Filed Pursuant to Rule 424(b)(3)
Registration No. 333-155784
PROSPECTUS
NEOGENOMICS,
INC.
6,500,000
Shares of Common Stock
This
prospectus relates to the sale of up to 6,500,000 shares of the common stock,
par value $0.001 per share, of NeoGenomics, Inc., a Nevada corporation, by the
selling stockholders named in this prospectus in the section “Selling
Stockholders”. In this prospectus we refer to NeoGenomics, Inc., a
Nevada corporation, individually as the “Parent Company” and
collectively with all of its subsidiaries as "Company," "we," "us," "our" and "NeoGenomics".
The
Company is not selling any shares of common stock in this offering and therefore
will not receive any proceeds from this offering. All costs associated with this
registration will be borne by the Company. The prices at which the
selling stockholders may sell the shares will be determined by the prevailing
market price for the shares or in negotiated transactions.
Our
common stock is quoted on the Over-The-Counter Bulletin Board under the
symbol “NGNM.OB”. On April 27, 2010, the last reported sale price of
our common stock was $1.42 per share.
One of
the selling stockholders, Fusion Capital Fund II, LLC, is an "underwriter"
within the meaning of the Securities Act of 1933, as amended (the “Securities
Act”).
These securities are speculative and
involve a high degree of risk. Please refer to “Risk Factors”
beginning on page 14 for a discussion of these risks.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus is May 20, 2010.
TABLE
OF CONTENTS
PROSPECTUS
SUMMARY
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2
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SUMMARY
CONSOLIDATED FINANCIAL INFORMATION
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10
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RISK
FACTORS
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14
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FORWARD-LOOKING
STATEMENTS
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26
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SELLING
STOCKHOLDERS
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27
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USE
OF PROCEEDS
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31
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PLAN
OF DISTRIBUTION
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32
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MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
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33
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DESCRIPTION
OF BUSINESS
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49
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PRINCIPAL
STOCKHOLDERS
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67
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MARKET
PRICE OF AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY AND OTHER
STOCKHOLDER MATTERS
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71
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CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
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72
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DESCRIPTION
OF CAPITAL STOCK
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74
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LEGAL
MATTERS
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77
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EXPERTS
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77
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AVAILABLE
INFORMATION
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77
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CONSOLIDATED
FINANCIAL STATEMENTS OF NEOGENOMICS, INC.
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F-i
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OTHER
EXPENSES OF ISSUANCE AND DISTRIBUTION
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II-1
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INDEMNIFICATION
OF DIRECTORS AND OFFICERS
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II-1
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RECENT
SALES OF UNREGISTERED SECURITIES
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II-2
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EXHIBITS
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II-4
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UNDERTAKINGS
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II-8
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SIGNATURES
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II-10
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The following is only a summary of the
information, financial statements and the notes thereto included in this
prospectus. You should read the entire prospectus carefully,
including “Risk Factors” and our consolidated financial statements and the notes
thereto before making any investment decision. NeoGenomics, Inc. is
referred to herein individually as the “Parent Company” or,
collectively with all of its subsidiaries, as the “Company”, “NeoGenomics”, or
“we”, “us”, or “our”.
Overview
NeoGenomics
operates a network of cancer-focused testing laboratories whose mission is to
improve patient care through exceptional cancer genetic diagnostic, prognostic
and predictive testing services. Our vision is to become America’s premier
cancer testing laboratory by delivering uncompromising quality, exceptional
service and innovative products and solutions. The Company’s laboratory network
currently offers the following types of testing services:
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a)
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cytogenetics
testing, which analyzes human
chromosomes;
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b)
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Fluorescence
In-Situ Hybridization (“FISH”) testing, which analyzes abnormalities at
the chromosomal and gene
levels;
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c)
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flow
cytometry testing, which analyzes gene expression of specific markers
inside cells and on cell
surfaces;
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d)
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immunohistochemistry
testing, which analyzes the distribution of tumor antigens in specific
cell and tissue types, and
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e)
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molecular
testing which involves analysis of DNA and RNA to diagnose and predict the
clinical significance of various genetic sequence
disorders.
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All of
these testing services are widely utilized in the diagnosis, prognosis, and
prediction for response to therapy of various types of cancers.
Market
Opportunity
The
medical testing laboratory market can be broken down into three primary
segments:
• clinical
lab testing,
• anatomic
pathology testing, and
• genetic
and molecular testing.
Clinical
laboratories are typically engaged in high volume, highly automated, lower
complexity tests on easily procured specimens such as blood and
urine. Clinical lab tests often involve testing of a less urgent
nature, for example, cholesterol testing and testing associated with routine
physical exams.
Anatomic
pathology (“AP”) testing involves evaluation of tissue, as in surgical
pathology, or cells as in cytopathology. The most widely performed AP
procedures include the preparation and interpretation of pap smears, skin
biopsies, and tissue biopsies.
Genetic
and molecular testing typically involves analyzing chromosomes, genes or DNA/RNA
sequences for abnormalities. New tests are being developed at an
accelerated pace, thus this market niche continues to expand
rapidly. Genetic and molecular testing requires highly specialized
equipment and credentialed individuals (typically MD or PhD level) to certify
results and typically yields the highest reimbursement levels of the three
market segments.
The
market for cancer testing is growing rapidly. Key factors influencing
this growth are: (i) cancer is primarily a disease of the elderly and
now that the baby boomer generation has started to turn sixty, the U.S. is
experiencing a significant increase in the number of senior citizens, (ii) the
American Cancer Society estimates that one in four senior citizens will develop
some form of cancer during the rest of their lifetime, and (iii) every year more
and more genes are discovered to have a specific link to cancer, which then
enables a genetic or molecular test to be developed. We
estimate that the Company addresses a $5-6 billion total United States market
opportunity, about half of which is derived from genetic and molecular testing
with the other half derived from more traditional anatomic pathology testing
services that are complementary to and often ordered with the genetic testing
services we offer.
Our
Focus
NeoGenomics’
primary focus is to provide high complexity laboratory testing for
community-based pathology, oncology, dermatology and urology markets in the
United States and the Caribbean. We focus on community-based practitioners for
two reasons: First, academic pathologists and associated clinicians tend to have
their testing needs met within the confines of their university affiliation.
Secondly, most of the cancer care in the United States is administered by
community based practitioners due to ease of local access. We currently provide
our services to pathologists and oncologists that perform bone marrow and/or
peripheral blood sampling for the diagnosis of blood and lymphoid tumors
(leukemias and lymphomas) and archival tissue referred for analysis of solid
tumors such as breast cancer. We also serve community-based urologists by
providing a FISH-based genetic test for the diagnosis of bladder cancer and
early detection of recurrent disease.
The high
complexity cancer testing services we offer to community-based pathologists are
designed to be a natural extension of and complementary to the services that our
pathologist clients perform within their own practices. Because fee-for-service
pathologists derive a significant portion of their annual revenue from the
interpretation of cancer biopsy specimens, they represent an important market
segment to us. We believe our relationship as a non-competitive partner to the
community-based pathologist empowers these pathologists to expand their testing
breadth and provide a menu of services that matches or exceeds the level of
service found in academic centers of excellence around the country.
We also
believe that we can provide a competitive choice to those larger oncology
practices that prefer to have a direct relationship with a laboratory for cancer
genetic testing services. Our regionalized approach allows us strong
interactions with clients and our innovative Genetic Pathology Solutions (“GPS”)
report summarizes all relevant case data on one summary report.
Competitive
Strengths
Turnaround
Times
At
NeoGenomics, we strive to provide industry leading turnaround times to our
clients nationwide and to provide information so that physicians can provide
their patients with the correct treatment as soon as possible.
We
believe our average 4-5 day turn-around time for our cytogenetics
testing services and our average 3-4 day turn-around time for FISH testing
services continue to be industry-leading benchmarks for national
laboratories. The consistent timeliness of results is a competitive
strength in cytogenetics and FISH testing and a driver of additional testing
requests by our referring physicians. Quick turn-around times for
cytogenetics and FISH tests allow for the performance of other tests to augment
or confirm results and improve patient care. Without rapid turnaround
times, there is an increased chance that the test results will not be returned
within an acceptable diagnostic window when other adjunctive diagnostic test
results are required. We believe our turn-around times result in our
referring physicians requesting more of our testing services and give us a
significant competitive advantage in marketing our services against those of
other competing laboratories.
National
Direct Sales Force
NeoGenomics
has assembled a strong direct sales force. Our sales representatives
(“Territory Business Managers”) are organized into four regions (Northeast,
Southeast, Central and West). These sales representatives are trained
extensively in cancer genetic testing and consultative selling
skills. As of April 27, 2010, we had 23 Territory Business Managers
and four Regional Managers.
Strategic
Supply Agreement with Abbott Molecular
In July 2009, we entered into a
Strategic Supply Agreement with Abbott Molecular, Inc, a wholly-owned subsidiary
of Abbott Laboratories. Under the terms of this agreement,
NeoGenomics has the rights to develop and exclusively launch three laboratory
developed tests (LDTs) based on intellectual property developed and/or licensed
by Abbott. We launched the first of these tests in February 2010, a
FISH test for the diagnosis of melanoma, and expect to launch the second test in
early 2011 and the third in 2012. In conjunction with the Strategic
Supply Agreement, Abbott Laboratories purchased a 9.6% stake in
NeoGenomics.
New
FISH Test for Melanoma
In
February 2010, we launched the first of the three tests developed pursuant to
the Strategic Supply Agreement with Abbott under the trade name
MelanoSITE™. MelanoSITE™ is a four probe FISH test that can be
used as a diagnostic aid to traditional histopathologic evaluation in diagnosing
melanoma. In conjunction with histopathology, the MelanoSITE™
test can help improve classification of melanocytic neoplasms with conflicting
morphologic criteria and help insure proper follow-up. Differential
diagnosis of moderate to severely atypical nevi versus true melanoma is one of
the most challenging areas in dermatopathology. While most melanomas
can be readily distinguished from nevi on histopathologic examination, we
estimate there are about 5% of cases that are ambiguous and show conflicting
morphologic criteria. Diagnostic ambiguity has significant adverse
consequences for patients and the healthcare system at large. Failure
to recognize melanoma is potentially fatal, but labeling a benign lesion as
malignant can lead to unwarranted wide re-excisions, sentinel lymph node
biopsies, adjuvant toxic therapeutic interventions and the emotional strain of
facing a diagnosis of cancer. Considering the large number of
biopsies done in the U.S. to either confirm or rule out melanoma, diagnostic
uncertainty of this scale represents a significant challenge to the U.S.
healthcare system. We believe the MelanoSITE™ test will help address
this diagnostic uncertainty and help to reduce the medical costs associated with
melanoma by providing a more accurate diagnosis.
The
performance characteristics of the MelanoSITE™ test were established in a
multicenter validation study involving over 500 cases, which resulted in a
sensitivity (a measure of true positives and false negatives) of 77% and a
specificity (a measure of true negatives and false positives) of
97%. Importantly, based on our study, the MelanoSITE™ test has a
negative predictive value (NPV) of over 98%. This means that
dermatopathologists and dermatologists can be confident that a patient with a
negative test result has a very low likelihood of having
melanoma. Therefore, the clinician may not need to perform a wide
re-excision of the lesion, potentially scarring a patient for life, and may not
need to perform a sentinel lymph node biopsy which can potentially lead to
further complications such as lymphedema. We expect the marketing and
selling of the MelanoSITE™ test to be a major focus of the Company during
2010.
Client
Care
NeoGenomics Customer Care Specialists
(“CCS”) are organized by region into territories that service not only our
external clients, but also work very closely with and support our sales
team. A client receives personalized assistance when dealing with
their dedicated CCS because each CCS understands their clients’ specific
needs. CCS’s handle everything from arranging specimen pickup to
delivering the results to fulfill NeoGenomics’ objective of delivering
exceptional services to our clients.
Geographic
Locations
In 2009,
we continued an aggressive campaign to regionalize our laboratory operations
around the country to be closer to our clients. Many high complexity
laboratories within the cancer testing niche have frequently operated a core
facility on one or both coasts to service the needs of their customers around
the country. We believe that our clients and prospects desire to do
business with a laboratory with national breadth and a local
presence. NeoGenomics’ has four facilities. The Chatsworth
California location is a small office laboratory for our pathologists. and we
have three main laboratory locations in Fort Myers, Florida; Irvine California;
and Nashville Tennessee and all facilities have the appropriate state licenses
and Clinical Laboratory Improvement Act, as amended (“CLIA”), and College of
American Pathologists (“CAP”) accreditations and are currently receiving
specimens. As situations dictate and opportunities arise, we will
continue to develop and open new laboratories, linked together by our optimized
Laboratory Information System (“LIS”), to better meet the regionalized needs of
our clients.
Laboratory
Information System
NeoGenomics has what we believe is a
state of the art LIS that interconnects our locations and provides flexible
reporting options to clients. This system allows us to deliver
uniform test results throughout our network, regardless of where the lab that
performs any specific test is located. This allows us to move
specimens between locations to better balance our workload. Our LIS
also allows us to offer highly specialized services to certain sub-segments of
our client base. For instance, our tech-only NeoFISHTM and
NeoFLOWTM
applications allow our community-based pathologist clients to tailor individual
reports to their own customizable report templates. This feature has
been well-received by our tech-only clients.
Scientific
Pipeline
The field of cancer genetics is rapidly
evolving, and we are committed to developing and offering new tests to meet the
needs of the market place based on the latest scientific
discoveries. During 2009, in addition to the validation work
performed for our exclusive Melanoma FISH test, the Company made significant
strides in developing the capability to perform molecular diagnostic testing
in-house. We believe that by adding additional types of tests to our
product offering, we will be able to increase our testing volumes through our
existing client base as well as more easily attract new clients via the ability
to package our testing services more appropriately to the needs of the
market. We expect to launch at least five new molecular tests in
fiscal year 2010.
Competition
We
operate in segments of the medical testing laboratory industry that are highly
competitive. Competitive factors in the genetic and molecular testing
business generally include the reputation of the laboratory, range of services
offered, pricing, convenience of sample collection and pick-up, quality of
analysis and reporting, medical staff, timeliness of delivery of
completed reports (i.e. turnaround times) and post-reporting follow-up for
clients.
Our
competitors in the United States are numerous and include major medical testing
laboratories. Many of these competitors have greater financial
resources and production capabilities. These companies may succeed in
developing service offerings that are more effective than any that we have or
may develop, and may also prove to be more successful than we are in marketing
such services. In addition, technological advances or different approaches
developed by one or more of our competitors may render our products obsolete,
less effective or uneconomical.
We
estimate that the United States market for genetic and molecular testing is
divided among approximately 300 laboratories. Approximately 80% of these
laboratories are attached to academic institutions and primarily provide
clinical services to their affiliate university hospitals. We believe that the
remaining 20% is quite fragmented and that less than 20 laboratories market
their services nationally. We estimate that the top 20 laboratories
account for approximately 50% of market revenues for genetic and molecular
testing.
We intend
to continue to gain market share by offering industry-leading turnaround times,
a broad service menu, high-quality test reports, bringing new tests to market,
and enhanced post-test consultation services through our direct sales
force. In addition, we have a fully integrated and interactive
internet-enabled LIS that enables us to report real time results to clients in a
secure environment.
Global
Products
We offer
a full set of global services to meet the needs of our clients to improve
patient care. In our global service offerings, our lab performs the
technical component of tests, and our M.D.s and Ph.D.’s interpret the test
results for our clients (known as the professional component). This
product line provides a comprehensive testing service to those clients who are
not credentialed and trained in interpreting genetic and molecular
tests. Global products also allow NeoGenomics to derive a higher
level of reimbursement than would otherwise be possible with a tech-only test.
This product also services the needs of physicians who are looking for ways to
save their time.
We
increased our professional level staffing for global requisitions requiring
interpretation in 2008 and 2009. Importantly, in April 2008 we
recruited two well-known hematopathologists to NeoGenomics at our Irvine,
California laboratory location, enabling this west coast facility to become the
mirror image of our main facility in Fort Myers, Florida. We
currently employ four full-time MDs as our medical directors and pathologists,
two PhDs as our scientific directors and cytogeneticists, and one part-time MD
acting as a consultant and backup pathologist for case sign out
purposes. We have plans to hire several more pathologists in 2010 as
our product mix continues to expand beyond tech-only services and more sales
emphasis is focused on our ability to issue consolidated reporting with case
interpretation under our Genetic Pathology Solutions (“GPS”) product
line.
Tech-Only
Products
In 2006,
NeoGenomics launched what we believe was the first technical component only
(“tech-only”) FISH product offering in the United States. Tech-only
products allow our community-based pathology clients that are properly trained
and credentialed to provide services to clinicians based on established and
trusted relationships. These pathologist clients perform the professional
interpretation of results themselves and bill for such work under the physician
fee schedule. For tech-only FISH, NeoGenomics performs the technical
component of the test (specimen set-up, staining, sorting and categorization of
cells, chromosomes, genes or DNA, etc) and the pathology client performs the
professional component. This allows NeoGenomics to partner with its
pathology clients and provides for close collaboration in meeting market
needs. Prior to the advent of tech-only products, pathologists who
did not have a genetic lab would have had to send all of the work out to a
reference lab. Utilizing NeoFISHTM,
pathologist clients are empowered to extend the outreach efforts of their
practices and exert a high level of involvement in the delivery of high quality
patient care.
NeoFLOWTM
tech-only flow cytometry was launched as a companion service to NeoFISHTM in late
2007. We believe the NeoFLOWTM service
offering will continue to be a key growth driver for the Company in
2010. Moreover, the combination of NeoFLOWTM and
NeoFISHTM
strengthens and differentiates NeoGenomics and allows us to compete more
favorably against larger, more entrenched competitors in our testing
niche.
Sales and
Marketing
We
continue to grow our testing volumes and revenue due to our expanding field
sales footprint. As of April 27, 2010, NeoGenomics’ sales and
marketing team totaled 34 individuals, including 23 Territory Business Managers
(sales representatives), four Regional Managers and six marketing and management
professionals. During 2009, we made significant investments in sales
and marketing personnel and we expect to realize the positive effects of those
investments in 2010.
As
a result of our expanding sales force, we experienced 47% year-over-year revenue
growth to $29.5 million in 2009 from $20.0 million in 2008. Our
average revenue/requisition increased 15% to $931 in 2009 from $808 in 2008 due
to a higher mix on global products with interpretation and an increase of higher
revenue flow cytometry testing as a percentage of our total
revenue.
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FY 2009
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FY 2008
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% Increase
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Client
Requisitions Received (Cases)
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|
31,638 |
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24,780 |
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28 |
% |
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|
|
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Number
of Tests Performed
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45,675 |
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32,539 |
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40 |
% |
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|
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|
|
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Average
Number of Tests/Requisition
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|
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1.44 |
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|
1.31 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
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Total
Testing Revenue
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|
$ |
29,469,000 |
|
|
$ |
20,015,000 |
|
|
|
47 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
Revenue/Requisition
|
|
$ |
931 |
|
|
$ |
808 |
|
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
Revenue/Test
|
|
$ |
645 |
|
|
$ |
615 |
|
|
|
5 |
% |
Within
the subspecialty field of hematopathology, our scientific expertise and product
offering allows us to be able to perform multiple tests on each specimen
received. Many physicians believe that a comprehensive approach to
the diagnosis and prognosis of blood and lymph node disease to be the standard
of care throughout the country. As the average number of tests
performed per requisition increases, we believe this will help to generate
significant synergies and efficiencies in our operations and our sales and
marketing activities.
Seasonality
The majority of our testing volume is
dependent on patients being treated by hematology/oncology professionals and
other healthcare providers. The volume of our testing services generally
declines during the summer vacation season, year-end holiday periods and other
major holidays, particularly when those holidays fall during the middle of the
week. In addition, the volume of our testing tends to decline due to adverse
weather conditions, such as excessively hot or cold spells, heavy snow,
hurricanes or tornados in certain regions, consequently reducing revenues and
cash flows in any affected period. Therefore, comparison of the results of
successive periods may not accurately reflect trends for future
periods.
Distribution
Methods
The
Company currently performs the vast majority of its testing services at each of
its three main clinical laboratory locations: Fort Myers, Florida, Nashville,
Tennessee and Irvine, California, and then produces a report for the requesting
physician. We also have a facility for our California medical staff
in Chatsworth, California. Services performed in-house include
cytogenetics, FISH, flow cytometry, morphology, immunohistochemistry, and some
molecular testing. The Company currently outsources approximately
half of its molecular testing to third parties, but expects to validate and
perform the majority of this testing in-house during 2010 to better meet client
demand and quality requirements.
Suppliers
The
Company orders its laboratory and research supplies from large national
laboratory supply companies such as Abbott Laboratories, Fisher Scientific,
Invitrogen, Cardinal Health, Ventana and Beckman Coulter. Other than
as discussed below, we do not believe any disruption from any one of these
suppliers would have a material effect on our business. The Company
orders the majority of its FISH probes from Abbott Laboratories and as a result
of their dominance of that marketplace and the absence of any competitive
alternatives, if there was a disruption in the supply of these probes, and we
did not have inventory available, it could have a material effect on our
business. This risk cannot be completely offset due to the fact that
Abbott Laboratories has patent protection which limits other vendors from
supplying these probes.
Dependence on Major
Clients
We
currently market our services to pathologists, oncologists, urologists,
hospitals and other clinical laboratories. During 2009, we performed
45,675 individual tests. Ongoing sales efforts have decreased
dependence on any given source of revenue. Notwithstanding this fact,
one key client accounts for a disproportionately large case volume and revenue
total. For the years ended December 31, 2009 and 2008, one client
with multiple locations accounted for 10% and 22% respectively, of total
revenue. As a result of this one customer bringing certain tests
in-house, this client represented less than 5% of our fourth quarter 2009
revenue. All others were less than 5% of total revenue
individually.
Payor
Mix
In 2009,
approximately 49% of our revenue was derived from Medicare claims, 26% from
commercial insurance companies, 24% from clients such as hospitals and other
reference laboratories, and 1% from all others including patients. As
of December 31, 2009, Medicare and one commercial insurance provider accounted
for 28% and 9% of the Company’s total accounts receivable balance,
respectively. There is no other significant concentration in our
payor mix.
