POS AM: Post-effective amendment to a registration statement that is not immediately effective upon filing
Published on May 7, 2010
As
filed with the U.S. Securities and Exchange Commission on May 7,
2010
Registration No.
333-155784
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
POST
EFFECTIVE
AMENDMENT
NO. 2
TO
FORM
S-1
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
Nevada
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NeoGenomics, Inc.
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74-2897368
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(State or Other Jurisdiction of Incorporation or
Organization) |
(Exact Name of Registrant as Specified in its
Charter) |
(I.R.S. Employer
Identification No.) |
Douglas
M. VanOort
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12701
Commonwealth Drive, Suite 9
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12701
Commonwealth Drive, Suite 9
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Fort
Myers, Florida 33913
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Fort
Myers, Florida 33913
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(239) 768-0600
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8731
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(239) 768-0600
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(Address
and Telephone Number
of
Principal Executive Office)
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(Primary
Standard Industrial
Classification
Code Number)
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(Name,
Address and Telephone Number of Agent for
Service)
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With
copies to:
Clayton
E. Parker, Esq.
Mark E.
Fleisher, Esq.
K&L
Gates, LLP
200 S.
Biscayne Boulevard, Suite 3900
Miami,
Florida 33131
Telephone:
(305) 539-3300
Facsimile:
(305) 358-7095
Approximate
date of commencement of proposed sale to the public: As soon as practicable after this
registration statement becomes effective.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, as
amended, check the following box. x
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Accelerated
filer o
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Non-accelerated
filer o (Do
not check if a smaller reporting company)
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Smaller
reporting company x
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EXPLANATORY
NOTE
The
Registrant’s Registration Statement on Form S-1 (File No. 333-155784) originally
filed with the Securities and Exchange Commission on November 28, 2008 was
declared effective on February 5, 2009 and subsequently amended by
Post-Effective Amendment No. 1 which was originally filed with the Securities
and Exchange Commission on April 28, 2009 and declared effective on May 8, 2009
(together, the “Original Registration
Statement”). The Registrant is filing this Post-Effective
Amendment No. 2 to the Original Registration Statement in order to update the
Original Registration Statement to include, among other things, the Registrant’s
audited consolidated financial statements for the fiscal year ended December 31,
2009 and unaudited consolidated financial statements for the three months ended
March 31, 2010 and other updated information about the
Registrant.
The
Registrant hereby amends this Registration Statement on such date or dates as
may be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until this Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
2
SUBJECT
TO COMPLETION, DATED MAY __, 2010.
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and we are not soliciting offers to buy these securities in any
state where the offer or sale is not permitted.
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 ________, 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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i
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:
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.
2
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.
3
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.
4
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.
5
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 $808 in 2008 due
to a higher mix on global products with interpretation and an increase of higher
revenue flow cytometry testing as a percentage of our total
revenue.
FY 2009
|
FY 2008
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% Increase
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||||||||||
Client
Requisitions Received (Cases)
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31,638 | 24,780 | 28 | % | ||||||||
Number
of Tests Performed
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45,675 | 32,539 | 40 | % | ||||||||
Average
Number of Tests/Requisition
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1.44 | 1.31 | 10 | % | ||||||||
Total
Testing Revenue
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$ | 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.
6
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.
7
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.
|
8
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
|
9
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 |
10
Balance
Sheet Data (in thousands except share data)
As of
|
||||||||
March 31, 2010
|
December 31, 2009
|
|||||||
(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 |
11
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 |
12
Balance
Sheet Data (in thousands except share data)
As of
|
||||||||
December 31,
2009 |
December 31,
2008 |
|||||||
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 |
13
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.
14
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.
15
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.
16
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.
17
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.
18
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.
19
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.
20
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.
21
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.
22
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.
23
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.
24
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.
25
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.
26
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.
Selling Stockholders
|
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).
|
27
(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.
28
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;
|
29
|
•
|
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.
|
30
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.
31
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.
32
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Introduction
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.
33
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.
34
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.
35
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:
|
·
|
Revenue
Recognition
|
|
·
|
Accounts
Receivable
|
|
·
|
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.
36
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.
37
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.
38
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.
39
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 | )% |
40
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.
41
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.
42
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.
43
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.
44
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.
45
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.
46
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.
47
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.
48
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.
49
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.
50
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.
51
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.
52
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) and 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.
FY 2009
|
FY 2008
|
% Increase
|
||||||||||
Client
Requisitions Received (Cases)
|
31,638 | 24,780 | 28 | % | ||||||||
Number
of Tests Performed
|
45,675 | 32,539 | 40 | % | ||||||||
Average
Number of Tests/Requisition
|
1.44 | 1.31 | 10 | % | ||||||||
Total
Testing Revenue
|
$ | 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.
53
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.
Number of
Employees
As of
December 31, 2009, we had 166 full-time equivalent employees. In
addition, eight other individuals, including three pathologists and a Ph.D.
cytogenetics director, serve as consultants to the Company on a regular
basis. On December 31, 2008, we had 114 full-time equivalent
employees and six consultants serving on a regular basis. Our employees are not
represented by any union and we believe our employee relations are
good.
On March
31, 2010 we had 176 full-time equivalent employees.
Government
Regulation
The
laboratory business is subject to extensive governmental regulation at the
federal, state and local levels. The laboratories are required to be
licensed by the states, certified by the federal government to participate in
the Medicare and Medicaid programs, and are subject to extensive requirements as
a condition of participation in various governmental health benefits
programs. The failure to comply with any of the applicable federal
and state laws, regulations, and reimbursement guidelines could have a material
adverse effect on the Company’s business. The applicable laws and
regulations, and the interpretations of them, change frequently and there can be
no assurance that the Company will not be subject to audit, inquiry, or
investigation with respect to some aspect of its operations. Some of
the federal and state laws and regulations are described below under "Clinical
Laboratory Operations," "Anti-Fraud and Abuse Laws," “The False Claims Act,”
"Confidentiality of Health Information," and "Food and Drug
Administration".
54
Clinical Laboratory
Operations
Licensure
and Accreditation
The
Company operates clinical laboratories in Fort Myers, Florida, Nashville,
Tennessee, Irvine, California and Chatsworth, California. The Chatsworth
California location is a small office laboratory for our pathologists. The
laboratories are licensed as required by the states in which they are
located. In addition, the laboratory in Tennessee is licensed by the
State of New York as it accepts clinical specimens obtained in New
York. All of the NeoGenomics laboratories are certified in accordance
with the Clinical Laboratories Improvement Act, as amended
(“CLIA”). Under CLIA, the U.S. Department of Health and Human
Services (“HHS”) establishes quality standards for each category of testing
performed by the laboratory. The categories of testing include
waived, moderate complexity, and high complexity. NeoGenomics’ laboratories are
categorized as high complexity. The NeoGenomics’ laboratories are
also accredited by the College of American Pathologists (“CAP”) and actively
participate in CAP’s proficiency testing programs for all tests offered by the
Company. Proficiency testing programs require the participating laboratories to
test specimens that they receive from the testing entity and return the results.
The testing entity, conducting an approved program, analyzes the results
returned and provides to the Company a quality control report assessing the
results. An important component of a quality assurance program is to
establish whether the laboratory’s test results are accurate and
valid.
The
federal and state certification and licensure programs establish standards for
the operation of clinical laboratories, including, but not limited to,
qualifications of personnel and quality control. Compliance with such standards
is verified by periodic inspections by inspectors employed by federal and state
regulatory agencies and accrediting organizations. The Company’s
Quality Assurance team, which is comprised of representatives of all departments
of the Company, also conducts routine internal surveys and requires corrective
actions in response to the findings.
Quality
of Care
Our
mission is to improve patient care through quality cancer genetic diagnostic
services. By delivering exceptional service and innovative solutions, we aspire
to become America’s premier cancer testing laboratory. The quality of
care provided to clients and their patients is of paramount importance to
us. We maintain strong quality control processes, including standard
operating procedures, controls, performance measurement and reporting
mechanisms. Our employees are committed to providing accurate,
reliable, and consistent services at all times. Any concerns
regarding the quality of testing or services provided by the Company are
immediately communicated to Company management and, if necessary, the Compliance
Department or Human Resources Department.
Compliance
Program
The
health care industry is highly regulated and scrutinized with respect to fraud,
abusive billing practices, and improper financial relationships between health
care companies and their referral sources. The Office of the
Inspector General of HHS (the “OIG”) has published compliance guidance,
including the Compliance Program Guidance for Clinical Laboratories in August of
1998, and advisory opinions. The Company has implemented a Compliance
Program that is overseen by the senior management of the Company. Its
objective is to ensure compliance with the myriad federal and state laws,
regulations and governmental guidance applicable to our business. Our
program consists of training/education of employees and monitoring and auditing
Company practices. The Board of Directors has formed a Compliance Committee
which meets regularly to discuss all compliance-related issues that may affect
the Company. The Company continuously reviews its policies and procedures as new
regulations and interpretations come to light to comply with applicable
regulations.
Hotline
As part
of its Compliance Program, the Company provides a hotline for employees who wish
to anonymously or confidentially report suspected violations of our codes of
conduct, policies/procedures, or laws and regulations. Employees are strongly
encouraged to report any suspected violation if they do not feel the problem can
be appropriately addressed through the normal chain of command. The hotline does
not replace other resources available to Employees, including supervisors,
managers and human resources staff, but is an alternate channel available 24
hours a day, 365 days a year. The hotline forwards all reports to the Compliance
Officer who is responsible for investigating, reporting to the Compliance
Committee, and documenting the disposition of each report. The hotline forwards
any calls pertaining to the financial statements or financial issues to the
Chair of the Audit Committee. The Company does not allow any retaliation against
an employee who reports a compliance related issue.
55
Anti-Fraud and Abuse
Laws
The
federal laws governing Medicare, Medicaid, and other federal health benefits, as
well as other state and federal laws, regulate certain aspects of the
relationships between health care providers, including clinical laboratories,
and their referral sources, including physicians, hospitals, other laboratories,
and other entities. The federal anti-kickback laws, referred to as the Medicare
and Medicaid Anti-Fraud and Abuse Amendments to the Social Security Act (the
“Anti-Kickback Statute”), prohibit any knowing and willful offer, payment,
solicitation or receipt of any form of remuneration, either directly or
indirectly, in return for, or to induce: (i) the referral of an individual for a
service for which payment may be made by Medicare and Medicaid or other federal
health benefit programs; or (ii) the purchasing, leasing, ordering or arranging
for, or recommending the purchase, lease or order of, any service or item for
which payment may be made by Medicare, Medicaid or other federal health benefit
programs. Violations of federal anti-kickback laws and regulations
are punishable as a felony, by civil money penalties, and exclusion from
participation in Medicare, Medicaid and other federal health benefit
programs. Most states have similar laws with both criminal and civil
penalties.
Because
of the broad proscriptions of the Anti-Kickback Statute, subsequent federal law
required the HHS to publish regulations to guide the health care community in
structuring relationships that would not violate the law. The OIG
published regulations outlining certain categories of relationships between
health care providers and persons or entities that may have a referral
relationship that would be deemed not to violate the Anti-Kickback
Statute. These regulations are known as the Safe Harbor Regulations
(the “Safe Harbor Regulations”) because persons who enter into transactions that
comply with all of the criteria for an applicable safe harbor will not be
subject to prosecution under the Anti-Kickback Statute. The Safe Harbor
Regulations are narrowly drafted to avoid inadvertently immunizing prohibited
conduct. A relationship or transaction that does not meet all of the criteria of
an applicable Safe Harbor Regulation is not deemed to be illegal. Rather it may
be subject to additional scrutiny. The Company endeavors to comply with the Safe
Harbor Regulations, but there can be no assurance that the Company would not be
subject to investigation and, if investigated, that relationships could be found
not to comply with the Safe Harbor Regulations.
Medicare Payment
Guidelines
The
Company has various billing arrangements with its clients and with third party
payors, including the Medicare program. The Company may perform the entire test
and render a professional interpretation in which case the Company would bill
globally, for both the technical and professional components, either directly to
the payor or to the client. Alternatively, the Company may perform
the technical component of the test only and either bill the payor directly or
bill the client. Client billing arrangements are priced competitively
at fair market value. These client billing arrangements may implicate
the prohibition of the Medicare program against charging the Medicare or
Medicaid programs fees substantially in excess of the Company’s usual and
customary charges. These billing arrangements may also implicate the
federal Stark Law and the federal and state anti-kickback statutes.
Federal
law authorizes the Secretary of HHS to suspend or exclude providers from
participation in the Medicare and Medicaid programs if they charge Medicare or
state Medicaid programs fees "substantially in excess" of their "usual
charges." The OIG has stated in commentary to various final and
proposed regulations its position that this statute has limited applicability to
the current Medicare reimbursement system which either mandates prospective
payment or provides for services to be reimbursed based on a fee
schedule. The OIG indicated, in the Federal Register of September 2,
1998, that it would expect the statutory authority to exclude providers based on
a determination that their fees were substantially in excess of their usual
charges would “have declining relevance within the Medicare reimbursement
system.” However, in the Federal Register of September 15, 2003, the
OIG requested, in a Notice of Proposed Rule-Making, comments as to whether any
services reimbursed under the physician fee schedule should be subject to these
regulations. The OIG further stated that “[w]e note that ancillary
services, such as laboratory tests and drugs, would remain subject to these
regulations, even when furnished by physicians” [F.R., Vol. 68, No. 178,
September 15, 2003 at 53940]
In
several Advisory Opinions, the OIG has provided additional guidance regarding
the possible application of this law, as well as the applicability of the
anti-kickback laws to pricing arrangements. The OIG concluded in an Advisory
Opinion issued in 1999 [OIG Advisory Opinion No. 99-13] that an arrangement
under which a laboratory offered substantial discounts to physicians for
laboratory tests billed directly to the physicians could potentially trigger the
"substantially in excess" provision and might violate the anti-kickback law,
because the discounts could be viewed as being provided to the physician in
exchange for the physician's referral to the laboratory of non-discounted
Medicare business, unless the discounts could otherwise be
justified.
56
The
Centers for Medicare and Medicaid Services promulgated, in 2008, a revision to
the regulation that prohibits the mark up of purchased diagnostic services [42
C.F.R. §414.50] (the “Anti-Markup Rule”). The Anti-Markup Rule
prohibits a physician or other supplier from billing for the technical or
professional component of a diagnostic test that was ordered by the physician or
supplier and was performed by a physician who does not share a practice with the
billing physician or supplier an amount greater than the lesser of: (i) the
performing supplier’s net charge to the billing physician; (ii) the billing
physician’s actual charge; or (iii) the fee schedule amount for the test that
would be allowed if the performing supplier billed directly. There
has been considerable commentary and the regulation has been amended to attempt
to clarify the regulation.
In light
of the various federal regulations and guidance from the OIG, the Company
endeavors to price its products competitively while endeavoring to meet
applicable statutes and regulations.
Physician Self Referral
Laws
The
federal law referred to as the "Stark Law”, named after Rep. Fortney “Pete”
Stark, prohibits physicians who have a financial relationship with an entity
from referring Medicare and Medicaid patients to that entity for the provision
of designated health services unless the transaction meets an exception to the
law. The Company is subject to the Stark law in that laboratory
services are classified as a designated health service. The
prohibited financial relationships include investment and compensation
arrangements.
Some
states in which the Company is engaged have enacted similar physician
self-referral laws. For example, the Florida Patient Self-Referral Act of 1992,
as amended, (the “Act”) is similar to the Stark law, but is narrower in some
respects and broader in others. Clinical laboratory services are similarly
classified as a designated health service in the Act. But, the Act applies to
investment interests, and, unlike the Stark Law, does not address compensation
arrangements. The penalties for a violation of the Act include forfeiture of all
payments received, civil money penalties, and disciplinary action by the
applicable licensing board.
The Stark
Law is a per se statute
in that intent to violate the statute, unlike the Anti-Kickback Statute, is
immaterial. A violation of the Stark Law renders any reimbursements
improper and requires the provider to forfeit any funds received in violation of
the Stark Law, and exposes the parties to civil and criminal penalties. The
Company endeavors to structure its financial relationships in compliance with
the Stark Law and with similar state physician self-referral laws.
The False Claims
Act
The
Federal False Claims Act prohibits any person or entity from knowingly
presenting, or causing to be presented, to the U.S. government, or to a Medicare
program contractor, a false or fraudulent claim for payment, or knowingly making
or using a false record or statement to have a false claim paid by the
government, or conspiring to defraud the U.S. government, or knowingly making or
using a false statement to conceal and obligation to pay the
government. A violation of the Federal False Claims Act is punishable
by a civil penalty of $5,500 to $11,000 plus three times the amount of
damages. Private parties may bring an action on behalf of the U.S.
Government by filing a qui
tam case. The private party, called a relator, is entitled to
a share of the proceeds from any recovery or settlement. As most
qui tam cases are filed
by current or former employees, an effective compliance program plays a crucial
role in reducing the Company’s exposure to liability. It is also a
criminal offense, under Title 18 U.S. Code, Section 287, for a person or entity
to make a claim against the United States or any department or agency, knowing
the claim to be false, fictitious or fraudulent. The penalty is
imprisonment of not more than five years. The Federal False Claims Act has been
an effective enforcement tool for the federal government. Many states have
enacted similar false claims acts as well.
The
Company seeks to structure its arrangements with physicians and other clients to
be in compliance with the Anti-Kickback Statute, Stark Law, state laws, and the
Federal False Claims Act and to stay abreast of current developments and changes
in the law and regulations. However, these laws and regulations are
complex and subject to interpretation. Consequently, we are unable to
ascertain with certainty that any of our transactions will not be subject to
scrutiny and, if scrutinized, will not result in sanctions or
penalties. The Company has taken and will continue to take actions to
endeavor to ensure compliance with the myriad federal and state laws that govern
our business.
Confidentiality and Security
of Personal Health Information
The
Health Insurance Portability and Accountability Act of 1996, as amended
("HIPAA") contains provisions that protect individually identifiable health
information from unauthorized use or disclosure by covered entities and their
business associates. The Office of Civil Rights of HHS, the agency responsible
for enforcing HIPAA, has published regulations to address the privacy (the
“Privacy Rule”) and security (the “Security Rule”) of protected health
information (“PHI”). The Company is a covered entity and has adopted
policies and procedures to comply with the Privacy Rule and the Security Rule.
The health care facilities and providers that refer specimens to the Company are
also bound by HIPAA.
57
HIPAA
also required that all providers who transmit claims for health care goods or
services electronically utilize standard transaction and data sets and to
standardize national provider identification codes. The Company has taken
necessary steps to comply with HIPAA regulations, utilizes standard transaction
data sets, and has obtained and implemented national provider identifiers, or
NPIs, as the standard unique health identifier in filing and processing health
care claims and other transactions.
The
American Recovery and Reinvestment Act (“ARRA”) recently enacted the HITECH Act
which extends the scope of HIPAA to permit enforcement against business
associates for a violation, establishes new requirements to notify the Office of
Civil Rights of HHS of a breach of HIPAA, and allows the Attorneys General of
the states to bring actions to enforce violations of HIPAA. Rules
implementing various aspects of HIPAA are continuing to be
developed.
In
addition to the HIPAA Privacy Rule and Security Rule described above, the
Company is subject to state laws regarding the handling and disclosure of
patient records and patient health information. These laws vary widely.
Penalties for violation include sanctions against a laboratory's licensure as
well as civil or criminal penalties. Additionally, private
individuals may have a right of action against the Company for a violation of a
state’s privacy laws. We believe we are in material compliance with
current state laws regarding the confidentiality of health information and will
continue to monitor and comply with new or changing state laws.
The Fair
and Accurate Credit Transactions Act of 2003, enacted on Dec. 4, 2003, directed
the Federal Trade Commission to implement regulations to protect consumers
against identity theft. The Federal Trade Commission issued what are
referred to as the “Red Flag Rules”, but the effective date for enforcement has
been delayed several times. The Red Flag Rules are now subject to enforcement as
of June 1, 2010. Health care providers who act as a “creditor” to any of its
patients with respect to a “covered account” are required to implement an
identity theft protection program to safeguard patient information. A
creditor includes any entity that regularly extends, renews or continues credit
or which defers payment for goods or services. Since the Company routinely
extends credit by billing for its services after such services are provided, the
Company meets the definition of a “creditor” under the Red Flag Rules.
Accordingly, the Company has developed a written program designed to identify
and detect the relevant warning signs – or “red flags” – of identity theft and
establish appropriate responses to prevent and mitigate identity theft in order
to comply with the Red Flag Rules. We are also developing a plan to update the
program, and the program will be managed by senior management staff under the
policy direction of our Board of Directors. The Company intends to take such
steps as necessary to determine the extent to which it may be covered by the Red
Flag Rule and take such steps as necessary to comply.
History
On
October 29, 1998, the Parent Company was incorporated in the State of Nevada as
American Communications Enterprises, Inc. The Parent
Company changed its name to Neogenomics, Inc. on December 14, 2001.
Properties
We
operate a regional network of laboratories. All our
facilities are leased and we believe that they are sufficient to meet our needs
for the foreseeable future and that, if needed, additional space will be
available at a reasonable cost. The following table summarizes our
facilities by location:
Location
|
Purpose
|
Square footage
|
||
Fort
Myers, Florida
|
Corporate
headquarters and laboratory
|
25,700
|
||
Irvine,
California
|
Laboratory
|
14,800
|
||
Chatsworth,
California
|
Pathology
Laboratory
|
1,200
|
||
Nashville,
Tennessee
|
Laboratory
|
5,400
|
Legal
Proceedings
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.
58
MANAGEMENT
Officers
And Directors
The
following table sets forth the names, ages, and titles of each of our directors
and executive officers and employees expected to make a significant contribution
to us as of April 27, 2010.
Name
|
Age
|
Position
|
||
Board of Directors:
|
||||
Douglas
VanOort
|
54
|
Chairman
of the Board of Director’s and Chief Executive Officer,
|
||
Robert
P. Gasparini
|
55
|
President
and Chief Science Officer, Board Member
|
||
Steven
C. Jones
|
47
|
Executive
Vice President of Finance, Board Member
|
||
Michael
T. Dent
|
45
|
Board
Member
|
||
George
G. O’Leary
|
47
|
Board
Member
|
||
Peter
M. Peterson
|
53
|
Board
Member
|
||
Marvin
E. Jaffe
|
73
|
Board
Member
|
||
William
J. Robison
|
73
|
Board
Member
|
||
Other Executives:
|
||||
George
Cardoza
|
48
|
Chief
Financial Officer
|
||
Jack
G. Spitz
|
54
|
Vice
President of Laboratory Operations
|
||
Grant
Carlson
|
42
|
Vice
President of Sales and Marketing
|
||
Matthew
William Moore
|
36
|
Vice
President of Research and Development
|
||
Jerome
J. Dvonch
|
|
41
|
|
Director
of Finance and Principal Accounting
Officer
|
Family
Relationships
There are
no family relationships between or among the members of the Board of Directors
or other executives.
