cash charge in 2003 of
$6.6 million for acquired in-process research and
development, or IPR&D. The valuation of acquired IPR&D
represents the estimated fair value related to incomplete
projects that, at the time of Predixs acquisition of
Predix Pharmaceuticals Ltd., had no alternative future use.
The $6.7 million in-process technology Predix acquired from
Predix Pharmaceuticals Ltd. consisted of three research and
development projects, acquired technology and a portfolio of
pending patent applications. The research and development
projects included a pre-clinical early development drug
candidate for the treatment of GAD and depression (PRX-00023),
and two lead optimization compounds, targeting Alzheimers
disease (PRX-03140) and chemotherapy induced emesis (i.e.,
vomiting), respectively. The early development candidate
(PRX-00023) is now in Phase III clinical trials for GAD.
The Alzheimers disease lead optimization compound
(PRX-03140) is expected to enter Phase IIa clinical trials
and the third research program was terminated.
The technology acquired consisted in large part of
computer-based models of biological receptors and methods of
designing drugs to bind to those receptors. Predix
Pharmaceuticals Ltd. licensed this technology from Ramot at Tel
Aviv University Ltd., the technology transfer company of Tel
Aviv University. At the time of acquisition this technology was
novel and unproven. This acquired technology, after further
development, is now in part embodied in Predixs
proprietary drug discovery technology and approach.
As a result of the uncertainties discussed above, Predix is
unable to determine the duration and completion costs of
Predixs research and development projects or when and to
what extent Predix will receive cash inflows from the
commercialization and sale of a product.
Predix expects Predixs research and development expense to
increase significantly for the foreseeable future as Predix
advances Predixs drug candidates from discovery through
pre-clinical and clinical trials and seek regulatory approval
and eventual commercialization.
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General and Administrative Expense |
General and administrative expense consists primarily of
salaries and other related costs for personnel serving
executive, business development, finance and administrative
functions. Other costs include facility costs not included in
research and development expense, insurance, professional fees
for legal, accounting and information technology services.
Predix expects Predixs general and administrative expense
to increase significantly as Predix hires new personnel and
incur additional public company expenses relating to investor
relations, reporting and other obligations.
185
Investment income, net consists of interest earned on
Predixs cash and cash equivalents offset by investment
expenses.
Interest expense consists of interest incurred on equipment
leases.
Results of Operations
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|
Years Ended December 31, 2005 and 2004 |
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Year Ended December 31, | |
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Percentage | |
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2005 | |
|
2004 | |
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Change | |
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| |
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| |
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(In thousands) | |
Revenue
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$ |
2,300 |
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$ |
13 |
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17,592 |
% |
Costs and expenses:
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Research and development
|
|
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29,351 |
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|
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16,427 |
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|
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79 |
% |
General and administrative
|
|
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7,031 |
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|
|
3,011 |
|
|
|
134 |
% |
Restructuring
|
|
|
205 |
|
|
|
77 |
|
|
|
166 |
% |
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
36,587 |
|
|
|
19,515 |
|
|
|
87 |
% |
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(34,287 |
) |
|
|
(19,502 |
) |
|
|
76 |
% |
Investment income, net
|
|
|
614 |
|
|
|
147 |
|
|
|
318 |
% |
Interest expense
|
|
|
(30 |
) |
|
|
(37 |
) |
|
|
(19 |
%) |
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(33,703 |
) |
|
$ |
(19,392 |
) |
|
|
74 |
% |
|
|
|
|
|
|
|
|
|
|
Revenue was $2.3 million for the year ended
December 31, 2005 compared to $13,000 for the year ended
December 31, 2004, an increase of 17,592%. Revenue in the
2004 period relates to a 2003 software license of $13,000. The
revenue in the 2005 period primarily relates to reimbursed
research costs and the amortized portion of the upfront payment
from Predixs collaboration with CFFT. In connection with
the execution of the CFFT agreement in March 2005 Predix
received an upfront payment of $2.0 million. Predix is
recognizing this upfront payment as revenue ratably over the
three year contract term. The revenue recognized during the
twelve months ended December 31, 2005, primarily relates to
the upfront payment amortization of $556,000 and reimbursed
research services and costs of $1,737,000. Also included in the
2005 revenue is $7,000 from a software license.
|
|
|
Research and Development Expense |
Research and development expense was $29.4 million for the
year ended December 31, 2005 compared to $16.4 million
for the year ended December 31, 2004, an increase of 79%.
The increase is primarily attributable to the increased
pre-clinical and clinical development costs of
$10.2 million associated with an increase in the number of
drug candidates Predix has in the clinic, including increased
pre-clinical, clinical, manufacturing and personnel costs.
Predix initiated a Phase I clinical trial for PRX-00023 in
February 2004. During the year ended December 31, 2005,
Predix had three drug candidates in the clinic (PRX-00023,
PRX-03140 and PRX-08066). The increase in costs from period to
period relates to an increase in expenses associated with the
establishment and maintenance of these additional clinical
trials. In addition, salaries and benefits for research and
development personnel increased by $1.7 million as
headcount increased to support the additional drug candidates.
Predix expects Predixs research and development expense to
increase significantly for the foreseeable future as Predix
advances Predixs drug
186
candidates from discovery through pre-clinical and clinical
trials and seek regulatory approval and eventual
commercialization.
|
|
|
General and Administrative Expense |
General and administrative expense was $7.0 million for the
year ended December 31, 2005 compared to $3.0 million
for the year ended December 31, 2004, an increase of 134%.
The increase is primarily attributable to increased professional
service costs for legal, accounting, public relations,
recruiting, and recruiting as well as an increase in salaries
and benefits. During 2005, Predix filed for an Initial Public
Offering which was subsequently withdrawn in October 2005. In
connection with this, Predix incurred $1.4 million in
professional services. Legal and accounting costs not associated
with the attempted offering increased by $0.9 million,
while public relations costs increased by $0.3 million and
salaries and benefits increased by $0.6 million. In
addition, other administrative costs, including insurance
premiums and administrative office expenses associated with
business growth have also increased. Predix expects
Predixs general and administrative expense to increase
significantly as Predix hires new personnel to support the
growth of Predixs operations.
As a result of Predixs acquisition of Predix
Pharmaceuticals Ltd. and the shift in Predixs business
focus, Predix consolidated facilities and reduced headcount
which resulted in a restructuring charge in 2003 of
$5.4 million. The restructuring charges for the years ended
December 31, 2005 and 2004 relate to the adjusting of the
2003 restructuring estimates to actual costs.
Investment income, net was $614,000 for the year ended
December 31, 2005 compared to $147,000 for the year ended
December 31, 2004, an increase of 318%. The increase is
primarily attributable to a significant increase in interest
income due to an increase in the average balance of cash
invested during 2005 as compared to 2004. From September 2004
through January 2005, Predix raised net cash proceeds of
approximately $43.0 million through the private placement
of equity. Interest rate changes were not a significant
component of the interest income increase.
Interest expense was $30,000 for the year ended
December 31, 2005 compared to $37,000 for the year ended
December 31, 2004, a decrease of 19%. The decrease is
primarily attributable to a decrease in the average debt balance
from period to period.
187
|
|
|
Years Ended December 31, 2004 and 2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
|
|
| |
|
Percentage | |
|
|
2004 | |
|
2003 | |
|
Change | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Revenue
|
|
$ |
13 |
|
|
$ |
1,068 |
|
|
|
(99 |
)% |
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
16,427 |
|
|
|
14,632 |
|
|
|
12 |
|
General and administrative
|
|
|
3,011 |
|
|
|
5,782 |
|
|
|
(48 |
) |
Restructuring
|
|
|
77 |
|
|
|
5,350 |
|
|
|
(99 |
) |
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
19,515 |
|
|
|
25,764 |
|
|
|
(24 |
) |
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(19,502 |
) |
|
|
(24,696 |
) |
|
|
(21 |
) |
Investment income, net
|
|
|
147 |
|
|
|
142 |
|
|
|
4 |
|
Interest expense
|
|
|
(37 |
) |
|
|
(6 |
) |
|
|
517 |
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(19,392 |
) |
|
$ |
(24,560 |
) |
|
|
(21 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in Predixs Business Focus |
Prior to 2003, Predixs business focused on the development
and commercialization of software and databases used to support
the discovery and development of new drugs. After the August
2003 acquisition of Predix Pharmaceuticals Ltd., Predix changed
Predixs business focus and began using Predixs
software, together with the proprietary technology Predix
acquired, to focus on the discovery and development of GPCR and
ion channel-targeted drugs.
Revenue was $13,000 for the year ended December 31, 2004
compared to $1.1 million for the year ended
December 31, 2003, a decrease of 99%. Revenue in both
periods relates to software licensing. The significant decrease
in revenue is due to Predixs change in business focus.
Prior to 2004 Predix generated revenue from licensing software.
Beginning in 2003, Predixs business focus changed from
software licensing to primarily engaging in drug discovery and
development. Under Predixs current business model, Predix
no longer sells or licenses software. The 2004 revenue relates
to a 2003 software license.
|
|
|
Research and Development Expense |
Research and development expense was $16.4 million for the
year ended December 31, 2004 compared to $14.6 million
for the year ended December 31, 2003, an increase of 12%.
The increase is primarily attributable to Predixs change
in business focus in 2003, which resulted in pre-clinical and
clinical trial costs of $5.0 million in 2004, which were
not incurred in prior years. Predix initiated a Phase I
clinical trial for PRX-00023 in February 2004, which resulted in
increased costs of $3.3 million relating to the manufacture
of PRX-00023 for the clinical trial as well as significant costs
to establish and manage the trial sites. This increase was
partially offset by decreased personnel and facilities costs as
the full impact of the 2003 restructuring was realized in 2004.
|
|
|
General and Administrative Expense |
General and administrative expense was $3.0 million for the
year ended December 31, 2004 compared to $5.8 million
for the year ended December 31, 2003, a decrease of 48%.
The decrease is primarily attributable to the cost savings
realized from Predixs 2003 restructuring and a decrease in
professional fees from $1.6 million in 2003 to $682,000 in
2004. As a result of Predixs 2003 restructuring,
facilities costs including rent and depreciation on property and
equipment decreased significantly in 2004 to $554,000 as
compared to $2.6 million for 2003. In addition, Predix
incurred significant professional fees of $1.0 million
188
in 2003 related to the acquisition. Also included in 2003 was a
$664,000 non-cash compensation charge related to forgiveness of
a promissory note associated with a stock transaction.
As a result of the acquisition of Predix Pharmaceuticals Ltd.
and the shift in Predixs business focus, Predix
consolidated facilities and reduced headcount which resulted in
restructuring charges of approximately $5.4 million in 2003
and $77,000 in 2004. Included in the 2003 restructuring charge
was $1.5 million for the future lease rental expense, net
of sublease income, related to Predixs former Princeton,
New Jersey office, $2.1 million relating to the write off
of certain property and equipment and $1.8 million related
to severance paid in 2003 for 57 terminated employees.
Investment income, net was $147,000 for the year ended
December 31, 2004 compared to $142,000 for the year ended
December 31, 2003, an increase of 4%. The increase is
primarily attributable to an increase in the average balance of
cash and investments invested during 2004 as compared to 2003.
Interest rate changes were not a significant component of the
interest income increase.
Interest expense was $37,000 for the year ended
December 31, 2004 compared to $6,000 for the year ended
December 31, 2003, an increase of 517%. The increase is
primarily attributable to increased interest expense on
equipment leases. Predix entered into two new lease agreements
in 2004, one in the second quarter and one in the fourth quarter.
|
|
|
Years Ended December 31, 2003 and 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
|
|
| |
|
Percentage | |
|
|
2003 | |
|
2002 | |
|
Change | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Revenue
|
|
$ |
1,068 |
|
|
$ |
551 |
|
|
|
94 |
% |
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
14,632 |
|
|
|
8,534 |
|
|
|
71 |
|
General and administrative
|
|
|
5,782 |
|
|
|
3,223 |
|
|
|
79 |
|
Restructuring
|
|
|
5,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
25,764 |
|
|
|
11,757 |
|
|
|
119 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(24,696 |
) |
|
|
(11,206 |
) |
|
|
120 |
|
Investment income, net
|
|
|
142 |
|
|
|
591 |
|
|
|
(76 |
) |
Interest expense
|
|
|
(6 |
) |
|
|
(5 |
) |
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
Loss on sale of equipment, and related contract
|
|
|
|
|
|
|
(879 |
) |
|
|
(100 |
) |
Net loss before income tax benefit
|
|
|
(24,560 |
) |
|
|
(11,499 |
) |
|
|
114 |
|
Income tax benefit
|
|
|
|
|
|
|
258 |
|
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(24,560 |
) |
|
$ |
(11,241 |
) |
|
|
118 |
% |
|
|
|
|
|
|
|
|
|
|
During 2002, Predix began evaluating the strategic direction of
the company and determined that Predix should apply
Predixs technology and capabilities more directly toward
drug discovery. Accordingly, at that time, Predix began pursuing
a sale, merger or other business combination transaction to or
with a suitable company engaged in drug discovery. Predix
completed such a transaction in August 2003 with Predixs
acquisition of all of the capital stock of Predix
Pharmaceuticals Ltd.
189
Revenue was $1.1 million for the year ended
December 31, 2003 compared to $551,000 for the year ended
December 31, 2002, an increase of 94%. Revenue in both
periods relates to outlicensing of Predixs software and
services. The significant increase in revenue is due to an
increase in the number of software licenses.
|
|
|
Research and Development Expense |
Research and development expense was $14.6 million for the
year ended December 31, 2003 compared to $8.5 million
for the year ended December 31, 2002, an increase of 71%.
The increase is primarily attributable to the shift in focus to
drug discovery in 2003. As a result, Predix began incurring
significant costs in 2003 of approximately $3.1 million for
pre-clinical research and development outsourcing, manufacturing
and the purchase of lab supplies and chemicals. In addition,
Predix incurred approximately $2.4 million in 2003 related
to outsourced research costs. During 2002, research and
development expenses primarily consisted of personnel costs,
outsourcing costs, facilities costs and depreciation expense.
|
|
|
General and Administrative Expense |
General and administrative expense was $5.8 million for the
year ended December 31, 2003 compared to $3.2 million
for the year ended December 31, 2002, an increase of 79%.
The increase is primarily attributable to increased professional
fees and personnel costs. During 2003, Predix incurred
significant professional fees of approximately $1.0 million
relating to Predixs acquisition which resulted in a
significant increase in legal and accounting fees in 2003 as
compared to 2002. Also included in 2003 was a $664,000 one time,
non-cash compensation charge relating to stock option
transactions.
Investment income, net was $142,000 for the year ended
December 31, 2003 compared to $591,000 for the year ended
December 31, 2002, a decrease of 76%. The decrease is
primarily due to decreased interest income resulting from a
significant decrease in the average cash balance on hand due to
losses from operations. Interest rate changes were not a
significant component of the interest income increase.
Interest expense was $6,000 for the year ended December 31,
2003 compared to $5,000 for the year ended December 31,
2002, an increase of 20%. The increase is primarily due to
increased interest expense on equipment leases as Predix entered
into two new leases in 2003.
|
|
|
Loss on Sale of Equipment and Related Contract |
During 2002, Predix recorded a loss on sale of equipment and
related contract of $879,000. This amount represents the loss
recognized from the sale of certain computer equipment during
the period.
During 2002, Predix sold some of Predixs State of New
Jersey net operating loss carryforwards and research and
experimentation credit carryforwards. The proceeds received on
this sale of $258,000 were recorded as an income tax benefit for
the year ended December 31, 2002.
Liquidity and Capital Resources
Predix has financed Predixs operations since inception
through private placements of equity securities, proceeds from
software sales and related services, payments received under
Predixs collaboration with CFFT, proceeds from equipment
financing and capital leases and interest income. From inception
through December 31, 2005, Predix has raised net proceeds
of $112.4 million from private equity financings. From
190
inception through December 31, 2005, Predix has received
$2.0 million in license fees and research funding and
$1.6 million in proceeds from software sales and related
services. To date, inflation has not had a material effect on
Predixs business.
As of December 31, 2005, cash and cash equivalents were
$7.4 million compared to $13.8 million as of
December 31, 2004. The $6.4 million decrease from 2004
to 2005 is due primarily to the significant increase in
operations. The decrease in cash and cash equivalents is
primarily due to the increased costs associated with having
three drug candidates in the clinic in 2005 versus one in 2004.
Cash used in operations increased from $18.9 million in
2004 to $27.1 million in 2005. In 2004, investing
activities provided $3.6 million in cash versus
$2.4 million being used in 2005. The difference is
primarily due to a decrease in proceeds from the sale of
investments. Cash provided by financing activities in 2005 was
$21.7 million versus $21.8 million in 2004. In 2005
and 2004 Predix received $21.6 million and
$21.9 million in net proceeds from the sales of preferred
stock and warrants and $2.0 million and $3.7 million
of proceeds from the sale of Predixs short-term
investments, respectively. Net cash used in operations increased
from $10.5 million for the year ended December 31,
2003 to $18.9 million for the year ended December 31,
2004, due to the funding of Predixs net loss. Net cash
provided by investing activities decreased from
$8.8 million for the year ended December 31, 2003 to
$3.6 million for the year ended December 31, 2004,
primarily due to a decrease in proceeds from the sales of
investments. Net cash provided by financing activities increased
significantly from $0.9 million for the year ended
December 31, 2003 to $21.8 million in the year ended
December 31, 2004, due to the $21.9 million in net
proceeds from Predixs sale of Series C convertible
preferred stock in the fourth quarter of 2004. Predixs
cash and cash equivalents are highly liquid investments with a
maturity of three months or less at date of purchase and consist
of time deposits and investments in money market funds with
commercial banks and financial institutions.
In January 2005, Predix completed a private equity funding round
raising a total of $43.0 million and issuing
196,431,820 shares of Predixs Series C
convertible preferred stock. Of the $43.0 million raised in
this funding, $21.9 million was received during 2004 and
the remaining $21.1 million was received in 2005. In March
2005, Predix entered into a three year research, development and
commercialization agreement with CFFT. Under this agreement,
Predix received an upfront payment of $2.0 million and can
receive additional license fees, cost reimbursements and
milestone payments. At December 31, 2005, cash and cash
equivalents were $7.4 million.
Predixs contractual obligations relate to rent on
facilities leases for Predixs Lexington, Massachusetts
facility, Ramat Gan, Israel facility and the property abandoned
in Princeton, New Jersey, equipment notes and capital leases on
office equipment. The following table summarizes as of
December 31, 2005, Predixs contractual obligations
for equipment notes, operating and capital lease payments for
office and laboratory equipment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due in | |
|
|
| |
|
|
2006 | |
|
2007 | |
|
2008 | |
|
2009 | |
|
2010 | |
|
Thereafter | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Operating leases
|
|
$ |
1,398 |
|
|
$ |
1,497 |
|
|
$ |
1,602 |
|
|
$ |
1,602 |
|
|
$ |
1,627 |
|
|
$ |
1,707 |
|
Capital leases
|
|
|
105 |
|
|
|
51 |
|
|
|
38 |
|
|
|
32 |
|
|
|
7 |
|
|
|
|
|
Predix expects to continue to incur losses from operations for
at least the next several years. In particular, as described
above, Predix expects to incur increasing research and
development expenses and general and administrative expenses in
the future.
Predixs existing cash and cash equivalents are not
sufficient to enable Predix to fund Predixs operating
expenses, obligations under Predixs equipment debt
financing and capital expenditure requirements beyond July 2006.
On March 31, 2006, Predix entered into a bridge financing
agreement
191
with certain of its shareholders. In connection with this
financing, Predix issued notes totaling $9.5 million. The
notes bear interest at 10% and are payable in one year. In
connection with these notes, Predix issued 200,390 warrants to
the note holders on a pro rata basis. If the merger closes
before August 1, 2006, the warrants convert to
250,000 shares of EPIX common stock on a pro rata basis and
the principal and accrued interest become payable one month from
the closing date of the merger. In the event the merger does not
close, the interest payable upon the notes increases from 10% to
15% and the notes become convertible into Predix stock and
Predix must issue additional warrants to the note holders to
increase the amount of warrants issued to such shareholders to
equal 20% of the respective amounts owed under the notes. The
cash received from this debt financing will enable Predix to
continuing operating through July 31, 2006. In the event
the proposed acquisition by EPIX Pharmaceuticals, Inc. does not
close before this time or at all, Predix will need to raise
additional funding to continue operating. Predixs future
capital requirements will depend on many factors, including:
|
|
|
|
|
the scope and results of Predixs research, pre-clinical
and clinical development activities; |
|
|
|
the timing of, and the costs involved in, seeking regulatory
approvals; |
|
|
|
the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and other patent-related
costs, including litigation costs and the results of such
litigation; |
|
|
|
the extent to which Predix acquires or invest in businesses,
products and technologies; and |
|
|
|
Predixs ability to establish and maintain additional
collaborations, and the financial terms associated with such
collaborations. |
Predix does not anticipate that Predix will generate product
revenue for at least the next several years, if at all. In the
absence of additional funding, Predix expects Predixs
continuing operating losses to result in increases in
Predixs cash used in operations over at least the next
several quarters and years. To the extent Predixs capital
resources are insufficient to meet future capital requirements,
Predix will need to finance future cash needs through public or
private equity offerings, debt financings or corporate
collaboration and licensing arrangements. Except for funding by
CFFT for research and development activities relating to the two
programs covered by the agreement, Predix does not currently
have any commitments for future external funding.
Additional equity or debt financing, or corporate collaboration
and licensing arrangements, may not be available on acceptable
terms, if at all. If adequate funds are not available, Predix
may be required to delay, reduce the scope of or eliminate
Predixs research and development programs, reduce
Predixs planned commercialization efforts, or obtain funds
through arrangements with collaborators or others that may
require Predix to relinquish rights to certain drug candidates
that Predix might otherwise seek to develop or commercialize
independently. Additionally, any future equity funding may
dilute the ownership of Predixs equity investors.
Recent Accounting Pronouncements
In January 2003, the Financial Accounting Standards Board
(FASB) issued Interpretation No. 46, Consolidation
of Variable Interest Entities, which is an interpretation of
Accounting Research Bulletin No. 51, Financial
Statements (FIN 46). FIN 46 requires that if an
entity has a controlling interest in a variable interest entity,
the assets, liabilities and results of activities of the
variable interest entity should be included in the financial
statements of the entity. FIN 46 is effective immediately
for all new variable interest entities created or acquired after
January 31, 2003. For variable interest entities created or
acquired prior to February 1, 2003, the provisions of
FIN 46 (as revised) must be applied to all variable
interests held no later than the first interim or annual period
ending after March 15, 2004. Predix does not own equity or
other variable interests in other companies. Accordingly, the
adoption of FIN 46 did not have an effect on Predixs
consolidated financial statements.
In May 2003, the FASB issued SFAS No. 150,
Accounting for Certain Financial Instruments with
Characteristics of Both Liabilities and Equity
(SFAS No. 150). SFAS No. 150 requires
that certain
192
financial instruments, which under previous guidance were
accounted for as equity, must now be accounted for as
liabilities. The financial instruments affected include
mandatory redeemable stock, certain financial instruments that
require or may require the issuer to buy back some of its shares
in exchange for cash or other assets and certain obligations
that can be settled with shares of stock. SFAS No. 150
is effective for all financial instruments entered into or
modified after.
May 31, 2003 and otherwise is effective beginning with the
first interim period after June 15, 2003. Predix has not
issued any financial instruments which would be affected by the
adoption of SFAS No. 150. Accordingly, the adoption of
SFAS No. 150 did not have an effect on Predixs
financial statements.
In December 2004, the FASB issued FASB Statement No. 123
(revised 2004), Share-Based Payment
(Statement 123(R)), which is a revision of FASB
Statement No. 123, Accounting for Stock-Based
Compensation (Statement 123). Statement 123(R)
supersedes APB Opinion No. 25, Accounting for Stock
Issued to Employees (Opinion 25), and amends FASB Statement
No. 95, Statement of Cash Flows. Generally, the
approach in Statement 123(R) is similar to the approach
described in Statement 123. However, Statement 123(R)
requires all share-based payments to employees, including grants
of employee stock options, to be recognized in the income
statement based on their fair values. Pro forma disclosure is no
longer an alternative. Statement 123(R) is effective for
annual periods beginning after June 15, 2005 and, thus,
will be effective for Predix beginning with the first quarter of
2006. Early adoption is encouraged.
Statement 123(R) permits public companies to adopt its
requirements using one of two methods: (1) a modified
prospective method in which compensation cost is
recognized beginning with the effective date (a) based on
the requirements of Statement 123(R) for all share-based
payments granted after the effective date and (b) based on
the requirements of Statement 123 for all awards granted to
employees prior to the effective date of Statement 123(R)
that remain unvested on the effective date; or (2) a
modified retrospective method which includes the
requirements of the modified prospective method described above,
but also permits entities to restate based on the amounts
previously recognized under Statement 123 for purposes of
pro forma disclosures either (a) all prior periods
presented or (b) prior interim periods of the year of
adoption. Predix plans to adopt Statement 123(R) using the
modified prospective method.
As permitted by Statement 123, Predix currently accounts
for share-based payments to employees using Opinion 25s
intrinsic value method and, as such, generally recognize no
compensation cost for employee stock options. Accordingly, the
adoption of Statement 123(R)s fair value method will
have a significant impact on Predixs results of
operations, although it will have no impact on Predixs
overall financial position. The impact of adoption of
Statement 123(R) cannot be predicted at this time because
it will depend on levels of share-based payments granted in the
future. However, had Predix adopted Statement 123(R) in
prior periods, the impact of that standard would have
approximated the impact of Statement 123 as described in
the disclosure of pro forma net income and earnings per share in
note 2 to Predixs consolidated financial statements.
Statement 123(R) also requires the benefits of tax
deductions in excess of recognized compensation cost to be
reported as a financing cash flow, rather than as an operating
cash flow as required under current literature. This requirement
will reduce net operating cash flows and increase net financing
cash flows in periods after adoption. While Predix cannot
estimate what those amounts will be in the future (because they
depend on, among other things, when employees exercise stock
options), there were no operating cash flows recognized in prior
periods for such excess tax deductions because Predix has had
operating losses since inception.
193
Quantitative and Qualitative Disclosure about Market Risks
Predixs exposure to market risk is currently confined to
Predixs cash and cash equivalents that have maturities of
less than one year. Predix currently does not hedge interest
rate exposure. Predix has not used derivative financial
instruments for speculation or trading purposes. Because of the
short-term maturities of Predixs cash and cash
equivalents, Predix does not believe that an increase in market
rates would have any significant impact on the realized value of
Predixs investments.
Predix has operated primarily in the United States and Israel
and has received payments from Predixs collaborators and
subsidiaries in U.S. dollars. Predixs Israeli
subsidiary conducts its business using New Israeli Shekels.
However, Predix does not believe Predix has any material
exposure to foreign currency rate fluctuations.
Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure
None.
194
PREDIX PRINCIPAL STOCKHOLDERS
The following table and the related notes present information on
the beneficial ownership of shares of Predix common stock and
preferred stock, including Series C preferred stock, as of
March 31, 2006 by each director and executive officer of
Predix and by each person or group who is known to the
management of Predix to be the beneficial owner of more than 5%
of the Predix common stock outstanding as of October 31,
2005. Unless otherwise indicated in the footnotes to this table
and subject to community property laws where applicable and the
voting agreements entered into by certain directors of Predix
(including affiliated entities) with EPIX, Predix believes that
each of the stockholders named in this table has sole voting and
investment power with respect to the shares indicated as
beneficially owned.
The number of shares beneficially owned below assumes the
conversion of all 273,203,492 shares of Predix preferred
stock into 15,177,898 shares of common stock. Applicable
percentages are based on 10,912,838 shares of Predix
Series C preferred stock (on an as-converted to Predix
common stock basis), 15,177,898 shares of Predix preferred
stock (on an as-converted to Predix common stock basis)and
16,221,957 shares of Predix common stock and preferred
stock outstanding on March 31, 2006, adjusted as required
by rules promulgated by the Securities and Exchange Commission.
In addition, shares of common stock that may be acquired by an
individual or group within 60 days of March 31, 2006,
pursuant to the exercise of options or warrants, are deemed to
be outstanding for the purpose of computing the percentage
ownership of such individual or group, but are not deemed to be
outstanding for the purpose of computing the percentage
ownership of any other person shown in the table. Unless
otherwise indicated, the address for each director and executive
officer listed is: c/o Predix Pharmaceuticals Holdings,
Inc., 4 Maguire Road, Lexington, Massachusetts 02421.
|
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|
Percent of | |
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|
Number of | |
|
Percent of | |
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|
Preferred | |
|
|
Shares | |
|
Series C | |
|
Percent of | |
|
Stock and | |
|
|
Beneficially | |
|
Preferred | |
|
Preferred | |
|
Common | |
5% Stockholders: |
|
Owned(1) | |
|
Stock | |
|
Stock | |
|
Stock(2) | |
|
|
| |
|
| |
|
| |
|
| |
OrbiMed Entities(3)
|
|
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3,463,565 |
|
|
|
11.6 |
% |
|
|
22.2 |
% |
|
|
21.2 |
% |
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767 Third Avenue,
30th Floor
New York, NY 10017-2023 |
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Yozma Entities(4)
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|
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1,627,887 |
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|
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5.5 |
|
|
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10.7 |
|
|
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10.0 |
|
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Ramat Aviv Tower,
11th Floor
40 Einstein Street
Tel Aviv, 69102
Israel |
|
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PA International Limited(5)
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|
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1,028,054 |
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8.2 |
|
|
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5.9 |
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6.3 |
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123 Buckingham Palace Road
London SW1 W9SR
United Kingdom |
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SR One Limited(6)
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|
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1,521,331 |
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|
|
11.6 |
|
|
|
9.9 |
|
|
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9.4 |
|
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Four Tower Bridge
200 Barr Harbor Drive, Suite 250
West Conshohocken, PA 19428-2977 |
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Forward Ventures V, L.P.(7)
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1,386,556 |
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12.7 |
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|
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9.1 |
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8.5 |
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9350 Towne Centre Drive, Suite 200
San Diego, CA 92121 |
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Boston Millennia Entities(8)
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|
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1,294,468 |
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|
|
11.6 |
|
|
|
8.3 |
|
|
|
8.0 |
|
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30 Rowes Wharf, Suite 500
Boston, MA 02110 |
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Astellas Venture Capital LLC (formerly known as
Yamanouchi Venture Capital, LLC)(9)
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882,354 |
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8.1 |
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5.8 |
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5.4 |
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2180 San Hill Road, Suite 460
Menlo Park, CA 94025 |
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CMEA Entities(10)
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1,168,417 |
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10.4 |
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7.5 |
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7.2 |
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One Embarcadero Center, Suite 3250
San Francisco, CA 94111 |
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195
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|
Percent of | |
|
|
Number of | |
|
Percent of | |
|
|
|
Preferred | |
|
|
Shares | |
|
Series C | |
|
Percent of | |
|
Stock and | |
|
|
Beneficially | |
|
Preferred | |
|
Preferred | |
|
Common | |
5% Stockholders: |
|
Owned(1) | |
|
Stock | |
|
Stock | |
|
Stock(2) | |
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Directors and Named Executive Officers
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Michael G. Kauffman, M.D., Ph.D.(11)
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433,486 |
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* |
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* |
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2.5 |
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Chen Schor, CPA(12)
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140,888 |
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* |
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* |
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* |
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Kimberlee C. Drapkin, CPA(13)
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34,449 |
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* |
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* |
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* |
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Silvia Noiman, Ph.D.(14)
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199,279 |
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* |
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* |
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1.2 |
|
Oren Becker, Ph.D.
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187,573 |
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* |
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* |
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* |
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Frederick Frank(15)
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40,830 |
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* |
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|
* |
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* |
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Julian Adams, Ph.D.(16)
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5,972 |
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* |
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* |
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* |
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David Collier, M.D.(17)
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1,890 |
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* |
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* |
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* |
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Yigal Erlich(18)
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1,630,054 |
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5.5 |
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10.7 |
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10.0 |
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Patrick J. Fortune, Ph.D.(19)
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1,296,358 |
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11.6 |
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8.3 |
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8.0 |
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Ted Love, M.D.(20)
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5,972 |
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* |
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* |
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* |
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Joel Martin, Ph.D.(21)
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1,388,446 |
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12.7 |
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9.1 |
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8.6 |
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Jonathan Silverstein(22)
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3,465,871 |
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11.6 |
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22.2 |
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21.2 |
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Ian F. Smith, CPA, ACA(23)
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5,555 |
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* |
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* |
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* |
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Executive officers and directors as a group (15 persons)(24)
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8,866,164 |
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41.4 |
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79.5 |
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51.4 |
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(1) |
Includes shares of common stock issuable pursuant to options and
warrants exercisable within 60 days of March 31, 2006. |
|
(2) |
Predix preferred stock is reported on an as-converted to Predix
common stock basis. |
|
(3) |
Includes 50,091 shares held by OrbiMed Associates LLC;
346,463 shares held by EatonVance Worldwide Health Sciences
Portfolio; 207,877 shares held by Hare and Company FAO:
Finsbury Worldwide Pharma; 2,057,481 shares held by
Caduceus Private Investment, L.P.; and 700,974 shares held
by UBS PW Juniper Crossover Fund, LLC. Also includes
2,742 shares of common stock issuable to Hare and Company
FAO: Finsbury Worldwide Pharma upon the exercise of outstanding
warrants; 1,747 shares issuable to OrbiMed Associates LLC
upon the exercise of outstanding warrants; 71,746 shares
issuable to Caduceus Private Investment, L.P. upon the exercise
of outstanding warrants; and 24,444 shares issuable to UBS
PW Juniper Crossover Fund, LLC. upon the exercise of outstanding
warrants. Voting and/or dispositive decisions with respect to
the shares held by OrbiMed Associates LLC, EatonVance Worldwide
Health Sciences Portfolio, Hare and Company FAO: Finsbury
Worldwide Pharma, Caduceus Private Investment, L.P. and UBS PW
Juniper Crossover Fund, LLC are made by OrbiMeds managing
partner, Samuel D. Isaly. Mr. Isaly disclaims beneficial
ownership of such shares except to the extent of his pecuniary
interest, if any. |
|
(4) |
Consists of 336,984 shares held by Yozma II (Israel),
L.P.; 410,137 shares of common stock owned of record by
Yozma Venture Capital Ltd.; 574,412 shares held by
YVC-Yozma Management & Investments Ltd., as trustee for
Yozma (BVI) L.P.; and 306,354 shares held by PCM
Venture Capital L.P. Voting and/or dispositive decisions with
respect to the shares held by Yozma II (Israel), L.P.,
YVC-Yozma Management & Investments Ltd., as trustee for
Yozma (BVI) L.P., and PCM Venture Capital L.P. are made by
Mr. Erlich, managing partner and one of our directors, Boaz
Goldschmidt, general partner, and directors Udi Angel, Yoav
Doppelt, Nir Bronstein and Eran Gersht. Voting and/or
dispositive decisions with respect to the shares held by Yozma
Venture Capital Ltd. are made by its directors, Mr. Angel
and Mr. Doppelt. Each disclaims beneficial ownership of
such shares except to the extent of their pecuniary interest, if
any. |
|
(5) |
Includes 1,016,231 shares held by PA International Limited.
Also includes 11,823 shares of common stock issuable to PA
International Limited upon the exercise of outstanding warrants.
David Cooke, Chris Garrod and Jon Moynihan are the directors of
PA International Limited and share voting |
196
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and/or dispositive power over the shares held by PA
International Limited. Each disclaims beneficial ownership of
such shares except to the extent of their pecuniary interest, if
any. |
|
(6) |
Includes 1,501,522 shares held by SR One Limited. Also
includes 19,809 shares of common stock issuable to SR One
Limited upon the exercise of outstanding warrants. Voting and/or
dispositive decisions with respect to the shares held by SR One
Limited are made by Adrian G. Rawcliffe, President, Philip L.
Smith, Vice President, and Kent Gossett, Investment Manager.
Each disclaims beneficial ownership of such shares except to the
extent of their pecuniary interest, if any. |
|
(7) |
Voting and/or dispositive decisions with respect to the shares
held by Forward Ventures V, L.P. are made by its members,
Joel Martin, one of our directors, Stuart J.M. Collinson,
Standish M. Fleming, Ivor Royston and Maria C. Walker. Each
disclaims beneficial ownership of such shares except to the
extent of their pecuniary interest, if any. |
|
(8) |
Includes 1,046,887 shares held by Boston Millennia
Partners II Limited Partnership; 149,077 shares held
by Boston Millennia Partners GmbH & Co. KG;
50,148 shares held by Boston Millennia Partners II-A
Limited Partnership; 9,413 shares held by Strategic
Advisors Fund Limited Partnership; and 4,979 shares
held by Boston Millennia Associates II Partnership. Also
includes 28,208 shares of common stock issuable to Boston
Millennia Partners II Limited Partnership upon the exercise
of outstanding warrants; 4,017 shares issuable to Boston
Millennia Partners GmbH & Co. KG upon the exercise of
outstanding warrants; 1,351 shares issuable to Boston
Millennia Partners II-A Limited Partnership upon the
exercise of outstanding warrants; 254 shares issuable to
Strategic Advisors Fund Limited Partnership upon the
exercise of outstanding warrants; and 134 shares issuable
to Boston Millennia Associates II Partnership upon the
exercise of outstanding warrants. Voting and/or dispositive
decisions with respect to the shares held by Boston Millennia
Partners II Limited Partnership, Boston Millennia Partners
GmbH & Co. KG, Boston Millennia Partners II-A
Limited Partnership, Strategic Advisors Fund Limited
Partnership and Boston Millennia Associates II Partnership
are made by the general partners of Boston Millennia Partners,
A. Dana Callow Jr., Martin J. Hernon and Robert S. Sherman. Each
disclaims beneficial ownership of such shares except to the
extent of their pecuniary interest, if any. |
|
(9) |
Voting and/or dispositive decisions with respect to the shares
held by Astellas Venture Capital LLC are made by Yoshitaka
Yoneyama, President and Chief Executive Officer, Kazumasa Saito,
Chief Financial Officer and Treasurer, and Satoshi Nozaki,
Secretary. Each disclaims beneficial ownership of such shares
except to the extent of their pecuniary interest, if any. |
|
|
(10) |
Includes 375,835 shares held by CMEA Ventures Life Sciences
2000, L.P.; 22,599 shares held by CMEA Ventures Life
Sciences 2000, Civil Law Partnership; 719,373 shares held
by CMEA Ventures VI, L.P.; and 16,646 shares held by
CMEA Ventures VI, GmbH & Co. K.G. Also includes
11,254 shares of common stock issuable to CMEA Ventures
Life Sciences 2000, L.P. upon the exercise of outstanding
warrants; 675 shares issuable to CMEA Ventures Life
Sciences 2000, Civil Law Partnership upon the exercise of
outstanding warrants; 21,535 shares issuable to CMEA
Ventures VI, L.P. upon the exercise of outstanding
warrants; and 500 shares issuable to CMEA Ventures VI,
GmbH & Co. K.G. upon the exercise of outstanding warrants.
CMEA Ventures LS Management 2000 L.P. is the general
partner of CMEA Ventures Life Sciences 2000, L.P. and CMEA
Ventures Life Sciences 2000, Civil Law Partnership. David
Collier, one of our directors, Thomas Baruch, Karl Handelsman
and Gordon Hull are the general partners of CMEA Ventures LS
Management 2000 L.P. and share voting and/or dispositive power
over the shares held by CMEA Ventures Life Sciences 2000, L.P.
and CMEA Ventures Life Sciences 2000, Civil Law Partnership.
Each disclaims beneficial ownership of such shares except to the
extent of their pecuniary interest, if any. CMEA
Ventures VI Management L.P. is the general partner of CMEA
Ventures VI, L.P. and CMEA Ventures VI, GmbH & Co. K.G.
Dr. Collier, Mr. Baruch, Mr. Handelsman,
Mr. Hull, Faysal Sohail and James Watson are the general
partners of CMEA Ventures VI Management L.P. and share
voting and/or dispositive power over the shares held by CMEA
Ventures VI, L.P. and CMEA Ventures VI, GmbH & Co. K.G. Each
disclaims beneficial ownership of such shares except to the
extent of their pecuniary interest, if any. |
197
|
|
(11) |
Includes 257,669 shares issuable to Dr. Kauffman upon
exercise of stock options. |
|
(12) |
Includes 45,452 shares issuable to Mr. Schor upon
exercise of stock options. |
|
(13) |
Consists of 6,788 shares issuable to Ms. Drapkin upon
exercise of stock options. |
|
(14) |
Includes 190,807 shares issuable to Dr. Noiman upon
exercise of stock options. |
|
(15) |
Includes 5,448 shares issuable to Mr. Frank upon
exercise of stock options. |
|
(16) |
Consists of 5,972 shares issuable to Dr. Adams upon
exercise of stock options. |
|
(17) |
Consists of 1,890 shares issuable to Dr. Collier upon
exercise of stock options. |
|
(18) |
Includes 2,167 shares issuable to Mr. Erlich upon
exercise of stock options. Also includes 336,984 shares held by
Yozma II (Israel), L.P.; 410,137 shares of common
stock owned of record by Yozma Venture Capital Ltd.; 574,412
shares held by
YVC-Yozma Management
& Investments Ltd., as trustee for Yozma (BVI) L.P.;
and 306,354 shares held by PCM Venture Capital L.P. Voting
and/or dispositive decisions with respect to the shares held by
Yozma II (Israel), L.P.,
YVC-Yozma Management
& Investments Ltd., as trustee for Yozma (BVI) L.P.,
and PCM Venture Capital L.P. are made by Mr. Erlich,
managing partner and one of Predixs directors, Boaz
Goldschmidt, general partner, and directors Udi Angel, Yoav
Doppelt, Nir Bronstein and Eran Gersht. Voting and/or
dispositive decisions with respect to the shares held by Yozma
Venture Capital Ltd. are made by its directors, Mr. Angel
and Mr. Doppelt. Each disclaims beneficial ownership of
such shares except to the extent of their pecuniary interest, if
any. |
|
(19) |
Includes 1,890 shares issuable to Dr. Fortune upon
exercise of stock options. Also includes 1,046,887 shares
held by Boston Millennia Partners II Limited Partnership.;
149,077 shares held by Boston Millennia Partners
GmbH & Co. KG; 50,148 shares held by Boston
Millennia
Partners II-A
Limited Partnership; 9,413 shares held by Strategic
Advisors Fund Limited Partnership; and 4,979 shares held by
Boston Millennia Associates II Partnership. Also includes
28,208 shares of common stock issuable to Boston Millennia
Partners II Limited Partnership upon the exercise of
outstanding warrants; 4,017 shares issuable to Boston
Millennia Partners GmbH & Co. KG upon the exercise of
outstanding warrants; 1,351 shares issuable to Boston
Millennia
Partners II-A
Limited Partnership upon the exercise of outstanding warrants;
254 shares issuable to Strategic Advisors Fund Limited
Partnership upon the exercise of outstanding warrants; and
134 shares issuable to Boston Millennia Associates II
Partnership upon the exercise of outstanding warrants. Voting
and/or dispositive decisions with respect to the shares held by
Boston Millennia Partners II Limited Partnership, Boston
Millennia Partners GmbH & Co. KG, Boston Millennia
Partners II-A
Limited Partnership, Strategic Advisors Fund Limited
Partnership and Boston Millennia Associates II Partnership
are made by the general partners of Boston Millennia Partners,
A. Dana Callow Jr., Martin J. Hernon and Robert S. Sherman.
Each disclaims beneficial ownership of such shares except to the
extent of their pecuniary interest, if any. |
|
(20) |
Includes 5,556 shares issuable to Dr. Love upon
exercise of stock options. |
|
(21) |
Includes 1,890 shares issuable to Dr. Martin upon
exercise of stock options. Also includes 1,386,556 shares
held by Forward Ventures V, L.P. Voting and/or dispositive
decisions with respect to the shares held by Forward Ventures V,
L.P. are made by its members, Joel Martin, one of our directors,
Stuart J.M. Collinson, Standish M. Fleming, Ivor Royston and
Maria C. Walker. Each disclaims beneficial ownership of such
shares except to the extent of their pecuniary interest, if any. |
|
(22) |
Includes 2,306 shares issuable to Mr. Silverstein upon
exercise of stock options. Also includes 50,091 shares held
by OrbiMed Associates LLC; 346,463 shares held by
EatonVance Worldwide Health Sciences Portfolio;
207,877 shares held by Hare and Company FAO: Finsbury
Worldwide Pharma; 2,057,481 shares held by Caduceus Private
Investment, L.P.; and 700,974 shares held by UBS PW Juniper
Crossover Fund, LLC. Also includes 2,742 shares of common
stock issuable to Hare and Company FAO: Finsbury Worldwide
Pharma upon the exercise of outstanding warrants;
1,747 shares issuable to OrbiMed Associates LLC upon the
exercise of outstanding warrants; 71,746 shares issuable to
Caduceus Private Investment, L.P. upon the exercise of
outstanding warrants; and 24,444 shares issuable to UBS PW
Juniper Crossover Fund, LLC upon the exercise of |
198
|
|
|
outstanding warrants. Voting and/or dispositive decisions with
respect to the shares held by OrbiMed Associates LLC, EatonVance
Worldwide Health Sciences Portfolio, Hare and Company FAO:
Finsbury Worldwide Pharma, Caduceus Private Investment, L.P. and
UBS PW Juniper Crossover Fund, LLC are made by OrbiMeds
managing partner, Samuel D. Isaly. Mr. Isaly disclaims
beneficial ownership of such shares except to the extent of his
pecuniary interest, if any. |
|
(23) |
Consists of 5,555 shares issuable to Mr. Smith upon
exercise of stock options. |
|
(24) |
Consists of shares set forth in footnotes 11 through 23,
and 29,987 shares issuable to one executive officer not
named in the table upon exercise of stock options. |
199
DESCRIPTION OF EPIX CAPITAL STOCK
General
EPIXs authorized capital stock consists of
40,000,000 shares of common stock and 1,000,000 shares
of preferred stock, par value $0.01 per share. As
of ,
2006, there
were shares
of EPIX common stock outstanding and no shares of preferred
stock outstanding. In order to consummate the merger, EPIX is
seeking shareholder approval pursuant to this joint proxy
statement/ prospectus to amend its restated certificate of
incorporation to increase the authorized EPIX common stock from
40,000,000 shares to 100,000,000 shares.
Common Stock
The holders of EPIX common stock are entitled to one vote for
each share held of record on all matters voted upon by
EPIXs stockholders and may not cumulate votes. Subject to
the rights of holders of any future series of undesignated
preferred stock which may be designated, each share of the
outstanding common stock is entitled to participate ratably in
any distribution of net assets made to the stockholders in the
liquidation, dissolution or winding up of EPIX and is entitled
to participate equally in dividends if and when declared by the
EPIX board of directors. There are no redemption, sinking fund,
conversion or preemptive rights with respect to shares of EPIX
common stock. All shares of EPIX common stock have equal rights
and preferences.
Preferred Stock
The EPIX board of directors has the authority, without further
stockholder approval, to issue 1,000,000 shares of
preferred stock where defined in one or more series and to fix
the relative rights, preferences, privileges, qualifications,
limitations and restrictions of such preferred stock, including
dividend rights, dividend rates, conversion rights, voting
rights, terms of redemption, redemption prices, liquidation
preferences, sinking fund terms and the number of shares
constituting any series or the designation of such series. The
issuance of preferred stock, while potentially providing
desirable flexibility in connection with possible acquisitions
and other corporate purposes, could have the effect of delaying,
deferring or preventing a change in control of EPIX, which may
discourage bids for EPIX common stock at a premium over the
market price of the common stock and may adversely affect the
market price of, and the voting and other rights of the holders
of, EPIX common stock. EPIX has no present plans to issue any
shares of preferred stock.
Transfer Agent and Registrar
The transfer agent and registrar for EPIX common stock is
Computershare, located at 250 Royall Street, Canton,
Massachusetts, 02021.
Stock Market Listings
EPIX common stock is currently listed on The NASDAQ National
Market under the symbol EPIX.
200
COMPARISON OF RIGHTS OF HOLDERS OF EPIX
COMMON STOCK AND PREDIX COMMON STOCK
EPIX and Predix are both Delaware corporations. The rights of
stockholders of each company are generally governed by the
General Corporation Law of the State of Delaware, or DGCL, and
each companys respective certificates of incorporation and
by-laws. Upon completion of the merger, Predix stockholders will
become EPIX stockholders and EPIXs restated certificate of
incorporation and by-laws of EPIX will govern the rights of
former Predix stockholders.
The following description summarizes the material differences
between the rights of EPIX stockholders and Predix stockholders,
but does not purport to be a complete statement of all those
differences, or a complete description of the specific
provisions referred to in this summary. Stockholders should
carefully read the relevant provisions of the DGCL and
EPIXs and Predixs respective certificates of
incorporation and by-laws. For more information on how to obtain
these documents, see Additional Information
Where You Can Find Additional Information.
Capitalization
EPIX. The authorized capital stock of EPIX consists of
40,000,000 shares of common stock, $0.01 par value per
share, and 1,000,000 shares of preferred stock,
$.01 par value per share. In order to consummate the
merger, EPIX is seeking shareholder approval pursuant to this
joint proxy statement/ prospectus to amend its restated
certificate of incorporation to increase the authorized EPIX
common stock from 40,000,000 shares to
100,000,000 shares.
EPIX Common Stock. As
of there
were
approximately shares
of EPIX common stock outstanding and held of record by
approximately persons.
EPIX common stock is listed on The NASDAQ National Market under
the symbol EPIX. Except as otherwise provided in any
resolution providing for the issue of any series of preferred
stock, holders of EPIX common stock have exclusive voting rights
for the election of directors and for all other purposes.
Holders of EPIX common stock are entitled to one vote per share
on all matters to be voted upon by EPIX stockholders. Neither
the EPIX restated certificate of incorporation nor the EPIX
by-laws authorize cumulative voting. The holders of EPIX common
stock are entitled to receive dividends, if any, as may be
declared from time to time by the EPIX board of directors out of
funds legally available for the payment of dividends, subject to
the rights of any series of preferred stock. In the event of a
liquidation, dissolution or winding up of EPIX, the holders of
EPIX common stock are entitled to share ratably in all assets
remaining after payment of the preferential amounts, if any, to
which the holders of EPIX preferred stock, if any, are entitled.
The EPIX common stock has no preemptive, conversion or other
subscription rights. There are no redemption or sinking fund
provisions applicable to the EPIX common stock. All outstanding
shares of EPIX common stock are fully paid and non-assessable,
and the shares of EPIX common stock to be outstanding upon
completion of the merger will be fully paid and non-assessable.
Computershare is the Transfer Agent and Registrar for the shares
of EPIX common stock.
EPIX Preferred Stock. The EPIX board of directors may
issue up to 1,000,000 shares of EPIX preferred stock in one
or more series and may, subject to the DGCL:
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fix its rights, preferences and restrictions; |
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fix the number of shares and designation of any series; |
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provide voting rights to the shares of any series in addition to
those provided by law; |
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provide conversion privileges to the shares of any series and
the terms and conditions of such conversion; and |
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determine the rights of the shares of any series in the event of
voluntary or involuntary liquidation, dissolution or winding up
of EPIX, and the relative rights of priority, if any, of payment
of shares of any series. |
201
At the date of this prospectus, no shares of EPIX preferred
stock were outstanding. Although EPIX presently does not intend
to do so, the EPIX board of directors may issue EPIX preferred
stock with voting, liquidation, dividend, conversion and such
other rights which could negatively affect the voting power or
other rights of the EPIX common stockholders without the
approval of the EPIX common stockholders. Any issuance of EPIX
preferred stock may delay or prevent a change in control of EPIX.
Predix. The authorized capital stock of Predix consists
of 338,085,813 shares of common stock, $0.01 par value
per share, and 275,298,740 shares of preferred stock,
$0.01 par value per share, which consists of
76,771,672 authorized shares of Series AB preferred
stock, par value $0.01 per share, and
198,527,068 authorized shares of Series C preferred
stock, par value $0.01 per share. All shares of Predix
preferred stock are convertible into common stock on a
18-for-1 basis.
Predix Common Stock. As of March 31, 2006, there
were approximately 1,044,059 shares of Predix common stock
outstanding that were held of record by approximately 118
persons. Holders of Predix common stock are entitled to one vote
per share on all matters to be voted upon by Predix
stockholders. Predix may not declare or pay any dividend on the
common stock unless and until the holders of Series C
preferred stock and Series AB preferred stock then
outstanding, have first received or simultaneously receive a
dividend on each outstanding share calculated in accordance with
the Predix restated certificate of incorporation, as amended. In
the event of a liquidation, dissolution or winding up of Predix,
the holders of Predix common stock are entitled to share ratably
in all assets remaining after payment of liabilities of Predix
and of the preferential amounts, if any, to which the holders of
Predix preferred stock are entitled. The Predix common stock has
no preemptive, conversion or other subscription rights. All
outstanding shares of Predix common stock are fully paid and
non-assessable.
Predix Preferred Stock. The holders of shares of
Series C preferred stock are entitled to receive
non-cumulative dividends at an annual rate of 8% of the purchase
price of one share of Series C preferred stock per annum.
Upon the occurrence of a liquidation event, each holder of
Series C preferred stock is entitled to be paid out of the
assets available for distribution before any payment is made to
the holders of shares of Series AB preferred stock and any
other class or series of capital stock that is not senior to the
Series C preferred stock. Second, each holder of
Series AB preferred stock is entitled to be paid out of the
assets available for distribution before any payment is made to
the holders of any class or series of capital stock that is not
senior to the Series AB preferred stock. The remaining
assets of Predix, if any, are distributed pro rata among all
holders of capital stock; provided that the holders of Predix
preferred stock shall not receive in the aggregate an amount
equal to three times the original purchase price of such shares
of Predix preferred stock.
Subject to the approval of the holders of at least 60% of the
outstanding shares of Predix preferred stock, the Predix board
of directors may, subject to the DGCL:
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alter or change the rights, preferences or privileges of any
series of Predix preferred stock; |
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authorize, create or designate any shares of capital stock or
other securities of Predix (including securities convertible
into or exercisable for any such security) with preference to or
on parity with the Series C preferred stock with respect to
dividends, liquidation, redemption, voting or the like; |
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increase the authorized number of shares of Predix preferred
stock, Predix common stock or any series thereof; and |
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authorize or effect any merger or consolidation of Predix with
or into any other company or entity, or any sale, license as
licensor, lease as lessor, or other transfer or disposal of all
or substantially all of the assets of Predix. |
202
Subject to the approval of the holders of at least
662/3
% of the Series C preferred stock, the Predix board
of directors may, subject to the DGCL:
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alter or change the rights, preferences or privileges of any
series of Predix preferred stock; |
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authorize, create or designate any shares of capital stock or
other securities of Predix (including securities convertible
into or exercisable for any such security) with preference to or
on parity with the Series C preferred stock with respect to
dividends, liquidation, redemption, voting or the like; |
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increase or decrease the authorized number of shares of Predix
preferred stock, Predix common stock or any series thereof; |
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increase or decrease the authorized size of the Predix board of
directors in excess of, or to less than, ten members; |
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authorize or effect any merger or consolidation of Predix with
or into another company or entity, or any sale, license as
licensor, lease as lessor, spin off, sale of voting control,
partnering transaction or other transfer or disposal of all or a
substantial portion of Predixs assets outside of the
ordinary course of business; |
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effect any recapitalization or reorganization of any class of
outstanding capital stock of Predix; |
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authorize or effect any transaction or series of related
transactions resulting in a liquidation event; and |
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purchase, lease or otherwise acquire all or substantially all of
the assets or capital stock of another entity (whether by
merger, consolidation, asset purchase or otherwise). |
As of the date of this prospectus, 273,203,492 shares of
Predix preferred stock were outstanding that were held of record
by approximately 63 persons. Although Predix presently does not
intend to do so, the Predix board of directors may issue Predix
preferred stock with voting, liquidation, dividend, conversion
and such other rights which could negatively affect the voting
power or other rights of the Predix common stockholders without
the approval of the Predix common stockholders.
Number, Election, Vacancy and Removal of Directors
Delaware General Corporation Law. Under the DGCL, the
board of directors must have at least one director. A majority
of the directors in office can fill any vacancy or newly created
directorship. A director may be removed with or without cause by
a majority of the shares entitled to vote at an election of the
directors. However, if the board of directors is divided into
classes, unless the certificate of incorporation provides
otherwise, a director may only be removed for cause. The board
of directors may fill any vacancy created for any reason.
EPIX. The EPIX board of directors currently has
five members. The EPIX restated certificate of
incorporation and by-laws provide that the number of directors
shall be fixed from time to time by resolution adopted by the
vote of a majority of the directors then in office, but shall in
no event be less then three. The EPIX restated certificate of
incorporation provides that that EPIX board of directors shall
be divided into three nearly equal classes, with each
class terms expiring on a staggered basis. Vacancies and
newly created directorships may be filled by a majority of the
directors then in office, though less than a quorum. Directors
may be removed for cause by the affirmative vote of the holders
of at least a majority of the stock entitled to vote at a
special meeting of the stockholders called at least in part for
that purpose; such method being the exclusive method for the
removal of directors.
Predix. The Predix board of directors currently has ten
members. In order to increase or decrease the number of
directors to a number greater than or less than ten, Predix must
obtain the approval of the holders of at least
662/3
% of the Series C preferred stock. The Predix
by-laws provide that the Predix board of directors shall consist
of not less than one director. The number of directors may be
declared at any time either by the shareholders or by a majority
of the directors then in office, but may only be decreased to
eliminate vacancies existing by reason of the death,
resignation, removal or expiration of the term of one
203
or more directors. Directors may be removed at any time for
cause by the affirmative vote of a majority of the combined
voting power of the then outstanding shares of Predix capital
stock entitled to vote in the election of directors, voting
together as a single class, except that directors elected by the
holders of a particular class or series of stock may be removed
without cause only by the vote of the holders of a majority of
the outstanding shares of such class or series.
Amendments to Certificate of Incorporation
Delaware General Corporation Law. Under the DGCL, an
amendment to a corporations certificate of incorporation
requires approval by both the board of directors and a majority
of the shares entitled to vote, unless a different proportion is
provided for in the certificate of incorporation. If the
amendment increases or decreases the aggregate number of
authorized shares of a class, then the outstanding shares of
such class shall be entitled to vote on the amendment, whether
or not entitled to vote thereon by the certificate of
incorporation. If the corporations stock is divided into
classes, then a majority of each class entitled to vote on the
amendment as a class must approve the amendment, unless a
different proportion is provided by the certificate of
incorporation.
EPIX. The EPIX restated certificate of incorporation may
be amended or repealed as permitted or prescribed by applicable
law, with all rights conferred upon EPIX stockholders subject to
such reservation. The EPIX restated certificate of incorporation
requires the affirmative vote of holders of
662/3
% of the voting power of the shares of all classes of
EPIX stock entitled to vote for the election of directors,
considered for these purposes as one class of stock, with
respect to amending, revising or revoking certain of its
provisions. Specifically, such vote is required to amend, revise
or revoke the following provisions of the EPIX restated
certificate of incorporation:
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Article Sixth, which sets forth the election and removal
procedures of the EPIX board of directors; |
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Article Eleventh, which sets forth the stockholder voting
requirements for certain actions to be taken by EPIX; and |
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Article Twelfth, which prohibits EPIX stockholder action to
be taken by written consent. |
In addition, any amendment or repeal of Article Ninth of
the EPIX restated certificate of incorporation, which limits the
liability of directors, will not deprive a director of the
benefits of Article Ninth with respect to any act or
omission occurring prior to the date of such amendment or repeal.
Predix. Subject to certain voting rights of the Predix
preferred stock which may not be amended, repealed or modified
without the requisite approval of the holders of Predix
preferred stock, the Predix restated certificate of
incorporation, as amended, may be amended or repealed as
permitted or prescribed by applicable law. In addition, any
amendment, repeal or modification of or the adoption of any
provision inconsistent with Article VII of the Predix
restated certificate of incorporation, as amended, shall not
adversely affect or diminish the rights of any indemnitee to
indemnification with respect to any action, suit or proceeding
arising out of or relating to any actions or facts that occur
prior to such amendment, modification or repeal.
Amendments to By-laws
EPIX. The EPIX by-laws may be altered, amended or
repealed or new by-laws may be adopted by the affirmative vote
of the holders of a majority of the shares of EPIX capital stock
issued and outstanding and entitled to vote at any regular
meeting of stockholders, or at any special meeting of
stockholders provided that notice of such alteration, amendment,
repeal or adoption of new by-laws shall have been stated in the
notice of such meeting; or by the affirmative vote of a majority
of the directors present at any regular or special meeting of
the EPIX board of directors at which a quorum is present.
Predix. The Predix by-laws may be altered, amended or
repealed and new by-laws adopted by the stockholders at any
annual or special stockholder meeting by a majority of the
combined voting power of the outstanding shares of Predix
capital stock entitled to vote at such meeting, voting together
as a single
204
class, or by the approval of a majority of the Predix board of
directors present at any regular or special meeting of the
Predix board of directors at which a quorum is present.