Trademarks
The
“NeoGenomics” name and logo has been trademarked with the United States Patent
and Trademark Office. We have also trademarked the brand names MelanoSITE
and DermFISH related to our melanoma FISH test.
About
Us
Our
principal executive offices are located at 12701 Commonwealth Drive, Suite 5,
Fort Myers, Florida 33913. Our telephone number is (239)
768-0600. Our website can be accessed at www.neogenomics.org.
THE
OFFERING
This
prospectus relates to the offer and sale of up to 6,500,000 shares of our common
stock by the selling stockholders described below.
Fusion Capital
On
November 5, 2008, the Company and Fusion Capital Fund II, LLC, an Illinois
limited liability company (“Fusion Capital”),
entered into a Common Stock Purchase Agreement (the “Purchase Agreement”),
and a Registration Rights Agreement (the “Registration Rights
Agreement”). Under the Purchase Agreement, Fusion Capital is
obligated, under certain conditions, to purchase shares from us in an aggregate
amount of $8.0 million from time to time over a thirty (30) month
period. Under the terms of the Purchase Agreement, Fusion Capital has
received a commitment fee consisting of 400,000 shares of our common
stock. As of April 27, 2010, there were 37,278,667 shares outstanding
26,842,462 shares held by non-affiliates) excluding the 3,000,000 shares offered
by Fusion Capital pursuant to this prospectus which it has not yet purchased
from us. If all of such 3,000,000 shares offered hereby were issued
and outstanding as of the date hereof, the 3,000,000 shares would represent 7.4%
of the total common stock outstanding or 11.2% of the non-affiliates shares
outstanding as of the date hereof.
Under the
Purchase Agreement and the Registration Rights Agreement we are required to
register and have included in the offering pursuant to this prospectus (1)
400,000 shares which have already been issued as a commitment fee, (2) 17,500
shares which we have issued to Fusion Capital as an expense reimbursement and
(3) at least 3,000,000 shares which we may sell to Fusion Capital in the
future. All 3,417,500 shares, 10.6% of our outstanding on November 5,
2008, the date of the Purchase Agreement, are being offered pursuant to this
prospectus. Under the Purchase Agreement, we have the right but not
the obligation to sell more than the 3,000,000 shares to Fusion
Capital. As of the date hereof, we do not currently have any plans or
intent to sell to Fusion Capital any shares beyond the 3,000,000 shares offered
hereby. However, if we elect to sell more than the 3,000,000 shares
(which we have the right but not the obligation to do), we must first register
such additional shares under the Securities Act before we can elect to sell such
additional shares to Fusion Capital. In the event we elect to do so,
this could cause substantial dilution to our shareholders. The number
of shares ultimately offered for sale by Fusion Capital is dependent upon the
number of shares purchased by Fusion Capital under the Purchase
Agreement.
We do not
have the right to commence any sales of our shares to Fusion Capital until the
SEC has declared effective the registration statement of which this prospectus
is a part. The registration statement was declared effective on
February 5, 2009 and the conditions to commence funding were
satisfied. Generally, we have the right but not the obligation from
time to time to sell our shares to Fusion Capital in amounts between $50,000 and
$1.0 million depending on certain conditions. We have the right to
control the timing and amount of any sales of our shares to Fusion
Capital. The purchase price of the shares will be determined based
upon the market price of our shares without any fixed discount at the time of
each sale. Fusion Capital shall not have the right nor the obligation
to purchase any shares of our common stock on any business day that the price of
our common stock is below $0.45. There are no negative covenants,
restrictions on future fundings, penalties or liquidated damages in the Purchase
Agreement or the Registration Rights Agreement. The Purchase
Agreement may be terminated by us at any time at our discretion without any cost
to us. The Purchase Agreement provides that neither party has the
ability to amend the Purchase Agreement and the obligations of both parties are
non-transferable.
Other Selling Stockholders
|
·
|
Aspen
Select Healthcare, LP (“Aspen”), which
intends to sell up to 2,130,364 shares of common stock previously issued
and sold by the Company to Aspen on April 15, 2003 (the “2003 Aspen
Placement”). Aspen received registration rights
with respect to these shares and therefore, such shares are being
registered hereunder.
|
|
·
|
Mary
S. Dent, the spouse of Dr. Michael Dent, who is our founder, who intends
to sell up to 553,488 shares of common stock previously issued and sold by
the Company to Dr. Dent as founder shares. Such shares were
subsequently transferred to Mary Dent in February 2007. Dr.
Dent received registration rights with respect to these shares and
therefore, such shares are being registered
hereunder.
|
|
·
|
Those
shareholders other than Aspen and Mary Dent who are set forth in the
section herein entitled “Selling Stockholders” who intend to sell up to an
aggregate of 398,648 shares of common stock which they received in a
distribution from Aspen in September 2007. All of such shares
were originally purchased by Aspen in the 2003 Aspen
Placement. Aspen received registration rights with respect to
these shares and has assigned such rights to these selling stockholders
and therefore, such shares are being registered
hereunder.
|
Please
refer to “Selling Stockholders” beginning on page 27.
The Company is not selling any shares
of common stock in this offering and therefore will not receive any proceeds
from this offering. All costs associated with this registration will be borne by
the Company. The prices at which the selling stockholders may sell
the shares will be determined by the prevailing market price for the shares or
in negotiated transactions.
Our
common stock is quoted on the Over-The-Counter Bulletin Board under the
symbol “NGNM.OB”. On April 27, 2010, the last reported sale price of
our common stock on the Over-The-Counter Bulletin Board was $1.42 per
share.
Common
Stock Offered
|
6,500,000
shares by selling stockholders
|
|
|
Offering
Price
|
Market
price
|
|
|
Common
Stock Currently Outstanding
|
37,278,667
shares as of April 27, 2010
|
|
|
Use
of Proceeds
|
We
will not receive any proceeds of the shares offered by the selling
stockholders. See “Use of Proceeds”.
|
|
|
Risk
Factors
|
The
securities offered hereby involve a high degree of risk. See “Risk
Factors” beginning on page 14 for a discussion of these
risks.
|
|
|
Over-the-Counter
Bulletin Board Symbol
|
NGNM.OB
|
The Summary Consolidated Financial
Information set forth below was excerpted from the Company’s Quarterly Report on
Form 10-Q for the three months ended March 31, 2010 as filed with the
SEC.
Statement
of Operations Data (unaudited, in thousands except per share
amounts)
|
|
For the three months
ended March 31,
|
|
|
|
2010
|
|
|
2009
|
|
NET
REVENUE
|
|
$ |
8,418 |
|
|
$ |
6,914 |
|
COST
OF REVENUE
|
|
|
4,344 |
|
|
|
3,091 |
|
GROSS
MARGIN
|
|
|
4,074 |
|
|
|
3,823 |
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
2,902 |
|
|
|
2,341 |
|
Sales
and marketing
|
|
|
1,763 |
|
|
|
1,334 |
|
Total
operating expenses
|
|
|
4,665 |
|
|
|
3,675 |
|
|
|
|
|
|
|
|
|
|
INCOME/
(LOSS) FROM OPERATIONS
|
|
|
(591 |
) |
|
|
148 |
|
|
|
|
|
|
|
|
|
|
Other
income / (expense) – net
|
|
|
(159 |
) |
|
|
(115 |
) |
|
|
|
|
|
|
|
|
|
NET
INCOME / (LOSS)
|
|
$ |
(750 |
) |
|
$ |
33 |
|
NET
(LOSS) PER SHARE
|
|
|
|
|
|
|
|
|
—
Basic
|
|
$ |
(0.02 |
) |
|
$ |
0.00 |
|
—
Diluted
|
|
$ |
(0.02 |
) |
|
$ |
0.00 |
|
WEIGHTED
AVERAGE NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
|
|
|
—
Basic
|
|
|
37,220 |
|
|
|
32,173 |
|
—
Diluted
|
|
|
37,220 |
|
|
|
35,630 |
|
Balance
Sheet Data (in thousands except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
1,661 |
|
|
$ |
1,631 |
|
Restricted
cash
|
|
|
1,000 |
|
|
|
1,000 |
|
Accounts
receivable (net of allowance for doubtful accounts of $695 and $589,
respectively)
|
|
|
5,492 |
|
|
|
4,632 |
|
Inventories
|
|
|
582 |
|
|
|
602 |
|
Other
current assets
|
|
|
515 |
|
|
|
655 |
|
Total
current assets
|
|
|
9,250 |
|
|
|
8,520 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment (net of accumulated depreciation of $3,202 and $2,787
respectively)
|
|
|
4,882 |
|
|
|
4,340 |
|
Other
assets
|
|
|
86 |
|
|
|
85 |
|
Total
Assets
|
|
$ |
14,218 |
|
|
$ |
12,945 |
|
|
|
|
|
|
|
|
|
|
Liabilities
& Stockholders’ Equity:
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
Account
payable
|
|
$ |
1,762 |
|
|
$ |
1,969 |
|
Accrued
compensation
|
|
|
1,007 |
|
|
|
1,308 |
|
Accrued
expenses and other liabilities
|
|
|
439 |
|
|
|
465 |
|
Short-term
portion of equipment capital leases
|
|
|
1,823 |
|
|
|
1,482 |
|
Revolving
credit line
|
|
|
2,453 |
|
|
|
552 |
|
Total
current liabilities
|
|
|
7,484 |
|
|
|
5,776 |
|
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities
|
|
|
|
|
|
|
|
|
Long-term
portion of equipment capital leases
|
|
|
1,631 |
|
|
|
1,526 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities
|
|
|
9,115 |
|
|
|
7,302 |
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
Equity:
|
|
|
|
|
|
|
|
|
Common
Stock, $0.001 par value, (100,000,000 shares authorized; 37,270,055 and
37,185,078 shares issued and outstanding at March 31, 2010 and December
31, 2009, respectively)
|
|
|
37 |
|
|
|
37 |
|
Additional
paid-in capital
|
|
|
23,972 |
|
|
|
23,762 |
|
Accumulated
deficit
|
|
|
(18,906 |
) |
|
|
(18,156 |
) |
Total
stockholders’ equity
|
|
|
5,103 |
|
|
|
5,643 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders’ Equity
|
|
$ |
14,218 |
|
|
$ |
12,945 |
|
The
Summary Consolidated Financial Information set forth below was excerpted from
the Company’s Annual Report on Form 10-K for the year ended December
31, 2009 as filed with the SEC.
Statement
of Operations Data (in thousands except per share data)
|
|
For
the year
ended December 31,
|
|
|
|
2009
|
|
|
2008
|
|
NET
REVENUE
|
|
$ |
29,469 |
|
|
$ |
20,015 |
|
COST
OF REVENUE
|
|
|
14,254 |
|
|
|
9,354 |
|
GROSS
MARGIN
|
|
|
15,215 |
|
|
|
10,661 |
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
10,057 |
|
|
|
8,179 |
|
Sales
and marketing
|
|
|
6,886 |
|
|
|
3,366 |
|
Total
operating expenses
|
|
|
16,943 |
|
|
|
11,545 |
|
|
|
|
|
|
|
|
|
|
INCOME/
(LOSS) FROM OPERATIONS
|
|
|
(1,728 |
) |
|
|
(884 |
) |
|
|
|
|
|
|
|
|
|
Other
income / (expense) – net
|
|
|
(515 |
) |
|
|
(499 |
) |
|
|
|
|
|
|
|
|
|
NET
(LOSS)
|
|
$ |
(2,243 |
) |
|
$ |
(1,383 |
) |
NET
(LOSS) PER SHARE
|
|
|
|
|
|
|
|
|
—
Basic
|
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
—
Diluted
|
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
WEIGHTED
AVERAGE NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
|
|
|
—
Basic
|
|
|
34,639 |
|
|
|
31,507 |
|
—
Diluted
|
|
|
34,639 |
|
|
|
31,507 |
|
Balance
Sheet Data (in thousands except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
1,631 |
|
|
$ |
468 |
|
Restricted
cash
|
|
|
1,000 |
|
|
|
- |
|
Accounts
receivable (net of allowance for doubtful accounts of $589 and $359,
respectively)
|
|
|
4,632 |
|
|
|
2,914 |
|
Inventories
|
|
|
602 |
|
|
|
491 |
|
Other
current assets
|
|
|
655 |
|
|
|
483 |
|
Total
current assets
|
|
|
8,520 |
|
|
|
4,356 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment (net of accumulated depreciation of $2,787 and $1,603
respectively)
|
|
|
4,340 |
|
|
|
2,875 |
|
Other
assets
|
|
|
85 |
|
|
|
64 |
|
Total
Assets
|
|
$ |
12,945 |
|
|
$ |
7,295 |
|
|
|
|
|
|
|
|
|
|
Liabilities
& Stockholders’ Equity:
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
Account
payable
|
|
$ |
1,969 |
|
|
$ |
1,512 |
|
Accrued
compensation
|
|
|
1,308 |
|
|
|
737 |
|
Accrued
expenses and other liabilities
|
|
|
465 |
|
|
|
358 |
|
Short-term
portion of equipment capital leases
|
|
|
1,482 |
|
|
|
637 |
|
Revolving
credit line
|
|
|
552 |
|
|
|
1,147 |
|
Total
current liabilities
|
|
|
5,776 |
|
|
|
4,391 |
|
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities
|
|
|
|
|
|
|
|
|
Long-term
portion of equipment capital leases
|
|
|
1,526 |
|
|
|
1,403 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities
|
|
|
7,302 |
|
|
|
5,794 |
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
Equity:
|
|
|
|
|
|
|
|
|
Common
Stock, $0.001 par value, (100,000,000 shares authorized; 37,185,078 and
32,117,008 shares issued and outstanding at December 31, 2009 and 2008,
respectively)
|
|
|
37 |
|
|
|
32 |
|
Additional
paid-in capital
|
|
|
23,762 |
|
|
|
17,382 |
|
Accumulated
deficit
|
|
|
(18,156 |
) |
|
|
(15,913 |
) |
Total
stockholders’ equity
|
|
|
5,643 |
|
|
|
1,501 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders’ Equity
|
|
$ |
12,945 |
|
|
$ |
7,295 |
|
RISK
FACTORS
We
are subject to various risks that may materially harm our business, financial
condition and results of operations. An investor should carefully consider the
risks and uncertainties described below and the other information in this filing
before deciding to purchase our common stock. If any of these risks or
uncertainties actually occurs, our business, financial condition or operating
results could be materially harmed. In that case, the trading price of our
common stock could decline or we may be forced to cease operations.
Risks
Related To Our Business
We
May Not Be Able To Implement Our Business Strategies Which Could Impair Our
Ability To Continue Operations
Implementation
of our business strategies will depend in large part on our ability to (i)
attract and maintain a significant number of clients; (ii) effectively provide
acceptable products and services to our clients; (iii) obtain adequate financing
on favorable terms to fund our business strategies; (iv) maintain appropriate
procedures, policies, and systems; (v) hire, train, and retain skilled employees
and management; (vi) continue to operate with increasing competition in the
medical laboratory industry; (vii) establish, develop and maintain name
recognition; and (viii) establish and maintain beneficial relationships with
third-party insurance providers and other third party payors. Our
inability to obtain or maintain any or all these factors could impair our
ability to implement our business strategies successfully, which could have
material adverse effects on our results of operations and financial
condition.
We
May Be Unsuccessful In Managing Our Growth Which Could Prevent The Company From
Becoming Profitable
Our
recent growth has placed, and is expected to continue to place, a significant
strain on our managerial, operational and financial resources. To
manage our potential growth, we must continue to implement and improve our
operational and financial systems and to expand, train and manage our employee
base. We may not be able to effectively manage the expansion of our
operations and our systems and our procedures or controls may not be adequate to
support our operations. Our management may not be able to achieve the
rapid execution necessary to fully exploit the market opportunity for our
products and services. Any inability to manage growth could have a
material adverse effect on our business, results of operations, potential
profitability and financial condition. Part of our business strategy
may be to acquire assets or other companies that will complement our existing
business. At this time, we are unable to predict whether or when any material
transaction will be completed should negotiations commence. If we
proceed with any such transaction, we may not be able to effectively integrate
the acquired operations with our own operations. We may also seek to
finance any such acquisition by debt financings or issuances of equity
securities and such financing may not be available on acceptable terms or at
all.
We
May Incur Greater Costs Than Anticipated, Which Could Result In Sustained
Losses
We used
reasonable efforts to assess and predict the expenses necessary to pursue our
business plan. However, implementing our business plan may require more
employees, capital equipment, supplies or other expenditure items than
management has predicted. Similarly, the cost of compensating
additional management, employees and consultants or other operating costs may be
more than we estimate, which could result in ongoing and sustained
losses.
We
Rely On A Limited Number Of Third Parties For Manufacture And Supply Of Certain
Of Our Critical Laboratory Instruments And Materials, And We May Not Be Able To
Find Replacement Suppliers Or Manufacturers In A Timely Manner In The Event Of
Any Disruption, Which Could Adversely Affect Our Business
We rely on third parties for the
manufacture and supply of some of our critical laboratory instruments, equipment
and materials that we need to perform our specialized diagnostic services, and
rely on a limited number of suppliers for certain laboratory materials and some
of the laboratory equipment with which we perform our diagnostic services.
Generally, we do not have long-term contracts with our suppliers and
manufacturers that commit them to supply equipment and materials to us. Because
we cannot ensure the actual production or manufacture of such critical equipment
and materials, or the ability of our suppliers to comply with applicable legal
and regulatory requirements, we may be subject to significant delays caused by
interruption in production or manufacturing. If any of our third party suppliers
or manufacturers were to become unwilling or unable to provide this equipment or
these materials in required quantities or on our required timelines, we would
need to identify and acquire acceptable replacement sources on a timely basis.
While we have developed alternate sourcing strategies for most of the equipment
and materials we use, we cannot be certain that these strategies will be
effective and even if we were to identify other suppliers and manufacturers for
the equipment and materials we need to perform our specialized diagnostic
services, there can be no assurance that we will be able to enter into
agreements with such suppliers and manufacturers or otherwise obtain such items
on a timely basis or on acceptable terms, if at all. In addition, some of the
reagents we use to perform certain FISH tests are covered by a patent and thus
are only available from one supplier. If we encounter delays or
difficulties in securing necessary laboratory equipment or materials, including
consumables, we would face an interruption in our ability to perform our
specialized diagnostic services and experience other disruptions that would
adversely affect our business, results of operations and financial
condition.
We
May Face Fluctuations In Results Of Operations Which Could Negatively Affect Our
Business Operations And We Are Subject To Seasonality In Our
Business
As a
result of our limited operating history and the relatively limited information
available on our competitors, we may not have sufficient internal or
industry-based historical financial data upon which to calculate anticipated
operating expenses. Management expects that our results of operations
may also fluctuate significantly in the future as a result of a variety of
factors, including, but not limited to: (i) the continued rate of growth, usage
and acceptance of our products and services; (ii) demand for our products and
services; (iii) the introduction and acceptance of new or enhanced products or
services by us or by competitors; (iv) our ability to anticipate and effectively
adapt to developing markets and to rapidly changing technologies; (v) our
ability to attract, retain and motivate qualified personnel; (vi) the
initiation, renewal or expiration of significant contracts with our major
clients; (vii) pricing changes by us, our suppliers or our competitors; (viii)
seasonality; and (ix) general economic conditions and other
factors. Accordingly, future sales and operating results are
difficult to forecast. Our expenses are based in part on our
expectations as to future revenues and to a significant extent are relatively
fixed, at least in the short-term. We may not be able to adjust spending in a
timely manner to compensate for any unexpected revenue
shortfall. Accordingly, any significant shortfall in relation to our
expectations would have an immediate adverse impact on our business, results of
operations and financial condition. In addition, we may determine
from time to time to make certain pricing or marketing decisions or acquisitions
that could have a short-term material adverse affect on our business, results of
operations and financial condition and may not result in the long-term benefits
intended. Furthermore, in Florida, currently our primary referral
market for lab testing services, a meaningful percentage of the population,
returns to homes in the Northern U.S. to avoid the hot summer
months. This combined with the usual summer vacation schedules
of our clients usually results in seasonality in our
business. Because of all of the foregoing factors, our operating
results could be less than the expectations of investors in future
periods.
We
Substantially Depend Upon Third Parties For Payment Of Services, Which Could
Have A Material Adverse Affect On Our Cash Flows And Results Of
Operations
The
Company is a clinical medical laboratory that provides medical testing services
to doctors, hospitals, and other laboratories on patient specimens that are sent
to the Company. In the case of most specimen referrals that are
received for patients that are not in-patients at a hospital or institution or
otherwise sent by another reference laboratory, the Company generally has to
bill the patient’s insurance company or a government program for its
services. As such it relies on the cooperation of numerous third
party payors, including but not limited to Medicare, Medicaid and various
insurance companies, in order to get paid for performing services on behalf of
the Company’s clients. Wherever possible, the amount of such third
party payments is governed by contractual relationships in cases where the
Company is a participating provider for a specified insurance company or by
established government reimbursement rates in cases where the Company is an
approved provider for a government program such as Medicare. However,
the Company does not have a contractual relationship with many of the insurance
companies with whom it deals, nor is it necessarily able to become an approved
provider for all government programs. In such cases, the Company is
deemed to be a non-participating provider and there is no contractual assurance
that the Company is able to collect the amounts billed to such insurance
companies or government programs. Currently, the Company is not a
participating provider with the majority of the insurance companies it bills for
its services. Until such time as the Company becomes a participating
provider with such insurance companies, there can be no contractual assurance
that the Company will be paid for the services it bills to such insurance
companies, and such third parties may change their reimbursement policies for
non-participating providers in a manner that may have a material adverse effect
on the Company’s cash flow or results of operations.
Our
Business Is Subject To Rapid Scientific Change, Which Could Have A Material
Adverse Affect On Our Business, Results of Operations And Financial
Condition
The
market for genetic and molecular testing services is characterized by rapid
scientific developments, evolving industry standards and customer demands, and
frequent new product introductions and enhancements. Our future
success will depend in significant part on our ability to continually improve
our offerings in response to both evolving demands of the marketplace and
competitive service offerings, and we may be unsuccessful in doing
so.
