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FILED PURSUANT TO RULE 424(B)(2)
REGISTRATION NO. 333-95313
PROSPECTUS
GELTEX PHARMACEUTICALS, INC.
247,357 SHARES OF COMMON STOCK
- We are registering a total of 247,357 shares of GelTex common stock for
issuance upon the exercise of certain of our options and warrants, or Option
Shares and Warrant Shares, by the holders of the options and warrants.
- We will receive total proceeds of $7,037,105.40 if all of the options and
warrants are exercised.
- Our common stock trades on the Nasdaq National Market under the symbol "GELX."
- Our address is 153 Second Avenue, Waltham, MA 02451, and our telephone number
is (781) 290-5888.
THIS INVESTMENT INVOLVES
A HIGH DEGREE OF RISK.
YOU SHOULD PURCHASE
SHARES ONLY IF
YOU CAN AFFORD
A COMPLETE LOSS.
SEE "RISK FACTORS"
BEGINNING ON PAGE 3.
ON MARCH 3, 2000, THE CLOSING SALE PRICE OF ONE SHARE OF GELTEX COMMON STOCK AS
QUOTED ON THE NASDAQ NATIONAL MARKET WAS $21.56.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR COMPLETE. IT IS ILLEGAL FOR ANY PERSON TO TELL YOU
OTHERWISE.
THE DATE OF THIS PROSPECTUS IS MARCH 6, 2000
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PROSPECTUS SUMMARY
This summary highlights information incorporated by reference or contained
elsewhere in this prospectus. It is not complete and may not contain all of the
information that you should consider before investing in our securities. You
should read the entire prospectus carefully, including the "Risk Factors"
section, and you must consult the more detailed financial statements, and notes
to financial statements, incorporated by reference in this prospectus.
Whenever used herein, "our company," "we," "us" and "our" are references
collectively to GelTex Pharmaceuticals, Inc. and our wholly-owned subsidiaries.
THE COMPANY
We have historically focused our efforts on the development of
non-absorbed, polymer-based pharmaceuticals that selectively bind to and
eliminate target substances from the intestinal tract. With our acquisition of
SunPharm Corporation in November 1999, we acquired expertise in two chemically
related classes of molecules, polyamines and iron chelators. In October 1998, we
received approval from the United States Food and Drug Administration, or the
FDA, for our lead product Renagel* Capsules (sevelamer hydrochloride), and in
July 1999, we filed a New Drug Application, or NDA, with the FDA seeking
approval for our second compound, Cholestagel* (colesevelam hydrochloride).
Throughout 1999, we continued our product development efforts focused on
therapeutic agents for the treatment of obesity and infectious diseases.
Renagel Capsules had been studied in over 400 hemodialysis patients prior
to FDA approval, and is indicated for the treatment of elevated serum
phosphorous levels (hyperphosphatemia) in end stage renal disease patients.
Commercial sales of Renagel commenced in the United States in November 1998
through our joint venture, the Renagel JV, with Genzyme Corporation. In February
2000, the European Commission granted marketing approval in Europe for Renagel*
Capsules (sevelamer hydrochloride). The marketing approval is valid in the 15
member states of the European Union. Also, in February 2000, the Renagel JV
received marketing authorization from the Health Protection Branch of the
Canadian government.
In July 1999, we submitted a NDA to the FDA to market Cholestagel for the
treatment of hypercholesterolemia, a condition characterized by undesirably high
blood cholesterol levels. Prior to the submission of the NDA, Cholestagel had
been studied in eight clinical trails as a monotherapy and in combination with
statins, the current standard of treatment for lowering LDL cholesterol. In
December 1999, we entered into a Collaboration Agreement with Sankyo Pharma Inc.
under which we granted Sankyo exclusive rights to market Cholestagel in the
United States in exchange for our receipt of certain initial, milestone and
royalty payments from Sankyo. At the same time, we entered into another
Collaboration Agreement with Sankyo under which we sold Sankyo an option to
obtain the exclusive right to develop and market our second generation
cholesterol-lowering compound in the United States, Europe and Japan. Sankyo has
agreed to pay for all development costs for the second generation compound for
so long as their option to license the compound remains in effect.
During 1999, we continued our anti-obesity drug discovery program. We also
continued our efforts in the area of infectious diseases focusing on the
discovery of polymers that bind to and inactivate the toxins of Clostridium
difficile, a major cause of antibiotic-associated diarrhea.
We commenced operations in 1992 and have incurred operating losses since
that time. As of December 31, 1999, we had an accumulated deficit of
approximately $109 million.
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* Renagel and Cholestagel are registered trademarks of our company.
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RISK FACTORS
Before you purchase our securities, you should be aware that there are
risks, including those described below. You should consider carefully these risk
factors together with all of the other information contained elsewhere in this
prospectus or incorporated by reference before you decide to purchase our
securities.
WE DEPEND ON CORPORATE AND STRATEGIC COLLABORATIONS FOR RESEARCH AND DEVELOPMENT
AND SALES AND MARKETING OF PRODUCTS
Our lead product, Renagel (sevelamer hydrochloride), is currently being
sold in the United States through our joint venture with Genzyme, and we have
entered into a collaboration agreement with Chugai Pharmaceutical Co. Ltd., or
Chugai., for the development and commercialization of Renagel in Japan and other
Pacific Rim countries. In December 1999, we entered into a collaboration
agreement with Sankyo for the final development and commercialization of
Cholestagel (colesevelam hydrochloride) in the United States, as well as a
collaboration agreement granting Sankyo an option to obtain exclusive rights to
develop and commercialize our second generation cholesterol-lowering compound in
various territories. In connection with our acquisition of SunPharm, we acquired
a collaboration agreement with the University of Florida and a consulting
agreement with Dr. Raymond Bergeron, under which substantially all of our
research and a large portion of the early pre-clinical development work related
to polyamines and iron chelators will be conducted. From SunPharm, we also
acquired strategic alliances with Warner-Lambert Company, or Warner-Lambert, and
Nippon Kayaku Co., Ltd., or Nippon Kayaku, to develop and commercialize
diethylnorspermine, or DENSPM.
