e424b2
Filed pursuant to Rule 424(b)(2)
Registration
Number 333-125786
Prospectus Supplement to Prospectus dated June 14, 2005.
5,000,000 Shares
Common Stock
Cytokinetics, Incorporated is selling 5,000,000 shares of
its common stock by this prospectus supplement at a price per
share of $6.60.
The common stock is quoted on the Nasdaq National Market under
the symbol CYTK. The last reported sale price of the
common stock on January 19, 2006 was $7.01 per share.
See Risk Factors on
page S-3 of this
prospectus supplement and on page of the accompanying prospectus
to read about factors you should consider before buying shares
of the common stock.
Neither the Securities and Exchange Commission nor any other
regulatory body has approved or disapproved of these securities
or passed upon the accuracy or adequacy of this prospectus
supplement or the accompanying prospectus. Any representation to
the contrary is a criminal offense.
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Per Share | |
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Total | |
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Price
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$ |
6.60 |
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$ |
33,000,000 |
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Advisors Fee
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$ |
0.20 |
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$ |
1,000,000 |
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Proceeds, before expenses, to
Cytokinetics
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$ |
6.40 |
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$ |
32,000,000 |
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We expect that delivery of the shares of common stock being
offered pursuant to this prospectus supplement will be made to
investors on or about January 23, 2006. Unless the
purchasers instruct otherwise, the shares of common stock will
be delivered in book-entry form through The Depository Trust
Company, New York, New York.
Prospectus Supplement dated January 20, 2006.
ABOUT THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of the common
stock being offered by us. The second part, the accompanying
prospectus dated June 14, 2005, gives more general
information about our common stock. You should read the entire
prospectus supplement and the accompanying prospectus, as well
as the information incorporated by reference in this prospectus
supplement and the accompanying prospectus, before making an
investment decision.
You should rely only on the information contained or
incorporated by reference in this prospectus supplement and the
accompanying prospectus. If the description of the offering
varies between this prospectus supplement and the accompanying
prospectus, you should rely on the information in this
prospectus supplement. We have not authorized anyone to provide
you with information different from that contained or
incorporated by reference in this prospectus supplement and the
accompanying prospectus. Under no circumstances should the
delivery to you of this prospectus supplement and the
accompanying prospectus or any sale made pursuant to this
prospectus supplement create any implication that the
information contained in this prospectus supplement and the
accompanying prospectus is correct as of any time after the date
of this prospectus supplement.
Unless we indicate otherwise, references in this prospectus
supplement to Cytokinetics, we,
our and us refer to Cytokinetics,
Incorporated.
S-1
The Offering
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Common Stock we are offering |
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5,000,000 shares |
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Common stock to be outstanding after this offering* |
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35,544,730 shares |
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Risk factors |
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See Risk Factors beginning on
page S-3 for a
discussion of factors that you should consider before buying
shares of our common stock. |
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Nasdaq National Market Symbol |
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CYTK |
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Use of Proceeds |
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We intend to use the net proceeds of this offering to fund
research and development, including clinical trials of our
product candidates, and for general corporate purposes. See
Use of Proceeds on
page S-22 of this
prospectus supplement. |
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* |
The information above regarding outstanding shares of common
stock is based on approximately 30,544,730 shares of common
stock outstanding as of January 17, 2006. As of
September 30, 2005, we had a total of
28,660,743 shares of common stock issued and outstanding. |
See Description of Common Stock on
page S-23 for
additional information on the number of shares of common stock
to be outstanding after this offering.
S-2
RISK FACTORS
Our business is subject to various risks, including those
described below. You should carefully consider the following
risks, together with all of the other information included in
this prospectus supplement, the accompanying prospectus and the
documents incorporated by reference before investing in our
common stock. Any of these risks could materially adversely
affect our business, operating results and financial
condition.
Risks Related To Our Business
Our drug candidates are in the early stages of clinical
testing and we have a history of significant losses and may not
achieve or sustain profitability and, as a result, you may lose
all or part of your investment.
Our drug candidates are in the early stages of clinical testing
and we must conduct significant additional clinical trials
before we can seek the regulatory approvals necessary to begin
commercial sales of our drugs. We have incurred operating losses
in each year since our inception in 1997 due to costs incurred
in connection with our research and development activities and
general and administrative costs associated with our operations.
We expect to incur increasing losses for at least several years,
as we continue our research activities and conduct development
of, and seek regulatory approvals for, our drug candidates, and
commercialize any approved drugs. If our drug candidates fail in
clinical trials or do not gain regulatory approval, or if our
drugs do not achieve market acceptance, we will not be
profitable. If we fail to become and remain profitable, or if we
are unable to fund our continuing losses, you could lose all or
part of your investment.
We have never generated, and may never generate, revenues
from commercial sales of our drugs and we may not have drugs to
market for at least several years, if ever.
We currently have no drugs for sale and we cannot guarantee that
we will ever have marketable drugs. We must demonstrate that our
drug candidates satisfy rigorous standards of safety and
efficacy to the U.S. Food and Drug Administration, or FDA,
and other regulatory authorities in the United States and
abroad. We and our partners will need to conduct significant
additional research and preclinical and clinical testing before
we or our partners can file applications with the FDA or other
regulatory authorities for approval of our drug candidates. In
addition, to compete effectively, our drugs must be easy to use,
cost-effective and economical to manufacture on a commercial
scale, compared to other therapies available for the treatment
of the same conditions. We may not achieve any of these
objectives. Ispinesib, our most advanced drug candidate for the
treatment of cancer,
SB-743921, our second
drug candidate for the treatment of cancer, and
CK-1827452 in an
intravenous form, our drug candidate for the treatment of heart
failure, are currently our only drug candidates in clinical
trials and we cannot be certain that the clinical development of
these or any other drug candidate in preclinical testing or
clinical development will be successful, that they will receive
the regulatory approvals required to commercialize them, or that
any of our other research programs will yield a drug candidate
suitable for entry into clinical trials. Our commercial
revenues, if any, will be derived from sales of drugs that we do
not expect to be commercially available for several years, if at
all. The development of any one or all of these drug candidates
may be discontinued at any stage of our clinical trials programs
and we may not generate revenue from any of these drug
candidates.
We have funded all of our operations and capital expenditures
with proceeds from both private and public sales of our equity
securities, strategic alliances with GlaxoSmithKline, or GSK,
AstraZeneca and others, equipment financings, interest on
investments and government grants. We believe that our existing
cash and cash equivalents, future payments from GSK and
AstraZeneca, interest earned on investments, proceeds from
equipment financings and potential proceeds from our committed
equity financing facility with Kingsbridge Capital Limited, or
Kingsbridge, will be sufficient
S-3
to meet our projected operating requirements for at least the
next 12 months. To meet our future cash requirements, we
may raise funds through public or private equity offerings, debt
financings or strategic alliances. To the extent that we raise
additional funds by issuing equity securities, our stockholders
may experience additional dilution. To the extent that we raise
additional funds through debt financing, if available, such
financing may involve covenants that restrict our business
activities. To the extent that we raise additional funds through
strategic alliance and licensing arrangements, we will likely
have to relinquish valuable rights to our technologies, research
programs or drug candidates, or grant licenses on terms that may
not be favorable to us. In addition, we cannot assure you that
any such funding, if needed, will be available on attractive
terms, or at all.
Clinical trials may fail to demonstrate the desired safety
and efficacy of our drug candidates, which could prevent or
significantly delay completion of clinical development and
regulatory approval.
Prior to receiving approval to commercialize any of our drug
candidates, we must demonstrate with substantial evidence from
well-controlled clinical trials, and to the satisfaction of the
FDA and other regulatory authorities in the United States and
abroad, that such drug candidate is both sufficiently safe and
effective. Before we can commence clinical trials, we must
demonstrate through preclinical studies satisfactory product
chemistry, formulation, stability and toxicity levels in order
to file an investigational new drug application, or IND, (or the
foreign equivalent of an IND) to commence clinical trials. In
clinical trials we will need to demonstrate efficacy for the
treatment of specific indications and monitor safety throughout
the clinical development process. Long-term safety and efficacy
have not yet been demonstrated in clinical trials for any of our
drug candidates, and satisfactory chemistry, formulation,
stability and toxicity levels have not yet been demonstrated for
any of our potential drug candidates or compounds that are
currently the subject of preclinical studies. If our preclinical
studies, current clinical trials or future clinical trials are
unsuccessful, our business and reputation will be harmed and our
stock price will be negatively affected.
