Genelink, Inc - Recent Material Event
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ITEM 1. DESCRIPTION OF BUSINESS.
GENERAL
GeneLink, Inc. (GeneLink, the Company, we or us) is a publicly-held Pennsylvania corporation
listed on the NASDAQ OTC Bulletin Board trading under the symbol GNLK. We are a bioscience
company originally organized to offer to the public the safe collection and preservation of a
familys DNA material for later use by the family to identify and potentially prevent inherited
diseases. More recently we have created a breakthrough methodology for SNP (single nucleotide
polymorphism) based genetic profiling (patents issued and pending) and we intend to market and/or
license these proprietary assessments to companies that manufacture or market to the nutraceutical,
personal care, skin care and weight-loss industries.
We have never achieved a profit, having realized net losses each year, including operating losses
before extraordinary items of $1,281,157 in 2005, $790,868 in 2006
and $1,560,624 in 2007. There
can be no assurance that we will ever realize significant sales or become profitable.
We were founded in response to the explosion of information being generated in the field of human
molecular genetics. Scientists are discovering an increasing number of connections between genes
and specific diseases or physical attributes and tendencies. The growth of scientific knowledge in
this area has been accelerating as a direct result of the National Institutes of Health Genome
Project.
Our expansion into the bioscience field with our innovative genetic profiles help companies create
and deliver more effective products personalized wellness and quality of life products
tailored to their customers individual needs based on the science of genetics, thereby allowing
the consumer and/or their health care provider to determine what vitamin/nutritional supplements,
skin-care products, and health care or weight loss regimens are best for their individual needs.
We have developed proprietary SNP-based genetic profiles (named GeneLink Nutragenetic
ProfileTM and Dermagenetics® profiles). These profiles provide a means of predicting an
individuals inherent genetic capacity to combat such conditions as oxidative stress and other
important selected areas of physiologic health. The profiles, for example, can measure a persons
potential to efficiently control oxygen free radical damage, eliminate hydrogen peroxide, protect
and repair oxidized phospholipids and destroy harmful environmental compounds.
Our profile assessment enables nutritional and skin care companies and health care professionals to
recommend a specific and targeted regime of antioxidant vitamins, nutrients or skin care
formulations that have been specifically designed to compensate for predicted deficiencies and to
help provide individuals the best of health and appearance.
In 2004, we formed a wholly owned subsidiary, Dermagenetics, Inc., to provide our genetically
customized products and services to the skin and personal care market. In 2007, we formed a wholly
owned subsidiary, GeneWize Life Sciences, Inc., to provide our genetically customized products and
services to the nutrition market. GeneWize intends to formally launch its service offerings in the
third quarter of 2008.
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Oxidative Stress Profiles
The Oxidative Stress (OS) Profile (US patent pending, Australian patent issued) provides a means of
predicting an individuals inherent genetic capacity to combat oxidative stress. The profile can
measure a persons potential to efficiently control oxygen free radical damage, eliminate hydrogen
peroxide, protect and repair oxidized phospholipids and destroy harmful environmental compounds.
This profile information will enable nutritional and skin care companies to recommend a specific
and targeted regime of antioxidant vitamins, nutrients or skin-care formulations that have been
specifically designed to compensate for predicted deficiencies. Thus, the OS profile can be used
to make rational choices to help optimize nutritional and skin care needs to provide the best of
health and appearance.
The profile examines genes of the OS family for the existence of SNPs (naturally occurring
variations in genes) that can result in an amino acid substitution in the protein that is encoded
by that gene. If such a protein is an OS enzyme, it may be less efficient in enzymatic activity,
in which case oxidative damage to cellular proteins and DNA accumulates over time. It appears that
some tissues are more vulnerable than are others to oxidative stress. SNPs in other oxidative
stress genes have been associated with heart disease, cancer, neurological degeneration and aging.
A search for SNPs has the advantage of identifying genetic variations that reduce an individuals
antioxidant defense capacity. It can detect changes that are life-long and predicted to
chronically affect the ability to defend against oxidative stress, aging and age related disease.
Genetic profiling information based on SNPs analyses can be used to design appropriate antioxidant
vitamin, nutrient and skin-care formulations that are specifically tailored to each individual.
Oxidative Stress for Skin Health and Skin Aging Profile
By simply swabbing the inside of ones mouth and sending the collected sample to our laboratory, an
individual can have a skin or personal care formulation specifically designed to compensate for
associated deficiencies.
Currently, when a person sees wrinkles or lines, he or she may begin to apply a variety of products
and creams that contain antioxidants such as retinoids. This approach is only partially effective
because it typically begins only after the signs of aging have appeared. A superior strategy is to
predict certain causes of the aging of the skin and initiate a therapy that is designed to match
the individuals genetic pattern and genetic risk of skin aging. For example, individuals with
moderate or high risk of oxidative stress could be encouraged to initiate a therapy much earlier
even before outward signs of skin aging.
Our Skin Health test for skin aging looks for SNPs in several key genes that are associated with
oxidative stress, skin irritation, photo aging and an individuals ability to naturally defend
against environmental stresses. Skin health test results can be used to guide consumers to skin
therapies or skin products containing unique active ingredients (SNPActives) and formulations
designed to help alleviate specific oxidative stresses and other potential deficiencies in the
skin.
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Other SNP Profiles Developed by the Company
We have also developed a Cardiovascular Risk Profile and an Osteopenia Susceptibility Profile.
Cardiovascular disease claims more lives each year than the next five leading causes of death
combined. We have recently developed a Cardiovascular Risk Profile, that analyzes a broad
collection of genes believes to play an important part in heart health, according to the latest
research. Our Cardiovascular Risk Profile is designed to identify SNPs associated with increased
risk of developing high blood pressure, atherosclerosis, inflammation, problems with vascular
integrity and coronary artery disease.
Osteopenia is a condition that often leads to osteoporosis, a disease characterized by low bone
density. Osteoporosis is responsible for 1.5 million fractures each year (including fractures of
the vertebrae, forearms, wrists and hips). According to the National Osteoporosis Foundation, 1 in
3 women and at least 1 in 12 men will develop osteoporosis during their lifetime. Our Osteopenia
gene test looks for SNPs in several key genes that are associated with bone density. Since
osteoporosis can develop undetected for decades, this test may be a tool to help determine the
future risk for fractures and related clinical conditions such as spinal column compression and
bone breaks with or without falls and guide early interventions or therapies that help combat or
prevent the condition.
We have developed a NQ01 SNP profile. NQ01 is a protein that contributes to the recharging
Coenzyme Q10. Coenzyme Q10 is a natural compound made by the human body that helps cells produce
energy and protect against free radicals that can damage DNA and other molecules of the cell. The
NQ01 assessment is complete, ready to market and a provisional patent has been filed. We have also
developed a DNA Integrity and Repair Panel which is complete and ready to market. We have
developed an Alzheimer/Dementia Panel that requires some additional clinical validation.
