ImmunoGen, Inc. Form 10-Q
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
ý
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934
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For
the quarterly period ended September 30, 2006
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OR
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o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934
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For
the transition period from
to
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Commission
file number 0-17999
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ImmunoGen,
Inc.
Massachusetts
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04-2726691
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(State
or other jurisdiction of incorporation or organization)
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(I.R.S.
Employer Identification No.)
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128
Sidney Street, Cambridge, MA 02139
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(Address
of principal executive offices, including zip code)
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(617)
995-2500
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(Registrant's
telephone number, including area
code)
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Indicate
by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days.
ýYes o
No
Indicate
by check mark whether the registrant is a large accelerated
filer, an accelerated filer, or a non-accelerated filer. See definition
of
“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
accelerated filer
o
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Accelerated
filerý
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Non-accelerated
filer
o
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Indicate
by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act).
o
Yes ý No
Indicate
the number of shares outstanding of each of the issuer's
classes of common stock, as of the latest practicable date.
Shares
of common stock, par value $.01 per share: 41,541,834
shares outstanding as of November 1, 2006.
IMMUNOGEN,
INC.
TABLE
OF CONTENTS
PART
I.
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FINANCIAL
INFORMATION
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Item
1.
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a.
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b.
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c.
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d.
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Item
2.
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Item
3.
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Item
4.
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PART
II.
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Item
1.
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Item
1A.
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Item
2.
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Item
3.
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Item
4.
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Item
5.
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Item
6.
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CERTIFICATIONS
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CONSOLIDATED
BALANCE SHEETS
In
thousands,
except per share amounts
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September
30,
2006
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June
30,
2006
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(unaudited)
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ASSETS
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Cash
and cash
equivalents
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$
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6,276
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$
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4,813
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Marketable
securities
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64,000
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70,210
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Accounts
receivable
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2,266
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1,569
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Unbilled
revenue
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5,102
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5,419
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Inventory
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1,920
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1,235
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Prepaid
and other
current assets
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1,114
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1,298
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Total
current
assets
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80,678
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84,544
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Property
and
equipment, net of accumulated depreciation
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9,121
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9,319
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Other
assets
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218
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265
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Total
assets
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$
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90,017
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$
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94,128
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
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Accounts
payable
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$
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1,869
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$
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1,346
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Accrued
compensation
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1,146
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925
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Other
accrued
liabilities
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3,470
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3,129
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Current
portion of
deferred revenue
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5,879
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5,323
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Total
current
liabilities
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12,364
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10,723
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Deferred
revenue,
net of current portion
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10,297
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10,705
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Other
long-term
liabilities
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371
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350
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Total
liabilities
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23,032
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21,778
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Commitments
and
contingencies
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Stockholders’
equity:
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Common
stock, $.01
par value; authorized 75,000 shares; issued and outstanding 45,160
shares
and 45,149 shares as of September 30, 2006 and June 30, 2006,
respectively
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452
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451
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Additional
paid-in
capital
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322,494
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321,885
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Treasury
stock,
3,675 shares at September 30, 2006 and June 30, 2006 (at
cost)
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(11,071
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)
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(11,071
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)
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Accumulated
deficit
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(244,814
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)
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(238,561
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)
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Accumulated
other
comprehensive loss
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(76
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)
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(354
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)
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Total
stockholders’
equity
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66,985
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72,350
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Total
liabilities
and stockholders’ equity
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$
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90,017
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$
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94,128
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The
accompanying notes are an integral part of the consolidated financial
statements.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
In
thousands,
except per share amounts
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Three
Months
Ended
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September
30,
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2006
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2005
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Revenues:
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Research
and
development support
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$
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5,507
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$
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5,685
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License
and
milestone fees
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1,406
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1,261
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Clinical
materials
reimbursement
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857
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831
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Total
revenues
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7,770
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7,777
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Expenses:
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Cost
of clinical
materials reimbursed
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646
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905
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Research
and
development
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11,416
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9,492
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General
and
administrative
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2,797
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2,793
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Total
expenses
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14,859
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13,190
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Loss
from
operations
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(7,089
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)
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(5,413
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)
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Interest
income,
net
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865
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719
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Net
realized losses on investments
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(1
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)
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(4
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Gain
on sale of
assets
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-
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2
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Other
expense
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(18
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)
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-
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Loss
before income
tax expense
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$
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(6,243
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$
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(4,696
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Income
tax
expense
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10
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10
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Net
loss
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$
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(6,253
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$
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(4,706
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)
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Basic
and diluted
net loss per common share
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$
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(0.15
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$
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(0.11
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)
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Basic
and diluted
weighted average common shares outstanding
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41,482
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41,065
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The
accompanying notes are an integral part of the consolidated financial
statements.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
In
thousands,
except per share amounts
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Three
months
ended September 30,
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2006
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2005
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Cash
flows from
operating activities:
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Net
loss
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$
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(6,253
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)
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$
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(4,706
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)
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Adjustments
to
reconcile net loss to net cash used in operating
activities:
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Depreciation
and
amortization
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691
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650
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Gain
on sale of
fixed assets
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-
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(2
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)
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Loss
on sale of
marketable securities
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1
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4
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Stock-based
compensation
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647
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706
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Deferred
rent
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17
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1
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Changes
in operating
assets and liabilities:
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Accounts
receivable
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(697
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)
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(297
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)
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Unbilled
revenue
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317
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(860
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)
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Inventory
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(686
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)
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696
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Prepaid
and other
current assets
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184
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396
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Other
assets
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48
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48
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Accounts
payable
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522
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(747
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)
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Accrued
compensation
|
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221
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299
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Other
accrued
liabilities
|
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281
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274
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Deferred
revenue
|
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|
149
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|
75
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Net
cash used in operating activities
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(4,558
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)
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(3,463
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)
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Cash
flows from
investing activities:
|
|
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Proceeds
from
maturities or sales of marketable securities
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|
|
55,857
|
|
|
139,457
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|
Purchases
of
marketable securities
|
|
|
(49,369
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)
|
|
(136,669
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)
|
Capital
expenditures
|
|
|
(493
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)
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|
(498
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)
|
Proceeds
from sale
of fixed assets
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|
-
|
|
|
2
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|
Net
cash provided by investing activities
|
|
|
5,995
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|
|
2,292
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|
|
|
|
|
|
|
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Cash
flows from
financing activities:
|
|
|
|
|
|
|
|
Proceeds
from stock
options exercised
|
|
|
26
|
|
|
241
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|
Net
cash provided by financing activities
|
|
|
26
|
|
|
241
|
|
|
|
|
|
|
|
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Net
change in cash and cash equivalents
|
|
|
1,463
|
|
|
(930
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)
|
|
|
|
|
|
|
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|
Cash
and cash
equivalents, beginning balance
|
|
|
4,813
|
|
|
3,423
|
|
|
|
|
|
|
|
|
|
Cash
and cash
equivalents, ending balance
|
|
$
|
6,276
|
|
$
|
2,493
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure:
|
|
|
|
|
|
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|
Cash
paid for income
taxes
|
|
$
|
15
|
|
$
|
10
|
|
The
accompanying notes are an integral part of the consolidated financial
statements.
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
A. Summary
of
Significant Accounting Policies
Basis
of Presentation
The
accompanying consolidated financial statements at September 30, 2006 and June
30, 2006 and for the three months ended September 30, 2006 and 2005 include
the
accounts of ImmunoGen, Inc. (the “Company”) and its wholly-owned
subsidiaries, ImmunoGen Securities Corp. and ImmunoGen Europe Limited. Although
the consolidated financial statements are unaudited, they include all of the
adjustments, consisting only of normal recurring adjustments, which management
considers necessary for a fair presentation of the Company’s financial position
in accordance with accounting principles generally accepted in the US for
interim financial information. Certain information and footnote disclosures
normally included in the Company’s annual financial statements have been
condensed or omitted. The preparation of interim financial statements requires
the use of management’s estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the interim financial statements and the reported
amounts of revenues and expenditures during the reported period. The results
of
the interim periods are not necessarily indicative of the results for the entire
year. Accordingly, the interim financial statements should be read in
conjunction with the audited financial statements and notes thereto included
in
the Company’s Annual Report on Form 10-K for the year ended June 30,
2006.
Revenue
Recognition
The
Company enters into out-licensing and development agreements with collaborative
partners for the development of monoclonal antibody-based cancer therapeutics.
The Company follows the provisions of the Securities and Exchange Commission’s
Staff Accounting Bulletin No. 104 (SAB No. 104), Revenue
Recognition,
and Emerging Issues Task
Force 00-21 Accounting
for Revenue
Arrangements with Multiple Elements (EITF
00-21). In
accordance with SAB No. 104 and EITF 00-21, the Company recognizes
collaboration revenue related to research activities as they are performed,
as
long as there is persuasive evidence of an arrangement, the fee is fixed or
determinable, and collection of the related receivable is probable. The
Company recognizes revenue on preclinical and clinical materials when the
materials have passed all quality testing required for collaborator acceptance
and title has transferred to the collaborator. The terms
of the Company’s
agreements contain multiple elements, which typically include non-refundable
license fees, payments for research activities and clinical material
manufacturing obligations, payments based upon the achievement of certain
milestones, and royalties on product sales. The Company evaluates such
arrangements to determine if the deliverables are separable into units of
accounting and then applies applicable revenue recognition criteria to each
unit
of accounting.
