SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
x
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ANNUAL
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES AND
EXCHANGE
ACT OF 1934
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For
the fiscal year ended December 31, 2009
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
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For
the transition period
from to
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Commission
File Number: 001-32715
INTERLEUKIN
GENETICS, INC.
(Name of
Registrant in its Charter)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
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94-3123681
(I.R.S.
Employer
Identification
No.)
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|
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135
Beaver Street, Waltham, MA
(Address
of principal executive offices)
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02452
(Zip
Code)
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Registrant’s
Telephone Number:
(781) 398-0700
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Securities
registered pursuant to Section 12(b) of the Exchange
Act:
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|
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Common
Stock, $0.001 par value
per
share
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NYSE
Amex LLC
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Securities
registered pursuant to Section 12(g) of the Exchange
Act:
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Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. YES
o
NO
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act. YES
o
NO
x
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. YES
o
NO
x
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). YES
o
NO
o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained in this form and will not be contained, to
the best of the registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or
any amendment to this Form 10-K
x
.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer, or a smaller reporting company.
See the definitions of “large accelerated filer,” “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer
o
|
Accelerated
filer
o
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Non-accelerated
filer
o
(Do
not check if a smaller reporting company)
|
Smaller
reporting company
x
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). YES
o
NO
x
The
aggregate market value of the registrant’s voting and non-voting common stock
held by non-affiliates of the registrant (without admitting that any person
whose shares are not included in such calculation is an affiliate) computed by
reference to the price at which the common stock was last sold as of the last
business day of the registrant’s most recently completed second quarter was
$16,645,635.
As of
March 18, 2010 there were 36,494,890 shares of the registrant’s Common Stock and
5,000,000 shares of the registrant’s Series A Preferred Stock, issued and
outstanding.
Documents
Incorporated By Reference
Portions
of the registrant’s Definitive Proxy Statement for the 2010 Annual Meeting of
Shareholders to be held on or about June 17, 2010, are incorporated by
reference in Part III hereof.
INTERLEUKIN
GENETICS, INC.
FORM
10-K
FOR
THE YEAR ENDED DECEMBER 31, 2009
Table
of Contents
PART
I
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Item 1.
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Business
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3
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Item 1A.
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Risk
Factors
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13
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Item 2.
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Properties
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22
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Item 3.
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Legal
Proceedings
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22
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PART
II
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Item 4.
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[Reserved]
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22
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Item 5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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23
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Item 6.
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Selected
Consolidated Financial Data
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23
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Item 7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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25
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Item 7A.
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Quantitative
and Qualitative Disclosure about Market Risk
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35
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Item 8.
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Financial
Statements and Supplementary Data
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35
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Item 9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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58
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Item 9A(T).
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Controls
and Procedures
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59
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Item 9B.
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Other
Information
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59
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PART
III
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Item 10.
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Directors,
Executive Officers and Corporate Governance
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60
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Item 11.
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Executive
Compensation
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60
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Item 12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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60
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Item 13.
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Certain
Relationships and Related Transactions, and Director
Independence
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60
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Item 14.
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Principal
Accountant Fees and Services
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60
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PART
IV
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Item 15.
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Exhibits
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61
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PART
I
Special
Note Regarding Forward-Looking Statements
This
Annual Report on Form 10-K and, in particular, the description of our
Business set forth in Item 1, the Risk Factors set forth in Item 1A
and Management’s Discussion and Analysis of Financial Condition and Results of
Operations set forth in Item 7, and the documents incorporated by reference
into this report contain or incorporate certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Statements contained in this report that are not statements of
historical fact may be deemed to be forward-looking statements. Words or phrases
such as “may,” “will,” “could,” “should,” “potential,” “continue,” “expect,”
“intend,” “plan,” “estimate,” “anticipate,” “believe,” “project,” “likely,”
“outlook,” or similar words or expressions or the negatives of such words or
expressions are intended to identify forward-looking statements. We base these
statements on our beliefs as well as assumptions we made using information
currently available to us. Such statements are subject to risks, uncertainties
and assumptions, including those identified in Item 1A “Risk Factors” and
elsewhere in this report, as well as other matters not yet known to us or not
currently considered material by us. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those anticipated, estimated or
projected. Given these risks and uncertainties, prospective investors are
cautioned not to place undue reliance on such forward-looking statements.
Forward-looking statements do not guarantee future performance and should not be
considered as statements of fact. All information set forth in this
Form 10-K is as of the date of filing this Form 10-K and should not be
relied upon as representing our estimate as of any subsequent date. While we may
elect to update these forward-looking statements at some point in the future, we
specifically disclaim any obligation to do so to reflect actual results, changes
in assumptions or changes in other factors affecting such forward-looking
statements.
Item 1.
Business
Overview
Interleukin
Genetics, Inc. is a personalized health company that develops
condition-focused, unique genetic tests. Our overall mission is to provide
genetic test products that can help individuals maintain or improve their health
through preventive measures. Our vision is to use the science of applied
genetics to empower individuals and physicians to better understand the set of
actions and steps necessary to guide lifestyle and treatment options. We believe
that the science of applied genetics can help companies provide improved
services to their customers, empower individuals to personalize their health and
assist in improving outcomes in drug development and use by identifying
subpopulations that are more responsive to the therapy. We currently have two
primary focus areas to our business. The first is personalized health, focused
on providing genetic test products and services via third party partners or
directly to end users. These products are developed with the goal of providing
guidance to individuals interested in improved wellness. The second is research
and development, focused on developing genetic tests linked to a partner’s
products in medical and dental channels. Both contribute toward our overall
mission of providing products that can help individuals maintain or improve
their health through preventive or treatment measures. Our revenue is derived
from;
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·
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selling
our genetic tests to the end users;
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·
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receiving
royalties from partners selling our
products;
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processing
genetic risk assessment tests in our Clinical Laboratory Improvement
Amendments of 1988, or CLIA,-certified lab for
partners;
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conducting
research to develop new genetic risk assessment tests for us and
partners.
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We
believe that by providing important genetic information such as the
identification of variants in one or more genes, combined with a set of actions
and recommendations about possible interventions and guided therapies that may
be used based on those variants, we can help individuals improve their health
outcomes. We have patents covering the influence of certain gene variations for
a number of common chronic diseases and conditions.
We
believe that one of the great challenges confronting healthcare today is to
better understand why some people are more prone than others to develop various
medical conditions and why some people respond to treatments for those
conditions differently than others. Until individuals or their providers are
able to understand the underlying causes of such variability, healthcare will
remain largely constrained by the current approach of broad treatment rather
than customized prevention and treatment. Most recommendations for a given
condition do not consider genetic differences among individuals and, as a
result, individuals whose conditions may be different because of genetic
variation all receive the same treatment.
Until
recently, scientific study of chronic health conditions has largely focused on
identifying initiating factors that are causative and ways to alter or reverse
the cause or condition. Common examples of altering or reversing initiating
factors include calorie reduction in the case of being overweight, reducing
levels of cholesterol in the case of heart disease, elimination of bacteria in
the case of periodontal disease and reducing estrogen levels in the case of
osteoporosis. However, the mere presence of initiating factors does not
necessarily mean a person will develop an illness or that a set of actions will
work well for everyone the same way. Many common conditions arise in part as a
result of how our bodies respond to various environmental factors.
Genetic
Test Products
We
believe that a common misconception today is that genetics dictate how an
individual will look or feel and that there is nothing one can do to change the
destiny set by one's genes. While it is true that genetics have a strong
influence on a person's appearance or condition (referred to as a phenotype), it
is not true that a person is powerless to influence the outcome. An active field
of research in healthcare today is to better understand the interaction between
our environment and our genes. This relationship between genetics and
environmental factors such as lifestyle and diet is referred to as epigenetics.
The scientific community is learning more each day about the role and
significance of genetic variations, such as single nucleotide polymorphisms, or
SNPs, and haplotypes, on an individual’s health. SNP and haplotype analysis
coupled with detailed knowledge of environmental factors now is an important
area of study in order to improve human health. A SNP may cause a gene to make a
different amount of a protein for a given condition, change the timing of
protein synthesis or make a variant form of the protein; each of these changes
may lead to a discernible physiological impact. However, certain lifestyle
changes can influence significantly whether a set of genes are activated or
deactivated despite the variation in the gene. Thus while the propensity for
physiological impact is always present for a given set of genes and their
variants, whether or not the condition manifests itself may be controlled by our
environment and the lifestyle choices we make.
We have
focused our research, development commercialization efforts on the SNP
variations associated with inflammation and metabolic disease for which there is
biological understanding. We have worked with several universities including the
University of Sheffield in the United Kingdom to identify several SNPs and other
factors that influence the body’s inflammatory response. Sir Gordon Duff,
one of the pioneers in the understanding of the role that genetics plays in
inflammatory disease pathways, continues to serve as a member of our scientific
advisory board. In addition, we have conducted clinical studies throughout the
world involving over 22,000 individuals to make these research findings
clinically useful. To date, some of our clinical research collaborations
include, or have included, studies at Stanford University, the University of
North Carolina at Chapel Hill, the Mayo Clinic; Brigham & Women’s
Hospital (Harvard Medical College); University of California at San Francisco;
University of California at San Diego; New York University Medical Center;
University of Sheffield, UK; Yonsei University Medical Center, Seoul Korea;
Tongji Medical College, Wuhan China; and Tuft’s University Medical Center. We
have also conducted research with the Geisinger Clinic.
Metabolism
and Inflammation
Metabolism
is the physical and chemical processes in an organism by which the organism’s
material substances are produced, maintained or destroyed and by which energy is
made available. These processes maintain life and permit organisms to grow and
reproduce as well as respond to their environments. Metabolism consists of two
different categories; catabolism which breaks down organic matter to release
energy and anabolism which uses energy to construct components of cells such as
proteins, nucleic acids, or other components. The speed of metabolic processes
can influence how much food an organism will require to live. Recent scientific
results have shown that there are significant SNP variations in the genes that
control various metabolic pathways and processes.
A
person's weight or their nutritional needs can be governed by the genetics
involved in various metabolic pathways. The onset of a metabolic condition such
as diabetes or obesity has been shown to be linked to lifestyle as well as
genetic factors. Thus one's diet, exercise and nutrition choices have a strong
effect on how the genetics that influence metabolism behave and thereby
influence one’s overall health and well-being.
Inflammation
is one of the body’s most basic protective mechanisms and the understanding of
the role of inflammation in disease and various other conditions has increased
over the past few years. It is generally accepted that many chronic conditions
begin with a challenge to the tissues of the body and that the inflammatory
response system of an individual mediates the clinical manifestation. It is also
now thought that SNP variations in the genes that influence the inflammatory
process can have an important impact on a person’s risk/trajectory of a disease
for the same set of initiating events or conditions.
Typical
inflammatory diseases include rheumatoid arthritis, periodontitis and
osteoarthritis. In recent years, inflammation has been found to affect several
other major diseases of aging. Chronic inflammation can influence the process
that leads to acute heart attacks. For example, an individual that has a strong
inflammatory response may be more successful in clearing a bacterial infection
than an individual with a less robust inflammatory response. However, that
strong inflammatory response may actually cause that individual to be at
increased risk for a more severe course in one or more of the chronic diseases
that generally affect people in mid to later life, such as cardiovascular
disease, osteoporosis, osteoarthritis, asthma, periodontal disease and
Alzheimer’s disease. Individuals’ gene variations influence the severity of the
risks and predispositions to these diseases.
Intellectual
Property
Our
intellectual property is focused on the discoveries that link variations in key
inflammation and metabolic genes to various conditions or illnesses. We
initially had concentrated our efforts on variations in the genes for the
interleukin family of cytokines, because these compounds appear to be one of the
strongest control points for the development and severity of inflammation. Our
patents also cover genetic variations in the Perilipin family of proteins and
others that are involved in fat storage and metabolism.
We have
patents issued on single SNPs and SNP patterns in gene clusters as they relate
to use for identifying individuals on a rapid path to several medical conditions
or for use in guiding the selection of diets, exercise, vitamin needs,
preventive care and also therapeutic agents. Groups of SNPs are often inherited
together as patterns called haplotypes. We have a U.S. patent issued on
haplotypes in an interleukin gene cluster and their biological and clinical
significance. We believe these patents are controlling relative to interleukin
SNPs and haplotype patterns that would be used for genetic risk assessment
tests.
We
currently own rights in fifteen issued U.S. patents, which have expiration dates
between 2015 and 2020, and have twenty-four additional U.S. patent applications
pending, which are based on novel associations between particular gene sequences
and certain inflammatory diseases and disorders. The fifteen issued U.S. patents
relate to genetic tests for periodontal disease, osteoporosis, asthma, coronary
artery disease, sepsis and other diseases associated with interleukin
inflammatory haplotypes. Our newest patent applications relate to the commercial
use of SNP panels in the fields of weight management, periodontal disease,
osteoporosis and osteoarthritis. If granted, we expect many of these patents are
likely to expire until between 2027 and 2030.
Our
intellectual property and proprietary technology are subject to numerous risks,
which we discuss in the section entitled “Risk Factors” of this report. Our
commercial success may depend at least in part on our ability to obtain
appropriate patent protection on our therapeutic and diagnostic products and
methods and our ability to avoid infringing on the intellectual property of
others.
We have
been granted a number of corresponding foreign patents and have a number of
foreign counterparts of our U.S. patents and patent applications
pending.
Our
Approach to Test Development
We seek
to develop products that will benefit individuals seeking preventive or
treatment guidance for their particular conditions or illnesses. In order to do
so, we believe a genetic test must be useful, understandable, credible and
provide actionable guidance. The action resulting from the information we seek
to provide through our genetic tests could be either some form of medical
treatment, dietary alteration, lifestyle change, or more careful monitoring of
the person's condition. We make it a priority to understand the market potential
for our genetic tests before developing them. Finally, we must be able to launch
and sell a given product effectively.
Multiple
genes and complex gene interactions along with environmental factors determine
the risk for the common diseases. We may develop a test based on our proprietary
genetic markers including important SNPS we have identified if: a) clinical
studies show that their effect has a critical and unique influence on the
clinical expression of disease, or b) our genetic markers guide the
development or use of lifestyle, preventive measures or therapeutic agents that
modulate the specific actions of those genetic factors. The risk effects of our
genetic factors must be sufficiently powerful so that these genetic markers
cannot be excluded from a test panel without substantially reducing the
practical clinical usefulness of the test. For example, clinical studies have
shown that in patients with a history of heart disease, higher levels of
inflammation (as measured by certain markers such as C-reactive protein, a
transient marker for inflammation) are predictive of future heart attacks.
Indeed, studies published toward the end of 2008 indicated that chronic
underlying inflammation has been shown to be a critical factor for increased
heart attack risk. We believe that our proprietary genetic variations reliably
identify those individuals who have a lifelong tendency to experience elevated
inflammation and therefore to have higher risk for heart disease. Development
efforts will to continue to use our proprietary genetic technology as part of a
broader genetic panel that predicts an individual’s risk for disease as they age
or predicts a patient’s likelihood of severe complications from disease or
response to specific treatment if they have already been diagnosed with
disease.
For each
targeted clinical disease area that meets our criteria, we may develop
proprietary tests that are anchored by our intellectual property, plus
additional candidate genes that have been validated and shown to be of value.
Other genes that are added to a test panel may be in-licensed or may be
available from the public domain. For example, the osteoporosis risk assessment
panel we launched in December 2009 includes multiple SNPs covered by our
intellectual property, plus additional genes that have been validated as risk
factors for osteoporosis. Since knowledge about the genes involved in human
health will continue to evolve over many years, we may introduce test panels
that initially have our proprietary genetic factors with successive versions of
additional genes.
We also
believe that combining, in non-obvious ways, single gene variations to create a
unique or novel tool may result in new, proprietary intellectual property for
us. For example, the weight management genetic test panel we introduced in June
2009 involves five SNPs in four genes. Patent applications covering this product
have been filed.
In the
past few years, the use of haplotypes has become a standard approach to genetic
risk assessment for complex diseases. Haplotypes are blocks of SNPs that are
inherited together from one parent and in some cases the specific block of SNPs
has functional significance beyond the biological functions attributable to the
individual SNPs. The same SNP may have very different effects on gene function
in different individuals depending on the haplotype context. We believe that we
have expertise, experience and intellectual property related to the use of
haplotypes in assessing genetic risk for complex diseases and we have filed
patents in this area as well.
Business Strategy
We expect
our revenue model to consist of:
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·
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sales
from our Inherent Health
®
brand of genetic tests either directly to end users or through
partnerships such as the Amway Global
channel;
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·
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fees
for processing genetic risk assessment tests of the
Gensona
brand of tests sold in Canada by Amway Global, the North American division
of the Alticor Corporation;
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·
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royalties
or profit sharing from sales of genetic test products developed by us and
marketed by a partner such as LABEC Pharma and Quest Diagnostics’ OralDNA
Labs division;
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·
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fees
for contract research with third parties;
and
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·
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license
fees for our intellectual property and
products.
|
In August
2008, we entered into a nonexclusive license agreement with OralDNA Labs, Inc.,
now a division of Quest Diagnostics to market our PST genetic risk assessment
test for the prediction of periodontal disease. Quest Diagnostics sells the PST
test directly to dentists throughout the United States. We earn a royalty and a
processing fee from each sale of the PST test.
In April
2009, we entered into an exclusive license agreement with LABEC Pharma for Spain
and Portugal to market our heart health genetic risk assessment test for the
prediction of early heart attack in Spain and Portugal. The test will be
marketed under the brand name Cardiohealth
TM
. In
January 2010, European regulatory authorities authorized LABEC Pharma to begin
selling the CardioHealth product.
In June
2009, we launched our own brand of consumer genetic tests under the name
Inherent Health
®
. Our
business strategy is to develop test products for our own business needs under
the Inherent Health
®
brand
and perform R&D services for partners interested in developing genetic tests
to support their products. In addition, we plan to commercialize R&D test
products and services through strategic alliances. We plan to continue to grow
the Inherent Health
®
business
and to continue to launch products in new channels, including through
distribution partners. We are also interested in in-licensing products or
intellectual property to create new products. Our genetic testing business will
continue to explore large potential markets such as weight management,
osteoporosis, and arthritis, where there is a clear unmet medical need for
improved care. We expect that our research and development initiatives will
continue to enhance our intellectual property position, ensure commercial and
technical success of our products, and help partners to develop formulary
solutions that enable our partners to offer prevention and intervention
therapeutics in a consumer and/or medical segment
In
October 2009, we entered into a Merchant Network and Channel Partner Agreement
with Alticor's Amway Global Company to market our Inherent Health
®
genetic
assessment tests. Under this agreement, Amway Global’s independent business
owners, or IBOs, are able to purchase the Inherent Health
®
brand of
genetic tests via a hyperlink from the Amway Global website to the Inherent
Health
®
website.
We believe our proprietary genetic test brands supports the efforts of Amway
Global to develop personalized consumer products for their IBO’s customers.
Sales with Amway global through this new business arrangement began in December
2009.
Our
Products and Product Development Pipeline
Our current business plan includes
focusing our efforts on commercializing our existing genetic test products and
developing additional genetic test products. Our plan is to commercialize and
develop test products that (1) identify healthy individuals who are at increased
risk for early or more severe health risks, (2) allow for an individual to
understand which lifestyles will be best suited for their needs and (3) may be
used in patients who have already been diagnosed with a specific disease to
identify those patients who are more likely to develop severe disease
complications and to guide better treatment.
Inherent
Health
®
Brand of
Genetic Tests
In
September 2008, we were successful in negotiating a new agreement with Alticor
whereby Alticor’s license to our technology became non-exclusive. The agreement
continued to allow Interleukin Genetics to have exclusive ownership of all
inventions relating to genetic tests arising from research programs between the
companies.
In addition,
under the new agreement, we were able to obtain the rights to market all IP,
including the genetic tests, outside of the Alticor channel. As a result, in
2009, we created and launched our own brand of genetic test products under the
Inherent Health
®
brand
name, which consists of the following genetic tests products:
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·
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Our
Weight Management Genetic Test takes the guesswork out of finding an
effective diet and exercise solution by revealing actionable steps to
achieve weight goals based on your genetics. The test determines whether a
low fat, low carbohydrate or balanced diet may be best for you, and
whether you need normal or vigorous exercise to most efficiently lose
existing body fat. The test provides new information beyond traditional
assessments to help you understand the genetic factors that lead to weight
gain, so that you can tailor your nutritional intake and fitness routine
for improved, sustainable results.
|
On March
3, 2010 we and researchers from Stanford University announced findings from a
retrospective clinical study collaboration involving our Weight Management
Genetic Test during a presentation at the American Heart Association’s annual
epidemiology and prevention conference. According to Stanford University
researchers, the differences in weight loss that were observed in individuals
who followed a diet matched to their genotype versus one that was not matched to
their genotype “is highly significant in numerous categories and represents an
approach to weight loss that has not been previously reported in the
literature.”
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·
|
Our
Bone Health Genetic Test will identify whether you are more likely to be
susceptible to spine fractures and low bone mineral density associated
with osteoporosis. Although typically starting later in life, early
intervention can help prevent osteoporosis. Preventative measures can
reduce the risk for bone loss and fractures, which in the case of
vertebral fractures leads to a hunched over
appearance.
|
|
·
|
Our
Heart Health Genetic Test identifies your genetic predisposition to heart
attack based on inflammation. The genetic analysis identifies individuals
that have a lifelong tendency to overproduce certain chemicals in the body
that lead to inflammation. Overproduction of these chemicals can start a
chain reaction that ultimately may lead to a heart attack. Knowing your
genetic risk will enable you to take specific actions to decrease your
overall risk.
|
|
·
|
Our
Nutritional Needs Genetics Test identifies DNA variations in genes crucial
to B-vitamin metabolism and the ability to manage oxidative stress.
Individuals that show suboptimal results for the genes can be at increased
risk for ineffective utilization of B-vitamins and potential for cell
damage caused by oxidative stress, both of which can in some cases lead to
increased risk for certain diseases and
cancers.
|
Medical
Genetic Tests
|
·
|
PST
®
Periodontal Genetic Susceptibility Test – The PST
®
Genetic Test analyzes two Interleukin-1 (IL1) genes for variations that
identify an individual’s predisposition for over-expression of
inflammation and risk for periodontal disease. The test is sold through a
licensing agreement with OralDNA Labs, Inc., a Quest Diagnostics
company.
|
Gensona
Genetic Tests
We had
research agreements with Alticor, which concluded in 2009, to develop certain
genetic tests, which Alticor’s IBOs marketed to consumers through its channel
under their
Gensona
®
brand.
In 2006, we provided two genetic risk assessment tests under these agreements.
In 2009, Amway Global discontinued sale of the
Gensona
®
brand in
the United States. The brand is still selling in Canada and will continue to be
supported. Samples received from test kits previously sold in the United States
and Canada that have not yet been redeemed will continue to be processed. There
were two tests that were developed under the
Gensona
brand name. The first was the
Gensona
Heart Health Genetic Test, which uses SNP testing of two genes to identify
persons who may have an over-expression of inflammation and therefore may be at
increased risk for cardiovascular disease. The second
Gensona
test was the General Nutrition Genetic Test, which identifies SNPs of potential
importance in two genes that affect vitamin B metabolism and four genes involved
in responding to oxidative stress. These two tests have now been rebranded under
the Inherent Health
®
name and
our company is free to partner these products with third parties.
Genetic
Test Product Pipeline
In
addition to the genetic tests listed above that we are currently marketing, we
are also focusing our genetic test development efforts on the following
programs:
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·
|
Obesity
Management Genetic Test — North America populations; Medical
channel
|
|
·
|
Osteoarthritis
Genetic Test — North America populations; Medical
channel
|
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·
|
Periodontal
Disease Genetic Test (version 2.0) — North America and International
populations; Medical and Dental
channel
|
|
·
|
Other
consumer focused genetic tests
|
Obesity
Management Genetic Test
Obesity has become an increasingly
important clinical and public health challenge worldwide. According to the
International Obesity Taskforce estimates, there are about 1.1 billion
overweight and 350 million obese individuals worldwide and these numbers are
expected to grow significantly in the next decade. In the US, prevalence of
obesity has more than doubled in the past 25 years. Nearly two-thirds of adults
are believed to be overweight or obese. Overweight and obese subjects are at a
higher risk of developing one or more serious medical conditions including
hypertension, dyslipidemia, heart diseases and diabetes. In the past few years
public health agencies have been developing strategies and methods to combat
this complex etiology.
Development of obesity is a linear
progression in otherwise healthy individuals with an overweight condition as an
intermediary condition. Overweight/obesity is characterized as an excess of
adipose tissue. The World Health Organization (WHO) and other public health
agencies recommend measurement of three different parameters to determine
overweight/obesity status for an individual, namely, body mass index (BMI),
total body fat and waist/hip ratio (WHR). The cutoff points for each of these
parameters have been well defined.
Human obesity arises from the
interactions of multiple genes, environmental factors and behaviors and renders
management and prevention of obesity very challenging. According to WHO, the
lack of physical activity and easy availability of palatable foods are the
principle modified characteristic of our modern lifestyle that has contributed
to obesity worldwide. Despite the fact that we are all exposed to the same
environment, not everyone is becoming obese. This could be attributed to
individual genetic differences. Genetics determines an individual’s
susceptibility to become obese when exposed to an unfavorable environment as
well as the way a person can respond to diet and exercise. There have been
multiple reports describing the heritability of obesity and also exploring
genetic association studies to identify the gene-gene, gene environment and
gene-diet interactions involved in the development of obesity. These studies
have identified a certain number of SNPs that respond to diet or exercise. For
example, certain SNPs make some people more sensitive to the amount of fat in
the diet, while other SNP’s make some people more resistant to exercise-induced
weight loss.
Under development in weight management
is a genetic test designed to assist with medical and surgical management of
obese individuals. Interleukin Genetics is developing proprietary genetic tests
that have been shown in multiple studies to predict which obese patients were
resistant to weight loss when placed on a medically supervised
calorie-restricted diet.
Osteoarthritis
Genetic Test
Osteoarthritis (OA) is the most common
adult joint disease, increasing in frequency and severity in all aging
populations. The estimated U.S. prevalence is 20-40 million patients or 5
times that of rheumatoid arthritis. The most common forms of OA involve the
hand, knee, hip and spine. Total knee replacements number over 250,000 per year
and total hip replacements number over 300,000 per year in the United States. OA
may involve a single joint or multiple joints in the same individual, with
current therapy focused on pain relief, as there is no FDA-approved therapy that
arrests or reverses the joint deterioration. The etiology of OA is
multifactorial involving both mechanical and biochemical factors. OA progression
is associated with accelerated cartilage degradation leading to joint space
narrowing, painful joint disruption, and functional compromise. The pattern of
manifestation of OA in many ways mimics that of osteoporosis in that it is more
common in women than in men, and it appears to be related to postmenopausal
changes with hormone replacement therapy suppressing cartilage degradation. OA
disease progression is characterized by a proinflammatory gene expression
pattern in cartilage and in joint synovial fluid, with a reactive increase in
bone density in the subchondral bone. Large amounts of data provide support for
a central role of interleukins in the pathogenesis of OA including animal
susceptibility models, models of IL-1-targeted therapy, genetic association
studies, and elevated interleukin gene expression in patients with generalized
OA. Genetic variations in the interleukin gene cluster have been previously
determined to be associated with multiple clinical phenotypes in OA. Our OA
program plans to investigate whether interleukin gene variations together with
several other inflammatory gene variations is associated with the occurrence of
multijoint OA for the development of a genetic risk assessment
test.
