<PAGE>
PROSPECTUS
1,472,147 SHARES
CV THERAPEUTICS, INC.
------------
COMMON STOCK
------------
This Prospectus relates to 1,472,147 shares of Common Stock (the
"Shares"), with a par value of $0.001 (the "Common Stock") of CV
Therapeutics, Inc. (the "Company" or "CVT") which may be offered and sold by
certain stockholders of the Company (the "Selling Securityholders"). Of such
shares, 75,000 were issued by the Company pursuant to an Amendment to License
Agreement by and between the Company and Syntex (U.S.A.), Inc., dated as of
July 3, 1997 (the "License Agreement") and 1,397,147 were issued by the
Company pursuant to a Common Stock Purchase Agreement by and between the
Company and Biotech Target S.A., dated as of October 7, 1997 (the "Private
Placement Agreement").
The Shares may be offered by the Selling Securityholders from time to
time in transactions on the Nasdaq National Market System, in privately
negotiated transactions or a combination of such methods of sale, at fixed
prices that may be changed, at market prices prevailing at the time of sale,
at prices related to such prevailing market prices or at negotiated prices.
The Selling Securityholders may effect such transactions by selling the
Shares to or through broker-dealers, and such broker-dealers may receive
compensation in the form of discounts, concessions or commissions from the
Selling Securityholders or the purchasers of the Shares for whom such
broker-dealers may act as agent or to whom they sell as principal or both
(which compensation to a particular broker-dealer might be in excess of
customary commissions). See "Selling Securityholders" and "Plan of
Distribution."
The Company will not receive any of the proceeds from the sale of the
Shares by the Selling Securityholders hereof. See "Plan of Distribution."
The Selling Securityholders, directly or through agents, dealers or
underwriters, may sell the Shares offered hereby from time to time on terms
to be determined at the time of sale. The Company's Common Stock is traded
on the Nasdaq National Market System under the symbol CVTX.
------------
THE SHARES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" ON PAGES 5-12.
------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION NOR HAS THE SECURITIES AND EXCHANGE COMMISSION
OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY
REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
No underwriting commissions or discounts will be paid by the Company in
connection with this offering. Estimated expenses payable by the Company in
connection with this offering are $27,296. The aggregate proceeds to the
Selling Securityholders from the sale of the Shares will be the purchase
price of the Shares sold less the aggregate agents' commissions and
underwriters' discounts, if any, and other expenses of issuance and
distribution not borne by the Company. See "Plan of Distribution."
The Selling Securityholders and any broker-dealers, agents or
underwriters that participate with the Selling Securityholders in the
distribution of the Shares may be deemed to be "underwriters" within the
meaning of the Securities Act of 1933, as amended (the "Act"), and any
commission received by them and any profit on the resale of the Shares
purchased by them may be deemed to be underwriting commissions or discounts
under the Act. The Company has agreed to indemnify certain of the Selling
Securityholders and certain other persons against certain liabilities,
including liabilities under the Act.
The date of this Prospectus is December 9, 1997.
<PAGE>
No person is authorized in connection with any offering made hereby to
give any information or to make any representation not contained or
incorporated by reference in this Prospectus, and any information or
representation not contained or incorporated herein must not be relied upon
as having been authorized by the Company. This Prospectus does not constitute
an offer to sell, or a solicitation of an offer to buy, by any person in any
jurisdiction in which it is unlawful for such person to make such offer or
solicitation. Neither the delivery of this Prospectus at any time nor any
sale made hereunder shall, under any circumstances, imply that the
information herein is correct as of any date subsequent to the date hereof.
AVAILABLE INFORMATION
The Company is subject to the informational reporting requirements of
the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith files reports, proxy statements and other information
with the Securities and Exchange Commission (the "Commission"). Such reports,
proxy statements and other information can be inspected and copied at the
public reference facilities maintained by the Commission at Room 1024, 450
Fifth Street, N.W., Judiciary Plaza, Washington, D.C. 20549, and at the
Commission's following Regional Offices: Chicago Regional Office, Citicorp
Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511;
and New York Regional Office, 7 World Trade Center, Suite 1300, New York, New
York 10048. Copies of such material can be obtained at prescribed rates from
the Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Judiciary Plaza, Washington, D.C. 20549. The Commission maintains a Web site
that contains reports, proxy and information statements and other information
regarding registrants that file electronically with the Commission. The
address of such Web site is http://www.sec.gov.
