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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON OCTOBER 24, 2000
REGISTRATION NO. 333-87339
===============================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________
POST-EFFECTIVE
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
_______________
CORVAS INTERNATIONAL, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 2834 33-0238812
(State or other (Primary Standard (I.R.S. Employer
jurisdiction of Industrial Identification Number)
incorporation or Classification
organization) Code Number)
3030 SCIENCE PARK ROAD
SAN DIEGO, CA 92121
(858) 455-9800
(Address, including zip code and telephone number, including area code, of
Registrant's principal executive offices)
_______________
RANDALL E. WOODS
PRESIDENT AND CHIEF EXECUTIVE OFFICER
CORVAS INTERNATIONAL, INC.
3030 SCIENCE PARK ROAD
SAN DIEGO, CA 92121
(858) 455-9800
(Name, address, including zip code and telephone number, including area code,
of agent for service)
_______________
COPIES TO:
BARBARA L. BORDEN, ESQ.
DENISE L. WOOLARD, ESQ.
COOLEY GODWARD LLP
4365 EXECUTIVE DRIVE, SUITE 1100
SAN DIEGO, CA 92121
_______________
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
From time to time after the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the
following box. [ ]
If any of the securities being registered on this Form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities
Act of 1933, other than securities offered only in connection with dividend
or interest reinvestment plans, check the following box. [x]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
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PROSPECTUS
4,224,000 SHARES
CORVAS INTERNATIONAL, INC.
COMMON STOCK
The selling stockholders are offering and selling up to 4,224,000 shares
of Corvas common stock under this prospectus. We will not receive any of the
proceeds from the sale of the shares by the selling stockholders.
The selling stockholders may offer their Corvas common stock through
public or private transactions, on or off the Nasdaq National Market, at
prevailing market prices, or at privately negotiated prices.
Our common stock is listed on the Nasdaq National Market under the
ticker symbol "CVAS." On October 23, 2000, the closing price of one share of
Corvas common stock on the Nasdaq National Market was $20.875.
________________
THE SHARES OF OUR COMMON STOCK OFFERED OR SOLD UNDER THIS PROSPECTUS
INVOLVE A HIGH DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 3.
________________
THE CORVAS SHARES OFFERED OR SOLD UNDER THIS PROSPECTUS HAVE NOT BEEN
APPROVED BY THE SEC OR ANY STATE SECURITIES COMMISSION, NOR HAVE THESE
ORGANIZATIONS DETERMINED THAT THIS PROSPECTUS IS ACCURATE OR COMPLETE. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
PROSPECTUS DATED OCTOBER 24, 2000
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THIS PROSPECTUS IS PART OF A REGISTRATION STATEMENT THAT WE FILED WITH
THE SEC. THE REGISTRATION STATEMENT INCLUDES EXHIBITS AND ADDITIONAL
INFORMATION NOT INCLUDED IN THIS PROSPECTUS.
WE HAVE NOT AUTHORIZED ANY PERSON TO GIVE YOU ANY SUPPLEMENTAL
INFORMATION OR MAKE ANY REPRESENTATIONS FOR US. YOU SHOULD ONLY RELY ON
INFORMATION ABOUT CORVAS THAT IS CONTAINED IN THIS PROSPECTUS OR IN ONE OF
OUR PUBLIC REPORTS FILED WITH THE SEC AND INCORPORATED INTO THIS PROSPECTUS.
INFORMATION CONTAINED IN THIS PROSPECTUS OR IN CORVAS' PUBLIC REPORTS MAY
BECOME OUTDATED. YOU SHOULD NOT ASSUME THAT THE INFORMATION IN THIS
PROSPECTUS IS ACCURATE OR COMPLETE AS OF ANY DATE OTHER THAN THE DATE ON THE
FRONT OF THIS PROSPECTUS OR OTHER DATE TO WHICH SPECIFIC INFORMATION
CONTAINED HEREIN IS QUALIFIED. WE ARE NOT MAKING AN OFFER OF SECURITIES IN
ANY STATE WHERE THE OFFER IS PROHIBITED.
THE COMPANY
We are a biopharmaceutical company engaged in the discovery, development
and commercialization of novel therapeutics that address large markets,
including cardiovascular disease, stroke and cancer. We currently have two
product candidates in Phase II clinical trials. Our lead product candidate is
UK-279,276, formerly rNIF, a recombinant protein in Phase II clinical trials
for the treatment of reperfusion injury associated with ischemic stroke.
Pfizer Inc., our collaborator for UK-279,276, has completed a Phase IIa
clinical trial in stroke patients and expects to initiate a Phase IIb
clinical trial in the fourth quarter of 2000. Our second product candidate,
known as rNAPc2, is a recombinant protein that we are developing for the
prevention of deep vein thrombosis and pulmonary embolism, and for the
treatment of unstable angina. We recently completed a successful Phase II
clinical trial for the prevention of deep vein thrombosis and pulmonary
embolism and, subject to government regulations, plan to initiate a Phase III
clinical trial for this indication in the second half of 2001. We also have a
number of research programs aimed at developing novel drugs to modulate
proteases involved in cancer and other diseases.
We originally incorporated in California in 1987 and reincorporated
in Delaware in 1993. Our executive offices are located at 3030 Science Park
Road, San Diego, California 92121, and our telephone number is (858)
455-9800. CORVAS-Registered Trademark- is a registered trademark and the
Corvas logo is our trademark. All other trademarks, trade names and product
names referred to in this prospectus are the property of their respective
owners.
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RISK FACTORS
YOU SHOULD CAREFULLY CONSIDER THE FOLLOWING RISK FACTORS AND OTHER
INFORMATION INCLUDED OR INCORPORATED BY REFERENCE IN THIS PROSPECTUS BEFORE
DECIDING TO INVEST IN THE SHARES.