Stockholder Action
EPIX. The affirmative vote of holders of
662/3
% of the voting power of the shares of all classes of
EPIX stock entitled to vote for the election of directors,
considered for these purposes as one class of stock is required
(a) to amend, revise or revoke those articles of the EPIX
restated certificate of incorporation noted above under
Amendments to Certificate of Incorporation or
(b) for EPIX to enter certain transactions with any person,
firm, corporation or other entity, other than a subsidiary of
EPIX, which is the beneficial owner of 5% or more of the shares
of stock of EPIX entitled to vote in the election of directors,
which is referred to as an Other Corporation. Otherwise, the
holders of a majority in interest of all stock issued and
outstanding and entitled to vote at any meeting of the
stockholders shall constitute a quorum and a majority of the
stock represented thereat is required for EPIX stockholders to
approve any action brought before them. Any election by
stockholders shall be determined by a plurality of the vote cast
by the stockholders entitled to vote at the election. The EPIX
restated certificate of incorporation provides that any action
required or permitted to be taken by stockholders at any annual
or special meeting may not be effected by written consent.
Predix. The vote of a majority of the shares present and
entitled to vote at a duly called and held meeting is the act of
the Predix stockholders. The Predix by-laws provide that any
action required or permitted to be taken by the stockholders at
a duly called annual or special meeting may be affected by the
written consent of the holders of outstanding stock having not
less than the minimum number of votes that would be required to
authorize or take such action at a meeting at which all shares
entitled to vote on such action were present and voted.
Notice of Certain Stockholder Actions
EPIX. The EPIX by-laws state that a stockholder may only
bring business before an annual stockholder meeting, including
nomination of a director for the EPIX board of directors at an
annual or special stockholder meeting, if the stockholder gives
written notice of the business to the Chairman of the EPIX board
of directors or EPIXs President, Secretary or Treasurer
not less than 50 days nor more than 75 days prior to
the meeting or, if less than 65 days notice or prior
public disclosure of the date of the meeting is given or made to
stockholders, stockholder notice, to be timely, must be received
no later than the close of business on the
15th day
following the day on which such notice of the date of the annual
meeting was mailed or such public disclosure was made.
Predix. The Predix by-laws do not have an advance notice
requirement for a Predix stockholder to properly bring business
before a stockholder meeting.
Special Stockholder Meetings
Delaware General Corporation Law. Under the DGCL, a
special meeting of a corporations stockholders may be
called by the board of directors or by any other person
authorized by the corporations certificate of
incorporation or by-laws. All stockholders of record entitled to
vote must receive notice of all stockholder meetings not less
than ten, nor more than 60, days before the date of the
stockholder meeting.
EPIX. The EPIX by-laws provide that the President or the
EPIX board of directors may call special meetings of the
stockholders at any time.
Predix. The Predix by-laws provide that only the Predix
board of directors, the Chairman of the Predix board of
directors or Predixs President can call a special meeting
of the Predix stockholders. No business may be transacted at a
special meeting of the stockholders other than that stated in
the notice of the meeting.
205
Limitation of Personal Liability of Directors and
Indemnification
Delaware General Corporation Law. Under the DGCL, a
corporation may include a provision in its certificate of
incorporation eliminating or limiting the personal liability of
a director to the corporation or its stockholders for certain
monetary damages resulting from breaches of fiduciary duties.
Specifically, the corporation may indemnify any director,
officer, employee or agent of the corporation for expenses,
monetary damages, fines and settlement amounts to the extent the
person:
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acted in good faith; |
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acted in a manner he or she believed to be in the best interests
of the corporation; and |
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with respect to any criminal action, had no reasonable cause to
believe the conduct was unlawful. |
However, no provision can eliminate or limit director liability
for any:
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breach of his or her duty of loyalty to the corporation or its
stockholders; |
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act or omission not in good faith or involving intentional
misconduct or a knowing violation of the law; |
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violation of Section 174 of the DGCL regarding unlawful
payment of dividends or unlawful stock purchases or redemptions; |
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transaction from which the director received any improper
personal benefit; or |
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act or omission that took place before the date of adoption of
the provision in the certificate of incorporation eliminating or
limiting the liability of a director for breaches of fiduciary
duties. |
Indemnification is also not permitted if the person is held
liable to the corporation or its stockholders, except to the
extent that an appropriate court concludes that the person is
fairly and reasonably entitled to indemnification for those
expenses that the court deems proper.
EPIX. The EPIX restated certificate of incorporation
provides that directors shall not be personally liable for
monetary damages for breach of fiduciary duty, except to the
extent such elimination or limitation thereof is not permitted
under the DGCL as in effect when such liability is determined.
Any amendment or repeal of this provision in the EPIX restated
certificate of incorporation will not deprive a director of its
benefits with respect to any act or omission occurring prior to
such amendment or repeal. In addition, the EPIX restated
certificate of incorporation and by-laws provide that, to the
fullest extent permitted by the DGCL, as amended from time to
time, EPIX shall indemnify its directors and officers and those
who serve at the request of EPIX as a director, officer or
trustee with another corporation, partnership, joint venture,
trust or other enterprise. This right to indemnification may
include advancement of expenses and is not exclusive of any
other right the indemnified party may have. The EPIX restated
certificate of incorporation authorizes EPIX to grant
indemnification rights to other employees, agents or other
persons serving EPIX and such rights may be equivalent to, or
greater or less than, those provided by the EPIX restated
certificate of incorporation.
Even if EPIX is prohibited from indemnifying such persons under
the DGCL, it may maintain insurance on behalf of any person who
is or was a director, officer, employee or agent of EPIX or is
or was serving in such capacity at the request of EPIX with
another corporation, partnership, joint venture, trust or other
enterprise against any liability asserted against such person
and incurred by such person in any such capacity or arising out
of such persons status as such. EPIX currently maintains
such insurance and has also entered into customary
indemnification agreements with each of its directors and
executive officers.
Predix. The Predix restated certificate of incorporation,
as amended, provides that, to the fullest extent that the DGCL
as it now exists or as it may be amended permits, directors
shall not be liable to Predix or its stockholders for monetary
damages for breach of fiduciary duties as a director. The Predix
restated certificate of incorporation, as amended, also provides
that, subject to the approval of the Predix board of directors,
to the fullest extent that the DGCL as it now exists or as it
may be amended permits,
206
Predix is authorized to provide indemnification to its agents.
In addition, the Predix restated certificate of incorporation,
as amended, provides a right to indemnification of and
advancement of expenses to directors, officers, employees and
certain agents of Predix. This right to indemnification and
advancement of expenses is not exclusive of any other rights to
which directors, officers, employees or agents are entitled.
Even if Predix is prohibited from indemnifying such persons
under the DGCL, it may maintain insurance at its expense to
protect itself and any director, officer, employee or agent
against liability. Predix currently maintains such insurance.
Mergers, Acquisitions and Other Transactions
Delaware General Corporation Law. Under the DGCL, the
board of directors and a majority of the shares entitled to vote
must approve a merger, consolidation or sale of all or
substantially all of a corporations assets. However,
unless the corporation provides otherwise in its certificate of
incorporation, no stockholder vote of a constituent corporation
surviving a merger is required if:
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the merger agreement does not amend the constituent
corporations certificate of incorporation; |
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each share of stock of the constituent corporation outstanding
before the merger is an identical outstanding or treasury share
of the surviving corporation after the merger; and |
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either no shares of common stock of the surviving corporation
are to be issued or delivered by way of the merger or, if common
stock will be issued or delivered, it will not increase the
number of outstanding shares of common stock immediately before
the merger by more than 20%. |
EPIX. The EPIX restated certificate of incorporation
requires a
662/3
vote of the shares of all classes of EPIX stock
entitled to vote for the election of directors, considered as
one class, to authorize EPIX to do any of the following with any
Other Corporation: (a) adopt any agreement for the merger
or consolidation of EPIX or any EPIX subsidiary with or into any
Other Corporation; (b) authorize any sale, lease, exchange,
mortgage, pledge or other disposition of all or substantially
all of the assets of EPIX or any EPIX subsidiary to any Other
Corporation; (c) authorize the issuance or transfer by EPIX
of EPIX securities having a then fair market value of more than
$500,000 in exchange for the securities or assets of any Other
Corporation; or (d) engage in any other transaction the
effect of which is to combine the assets and business of EPIX or
any EPIX subsidiary with any Other Corporation. Because Predix
is not an Other Corporation, the EPIX restated certificate of
incorporation does not alter the required vote of EPIX
stockholders to approve this merger, under the DGCL.
Predix. The Predix restated certificate of incorporation,
as amended, alters the required vote of Predix stockholders to
approve a merger, consolidation or sale of all or substantially
all of Predixs assets under the DCGL such that the
approval of the holders of at least (a) 60% of the
outstanding shares of Predix preferred stock and
(b) 662/3
% of the outstanding shares of Series C preferred
stock is required to approve a merger, consolidation or sale of
all or substantially all of Predixs assets.
Dissenters Appraisal Rights
Delaware General Corporation Law. Under the DGCL,
dissenters appraisal rights are available to a
corporations stockholders in connection with certain
mergers and consolidations. However, no rights are available in
certain situations. A corporations stockholders will not
receive such rights if the corporation is the surviving
corporation and no stockholder vote is required for the merger.
Also, no such rights are available if the corporations
stock is either:
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listed on a national securities exchange, designated as a
national market system security on an interdealer quotation
system by the National Association of Securities Dealers,
Inc., or |
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held of record by more than 2,000 stockholders. |
207
However, dissenters appraisal rights will be available if
the merger or consolidation requires stockholders to exchange
their stock for anything other than:
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shares of the surviving corporation, |
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shares of another corporation that will be listed on a national
securities exchange, designated as a national market system
security on an interdealer quotation system by the National
Association of Securities Dealers, Inc. or held of record by
more than 2,000 stockholders, or |
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cash in place of fractional shares. |
EPIX. Because EPIX meets at least one of the requisite
tests set forth above, its stockholders will not receive
dissenters appraisal rights with respect to the merger.
Predix. Because Predix does not meet any of the requisite
tests set forth above, Predix stockholders will receive
dissenters appraisal rights with respect to the merger. In
the event of a proposed merger or consolidation that is approved
by (a) the Predix board of directors and (b) the
holders of at least
662/3
% of the shares of Series C preferred stock, all
stockholders who are party to Predixs Second Amended and
Restated Stockholders Agreement are obligated to vote
their shares in favor of such a transaction, and those Predix
stockholders voting in favor of the merger will not be entitled
to appraisal rights.
Rights Plan
EPIX. EPIX does not have a stockholder rights plan.
Predix. Predix does not have a stockholder rights plan.
208
EPIX ANNUAL MEETING PROPOSAL NO. 1 APPROVAL
OF THE ISSUANCE OF EPIX
COMMON STOCK IN THE MERGER AND APPROVAL OF THE MERGER
For a summary and detailed information regarding this proposal,
see the information about the merger and the issuance of EPIX
common stock as a result thereof throughout this joint proxy
statement/ prospectus, including the information set forth in
The Merger, The Merger Agreement,
The Voting Agreement, Management of EPIX after
the Merger and The Annual Meeting of EPIX
Stockholders.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
THE ISSUANCE OF SHARES OF EPIX COMMON STOCK IN THE MERGER IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, EPIX AND ITS
STOCKHOLDERS AND HAS APPROVED SUCH ISSUANCE. THE EPIX BOARD OF
DIRECTORS RECOMMENDS THAT EPIX STOCKHOLDERS VOTE FOR
PROPOSAL NO. 1 TO APPROVE THE ISSUANCE OF SHARES OF EPIX
COMMON STOCK IN THE MERGER AND APPROVE THE MERGER.
209
EPIX ANNUAL MEETING PROPOSAL NO. 2 AMENDMENT
OF RESTATED CERTIFICATE OF INCORPORATION TO INCREASE AUTHORIZED
COMMON STOCK
At the EPIX annual meeting, holders of EPIX stock will be asked
to approve the amendment of EPIXs restated certificate of
incorporation to increase the number of authorized shares of
EPIX common stock to 100,000,000.
EPIXs restated certificate of incorporation currently
authorizes 40,000,000 shares of common stock. On
March 31, 2006, 23,284,810 shares of EPIX common stock
were outstanding.
Approximately 23,275,484 shares of EPIX common stock will
be issuable upon the effective time of the merger in exchange of
the outstanding Predix common stock and preferred stock and upon
the exercise of Predix options and warrant assumed by EPIX in
the merger. Based on the shares of EPIX common stock outstanding
and reserved and the shares of Predix stock outstanding and
reserved as of March 31, 2006, assuming the approval of the
increase in the authorized shares of EPIX common stock, and
following the closing of the merger, EPIX would have
approximately 43,538,069 shares of common stock issued,
9,618,901 shares of common stock reserved for issuance
under stock incentive plans, employee stock purchase plan and
warrants, and approximately 46,843,030 shares of common
stock authorized but unissued and unreserved assuming the
approval of increasing the authorized common stock to
100,000,000 shares.
EPIX currently does not have sufficient authorized shares to
complete the merger and it is a condition of the transaction
that the number of authorized shares of EPIX common stock be
increased accordingly. At present, EPIX has no plans to issue
shares for any other purpose. However, the EPIX board of
directors believes it is also desirable to have additional
shares available for other corporate purposes that might arise
in the future, other than in the merger. For example, although
EPIX currently meets its obligations to deliver shares under
employee stock options and similar arrangements with treasury
shares (meaning previously issued shares that have been
reacquired by EPIX), it may become desirable in the future to
use newly issued shares for this purpose. Shares could also be
issued from time to time for acquisitions or to raise capital.
Under some circumstances, it is also possible for a company to
use unissued shares for antitakeover purposes, but EPIX has no
present intention to take any such action.
Whether or not any future issuance of shares unrelated to the
merger would be submitted for stockholder vote depends upon the
nature of the issuance, legal and stock exchange requirements,
and the judgment of the EPIX board of directors at the time.
Votes Required to Approve the Amendment of the Restated
Certificate of Incorporation
The affirmative vote of the holders of a majority of the
outstanding common stock on the record date is required for
approval of the amendment of EPIXs restated certificate of
incorporation.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
AN AMENDMENT TO EPIXS RESTATED CERTIFICATE OF
INCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK FROM 40,000,000 SHARES TO 100,000,000 SHARES, WHICH
REPRESENTS AN ADDITIONAL 60,000,000 SHARES, IS ADVISABLE TO, AND
IN THE BEST INTERESTS OF, EPIX AND ITS STOCKHOLDERS AND HAS
APPROVED SUCH AMENDMENT. THE EPIX BOARD OF DIRECTORS RECOMMENDS
THAT EPIX STOCKHOLDERS VOTE FOR PROPOSAL NO. 2
TO APPROVE AN AMENDMENT TO EPIXS RESTATED CERTIFICATE OF
INCORPORATION TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF
COMMON STOCK FROM 40,000,000 SHARES TO 100,000,000 SHARES. THE
APPROVAL OF PROPOSAL NO. 2 IS NECESSARY TO ENABLE EPIX TO
ISSUE THE REQUIRED NUMBER OF SHARES OF EPIX COMMON STOCK TO
PREDIX STOCKHOLDERS, OPTION HOLDERS AND WARRANT HOLDERS IN
CONNECTION WITH THE MERGER.
210
EPIX ANNUAL MEETING PROPOSAL NO. 3 ELECTION
OF EPIX DIRECTORS
The EPIX board of directors nominated Mark Leuchtenberger and
Peter Wirth for election at the EPIX annual meeting. The EPIX
board of directors currently consists of five members,
classified into three classes as follows: (a) Peter Wirth,
Mark Leuchtenberger and Michael Gilman, Ph.D. constitute a class
with a term ending at the upcoming this 2006 annual stockholders
meeting, or the Class I directors; (b) Christopher
F.O. Gabrieli constitutes a class with a term ending at the 2008
annual meeting, or the Class II director; and
(c) Gregory D. Phelps constitutes a class with a term
ending at the 2007 annual meeting, or the Class III
director. At each annual meeting of stockholders, directors are
elected for a full term of three years to succeed those
directors whose terms are expiring. Peter Wirth has notified
EPIX that he will not stand for reelection to the EPIX board of
directors at the 2006 EPIX annual meeting.
The EPIX board of directors has voted (a) to set the size
of the EPIX board of directors at five members and (b) to
nominate each of Mark Leuchtenberger and Michael Gilman, Ph.D.
for election at the annual meeting for a term of three years to
serve until the 2009 annual meeting of stockholders, and until
their respective successors have been elected and qualified;
provided, however, that, if Proposal No. 1 and
Proposal No. 2 are adopted and the merger is
completed, the EPIX board of directors will consist of the nine
persons identified in this joint proxy statement/ prospectus.
The Class II director and the Class III director will
serve until the annual meetings of stockholders to be held in
2008 and 2007, respectively, and until their respective
successors have been elected and qualified.
Unless authority to vote for any of these nominees is withheld,
the shares represented by the enclosed proxy will be voted
FOR the election as directors of Mark Leuchtenberger and
Michael Gilman, Ph.D.; provided, however, that, if
Proposal No. 1 and Proposal No. 2 are
adopted and the merger is completed, the EPIX board of directors
will consist of the nine persons identified in this joint proxy
statement/ prospectus. In the event that the nominee becomes
unable or unwilling to serve, the shares represented by the
enclosed proxy will be voted for the election of such other
person as the EPIX board of directors may recommend in his/her
place. We have no reason to believe that any nominee will be
unable or unwilling to serve as a director.
Votes Required to Elect Directors
A plurality of the shares voted affirmatively or negatively at
the annual meeting is required to elect each nominee as a
director.
THE EPIX BOARD OF DIRECTORS RECOMMENDS THE ELECTION OF MARK
LEUCHTENBERGER AND MICHAEL GILMAN, PH.D. AS DIRECTORS, AND
PROXIES SOLICITED BY THE BOARD OF DIRECTORS WILL BE VOTED IN
FAVOR THEREOF UNLESS A STOCKHOLDER HAS INDICATED OTHERWISE ON
THE PROXY; PROVIDED, HOWEVER, THAT, IF PROPOSAL NO. 1 AND
PROPOSAL NO. 2 ARE ADOPTED AND THE MERGER IS COMPLETED, THE
EPIX BOARD OF DIRECTORS WILL CONSIST OF THE NINE PERSONS
IDENTIFIED IN THIS JOINT PROXY STATEMENT/ PROSPECTUS.
211
EPIX ANNUAL MEETING PROPOSAL NO. 4
RATIFICATION OF SELECTION OF EPIXS
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The audit committee of the EPIX board of directors has appointed
Ernst & Young LLP, independent public accountants, to
audit EPIXs financial statements for the year ending
December 31, 2006. The EPIX board of directors proposes
that the stockholders ratify this appointment. Ernst &
Young LLP audited EPIXs financial statements for the year
ended December 31, 2005. EPIX expects that representatives
of Ernst & Young LLP will be present at the meeting,
will be able to make a statement if they so desire, and will be
available to respond to appropriate questions.
The following table presents fees for professional audit
services rendered by Ernst & Young LLP for the audit of
EPIXs annual financial statements for the years ended
December 31, 2005 and 2004, and fees billed for tax
services rendered by Ernst & Young LLP during those
periods. The audit committee of the EPIX board of directors
considered the provision of the services corresponding to these
fees in its finding that the services are compatible with
Ernst & Young LLP maintaining its independence.
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
|
| |
|
|
December 31, 2005 | |
|
December 31, 2004 | |
|
|
| |
|
| |
Audit Fees:(1)
|
|
$ |
265,500 |
|
|
$ |
393,000 |
|
Audit-Related Fees:(2)
|
|
|
|
|
|
|
|
|
Tax Fees:(3)
|
|
|
17,700 |
|
|
|
27,872 |
|
All Other Fees:(4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
283,200 |
|
|
|
420,872 |
|
|
|
|
|
|
|
|
|
|
(1) |
Audit Fees consist of fees for professional services rendered
for the audit of EPIXs annual financial statements, a review of
the interim financial statements included in the quarterly
reports, a review of internal controls of financial reporting
(Section 404) and services normally provided by
Ernst & Young LLP in connection regulatory filings, as
well as work generally only the independent auditor can
reasonably be expected to provide, such as statutory audits. |
|
(2) |
Audit-Related Fees consist of fees for assurance and related
services that are reasonably related to the performance of an
audit or review of EPIXs financial statements and are not
reported under Audit Fees. The category includes
fees for the review of EPIXs employee benefit plans. In
2004, EPIX hired an accounting firm other than Ernst &
Young LLP to audit the employee benefit plan. |
|
(3) |
Tax Fees consist of fees for professional services rendered in
preparing the federal and state tax returns, and for providing
tax compliance, tax advice and tax planning assistance. |
|
(4) |
All Other Fees consist of fees for services other than the
services reported above. |
Policy on Audit Committee Pre-Approval of Audit and
Permissible Non-audit Services of Independent Auditors
Consistent with Securities and Exchange Commission policies
regarding auditor independence, the audit committee of the EPIX
board of directors has responsibility for appointing, setting
compensation and overseeing the work of the independent auditor.
In recognition of this responsibility, the audit committee of
the EPIX board of directors has established a policy to
pre-approve all audit and permissible non-audit services
provided by the independent auditor.
Prior to engagement of the independent auditor for the next
years audit, management will submit an aggregate of
services expected to be rendered during that year for each of
four categories of services to the audit committee of the EPIX
board of directors for approval.
1. Audit services include audit work performed in
the preparation of financial statements, as well as work that
generally only the independent auditor can reasonably be
expected to provide, including comfort letters, and attest
services and consultation regarding financial accounting and/or
reporting standards.
212
2. Audit-Related services are for assurance and
related services that are traditionally performed by the
independent auditor, including due diligence related to mergers
and acquisitions, employee benefit plan audits, and special
procedures required to meet certain regulatory requirements.
3. Tax services include all services performed by
the independent auditors tax personnel except those
services specifically related to the audit of the financial
statements, and includes fees in the areas of tax compliance,
tax planning, and tax advice.
4. Other Fees are those associated with services not
captured in the other categories.
Prior to engagement, the audit committee of the EPIX board of
directors pre-approves these services by category of service.
The fees are budgeted and the audit committee of the EPIX board
of directors requires the independent auditor and management to
report actual fees versus the budget periodically throughout the
year by the category of service. During the year, circumstances
may arise when it may become necessary to engage the independent
auditor for additional services not contemplated in the original
pre-approval. In those instances, the audit committee of the
EPIX board of directors requires specific pre-approval before
engaging the independent auditor.
The audit committee of the EPIX board of directors may delegate
pre-approval authority to one or more of its members. The member
to whom such authority is delegated must report, for
informational purposes only, any pre-approval decisions to the
audit committee of the EPIX board of directors at its next
scheduled meeting.
In the event the stockholders do not ratify the appointment of
Ernst & Young LLP as our independent public
accountants, the audit committee of the EPIX board of directors
will reconsider its appointment.
Votes Required to Ratify the Appointment of EPIXs
Independent Registered Public Accounting Firm
The affirmative vote of the holders of a majority of the shares
present at the EPIX annual meeting, whether in person or by
proxy, is required to ratify the appointment of the independent
public accountants.
THE EPIX BOARD OF DIRECTORS RECOMMENDS A VOTE TO RATIFY THE
APPOINTMENT OF ERNST & YOUNG LLP AS INDEPENDENT PUBLIC
ACCOUNTANTS, AND PROXIES SOLICITED BY THE BOARD WILL BE VOTED IN
FAVOR OF SUCH RATIFICATION UNLESS A STOCKHOLDER INDICATES
OTHERWISE ON THE PROXY.
213
EPIX ANNUAL MEETING PROPOSAL NO. 5 APPROVAL
OF POSSIBLE ADJOURNMENT OF
ANNUAL MEETING
If EPIX fails to receive a sufficient number of votes to approve
Proposal Nos. 1 and 2, EPIX may propose to adjourn the
annual meeting, if a quorum is present, for a period of not more
than 30 days for the purpose of soliciting additional
proxies to approve Proposal Nos. 1 and 2. EPIX currently
does not intend to propose adjournment at the annual meeting if
there are sufficient votes to approve Proposal Nos. 1 and 2.
Votes Required to Approve the Adjournment of the Annual
Meeting
The approval to adjourn the EPIX annual meeting requires the
affirmative vote of the holders of a majority of the shares
present at the EPIX annual meeting, whether in person or by
proxy.
THE EPIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT
ADJOURNING THE EPIX ANNUAL MEETING, IF NECESSARY, IF A QUORUM IS
PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT
SUFFICIENT VOTES IN FAVOR OF PROPOSAL NOS. 1 AND 2 IS
ADVISABLE TO, AND IN THE BEST INTERESTS OF, EPIX AND ITS
STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE PROPOSAL. THE EPIX
BOARD OF DIRECTORS RECOMMENDS THAT EPIX STOCKHOLDERS VOTE
FOR PROPOSAL NO. 5 TO ADJOURN THE EPIX ANNUAL
MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT
ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF
PROPOSAL NOS. 1 AND 2.
214
PREDIX SPECIAL MEETING PROPOSAL NO. 1
APPROVAL AND ADOPTION OF THE
MERGER AGREEMENT AND APPROVAL OF THE MERGER
For a summary and detailed information regarding this proposal,
see the information about the merger agreement and the merger
throughout this joint proxy statement/ prospectus, including the
information set forth in The Merger, The
Merger Agreement, The Voting Agreement,
Management of EPIX after the Merger and The
Special Meeting of Predix Stockholders.
THE PREDIX BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES
THAT THE MERGER IS ADVISABLE TO, AND IN THE BEST INTERESTS OF,
PREDIX AND ITS STOCKHOLDERS AND HAS APPROVED THE MERGER AND THE
MERGER AGREEMENT. THE PREDIX BOARD OF DIRECTORS RECOMMENDS THAT
PREDIX STOCKHOLDERS VOTE FOR PROPOSAL NO. 1 TO
APPROVE AND ADOPT THE MERGER AGREEMENT AND TO APPROVE THE
MERGER.
215
PREDIX SPECIAL MEETING PROPOSAL NO. 2
APPROVAL OF POSSIBLE ADJOURNMENT
OF SPECIAL MEETING
If Predix fails to receive a sufficient number of votes to
approve Proposal No. 1, Predix may propose to adjourn
the special meeting, if a quorum is present, for a period of not
more than 30 days for the purpose of soliciting additional
proxies to approve Proposal No. 1. Predix currently
does not intend to propose adjournment at the special meeting if
there are sufficient votes to approve Proposal No. 1.
THE PREDIX BOARD OF DIRECTORS HAS CONCLUDED THAT THE
PROPOSAL TO ADJOURN THE PREDIX SPECIAL MEETING, IF
NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT ADDITIONAL PROXIES
IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF THE FOREGOING
PROPOSAL NO. 1 IS ADVISABLE TO, AND IN THE BEST INTERESTS
OF, PREDIX AND ITS STOCKHOLDERS AND HAS APPROVED AND ADOPTED THE
PROPOSAL. ACCORDINGLY, THE PREDIX BOARD OF DIRECTORS RECOMMENDS
THAT PREDIX STOCKHOLDERS VOTE FOR PROPOSAL NO.
2 TO ADJOURN THE PREDIX SPECIAL MEETING, IF NECESSARY, IF A
QUORUM IS PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE
NOT SUFFICIENT VOTES IN FAVOR OF PROPOSAL NO. 1.
216
EXPERTS
The financial statements of EPIX Pharmaceuticals, Inc. at
December 31, 2005 and 2004, and for each of the three years
in the period ended December 31, 2005, included in the
joint proxy statement of EPIX Pharmaceuticals, Inc. which is
referred to and made a part of this prospectus and registration
statement, have been audited by Ernst and Young LLP, independent
registered public accounting firm, as set forth in their report,
appearing elsewhere herein, and are included in reliance upon
such report given on the authority of said firm as experts in
accounting and auditing.
The consolidated financial statements of Predix Pharmaceuticals
Holdings, Inc. at December 31, 2005 and 2004, and for each
of the three years in the period ended December 31, 2005,
included in the joint proxy statement of Predix Pharmaceuticals
Holdings, Inc. which is referred to and made a part of this
prospectus and registration statement, have been audited by
Ernst and Young LLP, independent auditors, as set forth in their
report (which contains an explanatory paragraph describing
conditions that raise substantial doubt about the companys
ability to continue as a going concern as described in
Note 1 to the consolidated financial statements), appearing
elsewhere herein, and are included in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
LEGAL MATTERS
The validity of the shares of EPIX common stock offered hereby
and certain tax matters will be passed upon for EPIX by Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo P.C., Boston,
Massachusetts. Certain tax matters will be passed upon for
Predix by Goodwin Procter LLP, Boston, Massachusetts.
STOCKHOLDER PROPOSALS
EPIXs by-laws provide that in order for a stockholder to
bring business before or propose director nominations at an
annual meeting, the stockholder must give written notice to
EPIXs Secretary not less than 50 days, nor more than
75 days prior to the meeting. The notice must contain
specified information about the proposed business of each
nominee and the stockholder making the proposal or nomination.
If less than 65 days notice or prior public disclosure of
the date of the annual meeting is given or made to stockholders,
the notice given by the stockholder must be received not later
than the 15th day following the day on which the notice of
such annual meeting date was mailed or public disclosure made,
whichever first occurs. Proposals that are not received within
the time frames set for the above will not be voted on at the
annual meeting. If a proposal is received within these time
frames, the proxies that management solicits for the meeting may
still exercise discretionary voting authority on the proposal
under circumstances consistent with the proxy rules of the
Securities and Exchange Commission. All stockholder proposals
should be marked for the attention of Secretary, EPIX
Pharmaceuticals, Inc., 161 First Street, Cambridge,
Massachusetts 02142.
217
WHERE YOU CAN FIND MORE INFORMATION
EPIX has filed reports, proxy statements and other information
with the Securities and Exchange Commission. Copies of
EPIXs reports, proxy statements and other information may
be inspected and copied at the public reference facilities
maintained by the Securities and Exchange Commission at the
Securities and Exchange Commissions Headquarters, Public
Reference Section, 100 F Street, N.E., Washington D.C. 20549.
The public may obtain information on the operation of the
Securities and Exchange Commissions public reference
facilities by calling the Securities and Exchange Commission at
1-800-SEC-0330.
Copies of these materials can also be obtained by mail at
prescribed rates from the Public Reference Section of the
Securities and Exchange Commission at the Securities and
Exchange Commissions Headquarters or by calling the
Securities and Exchange Commission at
1-800-SEC-0330. The
Securities and Exchange Commission maintains a website that
contains reports, proxy statements and other information
regarding EPIX. The address of the Securities and Exchange
Commissions website is http://www.sec.gov.
Reports, proxy statements and other information concerning EPIX
may also be inspected at The National Association of Securities
Dealers, 1735 K Street N.W., Washington, D.C.
20006.
The following documents are incorporated by reference into this
joint proxy statement/ prospectus:
|
|
|
|
(a) |
EPIXs Annual Report on
Form 10-K for the
year ended December 31, 2005 filed on March 1, 2006
(File No. 000-21863); |
|
|
(b) |
EPIXs Current Report on
Form 8-K filed on
February 1, 2006 reporting the February 1, 2006 event
(File No. 000-21863); |
|
|
(c) |
EPIXs Current Report on
Form 8-K filed on
February 16, 2006 reporting the February 10, 2006
event (File No. 000-21863); |
|
|
(d) |
EPIXs Current Report on
Form 8-K filed on
March 9, 2006 reporting the March 7, 2006 event (File
No. 000-21863); and |
|
|
(e) |
EPIXs Current Report on
Form 8-K filed on
April 3, 2006 reporting the April 3, 2006 event (File
No. 000-21863). |
All documents filed by EPIX following the date of this joint
proxy statement/ prospectus and prior to the date of the EPIX
annual meeting pursuant to Section 13(a), 13(c), 14 or
15(d) of the Securities Exchange Act of 1934, as amended, shall
be deemed to be incorporated by reference into this joint proxy
statement/ prospectus.
You should rely only on the information contained in this joint
proxy statement/ prospectus or on information to which EPIX has
referred you. EPIX and Predix have not authorized anyone else to
provide you with any information. EPIX provided the information
concerning EPIX. Predix provided the information concerning
Predix.
EPIX has filed a registration statement under the Securities Act
of 1933, as amended, with the Securities and Exchange Commission
with respect to EPIX common stock to be issued to Predix
stockholders in the merger. This joint proxy statement/
prospectus constitutes the prospectus of EPIX filed as part of
the registration statement. This joint proxy statement/
prospectus does not contain all of the information set forth in
the registration statement because certain parts of the
registration statement are omitted as provided by the rules and
regulations of the Securities and Exchange Commission. You may
inspect and copy the registration statement at any of the
addresses listed above.
218
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
EPIX FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
F-3 |
|
|
|
|
F-4 |
|
|
|
|
F-5 |
|
|
|
|
F-6 |
|
|
|
|
F-7 |
|
PREDIX CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
F-26 |
|
|
|
|
F-27 |
|
|
|
|
F-28 |
|
|
|
|
F-29 |
|
|
|
|
F-30 |
|
|
|
|
F-31 |
|
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
EPIX Pharmaceuticals, Inc.:
We have audited the accompanying balance sheets of EPIX
Pharmaceuticals, Inc. (formerly EPIX Medical, Inc.) as of
December 31, 2005 and 2004, and the related statements of
operations, stockholders equity, and cash flows for each
of the three years in the period ended December 31, 2005.
These financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (U.S.). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of EPIX Pharmaceuticals, Inc. at December 31, 2005 and
2004, and the results of its operations and its cash flows for
each of the three years in the period ended December 31,
2005, in conformity with U.S. generally accepted accounting
principles.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (U.S.), the
effectiveness of EPIX Pharmaceuticals, Inc.s internal
control over financial reporting as of December 31, 2005,
based on criteria established in Internal Control-Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission and our report dated February 27,
2006 expressed an unqualified opinion thereon.
Boston, Massachusetts
February 27, 2006
F-2
EPIX PHARMACEUTICALS, INC.
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
72,502,906 |
|
|
$ |
73,364,538 |
|
|
Available-for-sale marketable securities
|
|
|
52,225,590 |
|
|
|
91,075,630 |
|
|
Accounts receivable
|
|
|
149,287 |
|
|
|
322,546 |
|
|
Prepaid expenses and other assets
|
|
|
346,919 |
|
|
|
585,138 |
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
125,224,702 |
|
|
|
165,347,852 |
|
Property and equipment, net
|
|
|
2,517,859 |
|
|
|
2,490,804 |
|
Other assets
|
|
|
2,973,155 |
|
|
|
3,448,270 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
130,715,716 |
|
|
$ |
171,286,926 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
1,268,325 |
|
|
$ |
938,498 |
|
|
Accrued expenses
|
|
|
4,310,003 |
|
|
|
4,218,834 |
|
|
Contract advances
|
|
|
6,112,549 |
|
|
|
6,150,013 |
|
|
Loan payable to strategic partner
|
|
|
|
|
|
|
15,000,000 |
|
|
Deferred revenue
|
|
|
435,861 |
|
|
|
2,387,882 |
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
12,126,738 |
|
|
|
28,695,227 |
|
Deferred revenue
|
|
|
755,647 |
|
|
|
1,209,725 |
|
Convertible debt
|
|
|
100,000,000 |
|
|
|
100,000,000 |
|
Commitments and Contigencies
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.01 par value, 1,000,000 shares
authorized; no shares issued
|
|
|
|
|
|
|
|
|
|
Common Stock, $0.01 par value, 40,000,000 shares
authorized; 23,284,810 and 23,190,154 shares issued and
outstanding at December 31, 2005 and 2004, respectively
|
|
|
232,848 |
|
|
|
231,900 |
|
|
Additional paid-in-capital
|
|
|
197,311,313 |
|
|
|
196,730,731 |
|
|
Accumulated deficit
|
|
|
(179,644,632 |
) |
|
|
(155,333,774 |
) |
|
Accumulated other comprehensive loss
|
|
|
(66,198 |
) |
|
|
(246,883 |
) |
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
17,833,331 |
|
|
|
41,381,974 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
130,715,716 |
|
|
$ |
171,286,926 |
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
EPIX PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product development revenue
|
|
$ |
4,195,530 |
|
|
$ |
7,594,280 |
|
|
$ |
9,534,335 |
|
|
Royalty revenue
|
|
|
2,333,384 |
|
|
|
626,685 |
|
|
|
2,397,393 |
|
|
License fee revenue
|
|
|
660,747 |
|
|
|
4,037,636 |
|
|
|
1,593,284 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
7,189,661 |
|
|
|
12,258,601 |
|
|
|
13,525,012 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
20,775,771 |
|
|
|
21,873,991 |
|
|
|
28,023,522 |
|
|
General and administrative
|
|
|
10,244,271 |
|
|
|
10,495,377 |
|
|
|
6,584,318 |
|
|
Restructuring costs
|
|
|
971,828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
31,991,870 |
|
|
|
32,369,368 |
|
|
|
34,607,840 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(24,802,209 |
) |
|
|
(20,110,767 |
) |
|
|
(21,082,828 |
) |
Interest income
|
|
|
4,146,532 |
|
|
|
1,958,152 |
|
|
|
663,519 |
|
Interest expense
|
|
|
(3,613,190 |
) |
|
|
(2,128,738 |
) |
|
|
(295,168 |
) |
|
|
|
|
|
|
|
|
|
|
Loss before provision for income taxes
|
|
|
(24,268,867 |
) |
|
|
(20,281,353 |
) |
|
|
(20,714,477 |
) |
Provision for income taxes
|
|
|
41,991 |
|
|
|
99,905 |
|
|
|
80,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(24,310,858 |
) |
|
$ |
(20,381,258 |
) |
|
$ |
(20,794,552 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
23,258,187 |
|
|
|
22,888,673 |
|
|
|
19,055,698 |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$ |
(1.05 |
) |
|
$ |
(0.89 |
) |
|
$ |
(1.09 |
) |
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
EPIX PHARMACEUTICALS, INC.
STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Total | |
|
|
Common Stock | |
|
|
|
|
|
Other | |
|
Stockholders | |
|
|
| |
|
Additional | |
|
Accumulated | |
|
Comprehensive | |
|
(Deficit) | |
|
|
Shares | |
|
Amount | |
|
Paid-In Capital | |
|
Deficit | |
|
Income/(loss) | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2002
|
|
|
17,074,034 |
|
|
$ |
170,740 |
|
|
$ |
119,712,094 |
|
|
$ |
(114,157,964 |
) |
|
$ |
161,645 |
|
|
$ |
5,886,515 |
|
Issuance of common stock upon exercise of options
|
|
|
573,737 |
|
|
|
5,738 |
|
|
|
3,488,632 |
|
|
|
|
|
|
|
|
|
|
|
3,494,370 |
|
Issuance of common stock under employee stock purchase plan
|
|
|
25,871 |
|
|
|
259 |
|
|
|
207,838 |
|
|
|
|
|
|
|
|
|
|
|
208,097 |
|
Issuance of common stock
|
|
|
4,645,000 |
|
|
|
46,450 |
|
|
|
65,443,384 |
|
|
|
|
|
|
|
|
|
|
|
65,489,834 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,794,552 |
) |
|
|
|
|
|
|
(20,794,552 |
) |
Available-for-sale marketable securities unrealized loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(127,692 |
) |
|
|
(127,692 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,922,244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
22,318,642 |
|
|
$ |
223,187 |
|
|
$ |
188,851,948 |
|
|
$ |
(134,952,516 |
) |
|
$ |
33,953 |
|
|
$ |
54,156,572 |
|
Issuance of common stock upon exercise of options
|
|
|
723,554 |
|
|
|
7,234 |
|
|
|
5,211,805 |
|
|
|
|
|
|
|
|
|
|
|
5,219,039 |
|
Issuance of common stock under employee stock purchase plan
|
|
|
15,958 |
|
|
|
159 |
|
|
|
231,950 |
|
|
|
|
|
|
|
|
|
|
|
232,109 |
|
Issuance of common stock
|
|
|
132,000 |
|
|
|
1,320 |
|
|
|
2,337,720 |
|
|
|
|
|
|
|
|
|
|
|
2,339,040 |
|
Compensatory stock option expense
|
|
|
|
|
|
|
|
|
|
|
97,308 |
|
|
|
|
|
|
|
|
|
|
|
97,308 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,381,258 |
) |
|
|
|
|
|
|
(20,381,258 |
) |
Available-for-sale marketable securities unrealized loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(280,836 |
) |
|
|
(280,836 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,662,094 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
23,190,154 |
|
|
$ |
231,900 |
|
|
$ |
196,730,731 |
|
|
$ |
(155,333,774 |
) |
|
$ |
(246,883 |
) |
|
$ |
41,381,974 |
|
Issuance of common stock upon exercise of options
|
|
|
75,498 |
|
|
|
756 |
|
|
|
473,359 |
|
|
|
|
|
|
|
|
|
|
|
474,115 |
|
Issuance of common stock under employee stock purchase plan
|
|
|
19,158 |
|
|
|
192 |
|
|
|
103,804 |
|
|
|
|
|
|
|
|
|
|
|
103,996 |
|
Compensatory stock option expense
|
|
|
|
|
|
|
|
|
|
|
3,419 |
|
|
|
|
|
|
|
|
|
|
|
3,419 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,310,858 |
) |
|
|
|
|
|
|
(24,310,858 |
) |
Available-for-sale marketable securities unrealized gain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
180,685 |
|
|
|
180,685 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,130,173 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
23,284,810 |
|
|
$ |
232,848 |
|
|
$ |
197,311,313 |
|
|
$ |
(179,644,632 |
) |
|
$ |
(66,198 |
) |
|
$ |
17,833,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
EPIX PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(24,310,858 |
) |
|
$ |
(20,381,258 |
) |
|
$ |
(20,794,552 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
1,188,610 |
|
|
|
1,000,101 |
|
|
|
638,282 |
|
|
Stock compensation expense
|
|
|
3,419 |
|
|
|
97,308 |
|
|
|
|
|
|
Amortization of deferred financing costs
|
|
|
475,115 |
|
|
|
260,188 |
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
173,259 |
|
|
|
(276,474 |
) |
|
|
129,060 |
|
|
Prepaid expenses and other current assets
|
|
|
238,219 |
|
|
|
(191,459 |
) |
|
|
122,520 |
|
|
Other assets
|
|
|
|
|
|
|
4,943 |
|
|
|
(4,313 |
) |
|
Accounts payable
|
|
|
329,827 |
|
|
|
(999,867 |
) |
|
|
43,804 |
|
|
Accrued expenses
|
|
|
91,169 |
|
|
|
(1,300,985 |
) |
|
|
1,454,932 |
|
|
Accrued reacquisition costs
|
|
|
|
|
|
|
|
|
|
|
(2,400,000 |
) |
|
Contract advances
|
|
|
(37,464 |
) |
|
|
2,977,306 |
|
|
|
40,636 |
|
|
Deferred revenue
|
|
|
(2,406,099 |
) |
|
|
(3,650,620 |
) |
|
|
(3,189,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(24,254,803 |
) |
|
|
(22,460,817 |
) |
|
|
(23,959,560 |
) |
Investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of marketable securities
|
|
|
(88,618,059 |
) |
|
|
(93,663,936 |
) |
|
|
(43,344,575 |
) |
|
Sale or redemption of marketable securities
|
|
|
127,648,784 |
|
|
|
45,607,145 |
|
|
|
23,488,773 |
|
|
Purchases of fixed assets
|
|
|
(1,215,665 |
) |
|
|
(2,077,559 |
) |
|
|
(758,826 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
37,815,060 |
|
|
|
(50,134,350 |
) |
|
|
(20,614,628 |
) |
Financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of convertible debt
|
|
|
|
|
|
|
96,350,000 |
|
|
|
|
|
|
Proceeds from loan payable from strategic partner
|
|
|
45,000,000 |
|
|
|
52,500,000 |
|
|
|
15,000,000 |
|
|
Repayment of loan payable to strategic partner
|
|
|
(60,000,000 |
) |
|
|
(45,000,000 |
) |
|
|
(7,500,000 |
) |
|
Proceeds from stock options
|
|
|
474,115 |
|
|
|
5,219,039 |
|
|
|
3,494,370 |
|
|
Proceeds from Employee Stock Purchase Plan
|
|
|
103,996 |
|
|
|
232,109 |
|
|
|
208,097 |
|
|
Proceeds from sale of common stock
|
|
|
|
|
|
|
|
|
|
|
65,489,834 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
(14,421,889 |
) |
|
|
109,301,148 |
|
|
|
76,692,301 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(861,632 |
) |
|
|
36,705,981 |
|
|
|
32,118,113 |
|
Cash and cash equivalents at beginning of period
|
|
|
73,364,538 |
|
|
|
36,658,557 |
|
|
|
4,540,444 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$ |
72,502,906 |
|
|
$ |
73,364,538 |
|
|
$ |
36,658,557 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
3,145,883 |
|
|
$ |
1,747,236 |
|
|
$ |
329,982 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for taxes
|
|
$ |
41,991 |
|
|
$ |
107,889 |
|
|
$ |
99,655 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of noncash financing and investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in connection with Intellectual
Property Agreement
|
|
$ |
|
|
|
$ |
2,339,040 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-6
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005
EPIX Pharmaceuticals, Inc. (EPIX or the
Company), formerly known as EPIX Medical, Inc., was
formed in 1988 and commenced operations in 1992. The Company
discovers and develops innovative pharmaceuticals for imaging
that are designed to transform the diagnosis, treatment and
monitoring of disease. The Company uses its proprietary Target
Visualization
Technologytm
to create imaging agents targeted at the molecular level. These
agents are designed to enable physicians to use magnetic
resonance imaging (MRI) to obtain detailed
information about specific disease processes. MRI has been
established as the imaging technology of choice for a broad
range of applications, including the identification and
diagnosis of a variety of medical disorders. MRI is safe,
relatively cost-effective and provides three-dimensional images
that enable physicians to diagnose and manage disease in a
minimally invasive manner.
The Company is currently developing two products for use in MRI
to improve the diagnosis of multiple diseases affecting the
bodys arteries and veins, collectively known as the
vascular system: Vasovist, the Companys novel blood-pool
contrast agent for use in magnetic resonance angiography, which
was approved for marketing in all 25 member states of the E.U.
in October 2005; and EP-2104R for detecting human thrombus, or
blood clots, using MRI. The Company has entered into various
partnership agreements with Schering AG with respect to both
Vasovist and EP-2104R.
The Company is also actively seeking to acquire a privately-held
therapeutics company with the goal of becoming a specialty
pharmaceutical company.
|
|
2. |
Significant Accounting Policies |
The Company considers investments with an original maturity of
three months or less when purchased to be cash equivalents. Cash
equivalents consist of money market accounts, commercial paper
and federal agency obligations.
The Company accounts for marketable securities in accordance
with Statement of Financial Accounting Standards
(SFAS) No. 115, Accounting for Certain
Investments in Debt and Equity Securities
(SFAS 115). SFAS 115 establishes the
accounting and reporting requirements for all debt securities
and for investments in equity securities that have readily
determinable fair values. Marketable securities consist of
investment-grade corporate bonds, asset-backed debt securities
and government-sponsored agency debt securities. The Company
classifies its marketable securities as available-for-sale and,
as such, carries the investments at fair value, with unrealized
holding gains and losses included in accumulated other
comprehensive income or loss. The cost of debt securities is
adjusted for amortization of premiums and accretion of discounts
to maturity. Such amortization and accretion are included in
interest income. Realized gains or losses and declines in value
judged to be other-than-temporary on available-for-sale
securities are included in interest income. The cost of
securities is based on the specific identification method.
|
|
|
Fair Value of Financial Instruments |
At December 31, 2005 and 2004, the Companys financial
instruments consisted of cash and cash equivalents,
available-for-sale marketable securities and debt. The carrying
value of cash equivalents and the loan payable to strategic
partner approximates fair value due to their short-term nature.
The carrying value of the available-for-sale marketable
securities and convertible debt is further discussed in
Notes 2
F-7
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
and 7, respectively. The fair value of the
3.0% convertible senior notes, which is based on quoted
market prices, was approximately $65.0 million at
December 31, 2005.
|
|
|
Concentrations of Credit Risk |
Financial instruments that potentially subject the Company to
concentrations of credit risk primarily consist of cash
equivalents, available-for-sale marketable securities and
accounts receivable. In accordance with the Companys
investment policy, marketable securities are principally
restricted to U.S. government securities, high-grade bank
obligations, high-grade corporate bonds, commercial paper and
certain money market funds. Although the Company had
$124.7 million of cash, cash equivalents and
available-for-sale marketable securities invested through two
investment advisors as of December 31, 2005, the credit
risk exposure of its investments was limited because of a
diversified portfolio that included debt of various
government-sponsored enterprises, such as Federal National
Mortgage Association, Federal Farm Credit Bank Federal Home Loan
Mortgage Corporation and the Federal Home Loan Bank;
high-grade corporate bonds and commercial paper; certificates of
deposit and money market funds.
The Company performs ongoing credit evaluations of its
collaborators financial condition, but does not require
collateral. The Company continuously monitors collections from
collaborators. Historically, the Company has not experienced
losses related to its accounts receivable. If the financial
condition of its collaborators were to deteriorate, resulting in
an impairment of their ability to make payments, the
establishment of an allowance may be required.
Property and equipment are recorded at historical cost.
Depreciation on laboratory equipment, furniture and fixtures and
other equipment is determined using the straight-line method
over the estimated useful lives of the related assets, ranging
from 2 to 5 years. Leasehold improvements are amortized
using the straight-line method over the shorter of the asset
life or the remaining life of the lease. Expenditures for
maintenance and repairs are charged to expense as incurred;
improvements which extend the life or use of equipment are
capitalized.
In accordance with SFAS No. 144, Accounting
for the Impairment or Disposal of Long-Lived Assets,
the Company recognizes impairment losses on long-lived
assets when indicators of impairment are present and future
undiscounted cash flows are insufficient to support the
assets recovery.
The Company provides for income taxes under
SFAS No. 109, Accounting for Income
Taxes. Under this method, deferred taxes are
recognized using the liability method, whereby tax rates are
applied to cumulative temporary differences between carrying
amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes are based
on when and how they are expected to affect the tax return. A
valuation allowance is provided to the extent that there is
uncertainty as to the Companys ability to generate
sufficient taxable income in the future to realize the benefit
from its net deferred tax asset.
SFAS No. 131, Disclosure about Segments of an
Enterprise and Related Information, establishes
standards for reporting information regarding operating segments
and for related disclosures about products
F-8
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
and services and geographical areas. The Company operates in one
business segment, which is the development of targeted contrast
agents.
For the years ended December 31, 2005, 2004 and 2003,
Schering AG represented 63%, 64% and 74%, respectively, of total
revenues and Bracco represented 36%, 33% and 21%, respectively,
of total revenues.
|
|
|
Product development revenue |
In June 2000, the Company entered into a strategic collaboration
agreement with Schering AG, whereby each party to the agreement
shares equally in Vasovist development costs and
U.S. operating profits and the Company will receive
royalties related to
non-U.S. sales.
The Company recognizes product development revenue at the time
it performs research and development activities for which
Schering and other collaborators are obligated to reimburse the
Company. Product development revenues from Schering are recorded
net of the Companys portion of Schering AGs actual
or most recent estimate of its Vasovist research and development
costs.
In May 2003, the Company entered into a development agreement
with Schering AG for EP-2104R and a collaboration agreement with
Schering AG for MRI research as described in Note 12. Under
the EP-2104R development agreement, Schering AG agreed to make
fixed payments totaling approximately $9.0 million over two
years to the Company, which began in the second quarter of 2003
and ended in the fourth quarter of 2004, to cover a portion of
the Companys expenditures in the feasibility program. The
Company recognizes revenue from Schering AG for the EP-2104R
feasibility program in proportion to actual cost incurred
relative to the estimated total program costs. As estimated
total cost to complete a program increases, revenue is adjusted
downwards, and conversely, as estimated cost to complete
decreases, revenue is adjusted upwards. Total estimated costs of
the feasibility program are based on managements
assessment of costs to complete the program based upon an
evaluation of the portion of the program completed, costs
incurred to date and expected future costs of the program. To
the extent that estimated costs to complete the feasibility
program change materially from the previous periods, adjustments
to revenue are recorded. In 2003, management increased its
EP-2104R estimate to complete the feasibility program from its
original estimate of $9.0 million to $11.2 million,
resulting in a reduction in product development revenue of
$818,793 in 2003. As of December 2004, management had increased
its EP-2104R estimate to complete the feasibility program to
$13.2 million, resulting in a further reduction in product
development revenue of $1.2 million in 2004, of which
$853,138 was recognized in the fourth quarter of 2004. During
the second quarter of 2005, the Company increased the estimated
cost to complete the feasibility program to $16.1 million
from its prior estimate. The increase in the cost to complete
the feasibility program was primarily attributed to the
additional patient safety monitoring related to amending the
Phase II
proof-of-concept
clinical trial protocols for EP-2104R announced in July 2005.
The impact of increasing the estimated cost to complete the
feasibility program resulted in a reduction in product
development revenue of $1.5 million during the same period.
During the fourth quarter of 2005, the Company lowered the
estimate of the cost to complete the feasibility program from
$16.1 million to $15.2 million at December 31,
2005 as a result of the increased enrollment rate for this
clinical trial. This latest reduction in the estimated total
cost of the feasibility program resulted in an increase in
product development revenue of $449,944, which was recognized in
the fourth quarter of 2005. Revenue under the MRI research
collaboration is recognized at the time services are provided
and for which Schering AG is obligated to reimburse the Company.
Payments received by the Company from Schering AG in advance of
EPIX performing research and development activities are recorded
as contract advances.
F-9
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The Company earns royalty revenue pursuant to its sub-license on
certain of its patents to Bracco Imaging S.p.A.
(Bracco). Royalty revenue is recognized based on
actual revenues as reported by Bracco to the Company. Prior to
the fourth quarter of 2004, the Company recognized royalty
revenue based on royalty reports received from Bracco or on
Braccos estimates, historical revenues and trends when
royalty reports from Bracco were not available in a timely
manner. In December 2004, Bracco notified the Company that it
had overstated
non-U.S. royalties
to the Company for the period 2001 to 2004, and that Bracco
would offset the amount of the overstatement against its
payments to the Company, including those triggered by FDA
approval of
MultiHance®
in the U.S. Although the Company is disputing Braccos
assertion regarding the overstatement, the Company recognized
the impact of Braccos claimed overstatement by reducing
its 2004 royalty revenue. In addition, because the Company no
longer believes that it has a reasonable basis to make royalty
estimates under the agreement with Bracco, it has, commencing in
the fourth quarter of 2004, only recognized royalties from
Bracco in the period in which royalty reports are received.
In connection with the execution of the sub-licensing
arrangement in September 2001, Bracco made a $4.0 million
refundable advance royalty payment to the Company, which was
accounted for as deferred revenue. When royalty revenue is
earned, a portion of the royalty revenue earned is offset
against the $4.0 million refundable advance royalty. The
deferred revenue balance was fully earned at December 31,
2005 and was $1.7 million at December 31, 2004.
Massachusetts General Hospital (MGH) owns the
patents and has exclusively licensed those patents to the
Company, which has in turn sub-licensed the patents to Bracco.
The Company owes MGH a percentage of all royalties received from
its sub-licenses. Royalties paid to MGH, totaled $31,354,
$128,801 and $90,453 for the years ended December 31, 2005,
2004 and 2003, respectively.
The Company records license fee revenues in accordance with SEC
Staff Accounting Bulletin No. 104, Revenue
Recognition (SAB 104). Pursuant to
SAB 104, the Company recognizes revenues from
non-refundable license fees and milestone payments, not
specifically tied to a separate earnings process, ratably over
the period during which the Company has a substantial continuing
obligation to perform services under the contract. When
milestone payments are specifically tied to a separate earnings
process, revenue is recognized when the specific performance
obligations associated with the payment are completed.
In September 2001, the Company sub-licensed certain patents to
Bracco and received a $2.0 million license fee from Bracco.
This license fee is included in deferred revenue and is being
recorded as revenue ratably from the time of the payment until
the expiration of MGHs patent in 2006.
As part of the strategic collaboration agreement the Company
entered into with Schering AG in 2000, the Company granted
Schering AG an exclusive license to co-develop and market
Vasovist worldwide, exclusive of Japan. Later in 2000, the
Company amended this strategic collaboration agreement to grant
Schering AG exclusive rights to develop and market Vasovist in
Japan, with the Company receiving a $3.0 million license
fee from Schering AG. This license fee was included in deferred
revenue and is being recorded as revenue ratably from the time
of the payment until anticipated approval in Japan. The Company
will continue to review this estimate and make appropriate
adjustments as information becomes available.
Pursuant to a collaboration agreement with Mallinckrodt, Inc, a
subsidiary of Tyco/ Mallinckrodt, the Company recorded
$4.4 million of deferred revenue that is being recorded as
revenue ratably from the
F-10
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
time of payment until anticipated approval of Vasovist in the
U.S. The Company will continue to review this estimate and
make appropriate adjustments as information becomes available.
Certain amounts in the accompanying financial statement have
been reclassified to conform to the current year presentation.
The preparation of financial statements in conformity with
accounting principles generally accepted in the
U.S. requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could
differ from those estimates.
|
|
|
Research and Development Expenses |
Research and development costs, including those associated with
technology, licenses and patents, are expensed as incurred.
Research and development costs primarily include employee
salaries and related costs, third party service costs, the cost
of preclinical and clinical trial supplies and consulting
expenses.
In order to conduct research and development activities and
compile regulatory submissions, the Company enters into
contracts with vendors who render services over an extended
period of time, generally one to three years. Typically, the
Company enters into three types of vendor contracts; time-based,
patient-based or a combination thereof. Under a time-based
contract, using critical factors contained within the contract,
usually the stated duration of the contract and the timing of
services provided, the Company records the contractual expense
for each service provided under the contract ratably over the
period during which it estimates the service will be performed.
Under a patient-based contract, the Company first determines an
appropriate per patient cost using critical factors contained
within the contract, which include the estimated number of
patients and the total dollar value of the contract. The Company
then records expense based upon the total number of patients
enrolled during the period. On a quarterly basis, the Company
reviews both the timetable of services to be rendered and the
timing of services actually received. Based upon this review,
revisions may be made to the forecasted timetable or the extent
of services performed, or both, in order to reflect the
Companys most current estimate of the contract.
The Company computes loss per share in accordance with the
provisions of SFAS No. 128, Earnings per
Share. Basic net loss per share is based upon the
weighted-average number of common shares outstanding and
excludes the effect of dilutive common stock issuable upon
exercise of stock options and convertible debt. Diluted net loss
per share includes the effect of dilutive common stock issuable
upon exercise of stock options and convertible debt using the
treasury stock method. In computing diluted loss per share, only
potential common shares that are dilutive, or those that reduce
earnings per share, are included. The exercise of options or
convertible debt is not assumed if the result is anti-dilutive,
such as when a loss is reported.
In June 2004, the Company completed a sale, pursuant to
Rule 144A under the Securities Act of 1933, of
$100.0 million of 3% convertible senior notes due 2024
for net proceeds of approximately $96.4 million. Each
$1,000 of senior notes is convertible into 33.5909 shares
of the Companys common stock representing a conversion
price of approximately $29.77 per share if (1) the
price of the Companys common stock trades above 120% of
the conversion price for a specified time period, (2) the
trading price
F-11
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
of the senior notes is below a certain threshold, (3) the
senior notes have been called for redemption, or
(4) specified corporate transactions have occurred. None of
these conversion triggers has occurred as of December 31,
2005.
Common stock potentially issuable but excluded from the
calculation of dilutive net loss per share for the years ended
December 31, 2005, 2004 and 2003 because their inclusion
would have been antidilutive consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Stock options and awards
|
|
|
3,271,909 |
|
|
|
3,560,478 |
|
|
|
3,557,499 |
|
Shares issuable on conversion of 3% Convertible Senior Notes
|
|
|
3,359,090 |
|
|
|
3,359,090 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,630,999 |
|
|
|
6,919,568 |
|
|
|
3,557,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Income (Loss) |
In accordance with SFAS No. 130, Reporting
Comprehensive Income (SFAS 130),
components of comprehensive income include net income and
certain transactions that have generally been reported in the
statements of stockholders equity. Other comprehensive
income is comprised of unrealized gains or losses on
available-for-sale marketable securities.
|
|
|
Employee Stock Compensation |
The Company has elected to follow Accounting Principles Board
Opinion No. 25, Accounting for Stock Issued to
Employees (APB 25) in accounting for
its stock-based compensation plans under the intrinsic value
method, rather than the alternative fair value accounting method
provided for under SFAS No. 123, Accounting
for Stock-Based Compensation
(SFAS 123). Under APB 25, because the
exercise price of the Companys employee stock options
equals the market price of the underlying stock on the date of
grant, no compensation expense is recognized.