Additional information regarding the Company and the Shares offered
hereby is contained in the Registration Statement on Form S-3 and the
exhibits thereto filed with the Commission under the Act. This Prospectus
does not contain all of the information contained in such Registration
Statement and the exhibits thereto. Statements contained in this Prospectus
regarding the contents of any document or contract may be incomplete and, in
each instance, reference is made to the copy of such contract or document
filed as an exhibit to the Registration Statement. For further information
pertaining to the Company and the Shares, reference is made to the
Registration Statement and the exhibits thereto, which may be inspected
without charge at, and copies thereof may be obtained at prescribed rates
from, the office of the Commission at 450 Fifth Street, N.W., Judiciary
Plaza, Washington, D.C. 20549.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by the Company with the Commission
pursuant to the Exchange Act are by this reference incorporated in and made a
part of this Prospectus:
(1) The Annual Report on Form 10-K for the fiscal year ended December 31,
1996, filed on March 28, 1997, as amended on Form 10-K/A filed on April
25, 1997, including all matters incorporated by reference therein;
(2) The Proxy Statement for the Company's 1997 Annual Meeting of
Stockholders, filed on May 15, 1997, including all matters incorporated
by reference therein;
(3) The Quarterly Reports on Form 10-Q for the fiscal quarters ended March
31, 1997, June 30, 1997 and September 30, 1997, including all matters
incorporated by reference therein; and
(4) The description of the Common Stock contained in the Company's
Registration Statement on Form 8-A filed on October 30, 1996.
All documents filed by the Company pursuant to Section 13(a), 13(c), 14
or 15(d) of the Exchange Act after the date of this Prospectus and prior to
the termination of the offering shall be deemed to be incorporated by
reference herein and to be a part of this Prospectus from the date of filing
of such documents. Any statement contained in a document incorporated or
deemed to be incorporated by reference herein shall be deemed to be modified
or superseded for purposes of this Prospectus to the extent that a statement
contained herein or in any other subsequently filed document which also is or
is deemed to be incorporated by reference herein modifies or supersedes such
statement. Any such statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute a part of this Prospectus.
2.
<PAGE>
Copies of all documents which are incorporated herein by reference (not
including the exhibits to such documents, unless such exhibits are
specifically incorporated by reference into such documents or into this
Prospectus) will be provided without charge to each person, including any
beneficial owner to whom this Prospectus is delivered, upon a written or oral
request to CV Therapeutics, Inc., Attention: Investor Relations, 3172 Porter
Drive, Palo Alto, California, 94304, telephone number (415) 812-0585.
The discussions in this Prospectus and the documents incorporated by
reference herein contain forward-looking statements that involve risks and
uncertainties. The Company's actual results could differ materially from
those discussed herein and in such incorporated documents. Factors that
could cause or contribute to such differences include, but are not limited
to, those discussed under the heading "Risk Factors" herein, as well as those
discussed in the documents incorporated herein by reference.
------------
3.
<PAGE>
THE COMPANY
THE FOLLOWING SUMMARY IS QUALIFIED IN ITS ENTIRETY BY THE MORE DETAILED
INFORMATION AND FINANCIAL STATEMENTS APPEARING ELSEWHERE HEREIN OR
INCORPORATED BY REFERENCE IN THIS PROSPECTUS.
CVT is a biopharmaceutical company focused exclusively on the
application of molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment of chronic
cardiovascular diseases.
CVT was incorporated in Delaware in December 1990. The Company's
executive offices are located at 3172 Porter Drive, Palo Alto, California
94304, and its telephone number is (415) 812-0585.
THE OFFERING
Shares offered ............ Up to 1,472,147 Shares, all of which are
being offered by the Selling Securityholders.(1)
Use of Proceeds ........... The Company will not receive any of the proceeds
from the sale of the Shares by the Selling
Securityholders.
Nasdaq Symbol ............. CVTX.
- -------------
(1) The 1,472,147 shares of Common Stock were issued by the Company pursuant
to the License Agreement and the Private Placement Agreement.
USE OF PROCEEDS
The Company will not receive any of the proceeds from the sale of the
Shares by the Selling Securityholders.
DIVIDEND POLICY
The Company has never paid cash dividends. The Company's Board of
Directors currently intends to retain any earnings for use in the Company's
business and does not anticipate paying any cash dividends in the foreseeable
future.
This Prospectus includes trademarks and trade names of the Company and
certain other companies.
4.
<PAGE>
RISK FACTORS
AN INVESTMENT IN THE SHARES OF COMMON STOCK OFFERED HEREBY INVOLVES A
HIGH DEGREE OF RISK. PROSPECTIVE INVESTORS SHOULD CAREFULLY CONSIDER, IN
ADDITION TO THE OTHER INFORMATION CONTAINED IN THIS PROSPECTUS, THE FOLLOWING
RISK FACTORS IN EVALUATING THE COMPANY AND THE COMMON STOCK OFFERED HEREBY.
UNCERTAINTIES RELATED TO EARLY STAGE OF DEVELOPMENT
The Company is at an early stage of development and must be evaluated in
light of the uncertainties and complications present in an early stage
biopharmaceutical company. In addition, all of the Company's products are at
an early stage of development. Since the Company's inception in 1990,
substantially all of the Company's resources have been dedicated to research
and development, and the Company has not generated any product revenue.
Because all of the Company's potential products are in research, preclinical
or clinical development, product revenues will not be realized for at least
several years, if at all. Drug discovery methods based upon molecular
cardiology are relatively new, and there can be no assurance that the Company
will be able to employ these methods of drug discovery successfully or that
these methods will lead to the development of commercially viable
pharmaceutical products. Certain of the Company's compounds within the
Company's cell cycle and adenosine A1 receptor programs are in the early
stages of research and development, and the Company cannot predict when, if
ever, it will commence clinical trials for such new compounds. There can be
no assurance that any of the Company's product development efforts will be
successfully completed, that any of the Company's products will be proven to
be safe and effective, that regulatory approvals will be obtained at all or
be as broad as sought, that the Company's products will be capable of being
produced in commercial quantities or that any products, if introduced, will
achieve market acceptance.