The
Market For Our Services Is Highly Competitive, Which Could Have A Material
Adverse Affect On Our Business, Results Of Operations And Financial
Condition
The
market for genetic and molecular testing services is highly competitive and
competition is expected to continue to increase. We compete with other
commercial medical laboratories in addition to the in-house laboratories of many
major hospitals. Many of our existing competitors have significantly
greater financial, human, technical and marketing resources than we
do. Our competitors may develop products and services that are
superior to ours or that achieve greater market acceptance than our
offerings. We may not be able to compete successfully against current
and future sources of competition and in such case, this may have a material
adverse effect on our business, results of operations and financial
condition.
We
Face The Risk of Capacity Constraints, Which Could Have A Material Adverse
Affect On Our Business, Results Of Operations And Financial
Condition
We
compete in the market place primarily on three factors: a) the
quality and accuracy of our test results; b) the speed or turn-around times of
our testing services; and c) our ability to provide after-test support to those
physicians requesting consultation. Any unforeseen increase in the
volume of clients could strain the capacity of our personnel and systems, which
could lead to inaccurate test results, unacceptable turn-around times, or
customer service failures. In addition, as the number of clients and
cases increases, our products, services, and infrastructure may not be able to
scale accordingly. Any failure to handle higher volume of requests
for our products and services could lead to the loss of established clients and
have a material adverse effect on our business, results of operations and
financial condition. If we produce inaccurate test results, our
clients may choose not to use us in the future. This could severely
harm our business, results of operations and financial condition. In
addition, based on the importance of the subject matter of our tests, inaccurate
results could result in improper treatment of patients, and potential liability
for us.
We
May Fail to Protect Our Facilities, Which Could Have A Material Adverse Affect
On Our Business, Results Of Operations And Financial Condition
The
Company’s operations are dependent in part upon its ability to protect its
laboratory operations against physical damage from fire, floods, hurricanes,
earthquakes, power loss, telecommunications failures, break-ins and similar
events. The Company does not presently have an emergency back-up
generator in place at its Nashville, Tennessee or Irvine and Chatsworth,
California laboratory locations that can mitigate to some extent the effects of
a prolonged power outage. The occurrence of any of these events could
result in interruptions, delays or cessations in service to clients, which could
have a material adverse effect on our business, results of operations and
financial condition.
The
Steps Taken By The Company To Protect Its Proprietary Rights May Not Be
Adequate, Which Could Result In Infringement Or Misappropriation By
Third-Parties
We regard
our copyrights, trademarks, trade secrets and similar intellectual property as
critical to our success, and we rely upon trademark and copyright law, trade
secret protection and confidentiality and/or license agreements with our
employees, clients, partners and others to protect our proprietary
rights. The steps taken by us to protect our proprietary rights may
not be adequate or third parties may infringe or misappropriate our copyrights,
trademarks, trade secrets and similar proprietary rights. In
addition, other parties may assert infringement claims against us.
We
Are Dependent On Key Personnel And Need To Hire Additional Qualified Personnel
In Order For Our Business To Succeed
Our
performance is substantially dependent on the performance of our senior
management and key technical personnel. In particular, our success
depends substantially on the continued efforts of our senior management team,
which currently is composed of a small number of individuals. The
loss of the services of any of our executive officers, our laboratory directors
or other key employees could have a material adverse effect on our business,
results of operations and our financial condition. Our future success
also depends on our continuing ability to attract and retain highly qualified
technical and managerial personnel. Competition for such personnel is
intense and we may not be able to retain our key managerial and technical
employees or may not be able to attract and retain additional highly qualified
technical and managerial personnel in the future. The inability to
attract and retain the necessary technical and managerial personnel could have a
material adverse effect upon our business, results of operations and financial
condition.
The
Failure to Obtain Necessary Additional Capital To Finance Growth And Capital
Requirements, Could Adversely Affect Our Business, Financial Condition And
Results of Operations
We may
seek to exploit business opportunities that require more capital than we have
currently available. We may not be able to raise such capital on
favorable terms or at all. If we are unable to obtain such additional
capital, we may be required to reduce the scope of our anticipated expansion,
which could adversely affect our business, financial condition and results of
operations.
On
February 1, 2008, we entered into a revolving credit facility with CapitalSource
Finance, LLC (“CapitalSource”), which allows us to borrow up to $3,000,000 based
on a formula which is tied to our eligible accounts receivable that are aged
less than 150 days. On April 26, 2010, the CapitalSource facility was
amended and restated to allow us to borrow up to $5,000,000 against eligible
accounts receivable. As of March 31, 2010, we had cash and cash
equivalents of approximately $1,661,000, restricted cash of $1,000,000 and we
had approximately $552,000 of availability under this credit
facility. If we were unable to obtain sufficient working capital
financing from CapitalSource or sell enough of our products, we would need to
secure other sources of funding, including possibly equity financing, in order
to satisfy our working capital needs. This line expires on January
31, 2013, and we have the risk that it may not be renewed or a suitable
replacement found. The CapitalSource credit facility line has
financial covenants which are measured on a monthly basis and which must
continue to be met by the Company. We failed to meet our fixed charge
coverage ratio for the test periods ended January 31, 2010 and February 28, 2010
and received a waiver on March 26, 2010. In the event that we do not
continue to meet the requirements of such financial covenants or we otherwise
default on the terms of the CapitalSource credit facility and we are unable to
obtain a waiver of such default or obtain Capital Source’s agreement to amend
the facility, there is a risk that Capital Source could stop lending under the
facility and demand that all amounts outstanding under the facility be paid
immediately by the Company.
On
November 5, 2008, the Company and Fusion Capital entered into the Purchase
Agreement. We only have the right to receive $50,000 every four
business days under the Purchase Agreement unless our stock price equals or
exceeds $0.75, in which case we can sell greater amounts to Fusion
Capital as the price of our common stock increases. Fusion Capital
shall not have the right nor the obligation to purchase any shares of our common
stock on any business day that the market price of our common stock is less than
$0.45. Since we are registering 3,000,000 shares for sale under the
Purchase Agreement by Fusion Capital pursuant to the registration statement of
which this prospectus is a part, the selling price of our common stock to Fusion
Capital will have to average at least $2.67 per share for us to receive the
maximum proceeds of $8.0 million. Assuming a purchase price of $1.42
per share (the closing sale price of the common stock on April 27, 2010) and the
purchase by Fusion Capital of the full 3,000,000 shares under the Purchase
Agreement, proceeds to us would only be $4,260,000 unless we choose to register
more than 3,000,000 shares, which we have the right, but not the obligation, to
do. Subject to approval by our board of directors, we have the right
but not the obligation to sell more than 3,000,000 shares to Fusion
Capital. In the event we elect to sell more than 3,000,000 shares
offered hereby, we will be required to file a new registration statement and
have it declared effective by the U.S. Securities and Exchange Commission. The
extent we rely on Fusion Capital as a source of funding will depend on a number
of factors, including the prevailing market price of our common stock and the
extent to which we are able to secure working capital from other
sources. Specifically, Fusion Capital shall not have the right nor
the obligation to purchase any shares of our common stock on any business days
that the market price of our common stock is less than $0.45. If
obtaining sufficient financing from Fusion Capital were to prove unavailable or
prohibitively dilutive and if we are unable to sell enough of our products, we
will need to secure another source of funding in order to satisfy our working
capital needs.
Even if
we are able to access the full $5.0 million from CapitalSource and the full $8.0
million under the Purchase Agreement with Fusion Capital, we may still need
additional capital to fully implement our business, operating and development
plans. Should the financing we require to sustain our working capital
needs be unavailable or prohibitively expensive when we require it, there could
be a material adverse effect on our business, operating results, financial
condition and prospects.
Proposed
Government Regulation Of Laboratory Developed Tests (“LDT’s”) May Result In
Delays To Certain Laboratory Tests and Increase Our Costs To Implement New
Tests
We frequently develop testing
procedures to provide diagnostic results to tests that are not available using
Federal Drug Administration (“FDA”) approved methods. The FDA has
been considering changes to the way that laboratories are allowed to offer these
LDT’s. Currently all such tests are conducted and offered under
approval by CLIA and individual state licensing procedures: the FDA is
considering requiring FDA approval on a portion of those currently offered
non-FDA approved tests. There are currently no formal definitions,
procedures or FDA processes on how such approvals would be handled but there is
a risk that this could delay the offering of certain tests and result in
additional validation costs to us.
Steps
Taken By Government Payors, Such As Medicare And Medicaid To Control The
Utilization and Reimbursement Of Healthcare Services, Including Esoteric Testing
May Diminish Our Net Revenue
We face
efforts by government payers to reduce utilization as well as reimbursement for
laboratory testing services.
From time
to time, Congress has legislated formulas adverse to sustainable payment rates,
and has reduced, delayed, or modified updates to the Medicare Physician Fee
Schedule. The Physician Fee Schedule assigns relative value units to each
procedure or service, and a conversion factor is applied to calculate the
reimbursement. The Physician Fee Schedule is subject to adjustment on an annual
basis. The formula used to calculate the fee schedule conversion factor, known
as the Sustainable Growth Rate, would have resulted in significant decreases in
payment for most physician services for each year since 2003. However, since
that time Congress has intervened repeatedly to prevent these payment
reductions, and the conversion factor has been increased or frozen for the
subsequent year. Decreases in payment will occur in future years unless Congress
acts to change the formula used to calculate the fee schedule or continues to
legislate modifications to the Sustainable Growth Rate each year. In late 2008,
Congress acted to provide a 1.1% increase in physician fee schedule payments in
2009. The calendar year 2010 update to the conversion factor for the physician
fee schedule, based on the statutory formula, is a payment reduction of 21.2 %.
To temporarily prevent this reduction to the physician fee schedule, an
extension of the 2009 conversion factor through February 28, 2010 was included
in legislation enacted on December 19, 2009. However, legislation was enacted in
early March 2010 to delay the implementation of the reduction until September
30, 2010. In the event that the reduction in the Medicare physician
fee schedule is not further modified prospectively, either by statutory
intervention or by modifying the formula to determine the physician fee
schedule, the Company could face a material reduction in the Medicare
reimbursements it receives for certain of its laboratory tests. Reductions in
the Medicare physician fee schedule could have a material adverse effect on our
business, operating results, financial condition and prospects.
In
addition, certain other legislation expired on December 31, 2009 which
grandfathered the implementation of new reimbursement procedures for the
technical component of Medicare tests performed for certain hospital clients
(known as the “TC Grandfather” legislation). As a result of the
expiration of the TC Grandfather legislation, reference labs like the Company
could no longer bill Medicare directly for the technical component of laboratory
tests for grandfathered hospitals. However the recently enacted
Patient Protection and Affordable Care Act, HR 3590, extended the TC Grandfather
provision through December 31, 2010. In the event that the TC
Grandfather legislation is not further extended, the Company would be required
to bill the hospitals ordering such services for the technical component of
those tests the Company previously billed to Medicare. In such case,
there can be no assurance that the hospital clients of the Company will contract
to pay for such tests or will continue to order such tests from the Company in
the same volumes as they have been historically, which could have a material
adverse effect on our business, operating results, financial condition and
prospects.
CMS
adopts policies, from time to time, limiting or excluding coverage for certain
of the tests that we perform. Many state governments are under budget
pressures and are also considering reductions to their Medicaid
fees. Further, Medicare can perform audits for overutilization of
billed services. Even though all tests performed by us are ordered by
our clients, who establish the medical necessity for the tests, we may be
subject to recoupment of payments, as the recipient of Medicare payments for
such tests, in the event that CMS determines that the tests failed to meet all
applicable criteria for payment. When CMS revises its coverage
policies, our costs increase due to the complexity and additional administrative
requirements. Furthermore, Medicaid reimbursement and regulations vary by state,
and we are subject to varying administrative and billing regulations, which
affect the complexity of servicing such programs and our administrative
costs.
During
the last several years, the federal government has sponsored programs to expand
the number of Medicare beneficiaries participating in managed care programs,
called “Medicare Advantage” programs, and has encouraged such beneficiaries to
switch from the traditional fee for service Medicare program to Medicare
Advantage programs. There has been rapid growth of health insurance and managed
care plans offering Medicare Advantage programs and growth in beneficiary
enrollment in these programs. Also in recent years, many states have
increasingly mandated that Medicaid beneficiaries enroll in managed care
arrangements. If these efforts continue to be successful, we may experience a
further shift of traditional Medicare and Medicaid beneficiaries to managed care
programs. As a result, the Company would be required to contract with those
managed care programs. There can be no assurance that the managed care programs
and the Company will enter into agreements at rates of payment similar to those
the Company realizes from its non-managed care lines of business. Recently,
state budget pressures have encouraged states to consider several courses that
may impact our business, such as delaying payments, restricting coverage
eligibility, service coverage restrictions and imposing taxes on our
services.
We expect
these initiatives to continue and, if they do, to reduce reimbursements, to
impose more stringent cost controls and to reduce utilization of clinical test
services. These efforts, including changes in law or regulations that may occur
in the future, may have a material adverse impact on our business, operating
results, financial condition and prospects.
Our
Net Revenue Will Be Diminished If Payors Do Not Adequately Cover Or Reimburse
Our Services
There has
been and will continue to be significant efforts by both federal and state
agencies to reduce costs in government healthcare programs and otherwise
implement government control of healthcare costs. In addition, increasing
emphasis on managed care in the U.S. may continue to put pressure on the pricing
of healthcare services. Uncertainty exists as to the coverage and reimbursement
status of new applications or services. Third party payors, including
governmental payors such as Medicare and private payors, are scrutinizing new
medical products and services and may not cover or may limit coverage and the
level of reimbursement for our services. Third party insurance coverage may not
be available to patients for any of our existing tests or for tests we discover
and develop. In addition, a substantial portion of the testing for
which we bill our hospital and laboratory clients is ultimately paid by third
party payors. Any pricing pressure exerted by these third party
payors on our clients may, in turn, be exerted by our clients on
us. If government and other third party payors do not provide
adequate coverage and reimbursement for our tests, our operating results, cash
flows or financial condition may decline.
Third
Party Billing Is Extremely Complicated And Will Result In Significant Additional
Costs To Us
Billing
for laboratory services is extremely complicated. The customer refers the tests;
the payor is the party that pays for the tests, and the two are not usually the
same. Depending on the billing arrangement and applicable law, we need to bill
various payors, such as patients, insurance companies, Medicare, Medicaid,
doctors and employer groups, hospitals and other laboratories, all of which have
different billing requirements. Additionally, our billing relationships require
us to undertake internal audits to evaluate compliance with applicable laws and
regulations as well as internal compliance policies and procedures. Insurance
companies also impose routine external audits to evaluate payments made, which
adds further complexity to the billing process.
Among
others, the primary factors which complicate our billing practices
are:
• pricing
differences between our fee schedules and the reimbursement rates of the
payors;
• disputes
with payors as to which party is responsible for payment; and
• disparity
in coverage and information requirements among various carriers.
We incur
significant additional costs as a result of our participation in the Medicare
and Medicaid programs, as billing and reimbursement for clinical laboratory
testing are subject to considerable and complex federal and state regulations.
The additional costs we expect to incur include those related to: (1)
complexity added to our billing processes; (2) training and education of our
employees and clients; (3) implementing compliance procedures and oversight; (4)
collections and legal costs; and (5) costs associated with, among other factors,
challenging coverage and payment denials and providing patients with information
regarding claims processing and services, such as advanced beneficiary
notices.
Our
Operations Are Subject To Strict Laws Prohibiting Fraudulent Billing And Other
Abuse, And Our Failure To Comply With Such Laws Could Result In Substantial
Penalties
Of
particular importance to our operations are federal and state laws prohibiting
fraudulent billing and providing for the recovery of non-fraudulent
overpayments. A large number of laboratories have been forced by the
federal and state governments, as well as by private payors, to enter into
substantial settlements under these laws. In particular, if an entity is
determined to have violated the federal False Claims Act, it may be required to
pay up to three times the actual damages sustained by the government, plus civil
penalties of between $5,500 to $11,000 for each separate false claim. There are
many potential bases for liability under the federal False Claims Act. Liability
arises, primarily, when an entity knowingly submits, or causes another to
submit, a false claim for reimbursement to the federal government. Submitting a
claim with reckless disregard or deliberate ignorance of its truth or falsity
could also result in substantial civil liability. A trend affecting the
healthcare industry is the increased use of the federal False Claims Act and, in
particular, actions under the False Claims Act’s “whistleblower” or “qui tam”
provisions to challenge the reimbursement practices of providers and suppliers.
Those provisions allow a private individual to bring an action on behalf of the
government alleging that the defendant has submitted a fraudulent claim for
payment to the federal government. The government must decide whether to
intervene in the lawsuit and whether to prosecute the case. If it declines to do
so, the individual may pursue the case alone, although the government must be
kept apprised of the progress of the lawsuit. Whether or not the federal
government intervenes in the case, it will receive the majority of any recovery.
In addition, various states have enacted laws modeled after the federal False
Claims Act. Government investigations of clinical laboratories have
been ongoing for a number of years and are expected to continue in the
future.
On
November 9, 2009, the Company was notified by the Civil Division of the U.S.
Department of Justice (“DOJ”) that a “qui tam” complaint (“Complaint”) had been
filed under seal by a private individual against a number of health care
companies, including the Company. The Complaint is an action to recover damages
and civil penalties arising from alleged false or fraudulent claims and
statements submitted or caused to be submitted by the defendants to Medicare. As
of the date of the registration statement of which this prospectus is a part,
the DOJ had not made any decision whether to join the action. The Company
believes the allegations in the Complaint are without merit and intends to
vigorously defend itself if required to do so, however there can be no assurance
that if we are required to defend ourselves in this action, our operating
results, cash flows or financial condition will not be impacted.
The
Failure To Comply With Significant Government Regulation And Laboratory
Operations May Subject The Company To Liability, Penalties Or Limitation Of
Operations
As
discussed in the Government Regulation section of our business description, we
are subject to extensive state and federal regulatory oversight. Our
laboratory locations may not pass inspections conducted to ensure compliance
with CLIA or with any other applicable licensure or certification laws. The
sanctions for failure to comply with CLIA or state licensure requirements might
include the inability to perform services for compensation or the suspension,
revocation or limitation of the laboratory location’s CLIA certificate or state
license, as well as civil and/or criminal penalties. In addition, any
new legislation or regulation or the application of existing laws and
regulations in ways that we have not anticipated could have a material adverse
effect on the Company’s business, results of operations and financial
condition. Existing federal laws governing Medicare and Medicaid, as
well as some other state and federal laws, also regulate certain aspects of the
relationship between healthcare providers, including clinical and anatomic
laboratories, and their referral sources, including physicians, hospitals and
other laboratories. Certain provisions of these laws, known as the
"anti-kickback law" and the “Stark Laws”, contain extremely broad proscriptions.
Violation of these laws may result in criminal penalties, exclusion from
Medicare and Medicaid, and significant civil monetary penalties. We
seek to structure our arrangements with physicians and other clients to be in
compliance with the anti-kickback, Stark and state laws, and to keep up-to-date
on developments concerning their application by various means, including
consultation with legal counsel. However, we are unable to predict
how these laws will be applied in the future and the arrangements into which we
enter may become subject to scrutiny thereunder. Furthermore, the
Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), and other
state laws contain provisions that affect the handling of claims and other
patient information that are, or have been, transmitted electronically and
regulate the general disclosure of patient records and patient health
information. These provisions, which address security and confidentiality of
patient information as well as the administrative aspects of claims handling,
have very broad applicability and they specifically apply to healthcare
providers, which include physicians and clinical laboratories. Although we
believe we have complied with the Standards, Security and Privacy rules under
HIPAA and state laws, an audit of our procedures and systems could find
deficiencies. Such deficiencies, if found, could have a material
adverse effect on the Company’s business, results of operations and financial
condition and subject us to liability.
Our
Failure To Comply With Governmental Payor Regulations Could Result In Our Being
Excluded From Participation In Medicare, Medicaid Or Other Governmental Payor
Programs, Which Would Decrease Our Revenues And Adversely Affect Our Results Of
Operations And Financial Condition
Billable
tests which are reimbursable from Medicare and Medicaid accounted for
approximately 49% and 47% of our revenues for the years ended December 31, 2009
and 2008, respectively. The Medicare program imposes extensive and detailed
requirements on diagnostic services providers, including, but not limited to,
rules that govern how we structure our relationships with physicians, how and
when we submit reimbursement claims and how we provide our specialized
diagnostic services. Our failure to comply with applicable Medicare, Medicaid
and other governmental payor rules could result in our inability to participate
in a governmental payor program, our returning funds already paid to us for
services performed, civil monetary penalties, criminal penalties and/or
limitations on the operational function of our laboratory. If we were unable to
receive reimbursement under a governmental payor program, a substantial portion
of our revenues would be lost, which would adversely affect our results of
operations and financial condition.
Our
Business Could Be Harmed By Future Interpretations Of Clinical Laboratory
Mark-Up Prohibitions
Our
laboratory currently uses the services of outside reference laboratories to
provide certain complementary laboratory services to those services provided
directly by our laboratory. Although Medicare policies do not prohibit certain
independent-laboratory-to-independent-laboratory referrals and subsequent
mark-up for services, California and other states have rules and regulations
that prohibit or limit the mark-up of these laboratory-to-laboratory services. A
challenge to our charge-setting procedures under these rules and regulations
could have a material adverse effect on our business, results of operations and
financial condition.
Failure
To Comply With The HIPAA Security And Privacy Regulations May Increase Our
Operational Costs
The HIPAA privacy and security
regulations establish comprehensive federal standards with respect to the uses
and disclosures of Protected Health Information, (“PHI”), by health plans and
healthcare providers, in addition to setting standards to protect the
confidentiality, integrity and availability of electronic PHI. The regulations
establish a complex regulatory framework on a variety of subjects, including the
circumstances under which uses and disclosures of PHI are permitted or required
without a specific authorization by the patient, including but not limited to
treatment purposes, activities to obtain payments for services and health care
operations activities; a patient's rights to access, amend and receive an
accounting of certain disclosures of PHI; the content of notices of privacy
practices for PHI; and administrative, technical and physical safeguards
required of entities that use or receive PHI electronically. We have
implemented policies and procedures related to compliance with the HIPAA privacy
and security regulations, as required by law. The privacy regulations establish
a uniform federal "floor" and do not supersede state laws that may be more
stringent. Therefore, we are required to comply with both federal privacy
regulations and varying state privacy laws. The federal privacy regulations
restrict our ability to use or disclose patient identifiable laboratory data,
without patient authorization, for purposes other than payment, treatment or
healthcare operations (as defined by HIPAA), except for disclosures for various
public policy purposes and other permitted purposes outlined in the privacy
regulations. The privacy and security regulations provide for significant fines
and other penalties for wrongful use or disclosure of PHI, including potential
civil and criminal fines and penalties. Although the HIPAA statute and
regulations do not expressly provide for a private right of damages, we also
could incur damages under state laws to private parties for the wrongful use or
disclosure of confidential health information or other private personal
information.