With respect to these products or potential products, we are relying or
plan to rely upon our corporate partners to:
- commercialize Renagel and other potential products;
- obtain certain regulatory approvals;
- conduct specified research and development activities, including in some
circumstances, clinical trials; and
- fund certain development activities.
If our existing collaborations are terminated or otherwise unsuccessful, we
will have to either delay the continued development and commercialization of
potential products or expend our own resources to fund such activities. A delay
in product development or commercialization or an increase in expenditures to
fund development, sales and marketing would likely require us to seek additional
sources of funding, and we cannot assure that such funding will be available
when needed or on acceptable terms. In addition, should we fail to retain the
relationship with the University of Florida and Dr. Bergeron, there can be no
assurance that we will be able to facilitate the efficient development of our
acquired intellectual property position in iron chelator and polyamine
technology.
To the extent that we are successful in maintaining our corporate partners
and strategic relationships, we will be dependent upon the efforts of our
collaborators. We cannot assure that the efforts of our collaborators will be
successful. Specifically, although Genzyme has built its own specialty sales
force to sell Renagel, it does not have previous experience marketing to
physicians who treat patients with kidney failure. We cannot assure that Genzyme
and Sankyo will be successful in achieving market acceptance for Renagel and
Cholestagel, respectively, at levels consistent with our projections for these
products.
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RISKS RELATED TO LEAD PRODUCTS AND POTENTIAL PRODUCTS AND FAILURE TO GENERATE
SIGNIFICANT PRODUCT SALES COULD IMPAIR OUR BUSINESS
As of December 31, 1999, our lead product, Renagel, has generated minimal
revenue from product sales in the amount of approximately $19.8 million since
commercial sale of the product commenced in the United States in November 1998.
We have not generated any other revenue from product sales. Although the U.S.
Food and Drug Administration, or FDA, has granted marketing approval for Renagel
capsules, we cannot assure that the product will receive market acceptance and
meet sales expectations. In Europe, the Committee for Proprietary Medicinal
Products, or CPMP, adopted a positive opinion for marketing authorization under
exceptional circumstances for Renagel, and such opinion will be forwarded to the
European Commission for a final decision. Notwithstanding the positive opinion
of the CPMP, we cannot assure that the European Commission will issue a
marketing authorization for Renagel. Renagel is also currently undergoing
regulatory review in Canada, and similarly, we cannot assure that regulatory
authorities in Canada will approve the product. Should approval in Europe or
Canada be forthcoming, we cannot assure that the product will be successfully
marketed by Genzyme in those territories.
On July 30, 1999, we filed a New Drug Application, or NDA, for Cholestagel
with the FDA for the treatment of hypercholesterolemia, a condition
characterized by undesirably high blood cholesterol levels. We cannot assure
that the results of any of our clinical trials or that our NDA will be
sufficient to meet the FDA's requirements for product approval. Failure to
obtain FDA approval for Cholestagel, or any significant delay in obtaining such
approval, would have a material adverse effect on our business. Even if FDA
approval for Cholestagel is obtained, we cannot assure that Cholestagel will
achieve market acceptance or meet expected sales goals.
PRODUCT DEVELOPMENT EFFORTS MAY NOT YIELD SUCCESSFUL PRODUCT INTRODUCTIONS AND
MARKET ACCEPTANCE
Our future business success will depend on our ability to successfully
develop and obtain regulatory approval to market new pharmaceutical products.
Successful commercialization of our product candidates under development depends
on whether we are able to:
- complete their development in a timely fashion;
- obtain and maintain patents or other proprietary protections;
- obtain required regulatory approvals;
- implement and maintain efficient, commercial-scale manufacturing
processes or maintain relationships with third party manufacturers for
such purposes;
- gain early entry into relevant markets;
- obtain reimbursement for sales of our products;
- establish and maintain sales, marketing, distribution and development
collaborations; and
- demonstrate the competitiveness of our products.
Our anti-obesity and infectious disease programs are the primary focus of
our internal research and development efforts and are in early stages of
pre-clinical development. Through the acquisition of SunPharm, we acquired
additional research and development programs being conducted by the University
of Florida, Warner-Lambert and Schein Pharmaceuticals. In addition, we acquired
from SunPharm rights to several compounds targeting multiple therapeutic areas
in various stages of
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research or development, including one pharmaceutical product in Phase II
clinical trials. Typically, Phase II trials are not sufficient to demonstrate
conclusively the safety or efficacy of the products under investigation, and the
success of substantial further clinical trials may be required before the FDA
may approve the products for commercialization. We cannot assure that any of our
potential products will:
- prove safe or effective in clinical trials;
- meet applicable regulatory standards;
- be produced in commercial quantities at acceptable cost; or
- be successfully marketed.
We cannot assure that our research and development activities will be
successful or that any product candidates will be chosen from pre-clinical
studies. Should we commence the clinical development of any additional
compounds, we cannot assure that clinical trials of products under development
will demonstrate the safety and efficacy of such products at all or to the
extent necessary to obtain regulatory approvals.
Development of a product requires substantial technical, financial and
human resources even if the product is not successfully completed. Due to
uncertainties that are part of the development process, many of the products
that we try to develop may not be successfully completed, execution of product
development in a timely manner may not be possible, and we may not be able to
fully fund development programs necessary to complete product development.