UNCERTAINTIES RELATED TO CLINICAL TRIALS
The Company's potential products are subject to the risks of failure
inherent in the development of pharmaceutical products and will require
additional development, preclinical studies, clinical trials and regulatory
approval prior to commercialization. The results from preclinical studies and
early clinical trials may not be predictive of results obtained in later
clinical trials, and there can be no assurance that clinical trials conducted
by the Company or its collaborators will demonstrate sufficient safety and
efficacy to obtain the requisite approvals or that marketable products will
result. For example, in November 1995, based on unfavorable efficacy data
from a Phase II trial, the Company terminated its development program for the
CVT-1 product for treatment of primary hypercholesterolemia.
The Company currently has only two products in clinical development,
ranolazine and CVT-124. The rate of completion of the Company's clinical
trials may be delayed by many factors, including slower than anticipated
patient enrollment, difficulty in finding a sufficient number of patients
fitting the appropriate trial profile or difficulty in obtaining sufficient
supplies of clinical trial materials or adverse events occurring during the
clinical trials. Completion of testing, studies and trials may take several
years, and the length of time varies substantially with the type, complexity,
novelty and intended use of the product. There can be no assurance that the
Company's drug development efforts will progress as expected or that such
efforts will lead to the further development and regulatory approval of any
product. In addition, data obtained from preclinical and clinical activities
are susceptible to varying interpretations, which could delay, limit or
prevent regulatory approval. Delays or rejections may be encountered based
upon many factors, including changes in regulatory policy during the period
of product development. No assurance can be given that any of the Company's
development programs will be successfully completed, that any investigational
new drug ("IND") applications will become effective or that additional
clinical trials will be allowed by the Food and Drug Administration ("FDA")
or other regulatory authorities or that clinical trials will commence as
planned. As a result of FDA reviews or complications that may arise in any
phase of the clinical trial program, there can be no assurance that the
proposed schedules for IND and clinical protocol submissions to the FDA,
5.
<PAGE>
initiations of studies and completions of clinical trials can be maintained.
Any delays in the Company's clinical trials would have a material adverse
effect on the Company's business, financial condition and results of
operations.
DEPENDENCE ON COLLABORATIVE AND LICENSING ARRANGEMENTS
The Company's strategy for the research, development and
commercialization of its product candidates has required, and will continue
to require, the Company to enter into various arrangements with corporate and
academic collaborators, licensors, licensees and others, and the Company will
therefore be dependent upon the success of these parties in performing their
responsibilities. There can be no assurance that the Company will be able to
enter into additional collaborative arrangements or license agreements on
acceptable terms, or at all, or that any or all of the contemplated benefits
from such collaborative arrangements or license agreements will be realized.
Failure to obtain and maintain such arrangements or agreements would result
in delays in the development of the Company's proposed products, the
inability to proceed with the development, manufacture or sale of products,
or the loss of third party licenses or could require the Company to fund
development of a particular product candidate internally. If the Company were
required to fund development internally, its future capital requirements
would increase substantially. There can be no assurance that the Company
could obtain additional funds to meet such increased capital requirements on
acceptable terms, or at all.
Under the Company's collaborative arrangement with Biogen, Inc. and a
wholly-owned subsidiary of Biogen, Inc. (collectively, "Biogen"), Biogen is
responsible for pursuing all aspects of commercialization of CVT-124,
including but not limited to manufacturing clinical quantities of CVT-124,
conducting additional clinical trials, pursuing regulatory approvals,
scaling-up manufacturing processes and establishing marketing and sales
capabilities. The Company's relationship with Biogen may be terminated by
Biogen upon notice ranging from 60 to 90 days. Any such termination would
have a material adverse effect on the Company's business, financial condition
and results of operations. In addition, certain of the collaborative
arrangements that the Company may enter into in the future may place
responsibility on the collaborative partner for preclinical testing and
clinical trials, for manufacturing and for preparation and submission of
applications for regulatory approval of potential pharmaceutical products.
The Company cannot control the amount and timing of resources which its
collaborative partners devote to the Company's programs or potential
products. Should a collaborative partner fail to develop or commercialize
successfully any product candidate to which it has rights, the Company's
business financial condition and results of operations may be materially and
adversely affected. There can be no assurance that collaborators will not
pursue other technologies or product candidates either on their own or in
collaboration with others.
Collaborative arrangements may also require the Company to expend funds
and to meet certain milestones, and there can be no assurance that the
Company will be successful in doing so. The Company's agreement with the
University of Florida Research Foundation, Inc. in the area of adenosine
receptors requires the Company to reach certain preclinical and clinical
milestones within defined time periods to maintain exclusive rights under the
license. The Company's agreement with Syntex (U.S.A.), Inc. ("Syntex") for
ranolazine requires it to make a milestone payment to Syntex upon FDA
approval of an NDA for ranolazine. The Company's agreement with Biogen
requires the Company to meet certain development milestones in order to
receive or be entitled to retain certain payments. Failure of the Company to
meet its obligations under its collaborative arrangements could result in a
termination of those arrangements and the loss of rights to the compounds
under development and could have a material adverse effect on the Company's
business, financial condition and results of operations.