Interleukin
Genetics in November 2009 published in the Annals of Rheumatic Diseases new
findings on the genetics of OA. We reported that a panel of genetic markers was
highly predictive of which patients with knee OA were likely to develop severe
disease as they age. The studies were done as a collaboration between
Interleukin and New York University Hospital for Joint Diseases. These findings
were similar in two studies. We believe this information may allow
pharmaceutical companies that are developing the first disease-modifying drugs
for OA (DMOADs) to screen patients and include in their clinical trials only
those patients who have progressive disease. There is currently no mechanism for
selecting high risk patients, and multiple clinical DMOAD studies have failed
due to excessive numbers of patients with no progression of disease. The results
may be useful for setting the dose of hyaluronic acids in the treatment of
osteoarthritis pain. The genetic test could help identify those patients who
need increased frequency dosing regimens or higher doses of the compound. This
genetic information may also assist the rheumatologist in managing the medical
and surgical options of individual patients. Additional studies identified a
different set of genetic markers that were predictive of which patients started
with knee OA and subsequently developed hand problems. We intend to perform
additional studies to clarify the clinical utility of these tests and to search
for marketing and sales partners to introduce the tests into the medical
channel.
Laboratory
Testing Procedure
To
conduct a genetic risk assessment test, the end-user collects cells from inside
the cheek on a brush and submits it by mail to our laboratory. Samples are only
processed with a requisition signed by a physician. Our clinical laboratory then
performs the test following our specific protocol and, depending on the
regulations in the particular state or (in Canada) province, informs the
consumer and the customer’s designated health care provider, of the
results.
During
2004, we completed the construction of our genetic testing laboratory (for which
we obtained registration under CLIA in 2005) to process the test samples. The
regulatory requirements associated with a clinical laboratory are addressed
under the section titled “Government Regulation.” In early 2007, we obtained a
clinical laboratory permit from the State of New York for our Cardiovascular
Genetic test. In 2009 we upgraded the systems and processes for the laboratory
with the addition of high volume analytical equipment. In addition, in 2009 we
received approval to market and distribute our PST test in the state of New
York.
Marketing
and Distribution Strategy
We market
our Inherent Health
®
brand of
genetic tests using our e-commerce website and under contract with Amway. Two of
our genetic tests, the Heart Health Genetic Test and the General Nutrition
Genetic Test, are marketed and distributed in Canada by Amway Global under the
GENSONA
®
brand
through our strategic partnership with Alticor. We also market and distribute
our PST
®
tests
directly to dentists and periodontists via Quest Diagnostic's subsidiary,
OralDNA Labs in the US. In Spain and Portugal, we market our Heart Health test
with LABEC Pharma under the brand name CardioHealth™.
We intend
to develop tests with partners in the pharmaceutical, biotechnology and other
industries. Once tests are developed and launched, reimbursement may come from
various sources including insurance companies, partners or directly from
consumers.
E-commerce
In 2009, we invested in the development
and creation of a complete e-commerce solution for our Inherent Health
®
brand of
genetic tests,
www.inherenthealth.com
. In
addition a completely new test kit package was designed and engineered based on
extensive market research. We have subcontracted with a fulfillment center to
distribute tests to customers ordering via our online store. The e-commerce
solution has provided a friendly and easy to use method for the purchase of our
genetic tests.
Partnerships
with Academic Researchers
We have
(or have had) research collaborations with Stanford University, University of
Sheffield (UK), Tufts University, New York University, Harvard University, the
Mayo Clinic, California Pacific Medical Center, Boston University, the
University of Arkansas, Tongji Medical College (China), University of North
Carolina and Yonsei University (Korea). Through these collaborations, we have
been able to take advantage of research conducted by these third parties in
connection with the development of our genetic risk assessment tests and other
possible products.
Competition
– Genetic Tests
The
competition in the field of personalized health is changing. The markets and
customer base are not well established. There are a number of companies involved
in identifying and commercializing genetic markers. The companies differ in
product end points and target customers. There are companies that market
individual condition genetic tests for complex diseases to consumers and those
that sell only to physicians. There are companies that market testing services
for rare monogenic diseases mainly to physicians. There are companies that sell
genome scanning services to provide customers (usually the consumer directly)
reports on 1,500,000 SNPs to the person’s entire genome. There are
also technology platform companies that sell SNP testing
equipment.
The key competitive
factors affecting the success of any genetic test is its utility, price
(potentially including availability of reimbursement) and the level of market
acceptance.
In the case of newly introduced products requiring “change of
behavior” (such as genetic risk assessment tests), we believe the presence of
multiple competitors may accelerate market acceptance and penetration through
increasing awareness. Moreover, two different genetic risk assessment tests for
the same disease may in fact test or measure different components, and thus,
actually be complementary when given in parallel as an overall assessment of
risk, rather than being competitive with each other. Furthermore, the primary
focus of most companies in the field is performing gene-identification research
for pharmaceutical companies for therapeutic purposes, with genetic risk
assessment testing being a secondary goal. In contrast, our primary business
focus is developing and commercializing genetic risk assessment tests for health
risks and forward-integrating these tests with additional products and
services.
For a
discussion of the risks associated with competition, see “Risks Related to Our
Business, Our Financial Results and Need for Financing - We could become subject
to intense competition from other companies, which may damage our business.”
under "Risk Factors" below in Part I, Item 1A of this
Form 10-K.
Government
Regulation
CLIA
and Other Laboratory Licensure
Laboratories
that perform testing on human specimens for the purpose of providing information
for diagnosis, prevention or treatment of disease or assessment of health are
subject to the Clinical Laboratory Improvement Amendments of 1988, or CLIA. This
law imposes quality standards for laboratory testing to ensure the accuracy,
reliability and timeliness of patient test results. The United States Food and
Drug Administration, or FDA, is responsible for the categorization of
commercially marketed in vitro diagnostic tests under CLIA into one of three
categories based upon the potential risk to public health I reporting erroneous
results. The categories were devised on the basis of the complexity of the test
to include waived tests, tests of moderate complexity and tests of high
complexity. Laboratories performing moderate or high complexity testing must
meet the FDA requirements for proficiency testing, patient test management,
quality control, quality assurance and personnel.
Under
CLIA, certified laboratories are required to hold a certificate applicable to
the type of work they perform and to comply with standards covering personnel,
facilities administration, quality systems and proficiency testing.
CLIA-certified laboratories are typically subject to survey and inspection every
two years to assess compliance with program standards.
In
addition to CLIA certification, laboratories offering clinical testing services
are required to hold certain federal, state and local licenses, certifications
and permits. For example, many CLIA-certified laboratories also seek
accreditation by the College of American Pathologists, or CAP, and licensure by
states that require state-specific licensure for a laboratory that intends to
test clinical samples from residents of that state. The CAP Laboratory
Accreditation Program is an internationally recognized program that utilizes
teams of practicing laboratory professionals as inspectors, and accreditation by
CAP can often be used to meet CLIA and state certification
requirements.
Food
and Drug Administration
Laboratory Developed Tests.
Although the FDA has consistently claimed that it has the regulatory
authority to regulate laboratory-developed tests that are validated by the
developing laboratory and has imposed labeling requirements for the results of
tests utilizing analyte-specific reagents, it has generally exercised
enforcement discretion in not otherwise regulating most tests performed by high
complexity CLIA-certified laboratories. In recent years, the FDA indicated that
it was reviewing the regulatory requirements that will apply to laboratory
developed tests, and in September 2006, the FDA published a draft guidance
document, which it revised in September 2007, or the Draft Guidance, that
describes the FDA’s current position regarding potential regulation of
In Vitro
Diagnostic
Multivariate Index Assays, or IVDMIAs, and the revision provided additional
examples of the types of tests that would be subject to the Draft Guidance. An
IVDMIA is a test system that employs 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.
Although the FDA has not yet issued the
final Guidance, it, the U.S. Congress and the in vitro diagnostic industry
continue to consider the appropriate level of regulation for laboratory
developed tests. In December 2008, Genentech, Inc. submitted a Citizen Petition
to the FDA in which it argued that all in vitro diagnostic tests intended for
use in therapeutic decision making be held to the same scientific and regulatory
standards. Since that time, a number of other companies and organizations have
submitted comments supporting or opposing the citizen Petition. The FDA is
required to rule upon each appropriately filed petition within 180 days of
receipt and may approve it in whole or in part, deny it, or provide a tentative
response indicating why it has been unable to reach a decision on the petition.
To date, the FDA has not taken any public action with respect to the Citizen
Petition, but if it grants the petition, it will likely promulgate regulations
which could increase the amount of FDA regulation to which laboratory developed
tests will by subjected.
In Vitro Diagnostics.
The
type of regulation to which our tests and diagnostics will be subject will
depend in large part on how we intend to commercialize them. Diagnostics that
will be commercialized through direct product sales as in vitro diagnostic kits
will be subject to review by the FDA and must be cleared or approved before they
can be marketed. Tests that are available as clinical laboratory services have
generally not been subject to regulation by the FDA but are subject to other
requirements.
The FDA regulates the sale or
distribution of medical devices, including in vitro diagnostic test kits and
some in vitro diagnostic tests. The information that must be submitted to the
FDA in order to obtain clearance or approval to market a new medical device
varies depending on haw the medical device is classified by the FDA. Medical
devices are classified into one of three classes on the basis of the controls
deemed by the FDA to be necessary to reasonably ensure their safety and
effectiveness. Class I devices are subject to general controls, including
labeling, pre-market notification and adherence to FDA’s quality system
regulation, which are device-specific good manufacturing practices. Class II
devices are subject to general controls and special controls, including
performance standards and post-marketing surveillance. Class III devices are
subject to most of the previously identified requirements as well as to
pre-market approval. Most in vitro diagnostic kits are regulated as Class I or
II devices and are either exempt from premarket notification or require a 510(k)
submission as described below.
510(k) Pre-market
Notification
. A 510(k) notification requires the sponsor to demonstrate
that a medical device is substantially equivalent to another marketed device
that is legally marketed in the United States and for which a pre-market
approval, or PMA, was not required. It does not generally require supporting
clinical data. A device is substantially equivalent to a predicate device if it
has the same intended use and technological characteristics as the predicate; or
has the same intended use but different technological characteristics, where the
information submitted to the FDA does not raise new questions of safety and
effectiveness and demonstrates that the device is at least as safe and effective
as the legally marketed device.
The FDA
may require information regarding clinical data in order to make a decision
regarding the claims of substantial equivalence. If the FDA does not believe
that the device is substantially equivalent to a predicate device, it will issue
a “Not Substantially Equivalent” letter and designate the device as Class III,
which will require approval of a PMA application in order to be
marketed.
Pre-Market Approval.
The PMA
process consists of a scientific and regulatory review to evaluate the safety
and effectiveness of Class III medical devices. The PMA process is considerably
more time consuming and expensive than the 510(k) route, and the application
must be supported by scientific evidence including clinical data, to demonstrate
the safety and efficacy of the medical device for its intended
purpose.
Although
we are not currently offering or developing IVDMIAs or in vitro diagnostic kits,
the FDA’s interest in the degree of appropriate regulation of
laboratory-developed tests could lead to periodic inquiry letters from the FDA
and increased costs and delays in introducing new tests, including genetic
tests. It is possible that a changing regulatory climate could require us to
seek regulatory clearance or approval prior to the launch of genetic risk
assessment tests, which could have a material adverse effect on our
business.
HIPAA
and Other Privacy Laws
The
Health Insurance Portability and Accountability Act of 1996 (HIPAA) established
for the first time comprehensive federal protection for the privacy and security
of health information. The HIPAA standards apply to three types of organizations
(“Covered Entities”): health plans, health care clearing houses, and health care
providers who conduct certain health care transactions electronically. Covered
Entities must have in place administrative, physical and technical standards to
guard against the misuse of individually identifiable health information.
Additionally, some state laws impose privacy protections more stringent than
those of HIPAA. There are also international privacy laws, such as the European
Data Directive, that impose restrictions on the access, use, and disclosure of
health information. Any of these laws may impact our business. We are not
currently a Covered Entity subject to the HIPAA privacy and security standard.
It is possible that in the future we will become a Covered Entity (for example
if any of the tests that we perform become reimbursable by insurers). Regardless
of our own Covered Entity status, HIPAA may apply to our customers.
Our
activities must also comply with other applicable privacy laws. For example,
there are also Canadian and other international privacy laws that impose
restriction of the access, use, and disclosure of health information. All of
these laws may impact our business. Our failure to comply with these privacy
laws could significant impact our business and our future business
plans.
GINA
Legislation
In 2008, the Congress passed and the
President signed into law, the Genetic Information Non-discrimination ACT or
GINA. This law protects individuals from discrimination due to a genetic
predisposition for disease or any other genetic condition. The law protects
individuals who take a genetic test from insurance companies or employers that
may wish to discriminate against a person due to a genetic condition or
predisposition for disease. GINA may also prevent companies from conferring
benefits on persons due to a genetic condition.
FTC
The FTC
regulates the marketing practices and advertising of all our products. In recent
years, the FTC instituted enforcement actions against several dietary supplement
companies for false and misleading marketing practices and advertising of
certain products. These enforcement actions have resulted in consent decrees and
monetary payments by the companies involved. Although the FTC has never
threatened an enforcement action against us for the advertising of our products,
there can be no assurance that the FTC will not question the advertising for our
products in the future.
We
believe that we are currently in compliance with all applicable government
regulations. We cannot predict what new legislation or regulations governing our
operations will be enacted by legislative bodies or promulgated by agencies that
regulate its activities, or what changes in interpretations of existing
regulations may be adopted by the FDA or the FTC.
Other
Information
Our
executive offices are located at 135 Beaver Street, Waltham, Massachusetts
02452, and our telephone number is (781) 398-0700. We were incorporated in
Texas in 1986 and we re-incorporated in Delaware in March 2000. We maintain
websites at
www.ilgenetics.com
and
www.inherenthealth.com. Our Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K, and all amendments to such
reports are available to you free of charge through the Investor Relations
Section of our website as soon as practicable after such materials have been
electronically filed with, or furnished to, the Securities and Exchange
Commission. The information contained on our websites are not incorporated by
reference into this Form 10-K. We have included our website addresses only
as an inactive textual reference and do not intend them to be active links to
our websites.
Item 1A.
Risk Factors
Risks
Related to Our Business, Our Financial Results and Need for
Financing
We
have a history of operating losses and expect these losses to continue in the
future.
We have
experienced significant operating losses since our inception and expect these
losses to continue for some time. We incurred losses from continuing operations
of $5.4 million in 2007, $6.9 million in 2008 and $9.2 million in
2009. As of December 31, 2009, our accumulated deficit was
$91.6 million. Our losses result primarily from research and development,
selling, general and administrative expenses and amortization of intangible
assets. Although we have recently begun to generate revenues from sales of our
genetic risk assessment tests, this may not be sufficient to result in net
income in the foreseeable future. We will need to generate significant revenue
to continue our research and development programs and achieve profitability. We
cannot predict when, if ever, we will achieve profitability.
Our
operating history may make it difficult to evaluate the success of our business
to date and to assess our future viability.
Our
operations to date have been largely limited to research and development of our
technologies and products related to the filed of personalized health. We have
not yet demonstrated an ability to successfully commercialize our genetic tests
or products. Consequently, any predictions about our future success or viability
may not be as accurate as they could be if we had a longer operating history. In
addition, we completed the acquisition of the business of the Alan James Group
in 2006, and sold substantially all of its assets before the opening of business
on July 1, 2009, which makes it difficult to analyze our pre and post
transaction results of operations and to compare them from period to period.
Period-to-period comparisons of our results of operations may not be meaningful
due to these transactions and possible future transactions and are not
indications of our future performance. Any future transactions may make our
results difficult to compare from period to period in the
future.
If
we fail to obtain additional capital, or obtain it on unfavorable terms, then we
may have to end our research and development programs and other
operations.
We expect
that our current and anticipated financial resources, including the amount
available under our credit facility with Pyxis and the $4.9 million in net
proceeds we received from our March 2010 registered direct offering, are
adequate to maintain our current and planned operations for at least the next 18
months. We expect that we may need significant additional capital in the future
to fund our research and product development programs and operations. Our future
capital needs depend on many factors. We may need capital for the commercial
launch of additional genetic tests, continued research and development efforts,
obtaining and protecting patents and administrative expenses. Based on current
economic conditions additional financing may not be available when needed, or,
if available, it may not be available on favorable terms. In addition, the terms
of any financing may adversely affect the holdings or the rights of our existing
shareholders. For example, if we raise additional funds by issuing equity
securities, further dilution to our then-existing shareholders may result. Debt
financing, if available, may involve restrictive covenants that could limit our
flexibility in conducting future business activities. We also could be required
to seek funds through arrangements with collaborators or others that may require
us to relinquish rights to some of our technologies, tests or products in
development. If we cannot obtain additional funding on acceptable terms when
needed, we may have to discontinue operations, or, at a minimum, curtail one or
more of our research and development programs.
The
current economic conditions and financial market turmoil could
adversely affect our business and results of operations.
As widely
reported, economic conditions and financial markets have been experiencing
extreme disruption including, among other things, extreme volatility in prices
of publicly traded securities, severely diminished liquidity, severely
restricted credit availability, rating downgrades of certain investments and
declining valuations of others. Governments have taken unprecedented actions
intended to address these extreme market conditions. Many economists have
predicted that the United States economy, and possibly the global economy, has
entered into a prolonged recession. We believe the current economic
conditions and financial market turmoil could adversely affect our
operations. Uncertainty about current and future economic conditions may
cause consumers to reign in their spending generally, the impact of which may be
that they stop or delay their purchases of our genetic tests and consumer
products. If these circumstances persist or continue to worsen, our future
operating results could be adversely affected, particularly relative to our
current expectations.
We
could become subject to intense competition from other companies, which may
damage our business.
The field
of personalized health is highly competitive. Our potential competitors in the
United States and abroad are numerous and include, among others, major
pharmaceutical and diagnostic companies, consumer products companies,
specialized biotechnology firms, universities and other research institutions.
Many of our competitors have considerably greater financial, technical,
marketing and other resources. Furthermore, many of these competitors are more
experienced than we are in discovering, commercializing and marketing products.
These greater resources may allow our competitors to discover important genes or
genetic markers before we do. If we do not discover genes that are linked to a
health risk, characterize their functions, develop genetic tests and related
information services based on such discoveries, obtain regulatory and other
approvals and launch these services, or products before our competitors, then
our ability to generate sales and revenue will be reduced or eliminated, and
could make our products obsolete. We expect competition to intensify in our
industry as technical advances are made and become more widely
known.
The
market for personalized health generally and genetic risk assessment tests in
particular is unproven.
The
markets and customer base in the field of personalized health are not well
established. Adoption of technologies in this emerging field requires
substantial market development and there can be no assurance that channels for
marketing our products can or will be successfully developed by us or others. As
a result, there can be no assurance that our products will be successfully
commercialized or that they can be sold at sufficient volumes to make them
profitable. If our potential customers do not accept our products, or take a
longer time to accept them than we anticipate, it will reduce our anticipated
sales, resulting in additional losses.
The
market for genetic risk assessment tests, as part of the field of personalized
health, is at an early stage of development and may not continue to grow. The
scientific community, including us, has only a limited understanding of the role
of genes in predicting disease. The success of our genetic risk assessment tests
will depend upon their acceptance as being useful and cost-effective to the
individuals who purchase these products, the physicians and other members of the
medical community who recommend or prescribe them, as well as third-party
payers, such as insurance companies and the government. We can only achieve
broad market acceptance with substantial education about the benefits and
limitations of genetic risk assessment tests while providing the tests at a fair
cost. Furthermore, while positive media attention resulting from new scientific
studies or announcements can spur rapid growth in individual segments of the
market, and also impact individual brands, news that challenges individual
segments or products can have a negative impact on the industry overall as well
as on sales of the challenged segments or products. The marketplace may never
accept our products, and we may never be able to sell our products at a
profit.
Ethical,
legal and social issues related to genetic testing may reduce demand for our
products.
Genetic
testing has raised concerns regarding the appropriate utilization and the
confidentiality of information provided by genetic testing. Genetic tests for
assessing a person’s likelihood of developing a chronic disease have focused
public attention on the need to protect the privacy of genetic information. For
example, concerns have been expressed that insurance carriers and employers may
use these tests to discriminate on the basis of genetic information, resulting
in barriers to the acceptance of genetic tests by consumers. This could lead to
governmental authorities prohibiting genetic testing or calling for limits on or
regulating the use of genetic testing, particularly for diseases for which there
is no known cure. Any of these scenarios could decrease demand for our
products.
Technological
changes may cause our tests to become obsolete.
We have
to date focused our efforts on genetic tests based on a small number of
candidate genes. It is now possible to use array technology to conduct whole
genome association studies for risk assessment, which may make our technologies
obsolete. To date, our tests have been developed on behalf of, and marketed to,
our primary customer, Alticor. In order to develop new customers and markets for
our genetic risk assessment tests, we will be required to invest substantial
additional capital and other resources into further developing these
tests.
We
have limited experience and capabilities with respect to distributing, marketing
and selling genetic risk assessment tests on our own.
We have
historically relied upon Alticor, which is also our largest stockholder, for
sale and distribution of our genetic risk assessment tests, and we have very
limited experience and capabilities with respect to distributing, marketing and
selling genetic risk assessment tests on our own. In June 2009, we announced the
launch of our new Inherent Health
®
brand of
genetic tests. On October 26, 2009, we entered into an agreement with Amway
Global, pursuant to which it will sell the company’s Inherent Health
®
brand of
genetics tests through its e-commerce Web site via a hyperlink to our e-commerce
site. In addition, we have started to market and sell our genetic tests through
other health care and professional channels, and we may attempt to negotiate
marketing and distribution agreements with third parties, although there can be
no assurances we will be able to do so. We have, to date, had very limited
success in marketing and selling our genetic tests, and we can provide no
assurance that our current or planned commercialization efforts will be
successful.
If
we are unsuccessful in establishing additional strategic alliances, our ability
to develop and market products and services may be damaged.
Entering
into additional strategic alliances for the development and commercialization of
products and services based on our discoveries is an important element of our
business strategy. We face significant competition in seeking appropriate
collaborators. If we fail to maintain our existing alliances or to establish
additional strategic alliances or other alternative arrangements, then our
ability to develop and market products and services will be damaged. In
addition, the terms of any future strategic alliances may be unfavorable to us
or these strategic alliances may be unsuccessful.
If
we deliver products with defects, our credibility may be harmed, market
acceptance of our products may decrease and we may be exposed to liability in
excess of our product liability insurance coverage.
The
manufacturing and marketing of professional diagnostic involve an inherent risk
of product liability claims and associated negative publicity. Any defects could
harm our credibility and decrease market acceptance of our products. We
currently maintain product liability insurance, but it is often difficult to
obtain, is expensive and may not be available in the future on economically
acceptable terms. In addition, potential product liability claims may exceed the
amount of our insurance coverage or may be excluded from coverage under the
terms of our policy. We may become subject to product liability claims that,
even if they are without merit, could result in significant legal defense costs
to us. If we are held liable for claims for which we are not indemnified or for
damages exceeding the limits of our insurance coverage, those claims could
materially damage our business and our financial condition. Any product
liability claim against us or resulting recall of our products could create
significant negative publicity.
Our
dependence on key executives and scientists could adversely impact the
development and management of our business.
Our
success depends on the ability, experience and performance of our senior
management and other key personnel. If we lose one or more of the members of our
senior management or other key employees, it could damage our development
programs and our business. In addition, our success depends on our ability to
continue to hire, train, retain and motivate skilled managerial and scientific
personnel. The pool of personnel with the skill that we require is limited.
Competition to hire from this limited pool is intense. We compete with numerous
pharmaceutical and healthcare companies, as well as universities and non-profit
research organizations in the highly competitive Boston, Massachusetts business
area. Our current senior management team is employed by us under agreements that
may be terminated by them for any reason upon adequate notice. There can be no
assurances, therefore, that we will be able to retain our senior executives or
replace them, if necessary. We do not maintain key man life insurance on any of
our personnel.
If
Alticor enters a business in competition with ours, certain of our directors
might have a conflict of interest.
In
conjunction with our strategic alliance with Alticor, we have agreed to certain
terms for allocating opportunities as permitted under Section 122(17) of
the Delaware General Corporation Law. This agreement, regulates and defines the
conduct of certain of our affairs as they may involve Alticor as our majority
stockholder and its affiliates, and our powers, rights, duties and liabilities
and those of our officers and directors in connection with corporate
opportunities. Except under certain circumstances, Alticor and its affiliates
have the right to engage in the same or similar activities or lines of business
or have an interest in the same classes or categories of corporate opportunities
as we do. If Alticor or one of our directors appointed by Alticor and its
affiliates acquire knowledge of a potential transaction or matter that may be a
corporate opportunity for both Alticor, its affiliates and us, to the fullest
extent permitted by law, Alticor and its affiliates will not have a duty to
inform us about the corporate opportunity. In addition, Alticor will not be
liable to us or to you for breach of any fiduciary duty as a stockholder of ours
for not informing us of the corporate opportunity, keeping it for its own
account, or referring it to another person.
Additionally,
except under limited circumstances, if an officer or employee of Alticor who is
also one of our directors is offered a corporate opportunity, such opportunity
shall not belong to us. In addition, we agreed that such director will have
satisfied his duties to us and not be liable to us or to you in connection with
such opportunity. The terms of this agreement will terminate on the date that no
person who is a director, officer or employee of ours is also a director,
officer, or employee of Alticor or its affiliates.
We
may be prohibited from fully using our net operating loss carryforwards, which
could affect our financial performance.
As a
result of the losses incurred since inception, we have not recorded a federal
income tax provision and have recorded a valuation allowance against all future
tax benefits. As of December 31, 2009, we had gross net operating loss and
research tax credit carryforwards of approximately $73.2 million and
$1.3 million, respectively, for federal income tax purposes, expiring in
varying amounts through the year 2029. As of December 31, 2009, we had a
research tax credit carryforward of approximately $0.7 million for state income
tax purposes, expiring in varying amounts through the year 2024. Our ability to
use these net operating loss and credit carryforwards is subject to restrictions
contained in the Internal Revenue Code which provide for limitations on our
utilization of our net operating loss and credit carryforwards following a
greater than 50% ownership change during the prescribed testing period. We have
experienced two such ownership changes. One change arose in March 2003 and the
other was in June 1999. As a result, our net operating loss carryforwards that
relate to periods prior to March 2003 and June 1999 are limited in utilization.
The annual limitation may result in the expiration of the carryforwards prior to
utilization. In addition, in order to realize the future tax benefits of our net
operating loss and tax credit carryforwards, we must generate taxable income, of
which there is no assurance.
Risks
Related to Our Intellectual Property
If
we fail to obtain patent protection for our products and preserve our trade
secrets, then competitors may develop competing products and services, which
will likely decrease our sales and market share.
Our
success will depend on our ability to obtain patent protection in the United
States and in other countries for our products and services. In addition, our
success will also depend upon our ability to preserve our trade secrets and to
operate without infringing upon the proprietary rights of third parties. We own
rights to fifteen issued U.S. patents and have a number of additional U.S.
patent applications pending. We have also been granted a number of corresponding
foreign patents and have a number of foreign counterparts of our U.S. patents
and patent applications pending. Our patent positions, and those of other
pharmaceutical and biotechnology companies, are generally uncertain and involve
complex legal, scientific and factual questions. Our ability to develop and
commercialize products and services depends on our ability to:
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obtain
licenses to the proprietary rights of
others;
|
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·
|
prevent
others from infringing on our proprietary rights;
and
|
Our
pending patent applications may not result in issued patents and any issued
patents may never afford meaningful protection for our technology or products or
provide us with a competitive advantage. If the patents are not issued to us, we
can only rely on common law trademark rights to protect these trademarks and our
trade dress. Common law trademark rights do not provide the same level of
protection as afforded by a United States federal registration of a trademark.