Legal
Proceedings
None of
the members of the Board of Directors or other executives has been involved in
any bankruptcy proceedings, criminal proceedings, any proceeding involving any
possibility of enjoining or suspending members of our Board of Directors or
other executives from engaging in any business, securities or banking
activities, and have not been found to have violated, nor been accused of having
violated, any federal or state securities or commodities laws.
Elections
Members
of our Board of Directors are elected at the annual meeting of stockholders and
hold office until their successors are elected. Our officers
are appointed by the Board of Directors and serve at the pleasure of the Board
and are subject to employment agreements, if any, approved and ratified by the
Board.
The
Company, Michael Dent, Aspen, John Elliot, Steven Jones and Larry Kuhnert are
parties to the Amended and Restated Shareholders’ Agreement dated March 21,
2005, as amended, that, among other provisions, gives Aspen, our largest
stockholder, the right to elect three out of the eight directors authorized for
our Board of Directors, and to nominate one mutually acceptable independent
director. In addition, Michael Dent and the executive management of
the Company has the right to elect one director for our Board of Directors,
until the earlier of (i) Dr. Dent’s resignation as an officer or director of the
Company or (ii) the sale by Dr. Dent of 50% or more of the number of
shares of our common stock that he held on March 21, 2005.
Douglas M. VanOort, – Chairman
of the Board of Directors and Chief Executive Officer
Mr.
VanOort has served as the Chairman of the Board of Directors and Chief Executive
Officer of NeoGenomics since October 28, 2009. Prior to that he
served as Chairman of the Board of Directors, Executive Chairman and Interim
Chief Executive Officer from March 2009 to October 2009. He has been
an Operating Partner with Summer Street Capital Partners since 2004 and a
Founding Partner of Conundrum Capital Partners since 2000. From 1995
to 1999, he served as the Senior Vice President Operations for Quest
Diagnostics, Incorporated. During this period Quest Diagnostics grew
to approximately $1.5 billion in annual revenue through both organic growth and
mergers and acquisitions. From 1982 to 1995, Mr. VanOort served in
various positions at Corning Incorporated and ultimately held the position of
Executive Vice President and CFO of Corning Life Sciences, Inc. In
1995, Corning spun off Corning Life Sciences, Inc. into two companies, Quest
Diagnostics and Covance, Inc. Mr. VanOort serves as a member of the
Board of Directors of Palladian Health, International Climbing Machines, Inc.
and Bio HiTech, Inc. In addition, since 2000, Mr. VanOort has served
as the Chairman, Co-Founder and Co-Owner of Vision Ace Hardware, LLC, a retail
hardware chain. Mr. VanOort is a graduate of Bentley
College.
59
Robert P. Gasparini, M.S. –
President and Chief Science Officer, Board Member
Mr.
Gasparini has served as the President and Chief Science Officer of NeoGenomics
since January 2005. Prior to assuming the role of President and Chief
Science Officer, Mr. Gasparini was a consultant to the Company beginning in May
2004. Prior to NeoGenomics, Mr. Gasparini was the Director of the
Genetics Division for US Pathology Labs, Inc. (“US Labs”) from January 2001 to
December 2004. During this period, Mr. Gasparini started the Genetics
Division for US Labs and grew annual revenues of this division to $30 million
over a 30 month period. Prior to US Labs, Mr. Gasparini was the
Molecular Marketing Manager for Ventana Medical Systems from 1999 to
2001. Prior to Ventana, Mr. Gasparini was the Assistant Director of
the Cytogenetics Laboratory for the Prenatal Diagnostic Center from 1993 to 1998
an affiliate of Massachusetts General Hospital and part of Harvard
University. While at the Prenatal Diagnostic Center, Mr. Gasparini
was also an Adjunct Professor at Harvard University. Mr. Gasparini is
a licensed Clinical Laboratory Director and an accomplished author in the field
of Cytogenetics. He received his BS degree from The University of
Connecticut in Biological Sciences and his Master of Health Science degree from
Quinnipiac University in Laboratory Administration.
Steven C. Jones – Executive
Vice President Finance, Board Member
Mr. Jones
has served as a director since October 2003 and as Executive Vice President of
Finance since November 30, 2009. Mr. Jones served as Chief Financial
Officer for the Company prior to November 30, 2009. He is a Managing
Director in Medical Venture Partners, LLC, a venture capital firm established in
2003 for the purpose of making investments in the healthcare
industry. Mr. Jones is also the co-founder and Chairman of the Aspen
Capital Group and has been President and Managing Director of Aspen Capital
Advisors since January 2001. Prior to that Mr. Jones was a chief
financial officer at various public and private companies and was a Vice
President in the Investment Banking Group at Merrill Lynch &
Co. Mr. Jones received his B.S. degree in Computer Engineering from
the University of Michigan in 1985 and his MBA degree from the Wharton School of
the University of Pennsylvania in 1991. He is also Chairman of the Board of T3
Communications, Inc. and serves on the Board of Directors of Disc Motion
Technologies, Inc.
Michael T. Dent M.D. – Board
Member
Dr. Dent
is our founder and a director. Dr. Dent was our President and Chief Executive
Officer from June 2001, when he founded NeoGenomics, to April
2004. From April 2004 until April 2005, Dr. Dent served as our
President and Chief Medical Officer. Dr. Dent founded the Naples
Women's Center in 1996 and continues his practice to this day. He
received his training in Obstetrics and Gynecology at the University of Texas in
Galveston. He received his M.D. degree from the University of South Carolina in
Charleston, South Carolina in 1992 and a B.S. degree from Davidson College in
Davidson, North Carolina in 1986. He is a member of the American Association of
Cancer Researchers and a Diplomat and fellow of the American College of
Obstetricians and Gynecologists. He sits on the Board of the Florida
Life Science Biotech Initiative.
George G. O’Leary – Board
Member
Mr.
O’Leary is a director of NeoGenomics and is currently running his own consulting
firm, SKS Consulting of South Florida Corp. where he consults for NeoGenomics as
well as several other companies. Mr. O’Leary is also a board member
of NeoMedia Technologies, Inc, and is Chairman of the Board of Directors of
Isonics Corporation. He is also acting CFO for Isonics
Corporation. Prior to that he was President of US Medical
Consultants, LLC. Prior to assuming his duties with US Medical, he
was a consultant to the Company and acting Chief Operating Officer. Prior to
NeoGenomics, Mr. O’Leary was the President and CFO of Jet Partners, LLC from
2002 to 2004. During that time he grew annual revenues from $12 million to $17.5
million. Prior to Jet Partners, Mr. O’Leary was CEO and President of
Communication Resources Incorporated (CRI) from 1996 to 2000. During
that time he grew annual revenues from $5 million to $40 million. Prior to CRI,
Mr. O’Leary held various positions including Vice President of Operations for
Cablevision Industries from 1987 to 1996. Mr. O’Leary was a CPA with Peat
Marwick Mitchell from 1984 to 1987. He received his BBA in Accounting from Siena
College in Albany, New York.
60
Peter M. Peterson – Board
Member
Mr.
Peterson is a director of NeoGenomics and is the founder of Aspen Capital
Partners, LLC which specializes in capital formation, mergers &
acquisitions, divestitures, and new business start-ups. Prior to
forming Aspen Capital Partners, Mr. Peterson was Managing Director of Investment
Banking with H. C. Wainwright & Co. Prior to Wainwright, Mr.
Peterson was president of First American Holdings and Managing Director of
Investment Banking. Prior to First American, he served in various
investment banking roles and was the co-founder of ARM Financial
Corporation. Mr. Peterson was one of the key individuals responsible
for taking ARM Financial public on the OTC market and the American Stock
Exchange. Under Mr. Peterson’s financial leadership, ARM Financial
Corporation was transformed from a diversified holding company into a national
clinical laboratory company with 14 clinical laboratories and ancillary services
with over $100 million in assets. He has also served as an officer or
director for a variety of other companies, both public and
private. Mr. Peterson earned a Bachelor of Science degree in Business
Administration from the University of Florida.
Marvin E. Jaffe, MD – Board
Member
Dr. Jaffe, who is retired, spent his
entire working career in the pharmaceutical industry and has been responsible
for the pre-clinical and clinical development of new drugs and biologics in
nearly every therapeutic area. He began his career at Merck & Co and spent
18 years with Merck, rising to the position of Senior Vice-President of Medical
Affairs. After leaving Merck, Dr. Jaffe became the founding President of the
R.W. Johnson Pharmaceutical Research Institute (PRI), a Johnson & Johnson
Company. PRI was established for the purpose of providing globally integrated
research and development support to several companies within the J&J
pharmaceutical sector. Dr. Jaffe retired from Johnson & Johnson
in 1994 and currently serves as a consultant and board member to the
biopharmaceutical and biotechnology industries. He was on the Board of
Immunomedics, Inc., and on the Boards of Genetic Therapy, Inc., Vernalis Group,
plc., Celltech Group, plc. and Matrix Pharmaceuticals which were acquired by
other companies. He is on the Scientific Advisory Boards of the Seaver
Foundation and the Jefferson Medical College Hospital for
Neuroscience. He is a partner of Naimark Associates which consults to
the biopharmaceutical industry.
William J. Robison – Board
Member
Mr. Robison, who is retired, spent his
entire 40 year career with Pfizer, Inc. At Pfizer, he rose through the ranks of
the sales organization and became Senior Vice President of Pfizer Labs in 1986.
In 1990, he became General Manager of Pratt Pharmaceuticals, a then new division
of the U.S. Pharmaceuticals Group, and in 1992 he became the President of the
Consumer Health Care Group. In 1996 he became a member of Pfizer’s Corporate
Management Committee and was promoted to the position of Executive Vice
President and head of Worldwide Corporate Employee Resources. Mr. Robison
retired from Pfizer in 2001 and currently serves as a consultant and board
member to various companies. Mr. Robison is a board member and an executive
committee member of the USO of Metropolitan New York, Inc. He is also on the
board of Trustees at the University of Louisiana-Monroe foundation, a member of
the Human Resources Roundtable Group, the Pharmaceutical Human Resource Council,
the Personnel Round Table, and on the Employee Relations Steering Committee for
The Business Round Table.
George Cardoza – Chief
Financial Officer
Mr. Cardoza has served as Chief
Financial Officer since November 2009. Prior to that from March 2008
to November 2009, Mr. Cardoza served as the Chief Financial Officer of Protocol
Global Solutions, Inc., a privately held international marketing company. Mr.
Cardoza also served as the Controller of Protocol Global Solutions from March
2006 to March 2008. From April 1991 to March 2006, Mr. Cardoza was employed by
Quest Diagnostics Inc., a diagnostic testing, information and services company,
in a number of positions, including the position of Controller—Central Region
from 2001 to March 2006. At Quest Mr. Cardoza was responsible for
overseeing all the financial operations of the Central Region, which had sales
of over $1.2 billion in 2006. Prior to his time with Quest, he worked
for Sony Music Entertainment Inc. and the Continental Grain Company in various
financial roles. Mr. Cardoza received his B.S. from Syracuse
University in finance and accounting and has received his M.B.A. from Michigan
State University.
Jack G. Spitz – Vice President
of Laboratory Operations
Mr. Spitz has served as Vice President
of Laboratory Operations since December 2009. Prior to that Mr. Spitz
most recently served as Executive Director of Operations for Dermpath
Diagnostics, a division of Quest Diagnostics, and formerly a division of
Ameripath, Inc., where he was responsible for running operations of five (5)
dermatopathology laboratories across the Southeast United States. Prior to
joining Ameripath in 2006, Mr. Spitz was employed by Genova Diagnostics, an
international esoteric clinical laboratory, as Director of Laboratory Operations
from 2000 to 2006. While at Genova Diagnostics, in addition to operational
responsibilities, Mr. Spitz was also involved in many R&D projects,
including ground up development of a genetic testing laboratory and he was
responsible for the transition of tests from R&D to operations. Mr. Spitz
received a B.A. degree in Pharmacy from the Medical University of South Carolina
and a B.A. degree in Microbiology from the University of South
Florida.
61
Grant Carlson – Vice President
of Sales and Marketing
Mr. Carlson has served as Vice
President of Sales and Marketing since July 2009. Mr. Carlson had
previously served as a consultant to the Company since December
2008. Prior to that Mr. Carlson served as the President and Chief
Executive Officer of Calgenex Corporation, a nutraceutical company which he
co-founded, from March 2006 to June 2008. From April 2004 to February
2006, Mr. Carlson served as President and Chief Operating Officer of Nanobac
Pharmaceuticals Incorporated, a pharmaceutical and diagnostic
company. Mr. Carlson served as Vice President, Marketing and Business
Development of Agilix Corporation, a functional genomics company, from April
2001 to April 2004. From January 1989 to April 2001, Mr. Carlson was
employed by Dianon Systems, Inc., an anatomic pathology laboratory, lastly in
the position of Vice President, Marketing & Business
Development. Mr. Carlson received a B.S. degree in Kinesiology from
the University of California, Los Angeles.
Matthew William Moore, Ph.D. –
Vice President of Research and Development
Mr. Moore has served as Vice President
of Research and Development since July 2006. Prior to that he served as Vice
President of Research and Development for Combimatrix Molecular Diagnostics, a
subsidiary of Combimatrix Corporation, a biotechnology company, developing novel
microarray, Q-PCR and Comparative Genomic Hybridization based diagnostics. Prior
to Combimatrix Molecular Diagnostics, he served as a senior scientist with US
Labs, a division of Laboratory Corporation of America (LabCorp) where he was
responsible for the initial implementation of the Molecular in Situ Hybridization and
Molecular Genetics programs. Mr. Moore received his Bachelors of Science degree
in Biotechnology, where he graduated with honors and his doctoral degree from
the University of New South Wales, Australia.
Jerome J. Dvonch – Director of
Finance, Principal Accounting Officer
Mr. Dvonch has served as Director of
Finance since August 2005 and as Principal Accounting Officer since August
2006. From June 2004 through July 2005, Mr. Dvonch was Associate
Director of Financial Planning and Analysis with Protein Design Labs, a
bio-pharmaceutical company. From September 2000 through June 2004,
Mr. Dvonch held positions of increasing responsibility including Associate
Director of Financial Analysis and Reporting with Exelixis, Inc., a
biotechnology company. He also was Manager of Business Analysis
for Pharmchem Laboratories, a drug testing laboratory. Mr. Dvonch is
a Certified Public Accountant and received his M.B.A. from the Simon School of
Business at the University of Rochester. He received his B.B.A. in
accounting from Niagara University.
Nomination
Criteria
Members of our board of directors were
nominated to serve as directors based on reasons that included among others,
their experience in health related businesses or their business acumen as
described above in their biographies.
Audit
Committee
Currently,
the Audit Committee of the Board of Directors is comprised of Mr. Petersen and
Mr. O’Leary. Neither Mr. Petersen nor Mr. O’Leary are considered to be
“independent” pursuant to NASDAQ Listing Rule 5605.
Compensation
Committee
The
Compensation Committee is comprised of Mr. Robison, Mr. Jones, and Dr.
Dent. Mr. Jones and Dr. Dent are not considered “independent” as that
term is defined by NASDAQ Listing Rule 5605.
Compliance
Committee
The Compliance Committee is comprised
of Mr. Jones and Dr. Jaffe. Mr. Jones and Dr. Jaffe are not
considered “independent” as that term is defined by NASDAQ Listing Rule
5605. Mr. Jones is the chair of the compliance
committee.
62
Independent
Directors
Mr. O’Leary and Mr. Robinson are
considered to be “independent” as that term is defined by NASDAQ Listing Rule
5605.
Executive
Compensation
Summary Compensation Table
The
following Summary Compensation Table sets forth all compensation earned and
accrued, in all capacities, during the fiscal years ended December 31, 2009 and
2008, by our Named Executive Officers.
Name and
Principal Position
|
Year
|
Salary
|
Bonus
|
Stock
Award
|
Option
Award(1)
|
Non-Equity
Incentive
Plan
Compensation
|
Non-
qualified
Deferred
Compensation
Earnings
|
All Other
Compensation
|
Total
|
|||||||||||||||||||||||||
Douglas
VanOort (3)
|
2009
|
$ | 218,846 | $ | 37,500 | $ | - | $ | 203,479 | $ | - | $ | - | $ | - | $ | 459,825 | |||||||||||||||||
Chief
Executive
Officer
and Chairman
of
the Board
|
||||||||||||||||||||||||||||||||||
Robert
P. Gasparini
|
2009
|
$ | 249,968 | $ | 20,000 | $ | - | $ | 72,372 | $ | - | $ | - | $ | - | $ | 342,340 | |||||||||||||||||
President
and Chief
|
2008
|
$ | 235,872 | $ | 35,000 | $ | - | $ | 89,985 | $ | - | $ | - | $ | 360,857 | |||||||||||||||||||
Science
Officer
|
||||||||||||||||||||||||||||||||||
Grant
Carlson(2)
|
2009
|
$ | 97,569 | $ | 12,000 | $ | - | $ | 23,570 | $ | - | $ | - | $ | 110,802 | $ | 243,941 | |||||||||||||||||
V.P.
of Sales and
|
2008
|
$ | - | $ | - | $ | - | $ | - | $ | - | $ | - | $ | 17,517 | $ | 17,517 | |||||||||||||||||
Marketing
|
(1)
|
See
Item 8, Note F for a description on the valuation methodology of stock
option awards and warrants. Mr. VanOort was granted warrants to
purchase 625,000 shares of common stock and the stock compensation expense
related to these warrants has been included in option
awards.
|
(2)
|
Mr.
Carlson acted as a consultant to the Company from December 2008 until his
hire date in July 2010 and received $105,102 for those services and he
also received a $4,200 car allowance and a $1,500 cell phone
allowance.
|
(3)
|
Mr.
VanOort began in March 2009 as Executive Chairman and Interim Chief
Executive Officer and began as full time Chief Executive Officer in
October 2009.
|
63
Outstanding
Equity Awards at Fiscal Year End
The
following table sets forth information with respect to outstanding equity awards
held by our named executive officers as of December 31, 2009.
Option Awards
|
||||||||||||||||||
Name and
Principal Position
|
Number of
Securities
Underlying
Unexercised
Options
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options Un-exercisable
|
Equity Incentive
Plan Awards-Number of
Securities
Underlying
Unexercised &
Unearned
Options
|
Option
Exercise
Price
|
Option
Expiration
Date
|
|||||||||||||
Doug
VanOort
|
200,000 | 800,000 | (1) | - | $ | 0.80 |
3/15/2016
|
|||||||||||
Chief
Executive
Officer
and Chairman
of
the Board of
Directors
|
||||||||||||||||||
Robert P.
Gasparini
|
575,000 | - | 175,000 | 0.25 |
1/1/2015
|
|||||||||||||
President
and Chief
|
100,000 | - | 150,000 | 1.47 |
2/13/2017
|
|||||||||||||
Science
Officer
|
292,000 | 292,000 | (2)(3) | 200,000 | 0.80 |
3/12/2015
|
||||||||||||
50,000 | 100,000 | (3) | 50,000 | 0.62 |
2/9/2019
|
|||||||||||||
Grant
Carlson
|
18,750 | 131,250 | (1) | - | 1.32 |
7/22/2014
|
||||||||||||
V.P.
of Sales and
|
||||||||||||||||||
Marketing
|
(1)
|
Please
see Note G of the consolidated financial statements for a vesting
detail.
|
(2)
|
288,000
of the options are time-based and vest monthly from January 2009 through
December 2011; the remaining 300,000 options have annual performance
measures that are tied to each of the next three
years.
|
(3)
|
Relates
to a cancelation of certain performance options which resulted in a new
option grant of performance
options.
|
64
Director
Compensation
Each of
our non-employee directors is entitled to receive cash
compensation. As of December 31, 2009 the reimbursement was as
follows:
|
·
|
$1,000
for each board meeting physically
attended
|
|
·
|
$500
for each board meeting attended via conference
call
|
|
·
|
$5,000
for each calendar quarter served as
director
|
|
·
|
$150
per hour for all hours worked as part of any
committee
|
We also
reimburse our directors for out of pocket expenses incurred in connection with
attendance at board and committee meetings. The following table
provides information concerning the compensation of our directors for the year
ended December 31, 2009.
Name
|
Fees
Earned or
Paid in
Cash
|
Stock
Awards
|
Warrant/
Option
Awards(1)
|
Non-Equity
Incentive Plan
Compensation
|
Nonqualified
Deferred
Compensation
Earnings
|
All Other
Compensation
|
Total
|
|||||||||||||||||||||
Michael
T. Dent (2)
|
$ | 27,800 | $ | - | $ | 17,000 | $ | - | $ | - | $ | - | $ | 44,800 | ||||||||||||||
Steven
Jones (2)
|
26,600 | - | 17,000 | - | - | 199,600 | 243,200 | |||||||||||||||||||||
George
O'Leary (2)
|
30,350 | - | 17,000 | - | - | 60,200 | 107,550 | |||||||||||||||||||||
Peter
Peterson (2)
|
26,800 | - | 17,000 | - | - | - | 43,800 | |||||||||||||||||||||
William
Robison (3)
|
31,918 | - | 17,000 | - | - | - | 48,918 | |||||||||||||||||||||
Marvin
Jaffe (3)
|
26,100 | - | 17,000 | - | - | - | 43,100 |
(1)
|
On
June 6, 2007, upon the conclusion of the private placement and sale of
2.67 million shares of our stock at $1.50/share to disinterested third
parties, the board approved certain warrant compensation for each director
as an additional incentive to the nominal per meeting fees in
place. From the inception of the Company up until this time, no
stock-based compensation had ever been awarded to
directors. All warrants issued to directors had a strike price
equal to the private placement price per share ($1.50/share), a five year
term and a three year vesting period. For those directors who
had been a director for at least two years as of the date of the award,
25% of the warrants issued were deemed to have vested upon
issue. All of the remaining warrants were deemed to vest
ratably over a 36 month period. All of the warrants issued were
valued using the Black Scholes option/warrant valuation model with the
following assumptions: expected volatility – 35%, expected life
– 4 years, risk-free rate – 4.5%, and dividend yield – 0%. The
Company is expensing the value of these warrants over the vesting period
pursuant to the methodology outlined in SFAS 123(R). Pursuant
to Regulation SB, Item 402, Paragraph (f)(2)(iii), amounts indicated are
the amounts expensed for such warrants under SFAS 123 (R) for the year
ended December 31, 2008.
|
(2)
|
Awarded
on June 6, 2007 a warrant to purchase 100,000 shares of common stock as
board member compensation. Such warrants were valued at $51,000
using the Black-Scholes option/warrant valuation
model.
|
(3)
|
Awarded
on June 6, 2007 a warrant to purchase 75,000 shares of common stock as
board member compensation on June 6, 2007. Such warrants were
valued at $38,000 using the Black-Scholes option/warrant valuation
model.
|
(4)
|
Other
compensation for Mr. Jones reflects his consulting compensation for
serving as our Executive Vice President of Finance and Acting Principal
Financial Officer.
|
(5)
|
In
addition to Mr. O’Leary’s Board compensation warrants, Mr. O’Leary was
also awarded 100,000 warrants on March 15, 2007 in connection with certain
consulting services performed on behalf of the Company. Such
warrants have a strike price of $1.49/share and a five year
term. Half of such warrants were deemed vested up front and the
remaining half vest ratably over a 24 month period. Such
warrants had a value of $36,000 using the Black Scholes option/warrant
valuation model.
|
65
Employment
Agreements
Please
see Note G of the financial statements for disclosures with respect to the
employment agreements and offer letters, if applicable, to which certain of the
named executive officers described in the above Summary Compensation Table are
subject.
