10KSB/A: Optional form for annual and transition reports of small business issuers [Section 13 or 15(d), not S-B Item 405]
Published on April 29, 2008
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20459
AMENDMENT #2
FORM
10-KSB/A
( X )
Annual Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934.
For
the Year Ended December 31, 2006
( )
Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934.
For the
transition period from __________ to __________.
Commission
File Number: 333-72097
NEOGENOMICS,
INC.
(Name
of small business issuer)
NEVADA
74-2897368
(State or other jurisdiction
of (IRS
Employer I.D. No.)
incorporation or organization)
12701 Commonwealth Drive,
Suite 9, Fort Myers, FL 33913
Address
of Principal Executive Offices:
(239)
768-0600
Issuers
telephone number
Securities
registered pursuant to Section 12(b) of the Act:
NONE
Securities
registered pursuant to Section 12(g) of the Act:
NONE
Check
whether the issuer (1) has filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the past 12 months (or
for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90
days. X Yes No
Check if
there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B contained in this form and no disclosure will be
contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by referencing Part III of this Form 10-KSB
or any amendment to this Form 10-KSB. X
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). _
Yes X No
The
issuer's revenues for the most recent fiscal year were approximately
$6,476,000.
The
aggregate market value of the voting stock held by non-affiliates of the
registrant at March 29, 2007 was approximately $23,227,159 (Based on 14,889,205
shares held by non-affiliates and a closing share price of $1.56/share on March
29, 2007). Shares of common stock held by each officer and director
and by each person who owns more than 10% of the outstanding common stock have
been excluded in that such persons may be deemed to be
affiliates. This determination of affiliate status is not necessarily
a conclusive determination for other purposes.
As of
March 29, 2007, 27,695,984 shares of common stock were outstanding.
Transitional
small business disclosure format. _
Yes X No
1
PART
I
FORWARD-LOOKING
STATEMENTS
This Form 10-KSB contains
“forward-looking statements” relating to NeoGenomics, Inc., a Nevada
corporation (referred to individually as the “Parent Company” or collectively
with all of its subsidiaries as “NeoGenomics” or the “Company” in this Form
10-KSB), which represent the Company’s current expectations or beliefs
including, but not limited to, statements concerning the Company’s operations,
performance, financial condition and growth. For this purpose, any statements
contained in this Form 10-KSB that are not statements of historical fact are
forward-looking statements. Without limiting the generality of the foregoing,
words such as “may”, “anticipation”, “intend”, “could”, “estimate”, or
“continue” or the negative or other comparable terminology are intended to
identify forward-looking statements. These statements by their nature involve
substantial risks and uncertainties, such as credit losses, dependence on
management and key personnel, variability of quarterly results, and the ability
of the Company to continue its growth strategy and competition, certain of which
are beyond the Company’s control. Should one or more of these risks or
uncertainties materialize or should the underlying assumptions prove incorrect,
actual outcomes and results could differ materially from those indicated in the
forward-looking statements.
Any forward-looking statement speaks
only as of the date on which such statement is made, and the Company undertakes
no obligation to update any forward-looking statement or statements to reflect
events or circumstances after the date on which such statement is made or to
reflect the occurrence of unanticipated events. New factors emerge from time to
time and it is not possible for management to predict all of such factors, nor
can it assess the impact of each such factor on the business or the extent to
which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
2
ITEM
1. DESCRIPTION
OF BUSINESS
NeoGenomics, Inc., a Nevada corporation
(referred to individually as the “Parent Company” or collectively with all of
its subsidiaries as “NeoGenomics” or the “Company” in this Form 10-KSB) is the
registrant for SEC reporting purposes. Our common stock is listed on
the NASDAQ Over-The-Counter Bulletin Board (the “OTCBB”) under the symbol
“NGNM.”
NeoGenomics
operates cancer-focused testing laboratories that specifically target the
rapidly growing genetic and molecular testing segment of the medical laboratory
industry. Headquartered in Fort Myers, Florida, the Company’s growing
network of laboratories currently offers the following types of testing services
to pathologists, oncologists, urologists, hospitals, and other laboratories
throughout the United States:
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;
and
|
|
d)
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 and prognosis of
various types of cancer.
The
genetic and molecular testing segment of the medical laboratory industry is the
most rapidly growing niche of the market. Approximately six years
ago, the World Health Organization reclassified cancers as genetic
anomalies. This growing awareness of the genetic root behind most
cancers combined with advances in technology and genetic research, including the
complete sequencing of the human genome, have made possible a whole new set of
tools to diagnose and treat diseases. This has opened up a vast
opportunity for laboratory companies that are positioned to address this growing
market segment.
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. This type of testing yields relatively low average
revenue per test. 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. The higher complexity AP tests typically involve more labor
and are more technology intensive than clinical lab tests. Thus AP
tests generally result in higher average revenue per test than clinical lab
tests.
Genetic
and molecular testing typically involves analyzing chromosomes, genes or base
pairs of DNA or RNA for abnormalities. Genetic and molecular testing
have become important and highly accurate diagnostic tools over the last five
years. 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
3
MD or PhD level) to certify results and typically yields the highest average revenue per test of the three market segments. The following chart shows the differences between the genetic and molecular niche and other segments of the medical laboratory industry. Up until approximately five years ago, the genetic and molecular testing niche was considered to be part of the Anatomic Pathology segment, but given its rapid growth, it is now more routinely broken out and accounted for as its own segment.
COMPARISON
OF THE MEDICAL LABORATORY MARKET SEGMENTS (1)
Attributes
|
Clinical
|
Anatomic Pathology
|
Genetic/Molecular
|
Testing
Performed On
Testing
Volume
Physician
Involvement
Malpractice
Ins. Required
Other
Professionals Req.
Level
of Automation
Diagnostic
in Nature
Types
of Diseases Tested
Typical
per Price/Test
Estimated
Size of Market
Estimated
Annual Growth Rate
|
Blood,
Urine
High
Low
Low
None
High
Usually
Not
Many
Possible
$5
- $35/Test
$25
- $30 Billion
4%
-5%
|
Tissue/Cells
Low
High
- Pathologist
High
None
Low-Moderate
Yes
Primarily
to Rule out Cancer
$25
- $500/Test
$10
- $12 Billion
6%
– 7%
|
Chromosomes/Genes/DNA
Low
Low
- Medium
Low
Cyto/Molecular
geneticist
Moderate
Yes
Rapidly
Growing
$200
- $1,000/Test
$4
- $5 Billion (2)
25+%
|
Established
Competitors
|
Quest
Diagnostics
LabCorp
Bio
Reference Labs
DSI
Laboratories
Hospital
Labs
Regional
Labs
|
Quest
Diagnostics
LabCorp
Genzyme
Genetics
Ameripath
Local
Pathologists
|
Genzyme
Genetics
Quest
Diagnostics
LabCorp
Major
Universities
|
(1)
Derived from industry analyst reports
(2)
Includes flow cytometry testing, which historically has been classified under
anatomic pathology.
NeoGenomics’,
primary focus is to provide high complexity laboratory testing for the
community-based pathology and oncology marketplace. Within these key
market segments, we currently provide our services to pathologists and
oncologists in the United States that perform bone marrow and/or peripheral
blood sampling for the diagnosis of liquid tumors (leukemias and lymphomas) and
archival tissue referral for analysis of solid tumors such as breast
cancer. A secondary strategic focus targets community-based
urologists, due to the availability of UroVysion®, a
FISH-based test for the initial diagnosis of bladder cancer and early detection
of recurrent disease. 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, not in academic centers, due
to ease of local access,. Moreover, within the community-based
pathologist segment it is not our intent to willingly compete with our customers
for testing services that they may seek to perform
themselves. Fee-for-service pathologists for example, derive a
significant portion of their annual revenue from the interpretation of biopsy
specimens. Unlike other larger laboratories, which strive to perform
100% of such testing services themselves, we do not intend to compete with our
customers for such specimens. Rather, our high complexity cancer testing focus
is a
4
natural extension of and complementary to many of the services that our community-based customers often perform within their own practices. As such, we believe our relationship as a non-competitive consultant, empowers these physicians 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
continue to make progress growing our testing volumes and revenue beyond our
historically focused effort in Florida due to our expanding field sales
footprint. As of March 31, 2007, NeoGenomics’ sales organization
totaled 9 individuals. Recent, key hires included our Vice President
of Sales & Marketing, and various sales managers and representatives in the
Northeastern, Southeastern, and Western states. We intend to continue adding
sales representatives on a quarterly basis throughout the year As more sales
representatives are added, the base of our business outside of Florida will
continue to grow and ultimately eclipse that which is generated within the
state.
We are
successfully competing in the marketplace based on the quality and
comprehensiveness of our test results, and our innovative flexible levels of
service, industry-leading turn-around times, regionalization of laboratory
operations and ability to provide after-test support to those physicians
requesting consultation. 2006 saw the introduction of our Genetic
Pathology Solutions (GPS) product that provides summary interpretation of
multiple testing platforms all in one consolidated report. Response
from clients has been very favorable and provides another option for those
customers that require a higher degree of customized service.
Another
important service was initiated in December 2006 when we became the first
laboratory to offer technical-component only (tech-only) FISH testing to the key
community-based pathologist market segment. NeoFISH has been
enthusiastically received and has provided our sales team with another
differentiating product to meet the needs of our target community-based
pathologists. With NeoFISH these customers are able to retain a
portion of the overall testing revenue from such FISH specimens themselves,
which serves to much better align their interests with those of NeoGenomics than
what might otherwise be possible with larger laboratory
competitors.
We
believe NeoGenomics average 3-5 day turn-around time for our cytogenetics
services remains an industry-leading benchmark. The timeliness of
results continues to increase the usage patterns of cytogenetics and act as a
driver for other add-on testing requests by our referring
physicians. Based on anecdotal information, we believe that typical
cytogenetics labs have 7-14 day turn-around times on average with some labs
running as high as 21 days. Traditionally, longer turn-around times
for cytogenetics tests have resulted in fewer tests being ordered since 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
available. We believe our turn-around times result in our referring
physicians requesting more of our testing services in order to augment or
confirm other diagnostic tests, thereby giving us a significant competitive
advantage in marketing our services against those of other competing
laboratories.
In 2006
we began an aggressive campaign to form new laboratories around the country that
will allow us to regionalize our operations to be closer to our
customers. 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. Informal surveys of
customers and prospects uncovered a desire to do business with a laboratory with
national breadth but with a more local presence. In such a scenario,
specimen integrity, turnaround-time
5
of results, client service support, and interaction with our medical staff are all enhanced. In 2006, NeoGenomics achieved the milestone of opening two other laboratories to complement our headquarters in Fort Myers, Florida. NeoGenomics facilities in Nashville, Tennessee and Irvine, California received the appropriate state and CLIA licensure and are now receiving live specimens. As situations dictate and opportunities arise, we will continue to develop and open new laboratories, seamlessly linked together by our optimized Laboratory Information System (LIS), to better meet the regionalized needs of our customers.
2006 also
saw the initial establishment of the NeoGenomics Contract Research Organization
(“CRO”) division based at our Irvine, CA facility. This division was
created to take advantage of our core competencies in genetic and molecular high
complexity testing and act as a vehicle to compete for research projects and
clinical trial support contracts in the biotechnology and pharmaceutical
industries. The CRO division will also act as a development conduit
for the validation of new tests which can then be transferred to our clinical
laboratories and be offered to our clients. We envision the CRO as a
way to infuse some intellectual property into the mix of our services and in
time create a more “vertically integrated” laboratory that can potentially offer
additional clinical services of a more proprietary nature.
As
NeoGenomics grows, we anticipate offering additional tests that broaden our
focus from genetic and molecular testing to more traditional types of anatomic
pathology testing that are complementary to our current test
offerings. At no time do we expect to intentionally compete with
fee-for-service pathologists for services of this type and Company sales efforts
will operate under a strict “right of first refusal” philosophy that supports
rather than undercuts the practice of community-based pathology. We
believe that by adding additional types of tests to our product offering we will
be able to capture increases in our testing volumes through our existing
customer base as well as more easily attract new customers via the ability to
package our testing services more appropriately to the needs of the
market.
Historically,
the above approach has borne out well for the Company. For most of FY
2004, the Company only performed one type of test in-house, cytogenetics, which
resulted in only one test being performed per customer requisition for most of
the year and an average revenue per requisition of approximately
$490. With the subsequent addition of FISH testing in FY 2005 and
flow cytometry to our pre-existing cytogenetics testing in FY 2006, our average
revenue/requisition increased by 35.6% in FY 2005 to approximately $632 and a
further 7% in FY 2006 to approximately $677/requisition. We believe
with focused sales and marketing efforts and the recent launch of GPS reporting,
NeoFISH tech-only FISH services, and the future addition of additional testing
platforms, the Company can continue to increase our average revenue per customer
requisition.
FY 2006
|
FY 2005
|
% Inc
(Dec)
|
||||||||||
Customer
Requisitions Rec’d (Cases)
|
9,563 | 2,982 | 220.7 | % | ||||||||
Number
of Tests Performed
|
12,838 | 4,082 | 214.5 | % | ||||||||
Average
Number of Tests/Requisition
|
1.34 | 1.37 | (2.1 | %) | ||||||||
Total
Testing Revenue
|
$ | 6,475,996 | $ | 1,885,324 | 243.5 | % | ||||||
Average
Revenue/Requisition
|
$ | 677.19 | $ | 632.23 | 7.1 | % | ||||||
Average
Revenue/Test
|
$ | 504.44 | $ | 461.86 | 9.2 | % |
We
believe this bundled approach to testing represents a clinically sound practice.
In addition, as the average number of tests performed per requisition increases,
this should drive large increases in our revenue and afford the Company
significant synergies and efficiencies in
6
our operations and sales and marketing activities. For instance, initial testing for many hematologic cancers may yield total revenue ranging from approximately $1,800 - $3,600/requisition and is generally comprised of a combination of some or all of the following tests: cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry and, per client request, morphology testing. Whereas in FY 2004, we only addressed approximately $500 of this potential revenue per requisition; in FY 2005 we addressed approximately $1,200 - $1,900 of this potential revenue per requisition; and in FY 2006, we could address this revenue stream (see below), dependent on medical necessity criteria and guidelines:
Average Revenue/Test
Cytogenetics | $ | 400-$500 | ||
Fluorescence In Situ Hybridization (FISH) | ||||
-Technical component | $ | 300-$1000 | ||
- Professional component | $ | 200-$500 | ||
Flow cytometry | ||||
- Technical component | $ | 400-$700 | ||
- Professional component | $ | 100-$200 | ||
Morphology | $ | 400-$700 | ||
Total | $ | 1,800-$3,600 | ||
Business
of NeoGenomics
Services
We
currently offer four primary types of testing services: cytogenetics,
flow cytometry, FISH testing and molecular testing.
Cytogenetics
Testing. Cytogenetics
testing involves analyzing chromosomes taken from the nucleus of cells and
looking for abnormalities in a process called karyotyping. A
karyotype evaluates the entire 46 human chromosomes by number and banding
patterns to identify abnormalities associated with disease. In
cytogenetics testing, we typically analyze the chromosomes of 20 different
cells. Examples of cytogenetics testing include bone marrow aspirate
or peripheral blood analysis to diagnose various types of leukemia and lymphoma,
and amniocentesis testing of pregnant women to diagnose genetic anomalies such
as Down syndrome in a fetus.
Cytogenetics
testing by large national reference laboratories and other competitors has
historically taken anywhere from 10-14 days on average to obtain a complete
diagnostic report. We believe that as a result of this timeframe,
many practitioners have refrained to some degree from ordering such tests
because the results traditionally were not returned within an acceptable
diagnostic window. NeoGenomics has designed our laboratory operations
in order to complete cytogenetics tests for most types of biological samples,
produce a final diagnostic report and make it available via fax or online
viewing within 3-5 days. These turnaround times are among the best in
the industry and we believe that, with further demonstration of our consistency
in generating results, more physicians will incorporate cytogenetics testing
into their diagnostic regimens and thus drive incremental growth in our
business.
Flow Cytometry
Testing. Flow cytometry
testing analyzes clusters of differentiation on cell surfaces. Gene
expression of many cancers creates protein-based clusters of differentiation on
the cell surfaces that can then be traced back to a specific lineage or type
of
7
cancer. Flow cytometry is a method of separating liquid specimens or disaggregated tissue into different constituent cell types. This methodology is used to determine which of these cell types is abnormal in a patient specific manner. Flow cytometry is important in developing an accurate diagnosis, defining the patient’s prognosis, and clarifying what treatment options may be optimal. Flow cytometry testing is performed using sophisticated lasers and will typically analyze over 100,000 individual cells in an automated fashion. Flow cytometry testing is highly complementary with cytogenetics and the combination of these two testing methodologies allows the results from one test to complement the findings of the other methodology, which can lead to a more accurate snapshot of a patient’s disease state.
FISH
Testing. As an adjunct to
traditional chromosome analysis, we offer Fluorescence In Situ Hybridization
(FISH) testing to extend our capabilities beyond routine
cytogenetics. FISH testing permits identification of the most
frequently occurring numerical chromosomal abnormalities in a rapid manner by
looking at specific genes that are implicated in cancer. FISH was
originally used as an additional staining methodology for metaphase analysis
(cells in a divided state after they have been cultured), but the technique is
now routinely applied to interphase analysis (non-dividing quiescent cells).
During the past 5 years, FISH testing has begun to demonstrate its considerable
diagnostic potential. The development of molecular probes by using DNA sequences
of differing sizes, complexity, and specificity, coupled with technological
enhancements (direct labeling, multicolor probes, computerized signal
amplification, and image analysis) make FISH a powerful investigative and
diagnostic tool.
Molecular
Testing. Molecular testing primarily involves the analysis
of DNA to screen for and diagnose single gene disorders such as
cystic fibrosis and Tay-Sachs disease as well as abnormalities in liquid and
solid tumors. There are approximately 1.0 – 2.0 million base pairs of
DNA in each of the estimated 25,000 genes located across the 46 chromosomes in
the nucleus of every cell. Molecular testing allows us to look for
variations in this DNA that are associated with specific types of
diseases. Today there are molecular tests for about 500 genetic
diseases. However, the majority of these tests remain available under
the limited research use only designation and are only offered on a restricted
basis to family members of someone who has been diagnosed with a genetic
condition. About 50 molecular tests are now available for the
diagnosis, prognosis or monitoring of various types of cancers and physicians
are becoming more comfortable ordering such adjunctive tests. We
currently provide these tests on an outsourced basis. We anticipate
in the near future performing some of the more popular tests within our
facilities as the number of requests continues to increase. Although
reimbursement rates for these new molecular tests still need to improve, we
believe that molecular testing is an important and growing market segment with
many new diagnostic tests being developed every year. We are
committed to providing the latest and most accurate testing to clients and we
will invest accordingly when market demand warrants.
Distribution
Methods
The
Company currently performs its testing services at each of its’ three main
clinical laboratory locations: Fort Myers, FL, Nashville, TN and Irvine, CA, and
then produces a report for the requesting physician. The Company
currently out sources all of its molecular testing to third parties, but expects
to validate some of this testing in-house during the next several years to meet
client demand.
Competition
We are
engaged in segments of the medical testing laboratory industry that are highly
competitive. Competitive factors in the genetic and molecular testing
business generally includereputation
of the laboratory, range of services offered, pricing, convenience of sample
collection and pick-up, quality of analysis and reporting and timeliness of
delivery of completed reports.
8
Our
competitors in the United States are numerous and include major medical testing
laboratories and biotechnology research companies. 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 genetics and molecular testing is
divided among approximately 300 laboratories. However, approximately 80% of
these laboratories are attached to academic institutions and only provide
clinical services to their affiliate university hospitals. We further believe
that less than 20 laboratories market their services nationally. We
believe that the industry as a whole is still quite fragmented, with the top 20
laboratories accounting for approximately 50% of market revenues.
We intend
to continue to gain market share by offering industry leading turnaround times,
a broad service menu, high-quality test reports, and enhanced post-test
consultation services. In addition, we have a fully integrated and
interactive virtual Laboratory Information System that enables us to report real
time results to customers in a secure environment.
Suppliers
The
Company orders its laboratory and research supplies from large national
laboratory supply companies such as Fisher Scientific, Inc., Invitrogen and
Beckman Coulter and does not believe any disruption from any one of these
suppliers would have a material effect on its 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 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 Abbott Laboratories has patent protection
which limits other vendors from supplying these probes.
Dependence on Major
Customers
We
currently market our services to pathologists, oncologists, urologists,
hospitals and other clinical laboratories. During 2006, we performed
12,838 individual tests. Ongoing sales efforts have decreased
dependence on any given source of revenue. Notwithstanding this fact,
several key customers still account for a disproportionately large case volume
and revenues. In 2005, four customers accounted for 65% of our total
revenue. For 2006, 3 customers represented 61% of our revenue with
each party representing greater than 15% of such revenues. However, as a result
of our rapid increase in revenues from other customers, these 3 customers only
represented 41% of our monthly revenue in December 2006. Given the
substantial increase in customers in the first quarter of 2007, we expect this
percentage to continue to decline. In the event that we lost one of
these customers, we would potentially lose a significant percentage of our
revenues.
9
Trademarks
The
“NeoGenomics” name and logo has been trademarked with the United States Patent
and Trademark Office.
Number of
Employees
As of
December 31, 2006, we had 48 full-time employees. In addition, our
Acting Principal Financial Officer and a pathologist serve as consultants to the
Company on a part-time basis. On December 31, 2005, we had 23
employees. Our employees are not represented by any union and we believe our
employee relations are good.
Government
Regulation
Our
business is subject to government regulation at the federal, state and local
levels, some of which regulations are described under "Clinical Laboratory
Operations," "Anti-Fraud and Abuse Laws," “The False Claims Act,”
"Confidentiality of Health Information," and "Food and Drug
Administration" below.
Clinical Laboratory
Operations
Genetics and Molecular
Testing. The Company operates clinical laboratories in Fort
Myers, FL, Nashville, TN, and Irvine, CA. All locations have obtained
CLIA certification under the federal Medicare program, the Clinical Laboratories
Improvement Act of 1967 and the Clinical Laboratory Amendments of 1988
(collectively “CLIA ‘88”) as well as state licensure as required in FL, TN, and
CA. CLIA ‘88 provides
for the regulation of clinical laboratories by the U.S. Department of Health and
Human Services (“HHS”). Regulations promulgated under the federal Medicare
guidelines, CLIA ’88 and the clinical laboratory licensure laws of the various
states affect our genetics laboratories.
The
federal and state certification and licensure programs establish standards for
the operation of clinical laboratories, including, but not limited to, personnel
and quality control. Compliance with such standards is verified by periodic
inspections by inspectors employed by federal or state regulatory agencies. In
addition, federal regulatory authorities require participation in a proficiency
testing program approved by HHS for many of the specialties and subspecialties
for which a clinical laboratory seeks approval from Medicare or Medicaid and
certification under CLIA `88. Proficiency testing programs involve actual
testing of specimens that have been prepared by an entity running an approved
program for testing by a clinical laboratory.
A
final rule implementing CLIA `88, published by HHS on February 28, 1992, became
effective September 1, 1992. This rule has been revised on several occasions and
further revision is expected. The CLIA `88 rule applies to virtually all
clinical laboratories in the United States, including our clinical laboratory
locations. We have reviewed our operations as they relate to CLIA
`88, including, among other things, the CLIA `88 rule's requirements regarding
clinical laboratory administration, participation in proficiency testing,
patient test management, quality control, quality assurance and personnel for
the types of testing we undertake, and believe that all of our clinical
laboratory locations are in compliance with these requirements. Our
clinical laboratory locations may not pass inspections conducted to ensure
compliance with CLIA `88 or with any other applicable licensure or certification
laws. The sanctions for failure to comply with CLIA `88 or state licensure
requirements might include the inability to perform services for compensation or
the suspension, revocation or limitation of any clinical laboratory locations,
CLIA `88 certificate or state license, as well as civil and/or criminal
penalties.
10
Regulation of Genetic Testing.
In 2000, the Secretary of Health and Human Services Advisory Committee on
Genetic Testing published recommendations for increased oversight by the Centers
for Disease Control and the FDA for all genetic testing. This committee
continues to meet and discuss potential regulatory changes, but final
recommendations have not been issued.
With
respect to genetic therapies, which may become part of our business in the
future, in addition to FDA requirements, the National Institutes of Health
(“NIH”) has established guidelines providing that transfers of recombinant DNA
into human subjects at NIH laboratories or with NIH funds must be approved by
the NIH Director. The NIH has established the Recombinant DNA Advisory Committee
to review gene therapy protocols. Although we do not currently offer
any gene therapy services, if we decide to enter this business in the future, we
would expect that all of our gene therapy protocols will be subject to review by
the Recombinant DNA Advisory Committee.