At
September 30, 2006, the Company had the following three types of collaborative
contracts with the counterparties identified below:
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•
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License
to a single
target antigen (single-target
license):
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Biogen
Idec, Inc.
Biotest
AG
Boehringer
Ingelheim
International GmbH
Centocor, Inc.,
a
wholly-owned subsidiary of Johnson & Johnson
Genentech, Inc.
(multiple single-target licenses)
Millennium
Pharmaceuticals, Inc.
|
•
|
Broad
option
agreements to acquire rights to a limited number of targets over
a
specified time period (broad
license):
|
Amgen,
Inc. (formerly Abgenix, Inc.)
Genentech, Inc.
Millennium
Pharmaceuticals, Inc.
|
•
|
Broad
agreement to
discover, develop and commercialize antibody-based anticancer
products:
|
sanofi-aventis
Generally,
all of these
collaboration agreements provide that the Company will (i) at the
collaborator’s request, manufacture preclinical and clinical materials at the
Company’s cost, or, in some cases, cost plus a margin, (ii) receive
payments upon the collaborators’ achievements of certain milestones and
(iii) receive royalty payments, generally until the later of the last
applicable patent expiration or 12 years after product launch. The Company
is
required to provide technical training and any process improvements and know-how
to its collaborators during the term of the collaboration agreements.
Generally,
upfront payments on single-target licenses are deferred over the period of
the
Company's substantial involvement during development. ImmunoGen employees are
available to assist the Company's collaborators during the development of their
products. The Company estimates this development phase to begin at the inception
of the collaboration agreement and conclude at the end of non-pivotal Phase
II
testing. The Company believes this period of involvement is, on average and
depending on the nature of the license, six and one-half years. At each
reporting period, the Company analyzes individual product facts and
circumstances and reviews the estimated period of its substantial involvement
to
determine whether a significant change in its estimates has occurred and adjusts
the deferral period accordingly. As a result of a change in the estimated period
of substantial involvement during the three months ended September 30, 2006,
the
Company recognized approximately $13,000 of additional license and milestone
fees. This change in estimate had no impact in the loss per share for the three
months ended September 30, 2006. In the event that a single-target license
were
to be terminated, the Company would recognize as revenue any portion of the
upfront fee that had not previously been recorded as revenue, but was classified
as deferred revenue at the date of such termination.
The
Company defers upfront payments received from its broad licenses over the period
during which the collaborator may elect to receive a license. These periods
are
specific to each collaboration agreement, but are between seven and
12 years. If a collaborator selects an option to acquire a license under
these agreements, any option fee is deferred and recorded over the life of
the
option, generally 12 to 18 months. If a collaborator exercises an option
and the Company grants a single-target license to the collaborator, the Company
defers the license fee and accounts for the fee as it would an upfront payment
on a single-target license, as discussed above. Upon exercise of an option
to
acquire a license, the Company would recognize any remaining deferred option
fee
over the period of the Company’s substantial involvement under the license
acquired. In the event that a broad license agreement were to be terminated,
the
Company would recognize as revenue any portion of the upfront fee that had
not
previously been recorded as revenue, but was classified as deferred revenue
at
the date of such termination. In the event that a collaborator elects to
discontinue development of a specific product candidate under a single-target
license, but retains its right to use the Company's technology to develop an
alternative product candidate to the same target or a target substitute, the
Company would cease amortization of any remaining portion of the upfront fee
until there is substantial pre-clinical activity on another product candidate
and the Company’s remaining period of substantial involvement can be
estimated.
The
Company's discovery, development and commercialization agreement with
sanofi-aventis included an upfront payment of $12.0 million that
sanofi-aventis paid to ImmunoGen in August 2003. The Company deferred the
upfront payment and recognizes it ratably over the period of the Company's
substantial involvement of five years, which includes the term of the
collaborative research program of three years and two 12-month extensions that
sanofi-aventis has exercised. The discovery, development and commercialization
agreement also provides that ImmunoGen receive committed research funding
totaling $79.3 million over the full five years of the research collaboration,
which includes the initial three-year period and the two 12-month extensions.
The committed research funding is based upon resources that ImmunoGen is
required to contribute to the collaboration. The Company records the research
funding as it is earned based upon its actual resources utilized in the
collaboration. In August 2005, sanofi-aventis exercised the first of the two
12-month extensions. This extension will provide the Company with $18.2 million
in additional committed funding over the twelve months beginning September
1,
2006. In August
2006,
sanofi-aventis exercised its remaining option to extend the term of its research
collaboration with the Company for an additional year. The Company is to receive
a minimum of $10.4 million in committed research support funding from
sanofi-aventis over the twelve-month period beginning September 1, 2007.
At
the
conclusion of the second sanofi-aventis research program year on August 31,
2005, a review of research activities during this period was conducted. This
review identified $1.1 million in billable research activities performed under
the program during the fiscal year ended June 30, 2005, which had not been
billed or recorded as revenue. Accordingly, the Company has included this
additional $1.1 million of research and support revenue in the accompanying
consolidated statement of operations for the three months ended September 30,
2005. The Company does not believe such previously unrecorded revenue was
material to the results of operations or the financial position of the Company
for any interim period of 2005 or for the three months ended September 30,
2005.
When
milestone fees are specifically tied to a separate earnings process, revenue
is
recognized when the milestone is achieved. In addition, when appropriate, the
Company recognizes revenue from certain research payments based upon the level
of research services performed during the period of the research contract.
Deferred revenue represents amounts received under collaborative agreements
and
not yet earned pursuant to these policies. Where the Company has no continuing
involvement, the Company will record non-refundable license fees as revenue
upon
receipt and will record milestone revenue upon achievement of the milestone
by
the collaborative partner.
The
Company may produce preclinical and clinical materials for its collaborators.
The Company is reimbursed for its fully burdened cost to produce clinical
materials and, in some cases, fully burdened cost plus a profit margin. The
Company recognizes revenue on preclinical and clinical materials when the
materials have passed all quality testing required for collaborator acceptance
and title has transferred to the collaborator.
The
Company also produces research material for potential collaborators under
material transfer agreements. Additionally, research activities are
performed, including developing antibody-specific conjugation processes, on
behalf of the Company's collaborators and potential collaborators during the
early evaluation and preclinical testing stages of drug development. Generally,
the Company is reimbursed for its fully burdened cost of producing these
materials or providing these services. The Company records the amounts received
for the materials produced or services performed as a component of research
and
development support.
Marketable
Securities
The
Company invests in marketable securities of highly rated financial institutions
and investment-grade debt instruments and limits the amount of credit exposure
with any one entity. The Company has classified its marketable securities as
“available-for-sale” and, accordingly, carries such securities at aggregate fair
value. Unrealized gains and losses, if any, are reported as other comprehensive
income (loss) in stockholders’ equity. The amortized cost of debt securities in
this category is adjusted for amortization of premiums and accretion of
discounts to maturity. Such amortization and accretions are included in interest
income. Realized gains and losses on available-for-sale securities are included
in net realized losses on investments. The cost of securities sold is based
on
the specific identification method. Interest and dividends are included in
interest income.
Unbilled
Revenue
The
majority of the Company's unbilled revenue at September 30, 2006 and 2005
represents (i) committed research funding earned based on actual resources
utilized under the Company's discovery, development and commercialization
agreement with sanofi-aventis; (ii) reimbursable expenses incurred under
the Company's discovery, development and commercialization agreement with
sanofi-aventis that the Company has not yet invoiced; and (iii) research
funding earned based on actual resources utilized under the Company's
development and license agreements with Biogen Idec, Centocor and
Genentech.
Inventory
Inventory
costs primarily relate to clinical trial materials being manufactured for sale
to the Company’s collaborators. Inventory is stated at the lower of cost or
market as determined on a first-in, first-out (FIFO) basis.
Inventory
at September 30, 2006 and June 30, 2006 is summarized below (in
thousands):
|
|
September
30, 2006
|
|
June
30,
2006
|
|
|
|
|
|
Raw
materials
|
|
$
|
335
|
|
$
|
-
|
Work
in
process
|
|
|
1,585
|
|
|
1,235
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,920
|
|
$
|
1,235
|
Inventory
at September 30, 2006 and June 30, 2006 is stated net of write-downs of $2.5
million and $2.9 million as of, respectively. The write-downs represent the
cost
of DM1, DM4 and ansamitocin P3 that the Company considers to be in excess of
a
12-month supply based on current collaborator firm, fixed orders and
projections.
All
Tumor-Activated Prodrug (TAP) product candidates currently in preclinical and
clinical testing include either DM1 or DM4 as a cell-killing agent, and these
agents are the subject of the Company's collaborations. DM1 and DM4
(collectively referred to as DMx) are both manufactured from a precursor,
ansamitocin P3.