Securities
Authorized for Issuance Under Equity Compensation Plans (a)
Plan Category
|
Number of securities to
be issued upon exercise
of outstanding options,
warrants and rights
|
Weighted average
exercise price of
outstanding options,
warrants and rights
|
Number of securities
remaining available for
future issuance under
equity compensation
plans
|
|||||||||
Equity
compensation plans approved by security holders:
|
||||||||||||
Amended
and Restated Equity Incentive Plan (“Equity Incentive
Plan”)
|
4,861,653 | $ | 0.85 | 1,039,299 | (d) | |||||||
Employee
Stock Purchase Plan (“ESPP”)
|
- | N/A | 275,356 | |||||||||
Equity
compensation plans not approved by security holders
|
975,000 | (b,c) | $ | 0.96 | - | |||||||
Total
|
5,836,653 | $ | 0.87 |
(a)
|
As
of December 31, 2009.
|
(b)
|
Includes
an outstanding option to purchase 350,000 shares of common stock granted
to Robert P. Gasparini, our President and Chief Science Officer, outside
the Company’s Equity Incentive Plan on March 12, 2008. The
options have an exercise price of $0.80 per share and vests based on the
achievement of certain performance milestones. In the event of
a change of control of the Company, all unvested portions of the option
will vest in full. Unless sooner terminated pursuant to the
terms of the stock option agreement, the option will terminate on March
12, 2015.
|
(c)
|
Includes
outstanding warrants to purchase 625,000 shares of common stock at an
exercise price of $1.05 per share granted to Doug VanOort on March 16,
2009. The warrants vest based on the achievement of certain
performance milestones. In the event of a change of control of
the Company with a share price in excess of $4.00 per share, all unvested
warrants will vest immediately. Unless sooner terminated
pursuant to the terms of the warrant agreement, the warrants will
terminate on March 15, 2014.
|
(d)
|
The
Company’s Equity Incentive Plan was amended and restated on March 3, 2009,
and subsequently approved by shareholders holding a majority of the shares
outstanding, to allow for the issuance of an aggregate of up to 6,500,000
shares under the plan.
|
Currently,
the Company’s Equity Incentive Plan, as amended and restated on October 31, 2006
and again amended and restated on March 3, 2009, and the Company’s ESPP, dated
October 31, 2006, are the only equity compensation plans in
effect.
66
PRINCIPAL
STOCKHOLDERS
The
following table sets forth information as of April 27, 2010, with respect to
each person known by the Company to own beneficially more than 5% of the
Company’s outstanding common stock, each director and officer of the Company and
all directors and executive officers of the Company as a group. The
Company has no other class of equity securities outstanding other than common
stock.
67
Title of
Class
|
Name And Address Of Beneficial Owner
|
Amount and Nature
Of Beneficial
Ownership (1)
|
Percent Of Class(1)
|
|||||||
Common
|
Aspen
Select Healthcare, LP (2)
1740
Persimmon Drive, Suite 100
Naples,
Florida 34109
|
11,666,155 | 28.9 | % | ||||||
Common
|
Steven
C. Jones (3)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
12,786,362 | 31.4 | % | ||||||
Common
|
Michael
T. Dent, M.D. (4)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
2,489,162 | 6.6 | % | ||||||
Common
|
Douglas
M. VanOort (5)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
1,199,000 | 3.2 | % | ||||||
Common
|
Robert
P. Gasparini (6)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
1,186,275 | 3.1 | % | ||||||
Common
|
George
O’Leary (7)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
200,000 | * | |||||||
Common
|
Peter
M. Peterson (8)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
11,978,900 | 29.6 | % | ||||||
Common
|
William
J. Robison (9)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
144,713 | * | |||||||
Common
|
Marvin
E. Jaffe, M.D. (10)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
96,429 | * | |||||||
Common
|
George
Cardoza (11)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
9,000 | * | |||||||
Common
|
Grant Carlson
(12)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
24,850 | * | |||||||
Common
|
Matthew
W. Moore (13)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
76,875 | * |
68
Common
|
Jack
G. Spitz
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
- | * | |||||||
Common
|
Jerome
J. Dvonch (14)
c/o
NeoGenomics, Inc.
12701
Commonwealth Blvd, Suite 5
Fort
Myers, FL 33193
|
165,167 | - | |||||||
Common
|
Directors
and Officers as a Group (13 persons) (15)
|
18,477,833 | 42.3 | % | ||||||
Common
|
Abbott
Laboratories (16)
100
Abbott Park Road
Dept.
322, Bldg. AP6A-2
Abbott
Park, Illinois 60064-6049
|
3,500,000 | 9.4 | % | ||||||
Common
|
SKL
Family Limited Partnership (17)
984
Oyster Court
Sanibel,
FL 33957
|
2,900,000 | 7.6 | % | ||||||
Common
|
1837
Partners, LP., 1837 Partners, QP,LP., and
1837
Partner Ltd. (1837 RMB Managers, LLC) (18)
115
South LaSalle St., 34th
Floor
Chicago,
IL 60603
|
3,481,175 | 9.3 | % | ||||||
Common
|
Blair
R. Haarlow (19)
c/o
RMB Capital
115
South LaSalle St., 34th
Floor
Chicago,
IL 60603
|
3,927,585 | 10.5 | % | ||||||
Common
|
Francis
Tuite (20)
c/o
RMB Capital
115
South LaSalle St., 34th Floor
Chicago,
IL 60603
|
3,524,175 | 9.5 | % |
* Less
than one percent (1%)
(1)
|
The
number and percentage of shares beneficially owned are determined in
accordance with Rule 13d-3 of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”),
and the information is not necessarily indicative of beneficial ownership
for any other purpose. Under such rule, beneficial ownership
includes any shares over which the individual or entity has voting power
or investment power and any shares of common stock that the individual has
the right to acquire within 60 days of April 27, 2010, through the
exercise of any stock option or other right. As of April 27,
2010, 37,278,667 shares of the Company’s common stock were
outstanding.
|
(2)
|
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.
|
(3)
|
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 Aspen shares and currently
exercisable warrants have been added to his total (see Note
2).
|
69
(4)
|
Michael
T. Dent, M.D. is a director of the Company. Dr. Dent’s
beneficial ownership includes (i) 900,000 shares held in the Mary S. Dent
Gifting Trust (of which Dr. Dent and his attorney are the sole trustees),
(ii) warrants and options exercisable within sixty days of April 27, 2010
to purchase 572,992 shares, and (iii) 1,016,170 shares owned directly by
Dr. Dent’s spouse, Mary S. Dent.
|
(5)
|
Douglas
M. VanOort, the Chairman and CEO of the Company, has direct ownership of
(i) 636,500 shares, (ii) warrants exercisable within 60 days of
April 27, 2010 to purchase 125,000 shares of stock, and (iii) options
exercisable within sixty days of April 27, 2010 to purchase 437,500
shares.
|
(6)
|
Robert
P. Gasparini, President of the Company, has direct ownership of 145,275
shares and options exercisable within 60 days of April 27, 2010 to
purchase 1,041,000 shares.
|
(7)
|
George
O’Leary, a director of the Company, has direct ownership of warrants
exercisable within 60 days of April 27, 2010 to purchase 200,000
shares.
|
(8)
|
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 2). 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.
|
(9)
|
William
J. Robison, a director of the Company, has direct ownership of 69,713
shares and warrants exercisable within 60 days of April 27, 2010 to
purchase 75,000 shares.
|
(10)
|
Marvin
E. Jaffe, M.D., a director of the Company, has direct ownership of 21,429
shares and warrants exercisable within 60 days of April 27, 2010 to
purchase 75,000 shares.
|
(11)
|
George
Cardoza, Chief Financial Officer, has direct ownership of 9,000
shares.
|
(12)
|
Grant
Carlson, Vice President of Sales and Marketing, has direct ownership of
6,100 shares and options exercisable within 60 days of April 27, 2010 to
purchase 18,750 shares.
|
(13)
|
Matthew
W. Moore, Vice President of Research and Development, has options
exercisable within 60 days of April 27, 2010 to purchase 76,875
shares.
|
(14)
|
Jerome
J. Dvonch, Principal Accounting Officer, has options exercisable within 60
days of April 27, 2010 to purchase 165,167
shares.
|
(15)
|
The
total number of shares listed does not double count the shares that may be
beneficially attributable to more than one
person.
|
(16)
|
Abbott
Laboratories has direct ownership of 3,500,000
share.
|
(17)
|
SKL
Family Limited Partnership has direct ownership of 2,000,000 shares and
warrants exercisable within 60 days of April 27, 2010 to purchase 900,000
shares. The general partners of the SKL Family Limited
Partnership are the Kent Logan Irrevocable Trust u/t/d 2/6/2008 and the
Lance Logan Irrevocable Trust u/t/d 2/6/2008, with Kent Logan and Lance
Logan as co-trustees of each trust.
|
(18)
|
1837
RMB Managers, LLC and its affiliates have direct ownership of 3,481,175
shares. 1837 RMB Managers, LLC acts as the general partner and
makes all the investment decisions for 1837 Partners LP., 1837 Partners
QP, LP and 1837 Partners LTD who own the shares
listed.
|
(19)
|
Blair
R. Haarlow has direct ownership of 80,500 shares and controls certain
trusts which own 365,910 shares. In addition, as a managing
member of 1837 RMB Managers, LLC, he has the right to vote all shares
controlled by 1837 RMB Managers, thus all shares owned or controlled by
1837 RMB Managers, LLC have been added to his total (see Note
18).
|
(20)
|
Frances
E. Tuite has direct ownership of 43,000 shares. In addition, as
a managing member of 1837 RMB Managers, LLC, she has the right to vote all
shares controlled by 1837 RMB Managers, thus all shares owned or
controlled by 1837 RMB Managers, LLC have been added to her total (see
Note 18).
|
70
MARKET
PRICE OF AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY AND OTHER STOCKHOLDER
MATTERS
Our
common stock is quoted on the OTC Bulletin Board under the symbol
“NGNM”. Set forth below is a table summarizing the high and low bid
quotations for our common stock during the last two fiscal years.
HIGH BID
|
LOW BID
|
|||||||
1st
Quarter 2010
|
$ | 1.70 | $ | 1.15 | ||||
4th
Quarter 2009
|
$ | 1.80 | $ | 1.41 | ||||
3rd
Quarter 2009
|
$ | 2.25 | $ | 1.32 | ||||
2nd
Quarter 2009
|
$ | 1.49 | $ | 0.92 | ||||
1st
Quarter 2009
|
$ | 1.19 | $ | 0.56 | ||||
4th
Quarter 2008
|
$ | 1.05 | $ | 0.56 | ||||
3rd
Quarter 2008
|
$ | 1.15 | $ | 0.83 | ||||
2nd
Quarter 2008
|
$ | 1.35 | $ | 0.86 | ||||
1st
Quarter 2008
|
$ | 1.15 | $ | 0.72 |
The above
table is based on over-the-counter quotations. These quotations reflect
inter-dealer prices, without retail mark-up, markdown or commissions, and may
not necessarily represent actual transactions. All historical data
was obtained from the www.NASDAQ.com web site. As of April 27, 2010,
the last reported price of our common was $1.42 per share.
As of
April 27, 2010, there were 503 stockholders of record of our common stock,
excluding stockholders who hold their shares in brokerage accounts in “street
name”. Of the 37,278,667 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.
Dividend
Policy
We have
never declared or paid cash dividends on our common stock. We intend to retain
all future earnings to finance future growth and therefore, do not anticipate
paying any cash dividends in the foreseeable future. In addition,
certain financing agreements entered into by the Company may limit our ability
to pay dividends in the future.
71
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Consulting
Agreements
During
2009, 2008 and 2007, Steven C. Jones, a director of the Company and Executive
Vice President of Finance, earned $199,600, $176,300 and $128,000, respectively,
for various consulting work performed in connection with his duties as Executive
Vice President of Finance and 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, 2008 and 2007, George O’Leary, a director of the Company, earned $60,200,
$22,200 and $9,500, respectively, in cash for various consulting work performed
for the Company. On May 13, 2005, Mr. O’Leary received 100,000
warrants to purchase common stock in connection with consulting work performed
for the Company. Such warrants had an exercise price of $0.25 per
share and a five year term. 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. 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 issued in May 2005 and the 50,000 stock
options issued in January 2006 in a cash-less exercise per the terms of the
agreements. The Company issued 85,030 and 42,215 shares to settle
these exercises, respectively.
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.
On June
6, 2007, we issued to the six non-employee director’s of our board of directors
a total of 550,000 warrants. Such warrants had an exercise price of
$1.50/share with three year vesting and a five year final term. These
warrants were valued at approximately $280,000 on the date of issuance using the
Black-Scholes option pricing model and our being expensed over the vesting
period. These warrants expire in June 2012.
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, 2008 and 2007, HCSS earned approximately $87,675, $99,900 and
approximately $77,000, 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.
72
Gulf Pointe Capital Lease
Agreement
On
September 30, 2008, we entered into a master lease agreement (the “Master
Lease”) with Gulf Pointe Capital, LLC (“Gulf Pointe”) which provided for
$130,000 of lease financing after it was determined that the lease facility with
Leasing Technologies International, Inc. would not allow for the leasing of
certain used and other types of equipment. Three members
of our Board of Directors, Steven Jones, Peter Petersen and Marvin Jaffe, are
affiliated with Gulf Pointe and recused themselves from both sides of all
negotiations concerning this transaction. The terms under this lease
are consistent with the terms of our other lease arrangements and provided for
the sale/leaseback of approximately $130,000 of used laboratory equipment. The
lease has a 30 month term and a lease rate factor of 0.0397/month, which equates
to monthly payments of $5,155 during the term. In consideration for entering
into the Master Lease, the Company issued 32,475 common stock warrants to Gulf
Pointe with an exercise price of $1.08 and a five year term. The
warrants were valued at approximately $11,000 using the Black-Scholes option
pricing model. At the end of the lease term, the Company’s options are as
follows: (a) purchase not less than all of the equipment for its then
fair market value, not to exceed 15% of the original equipment cost, (b) extend
the lease term for a minimum of six months, or (c) return not less than all the
equipment at the conclusion of the lease term.
On
February 9, 2009, we amended our Master Lease with GulfPointe to increase the
maximum size of the facility to $250,000 and entered into a second schedule
under the Master Lease for the sale/leaseback of approximately $118,000 of used
laboratory equipment. This second lease has a 30 month term at the same lease
rate factor per month as the first lease, which equates to monthly payments of
$4,690 during the term. As part of this amendment, we terminated the original
warrant agreement dated September 30, 2008 and replaced it with a new warrant to
purchase 83,333 shares of our common stock. Such new warrants have a
five year term, an exercise price of $0.75 per share and the same vesting
schedule as the original warrants. The replacement warrants were valued using
the Black-Scholes option pricing model and the value did not materially differ
from the valuation of the original warrants they replaced.
Share Purchase by the
Douglas M. VanOort Living Trust
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”). Douglas M VanOort is Chairman of the Company Board
of Directors and Executive Chairman and interim Chief Executive Officer of the
Company. 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”). These warrants had an aggregate fair value of
$160,267. 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.
73
Common
Stock
We are
authorized to issue 100,000,000 shares of common stock, par value $0.001 per
share, of which 37,278,667 shares were issued and outstanding as
of April 27, 2010.
The
securities being offered hereby are common stock. The outstanding shares of our
common stock are fully paid and non-assessable. The holders of common stock are
entitled to one vote per share for the election of directors and with respect to
all other matters submitted to a vote of stockholders. Shares of our common
stock do not have cumulative voting rights, which means that the holders of more
than 50% of such shares voting for the election of directors can elect 100% of
the directors if they choose to do so. Our common stock does not have preemptive
rights, meaning that the common stockholders’ ownership interest in the Company
would be diluted if additional shares of common stock are subsequently issued
and the existing stockholders are not granted the right, at the discretion of
the Board of Directors, to maintain their ownership interest in our
Company.
Upon liquidation,
dissolution or winding-up of the Company, our assets, after the payment of debts
and liabilities and any liquidation preferences of, and unpaid dividends on, any
class of preferred stock then outstanding, will be distributed pro-rata to the
holders of our common stock. The holders of our common stock do not have
preemptive or conversion rights to subscribe for any of our securities and have
no right to require us to redeem or purchase their shares. The
holders of common stock are entitled to share equally in dividends, if, as and
when declared by our Board of Directors, out of funds legally available
therefore, subject to the priorities given to any class of preferred stock which
may be issued.
Preferred
Stock
We are
authorized to issue 10,000,000 shares of preferred stock, par value $0.001 per
share (the “Preferred
Stock”). Preferred Stock may be issued from time to time in
one or more series. The Board of Directors is authorized to fix or alter the
dividend rights, dividend rate, conversion rights, voting rights, rights and
terms of redemption (including sinking fund provisions), the redemption
price or prices, the liquidation preferences of any wholly unissued series of
Preferred Stock, and the number of shares constituting any such series and the
designation thereof, or any of them; and to increase or decrease the number of
shares of any series subsequent to the issue of shares of that series, but not
below the number of shares of such series then outstanding and which the Company
may be obligated to issue under options, warrants or other contractual
commitments. In case the number of shares of any series shall be so decreased,
the shares constituting such decrease shall resume the status which they had
prior to the adoption of the resolution originally fixing the number of shares
of such series. As of April 27, 2010, no such shares had been
designated.
Warrants
As of
April 27, 2010, warrants to purchase 5,891,750 shares of our common
stock were outstanding, 5,391,750 of which were
vested. The exercise prices of these warrants range from $0.26 to
$1.50 per share.
Options
As of
April 27, 2010, options to purchase 5,017,336 shares of our common stock were
outstanding. The exercise prices of these options range from $0.16 to
$1.82 per share.
Transfer
Agent
The
Company’s transfer agent is Standard Registrar & Transfer Company located at
12528 South 1840 East Draper, Utah, 84020. The
transfer agent’s telephone number is (801) 571-8844.
Reports
To Stockholders
We file
an annual report on Form 10-K with the Securities Exchange Commission each year
which describes the nature and scope of our business and operations for the
prior year and contains a copy of our audited financial statements for the most
recent fiscal year.
74
Indemnification
Of Directors And Executive Officers And Limitation On Liability
The
Company’s Articles of Incorporation provide that no director or officer of the
Company shall be personally liable to the Company or any of its stockholders for
damages for breach of fiduciary duty as a director or officer of for any act or
omission of any such director or officer; however such indemnification shall not
eliminate or limit the liability of a director or officer for (a) acts or
omissions which involve intentional misconduct, fraud or a knowing violation of
law or (b) the payment of dividends in violation of Section 78.300 of the Nevada
Revised Statutes. The Company’s Amended and Restated Bylaws (the “Bylaws”) provide that
any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative, by reason of the fact that such
person is or was a director, officer, employee or agent of the Company (or is or
was serving at the request of the Company as a director, officer, employee or
agent of another corporation, partnership, joint venture, trust or other
enterprise) shall be indemnified and held harmless by the Company to the fullest
extent permitted by Nevada law against expenses including attorneys’ fees,
judgments, fines and amounts paid in settlement actually and reasonably incurred
by such person in connection with such proceeding.
The
Bylaws also provide that the Company must indemnify any person who was or is a
party, or is threatened to be made a party, to any threatened, pending or
completed proceeding by or in the right of the Company to procure a judgment in
its favor by reason of the fact that such person is or was a director, officer,
employee or agent of the Company, or is or was serving at the request of the
Company as a director, officer, employee, or agent of another corporation,
partnership, joint venture, trust or other enterprise against costs incurred by
such person in connection with the defense or settlement of such action or suit.
Such indemnification may not be made for any claim, issue or matter as to which
such person has been adjudged by a court of competent jurisdiction, after
exhaustion of all appeals, to be liable to the Company or for amounts paid in
settlement to the Company, unless and only to the extent that the court
determines upon application that in view of all the circumstances of the case,
the person is fairly and reasonably entitled to indemnity for such expenses as
the court deems proper.
The
Bylaws provide that the Company must pay the costs incurred by any person
entitled to indemnification in defending a proceeding as such costs are incurred
and in advance of the final disposition of a proceeding; provided however, that
the Company must pay such costs only upon receipt of an undertaking by or on
behalf of such person to repay the amount if it is ultimately determined by a
court of competent jurisdiction that such person is not entitled to be
indemnified by the Company.
The
Bylaws provide that the Company may purchase and maintain insurance or make
other financial arrangements on behalf of any person who is or was a director,
officer, employee or agent of the Company, or is or was serving at the request
of the Company as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise in accordance with Section
78.752 of the Nevada Revised Statutes.