Also, common law trademark rights are limited to the geographic area in which
the trademark is actually used. Further, others may develop competing products,
which avoid legally infringing upon, or conflicting with, our patents. There is
no assurance that another company will not replicate one or more of our
products, and this may harm our ability to do business. In addition, competitors
may challenge any patents issued to us, and these patents may subsequently be
narrowed, invalidated or circumvented.
We also
rely on trade secrets and proprietary know-how that we seek to protect, in part,
with confidentiality agreements. The third parties we contract with may breach
these agreements, and we may not have adequate remedies for any breach. If they
do not protect our rights, third parties could use our technology, and our
ability to compete in the market would be reduced. We also realize that our
trade secrets may become known through other means not currently foreseen by us.
Our competitors may discover or independently develop our trade
secrets.
Third
parties may own or control patents or patent applications and require us to seek
licenses, which could increase our costs or prevent us from developing or
marketing our products or services.
We may
not have rights under patents or patent applications that are related to our
current or proposed products. Third parties may own or control these patents and
patent applications in the United States and abroad. Therefore, in some cases,
to develop or sell any proposed products or services with patent rights
controlled by third parties, our collaborators or ourselves may seek, or may be
required to seek, licenses under third-party patents and patent applications. If
this occurs, we may have to pay license fees, royalties or both, to the
licensor. If licenses are not available to us on acceptable terms, our
collaborators or we may be prohibited from developing or selling our products or
services.
If third
parties believe our products or services infringe upon their patents, they could
bring legal proceedings against us seeking damages or seeking to enjoin us from
testing, manufacturing or marketing our products or services. For example, we
have been named as one of nine defendants in a complaint filed on February 11,
2010 by Genetic Technologies Limited, or GTL, in the United States District
Court for the Western District of Wisconsin and we were served with the
complaint on March 24, 2010. The complaint alleges that each of the defendants
make, use or sell products or services that infringe one or more claims of a
patent owned by GTL, which expires on March 10, 2010. In our case, the complaint
alleges that we offer and provide genetic risk assessment testing services that
utilize methods set forth in one or more claims of the patent. While we believe
that we have substantial defenses to the claims asserted in the complaint, this
litigation or any other litigation, even if without merit, could result in
substantial expenses to us and significant diversion of attention by our
technical and management personnel. Even if we prevail, the time, cost and
diversion of resources of patent litigation would likely damage our business. If
the other parties in any patent litigation brought against us are successful, in
addition to any liability for damages, we may have to cease the infringing
activity or obtain a costly license.
Risks
Related Development, Clinical Testing and Regulatory Approval of Our
Tests
We
are subject to government regulation which may significantly increase our costs
and delay introduction of our products.
We are
subject to a variety of regulatory laws enforced by both the federal government
and the states in which they, and we conduct, or will conduct, business,
including the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and
state clinical laboratory licensure laws and regulations, and the Federal Food,
Drug, and Cosmetic Act and related regulations.
The
growth of our business may increase the potential of violating these laws. The
risk of us being found in violation of these laws and regulations is further
increased by the fact that many of these laws and regulations have not been
fully interpreted by the regulatory authorities or the courts, and their
provisions are open to a variety of interpretations. Any action brought against
us, or any business partners, for violation of these laws or regulations, even
if we or they successfully defend against it, could cause us to incur
significant legal expenses and divert our management’s attention from the
operation of our business. If their or our operations are found to be in
violation of any of these laws and regulations, they or we may be subject to any
applicable penalty associated with the violation, including civil and criminal
penalties, damages and fines, and they or we could be required to curtail or
cease operations. Any of the foregoing consequences could seriously harm our
business and our financial results.
If
we do not comply with governmental regulations applicable to our CLIA-certified
laboratory, we may not be able to continue our operations.
The
establishment and operation of our laboratory, as well as our ongoing research
and development activities occurring in this laboratory, are subject to
regulation by numerous federal, state and local governmental authorities in the
United States. The laboratory holds a CLIA certificate of compliance and is
licensed by the Commonwealth of Massachusetts, and other states as required,
which enables us to provide testing services to residents of most other
states.
Failure
to maintain state regulatory compliance, or changes in state regulatory schemes,
could result in a substantial curtailment or even prohibition of the operations
of our laboratory and could have a material adverse effect on our business. CLIA
is a federal law that regulates clinical laboratories that perform testing on
specimens derived from humans for the purpose of providing information for the
diagnosis, prevention or treatment of disease. To renew CLIA certification,
laboratories are subject to survey and inspection every two years. Moreover,
CLIA inspectors may make random inspections of these laboratories. If we were to
lose our CLIA certification or our state licenses, whether as a result of a
revocation, suspension or limitation, we would no longer be able to continue our
testing operations which would have a material adverse effect on our
business.
Any
tests that may be developed by us may be subject to regulatory approval, which
can be lengthy, costly and burdensome.
Clinical
laboratory tests that are developed and validated by a CLIA–certified laboratory
for its own use are known as laboratory developed tests, or LDTs. Our
currently marketed tests were launched as LDTs our CLIA–certified clinical
laboratory operating in Waltham, Massachusetts. We expect that our future LDTs
will be launched as well at our CLIA-certified laboratory. While
in vitro
diagnostic tests and
test kits that are sold and distributed through interstate commerce are subject
to clearance or approval by the U.S. Food and Drug Administration, or FDA, most
LDTs currently are not subject to this type of FDA regulation. While we
believe that our currently marketed tests and our future LDTs should not be
subject to regulation under current FDA policies, these policies may change
which may result in these tests becoming subject to more extensive FDA
regulation.
Although
our currently marketed tests were, and future clinical laboratory tests are
being developed as LDTs regulated under CLIA and state laboratory laws, these
tests may fall under more extensive FDA regulation in the future. In September
2006, the FDA issued draft guidance on a new class of tests called “In Vitro
Diagnostic Multivariate Index Assays,” or IVDMIAs. Under this draft guidance,
some LDTs, that we may be developing may be determined to be IVDMIAs and could
be classified as Class II or Class III medical devices, which would require FDA
pre-market review or approval depending upon the intended use and on the level
of control necessary to assure the safety and effectiveness of the test. In
July 2007, the FDA posted revised draft guidance on IVMDIAs that includes an
18-month transition. The comment period for this revised guidance expired in
October 2007, and it is not clear whether or when FDA will finalize this draft
guidance.
We cannot
provide any assurance that FDA regulation, including pre-market review or
approval, will not be required in the future for LDTs. If pre-market review or
approval is required, our business could be negatively impacted because our
CLIA-certified laboratory may be required to stop offering these LDTs pending
pre-market clearance or approval.
Tests
based on our technology may require clinical trial testing, which can be
lengthy, costly and burdensome.
If the
FDA decides to require pre-market clearance or approval of tests based
technology, it may require us to perform clinical trials prior to submitting a
regulatory marketing application. If we are required to conduct pre-market
clinical trials, whether using prospectively acquired samples or archival
samples, delays in the commencement or completion of clinical testing could
significantly increase development costs and delay commercialization. The
commencement of clinical trials may be delayed due to insufficient patient
enrollment, which is a function of many factors, including the size of the
patient population and the nature of the disease or condition being
studied.
Our
collaborators may be unable to obtain regulatory approval of any therapeutic
product that they may develop.
Any
therapeutic product that our collaborators may develop will be subject to
extensive governmental regulations relating to development, clinical trials,
manufacturing and commercialization. Rigorous preclinical testing and clinical
trials and an extensive regulatory review process are required to be
successfully completed in the United States and in many foreign jurisdictions
before a new therapeutic product can be sold. Satisfaction of these and other
regulatory requirements is costly, time consuming, uncertain and subject to
unanticipated delays. The time required to obtain FDA and other approvals for
therapeutic products is unpredictable but typically exceeds several years. It is
possible that none of the therapeutic products our collaborators may develop
will obtain the appropriate regulatory approvals necessary for us or our
collaborators to begin selling them.
Furthermore,
any regulatory approval to market a therapeutic product may be subject to
limitations on the indicated uses. These limitations may limit the size of the
market for the therapeutic product. Any therapeutic product that our
collaborators may develop will also be subject to numerous foreign regulatory
requirements governing the conduct of clinical trials, manufacturing and
marketing authorization, pricing and third-party reimbursement. The foreign
regulatory approval process includes all of the risks associated with FDA
approval described above as well as risks attributable to the satisfaction of
local regulations in foreign jurisdictions. Therefore, approval by the FDA of a
therapeutic product does not assure approval by regulatory authorities outside
the United States or vice versa.
If
we fail to comply with regulatory requirements, we could be subject to
enforcement actions, which could affect our ability to market and sell our tests
and may harm our reputation.
If we in
the future fail to comply with applicable federal, state or foreign laws or
regulations, we could be subject to enforcement actions, which could affect the
ability to successfully develop, market and sell our tests and could harm our
reputation and lead to reduced acceptance of such tests or products by the
market. These enforcement actions include:
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recalls,
public notification or medical product safety
alerts;
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restrictions
on, or prohibitions against, marketing such tests or
products;
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restrictions
on importation of such tests or
products;
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suspension
of review or refusal to approve new or pending
applications;
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·
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withdrawal
of product approvals;
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·
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civil
and criminal penalties and fines.
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If
we do not comply with laws regulating the protection of the environment and
health and human safety, our business could be adversely affected.
Our
research and development activities involve the use of hazardous and chemicals
materials, and we maintain quantities of various flammable and toxic chemicals
in our facilities. We believe our procedures for storing, handling and disposing
these materials in our facilities comply with the relevant local and Federal
guidelines. Although we believe that our safety procedures for handling and
disposing of these materials comply with the standards mandated by applicable
regulations, the risk of accidental contamination or injury from these materials
cannot be eliminated. If an accident occurs, we could be held liable for
resulting damages, which could be substantial. We are also subject to numerous
environmental, health and workplace safety laws and regulations, including those
governing laboratory procedures, exposure to blood-borne pathogens and the
handling of biohazardous materials. We may incur substantial costs to comply
with, and substantial fines or penalties if we violate, any of these laws or
regulations.
Risks
Related to Our Common Stock
We
may be delisted from the NYSE Amex resulting in a more limited market for our
common stock
.
In
December 2008, we were notified of our failure to comply with the continued
listing standards of the NYSE Amex, referred to herein as the Exchange, under
section 1003(a)(iii) of the Exchange’s Company Guide because our stockholders’
equity was less than $6,000,000 and we have had losses from continuing
operations and net losses in our five most recent fiscal years. As of December
31, 2008 and 2009 our stockholders’ equity was $4.5 million and ($5.8) million,
respectively. On January 27, 2009, we submitted to the Exchange a plan to regain
compliance with its continued listing requirements. This plan consists of
several elements, but is primarily focused on increasing the sales of our
products and services and raising additional equity capital. On March 27, 2009,
after a review of the compliance plan initially submitted by us, the Corporate
Compliance Staff of the Exchange determined that the compliance plan did not
make a reasonable demonstration of our ability to regain compliance with the
continued listing standards within the compliance period. We appealed the
determination.
On May
11, 2009, upon further review by the Exchange, we were notified that the plan to
meet the Exchange’s continued listing standards was accepted and the Exchange
granted us an extension through December 31, 2009 to become compliant. As a
result of the Staff’s extension, we were not required to attend a hearing before
the Listing Qualifications Panel. In December 2009 we submitted additional
information to the Exchange and have requested another extension. The Exchange
continued to review our progress and on March 17, 2010 granted us an extension
through June 23, 2010 to regain compliance. Failure to make significant progress
consistent with the plan or to regain compliance with the continued listing
standards could result in delisting from the Exchange. If the NYSE Amex delists
our common stock, we anticipate that our common stock would be quoted on the OTC
Bulletin Board or possibly the so-called “pink sheets.” Even if our common stock
is quoted on such systems, a delisting by the NYSE Amex could hurt our investors
by reducing the liquidity and market price of our common stock. Additionally, a
delisting could negatively affect us by reducing the number of investors willing
to hold or acquire our common stock, which could negatively affect our ability
to raise capital.
Our
stock price has been and is likely to continue to be volatile and the market
price of our common stock may drop.
In the two years ended
December 31, 2009, our stock price has fluctuated from a low of $0.13 to a
high of $3.00. Furthermore, the stock market has recently experienced
significant volatility. The volatility of stocks for companies in our industry
often does not relate to the operating performance of the companies represented
by the stock. Some of the factors that may cause the market price of our common
stock to fluctuate include:
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demand
for and acceptance of our products;
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our
ability to develop new relationships and maintain and enhance existing
relationships with strategic
partners;
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regulatory
developments or enforcement in the United States and foreign
countries;
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·
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developments
or disputes concerning patents or other proprietary
rights;
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·
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introduction
of technological innovations or new products or services by us or our
competitors;
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·
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failure
to secure adequate capital to fund our operations, or the issuance of
equity securities at prices below fair market
price;
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changes
in estimates or recommendations by securities analysts, if any cover our
common stock;
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future
sales of our common stock;
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general
market conditions;
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economic
and other external factors or other disasters or
crises;
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period-to-period
fluctuations in our financial results;
and
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overall
fluctuations in U.S. equity
markets.
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These and
other external factors may cause the market price and demand for our common
stock to fluctuate substantially, which may limit or prevent investors from
readily selling their shares of common stock and may otherwise negatively affect
the liquidity of our common stock. In addition, in the past, when the market
price of a stock has been volatile, holders of that stock have instituted
securities class action litigation against the company that issued the stock. If
any of our stockholders brought a lawsuit against us, we could incur substantial
costs defending the lawsuit. Such a lawsuit could also divert the time and
attention of our management.
Our
Series A Preferred Stock has certain rights that are senior to common
stockholder rights and this may reduce the value of our common
stock.
Our
Series A Preferred Stock, which was issued to Alticor in March 2003,
accrues dividends at the rate of 8% of the original purchase price per year,
payable only when and if declared by the Board of Directors and are
non-cumulative. If we declare a distribution, with certain exceptions, payable
in securities of other persons, evidences of indebtedness issued by us or other
persons, assets (excluding cash dividends) or options or rights to purchase any
such securities or evidences of indebtedness, then, in each such case the
holders of the Series A Preferred Stock shall be entitled to a
proportionate share of any such distribution as though the holders of the
Series A Preferred Stock were the holders of the number of shares of our
common stock into which their respective shares of Series A Preferred Stock
are convertible as of the record date fixed for the determination of the holders
of our common stock entitled to receive such distribution. As of
December 31, 2009, our Series A Preferred Stock was convertible into
28,160,200 shares of our common stock, which is subject to standard antidilution
protections as well as adjustments in the event we issue any shares of capital
stock for a price lower than the conversion price of the Series A Preferred
Stock.
In the
event of any liquidation, dissolution or winding up of our company, whether
voluntary or involuntary, the holders of Series A Preferred Stock shall be
entitled to receive, prior and in preference to any distribution of any of our
assets or surplus funds to the holders of our common stock by reason of their
ownership thereof, the amount of two times the then-effective purchase price per
share, as adjusted for any stock dividends, combinations or splits with respect
to such shares, plus all declared but unpaid dividends on such share for each
share of Series A Preferred Stock then held by them. After receiving this
amount, the holders of Series A Preferred Stock shall participate on an
as-converted basis with the holders of common stock in any of our remaining
assets.
Because
a single stockholder has a controlling percentage of our voting power, other
stockholders’ voting power is limited.
As of
December 31, 2009, Alticor was our largest stockholder and owned, or had
rights to acquire, approximately 59% of our outstanding common stock.
Accordingly, this stockholder may be able to determine the outcome of
stockholder votes, including votes concerning the election of directors, the
adoption or amendment of provisions in our Certificate of Incorporation or
By-Laws and the approval of certain mergers and other significant corporate
transactions, including a sale of substantially all of our assets. This
stockholder may make decisions that are adverse to other stockholders’
interests. This ownership concentration may also adversely affect the market
price of our common stock. Four of our seven directors are individuals chosen by
this single stockholder and this stockholder has the right to choose an
additional director. These directors might pursue policies in the interest of
this single stockholder to the detriment of our other stockholders.
We
do not expect to pay dividends for the foreseeable future and you should not
expect to receive any funds without selling your shares of common stock, which
you may only be able to do at a loss.
We have
never declared or paid any cash dividends on our capital stock. Furthermore, our
credit facility with Pyxis prohibits us from paying cash dividends without
Pyxis’s consent. We currently intend to retain any earnings for use in the
operation and expansion of our business and do not anticipate paying any cash
dividends on our common stock in the foreseeable future. Therefore, you should
not expect to receive any funds without selling your shares, which you may only
be able to do at a loss.
Item 2.
Properties
Our
office and laboratory are located at 135 Beaver Street, Waltham, Massachusetts
02452. In February 2004, we entered into a new lease expanding our space to
approximately 19,000 square feet and extended the term of the lease through
March 2009. In November 2008 we entered into an amendment to our current lease
extending the term through March 2014. As part of our sale of substantially all
of the assets of the Alan James Group in July 2009, we relinquished a lease for
4,156 square feet of office space in Boca Raton, Florida. As of December 31,
2009, Waltham, Massachusetts is our only corporate location.
Item 3.
Legal
Proceedings
On
February 11, 2010, Genetic Technologies Limited, or GTL, filed a complaint in
the United States District Court for the Western District of
Wisconsin. The complaint names Interleukin and eight other
corporations as defendants in an alleged patent infringement lawsuit (Genetics
Technologies Limited vs. Beckman Coulter, Inc., et. al., Civil Action No.
10-CV-00069, W.D. Wis., filed February 11, 2010). We were served with
the complaint on March 24, 2010. The complaint alleges that the
defendants make, use or sell products or services that infringe one or more
claims of the patent owned by GTL, U.S. Patent No. 5,612,179, or the ’179
Patent, which expires on March 10, 2010. In Interleukin’s case, the
complaint alleges that we offer and provide genetic risk assessment testing
services that utilize methods set forth in one or more claims of the ‘179
Patent. We believe that we have substantial defenses to the claims asserted
in the complaint.
Item 4. [RESERVED]
PART
II
Item 5.
Market for Registrant’s Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Market
Information
Our
common stock currently trades under the symbol “ILI” on the NYSE Amex (formerly
known as the NYSE Alternext US). The following table sets forth, for the periods
indicated, the high and low sales prices for our common stock, as reported by
the NYSE Amex.
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2009:
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First
Quarter
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$
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0.50
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$
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0.17
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Second
Quarter
|
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$
|
0.85
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|
$
|
0.21
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Third
Quarter
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$
|
3.00
|
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|
$
|
0.36
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Fourth
Quarter
|
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$
|
1.31
|
|
|
$
|
0.60
|
|
|
|
|
|
|
|
|
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|
|
|
|
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2008:
|
|
|
|
|
|
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First
Quarter
|
|
$
|
1.65
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|
|
$
|
0.94
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Second
Quarter
|
|
$
|
1.75
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|
|
$
|
1.00
|
|
Third
Quarter
|
|
$
|
1.47
|
|
|
$
|
0.80
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Fourth
Quarter
|
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$
|
1.05
|
|
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$
|
0.13
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Stockholders
As of
March 18, 2010, there were approximately 134 stockholders of record and
according to our best estimate, approximately 3,300 beneficial owners of our
common stock.
Dividends
We have
not declared any dividends to date and do not plan to declare any dividends on
our common stock in the foreseeable future. Furthermore, our credit facility
with Pyxis prohibits us from paying cash dividends without Pyxis’
consent.
Sales
of Unregistered Securities
None that
have not been previously reported.
Issuer
Purchases of Equity Securities
None.
Item 6.
Selected Consolidated Financial
Data
The
following table sets forth selected consolidated financial data as of and for
each of the five years ended December 31, 2009. The selected consolidated
financial data as of and for each of the five years in the period ended
December 31, 2009 has been derived from our audited consolidated financial
statements. Prior to the opening of business on July 1, 2009 the Company and its
wholly-owned subsidiary AJG Brands, Inc. sold substantially all of the assets of
AJG Brands, Inc. operating results for AJG Brands, Inc. are reflected in
discontinued operations. This data should be read in conjunction with our
audited consolidated financial statements and related notes that are included
elsewhere in this Annual Report on Form 10-K and with “Management’s
Discussion and Analysis of Financial Condition and Results of Operations”
included in Item 7 below.
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Year Ended December 31,
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2009
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2008
|
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2007
|
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2006
|
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2005
|
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Statement
of Operations Data:
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Continuing
Operations
|
|
|
|
|
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|
|
|
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Total
revenue
|
|
$
|
1,078,430
|
|
|
$
|
2,620,687
|
|
|
$
|
2,827,284
|
|
|
$
|
2,680,762
|
|
|
$
|
22,877
|
|
Cost
of revenue
|
|
|
1,203,647
|
|
|
|
940,241
|
|
|
|
975,770
|
|
|
|
1,212,831
|
|
|
|
—
|
|
Gross
profit (loss)
|
|
|
(125,217
|
)
|
|
|
1,680,446
|
|
|
|
1,851,514
|
|
|
|
1,467,931
|
|
|
|
22,877
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
& development
|
|
|
3,213,115
|
|
|
|
3,560,002
|
|
|
|
2,928,249
|
|
|
|
3,262,349
|
|
|
|
3,127,086
|
|
Selling,
general & administrative
|
|
|
5,575,911
|
|
|
|
5,012,345
|
|
|
|
3,970,869
|
|
|
|
3,616,859
|
|
|
|
2,916,858
|
|
Amortization
of intangibles
|
|
|
115,453
|
|
|
|
100,693
|
|
|
|
73,223
|
|
|
|
54,332
|
|
|
|
36,921
|
|
Total
operating expenses
|
|
|
8,904,479
|
|
|
|
8,673,040
|
|
|
|
6,972,341
|
|
|
|
6,933,540
|
|
|
|
6,080,865
|
|
Loss
from continuing operations
|
|
|
(9,029,696
|
)
|
|
|
(6,992,594
|
)
|
|
|
(5,120,827
|
)
|
|
|
(5,465,609
|
)
|
|
|
(6,057,988
|
)
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
|
10,183
|
|
|
|
158,773
|
|
|
|
414,493
|
|
|
|
275,122
|
|
|
|
131,655
|
|
Interest
Expense
|
|
|
(158,760
|
)
|
|
|
(130,253
|
)
|
|
|
(231,992
|
)
|
|
|
(230,495
|
)
|
|
|
(182,617
|
)
|
Other
income (expense):
|
|
|
—
|
|
|
|
—
|
|
|
|
(456,223
|
)
|
|
|
(461,874
|
)
|
|
|
(461,874
|
)
|
Total
other income (expense)
|
|
|
(148,577
|
)
|
|
|
28,520
|
|
|
|
(273,722
|
)
|
|
|
(417,247
|
)
|
|
|
(512,836
|
)
|
Net
loss from continuing operations before income taxes
|
|
|
(9,178,273
|
)
|
|
|
(6,964,074
|
)
|
|
|
(5,394,549
|
)
|
|
|
(5,882,856
|
)
|
|
|
(6,570,824
|
)
|
Provision
(benefit) for income taxes
|
|
|
—
|
|
|
|
31,000
|
|
|
|
(31,000
|
)
|
|
|
—
|
|
|
|
—
|
|
Net
loss from continuing operations
|
|
$
|
(9,178,273
|
)
|
|
$
|
(6,933,074
|
)
|
|
$
|
(5,425,549
|
)
|
|
$
|
(5,882,856
|
)
|
|
$
|
(6,570,824
|
)
|
Discontinued
Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit
(loss) from discontinued operations, net of income taxes
|
|
|
(27,928
|
)
|
|
|
281,689
|
|
|
|
(793,236
|
)
|
|
|
(1,063,900
|
)
|
|
|
—
|
|
Loss
on sale of discontinued operations including impairment charge of
$3,251,838 in 2009
|
|
|
(1,346,202
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Profit
(loss) from discontinued operations
|
|
$
|
(1,374,130
|
)
|
|
$
|
281,689
|
|
|
$
|
(793,236
|
)
|
|
$
|
(1,063,900
|
)
|
|
|
—
|
|
Net
loss
|
|
$
|
(10,552,403
|
)
|
|
$
|
(6,651,385
|
)
|
|
$
|
(6,218,785
|
)
|
|
$
|
(6,946,756
|
)
|
|
$
|
(6,570,824
|
)
|
Basic
and diluted net profit (loss) per common share from:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(0.29
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.20
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.28
|
)
|
Discontinued
operations
|
|
$
|
(0.04
|
)
|
|
$
|
0.01
|
|
|
$
|
(0.02
|
)
|
|
$
|
(0.04
|
)
|
|
|
—
|
|
Net
loss
|
|
$
|
(0.33
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.28
|
)
|
Weighted
average common shares outstanding, basic and diluted
|
|
|
32,007,826
|
|
|
|
31,354,198
|
|
|
|
27,723,754
|
|
|
|
25,340,107
|
|
|
|
23,702,967
|
|
|
|
Year Ended December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
Selected
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
906,248
|
|
|
$
|
4,952,481
|
|
|
$
|
7,646,468
|
|
|
$
|
10,082,919
|
|
|
$
|
3,415,174
|
|
Working
Capital
|
|
$
|
(518,100
|
)
|
|
$
|
3,199,323
|
|
|
$
|
3,849,973
|
|
|
$
|
5,602,760
|
|
|
$
|
574,914
|
|
Total
Assets
|
|
$
|
3,069,463
|
|
|
$
|
12,154,388
|
|
|
$
|
16,385,949
|
|
|
$
|
22,630,285
|
|
|
$
|
4,970,075
|
|
Long
term debt and capital lease obligations, less current
portion
|
|
$
|
7,000,000
|
|
|
$
|
4,000,000
|
|
|
|
—
|
|
|
|
—
|
|
|
$
|
1,671,588
|
|
Stockholders'
(deficit) equity
|
|
$
|
(5,764,628
|
)
|
|
$
|
4,482,427
|
|
|
$
|
10,192,414
|
|
|
$
|
13,785,931
|
|
|
$
|
283,745
|
|
Item 7.
Management’s Discussion and Analysis
of Financial Condition and Results of Operations
The
following discussion of our financial condition and results of operations should
be read in conjunction with our “Selected Consolidated Financial Data” and the
audited Consolidated Financial Statements and the notes thereto included
elsewhere in this Annual Report on Form 10-K.
General
Overview and Trends
Interleukin
Genetics, Inc. is a personalized health company that develops condition-focused,
unique genetic tests. Our overall mission is to provide test products that can
help individuals improve or maintain their health through preventive measures.
Our vision is to use the science of applied genetics to empower individuals and
physicians to better understand the set of actions and steps necessary to guide
the best lifestyle and treatment options. We believe that the science of applied
genetics can help companies provide improved services to their consumers, and
assist in improving outcomes in drug development and use.