There can be no assurance that disputes will not arise in the future
with respect to the ownership of rights to any technology developed with or
by third parties. These and other possible disagreements between
collaborators and the Company could lead to delays in the collaborative
research, development or commercialization of certain product candidates or
could require or result in litigation or arbitration, which would be time
consuming and expensive, and would have a material adverse effect on the
Company's business, financial condition and results of operations.
6.
<PAGE>
HISTORY OF LOSSES AND EXPECTATION OF FUTURE LOSSES; UNCERTAINTY OF FUTURE
PROFITABILITY; ACCUMULATED DEFICIT
Since its inception, the Company has been engaged in research and
development activities and has generated no product revenues. As of September
30, 1997, the Company had an accumulated deficit of approximately $53.4
million. The process of developing the Company's products will require
significant additional research and development, preclinical testing and
clinical trials, as well as regulatory approvals. These activities, together
with the Company's general and administrative expenses, are expected to
result in operating losses for the foreseeable future. The Company will not
receive product revenues unless and until it or its collaborative partners
complete clinical trials and receive regulatory approval for commercial sale
with respect to one or more products and successfully commercialize such
products. There can be no assurance that the Company will generate revenues
or achieve and sustain profitability in the future.
NEED FOR ADDITIONAL FUTURE CAPITAL; UNCERTAINTY OF ADDITIONAL FUNDING
The Company will require substantial additional funding in order to
complete its research and development activities and commercialize any
potential products. The Company has financed its operations primarily through
the sale of equity securities, payments from its collaborators, equipment and
leasehold improvement financing and other debt financing. The Company has
generated no product revenue, and none is expected for at least several
years. The Company anticipates that its existing resources and projected
interest income will enable the Company to maintain its current and planned
operations through 1999. However, there can be no assurance that the Company
will not require additional funding prior to such time. The Company's future
capital requirements will depend on many factors, including scientific
progress in its research and development programs, the size and complexity of
such programs, the timing, scope and results of preclinical studies and
clinical trials conducted by the Company or its collaborators, the ability of
the Company to establish and maintain corporate partnerships, the time and
costs involved in obtaining regulatory approvals, the costs involved in
filing, prosecuting and enforcing patent claims, competing technological and
market developments, the cost of manufacturing or obtaining preclinical and
clinical material and other factors not within the Company's control. There
can be no assurance that such additional financing to meet the Company's
capital requirements will be available on acceptable terms or at all.
Insufficient funds may require the Company to delay, scale back or eliminate
some or all of its research or development programs or to lose rights under
existing licenses or to relinquish greater or all rights to product
candidates at an earlier stage of development or on less favorable terms than
the Company would otherwise seek or may adversely affect the Company's
ability to operate as a going concern. If additional funds are raised by
issuing equity securities, substantial dilution to existing stockholders may
result.
UNCERTAINTY OF MARKET ACCEPTANCE
The Company's future profitability is dependent on commercial acceptance
of its potential products. The Company believes that market acceptance of its
potential products will depend on the Company's or its collaborators' ability
to provide acceptable evidence of the safety, efficacy and cost effectiveness
of its products, as well as the effectiveness of its marketing strategy,
which may include its own marketing efforts as well as those of its
collaborators. In addition, third party payors can indirectly affect the
demand for the Company's potential products by regulating the maximum amount
of reimbursement that will be provided. There can be no assurance that
potential products developed by the Company or its collaborators will achieve
market acceptance among patients, physicians or third party payors, even if
necessary regulatory and reimbursement approvals are obtained. Failure to
achieve market acceptance would have a material adverse effect on the
Company's business, financial condition and results of operations.
INTENSE COMPETITION; RAPID TECHNOLOGICAL CHANGE
The pharmaceutical and biopharmaceutical industries are subject to
intense competition and significant, rapid technological change. If
regulatory approvals are received, certain of the Company's potential
products will
7.
<PAGE>
compete with well established, FDA approved proprietary and generic therapies
that have generated substantial sales over a number of years and which are
reimbursed from government health administration authorities and private
health insurers. In addition, CVT is aware of companies which are developing
products that will compete for the same disease markets as its potential
products. Many of the Company's competitors and potential competitors have
substantially greater product development capabilities and financial,
scientific, marketing and sales resources than the Company. Other companies
may succeed in developing products earlier than the Company, obtaining
approvals for such products from the FDA more rapidly than the Company and
its corporate partners, or developing products that are safer or more
effective than those under development or proposed to be developed by the
Company and its corporate partners. There can be no assurance that research
and development by others will not render the Company's technology or its
potential products obsolete or non-competitive. In addition, there can be no
assurance that the Company's competitors will not develop more effective or
more affordable products or achieve patent protection, regulatory approval or
product commercialization earlier than the Company.