Changes
In Regulations, Payor Policies Or Contracting Arrangements With Payors Or
Changes In Other Laws, Regulations Or Policies May Adversely Affect Coverage Or
Reimbursement For Our Specialized Diagnostic Services, Which May Decrease Our
Revenues And Adversely Affect Our Results Of Operations And Financial
Condition
Governmental
payors, as well as private insurers and private payors, have implemented and
will continue to implement measures to control the cost, utilization and
delivery of healthcare services, including clinical laboratory and pathology
services. Congress has considered, from time to time and has implemented changes
to laws and regulations governing healthcare service providers, including
specialized diagnostic service providers. These changes have adversely affected
and may in the future adversely affect coverage for our services. We
also believe that healthcare professionals will not use our services if third
party payors do not provide adequate coverage and reimbursement for them. These
changes in federal, state, local and third party payor regulations or policies
may decrease our revenues and adversely affect our results of operations and
financial condition. We will continue to be a non-contracting
provider until such time as we enter into contracts with third party payors with
whom we are not currently contracted. Because a portion of our
revenues is from third-party payors with whom we are not currently contracted,
it is likely that we will be required to make positive or negative adjustments
to accounting estimates with respect to contractual allowances in the future,
which may adversely affect our results of operations, our credibility with
financial analysts and investors, and our stock price.
We
Are Subject To Security Risks Which Could Harm Our Operations
Despite
the implementation of various security measures by us, our infrastructure is
vulnerable to computer viruses, break-ins and similar disruptive problems caused
by our clients or others. Computer viruses, break-ins or other
security problems could lead to interruption, delays or cessation in service to
our clients. Further, such break-ins whether electronic or physical
could also potentially jeopardize the security of confidential information
stored in our computer systems as it relates to clients and other parties
connected through us, which may deter potential clients and give rise to
uncertain liability to parties whose security or privacy has been
infringed. A significant security breach could result in loss of
clients, damage to our reputation, direct damages, costs of repair and
detection, and other expenses. The occurrence of any of the foregoing
events could have a material adverse effect on our business, results of
operations and financial condition.
We
Must Hire And Retain Qualified Sales Representatives To Grow Our
Sales
Our
ability to retain existing clients for our specialized diagnostic services and
attract new clients is dependent upon retaining existing sales representatives
and hiring new sales representatives, which is an expensive and time-consuming
process. We face intense competition for qualified sales personnel and our
inability to hire or retain an adequate number of sales representatives could
limit our ability to maintain or expand our business and increase sales. Even if
we are able to increase our sales force, our new sales personnel may not commit
the necessary resources or provide sufficient high quality service and attention
to effectively market and sell our services. If we are unable to maintain and
expand our marketing and sales networks or if our sales personnel do not perform
to our high standards, we may be unable to maintain or grow our existing
business and our results of operations and financial condition will likely
suffer accordingly. If a sales representative ceases employment, we risk the
loss of client goodwill based on the impairment of relationships developed
between the sales representative and the healthcare professionals for whom the
sales representative was responsible. This is particularly a risk if the
representative goes to work for a competitor, as the healthcare professionals
that are our clients may choose to use a competitor's services based on their
relationship with the departed sales representative.
Performance
Issues, Service Interruptions Or Price Increases By Our Shipping Carrier Could
Adversely Affect Our Business, Results Of Operations And Financial Condition,
And Harm Our Reputation And Ability To Provide Our Specialized Diagnostic
Services On A Timely Basis
Expedited,
reliable shipping is essential to our operations. One of our marketing
strategies entails highlighting the reliability of our point-to-point transport
of patient samples. We rely heavily on a single carrier, FedEx
Corporation, and also our local courier, for reliable and secure point-to-point
transport of patient samples to our laboratory and enhanced tracking of these
patient samples. Should FedEx encounter delivery performance issues
such as loss, damage or destruction of a sample, it may be difficult to replace
our patient samples in a timely manner and such occurrences may damage our
reputation and lead to decreased demand for our services and increased cost and
expense to our business. In addition, any significant increase in shipping rates
could adversely affect our operating margins and results of operations.
Similarly, strikes, severe weather, natural disasters or other service
interruptions by delivery services we use would adversely affect our ability to
receive and process patient samples on a timely basis. If FedEx or we were to
terminate our relationship, we would be required to find another party to
provide expedited, reliable point-to-point transport of our patient samples.
There are only a few other providers of such nationwide transport services, and
there can be no assurance that we will be able to enter into arrangements with
such other providers on acceptable terms, if at all. Finding a new provider of
transport services would be time-consuming and costly and result in delays in
our ability to provide our specialized diagnostic services. Even if we were to
enter into an arrangement with such provider, there can be no assurance that
they will provide the same level of quality in transport services currently
provided to us by FedEx. If the new provider does not provide the required
quality and reliable transport services, it could adversely affect our business,
reputation, results of operations and financial condition.
We
Use Biological And Hazardous Materials That Require Considerable Expertise And
Expense For Handling, Storage Or Disposal And May Result In Claims Against
Us
We work
with hazardous materials, including chemicals, biological agents and compounds,
blood samples and other human tissue that could be dangerous to human health and
safety or the environment. Our operations also produce hazardous and
biohazardous waste products. Federal, state and local laws and regulations
govern the use, generation, manufacture, storage, handling and disposal of these
materials and wastes. Compliance with applicable environmental laws and
regulations may be expensive, and current or future environmental laws and
regulations may impair business efforts. If we do not comply with applicable
regulations, we may be subject to fines and penalties. In addition,
we cannot entirely eliminate the risk of accidental injury or contamination from
these materials or wastes. Our general liability insurance and/or workers'
compensation insurance policy may not cover damages and fines arising from
biological or hazardous waste exposure or contamination. Accordingly, in the
event of contamination or injury, we could be held liable for damages or
penalized with fines in an amount exceeding our resources, and our operations
could be suspended or otherwise adversely affected.
Our
Ability To Comply With The Financial Covenants In Our Credit Agreements Depends
Primarily On Our Ability To Generate Substantial Operating Cash
Flow
Our
ability to comply with the financial covenants under our credit agreement with
CapitalSource will depend primarily on our success in generating substantial
operating cash flow. Our credit agreement contains numerous financial and other
restrictive covenants, including restrictions on purchasing and selling assets,
paying dividends to our shareholders, and incurring additional indebtedness. Our
failure to meet these covenants could result in a default and acceleration of
repayment of the indebtedness under our credit facility. If the maturity of our
indebtedness were accelerated, we may not have sufficient funds to pay such
indebtedness. In such event, our lenders would be entitled to proceed against
the collateral securing the indebtedness, which includes substantially our
entire accounts receivable, to the extent permitted by our credit agreements and
applicable law.
We
Have Potential Conflicts Of Interest Relating To Our Related Party Transactions
Which Could Harm Our Business
We have
potential conflicts of interest relating to existing agreements we have with
certain of our directors, officers, principal shareholders, shareholders and
employees. Potential conflicts of interest can exist if a related party director
or officer has to make a decision that has different implications for us and the
related party. If a dispute arises in connection with any of these agreements,
if not resolved satisfactorily to us, our business could be
harmed. There can be no assurance that the above or any future
conflicts of interest will be resolved in our favor. If not resolved, such
conflicts could harm our business.
We
Are Effectively Controlled By Existing Stockholders And Therefore Other
Stockholders Will Not Be Able To Direct The Company
Effective
voting control of the Company is held by a relatively small group of
stockholders. These stockholders effectively retain control of our
Board of Directors and determine all of our corporate actions. In
addition, the Company and stockholders owning and/or having the right to vote
11,197,901 shares, or approximately 30.4% of the Company’s voting shares
outstanding as of April 27, 2010, have executed a Shareholders’ Agreement that,
among other provisions, gives Aspen Select Healthcare, LP (“Aspen”), our largest
stockholder, the right to elect three out of the eight directors authorized for
our Board and nominate one mutually acceptable independent director and Dr.
Michael T. Dent, our founder, the right to nominate one
director. Accordingly, it is anticipated that Aspen and other parties
to the Shareholders’ Agreement will continue to have the ability to effectively
elect a controlling number of the members of our Board of
Directors. Such concentration of ownership may also have the effect
of delaying or preventing a change in control of the Company.
No
Foreseeable Dividends
We do not
anticipate paying dividends on our common stock in the foreseeable
future. Rather, we plan to retain earnings, if any, for the operation
and expansion of our business.
There
May Not Be A Viable Public Market For Our Common Stock
We cannot
predict the extent to which investor interest in our Company will sustain an
active trading market for our common stock on the OTC Bulletin Board or any
other stock market on which we may be listed or how liquid any such market might
remain. If an active public market is not sustained, it may be difficult for our
stockholders to sell their shares of common stock at a price that is attractive
to them, or at all.
We
May Become Involved In Securities Class Action Litigation That Could Divert
Management's Attention And Harm Our Business
The stock
markets have from time to time experienced significant price and volume
fluctuations that have affected the market prices for the common stock of
diagnostic companies. These broad market fluctuations may cause the market price
of our common stock to decline. In the past, securities class action litigation
has often been brought against a company following a decline in the market price
of its securities. This risk is especially relevant for us because clinical
laboratory service companies have experienced significant stock price volatility
in recent years. We may become involved in this type of litigation in
the future. Litigation often is expensive and diverts management's attention and
resources, which could adversely affect our business.
If
We Are Not The Subject Of Securities Analyst Reports Or If Any Securities
Analyst Downgrades Our Common Stock Or Our Sector, The Price Of Our Common Stock
Could Be Negatively Affected
Securities
analysts may publish reports about us or our industry containing information
about us that may affect the trading price of our common stock. There
are many publicly traded companies active in the healthcare industry, which may
mean it will be less likely that we receive analysts' coverage, which in turn
could affect the price of our common stock. In addition, if a securities or
industry analyst downgrades the outlook for our common stock or one of our
competitors' stocks or chooses to terminate coverage of our common stock, the
trading price of our common stock may also be negatively affected.
Risks
Related To This Offering
The
Sale Of Our Common Stock To Fusion Capital May Cause Dilution And The Sale Of
The Shares Of Common Stock Acquired By Fusion Capital Could Cause The Price Of
Our Common Stock To Decline
In
connection with entering into the Purchase Agreement, we authorized the sale to
Fusion Capital of up to 3,000,000 shares of our common stock. The
number of shares ultimately offered for sale by Fusion Capital under this
prospectus is dependent upon the number of shares purchased by Fusion Capital
under the Purchase Agreement. The purchase price for the common stock to be sold
to Fusion Capital pursuant to the Purchase Agreement will fluctuate based on the
price of our common stock. Specifically, under the Purchase Agreement
for purchases up to $50,000, the purchase price would be equal to the lesser of:
(i) the lowest sale price of the Company’s common stock on the purchase date; or
(ii) the average of the three lowest closing sale prices of the Company’s common
stock during the twelve consecutive business days prior to the date of a
purchase by Fusion Capital. The price at which the Company’s common
stock would be purchased for purchases in excess of $50,000 will be the lesser
of: (i) the lowest sale price of the Company’s common stock on the purchase date
and (ii) the lowest purchase price (as described above) during the previous
seven business days prior to the purchase date. Therefore, at the
time of our sales to Fusion Capital, it is likely that the purchase price to
Fusion Capital will be below the then market price.
All
3,417,500 shares registered in this offering related to the Fusion Capital
transaction are expected to be freely tradable. It is anticipated
that such shares will be sold over a period of up to 30 months from the date of
this prospectus. Depending upon market liquidity at the time, a sale
of shares under this offering at any given time could cause the trading price of
our common stock to decline. Fusion Capital may ultimately purchase
all, some or none of the 3,000,000 shares of common stock not yet issued but
registered in this offering. Such shares may be sold by us to Fusion
Capital at a sale price below the then market price of our shares which would be
dilutive to the value of shares held by our other shareholders.
After
Fusion Capital has acquired such shares, it may sell all, some or none of such
shares. Under the Purchase Agreement, we have the right but not the obligation
to sell more than the 3,000,000 shares to Fusion Capital. As of the
date hereof, we do not currently have any plans or intent to sell to Fusion
Capital any shares beyond the 3,000,000 shares offered
hereby. However, if we elect to sell more than the 3,000,000 shares
(which we have the right but not the obligation to do), we must first register
such additional shares under the Securities Act before we can elect to sell such
additional shares to Fusion Capital. In the event we elect to do so,
this could cause substantial dilution to the ownership interests of our
shareholders. The number of shares ultimately offered for sale by
Fusion Capital is dependent upon the number of shares purchased by Fusion
Capital under the Purchase Agreement. Moreover, the sale of a substantial number
of shares of our common stock under this offering, or anticipation of such
sales, could make it more difficult for us to sell equity or equity-related
securities in the future at a time and at a price that we might otherwise wish
to effect sales. However, we have the right to control the timing and
amount of any sales of our shares to Fusion Capital and the Purchase Agreement
may be terminated by us at any time at our discretion without any further cost
to us.
Future
Sales By Our Stockholders May Adversely Affect Our Stock Price And Our Ability
To Raise Funds In New Stock Offerings
Sales of
our common stock in the public market following this offering could lower the
market price of our common stock. Sales may also make it more difficult for us
to sell equity securities or equity-related securities in the future at a time
and price that our management deems acceptable or at all. Of the
37,278,768 shares of common stock outstanding as of April 27, 2010
26,842,462 shares are freely tradable without restriction, unless held by our
“affiliates”. The remaining 10,436,205 shares of our common stock
which are held by existing stockholders, including the officers and directors,
are “restricted securities” and may be resold in the public market only if
registered or pursuant to an exemption from registration. Some of these shares
may be resold under Rule 144.
The
Selling Stockholders May Sell Their Shares Of Common Stock In The Market, Which
Sales May Cause Our Stock Price To Decline
The
selling stockholders may sell in the public market 6,500,000 shares of our
common stock being registered in this offering. That means that up to 6,500,000
shares may be sold pursuant to this prospectus. Such sales may cause our stock
price to decline.
The
Price You Pay In This Offering Will Fluctuate And May Be Higher Or Lower Than
The Prices Paid By Other People Participating In This Offering
The price
in this offering will fluctuate based on the prevailing market price of our
common stock on the OTCBB. Accordingly, the price you pay in this
offering may be higher or lower than the prices paid by other people
participating in this offering.
The
Market Price Of Our Common Stock Is Highly Volatile
The
market price of our common stock has been and is expected to continue to be
highly volatile. Factors, including announcements of technological innovations
by us or other companies, regulatory matters, new or existing products or
procedures, concerns about our financial position, operating results,
litigation, government regulation, developments or disputes relating to
agreements, patents or proprietary rights, may have a significant impact on the
market price of our common stock. In addition, potential dilutive effects of
future sales of shares of common stock by stockholders and by the Company,
including Fusion Capital and the other selling stockholders pursuant to this
prospectus, and subsequent sale of common stock by the holders of warrants and
options could have an adverse effect on the market price of our
shares.
If
Penny Stock Regulations Impose Restrictions On The Marketability Of Our Common
Stock, The Ability Of Our Stockholders To Sell Shares Of Our Stock Could Be
Impaired
The SEC
has adopted regulations that generally define a "penny stock" to be an equity
security that has a market price of less than $5.00 per share or an exercise
price of less than $5.00 per share subject to certain exceptions. Exceptions
include equity securities issued by an issuer that has (i) net tangible assets
of at least $2,000,000, if such issuer has been in continuous operation for more
than three years, or (ii) net tangible assets of at least $5,000,000, if such
issuer has been in continuous operation for less than three years, or (iii)
average revenue of at least $6,000,000 for the preceding three years. Our common
stock is currently trading at under $5.00 per share. Although we currently fall
under one of the exceptions, if at a later time we fail to meet one of the
exceptions, our common stock will be considered a penny
stock. Broker/dealers dealing in penny stocks are required to provide
potential investors with a document disclosing the risks of penny stocks.
Moreover, broker/dealers are required to determine whether an investment in a
penny stock is a suitable investment for a prospective investor. These
requirements, among others, may reduce the potential market for our common stock
by reducing the number of potential investors. This may make it more difficult
for investors in our common stock to resell shares to third parties or to
otherwise dispose of them. This could cause our stock price to
decline.
FORWARD-LOOKING
STATEMENTS
Information
included or incorporated by reference in this prospectus may contain
forward-looking statements. This information may involve known and unknown
risks, uncertainties and other factors which may cause our actual results,
performance or achievements to be materially different from the future results,
performance or achievements expressed or implied by any forward-looking
statements. Forward-looking statements, which involve assumptions and describe
our future plans, strategies and expectations, are generally identifiable by use
of the words “may”, “should”, “expect”, “anticipate”, “estimate”, “believe”,
“intend” or “project” or the negative of these words or other variations on
these words or comparable terminology.
This
prospectus contains forward-looking statements, including statements regarding,
among other things, (a) our projected sales and profitability, (b) our growth
strategies, (c) anticipated trends in our industry, (d) our future financing
plans and (e) our anticipated needs for working capital. These statements may be
found under “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” and “Description of Business”, as well as in this
prospectus generally. Actual events or results may differ materially from those
discussed in forward-looking statements as a result of various factors,
including, without limitation, the risks outlined under “Risk Factors” and
matters described in this prospectus generally. In light of these risks and
uncertainties, there can be no assurance that the forward-looking statements
contained in this prospectus will in fact occur.
SELLING
STOCKHOLDERS
The
following table presents information regarding our selling stockholders who
intend to sell up to 6,500,000 shares of our common
stock.
|
|
Shares Beneficially
Owned Before
Offering(1)
|
|
|
Percentage of
Outstanding
Shares
Beneficially
Owned Before
Offering(1)
|
|
|
Shares To Be
Sold In The
Offering
|
|
|
Percentage of
Outstanding
Shares
Beneficially
Owned After The
Offering
|
|
Fusion
Capital Fund II, LLC(2)
|
|
|
417,500 |
|
|
|
1.1
|
% |
|
|
3,417,500 |
|
|
|
0.0
|
% |
Aspen
Select Healthcare, LP(3)
|
|
|
11,666,155 |
|
|
|
28.9
|
% |
|
|
2,130,364 |
|
|
|
20.6
|
% |
Mary
S. Dent(4)
|
|
|
2,489,162 |
|
|
|
6.6
|
% |
|
|
553,488 |
|
|
|
4.4
|
% |
Steven
C. Jones(5)
|
|
|
12,786,362 |
|
|
|
31.4
|
% |
|
|
238,826 |
|
|
|
22.0
|
% |
Jones
Network, LP(6)
|
|
|
107,143 |
|
|
|
* |
|
|
|
107,143 |
|
|
|
0.0
|
% |
Marvin
E. Jaffe(7)
|
|
|
96,429 |
|
|
|
* |
|
|
|
21,429 |
|
|
|
* |
|
Steven
C. Jones ROTH IRA(8)
|
|
|
16,422 |
|
|
|
* |
|
|
|
18,750 |
|
|
|
* |
|
Peter
M. Peterson(9)
|
|
|
11,978,900 |
|
|
|
29.6
|
% |
|
|
12,500 |
|
|
|
21.2
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total(10):
|
|
|
15,889,453 |
|
|
|
38.3
|
% |
|
|
6,500,000 |
|
|
|
29.8
|
% |
*
|
Less
than one percent (1%).
|
(1)
|
Applicable
percentage of ownership is based on 37,278,667 shares of our common stock
outstanding as of April 27, 2010, together with securities exercisable or
convertible into shares of common stock within sixty (60) days of April
27, 2010, for each stockholder. Beneficial ownership is
determined in accordance with the rules of the SEC and generally includes
voting or investment power with respect to securities. Shares
of common stock are deemed to be beneficially owned by the person holding
such securities for the purpose of computing the percentage of ownership
of such person, but are not treated as outstanding for the purpose of
computing the percentage ownership of any other person. Note
that affiliates are subject to Rule 144 and insider trading regulations -
percentage computation is for form purposes
only.
|
(2)
|
Steven
G. Martin and Joshua B. Scheinfeld, the principals of Fusion Capital, are
deemed to be beneficial owners of all of the shares of common stock owned
by Fusion Capital. Messrs. Martin and Scheinfeld have shared voting and
disposition power over the shares being offered under this
prospectus. As of the date hereof, 417,500 shares of our common
stock have been previously acquired by Fusion Capital, consisting of
400,000 shares we issued to Fusion Capital as a commitment fee and 17,500
shares that were issued as an expense reimbursement. The
Company may elect in its sole discretion to sell to Fusion Capital up to
an additional 3,000,000 shares under the Purchase Agreement. Fusion
Capital does not presently beneficially own those shares as determined in
accordance with the rules of the
SEC.
|
(3)
|
Aspen
Select Healthcare, LP (“Aspen”) has
direct ownership of 5,905,279 shares and has certain warrants to purchase
3,050,000 shares, all of which are exercisable within 60 days of April 27,
2010. Also includes 2,710,876 shares to which Aspen has
received a voting proxy. The general partner of Aspen is
Medical Venture Partners, LLC, an entity controlled by Steven C. Jones and
Peter M. Peterson.
|
(4)
|
Mary
S. Dent is the spouse of Dr. Michael T. Dent, our chairman and
founder. Mrs. Dent has direct ownership of 1,016,170 shares
which she received in a spousal transfer from Dr. Dent in February
2007. Mrs. Dent’s beneficial ownership also includes (i)
900,000 shares held in a trust for the benefit of Dr. Dent’s children (of
which Dr. Dent and his attorney are the sole trustees), and (ii) warrants
and options held by Dr. Dent which are exercisable within sixty days of
April 27, 2010 to purchase 572,992
shares.
|
(5)
|
Steven
C. Jones, Executive Vice President - Finance and director of the Company,
has direct ownership of 391,164 shares and warrants exercisable within 60
days of April 27, 2010 to purchase an additional 127,298
shares. Totals for Mr. Jones also include (i) 129,412 shares
owned by Aspen Opportunity Fund, LP, an investment
partnership that Mr. Jones and Mr. Peterson control, (ii)
107,143 shares owned by Jones Network, LP, a family limited partnership
that Mr. Jones controls, (iii) warrants exercisable within 60 days of
April 27, 2010 to purchase 250,000 shares, that are owned by Aspen Capital
Advisors, LLC, a company that Mr. Jones controls, (iv) warrants
exercisable within 60 days of April 27, 2010 to purchase 83,333 shares
that are owned by Gulf Pointe Capital, LLC, a company that Mr. Jones and
Mr. Peterson control, and (v) 31,857 shares held in certain individual
retirement and custodial accounts. In addition, as a managing
member of the general partner of Aspen, he has the right to vote all
shares controlled by Aspen, thus all shares and currently exercisable
warrants owned by Aspen have been added to his total (see Note
3).
|
(6)
|
Jones
Network, LP is a family limited partnership controlled by Steven C.