Proposed Direct Selling/MLM Marketing Channel
We expect to launch GeneWize Life Sciences in the third quarter of 2008. GeneWize Life Sciences
is a wholly owned subsidiary that will be a specialized health, beauty and wellness company that
markets to consumers by developing a network of affiliates and customers. This type of marketing is
commonly called referral marketing or Direct Selling/MLM marketing. The Direct Selling/MLM
channel typically supports and welcomes new technologies; its top product sales categories are
nutritional products followed by skin care products. The industry as a whole is in an eight-year
growth trend of about 5% annually. Worldwide industry sales are approaching $100 billion and U.S.
sales in 2005 were approximately $30.5 billion. In the Direct Selling/MLM marketing model,
affiliate/distributors pay the company a small fee for the right to market products and are paid
commissions only after sales are made. We believe that there is potential for success in this
channel in part due to the high differentiation of its genetically guided (customized) nutrition
and skin care versus one-size-fits-all nutrition and skin-care products.
We have engaged a nationally recognized Direct Selling/MLM advisory group that specializes in
developing and executing start-up and ongoing business strategies specifically for companies in
this marketing channel. To help recruit affiliates/distributors, we intend to engage an experienced
sales and marketing director and 3 or 4 support staff for marketing and management. We also expect
to engage a nationally recognized Direct Selling/MLM branding and positioning agency that can
assist us to develop media, marketing and branding strategies for this channel. Product
manufacturing,
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shipping and distributor kit fulfillment will be outsourced.
There is no guarantee that we will be able to meet the proposed timeline discussed above, that we
will be successful in this marketing channel or that we will be able to attract a sufficient number
of affiliate/distributors and/or customers.
Dermagenetics
We formed a subsidiary known as Dermagenetics, Inc. which has created and is distributing DNA
UltraCustom skin cream, genetically designed to an individuals needs, specifically to the spa
industry. Currently, Dermagenetic is not actively marketing to the spa industry.
DNA Banking
We have ceased actively marketing DNA banking, wherein specimens can be collected during an
individuals lifetime or up to 36 to 40 hours after death using our DNA Collection Kit® for
long-term storage at the University of North Texas Health Science Center (the Health Science
Center). The Health Science Center will continue to store the DNA specimen for a 75 year period,
for all existing clients who have sent in DNA for banking. Upon a clients request, and upon the
payment of a retrieval fee, the stored DNA specimen can be retrieved and sent to a laboratory for
testing. The Health Science Center is no longer obligated to receive and store any additional DNA
specimens.
Affiliates and Licensing and Distribution Partners
We have entered into agreements with several laboratories pursuant to which these laboratories
perform SNP genotyping of samples provided by us for any genetics-based products that we may
develop.
In December 2007, we entered into a license and distribution agreement with Solgar Vitamin and
Herb, pursuant to which Solgar will manufacture, market and distribute a line of premium
genetically guided dietary supplements utilizing the Companys Nutritional System to Solgars
health food and specialty natural food retailers North America.
In June 2007, we entered into a license and distribution agreement with PhytoRich, LLC, pursuant to
which PhytoRich will distribute our nutritional care and skin care systems to its medical
practitioner customers.
In February 2006, we entered into a distribution agreement with Rejuvenation Plus Pty Ltd, an
international skincare and cosmetics company, pursuant to which that company has been granted the
exclusive right to distribute products based upon our technology in Australia and New Zealand.
We have a Distribution Agreement with Food Science Corporation to develop and market personalized
nutritional products linked to our genetic profiling technology. Food Science has been a leader in
nutritional research by setting new standards of quality in the formulation of nutritional
supplements created exclusively for health care professionals and their patients. Food Science
focuses on innovation and product effectiveness and serves a loyal client base of over 12,000
medical doctors, chiropractors, osteopaths and nutritionists.
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Intellectual Property
On May 1, 2007, we received a U.S. patent for our proprietary method for assessing skin health in
humans. We have filed a series of U.S. patent applications relating to the our DNA Collection Kit®
and methods for assessing a human subjects susceptibility to various medical conditions, including
skin health, oxidative damage, osteoporosis and other bone density disorders and obesity and for
methods of selecting and measuring the dosage of preventative agents for such conditions. There
can be no assurance that we will receive patent protection on our methods or procedures. We are
negotiating licensing these proprietary assessments to companies that manufacture or market to the
$100 billion plus nutraceutical, personal care, skin care, and weight-loss industries.
We believe that our gene profiles offer marketing companies the information they need to create and
sell more effective products tailored to their customers individual needs based on the science
of genetics. By simply swabbing the inside of ones mouth (using our patented DNA Collection Kit®)
and sending the collected sample to our laboratories consumers can be directed to personalized
products specifically formulated to help compensate for their predicted deficiencies.
We have received Australian Patent #2002230953 Kits and Methods for Assessing Oxidative Stress;
Trademark: Dermagenetics #78398892 and 78398898 (for the Dermagenetics face design) and #78412723
for SNP Actives.
We have also developed and received a patent (Patent #6,291,171) on a non-invasive DNA Collection
Kit® for the collection of DNA specimens of clients. No licensing or training is necessary for the
collection by a client of his or her DNA specimen. The DNA Collection Kit® consists of several
swabs, collection accessories, complete instructions and a mailing envelope; the kit and kit
elements are bar coded to facilitate tracking, control and confidentiality. The collection process
is self administered and non-invasive (the DNA specimen is obtained by swabbing the inside of the
cheek) and takes less than five minutes to complete. The kit is classified as a non-medical
device. There is no assurance that the patent will prevent others from gathering DNA in a similar
manner.
We have
received trademark protection for our name and logo and for the name DNA Collection Kit®.
Competition
Our potential competitors in the United States and abroad in the field of personalized nutrition
and skin care are numerous and include, among others, major pharmaceutical and diagnostic
companies, specialized biotechnology firms, universities and other research institutions. Many of
our potential competitors have considerably greater financial technical, marketing and other
resources than we do, which may allow these competitors to discover important genes or successfully
commercialize these discoveries before we could.
The business of manufacturing, distributing and marketing nutritional supplements and personalized
skin care and skin health products is highly competitive. Many of our competitors are
substantially larger and have greater financial resources with which to manufacturer and market
their products. The barriers to competition are low in these markets because the products are
generally not protected
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by patents. Our ability to remain competitive depends on the successful introduction, marketing,
promotion, and addition of new offerings to our product line.
Government Regulations
Pursuant to a letter dated January 23, 1996, the Food and Drug Administration has determined that
our kit is a device, but is not subject to active regulations by the Center for Devices and
Radiological Health. However, any change in the current regulations could result in the kit
becoming a regulated device.
Employees and Labor Relations
We consider our labor relations to be good, and none of our employees is covered by a collective
bargaining agreement. As of March 1, 2008, we employed or engaged individuals in the following
areas:
Scientific Advisory Board
Our Scientific Advisory Board consists of Dr. Robert P. Ricciardi, Dr. Bernard L. Kasten, Dr. Harry
Harrison, Dr. James Simpkins, Dr. Donald Cannon, Dr. Robert P.K. Keller and Dr. Robert L. Kagan.
Dr. Ricciardi and Dr. Kasten are members of our Board of Directors.
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RISK FACTORS
Our business and the value of our shares are subject to the risks described above and certain
additional risks described below.
IF OUR FORMER CHIEF EXECUTIVE OFFICER PREVAILS WITH RESPECT TO HIS LITIGATION AGAINST US, WE MAY
NOT BE ABLE TO PAY ANY JUDGMENT AND COULD BE FORCED TO CEASE OUR OPERATIONS.