Delays or unanticipated increases in costs of development at any stage of
development, or our failure to obtain regulatory approval or market acceptance
for our products, could adversely affect our operating results.
WE HAVE EXPERIENCED OPERATING LOSSES, WHICH ARE EXPECTED TO CONTINUE
We have historically operated with net losses and expect that we will
continue to operate with net losses through at least the end of 2000.
As of December 31, 1999, we had an accumulated deficit of approximately
$109 million. The continuing development and commercialization of our potential
products will require the commitment of substantial resources. To achieve
sustained profitable operations, we must, independently or with our corporate
partners, successfully develop, obtain regulatory approval for, manufacture and
market our products. The amount of net losses and the time required to reach
sustained profitability are highly uncertain for us. We cannot assure that we
will be able to achieve or sustain profitability.
WE MAY REQUIRE SUBSTANTIAL ADDITIONAL CAPITAL, WHICH MAY BE DIFFICULT TO OBTAIN
Our cash requirements may potentially increase materially from those now
planned and could result in the need for substantial additional capital if any
of the following should occur:
- FDA approval of NDAs, particularly with respect to Cholestagel, are
delayed or not obtained;
- failure of negotiations with suppliers to result in an acceptable cost
for the manufacture of our products or potential products;
- results of research and development efforts or results of clinical trials
indicate a requirement for increased funding;
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- termination or alteration of our Cholestagel collaboration with Sankyo,
or a decision by Sankyo not to exercise its option to license our second
generation cholesterol-lowering product;
- termination or alteration of our agreements with the University of
Florida, Warner-Lambert, Schein or Nippon Kayaku;
- increases in, or interruptions in the supply of, special materials
required for the manufacture of products;
- competitive technological advances;
- additional funding is required in connection with the FDA review or other
regulatory processes and other factors; or
- termination of our Renagel joint venture.
Adequate additional funds, whether through additional sales of securities
or collaborative or other arrangements with corporate partners or from other
sources, may not be available when needed or on terms acceptable to us.
Insufficient funds may require us to delay, scale back or eliminate certain of
our research and product development programs, or license third parties to
commercialize products or technologies under terms that we might otherwise find
unacceptable. If required additional funding is not obtained, our business and
operating results would be adversely affected.
UNCERTAINTY OF MANUFACTURING AND SUPPLY RELATIONSHIPS MAY AFFECT OUR ABILITY TO
PRODUCE AND SELL PRODUCTS
Our company and our Renagel joint venture with Genzyme have relied and will
continue to rely upon third parties to manufacture commercial quantities of
Renagel. Our company and our Renagel joint venture currently have or are in the
process of negotiating the following manufacturing or supply relationships
related to Renagel:
- We have non-exclusively sublicensed our rights to manufacture the
starting material for Renagel to a supplier, and have recently entered
into a long-term fixed-price supply agreement to purchase the starting
material from this supplier;
- We have entered into a long-term fixed price supply agreement with The
Dow Chemical Company for the active ingredient for Renagel;
- Our Renagel joint venture with Genzyme has entered into a long-term fixed
price supply agreement with Genzyme to manufacture the active ingredient
for Renagel;
- We have concluded a long-term fixed price service agreement with one
encapsulator to formulate the Renagel active ingredient into finished
Renagel capsules for distribution into the United States, and we are
currently negotiating a long-term fixed price service agreement with the
same encapsulator to formulate the Renagel active ingredient into
finished Renagel capsules for distribution into other territories; and
- We are in the process of negotiating a long-term fixed price service
agreement with a tabulator to formulate the Renagel active ingredient
into finished Renagel tablets.
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With respect to Cholestagel, we currently have or are in the process of
negotiating the following manufacturing or supply relationships:
- We have non-exclusively sublicensed our rights to manufacture the
starting material for Cholestagel to a supplier, and have recently
entered into a long-term fixed-price supply agreement to purchase the
starting material from this supplier;
- We have entered into a supply agreement related to the supply of initial
commercial quantities of the active ingredient for Cholestagel, and are
beginning negotiations regarding a long-term supply agreement for
commercial quantities of the active ingredient for Cholestagel; and
- We are in the process of negotiating a long-term fixed price service
agreement with a formulator to formulate the Cholestagel active
ingredient into finished Cholestagel tablets.
Should any of these manufacturing relationships or negotiations terminate
or should any of the suppliers be unable to satisfy our requirements for
starting material, active ingredients or finished goods, we would be unable to
commercialize our products as expected, and our business and financial condition
would be materially and adversely affected. In addition, we have agreed to
supply the Cholestagel active ingredient and Cholestagel finished goods to
Sankyo at fixed prices. We cannot assure that our suppliers of Cholestagel
active ingredient or Cholestagel finished product will be able to deliver
materials to us at the same fixed prices. To the extent our suppliers are not
able to satisfy our requirements for Cholestagel active ingredient or finished
product at such prices, our results of operations would be materially adversely
affected. In addition, we cannot assure that we will be successful in obtaining
additional sources for any of the products or services described above or that
we will be able to obtain such products or services on commercially reasonable
terms.
We will also rely on third parties for the production of polyamine analogue
compounds or iron chelators in limited quantities for our pre-clinical and
clinical trials and do not at the present time possess the staff or facilities
necessary to manufacture these compounds in commercial quantities. We cannot
ensure that we or our suppliers can manufacture the polyamine analogue compounds
or iron chelators at a cost or in quantities necessary to make these compounds
commercially viable products. We may utilize existing relationships with
manufacturers of our compounds and could be materially adversely affected by
delays or interruptions in supply of polyamine analogue compounds or iron
chelators.