Jones. The shares to be sold in this offering were received in
a distribution from Aspen.
|
(7)
|
Marvin
Jaffe, M.D. is a director of the Company. Dr. Jaffe’s
beneficial ownership includes 21,429 shares and warrants to purchase
75,000 shares which are exercisable within 60 days of April 27,
2010.
|
(8)
|
The
shares being sold in this offering were received in a distribution from
Aspen.
|
(9)
|
Peter
M. Peterson, a director of the Company, has direct ownership of warrants
exercisable within 60 days of April 27, 2010 to purchase 100,000
shares. In addition, as a managing member of the general
partner of Aspen, he has the right to vote all shares controlled by Aspen,
thus all Aspen shares and currently exercisable warrants have been added
to his total (see Note 3). Mr. Peterson’s beneficial ownership
also includes (i) warrants exercisable within 60 days of April 27, 2010 to
purchase an additional 83,333 shares that are owned by Gulf Pointe
Capital, LLC, a company that Mr. Jones and Mr. Peterson control, and (ii)
129,412 shares owned by Aspen Opportunity Fund, LP, an investment
partnership that Mr. Jones and Mr. Peterson
control.
|
(10)
|
The
total number of shares listed does not double count the shares that may be
beneficially attributable to more than one
person.
|
THE
FUSION TRANSACTION
General
On
November 5, 2008, the Company and Fusion Capital Fund II, LLC, an Illinois
limited liability company (“Fusion Capital”),
entered into a Common Stock Purchase Agreement (the “Purchase Agreement”),
and a Registration Rights Agreement (the “Registration Rights
Agreement”). Under the Purchase Agreement, Fusion Capital is
obligated, under certain conditions, to purchase shares from us in an aggregate
amount of $8.0 million from time to time over a thirty (30) month
period. Under the terms of the Purchase Agreement, Fusion Capital has
received a commitment fee consisting of 400,000 shares of our common
stock. As of April 27, 2010, there were 37,278,667 shares outstanding
26,842,462 shares held by non-affiliates) excluding the 3,000,000 shares offered
by Fusion Capital pursuant to this prospectus which it has not yet purchased
from us. If all of such 3,000,000 shares offered hereby were issued
and outstanding as of the date hereof, the 3,000,000 shares would represent 7.4%
of the total common stock outstanding or 11.2% of the non-affiliates shares
outstanding as of the date hereof.
Under the
Purchase Agreement and the Registration Rights Agreement we are required to
register and have included in the offering pursuant to this prospectus (1)
400,000 shares which have already been issued as a commitment fee, (2) 17,500
shares which we have issued to Fusion Capital as an expense reimbursement and
(3) at least 3,000,000 shares which we may sell to Fusion Capital in the
future. All 3,417,500 shares, 10.6% of our outstanding on November 5,
2008, the date of the Purchase Agreement, are being offered pursuant to this
prospectus. Under the Purchase Agreement, we have the right but not
the obligation to sell more than the 3,000,000 shares to Fusion
Capital. As of the date hereof, we do not currently have any plans or
intent to sell to Fusion Capital any shares beyond the 3,000,000 shares offered
hereby. However, if we elect to sell more than the 3,000,000 shares
(which we have the right but not the obligation to do), we must first register
such additional shares under the Securities Act before we can elect to sell such
additional shares to Fusion Capital. In the event we elect to do so,
this could cause substantial dilution to our shareholders. The number
of shares ultimately offered for sale by Fusion Capital is dependent upon the
number of shares purchased by Fusion Capital under the Purchase
Agreement.
We do not
have the right to commence any sales of our shares to Fusion Capital until the
SEC has declared effective the registration statement of which this prospectus
is a part. The registration statement was declared effective on
February 5, 2009 and the conditions to commence funding were
satisfied. Generally, we have the right but not the obligation from
time to time to sell our shares to Fusion Capital in amounts between $50,000 and
$1.0 million depending on certain conditions. We have the right to
control the timing and amount of any sales of our shares to Fusion
Capital. The purchase price of the shares will be determined based
upon the market price of our shares without any fixed discount at the time of
each sale. Fusion Capital shall not have the right nor the obligation
to purchase any shares of our common stock on any business day that the price of
our common stock is below $0.45. There are no negative covenants,
restrictions on future fundings, penalties or liquidated damages in the Purchase
Agreement or the Registration Rights Agreement. The Purchase
Agreement may be terminated by us at any time at our discretion without any cost
to us. The Purchase Agreement provides that neither party has the
ability to amend the Purchase Agreement and the obligations of both parties are
non-transferable.
Purchase
Of Shares Under The Purchase Agreement
Under the
Purchase Agreement, on any business day selected by us, we may direct Fusion
Capital to purchase up to $50,000 of our common stock. The purchase
price per share is equal to the lesser of:
|
•
|
the
lowest sale price of our common stock on the purchase date;
or
|
|
•
|
the
average of the three lowest closing sale prices of our common stock during
the twelve consecutive business days prior to the date of a
purchase by Fusion Capital.
|
The
purchase price will be equitably adjusted for any reorganization,
recapitalization, non-cash dividend, stock split, or other similar transaction
occurring during the business days used to compute the purchase price. We may
direct Fusion Capital to make multiple purchases from time to time in our sole
discretion; no sooner than every four business days.
Our
Right To Increase the Amount to be Purchased
In addition to purchases of up to
$50,000 from time to time, we may also from time to time elect on any single
business day selected by us to require Fusion Capital to purchase our shares in
an amount up to $100,000 provided that our share price is not below $0.75 during
the three business days prior to and on the purchase date. We may
increase this amount to up to $250,000 if our share price is not below $1.20
during the three business days prior to and on the purchase
date. This amount may also be increased to up to $500,000 if our
share price is not below $2.40 during the three business days prior to and on
the purchase date. This amount may also be increased to up to $1.0
million if our share price is not below $5.00 during the three business days
prior to and on the purchase date. We may direct Fusion Capital to
make multiple large purchases from time to time in our sole discretion; however,
at least two business days must have passed since the most recent large purchase
was completed. The price at which our common stock would be purchased
in this type of larger purchases will be the lesser of (i) the lowest sale price
of our common stock on the purchase date and (ii) the lowest purchase price (as
described above) during the previous seven business days prior to the purchase
date.
Minimum
Purchase Price
Under the
Purchase Agreement, we have set a minimum purchase price (“floor price”) of
$0.45. However, Fusion Capital shall not have the right nor the
obligation to purchase any shares of our common stock in the event that the
purchase price would be less the floor price. Specifically, Fusion Capital shall
not have the right or the obligation to purchase shares of our common stock on
any business day that the market price of our common stock is below
$0.45.
Events
of Default
Generally,
Fusion Capital may terminate the Purchase Agreement without any liability or
payment to the Company upon the occurrence of any of the following events of
default:
|
•
|
the
effectiveness of the registration statement of which this prospectus is a
part of lapses for any reason (including, without limitation, the issuance
of a stop order) or is unavailable to Fusion Capital for sale of our
common stock offered hereby and such lapse or unavailability continues for
a period of 20 consecutive business days or for more than an aggregate of
60 business days in any 365-day
period;
|
|
•
|
suspension
by our principal market of our common stock from trading for a period of
three consecutive business days;
|
|
•
|
the
de-listing of our common stock from our principal market provided our
common stock is not immediately thereafter trading on the American Stock
Exchange, the Nasdaq Global Market, the Nasdaq Capital Market, the Nasdaq
Global Select Market or the New York Stock
Exchange;
|
|
•
|
the
transfer agent‘s failure for five business days to issue to Fusion Capital
shares of our common stock which Fusion Capital is entitled to under the
Purchase Agreement;
|
|
•
|
any
material breach of the representations or warranties or covenants
contained in the Purchase Agreement or any related agreements which has or
which could have a material adverse effect on us subject to a cure period
of five business days;
|
|
•
|
any
participation or threatened participation in insolvency or bankruptcy
proceedings by or against us; or
|
|
•
|
a
material adverse change in our
business.
|
Our
Termination Rights
We have
the unconditional right at any time for any reason to give notice to Fusion
Capital terminating the Purchase Agreement without any cost to us.
No
Short-Selling or Hedging by Fusion Capital
Fusion
Capital has agreed that neither it nor any of its affiliates shall engage in any
direct or indirect short-selling or hedging of our common stock during any time
prior to the termination of the Purchase Agreement.
Effect
of Performance of the Purchase Agreement on Our Stockholders
All 3,417,500 shares registered in this
offering are expected to be freely tradable. It is anticipated that
shares registered in this offering will be sold over a period of up to 30 months
from the date of this prospectus. The sale by Fusion Capital of a
significant amount of shares registered in this offering at any given time could
cause the market price of our common stock to decline and to be highly
volatile. Fusion Capital may ultimately purchase all, some or none of
the 3,000,000 shares of common stock not yet issued but registered in this
offering. After it has acquired such shares, it may sell all, some or
none of such shares. Therefore, sales to Fusion Capital by us under the Purchase
Agreement may result in substantial dilution to the interests of other holders
of our common stock. However, we have the right to control the timing and amount
of any sales of our shares to Fusion Capital and the Purchase Agreement may be
terminated by us at any time at our discretion without any cost to
us.
In
connection with entering into the Purchase Agreement, we authorized the sale to
Fusion Capital of up to 3,000,000 shares of our common stock or 9.3% of our outstanding
common stock on November 5, 2008 (the date of the Purchase
Agreement). We estimate that we will sell no more than 3,000,000
shares to Fusion Capital under the Purchase Agreement all of which are included
in this offering. We have the right to terminate the Purchase
Agreement without any payment or liability to Fusion Capital at any time,
including in the event that all 3,000,000 shares are sold to Fusion Capital
under the Purchase Agreement. Subject to approval by our board of
directors, we have the right but not the obligation to sell more than 3,000,000
shares to Fusion Capital. In the event we elect to sell more than the
3,000,000 shares offered hereby, we will be required to file a new registration
statement and have it declared effective by the U.S. Securities and Exchange
Commission. The number of shares ultimately offered for sale by
Fusion Capital under this prospectus is dependent upon the number of shares
purchased by Fusion Capital under the Purchase Agreement. The
following table sets forth the amount of proceeds we would receive from Fusion
Capital from the sale of shares at varying purchase prices:
|
Assumed
Average
Purchase Price
|
|
|
Number of Shares to be Sold if Full
Purchase
|
|
|
Percentage of
Outstanding Shares After
Giving Effect to the
Issuance to Fusion
Capital(1)
|
|
|
Proceeds from the Sale of
Shares
to Fusion Capital Under the
Purchase Agreement
|
|
|
$ |
0.45 |
|
|
|
3,000,000 |
|
|
|
8.0 |
% |
|
$ |
1,350,000 |
|
|
$ |
1.42 |
(2) |
|
|
3,000,000 |
|
|
|
8.0 |
% |
|
$ |
4,260,000 |
|
|
$ |
1.50 |
|
|
|
3,000,000 |
|
|
|
8.0 |
% |
|
$ |
4,500,000 |
|
|
$ |
2.00 |
|
|
|
3,000,000 |
|
|
|
8.0 |
% |
|
$ |
6,000,000 |
|
|
$ |
2.50 |
|
|
|
3,000,000 |
|
|
|
8.0 |
% |
|
$ |
7,500,000 |
|
|
$ |
2.67 |
|
|
|
3,000,000 |
|
|
|
8.0 |
% |
|
$ |
8,000,000 |
|
|
(1)
|
The
denominator is based on 37,278,667 shares outstanding as of April 27,
2010, which includes the 417,500 shares previously issued to Fusion
Capital. The numerator is based on the number of shares issuable under the
Purchase Agreement at the corresponding assumed purchase price set forth
in the adjacent column.
|
|
(2)
|
Closing
sale price of our shares on April 27,
2010.
|
USE
OF PROCEEDS
This
prospectus relates to shares of our common stock that may be offered and sold
from time to time by the selling stockholders. We will receive no
proceeds from the sale of shares of common stock in this
offering. However, we may receive up to $8.0 million in proceeds from
the sale of our common stock to Fusion Capital under the Purchase
Agreement. Any proceeds from Fusion Capital we receive under the
Purchase Agreement will be used for working capital and general corporate
purposes.
PLAN
OF DISTRIBUTION
The
common stock offered by this prospectus is being offered by the selling
stockholders. The common stock may be sold or distributed from time
to time by the selling stockholders directly to one or more purchasers or
through brokers, dealers, or underwriters who may act solely as agents at market
prices prevailing at the time of sale, at prices related to the prevailing
market prices, at negotiated prices, or at fixed prices, which may be
changed. The sale of the common stock offered by this prospectus may
be effected in one or more of the following methods:
|
•
|
ordinary
brokers’ transactions;
|
|
•
|
transactions
involving cross or block trades;
|
|
•
|
through
brokers, dealers, or underwriters who may act solely as
agents
|
|
•
|
“at
the market” into an existing market for the common
stock;
|
|
•
|
in
other ways not involving market makers or established business markets,
including direct sales to purchasers or sales effected through
agents;
|
|
•
|
in
privately negotiated transactions;
or
|
|
•
|
any
combination of the foregoing.
|
In order
to comply with the securities laws of certain states, if applicable, the shares
may be sold only through registered or licensed brokers or
dealers. In addition, in certain states, the shares may not be sold
unless they have been registered or qualified for sale in the state or an
exemption from the registration or qualification requirement is available and
complied with.
Brokers,
dealers, underwriters, or agents participating in the distribution of the shares
as agents may receive compensation in the form of commissions, discounts, or
concessions from the selling stockholders and/or purchasers of the common stock
for whom the broker-dealers may act as agent. The compensation paid
to a particular broker-dealer may be less than or in excess of customary
commissions.
One of
the selling stockholders, Fusion Capital, is an “underwriter” within the meaning
of the Securities Act.
Neither
we nor the selling stockholders can presently estimate the amount of
compensation that any agent will receive. We know of no existing
arrangements between the selling stockholders, any other stockholder, broker,
dealer, underwriter, or agent relating to the sale or distribution of the shares
offered by this prospectus. At the time a particular offer of shares
is made, a prospectus supplement, if required, will be distributed that will set
forth the names of any agents, underwriters, or dealers and any compensation
from the selling stockholders, and any other required information.
We will
pay all expenses incident to the registration, offering, and sale of the shares
to the public other than commissions or discounts of underwriters,
broker-dealers, or agents. We have also agreed to indemnify certain
selling stockholders, including Fusion Capital, and related persons against
specified liabilities, including liabilities under the Securities
Act.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers, and controlling persons, we have been
advised that in the opinion of the SEC this indemnification is against public
policy as expressed in the Securities Act and is, therefore,
unenforceable.
Fusion
Capital and its affiliates have agreed not to engage in any direct or indirect
short selling or hedging of our common stock during the term of the Purchase
Agreement.
We have
advised the selling stockholders that while they are engaged in a distribution
of the shares included in this prospectus they are required to comply with
Regulation M promulgated under the Securities Exchange Act of 1934, as
amended. With certain exceptions, Regulation M precludes the selling
stockholders, any affiliated purchasers, and any broker-dealer or other person
who participates in the distribution from bidding for or purchasing, or
attempting to induce any person to bid for or purchase any security which is the
subject of the distribution until the entire distribution is
complete. Regulation M also prohibits any bids or purchases made in
order to stabilize the price of a security in connection with the distribution
of that security. All of the foregoing may affect the marketability of the
shares offered by this prospectus.
This
offering will terminate on the date that all shares offered by this prospectus
have been sold by the selling stockholders.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion and analysis should be read in conjunction with the
Consolidated Financial Statements, and the Notes thereto included herein. The
information contained below includes statements of management’s beliefs,
expectations, hopes, goals and plans that, if not historical, are
forward-looking statements subject to certain risks and uncertainties that could
cause actual results to differ materially from those anticipated in the
forward-looking statements. See “Forward-Looking Statements.” Our
actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including those
discussed below and elsewhere in this prospectus, particularly under the heading
“Risk Factors.”.
Overview
NeoGenomics
operates a network of cancer-focused testing laboratories whose mission is to
improve patient care through exceptional cancer genetic diagnostic, prognostic
and predictive testing services. Our vision is to become America’s premier
cancer testing laboratory by delivering uncompromising quality, exceptional
service and innovative products and solutions. The Company’s laboratory network
currently offers the following types of testing services:
|
a)
|
cytogenetics
testing, which analyzes human
chromosomes;
|
|
b)
|
Fluorescence
In-Situ Hybridization (“FISH”) testing, which analyzes abnormalities at
the chromosomal and gene levels;
|
|
c)
|
flow
cytometry testing, which analyzes gene expression of specific markers
inside cells and on cell surfaces;
|
|
d)
|
immunohistochemistry
testing, which analyzes the distribution of tumor antigens in specific
cell and tissue types, and
|
|
e)
|
molecular
testing which involves analysis of DNA and RNA to diagnose and predict the
clinical significance of various genetic sequence
disorders.
|
All of
these testing services are widely utilized in the diagnosis, prognosis, and
prediction for response to therapy of various types of cancers.
Market
Opportunity
The
medical testing laboratory market can be broken down into three primary
segments:
• clinical
lab testing,
• anatomic
pathology testing, and
• genetic
and molecular testing.
Clinical
laboratories are typically engaged in high volume, highly automated, lower
complexity tests on easily procured specimens such as blood and
urine. Clinical lab tests often involve testing of a less urgent
nature, for example, cholesterol testing and testing associated with routine
physical exams.
Anatomic
pathology (“AP”) testing involves evaluation of tissue, as in surgical
pathology, or cells as in cytopathology. The most widely performed AP
procedures include the preparation and interpretation of pap smears, skin
biopsies, and tissue biopsies.
Genetic
and molecular testing typically involves analyzing chromosomes, genes or DNA/RNA
sequences for abnormalities. New tests are being developed at an
accelerated pace, thus this market niche continues to expand
rapidly. Genetic and molecular testing requires highly specialized
equipment and credentialed individuals (typically MD or PhD level) to certify
results and typically yields the highest reimbursement levels of the three
market segments.
The
market for cancer testing is growing rapidly. Key factors influencing
this growth are: (i) cancer is primarily a disease of the elderly and
now that the baby boomer generation has started to turn sixty, the U.S. is
experiencing a significant increase in the number of senior citizens, (ii) the
American Cancer Society estimates that one in four senior citizens will develop
some form of cancer during the rest of their lifetime, and (iii) every year more
and more genes are discovered to have a specific link to cancer, which then
enables a genetic or molecular test to be developed. We
estimate that the Company addresses a $5-6 billion total United States market
opportunity, about half of which is derived from genetic and molecular testing
with the other half derived from more traditional anatomic pathology testing
services that are complementary to and often ordered with the genetic testing
services we offer.
Our
Focus
NeoGenomics’
primary focus is to provide high complexity laboratory testing for
community-based pathology, oncology, dermatology and urology markets in the
United States and the Caribbean. We focus on community-based practitioners for
two reasons: First, academic pathologists and associated clinicians tend to have
their testing needs met within the confines of their university affiliation.
Secondly, most of the cancer care in the United States is administered by
community based practitioners due to ease of local access. We currently provide
our services to pathologists and oncologists that perform bone marrow and/or
peripheral blood sampling for the diagnosis of blood and lymphoid tumors
(leukemias and lymphomas) and archival tissue referred for analysis of solid
tumors such as breast cancer. We also serve community-based urologists by
providing a FISH-based genetic test for the diagnosis of bladder cancer and
early detection of recurrent disease.
The high
complexity cancer testing services we offer to community-based pathologists are
designed to be a natural extension of and complementary to the services that our
pathologist clients perform within their own practices. Because fee-for-service
pathologists derive a significant portion of their annual revenue from the
interpretation of cancer biopsy specimens, they represent an important market
segment to us. We believe our relationship as a non-competitive partner to the
community-based pathologist empowers these pathologists to expand their testing
breadth and provide a menu of services that matches or exceeds the level of
service found in academic centers of excellence around the country.
We also
believe that we can provide a competitive choice to those larger oncology
practices that prefer to have a direct relationship with a laboratory for cancer
genetic testing services. Our regionalized approach allows us strong
interactions with clients and our innovative Genetic Pathology Solutions (“GPS”)
report summarizes all relevant case data on one summary report.
Competitive
Strengths
Turnaround
Times
At
NeoGenomics, we strive to provide industry leading turnaround times to our
clients nationwide and to provide information so that physicians can provide
their patients with the correct treatment as soon as possible.
We
believe our average 4-5 day turn-around time for our cytogenetics
testing services and our average 3-4 day turn-around time for FISH testing
services continue to be industry-leading benchmarks for national
laboratories. The consistent timeliness of results is a competitive
strength in cytogenetics and FISH testing and a driver of additional testing
requests by our referring physicians. Quick turn-around times for
cytogenetics and FISH tests allow for the performance of other tests to augment
or confirm results and improve patient care. Without rapid turnaround
times, there is an increased chance that the test results will not be returned
within an acceptable diagnostic window when other adjunctive diagnostic test
results are required. We believe our turn-around times result in our
referring physicians requesting more of our testing services and give us a
significant competitive advantage in marketing our services against those of
other competing laboratories.