On October 14, 2005, we terminated the employment of John R. DePhillipo, our former Chief Executive
Officer and President. In November 2005, Mr. DePhillipo brought suit against us alleging, among
other things, that he was terminated without cause, that we breached the terms of his employment
agreement and that he is entitled to receive $84,000 of back salary and at least $1,500,000 of
salary throughout the remainder of the term set forth in such employment agreement. We have denied
such allegations and have brought counterclaims against Mr. DePhillipo alleging that Mr. DePhillipo
was terminated for cause, that Mr. DePhillipo breached his fiduciary duty to us and alleging
breach of fiduciary duty, conversion, negligent misrepresentation, unjust enrichment and fraud.
The trial is currently scheduled to commence April 14, 2008. If Mr. DePhillipo prevails in this
litigation and obtains a judgment against us for all or any substantial portion his claim, it is
likely that we will not be able to pay any such judgment and may be forced to cease operations. As
all of our assets have been pledged to our secured creditors, it is unlikely that our shareholders
would receive any distributions if we were forced to cease its operations and liquidate in the
event of Mr. DePhillipo prevailing in the litigation.
IF WE DEFAULT ON OUR OBLIGATIONS WITH RESPECT TO OUR SECURED OR UNSECURED DEBT, OUR LENDERS AND
CREDITORS COULD FORECLOSE UPON OUR ASSETS.
In 2006 and 2007, we entered into a series of secured convertible loan financings pursuant to which
we have pledged all of our assets as collateral for the repayment of the secured convertible loan
obligations. The secured convertible loan obligations mature on May 12, 2011. As of December 31,
2007, $728,812 of principal and interest were outstanding on the secured convertible loans. These
notes were convertible into 14,576,240 shares of our Common Stock as of December 31, 2007. If the
conditions to converting these loans are not met, it is unlikely that we would be able to repay
these loans without refinancing, extending, modifying or converting such obligations. If we are
unable to repay our obligations with respect to such loans or to refinance, extend, modify or
convert such loans, the Lenders would be entitled to foreclose against such collateral, and in such
event we would be required to cease operations.
Additionally, we owed $583,567 of accounts payable and accrued expenses as of December 31, 2007.
If we are unable to generate sufficient revenues or raise sufficient funds to meet these
obligations as they become due, we may default upon these obligations and may be required to cease
our operations.
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WE NEED TO RAISE ADDITIONAL CAPITAL, WHICH MAY NOT BE AVAILABLE, TO CONTINUE OUR OPERATIONS.
We have spent, and expect to continue to spend in the future, substantial funds to complete our
planned product development efforts and expand our sales and marketing activities. We need to
raise additional funds to implement our business plan, and cannot be certain that we will be able
to obtain additional financing on favorable terms or at all.
Our future capital requirements and the adequacy of available funds will depend on numerous
factors, including:
If funds generated from our operations are insufficient to meet current or planned operating
requirements, we will have to obtain additional funds through equity or debt financing, strategic
alliances with corporate partners and others, or through other sources. We do not have any
committed sources of additional financing, and cannot provide assurance that additional funding, if
necessary, will be available on acceptable terms, if at all. If adequate funds are not available,
we may have to delay, scale-back or eliminate certain aspects of its operations or attempt to
obtain funds through arrangements with collaborative partners or others. This may result in the
relinquishment of our rights to certain of our technologies, product candidates, products or
potential markets. Therefore, the inability to obtain adequate funds could have a material adverse
impact on our business, financial condition, and results of operations and our ability to remain in
business.
WE HAVE A HISTORY OF LOSSES AND EXPECT CONTINUED LOSSES FOR THE FORESEEABLE FUTURE.
We commenced operations in 1994. We have incurred significant losses to date and revenues have
been limited. Our expenses have exceeded revenues in each year since inception. Given planned
levels of operating expenses, we expect to continue to incur losses for the foreseeable future.
Our accumulated deficit as of December 31, 2007 was $12,681,698. Our expenses have consisted
principally of research and development, salaries and for general and administrative expenses
incurred while building its business infrastructure. We expect to continue to experience
significant operating losses in the future as we continue our research and development efforts and
expand our marketing and sales force in an effort to commercialize our products and services. We
plan to increase operating expenses in anticipation of increasing revenues. If our revenue growth
is slower than anticipated or operating expenses exceed expectations, our losses will significantly
increase. Even if we were to achieve profitability, it may not be able to sustain or increase
profitability on a quarterly or annual basis.
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OUR BUSINESS CURRENTLY DEPENDS PRIMARILY ON THE SUCCESS OF OUR LICENSING PROGRAM, WHICH IF
UNSUCCESSFUL, WILL THREATEN OUR SURVIVAL.
A principal element of our current business strategy is to enter into licensing arrangements
with companies to manufacture products incorporating our technologies. We do not currently
distribute or sell our products, although we do intend to do so in the foreseeable future. Thus,
our current prospects are substantially dependent on the receipt of royalties from licensees of our
technologies. We face challenges in entering into new license agreements. During discussions with
potential licenses, significant negotiation issues arise from time to time. We can not be assured
that prospective licensees will be persuaded during negotiations to enter into a license agreement
with us, either at all or on terms acceptable to us.
The royalties we receive from licensees depend on their efforts and expenditures over which we
have no control. Because it is up to our licensees to decide when and if they will introduce
products using our technology, we cannot predict when and if our licensees will generate
substantial sales of such products. The amount and timing of royalty payments are dependent on the
ability of our licensees to gain successful regulatory approval for, market and sell products
incorporating our technologies. Failure of certain licensees to gain regulatory approval, if
required, or market acceptance for such products could have a material adverse effect on our
business, financial condition and results of operations.
If one or more of our licensees fail to pursue the development or marketing of these products
as planned, our revenue and profits would be adversely affected. We do not control the timing and
other aspects of the development or commercialization of products incorporating our licensed
technologies because our licensees may have priorities that differ from ours or their development
or marketing efforts may be unsuccessful, resulting in delayed or discontinued products. Hence,
the amount and timing of royalty payments received by us will fluctuate, and such fluctuations
could have a material adverse effect on our business, financial condition and results of
operations.
WE HAVE A SIGNIFICANT NUMBER OF SECURITIES OUTSTANDING THAT ARE CONVERTIBLE INTO OUR COMMON STOCK,
AND THE CONVERSION OF THESE SECURITIES COULD RESULT IN SUBSTANTIAL DILUTION TO EXISTING
STOCKHOLDERS.
We have issued convertible secured promissory notes that are convertible into shares of our
common stock at $0.05 per share, which conversion prices could be substantially less than the
market price of our common stock at the time of conversion. The issuance of stock at a price that
is less than the market price could have an immediate adverse effect on the market price of our
common stock. In addition, we have issued options and warrants to acquire shares of our common
stock. See Note 10 to our audited financial statements included in this report for more
information regarding the convertible secured promissory notes, options and warrants. We may issue
additional convertible notes or warrants in connection with financing arrangements and may grant
additional stock options that may further dilute our common stock. The exercise of such securities
would have a dilutive effect on our common stock. Also, to the extent that shareholders
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who acquire shares of our common stock under all the foregoing agreements sell those shares in the
open market, the price of our shares may decrease due to additional shares in the market.
OUR COMMON STOCK PRICE IS VOLATILE AND WE HAVE A THIN TRADING MARKET.
Although the our Common Stock is listed on the NASDAQ OTC Bulletin Board, recently daily trading
volume of our Common Stock has generally been limited. The prices for securities of biosciences
companies have historically been volatile. The trading price of our Common Stock has experienced
considerable fluctuation since we began public trading in 1998.