All of our drug candidates are prone to the risks of failure
inherent in drug development. Preclinical studies may not yield
results that would satisfactorily support the filing of an IND
(or the foreign equivalent of an IND) with respect to our
potential drug candidates, and, even if these applications would
be or have been filed with respect to our drug candidates, the
results of preclinical studies do not necessarily predict the
results of clinical trials. Similarly, early-stage clinical
trials do not predict the results of later-stage clinical
trials, including the safety and efficacy profiles of any
particular drug candidate. In addition, there can be no
assurance that the design of our clinical trials is focused on
appropriate tumor types, patient populations, dosing regimens or
other variables which will result in obtaining the desired
efficacy data to support regulatory approval to commercialize
the drug. Even if we believe the data collected from clinical
trials of our drug candidates are promising, such data may not
be sufficient to support approval by the FDA or any other U.S.
or foreign regulatory authority. Preclinical and clinical data
can be interpreted in different ways. Accordingly, FDA officials
or officials from foreign regulatory authorities could interpret
the data in different ways than we or our partners do, which
could delay, limit or prevent regulatory approval.
Administering any of our drug candidates or potential drug
candidates that are the subject of preclinical studies to
animals may produce undesirable side effects, also known as
adverse effects. Toxicities and adverse effects that we have
observed in preclinical studies for some compounds in a
particular research and development program may occur in
preclinical studies or clinical trials of other compounds from
the same program. Such toxicities or adverse effects could delay
or prevent the filing of an IND (or the foreign equivalent of an
IND) with respect to such drug candidates or potential drug
candidates or cause us to cease clinical trials with respect to
any drug candidate. In Phase I clinical trials of
ispinesib, the dose limiting toxicity was neutropenia, a
decrease in the number of a certain type of white blood cell
that results in an increase in susceptibility to infection. In a
Phase I clinical trial of
SB-743921, the
dose-limiting toxicities observed to date were: prolonged
neutropenia, with or without fever and with or without
infection; elevated transaminases and
S-4
hyperbilirubenemia, both of which are abnormalities of liver
function; and hyponatremia, which is a low concentration of
sodium in the blood. In clinical trials, administering any of
our drug candidates to humans may produce adverse effects. These
adverse effects could interrupt, delay or halt clinical trials
of our drug candidates and could result in the FDA or other
regulatory authorities denying approval of our drug candidates
for any or all targeted indications. The FDA, other regulatory
authorities, our partners or we may suspend or terminate
clinical trials at any time. Even if one or more of our drug
candidates were approved for sale, the occurrence of even a
limited number of toxicities or adverse effects when used in
large populations may cause the FDA to impose restrictions on,
or stop, the further marketing of such drugs. Indications of
potential adverse effects or toxicities which may occur in
clinical trials and which we believe are not significant during
the course of such clinical trials may later turn out to
actually constitute serious adverse effects or toxicities when a
drug has been used in large populations or for extended periods
of time. Any failure or significant delay in completing
preclinical studies or clinical trials for our drug candidates,
or in receiving and maintaining regulatory approval for the sale
of any drugs resulting from our drug candidates, may severely
harm our reputation and business.
Clinical trials are expensive, time consuming and subject to
delay.
Clinical trials are very expensive and difficult to design and
implement, especially in the cancer and heart failure
indications that we are pursuing, in part because they are
subject to rigorous requirements. The clinical trial process is
also time consuming. According to industry studies, the entire
drug development and testing process takes on average 12 to
15 years, and the fully capitalized resource cost of new
drug development averages approximately $800 million.
However, individual clinical trials and individual drug
candidates may incur a range of costs or time demands above or
below this average. We estimate that clinical trials of our most
advanced drug candidates will continue for several years, but
they may take significantly longer to complete. The commence-
ment and completion of our clinical trials could be delayed or
prevented by several factors, including, but not limited to:
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delays in obtaining regulatory approvals to commence a clinical
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delays in identifying and reaching agreement on acceptable terms
with prospective clinical trial sites; |
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slower than expected rates of patient recruitment and
enrollment, including as a result of the introduction of
alternative therapies or drugs by others; |
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lack of effectiveness during clinical trials; |
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unforeseen safety issues; |
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adequate supply of clinical trial material; |
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uncertain dosing issues; |
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introduction of new therapies or changes in standards of
practice or regulatory guidance that render our clinical trial
endpoints or the targeting of our proposed indications obsolete; |
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inability to monitor patients adequately during or after
treatment; and |
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inability or unwillingness of medical investigators to follow
our clinical protocols. |
We do not know whether planned clinical trials will begin on
time, will need to be restructured or will be completed on
schedule, if at all. Significant delays in clinical trials will
impede our ability to commercialize our drug candidates and
generate revenue and could significantly increase our
development costs.
S-5
We depend on GSK for the conduct, completion and funding of
the clinical development and commercialization of our current
drug candidates for the treatment of cancer.
Under our strategic alliance with GSK, as amended, GSK is
currently responsible for the clinical development and
regulatory approval of our drug candidate ispinesib and our
potential drug candidate
GSK-923295 for all
cancer indications, and our drug candidate
SB-743921 for all
cancer indications except non-Hodgkins lymphoma,
Hodgkins lymphoma and multiple myeloma. Other than our
right to file INDs (or the foreign equivalent of INDs) for
SB-743921 for these
three hematologic cancer indications, GSK is responsible for
filing applications with the FDA or other regulatory authorities
for approval of these drug candidates and our potential drug
candidate and will be the owner of any marketing approvals
issued by the FDA or other regulatory authorities. If the FDA or
other regulatory authorities approve these drug candidates, GSK
will also be responsible for the marketing and sale of these
drugs. Because GSK is responsible for these functions, we cannot
control whether GSK will devote sufficient attention and
resources to the clinical trials program or will proceed in an
expeditious manner. GSK generally has discretion to elect
whether to pursue the development of our drug candidates or to
abandon the clinical trial programs, and, after June 20,
2006, GSK may terminate our strategic alliance for any reason
upon six months prior notice. These decisions are outside our
control. Two of our cancer drug candidates being developed by
GSK act through inhibition of kinesin spindle protein, or KSP, a
protein that is a member of a class of cytoskeletal proteins
called mitotic kinesins that regulate cell division, or mitosis,
during cell division. Because these drug candidates have similar
mechanisms of action, GSK may elect to proceed with the
development of only one such drug candidate. If GSK were to
elect to proceed with the development of
SB-743921 in lieu of
ispinesib, because SB-743921 is at an earlier stage of clinical
development than ispinesib, the approval, if any, of a new drug
application, or NDA, with respect to a drug candidate from our
cancer program would be delayed. In particular, if the initial
clinical results of some of our early clinical trials do not
meet GSKs expectations, GSK may elect to terminate further
development of one or both drug candidates or certain of the
ongoing clinical trials for drug candidates, even though the
actual number of patients that have been treated is relatively
small. The platinum refractory arm of our non-small cell lung
cancer Phase II clinical trial evaluating ispinesib as
monotherapy did not meet the clinical trials pre-defined
criteria for advancement and it is possible that the platinum
sensitive arm of such clinical trial, for which data are
expected in the first quarter of 2006, may also not meet such
clinical trials pre-defined criteria for advancement.
Furthermore, GSK may elect to terminate one or more clinical
trials for ispinesib at any time for some or all indications,
including indications which GSK previously determined to advance
to the next stage of patient enrollment, such as the ongoing
breast cancer clinical trial, even though such clinical trial
may not yet have been completed and regardless of clinical
activity that may have been demonstrated.