Anti-Fraud
and Abuse Laws
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. One
provision of these laws, known as the "anti-kickback law," contains extremely
broad proscriptions. Violation of this provision may result in criminal
penalties, exclusion from participation in Medicare and Medicaid programs, and
significant civil monetary penalties.
In January 1990, following a study of
pricing practices in the clinical laboratory industry, the Office of the
Inspector General ("OIG") of HHS issued a report addressing how these pricing
practices relate to Medicare and Medicaid. The OIG reviewed the industry's use
of one fee schedule for physicians and other professional accounts and another
fee schedule for patients/third-party payers, including Medicare, in billing for
testing services, and focused specifically on the pricing differential when
profiles (or established groups of tests) are ordered.
Existing
federal law authorizes the Secretary of HHS to exclude providers from
participation in the Medicare and Medicaid programs if they charge state
Medicaid programs or Medicare fees "substantially in excess" of their "usual and
customary charges." On September 2, 1998, the OIG issued a final rule in which
it indicated that this provision has limited applicability to services for which
Medicare pays under a Prospective Payment System or a fee schedule, such as
anatomic pathology services and clinical laboratory services. 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 a 1999 Advisory
Opinion 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. The Medicaid laws in some states also have prohibitions
related to discriminatory pricing.
Under
another federal law, known as the "Stark" law or "self-referral prohibition,"
physicians who have an investment or compensation relationship with an entity
furnishing clinical laboratory services (including anatomic pathology and
clinical chemistry services) may not, subject to certain exceptions, refer
clinical laboratory testing for Medicare patients to that entity.
Similarly, laboratories may not bill Medicare or Medicaid or any other party for
services furnished pursuant to a prohibited referral. Violation of these
provisions may result in disallowance of Medicare and Medicaid claims for the
affected testing services, as well as the imposition of civil monetary penalties
and application of False Claims submissions penalties. Some states also have
laws similar to the Stark law.
11
The
False Claims Act
The
Civil False Claims Act enacted in 1864, pertains to any federally
funded program and defines “Fraudulent” as: knowingly submitting a
false claim, i.e. actual knowledge of the falsity of the claim, reckless
disregard or deliberate ignorance of the falsity of the claim. These are the
claims to which criminal penalties are applied. Penalties include permissive
exclusion in federally funded programs by Center for Medicare Services (“CMS”)
as well as $11,500 plus treble damages per false claim submitted, and can
include imprisonment. High risk areas include but are not limited to
accurate use and selection of CPT codes, ICD-9 codes provided by the ordering
physician, billing calculations, performance and billing of reported testing,
use of reflex testing, and accuracy of charges at fair market
value.
We
will seek to structure our arrangements with physicians and other customers to
be in compliance with the Anti-Kickback Statute, Stark Law, State laws, and the
Civil False Claims Act 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 could become
subject to scrutiny there under.
In
February 1997 (as revised in August 1998), the OIG released a model compliance
plan for laboratories that is based largely on corporate integrity agreements
negotiated with laboratories that had settled enforcement action brought by the
federal government related to allegations of submitting false
claims. We believe that we comply with the aspects of the model plan
that we deem appropriate to the conduct of our business.
Confidentiality
of Health Information
The
Health Insurance Portability and Accountability Act of 1996 ("HIPAA") contains
provisions that affect the handling of claims and other patient information that
are, or have been used or disclosed by healthcare providers. These provisions,
which address security and confidentiality of PHI (Protected Health Information
or “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. Rules
implementing various aspects of HIPAA are continuing to be
developed.
The HIPAA
Rules include the following components which have already been implemented at
our locations and industry wide: The Privacy Rule which granted patients rights
regarding their information also pertains to the proper uses and disclosures of
PHI by healthcare providers in written and verbal formats required
implementation no later than April 14, 2003 for all covered entities except
small health plans which had another year for implementation. The Electronic
Health Care Transactions and Code Sets Standards which established standard data
content and formats for submitting electronic claims and other administrative
healthcare transactions required implementation no later than October 16, 2003
for all covered entities. On April 20, 2005, CMS required compliance with the
Security Standards which established standards for electronic uses and
disclosures of PHI for all covered entities except small health plans who had an
additional year to meet compliance. Currently, the industry, including all of
our locations,
is working to comply with the National Provider Identification number to replace
all previously issued provider (organizational and individual) identification
numbers. This number is being issued by CMS and must be used on all covered
transactions no later than May 23, 2007 by all covered entities except small
health plans which have an additional year to meet compliance with this
rule.
12
In
addition to the HIPAA rules described above, we are subject to state laws
regarding the handling and disclosure of patient records and patient health
information. These laws vary widely, and many states are passing new laws in
this area. Penalties for violation include sanctions against a laboratory's
licensure as well as civil or criminal penalties. We believe we are
in compliance with current state law regarding the confidentiality of health
information and continue to keep abreast of new or changing state laws as they
become available.
Food
and Drug Administration
In
January 1998, the FDA issued a revised draft Compliance Policy Guide ("CPG")
that sets forth FDA's intent to undertake a heightened enforcement effort with
respect to the improper Commercialization of In Vitro Diagnostic Devices prior
to receipt of FDA premarket clearance or approval. September, 2006, the FDA
issued the Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on
In Vitro Diagnostic
Multivariate Index Assays (IVDMIAs) as a current initiative of the FDA to
regulate test systems that employ data, derived in part from one or more in
vitro assays, and an algorithm that usually, but not necessarily, runs on
software to generate a result that diagnoses a disease or condition or is used
in the cure, mitigation, treatment, or prevention of disease. In the future, we
plan to perform some testing services using test kits purchased from
manufacturers for which FDA premarket clearance or approval for commercial
distribution in the United States has not been obtained by the manufacturers
("investigational test kits"). Under current FDA regulations and policies, such
investigational test kits may be sold by manufacturers for investigational use
only if certain requirements are met to prevent commercial distribution. The
manufacturers of these investigational test kits are responsible for marketing
them under conditions meeting applicable FDA requirements. That draft CPG as
well as the current Draft Guidance on IVDMIAs is not presently in effect but, if
implemented as written, would place greater restrictions on the distribution of
such investigational test kits or devices. If we were to be
substantially limited in or prevented from purchasing investigational test kits
or devices by reason of the FDA finalizing these guidelines, there could be an
adverse effect on our ability to access new technology, which could have a
material adverse effect on our business.
We also
perform some testing services using reagents, known as analyte specific reagents
("ASRs"), purchased from companies in bulk rather than as part of a test
kit. In November 1997, the FDA issued a new regulation placing
restrictions on the sale, distribution, labeling and use of
ASRs. Most ASRs are treated by the FDA as low risk devices, requiring
the manufacturer to register with the agency, its ASRs (and any other devices),
conform to good manufacturing practice requirements, and comply with medical
device reporting of adverse events.
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
13
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.
We
Have A Limited Operating History Upon Which You Can Evaluate Our
Business
The
Company commenced revenue operations in 2002 and is just beginning to generate
meaningful revenue. Accordingly, the Company has a limited operating
history upon which an evaluation of the Company and its prospects can be
based. The Company and its prospects must be considered in light of
the risks, expenses and difficulties frequently encountered by companies in the
rapidly evolving market for healthcare and medical laboratory
services. To address these risks, the Company must, among other
things, respond to competitive developments, attract, retain and motivate
qualified personnel, implement and successfully execute its sales strategy,
develop and market additional services, and upgrade its technological and
physical infrastructure in order to scale its revenues. The Company
may not be successful in addressing such risks. The limited operating
history of the Company makes the prediction of future results of operations
difficult or impossible.
We
May Not Be Able To Implement The Company’s Business Strategies Which Could
Impair Our Ability to Continue Operations
Implementation
of the Company’s business strategies will depend in large part on the Company’s
ability to (i) attract and maintain a significant number of customers; (ii)
effectively provide acceptable products and services to the Company’s customers;
(iii) obtain adequate financing on favorable terms to fund the Company’s
business strategies; (iv) maintain appropriate procedures, policies, and
systems; (v) hire, train, and retain skilled employees; (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 payers. The Company’s inability to obtain or maintain any or
all these factors could impair its ability to implement its business strategies
successfully, which could have material adverse effects on its results of
operations and financial condition.
We
May Be Unsuccessful In Managing Our Growth Which Could Prevent the Company From
Becoming Profitable
The
Company’s recent growth has placed, and is expected to continue to place, a
significant strain on its managerial, operational and financial
resources. To manage its potential growth, the Company must continue
to implement and improve its operational and financial systems and to expand,
train and manage its employee base. The Company may not be able to
effectively manage the expansion of its operations and the Company’s systems,
procedures or controls may not be adequate to support the Company’s
operations. The Company’s management may not be able to achieve the
rapid execution necessary to fully exploit the market opportunity for the
Company’s products and services. Any inability to manage growth could
have a material adverse effect on the Company’s business, results of operations,
potential profitability and financial condition.
Part
of the Company’s business strategy may be to acquire assets or other companies
that will complement the Company’s existing business. The Company is unable to
predict whether or when any material transaction will be completed should
negotiations commence. If the Company proceeds with any such
transaction, the Company may not effectively integrate the acquired operations
with the Company’s own operations. The Company 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.
14
We
May Incur Greater Costs Than Anticipated, Which Could Result in Sustained
Losses
The
Company used reasonable efforts to assess and predict the expenses necessary to
pursue its business plan. However, implementing the Company’s 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 the Company estimates, which could result in sustained
losses.
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 the Company’s limited operating history and the relatively limited
information available on the Company’s competitors, the Company may not have
sufficient internal or industry-based historical financial data upon which to
calculate anticipated operating expenses. Management expects that the
Company’s 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 the Company’s products and
services; (ii) demand for the Company’s products and services; (iii) the
introduction and acceptance of new or enhanced products or services by us or by
competitors; (iv) the Company’s ability to anticipate and effectively adapt to
developing markets and to rapidly changing technologies; (v) the Company’s
ability to attract, retain and motivate qualified personnel; (vi) the
initiation, renewal or expiration of significant contracts with the Company’s
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. The Company’s expenses are based in part on
the Company’s expectations as to future revenues and to a significant extent are
relatively fixed, at least in the short-term. The Company 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 the Company’s expectations would have an immediate adverse impact on the
Company’s business, results of operations and financial condition. In
addition, the Company may determine from time to time to make certain pricing or
marketing decisions or acquisitions that could have a short-term material
adverse effect on the Company’s business, results of operations and financial
condition and may not result in the long-term benefits
intended. Furthermore, in Florida, currently a primary referral
market for our lab testing services, a meaningful percentage of the population
returns to homes in the Northern U.S. to avoid the hot summer
months. This may result in seasonality in our
business. Because of all of the foregoing factors, the
Company’s 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 payers, including but not limited to Medicare, Medicaid and various
insurance companies, in order to get paid for performing services
on
15
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 affect 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. The Company’s
future success will depend in significant part on its ability to continually
improve its offerings in response to both evolving demands of the marketplace
and competitive service offerings, and the Company may be unsuccessful in doing
so.
The
Market For Our Services Is Highly Competitive, Which Could Have A Material
Adverse Affect On Our Business, Results Of Operations And Financial
Condition
The
market for genetic and molecular testing services is highly competitive and
competition is expected to continue to increase. The Company competes
with other commercial medical laboratories in addition to the in-house
laboratories of many major hospitals. Many of the Company’s existing
competitors have significantly greater financial, human, technical and marketing
resources than the Company. The Company’s competitors may develop
products and services that are superior to those of the Company or that achieve
greater market acceptance than the Company’s offerings. The Company
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 the
Company’s 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 customers 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 customers
and cases increases, the Company’s products, services, and infrastructure may
not be able to scale accordingly. Any failure to handle higher volume
of requests for the Company’s products and services could lead to the loss of
established customers and have a material adverse effect on the Company’s
business, results of operations and
financial condition.
16
If
we produce inaccurate test results, our customers 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 the
Company.
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,
power loss, telecommunications failures, break-ins and similar
events. The Company does not presently have an emergency back-up
generator in place at its Fort Myers, Fl, Nashville, TN and Irvine, CA
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 Customers, which could have a
material adverse effect on the Company’s business, results of operations and
financial condition.
The
Steps Taken By The Company To Protect Its Proprietary Rights May Not Be
Adequate
The
Company regards its copyrights, trademarks, trade secrets and similar
intellectual property as critical to its success, and the Company relies upon
trademark and copyright law, trade secret protection and confidentiality and/or
license agreements with its employees, customers, partners and others to protect
its proprietary rights. The steps taken by the Company to protect its
proprietary rights may not be adequate or third parties may infringe or
misappropriate the Company’s copyrights, trademarks, trade secrets and similar
proprietary rights. In addition, other parties may assert
infringement claims against the Company.
We
are Dependent on Key Personnel and Need to Hire Additional Qualified
Personnel
The
Company’s performance is substantially dependent on the performance of its
senior management and key technical personnel. In particular, the
Company’s success depends substantially on the continued efforts of its senior
management team, which currently is composed of a small number of
individuals. The loss of the services of any of its executive
officers, its laboratory director or other key employees could have a material
adverse effect on the business, results of operations and financial condition of
the Company.
The
Company’s future success also depends on its continuing ability to attract and
retain highly qualified technical and managerial
personnel. Competition for such personnel is intense and the Company
may not be able to retain its 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 the Company’s business, results of operations and financial
condition.
The
Failure to Obtain Necessary Additional Capital to Finance Growth and Capital
Requirements, Could Adversely Affect The Company’s Business, Financial Condition
and Results of Operations
17
The
Company may seek to exploit business opportunities that require more capital
than what is currently planned. The Company may not be able to
raise such capital on favorable terms or at all. If the Company is
unable to obtain such additional capital, the Company may be required to reduce
the scope of its anticipated expansion, which could adversely affect the
Company’s business, financial condition and results of operations.
Our
Net Revenue will be Diminished If Payers 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 payers, including governmental payers such as Medicare and
private payers, 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 assays or assays we discover and develop. However, a substantial
portion of the testing for which we bill our hospital and laboratory clients is
ultimately paid by third party payers. Any pricing pressure exerted by these
third party payers on our customers may, in turn, be exerted by our customers on
us. If government and other third party payers do not provide adequate coverage
and reimbursement for our assays, 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 payer is the party
that pays for the tests, and the two are not always the same. Depending on the
billing arrangement and applicable law, we need to bill various payers, such as
patients, insurance companies, Medicare, Medicaid, doctors and employer groups,
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. This adds further complexity to the billing process.
Among many other factors complicating
billing are:
•
|
pricing
differences between our fee schedules and the reimbursement rates of
the payers;
|
• disputes
with payers 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 customers;
(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.
18
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, as a large number of
laboratories have been forced by the federal and state governments, as well as
by private payers, 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 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 providers and suppliers.
Those provisions allow a private individual to bring actions 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 to become the primary prosecutor. If it declines to
do so, the individual may choose to 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. Written “corporate compliance” programs to actively
monitor compliance with fraud laws and other regulatory requirements are
recommended by the Department of Health and Human Services’ Office of the
Inspector General.
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, the
Company is subject to extensive state and federal regulatory
oversight. Our laboratory locations may not pass inspections
conducted to ensure compliance with CLIA `88 or with any other applicable
licensure or certification laws. The sanctions for failure to comply with CLIA
`88 or state licensure requirements might include the inability to perform
services for compensation or the suspension, revocation or limitation of the a
laboratory location’s CLIA `88 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 will seek to structure our
arrangements with physicians and other customers 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.
19
Furthermore,
the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and
other state laws contains 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.
We
Are Subject to Security Risks Which Could Harm Our Operations
Despite
the implementation of various security measures by the Company, the Company’s
infrastructure is vulnerable to computer viruses, break-ins and similar
disruptive problems caused by its customers or others. Computer
viruses, break-ins or other security problems could lead to interruption, delays
or cessation in service to the Company’s customers. Further, such
break-ins whether electronic or physical could also potentially jeopardize the
security of confidential information stored in the computer systems of the
Company’s customers and other parties connected through the Company, which may
deter potential customers and give rise to uncertain liability to parties whose
security or privacy has been infringed. A significant security breach
could result in loss of customers, damage to the Company’s 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 the Company’s business, results of operations and financial
condition.
The
Company Is Controlled by Existing Shareholders And Therefore Other Shareholders
Will Not Be Able to Direct The Company
The
majority of the Company’s shares and thus voting control of the Company is held
by a relatively small group of shareholders. Because of such
ownership, those shareholders will effectively retain control of the Company’s
Board of Directors and determine all of the Company’s corporate
actions. In addition, the Company and shareholders owning 13,106,579
shares, or approximately 47.3% of the Company’s voting shares outstanding as of
March 29, 2007 have executed a Shareholders’ Agreement that, among other
provisions, gives Aspen Select Healthcare, LP, our largest shareholder, the
right to elect three out of the seven directors authorized for our Board, and
nominate one mutually acceptable independent director. Accordingly,
it is anticipated that Aspen Select Healthcare, LP and other parties to the
Shareholders’ Agreement will continue to have the ability to elect a controlling
number of the members of the Company’s Board of Directors and the minority
shareholders of the Company may not be able to elect a representative to the
Company’s 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
The
Company does not anticipate paying dividends on its common shares in the
foreseeable future. Rather, the Company plans to retain earnings, if
any, for the operation and expansion of Company business.
20
There
Is No Guarantee of Registration Exemption for Sales of Unregistered Stock, Which
Could Result in the Liquidation of the Company
From
time to time, the Company sells shares of unregistered stock in various private
placements to accredited investors. These sales are generally made in
reliance upon the "private placement" exemption from registration provided by
Section 4(2) of the Securities Act of 1933, as amended, and Rule 506 of
Regulation D promulgated pursuant thereto. Reliance on this exemption
does not, however, constitute a representation or guarantee that such exemption
is indeed available.
If
for any reason any future sales of unregistered stock are deemed to be a public
offering of the Company’s shares (and if no other exemption from registration is
available), the sale of the offered shares would be deemed to have been made in
violation of the applicable laws requiring registration of the offered shares
and the delivery of a prospectus. As a remedy in the event of such
violation, each purchaser of the offered shares would have the right to rescind
his or her purchase of the offered shares and to have his or her purchase price
returned. If such a purchaser requests a return of his or her
purchase price, funds might not be available for that purpose. In
that event, liquidation of the Company might be required. Any refunds
made would reduce funds available for the Company’s working capital
needs. A significant number of requests for rescission would probably
cause the Company to be without funds sufficient to respond to such requests or
to proceed with the Company’s activities successfully.
ITEM
2. DESCRIPTION
OF PROPERTY
In
August 2003, we entered into a three year lease for 5,200 square feet at our
laboratory facility in Fort Myers, Florida. On June 29, 2006 we
signed an amendment to the original lease which extended the lease through June
30, 2011. The amendment included the rental of an additional 4,400
square feet adjacent to our current facility. This space will
allow for future expansion of our business. The lease was further amended on
January 17, 2007 but this amendment did not materially alter the terms of the
lease, which has total payments of approximately $653,000 over the remaining
life of the lease, including annual increases of rental payments of 3% per
year. Such amount excludes estimated operating and maintenance
expenses and property taxes.
As
part of the acquisition of The Center for CytoGenetics, Inc. by the Company on
April 18, 2006, we assumed the lease of an 850 square foot facility in
Nashville, Tennessee. The lease expires on August 31,
2008. The average monthly rental expense is approximately $1,350 per
month. This space was not adequate for our future plans and the
Company is currently not using the facility and is actively trying to sublease
this facility. On June 15, 2006, we entered into a lease for a new
facility totaling 5,386 square feet of laboratory space in Nashville, Tennessee.
This space will be adequate to accommodate our current plans for the Tennessee
laboratory. As part of the lease, we have the right of first refusal on an
additional 2,420 square feet, if needed, directly adjacent to the
facility. The lease is a five year lease and results in total
payments by us of approximately $340,000.
On
August 1, 2006, the Company entered into a lease for 1,800 square feet of
laboratory space in Irvine, California. The lease is a nine month lease and
results in total payments by the Company of approximately
$23,000. This lease will expire on April 30, 2007. We are currently
in negotiations on a new larger facility, which can accommodate our future
growth.
21
ITEM
3.
|
LEGAL
PROCEEDINGS
|
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 (the “Court”) against the
Company and Robert Gasparini, as an individual, and certain other employees and
non-employees of NeoGenomics with respect to claims arising from discussions
with current and former employees of US Labs. US Labs alleges, among
other things, that NeoGenomics engaged in “unfair competition” by having access
to certain salary information of four recently hired sales personnel prior to
the time we hired such individuals. We believe that US Labs’ claims
against NeoGenomics lack any merit and that there are well-established laws that
affirm the rights of employees to seek employment with any company they desire
and employers to offer such employment to anyone they desire. US Labs
seeks unspecified monetary relief. As part of the complaint, US Labs
also sought preliminary injunctive relief against NeoGenomics and requested that
the Court bar NeoGenomics from, among other things: a) inducing any
further US Labs’ employees to resign employment with US Labs, b) soliciting,
interviewing or employing US Labs’ employees for employment, c) directly or
indirectly soliciting US Labs’ customers with whom four new employees of
NeoGenomics did business while employed at US Labs; and d) soliciting,
initiating and/or maintaining economic relationships with US Labs’ customers
that are under contract with US Labs.
On November 15, 2006, the Court
heard arguments on US Labs request for a preliminary injunction and denied the
majority of US Labs’ requests for such injunction on the grounds that US Labs
was not likely to prevail at trial. The Court did, however, issue a
much narrower preliminary injunction which prevents NeoGenomics from
“soliciting” the US Labs’ customers of such new sales personnel until such time
as a full trial could be held. This preliminary injunction is limited
only to the “solicitation” of the US Labs’ customers of the sales personnel in
question and does not in any way prohibit NeoGenomics from doing business with
any such customers to the extent they have sought or seek a business
relationship with NeoGenomics on their own initiative. Furthermore,
NeoGenomics is not in any way prohibited from recruiting any additional
personnel from US Labs through any lawful means. We believe that none
of US Labs’ claims will be affirmed at trial; however, even if they were,
NeoGenomics does not believe such claims would result in a material impact to
our business. NeoGenomics further believes that this lawsuit is
nothing more than a blatant attempt by a large corporation to impede the
progress of a smaller and more nimble competitor, and we intend to vigorously
defend ourselves.
Discovery
commenced in December 2006. While the Company received unsolicited
and inaccurate salary information for three individuals that were ultimately
hired, no evidence of misappropriation of trade secrets has been discovered by
either side. As such, the Company is currently contemplating filing
motions to narrow or end the litigation, and expects to ultimately prevail at
trial.
The Company is also a defendant
in one lawsuit from a former employee relating to compensation related
claims. The Company does not believe this lawsuit is material to its
operations or financial results and intends to vigorously pursue its defense of
the matter.
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not
applicable.
22
PART
II
ITEM
5.
|
MARKET
FOR THE COMPANY’S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
|
Our
common stock is quoted on the OTC Bulletin Board. Set forth below is
a table summarizing the high and low bid quotations for our common stock during
the last two fiscal years.
QUARTER
|
HIGH BID
|
LOW BID
|
||||||
4th
Quarter 2006
|
$ | 2.05 | $ | 0.94 | ||||
3rd
Quarter 2006
|
$ | 1.25 | $ | 0.60 | ||||
2nd
Quarter 2006
|
$ | 0.78 | $ | 0.45 | ||||
1st
Quarter 2006
|
$ | 0.72 | $ | 0.12 | ||||
4th
Quarter 2005
|
$ | 0.35 | $ | 0.18 | ||||
3rd
Quarter 2005
|
$ | 0.59 | $ | 0.24 | ||||
2nd
Quarter 2005
|
$ | 0.60 | $ | 0.26 | ||||
1st
Quarter 2005
|
$ | 0.70 | $ | 0.25 |
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 represent actual transactions. All historical data was obtained
from the www.BigCharts.com web site.
As of
March 29, 2007 there were 388 stockholders of record of our common stock,
excluding shareholders who hold their shares in brokerage accounts in “street
name”. 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 we do not anticipate paying any cash dividends in the
foreseeable future.
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 of 1933, as amended, as a "transaction not involving a public
offering." No commissions were paid, and no underwriter participated, in
connection with any of these transactions. Each such issuance was made pursuant
to individual contracts which are discrete from one another and are made only
with persons who were sophisticated in such transactions and who had knowledge
of and access to sufficient information about the Company to make an informed
investment decision. Among this information was the fact that the securities
were restricted securities.
During
2004, we sold 3,040,000 shares of our common stock in a series of private
placements at $0.25/share to unaffiliated third party investors. These
transactions generated net proceeds to the Company of approximately $740,000
after deducting certain transaction expenses. These transactions
involved the issuance of unregistered stock to accredited investors in
transactions that we believed were exempt from registration under Rule 506
promulgated under the Securities Act of 1933. All of these shares
were subsequently registered on a SB-2 Registration Statement, which was
declared effective by the SEC on August 1, 2005.