WE EXPECT FUTURE DILUTION TO SHAREHOLDERS AND INVESTORS.
We believe it is likely that we will be required to raise additional amounts to fund future
operations. If additional funds are raised through issuing equity securities or debt securities
convertible into equity, dilution to shareholders may occur.
OUR LIMITED OPERATING HISTORY AND RECENT CHANGE IN MARKETING STRATEGY MAKE IT DIFFICULT TO EVALUATE
OUR PROSPECTS.
We have a limited operating history on which to evaluate our business and prospects. We are in the
process of rebranding and repositioning our company and creating a network of independent
distributors. There is no assurance that we will achieve significant sales as a result of this new
strategy. We also may not be successful in addressing our operating challenges such as establishing
a viable network of independent distributors, developing brand awareness and expanding our market
presence. Our prospects for profitability must be considered in light of our evolving business
model. These factors make it difficult to assess our prospects.
IF ETHICAL AND OTHER CONCERNS SURROUNDING THE USE OF GENETIC INFORMATION BECOME WIDESPREAD, WE MAY
HAVE LESS DEMAND FOR THE OUR PRODUCTS.
Genetic testing has raised ethical issues regarding confidentiality and the appropriate uses of the
resulting information. For these reasons, governmental authorities may call for limits on or
regulation of the use of genetic testing or prohibit testing for genetic predisposition to certain
conditions, particularly for those that have no known cure. Any of these scenarios could reduce
the potential markets for our services and products.
DUE TO THE HIGH LEVEL OF COMPETITION IN OUR INDUSTRY, WE MIGHT FAIL TO RETAIN OUR CUSTOMERS AND
DISTRIBUTORS, WHICH WOULD HARM OUR FINANCIAL CONDITION AND OPERATING RESULTS.
The business of marketing skin care and nutrition products is highly competitive and sensitive to
the introduction of new products which may rapidly capture a significant share of the market. These
market segments include numerous manufacturers, distributors, marketers, retailers and physicians
that actively compete for the business of consumers both in the United States and abroad. In
addition, we anticipate that we will be subject to increasing competition in the future from
sellers that utilize electronic commerce. Many of these competitors have longer operating
histories, significantly
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greater financial, technical, product development, marketing and sales resources, greater name
recognition, larger established customer bases and better-developed distribution channels than we
do. Our present or future competitors may be able to develop products that are comparable or
superior to those we offer, adapt more quickly than we do to new technologies, evolving industry
trends and standards or customer requirements, or devote greater resources to the development,
promotion and sale of their products than we do. For example, if our competitors develop skin care
or nutritional treatments that prove to be more effective than our products, demand for our
products could be reduced. Accordingly, we may not be able to compete effectively in our markets
and competition may intensify. We are also subject to significant competition for the recruitment
of distributors from other network marketing organizations, including those that market nutritional
supplements and skin care products as well as other types of products. Our ability to be
competitive therefore will depend, in significant part, on our success in recruiting and retaining
distributors through an attractive compensation plan, the maintenance of an attractive product
portfolio and other incentives. We cannot ensure that our programs for recruitment and retention of
distributors will be successful, and if they are not, our financial condition and operating results
would be harmed.
THE MARKET FOR OUR PRODUCTS AND SERVICES IS UNPROVEN.
The market for our products and services is at an early state of development and may not continue
to grow. The general scientific community has only a limited understanding of the role of genes in
predicting disease. The marketplace may never accept our products and services, and we may never
be able to sell our products and services at a profit. Our efforts to commercialize our
intellectual property have had limited success to date. We can achieve broad market acceptance
only with substantial education about the benefits and limitations of our products and services.
NEW PRODUCTS MAY RENDER OUR PRODUCTS OBSOLETE AND OUR SALES MAY SUFFER.
The skin care and nutritional supplement markets historically have been influenced by fad
products that became popular due to changing consumer tastes and media attention. Our products may
be rendered obsolete by changes in popular tastes as well as media attention on new products or
adverse media attention on skin care and nutritional supplements, which could reduce our sales. It
may be difficult for us to change our product line to adapt to changing tastes. In addition, other
fad food regimens, such as low carbohydrate diets, may decrease the overall popularity and use of
our products, as well as result in higher returns of our products, thereby increasing our expenses.
THE SALE OF OUR PRODUCTS INVOLVES PRODUCT LIABILITY AND RELATED RISKS THAT COULD EXPOSE US TO
SIGNIFICANT INSURANCE AND LOSS EXPENSES.
We face an inherent risk of exposure to product liability claims if the use of our products results
in, or is believed to have resulted in, illness or injury. Most of our products contain
combinations of ingredients, and there is little long-term experience with the effect of these
combinations. In addition, interactions of these products with other products, prescription
medicines and over-the-counter drugs have not been fully explored or understood and may have
unintended consequences. While our third party manufacturers perform tests in connection with the
formulations of our products, these tests are not designed to evaluate the inherent safety of our
products.
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Although we maintain product liability insurance, it may not be sufficient to cover product
liability claims and such claims could have a material adverse effect on our business. The
successful assertion or settlement of an uninsured claim, a significant number of insured claims or
a claim exceeding the limits of our insurance coverage would harm us by adding further costs to our
business and by diverting the attention of our senior management from the operation of our
business. Even if we successfully defend a liability claim, the uninsured litigation costs and
adverse publicity may be harmful to our business.
Any product liability claim may increase our costs, and adversely affect our revenues and operating
income. Moreover, liability claims arising from a serious adverse event may increase our costs
through higher insurance premiums and deductibles, and may make it more difficult to secure
adequate insurance coverage in the future. In addition, our product liability insurance may fail to
cover future product liability claims, which if adversely determined could subject us to
substantial monetary damages.
WE ARE DEPENDENT ON A LIMITED NUMBER OF INDEPENDENT SUPPLIERS, LABORATORIES AND MANUFACTURERS OF
OUR PRODUCTS.
We rely entirely on a limited number of third parties to supply and manufacture our products and to
perform laboratory tests on our behalf. Our manufacturers produce our products on a purchase order
basis only and can terminate their relationships with us at will. These third parties may be unable
to satisfy our supply requirements, manufacture our products on a timely basis, fill and ship our
orders promptly, provide services at competitive costs or offer reliable products and services. The
failure to meet of any of these critical needs would delay or reduce product shipment and adversely
affect our revenues, as well as jeopardize our relationships with our independent distributors and
customers. In the event any of our third party manufacturers were to become unable or unwilling to
continue to provide us with products in required volumes and at suitable quality levels, we would
be required to identify and obtain acceptable replacement manufacturing sources. There is no
assurance that we would be able to obtain alternative manufacturing sources on a timely basis. An
extended interruption in the supply of our products would result in decreased product sales and our
revenues would likely decline. We believe that we can meet our current supply and manufacturing
requirements with our current suppliers and manufacturers or with available substitute suppliers
and manufacturers.
While we require that our manufacturers verify the accuracy of the contents of our products, we do
not have the expertise or personnel to monitor the production of products by these third parties.
We rely exclusively, without independent verification, on certificates of analysis regarding
product content provided by our third party suppliers and limited safety testing by them. We cannot
be assured that these outside manufacturers will continue to supply products to us reliably in the
compositions we require. Errors in the manufacture of our products could result in product recalls,
significant legal exposure, adverse publicity, decreased revenues, and loss of distributors and
endorsers.
WE ARE DEPENDENT ON KEY PERSONNEL.