WE HAVE A HISTORY OF OPERATING LOSSES AND WE MAY NEVER BECOME PROFITABLE.
We have experienced significant operating losses since our inception in
1987. At June 30, 2000, we had an accumulated deficit of approximately $95.3
million. We have not earned any revenues from commercial sales of any
therapeutic products. We have funded our operations principally from research
funding, license fees, milestone payments and sales of our equity and debt
securities. We expect to continue to incur substantial additional operating
losses for the next several years as we pursue our clinical trials and
research and development efforts. To become profitable, we, either alone or
with our collaborators, must successfully develop, manufacture and market our
current product candidates, particularly UK-279,276 and rNAPc2, as well as
continue to identify, develop, manufacture and market new product candidates.
It is possible that we will never have significant product sales revenue or
receive significant royalties on our licensed product candidates.
WE ARE AT AN EARLY STAGE OF DEVELOPMENT AND WE DO NOT HAVE, AND MAY NEVER
DEVELOP, ANY COMMERCIAL DRUGS OR OTHER PRODUCTS THAT GENERATE REVENUES.
We are at an early stage of development as a biopharmaceutical company,
and we do not have any commercial products. Our existing product candidates
will require significant additional development, clinical trials, regulatory
clearances and additional investment before they can be commercialized. Our
product development efforts may not lead to commercial drugs, either because
the product candidates fail to be safe and effective in clinical trials or
because we have inadequate financial or other resources to pursue the program
through the clinical trial process. We do not expect to be able to market any
of our existing product candidates for a number of years, if at all. If we
are unable to develop any commercial drugs, or if such development is
delayed, we will be unable to generate revenues, which may require that we
raise additional capital through financings or cease our operations.
WE ARE DEPENDENT ON THE SUCCESSFUL OUTCOME OF THE CLINICAL TRIALS FOR OUR TWO
MOST ADVANCED PRODUCT CANDIDATES, UK-279,276 AND rNAPc2.
UK-279,276 and rNAPc2 are our lead product candidates. Our success will
depend, to a great degree, on the success of these product candidates.
Pfizer, our collaborator on UK-279,276, has completed a Phase IIa clinical
trial for safety and dosing of UK-279,276 and it expects to begin a Phase IIb
efficacy trial of UK-279,276 in the fourth quarter of 2000 for the prevention
of reperfusion injury associated with ischemic stroke. We have completed a
Phase II clinical trial of rNAPc2 for the prevention of deep vein thrombosis
and pulmonary embolism. We are also currently conducting a Phase IIa clinical
trial of rNAPc2 in patients undergoing elective angioplasty to establish
safety prior to conducting additional clinical trials in patients with
unstable angina. Subject to government regulations, we intend to enter into
Phase III clinical trials for rNAPc2 in the second half of 2001.
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Our business prospects will depend on our ability and the ability of our
collaborators to complete patient enrollment in clinical trials, the ability
to obtain satisfactory results, the ability to obtain required regulatory
approvals and the ability to successfully commercialize these products. Many
factors affect patient enrollment, including the size of the patient
population, the proximity of patients to clinical sites and the eligibility
criteria for the trial. Delays in patient enrollment in the trials may result
in increased costs, program delays, or both, which could slow down our
product development and approval process. If clinical trials for these
product candidates are not completed or conducted as planned, or if either or
both of these products do not prove to be safe and effective or receive
required regulatory approvals, the commercialization of our product
candidates would be delayed or prevented, our business would be materially
harmed and our stock price would decline.
THE FDA HAS NOT APPROVED ANY OF OUR PRODUCT CANDIDATES AND WE MAY NEVER BE
PERMITTED TO COMMERCIALIZE ANY PRODUCT WE DEVELOP.
Our product candidates are in the early stages of development and have
not received required regulatory clearance from the Federal Drug
Administration, or the FDA, or any other regulatory body to be commercially
marketed and sold. The regulatory clearance process typically takes many
years and is extremely expensive and regulatory clearance is never
guaranteed. If we fail to obtain regulatory clearance for our current or
future product candidates, we will be unable to market and sell any products
and therefore may never be profitable.
As part of the regulatory clearance process, we must conduct, at our own
expense or our collaborators' expense, preclinical research and clinical
trials for each product candidate to demonstrate safety and efficacy. The
number of preclinical studies and clinical trials that will be required
varies depending on the product, the disease or condition that the product is
in development for, and regulations applicable to any particular product.
The regulatory process typically also includes a review of the
manufacturing process to ensure compliance with applicable standards. The FDA
can delay, limit or not grant approval for many reasons, including:
- a product candidate may not be safe or effective
- FDA officials may interpret data from preclinical testing and
clinical trials in different ways than we interpret it
- the FDA might not approve our manufacturing processes or
facilities, or the processes or facilities of our collaborators
- the FDA may change its approval policies or adopt new
regulations
The FDA also may approve a product candidate for fewer indications than
requested or may condition approval on the performance of post-marketing
studies for a product candidate.
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Even if we receive FDA and other regulatory approvals, our product
candidates may later exhibit adverse effects that limit or prevent their
widespread use or that force us to withdraw those product candidates from the
market.
In addition, any marketed product and its manufacturer continue to be
subject to strict regulation after approval. Any unforeseen problems with an
approved product or any violation of regulations could result in restrictions
on the product, including its withdrawal from the market.
The process of obtaining approvals in foreign countries is subject to
delay and failure for the same reasons. Any delay in, or failure to receive
approval for, any of our products could materially harm our business,
financial condition and results of operations.
OUR PRECLINICAL AND CLINICAL TESTING RESULTS ARE UNCERTAIN. IF TRIAL RESULTS
ARE NEGATIVE, WE MAY BE FORCED TO STOP DEVELOPING PRODUCT CANDIDATES
IMPORTANT TO OUR FUTURE.