Due
to
yield fluctuations, the actual amount of ansamitocin P3 and DMx that will be
produced in future periods under supply agreements is highly uncertain. As
such,
the amount of ansamitocin P3 and/or DMx produced could be more than is
required
to
support
the development of the Company's and its collaborators' products. Such excess
product, as determined under the Company's inventory reserve policy, has been
charged to research and development expense to date.
The Company produces preclinical and clinical materials for its collaborators
either in anticipation of or in support of clinical trials, or for process
development and analytical purposes. Under the terms of supply agreements with
its collaborators, the Company generally receives rolling six month firm, fixed
orders for conjugate that the Company is required to manufacture, and rolling
12-month manufacturing projections for the quantity of conjugate the
collaborator expects to need in any given 12-month period. The amount of
clinical material produced is directly related to the number of on-going
clinical trials for which the Company is producing clinical material for itself
and its collaborators, the speed of enrollment in those trials and the dosage
schedule of each clinical trial. Because these elements are difficult to
estimate over the course of a trial, substantial differences between
collaborators' actual manufacturing orders and their projections could result
in
usage of DMx and ansamitocin P3 varying significantly from estimated usage
at an
earlier reporting period. To the extent that a collaborator has provided the
Company with a firm fixed order, the collaborator is contractually required
to
reimburse the Company the full cost of the conjugate and any agreed margin
thereon, even if the collaborator subsequently cancels the manufacturing
run.
The
Company accounts for the DMx and ansamitocin P3 inventory as
follows:
|
a)
|
That
portion of the DMx and/or ansamitocin P3 that the Company intends
to use
in the production of its own products is expensed upon receipt of
the
materials;
|
|
b)
|
To
the extent that the Company has collaborator projections for up to
12 months of firm, fixed orders and/or projections, the Company
capitalizes the value of DMx and ansamitocin P3 that will be used
in the
production of conjugate subject to these firm, fixed orders and/or
projections;
|
|
c)
|
The
Company considers more than a 12-month supply of ansamitocin P3 and/or
DMx
that is not supported by collaborators' firm, fixed orders or projections
to be excess. The Company establishes a reserve to reduce to zero
the
value of any such excess ansamitocin P3 or DMx inventory with a
corresponding charge to cost of clinical materials reimbursement
expense;
and
|
|
d)
|
The
Company also considers any other external factors and information
of which
it becomes aware and assesses the impact of such factors or information
on
the net realizable value of the DMx and ansamitocin P3 inventory
at each
reporting period.
|
The
Company did not record any cost of clinical materials reimbursement expense
related to excess inventory during the three months ended September 30, 2006.
However, in the three months ended September 30, 2005, the Company recorded
$127,000 to write down certain batches of ansamitocin P3 and DMx and certain
work-in-process amounts to their net realizable value. If the Company increases
its on-hand supply of DMx or ansamitocin P3, a corresponding change to the
Company's collaborators' projections could result in significant changes in
the
Company's estimate of the net realizable value of DMx and ansamitocin P3
inventory. Reductions in collaborators' projections could indicate that the
Company has additional excess DMx and/or ansamitocin P3 inventory and the
Company would then evaluate the need to record further write-downs,
included as charges to cost of clinical materials
reimbursement.
Computation
of Net
Loss Per Common Share
Basic
net
loss per common share is calculated based upon the weighted average number
of
common shares outstanding during the period. Diluted net loss per common share
incorporates the dilutive effect of stock options and warrants. The total number
of options and warrants convertible into ImmunoGen Common Stock and the
resulting ImmunoGen Common Stock equivalents, as calculated in accordance with
the treasury-stock accounting method, are included in the following table (in
thousands):
|
|
Three
Months
Ended
September
30,
|
|
|
2006
|
|
2005
|
|
|
|
Options
and warrants
convertible into Common Stock
|
|
|
5,863
|
|
|
6,092
|
|
|
|
|
|
|
|
Common
Stock
equivalents
|
|
|
711
|
|
|
1,886
|
ImmunoGen
Common Stock equivalents have not been included in the calculations of dilutive
net loss per common share calculations for the three months ended September
30,
2006 and 2005 because their effect is anti-dilutive due to the Company’s net
loss position.
Comprehensive
Loss
The
Company presents comprehensive income (loss) in accordance with Statement of
Financial Accounting Standards (SFAS) No. 130, “Reporting Comprehensive
Income.” For the three months ended September 30, 2006 and 2005, total
comprehensive loss equaled $6.0 million and $4.7 million,
respectively. Comprehensive loss was comprised entirely of the Company’s
net loss and the change in its unrealized gains and losses on its
available-for-sale marketable securities for all periods presented.
Stock-Based
Compensation
As
of
September 30, 2006, the Company has one share-based compensation plan, which
is
the ImmunoGen, Inc. Restated Stock Option Plan. The Company’s Restated Stock
Option Plan as amended, or the Plan, which is shareholder-approved, permits
the
grant of share options to its employees, consultants and directors for up to
8.55 million shares of common stock. Option awards are granted with an exercise
price equal to the market price of the Company’s stock at the date of grant.
Options vest at various periods of up to four years and may be exercised within
ten years of the date of grant.
Effective
July 1, 2005, the Company adopted the fair value recognition provisions of
Financial Accounting Standards Board (FASB) Statement 123(R), Share-Based
Payment (Statement
123(R)), using the modified-prospective-transition method. Under that transition
method, compensation cost recognized includes: (a) compensation cost for all
share-based payments granted, but not yet vested as of July 1, 2005, based
on
the grant-date fair value estimated in accordance with the original provisions
of Statement 123 (as defined below), and (b) compensation cost for all
share-based payments granted subsequent to July 1, 2005, based on the grant-date
fair value estimated in accordance with the provisions of Statement
123(R). Such amounts have been reduced by the Company’s estimate of
forfeitures of all unvested awards. Prior to July 1, 2005, the Company accounted
for its stock-based compensation plans under the recognition and measurement
provisions of Accounting Principles Board Opinion No. 25, “Accounting for
Stock Issued to Employees” (APB 25), and related interpretations for all awards
granted to employees. Under APB 25, when the exercise price of options granted
to employees under these plans equals the market price of the common stock
on
the date of grant, no compensation expense is recorded. When the exercise
price of options granted to employees under these plans is less than the market
price of the common stock on the date of grant, compensation expense is
recognized over the vesting period. Results for prior periods have not been
restated. For stock options granted to non-employees, the Company recognizes
compensation expense in accordance with the requirements of Statement of
Financial Accounting Standards (SFAS) No. 123, “Accounting for Stock Based
Compensation” (Statement 123). Statement 123 requires that companies
recognize compensation expense based on the estimated fair value of options
granted to non-employees over their vesting period, which is generally the
period during which services are rendered by such non-employees.
As
a
result of adopting Statement 123(R) on July 1, 2005, the Company’s net loss for
the three months ended September 30, 2006 and 2005 was $583,000 and $610,000,
respectively, or $0.01 per share for both periods, greater than if it had
continued to account for share-based compensation under APB 25.
The
fair
value of each stock option is estimated on the date of grant using the
Black-Scholes option-pricing model that uses the assumptions noted in the
following table. Expected volatility is based exclusively on historical
volatility data of the Company’s stock. The expected term of stock options
granted is based exclusively on historical data and represents the period of
time that stock options granted are expected to be outstanding. The expected
term is calculated for and applied to one group of stock options as the Company
does not expect substantially different exercise or post-vesting termination
behavior among its employee population. The risk-free rate of the stock options
is based on the US Treasury rate in effect at the time of grant for the expected
term of the stock options.
|
|
Three
Months
Ended September 30,
|
|
|
2006
|
|
2005
|
|
|
|
|
|
Dividend
Yield
|
|
|
None
|
|
|
None
|
Volatility
|
|
|
84.86%
|
|
|
89.38%
|
Risk-free
interest
rate
|
|
|
5.01%
|
|
|
3.99%
|
Expected
life
(years)
|
|
|
6.7
|
|
|
5.9
|
Using
the
Black-Scholes option-pricing model, the weighted average grant date fair value
of options granted during the three months ended September 30, 2006 and 2005
was
$2.37 and 4.96, respectively.
As
of
September 30, 2006, the estimated fair value of unvested employee awards was
$4.6 million net of estimated forfeitures. The weighted-average remaining
vesting period for these awards is approximately two years.
During
the three months ended September 30, 2006, holders of options issued under
the
Plan exercised their rights to acquire an aggregate of 11,250 shares of common
stock at a price of $2.30 per share. The total proceeds to the Company
from these option exercises were approximately $26,000.
Reclassifications
Certain
prior year balances have been reclassified to conform to current year
presentation.
Segment
Information
During
the three months ended September 30, 2006, the Company continued to operate
in
one reportable business segment under the management approach of SFAS
No. 131, “Disclosures about Segments of an Enterprise and Related
Information,” which is the business of discovery of monoclonal antibody-based
cancer therapeutics.
Revenues
from sanofi-aventis accounted for approximately 67% and 79% of total revenues
for the three months ended September 30, 2006 and 2005,
respectively. Revenues from Genentech accounted for 24% and 10% of total
revenues for the three months ended September 30, 2006 and 2005, respectively.