The following table illustrates the effect on net loss and net
loss per share if the Company had applied the fair value
recognition provisions of SFAS 123 to stock-based employee
compensation.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Net loss as reported
|
|
$ |
(24,310,858 |
) |
|
$ |
(20,381,258 |
) |
|
$ |
(20,794,552 |
) |
|
Less: employee stock-based compensation included in net loss as
reported
|
|
|
|
|
|
|
97,308 |
|
|
|
|
|
|
Add: pro forma adjustment for stock-based compensation
|
|
|
(4,141,790 |
) |
|
|
(6,047,438 |
) |
|
|
(4,040,572 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss pro forma
|
|
$ |
(28,452,648 |
) |
|
$ |
(26,331,388 |
) |
|
$ |
(24,835,124 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported
|
|
$ |
(1.05 |
) |
|
$ |
(0.89 |
) |
|
$ |
(1.09 |
) |
|
Pro forma
|
|
|
(1.22 |
) |
|
|
(1.15 |
) |
|
|
(1.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
Effect of pro form adjustment
|
|
$ |
(0.18 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
F-12
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The weighted-average grant date fair value of stock options
granted during 2005, 2004 and 2003 was $5.56, $15.66 and
$6.43 per share, respectively, on the date of grant using
the Black-Scholes option pricing model with the following
weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options | |
|
ESPP | |
|
|
| |
|
| |
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Expected life of option (years)
|
|
|
6.9 |
|
|
|
7.3 |
|
|
|
6.6 |
|
|
|
0.5 |
|
|
|
0.5 |
|
|
|
0.5 |
|
Expected stock price volatility
|
|
|
0.83 |
|
|
|
0.85 |
|
|
|
0.87 |
|
|
|
0.82 |
|
|
|
0.84 |
|
|
|
0.86 |
|
Weighted average risk-free interest rate
|
|
|
3.77 |
% |
|
|
3.25 |
% |
|
|
3.27 |
% |
|
|
3.51 |
% |
|
|
1.40 |
% |
|
|
1.12 |
% |
The effects on 2005, 2004 and 2003 pro forma net loss and net
loss per share of expensing the estimated fair value of stock
options and common shares issued pursuant to the stock option
and stock purchase plans are not necessarily representative of
the effects on reported results of operations for future years
as options vest over several years.
|
|
|
Recent Accounting Pronouncements |
In December 2004, the Financial Accounting Standards Board
(FASB) issued revised SFAS No. 123,
Share-Based Payment An Amendment of FASB
Statements No. 123 and 95,
(SFAS 123R). SFAS 123R supersedes
APB 25, and amends SFAS No. 95,
Statement of Cash Flows. Generally, the
approach in SFAS 123R is similar to the approach described
in SFAS 123. However, SFAS 123R requires all
share-based payments to employees, including grants of employee
stock options, to be recognized in the income statement based on
their fair values. Pro forma disclosure is no longer permitted.
The Company is required to adopt SFAS 123R beginning on
January 1, 2006.
SFAS 123R permits public companies to adopt its
requirements using one of two methods: (i) the
modified prospective method in which compensation
cost is recognized beginning with the effective date
(a) based on the requirements of SFAS 123R for all
share-based payments granted after the effective date and
(b) based on the requirements of SFAS 123R for all
awards granted to employees prior to the effective date of
SFAS 123R that remain unvested on the effective date; or
the modified retrospective method which includes the
requirements of the modified prospective method described above,
but also permits entities to restate based on the amounts
previously recognized under SFAS 123 for purposes of
pro forma disclosures either (a) all prior periods
presented or (b) prior interim periods of the year of
adoption. The Company will be adopting the modified
prospective method when applying SFAS 123R.
As permitted by SFAS 123R, the Company currently accounts
for share-based payments to employees using APB 25s
intrinsic value method and, as such, generally recognizes no
compensation cost for employee stock options. Accordingly, the
adoption of SFAS 123Rs fair value method will have a
significant impact on the Companys results of operations,
although it will have no impact on its overall financial
position. The impact of adoption of SFAS 123R cannot be
predicted at this time because it will depend on levels of
share-based payments granted in the future. However, had the
Company adopted SFAS 123R in prior periods, the impact of
that standard would have approximated the impact of
SFAS 123 as described in the disclosure of pro forma net
loss and net loss per share discussed above.
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections,
(SFAS 154), a replacement of APB No. 20,
Accounting Changes, and SFAS No. 3,
Reporting Accounting Changes in Interim Financial
Statements, (SFAS 3). SFAS 154
replaces the provisions of SFAS 3 with respect to reporting
accounting changes in interim financial statements.
SFAS 154 is effective for accounting changes and
corrections of errors made in fiscal years beginning after
December 15, 2005. Early adoption is permitted for
accounting changes and corrections of errors made in
F-13
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
fiscal years beginning after June 1, 2005. The Company does
not believe the adoption of SFAS 154 will have a material
impact on its overall financial position or results of
operations.
The estimated fair value of marketable securities is determined
based on broker quotes or quoted market prices or rates for the
same or similar instruments. The estimated fair value and cost
of marketable securities are as follows at December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
Fair Value | |
|
Cost | |
|
Fair Value | |
|
Cost | |
|
|
| |
|
| |
|
| |
|
| |
Government-sponsored agency securities
|
|
$ |
19,559,610 |
|
|
$ |
19,584,572 |
|
|
$ |
38,237,366 |
|
|
$ |
38,364,954 |
|
Corporate bonds
|
|
|
25,112,035 |
|
|
|
25,153,272 |
|
|
|
38,506,427 |
|
|
|
38,625,721 |
|
Commercial paper
|
|
|
3,980,788 |
|
|
|
3,980,787 |
|
|
|
3,991,800 |
|
|
|
3,991,800 |
|
Certificates of deposit
|
|
|
3,573,157 |
|
|
|
3,573,157 |
|
|
|
10,340,037 |
|
|
|
10,340,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
52,225,590 |
|
|
$ |
52,291,788 |
|
|
$ |
91,075,630 |
|
|
$ |
91,322,512 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturities of marketable securities classified as
available-for-sale by contractual maturity are shown below:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Due within one year
|
|
$ |
48,447,012 |
|
|
$ |
47,193,349 |
|
Due after one year through two years
|
|
|
3,778,578 |
|
|
|
43,882,281 |
|
|
|
|
|
|
|
|
|
|
$ |
52,225,590 |
|
|
$ |
91,075,630 |
|
|
|
|
|
|
|
|
Gross unrealized gains on marketable securities amounted to
$2,678 and $2,799 in 2005 and 2004, respectively. Gross
unrealized losses on marketable securities amounted to $68,876
and $249,681 in 2005 and 2004, respectively. The aggregate fair
value of investments with unrealized losses was
$36.4 million and $76.7 million at December 31,
2005 and 2004, respectively. All such investments have been in
an unrealized loss position for less than one year, except for a
small number of government-sponsored agency securities that had
a cumulative unrealized loss of $14,132 and $1,764 at
December 31, 2005 and 2004, respectively. The aggregate
fair value of investments that have been in an unrealized loss
position for a year or greater were $3.8 million and
$775,044 at December 31, 2005 and 2004, respectively. The
Company has reviewed those investments based on a number of
factors, including the reasons for the impairment, compliance
with the Companys investment policy, the severity and
duration of the impairment and the changes in value subsequent
to year end, and has concluded that no other-than-temporary
impairment existed as of December 31, 2005 and 2004.
There were no realized gains or losses on marketable securities
in 2005 and 2004.
F-14
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
|
|
4. |
Property and Equipment |
Property and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Leasehold improvements
|
|
$ |
3,880,443 |
|
|
$ |
3,607,588 |
|
Laboratory equipment
|
|
|
2,669,880 |
|
|
|
3,568,169 |
|
Furniture, fixtures and other equipment
|
|
|
1,052,703 |
|
|
|
1,716,801 |
|
|
|
|
|
|
|
|
|
|
|
7,603,026 |
|
|
|
8,892,558 |
|
Less accumulated depreciation and amortization
|
|
|
(5,085,167 |
) |
|
|
(6,401,754 |
) |
|
|
|
|
|
|
|
|
|
$ |
2,517,859 |
|
|
$ |
2,490,804 |
|
|
|
|
|
|
|
|
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Accrued contractual product development expenses
|
|
$ |
1,680,790 |
|
|
$ |
2,330,849 |
|
Accrued compensation
|
|
|
1,768,330 |
|
|
|
969,925 |
|
Other accrued expenses
|
|
|
860,883 |
|
|
|
918,060 |
|
|
|
|
|
|
|
|
|
|
$ |
4,310,003 |
|
|
$ |
4,218,834 |
|
|
|
|
|
|
|
|
During the fourth quarter of 2005 the Company incurred a
restructuring charge related to planned actions that were taken
by management to control costs and improve the focus of its
operations in order to reduce losses and conserve cash. The
Company announced a planned reduction in its workforce by
48 employees, or approximately 50%, in response to the
FDAs second approvable letter regarding Vasovist. The
reductions, which were completed in January 2006, affected both
the research and development and the general and administrative
areas of the Company. The Company reported a charge of $971,828
for severance and related benefits as of December 31, 2005.
Substantially all payments related to the separation of
employment will be completed in the first quarter of 2006.
The Company also expects to incur additional restructuring
expenses in 2006 related to facility consolidation and possible
sales of assets. The charge for additional restructuring
expenses will be recognized when such actions occur. At this
time the Company is not able to estimate the amount of
additional restructuring expenses.
|
|
7. |
Financing Arrangements |
|
|
|
Loan Payable to Strategic Partner |
In May 2003, the Company entered into a Non-Negotiable Note and
Security Agreement (the Loan Agreement) with
Schering AG under which the Company is eligible to borrow up to
a total of $15.0 million. The Loan Agreement carries a
variable, market-based interest rate, which was 11.25% and 9.25%
at December 31, 2005 and 2004, respectively. The entire
$15.0 million amount under the Loan Agreement was available
as of December 31, 2005, but was not drawn down by the
Company. At
F-15
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
December 31, 2004, $15 million was outstanding under
the Loan Agreement, which was repaid in January 2005. In January
2006, the Company and Schering AG agreed to terminate the Loan
Agreement.
In June 2004, the Company completed a sale, pursuant to
Rule 144A under the Securities Act of 1933, of
$100 million of 3% convertible senior notes due 2024
for net proceeds of approximately $96.4 million. Each
$1,000 of senior notes is convertible into 33.5909 shares
of the Companys common stock representing a conversion
price of approximately $29.77 per share if (1) the
price of the Companys common stock trades above 120% of
the conversion price for a specified time period, (2) the
trading price of the senior notes is below a certain threshold,
(3) the senior notes have been called for redemption, or
(4) specified corporate transactions have occurred. None of
these conversion triggers has occurred as of December 31,
2005. Each of the senior notes is also convertible into the
Companys common stock in certain other circumstances. The
senior notes bear an interest rate of 3%, payable semiannually
on June 15 and December 15, beginning on December 15,
2004. Interest payments of $3.0 million and
$1.6 million were made during the years ended
December 31, 2005 and 2004, respectively. The senior notes
are unsecured and are subordinated to secured debt, including
the loan payable to Schering AG.
The Company has the right to redeem the notes on or after
June 15, 2009 at an initial redemption price of 100.85%,
plus accrued and unpaid interest. Noteholders may require the
Company to repurchase the notes at par, plus accrued and unpaid
interest, on June 15, 2011, 2014 and 2019 and upon certain
other events, including change of control and termination of
trading.
In connection with the issuance of the senior notes, the Company
incurred $3.65 million of issuance costs, which primarily
consisted of investment banker fees and legal and other
professional fees. The costs are being amortized as interest
expense using the effective interest method over the term from
issuance through the first date that the holders are entitled to
require repurchase of the senior notes (June 2011). For the
years ended December 31, 2005 and 2004, amortization of the
issuance costs was $475,115 and $260,188, respectively.
The Company leases office and laboratory space and certain
office equipment under operating lease arrangements. The
Companys office and laboratory space leases expire in
December 2007.
Future minimum commitments under leases with non-cancelable
terms of one or more years are as follows at December 31,
2005:
|
|
|
|
|
2006
|
|
$ |
1,303,059 |
|
2007
|
|
|
1,319,753 |
|
2008
|
|
|
5,184 |
|
|
|
|
|
Total minimum lease payments
|
|
$ |
2,627,996 |
|
|
|
|
|
Total rental expense amounted to $1,292,157, $1,194,586 and
$1,573,643 for 2005, 2004 and 2003, respectively.
In January 2002, the Company raised $30.1 million, net of
underwriter discounts, commissions and expenses, through the
issuance and sale of 2.575 million shares of its common
stock pursuant to its effective shelf registration statement,
previously filed with the SEC. In August 2003, the Company raised
F-16
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
$65.5 million, net of underwriter discounts, commissions
and expenses, through the issuance and sale of
4.645 million shares of its common stock pursuant to its
effective shelf registration statement.
The Company has in place an Amended and Restated 1992 Equity
Incentive Plan (the Equity Plan), which provides
stock awards to purchase shares of common stock to be granted to
employees and consultants. In June 2005, the Company amended the
Equity Plan to increase the number of shares reserved for
issuance pursuant to future grants by 500,000. The Equity Plan
provides for the grant of stock options (incentive and
non-statutory), stock appreciation rights, performance shares,
restricted stock or stock units, for the purchase of an
aggregate of 7,099,901 shares of common stock since the
Equity Plans inception, subject to adjustment for
stock-splits and similar capital changes. Awards under the
Equity Plan may be granted to officers, employees and other
individuals as determined by the Compensation Committee. The
Compensation Committee also selects the participants and
establishes the terms and conditions of each option or other
equity right granted under the Equity Plan, including the
exercise price, the number of shares subject to options or other
equity rights and the time at which such options become
exercisable. The stock options have a contractual term of ten
years and generally vest over a period of five years. As of
December 31, 2005, 4,379,656 shares of common stock
are reserved for issuance under the Equity Plan. Since the
inception of the Equity Plan, options to
purchase 2,720,245 shares of common stock have been
exercised.
Stock option information relating to the Equity Plan is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Exercisable | |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
Weighted | |
|
|
Options | |
|
Option Price | |
|
Average | |
|
Available | |
|
|
|
Average | |
|
|
Outstanding | |
|
Range per Share | |
|
Exercise Price | |
|
for Grant | |
|
Number | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
December 31, 2002
|
|
|
3,671,734 |
|
|
$ |
0.42 - $21.63 |
|
|
$ |
8.64 |
|
|
|
580,711 |
|
|
|
1,450,742 |
|
|
$ |
7.65 |
|
Granted
|
|
|
643,588 |
|
|
$ |
6.36 - $19.87 |
|
|
$ |
8.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(573,737 |
) |
|
$ |
0.42 - $15.38 |
|
|
$ |
6.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(339,086 |
) |
|
$ |
5.13 - $19.40 |
|
|
$ |
9.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003
|
|
|
3,402,499 |
|
|
$ |
0.45 - $21.63 |
|
|
$ |
8.90 |
|
|
|
776,209 |
|
|
|
1,365,079 |
|
|
$ |
8.76 |
|
Granted
|
|
|
944,430 |
|
|
$ |
15.50 - $25.37 |
|
|
$ |
20.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(723,554 |
) |
|
$ |
0.45 - $16.50 |
|
|
$ |
7.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(302,897 |
) |
|
$ |
5.13 - $21.54 |
|
|
$ |
10.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004
|
|
|
3,320,478 |
|
|
$ |
0.83 - $25.37 |
|
|
$ |
12.25 |
|
|
|
634,676 |
|
|
|
1,273,690 |
|
|
$ |
9.76 |
|
Granted
|
|
|
594,255 |
|
|
$ |
6.35 - $17.39 |
|
|
$ |
7.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(75,498 |
) |
|
$ |
0.83 - $ 9.13 |
|
|
$ |
6.28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(830,660 |
) |
|
$ |
5.13 - $25.37 |
|
|
$ |
12.74 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005
|
|
|
3,008,575 |
|
|
$ |
4.48 - $24.72 |
|
|
$ |
11.29 |
|
|
|
1,371,081 |
|
|
|
1,634,890 |
|
|
$ |
10.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1996 Director Stock Option Plan |
The Company has in place an Amended and Restated
1996 Director Stock Option Plan (the Director
Plan). All of the directors who are not employees of the
Company are currently eligible to participate in the Director
Plan. In June 2005, the Company amended the Director Plan to
increase the number of shares reserved for issuance pursuant to
future grants by 100,000. The number of shares
F-17
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
underlying the option granted to each eligible director upon
election or re-election is 25,000 shares. Each option
becomes exercisable with respect to 8,333 shares on each
anniversary date of grant for a period of three years, provided
that the option holder is still a director of the Company at the
opening of business on such date. In addition, each eligible
director is automatically granted an option to
purchase 5,000 shares annually during the years in
which such director is not up for reelection. Such options
become exercisable in full on the first anniversary date of the
grant, provided the option holder is still a director of the
Company at the opening of business on such date. The term of
each option granted under the Director Plan is ten years from
the date of grant. The exercise price for the options is equal
to the fair value of the underlying shares at the date of grant.
As of December 31, 2005, 394,668 shares of common
stock are reserved for issuance under the Director Plan. Since
the inception of the Director Plan, options to
purchase 5,332 shares of common stock have been
exercised.
Stock option information relating to the Director Plan is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Exercisable | |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
Weighted | |
|
|
Options | |
|
Option Price | |
|
Average | |
|
Available | |
|
|
|
Average | |
|
|
Outstanding | |
|
Range per Share | |
|
Exercise Price | |
|
for Grant | |
|
Number | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
December 31, 2002
|
|
|
120,000 |
|
|
$ |
7.00 - $13.25 |
|
|
$ |
9.54 |
|
|
|
74,688 |
|
|
|
61,668 |
|
|
$ |
10.03 |
|
Granted
|
|
|
35,000 |
|
|
$ |
11.64 |
|
|
$ |
11.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003
|
|
|
155,000 |
|
|
$ |
7.00 - $13.25 |
|
|
$ |
10.01 |
|
|
|
139,668 |
|
|
|
86,668 |
|
|
$ |
9.74 |
|
Granted
|
|
|
85,000 |
|
|
$ |
18.92 - $24.95 |
|
|
$ |
22.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004
|
|
|
240,000 |
|
|
$ |
7.00 - $24.95 |
|
|
$ |
14.28 |
|
|
|
54,668 |
|
|
|
130,001 |
|
|
$ |
9.87 |
|
Granted
|
|
|
45,000 |
|
|
$ |
7.77 |
|
|
$ |
7.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(21,666 |
) |
|
$ |
7.77 - $24.95 |
|
|
$ |
20.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005
|
|
|
263,334 |
|
|
$ |
7.00 - $24.95 |
|
|
$ |
12.61 |
|
|
|
131,334 |
|
|
|
181,669 |
|
|
$ |
12.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Combined Option Information |
The following table summarizes information about options under
the Equity Plan and the Director Plan outstanding at
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding | |
|
Exercisable | |
|
|
| |
|
| |
|
|
Options | |
|
Weighted | |
|
|
|
Options | |
|
|
|
|
Outstanding at | |
|
Average | |
|
Weighted | |
|
Exercisable at | |
|
Weighted | |
|
|
December 31, | |
|
Remaining | |
|
Average | |
|
December 31, | |
|
Average | |
Range of Exercise Prices |
|
2005 | |
|
Contractual Life | |
|
Exercise Price | |
|
2005 | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$ 4.48 - $ 7.10
|
|
|
704,974 |
|
|
|
6.13 |
|
|
$ |
6.26 |
|
|
|
383,419 |
|
|
$ |
6.08 |
|
$ 7.13 - $ 8.75
|
|
|
833,765 |
|
|
|
6.68 |
|
|
$ |
7.84 |
|
|
|
343,630 |
|
|
$ |
8.48 |
|
$ 8.78 - $13.75
|
|
|
873,427 |
|
|
|
4.81 |
|
|
$ |
11.17 |
|
|
|
740,918 |
|
|
$ |
11.27 |
|
$13.85 - $24.95
|
|
|
859,743 |
|
|
|
7.68 |
|
|
$ |
19.28 |
|
|
|
348,592 |
|
|
$ |
18.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,271,909 |
|
|
|
|
|
|
$ |
11.39 |
|
|
|
1,816,559 |
|
|
$ |
11.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1996 Employee Stock Purchase Plan |
The Company sponsors the Amended and Restated 1996 Employee
Stock Purchase Plan (the Purchase Plan) under which
employees may purchase shares of common stock at a discount from
fair market value at specified dates. Employees purchased
19,158 shares in 2005 at an average price of $5.43 per
share and 15,958 shares in 2004 at an average price of
$14.55 per share. At December 31, 2005, 16,750 common
shares remained available for issuance under the Purchase Plan.
The Purchase Plan is
F-18
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
intended to qualify as an employee stock purchase plan within
the meaning of Section 423 of the Internal Revenue Code of
1986, as amended (the Code). Rights to purchase
common stock under the Purchase Plan are granted at the
discretion of the Compensation Committee, which determines the
frequency and duration of individual offerings under the
Purchase Plan and the dates when stock may be purchased.
Eligible employees participate voluntarily and may withdraw from
any offering at any time before stock is purchased.
Participation terminates automatically upon termination of
employment. The purchase price per share of common stock in an
offering is 85% of the lesser of its fair market value at the
beginning of the offering period or on the applicable exercise
date and is paid through payroll deductions. The Purchase Plan
terminates in November 2006.
The Company has reported losses since inception and, due to the
degree of uncertainty related to the ultimate use of the net
operating loss carryforwards, has fully reserved this tax
benefit. The Company has the following deferred tax assets as of
December 31, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carry forwards
|
|
$ |
68,646,000 |
|
|
$ |
59,256,000 |
|
Research and development tax credits
|
|
|
8,381,000 |
|
|
|
7,406,000 |
|
Book over tax depreciation and amortization
|
|
|
2,582,000 |
|
|
|
2,272,000 |
|
Deferred revenue
|
|
|
451,000 |
|
|
|
1,394,000 |
|
Other
|
|
|
208,000 |
|
|
|
198,000 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
$ |
80,268,000 |
|
|
$ |
70,526,000 |
|
Valuation allowance
|
|
|
(80,268,000 |
) |
|
|
(70,526,000 |
) |
|
|
|
|
|
|
|
Deferred income taxes, net
|
|
$ |
0 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
As of December 31, 2005, the Company had net operating loss
carryforwards for Federal and State income tax purposes of
approximately $180.4 million and $121.8 million,
respectively, which expire through the year 2025 and 2010,
respectively. The valuation allowance increased by
$9.7 million during the year the ended December 31,
2005. The tax net operating loss carryforwards differ from the
accumulated deficit principally due to temporary differences in
the recognition of certain revenue and expense items for
financial and tax reporting purposes.
As a result of ownership changes resulting from sales of equity
securities, the Companys ability to use the net operating
loss carryforwards is subject to limitations as defined in
Sections 382 and 383 of the Code. The Company currently
estimates that the annual limitation on its use of net operating
losses generated through May 31, 1996 will be approximately
$900,000. Pursuant to Sections 382 and 383 of the Code, the
change in ownership resulting from public equity offerings in
1997 and other subsequent ownership changes may further limit
utilization of losses and credits in any one year. The Company
is also eligible for research and development tax credits, which
can be carried forward to offset federal taxable income. The
annual limitation and the timing of attaining profitability may
result in the expiration of net operating loss and tax credit
carryforwards before utilization.
F-19
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The reconciliation of income tax computed at the
U.S. federal statutory rate to income tax expense is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
Years Ended December 31, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Tax at U.S. statutory rate
|
|
$ |
(8,251,000 |
) |
|
$ |
(6,896,000 |
) |
|
$ |
(7,043,000 |
) |
|
|
(33.94 |
)% |
|
|
(33.84 |
)% |
|
|
(33.87 |
)% |
State taxes, net of federal benefit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.00 |
% |
|
|
0.00 |
% |
|
|
0.00 |
% |
Permanent differences, net of federal benefit
|
|
|
19,021 |
|
|
|
21,629 |
|
|
|
26,894 |
|
|
|
0.08 |
% |
|
|
0.11 |
% |
|
|
0.13 |
% |
Foreign taxes
|
|
|
41,991 |
|
|
|
99,905 |
|
|
|
80,075 |
|
|
|
0.17 |
% |
|
|
0.49 |
% |
|
|
0.39 |
% |
Operating losses not benefited
|
|
|
8,231,979 |
|
|
|
6,874,371 |
|
|
|
7,016,106 |
|
|
|
33.86 |
% |
|
|
33.73 |
% |
|
|
33.74 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
$ |
41,991 |
|
|
$ |
99,905 |
|
|
$ |
80,075 |
|
|
|
0.17 |
% |
|
|
0.49 |
% |
|
|
0.39 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11. |
Defined Contribution Plan |
The Company offers a defined contribution 401(k) plan, which
covers substantially all employees. The plan permits
participants to make contributions from 1% to 15% of their
compensation. Beginning in 1999, the Company began matching up
to 3% of employees contributions. During 2005, 2004 and
2003, the Companys match amounted to $243,486, $227,994,
and $200,801, respectively.
|
|
12. |
Strategic Alliances and Collaborations |
The Companys business strategy includes entering into
alliances with companies primarily in the pharmaceutical
industry to facilitate the development, manufacture, marketing,
sale and distribution of EPIX products.
In June 2000, the Company entered into a strategic collaboration
agreement for Vasovist pursuant to which it granted Schering AG
an exclusive license to co-develop and market Vasovist
worldwide, excluding Japan. In December 2000, the Company
amended this strategic collaboration agreement to grant to
Schering AG the exclusive rights to develop and market Vasovist
in Japan. Generally, each party to the agreement will share
equally in Vasovist costs and profits. Under the agreement, the
Company will assume responsibility for completing clinical
trials and filing for FDA approval in the U.S. Schering AG
will lead clinical and regulatory activities for the product
outside the U.S. In addition, the Company granted Schering
AG an exclusive option to develop and market an unspecified
vascular MRI blood pool agent from its product pipeline. In
connection with this strategic collaboration and the amendment
to its strategic collaboration agreement with Tyco/
Mallinckrodt, as further described below, Schering AG paid the
Company an up-front fee of $10.0 million, which the Company
then paid to Tyco/ Mallinckrodt. Under the agreement, Schering
AG also paid the Company $20.0 million in exchange for
shares of the Companys common stock through its affiliate,
Schering AG Berlin Venture Corporation, or Schering AG BV.
The Company may receive up to an additional $23.3 million
in milestone payments under the strategic collaboration
agreement, of which up to $1.3 million may be earned upon
U.S. product approval. Following commercial launch of
Vasovist, the Company will also be entitled to receive a royalty
on products sold outside the U.S. and a percentage of Schering
AGs operating profit margin on products sold in the U.S.
Also, under the strategic collaboration agreement with Schering
AG, the Company has options to acquire certain participation
rights with respect to two of Schering AGs MRI imaging
products currently
F-20
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
in clinical trials, SHU555C and Gadomer. The Company is entitled
to exercise these options on a region-by-region basis upon the
payment of certain fees. If the Company exercises the SHU555C
option, the Company will enter into a definitive agreement with
Schering AG with respect to SHU555C, pursuant to which Schering
AG will be responsible for the conduct of all development,
marketing and sales activities in connection with SHU555C. If
the Company exercises the Gadomer option, it will enter into a
definitive agreement with Schering AG with respect to Gadomer,
pursuant to which the Company will share development costs
incurred from the date of the option exercise, as well as
profits, equally with Schering AG and it will be obligated to
make milestone payments to Schering AG.
Under the terms of the strategic collaboration agreement for
Vasovist, either party may terminate the agreement upon thirty
days notice if there is a material breach of the contract or if
either party fails to meet certain milestones. In addition,
Schering AG may terminate the agreement at any time on a
region-by-region basis or in its entirety, upon six months
written notice to the Company; and the Company may terminate the
agreement with respect to development of Vasovist in the E.U. at
any time upon ninety days written notice to Schering AG, if
Schering AG has failed to meet its obligations in connection
with the regulatory approval of Vasovist in the E.U.
In May 2003, the Company announced a broad alliance with
Schering AG for the discovery, development and commercialization
of molecularly-targeted contrast agents for MRI. The alliance is
comprised of two areas of collaboration with one agreement
providing for exclusive development and commercialization
collaboration for EP-2104R, the Companys product candidate
for the detection of thrombus, as well as any other product
candidate that the Company and Schering AG determine to develop
for detection of thrombus using MRI, and the second agreement
covering an exclusive research collaboration to discover novel
compounds for diagnosing human disease using MRI. As a result of
the alliance, Schering AG has an option to the late stage
development and worldwide marketing rights for
EP-2104R, other
thrombus imaging agents and for all development candidates
emerging from the MRI research collaboration.
Under the terms of the EP-2104R agreement, the Company is
responsible for execution of a clinical feasibility program in
humans. At the end of the feasibility program, Schering AG may
exercise an option to develop and commercialize EP-2104R under
which Schering AG will receive an exclusive, worldwide license
for EP-2104R and become responsible for all further development,
manufacturing, marketing and sales. Schering AG made fixed
payments to the Company totaling approximately $9.0 million
to cover its expenditures in the feasibility program. In
addition, if Schering AG exercises its option to develop and
commercialize EP-2104R, Schering AG will pay the Company up to
$15.0 million in additional payments upon the occurrence of
certain development and commercial events as well as royalties
on sales attributable to the EP-2104R development effort. The
royalty rate will depend on the level of annual net sales. In
addition to funding for the feasibility program and milestone
and base royalty payments, the Company has the right to increase
its royalty rate by paying to Schering AG a portion of the costs
of clinical development.
Under the terms of the MRI three-year joint research agreement,
the Company and Schering AG have exclusively combined the
Companys existing research programs in the field of
diagnosing human disease using MRI to discover novel MRI product
candidates for clinical development. Schering AG funds a portion
of the Companys related personnel costs and third party
research costs of up to $2.0 million per annum. Also under
the MRI research agreement, Schering AG has the first option to
obtain exclusive, worldwide rights for the product candidates
and, upon exercising the option, would become responsible for
all future development, manufacturing, marketing and sales. The
Company would receive a base royalty on net sales with the
option to increase the royalty by participating in development
funding. If Schering AG does not exercise its option, the
Company may license the product and Schering AG would receive a
base royalty on net sales and milestone payments.
F-21
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
In October 2005, the Company announced that an amendment to the
research collaboration agreement had been entered into with
Schering AG. This amendment narrows the definition of the field
of its collaboration with Schering AG. This research
collaboration expires in May 2006, and the Company believes that
it is unlikely that the parties will extend the term of the
collaboration. The Company expects to discuss the disposition of
current research programs with Schering AG prior to expiration
of the collaboration and to continue to advance at least some of
these programs either unilaterally or with another partner.
In May 2003, the Company entered into a loan agreement with
Schering AG which entitled it to borrow up to $15 million
from time to time. The Company has repaid the loan in full and
in January 2006, the Company terminated the loan agreement with
Schering AG.
On May 8, 2000, the Company granted to Schering AG a
worldwide, royalty-bearing license to patents covering Schering
AGs development project, Primovist, an MRI contrast agent
for imaging the liver, approved in the E.U. in 2004. Also on
May 8, 2000, Schering AG granted the Company a
non-exclusive, royalty-bearing license to certain of its
Japanese patents. The Company agreed to withdraw its
invalidation claim of Schering AGs Japanese patent
1,932,626 in the Japanese Patent Office pursuant to this license
agreement. See Patents and Proprietary Rights.
Schering AG had been an opposing party in the Companys
European patent case prior to the licensing agreement. On
May 9, 2000, the Opposition Division of the European Patent
Office maintained the Companys European patent in a
slightly amended form. The patent is owned by MGH and is
exclusively licensed to the Company. The remaining opposing
parties initially elected to appeal the May 9, 2000
decision. However, in September 2001, the Company settled this
patent dispute with the opposing parties by entering into a
non-exclusive royalty bearing license agreement with Bracco. See
Item 1. Business Patents and Proprietary
Rights in the accompanying
Form 10-K for
further discussion of this settlement.
In June 2000, in connection with the exclusive license that the
Company granted to Schering AG, the Company amended its
strategic collaboration with Tyco/ Mallinckrodt to grant Tyco/
Mallinckrodt a non-exclusive, worldwide license to manufacture
Vasovist for clinical development and commercial use in
accordance with a manufacturing agreement entered into in June
2000 between Tyco/ Mallinckrodt and Schering AG, and to enable
the Company to enter into the strategic collaboration agreement
with Schering AG described above. In connection with this
amendment, the Company paid Tyco/ Mallinckrodt an up-front fee
of $10.0 million and are obligated to pay up to an
additional $5.0 million in milestone payments, of which
$2.5 million was paid following NDA filing in February 2004
and $2.5 million will be paid upon U.S. product
approval. The Company will also pay Tyco/ Mallinckrodt a share
of its Vasovist operating profit margins in the U.S. and a
percentage of the royalty that it receives from Schering AG on
Vasovist gross profits outside the U.S.
In March 1996, the Company entered into a development and
license agreement with Daiichi pursuant to which it granted
Daiichi an exclusive license to develop and commercialize
Vasovist in Japan. Under this arrangement, Daiichi assumed
primary responsibility for clinical development, regulatory
approval, marketing and distribution of Vasovist in Japan. The
Company retained the right and obligation to manufacture
Vasovist for development activities and commercial sale under
the agreement. In December 2000, the Company reacquired the
rights to develop and commercialize Vasovist in Japan from
Daiichi. Under the terms of this reacquisition agreement with
Daiichi, the Company agreed to pay Daiichi a total amount of
$5.2 million, of which it paid $2.8 million in January
2001 and $2.4 million in December 2003. Daiichi will also
receive a royalty from the Company based on net sales of
Vasovist in Japan.
F-22
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Simultaneously with its reacquisition from Daiichi of the
Vasovist development and marketing rights in Japan, the Company
assigned these rights to Schering AG as described above.
The Company entered into a collaboration agreement in 1997 and
two further collaboration and license agreements in November
2004 with Dyax Corp., (Dyax), for research relating
to the Companys thrombus program and other research
programs. Under the terms of the thrombus program agreements
with Dyax, the Company has exclusive worldwide rights to develop
and commercialize ligands and derivatives of fibrin-binding
peptides discovered during the research collaboration with Dyax.
These rights include both an exclusive license to diagnostic
imaging compounds (excluding radiopharmaceuticals) as well as
therapeutic compounds. In return for these exclusive license
rights, the Company agreed to pay Dyax certain specified
research related payments, milestone payments and royalties upon
commercialization of certain products arising from the these
programs.
The Company has entered into a license agreement with MGH
pursuant to which MGH has granted the Company an exclusive
worldwide license to the patents and patent applications which
relate to Vasovist. The MGH license imposed certain due
diligence obligations with respect to the development of
products covered by the license, all of which have been
fulfilled to date. The MGH license requires the Company to pay
royalties on its net sales of Vasovist until 2006. The Company
must also pay MGH a percentage of all royalties received from
its sublicensees until 2006 or later on any sublicense if the
MGH patents related to that sublicense are extended.
In November 2003, the Company entered into an intellectual
property agreement with Dr. Martin R. Prince, an early
innovator in the field of MRA relating to dynamic
MRA, which involves capturing MRA images during the limited
time, typically 30 to 60 seconds, available for imaging with
extracellular agents. Under the terms of the intellectual
property agreement, Dr. Prince made certain covenants and
agreements and granted the Company certain discharges, licenses
and releases in connection with the use of Vasovist. In
consideration of Dr. Prince entering into this agreement,
the Company agreed to pay him an upfront fee and royalties on
sales of Vasovist consistent with a non-exclusive early stage
academic license and agreed to deliver to him
132,000 shares of EPIX common stock and certain quantities
of Vasovist.
|
|
|
Dismissal of class action lawsuit |
On January 31, 2006, the U.S. District Court for the
District of Massachusetts granted the Companys Motion to
Dismiss for Failure to Prosecute the previously disclosed
shareholder class action lawsuit against the Company. The
dismissal was issued without prejudice after a hearing, which
dismissal does not prevent another suit to be brought based on
the same claims.
F-23
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
14. Quarterly Financial Information (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter | |
|
Second Quarter | |
|
Third Quarter | |
|
Fourth Quarter | |
|
|
|
|
Ended | |
|
Ended | |
|
Ended | |
|
Ended | |
|
|
|
|
March 31, | |
|
June 30, | |
|
September 30, | |
|
December 31, | |
|
Total | |
|
|
2005 | |
|
2005 | |
|
2005 | |
|
2005 | |
|
Year | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product development revenue
|
|
$ |
1,475,819 |
|
|
$ |
314,026 |
|
|
$ |
1,297,720 |
|
|
$ |
1,107,965 |
|
|
$ |
4,195,530 |
|
|
Royalty revenue
|
|
|
444,289 |
|
|
|
578,321 |
|
|
|
798,484 |
|
|
|
512,290 |
|
|
|
2,333,384 |
|
|
License fee revenue
|
|
|
165,896 |
|
|
|
165,896 |
|
|
|
165,894 |
|
|
|
163,061 |
|
|
|
660,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
2,086,004 |
|
|
|
1,058,243 |
|
|
|
2,262,098 |
|
|
|
1,783,316 |
|
|
|
7,189,661 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research Development
|
|
|
5,533,151 |
|
|
|
5,637,426 |
|
|
|
5,498,385 |
|
|
|
4,106,809 |
|
|
|
20,775,771 |
|
General & administrative
|
|
|
2,743,705 |
|
|
|
2,570,535 |
|
|
|
2,617,410 |
|
|
|
2,312,621 |
|
|
|
10,244,271 |
|
Restructuring costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
971,828 |
|
|
|
971,828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
8,276,856 |
|
|
|
8,207,961 |
|
|
|
8,115,795 |
|
|
|
7,391,258 |
|
|
|
31,991,870 |
|
Operating Loss
|
|
|
(6,190,852 |
) |
|
|
(7,149,718 |
) |
|
|
(5,853,697 |
) |
|
|
(5,607,942 |
) |
|
|
(24,802,209 |
) |
Other income, net
|
|
|
(64,703 |
) |
|
|
53,634 |
|
|
|
193,940 |
|
|
|
350,471 |
|
|
|
533,342 |
|
Income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,991 |
|
|
|
41,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(6,255,555 |
) |
|
$ |
(7,096,084 |
) |
|
$ |
(5,659,757 |
) |
|
$ |
(5,299,462 |
) |
|
$ |
(24,310,858 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares, basic and diluted
|
|
|
23,226,677 |
|
|
|
23,257,197 |
|
|
|
23,273,075 |
|
|
|
23,275,104 |
|
|
|
23,258,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$ |
(0.27 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.23 |
) |
|
$ |
(1.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-24
EPIX PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter | |
|
Second Quarter | |
|
Third Quarter | |
|
Fourth Quarter | |
|
|
|
|
Ended | |
|
Ended | |
|
Ended | |
|
Ended | |
|
|
|
|
March 31, | |
|
June 30, | |
|
September 30, | |
|
December 31, | |
|
Total | |
|
|
2004 | |
|
2004 | |
|
2004 | |
|
2004 | |
|
Year | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product development revenue
|
|
$ |
2,651,925 |
|
|
$ |
1,962,067 |
|
|
$ |
2,273,957 |
|
|
$ |
706,331 |
|
|
$ |
7,594,280 |
|
|
Royalty revenue
|
|
|
688,453 |
|
|
|
1,009,062 |
|
|
|
700,601 |
|
|
|
(1,771,431 |
)(1) |
|
|
626,685 |
|
|
License fee revenue
|
|
|
283,288 |
|
|
|
275,175 |
|
|
|
263,585 |
|
|
|
3,215,588 |
|
|
|
4,037,636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
3,623,666 |
|
|
|
3,246,304 |
|
|
|
3,238,143 |
|
|
|
2,150,488 |
|
|
|
12,258,601 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research Development
|
|
|
5,513,267 |
|
|
|
5,073,265 |
|
|
|
6,508,418 |
|
|
|
4,779,041 |
|
|
|
21,873,991 |
|
General & administrative
|
|
|
2,171,976 |
|
|
|
3,119,630 |
|
|
|
2,878,916 |
|
|
|
2,324,855 |
|
|
|
10,495,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
7,685,243 |
|
|
|
8,192,895 |
|
|
|
9,387,334 |
|
|
|
7,103,896 |
|
|
|
32,369,368 |
|
Operating Loss
|
|
|
(4,061,577 |
) |
|
|
(4,946,591 |
) |
|
|
(6,149,191 |
) |
|
|
(4,953,408 |
) |
|
|
(20,110,767 |
) |
Other income, net
|
|
|
203,017 |
|
|
|
8,576 |
|
|
|
(246,645 |
) |
|
|
(135,534 |
) |
|
|
(170,586 |
) |
Income taxes
|
|
|
8,719 |
|
|
|
20,947 |
|
|
|
16,676 |
|
|
|
53,563 |
|
|
|
99,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,867,279 |
) |
|
$ |
(4,958,962 |
) |
|
$ |
(6,412,512 |
) |
|
$ |
(5,142,505 |
) |
|
$ |
(20,381,258 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares, basic and diluted
|
|
|
22,622,249 |
|
|
|
22,818,822 |
|
|
|
22,987,878 |
|
|
|
23,122,088 |
|
|
|
22,888,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$ |
(0.17 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.89 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Reflects the Companys decision to recognize the full
$1.8 million of Braccos assertion that Bracco had
overstated
non-U.S.
royalties to the Company during the period 2001 to 2004. In
addition, the Company believes that it no longer has a
reasonable basis to make royalty estimates and will therefore,
effective in the fourth quarter of 2004, recognize future
royalties from Bracco in the period in which royalty reports are
received. |
F-25
REPORT OF INDEPENDENT AUDITORS
The Board of Directors and Shareholders of Predix
Pharmaceuticals Holdings, Inc.
We have audited the accompanying consolidated balance sheets of
Predix Pharmaceuticals Holdings, Inc. as of
December 31, 2004 and 2005, and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2005. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the auditing
standards generally accepted in the United States. Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes consideration
of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over
financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and
significant estimates made by management, and evaluating the
overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the consolidated
financial position of Predix Pharmaceuticals Holdings, Inc. at
December 31, 2004 and 2005, and the consolidated results of
its operations and its cash flows for each of the three years in
the period ended December 31, 2005, in conformity with
accounting principles generally accepted in the United States.
As discussed in Note 1 to the consolidated financial
statements, the Companys recurring losses from operations
and negative cash flows from operations raise substantial doubt
about its ability continue as a going concern. Managements
plans as to these matters are also described in Note 1. The
accompanying financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Boston, Massachusetts
March 29, 2006,
except for Note 14, as to which the date is April 3,
2006
F-26
PREDIX PHARMACEUTICALS HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
December 31 | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(In thousands, except per | |
|
|
share amounts) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
5,912 |
|
|
$ |
13,813 |
|
|
Marketable securities
|
|
|
1,501 |
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
2,016 |
|
|
|
1,037 |
|
|
|
|
|
|
|
|
Total current assets
|
|
|
9,429 |
|
|
|
14,850 |
|
Restricted cash
|
|
|
931 |
|
|
|
714 |
|
Property and equipment, net
|
|
|
1,399 |
|
|
|
1,075 |
|
Other assets
|
|
|
40 |
|
|
|
78 |
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
11,799 |
|
|
$ |
16,717 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
2,477 |
|
|
$ |
1,072 |
|
|
Accrued expenses
|
|
|
4,637 |
|
|
|
1,538 |
|
|
Current portion of deferred revenue
|
|
|
760 |
|
|
|
|
|
|
Current portion of capital lease obligations
|
|
|
89 |
|
|
|
223 |
|
|
Current portion of lease abandonment liability
|
|
|
152 |
|
|
|
219 |
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
8,115 |
|
|
|
3,052 |
|
Accrued rent
|
|
|
440 |
|
|
|
|
|
Deferred revenue, net of current portion
|
|
|
778 |
|
|
|
|
|
Capital lease obligations, net of current portion
|
|
|
109 |
|
|
|
127 |
|
Lease abandonment liability, net of current portion
|
|
|
1,109 |
|
|
|
1,068 |
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
10,551 |
|
|
|
4,247 |
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; 275,298,740 and
238,223,800 shares authorized at December 31, 2005 and
2004, respectively: 273,203,492 and 115,838,473 shares
issued and outstanding at December 31, 2005 and 2004,
respectively
|
|
|
2,732 |
|
|
|
1,159 |
|
|
Common stock, $0.01 par value; 338,085,813 and
309,642,245 shares authorized at December 31, 2005 and
2004, respectively: 1,044,059 and 662,590 shares issued and
outstanding at December 31, 2005 and 2004, respectively
|
|
|
10 |
|
|
|
7 |
|
|
Additional paid-in capital
|
|
|
122,200 |
|
|
|
98,999 |
|
|
Deferred compensation
|
|
|
(2,294 |
) |
|
|
|
|
|
Accumulated other comprehensive income
|
|
|
(1 |
) |
|
|
1 |
|
|
Accumulated deficit
|
|
|
(121,399 |
) |
|
|
(87,696 |
) |
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,248 |
|
|
|
12,470 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
11,799 |
|
|
$ |
16,717 |
|
|
|
|
|
|
|
|
See accompanying notes
F-27
PREDIX PHARMACEUTICALS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31 | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share | |
|
|
amounts) | |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product development revenue
|
|
$ |
1,737 |
|
|
$ |
|
|
|
$ |
|
|
|
License fee revenue
|
|
|
563 |
|
|
|
13 |
|
|
|
1,068 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue
|
|
|
2,300 |
|
|
|
13 |
|
|
|
1,068 |
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
29,351 |
|
|
|
16,427 |
|
|
|
14,632 |
|
General and administrative
|
|
|
7,031 |
|
|
|
3,011 |
|
|
|
5,782 |
|
Restructuring
|
|
|
205 |
|
|
|
77 |
|
|
|
5,350 |
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
36,587 |
|
|
|
19,515 |
|
|
|
25,764 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(34,287 |
) |
|
|
(19,502 |
) |
|
|
(24,696 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net
|
|
|
614 |
|
|
|
147 |
|
|
|
142 |
|
|
Interest expense
|
|
|
(30 |
) |
|
|
(37 |
) |
|
|
(6 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(33,703 |
) |
|
$ |
(19,392 |
) |
|
$ |
(24,560 |
) |
|
|
|
|
|
|
|
|
|
|
See accompanying notes
F-28
PREDIX PHARMACEUTICALS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class A |
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
New | |
|
|
|
Common Stock |
|
|
|
Additional | |
|
|
|
|
|
Other | |
|
|
|
Total | |
|
|
| |
|
| |
|
Common Stock | |
|
|
|
|
|
Deferred | |
|
Paid-in | |
|
Notes | |
|
Treasury | |
|
Comprehensive | |
|
Accumulated | |
|
Stockholders | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount |
|
Shares | |
|
Amount |
|
Compensation | |
|
Capital | |
|
Receivable | |
|
Stock | |
|
Loss | |
|
Deficit | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except share amounts) | |
Balance at December 31, 2002
|
|
|
19,111,135 |
|
|
$ |
59,167 |
|
|
|
|
|
|
$ |
|
|
|
|
15,757 |
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
23,473 |
|
|
$ |
(676 |
) |
|
$ |
(40 |
) |
|
$ |
30 |
|
|
$ |
(55,814 |
) |
|
$ |
26,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,560 |
) |
|
|
(24,560 |
) |
Realized gains, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(30 |
) |
|
|
|
|
|
|
(30 |
) |
Unrealized gain on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,590 |
) |
Repurchase of restricted stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,678 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12 |
) |
|
|
676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
664 |
|
Cancellation of treasury stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Cancellation of stock on acquisition
|
|
|
(19,111,135 |
) |
|
|
(59,167 |
) |
|
|
|
|
|
|
|
|
|
|
(11,308 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reversal of Series D accretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,070 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,070 |
|
|
|
|
|
Issuance of Preferred Stock on acquisition
|
|
|
2,532,225 |
|
|
|
26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26 |
|
Issuance of Common Stock on acquisition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,643 |
|
Issuance of Common Stock A on acquisition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,343 |
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
Employee stock purchases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,493 |
|
|
|
|
|
|
|
|
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
2,532,225 |
|
|
|
26 |
|
|
|
|
|
|
|
|
|
|
|
14,731 |
|
|
|
|
|
|
|
19,836 |
|
|
|
|
|
|
|
|
|
|
|
78,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(68,304 |
) |
|
|
9,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,392 |
) |
|
|
(19,392 |
) |
Realized gains, net unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,391 |
) |
Write off of receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
Issuance of Preferred Stock
|
|
|
96,249,667 |
|
|
|
963 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,056 |
|
Conversion of Preferred Stock
|
|
|
11,999,235 |
|
|
|
119 |
|
|
|
599,447 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(127 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Conversion of Common Stock
|
|
|
|
|
|
|
|
|
|
|
34,566 |
|
|
|
|
|
|
|
(14,731 |
) |
|
|
|
|
|
|
(19,836 |
) |
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Exercise of stock warrants
|
|
|
5,057,346 |
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
874 |
|
Employee stock purchases
|
|
|
|
|
|
|
|
|
|
|
28,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
115,838,473 |
|
|
|
1,159 |
|
|
|
662,590 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98,999 |
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
(87,696 |
) |
|
|
12,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,703 |
) |
|
|
(33,703 |
) |
Realized gains, net unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
|
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,705 |
) |
Issuance of Preferred Stock
|
|
|
94,460,059 |
|
|
|
944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,594 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,538 |
|
Exercise of stock warrants
|
|
|
62,904,960 |
|
|
|
629 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,095 |
|
Employee stock purchases
|
|
|
|
|
|
|
|
|
|
|
381,469 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
319 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
322 |
|
Issuance of stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,822 |
) |
|
|
2,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense related to stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
273,203,492 |
|
|
|
2,732 |
|
|
|
1,044,059 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,294 |
) |
|
|
122,200 |
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
(121,399 |
) |
|
|
1,248 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-29
PREDIX PHARMACEUTICALS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31 | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(33,703 |
) |
|
$ |
(19,392 |
) |
|
$ |
(24,560 |
) |
Adjustments to reconcile net loss to cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of property and equipment
|
|
|
|
|
|
|
27 |
|
|
|
2,169 |
|
|
Write-off of research and development
|
|
|
|
|
|
|
|
|
|
|
6,611 |
|
|
Depreciation and amortization
|
|
|
433 |
|
|
|
349 |
|
|
|
1,364 |
|
|
Loss on sale of property and equipment
|
|
|
14 |
|
|
|
1 |
|
|
|
|
|
|
Accretion of lease liability net present value
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
Write-off of stock subscription receivable
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
Non-cash stock based compensation
|
|
|
552 |
|
|
|
|
|
|
|
664 |
|
|
Realized gain on sale of short-term investments
|
|
|
|
|
|
|
(1 |
) |
|
|
(30 |
) |
|
Changes in operating assets and liabilities exclusive of impact
from net asset acquisition (Note 6):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
(979 |
) |
|
|
(620 |
) |
|
|
409 |
|
|
|
Other assets
|
|
|
43 |
|
|
|
(46 |
) |
|
|
1,123 |
|
|
|
Accounts payable, accrued expenses and deferred revenue
|
|
|
5,268 |
|
|
|
1,033 |
|
|
|
544 |
|
|
|
Long-term liabilities
|
|
|
984 |
|
|
|
(264 |
) |
|
|
1,202 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(27,183 |
) |
|
|
(18,910 |
) |
|
|
(10,504 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net asset acquisition, net of cash acquired
|
|
|
|
|
|
|
|
|
|
|
(318 |
) |
Purchase of short-term investments
|
|
|
(3,494 |
) |
|
|
|
|
|
|
(3,657 |
) |
Restricted cash
|
|
|
(217 |
) |
|
|
238 |
|
|
|
(952 |
) |
Proceeds from sale of short-term investments
|
|
|
1,989 |
|
|
|
3,658 |
|
|
|
13,892 |
|
Purchase of property and equipment
|
|
|
(705 |
) |
|
|
(278 |
) |
|
|
(144 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(2,427 |
) |
|
|
3,618 |
|
|
|
8,821 |
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock for net asset acquisition
|
|
|
|
|
|
|
|
|
|
|
1,058 |
|
Proceeds from issuance of common stock for option exercises
|
|
|
324 |
|
|
|
23 |
|
|
|
22 |
|
Proceeds from issuance of preferred stock and exercises of
warrants, net of issuance costs
|
|
|
21,608 |
|
|
|
21,929 |
|
|
|
|
|
Principal payments on capital leases
|
|
|
(223 |
) |
|
|
(188 |
) |
|
|
(140 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
21,709 |
|
|
|
21,764 |
|
|
|
940 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(7,901 |
) |
|
|
6,472 |
|
|
|
(743 |
) |
Cash and cash equivalents, beginning of period
|
|
|
13,813 |
|
|
|
7,341 |
|
|
|
8,084 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$ |
5,912 |
|
|
$ |
13,813 |
|
|
$ |
7,341 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information Cash paid for interest
|
|
$ |
29 |
|
|
$ |
37 |
|
|
$ |
28 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
F-30
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Predix Pharmaceuticals Holdings, Inc. (Predix or the Company) is
a pharmaceutical company focused on the discovery and
development of novel, highly selective, small-molecule drugs
that target G-protein coupled receptors, or GPCRs, and ion
channels. The Companys lead clinical-stage drug candidate,
PRX-00023, is in Phase III clinical trials for Generalized
Anxiety Disorder. The Company has two other clinical-stage drug
candidates, PRX-03140 for the treatment of Alzheimers
disease and PRX-08066 for the treatment of Pulmonary
Hypertension. PRX-03140 and
PRX-08066 have
completed Phase I clinical trial programs. The
Companys corporate headquarters is located in Lexington,
Massachusetts.
The Company was incorporated in Delaware on November 2,
1994 as Takhus Pharmaceuticals, Inc. and changed its name in
December 1996 to Physiome Sciences, Inc. Prior to 2003, the
Company was focused on the development and commercialization of
software and databases used to support the discovery and
development of new drugs. In late 2002, the board of directors
decided to change the business focus of the Company and began
actively pursuing the sale or merger of the Company to or with a
company engaged in drug discovery. In August 2003, the Company
acquired all of the capital stock of Predix Pharmaceuticals Ltd.
(Predix Limited), an Israeli corporation, and
changed its name to Predix Pharmaceuticals Holdings, Inc.
Subsequent to the acquisition of Predix Pharmaceuticals Ltd.,
the company changed its business focus to drug discovery and
development focusing on GPCRs and ion channels, using its
software, together with the proprietary technology it acquired.
The acquisition was accounted for under the purchase method of
accounting. The purchase price of $7.7 million was funded
with the common and preferred stock of Physiome Sciences, Inc.
The purchase price was allocated to the net tangible assets
acquired ($1.0 million) and $6.7 million was charged
to operating expenses pursuant to Financial Accounting
Interpretation No. 4 (FIN 4), Applicability of FASB
Statement No. 2 to Business Combinations Accounted for by
the Purchase Method an interpretation of FASB Statement
No. 2. The acquired entity was a development stage
enterprise at the time of the acquisition, as defined in
Statement of Financial Accounting Standards (SFAS)
No. 7, Consolidated Financial Statements
(SFAS No. 7) therefore, no goodwill
was recorded.
The future success of the Company may be dependent on its
ability to obtain additional working capital to develop and
market its future products and ultimately upon its ability to
attain future profitable operations. There can be no assurances
that the Company will be able to obtain necessary financing to
successfully develop and market its future products or attain
successful future operations. Further, the Company is subject to
risks associated with emerging biotechnology companies. Primary
among these risks is competition from other entities in the
industry with competing drug discovery programs and the success
of efforts to develop and market future products.
The accompanying consolidated financial statements have been
prepared assuming the Company will continue as a going concern.
As shown in the financial statements, the Company at
December 31, 2005 has an accumulated deficit of
$121.4 million and has incurred significant operating
losses and negative cash flows from operations in each of the
three years ended December 31, 2005. As a result, there
exists substantial doubt about its ability to continue as a
going concern through December 31, 2006. To address this
matter, the Company entered into a bridge financing agreement
with certain of its shareholders, in which the Company issued
notes totaling $9.5 million. In addition, the Company
announced the signing of a definitive merger agreement whereby
EPIX Pharmaceuticals, Inc. (EPIX) will acquire
Predix in a transaction valued at approximately
$90 million, including the assumption of net debt at
closing. The merger is subject to approval by both EPIXs
and Predixs stockholders, regulatory approval and other
closing conditions, and is expected to close by the end of July
2006 (see Note 14). Absent the pending approval of the
merger, the Company will need to raise additional capital during
2006 through the sale of debt or equity securities, development
of new products and services or acquisition of complementary
products, businesses, or technologies in order to fund future
operations until December 31, 2006.
F-31
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Additional capital may not be available on terms favorable to
the Company, or at all. The accompanying financial statements do
not include any adjustments that might result from the outcome
of this uncertainty.
|
|
2. |
Summary of Significant Accounting Policies |
The accompanying consolidated financial statements of the
Company include the accounts of the Company and its wholly owned
subsidiary located in Israel, Predix Limited. All significant
intercompany accounts have been eliminated in consolidation. The
net assets of Predix Limited were $1.8 million and
$2.3 million at December 31, 2004 and 2005,
respectively.
In September 2005, the board of directors and stockholders
approved a 1-for-18
reverse stock split of the outstanding shares of common stock
and an adjusted conversion ratio of Series C and
Series AB convertible preferred stock to reflect the
1-for-18 reverse stock
split of the common stock. All common share and related per
share amounts (except par value which remains $0.01) for all
periods presented have been retroactively adjusted for the
1-for-18 reverse stock
split.
The preparation of the financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and
expenses during the reporting period. Actual results could
differ from those estimates.
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|
|
Cash equivalents and marketable securities |
Cash equivalents consist principally of money market funds.
Marketable securities consist of investments in
U.S. government bonds. The Company considers all highly
liquid investments with maturities of three months or less at
the time of purchase to be cash equivalents. Cash equivalents
are stated at cost, which approximates fair value.
Management determines the appropriate classification of
marketable securities at the time of purchase and reevaluates
such designation at each balance sheet date. Marketable
securities at December 31, 2005 are classified as
available-for-sale. Available-for-sale securities are carried at
fair value, with the unrealized gains and losses reported in a
separate component of stockholders equity. The cost of
debt securities in this category is adjusted for amortization of
premiums and accretion of discounts to maturity. Such
amortization and accretion are included in investment income.
Realized gains and losses and declines in value judged to be
other-than-temporary on available-for-sale securities and other
investments are included in investment income. The cost of
securities sold is based on the specific identification method.
Interest and dividends on securities classified as
available-for-sale are included in investment income.
During the years ended December 31, 2003 and 2004, there
were net realized gains (losses) on marketable securities of
$(30,267) and $560, respectively. There were no net realized
gains (losses) on marketable securities during the year ended
December 31, 2005. At December 31, 2005 and 2004, cash
equivalents were held in money market accounts with commercial
banks. There are no available for sale marketable securities
that have been in an unrealized loss position for more than a
year.
F-32
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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|
|
Concentrations of credit risk |
SFAS No. 105, Disclosure of Information About
Financial Instruments with Off-Balance-Sheet Risk and Financial
Instruments with Concentration of Credit Risk (SFAS 105),
requires disclosure of any significant off-balance-sheet risk or
credit risk concentration.
The Company has no significant off-balance-sheet risk.
Financial instruments that potentially subject the Company to
concentration of credit risk principally consist of cash and
cash equivalents and marketable securities. Cash and cash
equivalents are placed with highly rated financial institutions.
The Company places the marketable securities with highly rated
financial institutions and has not experienced significant
losses in such accounts. The Company does not believe it is
exposed to any significant credit risk on these funds.
SFAS No. 131, Disclosures about Segments of an
Enterprise and Related Information
(SFAS No. 131), establishes standards
for the way that public business enterprises report information
about operating segments in their financial statements.
SFAS No. 131 also establishes standards for related
disclosures about products and services, geographic areas, and
major customers.
Operating segments are determined based on the way management
organizes its business for making operating decisions and
assessing performance.
In determining the operating segments, the Company considered
its wholly-owned subsidiary, Predix Limited, as well as the
former business practice of licensing software. Predix limited
is primarily an offsite chemistry facility. The financial
results of Predix Limited are not used to make operating
decisions nor to assess Company performance. The Company no
longer licenses software but uses the software formerly licensed
together with its proprietary technology in its drug discovery
efforts.
The Company makes operating decisions based upon performance of
the Company as a whole and utilizes the consolidated financial
statements for decision making. The Company operates in one
business segment, which focuses on drug discovery and
development.
Property and equipment are stated at cost. Depreciation is
recorded using the straight-line method over the estimated
useful lives of the respective assets. Upon sale or retirement,
the cost, if any, and related accumulated depreciation are
eliminated from the respective accounts and the resulting gain
or loss is included in current operations. Repairs and
maintenance charges that do not increase the useful life of the
assets are charged to operations as incurred. Property and
equipment are depreciated on a straight-line basis over the
following periods:
|
|
|
Laboratory equipment
|
|
5 years |
Computer equipment and software
|
|
3 years |
Leasehold improvements
|
|
Shorter of life of lease or useful life of asset |
Furniture and fixtures
|
|
7 years |
|
|
|
Impairment of Long-Lived Assets |
Consistent with SFAS No. 144, Accounting for the
Impairment of Long-Lived Assets and Long-Lived Assets to be
Disposed of (SFAS No. 144), when impairment
indicators exist, the Company evaluates its long-lived assets
for potential impairment. Potential impairment is assessed when
there is evidence that events or changes in circumstances
indicate that the carrying amount of an asset may not be
recovered.