Nevada
Revised Statutes 78.751 and 78.7502 have similar provisions that provide for
discretionary and mandatory indemnification of officers, directors, employees,
and agents of a corporation. Under these provisions, such persons may be
indemnified by a corporation against expenses, including attorney’s fees,
judgment, fines and amounts paid in settlement, actually and reasonably incurred
by him in connection with the action, suit or proceeding, if he acted in good
faith and in a manner which he reasonably believed to be in or not opposed to
the best interests of the corporation and with respect to any criminal action or
proceeding had no reasonable cause to believe his conduct was
unlawful.
To the
extent that a director, officer, employee or agent has been successful on the
merits or otherwise in defense of any action, suit or proceeding, or in defense
of any claim, issue or matter, the Nevada Revised Statues provide that he must
be indemnified by the Company against expenses, including attorney’s fees,
actually and reasonably incurred by him in connection with the
defense.
Section
78.751 of the Nevada Revised Statues also provides that any discretionary
indemnification, unless ordered by a court or advanced by the Company, must be
made only as authorized in the specific case upon a determination that
indemnification of the director, officer, employee or agent is proper in the
circumstances. The determination must be made:
|
·
|
By
the stockholders;
|
|
·
|
By
the Company’s Board of Directors by majority vote of a quorum consisting
of directors who were not parties to that act, suit or
proceeding;
|
|
·
|
If
a majority vote of a quorum consisting of directors who were not parties
to the act, suit or proceeding cannot be obtained, by independent legal
counsel in a written opinion;
or
|
75
|
·
|
If
a quorum consisting of directors who were not parties to the act, suit or
proceeding cannot be obtained, by independent legal counsel in a written
opinion.
|
Insofar
as indemnification for liabilities arising under the Securities Act, as amended,
may be permitted to directors, officers, and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or
paid by a director, officer, or controlling person in the successful defense of
any action, suit, or proceeding) is asserted by such director, officer, or
controlling person connected with the securities being registered, we will,
unless in the opinion of our counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such
issue.
76
LEGAL
MATTERS
The
validity of the shares offered hereby has been opined on for us by Burton,
Bartlett & Glogovac.
Our
consolidated financial statements as of December 31, 2009 and 2008 and for
the years then ended included or referred to in this prospectus have been
audited by Kingery & Crouse, P.A., independent registered public
accountants, and are included in this prospectus in reliance on this firm as
experts in accounting and auditing.
AVAILABLE
INFORMATION
We have
filed with the SEC a registration statement on Form S-1 under the Securities Act
with respect to the securities offered by this prospectus. This prospectus,
which forms a part of the registration statement, does not contain all the
information set forth in the registration statement, as permitted by the rules
and regulations of the SEC. For further information with respect to us and the
securities offered by this prospectus, reference is made to the registration
statement.
Statements
contained in this prospectus as to the contents of any contract or other
document that we have filed as an exhibit to the registration statement are
qualified in their entirety by reference to the exhibits for a complete
statement of their terms and conditions.
We file
annual, quarterly and current reports and other information with the
SEC. Such reports, the registration statement and other information
may be read and copied at the SEC’s Public Reference Room at 100 F Street, N.E.,
Washington, D.C. 20549 on official business days during the hours of 10 a.m. to
3 p.m. The public may obtain information on the operation of the
Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC
maintains a web site at http://www.sec.gov
that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC.
77
|
PAGE
|
|
CONSOLIDATED
FINANCIAL STATEMENTS - MARCH 31, 2010
|
||
Condensed
Consolidated Balance Sheets for the Periods Ended March 31, 2010 and
December 31, 2009
|
F-1
|
|
Condensed
Consolidated Statements of Operations for the Three Months Ended March 31,
2010 and 2009
|
F-2
|
|
Condensed
Consolidated Statements of Cash Flows for the Three Months Ended March 31,
2010 and 2009
|
F-3
|
|
Notes
to Condensed Consolidated Financial Statements
|
F-4
|
|
PAGE
|
CONSOLIDATED
FINANCIAL STATEMENTS—DECEMBER 31, 2009 and 2008
|
|
Report
of Independent Registered Public Accounting Firm
|
F-10
|
Consolidated
Balance Sheets as of December 31, 2009 and 2008
|
F-11
|
Consolidated
Statements of Operations for the Years Ended December 31, 2009 and
2008
|
F-12
|
Consolidated
Statements of Stockholders’ Equity for the Years Ended December 31, 2009
and 2008
|
F-13
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2009 and
2008
|
F-14
|
Notes
to Consolidated Financial Statements as of and for the years ended
December 31, 2009 and 2008
|
F-15
|
F-i
NEOGENOMICS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share data)
|
March 31, 2010
|
December 31, 2009
|
||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
CURRENT
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 AND STOCKHOLDERS’
EQUITY
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
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, $.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 |
See
notes to unaudited condensed consolidated financial statements.
F-1
NEOGENOMICS,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands, except per share amounts)
(unaudited)
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 | |||||
INTEREST
INCOME (EXPENSE) - NET
|
(159 | ) | (115 | ) | ||||
NET
INCOME (LOSS)
|
$ | (750 | ) | $ | 33 | |||
NET
INCOME (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 |
See notes
to unaudited condensed consolidated financial statements.
F-2
NEOGENOMICS,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands)
(unaudited)
For the Three Months Ended
March 31,
|
||||||||
2010
|
2009
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
income (loss)
|
$ | (750 | ) | $ | 33 | |||
Adjustments
to reconcile net income (loss) to net cash used in provided by operating
activities:
|
||||||||
Provision
for bad debts
|
540 | 508 | ||||||
Depreciation
|
415 | 237 | ||||||
Amortization
of debt issue costs
|
18 | 13 | ||||||
Stock-based
compensation
|
109 | 58 | ||||||
Non-cash
consulting expenses
|
19 | 20 | ||||||
Changes
in assets and liabilities, net:
|
||||||||
(Increase)
decrease in accounts receivable, net of write-offs
|
(1,401 | ) | (1,550 | ) | ||||
(Increase)
decrease in inventories
|
20 | (86 | ) | |||||
(Increase)
decrease in prepaid expenses
|
122 | (28 | ) | |||||
(Increase)
decrease in deposits
|
- | (8 | ) | |||||
Increase
(decrease) in accounts payable and other liabilities
|
(656 | ) | 472 | |||||
NET
CASH USED IN OPERATING ACTIVITIES
|
(1,564 | ) | (331 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Purchases
of property and equipment
|
(114 | ) | (6 | ) | ||||
NET
CASH USED IN INVESTING ACTIVITIES
|
(114 | ) | (6 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Proceeds
from capital lease obligations
|
25 | 97 | ||||||
Advances
on credit facility
|
1,901 | 272 | ||||||
Repayment
of capital leases
|
(300 | ) | (138 | ) | ||||
Issuance
of common stock and warrants for cash, net of transaction
expenses
|
82 | 495 | ||||||
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
1,708 | 726 | ||||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
30 | 389 | ||||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
1,631 | 468 | ||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 1,661 | $ | 857 | ||||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION
|
||||||||
Interest
paid
|
$ | 144 | $ | 100 | ||||
Income
taxes paid
|
$ | — | $ | — | ||||
NON-CASH
INVESTING AND FINANCING ACTIVITIES
|
||||||||
Equipment
leased under capital leases
|
$ | 746 | $ | 179 | ||||
Equipment
purchased and payables settled with issuance of restricted common
stock
|
$ | - | $ | 186 |
See notes
to unaudited condensed consolidated financial statements.
F-3
NEOGENOMICS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2010
NOTE A — NATURE OF BUSINESS AND BASIS
OF FINANCIAL STATEMENT PRESENTATION
Nature of
Business
NeoGenomics,
Inc., a Nevada corporation (the “Parent”), and its subsidiary, NeoGenomics
Laboratories, Inc. (formerly known as NeoGenomics, Inc.), a Florida corporation
(“NEO”, “NeoGenomics Laboratories” or the “Subsidiary”) (collectively referred
to as “we”, “us”, “our”, “NeoGenomics”, or the “Company”), operates as a
certified “high complexity” clinical laboratory in accordance with the federal
government’s Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), and is
dedicated to the delivery of clinical diagnostic services to pathologists,
oncologists, urologists, hospitals, and other laboratories throughout the United
States.
Basis of
Presentation
The
accompanying condensed consolidated financial statements include the accounts of
the Parent and the Subsidiary. All significant intercompany accounts and
balances have been eliminated in consolidation.
The
accompanying condensed consolidated financial statements of the Company are
unaudited and include all adjustments, in the opinion of management, which are
necessary to make the financial statements not misleading. Except as otherwise
disclosed, all such adjustments are of a normal recurring nature. Interim
results are not necessarily indicative of results for a full year.
The
interim condensed consolidated financial statements and notes are presented in
accordance with the rules and regulations of the Securities and Exchange
Commission and do not contain certain information included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2009. Therefore, the
interim condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements and notes thereto
contained in the Company’s annual report.
Use of
Estimates
The
preparation of condensed consolidated financial statements in conformity with
GAAP requires management to make estimates and assumptions that affect the
amounts reported in the condensed consolidated financial statements and these
notes to the condensed consolidated financial statements. The most significant
estimates in the Company’s condensed consolidated financial statements relate to
revenue recognition, allowance for doubtful accounts and stock-based
compensation. Actual results could differ from those estimates.
Revenue
Recognition
The
Company recognizes revenues in accordance with the Securities and Exchange
Commission’s (the “Commission”) Staff Accounting Bulletin Topic 13.A.1 (ASC
605-10-S99-1)No. 104, “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.
F-4
NEOGENOMICS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2010
Accounts Receivable and
Allowance for Doubtful Accounts
Accounts
receivable are reported at realizable value, net of allowance for doubtful
accounts (the “Allowance”), which is estimated and recorded in the period the
related revenue is recorded based on the historical collection experience for
each type of payor. In addition, the Allowance is adjusted
periodically, based upon an evaluation of historical collection experience with
specific payors, payor types, and other relevant factors, including regularly
assessing the state of our billing operations in order to identify issues which
may impact the collectability of receivables or reserve
estimates. Revisions to the Allowance are recorded as an adjustment
to bad debt expense within general and administrative expenses. After
appropriate collection efforts have been exhausted, specific receivables deemed
to be uncollectible are charged against the Allowance in the period they are
deemed uncollectible. Recoveries of receivables previously
written-off are recorded as credits to the Allowance.
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with FASB ASC Topic
718 Compensation – Stock Compensation. ASC 718 requires recognizing
compensation costs for all share-based payment awards made to employees and
directors based upon the awards’ grant-date fair value. The standard
covers employee stock options, restricted stock, and other equity
awards.
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’ vesting periods. The
Company estimates an expected forfeiture rate, which is factored into the
determination of the Company’s periodic expense.
Net Income (Loss) Per Common
Share
We
compute net income (loss) per share in accordance with ASC 260, Earnings per
Share (“ASC 260”). Under the provisions of ASC 260, basic net income (loss) per
share is computed by dividing the net income (loss) available to common
stockholders by the weighted average number of common shares outstanding during
the period. Diluted net income (loss) per share is computed by dividing the net
income (loss) for the period by the weighted average number of common and common
equivalent shares outstanding, using the treasury stock method, during the
period. Equivalent shares consist of employee stock options and certain warrants
issued to consultants and other providers of financing to the Company that are
in-the-money based on the weighted average closing share price for the period.
Under the treasury stock method, the number of in-the-money shares that are
considered outstanding for this calculation is reduced by the number of common
shares that theoretically could have been re-purchased by the Company with the
aggregate exercise proceeds of such warrant and option exercises if such shares
were re-purchased at the average market price for the period.
There
were no common equivalent shares included in the calculation of diluted earnings
per share for the three month period ended March 31, 2010 because the Company
had a net loss for such period and therefore such common equivalent shares were
anti-dilutive. Common equivalent shares outstanding as of March 31, 2009 using
the treasury stock method includes approximately 2.63 million equivalent shares
for unexercised warrants and approximately 827,000 shares for unexercised stock
options, and these were included in the earnings per share calculation for the
three months ended March 31, 2009.
F-5
NEOGENOMICS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2010
NOTE B — REVOLVING CREDIT AND
SECURITY AGREEMENT
On
February 1, 2008, our subsidiary, NeoGenomics Laboratories, Inc., a Florida
corporation (“Borrower”), entered into a Revolving Credit and Security Agreement
(the “Credit Facility” or “Credit Agreement”) with CapitalSource, the terms of
which provide for borrowings based on eligible accounts receivable up to a
maximum borrowing of $3.0 million, as defined in the Credit Agreement. Subject
to the provisions of the Credit Agreement, CapitalSource shall make advances to
us from time to time during the three year term, and the Credit Facility may be
drawn, repaid and redrawn from time to time as permitted under the Credit
Agreement.
Interest
on outstanding advances under the Credit Facility are payable monthly in arrears
on the first day of each calendar month at an annual rate based on the one-month
LIBOR plus 3.25%, subject to a LIBOR floor of 3.14%. At March 31, 2010, the
effective rate of interest was 6.39%.
To secure
the payment and performance in full of the Obligations (as defined in the Credit
Agreement), we granted CapitalSource a continuing security interest in and lien
upon, all of our rights, title and interest in and to our Accounts (as defined
in the Credit Agreement), which primarily consist of accounts receivable and
cash balances held in lock box accounts. Furthermore, pursuant to the Credit
Agreement, the Parent guaranteed the punctual payment when due, whether at
stated maturity, by acceleration or otherwise, of all of the Obligations. The
Parent guaranty is a continuing guarantee and shall remain in force and effect
until the indefeasible cash payment in full of the Guaranteed Obligations (as
defined in the Credit Agreement) and all other amounts payable under the Credit
Agreement are made.
On
November 3, 2008, the Company and CapitalSource signed a first amendment to the
Credit Agreement. This amendment increased the amount allowable under the Credit
Agreement to pay towards the settlement of the US Labs lawsuit to $250,000 from
$100,000 and documented other administrative agreements between NeoGenomics and
CapitalSource.
On April
14, 2009, the Parent Company, NeoGenomics Laboratories, Inc. (the wholly owned
subsidiary of the Parent Company) (“Borrower”) and CapitalSource (as agent for
CapitalSource Bank) entered into a Second Amendment to Revolving Credit and
Security Agreement (the “Second Amendment”). The Second Amendment, among other
things, amends that certain Revolving Credit and Security Agreement dated
February 1, 2008 as amended by that certain First Amendment to Revolving Credit
and Security Agreement dated November 3, 2008 (as amended, the “Loan Agreement”)
to (i) provide that through December 31, 2009, the Borrower must maintain
Minimum Liquidity (as defined in the Loan Agreement) of not less than $500,000,
(ii) amend the definitions of “Fixed Charge Coverage Ratio” and “Fixed Charges”,
(iii) amend the definition of “Permitted Indebtedness” to increase the amount of
permitted capitalized lease obligations and indebtedness incurred to purchase
goods secured by certain purchase money liens and (iv) amend and update certain
representations, warranties and schedules. In addition, pursuant to the Second
Amendment, CapitalSource waived the following events of default under the Loan
Agreement: (i) the failure of the Borrower to comply with the fixed charge
coverage ratio covenant for the test period ending December 31, 2008, (ii) the
failure of the Borrower to notify CapitalSource of the change of Borrower’s name
to NeoGenomics Laboratories, Inc. and to obtain CapitalSource’s prior consent to
the related amendment to Borrower’s Articles of Incorporation, (iii) the failure
of the Parent Company and the Borrower to obtain CapitalSource’s prior written
consent to the amendment of the Parent Company’s bylaws to allow for the size of
the Parent Company’s Board of Directors to be increased to eight members and
(iv) the failure of the Borrower to notify CapitalSource of the filing of an
immaterial complaint by the Borrower against a former employee of the Borrower.
The Company paid CapitalSource Bank a $25,000 amendment fee in connection with
the Second Amendment.
On March
26, 2010, we entered into an amendment (the “Third Amendment”) to the credit
facility agreement with CapitalSource for which we paid CapitalSource an
amendment fee of $25,000 which was creditable against the commitment fee for our
amended and restated Credit Agreeement signed on April 26, 2010. The
Third Amendment waived events of default relating to our failure to comply with
the Fixed Charge Coverage Ratio for the Test Periods ended January 31, 2010 and
February 28, 2010. The Third Amendment also revised the Fixed Charge Coverage
Ratio calculation for the Test Period ending March 31, 2010 to permit us to add
amounts of unrestricted cash, unrestricted cash equivalents and unused
availability to Adjusted EBITDA for purposes of the test. For each monthly Test
Period after March 31, 2010, the calculation of the Fixed Charge Coverage Ratio
will revert to Adjusted EBITDA, without adjustment for such
amounts. We were in compliance with our covenants for the period
ended March 31, 2010.
On March
31, 2010, we had an outstanding amount due on the Credit Facility of
approximately $2,450,000 and the available credit under the Credit Facility was
approximately $550,000.
F-6
NEOGENOMICS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2010
On April
26, 2010 as described more fully in Note F 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.
NOTE C — COMMON STOCK PURCHASE
AGREEMENT
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.
In consideration for entering into this Stock Agreement, on October 10, 2008, we
issued to Fusion 17,500 shares of our common stock (valued at $14,700 on the
date of issuance) and paid $17,500 as a due diligence expense reimbursement. In
addition, on November 5, 2008, we issued to Fusion 400,000 shares of our common
stock (valued at $288,000 on the date of issuance) as a commitment fee.
Concurrently with entering into the Stock Agreement, we entered into a
registration rights agreement with Fusion. Under the registration rights
agreement, we agreed to file a registration statement with the SEC covering the
417,500 shares that have already been issued to Fusion and at least 3.0 million
shares that may be issued to Fusion under the Stock Agreement. Presently, we
expect to sell no more than the initial 3.0 million shares to Fusion during the
term of this Stock Agreement. The Company filed a registration statement on Form
S-1 on November 28, 2008 and on February 5, 2009 the registration statement
became effective and on April 28, 2009, we filed Post Effective Amendment No 1
to the registration statement which became effective on May 8,
2009.
Under the
Stock Agreement we have the right to sell to Fusion shares of our common stock
from time to time in amounts between $50,000 and $1.0 million, depending on the
market price of our common stock. The purchase price of the shares related to
any future funding under the Stock Agreement will be based on the prevailing
market prices of our stock at the time of such sales without any fixed discount,
and the Company will control the timing and amount of any sales of shares to
Fusion. Fusion shall not have the right or 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 per share. The Stock Agreement may be terminated by us at any time
at our discretion without any cost to us. There are no negative covenants,
restrictions on future funding from other sources, penalties, further fees or
liquidated damages in the agreement.
Given our
current liquidity position from cash on hand and our availability under our
Credit Facility with CapitalSource, we have no immediate plans to issue common
stock under the Stock Agreement. If and when we do elect to sell shares to
Fusion under this agreement, we expect to do so opportunistically and only under
conditions deemed favorable by the Company. Any proceeds received by the Company
from sales under the Stock Agreement will be used for general corporate
purposes, working capital, and/or for expansion activities.
NOTE
D — CAPITAL LEASE TRANSACTIONS
Wells Fargo Lease
Agreement
On
January 14, 2010, we entered into Lease Supplement No. 2 for $424,000 which was
used to acquire laboratory equipment. Supplement No. 2, which was accounted for
as a capital lease, has a term of 60 months with monthly payments of $8,628 and
a $1 final purchase payment at termination.
After
entering into Supplement No. 2 on January 14, 2010, we have approximately
$61,000 available for further advances under the Wells Fargo Lease.
SunTrust Lease
Agreement
On
January 19, 2010, we entered into Lease Schedule No. 2 for $290,000 which was
used to fund laboratory equipment and furniture and fixtures. Schedule 2, which
was accounted for as a capital lease, has a term of 60 months with monthly
payments of $5,704 and a $1 final purchase payment at termination.
NOTE E — RELATED PARTY
TRANSACTIONS
Consulting
Agreements
F-7
NEOGENOMICS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2010
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
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 May 2010. This agreement has an initial term of
five years from the date of acceptance and calls for monthly fees of
$8,000-$12,000 during the term.
During
2010, 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, eTelenext/HCSS earned approximately
$69,000 and $38,000 respectively.
Gulf Pointe Capital Lease
Agreement
On
September 30, 2008, the Company entered into a master lease agreement (the
“Master Lease”) with Gulf Pointe Capital, LLC (“Gulf Pointe”) which allows us to
obtain lease capital from time to time up to an aggregate of $130,000 of lease
financing. The terms under this lease are consistent with the terms of our other
lease arrangements. Three members of our Board of Directors Steven Jones, Peter
Petersen and Marvin Jaffe, are affiliated with Gulf Pointe and recused
themselves from both sides of all negotiations concerning this transaction. In
consideration for entering into the Master Lease with Gulf Pointe, the Company
issued a warrant to purchase 32,475 shares of common stock to Gulf Pointe with
an exercise price of $1.08 per share and a five year term. Such warrant vests
25% on issuance and then on a pro rata basis as amounts are drawn under the
Master Lease. The warrant was valued at approximately $11,000 using the
Black-Scholes option pricing model, and the warrant cost is being expensed as it
vests. At the end of the term of any lease schedule under the Master Lease, the
Company’s options are as follows: (a) purchase not less than all of the
equipment for its then fair market value not to exceed 15% of the original
equipment cost, (b) extend the lease term for a minimum of six months, or (c)
return not less than all the equipment at the conclusion of the lease term. On
September 30, 2008, we also entered into the first lease schedule under the
Master Lease which provided for the sale/leaseback of approximately $130,000 of
used laboratory equipment (“Lease Schedule No. 1”). Lease Schedule No. 1 has a
30 month term and a lease rate factor of 0.0397/month, which equates to monthly
payments of $5,155 during the term.
On
February 9, 2009, we amended our Master Lease with Gulf Pointe to increase the
maximum size of the facility to $250,000. As part of this amendment, we
terminated the original warrant agreement, dated September 30, 2008, and
replaced it with a new warrant to purchase 83,333 shares of our common stock.
Such new warrant has a five year term, an exercise price of $0.75 per share and
the same vesting schedule as the original warrant. The replacement warrant was
valued using the Black-Scholes option pricing model and the value did not
materially differ from the valuation of the original warrant it replaced. On
February 9, 2009, we also entered into a second schedule under the Master Lease
for the sale/leaseback of approximately $118,000 of used laboratory equipment
(“Lease Schedule No. 2”). Lease Schedule No. 2 has a 30 month term at the same
lease rate factor per month as Lease Schedule No. 1, which equates to monthly
payments of $4,690 during the term.