Our success will depend in large part upon the continued services of a number of key employees and
consultants. The loss of the services of any of these individuals could have a material adverse
effect on us. In addition, if one or more of our key employees or consultants leaves to join a
competitor or to form a competing company, the loss of such personnel and any resulting loss of
existing or potential clients to any such competitor could have a material adverse effect on our
business,
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financial condition and results of operations. In the event of the loss of any such personnel,
there can be no assurance that we would be able to prevent the unauthorized disclosure or use of
our technical knowledge, practices or procedures by such personnel.
OUR BUSINESS COULD BE ADVERSELY AFFECTED IF WE ARE UNABLE TO PROTECT OUR PROPRIETARY TECHNOLOGY OR
SOMEONE CLAIMS THAT WE ARE INFRINGING ON THEIR PROPRIETARY TECHNOLOGY.
Our success depends, in part, upon our proprietary methodologies and other intellectual property
rights. There can be no assurance that the steps taken by us to protect our proprietary
information will be adequate to deter misappropriation of our proprietary information or that we
will be able to detect unauthorized use and take appropriate steps to enforce our intellectual
property rights. In addition, although we believe that our services and products do not infringe
on the intellectual property rights of others, there can be no assurance that such a claim will not
be asserted against us in the future, or that if asserted any such claim will be successfully
defended. A successful claim against us could materially and adversely affect our business,
financial condition and results of operations.
Our success will depend on our ability to obtain and protect patents on our technology and to
protect our trade secrets. Our patents, which have been or may be issued, may not afford
meaningful protection for our technology and products. Others may challenge our patents and, as a
result, our patents could be narrowed, invalidated or unenforceable. In addition, the our current
and future patent applications may not result in the issue of patents in the United States or
foreign countries. Competitors may develop products similar to our products that do not conflict
with our patents. In order to protect or enforce our patent rights, we may initiate patent
litigation against third parties, such as infringement suits or interference proceedings. These
lawsuits could be expensive, take significant time and divert managements attention from other
business concerns. We may also provoke third parties to assert claims against us.
We have received notice of an alleged patent infringement from an Australian bioscience company,
Genetic Technologies Limited (GTG), that it has certain rights under filed patents to which we may
be infringing upon. Although it is the opinion of our patent counsel that there is no
infringement, and that in the event there is an infringement, it will not effect our business
because GTGs patents are not material to our technology, no assurance can be given that GTG would
not prevail if it brings legal action against us or that the result of any such action would not
have a material adverse effect on our business and prospects.
INTERRUPTIONS TO OR FAILURE OF OUR INFORMATION PROCESSING SYSTEMS MAY DISRUPT OUR BUSINESS AND OUR
SALES MAY SUFFER.
We are dependent on our information processing systems to timely process customer orders, oversee
and manage our distributor network and control our inventory, and for our distributors to
communicate with their customers and distributors in their network. Interruptions to or failure of
our information processing systems may be costly to fix and may damage our relationships with our
customers and distributors, and cause us to lose customers and distributors. If we are unable to
fix problems with our information processing systems in a timely manner our sales may suffer.
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IN CONNECTION WITH THE PROPOSED DIRECT SALES BUSINESS OF OUR SUBSIDIARY, THE FAILURE TO RECRUIT,
MAINTAIN AND MOTIVATE A LARGE BASE OF PRODUCTIVE INDEPENDENT DISTRIBUTORS COULD LIMIT ITS ABILITY
TO GENERATE REVENUES.
We anticipate entering into the direct sales business through a newly formed subsidiary, GeneWize
Life Sciences, Inc. To derive revenues, GeneWize will have to recruit and engage independent
distributors. We cannot assure you that GeneWize will be successful in recruiting and retaining
productive independent distributors, particularly since direct sales organizations usually
experience high turnover rates of independent distributors. Typically, independent distributors can
terminate their relationships at any time.
In recruiting and keeping independent distributors, GeneWize will be subject to significant
competition from other direct sales organizations, both inside and outside its industry. Its
ability to attract and retain independent distributors will be dependent on the attractiveness of
its compensation plan, its product mix, and the support it offers to its independent distributors.
Adverse publicity concerning direct sales marketing and public perception of direct selling
businesses generally could negatively affect GeneWizes ability to attract, motivate and retain
independent distributors.
Based on our knowledge of the direct selling industry, we anticipate that GeneWizes independent
distributor organization will be headed by a relatively small number of key independent
distributors who together with their downline network will be responsible for a disproportionate
amount of revenues. We believe this structure is typical in the direct selling industry, as sales
leaders emerge in these organizations. The loss of key independent distributors could adversely
affect GeneWizes revenues and could adversely affect GeneWizes ability to attract other
independent distributors.
GENEWIZE MAY BECOME AFFECTED BY LAWS, GOVERNMENTAL REGULATIONS, ADMINISTRATIVE DETERMINATIONS,
COURT DECISIONS AND SIMILAR CONSTRAINTS WHICH COULD MAKE COMPLIANCE COSTLY AND SUBJECT GENEWIZE TO
ENFORCEMENT ACTIONS BY GOVERNMENTAL AGENCIES.
The formulation, manufacturing, packaging, labeling, holding, storage, distribution, advertising
and sale of nutritional and skin care products are affected by extensive laws, governmental
regulations and policies, administrative determinations, court decisions and similar constraints at
the federal, state and local levels. There can be no assurance that GeneWize or its independent
distributors will be in compliance with all of these regulations. A failure by GeneWize or its
distributors to comply with these laws and regulations could lead to governmental investigations,
civil and criminal prosecutions, administrative hearings and court proceedings, civil and criminal
penalties, injunctions against product sales or advertising, civil and criminal liability for
GeneWize bad publicity, and tort claims arising out of governmental or judicial findings of fact or
conclusions of law adverse to GeneWize. In addition, the adoption of new regulations and policies
or changes in the interpretations of existing regulations and policies may result in significant
new compliance costs or discontinuation of product sales and may adversely affect the marketing of
our products, resulting in decreases in revenues.
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GeneWizes marketing program will be subject to laws and regulations applicable to direct selling
marketing organizations. These laws and regulations generally are directed at preventing fraudulent
or deceptive schemes, often referred to as pyramid or chain sales schemes, by ensuring that
product sales ultimately are made to consumers and that advancement within an organization is based
on sales of the organizations products rather than investments in the organization or other
non-retail sales-related criteria. The regulations concerning these types of marketing programs do
not include bright line rules and are inherently fact-based.
GeneWize may also be subject to the risk of private party challenges to the legality of its direct
selling program. Direct selling programs of some other companies have been successfully challenged
in the past. The challenges centered on whether the marketing programs of direct selling companies
are investment contracts in violation of applicable securities laws and pyramid schemes in
violation of applicable FTC rules and regulations.