Abandonment of one or more of ispinesib,
SB-743921 and
GSK-923295 by GSK would
result in a delay in or prevent us from commercializing such
current or potential drug candidates, and would delay or prevent
our ability to generate revenues. Disputes may arise between us
and GSK, which may delay or cause termination of any clinical
trials program, result in significant litigation or arbitration,
or cause GSK to act in a manner that is not in our best
interest. If development of our current and potential drug
candidates does not progress for these or any other reasons, we
would not receive further milestone payments from GSK. GSK has
the right to reduce its funding of our full time equivalents, or
FTEs, for these programs at its discretion, subject to certain
agreed minimum levels, in the beginning of each contract year
based on the activities of the agreed upon research plan. In
addition, the five year research term of the strategic alliance
expires on June 20, 2006, unless GSK agrees to extend the
research term. Even if the FDA or other regulatory agencies
approve one or more of our drug candidates, GSK may elect not to
proceed with the commerciali-
zation of such drugs, or may elect to pursue commercialization
of one drug but not others, and these decisions are outside our
control. In such event, or if GSK abandons development of any
drug candidate prior to regulatory approval, we would have to
undertake and fund the clinical development of our drug
candidates or commercialization of our drugs, seek a new partner
for clinical development or commercialization, or curtail or
abandon the clinical development or
S-6
commercialization programs. If we were unable to do so on
acceptable terms, or at all, our business would be harmed, and
the price of our common stock would be negatively affected.
If we fail to enter into and maintain successful strategic
alliances for certain of our drug candidates, we may have to
reduce or delay our drug candidate development or increase our
expenditures.
Our strategy for developing, manufacturing and commercializing
certain of our drug candidates currently requires us to enter
into and successfully maintain strategic alliances with
pharmaceutical companies or other industry participants to
advance our programs and reduce our expenditures on each
program. We have formed a strategic alliance with GSK with
respect to ispinesib,
SB-743921,
GSK-923295 and certain
other research activities. However, we may not be able to
negotiate additional strategic alliances on acceptable terms, if
at all. If we are not able to maintain our existing strategic
alliances or establish and maintain additional strategic
alliances, we may have to limit the size or scope of, or delay,
one or more of our drug development programs or research
programs or undertake and fund these programs ourselves. If we
elect to increase our expenditures to fund drug development
programs or research programs on our own, we will need to obtain
additional capital, which may not be available on acceptable
terms, or at all.
The success of our development efforts depends in part on the
performance of our partners and the National Cancer Institute,
or NCI, over which we have little or no control.
Our ability to commercialize drugs that we develop with our
partners and that generate royalties from product sales depends
on our partners abilities to assist us in establishing the
safety and efficacy of our drug candidates, obtaining and
maintaining regulatory approvals and achieving market acceptance
of the drugs once commercialized. Our partners may elect to
delay or terminate development of one or more drug candidates,
independently develop drugs that could compete with ours or fail
to commit sufficient resources to the marketing and distribution
of drugs developed through their strategic alliances with us.
Our partners may not proceed with the development and
commercialization of our drug candidates with the same degree of
urgency as we would because of other priorities they face. In
particular, we are relying on the NCI to conduct several
important clinical trials of ispinesib. The NCI is a government
agency and there can be no assurance that the NCI will not
modify its plans to conduct such clinical trials or will proceed
with such clinical trials diligently. We have no control over
the conduct of clinical trials, the timing of initiation or
completion or the announcement of results of clinical trials
being conducted by the NCI. If our partners fail to perform as
we expect, our potential for revenue from drugs developed
through our strategic alliances, if any, could be dramatically
reduced.
Our focus on the discovery of drug candidates directed
against specific proteins and pathways within the cytoskeleton
is unproven, and we do not know whether we will be able to
develop any drug candidates of commercial value.
We believe that our focus on drug discovery and development
directed at the cytoskeleton is novel and unique. While a number
of commonly used drugs and a growing body of research validate
the importance of the cytoskeleton in the origin and progression
of a number of diseases, no existing drugs specifically and
directly interact with the cytoskeletal proteins and pathways
that our drug candidates seek to modulate. As a result, we
cannot be certain that our drug candidates will appropriately
modulate the targeted cytoskeletal proteins and pathways or
produce commercially viable drugs that safely and effectively
treat cancer, heart failure or other diseases, or that the
results we have seen in preclinical models will translate into
similar results in humans. In addition, even if we are
successful in developing and receiving regulatory approval for a
commercially viable drug for the treatment of one disease
focused on the cytoskeleton, we cannot be certain that we will
also be able to develop and receive regulatory approval for drug
candidates for the treatment of other forms
S-7
of that disease or other diseases. If we or our partners fail to
develop and commercialize viable drugs, we will not achieve
commercial success.
Our proprietary rights may not adequately protect our
technologies and drug candidates.
Our commercial success will depend in part on our obtaining and
maintaining patent protection and trade secret protection of our
technologies and drug candidates as well as successfully
defending these patents against third-party challenges. We will
only be able to protect our technologies and drug candidates
from unauthorized use by third parties to the extent that valid
and enforceable patents or trade secrets cover them. In the
event that our issued patents and our applications, if they are
granted, do not adequately describe, enable or otherwise provide
coverage of our technologies and drug candidates, including for
example ispinesib,
SB-743921,
GSK-923295 and
CK-1827452, we would
not be able to exclude others from developing or commercializing
these drug candidates and potential drug candidates.
Furthermore, the degree of future protection of our proprietary
rights is uncertain because legal means afford only limited
protection and may not adequately protect our rights or permit
us to gain or keep our competitive advantage.
The patent positions of life sciences companies can be highly
uncertain and involve complex legal and factual questions for
which important legal principles remain unresolved. No
consistent policy regarding the breadth of claims allowed in
such companies patents has emerged to date in the United
States The patent situation outside the United States is even
more uncertain. Changes in either the patent laws or in
interpretations of patent laws in the United States or other
countries may diminish the value of our intellectual property.
Accordingly, we cannot predict the breadth of claims that may be
allowed or enforced in our patents or in third-party patents.
For example:
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we or our licensors might not have been the first to make the
inventions covered by each of our pending patent applications
and issued patents; |
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we or our licensors might not have been the first to file patent
applications for these inventions; |
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others may independently develop similar or alternative
technologies or duplicate any of our technologies without
infringing our intellectual property rights; |
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one or more of our pending patent applications or the pending
patent applications of our licensors may not result in issued
patents; |
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our issued patents and issued patents of our licensors may not
provide a basis for commercially viable drugs, or may not
provide us with any competitive advantages, or may be challenged
and invalidated by third parties; |
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we may not develop additional proprietary technologies or drug
candidates that are patentable; and |
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the patents of others may prevent us or our partners from
developing or commercializing our drug candidates. |
We also rely on trade secrets to protect our technology,
especially where we believe patent protection is not appropriate
or obtainable. However, trade secrets are difficult to protect.
While we use reasonable efforts to protect our trade secrets,
our or our strategic partners employees, consultants,
contractors or scientific and other advisors may unintentionally
or willfully disclose our information to competitors. In
addition, confidentiality agreements, if any, executed by the
forgoing persons may not be enforceable or provide meaningful
protection for our trade secrets or other proprietary
information in the event of unauthorized use or disclosure. If
we were to enforce a claim that a third party had illegally
obtained and was using our trade secrets, our enforcement
efforts would be expensive and time consuming, and the outcome
would be unpredictable. In addition, courts outside the United
States are sometimes less willing to protect trade secrets.
Moreover, if our
S-8
competitors independently develop information that is equivalent
to our trade secrets, it will be more difficult for us to
enforce our rights and our business could be harmed.
If we are not able to defend the patent or trade secret
protection position of our technologies and drug candidates,
then we will not be able to exclude competitors from developing
or marketing competing drugs, and we may not generate enough
revenue from product sales to justify the cost of development of
our drugs and to achieve or maintain profitability.
If we are sued for infringing intellectual property rights of
third parties, such litigation will be costly and time
consuming, and an unfavorable outcome would have a significant
adverse effect on our business.
Our ability to commercialize drugs depends on our ability to
sell such drugs without infringing the patents or other
proprietary rights of third parties. Numerous U.S. and foreign
issued patents and pending patent applications, owned by third
parties exist in the areas that we are exploring. In addition,
because patent applications can take several years to issue,
there may be currently pending applications, unknown to us,
which may later result in issued patents that our drug
candidates may infringe. There could also be existing patents of
which we are not aware that our drug candidates may
inadvertently infringe.