2009 was
a year of change and directional focus for our company. We initiated a product
launch and closed three significant transactions that have impacted or we expect
will impact our business. On June 8, 2009 we launched our new Inherent
Health
®
brand of
genetic tests and related programs including the first-of-its-kind test for
weight management that identifies an individual’s genetic tendencies for weight
gain and metabolism. In addition, the brand launch offers customers a full suite
of affordable, easy-to-use and meaningful genetic tests in heart health,
nutritional needs, and bone health, which we launched in December 2009. In
addition to the four Inherent Health
®
test
products, we provide the PST
®
periodontal disease risk assessment test through a Licensing Agreement with
OralDNA Labs, Inc. a Quest Diagnostics Inc. Company. To support the Inherent
Health
®
brand
launch, we implemented a fully functional web presence with e-commerce
capabilities. Genetic tests may be purchased through our website. A nationwide
advertising campaign consisting of television, print and internet media was
started in the third quarter of 2009, which we anticipated would allow us to
better understand the proper media mix for this brand. A third party support and
call center was put in place in advance of the advertising campaign. The
nationwide advertising campaign ran for two weeks and cost us approximately $0.8
million. The media campaign provided strategic direction to our product
marketing efforts. We learned from the campaign that television is not the
primary media for our success and based on the experience gained from the
campaign, we do not plan on utilizing significant media resources to market our
products. Distribution of our tests and related technology in the short term
will focus on:
|
·
|
partnering
with national and international companies for the sale and distribution of
our genetic test products
|
|
·
|
partnering
with biotechnology companies in the area of drug
discovery
|
|
·
|
health
care professional partnerships
|
In addition, we will continue to offer
our products through our e-commerce web site.
On April
6, 2009, we entered into a licensing agreement with LABEC Pharma, S.L. to market
and sell our Heart Health genetic test throughout Spain and Portugal. As part of
the agreement, the test will be marketed by LABEC Pharma and the tests will be
processed at our CLIA certified laboratory at our corporate headquarters in
Waltham, Massachusetts. On January 19, 2010 we announced that LABEC Pharma has
met European regulatory guidelines and will begin to sell our Heart Health
genetic test in Spain and Portugal under the product name, Cardio
Health™.
Up to and
including June 30, 2009, we had two primary business segments that
included:
|
·
|
Personalized Health
Segment
– this segment conducts, researches, develops, markets and
sells genetic tests panels primarily in inflammatory and metabolic areas
to provide better insight into health, wellness and disease. Following the
sale of substantially all of the Alan James Group business and assets
prior to the opening of business on July 1, 2009, the Personalized Health
segment became our only business
segment.
|
|
·
|
Consumer Products
Segment
– this segment was comprised of the Alan James Group
business assets, which we sold prior to the opening of business on July 1,
2009, and was focused on developing, selling and marketing nutritional
supplements and products into retail consumer channels. Following the sale
of substantially all of the Alan James Group business and assets, the
Consumer Products segment ceased to
exist.
|
Prior to
the opening of business on July 1, 2009 we sold substantially all of the Alan
James Group business and assets of our wholly-owned subsidiary AJG Brands, Inc.
to Pep Products, Inc., a subsidiary of Nutraceutical Corporation, for
approximately $4.6 million in cash. The proceeds consisted of a $0.2 million
holdback reflected in other assets and $4.4 million cash which was received on
July 1, 2009. The assets sold consisted primarily of accounts receivable,
inventories, property and equipment and other assets related to the business.
The buyer did not assume accounts payable and accrued liabilities. Subsequent to
the closing, AJG Brands, Inc.’s name was changed to Interleukin Brands, Inc.
(“IBI”). The non acquired assets remaining in IBI consist primarily of certain
accounts receivable and inventory. IBI remained a wholly-owned subsidiary of
Interleukin until December 29, 2009, when it was merged into Interleukin. We
have fully reserved for all non-acquired inventory and accounts receivable in
our financial statements. As a requirement of the transaction, we are prohibited
from continuing to operate in a business competitive to the one previously
conducted by AJG Brands, Inc., which primarily developed, marketed and sold
nutritional supplements and related products into retail consumer channels. The
sale of substantially all of the Alan James Group business and assets, which
previously comprised the Consumer Products segment of our business, will allow
us to focus our resources and attention exclusively on our genetic test business
by developing new and selling our existing genetics tests to the growing
personalized health market. From July 1, 2009 through December 31, 2009 we did
not receive any revenue from the Alan James Group reflected in discontinued
operations. We expect to continue to incur expenses until remaining liabilities
primarily related to non acquired customer in store inventory is settled. We are
working with these retailers to settle the remaining inventory which we believe
is adequately reserved for in the financial statements. We are now focusing on
genetic test development and commercialization which was formerly defined as our
Personalized Health segment and is reflected as continuing
operations.
In
addition to completing the merger of the IBI subsidiary with Interleukin
Genetics, Inc. our wholly owned inactive subsidiary, Interleukin Genetics
Laboratory Services, Inc. was also merged into Interleukin Genetics, Inc. on
December 29, 2009. The subsidiary had not conducted any business and had no
assets or liabilities. As of December 29, 2009 we have no
subsidiaries.
On
October 26, 2009, we entered into a Merchant Network and Channel Partner
Agreement with Amway Corp. d/b/a Amway Global (“Amway Global”), a subsidiary of
Alticor Inc. Pursuant to this Agreement, Amway Global will sell the Company’s
Inherent Health
®
brand of
genetic tests through its e-commerce Web site via a hyperlink to our e-commerce
site. Amway Global will receive a commission equal to a percentage of net sales
received by us from Amway Global customers. We anticipate the Merchant Network
and Channel Partner Agreement in combination with the launch of our Inherent
Health
®
brand of
genetic tests and related programs in June 2009 will help us achieve the goal of
increasing our genetic test sales.
Our
genetic test business contributes toward our overall mission of developing tests
and products that can help individuals improve and maintain their health through
preventive measures. We plan to pursue this by:
|
·
|
developing
genetic risk assessment tests for use in multiple indications, countries
and various demographics; and
|
|
·
|
processing
genetic risk assessment tests in our CLIA-certified lab or in those of
sublicenses.
|
In 2006,
sales of our genetic test products began under marketing and other business
arrangements with Alticor. Alticor is a significant customer, representing
virtually all of our genetic test revenues and contract research revenue for
each of the years ended December 31, 2009, 2008 and 2007. Revenues from Alticor
accounted for approximately 88%, 94% and 99% of continuing operations revenues
in 2009, 2008 and 2007, respectively.
We have
traditionally spent approximately $3-4 million annually on research and
development. We completed our research agreements with Alticor in 2009 and plan
to dedicate more of our resources to our own product development efforts. We
expect our research & development expenses to decrease as we focus more on
our own development and commercialization efforts. This is different than in
prior years our development focus was concentrated in research and development
to bring new test configurations to market. As a result of the launch of our
Inherent Health
®
brand of
genetic tests, we expect corporate selling, general, marketing and
administrative expenses associated with our genetic test products to increase in
2010 and beyond. As of December 31, 2009, we had $7.3 million of borrowings
available under our credit line with Pyxis Innovations, Inc., an affiliate of
Alticor, which permits borrowing any time prior to January 1, 2011. On February
1, 2010 the credit line was extended to permit borrowing any time prior to June
30, 2011. On February 1, 2010 we borrowed an additional $2.0 million which
leaves $5.3 million available under our credit line.
On
February 25, 2008, we entered into our most recent research agreement,
known as RA8, with Access Business Group International LLC (ABG), a
subsidiary of Alticor. RA8 encompasses four primary areas: osteoporosis,
cardiovascular disease, nutrigenomics, and dermagenomics. On January 31, 2009,
the Company entered into an amendment to RA8, which extends the term from a
maximum of six months to eight months terminating on September 30, 2009. We
received an additional $200,316 on March 31, 2009 per the amendment to complete
ongoing research. See financial statement footnote 6 for a discussion of our
strategic alliance with Alticor. As of September 30, 2009, we had completed the
clinical studies under RA8 which aim to correlate SNP gene variations to the
risk of osteoporosis or cardiovascular disease in Asian populations. Other
studies conducted in North American populations identified genetic factors that
influence athletic performance (nutrigenomics) and skin health, such as
wrinkles, elasticity, aging (dermagenomics), for the purpose of developing
products to enhance healthy aging. Under the terms of RA8, ABG paid us
$1.2 million during 2008 for the research. In addition, we recognized
approximately $800,000 of revenue which was unused from prior research
agreements with Alticor and its subsidiaries. No additional research agreements
are planned with Alticor.
On
September 23, 2009, we announced top line positive results from a retrospective
clinical study on weight management using patients who participated in a diet
study previously reported in the Journal of The American Medical Association.
Our study demonstrated that individuals following diets matched to their
genotype, as determined by our weight management genetic test, showed
statistically significant greater weight loss (6.2% versus 2.4% p<0.013 at 12
months) and other benefits at all time points (2, 6 and 12 months) when compared
to individuals on diets not matched to their genotype.
In the
genetic test business, competition is in flux and the markets and customer base
are not well established. Adoption of new technologies by consumers requires
substantial market development and customer education. Historically, we have
focused on our relationship with our primary customer, Alticor, a significant
direct marketing company, in order to assist us in developing the market for our
products and educating our potential customers. Our challenge in 2010 and beyond
will be to develop the market for our own personalized health products. We have
begun to allocate considerable resources to our own brand of consumer products,
including the June 2009 launch of our new Inherent Health
®
brand of
genetic tests and related programs. Due to the early stage of these initiatives,
we cannot predict with certainty fluctuations we may experience in our test
revenues or whether revenues derived from the Merchant Network and Channel
Partner Agreement with Amway Global will ever be material or if material, will
be sustained in future periods.
Liquidity
and Capital Resources
As of
December 31, 2009, we had cash and cash equivalents of $0.9 million and
borrowings available under our credit facility of $7.3 million, which
permits borrowing at any time prior to June 30, 2011. On February 1, 2010 we
borrowed an additional $2.0 million leaving $5.3 million of available credit. In
connection with the closing of the sale of substantially all of the Alan James
Group business and assets of AJG Brands, Inc., prior to the opening of business
on July 1, 2009, we received $4.4 million of cash proceeds on July 1,
2009.
Cash used
in continuing operations was $6.5 million for the year ended December 31, 2009,
as compared to $5.6 million for the year ended December 31, 2008. Cash used
in operations is primarily impacted by operating results and changes in working
capital, particularly the timing of the collection of receivables, inventory
levels and the timing of payments to suppliers.
Prior to
the sale of substantially all of the Alan James Group business and assets, we
received positive operating cash flow from the retail sale of supplements. The
sale of assets provided cash of approximately $4.4 million on July 1, 2009. The
combination of positive operating cash flow from the operations of The Alan
James Group in the years 2006-2009 and sale proceeds reduced our need for
borrowings from our credit line with Alticor. As we build our genetic test
business the need for capital may increase due to the sale of the supplement
business. Beyond our credit line we have no assurance we will be able to raise
sufficient capital from the public markets or other financing alternatives. On
December 23, 2009, we filed a shelf registration statement with the SEC for the
issuance of common stock, preferred stock, various series of debt securities
and/or warrants to purchase any of such securities, either individually or in
units, with a total value of up to $75 million, from time to time at prices and
on terms to be determined at the time of such offerings. The filing was declared
effective on January 5, 2010. On March 5, 2010, we entered into a definitive
agreement with certain institutional investors to sell $5.3 million of
securities in a registered direct offering. The investors purchased an aggregate
of 4,375,002 units for $1.20 per unit, with each unit consisting of a share of
common stock and a warrant to purchase 0.40 of a share of common stock. The
warrants are exerciseable at $1.30 per share and expire in five years. Net
proceeds to us after fees and expenses were approximately $4.9
million.
A
significant use of cash in the year ended December 31, 2008 was a payment of
$1.2 million, relating to the settlement of purchase obligations with the Alan
James Group, $0.6 million of which had been accrued prior to 2008 and is
reflected as being paid in net cash used in continuing operation activities in
the year ended December 31, 2008. The remaining $0.6 million is reflected in net
cash used in investing activities of our continuing operations as described
below. The increase of $0.9 million of cash used in continuing operations is
primarily attributable to the closing costs related to the sale of substantially
all of the Alan James Group business and assets, as well as costs of
advertising, media and product development costs related to the launch of our
Inherent Health
®
brand of
genetic tests.
Cash used
in investing activities of our continuing operations was $0.6 million for the
year ended December 31, 2009, compared to $1.1 million for the year ended
December 31, 2008. The most significant use of cash in investing activities
during the year ended December 31, 2008 was the settlement of claims related to
the acquisition of the assets and business of the Alan James Group as described
above. As a result of the settlement, we paid additional consideration of $0.6
million. Capital additions were $0.7 million for the twelve months ended
December 31, 2009, compared to $0.2 million for the twelve months ended December
31, 2008. The increase in capital additions primarily consists of new commercial
laboratory equipment installed and validated during 2009, which allows for high
volume processing of genetic test samples.
Cash
provided by financing activities of our continuing operations was $3.1 million
for the year ended December 31, 2009, compared to $4.0 million for the year
ended December 31, 2008. On May 29, 2009 we received proceeds from the issuance
of a note payable in the amount of $1.0 million under our existing credit
facility with Pyxis. On November 9, 2009 we received an additional $2.0 million
under the credit facility. On June 10, 2008 we received $4.0 million under the
same credit facility. We received approximately $73,000 and $18,000,
respectively from the exercise of stock options and stock purchases through the
employee stock purchase plan for the years ended December 31, 2009 and
2008.
On
December 23, 2008, we were notified of our failure to comply with the NYSE Amex,
hereinafter referred to as the Exchange, continued listing standards under
section 1003 of the Exchange’s Company Guide. Specifically, the Exchange noted
our failure to comply with section 1003(a) (iii) of the Company Guide because
our stockholders’ equity was less than $6,000,000 and we had losses from
continuing operations and net losses in our five most recent fiscal years. The
notice was based on a review by the Exchange of publicly available information,
including our Quarterly Report on Form 10-Q for the quarter ended September 30,
2008. As of December 31, 2008, our stockholders equity was $4.5 million, and as
of December 31, 2009 we had a stockholders’ deficit of $5.8 million. On January
27, 2009, we submitted a plan to the exchange to meet the continued listing
requirements. The plan consists of several elements, but is primarily focused on
increasing the sales of our products and services and raising additional equity
capital. On March 27, 2009, we were notified that the Exchange found our plan to
regain compliance with the continued listing standards to be unacceptable. We
filed an appeal for an oral hearing and submitted a revised plan to the
Exchange. On May 11, 2009, the Exchange notified us that the Exchange accepted
our redrafted plan of compliance, without a hearing, and granted us an extension
until December 31, 2009 to regain compliance with the continued listing
standards. In December 2009 we provided more information to the Exchange and
requested an extension. The Exchange continued to review our progress toward
regaining compliance and on March 17, 2010 granted us an extension until June
23, 2010 to regain compliance. Failure to make progress consistent with the plan
or to regain compliance with the continued listing standards could result in
delisting from the Exchange, which could significantly impact our ability to
raise additional capital.
We
currently do not have any commitments for any additional material capital
purchases.
Prior to
June 30, 2009, we generated operating cash by sales of consumer products and
subsequent to that date we continue to generate cash from the sale of genetic
tests, royalties, and reimbursements for funded research. Subsequent to June 30,
2009, pursuant to the asset purchase agreement with the Alan James Group, we are
prohibited from continuing to operate in a business competitive to the one
previously conducted by AJG Brands, Inc., which primarily developed, marketed
and sold nutritional supplements and related products into retail consumer
channel. The amount of operating cash we generate is not currently sufficient to
continue to fund and grow our operations. In addition to funds generated by our
operations, we have a $14.3 million credit facility with Pyxis, under which we
had $7.3 million in borrowings available as of December 31, 2009. On February 1,
2010 we borrowed an additional $2.0 million leaving borrowings available of $5.3
million under the credit facility. Clinical studies and other research and
development activities may require cash outflows that depend on the timing of
activities.
We
believe our success depends on our ability to have sufficient capital and
liquidity to achieve our objectives of closing negotiations with partners and
creating additional distribution channels for our genetic testing products and
technology. In addition to our current operating line of credit we will have to
raise additional capital. At the current time we are unable to cover our
operating expenses. Even though we are experiencing sales increases in our
genetic testing business we must take additional steps to reduce our operating
costs. In 2009 we reduced our headcount in non essential areas. We are currently
attempting to sublease approximately one-third of our 19,000 square feet of
office space. The space includes offices and a laboratory that is not being
used. We have significantly reduced our research and development programs to
only those that focus on technology related to deals with potential commercial
partners. We have taken steps to reduce our corporate administrative expenses by
working with or seeking new vendors who offer the same service for a better
cost. While we expect that our current and anticipated financial resources,
including the amount available under our credit facility with Pyxis and the $4.9
million in net proceeds we received from our March 2010 registered direct
offering, are adequate to maintain our current and planned operations for at
least the next 18 months, we anticipate we will need substantial additional
funds in the future which we intend to obtain from operations, alliances or
raising additional capital, but such funding may not be available on terms
acceptable to us, or at all. After taking into account the 4,375,002 shares of
common stock and warrants to purchase 1,750,000 shares of common stock we issued
in the March 2010 registered direct offering, we have approximately $65.5
million of securities available for sale under our effective shelf registration
statement, although we may be limited by the rules and regulations of the SEC
and the NYSE Amex in the amount of securities we may offer under this
registration statement. Even if we are unsuccessful in raising addition capital
we may not be able to raise enough capital to cover our ongoing operating
expenses and may be forced to seek other strategic alternatives.
We have
no financial covenants as part of our credit facility with Pyxis. As of December
31, 2009, we had $7.0 million outstanding under the credit facility, which is
reflected as long term debt on our balance sheet and is convertible, at the
option of Pyxis into shares of our common stock at a price of $5.6783 per share.
On February 1, 2010, we drew down an additional $2.0 million under the credit
facility with Pyxis and issued a convertible promissory note to Pyxis in that
amount. We currently have $9.0 million outstanding under the credit facility,
and we have $5.3 million available to us to borrow under the credit
facility.
A summary
of our contractual obligations as of December 31, 2009 is included in the table
below:
|
|
Payments Due By Period (000’s)
|
|
Contractual Obligations
|
|
Total
|
|
|
Less than
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
More than
5 Years
|
|
Long-Term
Debt Obligations
|
|
$
|
7,000
|
|
|
$
|
—
|
|
|
$
|
7,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating
Lease Obligations
|
|
|
1,966
|
|
|
|
452
|
|
|
|
1,395
|
|
|
|
119
|
|
|
|
—
|
|
TOTAL
|
|
$
|
8,966
|
|
|
$
|
452
|
|
|
$
|
8,395
|
|
|
$
|
119
|
|
|
$
|
—
|
|
Results
of Operations
|
|
Year Ended December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
Personalized
health – continuing operations
|
|
|
|
|
|
|
|
|
|
Genetic
testing
|
|
$
|
505,913
|
|
|
$
|
409,452
|
|
|
$
|
779,238
|
|
Contract
research & development
|
|
|
545,847
|
|
|
|
2,061,149
|
|
|
|
2,028,030
|
|
Other
|
|
|
26,670
|
|
|
|
150,086
|
|
|
|
20,016
|
|
Total
revenue from continuing operations
|
|
|
1,078,430
|
|
|
|
2,620,687
|
|
|
|
2,827,284
|
|
Cost
of revenue
|
|
|
1,203,647
|
|
|
|
940,241
|
|
|
|
975,770
|
|
Gross
margin
|
|
|
(125,217
|
)
|
|
|
1,680,446
|
|
|
|
1,851,514
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
& development
|
|
|
3,213,115
|
|
|
|
3,560,002
|
|
|
|
2,928,249
|
|
Selling,
general & administrative
|
|
|
5,575,911
|
|
|
|
5,012,345
|
|
|
|
3,970,869
|
|
Amortization
of intangibles
|
|
|
115,453
|
|
|
|
100,693
|
|
|
|
73,223
|
|
Other
(income) expense
|
|
|
148,577
|
|
|
|
(28,520
|
)
|
|
|
273,722
|
|
Total
expenses
|
|
|
9,053,056
|
|
|
|
8,644,520
|
|
|
|
7,246,063
|
|
Net
loss from continuing operations before income taxes
|
|
|
(9,178,273
|
)
|
|
|
(6,964,074
|
)
|
|
|
(5,394,549
|
)
|
Benefit
for income taxes
|
|
|
—
|
|
|
|
31,000
|
|
|
|
(31,000
|
)
|
Net
loss from continuing operations
|
|
$
|
(9,178,273
|
)
|
|
$
|
(6,933,074
|
)
|
|
$
|
(5,425,549
|
)
|
Consumer
products – discontinued operations
|
|
|
|
|
|
|
|
|
|
Consumer
product revenue
|
|
|
3,580,169
|
|
|
|
7,394,293
|
|
|
|
6,873,209
|
|
Cost
of revenue
|
|
|
1,892,815
|
|
|
|
3,797,677
|
|
|
|
3,723,676
|
|
Gross
margin
|
|
|
1,687,354
|
|
|
|
3,596,616
|
|
|
|
3,149,533
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general & administrative
|
|
|
1,206,714
|
|
|
|
2,022,023
|
|
|
|
2,397,104
|
|
Amortization
of intangibles
|
|
|
4,010
|
|
|
|
1,234,745
|
|
|
|
1,578,021
|
|
Other
(Income)expenses
|
|
|
451,558
|
|
|
|
1,057
|
|
|
|
(16,856
|
)
|
Loss
on discontinued operations
|
|
|
1,346,202
|
|
|
|
—
|
|
|
|
—
|
|
Net
(Income)expenses
|
|
|
3,008,484
|
|
|
|
3,257,825
|
|
|
|
3,958,269
|
|
Net
income(loss) from discontinued operations before income
taxes
|
|
|
(1,321,130
|
)
|
|
|
338,791
|
|
|
|
(808,736
|
)
|
Provision
for income taxes
|
|
|
(53,000
|
)
|
|
|
(57,102
|
)
|
|
|
15,500
|
|
Net
income(loss) from discontinued operations
|
|
$
|
(1,374,130
|
)
|
|
$
|
281,689
|
|
|
$
|
(793,236
|
)
|
Combined
continuing and discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenue
|
|
|
4,658,599
|
|
|
|
10,014,980
|
|
|
|
9,700,493
|
|
Cost
of revenue
|
|
|
3,096,462
|
|
|
|
4,737,918
|
|
|
|
4,699,446
|
|
Gross
margin
|
|
|
1,562,137
|
|
|
|
5,277,062
|
|
|
|
5,001,047
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
& development
|
|
|
3,213,115
|
|
|
|
3,560,002
|
|
|
|
2,928,249
|
|
Selling,
general & administrative
|
|
|
6,782,625
|
|
|
|
7,034,368
|
|
|
|
6,367,973
|
|
Amortization
of intangibles
|
|
|
119,463
|
|
|
|
1,335,438
|
|
|
|
1,651,244
|
|
Other
(income) expense
|
|
|
600,135
|
|
|
|
(27,463
|
)
|
|
|
256,866
|
|
Loss
on discontinued operations
|
|
|
1,346,202
|
|
|
|
—
|
|
|
|
—
|
|
Total
expenses
|
|
|
12,061,540
|
|
|
|
11,902,345
|
|
|
|
11,204,332
|
|
Net
loss before income taxes
|
|
|
(10,499,403
|
)
|
|
|
(6,625,283
|
)
|
|
|
(6,203,285
|
)
|
Provision
for income taxes
|
|
|
(53,000
|
)
|
|
|
(26,102
|
)
|
|
|
(15,500
|
)
|
Net
loss
|
|
$
|
(10,552,403
|
)
|
|
$
|
(6,651,385
|
)
|
|
$
|
(6,218,785
|
)
|
Basic
and diluted net profit (loss) per common share from:
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(0.29
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.20
|
)
|
Discontinued
operations
|
|
$
|
(0.04
|
)
|
|
$
|
0.01
|
|
|
$
|
(0.02
|
)
|
Net
loss
|
|
$
|
(0.33
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.22
|
)
|
Weighted
average common shares outstanding
|
|
|
32,007,826
|
|
|
|
31,354,198
|
|
|
|
27,723,754
|
|
Years
Ended December 31, 2009 and 2008
Continuing
Operations
Total revenue from our continuing
operations for the year ended December 31, 2009 was $1.1 million, compared to
$2.6 million for the year ended December 31, 2008. The decrease of $1.5 million
or 58.8% is primarily attributable to a decrease in contract research revenue
and royalty revenue offset by an increase in genetic test revenue. Contract
research revenue decreased $1.5 million primarily due to the completion in 2009
of sponsored projects with reimbursable research expenses. Genetic testing
revenue was $0.5 million in the year ended December 31, 2009, compared to $0.4
million in the year ended December 31, 2008, the increase of $0.1million or
23.6% is primarily attributable to the launch of our Inherent Health
®
brand of
genetic tests, which commenced in June 2009.
Revenues from Alticor represented
approximately 87.7% and 93.9%, respectively of our revenues from continuing
operations for the years ended December 31, 2009 and 2008.
Cost of
revenue from continuing operations for the year ended December 31, 2009 was $1.2
million, or 111.6% of its revenue, compared to $0.9 million, or 35.9% of its
revenue, for the year ended December 31, 2008. The significant increase in the
cost of revenue as a percentage of revenue is primarily attributable to
increased fixed costs associated with our genetic testing laboratory
notwithstanding decreases in our revenue. Increased fixed costs include supplies
and depreciation related to the installation of new high volume genetic testing
equipment. In addition lab personnel are spending significantly more of their
time processing tests as no further research agreements with Alticor are in
place.
Gross margin from continuing operations
for the year ended December 31, 2009 was a loss of $125,000, or 11.6% of its
revenue, compared to a profit of $1.7 million, or 64.1% of its revenue for the
year ended December 31, 2008. The decrease in gross margin of $1.8 million, or
107.5%, is primarily attributable to a reduction in contract research revenue
and royalty revenue offset by an increase in genetic testing revenue for the
year ended December 31, 2009, compared to the year ended December 31, 2008.
Fixed costs increased during the year ended December 31, 2009 due to the
purchase and installation of new high volume genetic testing equipment, which we
expect to be absorbed with changes in volume of tests performed. The equipment
will allow for higher volume processing. No such costs were recognized in the
twelve months ended December 31, 2008.
Research
and development expenses from continuing operations were $3.2 million for the
year ended December 31, 2009, compared to $3.6 million for the year ended
December 31, 2008. The decrease of $0.4 million, or 9.7%, is primarily
attributable to decreases in clinical trial expenses related to our research
agreements with Alticor and lower consulting expenses offset by increased
separation costs and increased expenses related to our patent
portfolio
Selling,
general and administrative expenses from continuing operations were $5.6 million
for the year ended December 31, 2009 compared to $5.0 million for the year ended
December 31, 2008. The increase of $0.6 million, or 11.2%, is primarily
attributable to increased product development and advertising expenses for our
Inherent Health
®
brand of
genetic test and increased headcount, offset by decreased expenses relating to
administrative support consultants.
Interest
expense from continuing operations was $159,000 for the year ended December 31,
2009, as compared to $130,000 for the year ended December 31, 2008. The increase
in interest expense of $29,000 is primarily attributable to interest expense
associated with borrowings on our credit facility with Pyxis.
Interest
income from continuing operations was $10,000 for the year ended December 31,
2009, as compared to $159,000 for the year ended December 31, 2008. The decrease
in interest income of $149,000 is primarily attributable to the decrease in our
cash balance in combination with lower interest being earned on available cash
balances. The current financial market conditions have significantly reduced the
interest rate we are able to earn on our cash and cash equivalent
balances.