The results of preclinical studies and initial clinical trials of our
product candidates do not necessarily predict the results from later-stage
clinical trials. Product candidates in later stages of clinical trials may
fail to show the desired safety and efficacy traits despite having progressed
through initial clinical testing. We cannot assure you that the data
collected from clinical trials of our product candidates will be sufficient
to support FDA or other regulatory approval.
Administering any product candidates we develop to humans may produce
undesirable side effects. These side effects could interrupt, delay or halt
clinical trials of our product candidates and could result in the FDA or
other regulatory authorities denying approval of our product candidates for
any or all targeted indications. The FDA, other regulatory authorities or we
may suspend or terminate clinical trials at any time. We cannot assure you
that any of our product candidates will be safe for human use.
IF WE FAIL TO OBTAIN ADDITIONAL FINANCING, WE MAY BE UNABLE TO COMPLETE THE
DEVELOPMENT AND COMMERCIALIZATION OF rNAPc2 AND OTHER PRODUCT CANDIDATES OR
CONTINUE OUR RESEARCH AND DEVELOPMENT PROGRAMS.
Our operations have consumed substantial amounts of cash since
inception. Our sources of revenue are primarily limited to research funding,
license fees and milestone payments from our corporate collaborators. During
1999, we had a net loss of approximately $13.0 million. We expect that we
will continue to spend substantial amounts on research and development,
including amounts spent for manufacturing clinical supplies, conducting
clinical trials for our product candidates and expanding our drug development
programs. We expect that the net proceeds from this offering, together with
our existing assets, will be sufficient to fund our operations for at least
the next two years. However, our future capital needs will depend on many
factors, including the receipt of milestone payments from our collaboration
with Pfizer, and progress in our research and development activities.
We do not have committed external sources of funding. If we are unable
to raise additional capital when required or on acceptable terms, we may have
to significantly delay, scale back or discontinue one or more of our drug
discovery programs, clinical trials or other aspects of our operations. We
also could be required to:
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- seek corporate collaborators for programs at an earlier stage
than would be desirable to maximize the rights to future product
candidates that we retain
- relinquish or license rights to technologies, product
candidates or products that we would otherwise seek to develop
or commercialize ourselves on terms that are less favorable to
us than might otherwise be available
IF WE FAIL TO MAINTAIN OUR EXISTING COLLABORATIVE RELATIONSHIPS, OR IF OUR
COLLABORATORS DO NOT DEVOTE ADEQUATE RESOURCES TO THE DEVELOPMENT AND
COMMERCIALIZATION OF OUR LICENSED PRODUCT CANDIDATES, WE MAY NOT BE ABLE TO
ACHIEVE PROFITABILITY.
We have granted exclusive development, commercialization and marketing
rights to Pfizer for the development of UK-279,276 and to Schering-Plough for
orally administered inhibitors of thrombosis and inhibitors of a key protease
associated with hepatitis C virus replication that have resulted from these
collaborations. These collaborators are responsible for all aspects of these
programs, including the conduct of research and development, clinical trials
and the regulatory approval process. We have no control over the amount and
timing of resources that our collaborators dedicate to the development of our
licensed product candidates. Our ability to generate royalties from our
collaborators depends on our collaborators' abilities to establish the safety
and efficacy of our product candidates, obtain regulatory approvals and
achieve market acceptance of our products. Our collaboration with
Schering-Plough relating to orally administered inhibitors of thrombosis is
scheduled to terminate in December 2000. If Pfizer or Schering-Plough do not
perform under our collaborative agreements, our potential for revenue from
the related product candidates will be dramatically reduced. Pfizer and
Schering-Plough may terminate our collaborative agreements on short notice.
Collaborative agreements generally pose the following risks:
- collaborators may not pursue further development and
commercialization of compounds resulting from collaborations
or may elect not to renew research and development programs
- collaborators may delay clinical trials, underfund a clinical
trial program, stop a clinical trial or abandon a product
candidate, repeat or conduct new clinical trials or require a
new formulation of a product candidate for clinical testing
- collaborators could independently develop, or develop with
third parties, products that could compete with our future
products
- the terms of our contracts with our current or future
collaborators may not be favorable to us in the future
- a collaborator with marketing and distribution rights to one
or more products may not commit enough resources to the
marketing and distribution of our products, limiting our
potential revenues from the commercialization of a product
6.
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- disputes may arise delaying or terminating the research,
development or commercialization of our product candidates,
or result in significant litigation or arbitration
- collaborations may be terminated and we will experience
increased capital requirements if we elect to pursue further
development of the product candidate
In addition, there have been a significant number of recent business
combinations among large pharmaceutical companies that have resulted in a
reduced number of potential future collaborators. If business combinations
involving our collaborators were to occur, the effect could be to diminish,
terminate or cause delays in one or more of our product development programs.
IF WE DO NOT FIND ADDITIONAL COLLABORATORS FOR OUR PRODUCT CANDIDATES, WE MAY
HAVE TO REDUCE OR DELAY OUR RATE OF PRODUCT DEVELOPMENT AND/OR INCREASE OUR
EXPENDITURES.
Our strategy for developing, manufacturing and commercializing our
products includes entering into various relationships with pharmaceutical
companies to advance our programs and reduce our expenditures on each
program. We may not be able to negotiate additional collaborations on
acceptable terms or at all. If we are not able to establish additional
collaborative arrangements, we may have to reduce or delay further
development of some of our programs and/or increase our expenditures and
undertake the development activities at our own expense. If we elect to
increase our capital expenditures to fund our development programs, we will
need to obtain additional capital, which may not be available on acceptable
terms or at all.