In particular, we are aware of an issued U.S. patent and at
least one pending U.S. patent application assigned to
Curis, Inc., or Curis, relating to certain compounds in the
quinazolinone class. Ispinesib falls into this class of
compounds. The Curis patent claims a method of use for
inhibiting signaling by what is called the hedgehog pathway
using certain such compounds. Curis has pending applications in
Europe, Japan, Australia and Canada with claims covering certain
quinazolinone compounds, compositions thereof and/or methods of
their use. We are also aware that two of the Australian
applications have been allowed and two of the European
applications have been granted. In Europe, Australia and
elsewhere, the grant of a patent may be opposed by one or more
parties. We and GSK have each opposed the granting of certain
such patents to Curis in Europe and in Australia. Curis or a
third party may assert that the sale of ispinesib may infringe
one or more of these or other patents. We believe that we have
valid defenses against the Curis patents if asserted against us.
However, we cannot guarantee that a court would find such
defenses valid or that such oppositions would be successful. We
have not attempted to obtain a license to this patent. If we
decide to obtain a license to this patent, we cannot guarantee
that we would be able to obtain such a license on commercially
reasonable terms, or at all.
In addition, we are aware of various issued U.S. and foreign
patents and pending U.S. and foreign patent applications
assigned to Fisher Scientific International, Inc., or Fisher
(formerly Cellomics, Inc.), relating to an automated method for
analyzing cells. Fisher or a third party may assert that our
Cytometrix technologies for cell analysis fall within the scope
of, and thus infringe, one or more of these patents. We have
received a letter from Fisher notifying us that Fisher believes
we may be practicing one or more of their patents and that
Fisher offers a use license for such patents through its
licensing program. We believe that we have persuasive defenses
to such an assertion. Moreover, the grant of Fishers
European patent has been opposed by another company. However, we
cannot guarantee that a court would find such defenses
persuasive or that such opposition would be successful. If we
decide to obtain a license to these patents, we cannot guarantee
that we would be able to obtain such a license on commercially
reasonable terms, or at all.
Other future products of ours may be impacted by patents of
companies engaged in competitive programs with significantly
greater resources (such as Merck & Co., Inc., or Merck,
and Bristol-Myers Squibb, or BMS). Further development of these
products could be impacted by these patents and result in the
expenditure of significant legal fees.
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If a third party claims that our actions infringe on their
patents or other proprietary rights, we could face a number of
issues that could seriously harm our competitive position,
including, but not limited to:
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infringement and other intellectual property claims that, with
or without merit, can be costly and time consuming to litigate
and can delay the regulatory approval process and divert
managements attention from our core business strategy; |
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substantial damages for past infringement which we may have to
pay if a court determines that our drugs or technologies
infringe a competitors patent or other proprietary rights; |
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a court prohibiting us from selling or licensing our drugs or
technologies unless the holder licenses the patent or other
proprietary rights to us, which it is not required to
do; and |
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if a license is available from a holder, we may have to pay
substantial royalties or grant cross licenses to our patents or
other proprietary rights. |
We may become involved in disputes with our strategic
partners over intellectual property ownership, and publications
by our research collaborators and scientific advisors could
impair our ability to obtain patent protection or protect our
proprietary information, which, in either case, would have a
significant impact on our business.
Inventions discovered under our strategic alliance agreements
become jointly owned by our strategic partners and us in some
cases, and the exclusive property of one of us in other cases.
Under some circumstances, it may be difficult to determine who
owns a particular invention, or whether it is jointly owned, and
disputes could arise regarding ownership of those inventions.
These disputes could be costly and time consuming, and an
unfavorable outcome would have a significant adverse effect on
our business if we were not able to protect or license rights to
these inventions. In addition, our research collaborators and
scientific advisors have contractual rights to publish our data
and other proprietary information, subject to our prior review.
Publications by our research collaborators and scientific
advisors containing such information, either with our permission
or in contravention of the terms of their agreements with us,
may impair our ability to obtain patent protection or protect
our proprietary information, which could significantly harm our
business.
To the extent we elect to fund the development of a drug
candidate or the commercialization of a drug at our expense, we
will need substantial additional funding.
The discovery, development and commercialization of novel small
molecule drugs focused on the cytoskeleton for the treatment of
a wide array of diseases is costly. As a result, to the extent
we elect to fund the development of a drug candidate or the
commercialization of a drug at our expense, we will need to
raise additional capital to:
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expand our research and development and technologies; |
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fund clinical trials and seek regulatory approvals; |
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build or access manufacturing and commercialization capabilities; |
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implement additional internal systems and infrastructure; |
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maintain, defend and expand the scope of our intellectual
property; and |
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hire and support additional management and scientific personnel. |
Our future funding requirements will depend on many factors,
including, but not limited to:
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the rate of progress and cost of our clinical trials and other
research and development activities; |
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the costs and timing of seeking and obtaining regulatory
approvals; |
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the costs associated with establishing manufacturing and
commercialization capabilities; |
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the costs of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights; |
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the costs of acquiring or investing in businesses, products and
technologies; |
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the effect of competing technological and market
developments; and |
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the payment and other terms and timing of any strategic
alliance, licensing or other arrangements that we may establish. |
Until we can generate a sufficient amount of product revenue to
finance our cash requirements, which we may never do, we expect
to finance future cash needs primarily through public or private
equity offerings, debt financings and strategic alliances. We
cannot be certain that additional funding will be available on
acceptable terms, or at all. If we are not able to secure
additional funding when needed, we may have to delay, reduce the
scope of or eliminate one or more of our clinical trials or
research and development programs or future commercialization
initiatives.
We have limited capacity to carry out our own clinical trials
in connection with the development of our drug candidates and
potential drug candidates, and to the extent we elect to develop
a drug candidate without a strategic partner we will need to
expand our development capacity, and we will require additional
funding.
The development of drug candidates is complicated, and requires
resources and experience for which we currently have limited
resources. Currently, we generally rely on our strategic
partners to carry out these activities for certain of our drug
candidates that are in clinical trials. We do not have a partner
for our cardiac myosin activator drug candidate,
CK-1827452, and, in the
event GSK elects to terminate its development efforts, we do not
have an alternative partner for our current and potential cancer
drug candidates. Pursuant to the amendment of our Collaboration
and License Agreement with GSK, we may initiate and conduct
clinical trials for our drug candidate
SB-743921 for the
treatment of non-Hodgkins lymphoma, Hodgkins
lymphoma, and multiple myeloma. For the clinical trials we
conduct with SB-743921
for these hematologic cancer indications, under the terms of our
amended agreement with GSK, we plan to rely on contractors for
the manufacture and distribution of clinical supplies. To the
extent we conduct clinical trials for a drug candidate without
support from a strategic partner, as we are doing with
CK-1827452, and as we
currently plan to do for
SB-743921, we will need
to develop additional skills, technical expertise and resources
necessary to carry out such development efforts on our own or
through the use of other third parties, such as contract
research organizations, or CROs.
If we utilize CROs, we will not have control over many aspects
of their activities, and will not be able to fully control the
amount or timing of resources that they devote to our programs.
These third parties also may not assign as high a priority to
our programs or pursue them as diligently as we would if we were
undertaking such programs ourselves, and therefore may not
complete their respective activities on schedule. CROs may also
have relationships with our competitors and potential
competitors, and may prioritize those relationships ahead of
their relationships with us. Typically, we would prefer to
qualify more than one vendor for each function performed outside
of our control, which could be time consuming and costly. The
failure of CROs to carry out development efforts on our behalf
according to our requirements and FDA or other regulatory
agencies standards, or our failure to properly coordinate
and manage such efforts, could increase the cost of our
operations and delay or prevent the development, approval and
commercialization of our drug candidates.
If we fail to develop the additional skills, technical expertise
and resources necessary to carry out the development of our drug
candidates, or if we fail to effectively manage our CROs
carrying out such development, the commercialization of our drug
candidates will be delayed or prevented.
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We currently have no marketing or sales staff, and if we are
unable to enter into or maintain strategic alliances with
marketing partners or if we are unable to develop our own sales
and marketing capabilities, we may not be successful in
commercializing our potential drugs.