In 2003, the FDA proposed a new regulation to require current Good Manufacturing Practice
guidelines (cGMPs) in the manufacture, packing, holding, and distribution of nutritional
supplements. The proposed rules would establish minimum standards that must be met by all companies
that manufacture, package, and hold nutritional supplements in the United States. Violation of
those standards would render the products in question presumptively adulterated and unlawful to
sell. The proposed cGMPs would require manufacturers to follow procedures that would track
nutrients from source to finished product, test nutrients for identity, purity, quality, strength,
and composition at each stage of production, and record full compliance with specific regulations
governing production, manufacture, and holding of nutritional supplements. We expect that the cGMPs
will increase GeneWizes product costs by requiring its various contract manufacturers to expend
additional capital and resources on quality control testing, new personnel, plant redesign, new
equipment, facilities placement, recordkeeping and ingredient and product testing. The FDA and
some state agencies invite the public to complain if they experience any adverse effects from the
consumption of nutritional supplements. These complaints may be made public. Regardless of whether
complaints of this kind are substantiated or proven, public release of complaints of this type may
have an adverse effect upon public perception of GeneWize, the quality of GeneWizes products or
the prudence of taking GeneWizes products. Changes in consumer attitudes based on adverse event
reports could adversely affect the potential market for and sales of GeneWizes products and make
it more difficult to recruit and retain independent distributors and obtain endorsers.
ADVERSE PUBLICITY ASSOCIATED WITH GENEWIZES PRODUCTS, INGREDIENTS OR NETWORK MARKETING PROGRAM, OR
THOSE OF SIMILAR COMPANIES, COULD HARM GENEWIZES FINANCIAL CONDITION AND OPERATING RESULTS.
Adverse publicity concerning any actual or purported failure of GeneWize or its independent
distributors to comply with applicable laws and regulations regarding product claims and
advertising, good manufacturing practices, the regulation of its network marketing program, the
licensing of GeneWize s products for sale in its target markets or other aspects of its business,
whether or not resulting in enforcement actions or the imposition of penalties, could have an
adverse effect on the goodwill of GeneWize and could negatively affect its ability to attract,
motivate and retain distributors, which would negatively impact its ability to generate revenue.
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We cannot ensure that all distributors will comply with applicable legal requirements relating to
the advertising, labeling, licensing or distribution of its products.
WE ARE SUBJECT TO, AMONG OTHER THINGS, REQUIREMENTS REGARDING THE EFFECTIVENESS OF INTERNAL CONTROL
OVER FINANCIAL REPORTING AND OUR FAILURE TO IDENTIFY OR CORRECT DEFICIENCIES AND AREAS OF WEAKNESS
IN THE COURSE OF THESE AUDITS COULD ADVERSELY AFFECT OUR FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
We are required to comply with various corporate governance and financial reporting requirements
under the Sarbanes-Oxley Act of 2002, as well as new rules and regulations adopted by the
Securities and Exchange Commission and the Public Company Accounting Oversight Board. We expect to
spend significant amounts of time and money on compliance with these rules. Our failure to correct
any noted weaknesses in internal controls over financial reporting could result in the disclosure
of material weaknesses which could have a material adverse effect upon the market value of our
stock. On an on-going basis, we conduct internal audits of various aspects of our business and
operations. These internal audits are conducted to ensure compliance with our policies and to
strengthen our operations and related internal controls. There can be no assurance that these
internal audits will uncover all material deficiencies or areas of weakness in our operations or
internal controls. If left undetected and uncorrected, such deficiencies and weaknesses could have
a material adverse effect on our financial condition and results of operations.
OUR ARTICLES OF INCORPORATION AND BYLAWS COULD DELAY OR DISCOURAGE A TAKEOVER ATTEMPT.
Our articles of incorporation and bylaws contain provisions that may delay or discourage a takeover
attempt that a shareholder might consider in their best interest, including takeover attempts that
might result in a premium being paid on shares of our Common Stock. These provisions, among other
things provide that only the board of directors or president may call special meetings of the
shareholders; and establish certain advance notice procedures for nominations of candidates for
election as directors and for shareholder proposals to be considered at shareholders meetings.
ITEM 2. PROPERTIES
The Company leases its principal offices in Longwood, Florida. The lease is for a term of
three (3) years, ending December 2010, and provides for monthly rental payments of $5,500.48.
ITEM 3. LEGAL PROCEEDINGS Effective October 14, 2005, the Company terminated the employment of John
R. DePhillipo, the Companys former Chief Executive Officer and Chief Financial Officer and a
former director of the Company. Mr. DePhillipo commenced two lawsuits allegedly arising out of his
termination by the Company for cause, as defined in his Employment Agreement with the Company.
In an Action filed in the United States District Court for the Eastern District of
Pennsylvania, John R. DePhillipo v. Robert P. Ricciardi, Civil Action No. 05-5906, Mr. DePhillipo
alleged that Dr. Ricciardi, a Director and Officer of the Company, (1) caused Mr.
DePhillipos employment with the Company to be wrongfully terminated and therefore is personally
liable for all severance owed Mr. DePhillipo, in the amount of at least $75,000; (2) was
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personally liable for Mr. DePhillipos unpaid back salary of $84,000 simply because Mr. Ricciardi is an
officer and/or director of the Company; and (3) acted sufficiently maliciously to justify punitive
damages being assessed against Dr. Ricciardi of $10,000,000. Under the terms of the Companys
By-laws and Pennsylvania law, the Company is obligated both to reimburse Mr. Ricciardi for his
costs of defending this action and is required to advance him the costs of the expense of such a
defense. Counsel for Dr. Ricciardi entered an answer to this action and subsequently the action
against Dr. Ricciardi was dismissed with prejudice in March 2006. There is thus no further
contingent liability with regard to this matter.
In a separate Action filed by Mr. DePhillipo against the Company in November 2005 in the
Superior Court of New Jersey, Law Division, Atlantic County, John R. DePhillipo v. GeneLink, Inc.,
Docket No. ATL-L-7479-05, Mr. DePhillipo has alleged that his termination by the Company for
cause was improper and therefore he is entitled to in excess of $1,500,000 in severance pay under
the terms of an employment agreement, allegedly entered into effective January 1, 2005 (the
Employment Agreement) and an additional $84,000 in accrued and unpaid compensation. The Company
has filed an Answer denying the material allegations of the Complaint and asserting a number of
affirmative defenses. The Company believes Mr. DePhillipos claims are without merit and intends to
vigorously defend against those claims. The Company has also filed counterclaims against Mr.
DePhillipo for breach of fiduciary duty, conversion, negligent misrepresentation, unjust enrichment
and fraud while Mr. DePhillipo served as the Companys Chief Executive Officer, President and Chief
Financial Officer. The counterclaims seek recovery in excess of that sought by Mr. DePhillipo in
the Complaint. The trial is currently scheduled to commence April 14, 2008.
The Company has received a notice of an alleged patent infringement from an Australian
bioscience company, Genetic Technologies Limited (GTG), that they have certain rights under filed
patents to which GeneLink may be infringing upon. It is the opinion of the Companys patent
counsel that there is no infringement, and that in the event there is an infringement, it will not
effect the Companys business because GTGs patents are not material to the Companys technology.
The Company received this notice in 2004, and there has been no further action or contact on this
matter.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
PART II
ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.
The Companys common stock is listed on the NASDAQ and OTC Bulletin Board under the System
GNLK. Set forth below, for the periods indicated, is the range of high and low bid information
for the Companys common stock for the past 2 years, when the Companys common stock began trading.
These quotations reflect inter-dealer prices without retail mark-up, mark-down or commission, and
may not represent actual transactions.
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As of March 10, 2008, there were 178 holders of record of the Companys Common Stock. The
Company has never paid dividends and do not anticipate paying any dividends in the future. The
Company anticipates that it will retain all future revenues for working capital purposes.