OUR COMPETITORS MAY DEVELOP AND MARKET DRUGS THAT ARE LESS EXPENSIVE, MORE
EFFECTIVE, OR SAFER WHICH MAY DIMINISH OR ELIMINATE THE COMMERCIAL SUCCESS OF
ANY PRODUCTS WE MAY COMMERCIALIZE.
The biopharmaceutical market is highly competitive. Almost all of the
larger biopharmaceutical companies have developed, or are attempting to
develop, products that will compete with products we may develop, including
some that are in late stage clinical trials. It is possible that our
competitors will develop and market products that are less expensive and more
effective than our future products or that will render our products obsolete.
It is also possible that our competitors will commercialize competing
products before any of our products are marketed. We expect that the
competition from other biopharmaceutical companies, pharmaceutical companies,
universities and public and private research institutions will increase. Many
of these competitors have substantially greater financial, technical,
research and other resources than we do. We may not have the financial
resources, technical expertise or marketing, distribution or support
capabilities to compete successfully.
FAILURE TO RETAIN OUR PRESIDENT AND CHIEF EXECUTIVE OFFICER, OUR EXECUTIVE
VICE PRESIDENT, RESEARCH AND DEVELOPMENT AND OTHER KEY PERSONNEL COULD
DECREASE OUR ABILITY TO OBTAIN FINANCING, CONDUCT CLINICAL TRIALS OR DEVELOP
OUR PRODUCT CANDIDATES.
We depend on our President and Chief Executive Officer, Randall E.
Woods, and our Executive Vice President, Research and Development, George P.
Vlasuk, Ph.D. The loss of either of these individuals may prevent us from
achieving our business objective of
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commercializing our product candidates. Both of these employees have
employment agreements with us, but the agreements provide for "at-will"
employment with no specified term. Our future success will also depend in
large part on our continued ability to attract and retain other highly
qualified scientific, technical and management personnel, as well as
personnel with expertise in clinical testing and governmental regulation. We
face competition for personnel from other companies, universities, public and
private research institutions, government entities and other organizations.
If we are unsuccessful in our recruitment and retention efforts, our business
operations will be harmed.
BECAUSE WE HAVE LIMITED MANUFACTURING EXPERIENCE AND WE RELY ON THIRD-PARTY
MANUFACTURERS, WE ARE UNABLE TO CONTROL THE AVAILABILITY OF OUR PRODUCT
CANDIDATES.
In order to be successful, our product candidates must be capable of
being manufactured in sufficient quantities, in compliance with regulatory
requirements, and at an acceptable cost. We have only limited experience in
pilot scale manufacturing. For larger-scale production, which is required for
clinical testing, we intend to rely on third parties to manufacture our
product candidates. If we cannot continue to contract for large-scale
manufacturing capabilities on acceptable terms, or if we encounter delays or
difficulties with manufacturers, we may not be able to conduct clinical
trials as planned. This would delay or halt submission of our product
candidates for regulatory clearance, and may prevent us from selling our
products and achieving profitability.
Also, our third-party manufacturers may be unable to manufacture any
product candidate we develop in commercial quantities on a cost-effective
basis. Covance Inc. is our sole supplier of our rNAPc2 product candidate.
Covance has recently announced that it has engaged investment bankers to
explore the possible divestiture of its pharmaceutical packaging and
biomanufacturing business. If for any reason Covance delays the supply of our
rNAPc2 product candidate, we may have to delay our clinical trials.
We may need to expand our existing relationships or establish new
relationships with additional third-party manufacturers for our current and
future product candidates. We may be unable to establish or maintain
relationships with third-party manufacturers on acceptable terms, or at all.
Our dependence on third parties may reduce our profit margins and delay or
limit our ability to develop and commercialize our products on a timely and
competitive basis. Furthermore, third-party manufacturers may encounter
manufacturing or quality control problems in connection with the manufacture
of our product candidates and may be unable to obtain or maintain the
necessary governmental licenses and approvals to manufacture our product
candidates. Any such failure could delay or preclude receiving regulatory
approvals to sell our product candidates.
IF WE ARE UNABLE TO PROTECT OUR PROPRIETARY TECHNOLOGY, WE MAY NOT BE ABLE TO
COMPETE AS EFFECTIVELY.
Our success depends in part on our ability to obtain and enforce patent
protection for our products, both in the United States and other countries,
and operate without infringing the proprietary rights of third parties. The
scope and extent of patent protection for our product candidates is uncertain
and frequently involves complex legal and factual questions. We cannot
predict the breadth of claims that will be allowed and issued in patents
related to biotechnology
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or pharmaceutical applications. Once such patents have issued, we cannot
predict how the claims will be construed or enforced. In addition, statutory
differences between countries may limit the protection we can obtain on some
of our inventions outside of the United States. For example, methods of
treating humans are not patentable in many countries outside of the United
States. We rely on patent and other intellectual property protection to
prevent our competitors from developing, manufacturing and marketing products
based on our technology. Our patents may not be enforceable and they may not
afford us protection against competitors, especially since there is a lengthy
lead time between when a patent application is filed and when it is actually
issued. Because of this, we may infringe on intellectual property rights of
others without being aware of the infringement. If a patent holder believes
that one of our product candidates infringes on their patent, they may sue us
even if we have received patent protection for our technology. If another
party claims we are infringing their technology, we could face a number of
issues, including the following:
- defending a lawsuit, which is very expensive and time
consuming
- paying a large sum for damages if we are found to be
infringing
- being prohibited from selling or licensing our products or
product candidates until we obtain a license from the patent
holder, who may refuse to grant us a license or will only
agree to do so on unfavorable terms. Even if we are granted a
license, we may have to pay substantial royalties or grant
cross-licenses to our patents
- redesigning our drug so it does not infringe on the patent
holder's technology if we are unable to obtain a license.