23
During
the period January 1, 2005 to May 31, 2005, we sold 450,953 shares of our common
stock in a series of private placements at $0.30 - $0.35/share to unaffiliated
third party investors. These transactions generated net proceeds to the Company
of approximately $146,000. These transactions involved the issuance
of unregistered stock to accredited investors in transactions that we believed
were exempt from registration under Rule 506 promulgated under the Securities
Act of 1933. All of these shares were subsequently registered on a
SB-2 Registration Statement, which was declared effective by the SEC on August
1, 2005.
On February 18, 2005, we entered into a
binding agreement with Aspen Select Healthcare, LP (formerly known as MVP 3, LP)
(“Aspen”) to refinance our
existing indebtedness of $740,000 and provide for additional liquidity of up to
$760,000 to the Company pursuant to a new credit facility (the “Credit
Facility”). As part of this agreement, we also agreed to issue
to Aspen a five year Warrant to purchase up to 2,500,000 shares of its common
stock at an original exercise price of $0.50/share. Steven C. Jones, our
Acting Principal Financial Officer and a Director of the Company, is a managing
member of the general partner of Aspen. An amended and restated Loan Agreement
for the Credit Facility and other ancillary documents, including the warrant
agreement, which more formally implemented the agreements made on February 18,
2005 were executed on March 23, 2005. All material terms were
identical to the February 18, 2005 agreement.
On June 6, 2005, we entered into a
Standby Equity Distribution Agreement (“SEDA”) with Cornell Capital Partners, LP
(“Cornell”). Pursuant to the Standby Equity Distribution Agreement,
the Company may, at its discretion, periodically sell to Cornell shares of
common stock for a total purchase price of up to $5.0 million. Upon
execution of the Standby Equity Distribution Agreement, Cornell received 381,888
shares of the Company’s common stock as a commitment fee under the Standby
Equity Distribution Agreement. The Company also issued 27,278 shares
of the Company’s common stock to Spartan Securities Group, Ltd. under a
placement agent agreement relating to the Standby Equity Distribution
Agreement.
On
January 18, 2006, the Company entered into a binding letter agreement (the
"Aspen Agreement") with Aspen Select Healthcare, LP, which provided, among other
things, that:
(a) Aspen
waived certain pre-emptive rights in connection with the sale of $400,000 of
common stock at a purchase price of $0.20/share and the granting of 900,000
warrants with an exercise price of $0.26/share to SKL Limited Partnership, LP
("SKL" as more fully described below) in exchange for five year warrants to
purchase 150,000 shares at an exercise price of $0.26/share (the “Waiver
Warrants”).
(b) Aspen
had the right, up to April 30, 2006, to purchase up to $200,000 of restricted
shares of the Company's common stock at a purchase price per share of
$0.20/share (1,000,000 shares) and receive a five year warrant to purchase
450,000 shares of the Company's common stock at an exercise price of $0.26/share
in connection with such purchase (the "Equity Purchase Rights"). On March 14,
2006, Aspen exercised its Equity Purchase Rights.
(c) Aspen
and the Company amended the Loan Agreement, dated March 23, 2005 (the "Loan
Agreement") between the parties to extend the maturity date until September 30,
2007 and to modify certain covenants (such Loan Agreement as amended, the
"Credit Facility Amendment").
(d)
Aspen had the right, until April 30, 2006, to provide up to $200,000 of
additional secured indebtedness to the Company under the Credit Facility
Amendment and to
24
receive a
five year warrant to purchase up to 450,000 shares of the Company's common stock
with an exercise price of $0.26/share (the "New Debt Rights").On March 30, 2006,
Aspen exercised its New Debt Rights and entered into the definitive transaction
documentation for the Credit Facility Amendment and other such documents
required under the Aspen Agreement.
(e) The
Company agreed to amend and restate the warrant agreement, dated March 23, 2005,
to provide that all 2,500,000 warrant shares (the "Existing Warrants") were
vested and the exercise price per share was reset to $0.31 per
share.
(f) The
Company agreed to amend the Registration Rights Agreement, dated March 23, 2005
(the "Registration Rights Agreement"), between the parties to incorporate the
Existing Warrants, the Waiver Warrants and any new shares or warrants issued to
Aspen in connection with the Equity Purchase Rights or the New Debt
Rights.
During the period from January 18 - 21,
2006, the Company entered into agreements with four other shareholders who are
parties to a Shareholders’ Agreement, dated March 23, 2005, to exchange five
year warrants to purchase an aggregate of 150,000 shares of stock at an exercise
price of $0.26/share for such shareholders’ waiver of their pre-emptive rights
under the Shareholders’ Agreement.
On January 21, 2006 the Company entered
into a subscription agreement (the "Subscription") with SKL Family Limited
Partnership, LP, a New Jersey limited partnership, whereby SKL purchased 2.0
million shares (the "Subscription Shares") of the Company's common stock at a
purchase price of $0.20/share for $400,000. Under the terms of the Subscription,
the Subscription Shares are restricted for a period of 24 months and then carry
piggyback registration rights to the extent that exemptions under Rule 144 are
not available to SKL. In connection with the Subscription, the Company also
issued a five year warrant to purchase 900,000 shares of the Company's common
stock at an exercise price of $0.26/share. SKL has no previous
affiliation with the Company.
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
|
|||||||||
Equity
compensation plans approved by security holders
|
2,107,000 | $ | 0.43 | 1,390,841 | ||||||||
Equity
compensation plans not approved by security holders
|
N/A | N/A | N/A | |||||||||
Total
|
2,107,000 | $ | 0.43 | 1,390,841 |
(a) As
of December 31, 2006. Currently, the Company’s Equity Incentive Plan,
as amended and restated on October 31, 2006 is the only equity compensation plan
in effect. The Company’s Employee Stock Purchase Plan, dated October
31, 2006 started on January 1, 2007.
25
ITEM
6.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OR PLAN OF
OPERATION
|
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 the Company’s or 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. For a
discussion on forward-looking statements, see the information set forth in the
Introductory Note to this Annual Report under the caption “Forward Looking
Statements”, which information is incorporated herein by reference.
Overview
NeoGenomics
operates cancer-focused testing laboratories that specifically target the
rapidly growing genetic and molecular testing segment of the medical laboratory
industry. We currently operate in three laboratory locations: Fort
Myers, Florida, Nashville, Tennessee and Irvine, California. We
currently offer throughout the United States the following types of testing
services to oncologists, pathologists, urologists, hospitals, and other
laboratories: a) cytogenetics testing, which analyzes human
chromosomes, b) Fluorescence In-Situ Hybridization (FISH) testing, which
analyzes abnormalities at the chromosome and gene levels, c) flow cytometry
testing services, which analyzes gene expression of specific markers inside
cells and on cell surfaces, d) morphological testing, which analyzes cellular
structures and e) molecular testing which involves, analysis of DNA and RNA and
predict the clinical significance of various genetic sequence
disorders. All of these testing services are widely used in the
diagnosis and prognosis of various types of cancer.
Our
common stock is listed on the NASDAQ Over-the-Counter Bulletin Board (the
“OTCBB”) under the symbol “NGNM.”
The
genetic and molecular testing segment of the medical laboratory industry is the
most rapidly growing segment of the medical laboratory
market. Approximately six years ago, the World Health Organization
reclassified cancers as being genetic anomalies. This growing
awareness of the genetic root behind most cancers combined with advances in
technology and genetic research, including the complete sequencing of the human
genome, have made possible a whole new set of tools to diagnose and treat
diseases. This has opened up a vast opportunity for laboratory
companies that are positioned to address this growing market
segment.
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.
26
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
Net
revenues are recognized in the period when tests are performed and consist
primarily of net patient revenues that are recorded based on established billing
rates less estimated discounts and contractual allowances principally for
patients covered by Medicare, Medicaid and managed care and other health
plans. Adjustments of the estimated discounts are recorded in the
period payment is received. These revenues also are subject to review and
possible audit by the payers. We believe that adequate provision has
been made for any adjustments that may result from final determination of
amounts earned under all the above arrangements. There are no known
material claims, disputes or unsettled matters with any payers that are not
adequately provided for in the accompanying consolidated financial
statements.
Accounts
Receivable
We
record accounts receivable net of estimated discounts, contractual allowances,
and allowances for bad debt. 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 2006, we recorded
approximately $55,000 of net total incremental revenue from tests in which we
underestimated the revenue in 2005 relative to the amounts that we were
ultimately paid in 2006. This was less than 1% of our total FY 2006
revenue and less than 3% of our FY 2005 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 for future periods as accurate as possible based on our most
recent collection experience with each third party payer.
27
The
following table presents the dollars and percentage of the Company’s net
accounts receivable from customers outstanding by aging category at December 31,
2006 and 2005. All of our receivables were pending approval by third
party payers as of the date the receivables were recorded.
FY
2006
|
||||||||||||||||||||||||||||||||||||||||||||||||
Payer
Group
|
0-30 |
%
|
30-60 |
%
|
60-90 |
%
|
90-120 |
%
|
>120
|
%
|
Total
|
%
|
||||||||||||||||||||||||||||||||||||
Client
|
$ | 146,005 | 9 | % | $ | 150,698 | 10 | % | $ | 79,481 | 5 | % | $ | 8,606 | 1 | % | $ | 33,827 | 2 | % | $ | 418,618 | 27 | % | ||||||||||||||||||||||||
Commercial
Insurance
|
133,333 | 8 | % | 105,464 | 7 | % | 58,026 | 4 | % | 48,847 | 3 | % | 35,248 | 2 | % | 380,919 | 24 | % | ||||||||||||||||||||||||||||||
Medicare
|
293,298 | 19 | % | 282,463 | 18 | % | 71,283 | 5 | % | 68,830 | 4 | % | 56,598 | 4 | % | 772,472 | 49 | % | ||||||||||||||||||||||||||||||
Medicaid
|
325 | 0 | % | 650 | 0 | % | 2,588 | 0 | % | 400 | 0 | % | - | 0 | % | 3,963 | 0 | % | ||||||||||||||||||||||||||||||
Self-pay
|
135 | 0 | % | 2,058 | 0 | % | 723 | 0 | % | - | 0 | % | - | 0 | % | 2,916 | 0 | % | ||||||||||||||||||||||||||||||
Total
|
$ | 573,096 | 36 | % | $ | 541,334 | 34 | % | $ | 212,102 | 13 | % | $ | 126,684 | 8 | % | $ | 125,672 | 8 | % | $ | 1,578,887 | 100 | % | ||||||||||||||||||||||||
FY
2005
|
||||||||||||||||||||||||||||||||||||||||||||||||
Payer
Group
|
0-30 |
%
|
30-60 |
%
|
60-90 |
%
|
90-120 |
%
|
>120
|
%
|
Total
|
%
|
||||||||||||||||||||||||||||||||||||
Client
|
$ | 93,494 | 16 | % | $ | 91,922 | 16 | % | $ | 27,619 | 5 | % | $ | 15,799 | 3 | % | $ | 14,508 | 3 | % | $ | 243,341 | 43 | % | ||||||||||||||||||||||||
Commercial
Insurance
|
34,993 | 6 | % | 46,234 | 8 | % | 14,132 | 2 | % | 21,810 | 4 | % | 14,642 | 3 | % | 131,811 | 23 | % | ||||||||||||||||||||||||||||||
Medicare
|
115,484 | 20 | % | 26,905 | 5 | % | 16,668 | 3 | % | 10,618 | 2 | % | 15,777 | 3 | % | 185,452 | 32 | % | ||||||||||||||||||||||||||||||
Medicaid
|
1,183 | 0 | % | 354 | 0 | % | 950 | 0 | % | 1,624 | 0 | % | 288 | 0 | % | 4,399 | 1 | % | ||||||||||||||||||||||||||||||
Self-pay
|
1,304 | 0 | % | 1,755 | 0 | % | 2,382 | 0 | % | 1,445 | 0 | % | - | 0 | % | 6,885 | 1 | % | ||||||||||||||||||||||||||||||
Total
|
$ | 246,457 | 43 | % | $ | 167,170 | 29 | % | $ | 61,750 | 11 | % | $ | 51,296 | 9 | % | $ | 45,215 | 8 | % | $ | 571,888 | 100 | % |
Stock-Based
Compensation
Prior to
January 1, 2006, we accounted for stock-based awards and our Employee Stock
Purchase Plan using the intrinsic method in accordance with APB Opinion
No. 25, “Accounting for
Stock Issued to Employees”, FASB Interpretation No. 44 (“FIN
44”) “Accounting for Certain
Transactions Involving Stock-Based Compensation, an Interpretation of APB
Opinion No. 25”,FASB Technical Bulletin
No. 97-1 (“FTB 97-1”)
“Accounting under Statement 123 for Certain Employee Stock Purchase Plans with a
Look-Back Option”, and related interpretations
and provided the required pro forma disclosures of SFAS 123 “Accounting for
Stock-Based Compensation ”. In accordance with APB 25, a
non-cash, stock-based compensation expense was recognized for any options for
which the exercise price was below the market price on the actual grant date and
for any grants that were modified from their original terms. The charge
for the options with an exercise price below the market price on the actual
grant date was equal to the number of options multiplied by the difference
between the exercise price and the market price of the option shares on the
actual grant date. That expense was amortized over the vesting period of
the options. The charge for modifications of options in general was equal
to the number of options modified multiplied by the difference between the
market price of the options
on the modification date and the grant price. The charge for modified
options was taken over the remaining service period, if any.
28
Effective
January 1, 2006, we adopted SFAS 123(R), which requires the measurement at
fair value and recognition of compensation expense for all stock-based payment
awards. We selected the modified prospective method of adoption which
recognizes compensation expense for the fair value of all stock-based payments
granted after January 1, 2006 and for the fair value of all awards granted
to employees prior to January 1, 2006 that remain unvested on the date of
adoption. We used the trinomial lattice valuation model to estimate fair
value of stock option grants made on or after January 1, 2006. The
trinomial lattice option-pricing model requires the estimation of highly complex
and subjective variables. These variables include expected volatility,
expected life of the award, expected dividend rate and expected risk-free rate
of return. The assumptions for expected volatility and expected life are
the two assumptions that most significantly affect the grant date fair value.
The expected volatility is a blended rate based on both the historical
volatility of our stock price and the volatility of certain peer company stock
prices. The expected term assumption for our stock option grants was
determined using trinomial lattice simulation model which projects future option
holder behavior patterns based upon actual historical option exercises.
SFAS 123(R) also requires the application of a forfeiture rate to the
calculated fair value of stock options on a prospective basis. Our
assumption of forfeiture rate represents the historical rate at which our
stock-based awards were surrendered prior to vesting over the trailing four
years. If our assumption of forfeiture rate changes, we would have to make
a cumulative adjustment in the current period. We monitor the assumptions
used to compute the fair value of our stock options and ESPP awards on a regular
basis and we will revise our assumptions as appropriate. See
Note A – Formation and Operations of the Company and Summary of
Significant Accounting Policies section, “Stock-based compensation” subsection
and Note E – 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 twelve months ended December 31, 2006 as compared with the twelve months
ended December 31, 2005
Revenue
During
the fiscal year ended December 31, 2006, our revenues increased approximately
244% to $6,476,000 from $1,885,000 during the fiscal year ended December 31,
2005. This was the result of an increase in testing volume of 214% and a 9%
increase in average revenue per test. This volume
increase is the result of wide acceptance of our bundled testing product
offering and our industry leading turnaround times resulting in new
customers. The increase in average revenue per test is a direct
result of restructuring arrangements with certain existing customers that
increased average revenue per test and realigning our pricing policies with new
customers.
During
the twelve months ended December 31, 2006, our average revenue per customer
requisition increased by approximately 7% to $677.19 from $632.23 in
2005. Our average revenue per test increased by approximately 9% to
$504.44 from $461.86 in 2005. This was primarily as a result of price
increases to certain customers as well as product and payer mix
changes. Revenues per test are a function of both the nature of
the test and the payer (Medicare, Medicaid, third party insurer, institutional
client etc.). Our policy is to record as revenue the amounts that we
expect to collect based on published or contracted amounts and/or prior
experience with the payer. We have established a reserve for
uncollectible
29
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) co-payments directly
from patients, and c) those procedures that are not covered by insurance or
other third party payers. On December 31, 2006, our Allowance
for Doubtful Accounts was approximately $103,500, a 174% increase from our
balance at December 31, 2005 of $37,800. The allowance for doubtful
accounts was approximately 6.0% of accounts receivables on December 31, 2006 and
December 31, 2005.
Cost of
Revenue
During
2006, our cost of revenue increased approximately 144% to $2,759,000 from
$1,133,000 in 2005, primarily as a result of the 214% increase in testing
volumes as well as increased costs from opening new lines of business and this
is explained further as follows:
|
·
|
Increase
of approximately 234% in employee labor and benefit related
costs
|
|
·
|
Increase
of approximately 136% in supply costs;
and
|
|
·
|
Increase
of approximately 183% in postage and delivery
costs
|
Gross
Profit
As
a result of the 244% increase in revenue and 144% increase in cost of revenue,
our gross profit increased 394% to $3,717,000 in 2006, from a gross profit of
$753,000 in 2005. When expressed as a percentage of revenue, our gross margins
increased from 39.9% in 2005 to 57.4% in 2006. This increase in gross
profit and gross profit margin was largely a result of higher testing volumes in
2006 and the economies of scale related to such higher volumes.
General and Administrative
Expenses
During
2006, our general and administrative expenses increased by approximately 130% to
$3,577,000 from approximately $1,553,000 in 2005. This increase was primarily a
result of higher personnel and personnel-related expenses associated with the
increase in management, sales and administrative headcount that was necessary to
manage the significant increases in test volumes described above. In addition to
management, sales, and administrative personnel, our general and administrative
expenses also include all overhead and technology expenses as well, which have
also increased as a result of higher test volumes. Finally we had an
increase in bad debt expense as a result of increased revenue.
Other
Income/Expense
Other
income for the twelve months ended December 31, 2006 consisted of approximately
$56,000 related to the settlement on December 29, 2006 of our 2002 research and
license agreement with Ciphergen Biosystems. We paid Ciphergen
$34,000 to discharge our required performance under the research and license
agreement. We had approximately $90,000 of deferred revenue related
to that agreement which was reversed and resulted in other
income. However, the company also recorded in General and
Administrative expenses a $53,000 impairment related to the write-off
of the remaining undepreciated book value of the Ciphergen protein chip mass
spectrometer.
Interest
expense for 2006 increased approximately 65% to approximately $326,000 from
approximately $197,000 for 2005. Interest expense is primarily
comprised of interest payable on advances under our Credit Facility with Aspen,
which has increased as a result of our increased
borrowing to fund operations and increases in the prime interest rate during
2006, and to a lesser extent interest on capital leases entered into during
2006.
30
Net Loss
As
a result of the foregoing, our net loss decreased by approximately 87% to
$130,000 in 2006 from $997,000 in 2005.
Liquidity
and Capital Resources
During
the fiscal year ended December 31, 2006, our operating activities used
approximately $694,000 in cash compared with $902,000 used in
2005. This amount primarily represented cash tied-up in receivables
as a result of increased revenues and to a lesser extent cash used to pay the
expenses associated with our operations as well as fund our other working
capital. We also spent approximately $399,000 on new equipment in
2006 compared with $118,000 in 2005. We were able to finance
operations and equipment purchases primarily through the sale of equity
securities which provided approximately $1,090,000 and to a lessor extent with
borrowings on the Aspen credit facility. This resulted in net cash provided by
financing activities of approximately $1,208,000 in 2006 compared to $918,000 in
2005. At December 31, 2006 and December 31, 2005, we had cash and
cash equivalents of approximately $126,000, and $11,000
respectively.
On January 18, 2006, the Company
entered into a binding letter agreement (the "Aspen Agreement") with Aspen
Select Healthcare, LP, which provided, among other things, that:
(a) Aspen
waived certain pre-emptive rights in connection with the sale of $400,000 of
common stock at a purchase price of $0.20/share and the granting of 900,000
warrants with an exercise price of $0.26/share to SKL Limited Partnership, LP
("SKL" as more fully described below) in exchange for five year warrants to
purchase 150,000 shares at an exercise price of $0.26/share (the “Waiver
Warrants”).
(b) Aspen
had the right, up to April 30, 2006, to purchase up to $200,000 of restricted
shares of the Company's common stock at a purchase price per share of
$0.20/share (1,000,000 shares) and receive a five year warrant to purchase
450,000 shares of the Company's common stock at an exercise price of $0.26/share
in connection with such purchase (the "Equity Purchase Rights"). On March 14,
2006, Aspen exercised its Equity Purchase Rights.
(c) Aspen
and the Company amended the Loan Agreement, dated March 23, 2005 (the "Loan
Agreement") between the parties to extend the maturity date until September 30,
2007 and to modify certain covenants (such Loan Agreement as amended, the
"Credit Facility Amendment").
(d)
Aspen had the right, until April 30, 2006, to provide up to $200,000 of
additional secured indebtedness to the Company under the Credit Facility
Amendment and to receive a five year warrant to purchase up to 450,000 shares of
the Company's common stock with an exercise price of $0.26/share (the "New Debt
Rights").On March 30, 2006, Aspen exercised its New Debt Rights and entered into
the definitive transaction documentation for the Credit Facility Amendment and
other such documents required under the Aspen Agreement.
(e) The
Company agreed to amend and restate the warrant agreement, dated March
23,
31
2005,
which more formally implemented the original agreement made on February 18, 2005
with respect to such warrants, to provide that all 2,500,000 warrant shares (the
"Existing Warrants") were vested and the exercise price was reset to $0.31 per
share. The difference between the value of the
warrants on the original February 18, 2005 measurement date which was calculated
using an exercise price of $0.50/share, and their value on the January 18, 2006
modification date which was calculated using an exercise price of $0.31/share,
amounted to $2,365 and was credited to additional paid-in capital and included
in deferred financing fees.
(f) The
Company agreed to amend the Registration Rights Agreement, dated March 23, 2005
(the "Registration Rights Agreement"), between the parties to incorporate the
Existing Warrants, the Waiver Warrants and any new shares or warrants issued to
Aspen in connection with the Equity Purchase Rights or the New Debt
Rights.
(g) All
Waiver Warrants, the Existing Warrants and all warrants issued to Aspen and SKL
in connection with the purchase of equity or debt securities are exercisable at
the option of the holder for a term of five years, and each such warrant
contains provisions that allow for a physical exercise, a net cash exercise or a
net share settlement. We used the Black-Scholes pricing model to
estimate the fair value of all such warrants as of the measurement date for
each, using the following approximate assumptions: dividend yield of 0 %,
expected volatility of 14.6 – 19.3% (depending on the measurement date),
risk-free interest rate of 4.5%, and a term or expected life of 3 - 5
years.
We
borrowed an additional $100,000 from the Aspen credit facility in May 2006,
$25,000 in September 2006 and $50,000 in December 2006. At December
31, 2006, $1,675,000 was outstanding on the credit facility, which bears
interest at prime plus 6%, and $25,000 remained available. Subsequent
to December 31, 2006 we borrowed the remaining $25,000 available under the Aspen
Facility.
During the period from January 18 - 21,
2006, the Company entered into agreements with four other shareholders who are
parties to a Shareholders’ Agreement, dated March 23, 2005, to exchange five
year warrants to purchase an aggregate of 150,000 shares of stock at an exercise
price of $0.26/share for such shareholders’ waiver of their pre-emptive rights
under the Shareholders’ Agreement.
On January 21, 2006 the Company entered
into a subscription agreement (the "Subscription") with SKL Family Limited
Partnership, LP, a New Jersey limited partnership, whereby SKL purchased 2.0
million shares (the "Subscription Shares") of the Company's common stock at a
purchase price of $0.20/share for $400,000. Under the terms of the Subscription,
the Subscription Shares are restricted for a period of 24 months and then carry
piggyback registration rights to the extent that exemptions under Rule 144 are
not available to SKL. In connection with the Subscription, the Company also
issued a five year warrant to purchase 900,000 shares of the Company's common
stock at an exercise price of $0.26/share. SKL has no previous
affiliation with the Company.
On June
6, 2005, we entered into a Standby Equity Distribution Agreement (“S.E.D.A.”)
with Cornell Capital Partners, LP (“Cornell”). Pursuant to the
S.E.D.A., the Company may, at its discretion, periodically sell to Cornell
shares of common stock for a total purchase price of up to $5.0
million.
32
On June
6, 2006 as a result of not terminating our S.E.D.A. with Cornell, a short-term
note payable in the amount of $50,000 became due to Cornell and was subsequently
paid in July 2006 from the proceeds of a $53,000 advance under the
S.E.D.A.
The
following sales of common stock have been made under our S.E.D.A. with Cornell
since it was first declared effective on August 1, 2005.