The payment of cash dividends in the future will be at the discretion of the Board of
Directors and will depend upon such factors as earnings levels, capital requirements, the Companys
financial condition and other factors deemed relevant to the Board of Directors. In addition, the
Companys ability to pay dividends may become limited under future loan agreements which may
restrict or prohibit the payment of dividends.
EQUITY COMPENSATION PLAN INFORMATION
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RECENT SALES OF UNREGISTERED SECURITIES.
The Company issued 68,750 and 510,000, shares of Common Stock for consulting services
rendered to the Company valued at $3,688 and $96,476 for the years ended December 31, 2007, and
2006, respectively. These shares were issued in reliance upon Rule 506 of Regulation D under the
Securities Act of 1933. In addition, the Company paid $155,312 in fundraising commissions related
to private placements during 2007 that were charged to paid in capital.
In August 2007, the Company issued a private placement memorandum for up to $1,700,000 of
units consisting of restricted common stock at $.075 per share with an attached warrant to acquire
1/4 of a share of common stock. The warrants are exercisable for 5 years at a price of $.10 per
share. During November 2007, the Company closed on $1,431,400 of units with proceeds allocated to
stock of $1,161,159 and attached warrants of $270,241. These shares and warrants were issued in
reliance upon Rule 506 of Regulation D under the Securities Act of 1933.
In connection with this offering, the Company issued 2,575,250 of dealer warrants with 5
year terms. 515,050 of the dealer warrants have an exercise price of $.10 per share, while the
remaining 2,060,200 are exercisable at $.075 per share.
During the year ended December 31, 2007 and 2006, the Company issued $137,500
and $827,890 principal amount of convertible secured promissory notes and issued 687,500 and
4,539,450 shares of restricted Common Stock in connection with the issuance of the notes.
During 2007 the Company issued 5,093,024 shares of common stock as conversion of
promissory notes and accrued interest. The value of the notes converted as of December 31, 2007
was $254,653.
During the year ended December 31, 2006, the Company issued $827,890 principal amount of
convertible secured promissory notes and issued 4,139,452 shares of restricted Common Stock in
connection with the issuance of the notes. The aggregate amounts recorded in connection with the
issuance of the notes and the stock were $1,008,788, representing the $827,890 of gross proceeds of
notes plus debt issuance costs related to the stock issuance of $180,898. The notes and shares
were issued in reliance upon Rule 506 of Regulation D under the Securities Act of 1933.
In January 2006, the Company issued $200,000 of bridge notes in reliance upon Rule 506 of
Regulation D under the Securities Act of 1933. The bridge notes were refinanced in June 2006 upon
issuance of the convertible secured promissory notes referenced above.
During the year ended December 31, 2005, the Company issued stock in settlement of a debt
agreement. The Company issued 640,369 shares of common stock to settle $75,000 of debt and
interest accrued on the note. These shares were issued in reliance upon Rule 506 of Regulation D
under the Securities Act of 1933.
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During the year ended December 31, 2005, the Company issued 2,250,000 shares of common stock
and 1,500,000 warrants to purchase common stock for aggregate cash consideration of $450,000.
These shares and warrants were issued in reliance upon Rule 506 of Regulation D under the
Securities Act of 1933. During the year ended December 31, 2005, the Company issued 640,369 shares
in exchange for the satisfaction of $75,000 principal amount of debt, plus accrued interest. These
shares were issued in reliance upon Rule 506 of Regulation D under the Securities Act of 1933.
Critical Accounting Policies
Stock options:
The Financial Accounting Standards Board has issued SFAS No. 123R, which defines a fair value
based method of accounting for an employee stock option and similar equity instruments and
encourages all entities to adopt that method of accounting for all of their employee stock
compensation plans. However, it also temporarily allowed an entity to continue to measure
compensation cost for those plans using the method of accounting prescribed by Accounting
Principles Board Opinion No. 25 (APB 25). Entities electing to remain with the accounting in APB
25 must make proforma disclosures of net income (loss) and, if presented, earnings (loss) per
share, as if the fair value based method of accounting defined in SFAS 123R had been adopted. As
required, the Company has adopted SFAS No. 123R for the years ended December 31, 2007 and 2006.
Amortization of patents:
Legal and professional fees and expenses in connection with the filing of patent and trademark
applications have been capitalized and are amortized over fifteen years on a straight-line basis.
The Company has filed for and has patents pending in the USA and foreign countries on its method
of DNA gathering. The Company has a registered trademark for its name, logo, and the name DNA
Collection Kit ®. The Company also filed for and has patents pending on its three proprietary
genetic indicator tests and has received a patent in Australia regarding its Oxidative Stress
Profile.
Revenue and cost recognition:
GeneLink receives separate fees for the kits and for the lab services. Upon entering into a
distribution arrangement with GeneLink, a distributor will order kits at a price negotiated between
GeneLink and the distributor. Upon the distributor receiving from a customer of such distributor
an order for the underlying genetically guided skin care or nutrition product that the distributor
is selling, a sample of the customers DNA will be obtained and the kit will be sent to the lab for
analysis. At that time the distributor will be charged an agreed upon price for the lab services.
This is in addition to the price of the kits.
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The price for each of the kits and the lab services come about through arms-length negotiations
between GeneLink and its distributors and are based upon the costs incurred by GeneLink for the
kits and the lab services.
Upon termination of a distribution arrangement, GeneLink is not required to repurchase any kits
remaining in the possession of the distributor. Typically, only a small number of kits are
purchased at any time. The distributor has some period after the end of the distribution
arrangement to sell off any remaining kits. If it does, GeneLink will provide the lab services for
each kit sold.
Use of Estimates:
The preparation of financial statements in conformity with generally accepted accounting
principles requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the
financial statements and reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
Evaluation of liability in respect of litigation and regulatory proceedings is determined on a
case-by-case basis and represents an estimate of probable losses after considering among other
factors, the progress of each case, our experience and the experience of others in similar cases,
and the opinions and views of legal counsel. Given the inherent difficulty of predicting the
outcome of our litigation matters, particularly in cases in which claimants seek substantial or
indeterminate damages, we cannot estimate losses or ranges of losses for cases where there is only
a reasonable possibility that a loss may have been incurred. See Legal Proceedings in Part I,
Item 3 of the Annual Report on Form 10-KSB for information on our judicial, regulatory and
arbitration procedures.
Results of Operations
COMPARISON OF FISCAL YEAR ENDED DECEMBER 31, 2007 TO FISCAL YEAR ENDED DECEMBER 31, 3006.
Assets. The Companys assets increased from $548,481 at December 31, 2006 to $1,383,824 at
December 31, 2007, an increase of $835,343. This increase was primarily due to an increase in cash
and cash equivalents from $149,695 at December 31, 2006 to $972,371 at December 31, 2007, an
increase of $822,676. This increase of cash resulted from the sale of common stock and warrants by
the Company in November 2007 in the amount of $1,431,398 , less fees and costs incurred in
connection with such offering.
