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EXHIBIT 99.1
CAUTIONARY STATEMENTS FOR PURPOSES OF THE "SAFE HARBOR" PROVISIONS OF THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
We desire to take advantage of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Many of the following important
factors discussed below have been discussed in our prior SEC filings.
You should be cautioned that the following important factors have affected,
and in the future could affect, our actual results. There may also be
additional factors not discussed in this report that could also affect future
results. These factors could cause our future financial results to differ
materially from those expressed in any forward-looking statements made by us.
Forward-looking statements may relate to such matters as:
- our ability to generate future revenues;
- the potential commercialization of our products;
- the optimization of production costs; and
- the ability to enter into future business collaborations and
marketing partnerships
Forward-looking statements may include words such as "will," "should,"
"could," "anticipate," "believe," "plan," "estimate," "expect," intend," and
other similar expressions. This list does not constitute all factors which you
should consider prior to making an investment decision in our securities. You
should also not assume that the information contained herein is complete or
accurate in all respects after the date of this filing. We disclaim any duty
to update the statements contained herein.
WE HAVE EXPERIENCED NET OPERATING LOSSES SINCE OUR INCEPTION, ARE LIKELY TO
CONTINUE TO EXPERIENCE NET OPERATING LOSSES IN THE SHORT TERM, AND MAY NEVER
BECOME PROFITABLE.
We have experienced net operating losses since our inception. As of July
31, 2000, we have an accumulated deficit of $85,569,000. Until we realize
significant revenues from our nutritional products, we expect to continue to
experience net operating losses. Our balance of cash and cash equivalents at
July 31, 2000 was $4,631,000 and, as of July 31, 2000, we had $19,451,000 in
short term investments and marketable securities. At April 30, 2000, these
amounts were $3,395,000 and $21,511,000, respectively. We must achieve sustained
profitability to generate the cash necessary to be a viable business in the long
term, and at this time we have not yet generated a sustained source of revenues
to achieve this.
IF OUR INFANT FORMULA LICENSEES DO NOT INTRODUCE PRODUCTS CONTAINING OUR
NUTRITIONAL OILS IN THE UNITED STATES OR BROADEN THEIR USE OF OUR NUTRITIONAL
OILS IN THEIR PRODUCTS OVERSEAS, WE MAY NOT BE ABLE TO REACH REVENUE LEVELS THAT
WOULD MAKE US PROFITABLE.
Nutritional product sales and royalties are likely to be our main source of
revenues in the future. Although we sell some of our nutritional oils into the
adult nutritional products market, approximately two-thirds of our current
nutritional product revenues come from our license agreements with infant
formula manufacturers. As such, we depend on the licensees' sales of products
that include our nutritional oils. Although some of our licensees have included
our nutritional oils in some of their products outside the United States, we
cannot predict whether any licensee will introduce infant formula products
containing our nutritional oils in the United States, broaden their use of our
nutritional oils overseas, or whether any of our other licensees will
incorporate our nutritional oils into their products. Until these events occur
and we recognize significant revenues as a result of increased product
introductions, we do not expect to be profitable from the sale of nutritional
oils to our licensees.
Ultimately our success in the infant formula industry depends on growing
acceptance of our nutritional oils as necessary or beneficial additives to
infant formulas. Notwithstanding existing clinical results that have
demonstrated the beneficial effects of adding our nutritional oils to infant
formula, some experts in the field of infant nutrition do not believe that our
nutritional oils are necessary or that they provide any long-term beneficial
effects. Many of these experts recommend that mothers breastfeed rather than use
infant formulas whether or not they contain our nutritional oils. Some experts
also believe that infant formula without our oils contains sufficient precursor
fats that infants can convert into DHA and ARA as needed. In addition, some
physicians are unimpressed by studies showing that infant formulas fortified
with our oils improve infants' cognitive ability at early ages, suggesting that
these results may not carry over to improved results later in life. Due to these
differences in opinion, we are subject to the risk that the use of DHA and ARA
in infant formula may never gain widespread acceptance.
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IF ADDITIONAL POSITIVE CLINICAL RESULTS ARE NOT OBTAINED, WE MAY NOT BE ABLE TO
DEVELOP A PROFITABLE MARKET FOR OUR NUTRITIONAL OILS OUTSIDE OF THE INFANT
FORMULA MARKET.