We currently have no sales, marketing or distribution
capabilities. To commercialize our drugs that we determine not
to market on our own, we will depend on strategic alliances with
third parties, such as GSK, which have established distribution
systems and direct sales forces. If we are unable to enter into
such arrangements on acceptable terms, we may not be able to
successfully commercialize such drugs.
We plan to commercialize drugs on our own, with or without a
partner, that can be effectively marketed and sold in
concentrated markets that do not require a large sales force to
be competitive. To achieve this goal, we will need to establish
our own specialized sales force and marketing organization with
technical expertise and with supporting distribution
capabilities. Developing such an organization is expensive and
time consuming and could delay a product launch. In addition, we
may not be able to develop this capacity efficiently, or at all,
which could make us unable to commercialize our drugs.
To the extent that we are not successful in commercializing any
drugs ourselves or through a strategic alliance, our product
revenues will suffer, we will incur significant additional
losses and the price of our common stock will be negatively
affected.
We have no manufacturing capacity and depend on our partners
or contract manufacturers to produce our clinical trial drug
supplies for each of our drug candidates and potential drug
candidates, and anticipate continued reliance on contract
manufacturers for the development and commercialization of our
potential drugs.
We do not currently operate manufacturing facilities for
clinical or commercial production of our drug candidates or
potential drug candidates that are under development. We have
limited experience in drug formulation and manufacturing, and we
lack the resources and the capabilities to manufacture any of
our drug candidates on a clinical or commercial scale. As a
result, we currently rely on our partner, GSK, to manufacture
supply, store and distribute drug supplies for the ispinesib and
SB-743921 clinical
trials (and the planned
GSK-923295 clinical
trial). For our drug candidate
CK-1827452, and our
drug candidate
SB-743921 for
non-Hodgkins lymphoma, Hodgkins lymphoma, and
multiple myeloma, we currently rely on a limited number of
contract manufacturers, and, in particular, we expect to rely on
single-source contract manufacturers for the active
pharmaceutical ingredient and the drug product supply for our
clinical trials. In addition, we anticipate continued reliance
on a limited number of contract manufacturers. Any performance
failure on the part of our existing or future contract
manufacturers could delay clinical development or regulatory
approval of our drug candidates or commercialization of our
drugs, producing additional losses and depriving us of potential
product revenues.
Our drug candidates require precise, high quality manufacturing.
Our failure or our contract manufacturers failure to
achieve and maintain high manufacturing standards, including the
incidence of manufacturing errors, could result in patient
injury or death, product recalls or withdrawals, delays or
failures in product testing or delivery, cost overruns or other
problems that could seriously hurt our business. Contract drug
manufacturers often encounter difficulties involving production
yields, quality control and quality assurance, as well as
shortages of qualified personnel. These manufacturers are
subject to stringent regulatory requirements, including the
FDAs current good manufacturing practices regulations and
similar foreign laws, as well as ongoing periodic unannounced
inspections by the FDA, the U.S. Drug Enforcement Agency
and other regulatory agencies to ensure strict compliance with
current good manufacturing practices and other applicable
government regulations and corresponding foreign standards.
However, we do not have control over contract
manufacturers compliance with these regulations and
standards. If one of our contract manufacturers fails to
maintain compliance, the production of our drug candidates could
be interrupted, resulting in delays,
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additional costs and potentially lost revenues. Additionally,
our contract manufacturer must pass a preapproval inspection
before we can obtain marketing approval for any of our drug
candidates in development.
If the FDA or other regulatory agencies approve any of our drug
candidates for commercial sale, we will need to manufacture them
in larger quantities. To date, our drug candidates have been
manufactured only in small quantities for preclinical testing
and clinical trials. We may not be able to successfully increase
the manufacturing capacity, whether in collaboration with
contract manufacturers or on our own, for any of our drug
candidates in a timely or economic manner, or at all.
Significant scale-up of
manufacturing may require additional validation studies, which
the FDA must review and approve. If we are unable to
successfully increase the manufacturing capacity for a drug
candidate, the regulatory approval or commercial launch of any
related drugs may be delayed or there may be a shortage in
supply. Even if any contract manufacturer makes improvements in
the manufacturing process for our drug candidates, we may not
own, or may have to share, the intellectual property rights to
such improvements.
In addition, our existing and future contract manufacturers may
not perform as agreed or may not remain in the contract
manufacturing business for the time required to successfully
produce, store and distribute our drug candidates. In the event
of a natural disaster, business failure, strike or other
difficulty, we may be unable to replace such contract
manufacturer in a timely manner and the production of our drug
candidates would be interrupted, resulting in delays and
additional costs.
Switching manufacturers may be difficult and time consuming
because the number of potential manufacturers is limited and the
FDA must approve any replacement manufacturer or manufacturing
site prior to the manufacturing of our drug candidates. Such
approval would require new testing and compliance inspections.
In addition, a new manufacturer or manufacturing site would have
to be educated in, or develop substantially equivalent processes
for, production of our drugs after receipt of FDA approval. It
may be difficult or impossible for us to find a replacement
manufacturer on acceptable terms quickly, or at all.
We expect to expand our development, clinical research, sales
and marketing capabilities, and as a result, we may encounter
difficulties in managing our growth, which could disrupt our
operations.
We expect to have significant growth in expenditures, the number
of our employees and the scope of our operations, in particular
with respect to those drug candidates that we elect to develop
or commercialize independently or together with a partner. To
manage our anticipated future growth, we must continue to
implement and improve our managerial, operational and financial
systems, expand our facilities and continue to recruit and train
additional qualified personnel. Due to our limited resources, we
may not be able to effectively manage the expansion of our
operations or recruit and train additional qualified personnel.
The physical expansion of our operations may lead to significant
costs and may divert our management and business development
resources. Any inability to manage growth could delay the
execution of our business plans or disrupt our operations.
The failure to attract and retain skilled personnel could
impair our drug development and commercialization efforts.
Our performance is substantially dependent on the performance of
our senior management and key scientific and technical
personnel, particularly James H. Sabry, M.D., Ph.D.,
our President and Chief Executive Officer, Robert I. Blum, our
Executive Vice President, Corporate Development and Commercial
Operations and Chief Business Officer, Andrew A.
Wolff, M.D., F.A.C.C., our Senior Vice President, Clinical
Research and Chief Medical Officer, Sharon A. Surrey-Barbari,
our Senior Vice President, Finance and Chief Financial Officer,
David J. Morgans, Ph.D., our Senior Vice President of Drug
Discovery and Development, and Jay K. Trautman, Ph.D., our
Vice President of Discovery Biology and Technology. The
employment of these individuals and our other personnel is
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terminable at will with short or no notice. We carry key person
life insurance on James H. Sabry. The loss of the services of
any member of our senior management, scientific or technical
staff may significantly delay or prevent the achievement of drug
development and other business objectives by diverting
managements attention to transition matters and
identification of suitable replacements, and could have a
material adverse effect on our business, operating results and
financial condition. We also rely on consultants and advisors to
assist us in formulating our research and development strategy.
All of our consultants and advisors are either self-employed or
employed by other organizations, and they may have conflicts of
interest or other commitments, such as consulting or advisory
contracts with other organizations, that may affect their
ability to contribute to us.
In addition, we believe that we will need to recruit additional
executive management and scientific and technical personnel.
There is currently intense competition for skilled executives
and employees with relevant scientific and technical expertise,
and this competition is likely to continue. Our inability to
attract and retain sufficient scientific, technical and
managerial personnel could limit or delay our product
development efforts, which would adversely affect the
development of our drug candidates and commercialization of our
potential drugs and growth of our business.
Risks Related to Our Industry
Our competitors may develop drugs that are less expensive,
safer, or more effective, which may diminish or eliminate the
commercial success of any drugs that we may commercialize.