F-8
NEOGENOMICS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2010
NOTE F — 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).
END OF
FINANCIAL STATEMENTS.
F-9
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders of NeoGenomics, Inc.:
We
have audited the accompanying consolidated balance sheets of NeoGenomics, Inc.
(the “Company”), as of December 31, 2009 and 2008, and the related consolidated
statements of operations, stockholders’ equity and cash flows for the years then
ended. These financial statements are the responsibility of the
Company's management. Our responsibility is to express an opinion on
these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States of America). Those
standards require that we plan and perform the audits to obtain reasonable
assurance about whether the financial statements are free of material
misstatement. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting. Our audits included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An
audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis
for our opinion.
In
our opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of the Company as of December 31, 2009
and 2008, and the results of its operations and its cash flows for the years
then ended, in conformity with accounting principles generally accepted in the
United States of America.
/s/
Kingery & Crouse, P.A
Certified
Public Accountants
Tampa,
FL
March
26, 2010
F-10
NEOGENOMICS,
INC.
CONSOLIDATED
BALANCE SHEETS AS OF DECEMBER 31, 2009 and 2008
|
2009
|
2008
|
||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
and cash equivalents
|
$ | 1,631,069 | $ | 468,171 | ||||
Restricted
Cash
|
1,000,000 | - | ||||||
Accounts
receivable (net of allowance for doubtful accounts of $589,012 and
$358,642, respectively)
|
4,632,219 | 2,913,531 | ||||||
Inventories
|
601,802 | 491,459 | ||||||
Other
current assets
|
655,046 | 482,408 | ||||||
Total
current assets
|
8,520,136 | 4,355,569 | ||||||
PROPERTY AND EQUIPMENT
(net of accumulated depreciation of $2,786,704 and $1,602,594
respectively)
|
4,339,560 | 2,875,297 | ||||||
OTHER
ASSETS
|
85,604 | 64,509 | ||||||
TOTAL
ASSETS
|
$ | 12,945,300 | $ | 7,295,375 | ||||
LIABILITIES AND STOCKHOLDERS’
EQUITY
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable
|
$ | 1,968,884 | $ | 1,512,427 | ||||
Accrued
compensation
|
1,308,160 | 736,552 | ||||||
Accrued
expenses and other liabilities
|
464,830 | 358,265 | ||||||
Short-term
portion of equipment capital leases
|
1,482,326 | 636,900 | ||||||
Revolving
credit line
|
552,033 | 1,146,850 | ||||||
Total
current liabilities
|
5,776,233 | 4,390,994 | ||||||
LONG
TERM LIABILITIES
|
||||||||
Long-term
portion of equipment capital leases
|
1,525,728 | 1,403,271 | ||||||
TOTAL
LIABILITIES
|
7,301,961 | 5,794,265 | ||||||
Commitments
and contingencies
|
||||||||
STOCKHOLDERS’
EQUITY
|
||||||||
Common
stock, $.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)
|
37,185 | 32,117 | ||||||
Additional
paid-in capital
|
23,761,784 | 17,381,810 | ||||||
Accumulated
deficit
|
(18,155,630 | ) | (15,912,817 | ) | ||||
Total
stockholders’ equity
|
5,643,339 | 1,501,110 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 12,945,300 | $ | 7,295,375 |
See
notes to consolidated financial statements.
F-11
NEOGENOMICS,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2009 AND 2008
2009
|
2008
|
|||||||
NET
REVENUE
|
$ | 29,469,054 | $ | 20,015,319 | ||||
COST
OF REVENUE
|
14,254,227 | 9,353,852 | ||||||
GROSS
MARGIN
|
15,214,827 | 10,661,467 | ||||||
OPERATING
EXPENSES
|
||||||||
General
and administrative
|
10,056,944 | 8,178,953 | ||||||
Sales
and marketing
|
6,885,396 | 3,366,503 | ||||||
Total
operating expenses
|
16,942,340 | 11,545,456 | ||||||
INCOME
/ (LOSS) FROM OPERATIONS
|
(1,727,513 | ) | (883,989 | ) | ||||
OTHER
INCOME / (EXPENSE):
|
||||||||
Other
income
|
17,091 | 9,926 | ||||||
Interest
expense
|
(532,391 | ) | (308,523 | ) | ||||
Loss
on investment
|
- | (200,000 | ) | |||||
Other
income / (expense) – net
|
(515,300 | ) | (498,597 | ) | ||||
NET
LOSS
|
$ | (2,242,813 | ) | $ | (1,382,586 | ) | ||
NET LOSS PER
SHARE - Basic and Diluted
|
$ | (0.06 | ) | $ | (0.04 | ) | ||
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING – Basic and Diluted
|
34,638,502 | 31,506,824 |
See notes
to consolidated financial statements.
F-12
NEOGENOMICS,
INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE YEARS ENDED DECEMBER 31, 2009 AND 2008
Additional
|
||||||||||||||||||||
Common Stock
|
Paid-In
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
Balances,
December 31, 2007
|
31,391,660 | $ | 31,391 | $ | 16,820,954 | $ | (14,530,231 | ) | $ | 2,322,114 | ||||||||||
Common
stock issuances for cash
|
49,260 | 49 | 45,094 | - | 45,143 | |||||||||||||||
Transaction
fees and expenses
|
- | - | (8,411 | ) | - | (8,411 | ) | |||||||||||||
Stock
compensation expense - warrants
|
- | - | 132,584 | - | 132,584 | |||||||||||||||
Exercise
of stock options
|
88,500 | 89 | 23,656 | - | 23,745 | |||||||||||||||
Shares
issued to Fusion Capital, net of issuance costs (Note I)
|
417,500 | 418 | (48,266 | ) | - | (47,848 | ) | |||||||||||||
Shares
issued for registration penalties
|
170,088 | 170 | 170,019 | - | 170,189 | |||||||||||||||
Stock
compensation expense
|
- | - | 246,180 | - | 246,180 | |||||||||||||||
Net
loss
|
- | - | - | (1,382,586 | ) | (1,382,586 | ) | |||||||||||||
Balances,
December 31, 2008
|
32,117,008 | 32,117 | 17,381,810 | (15,912,817 | ) | 1,501,110 | ||||||||||||||
Common
stock issuances to Abbott
|
3,500,000 | 3,500 | 4,763,500 | - | 4,767,000 | |||||||||||||||
Common
stock issuance ESPP plan
|
68,672 | 69 | 86,721 | - | 86,790 | |||||||||||||||
Transaction
fees and expenses
|
- | - | (236,576 | ) | - | (236,576 | ) | |||||||||||||
Stock
compensation expense - warrants
|
- | - | 67,738 | - | 67,738 | |||||||||||||||
Exercise
of stock options
|
55,215 | 55 | 3,055 | - | 3,110 | |||||||||||||||
Exercise
of warrants
|
519,183 | 519 | 637,510 | - | 638,029 | |||||||||||||||
Common
stock issuance to CEO for cash
|
625,000 | 625 | 499,375 | - | 500,000 | |||||||||||||||
Shares
issued for purchase of assets
|
300,000 | 300 | 185,700 | - | 186,000 | |||||||||||||||
Stock
compensation expense - options
|
- | - | 372,951 | - | 372,951 | |||||||||||||||
Net
loss
|
- | - | - | (2,242,813 | ) | (2,242,813 | ) | |||||||||||||
Balances,
December 31, 2009
|
37,185,078 | $ | 37,185 | $ | 23,761,784 | $ | (18,155,630 | ) | $ | 5,643,339 |
See notes
to consolidated financial statements.
F-13
NEOGENOMICS,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2009 AND 2008
2009
|
2008
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
Loss
|
$ | (2,242,813 | ) | $ | (1,382,586 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
1,184,109 | 740,564 | ||||||
Loss
on investments
|
- | 200,000 | ||||||
Amortization
of debt issue costs
|
68,649 | 54,006 | ||||||
Stock
based compensation
|
372,951 | 246,180 | ||||||
Non-cash
consulting expenses
|
67,738 | 132,584 | ||||||
Other
non-cash expenses
|
- | 8,862 | ||||||
Provision
for bad debts
|
2,154,567 | 1,789,577 | ||||||
Changes
in assets and liabilities, net:
|
||||||||
(Increase)
decrease in accounts receivable, net of write-offs
|
(3,873,255 | ) | (1,466,357 | ) | ||||
(Increase)
decrease in inventories
|
(110,343 | ) | (186,709 | ) | ||||
(Increase)
decrease in prepaid expenses
|
(195,793 | ) | (63,057 | ) | ||||
(Increase)
decrease in other current assets
|
(21,094 | ) | (3,934 | ) | ||||
Increase
(decrease) in legal contingency
|
- | (375,000 | ) | |||||
Increase
(decrease) in accounts payable and other liabilities
|
1,094,867 | 167,564 | ||||||
NET
CASH USED IN OPERATING ACTIVITIES
|
(1,500,417 | ) | (138,306 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Purchases
of property and equipment
|
(963,740 | ) | (501,781 | ) | ||||
NET
CASH USED IN INVESTING ACTIVITIES
|
(963,740 | ) | (501,781 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Advances
(repayments) from/to revolving credit facility
|
(594,818 | ) | 1,146,850 | |||||
Restricted
cash
|
(1,000,000 | ) | - | |||||
Repayment
of capital lease obligations
|
(809,599 | ) | (377,641 | ) | ||||
Proceeds
from issuance of capital lease on owned assets
|
273,119 | 67,999 | ||||||
Issuance
of common stock and warrants for cash , net of transaction
expenses
|
5,758,353 | 60,477 | ||||||
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
3,627,055 | 897,685 | ||||||
NET
CHANGE IN CASH AND CASH EQUIVALENTS
|
1,162,898 | 257,598 | ||||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF YEAR
|
468,171 | 210,573 | ||||||
CASH
AND CASH EQUIVALENTS, END OF YEAR
|
$ | 1,631,069 | $ | 468,171 | ||||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION
|
||||||||
Interest
paid
|
$ | 463,742 | $ | 256,323 | ||||
Equipment
leased under capital leases
|
$ | 1,777,484 | $ | 1,207,863 | ||||
Common
stock issued for the purchase of assets
|
$ | 186,000 | $ | - | ||||
Income
taxes paid
|
$ | - | $ | - |
See notes
to consolidated financial statements.
F-14
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008
NOTE A – NATURE OF BUSINESS AND BASIS OF
PRESENTATION
NeoGenomics,
Inc., a Nevada Company, was formed in 1998 under the name of American
Communications Enterprises, Inc. (“ACE”, the “Parent”, or the “Parent
Company”).
NeoGenomics
Laboratories, Inc., a Florida company (“NEO”, “NeoGenomics”
or “Subsidiary”) was formed in June 2001, and agreed to be acquired
by ACE in a reverse acquisition in November 2001. On March 3, 2009,
we changed the name of the Subsidiary from NeoGenomics Inc, to NeoGenomics
Laboratories, Inc. NeoGenomics operates as a certified “high
complexity” clinical laboratory in accordance with the federal government’s
Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), and is dedicated to
the delivery of clinical diagnostic services to pathologists, oncologists,
urologists, hospitals, and other laboratories throughout the United
States.
ACE
succeeded to NEO’s name in January, 2002, and NeoGenomics remains a wholly-owned
subsidiary of the Parent Company. (NEO and ACE are collectively referred to as
“we”, “us”, “our” or the “Company”).
The
accompanying consolidated financial statements include the accounts of the
Parent and the Subsidiary. All significant intercompany accounts and
balances have been eliminated in consolidation.
Certain
amounts in the prior year’s consolidated financial statements have been
reclassified to conform to the current year presentation.
NOTE B – SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
FASB Accounting Standards
Codification
In June
2009, the FASB issued the FASB Accounting Standards Codification (the
“Codification”), which replaced all existing FASB accounting and reporting
standards. Effective for financial statements for interim and annual periods
ending after September 15, 2009, the Codification is the single source of
authoritative U.S. generally accepted accounting principles (GAAP) for
non-governmental entities. Rules and interpretive releases of the Securities and
Exchange Commission (SEC) under authority of federal securities laws are also
sources of authoritative GAAP for SEC registrants and are referenced in the
Codification. References to the Codification are identified by their Accounting
Standards Codification (“ASC”) Topic number and, as appropriate, their Subtopic,
Section and Subsection number. Effective July 1, 2009, changes to
authoritative U.S. GAAP are communicated through Accounting Standards Updates
(“ASU”). Implementation of the Codification had no effect on the Company’s
financial statements, except for changes in the manner in which authoritative
guidance is now referenced.
Use of
Estimates
The
Company prepares its consolidated financial statements in conformity with
accounting principles generally accepted in the United States of
America. These principles require management to make estimates,
judgments and assumptions that affect the reported amounts of assets,
liabilities, revenues and expenses, together with amounts disclosed in the
related notes to the consolidated financial statements. Actual
results and outcomes may differ from management’s estimates, judgments and
assumptions. Significant estimates, judgments and assumptions used in
these consolidated financial statements include, but are not limited to, those
related to revenues, accounts receivable and related reserves, contingencies,
useful lives and recovery of long-term assets, income and other taxes, and the
fair value of stock-based compensation. These estimates, judgments,
and assumptions are reviewed periodically and the effects of material revisions
in estimates are reflected in the consolidated financial statements
prospectively from the date of the change in estimate.
Revenue
Recognition
The
Company recognizes revenues in accordance with the Securities and Exchange
Commission’s (the “Commission”) Staff Accounting Bulletin Topic 13.A.1 (ASC
605-10-S99-1)No. 104, “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.
F-15
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
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 horizon’s in analyzing historical experience.
Cost of
Revenue
Cost of
revenue consists primarily of lab related materials and supplies, salaries
related to laboratory personnel, transportation of patient samples to and from
our laboratories, allocated facility costs, and depreciation of equipment used
to deliver the Company’s services.
Accounts Receivable and
Allowance for Doubtful Accounts
Accounts
receivable are reported at realizable value, net of allowance for doubtful
accounts (the “Allowance”), which is estimated and recorded in the period the
related revenue is recorded based on the historical collection experience for
each type of payor. In addition, the Allowance is adjusted
periodically, based upon an evaluation of historical collection experience with
specific payors, payor types, and other relevant factors, including regularly
assessing the state of our billing operations in order to identify issues which
may impact the collectability of receivables or reserve
estimates. Revisions to the Allowance are recorded as an adjustment
to bad debt expense within general and administrative expenses. After
appropriate collection efforts have been exhausted, specific receivables deemed
to be uncollectible are charged against the Allowance in the period they are
deemed uncollectible. Recoveries of receivables previously
written-off are recorded as credits to the Allowance.
Statement of Cash
Flows
For
purposes of the statement of cash flows, we consider all highly liquid
investments purchased with an original maturity of three months or less to be
cash equivalents.
Fair Value of Financial
Instruments and Concentrations of Credit Risk
The
carrying value of cash and cash equivalents, restricted cash, accounts
receivable, accounts payable, accrued expenses and other liabilities, amounts
outstanding under our revolving credit facility, and other current assets and
liabilities are considered reasonable estimates of their respective fair values
due to their short-term nature. The Company maintains its cash and
cash equivalents with domestic financial institutions that the Company believes
to be of high credit standing. The Company believes that, as of
December 31, 2009, its concentration of credit risk related to cash and cash
equivalents was not significant. The carrying value of the Company’s
long-term capital lease obligations approximates its fair value based on the
current market conditions for similar instruments.
Concentrations
of credit risk with respect to revenue and accounts receivable are primarily
limited to certain clients to whom the Company provides a significant volume of
its services, and to specific payors of our services such as Medicare and
individual insurance companies. The Company’s client base consists of
a large number of geographically dispersed clients diversified across various
customer types. The Company continues to focus its sales efforts to
decrease the dependency on any given source of revenue and decrease its credit
risk from any one large client or payor type, and these efforts decrease our
credit risk. 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.
F-16
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
The
Company orders the majority of its FISH probes from one vendor and as a result
of their dominance of that marketplace and the absence of any competitive
alternatives, if they were to have a disruption and not have inventory available
it could have a material effect on our business. This risk cannot be
completely offset due to the fact that they have patent protection which limits
other vendors from supplying these probes.
Inventories
Inventories,
which consist principally of testing supplies, are valued at the lower of cost
or market, using the first-in, first-out method (FIFO).
Property and
Equipment
Property
and equipment are recorded at cost, net of accumulated depreciation and
amortization. Property and equipment generally includes purchases of
items with a cost greater than $1,000 and a useful life greater than one
year. Depreciation and amortization are computed on a straight line
basis over the estimated useful lives of the assets.
Leasehold
improvements are amortized over the related lease terms or their estimated
useful lives. Property and equipment acquired under capital leases
are depreciated over the related lease terms or the useful lives of the
assets. The Company periodically reviews the estimated useful lives
of property and equipment. Changes to the estimated useful lives are recorded
prospectively from the date of the change. Upon retirement or sale,
the cost of the assets disposed of and the related accumulated depreciation are
removed from the accounts and any resulting gain or loss is included in income
(loss) from operations. Repairs and maintenance costs are expensed as
incurred.
Income
Taxes
We
compute income taxes in accordance with ASC Topic 740 Income
Taxes. Under ASC-740, deferred taxes are recognized for the tax
consequences of temporary differences by applying enacted statutory rates
applicable to future years to differences between the financial statement
carrying amounts and the tax bases of existing assets and
liabilities. Also, the effect on deferred taxes of a change in tax
rates is recognized in income in the period that included the enactment
date. Temporary differences between financial and tax reporting arise
primarily from the use of different depreciation methods for property and
equipment as well as impairment losses and the timing of recognition of bad
debts.
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with FASB ASC Topic
718 Compensation – Stock Compensation. ASC 718 requires recognizing
compensation costs for all share-based payment awards made to employees and
directors based upon the awards’ grant-date fair value. The standard
covers employee stock options, restricted stock, and other equity
awards.
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’ vesting periods. The
Company estimates an expected forfeiture rate, which is factored into the
determination of the Company’s periodic expense.
Tax Effects of Stock-Based
Compensation
We will
only recognize a tax benefit from windfall tax deductions for stock-based awards
in additional paid-in capital if an incremental tax benefit is realized after
all other tax attributes currently available have been
utilized.
F-17
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Net Loss Per Common
Share
We
compute loss per share in accordance with ASC Topic 260 Earnings Per
Share. Under the provisions of ASC 260, basic net loss per share is
computed by dividing the net loss available to common stockholders by the
weighted average number of common shares outstanding during the
period. Diluted net loss per share is computed by dividing the net
loss for the period by the weighted average number of common and common
equivalent shares outstanding during the period. During the years
ended December 31, 2009 and 2008, we reported net loss per share and,
accordingly, common equivalent shares outstanding as of December 31, 2009 and
2008, which consisted of employee stock options and warrants issued to
consultants, providers of financing to the Company and others, were excluded
from diluted net loss per common share calculations as of such dates because
they were anti-dilutive. As a result, basic and diluted loss per
share were equivalent.
Recent
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 below.
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.
NOTE
C – LIQUIDITY
Our
consolidated financial statements are prepared using accounting principles
generally accepted in the United States of America applicable to a going
concern, which contemplates the realization of assets and liquidation of
liabilities in the normal course of business. On November
5, 2008, we entered into a common stock purchase agreement with Fusion Capital
Fund II, LLC . The 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
(see Note J). On February 1, 2008, we entered into a revolving credit
facility with CapitalSource Finance, LLC, 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 (see Note H). We believe we have
adequate resources to meet our operating commitments for the next year 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.
F-18
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
NOTE
D – PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following at December 31, 2009 and
2008:
2009
|
2008
|
Estimated
Useful Lives in
Years
|
||||||||||
Equipment
|
$ | 4,991,886 | $ | 3,450,449 |
3-7
|
|||||||
Leasehold
improvements
|
618,876 | 111,114 |
3-5
|
|||||||||
Furniture
& fixtures
|
351,832 | 247,366 |
7
|
|||||||||
Computer
hardware
|
486,852 | 276,520 |
3
|
|||||||||
Computer
software
|
541,948 | 382,154 |
3
|
|||||||||
Assets
not yet placed in service
|
134,870 | 10,288 |
-
|
|||||||||
Subtotal
|
7,126,264 | 4,477,891 | ||||||||||
Less
accumulated depreciation and amortization
|
(2,786,704 | ) | (1,602,594 | ) | ||||||||
Property
and equipment, net
|
$ | 4,339,560 | $ | 2,875,297 |
Depreciation
and amortization expense on property and equipment, including leased assets, for
the years ended December 31, 2009 and 2008, was $1,184,109 and $740,564,
respectively.
Property
and equipment under capital leases, included above, consists of the following at
December 31, 2009 and 2008:
2009
|
2008
|
|||||||
Equipment
|
$ | 3,413,595 | $ | 2,273,864 | ||||
Furniture
& fixtures
|
159,864 | 106,119 | ||||||
Computer
hardware
|
298,305 | 120,821 | ||||||
Computer
software
|
225,644 | 142,814 | ||||||
Leasehold
Improvements
|
233,386 | - | ||||||
Assets
not yet placed in service
|
84,347 | - | ||||||
Subtotal
|
4,415,141 | 2,643,618 | ||||||
Less
accumulated depreciation and amortization
|
(1,441,234 | ) | (656,797 | ) | ||||
Property
and equipment under capital leases, net
|
$ | 2,973,907 | $ | 1,986,821 |
NOTE
E – INCOME TAXES
We
recognized losses for financial reporting purposes for the years ended December
31, 2009 and 2008, in the accompanying consolidated statements of
operations. Accordingly, no provisions for income taxes and/or
deferred income taxes payable have been provided in the accompanying
consolidated financial statements.
At
December 31, 2009 and 2008, we had net operating loss carryforwards of
approximately $9,888,662 and $7,520,000, respectively. The
significant difference between this amount and our accumulated deficit arises
primarily from certain stock based compensation that is considered to be a
permanent difference. Assuming our net operating loss carryforwards
are not disallowed because of certain “change in control” provisions of the
Internal Revenue Code, these net operating loss carryforwards expire in various
years through the year ending December 31, 2028. However, we
have established a valuation allowance to fully reserve our deferred income tax
assets as such assets did not meet the required asset recognition standard
established by ASC Topic 740. Our valuation allowance increased by approximately
$1,350,000 during the year ended December 31, 2009.