UNCERTAINTY OF PATENT POSITION AND PROPRIETARY RIGHTS
The Company's success will depend to a significant degree on its ability
to obtain patents and licenses to patent rights, to maintain trade secrets
and to operate without infringing on the proprietary rights of others, both
in the United States and other countries. The Company holds three issued U.S.
patents and has filed a number of United States and foreign patent
applications covering certain of its compounds. In addition, in connection
with its corporate and academic collaborations, the Company has received
licenses to a number of issued patents and patent applications for ranolazine
and CVT 124. The Company intends to continue to file applications as
appropriate for patents covering both its potential products and processes.
There can be no assurance that patents will issue from any of these
applications, that any patent will issue on technology arising from
additional research or that patents that may issue from such applications
will be sufficient to protect the Company's technology. In particular, in
certain cases the Company is dependent upon third parties for the prosecution
of patents and patent applications. Failure of these third parties to
effectively prosecute such patents could have a material adverse effect on
the Company's ability to prevent competitors from developing similar
compounds. Patent applications in the United States are maintained in secrecy
until a patent issues, and the Company cannot be certain that others have not
filed patent applications for technology covered by the Company's pending
applications or that the Company was the first to invent the technology that
is the subject of such patent applications. Competitors may have filed
applications for, or may have received patents and may obtain additional
patents and proprietary rights relating to, compounds, products or processes
that block or compete with those of the Company. If any of its competitors
have filed patent applications in the United States that claim technology
also invented by the Company, the Company may have to participate in
interference proceedings declared by the Patent and Trademark Office in order
to determine priority of invention and, thus, the right to a patent for the
technology in the United States, all of which could result in substantial
cost to the Company. In addition, litigation, which would result in
substantial cost to the Company, may be necessary to enforce any patents
issued to the Company or to determine the scope and validity of the
proprietary rights of third parties. There can be no assurance that any
patents issued to the Company or to licensors from whom the Company has
licensed rights will not be challenged, invalidated or circumvented, or that
the rights granted thereunder will provide proprietary protection or
commercial advantage to the Company.
The commercial success of the Company will depend in part on the Company
not infringing patents issued to competitors and not breaching the licenses
that might cover technology used in the Company's potential products. Failure
by the Company to obtain a license to any technology required to
commercialize its potential products could have a material adverse effect on
the Company's business, financial condition and results of operations.
The Company also relies on trade secrets to develop and maintain its
competitive position. Although the Company protects its proprietary
technology in part by confidentiality agreements with its employees,
consultants, collaborators, advisors and corporate partners, there can be no
assurance that these agreements will not be breached, that the Company will
have adequate remedies for any breach or that the Company's trade secrets
will not otherwise become known or be discovered independently by its
competitors.
8.
<PAGE>
DEPENDENCE ON KEY PERSONNEL; NEED TO ATTRACT AND RETAIN KEY EMPLOYEES AND
CONSULTANTS
The Company is highly dependent on certain members of its management and
scientific staff. In addition, the Company relies on consultants and
advisors. The loss of any of these persons could have a material adverse
effect on the Company's business, financial condition and results of
operations. In order to pursue its research and product development plans,
the Company will be required to attract and retain additional qualified
scientific and other personnel. There can be no assurance that the Company
will be successful in attracting and retaining these skilled persons who
generally are in high demand by pharmaceutical and biopharmaceutical
companies and by universities and other research institutions. The failure to
successfully attract and retain qualified personnel, consultants and advisors
may impede the achievement of development objectives and have a material
adverse effect on the Company's business, financial condition and results of
operations. In addition, a substantial portion of the stock options currently
held by many of the Company's key employees are vested or may be fully vested
over the next several years before the Company achieves significant revenues
or profitability. The Company intends to grant additional options and
provide other forms of incentive compensation to attract and retain such key
personnel.
LIMITED MANUFACTURING, MARKETING AND SALES EXPERIENCE
The Company does not currently operate manufacturing facilities for
clinical or commercial production of its proposed products. The Company has
no experience in manufacturing, and currently lacks the resources or
capability to manufacture, any of its potential products on a clinical or
commercial scale. The Company is currently, and will continue to be,
dependent on corporate partners, licensees or other third parties for the
manufacturing of clinical and commercial scale quantities of its products.
For example, Biogen is responsible for the manufacture of CVT-124 to supply
clinical trials. In addition, the Company acquired from Syntex a sufficient
quantity of a sustained release formulation of ranolazine ("ranolazine SR")
tablets to supply the first Phase III trial. The Company has an agreement
with a third party manufacturer for clinical scale production of ranolazine's
active pharmaceutical ingredient sufficient to support the remainder of the
Phase III clinical program, registration and commercialization. The Company
is negotiating with third party manufacturers for clinical scale production
of ranolazine SR tablets sufficient to support the remainder of the Phase III
clinical program, registration and commercialization. There can be no
assurance that the Company will be able to maintain existing agreements for
manufacturing of clinical quantities of potential products, that it will be
able to establish or maintain agreements with other third parties or that
these parties will be able to develop adequate manufacturing capabilities. In
addition, prior to approval of an NDA for ranolazine, the Company will be
required to demonstrate to the FDA's satisfaction, the bioequivalence of the
multiple sources of ranolazine used in the Company's clinical trials.