A shutdown in any of the manufacturing facilities utilized by our suppliers
due to technical, regulatory or other problems, resulting in an interruption in
supply of products, could significantly delay the manufacturing of one or more
of our products, which could have an adverse impact on our financial results.
The manufacturing process for pharmaceutical products is highly regulated, and
regulators may shut down manufacturing facilities that they believe do not
comply with regulations. The FDA's current Good Manufacturing Practices are
extensive regulations governing manufacturing processes, stability testing,
record-keeping and quality standards. Because the suppliers of key components
and materials must be named in an NDA filed with the FDA for a product,
significant delays can occur if the qualification of a new supplier is required.
In the event of any interruption in supply from a contract manufacturer due to
regulatory reasons, processing problems, capacity constraints or other causes,
alternative manufacturing arrangements may not be available to us on a timely
basis, if at all.
WE RELY ON LICENSES FROM THIRD PARTIES FOR ACCESS TO MATERIALS AND TECHNOLOGIES,
AND FAILURE TO MAINTAIN THESE LICENSES WOULD NEGATIVELY IMPACT US
We have obtained a non-exclusive license from the third party which has
patents covering the starting material employed in the manufacture of Renagel
and Cholestagel. We may not sublicense
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our rights under this license without the licensor's consent, except to our
current supplier of the starting material and certain other parties specified in
the license. The license agreement may be terminated upon short notice if we
fail to meet our material obligations under the license agreement, including
lump sum payments, royalties and confidentiality obligations. If the license is
terminated and the owner of the patent is unwilling to supply material to us, we
may not be able to commercialize our lead products using current manufacturing
procedures, if at all, which would have a material adverse effect on our
financial condition and results of operations.
We also license significant technology from the University of Florida, and
exclusively license more than 45 issued U.S. and foreign patents and numerous
pending patent applications, subject to the nonexclusive statutory U.S.
government license.
The University of Florida may terminate our rights under this license
agreement under certain circumstances, including our:
- failure to pay royalties as required;
- material breach of the license agreement;
- bankruptcy or failure to carry on our business;
- failure to commence marketing of a licensed product within six months of
approval in any specific market; and
- failure to comply with the terms of our sponsored research agreement with
the University of Florida.
To date, no licensed products under the agreement have received marketing
approvals in any specific market. If the University of Florida terminates the
license agreement, our rights to manufacture and market DEHOP, DENSPM and
certain other potential products would terminate, and our financial condition
and results of operations could be materially adversely affected.
OUR OPERATIONS DEPEND ON COMPLIANCE WITH COMPLEX GOVERNMENT REGULATIONS
Government authorities in the U.S. and other countries, including the FDA,
extensively regulate our research, pre-clinical development, clinical trials,
and the manufacturing and marketing of products under development. To obtain
approval to commercialize a product, we must demonstrate to the satisfaction of
these authorities that a product is safe and effective for its intended uses,
and that the product can be manufactured to the applicable standards. In the
U.S. and other countries, the product must also undergo extensive pre-clinical
testing. To date, we have received only U.S. regulatory approval to market
Renagel capsules. Delays in obtaining additional regulatory approvals could
adversely affect the marketing of products we develop and our ability to
generate commercial product revenues.
Whether or not FDA approval has been obtained, approval of a product by
regulatory authorities in most foreign countries must be obtained prior to the
commencement of commercial sales of the product in these countries. The
requirements governing the conduct of clinical trials and product approvals vary
widely from country to country, and the time required for approval may be longer
or shorter than that required for FDA approval. Although there are some
procedures for unified filings in the European Union, in general, each country
at this time has its own procedures and requirements. Further, the FDA regulates
the export of products produced in the U.S. and may prohibit the export even if
such products are approved for sale in other countries.
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We are subject to numerous environmental, health, and workplace safety laws
and regulations, including those governing laboratory procedures and the
handling of biohazardous materials. Any violation of, and cost of compliance
with, these laws and regulations could adversely affect our operations.
The effects of governmental regulation will have considerable effect on the
development of our products including:
- The regulatory process includes pre-clinical studies and clinical trials
of each product to establish its safety and efficacy, and may include
post-marketing studies that require expenditure of substantial resources.
- The results for pre-clinical studies and early clinical trials that we
conduct may not be predictive of results obtained in later clinical
trials, and there can be no assurance that clinical trials conducted by
us will demonstrate sufficient safety and efficacy to obtain marketing
approvals.
- The rate of completion of our clinical trials may be delayed by many
factors, including slower than anticipated patient enrollment or adverse
events occurring during the clinical trials.
- Data obtained from pre-clinical and clinical activities are susceptible
to varying interpretations, which could delay, limit or prevent
regulatory approval. In addition, delays or rejections may be encountered
based upon many factors, including changes in regulatory policy during
the period of product development.
- As a result of FDA reviews or complications that may arise in any phase
of the clinical trial program, the proposed schedules for IND, IDE and
clinical protocol submissions to the FDA, initiations of studies and
completions of clinical trials may not be maintained.
We cannot assure that we will have sufficient resources to complete
regulatory processes or that we could survive the inability to obtain, or delays
in obtaining, those approvals. Regulatory authorities may decide at any time to
review any approvals they may have previously granted, and their later discovery
of previously unknown problems may result in withdrawal of products from the
market. Failure to comply with applicable regulatory requirements can result in
fines, suspensions of regulatory approvals, product recalls, operating
restrictions and criminal prosecution. Further, authorities may establish
additional regulations that could prevent or delay regulatory approval of and/or
limit federal government reimbursement for our products.