F-19
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
At
December 31, 2009 and 2008, our current and non-current deferred income tax
assets (assuming an effective income tax rate of approximately 40.5%, which
includes 35% for federal taxes and 5.5% for state taxes) consisted of the
following:
2009
|
2008
|
|||||||
Net
current deferred income tax asset:
|
||||||||
Allowance
for doubtful accounts
|
$ | 227,200 | $ | 138,300 | ||||
Less
valuation allowance
|
(227,200 | ) | (138,300 | ) | ||||
Total
|
$ | - | $ | - |
Net
non-current deferred income tax asset:
|
||||||||
Net
operating loss carryforwards
|
$ | 3,856,600 | $ | 2,933,000 | ||||
Accumulated
depreciation and impairment
|
(543,000 | ) | (881,000 | ) | ||||
Subtotal
|
3,313,600 | 2,052,000 | ||||||
Less
valuation allowance
|
(3,313,600 | ) | (2,052,000 | ) | ||||
Total
|
$ | - | $ | - |
NOTE
F – EMPLOYEE STOCK OPTIONS, STOCK PURCHASE PLAN AND WARRANTS
Stock Option
Plan
On March
3, 2009, the Company’s Board of Directors approved the Amended and Restated
Equity Incentive Plan (the “Amended Plan”), which amended and restated the
Equity Incentive Plan, originally effective as of October 14, 2003, and
previously amended and restated effective as of October 31, 2006. The
Amended Plan allows for the award of equity incentives, including stock options,
stock appreciation rights, restricted stock awards, stock bonus awards, deferred
stock awards, and other stock-based awards to certain employees, directors, or
officers of, or key advisers or consultants to, the Company or its
subsidiaries. The Amended Plan provides that the maximum aggregate number
of shares of the Company’s common stock reserved and available for issuance
under the Amended Plan is 6,500,000 and that the Amended Plan will expire on
March 3, 2019.
As of
December 31, 2009, option and stock awards for 5,161,652 shares were
outstanding, including 350,000 options issued outside of the Amended Plan to
Robert Gasparini, the Company’s President and Chief Science Officer, and option
and stock awards for 641,264 shares had been exercised, leaving a total of
1,047,084 shares available for future option and stock
awards. Options typically expire after 5 or 10 years and generally
vest over 3 or 4 years, but each grant’s expiration, vesting and exercise price
provisions are determined at the time the awards are granted by the Compensation
Committee of the Board of Directors or by the Chairman and Chief Executive
Officer by virtue of authority delegated to him by the Compensation
Committee.
We
account for option and stock awards under the Amended Plan in accordance with
ASC Topic 718 Compensation – Stock Compensation, which requires the measurement
and recognition of compensation expense in the Company’s statement of operations
for all share-based option and stock awards, based on estimated grant-date fair
values.
ASC Topic
718 requires us to estimate the fair value of stock-based option awards on the
date of grant using an option-pricing model. The grant-date fair
value of the award is recognized as expense over the requisite service period
using the straight-line method. In accordance with ASC Topic 718, the
estimated stock-based compensation expense to be recognized is reduced by an
estimate of the annualized rate of stock option forfeitures.
F-20
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
We
estimate the grant-date fair value of stock-based option awards using a
trinomial lattice model. This model is affected by our stock price on
the date of the grant as well as assumptions regarding a number of highly
complex and subjective variables. These variables include the
expected term of the option, expected risk-free rates of return, the expected
volatility of our common stock, and expected dividend yield, each of which is
more fully described below. The assumptions for expected term and
expected volatility are the two assumptions that significantly affect the grant
date fair value.
Expected Term: The
expected term of an option is the period of time that the option is expected to
be outstanding. The average expected term is determined using a
trinomial lattice simulation model.
Risk-free Interest
Rate: We base the risk-free interest rate used in the
trinomial lattice valuation method on the implied yield at the grant date of the
U.S. Treasury zero-coupon issue with an equivalent term to the stock-based award
being valued. Where the expected term of a stock-based award does not
correspond with the term for which a zero coupon interest rate is quoted, we use
the nearest interest rate from the available maturities.
Expected Stock Price
Volatility: Effective January 1, 2006 until December 31,
2008, we evaluated the assumptions used to estimate volatility and determined
that, under SAB 107, we should use a blended average of our volatility and the
volatility of certain peer companies. We believe that the use of this
blended average peer volatility is more reflective of market conditions and a
better indicator of our expected volatility due to the limited trading history
available for our Company since its last change of control, prior to which we
operated under a different business model. Effective January 1, 2009
since we had sufficient historical data since our last change of control we
began to use our own historical weekly volatility because that was more
reflective of market conditions.
Dividend
Yield: Because we have never paid a dividend and do not expect
to begin doing so in the foreseeable future, we have assumed a 0% dividend yield
in valuing our stock-based awards.
The fair
value of stock option awards granted during the years ended December 31, 2009
and 2008 was estimated as of the grant date using a trinomial lattice model with
the following weighted average assumptions:
2009
|
2008
|
|||||||
Expected
term (in years)
|
4.1 | 3.5 | ||||||
Risk-free
interest rate (%)
|
1.9 | % | 2.0 | % | ||||
Expected
volatility (%)
|
59 | % | 42 | % | ||||
Dividend
yield (%)
|
0 | % | 0 | % | ||||
Weighted
average fair value/share at grant date
|
$ | 0.42 | $ | 0.22 |
The
status of our stock options and stock awards are summarized as
follows:
Number
|
Weighted
Average |
|||||||
Of
Shares
|
Exercise
Price |
|||||||
Outstanding
at December 31, 2007
|
2,796,044 | $ | 0.81 | |||||
Granted
|
1,405,000 | 0.87 | ||||||
Exercised
|
(88,500 | ) | 0.27 | |||||
Canceled
|
(388,122 | ) | 1.32 | |||||
Outstanding
at December 31, 2008
|
3,724,422 | 0.79 | ||||||
Granted
|
2,371,598 | 1.00 | ||||||
Exercised
|
(55,215 | ) | 0.26 | |||||
Canceled
|
(879,153 | ) | 1.01 | |||||
Outstanding
at December 31, 2009
|
5,161,652 | 0.86 | ||||||
Exercisable
at December 31, 2009
|
2,982,343 | 0.73 |
F-21
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
As
described in Note G, on March 16, 2009, the Company entered into an employment
agreement with Douglas M. VanOort (the “Employment Agreement”). The
Employment Agreement provided for the grant to Mr. VanOort of an option under
the Amended Plan to purchase 1,000,000 shares of the Company’s common stock, at
an exercise price of $0.80 per share (the closing market price of the company’s
common stock on March 13, 2009, the preceding business day). 500,000
shares of common stock subject to the option will vest according to the
following schedule (i) 200,000 shares will vest on March 16, 2010 (provided that
if Mr. VanOort’s employment is terminated by the Company without “cause” then
the pro rata portion of such 200,000 shares up until the date of termination
shall vest); (ii) 12,500 shares will vest each month beginning on April 16, 2010
until March 16, 2011; (iii) 8,000 shares will vest each month beginning on April
16, 2011 until March 16, 2012 and (iv) 4,500 shares will vest each month
beginning on April 16, 2012 until March 16, 2013. 500,000 shares of
common stock subject to the option will vest based on the achievement of
certain performance metrics by the Company. Any unvested portion of
the option described above will vest in the event of a change in control of the
Company.
The
following table summarizes information about our options outstanding at December
31, 2009:
Options Outstanding, Expected to Vest
|
Options Exercisable
|
|||||||||||||||||||||||
Range of
Exercise
Prices ($)
|
Number
Outstanding
|
Weighted
Average
Remaining
Contractual
Life (Years)
|
Weighted
Average
Exercise
Price
|
Number
Exercisable
|
Weighted
Average
Remaining
Contractual
Life (Years)
|
Weighted
Average
Exercise
Price
|
||||||||||||||||||
0.00
– 0.30
|
996,000 | 4.8 | $ | 0.25 | 996,000 | 4.8 | $ | 0.25 | ||||||||||||||||
0.31
– 0.46
|
59,500 | 5.4 | 0.35 | 59,500 | 5.4 | 0.35 | ||||||||||||||||||
0.47
– 0.61
|
113,500 | 5.8 | 0.50 | 113,500 | 5.8 | 0.50 | ||||||||||||||||||
0.62
– 0.83
|
2,178,596 | 5.8 | 0.77 | 888,330 | 5.7 | 0.75 | ||||||||||||||||||
0.84
– 1.08
|
478,996 | 4.2 | 0.99 | 330,039 | 4.1 | 0.97 | ||||||||||||||||||
1.09
– 1.47
|
612,163 | 5.3 | 1.36 | 348,331 | 6.0 | 1.40 | ||||||||||||||||||
1.48
– 1.84
|
722,897 | 5.5 | 1.58 | 246,643 | 6.7 | 1.53 | ||||||||||||||||||
5,161,652 | 5.4 | 0.86 | 2,982,343 | 5.3 | 0.73 |
As of
December 31, 2009, the aggregate intrinsic value of all stock options
outstanding and expected to vest was approximately $3,360,000 and the aggregate
intrinsic value of currently exercisable stock options was approximately
$2,308,000. The intrinsic value of each option share is the
difference between the fair market value of NeoGenomics common stock and the
exercise price of such option share to the extent it is
“in-the-money”. Aggregate intrinsic value represents the value that
would have been received by the holders of in-the-money options had they
exercised their options on the last trading day of the year and sold the
underlying shares at the closing stock price on such day. The
intrinsic value calculation is based on the $1.50 closing stock price of
NeoGenomics Common Stock on December 31, 2009, the last trading day of
2009. The total number of in-the-money options outstanding and
exercisable as of December 31, 2009 was 2,785,700.
The total
intrinsic value of options exercised during the years ended December 31, 2009
and 2008 was approximately $80,000 and $44,000,
respectively. Intrinsic value of exercised shares is the total value
of such shares on the date of exercise less the cash received from the option
holder to exercise the options. The total cash proceeds received from
the exercise of stock options was approximately $3,110 and $24,000 for the years
ended December 31, 2009 and 2008, respectively.
F-22
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
The total
fair value of options granted during the years ended December 31, 2009 and 2008
was approximately $986,000 and $310,000, respectively. The
total fair value of option shares vested during the years ended
December 31, 2009 and 2008 was approximately $233,000 and
$220,000.
Stock
compensation cost recognized for the years ended December 31, 2009 and 2008 was
approximately $373,000 and $246,000, respectively. We will only recognize a tax
benefit from windfall tax deductions for stock-based awards in additional
paid-in capital if an incremental tax benefit is realized after all other tax
attributes currently available have been utilized. As of December 31, 2009,
there was approximately $639,000 of total unrecognized stock-based compensation
cost, net of expected forfeitures, related to unvested stock options granted
under the Amended Plan. This cost is expected to be recognized over a
weighted-average period of 1.7 years.
Employee Stock Purchase
Plan
Effective
January 1, 2007, the Company began sponsoring an Employee Stock Purchase Plan
(“ESPP”), under which eligible employees may purchase Common Stock, by means of
limited payroll deductions, at a 5% discount from the fair market value of the
Common Stock as of specific dates. In accordance with ASC Topic
718-50 Compensation – Stock Compensation – Employee Share Purchase Plans, the
ESPP is considered non-compensatory and does not require the recognition of
compensation cost because the discount offered to employees does not exceed
5%. Shares issued pursuant to this plan were 68,443 and 49,260 for
the period ended December 31, 2009 and 2008, respectively.
Common Stock
Warrants
From time
to time, the company issues warrants to purchase its common
stock. These warrants have been issued for consulting services, in
connection with the company’s credit facilities or in connection with sales of
its common stock, and in connection with employment agreements or for
compensation of directors. These warrants are valued using an option
pricing model and using the volatility, market price, strike price, risk-free
interest rate and dividend yield appropriate at the date the warrants were
issued. Stock compensation cost recognized for the years ended
December 31, 2009 and 2008 was approximately $68,000 and $133,000,
respectively.
Warrant
activity is summarized as follows:
Shares
|
Weighted
Average
Exercise Price |
|||||||
Warrants
outstanding, December 31, 2007
|
5,805,363 | $ | 0.59 | |||||
Granted
|
32,475 | 1.08 | ||||||
Warrants
outstanding, December 31, 2008
|
5,837,838 | 0.61 | ||||||
Granted
|
738,333 | 1.00 | ||||||
Exercised
|
(519,183 | ) | 1.27 | |||||
Expired
|
(130,091 | ) | 1.35 | |||||
Cancelled
|
(35,147 | ) | 1.08 | |||||
Warrants
outstanding, December 31, 2009
|
5,891,750 | $ | 0.59 |
F-23
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
The
following table summarizes information on warrants outstanding on December 31,
2009:
Number
outstanding |
Exercise
price |
Issued
|
Expire
|
||||
2,500,000
|
$ | 0.31 |
03/23/2005
|
01/20/2011
|
|||
1,600,000
|
0.26 |
01/21/2006
|
01/20/2011
|
||||
35,000
|
0.30 |
02/13/2006
|
02/12/2011
|
||||
35,000
|
0.68 |
05/16/2006
|
05/15/2011
|
||||
15,000
|
0.62 |
02/03/2009
|
02/03/2012
|
||||
100,000
|
1.49 |
03/15/2007
|
03/13/2012
|
||||
550,000
|
1.50 |
06/06/2007
|
06/05/2012
|
||||
348,417
|
1.50 |
06/06/2007
|
06/05/2012
|
||||
83,333
|
0.75 |
02/09/2009
|
02/08/2014
|
||||
625,000
|
1.05 |
03/16/2009
|
03/15/2014
|
||||
5,891,750
|
$ | 0.59 |
On
February 3, 2009, in connection with consulting services rendered to the
Company, we issued warrants to purchase 30,000 shares of common stock at $0.62
per share. Warrants for 15,000 shares were exercised prior to
December 31, 2009.
As
described in Note L, in connection with our lease facility with Gulf Pointe
Capital, LLC, on February 9, 2009 we issued warrants to purchase 83,333 shares
of common stock, which warrants replaced 32,475 warrants previously issued in
connection with that facility.
As
described in Note J, on March 16, 2009, the Company entered into an employment
agreement with Douglas M. VanOort and in connection with that agreement also
entered into a warrant agreement pursuant to which Mr. VanOort may purchase up
to 625,000 shares of the Company’s common stock at an exercise price of $1.05
per share. The warrants become exercisable in five tranches, with 20% of
the warrants being exercisable immediately and a further 20% becoming
exercisable on the first day on which the closing price per share of the
Company’s common stock has reached or exceeded, for 20 consecutive trading days,
$3.00, $4.00, $5.00 and $6.00 per share, respectively. In the event
of a change in control of the Company in which the consideration payable to each
common stockholder of the Company in connection with such change in control has
a deemed value of at least $4.00 per share, then the warrants will immediately
become exercisable. 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 warrants are exercisable,
then the rights under the warrant agreement with respect to the portion of the
warrants not yet exercisable as of the date of termination will immediately
terminate.
In August
2009, 419,153 of the 767,570 warrants originally issued in connection with the
June 2007 sale of common stock were exercised and the Company received proceeds
of $628,730.
During
2009, Mr. O’Leary exercised 100,000 warrants in a cash-less transaction per the
terms of the agreements. The company issued 85,030 shares to settle
this exercise.
F-24
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
NOTE
G – COMMITMENTS AND CONTINGENCIES
Operating
Leases
The
Company leases its laboratory and office facilities under non-cancelable
operating leases. These operating leases expire at various dates
through April 2012 and generally require the payment of real estate taxes,
insurance, maintenance and operating costs. The Company has
approximately 26,000 square feet of office and laboratory space at our corporate
headquarters in Fort Myers, Florida. In addition, we maintain
laboratory and office space in Irvine, California, Chatsworth California and
Nashville, Tennessee.
The
minimum aggregate future obligations under non-cancelable operating leases as of
December 31, 2009 are as follows:
Years ending December 31,
|
||||
2010
|
$ | 906,818 | ||
2011
|
632,280 | |||
2012
|
115,708 | |||
2013
|
- | |||
2014
|
- | |||
Total
minimum lease payments
|
$ | 1,654,806 |
Rent
expense for the years ended December 31, 2009 and 2008 was $816,838 and
$754,138, respectively and is included in costs of revenues and in general and
administrative expenses, depending on the allocation of work space in each
facility. Certain of the Company’s facility leases include rent
escalation clauses. The Company normalizes rent expense on a
straight-line basis over the term of the lease for known changes in lease
payments over the life of the lease.
Purchase
Commitments
The
company had open purchase commitments with 2 vendors of laboratory equipment for
approximately $500,000 of equipment at December 31, 2009. This
equipment was delivered during 2010.
US Labs
Settlement
On
October 26, 2006, Accupath Diagnostics Laboratories, Inc. d/b/a US Labs, a
California corporation (“US Labs”) filed a complaint in the Superior Court of
the State of California for the County of Los Angeles (entitled Accupath
Diagnostics Laboratories, Inc. v. NeoGenomics, Inc., et al., Case No. BC 360985)
(the “Lawsuit”) against the Company and Robert Gasparini, as an individual, and
certain other employees and non-employees of NeoGenomics (the “Defendants”) with
respect to claims arising from discussions with current and former employees of
US Labs. On March 18, 2008, we reached a preliminary agreement to
settle US Labs' claims, and in accordance with ASC Topic 450 Contingencies, as of December 31, 2007 we
accrued a $375,000 loss contingency, which consisted of $250,000 to provide for
the Company's expected share of this settlement, and $125,000 to provide for the
Company's share of the estimated legal fees up to the date of
settlement.
On April
23, 2008, the Company and US Labs entered into a Settlement Agreement and
Release (the "Settlement Agreement") whereby both parties agreed to settle and
resolve all claims asserted in and arising out of the aforementioned lawsuit.
Pursuant to the Settlement Agreement, the Defendants were required to pay
$500,000 to US Labs, of which $250,000 was paid with funds from the Company's
insurance carrier in May 2008 and the remaining $250,000 was paid by the Company
in equal installments of $31,250 commencing on May 31,
2008. Under the terms of the Settlement Agreement, there were
certain provisions agreed to in the event of default. As of December
31, 2008, the full settlement amount had been paid and no events of default had
occurred.
F-25
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Private Placement of Common
Stock and Registration Penalties
As of
December 31, 2007, we had not been able to effectively complete the Registration
Statement required to be filed in connection with our June 2007 private
placement (the “Private Placement”) and pursuant to the terms of the Private
Placement, we accrued $282,000 in estimated penalties as liquidated damages,
which were expected to be incurred for the period through June 2008, the date we
anticipated to be able to effectively complete the Registration Statement. The
Registration Statement became effective on July 1, 2008. In
September, 2008, the Company paid $40,500 in cash and issued 170,088 shares of
common stock valued at approximately $1.00 per share for an aggregate payment of
$210,688 to the holders of the Private Placement shares to settle the penalties
due. The remaining $71,412 in accrued penalties was reversed in
September, 2008 as certain shareholders had previously sold their shares, thus
forfeiting their rights to any penalties.
Employment
Contracts
Robert
Gasparini
On March
12, 2008, we entered into an employment agreement with Robert Gasparini, our
President and Chief Scientific Officer, to extend his employment with the
Company for an additional four year term. This employment agreement
was retroactive to January 1, 2008 and provides that it will automatically renew
after the initial four year term for one year increments unless either party
provides written notice to the other party of their intention to terminate the
agreement 90 days before the end of the initial term (or any renewal
term). The employment agreement specifies an initial base salary of
$225,000/year with specified salary increases tied to achieving revenue
goals. Mr. Gasparini is also entitled to receive cash bonuses for any
given fiscal year in an amount equal to 30% of his base salary if he meets
certain targets established by the Board of Directors. In addition, Mr.
Gasparini was granted 784,000 stock options at an exercise price of $0.80 and
with a seven year term so long as Mr. Gasparini remains an employee of the
Company. These options are scheduled to vest according to the passage
of time and the meeting of certain performance-based milestones. Mr.
Gasparini's employment agreement also specifies that he is entitled to four
weeks of paid vacation per year and other insurance benefits. In the event that
Mr. Gasparini is terminated without cause by the Company, the Company has agreed
to pay Mr. Gasparini's base salary and maintain his benefits for a period of a
year.
Jerome
Dvonch
On June
14, 2008, we entered into an employment agreement with Jerome Dvonch, our
Principal Accounting Officer, to extend his employment with the Company for an
additional four year term and provides that it will automatically renew after
the initial four year term for one year increments unless either party provides
written notice to the other party of their intention to terminate the agreement
30 days before the end of the initial term (or any renewal term). The
employment agreement specifies an initial base salary of $150,000/year and does
not allow for an increase during the first 24 months of the term. Mr.
Dvonch is also entitled to receive cash bonuses for any given fiscal year if he
meets certain targets established by the Board of Directors. In addition, Mr.
Dvonch was granted 100,000 stock options with an exercise price of $1.04 and
with a seven year term so long as Mr. Dvonch remains an employee of the
Company. These options are scheduled to vest according to the passage
of time and the meeting of certain performance-based milestones. Mr.
Dvonch's employment agreement also specifies that he is entitled to four weeks
of paid vacation per year and other insurance benefits. In the event that Mr.
Dvonch is terminated without cause by the Company, the Company has agreed to pay
Mr. Dvonch's base salary and maintain his benefits for a period of six
months.
Douglas
VanOort
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.
F-26
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
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
October 28, 2009, the Company appointed Douglas M. 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.
Grant
Carlson
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 and
Marketing. 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. 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 months.
F-27
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
George
Cardoza
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 per 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.
Jack
G. Spitz
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 per
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.
NOTE
H – REVOLVING CREDIT AND SECURITY AGREEMENT
On
February 1, 2008, our subsidiary, NeoGenomics Laboratories, Inc., (“the
Borrower”), entered into a Revolving Credit and Security Agreement (the “Credit
Facility” or “Credit Agreement”) with CapitalSource Finance LLC
(“CapitalSource”), the terms of which provide for borrowings based on eligible
accounts receivable up to a maximum borrowing of $3,000,000, as defined in the
Credit Agreement. Subject to the provisions of the Credit Agreement,
CapitalSource will make advances to us from time to time during the three year
term, and the Credit Facility may be drawn, repaid and redrawn from time to time
as permitted under the Credit Agreement.
Interest
on outstanding advances under the Credit Facility are payable monthly in arrears
on the first day of each calendar month at an annual rate based on the one-month
LIBOR plus 3.25%, subject to a LIBOR floor of 3.14%. At December 31,
2009, the effective rate of interest was 6.39%. On December 31, 2009,
the available credit under the Credit Facility was approximately $2,448,000 and
the outstanding borrowing was $552,000 after netting compensating cash on
hand.