There were no other significant individual customers in the three months ended
September 30, 2006 and 2005.
B. Agreements
Biotest
AG
In
July
2006, the Company entered into a
development and license agreement with Biotest AG. The agreement grants Biotest
AG exclusive rights to use the Company’s TAP technology with antibodies to a
target found on multiple myeloma cells to create anticancer therapeutics. Under
the agreement, the Company has received a $1 million upfront payment,
and
is
entitled to receive up to $35.5 million in milestone payments and royalties
on
the sales of any resulting products.
The
Company will receive manufacturing payments for any preclinical and clinical
materials made at the request of Biotest. The agreement also provides ImmunoGen
with the right to elect to participate, at specific stages during the clinical
evaluation of any compound created under this agreement, in the US development
and commercialization of that compound in lieu of receiving royalties on US
sales of that product and the milestone payments not yet earned. The Company
can
exercise this right by payment to Biotest of an agreed-upon fee of $5 million
or
$15 million, depending on the stage of development. Upon exercise of this right,
ImmunoGen and Biotest would share equally the associated costs of product
development and commercialization in the US along with the profit, if any,
from
US product sales.
sanofi-aventis
In
August
2006, sanofi-aventis
exercised
its remaining option to extend the term of the research collaboration with
the
Company for another year, and committed to pay the Company a minimum of $10.4
million in research support over the twelve months beginning September 1, 2007.
Additionally, effective September 1, 2006, ImmunoGen is no longer obligated
to
present new targets for antibody-based anticancer therapeutics to
sanofi-aventis, enabling the Company to use such targets in the development
of
its own proprietary products. After August 2008, sanofi-aventis will need to
license the right to use ImmunoGen’s maytansinoid TAP technology with antibodies
to targets that were not part of the research collaboration between the Company
and sanofi-aventis. The Companies have agreed to negotiate a multi-target
agreement to provide sanofi-aventis with access to the Company’s TAP technology
for such antibody targets.
The
Company has agreements with other companies with respect to its compounds,
as
described elsewhere in this Quarterly Report and in its 2006 Annual Report
on
Form 10-K.
C. Capital
Stock
The
Company recorded approximately $10,000 and $37,000 in compensation expense
during the three months ended September 30, 2006 and 2005, respectively, related
to stock units outstanding under the Company’s 2001 Non-Employee Director Stock
Plan. The value of the stock units is adjusted to market value at each reporting
period.
Under
the
Company’s 2004 Non-Employee Director Compensation and Deferred Share Unit Plan,
the Company issued 35,047 and 13,817 deferred share units during the three
months ended September 30, 2006 and 2005, respectively. The Company recorded
approximately $54,000 and $56,000 in compensation expense related to deferred
share units outstanding under the 2004 Plan during the three months ended
September 30, 2006 and 2005. The value of the share units is adjusted to market
value at each reporting period.
D. Subsequent
Event
In
October 2006, sanofi-aventis informed the Company that clinical testing of
AVE1642 had begun, triggering a $2 million milestone payment to the Company.
This milestone will be included in license and milestone fees revenue for the
period ending December 31, 2006. Additionally, in October 2006, sanofi-aventis
licensed non-exclusive rights to use ImmunoGen’s proprietary resurfacing
technology to humanize antibodies. This technology was developed to enable
antibodies initially of murine origin to appear to be human to the human immune
system. This license provides sanofi-aventis with the non-exclusive right to
use
ImmunoGen’s proprietary humanization technology through August 31, 2011,
and can be extended thereafter. Under the terms of the license, ImmunoGen will
receive a $1 million license fee, half of which is due within 30 days of
contract signing, and in addition, ImmunoGen is entitled to receive milestone
payments potentially totaling $4.5 million plus royalties on sales for each
compound humanized under this agreement.
ITEM
2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
OVERVIEW
Since
the
Company's inception, we have been principally engaged in the development of
antibody-based anticancer therapeutics. The combination of our expertise in
antibodies and cancer biology has resulted in the development of both
proprietary product candidates and technologies. Our proprietary
Tumor-Activated Prodrug, or TAP, technology combines extremely potent small
molecule cytotoxic agents with monoclonal antibodies that bind specifically
to
cancer cells. Our TAP technology is designed to increase the potency of
tumor-targeting antibodies and kill cancer cells with only modest damage to
healthy tissue. The cytotoxic agents we use in our TAP compounds currently
in
preclinical and clinical testing are DM1 and DM4, chemical derivatives of a
naturally occurring substance called maytansine. We also use our expertise
in
antibodies and cancer to develop other types of therapeutics, such as
naked-antibody anticancer product candidates.
We
have
entered into collaborative agreements that enable companies to use our TAP
technology to develop commercial product candidates containing their antibodies.
We have also used our proprietary TAP technology in conjunction with our
in-house antibody expertise to develop our own anticancer product
candidates. Under the terms of our collaborative agreements, we are
entitled to upfront fees, milestone payments, and royalties on any commercial
product sales. We are reimbursed for our fully burdened costs to
manufacture preclinical and clinical materials and, under certain collaborative
agreements, the reimbursement includes a profit margin. Currently, our
collaborative partners include Amgen, Inc. (formerly Abgenix, Inc.), Biogen
Idec, Biotest AG, Boehringer Ingelheim International GmbH, Centocor, Inc.
(a wholly-owned subsidiary of Johnson & Johnson), Genentech, Inc.,
Millennium Pharmaceuticals, Inc., and sanofi-aventis. We expect that
substantially all of our revenue for the foreseeable future will result from
payments under our collaborative arrangements.
In
July 2003, we announced a discovery, development and commercialization
collaboration with Aventis Pharmaceuticals, Inc. (now
sanofi-aventis). Under the terms of this agreement, in consideration
of an upfront payment of $12 million, sanofi-aventis gained commercialization
rights to three of the then most advanced product candidates in our preclinical
pipeline and the commercialization rights to new product candidates developed
within the collaboration during its research portion. This collaboration allows
us to benefit from sanofi-aventis' clinical development and commercialization
capabilities. Under the terms of the sanofi-aventis agreement, we also are
entitled to receive committed research funding totaling approximately
$79.3 million over the full five years of the research collaboration, which
includes the initial three-year term of the research program ending August
31,
2006 plus the two 12-month extensions beginning September 1, 2006.
In
August
2005, sanofi-aventis exercised its contractual right to extend the term of
its
research program with us and committed to fund $18.2 million in research support
over the twelve months beginning September 1, 2006. In August 2006, sanofi-aventis
exercised
its remaining option to extend the term of the research collaboration with
us
for an additional year, and committed to pay ImmunoGen a minimum of $10.4
million in research support over the twelve months beginning September 1, 2007.
Additionally, effective September 1, 2006, we are no longer obligated to present
new targets for antibody-based anticancer therapeutics to sanofi-aventis,
enabling us to be able to use such targets in the development of our own
proprietary products. After August 2008, sanofi-aventis will need to license
the
right to use our maytansinoid TAP technology with antibodies to targets that
were not part of the research collaboration between us and sanofi-aventis.
ImmunoGen and sanofi-aventis have agreed to negotiate a multi-target agreement
to provide sanofi-aventis with access to our TAP technology for such antibody
targets.
On
January
27, 2006, Genentech notified us that the trastuzumab-DM1 Investigational New
Drug (IND) application submitted by Genentech to the FDA had become effective.
Under the terms of our May 2000 exclusive license agreement with Genentech
for
antibodies to HER2, this event triggered a $2.0 million milestone payment to
us.
On
January
25, 2006, Millennium Pharmaceuticals, Inc. notified us that, as part of its
ongoing portfolio management process and based on the evaluation of recent
clinical data in the context of other opportunities in its pipeline, Millennium
had decided not to continue the development of its MLN2704 compound. Millennium
retains its right to use our maytansinoid TAP technology with antibodies
targeting PSMA.
On
March
27, 2006, Millennium extended the agreement that provides Millennium with
certain rights to test our TAP technology with antibodies to specific targets
and to license the right to use the technology to develop products on the terms
defined in the agreement. This agreement was scheduled to expire on March 30,
2006 unless extended by Millennium. It is now scheduled to expire on
March 30, 2007. In consideration for this extension, Millennium paid us an
extension fee equal to $250,000.
In
August 2003, Vernalis completed its acquisition of British Biotech. In
connection with this acquisition, the merged company, called Vernalis plc,
announced that it intended to review its merged product candidate portfolio,
including its collaboration with ImmunoGen on huN901-DM1. After discussion
with
Vernalis, in January 2004 we announced that we would take over
further
development
of the product candidate. Pursuant to the terms of the termination agreement
executed on January 7, 2004, Vernalis retained responsibility for the
conduct and expense of the study it initiated in the US (Study 001) until June
30, 2004, and the study it had started in the United Kingdom (Study 002) through
completion. We took over responsibility for Study 001 on July 1, 2004 and,
in
September 2005, we announced the initiation of our own clinical trial with
huN901-DM1 in multiple myeloma (Study 003). On December 15, 2005, we executed
an
agreement to amend the residual obligation terms of the January 7, 2004
termination agreement with Vernalis. Under the terms of the amendment, we
assumed responsibility for Study 002 as of December 15, 2005, including the
cost
of its completion. Under the amendment, Vernalis paid us $365,000 in
consideration of the expected cost of the obligations assumed by us with
the amendment. New clinical
data will be
reported from the Company’s ongoing Study 002 on November 10, 2006 at the
18th
EORTC-NCI-AACR
International Conference on Molecular Targets and Cancer Therapeutics (EORTC)
in
Prague.