F-33
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Recoverability of these assets is assessed based on undiscounted
expected future cash flows from the assets, considering a number
of factors, including past operating results, budgets and
economic projections, market trends, and product development
cycles. An impairment in the carrying value of each asset is
assessed when the undiscounted expected future cash flows
derived from the asset are less than its carrying value.
During 2003, the Company generated revenue from licensing
software and databases used to support the discovery and
development of new drugs. The Company recognizes revenue on the
licensing of its software products and sales of related services
in accordance with the American Institute of Certified Public
Accountants Statement of Position (SOP) No. 97-2,
Software Revenue Recognition
(SOP 97-2), as
amended by SOP No. 98-9, Software Revenue Recognition,
with Respect to Certain Arrangements (SOP 98-9).
Revenue from these arrangements are recognized ratably over the
term of the contract.
The Company recognizes revenue relating to collaborations in
accordance with the Securities and Exchange Commissions
Staff Accounting Bulletin (SAB) No. 104, Revenue
Recognition in Financial Statements (SAB 104) and
Emerging Issues Task Force 00-21 Accounting for Revenue
Arrangements with Multiple Deliverables
(EITF 00-21).
Revenue under collaborations may include the receipt of
non-refundable license fees, milestones payment, royalties and
research and development payments.
The Company recognizes nonrefundable upfront license fees and
guaranteed, time-based payments that require continuing
involvement in the form of research and development as revenue:
|
|
|
|
|
Ratably over the development period if development risk is
significant; or |
|
|
|
Based upon the level of research services performed during the
period of the research contract. |
When the period of deferral cannot be specifically identified
from the contract, management estimates the period based upon
other critical factors contained within the contract. The
Company continually reviews such estimates which could result in
a change in the deferral period and might impact the timing and
amount of revenue recognized.
Milestone payments are recognized as revenue when the
performance obligations, as defined in the contract, are
achieved. Performance obligations typically consist of
significant milestones in the development life cycle of the
related technology, such as initiation of clinical trials,
filing of approval with regulatory agencies and approvals by
regulatory agencies.
Royalties are recognized as revenue when earned.
Reimbursements of research and development costs are recognized
as revenue as the related costs are incurred.
The Company accounts for research and development costs in
accordance with Statement of SFAS No. 2, Accounting
for Research and Development Costs, which requires that
expenditures be expensed to operations as incurred. Research and
development expenses comprise costs incurred in performing
research and development activities, including salaries and
benefits, facilities costs, overhead costs, clinical trial
costs, contract services, and other outside costs.
Pursuant to SFAS No. 109, Accounting for Income
Taxes, the liability method is used to account for income
taxes. Deferred tax assets and liabilities are determined based
on differences between financial
F-34
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
reporting and income tax basis of assets and liabilities, as
well as net operating loss carryforwards, and are measured using
the enacted tax rates and laws that will be in effect when the
differences reverse. Deferred tax assets are reduced by a
valuation allowance to reflect the uncertainty associated with
their ultimate realization.
The financial statements of the Companys Israeli
subsidiary, Predix Limited, are measured using the
U.S. dollar as the functional currency. Accordingly,
monetary accounts maintained in New Israeli Shekels are
re-measured to U.S. dollars using the foreign exchange rate
at the balance sheet date. Operational accounts and non-monetary
balance sheet accounts are measured and recorded at the exchange
rate in effect at the date of the transaction. Adjustments
resulting from the re-measurement process are made to income.
For the years ended December 31, 2003, 2004 and 2005, the
re-measurement process resulted in transaction gains of
approximately, $16,000, $3,000 and $11,000, respectively.
Comprehensive loss comprises net loss and unrealized gains and
losses on available for sale securities. Comprehensive loss is
reflected in the consolidated statements of stockholders
equity.
The Company follows the intrinsic value method under Accounting
Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees (APB 25) and related
interpretations, in accounting for its stock-based compensation
plans, rather than the alternative fair value accounting method
provided for under SFAS No. 123, Accounting for
Stock-Based Compensation (SFAS No. 123), as
amended by SFAS No. 148, Accounting for Stock-based
Compensation Transition and Disclosure,
(SFAS No. 148). Under APB 25, when the exercise
price of options granted is less than or equals the market price
of the underlying stock on the date of grant, no compensation
expense is recognized. In accordance with Emerging Issues Task
Force (EITF) 96-18, the Company records compensation
expense equal to the fair value of options granted to
non-employees over the vesting period, which is generally the
period of service.
The following table illustrates the effect on net loss and loss
per share if the Company had applied the fair value recognition
provisions of SFAS No. 123 to stock-based employee
compensation (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Net loss
|
|
$ |
(33,703 |
) |
|
$ |
(19,392 |
) |
|
$ |
(24,560 |
) |
Add: stock-based employee compensation as reported in the
statement of operations
|
|
|
527 |
|
|
|
|
|
|
|
664 |
|
Deduct: total stock-based employee compensation expense
determined under fair value based method for all awards
|
|
|
(1,331 |
) |
|
|
(427 |
) |
|
|
(82 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(34,507 |
) |
|
$ |
(19,819 |
) |
|
$ |
(23,978 |
) |
|
|
|
|
|
|
|
|
|
|
The weighted-average per share fair value of options granted
during 2005, 2004 and 2003 was $2.70, $0.54 and $1.26,
respectively.
F-35
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The fair value of stock options and common stock issued pursuant
to the stock option at the date of grant were estimated using
the Black-Scholes model with the following weighted-average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Expected life (years)
|
|
|
4.44 |
|
|
|
3.84 |
|
|
|
5.58 |
|
Interest rate
|
|
|
3.9% |
|
|
|
3.2% |
|
|
|
3.6% |
|
Volatility
|
|
|
80% |
|
|
|
80% |
|
|
|
80% |
|
The expected volatility factor was based on public small
capitalization stocks with significant risk (scientific or
otherwise), which tend to have a relatively high volatility.
The Black-Scholes model was developed for use in estimating the
fair value of traded options, which have no vesting restrictions
and are fully transferable. Option valuation models require the
input of highly subjective assumptions including the expected
stock price volatility. The Companys employee stock
options have characteristics significantly different from those
of traded options and changes in the subjective inputs
assumptions can materially affect the fair value estimate.
The Company has never declared cash dividends on any of its
capital stock and does not expect to do so in the foreseeable
future.
|
|
|
Accounting Pronouncements |
In December 2004, the FASB issued SFAS No. 123R
(revised 2004), Share-Based Payment An Amendment
of FASB Statements No. 123 and 95
(SFAS No. 123R). SFAS No. 123R requires
companies to calculate and record in the income statement the
cost of equity instruments, such as stock options or restricted
stock, awarded to employees for services received. The cost of
the equity instrument is to be measured based on the fair value
of the instruments on the date they are granted and is required
to be recognized over the period during which the employees are
required to provide services in exchange for the equity
instruments. SFAS No. 123R is effective at the
beginning of the first interim period beginning after
June 15, 2005.
SFAS No. 123R provides two alternatives for adoption:
|
|
|
|
|
a modified prospective method in which compensation cost is
recognized for all awards granted subsequent to the effective
date of the statement as well as for the unvested portion of
awards outstanding as of the effective date; or |
|
|
|
a modified retrospective method which follows the approach in
the modified prospective method, but also permits entities to
restate prior periods to record compensation cost calculated
under SFAS No. 123 for pro forma disclosure. |
The Company plans to adopt SFAS No. 123R using the
modified prospective method. As permitted by
SFAS No. 123, the Company currently accounts for
share-based payments to employees using APB 25 intrinsic
value method and, as such, generally recognizes no compensation
cost for employee stock options. Accordingly, the adoption of
SFAS No. 123Rs fair value method will have a
significant impact on the Companys result of operations,
although it will have no impact on its overall financial
position. The Company cannot accurately estimate at this time
the impact of adopting SFAS No. 123R as it will depend
on market price, assumptions used and levels of share-based
payments granted in future periods. However, had the Company
adopted SFAS No. 123R in a prior period, the impact
would approximate the impact of SFAS No. 123 as
described in the disclosure of pro forma net loss and net loss
per share noted in the Stock-Based Compensation Note.
F-36
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2004 and 2005, the Company held
$0.7 million and $0.9 million in restricted cash,
respectively. The balances comprise amounts held in deposit with
certain banks to collateralize standby letters of credit in the
name of the landlord in accordance with the facility lease
agreement.
|
|
4. |
Property and equipment |
Property and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Laboratory equipment
|
|
$ |
854 |
|
|
$ |
780 |
|
Computer equipment and software
|
|
|
1,307 |
|
|
|
926 |
|
Leasehold improvements
|
|
|
159 |
|
|
|
164 |
|
Furniture and fixtures
|
|
|
452 |
|
|
|
248 |
|
|
|
|
|
|
|
|
|
|
|
2,772 |
|
|
|
2,118 |
|
Less accumulated depreciation and amortization
|
|
|
(1,373 |
) |
|
|
(1,043 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,399 |
|
|
$ |
1,075 |
|
|
|
|
|
|
|
|
Depreciation expense for the years ended December 31, 2005,
2004 and 2003 was $0.4 million, $0.3 million and
$1.4 million, respectively.
Accrued expenses consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Payroll and benefits
|
|
$ |
200 |
|
|
$ |
112 |
|
Vacation
|
|
|
219 |
|
|
|
195 |
|
Accrued purchases
|
|
|
474 |
|
|
|
318 |
|
Clinical trial costs
|
|
|
3,744 |
|
|
|
913 |
|
|
|
|
|
|
|
|
|
|
$ |
4,637 |
|
|
$ |
1,538 |
|
|
|
|
|
|
|
|
Effective August 8, 2003, the Company acquired the entire
outstanding shares of common stock and preferred stock of Predix
Pharmaceuticals Ltd. in exchange for 3,400 shares of common
stock, valued at $18.00 per share, 7,341 shares of
newly created Class A common stock, valued at
$18.00 per share and 759,682 shares of preferred
stock, valued at $10.00 per share, pursuant to a Stock
Purchase Agreement, dated July 1, 2003, by and among the
Company, Predix Pharmaceuticals Ltd., an unrelated corporation
formed under the laws of Israel, Predix Pharmaceuticals, Inc., a
Delaware corporation and a wholly owned subsidiary of Predix
Limited. (Predix Inc., and together with Predix Limited, Predix)
and certain individuals and entities.
The purchase price of $7.7 million was funded with the
common and preferred stock of the Company. The acquisition of
Predix Limited. was accounted for using the purchase method of
accounting and the operations of Predix are included in the
Consolidated Statements of Operations from the date of
acquisition. The purchase price was allocated to the net
tangible assets acquired (primarily current assets
F-37
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
of $1.0 million, property and equipment of
$0.8 million, deposits of $0.1 million, and current
liabilities of $0.9 million) and $6.7 million was
charged to operating expenses pursuant to FIN 4. As Predix
Limited was a development stage enterprise at the time of the
acquisition, as defined in SFAS No. 7, no goodwill was
recorded.
The Company did not obtain a formal valuation of the in-process
technology at the time of the acquisition.
Pursuant to the SFAS No. 146, Accounting for Costs
Associated with Exit or Disposal Activities, the Company
recorded restructuring charges in 2003 of approximately
$5.4 million, which included $1.5 million for the
future lease rental (net of sublease income) related to its
Princeton, NJ office, $2.1 million of excess property and
equipment written off, and $1.8 million related to
severance for 57 employees, which was paid out during 2003. At
December 31, 2005, 2004 and 2003 restructuring liabilities
were $1.3 million, $1.3 million and $1.5 million,
respectively, for the future lease rental (net of sublease
income) related to its Princeton, New Jersey office. The
following table displays the restructuring activity and
liability balances (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at | |
|
|
|
|
|
Balance at | |
|
|
|
|
|
Balance at | |
|
|
December 31, | |
|
2004 | |
|
|
|
December 31, | |
|
2005 | |
|
|
|
December 31, | |
|
|
2003 | |
|
Payments | |
|
Other | |
|
2004 | |
|
Payments | |
|
Other | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Princeton, NJ Lease
|
|
$ |
1,503 |
|
|
$ |
(294 |
) |
|
$ |
78 |
|
|
$ |
1,287 |
|
|
$ |
(268 |
) |
|
$ |
242 |
|
|
$ |
1,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,503 |
|
|
$ |
(294 |
) |
|
$ |
78 |
|
|
$ |
1,287 |
|
|
$ |
(268 |
) |
|
$ |
242 |
|
|
$ |
1,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company leases its facilities in Lexington, MA and
Princeton, NJ, and facilities and vehicles in Ramat Gan, Israel
under agreements, which are accounted for as operating leases.
The facility leases generally provide for a base rent plus real
estate taxes and certain operating expenses related to the
leases. Rent expense amounted to approximately
$0.6 million, $0.4 million and $1.4 million for
the years ended December 31, 2005, 2004 and 2003,
respectively. Certain of the Companys leases contain
renewal options and escalating payments over the life of the
lease. As discussed in Note 7, the Company has vacated its
Princeton, NJ office.
The Company leases certain equipment under capital lease
agreements. The Company has assets under capital lease
obligations amounting to $0.5 million and $0.4 million
as of December 31, 2005 and 2004, respectively.
Amortization of such equipment is included in depreciation
expense The equipment leases bear interest at 9.7% per year.
F-38
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2005, future minimum commitments under all
noncancelable capital and operating leases with initial or
remaining terms of more than one year are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Capital | |
|
Operating | |
|
|
Leases | |
|
Leases | |
|
|
| |
|
| |
2006
|
|
$ |
105 |
|
|
$ |
1,398 |
|
2007
|
|
|
51 |
|
|
|
1,497 |
|
2008
|
|
|
38 |
|
|
|
1,602 |
|
2009
|
|
|
32 |
|
|
|
1,602 |
|
2010
|
|
|
7 |
|
|
|
1,627 |
|
Thereafter
|
|
|
|
|
|
|
1,707 |
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
|
233 |
|
|
|
9,433 |
|
Less aggregate future sublease income
|
|
|
|
|
|
|
(3,068 |
) |
|
|
|
|
|
|
|
|
|
|
233 |
|
|
$ |
6,365 |
|
|
|
|
|
|
|
|
Less amount representing interest
|
|
|
(35 |
) |
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments
|
|
|
198 |
|
|
|
|
|
Less current portion of capital lease obligation
|
|
|
(89 |
) |
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations, net of current portion
|
|
$ |
109 |
|
|
|
|
|
|
|
|
|
|
|
|
The operating lease payments in the above table include
$4.7 million for the Companys abandoned facility in
Princeton, NJ. These amounts have been accrued at
December 31, 2005 and 2004 (and exclude sublease income of
$3.1 million) as lease abandonment liability. Also included
in the operating lease payments in the above table is
$4.7 million of future rental payments relating to a
facilities lease the Company entered into during 2004 for its
primary office space in Lexington, Massachusetts. This
facilities lease commenced in 2005 and has a term of seven
years. The Lexington lease is renewable for two additional
periods of three years each at the Companys option.
For its facilities in Ramat Gan, Israel, the Company has
provided guaranties for the fulfillment of its lease commitments
totaling $0.04 million.
In March 2005, the Company and Cystic Fibrosis Foundation
Therapeutics Incorporated (CFFT), the drug discovery
and development affiliate of the Cystic Fibrosis Foundation,
entered into a three year research, development and
commercialization agreement. Under this agreement, the Company
received an upfront payment of $2.0 million and can receive
cost reimbursements and milestone payments. The agreement covers
two research programs and has a term of three years. CFFT may
terminate either or both programs without cause upon
120 days notice.
The Company is recognizing the $2.0 million upfront payment
as revenue ratably over the three-year term. The reimbursements
of research and development costs are being recognized as
revenue as the related costs are incurred. As the Company is the
party responsible for providing the research services, the
Company is recognizing the reimbursements of the costs
associated with its research efforts as revenue, not as a net
research expense. The Company will recognize any milestone
payments as revenue when the related performance obligation, as
defined in the agreement, is achieved.
During 2005, the Company has recognized $2,293,000 in revenue
from this collaboration, $556,000 relating to the
$2.0 million upfront payment and $1,737,000 from reimbursed
research services and costs.
F-39
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Effective August 8, 2003, the Company amended and restated
its certificate of incorporation to amend, among other things,
the following to: (i) change its name to Predix
Pharmaceuticals Holdings, Inc.; (ii) provide for a
one-for-17.971067
reverse stock split of the Companys Existing Common Stock;
(iii) create a new class of Class A Common Stock;
(iv) reclassify and convert the outstanding shares of the
Companys Series A convertible preferred stock,
Series B convertible preferred stock and Series C
convertible preferred stock into shares of a newly created class
of Series A convertible preferred stock and delete all
references to such prior preferred classes; (v) reclassify
and convert the outstanding shares of the Companys
Series D convertible preferred stock into shares of a newly
created class of Series B convertible preferred stock and
delete all references to such prior preferred class; and
(iv) designate the newly created Series A convertible
preferred stock and Series B convertible preferred stock.
All shares and per share data for all periods presented in these
financial statements have been adjusted to reflect the reverse
stock split.
There was no beneficial conversion feature in any of the
following transactions as the value of the preferred stock on an
as-converted basis was greater than the estimated fair value of
the underlying common stock into which it was convertible.
On August 8, 2003, in connection with the recapitalization
of the Companys capital stock mentioned above, the Company
issued the following securities:
|
|
|
|
|
An aggregate of 480,552 shares of a newly created
Series A convertible preferred stock and an aggregate of
1,291,991 shares of a newly created Series B
convertible preferred stock to its existing stockholders in
exchange for an aggregate of 2,187,250 shares of its then
outstanding Series A convertible preferred stock, an
aggregate of 6,060,606 shares of its then outstanding
Series B convertible preferred stock, an aggregate of
2,568,371 shares of its then outstanding Series C
convertible preferred stock and an aggregate of
10,438,413 shares of its then outstanding Series D
convertible preferred stock. Each share of newly created
Series A convertible preferred stock and newly created
Series B convertible preferred stock was convertible into
0.5556 shares of common stock. |
|
|
|
Warrants to all of the Companys stockholders that entitled
the holder to purchase its pro rata share of an aggregate of
1,000,000 shares of its newly created Series B
convertible preferred stock. |
Effective August 9, 2004, the Company amended and restated
its certificate of incorporation to amend, among other things,
the following to: (i) reclassify and convert each
outstanding share of the Companys New Common Stock and the
Companys Class A Common Stock into one fully paid and
nonassessable share of the Companys common stock, par
value $0.01; (ii) increase the Companys authorized
capital stock from 47,600,000 to 547,866,045, of which
309,642,245 shall be common stock, and 238,223,800 shall be
preferred stock, par value $0.01 per share;
(iii) create and designate 76,800,000 shares of
Series AB convertible preferred stock, par value
$0.01 per share; and (iv) create and designate
158,823,800 shares of Series C convertible preferred
stock, par value $0.01 per share.
On August 9, 2004, in connection with an equity financing
and the recapitalization of the Companys capital stock, it
issued the following securities:
|
|
|
|
|
An aggregate of 66,753,820 shares of its Series C
convertible preferred stock to existing investors at a purchase
price of $0.22037 per share for an aggregate purchase price
of $14,710,539. Shares of Series C convertible preferred
stock are convertible on a
1-for-18 basis into
shares of the Companys common stock. |
|
|
|
An aggregate of 14,531,460 shares of its Series AB
convertible preferred stock and warrants to purchase an
aggregate of 62,240,212 shares of its Series AB
convertible preferred stock to existing stockholders in exchange
for an aggregate of 732,347 shares of its newly created
Series A |
F-40
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
convertible preferred stock and an aggregate of
720,799 shares of its newly created Series B
convertible preferred stock. Each share of Series AB
convertible preferred stock in convertible into one share of the
Companys common stock. |
|
|
|
An aggregate of 599,488 shares of common stock to existing
stockholders in exchange for an aggregate of 335,623 shares
of its newly created Series A convertible preferred stock
and an aggregate of 743,456 shares of is newly created
Series B convertible preferred stock; and |
|
|
|
An aggregate of 20,638 shares of common stock to existing
stockholders in exchange for an aggregate of 20,638 shares
of the Companys Class A Common Stock. |
Between September 9, 2004 and January 21, 2005, the
Company issued an aggregate of 115,740,536 shares of its
Series C convertible preferred stock to investors at a
purchase price of $0.22037 per share for an aggregate
purchase price of $25,505,742.
On September 21, 2004, the Company issued
1,146,892 shares of its Series AB convertible
preferred stock upon the exercise of a warrant to an existing
stockholder for an aggregate purchase price of $11,469.
In January 2005, the Company completed a private equity funding
round raising total net proceeds of $43.0 million and
issuing 196,431,820 shares of Series C Convertible
Preferred Stock, which includes net proceeds of
$21.9 million and 100,160,121 shares sold in 2004.
On January 17, 2005, the Company issued an aggregate of
12,125,825 shares of its Series C convertible
preferred stock upon the exercise of warrants to existing
stockholder investors for an aggregate purchase price of
$2,672,168.
Effective January 21, 2005, the Company amended and
restated its certificate of incorporation to amend, among other
things, the following to: (i) increase the Companys
authorized capital stock from 547,866,045 to 599,998,740, of
which 324,700,000 shall be.
Common Stock and 275,298,740 shall be Preferred Stock, par value
$0.01 per share; (ii) designate 76,771,672 shares
of Series AB Convertible Preferred Stock, par value
$0.01 per share; (iii) designate
198,527,068 shares of Series C Convertible Preferred
Stock, par value $0.01 per share.
On March 7, 2005, the Company issued an aggregate of
1,811,640 shares of its Series C convertible preferred
stock upon the exercise of warrants to existing stockholder
investors for an aggregate purchase price of $399,231.
Effective April 26, 2005, the Company amended and restated
its certificate of incorporation to amend, among other things,
the following to: (i) increase the Companys
authorized capital stock from 599,998,740 to 613,384,553, of
which 338,085,813 shall be Common Stock and 275,298,740 shall be
Preferred Stock, par value $0.01 per share;
(ii) designate 76,771,672 shares of Series AB
Convertible Preferred Stock, par value $0.01 per share; and
(iii) designate 198,527,068 shares of Series C
Convertible Preferred Stock, par value $0.01 per share.
Between August 18, 2005 and October 21, 2005, the
Company issued an aggregate of 61,093,320 shares of its
Series AB convertible preferred stock upon the exercise of
warrants to existing stockholder investors for an aggregate
purchase price of $610,933.
In September 2005, the board of directors and stockholders
approved a 1-for-18
reverse stock split of the outstanding shares of common stock
and an adjusted conversion ratio of Series C and
Series AB convertible preferred stock to reflect the
1-for-18 reverse stock
split of the common stock.
F-41
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Convertible Preferred Stock
Authorized and outstanding convertible preferred stock and its
principal terms are as follows at December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
Shares | |
|
|
| |
|
|
|
|
Issued and | |
Series |
|
Authorized | |
|
Outstanding | |
|
|
| |
|
| |
AB
|
|
|
76,771,672 |
|
|
|
76,771,672 |
|
C
|
|
|
198,527,068 |
|
|
|
196,431,820 |
|
|
|
|
|
|
|
|
|
|
|
275,298,740 |
|
|
|
273,203,492 |
|
|
|
|
|
|
|
|
The holders of the Convertible Preferred Stock (AB and C)
(collectively, the Preferred Stock) have the
following rights:
Dividends
The holders of the Preferred Stock are entitled to receive
non-cumulative dividends when and if declared by the board of
directors. The holders of the Series C preferred stock are
entitled to receive, when declared by the board of directors,
non-cumulative dividends at the annual rate of 8% of the
Series C purchase price. These dividends to holders of the
Series C preferred stock, if declared, are in preference
and priority to any declaration or payment of any dividend on
the Series AB preferred stock and common stock of the
Company. As of December 31, 2005, no dividends have been
declared.
Liquidation
In the event of any liquidation, the holders of the
Series C preferred stock have a liquidation preference over
holders of Series AB preferred stock and Common Stock,
which is an amount per share plus any declared but unpaid
dividends. In the event of any liquidation, dissolution, or
winding up of the Company (excluding a consolidation, merger or
reorganization of the corporation), following payment of the
Series C preferred stock preference, the holders of the
Series AB preferred stock have a liquidation preference
over holders of Common Stock. After payment of the Series C
preference and Series AB preference, the entire remaining
assets and funds of the Corporation legally available for
distribution shall be distributed pro rata among all holders of
the Series C preferred stock, the Series AB preferred
stock and Common Stock (treating all holders of Preferred Stock
as holders of Common Stock on an if-converted to Common Stock
basis).
Conversion
Each share of the Preferred Stock is convertible at the
holders option into the number of common shares as
determined by the applicable conversion rate. The initial
conversion rate for each share of Series C and
Series AB preferred stock has been set at one share of
Common Stock for each share of Series C and Series AB
preferred stock, respectively, subject to any stock dividend,
stock split, combination, reorganization, or other
recapitalization. Upon the
1-for-18 revenue stock
split in September 2005, the conversion rate for each share of
Series C and Series AB preferred stock has been set at
one share of Common Stock for eighteen shares of Series C
and Series AB preferred stock, respectively. Each share of
Preferred Stock will be automatically converted into common
stock based at the then applicable conversion rate, upon
(a) closing of an underwritten initial public offering of
the common stock pursuant to an effective registration, in which
the aggregate gross proceeds to the Company are at least
$40.0 million (prior to the deduction of underwriters
commissions, discounts, and expenses) and at a pre-money
valuation of the Company of no less than $135.0 million or
(b) a date agreed to in writing by the
F-42
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
holders of at least 60% of the voting power of the then
outstanding shares of Preferred Stock and the holders of at
least
662/3
% of the voting power of the then outstanding shares of
Series C preferred stock. The holders of the Preferred
Stock are entitled to the number of votes equal to the number of
shares of common stock into which their preferred stock is
convertible.
Voting
The holders of the Preferred Stock are entitled to the number of
votes equal to the number of common shares into which they are
convertible.
Common stock
During the year 2000, an officer of the Company, purchased
69,722 and 8,343 shares of the Companys restricted
common stock at $8.82 and $11.70 per share, respectively,
the then-current fair value per share. The officer paid for the
69,722 shares by paying $0.01 million in cash and
issuing a $0.6 million promissory note that bears interest
at 6.4% per annum. The officer paid for 8,343 shares
by paying $0.02 million in cash and issuing a
$0.07 million promissory note that bears interest at
6.33% per annum. The officer had the right to repay the
notes by returning shares of the restricted common stock to the
Company. For purposes of repayment of the $0.6 million
promissory note, each share returned was to be valued at the
greater of $6.62 or the then-current fair market value. For
purposes of repayment of the $0.07 million promissory note,
each share returned was to be valued at the greater of $8.78 or
the then-current fair market value. The Company had the right to
repurchase a certain number of these shares at the respective
prices paid by the officer. This right lapsed ratable over a
34-month period
beginning January 2000. As a result of the terms of the
promissory notes issued in connection with these transactions,
the Company accounted for these arrangements as variable awards
under EITF Issue
No. 95-16,
Accounting for Stock Compensation Arrangements With Employer
Loan Features Under APB Opinion No. 25
(EITF 95-16). The Company recorded noncash compensation
expense of $0.1 million during 2000 based on the fair value
of the common stock of $11.70 as of December 31, 2000. This
expense was reduced by $1,829 during 2001 and by
$0.1 million during 2002 based on the fair value of the
common stock of $11.70 and $0.80 as of December 31, 2001
and 2002, respectively. In October 2002, the officer requested
that the Company repurchase 66,210 of his shares as payment
of the two outstanding promissory notes. The board of directors
of the Company approved the transaction in 2003. The Company
purchased the shares from the officer and canceled them in 2003.
The Company recorded noncash compensation expense of
$0.7 million during 2003 with respect to the transaction.
2003 Stock Plan
The Company has a 2003 Stock Incentive Plan (the 2003
Plan), which provides for the granting of stock awards.
Stock options may be granted under the 2003 Plan either as
options intended to qualify as incentive stock options (ISOs)
under the Internal Revenue Code or as nonqualified stock options
(NQs). Also, the Company may grant rights to acquire restricted
stock and other stock awards based upon the common stock having
such terms and conditions as the Board may determine. Under the
2003 Plan, stock awards may be granted to employees (including
officers and directors who are employees) and to consultants of
the Company (NQs, restricted stock, and other stock awards
only). The options may be granted at a price not less than par
value of the common stock on the date of grant. The board of
directors determines the vesting schedule of the awards. At
December 31, 2005, the Company had a total of
120,356 shares of Common Stock available for grant under
the 2003 Plan.
F-43
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
A summary of stock option activity related to employee stock
options for the period from January 1, 2003 through
December 31, 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
|
Average | |
|
|
|
Average | |
|
|
|
Average | |
|
|
|
|
Exercise | |
|
|
|
Exercise | |
|
|
|
Exercise | |
|
|
Shares | |
|
Price | |
|
Shares | |
|
Price | |
|
Shares | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Outstanding at January 1
|
|
|
1,407,396 |
|
|
$ |
0.96 |
|
|
|
160,994 |
|
|
$ |
1.80 |
|
|
|
101,619 |
|
|
$ |
9.36 |
|
Granted
|
|
|
1,256,346 |
|
|
|
1.11 |
|
|
|
1,278,025 |
|
|
|
0.85 |
|
|
|
181,267 |
|
|
|
1.80 |
|
Exercised
|
|
|
(381,469 |
) |
|
|
0.85 |
|
|
|
(28,577 |
) |
|
|
0.84 |
|
|
|
(12,492 |
) |
|
|
1.80 |
|
Canceled/forfeited
|
|
|
(42,262 |
) |
|
|
1.02 |
|
|
|
(3,046 |
) |
|
|
1.80 |
|
|
|
(109,400 |
) |
|
|
8.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31
|
|
|
2,240,011 |
|
|
|
1.06 |
|
|
|
1,407,396 |
|
|
|
0.96 |
|
|
|
160,994 |
|
|
|
1.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31
|
|
|
877,038 |
|
|
|
0.95 |
|
|
|
829,726 |
|
|
|
0.91 |
|
|
|
54,745 |
|
|
|
1.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about stock options
outstanding and exercisable at December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
|
|
|
|
|
Average | |
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
|
Remaining | |
|
Average | |
|
|
|
Average | |
Range of Exercise |
|
|
|
Contractual | |
|
Exercise | |
|
|
|
Exercise | |
Prices |
|
Number | |
|
Life (Years) | |
|
Price | |
|
Number | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.81
|
|
|
1,644,839 |
|
|
|
8.92 |
|
|
$ |
0.81 |
|
|
|
741,233 |
|
|
$ |
0.81 |
|
1.44
|
|
|
381,680 |
|
|
|
9.41 |
|
|
|
1.44 |
|
|
|
29,203 |
|
|
|
1.44 |
|
1.80
|
|
|
183,659 |
|
|
|
7.55 |
|
|
|
1.80 |
|
|
|
106,602 |
|
|
|
1.80 |
|
5.40
|
|
|
29,833 |
|
|
|
9.76 |
|
|
|
5.40 |
|
|
|
|
|
|
|
5.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,240,011 |
|
|
|
|
|
|
|
|
|
|
|
877,038 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In connection with the acquisition of Predix Pharmaceuticals
Ltd. discussed in Note 1, the Company resolved to reprice
all stock options granted to the former Physiome employees,
resulting in the exercise price of options granted prior to that
date being reduced to $1.80 per share from $9.36 per
share.
The repricing of the options constituted a modification of an
award under the FASBs Financial Accounting Interpretation
No. 44, Accounting for Certain Transactions involving
Stock Compensation an interpretation of APB Opinion No. 25
(FIN 44), with an effective date of August 8,
2003. A calculation representing the intrinsic value of the
modification in accordance with FIN 44 did not result in an
expense during 2003 on the basis of managements
determination that the fair value of the common stock continued
to be $1.80 per share at December 31, 2003. As of
December 31, 2005, the remaining repriced options, 1,575
options, are being accounted for as variable options until such
options are exercised, forfeited, or expire unexercised.
In September 2005, the Company determined to assess
retrospectively the pricing of all options granted since January
2004.
The significant factors, assumptions, and methodologies used
in determining fair value are as follows: determining the
fair value of the Companys stock requires making complex
and subjective judgments. The Company used the income approach
to estimate the value of the enterprise at each date on which
options were granted. The income approach involves applying
appropriate discount rates to estimated cash flows that are
based on forecasts of revenue and costs. There is inherent
uncertainty in these estimates. The
F-44
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
assumptions underlying the estimates are consistent with the
Companys business plan. The risks associated with
achieving our forecasts were assessed in selecting the
appropriate discount rates. If different discount rates had been
used, the valuations would have been different.
The enterprise value was then allocated to preferred and common
stock using the option-pricing method. The option-pricing method
involves making estimates of the anticipated timing of a
potential liquidity event such as a sale of the Company or an
initial public offering, and estimates the volatility of the
Companys equity securities. The anticipated timing is
based on the plans of the Companys board and management.
Estimating the volatility of the share price of a privately held
company is complex because there is no readily available market
for the shares. The Company estimated the volatility of its
stock based on available information on volatility of stocks of
publicly traded companies in the industry. Had the Company used
different estimates of volatility, the allocations between
preferred and common shares would have been different.
As a result of this assessment, the Company determined certain
options granted in 2005 were issued at exercise prices below
fair value. The Company recorded approximately $2.8 million
of deferred compensation in stockholders equity and
$0.5 million in compensation expense relating to these
stock options granted to employees from January 1, 2005
through December 31, 2005. The amount of deferred
compensation for each option grant during the period was
calculated based upon the difference between the fair value of
the common stock at the date of grant and the option exercise
price. The Company determined all options granted prior to
January 1, 2005 were granted at fair value and no
compensation expense was recorded for these option grants.
The following options were granted at exercise prices below the
deemed fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise | |
|
Fair | |
Date |
|
Options | |
|
Price | |
|
Value | |
|
|
| |
|
| |
|
| |
April 2005
|
|
|
257,482 |
|
|
$ |
0.81 |
|
|
$ |
5.04 |
|
April 2005
|
|
|
229,146 |
|
|
|
1.44 |
|
|
|
5.04 |
|
May 2005
|
|
|
42,778 |
|
|
|
0.81 |
|
|
|
5.94 |
|
July-August 2005
|
|
|
149,096 |
|
|
|
1.44 |
|
|
|
5.94 |
|
August 2005
|
|
|
35,349 |
|
|
|
1.44 |
|
|
|
8.10 |
|
Of the 1,256,346 options granted in 2005, 713,851 options
were granted at exercise prices below their deemed fair value.
The weighted average exercise price and fair value per share of
the options was $1.18 and $5.43, respectively. The remaining
542,495 options were granted at $0.81 per share which
equals their fair value.
Deferred compensation is equal to the difference in the exercise
price and fair value, or the intrinsic value, and has been
recorded for all options granted below fair value. The deferred
compensation is being amortized as compensation expense over the
vesting period of the stock options, which is generally four
years.
Stock Options to Nonemployees
In 2004 and 2003, the Company issued 27,777 and 14,444 stock
options at a price of $0.81 and $1.80 per share,
respectively to non-employees in exchange for services. Vesting
for these shares ranges from on the date of grant to over a
period of four years. The Company has applied the recognition
provisions of SFAS 123 and EITF 96-18, Accounting
for Equity Instruments that are Issued to Other than Employees
for Acquiring, or in Connection with Selling Goods or Services
(EITF 96-18), related to these grants. As a result,
variable plan accounting has been applied to these grants. The
fair value of these options at December 31, 2005,
December 31, 2004 and December 31, 2003 was $5.40,
$0.81 and $1.80, respectively
F-45
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
per share. The Company recorded compensation charges related to
these grants of $0.02 million in 2003 on an accelerated
basis consistent with FASBs Financial Accounting
Interpretation No. 28, Accounting for Stock
Appreciation Rights and Other Variable Stock Option or Awards
Plans. No compensation was recorded in 2004 or 2005 related
to the 2003 grants as the change in the fair value was
insignificant. There was also no compensation charge recorded
related to the 2004 option grants in 2004 or 2005 as they were
issued at a price per share above the deemed market value at
December 31, 2004 and were subsequently exercised. In
computing the fair value of these options, the fair value of
each option grant is estimated as of the date of grant using the
Black-Scholes option-pricing model with the following
weighted-average assumptions used: a risk-free rate of return of
4% for the 2003 grants respectively and an expected option life
of 10 years (the contractual life of the options), no
dividends, and a stock volatility of 80% for grants in that
period.
Warrants
At December 31, 2005, the Company had outstanding
exercisable warrants to purchase 13,448 shares of
Common Stock with a weighted-average exercise price of
$31.37 per share, which expires through 2014.
Common Stock Reserved for Future Issuance
|
|
|
|
|
|
|
2005 | |
|
|
| |
Warrants
|
|
|
13,448 |
|
Common stock under the 2003 Plan
|
|
|
2,360,367 |
|
Common stock for conversion of Series C preferred stock
|
|
|
10,912,838 |
|
Common stock for conversion of Series AB preferred stock
|
|
|
4,265,060 |
|
|
|
|
|
|
|
|
17,551,713 |
|
|
|
|
|
|
|
11. |
Significant license agreement |
In September 2001, Predix Pharmaceuticals Ltd. signed a license
agreement with a University according to which the University
granted the Company a nontransferable, exclusive, worldwide
license to use the technology to develop, manufacture, market
and sell products, and to develop and provide services. In
consideration of the exclusive license agreement, the Company
paid the University a one-time license fee in the amount of
$0.04 million. In further consideration for the license,
the university will be entitled to royalties paid by the Company
at various rates from the proceeds received by the Company from
sales, provision of services, and sublicensing revenues
generated from the use of the licensed technology to the
Company. To date, the Company has received $2 million in
such revenues (in connection with the CFFT agreement, see
Note 9) and accordingly has paid $100,000 to the University
for such royalties.
As of December 31, 2005, the Company has domestic net
operating loss carryforwards and research and development credit
carryforwards of approximately $112.5 million and
$4.3 million, respectively, available to reduce future
federal and state income taxes, if any. If not utilized, these
carryforwards begin to expire in 2006 and expire through 2024.
Additionally, the Company has foreign net operating loss
carryforwards of $1.0 million available to offset future
income in foreign jurisdictions, if any. Such foreign net
operating losses have no expiration date. Recent transactions in
the Companys shares could result in an ownership change,
as defined in Section 382 of the Internal Revenue Code (the
Code). If such a change does occur, there could be annual
limitations on the amount of carryforwards, which can be
realized in future periods. The Company has not yet analyzed
these recent transactions in its shares to determine if any
limitation under Code Section 382 applies.
F-46
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The approximate income tax effects of each type of temporary
difference and carryforward at December 31 are as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net operating loss carryforwards
|
|
$ |
50,092 |
|
|
$ |
35,019 |
|
Research and development tax credit carry forwards
|
|
|
4,327 |
|
|
|
3,006 |
|
Capitalized research costs
|
|
|
1,356 |
|
|
|
1,969 |
|
Lease abandonment liability
|
|
|
508 |
|
|
|
518 |
|
Depreciation and amortization
|
|
|
1,928 |
|
|
|
1,988 |
|
Other temporary differences
|
|
|
119 |
|
|
|
102 |
|
Valuation allowance
|
|
|
(58,330 |
) |
|
|
(42,602 |
) |
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The Company has recorded a full valuation allowance against the
net deferred tax asset as of December 31, 2005 and 2004,
because the future realizability of such asset is uncertain. The
valuation allowance increased by $15.7 million during 2005
due primarily to a significant increase in net operating loss
carryforwards and a net increase in temporary items arising from
timing differences of costs for financial accounting and tax
purposes.
|
|
13. |
Defined contribution benefit plan |
The Company has adopted a 401(k) Plan (the 401(k) Plan) covering
all qualified employees. Participants may contribute up to 25%
of their annual compensation, subject to statutory limitations,
and the Company may declare discretionary matching contributions
to the 401(k) Plan. The Companys matching contribution for
the year ended December 31, 2003 totaled $2,000 and is
fully vested. The Company did not match any contributions for
the years ended December 31, 2005 and 2004.
On April 3, 2006, the Company announced the signing of a
definitive merger agreement whereby EPIX Pharmaceuticals
(EPIX) will acquire Predix in a transaction valued
at approximately $90 million, including the assumption of
net debt at closing. In addition, Predix shareholders will be
paid a possible milestone payment of $35 million in cash,
stock or a combination of both based on the achievement of
certain clinical or strategic milestones within a specified
period of time.
Under the terms of the agreement, which has been approved by the
Boards of Directors of both EPIX and Predix, upon the effective
time of the merger EPIX will issue to Predix stockholders shares
of EPIX common stock such that Predix stockholders will own
approximately 47% of the combined companys shares
outstanding, and EPIX stockholders will own approximately 53% of
the combined companys shares outstanding. Predix options
and warrants outstanding at closing will also be assumed by
EPIX. Predixs stockholders and option and warrant holders
will be entitled to a milestone payment of $35 million upon
Predixs achievement of certain clinical or strategic
milestones. At the option of the directors of EPIX, the
milestone payment may be paid in cash, stock or a combination of
both. In no event will the shares of EPIX common stock issuable
at the effective time of the merger, including the shares of
EPIX common stock issuable upon exercise of Predix options and
warrants assumed by EPIX in the merger, exceed 49.99% of the
outstanding EPIX common stock immediately after the effective
time of the merger. In addition, in no event may the milestone
be paid in shares of EPIX common stock to the extent that such
shares would exceed 49.99% of the outstanding shares of EPIX
common stock immediately after such milestone payment, when
combined with all shares of EPIX common stock issued in the
merger and
F-47
PREDIX PHARMACEUTICALS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
issuable upon exercise of all Predix options and warrants
assumed by EPIX in the merger. The transaction will be
structured as a tax-free exchange. The merger is subject to
approval by both EPIXs and Predixs stockholders,
regulatory approval and other closing conditions, and is
expected to close in June or July of 2006. Predix stockholders
holding approximately 40% of Predixs voting shares have
agreed to vote their shares in favor of the merger.
Upon closing, Predix stockholders will have the right to receive
1.248509 shares of EPIX stock for each share of Predix
common stock and preferred stock (on an as-converted basis) held
by them at the closing of the transaction. In connection with
the transaction, EPIX will issue approximately
23.275 million shares, including shares underlying
Predixs outstanding options and warrants.
On March 31, 2006, the Company entered into a bridge
financing agreement with certain of its shareholders. Under the
terms of this financing, the Company issued notes totaling
$9.5 million. The notes bear interest at 10% and are
payable in one year. In connection with these notes, the Company
issued 200,930 warrants to the note holders on a pro rata basis.
If the EPIX merger closes before August 1, 2006, the
warrants convert to 250,000 EPIX common shares on a pro rata
basis and the principal and accrued interest become payable one
month from the closing date. In the event the merger does not
close, the coupon increases from 10% to 15% and the notes become
convertible to Predix stock and the Company must issue
additional warrants to the note holders to increase the amount
of warrants issued to such shareholder to equal 20% of the
respective notes.
F-48
ANNEX A
AGREEMENT AND PLAN OF MERGER
BY AND AMONG
EPIX PHARMACEUTICALS, INC.,
EPIX DELAWARE, INC.
AND
PREDIX PHARMACEUTICALS HOLDINGS, INC.
Dated as of April 3, 2006
A-1
TABLE OF CONTENTS
A-2
A-3
A-4
|
|
|
Exhibit A
|
|
Form of Voting Agreement |
Exhibit B
|
|
Form of Certificate of Merger |
Exhibit C
|
|
Form of Predix Affiliate Agreement |
Exhibit D
|
|
Form of Lockup Agreement |
Exhibit E
|
|
Form of Opinion of Predixs Counsel |
Exhibit F
|
|
Form of Opinion of EPIXs Counsel |
Schedule 1
|
|
List of Predix Management for purpose of knowledge qualifiers |
Schedule 2
|
|
List of Key Predix Employees under Section 2.15 |
Schedule 3
|
|
List of EPIX Management for purpose of knowledge qualifiers |
Schedule 4
|
|
List of Key EPIX Employees under Section 3.20 |
Schedule 5
|
|
List of Predix Stockholders who are signatories to the Lockup
Agreement |
Schedule 6
|
|
Employees not entitled to severance payments and amount of
severance payments |
Schedule 7
|
|
List of Affiliate Stockholders for S-3 Registration
Statement |
Schedule 8
|
|
List of consents under Predix agreements to be obtained by
Predix as a condition to closing |
Schedule 9
|
|
Management |
Predix Disclosure Schedule |
EPIX Disclosure Schedule |
A-5
AGREEMENT AND PLAN OF MERGER
AGREEMENT AND PLAN OF MERGER, dated as of April 3, 2006
(the Agreement), among EPIX Pharmaceuticals,
Inc., a Delaware corporation (EPIX), EPIX
Delaware, Inc., a Delaware corporation and wholly-owned
subsidiary of EPIX (Merger Sub), and Predix
Pharmaceuticals Holdings, Inc., a Delaware corporation
(Predix).
RECITALS:
WHEREAS, the Boards of Directors of EPIX, Merger Sub and Predix
have each determined that it is advisable and in the best
interests of their respective stockholders for such parties to
enter into a business combination upon the terms and subject to
the conditions set forth herein;
WHEREAS, in furtherance of such combination, the Boards of
Directors of EPIX, Merger Sub and Predix have determined that it
is in the best interests of their respective corporations and
their stockholders to consummate the business combination
transaction provided for herein in which Predix will, in
accordance with the Delaware General Corporation Law
(Delaware Law) and subject to the terms and
conditions set forth herein, merge (the
Merger) with and into Merger Sub, with Merger
Sub referred to herein as the Surviving
Corporation and becoming a wholly-owned subsidiary of
EPIX;
WHEREAS, pursuant to the Merger, EPIX will acquire all of the
outstanding equity securities of Predix by way of merger of
Predix with and into Merger Sub and EPIX will issue not more
than 23,275,484 shares (subject to adjustment in accordance
with Section 1.7(e) of the Agreement) of common stock, par
value $.01 per share, of EPIX (the EPIX Common
Stock), to Predix (and cash in lieu of fractional
shares) in consideration for the Merger, with such shares to
include approximately 3,022,225 shares of EPIX Common Stock
subject to stock options and warrants of Predix outstanding on
the date of this Agreement;
WHEREAS, EPIX, Merger Sub and Predix intend, by approving
resolutions authorizing this Agreement, to adopt this Agreement
as a plan of reorganization within the meaning of
Section 368(a) of the Internal Revenue Code of 1986, as
amended (the Code), and the regulations
thereunder, and to cause the Merger to qualify as a
reorganization under the provisions of Section 368(a) of
the Code;
WHEREAS, as a condition to the willingness of, and an inducement
to EPIX to enter into this Agreement, contemporaneously with the
execution and delivery of this Agreement, stockholders of Predix
holding approximately forty percent (40%) of the voting shares
of Predix are entering into a voting agreement in substantially
the form of Exhibit A hereto (the Voting
Agreement); and
WHEREAS, EPIX, Merger Sub and Predix desire to make certain
representations and warranties and other agreements in
connection with the Merger and pursuant to the terms of this
Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual
covenants and agreements herein contained, EPIX, Merger Sub and
Predix hereby agree as follows:
ARTICLE I
THE MERGER
1.1. THE MERGER.
(a) Effective Time. At the Effective Time,
and subject to and upon the terms and conditions of this
Agreement and Delaware Law, Predix shall be merged with and into
Merger Sub, the separate corporate existence of Predix shall
cease, and Merger Sub shall continue as the Surviving
Corporation.
(b) Closing. Unless this Agreement shall have
been terminated and the transactions herein contemplated shall
have been abandoned pursuant to Section 7.1, and subject to
the satisfaction or waiver of the conditions set forth in
Article VI, the consummation of the Merger will take place
as promptly as practicable (and in any event within two
(2) business days) after satisfaction or waiver of the
conditions set forth in Article VI, at the offices of
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One
A-6
Financial Center, Boston, Massachusetts 02111, unless another
date, time or place is agreed to in writing by the parties
hereto (the Closing).
1.2. EFFECTIVE TIME. As
promptly as practicable after the satisfaction or waiver of the
conditions set forth in Article VI (and in any event within
two (2) business days), the parties hereto shall cause the
Merger to be consummated by filing a Certificate of Merger in
accordance with the relevant provisions of Delaware Law (the
Certificate of Merger), in substantially the
form of Exhibit B hereto, together with any required
related certificates, with the Secretary of State of the State
of Delaware, in such form as required by, and executed in
accordance with the relevant provisions of, Delaware Law (the
time of such filing being the Effective Time
and the date on which the Effective Time occurs shall be the
Effective Date).
1.3. EFFECT OF THE MERGER.
At the Effective Time, the effect of the Merger shall be as
provided in this Agreement, the Certificate of Merger and the
applicable provisions of Delaware Law. Without limiting the
generality of the foregoing, and subject thereto, at the
Effective Time all the property, rights, privileges, powers and
franchises of Predix shall vest in the Surviving Corporation,
and all debts, liabilities, obligations and duties of Predix
shall become the debts, liabilities, obligations and duties of
the Surviving Corporation.
1.4. CERTIFICATE OF
INCORPORATION; BYLAWS.
(a) Certificate of Incorporation. The
Certificate of Incorporation of Merger Sub, as in effect
immediately prior to the Effective Time, shall be the
Certificate of Incorporation of the Surviving Corporation until
thereafter amended as provided by Delaware Law and such
Certificate of Incorporation.
(b) Bylaws. The Bylaws of Merger Sub, as in
effect immediately prior to the Effective Time, shall be the
Bylaws of the Surviving Corporation until thereafter amended as
provided by Delaware Law, the Certificate of Incorporation of
the Surviving Corporation and such Bylaws.
1.5. DIRECTORS AND OFFICERS.
The directors of Merger Sub immediately prior to the Effective
Time shall be the initial directors of the Surviving
Corporation, each to hold office in accordance with the
Certificate of Incorporation and Bylaws of the Surviving
Corporation, and the officers of Merger Sub immediately prior to
the Effective Time shall be the initial officers of the
Surviving Corporation, in each case until their respective
successors are duly elected or appointed and qualified.
1.6. CONVERSION OF MERGER SUB
COMMON STOCK. Each of the shares of the common stock, par
value $.01 per share, of Merger Sub issued and outstanding
immediately prior to the Effective Time shall become shares of
the Surviving Corporation after the Merger and shall thereafter
constitute all of the issued and outstanding shares of the
Surviving Corporation.
1.7. EFFECT ON CAPITAL
STOCK. At the Effective Time, by virtue of the Merger and
pursuant to the terms provided herein, and without any action on
the part of EPIX, Predix or the holders of any of the following
securities except as provided herein:
|
|
|
(a) Conversion of Predix Shares. Every Share
(as defined in Section 1.17) issued and outstanding
immediately prior to the Effective Time (other than the
Dissenting Shares as defined in Section 1.14) shall be
automatically converted into the right to receive
1.248509 shares (the Exchange Ratio) of
validly issued, fully paid and non-assessable EPIX Common Stock
(the Initial Merger Consideration). |
|
|
(b) Cancellation. Each Share held in the
treasury of Predix and each Share owned by EPIX or by any direct
or indirect wholly-owned subsidiary of Predix or EPIX
immediately prior to the Effective Time shall, by virtue of the
Merger and without any action on the part of the holder thereof,
cease to be outstanding, be canceled and retired without payment
of any consideration therefor other than pursuant to the terms
herein and cease to exist. |
|
|
(c) Stock Options. All options to purchase
Predix Common Stock then outstanding under Predixs Amended
and Restated 2003 Stock Incentive Plan (the Predix 2003
Stock Plan) and the |
A-7
|
|
|
Physiome Sciences, Inc. 1997 Stock Option Plan (the
Physiome 1997 Stock Option Plan, together
with the Predix 2003 Stock Plan, the Predix Stock
Plans) shall be assumed by EPIX in accordance with
Section 5.5. |
|
|
(d) Warrants. All warrants outstanding at the
Effective Time to purchase Predix Common Stock or Predix
Preferred Stock (collectively, the Predix
Warrants), shall be assumed by EPIX in accordance with
Section 5.5. |
|
|
(e) Adjustments. If, after the date of this
Agreement, (i) Predix grants additional options to purchase
Predix Common Stock pursuant to Section 4.1(c) or
(ii) EPIX issues additional shares of EPIX Common Stock
before the Effective Time, the Exchange Ratio shall be adjusted
to reflect fully the effect of the issuance of any such options
to purchase Predix Common Stock or additional shares of EPIX
Common Stock, as the case may be. The Exchange Ratio shall be
adjusted to reflect fully the effect of any stock split, reverse
split, stock dividend (including any dividend or distribution of
securities convertible into EPIX Common Stock or Shares),
reorganization, recapitalization or other like change with
respect to EPIX Common Stock or Shares occurring after the date
hereof and prior to the Effective Time. For the avoidance of
doubt, the Exchange Ratio shall equal the quotient of
(i) the sum of (A) the number of outstanding shares of
EPIX Common Stock immediately prior to the Effective Time
divided by .5001 minus (B) the number of outstanding shares
of EPIX Common Stock immediately prior to the Effective Time,
divided by (ii) the number of outstanding Shares and shares
of Predix Common Stock or Predix Preferred Stock reserved for
issuance upon the exercise of outstanding warrants and options,
in each case, as of immediately prior to the Effective Time. |
|
|
(f) Fractional Shares. No fraction of a share
of EPIX Common Stock will be issued, but in lieu thereof each
holder of Predix Common Stock and Predix Preferred Stock who
would otherwise be entitled to a fraction of a share of EPIX
Common Stock (after aggregating all fractional shares of EPIX
Common Stock to be received by such holder) shall receive from
EPIX an amount of cash (rounded to the nearest whole cent),
without interest, equal to the product of (i) such
fraction, multiplied by (ii) the applicable price per share
calculated in accordance with Section 1.7(a) based on the
average closing price of a share of EPIX Common Stock on The
NASDAQ National Market (the NASDAQ) over the
five (5) trading days ending on the trading day prior to
the Effective Time. |
|
|
(g) Limitations. Notwithstanding anything
contained in this Section 1.7, the aggregate number of
shares of EPIX Common Stock issuable under this Section 1.7
(as a result of the conversion of the Shares and the exercise of
the options and warrants, if any, to purchase Predix Common
Stock or Predix Preferred Stock assumed by EPIX) shall in no
event exceed forty-nine and ninety-nine hundredths percent
(49.99%) of the outstanding shares of EPIX Common Stock
immediately after the Effective Time. |
1.8. MILESTONE PAYMENT. In
addition to the shares of EPIX Common Stock to be issued
pursuant to Section 1.7(a) hereof, EPIX shall make a
milestone payment (the Milestone Payment,
together with the Initial Merger Consideration, the
Merger Consideration) as follows:
|
|
|
(a) Amount of Milestone Payment. The
Milestone Payment shall equal $35,000,000. |
|
|
(b) Timing of Milestone Payment. EPIX shall
make the Milestone Payment on a date that is within ninety
(90) days following the Achievement of the Milestone (the
Milestone Payment Date); provided,
that in no case shall the Milestone Payment Date occur before
the Effective Time; and, further provided, that a portion
of the Milestone Payment may be deferred in accordance with
paragraph (d)(ii) below. |
A-8
|
|
|
(c) Achievement of the Milestone. For
purposes of this Agreement, the term Achievement of the
Milestone shall mean EPIXs determination (in
accordance with Section 5.16), whether before or after the
Effective Time, that either of the following occurs on or before
June 30, 2008: |
|
|
|
(i) Clinical Milestone the occurrence of one of
the following: |
|
|
|
(A) Receipt of Positive Data from a randomized, placebo- or
active comparator-controlled, double-blinded Phase II or
Phase III clinical trial of PRX-00023 for the treatment of
Generalized Anxiety Disorder, Depression, ADHD, or other
neuropsychiatric disorder with at least 100 patients. |
|
|
(B) Receipt of Positive Data from a randomized, placebo- or
active comparator-controlled, double-blinded Phase II or
Phase III clinical trial of PRX-03140 for the treatment of
Alzheimers disease or other cognitive disorders with at
least 60 patients. |
|
|
(C) Receipt of Positive Data from a randomized, placebo- or
active comparator-controlled, double-blinded Phase II or
Phase III clinical trial of PRX-08066 for the treatment of
Pulmonary Artery Hypertension, COPD or a different indication as
selected by Predix or after the Effective Time by EPIX with at
least 60 patients. |
|
|
(D) Receipt of Positive Data from a randomized, placebo-or
active comparator-controlled, double-blinded Phase II or
Phase III clinical trial of PRX-07034 for the treatment of
Obesity, Cognitive Disorders or a different indication as
selected by Predix or after the Effective Time by EPIX with at
least 60 patients. |
|
|
|
The term Positive Data shall mean that
PRX-00023, PRX-03140, PRX-08066 or PRX-07034, as the case may
be, shall have demonstrated statistically significant final
results (meaning a p-value of less than 0.05) against the
primary endpoints of the clinical trial in question as set forth
in the applicable protocols of such clinical trial. |
|
|
|
(ii) Predix or the Surviving Corporation, entering into a
strategic partnership for any drug candidate discovered or to be
discovered by Predix that provides for the strategic partner to
make upfront, milestone and research funding payments to Predix
or the Surviving Corporation of greater than $50,000,000,
$20,000,000 of which must be in Unrestricted Cash through
(A) non-refundable license fees, (B) committed and
non-refundable research funding payments; and/or (C) premiums
paid in connection with an equity investment by the strategic
partner upon entering into the strategic partnership or in less
than sixty (60) days following entry into the strategic
partnership. Unrestricted Cash for purposes
of this Section 1.8(c)(ii) shall mean cash payments
received by Predix or the Surviving Corporation by June 30,
2008 that may be used to fund Predixs or the Surviving
Corporations existing or planned research and development
programs as of the Effective Time and reflected in Predixs
2006 operating plan and budget provided to EPIX or the 2007
operating plan and budget approved by the Board of Directors of
EPIX. |
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(d) Form and Value of Payment. The Milestone
Payment shall be paid at the option of EPIX (determined in
accordance with Section 5.16), either: |
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(i) in cash, additional shares of validly issued, fully
paid and non-assessable EPIX Common Stock or any combination
thereof. The number of shares of EPIX Common Stock, if any, to
be issued in connection with this option shall equal
(i) the amount of the Milestone Payment EPIX determines to
pay in shares of EPIX Common Stock, divided by (ii) the
amount that is equal to the average closing price of a share of
EPIX Common Stock on the NASDAQ over the five (5) trading days
ending on the trading day that is ten (10) days prior to
the Milestone Payment Date; or |
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(ii) (x) $20,000,000 payable in accordance with
paragraph (i) above on the Milestone Payment Date and
(y) $15,000,000 (the Deferred Amount)
payable on the date that is twelve (12) months thereafter
(the Deferred Payment Date) in accordance
with Section 1.8(e) below. |
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Notwithstanding the foregoing, the Milestone Payment paid to
each holder of an option or warrant to purchase Predix Common
Stock or Predix Preferred Stock at the Effective Time shall be
made solely in cash and, provided, further that EPIX will
not issue fractional shares of EPIX Common Stock pursuant to
this Section 1.8, but will pay cash in lieu thereof. |
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(e) Deferred Payment. In the event that EPIX
elects to pay the Milestone Payment pursuant to
Section 1.8(d)(ii) above, the Deferred Amount shall be paid
in shares of validly issued, fully paid and non-assessable EPIX
Common Stock to the fullest extent permissible under
Section 1.8(f) below, with any remaining balance paid in
cash plus interest on such cash amount at an annual rate (using
a 360-day year) of ten percent (10%) calculated from the
Milestone Payment Date. The number of shares of EPIX Common
Stock to be issued in connection with this Section 1.8(e)
shall equal (i) the Deferred Amount, divided by
(ii) seventy-five percent (75%) of the amount that is equal
to the average closing price of a share of EPIX Common Stock on
the NASDAQ over the thirty (30) trading days ending on the
trading day that is ten (10) days prior to the Deferred
Payment Date. |
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(f) Limitations. Notwithstanding anything
else contained herein, in no event shall the aggregate number of
shares of EPIX Common Stock that may be issued pursuant to this
Section 1.8, when combined with the aggregate Initial
Merger Consideration and shares of EPIX Common Stock issued or
issuable as a result of the exercise of the options and
warrants, if any, to purchase Predix Common Stock or Predix
Preferred Stock assumed by EPIX, exceed forty-nine and
ninety-nine hundredths percent (49.99%) of the outstanding
shares of EPIX Common Stock immediately after such issuance. |
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(g) Allocation of Milestone Payment. The
Milestone Payment shall be allocated and paid to each holder of
record at the Effective Time of a Share, Predix Warrant or an
option to purchase Predix Common Stock, in each case, pro rata
based upon the percentage of the Initial Merger Consideration
that such holder would have received pursuant to
Section 1.7(a), assuming that for these purposes that each
Predix Warrant and option to purchase Predix Common Stock or
Predix Preferred Stock (whether or not vested) was exercised in
full immediately prior to the Effective Time. |
1.9. EXCHANGE OF
CERTIFICATES.