We compete with companies that are also developing drug
candidates that focus on the cytoskeleton, as well as companies
that have developed drugs or are developing alternative drug
candidates for cancer and cardiovascular, infectious and other
diseases. For example, with respect to cancer, BMS Taxol,
Sanofi Aventis Pharmaceuticals Inc.s Taxotere and generic
equivalents of Taxol are currently available on the market and
commonly used in cancer treatment. Furthermore, we are aware
that Merck, Chiron Corp., BMS and others are conducting research
focused on KSP and other mitotic kinesins. In addition, BMS,
Merck, Novartis and other pharmaceutical and biopharmaceutical
companies are developing other approaches to inhibiting mitosis.
With respect to heart failure, we are aware of a potentially
competitive approach being developed by Orion Pharma in
collaboration with Abbott Laboratories.
Our competitors may:
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develop drug candidates and market drugs that are less expensive
or more effective than our future drugs; |
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commercialize competing drugs before we or our partners can
launch any drugs developed from our drug candidates; |
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hold or obtain proprietary rights that could prevent us from
commercializing our products; |
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initiate or withstand substantial price competition more
successfully than we can; |
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have greater success in recruiting skilled scientific workers
from the limited pool of available talent; |
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more effectively negotiate third-party licenses and strategic
alliances; |
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take advantage of acquisition or other opportunities more
readily than we can; |
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develop drug candidates and market drugs that increase the
levels of safety or efficacy or alter other drug candidate
profile aspects that our drug candidates need to show in order
to obtain regulatory approval; and |
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introduce therapies or market drugs that render the market
opportunity for our potential drugs obsolete. |
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We will compete for market share against large pharmaceutical
and biotechnology companies and smaller companies that are
collaborating with larger pharmaceutical companies, new
companies, academic institutions, government agencies and other
public and private research organizations. Many of these
competitors, either alone or together with their partners, may
develop new drug candidates that will compete with ours. These
competitors may, and in certain cases do, operate larger
research and development programs or have substantially greater
financial resources than we do. Our competitors may also have
significantly greater experience in:
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developing drug candidates; |
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undertaking preclinical testing and clinical trials; |
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building relationships with key customers and opinion-leading
physicians; |
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obtaining and maintaining FDA and other regulatory approvals of
drug candidates; |
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formulating and manufacturing drugs; and |
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launching, marketing and selling drugs. |
If our competitors market drugs that are less expensive, safer
or more efficacious than our potential drugs, or that reach the
market sooner than our potential drugs, we may not achieve
commercial success. In addition, the life sciences industry is
characterized by rapid technological change. Because our
research approach integrates many technologies, it may be
difficult for us to stay abreast of the rapid changes in each
technology. If we fail to stay at the forefront of technological
change we may be unable to compete effectively. Our competitors
may render our technologies obsolete by advances in existing
technological approaches or the development of new or different
approaches, potentially eliminating the advantages in our drug
discovery process that we believe we derive from our research
approach and proprietary technologies.
The regulatory approval process is expensive, time consuming
and uncertain and may prevent our partners or us from obtaining
approvals to commercialize some or all of our
drug candidates.
The research, testing, manufacturing, selling and marketing of
drug candidates are subject to extensive regulation by the FDA
and other regulatory authorities in the United States and other
countries, which regulations differ from country to country.
Neither we nor our partners are permitted to market our
potential drugs in the United States until we receive approval
of an NDA from the FDA. Neither we nor our partners have
received marketing approval for any of Cytokinetics drug
candidates. Obtaining an NDA can be a lengthy, expensive and
uncertain process. In addition, failure to comply with the FDA
and other applicable foreign and U.S. regulatory
requirements may subject us to administrative or judicially
imposed sanctions. These include warning letters, civil and
criminal penalties, injunctions, product seizure or detention,
product recalls, total or partial suspension of production, and
refusal to approve pending NDAs, or supplements to
approved NDAs.
Regulatory approval of an NDA or NDA supplement is never
guaranteed, and the approval process typically takes several
years and is extremely expensive. The FDA also has substantial
discretion in the drug approval process. Despite the time and
expense exerted, failure can occur at any stage, and we could
encounter problems that cause us to abandon clinical trials or
to repeat or perform additional preclinical testing and clinical
trials. The number and focus of preclinical studies and clinical
trials that will be required for FDA approval varies depending
on the drug candidate, the disease or condition that the drug
candidate is designed to address, and the regulations applicable
to any particular drug candidate. The FDA can delay, limit or
deny approval of a drug candidate for many reasons, including:
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a drug candidate may not be safe or effective; |
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FDA officials may not find the data from preclinical testing and
clinical trials sufficient; |
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the FDA might not approve our or our contract
manufacturers processes or facilities; or |
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the FDA may change its approval policies or adopt new
regulations. |
If we or our partners receive regulatory approval for our
drug candidates, we will also be subject to ongoing FDA
obligations and continued regulatory review, such as continued
safety reporting requirements, and we may also be subject to
additional FDA post-marketing obligations, all of which may
result in significant expense and limit our ability to
commercialize our potential drugs.
Any regulatory approvals that we or our partners receive for our
drug candidates may be subject to limitations on the indicated
uses for which the drug may be marketed or contain requirements
for potentially costly post-marketing
follow-up studies. In
addition, if the FDA approves any of our drug candidates, the
labeling, packaging, adverse event reporting, storage,
advertising, promotion and record-keeping for the drug will be
subject to extensive regulatory requirements. The subsequent
discovery of previously unknown problems with the drug,
including adverse events of unanticipated severity or frequency,
or the discovery that adverse effects or toxicities previously
observed in preclinical research or clinical trials that were
believed to be minor actually constitute much more serious
problems, may result in restrictions on the marketing of the
drug, and could include withdrawal of the drug from the market.
The FDAs policies may change and additional government
regulations may be enacted that could prevent or delay
regulatory approval of our drug candidates. We cannot predict
the likelihood, nature or extent of adverse government
regulation that may arise from future legislation or
administrative action, either in the United States or abroad. If
we are not able to maintain regulatory compliance, we might not
be permitted to market our drugs and our business could suffer.
If physicians and patients do not accept our drugs, we may be
unable to generate significant revenue, if any.
Even if our drug candidates obtain regulatory approval,
resulting drugs, if any, may not gain market acceptance among
physicians, healthcare payors, patients and the medical
community. Even if the clinical safety and efficacy of drugs
developed from our drug candidates are established for purposes
of approval, physicians may elect not to recommend these drugs
for a variety of reasons including, but not limited to:
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timing of market introduction of competitive drugs; |
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clinical safety and efficacy of alternative drugs or treatments; |
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cost-effectiveness; |
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availability of coverage and reimbursement from health
maintenance organizations and other third-party payors; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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other potential disadvantages relative to alternative treatment
methods; and |
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insufficient marketing and distribution support. |
If our drugs fail to achieve market acceptance, we may not be
able to generate significant revenue and our business would
suffer.
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The coverage and reimbursement status of newly approved drugs
is uncertain and failure to obtain adequate coverage and
reimbursement could limit our ability to market any drugs we may
develop and decrease our ability to generate revenue.
There is significant uncertainty related to the coverage and
reimbursement of newly approved drugs. The commercial success of
our potential drugs in both domestic and international markets
is substantially dependent on whether third-party coverage and
reimbursement is available for the ordering of our potential
drugs by the medical profession for use by their patients.
Medicare, Medicaid, health maintenance organizations and other
third-party payors are increasingly attempting to contain
healthcare costs by limiting both coverage and the level of
reimbursement of new drugs, and, as a result, they may not cover
or provide adequate payment for our potential drugs. They may
not view our potential drugs as cost-effective and reimbursement
may not be available to consumers or may not be sufficient to
allow our potential drugs to be marketed on a competitive basis.
If we are unable to obtain adequate coverage and reimbursement
for our potential drugs, our ability to generate revenue may be
adversely affected. Likewise, legislative or regulatory efforts
to control or reduce healthcare costs or reform government
healthcare programs could result in lower prices or rejection of
coverage and reimbursement for our potential drugs. Changes in
coverage and reimbursement policies or healthcare cost
containment initiatives that limit or restrict reimbursement for
our drugs may cause our revenue to decline.
We may be subject to costly product liability claims and may
not be able to obtain adequate insurance.
If we conduct clinical trials in humans, we face the risk that
the use of our drug candidates will result in adverse effects.