Approximately one-third of our current nutritional product revenues come
from sales of our nutritional oils to distributors and directly to consumers in
the adult supplement market. Investigators at universities and other research
centers, such as the National Institutes of Health, have observed a relationship
between low levels of DHA and a variety of health risks, including increased
cardiovascular problems, cystic fibrosis, cancer, and neurological and visual
disorders. We are currently trying to establish what contribution, if any,
supplementation with our oils will make in addressing these problems. Although
clinical data is not required to market nutritional supplements to consumers or
distributors outside of the infant formula market, we believe that further
clinical studies are needed to validate the benefits of DHA supplementation.
Accordingly, we have recently begun sponsoring studies to further investigate
the potential benefit of DHA supplementation on cardiovascular health and breast
cancer, and we, as well as others, are conducting research regarding the impact
of DHA supplementation on cystic fibrosis and visual and neurological disorders.
Unless these studies, which are more extensive than earlier pilot studies,
establish the positive impact of DHA supplementation, we may only have a limited
adult nutritional supplement market opportunity.
EVEN IF OUR PRODUCTS DO OBTAIN WIDESPREAD ACCEPTANCE, WE MAY NOT BE ABLE TO
PRICE THE PRODUCTS AT A LEVEL THAT WOULD ALLOW US TO BE PROFITABLE.
Infant formula pricing is very competitive and the market is very sensitive
to product price changes. Because the inclusion of our oils into infant formula
may add 10% to 20% to the retail cost of standard infant formula, there is the
risk that our licensees may never be able to sell supplemented products at a
price that will allow them to gain broad market acceptance while at the same
time be profitable. Although our current contracts with licensees outline
product pricing and royalty rates, we cannot predict whether these pricing
structures will allow our licensees to be competitive in the future. If we have
to reduce our prices, we may not be able to sell products at a price that would
enable us to be profitable. We are currently negotiating flat-rate pricing with
our infant formula licensees and have agreed to accept flat-rate pricing
purchase orders from our licensees in the interim until formal agreements are
finalized. We do not believe that this change is material to investors as the
economics of flat-rate pricing will be similar to our current economics, with
the current transfer price and royalty combined into one price with a slight
discount. Although either our current pricing structure or the flat-rate pricing
structure will enable us to achieve profitability if our products receive
widespread acceptance, we cannot predict whether either of these pricing
structures will enable our licensees to achieve success marketing these
products. None of our license agreements requires our licensees to purchase any
minimum amount of products from us now or in the future and all of our license
agreements allow our licensees to manufacture our products themselves or
purchase nutritional oils from other sources.
IF WE ARE UNABLE TO INCREASE OUR PRODUCTION CAPACITY OR ENTER INTO FAVORABLE
AGREEMENTS WITH THIRD PARTIES TO PRODUCE OUR OILS, OUR CUSTOMERS MAY NOT BE ABLE
TO OBTAIN A SUFFICIENT SUPPLY OF DHA AND ARA AT A COMMERCIALLY REASONABLE PRICE
TO GAIN A BROAD ACCEPTANCE OF THESE PRODUCTS AND OUR FUTURE REVENUES FROM THESE
PRODUCTS MAY BE LIMITED.
To meet our customers' projected demand for our nutritional oils, we have
developed a process for the large-scale production of our oils at our
Winchester, Kentucky manufacturing plant. We estimate the world-wide infant
formula market to be approximately $6 billion. If our licensees were to
penetrate 100% of this market with DHA and ARA supplemented formulas, we
estimate that we would receive approximately $300 million in revenues annually
from these sales. To date, our licensees have penetrated less than 2% of the
world-wide infant formula market. While our current production level in our
plant is sufficient to meet this current demand, if demand increases beyond our
current production capabilities, we may be unable to produce the required
quantities of oil cost effectively. Although our licensees have a right to
manufacture DHA and ARA, we are not aware of any of our licensees doing so or
preparing to do so. We estimate that it may take a licensee approximately one
year or more to develop their process of making our oils. Accordingly, if we are
unable to meet demand, our licensees may not be able to manufacture product for
themselves for at least one year. We believe that we can increase production to
supply approximately 20% to 30% of the world-wide infant formula market with
additional capital expenditures. However, our ability to maintain commercial
production at those levels at our plant has not been successfully tested. As a
precaution, we have developed plans to expand our existing facilities to
accommodate increased production. In order to double our capacity at our current
facility, it would cost as much as $20 million, which would require us to raise
significant amounts of capital. We have also conducted DHA production trials
with third party manufacturers. However, we do not currently have a third party
manufacturing agreement in place to supply us with DHA-containing oil. If we are
unable to cost effectively manufacture our DHA-containing oils at our plant, or
we are unable to enter into a favorable third party manufacturing agreement or
our licensees are unable to find alternative sources for our DHA-containing
oils, our licensees may not be able to meet future demand and our revenues may
be limited in the future.