(a) Exchange Agent. EPIX shall make available
or cause to be made available, to or for the account of a bank
or trust company designated by EPIX (the Exchange
Agent), in trust for the benefit of the holders of
Predix Common Stock and Predix Preferred Stock, for exchange in
accordance with Section 1.7 and this Section 1.9,
through the Exchange Agent, (i) certificates evidencing the
EPIX Common Stock issuable pursuant to this Agreement in
exchange for outstanding Shares, and (ii) an amount of cash
sufficient to permit the Exchange Agent to make necessary
payments of cash in lieu of fractional shares of EPIX Common
Stock in accordance with Section 1.7(f).
(b) Exchange Procedures. As soon as
reasonably practicable after the Effective Time, EPIX will
instruct the Exchange Agent to mail to each holder of record of
a certificate or certificates which immediately prior to the
Effective Time evidenced outstanding Shares (the
Certificates) (i) a letter of
transmittal (which shall specify that delivery shall be
effected, and risk of loss and title to the Certificates shall
pass, only upon proper delivery of the Certificates to the
Exchange Agent and shall be in such form and have such other
provisions as EPIX may reasonably specify after review by
Predix) and (ii) instructions to effect the surrender of
the Certificates in exchange for the certificates evidencing
shares of EPIX Common Stock and, in lieu of any fractional
shares thereof, cash. Upon surrender of a Certificate for
cancellation to the Exchange Agent together with such letter of
transmittal, duly executed, and such other customary documents
as may be required pursuant to such instructions, the holder of
such Certificate shall be entitled to receive in exchange
therefore: (A) certificates evidencing that number of whole
shares of EPIX Common Stock which such holder has the right to
receive in accordance with the Exchange Ratio, in respect of the
Shares formerly evidenced by such Certificate, (B) the
Milestone Payment, (C) any dividends or other distributions
to which such holder is entitled pursuant to
Section 1.7(e), and (D) cash in lieu of fractional
shares of EPIX Common Stock to which such holder is
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entitled pursuant to Section 1.7(f), and the Certificate so
surrendered shall forthwith be canceled. In the event of a
transfer of ownership of Shares which are not registered in the
transfer records of Predix as of the Effective Time, EPIX Common
Stock and cash may be issued and paid in accordance with this
Article I to a transferee if the Certificate evidencing
such Shares are presented to the Exchange Agent, accompanied by
all documents required to evidence and effect such transfer
pursuant to this Section 1.9(b) and by evidence that any
applicable stock transfer taxes have been paid. Until so
surrendered, each outstanding Certificate that, prior to the
Effective Time, represented Shares will be deemed from and after
the Effective Time, for all corporate purposes, other than the
payment of dividends, if any, to evidence the right to receive
the number of full shares of EPIX Common Stock into which such
Shares shall have been so converted, the right to receive the
Milestone Payment and the right to receive an amount in cash in
lieu of the issuance of any fractional shares in accordance with
Section 1.7.
(c) Distributions with Respect to Unexchanged
Shares. No dividends or other distributions declared or
made after the Effective Time, with respect to EPIX Common Stock
with a record date after the Effective Time, shall be paid to
the holder of any unsurrendered Certificate until the holder of
such Certificate shall surrender such Certificate. Subject to
applicable law, following surrender of any such Certificate,
there shall be paid to the record holder of the certificates
representing whole shares of EPIX Common Stock issued in
exchange therefor, without interest, at the time of such
surrender, the amount of dividends or other distributions with a
record date after the Effective Time theretofore paid with
respect to such whole shares of EPIX Common Stock.
(d) Transfers of Ownership. If any
certificate for shares of EPIX Common Stock is to be issued in a
name other than that in which the Certificate surrendered in
exchange therefor is registered, it will be a condition of the
issuance thereof that the Certificate so surrendered will be
properly endorsed and otherwise in proper form for transfer and
that the person requesting such exchange will have paid to EPIX
or any person designated by it any transfer or other taxes
required by reason of the issuance of a certificate for shares
of EPIX Common Stock in any name other than that of the
registered holder of the certificate surrendered, or established
to the satisfaction of EPIX or any agent designated by it that
such tax has been paid or is not payable.
(e) No Liability. Notwithstanding anything to
the contrary in this Section 1.9, neither EPIX nor Predix
shall be liable to any holder of Predix Common Stock, Predix
Preferred Stock, options or warrants to purchase Predix Common
Stock or Predix Preferred Stock at the Effective Time or EPIX
Common Stock for any Merger Consideration (or dividends or
distributions with respect thereto) delivered to a public
official pursuant to any applicable abandoned property, escheat
or similar law.
(f) Withholding Rights. EPIX, the Surviving
Corporation and the Exchange Agent shall be entitled to deduct
and withhold from the Merger Consideration otherwise payable
pursuant to this Agreement to any holder of Shares, such amounts
as EPIX, the Surviving Corporation or the Exchange Agent is
required to deduct and withhold with respect to the making of
such payment under the Code or any provision of state, local,
provincial or foreign tax law. To the extent that amounts are so
withheld, such withheld amounts shall be treated for all
purposes of this Agreement as having been paid to the holder of
the Shares in respect of which such deduction and withholding
was made by EPIX, the Surviving Corporation or the Exchange
Agent.
(g) Return of Merger Consideration to Surviving
Corporation. Any portion of the Initial Merger
Consideration that remains undistributed to the holders of
Predix Common Stock or Predix Preferred Stock six
(6) months after the Effective Time and any portion of the
Milestone Payment that remains undistributed to the holders of
EPIX Common Stock or options or warrants to purchase Predix
Common Stock or Predix Preferred Stock assumed by EPIX pursuant
to this Agreement six (6) months after the payment of the
Milestone Payment (or termination of the Achievement of the
Milestone), shall be delivered to the Surviving Corporation,
upon demand, and any such holders of Predix Common Stock, Predix
Preferred Stock, EPIX Common Stock and options or warrants to
purchase Predix Common Stock or Predix Preferred Stock assumed
by EPIX pursuant to this Agreement who have not theretofore
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complied with the provisions of this Article I shall
thereafter look only to the Surviving Corporation for the Merger
Consideration to which they are entitled hereunder.
1.10. STOCK TRANSFER BOOKS.
At the Effective Time, the stock transfer books of Merger Sub
and Predix shall be closed, and there shall be no further
registration of transfers of Merger Sub common stock or Predix
Common Stock or Predix Preferred Stock thereafter on the records
of Merger Sub or Predix, respectively.
1.11. NO FURTHER OWNERSHIP
RIGHTS IN PREDIX COMMON STOCK AND PREDIX PREFERRED STOCK.
The portion of the Merger Consideration delivered upon the
surrender for exchange of Shares in accordance with the terms
hereof shall be deemed to have been issued in full satisfaction
of all rights pertaining to such Shares, and there shall be no
further registration of transfers on the records of the
Surviving Corporation of Shares which were outstanding
immediately prior to the Effective Time. If, after the Effective
Time, Certificates are presented to the Surviving Corporation
for any reason, they shall be canceled and exchanged as provided
in this Article I.
1.12. LOST, STOLEN OR DESTROYED
CERTIFICATES. In the event any Certificates shall have been
lost, stolen or destroyed, the Exchange Agent shall issue in
exchange for such lost, stolen or destroyed Certificates, upon
the making of an affidavit of that fact by the holder thereof,
such shares of EPIX Common Stock as may be required pursuant to
Section 1.7; provided, however, that EPIX
may, in its sole discretion and as a condition precedent to the
issuance thereof, require the owner of such lost, stolen or
destroyed Certificates to deliver a bond in such sum as it may
reasonably direct as indemnity against any claim that may be
made against EPIX, the Surviving Corporation or the Exchange
Agent with respect to the Certificates alleged to have been
lost, stolen or destroyed.
1.13. TAX CONSEQUENCES. It
is intended by the parties hereto that the Merger shall
constitute a reorganization within the meaning of
Section 368 of the Code. The parties hereto hereby adopt
this Agreement as a plan of reorganization within
the meaning of Sections 1.368-2(g) and 1.368-3(a) of the
United States Treasury Regulations.
1.14. APPRAISAL RIGHTS.
Notwithstanding anything in this Agreement to the contrary,
Shares issued and outstanding immediately prior to the Effective
Time and held by a Predix stockholder who has not voted in favor
of the Merger, consented thereto in writing or otherwise
contractually waived their rights to appraisal and who has
complied with all of the relevant provisions of Section 262
of the Delaware Law, (a Dissenting
Shareholder) shall not be converted into the right to
receive the Merger Consideration provided in Section 1.9(b)
hereof unless and until such holder fails to perfect or
effectively withdraws or otherwise loses such holders
right to appraisal under Delaware Law. A Dissenting Shareholder
may receive payment of the fair value of the Shares issued and
outstanding immediately prior to the Effective Time and held by
such Dissenting Shareholder (Dissenting
Shares) in accordance with the provisions of Delaware
Law, provided, that such Dissenting Shareholder complies
with Section 262 of Delaware Law. At the Effective Time,
all Dissenting Shares shall be cancelled and cease to exist and
shall represent only the right to receive the fair value thereof
in accordance with Delaware Law. If, after the Effective Time,
any Dissenting Shareholder fails to perfect or effectively
withdraws or otherwise loses such Dissenting Shareholders
right to appraisal, such Dissenting Shareholders
Dissenting Shares shall thereupon be treated as if they had been
converted, as of the Effective Time, into the right to receive
the Merger Consideration set forth in Section 1.9(b)
hereof. Predix shall give EPIX (a) prompt notice of any
written demands for appraisal, withdrawals of demands for
appraisal and any other instruments served under Delaware Law
and (b) the opportunity to participate in and direct all
negotiations, proceedings or settlements with respect to demands
for appraisal under Delaware Law. Predix shall not voluntarily
make any payment with respect to any demands for appraisal and
shall not, except with EPIXs prior written consent, settle
or offer to settle any such demands.
1.15. TAKING OF NECESSARY
ACTION; FURTHER ACTION. Each of EPIX, Merger Sub and Predix
in good faith will take all such commercially reasonable and
lawful action as may be necessary or appropriate in order to
effectuate the Merger in accordance with this Agreement as
promptly as possible. If, at any time after the Effective Time,
any such further action is necessary or desirable to carry out
the
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purposes of this Agreement and to vest the Surviving Corporation
with full right, title and possession to all assets, property,
rights, privileges, powers and franchises of Predix, the
officers and directors of Merger Sub and Predix are fully
authorized in the name of the corporation or otherwise to take,
and will take, all such lawful and necessary action.
1.16. MATERIAL ADVERSE
EFFECT. When used in this Agreement with respect to EPIX or
Predix as the case may be, the term Material Adverse
Effect means any change or effect that, individually
or when taken together with all other such changes or effects
that have occurred prior to the date of determination of the
occurrence of the Material Adverse Effect, is or is reasonably
likely to be materially adverse to the business, assets
(including intangible assets), condition (financial or
otherwise) or results of operations of EPIX or Predix and/or its
subsidiaries, as the case may be.
1.17. SHARES. When used in
this Agreement, the term Shares shall mean the
Predix Common Stock and Predix Preferred Stock on the following
basis: (i) with respect to the Predix Common Stock, one
Share shall represent one share of Predix Common Stock and
(ii) with respect to the Predix Preferred Stock, one Share
shall represent 18 shares of Predix Preferred Stock.
ARTICLE II
REPRESENTATIONS AND WARRANTIES OF PREDIX
Predix hereby represents and warrants to EPIX and Merger Sub as
follows, except as set forth in the written disclosure schedule
delivered by Predix to EPIX (the Predix Disclosure
Schedule). The Predix Disclosure Schedule shall be
arranged in sections and subsections corresponding to the
numbered and lettered sections and subsections contained in this
Article II. The inclusion of any information in the Predix
Disclosure Schedule (or any update thereto) shall not be deemed
to be an admission or acknowledgment, in and of itself, that
such information is required by the terms hereof to be
disclosed, is material, has resulted in or would result in a
Material Adverse Effect, or is outside the ordinary course of
business. For purposes of this Agreement, the phrase to
the knowledge of Predix or its subsidiaries or
any phrase of similar import shall mean and be limited to the
actual knowledge of the individuals set forth on
Schedule 1 hereto.
2.1. ORGANIZATION OF PREDIX.
Predix and each of its subsidiaries is a corporation duly
organized, validly existing and in good standing under the laws
of the jurisdiction of its incorporation, has all requisite
corporate power and authority to own, lease and operate its
property and to carry on its business as now being conducted and
as proposed to be conducted, and is duly qualified to do
business and in good standing as a foreign corporation in each
jurisdiction in which the failure to be so qualified would have
a Material Adverse Effect on Predix. Predix has delivered or
made available a true and correct copy of its and its
subsidiaries Certificates of Incorporation and Bylaws,
each as amended to date, to EPIX. Section 2.1 of the Predix
Disclosure Schedule lists each subsidiary of Predix, including
its jurisdiction of incorporation.
2.2. CAPITAL STRUCTURE. As
of the date hereof, the authorized capital stock of Predix
consists of 338,085,813 shares of Common Stock, par value
$.01 per share (the Predix Common
Stock), of which 1,044,059 shares are issued and
outstanding and 275,298,740 shares of Preferred Stock, par
value $.01 per share, of which 76,771,672 shares are
designated Series AB Convertible Preferred Stock, par value
$.01 per share (the Series AB Preferred
Stock), of which 76,771,672 are issued and outstanding
and such shares are convertible on an eighteen (18) shares
for one (1) share basis into 4,265,060 shares of
Predix Common Stock and 198,527,068 shares are designated
Series C Convertible Preferred Stock, par value
$.01 per share (the Series C Preferred
Stock, together with the Series AB Preferred
Stock, the Predix Preferred Stock), of which
196,431,820 are issued and outstanding and such shares are
convertible on an eighteen (18) shares for one
(1) share basis into 10,912,838 shares of Predix
Common Stock. No shares of capital stock are held in
Predixs treasury. All outstanding shares of Predix Common
Stock and Predix Preferred Stock are duly authorized, validly
issued, fully paid and non-assessable and are not subject to
preemptive rights created by statute, the Certificate of
Incorporation or Bylaws of Predix or
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any agreement or document to which Predix or any of its
subsidiaries is a party or by which it or any of its
subsidiaries is bound, and were issued in compliance with all
applicable federal and state securities laws. As of the date
hereof, Predix has reserved an aggregate of
3,648,905 shares of Predix Common Stock, net of exercises,
for issuance to employees, consultants and non-employee
directors pursuant to the Predix 2003 Stock Plan under which
options are outstanding for an aggregate of
2,202,498 shares, an aggregate of 4,482 shares of
Predix Common Stock, net of exercises, for issuance to
employees, consultants and non-employee directors pursuant to
the Physiome 1997 Stock Option Plan under which options are
outstanding for an aggregate of 4,482 shares and
213,687 shares of Predix Common Stock are reserved for
issuance to holders of Predix Warrants upon their exercise. All
shares of Predix Common Stock subject to issuance as aforesaid,
upon issuance on the terms and conditions specified in the
instruments pursuant to which they are issuable, would be duly
authorized, validly issued, fully paid and non-assessable.
Section 2.2 of the Predix Disclosure Schedule lists each
holder of Predix Common Stock and Predix Preferred Stock, each
outstanding option and warrant to acquire shares of Predix
Common Stock or Predix Preferred Stock, as applicable, the name
of the holder of such option or warrant, the number of shares
subject to such option or warrant, the exercise price of such
option or warrant, the number of shares as to which such option
or warrant will have vested at such date, the vesting schedule
and termination date of such option or warrant and whether the
exercisability of such option or warrant will be accelerated in
any way by the transactions contemplated by this Agreement or
for any other reason, indicating the extent of acceleration, if
any.
2.3. OBLIGATIONS WITH RESPECT TO
CAPITAL STOCK. Except as set forth in Section 2.2 of
the Predix Disclosure Schedule and except for the convertibility
of the Predix Preferred Stock into Predix Common Stock, there
are no equity securities of any class of Predix, or any
securities exchangeable or convertible into or exercisable for
such equity securities, authorized, issued, reserved for
issuance or outstanding. Except for securities Predix or its
subsidiaries owns, directly or indirectly through one or more
subsidiaries, there are no equity securities of any class of any
subsidiary of Predix or its subsidiaries or any security
exchangeable or convertible into or exercisable for such equity
securities, issued, reserved for issuance or outstanding. Except
as set forth in Section 2.2 of the Predix Disclosure
Schedule, there are no options, warrants, equity securities,
calls, rights (including preemptive rights), commitments or
agreements of any character to which Predix or any of its
subsidiaries is a party or by which it or any of its
subsidiaries is bound obligating Predix or its subsidiaries to
issue, deliver or sell, or cause to be issued, delivered or
sold, or to repurchase, redeem or otherwise acquire, or cause
the repurchase, redemption or acquisition of, any shares of
capital stock of Predix or its subsidiaries or obligating Predix
or its subsidiaries to grant, extend, accelerate the vesting of
or enter into any such option, warrant, equity security, call,
right, commitment or agreement. Except as set forth in
Section 2.2 of the Predix Disclosure Schedule, there are no
registration rights and, to the knowledge of Predix and its
subsidiaries, there are no voting trusts, proxies or other
agreements or understandings with respect to any equity security
of any class of Predix or its subsidiaries.
2.4. AUTHORITY.
(a) Predix has all requisite corporate power and authority
to enter into this Agreement and to consummate the transactions
contemplated hereby. The execution and delivery of this
Agreement and the consummation of the transactions contemplated
hereby have been duly authorized by all necessary corporate
action on the part of Predix, subject only to the approval of
the Merger by Predixs stockholders as contemplated in
Section 5.2 and to the filing and recordation of the
Certificate of Merger pursuant to Delaware Law. This Agreement
has been duly executed and delivered by Predix and, assuming the
due authorization, execution and delivery of this Agreement by
the other parties hereto, this Agreement constitutes the valid
and binding obligation of Predix, enforceable in accordance with
its terms, except as enforceability may be limited by bankruptcy
and other similar laws and general principles of equity. Except
as set forth in Section 2.4(a) of the Predix Disclosure
Schedule, the execution and delivery of this Agreement does not,
and the performance of this Agreement will not,
(i) conflict with or violate the Certificate of
Incorporation or Bylaws of Predix, (ii) subject to
obtaining the approval of the Merger by Predixs
stockholders as contemplated in Section 5.2 and compliance
with the requirements set forth in Section 2.4(b) below,
conflict with or violate any law, rule, regulation, order,
judgment or decree
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applicable to Predix or its subsidiaries or by which its or its
subsidiaries properties are bound or affected, or
(iii) except as would not reasonably be expected to have a
Material Adverse Effect and subject to obtaining the consents
set forth in Section 2.4(a) of the Predix Disclosure
Schedule, result in any breach of or constitute a default (or an
event that with notice or lapse of time or both would become a
default) under, or impair Predixs or its
subsidiaries rights or alter the rights of obligations of
any third party under, or give to others any rights of
termination, amendment, acceleration or cancellation of, or
result in the creation of a lien or encumbrance on any of the
properties or assets of Predix or its subsidiaries pursuant to,
any note, bond, mortgage, indenture, contract, agreement, lease,
license, permit, franchise or other instrument or obligation to
which Predix or any of its subsidiaries is a party or by which
Predix or its subsidiaries or its or its subsidiaries
properties are bound or affected, except, with respect to
clauses (ii) and (iii), for any such conflicts, violations,
defaults or other occurrences that would not have a Material
Adverse Effect on Predix. Section 2.4 of the Predix
Disclosure Schedule lists all material consents, waivers and
approvals under any of Predixs or its subsidiaries
agreements, contracts, licenses or leases required to be
obtained in connection with the consummation of the transactions
contemplated hereby.
(b) No consent, approval, license, permit, registration,
waiver, qualification, order or authorization, or registration,
declaration or filing, with or of, as appropriate
(Approval) of (i) any person or
(ii) any Governmental Authority (as defined in
Section 6.1(b) hereof) is required by or with respect to
Predix or its subsidiaries in connection with the execution and
delivery of this Agreement or any related agreements required to
be executed by this Agreement or the consummation of the
transactions contemplated hereby and thereby, except for
(i) the filing of a
Form S-4
Registration Statement (the Registration
Statement) with the Securities and Exchange Commission
(SEC) in accordance with the Securities Act
of 1933, as amended (the Securities Act),
(ii) the filing of the Certificate of Merger with the
Secretary of State of the State of Delaware, (iii) such
Approvals as may be required under applicable federal and state
securities laws and the laws of any foreign country including,
without limitation, the HSR Act (as defined below), and
(iv) such other Approvals which, if not obtained or made,
would not have a Material Adverse Effect on Predix or would not
have a material adverse effect on the ability of the parties
hereto to consummate the Merger.
2.5. PREDIX FINANCIAL
STATEMENTS.
(a) The audited consolidated financial statements
(including any related notes thereto) representing the financial
condition of Predix and its subsidiaries as of December 31,
2005 (collectively, the Predix Financials)
(x) complied, or will comply as to form in all material
respects prior to the filing of the Registration Statement, with
the published rules and regulations of the SEC with respect
thereto, (y) were prepared in accordance with United States
generally accepted accounting principles
(GAAP) applied on a consistent basis
throughout the periods involved (except as may be indicated in
the notes thereto, and (z) fairly presented the financial
position of Predix as at the respective dates thereof and the
consolidated results of its operations and cash flows for the
periods indicated. The balance sheet of Predix as of
December 31, 2005 is hereinafter referred to as the
Predix Balance Sheet. Except as disclosed in
the Predix Financials, Predix and its subsidiaries have no
liabilities (absolute, accrued, contingent or otherwise) of a
nature required to be disclosed on a balance sheet or in the
related notes to consolidated financial statements prepared in
accordance with GAAP which are, individually or in the
aggregate, material to the business, results of operations or
financial condition of Predix and its subsidiaries, except
liabilities (i) provided for in the Predix Balance Sheet,
or (ii) incurred since the date of the Predix Balance Sheet
in the ordinary course of business consistent with either past
practices in both type and amount.
(b) Predix maintains adequate disclosure controls and
procedures designed to ensure that material information relating
to Predix, including its subsidiaries, is made known to the
Chief Executive Officer and the Chief Financial Officer of
Predix by others within those entities. To Predixs
knowledge, there are no (i) significant deficiencies and
material weaknesses in the design or operation of internal
controls over financial reporting which are reasonably likely to
adversely affect in any material respect Predixs ability
to record, process, summarize and report financial information
and (ii) fraud, or allegation of fraud, whether
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or not material, that involves management or other employees who
have a significant role in Predixs internal controls over
financial reporting.
(c) Predix maintains a system of internal accounting
controls designed to provide reasonable assurance that:
(i) transactions are executed in accordance with
managements general or specific authorizations;
(ii) transactions are recorded as necessary to permit
preparation of financial statements in conformity with GAAP
principles and to maintain asset accountability;
(iii) access to assets is permitted only in accordance with
managements general or specific authorization; and
(iv) the recorded accountability for assets is compared
with the existing assets at reasonable intervals and appropriate
action is taken with respect to any differences.
2.6. ABSENCE OF CERTAIN CHANGES
OR EVENTS. Since the date of the Predix Balance Sheet
through the date of this Agreement, Predix and its subsidiaries
have conducted their business only in the ordinary course of
business consistent with past practice, and there has not been:
(i) any event that has had, or that would be reasonably
expected to result in, a Material Adverse Effect on Predix,
(ii) any material change by Predix or any of its
subsidiaries in its accounting methods, principles or practices,
except as required by concurrent changes in GAAP, (iii) any
revaluation or disposition by Predix or its subsidiaries of any
of its assets having a Material Adverse Effect on Predix or
(iv) any other action, event or occurrence that would have
required the consent of EPIX pursuant to Section 4.1 of
this Agreement had such action, event or occurrence taken place
after the execution and delivery of this Agreement.
2.7. TAXES. Predix and its
subsidiaries have accurately prepared and timely filed or had
prepared and timely filed on their behalf, all returns,
declarations, reports, statements, information statements and
other documents filed or required to be filed (Predix
Tax Returns) with respect to any and all federal,
state, local and foreign taxes, assessments and other
governmental charges, duties, impositions and liabilities,
including, without limitation, taxes based upon or measured by
gross receipts, income, profits, sales, use and occupation,
value added, ad valorem, transfer, franchise, withholding,
payroll, recapture, employment, excise and property taxes,
together with all interest, penalties and additions imposed with
respect to such amounts and any obligations under any agreements
or arrangements with any other person with respect to such
amounts and including any liability for taxes of a predecessor
entity concerning or attributable to Predix or its subsidiaries
or to their operations (Predix Taxes), and
all such Predix Tax Returns are true, complete and correct in
all material respects. Copies of all such returns filed after
January 1, 2003 have been delivered to EPIX.
In addition:
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(a) Predix and its subsidiaries: (i) have paid all
Taxes they are obligated to pay as reflected on the Tax Returns
or otherwise; and (ii) have withheld all federal, state,
local and foreign Taxes required to be withheld with respect to
their employees or otherwise. |
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(b) There is no Tax deficiency outstanding, proposed or
assessed against Predix and its subsidiaries that is not
accurately reflected as a liability on the Predix Balance Sheet,
nor have Predix or its subsidiaries executed any waiver of any
statute of limitations on or extending the period for the
assessment or collection of any Tax. |
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(c) Predix and its subsidiaries do not have any liability
for unpaid Taxes that has not been properly accrued for under
GAAP and reserved for on the Predix Balance Sheet, whether
asserted or unasserted, contingent or otherwise. |
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(d) Predix and its subsidiaries are not a party to any
agreement, plan, arrangement or other contract covering any
employee or independent contractor or former employee or
independent contractor that, individually or collectively with
any other such contracts, would reasonably be expected to give
rise directly or indirectly to the payment of any amount that
would not be deductible pursuant to Section 280G or
Section 162(m) of the Code (or any comparable provision of
state or foreign tax laws). |
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(e) Predix and its subsidiaries are not, nor have ever
been, a party to or bound by any tax indemnity agreement, tax
sharing agreement, tax allocation agreement or similar contract
or agreement. |
2.8. INTELLECTUAL PROPERTY.
(a) Predix owns, or has the right to use, sell or license,
and has the right to bring actions for the infringement of, all
intellectual property utilized in its business as presently
conducted or that of its subsidiaries, which intellectual
property is listed on Section 2.8(a) of the Predix
Disclosure Schedule (such intellectual property and the rights
thereto are collectively referred to herein as the
Predix IP Rights), except for any failure to
own or have the right to use, sell or license that would not
reasonably be expected to have a Material Adverse Effect on
Predix.
(b) The execution, delivery and performance of this
Agreement and the consummation of the transactions contemplated
hereby will not constitute a breach of any instrument or
agreement governing any Predix IP Rights (the Predix IP
Rights Agreements), will not cause the forfeiture or
termination or give rise to a right of forfeiture or termination
of any Predix IP Rights or impair the right of Predix, its
subsidiaries or the Surviving Corporation to use, sell or
license any Predix IP Rights or portion thereof, except for the
occurrence of any such breach, forfeiture, termination or
impairment that would not individually or in the aggregate,
reasonably be expected to result in a Material Adverse Effect on
Predix. Each of the Predix IP Rights Agreements is valid and
binding on Predix or its subsidiaries and in full force and
effect; (ii) Predix and its subsidiaries have not received
any notice of termination or cancellation under such agreement,
or received any notice of breach or default under such
agreement, which breach has not been cured or waived; and
(iii) Predix and its subsidiaries, and to the knowledge of
Predix and its subsidiaries, any other party to such agreement,
is not in breach or default thereof in any material respect.
(c) (i) Neither the manufacture, marketing, license,
sale or intended use of any product or technology currently
licensed or sold or under development by Predix or its
subsidiaries violates any license or agreement between Predix or
its subsidiaries and any third party or, to the knowledge of
Predix and its subsidiaries, infringes any intellectual property
right of any other party; (ii) to the knowledge of Predix
and its subsidiaries, no third party is infringing upon, or
violating any license or agreement with Predix or its
subsidiaries relating to any Predix IP Rights; and (iii) to
the knowledge of Predix and its subsidiaries, there is no
pending or threatened claim or litigation contesting the
validity, ownership or right to use, sell, license or dispose of
any Predix IP Rights, nor has Predix or any of its subsidiaries
received any written notice asserting that any Predix IP Rights
or the proposed use, sale, license or disposition thereof
conflicts or will conflict with the rights of any other party.
(d) Predix and its subsidiaries have used reasonable
efforts to maintain their material trade secrets in confidence,
including entering into licenses and contracts that generally
require licensees, contractors and other third persons with
access to such trade secrets to keep such trade secrets
confidential and have otherwise taken reasonable and practicable
steps designed to safeguard and maintain the secrecy and
confidentiality of, and its proprietary rights in, all Predix IP
Rights.
2.9. COMPLIANCE; PERMITS;
RESTRICTIONS.
(a) Predix and its subsidiaries are not in conflict with,
or in default or violation of (i) any law, rule,
regulation, order, judgment or decree applicable to them or by
which their properties are bound or affected, or (ii) any
note, bond, mortgage, indenture, contract, agreement, lease,
license, permit, franchise or other instrument or obligation to
which Predix or any of its subsidiaries is a party or by which
Predix or any of its subsidiaries or their properties are bound
or affected, except for any conflicts, defaults or violations
which would not reasonably be expected to have a Material
Adverse Effect on Predix. No investigation or review by any
governmental or regulatory body or authority is pending or, to
the knowledge of Predix and its subsidiaries, threatened against
Predix or its subsidiaries, nor has any governmental or
regulatory body or authority indicated to Predix or its
subsidiaries an intention to conduct the same.
(b) Predix and its subsidiaries hold all permits, licenses,
variances, exemptions, orders and approvals from governmental
authorities which are material to the operation of the business
of Predix and its
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subsidiaries (collectively, the Predix
Permits). Predix and its subsidiaries are in
compliance with the terms of the Predix Permits, except where
the failure to so comply would not reasonably be expected to
have a Material Adverse Effect on Predix. No action, proceeding,
revocation proceeding, amendment procedure, writ, injunction or
claim is pending or, to the knowledge of Predix and its
subsidiaries, threatened, which seeks to revoke or limit any
Predix Permit. A true, complete and correct list of the material
Predix Permits is set forth in Section 2.9(b) of the Predix
Disclosure Schedule. The rights and benefits of each material
Predix Permit will be available to the Surviving Corporation or
its subsidiaries immediately after the Effective Time on terms
substantially identical to those enjoyed by Predix and its
subsidiaries immediately prior to the Effective Time.
(c) All biological and drug products being manufactured,
distributed, developed or tested by or on behalf of Predix or
its subsidiaries (Predix Pharmaceutical
Products) that are subject to the jurisdiction of the
Food and Drug Administration (FDA) are being
manufactured, labeled, stored, tested, distributed, and marketed
in compliance in all material respects with all applicable
requirements under the Federal Food, Drug, and Cosmetic Act
(FDCA), the Public Health Service Act, their
applicable implementing regulations, and all comparable state
laws and regulations.
(d) All clinical trials conducted by or on behalf of Predix
or its subsidiaries are being conducted in material compliance
with the applicable requirements of Good Clinical Practice,
Informed Consent, and all applicable requirements relating to
protection of human subjects contained in 21 CFR Parts 50,
54, and 56.
(e) All manufacturing operations for Predix Pharmaceutical
Products conducted by or for the benefit of Predix or its
subsidiaries are being conducted in accordance, in all material
respects, with the FDAs current Good Manufacturing
Practices for drug and biological products. In addition, Predix
and its subsidiaries are in material compliance with all
applicable registration and listing requirements set forth in
21 U.S.C. Section 360 and 21 CFR Part 207
and all similar applicable laws and regulations.
(f) Neither Predix or its subsidiaries, nor any
representative of Predix or its subsidiaries, nor, to the
knowledge of Predix or its subsidiaries, any of Predixs or
its subsidiaries licensees or assignees of Predix IP
Rights has received any notice that the FDA or any other
Governmental Authority has initiated, or threatened to initiate,
any action to suspend any clinical trial, suspend or terminate
any Investigational New Drug Application sponsored by Predix or
its subsidiaries or otherwise restrict the preclinical research
on or clinical study of any Predix Pharmaceutical Product or any
biological or drug product being developed by any licensee or
assignee of Predix IP Rights based on such intellectual
property, or to recall, suspend or otherwise restrict the
development or manufacture of any Predix Pharmaceutical Product.
(g) Neither Predix or its subsidiaries nor, to the
knowledge of Predix or its subsidiaries, any of their officers,
employees, agents or clinical investigators acting for Predix or
its subsidiaries, has committed any act, made any statement or
failed to make any statement that would reasonably be expected
to provide a basis for the FDA to invoke its policy with respect
to Fraud, Untrue Statements of Material Facts, Bribery,
and Illegal Gratuities set forth in 56 Fed. Reg. 46191
(September 10, 1991) and any amendments thereof.
Additionally, neither Predix or its subsidiaries, nor to the
knowledge of Predix or its subsidiaries, any officer, key
employee or agent of Predix or its subsidiaries has been
convicted of any crime or engaged in any conduct that would
reasonably be expected to result in (i) debarment under
21 U.S.C. Section 335a or any similar state law or
(ii) exclusion under 42 U.S.C.
Section 1320a-7 or
any similar state law or regulation.
(h) All animal studies or other preclinical tests performed
as the basis for any regulatory approval required for the Predix
Pharmaceutical Products (1) either (x) have been
conducted in accordance, in all material respects, with
applicable Good Laboratory Practice requirements contained in
21 CFR Part 58, or (y) were not required to be
conducted in accordance with Good Laboratory Practice
requirements contained in 21 CFR Part 58 and
(2) have employed the procedures and controls generally
used by qualified experts in animal or preclinical study of
products comparable to those being developed by Predix or its
subsidiaries.
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(i) Predix and its subsidiaries have made available to EPIX
copies of any and all written notices of inspectional
observations, establishment inspection reports and any other
documents received from the FDA, that indicate or suggest lack
of compliance with the regulatory requirements of the FDA.
Predix and its subsidiaries have made available to EPIX for
review all correspondence to or from the FDA, minutes of
meetings, written reports of phone conversations, visits or
other contact with the FDA, notices of inspectional
observations, establishment inspection reports, and all other
documents concerning communications to or from the FDA, or
prepared by the FDA or which bear in any way on Predixs
and its subsidiaries compliance with regulatory
requirements of the FDA, or on the likelihood of timing of
approval of any Predix Pharmaceutical Products.
(j) There are no proceedings pending with respect to a
violation by Predix or its subsidiaries of the FDCA, FDA
regulations adopted thereunder, the Controlled Substance Act or
any other legislation or regulation promulgated by any other
United States Governmental Authority.
2.10. LITIGATION. As of the
date of this Agreement, there is no action, suit, proceeding,
claim, arbitration or investigation pending, or as to which
Predix or its subsidiaries have received any written notice of
assertion, nor, to the knowledge of Predix or its subsidiaries,
is there any threatened action, suit, proceeding, claim for
arbitration or investigation against Predix or its subsidiaries,
which, if adversely determined, would have a Material Adverse
Effect on Predix.
2.11. BROKERS AND
FINDERS FEES. Other then Lehman Brothers Inc., Predix
and its subsidiaries have not incurred, nor will they incur,
directly or indirectly, any liability for brokerage or
finders fees or agents commissions or any similar
charges in connection with this Agreement or any transaction
contemplated hereby.
2.12. EMPLOYEE BENEFIT PLANS.
(a) Section 2.12(a) of the Predix Disclosure Schedule
lists all written and describes all non-written employee benefit
plans (as defined in Section 3(3) of the Employee
Retirement Income Security Act of 1974, as amended
(ERISA)) and all bonus, stock or other
security option, stock or other security purchase, stock or
other security appreciation rights, incentive, deferred
compensation, retirement or supplemental retirement, profit
sharing, severance, golden parachute, vacation, cafeteria,
dependent care, medical care, employee assistance program,
education or tuition assistance programs, insurance and other
similar fringe or employee benefit plans, programs or
arrangements, and any current or former employment or executive
compensation or severance agreements, written or otherwise,
which are currently sponsored, maintained, contributed to or
entered into for the benefit of, or relating to, any present or
former employee or director of Predix, or any trade or business
(whether or not incorporated) which is a member of a controlled
group or which is under common control with Predix within the
meaning of Section 414 of the Code (an ERISA
Affiliate), whether or not such plan is terminated
(collectively, the Predix Employee Plans).
(b) With respect to each Predix Employee Plan, Predix has
provided to EPIX a true and complete copy of, to the extent
applicable, (i) such Predix Employee Plan, (ii) the
most recent annual reports (Form 5500) as filed with the
United States Internal Revenue Service (the
IRS), (iii) each trust agreement related
to such Predix Employee Plan, (iv) the most recent summary
plan description for each Predix Employee Plan for which such
description is required, along with all summaries of material
modifications, amendments, resolutions and all other material
plan documentation related thereto, (v) the most recent
actuarial report relating to any Predix Employee Plan subject to
Title IV of ERISA and (vi) the most recent IRS
determination letter issued with respect to any Predix Employee
Plan.
(c) There are no actions or claims pending (other than
routine claims for benefits), or to the knowledge of Predix
threatened, against any Predix Employee Plan or against the
assets of any Predix Employee Plan, nor are there any current,
or to the knowledge of Predix threatened, encumbrances or liens
on the assets of any Predix Employee Plan. Each Predix Employee
Plan which is intended to be qualified under Section 401(a)
of the Code has received a favorable determination for the IRS
covering the provisions of the Tax Reform Act of 1986 and GUST
stating that such Predix Employee Plan is so
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qualified and nothing has occurred since the date of such letter
that could reasonably be expected to affect the qualified status
of such plan. Each Predix Employee Plan has been operated in all
material respects in accordance with its terms and the
requirements of all applicable law.
(d) No Predix Employee Plan is an employee pension
benefit plan (within the meaning of Section 3(2) of
ERISA) subject to Title IV of ERISA, and neither Predix nor
any ERISA Affiliate has ever maintained, contributed to or
partially or fully withdrawn from any such plan. No Predix
Employee Plan is a Multiemployer Plan or single-employer
plan under multiple controlled groups as described in
Section 4063 of ERISA, and neither Predix nor any ERISA
Affiliate has ever contributed to or had an obligation to
contribute, or incurred any liability in respect of a
contribution, to any Multiemployer Plan. No Predix Employee Plan
is a multiple employer plan within the meaning of
Section 413(c) of the Code or Section 3(40) of ERISA.
(e) With respect to the employees and former employees of
Predix, there are no employee post-retirement medical or health
plans or agreements in effect, except as required by
Section 4980B of the Code or similar state law.
(f) Based on Predixs good faith interpretation of the
provisions of Section 409A of the Code and the guidance
issued thereunder, any Predix Employee Plan that is a
nonqualified deferred compensation plan within the
meaning of Section 409A of the Code has been operated in
accordance with the requirements of Section 409A (including
the Notices issued by the IRS thereunder).
2.13. ABSENCE OF LIENS AND
ENCUMBRANCES; CONDITION OF EQUIPMENT. Predix and its
subsidiaries have good and valid title to, or, in the case of
leased properties and assets, valid leasehold interests in, all
material tangible properties and assets, real, personal and
mixed, necessary for use in their business, free and clear of
any liens or encumbrances except as reflected in the Predix
Financials and except for (a) liens for taxes not yet due
and payable; (b) liens which secure a payment not yet due
that arises, and is customarily discharged, in the ordinary
course of Predixs or its subsidiaries business;
(c) liens relating to capitalized lease financings or
purchase money financings that have been entered into in the
ordinary course of business and (d) liens arising solely by
the action of EPIX (collectively, Permitted
Liens). Each of the material tangible assets is in a
good state of maintenance and repair, and in good operating
condition (subject to normal wear and tear) and is suitable for
the purposes for which it presently is used.
2.14. ENVIRONMENTAL MATTERS.
(a) Hazardous Material. No underground
storage tanks and no amount of any substance that has been
designated by any Governmental Authority or by applicable
federal, state or local law, to be radioactive, toxic, hazardous
or otherwise a danger to health or the environment, including,
without limitation, PCBs, asbestos, petroleum, urea-formaldehyde
and all substances listed as hazardous substances pursuant to
the Comprehensive Environmental Response, Compensation, and
Liability Act of 1980, as amended, or defined as a hazardous
waste pursuant to the United States Resource Conservation and
Recovery Act of 1976, as amended, and the regulations
promulgated pursuant to said laws, but excluding office and
janitorial supplies (a Hazardous Material),
are present, as a result of the deliberate actions of Predix or
its subsidiaries, or, to Predixs and its
subsidiaries knowledge, as a result of any actions of any
third party or otherwise, in, on or under any property,
including the land and the improvements, ground water and
surface water thereof, that Predix or any of its subsidiaries
have at any time owned, operated, occupied or leased.
(b) Hazardous Material Activities. Except as
would not reasonably be expected to have a Material Adverse
Effect on Predix, Predix and its subsidiaries have not
transported, stored, used, manufactured, disposed of, released
or exposed their employees or others to Hazardous Materials in
violation of any law in effect on or before the date hereof, nor
has Predix or its subsidiaries disposed of, transported, sold,
or manufactured any product containing a Hazardous Material
(collectively, Hazardous Material Activities)
in violation of any rule, regulation, treaty or statute
promulgated by any Governmental
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Authority in effect prior to or as of the date hereof to
prohibit, regulate or control Hazardous Materials or any
Hazardous Material Activity.
(c) Permits. Predix and its subsidiaries
currently hold all environmental approvals, permits, licenses,
clearances and consents (the Predix Environmental
Permits) necessary for the conduct of Predixs
and its subsidiaries Hazardous Material Activities and
other businesses of Predix and its subsidiaries as such
activities and businesses are currently being conducted, except
where the failure to so hold would not reasonably be expected to
have a Material Adverse Effect on Predix.
(d) Environmental Liabilities. No material
action, proceeding, revocation proceeding, amendment procedure,
writ, injunction or claim is pending, or to the knowledge of
Predix or its subsidiaries, threatened concerning any Predix
Environmental Permit, Hazardous Material or any Hazardous
Material Activity of Predix or its subsidiaries. Neither Predix
or its subsidiaries are aware of any fact or circumstance which
could involve Predix or its subsidiaries in any environmental
litigation or impose upon Predix or its subsidiaries any
environmental liability.
2.15. LABOR MATTERS.
(a) Section 2.15(a) of the Predix Disclosure Schedule
sets forth a true, complete and correct list of all employees of
Predix and its subsidiaries along with their position and actual
annual rate of compensation. All employees have entered into
nondisclosure and assignment of inventions agreements with
Predix or its subsidiaries, true, complete and correct copies of
which have previously been made available to EPIX. To the
knowledge of Predix and its subsidiaries, no employee of Predix
or its subsidiaries is in violation of any term of any patent
disclosure agreement, non-competition agreement, or any
restrictive covenant (i) to Predix or its subsidiaries, or
(ii) to a former employer relating to the right of any such
employee to be employed because of the nature of the business
conducted by Predix or its subsidiaries or to the use of trade
secrets or proprietary information of others. No key employee or
group of employees has threatened to terminate employment with
Predix or its subsidiaries nor, to the knowledge of Predix or
its subsidiaries (which, for purposes of this representation
only, shall mean actual knowledge), has plans to terminate such
employment. Key employees are listed in Schedule 2
hereto.
(b) Neither Predix or any of its subsidiaries are parties
to or bound by any collective bargaining agreement, nor has it
experienced any strikes, grievances, claims of unfair labor
practices or other collective bargaining disputes.
(c) Except as disclosed in Section 2.15(c) of the
Predix Disclosure Schedule, neither Predix or any of its
subsidiaries are parties to any written or oral:
(i) agreement with any current or former employee the
benefits of which are contingent upon, or the terms of which
will be materially altered by, the consummation of the Merger or
other transactions contemplated by this Agreement;
(ii) agreement with any current or former employee of
Predix or its subsidiaries providing any term of employment or
compensation guarantee extending for a period longer than one
year from the date hereof or for the payment of compensation in
excess of $100,000 per annum; or (iii) agreement or
plan the benefits of which will be increased, or the vesting of
the benefits of which will be accelerated, upon the consummation
of the Merger.
2.16. AGREEMENTS, CONTRACTS AND
COMMITMENTS. Predix and its subsidiaries are not parties to
or bound by:
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(a) except as described in Section 2.12(a) of the
Predix Disclosure Schedule, any bonus, deferred compensation,
incentive compensation, pension, profit-sharing or retirement
plans, or any other employee benefit plans or arrangements; |
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(b) except as described in Section 2.12(a) of the
Predix Disclosure Schedule, any employment or consulting
agreement, contract or commitment with any officer or director
level employee, not terminable by Predix or its subsidiaries on
thirty (30) days notice without liability, except to the
extent general principles of wrongful termination law may limit
Predixs or its subsidiaries ability to terminate
employees at will; |
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(c) except as described in Section 2.12(a) of the
Predix Disclosure Schedule, any agreement or plan, including,
without limitation, any stock option plan, stock appreciation
right plan or stock purchase plan, any of the benefits of which
will be increased, or the vesting of benefits of which will be
accelerated, by the occurrence of any of the transactions
contemplated by this Agreement or the value of any of the
benefits of which will be calculated on the basis of any of the
transactions contemplated by this Agreement; |
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(d) any agreement of indemnification or guaranty not
entered into in the ordinary course of business other than
indemnification agreements between Predix or its subsidiaries
and any of their officers or directors; |
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(e) any agreement, contract or commitment containing any
covenant limiting the freedom of Predix or its subsidiaries to
engage in any line of business or compete with any person; |
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(f) any agreement, contract or commitment relating to
capital expenditures and involving future obligations in excess
of $25,000 and not cancelable without penalty; |
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(g) any agreement, contract or commitment currently in
force relating to the disposition or acquisition of assets not
in the ordinary course of business or any ownership interest in
any corporation, partnership, joint venture or other business
enterprise; |
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(h) any mortgages, indentures, loans or credit agreements,
security agreements or other agreements or instruments relating
to the borrowing of money or extension of credit in excess of
$25,000; |
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(i) any joint marketing or development agreement; |
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(j) any distribution agreement (identifying any that
contain exclusivity provisions); or |
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(k) any other agreement, contract or commitment (excluding
real and personal property leases) which involve payment by
Predix or its subsidiaries under any such agreement, contract or
commitment of $25,000 or more in the aggregate. |
Predix and its subsidiaries have not, nor to Predixs or
its subsidiaries knowledge has any other party to a Predix
Contract (as defined below), breached, violated or defaulted
under, or received notice that it has breached, violated, or
defaulted under, any of the terms or conditions of, or
terminated any of the agreements, contracts or commitments to
which Predix or its subsidiaries are a party or by which they
are bound of the type described in clauses (a) through
(k) above (any such agreement, contract or commitment, a
Predix Contract) in such manner as would
permit any other party to cancel or terminate any such Predix
Contract, or would permit any other party to seek damages which
would reasonably be expected to have a Material Adverse Effect
on Predix. As to Predix and its subsidiaries, each Predix
Contract is valid, binding, enforceable and in full force and
effect, except as enforceability may be limited by bankruptcy
and other similar laws and general principles of equity.
2.17. CHANGE OF CONTROL
PAYMENTS. Section 2.17 of the Predix Disclosure
Schedule sets forth each plan or agreement pursuant to which any
material amounts may become payable (whether currently or in the
future) to current or former officers and directors of Predix or
its subsidiaries as a result of or in connection with the Merger.
2.18. BOARD APPROVAL. The
Board of Directors of Predix, as of the date of this Agreement,
has (i) declared the advisability of the Merger and the
Merger Agreement, and (ii) recommended that the
stockholders of Predix approve this Agreement and the Merger.
2.19. BOOKS AND RECORDS. The
minute books of Predix and its subsidiaries made available to
counsel for EPIX are the only minute books of Predix and its
subsidiaries and contain accurate summaries, in all material
respects, of all meetings of directors (or committees thereof)
and stockholders or actions by written consent since the time of
incorporation of Predix and its subsidiaries, as the case may
be. The books and records of Predix and its subsidiaries
accurately reflect in all material respects the
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assets, liabilities, business, financial condition and results
of operations of Predix and its subsidiaries and have been
maintained in accordance with good business and bookkeeping
practices.
2.20. RESTRICTIONS ON BUSINESS
ACTIVITIES. Other than as contemplated by this Agreement,
there is no agreement, judgment, injunction, order or decree
binding upon or otherwise applicable to Predix or its
subsidiaries which has, or would reasonably be expected to have,
the effect of prohibiting or materially impairing (i) any
current business practice of Predix or its subsidiaries; or
(ii) any acquisition of any person or property by Predix or
its subsidiaries.
2.21. REAL PROPERTY LEASES.
Section 2.21 of the Predix Disclosure Schedule sets forth
all real property leases or subleases to or by Predix or its
subsidiaries. Predix has delivered to EPIX true, complete and
correct copies of the leases and subleases (as amended to date)
listed in Section 2.21 of the Predix Disclosure Schedule.
With respect to each lease and sublease listed in
Section 2.21 of the Predix Disclosure Schedule:
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(a) As to Predix or its subsidiaries, each lease or
sublease is legal, valid, binding, enforceable and in full force
and effect, except as enforceability may be limited by
bankruptcy and other similar laws and general principles of
equity; |
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(b) Neither Predix or any of its subsidiaries are in breach
or violation of, or default under, any such lease or sublease,
and no event has occurred, is pending or, to the knowledge of
Predix or its subsidiaries, is threatened, which, after the
giving of notice, with lapse of time, or otherwise, would
constitute a breach or default by Predix or its subsidiaries or,
to the knowledge of Predix and its subsidiaries, any other party
under such lease or sublease, except as would not reasonably be
expected to have a Material Adverse Effect; |
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(c) Neither Predix or its subsidiaries have assigned,
transferred, conveyed, mortgaged, deeded in trust or encumbered
any interest in any lease or sublease; and |
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(d) there are no liens, easements, covenants or other
restrictions applicable to the real property subject to such
lease, except for Permitted Liens. |
2.22. INSURANCE.
(a) Section 2.22(a) of the Predix Disclosure Schedule
sets forth each insurance policy (including fire, theft,
casualty, general liability, workers compensation, business
interruption, environmental, product liability and automobile
insurance policies and bond and surety arrangements) to which
Predix or its subsidiaries are a party (the Insurance
Policies). The Insurance Policies are in full force
and effect, maintained with reputable companies against normal
losses relating to the business, operations and properties and
such other losses as companies engaged in similar business as
Predix or its subsidiaries would, in accordance with good
business practice, customarily insure. All premiums due and
payable under the Insurance Policies have been paid on a timely
basis and Predix and its subsidiaries are in compliance in all
material respects with all other terms thereof. True, complete
and correct copies of the Insurance Policies have been made
available to EPIX.
(b) There are no material claims pending as to which
coverage has been questioned, denied or disputed. All material
claims thereunder have been filed in a due and timely fashion
and neither Predix or any of its subsidiaries have been refused
insurance for which it has applied or had any policy of
insurance terminated (other than at its request), nor has Predix
or its subsidiaries received notice from any insurance carrier
that: (i) such insurance will be canceled or that coverage
thereunder will be reduced or eliminated; or (ii) premium
costs with respect to such insurance will be increased, other
than premium increases in the ordinary course of business
applicable on their terms to all holders of similar policies.
(c) Predix has made available to EPIX accurate and complete
copies of the existing policies (primary and excess) of
directors and officers liability insurance
maintained by Predix as of the date of this Agreement.
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2.23. CERTAIN BUSINESS
PRACTICES. Neither Predix or its subsidiaries nor, to the
knowledge of Predix or its subsidiaries, any director, officer,
employee or agent of Predix or its subsidiaries has:
(i) used any funds for unlawful contributions, gifts,
entertainment or other unlawful payments relating to political
activity; (ii) made any unlawful payment to any foreign or
domestic government official or employee or to any foreign or
domestic political party or campaign or violated any provision
of the Foreign Corrupt Practices Act of 1977, as amended; or
(iii) made any other unlawful payment.
2.24. SUPPLIERS AND
MANUFACTURERS; EFFECT OF TRANSACTION.
(a) Section 2.24(a) of the Predix Disclosure Schedule
sets forth a true, complete and correct list of each supplier
and manufacturer that is the sole supplier or manufacturer of
any material product or service to Predix or its subsidiaries.
Since the Predix Balance Sheet Date, there has not been:
(A) any materially adverse change in the business
relationship of Predix or its subsidiaries with any supplier or
manufacturer named in Section 2.24(a) of the Predix
Disclosure Schedule; or (B) any change in any material term
(including credit terms) of the sales agreements or related
agreements with any supplier or manufacturer named in
Section 2.24(a) of the Predix Disclosure Schedule.
(b) To the knowledge of Predix and its subsidiaries, no
creditor, supplier, employee, client, customer or other person
having a material business relationship with Predix or its
subsidiaries has informed Predix or its subsidiaries that such
person intends to materially change its relationship with Predix
or its subsidiaries because of the transactions contemplated by
this Agreement or otherwise.
2.25. GOVERNMENT CONTRACTS.
Predix and its subsidiaries have not been suspended or debarred
from bidding on contracts with any Governmental Authority, and
no such suspension or debarment has been initiated or
threatened. The consummation of the Merger and other
transactions contemplated by this Agreement will not result in
any such suspension or debarment of Predix or its subsidiaries.
2.26. INTERESTED PARTY
TRANSACTIONS. As of the date hereof, no affiliate of Predix
or its subsidiaries (a) owns any property or right,
tangible or intangible, which is used in the business of Predix
or its subsidiaries, (b) has any claim or cause of action
against Predix or its subsidiaries, or (c) owes any money
to, or is owed any money by, Predix or its subsidiaries.
Section 2.26 of the Predix Disclosure Schedule describes
any material transactions or relationships between Predix and
its subsidiaries and any affiliate thereof that would be
required to be disclosed pursuant to Item 404 of
Regulation S-K
promulgated by the SEC.
2.27. VOTING REQUIREMENTS.
The affirmative vote of the holders of a majority of the voting
power of the outstanding Predix capital stock, on an as
converted to common stock basis, the affirmative vote of the
holders of at least sixty percent (60%) of the outstanding
Predix Preferred Stock, voting together as a single class, and
the affirmative vote of the holders of at least sixty-six and
two-thirds percent
(662/3
%) of the outstanding Series C Preferred Stock,
voting as a separate class, are the only votes of the holders of
any Predix capital stock necessary to approve and adopt this
Agreement and the transactions contemplated hereby.
2.28. REGISTRATION STATEMENT;
JOINT PROXY STATEMENT/ PROSPECTUS. The information to be
supplied by Predix for inclusion in the Registration Statement
shall not at the time the Registration Statement is filed with
the SEC and at the time it becomes effective under the
Securities Act, contain any untrue statement of a material fact
or omit to state any material fact required to be stated therein
or necessary in order to make the statements therein not
misleading. The information to be supplied by Predix for
inclusion in the joint proxy statement/ prospectus to be sent to
the stockholders of Predix and EPIX in connection with the
meeting of Predixs stockholders to consider the approval
of this Agreement and the Merger (the Predix
Stockholders Meeting) and in connection with the
meeting of EPIXs stockholders to consider the approval of
this Agreement, the Merger and the issuance of shares of EPIX
Common Stock pursuant to the terms of the Merger (the
EPIX Stockholders Meeting) (such joint
proxy statement/ prospectus as amended or supplemented is
referred to herein as the Joint Proxy
Statement) shall not, on the date the Joint Proxy
Statement is first mailed to EPIXs stockholders, and
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at the time of the EPIX Stockholders Meeting, contain any
untrue statement of a material fact or omit to state any
material fact required to be stated therein or necessary in
order to make the statements therein, in light of the
circumstances under which they are made, not false or
misleading; or omit to state any material fact necessary to
correct any statement in any earlier communication with respect
to the solicitation of proxies for the EPIX Stockholders
Meeting which has become false or misleading. If at any time
prior to the Effective Time, any event relating to Predix, its
subsidiaries or any of their affiliates, officers or directors
should be discovered by Predix or its subsidiaries which should
be set forth in an amendment to the Registration Statement or a
supplement to the Joint Proxy Statement, Predix shall promptly
inform EPIX of such event. The Joint Proxy Statement will comply
as to form in all material respects with the provisions of the
Exchange Act and the rules and regulations thereunder.
Notwithstanding the foregoing, Predix makes no representation or
warranty with respect to any information supplied by EPIX which
is contained in any of the foregoing documents.
2.29. DISCLOSURE. None of
the representations or warranties of Predix contained herein and
none of the information contained in the Predix Disclosure
Schedule is false or misleading in any material respect or omits
to state a fact herein or therein necessary to make the
statements herein or therein, in light of the circumstance in
which they were made, not misleading in any material respect.
ARTICLE III
REPRESENTATIONS AND WARRANTIES OF EPIX AND MERGER SUB
EPIX and Merger Sub hereby jointly and severally represent and
warrant to Predix as follows, except as set forth in the EPIX
SEC Reports (as defined in Section 3.6 below), or in the
written disclosure schedule delivered by EPIX to Predix (the
EPIX Disclosure Schedule). The EPIX
Disclosure Schedule shall be arranged in sections and
subsections corresponding to the numbered and lettered sections
and subsections contained in this Article III. The
inclusion of any information in the EPIX Disclosure Schedule (or
any update thereto) shall not be deemed to be an admission or
acknowledgment, in and of itself, that such information is
required by the terms hereof to be disclosed, is material, has
resulted in or would result in a Material Adverse Effect, or is
outside the ordinary course of business. For purposes of this
Agreement, the phrase to the knowledge of EPIX or
any phrase of similar import shall mean and be limited to the
actual knowledge of the individuals set forth on
Schedule 3 hereto.
3.1. ORGANIZATION OF EPIX AND
MERGER SUB. Each of EPIX and Merger Sub (a) is a
corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware, (b) has
all requisite corporate power and authority to own, lease and
operate its property and to carry on its business as now being
conducted and as proposed to be conducted, and (c) is duly
qualified to do business and in good standing as a foreign
corporation in each jurisdiction in which the failure to be so
qualified would have a Material Adverse Effect on EPIX. Each of
EPIX and Merger Sub has delivered or made available a true and
correct copy of its respective Certificate of Incorporation and
Bylaws, each as amended to date, as applicable, to Predix.
3.2. OWNERSHIP OF MERGER SUB; NO
PRIOR ACTIVITIES. Merger Sub is a direct, wholly-owned
subsidiary of EPIX and at the Effective Time will cease to exist
pursuant to Section 1.1(a). Merger Sub was formed in
connection with the transactions contemplated by this Agreement
and has engaged in no business activity other than in connection
with the transactions contemplated by this Agreement.
3.3. EPIX AND MERGER SUB CAPITAL
STRUCTURE. The authorized capital stock of EPIX consists of
40,000,000 shares of EPIX Common Stock, of which there were
23,284,810 shares issued and outstanding as of
February 28, 2006 and 1,000,000 shares of Preferred
Stock, par value $.01 per share, none of which were issued
and outstanding as of such date. All outstanding shares of the
EPIX Common Stock are duly authorized, validly issued, fully
paid and non-assessable and are not subject to preemptive rights
created by statute, the Certificate of Incorporation or Bylaws
of EPIX or any agreement or document to which EPIX is a party or
by which it is bound. As of February 28, 2006, EPIX had
reserved
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an aggregate of 4,379,656 shares of EPIX Common Stock, net
of exercises, for issuance to employees and consultants pursuant
to the EPIX Amended and Restated 1992 Incentive Plan (the
EPIX 1992 Plan) under which options were
outstanding for an aggregate of 2,934,164 shares and an
aggregate of 394,668 shares of EPIX Common Stock, net of
exercises, for issuance to non-employee directors pursuant to
the EPIX Amended and Restated 1996 Director Stock Option
Plan (the EPIX 1996 Plan, together with the
EPIX 1992 Plan, the EPIX Stock Plans) under
which options were outstanding for an aggregate of
210,000 shares. As of February 28, 2006, EPIX had
reserved an aggregate of 16,750 shares of EPIX Common Stock
for issuance to employees pursuant to the EPIX Employee Stock
Purchase Plan (the EPIX ESPP). All shares of
the EPIX Common Stock subject to issuance as aforesaid, upon
issuance on the terms and conditions specified in the
instruments pursuant to which they are issuable, would be duly
authorized, validly issued, fully paid and non-assessable.
3.4. OBLIGATIONS WITH RESPECT TO
CAPITAL STOCK. Except as set forth in Section 3.3,
there are no equity securities of any class of EPIX or Merger
Sub, or any securities exchangeable or convertible into or
exercisable for such equity securities, authorized, issued,
reserved for issuance or outstanding. Except for securities EPIX
or Merger Sub owns, directly or indirectly through one or more
subsidiaries, there are no equity securities of any class of any
subsidiary of EPIX or Merger Sub, respectively, or any security
exchangeable or convertible into or exercisable for such equity
securities, issued, reserved for issuance or outstanding. Except
as set forth in Section 3.3 of this Agreement or
Section 3.4 of the EPIX Disclosure Schedule, there are no
options, warrants, equity securities, calls, rights (including
preemptive rights), commitments or agreements or any character
to which EPIX or any of its subsidiaries is a party or by which
they are bound obligating EPIX or any of its subsidiaries to
issue, deliver or sell, or cause to be issued, delivered or
sold, or repurchase, redeem or otherwise acquire, or cause the
repurchase, redemption or acquisition of, any shares of capital
stock of EPIX or Merger Sub or obligating EPIX or Merger Sub to
grant, extend, accelerate the vesting of or enter into any such
option, warrant, equity security, call, right, commitment or
agreement. There are no registration rights and, to the
knowledge of EPIX there are no voting trusts, proxies or other
agreements or understandings with respect to any equity security
of any class of EPIX or Merger Sub.