The Company currently has no sales, marketing or distribution
capability. The Company may promote its products in collaboration with
marketing partners or rely on relationships with one or more companies with
established distribution systems and direct sales forces. In particular,
Biogen is responsible for establishing marketing and sales activities for
CVT-124. Alternatively, in the United States the Company may elect to
establish its own specialized sales force and marketing organization to
market its products to cardiologists. In the event that the Company is unable
to reach and maintain agreement with one or more pharmaceutical companies or
collaborative partners to market its products, it may be required to market
its products directly and to develop a marketing and sales force with
technical expertise and with supporting distribution capability. There can be
no assurance that the Company will be able to establish in-house sales and
distribution capabilities or relationships with third parties, or that it
will be successful in commercializing any of its potential products. To the
extent that the Company enters into co-promotion or other licensing
arrangements, any revenues received by the Company will depend upon the
efforts of third parties, and there can be no assurance that such efforts
will be successful.
SIGNIFICANT GOVERNMENT REGULATION; NO ASSURANCE OF REGULATORY APPROVAL
The research, testing, manufacture and marketing of drug products is
subject to extensive regulation by numerous regulatory authorities in the
United States and other countries. Failure to comply with FDA or other
9.
<PAGE>
applicable regulatory requirements may subject a company to administrative or
judicially imposed sanctions such as warning letters, civil penalties,
criminal prosecution, injunctions, product seizure or detention, product
recalls, total or partial suspension of production, and FDA refusal to
approve pending new drug applications ("NDAs") or supplements to approved
NDAs. The Company has not received regulatory approval in the United States
or any foreign jurisdiction for the commercial sale of any of its products.
The process of obtaining FDA and other required regulatory approvals,
including foreign approvals, often takes many years and can vary
substantially based upon the type, complexity and novelty of the products
involved. Furthermore, such approval process is extremely expensive and
uncertain. There can be no assurance that the Company's potential products
will be approved for marketing by the FDA. Even if regulatory approval of a
product is granted, there can be no assurance that the Company will be able
to obtain the labeling claims necessary or desirable for the promotion of
those products. FDA requirements prohibit the marketing or promotion of a
drug for unapproved indications. Furthermore, regulatory marketing approval
may entail ongoing requirements for postmarketing studies. If regulatory
approval is obtained, the Company will be subject to ongoing FDA obligations
and continued regulatory review. In particular, the Company or its third
party manufacturer will be required to adhere to regulations setting forth
current Good Manufacturing Practices, which require that the Company
manufacture its products and maintain its records in a prescribed manner with
respect to manufacturing, testing and quality control activities. Further,
the Company or its third party manufacturer must pass a preapproval
inspection of its manufacturing facilities by the FDA before obtaining
marketing approval. Failure to comply with applicable regulatory requirements
may result in penalties such as restrictions on a product's marketing or
withdrawal of the product from the market. In addition, identification of
certain side effects after a drug is on the market or the occurrence of
manufacturing problems could cause subsequent withdrawal of approval,
reformulation of the drug, additional preclinical testing or clinical trials
and changes in labeling of the product.
Prior to the submission of an NDA, drugs developed by the Company must
undergo rigorous preclinical and clinical testing, which may take several
years and the expenditure of substantial resources. Before commencing
clinical trials in humans, the Company must submit to the FDA and receive
clearance of an IND. There can be no assurance that submission of an IND for
future clinical testing of any products under development or other future
products of the Company would result in FDA permission to commence clinical
trials or that the Company will be able to obtain the necessary approvals for
future clinical testing in any foreign jurisdiction. Success in preclinical
studies or early stage clinical trials does not assure success in later stage
clinical trials. Data obtained from preclinical and clinical activities are
susceptible to varying interpretations which could delay, limit or prevent
regulatory approval. Further, there can be no assurance that if such testing
of products under development is completed, any such drug compounds will be
accepted for formal review by the FDA or any foreign regulatory body, or
approved by the FDA for marketing in the United States or by any such foreign
regulatory bodies for marketing in foreign jurisdictions. Future federal,
state, local or foreign legislation or administrative acts could also prevent
or delay regulatory approval of the Company's products.
On November 11, 1997, Congress passed the Food and Drug Administration
Modernization Act of 1997. This new legislation is intended to speed the
approval of new drugs and medical devices by streamlining FDA's review
procedures to ensure timely review of applications.
UNCERTAINTY OF PRODUCT PRICING AND REIMBURSEMENT
The ability of the Company and its existing and potential corporate
partners to market and sell its potential products successfully will depend
in part on the extent to which reimbursement for the cost of such potential
products and related treatments will be available from government health
administration authorities, private health insurers and other organizations.
Third party payors are increasingly challenging the price of medical products
and services. Significant uncertainty exists as to the reimbursement status
of newly approved health care products. In addition, for sales of the
Company's products in Europe, the Company will be required to seek
reimbursement on a country-by-country basis. If the Company or any existing
or potential corporate partners succeed in bringing any products to market,
there can be no assurance that these products will be considered cost
effective, that
10.