We currently maintain product liability insurance in the amount
of $10.0 million with a $5,000 deductible per occurrence.
We cannot predict the possible harms or side effects that may
result from our clinical trials. We may not have sufficient
resources to pay for any liabilities resulting from a claim
excluded from, or beyond the limit of, our insurance coverage.
In addition, once we have commercially launched drugs based on
our drug candidates, we will face exposure to product liability
claims. This risk exists even with respect to those drugs that
are approved for commercial sale by the FDA and manufactured in
facilities licensed and regulated by the FDA. We intend to
secure limited product liability insurance coverage, but may not
be able to obtain such insurance on acceptable terms with
adequate coverage, or at reasonable costs. There is also a risk
that third parties that we have agreed to indemnify could incur
liability, or that third parties that have agreed to indemnify
us do not fulfill their obligations. Even if we were ultimately
successful in product liability litigation, the litigation would
consume substantial amounts of our financial and managerial
resources and may create adverse publicity, all of which would
impair our ability to generate sales of the affected product as
well as our other potential drugs. Moreover, product recalls may
be issued at our discretion or at the direction of the FDA,
other governmental agencies or other companies having regulatory
control for drug sales. If product recalls occur, they are
generally expensive and often have an adverse effect on the
image of the drugs being recalled as well as the reputation of
the drugs developer or manufacturer.
We may be subject to damages resulting from claims that we or
our employees have wrongfully used or disclosed alleged trade
secrets of their former employers.
Many of our employees were previously employed at universities
or other biotechnology or pharmaceutical companies, including
our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims
that these employees or we have inadvertently or otherwise used
or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend
against these claims. If we fail in defending such claims, in
addition to paying monetary damages, we may lose valuable
intellectual property rights or personnel. A loss of key
research personnel or their work product could hamper or prevent
our ability to commercialize certain potential drugs, which
could severely harm our business. Even if
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we are successful in defending against these claims, litigation
could result in substantial costs and be a distraction to
management.
We use hazardous chemicals and radioactive and biological
materials in our business. Any claims relating to improper
handling, storage or disposal of these materials could be time
consuming and costly.
Our research and development processes involve the controlled
use of hazardous materials, including chemicals and radioactive
and biological materials. Our operations produce hazardous waste
products. We cannot eliminate the risk of accidental
contamination or discharge and any resultant injury from those
materials. Federal, state and local laws and regulations govern
the use, manufacture, storage, handling and disposal of
hazardous materials. We may be sued for any injury or
contamination that results from our use or the use by third
parties of these materials. Compliance with environmental laws
and regulations is expensive, and current or future
environmental regulations may impair our research, development
and production efforts.
In addition, our partners may use hazardous materials in
connection with our strategic alliances. To our knowledge, their
work is performed in accordance with applicable biosafety
regulations. In the event of a lawsuit or investigation,
however, we could be held responsible for any injury caused to
persons or property by exposure to, or release of, these
hazardous materials used by these parties. Further, we may be
required to indemnify our partners against all damages and other
liabilities arising out of our development activities or drugs
produced in connection with these strategic alliances.
Our facilities in California are located near an earthquake
fault, and an earthquake or other types of natural disasters or
resource shortages could disrupt our operations and adversely
affect results.
Important documents and records, such as hard copies of our
laboratory books and records for our drug candidates and
compounds, are located in our corporate headquarters at a single
location in South San Francisco, California near active
earthquake zones. In the event of a natural disaster, such as an
earthquake, drought or flood, or localized extended outages of
critical utilities or transportation systems, we do not have a
formal business continuity or disaster recovery plan, and could
therefore experience a significant business interruption. In
addition, California from time to time has experienced shortages
of water, electric power and natural gas. Future shortages and
conservation measures could disrupt our operations and cause
expense, thus adversely affecting our business and financial
results.
Risks Related To Our Common Stock
We expect that our stock price will fluctuate significantly,
and you may not be able to resell your shares at or above your
investment price.
The stock market, particularly in recent years, has experienced
significant volatility, particularly with respect to
pharmaceutical, biotechnology and other life sciences company
stocks. The volatility of pharmaceutical, biotechnology and
other life sciences company stocks often does not relate to the
operating performance of the companies represented by the stock.
Factors that could cause volatility in the market price of our
common stock include, but are not limited to:
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results from, and any delays in, the clinical trials programs
for our drug candidates for the treatment of cancer and heart
failure, including the current clinical trials and proposed
clinical trials for ispinesib,
SB-743921 and
GSK-923295 for cancer,
and CK-1827452 for
heart failure, and including delays resulting from slower than
expected patient enrollment in such clinical trials; |
S-18
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delays in or discontinuation of the development of any of our
drug candidates by GSK; |
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failure or delays in entering additional drug candidates into
clinical trials; |
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failure or discontinuation of any of our research programs; |
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delays or other developments in establishing new strategic
alliances; |
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announcements concerning our strategic alliances with GSK or
AstraZeneca or future strategic alliances; |
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announcements concerning clinical trials being initiated or
conducted by the NCI; |
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issuance of new or changed securities analysts reports or
recommendations; |
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market conditions in the pharmaceutical, biotechnology and other
healthcare related sectors; |
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actual or anticipated fluctuations in our quarterly financial
and operating results; |
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developments or disputes concerning our intellectual property or
other proprietary rights; |
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introduction of technological innovations or new commercial
products by us or our competitors; |
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issues in manufacturing our drug candidates or drugs; |
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market acceptance of our drugs; |
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third-party healthcare coverage and reimbursement policies; |
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FDA or other U.S. or foreign regulatory actions affecting
us or our industry; |
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litigation or public concern about the safety of our drug
candidates or drugs; |
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additions or departures of key personnel; and |
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volatility in the stock prices of other companies in our
industry. |
These and other external factors may cause the market price and
demand for our common stock to fluctuate substantially, which
may limit or prevent investors from readily selling their shares
of common stock and may otherwise negatively affect the
liquidity of our common stock. In addition, when the market
price of a stock has been volatile, holders of that stock have
instituted securities class action litigation against the
company that issued the stock. If any of our stockholders
brought a lawsuit against us, we could incur substantial costs
defending the lawsuit. Such a lawsuit could also divert our
managements time and attention.
If the ownership of our common stock continues to be highly
concentrated, it may prevent you and other stockholders from
influencing significant corporate decisions and may result in
conflicts of interest that could cause our stock price to
decline.
As of December 31, 2005, our executive officers, directors
and their affiliates beneficially owned or controlled
approximately 37% percent of the outstanding shares of our
common stock (after giving effect to the exercise of all
outstanding vested and unvested options and warrants).
Accordingly, these executive officers, directors and their
affiliates, acting as a group, will have substantial influence
over the outcome of corporate actions requiring stockholder
approval, including the election of directors, any merger,
consolidation or sale of all or substantially all of our assets
or any other significant corporate transactions. These
stockholders may also delay or prevent a change of control of
us, even if such a change of control would benefit our other
stockholders. The significant concentration of stock ownership
may adversely affect the trading price of our common stock due
to investors perception that conflicts of interest may
exist or arise.
S-19
Future sales of common stock by our existing stockholders may
cause our stock price to fall.
The market price of our common stock could decline as a result
of sales of common stock by stockholders who held shares of our
capital stock prior to this offering, or the perception that
these sales could occur. These sales might also make it more
difficult for us to sell equity securities at a time and price
that we deem appropriate.
Evolving regulation of corporate governance and public
disclosure may result in additional expenses and continuing
uncertainty.