Years
Ended December 31, 2008 and
2007
Total
revenue from our continuing operations for the year ended December 31, 2008 was
$2.6 million, compared to $2.8 million for the year ended December 31, 2007. The
decrease of $0.2 million or 7.3% is attributable to a decrease in genetic test
revenue offset by an increase in royalty revenue. Contract research revenue
increased slightly due to sponsored projects with reimbursable research
expenses. Genetic testing revenue was $0.4 million in the year ended December
31, 2008, compared to $0.8 million in the year ended December 31, 2007 or a
decrease of $0.4 million or 47.5% is primarily attributable to a decrease in
customer demand which was higher during the products’ initial launch in
2007.
Revenues from Alticor represented
approximately 93.9% and 98.8%, respectively of our revenues from continuing
operations for the years ended December 31, 2008 and 2007.
Cost of revenue from continuing
operations for the year ended December 31, 2008 was $0.9 million, or 35.9% of
its revenue, compared to $1.0 million, or 34.5% of its revenue, for the year
ended December 31, 2007. The decrease of $0.1 million is attributable to
increased laboratory operating costs and rent offset by lower labor and lab
supply costs.
Gross margin from continuing operations
for the year ended December 31, 2008 was $1.7 million, or 64.1% of its revenue,
compared to $1.9 million, or 65.5% of its revenue, for the year ended December
31, 2007. The decrease in gross margin of $0.2 million, or 9.2%, is attributable
to a reduction in revenue and offset by an increase in royalty revenue for the
year ended December 31, 2008.
Research and development expenses from
continuing operations were $3.6 million for the year ended December 31, 2008
compared to $2.9 million for the year ended December 21, 2007. The increase of
$0.7 million, or 21.6%, is primarily attributable to an increase in expenses
relating to our sponsored research agreement with Yonsei University, combined
with increased costs related to our patent portfolio, partially offset by a
reduction in research consulting expenses.
Selling,
general and administrative expenses from continuing operations were $5.0 million
for the year ended December 31, 2008 compared to $4.0 million for the year ended
December 31, 2007. The increase of $1.0 million, or 26.2%, is primarily
attributable to increased promotional and advertising expenses plus additional
compensation expenses due to our increased headcount. These expense increases
were partially offset by a reduction in settlement expenses relating to the
acquisition of The Alan James Group, of which $.6 million was accrued in 2007
and no such expenses were accrued in 2008.
Interest
expense from continuing operations was $130,000 for the year ended December 31,
2008, as compared to $232,000 for the year ended December 31, 2007. The decrease
in interest expense of $102,000 is primarily attributable to decreased interest
expense associated with borrowings under our credit facility with Pyxis, as
Pyxis converted a portion of the borrowings into shares of our common stock in
2008.
Interest
income from continuing operations was $159,000 for the year ended December 31,
2008, as compared to $415,000 for the year ended December 31, 2007. The decrease
in interest income of $256,000 is primarily attributable to the decrease in cash
balance with lower interest being earned on available cash balances. Current
financial market conditions in 2008 significantly reduced the interest rate we
were able to earn on our cash and cash equivalent balances.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are
based upon our consolidated financial statements. The preparation of these
financial statements and related disclosures in conformity with accounting
principles generally accepted in the United States of America requires us to (i)
make judgments, assumptions and estimates that affect the reported amounts of
assets, liabilities, revenue and expenses; and (ii) disclose contingent assets
and liabilities. A critical accounting estimate is an assumption that could have
a material effect on our consolidated financial statements if another, also
reasonable, amount were used or a change in the estimates is reasonably likely
from period to period. We base our accounting estimates on historical experience
and other factors that we consider reasonable under the circumstances. However,
actual results may differ from these estimates. To the extent there are material
differences between our estimates and the actual results, our future financial
condition and results of operations will be affected. Our most critical
accounting policies and estimates upon which our financial condition depends,
and which involve the most complex or subjective decisions or assessments are
the following:
Revenue
Recognition:
Revenue
from genetic testing services is recognized when there is persuasive evidence of
an arrangement, service has been rendered, the sales price is determinable and
collectability is reasonably assured. Service is deemed to be rendered when the
results have been reported to the individual who ordered the test. To the extent
that tests have been prepaid but results have not yet been reported, recognition
of all related revenue is deferred. As of December 31, 2009 and December 31,
2008, we had deferred revenue of $108,000 and $80,000, respectively, for tests
that have been prepaid but results have not yet been reported.
Revenue
from product sales is recognized when there is persuasive evidence of an
arrangement, delivery has occurred and title and risk of loss have transferred
to the customer, the sales price is determinable and collectability is
reasonably assured. The Company has no consignment sales. Product revenue is
reduced for allowances and adjustments, including returns, discontinued items,
discounts, trade promotions and slotting fees.
Revenue
from contract research and development is recognized over the term of the
contract as we perform our obligations under that contract (including revenue
from Alticor, or related party).
Allowance
for Sales Returns:
We analyze sales returns in accordance
with the provisions of FASB ASC 605,
Revenue Recognition.
We are
able to make reasonable and reliable estimates based on the buying patterns of
the end-users of its products based on sales data received. We believe we have
sufficient interaction with and knowledge of our customers, industry trends and
industry conditions to adjust the accrual for returns when
necessary.
At
December 31, 2009, we have fully reserved for any potential sales returns and
discontinued items applicable to balance in the non-acquired accounts resulting
from our sale of substantially all of the assets of the Alan James Group
business. The reserve of approximately $1.0 million is deemed to be adequate and
no additional amounts were added at December 31, 2009. Payments of approximately
$0.3 million were made that directly related to the product returns from non
acquired accounts as of December 31, 2009.
Trade
Promotions
Pursuant
to the asset purchase agreement in connection with the sale of substantially all
of the Alan James Group business and assets, we fully accrued for the
approximately $150,000 of agreed upon trade promotions implemented prior to June
30, 2009. At December 31, 2009 the balance of trade promotions estimated to be
due in the future was $70,859.
Accounts
Receivable
Pursuant to the asset purchase
agreement in connection with the sale of substantially all of the Alan James
Group business and assets we retained non acquired accounts receivable in the
amount of $180,605 which was fully reserved for as uncollectible at June 30,
2009. At December 31, 2009, the balance in non acquired accounts receivable was
$0 as all remaining accounts amounting to $107,000 were deemed uncollectable and
were applied to the reserve. Prior to the acquisition trade accounts receivable
were stated at their estimated net realizable value, which is generally the
invoiced amount less any estimated discount related to payment terms. We offered
our Consumer Product customers a 2% cash discount if payment is made within
30 days of the invoice date, however, most customers take the discount
regardless of when payment occurs.
Inventory:
We value
our inventory at the lower of cost or market. We monitor our inventory and
analyze it on a regular basis. Cycle counts are taken periodically to verify
inventory levels. In addition, we analyze the movement of items within our
inventory in an effort to determine the likelihood that inventory will be sold
or used before expiration dates are reached. We provide an allowance against
that portion of inventory that we believe is unlikely to be sold or used before
expiration dates are reached. An adverse change in any of these factors may
result in the need for additional inventory allowance.
Stock-based
compensation:
We account for our stock-based
compensation expense in accordance with FASB ASC 718,
Compensation – Stock
Compensation
. The standard addresses all forms of share-based payment
(SBP) awards, including shares issued under employee stock purchase plans, stock
options, restricted stock and stock appreciation rights. We expense SBP awards
with compensation cost for SBP transactions measured at fair value. Compensation
cost for the portion of awards for which the requisite service has not been
rendered that are outstanding as of the effective date shall be recognized as
the requisite service is rendered on or after the effective date. The
compensation cost for that portion of awards shall be based on the grant-date
fair value of those awards as calculated from the pro forma disclosures. Common
stock purchased pursuant to our employee stock purchase plan will be expensed
based upon the fair market value in excess of purchase price.
Intangible
Assets:
Purchase
accounting requires extensive use of accounting estimates and judgments to
allocate the purchase price to the fair market value of the assets purchased and
liabilities assumed. We have accounted for our acquisitions using the purchase
method of accounting. Values were assigned to intangible assets based on
third-party independent valuations, as well as management’s forecasts and
projections that include assumptions related to future revenue and cash flows
generated from the acquired assets. We determined that due to the sale of
substantially all of the Alan James Group business and assets prior to the
opening of business on July 1, 2009, $3,251,838 of intangible assets became
permanently impaired and were expensed.
During
the annual fiscal year end close process, we evaluate our intangible assets for
impairment. We first must investigate if there was a triggering event that would
cause us to evaluate the value of the intangible assets as outlined in the
accounting standard for intangible assets. We determined that there was a
triggering event during the fiscal year 2009, relating to the $0.9 million of
intangible assets related to capitalized patent costs. The triggering event was
the result of a current period operating loss as well as our history of
operating losses. We performed the step one evaluation of undiscounted cash flow
which resulted in $1.5 million of free cash flow which is greater than the
carrying value of $0.7 million therefore no impairment write-down was
required.
Income
taxes:
The
preparation of our consolidated financial statements requires us to estimate our
income taxes in each of the jurisdictions in which we operate, including those
outside the United States, which may be subject to certain risks that ordinarily
would not be expected in the United States. We account for income taxes in
accordance with FASB ASC 740,
Income Taxes
, which requires the recognition of taxes payable or
refundable for the current year and deferred tax liabilities and assets for the
future tax consequences of events that have been recognized in the financial
statements or tax returns. The measurement of current and deferred tax
liabilities and assets is based on provisions of the enacted tax law; the
effects of future changes in tax laws or rates are not anticipated. We record a
valuation allowance to reduce our deferred tax assets to the amount that is more
likely than not to be realized.
Significant
management judgment is required in determining our provision for income taxes,
our deferred tax assets and liabilities and any valuation allowance recorded
against deferred tax assets. We have recorded a full valuation allowance against
our deferred tax assets of $26.3 million as of December 31, 2009, due to
uncertainties related to our ability to utilize these assets. The valuation
allowance is based on management’s estimates of taxable income by jurisdiction
in which we operate and the period over which the deferred tax assets will be
recoverable. In the event that actual results differ from these estimates or
management adjusts these estimates in future periods, we may need to adjust our
valuation allowance, which could materially impact our financial position and
results of operations.
Due to
recent changes in Massachusetts corporate income tax regulations, we will be
filing on a combined basis with Alticor affiliated entities on a go-forward
basis and, as a result, our net operating losses will be fully utilized at
December 31, 2009. The combined filing will have no impact on our financial
statements due to the full valuation allowance that offsets any deferred tax
assets.
Due to
the sale of the majority of the assets of Interleukin Brands Inc. and the
subsequent dissolution of Interleukin Brands Inc. during the year ended December
31, 2009, a full valuation allowance was recorded for the net operating loss
experienced in 2009 and for other deferred tax assets for state income tax
purposes.
We review
our recognition threshold and measurement process for recording in the financial
statements uncertain tax positions taken or expected to be taken in a tax
return. We review all material tax positions for all years open to statute to
determine whether it is more likely than not that the positions taken would be
sustained based on the technical merits of those positions. We did not recognize
any adjustments for uncertain tax positions during the twelve months ended
December 31, 2009.
Contingencies:
Estimated
losses from contingencies are accrued by management based upon the likelihood of
a loss and the ability to reasonably estimate the amount of the loss. Estimating
potential losses, or even a range of losses, is difficult and involves a great
deal of judgment. Management relies primarily on assessments made by its
external legal counsel to make our determination as to whether a loss
contingency arising from litigation should be recorded or disclosed. Should the
resolution of a contingency result in a loss that we did not accrue because
management did not believe a loss was probable or capable of being reasonably
estimated, then this loss would result in a charge to income in the period the
contingency was resolved.
Recent
Accounting Pronouncements:
Please
see our discussion of “recent accounting pronouncements” in Note 4, significant
accounting policies contained in the Notes to Consolidated Financial Statements
elsewhere in this Annual Report on Form 10K.
Item 7A.
Quantitative and Qualitative
Disclosure about Market Risk
As of
December 31, 2009 the only financial instruments we carried were cash and cash
equivalents denominated in U.S. Dollars. We believe the market risk arising from
holding these financial instruments is not material. While we recognize that the
interest rates these instruments bear are currently at historically low levels,
we believe it is most prudent to maintain these relatively low risk positions
during this time of unprecedented volatility and uncertainty across the global
financial markets.
Some of
our sales and some of our costs occur outside the United States and are
transacted in foreign currencies. Accordingly, we may be subject to exposure
from adverse movements in foreign currency exchange rates. At this time we do
not believe this risk is material and we do not currently use derivative
financial instruments to manage foreign currency fluctuation risk. However, if
foreign sales increase and the risk of foreign currency exchange rate
fluctuation increases, we may in the future consider utilizing derivative
instruments to mitigate these risks.
Item 8.
Financial Statements and
Supplementary Data
INTERLEUKIN
GENETICS, INC.
INDEX
TO FINANCIAL STATEMENTS
Report
of Independent Registered Public Accounting Firm
|
36
|
Balance
Sheets
|
37
|
Statements
of Operations
|
38
|
Statements
of Stockholders’ (Deficit) Equity
|
39
|
Statements
of Cash Flows
|
40
|
Notes
to Financial Statements
|
42
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of Directors and
Shareholders
of Interleukin Genetics, Inc.
We
have audited the accompanying balance sheets of Interleukin Genetics, Inc. (a
Delaware corporation) (the “Company”) as of December 31, 2009 and 2008, and the
related statements of operations, stockholders’ (deficit) equity, and cash flows
for each of the three years in the period ended December 31, 2009. 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). Those standards require that we plan
and perform the audit 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 also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, 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 Interleukin Genetics, Inc. as of
December 31, 2009 and 2008, and the results of their operations and their cash
flows for the each of the three years in the period ended December 31, 2009, in
conformity with accounting principles generally accepted in the United States of
America.
/s/
Grant Thornton LLP
Boston,
Massachusetts
March
25, 2010
INTERLEUKIN
GENETICS, INC.
BALANCE
SHEETS
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
(As
Adjusted)
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
906,248
|
|
|
$
|
4,952,481
|
|
Accounts
receivable from related party
|
|
|
24,594
|
|
|
|
35,167
|
|
Trade
accounts receivable
|
|
|
9,285
|
|
|
|
8,219
|
|
Inventory
|
|
|
118,430
|
|
|
|
—
|
|
Prepaid
expenses and other current assets
|
|
|
225,493
|
|
|
|
162,834
|
|
Current
assets of discontinued operations
|
|
|
31,941
|
|
|
|
1,707,583
|
|
Total
current assets
|
|
|
1,315,991
|
|
|
|
6,866,284
|
|
Fixed
assets, net
|
|
|
769,981
|
|
|
|
435,480
|
|
Intangible
assets, net
|
|
|
745,490
|
|
|
|
889,941
|
|
Other
assets
|
|
|
238,001
|
|
|
|
38,001
|
|
Other
assets of discontinued operations
|
|
|
—
|
|
|
|
3,924,682
|
|
Total
assets
|
|
$
|
3,069,463
|
|
|
$
|
12,154,388
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
321,444
|
|
|
$
|
884,421
|
|
Accrued
expenses
|
|
|
281,806
|
|
|
|
197,023
|
|
Deferred
revenue
|
|
|
107,792
|
|
|
|
403,475
|
|
Accrued
expenses related to funded research and development
projects
|
|
|
—
|
|
|
|
22,056
|
|
Liabilities
of discontinued operations
|
|
|
1,123,049
|
|
|
|
2,159,986
|
|
Total
current liabilities
|
|
|
1,834,091
|
|
|
|
3,666,961
|
|
Convertible
long term debt
|
|
|
7,000,000
|
|
|
|
4,000,000
|
|
Deferred
tax liability of discontinued operations
|
|
|
—
|
|
|
|
5,000
|
|
Total
liabilities
|
|
|
8,834,091
|
|
|
|
7,671,961
|
|
Stockholders’
(deficit) equity:
|
|
|
|
|
|
|
|
|
Convertible
preferred stock, $0.001 par value — 6,000,000 shares authorized; 5,000,000
shares of Series A issued and outstanding at December 31, 2009 and
December 31, 2008; aggregate liquidation preference of $18,000,000 at
December 31, 2009
|
|
|
5,000
|
|
|
|
5,000
|
|
Common
stock, $0.001 par value — 100,000,000 shares authorized; 32,102,435 and
31,799,381 shares issued and outstanding at December 31, 2009 and December
31, 2008, respectively
|
|
|
32,102
|
|
|
|
31,799
|
|
Additional
paid-in capital
|
|
|
85,763,379
|
|
|
|
85,458,334
|
|
Accumulated
deficit
|
|
|
(91,565,109
|
)
|
|
|
(81,012,706
|
)
|
Total
stockholders’ (deficit) equity
|
|
|
(5,764,628
|
)
|
|
|
4,482,427
|
|
Total
liabilities and stockholders’ equity
|
|
$
|
3,069,463
|
|
|
$
|
12,154,388
|
|
The
accompanying notes are an integral part of these financial
statements.
INTERLEUKIN
GENETICS, INC.
STATEMENTS
OF OPERATIONS
|
|
Year Ended December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
(As Adjusted)
|
|
|
(As Adjusted)
|
|
Continuing Operations
|
|
|
|
|
|
|
|
|
|
Total
revenue
|
|
$
|
1,078,430
|
|
|
$
|
2,620,687
|
|
|
$
|
2,827,284
|
|
Cost
of revenue
|
|
|
1,203,647
|
|
|
|
940,241
|
|
|
|
975,770
|
|
Gross
profit (loss)
|
|
|
(125,217
|
)
|
|
|
1,680,446
|
|
|
|
1,851,514
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
& development
|
|
|
3,213,115
|
|
|
|
3,560,002
|
|
|
|
2,928,249
|
|
Selling,
general & administrative
|
|
|
5,575,911
|
|
|
|
5,012,345
|
|
|
|
3,970,869
|
|
Amortization
of intangibles
|
|
|
115,453
|
|
|
|
100,693
|
|
|
|
73,223
|
|
Total
operating expenses
|
|
|
8,904,479
|
|
|
|
8,673,040
|
|
|
|
6,972,341
|
|
Loss
from continuing operations
|
|
|
(9,029,696
|
)
|
|
|
(6,992,594
|
)
|
|
|
(5,120,827
|
)
|
Other
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
|
10,183
|
|
|
|
158,773
|
|
|
|
414,493
|
|
Interest
Expense
|
|
|
(158,760
|
)
|
|
|
(130,253
|
)
|
|
|
(231,992
|
)
|
Other
expense:
|
|
|
—
|
|
|
|
—
|
|
|
|
(456,223
|
)
|
Total
other income (expense)
|
|
|
(148,577
|
)
|
|
|
28,520
|
|
|
|
(273,722
|
)
|
Net
loss from continuing operations before income taxes
|
|
|
(9,178,273
|
)
|
|
|
(6,964,074
|
)
|
|
|
(5,394,549
|
)
|
Provision
(benefit) for income taxes
|
|
|
—
|
|
|
|
31,000
|
|
|
|
(31,000
|
)
|
Net
loss from continuing operations
|
|
|
(9,178,273
|
)
|
|
|
(6,933,074
|
)
|
|
|
(5,425,549
|
)
|
Discontinued
Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) from discontinued operations, net of income
taxes
|
|
|
(27,928
|
)
|
|
|
281,689
|
|
|
|
(793,236
|
)
|
Loss
on sale of discontinued operations including impairment charge of
$3,251,838 in 2009
|
|
|
(1,346,202
|
)
|
|
|
—
|
|
|
|
—
|
|
Net
income (loss) from discontinued operations, net of tax
|
|
|
(1,374,130
|
)
|
|
|
281,689
|
|
|
|
(793,236
|
)
|
Net
loss
|
|
$
|
(10,552,403
|
)
|
|
$
|
(6,651,385
|
)
|
|
$
|
(6,218,785
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net income (loss) per common share from:
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(0.29
|
)
|
|
$
|
(0.22
|
)
|
|
$
|
(0.20
|
)
|
Discontinued
operations
|
|
|
(0.04
|
)
|
|
|
0.01
|
|
|
|
(0.02
|
)
|
Net
loss
|
|
|
(0.33
|
)
|
|
|
(0.21
|
)
|
|
|
(0.22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
|
|
32,007,826
|
|
|
|
31,354,198
|
|
|
|
27,723,754
|
|
The accompanying notes are an integral
part of these financial statements.
INTERLEUKIN
GENETICS, INC.
STATEMENTS
OF STOCKHOLDERS’ (DEFICIT) EQUITY
For
the Years Ended December 31, 2009, 2008 and 2007
|
|
Convertible Preferred
Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
Paid-in
Capital
|
|
|
|
|
|
|
|
Balance
as of December 31,
2006
|
|
|
5,000,000
|
|
|
$
|
5,000
|
|
|
|
27,406,984
|
|
|
$
|
27,407
|
|
|
$
|
81,896,060
|
|
|
$
|
(68,142,536
|
)
|
|
$
|
13,785,931
|
|
Net
loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(6,218,785
|
)
|
|
|
(6,218,785
|
)
|
Common
stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
of stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
194,917
|
|
|
|
195
|
|
|
|
347,217
|
|
|
|
—
|
|
|
|
347,412
|
|
Employee
stock purchase plan
|
|
|
—
|
|
|
|
—
|
|
|
|
7,702
|
|
|
|
8
|
|
|
|
16,713
|
|
|
|
—
|
|
|
|
16,721
|
|
Restricted
stock awards
|
|
|
—
|
|
|
|
—
|
|
|
|
12,500
|
|
|
|
12
|
|
|
|
(12
|
)
|
|
|
—
|
|
|
|
—
|
|
Common
stock awards
|
|
|
—
|
|
|
|
—
|
|
|
|
7,000
|
|
|
|
7
|
|
|
|
(7
|
)
|
|
|
—
|
|
|
|
—
|
|
Conversion
of long-term debt to equity
|
|
|
—
|
|
|
|
—
|
|
|
|
3,190,987
|
|
|
|
3,191
|
|
|
|
2,032,098
|
|
|
|
—
|
|
|
|
2,035,289
|
|
Rights
offering, net of issuance costs
|
|
|
—
|
|
|
|
—
|
|
|
|
12,012
|
|
|
|
12
|
|
|
|
52,670
|
|
|
|
—
|
|
|
|
52,682
|
|
Stock-based
compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
173,164
|
|
|
|
—
|
|
|
|
173,164
|
|
Balance
as of December 31, 2007
|
|
|
5,000,000
|
|
|
$
|
5,000
|
|
|
|
30,832,102
|
|
|
$
|
30,832
|
|
|
$
|
84,517,903
|
|
|
$
|
(74,361,321
|
)
|
|
$
|
10,192,414
|
|
Net
loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(6,651,385
|
)
|
|
|
(6,651,385
|
)
|
Investment
by Alticor (note 5)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
168,254
|
|
|
|
—
|
|
|
|
168,254
|
|
Common
stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
stock purchase plan
|
|
|
—
|
|
|
|
—
|
|
|
|
11,747
|
|
|
|
12
|
|
|
|
10,223
|
|
|
|
—
|
|
|
|
10,235
|
|
Restricted
stock awards
|
|
|
—
|
|
|
|
—
|
|
|
|
12,500
|
|
|
|
12
|
|
|
|
(12
|
)
|
|
|
—
|
|
|
|
—
|
|
Conversion
of long-term debt to equity
|
|
|
—
|
|
|
|
—
|
|
|
|
943,032
|
|
|
|
943
|
|
|
|
601,843
|
|
|
|
—
|
|
|
|
602,786
|
|
Stock-based
compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
160,123
|
|
|
|
—
|
|
|
|
160,123
|
|
Balance
as of December 31, 2008
|
|
|
5,000,000
|
|
|
$
|
5,000
|
|
|
|
31,799,381
|
|
|
$
|
31,799
|
|
|
$
|
85,458,334
|
|
|
$
|
(81,012,706
|
)
|
|
$
|
4,482,427
|
|
Net
loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(10,552,403
|
)
|
|
|
(10,552,403
|
)
|
Common
stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
stock purchase
|
|
|
—
|
|
|
|
—
|
|
|
|
126,500
|
|
|
|
127
|
|
|
|
34,028
|
|
|
|
—
|
|
|
|
34,155
|
|
Exercise
of employee stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
15,000
|
|
|
|
15
|
|
|
|
3,885
|
|
|
|
—
|
|
|
|
3,900
|
|
Employee
stock purchase plan
|
|
|
—
|
|
|
|
—
|
|
|
|
149,054
|
|
|
|
149
|
|
|
|
34,455
|
|
|
|
—
|
|
|
|
34,604
|
|
Restricted
stock awards
|
|
|
—
|
|
|
|
—
|
|
|
|
12,500
|
|
|
|
12
|
|
|
|
(12
|
)
|
|
|
—
|
|
|
|
—
|
|
Stock-based
compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
232,689
|
|
|
|
—
|
|
|
|
232,689
|
|
Balance
as of December 31, 2009
|
|
|
5,000,000
|
|
|
$
|
5,000
|
|
|
|
32,102,435
|
|
|
$
|
32,102
|
|
|
$
|
85,763,379
|
|
|
$
|
(91,565,109
|
)
|
|
$
|
(5,764,628
|
)
|
The accompanying notes are an integral
part of these financial statements.
INTERLEUKIN
GENETICS, INC.