This may not be possible and, even if possible, it would
require substantial additional capital and would delay
commercialization
The coverage claimed in a patent application can be significantly
narrowed before a patent is issued, either in the United States or abroad. We
do not know whether any of our pending or future patent applications will
result in the issuance of patents. To the extent patents have been issued or
will be issued, we do not know whether these patents will be subjected to
further proceedings limiting their scope, will provide significant
proprietary protection or competitive advantage, or will be circumvented or
invalidated. Furthermore, patents already issued to us, or patents that may
issue on our pending applications, may become subject to dispute, including
interference proceedings in the United States to determine priority of
invention or opposition proceedings in foreign countries contesting the
validity of issued patents.
We also rely on trade secrets and proprietary know-how to develop and
maintain our competitive position. While we believe that we have protected
our trade secrets, some of our current or former employees, consultants or
scientific advisors, or current or prospective corporate collaborators, may
unintentionally or willfully disclose our confidential information to
competitors or use our proprietary technology for their own benefit.
Furthermore, enforcing a claim alleging the infringement of our trade secrets
would be expensive and difficult to prove, making the outcome uncertain. Our
competitors may also independently develop equivalent knowledge, methods and
know-how or gain access to our proprietary information through some other
means.
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Since we collaborate with third parties on some of our technology, there
is also the risk that disputes may arise as to the rights to technology or
drugs developed in collaboration with other parties.
IF WE BECOME SUBJECT TO PRODUCT LIABILITY CLAIMS, THE DAMAGES MAY EXCEED OUR
INSURANCE.
Since we conduct clinical trials on humans, we face the risk that the
use of our product candidates will result in adverse effects. These risks
will exist even for products that may be cleared for commercial sale. We have
obtained liability insurance of $10.0 million for our product candidates in
clinical trials. We cannot predict all of the possible harms or side effects
that may result and, therefore, the amount of insurance coverage we currently
hold may not be adequate to protect us from any liabilities. We may not have
sufficient resources to pay for any liabilities resulting from a claim beyond
the limit of our insurance coverage.
THE REIMBURSEMENT STATUS OF NEWLY APPROVED HEALTHCARE DRUGS IS UNCERTAIN AND
FAILURE TO OBTAIN ADEQUATE REIMBURSEMENT COULD LIMIT OUR ABILITY TO MARKET
ANY PRODUCTS WE MAY DEVELOP AND DECREASE OUR ABILITY TO GENERATE REVENUE.
There is significant uncertainty related to the reimbursement of newly
approved pharmaceutical products. Our and our collaborators' ability to
commercialize our products in both domestic and foreign markets will depend
in part on the reimbursements obtained from third-party payors such as
government health administration authorities, private health insurers,
managed care programs and other organizations. Third-party payors are
increasingly attempting to contain healthcare costs by limiting both coverage
and the level of reimbursement of new pharmaceutical products. Cost control
initiatives could decrease the price that we, or our collaborators, would
receive for our products and affect our ability to commercialize any products
we may develop. If third parties fail to provide reimbursement for any drugs
we may develop, consumers and doctors may not choose to use our products, and
we may not realize an acceptable return on our investment in product
development.
IF WE ARE UNABLE TO CREATE SALES, MARKETING AND DISTRIBUTION CAPABILITIES OR
ENTER INTO AGREEMENTS WITH THIRD PARTIES TO PERFORM THESE FUNCTIONS, WE WILL
NOT BE ABLE TO COMMERCIALIZE OUR PRODUCTS.
Because we do not have any marketed products, we have limited experience
in sales, marketing and distribution. To directly market and distribute any
products we may develop, we must build a substantial marketing and sales
force with appropriate technical expertise and supporting distribution
capabilities. Alternatively, we may obtain the assistance of a pharmaceutical
company or other entity with a large distribution system and a large direct
sales force. We may not be able to establish sales, marketing and
distribution capabilities of our own or enter into such arrangements with
third parties in a timely manner or on acceptable terms. To the extent that
we enter into co-promotion or other licensing arrangements, our product
revenues are likely to be lower than if we directly marketed and sold our
products, and any revenues we receive will depend upon the efforts of third
parties, which efforts may not be successful.
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THE GOVERNMENT HAS RIGHTS TO SOME OF OUR TECHNOLOGY.
In September 1999, we were awarded a government grant from the National
Institute for Allergy and Infectious Diseases to support our research related
to the treatment of malaria. As a result of the grant, the government has
rights in the technology, including inventions, developed with their funding.
In addition, the government may require us to grant to a third party an
exclusive license to any inventions resulting from the grant if the
government determines that we have not taken adequate steps to commercialize
inventions or for public health or safety needs.
OUR OPERATIONS INVOLVE HAZARDOUS MATERIALS AND WE MUST COMPLY WITH
ENVIRONMENTAL LAWS AND REGULATIONS, WHICH CAN BE EXPENSIVE.
Our research and development activities involve the controlled use of
hazardous materials, including chemicals and radioactive and biological
materials. Our operations also produce hazardous waste products. We are
subject to a variety of federal, state and local regulations relating to the
use, handling and disposal of these materials. We generally contract with
third parties for the disposal of such substances, and store our low level
radioactive waste at our facility until the materials are no longer
considered radioactive because there are no facilities permitted to accept
such waste in California or neighboring states. While we believe that we
comply with current regulatory requirements, we cannot eliminate the risk of
accidental contamination or injury from these materials. We may be required
to incur substantial costs to comply with current or future environmental and
safety regulations. If an accident or contamination occurred, we would likely
incur significant costs associated with civil penalties or criminal fines and
in complying with environmental laws and regulations.
OUR STOCK HAS BEEN, AND MAY CONTINUE TO BE, EXTREMELY VOLATILE AND YOUR
INVESTMENT IN OUR COMMON STOCK COULD DECLINE IN VALUE.