3.5. AUTHORITY.
(a) Each of EPIX and Merger Sub has all requisite corporate
power and authority to enter into this Agreement and to
consummate the transactions contemplated hereby. The execution
and delivery of this Agreement and the consummation of the
transactions contemplated hereby have been duly authorized by
all necessary corporate action on the part of EPIX and Merger
Sub, subject only to the approval of the Merger by EPIXs
stockholders as contemplated in Section 5.2 and to the
filing and recordation of the Certificate of Merger pursuant to
Delaware Law. This Agreement has been duly executed and
delivered by EPIX and Merger Sub and, assuming the due
authorization, execution and delivery of this Agreement by the
other parties hereto, this Agreement constitutes the valid and
binding obligation of EPIX and Merger Sub, enforceable
against such party in accordance with its terms, except as
enforceability may be limited by bankruptcy and other similar
laws and general principles of equity. The execution and
delivery of this Agreement by EPIX and Merger Sub does not, and
the performance of this Agreement by EPIX and Merger Sub will
not, (i) conflict with or violate the Certificate of
Incorporation or Bylaws of EPIX or Merger Sub, (ii) subject
to obtaining the approval of the Merger by EPIXs
stockholders as contemplated in Section 5.2 and compliance
with the requirements set forth in Section 3.5(b) below,
conflict with or violate any law, rule, regulation, order,
judgment or decree applicable to EPIX or Merger Sub or by which
its properties are bound or affected, or (iii) except as
would not reasonably be expected to have a Material Adverse
Effect and subject to obtaining the consents set forth in
Section 3.5 of the EPIX Disclosure Schedule, result in any
breach of or constitute a default (or an event that with notice
or lapse of time or both would become a default) under, or
impair EPIXs or Merger Subs rights or alter the
rights or obligations of any third party under, or give to
others any rights of termination, amendment, acceleration or
cancellation of, or result in the creation of a lien or
encumbrance on any of the properties or assets of EPIX or Merger
Sub pursuant to, any note, bond, mortgage, indenture, contract,
agreement, lease, license, permit, franchise or other instrument
or obligation to which EPIX or Merger Sub is a party or by which
A-26
EPIX or Merger Sub or each of its properties are bound or
affected, except, with respect to clauses (ii) and (iii),
for any such conflicts, violations, defaults or other
occurrences that would not have a Material Adverse Effect on
EPIX. Section 3.5 of the EPIX Disclosure Schedule lists all
material consents, waivers and approvals under any of
EPIXs or Merger Subs agreements, contracts, licenses
or leases required to be obtained in connection with the
consummation of the transactions contemplated hereby.
(b) No Approval of any person or any Governmental Authority
is required by or with respect to EPIX or Merger Sub in
connection with the execution and delivery of this Agreement or
any related agreements required to be executed by this Agreement
or the consummation of the transactions contemplated hereby and
thereby, except for (i) the filing of the Registration
Statement with the SEC in accordance with the Securities Act,
(ii) the filing of the Certificate of Merger with the
Secretary of State of the State of Delaware, (iii) the
filing of the Joint Proxy Statement with the SEC in accordance
with the Exchange Act, (iv) EPIXs filing of a Current
Report on Form 8-K
with the SEC, (v) the listing of the EPIX Common Stock
issuable pursuant to this Agreement on the NASDAQ,
(vi) such Approvals as may be required under applicable
federal and state securities laws and the laws of any foreign
country including, without limitation, the HSR Act, and
(vii) such other Approvals which, if not obtained or made,
would not have a Material Adverse Effect on EPIX or would not
have a material adverse effect on the ability of the parties
hereto to consummate the Merger.
3.6. EPIX FINANCIAL
STATEMENTS.
(a) EPIX has filed all forms, reports and documents
required to be filed with the SEC since January 1, 2005 and
all such required forms, reports and documents are referred to
herein as the EPIX SEC Reports. As of their
respective dates, the EPIX SEC Reports (i) were prepared in
accordance with the requirements of the Securities Act or the
Securities Exchange Act of 1934, as amended (the
Exchange Act), as the case may be, and the
rules and regulations of the SEC thereunder applicable to such
EPIX SEC Reports, and (ii) did not at the time they were
filed (or if amended or superseded by a filing prior to the date
of this Agreement, then on the date of such filing) contain any
untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary in order to make
the statements therein, in the light of the circumstances under
which they were made, not misleading. The certifications and
statements required by
(A) Rule 13a-14
under the Exchange Act and (B) 18 U.S.C. §1350
(Section 906 of the Sarbanes-Oxley Act) relating to the
EPIX SEC Reports are accurate and complete and comply as to form
and content with all applicable legal requirements.
(b) The audited financial statements (including any related
notes thereto) contained in the EPIX SEC Reports or delivered to
Predix representing the balance sheet of EPIX at
December 31, 2005 and the statements of operations,
stockholders equity and cash flows for the three-year
period then ended (the EPIX Financials),
(x) complied with the published rules and regulations of
the SEC with respect thereto, (y) were prepared in
accordance with GAAP applied on a consistent basis throughout
the periods involved (except as may be indicated in the notes
thereto) and (z) fairly presented the results of its
operations and cash flows for the periods indicated. The balance
sheet of EPIX as of December 31, 2005 is hereinafter
referred to as the EPIX Balance Sheet. Except
as disclosed in the EPIX Financials, EPIX has no liabilities
(absolute, accrued, contingent or otherwise) of a nature
required to be disclosed on a balance sheet or in the related
notes to the financial statements prepared in accordance with
GAAP which are, individually or in the aggregate, material to
the business, results of operations or financial condition of
EPIX except liabilities (i) provided for in the EPIX
Balance Sheet, or (ii) incurred since the date of the EPIX
Balance Sheet in the ordinary course of business consistent with
past practices in both type and amount.
(c) EPIX maintains adequate disclosure controls and
procedures designed to ensure that material information relating
to EPIX, is made known to the Chief Executive Officer and the
Principal Accounting Officer of EPIX by others within that
entity. To EPIXs knowledge, there are no
(i) significant deficiencies and material weaknesses in the
design or operation of internal controls over financial
reporting which are reasonably likely to adversely affect in any
material respect EPIXs ability to record, process,
summarize and report financial information and (ii) fraud,
or allegation of fraud, whether or not material,
A-27
that involves management or other employees who have a
significant role in EPIXs internal controls over financial
reporting.
(d) EPIX maintains a system of internal accounting controls
designed to provide reasonable assurance that:
(i) transactions are executed in accordance with
managements general or specific authorizations;
(ii) transactions are recorded as necessary to permit
preparation of financial statements in conformity with GAAP
principles and to maintain asset accountability;
(iii) access to assets is permitted only in accordance with
managements general or specific authorization; and
(iv) the recorded accountability for assets is compared
with the existing assets at reasonable intervals and appropriate
action is taken with respect to any differences.
3.7. ABSENCE OF CERTAIN CHANGES
OR EVENTS. Since the date of the EPIX Balance Sheet through
the date of this Agreement, EPIX has conducted its business only
in the ordinary course of business consistent with past
practice, and there has not been: (i) any event that has
had, or that would be reasonably expected to result in, a
Material Adverse Effect on EPIX, (ii) any material change
by EPIX in its accounting methods, principles or practices,
except as required by concurrent changes in GAAP, (iii) any
revaluation or disposition by EPIX of any of its assets having a
Material Adverse Effect on EPIX or (iv) any other action,
event or occurrence that would have required the consent of
Predix pursuant to Section 4.3 of this Agreement had such
action, event or occurrence taken place after the execution and
delivery of this Agreement.
3.8. TAXES. EPIX has
accurately prepared and timely filed or had prepared and timely
filed on its behalf all returns, declarations, reports,
statements, information statements and other documents filed or
required to be filed (EPIX Tax Returns) with
respect to any and all federal, state, local and foreign taxes,
assessments and other governmental charges, duties, impositions
and liabilities, including, without limitation, taxes based upon
or measured by gross receipts, income, profits, sales, use and
occupation, value added, ad valorem, transfer, franchise,
withholding, payroll, recapture, employment, excise and property
taxes, together with all interest, penalties and additions
imposed with respect to such amounts and any obligations under
any agreements or arrangements with any other person with
respect to such amounts and including any liability for taxes of
a predecessor entity concerning or attributable to EPIX or to
their operations (EPIX Taxes), and all such
Tax Returns are true, complete and correct in all material
respects. Copies of all such returns filed after January 1,
2003 have been delivered to Predix.
In addition:
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(a) EPIX: (i) have paid all Taxes they are obligated
to pay as reflected on the Tax Returns or otherwise; and
(ii) have withheld all federal, state, local and foreign
Taxes required to be withheld with respect to their employees or
otherwise. |
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(b) There is no Tax deficiency outstanding, proposed or
assessed against EPIX and its subsidiaries that is not
accurately reflected as a liability on the EPIX Balance Sheet,
nor has EPIX executed any waiver of any statute of limitations
on or extending the period for the assessment or collection of
any Tax. |
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(c) EPIX does not have any liability for unpaid Taxes that
has not been properly accrued for under GAAP and reserved for on
the EPIX Balance Sheet, whether asserted or unasserted,
contingent or otherwise. |
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(d) EPIX is not a party to any agreement, plan, arrangement
or other contract covering any employee or independent
contractor or former employee or independent contractor that,
individually or collectively with any other such contracts,
would reasonably be expected to give rise directly or indirectly
to the payment of any amount that would not be deductible
pursuant to Section 280G or Section 162(m) of the Code
(or any comparable provision of state or foreign tax laws). |
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(e) EPIX is not, nor has ever been, a party to or bound by
any tax indemnity agreement, tax sharing agreement, tax
allocation agreement or similar contract or agreement. |
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3.9. BROKERS AND
FINDERS FEES. Other than Needham & Company,
LLC and Chestnut Securities, Inc., EPIX has not incurred, nor
will it incur, directly or indirectly, any liability for
brokerage or finders fees or agents commissions or
any similar charges in connection with this Agreement or any
transaction contemplated hereby.
3.10. BOARD APPROVAL. The
Boards of Directors of EPIX and Merger Sub, as of the date of
this Agreement, have approved this Agreement and the Merger. The
Board of Directors of Merger Sub has declared the advisability
of the Agreement and the Merger and recommended to the
stockholders of Merger Sub to approve the Agreement and the
Merger. The Board of Directors of EPIX has approved the issuance
of the EPIX Common Stock in the Merger. The Board of Directors
of EPIX has, as of the date of this Agreement, determined to
recommend that the stockholders of EPIX approve this Agreement
and the Merger and the issuance of the EPIX Common Stock in the
Merger.
3.11. VALID ISSUANCE. The
EPIX Common Stock to be issued in the Merger, when issued in
accordance with the provisions of this Agreement, shall be
validly issued, fully paid and non-assessable, and shall be
issued in compliance with all federal and state securities laws.
3.12. VOTING REQUIREMENTS.
The affirmative vote of the holders of a majority of the voting
power of the outstanding capital stock of EPIX is required to
approve this Agreement, the Merger and the Issuance of the EPIX
Common Stock as a result of the Merger. The affirmative vote of
the holders of a majority of the voting power of the outstanding
capital stock of Merger Sub has approved the Merger.
3.13. FAIRNESS OPINION. The
Board of Directors of EPIX has received the written opinion of
Needham & Company, LLC, financial advisor to EPIX,
dated March 30, 2006, to the effect that the consideration
payable by EPIX in the Merger is fair to EPIX and its
stockholders from a financial point of view.
3.14. INTELLECTUAL PROPERTY.
(a) EPIX owns, or has the right to use, sell or license,
and has the right to bring actions for the infringement of, all
intellectual property utilized in its business as presently
conducted, which intellectual property is listed on
Section 3.14 of the EPIX Disclosure Schedule (such
intellectual property and the rights thereto are collectively
referred to herein as the EPIX IP Rights),
except for any failure to own or have the right to use, sell or
license that would not reasonably be expected to have a Material
Adverse Effect on EPIX.
(b) The execution, delivery and performance of this
Agreement and the consummation of the transactions contemplated
hereby will not constitute a breach of any instrument or
agreement governing any EPIX IP Rights (the EPIX IP
Rights Agreements), will not cause the forfeiture or
termination or give rise to a right of forfeiture or termination
of any EPIX IP Rights or impair the right of EPIX or the
Surviving Corporation to use, sell or license any EPIX IP Rights
or portion thereof, except for the occurrence of any such
breach, forfeiture, termination or impairment that would not
individually or in the aggregate, reasonably be expected to
result in a Material Adverse Effect on EPIX. Each of the EPIX IP
Rights Agreements (i) is valid and binding on EPIX and in
full force and effect; (ii) EPIX has not received any
notice of termination or cancellation under such agreement, or
received any notice of breach or default under such agreement,
which breach has not been cured or waived; and (iii) EPIX,
and to the knowledge of EPIX, any other party to such agreement,
is not in breach or default thereof in any material respect.
(c) (i) Neither the manufacture, marketing, license,
sale or intended use of any product or technology currently
licensed or sold or under development by EPIX violates any
license or agreement between EPIX and any third party or, to the
knowledge of EPIX, infringes any intellectual property right of
any other party; (ii) to the knowledge of EPIX, no third
party is infringing upon, or violating any license or agreement
with EPIX relating to any EPIX IP Rights; and (iii) to the
knowledge of EPIX, there is no pending or threatened claim or
litigation contesting the validity, ownership or right to use,
sell, license or dispose of any EPIX IP Rights, nor has EPIX
received any written notice asserting that any
A-29
EPIX IP Rights or the proposed use, sale, license or disposition
thereof conflicts or will conflict with the rights of any other
party.
(d) EPIX has used reasonable efforts to maintain its
material trade secrets in confidence, including entering into
licenses and contracts that generally require licensees,
contractors and other third persons with access to such trade
secrets to keep such trade secrets confidential and has
otherwise taken reasonable and practicable steps designed to
safeguard and maintain the secrecy and confidentiality of, and
its proprietary rights in, all EPIX IP Rights.
3.15. COMPLIANCE; PERMITS;
RESTRICTIONS.
(a) EPIX is not in conflict with, or in default or
violation of (i) any law, rule, regulation, order, judgment
or decree applicable to it or by which its properties are bound
or affected, or (ii) any note, bond, mortgage, indenture,
contract, agreement, lease, license, permit, franchise or other
instrument or obligation to which EPIX is a party or by which
EPIX or its properties are bound or affected, except for any
conflicts, defaults or violations which would not reasonably be
expected to have a Material Adverse Effect on EPIX. No
investigation or review by any governmental or regulatory body
or authority is pending or, to the knowledge of EPIX, threatened
against EPIX, nor has any governmental or regulatory body or
authority indicated to EPIX an intention to conduct the same.
(b) EPIX holds all permits, licenses, variances,
exemptions, orders and approvals from governmental authorities
which are material to the operation of its business
(collectively, the EPIX Permits). EPIX is in
compliance with the terms of the EPIX Permits, except where the
failure to so comply would not reasonably be expected to have a
Material Adverse Effect on EPIX. No action, proceeding,
revocation proceeding, amendment procedure, writ, injunction or
claim is pending or, to the knowledge of EPIX, threatened, which
seeks to revoke or limit any EPIX Permit. A true, complete and
correct list of the material EPIX Permits is set forth in
Section 3.15 of the EPIX Disclosure Schedule. The rights
and benefits of each material EPIX Permit will be available to
the Surviving Corporation or its subsidiaries immediately after
the Effective Time on terms substantially identical to those
enjoyed by EPIX immediately prior to the Effective Time.
(c) All products being manufactured, distributed, developed
or tested by or on behalf of EPIX (EPIX
Products) that are subject to the jurisdiction of the
FDA are being manufactured, labeled, stored, tested,
distributed, and marketed in compliance in all material respects
with all applicable requirements under the FDCA, the Public
Health Service Act, their applicable implementing regulations,
and all comparable state laws and regulations.
(d) All clinical trials conducted by or on behalf of EPIX
are being conducted in material compliance with the applicable
requirements of Good Clinical Practice, Informed Consent, and
all applicable requirements relating to protection of human
subjects contained in 21 CFR Parts 50, 54, and 56.
(e) All manufacturing operations for EPIX Products
conducted by or for the benefit of EPIX are being conducted in
accordance, in all material respects, with the FDAs
current Good Manufacturing Practices. In addition, EPIX is in
material compliance with all applicable registration and listing
requirements set forth in 21 U.S.C. Section 360 and
21 CFR Part 207 and all similar applicable laws and
regulations.
(f) Neither EPIX, nor any representative of EPIX, nor, to
the knowledge of EPIX, any of EPIXs licensees or assignees
of EPIX IP Rights has received any notice that the FDA or any
other Governmental Authority has initiated, or threatened to
initiate, any action to suspend any clinical trial sponsored by
EPIX or otherwise restrict the preclinical research on or
clinical study of any EPIX Product being developed by any
licensee or assignee of EPIX IP Rights based on such
intellectual property, or to recall, suspend or otherwise
restrict the development or manufacture of any EPIX Product.
(g) Neither EPIX, nor, to the knowledge of EPIX, any of its
officers, employees, agents or clinical investigators acting for
EPIX has committed any act, made any statement or failed to make
any statement that would reasonably be expected to provide a
basis for the FDA to invoke its policy with respect to
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Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities set forth in 56 Fed. Reg. 46191
(September 10, 1991) and any amendments thereof.
Additionally, neither EPIX, nor, to the knowledge of EPIX, any
of its officers, key employees or agents has been convicted of
any crime or engaged in any conduct that would reasonably be
expected to result in (i) debarment under 21 U.S.C.
Section 335a or any similar state law or
(ii) exclusion under 42 U.S.C.
Section 1320a-7 or
any similar state law or regulation.
(h) All animal studies or other preclinical tests performed
as the basis for any regulatory approval required for the EPIX
Products (1) either (x) have been conducted in
accordance, in all material respects, with applicable Good
Laboratory Practice requirements contained in 21 CFR
Part 58, or (y) were not required to be conducted in
accordance with Good Laboratory Practice requirements contained
in 21 CFR Part 58 and (2) have employed the
procedures and controls generally used by qualified experts in
animal or preclinical study of products comparable to those
being developed by EPIX.
(i) EPIX has made available to Predix copies of any and all
written notices of inspectional observations, establishment
inspection reports and any other documents received from the
FDA, that indicate or suggest lack of compliance with the
regulatory requirements of the FDA. EPIX has made available to
Predix for review all correspondence to or from the FDA, minutes
of meetings, written reports of phone conversations, visits or
other contact with the FDA, notices of inspectional
observations, establishment inspection reports, and all other
documents concerning communications to or from the FDA, or
prepared by the FDA or which bear in any way on EPIXs
compliance with regulatory requirements of the FDA, or on the
likelihood of timing of approval of any EPIX Products.
(j) There are no proceedings pending with respect to a
violation by EPIX of the FDCA, FDA regulations adopted
thereunder, the Controlled Substance Act or any other
legislation or regulation promulgated by any other United States
Governmental Authority.
3.16. LITIGATION. Except as
described in Section 3.16 of the EPIX Disclosure Schedule,
as of the date of this Agreement, there is no action, suit,
proceeding, claim, arbitration or investigation pending, or as
to which EPIX has received any written notice of assertion, nor,
to the knowledge of EPIX, is there any threatened action, suit,
proceeding, claim for arbitration or investigation against EPIX,
which, if adversely determined, would have a Material Adverse
Effect on EPIX.
3.17. EMPLOYEE BENEFIT PLANS.
(a) Section 3.17 of the EPIX Disclosure Schedule lists
all written and describes all non-written employee benefit plans
of ERISA and all bonus, stock or other security option, stock or
other security purchase, stock or other security appreciation
rights, incentive, deferred compensation, retirement or
supplemental retirement, profit sharing, severance, golden
parachute, vacation, cafeteria, dependent care, medical care,
employee assistance program, education or tuition assistance
programs, insurance and other similar fringe or employee benefit
plans, programs or arrangements, and any current or former
employment or executive compensation or severance agreements,
written or otherwise, which are currently sponsored, maintained,
contributed to or entered into for the benefit of, or relating
to, any present or former employee or director of EPIX, or any
trade or business (whether or not incorporated) which is a
member of a controlled group or which is under common control
with Predix within the meaning of Section 414 of the Code
(an ERISA Affiliate), whether or not such
plan is terminated (collectively, the EPIX Employee
Plans).
(b) With respect to each EPIX Employee Plan, EPIX has
provided to Predix a true and complete copy of, to the extent
applicable, (i) such EPIX Employee Plan, (ii) the most
recent annual reports (Form 5500) as filed with the IRS,
(iii) each trust agreement related to such EPIX Employee
Plan, (iv) the most recent summary plan description for
each EPIX Employee Plan for which such description is required,
along with all summaries of material modifications, amendments,
resolutions and all other material plan documentation related
thereto, (v) the most recent actuarial report relating to
any EPIX Employee Plan subject to Title IV of ERISA and
(vi) the most recent IRS determination letter issued with
respect to any EPIX Employee Plan.
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(c) There are no actions or claims pending (other than
routine claims for benefits), or to the knowledge of EPIX
threatened, against any EPIX Employee Plan or against the assets
of any EPIX Employee Plan, nor are there any current, or to the
knowledge of EPIX threatened, encumbrances or liens on the
assets of any EPIX Employee Plan. Each EPIX Employee Plan which
is intended to be qualified under Section 401(a) of the
Code has received a favorable determination for the IRS covering
the provisions of the Tax Reform Act of 1986 and GUST stating
that such EPIX Employee Plan is so qualified and nothing has
occurred since the date of such letter that could reasonably be
expected to affect the qualified status of such plan. Each EPIX
Employee Plan has been operated in all material respects in
accordance with its terms and the requirements of all applicable
law.
(d) No EPIX Employee Plan is an employee pension
benefit plan (within the meaning of Section 3(2) of
ERISA) subject to Title IV of ERISA, and neither EPIX nor
any ERISA Affiliate has ever maintained, contributed to or
partially or fully withdrawn from any such plan. No EPIX
Employee Plan is a Multiemployer Plan or single-employer
plan under multiple controlled groups as described in
Section 4063 of ERISA, and neither EPIX nor any ERISA
Affiliate has ever contributed to or had an obligation to
contribute, or incurred any liability in respect of a
contribution, to any Multiemployer Plan. No Predix Employee Plan
is a multiple employer plan within the meaning of
Section 413(c) of the Code or Section 3(40) of ERISA.
(e) With respect to the employees and former employees of
EPIX, there are no employee post-retirement medical or health
plans or agreements in effect, except as required by
Section 4980B of the Code or similar state law.
(f) Based on EPIXs good faith interpretation of the
provisions of Section 409A of the Code and the guidance
issued thereunder, any EPIX Employee Plan that is a
nonqualified deferred compensation plan within the
meaning of Section 409A of the Code has been operated in
accordance with the requirements of Section 409A (including
the Notices issued by the IRS thereunder).
3.18. ABSENCE OF LIENS AND
ENCUMBRANCES; CONDITION OF EQUIPMENT. EPIX has good and
valid title to, or, in the case of leased properties and assets,
valid leasehold interests in, all material tangible properties
and assets, real, personal and mixed, necessary for use in its
business, free and clear of any liens or encumbrances except as
reflected in the EPIX Financials and except for (a) liens
for taxes not yet due and payable; (b) liens which secure a
payment not yet due that arises, and is customarily discharged,
in the ordinary course of EPIXs business; (c) liens
relating to capitalized lease financings or purchase money
financings that have been entered into in the ordinary course of
business and (d) liens arising solely by the action of
Predix (collectively, Permitted Liens). Each
of the material tangible assets is in a good state of
maintenance and repair, and in good operating condition (subject
to normal wear and tear) and is suitable for the purposes for
which it presently is used.
3.19. ENVIRONMENTAL MATTERS.
(a) Hazardous Material. No underground
storage tanks and no amount of any Hazardous Materials are
present, as a result of the deliberate actions of EPIX, or, to
EPIXs knowledge, as a result of any actions of any third
party or otherwise, in, on or under any property, including the
land and the improvements, ground water and surface water
thereof, that EPIX has at any time owned, operated, occupied or
leased.
(b) Hazardous Material Activities. Except as
would not reasonably be expected to have a Material Adverse
Effect on EPIX, EPIX has not engaged in any Hazardous Material
Activities in violation of any rule, regulation, treaty or
statute promulgated by any Governmental Authority in effect
prior to or as of the date hereof to prohibit, regulate or
control Hazardous Materials or any Hazardous Material Activity.
(c) Permits. EPIX currently holds all
environmental approvals, permits, licenses, clearances and
consents (the EPIX Environmental Permits)
necessary for the conduct of EPIXs Hazardous Material
Activities and other businesses of EPIX as such activities and
businesses are currently being conducted, except where the
failure to so hold would not reasonably be expected to have a
Material Adverse Effect on EPIX.
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(d) Environmental Liabilities. No material
action, proceeding, revocation proceeding, amendment procedure,
writ, injunction or claim is pending, or to the knowledge of
EPIX, threatened concerning any EPIX Environmental Permit,
Hazardous Material or any Hazardous Material Activity of EPIX.
3.20. LABOR MATTERS.
(a) Section 3.20 of the EPIX Disclosure Schedule sets
forth a true, complete and correct list of all employees of EPIX
along with their position and actual annual rate of
compensation. All employees have entered into nondisclosure and
assignment of inventions agreements with EPIX, true, complete
and correct copies of which have previously been made available
to Predix. To the knowledge of EPIX, no employee of EPIX is in
violation of any term of any patent disclosure agreement,
non-competition agreement, or any restrictive covenant
(i) to EPIX, or (ii) to a former employer relating to
the right of any such employee to be employed because of the
nature of the business conducted by EPIX or to the use of trade
secrets or proprietary information of others. No key employee or
group of employees has threatened to terminate employment with
EPIX nor, to the knowledge of EPIX (which, for purposes of this
representation only, shall mean actual knowledge), has plans to
terminate such employment. Key employees are listed in
Schedule 4 hereto.
(b) EPIX is not a party to or bound by any collective
bargaining agreement, nor has it experienced any strikes,
grievances, claims of unfair labor practices or other collective
bargaining disputes.
(c) Except as disclosed in Section 3.20 of the EPIX
Disclosure Schedule, EPIX is not a party to any written or oral:
(i) agreement with any current or former employee the
benefits of which are contingent upon, or the terms of which
will be materially altered by, the consummation of the Merger or
other transactions contemplated by this Agreement;
(ii) agreement with any current or former employee of EPIX
providing any term of employment or compensation guarantee
extending for a period longer than one year from the date hereof
or for the payment of compensation in excess of
$100,000 per annum; or (iii) agreement or plan the
benefits of which will be increased, or the vesting of the
benefits of which will be accelerated, upon the consummation of
the Merger.
3.21. AGREEMENTS, CONTRACTS AND
COMMITMENTS. EPIX is not a party to or bound by:
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(a) except as described in Section 3.17 of the EPIX
Disclosure Schedule, any bonus, deferred compensation, incentive
compensation, pension, profit-sharing or retirement plans, or
any other employee benefit plans or arrangements; |
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(b) except as described in Section 3.17 of the EPIX
Disclosure Schedule, any employment or consulting agreement,
contract or commitment with any officer or director level
employee, not terminable by EPIX on thirty (30) days notice
without liability, except to the extent general principles of
wrongful termination law may limit EPIXs ability to
terminate employees at will; |
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(c) except as described in Section 3.17 of the EPIX
Disclosure Schedule, any agreement or plan, including, without
limitation, any stock option plan, stock appreciation right plan
or stock purchase plan, any of the benefits of which will be
increased, or the vesting of benefits of which will be
accelerated, by the occurrence of any of the transactions
contemplated by this Agreement or the value of any of the
benefits of which will be calculated on the basis of any of the
transactions contemplated by this Agreement; |
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(d) any agreement of indemnification or guaranty not
entered into in the ordinary course of business other than
indemnification agreements between EPIX and any of their
officers or directors; |
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(e) any agreement, contract or commitment containing any
covenant limiting the freedom of EPIX to engage in any line of
business or compete with any person; |
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(f) any agreement, contract or commitment relating to
capital expenditures and involving future obligations in excess
of $25,000 and not cancelable without penalty; |
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(g) any agreement, contract or commitment currently in
force relating to the disposition or acquisition of assets not
in the ordinary course of business or any ownership interest in
any corporation, partnership, joint venture or other business
enterprise; |
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(h) any mortgages, indentures, loans or credit agreements,
security agreements or other agreements or instruments relating
to the borrowing of money or extension of credit in excess of
$25,000; |
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(i) any joint marketing or development agreement; |
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(j) any distribution agreement (identifying any that
contain exclusivity provisions); or |
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(k) any other agreement, contract or commitment (excluding
real and personal property leases) which involve payment by EPIX
under any such agreement, contract or commitment of $25,000 or
more in the aggregate. |
EPIX has not, nor to EPIXs knowledge has any other party
to an EPIX Contract (as defined below), breached, violated or
defaulted under, or received notice that it has breached,
violated, or defaulted under, any of the terms or conditions of,
or terminated any of the agreements, contracts or commitments to
which EPIX is a party or by which they are bound of the type
described in clauses (a) through (k) above (any such
agreement, contract or commitment, a EPIX
Contract) in such manner as would permit any other
party to cancel or terminate any such EPIX Contract, or would
permit any other party to seek damages which would reasonably be
expected to have a Material Adverse Effect on EPIX. As to EPIX,
each EPIX Contract is valid, binding, enforceable and in full
force and effect, except as enforceability may be limited by
bankruptcy and other similar laws and general principles of
equity.
3.22. SEVERANCE PAYMENTS.
Section 3.22 of the EPIX Disclosure Schedule sets forth
each plan or agreement pursuant to which any material amounts
may become payable (whether currently or in the future) to
current or former officers and directors of EPIX as a result of
or in connection with the Merger.
3.23. BOOKS AND RECORDS. The
minute books of EPIX made available to counsel for Predix are
the only minute books of EPIX and contain accurate summaries, in
all material respects, of all meetings of directors (or
committees thereof) and stockholders or actions by written
consent since the time of incorporation of EPIX. The books and
records of EPIX accurately reflect in all material respects the
assets, liabilities, business, financial condition and results
of operations of EPIX and have been maintained in accordance
with good business and bookkeeping practices.
3.24. RESTRICTIONS ON BUSINESS
ACTIVITIES. Other than as contemplated by this Agreement,
there is no agreement, judgment, injunction, order or decree
binding upon or otherwise applicable to EPIX which has, or would
reasonably be expected to have, the effect of prohibiting or
materially impairing (i) any current business practice of
EPIX; or (ii) any acquisition of any person or property by
EPIX.
3.25. REAL PROPERTY LEASES.
Section 3.25 of the EPIX Disclosure Schedule sets forth all
real property leases or subleases to or by EPIX. EPIX has
delivered to Predix true, complete and correct copies of the
leases and subleases (as amended to date) listed in
Section 3.25 of the EPIX Disclosure Schedule. With respect
to each lease and sublease listed in Section 3.25 of the
EPIX Disclosure Schedule:
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(a) As to EPIX, each lease or sublease is legal, valid,
binding, enforceable and in full force and effect, except as
enforceability may be limited by bankruptcy and other similar
laws and general principles of equity; |
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(b) EPIX is not in breach or violation of, or default
under, any such lease or sublease, and no event has occurred, is
pending or, to the knowledge of EPIX, is threatened, which,
after the giving of notice, with lapse of time, or otherwise,
would constitute a breach or default by EPIX or, to the
knowledge of EPIX, any other party under such lease or sublease,
except as would not reasonably be expected to have a Material
Adverse Effect; |
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(c) EPIX has not assigned, transferred, conveyed,
mortgaged, deeded in trust or encumbered any interest in any
lease or sublease; and |
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(d) there are no liens, easements, covenants or other
restrictions applicable to the real property subject to such
lease, except for Permitted Liens. |
3.26. INSURANCE.
(a) Section 3.26(a) of the EPIX Disclosure Schedule
sets forth each insurance policy (including fire, theft,
casualty, general liability, workers compensation, business
interruption, environmental, product liability and automobile
insurance policies and bond and surety arrangements) to which
EPIX is a party (the EPIX Insurance
Policies). The EPIX Insurance Policies are in full
force and effect, maintained with reputable companies against
normal losses relating to the business, operations and
properties and such other losses as companies engaged in similar
business as EPIX would, in accordance with good business
practice, customarily insure. All premiums due and payable under
the EPIX Insurance Policies have been paid on a timely basis and
EPIX is in compliance in all material respects with all other
terms thereof. True, complete and correct copies of the EPIX
Insurance Policies have been made available to Predix.
(b) There are no material claims pending as to which
coverage has been questioned, denied or disputed. All material
claims thereunder have been filed in a due and timely fashion
and EPIX has not been refused insurance for which it has applied
or had any policy of insurance terminated (other than at its
request), nor has EPIX received notice from any insurance
carrier that: (i) such insurance will be canceled or that
coverage thereunder will be reduced or eliminated; or
(ii) premium costs with respect to such insurance will be
increased, other than premium increases in the ordinary course
of business applicable on their terms to all holders of similar
policies.
(c) EPIX has made available to Predix accurate and complete
copies of the existing policies (primary and excess) of
directors and officers liability insurance
maintained by EPIX as of the date of this Agreement.
3.27. CERTAIN BUSINESS
PRACTICES. Neither EPIX nor, to the knowledge of EPIX, any
director, officer, employee or agent of EPIX has: (i) used
any funds for unlawful contributions, gifts, entertainment or
other unlawful payments relating to political activity;
(ii) made any unlawful payment to any foreign or domestic
government official or employee or to any foreign or domestic
political party or campaign or violated any provision of the
Foreign Corrupt Practices Act of 1977, as amended; or
(iii) made any other unlawful payment.
3.28. SUPPLIERS AND
MANUFACTURERS; EFFECT OF TRANSACTION.
(a) Section 3.28 of the EPIX Disclosure Schedule sets
forth a true, complete and correct list of each supplier and
manufacturer that is the sole supplier or manufacturer of any
material product or service to EPIX. Since the EPIX Balance
Sheet Date, there has not been: (A) any materially adverse
change in the business relationship of EPIX with any supplier or
manufacturer named in the EPIX Disclosure Schedule; or
(B) any change in any material term (including credit
terms) of the sales agreements or related agreements with any
supplier or manufacturer named in Section 3.28 of the EPIX
Disclosure Schedule.
(b) To the knowledge of EPIX, no creditor, supplier,
employee, client, customer or other person having a material
business relationship with EPIX has informed EPIX that such
person intends to materially change its relationship with EPIX
because of the transactions contemplated by this Agreement or
otherwise.
3.29. GOVERNMENT CONTRACTS.
EPIX has not been suspended or debarred from bidding on
contracts with any Governmental Authority, and no such
suspension or debarment has been initiated or threatened. The
consummation of the Merger and other transactions contemplated
by this Agreement will not result in any such suspension or
debarment of EPIX.
3.30. INTERESTED PARTY
TRANSACTIONS. As of the date hereof, no affiliate of EPIX
(a) owns any property or right, tangible or intangible,
which is used in the business of EPIX, (b) has any
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claim or cause of action against EPIX, or (c) owes any
money to, or is owed any money by, EPIX. Except as set forth in
the EPIX SEC Documents, since the date of EPIXs last proxy
statement filed with the SEC, no event has occurred that would
be required to be reported by EPIX pursuant to Item 404 of
Regulation S-K
promulgated by the SEC.
3.31. REGISTRATION STATEMENT;
JOINT PROXY STATEMENT/ PROSPECTUS. The Registration
Statement shall not at the time it becomes effective under the
Securities Act, contain any untrue statement of a material fact
or omit to state any material fact required to be stated therein
or necessary in order to make the statements therein not
misleading. The Registration Statement shall, as of the time it
becomes effective under the Securities Act be prepared in
accordance with the requirements of the Securities Act and the
rules and regulations of the SEC thereunder applicable thereto.
The information in the Joint Proxy Statement shall not, on the
date the Joint Proxy Statement is first mailed to Predixs
stockholders, and at the time of the Predix Stockholders
Meeting, contain any untrue statement of a material fact or omit
to state any material fact required to be stated therein or
necessary in order to make the statements therein, in light of
circumstances under which they are made, not false or
misleading; or omit to state any material fact necessary to
correct any statement in any earlier communication with respect
to the solicitation of proxies for the Predix Stockholders
Meeting which has become false or misleading. The Joint Proxy
Statement will comply as to form in all material respect with
the provisions of the Exchange Act and the rules and regulations
thereunder. If at any time prior to the Effective Time, any
event relating to EPIX or any of its affiliates, officers or
directors should be discovered by EPIX which should be set forth
in an amendment to the Registration Statement or a supplement to
the Joint Proxy Statement, EPIX shall promptly inform Predix,
and EPIX shall promptly commence preparation of such amendment
or supplement in accordance with Section 5.01.
Notwithstanding the foregoing, EPIX makes no representation or
warranty with respect to any information supplied by Predix and
its subsidiaries which is contained in any of the foregoing
documents.
3.32. DISCLOSURE. None of
the representations or warranties of EPIX contained herein and
none of the information contained in the EPIX Disclosure
Schedule is false or misleading in any material respect or omits
to state a fact herein or therein necessary to make the
statements herein or therein, in light of the circumstance in
which they were made, not misleading in any material respect.
ARTICLE IV
CONDUCT OF BUSINESS PENDING THE MERGER
4.1. CONDUCT OF BUSINESS BY
PREDIX. Predix covenants and agrees that between the date
hereof and the earlier of a termination of this Agreement in
accordance with its terms or the Effective Time, Predix shall
not, and shall not permit each of its subsidiaries to, conduct
its business other than in the ordinary course and consistent
with past practice. Without limiting the generality of the
foregoing, Predix shall, and shall cause each of its
subsidiaries to, (i) continue its research and development,
clinical investigation and activities relating to the Predix IP
Rights in accordance with past practice; (ii) use its
commercially reasonable efforts to (A) preserve intact its
business organization, (B) keep available to EPIX the
services of its officers, employees and consultants,
(C) continue in full force and effect without material
modification all existing policies or binders of insurance
currently maintained in respect of Predix or its subsidiaries
and their business and (D) preserve its current
relationships with its clinical investigators, suppliers,
manufacturers and other persons with which it has significant
business relationships; and (iii) not modify, amend, renew
or replace, without providing prior notice to EPIX and receiving
EPIXs prior written approval, any agreements set forth in
Section 4.1 of the Predix Disclosure Schedule. In addition,
except as set forth in Section 4.1 of the Predix Disclosure
Schedule or as may be reasonably necessary to result in an
Achievement of the Milestone pursuant to
Section 1.8(c)(ii), without the prior written consent of
EPIX, Predix shall not, and shall not permit any of its
subsidiaries to, do any of the following:
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(a) amend or otherwise change its Certificate of
Incorporation or Bylaws, or otherwise alter its corporate
structure through merger, liquidation, reorganization or
otherwise; |
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(b) sell, pledge, dispose of or encumber any assets (except
for (i) sales of assets in the ordinary course of business
and (ii) dispositions of obsolete or worthless assets); |
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(c) issue, sell, pledge, dispose of or encumber, or
authorize the issuance, sale, pledge, disposition or encumbrance
of, any shares of capital stock of any class, or any options,
warrants, convertible securities or other rights of any kind to
acquire any shares of capital stock, or any other ownership
interest (including, without limitation, any phantom interest)
(except for (i) the issuance of options or shares of Predix
Common Stock issuable pursuant to employee stock options under
the Predix Stock Plans or the Predix Warrants, as the case may
be, which in the case of Predix Warrants are outstanding on the
date hereof and (ii) actions taken by Predix or its
subsidiaries in furtherance of the Merger or the other
transactions contemplated hereby, as to which actions Predix or
its subsidiaries shall first consult with and obtain written
approval from EPIX); |
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(d) accelerate, amend or change the period of
exercisability of options granted under the Predix Stock Plans
or the Predix Warrants, as the case may be, or authorize cash
payments in exchange for (i) any options granted under the
Predix Stock Plans or (ii) the Predix Warrants, except as
contemplated by this Agreement; |
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(e) (i) declare, set aside, make or pay any dividend
or other distribution (whether in cash, stock or property or any
combination thereof) in respect of any of its capital stock,
except that a wholly-owned subsidiary may declare and pay a
dividend to its parent, (ii) split, combine or reclassify
any of its capital stock or issue or authorize or propose the
issuance of any other securities in respect of, in lieu of or in
substitution for shares of its capital stock or (iii) amend
the terms of, repurchase, redeem or otherwise acquire, or permit
any subsidiary to repurchase, redeem or otherwise acquire, any
of its securities, or propose to do any of the foregoing (except
for (A) the repurchase of shares of restricted stock under,
and in accordance with the terms of, the applicable restricted
stock agreements, if Predix or its subsidiaries have notified
EPIX in writing at least five (5) business days prior to
any such repurchase and included in such notification is a
description of the circumstances giving rise to, and permitting,
such repurchase and (B) transactions in furtherance of the
Merger or the other transactions contemplated hereby, as to
which actions Predix or its subsidiaries shall first consult
with and obtain written approval from EPIX); |
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(f) sell, transfer, license, sublicense or otherwise
dispose of any Predix IP Rights, or amend or modify any existing
agreements with respect to any Predix IP Rights; |
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(g) (i) acquire (by merger, consolidation, or
acquisition of stock or assets or otherwise) any corporation,
partnership or other business organization or division thereof;
(ii) incur any indebtedness for borrowed money or issue any
debt securities or assume, guarantee or endorse or otherwise as
an accommodation become responsible for, the obligations of any
person, or make any loans or advances in excess of $100,000
except in the ordinary course of business consistent with past
practice; (iii) enter into or amend any material contract
or agreement and any Predix Contract other than in the ordinary
course of business; (iv) authorize any capital expenditures
or purchase of fixed assets which are, in the aggregate, in
excess of $100,000, taken as a whole (except pursuant to a
capital expenditure budget approved in writing by both parties);
or (v) enter into or amend any contract, agreement,
commitment or arrangement and any Predix Contract to effect any
of the matters prohibited by this Section 4.1(g); |
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(h) increase the compensation payable or to become payable
to its officers, employees or consultants, except for increases
in salary or wages of employees who are not officers in
accordance with past practices, or grant any severance or
termination pay to, or enter into any employment or severance
agreement with, any director, officer (except for officers who
are terminated on an involuntary basis) or other employee, or
establish, adopt, enter into or amend any employee benefit plan,
provided, that Predix and its subsidiaries may provide
their officers and employees retention bonuses to retain such
officers or employees services through the Effective
Time, valued at not more than twenty percent (20%) of such
officers or employees yearly base salary as of the
date hereof, payable in cash, stock or an option to purchase
stock that becomes payable or vests on or after the Effective
Time, if Predix or its subsidiaries have notified EPIX in
writing at least five (5) business days prior to granting
any such retention bonus and included in such notification is a
description of |
A-37
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the circumstances giving rise to such retention bonus,
provided, further, that the aggregate value of all
retention bonuses granted by Predix shall not exceed $350,000; |
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(i) take any action, other than as required by GAAP, to
change accounting policies or procedures; |
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(j) make any material tax election inconsistent with past
practices or settle or compromise any material federal, state,
local or foreign tax liability or agree to an extension of a
statute of limitations for any assessment of any tax; |
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(k) pay, discharge or satisfy any claims, liabilities or
obligations (absolute, accrued, asserted or unasserted,
contingent or otherwise), other than the payment, discharge or
satisfaction in the ordinary course of business and consistent
with past practice of liabilities reflected or reserved against
in its financial statements, or incurred in the ordinary course
of business and consistent with past practice; |
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(l) enter into any material partnership arrangements, joint
development agreements, strategic alliances or collaborations; |
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(m) except as may be required by law, take any action to
terminate or amend any of the Predix Employee Plans other than
in connection with the Merger; or |
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(n) take, or agree in writing or otherwise to take, any of
the actions described in Sections 4.1(a) through
(m) above, or any action which would make any of the
representations or warranties of Predix contained in this
Agreement untrue or incorrect or prevent Predix from performing
or cause Predix not to perform its covenants hereunder or result
in any of the conditions to the Merger set forth herein not
being satisfied. |
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If Predix or its subsidiaries wish to obtain the consent of EPIX
to take actions for which prior consent is required pursuant to
this Section 4.1, Predix shall request such consent in
writing by telecopy to the attention of the Chief Executive
Officer of EPIX. A consent signed by either such officer shall
be deemed sufficient for purposes hereof. In addition, if EPIX
receives such a request but does not respond in writing (which
may include an e-mailed
response) to such request within five (5) business days
after the date the request is telecopied, EPIX shall be deemed
to have consented to the requested action for all purposes of
this Agreement. |
4.2. MUTUAL NON-SOLICITATION
(a) Without the prior written consent of the other party,
neither Predix and its subsidiaries nor EPIX shall directly or
indirectly through any officer, director, employee,
representative or agent, solicit, encourage, have negotiations
with respect to (including by way of furnishing information) or
take any action that could reasonably be expected to result in
the initiation or submission of any inquiries, proposals or
offers regarding, or approve, endorse or recommend, any
acquisition, merger, take-over bid, sale of substantial assets,
sale of shares of capital stock (including without limitation by
way of a tender offer) or similar transactions (any of the
foregoing inquiries or proposals being referred to herein as an
Acquisition Proposal); provided,
however, that (A) prior to the adoption and approval
of this Agreement by the stockholders of EPIX, EPIX may furnish
nonpublic information regarding EPIX to any third party in
response to an EPIX Superior Offer (as defined below) that is
submitted to EPIX by such third party (and not withdrawn) if:
(i) EPIX shall not have breached this Section 4.2;
(ii) the EPIX Board of Directors reasonably concludes in
good faith, after having received the advice of its outside
legal counsel, that not taking such actions would be
inconsistent with the Board of Directors fiduciary duties
under applicable law; (iii) EPIX complies with the
provisions of this Section 4.2; and (iv) EPIX receives
from such third party an executed confidentiality agreement
containing provisions at least as favorable to EPIX as those
contained in the Confidentiality Agreement (as defined in
Section 5.3(b) hereof), and (B) prior to the adoption
and approval of this Agreement by the stockholders of Predix,
Predix may furnish nonpublic information regarding Predix to any
third party in response to a Predix Superior Offer (as defined
below) that is submitted to Predix by such third-party (and not
withdrawn) if: (i) Predix shall not have breached this
Section 4.2; (ii) the Predix Board of Directors
reasonably concludes in good faith, after
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having received the advice of its outside legal counsel, that
taking such actions is required in order for the Board of
Directors of Predix to comply with its fiduciary obligations to
Predixs stockholders under applicable law;
(iii) Predix complies with the provisions of this
Section 4.2; and (iv) Predix receives from such
third-party an executed confidentiality agreement containing
provisions at least as favorable to Predix as those contained in
the Confidentiality Agreement (as defined in Section 5.3(b)
hereof). EPIX Superior Offer shall mean an
unsolicited bona fide written offer by a third party to enter
into (i) a merger, consolidation, amalgamation, share
exchange, business combination, issuance of securities,
acquisition of securities, reorganization, recapitalization,
tender offer, exchange offer or other similar transaction or
(ii) a sale, lease, exchange transfer, license, acquisition
or disposition of any business or other disposition of at least
50% of the assets of the party in a single transaction or series
of related transactions that: (a) was not obtained or made
as a direct or indirect result of a breach of (or in violation
of) this Agreement; and (b) is on terms and conditions that
the board of directors of EPIX determines, in its reasonable,
good faith judgment, after obtaining and taking into account
such matters that its board of directors deems relevant
following consultation with its outside legal counsel and
financial advisor: (x) is more favorable, from a financial
point of view, to EPIXs stockholders than the terms of the
Merger; and (y) is reasonably capable of being consummated.
Predix Superior Offer shall mean an
unsolicited bona fide written offer by a third party to enter
into a merger, consolidation, amalgamation, share exchange,
business combination, issuance of securities, acquisition of
securities, reorganization, recapitalization, tender offer,
exchange offer, or sale, lease, exchange transfer, license,
acquisition or disposition of assets, or other similar
transaction that would, if consummated, result in the
acquisition of all, but not less than all, of the issued and
outstanding shares of Predix capital stock or all, or
substantially all, of the assets of Predix and its subsidiaries
on a consolidated basis, and that (a) was not obtained or
made as a direct or indirect result of a breach of (or in
violation of) this Agreement; and (b) is on terms and
conditions that the Board of Directors of Predix determines, in
its reasonable, good faith judgment, after obtaining and taking
into account such matters that its board of directors deems
relevant following consultation with its outside legal counsel
and financial advisor: (x) is more favorable, from a
financial point of view, to Predixs stockholders than the
terms of the Merger; (y) is not conditioned upon obtaining
additional financing or any regulatory approvals, or subject to
any additional conditions beyond those contemplated by this
Agreement; and (z) is reasonably capable of being
consummated.
(b) Both Predix (and its subsidiaries) and EPIX shall
immediately notify the other after receipt of any Acquisition
Proposal or any request for nonpublic information relating to it
or its subsidiaries in connection with an Acquisition Proposal
or for access to its properties, books or records by any person
or entity that informs its Board of Directors that it is
considering making, or has made, an Acquisition Proposal. Such
notice shall be made orally and in writing and shall indicate in
reasonable detail the identity of the offeror and the terms and
conditions of such proposal, inquiry or contact.
(c) Both Predix (and its subsidiaries) and EPIX shall
immediately cease and cause to be terminated any existing
discussions or negotiations with any other parties conducted
heretofore with respect to any acquisition, merger, take-over
bid, sale of substantial assets, sale of shares of capital stock
(including without limitation by way of a tender offer) or
similar transactions. Predix and EPIX agree not (and Predix
shall not permit its subsidiaries), to release any third party
from any confidentiality or standstill agreement to which it (or
its subsidiaries) is a party.
(d) Notwithstanding anything to the contrary contained in
this Agreement, (i) the obligation of EPIX to call, give
notice of, convene and hold the EPIX Stockholders Meeting
shall not be limited or otherwise affected by the commencement,
disclosure, announcement or submission to EPIX of any EPIX
Superior Offer with respect to it, and (ii) the obligation
of Predix to call, give notice of, convene and hold the Predix
Stockholders Meeting shall not be limited or otherwise
affected by the commencement, disclosure, announcement or
submission to Predix of any Predix Superior Offer with respect
to it.
(e) Both Predix (and its subsidiaries) and EPIX shall
ensure that the officers, directors and employees and any
investment banker or other retained advisor or representative
are aware of the restrictions described in this Section, and
shall be responsible for any breach of this Section 4.2 by
such officers, directors, employees, bankers, advisors and
representatives.
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4.3. CONDUCT OF BUSINESS BY
EPIX. EPIX covenants and agrees that between the date hereof
and the earlier of a termination of this Agreement in accordance
with its terms or the Effective Time, EPIX shall not conduct its
business other than in the ordinary course and consistent with
past practice. Without limiting the generality of the foregoing,
EPIX shall (i) continue its research and development,
clinical investigation and activities relating to the EPIX IP
Rights in accordance with past practice; (ii) use its
commercially reasonable efforts to (A) preserve intact its
business organization, (B) keep available to Predix the
services of its officers, employees and consultants,
(C) continue in full force and effect without material
modification all existing policies or binders of insurance
currently maintained in respect of EPIX and its business and
(D) preserve its current relationships with its clinical
investigators, suppliers, manufacturers and other persons with
which it has significant business relationships; and
(iii) not modify, amend, renew or replace, without
providing prior notice to Predix and receiving Predixs
prior written approval, any agreements set forth in
Section 4.3 of the EPIX Disclosure Schedule. In addition,
except as provided in Section 4.3 of the EPIX Disclosure
Schedule, without the prior written consent of Predix, EPIX
shall not do any of the following:
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(a) amend or otherwise change its Certificate of
Incorporation or By-Laws, or otherwise alter its corporate
structure through merger, liquidation, reorganization or
otherwise (other than the appointment of up to two
(2) additional members of the Board of Directors); |
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(b) sell, pledge, dispose of or encumber any assets (except
for (i) sales of assets in the ordinary course of business
and (ii) dispositions of obsolete or worthless assets); |
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(c) issue, sell, pledge, dispose of or encumber, or
authorize the issuance, sale, pledge, disposition or encumbrance
of, any shares of capital stock of any class, or any options,
warrants, convertible securities or other rights of any kind to
acquire any shares of capital stock, or any other ownership
interest (including, without limitation, any phantom interest)
(except for (i) the issuance of shares of EPIX Common Stock
issuable pursuant to the exercise of employee stock options
outstanding on the date of this Agreement under the EPIX Stock
Plans or pursuant to purchase rights under the EPIX ESPP, and
(ii) actions taken by EPIX in furtherance of the Merger or
the other transactions contemplated hereby, as to which actions
EPIX shall first consult with and obtain written approval from
Predix); |
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(d) accelerate, amend or change the period of
exercisability of options granted under the EPIX Stock Plans or
authorize cash payments in exchange for any options granted
under the EPIX Stock Plans except as contemplated by this
Agreement; |
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(e) (i) declare, set aside, make or pay any dividend
or other distribution (whether in case, stock or property or any
combination thereof) in respect of any of its capital stock,
(ii) split, combine or reclassify any of its capital stock
or issue or authorize or propose the issuance of any other
securities in respect of, in lieu of or in substitution for
shares of its capital stock or (iii) amend the terms of,
repurchase, redeem or otherwise acquire, any of its securities,
or propose to do any of the foregoing (except for (A) the
repurchase of shares of restricted stock under, and in
accordance with the terms of, the applicable restricted stock
agreements, if EPIX has notified Predix in writing at least five
(5) business days prior to any such repurchase and included
in such notification is a description of the circumstances
giving rise to, and permitting, such repurchase and
(B) transactions in furtherance of the Merger or the other
transactions contemplated hereby, as to which actions EPIX shall
first consult with and obtain written approval from Predix); |
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(f) sell, transfer, license, sublicense or otherwise
dispose of any EPIX IP Rights, or amend or modify any existing
agreements with respect to any EPIX IP Rights; |
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(g) (i) acquire (by merger, consolidation, or
acquisition of stock or assets or otherwise) any corporation,
partnership or other business organization or division thereof;
(ii) incur any indebtedness for borrowed money or issue any
debt securities or assume, guarantee or endorse or otherwise as
an accommodation become responsible for, the obligations of any
person, or make any loans or advances in excess of $100,000
except in the ordinary course of business consistent with past
practice; |
A-40
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(iii) enter into or amend any material contract or
agreement other than in the ordinary course of business;
(iv) authorize any capital expenditures or purchase of
fixed assets which are, in the aggregate, in excess of $100,000,
taken as a whole (except pursuant to a capital expenditure
budget approved in writing by both parties); or (v) enter
into or amend any contract, agreement, commitment or arrangement
to effect any of the matters prohibited by this
Section 4.3(g); |
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(h) increase the compensation payable or to become payable
to its officers, employees or consultants, except for increases
in salary or wages of employees who are not officers in
accordance with past practices, or grant any severance or
termination pay to, or enter into any employment or severance
agreement with, any director, officer (except for officers who
are terminated on an involuntary basis) or other employee, or
establish, adopt, enter into or amend any employee benefit plan,
provided, that EPIX may provide its officers and
employees retention bonuses to retain such officers or
employees services through the Effective Time, valued at
not more than twenty percent (20%) of such officers or
employees yearly base salary as of the date hereof,
payable in cash, stock or an option to purchase stock that
becomes payable or vests on or after the Effective Time, if EPIX
has notified Predix in writing at least five (5) business
days prior to granting any such retention bonus,
provided, further, that the aggregate value of all
retention bonuses granted by EPIX shall not exceed $350,000; |
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(i) take any action, other than as required by GAAP, to
change accounting policies or procedures; |
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(j) make any material tax election inconsistent with past
practices or settle or compromise any material federal, state,
local or foreign tax liability or agree to an extension of a
statute of limitations for any assessment of any tax; |
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(k) pay, discharge or satisfy any claims, liabilities or
obligations (absolute, accrued, asserted or unasserted,
contingent or otherwise), other than the payment, discharge or
satisfaction in the ordinary course of business and consistent
with past practice of liabilities reflected or reserved against
in its financial statements, or incurred in the ordinary course
of business and consistent with past practice; |
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(l) enter into any material partnership arrangements, joint
development agreements, strategic alliances or collaborations; |
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(m) except as may be required by law, take any action to
terminate or amend any of EPIXs employee benefit plans (as
defined in Section 3(3) of ERISA) other than in connection
with the Merger; or |
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(n) take, or agree in writing or otherwise to take, any of
the actions described in Sections 4.3(a) through (m), or
any action which would make any of the representations or
warranties of EPIX contained in this Agreement untrue or
incorrect or prevent EPIX from performing or cause EPIX not to
perform its covenants hereunder or result in any of the
conditions to the Merger set forth herein not being satisfied. |
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If EPIX wishes to obtain the consent of Predix to take actions
for which prior consent is required pursuant to this
Section 4.3, it shall request such consent in writing by
telecopy to the attention of the Chief Executive Officer and the
Chief Financial Officer of Predix. A consent signed by such
officer shall be deemed sufficient for purposes hereof. In
addition, if Predix receives such a request but does not respond
in writing (which may include an
e-mailed response) to
such request within five (5) business days after the date
the request is telecopied, Predix shall be deemed to have
consented to the requested action for all purposes of this
Agreement. |
A-41
ARTICLE V
ADDITIONAL AGREEMENTS
5.1. JOINT PROXY STATEMENT/
PROSPECTUS; REGISTRATION STATEMENT; OTHER. As promptly as
practicable after the execution of this Agreement, EPIX and
Predix will cooperate to prepare and file the Joint Proxy
Statement with the SEC, and EPIX will prepare and file with the
SEC the Registration Statement in which the Joint Proxy
Statement will be included as a prospectus. Each of EPIX and
Predix will respond to any comments of the SEC and will use its
commercially reasonable efforts to cause the Registration
Statement to be declared effective under the Securities Act as
promptly as practicable after such filing and will cause the
Joint Proxy Statement to be mailed to its stockholders at the
earliest practicable time. As promptly as practicable after the
execution of this Agreement, EPIX and Predix will prepare and
file any other filings required under the Exchange Act, the
Securities Act or any other federal or state securities laws
relating to the Merger and the transactions contemplated by this
Agreement, (collectively, the Other Filings).
Predix will cooperate with all reasonable requests of EPIX in
connection with the preparation, filing and response to comments
on the Registration Statement, Joint Proxy Statement and Other
Filings. Each party will notify the other party promptly upon
the receipt of any comments from the SEC or its staff and of any
request by the SEC or its staff or any other governmental
officials for amendments or supplements to the Registration
Statement, the Joint Proxy Statement or any Other Filing or for
additional information and will supply the other party with
copies of all correspondence between such party or any of its
representatives, on the one hand, and the SEC, or its staff or
other government officials, on the other hand, with respect to
the Registration Statement, the Joint Proxy Statement, the
Merger or any Other Filing. The Joint Proxy Statement, the
Registration Statement and the Other Filings will comply in all
material respects with all applicable requirements of law and
the rules and regulations promulgated thereunder. Whenever any
event occurs which is required to be set forth in an amendment
or supplement to the Joint Proxy Statement, the Registration
Statement or any Other Filing, EPIX or Predix, as the case may
be, will promptly inform the other party of such occurrence and
cooperate in filing with the SEC or its staff or any other
government officials, and/or mailing to stockholders of EPIX and
Predix, such amendment or supplement. The Joint Proxy Statement
will also include the recommendations of (i) the Board of
Directors of EPIX in favor of approval of this Agreement, the
Merger and the issuance of shares of EPIX Common Stock in the
Merger (except that the Board of Directors of EPIX may withdraw,
modify or refrain from making such recommendation if the EPIX
Board of Directors reasonably concludes in good faith, after
having received the advice of its outside legal counsel, that
not taking such actions would be inconsistent with the Board of
Directors fiduciary duties under applicable law) and
(ii) the Board of Directors of Predix in favor of approval
of this Agreement and the Merger, provided, however, that the
Board of Directors of Predix may withdraw, modify or refrain
from making such recommendation only if: (1) Predix has
received an unsolicited bona fide written Predix Superior Offer,
(2) Predix has notified EPIX, at least seven (7) days
in advance of the date upon which it intends to withdraw or
effect a change in its recommendation to Predixs
stockholders specifying the material terms and conditions of
such Predix Superior Offer and furnishing to EPIX complete and
unredacted copies of any relevant proposed transaction term
sheets, letters of intent or agreements with the party making
such Predix Superior Offer and any other material documents
received by it or its representatives, (3) Predix, prior to
effecting such a withdrawal or change in recommendation, has
negotiated, and has caused its financial and legal advisors to
negotiate with EPIX i n good faith for ten (10) days to
make such adjustments in the terms and conditions of this
Agreement such that such Predix Superior Offer would no longer
constitute a Predix Superior Offer, (4) Predixs Board
of Directors has considered such adjustments in the terms and
conditions of this Agreement resulting from such negotiations,
and has concluded in good faith, based upon consultation with
its financial advisors and with Predixs outside legal
counsel, that such proposal for a Predix Superior Offer remains
a Predix Superior Offer even after giving effect to the
adjustments proposed during such negotiations with EPIX, and
(5) the Predix Board of Directors reasonably concludes in
good faith, after having received the advice of its outside
legal counsel, that taking such actions is required in order for
the Board of Directors of Predix to comply with its fiduciary
obligations to Predixs stockholders under applicable law.