Request
|
Completion
|
Shares
of
|
Gross
|
Cornell
|
Escrow
|
Net
|
|||||||||||||||||||
Date
|
Date
|
Common
Stock
|
Proceeds
|
Fee
|
Fee
|
Proceeds
|
ASP(1)
|
||||||||||||||||||
8/29/2005
|
9/8/2005
|
63,776 | $ | 25,000 | $ | 1,250 | $ | 500 | $ | 23,250 | |||||||||||||||
12/10/2005
|
12/18/2005
|
241,779 | 50,000 | 2,500 | 500 | 47,000 | |||||||||||||||||||
Subtotal
– 2005
|
305,555 | $ | 75,000 | $ | 3,750 | $ | 1,000 | $ | 70,250 | $ | 0.25 | ||||||||||||||
7/19/2006
|
7/28/2006
|
83,491 | 53,000 | 2,500 | 500 | 50,000 | |||||||||||||||||||
8/8/2006
|
8/16/2006
|
279,486 | 250,000 | 12,500 | 500 | 237,000 | |||||||||||||||||||
10/18/2006
|
10/23/2006
|
167,842 | 200,000 | 10,000 | 500 | 189,500 | |||||||||||||||||||
Subtotal
– 2006
|
530,819 | $ | 503,000 | $ | 25,000 | $ | 1,500 | $ | 476,500 | $ | 0.95 | ||||||||||||||
12/29/2006
|
1/10/2007
|
98,522 | 150,000 | 7,500 | 500 | 142,000 | |||||||||||||||||||
1/16/2007
|
1/24/2007
|
100,053 | 150,000 | 7,500 | 500 | 142,000 | |||||||||||||||||||
2/1/2007
|
2/12/2007
|
65,902 | 100,000 | 5,000 | 500 | 94,500 | |||||||||||||||||||
2/19/2007
|
2/28/2007
|
166,611 | 250,000 | 12,500 | 500 | 237,000 | |||||||||||||||||||
2/28/2007
|
3/7/2007
|
180,963 | 250,000 | 12,500 | 500 | 237,000 | |||||||||||||||||||
Subtotal
– 2007 YTD
|
612,051 | $ | 900,000 | $ | 45,000 | $ | 2,500 | $ | 852,500 | $ | 1.47 | ||||||||||||||
Total Since
Inception
|
1,448,425 | $ | 1,478,000 | $ | 73,750 | $ | 5,000 | $ | 1,399,250 | $ | 1.02 | ||||||||||||||
Remaining
|
- | $ | 3,522,000 | - | - | - | |||||||||||||||||||
Total
Facility
|
- | $ | 5,000,000 | - | - | - | |||||||||||||||||||
(1) Average
Selling Price of shares issued
At
the present time, we anticipate that based on our current business plan,
operations and our plans to repay or refinance the Aspen Credit Facility of $1.7
million that is due September 30, 2007, we will need to raise approximately $3 -
$5 million of new working capital in FY2007. This estimate of our
cash needs does not include any additional funding which may be required for
growth in our business beyond that which is planned, strategic transactions or
acquisitions. We plan to raise this additional money through issuing
a combination of debt and/or equity securities primarily to banks and/or other
large institutional investors. To the
33
extent we
are not successful in this regard, we plan to use our S.E.D.A. with Cornell,
which currently has $3,522,000 of remaining availability to fund our
operations. In the event that the Company grows faster than we
currently anticipate or we engage in strategic transactions or acquisitions and
our cash on hand and availability under the S.E.D.A. is not sufficient to meet
our financing needs, we may need to raise additional capital from other
resources. In such event, the Company may not be able to obtain such
funding on attractive terms or at all and the Company may be required to curtail
its operation. On March 29, 2007 we had approximately $274,000 in cash on
hand.
Capital
Expenditures
We
currently forecast capital expenditures for 2007 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 $1,500,000 to $2,000,000 of additional
capital equipment during the next twelve months. We plan to fund
these expenditures via capital leases. 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.
Commitments
Operating
Leases
In August
2003, we entered into a three year lease for 5,200 square feet at our laboratory
facility in Fort Myers, Florida. On June 29, 2006 we signed an
amendment to the original lease which extended the lease through June 30,
2011. The amendment included the rental of an additional 4,400 square
feet adjacent to our current facility. This space will allow
for future expansion of our business. The lease was further amended on January
17, 2007 but this amendment did not materially alter the terms of the lease,
which has total payments of approximately $653,000 over the remaining life of
the lease, including annual increases of rental payments of 3% per
year. Such amount excludes estimated operating and maintenance
expenses and property taxes.
As part
of the acquisition of The Center for CytoGenetics, Inc. by the Company on April
18, 2006, we assumed the lease of an 850 square foot facility in Nashville,
Tennessee. The lease expires on August 31, 2008. The
average monthly rental expense is approximately $1,350 per
month. This space was not adequate for our future plans and the
Company is currently not using the facility and is actively trying to sublease
this facility. On June 15, 2006, we entered into a lease for a new
facility totaling 5,386 square feet of laboratory space in Nashville, Tennessee.
This space will be adequate to accommodate our current plans for the Tennessee
laboratory. As part of the lease, we have the right of first refusal on an
additional 2,420 square feet, if needed, directly adjacent to the
facility. The lease is a five year lease and results in total
payments by us of approximately $340,000.
On August
1, 2006, the Company entered into a lease for 1,800 square feet of laboratory
space in Irvine, California. The lease is a nine month lease and results in
total payments by the Company of approximately $23,000. This lease
will expire on April 30, 2007. We are currently in negotiations on a new larger
facility, which can accommodate our future growth.
34
Future
minimum lease payments under these leases as of December 31, 2006 are as
follows:
Years ending December
31,
|
Amounts
|
|||
2007
|
$ | 227,082 | ||
2008
|
219,471 | |||
2009
|
214,015 | |||
2010
|
219,907 | |||
2011
|
105,710 | |||
Total
minimum lease payments
|
$ | 986,185 |
Capital
Leases
During 2006, we entered into the
following capital leases:
Date
|
Type
|
Months
|
Cost
|
Monthly
Payment
|
Balance
at
December
31
|
|
March
2006
|
Laboratory
Equipment
|
60
|
$134,200
|
$2,692
|
$117,117
|
|
August
2006
|
Laboratory
Equipment
|
60
|
48,200
|
1,200
|
43,724
|
|
August
2006
|
Laboratory
Equipment
|
60
|
98,400
|
2,366
|
90,140
|
|
August
2006
|
Laboratory
Equipment
|
60
|
101,057
|
2,316
|
89,630
|
|
August
2006
|
Laboratory
Equipment
|
60
|
100,200
|
2,105
|
86,740
|
|
November
2006
|
Laboratory
Equipment
|
60
|
19,900
|
434
|
19,348
|
|
November
2006
|
Computer
Equipment
|
60
|
9,700
|
228
|
9,366
|
|
December
2006
|
Computer
Equipment
|
48
|
19,292
|
549
|
17,742
|
|
December
2006
|
Computer
Equipment
|
48
|
25,308
|
718
|
24,003
|
|
December
2006
|
Office
Equipment
|
60
|
46,100
|
994
|
45,567
|
|
Total
|
$602,357
|
$13,602
|
$543,377
|
Future
minimum lease payments under these leases as of December 31, 2006 are as
follows:
Years ending December
31,
|
Amounts
|
|||
2007
|
$ | 163,219 | ||
2008
|
163,219 | |||
2009
|
163,219 | |||
2010
|
161,951 | |||
2011
|
89,582 | |||
Total
future minimum lease payments
|
741,190 | |||
Less
amount representing interest
|
197,813 | |||
Present
value of future minimum lease payments
|
543,377 | |||
Less
current maturities
|
94,430 | |||
Obligations
under capital leases – long term
|
$ | 448,947 |
The
equipment covered under the lease agreements is pledged as collateral to secure
the performance of the future minimum lease payments above.
35
Legal
Contingency
On October 26, 2006, Accupath
Diagnostics Laboratories, Inc. d/b/a US Labs (“US Labs”) filed a complaint in
the Superior Court of the State of California for the County of Los Angeles
naming as defendants the Company and its president, Robert
Gasparini. Also individually named are Company employees Jeffrey
Schreier, Maria Miller, Douglas White and Gary Roche.
The complaint alleges the following
causes of action: 1) Misappropriation of Trade Secrets; 2) Tortious
Interference with Prospective Economic Advantage; 3) Unfair Competition (Common
Law); and 4) Unfair Competition (Cal. Bus. & Prof. Code section
17200). The allegations are the result of the Company's hiring four
salespeople who were formerly employed by US Labs. Specifically, US
Labs alleges that the Company had access to the US Labs salaries of the new
hires, and was therefore able to obtain them as employees.
US Labs also sought broad injunctive
relief against NeoGenomics preventing the Company from doing business with its
customers. US Labs requests were largely denied, but the court did
issue a much narrower preliminary injunction that prevents NeoGenomics from
soliciting the four new employees' former US Labs customers until
trial.
Discovery commenced in December
2006. While the Company received unsolicited and inaccurate salary
information for three individuals that were ultimately hired, no evidence of
misappropriation of trade secrets has been discovered by either
side. As such, the Company is currently contemplating filing motions
to narrow or end the litigation, and expects to ultimately prevail at
trial.
We believe that none of US Labs’ claims
will be affirmed at trial; however, even if they were, NeoGenomics does not
believe such claims would result in a material impact to our
business. At this time we cannot accurately predict our legal fees
but if this case were to proceed to trial, we estimate that our legal fees could
be as high as $300,000 to $400,000 in FY 2007.
Purchase
Commitment
On
June 22, 2006, we entered into an agreement to purchase three automated FISH
signal detection and analysis systems over the next 24 months for a total of
$420,000. We agreed to purchase two systems immediately and to
purchase a third system in the next 15 months if the vendor is able to make
certain improvements to the system. As of December 31, 2006, the
Company had purchased and installed 2 of the systems.
Subsequent
Event
On April 2, 2007, we concluded an
agreement with Power3 Medical Products, Inc., a New York Corporation (“Power3”)
regarding the formation of a joint venture Contract Research Organization
(“CRO”) and the issuance of convertible debentures and related securities by
Power3 to us. Power3 is an early stage company engaged in the
discovery, development, and commercialization of protein
biomarkers. Under the terms of the agreement, NeoGenomics and Power3
will jointly own a CRO and begin commercializing Power3’s intellectual property
portfolio of 17 patents pending by developing diagnostic tests and other
services around one or more of the 523 protein biomarkers that Power3 believes
it has discovered to date. Power3 has agreed to license all of its
intellectual property on a non-exclusive basis to the CRO for
selected
36
commercial
applications as well as provide certain management personnel. We will
provide access to cancer samples, management and sales & marketing
personnel, laboratory facilities and working capital. Subject to
final negotiation, we will own a minimum of 60% and up to 80% of the new CRO
venture which is anticipated to be launched in the third or fourth quarter of FY
2007.
As part of the agreement, we will
provide $200,000 of working capital to Power3 by purchasing a convertible
debenture on or before April 16, 2007. We were also granted two
options to increase our stake in Power3 to up to 60% of the Power3 fully diluted
shares outstanding. The first option (the “First Option”) is a fixed
option to purchase convertible preferred stock of Power3 that is convertible
into such number of shares of Power3 common stock, in one or more transactions,
up to 20% of Power3’s voting common stock at a purchase price per share, which
will also equal the initial conversion price per share, equal to the lesser of
a) $0.20/share, or b) an equity valuation of $20,000,000 divided by the
fully-diluted shares outstanding on the date of the exercise of the First
Option. This 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 a) November 16, 2007 or b) the date that certain
milestones specified in the agreement have been achieved. The First
Option is exercisable in cash or NeoGenomics common stock at our option,
provided, however, that we must include at least $1.0 million of cash in the
consideration if we elect to exercise this First Option. In addition
to purchasing convertible preferred stock as part of the First Option, we are
also entitled to receive that number of warrants which is equal to the same
percentage as the percentage of convertible preferred stock being purchased on
such day of Power3’s warrants and options. Such warrants will have an
exercise price equal to the initial conversion price of the convertible
preferred stock that was purchased and will have a five year term.
The second option (the “Second
Option”), which is only exercisable to the extent that we have exercised the
First Option, provides that we will have the option to increase our stake in
Power3 to up to 60% of fully diluted shares of Power3 over the twelve month
period beginning on the expiration date of the First Option in one or a series
of transactions by purchasing additional convertible preferred stock of Power3
that is convertible into voting common stock and receiving additional
warrants. The purchase price per share, and the initial conversion
price of the Second Option convertible preferred stock will, to the extent such
Second Option is exercised within six (6) months of exercise of the First
Option, be the lesser of a) $0.40/share or b) an equity price per share equal to
$40,000,000 divided by the fully diluted shares outstanding on the date of any
purchase. The purchase price per share, and the initial conversion
price of the Second Option convertible preferred stock will, to the extent such
Second Option is exercised after six (6) months, but within twelve (12) months
of exercise of the First Option, be the lesser of a) $0.50/share or b) an equity
price per share equal to $50,000,000 divided by the fully diluted shares
outstanding on the date of any purchase. The exercise price of
the Second Option may be paid in cash or in any combination of cash and our
common stock at our option. In addition to purchasing convertible
preferred stock as part of the Second Option, we are also entitled to receive
that number of warrants which is equal to the same percentage as the percentage
of convertible preferred stock being purchased on such day of Power3’s warrants
and options. Such warrants will have an exercise price equal to the
initial conversion price of the convertible preferred stock being purchased that
date and will have a five year term.
Employment
Contracts
On
December 14, 2004, we entered into an employment agreement with Robert P.
Gasparini to serve as our President and Chief Science Officer. The employment
agreement has an initial term of three years, effective January 3, 2005;
provided, however that either party may
37
terminate
the agreement by giving the other party sixty days written notice. The
employment agreement specifies an initial base salary of $150,000/year, with
specified salary increases to $185,000/year over the first 18 months of the
contract. Mr. Gasparini is also entitled to receive cash bonuses for any given
fiscal year in an amount equal to 15% of his base salary if he meets certain
targets established by the Board of Directors. In addition, Mr. Gasparini was
granted 1,000,000 Incentive Stock Options that have a ten year term so long as
Mr. Gasparini remains an employee of the Company (these options, which vest
according to the passage of time and other performance-based milestones,
resulted in us recording stock based compensation expense under SFAS 123(R)
beginning in 2006. Mr. Gasparini's employment agreement also specifies that he
is entitled to four weeks of paid vacation per year and other health insurance
and relocation 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 employee benefits for a period of six months.
Recent Accounting
Pronouncements
SFAS 159 – ‘The Fair Value
Option for Financial Assets and Financial Liabilities—Including an amendment of
FASB Statement No. 115’
In February 2007, the FASB issued Financial Accounting
Standard No. 159 The Fair
Value Option for Financial Assets and Financial Liabilities—Including an
amendment of FASB Statement No. 115 or FAS 159. This Statement
permits entities to choose to measure many financial instruments and certain
other items at fair value. Most of the provisions of this Statement
apply only to entities that elect the fair value option.
The
following are eligible items for the measurement option established by this
Statement:
|
1.
|
Recognized
financial assets and financial liabilities
except:
|
|
a.
|
An
investment in a subsidiary that the entity is required to
consolidate
|
|
b.
|
An
interest in a variable interest entity that the entity is required to
consolidate
|
|
c.
|
Employers’
and plans’ obligations (or assets representing net over funded positions)
for pension benefits, other postretirement benefits (including health care
and life insurance benefits), postemployment benefits, employee stock
option and stock purchase plans, and other forms of deferred compensation
arrangements.
|
|
d.
|
Financial
assets and financial liabilities recognized under leases as defined in
FASB Statement No. 13, Accounting for
Leases.
|
|
e.
|
Deposit
liabilities, withdrawable on demand, of banks, savings and loan
associations, credit unions, and other similar depository
institutions
|
|
f.
|
Financial
instruments that are, in whole or in part, classified by the issuer as a
component of shareholder’s equity (including “temporary equity”). An
example is a convertible debt security with a noncontingent beneficial
conversion feature.
|
|
2.
|
Firm
commitments that would otherwise not be recognized at inception and that
involve only financial instruments
|
|
3.
|
Nonfinancial
insurance contracts and warranties that the insurer can settle by paying a
third party to provide those goods or
services
|
|
4.
|
Host
financial instruments resulting from separation of an embedded
nonfinancial derivative instrument from a nonfinancial hybrid
instrument.
|
38
|
The
fair value option:
|
|
1.
|
May
be applied instrument by instrument, with a few exceptions, such as
investments otherwise accounted for by the equity
method
|
|
2.
|
Is
irrevocable (unless a new election date
occurs)
|
|
3.
|
Is
applied only to entire instruments and not to portions of
instruments.
|
The
Statement is effective as of the beginning of an entity’s first fiscal year that
begins after November 15, 2007. Early adoption is permitted as of the beginning
of a fiscal year that begins on or before November 15, 2007, provided the entity
also elects to apply the provisions of FASB Statement No. 157, Fair Value Measurements. We have not yet determined
what effect, if any, adoption of this Statement will have on our
financial position or results of operations.
SFAS 158 – ‘Employers’ Accounting for
Defined Benefit Pension and Other Postretirement Plans, an amendment of FASB
Statement Nos. 87, 88, 106, and 132(R)’
In
September 2006, the FASB issued Financial Accounting Standard No. 158, Employers’ Accounting for Defined
Benefit Pension and Other Postretirement Plans, an amendment of FASB Statement
Nos. 87, 88, 106, and 132(R), or FAS 158. This Statement requires an
employer that is a business entity and sponsors one or more single-employer
defined benefit plans to (a) recognize the funded status of a benefit
plan—measured as the difference between plan assets at fair value (with limited
exceptions) and the benefit obligation—in its statement of financial position;
(b) recognize, as a component of other comprehensive income, net of tax, the
gains or losses and prior service costs or credits that arise during the period
but are not recognized as components of net periodic benefit cost pursuant to
FAS 87, Employers’ Accounting
for Pensions, or FAS 106, Employers’ Accounting for
Postretirement Benefits Other Than Pensions; (c) measure defined benefit
plan assets and obligations as of the date of the employer’s fiscal year-end
statement of financial position (with limited exceptions); and (d) disclose in
the notes to financial statements additional information about certain effects
on net periodic benefit cost for the next fiscal year that arise from delayed
recognition of the gains or losses, prior service costs or credits, and
transition assets or obligations. An employer with publicly traded
equity securities is required to initially recognize the funded status of a
defined benefit postretirement plan and to provide the required disclosures as
of the end of the fiscal year ending after December 15, 2006. This statement is
not expected to have a significant effect on our financial
statements.
SFAS 157 – ‘Fair Value
Measurements’
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements”. This
standard establishes a standard definition for fair value establishes a
framework under generally accepted accounting principles for measuring fair
value and expands disclosure requirements for fair value measurements. This
standard is effective for financial statements issued for fiscal years beginning
after November 15, 2007. Adoption of this statement is not expected to
have any material effect on our financial position or results of
operations.
SAB 108 – ‘Considering the
Effects of Prior Year Misstatements when Quantifying Misstatements in Current
Year Financial Statements’
39
In
September 2006, the SEC issued Staff Accounting Bulletin No. 108 (SAB 108),
Considering the Effects of Prior Year Misstatements when Quantifying
Misstatements in Current Year Financial Statements. SAB 108 provides guidance on
the consideration of the effects of prior year unadjusted errors in quantifying
current year misstatements for the purpose of a materiality assessment. Adoption
of this statement is not expected to have any material effect on our financial
position or results of operations.
FIN 48 – ‘Accounting for
Uncertainty in Income Taxes’
In
June 2006, the FASB issued Interpretation No. 48 (“FIN 48”), “Accounting for
Uncertainty in Income Taxes”, an interpretation of SFAS No. 109. FIN
48 prescribes a comprehensive model for how companies should recognize, measure,
present and disclose uncertain tax positions taken or expected to be taken on a
tax return. Under FIN 48, we shall initially recognize tax positions
in the financial statements when it is more likely than not the position will be
sustained upon examination by the tax authorities. We shall initially
and subsequently measure such tax positions as the largest amount of tax benefit
that is greater than 50% likely of being realized upon ultimate settlement with
the tax authority assuming full knowledge of the position and all relevant
facts. FIN 48 also revises disclosure requirements to include an
annual tabular roll-forward of unrecognized tax benefits. We will
adopt this interpretation as required in 2007 and will apply its provisions to
all tax positions upon initial adoption with any cumulative effect adjustment
recognized as an adjustment to retained earnings. Adoption of this
statement is not expected to have any material effect on our financial position
or results of operations.
SFAS 156 – ‘Accounting for
Servicing of Financial Assets’
In
March 2006, the FASB issued SFAS 156 “Accounting for Servicing of Financial
Assets.” This Statement amends FASB Statement No. 140, “Accounting for Transfers
and Servicing of Financial Assets and Extinguishments of Liabilities,” with
respect to the accounting for separately recognized servicing assets and
servicing liabilities. This statement:
|
a.
|
Requires
an entity to recognize a servicing asset or servicing liability each time
it undertakes an obligation to service a financial asset by entering
into a servicing contract.
|
|
b.
|
Requires
all separately recognized servicing assets and servicing liabilities to be
initially measured at fair value, if
practicable.
|
|
c.
|
Permits
an entity to choose “Amortization method” or “Fair value measurement
method” for each class of separately recognized servicing assets and
servicing liabilities.
|
|
d.
|
At
its initial adoption, permits a one-time reclassification of
available-for-sale securities to trading securities by entities with
recognized servicing rights, without calling into question the treatment
of other available-for-sale securities under Statement 115, provided that
the available-for-sale securities are identified in some manner as
offsetting the entity’s exposure to changes in fair value of servicing
assets or servicing liabilities that a servicer elects to subsequently
measure at fair value.
|
|
e.
|
Requires
separate presentation of servicing assets and servicing liabilities
subsequently measured at fair value in the statement of financial position
and additional disclosures for all separately recognized servicing assets
and servicing liabilities.
|
40
This
statement is effective as of the beginning of the Company’s first fiscal year
that begins after September 15, 2006. Adoption of this statement is
not expected to have any material effect on our financial position or results of
operations.
SFAS 155 – ‘Accounting for
Certain Hybrid Financial Instruments—an amendment of FASB Statements No. 133 and
140’
This
Statement, issued in February 2006, amends FASB Statements No. 133, Accounting for Derivative
Instruments and Hedging Activities, and No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities. This
Statement resolves issues addressed in Statement 133 Implementation Issue No.
D1, “Application of Statement 133 to Beneficial Interests in Securitized
Financial Assets.”
This
Statement:
|
a.
|
Permits
fair value remeasurement for any hybrid financial instrument that contains
an embedded derivative that otherwise would require
bifurcation
|
|
b.
|
Clarifies
which interest-only strips and principal-only strips are not subject to
the requirements of Statement 133
|
|
c.
|
Establishes
a requirement to evaluate interests in securitized financial assets to
identify interests that are freestanding derivatives or that are hybrid
financial instruments that contain an embedded derivative requiring
bifurcation
|
|
d.
|
Clarifies
that concentrations of credit risk in the form of subordination are not
embedded derivatives
|
|
e.
|
Amends
Statement 140 to eliminate the prohibition on a qualifying special-purpose
entity from holding a derivative financial instrument that pertains to a
beneficial interest other than another derivative financial
instrument.
|
This
Statement is effective for all financial instruments acquired or issued after
the beginning of our first fiscal year that begins after September 15,
2006. The fair value election provided for in paragraph 4(c) of this
Statement may also be applied upon adoption of this Statement for hybrid
financial instruments that had been bifurcated under paragraph 12 of Statement
133 prior to the adoption of this Statement. Earlier adoption is permitted as of
the beginning of our fiscal year, provided we have not yet issued financial
statements, including financial statements for any interim period, for that
fiscal year. Provisions of this Statement may be applied to instruments that we
hold at the date of adoption on an instrument-by-instrument basis. Adoption of
this statement is not expected to have any material effect on our financial
position or results of operations.
Recently Adopted Accounting
Standards
Effective
January 1, 2006, we adopted the provisions of Statement of Financial
Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS
123R”) requiring that compensation cost relating to share-based payment
transactions be recognized in our financial statements. The cost is measured at
the grant date, based on the calculated fair value of the award, and is
recognized as an expense over the employee’s requisite service period (generally
the vesting period of the equity award). We adopted SFAS 123R using the modified
prospective method and, accordingly, did not restate prior periods to reflect
the fair value method of recognizing compensation cost. Under the modified
prospective approach, SFAS 123R applies to new awards and to awards that were
outstanding on January 1, 2006 that are subsequently modified, repurchased
or cancelled. See our critical accounting policies
above. See also the Stock Based Compensation subsection in Note A –
Formation and Operation of the Company
41
and
Significant Accounting Policies, and Note E – Stock-Based Compensation, to the
financial statements.