On January 8, 2004, we announced that we intended to advance cantuzumab
mertansine, or an improved version of the compound, into human testing to assess
the clinical utility of the compound in certain indications. In
October 2004, we announced that we decided to move huC242-DM4 into clinical
trials instead of cantuzumab mertansine (huC242-DM1). We initiated a Phase
I
clinical trial with huC242-DM4 in June 2005 and expect to report the first
data from this trial at the EORTC conference
on
November 8, 2006.
Based
upon
the results of our clinical trials, if and when they are completed, we will
evaluate whether to continue clinical development of huN901-DM1 and huC242-DM4,
and, if so, whether we will seek a collaborative partner or partners to continue
the clinical development and commercialization of either or both of these
compounds.
To
date,
we have not generated revenues from commercial product sales and we expect
to
incur significant operating losses for the foreseeable future. We do not
anticipate that we will have a commercially approved product within the near
future. Research and development expenses and cash expenditures are expected
to
increase significantly in the near term as we continue our development efforts,
including an expanded clinical trial program and development of commercial-grade
materials. As of September 30, 2006, we had approximately $70.3 million in
cash
and marketable securities. We anticipate that our current capital resources
and
future collaboration payments, including the committed research funding due
us
under the sanofi-aventis collaboration over the remainder of the research
program, will enable us to meet our operational expenses and capital
expenditures for at least the current and next one to two fiscal
years.
We
anticipate that the increase in total cash expenditures will be partially offset
by collaboration-derived proceeds, including milestone payments and the
committed research funding to which we are entitled pursuant to the
sanofi-aventis collaboration. Accordingly, period-to-period operational results
may fluctuate dramatically based upon the timing of receipt of the proceeds.
We
believe that our established collaborative agreements, while subject to
specified milestone achievements, will provide funding to assist us in meeting
obligations under our collaborative agreements while also assisting in providing
funding for the development of internal product candidates and
technologies. However, we can give no assurances that such collaborative
agreement funding will, in fact, be realized in the time frames we expect,
or at
all. Should we or our partners not meet some or all of the terms and conditions
of our various collaboration agreements, we may be required to pursue additional
strategic partners, secure alternative financing arrangements, and/or defer
or
limit some or all of our research, development and/or clinical
projects.
Critical
Accounting
Policies
We
prepare
our consolidated financial statements in accordance with accounting principles
generally accepted in the US. The preparation of these financial statements
requires us to make estimates and judgments that affect the reported amounts
of
assets, liabilities, revenues and expenses and related disclosure of contingent
assets and liabilities. On an on-going basis, we evaluate our estimates,
including those related to our collaborative agreements and inventory. We base
our estimates on historical experience and various other assumptions that we
believe to be reasonable under the circumstances. Actual results may differ
from
these estimates.
We
believe
the following critical accounting policies affect our more significant judgments
and estimates used in the preparation of our consolidated financial
statements.
Revenue
Recognition
We
estimate the period of our significant involvement during development for each
of our collaborative agreements. We recognize any upfront fees received from
our
collaborators ratably over this estimated period of significant involvement.
We
generally believe our period of significant involvement occurs between the
date
we sign a collaboration agreement and completion of non-pivotal Phase II testing
of our collaborator’s product that is the subject of the collaboration
agreement. We estimate that this time period is generally six and one-half
years, depending on the characteristics of the license. The actual period of
our
involvement could differ significantly based upon the results of our
collaborators’ preclinical and clinical trials, competitive products that are
introduced into the market and the general uncertainties surrounding drug
development. Any difference between our estimated period of involvement during
development and our actual period of involvement could have a material effect
upon our results of operations. We assess our period of significant involvement
with each collaboration on a quarterly basis and adjust the period of
involvement prospectively, as appropriate.
We
recognize the $12.0 million upfront fee we received from sanofi-aventis ratably
over our estimated period of significant involvement of five years. This
estimated period includes the initial three-year term of the collaborative
research program and the two 12-month extensions sanofi-aventis exercised in
August 2005 and 2006.
Inventory
We
review
our estimates of the net realizable value of our inventory at each reporting
period. Our estimate of the net realizable value of our inventory is
subject to judgment and estimation. The actual net realizable value of our
inventory could vary significantly from our estimates. We consider
quantities of DM1 and DM4, collectively referred to as DMx, and ansamitocin
P3
in excess of 12 month projected usage that is not supported by collaborators'
firm, fixed orders and projections to be excess. To date, we have fully reserved
any such material identified as excess with a corresponding charge to cost
of
clinical materials. Our collaborators' estimates of their clinical material
requirements are based upon expectations of their clinical trials, including
the
timing, size, dosing schedule and maximum tolerated dose of each clinical
trial. Our collaborators' actual requirements for clinical materials may vary
significantly from their projections. Sizeable differences between our
collaborators' actual manufacturing orders and their projections could result
in
our actual 12-month usage of DMx and ansamitocin P3 varying significantly from
our estimated usage at an earlier reporting period.
Stock
Based Compensation
As
of
September 30, 2006, the Company has one share-based compensation plan, which
is
the ImmunoGen, Inc. Restated Stock Option Plan. Effective July 1, 2005, we
adopted the fair value recognition provisions of Financial Accounting Standards
Board (FASB) Statement 123(R), Share-Based
Payment (Statement
123(R)), using the modified-prospective-transition method. Under that transition
method, compensation cost includes: (a) compensation cost for all share-based
payments granted, but not yet vested as of July 1, 2005, based on the grant-date
fair value estimated in accordance with the original provisions of Statement
123
(as defined below), and (b) compensation cost for all share-based payments
granted subsequent to July 1, 2005, based on the grant-date fair value estimated
in accordance with the provisions of Statement 123(R). Such amounts have
been reduced by the Company’s estimate of forfeitures of all unvested awards.
The
fair
value of each stock option is estimated on the date of grant using the
Black-Scholes option-pricing model. Expected volatility is based exclusively
on
historical volatility data of the Company’s stock. The expected term of stock
options granted is based exclusively on historical data and represents the
period of time that stock options granted are expected to be outstanding. The
expected term is calculated for and applied to one group of stock options as
the
Company does not expect substantially different exercise or post-vesting
termination behavior among its employee population. The risk-free rate of
the stock options is based on the US Treasury rate in effect at the time of
grant for the expected term of the stock options. The compensation cost that
has
been incurred during the three months ended September 30, 2006 is $583,000.
As
of September 30, 2006, the estimated fair value of unvested employee awards
was
$4.6 million net of estimated forfeitures. The weighted-average remaining
vesting period for these awards is approximately two years.
RESULTS
OF
OPERATIONS
Comparison
of
Three Months ended September 30, 2006 and 2005
Our
total
revenues for each of the three months ended September 30, 2006 and 2005
were both $7.8 million. While
revenues in the
quarter ended September 30, 2006 were essentially unchanged from the same period
in the prior fiscal year, lower
research and development support revenue was partially offset by higher license
and milestone fees, and to a lesser extent, clinical materials reimbursement
revenue.
Research
and development support was $5.5 million for the three months ended September
30, 2006 compared with $5.7 million for the three months ended September 30,
2005. These amounts primarily represent committed research funding earned based
on actual resources utilized under our discovery, development and
commercialization agreement with sanofi-aventis, as well as amounts earned
for
resources utilized under our development and license agreements with Biogen
Idec, Centocor, and Genentech. Of the $5.7 million reported in the first quarter
of fiscal 2006, $1.1 million represents funding related to research and
development efforts performed during the Company’s 2005 fiscal year under the
sanofi-aventis collaboration but billed and recognized in fiscal 2006. Also
included in research and development support revenue are fees related to samples
of research-grade material shipped to collaborators. To date, our development
fees represent the fully burdened reimbursement of costs incurred in producing
research-grade materials and developing antibody-specific conjugation processes
on behalf of our collaborators and potential collaborators during the early
evaluation and preclinical testing stages of drug development. The amount of
development fees we earn is directly related to the number of our collaborators
and potential collaborators, the stage of development of our collaborators’
compounds and the resources our collaborators allocate to the development
effort. As such, the amount of development fees may vary widely from quarter
to
quarter and year to year.