Liabilities. The Companys liabilities decreased from $1,407,784 at December 31, 2006 to
$1,190,457 at December 31, 2007, a decrease of $217,327. This decrease in liabilities was
primarily due to a decrease in accrued compensation from $710,323 at December 31, 2006 to $144,168
at December 31, 2007, a decrease of $566,155, relating to a decrease in $662,617 of accrued
compensation owed to an officer and director of the Company. This decrease in liabilities was
partially offset by an increase in convertible secured promissory notes payable, net of debt
issuance and stock conversion discounts, from $298,390 at December 31, 2006 to $487,968 at December
31, 2007, an increase of $189,578, as Company issued $380,000 principal
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amount of convertible secured promissory notes in 2007 and note holders converted $229,253 of
notes into common stock of the Company in 2007; and an increase in accounts payable and accrued
expenses from $365,590 at December 31, 2006 to $439,399 at December 31, 2007, an increase of
$73,809. The $487,968 and $298,390 amount of convertible secured notes payable reflected on the
balance sheets as of December 31, 2007 and 2006, respectively, are net of debt issuance costs and
stock conversion discounts. The outstanding amount of convertible secured notes payable as of
December 31, 2007 and 2006 was $728,812 and $827,890, respectively.
Losses. The Company incurred an operating loss of $1,572,204 for the fiscal year ended
December 31, 2007, as compared to an operating loss of $793,576 for the fiscal year ended December
31, 2006, an increase of $778,628. This increase in operating losses was primarily due to the
incurring of $363,400 of expenses in connection with grants of options and warrants to officers and
directors during the year ended December 31, 2007; an increase in professional fees from $173,590
for the year ended December 31, 2006 to $346,148 for the year ended December 31, 2007, an increase
of $172,558, which increase relates to costs incurred in connection with the litigation brought
against the Company by its former chief executive officer; an increase in selling, general and
administrative expenses from $476,539 for the year ended December 31, 2006 to $644,948 for the year
ended December 31, 2007, an increase of $168,409, of which $87,520 related to increased interest
expenses associated with the Companys convertible secured promissory notes; and the decrease in
gross profits from $110,253 for the year ended December 31, 2006 to $23,551 for the year ended
December 31, 2007.
Revenues. The Companys total operating revenues for the fiscal year ended December 31, 2007
were $97,744 as compared to $175,674 for the fiscal year ended December 31, 2006, a decrease of
$77,930.
Expenses. Total expenses for fiscal year ended December 31, 2007 were $1,669,948, as compared
to $969,250 for the fiscal year ended December 31, 2006, an increase of $700,698. This increase in
expenses is primarily due to the incurring of $363,400 of expenses in connection with grants of
options and warrants to officers and directors during the year ended December 31, 2007, an increase
in professional fees from $173,590 for the year ended December 31, 2006 to $346,148 for the year
ended December 31, 2007, an increase of $172,558, which increase relates to costs incurred in
connection with the litigation brought against the Company by its former chief executive officer;
and an increase in selling, general and administrative expenses from $476,539 for the year ended
December 31, 2006 to $644,948 for the year ended December 31, 2007, an increase of $168,409, of
which $87,520 related to increased interest expenses associated with the Companys convertible
secured promissory notes.
COMPARISON OF FISCAL YEAR ENDED DECEMBER 31, 2006 TO FISCAL YEAR ENDED DECEMBER 31, 3005.
Assets. The Companys assets increased from $445,276 at December 31, 2005 to $548,481 at December
31, 2006, an increase of $103,250. This increase was primarily due to an increase in cash from
$15,275 at December 31, 2005 to $149,695 at December 31, 2006.
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Liabilities. The Companys liabilities increased from $1,057,879 at December 31, 2005 to
$1,407,784 at December 31, 2006, an increase of $349,905. This increase in liabilities was
primarily due to an increase in long term loans payable net of debt issuance and stock conversion
costs from $0 at December 31, 2005 to $298,390 at December 31, 2006 in connection with the
Companys issuance of convertible secured promissory notes in 2006.
Losses. The Company incurred an operating loss of $793,576 for the fiscal year ended December
31, 2006, as compared to an operating loss of $1,281,157 for the fiscal year ended December 31,
2005, a decrease of $487,581. This decrease in losses was primarily due to a decrease in general
and administrative expenses from $802,984 for the fiscal year ended December 31, 2005 to $476,539
for the fiscal year ended December 31, 2006, as the Company did not pay any compensation to or
expenses of its former chief executive officer and president or his wife in 2006, and a decrease in
advertising and promotion expenses $209,370 for the fiscal year ended December 31, 2005 to $14,369
for the fiscal year ended December 31, 2006, as the Company focused on the change in management and
on obtaining sufficient funding to develop and implement its new business plan. This decrease in
expenses was accompanied by a decrease in revenues from $396,923 for the fiscal year ended December
31, 2005 to $175,674 for the fiscal year ended December 31, 2006. The Companys gross margin
dropped from $167,528 for the fiscal year ended December 31, 2005 to $110,253 for the fiscal year
ended December 31, 2006. Gross profit margin increased from 42% to 62%.
Revenues. The Companys total operating revenues for the fiscal year ended December 31, 2006
were $175,674, as compared to $396,923 for the fiscal year ended December 31, 2005, a decrease of
$221,249.
Expenses. Total expenses for fiscal year ended December 31, 2006 were $969,250, as compared
to $1,678,080 for the fiscal year ended December 31, 2005, a decrease of $708,830. This decrease
in expenses is primarily due to a decrease in general and administrative expenses from $802,984 for
the fiscal year ended December 31, 2005 to $476,539 for the fiscal year ended December 31, 2006, as
the Company did not pay any compensation to or expenses of its former chief executive officer and
president or his wife in 2006, and a decrease in advertising and promotion expenses $209,370 for
the fiscal year ended December 31, 2005 to $14,369 for the fiscal year ended December 31, 2006, as
the Company focused on the change in management and on obtaining sufficient funding to develop and
implement its new business plan.
Segment Operating Results
The following table sets forth the net revenues, operating expenses and pre-tax earnings of
our segments for the year ended December 31, 2007:
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The following table sets forth the net revenues, operating expenses and pre-tax earnings of
our segments for the year ended December 31, 2006:
Liquidity and Capital Resources
For 2007, the Companys primary liquidity requirement was the implementation and funding of
sales and marketing efforts and funding working capital. For 2008, the Companys primary liquidity
requirement will be the funding of the Companys sales and marketing efforts and the payment of
past obligations of the Company.
Cash and Cash Equivalents. On December 31, 2007, the Companys cash and cash equivalents
amounted to $972,371 as to compared to $149,695 at December 31, 2006, an increase of $822,676.
This increase resulted from the Companys offerings of $1,431,400 of common stock and warrants,
less fees and expenses, in November 2007. During 2007, the Companys operating activities utilized
$705,086 as compared to utilizing $296,523 in 2006, an increase of
$408,563. Cash utilized during
these periods resulted from the Companys net losses for such periods and the payment of accounts
payable.
Investing activities utilized $90,827 in 2007, as compared to utilizing $42,646 in 2006.
Financing activities provided $1,618,589 in 2007, as compared to $523,023 in 2006, primarily
through the issuance of $1,431,400 of shares of common stock and warrants and the issuance of
$342,500 of loans and notes payable, less $155,312 of cash costs associated with such issuances.
The $487,968 and $298,390 of convertible secured promissory notes payable as of December 31, 2007
and 2006, respectively, as reflected on the Balance Sheet on page 29 are net of debt issuance and
stock conversion discounts. The outstanding amount of convertible secured notes payable as of
December 31, 2007 and 2006 were $728,812 and $827,890, respectively.
The Company will require approximately $500,000 to $1,500,000 of working capital, depending on
how quickly the Companys distributors and GeneWize can commence and rollout their respective
marketing and sales efforts, to fund the Companys sales and marketing efforts and to pay existing
oblig | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||