The market price of our common stock has been, and likely will continue
to be, extremely volatile. Our stock price could be subject to wide
fluctuations in response to a variety of factors, including the following:
- changes in the market valuations of biotechnology companies
- results of the government approval process for our products
and competing products
- announcements and results of our clinical trials and the
clinical trials of our competitors
- developments in our relationships with our existing or
future collaborators
- fluctuations in our operating results
- announcements of technological innovations or new products
or services by us or by our competitors
- developments related to patents or other proprietary rights
of us or others
11.
<PAGE>
- comments by securities analysts
- actions by governmental regulatory agencies
- announcements by us or our competitors of acquisitions,
strategic relationships, joint ventures or capital commitments
- developments in domestic and international governmental
policy or regulation
- additions or departures of our key personnel
- sales of our common stock in the open market
- other events or factors beyond our control
ANTI-TAKEOVER PROVISIONS IN OUR CERTIFICATE OF INCORPORATION, BYLAWS AND
STOCKHOLDER RIGHTS PLAN AND UNDER DELAWARE LAW MAY ADVERSELY AFFECT A
POTENTIAL TAKEOVER AND COULD PREVENT STOCKHOLDERS FROM RECEIVING A FAVORABLE
PRICE FOR THEIR SHARES.
Provisions in our certificate of incorporation and bylaws could
discourage potential acquisition proposals and could delay or prevent a
change in our control, even if the transaction would benefit our
stockholders. These provisions:
- authorize our board of directors, without requiring
stockholder approval, to issue up to 8.25 million shares of
"blank check" preferred stock to increase the number of
outstanding shares and prevent a takeover attempt
- limit who has the authority to call a special meeting of
stockholders
- prohibit stockholder action by written consent, thereby
requiring all stockholder actions to be taken at a meeting
of our stockholders
- require the approval of holders of at least 66 2/3% of our
voting stock as a condition to a merger or other specified
business transactions with, or proposed by, a holder of 15%
or more of our voting stock
Further, our board of directors has adopted a stockholder rights plan,
commonly known as a "poison pill," that may delay or prevent a change in
control.
ISSUANCE OF SHARES IN CONNECTION WITH FINANCING TRANSACTIONS OR UNDER STOCK
PLANS, OUTSTANDING WARRANTS AND OUTSTANDING CONVERTIBLE NOTES WILL DILUTE
CURRENT STOCKHOLDERS.
We maintain stock plans under which employees, directors and consultants
can acquire shares of our common stock through the exercise of stock options
and other purchase rights. We also have outstanding warrants and convertible
notes. You will incur dilution upon exercise of our outstanding options,
warrants and convertible notes. Both the number of certain outstanding
warrants and their exercise price are adjusted semi-annually due to the
accretion of interest on
12.
<PAGE>
our outstanding convertible notes. Therefore you will also incur dilution
when the number of warrants that are outstanding is adjusted.
If we raise additional funds by issuing additional stock, further
dilution to our stockholders will result, and new investors could have rights
superior to existing stockholders.
USE OF PROCEEDS
Corvas will not receive any proceeds from sales of Corvas shares by the
selling stockholders. The selling stockholders will receive the proceeds
from sales of these shares.
RECENT DEVELOPMENTS
In June 1996, as a recruiting incentive, we loaned our Chief Executive
Officer, Randall E. Woods, $200,000, interest-free, in connection with his
relocation to San Diego County, California. The note has been amended several
times by our board and Human Resources Committee. In July 1999, the note was
amended to increase the principal amount of the note to $277,500 and in
September 2000, the maturity date of the note was amended to be the earlier
of August 31, 2001 or within 90 days of Mr. Woods' termination of employment
with us. As of October 18, 2000, the outstanding principal on the loan was
$277,500.
13.
<PAGE>
SELLING STOCKHOLDERS
We are registering the 4,224,000 shares on behalf of the selling
stockholders pursuant to registration rights agreements we entered into with
the selling stockholders in connection with convertible debt and equity
financings closed concurrently on August 18, 1999. The term "selling
stockholders" includes the stockholders listed below and their transferees,
pledgees, donees or other successors.
Our registration of these Corvas shares does not necessarily mean that
the selling stockholders will sell any or all of these shares, or that
Artisan Equity Limited will elect to convert any of their convertible note
into common stock, or that it will elect to convert the convertible note for
the number of shares listed in the following table.
<TABLE>
<CAPTION>
NUMBER OF PERCENT OF NUMBER NUMBER OF PERCENT OF
SHARES SHARES OF SHARES SHARES
BENEFICIALLY BENEFICIALLY SHARES BENEFICIALLY BENEFICIALLY
OWNED PRIOR TO OWNED PRIOR TO BEING OWNED AFTER OWNED AFTER
NAME OF SELLING STOCKHOLDERS OFFERING(1) OFFERING(1)(2) OFFERED OFFERING(1)(3) OFFERING(1)(2)(3)
---------------------------- -------------- -------------- ----------- -------------- -----------------
<S> <C> <C> <C> <C> <C>
International Biotechnology 2,175,837 10.2% 300,000 1,875,837 8.8%
Trust, plc
Artisan Equity Limited(4) 4,483,707 17.4% 2,924,000 1,559,707 6.8%
Sofinov Societe Financiere 1,400,000 6.6% 1,000,000 400,000 1.9%
D'Innovation Inc. -------------- ----------- --------------
TOTAL 8,059,544 4,224,000 3,835,544
========= ========= =========
------------------------------------------------------------------------------------------------------------------------
</TABLE>
* Less than 1%
(1) This table is based on information contained in Schedules 13D
and 13G filed with the Securities and Exchange Commission.
Unless otherwise indicated below, the persons named in the table
have sole voting and investment power with respect to all shares
beneficially owned by them, subject to community property laws
where applicable.
