form10ksba.htm
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
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.
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
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
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
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
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
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.
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.
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.
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.
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.
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
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.
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
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.
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
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.
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.
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.
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.
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.
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.
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
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.
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.
Our
critical accounting policies are those where we have made difficult, subjective
or complex judgments in making estimates, and/or where these estimates can
significantly impact our financial results under different assumptions and
conditions. Our critical accounting policies are:
|
·
|
Stock-based
Compensation
|
Revenue
Recognition
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.
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.
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
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.
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,
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.
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
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.
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.
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
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
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.
|
|
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’
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.
|
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
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.
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
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
|
[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
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.
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.
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.
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.
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.
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