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5.2. MEETINGS OF
STOCKHOLDERS. Promptly after the date hereof, Predix will
take all action necessary in accordance with Delaware Law and
its Certificate of Incorporation and Bylaws to convene the
Predix Stockholders Meeting to consider the approval of
this Agreement and the Merger as promptly as practicable, and in
any event within twenty (20) days after the declaration of
effectiveness of the Registration Statement, for the purpose of
voting upon this Agreement and the Merger. Promptly after the
date hereof, EPIX will take all action necessary in accordance
with Delaware Law and its Certificate of Incorporation and
Bylaws to convene the EPIX Stockholders Meeting to be held
as promptly as practicable, and in any event within twenty
(20) days after the declaration of effectiveness of the
Registration Statement, for the purpose of (i) voting upon
this Agreement and the Merger and (ii) the issuance of
shares of EPIX Common Stock by virtue of the Merger. EPIX and
Predix will each use its commercially reasonable efforts to
solicit from its stockholders proxies in favor of the approval
of the foregoing proposals and to take all other action
necessary or advisable to secure the vote or consent of their
respective stockholders required by the rules of the SEC, the
National Association of Securities Dealers, Inc. or Delaware
Law, as applicable, to obtain such approvals, except,
(i) in the case of EPIX, if the Board of Directors of EPIX
reasonably concludes in good faith, after having received the
advice of its outside legal counsel, that taking such actions
would be inconsistent with the Board of Directors
fiduciary duties under applicable law, and (ii) in the case
of Predix, Predix has taken the actions set forth in the last
sentence of Section 5.1. EPIX may also include proposals
for the ratification of its independent auditors and election of
directors for approval at the EPIX stockholder meeting, and
other matters as may be mutually agreed upon by EPIX and Predix.
5.3. ACCESS TO INFORMATION;
CONFIDENTIALITY.
(a) Upon reasonable notice and subject to restrictions
contained in confidentiality agreements to which such party is
subject, Predix and EPIX shall each afford to the officers,
employees, accountants, counsel and other representatives of the
other, reasonable access, during the period prior to the
Effective Time, to all its and its subsidiaries
properties, books, contracts, commitments and records and,
during such period, Predix and EPIX each shall furnish promptly
to the other all information concerning its and its
subsidiaries business, properties and personnel as such
other party may reasonably request, and each shall make
available to the other the appropriate individuals (including
attorneys, accountants and other professionals) for discussion
of the others business, properties and personnel as either
party may reasonably request.
(b) Each party shall keep such information confidential in
accordance with the terms of the confidentiality agreement dated
October 28, 2005 (the Confidentiality
Agreement) between EPIX and Predix. This
Section 5.3(b) shall survive the termination of this
Agreement.
5.4. CONSENTS; APPROVALS.
Merger Sub, Predix and its subsidiaries and EPIX shall each use
their commercially reasonable efforts to obtain all consents,
waivers, approvals, authorizations or orders (including, without
limitation, all United States and foreign governmental and
regulatory rulings and approvals), and each party shall make all
filings (including, without limitation, all filings with
United States and foreign governmental or regulatory
agencies) required in connection with the authorization,
execution and delivery of this Agreement by each respective
party and the consummation by them of the transactions
contemplated hereby. Predix and EPIX shall furnish all
information required to be included in the Joint Proxy Statement
and the Registration Statement, or for any application or other
filing to be made pursuant to the rules and regulations of any
United States, or foreign governmental body in connection with
the transactions contemplated by this Agreement. As soon as
practicable following the date hereof, EPIX and Predix and its
subsidiaries will each use its commercially reasonable efforts
to obtain all material consents, waivers and approvals under any
of its or its subsidiaries agreements, contracts, licenses
or leases required to be obtained in connection with the
consummation of the Merger and the other transactions
contemplated herein. In addition, Merger Sub, Predix and its
subsidiaries and EPIX shall use commercially reasonable efforts
to file or otherwise submit, as soon as practicable after the
date of this Agreement, all applications, notices, reports and
other documents reasonably required to be filed by such party
with or otherwise submitted by such party to any Governmental
Authority with respect to the Merger and to submit promptly any
additional information requested by any such Governmental
Authority. Without limiting the generality of
A-43
the foregoing, Merger Sub, Predix and EPIX shall, promptly after
the date of this Agreement, prepare and file, if any,
(i) the notification and report any forms required to be
filed under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended (the HSR Act),
and (ii) as promptly as practicable thereafter respond in
compliance with any inquiries or requests received from the
Federal Trade Commission or the Department of Justice for
additional information or documentation and any inquiries or
requests received from any state attorney general, foreign
antitrust or competition authority or other Governmental
Authority in connection with antitrust or competition matters.
Each of EPIX and Predix will notify the other promptly upon
receipt of (i) any comments from any officials of any
Governmental Authority in connection with any filings made
pursuant hereto and (ii) any request by any officials of
any Governmental Authority for amendments or supplements to any
filings made pursuant to, or information provided to comply in
all material respects with, any legal requirements. Whenever any
event occurs that is required to be set forth in an amendment or
supplement to any filing made pursuant to this Section 5.4,
EPIX or Predix, as the case may be, will promptly inform the
other of such occurrence and cooperate in filing with the
applicable Governmental Authority such amendment of supplement.
EPIX and Predix agree that the costs and expenses incurred by
each party in connection with complying with this
Section 5.4 with respect to seeking and obtaining approval
of the transactions contemplated by this Agreement under the HSR
Act shall be borne by EPIX. For purposes of this Agreement,
Governmental Authority shall mean any
governmental or administrative agency, authority, department,
commission, instrumentality, board, bureau, court or arbitration
tribunal of the United States, any domestic state, locality or
any foreign country, and any political subdivision or agency
thereof, and includes any authority having governmental or
quasi-governmental powers, including any administrative agency
or commission, and any Self-Regulatory Organization, as defined
in Section 3(a)(26) of the Exchange Act.
5.5. STOCK OPTIONS AND
WARRANTS.
(a) At the Effective Time, Predixs obligations with
respect to each outstanding option to purchase shares of Predix
Common Stock (each, a Predix Option and
collectively, the Predix Options) under the
Predix Stock Plans, whether vested or unvested, will be assumed
by EPIX. Each Predix Option so assumed by EPIX under this
Agreement shall be subject to substantially the same terms and
conditions set forth in the Predix Stock Plans (which plans
shall be adopted upon substantially the same terms and
conditions by EPIX) or agreement pursuant to which such Predix
Option was issued as in effect immediately prior to the
Effective Time, except as follows (A) (i) such Predix
Option will be exercisable for that number of shares of EPIX
Common Stock equal to the product of the number of shares of
Predix Common Stock that were purchasable under such Predix
Option immediately prior to the Effective Time multiplied by the
Exchange Ratio, rounded down to the nearest whole number
of shares of EPIX Common Stock, and (ii) the per share
exercise price for the shares of EPIX Common Stock issuable upon
exercise of such assumed Predix Option will be equal to the
quotient determined by dividing the exercise price per share of
Predix Common Stock at which such Predix Option was exercisable
immediately prior to the Effective Time by the Exchange Ratio,
and rounding the resulting exercise price up to the nearest
whole cent and (B) each Predix Option shall entitle the
holder thereof at the Effective Time the right to receive in
cash such holders pro rata portion of the Milestone
Payment in accordance with Section 1.8. Following the
Effective Time, EPIX will send to the holders of the assumed
Predix Options a written notice setting forth (i) the
number of shares of EPIX Common Stock that are subject to such
assumed Predix Option, and (ii) the exercise price per
share of EPIX Common Stock issuable upon exercise of such
assumed Predix Option. In addition, EPIX shall file with the
SEC, no later than ninety (90) days after the Effective
Time, a registration statement on
Form S-8
registering the exercise of any Predix Options issued under the
Predix Stock Plans assumed by EPIX pursuant to this
Section 5.5 (to the extent the exercise of such options is
eligible to be registered using a
Form S-8
registration statement).
(b) EPIX and Predix shall take all action that may be
reasonably necessary to effectuate the provisions of this
Section 5.5. The Predix Options assumed by EPIX shall
retain their existing vesting schedules following the Effective
Time.
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(c) It is the intention of the parties that Predix Options
assumed by EPIX qualify following the Effective Time as
incentive stock options as defined in the Code
(ISOs) to the extent such Predix
Options qualified as ISOs prior to the Effective Time.
(d) At the Effective Time, Predixs obligations with
respect to each Predix Warrant will be assumed by EPIX. Each
Predix Warrant so assumed by EPIX under this Agreement shall be
subject to substantially the same terms and conditions set forth
in the warrant or agreement pursuant to which such Predix
Warrant was issued as in effect immediately prior to the
Effective Time, except as follows (A) (i) such Predix
Warrant will be exercisable for that number of shares of EPIX
Common Stock equal to the product of the number of shares of
Predix Common Stock that were purchasable under such Predix
Warrant immediately prior to the Effective Time, or in the case
of a Predix Warrant exercisable for Predix Preferred Stock that
number of shares of Predix Common Stock the Predix Preferred
Stock issuable upon exercise of such Predix Warrant was
convertible into immediately prior to the Effective Time,
multiplied by the Exchange Ratio, rounded down to the nearest
whole number of shares of EPIX Common Stock, and (ii) the
per share exercise price for the shares of EPIX Common Stock
issuable upon exercise of such PURCHASE Warrant will be equal to
the quotient determined by dividing the exercise price per share
of Predix Common Stock or Predix Preferred Stock, as the case
may be, at which such Predix Warrant was exercisable immediately
prior to the Effective Time by the Exchange Ratio, and rounding
the resulting exercise price up to the nearest whole cent and
(B) each Predix Warrant shall entitle the holder thereof at
the Effective Time the right to receive in cash such
holders pro rata portion of the Milestone Payment in
accordance with Section 1.8.
(e) EPIX will reserve sufficient shares of EPIX Common
Stock for issuance under this Section 5.5.
5.6. PREDIX AFFILIATE
AGREEMENTS. Set forth in Section 5.6 of the Predix
Disclosure Schedule is a list of those persons who may be deemed
to be, in Predixs reasonable judgment, affiliates of
Predix within the meaning of Rule 145 promulgated under the
Securities Act (a Predix Affiliate). Predix
will provide EPIX with such information and documents as EPIX
reasonably requests for purposes of reviewing such list. Predix
will use its commercially reasonable efforts to deliver or cause
to be delivered to EPIX prior to the Effective Time from each
Predix Affiliate an executed affiliate agreement in
substantially the form of Exhibit C hereto (the
Predix Affiliate Agreement), each of which
will be in full force and effect as of the Effective Time. EPIX
will be entitled to place appropriate legends on the certificate
evidencing any EPIX Common Stock to be received by a Predix
Affiliate pursuant to the terms of this Agreement, and to issue
appropriate stop transfer instructions to the transfer agent for
the EPIX Common Stock, consistent with the terms of the Predix
Affiliate Agreement.
5.7. LOCKUP AGREEMENTS. Each
member of Predixs management, each of Predixs
directors, the Chairman of the Board of Directors of EPIX and
each Predix stockholder set forth on Schedule 5
hereto shall execute a lockup agreement, in substantially the
form of Exhibit D hereto (the Lockup
Agreement), each of which will be in full force and
effect as of the Effective Time. EPIX will be entitled to place
appropriate legends on the certificate evidencing any EPIX
Common Stock to be received by the persons and entities set
forth on Schedule 5 hereto and to issue appropriate
stop-transfer instructions to the transfer agent for the EPIX
Common Stock, consistent with the terms of the Lockup Agreement.
5.8. INDEMNIFICATION AND
INSURANCE.
(a) From and after the Effective Time, the Surviving
Corporation will fulfill and honor in all respects the
obligations of Predix which exist prior to the date hereof to
indemnify Predixs present and former directors, officers,
employees and their heirs, executors and assigns. The
Certificate of Incorporation and Bylaws of the Surviving
Corporation will contain provisions with respect to
indemnification and elimination of liability for monetary
damages set forth in Predixs Certificate of Incorporation
and Bylaws on the date hereof, which provisions will not be
amended, repealed or otherwise modified for a period of six
(6) years from the Effective Time in any manner that would
adversely affect the rights thereunder of individuals who, at
the Effective Time, were directors, officers, employees or
agents of Predix, unless such modification is required by law
and then only to the minimum extent required by such law.
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(b) After the Effective Time the Surviving Corporation
will, to the fullest extent permitted under applicable law or
under the Surviving Corporations Certificate of
Incorporation or Bylaws, indemnify and hold harmless, each
present and former director, officer or employee of Predix and
his or her heirs, executors and assigns (collectively, the
Indemnified Parties) against any costs or
expenses (including attorneys fees), judgments, fines,
losses, claims, damages, liabilities and amounts paid in
settlement in connection with any claim, action, suit,
proceeding or investigation, whether civil, criminal,
administrative or investigative, arising out of or pertaining to
the transactions contemplated by this Agreement or otherwise
pertaining to any action or omission in his or her capacity as a
director, officer, employee or agent of Predix occurring prior
to the Effective Time to the same extent as provided in
Predixs Certificate of Incorporation and Bylaws or any
applicable contract or agreement as in effect on the date hereof
and disclosed on Section 5.8(b) of the Predix Disclosure
Schedule, in each case for a period of six (6) years after
the Effective Time. In the event of any such claim, action,
suit, proceeding or investigation (whether arising before or
after the Effective Time) and subject to the specific terms of
any indemnification contract, (i) any counsel retained by
the Indemnified Parties for any period after the Effective Time
will be reasonably satisfactory to the Surviving Corporation,
(ii) after the Effective Time, the Surviving Corporation
will pay the reasonable fees and expenses of such counsel,
promptly after statements therefor are received and
(iii) the Surviving Corporation will cooperate in the
defense of any such matter; provided, however,
that the Surviving Corporation will not be liable for any
settlement effected without its prior written consent (which
consent will not be unreasonably withheld); and provided,
further, that, in the event that any claim or claims for
indemnification are asserted or made within such six-year
period, all rights to indemnification in respect of any such
claim or claims will continue until the disposition of any and
all such claims. The Indemnified Parties as a group may retain
only one law firm to represent them in each applicable
jurisdiction with respect to any single action unless there is,
under applicable standards of professional conduct, a conflict
on any significant issue between the positions of any two or
more Indemnified Parties, in which case each Indemnified Party
which respect to whom such a conflict exists (or group of such
Indemnified Parties who among them have no such conflict) may
retain one separate law firm in each applicable jurisdiction.
(c) Predix shall use commercially reasonable efforts, after
consultation with EPIX, to negotiate and secure a
tail on its existing Directors, Officers and Company
Liability insurance policies for a period of six (6) years,
at a total cost not to exceed $25,000 per year of coverage,
which cost shall be paid by EPIX.
(d) From and after the Effective Time, EPIX shall
unconditionally guarantee the timely payment of all funds owing
by, and the timely performance of all other obligations of, the
Surviving Corporation under this Section 5.8 if requested
to do so by the Surviving Corporation and if legally permitted
to do so.
(e) This Section 5.8 will survive any termination of
this Agreement and the consummation of the Merger at the
Effective Time, is intended to benefit Predix, the Surviving
Corporation and the Indemnified Parties, and will be binding on
all successors and assigns of the Surviving Corporation and
shall be enforceable by the Indemnified Parties.
(f) Nothing contained in this Section 5.8 is intended
to limit in any manner and at any time rights that any
Indemnified Party may have under and in accordance with all
provisions of Predixs Certificate of Incorporation and
Bylaws, which rights shall survive the Effective Time and shall
be binding on the Surviving Corporation and all successors and
assigns of the Surviving Corporation, in accordance with their
respective terms.
5.9. NOTIFICATION OF CERTAIN
MATTERS.
(a) Predix shall give prompt notice to EPIX, and EPIX shall
give prompt notice to Predix, of (i) the occurrence, or
non-occurrence, of any event the occurrence or non-occurrence of
which would be likely to cause any representation or warranty
contained in this Agreement to be materially untrue or
inaccurate, and (ii) any failure of Predix or EPIX, as the
case may be, materially to comply with or satisfy any covenant,
condition or agreement to be complied with or satisfied by it
hereunder; provided, however, that the delivery of
any notice pursuant to this Section shall not limit or otherwise
affect the remedies available hereunder to the party receiving
such notice; and provided, further, that failure
to give such notice shall
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not be treated as a breach of covenant for the purposes of
Sections 6.2(a) and (b) and 6.3(a) and (b) unless
the failure to give such notice results in material prejudice to
the other party.
(b) Each of Predix and EPIX shall give prompt notice to the
other of: (i) any notice or other communication from any
person alleging that the consent of such person is or may be
required in connection with the Merger or other transactions
contemplated by this Agreement; (ii) any notice or other
communication from any Governmental Authority in connection with
the Merger or other transactions contemplated by this Agreement;
(iii) any litigation relating to or involving or otherwise
affecting Predix, its subsidiaries or EPIX that relates to the
Merger or other transactions contemplated by this Agreement;
(iv) the occurrence of a default or event that, with notice
or lapse of time or both, is reasonably likely to become a
default under a Predix Contract; and (v) any change that
would be considered reasonably likely to result in a Material
Adverse Effect, or is likely to impair in any material respect
the ability of either Predix or EPIX to consummate the
transactions contemplated by this Agreement.
5.10. FURTHER ACTION. Upon
the terms and subject to the conditions hereof, each of the
parties hereto in good faith shall use all commercially
reasonable efforts to take, or cause to be taken, all actions
and to do, or cause to be done, all other things necessary,
proper or advisable to consummate and make effective as promptly
as practicable the transactions contemplated by this Agreement,
to obtain in a timely manner all necessary waivers, consents and
approvals and to effect all necessary registrations and filings,
and to otherwise satisfy or cause to be satisfied all conditions
precedent to its obligations under this Agreement.
5.11. PUBLIC ANNOUNCEMENTS.
EPIX and Predix shall consult with each other before issuing any
press release or otherwise making any public statements with
respect to the Merger or this Agreement and shall not issue any
such press release or make any such public statement without the
prior consent of the other parties, which shall not be
unreasonably withheld or delayed; provided,
however, that, on the advice of legal counsel, EPIX may
comply with any SEC requirements under the Securities Act or
Exchange Act which requires any public disclosure, without the
consent of Predix.
5.12. LISTING OF EPIX COMMON
STOCK. EPIX shall use its reasonable best efforts to cause
the shares of EPIX Common Stock to be issued in the Merger to be
approved for listing on the NASDAQ prior to the Effective Time.
5.13. CONVEYANCE TAXES. EPIX
and Predix shall cooperate in the preparation, execution and
filing of all returns, questionnaires, applications or other
documents regarding any real property transfer or gains, sales,
use, transfer, value added, stock transfer and stamp taxes, any
transfer, recording, registration and other fees, and any
similar taxes which become payable in connection with the
transactions contemplated hereby that are required or permitted
to be filed on or before the Effective Time. EPIX shall pay all
such taxes and fees.
5.14. TAX-FREE
REORGANIZATION. Notwithstanding anything herein to the
contrary, each of Merger Sub, EPIX and Predix shall use
reasonable best efforts to cause the Merger to qualify, and will
not take any actions, or fail to take any action, which could
reasonably be expected to prevent the Merger from qualifying as
a reorganization under the provisions of Section 368(a) of
the Code. Merger Sub shall, and shall cause the Surviving
Corporation and EPIX to, report, to the extent required by the
Code or the regulations thereunder, the Merger for United States
federal income tax purposes as a reorganization within the
meaning of Section of 368(a) of the Code. EPIX and Predix will
each make available to the other party and their respective
legal counsel copies of all returns requested by the other party.
5.15. BOARD OF DIRECTORS AND
OFFICERS OF EPIX. The Board of Directors of EPIX shall cause
EPIXs Board of Directors, immediately after the Effective
Time, to consist of no more than nine persons, and with respect
to such Board of Directors: (i) to appoint four Predix
nominees, which shall include Frederick Frank, Michael
Kauffman, M.D., Ph.D., Patrick J. Fortune, Ph.D.
and Ian F. Smith, (the Predix Nominees),
(ii) to appoint five EPIX nominees, which may include
EPIXs directors immediately prior to the Effective Time.
In addition, EPIX shall cause the Chief Executive Officer of
Predix immediately prior to the Effective Time to be the Chief
Executive Officer of EPIX immediately
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after the Effective Time pursuant to an employment agreement
upon mutually agreeable terms and conditions.
5.16. ACTIONS BY EPIX AND MERGER
SUB. From and after the Effective Time, all action necessary
in connection with the implementation of this Agreement on
behalf of EPIX and Merger Sub or the settlement of any dispute,
including, without limitation, with regard to matters pertaining
to the indemnification provisions of this Agreement and all
additional action as is contemplated to be taken by or on behalf
of the EPIX and Merger Sub by the terms of this Agreement,
including the determination of whether there is an Achievement
of the Milestone pursuant to Section 1.8(c) and whether to
make the Milestone Payment in cash, shares of EPIX Common Stock
or a combination thereof pursuant to Section 1.8(d), shall
be taken only with the approval or upon the direction of a
majority of the members of the Board of Directors of EPIX that
are not Predix Nominees or were not members of the Board of
Directors of Predix before the Effective Time.
5.17. EMPLOYEE BENEFITS;
SEVERANCE PAYMENTS. If at any time between the Effective
Time and the twelve (12) month anniversary of the Effective
Time, EPIX, the Surviving Corporation or their subsidiaries
causes a Continuing Employee (as defined in
Schedule 6 hereto) (other than those employees
specifically listed as ineligible individuals on
Schedule 6 hereto) to suffer an Adverse Event (as
defined in Schedule 6 hereto), such Continuing
Employee shall be entitled to the payments set forth on
Schedule 6 hereto from EPIX, the Surviving
Corporation or their subsidiaries, as the case may be.
5.18. RESALE REGISTRATION
STATEMENT.
(a) As soon as practicable and in any event within
90 days after the Effective Time, EPIX shall file with the
SEC, and thereafter use its commercially reasonable efforts to
have declared effective as soon as practicable, a registration
statement on
Form S-3 (or if
EPIX is not eligible to use
Form S-3, any
other form that EPIX is eligible to use) (a
S-3
Registration Statement) under the Securities Act
covering the resale by (i) the Chairman of the Board of
Directors of EPIX and (ii) former affiliates of Predix
(including any former affiliates of Predix who may following the
Effective Time be current affiliates of EPIX) listed on
Schedule 7 hereto (collectively, the
Affiliate Stockholders) of shares of EPIX
Common Stock issued pursuant to this Agreement as Merger
Consideration (the Registrable Merger
Shares). In its discretion, EPIX will be permitted to
register any other shares for resale by other eligible selling
stockholders using
the S-3
Registration Statement. EPIX shall use commercially reasonable
efforts to keep
the S-3
Registration Statement continuously effective and usable for the
resale of the Registrable Merger Shares covered thereby for a
period commencing on the date on which the SEC declares the
S-3 Registration
Statement effective and ending on the earlier of (i) the
date upon which all of the Registrable Merger Shares first
become eligible for resale pursuant to Rule 145 under the
Securities Act without restriction or (ii) the first date
upon which all of the Registrable Merger Shares covered by
the S-3
Registration Statement have been sold pursuant to such
registration statement.
(b) EPIX may, by written notice to the Affiliate
Stockholders, (i) delay the filing or effectiveness of
the S-3
Registration Statement for up to thirty (30) days, or for
such longer period, as a result of restraints or restrictions
under applicable law or (ii) suspend
the S-3
Registration Statement after effectiveness and require that the
Affiliate Stockholders immediately cease sales of shares
pursuant to
the S-3
Registration Statement (A) for a period of not more than
thirty (30) consecutive days or seventy-five (75) days
in the aggregate during any twelve (12) consecutive
calendar months, in the event that EPIX files a registration
statement (other than a registration statement on
Form S-8 or its
successor form) with the SEC for a then pending public offering
of its securities or (B) following the effectiveness of
the S-3
Registration Statement, for no longer than ten
(10) consecutive trading days if an event has occurred or
EPIX has entered into a transaction which EPIX determines in
good faith must be disclosed in order for EPIX to comply with
the public disclosure requirements imposed on EPIX under the
Securities Act in connection with
the S-3
Registration Statement, provided, that in respect of all
such events or occurrences EPIX shall not suspend the
effectiveness of
the S-3
Registration Statement for more than thirty (30) trading
days in the aggregate in any twelve (12) consecutive
calendar months.
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(c) If EPIX delays or suspends
the S-3
Registration Statement or requires the Affiliate Stockholders to
cease sales of shares pursuant to Section 5.18(b) above,
EPIX shall, as promptly as practicable (and in any event within
four (4) business days) following the termination of the
circumstance which entitled EPIX to do so, take such actions as
may be necessary to file or reinstate the effectiveness of the
S-3 Registration
Statement and/or give written notice to all Affiliate
Stockholders authorizing them to resume sales pursuant to
the S-3
Registration Statement. If as a result thereof the prospectus
included in
the S-3
Registration Statement has been amended to comply with the
requirements of the Securities Act, EPIX shall enclose such
revised prospectus with the notice to Affiliate Stockholders
given pursuant to this Section 5.18(c), and the Affiliate
Stockholders shall make no offers or sales of shares pursuant to
the
S-3 Registration
Statement other than by means of such revised prospectus.
5.19. ACCOUNTANTS
LETTERS. Each of EPIX and Predix shall use its reasonable
best efforts to cause to be delivered to the other party a
comfort letter of Ernst & Young LLP dated
within two (2) business days before the date on which the
Registration Statement shall become effective and addressed to
such other party, in form and substance reasonably satisfactory
to such other party.
ARTICLE VI
CONDITIONS TO THE MERGER
6.1. CONDITIONS TO OBLIGATION OF
EACH PARTY TO EFFECT THE MERGER. The respective obligations
of each party to effect the Merger shall be subject to the
satisfaction at or prior to the Effective Time of the following
conditions:
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(a) Effectiveness of the Registration
Statement. The Registration Statement shall have been
declared effective by the SEC under the Securities Act. No stop
order suspending the effectiveness of the Registration Statement
shall have been issued by the SEC and no proceedings for that
purpose and no similar proceeding in respect of the Joint Proxy
Statement shall have been initiated or, to the knowledge of EPIX
or Predix, threatened by the SEC; |
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(b) Governmental Approvals. All approvals of,
declarations or filings, with any Governmental Authority
necessary for the consummation of the Merger, if any, shall have
been obtained or made. The waiting period (and any extension
thereof) under the HSR Act relating to the transaction
contemplated hereby will have expired or terminated early, if
required; |
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(c) Stockholder Approval. This Agreement
shall have been adopted by the requisite vote under Delaware Law
of the stockholders of EPIX and Predix, respectively, and
EPIXs and Predixs Certificate of Incorporation and
Bylaws, respectively; and the issuance of shares of EPIX Common
Stock by virtue of the Merger shall have been approved by the
requisite vote under the rules of the SEC, the National
Association of Securities Dealers, Inc. or Delaware Law by the
stockholders of EPIX; |
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(d) No Injunctions or Restraints; Illegality.
No temporary restraining order, preliminary or permanent
injunction or other order (whether temporary, preliminary or
permanent) issued by any court of competent jurisdiction or
other legal restraint or prohibition (an
Injunction) preventing the consummation of
the Merger on substantially identical terms and conferring upon
the parties hereto substantially all the rights and benefits as
contemplated herein, shall be in effect, nor shall any
proceeding brought by any Governmental Authority seeking any of
the foregoing be pending; and there shall not be any action
taken, or any statute, rule, regulation or order enacted,
entered, enforced or deemed applicable to the Merger, which
makes the consummation of the Merger on substantially identical
terms and conferring upon the parties hereto substantially all
the rights and benefits as contemplated herein, illegal; |
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(e) Tax Opinions. EPIX shall have received
the written opinion of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C. and Predix shall have received the written
opinion of Goodwin Procter LLP, in form and substance reasonably
satisfactory to them to the effect that the Merger will
constitute a reorganization within the meaning of
Section 368 of the Code; and |
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(f) EPIX Notes. No Injunction, or final,
non-appealable judgment, decree or order issued by any court of
competent jurisdiction shall be in effect which Injunction,
judgment, decree or order would result in the acceleration of
payment of the amounts outstanding under that certain Indenture,
dated as of June 7, 2004, between EPIX and U.S. Bank
National Association, as trustee, or any notes issued thereunder. |
6.2. ADDITIONAL CONDITIONS TO
OBLIGATIONS OF EPIX. The obligations of EPIX to effect the
Merger are also subject to the following conditions:
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(a) Representations and Warranties. The
representations and warranties of Predix contained in this
Agreement (together with the Predix Disclosure Schedule) shall
be true and correct in all material respects on and as of the
Effective Time, with the same force and effect as if made on and
as of the Effective Time, except for (i) those
representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations
and warranties shall be true and correct in all respects and
(ii) those representations and warranties which address
matters only as of a particular date, in which case such
representations and warranties that are qualified by materiality
or Material Adverse Effect shall be true and correct in all
respects, and those not so qualified shall remain true and
correct as of such date; and EPIX shall have received a
certificate to such effect signed by the President and Chief
Executive Officer and Chief Financial Officer of Predix; |
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(b) Agreements and Covenants. Predix shall
have performed or complied with all agreements and covenants
required by this Agreement to be performed or complied with by
it on or prior to the Effective Time, and EPIX shall have
received a certificate to such effect signed by the President
and Chief Executive Officer and Chief Financial Officer of
Predix; |
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(c) Consents Obtained. EPIX shall have
received evidence, in form and substance satisfactory to it,
that the consents, waivers, approvals, authorizations or orders
required to be obtained, and all filings to be made, by Predix
shall have been obtained and made by Predix; |
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(d) Governmental Actions. There shall not
have been instituted, pending or threatened any action or
proceeding (or any investigation or other inquiry that might
result in such an action or proceeding) by any Governmental
Authority, nor shall there be in effect any judgment, decree or
order of any Governmental Authority, in either case, seeking to
prohibit or limit EPIX from exercising all material rights and
privileges pertaining to its ownership of the Surviving
Corporation or the ownership or operation by EPIX or the
Surviving Corporation of all or a material portion of the
business or assets of EPIX or the Surviving Corporation, or
seeking to compel EPIX, the Surviving Corporation or any of
their subsidiaries to dispose of or hold separate all or any
material portion of the business or assets of EPIX or the
Surviving Corporation as a result of the Merger or the
transactions contemplated by this Agreement; |
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(e) Material Adverse Change. Since the date
of this Agreement, there shall have been no change, occurrence
or circumstance in the business, results of operations or
financial condition of Predix or any subsidiary of Predix having
or reasonably likely to have, individually or in the aggregate,
a Material Adverse Effect on Predix; |
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(f) Affiliate Agreements. EPIX shall have
received from each Predix Affiliate an Affiliate Agreement, and
such agreement shall be in full force and effect; |
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(g) Transfer of Material Agreements. Predix
shall have received all consents and approvals required to
consummate the Merger under Predixs and its
subsidiaries agreements listed on Schedule 8
hereto; |
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(h) Other Deliveries. EPIX shall have
received such other certificates and instruments (including
without limitation certificates of good standing of Predix and
each of its subsidiaries in its jurisdiction of organization and
the various foreign jurisdictions in which it is qualified,
certified charter documents, certificates as to the incumbency
of officers and the adoption of authorizing resolutions) as it
shall reasonably request in connection with the Closing; |
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(i) Voting Agreement. Stockholders of Predix
holding an aggregate of approximately forty percent (40%) of the
voting shares of Predix shall have entered into a Voting
Agreement, substantially in the form of Exhibit A
hereto, and such agreement shall be in full force and effect; |
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(j) Opinion of Predixs Counsel. EPIX
shall have received from Goodwin Procter LLP, counsel to Predix,
an opinion, substantially in the form of Exhibit E
hereto, addressed to EPIX dated as of the Effective Date; and |
6.3. ADDITIONAL CONDITIONS TO
OBLIGATIONS OF PREDIX. The obligation of Predix to effect
the Merger is also subject to the following conditions:
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(a) Representations and Warranties. The
representations and warranties of EPIX contained in this
Agreement (together with the EPIX Disclosure Schedule) shall be
true and correct in all material respects on and as of the
Effective Time, with the same force and effect as if made on and
as of the Effective Time, except for (i) those
representations and warranties that are qualified by materiality
or Material Adverse Effect, in which case such representations
and warranties shall be true and correct in all respects and
(ii) those representations and warranties which address
matters only as of a particular date, in which case such
representations and warranties that are qualified by materiality
or Material Adverse Effect shall be true and correct in all
respects, and those not so qualified shall remain true and
correct as of such date; and Predix shall have received a
certificate to such effect signed by the Chief Executive Officer
and Principal Accounting Officer of EPIX; |
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(b) Agreements and Covenants. EPIX shall have
performed or complied with all agreements and covenants required
by this Agreement to be performed or complied with by it on or
prior to the Effective Time, except to the extent any such
non-performance or non-compliance would not have a Material
Adverse Effect on EPIX, and Predix shall have received a
certificate to such effect signed by the Chief Executive Officer
and Principal Accounting Officer of EPIX; |
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(c) Consents Obtained. Predix shall have
received evidence, in form and substance satisfactory to it,
that all material consents, waivers, approvals, authorizations
or orders required to be obtained, and all filings required to
be made, by EPIX for the authorization, execution and delivery
of this Agreement and the consummation by them of the
transactions contemplated hereby shall have been obtained and
made by EPIX; |
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(d) Governmental Actions. There shall not
have been instituted, pending or threatened any action or
proceeding (or any investigation or other inquiry that might
result in such an action or proceeding) by any Governmental
Authority, nor shall there be in effect any judgment, decree or
order of any Governmental Authority, in either case, seeking to
prohibit or limit Predix from exercising all material rights and
privileges pertaining to its ownership of the Surviving
Corporation or the ownership or operation by Predix of all or a
material portion of the business or assets of Predix and its
subsidiaries, or seeking to compel Predix or its subsidiaries to
dispose of or hold separate all or any material portion of the
business or assets of Predix or its subsidiaries, as a result of
the Merger or the transactions contemplated by this Agreement; |
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(e) Material Adverse Change. Since the date
of this Agreement, there shall have been no change, occurrence
or circumstance in the business, results of operations or
financial condition of EPIX having or reasonably likely to have,
individually or in the aggregate, a Material Adverse Effect on
EPIX; |
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(f) Opinion of EPIXs Counsel. Predix
shall have received from Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., counsel to EPIX, an opinion, substantially in
the form of Exhibit F hereto, addressed to Predix
dated as of the Effective Date; |
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(g) NASDAQ Listing. The EPIX Common Stock
shall be listed on the NASDAQ National Market as of and from the
date of this Agreement through the Effective Time and the shares
of EPIX Common Stock issued in the Merge shall have been
approved for listing on the NASDAQ National Market as of the
Effective Time; |
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(h) Other Deliveries. Predix shall have
received such other certificates and instruments (including
without limitation certificates of good standing of EPIX in its
jurisdiction of organization and the various foreign
jurisdictions in which it is qualified, certified charter
documents, certificates as to the incumbency of officers and the
adoption of authorizing resolutions) as it shall reasonably
request in connection with the Closing; |
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(i) Closing Capital. EPIXs cash, cash
equivalents, restricted cash and securities available for sale
at the Effective Time less the aggregate amount of any and all
liabilities and obligations resulting from (i) severance or
similar obligations of EPIX as of the Effective Time;
(ii) fees payable to any financial advisor to EPIX;
(iii) fees owed or payable to EPIXs independent
public accountants; (iv) bonus payments to employees upon
consummation of the Merger; and (v) legal fees of EPIX in
connection with the negotiation and execution of this Agreement
and consummation of the Merger, shall be no less than the
$110,000,000; |
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(j) Board of Directors and Officers. EPIX
shall have taken all actions necessary so that the Board of
Directors of EPIX will be constituted as set forth in
Section 5.15 of this Agreement immediately after the
Effective Time. Each of the current officers of EPIX who is not
listed on Schedule 9 hereto shall have delivered to
EPIX their written resignations as officers of EPIX and each of
the individuals on Schedule 9 hereto shall have been
appointed officers of EPIX and shall serve in such capacity
effective as of the Effective Time. |
ARTICLE VII
TERMINATION
7.1. TERMINATION. This
Agreement may be terminated at any time prior to the Effective
Time, notwithstanding approval thereof by the Board of Directors
and stockholders of Predix and EPIX:
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(a) by mutual written consent duly authorized by the Boards
of Directors of EPIX and Predix; or |
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(b) by either EPIX or Predix if the Merger shall not have
been consummated by July 31, 2006; provided, that
the right to terminate this Agreement under this
Section 7.1(b) shall not be available to any party whose
failure to fulfill any obligation under this Agreement has been
the cause of or resulted in the failure of the Merger to occur
on or before such date; or |
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(c) by either EPIX or Predix if a court of competent
jurisdiction or governmental, regulatory or administrative
agency or commission shall have issued a non-appealable final
order, decree or ruling or taken any other action, in each case
having the effect of permanently restraining, enjoining or
otherwise prohibiting the Merger; or |
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(d) by EPIX, if the Board of Directors of Predix shall have
withheld or withdrawn its recommendation in favor of the
Merger; or |
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(e) by EPIX, if there shall have occurred any Material
Adverse Effect with respect to Predix since the date of this
Agreement; or |
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(f) by Predix, if the Board of Directors of EPIX shall have
withheld or withdrawn its recommendation in favor of the
Merger; or |
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(g) by Predix, if there shall have occurred any Material
Adverse Effect with respect to EPIX since the date of this
Agreement; or |
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(h) by either EPIX or Predix, if the required approval of
the stockholders of EPIX or Predix contemplated by this
Agreement shall not have been obtained by reason of the failure
to obtain the requisite vote upon a vote taken at a meeting of
stockholders convened therefor or at any adjournment thereof;
provided, that the right to terminate this Agreement
under this Section 7.1(h) shall not be |
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available to any party where the failure to obtain stockholder
approval of such party shall have been caused by the action or
failure to act of such party in breach of this Agreement; or |
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(i) by either EPIX or Predix, upon a breach of any covenant
or agreement on the part of Predix or EPIX, respectively, set
forth in this Agreement, in either case, such that the
conditions set forth in Section 6.2(b) or
Section 6.3(b), would not be satisfied (a
Terminating Breach), provided, that,
if such Terminating Breach is curable prior to the expiration of
five (5) days from its occurrence (but in no event later
than July 31, 2006) by EPIX or Predix, as the case may be,
through the exercise of its commercially reasonable efforts and
for so long as EPIX or Predix, as the case may be, continues to
exercise such commercially reasonable efforts, neither Predix
nor EPIX, respectively, may terminate this Agreement under this
Section 7.1(i) unless such
5-day period expires
without such Terminating Breach having been cured; or |
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(j) by either EPIX or Predix, if either is not in material
breach of any of its obligations under that agreement, if any
representation or warranty on the part of the other party set
forth in this Agreement proves to have been untrue on the date
hereof, if such failure to be true would reasonably be likely to
have a Material Adverse Effect. |
7.2. NOTICE OF TERMINATION;
EFFECT OF TERMINATION. Any termination of this Agreement
under Section 7.1 above will be effective immediately upon
the delivery of written notice of the terminating party to the
other parties hereto. In the event of the termination of this
Agreement pursuant to Section 7.1, this Agreement shall
forthwith become void and there shall be no liability on the
part of any party hereto or any of its affiliates, directors,
officers or stockholders except that nothing herein shall
relieve any party from liability for any willful breach hereof.
No termination of this Agreement shall affect the obligations of
the parties contained in the Confidentiality Agreement, all of
which obligations shall survive termination of this Agreement in
accordance with its terms.
7.3. FEES AND EXPENSES.
(a) Except as set forth in Section 5.4 and this
Section 7.3, all fees and expenses incurred in connection
with this Agreement and the transactions contemplated hereby
shall be paid by the party incurring such expenses, whether or
not the Merger is consummated; in addition, EPIX shall be solely
responsible for all fees and expenses incurred in relation to
the preparation, printing and filing of the Joint Proxy
Statement (including the preliminary materials related thereto)
and the Registration Statement, in each case, including without
limitation any amendments or supplements thereto.
(b) Predix shall pay EPIX a fee of $4,500,000 upon the
termination of this Agreement by EPIX pursuant to
Section 7.1(d), 7.1(e), 7.1(h) or 7.1(i).
(c) EPIX shall pay Predix a fee of $4,500,000 upon the
termination of this Agreement by Predix pursuant to
Section 7.1(f), 7.1(g), 7.1(h) or 7.1(i).
(d) The fee payable pursuant to Sections 7.3(b) and
7.3(c) shall be paid within three (3) business days after
the termination of this Agreement pursuant to Article VII.
ARTICLE VIII
GENERAL PROVISIONS
8.1. EFFECTIVENESS OF
REPRESENTATIONS, WARRANTIES AND AGREEMENTS. Except as
otherwise provided in this Agreement, the representations,
warranties and agreements of each party hereto shall remain
operative and in full force and effect regardless of any
investigation made by or on behalf of any other party hereto,
any person controlling any such party or any of their officers
or directors, whether prior to or after the execution of this
Agreement. Except as provided elsewhere in this Agreement, the
representations, warranties and agreements in this Agreement
shall terminate at the Effective Time or upon the termination of
this Agreement pursuant to Section 7.1, as the case may be,
except that the agreements which, by their terms, survive the
Effective Time shall survive the Effective Time indefinitely and
those set forth in Section 7.3 shall survive termination
indefinitely. The
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Confidentiality Agreement shall remain in full force and effect
and shall survive termination of this Agreement as provided
therein.
8.2. NOTICES. All notices
and other communications given or made pursuant hereto shall be
in writing and shall be deemed to have been duly given or made
as of the date delivered if delivered personally, three
(3) days after being sent by registered or certified mail
(postage prepaid, return receipt requested), one day after
dispatch by recognized overnight courier (provided delivery is
confirmed by the carrier) and upon transmission by telecopy,
confirmed received, to the parties at the following addresses
(or at such other address for a party as shall be specified by
like changes of address):
(a) If to EPIX or Merger Sub:
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EPIX Pharmaceuticals, Inc. |
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161 First Street |
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Cambridge, MA 02142 |
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Attn: Chief Executive Officer |
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With a copy to: |
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. |
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One Financial Center |
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Boston, MA 02111 |
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Attn: William T. Whelan, Esq. |
(b) If to Predix:
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Predix Pharmaceuticals Holdings, Inc. |
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4 Maguire Road |
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Lexington, MA 02421 |
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Attn: President and Chief Executive Officer |
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With a copy to: |
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Goodwin Procter LLP |
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Exchange Place |
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53 State Street |
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Boston, MA 02109 |
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Attn.: Lawrence S. Wittenberg, Esq. |
8.3. CERTAIN DEFINITIONS.
For purposes of this Agreement, the term:
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(a) affiliates means a person that
directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with, the
first mentioned person, including, without limitation, any
partnership or joint venture in which Predix or EPIX, as the
case may be, (either alone, or through or together with any
other subsidiary) has, directly or indirectly, an interest of
ten percent (10%) or more; |
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(b) business day means any day other
than a day on which banks in Boston, Massachusetts are required
or authorized to be closed; |
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(c) person means a person, corporation,
partnership, association, trust, unincorporated organization,
other entity or group (as defined in Section 13(d)(3) of
the Exchange Act); |
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(d) subsidiary or
subsidiaries of the Surviving Corporation,
EPIX, Predix or any other person means any corporation,
partnership, joint venture or other legal entity of which the
Surviving Corporation, EPIX, Predix or such other person, as the
case may be (either alone or through or together with any other
subsidiary), owns, directly or indirectly, more than fifty
percent (50%) of the stock or other equity interests the holders
of which are generally entitled to vote for the election of the
board of directors or other governing body of such corporation
or other legal entity; and |
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(e) trading day means any day on which
the NASDAQ is open and available for at least five
(5) hours for the trading of EPIX Common Stock. |
8.4. AMENDMENT. This
Agreement may be amended by the parties hereto by action taken
by or on behalf of their respective Boards of Directors at any
time prior to the Effective Time; provided,
however, that, after the Boards of Directors of EPIX and
Predix approve this Agreement and declare its advisability and
after the stockholders of each of EPIX and Predix adopt this
Agreement, no amendment may be made which by law requires
further approval by such stockholders or Boards of Directors
without such further approval. This Agreement may not be amended
except by an instrument in writing signed by the parties hereto.
8.5. WAIVER. At any time
prior to the Effective Time, any party hereto may, with respect
to any other party hereto, (a) extend the time for the
performance of any of the obligations or other acts,
(b) waive any inaccuracies in the representations and
warranties contained herein or in any document delivered
pursuant hereto and (c) waive compliance with any of the
agreements or conditions contained herein. Any such extension or
waiver shall be valid if set forth in an instrument in writing
signed by the party or parties to be bound.
8.6. HEADINGS. The headings
contained in this Agreement are for reference purposes only and
shall not affect in any way the meaning or interpretation of
this Agreement.
8.7. SEVERABILITY. If any
term or other provision of this Agreement is invalid, illegal or
incapable of being enforced by any rule of law, or public
policy, all other conditions and provisions of this Agreement
shall nevertheless remain in full force and effect so long as
the economic or legal substance of the transactions contemplated
hereby is not affected in any manner adverse to any party. Upon
such determination that any term or other provision is invalid,
illegal or incapable of being enforced, the parties hereto shall
negotiate in good faith to modify this Agreement so as to effect
the original intent of the parties as closely as possible in an
acceptable manner to the end that transactions contemplated
hereby are fulfilled to the extent possible.
8.8. ENTIRE AGREEMENT. This
Agreement constitutes the entire agreement and supersedes all
prior agreements and undertakings (other than the
Confidentiality Agreement), both written and oral, among the
parties, or any of them, with respect to the subject matter
hereof and, except as otherwise expressly provided herein, are
not intended to confer upon any other person any rights or
remedies hereunder.
8.9. ASSIGNMENT. No party
may assign this Agreement or any of its rights, interests or
obligations hereunder without the prior written approval of the
other parties hereto.
8.10. PARTIES IN INTEREST.
This Agreement shall be binding upon and inure solely to the
benefit of each party hereto, and nothing in this Agreement,
expressed or implied, is intended to or shall confer upon any
other person any right, benefit or remedy of any nature
whatsoever under or by reason of this Agreement, other than
Section 5.8 (which is intended to be for the benefit of the
Indemnified Parties and may be enforced by such Indemnified
Parties).
8.11. FAILURE OR INDULGENCE NOT
WAIVER; REMEDIES CUMULATIVE. No failure or delay on the part
of any party hereto in the exercise of any right hereunder shall
impair such right or be construed to be a waiver of, or
acquiescence in, any breach of any representation, warranty or
agreement herein, nor shall any single or partial exercise of
any such right preclude other or further exercise thereof or of
any other right. All rights and remedies existing under this
Agreement are cumulative to, and not exclusive of, any rights or
remedies otherwise available.
8.12. GOVERNING LAW. This
agreement shall be governed by, and construed in accordance
with, the internal laws of the State of Delaware applicable to
contracts executed and fully performed within the State of
Delaware.
8.13. OTHER REMEDIES; SPECIFIC
PERFORMANCE. Except as otherwise provided herein, any and
all remedies herein expressly conferred upon a party will be
deemed cumulative with and not
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exclusive of any other remedy conferred hereby, or by law or
equity upon such party, and the exercise by a party of any one
remedy will not preclude the exercise of any other remedy. The
parties hereto agree that irreparable damage would occur in the
event that any of the provisions of this Agreement were not
performed in accordance with their specific terms or were
otherwise breached. It is accordingly agreed that the parties
shall be entitled to seek an injunction or injunctions to
prevent breaches of this Agreement and to enforce specifically
the terms and provisions hereof in any court of the United
States or any state having jurisdiction, this being the addition
to any other remedy to which they are entitled at law or in
equity.
8.14. COUNTERPARTS. This
Agreement may be executed in one or more counterparts, and by
the different parties hereto in separate counterparts, each of
which when executed shall be deemed to be an original but all of
which taken together shall constitute one and the same agreement.
[THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, EPIX, Merger Sub, and Predix have caused
this Agreement to be executed as of the date first written above
by their respective officers or representatives thereunto duly
authorized.
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EPIX PHARMACEUTICALS, INC. |
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By: |
/s/ Michael J. Astrue |
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Name: Michael J. Astrue |
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Title: Chief Executive Officer |
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EPIX DELAWARE, INC. |
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Name: Philip T. Chase |
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Title: Treasurer and Secretary |
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PREDIX PHARMACEUTICALS HOLDINGS, INC. |
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By: |
/s/ Michael G. Kauffman |
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Name: Michael G. Kauffman, M.D., Ph.D. |
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Title: President and Chief Executive Officer |
A-57
ANNEX B
FORM OF VOTING AGREEMENT
VOTING AGREEMENT (the Agreement), dated as of
April 3, 2006, between the undersigned stockholder (the
Stockholder) of Predix Pharmaceuticals
Holdings, Inc., a Delaware corporation (the
Predix), and EPIX Pharmaceuticals, Inc., a
Delaware corporation (EPIX).
WHEREAS, concurrently with the execution of this Agreement,
Predix, EPIX and EPIX Delaware, Inc., a Delaware
corporation and a wholly-owned subsidiary of EPIX
(Merger Sub), have entered into an Agreement
and Plan of Merger (as the same may be amended and restated from
time to time, the Merger Agreement),
providing for, inter alia, the merger (the
Merger) of Predix with Merger Sub pursuant to
the terms and conditions of the Merger Agreement;
WHEREAS, as a condition to their willingness to enter into the
Merger Agreement, EPIX and Merger Sub have requested that the
Stockholder make certain representations, warranties, covenants
and agreements with respect to the shares of Predix common
stock, par value $.01 per share (the Predix Common
Stock), Predix Preferred Stock, par value
$.01 per share (the Predix Preferred
Stock), and Predix Common Stock issuable upon the
exercise of options or warrants or the conversion of convertible
securities (the Predix Convertible Shares,
together with the Predix Common Stock and the Predix Preferred
Stock, the Shares) beneficially owned by the
Stockholder and set forth below the Stockholders signature
on the signature page hereto (the Stockholder
Shares); and
WHEREAS, in order to induce EPIX and Merger Sub to enter into
the Merger Agreement, the Stockholder is willing to make certain
representations, warranties, covenants and agreements with
respect to the Stockholder Shares.
NOW, THEREFORE, in consideration of the premises and for other
good and valuable consideration, the receipt, sufficiency and
adequacy of which is hereby acknowledged, the parties hereto
agree as follows:
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1. Representations of
Stockholders. Stockholder represents and warrants to
EPIX and Merger Sub that (a) Stockholder lawfully owns
beneficially (as such term is defined in
Rule 13d-3 under
the Securities Exchange Act of 1934, as amended (the
Exchange Act)) and of record all of the
Stockholder Shares free and clear of all liens, claims, charges,
security interests or other encumbrances (other than pursuant to
this Agreement, the Merger Agreement, the agreements set forth
on Exhibit A attached hereto or state or federal
securities laws) and, except pursuant to this Agreement, the
Merger Agreement, the agreements set forth on
Exhibit A attached hereto or state or federal
securities laws, there are no options, warrants or other rights,
agreements, arrangements or commitments of any character to
which Stockholder is a party relating to the pledge, disposition
or voting of any Shares and there are no voting trusts or voting
agreements with respect to the Stockholder Shares,
(b) Stockholder does not beneficially own any Shares other
than the Stockholder Shares and except as set forth below
Stockholders signature on the signature page hereto, does
not have any options, warrants or other rights to acquire any
additional Shares or any security exercisable for or convertible
into Shares, and (c) Stockholder has full power and
authority to enter into, execute and deliver this Agreement and
to perform fully Stockholders obligations hereunder. This
Agreement has been duly executed and delivered and constitutes
the legal, valid and binding obligation of Stockholder in
accordance with its terms. |
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2. Agreement to Vote Shares;
Irrevocable Proxy. |
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(a) Stockholder agrees during the term of this Agreement to
vote the Stockholder Shares and any New Shares (as defined in
Section 6 hereof) beneficially owned by the Stockholder at
the record date for determining stockholders of record entitled
to vote upon the Merger and the Merger Agreement at every
meeting of the stockholders of Predix at which such matters are
considered and at every adjournment or postponement thereof or
by written consent: (i) in favor of adoption and approval
of the Merger Agreement and the Merger, (ii) against any
action that |
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would preclude fulfillment of a condition under the Merger
Agreement to EPIXs or Merger Subs obligation to
consummate the Merger, (iii) against any action or
agreement that would result in a breach in any material respect
of any covenant, representation or warranty or any other
obligation of Predix under the Merger Agreement and
(iv) except for the Merger and the Merger Agreement,
against any Acquisition Proposal (as defined in the Merger
Agreement). |
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(b) Stockholder hereby appoints EPIX and any designee of
EPIX, and each of them individually, its proxies and
attorneys-in-fact, with
full power of substitution and resubstitution, to vote or act by
written consent during the term of this Agreement with respect
to the Stockholder Shares and any New Shares in accordance with
Section 2(a). This proxy is given to secure the performance
of the duties of Stockholder under this Agreement. Stockholder
shall take such further action or execute such other instruments
as may be necessary to effectuate the intent of this proxy. The
proxy and power of attorney granted pursuant hereto by
Stockholder shall be irrevocable during the term of this
Agreement, shall be deemed to be coupled with an interest
sufficient in law to support an irrevocable proxy and shall
revoke any and all prior proxies granted by Stockholder. The
power of attorney granted by Stockholder herein is a durable
power of attorney and shall survive the dissolution, bankruptcy,
death or incapacity of Stockholder. The proxy and power of
attorney granted hereunder shall terminate upon the termination
of this Agreement. |
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3. No Voting Trusts or Other
Arrangements. Stockholder agrees that Stockholder will
not, and will not permit any entity under Stockholders
control to, deposit any of the Stockholder Shares in a voting
trust, grant any proxies with respect to the Stockholder Shares
or subject any of the Stockholder Shares to any arrangement with
respect to the voting of the Stockholder Shares other than
agreements entered into with EPIX. |
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4. No Proxy
Solicitations. Stockholder agrees that Stockholder will
not, and will not permit any entity under Stockholders
control to, (a) solicit proxies or become a
participant in a solicitation (as such
terms are defined in Regulation 14A under the Exchange Act)
in opposition to or competition with the approval of the Merger
Agreement or the consummation of the Merger or otherwise
encourage or assist any party in taking or planning any action
which would reasonably be expected to compete with, impede,
interfere with or attempt to discourage the Merger or inhibit
the timely consummation of the Merger in accordance with the
terms of the Merger Agreement, (b) directly or indirectly
encourage, initiate or cooperate in a stockholders vote or
action by written consent of Predixs stockholders in
opposition to or in competition with the approval of the Merger
Agreement or the consummation of the Merger or (c) become a
member of a group (as such term is used in
Rule 13d-5 under
the Exchange Act) with respect to any voting securities of
Predix for the purpose of opposing or competing with the
approval of the Merger Agreement or the consummation of the
Merger; provided, however, that nothing in this
Agreement shall prevent Stockholder from taking any action or
omitting to take any action solely as a member of the Board of
Directors of Predix (or any committee thereof) or as an officer
of Predix or any of its subsidiaries. |
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5. Transfer and
Encumbrance. On or after the date hereof and during the
term of this Agreement, Stockholder agrees not to transfer
(except pursuant to the Merger Agreement or as otherwise
required by law or court order), sell, offer, exchange, pledge
or otherwise dispose of or encumber any of the Stockholder
Shares or New Shares. |
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6. Additional
Purchases. Stockholder agrees that all Shares that
Stockholder purchases, acquires the right to vote or share in
the voting of, or otherwise acquires beneficial ownership of
after the execution of this Agreement (New
Shares), shall be subject to the terms of this
Agreement to the same extent as if they constituted Stockholder
Shares. |
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7. Specific
Performance. Each party hereto acknowledges that it will
be impossible to measure in money the damage to the other party
if a party hereto fails to comply with any of the obligations
imposed by this Agreement, that every such obligation is
material and that, in the event of any such failure, the other
party will not have an adequate remedy at law or damages.
Accordingly, each party |
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hereto agrees that injunctive relief or other equitable remedy,
in addition to remedies at law or damages, is the appropriate
remedy for any such failure and will not oppose the granting of
such relief on the basis that the other party has an adequate
remedy at law. Each party hereto agrees that it will not seek,
and agrees to waive any requirement for, the securing or posting
of a bond in connection with any other partys seeking or
obtaining such equitable relief. |
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8. No Agreement as Director
or Officer. Stockholder makes no agreement or
understanding in this Agreement in Stockholders capacity
as a director or officer of Predix or any of its subsidiaries,
and nothing in this Agreement will limit or affect any actions
or omissions taken by Stockholder in Stockholders capacity
as a director or officer of Predix or any of its subsidiaries
including in exercising rights under the Merger Agreement, and
no such actions or omissions shall be deemed a breach of this
Agreement. |
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9. Entire Agreement.
This Agreement supersedes all prior agreements, written or oral,
among the parties hereto with respect to the subject matter
hereof and contains the entire agreement among the parties with
respect to the subject matter hereof. This Agreement may not be
amended or supplemented, and no provisions hereof may be
modified or waived, except by an instrument in writing signed by
all the parties hereto. No waiver of any provisions hereof by
any party shall be deemed a waiver of any other provisions
hereof by any such party, nor shall any such waiver be deemed a
continuing waiver of any provision hereof by such party. |
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10. Notices. All
notices, requests, claims, demands or other communications
hereunder shall be in writing and shall be deemed given when
delivered personally, upon receipt of a transmission
confirmation if sent by telecopy, facsimile or like transmission
and on the next business day when sent by Federal Express,
Express Mail or other reputable overnight courier service to the
parties at the following addresses (or at such other address for
a party as shall be specified by like notice): |
If to EPIX:
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EPIX Pharmaceuticals, Inc. |
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161 First Street |
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Cambridge, MA 02142 |
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Attention: Chief Executive Officer |
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Facsimile No.: (617) 250-6031 |
With a copy to:
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. |
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One Financial Center |
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Boston, MA 02111 |
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Attention: William T. Whelan, Esq. |
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Facsimile No.: (617) 542-2241 |
If to Stockholder:
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To the address or facsimile number set forth for Stockholder on
the |
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signature page hereof. |
With a copy to:
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Goodwin Procter LLP |
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Exchange Place |
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53 State Street |
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Boston, MA 02109 |
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Attn.: Lawrence S. Wittenberg, Esq. |
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Facsimile No.:
(617) 523-1231 |
B-3
11. Miscellaneous.
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(a) THIS AGREEMENT SHALL BE DEEMED TO BE MADE IN AND IN
ALL RESPECTS SHALL BE INTERPRETED, CONSTRUED AND GOVERNED BY AND
IN ACCORDANCE WITH THE LAWS OF THE STATE OF DELAWARE WITHOUT
REGARD TO THE CONFLICT OF LAW PRINCIPLES THEREOF. The
parties hereby irrevocably submit to the jurisdiction of the
courts of the Commonwealth of Massachusetts and the Federal
courts of the United States of America, in each case, located in
the City of Boston, Massachusetts solely in respect of the
interpretation and enforcement of the provisions of this
Agreement and hereby waive, and agree not to assert, as a
defense in any action, suit or proceeding for the interpretation
or enforcement hereof or of any such document, that it is not
subject thereto or that such action, suit or proceeding may not
be brought or is not maintainable in said courts or that the
venue thereof may not be appropriate or that this Agreement may
not be enforced in or by such courts, and the parties hereto
irrevocably agree that all claims with respect to such action or
proceeding shall be heard and determined in such courts. The
parties hereby consent to and grant any such court jurisdiction
over the person of such parties and over the subject matter of
such dispute and agree that mailing of process or other papers
in connection with any such action or proceeding in the manner
provided in Section 10 hereof or in such other manner as
may be permitted by law shall be valid and sufficient service
thereof. |
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EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH
MAY ARISE UNDER THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED
AND DIFFICULT ISSUES, AND THEREFORE EACH SUCH PARTY HEREBY
IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT SUCH PARTY MAY
HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR
INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT. EACH PARTY
CERTIFIES AND ACKNOWLEDGES THAT (i) NO REPRESENTATIVE,
AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY
OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF
LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (ii) EACH
PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF THIS
WAIVER, (iii) EACH PARTY MAKES THIS WAIVER VOLUNTARILY, AND
(iv) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS
AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND
CERTIFICATIONS IN THIS SECTION 11(a). |
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(b) If any provision of this Agreement or the application
of such provision to any person or circumstances shall be held
invalid or unenforceable by a court of competent jurisdiction,
such provision or application shall be unenforceable only to the
extent of such invalidity or unenforceability and the remainder
of the provision held invalid or unenforceable and the
application of such provision to persons or circumstances, other
than the party as to which it is held invalid, and the remainder
of this Agreement, shall not be affected. |
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(c) This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original
but all of which together shall constitute one and the same
instrument. |
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(d) This Agreement and all proxies and powers of attorney
granted or provided pursuant hereto shall terminate upon the
earliest to occur of (i) the Effective Time (as defined in
the Merger Agreement) or (ii) the date on which the Merger
Agreement is terminated in accordance with its terms. |
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(e) Each party hereto shall execute and deliver such
additional documents as may be necessary or desirable to effect
the transactions contemplated by this Agreement. |
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(f) All Section headings herein are for convenience of
reference only and are not part of |
B-4
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this Agreement, and no construction or reference shall be
derived therefrom. |
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(g) The obligations of Stockholder set forth in this
Agreement shall not be effective or binding upon Stockholder
until after such time as the Merger Agreement is executed and
delivered by Predix, EPIX and Merger Sub, and the parties agree
that there is not and has not been any other agreement,
arrangement or understanding between the parties hereto with
respect to the matters set forth herein. |
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(h) No party to this Agreement may assign any of its right
or obligations under this Agreement without the prior written
consent of the other party hereto, except that EPIX may assign
its rights and obligations hereunder to any of its direct or
indirect wholly-owned subsidiaries (including Merger Sub). Any
assignment contrary to the provisions of this Section 11(h)
shall be null and void. |
[THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK]
B-5
IN WITNESS WHEREOF, the parties hereto have executed and
delivered this Agreement as of the date first written above.