To secure
the payment and performance in full of the Obligations (as defined in the Credit
Agreement), we granted CapitalSource a continuing security interest in and lien
upon, all of our rights, title and interest in and to our Accounts (as defined
in the Credit Agreement), which primarily consist of accounts receivable and
cash balances held in lock box accounts. Furthermore, pursuant to the
Credit Agreement, the Parent guaranteed the punctual payment when due, whether
at stated maturity, by acceleration or otherwise, of all of the Obligations. The
Parent guaranty is a continuing guarantee and shall remain in force and effect
until the indefeasible cash payment in full of the Guaranteed Obligations (as
defined in the Credit Agreement) and all other amounts payable under the Credit
Agreement.
F-28
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
On
November 3, 2008, the Company and CapitalSource signed a first amendment to the
Credit Agreement. This amendment increased the amount allowable under the
Credit Agreement to pay towards the settlement of the US Labs lawsuit to
$250,000 from $100,000 and documented other administrative agreements between
NeoGenomics and CapitalSource.
On April
14, 2009, the Parent Company, NeoGenomics Laboratories, Inc. (the wholly owned
subsidiary of the Parent Company) (“Borrower”) and CapitalSource Finance LLC
(“CapitalSource”) (as agent for CapitalSource Bank) entered into a Second
Amendment to Revolving Credit and Security Agreement (the “Loan
Amendment”). The Loan Amendment, among other things, amends that
certain Revolving Credit and Security Agreement dated February 1, 2008 as
amended by that certain First Amendment to Revolving Credit and Security
Agreement dated November 3, 2008 (as amended, the “Loan Agreement”) to (i)
provide that through December 31, 2009, the Borrower must maintain Minimum
Liquidity (as defined in the Loan Agreement) of not less than $500,000, (ii)
amend the definitions of “Fixed Charge Coverage Ratio” and “Fixed Charges”,
(iii) amend the definition of “Permitted Indebtedness” to increase the amount of
permitted capitalized lease obligations and indebtedness incurred to purchase
goods secured by certain purchase money liens and (iv) amend and update certain
representations, warranties and schedules. In addition, pursuant to
the Loan Amendment, CapitalSource waived the following events of default under
the Loan Agreement: (i) the failure of the Borrower to comply with
the fixed charge coverage ratio covenant for the test period ending December 31,
2008, (ii) the failure of the Borrower to notify CapitalSource of the change of
Borrower’s name to NeoGenomics Laboratories, Inc. and to obtain CapitalSource’s
prior consent to the related amendment to Borrower’s Articles of
Incorporation, (iii) the failure of the Parent Company and the
Borrower to obtain CapitalSource’s prior written consent to the amendment of the
Parent Company’s bylaws to allow for the size of the Parent Company’s Board of
Directors to be increased to eight members and (iv) the failure of the Borrower
to notify CapitalSource of the filing of an immaterial complaint by the Borrower
against a former employee of the Borrower. The Company paid
CapitalSource Bank a $25,000 amendment fee in connection with the Loan
Amendment.
On March
26, 2010, we entered into an amendment to the credit facility agreement with
Capital Source (see Note O).
NOTE
I – ABBOTT SUPPLY AGREEMENT
On July
24, 2009, NeoGenomics Laboratories and Abbott Molecular Inc., a Delaware
corporation (“Abbott Molecular”), entered into a Strategic Supply Agreement (the
“Supply Agreement”). The Supply Agreement, among other things, provides for
Abbott Molecular to supply materials with which NeoGenomics intends to develop
its own FISH (fluorescence in situ hybridization)-based test for the diagnosis
of malignant melanoma in skin biopsy specimens (the “Melanoma
LDT”).
Pursuant
to the terms of the Supply Agreement, Abbott Molecular has agreed to supply
NeoGenomics with such of Abbott Molecular’s analyte specific reagents (“ASRs”)
that NeoGenomics may request for the purpose of NeoGenomics’ evaluation and
determination as to which ASRs to include in its Melanoma LDT. Once the ASRs
have been identified by NeoGenomics, Abbott Molecular has agreed to supply such
ASRs (subject to certain limitations) to NeoGenomics. If NeoGenomics identifies
for inclusion in the Melanoma LDT one or more ASRs that are not currently
marketed or sold commercially by Abbott Molecular as individual stand-alone
products, then the Supply Agreement provides that Abbott Molecular will supply
such ASRs to NeoGenomics on an exclusive basis in the United States and Puerto
Rico (the “Exclusive ASRs”), provided that Abbott Molecular may also supply such
exclusive ASRs to certain of its academic collaborators for research and limited
clinical purposes. Abbott Molecular’s obligation to supply the Exclusive ASRs on
an exclusive basis is subject to NeoGenomics meeting certain revenue thresholds
with respect to the Melanoma LDT. Except for the ASRs supplied for evaluation
purposes (which are to be supplied at no cost), the Supply Agreement provides
that the price of the ASRs supplied by Abbott Molecular will include both a base
and a premium component.
In the
event that Abbott Molecular obtains FDA approval for its own in vitro diagnostic
test for aid in diagnosis of malignant melanoma in skin biopsy specimens, the
Supply Agreement contemplates a means by which NeoGenomics may offer such
FDA-approved test to its customers instead of the Melanoma LDT.
F-29
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Pursuant
to the Supply Agreement, Abbott Molecular also granted to NeoGenomics a first
right to develop two additional laboratory developed tests relating to certain
specified disease states using Abbott Molecular ASRs or other
products.
The
initial term of the Supply Agreement expires on December 31, 2019. The Supply
Agreement also contemplates two year renewal terms under certain circumstances.
The parties may terminate the Supply Agreement prior to the expiration of the
term under certain circumstances.
The
Supply Agreement provides (subject to certain limitations) that Abbott Molecular
may convert the Supply Agreement into a non-exclusive agreement or terminate the
Supply Agreement if NeoGenomics does not develop and launch the Melanoma LDT
within six (6) months after the date on which Abbott Molecular supplies ASRs
(other than ASRs supplied for evaluation purposes) to NeoGenomics.
Abbott
Molecular may terminate the Supply Agreement following a change of control
involving NeoGenomics and certain designated companies. In such event Abbott
Molecular would pay to NeoGenomics (or its successor) a termination payment
based upon a pre-defined formula.
NOTE
J – EQUITY TRANSACTIONS
Warrant Exercises from the
2007 Private Placement
During
the period from May 31, 2007 through June 6, 2007, we sold 2,666,667 shares of
our Common Stock to ten unaffiliated accredited investors (the “Investors”) at a
price of $1.50 per share in a Private Placement of our Common Stock (the
“Private Placement”). The Private Placement generated gross proceeds
to the Company of $4.0 million, and after estimated transaction costs, the
Company received net cash proceeds of approximately $3.8
million.
On August
15, 2007 our Board of Directors voted to issue warrants to purchase 533,334
shares of our Common Stock to the investors who purchased shares in the Private
Placement. Such warrants have an exercise price of $1.50 per share
and are exercisable for a period of two years.
In August
2009, 419,153 warrants were exercised that were attributable to this equity
raise and the Company received proceeds of $628,700.
Common Stock Purchase
Agreement
On
November 5, 2008, we entered into a common stock purchase agreement (the “Stock
Agreement”) with Fusion Capital Fund II, LLC (“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. In consideration for
entering into this Stock Agreement, on October 10, 2008, we issued to Fusion
17,500 shares of our common stock (valued at $14,700 on the date of issuance)
and $17,500 as a due diligence expense reimbursement. In addition, on
November 5, 2008, we issued to Fusion 400,000 shares of our common stock (valued
at $288,000 on the date of issuance) as a commitment fee. Concurrently
with entering into the Stock Agreement, we entered into a registration rights
agreement with Fusion. Under the registration rights agreement, we agreed
to file a registration statement with the SEC covering the 417,500 shares that
have already been issued to Fusion and at least 3.0 million shares that may be
issued to Fusion under the Stock Agreement. Presently, we expect to sell
no more than the initial 3.0 million shares to Fusion during the term of this
Stock Agreement. The Company filed a registration statement on Form S-1
dated November 28, 2008, and on February 5, 2009 the filing became
effective.
Under the
Stock Agreement, after the SEC has declared effective the registration statement
related to the transaction, we have the right to sell to Fusion shares of our
common stock from time to time in amounts between $50,000 and $1.0 million,
depending on the market price of our common stock. The purchase price of
the shares related to any future funding under the Stock Agreement will be based
on the prevailing market prices of our stock at the time of such sales without
any fixed discount, and the Company will control the timing and amount of any
sales of shares to Fusion. Fusion shall not have the right or 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 per share. The Stock
Agreement may be terminated by us at any time at our discretion without any cost
to us. There are no negative covenants, restrictions on future funding
from other sources, penalties, further fees or liquidated damages in the
agreement.
F-30
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Given our
current liquidity position from cash on hand and our availability under our
Credit Facility with CapitalSource (see Note H), we have no immediate plans to
issue common stock under the Stock Agreement. If and when we do elect to sell
shares to Fusion under this agreement, we expect to do so opportunistically and
only under conditions deemed favorable by the Company. Any proceeds
received by the Company from sales under the Stock Agreement will be used for
general corporate purposes, working capital, and/or for expansion
activities.
Asset Purchase
Agreements
On
February 2, 2009, we issued 300,000 shares of restricted stock, valued at
$186,000 based on the February 2, 2009 closing price of the Company’s common
stock on the OTC Bulletin Board, in connection with two agreements to purchase
the assets (primarily laboratory equipment) of two laboratories, including
settlement of certain amounts due to the owners.
Share Purchase by the
Douglas VanOort Living Trust
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”). Douglas M VanOort is Chairman of the Company’s Board
of Directors and Chief Executive Officer. 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”). These warrants had an aggregate fair value of
$160,267. 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.
F-31
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Common Stock Purchase
Agreement and Registration Rights Agreement with Abbott
Laboratories
On July
24, 2009, NeoGenomics, Inc. entered into a Common Stock Purchase Agreement (the
“Common Stock Purchase Agreement”) with Abbott Laboratories, an Illinois
corporation (“Abbott”), and consummated the issuance and sale to Abbott, for an
aggregate purchase price of $4,767,000, of 3,500,000 shares of common stock,
$0.001 par value per share (the “Shares”). Pursuant to the terms of the Common
Stock Purchase Agreement, Abbott is prohibited from selling or otherwise
transferring the Shares until January 20, 2010.
On July
24, 2009, NeoGenomics, Inc. and Abbott also entered into a Registration Rights
Agreement (the “Registration Rights Agreement”) that, among other things, grants
certain demand and piggyback registration rights to Abbott with respect to the
Shares.
NOTE
K – EQUIPMENT CAPITAL LEASES
From time
to time, we have entered into various capital leases, primarily to fund
purchases of laboratory and other equipment, including the lease agreements
described below.
Gulf Pointe Capital Lease
Agreement
On
September 30, 2008, we entered into a master lease agreement (the “Master
Lease”) with Gulf Pointe Capital, LLC (“Gulf Pointe”) which provided for
$130,000 of lease financing after it was determined that the lease facility with
LTI described below would not allow for the leasing of certain used and other
types of equipment. Three members of our Board of
Directors, Steven Jones, Peter Petersen and Marvin Jaffe, are affiliated with
Gulf Pointe and recused themselves from both sides of all negotiations
concerning this transaction. The terms under this lease are
consistent with the terms of our other lease arrangements and provided for the
sale/leaseback of approximately $130,000 of used laboratory equipment. The lease
has a 30 month term and a lease rate factor of 0.0397/month, which equates to
monthly payments of $5,155 during the term. In consideration for entering into
the Master Lease, the Company issued 32,475 common stock warrants to Gulf Pointe
with an exercise price of $1.08 and a five year term. The warrants
were valued at approximately $11,000 using the Black-Scholes option pricing
model. At the end of the lease term, the Company’s options are as
follows: (a) purchase not less than all of the equipment for its then
fair market value, not to exceed 15% of the original equipment cost, (b) extend
the lease term for a minimum of six months, or (c) return not less than all the
equipment at the conclusion of the lease term.
On
February 9, 2009, we amended our Master Lease with GulfPointe to increase the
maximum size of the facility to $250,000 and entered into a second schedule
under the Master Lease for the sale/leaseback of approximately $118,000 of used
laboratory equipment. This second lease has a 30 month term at the same lease
rate factor per month as the first lease, which equates to monthly payments of
$4,690 during the term. As part of this amendment, we terminated the original
warrant agreement dated September 30, 2008 and replaced it with a new warrant to
purchase 83,333 shares of our common stock. Such new warrants have a
five year term, an exercise price of $0.75 per share and the same vesting
schedule as the original warrants. The replacement warrants were valued using
the Black-Scholes option pricing model and the value did not materially differ
from the valuation of the original warrants they replaced.
Leasing Technologies
International Lease Agreement
On
November 5, 2008, we entered into a Master Lease Agreement with Leasing
Technologies International, Inc (the “LTI Lease”). The LTI Lease
establishes the general terms and conditions pursuant to which we may lease up
to $1,000,000 of equipment. Advances under the lease line may be made
for one year by executing equipment schedules for each advance. The
lease term of any equipment schedules issued under the lease line will be for 36
months. The lease rate factor applicable for each equipment schedule
is 0.0327/month. If we make use of the entire lease line, the monthly
rent would be $32,700. Monthly rent for the leased equipment is
payable in advance on the first day of each month. At the end of the term of
each equipment schedule, we may: (a) renew the lease with respect to such
equipment for an additional 12 months at fair market value; (b) purchase the
equipment at fair market value, which price will not be less than 10% of cost
nor more than 14% of cost; (c) extend the term for an additional six months at
35% of the monthly rent paid during the initial term, after which the equipment
may be purchased for the lesser of fair market value or 8% of cost; or (d)
return the equipment subject to a remarketing charge equal to 6% of
cost.
F-32
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
In 2008,
we entered into Lease Schedule No. 1 to the LTI Lease for $437,300 and on May
22, 2009, July 29, 2009 and September 22, 2009, entered into Lease Schedules
Nos. 2, 3 and 4 for $442,300, $40,066, and $29,218, respectively, which were
used to fund laboratory and computer equipment.
As of
December 31, 2009, we have been advanced $948,884 under the LTI Lease. We cannot
receive any further advances under the LTI Lease.
Wells Fargo Lease
Agreement
On
October 2, 2009, we entered into a Master Lease Agreement with Wells Fargo
Equipment Finance, Inc. (the “Wells Fargo Lease”). The Wells Fargo Lease
establishes the general terms and conditions pursuant to which we may lease up
to $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 for $265,200 which was
used to acquire laboratory equipment. Supplement No. 1, which is being accounted
for as a capital lease, has a term of 60 months with monthly payments of $5,396
and a $1 final purchase payment at termination.
On
January 14, 2010, we entered into Lease Supplement No. 2 for $424,000 which was
used to acquire laboratory equipment. Supplement No. 2, which will be accounted
for as a capital lease, has a term of 60 months with monthly payments of $8,628
and a $1 final purchase payment at termination.
After
entering into Supplement No. 2 on January 14, 2010, we have $60,800 available
for further advances under the Wells Fargo Lease.
SunTrust Lease
Agreement
On
October 28, 2009, we entered into an equipment lease agreement with SunTrust
Equipment Finance & Leasing Corp. (the “SunTrust Lease”). The SunTrust Lease
establishes the general terms and conditions pursuant to which we may lease up
to $1.5 million in equipment and other property. Advances under the
lease line may be made by executing supplemental schedules for each advance,
which would have a term of 60 months.
On
November 12, 2009, we entered into Lease Schedule No. 1 for $428,465 which was
used to fund laboratory equipment, computer hardware and furniture and fixtures.
Schedule No. 1, which is being accounted for as a capital lease, has a term of
60 months with monthly payments of $8,434 and a $1 final purchase payment at
termination. As part of this schedule, the Subsidiary agreed to keep at least
$1,000,000 in compensating cash balances with SunTrust as long as the subsidiary
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.
On
January 19, 2010, we entered into Lease Schedule No. 2 for $289,573 which was
used to fund laboratory equipment and furniture and fixtures. Schedule 2, which
will be accounted for as a capital lease, has a term of 60 months with monthly
payments of $5,704 and a $1 final purchase payment at termination.
After
entering into Lease Schedule No. 2 on January 19, 2010, we have $781,962
available for further advances under the SunTrust Lease.
F-33
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Capital Lease
Obligations
The
Company’s capital lease obligations expire at various times through 2014 and the
weighted average interest rates under such leases approximated 13.3% at December
31, 2009. Most of these leases contain bargain purchase options that allow us to
purchase the leased property for a minimal amount upon the expiration of the
lease term. Future minimum lease payments under capital lease
obligations, including those described above, are:
Years ending December 31,
|
||||
2010
|
$ | 1,836,501 | ||
2011
|
1,058,020 | |||
2012
|
431,844 | |||
2013
|
167,863 | |||
2014
|
83,664 | |||
Total
future minimum lease payments
|
3,577,892 | |||
Less
amount representing interest
|
(569,838 | ) | ||
Present
value of future minimum lease payments
|
3,008,054 | |||
Less
current maturities
|
(1,482,326 | ) | ||
Obligations
under capital leases – long term
|
$ | 1,525,728 |
Property
and equipment acquired under capital lease agreements (see Note D) is pledged as
collateral to secure the performance of the future minimum lease payments
above.
NOTE
L – 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 and Executive Vice President of
Finance.
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 March 15, 2007, Mr. O’Leary received 50,000 stock options
for work performed for the benefit of the Company and 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 exercise.
On June
6, 2007, we issued to the six non-employees director’s of our board of directors
a total of 550,000 warrants at $1.50/share. Such warrants had an
exercise price of $1.50/share with three year vesting and a five year final
term. These warrants were valued at approximately $280,000 on the
date of issuance using the Black-Schools option pricing model and our being
expensed over the vesting period. These warrants expire in June
2012.
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.
F-34
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
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 five 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.
Gulf Pointe Capital Lease
Agreement
See Note
K for a description of our lease agreement with Gulf Pointe Capital, LLC, an
entity with which three members of our Board of Directors, Steven Jones, Peter
Petersen and Marvin Jaffe, are affiliated.
NOTE
M – POWER 3 MEDICAL PRODUCTS, INC.
On April
2, 2007, we entered into an agreement with Power3 Medical Products, Inc.,
(“Power3”) regarding the formation of a joint venture Contract Research
Organization (“CRO”) and the issuance of convertible debentures and certain
options by Power3 to us (the “Letter Agreement”). Power3 is an early
stage company engaged in the discovery, development, and commercialization of
protein biomarkers. As part of the agreement, on April 17, 2007, we
provided $200,000 of working capital to Power3 by purchasing a 6% convertible
debenture, due April 17, 2009 (the “Debenture”). We were also granted
two options to increase our stake in Power3 first to 20% and then up to 60% of
Power3’s fully diluted shares. The first option is exercisable for a
period starting on the date of purchase of the convertible debenture by
NeoGenomics and extending until the day which is the later of (y) November 16,
2007 or (z) the date that certain preconditions specified in the agreement have
been achieved.
As of
March 24, 2010, Power3 had still failed to meet at least four of the five
preconditions specified in the Letter Agreement. As a result of this
failure to meet the pre-conditions specified in the Letter Agreement, we believe
that all of our options to acquire interests in Power3 and license their
Intellectual Property are still in full force and effect and we have notified
Power3 that we are reserving all of our rights under the Letter
Agreement. We have also notified Power3 that they are in
default of their obligations under the Debenture by failing to pay interest due
since September 2008 and principal which was due April 17, 2009, and that as a
result of such default, we were demanding the accelerated payment of the full
principal and any accrued interest under the Debenture. We intend to
vigorously pursue all remedies in this matter.
NOTE
N – RETIREMENT PLAN
We
maintain a defined-contribution 401(k) retirement plan covering substantially
all employees (as defined). Our employees may make voluntary contributions
to the plan, subject to limitations based on IRS regulations and
compensation. In addition, we match any employees’ contributions on a
dollar to dollar basis up to 1% of the respective employee’s
salary. We made matching contributions of approximately $50,798 and
$41,000 during the years ended December 31, 2009 and 2008,
respectively.
NOTE
O – SUBSEQUENT EVENTS
Equipment
Leases
As
described in Note K, on January 14, 2010 and January 19, 2010, we entered into
additional capital leases under our lease facilities with Wells Fargo and
SunTrust, respectively.
F-35
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2009 and 2008 (Continued)
Third Amendment to Revolving
Credit and Security Agreement
On March
26, 2010, we entered into an amendment (the “Third Amendment”) to the credit
facility agreement with CapitalSource (see Note H), for which we paid
CapitalSource an amendment fee of $25,000. The Third Amendment waived
events of default relating to our failure to comply with the Fixed Charge
Coverage Ratio for the Test Periods ended January 31, 2010 and February 28,
2010. The Third Amendment also revised the Fixed Charge Coverage Ratio
calculation for the Test Period ending March 31, 2010 to permit us to add
amounts of unrestricted cash, unrestricted cash equivalents and unused
availability to Adjusted EBITDA for purposes of the test. For each monthly Test
Period after March 31, 2010, the calculation of the Coverage Ratio will revert
to Adjusted EBITDA, without adjustment for such amounts.
End of
Financial Statements
F-36
INFORMATION
NOT REQUIRED IN PROSPECTUS
ITEM
13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The
following table sets forth estimated expenses expected to be incurred in
connection with the issuance and distribution of the securities being
registered. The Company will pay all expenses in connection with this
offering.
Securities
and Exchange Commission Registration Fee
|
$ | 179 | ||
Printing
and Engraving Expenses
|
$ | 1,000 | ||
Accounting
Fees and Expenses
|
$ | 10,000 | ||
Legal
Fees and Expenses
|
$ | 50,000 | ||
Miscellaneous
|
$ | 3,821 | ||
TOTAL
|
$ | 65,000 |
ITEM
14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The
Company’s Articles of Incorporation provide that no director or officer of the
Company shall be personally liable to the Company or any of its stockholders for
damages for breach of fiduciary duty as a director or officer of for any act or
omission of any such director or officer; however such indemnification shall not
eliminate or limit the liability of a director or officer for (a) acts or
omissions which involve intentional misconduct, fraud or a knowing violation of
law or (b) the payment of dividends in violation of Section 78.300 of the Nevada
Revised Statutes. The Company’s Amended and Restated Bylaws (the “Bylaws”) provide that
any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative, by reason of the fact that such
person is or was a director, officer, employee or agent of the Company (or is or
was serving at the request of the Company as a director, officer, employee or
agent of another corporation, partnership, joint venture, trust or other
enterprise) shall be indemnified and held harmless by the Company to the fullest
extent permitted by Nevada law against expenses including attorneys’ fees,
judgments, fines and amounts paid in settlement actually and reasonably incurred
by such person in connection with such proceeding.