(2) Applicable percentage of ownership is based on 21,309,505 shares
of common stock outstanding on October 18, 2000.
(3) Assumes the sale of all shares offered hereby.
(4) Assumes that both convertible notes accrete until the stated
maturity of August 17, 2006, and all principal and accretion are
converted into common stock immediately prior to maturity at
$3.25 per share.
14.
<PAGE>
PLAN OF DISTRIBUTION
The selling stockholders may offer their Corvas shares at various times
in one or more of the following transactions:
- on the Nasdaq National Market;
- in the over-the-counter market;
- in negotiated transactions other than the Nasdaq National Market
or the over-the-counter market;
- in connection with short sales of the Corvas shares;
- by pledge to secure debts and other obligations;
- in connection with the writing of call options, in hedge
transactions and in settlement of other transactions in
standardized or over-the-counter options; or
- in a combination of any of the above transactions.
The selling stockholders may sell their shares at market prices at the
time of sale, at prices related to such prevailing market prices, at
negotiated prices or at fixed prices. The selling stockholders may use
broker-dealers to sell their shares. If this happens, broker-dealers will
either receive discounts or commissions from the selling stockholders, or
they will receive commissions from purchasers for whom they acted as agents.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy the documents we file
at the SEC's public reference rooms in Washington, D.C., New York, New York
and Chicago, Illinois. Please call the SEC at 1-800-SEC-0330 for further
information on the public reference rooms. Our SEC filings are also
available to the public from the SEC's website at http://www.sec.gov.
The SEC allows us to "incorporate by reference" the information we file
with them, which means that we can disclose important information to you by
referring you to other documents. The information incorporated by reference
is considered to be 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
we will make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended:
1. Annual Report on Form 10-K for the fiscal year ended
December 31, 1999;
2. Quarterly Report on Form 10-Q for the quarter ended March 31,
2000; and
3. Quarterly Report on Form 10-Q for the quarter ended June 30,
2000.
You may request a free copy of these filings by writing to us at the
following address:
CORVAS INTERNATIONAL, INC.
ATTN: INVESTOR RELATIONS
3030 SCIENCE PARK ROAD
SAN DIEGO, CA 92121
15.
<PAGE>
LEGAL MATTERS
For purposes of this offering, Cooley Godward LLP, San Diego,
California, is giving its opinion on the validity of the shares.
EXPERTS
The Company's financial statements as of December 31, 1999 and 1998, and
for each of the years in the three-year period ended December 31, 1999 have
been incorporated by reference herein and in the registration statement, in
reliance upon the report of KPMG LLP, independent certified public
accountants, incorporated by reference herein, and upon the authority of said
firm as experts in accounting and auditing.
16.
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth all expenses payable by Corvas in
connection with the sale of the securities being registered. All the amounts
shown are estimates except for the SEC registration fee and the Nasdaq
National Market listing fee.
<TABLE>
<S> <C>
SEC Registration fee................................. $ 3,558.04
Nasdaq National Market listing fee................... 17,500.00
Legal fees and expenses.............................. 10,000.00
Accounting fees and expenses......................... 8,000.00
Miscellaneous........................................ 941.96
----------
Total....................................... $40,000.00
==========
</TABLE>
ITEM 15. INDEMNIFICATION OF OFFICERS AND DIRECTORS
Section 145 of the General Corporation Law of the State of Delaware (the
"Delaware Law") empowers a Delaware corporation to indemnify any persons who
are, or are threatened to be made, parties to any threatened, pending or
completed legal action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of
such corporation), by reason of the fact that such person was an officer or
director of such corporation, or is or was serving at the request of such
corporation as a director, officer, employee or agent of another corporation
or enterprise. The indemnity may include expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement of such action, suit
or proceeding, provided that such officer or director acted in good faith and
in a manner he or she reasonably believed to be in or not opposed to the
corporation's best interest, and, for criminal proceedings, had no reasonable
cause to believe his or her conduct was illegal. A Delaware corporation may
indemnify officers and directors against expenses (including attorneys' fees)
in connection with the defense or settlement of an action by or in the right
of the corporation under the same conditions, except that no indemnification
is permitted without judicial approval if the officer or director is adjudged
to be liable to the corporation. Where an officer or director is successful
on the merits or otherwise in the defense of any action referred to above,
the corporation must indemnify him or her against the expenses which such
officer or director actually and reasonably incurred.
II-1
<PAGE>
The Registrant's Bylaws contain a provision to limit the personal
liability of the directors of the Registrant for violations of their
fiduciary duty, except to the extent such limitation of liability is
prohibited by the Delaware Law. This provision eliminates each director's
liability to the Registrant or its stockholders for monetary damages except
(i) for any breach of the director's duty of loyalty to the Registrant 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 Law providing for liability of directors for unlawful payment
of dividends or unlawful stock purchases or redemptions, or (iv) for any
transaction from which a director derived an improper personal benefit. The
Registrant's Bylaws provide that the Registrant shall indemnify directors and
officers to the fullest extent permitted by law. The effect of these
provisions is to eliminate the personal liability of directors for monetary
damages for actions involving a breach of their fiduciary duty of care,
including any such actions involving gross negligence.
In addition, Registrant has entered into indemnity agreements with its
executive officers and directors whereby Registrant obligates itself to
indemnify such officers and directors from any amounts which the officer or
director becomes obligated to pay because of any claim made against him or
her arising out of any act or omission committed while he or she is acting in
his or her capacity as a director and/or officer of Registrant.
Registrant maintains directors and officers liability insurance coverage
that insures its officers and directors against certain losses that may arise
out of their positions with the Registrant and insures the Registrant for
liabilities it may incur to indemnify its officers and directors.