WE FACE INTENSE COMPETITION FROM OTHER COMPANIES WHOSE PRODUCTS MAY GAIN GREATER
MARKET ACCEPTANCE
The pharmaceutical industry is intensely competitive and is subject to
rapid and significant technological change. Many companies, including
biotechnology, chemical and pharmaceutical companies, are actively engaged in
activities similar to ours, including research and development of products for
the treatment of hyperphosphatemia, hypercholesterolemia, obesity, infectious
diseases, cancer and AIDs related diarrhea. For example, in addition to Renagel
capsules, there are several other phosphate binders available or under
development. A prescription calcium acetate preparation is currently the only
other product approved in the U.S. for the treatment of elevated phosphorus
levels in patients with end-stage renal disease. Other products currently used
as phosphate binders include over-the-counter calcium- and aluminum-based
products and dietary calcium supplements.
In the cholesterol reduction field, products are currently available that
address many of the needs of the market. These products include other bile acid
sequestrants, HMG-CoA reductase inhibitors,
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fibric acid derivatives and niacin products. In 1998, sales of HMG-CoA reductase
inhibitors represented approximately 97% of the market for cholesterol-reducing
drugs sold in the U.S. Currently marketed products often have a significant
competitive advantage over new products such as those which we may introduce,
and we cannot assure that our products will be able to compete successfully with
existing therapies or will achieve market acceptance. Our success depends upon
developing and maintaining a competitive position in the development of products
and technologies in our areas of focus. Failure to achieve these objectives will
adversely affect our ability to achieve and sustain profitability.
We cannot assure that respective competitors will not succeed in developing
technologies and products that are more effective than any which we are
developing or anticipate developing, which would render our technology and
products obsolete or noncompetitive. Many of these competitors have
substantially greater financial and technical resources, larger research and
development staffs and more extensive marketing and manufacturing capabilities
than we or our partners have, and certain of these competitors may compete with
us in establishing development and marketing agreements with pharmaceutical
companies. In addition, many of our competitors have greater experience in
conducting pre-clinical testing and human clinical trials and obtaining FDA and
other regulatory approvals. Our competitors may succeed in obtaining FDA
approval for competitive products more rapidly than us.
PATENTS AND PROPRIETARY TECHNOLOGY MAY BE DIFFICULT TO OBTAIN OR INEFFECTIVE,
ALLOWING OTHER COMPANIES TO MORE EASILY PRODUCE PRODUCTS SIMILAR TO OUR PRODUCTS
The biotechnology and pharmaceutical industries place considerable
importance on obtaining patent and trade secret protection for new technologies,
products and processes. Our success will depend, in part, on our ability to
obtain patent protection for our manufacturing processes and products (including
the use of our products), preserve our trade secrets and operate without
infringing the proprietary rights of third parties. We have ongoing research
efforts and expect to seek additional patents covering this research in the
future. We cannot assure our success or timeliness in obtaining any patents. We
cannot assure that patent applications relating to our potential products or
technology will result in patents being issued or that any current or future
patents will provide us with substantial protection or commercial benefit,
afford us adequate protection from competing products, or not be challenged,
invalidated or infringed. Furthermore, we cannot assure that others will not
independently develop similar products and processes, duplicate any of our
products or design around any current or our future patents. With respect to
patents licensed from the University of Florida, the U.S. government has funded
certain activities related to certain of such patents and therefore, it retains
a non-exclusive license to inventions made under grants from the National
Institutes of Health, or NIH. As a non-exclusive licensee of certain of the
University of Florida patents, the U.S. government could increase the supply of
products based on the patents or reduce the cost of treatment with the products,
should the government exercise its non-exclusive rights. Any of these actions
could materially and adversely affect our operations related to technology
licensed from the University of Florida.
We possess important proprietary trade secrets and unpatented know-how. We
cannot assure that others may not independently develop the same or similar
technologies. Although we have taken steps to protect these technologies, third
parties may gain access to them.
In addition, we may be required to obtain licenses to patents or other
proprietary rights of third parties. We cannot assure that any licenses required
under any such patents or proprietary rights would be made available on terms
acceptable to us, if at all. If we do not obtain such licenses, we could
encounter delays in product market introductions while we attempt to design
around such
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patents or other rights, or we may be unable to develop, manufacture or sell
such products. We also seek to protect our proprietary technology, including
technology which may not be patented or patentable, in part by confidentiality
agreements and, if possible, inventions rights agreements with our
collaborators, advisors, employees and consultants. We cannot assure that these
agreements will not be breached, that we will have adequate remedies for any
breach or that our trade secrets will not otherwise be disclosed to, or
discovered by, competitors. We cannot assure that such persons or institutions
will not assert rights to intellectual property arising out of their
relationships with us.
Significant litigation has been conducted in the biotechnology and
pharmaceutical industry regarding patents and other proprietary rights. We could
incur substantial costs in defending our company in suits brought against us or
in suits in which we may assert our patents against others. If the outcome of
any such litigation is unfavorable to us, our business could be materially and
adversely affected. To determine the priority of inventions, we may also have to
participate in interference proceedings declared by the U.S. Patent and
Trademark Office, which could result in adverse decisions and substantial cost
to us. If we become involved in similar litigation on its intellectual property
rights, we would be materially adversely effected.
PRODUCT LIABILITY CLAIMS MAY INCREASE COSTS AND DECREASE PROFITS
Our business exposes us to potential product liability claims, which are
inherent in the testing, manufacturing, marketing and sale of pharmaceuticals.