The
Bylaws also provide that the Company must indemnify any person who was or is a
party, or is threatened to be made a party, to any threatened, pending or
completed proceeding by or in the right of the Company to procure a judgment in
its favor by reason of the fact that such person is or was a director, officer,
employee or agent of the Company, or is or was serving at the request of the
Company as a director, officer, employee, or agent of another corporation,
partnership, joint venture, trust or other enterprise against costs incurred by
such person in connection with the defense or settlement of such action or suit.
Such indemnification may not be made for any claim, issue or matter as to which
such person has been adjudged by a court of competent jurisdiction, after
exhaustion of all appeals, to be liable to the Company or for amounts paid in
settlement to the Company, unless and only to the extent that the court
determines upon application that in view of all the circumstances of the case,
the person is fairly and reasonably entitled to indemnity for such expenses as
the court deems proper.
The
Bylaws provide that the Company must pay the costs incurred by any person
entitled to indemnification in defending a proceeding as such costs are incurred
and in advance of the final disposition of a proceeding; provided however, that
the Company must pay such costs only upon receipt of an undertaking by or on
behalf of such person to repay the amount if it is ultimately determined by a
court of competent jurisdiction that such person is not entitled to be
indemnified by the Company.
The
Bylaws provide that the Company may purchase and maintain insurance or make
other financial arrangements on behalf of any person who is or was a director,
officer, employee or agent of the Company, or is or was serving at the request
of the Company as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise in accordance with Section
78.752 of the Nevada Revised Statutes.
Nevada
Revised Statutes 78.751 and 78.7502 have similar provisions that provide for
discretionary and mandatory indemnification of officers, directors, employees,
and agents of a corporation. Under these provisions, such persons may be
indemnified by a corporation against expenses, including attorney’s fees,
judgment, fines and amounts paid in settlement, actually and reasonably incurred
by him in connection with the action, suit or proceeding, if he acted in good
faith and in a manner which he reasonably believed to be in or not opposed to
the best interests of the corporation and with respect to any criminal action or
proceeding had no reasonable cause to believe his conduct was
unlawful.
II-1
To the
extent that a director, officer, employee or agent has been successful on the
merits or otherwise in defense of any action, suit or proceeding, or in defense
of any claim, issue or matter, the Nevada Revised Statues provide that he must
be indemnified by the Company against expenses, including attorney’s fees,
actually and reasonably incurred by him in connection with the
defense.
Section
78.751 of the Nevada Revised Statues also provides that any discretionary
indemnification, unless ordered by a court or advanced by the Company, must be
made only as authorized in the specific case upon a determination that
indemnification of the director, officer, employee or agent is proper in the
circumstances. The determination must be made:
·
|
By
the stockholders;
|
·
|
By
the Company’s Board of Directors by majority vote of a quorum consisting
of directors who were not parties to that act, suit or
proceeding;
|
·
|
If
a majority vote of a quorum consisting of directors who were not parties
to the act, suit or proceeding cannot be obtained, by independent legal
counsel in a written opinion; or
|
·
|
If
a quorum consisting of directors who were not parties to the act, suit or
proceeding cannot be obtained, by independent legal counsel in a written
opinion.
|
Insofar
as indemnification for liabilities arising under the Securities Act, as amended,
may be permitted to directors, officers, and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or
paid by a director, officer, or controlling person in the successful defense of
any action, suit, or proceeding) is asserted by such director, officer, or
controlling person connected with the securities being registered, we will,
unless in the opinion of our counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such
issue.
ITEM
15. RECENT SALES OF UNREGISTERED SECURITIES
Except as
otherwise noted, all of the following shares were issued and options and
warrants granted pursuant to the exemption provided for under Section 4(2) of
the Securities Act.
During
the period from May 31, 2007 through June 6, 2007, we sold 2,666,667 shares of
our common stock to unaffiliated accredited investors (the “Investors”) under in
a private placement (the “Private Placement”)
at $1.50 per share. The Private Placement generated gross proceeds to the
Company of $4 million, and after estimated transaction costs, the Company
received net cash proceeds of $3.75 million. The Company also issued
warrants to purchase 98,417 shares of our common stock to Noble International
Investments, Inc. (“Noble”) in
consideration for its services as exclusive placement agent under the Private
Placement. Additionally, the Company issued to Aspen warrants to purchase
250,000 shares at
$1.50 per share in consideration for Aspen’s services in the fund raising
process of the Private Placement. The Private Placement involved the
issuance of the aforementioned unregistered securities in transactions that we
believed were exempt from registration under Rule 506 promulgated under the
Securities Act.
On June
6, 2007, the Company issued to Lewis Asset Management (“LAM”) 500,000 shares
of common stock at an exercise price of $0.26 per share and received gross
proceeds equal to $130,000 upon the exercise by LAM of warrants which had been
previously purchased from Aspen on June 6, 2007.
On August
31, 2007 the Company issued warrants to purchase 533,334 shares of its common
stock to the investors who purchased shares in the Private Placement. Such
warrants have an exercise price of $1.50 per share and are
exercisable for a period of two years. Such warrants also have a
provision for piggyback registration rights in the first year and demand
registration right in the second year. No shares underlying are being
registered hereunder.
II-2
On March
12, 2008, the Company granted an option to purchase 400,000 shares of common
stock to Robert P. Gasparini, our President and Chief Science Officer, pursuant
to the terms of his employment agreement with the Company. The option
has an exercise price of $0.80 per share and vests based on the achievement of
certain performance milestones. In the event of a change of control
of the Company, all unvested portions of the option will vest in
full.
On
September 30, 2008, the Company issued a warrant to Gulf Pointe Capital LLC
(“Gulf Pointe”)
to purchase up to 32,475 shares of our common stock. The warrant had
an exercise price of $1.08 per share and a five year term. On
February 9, 2009, we amended our Master Lease with GulfPointe to increase the
maximum size of the facility to $250,000. As part of this amendment,
we terminated the original warrant agreement, dated September 30, 2008, and
replaced it with a new warrant to purchase 83,333 shares of our common
stock. Such new warrants have a five year term, an exercise price of
$0.75/share and the same vesting schedule as the original warrant.
On
October 10, 2008, the Company issued to Fusion Capital Fund II, LLC (“Fusion
Capital”) 17,500 shares of our common stock as a due diligence
expense reimbursement. In addition, pursuant to the terms of a common
stock purchase agreement between the Company and Fusion Capital, on November 5,
2008, we issued to Fusion Capital 400,000 shares of our common stock as a
commitment fee.
On February 2, 2009, the Company
issued 300,000 shares of its common stock to the seller in connection with
two agreements to purchase the assets (primarily laboratory equipment) of two
laboratories, including settlement of certain amounts due to the owner of
such laboratories.
On March 16, 2009, the Company and the
Douglas M. VanOort Living Trust entered into a 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.
On March
16, 2009, the Company and Mr. VanOort entered into a 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 shares subject to the warrant vest pursuant
to the vesting schedule set forth in the Warrant Agreement.
On
July 24, 2009, the Company entered into a Common Stock Purchase Agreement with
Abbott Laboratories, an Illinois corporation (“Abbott”), and
consummated the issuance and sale to Abbott, for an aggregate purchase price of
$4,767,000, of 3,500,000 shares of common stock, $0.001 par value per
share.
On May 3,
2010, the Company and Steven C. Jones entered into a Warrant Agreement pursuant
to which Mr. Jones, subject to the vesting schedule set forth in such Warrant
Agreement, may purchase up to 450,000 shares of the Company’s common stock at an
exercise price of $1.50 per share.
II-3
ITEM
16. EXHIBITS
Description of Exhibit
|
Location
|
|||
3.1
|
Articles
of Incorporation, as amended
|
Incorporated
by reference to the Company’s Registration Statement on Form SB-2 as filed
with the SEC on February 10, 1999
|
||
3.2
|
Amendment
to Articles of Incorporation filed with the Nevada Secretary of State on
January 3, 2002
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on May 20, 2003
|
||
3.3
|
Amendment
to Articles of Incorporation filed with the Nevada Secretary of State on
April 11, 2003
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on May 20, 2003
|
||
3.4
|
Amended
and Restated Bylaws
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q as filed with
the SEC on May 14, 2009
|
||
4.1
|
Amended
and Restated Equity Incentive Plan effective as of March 3,
2009
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 20, 2009
|
||
5.1
|
Opinion
of Counsel
|
Incorporated
by reference to Amendment No. 1 to the Company’s Registration Statement on
Form S-1 filed with the SEC on January 22, 2009.
|
||
10.1
|
Loan
Agreement between NeoGenomics, Inc. and Aspen Select Healthcare, L.P.
dated March 23, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 30, 2005
|
||
10.2
|
Amended
and Restated Registration Rights Agreement between NeoGenomics, Inc. and
Aspen Select Healthcare, L.P. and individuals dated March 23,
2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 30, 2005
|
||
10.3
|
Guaranty
of NeoGenomics, Inc., dated March 23, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 30, 2005
|
||
10.4
|
Stock
Pledge Agreement between NeoGenomics, Inc. and Aspen Select Healthcare,
L.P., dated March 23, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 30, 2005
|
||
10.5
|
Warrants
issued to Aspen Select Healthcare, L.P., dated March 23,
2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 30, 2005
|
||
10.6
|
Security
Agreement between NeoGenomics, Inc. and Aspen Select Healthcare, L.P.,
dated March 23, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 30, 2005
|
||
10.7
|
Amended
and Restated Shareholders’ Agreement dated March 23, 2005 among
Neogenomics, Inc., a Nevada corporation, Michael Dent, Aspen Select
Healthcare, LP, John Elliot, Steven Jones and Larry
Kuhnert
|
Incorporated
by reference to the Company’s Registration Statement on Form S-1 as filed
with the SEC on November 28, 2008
|
II-4
Exhibit No.
|
Description of Exhibit
|
Location
|
||
10.8
|
Standby
Equity Distribution Agreement with Cornell Capital Partners, L.P. dated
June 6, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on June 8, 2005
|
||
10.9
|
Registration
Rights Agreement with Cornell Capital Partners, L.P. related to the
Standby Equity Distribution dated June 6, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on June 8, 2005
|
||
10.10
|
Placement
Agent Agreement with Spartan Securities Group, Ltd., related to the
Standby Equity Distribution dated June 6, 2005
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on June 8, 2005
|
||
10.11
|
Amended
and Restated Loan Agreement between NeoGenomics, Inc. and Aspen Select
Healthcare, L.P., dated March 30, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.12
|
Amended
and Restated Warrant Agreement between NeoGenomics, Inc. and Aspen Select
Healthcare, L.P., dated January 21, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.13
|
Amended
and Restated Security Agreement between NeoGenomics, Inc. and Aspen Select
Healthcare, L.P., dated March 30, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.14
|
Registration
Rights Agreement between NeoGenomics, Inc. and Aspen Select Healthcare,
L.P., dated March 30, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.15
|
Warrant
Agreement between NeoGenomics, Inc. and SKL Family Limited Partnership,
L.P. issued January 23, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.16
|
Warrant
Agreement between NeoGenomics, Inc. and Aspen Select Healthcare, L.P.
issued March 14, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.17
|
Warrant
Agreement between NeoGenomics, Inc. and Aspen Select Healthcare, L.P.
issued March 30, 2006
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 1, 2006
|
||
10.18
|
Agreement
with Power3 Medical Products, Inc. regarding the Formation of Joint
Venture & Issuance of Convertible Debenture and Related
Securities
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB, as filed with
the SEC on April 2, 2007
|
||
10.19
|
Securities
Purchase Agreement, dated April 17, 2007, by and between NeoGenomics, Inc.
and Power3 Medical Products, Inc.
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-QSB, as filed
with the SEC on May 15, 2007
|
||
10.20
|
Convertible
Debenture, dated April 17, 2007, issued by Power3 Medical Products, Inc.
to NeoGenomics, Inc. in the principal amount of $200,000
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-QSB, as filed
with the SEC on May 15, 2007
|
||
10.21
|
Letter
Agreement, by and between NeoGenomics, Inc. and Noble International
Investments, Inc.
|
Incorporated
by reference to the Company’s Registration Statement on Form SB-2 as filed
with the SEC on July 6, 2007
|
II-5
Exhibit No.
|
Description of Exhibit
|
Location
|
||
10.22
|
Subscription
Documents
|
Incorporated
by reference to the Company’s Registration Statement on Form SB-2 as filed
with the SEC on July 6, 2007
|
||
10.23
|
Investor
Registration Right Agreement
|
Incorporated
by reference to the Company’s Registration Statement on Form SB-2 as filed
with the SEC on July 6, 2007
|
||
10.24
|
Credit
Agreement, dated February 1, 2008, by and between NeoGenomics, Inc., the
Nevada corporation, NeoGenomics, Inc., the Florida corporation, and
CapitalSource Finance LLC
|
Incorporated
by reference to the Company’s Report on Form 8-K for the SEC filed
February 7, 2008.
|
||
10.25
|
Employment
Agreement, dated March 12, 2008, between Neogenomics, Inc. and Mr. Robert
P. Gasparini
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB as filed with
the SEC on April 14, 2008
|
||
10.26
|
Employment
Agreement, dated June 24, 2008, between Neogenomics, Inc. and Mr. Jerome
Dvonch
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, filed August 14, 2008
|
||
10.27
|
Common
Stock Purchase Agreement, dated November 5, 2008, between Neogenomics,
Inc., a Nevada corporation, and Fusion Capital Fund II,
LLC
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008, filed November 7,
2008
|
||
10.28
|
Registration
Rights Agreement, dated November 5, 2008, between Neogenomics, Inc., a
Nevada corporation, and Fusion Capital Fund II, LLC
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008, filed November 7,
2008
|
||
10.29
|
Master
Lease Agreement, dated November 5, 2008, between Neogenomics, Inc., a
Florida corporation, and Leasing Technologies International
Inc.
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008, filed November 7,
2008
|
||
10.30
|
Guaranty
Agreement, dated November 5, 2008, between Neogenomics, Inc., a Nevada
corporation, and Leasing Technologies International, Inc.
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008, filed November 7,
2008
|
||
10.31
|
First
Amendment to Revolving Credit and Security Agreement, dated November 3,
2008, among Neogenomics, Inc., a Florida corporation, Neogenomics, Inc., a
Nevada corporation, and CapitalSource Finance LLC
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008, filed November 7,
2008
|
||
10.32
|
Employment
Agreement, dated March 16, 2009 between Mr. Douglas M. VanOort and
NeoGenomics, Inc.
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 20, 2009
|
||
10.33
|
Subscription
Agreement dated March 16, 2009 between the Douglas M. VanOort Living Trust
and NeoGenomics, Inc.
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 20, 2009
|
||
10.34
|
Warrant
Agreement dated March 16, 2009 between Mr. Douglas M. VanOort and
NeoGenomics, Inc.
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on March 20,
2009
|
II-6
Exhibit No.
|
Description
of Exhibit
|
Location
|
||
10.35
|
Second Amendment
to Revolving Credit and Security Agreement, dated April 14,
2009, among NeoGenomics Laboratories, Inc., NeoGenomics, Inc., and
CapitalSource Finance LLC
|
Incorporated by
reference to the Company’s Annual Report on Form 10-K filed with the SEC
on April 14, 2009
|
||
10.36
|
Common
Stock Purchase Agreement dated July 24, 2009 between NeoGenomics, Inc. and
Abbott Laboratories
|
Incorporated by
reference to the Company’s Current Report on Form 8-K as filed with the
SEC on July 30, 2009
|
||
10.37
|
Registration
Rights Agreement dated July 24, 2009 between NeoGenomics, Inc. and Abbott
Laboratories
|
Incorporated by
reference to the Company’s Current Report on Form 8-K as filed with the
SEC on July 30, 2009
|
||
10.38
|
Offer
Letter dated July 22, 2009 between NeoGenomics, Inc. and Grant
Carlson
|
Incorporated by
reference to the Company’s Current Report on Form 8-K as filed with the
SEC on July 30, 2009
|
||
10.39
|
Strategic
Supply Agreement dated July 24, 2009, between NeoGenomics Laboratories,
Inc. and Abbott Molecular Inc.
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2009, filed August 7, 2009
|
||
10.40
|
Amended
and Restated Employment Agreement dated October 28, 2009 between
NeoGenomics, Inc. and Douglas M. VanOort
|
Incorporated by
reference to the Company’s Current Report on Form 8-K as filed with the
SEC on November 3, 2009
|
||
10.41
|
Offer
Letter dated November 3, 2009 between NeoGenomics Laboratories, Inc. and
George Cardoza
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K as filed with the
SEC on March 29, 2010.
|
||
10.42
|
Employment
Letter dated November 3, 2009 between NeoGenomics Laboratories, Inc. and
Jack G. Spitz
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K as filed with the
SEC on March 29, 2010.
|
||
10.43
|
Third
Amendment to Revolving Credit and Security Agreement dated March 26, 2010
between NeoGenomics Laboratories, Inc., NeoGenomics, Inc., and
CapitalSource Finance LLC
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K as filed with the
SEC on March 29, 2010.
|
||
10.44
|
Amended
and Restated Revolving Credit and Security Agreement dated April 26, 2010
between NeoGenomics Laboratories, Inc., NeoGenomics, Inc., and
CapitalSource Finance LLC
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q as filed with
the SEC on May 4, 2010
|
||
10.45
|
Consulting
Agreement dated May 3, 2010 between NeoGenomics, Inc. and Steven C.
Jones.
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q as filed with
the SEC on May 4, 2010
|
||
10.46
|
Warrant
Agreement dated May 3, 2010 between NeoGenomics, Inc. and Steven C.
Jones.
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-Q as filed with
the SEC on May 4,
2010
|
II-7
Exhibit No.
|
Description of Exhibit
|
Location
|
||
14.1
|
NeoGenomics,
Inc. Code of Ethics for Senior Financial Officers and the Principal
Executive Officer
|
Incorporated
by reference to the Company’s Current Report on Form 8-K as filed with the
SEC on April 15, 2005
|
||
21.1
|
Subsidiaries
of Neogenomics, Inc.
|
Incorporated by
reference to the Company’s Annual Report on Form 10-K filed with the SEC
on April 14, 2009
|
||
23.1
|
Consent
of Kingery & Crouse, P.A.
|
Provided
herewith
|
||
23.2
|
Consent
of Burton, Bartlett & Glogovac
|
Incorporated
by reference to Amendment No. 1 to the Company’s Registration Statement on
Form S-1 filed with the SEC on January 22, 2009.
|
||
24.1
|
Power
of Attorney
|
See
Page II-9 to the Post Effective Amendment No. 1 to Form S-1 Registration
Statement (File No. 333-155784) filed with the SEC on April 28,
2009.
|
ITEM
17. UNDERTAKINGS
The
undersigned registrant hereby undertakes:
1. To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(a) To
include any prospectus required by Section 10(a)(3) of the Securities Act of
1933;
(b) To
reflect in the prospectus any facts or events arising after the effective date
of this registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in this registration
statement. Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of securities offered
would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of
prospects filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in the volume and price represent no more than a 20%
change in the maximum aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration statement;
and
(c) To
include any material information with respect to the plan of distribution not
previously disclosed in this registration statement or any material change to
such information in the registration statement.
2. That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered herein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
3. To
remove from registration by means of a post-effective amendment any of the
securities being registered hereby which remain unsold at the termination of the
offering.
4. For
determining liability of the undersigned registrant under the Securities Act of
1933 to any purchaser in the initial distribution of the securities, the
undersigned registrant undertakes that in a primary offering of securities of
the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the
securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such
purchaser:
(a) Any
preliminary prospectus or prospectus of the undersigned registrant relating to
the offering required to be filed pursuant to Rule 424 (Sec.
230.424);
(b) Any
free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned
registrant;
(c) The
portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
II-8
(d) Any
other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act, and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of
expenses incurred or paid by a director, officer, or controlling person of the
registrant in the successful defense of any action, suit or proceeding) is
asserted by such director, officer, or controlling person in connection with the
securities being registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is
against public policy as expressed in the Act, and will be governed by the final
adjudication of such issue.
II-9
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly
caused this registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the city of Fort Myers, state of
Florida, on May 7, 2010
NEOGENOMICS,
INC.
|
||
By:
|
/s/ Douglas M. VanOort
|
|
Name:
|
Douglas
M. VanOort
|
|
Title:
|
Chairman
and Chief Executive Officer
|
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed by the following persons in the capacities and on the dates
indicated below:
Signatures
|
Title(s)
|
Date
|
||
/s/ Douglas M. VanOort
|
Chairman
of the Board and Chief Executive Officer
(Principal Executive Officer) |
May
7, 2010
|
||
Douglas
M. VanOort
|
||||
/s/ Robert P. Gasparini
|
President,
Chief Science Officer and Director
|
May
7, 2010
|
||
Robert
P. Gasparini
|
||||
/s/
Steven C. Jones
|
Executive
Vice President - Finance and Director
|
May
7, 2010
|
||
Steven
C. Jones
|
||||
/s/
George Cardoza
|
Chief
Financial Officer (Principal Financial Officer)
|
May
7, 2010
|
||
George
Cardoza
|
||||
/s/Jerome J. Dvonch
|
Director
of Finance (Principal Accounting Officer)
|
May
7, 2010
|
||
Jerome
J. Dvonch
|
||||
*
|
Director
|
May
7, 2010
|
||
Michael
T. Dent, M.D.
|
||||
*
|
Director
|
May
7, 2010
|
||
George
G. O’Leary
|
||||
*
|
Director
|
May
7, 2010
|
||
Peter
M. Peterson
|
||||
*
|
Director
|
May
7, 2010
|
||
William
J. Robison
|
||||
*
|
Director
|
May
7, 2010
|
||
Marvin
E. Jaffe
|
*By:
|
/s/Robert P. Gasparini
|
May
7, 2010
|
||
Robert
P. Gasparini
|
||||
As
Attorney-in-Fact
|
II-10