SFAS 154 'Accounting Changes
and Error Corrections--a replacement of APB Opinion No. 20 and FASB Statement
No. 3
In
May 2005, the Financial Accounting Standards Board ("FASB") issued Statement No.
154. This Statement replaces APB Opinion No. 20, Accounting Changes, and FASB
Statement No. 3, Reporting Accounting Changes in Interim Financial Statements,
and changes the requirements for the accounting for, and reporting of, a change
in accounting principle. This Statement applies to all voluntary changes in
accounting principle. It also applies to changes required by an accounting
pronouncement in the unusual instance that the pronouncement does not include
specific transition provisions. When a pronouncement includes specific
transition provisions, those provisions should be followed.
SFAS
154 is effective for accounting changes and corrections of errors made in fiscal
years beginning after December 15, 2005. Adoption of this Statement did not have
any material impact on our financial statements.
42
ITEM
7. FINANCIAL
STATEMENTS
NEOGENOMICS,
INC.
Consolidated
Financial Statements as of
December
31, 2006 and for the years ended
December
31, 2006 and 2005 and
Report
of Independent Registered Public Accounting Firm
43
INDEX TO CONSOLIDATED
FINANCIAL STATEMENTS
Page
Report
of Independent Registered Public Accounting Firm.
|
45
|
|
Consolidated
Balance Sheet as of December 31, 2006.
|
46
|
|
Consolidated
Statements of Operations for the years ended December 31, 2006 and
2005.
|
47
|
|
Consolidated
Statements of Stockholders’ Equity for the years
ended December 31, 2006 and 2005.
|
48
|
|
Consolidated
Statements of Cash Flows for the years ended December
31, 2006 and 2005.
|
49
|
|
Notes
to Consolidated Financial Statements.
|
50
|
44
[Letterhead
of Kingery & Crouse, P.A.]
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders of NeoGenomics, Inc. and
subsidiary:
We
have audited the accompanying consolidated balance sheet of NeoGenomics, Inc.
and subsidiary (collectively the “Company”), as of December 31, 2006,
and the related consolidated statements of operations, stockholders’ equity and
cash flows for the years ended December 31, 2006 and 2005. 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 audit 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,
2006, and the results of its operations and its cash flows for the years ended
December 31, 2006 and 2005, in conformity with accounting principles generally
accepted in the United States of America.
/s/ Kingery
& Crouse, P.A.
April
2, 2007
Tampa,
FL
45
NEOGENOMICS,
INC.
CONSOLIDATED
BALANCE SHEET AS OF DECEMBER 31, 2006
ASSETS
|
||||
CURRENT
ASSETS:
|
||||
Cash
and cash equivalents
|
$ | 126,266 | ||
Accounts
receivable (net of allowance for doubtful accounts of
$103,463)
|
1,549,758 | |||
Inventories
|
117,362 | |||
Other
current assets
|
102,172 | |||
Total
current assets
|
1,895,558 | |||
FURNITURE AND EQUIPMENT
(net of accumulated depreciation of $494,942)
|
1,202,487 | |||
OTHER
ASSETS
|
33,903 | |||
TOTAL
ASSETS
|
$ | 3,131,948 | ||
LIABILITIES AND STOCKHOLDERS’
EQUITY
|
||||
CURRENT
LIABILITIES:
|
||||
Accounts
payable
|
$ | 697,754 | ||
Accrued
compensation
|
133,490 | |||
Accrued
expenses and other liabilities
|
67,098 | |||
Due
to affiliates (net of discount
of $39,285)
|
1,635,715 | |||
Short-term
portion of equipment capital leases
|
94,430 | |||
Total
current liabilities
|
2,628,487 | |||
LONG
TERM LIABILITIES:
|
||||
Long-term
portion of equipment capital leases
|
448,947 | |||
TOTAL
LIABILITIES
|
3,077,434 | |||
STOCKHOLDERS’
EQUITY:
|
||||
Common
stock, $.001 par value, (100,000,000 shares authorized;
27,061,476
|
||||
shares
issued and outstanding)
|
27,061 | |||
Additional
paid-in capital
|
11,177,512 | |||
Accumulated
deficit
|
(11,150,059 | ) | ||
Total stockholders’ equity
|
54,514 | |||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 3,131,948 |
See notes
to consolidated financial statements.
46
NEOGENOMICS,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2006 AND 2005
2006
|
2005
|
|||||||
NET
REVENUE
|
$ | 6,475,996 | $ | 1,885,324 | ||||
COST
OF REVENUE
|
2,759,190 | 1,132,671 | ||||||
GROSS
MARGIN
|
3,716,806 | 752,653 | ||||||
OTHER
OPERATING EXPENSE
|
||||||||
General
and administrative
|
3,576,812 | 1,553,017 | ||||||
OTHER
(INCOME)/EXPENSE:
|
||||||||
Other
income
|
(55,970 | ) | (42 | ) | ||||
Interest
expense
|
325,625 | 196,838 | ||||||
Other
(income)/expense – net
|
269,655 | 196,796 | ||||||
NET
LOSS
|
$ | (129,661 | ) | $ | (997,160 | ) | ||
NET LOSS PER
SHARE - Basic and Diluted
|
$ | (0.00 | ) | $ | (0.04 | ) | ||
WEIGHTED
AVERAGE NUMBER
OF SHARES
OUTSTANDING – Basic and Diluted
|
26,166,031 | 22,264,435 | ||||||
See notes
to consolidated financial statements.
47
NEOGENOMICS,
INC.
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE YEARS ENDED DECEMBER 31, 2006 AND 2005
Common
|
Common
|
Additional
|
Deferred
|
|||||||||||||||||||||
Stock
|
Stock
|
Paid-In
|
Stock
|
Accumulated
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Compensation
|
Deficit
|
Total
|
|||||||||||||||||||
Balances,
December 31, 2004
|
21,539,416 | $ | 21,539 | $ | 9,603,664 | $ | (28,620 | ) | $ | (10,023,238 | ) | $ | (426,655 | ) | ||||||||||
Common
Stock issuances
|
1,237,103 | 1,237 | 394,763 | - | - | 396,000 | ||||||||||||||||||
Transaction
fees and expenses
|
- | - | (191,160 | ) | - | - | (191,160 | ) | ||||||||||||||||
Options
issued to Scientific Advisory Board members
|
- | - | - | 2,953 | - | 2,953 | ||||||||||||||||||
Value
of non-qualified stock options
|
- | - | 5,638 | (5,638 | ) | - | - | |||||||||||||||||
Warrants
issued for services
|
- | - | 187,722 | - | - | 187,722 | ||||||||||||||||||
Stock
issued for services
|
60,235 | 60 | 15,475 | - | - | 15,535 | ||||||||||||||||||
Deferred
stock compensation related to warrants issued for services
|
- | - | (10,794 | ) | 10,794 | - | - | |||||||||||||||||
Amortization
of deferred stock compensation
|
- | - | - | 17,826 | - | 17,826 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (997,160 | ) | (997,160 | ) | ||||||||||||||||
Balances,
December 31, 2005
|
22,836,754 | 22,836 | 10,005,308 | (2,685 | ) | (11,020,398 | ) | (994,939 | ) | |||||||||||||||
Common
Stock issuances for cash
|
3,530,819 | 3,531 | 1,099,469 | - | - | 1,103,000 | ||||||||||||||||||
Common
Stock issued for acquisition
|
100,000 | 100 | 49,900 | - | - | 50,000 | ||||||||||||||||||
Transaction
fees and expenses
|
- | - | (80,189 | ) | - | - | (80,189 | ) | ||||||||||||||||
Adjustment
of credit facility discount
|
- | - | 2,365 | - | 2,365 | |||||||||||||||||||
Exercise
of stock options and warrants
|
546,113 | 546 | 66,345 | - | - | 66,891 | ||||||||||||||||||
Warrants
and stock issued for services
|
7,618 | 8 | 7,642 | - | - | 7,650 | ||||||||||||||||||
Payment
of Note on Cornell Capital fee
|
- | - | (50,000 | ) | - | - | (50,000 | ) | ||||||||||||||||
Stock
issued to settle accounts payable
|
40,172 | 40 | 15,627 | - | - | 15,667 | ||||||||||||||||||
Reclassification
of deferred compensation to additional paid-in capital upon the adoption
of SFAS No. 123R
|
- | - | (2,685 | ) | 2,685 | - | - | |||||||||||||||||
Stock
compensation expense
|
- | - | 63,730 | - | - | 63,730 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (129,661 | ) | (129,661 | ) | ||||||||||||||||
Balances,
December 31, 2006
|
27,061,476 | $ | 27,061 | $ | 11,177,512 | $ | - | $ | (11,150,059 | ) | $ | 54,514 |
See notes
to consolidated financial statements.
48
NEOGENOMICS,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2006 AND 2005
2006
|
2005
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (129,661 | ) | $ | (997,160 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
233,632 | 123,998 | ||||||
Impairment
of fixed assets
|
53,524 | 50,000 | ||||||
Amortization
of credit facility discounts and debt issue costs
|
72,956 | 57,068 | ||||||
Stock
based compensation
|
63,730 | - | ||||||
Non-cash
consulting and bonuses
|
7,650 | 85,877 | ||||||
Provision
for bad debts
|
444,133 | 132,633 | ||||||
Other
non-cash expenses
|
59,804 | 29,576 | ||||||
Changes
in current assets and liabilities, net:
|
||||||||
Accounts
receivable, net
|
(1,442,791 | ) | (627,241 | ) | ||||
Inventory
|
(57,362 | ) | (44,878 | ) | ||||
Other
current assets
|
(101,805 | ) | (54,529 | ) | ||||
Deposits
|
(31,522 | ) | 300 | |||||
Deferred
revenues
|
(100,000 | ) | (10,000 | ) | ||||
Accounts
payable and accrued expenses
and
other liabilities
|
233,930 | 352,305 | ||||||
NET
CASH USED IN OPERATING ACTIVITIES:
|
(693,782 | ) | (902,051 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchases
of property and equipment
|
(398,618 | ) | (117,628 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Advances
from affiliates, net
|
175,000 | 760,000 | ||||||
Notes
payable
|
2,000 | - | ||||||
Repayments
of capital leases
|
(58,980 | ) | - | |||||
Debt
issue costs
|
- | (53,587 | ) | |||||
Issuances
of common stock for cash, net of transaction expenses
|
1,089,702 | 211,662 | ||||||
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
1,207,722 | 918,075 | ||||||
NET
CHANGE IN CASH AND CASH EQUIVALENTS
|
115,322 | (101, 604 | ) | |||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF YEAR
|
10,944 | 112,548 | ||||||
CASH
AND CASH EQUIVALENTS, END OF YEAR
|
$ | 126,266 | $ | 10,944 | ||||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||||
Interest
paid
|
$ | 269,316 | $ | 136,936 | ||||
Income
taxes paid
|
$ | - | $ | - | ||||
SUPPLEMENTAL
DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||
Equipment
leased under capital leases
|
$ | 602,357 | $ | - | ||||
Common
stock issued for acquisition
|
$ | 50,000 | $ | - | ||||
Common
stock issued for Cornell Capital financing
|
$ | 50,000 | $ | 143,208 |
See notes
to consolidated financial statements.
49
NEOGENOMICS,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE A – FORMATION AND OPERATIONS OF THE
COMPANY AND SIGNIFICANT ACCOUNTING POLICIES
NeoGenomics,
Inc. (“NEO” or the “Subsidiary”) was incorporated under the laws of the state of
Florida on June 1, 2001 and on November 14, 2001 agreed to be acquired by
American Communications Enterprises, Inc. (“ACE”, or the
“Parent”). ACE was formed in 1998 and succeeded to NEO’s name on
January 3, 2002 (NEO and ACE are collectively referred to as “we”, “us”, “our”
or the “Company”).
Principles of
Consolidation
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.
Reclassification
Certain
amounts in the prior year’s consolidated financial statements have been
reclassified to conform to the current year presentation.
Revenue
Recognition
Net
revenues are recognized in the period when tests are performed and consist
primarily of net patient revenues that are recorded based on established billing
rates less estimated discounts and contractual allowances principally for
patients covered by Medicare, Medicaid and managed care and other health
plans. Adjustments to the estimated discounts are recorded in the
period payment is received. These revenues also are subject to review
and possible audit by the payers. We believe that adequate provision
has been made for any adjustments that may result from final determination of
amounts earned under all the above arrangements. There are no known
material claims, disputes or unsettled matters with any payers that are not
adequately provided for in the accompanying consolidated financial
statements.
Accounts
Receivable
We record
accounts receivable net of estimated discounts, contractual allowances, and
allowances for bad debt. 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.
50
Concentrations of Credit
Risk
We
currently market our services to pathologists, oncologists, urologists,
hospitals and other clinical laboratories. During 2006, we performed
12,838 individual tests. Ongoing sales efforts have decreased
dependence on any given source of revenue. Notwithstanding this fact,
several key customers still account for a disproportionately large case volume
and revenues. In 2005, four customers accounted for 65% of our total
revenue. For the year ended December 31, 2006, three customers
represented 61% of our revenue with each party representing greater than 15% of
such revenues. As revenue continues to increase, these concentrations
are expected to decrease. In the event that we lost one of these
customers, we would potentially lose a significant percentage of our
revenues.
Financial
instruments that potentially subject us to significant concentrations of credit
risk consist principally of cash and cash equivalents. We maintain
all of our cash and cash equivalents in deposit accounts with several high
quality financial institutions, which accounts may at times exceed Federally
insured limits. We have not experienced any losses in such
accounts.
Inventories
Inventories,
which consist principally of supplies, are valued at the lower of cost (first
in, first out method) or market.
Use of
Estimates
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America requires us to
make certain estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the consolidated financial statements. The reported amounts of
revenues and expenses during the reporting period may be affected by the
estimates and assumptions we are required to make. Estimates that are
critical to the accompanying consolidated financial statements include estimates
related to the allowances discussed under Accounts Receivable above as well as
estimating stock-based compensation and depreciation periods of tangible assets,
and long-lived impairments, among others. The markets for our
services are characterized by intense price competition, evolving standards and
changes in healthcare regulations, all of which could impact the future
realizability of our assets. Estimates and assumptions are reviewed
periodically and the effects of revisions are reflected in the consolidated
financial statements in the period they are determined to be
necessary. It is at least reasonably possible that our estimates
could change in the near term with respect to these matters.
Financial
Instruments
We
believe the book value of our financial instruments included in our current
assets and liabilities approximates their fair values due to their short-term
nature.
We also
believe the book value of our long-term liabilities approximates their fair
value as the consideration (i.e. interest and, in certain cases, warrants) on
such obligations approximate the consideration at which similar types of
borrowing arrangements could be currently obtained.
Furniture and
Equipment
Furniture
and equipment are stated at cost. Major additions are capitalized,
while minor additions and maintenance and repairs, which do not extend the
useful life of an asset, are expensed
as incurred. Depreciation is provided using the straight-line method over the
assets’ estimated useful lives, which range from 3 to 7
years.
51
Long-Lived
Assets
Statement
of Financial Accounting Standards (SFAS) 144, "Accounting for the Impairment or
Disposal of Long-Lived Assets” requires that long-lived assets, including
certain identifiable intangibles, be reviewed for impairment whenever events or
changes in circumstances indicate that the carrying value of the assets in
question may not be recoverable. As a result of experiencing losses from
operations, we evaluated our long-lived assets during 2006 and 2005 and
determined that certain equipment had a remaining net book value in excess of
their fair value (as determined by our management). Accordingly, we
recorded an impairment loss of approximately $54,000 during the year ended
December 31, 2006 and $50,000 during the year ended December 31,
2005.
Income
Taxes
We
compute income taxes in accordance with Financial Accounting Standards Statement
No. 109 "Accounting for Income Taxes" ("SFAS 109"). Under SFAS 109,
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
furniture and equipment as well as impairment losses and the timing of
recognition of bad debts.
Stock-Based
Compensation
For the
years ended December 31, 2006 and 2005, the Company maintained a stock
option plan covering potential equity grants including primarily the issuance of
stock options. In addition, effective January 1, 2007, the Company began
sponsoring an Employee Stock Purchase Plan (“ESPP”), whereby eligible employees
are entitled to purchase Common Stock monthly, by means of limited payroll
deductions, at a 5% discount from the fair market value of the Common Stock as
of specific dates. The Company’s ESPP plan is considered exempt from fair
value accounting under SFAS No. 123R since the discount offered to employees is
only 5%. See Note E, “Stock Based Compensation,” of Notes to
Consolidated Financial Statements for a detailed description of the Company’s
plans.
Effective
January 1, 2006, we adopted Statement of Financial Accounting Standards
No. 123(R), “Share-Based
Payment” (“SFAS 123(R)”), which is a revision of Statement of Financial
Accounting Standards No. 123, “Accounting for Stock-Based
Compensation” (“SFAS 123”). SFAS 123(R) supersedes our previous
accounting under Accounting Principles Board Opinion No. 25 “Accounting for Stock Issued to
Employees” (“APB 25”) and disclosure under SFAS 123. In March 2005,
the SEC issued Staff Accounting Bulletin No. 107 (“SAB 107”) relating to
SFAS 123(R). We have applied the provisions of SAB 107 in our
adoption of SFAS 123(R). Under SFAS 123(R), compensation cost for all
stock-based awards, including grants of employee stock options, restricted stock
and other equity awards, is measured at fair value at grant date and recognized
as compensation expense on a straight line basis over the employees’ expected
requisite service period. In addition, SFAS 123(R) requires the benefits
of tax deductions in excess of recognized compensation expense to be reported as
a financing cash flow, rather than as an operating cash flow as prescribed under
previous accounting rules.
52
The
Company selected the modified prospective method of adoption, which recognizes
compensation expense for the fair value of all share-based payments granted
after January 1, 2006 and for the fair value of all awards granted to
employees prior to January 1, 2006 that remain unvested on the date of
adoption. This method does not require a restatement of prior periods.
However, awards granted and still unvested on the date of adoption will be
attributed to expense under SFAS 123(R), including the application of forfeiture
rate on a prospective basis. Our forfeiture rate represents the historical
rate at which our stock-based awards were surrendered prior to vesting.
SFAS 123(R) requires forfeitures to be estimated at the time of grant and
revised on a cumulative basis, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Prior to fiscal year 2006, the
Company accounted for forfeitures as they occurred, for the purposes of pro
forma information under SFAS 123.
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.
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.
Unamortized
Discount
Unamortized
discount resulting from transaction expenses incurred in the establishment of
the Credit Facility (see Note G) is being amortized to interest expense over the
contractual life of the Credit Facility (24 months) using the straight line
method.
Net Loss Per Common
Share
We
compute loss per share in accordance with Financial Accounting Standards
Statement No. 128 “Earnings per Share” (“SFAS 128”) and SEC Staff Accounting
Bulletin No. 98 (“SAB 98”). Under the provisions of SFAS No. 128 and
SAB 98, 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. Common
equivalent shares outstanding as of December 31, 2006 and 2005, which consisted
of employee stock options and certain warrants issued to consultants and other
providers of financing to the Company, were excluded from diluted net loss per
common share calculations as of such dates because they were
anti-dilutive.
Recent
Pronouncements
SFAS 159 – ‘The Fair Value
Option for Financial Assets and Financial Liabilities—Including an amendment of
FASB Statement No. 115’
In
February 2007, the FASB issued Financial Accounting
Standard No. 159 The Fair
Value Option for Financial Assets and Financial Liabilities—Including an
amendment of FASB Statement No. 115 or FAS 159. This Statement
permits entities to choose to measure many
53
financial
instruments and certain other items at fair value. Most of the
provisions of this Statement apply only to entities that elect the fair value
option.
The
following are eligible items for the measurement option established by this
Statement:
|
1.
|
Recognized
financial assets and financial liabilities
except:
|
|
a.
|
An
investment in a subsidiary that the entity is required to
consolidate
|
|
b.
|
An
interest in a variable interest entity that the entity is required to
consolidate
|
|
c.
|
Employers’
and plans’ obligations (or assets representing net overfunded positions)
for pension benefits, other postretirement benefits (including health care
and life insurance benefits), postemployment benefits, employee stock
option and stock purchase plans, and other forms of deferred compensation
arrangements.
|
|
d.
|
Financial
assets and financial liabilities recognized under leases as defined in
FASB Statement No. 13, Accounting for
Leases.
|
|
e.
|
Deposit
liabilities, withdrawable on demand, of banks, savings and loan
associations, credit unions, and other similar depository
institutions
|
|
f.
|
Financial
instruments that are, in whole or in part, classified by the issuer as a
component of shareholder’s equity (including “temporary equity”). An
example is a convertible debt security with a noncontingent beneficial
conversion feature.
|
|
2.
|
Firm
commitments that would otherwise not be recognized at inception and that
involve only financial instruments
|
|
3.
|
Nonfinancial
insurance contracts and warranties that the insurer can settle by paying a
third party to provide those goods or
services
|
|
4.
|
Host
financial instruments resulting from separation of an embedded
nonfinancial derivative instrument from a nonfinancial hybrid
instrument.
|
The fair
value option:
|
1.
|
May
be applied instrument by instrument, with a few exceptions, such as
investments otherwise accounted for by the equity
method
|
|
2.
|
Is
irrevocable (unless a new election date
occurs)
|
|
3.
|
Is
applied only to entire instruments and not to portions of
instruments.
|
The
Statement is effective as of the beginning of an entity’s first fiscal year that
begins after November 15, 2007. Early adoption is permitted as of the beginning
of a fiscal year that begins on or before November 15, 2007, provided the entity
also elects to apply the provisions of FASB Statement No. 157, Fair Value
Measurements. We have not yet determined what effect, if any,
adoption of this Statement will have on our financial position or results of
operations.
SFAS 158 – ‘Employers’ Accounting for
Defined Benefit Pension and Other Postretirement Plans, an amendment of FASB
Statement Nos. 87, 88, 106, and 132(R)’
In
September 2006, the FASB issued Financial Accounting Standard No. 158, Employers’ Accounting for Defined
Benefit Pension and Other Postretirement Plans, an amendment of FASB Statement
Nos. 87, 88, 106, and 132(R), or FAS 158. This Statement requires an
employer that is a business entity and sponsors one or more single-employer
defined benefit
54
plans to
(a) recognize the funded status of a benefit plan—measured as the difference
between plan assets at fair value (with limited exceptions) and the benefit
obligation—in its statement of financial position; (b) recognize, as a component
of other comprehensive income, net of tax, the gains or losses and prior service
costs or credits that arise during the period but are not recognized as
components of net periodic benefit cost pursuant to FAS 87, Employers’ Accounting for
Pensions, or FAS 106, Employers’ Accounting for
Postretirement Benefits Other Than Pensions; (c) measure defined benefit
plan assets and obligations as of the date of the employer’s fiscal year-end
statement of financial position (with limited exceptions); and (d) disclose in
the notes to financial statements additional information about certain effects
on net periodic benefit cost for the next fiscal year that arise from delayed
recognition of the gains or losses, prior service costs or credits, and
transition assets or obligations. An employer with publicly traded
equity securities is required to initially recognize the funded status of a
defined benefit postretirement plan and to provide the required disclosures as
of the end of the fiscal year ending after December 15, 2006. Adoption of this
statement is not expected to have any material effect on our financial position
or results of operations.
SFAS 157 – ‘Fair Value
Measurements’
In
September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. This
standard establishes a standard definition for fair value establishes a
framework under generally accepted accounting principles for measuring fair
value and expands disclosure requirements for fair value measurements. This
standard is effective for financial statements issued for fiscal years beginning
after November 15, 2007. Adoption of this statement is not expected to
have any material effect on our financial position or results of
operations.
SAB 108 – ‘Considering the
Effects of Prior Year Misstatements when Quantifying Misstatements in Current
Year Financial Statements’
In
September 2006, the SEC issued Staff Accounting Bulletin No. 108 (SAB 108),
Considering the Effects of
Prior Year Misstatements when Quantifying Misstatements in Current Year
Financial Statements. SAB 108 provides guidance on the consideration of
the effects of prior year unadjusted errors in quantifying current year
misstatements for the purpose of a materiality assessment. Adoption
of this statement is not expected to have any material effect on our financial
position or results of operations.
FIN 48 – ‘Accounting for
Uncertainty in Income Taxes’
In June
2006, the FASB issued Interpretation No. 48 (“FIN 48”), Accounting for Uncertainty in Income
Taxes, an interpretation of SFAS No. 109. FIN 48 prescribes a
comprehensive model for how companies should recognize, measure, present and
disclose uncertain tax positions taken or expected to be taken on a tax
return. Under FIN 48, we shall initially recognize tax positions in
the financial statements when it is more likely than not the position will be
sustained upon examination by the tax authorities. We shall initially
and subsequently measure such tax positions as the largest amount of tax benefit
that is greater than 50% likely of being realized upon ultimate settlement with
the tax authority assuming full knowledge of the position and all relevant
facts. FIN 48 also revises disclosure requirements to include an
annual tabular roll forward of unrecognized tax benefits. We will
adopt this interpretation as required in 2007 and will apply its provisions to
all tax positions upon initial adoption with any cumulative effect adjustment
recognized as an adjustment to retained earnings. Adoption of this statement is
not expected to have any material effect on our financial position or results of
operation.