STATEMENTS
OF CASH FLOWS
|
|
For the Year Ended December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
(As Adjusted)
|
|
|
(As Adjusted)
|
|
CASH FLOW FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(10,552,403
|
)
|
|
$
|
(6,651,385
|
)
|
|
$
|
(6,218,785
|
)
|
Loss
on sale of discontinued operations
|
|
|
1,346,202
|
|
|
|
—
|
|
|
|
—
|
|
Net
income (loss) from discontinued operations
|
|
|
27,928
|
|
|
|
(281,689
|
)
|
|
|
793,237
|
|
Net
loss from continuing operations
|
|
|
(9,178,273
|
)
|
|
|
(6,933,074
|
)
|
|
|
(5,425,548
|
)
|
Adjustments
to reconcile net loss to net cash used in
|
|
|
|
|
|
|
|
|
|
|
|
|
operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
& Amortization
|
|
|
494,956
|
|
|
|
379,310
|
|
|
|
365,036
|
|
Amortization
of note discount
|
|
|
—
|
|
|
|
—
|
|
|
|
457,484
|
|
Stock
and other non-cash Compensation Expense
|
|
|
193,912
|
|
|
|
153,287
|
|
|
|
173,166
|
|
Interest
capitalized in debt to equity conversion
|
|
|
—
|
|
|
|
—
|
|
|
|
39,679
|
|
Loss
on disposal of fixed assets
|
|
|
—
|
|
|
|
—
|
|
|
|
3,239
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Account
receivable, net
|
|
|
9,507
|
|
|
|
4,848
|
|
|
|
152,406
|
|
Inventory
|
|
|
(118,430
|
)
|
|
|
—
|
|
|
|
—
|
|
Prepaid
expenses and other current assets
|
|
|
(62,659
|
)
|
|
|
50,150
|
|
|
|
29,774
|
|
Accounts
payable
|
|
|
(562,977
|
)
|
|
|
508,190
|
|
|
|
(136,336
|
)
|
Accrued
expenses
|
|
|
84,783
|
|
|
|
(544,616
|
)
|
|
|
328,874
|
|
Deferred
revenue
|
|
|
(295,683
|
)
|
|
|
(793,399
|
)
|
|
|
147,945
|
|
Commitments
for funded R&D
|
|
|
(22,056
|
)
|
|
|
(70,000
|
)
|
|
|
(73,500
|
)
|
Deferred
tax provision
|
|
|
—
|
|
|
|
(31,000
|
)
|
|
|
31,000
|
|
Net
cash provided by operating activities of discontinued
operations
|
|
|
2,908,588
|
|
|
|
1,710,550
|
|
|
|
1,368,132
|
|
Net
cash used in operating activities
|
|
|
(6,548,332
|
)
|
|
|
(5,565,754
|
)
|
|
|
(2,538,649
|
)
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases
of fixed assets
|
|
|
(714,003
|
)
|
|
|
(192,728
|
)
|
|
|
(35,449
|
)
|
Increase
in other assets
|
|
|
—
|
|
|
|
—
|
|
|
|
(196,209
|
)
|
Decrease
(Increase) in intangibles
|
|
|
28,998
|
|
|
|
(353,190
|
)
|
|
|
—
|
|
Acquisition
of Alan James Group, LLC
|
|
|
—
|
|
|
|
(600,000
|
)
|
|
|
—
|
|
Net
cash provided (used) in investing activities of discontinued
operations
|
|
|
114,445
|
|
|
|
—
|
|
|
|
(82,959
|
)
|
Net
cash used in investing activities
|
|
|
(570,560
|
)
|
|
|
(1,145,918
|
)
|
|
|
(314,617
|
)
|
CASH
FLOW FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from issuance of common stock
|
|
|
34,155
|
|
|
|
602,786
|
|
|
|
—
|
|
Proceeds
from issuance of bridge loans and notes payable
|
|
|
3,000,000
|
|
|
|
4,000,000
|
|
|
|
—
|
|
Repayments
of bridge loans and notes payable
|
|
|
—
|
|
|
|
(595,336
|
)
|
|
|
—
|
|
Proceeds
from exercises of warrants and employee stock options
|
|
|
3,900
|
|
|
|
—
|
|
|
|
347,412
|
|
Proceeds
from employee stock purchase plan
|
|
|
34,604
|
|
|
|
10,235
|
|
|
|
16,721
|
|
Proceeds
from rights offering
|
|
|
—
|
|
|
|
—
|
|
|
|
52,682
|
|
Net
cash provided by financing activities
|
|
|
3,072,659
|
|
|
|
4,017,685
|
|
|
|
416,815
|
|
Net
decrease in cash and equivalents
|
|
|
(4,046,233
|
)
|
|
|
(2,693,987
|
)
|
|
|
(2,436,451
|
)
|
Cash
and cash equivalents, beginning of period
|
|
|
4,952,481
|
|
|
|
7,646,468
|
|
|
|
10,082,919
|
|
Cash
and cash equivalents, end of period
|
|
$
|
906,248
|
|
|
$
|
4,952,481
|
|
|
$
|
7,646,468
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for income taxes
|
|
$
|
41,941
|
|
|
$
|
26,102
|
|
|
$
|
—
|
|
Cash
paid for interest
|
|
$
|
158,774
|
|
|
$
|
72,016
|
|
|
$
|
197,628
|
|
Non-cash
activities:
On
February 25, 2008, the Company recognized $168,254 of funds previously received
from Alticor under a research agreement for which no work has been performed,
and no work will be required to be performed as additional paid-in capital on
the Company’s balance sheet. The amount previously received of $168,254 was
initially recorded as deferred revenue.
On
June 11, 2008, the Company converted the indebtedness due on June 30,
2008, representing an aggregate principal amount of $595,336 and accrued
interest of $7,450, into 943,032 shares of the Company’s common
stock.
The
accompanying notes are an integral part of these financial
statements.
INTERLEUKIN
GENETICS, INC.
NOTES
TO FINANCIAL STATEMENTS
Note 1—Company
Overview
Interleukin
Genetics, Inc. and subsidiaries (Interleukin or the Company) is a company
focused on developing, acquiring, and commercializing personalized health
products that can help individuals improve and maintain their health through
preventive measures. It uses functional genomics to help in the development of
risk assessment tests based on the genetic variations in people. Interleukin has
commercialized genetic tests for periodontal disease risk assessment,
cardiovascular risk assessment, general nutrition assessment, weight management
and bone health. In addition, through its Alan James Group subsidiary which it
acquired in August 2006 and divested in June 2009. Interleukin sold its
nutritional product brands, including Ginsana
®
,
Ginkoba
™
, and
Venastat
®
, through
the nation’s largest food, drug and mass retailers. The Company’s current
development programs focus on commercializing its weight management and
periodontal genetic risk assessment tests.
The
Company was incorporated in Texas in 1986 and re-incorporated in Delaware in
March 2000.
The
Company has experienced losses since its inception through December 31,
2009. During the last three years such losses totaled $23.4 million contributing
to an accumulated deficit of $91.6 million as of December 31, 2009. Based
on the current operating and capital expenditure forecasts, the Company believes
that the combination of funds currently available, funds to be generated from
operations and the available lines of credit will be adequate to finance their
ongoing operations for at least the next twelve months.
Note 2—Operating
Matters and Liquidity
The
Company has experienced net operating losses since its inception through
December 31, 2009. During the last three fiscal years such losses totaled $23.4
million contributing to an accumulated deficit of $91.6 million as of December
31, 2009. During this same period, the Company has increased its borrowings by
$7.0 million under its line of credit with Pyxis. On February 1, 2010 the
Company borrowed an additional $2.0 million. The Company has access to $5.3
million of available borrowings through June 30, 2011.
Throughout
2009, the Company took steps to control expenses and further enhance its
liquidity and cash flow. Prior to the opening of business on July 1, 2009 the
Company sold substantially all of the Alan James Group business of its
subsidiary AJG Brands, Inc. for $4.6 million consisting of $4.4 million in cash
and a $0.2 million holdback. The Company decided to sell these non core assets
as a way to concentrate on its genetic test business. The Company will no longer
have the positive cash flow of this business but will have lower administration
and operating costs as a result of the focus on the genetic test business. The
cash received from the sale resulted in less borrowings being needed in 2009.
The Company took steps in 2009 to further reduce operating costs such as
consulting and research expenses to focus on our product development efforts. We
continue our efforts to sublease unused office space to further offset operating
costs.
In
addition to the steps taken in 2009, on March 5, 2010, the Company entered into
a definitive agreement with certain institutional investors to sell $5.3 million
of securities in a registered direct offering. Net proceeds of approximately
$4.9 million were received on March 10, 2010.
We expect
that our current and anticipated financial resources, including the amount
available under our credit facility with Pyxis and the $4.9 million in net
proceeds we received from the security offering in March 2010 are adequate to
maintain our current and planned operations for the next 18 months.
Note 3—Discontinued
Operations
In August
2006, the Company acquired the assets and business of the Alan James
Group, LLC (the Alan James Group). The acquired business primarily
developed, marketed and sold nutritional products and engaged in related
activities. The Alan James Group was a provider of products and services in the
consumer healthcare marketplace. The initial purchase price consisted of the
payment of $7,031,257 in cash and the obligation to place in escrow $250,000 and
88,055 shares of the Company’s Common Stock valued at $500,000, or $5.6873 per
share (based on the volume-weighted average closing stock price for the 20
consecutive trading days ending August 15, 2006). The $250,000 and 88,055
common stock shares that were to have been placed in escrow was settled as part
of the agreement dated March 25, 2008. The acquisition was accounted for as
a purchase in accordance with Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) 805,
Business
Combinations
.
The
purchase price was allocated to the tangible and intangible assets acquired and
liabilities assumed based on their estimated fair values at the date of
acquisition. The estimated fair value of the assets acquired and liabilities
assumed exceeded the initial payments by approximately $2.2 million
resulting in negative goodwill. The Company recorded as a liability, contingent
consideration up to the amount of negative goodwill.
On
March 25, 2008, pursuant to the terms of a settlement agreement between the
Company and former owners of the Alan James Group regarding the acquisition of
its assets and business, the Company agreed to pay a total of $1,200,000. This
agreement resolved all remaining issues associated with the Company’s August
2006 acquisition of that business including contingent consideration and
compensation arrangements with the seller/former management. The $1,200,000 due
to sellers was recorded as a current liability at December 31, 2007. The
Company applied $600,000 of the settlement cost against the previously accrued
separation expense that was recorded on June 30, 2007 and the remaining
$600,000 was applied against the $2,130,374 aggregate total of contingent
liabilities and amounts due under escrow recorded as part of the original
acquisition. The remaining contingent liabilities and amounts due under escrow
balance of $1,530,374 was eliminated as no longer due and applied as a reduction
in the balances on a pro rata basis of the intangible assets recorded as part of
the original acquisition, including the effect of term reduction on the
non-compete agreements.
Prior to
the opening of business on July 1, 2009, the Company and its wholly-owned
subsidiary, AJG Brands, Inc. entered into an asset purchase agreement with
Nutraceutical Corporation and Pep Products, Inc., a wholly-owned subsidiary of
Nutraceutical Corporation, pursuant to which substantially all of the Alan James
Group business and assets of AJG Brands, Inc. were sold to Pep Products, Inc.
for an aggregate sale price of $4,572,292. The proceeds consist of a $200,000
holdback reflected in other assets and $4,372,292 received on July 1, 2009. The
assets sold consisted primarily of accounts receivable, inventories, property
and equipment and other assets related to the business, which primarily
develops, markets and sells nutritional supplements and related products into
retail consumer channels. The buyer did not assume accounts payable and accrued
liabilities. Subsequent to the closing, AJG Brands, Inc.’s name was changed to
Interleukin Brands, Inc. (“IBI”). The assets remaining in IBI consist primarily
of certain remaining accounts receivable and inventory. All remaining accounts
receivable and inventory has been fully reserved for. Liabilities of
discontinued operations primarily consist of accruals for inventory in the
retail channel with the right of return.
The Company recognized a loss on the
sale of discontinued operations of $1,346,202. This includes a gain on the sale
of net tangible assets of $2,579,879, direct costs of the disposition of
$674,243 and a loss from the permanent impairment of all remaining AJG Brands,
Inc.’s intangible assets in the amount of $3,251,838.
AJG Brands, Inc.’s sales reported in
discontinued operations for the twelve months ended December 31, 2009 were
$3,580,169 and for the three months and twelve months ended December 31, 2008
were $1,801,026 and 7,394,293, respectively.
The following is a summary of the net
assets sold at the close of business on June 30, 2009.
Accounts
receivable
|
|
$
|
1,114,835
|
|
Inventories
|
|
|
783,512
|
|
Property
and equipment, net.
|
|
|
21,073
|
|
Other
assets
|
|
|
72,993
|
|
Net
tangible assets sold from discontinued operations
|
|
$
|
1,992,413
|
|
Note 4—Significant
Accounting Policies
Prior to
December 29, 2009 the consolidated financial statements included the accounts of
Interleukin Genetics, Inc., and its wholly-owned subsidiaries, Interleukin
Genetics Laboratory Services, Inc. and Interleukin Brands, Inc., formerly
AJG Brands, Inc. doing business as the Alan James Group. On December 29,
2009 the two wholly-owned subsidiaries were merged into Interleukin Genetics,
Inc. and the consolidated financial statements remained unchanged with this
transaction. All intercompany accounts and transactions have been eliminated. In
comparative periods the Company has separately disclosed the operating portion
of cash flows attributable to discontinued operations, which in prior periods
were reported on a combined basis as a single amount.
Management
Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosures of contingent assets and liabilities at the date of
the financial statements, as well as the reported amounts of revenue and
expenses during the reported periods. Actual results could differ from those
estimates. The Company’s most critical accounting policies are in areas of its
strategic alliance with Alticor (see Note 5), revenue recognition, allowance for
sales returns, trade promotions, accounts receivable, inventory, stock-based
compensation, income taxes, and long-lived assets. These critical accounting
policies are more fully discussed in these notes to the consolidated financial
statements.
Revenue
Recognition
Revenue
from genetic testing services is recognized when there is persuasive evidence of
an arrangement, service has been rendered, the sales price is determinable and
collectability is reasonably assured. Service is deemed to be rendered when the
results have been reported to the individual who ordered the test. To the extent
that tests have been prepaid but results have not yet been reported, recognition
of all related revenue is deferred. As of December 31, 2009 and 2008, the
Company has deferred receipts of $107,792 and $80,000, respectively, for tests
that have been prepaid but results have not yet been reported.
Revenue
from product sales is recognized when there is persuasive evidence of an
arrangement, delivery has occurred and title and risk of loss have transferred
to the customer, the sales price is determinable and collectability is
reasonably assured. The Company has no consignment sales. Product revenue is
reduced for allowances and adjustments, including returns, discontinued items,
discounts, trade promotions and slotting fees.
Revenue
from contract research and development is recognized over the term of the
contract as the Company performs its obligations under that contract (including
revenue from Alticor, a related party).
Allowance
for Sales Return
We
analyze sales returns in accordance with the provisions of FASB ASC 605,
Revenue Recognition.
We are
able to make reasonable and reliable estimates based on the buying patterns of
the end-users of its products based on sales data received. We believe we have
sufficient interaction with and knowledge of our customers, industry trends and
industry conditions to adjust the accrual for returns when
necessary.
At
December 31, 2009, we have fully reserved for any potential sales returns and
discontinued items of $1.0 million applicable to the non-acquired accounts
resulting from our sale of substantially all of the assets of the Alan James
Group business. During 2009 payments of approximately $0.3 million were made
directly to product returns from non-acquired accounts.
Trade
Promotions
Pursuant
to the asset purchase agreement in connection with the Company’s sale of
substantially all of the Alan James Group business and assets, the Company fully
accrued for the approximately $150,000 of agreed upon trade promotions
implemented prior to June 30, 2009. At December 31, 2009 the balance of trade
promotions estimated to be due in the future was $70,859.
Accounts
Receivable
Pursuant
to the asset purchase agreement in connection with the Company’s sale of
substantially all of the Alan James Group business and assets, the Company
retained non acquired accounts receivable in the amount of $180,605 which was
fully reserved for as uncollectible at June 30, 2009. At December 31, 2009, the
balance in such non acquired accounts approximated $107,000 which is deemed
uncollectable and has been fully reserved for. Prior to the acquisition trade
accounts receivable were stated at estimated net realizable value, which is
generally the invoiced amount less any estimated discount related to payment
terms. The Company offered its Consumer Product customers a 2% cash discount if
payment was made within 30 days of the invoice date, however, most
customers took the discount regardless of when payment occurred.
Inventory
Inventory
on hand at December 31, 2009 consists of product genetic test kits related to
our Inherent Health
®
brand of
genetic tests. Inventory is stated at the lower of cost or market. No overhead
or administrative costs are included in inventory. No inventory reserve is
required at December 31, 2009 as all test kits are available for sale and
management has determined will be sold. When a kit is sold the corresponding
cost of the kit is recorded as cost of goods sold and removed from
inventory.
As part
of the Company’s subsequent sale of substantially all of the Alan James Group
business and assets all non acquired inventory amounting to approximately
$129,000 was scrapped and written off in the fourth quarter of
2009.
Inventory
consisted of the following at December 31, 2009 and December 31,
2008:
|
|
|
|
|
|
|
Continuing
Operations
|
|
|
|
|
|
|
Raw
materials
|
|
$
|
103,479
|
|
|
$
|
—
|
|
Finished
goods
|
|
|
14,951
|
|
|
|
—
|
|
Total
inventory, net
|
|
$
|
118,430
|
|
|
$
|
—
|
|
Stock-Based
Compensation
The
Company accounts for stock-based compensation expense in accordance with FASB
ASC 718,
Compensation – Stock
Compensation
. The standard addresses all forms of share-based payment
(SBP) awards, including shares issued under employee stock purchase plans, stock
options, restricted stock and stock appreciation rights. We expense SBP awards
with compensation cost for SBP transactions measured at fair value. Compensation
cost for the portion of awards for which the requisite service has not been
rendered that are outstanding as of the effective date shall be recognized as
the requisite service is rendered on or after the effective date. The
compensation cost for that portion of awards shall be based on the grant-date
fair value of those awards as calculated from the pro forma disclosures. Common
stock purchased pursuant to our employee stock purchase plan will be expensed
based upon the fair market value in excess of purchase price.
Income
Taxes
The
preparation of its consolidated financial statements requires the Company to
estimate its income taxes in each of the jurisdictions in which it operates,
including those outside the United States, which may be subject to certain risks
that ordinarily would not be expected in the United States. The Company accounts
for income taxes in accordance with FASB ASC 740,
Income Taxes
, which requires
the recognition of taxes payable or refundable for the current year and deferred
tax liabilities and assets for the future tax consequences of events that have
been recognized in the financial statements or tax returns. The measurement of
current and deferred tax liabilities and assets is based on provisions of the
enacted tax law; the effects of future changes in tax laws or rates are not
anticipated. The Company records a valuation allowance to reduce its deferred
tax assets to the amount that is more likely than not to be
realized.
Significant
management judgment is required in determining the Company’s provision for
income taxes, its deferred tax assets and liabilities and any valuation
allowance recorded against deferred tax assets. The Company has recorded a full
valuation allowance against its deferred tax assets of $26.3 million as of
December 31, 2009, due to uncertainties related to its ability to utilize these
assets. The valuation allowance is based on management’s estimates of taxable
income by jurisdiction in which the Company operates and the period over which
the deferred tax assets will be recoverable. In the event that actual results
differ from these estimates or management adjusts these estimates in future
periods, the Company may need to adjust its valuation allowance, which could
materially impact its financial position and results of operations.
Due to
recent changes in Massachusetts corporate income tax regulations, the Company
will file a combined tax return with Alticor affiliated entities and as a
result, the Company’s net operating losses will be fully utilized at December
31, 2009. The combined filing will have no impact on the Company's financial
statements due to the full valuation allowance that offsets any deferred tax
assets.
Due to
the sale of the majority of the assets of Interleukin Brands Inc. and the
subsequent dissolution of Interleukin Brands Inc. during the year ended December
31, 2009, a full valuation allowance was recorded for the net operating loss
experienced in 2009 and for other deferred tax assets for state income tax
purposes.
The
Company reviews its recognition threshold and measurement process for recording
in the financial statements uncertain tax positions taken or expected to be
taken in a tax return. The Company reviews all material tax positions for all
years open to statute to determine whether it is more likely than not that the
positions taken would be sustained based on the technical merits of those
positions. The Company did not recognize any adjustments for uncertain tax
positions during the twelve months ended December 31, 2009.
Research
and Development
Research
and development costs are expensed as incurred.
Advertising
Expense
Advertising
costs are expensed as incurred. During the years ended December 31, 2009, 2008
and 2007 advertising expense was $892,000, $516,000, and $26,000,
respectively.
Basic
and Diluted Net Loss per Common Share
The
Company applies the provisions of FASB ASC 260,
Earnings per Share
, which
establishes standards for computing and presenting earnings per share. Basic and
diluted net loss per share was determined by dividing net loss applicable to
common stockholders by the weighted average number of shares of common stock
outstanding during the period. Diluted net loss per share is the same as basic
net loss per share for all the periods presented, as the effect of the potential
common stock equivalents is anti-dilutive due to the loss in each period.
Potential common stock equivalents excluded from the calculation of diluted net
loss per share consists of stock options, warrants, convertible preferred stock
and convertible debt as described in the table below:
|
|
|
|
|
|
|
|
|
|
Options
outstanding
|
|
|
1,578,917
|
|
|
|
2,100,917
|
|
|
|
1,366,406
|
|
Warrants
outstanding
|
|
|
400,000
|
|
|
|
400,000
|
|
|
|
400,000
|
|
Convertible
preferred stock
|
|
|
28,160,200
|
|
|
|
28,160,200
|
|
|
|
28,160,200
|
|
Convertible
debt
|
|
|
1,232,763
|
|
|
|
704,436
|
|
|
|
931,377
|
|
Total
|
|
|
31,371,880
|
|
|
|
31,365,553
|
|
|
|
30,857,983
|
|
Comprehensive
Income (Loss)
Comprehensive
income (loss) is defined as the change in equity of a business enterprise during
a period from transactions and other events and circumstances from non-owner
sources. During the years ended December 31, 2009, 2008 and 2007, there
were no items other than net loss included in the comprehensive
loss.
Fair
Value of Financial Instruments
The
Company, using available market information, has determined the estimated fair
values of financial instruments. The stated values of cash and cash equivalents,
long term convertible debt, accounts receivable and accounts payable approximate
fair value due to the nature of these instruments. The carrying amounts of
borrowings under short-term agreements approximate their fair value as the rates
applicable to the financial instruments reflect changes in overall market
interest rates.
Cash
and Cash Equivalents
Cash and
cash equivalents consist of amounts on deposit in checking and savings accounts
with banks and other financial institutions. Cash equivalents include short-term
investments that consist of bank money market funds which have short-term
maturities of less than ninety days. Cash balances could be in excess of FDIC
insurance limits.
Fixed
Assets
Fixed
assets are stated at cost, less accumulated depreciation and amortization.
Depreciation and amortization are provided using the straight-line method over
estimated useful lives of three to five years. Leasehold improvements are
amortized over the estimated useful life of the asset, or the remaining term of
the lease, whichever is shorter.
Long-Lived
Assets
The
Company evaluates its long-lived assets for impairment whenever events or
changes in circumstances indicate that carrying amounts of such assets may not
be recoverable. Recoverability of assets to be held and used is measured by a
comparison of the carrying amount of an asset to the future undiscounted net
cash flows expected to be generated by the asset. Any write-downs, based on fair
value, are to be treated as permanent reductions in the carrying amount of the
assets. The Company determined that no impairment existed related to the
Company’s long-lived assets at December 31, 2009.
Intangible
Assets
The
Company performs impairment tests on an interim basis, if certain conditions
exist, with impaired assets written down to fair value. See Note 3 for
adjustments of intangible assets related to the settlement effective
March 25, 2008. The Company determined that due to the sale of
substantially all of the Alan James Group business and assets of its
wholly-owned subsidiary, AJG Brands, Inc., prior to the opening of business on
July 1, 2009, the remaining $3,251,838 of intangible assets became permanently
impaired and were expensed. Intangible assets as of December 31, 2009 consist of
patents which are evaluated for impairment if certain conditions exist; no such
conditions were identified in 2009.
Recent
Accounting Pronouncements
Effective
January 1, 2009, The Company has applied the provisions of FASB ASC 810,
Consolidation.
The standard
establishes new accounting and reporting standards for noncontrolling interests
in a subsidiary and for the deconsolidation of a subsidiary and required
entities to classify noncontrolling interests as a component of stockholders'
equity as well as require subsequent changes in ownership interest in a
subsidiary to be accounted for as an equity transaction. Additionally, the
standard requires entities to recognize a gain or loss upon the loss of control
of a subsidiary and to remeasure any ownership interest retained at fair value
on that date. This statement requires expanded disclosures that clearly identify
and distinguish between the interests of the parent and the interests of the
noncontrolling owners. The adoption of ASC 810 did not have a material effect on
the Company's financial position or results of operations.
Effective
January 1, 2009, the Company has applied the provisions of FASB ASC 808,
Collaborative Arrangements.
The guidance defines collaborative arrangements and established presentation and
disclosure requirements for transactions within a collaborative arrangement
(both with third parties and between participants in the arrangement) and
required retrospective application to all collaborative arrangements existing as
of the effective date, unless retrospective application was impracticable. The
impracticability evaluation and exception should be performed on an
arrangement-by-arrangement basis. This adoption did not have a significant
effect on the Company’s financial statements.
Effective
June 30, 2009, the Company has applied the provisions of FASB ASC 855,
Subsequent Events,
which
established general standards of accounting for and disclosures of events that
occur after the balance sheet date but before the financial statements are
issued or available to be used. The Company evaluated its December 31, 2009
financial statements for subsequent events through the date the financial
statements are available to be issued. The Company is not aware of any
subsequent events which would require recognition or disclosure in the financial
statements beyond (i) the Employment Agreement dated January 21, 2010 between
the Company and Lewis H. Bender disclosed in Note 12, (ii) the second amendment
dated February 1, 2010 to the Amended And Restated Note Purchase Agreement dated
March 10, 2009, (iii) the $2.0 million borrowing on February 1, 2010 as
disclosed in Note 6 and (iv) the March 5, 2010 sale of common stock and warrants
to certain institutional investors.
Effective
September 30, 2009, the Company has applied the provisions of FASB ASC 105,
The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting
Principles.
The Standard is now the single source of authoritative
nongovernmental U.S. generally accepted accounting principles or GAAP,
superceding existing FASB, American Institute of Certified Public Accountants
(AICPA), EITF, and related accounting literature. The Standard reorganizes the
thousands of GAAP pronouncements into roughly 90 accounting topics and displays
them using a consistent structure. Also included is relevant Securities and
Exchange Commission guidance organized using the same topical structure in
separate sections. The adoption did not have a material impact on the Company’s
financial statements. However, the standard changed the Company’s references to
GAAP in its consolidated financial statements.
Note 5—Strategic
Alliance with Alticor Inc.
Since
March 2003, the Company has maintained a broad strategic alliance with several
affiliates of the Alticor family of companies to develop and market novel
nutritional and skin care products. The alliance initially included an equity
investment, a multi-year research and development agreement, a licensing
agreement with royalties on marketed products, the deferment of outstanding loan
repayment and the refinancing of bridge financing obligations. The alliance
continues to evolve and recent events under the alliance are described in this
Note 5.
On
February 25, 2008, the Company entered into a research agreement (RA8) with an
affiliate of Alticor, effective January 1, 2008, to expand the research
being performed under its current agreements with Alticor through 2008. The
Company received $1,200,000 during 2008 under the research agreement, on a time
and materials basis. Additionally, in 2009 and 2008 the Company recognized as
revenue approximately $524,000 and $800,000, respectively of previously deferred
revenue. In addition to the $800,000 of deferred revenue recognized under RA8,
$168,254 of funds previously paid to the Company by Alticor under research
agreement 3 (RA3) and research agreement 4 (RA4), for which no work has been
performed, will not need to be repaid to Alticor by the Company. Since the
Company performed no prior services relating to the $168,254 received from
Alticor, and the Company is not required to perform any future services relating
to these funds, the Company has determined that the funds should be classified
as additional paid-in capital and are recorded as such on the Company’s balance
sheet.
On
January 31, 2009, the Company entered into an amendment to the RA8. The
amendment extended the term from a maximum of six months to eight months,
terminating on September 30, 2009. The Company received an additional $200,316
on March 31, 2009 under the terms of the amendment to complete ongoing research,
which was recognized as deferred revenue on the Company’s balance sheet as of
March 31, 2009. At December 31, 2009, all research agreements with Alticor were
complete and the $200,316 has been recognized as revenue.
On
August 17, 2006, our existing credit facility with Pyxis Innovations Inc.,
an affiliate of Alticor (“Pyxis”), was amended to provide the Company with
access to approximately $14,400,000 of additional working capital borrowings at
any time prior to August 17, 2008. Any amounts borrowed bear interest at
prime, require quarterly interest payments and on demand a payment of all
outstanding principal on August 16, 2011. The principal amount of any
borrowing under this credit facility is convertible at Pyxis’ election into a
maximum of 2,533,234 shares of common stock, reflecting a conversion price of
$5.6783 per share.
On
June 11, 2008, pursuant to the terms of the notes, Pyxis Innovations Inc.,
an affiliate of Alticor, converted the indebtedness due on June 30, 2008,
representing an aggregate principal amount of $595,336 and accrued interest of
$7,450, into 943,032 shares of the Company’s common stock.
This
credit facility has been extended several times, most recently on February 1,
2010 to permit borrowings at anytime prior to June 30, 2011. As of December 31,
2009, there was $7,000,000 in principal outstanding under the credit facility.
On November 9, 2009 the Company borrowed $2,000,000 leaving $7,316,255 of
available credit and $7,000,000 in principal outstanding under the credit
facility. On February 1, 2010 the Company borrowed an additional $2,000,000
leaving $5,316,255 of available credit and $9,000,000 in principal outstanding
under the credit facility.