National
Direct Sales Force
NeoGenomics
has assembled a strong direct sales force. Our sales representatives
(“Territory Business Managers”) are organized into four regions (Northeast,
Southeast, Central and West). These sales representatives are trained
extensively in cancer genetic testing and consultative selling
skills. As of April 27, 2010, we had 23 Territory Business Managers
and four Regional Managers.
Strategic
Supply Agreement with Abbott Molecular
In July
2009, we entered into a Strategic Supply Agreement with Abbott Molecular, Inc, a
wholly-owned subsidiary of Abbott Laboratories. Under the terms of
this agreement, NeoGenomics has the rights to develop and exclusively launch
three laboratory developed tests (LDTs) based on intellectual property developed
and/or licensed by Abbott. We launched the first of these tests in
February 2010, a FISH test for the diagnosis of melanoma, and expect to launch
the second test in early 2011 and the third in 2012. In conjunction
with the Strategic Supply Agreement, Abbott Laboratories purchased a 9.6% stake
in NeoGenomics.
New
FISH Test for Melanoma
In
February 2010 we launched the first of the three tests developed pursuant to the
Strategic Supply Agreement with Abbott under the trade name
MelanoSITE™. MelanoSITE™ is a four probe FISH test that can be
used as a diagnostic aid to traditional histopathologic evaluation in diagnosing
melanoma. In conjunction with histopathology, the MelanoSITE™
test can help improve classification of melanocytic neoplasms with conflicting
morphologic criteria and help insure proper follow-up. Differential
diagnosis of moderate to severely atypical nevi versus true melanoma is one of
the most challenging areas in dermatopathology. While most melanomas
can be readily distinguished from nevi on histopathologic examination, we
estimate there are about 5% of cases that are ambiguous and show conflicting
morphologic criteria. Diagnostic ambiguity has significant adverse
consequences for patients and the healthcare system at large. Failure
to recognize melanoma is potentially fatal, but labeling a benign lesion as
malignant can lead to unwarranted wide re-excisions, sentinel lymph node
biopsies, adjuvant toxic therapeutic interventions and the emotional strain of
facing a diagnosis of cancer. Considering the large number of
biopsies done in the U.S. to either confirm or rule out melanoma, diagnostic
uncertainty of this scale represents a significant challenge to the U.S.
healthcare system. We believe the MelanoSITE™ test will help address
this diagnostic uncertainty and help to reduce the medical costs associated with
melanoma by providing a more accurate diagnosis.
The
performance characteristics of the MelanoSITE™ test were established in a
multicenter validation study involving over 500 cases, which resulted in a
sensitivity (a measure of true positives and false negatives) of 77% and a
specificity (a measure of true negatives and false positives) of
97%. Importantly, based on our study, the MelanoSITE™ test has a
negative predictive value (NPV) of over 98%. This means that
dermatopathologists and dermatologists can be confident that a patient with a
negative test result has a very low likelihood of having
melanoma. Therefore, the clinician may not need to perform a wide
re-excision of the lesion, potentially scarring a patient for life, and may not
need to perform a sentinel lymph node biopsy which can potentially lead to
further complications such as lymphedema. We expect the marketing and
selling of the MelanoSITE™ test to be a major focus of the Company during
2010.
Client
Care
NeoGenomics
Customer Care Specialists (“CCS”) are organized by region into territories that
service not only our external clients, but also work very closely with and
support our sales team. A client receives personalized assistance
when dealing with their dedicated CCS because each CCS understands their
clients’ specific needs. CCS’s handle everything from arranging
specimen pickup to delivering the results to fulfill NeoGenomics’ objective of
delivering exceptional services to our clients.
Geographic
Locations
In 2009,
we continued an aggressive campaign to regionalize our laboratory operations
around the country to be closer to our clients. Many high complexity
laboratories within the cancer testing niche have frequently operated a core
facility on one or both coasts to service the needs of their customers around
the country. We believe that our clients and prospects desire to do
business with a laboratory with national breadth and a local
presence. NeoGenomics’ has four facilities. The Chatsworth
California location is a small office laboratory for our pathologists. and we
have three main laboratory locations in Fort Myers, Florida; Irvine California;
and Nashville Tennessee and all facilities have the appropriate state licenses
and Clinical Laboratory Improvement Act, as amended (“CLIA”), and College of
American Pathologists (“CAP”) accreditations and are currently receiving
specimens. As situations dictate and opportunities arise, we will
continue to develop and open new laboratories, linked together by our optimized
Laboratory Information System (“LIS”), to better meet the regionalized needs of
our clients.
Laboratory
Information System
NeoGenomics
has what we believe is a state of the art LIS that interconnects our locations
and provides flexible reporting options to clients. This system
allows us to deliver uniform test results throughout our network, regardless of
where the lab that performs any specific test is located. This allows
us to move specimens between locations to better balance our
workload. Our LIS also allows us to offer highly specialized services
to certain sub-segments of our client base. For instance, our
tech-only NeoFISHTM and
NeoFLOWTM
applications allow our community-based pathologist clients to tailor individual
reports to their own customizable report templates. This feature has
been well-received by our tech-only clients.
Scientific
Pipeline
The field
of cancer genetics is rapidly evolving, and we are committed to developing and
offering new tests to meet the needs of the market place based on the latest
scientific discoveries. During 2009, in addition to the validation
work performed for our exclusive Melanoma FISH test, the Company made
significant strides in developing the capability to perform molecular diagnostic
testing in-house. We believe that by adding additional types of tests
to our product offering, we will be able to increase our testing volumes through
our existing client base as well as more easily attract new clients via the
ability to package our testing services more appropriately to the needs of the
market. We expect to launch at least five new molecular tests in
2010.
Critical Accounting
Policies
The
preparation of financial statements in conformity with United States generally
accepted accounting principles requires our management to make estimates and
assumptions that affect the reported amount of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates. Our
management routinely makes judgments and estimates about the effects of matters
that are inherently uncertain. For a complete description of our
significant accounting policies, see Note B to our Consolidated Financial
Statements for the years ended December 31, 2009 and 2008 included
herein.
Our
critical accounting policies are those where we have made difficult, subjective
or complex judgments in making estimates, and/or where these estimates can
significantly impact our financial results under different assumptions and
conditions. Our critical accounting policies are:
|
·
|
Stock
Based Compensation
|
Revenue
Recognition
The
Company recognizes revenues in accordance with SEC Staff Accounting Bulletin
Topic 13.A.1 (ASC 605-10-S99-1), “Revenue Recognition”, when (a) the price is
fixed or determinable, (b) persuasive evidence of an arrangement exists, (c) the
service is performed and (d) collectability of the resulting receivable is
reasonably assured.
The
Company’s specialized diagnostic services are performed based on a written test
requisition form and revenues are recognized once the diagnostic services have
been performed, the results have been delivered to the ordering physician, the
payor has been identified and eligibility and insurance have been
verified. These diagnostic services are billed to various payors,
including Medicare, commercial insurance companies, other directly billed
healthcare institutions such as hospitals and clinics, and
individuals. The Company reports revenues from contracted payors,
including Medicare, certain insurance companies and certain healthcare
institutions, based on the contractual rate, or in the case of Medicare,
published fee schedules. The Company reports revenues from
non-contracted payors, including certain insurance companies and individuals,
based on the amount expected to be collected. The difference between
the amount billed and the amount expected to be collected from non-contracted
payors is recorded as a contractual allowance to arrive at the reported
revenues. The expected revenues from non-contracted payors are based
on the historical collection experience of each payor or payor group, as
appropriate. In each reporting period, the Company reviews its
historical collection experience for non-contracted payors and adjusts its
expected revenues for current and subsequent periods accordingly. As
a result of the economic climate in the United States, we have used shorter and
more current time horizons in analyzing historical experience.
Trade Accounts Receivable
and Allowance For Doubtful Accounts
We record
accounts receivable net of estimated discounts, contractual allowances and
allowances for bad debts. We provide for accounts receivable that
could become uncollectible in the future by establishing an allowance to reduce
the carrying value of such receivables to their estimated net realizable
value. We estimate this allowance based on the aging of our accounts
receivable and our historical collection experience for each type of
payer. Receivables are charged off to the allowance account at the
time they are deemed uncollectible. In the event that the actual
amount of payment received differs from the previously recorded estimate of an
account receivable, an adjustment to revenue is made in the current period at
the time of final collection and settlement. During 2009, we recorded
approximately $279,000 of net total incremental revenue from tests in which we
underestimated the revenue in 2008 relative to the amounts that we ultimately
received in 2009. This was approximately 0.9% of our total 2009
fiscal year revenue and 1.4% of our 2008 fiscal year revenue. During
2008, we recorded approximately $259,000 of net total incremental revenue from
tests in which we underestimated the revenue in 2007 relative to the amounts
that we ultimately received in 2008. This was approximately 1.3% of
our total 2008 fiscal year revenue and 2.3% of our 2007 fiscal year revenue.
These adjustments are not material to the Company’s results of operations in any
period presented. Our estimates of net revenue are subject to change
based on the contractual status and payment policies of the third party payers
with whom we deal. We regularly refine our estimates in order to make
our estimated revenue as accurate as possible based on our most recent
collection experience with each third party payer.
The
following tables present the dollars and percentage of the Company’s net
accounts receivable from customers outstanding by aging category at December 31,
2009 and 2008. All of our receivables were pending approval by
third-party payers as of the date that the receivables were
recorded:
NEOGENOMICS
AGING OF RECEIVABLES BY PAYOR GROUP
December
31, 2009
Payor
Group
|
|
0-30
|
|
|
%
|
|
|
30-60
|
|
|
%
|
|
|
60-90
|
|
|
%
|
|
|
90-120
|
|
|
%
|
|
|
120-150
|
|
|
%
|
|
|
>150
|
|
|
%
|
|
|
Total
|
|
|
%
|
|
Client
|
|
$ |
210,672 |
|
|
|
4 |
% |
|
$ |
425,731 |
|
|
|
8 |
% |
|
$ |
437,552 |
|
|
|
8 |
% |
|
$ |
216,692 |
|
|
|
4 |
% |
|
$ |
52,257 |
|
|
|
1 |
% |
|
$ |
75,884 |
|
|
|
1 |
% |
|
$ |
1,418,788 |
|
|
|
27 |
% |
Commercial
Insurance
|
|
|
581,824 |
|
|
|
11 |
% |
|
|
428,340 |
|
|
|
8 |
% |
|
|
255,488 |
|
|
|
5 |
% |
|
|
152,239 |
|
|
|
3 |
% |
|
|
96,916 |
|
|
|
2 |
% |
|
|
370,977 |
|
|
|
7 |
% |
|
|
1,885,784 |
|
|
|
36 |
% |
Medicaid
|
|
|
18,227 |
|
|
|
0 |
% |
|
|
13,312 |
|
|
|
0 |
% |
|
|
13,552 |
|
|
|
1 |
% |
|
|
11,423 |
|
|
|
0 |
% |
|
|
5,544 |
|
|
|
0 |
% |
|
|
26,049 |
|
|
|
0 |
% |
|
|
88,107 |
|
|
|
2 |
% |
Medicare
|
|
|
895,518 |
|
|
|
17 |
% |
|
|
107,357 |
|
|
|
2 |
% |
|
|
103,804 |
|
|
|
2 |
% |
|
|
41,780 |
|
|
|
1 |
% |
|
|
36,293 |
|
|
|
1 |
% |
|
|
256,861 |
|
|
|
5 |
% |
|
|
1,441,613 |
|
|
|
28 |
% |
Private
Pay
|
|
|
78,842 |
|
|
|
2 |
% |
|
|
71,059 |
|
|
|
1 |
% |
|
|
39,912 |
|
|
|
1 |
% |
|
|
12,866 |
|
|
|
0 |
% |
|
|
20,809 |
|
|
|
0 |
% |
|
|
36,866 |
|
|
|
1 |
% |
|
|
260,374 |
|
|
|
5 |
% |
Unbilled
Revenue
|
|
|
126,564 |
|
|
|
2 |
% |
|
|
- |
|
|
|
0 |
% |
|
|
- |
|
|
|
0 |
% |
|
|
- |
|
|
|
0 |
% |
|
|
- |
|
|
|
0 |
% |
|
|
|
|
|
|
0 |
% |
|
|
126,564 |
|
|
|
2 |
% |
Total
|
|
$ |
1,911,647 |
|
|
|
36 |
% |
|
$ |
1,045,799 |
|
|
|
19 |
% |
|
$ |
850,308 |
|
|
|
17 |
% |
|
$ |
435,000 |
|
|
|
8 |
% |
|
$ |
211,819 |
|
|
|
4 |
% |
|
$ |
766,637 |
|
|
|
14 |
% |
|
$ |
5,221,230 |
|
|
|
100 |
% |
December
31, 2008
Payor
Group
|
|
0-30
|
|
|
%
|
|
|
30-60
|
|
|
%
|
|
|
60-90
|
|
|
%
|
|
|
90-120
|
|
|
%
|
|
|
120-150
|
|
|
%
|
|
|
>150
|
|
|
%
|
|
|
Total
|
|
|
%
|
|
Client
|
|
$ |
280,002 |
|
|
|
9 |
% |
|
$ |
189,811 |
|
|
|
6 |
% |
|
$ |
285,126 |
|
|
|
9 |
% |
|
$ |
176,406 |
|
|
|
5 |
% |
|
$ |
144,897 |
|
|
|
4 |
% |
|
$ |
26,762 |
|
|
|
1 |
% |
|
$ |
1,103,004 |
|
|
|
34 |
% |
Commercial
Insurance
|
|
|
350,009 |
|
|
|
11 |
% |
|
|
217,741 |
|
|
|
7 |
% |
|
|
137,210 |
|
|
|
4 |
% |
|
|
104,836 |
|
|
|
3 |
% |
|
|
70,959 |
|
|
|
2 |
% |
|
|
287,272 |
|
|
|
9 |
% |
|
|
1,168,027 |
|
|
|
36 |
% |
Medicaid
|
|
|
434 |
|
|
|
0 |
% |
|
|
7,312 |
|
|
|
0 |
% |
|
|
14,861 |
|
|
|
1 |
% |
|
|
12,124 |
|
|
|
0 |
% |
|
|
8,078 |
|
|
|
0 |
% |
|
|
42,145 |
|
|
|
1 |
% |
|
|
84,954 |
|
|
|
2 |
% |
Medicare
|
|
|
530,833 |
|
|
|
16 |
% |
|
|
56,334 |
|
|
|
2 |
% |
|
|
33,149 |
|
|
|
1 |
% |
|
|
12,054 |
|
|
|
0 |
% |
|
|
23,378 |
|
|
|
1 |
% |
|
|
53,993 |
|
|
|
2 |
% |
|
|
709,741 |
|
|
|
22 |
% |
Private
Pay
|
|
|
25,341 |
|
|
|
1 |
% |
|
|
35,004 |
|
|
|
1 |
% |
|
|
29,354 |
|
|
|
1 |
% |
|
|
15,969 |
|
|
|
0 |
% |
|
|
13,114 |
|
|
|
0 |
% |
|
|
27,142 |
|
|
|
1 |
% |
|
|
145,924 |
|
|
|
4 |
% |
Unbilled
Revenue
|
|
|
60,523 |
|
|
|
2 |
% |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
60,523 |
|
|
|
2 |
% |
Total
|
|
$ |
1,247,142 |
|
|
|
39 |
% |
|
$ |
506,202 |
|
|
|
16 |
% |
|
$ |
499,700 |
|
|
|
16 |
% |
|
$ |
321,389 |
|
|
|
8 |
% |
|
$ |
260,426 |
|
|
|
7 |
% |
|
$ |
437,314 |
|
|
|
14 |
% |
|
$ |
3,272,173 |
|
|
|
100 |
% |
During
2009, we decreased our accounts receivable greater than 120 days as a percentage
of total accounts receivable by 3%. This decrease could have been
larger but an increase in Medicare receivables greater than 150 days resulted
because of delays in receiving our Medicare provider number for our Chatsworth
facility from California Medicare. The licensing and inspections of this
facility were completed and valid but significant delays in the processing of
our application by California Medicare caused the application to become stale
resulting in us having to resubmit the application several times. In
January 2010 we received our provider number and we expect to be able to
resubmit all previous claims and receive payment on them during the year ending
December 31, 2010.
Based on
a detailed analysis, we believe that our $589,000 allowance for doubtful
accounts, which represents approximately 11% of our receivables balance, is
adequate as of December 31, 2009. At December 31, 2008, our allowance
for doubtful accounts was $359,000 or 11% of accounts
receivable.
Stock Based
Compensation.
The
Company accounts for stock-based compensation in accordance with FASB ASC Topic
718 Compensation – Stock Compensation. ASC Topic
718 requires recognizing compensation costs for all share-based
payment awards made to employees and directors based upon the awards’ grant-date
fair value.
For stock
options, the Company uses a trinomial lattice option-pricing model to estimate
the grant-date fair value of stock option awards, and recognizes compensation
cost on a straight-line basis over the awards’ requisite service
periods. The Company estimates an expected forfeiture rate, which is
factored into the determination of the Company’s quarterly expense.
See Note
B – Summary of Significant Accounting Policies - Stock-Based Compensation and
Note F – Stock Based Compensation in the Notes to Consolidated Financial
Statements for more information regarding the valuation of stock-based
compensation.
Results
of Operations for the Three Months Ended March 31, 2010 as
Compared to the Three Months Ended March 31, 2009
The
following table presents the condensed consolidated statements of operations as
a percentage of revenue:
|
|
For
the three months ended
March 31.
|
|
|
|
2010
|
|
|
2009
|
|
NET
REVENUE
|
|
|
100 |
% |
|
|
100 |
% |
COST
OF REVENUE
|
|
|
52 |
% |
|
|
45 |
% |
GROSS
PROFIT
|
|
|
48 |
% |
|
|
55 |
% |
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
34 |
% |
|
|
34 |
% |
Sales
and marketing
|
|
|
21 |
% |
|
|
19 |
% |
TOTAL
OPERATING EXPENSES
|
|
|
55 |
% |
|
|
53 |
% |
|
|
|
|
|
|
|
|
|
Interest
(income) expense, net
|
|
|
2 |
% |
|
|
2 |
% |
NET
INCOME (LOSS)
|
|
|
(9 |
)% |
|
|
0 |
% |
Revenue
The
Company’s specialized testing services are performed based on a written test
requisition form and revenues are recognized once the testing services have been
performed, the results have been delivered to the ordering physician, the payor
has been identified and eligibility and insurance have been verified. Our
testing services are billed to various payors, including Medicare, commercial
insurance companies, other directly billed healthcare institutions such as
hospitals and clinics, and individuals. We report revenues from contracted
payors, including Medicare, certain insurance companies and certain healthcare
institutions, based on the contractual rate, or in the case of Medicare,
published fee schedules. We report revenues from non-contracted payors,
including certain insurance companies and individuals, based on the amount
expected to be collected. The difference between the amount billed and the
amount expected to be collected from non-contracted payors is recorded as a
contractual allowance to arrive at the reported revenues. The expected revenues
from non-contracted payors are based on the historical collection experience of
each payor or payor group, as appropriate. In each reporting period, we review
our historical collection experience for non-contracted payors and adjust our
expected revenues for current and subsequent periods accordingly.
Revenues
increased approximately 22%, or $1.5 million, to $8.4 million for the three
months ended March 31, 2010 as compared to $6.9 million for the three months
ended March 31, 2009. The revenue increase for the three months ended March 31,
2010, as compared to the comparable period in 2009, was primarily driven by
increases in the number of tests performed partially offset by a decline in
average revenue per test.
Test
volume increased approximately 34% for the three months ended March 31, 2010.
Increases in test volumes were primarily driven by the substantial increases in
sales and marketing activities by the Company over the past twelve
months.
Revenues
per test are a function of both the type of the test (e.g. FISH, cytogenetics,
flow cytometry, etc.) and the payer (e.g., Medicare, Medicaid, third party
insurer, institutional client etc.). Average revenue per test is primarily
driven by our test type mix and our payer mix. The decrease in average revenue
per test for the three months ended March 31, 2010 is primarily the result of
decreases in our managed care reimbursements and to a lesser extent from lower
priced tests in our test type mix.
We have
established a reserve for uncollectible amounts based on estimates of what we
will collect from: a) third-party payers with whom we do not have a contractual
arrangement or sufficient experience to accurately estimate the amount of
reimbursement we will receive, b) payments directly from patients, and c) those
procedures that are not covered by insurance or other third party payers. The
Company’s allowance for doubtful accounts increased 18%, or approximately
$106,000 to $695,000, as compared to $589,000 at December 31, 2009. The
allowance for doubtful accounts was approximately 11% of accounts receivable on
March 31, 2010 and December 31, 2009.
Cost of
Revenue
Cost of
revenue includes payroll and payroll related costs for performing tests,
depreciation of laboratory equipment, rent for laboratory facilities, laboratory
reagents, probes and supplies, and delivery and courier costs relating to the
transportation of specimens to be tested.
Cost of
revenue increased approximately 41%, or $1.2 million, to $4.3 million for the
three months ended March 31, 2010 as compared to $3.1 million for the three
months ended March 31, 2009. The increase was primarily attributable to
increases in all areas of costs of revenue as the Company scaled its operations
in order to meet increasing demand. Cost of revenue as a percentage of revenue
was approximately 52% for the three months ended March 31, 2010 as compared to
45% for the three months ended March 31, 2009.
Accordingly,
gross margin was approximately 48% for the three months ended March 31, 2010 as
compared to 55% for the three months ended March 31, 2009. This decline in gross
margin is primarily the result of our largest customer at March 31, 2009
bringing in-house certain high margin tests in the second quarter of 2009 and
replacing a portion of that volume with additional low margin testing. This
customer represented 6% of total revenue for the three months ended March 31,
2010 compared to 18% for the comparable period in 2009.