55
SFAS 156 – ‘Accounting for
Servicing of Financial Assets’
In March
2006, the FASB issued SFAS 156, Accounting for Servicing of
Financial Assets. This Statement amends FASB Statement No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities, with
respect to the accounting for separately recognized servicing assets and
servicing liabilities. This statement:
|
a.
|
Requires
an entity to recognize a servicing asset or servicing liability each time
it undertakes an obligation to service a financial asset by entering
into a servicing contract.
|
|
b.
|
Requires
all separately recognized servicing assets and servicing liabilities to be
initially measured at fair value, if
practicable.
|
|
c.
|
Permits
an entity to choose “Amortization method” or “Fair value measurement
method” for each class of separately recognized servicing assets and
servicing liabilities.
|
|
d.
|
At
its initial adoption, permits a one-time reclassification of
available-for-sale securities to trading securities by entities with
recognized servicing rights, without calling into question the treatment
of other available-for-sale securities under Statement 115, provided that
the available-for-sale securities are identified in some manner as
offsetting the entity’s exposure to changes in fair value of servicing
assets or servicing liabilities that a servicer elects to subsequently
measure at fair value.
|
|
e.
|
Requires
separate presentation of servicing assets and servicing liabilities
subsequently measured at fair value in the statement of financial position
and additional disclosures for all separately recognized servicing assets
and servicing liabilities.
|
This
statement is effective as of the beginning of the Company’s first fiscal year
that begins after September 15, 2006. Adoption of this statement is
not expected to have any material effect on our financial position or results of
operations.
SFAS 155 – ‘Accounting for
Certain Hybrid Financial Instruments—an amendment of FASB Statements No. 133 and
140’
This
Statement, issued in February 2006, amends FASB Statements No. 133, Accounting for Derivative
Instruments and Hedging Activities, and No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities. This
Statement resolves issues addressed in Statement 133 Implementation Issue No.
D1, “Application of Statement 133 to Beneficial Interests in Securitized
Financial Assets.”
This
Statement:
|
a.
|
Permits
fair value remeasurement for any hybrid financial instrument that contains
an embedded derivative that otherwise would require
bifurcation
|
|
b.
|
Clarifies
which interest-only strips and principal-only strips are not subject to
the requirements of Statement 133
|
|
c.
|
Establishes
a requirement to evaluate interests in securitized financial assets to
identify interests that are freestanding derivatives or that are hybrid
financial instruments that contain an embedded derivative requiring
bifurcation
|
|
d.
|
Clarifies
that concentrations of credit risk in the form of subordination are not
embedded derivatives
|
56
|
e.
|
Amends
Statement 140 to eliminate the prohibition on a qualifying special-purpose
entity from holding a derivative financial instrument that pertains to a
beneficial interest other than another derivative financial
instrument.
|
This
Statement is effective for all financial instruments acquired or issued after
the beginning of our first fiscal year that begins after September 15,
2006.
The fair
value election provided for in paragraph 4(c) of this Statement may also be
applied upon adoption of this Statement for hybrid financial instruments that
had been bifurcated under paragraph 12 of Statement 133 prior to the adoption of
this Statement. Earlier adoption is permitted as of the beginning of our fiscal
year, provided we have not yet issued financial statements, including financial
statements for any interim period, for that fiscal year. Provisions of this
Statement may be applied to instruments that we hold at the date of adoption on
an instrument-by-instrument basis.
Adoption
of this statement is not expected to have any material effect on our financial
position or results of operations.
Recently Adopted Accounting
Standards
SFAS 154 'Accounting Changes
and Error Corrections--A Replacement of APB Opinion No. 20 and FASB Statement
No. 3
In May
2005, the Financial Accounting Standards Board ("FASB") issued Statement No.
154. This Statement replaces APB Opinion No. 20, Accounting Changes, and FASB
Statement No. 3, Reporting
Accounting Changes in Interim Financial Statements, and changes the
requirements for the accounting for, and reporting of, a change in accounting
principle. This Statement applies to all voluntary changes in accounting
principle. It also applies to changes required by an accounting pronouncement in
the unusual instance that the pronouncement does not include specific transition
provisions. When a pronouncement includes specific transition provisions, those
provisions should be followed.
SFAS 154
is effective for accounting changes and corrections of errors made in fiscal
years beginning after December 15, 2005. Adoption of this Statement did not have
any material impact on our financial statements.
Effective
January 1, 2006, we adopted the provisions of Statement of Financial
Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS
123R”) requiring that compensation cost relating to share-based payment
transactions be recognized in our financial statements. The cost is measured at
the grant date, based on the calculated fair value of the award, and is
recognized as an expense over the employee’s requisite service period (generally
the vesting period of the equity award). We adopted SFAS 123R using the modified
prospective method and, accordingly, did not restate prior periods to reflect
the fair value method of recognizing compensation cost. Under the modified
prospective approach, SFAS 123R applies to new awards and to awards that were
outstanding on January 1, 2006 that are subsequently modified, repurchased
or cancelled. See also Note E – Stock-Based Compensation, to the
financial statements.
NOTE
B – LIQUIDITY
57
Our
consolidated financial statements are prepared using accounting principles
generally accepted in the United States of America applicable to a going
concern, which contemplate the realization of assets and liquidation of
liabilities in the normal course of business. At December 31,
2006, we had stockholders’ equity of approximately
$54,000. Subsequent to December 31, 2006, we enhanced our working
capital by issuing 612,051 shares of common stock for $900,000. We
also have the ability to draw up to $3,522,000 available under our Standby
Equity Distribution Agreement with Cornell Capital. As such, we
believe we have adequate cash 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.
NOTE
C – FURNITURE AND EQUIPMENT, NET
Furniture
and equipment consists of the following at December 31, 2006:
Equipment
|
$ | 1,566,330 | ||
Leasehold
Improvements
|
12,945 | |||
Furniture
& Fixtures
|
118,154 | |||
Subtotal
|
$ | 1,697,429 | ||
Less
accumulated depreciation and amortization
|
(494,942) | |||
Furniture
and Equipment, net
|
$ | 1,202,487 |
Equipment
under capital leases, included above, consists of the following at December 31,
2006:
Equipment
|
$ | 585,131 | ||
Furniture
& Fixtures
|
17,226 | |||
Subtotal
|
$ | 602,357 | ||
Less
accumulated depreciation and amortization
|
(43,772) | |||
Furniture
and Equipment, net
|
$ | 558,585 |
NOTE
D - INCOME TAXES
We
recognized losses for both financial and tax reporting purposes during 2005, and
for financial reporting purposes during 2006 in the accompanying consolidated
statements of operations. As we have significant loss carryforwards
for tax purposes, no provisions for income taxes and/or deferred income taxes
payable have been provided in the accompanying consolidated financial
statements.
At
December 31, 2006, we have net operating loss carryforwards of approximately
$2,100,000 (the significant difference between this amount, and our accumulated
deficit of approximately $11,150,000 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 ended December 31, 2026. 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
58
SFAS 109.
Our valuation allowance decreased by $200 during the year ended December 31,
2006.
At
December 31, 2006, our current and
non-current deferred income tax assets (assuming an effective income tax rate of
approximately 40%) consisted of the following:
Net
current deferred income tax asset:
|
||||
Allowance
for doubtful accounts
|
$ | 39,900 | ||
Less
valuation allowance
|
(39,900) | |||
Total
|
$ | - |
Net
non-current deferred income tax asset:
|
||||
Net
operating loss carry forwards
|
$ | 816,500 | ||
Accumulated
depreciation and impairment
|
(75,600) | |||
Subtotal
|
740,900 | |||
Less
valuation allowance
|
(740,900) | |||
Total
|
$ | - |
NOTE
E - STOCK-BASED COMPENSATION
Stock Option
Plan
On
October 31, 2006, our shareholders and Board of Directors amended and restated
the NeoGenomics Equity Incentive Plan, which was originally approved in October
2003 (the “Plan”). The Plan permits the grant of stock awards and
stock options to officers, directors, employees and
consultants. Options granted under the Plan are either outright stock
awards, Incentive Stock Options (“ISOs”) or Non-Qualified Stock Options
(“NQSO’s). As part of this amendment and restatement, the
shareholders and Board of Directors approved an increase in the shares reserved
under the Plan from 10% of our outstanding common stock at any given time to 12%
of our Adjusted Diluted Shares Outstanding, which equated to 3,819,890 shares of
our common stock as of December 31, 2006. Adjusted Diluted Shares
Outstanding are defined as basic common shares outstanding on the measurement
date plus that number of shares that would be issued if all convertible debt,
convertible preferred equity securities and warrants were assumed to be
converted into common stock on the measurement date. The definition
of Adjusted Diluted Shares Outstanding specifically excludes any unexercised
stock options that may be outstanding under either the Stock Option Plan or the
ESPP on any measurement date. As of December 31, 2006, option and
stock awards totaling 2,107,000 shares were outstanding and 322,049 option and
stock awards had been exercised, leaving a total of 1,390,841 options and stock
awards available for future issuance. Options typically have a 10
year life and vest over 3 or 4 years but each grant’s 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 President by virtue of authority
delegated to him by the Compensation Committee.
59
Adoption
of SFAS 123(R)
Effective
January 1, 2006, we adopted SFAS 123(R), which requires the measurement and
recognition of compensation expense in the Company’s statement of operations for
all share-based payment awards made to our employees and directors, including
employee stock options and employee stock purchases related to all our
stock-based compensation plans based on estimated fair values.
SFAS
123(R) requires companies to estimate the fair value of stock-based compensation
on the date of grant using an option-pricing model. The fair value of the
award is recognized as expense over the requisite service periods in our
consolidated statement of operations using the straight-line method consistent
with the methodology used under SFAS 123. Under SFAS 123(R) the attributed
stock-based compensation expense must be reduced by an estimate of the
annualized rate of stock option forfeitures. The unrecognized expense of
awards not yet vested at the date of adoption is recognized in net income (loss)
in the periods after the date of adoption, using the same valuation method and
assumptions determined under the original provisions of SFAS
123. Additionally, our deferred stock compensation balance of $2,685
as of December 31, 2005, which was accounted for under APB 25, was
reclassified into additional paid in capital upon the adoption of SFAS
123(R) on January 1, 2006.
We
estimate the fair value of stock-based awards using the trinomial lattice
model. We also used the trinomial lattice model in preparing the pro
forma disclosure required under SFAS 123 for the year ended December 31,
2005. This model determines the fair value of stock-based compensation and
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 expected term, expected risk-free rate of return, expected
volatility, 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 such option is expected to be
outstanding. The average expected term is determined using the
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
used the nearest interest rate from the available maturities.
Expected Stock Price
Volatility: Effective January 1, 2006, 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 the nearest
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.
Dividend
Yield: Since 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, 2006
and 2005 were estimated as of the grant date using the trinomial lattice model
with the following weighted average assumptions:
60
2006
|
2005
|
|||||||
Expected
term (in years)
|
5.4 | 5.7 | ||||||
Risk-free
interest rate (%)
|
4.8 | % | 3.7 | % | ||||
Expected
volatility (%)
|
36 | % | 37 | % | ||||
Dividend
yield (%)
|
0.0 | % | 0.0 | % | ||||
Weighted
average fair value/share at grant date
|
$ | 0.23 | $ | 0.08 |
As a
result of adopting SFAS No. 123(R), the Company’s net loss for the year ended
December 31, 2006 was approximately $60,000 greater than if the Company had
continued to account for share-based compensation under Accounting Principles
Bulletin no. 25, “Accounting for Stock Issued to Employees” (“APB No.
25”). There were no effects on earnings per share as the result of
this adoption.
The
effect of recording stock-based compensation related to stock option grants
under the Plan in accordance with SFAS 123(R) for the year-ended December, 2006
was as follows:
2006
|
||||
Stock-based
compensation for employee stock options
|
$ | 63,730 | ||
Tax
effect on stock-based compensation
|
- | |||
Net
effect of stock-based compensation
|
$ | 63,730 | ||
Effect
on net loss per weighted average share
|
||||
Basic
|
$ | 0.00 | ||
Diluted
|
$ | 0.00 |
Periods
prior to the adoption of SFAS 123(R)
Prior to
January 1, 2006, we accounted for employee stock-based awards using the
intrinsic value method in accordance with APB 25, FASB Interpretation
No. 44 (“FIN 44”)
“Accounting for Certain Transactions Involving Stock-Based Compensation, an
Interpretation of APB Opinion No. 25”, FASB Technical Bulletin
No. 97-1 (“FTB 97-1”) “Accounting under Statement 123 for
Certain Employee Stock Purchase Plans with a Look-Back Option”, and
related interpretations. The Company accounted for non-employee
stock-based awards under the fair value method in accordance with EITF
No. 96-18 “ Accounting
for Equity Instruments that are Issued to Other than Employees for Acquiring, or
in Conjunction with Selling, Goods or Services”. Under the
intrinsic value method, no stock-based compensation expense for options had been
recognized in the Company’s Consolidated Statement of Operations if the exercise
price of the Company’s stock options granted to employees and directors equaled
the fair market value of the underlying stock at the date of grant.
Had
stock-based compensation for 2005 been determined based on the estimated fair
value at the grant date for all equity awards consistent with the provisions of
SFAS 123, the Company’s net income and earnings per share for the years ended
December 31, 2005 would have been adjusted to the following pro forma
amounts:
61
2005
|
||||
Net
loss, as reported
|
$ | (997,160) | ||
Add:
Stock-based compensation expense included in reported net earnings, net of
tax
|
2,953 | |||
Deduct:
Stock-based compensation expense determined under the fair value method,
net of tax
|
(57,162) | |||
Pro
forma, net loss
|
$ | (1,051,369) | ||
Basic
and Diluted net loss per weighted average share
|
||||
As
reported
|
$ | (0.04) | ||
Pro
forma
|
$ | (0.05) |
The
following table summarizes stock option activity under the Plan for the two
years ended December 31, 2006:
Number
Of
Shares
|
Weighted
Average
Exercise
Price
|
|||||||
Outstanding
at December 31, 2004
|
882,329 | $ | 0.16 | |||||
Granted
|
1,442,235 | 0.27 | ||||||
Exercised
|
(42,235 | ) | 0.00 | |||||
Canceled
|
(547,329 | ) | 0.11 | |||||
Outstanding
at December 31, 2005
|
1,735,000 | 0.27 | ||||||
Granted
|
1,011,897 | 0.68 | ||||||
Exercised
|
(211,814 | ) | 0.30 | |||||
Canceled
|
(428,083 | ) | 0.42 | |||||
Outstanding
at December 31, 2006
|
2,107,000 | 0.43 | ||||||
Exercisable
at December 31, 2006
|
1,161,416 | $ | 0.28 |
The
following table summarizes the information about stock options outstanding and
exercisable as of December 31, 2006:
Options
Outstanding, Expected to Vest
|
Options
Exercisable
|
Range of Exercise Prices | Number Outstanding | Weighted Average Remaining Contractual Life (Yrs) | Weighted Average Exercise Price | Number Exercisable | Weighted Average Remaining Contractual Life (Yrs) | Weighted Average Exercise Price | ||||||||||||||||||||
0.00 -
0.30
|
1,287,000
|
7.6
|
$ | 0.25 | 1,030,500 | 7.5 | $ | 0.25 | ||||||||||||||||||
0.31 - 0.46 | 179,250 | 8.6 | 0.35 | 82,166 | 8.5 | 0.35 | ||||||||||||||||||||
0.47 – 0.71 | 407,750 | 9.4 | 0.62 | 28,750 | 7.7 | 0.61 | ||||||||||||||||||||
0.47 – 0.71 | 85,000 | 9.7 | 0.99 | - | 0.0 | 0.00 | ||||||||||||||||||||
1.09 – 1.47 | 148,000 | 9.9 | 1.29 | 20,000 | 9.9 | 1.29 | ||||||||||||||||||||
2,107,000 | 8.3 | $ | 0.43 | 1,161,416 | 7.6 | $ | 0.28 |
62
As of
December 31, 2006, the aggregate intrinsic value of all stock options
outstanding and expected to vest was approximately $2.3 million and the
aggregate intrinsic value of currently exercisable stock options was
approximately $1.4 million. 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 29, 2006, the last trading day of
2006. The total number of in-the-money options outstanding and
exercisable as of December 31, 2006 was 1,161,416.
The total
intrinsic value of options exercised during the years ended December 31, 2006
and 2005 was approximately $215,000 and $0, 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 $63,000 and $0 for the years ended December 31, 2006 and
2005, respectively. No tax benefits were realized by the Company in
either 2006 or 2005 as a result of stock option exercises. The total
fair value of option shares vested during the years ended December 31, 2006
and 2005, was approximately $96,000 and $67,000, respectively.
As of
December 31, 2006, there was approximately $126,000 of total unrecognized
stock-based compensation cost, net of expected forfeitures, related to unvested
stock options granted under the Plan. This cost is expected to be
recognized over a weighted-average period of 2.3 years.
Employee Stock Purchase
Plan
On
October 31, 2006, our shareholders and Board of Directors approved an Employee
Stock Purchase Plan (“ESPP”) effective January 1, 2007. The ESPP as
approved stipulates that the rights to purchase shares granted under the plan be
considered options issued under an "employee stock purchase plan," as that term
is defined in Section 423(b) of the Code. The number of shares
reserved for issuance under the ESPP has been set to equal 1% of the Adjusted
Diluted Shares Outstanding (as defined above) at any given
time. Under the terms of the ESPP, the Board of Directors has been
authorized to set the parameters of any particular offering, provided, however,
that no rights to purchase shares may be offered to employees at a price which
is less than 95% of the fair market value of our common stock. The
Board of Directors has further delegated the authority to administer the ESPP to
the Compensation Committee and directed the Compensation Committee to ensure
that no offerings under the plan are compensable events under SFAS 123(R), which
effectively limits any offering period under the plan to 30 days. The
Company’s ESPP plan is considered exempt from fair value accounting under SFAS
No. 123R since the discount offered to employees is only 5%.
NOTE
F – COMMITMENTS AND CONTINGENCIES
Operating
Leases
In August
2003, we entered into a three year lease for 5,200 square feet at our laboratory
facility in Fort Myers, Florida. On June 29, 2006 we signed an
amendment to the original lease which extended the lease through June 30,
2011. The amendment included the rental of an additional 4,400 square
feet adjacent to our current facility. This space will allow
for future expansion of our business. The lease was further amended on January
17, 2007 but this amendment did not materially alter the terms of the lease,
which has total payments of approximately $653,000 over
63
the
remaining life of the lease, including annual increases of rental payments of 3%
per year. Such amount excludes estimated operating and maintenance
expenses and property taxes.
As part
of the acquisition of The Center for CytoGenetics, Inc. by the Company on April
18, 2006, we assumed the lease of an 850 square foot facility in Nashville,
Tennessee. The lease expires on August 31, 2008. The
average monthly rental expense is approximately $1,350 per
month. This space was not adequate for our future plans and the
Company is currently not using the facility and is actively trying to sublease
this facility. On June 15, 2006, we entered into a lease for a new
facility totaling 5,386 square feet of laboratory space in Nashville, Tennessee.
This space will be adequate to accommodate our current plans for the Tennessee
laboratory. As part of the lease, we have the right of first refusal on an
additional 2,420 square feet, if needed, directly adjacent to the
facility. The lease is a five year lease and results in total
payments by us of approximately $340,000.
On August
1, 2006, the Company entered into a lease for 1,800 square feet of laboratory
space in Irvine, California. The lease is a nine month lease and results in
total payments by the Company of approximately $23,000. This lease
will expire on April 30, 2007. We are currently in negotiations on a new larger
facility, which can accommodate our future growth.
Future
minimum lease payments under these leases as of December 31, 2006 are as
follows:
Years ending December
31,
|
Amounts
|
|||
2007
|
$ | 227,082 | ||
2008
|
219,471 | |||
2009
|
214,015 | |||
2010
|
219,907 | |||
2011
|
105,710 | |||
Total
minimum lease payments
|
$ | 986,185 |
Capital
Leases
During 2006, we entered into the
following capital leases:
Date
|
Type
|
Months
|
Cost
|
Monthly
Payment
|
Balance
at
December 31
|
|
March
2006
|
Laboratory
Equipment
|
60
|
$134,200
|
$2,692
|
$117,117
|
|
August
2006
|
Laboratory
Equipment
|
60
|
48,200
|
1,200
|
43,724
|
|
August
2006
|
Laboratory
Equipment
|
60
|
98,400
|
2,366
|
90,140
|
|
August
2006
|
Laboratory
Equipment
|
60
|
101,057
|
2,316
|
89,630
|
|
August
2006
|
Laboratory
Equipment
|
60
|
100,200
|
2,105
|
86,740
|
|
November
2006
|
Laboratory
Equipment
|
60
|
19,900
|
434
|
19,348
|
|
November
2006
|
Computer
Equipment
|
60
|
9,700
|
228
|
9,366
|
|
December
2006
|
Computer
Equipment
|
48
|
19,292
|
549
|
17,742
|
|
December
2006
|
Computer
Equipment
|
48
|
25,308
|
718
|
24,003
|
|
December
2006
|
Office
Equipment
|
60
|
46,100
|
994
|
45,567
|
|
Total
|
$602,357
|
$13,602
|
$543,377
|
Future
minimum lease payments under these leases as of December 31, 2006 are as
follows:
64
Years ending December
31,
|
Amounts
|
|||
2007
|
$ | 163,219 | ||
2008
|
163,219 | |||
2009
|
163,219 | |||
2010
|
161,951 | |||
2011
|
89,582 | |||
Total
future minimum lease payments
|
741,190 | |||
Less
amount representing interest
|
197,813 | |||
Present
value of future minimum lease payments
|
543,377 | |||
Less
current maturities
|
94,430 | |||
Obligations
under capital leases – long term
|
$ | 448,947 |
The
furniture and equipment covered under the lease agreements (see Note C) is
pledged as collateral to secure the performance of the future minimum lease
payments above.
Legal
Contingency
On
October 26, 2006, Accupath Diagnostics Laboratories, Inc. d/b/a US Labs (“US
Labs”) filed a complaint in the Superior Court of the State of California for
the County of Los Angeles naming as defendants the Company and its president,
Robert Gasparini. Also individually named are Company employees
Jeffrey Schreier, Maria Miller, Douglas White and Gary Roche.
The
complaint alleges the following causes of action: 1) Misappropriation
of Trade Secrets; 2) Tortious Interference with Prospective Economic Advantage;
3) Unfair Competition (Common Law); and 4) Unfair Competition (Cal. Bus. &
Prof. Code section 17200). The allegations are the result of the
Company's hiring four salespeople who were formerly employed by US
Labs. Specifically, US Labs alleges that the Company had access to
the US Labs salaries of the new hires, and was therefore able to obtain them as
employees.
US Labs
also sought broad injunctive relief against NeoGenomics preventing the Company
from doing business with its customers. US Labs requests were largely
denied, but the court did issue a much narrower preliminary injunction that
prevents NeoGenomics from soliciting the four new employees' former US Labs
customers until trial.
Discovery
commenced in December 2006. While the Company received unsolicited
and inaccurate salary information for three individuals that were ultimately
hired, no evidence of misappropriation of trade secrets has been discovered by
either side. As such, the Company is currently contemplating filing
motions to narrow or end the litigation, and expects to ultimately prevail at
trial.
We
believe that none of US Labs’ claims will be affirmed at trial; however, even if
they were, NeoGenomics does not believe such claims would result in a material
impact to our business. .
Purchase
Commitment
On June
22, 2006, we entered into an agreement to purchase three automated FISH signal
detection and analysis systems over the next 24 months for a total of
$420,000. We agreed to purchase two systems immediately and to
purchase a third system in the next 15 months if the vendor is able to make
certain improvements to its system. As of December 31, 2006, the
Company had purchased and installed 2 of the systems.
65
Employment
Contracts
On
December 14, 2004, we entered into an employment agreement with Robert P.