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Although we are able to produce ARA-containing oil at our Winchester plant,
we have entered into an agreement with a third party manufacturer, DSM Food
Specialties, to supply our ARA-containing oil. If DSM Food Specialties fails to
supply us with required amounts under the contract, we would not be able to meet
our customers' demands. In this case, we would have to either manufacture the
ARA-containing oil at our plant, which would reduce our DHA-containing oil
production capacity, or enter into other third party manufacturer supply
agreements. If we are unable to find alternative supply sources or are unable to
cost effectively manufacture the ARA-containing oil in our Winchester plant, our
licensees may not be able to meet future product demand and our future revenue
from sales of ARA-containing oils may be limited.
BECAUSE WE ARE STILL IN THE EARLY STAGES OF PRODUCT DEVELOPMENT, WE WILL NEED
SIGNIFICANT ADDITIONAL CAPITAL TO CONTINUE OUR RESEARCH AND DEVELOPMENT, CONDUCT
PRODUCT TESTING, INCLUDING PRECLINICAL AND CLINICAL TRIALS, AND MANUFACTURE AND
MARKET OUR PRODUCTS.
We have a number of products that are in the early stages of research and
development, product testing, manufacturing or marketing. Although we receive
revenues from sales of infant formula containing our nutritional oils, our
dietary supplement Neuromins(R), our stable isotope products, and some other
products, the aggregate revenue from these products is currently insufficient to
internally fund our product development, manufacturing and marketing needs.
Therefore, we will continue to require additional outside sources of funding. We
estimate that we will need approximately $30-40 million over the next several
years to fund our research and development, product testing, manufacturing, and
marketing at budgeted levels. Additionally, if our business grows, these needs
will increase.
To continue to fund our growth, we will pursue various sources of funding,
which may include equity issuances, asset based borrowing, lease financing, and
collaborative arrangements with partners. Our existing term loan, which has a
current balance at September 28, 2000 of approximately $564,000, requires us to
meet certain debt covenants, which include maintaining a cash, cash equivalents
and marketable securities balance of at least $12 million and meeting certain
debt/equity and other ratios. Because additional debt financing arrangements
would have to comply with these financial covenants, we may not be able to
secure additional debt financing on terms acceptable to us. Additionally,
funding from other sources may not be available, or may not be available on
terms that would be commercially acceptable or permit us to continue the planned
commercialization of our products or to expand our production capacity. If we
obtain funds through collaborative or strategic partners, these partners may
require us to give them technology or product rights, including patents, that
could ultimately diminish our value. If we cannot secure adequate funding, we
may need to scale back our research, development, manufacturing, and
commercialization programs which may have a materially adverse affect on our
future business.
THE MARKET PRICE OF OUR COMMON STOCK MAY EXPERIENCE A HIGH LEVEL OF VOLATILITY
DUE TO FACTORS SUCH AS ITS RELATIVE ILLIQUIDITY, THE VOLATILITY IN THE MARKET
FOR BIOTECHNOLOGY STOCKS GENERALLY, AND THE EFFECT OF SHORT TERM EVENTS LIKE
PRODUCT LAUNCHES AND LICENSE ANNOUNCEMENTS.