The use of our product candidates in clinical trials also exposes us to product
liability claims and possible adverse publicity. These risks increase with
respect to our product candidates, if any, that receive regulatory approval for
commercialization. We currently have limited product liability insurance
coverage for the clinical research use of our product candidates, and have
product liability coverage for the commercial sale of Renagel. However, we
cannot assure that we will be able to obtain additional insurance coverage for
our other products which may be commercialized in the future on acceptable
terms, if at all, or that a product liability claim would not materially
adversely affect our business. It is possible that a single product liability
claim could exceed our insurance coverage limits, and multiple claims are
possible. If that happens, our insurance coverage may not be adequate, and in
the future such insurance may not be renewed at an acceptable cost, if at all.
Our business, financial condition and results of operations could be materially
and adversely affected by one or more successful product liability claims.
PHARMACEUTICAL PRICING AND REIMBURSEMENT PROCEDURES MAY AFFECT OUR FINANCIAL
PERFORMANCE
In both domestic and foreign markets, our or our corporate partners'
ability to commercialize our products may depend on whether government health
administration authorities, private health insurers and others provide for
reimbursement of the costs of these products and related treatments and other
organizations. Third party payors are increasingly challenging the price and
cost effectiveness of medical products. We cannot assure that these third party
payors will consider our proposed products cost effective or that third party
payors will adequately reimburse us or our corporate partners to allow for an
appropriate return on our investment in product development. If the government
and third party payors do not provide adequate coverage and reimbursement levels
for use of our therapeutic products, the market acceptance of these products and
our financial performance would be adversely affected. This is particularly true
with respect to Renagel, which competes with certain low-priced,
over-the-counter products.
Healthcare reform, in particular, may have a significant impact on any of
our products under development. Any reform measures, if adopted, could adversely
affect the pricing of therapeutic products in the U.S. or the amount of
reimbursement available from U.S. agencies or third party
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insurers and could materially and adversely affect us in general. Also, our
ability to commercialize some of our potential products may be adversely
affected if these proposals materially and adversely affect the business,
financial condition and profitability of prospective collaborators for certain
of our proposed products. Legislation and regulations affecting the pricing of
pharmaceuticals may change before any of our proposed products are approved for
marketing. Adoption of legislation or regulations could further limit
reimbursement.
In addition, in many international markets, governments control the prices
of prescription pharmaceuticals. In these markets, once marketing approval is
received, pricing negotiation can take another six to twelve months or longer.
We may be forced to lower prices by competing product sales, and attempts to
gain market share or introductory pricing programs, which could adversely affect
our business, financial condition and results of operations.
OUR FAILURE TO CONTINUE TO HIRE AND RETAIN QUALIFIED PERSONNEL COULD HARM OUR
BUSINESS
We are highly dependent on the members of our management and scientific
staff. The loss of one or more of our qualified personnel or consultants could
have a material adverse effect on us. In addition, we believe that our future
success will depend in large part upon our ability to attract and retain highly
skilled scientific and managerial personnel. We face significant competition for
such personnel from other companies, research and academic institutions,
government entities and other organizations. We cannot assure that we will be
successful in hiring or retaining the personnel we require for continued growth.
The failure to hire and retain such personnel could materially and adversely
affect us.
POTENTIAL YEAR 2000 PROBLEMS MAY AFFECT US
While no significant business interruption has occurred since January 1,
2000, we expect to continue to monitor our systems for year 2000 compliance
issues that may still occur. We cannot assure that business interruptions will
not occur related to year 2000 compliance. In addition, the inability of a third
party upon which we are dependent to address issues related to year 2000
compliance could have a material adverse effect on our business, financial
condition, and results of operations.
VOLATILITY OF STOCK PRICE
The market price of the common stock, like that of the securities of many
other biopharmaceutical companies, has been and is likely to continue to be
highly volatile. The stock market has experienced significant price and volume
fluctuations that are often unrelated to the operating performance of particular
companies. Factors contributing to such volatility include:
- results of pre-clinical studies and clinical trials by us or our
competitors;
- other evidence of the safety or efficacy of our pharmaceutical products
or that of our competitors;
- announcements of new collaborations;
- announcements of our technological innovations or new therapeutic
products or that of our competitors;
- governmental regulation;
- healthcare legislation; and
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- developments in our patent or other proprietary rights or that of our
competitors, including litigation.
Fluctuations in our operating results and market conditions for
biotechnology stocks in general could have a significant impact on the
volatility of the market price for the common stock and on the future price of
the common stock.
ANTI-TAKEOVER DEFENSE PROVISIONS MAY DETER POTENTIAL ACQUIRORS OF OUR COMPANY
AND MAY DEPRESS OUR STOCK PRICE
Certain provisions of our restated certificate of incorporation and by-laws
and the terms of our stockholder rights plan may have the effect of delaying or
preventing a change in control of our company and may deprive stockholders of
the opportunity to receive a premium for their GelTex common stock. In addition,
our authorized capital stock includes shares of undesignated preferred stock
that may be issued from time to time by our board of directors in one or more
series. The issuance of series preferred stock could have the effect of
discouraging attempts to acquire control of our company.
In addition, under our stockholder rights plan, holders of our common stock
are entitled to one preferred share purchase right for each outstanding share of
GelTex common stock they hold, exercisable under certain defined circumstances
involving a potential change of control. The preferred share purchase rights
have the anti-takeover effect of causing substantial dilution to a person or
group that attempts to acquire our company on terms not approved by our board of
directors. The foregoing provisions could have a material adverse effect on the
premium that potential acquirors might be willing to pay in a merger or that
investors might be willing to pay in the future for shares of our common stock.
WE HAVE NO INTENTION TO PAY DIVIDENDS
We have never paid any cash dividends on GelTex common stock. We currently
intend to retain all future earnings, if any, for use in our business and do not
expect to pay any dividends in the foreseeable future.