Revenues
from license and milestone fees for the three months ended September 30, 2006
increased $145,000 to $1.4 million from $1.3 million in the same period ended
September 30, 2005. Total revenue from license and milestone fees
recognized from each of our collaborative partners in the three-month periods
ended September 30, 2006 and 2005 is included in the following table (in
thousands):
|
|
Three
months
ended September 30,
|
|
|
2006
|
|
2005
|
Collaborative
Partner:
|
|
|
|
|
Amgen
(formerly
Abgenix)
|
|
$
|
100
|
|
$
|
100
|
Sanofi-aventis
|
|
|
600
|
|
|
600
|
Biogen
Idec
|
|
|
22
|
|
|
12
|
Biotest
|
|
|
38
|
|
|
-
|
Centocor
|
|
|
38
|
|
|
42
|
Genentech
|
|
|
390
|
|
|
397
|
Millennium
|
|
|
218
|
|
|
110
|
Total
|
|
$
|
1,406
|
|
$
|
1,261
|
Deferred
revenue of $16.2 million as of September 30, 2006 primarily represents payments
received from our collaborators pursuant to our license and supply agreements,
which we have yet to earn pursuant to our revenue recognition
policy.
Clinical
materials reimbursement increased by approximately $26,000 to $857,000 in the
three months ended September 30, 2006, compared to $831,000 in the three months
ended September 30, 2005. During
the three months
ended September 30, 2006, we shipped clinical materials in support of the
AVE9633 clinical trials and trastuzumab-DM1 clinical trials, as well as
preclinical materials in support of the development efforts of certain other
collaborators.
During
the three months ended September 30, 2005, we shipped clinical materials in
support of the AVE9633 clinical trials, as well as preclinical materials in
support of the development efforts of certain other collaborators. Under certain
collaborative agreements, we are reimbursed for our fully burdened cost to
produce clinical materials plus a profit margin. The amount of clinical
materials reimbursement we earn, and the related cost of clinical materials
reimbursed, is directly related to (i) the number of on-going clinical
trials our collaborators have underway, the speed of enrollment in those trials,
the dosage schedule of each clinical trial and the time period, if any, during
which patients in the trial receive clinical benefit from the clinical
materials, and (ii) our production of clinical-grade material on behalf of
our collaborators, either in anticipation of clinical trials, or for process
development and analytical purposes. As such, the amount of clinical materials
reimbursement and the related cost of clinical materials reimbursed may vary
significantly from quarter to quarter and year to year.
Research
and
Development Expenses
We
report
research and development expense net of certain reimbursements we receive from
our collaborators. Our net research and development expenses relate to
(i) research to identify and evaluate new targets and to develop and
evaluate new antibodies and cytotoxic drugs, (ii) preclinical testing of
our own and, in certain instances, our collaborators' product candidates, and
the cost of our own clinical trials, (iii) development related to clinical
and commercial manufacturing processes and (iv) manufacturing operations.
Our research and development efforts have been primarily focused in the
following areas:
|
§
|
activities
pursuant to our discovery, development and commercialization agreement
with sanofi-aventis;
|
|
§
|
activities
related to the preclinical and clinical development of huN901-DM1
and
huC242-DM4;
|
|
§
|
process
development related to production of the huN901 antibody and huN901-DM1
conjugate for clinical materials;
|
|
§
|
process
development related to production of the huC242 antibody and huC242-DM4
conjugate for clinical materials;
|
|
§
|
process
improvements related to the production of DM1, DM4 and strain development
of their precursor, ansamitocin P3;
|
|
§
|
funded
development activities with contract manufacturers for the huN901
antibody, the huC242 antibody, and DM1, DM4 and their precursor,
ansamitocin P3;
|
|
§
|
operation
and maintenance of our conjugate manufacturing
plant;
|
|
§
|
process
improvements to our TAP technology;
|
|
§
|
identification
and evaluation of potential antigen
targets;
|
|
§
|
evaluation
of internally developed and in-licensed antibody candidates;
and
|
|
§
|
development
and evaluation of additional cytotoxic
agents.
|
DM1
and
DM4 are the cytotoxic agents that we currently use in the
manufacture of our two TAP product candidates in clinical testing. We have
also investigated the viability of other maytansinoid effector molecules, which,
collectively with DM1 and DM4, we refer to as DMx. In order to make commercial
manufacture of DMx conjugates viable, we have devoted substantial resources
to
improving the strain of the microorganism that produces ansamitocin P3, the
precursor to DMx, to enhance manufacturing yields. We also continue to devote
considerable resources to improve other DMx manufacturing
processes.
On
January 8, 2004, we announced that pursuant to the terms and conditions of
a termination agreement between us and Vernalis, Vernalis relinquished its
rights to develop and commercialize huN901-DM1. As a result, we regained the
rights to develop and commercialize huN901-DM1. Under the terms of this
termination agreement with Vernalis, we assumed responsibility for one of the
studies underway with the compound (Study 001) on July 1, 2004. Since then,
we have expanded this study based upon the data from the initial patients
enrolled. Additionally, we initiated a Phase I clinical trial with huN901-DM1
in
CD56-positive multiple myeloma (Study 003) in September 2005. On December 15,
2005, we executed an amendment to this termination agreement with Vernalis.
Under the terms of the amendment, we assumed responsibility as of December
15,
2005, at our own expense, to complete the huN901-DM1 clinical study (Study
002)
that had been initiated in the United Kingdom. Vernalis paid us $365,000 in
consideration of the expected cost of the obligations assumed by us under
the amendment. We intend to evaluate whether to out-license all or part of
the
development and commercial rights to this compound as we move through the
clinical trial process.
In
January 2004, we announced that we planned to advance cantuzumab
mertansine, or an improved version of the compound, into a clinical trial that
we would manage. In October 2004, we decided to move forward in developing
a modified version of cantuzumab mertansine which we call huC242-DM4. Patient
dosing was initiated for the Phase I study of huC242-DM4 in June 2005. We
intend to evaluate whether to out-license all or part of the development and
commercial rights to this compound as we move through the clinical trial process
for this compound. New compounds created during the collaboration were also
licensed to sanofi-aventis.
In
July
2003, we licensed the three then-most advanced product candidates in our
preclinical portfolio to sanofi-aventis under the terms of our discovery,
development and commercialization collaboration. These three product candidates
were an anti-CD33 TAP compound for acute myeloid leukemia (AVE9633), an
anti-IGF-1R antibody (AVE1642), and an anti-CD19 TAP compound (SAR 3419) for
certain B-cell malignancies, including non-Hodgkin’s lymphoma.
Clinical
testing of AVE9633 was initiated in March 2005. In October 2006, clinical
testing of AVE1642, a therapeutic antibody that binds to the Insulin-like Growth
Factor 1 Receptor (IGF-1R), was initiated. SAR 3419 is in preclinical
development. Additional compounds also are in various stages of
development.
Our
agreement with sanofi-aventis required us to present for inclusion in the
collaborative research program certain antibodies or antibody targets that
we
believe will have utility in oncology, with the exception of those antibodies
or
antibody targets that are the subject of our preexisting or future collaboration
and license agreements. Sanofi-aventis then had the right to either include
in
or exclude from the collaborative research program these proposed antibodies
and
antibody targets. If sanofi-aventis elected to exclude any antibodies or
antibody targets, we could elect to develop the compounds for our own pipeline.
Effective
September 1, 2006, we are no longer obligated to present new targets for
antibody-based anticancer therapeutics to sanofi-aventis, enabling us to use
such targets in the development of our own proprietary products. Over
the
original, three-year term of the research program and two agreed-upon one-year
extensions, we will receive a minimum of $79.3 million of committed
research funding and will devote a significant amount of our internal research
and development resources to advancing the research program. Under the terms
of
the agreement, we may advance any TAP or antibody products that sanofi-aventis
has elected not to either initially include or later advance in the research
program. After August
2008,
sanofi-aventis will need to license the right to use our maytansinoid TAP
technology with antibodies to targets that were not part of our research
collaboration. Sanofi-aventis and ImmunoGen have agreed to negotiate a
multi-target agreement to provide sanofi-aventis with access to our maytansinoid
TAP technology for such antibody targets.
The
potential product candidates that have been or that may eventually be excluded
from the sanofi-aventis collaboration are in an early stage of discovery
research and we are unable to accurately estimate which potential products,
if
any, will eventually move into our internal preclinical research program. We
are
unable to reliably estimate the costs to develop these products as a result
of
the uncertainties related to discovery research efforts as well as preclinical
and clinical testing. Our decision to move a product candidate into the clinical
development phase is predicated upon the results of preclinical tests. We cannot
accurately predict which, if any, of the discovery research stage product
candidates will advance from preclinical testing and move into our internal
clinical development program. The clinical trial and regulatory approval
processes for our product candidates that have advanced or we intend to advance
to clinical testing are lengthy, expensive and uncertain in both timing and
outcome. As a result, the pace and timing of the clinical development of our
product candidates is highly uncertain and may not ever result in approved
products. Completion dates and development costs will vary significantly for
each product candidate and are difficult to predict. A variety of factors,
many
of which are outside our control, could cause or contribute to the prevention
or
delay of the successful completion of our clinical trials, or delay or prevent
our obtaining necessary regulatory approvals. The costs to take a product
through clinical trials are dependent upon, among other factors, the clinical
indications, the timing, size and dosing schedule of each clinical trial, the
number of patients enrolled in each trial, and the speed at which patients
are
enrolled and treated. Product candidates may be found ineffective or cause
harmful side effects during clinical trials, may take longer to progress through
clinical trials than anticipated, may fail to receive necessary regulatory
approvals or may prove impracticable to manufacture in commercial quantities
at
reasonable cost or with acceptable quality.