<PAGE>
reimbursement will be available, or if available, that the payors'
reimbursement policies will not adversely affect the Company's or any such
existing or potential corporate partner's ability to sell such products on a
profitable basis.
PRODUCT LIABILITY EXPOSURE; AVAILABILITY OF INSURANCE
The manufacture and sale of biopharmaceutical products involve an
inherent risk of product liability claims and associated adverse publicity.
The Company currently has only limited product liability insurance for
clinical trials and no commercial product liability insurance. There can be
no assurance that it will be able to maintain existing or obtain additional
product liability insurance on acceptable terms or with adequate coverage
against potential liabilities. Such insurance is expensive, difficult to
obtain and may not be available on acceptable terms, or at all. An inability
to obtain sufficient insurance coverage on reasonable terms or to otherwise
protect against potential product liability claims could prevent or inhibit
the commercialization of the Company's potential products. A successful
product liability claim brought against the Company in excess of its
insurance coverage, if any, could have a material adverse effect on the
Company's business, financial condition and results of operations.
HAZARDOUS AND RADIOACTIVE MATERIALS; ENVIRONMENTAL MATTERS
The Company's research and development processes involve the controlled
use of hazardous materials, chemicals and radioactive materials, and produce
waste products. The Company is subject to federal, state and local laws and
regulations governing the use, manufacture, storage, handling and disposal of
such materials and waste products. Although the Company believes that its
safety procedures for handling and disposing of such materials comply with
the standards prescribed by such laws and regulations, the risk of
contamination or injury from these materials cannot be eliminated completely.
In such event, the Company could be held liable for any damages that result
and any such liability could exceed the resources of the Company. Although
the Company believes that it is in compliance in all material respects with
applicable environmental laws and regulations, there can be no assurance that
it will not be required to incur significant costs to comply with
environmental laws and regulations in the future, or that the Company's
business, financial condition or results of operations will not be materially
adversely affected by current or future environmental laws or regulations.
VOLATILITY OF STOCK PRICE
The market price of the shares of Common Stock, like that of the common
stock of many other biopharmaceutical companies, is likely to continue to be
highly volatile. Factors such as the Company's operating results,
developments in the Company's relationships with corporate partners,
developments affecting the Company's corporate partners, results of
preclinical studies and clinical trials by the Company, its corporate
partners or its competitors, negative regulatory action or regulatory
approval with respect to the Company or its competitors, announcements of new
products by the Company or its competitors, developments related to patent or
other proprietary rights by the Company or its competitors, changes in the
position of securities analysts with respect to the Common Stock, and market
conditions for biopharmaceutical or biotechnology stocks in general, may
cause the market price of the Common Stock to fluctuate, perhaps
substantially. In addition, in recent years the stock market in general, and
the shares of biopharmaceutical, biotechnology and healthcare companies in
particular, have experienced extreme price fluctuations. These broad market
and industry fluctuations may materially adversely affect the market price of
the Common Stock. In some future quarter the Company's operating results may
be below the expectations of public market analysts and investors, and, as a
result, the price of the Common Stock would likely be materially adversely
affected.
CONTROL BY EXISTING STOCKHOLDERS; ANTI TAKEOVER EFFECTS OF CERTAIN CHARTER
PROVISIONS AND DELAWARE LAW
As of October 31, 1997, the Company's officers, directors and principal
stockholders beneficially owned approximately 41.93% of the outstanding
shares of the Common Stock. As a result, such persons may have the
11.
<PAGE>
ability to effectively control the Company and direct its affairs and
business. Such concentration of ownership may also have the effect of
delaying, deferring or preventing a change in control of the Company. In
addition, the Company's Board of Directors has the authority to issue up to
5,000,000 shares of Preferred Stock and to determine the price, rights,
preferences and privileges of those shares without any further vote or action
by the stockholders. The rights of the holders of Common Stock will be
subject to, and may be materially adversely affected by, the rights of the
holders of any Preferred Stock that may be issued in the future. The issuance
of Preferred Stock could have the effect of making it more difficult for a
third party to acquire a majority of the outstanding voting stock of the
Company. Furthermore, certain provisions of the Company's Amended and
Restated Certificate of Incorporation may have the effect of delaying or
preventing changes in control or management of the Company, which could
adversely affect the market price of the Company's Common Stock. In addition,
the Company is subject to the provisions of Section 203 of the Delaware
General Corporation Law, an anti-takeover law.
12.
<PAGE>
SELLING SECURITYHOLDERS
The following table sets forth the names of the Selling Securityholders,
the number of shares of Common Stock owned by the Selling Securityholders
prior to this offering, the number of shares of Common Stock being offered
for the account of the Selling Securityholders and the number of shares of
Common Stock to be owned by the Selling Securityholders after completion of
this offering. This information is based upon information provided by the
Selling Securityholders. Because the Selling Securityholders may offer all,
some or none of their Common Stock being offered, no definitive estimate as
to the number of Shares thereof that will be held by the Selling
Securityholders after such offering can be provided.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY
SHARES BENEFICIALLY SHARES BEING OWNED AFTER
SELLING SECURITYHOLDER OWNED PRIOR TO OFFERING(1) OFFERED OFFERING(1)(2)
- ---------------------- -------------------------- ------- --------------
NUMBER PERCENT NUMBER PERCENT
------ ------- ------ -------
<S> <C> <C> <C> <C> <C>
Syntex (U.S.A.), Inc. 75,000 * 75,000 -- --
Biotech Target S.A. 1,397,147 16.59% 1,397,147 -- --
</TABLE>
_______________
* Less than 1%
(1) Based on 8,420,074 shares outstanding as of October 31, 1997. The
Selling Securityholders named in the table have sole voting and
investment power with respect to all shares beneficially owned.