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FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference contain
forward-looking statements within the meaning of Section 27A of the Securities
Act and Section 21E of the Exchange Act. These statements can be identified by
the use of forward-looking terminology such as "may," "will," "could," "expect,"
"anticipate," "estimate," "continue" or other similar words. These statements
discuss future expectations, contain projections of results of operations or of
financial condition or state trends and known uncertainties or other
forward-looking information. Examples of forward-looking statements can be found
in the discussion set forth under "Management's Discussion and Analysis of
Financial Condition and Results of Operations" in our Annual Report on Form 10-K
for the fiscal year ended December 31, 1998 and under "Business" in the Form
10-K and in our 10-Qs for the quarters ended September 30, 1999, June 30, 1999
and March 31, 1999, each incorporated in this prospectus by reference. Such
statements are based on current expectations that involve a number of
uncertainties including those set forth in the risk factors above. When
considering forward-looking statements, you should keep in mind that the risk
factors noted above and other factors noted throughout this prospectus or
incorporated by reference could cause our actual results to differ significantly
from those contained in any forward-looking statement. We undertake no
obligation to publicly revise these forward-looking statements to reflect events
or circumstances that arise after the date hereof.
USE OF PROCEEDS
We would receive approximately $7,037,105.40 in net proceeds if all of the
options and warrants were exercised. We currently intend to use the net proceeds
from any exercises as working capital. Depending on our circumstances at the
time any or all of the net proceeds from the exercise of an option or warrant
become available, if at all, we reserve the right to use the net proceeds for
purposes other than working capital.
PLAN OF DISTRIBUTION
The shares of GelTex common stock issuable upon exercise of the options and
warrants are being offered directly by us pursuant to the terms of the options
and warrants. No underwriter is being utilized in connection with the offering
of the shares underlying the options and warrants.
In order to facilitate the exercise of the options and warrants, we will
furnish, at our expense, such number of copies of this Prospectus to each
recordholder of options and/or warrants as the holder may request, together with
instructions that such copies be delivered to the beneficial owners thereof. The
shares will be offered on the Nasdaq National Market.
In connection with our acquisition of SunPharm Corporation, formerly a
public company, and pursuant to the Agreement and Plan of Merger by and among
our company, Shine Acquisition Sub, Inc. and SunPharm Corporation dated August
13, 1999, or the merger agreement, we agreed to assume certain outstanding
options and warrants issued by SunPharm Corporation, or SunPharm. At the
effective time of the merger, 9:00 a.m., November 16, 1999, each outstanding
SunPharm option and warrant was converted into a right to purchase shares of
GelTex common stock. An aggregate of 51,271 shares of GelTex common stock would
be issuable for an aggregate offering price of approximately $1,682,300 if all
of the options were exercised. An aggregate of 196,086 shares of GelTex common
stock would be issuable for an aggregate offering price of approximately
$5,354,805 if all of the warrants were exercised.
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<PAGE> 15
The exercise price and other terms of the options and warrants were
determined by negotiations between SunPharm and the individual option and
warrant holders and may not necessarily bear any relationship to our assets,
results of operations or other generally accepted criteria of value.
We will bear the expense of preparation and filing of the registration
statement of which this prospectus is a part. The aggregate amount of all these
expenses is expected to be approximately $44,331.57.
We have agreed pursuant to the merger agreement to keep the registration
statement of which this prospectus constitutes a part effective while any of the
options assumed by us remain outstanding, and if there are no assumed options
outstanding, until the earlier of (i) November 16, 2001 and (ii) the date upon
which none of the warrants remain exercisable.
LEGALITY OF COMMON STOCK
The validity of the securities offered in this prospectus is being passed
upon for us by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston,
Massachusetts. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., attorneys of
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. and certain members of their
families and trusts for their benefit own an aggregate of approximately 1,000
shares of our common stock.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements included in our Current Report on Form 8-K dated March 6,
2000, as set forth in their report, which is incorporated by reference in this
prospectus and elsewhere in the registration statement. Our financial statements
are incorporated by reference in reliance on Ernst & Young LLP's report, given
on their authority as experts in accounting and auditing.
The financial statements of RenaGel LLC as of December 31, 1999 and 1998
and for each of the two years in the period ended December 31, 1999 incorporated
by reference in this prospectus and elsewhere in the registration statement by
reference to GelTex's Current Report on Form 8-K for the year ended December 31,
1999 and have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP, independent accountants, given on the authority of
said firm as experts in auditing and accounting.
The financial statements of SunPharm (a development stage company) as of
December 31, 1998 and 1997 and for the period from May 3, 1990 to December 31,
1998, except for the period from May 3, 1990 to December 31, 1994 which were
audited by other auditors, included in this prospectus and elsewhere in the
registration statement have been audited by Deloitte & Touche LLP, independent
auditors, as stated in their report appearing herein and elsewhere in the
registration statement, and have been so included in reliance upon the reports
of such firm upon their authority as experts in accounting and auditing.
MATERIAL CHANGES
We incorporate by reference our registration statement on Form S-4 filed
with the SEC on October 5, 1999 (File No. 333-88459).
INDEMNIFICATION
Section 145 of the General Corporation Law of the State of Delaware
provides that we have the power to indemnify our directors, officers, employees
or agents and certain other persons serving at our request in related capacities
against amounts paid and expenses incurred in connection with an
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action or proceeding to which he or she is or is threatened to be made a party
by reason of such position, if such person shall have acted in good faith and in
a manner he reasonably believed to be in or not opposed to our best interests,
and, in any criminal proceeding, if such person had no reasonable cause to
believe his conduct was unlawful, provided that, in the case of actions brought
by or on behalf of us, no indemnification shall be made with respect to any
matter as to which such person shall have been adjudged to be liable to us
unless and only to the extent that the adjudicating court determines that such
indemnification is proper under the circumstances.