The
lengthy process of securing FDA approvals for new drugs requires the expenditure
of substantial resources. Any failure by us to obtain, or any delay in
obtaining, regulatory approvals would materially adversely affect our product
development efforts and our business overall. Accordingly, we cannot currently
estimate, with any degree of certainty, the amount of time or money that we
will
be required to expend in the future on our product candidates prior to their
regulatory approval, if such approval is ever granted. As a result of these
uncertainties surrounding the timing and outcome of our clinical trials, we
are
currently unable to estimate when, if ever, our product candidates that have
advanced into clinical testing will generate revenues and cash
flows.
Research
and development expense for the three months ended September 30, 2006 increased
$1.9 million to $11.4 million from $9.5 million for the three months ended
September 30, 2005. The number
of research and
development personnel increased to 152 at September 30, 2006 compared to 144
at
September 30, 2005. Research and development salaries and related expenses
increased by $479,000 in the three months ended September 30, 2006 compared
to
the three months ended September 30, 2005. Included in salaries and related
expenses for the three months ended September 30, 2006 and 2005 is $347,000
and
$352,000, respectively, of stock compensation costs incurred with the adoption
of SFAS 123(R) on July 1, 2005. Contract service expense increased by $1.9
million in the three months ended September 30, 2006 compared to the same period
ended September 30, 2005. This increase is primarily related to the
manufacturing and process development activity related to our compounds in
clinical trials. Partially offsetting these increases, overhead utilization,
which are expenses charged to clinical materials reimbursement, increased by
$806,000 in the three months ended September 30, 2006 compared to the three
months ended September 30, 2005.
We
expect
future research and development expenses to increase as we expand our clinical
trial activity. We do not track our research and development costs by project.
Since we use our research and development resources across multiple research
and
development projects, we manage our research and development expenses within
each of the categories listed in the following table and described in more
detail below (in thousands):
|
|
Three
Months
Ended September 30,
|
|
|
2006
|
|
2005
|
|
|
|
Research
|
|
$
|
3,674
|
|
$
|
3,509
|
Preclinical
and
Clinical Testing
|
|
|
1,927
|
|
|
1,690
|
Process
and Product
Development
|
|
|
1,311
|
|
|
1,370
|
Manufacturing
Operations
|
|
|
4,504
|
|
|
2,923
|
|
|
|
|
|
|
|
Total
Research and
Development Expense
|
|
$
|
11,416
|
|
$
|
9,492
|
Research:
Research includes expenses associated with activities to identify and evaluate
new targets and to develop and evaluate new antibodies and cytotoxic agents
for
our products and in support of our collaborators. Such expenses primarily
include personnel, fees to in-license certain technology, facilities and lab
supplies. Research
expenses for the
three months ended September 30, 2006 increased $165,000 to $3.7 million from
$3.5 million for the three months ended September 30, 2005. The increase in
research expenses was primarily the result of an increase in salaries and
related expense.
Preclinical
and Clinical Testing: Preclinical
and clinical testing includes expenses related to preclinical testing of our
own
and, in certain instances, our collaborators’ product candidates, and the cost
of our own clinical trials. Such expenses include personnel, patient enrollment
at our clinical testing sites, consultant fees, contract services, and facility
expenses. Preclinical
and clinical
testing expenses for the three months ended September 30, 2006 increased
$237,000 to $1.9 million compared to $1.7 million for the three months ended
September 30, 2005. This increase is primarily due to an increase in salaries
and related expense, as well as an increase in clinical trial costs resulting
from the advancement of our clinical trials.
Process
and Product Development:
Process and product development expenses include costs for development of
clinical and commercial manufacturing processes. Such expenses include the
costs
of personnel, contract services and facility expenses. For the
three months ended
September 30, 2006, total development expenses decreased $59,000 to $1.3
million, compared to $1.4 million for the three months ended September 30,
2005.
The decrease is primarily due to a decrease in contract service expense,
partially offset by an increase in salaries and related expense.
Manufacturing
Operations: Manufacturing
operations expense includes costs to manufacture preclinical and clinical
materials for our own product candidates and costs to support the operation
and
maintenance of our conjugate manufacturing plant. Such expenses include
personnel, raw materials for our preclinical and clinical trials, development
costs with contract manufacturing organizations, manufacturing supplies, and
facilities expense. Manufacturing costs related to the production of material
for our collaborators are recorded as cost of clinical material reimbursed
in
our statement of operations. For the
three months ended
September 30, 2006, manufacturing operations expense increased $1.6 million
to
$4.5 million compared to $2.9 million in the same period last year. The
increase in the first quarter of fiscal 2007 as compared to fiscal 2006 was
primarily the result of (i) an increase in contract service expense
substantially due to higher antibody purchases as well as development costs
with
contract manufacturing organizations for the potential production of later-stage
materials and (ii) and increase in disposable and chemical costs. Partially
offsetting these increases was higher overhead utilization from the manufacture
of clinical materials on behalf of our collaborators during the three months
ended September 30, 2006 as compared to the same period ended September 30,
2005.
General
and
Administrative Expenses
General
and administrative expenses for the three months ended September 30, 2006 were
level with the three months ended September 30, 2005 at $2.8 million. An
increase in patent expense was substantially offset by a decrease in facilities
expense. Patent costs rose primarily due to increased patents filed in
additional countries, resulting in additional fees. The decrease in facilities
expense was due to an adjustment made during the three months ended September
30, 2006 to reverse an incorrect accrual recorded in fiscal 2006 related to
operating expenses and real estate taxes associated with the 64 Sidney Street
office. The
Company does not believe such previously recorded expense was material to the
results of operations or the financial position of the Company for fiscal year
2006 or for the three months ended September 30, 2006.
Interest
Income
Interest
income for the three months ended September 30, 2006 increased $147,000 to
$865,000 from $718,000 for the three months ended September 30, 2005.
The
increase in interest income is primarily the result higher rates of return
resulting from higher yields on investments.
Net
Realized Losses on Investments
Net
realized losses on investments were $1,000 and $4,000 for the three months
ended
September 30, 2006 and 2005, respectively. The difference is attributable to
the
timing of investment sales.
LIQUIDITY
AND
CAPITAL RESOURCES
We
require
cash to fund our operating expenses, including the advancement of our own
clinical programs, and to make capital expenditures. Historically, we have
funded our cash requirements primarily through equity financings in public
markets and payments from our collaborators, including equity investments,
license fees and research funding. As of September 30, 2006, we had
approximately $70.3 million in cash and marketable securities.
Net
cash used for operations during the three months ended September 30, 2006 was
$4.6 million compared to $3.5 million during the three months ended September
30, 2005. The
principal use of cash in operating activities for all periods presented was
to
fund our net loss. The increase in operational cash use during the first quarter
of fiscal 2007 compared to the first quarter of fiscal 2006 is principally
due
to the increased net loss, as a result of increased research and development
costs compared to last year.
Net
cash
provided by investing activities during the three months ended September 30,
2006 was $6.0 million compared to $2.3 million during the three months ended
September 30, 2005. The variance primarily relates to an increase in the sale
and maturities of marketable securities. Capital expenditures, primarily for
the
purchase of new equipment, were $493,000 and $498,000 for the three-month
periods ended September 30, 2006 and 2005, respectively.
Net
cash
provided by financing activities was $26,000 for the three months ended
September 30, 2006 compared to net cash provided by financing activities of
$241,000 for the three months ended September 30, 2005. For the three
months ended September 30, 2006, net cash provided by financing activities
reflects the proceeds to us from the exercise of 11,250 stock options under
our
Restated Stock Option Plan, at a price of $2.30 per share. For the three
months ended September 30, 2005, net cash provided by financing activities
reflects the proceeds to us from the exercise of 55,494 stock options under
the
Company’s Restated Stock Option Plan, at prices ranging from $1.94 to $6.27 per
share.
We anticipate that our current capital resources and future collaborator
payments, including committed research funding that we expect to receive from
sanofi-aventis pursuant to the terms of our collaboration agreement, will enable
us to meet our operational expenses and capital expenditures for at least the
current and the next one to two fiscal years. We believe that our existing
capital resources in addition to our established collaborative agreements will
provide funding sufficient to allow us to meet our obligations under all
collaborative agreements while also allowing us to develop product candidates
and technologies not covered by collaborative agreements. However, we cannot
provide assurance that such collaborative agreement funding will, in fact,
be
received. Should we not meet some or all of the terms and conditions of our
various collaboration agreements, we may be required to pursue additional
strategic partners, secure alternative financing arrangements, and/or defer
or
limit some or all of our research, development and/or clinical
projects.
Recent
Accounting
Pronouncements
In
July
2006, the FASB issued Financial Interpretation No. (FIN) 48, Accounting
for
Uncertainty in Income Taxes, which
applies to all tax
positions related to income taxes subject to No. 109 (SFAS 109),
Accounting
for Income
Taxes.