We are a public emerging growth company in the biosciences sector. As
frequently occurs among these companies, the market price for our common stock
may experience a high level of volatility. During the fifty-two week period
ending September 21, 2000, our common stock price has traded between $6.25 and
$32.00. During the fifty-two week period ending September 21, 1999, our common
stock price ranged from $5.00 to $12.00. The following are examples of items
that may significantly impact the market price for our common stock:
- announcements of technical innovations, new commercial products, new
license arrangements or strategic partnerships by us or our competitors;
- patent or other intellectual property disputes;
- quarterly fluctuations in our results of operations;
- regulatory developments concerning our products and our competitors'
products; and
- general market conditions for emerging growth companies and bioscience
companies.
Because we may experience a high level of volatility in our common stock,
you should not invest in our stock unless you are prepared to handle a
significant loss of your capital. At any given time, you may not be able to sell
your shares at a price you think is acceptable.
The market liquidity for our stock is very low. As of November 8, 2000, we
had 17,806,079 shares of common stock outstanding. Since our initial public
offering of common stock on November 23, 1993, the average daily trading volume
in our common stock as reported on the NASDAQ National market has been 149,045
shares. The average trading volume in our common stock during the fifty-two week
period ending September 30, 2000 was 100,004 shares.
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The average trading volume in our common stock during the fifty-two week period
ending September 30, 1999 was 58,379 shares. Although a more active trading
market may develop in the future, the limited market liquidity for our stock may
effect your ability to sell and the price at which you are able to sell your
shares of common stock.
IF SIGNIFICANT SHARES ELIGIBLE FOR FUTURE SALE ARE SOLD OR REGISTRATION RIGHTS
ARE EXERCISED, THE RESULT MAY DEPRESS OUR STOCK PRICE BY INCREASING THE SUPPLY
OF OUR SHARES IN THE MARKET AT A TIME WHEN DEMAND MAY BE LIMITED.
Because we continue to require additional outside sources of capital to
finance, among other things, our research and development, product testing, and
the manufacturing or marketing of our products, we may need to raise additional
capital through the sale of equity securities. As of November 8, 2000, we had
17,806,079 shares of common stock outstanding, stock options outstanding to
purchase an aggregate of 2,970,330 shares of common stock at various exercise
prices ranging from $6.25 to $34.25 per share, and warrants outstanding to
purchase up to 734,391 shares of common stock at exercise prices between $7.51
and $18.76. To the extent that these options and warrants for our common stock
are exercised, the increase in the number of our outstanding shares of common
stock may adversely affect the price for our common stock. This could hurt our
ability to raise capital through the sale of equity securities. Additionally,
some of our stockholders who bought shares or warrants from us in private
placements have registration rights. If the stockholders were to exercise their
registration rights when we are seeking to raise capital by selling stock in a
registered offering, the result could effectively prevent us from doing so.
IF OUR LICENSEES DO NOT RECEIVE NECESSARY REGULATORY APPROVALS FOR THE USE OF
OUR NUTRITIONAL SUPPLEMENTS IN INFANT FORMULAS, THEY WILL NOT BE ABLE TO MARKET
FORMULA CONTAINING OUR PRODUCTS.
Many of our products and the manufacturing and marketing of these products
are subject to extensive regulation by the FDA and similar regulatory
authorities in other countries depending on the product type and method of
manufacture. For example, the FDA regulates, to varying degrees and sometimes in
very different ways, infant formulas, dietary supplements, foods, medical foods,
animal feed and pharmaceutical products.
To date, infant formula containing our nutritional oils has not received
regulatory approval in the United States. As a result of prior filings for this
approval by our licensees, the FDA has raised questions pertaining to the
results of animal studies relating to DHA and ARA concerning the slightly
enlarged livers and spleens of the laboratory rats who consumed large quantities
of these oils in the studies. We, along with our licensees, are in the process
of responding to the FDA to address these questions. As part of this process,
during February 2000, we filed a "generally recognized as safe" ("GRAS")
notification with the FDA for the use of our DHA and ARA nutritional oils in our
licensees' infant formula. If the FDA review results in a favorable outcome,
each of our infant formula licensees will need to obtain a separate FDA
authorization before marketing an infant formula with our sources of DHA and
ARA.