Note 7—Fixed
Assets, Net
Fixed
assets useful lives and balances for continuing operations at December 31,
2009 and 2008 consisted of the following:
|
|
|
|
|
|
|
|
Computer
software, computer equipment and office equipment
|
3 years
|
|
$
|
344,557
|
|
|
$
|
306,989
|
|
R&D
lab equipment
|
5 years
|
|
|
269,197
|
|
|
|
269,197
|
|
Genetic
testing lab and equipment
|
5 years
|
|
|
1,312,079
|
|
|
|
965,760
|
|
Furniture
and fixtures
|
5 years
|
|
|
40,349
|
|
|
|
40,349
|
|
Leasehold
improvements
|
5 years
|
|
|
265,563
|
|
|
|
265,563
|
|
Website
Development
|
3 years
|
|
|
270,678
|
|
|
|
—
|
|
Equipment
under capital leases
|
3
to 5 years
|
|
|
22,920
|
|
|
|
22,920
|
|
|
|
|
|
2,525,343
|
|
|
|
1,870,778
|
|
Less —
Accumulated depreciation and amortization
|
|
|
|
(1,755,362
|
)
|
|
|
(1,435,298
|
)
|
Total
|
|
|
$
|
769,981
|
|
|
$
|
435,480
|
|
Depreciation
and amortization expense of these fixed assets for continuing operations was
$379,503, $278,617, and $291,813 for the years ended December 31, 2009,
2008, 2007, respectively.
Note 8—Intangible
Assets
The
intangible assets’ useful lives and balances at December 31, 2009 and 2008
consisted of the following:
|
|
|
|
|
|
|
Intangible
assets:
|
|
|
|
|
|
|
Patent
Costs
|
|
$
|
1,154,523
|
|
|
$
|
1,183,521
|
|
Less —
Accumulated amortization
|
|
|
(409,033
|
)
|
|
|
(293,580
|
)
|
Net
intangible assets of continuing operations
|
|
|
745,490
|
|
|
|
889,941
|
|
Net
intangible assets of discontinued operations
|
|
|
—
|
|
|
|
3,869,212
|
|
Total
intangible assets
|
|
$
|
745,490
|
|
|
$
|
4,759,153
|
|
On March
25, 2008, The Company entered into an agreement with David A. Finkelstein
and Timothy J. Richerson regarding the acquisition of the assets and
business of the Alan James Group. Under the agreement, Finkelstein and Richerson
agreed to release the Company from any further obligations under the Asset
Purchase Agreement, relating to the acquisition of the assets and business of
the Alan James Group on August 17, 2006. Finkelstein and Richerson agreed
that no further amounts are or will become due under the Purchase Agreement
(including its earn-out provisions), their Employment Agreements or other
related documents. Pursuant to the terms of a settlement agreement between the
Company and former officers of the Alan James Group including the acquisition of
the assets and business of the Alan James Group, the Company agreed to pay a
total of $1,200,000. The $1,200,000 due to sellers is recorded as a current
liability at December 31, 2007. The Company applied $600,000 of the
settlement cost against the previously accrued separation expense that was
recorded on June 30, 2007 and the remaining $600,000 was applied against
the $2,130,374 aggregate total of contingent liabilities and amounts due under
escrow recorded as part of the original acquisition. The remaining contingent
liabilities and amounts due under escrow balance of $1,530,374 was eliminated as
no longer due and applied as a reduction in the balances on a pro rata basis of
the intangibles assets recorded as part of the original acquisition, including
the effect of term reduction on the non-compete agreements.
If the
amount initially recognized as if it was a liability exceeds the fair value of
the consideration issued or issuable, that excess shall be allocated as a pro
rata reduction of the amounts assigned to assets acquired in accordance with
FASB ASC 805. The intangible balances as of December 31, 2007 reflect the
resolution of the contingency resulting from the acquisition of the assets and
business of the Alan James Group.
Prior to
opening of business on July 1, 2009, we determined that due to the sale of
substantially all of the assets of Alan James Group business and assets of its
wholly-owned subsidiary, AJG Brands, Inc., $3,251,838 of intangible assets
became permanently impaired and were expensed.
Patent
amortization expense for continuing operations was $115,453, $100,693 and
$73,223 for the years ended December 31, 2009, 2008 and 2007,
respectively.
Note 9—Accrued
Expenses
Accrued
expenses consist of the following:
|
|
December 31
|
|
|
|
2009
|
|
|
2008
|
|
Payroll
and vacation
|
|
$
|
123,217
|
|
|
$
|
102,337
|
|
Other
|
|
|
158,589
|
|
|
|
94,686
|
|
Total
accrued expenses of continuing operations
|
|
|
281,806
|
|
|
|
197,023
|
|
Total
accrued expenses of discontinued operations
|
|
|
1,123,049
|
|
|
|
1,623,521
|
|
Total
accrued expenses
|
|
$
|
1,404,855
|
|
|
$
|
1,820,544
|
|
At
December 31, 2009 accrued returns and accrued trade promotions relate to the non
acquired accounts as a result of the sale of substantially all of the Alan James
Group business and assets of our wholly-owned subsidiary, AJG Brands, Inc. Prior
to July 1, 2009 accrued returns related to future returns of OTCeutical products
that were shipped prior to the Company’s acquisition of the Alan James Group
business.
Note 10—Commitments
and Contingencies
The
Company leases its offices and laboratory space under non-cancelable operating
leases expiring at various dates through March 2014. The Company also leases
certain office equipment under lease obligations, all of which are classified as
operating leases. Future minimum lease commitments under lease agreements with
initial or remaining terms of one year or more at December 31, 2009, are as
follows:
Year Ending December 31,
|
|
|
|
2010
|
|
|
451,563
|
|
2011
|
|
|
459,569
|
|
2012
|
|
|
463,128
|
|
2013
|
|
|
472,623
|
|
2014
|
|
|
118,749
|
|
Thereafter
|
|
|
—
|
|
|
|
$
|
1,965,632
|
|
Rent
expense was $519,536, $603,498, and $599,285 for the years ended
December 31, 2009, 2008, and 2007, respectively.
Off-Balance
Sheet Arrangements
The
Company has no off-balance sheet arrangements that have, or are reasonably
likely to have, a current or future effect on its financial condition, results
of operations and cash flows.
Note 11—Capital
Stock
Authorized
Preferred and Common Stock
At December 31, 2009, the Company had
authorized 6,000,000 shares of $0.001 par value Series A Preferred Stock,
of which 5,000,000 were issued and outstanding. At December 31, 2009, the
Company had authorized 100,000,000 shares of $0.001 par value common stock of
which 66,408,082 shares were outstanding or reserved for issuance. Of those,
32,102,435 shares were outstanding; 28,160,200 shares were reserved for the
conversion of Series A Preferred to common stock; 1,232,763 shares were
reserved for the conversion of the $7,000,000 of debt outstanding under the
credit facility with Pyxis; 2,951,095 shares were reserved for the potential
exercise of authorized and outstanding stock options; 400,000 shares were
reserved for the exercise of outstanding warrants to purchase common stock at an
exercise price of $2.50 per share which are exercisable currently until the
expiration date of August 9, 2012; 273,130 shares were reserved for the
potential exercise of rights held under the Employee Stock Purchase Plan; and
1,288,459 shares were reserved for the issuance upon the conversion of
convertible notes that may be issued to Pyxis under the existing credit
facility.
Series A
Preferred Stock
On
March 5, 2003, the Company entered into a Stock Purchase Agreement with
Pyxis, pursuant to which Pyxis purchased from the Company 5,000,000 shares of
Series A Preferred Stock for $7,000,000 in cash on that date, and an
additional $2,000,000 in cash that was paid, as a result of the Company
achieving a certain milestone, on March 11, 2004.
The
Series A Preferred Stock accrues dividends at the rate of 8% of the
original purchase price per year, payable only when, as and if declared by the
Board of Directors and are non-cumulative. To date, no dividends have been
declared on these shares. If the Company declares a distribution, with certain
exceptions, payable in securities of other persons, evidences of indebtedness
issued by the Company or other persons, assets (excluding cash dividends) or
options or rights to purchase any such securities or evidences of indebtedness,
then, in each such case the holders of the Series A Preferred Stock shall
be entitled to a proportionate share of any such distribution as though the
holders of the Series A Preferred Stock were the holders of the number of
shares of our Common Stock into which their respective shares of Series A
Preferred Stock are convertible as of the record date fixed for the
determination of the holders of our Common Stock entitled to receive such
distribution.
In the
event of any liquidation, dissolution or winding up of the Company, whether
voluntary or involuntary, the holders of the Series A Preferred Stock shall
be entitled to receive, prior and in preference to any distribution of any of
the Company’s assets or surplus funds to the holders of its Common Stock by
reason of their ownership thereof, the amount of two times the then-effective
purchase price per share, as adjusted for any stock dividends, combinations or
splits with respect to such shares, plus all declared but unpaid dividends on
such share for each share of Series A Preferred Stock then held by them.
The liquidation preference at December 31, 2009 was $18,000,000. After
receiving this amount, the holders of the Series A Preferred Stock shall
participate on an as-converted basis with the holders of common stock in any of
the remaining assets.
Each
share of Series A Preferred Stock is convertible at any time at the option
of the holder into a number of shares of the Company’s common stock determined
by dividing the then-effective purchase price ($1.80, and subject to further
adjustment) by the conversion price in effect on the date the certificate is
surrendered for conversion. As of December 31, 2009, the Series A
Preferred Stock was convertible into 28,160,200 shares of Common Stock
reflecting a current conversion price of $0.3196 per share.
Each
holder of Series A Preferred Stock is entitled to vote its shares of
Series A Preferred Stock on an as-converted basis with the holders of
Common Stock as a single class on all matters submitted to a vote of the
stockholders, except as otherwise required by applicable law. This means that
each share of Series A Preferred Stock will be entitled to a number of
votes equal to the number of shares of Common Stock into which it is convertible
on the applicable record date.
Note 12—Stock-Based
Compensation Arrangements
Stock-based
compensation arrangements consisted of the following as of December 31,
2009: three share-based compensation plans, restricted stock awards; an employee
stock purchase plan; and employee compensation agreements. Total compensation
cost that has been charged against income for stock-based compensation
arrangements is as follows:
During
the years 2009, 2008, and 2007, the Company granted stock options to purchase
138,500, 852,000, and 26,000 shares of common stock, respectively, to employees
and directors. For purposes of determining the stock-based compensation expense
for grant awards issued after January 1, 2006, the Black-Scholes
option-pricing model was used with the following weighted-average
assumptions:
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
|
2.69
|
%
|
|
|
3.2
|
%
|
|
|
4.6
|
%
|
Expected
life, years
|
|
|
4.65
|
|
|
|
6.5
|
|
|
|
7.0
|
|
Expected
volatility
|
|
|
101.4
|
%
|
|
|
83.7
|
%
|
|
|
83.0
|
%
|
Using
these assumptions, the weighted average grant date fair value of options granted
in 2009, 2008 and 2007 was $0.20, $0.81 and $0.90 respectively.
Restricted
Stock Awards
Holders
of restricted stock awards participate fully in the rewards of stock ownership
of the Company, including voting and dividend rights. Recipients of restricted
stock awards are generally not required to pay any consideration to the Company
for these restricted stock awards. The Company measures the fair value of the
shares based on the last reported price at which the Company’s common stock
traded on the date of the grant and compensation cost is recognized over the
remaining service period. During each of the years ended December 31, 2009, 2008
and 2007, the Company granted restricted stock awards of 12,500 shares under an
employment agreement dated March 31, 2006.
Employee
Stock Purchase Plan
Purchases
made under the Company’s Employee Stock Purchase Plan are now deemed to be
compensatory under FASB ASC 718,
Compensation-Stock
Compensation
because employees may purchase stock at a price equal to 85%
of the fair market value of the Company’s common stock on either the first day
or the last day of a calendar quarter, whichever is lower. During the years
ended December 31, 2009 and 2008, employees purchased 149,054 and 11,747
shares, respectively, of common stock at a weighted-average purchase price of
$0.23 and $0.87, while the weighted-average fair market value was $0.27 and
$1.03 per share, resulting in compensation expense of $5,916 and $1,774, in 2009
and 2008, respectively.
Employment
Agreements
On March
13, 2009, Lewis Bender received a cash bonus of $102,850 pursuant to his
employment agreement and elected to receive $29,700 in 110,000 shares of our
common stock. On March 13, 2009, Eliot Lurier received a cash bonus of $43,695
pursuant to his employment agreement and elected to receive $4,455 in 16,500
shares of our common stock. During the year ended December 31, 2009, 12,500
shares of restricted stock vested pursuant to an employment agreement with Dr.
Kornman. The Company measures the fair value of the shares, prior to issuance,
based on the last reported price at which the Company’s common stock traded for
the reporting period and compensation cost is recognized ratably over the
employment period required to earn the stock award. At time of issuance, the
Company will measure the fair value of the shares based on the last reported
price at which the Company’s common stock traded on the date of the issuance and
will record a cumulative adjustment, if any.
On
January 21, 2010, the Company entered into a one-year employment agreement with
Lewis H. Bender for the position of Chief Executive Officer. The agreement
replaced and superceded the employment agreement between the Company and Mr.
Bender that was to expire by its terms on January 22, 2010. The agreement has an
initial term of one year and is automatically renewable for successive one year
periods unless at least 90 days prior notice is given by either the Company or
Mr. Bender. The agreement also provides that Mr. Bender will serve as a member
of the Company’s Board of Directors for as long as he serves as the Company’s
Chief Executive Officer, subject to any required approval of the Company’s
shareholders.
The
agreement provides for a minimum annual base salary of $340,000 and an annual
discretionary bonus of up to 50% of his base salary based upon the Company’s
financial performance. Under the terms of the agreement, Mr. Bender has also
been granted an option to purchase 100,000 shares of the Company’s common stock
at an exercise price equal to $0.89 per share, which option was exercisable
immediately upon grant.
The
agreement is terminable by the Company for cause or upon thirty days prior
written notice without cause and by Mr. Bender upon thirty days prior written
notice for “good reason” (as defined in the agreement) or upon ninety days prior
written notice without good reason. If the Company terminates Mr. Bender without
cause or Mr. Bender terminates his employment for good reason, then the Company
will pay Mr. Bender, in addition to any accrued, but unpaid compensation prior
to the termination, an amount equal to eighteen months of his base salary. If
the Company terminates Mr. Bender without cause or Mr. Bender terminates his
employment with good reason after a “change of control” (as defined in the
agreement), then the Company will pay Mr. Bender, in addition to any accrued,
but unpaid compensation prior to the termination, an amount equal to twenty-four
months of his base salary, and all unvested stock options will automatically
vest.
As of
December 31, 2009, no shares of the Company’s common stock have been issued
pursuant to these agreements. The recognition of compensation expense for this
type of award did not change as a result of adopting FASB ASC 718,
Compensation-Stock
Compensation
on January 1, 2006. The Company measures the fair value
of the shares, prior to issuance, based on the last reported price at which the
Company’s common stock traded for the reporting period and compensation cost is
recognized ratably over the employment period required to earn the stock award.
At time of issuance, the Company will measure the fair value of the shares based
on the last reported price at which the Company’s common stock traded on the
date of the issuance and will record a cumulative adjustment, if
any.
A summary
of stock compensation cost included in the statement of operations for the year
ended December 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations:
|
|
|
|
|
|
|
|
|
|
Cost
of revenue
|
|
$
|
7,280
|
|
|
$
|
21,775
|
|
|
$
|
25,961
|
|
Research
and development expenses
|
|
|
31,663
|
|
|
|
27,020
|
|
|
|
114,546
|
|
Selling,
general and administrative expenses
|
|
|
154,969
|
|
|
|
104,492
|
|
|
|
32,657
|
|
Total
continuing operations
|
|
|
193,912
|
|
|
|
153,287
|
|
|
|
173,164
|
|
Discontinued
operations
|
|
|
38,777
|
|
|
|
6,836
|
|
|
|
—
|
|
Total
|
|
$
|
232,689
|
|
|
$
|
160,123
|
|
|
$
|
173,164
|
|
Stock
Option Plans
In June
1996, the Company’s shareholders approved the adoption of the 1996 Equity
Incentive Plan (the 1996 Plan). The 1996 Plan provides for the award of
nonqualified and incentive stock options, restricted stock and stock bonuses to
employees, directors, officers and consultants of the Company. A total of
1,300,000 shares of the Company’s common stock had been reserved for award under
the 1996 Plan of which 369,839 remained unissued at December 31, 2007. This
plan has been terminated with respect to new grants.
In June
2000, the Company’s shareholders approved the adoption of the Interleukin
Genetics, Inc. 2000 Employee Stock Compensation Plan (the 2000 Plan). The
2000 Plan provides for the award of nonqualified and incentive stock options,
restricted stock, and stock awards to employees, directors, officers, and
consultants of the Company. A total of 2,000,000 shares of the Company’s common
stock have been reserved for award under the 2000 Plan of which 93,232 were
available for future issuance at December 31, 2009.
In June
2004, the Company’s shareholders approved the adoption of the Interleukin
Genetics, Inc. 2004 Employee Stock Compensation Plan (the 2004 Plan). The
2004 Plan provides for the award of nonqualified and incentive stock options,
restricted stock, and stock awards to employees, directors, officers, and
consultants of the Company. A total of 2,000,000 shares of the Company’s common
stock have been reserved for award under the 2004 Plan of which 1,287,946 were
available for future issuance at December 31, 2009.
Nonqualified
and incentive stock options with a life of 10 years are granted at exercise
prices equal to the fair market value of the common stock on the date of grant.
Options generally vest over a period of three to five years.
A summary
of the status of the Company’s stock options, issued under the 1996, 2000 and
2004 Plans and outside of these plans, at December 31, 2009, 2008 and 2007,
and changes during these years is presented in the tables
below:
The
following table details all stock option activity for the years ended
December 31, 2009, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
Outstanding,
beginning of year
|
|
|
2,100,917
|
|
|
$
|
2.33
|
|
|
|
1,366,406
|
|
|
$
|
3.11
|
|
|
|
1,893,015
|
|
|
$
|
2.99
|
|
Granted
|
|
|
138,500
|
|
|
|
0.26
|
|
|
|
852,000
|
|
|
|
1.09
|
|
|
|
26,000
|
|
|
|
1.21
|
|
Exercised
|
|
|
(15,000
|
)
|
|
|
0.26
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(194,917
|
)
|
|
|
1.78
|
|
Expired
|
|
|
(645,500
|
)
|
|
|
2.56
|
|
|
|
(117,489
|
)
|
|
|
2.40
|
|
|
|
(357,692
|
)
|
|
|
3.06
|
|
Outstanding,
end of year
|
|
|
1,578,917
|
|
|
$
|
2.07
|
|
|
|
2,100,917
|
|
|
$
|
2.33
|
|
|
|
1,366,406
|
|
|
$
|
3.11
|
|
Exercisable,
end of year
|
|
|
987,067
|
|
|
$
|
2.75
|
|
|
|
1,372,417
|
|
|
$
|
2.96
|
|
|
|
1,313,906
|
|
|
$
|
3.13
|
|
The
following table details further information regarding stock options outstanding
and exercisable at December 31, 2009:
|
|
Stock Options Outstanding
|
|
|
Stock Options Exercisable
|
|
|
|
|
|
|
Weighted Avg
remaining
contractual life
(years)
|
|
|
Weighted Avg
Exercise
Price
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
$0.00–$1.00
|
|
|
242,500
|
|
|
|
8.15
|
|
|
$
|
0.44
|
|
|
|
82,700
|
|
|
$
|
0.64
|
|
$1.01–$2.00
|
|
|
849,250
|
|
|
|
6.74
|
|
|
|
1.18
|
|
|
|
417,200
|
|
|
|
1.19
|
|
$2.01–$3.00
|
|
|
5,000
|
|
|
|
1.49
|
|
|
|
2.62
|
|
|
|
5,000
|
|
|
|
2.62
|
|
$3.01–$4.00
|
|
|
87,667
|
|
|
|
3.19
|
|
|
|
3.65
|
|
|
|
87,667
|
|
|
|
3.65
|
|
$4.01–$5.00
|
|
|
394,500
|
|
|
|
2.30
|
|
|
|
4.65
|
|
|
|
394,500
|
|
|
|
4.65
|
|
$0.01–$5.00
|
|
|
1,578,917
|
|
|
|
5.63
|
|
|
$
|
2.07
|
|
|
|
987,067
|
|
|
$
|
2.75
|
|
Aggregate
intrinsic value
|
|
$
|
103,656
|
|
|
|
|
|
|
|
|
|
|
$
|
19,853
|
|
|
|
|
|
The
aggregate intrinsic value in the preceding table represents the total pre-tax
intrinsic value, based on the last reported price at which the Company’s common
stock traded on December 31, 2009, the last trading day of fiscal 2009, of
$0.86, which would have been received by the option holders had they exercised
their options as of that date.
The
following table summarizes the status of the Company’s non-vested options for
the years ended December 31, 2009, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
|
|
|
|
Weighted Avg
Exercise
Price
|
|
Non-vested
options, beginning of year
|
|
|
728,500
|
|
|
$
|
1.14
|
|
|
|
52,500
|
|
|
$
|
2.60
|
|
|
|
247,000
|
|
|
$
|
3.29
|
|
Granted
|
|
|
138,500
|
|
|
|
0.22
|
|
|
|
852,000
|
|
|
|
1.09
|
|
|
|
26,000
|
|
|
|
1.21
|
|
Vested
|
|
|
(222,250
|
)
|
|
|
0.83
|
|
|
|
(147,000
|
)
|
|
|
1.25
|
|
|
|
(30,750
|
)
|
|
|
3.63
|
|
Forfeited
|
|
|
(52,900
|
)
|
|
|
1.03
|
|
|
|
(29,000
|
)
|
|
|
2.07
|
|
|
|
(189,750
|
)
|
|
|
3.14
|
|
Non-vested
options, end of year
|
|
|
591,850
|
|
|
$
|
0.94
|
|
|
|
728,500
|
|
|
$
|
1.14
|
|
|
|
52,500
|
|
|
$
|
2.60
|
|
As of
December 31, 2009 and 2008, there was approximately $347,000 and $600,000,
respectively, of total unrecognized cost related to non-vested share-based
compensation arrangements granted under the Company’s stock plans. That cost is
expected to be recognized over a weighted average period of approximately
five years. Options to purchase 15,000 shares were exercised during the
year ended December 31, 2009, and no options were exercised in 2008; these
options had an intrinsic value of approximately $3,150 and $0 on their date of
exercise, respectively. The fair value of stock options that vested during the
year ended December 31, 2009 and 2008 was approximately
$188,000.
Note 13—Employee
Benefit Plan
In 1998,
the Company adopted a profit sharing plan covering substantially all of its
employees. Under the profit sharing plan, the Company may, at the discretion of
the Board of Directors, contribute a portion of the Company’s current or
accumulated earnings. In September 1998, the Company amended and restated the
profit sharing plan to include provisions for Section 401(k) of the
Internal Revenue Code, which allowed for pre-tax employee contributions to the
plan. Under the amended and restated plan, the Company may, at the discretion of
the Board of Directors, match a portion of the participant contributions. The
Company currently contributes 25% of any amount employees contribute, up to a
maximum of $1,500 per participant per calendar year. Company contributions, if
any, are credited to the participants’ accounts and vest over a period of five
years based on the participants’ initial service date with the Company. During
the years ended December 31, 2009, 2008 and 2007, $19,740, $21,639, and
$10,199, respectively, was contributed to the plan.
Note 14—Income
Taxes
For the
years ended December 31, 2009, 2008 and 2007, the provision for income
taxes was $53,000, $26,102, and $15,500, respectively. The Company’s federal
statutory income tax rate for 2009, 2008 and 2007 was 34%. The Company used a
blended federal and state income tax rate of 37%, 39% and 40% for 2009, 2008 and
2007, respectively. Interleukin Genetics, Inc. has incurred losses from
operations but has not recorded an income tax benefit for 2009, 2008 or 2007 as
the Company has recorded a valuation allowance against its net operating losses
and other net deferred tax assets due to uncertainties related to the
realizability of these tax assets. Interleukin Brands, Inc. incurred losses
in 2009 and had taxable income for 2008 and 2007. Interleukin Brands, Inc.
recorded a state income tax benefit for 2007 due to utilization of the net
operating loss generated in 2006, against which a valuation allowance was
recorded, and from expectations concerning realizability of deferred tax assets.
The state tax expense and benefit recorded by Interleukin Brands, Inc. is a
result of filing in separate entity filing jurisdictions.
Deferred
tax assets and liabilities are determined based on the difference between
financial statement and tax bases using enacted federal and state tax rates in
effect for the year in which the differences are expected to reverse. As of
December 31, 2009 and 2008, the approximate income tax effect of the
Company’s deferred tax assets (liabilities) consisted of the
following:
|
|
|
|
|
|
|
Deferred
tax asset:
|
|
|
|
|
|
|
Tax
effect of:
|
|
|
|
|
|
|
Net
operating loss carryforwards
|
|
$
|
24,029,000
|
|
|
$
|
20,926,000
|
|
Accrued
expenses
|
|
|
399,000
|
|
|
|
615,000
|
|
Amortization
of definite lived intangible assets
|
|
|
19,000
|
|
|
|
1,332,000
|
|
Non-qualified
stock option compensation
|
|
|
167,000
|
|
|
|
193,000
|
|
Depreciation
|
|
|
91,000
|
|
|
|
83,000
|
|
Other
|
|
|
1,000
|
|
|
|
59,000
|
|
Patents
|
|
|
(253,000
|
)
|
|
|
(359,000
|
)
|
Research
tax credit carryforwards
|
|
|
1,827,000
|
|
|
|
1,630,000
|
|
Total
deferred tax assets
|
|
|
26,280,000
|
|
|
|
24,479,000
|
|
Valuation
allowance
|
|
|
(26,280,000
|
)
|
|
|
(24,421,000
|
)
|
Net
deferred tax assets
|
|
|
-
|
|
|
|
58,000
|
|
Deferred
tax liability:
|
|
|
|
|
|
|
|
|
Amortization
of indefinite lived intangible assets
|
|
|
-
|
|
|
|
(5,000
|
)
|
Net
deferred tax assets
|
|
$
|
-
|
|
|
$
|
53,000
|
|
A portion of the funds
received from Alticor and its subsidiaries for research and other agreements are
reflected as equity in the financial statements but are reported as revenue for
tax purposes.
In 2007, n
o funds received from
Alticor and its subsidiaries were reflected as equity. I
n 2008, the
Company recognized $168,254 of funds previously paid to the Company by Alticor
under research agreement 3 (RA3) and research agreement 4 (RA4), for which no
work has been performed and will not need to be repaid to Alticor by the
Company. Since the Company performed no prior services relating to the $168,254
received from Alticor, and the Company is not required to perform any future
services relating to these funds, the Company has determined that the funds
should be classified as additional paid-in capital and are recorded as such on
the Company’s balance sheet as of December 31, 2008. In 2009, no funds received
from Alticor and its subsidiaries were reflected as equity.
As of
December 31, 2009, the Company had gross net operating loss (NOL) and
research tax credit carryforwards of approximately $73.2 million and $1.3
million, respectively, for federal income tax purposes, expiring in varying
amounts through the year 2029. Of the $73.2 million NOL loss carryforward,
$2.5 million relates to stock-based compensation and has not been reflected
in the deferred taxes and when the benefit of these losses, if any, is realized,
the result is a credit to additional paid in capital as a component of
stockholder’s equity.