This includes tax positions considered to be “routine” as well as those with a
high degree of uncertainty. FIN 48 utilizes a two-step approach for evaluating
tax positions. Recognition (step one) occurs when an enterprise concludes that
a
tax position, based solely on its technical merits, is more-likely-than-not
to
be sustained upon examination. Measurement (step two) is only addressed if
step
one has been satisfied (i.e., the position is more-likely-than-not to be
sustained). Under step two, the tax benefit is measured as the largest amount
of
benefit, determined on a cumulative probability basis that is
more-likely-than-not to be realized upon ultimate settlement. FIN 48’s use of
the term “more-likely-than-not” in steps one and two is consistent with how that
term is used in SFAS 109 (i.e., a likelihood of occurrence greater than 50
percent).
Those
tax
positions failing to qualify for initial recognition are recognized in the
first
subsequent interim period they meet the more-likely-than-not standard, or are
resolved through negotiation or litigation with the taxing authority, or upon
expiration of the statute of limitations. Derecognition of a tax position that
was previously recognized would occur when a company subsequently determines
that a tax position no longer meets the more-likely-than-not threshold of being
sustained. FIN 48 specifically prohibits the use of a valuation allowance as
a
substitute for derecognition of tax positions. Additionally, FIN 48 requires
expanded disclosure requirements, which include a tabular rollforward of the
beginning and ending aggregate unrecognized tax benefits as well as specific
detail related to tax uncertainties for which it is reasonably possible the
amount of unrecognized tax benefit will significantly increase or decrease
within twelve months.
These disclosures are
required at each annual reporting period unless a significant change occurs
in
an interim period. FIN 48 is effective for fiscal years beginning after
December 15, 2006 (our fiscal year 2008). We do not believe the adoption
will have material impact on our results of operation or financial position.
Forward-Looking
Statements
Various
statements in this Quarterly Report on Form 10-Q are forward-looking statements
concerning our future products, revenues, expenses, liquidity and cash needs,
as
well as our plans and strategies. Forward-looking statements give management’s
current expectations or forecasts of future events. You can identify these
statements by the fact that they do not relate strictly to historic or current
events. They use words such as “anticipate,” “estimate,” “expect,” “project,”
“intend,” “plan,” “believe,” “should,” “may,” “will,” and other words and terms
of similar meaning. These forward-looking statements are based upon current
expectations and we assume no obligation to update this information. Any or
all
of our forward-looking statements in this Quarterly Report on Form 10-Q may
turn
out to be wrong. They can be affected by inaccurate assumptions we might make
or
by known or unknown risks or uncertainties. Consequently, no forward-looking
statement can be guaranteed. Actual results may vary materially from those
set
forth in the forward-looking statements. Forward-looking statements, therefore,
should be considered in light of all of the information included or referred
to
in this Quarterly Report on Form 10-Q, including the cautionary information
set
forth under Part II, Item 1A., Risk Factors.
ITEM
3. Quantitative
and
Qualitative Disclosures about Market Risk
We
maintain an investment portfolio in accordance with our Investment Policy.
The
primary objectives of our Investment Policy are to preserve principal, maintain
proper liquidity to meet operating needs and maximize yields. Although our
investments are subject to credit risk, our Investment Policy specifies credit
quality standards for our investments and limits the amount of credit exposure
from any single issue, issuer or type of investment. Our investments are also
subject to interest rate risk and will decrease in value if market interest
rates increase. However, due to the conservative nature of our investments
and
relatively short duration, interest rate risk is mitigated. We do not own
derivative financial instruments in our investment portfolio. Accordingly,
we do
not believe that there is any material market risk exposure with respect to
derivative or other financial instruments that would require disclosure under
this item.
ITEM
4.
|
Controls
and
Procedures
|
(a)
|
Evaluation
of
Disclosure Controls and
Procedures
|
As
of the
end of the period covered by this report, the Company’s principal executive
officer and principal financial officer evaluated the effectiveness of the
Company’s disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and have concluded, based on such
evaluation, that the design and operation of the Company’s disclosure controls
and procedures were adequate and effective to ensure that material information
relating to the Company, including its consolidated subsidiaries, was made
known
to them by others within those entities, particularly during the period in
which
this Quarterly Report on Form 10-Q was being prepared.
(b)
|
Changes
in
Internal Controls
|
There
were no changes, identified in connection with the evaluation described above,
in the Company’s internal controls over financial reporting or in other factors
that could significantly affect those controls that have materially affected
or
are reasonably likely to materially affect, the Company’s internal control over
financial reporting.
ITEM
1.
|
Legal
Proceedings.
|
None.
We
have a history of operating losses and expect to incur significant additional
operating losses.
We
have
generated operating losses since our inception. As of September 30, 2006, we
had
an accumulated deficit of $244.8 million. For the three months ended
September 30, 2006, and the fiscal years ended June 30, 2006, 2005, and 2004,
we
generated losses of $6.3 million, $17.8 million, $11.0 million and $5.9 million,
respectively. We may never be profitable. We expect to incur substantial
additional operating expenses over the next several years as our research,
development, preclinical testing, clinical studies and collaborator support
activities increase. We intend to continue to invest significantly in our
product candidates. Further, we expect to invest significant resources
supporting our existing collaborators as they work to develop, test and
commercialize TAP and other antibody compounds, and we or our collaborators
may
encounter technological or regulatory difficulties as part of this development
and commercialization process that we cannot overcome or remedy. We may
also incur substantial marketing and other costs in the future if we decide
to
establish marketing and sales capabilities to commercialize our product
candidates. None of our product candidates has generated any commercial revenue
and our only revenues to date have been primarily from upfront and milestone
payments, research and development support and clinical materials reimbursement
from our collaborative partners. We do not expect to generate revenues from
the
commercial sale of our product candidates for several years, and we may never
generate revenues from the commercial sale of products. Even if we do
successfully develop products that can be marketed and sold commercially, we
will need to generate significant revenues from those products to achieve and
maintain profitability. Even if we do become profitable, we may not be able
to
sustain or increase profitability on a quarterly or annual basis.
If
we are unable to obtain additional funding when needed, we may have to delay
or
scale back some of our programs or grant rights to third parties to develop
and
market our products.
We
will
continue to expend substantial resources developing new and existing product
candidates, including costs associated with research and development, acquiring
new technologies, conducting preclinical and clinical trials, obtaining
regulatory approvals and manufacturing products as well as providing certain
support to our collaborators in the development of their products. We believe
that our current working capital and future payments, if any, from our
collaboration arrangements, including committed research funding that we expect
to receive from sanofi-aventis pursuant to the terms of our collaboration
agreement, will be sufficient to meet our current and projected operating and
capital requirements for at least the current and the next one to two fiscal
years. However, we may need additional financing sooner due to a number of
factors including:
|
§
|
if
either we or any of our collaborators incur higher than expected
costs or
experience slower than expected progress in developing product candidates
and obtaining regulatory approvals;
|
|
§
|
lower
revenues than expected under our collaboration agreements;
or
|
|
§
|
acquisition
of technologies and other business opportunities that require financial
commitments.
|
Additional
funding may not be available to us on favorable terms, or at all. We may raise
additional funds through public or private financings, collaborative
arrangements or other arrangements. Debt financing, if available, may involve
covenants that could restrict our business activities. If we are unable to
raise
additional funds through equity or debt financing when needed, we may be
required to delay, scale back or eliminate expenditures for some of our
development programs or grant rights to develop and market product candidates
that we would otherwise prefer to internally develop and market. If we are
required to grant such rights, the ultimate value of these product candidates
to
us may be reduced.
In
addition to the foregoing risk factors, for a complete set of risk factors,
please refer to the section entitled “Risk Factors” in our Annual Report on Form
10-K
for
our fiscal year ended June 30, 2006, on file with the Securities and Exchange
Commission.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
None.
ITEM
3.
|
Defaults
Upon Senior Securities.
|
None.
None.
ITEM
5.
|
Other
Information.
|
None.
|
10.1
|
Amendment
No. 1 to
the Collaboration and License Agreement with
sanofi-aventis.
|
|
10.2
|
Collaborative
Development and License Agreement with Biotest
AG.
|
|
10.3
|
Amendment
No. 1 to
Collaborative Development and License Agreement with Biotest
AG.
|
|
10.4
|
2004
Non-Employee
Director Compensation and Deferred Share Unit Plan, as Amended
September
5, 2006.
|
|
31.1
|
Certification
of
Chief Executive Officer under Section 302 of the Sarbanes-Oxley
Act of
2002.
|
|
31.2
|
Certification
of
Principal Financial Officer under Section 302 of the Sarbanes-Oxley
Act of
2002.
|
|
32.
|
Certifications
of
Chief Executive Officer and Principal Financial Officer under Section
906
of the Sarbanes-Oxley Act of
2002.
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
|
ImmunoGen, Inc.
|
|
|
|
Date:
November 3, 2006
|
By:
|
/s/
Mitchel Sayare
|
|
|
Mitchel
Sayare
|
|
|
President
and Chief Executive Officer
(principal
executive officer)
|
|
|
|
Date:
November 3, 2006
|
By:
|
/s/
Daniel M. Junius
|
|
|
Daniel
M. Junius
|
|
|
Executive
Vice President and Chief Financial Officer
(principal
financial officer)
|