Gasparini to serve as our President and Chief Science Officer. The employment
agreement has an initial term of three years, effective January 3, 2005;
provided, however that either party may terminate the agreement by giving the
other party sixty days written notice. The employment agreement specifies an
initial base salary of $150,000/year, with specified salary increases to
$185,000/year over the first 18 months of the contract. Mr. Gasparini is also
entitled to receive cash bonuses for any given fiscal year in an amount equal to
15% of his base salary if he meets certain targets established by the Board of
Directors. In addition, Mr. Gasparini was granted 1,000,000 Incentive Stock
Options that have a ten year term so long as Mr. Gasparini remains an employee
of the Company (these options, which vest according to the passage of time and
other performance-based milestones, resulted in us recording stock based
compensation expense beginning in 2005). Mr. Gasparini's employment agreement
also specifies that he is entitled to four weeks of paid vacation per year and
other health insurance and relocation 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 employee benefits for a period of six
months.
NOTE
G- OTHER RELATED PARTY TRANSACTIONS
During
2006 and 2005, Steven C. Jones, a director of the Company, earned $71,000 and
$51,000, respectively, in cash for various consulting work performed in
connection with his duties as Acting Principal Financial Officer.
During
2006, George O’Leary, a director of the Company, earned $20,900 in cash for
various management consulting work performed for the Company.
On April
15, 2003, we entered into a revolving credit facility with MVP 3, LP (“MVP 3”,
which was subsequently renamed to Aspen Select Healthcare, LP), a partnership
controlled by certain of our shareholders. Under the terms of the
agreement MVP 3, LP agreed to make available to us up to $1.5 million of debt
financing with a stated interest rate of prime + 8% and such credit facility had
an initial maturity of March 31, 2005. At December 31, 2004, we owed
MVP 3, approximately $740,000 under this loan agreement. This
obligation was repaid in full through a refinancing on March 23,
2005.
On
February 18, 2005, we entered into a binding agreement with Aspen Select
Healthcare, LP (formerly known as MVP 3, LP) (“Aspen”) to refinance our existing
indebtedness of $740,000 and provide for additional liquidity of up to $760,000
to the Company. Under the terms of the agreement, Aspen, a Naples,
Florida-based private investment fund agreed to make available to us up to $1.5
million (subsequently increased to $1.7 million, as described below) of debt
financing in the form of a revolving credit facility (the “Credit Facility”)
with an initial maturity of March 31, 2007. Aspen is managed by its
General Partner, Medical Venture Partners, LLC, which is controlled by a
director of NeoGenomics. As part of this agreement, we also agreed to
issue to Aspen a five year warrant to purchase up to 2,500,000 shares of common
stock at an initial exercise price of $0.50/share. An amended and
restated Loan Agreement for the Credit Facility and other ancillary documents,
including the warrant agreement, which more formally implemented the agreements
made on February 18, 2005 were executed on March 23, 2005. All
material terms were identical to the February 18, 2005 agreement. We
incurred $53,587 of transaction
expenses in connection with refinancing the Credit Facility, which have been
capitalized and are being amortized to interest expense over the term of the
agreement.
66
We
recorded $131,337 for the value of such Warrant as of the February 18, 2005
measurement date as a discount to the face amount of the Credit
Facility. The Company is amortizing such discount to interest expense
over the 24 months of the Credit Facility. The fair value of the
warrants issued to Aspen was determined using the Black Scholes option valuation
model, based on the following factors, which were present on the measurement
date for such warrants:
Strike price | $ | 0.50 | ||
Market price | $ | 0.35 | ||
Term |
5
years
|
|||
Volatility | 22.7 | % | ||
Risk-free rate | 4.50 | % | ||
Dividend yield | 0 | % | ||
Warrant value | $ | 0.0525347 | ||
# of warrants | 2,500,000 | |||
Total value | $ | 131,337 |
The total
value of the warrants of $131,337 was recorded as deferred financing costs and
is being amortized on a straight-line basis over the life of the credit
facility. As of December 31, 2006, $1,700,000 was available for use
and $1,675,000 had been drawn.
In
addition, as a condition to these transactions, the Company, Aspen and certain
individual shareholders agreed to amend and restate their shareholders’
agreement to provide that Aspen will have the right to appoint up to three of
seven of our directors and one mutually acceptable independent
director. We also entered into an amended and restated Registration
Rights Agreement, dated March 23, 2005 with Aspen and certain individual
shareholders, which grants to Aspen certain demand registration rights (with no
provision for liquidated damages) and which grants to all parties to the
agreement, piggyback registration rights.
On
January 18, 2006, the Company entered into a binding letter agreement (the
"Aspen Agreement") with Aspen Select Healthcare, LP, which provided, among other
things, that:
(a) Aspen
waived certain pre-emptive rights in connection with the sale of $400,000 of
common stock at a purchase price of $0.20/share and the granting of 900,000
warrants with an exercise price of $0.26/share to SKL Limited Partnership, LP
("SKL" as more fully described below) in exchange for five year warrants to
purchase 150,000 shares at an exercise price of $0.26/share (the “Waiver
Warrants”).
(b) Aspen
had the right, up to April 30, 2006, to purchase up to $200,000 of restricted
shares of the Company's common stock at a purchase price per share of
$0.20/share (1,000,000 shares) and receive a five year warrant to purchase
450,000 shares of the Company's common stock at an exercise price of $0.26/share
in connection with such purchase (the "Equity Purchase Rights"). On March 14,
2006, Aspen exercised its Equity Purchase Rights.
(c) Aspen
and the Company amended the Loan Agreement, dated March 23, 2005 (the "Loan
Agreement") between the parties to extend the maturity date until September 30,
2007 and to modify certain covenants (such Loan Agreement as amended, the
"Credit Facility Amendment").
67
(d)
Aspen had the right, until April 30, 2006, to provide up to $200,000 of
additional secured indebtedness to the Company under the Credit Facility
Amendment and to receive a five year warrant to purchase up to 450,000 shares of
the Company's common stock with an exercise price of $0.26/share (the "New Debt
Rights").On March 30, 2006, Aspen exercised its New Debt Rights and entered into
the definitive transaction documentation for the Credit Facility Amendment and
other such documents required under the Aspen Agreement.
(e) The
Company agreed to amend and restate the warrant agreement, dated March 23, 2005,
which more formally implemented the original agreement made on February 18, 2005
with respect to such warrants, to provide that all 2,500,000 warrant shares (the
"Existing Warrants") were vested and the exercise price per share was reset to
$0.31 per share. The difference between the value of the warrants on
the original February 18, 2005 measurement date which was calculated using an
exercise price of $0.50/share, and their value on the January 18, 2006
modification data which was calculated using an exercise price of $0.31/share,
amounted to $2,365 and was credited to additional paid-in capital and included
in deferred financing fees.
(f) The
Company agreed to amend the Registration Rights Agreement, dated March 23, 2005
(the "Registration Rights Agreement"), between the parties to incorporate the
Existing Warrants, the Waiver Warrants and any new shares or warrants issued to
Aspen in connection with the Equity Purchase Rights or the New Debt
Rights.
(g) All
Waiver Warrants, the Existing Warrants and all warrants issued to Aspen and SKL
in connection with the purchase of equity or debt securities are exercisable at
the option of the holder for a term of five years, and each such warrant
contains provisions that allow for a physical exercise, a net cash exercise or a
net share settlement. We used the Black-Scholes pricing model to
estimate the fair value of all such warrants as of the measurement date for
each, using the following approximate assumptions: dividend yield of 0 %,
expected volatility of 14.6 – 19.3% (depending on the measurement date),
risk-free interest rate of 4.5%, and a term or expected life of 3 - 5
years.
During
the period from January 18 - 21, 2006, the Company entered into agreements with
four other shareholders who are parties to the certain Shareholders’ Agreement
dated March 23, 2005, to exchange five year warrants to purchase an aggregate of
150,000 shares of stock at an exercise price of $0.26/share for such
shareholders’ waiver of their pre-emptive rights under the Shareholders’
Agreement.
On
January 21, 2006 the Company entered into a subscription agreement (the
"Subscription") with SKL Family Limited Partnership, LP, a New Jersey limited
partnership, whereby SKL purchased 2.0 million shares (the "Subscription
Shares") of the Company's common stock at a purchase price of $0.20/share for
$400,000. Under the terms of the Subscription, the Subscription Shares are
restricted for a period of 24 months and then carry piggyback registration
rights to the extent that exemptions under Rule 144 are not available to SKL. In
connection with the Subscription, the Company also issued a five year warrant to
purchase 900,000 shares of the Company's common stock at an exercise price of
$0.26/share. SKL has no previous affiliation with the
Company.
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, our Chairman. Under the terms of the
68
agreement,
the Company paid $22,500 over three months to customize this software and will
pay an annual membership fee of $6,000 per year and monthly transaction fees of
between $2.50 - $10.00 per completed test, depending on the volume of tests
performed. The eTelenext system is an elaborate laboratory
information system (LIS) that is in use at many larger
laboratories. By assisting in the formation of the small laboratory
network, the Company will be able to increase the productivity of its
technologists and have on-line links to other small laboratories in the network
in order to better manage its workflow.
NOTE
H – EQUITY FINANCING TRANSACTIONS
On
January 3, 2005, we issued 27,288 shares of common stock under the Company’s
2003 Equity Incentive Plan to two employees of the Company in satisfaction of
$6,822 of accrued, but unpaid, vacation.
During
the period from January 1, 2005 to May 31, 2005, we sold 522,382 shares of our
common stock in a series of private placements at $0.30 per share and $0.35 per
share to unaffiliated third party investors. These transactions generated net
proceeds to the Company of approximately $171,000.
On June
6, 2005, we entered into a Standby Equity Distribution Agreement with Cornell
Capital Partners, LP (“Cornell”). Pursuant to the Standby Equity
Distribution Agreement, the Company may, at its discretion, periodically sell to
Cornell shares of common stock for a total purchase price of up to $5.0
million. For each share of common stock purchased under the Standby
Equity Distribution Agreement, Cornell will pay the Company 98% of the lowest
volume weighted average price (“VWAP”) of the Company’s common stock as quoted
by Bloomberg, LP on the Over-the-Counter Bulletin Board or other principal
market on which the Company’s common stock is traded for the 5 days immediately
following the notice date (the “Purchase Price”). The total number of
shares issued to Cornell under each advance request will be equal to the total
dollar amount of the advance request divided by the Purchase Price determined
during the five day pricing period. Cornell will also retain 5% of
each advance under the Standby Equity Distribution
Agreement. Cornell’s obligation to purchase shares of the Company’s
common stock under the Standby Equity Distribution Agreement is subject to
certain conditions, including the Company maintaining an effective registration
statement for shares of common stock sold under the Standby Equity Distribution
Agreement and is limited to $750,000 per weekly advance. The amount
and timing of all advances under the Standby Equity Distribution Agreement are
at the discretion of the Company and the Company is not obligated to issue and
sell any securities to Cornell, unless and until it decides to do
so. Upon execution of the Standby Equity Distribution Agreement,
Cornell received 381,888 shares of the Company’s common stock as a commitment
fee under the Standby Equity Distribution Agreement. The Company also
issued 27,278 shares of the Company’s common stock to Spartan Securities Group,
Ltd. under a placement agent agreement relating to the Standby Equity
Distribution Agreement.
On July
28, 2005, we filed an amended SB-2 registration statement with the Securities
and Exchange Commission to register 10,000,000 shares of our common stock
related to the Standby Equity Distribution Agreement. Such
registration statement became effective as of August 1, 2005.
On June
6, 2006 as a result of not terminating our Standby Equity Distribution Agreement
with Cornell, a short-term note payable in the amount of $50,000 became due to
Cornell and was subsequently paid in July 2006.
69
The
following sales of common stock have been made under our Standby Equity
Distribution Agreement with Cornell since it was first declared effective on
August 1, 2005.
Request
|
Completion
|
Shares
of
|
Gross
|
Cornell
|
Escrow
|
Net
|
|||||||||||||||||||
Date
|
Date
|
Common
Stock
|
Proceeds
|
Fee
|
Fee
|
Proceeds
|
ASP(1)
|
||||||||||||||||||
8/29/2005
|
9/8/2005
|
63,776 | $ | 25,000 | $ | 1,250 | $ | 500 | $ | 23,250 | |||||||||||||||
12/10/2005
|
12/18/2005
|
241,779 | 50,000 | 2,500 | 500 | 47,000 | |||||||||||||||||||
Subtotal
– 2005
|
305,555 | $ | 75,000 | $ | 3,750 | $ | 1,000 | $ | 70,250 | $ | 0.25 | ||||||||||||||
7/19/2006
|
7/28/2006
|
83,491 | 53,000 | 2,500 | 500 | 50,000 | |||||||||||||||||||
8/8/2006
|
8/16/2006
|
279,486 | 250,000 | 12,500 | 500 | 237,000 | |||||||||||||||||||
10/18/2006
|
10/23/2006
|
167,842 | 200,000 | 10,000 | 500 | 189,500 | |||||||||||||||||||
Subtotal
– 2006
|
530,819 | $ | 503,000 | $ | 25,000 | $ | 1,500 | $ | 476,500 | $ | 0.95 | ||||||||||||||
12/29/2006
|
1/10/2007
|
98,522 | 150,000 | 7,500 | 500 | 142,000 | |||||||||||||||||||
1/16/2007
|
1/24/2007
|
100,053 | 150,000 | 7,500 | 500 | 142,000 | |||||||||||||||||||
2/1/2007
|
2/12/2007
|
65,902 | 100,000 | 5,000 | 500 | 94,500 | |||||||||||||||||||
2/19/2007
|
2/28/2007
|
166,611 | 250,000 | 12,500 | 500 | 237,000 | |||||||||||||||||||
2/28/2007
|
3/7/2007
|
180,963 | 250,000 | 12,500 | 500 | 237,000 | |||||||||||||||||||
Subtotal
– 2007 YTD
|
612,051 | $ | 900,000 | $ | 45,000 | $ | 2,500 | $ | 852,500 | $ | 1.47 | ||||||||||||||
Total Since
Inception
|
1,448,425 | $ | 1,478,000 | $ | 73,750 | $ | 5,000 | $ | 1,399,250 | $ | 1.02 | ||||||||||||||
Remaining
|
- | $ | 3,522,000 | - | - | - | |||||||||||||||||||
Total
Facility
|
- | $ | 5,000,000 | - | - | - | |||||||||||||||||||
(1) Average
Selling Price of shares issued
On July
1, 2005, we issued 14,947 shares of our common stock under the Company’s 2003
Equity Incentive Plan to two employees of the Company in satisfaction of $4,933
of accrued, but unpaid vacation.
On
December 15, 2005, we issued 18,000 shares of common stock under the Company’s
2003 Equity Incentive Plan to employees of the Company as part of a year-end
bonus program. The shares were issued at a price of $0.21/share and
resulted in an expense to the Company of $3,780.
On
January 18, 2006, the Company entered into a binding letter agreement (the
"Aspen Agreement") with Aspen Select Healthcare, LP, as described in Note
G.
70
During
the period from January 18 - 21, 2006, the Company entered into agreements with
four other shareholders who are parties to that certain Shareholders’ Agreement,
dated March 23, 2005, to exchange five year warrants to purchase an aggregate of
150,000 shares of stock at an exercise price of $0.26/share for such
shareholders’ waiver of their pre-emptive rights under the Shareholders’
Agreement.
On
January 21, 2006 the Company entered into a subscription agreement (the
"Subscription") with SKL Family Limited Partnership, LP, a New Jersey limited
partnership, whereby SKL purchased 2.0 million shares (the "Subscription
Shares") of the Company's common stock at a purchase price of $0.20/share for
$400,000. Under the terms of the Subscription, the Subscription Shares are
restricted for a period of 24 months and then carry piggyback registration
rights to the extent that exemptions under Rule 144 are not available to SKL. In
connection with the Subscription, the Company also issued a five year warrant to
purchase 900,000 shares of the Company's common stock at an exercise price of
$0.26/share. SKL has no previous affiliation with the
Company.
NOTE
I – SUBSEQUENT EVENT
On April
2, 2007, we concluded an agreement with Power3 Medical Products, Inc., a New
York Corporation (“Power3”) regarding the formation of a joint venture Contract
Research Organization (“CRO”) and the issuance of convertible debentures and
related securities by Power3 to us. Power3 is an early stage company
engaged in the discovery, development, and commercialization of protein
biomarkers. Under the terms of the agreement, NeoGenomics and Power3
will jointly own a CRO and begin commercializing Power3’s intellectual property
portfolio of 17 patents pending by developing diagnostic tests and other
services around one or more of the 523 protein biomarkers that Power3 believes
it has discovered to date. Power3 has agreed to license all of its
intellectual property on a non-exclusive basis to the CRO for selected
commercial applications as well as provide certain management
personnel. We will provide access to cancer samples, management and
sales & marketing personnel, laboratory facilities and working
capital. Subject to final negotiation, we will own a minimum of 60%
and up to 80% of the new CRO venture which is anticipated to be launched in the
third or fourth quarter of FY 2007.
As part
of the agreement, we will provide $200,000 of working capital to Power3 by
purchasing a convertible debenture on or before April 16, 2007. We
were also granted two options to increase our stake in Power3 to up to 60% of
the Power3 fully diluted shares outstanding. The first option (the
“First Option”) is a fixed option to purchase convertible preferred stock of
Power3 that is convertible into such number of shares of Power3 common stock, in
one or more transactions, up to 20% of Power3’s voting common stock at a
purchase price per share, which will also equal the initial conversion price per
share, equal to the lesser of a) $0.20/share, or b) an equity valuation of
$20,000,000 divided by the fully-diluted shares outstanding on the date of the
exercise of the First Option. This 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 a) November 16,
2007 or b) the date that certain milestones specified in the agreement have been
achieved. The First Option is exercisable in cash or NeoGenomics
common stock at our option, provided, however, that we must include at least
$1.0 million of cash in the consideration if we elect to exercise this First
Option. In addition to purchasing convertible preferred stock as part
of the First Option, we are also entitled to receive that number of warrants
which is equal to the same percentage as the percentage of convertible preferred
stock being purchased on such day of Power3’s warrants and options
.. Such warrants will have an exercise price equal to the initial
conversion price of the convertible preferred stock that was
purchased and will have a five year term.
71
The
second option (the “Second Option”), which is only exercisable to the extent
that we have exercised the First Option, provides that we will have the option
to increase our stake in Power3 to up to 60% of fully diluted shares of Power3
over the twelve month period beginning on the expiration date of the First
Option in one or a series of transactions by purchasing additional convertible
preferred stock of Power3 that is convertible into voting common stock and
receiving additional warrants. The purchase price per share, and the
initial conversion price of the Second Option convertible preferred stock will,
to the extent such Second Option is exercised within six (6) months of exercise
of the First Option, be the lesser of a) $0.40/share or b) an equity price per
share equal to $40,000,000 divided by the fully diluted shares outstanding on
the date of any purchase. The purchase price per share, and the
initial conversion price of the Second Option convertible preferred stock will,
to the extent such Second Option is exercised after six (6) months, but within
twelve (12) months of exercise of the First Option, be the lesser of a)
$0.50/share or b) an equity price per share equal to $50,000,000 divided by the
fully diluted shares outstanding on the date of any
purchase. The exercise price of the Second Option may be paid
in cash or in any combination of cash and our common stock at our
option. In addition to purchasing convertible preferred stock as part
of the Second Option, we are also entitled to receive that number of warrants
which is equal to the same percentage as the percentage of convertible preferred
stock being purchased on such day of Power3’s warrants and
options. Such warrants will have an exercise price equal to the
initial conversion price of the convertible preferred stock being purchased that
date and will have a five year term.
End of
Financial Statements
72
ITEM
8.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
Not
applicable.
ITEM
8A. CONTROLS
AND PROCEDURES
(A) Evaluation
Of Disclosure Controls And Procedures
As of the
end of the period covered by this report, the Company carried out an evaluation,
under the supervision and with the participation of the Company’s Principal
Executive Officer, Principal Accounting Officer and Acting Principal Financial
Officer of the effectiveness of the design and operation of the Company’s
disclosure controls and procedures. The Company’s disclosure controls
and procedures are designed to provide a reasonable level of assurance of
achieving the Company’s disclosure control objectives. The Company’s Principal
Executive Officer and Acting Principal Financial Officer have concluded that the
Company’s disclosure controls and procedures are, in fact, effective at this
reasonable assurance level as of the period covered. In addition, the
Company reviewed its internal controls, and there have been no significant
changes in its internal controls or in other factors that could significantly
affect those controls subsequent to the date of their last evaluation or from
the end of the reporting period to the date of this
Form 10-KSB/A.
(B) Changes
In Internal Controls Over Financial Reporting
In
connection with the evaluation of the Company’s internal controls during the
Company’s fourth fiscal quarter ended December 31, 2006, the Company’s Principal
Executive Officer, Principal Accounting Officer and Acting Principal Financial
Officer have determined that there are no changes to the Company’s internal
controls over financial reporting that has materially affected, or is reasonably
likely to materially effect, the Company’s internal controls over financial
reporting.
73
PART
III
ITEM
9.
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTORS AND CONTROL PERSONS; COMPLIANCE WITH SECTION
16(a) OF THE EXCHANGE ACT
|
The
following table sets forth certain information regarding our members of the
Board of Directors and other executives as of March 15, 2007:
Name
|
Age
|
Position
|
Board of Directors:
|
||
Robert
P. Gasparini
|
52
|
President
and Chief Science Officer,
Board
Member
|
Steven
C. Jones
|
43
|
Acting
Principal Financial Officer,
Board
Member
|
Michael
T. Dent
|
42
|
Chairman
of the Board
|
George
G. O’Leary
|
44
|
Board
Member
|
Peter
M. Peterson
|
50
|
Board
Member
|
Other Executives:
|
||
Robert
J. Feeney
|
39
|
Vice
President of Sales and Marketing
|
Matthew
William Moore
|
33
|
Vice
President of Research and Development
|
Jerome
J. Dvonch
|
38
|
Principal
Accounting Officer
|
There are
no family relationships between or among the members of the Board of Directors
or other executives. With the exception of Mr. Peterson, the
directors and other executives of the Company are not directors or executive
officers of any company that files reports with the SEC. Mr. Peterson
also serves as Chairman of the Board of Innovative Software Technologies, Inc.
(OTC BB: INIV). 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 the Company’s 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.
Members of the Company’s Board of
Directors are elected at the annual meeting of stockholders and hold office
until their successors are elected. The Company’s 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.
Robert P. Gasparini, M.S. –
President and Chief Science Officer, Board Member
Mr.
Gasparini is the President and Chief Science Officer of
NeoGenomics. Prior to assuming the role of President and Chief
Science Officer, Mr. Gasparini was a consultant to the Company since 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
74
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 Mass
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 – Acting
Principal Financial Officer, Board Member
Mr. Jones
has served as a director since October 2003. 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 from the Wharton School of the
University of Pennsylvania in 1991. He is also Chairman of the Board of Quantum
Health Systems, LLC and T3 Communications, LLC.
Michael T. Dent M.D. –
Chairman of the Board
Dr. Dent
is our founder and Chairman of the Board. 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, S.C. in 1992 and a B.S. degree from Davidson College in Davidson,
N.C. 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. 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 VP 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.
75
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. Mr. Peterson
is also the Chairman and Founder of CleanFuel USA and the Chairman of Innovative
Software Technologies (OTCBB: INIV). 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. Previous 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.
Robert J. Feeney, Ph.D – Vice
President of Sales and Marketing
Mr. Feeney has served as Vice President
of Sales and Marketing since January 3, 2007. Prior to NeoGenomics,
he served in a dual capacity as the Director of Marketing and the Director of
Scientific & Clinical Affairs for US Labs, a division of Laboratory
Corporation of America (LabCorp). Prior to that, Dr. Feeney held a
variety of roles including the National Manager of Clinical Affairs and the
Central Regional Sales Manager position where he managed up to 33% of the sales
force. In his first full year with US Labs, he grew revenue from $1
million to $17 million in this geography. Prior to US Labs, Dr. Feeney was
employed with Eli Lilly and Company as an Associate Marketing Manager and with
Impath Inc., now a wholly owned division of Genzyme Genetics, where he held
various positions including Regional Sales Manager and District Sales Manager
assignments. Dr. Feeney has over 14 years of sales and marketing
experience with 17 years in the medical industry. Dr. Feeney received
his Bachelors of Science degree in Biology from Dickinson College and his
doctoral degree in Cellular and Developmental Biology from the State University
of New York.
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
76
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 has extensive experience in strategic
planning, SEC reporting and accounting in the life science
industry. He also has experience in mergers and acquisitions and with
debt/equity financing transactions. 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.
Audit
Committee
Currently, the Company’s Audit
Committee of the Board of Directors is comprised of Steven C. Jones and George
O’Leary. The Board of Directors believes that both Mr. Jones and Mr.
O’Leary are “financial experts” (as defined in Regulation 228.401(e)(1)(i)(A) of
Regulation S-B). Mr. Jones is a Managing Member of Medical Venture
Partners, LLC, which serves as the general partner of Aspen Select Healthcare
LP, a partnership which controls approximately 36.1% of the voting stock of the
Company. Thus Mr. Jones would not be considered an “independent”
director under Item 7(d)(3)(iv) of Schedule 14A of the Securities Exchange Act
of 1934 (the “Act”). However, Mr. O’Leary would be considered an
“independent” director under Item 7(d)(3)(iv) of Schedule 14A of the
Act.