As of
December 31, 2009, the Company had a research tax credit carryforward of
approximately $.7 million for state income tax purposes, expiring in varying
amounts through the year 2024.
The
Company’s ability to use its NOL and tax credit carryforwards to reduce future
taxes is subject to the restrictions provided by Section 382 of the
Internal Revenue Code of 1986. These restrictions provide for limitations on the
Company’s utilization of its NOL and tax credit carryforwards following a
greater than 50% ownership change during the prescribed testing period. On
March 5, 2003, the Company had such a change. As a result, all of the
Company’s NOL carryforwards as of that date are limited in utilization. The
annual limitation may result in the expiration of certain of the carryforwards
prior to utilization.
The
provision for income taxes differs from the federal statutory rate due to the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
at statutory rate
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
|
|
(34.0
|
)%
|
State
taxes, net of federal benefit
|
|
|
0.5
|
|
|
|
(6.5
|
)
|
|
|
(6.1
|
)
|
Research
and Experimentation credit
|
|
|
(1.8
|
)
|
|
|
(2.6
|
)
|
|
|
(2.9
|
)
|
Research
payments
|
|
|
—
|
|
|
|
0.9
|
|
|
|
—
|
|
Share
Based Payment expense
|
|
|
0.7
|
|
|
|
0.7
|
|
|
|
0.8
|
|
Forfeited
prepayment of genetic test services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Other
|
|
|
0.6
|
|
|
|
(5.7
|
)
|
|
|
5.6
|
|
Change
in valuation allowance
|
|
|
34.5
|
|
|
|
47.6
|
|
|
|
36.8
|
|
Effective
tax rate
|
|
|
0.5
|
%
|
|
|
0.4
|
%
|
|
|
0.2
|
%
|
Note 15—Segment
Information
The
Company applies the provisions of FASB ASC 280,
Segment Reporting
, which
established standards for reporting information about operating segments in
annual and interim financial statements, and requires that companies report
financial and descriptive information about their reportable segments based on
management’s approach. The standard also established related disclosures about
products and services, geographic areas and major customers. As a result of the
acquisition of the assets and business of the Alan James Group in August 2006
and until prior to the opening of business on July 1, 2009 when substantially
all of the assets and business were sold, the Company had two reportable
segments: Personalized Health and Consumer Products.
As of
December 31, 2009 the Company has one segment remaining, the genetic test
business, which was formerly defined as the Personalized Health segment and is
reflected as continuing operations. The Company develops genetic tests for sale
into the emerging personalized health market and performs testing services that
can help individuals improve and maintain their health through preventive
measures. The Company’s principal operations and markets are located in the
United States.
Note 16—Selected
Quarterly Financial Data (Unaudited)
The
following are selected quarterly financial data for continuing and discontinued
operations for the years ended December 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
347,464
|
|
|
$
|
222,993
|
|
|
$
|
322,882
|
|
|
$
|
185,091
|
|
Gross
profit (loss)
|
|
|
42,492
|
|
|
|
(78,882
|
)
|
|
|
17,579
|
|
|
|
(106,406
|
)
|
Loss
from continuing operations
|
|
|
(2,347,081
|
)
|
|
|
(2,316,409
|
)
|
|
|
(2,544,714
|
)
|
|
|
(1,821,492
|
)
|
Income
(loss) from discontinued operations
|
|
|
(67,167
|
)
|
|
|
20,495
|
|
|
|
40,661
|
|
|
|
31,083
|
|
Net
income (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
|
(2,380,920
|
)
|
|
|
(2,340,810
|
)
|
|
|
(2,584,933
|
)
|
|
|
(1,871,610
|
)
|
Discontinued
operations
|
|
|
(75,167
|
)
|
|
|
(1,370,707
|
)
|
|
|
40,661
|
|
|
|
31,083
|
|
Net
|
|
|
(2,456,087
|
)
|
|
|
(3,711,517
|
)
|
|
|
(2,544,272
|
)
|
|
|
(1,840,527
|
)
|
Basic
and diluted net income (loss) per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
|
(0.07
|
)
|
|
|
(0.07
|
)
|
|
|
(0.08
|
)
|
|
|
(0.06
|
)
|
Discontinued
operations
|
|
|
(0.01
|
)
|
|
|
(0.05
|
)
|
|
|
—
|
|
|
|
—
|
|
Net
|
|
|
(0.08
|
)
|
|
|
(0.12
|
)
|
|
|
(0.08
|
)
|
|
|
(0.06
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
641,872
|
|
|
$
|
521,619
|
|
|
$
|
545,594
|
|
|
$
|
911,602
|
|
Gross
profit
|
|
|
407,087
|
|
|
|
313,162
|
|
|
|
309,799
|
|
|
|
650,398
|
|
Loss
from continuing operations
|
|
|
(1,887,096
|
)
|
|
|
(1,626,859
|
)
|
|
|
(1,846,055
|
)
|
|
|
(1,632,584
|
)
|
Income
(loss) from discontinued operations
|
|
|
(21,987
|
)
|
|
|
(49,482
|
)
|
|
|
187,026
|
|
|
|
223,234
|
|
Net
income (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
|
(1,840,616
|
)
|
|
|
(1,616,863
|
)
|
|
|
(1,820,875
|
)
|
|
|
(1,654,720
|
)
|
Discontinued
operations
|
|
|
(34,487
|
)
|
|
|
(49,482
|
)
|
|
|
179,026
|
|
|
|
186,632
|
|
Net
|
|
|
(1,875,103
|
)
|
|
|
(1,666,345
|
)
|
|
|
(1,641,849
|
)
|
|
|
(1,468,088
|
)
|
Basic
and diluted net income (loss) per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
|
(0.06
|
)
|
|
|
(0.05
|
)
|
|
|
(0.06
|
)
|
|
|
(0.05
|
)
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
0.01
|
|
|
|
—
|
|
Net
|
|
|
(0.06
|
)
|
|
|
(0.05
|
)
|
|
|
(0.05
|
)
|
|
|
(0.05
|
)
|
Note 17—Industry
Risk and Concentration
The
Company develops genetic risk assessment tests under contract, performs research
for its own benefit and provides research services to a collaborative partner.
As of December 31, 2009, the Company has introduced four genetic risk assessment
tests commercially. Two of the tests are branded and sold through the Company’s
strategic partner — Alticor. Commercial success of the Company’s genetic
risk assessment tests will depend on their success as scientifically credible
and cost-effective by consumers and the marketing success of the Company and its
collaborative partner.
Research
in the field of disease predisposing genes and genetic markers is intense and
highly competitive. The Company has many competitors in the United States and
abroad that have considerably greater financial, technical, marketing, and other
resources available. If the Company does not discover disease predisposing genes
or genetic markers and develop risk assessment tests and launch such services or
products before its competitors, then the potential for significant revenues may
be reduced or eliminated.
Prior to
the sale of substantially all of the Alan James Group business and assets of the
Company’s wholly-owned subsidiary, AJG Brands, Inc., for the twelve months ended
December 31, 2009 and 2008, approximately 52.1% and 51.7%, respectively, of the
Company’s consumer products revenue was from a single customer. As of December
31, 2008, approximately 47.6% of the trade accounts receivables were from that
same customer; the Company had no trade accounts receivable from this customer
as of December 31, 2009.
Prior to
the sale of substantially all of the Alan James Group business and assets of the
Company’s wholly-owned subsidiary, AJG Brands, Inc., the majority of the
Company’s consumer products were sourced from three suppliers. The Company paid
a contracted rate per completed unit for each product. The suppliers were
responsible for procuring raw materials and packaging finished
products.
Our
significant customer, Alticor, which is our principal shareholder, represented
approximately 87.7% of our revenues from continuing operations in the twelve
months ended December 31, 2009.
Note 18—Subsequent
Events
On
January 21, 2010, the Company entered into an employment agreement with Lewis H.
Bender, its Chief Executive Officer. The agreement replaced and superceded the
employment agreement between the Company and Mr. Bender that was to expire by
its terms on January 22, 2010. The agreement has an initial term of one year and
is automatically renewable for successive one year periods unless at least 90
days prior notice is given by either the Company or Mr. Bender. The agreement
also provides that Mr. Bender will serve as a member of the Company’s Board of
Directors for as long as he serves as the Company’s Chief Executive Officer,
subject to any required approval of the Company’s shareholders.
The
agreement is terminable by the Company for cause or upon thirty days prior
written notice without cause and by Mr. Bender upon thirty days prior written
notice for “good reason” (as defined in the agreement) or upon ninety days prior
written notice without good reason. If the Company terminates Mr. Bender without
cause or Mr. Bender terminates his employment for good reason, then the Company
will pay Mr. Bender, in addition to any accrued, but unpaid compensation prior
to the termination, an amount equal to eighteen months of his base salary. If
the Company terminates Mr. Bender without cause or Mr. Bender terminates his
employment with good reason after a “change of control” (as defined in the
agreement), then the Company will pay Mr. Bender, in addition to any accrued,
but unpaid compensation prior to the termination, an amount equal to twenty-four
months of his base salary, and all unvested stock options will automatically
vest.
The
agreement also includes non-compete and non-solicitation provisions for a period
of twelve months following the termination of Mr. Bender’s employment with the
Company.
On
February 1, 2010, the Company drew down $2.0 million under our existing
convertible credit facility with Pyxis and issued a convertible promissory note
to Pyxis in that amount. A description of the credit facility is set forth in
Note 6. The principal amount of the note is due and payable on August 16, 2011.
The note bears interest at a variable rate equal to the “prime rate” and the
interest is payable quarterly. Prior to the maturity date, any portion or the
entire outstanding principal and any accrued but unpaid interest under the note
is convertible at Pyxis’s election into shares of the Company’s common stock at
a price of $5.6783 per share. Immediately following the issuance of the note on
February 1, 2010, the note was convertible into an aggregate of 352,218 shares
of the Company’s common stock. The Company had $9.0 million outstanding under
the credit facility and had $5.3 million available to borrow under the credit
facility.
On
February 1, 2010, the Company entered into the second amendment to amended and
restated note purchase agreement with Pyxis to extend the availability of the
existing credit facility with Pyxis until June 30, 2011. Prior to the second
amendment, the credit facility had been scheduled to expire on January 1,
2011.
On March
5, 2010, the Company entered into a definitive agreement with certain
institutional investors to sell $5.3 million of securities in a registered
direct offering. The investors purchased an aggregate of 4,375,002 units for
$1.20 per unit, with each unit consisting of a share of common stock and a
warrant to purchase 0.40 of a share of common stock. The warrants are
exercisable at $1.30 per share and expire in five years. Net proceeds to the
Company after fees and expenses were approximately $4.9 million.
On
February 11, 2010, Genetic Technologies Limited, or GTL, filed a complaint in
the United States District Court for the Western District of
Wisconsin. The complaint names Interleukin and eight other
corporations as defendants in an alleged patent infringement lawsuit (Genetics
Technologies Limited vs. Beckman Coulter, Inc., et. al., Civil Action No.
10-CV-00069, W.D. Wis., filed February 11, 2010). Interleukin was
served with the complaint on March 24, 2010. The complaint alleges that the
defendants make, use or sell products or services that infringe one or more
claims of the patent owned by GTL, U.S. Patent No. 5,612,179, or the ’179
Patent, which expires on March 10, 2010. In Interleukin’s case, the
complaint alleges that it offers and provides genetic risk assessment testing
services that utilize methods set forth in one or more claims of the ‘179
Patent. Interleukin believes that it has substantial defenses to the claims
asserted in the complaint.
Item 9.
Changes in and Disagreements with
Accountants on Accounting and Financial Disclosure
None
Item 9A(T).
Controls and
Procedures
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer, after evaluating
the effectiveness of our disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered
by this Annual Report on Form 10-K, have concluded that, based on such
evaluation, our disclosure controls and procedures were effective to ensure that
information required to be disclosed by us in the reports that we file or submit
under the Exchange Act is recorded, processed, summarized and reported, within
the time periods specified in the SEC’s rules and forms, and is accumulated and
communicated to our management, including our principal executive and principal
financial officers, or persons performing similar functions, as appropriate to
allow timely decisions regarding required disclosure.
Management’s
Report on Internal Control over Financial Reporting
The
management of the Company is responsible for establishing and maintaining
adequate internal control over financial reporting as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act. Because of its inherent limitations,
internal control over financial reporting may not prevent or detect
misstatements. Projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because of changes
in conditions, or that the degree of compliance with the policies or procedures
may deteriorate. The Company’s management assessed the effectiveness of the
Company’s internal control over financial reporting as of December 31, 2009. In
making this assessment, management used the criteria set forth by the Committee
of Sponsoring Organizations of the Treadway Commission (COSO) in Internal
Control-Integrated Framework. Based on our assessment, management believes that,
as of December 31, 2009, the Company’s internal control over financial reporting
is effective based on those criteria.
This
Annual Report on Form 10-K does not include an attestation report of the
Company’s registered public accounting firm regarding the Company’s internal
control over financial reporting. Management’s report on internal control over
financial reporting was not subject to attestation by the Company’s registered
public accounting firm pursuant to temporary rules of the Securities and
Exchange Commission that permit the Company to provide management’s report on
internal control over financial reporting without an accompanying attestation
report by the Company’s registered public accounting firm in this Annual Report
on Form 10-K.
Changes
in Internal Control over Financial Reporting.
There
were no changes in our internal control over financial reporting identified in
connection with the evaluation of such internal control that occurred during the
fourth quarter or our last fiscal year that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
Item 9B.
Other
Information
None
PART
III
Item 10.
Directors, Executive Officers and
Corporate Governance
Information
responsive to this item is incorporated by reference from the relevant
discussions in our Proxy Statement for the 2010 Annual Meeting of Stockholders
under the captions “Management and Corporation Governance Matters,”
“Section 16(a) Beneficial Ownership Reporting Compliance” and “Code of
Conduct and Ethics.”
Item 11.
Executive
Compensation
Information
responsive to this item is incorporated by reference from the relevant
discussions in our Proxy Statement for the 2010 Annual Meeting of Stockholders
under the captions “Executive Officer and Director Compensation,” “Management
and Corporation Governance Matters,” “Compensation Committee Interlocks and
Insider Participation,” and “Compensation Committee Report.”
Item 12.
Security Ownership of Certain
Beneficial Owners and Management and Related Stockholder
Matters
Information
responsive to this item is incorporated by reference from the relevant
discussions in our Proxy Statement for the 2010 Annual Meeting of Stockholders
under the captions “Security Ownership of Certain Beneficial Owners and
Management” and “Equity Compensation Plan Information.”
Item 13.
Certain Relationships and Related
Transactions, and Director Independence
Information
responsive to this item is incorporated by reference from the relevant
discussions in our Proxy Statement for the 2010 Annual Meeting of Stockholders
under the captions “Certain Relationships and Related Transactions” and
“Management and Corporate Governance Matters.”
Item 14
Principal
Accountant Fees and Services
Information
responsive to this item is incorporated by reference from the relevant
discussions in our Proxy Statement for the 2010 Annual Meeting of Stockholders
under the caption “Principal Accountant Fees and Services.”
PART
IV
Item 15.
Exhibits
Item 15(a).
|
|
The
following documents are filed as part of this Annual Report on Form
10-K:
|
|
|
|
Item 15(a)(1)
and (2).
|
|
See
“Index to Financial Statements” at Item 8 to this Annual Report on
Form 10-K. Other financial statement schedules have not been included
because they are not applicable or the information is included in the
financial statements or notes thereto.
|
|
|
|
Item
15(a)(3)
|
|
Exhibits:
|
The
exhibits listed below are filed as part of or incorporated by reference into
this Annual Report. Where certain exhibits are incorporated by reference from a
previous filing, the exhibit numbers and previous filings are identified in
parentheses.
|
|
Identification
of Exhibit
|
2.1
|
|
Asset
Purchase Agreement by and among AJG Brands, Inc., the Company, Pep
Products, Inc. and Nutraceutical Corporation dated July 1, 2009
(incorporated by reference to Exhibit 2.1 of the Company’s Quarterly
Report on Form 10-Q filed on August 13, 2009)
|
3.1
|
|
Certificate
of Incorporation of the Company, as filed with the Delaware Secretary of
State on March 28, 2000 (incorporated herein by reference to
Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q filed
August 14, 2000)
|
3.2
|
|
Amended
and Restated Bylaws of the Company dated July 24, 2008 (incorporated by
reference to the Current Report on Form 8-K filed on July 28,
2008)
|
3.3
|
|
Certificate
of Designations, Preferences and Rights of Series A Preferred Stock,
as filed with the Delaware Secretary of State on March 5, 2003
(incorporated herein by reference to Exhibit 3.1 of the Company’s
Current Report filed on Form 8-K on March 5,
2003)
|
3.4
|
|
Certificate
of Amendment to Certificate of Incorporation, as filed with the Delaware
Secretary of State on August 5, 2003 (incorporated herein by
reference to Exhibit 3.1 of the Company’s Quarterly Report on
Form 10-Q filed on November 12, 2003)
|
3.5
|
|
Certificate
of Amendment to Certificate of Incorporation, as filed with the Delaware
Secretary of State on June 21, 2007 (incorporated herein by reference
to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q
filed on August 9, 2007)
|
4.1
|
|
Form
of Stock Certificate representing Common Stock, $0.001 par value, of the
Company (incorporated herein by reference to Exhibit 4.1 of the
Company’s Quarterly Report on Form 10-Q filed August 14,
2000)
|
4.2
|
|
Form
of Common Stock Purchase Warrant (incorporated herein by reference to
Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q
filed on November 7, 2002)
|
|
|
|
|
|
Leases
|
10.1
|
|
Commercial
Lease Agreement between the Company and Clematis LLC dated
February 13, 2004 (incorporated herein by reference to
Exhibit 10.44 of the Company’s Annual Report on Form 10-K filed
on March 29, 2004)
|
|
|
|
|
|
Equity Compensation
Plans
|
10.2@
|
|
2000
Employee Stock Compensation Plan for the Company (incorporated herein by
reference to Exhibit 10.3 of the Company’s Quarterly Report on
Form 10-Q filed August 14, 2000)
|
10.3.1@
|
|
Form
of Nonqualified Stock Option Agreement under the 2000 Employee Stock
Compensation Plan (incorporated herein by reference to Exhibit 10.4
of the Company’s Quarterly Report on Form 10-Q filed August 14,
2000)
|
10.3.2@
|
|
Form
of Incentive Stock Option Agreement under the 2000 Employee Stock
Compensation Plan (incorporated herein by reference to Exhibit 10.5
of the Company’s Quarterly Report on Form 10-Q filed August 14,
2000)
|
10.4@
|
|
Interleukin
Genetics, Inc. 2004 Employee, Director and Consultant Stock Plan
(incorporated by reference to Exhibit 99.1 of the Company’s
Registration Statement No. 333-118551 on Form S-8 filed on
August 25, 2004)
|
Exhibit
No.
|
|
Identification
of Exhibit
|
10.5.1@*
|
|
Form
of Nonqualified Stock Option Agreement under the 2004 Employee, Director
and Consultant Stock Plan
|
10.5.2@*
|
|
Form
of Incentive Stock Option Agreement under the 2004 Employee, Director and
Consultant Stock Plan
|
|
|
|
|
|
Agreements with Executive Officers and
Directors
|
10.6@
|
|
Employment
Agreement dated November 12, 2008 between the Company and Kenneth S.
Kornman (incorporated by reference to Exhibit 10.4 of the Company’s
Quarterly Report on Form 10-Q filed on November 13,
2008)
|
10.7@
|
|
Employment
Agreement dated January 21, 2010 between the Company and Lewis H. Bender
(incorporated by reference to Exhibit 10.1 of the Company’s current Report
on Form 8-K filed on January 25, 2010)
|
10.8@
|
|
Employment
agreement dated April 30, 2008 between the Company and Eliot M. Lurier
(incorporated by reference to Exhibit 10.1 of the Company’s Quarterly
Report on Form 10-Q filed on August 13, 2008)
|
10.9@
|
|
Form
of Director Indemnity Agreement dated March 5, 2003 (incorporated
herein by reference to Exhibit 10.13 of the Company’s Current Report
on Form 8-K filed on March 5, 2003)
|
|
|
|
|
|
Agreements with respect to Financings and Rights
of Stockholders
|
10.10
|
|
Registration
Rights Agreement dated August 9, 2002 (incorporated herein by
reference to Exhibit 10.4 of the Company’s Quarterly Report on
Form 10-Q filed on November 7, 2002)
|
10.11
|
|
Security
Agreement between the Company and Pyxis Innovations Inc., dated
October 23, 2002 (incorporated herein by reference to Exhibit 10.2 of
the Company’s Current Report on Form 8-K filed on October 28,
2002)
|
10.11.1
|
|
Amendment
No. 2 to the Security Agreement between the Company and Pyxis
Innovations Inc., dated March 5, 2003 (incorporated herein by
reference to Exhibit 10.3 of the Company’s Current Report on
Form 8-K filed on March 5, 2003)
|
10.12
|
|
Registration
Rights Agreement between the Company and Pyxis Innovations Inc. dated
March 5, 2003 (incorporated herein by reference to Exhibit 10.8
of the Company’s Current Report on Form 8-K filed on March 5,
2003)
|
10.13
|
|
Stock
Purchase Agreement between the Company and Pyxis Innovations Inc.
dated March 5, 2003 (incorporated herein by reference to
Exhibit 10.1 of the Company’s Current Report on Form 8-K filed
on March 5, 2003)
|
10.13.1
|
|
Amendment
No. 1 to Stock Purchase Agreement between the Company and Pyxis
Innovations Inc. dated May 20, 2003 (incorporated by reference to
Exhibit 10.1 of the Company’s Current Report on Form 8-K filed
on May 30, 2003)
|
10.13.2
|
|
Second
Amendment to Stock Purchase Agreement between the Company and Pyxis
Innovations Inc. dated February 28, 2005 (incorporated by
reference to Exhibit 10.41 of the Company’s Annual Report on
Form 10-K filed on April 26, 2005)
|
10.14
|
|
Stock
Purchase Agreement Between the Company and Pyxis Innovations Inc.
dated August 17, 2006 (incorporated by reference to Exhibit 10.2
of the Company’s Current Report on Form 8-K/A filed on
October 31, 2006)
|
10.15
|
|
Form
of Promissory Note (incorporated by reference to Exhibit 10.4 of the
Company’s Current Report on Form 8-K/A filed on October 31,
2006)
|
10.16
|
|
Amended
and Restated Note Purchase Agreement between the Company and Pyxis
Innovations Inc. dated March 10, 2009 (incorporated by reference to
Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on
March 13, 2009)
|
10.16.1
|
|
First
Amendment, dated August 10, 2009, to Amended and Restated Note Purchase
Agreement dated March 10, 2009, by and between the Company and Pyxis
Innovations Inc. (incorporated by reference to Exhibit 10.1 of the
Company’s Quarterly Report on Form 10-Q filed on August 13,
2009)
|
10.16.2
|
|
Second
Amendment, dated February 1, 2010, to Amended and Restated Note Purchase
Agreement by and between the Company and Pyxis Innovations Inc.
(incorporated by reference to Exhibit 10.1 of the Company’s current Report
on Form 8-K filed on February 2, 2010)
|
|
|
|
|
|
Agreements with respect to Collaborations,
Licenses and Research and Development
|
10.17
|
|
Exclusive
License Agreement between the Company and Access Business Group dated
March 5, 2003 (incorporated herein by reference to Exhibit 10.7
of the Company’s Current Report on Form 8-K filed on March 5,
2003)
|
Exhibit
No.
|
|
Identification
of Exhibit
|
10.17.1
|
|
First
Amendment to License Agreement by and between the Company and Access
Business Group International, LLC, dated September 1, 2008 (incorporated
by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form
10-Q filed on November 13, 2008)
|
10.18
|
|
Purchase
Agreement between the Company and Access Business Group LLC dated
February 23, 2006 effective as of January 31, 2006 (incorporated
by reference to Exhibit 10.2 of the Company’s Quarterly Report on
Form 10-Q filed on May 10, 2006)
|
10.19
|
|
Purchase
Agreement between the Company and Access Business Group LLC dated
February 23, 2006 effective as of March 23, 2006 (incorporated
by reference to Exhibit 10.3 of the Company’s Quarterly Report on
Form 10-Q filed on May 10, 2006)
|
10.20
|
|
Research
Agreement by and between the Company and Access Business Group
International, LLC, dated February 25, 2008 (incorporated by reference to
Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q filed on May
15, 2008)
|
10.21+
|
|
Non-exclusive
License Agreement by and between the Company and OralDNA Labs, Inc., dated
August 12, 2008 (incorporated by reference to Exhibit 10.1 of the
Company’s Quarterly Report on Form 10-Q filed on November 13,
2008)
|
10.22+
|
|
Research
and License Agreement by and between the Company and Geisinger Health
System dated September 16, 2008 (incorporated by reference to Exhibit 10.3
of the Company’s Quarterly Report on Form 10-Q filed on November 13,
2008)
|
10.23*
|
|
Merchant
Network and Channel Partner Agreement dated October 26, 2009 by and
between the Company and Amway Corp.
|
|
|
|
|
|
Consents, Certifications and Other
Exhibits
|
21.1*
|
|
Subsidiaries
of the Company
|
23.1*
|
|
Consent
of Grant Thornton LLP
|
31.1*
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of Sarbanes-Oxley
Act of 2002
|
31.2*
|
|
Certification
of Principal Financial Officer pursuant to Section 302 of
Sarbanes-Oxley Act of 2002
|
32.1*
|
|
Certification
pursuant to Section 906 of Sarbanes-Oxley Act of
2002
|
+
|
The
Securities and Exchange Commission with respect to certain portions of
this exhibit has previously granted confidential treatment. Omitted
portions have been filed separately with the Securities and Exchange
Commission.
|
@
|
Management
contract or compensatory plan, contract or
arrangement.
|
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act
of 1934, the registrant caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
|
INTERLEUKIN
GENETICS, INC.
|
|
|
|
|
By:
|
/s/
Lewis H.
Bender
|
|
|
Lewis
H. Bender
Chief
Executive Officer
|
Date:
March 25, 2010
Pursuant
to the requirements of with the Securities Exchange Act of 1934, this report has
been signed below by the following persons on behalf of the registrant and in
the capacities and on the dates indicated below.
Signatures
|
|
Title
|
|
Date Signed
|
|
|
|
|
|
/s/
Lewis H.
Bender
|
|
Chief
Executive Officer, Director
|
|
March
25, 2010
|
Lewis
H. Bender
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
/s/
Eliot M.
Lurier
|
|
Chief
Financial Officer
|
|
March
25, 2010
|
Eliot
M. Lurier
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/
Kenneth S.
Kornman
|
|
President,
Chief Scientific Officer and Director
|
|
March
25, 2010
|
Kenneth
S. Kornman
|
|
|
|
|
|
|
|
|
|
/s/
James
Weaver
|
|
Chairman
of the Board of Directors
|
|
March
25, 2010
|
James
Weaver
|
|
|
|
|
|
|
|
|
|
/s/ Glenn S. Armstrong,
Ph.D.
|
|
Director
|
|
March
25, 2010
|
Glenn
S. Armstrong, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/
George
Calvert
|
|
Director
|
|
March
25, 2010
|
George
Calvert
|
|
|
|
|
|
|
|
|
|
/s/
Mary E.
Chowning
|
|
Director
|
|
March
25, 2010
|
Mary
E. Chowning
|
|
|
|
|
|
|
|
|
|
/s/
Thomas R. Curran
Jr.
|
|
Director
|
|
March
25, 2010
|
Thomas
R. Curran Jr.
|
|
|
|
|
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