Sales and
Marketing
Sales and
marketing expenses relate primarily to the employee related costs of our sales
management, sales representatives, marketing, and customer service
personnel.
|
|
For
the three months ended
March 31,
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
%
Change
|
|
Sales
and marketing
|
|
$ |
1,763,000 |
|
|
$ |
1,334,000 |
|
|
|
32 |
% |
As
a % of revenue
|
|
|
21 |
% |
|
|
19 |
% |
|
|
|
|
The
increase in sales and marketing expenses is primarily a result of adding
substantial numbers of sales and marketing personnel in 2009 to generate
additional revenue growth as well as marketing costs related to our Melanoma
FISH test.
We expect
our sales and marketing expenses to increase as we hire additional sales
management, sales representatives, and marketing personnel as part of our growth
strategy. However, we expect these expenses to decline as a percentage of
revenue as our case volumes increase and we develop more economies of scale in
our sales and marketing activities.
General and Administrative
Expenses
General
and administrative expenses relate to billing, bad debts, finance, human
resources, information technology, and other administrative functions. They
primarily consist of employee related costs (such as salaries, fringe benefits,
and stock-based compensation expense), professional services, facilities
expense, and depreciation and administrative-related costs allocated to general
and administrative expenses. In addition, the provision for doubtful accounts is
included in general and administrative expenses.
|
|
For
the three months ended
March 31,
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
%
Change
|
|
General
and administrative
|
|
$ |
2,902,000 |
|
|
$ |
2,341,000 |
|
|
|
24 |
% |
As
a % of revenue
|
|
|
34 |
% |
|
|
34 |
% |
|
|
|
|
The
increase in general and administrative expenses is primarily a result of adding
additional management and information technology personnel and due to
approximately $200,000 of additional R&D expenses incurred to develop the
Melanoma FISH test.
Bad debt
expense increased by approximately 7%, or $33,000, to $540,000 for the three
months ended March 31, 2010 as compared to $508,000 for the three months ended
March 31, 2009. Bad debt expense as a percentage of revenue for the three months
ended March 31, 2010 was 6.5% as compared to 7.3% for the three months ended
March 31, 2009.
The
decrease in bad debt expense as a percentage of revenue is the result of
improvements in our billing practices.
We expect
our general and administrative expenses to increase as we add personnel;
increase our billing and collections activities; incur additional expenses
associated with the expansion of our facilities and backup systems; and continue
to build our physical infrastructure to support our anticipated growth. However,
we expect general and administrative expenses to decline as a percentage of our
revenue as our case volumes increase and we develop more operating leverage in
our business.
Interest Expense,
net
Interest
expense net, which represents the interest expense we incur on our borrowing
arrangements offset by the interest income we earn on cash deposits. Interest
expense, net increased approximately 39%, or $44,000 to $159,000 for the three
months ended March 31, 2010 as compared to $115,000 for the three months ended
March 31, 2009. Interest expense is primarily related to the amount of our
capital leases outstanding and to a lesser extent to the borrowing under our
credit facility with CapitalSource Finance, LLC (“CapitalSource”). Interest
expense increased over the same period in the prior year primarily as a result
of the higher capital lease and working capital facility balances as of March
31, 2010 as compared to March 31, 2009.
Net Income
(Loss)
As a
result of the foregoing, we reported a net loss of $750,000, or $(0.02)/share,
for the three months ended March 31, 2010 as compared to a net income of
$33,000, or $0.00/share, for the three months ended March 31, 2009.
Results of Operations for
the year ended December 31, 2009 as compared with the year ended December 31,
2008
The
following table presents the condensed consolidated statements of operations as
a percentage of revenue:
|
|
For
the year ended
December 31.
|
|
|
|
2009
|
|
|
2008
|
|
NET
REVENUE
|
|
|
100 |
% |
|
|
100 |
% |
COST
OF REVENUE
|
|
|
48 |
% |
|
|
47 |
% |
GROSS
PROFIT
|
|
|
52 |
% |
|
|
53 |
% |
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
34 |
% |
|
|
41 |
% |
Sales
and marketing
|
|
|
24 |
% |
|
|
17 |
% |
TOTAL
OPERATING EXPENSES
|
|
|
58 |
% |
|
|
58 |
% |
|
|
|
|
|
|
|
|
|
Interest
(income) expense, net
|
|
|
2 |
% |
|
|
2 |
% |
NET
INCOME (LOSS)
|
|
|
(8 |
)% |
|
|
(7 |
)% |
Revenue
The
Company’s specialized testing services are performed based on a written test
requisition form and revenues are recognized once the testing services have been
performed, the results have been delivered to the ordering physician, the payor
has been identified and eligibility and insurance have been verified. Our
testing services are billed to various payors, including Medicare, commercial
insurance companies, other directly billed healthcare institutions such as
hospitals and clinics, and individuals. We report revenues from contracted
payors, including Medicare, certain insurance companies and certain healthcare
institutions, based on the contractual rate, or in the case of Medicare,
published fee schedules. We report revenues from non-contracted payors,
including certain insurance companies and individuals, based on the amount
expected to be collected. The difference between the amount billed and the
amount expected to be collected from non-contracted payors is recorded as a
contractual allowance to arrive at the reported revenues. The expected revenues
from non-contracted payors are based on the historical collection experience of
each payor or payor group, as appropriate. In each reporting period, we review
our historical collection experience for non-contracted payors and adjust our
expected revenues for current and subsequent periods accordingly.
During
the year ended December 31, 2009, our revenues increased approximately 47% to
$29,469,000 from $20,015,000 during the year ended December 31, 2008.
..
Test
volume increased approximately 40% for the year ended December 31, 2009.
Increases in test volumes were primarily driven by the substantial increases in
sales and marketing activities by the Company over the past year.
For the
year ended December 31, 2009, our average revenue per client requisition
increased by approximately 15% to $931 from $808 in 2008. Our average
revenue per test increased by approximately 5% to $645 in 2009 from $615 in
2008. Revenues per test are a function of both the type of the test
and the payer.
Cost of
Revenue
Cost of
revenue includes payroll and payroll related costs for performing tests,
depreciation of laboratory equipment, rent for laboratory facilities, laboratory
reagents, probes and supplies, and delivery and courier costs relating to the
transportation of specimens to be tested.
Our cost
of revenue, as a percentage of gross revenue, increased from 47% for the year
ended December 31, 2008 to 48% for the year ended December 31,
2009. This increase was primarily the result of the restructuring of
our relationship with our largest customer and the resulting change in mix from
a higher margin test to a lower margin test.
Gross
Profit
As
a result of the 47% increase in revenue and our 48% cost of revenue, our gross
profit increased 43% to $15,215,000 for the year ended December 31, 2009, from a
gross profit of $10,661,000 for the year ended December 31, 2008. When expressed
as a percentage of revenue, our gross margins decreased from 53.3% for the year
ended December 31, 2008 to 51.6% for the year ended December 31,
2009.
Sales and
Marketing
Sales and
marketing expenses relate primarily to the employee related costs of our sales
management, sales representatives, marketing, and customer service
personnel.
|
|
For
the year ended
December 31.
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
%
Change
|
|
Sales
and marketing
|
|
$ |
6,885,000 |
|
|
$ |
3,367,000 |
|
|
|
105 |
% |
As
a % of revenue
|
|
|
23 |
% |
|
|
17 |
% |
|
|
|
|
Sales and
marketing expenses increased approximately 105%, or $3,519,000 to $6,885,000 for
the year ended December 31, 2009 as compared to $3,367,000 for the year ended
December 31, 2008, primarily as a result of adding substantial numbers of sales
and marketing personnel in 2009 to generate additional revenue
growth. At December 31, 2009, we had 43 sales and marketing and
customer care personnel compared with 33 sales and marketing and customer care
personnel at December 31, 2008.
We expect
our sales and marketing expenses to increase as we hire additional sales
management, sales representatives, and marketing personnel as part of our growth
strategy. However, we expect these expenses to decline as a percentage of
revenue as our case volumes increase and we develop more economies of scale in
our sales and marketing activities.
General and Administrative
Expenses
General
and administrative expenses relate to billing, finance, human resources,
information technology, and other administrative functions. They primarily
consist of employee related costs (such as salaries, fringe benefits, and
stock-based compensation expense), professional services, facilities expense,
and depreciation and administrative-related costs allocated to general and
administrative expenses. In addition, the provision for doubtful accounts is
included in general and administrative expenses.
|
|
For
the year ended
December 31.
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
%
Change
|
|
General
and administrative
|
|
$ |
10,057,000 |
|
|
$ |
8,179,000 |
|
|
|
23 |
% |
As
a % of revenue
|
|
|
34 |
% |
|
|
41 |
% |
|
|
|
|
General
and administrative expenses increased approximately 23%, or $1,878,000 to
$10,057,000 for the year ended December 31, 2009 as compared to $8,179,000 for
the year ended December 31, 2008. The increase in general and administrative
expenses is primarily a result of adding additional management, information
technology, and billing personnel to support the increase in our
revenue.
Bad debt
expense increased by approximately 20%, or $365,000 to $2,155,000 for the year
ended December 31, 2009 as compared to $1,790,000 for the year ended December
31, 2008. This increase was primarily a result of the significant increases in
revenue partially offset by a decrease in bad debt as percentage of revenue. Bad
debt as a percentage of revenue decreased 1.6% to 7.3% for the year ended
December 31, 2009 from 8.9% of revenue for the year ended December 31,
2008. This decline was the result of managed care contracts we
entered into during the year and improved performance by our billing
department.
We expect
our general and administrative expenses to increase as we add personnel,
increase our billing and collections activities; incur additional expenses
associated with the expansion of our facilities and backup systems; and continue
to build our physical infrastructure to support our anticipated growth. However,
we expect general and administrative expenses to continue to decline as a
percentage of our revenue as our case volumes increase and as we continue to
develop more operating leverage in our business.
Other (Income)
Expense
Other
income and expense primarily represents the interest expense we incur on our
borrowing arrangements (primarily comprised of interest payable on advances
under our revolving credit facility with Capital Source and interest paid on
capital lease obligations) offset by the interest income we earn on cash
deposits. Interest expense increased from $309,000 in 2008 to
$532,000 in 2009, reflecting higher borrowings, particularly related to our
capital lease obligations as we acquired additional equipment to support our
increasing volume of business. This increase was largely offset in 2009 because
in 2008 we incurred a one-time $200,000 write down of our investment associated
with a potential joint venture, as discussed in Note M to our consolidated
financial statements.
Net Loss
As
a result of the foregoing, our net loss increased approximately 62% from
approximately ($1,383,000) or $(0.04) per share for the year ended December 31,
2008 to approximately ($2,243,000) or $(0.06) per share for the year ended
December 31, 2009.
Commitments
Employment Contracts with
named Executive Officers
The
Company is a party to employment contracts with several of its officer’s that
contain commitments as described in Note G to our consolidated financial
statements and detailed below is a list of all such contracts signed during
2009.
On March
16, 2009, the Company entered into an employment agreement with Douglas M.
VanOort (the “Employment Agreement”) to
employ Mr. VanOort in the capacity of Executive Chairman and interim Chief
Executive Officer. The Employment Agreement has an initial term from
March 16, 2009 through March 16, 2013, which initial term automatically renews
for one year periods. Mr. VanOort will receive a salary of $225,000
per year for so long as he spends not less than 2.5 days per week on the affairs
of the Company. He will receive an additional $50,000 per year while
serving as the Company’s interim Chief Executive Officer; provided that he
spends not less than 3.5 days per week on average on the affairs of the
Company. Mr. VanOort is also eligible to receive an annual cash bonus
based on the achievement of certain performance metrics of at least 30% of his
base salary (which includes amounts payable with respect to serving as Executive
Chairman and interim Chief Executive Officer). Mr. VanOort is also
entitled to participate in all of the Company’s employee benefit plans and any
other benefit programs established for officers of the Company.
The
Employment Agreement also provides that Mr. VanOort will be granted an option to
purchase 1,000,000 shares of the Company’s common stock under the Company’s
Amended and Restated Equity Incentive Plan (the “Amended Plan”). The
exercise price of such option is $0.80 per share. 500,000 shares of
common stock subject to the option will vest according to the following schedule
(i) 200,000 shares will vest on March 16, 2010 (provided that if Mr. VanOort’s
employment is terminated by the Company without “cause” then the pro rata
portion of such 200,000 shares up until the date of termination shall vest);
(ii) 12,500 shares will vest each month beginning on April 16, 2010 until March
16, 2011; (iii) 8,000 shares will vest each month beginning on April 16, 2011
until March 16, 2012 and (iv) 4,500 shares will vest each month beginning on
April 16, 2012 until March 16, 2013. 500,000 shares of common stock
subject to the option will vest based on the achievement of certain performance
metrics by the Company. Any unvested portion of the option described
above shall vest in the event of a change of control of the
Company.
Either
party may terminate Mr. VanOort’s employment with the Company at any time upon
giving sixty days advance written notice to the other party. The
Company and Mr. VanOort also entered into a Confidentiality, Non-Solicitation
and Non-Compete Agreement in connection with the Employment
Agreement.
On March
16, 2009, the Company and the Douglas M. VanOort Living Trust entered into a
Subscription Agreement (the “Subscription Agreement”) pursuant to which the
Douglas M. VanOort Living Trust purchased 625,000 shares of the Company’s common
stock at a purchase price of $0.80 per share (the “Subscription
Shares”). The Subscription Shares are subject to a two year lock-up
that restricts the transfer of the Subscription Shares; provided, however, that
such lock-up shall expire in the event that the Company terminates Mr. VanOort’s
employment. The Subscription Agreement also provides for certain
piggyback registration rights with respect to the Subscription
Shares.
On March
16, 2009, the Company and Mr. VanOort entered into a Warrant Agreement (the
“Warrant Agreement”) pursuant to which Mr. VanOort, subject to the vesting
schedule described below, may purchase up to 625,000 shares of the Company’s
common stock at an exercise price of $1.05 per share (the “Warrant
Shares”). The Warrant Shares vest based on the following vesting
schedule:
|
(i)
|
20%
of the Warrant Shares vest
immediately,
|
|
(ii)
|
20%
of the Warrant Shares will be deemed to be vested on the first day on
which the closing price per share of the Company’s common stock has
reached or exceeded $3.00 per share for 20 consecutive trading
days,
|
|
(iii)
|
20%
of the Warrant Shares will be deemed to be vested on the first day on
which the closing price per share of the Company’s common stock has
reached or exceeded $4.00 per share for 20 consecutive trading
days,
|
|
(iv)
|
20%
of the Warrant Shares will be deemed to be vested on the first day on
which the closing price per share of the Company’s common stock has
reached or exceeded $5.00 per share for 20 consecutive trading days
and
|
|
(v)
|
20%
of the Warrant Shares will be deemed to be vested on the first day on
which the closing price per share of the Company’s common stock has
reached or exceeded $6.00 per share for 20 consecutive trading
days.
|
In the
event of a change of control of the Company in which the consideration payable
to each common stockholder of the Company in connection with such change of
control has a deemed value of at least $4.00 per share then the Warrant Shares
shall immediately vest in full. In the event that Mr. VanOort resigns
his employment with the Company or the Company terminates Mr. VanOort’s
employment for “cause” at any time prior to the time when all Warrant Shares
have vested, then the rights under the Warrant Agreement with respect to the
unvested portion of the Warrant Shares as of the date of termination will
immediately terminate.
On
October 28, 2009, the Company appointed Mr. VanOort, to the position of Chief
Executive Officer and amended and restated his employment agreement, as
previously disclosed, pursuant to a Current Report on Form 8-K filed with the
Securities and Exchange Commission on November 3, 2009. Mr. VanOort previously
held the position of Executive Chairman and Interim Chief Executive Officer of
the Company from March 16, 2009 until October 28, 2009. Mr. VanOort also serves
as the Chairman of the Company’s Board of Directors.
On July
22, 2009, the Company entered into an employment agreement with Grant Carlson
(to employ Mr. Carlson in the capacity of Vice President Sales.. The
Offer Letter provides for a four (4) year term, which is terminable upon written
notice by either party. The Offer Letter also provides for an initial
base salary of $200,000 per year and provides that Mr. Carlson is eligible to
receive an incentive bonus targeted at 30% of his base salary based on the
achievement of certain goals. Mr. Carlson is entitled to participate
in all medical and other benefits that the Company has established for its
employees. Mr. Carlson also is entitled to an automobile allowance of
$700 per month (plus reimbursement for work-related gas expenses) and
reimbursement for personal telephone and cell phone use at a rate of $250 per
month. Mr. Carlson is also eligible for four (4) weeks of paid time
off per year. Mr. Carlson is also eligible for up to $20,000 of
relocation assistance. Mr. Carlson was granted 150,000 stock options
at an exercise price of $1.34 and with a five year term so long as Mr. Carlson
remains an employee of the Company. These options are scheduled to
vest according to the passage of time. So long as Mr. Carlson remains
employed by the Company, such option will have a five-year term and will be
subject to time and performance based vesting. If Mr. Carlson resigns
prior to July 6, 2010, he will forfeit the option. If the Company
terminates Mr. Carlson without cause then the Company will continue to pay Mr.
Carlson’s base salary and maintain his employee benefits for a period of six (6)
months.
On
November 30, 2009, we entered into an employment agreement with George Cardoza,
our Chief Financial Officer. The Employment Agreement has an initial
term from November 30, 2009 through November 29, 2013, which initial term
automatically renews for one year periods. The employment agreement
specifies an initial base salary of $190,000/year. Mr. Cardoza is
also entitled beginning with the year ended December 31, 2010 to receive cash
bonuses for any given fiscal year in an amount equal to 30% of his base salary
if he meets certain goals established by the CEO and approved by the board of
directors. In addition, Mr. Cardoza was granted 150,000 stock options at an
exercise price of $1.55 and with a five year term so long as Mr. Cardoza remains
an employee of the Company. These options are scheduled to vest
according to the passage of time. Mr. Cardoza's employment agreement
also specifies that he is entitled to four weeks of paid vacation per year and
other insurance benefits. Mr. Cardoza is also eligible for up to $20,000 of
relocation assistance. In the event that Mr. Cardoza is terminated without cause
by the Company, the Company has agreed to pay Mr. Cardoza's base salary and
maintain his benefits for a period of six months.
On
December 7, 2009, we entered into an employment agreement with Jack G. Spitz,
our Vice President of Laboratory Operations. The Employment Agreement
has an initial term from December 7, 2009 through December 6, 2013, which
initial term automatically renews for one year periods. The
employment agreement specifies an initial base salary of
$210,000/year. Mr. Spitz is also entitled beginning with the year
ended December 31, 2010 to receive cash bonuses for any given fiscal year in an
amount equal to 30% of his base salary if he meets certain goals established by
the President or CEO and approved by the board of directors. In addition, Mr.
Spitz was granted 150,000 stock options at an exercise price of $1.52 and with a
five year term so long as Mr. Spitz remains an employee of the
Company. These options are scheduled to vest according to the passage
of time. Mr. Spitz's employment agreement also specifies that he is
entitled to four weeks of paid vacation per year and other insurance benefits.
Mr. Spitz is also eligible for up to $35,000 of relocation assistance. In the
event that Mr. Spitz is terminated without cause by the Company, the Company has
agreed to pay Mr. Spitz's base salary and maintain his benefits for a period of
six months.
Purchase
Commitments
The
Company had open purchase commitments with two vendors of laboratory equipment
for approximately $500,000 of equipment at December 31, 2009. This
equipment was delivered in January 2010.
Operating
Commitments
The
Company leases its laboratory and office facilities under non-cancelable
operating leases. Please refer to Note G of the consolidated
financial statements for a schedule of commitments for operating
leases.
Capital Lease
Obligations
The
Company leases certain property and equipment under various agreements accounted
for as capital lease obligations. Please refer to Note K of the
consolidated financial statements for a schedule of capital lease
commitments. Two lease lines were established during the fourth
quarter of 2010 as below.
Wells Fargo Lease
Agreement
On
October 2, 2009, we and Wells Fargo Equipment Finance, Inc. (“Wells Fargo”),
entered into a Master Lease Agreement (the “Wells Fargo Lease”). The Wells Fargo
Lease establishes the general terms and conditions pursuant to which NeoGenomics
Laboratories, Inc. may lease $750,000 in equipment. Advances under the lease
line may be made for 180 days by executing supplemental schedules for each
advance, which would have a 60 month term.
On
October 2, 2009, we entered into Lease Supplement No. 1 of the Wells Fargo Lease
for $265,200 which was funded to one vendor for lab equipment. Supplement No. 1
has a term of 60 months with monthly payments of $5,396 and a $1.00 final
purchase payment at termination. Supplement No. 1 is being accounted for as a
capital lease.
At
December 31, 2009 there was $484,800 remaining on this capital lease
line.
SunTrust Lease
Agreement
On
October 28, 2009, we and SunTrust Equipment Finance & Leasing Corp.
(“SunTrust”), entered into an equipment lease agreement (the “SunTrust Lease”).
The SunTrust Lease establishes the general terms and conditions pursuant to
which the Subsidiary may lease up to $1.5 million in equipment and other
property.
On
November 12, 2009, we entered into Lease Schedule No. 1 of the SunTrust lease
for $428,465 which was funded to several vendors for lab equipment, computer
hardware and furniture and fixtures. Schedule 1 has a term of 60 months with
monthly payments of $8,433 and a $1.00 final purchase payment at termination.
Schedule No. 1 is being accounted for as a capital lease. As part of
this schedule, we agreed to keep at least $1,000,000 in compensating cash
balances with SunTrust as long as we owed any monies under the schedule. This
balance is accounted for as current restricted cash as we have the ability to
pay-off the schedule at any time and as a result of that we have shown the
principal owed on the arrangement as a current liability.
At
December 31, 2009 there was $1,071,535 available to borrow on this
facility.