Compensation
Committee
Currently,
the Company’s Compensation Committee of the Board of Directors is comprised of
the Board Members except for Mr. Gasparini.
Code
of Ethics
The
Company adopted a Code of Ethics for its senior financial officers and the
principal executive officer during 2004 as published in our 10-KSB dated April
15, 2005.
ITEM
10.
|
EXECUTIVE
COMPENSATION
|
The
following table provides certain summary information concerning compensation
paid by the Company to or on behalf of our most highly compensated executive
officers for the fiscal years ended December 31, 2006, 2005, and
2004:
77
Summary
Compensation Table
Name
and Principal Capacity
|
Year
|
Salary
|
Other
Compensation
|
|||||||||||||
Robert
P. Gasparini
President
& Chief Science Officer
|
2006
2005
2004
|
$ |
183,500
$162,897
$ 22,500
|
(3) | $ |
87,900
$28,128
--
|
(1)
(2)
|
|||||||||
Jerome
Dvonch
Principal
Accounting Officer
|
2005
2004
2003
|
$ |
92,846
$ 35,890
-
|
$ |
20,850
13,441
-
|
(4)
(5)
|
||||||||||
Steven
Jones
Acting
Principal Financial Officer and Director
|
2006
2005
2004
|
$ |
71,000
$ 51,000
$ 72,500
|
(6)
(6)
(6)
|
-
-
-
|
|
(1)Mr.
Gasparini had other income from the exercise of 90,000 stock
options.
|
|
(2)Mr.
Gasparini moved to Florida from California during 2005 and this represents
his relocation expenses paid by the
Company.
|
|
(3)Mr.
Gasparini was appointed as President and Chief Science Officer on January
3, 2005. During 2004, he acted as a consultant to the Company
and the amounts indicated represent his consulting
income.
|
|
(4)Mr.
Dvonch had other income from the exercise of 15,000 stock
options.
|
|
(5)Mr.
Dvonch moved to Florida from California during 2005 and this represents
his relocation expenses paid by the
Company.
|
|
(6)Mr.
Jones has acted as a consultant to the Company and the amounts indicated
represent his consulting income.
|
78
ITEM
11. SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth information as of March 29, 2007, 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.
Title
of
Class
|
Name
And Address Of Beneficial Owner
|
Amount
and Nature Of Beneficial Ownership
|
Percent
Of Class(1)
|
||||||
Common
|
Aspen
Select Healthcare, LP (2)
1740
Persimmon Drive
Naples,
Florida 34109
|
13,553,279 | 43.38 | % | |||||
Common
|
Steven
C. Jones (3)
1740
Persimmon Drive
Naples,
Florida 34109
|
14,110,577 | 45.12 | % | |||||
Common
|
Michael
T. Dent M.D. (4)
1726
Medical Blvd.
Naples,
Florida 34110
|
2,731,492 | 9.70 | % | |||||
Common
|
George
O’Leary (5)
6506
Contempo Lane
Boca
Raton, Florida 33433
|
200,000 | 0.72 | % | |||||
Common
|
Robert
P. Gasparini (6)
20205
Wildcat Run
Estero,
FL 33928
|
712,500 | 2.46 | % | |||||
Common
|
Peter
M. Peterson (7)
2402
S. Ardson Place
Tampa,
FL 33629
|
13,553,279 | 43.38 | % | |||||
Common
|
SKL
Family Limited Partnership (8)
984
Oyster Court
Sanibel,
FL 33957
|
2,900,000 | 10.14 | % | |||||
Common
|
Robert
J. Feeney
7359
Fox Hollow Ridge
Zionsville,
IN 46077
|
15,625 | - | ||||||
Common
|
Matthew
W. Moore
3751
Pine Street
Irvine,
Ca 92606
|
14,375 | |||||||
Common
|
Jerome
J. Dvonch
11169
Lakeland Circle
Fort
Myers, FL 33913
|
38,416 | - | ||||||
Common
|
Directors
and Officers as a Group (2 persons)
|
17,754,569 | 54.39 | % |
(1) Beneficial
ownership is determined in accordance within the rules of the Commission and
generally includes voting of investment power with respect to
securities. Shares of common stock subject to securities exercisable
or convertible into shares of common stock that are currently exercisable or
exercisable within 60 days of March 29, 2006 are deemed to be beneficially owned
by the person holding such options for the purpose of computing the percentage
of ownership of such persons, but are not treated as outstanding for the purpose
of computing the percentage ownership of any other person.
79
(2) Aspen
Select Healthcare, LP (“Aspen”) has direct ownership of 10,003,279 shares and
has certain warrants with 3,550,000 shares currently exercisable. The
general partner of Aspen is Medical Venture Partners, LLC, an entity controlled
by Steven C. Jones.
(3) Steven
C. Jones, director of the Company, has direct ownership of 530,000 shares and
currently exercisable warrants to purchase an additional 27,298 shares, but as a
member of the general partner of Aspen, he has the right to vote all shares held
by Aspen, thus 10,533,279 shares and 3,577,298 currently exercisable warrant
shares have been added to his total.
(4) Michael
T. Dent, a director of the Company, has direct ownership of 2,258,535 shares,
currently exercisable warrants to purchase 72,992 shares, and currently
exercisable options to purchase 400,000 shares.
(5) George
O’Leary, a director of the Company, has direct ownership of 200,000 warrants, of
which 150,000 are currently exercisable. He also has options to
purchase 50,000 shares, of which 50,000 shares are currently
exerciseable.
(6) Robert
Gasparini, President of the Company, has direct ownership of 15,000 shares, and
has 935,000 options to purchase shares, of which 697,500 are currently
exercisable.
(7) Peter
M. Peterson is a member of the general partner of Aspen and has the right to
vote all shares held by Aspen. Thus 10,003,279 shares and 3,550,000
currently exercisable warrant shares have been added to his
total. Mr. Peterson does not own any other stock of the Company
except through his affiliation with Aspen.
(8) SKL
Family Limited Partnership has direct ownership of 2,000,000 shares and
currently exercisable warrants to purchase 900,000 shares.
(9) Robert
J. Feeney, Vice President of Sales and Marketing, has 275,000 options to
purchase shares, of which 15,625 are currently exercisable.
(10) Matthew
W. Moore, Vice President of Research and Development, has 105,000 options to
purchase shares, of which 14,375 are currently exercisable.
(11) Jerome
J. Dvonch, Principal Accounting Officer, has 150,000 options to purchase shares,
of which 38,416 shares are currently exercisable.
ITEM
12. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
During
2006 and 2005, Steven C. Jones, a director of the Company, earned $70,667 and
$51,000, respectively, in cash for various consulting work performed connection
with his duties as Acting Principle Financial Officer.
During
2006, George O’Leary, a director of the Company, earned $20,900 in cash for
management consulting work performed for the Company.
On
January 18, 2006, George O’Leary, a director received from the Company 50,000
incentive stock options at $0.26 per share in compensation for services related
to the Equity and Debt Financing the company completed in January
2006.
80
On April
15, 2003, we entered into a revolving credit facility with MVP 3, LP (“MVP 3”,
which was subsequently renamed to Aspen Select Healthcare, LP), a partnership
controlled by certain of our shareholders. Under the terms of the
agreement MVP 3, LP agreed to make available up to $1.5 million of debt
financing with a stated interest rate of prime + 8% and such credit facility had
an initial maturity of March 31, 2005. At December 31, 2004, we owed
MVP 3, approximately $740,000 under this loan agreement. This
obligation was repaid in full through a refinancing on March 23,
2005.
On
February 18, 2005, we entered into a binding agreement with Aspen Select
Healthcare, LP (formerly known as MVP 3, LP) (“Aspen”) to refinance our existing
indebtedness of $740,000 and provide for additional liquidity of up to $760,000
to the Company. Under the terms of the agreement, Aspen, a Naples,
Florida-based private investment fund agreed to make available up to $1.5
million (subsequently increased to $1.7 million, as described below) of debt
financing in the form of a revolving credit facility (the “Credit Facility”)
with an initial maturity of March 31, 2007. Aspen is managed by its
General Partner, Medical Venture Partners, LLC, which is controlled by a
director of NeoGenomics. As part of this agreement, we also agreed to
issue to Aspen a five year warrant to purchase up to 2,500,000 shares of common
stock at an initial exercise price of $0.50/share. An amended and
restated Loan Agreement for the Credit Facility and other ancillary documents,
including the warrant agreement, which more formally implemented the agreements
made on February 18, 2005 were executed on March 23, 2005. All
material terms were identical to the February 18, 2005 agreement.
We
incurred $53,587 of transaction expenses in connection with refinancing the
Credit Facility, which have been capitalized and are being amortized to interest
expense over the life of the Credit Facility. We recorded $131,337
for the value of the Warrants as of the February 18, 2005 measurement date as a
discount to the face amount of the Credit Facility. The Company is
amortizing such discount to interest expense over the life of the Credit
Facility. As of December 31, 2005, $1,700,000 was available for use
and $1,675,000 had been drawn.
On
January 18, 2006, the Company entered into a binding letter agreement (the
"Aspen Agreement") with Aspen Select Healthcare, LP, which provided, among other
things, that:
(a) Aspen
waived certain pre-emptive rights in connection with the sale of $400,000 of
common stock at a purchase price of $0.20/share and the granting of 900,000
warrants with an exercise price of $0.26/share to SKL Limited Partnership, LP
("SKL" as more fully described below) in exchange for five year warrants to
purchase 150,000 shares at an exercise price of $0.26/share (the “Waiver
Warrants”).
(b) Aspen
had the right, up to April 30, 2006, to purchase up to $200,000 of restricted
shares of the Company's common stock at a purchase price per share of
$0.20/share (1,000,000 shares) and receive a five year warrant to purchase
450,000 shares of the Company's common stock at an exercise price of $0.26/share
in connection with such purchase (the "Equity Purchase Rights"). On March 14,
2006, Aspen exercised its Equity Purchase Rights.
(c) Aspen
and the Company amended the Loan Agreement, dated March 23, 2005 (the "Loan
Agreement") between the parties to extend the maturity date until September 30,
2007 and to modify certain covenants (such Loan Agreement as amended, the
"Credit Facility Amendment").
81
(d)
Aspen had the right, until April 30, 2006, to provide up to $200,000 of
additional secured indebtedness to the Company under the Credit Facility
Amendment and to receive a five year warrant to purchase up to 450,000 shares of
the Company's common stock with an exercise price of $0.26/share (the "New Debt
Rights").On March 30, 2006, Aspen exercised its New Debt Rights and entered into
the definitive transaction documentation for the Credit Facility Amendment and
other such documents required under the Aspen Agreement.
(e) The
Company agreed to amend and restate the warrant agreement, dated March 23, 2005,
which more formally implemented the original agreement made on February 18, 2005
with respect to such warrants, to provide that all 2,500,000 warrant shares (the
"Existing Warrants") were vested and the exercise price per share was reset to
$0.31 per share.
(f) The Company agreed to amend the
Registration Rights Agreement, dated March 23, 2005 (the "Registration Rights
Agreement"), between the parties to incorporate the Existing Warrants, the
Waiver Warrants and any new shares or warrants issued to Aspen in connection
with the Equity Purchase Rights or the New Debt Rights.
We
borrowed an additional $100,000 from the Aspen credit facility in May 2006,
$25,000 in September 2006 and $50,000 in December 2006. At December
31, 2006, $1,675,000 was outstanding on the credit facility, which bears
interest at prime plus 6%, and $25,000 remained available. Subsequent
to December 31, 2006 we borrowed the remaining $25,000 available under the Aspen
Facility.
During the period from January 18 - 21,
2006, the Company entered into agreements with four other shareholders who are
parties to a Shareholders’ Agreement, dated March 23, 2005, to exchange five
year warrants to purchase an aggregate of 150,000 shares of stock at an exercise
price of $0.26/share for such shareholders’ waiver of their pre-emptive rights
under the Shareholders’ Agreement.
On January 21, 2006 the Company entered
into a subscription agreement (the "Subscription") with SKL Family Limited
Partnership, LP, a New Jersey limited partnership, whereby SKL purchased 2.0
million shares (the "Subscription Shares") of the Company's common stock at a
purchase price of $0.20/share for $400,000. Under the terms of the Subscription,
the Subscription Shares are restricted for a period of 24 months and then carry
piggyback registration rights to the extent that exemptions under Rule 144 are
not available to SKL. In connection with the Subscription, the Company also
issued a five year warrant to purchase 900,000 shares of the Company's common
stock at an exercise price of $0.26/share. SKL has no previous
affiliation with the Company.
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, our Chairman. By becoming the first customer of HCSS
in the small laboratory network, the Company saved approximately $152,000 in up
front licensing fees. Under the terms of the agreement, the Company
paid $22,500 over three months to customize this software and will pay an annual
membership fee of $6,000 per year and monthly transaction fees of between $2.50
- - $10.00 per completed test, depending on the volume of tests
performed. The eTelenext system is an elaborate laboratory
information system (LIS) that is in use at many larger labs. By
assisting in the formation of the small laboratory network, the Company will be
able to increase the productivity of its technologists and have on-line links to
other small labs in the network in order to better manage its
workflow.
82
PART
IV
ITEM
13.
|
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM
8-K
|
(a) Exhibits
EXHIBIT
NO.
|
DESCRIPTION
|
FILING
REFERENCE
|
3.1
|
Articles
of Incorporation, as amended
|
(i)
|
3.2
|
Amendment
to Articles of Incorporation filed with the Nevada Secretary of State on
January 3, 2003.
|
(ii)
|
3.3
|
Amendment
to Articles of Incorporation filed with the Nevada Secretary of State on
April 11, 2003.
|
(ii)
|
3.4
|
Amended
and Restated Bylaws, dated April 15, 2003.
|
(ii)
|
10.1
|
Amended
and Restated Loan Agreement between NeoGenomics, Inc. and Aspen Select
Healthcare, L.P., dated March 30, 2006
|
(iii)
|
10.2
|
Amended
and Restated Registration Rights Agreement between NeoGenomics, Inc. and
Aspen Select Healthcare, L.P. and individuals dated March 23,
2005
|
(iv)
|
10.3
|
Guaranty
of NeoGenomics, Inc., dated March 23, 2005
|
(iv)
|
10.4
|
Stock
Pledge Agreement between NeoGenomics, Inc. and Aspen Select Healthcare,
L.P., dated March 23, 2005
|
(iv)
|
10.5
|
Amended
and Restated Warrant Agreement between NeoGenomics, Inc. and Aspen Select
Healthcare, L.P., dated January 21, 2006
|
(iii)
|
10.6
|
Amended
and Restated Security Agreement between NeoGenomics, Inc. and Aspen Select
Healthcare, L.P., dated March 30, 2006
|
(iii)
|
10.7
|
Employment
Agreement, dated December 14, 2005, between Mr. Robert P. Gasparini and
the Company
|
(v)
|
10.8
|
Registration
Rights Agreement between NeoGenomics, Inc. and Aspen Select Healthcare,
L.P., dated March 30, 2006
|
(iii)
|
10.9
|
Warrant
Agreement between NeoGenomics, Inc. and SKL Family Limited Partnership,
L.P. issued January 23, 2006
|
(iii)
|
10.10
|
Warrant
Agreement between NeoGenomics, Inc. and Aspen Select Healthcare, L.P.
issued March 14, 2006
|
(iii)
|
10.11
|
Warrant
Agreement between NeoGenomics, Inc. and Aspen Select Healthcare, L.P.
issued March 30, 2006
|
(iii)
|
10.12
|
Amended
and Restated NeoGenomics Equity Incentive Plan, dated October 31,
2006
|
(vi)
|
10.13
|
NeoGenomics
Employee Stock Purchase Plan, dated October 31, 2006
|
(vi)
|
10.14
|
Agreement
with Power3 Medical Products, Inc regarding the Formation of Joint Venture
& Issuance of Convertible Debenture and Related
Securities
|
Provided
herewith
|
14.1
|
NeoGenomics,
Inc. Code of Ethics for Senior Financial Officers and the Principal
Executive Officer
|
(v)
|
83
31.1
|
Certification
by Principal Executive Officer pursuant to 15 U.S.C. Section 7241, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
Provided
herewith
|
31.2
|
Certification
by Principal Financial Officer pursuant to 15 U.S.C. Section 7241, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
Provided
herewith
|
31.3
|
Certification
by Principal Accounting Officer pursuant to 15 U.S.C. Section 7241,
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
Provided
herewith
|
32.1
|
Certification
by Principal Executive Office, Principal Financial Officer and Principal
Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
Provided
herewith
|
(i)
|
Incorporated
by reference to the Company’s Registration Statement on Form SB-2, filed
February 10, 1999.
|
|
(ii)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB for the year
ended December 31, 2002, filed May 20, 2003.
|
|
(iii)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB for the year
ended December 31, 2005, filed April 3, 2006.
|
|
(iv)
|
Incorporated
by reference to the Company’s Report on Form 8-K, filed March 30,
2005.
|
|
(v)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB for the year
ended December 31, 2004, filed April 15, 2005.
|
|
(vi)
|
Incorporated
by reference to the Company’s Quarterly Report on Form 10-QSB for the
quarter ended September 30, 2006, filed November 17, 2006.
|
ITEM
14. PRINCIPAL
ACCOUNTANT FEES AND SERVICES
Summarized below is the aggregate
amount of various professional fees billed by our principal accountants with
respect to our last two fiscal years:
2006
|
2005
|
|||||||
Audit
fees
|
$ | 32,000 | $ | 28,000 | ||||
Audit-related
fees
|
$ | — | $ | — | ||||
Tax
fees
|
$ | 3,000 | $ | 2,000 | ||||
All
other fees, including tax consultation
and
preparation
|
$ | 9,000 | $ | — |
All audit fees are approved by our
Audit Committee and Board of Directors. Other than income tax preparation
services, Kingery & Crouse, P.A. does not provide any non-audit
services to the Company.
84
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
April 29, 2008 .
NeoGenomics, Inc.
By: _/s/ Robert
P. Gasparini__________
Robert P.
Gasparini
President
and
Principal
Executive Officer
Date: April
29, 2008
By: _/s/ Steven
C. Jones
Steven C.
Jones
Acting
Principal Financial Officer
Date: April
29, 2008
By: _/s/ Jerome
Dvonch__________
Jerome
Dvonch
Principal
Accounting Officer
Date: April
29, 2008
In
accordance with the Exchange Act, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the
dates indicated.
SIGNATURE
TITLE
DATE
/s/ Michael
T.
Dent
Chairman of the
Board April 29,
2008
Michael
T. Dent, M.D.
/s/ Robert P.
Gasparini
President and
Director April 29,
2008
Robert P.
Gasparini
/s/ Steven C.
Jones
Director
April 29, 2008
Steven C.
Jones
/s/ George
O’Leary
Director
April 29, 2008
George
O’Leary
/s/ Peter M.
Petersen
Director
April 29, 2008
Peter
Petersen
85
EXHIBIT
31.1
CERTIFICATION
PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I, Robert
P. Gasparini, Principal Executive Officer, certify that:
1. I
have reviewed this annual report on Form 10-KSB/A of NeoGenomics,
Inc.;
2. Based
on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this annual report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the small business issuer as
of, and for, the periods presented in this report;
4. The
small business issuer’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the small business issuer and
have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision,
to ensure that material information relating to the small business issuer,
including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report
is being prepared;
|
|
(b)
|
Omitted;
|
|
(c)
|
Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation;
and
|
|
(d)
|
Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business issuer’s
most recent fiscal quarter (the small business issuer’s fourth fiscal
quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the small business issuer’s
internal control over financial reporting;
and
|
5. The
small business issuer’s other certifying officer(s) and I have disclosed, based
on my most recent evaluation of internal control over financial reporting, to
the small business issuer’s auditors and the audit committee of the small
business issuer’s board of directors (or persons performing the equivalent
functions):
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer’s ability
to record, process, summarize and report financial information;
and
|
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
|
Date: April 29,
2008
|
By: /s/ Robert P.
Gasparini
|
Name: Robert
P. Gasparini
|
|
Title: President
and Principal Executive Officer
|
|
*The
introductory portion of paragraph 4 of the Section 302 certification that refers
to the certifying officers’ responsibility for establishing and maintaining
internal control over financial reporting for the company, as well as paragraph
4(b), have been omitted in accordance with Release No. 33-8545 (March 2, 2005)
because the compliance period has been extended for small business issuers until
the first fiscal year ending on or after December 15, 2007.
86
EXHIBIT
31.2
CERTIFICATION
PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I, Steven
C. Jones, Principal Financial Officer, certify that:
1. I
have reviewed this annual report on Form 10-KSB/A of NeoGenomics,
Inc.;
2. Based
on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this annual report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the small business issuer as
of, and for, the periods presented in this report;
4. The
small business issuer’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the small business issuer and
have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision,
to ensure that material information relating to the small business issuer,
including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report
is being prepared;
|
|
(b)
|
Omitted;
|
|
(c)
|
Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation;
and
|
|
(d)
|
Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business issuer’s
most recent fiscal quarter (the small business issuer’s fourth fiscal
quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the small business issuer’s
internal control over financial reporting;
and
|
5. The
small business issuer’s other certifying officer(s) and I have disclosed, based
on my most recent evaluation of internal control over financial reporting, to
the small business issuer’s auditors and the audit committee of the small
business issuer’s board of directors (or persons performing the equivalent
functions):
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer’s ability
to record, process, summarize and report financial information;
and
|
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
|
Date: April 29,
2008
|
By: /s/ Steven C.
Jones
|
Name: Steven
C. Jones
|
|
Title: Acting
Principal Financial Officer
|
*The
introductory portion of paragraph 4 of the Section 302 certification that refers
to the certifying officers’ responsibility for establishing and maintaining
internal control over financial reporting for the company, as well as paragraph
4(b), have been omitted in accordance with Release No. 33-8545 (March 2, 2005)
because the compliance period has been extended for small business issuers until
the first fiscal year ending on or after December 15, 2007.
87
EXHIBIT
31.3
CERTIFICATION
PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jerome
J. Dvonch, Principal Accounting Officer, certify that:
1. I
have reviewed this annual report on Form 10-KSB/A of NeoGenomics,
Inc.;
2. Based
on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this annual report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the small business issuer as
of, and for, the periods presented in this report;
4. The
small business issuer’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the small business issuer and
have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision,
to ensure that material information relating to the small business issuer,
including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report
is being prepared;
|
|
(b)
|
Omitted;
|
|
(c)
|
Evaluated
the effectiveness of the small business issuer’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation;
and
|
|
(d)
|
Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business issuer’s
most recent fiscal quarter (the small business issuer’s fourth fiscal
quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the small business issuer’s
internal control over financial reporting;
and
|
5. The
small business issuer’s other certifying officer(s) and I have disclosed, based
on my most recent evaluation of internal control over financial reporting, to
the small business issuer’s auditors and the audit committee of the small
business issuer’s board of directors (or persons performing the equivalent
functions):
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer’s ability
to record, process, summarize and report financial information;
and
|
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer’s
internal control over financial
reporting.
|
Date: April
29, 2008
|
By: /s/ Jerome J.
Dvonch
|
Name: Jerome
J. Dvonch
|
|
Title: Principal
Accounting Officer
|
*The
introductory portion of paragraph 4 of the Section 302 certification that refers
to the certifying officers’ responsibility for establishing and maintaining
internal control over financial reporting for the company, as well as paragraph
4(b), have been omitted in accordance with Release No. 33-8545 (March 2, 2005)
because the compliance period has been extended for small business issuers until
the first fiscal year ending on or after December 15, 2007.
88
EXHIBIT
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of
NeoGenomics, Inc. (the “Company”) on Form 10-KSB/A for the fiscal year ended
December 31, 2006 as filed with the Securities and Exchange Commission on the
date hereof (the “Report”), the undersigned, in the capacities and on the dates
indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his
knowledge:
1. The
Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
2. The
information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company.
|
Date: April
29,
2008 ______/s/ Robert
P. Gasparini_____
|
Robert P.
Gasparini
President
and
Principal Executive
Officer
|
Date: April
29,
2008 ______/s/ Steven
C. Jones__
|
Steven C.
Jones
Acting Principal Financial
Officer
|
Date: April
29,
2008 ______/s/ Jerome
J. Dvonch__
|
Jerome J.
Dvonch
Principal Accounting
Officer
A signed original of this written
statement required by Section 906, or other document authenticating,
acknowledging, or otherwise adopting the signature that appears in typed form
within the electronic version of this written statement required by Section 906,
has been provided to the Company and will be retained by the Company and
furnished to the Securities and Exchange Commission or its staff upon
request.
89