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
<S> <C>
4.3 * Common Stock Purchase Agreement between the Company and
International Biotechnology Trust plc ("IBT") and Societe
Financiere D'Innovation Inc. ("Sofinov"), dated as of
August 18, 1999.
4.4 * Registration Rights Agreement between the Company and IBT
and Sofinov, dated as of August 18, 1999.
4.5 * Note Purchase Agreement between the Company and Artisan
Equity Limited ("Artisan"), dated as of August 18, 1999.(1)
4.6 * 5.5% Convertible Senior Subordinated Note Due 2006, in the
principal amount of $6,500,000, issued to Artisan, dated
as of August 18, 1999.(1)
4.7 * Registration Rights Agreement between the Company and
Artisan, dated as of August 18, 1999.(1)
</TABLE>
II-2
<PAGE>
<TABLE>
<S> <C>
5.1 * Opinion of Cooley Godward LLP
23.1 Consent of KPMG LLP
23.2 Consent of Cooley Godward LLP. Reference is made to
Exhibit 5.1
24.1 * Power of Attorney. Reference is made to page II-5.
</TABLE>
------------------
* Previously filed.
(1) Incorporated by reference to Schedule 13D, filed by Artisan Equity
Limited on August 27, 1999.
ITEM 17. UNDERTAKINGS
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors and executive officers of the Registrant
pursuant to provisions described in Item 15 or otherwise, the Registrant has
been advised that in the opinion of the Commission such indemnification is
against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the Registrant of expenses incurred or
paid by a director or executive officer of the Registrant in the successful
defense of any action, suit or proceeding) is asserted by such director or
executive officer in connection with the securities being registered, the
Registrant will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Securities Act and will be governed by the
final adjudication of such issue.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration statement to
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement.
(2) That, for purposes of determining any liability under the
Securities Act, each filing of the Registrant's annual report pursuant to
Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each
filing of an employee benefit plan's annual report pursuant to Section 15(d)
of the Exchange Act) that is incorporated by reference in the registration
statement shall be deemed to be a new registration statement relating to the
securities offered therein and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.
(3) To deliver or cause to be delivered with the Prospectus, to each
person to whom the Prospectus is sent or given, the latest annual report to
security holders that is incorporated by reference in the Prospectus and
furnished pursuant to and meeting the requirements of Rule 14a-3 or Rule
14c-3 under the Exchange Act; and where interim financial information
required to be presented by Article 3 of Regulation S-X are not set forth in
the Prospectus, to deliver or cause to be delivered to each person to whom
the Prospectus is sent or given, the latest quarterly report
II-3
<PAGE>
that is specifically incorporated by reference in the Prospectus to provide
such interim financial information.
(4) That, for the purposes of determining liability under the
Securities Act, each post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
(5) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at the
termination of the offering.
(6) That, for purposes of determining any liability under the
Securities Act, the information omitted from the form of prospectus filed as
part of this Registration Statement in reliance upon Rule 430A and contained
in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act shall be deemed to be part of this
Registration Statement as of the time it was declared effective.
(7) For the purpose of determining any liability under the Securities
Act, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
II-4
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended,
the Registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this
Post-Effective Amendment No. 1 to the Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of San
Diego, State of California, on October 24, 2000.
CORVAS INTERNATIONAL, INC.
By: /s/ RANDALL E. WOODS
----------------------------------------
Randall E. Woods
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ RANDALL E. WOODS President, Chief Executive October 24, 2000
--------------------------- Officer and Director (PRINCIPAL
Randall E. Woods EXECUTIVE OFFICER)
/s/ CAROLYN M. FELZER Senior Director of Finance October 24, 2000
--------------------------- (PRINCIPAL FINANCIAL AND
Carolyn M. Felzer ACCOUNTING OFFICER)
/s/ M. BLAKE INGLE, PH.D. * Chairman of the Board of October 24, 2000
--------------------------- Directors
M. Blake Ingle, Ph.D.
Director October 24, 2000
---------------------------
Susan Bayh
Director October 24, 2000
---------------------------
J. Stuart Mackintosh
Director October 24, 2000
---------------------------
Burton E. Sobel, M.D.
/s/ MICHAEL SORELL, M.D. * Director October 24, 2000
---------------------------
Michael Sorrell, M.D.
</TABLE>
II-5
<PAGE>
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ NICOLE VITULLO * Director October 24, 2000
---------------------------
Nicole Vitullo
/s/ GEORGE P. VLASUK, PH.D. * Executive Vice President, October 24, 2000
--------------------------- Research and Development
George P. Vlasuk, Ph.D. and Director
</TABLE>
*By: /s/ CAROLYN M. FELZER
---------------------
Carolyn M. Felzer
Attorney-In-Fact
II-6
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
<S> <C>
4.3 * Common Stock Purchase Agreement between the Company and
International Biotechnology Trust plc ("IBT") and Societe
Financiere D'Innovation Inc. ("Sofinov"), dated as of
August 18, 1999.
4.4 * Registration Rights Agreement between the Company and IBT
and Sofinov, dated as of August 18, 1999.
4.5 * Note Purchase Agreement between the Company and Artisan
Equity Limited ("Artisan"), dated as of August 18, 1999.(1)
4.6 * 5.5% Convertible Senior Subordinated Note Due 2006, in the
principal amount of $6,500,000, issued to Artisan, dated
as of August 18, 1999.(1)
4.7 * Registration Rights Agreement between the Company and
Artisan, dated as of August 18, 1999.(1)
5.1 * Opinion of Cooley Godward LLP
23.1 Consent of KPMG LLP
23.2 Consent of Cooley Godward LLP. Reference is made to Exhibit 5.1
24.1 * Power of Attorney. Reference is made to page II-5.
</TABLE>
---------------------
* Previously filed.
(1) Incorporated by reference to Schedule 13D, filed by Artisan
Equity Limited on August 27, 1999.