Section 102(b)(7) of the Delaware General Corporation Law permits us to
provide in our certificate of incorporation that our directors shall not be
personally liable to us or our stockholders for monetary damages for breach of
fiduciary duty as a director, except for liability (i) for any breach of the
director's duty of loyalty to the corporation or its stockholders, (ii) for acts
or omissions not in good faith or which involve intentional misconduct or a
knowing violation of law, (iii) under Section 174 of the Delaware General
Corporation Law, or (iv) for any transaction from which the director derived an
improper personal benefit.
Our Restated Certificate of Incorporation also provides, as permitted by
Delaware law, that directors shall not be personally liable to us or our
stockholders for monetary damages for breach of fiduciary duty as a director,
except for liability (i) for any breach of a director's duty of loyalty to the
Company or its stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or knowing violations of law, (iii) under
Section 174 of the Delaware General Corporation Law or (iv) for any transaction
from which the director derived an improper personal benefit.
We have a Directors and Officers liability insurance policy that insures
our officers and directors against certain liabilities.
COMMISSION POLICY
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers or persons controlling us, we have been
informed that in the opinion of the SEC such indemnification is against public
policy as expressed in the Securities Act and is therefore unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We are a public company and file annual, quarterly and special reports,
proxy statements and other information with the Securities and Exchange
Commission. You may read and copy any document we file at the SEC's Public
Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. You can
request copies of these documents by writing to the SEC and paying a fee for the
copying cost. Please call the SEC at 1-800-SEC-0330 for more information about
the operation of the public reference room. Our SEC filings are also available
to the public at the SEC's web site at "http://www.sec.gov." In addition, our
stock is listed for trading on the Nasdaq National Market. You can read and copy
reports and other information concerning us at the offices of the National
Association of Securities Dealers, Inc. located at 1735 K Street, Washington,
D.C. 20006.
This prospectus is only part of a Registration Statement on Form S-3 that
we have filed with the SEC under the Securities Act of 1933 and therefore omits
certain information contained in the Registration Statement. We have also filed
exhibits and schedules with the Registration Statement
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that are excluded from this prospectus, and you should refer to the applicable
exhibit or schedule for a complete description of any statement referring to any
contract or other document. You may:
- inspect a copy of the Registration Statement, including the exhibits and
schedules, without charge at the public reference room or
- obtain a copy from the SEC upon payment of the fees prescribed by the
SEC.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to "incorporate by reference" the information we file
with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
considered to be a part of this prospectus and information that we file later
with the SEC will automatically update and supersede this information. We
incorporate by reference the documents listed below and any future filings made
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act of 1934 until the earlier of (i) January , 2002 or (ii) the sale of all of
the shares of common stock. The documents we are incorporating by reference are:
- Our Annual Report on Form 10-K for the fiscal year ended December 31,
1998, filed on March 31, 1999 (except for Exhibit 99.1);
- Our Quarterly Report on Form 10-Q for the quarter ended September 30,
1999, filed on November 12, 1999;
- Our Quarterly Report on Form 10-Q for the quarter ended June 30, 1999,
filed on August 16, 1999;
- Our Quarterly Report on Form 10-Q for the quarter ended March 31, 1999,
filed on May 14, 1999;
- Our Current Report on Form 8-K, filed with the SEC on March 6, 2000.
- Our Current Report on Form 8-K, filed with the SEC on December 1, 1999;
- Our Current Report on Form 8-K, filed with the SEC on November 15, 1999;
- The description of our capital stock contained in our Registration
Statement on Form 8-A under the 1934 Act as filed with the SEC on
September 26, 1995, and as amended on October 12, 1995, including
amendments or reports filed for the purpose of updating that description;
and
- The description of Junior Participating Preferred Stock Purchase Rights
contained in our Registration Statement on Form 8-A filed with the SEC on
March 5, 1996.
You may request a copy of these filings at no cost by writing or
telephoning our Chief Financial Officer at the following address and phone
number:
GelTex Pharmaceuticals, Inc.
153 Second Avenue
Waltham, Massachusetts 02451
(781) 290-5888
This prospectus is part of a Registration Statement that we filed with the
SEC. You should rely only on the information incorporated by reference in or
provided in this prospectus and the
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Registration Statement. We have not authorized any other person to provide you
with different information. We are not making an offer of these securities in
any state where the offer is not permitted. You should not assume that the
information in this prospectus is accurate as of any date other than the date on
the front of this document.
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YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE HAVE
NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION DIFFERENT FROM THAT
CONTAINED IN THIS PROSPECTUS. WE ARE OFFERING TO SELL AND SEEKING OFFERS TO BUY
SHARES OF OUR COMMON STOCK ONLY IN JURISDICTIONS WHERE OFFERS AND SALES ARE
PERMITTED. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS ACCURATE ONLY AS OF
FEBRUARY, 2000. YOU SHOULD NOT ASSUME THAT THIS PROSPECTUS IS ACCURATE AS OF ANY
OTHER DATE.
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TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
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<S> <C>
The Company......................... 2
Risk Factors........................ 3
Forward-Looking Statements.......... 14
Use of Proceeds..................... 14
Plan of Distribution................ 14
Legality of Common Stock............ 15
Experts............................. 15
Material Changes.................... 15
Indemnification..................... 15
Where You Can Find More
Information....................... 16
Incorporation of Documents by
Reference......................... 17
</TABLE>
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247,357 SHARES OF COMMON STOCK,
$.01 PAR VALUE PER SHARE
GELTEX PHARMACEUTICALS, INC.
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PROSPECTUS
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