There can be no assurance that our GRAS notification, the final
determination of which may take a minimum of three to six additional months from
the effective date of this registration statement, will have a favorable
outcome, and even if it does, there can be no assurance that our licensees will
be able to obtain the FDA approval to market an infant formula containing our
products in the United States. If we are unable to obtain these approvals, or if
approvals are delayed, our ability to successfully market products directly and
through our licensees, and to generate revenues from infant formula product
sales or royalties, would be impaired.
OUR CURRENT PATENTS MAY NOT BE ABLE TO PROVIDE PROTECTION AGAINST COMPETITIVE
PRODUCTS AND WE MAY BE UNABLE TO PROTECT OUR INTELLECTUAL PROPERTY PORTFOLIO IN
THE FUTURE.
European and U.S. patent authorities have not adopted a consistent policy
regarding the breadth of claims allowed for health and bioscience patents. Our
issued patents, or patents that we may obtain in the future, may not afford
adequate protection against competitors with competing technology because
governmental agencies may revoke our patents for being too broad or may limit
the scope of our patents. If this happens, companies may be able to produce
products using our previously patented technology. We may also incur substantial
costs in the future in defending our patents.
OmegaTech, Inc., Monsanto Corporation, Aventis S.A. and Nagase & Co. Ltd.
are challenging our European patent covering our DHA-containing oils. At a
recent hearing, a division of the European Patent Office revoked our patent on
the grounds that it is too broad. We immediately appealed this ruling, and as a
result, our patent was reinstated and it will remain in effect during the appeal
process, which may take up to two years. If the revocation is upheld upon our
appeal, or any other challenges to our patents are successful, our competitors
may be able to produce our products and, as a result we may experience decreases
in the future sales of our nutritional oils, decreases in the revenues on sales
of infant formula containing our oils and decreases in license fees related to
our oils. Although our revenues may decrease under our license agreements, the
revocation of our European DHA patent will not terminate any of our license
agreements.
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WE ARE AWARE OF SEVERAL PRODUCTS THAT ARE CURRENTLY AVAILABLE, AND PRODUCTS
UNDER DEVELOPMENT, THAT MAY PRESENT A SERIOUS COMPETITIVE THREAT TO OUR
PRODUCTS.
Our success depends upon achieving and maintaining a superior competitive
position in infant formula and adult nutritional product markets. Many of our
competitors including BASF, F. Hoffman-LaRoche Ltd., OmegaTech, Inc., Monsanto
Corporation, Aventis S.A. and Nagase & Co. Ltd. have substantially greater
research and development capabilities, marketing, financial and managerial
resources and experience in the industry. If a competitor develops a better
product or technology, our products or technologies may be rendered obsolete.
We believe that, to date, we have developed the most efficient production
method and purest forms of DHA and ARA oils; however, we are aware that other
methods of producing DHA and ARA are available. Although no company has yet
received approval to market these products in infant formula in the United
States, some infant formulas and other products now on the market outside the
United States use oils derived from other sources, such as fish or eggs. We are
aware of the development of a DHA-containing fish oil which provides an
alternative to our DHA oil for infant formula applications. Although it is a
lower cost product relative to our DHA, fish oil has odor, stability and taste
characteristics that may limit its usefulness. Only a very small percentage of
currently marketed supplemented infant formulas contains DHA and ARA that have
not been produced by us. Currently, fish oil based products dominate the adult
DHA supplement market. We are aware of the development of microencapsulated fish
oil products by several large companies, including BASF and F. Hoffman-LaRoche
Ltd. Although microencapsulation of the oil resolves much of the odor, stability
and taste issues found with fish oil, a microencapsulated product is
significantly more costly than regular fish oil. Because fish oil is
significantly less costly than our DHA oil, fish oil presents a substantial
competitive threat to our Neuromins(R) DHA. None of these companies has yet
received approval to include DHA derived from fish oil or eggs in infant formula
within the United States; however, some of these companies have received
approval to include DHA derived from fish oil in infant formula in Asia and DHA
and ARA derived from eggs in infant formula in Europe.
We are also aware that OmegaTech, Inc., an early stage company, is able to
produce DHA from a strain of fungus. OmegaTech, Inc. is currently challenging
our European DHA patent and, if their challenge is upheld on appeal a barrier to
their ability to compete with us would be eliminated. We are currently unable to
evaluate the degree of competitive threat that this fungal source of DHA will
present to our DHA oil in the future.