(2) Assumes the sale of all Shares offered hereby. See "Plan of
Distribution."
13.
<PAGE>
PLAN OF DISTRIBUTION
The Shares may be offered by the Selling Securityholders from time to
time in transactions on the Nasdaq National Market System, in privately
negotiated transactions or a combination of such methods of sale, at fixed
prices that may be changed, at market prices prevailing at the time of sale,
at prices related to such prevailing market prices or at negotiated prices.
The Selling Securityholders may effect such transactions by selling the
Shares directly or by or through agents or broker-dealers who may receive
compensation in the form of discounts, concessions or commissions from the
Selling Securityholders or the purchasers of the Shares for whom such
broker-dealers may act as agent or to whom they sell as principal or both
(which compensation to a particular broker-dealer might be in excess of
customary commissions).
The Selling Securityholders and any underwriters, dealers or agents that
participate in the distribution of the Shares may be deemed to be
"underwriters" within the meaning of the Securities Act, and any discounts,
commissions or concessions received by them and any provided pursuant to the
sale of the Shares by them might be deemed to be underwriting discounts and
commissions under the Securities Act. In order to comply with the
securities laws of certain states, if applicable, the Shares will be sold in
such jurisdictions only through registered or licensed brokers or dealers.
In addition, in certain states the Shares may not be sold unless the Shares
have been registered or qualified for sale in the applicable state or an
exemption from the registration or qualification requirement is available and
is complied with.
The Company is registering the Shares offered by the Selling
Securityholders hereunder pursuant to contractual registration rights
contained in the License Agreement and the Private Placement Agreement. The
Company will pay substantially all of the expenses incident to the offering
and sale of the Shares to the public, other than commissions, concessions and
discounts of underwriters, dealers or agents. Such expenses are estimated to
be $27,296. The Private Placement Agreement provides for
cross-indemnification of one of the Selling Securityholders and the Company
to the extent permitted by law, for losses, claims, damages, liabilities and
expenses arising, under certain circumstances, out of any registration of
1,397,147 of the Shares.
LEGAL MATTERS
The validity of the securities offered hereby will be passed upon for
the Company by Cooley Godward LLP ("Cooley"), Palo Alto, California. As of
the date of this Prospectus, Cooley owns a warrant to purchase 2,500 units at
a price of $.50 per unit with each unit consisting of one (1) share of Common
Stock and one warrant to purchase one-half (1/2) share of Common Stock at an
exercise price of $20.00 per share. GC&H Investments, a general partnership
formed by the partners of Cooley for investment purposes, owns 10,675 shares
of the Company's Common Stock and a warrant to purchase 875 shares of the
Company's Common Stock at an exercise price of $20.00 per share. Alan C.
Mendelson and Deborah A. Marshall, partners at Cooley, are the Secretary and
Assistant Secretary of the Company, respectively.
EXPERTS
The consolidated financial statements of CV Therapeutics, Inc. appearing
in the CV Therapeutics, Inc. Annual Report on Form 10-K for the year ended
December 31, 1996, have been audited by Ernst & Young LLP, independent
auditors, as set forth in their report thereon and incorporated by reference.
Such consolidated financial statements are incorporated herein by reference
in reliance upon such report given upon the authority of such firm as experts
in accounting and auditing.
14.
<PAGE>
- ------------------------------------------------------------------------------
- ------------------------------------------------------------------------------
NO DEALER, SALESPERSON OR OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS
AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED
UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY. THIS PROSPECTUS DOES NOT
CONSTITUTE AN OFFER OF ANY SECURITIES OTHER THAN THOSE TO WHICH IT RELATES OR
AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, TO ANY PERSON IN ANY
JURISDICTION WHERE SUCH OFFER OR SOLICITATION WOULD BE UNLAWFUL. NEITHER THE
DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL, UNDER ANY
CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THE INFORMATION CONTAINED HEREIN
IS CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE HEREOF.
-------------
TABLE OF CONTENTS
Page
----
Available Information ................................................. 2
Incorporation of Certain Documents by Reference ....................... 2
The Company ........................................................... 4
The Offering .......................................................... 4
Use of Proceeds ....................................................... 4
Dividend Policy ....................................................... 4
Risk Factors .......................................................... 5
Selling Securityholders ............................................... 12
Plan of Distribution ................................................. 13
Legal Matters ......................................................... 13
Experts ............................................................... 13
1,472,147 SHARES
CV THERAPEUTICS, INC.
COMMON STOCK
----------
PROSPECTUS
----------
DECEMBER 9, 1997
- ------------------------------------------------------------------------------
- ------------------------------------------------------------------------------