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EPIX PHARMACEUTICALS, INC. |
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By: |
/s/ Michael J. Astrue |
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Name: Michael J. Astrue |
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Title: Chief Executive Officer |
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STOCKHOLDER |
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CADUCEUS PRIVATE INVESTMENT, L.P. |
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By: |
/s/ Eric A. Bittelman |
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Name: Eric A. Bittelman |
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Title: CFO, OrbiMed Advisors, LLC |
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Address: 767 Third Avenue
30th Floor |
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New York, NY 10017 |
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Facsimile No.: (212) 739-6444 |
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No. of Shares Held |
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No. of Shares Beneficially |
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Beneficially Owned: |
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Common: |
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Preferred: |
37,034,684 |
Acknowledged and Agreed to:
PREDIX PHARMACEUTICALS HOLDINGS, INC.
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By: |
/s/ Michael G. Kauffman |
Name: Michael G. Kauffman, M.D., Ph.D.
B-6
Schedule of Other Stockholders Signing
This Form of Voting Agreement
PA INTERNATIONAL LIMITED
UBS PW JUNIPER CROSSOVER FUND, L.L.C.
HARE AND COMPANY FAO: FINSBURY WORLDWIDE PHARMA
YAMANOUCHI VENTURE CAPITAL
PCM VENTURE CAPITAL L.P.
YOZMA II (ISRAEL) L.P.
YVC-YOZMA MANAGEMENT & INVESTMENTS LTD., AS TRUSTEE FOR
YOZMA II (B.V.I.) L.P.
YOZMA VENTURE CAPITAL LTD.
Exhibit A
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1. |
Second Amended and Restated Stockholders Agreement by and among
Predix and certain Stockholders dated as of January 21,
2005. |
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2. |
Co-Sale Agreement by and among Takhus, Inc. and certain
Stockholders dated October 12, 1995, as amended. |
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3. |
Form of Incentive Stock Option Agreement granted under
Predixs 2003 Stock Incentive Plan. |
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4. |
Form of Nonstatutory Stock Option Agreement granted under
Predixs 2003 Stock Incentive Plan. |
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5. |
Form of Restricted Stock Agreement granted under Predixs
2003 Stock Incentive Plan. |
ANNEX C
[LETTERHEAD OF NEEDHAM & COMPANY, LLC]
March 30, 2006
CONFIDENTIAL
Board of Directors
EPIX Pharmaceuticals, Inc.
161 First Street
Cambridge, MA 02142
Gentlemen:
We understand that EPIX Pharmaceuticals, Inc.
(EPIX), EPIX Delaware, Inc., a wholly-owned
subsidiary of EPIX (Subsidiary), and Predix
Pharmaceuticals Holdings, Inc. (Predix) propose to
enter into an Agreement and Plan of Merger (the Merger
Agreement) whereby, upon the terms and subject to the
conditions set forth in the Merger Agreement, Predix will merge
with and into the Subsidiary, with the Subsidiary surviving the
merger (the Merger). The terms of the Merger are set
forth more fully in the Merger Agreement.
You have requested our opinion as to the fairness, from a
financial point of view, to EPIX and to the holders of Common
Stock of EPIX of the consideration to be paid by EPIX in the
proposed Merger.
For purposes of this opinion we have, among other things:
(i) reviewed a draft of the Merger Agreement dated
March 29, 2006, together with the exhibits and schedules
thereto; (ii) reviewed certain publicly available
information concerning EPIX and Predix and certain other
relevant financial and operating data of EPIX and Predix
furnished to us by EPIX and Predix; (iii) held discussions
with members of management of EPIX and Predix concerning the
business, operations and prospects of EPIX and Predix and the
combined company, including the potential cost savings and other
synergies that may be achieved by the combined company;
(iv) reviewed certain materials prepared by EPIX concerning
the business, operations and prospects of EPIX and Predix and
the combined company; (v) reviewed certain materials
prepared by Predix concerning the business, operations and
prospects of Predix; (vi) reviewed certain financial
forecasts with respect to EPIX and Predix and the combined
company prepared by the management of EPIX; (vii) reviewed
certain financial forecasts with respect to Predix prepared by
the management of Predix; (viii) compared certain publicly
available financial data of companies whose securities are
traded in the public markets and that we deemed relevant to
similar data for EPIX; (ix) reviewed the trading history of
EPIXs Common Stock; (x) reviewed the financial terms
of certain other business combinations that we deemed generally
relevant; and (xi) performed and/or considered such other
studies, analyses, inquiries, correspondence and investigations
as we deemed appropriate.
In connection with our review and in arriving at our opinion, we
have assumed and relied on the accuracy and completeness of all
of the financial and other information discussed with or
reviewed by us for purposes of this opinion and have neither
attempted to verify independently nor assumed responsibility for
verifying any of such information. In addition, we have assumed,
with your consent, that the proposed Merger will qualify as a
reorganization within the meaning of Section 368(a) of the
Internal Revenue Code of 1986, as amended, and that the proposed
Merger will be consummated upon the terms and subject to the
conditions set forth in the draft Merger Agreement dated
March 29, 2006 without material alteration or waiver
thereof. With respect to the financial forecasts of EPIX, Predix
and the combined company provided to us by the management of
EPIX, the financial forecasts of Predix provided to us by the
management of Predix, and the prospects of the combined company,
we have assumed, with your consent and based upon discussions
with such managements, that such forecasts have been reasonably
prepared on bases reflecting the best currently available
estimates and judgments of such managements, at the time of
preparation, of the future operating and financial performance
of EPIX and Predix and the combined company. We have relied,
without independent verification, upon the estimates of such
managements of the potential cost savings and other synergies,
including the amount and timing thereof,
C-1
that may be achieved as a result of the proposed Merger. We
express no opinion with respect to such forecasts or estimates
or the assumptions upon which they are based.
We have relied on the advice of counsel and independent
accountants to EPIX as to all legal and financial reporting
matters with respect to EPIX, the Merger and the Merger
Agreement. We have not assumed any responsibility for or made or
obtained any independent evaluation, appraisal or physical
inspection of the assets or liabilities of EPIX or Predix. Our
opinion does not address the underlying business decision of
EPIX to engage in the Merger. Further, our opinion is based on
economic, monetary and market conditions as they exist and can
be evaluated as of the date hereof, and we assume no
responsibility to update or revise our opinion based upon
circumstances and events occurring after the date hereof.
Needham & Company, LLC, as part of its investment
banking business, is regularly engaged in the valuation of
businesses and their securities in connection with mergers and
acquisitions, negotiated underwritings, secondary distributions
of securities, private placements and other purposes. We have
been engaged by EPIX to render this opinion in connection with
the Merger and will receive a fee for our services, a portion of
which is contingent on delivery of this opinion. In addition,
EPIX has agreed to indemnify us for certain liabilities arising
out of the rendering of this opinion and to reimburse us for our
reasonable
out-of-pocket expenses.
We have in the past provided and may in the future provide
investment banking and financial advisory services to EPIX
unrelated to the proposed Merger, for which services we have
received and expect to receive compensation. A private equity
fund in which an affiliate of Needham & Company, LLC
has invested is a stockholder of Predix. In the ordinary course
of our business, we may actively trade the equity securities of
EPIX for our own account or for the accounts of customers and,
accordingly, may at any time hold a long or short position in
such securities.
This letter and the opinion expressed herein are solely for the
use and benefit of the Board of Directors of EPIX and, except as
set forth below, may not be disclosed, in whole or in part, or
summarized, excerpted from or referred to without our prior
written consent. If this opinion is required by applicable law
to be included in a proxy statement or other similar statement
filed with the Securities and Exchange Commission and provided
to securityholders of EPIX in connection with the Merger, this
opinion will be reproduced in such statement in full, and any
description of or reference to Needham & Company, LLC
or summary of this opinion in such statement will be in a form
reasonably acceptable to Needham & Company, LLC and its
counsel.
Based upon and subject to the foregoing, it is our opinion that,
as of the date hereof, the consideration to be paid by EPIX in
the proposed Merger is fair to EPIX and to the holders of Common
Stock of EPIX from a financial point of view.
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Very truly yours, |
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/s/ David S. Schechner |
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David S. Schechner |
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Managing Director |
C-2
ANNEX D
§ 262. Appraisal rights.
(a) Any stockholder of a corporation of this State who
holds shares of stock on the date of the making of a demand
pursuant to subsection (d) of this section with
respect to such shares, who continuously holds such shares
through the effective date of the merger or consolidation, who
has otherwise complied with subsection (d) of this
section and who has neither voted in favor of the merger or
consolidation nor consented thereto in writing pursuant to
§ 228 of this title shall be entitled to an appraisal
by the Court of Chancery of the fair value of the
stockholders shares of stock under the circumstances
described in subsections (b) and (c) of this section.
As used in this section, the word stockholder means
a holder of record of stock in a stock corporation and also a
member of record of a nonstock corporation; the words
stock and share mean and include what is
ordinarily meant by those words and also membership or
membership interest of a member of a nonstock corporation; and
the words depository receipt mean a receipt or other
instrument issued by a depository representing an interest in
one or more shares, or fractions thereof, solely of stock of a
corporation, which stock is deposited with the depository.
(b) Appraisal rights shall be available for the shares of
any class or series of stock of a constituent corporation in a
merger or consolidation to be effected pursuant to
§ 251 (other than a merger effected pursuant to
§ 251(g) of this title), § 252,
§ 254, § 257, § 258,
§ 263 or § 264 of this title:
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(1) Provided, however, that no appraisal rights under this
section shall be available for the shares of any class or series
of stock, which stock, or depository receipts in respect
thereof, at the record date fixed to determine the stockholders
entitled to receive notice of and to vote at the meeting of
stockholders to act upon the agreement of merger or
consolidation, were either (i) listed on a national
securities exchange or designated as a national market system
security on an interdealer quotation system by the National
Association of Securities Dealers, Inc. or (ii) held of
record by more than 2,000 holders; and further provided that no
appraisal rights shall be available for any shares of stock of
the constituent corporation surviving a merger if the merger did
not require for its approval the vote of the stockholders of the
surviving corporation as provided in subsection (f) of
§ 251 of this title. |
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(2) Notwithstanding paragraph (1) of this
subsection, appraisal rights under this section shall be
available for the shares of any class or series of stock of a
constituent corporation if the holders thereof are required by
the terms of an agreement of merger or consolidation pursuant to
§§ 251, 252, 254, 257, 258, 263 and 264 of this
title to accept for such stock anything except: |
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a Shares of stock of the corporation surviving or resulting
from such merger or consolidation, or depository receipts in
respect thereof; |
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b. Shares of stock of any other corporation, or depository
receipts in respect thereof, which shares of stock (or
depository receipts in respect thereof) or depository receipts
at the effective date of the merger or consolidation will be
either listed on a national securities exchange or designated as
a national market system security on an interdealer quotation
system by the National Association of Securities Dealers, Inc.
or held of record by more than 2,000 holders; |
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c. Cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.
and b. of this paragraph; or |
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d. Any combination of the shares of stock, depository
receipts and cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.,
b. and c. of this paragraph. |
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(3) In the event all of the stock of a subsidiary Delaware
corporation party to a merger effected under § 253 of
this title is not owned by the parent corporation immediately
prior to the merger, appraisal rights shall be available for the
shares of the subsidiary Delaware corporation. |
D-1
(c) Any corporation may provide in its certificate of
incorporation that appraisal rights under this section shall be
available for the shares of any class or series of its stock as
a result of an amendment to its certificate of incorporation,
any merger or consolidation in which the corporation is a
constituent corporation or the sale of all or substantially all
of the assets of the corporation. If the certificate of
incorporation contains such a provision, the procedures of this
section, including those set forth in subsections (d) and
(e) of this section, shall apply as nearly as is
practicable.
(d) Appraisal rights shall be perfected as follows:
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(1) If a proposed merger or consolidation for which
appraisal rights are provided under this section is to be
submitted for approval at a meeting of stockholders, the
corporation, not less than 20 days prior to the meeting,
shall notify each of its stockholders who was such on the record
date for such meeting with respect to shares for which appraisal
rights are available pursuant to subsection (b) or
(c) hereof that appraisal rights are available for any or
all of the shares of the constituent corporations, and shall
include in such notice a copy of this section. Each stockholder
electing to demand the appraisal of such stockholders
shares shall deliver to the corporation, before the taking of
the vote on the merger or consolidation, a written demand for
appraisal of such stockholders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such stockholders
shares. A proxy or vote against the merger or consolidation
shall not constitute such a demand. A stockholder electing to
take such action must do so by a separate written demand as
herein provided. Within 10 days after the effective date of
such merger or consolidation, the surviving or resulting
corporation shall notify each stockholder of each constituent
corporation who has complied with this subsection and has not
voted in favor of or consented to the merger or consolidation of
the date that the merger or consolidation has become
effective; or |
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(2) If the merger or consolidation was approved pursuant to
§ 228 or § 253 of this title, then either a
constituent corporation before the effective date of the merger
or consolidation or the surviving or resulting corporation
within 10 days thereafter shall notify each of the holders
of any class or series of stock of such constituent corporation
who are entitled to appraisal rights of the approval of the
merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such
constituent corporation, and shall include in such notice a copy
of this section. Such notice may, and, if given on or after the
effective date of the merger or consolidation, shall, also
notify such stockholders of the effective date of the merger or
consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice,
demand in writing from the surviving or resulting corporation
the appraisal of such holders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such holders shares. If
such notice did not notify stockholders of the effective date of
the merger or consolidation, either (i) each such
constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of
the holders of any class or series of stock of such constituent
corporation that are entitled to appraisal rights of the
effective date of the merger or consolidation or (ii) the
surviving or resulting corporation shall send such a second
notice to all such holders on or within 10 days after such
effective date; provided, however, that if such second notice is
sent more than 20 days following the sending of the first
notice, such second notice need only be sent to each stockholder
who is entitled to appraisal rights and who has demanded
appraisal of such holders shares in accordance with this
subsection. An affidavit of the secretary or assistant secretary
or of the transfer agent of the corporation that is required to
give either notice that such notice has been given shall, in the
absence of fraud, be prima facie evidence of the facts stated
therein. For purposes of determining the stockholders entitled
to receive either notice, each constituent corporation may fix,
in advance, a record date that shall be not more than
10 days prior to the date the notice is given, provided,
that if the notice is given on or after the effective date of
the merger or consolidation, the record date shall be such
effective date. If no record date is fixed and the notice is
given prior to the |
D-2
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effective date, the record date shall be the close of business
on the day next preceding the day on which the notice is given. |
(e) Within 120 days after the effective date of the
merger or consolidation, the surviving or resulting corporation
or any stockholder who has complied with subsections
(a) and (d) hereof and who is otherwise entitled to
appraisal rights, may file a petition in the Court of Chancery
demanding a determination of the value of the stock of all such
stockholders. Notwithstanding the foregoing, at any time within
60 days after the effective date of the merger or
consolidation, any stockholder shall have the right to withdraw
such stockholders demand for appraisal and to accept the
terms offered upon the merger or consolidation. Within
120 days after the effective date of the merger or
consolidation, any stockholder who has complied with the
requirements of subsections (a) and (d) hereof, upon
written request, shall be entitled to receive from the
corporation surviving the merger or resulting from the
consolidation a statement setting forth the aggregate number of
shares not voted in favor of the merger or consolidation and
with respect to which demands for appraisal have been received
and the aggregate number of holders of such shares. Such written
statement shall be mailed to the stockholder within 10 days
after such stockholders written request for such a
statement is received by the surviving or resulting corporation
or within 10 days after expiration of the period for
delivery of demands for appraisal under
subsection (d) hereof, whichever is later.
(f) Upon the filing of any such petition by a stockholder,
service of a copy thereof shall be made upon the surviving or
resulting corporation, which shall within 20 days after
such service file in the office of the Register in Chancery in
which the petition was filed a duly verified list containing the
names and addresses of all stockholders who have demanded
payment for their shares and with whom agreements as to the
value of their shares have not been reached by the surviving or
resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be
accompanied by such a duly verified list. The Register in
Chancery, if so ordered by the Court, shall give notice of the
time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting
corporation and to the stockholders shown on the list at the
addresses therein stated. Such notice shall also be given by 1
or more publications at least 1 week before the day of the
hearing, in a newspaper of general circulation published in the
City of Wilmington, Delaware or such publication as the Court
deems advisable. The forms of the notices by mail and by
publication shall be approved by the Court, and the costs
thereof shall be borne by the surviving or resulting corporation.
(g) At the hearing on such petition, the Court shall
determine the stockholders who have complied with this section
and who have become entitled to appraisal rights. The Court may
require the stockholders who have demanded an appraisal for
their shares and who hold stock represented by certificates to
submit their certificates of stock to the Register in Chancery
for notation thereon of the pendency of the appraisal
proceedings; and if any stockholder fails to comply with such
direction, the Court may dismiss the proceedings as to such
stockholder.
(h) After determining the stockholders entitled to an
appraisal, the Court shall appraise the shares, determining
their fair value exclusive of any element of value arising from
the accomplishment or expectation of the merger or
consolidation, together with a fair rate of interest, if any, to
be paid upon the amount determined to be the fair value. In
determining such fair value, the Court shall take into account
all relevant factors. In determining the fair rate of interest,
the Court may consider all relevant factors, including the rate
of interest which the surviving or resulting corporation would
have had to pay to borrow money during the pendency of the
proceeding. Upon application by the surviving or resulting
corporation or by any stockholder entitled to participate in the
appraisal proceeding, the Court may, in its discretion, permit
discovery or other pretrial proceedings and may proceed to trial
upon the appraisal prior to the final determination of the
stockholder entitled to an appraisal. Any stockholder whose name
appears on the list filed by the surviving or resulting
corporation pursuant to subsection (f) of this section
and who has submitted such stockholders certificates of
stock to the Register in Chancery, if such is required, may
participate fully in all proceedings until it is finally
determined that such stockholder is not entitled to appraisal
rights under this section.
D-3
(i) The Court shall direct the payment of the fair value of
the shares, together with interest, if any, by the surviving or
resulting corporation to the stockholders entitled thereto.
Interest may be simple or compound, as the Court may direct.
Payment shall be so made to each such stockholder, in the case
of holders of uncertificated stock forthwith, and the case of
holders of shares represented by certificates upon the surrender
to the corporation of the certificates representing such stock.
The Courts decree may be enforced as other decrees in the
Court of Chancery may be enforced, whether such surviving or
resulting corporation be a corporation of this State or of any
state.
(j) The costs of the proceeding may be determined by the
Court and taxed upon the parties as the Court deems equitable in
the circumstances. Upon application of a stockholder, the Court
may order all or a portion of the expenses incurred by any
stockholder in connection with the appraisal proceeding,
including, without limitation, reasonable attorneys fees
and the fees and expenses of experts, to be charged pro rata
against the value of all the shares entitled to an appraisal.
(k) From and after the effective date of the merger or
consolidation, no stockholder who has demanded appraisal rights
as provided in subsection (d) of this section shall be
entitled to vote such stock for any purpose or to receive
payment of dividends or other distributions on the stock (except
dividends or other distributions payable to stockholders of
record at a date which is prior to the effective date of the
merger or consolidation); provided, however, that if no petition
for an appraisal shall be filed within the time provided in
subsection (e) of this section, or if such stockholder
shall deliver to the surviving or resulting corporation a
written withdrawal of such stockholders demand for an
appraisal and an acceptance of the merger or consolidation,
either within 60 days after the effective date of the
merger or consolidation as provided in
subsection (e) of this section or thereafter with the
written approval of the corporation, then the right of such
stockholder to an appraisal shall cease. Notwithstanding the
foregoing, no appraisal proceeding in the Court of Chancery
shall be dismissed as to any stockholder without the approval of
the Court, and such approval may be conditioned upon such terms
as the Court deems just.
(l) The shares of the surviving or resulting corporation to
which the shares of such objecting stockholders would have been
converted had they assented to the merger or consolidation shall
have the status of authorized and unissued shares of the
surviving or resulting corporation.
D-4
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 20. Indemnification of
Directors and Officers.
The Companys Restated Certificate of Incorporation, as
amended (the Restated Certificate) provides that the
Company shall indemnify to the fullest extent authorized by the
Delaware General Corporation Law (DGCL), each person
who is involved in any litigation or other proceeding because
such person is or was a director or officer of the Company or is
or was serving as an officer or director of another entity at
the request of the Company, against expenses (including
attorneys fees), judgments, fines and amounts reasonably
incurred in connection therewith. The Restated Certificate
provides that the right to indemnification includes the right to
be paid expenses incurred in defending any proceeding in advance
of its final disposition; provided, however, that such advance
payment will only be made upon delivery to the Company of an
undertaking, by the director or officer, to repay all amounts so
advanced if it is ultimately determined that such director or
officer is not entitled to indemnification.
Section 145 of the DGCL permits a corporation to indemnify
any director or officer of the corporation against expenses
(including attorneys fees), judgments, fines and amounts
paid in settlement actually and reasonably incurred in
connection with any action, suit or proceeding brought by reason
of the fact that such person is or was a director or officer of
the corporation, if such person acted in good faith and in a
manner that he or she reasonably believed to be in, or not
opposed to, the best interests of the corporation, and, with
respect to any criminal action or proceeding, if he or she had
no reason to believe his or her conduct was unlawful. In a
derivative action, (i.e., one brought by or on behalf of the
corporation), indemnification may be made only for expenses,
actually and reasonably incurred by any director or officer in
connection with the defense or settlement of such an action or
suit, if such person acted in good faith and in a manner that he
reasonably believed to be in, or not opposed to, the best
interests of the corporation, except that no indemnification
shall be made if such person shall have been adjudged to be
liable to the corporation, unless and only to the extent that
the court in which the action or suit was brought shall
determine that the defendant is fairly and reasonably entitled
to indemnity for such expenses despite such adjudication of
liability.
Pursuant to Section 102(b)(7) of the DGCL, the Restated
Certificate eliminates the liability of a director or the
corporation or its stockholders for monetary damages for such
breach of fiduciary duty as a director, except for liabilities
arising (i) from any breach of the directors duty of
loyalty to the corporation or its stockholders, (ii) from
acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) under
Section 174 of the DGCL, or (iv) from any transaction
from which the director derived an improper personal benefit.
The Company has obtained insurance policies insuring the
directors and officers of the Company against certain
liabilities that they may incur in their capacity as directors
and officers.
The Company has entered into indemnification agreements (the
Indemnification Agreements), with each of its
directors and certain of its officers. The Indemnification
Agreements provide that the Company will, to the fullest extent
permitted by law, pay any attorneys fees and all other
costs, expenses and obligations paid or incurred by the
indemnitee in connection with claims against him or her related
to the fact that he or she was a director or officer of the
Company or serving at the request of the Company in such
capacity with another corporation, partnership, joint venture,
employee benefit plan, trust or other enterprise. The payments
to be made under the Indemnification Agreements include
expenses, judgments, fines, penalties and amounts paid in
settlement (including all interest, assessments and other
judgments, fines, penalties or amounts paid in settlement) of
such claims. If requested by the indemnitee, the Company shall
advance all expenses to the indemnitee. Any payments made by the
Company under the Indemnification Agreements are subrogated to
all of the rights of recovery of the indemnitee. The rights of
the indmenitee are in addition to such rights the indemnitee may
have under the Companys Restated Certificate, the
Companys by-laws and the DGCL.
II-1
Pursuant to the merger agreement, upon the completion of the
merger, the combined company will fulfill and honor the
obligations of Predix which existed prior to the merger to
indemnify Predixs present and former directors and
officers. The certificate of incorporation and by-laws of the
combined company will provide for the indemnification and
elimination of liability for monetary damages to the same extent
as set forth in Predixs certificate of incorporation and
by-laws and such provision may not be amended, repealed or
otherwise modified for a period of six years after the
completion of the merger in any manner that would adversely
affect the rights of the directors or officers of Predix at the
time of the completion of the merger. After the completion of
the merger, the combined company will, to the fullest extent
permitted under law and under its certificate of incorporation,
indemnify and hold harmless, each present and former director
and officer of Predix in respect of acts or omissions occurring
prior to the completion of the merger, including in connection
with the merger agreement and the transactions contemplated
thereby, to the same extent as provided in Predixs
certificate of incorporation, by-laws or any applicable contract
or agreement for a period of six years after the completion of
the merger. The Company has agreed to guarantee the timely
payment of all funds owing by, and the timely performance of all
obligations of the combined company relating to these
indemnification obligations.
|
|
Item 21. |
Exhibits and Financial Statement Schedules. |
(a) Exhibits
|
|
|
|
|
Number |
|
Description |
|
|
|
|
2 |
.1 |
|
Agreement and Plan of Merger, dated as of April 3, 2006,
among EPIX Pharmaceuticals, Inc., EPIX Delaware, Inc. and Predix
Pharmaceuticals Holdings, Inc. (included as Annex A to the
joint proxy statement/ prospectus). |
|
3 |
.1@ |
|
Restated Certificate of Incorporation of EPIX Pharmaceuticals
Inc. Filed as Exhibit 4.1 to EPIX Pharmaceuticals
Inc.s Registration Statement on Form S-8 (File
No. 333-30531) and incorporated herein by reference. |
|
3 |
.2@ |
|
Certificate of Amendment of Restated Certificate of
Incorporation of EPIX Pharmaceuticals Inc. Filed as
Exhibit 3.2 to EPIX Pharmaceuticals Inc.s Annual
Report on Form 10-K for the year ended December 31,
2001 (File No. 000-21863) and incorporated herein by
reference. |
|
3 |
.3@ |
|
Certificate of Amendment of Restated Certificate of
Incorporation of EPIX Pharmaceuticals Inc. Filed as
Exhibit 3.2 to EPIX Pharmaceuticals Inc.s Quarterly
Report on Form 10-Q for the period ended September 30,
2004 (File No. 000-21863) and incorporated herein by
reference. |
|
3 |
.4@ |
|
Form of Amended and Restated By-Laws of EPIX Pharmaceuticals
Inc. Filed as Exhibit 4.2 to EPIX Pharmaceuticals
Inc.s Registration Statement on Form S-8 (File
No. 333-30531) and incorporated herein by reference. |
|
4 |
.1@ |
|
Specimen certificate for shares of Common Stock of EPIX
Pharmaceuticals Inc. Filed as Exhibit 4.1 to EPIX
Pharmaceuticals Inc.s Registration Statement on
Form S-1 (File No. 333-17581) and incorporated herein
by reference. |
|
4 |
.2@ |
|
Indenture, dated as of June 7, 2004, between EPIX
Pharmaceuticals, Inc. and U.S. Bank National Association as
Trustee, relating to 3% Convertible Senior Notes due
June 15, 2024. Filed as Exhibit 4.1 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
filed June 7, 2004 (File No. 000-21863) and
incorporated herein by reference. |
|
5 |
.1** |
|
Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
regarding the legality of the securities. |
|
8 |
.1** |
|
Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
regarding tax matters. |
|
8 |
.2** |
|
Opinion of Goodwin Procter LLP regarding tax matters. |
|
10 |
.1@+ |
|
Amended and Restated License Agreement between EPIX
Pharmaceuticals, Inc. and The General Hospital Corporation dated
July 10, 1995. Filed as Exhibit 10.14 to EPIX
Pharmaceuticals, Inc.s Registration Statement on
Form S-1 (File No. 333-17581) and incorporated herein
by reference. |
II-2
|
|
|
|
|
Number |
|
Description |
|
|
|
|
10 |
.2@# |
|
Amended and Restated 1992 Equity Incentive Plan. Filed as
Appendix A to EPIX Pharmaceuticals, Inc.s 2003
Definitive Proxy Statement on Schedule 14A (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.3@# |
|
Form of Incentive Stock Option Certificate. Filed as
Exhibit 10.29 to EPIX Pharmaceuticals, Inc.s
Registration Statement on Form S-1 (File
No. 333-17581) and incorporated herein by reference. |
|
10 |
.4@# |
|
Form of Nonstatutory Stock Option Certificate. Filed as
Exhibit 10.30 to EPIX Pharmaceuticals, Inc.s
Registration Statement on Form S-1 (File
No. 333-17581) and incorporated herein by reference. |
|
10 |
.5@# |
|
Amended and Restated 1996 Director Stock Option Plan. Filed
as Appendix B to EPIX Pharmaceuticals, Inc.s 2003
Definitive Proxy Statement on Schedule 14A (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.6@# |
|
Amended and Restated 1996 Employee Stock Purchase Plan. Filed as
Appendix C to EPIX Pharmaceuticals, Inc.s 2003
Definitive Proxy Statement on Schedule 14A (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.7@ |
|
Short Form Lease from Trustees of the Cambridge Trust to
EPIX Pharmaceuticals, Inc. with a commencement date of
January 1, 1998. Filed as Exhibit 10.39 to EPIX
Pharmaceuticals, Inc.s Registration Statement on
Form S-1 (File No. 333-38399) and incorporated herein
by reference. |
|
10 |
.8@ |
|
First Amendment dated February 8, 1999 to the Short
Form Lease dated as of July 7, 1998 with a
commencement date as of January 1, 1998 between EPIX
Pharmaceuticals, Inc. and the Trustees of The Cambridge East
Trust. Filed as Exhibit 10.1 to EPIX Pharmaceuticals,
Inc.s Quarterly Report on Form 10-Q for the period
ended March 31, 1999 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.9@ |
|
Second Amendment dated June 30, 2000 to the Short
Form Lease dated as of July 7, 1998 with a
commencement date as of January 1, 1998 between EPIX
Pharmaceuticals, Inc. and the Trustees of The Cambridge East
Trust. Filed as Exhibit 10.1 to EPIX Pharmaceuticals,
Inc.s Quarterly Report on Form 10-Q for the period
ended June 30, 2000 and incorporated herein by reference. |
|
10 |
.10@++ |
|
Amended and Restated Strategic Collaboration Agreement dated
June 9, 2000, among EPIX Pharmaceuticals, Inc.,
Tyco/Mallinckrodt Inc. (a Delaware corporation) and
Tyco/Mallinckrodt Inc. (a New York corporation). Filed as
Exhibit 10.1 to EPIX Pharmaceuticals, Inc.s Current
Report on Form 8-K dated June 29, 2000 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.11@++ |
|
Strategic Collaboration Agreement dated as of June 9, 2000,
between EPIX Pharmaceuticals, Inc. and Schering
Aktiengesellschaft. Filed as Exhibit 10.2 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated June 29, 2000 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.12@ |
|
Stock Purchase Agreement, dated as of June 9, 2000, between
EPIX Pharmaceuticals, Inc. and Schering Berlin Venture
Corporation. Filed as Exhibit 10.3 to EPIX Pharmaceuticals,
Inc.s Current Report on Form 8-K dated June 29,
2000 (File No. 000-21863) and incorporated herein by
reference. |
|
10 |
.13@ |
|
Standstill Agreement, dated as of June 9, 2000, between
EPIX Pharmaceuticals, Inc. and Schering Berlin Venture
Corporation. Filed as Exhibit 10.4 to EPIX Pharmaceuticals,
Inc.s Current Report on Form 8-K dated June 29,
2000 (File No. 000-21863) and incorporated herein by
reference. |
|
10 |
.14@++ |
|
Reacquisition Agreement dated December 22, 2000 between
EPIX Pharmaceuticals, Inc. and Daiichi Radioisotope
Laboratories, Ltd. Filed as Exhibit 10.32 to EPIX
Pharmaceuticals, Inc.s Annual Report on Form 10-K for
the period ended December 31, 2000 (File
No. 000-21863) and incorporated herein by reference. |
II-3
|
|
|
|
|
Number |
|
Description |
|
|
|
|
10 |
.15@ |
|
Amendment No. 1 dated as of December 22, 2000 to the
Strategic Collaboration Agreement, dated as of June 9,
2000, between EPIX Pharmaceuticals, Inc. and Schering
Aktiengesellschaft. Filed as Exhibit 10.33 to EPIX
Pharmaceuticals, Inc.s Annual Report on Form 10-K for
the period ended December 31, 2000 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.16@++ |
|
Worldwide License Agreement, dated as of September 25,
2001, by and between EPIX Pharmaceuticals, Inc. and Bracco
Imaging S.p.A. filed as Exhibit 10.1 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated September 25, 2001 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.17@ |
|
Settlement and Release Agreement dated as of September 25,
2001, by and between EPIX Pharmaceuticals, Inc. and Bracco
Imaging S.p.A. filed as Exhibit 10.2 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated September 25, 2001 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.18@ |
|
Third Amendment, dated May 21, 2002, to the Short
Form Lease dated as July 7, 1998 with a commencement
date as of January 1, 1998 between EPIX Pharmaceuticals,
Inc. and the Trustees of the Cambridge East Trust. Filed as an
Exhibit 10.31 to EPIX Pharmaceuticals, Inc.s
Quarterly Report on Form 10-Q for the period ended
June 30, 2002 (File No. 000-21863) and incorporated
herein by reference. |
|
10 |
.19@++ |
|
Thrombus Development Agreement between EPIX Pharmaceuticals,
Inc. and Schering AG, dated as of May 26, 2003. Filed as
Exhibit 10.1 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended June 30, 2003
(File No. 000-21863) and incorporated herein by reference. |
|
10 |
.20@++ |
|
Collaborative Research Agreement between EPIX Pharmaceuticals,
Inc. and Schering AG, dated as of May 26, 2003. Filed as
Exhibit 10.2 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended June 30, 2003
(File No. 000-21863) and incorporated herein by reference. |
|
10 |
.21@++ |
|
Lease of premises at 161 First Street, Cambridge, Massachusetts
from BHX, LLC, as Trustee of First Binney Realty Trust to EPIX
Pharmaceuticals, Inc., dated as of September 30, 2003 and
executed on October 10, 2003. Filed as Exhibit 10.22
to EPIX Pharmaceuticals, Inc.s Annual Report on
Form 10-K for the year ended December 31, 2003 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.22@ |
|
Intellectual Property Agreement by and between EPIX
Pharmaceuticals, Inc. and Dr. Martin R. Prince, dated
November 17, 2003. Filed as Exhibit 10.1 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated November 18, 2003 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.23@++ |
|
Stock Purchase Agreement by and between EPIX Pharmaceuticals,
Inc. and Dr. Martin R. Prince, dated as of
November 17, 3003. Filed as Exhibit 10.2 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated November 18, 2003 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.24@++ |
|
First Amendment dated October 8, 2004 to the Short
Form Lease dated as of September 30, 2003 with a
commencement date as of November 1, 2003 between EPIX
Pharmaceuticals, Inc. and the BHX, LLC, as Trustees of First
Binney Realty Trust. Filed as Exhibit 10.22 to EPIX
Pharmaceuticals, Inc.s Annual Report on Form 10-K for
the year ended December 31, 2003 (File No. 000-21863)
and incorporated by reference. |
|
10 |
.25@# |
|
Director Compensation Arrangements. Filed as Exhibit 10.27
to EPIX Pharmaceuticals, Inc.s Annual Report on
Form 10-K for the year ended December 31, 2004 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.26@# |
|
Named Executive Officer Compensation Arrangements. Filed with
EPIX Pharmaceuticals, Inc.s Current Report on
Form 8-K dated February 16, 2006 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.27@# |
|
Form of Indemnification Agreement. Filed as Exhibit 10.27
to EPIX Pharmaceuticals, Inc.s Annual Report on
Form 10-K for the year ended December 31, 2004 (File
No. 000-21863) and incorporated herein by reference. |
II-4
|
|
|
|
|
Number |
|
Description |
|
|
|
|
10 |
.28@# |
|
Form of Amendment to Stock Option Agreement. Filed as
Exhibit 10.30 to EPIX Pharmaceuticals, Inc.s Annual
Report on Form 10-K for the year ended December 31,
2004 (File No. 000-21863) and incorporated herein by
reference. |
|
10 |
.29@# |
|
Amendment to the Collaborative Research Agreement dated as of
May 26, 2003, between EPIX Pharmaceuticals, Inc. and
Schering Aktiengesellschaft, dated September 30, 2005.
Filed as Exhibit 99.1 to EPIX Pharmaceuticals, Inc.s
Current Report on Form 8-K filed October 7, 2005 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.30@# |
|
Employment Agreement between EPIX Pharmaceuticals, Inc. and
Michael J. Astrue, dated September 21, 2005. Filed as
Exhibit 10.1 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended September 30,
2005 (File No. 000-21863) and incorporated herein by
reference. |
|
10 |
.31@# |
|
Severance Agreement between EPIX Pharmaceuticals, Inc. and
Andrew Uprichard, M.D., dated September 14, 2005.
Filed as Exhibit 10.2 to EPIX Pharmaceuticals, Inc.s
Quarterly Report on Form 10-Q for the period ended
September 30, 2005 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.32@# |
|
Separation Agreement between EPIX Pharmaceuticals, Inc. and
Michael D. Webb, dated September 14, 2005. Filed as
Exhibit 10.4 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended September 30,
2005 (File No. 000-21863) and incorporated herein by
reference. |
|
10 |
.33 |
|
Form of Voting Agreement between EPIX Pharmaceuticals, Inc. and
certain stockholders of Predix Pharmaceuticals Holdings, Inc.
(included as Annex B to the joint proxy statement/
prospectus). |
|
21 |
.1* |
|
Subsidiaries of EPIX Pharmaceuticals, Inc. |
|
23 |
.1* |
|
Consent of Ernst & Young LLP, Independent Registered
Public Accounting Firm of EPIX Pharmaceuticals, Inc. |
|
23 |
.2* |
|
Consent of Ernst & Young LLP, Independent Auditors of
Predix Pharmaceuticals Holdings, Inc. |
|
23 |
.3** |
|
Consent of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C. (included in the opinion filed as
Exhibit 5.1 to this Registration Statement). |
|
23 |
.4** |
|
Consent of Goodwin Procter LLP (included in the opinion filed as
Exhibit 8.2 to this Registration Statement). |
|
24 |
.1 |
|
Power of Attorney (reference is made to the signature page of
this Registration Statement). |
|
99 |
.1 |
|
Fairness Opinion of Needham & Company, LLC, dated
March 30, 2006 (included as Annex C to the joint proxy
statement/ prospectus). |
|
99 |
.2* |
|
Consent of Needham & Company, LLC. |
|
99 |
.3* |
|
Form of EPIX Pharmaceuticals, Inc. Proxy Card. |
|
99 |
.4* |
|
Form of Predix Pharmaceuticals Holdings, Inc. Proxy Card. |
|
|
|
|
@ |
Incorporated by reference as indicated. |
|
|
|
|
** |
To be filed by amendment. |
|
|
# |
Identifies a management contract or compensatory plan or
agreement in which an executive officer or director of EPIX
Pharmaceuticals, Inc. participates. |
|
|
+ |
Certain confidential material contained in the document has been
omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of
1933, as amended. |
|
|
++ |
Certain confidential material contained in the document has been
omitted and filed separately with the Securities and Exchange
Commission pursuant to
Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. |
II-5
(b) Financial Statement Schedules
EPIX Financial Statements
Report of Independent Registered Public Accounting Firm
Balance Sheet as of December 31, 2005 and 2004
Statements of Operations for the Years Ended December 31,
2005, 2004 and 2003
Statements of Stockholders Equity for the Years Ended
December 31, 2005, 2004 and 2003
Statements of Cash Flows for the Years Ended December 31,
2005, 2004 and 2003
Notes to Financial Statements
Predix Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheet as of December 31, 2005 and 2004
Consolidated Statements of Operations for the Years Ended
December 31, 2005, 2004 and 2003
Consolidated Statements of Stockholders Equity for the
Years Ended December 31, 2005, 2004 and 2003
Consolidated Statements of Cash Flows for the Years Ended
December 31, 2005, 2004 and 2003
Notes to Consolidated Financial Statements
(a) The undersigned Registrant hereby undertakes:
|
|
|
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration
statement: |
|
|
|
(i) To include any prospectus required by
Section 10(a) (3) of the Securities Act of 1933; |
|
|
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement.
Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered)
and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of
prospectus filed with the Securities and Exchange Commission
pursuant to Rule 424(b) if, in the aggregate, the changes
in volume and price represent no more than a 20% change in the
maximum aggregate offering price set forth in the
Calculation of Registration Fee table in the
effective registration statement; |
|
|
(iii) To include any material information with respect to
the plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement; |
|
|
|
(2) That, for the purpose of determining any liability
under the Securities Act of 1933, each such post-effective
amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof; |
|
|
(3) To remove from registration by means of a
post-effective amendment any of the securities being registered
which remain unsold at the termination of the offering; |
|
|
(4) That, for purposes of determining any liability under
the Securities Act of 1933, each filing of the Registrants
annual report pursuant to section 13(a) or
section 15(d) of the Securities Exchange Act of 1934 (and,
where applicable, each filing of an employee benefit plans
annual report pursuant to section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration
statement relating to the |
II-6
|
|
|
securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide
offering thereof; |
|
|
(5) That prior to any public reoffering of the securities
registered hereunder through use of a prospectus which is a part
of this registration statement, by any person or party who is
deemed to be an underwriter within the meaning of
Rule 145(c), such reoffering prospectus will contain the
information called for by the applicable registration form with
respect to reofferings by persons who may be deemed
underwriters, in addition to the information called for by the
other items of the applicable form; |
|
|
(6) That every prospectus (i) that is filed pursuant
to paragraph (5) immediately preceding, or (ii) that
purports to meet the requirements of Section 10(a)(3) of
the Securities Act of 1933 and is used in connection with an
offering of securities subject to Rule 415, will be filed
as a part of an amendment to the registration statement and will
not be used until such amendment is effective, and that, for
purposes of determining any liability under the Securities Act
of 1933, each such post-effective amendment shall be deemed to
be a new registration statement relating to the securities
offered therein, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering
thereof; |
|
|
(7) To respond to requests for information that is
incorporated by reference into the joint proxy statement/
prospectus pursuant to Item 4, 10(b), 11 or 13 of this
Form, within one business day of receipt of such request, and to
send the incorporated documents by first class mail or other
equally prompt means. This includes information contained in
documents filed subsequent to the effective date of the
registration statement through the date of responding to the
request; and |
|
|
(8) To supply by means of a post-effective amendment all
information concerning a transaction, and EPIX being acquired
involved therein, that was not the subject of and included in
the registration statement when it became effective. |
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers
and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as
expressed in the Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the
registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
II-7
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, EPIX
Pharmaceuticals, Inc. has duly caused this registration
statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the city of Cambridge,
Commonwealth of Massachusetts, on April 24, 2006.
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EPIX PHARMACEUTICALS, INC. |
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By: |
/s/ Michael J. Astrue |
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Michael J. Astrue |
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Interim Chief Executive Officer |
POWER OF ATTORNEY
We, the undersigned officers and directors of EPIX
Pharmaceuticals, Inc., hereby severally constitute and appoint
Michael J. Astrue and Robert B. Pelletier, and each of them
singly (with full power to each of them to act alone), our true
and lawful
attorneys-in-fact and
agents, with full power of substitution and resubstitution in
each of them for him and in his name, place and stead, and in
any and all capacities, to sign any and all amendments
(including post-effective amendments) to this registration
statement (or any other registration statement for the same
offering that is to be effective upon filing pursuant to
Rule 462(b) under the Securities Act of 1933), and to file
the same, with all exhibits thereto and other documents in
connection therewith, with the Securities and Exchange
Commission, granting unto said
attorneys-in-fact and
agents, and each of them, full power and authority to do and
perform each and every act and thing requisite or necessary to
be done in and about the premises, as full to all intents and
purposes as he might or could do in person, hereby ratifying and
confirming all that said
attorneys-in-fact and
agents or any of them or their or his substitute or substitutes
may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons
in the capacities indicated on April 24, 2006:
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Signature |
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Title(s) |
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/s/ Michael J. Astrue
Michael J. Astrue |
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Interim Chief Executive Officer
(Principal Executive Officer) |
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/s/ Robert Pelletier
Robert Pelletier, CPA |
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Executive Director of Finance
(Principal Accounting Officer) |
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/s/ Christopher F. O. Gabrieli
Christopher F. O. Gabrieli |
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Chairman of the Board of Directors |
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/s/ Mark Leuchtenberger
Mark Leuchtenberger |
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Director |
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/s/ Gregory D. Phelps
Gregory D. Phelps |
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Director |
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/s/ Peter Wirth
Peter Wirth Esq. |
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Director |
II-8
EXHIBIT INDEX
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|
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Number |
|
Description |
|
|
|
|
2 |
.1 |
|
Agreement and Plan of Merger, dated as of April 3, 2006,
among EPIX Pharmaceuticals, Inc., EPIX Delaware, Inc. and Predix
Pharmaceuticals Holdings, Inc. (included as Annex A to the
joint proxy statement/ prospectus). |
|
3 |
.1@ |
|
Restated Certificate of Incorporation of EPIX Pharmaceuticals,
Inc. Filed as Exhibit 4.1 to EPIX Pharmaceuticals,
Inc.s Registration Statement on Form S-8 (File
No. 333-30531) and incorporated herein by reference. |
|
3 |
.2@ |
|
Certificate of Amendment of Restated Certificate of
Incorporation of EPIX Pharmaceuticals, Inc. Filed as
Exhibit 3.2 to EPIX Pharmaceuticals, Inc.s Annual
Report on Form 10-K for the year ended December 31,
2001 (File No. 000-21863) and incorporated herein by
reference. |
|
3 |
.3@ |
|
Certificate of Amendment of Restated Certificate of
Incorporation of EPIX Pharmaceuticals, Inc.s Filed as
Exhibit 3.2 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended September 30,
2004 (File No. 000-21863) and incorporated herein by
reference. |
|
3 |
.4@ |
|
Form of Amended and Restated By-Laws of EPIX Pharmaceuticals,
Inc. Filed as Exhibit 4.2 to EPIX Pharmaceuticals,
Incs. Registration Statement on Form S-8 (File
No. 333-30531) and incorporated herein by reference. |
|
4 |
.1@ |
|
Specimen certificate for shares of Common Stock of EPIX
Pharmaceuticals, Inc. Filed as Exhibit 4.1 to EPIX
Pharmaceuticals, Inc.s Registration Statement on
Form S-1 (File No. 333-17581) and incorporated herein
by reference. |
|
4 |
.2@ |
|
Indenture, dated as of June 7, 2004, between EPIX
Pharmaceuticals, Inc. and U.S. Bank National Association as
Trustee, relating to 3% Convertible Senior Notes due
June 15, 2024. Filed as Exhibit 4.1 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
filed June 7, 2004 (File No. 000-21863) and
incorporated herein by reference. |
|
5 |
.1** |
|
Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
regarding the legality of the securities. |
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8 |
.1** |
|
Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
regarding tax matters. |
|
8 |
.2** |
|
Opinion of Goodwin Procter LLP regarding tax matters. |
|
10 |
.1@+ |
|
Amended and Restated License Agreement between EPIX
Pharmaceuticals, Inc. and The General Hospital Corporation dated
July 10, 1995. Filed as Exhibit 10.14 to EPIX
Pharmaceuticals, Inc.s Registration Statement on
Form S-1 (File No. 333-17581) and incorporated herein
by reference. |
|
10 |
.2@# |
|
Amended and Restated 1992 Equity Incentive Plan. Filed as
Appendix A to EPIX Pharmaceuticals, Inc.s 2003
Definitive Proxy Statement on Schedule 14A (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.3@# |
|
Form of Incentive Stock Option Certificate. Filed as
Exhibit 10.29 to EPIX Pharmaceuticals, Inc.s
Registration Statement on Form S-1 (File
No. 333-17581) and incorporated herein by reference. |
|
10 |
.4@# |
|
Form of Nonstatutory Stock Option Certificate. Filed as
Exhibit 10.30 to EPIX Pharmaceuticals, Inc.s
Registration Statement on Form S-1 (File
No. 333-17581) and incorporated herein by reference. |
|
10 |
.5@# |
|
Amended and Restated 1996 Director Stock Option Plan. Filed
as Appendix B to EPIX Pharmaceuticals, Inc.s 2003
Definitive Proxy Statement on Schedule 14A (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.6@# |
|
Amended and Restated 1996 Employee Stock Purchase Plan. Filed as
Appendix C to EPIX Pharmaceuticals, Inc.s 2003
Definitive Proxy Statement on Schedule 14A (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.7@ |
|
Short Form Lease from Trustees of the Cambridge Trust to
EPIX Pharmaceuticals, Inc. with a commencement date of
January 1, 1998. Filed as Exhibit 10.39 to EPIX
Pharmaceuticals, Inc.s Registration Statement on
Form S-1 (File No. 333-38399) and incorporated herein
by reference. |
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|
|
Number |
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Description |
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|
|
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10 |
.8@ |
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First Amendment dated February 8, 1999 to the Short
Form Lease dated as of July 7, 1998 with a
commencement date as of January 1, 1998 between EPIX
Pharmaceuticals, Inc. and the Trustees of The Cambridge East
Trust. Filed as Exhibit 10.1 to EPIX Pharmaceuticals,
Inc.s Quarterly Report on Form 10-Q for the period
ended March 31, 1999 (File No. 000-21863) and incorporated
herein by reference. |
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10 |
.9@ |
|
Second Amendment dated June 30, 2000 to the Short
Form Lease dated as of July 7, 1998 with a
commencement date as of January 1, 1998 between EPIX
Pharmaceuticals, Inc. and the Trustees of The Cambridge East
Trust. Filed as Exhibit 10.1 to EPIX Pharmaceuticals,
Inc.s Quarterly Report on Form 10-Q for the period
ended June 30, 2000 and incorporated herein by reference. |
|
10 |
.10@++ |
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Amended and Restated Strategic Collaboration Agreement dated
June 9, 2000, among EPIX Pharmaceuticals, Inc., Tyco/
Mallinckrodt Inc. (a Delaware corporation) and Tyco/
Mallinckrodt Inc. (a New York corporation). Filed as
Exhibit 10.1 to EPIX Pharmaceuticals, Inc.s Current
Report on Form 8-K dated June 29, 2000 (File
No. 000-21863) and incorporated herein by reference. |
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10 |
.11@++ |
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Strategic Collaboration Agreement dated as of June 9, 2000,
between EPIX Pharmaceuticals, Inc. and Schering
Aktiengesellschaft. Filed as Exhibit 10.2 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated June 29, 2000 (File No. 000-21863) and
incorporated herein by reference. |
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10 |
.12@ |
|
Stock Purchase Agreement, dated as of June 9, 2000, between
EPIX Pharmaceuticals, Inc. and Schering Berlin Venture
Corporation. Filed as Exhibit 10.3 to EPIX Pharmaceuticals,
Inc.s Current Report on Form 8-K dated June 29,
2000 (File No. 000-21863) and incorporated herein by
reference. |
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10 |
.13@ |
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Standstill Agreement, dated as of June 9, 2000, between
EPIX Pharmaceuticals, Inc. and Schering Berlin Venture
Corporation. Filed as Exhibit 10.4 to EPIX Pharmaceuticals,
Inc.s Current Report on Form 8-K dated June 29,
2000 (File No. 000-21863) and incorporated herein by
reference. |
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10 |
.14@++ |
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Reacquisition Agreement dated December 22, 2000 between
EPIX Pharmaceuticals, Inc. and Daiichi Radioisotope
Laboratories, Ltd. Filed as Exhibit 10.32 to EPIX
Pharmaceuticals, Inc.s Annual Report on Form 10-K for
the period ended December 31, 2000 (File
No. 000-21863) and incorporated herein by reference. |
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10 |
.15@ |
|
Amendment No. 1 dated as of December 22, 2000 to the
Strategic Collaboration Agreement, dated as of June 9,
2000, between EPIX Pharmaceuticals, Inc. and Schering
Aktiengesellschaft. Filed as Exhibit 10.33 to EPIX
Pharmaceuticals, Inc.s Annual Report on Form 10-K for
the period ended December 31, 2000 (File
No. 000-21863) and incorporated herein by reference. |
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10 |
.16@++ |
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Worldwide License Agreement, dated as of September 25,
2001, by and between EPIX Pharmaceuticals, Inc. and Bracco
Imaging S.p.A. filed as Exhibit 10.1 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated September 25, 2001 (File No. 000-21863) and
incorporated herein by reference. |
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10 |
.17@ |
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Settlement and Release Agreement dated as of September 25,
2001, by and between EPIX Pharmaceuticals, Inc. and Bracco
Imaging S.p.A. filed as Exhibit 10.2 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated September 25, 2001 (File No. 000-21863) and
incorporated herein by reference. |
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10 |
.18@ |
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Third Amendment, dated May 21, 2002, to the Short
Form Lease dated as July 7, 1998 with a commencement
date as of January 1, 1998 between EPIX Pharmaceuticals,
Inc. and the Trustees of the Cambridge East Trust. Filed as an
Exhibit 10.31 to EPIX Pharmaceuticals, Inc.s
Quarterly Report on Form 10-Q for the period ended
June 30, 2002 (File No. 000-21863) and incorporated
herein by reference. |
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10 |
.19@++ |
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Thrombus Development Agreement between EPIX Pharmaceuticals,
Inc. and Schering AG, dated as of May 26, 2003. Filed as
Exhibit 10.1 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended June 30, 2003
(File No. 000-21863) and incorporated herein by reference. |
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Number |
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Description |
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10 |
.20@++ |
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Collaborative Research Agreement between EPIX Pharmaceuticals,
Inc. and Schering AG, dated as of May 26, 2003. Filed as
Exhibit 10.2 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended June 30, 2003
(File No. 000-21863) and incorporated herein by reference. |
|
10 |
.21@++ |
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Lease of premises at 161 First Street, Cambridge, Massachusetts
from BHX, LLC, as Trustee of First Binney Realty Trust to EPIX
Pharmaceuticals, Inc., dated as of September 30, 2003 and
executed on October 10, 2003. Filed as Exhibit 10.22
to EPIX Pharmaceuticals, Inc.s Annual Report on
Form 10-K for the year ended December 31, 2003 (File
No. 000-21863) and incorporated herein by reference. |
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10 |
.22@ |
|
Intellectual Property Agreement by and between EPIX
Pharmaceuticals, Inc. and Dr. Martin R. Prince,
dated November 17, 2003. Filed as Exhibit 10.1 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated November 18, 2003 (File No. 000-21863) and
incorporated herein by reference. |
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10 |
.23@++ |
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Stock Purchase Agreement by and between EPIX Pharmaceuticals,
Inc. and Dr. Martin R. Prince, dated as of
November 17, 3003. Filed as Exhibit 10.2 to EPIX
Pharmaceuticals, Inc.s Current Report on Form 8-K
dated November 18, 2003 (File No. 000-21863) and
incorporated herein by reference. |
|
10 |
.24@++ |
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First Amendment dated October 8, 2004 to the Short
Form Lease dated as of September 30, 2003 with a
commencement date as of November 1, 2003 between EPIX
Pharmaceuticals, Inc. and the BHX, LLC, as Trustees of First
Binney Realty Trust. Filed as Exhibit 10.22 to EPIX
Pharmaceuticals, Inc.s Annual Report on Form 10-K for
the year ended December 31, 2003 (File No. 000-21863)
and incorporated by reference. |
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10 |
.25@# |
|
Director Compensation Arrangements. Filed as Exhibit 10.27
to EPIX Pharmaceuticals, Inc.s Annual Report on
Form 10-K for the year ended December 31, 2004 (File
No. 000-21863) and incorporated herein by reference. |
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10 |
.26@# |
|
Named Executive Officer Compensation Arrangements. Filed with
EPIX Pharmaceuticals, Inc.s Current Report on
Form 8-K dated February 16, 2006 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.27@# |
|
Form of Indemnification Agreement. Filed as Exhibit 10.27
to EPIX Pharmaceuticals, Inc.s Annual Report on
Form 10-K for the year ended December 31, 2004 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.28@# |
|
Form of Amendment to Stock Option Agreement. Filed as
Exhibit 10.30 to EPIX Pharmaceuticals, Inc.s Annual
Report on Form 10-K for the year ended December 31,
2004 (File No. 000-21863) and incorporated herein by
reference. |
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10 |
.29@# |
|
Amendment to the Collaborative Research Agreement dated as of
May 26, 2003, between EPIX Pharmaceuticals, Inc. and
Schering Aktiengesellschaft, dated September 30, 2005.
Filed as Exhibit 99.1 to EPIX Pharmaceuticals, Inc.s
Current Report on Form 8-K filed October 7, 2005 (File
No. 000-21863) and incorporated herein by reference. |
|
10 |
.30@# |
|
Employment Agreement between EPIX Pharmaceuticals, Inc. and
Michael J. Astrue, dated September 21, 2005. Filed as
Exhibit 10.1 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended September 30,
2005 (File No. 000-21863) and incorporated herein by
reference. |
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10 |
.31@# |
|
Severance Agreement between EPIX Pharmaceuticals, Inc. and
Andrew Uprichard, M.D., dated September 14, 2005.
Filed as Exhibit 10.2 to EPIX Pharmaceuticals, Inc.s
Quarterly Report on Form 10-Q for the period ended
September 30, 2005 (File No. 000-21863) and
incorporated herein by reference. |
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10 |
.32@# |
|
Separation Agreement between EPIX Pharmaceuticals, Inc. and
Michael D. Webb, dated September 14, 2005. Filed as
Exhibit 10.4 to EPIX Pharmaceuticals, Inc.s Quarterly
Report on Form 10-Q for the period ended September 30,
2005 (File No. 000-21863) and incorporated herein by
reference. |
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10 |
.33 |
|
Form of Voting Agreement between EPIX Pharmaceuticals, Inc. and
certain stockholders of Predix Pharmaceuticals Holdings, Inc.
(included as Annex B to the joint proxy statement/
prospectus). |
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21 |
.1* |
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Subsidiaries of EPIX Pharmaceuticals, Inc. |
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|
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|
|
Number |
|
Description |
|
|
|
|
23 |
.1* |
|
Consent of Ernst & Young LLP, Independent Registered
Public Accounting Firm of EPIX Pharmaceuticals, Inc. |
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23 |
.2* |
|
Consent of Ernst & Young LLP, Independent Auditors of
Predix Pharmaceuticals Holdings, Inc. |
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23 |
.3** |
|
Consent of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C. (included in the opinion filed as
Exhibit 5.1 to this Registration Statement). |
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23 |
.4** |
|
Consent of Goodwin Procter LLP (included in the opinion filed as
Exhibit 8.2 to this Registration Statement). |
|
24 |
.1 |
|
Power of Attorney (reference is made to the signature page of
this Registration Statement). |
|
99 |
.1 |
|
Fairness Opinion of Needham & Company, LLC, dated
March 30, 2006 (included as Annex C to the joint proxy
statement/ prospectus). |
|
99 |
.2* |
|
Consent of Needham & Company, LLC. |
|
99 |
.3* |
|
Form of EPIX Pharmaceuticals, Inc. Proxy Card. |
|
99 |
.4* |
|
Form of Predix Pharmaceuticals Holdings, Inc. Proxy Card. |
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|
@ |
Incorporated by reference as indicated. |
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** |
To be filed by amendment. |
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# |
Identifies a management contract or compensatory plan or
agreement in which an executive officer or director of EPIX
Pharmaceuticals, Inc. participates. |
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+ |
Certain confidential material contained in the document has been
omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of
1933, as amended. |
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++ |
Certain confidential material contained in the document has been
omitted and filed separately with the Securities and Exchange
Commission pursuant to
Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. |