Liquidity and Capital
Resources
The
following table presents a summary of our cash flows provided by (used in)
operating, investing and finance activities for the three months ended March 31,
2010 and 2009 as well as the period ending cash and cash equivalents and working
capital.
|
|
For
the three months ended
March 31.
|
|
|
|
2010
|
|
|
2009
|
|
Net
cash provided by (used in):
|
|
|
|
|
|
|
Operating
activities
|
|
$ |
(1,564,000 |
) |
|
$ |
(331,000 |
) |
Investing
activities
|
|
|
(114,000 |
) |
|
|
(6,000 |
) |
Financing
activities
|
|
|
1,708,000 |
|
|
|
726,000 |
|
Net
increase in cash and cash equivalents
|
|
|
30,000 |
|
|
|
389,000 |
|
Cash
and cash equivalents, beginning of period
|
|
|
1,631,000 |
|
|
|
468,000 |
|
Cash
and cash equivalents, end of period (1)
|
|
$ |
1,661,000 |
|
|
$ |
857,000 |
|
Working
Capital (2), end of period
|
|
$ |
1,766,000 |
|
|
$ |
2,744,000 |
|
(1) This
excludes restricted cash of $1.0M
(2)
Defined as current assets - current liabilities.
The large
increase in cash used in operations for the three months ended March 31, 2010 as
compared to the comparable period in 2009 is primarily the result of loss from
operations, increases in our Accounts Receivable from increased revenues, as
well as the result of legislation that expired on December 31, 2009 which
grandfathered the implementation of new reimbursement procedures for the
technical component of Medicare tests performed for certain hospital clients
(known as the “TC Grandfather” legislation). The extension of this
legislation was part of the Patient Protection and Affordable Care Act, HR 3590
which was delayed and not signed by the President until late March
2010. As a result of this the Centers for Medicare and Medicaid
Services (“CMS”), had asked reference laboratories to hold off on submission of
the grandfather related claims and therefore we did not submit claims for
approximately $750,000 until the last week of March 2010. We expect
to be paid on these claims in the second quarter of 2010 and have seen
significant cash collections in April related to these claims.
The
increase in cash used in investing activities relates to paying more cash for
capital expenditures than in the prior year.
The
increase in net cash flow provided by financing activities was primarily the
result of increases in funding on our Capital Source working capital facility
related to the increase in Accounts Receivable as well as our operating
losses. This funding was partially offset by payments on our capital
lease facilities.
The
following table presents a summary of our cash flows provided by (used in)
operating, investing and financing activities for the year ended December 31,
2009 and 2008 as well as the period ending cash and cash equivalents and working
capital.
|
|
For
the year ended
December 31.
|
|
|
|
2009
|
|
|
2008
|
|
Net
cash provided by (used in):
|
|
|
|
|
|
|
Operating
activities
|
|
$ |
(1,500,417 |
) |
|
$ |
(138,306 |
) |
Investing
activities
|
|
|
(963,740 |
) |
|
|
(501,781 |
) |
Financing
activities
|
|
|
3,627,055 |
|
|
|
897,685 |
|
Net
increase in cash and cash equivalents
|
|
|
1,162,898 |
|
|
|
257,598 |
|
Cash
and cash equivalents, beginning of period
|
|
|
468,171 |
|
|
|
210,573 |
|
Cash
and cash equivalents, end of period
|
|
$ |
1,631,069 |
|
|
$ |
468,171 |
|
Working
Capital (1), end of period
|
|
$ |
2,743,903 |
|
|
$ |
(35,425 |
) |
|
(1)
|
Defined
as current assets less current
liabilities.
|
During
the year ended December 31, 2009, our operating activities used approximately
$1,500,000 of cash compared with $138,000 of cash used in the comparable period
in 2008. This increase was primarily as a result of the increase in
accounts receivable in 2009 as compared with 2008. Cash used in investing
activities was approximately $964,000 in 2009 compared with $502,000 in 2008,
reflecting increased purchases of equipment to support our increased volume of
business. In 2009, our net cash flow provided by financing activities
was approximately $3,627,000 which was primarily derived from sales of our
common stock and the exercise of common stock warrants. At December
31, 2009 and 2008, we had unrestricted cash and cash equivalents of
approximately $1,630,000 and $468,000 respectively. We also had
$1,000,000 of restricted cash at December 31, 2009.
On
November 5, 2008, we entered into a common stock purchase agreement (the “Stock
Agreement”) with Fusion Capital Fund II, LLC an Illinois limited liability
company (“Fusion”). The Stock Agreement, which has a term of 30 months, provides
for the future funding of up to $8.0 million from sales of our common stock to
Fusion on a when and if needed basis as determined by us in our sole discretion,
depending on, among other things, the market price of our common stock. As of
March 31, 2010, we had not drawn on any amounts under the Fusion Stock
Agreement.
On
February 1, 2008, we entered into a revolving credit facility with
CapitalSource, which allows us to borrow up to $3,000,000 based on a formula
which is tied to our eligible accounts receivable that are aged less than 150
days.
As of
March 31, 2010, we had approximately $1,661,000 in cash on hand, $547,000 of
availability under our credit facility, and up to $8.0 million under the Fusion
Stock Agreement. As such, we believe we have adequate resources to meet our
operating commitments for the next twelve months, and accordingly our
consolidated financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or the amounts and
classification of liabilities that might be necessary should we be unable to
continue as a going concern.
On April
26, 2010 as described more fully in subsequent events we increased our Credit
Facility to $5.0 million and we had an outstanding amount due on the Credit
Facility of approximately $2.3 million and the available credit under the Credit
Facility was approximately $1.7 million.
Capital
Expenditures
We
currently forecast capital expenditures in order to execute on our business
plan. The amount and timing of such capital expenditures will be determined by
the volume of business, but we currently anticipate that we will need to
purchase approximately $3.0 million to $4.0 million of additional capital
equipment during the next year. We plan to fund these expenditures
with cash, through bank loan facilities, and through capital lease financing
arrangements. If we are unable to obtain such funding, we will need to pay cash
for these items or we will be required to curtail our equipment purchases, which
may have an impact on our ability to continue to grow our
revenues. Please see Note K to the consolidated financial statements
for further detail with respect to lease financing facilities.
Subsequent
Events
SunTrust Lease
Agreement
On April
13, 2010, the Company entered into Lease Schedule No. 3 of the SunTrust lease
for approximately $249,000 which was funded to several vendors for lab equipment
and computer hardware. Schedule 3 has a term of 60 months with monthly payments
of approximately $4,900 and a $1.00 final purchase payment at termination.
Schedule No. 3 is being accounted for as a capital lease.
After
entering into Lease Schedule No. 3 on January 19, 2010, we have approximately
$533,000 available for further advances under the SunTrust Lease.
Amended and Restated
Revolving Credit and Security Agreement with Capital Source
Bank
On April
26, 2010, the Parent Company, NeoGenomics Laboratories, Inc., the wholly-owned
subsidiary of the Parent Company (“Borrower”), and CapitalSource entered into an
Amended and Restated Revolving Credit and Security Agreement (the “Amended and
Restated Credit Agreement”). The Amended and Restated Credit
Agreement amended and restated the Revolving Credit and Security Agreement dated
February 1, 2008, as amended, among the Parent Company, Borrower and
CapitalSource (the “Original Credit Agreement”). The terms of the
Amended and Restated Credit Agreement and the Original Credit Agreement are
substantially similar except that the Amended and Restated Credit Agreement,
among other things, (i) increases the maximum principal amount of the revolving
credit facility from $3,000,000 to $5,000,000, (ii) provides that the term of
the Amended and Restated Credit Agreement shall end on February 1,
2013, (iii) increases the amount of the collateral management fee and
unused line fees paid by Borrower to CapitalSource, (iv) modifies the
definitions of “Minimum Termination Fee” and “Permitted Indebtedness”, (v)
provides that the Borrower must maintain a minimum outstanding principal balance
under the revolving facility of at least $2,000,000, (vi) increases the interest
rate to LIBOR plus 4.25% (provided that LIBOR shall not be less than 2.0%) and
(vii) revises certain covenants and representations and
warranties. Borrower paid CapitalSource a commitment fee of
$33,500 in connection with the execution of the Amended and Restated Credit
Agreement (CapitalSource credited $25,000 of the amendment fee previously paid
by the Borrower in connection with the March 26, 2010 amendment of the Original
Credit Agreement towards the commitment fee).
Recent Accounting
Pronouncements
The
following accounting pronouncements were adopted by the Company during
2009:
On July
1, 2009, the Company adopted the provisions of ASU 2009-05, Fair Value
Measurements and Disclosures (Topic 820)—Measuring Liabilities at Fair
Value. It had no impact on the Company’s financial condition or
results of operations. Under this standard, companies determining the
fair value of a liability may use the perspective of an investor that holds the
related obligation as an asset. This topic addresses practice difficulties
caused by the tension between fair-value measurements based on the price that
would be paid to transfer a liability to a new obligor and contractual or legal
requirements that prevent such transfers from taking place. No new fair-value
measurements are required by the standard.
In May
2009, the Financial Accounting Standards Board issued Topic 855, Subsequent
Events. This topic addresses accounting and disclosure requirements related to
subsequent events. It requires management to evaluate subsequent events through
the date the financial statements are either issued or available to be issued,
depending on the company’s expectation of whether it will widely distribute its
financial statements to its shareholders and other financial statement users.
Companies are required to disclose the date through which subsequent events have
been evaluated – see Note B to our consolidated financial
statements.
The
Company has determined that all other recently issued accounting standards will
not have a material impact on its consolidated financial statements, or do not
apply to its operations.
Related Party
Transactions
Consulting
Agreements
During
2009 and 2008, Steven C. Jones, a director of the Company, earned $199,600 and
$176,300, respectively, for various consulting work performed in connection with
his duties as Acting Principal Financial Officer.
During
the three months ended March 31, 2010 and 2009, Steven C. Jones, a director of
the Company, earned approximately $67,000 and $56,000, respectively, for various
consulting work performed in connection with his duties as Executive Vice
President of Finance or Acting Principal Financial Officer.
During
2009 and 2008, George O’Leary, a director of the Company, earned $60,200 and
$22,200, respectively, in cash for various consulting work performed for the
Company. On January 18, 2006, Mr. O’Leary received 50,000 stock
options for work performed for the benefit of the Company. The stock
options had an exercise price of $0.26 per/share. On March, 15, 2007, Mr.
O’Leary received 100,000 warrants for certain consulting services performed for
the Company. The stock options had an exercise price of $0.26
per/share. These warrants had an exercise price of $1.49 per/share and a five
year term. Half of the warrants were deemed vested on issuance and
the other half vested ratably over a 24 month period. During 2009,
Mr. O’Leary exercised the 100,000 warrants and the 50,000 stock options in a
cash-less exercise per the terms of the agreements. The Company
issued 85,030 and 42,215 shares to settle these exercises.
During
the three months ended March 31, 2010 and 2009, George O’Leary, a director of
the Company, earned approximately $0 and $9,500, respectively, for various
consulting work performed for the Company.
Laboratory Information
System
On March
11, 2005, we entered into an agreement with HCSS, LLC and eTelenext, Inc. to
enable NeoGenomics to use eTelenext, Inc’s Accessioning Application, AP Anywhere
Application and CMQ Application. HCSS, LLC is a holding company
created to build a small laboratory network for the 50 small commercial genetics
laboratories in the United States. HCSS, LLC is owned 66.7% by Dr.
Michael T. Dent, a member of our Board of Directors. George O’Leary,
a member of our board of directors is Chief Financial Officer of HCSS,
LLC.
On June
18, 2009, we entered into a Software Development, License and Support Agreement
with HCSS, LLC and eTelenext, Inc. to upgrade the Company’s laboratory
information system to APvX. . The estimated costs for the
development and migration phase are anticipated to be approximately $75,000 and
are expected to be completed in April 2010. This agreement has an
initial term of 5 years from the date of acceptance and calls for monthly fees
of $8,000-$12,000 during the term. During the years ended December
31, 2009 and 2008, HCSS earned approximately $87,675 and approximately $99,900,
respectively, for transaction fees related to completed tests.
During
2009 eTelenext and HCSS were merged to form PathCenter, Inc. Dr.
Michael T. Dent and Mr. George O’Leary have beneficial ownership of 12.2% and
4.6%, respectively of PathCenter, Inc.
For the
three months ended March 31, 2010 and 2009, Path Center Inc. (eTelenext/HCSS)
earned approximately $69,000 and $38,000 respectively.
Gulf Pointe Capital Lease
Agreement
See Note
K to our consolidated financial statements for a description of our lease
facility with Gulf Pointe Capital, an entity with which three members of our
Board of Directors, Steven Jones, Peter Petersen and Marvin Jaffe, are
affiliated.
DESCRIPTION
OF BUSINESS
Overview
NeoGenomics
operates a network of cancer-focused testing laboratories whose mission is to
improve patient care through exceptional cancer genetic diagnostic, prognostic
and predictive testing services. Our vision is to become America’s premier
cancer testing laboratory by delivering uncompromising quality, exceptional
service and innovative products and solutions. The Company’s laboratory network
currently offers the following types of testing services:
|
a)
|
cytogenetics
testing, which analyzes human
chromosomes;
|
|
b)
|
Fluorescence
In-Situ Hybridization (“FISH”) testing, which analyzes abnormalities at
the chromosomal and gene levels;
|
|
c)
|
flow
cytometry testing, which analyzes gene expression of specific markers
inside cells and on cell surfaces;
|
|
d)
|
immunohistochemistry
testing, which analyzes the distribution of tumor antigens in specific
cell and tissue types, and
|
|
e)
|
molecular
testing which involves analysis of DNA and RNA to diagnose and predict the
clinical significance of various genetic sequence
disorders.
|
All of
these testing services are widely utilized in the diagnosis, prognosis, and
prediction for response to therapy of various types of cancers.
Market
Opportunity
The
medical testing laboratory market can be broken down into three primary
segments:
• clinical
lab testing,
• anatomic
pathology testing, and
• genetic
and molecular testing.
Clinical
laboratories are typically engaged in high volume, highly automated, lower
complexity tests on easily procured specimens such as blood and
urine. Clinical lab tests often involve testing of a less urgent
nature, for example, cholesterol testing and testing associated with routine
physical exams.
Anatomic
pathology (“AP”) testing involves evaluation of tissue, as in surgical
pathology, or cells as in cytopathology. The most widely performed AP
procedures include the preparation and interpretation of pap smears, skin
biopsies, and tissue biopsies.
Genetic
and molecular testing typically involves analyzing chromosomes, genes or DNA/RNA
sequences for abnormalities. New tests are being developed at an
accelerated pace, thus this market niche continues to expand
rapidly. Genetic and molecular testing requires highly specialized
equipment and credentialed individuals (typically MD or PhD level) to certify
results and typically yields the highest reimbursement levels of the three
market segments.
The
market for cancer testing is growing rapidly. Key factors influencing
this growth are: (i) cancer is primarily a disease of the elderly and
now that the baby boomer generation has started to turn sixty, the U.S. is
experiencing a significant increase in the number of senior citizens, (ii) the
American Cancer Society estimates that one in four senior citizens will develop
some form of cancer during the rest of their lifetime, and (iii) every year more
and more genes are discovered to have a specific link to cancer, which then
enables a genetic or molecular test to be developed. We
estimate that the Company addresses a $5-6 billion total United States market
opportunity, about half of which is derived from genetic and molecular testing
with the other half derived from more traditional anatomic pathology testing
services that are complementary to and often ordered with the genetic testing
services we offer.
Our
Focus
NeoGenomics’
primary focus is to provide high complexity laboratory testing for
community-based pathology, oncology, dermatology and urology markets in the
United States and the Caribbean. We focus on community-based practitioners for
two reasons: First, academic pathologists and associated clinicians tend to have
their testing needs met within the confines of their university affiliation.
Secondly, most of the cancer care in the United States is administered by
community based practitioners due to ease of local access. We currently provide
our services to pathologists and oncologists that perform bone marrow and/or
peripheral blood sampling for the diagnosis of blood and lymphoid tumors
(leukemias and lymphomas) and archival tissue referred for analysis of solid
tumors such as breast cancer. We also serve community-based urologists by
providing a FISH-based genetic test for the diagnosis of bladder cancer and
early detection of recurrent disease.
The high
complexity cancer testing services we offer to community-based pathologists are
designed to be a natural extension of and complementary to the services that our
pathologist clients perform within their own practices. Because fee-for-service
pathologists derive a significant portion of their annual revenue from the
interpretation of cancer biopsy specimens, they represent an important market
segment to us. We believe our relationship as a non-competitive partner to the
community-based pathologist empowers these pathologists to expand their testing
breadth and provide a menu of services that matches or exceeds the level of
service found in academic centers of excellence around the country.
We also
believe that we can provide a competitive choice to those larger oncology
practices that prefer to have a direct relationship with a laboratory for cancer
genetic testing services. Our regionalized approach allows us strong
interactions with clients and our innovative Genetic Pathology Solutions (“GPS”)
report summarizes all relevant case data on one summary report.
Competitive
Strengths
Turnaround
Times
At
NeoGenomics, we strive to provide industry leading turnaround times to our
clients nationwide and to provide information so that physicians can provide
their patients with the correct treatment as soon as possible.
We
believe our average 4-5 day turn-around time for our cytogenetics
testing services and our average 3-4 day turn-around time for FISH testing
services continue to be industry-leading benchmarks for national
laboratories. The consistent timeliness of results is a competitive
strength in cytogenetics and FISH testing and a driver of additional testing
requests by our referring physicians. Quick turn-around times for
cytogenetics and FISH tests allow for the performance of other tests to augment
or confirm results and improve patient care. Without rapid turnaround
times, there is an increased chance that the test results will not be returned
within an acceptable diagnostic window when other adjunctive diagnostic test
results are required. We believe our turn-around times result in our
referring physicians requesting more of our testing services and give us a
significant competitive advantage in marketing our services against those of
other competing laboratories.
National
Direct Sales Force
NeoGenomics
has assembled a strong direct sales force. Our sales representatives
(“Territory Business Managers”) are organized into four regions (Northeast,
Southeast, Central and West). These sales representatives are trained
extensively in cancer genetic testing and consultative selling
skills. As of April 27, 2010, we had 23 Territory Business Managers
and four Regional Managers.
Strategic
Supply Agreement with Abbott Molecular
In July 2009, we entered into a
Strategic Supply Agreement with Abbott Molecular, Inc, a wholly-owned subsidiary
of Abbott Laboratories. Under the terms of this agreement,
NeoGenomics has the rights to develop and exclusively launch three laboratory
developed tests (LDTs) based on intellectual property developed and/or licensed
by Abbott. We launched the first of these tests in February 2010, a
FISH test for the diagnosis of melanoma, and expect to launch the second test in
early 2011 and the third in 2012. In conjunction with the Strategic
Supply Agreement, Abbott Laboratories purchased a 9.6% stake in
NeoGenomics.
New
FISH Test for Melanoma
In
February 2010, we launched the first of the three tests developed pursuant to
the Strategic Supply Agreement with Abbott under the trade name
MelanoSITE™. MelanoSITE™ is a four probe FISH test that can be
used as a diagnostic aid to traditional histopathologic evaluation in diagnosing
melanoma. In conjunction with histopathology, the MelanoSITE™
test can help improve classification of melanocytic neoplasms with conflicting
morphologic criteria and help insure proper follow-up. Differential
diagnosis of moderate to severely atypical nevi versus true melanoma is one of
the most challenging areas in dermatopathology. While most melanomas
can be readily distinguished from nevi on histopathologic examination, we
estimate there are about 5% of cases that are ambiguous and show conflicting
morphologic criteria. Diagnostic ambiguity has significant adverse
consequences for patients and the healthcare system at large. Failure
to recognize melanoma is potentially fatal, but labeling a benign lesion as
malignant can lead to unwarranted wide re-excisions, sentinel lymph node
biopsies, adjuvant toxic therapeutic interventions and the emotional strain of
facing a diagnosis of cancer. Considering the large number of
biopsies done in the U.S. to either confirm or rule out melanoma, diagnostic
uncertainty of this scale represents a significant challenge to the U.S.
healthcare system. We believe the MelanoSITE™ test will help address
this diagnostic uncertainty and help to reduce the medical costs associated with
melanoma by providing a more accurate diagnosis.
The
performance characteristics of the MelanoSITE™ test were established in a
multicenter validation study involving over 500 cases, which resulted in a
sensitivity (a measure of true positives and false negatives) of 77% and a
specificity (a measure of true negatives and false positives) of
97%. Importantly, based on our study, the MelanoSITE™ test has a
negative predictive value (NPV) of over 98%. This means that
dermatopathologists and dermatologists can be confident that a patient with a
negative test result has a very low likelihood of having
melanoma. Therefore, the clinician may not need to perform a wide
re-excision of the lesion, potentially scarring a patient for life, and may not
need to perform a sentinel lymph node biopsy which can potentially lead to
further complications such as lymphedema. We expect the marketing and
selling of the MelanoSITE™ test to be a major focus of the Company during
2010.
Client
Care
NeoGenomics Customer Care Specialists
(“CCS”) are organized by region into territories that service not only our
external clients, but also work very closely with and support our sales
team. A client receives personalized assistance when dealing with
their dedicated CCS because each CCS understands their clients’ specific
needs. CCS’s handle everything from arranging specimen pickup to
delivering the results to fulfill NeoGenomics’ objective of delivering
exceptional services to our clients.
Geographic
Locations
In 2009,
we continued an aggressive campaign to regionalize our laboratory operations
around the country to be closer to our clients. Many high complexity
laboratories within the cancer testing niche have frequently operated a core
facility on one or both coasts to service the needs of their customers around
the country. We believe that our clients and prospects desire to do
business with a laboratory with national breadth and a local
presence. NeoGenomics’ has four facilities. The Chatsworth
California location is a small office laboratory for our pathologists. and we
have three main laboratory locations in Fort Myers, Florida; Irvine California;
and Nashville Tennessee and all facilities have the appropriate state licenses
and Clinical Laboratory Improvement Act, as amended (“CLIA”), and College of
American Pathologists (“CAP”) accreditations and are currently receiving
specimens. As situations dictate and opportunities arise, we will
continue to develop and open new laboratories, linked together by our optimized
Laboratory Information System (“LIS”), to better meet the regionalized needs of
our clients.
Laboratory
Information System
NeoGenomics has what we believe is a
state of the art LIS that interconnects our locations and provides flexible
reporting options to clients. This system allows us to deliver
uniform test results throughout our network, regardless of where the lab that
performs any specific test is located. This allows us to move
specimens between locations to better balance our workload. Our LIS
also allows us to offer hi