Changing laws, regulations and standards relating to corporate
governance and public disclosure, including the Sarbanes-Oxley
Act of 2002, new Securities and Exchange Commission regulations
and Nasdaq National Market rules are creating uncertainty for
public companies. We are presently evaluating and monitoring
developments with respect to new and proposed rules and cannot
predict or estimate the amount of the additional costs we may
incur or the timing of such costs. For example, compliance with
the internal control requirements of Sarbanes-Oxley
Section 404 for the year ended December 31, 2005
requires the commitment of significant resources to document and
test the adequacy of our internal control over financial
reporting. While we are expending significant resources on the
required documentation and testing procedures required by
Section 404, we can provide no assurance as to conclusions
of management or by our independent registered public accounting
firm with respect to the effectiveness of our internal control
over financial reporting. These new or changed laws, regulations
and standards are subject to varying interpretations, in many
cases due to their lack of specificity, and, as a result, their
application in practice may evolve over time as new guidance is
provided by regulatory and governing bodies. This could result
in continuing uncertainty regarding compliance matters and
higher costs necessitated by ongoing revisions to disclosure and
governance practices. We are committed to maintaining high
standards of corporate governance and public disclosure. As a
result, we intend to invest the resources necessary to comply
with evolving laws, regulations and standards, and this
investment may result in increased general and administrative
expenses and a diversion of management time and attention from
revenue-generating activities to compliance activities. If our
efforts to comply with new or changed laws, regulations and
standards differ from the activities intended by regulatory or
governing bodies, due to ambiguities related to practice or
otherwise, regulatory authorities may initiate legal proceedings
against us and our reputation and business may be harmed.
Volatility in the stock prices of other companies may
contribute to volatility in our stock price.
The stock market in general, and Nasdaq and the market for
technology companies in particular, have experienced significant
price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of those
companies. Further, there has been particular volatility in the
market prices of securities of early stage and development stage
life sciences companies. These broad market and industry factors
may seriously harm the market price of our common stock,
regardless of our operating performance. In the past, following
periods of volatility in the market price of a companys
securities, securities class action litigation has often been
instituted. A securities class action suit against us could
result in substantial costs, potential liabilities and the
diversion of managements attention and resources.
We have never paid dividends on our capital stock, and we do
not anticipate paying any cash dividends in the foreseeable
future.
We have paid no cash dividends on any of our classes of capital
stock to date and we currently intend to retain our future
earnings, if any, to fund the development and growth of our
businesses. In addition, the terms of existing or any future
debts may preclude us from paying these dividends.
S-20
Our common stock is thinly traded and there may not be an
active, liquid trading market for our common stock.
There is no guarantee that an active trading market for our
common stock will be maintained on Nasdaq, or that the volume of
trading will be sufficient to allow for timely trades. Investors
may not be able to sell their shares quickly or at the latest
market price if trading in our stock is not active or if trading
volume is limited. In addition, if trading volume in our common
stock is limited, trades of relatively small numbers of shares
may have a disproportionate effect on the market price of our
common stock.
Risks Related To The Committed Equity Financing Facility With
Kingsbridge
Our committed equity financing facility with Kingsbridge may
not be available to us if we elect to make a draw down, may
require us to make additional blackout or other
payments to Kingsbridge, and may result in dilution to our
stockholders.
In October 2005, we entered into a committed equity financing
facility, or CEFF, with Kingsbridge. The CEFF entitles us to
sell and obligates Kingsbridge to purchase, from time to time
over a period of three years, shares of our common stock for
cash consideration up to an aggregate of $75 million,
subject to certain conditions and restrictions. Kingsbridge will
not be obligated to purchase shares under the CEFF unless
certain conditions are met, which include a minimum price for
our common stock; the accuracy of representations and warranties
made to Kingsbridge; compliance with laws; effectiveness of a
registration statement registering for resale the shares of
common stock to be issued in connection with the CEFF and the
continued listing of our stock on the Nasdaq National Stock
market. In addition, Kingsbridge is permitted to terminate the
CEFF if it determines that a material and adverse event has
occurred affecting our business, operations, properties or
financial condition and if such condition continues for a period
of 10 days from the date Kingsbridge provides us notice of
such material and adverse event. If we are unable to access
funds through the CEFF, or if the CEFF is terminated by
Kingsbridge, we may be unable to access capital on favorable
terms or at all.
We are entitled, in certain circumstances, to deliver a blackout
notice to Kingsbridge to suspend the use of the resale
registration statement and prohibit Kingsbridge from selling
shares under the resale registration statement. If we deliver a
blackout notice in the 15 trading days following the settlement
of a draw down, or if the resale registration statement is not
effective in circumstances not permitted by the agreement, then
we must make a payment to Kingsbridge, or issue Kingsbridge
additional shares in lieu of this payment, calculated on the
basis of the number of shares held by Kingsbridge (exclusive of
shares that Kingsbridge may hold pursuant to exercise of the
Kingsbridge warrant) and the change in the market price of our
common stock during the period in which the use of the
registration statement is suspended. If the trading price of our
common stock declines during a suspension of the resale
registration statement, the blackout or other payment could be
significant.
Should we sell shares to Kingsbridge under the CEFF, or issue
shares in lieu of a blackout payment, it will have a dilutive
effective on the holdings of our current stockholders, and may
result in downward pressure on the price of our common stock. If
we draw down under the CEFF, we will issue shares to Kingsbridge
at a discount of up to 10 percent from the volume weighted
average price of our common stock. If we draw down amounts under
the CEFF when our share price is decreasing, we will need to
issue more shares to raise the same amount than if our stock
price was higher. Issuances in the face of a declining share
price will have an even greater dilutive effect than if our
share price were stable or increasing, and may further decrease
our share price.
S-21
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
In addition to the other information contained or incorporated
by reference in this prospectus supplement and the accompanying
prospectus, you should carefully consider the risk factors
disclosed in this prospectus supplement and the accompanying
prospectus when evaluating an investment in our securities. This
prospectus supplement contains forward-looking statements that
are based upon current expectations that are within the meaning
of the Private Securities Reform Act of 1995. It is the
Companys intent that such statements be protected by the
safe harbor created thereby.
Forward-looking statements involve risks and uncertainties and
our actual results and the timing of events may differ
significantly from the results discussed in the forward-looking
statements. Examples of such forward-looking statements include,
but are not limited to, statements regarding:
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the initiation and scope clinical trials and development for our
drug candidates and potential drug candidates; |
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our plans or ability to commercialize drugs, with or without a
partner; |
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increasing expenditures and losses; |
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the sufficiency of existing resources to fund our operations for
at least the next 12 months; |
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expansion of the scope and size of research and development
efforts; |
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potential competitors; |
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our needs for additional financing; |
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expected future sources of revenue and capital; |
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protection of our intellectual property; |
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issuance of shares of our common stock under the CEFF; and |
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increasing the number of our employees and recruiting additional
key personnel. |
Factors that could cause actual results or conditions to differ
from those anticipated by these and other forward-looking
statements include those more fully described in the Risk
Factors section of this prospectus supplement and
accompanying prospectus and elsewhere in this prospectus
supplement and in the accompanying prospectus. We undertake no
obligation to update or revise these forward-looking statements
to reflect events or circumstances after the date of this
prospectus supplement except as required by law.
USE OF PROCEEDS
Based upon an offering price of $6.60 per share, we
estimate that the net proceeds we will receive from the sale of
shares of our common stock in this offering will be
approximately $31.9 million, after deducting the
advisors fee and estimated offering expenses. We will
retain broad discretion over the use of the net proceeds from
the sale of our common stock offered hereby. We currently intend
to use the net proceeds from the sale of our common stock in
this offering primarily for:
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research and development, including clinical trials for our
product candidates; and |
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working capital and other general corporate purposes. |
The amounts and timing of the expenditures may vary
significantly depending on numerous factors, such as the
progress of our research and development efforts, technological
advances and the competitive environment for our products. We
may also use a portion of the net proceeds to acquire or invest
in complementary businesses, products and technologies. Although
we currently
S-22
have no material agreements or commitments with respect to
acquisitions, we evaluate acquisition opportunities and engage
in related discussions from time to time.
Pending the use of the net proceeds, we intend to invest the net
proceeds in short-term, interest-bearing, investment-grade
securities.
DESCRIPTION OF COMMON STOCK
Please read the information discussed under the heading
Description of Capital Stock beginning on
page 21 of the accompanying prospectus dated June 14,
2005. On January 17, 2006, approximately
30,544,730 shares of our common stock were outstanding.
Upon completion of the sale under this prospectus supplement,
approximately 35,544,730 shares of our common stock will be
outstanding, based on the approximate number of shares of common
stock issued and outstanding as of January 17, 2006. As of
September 30, 2005, 28,660,743 shares of common stock
were issued and outstanding.
DILUTION
Pro forma net tangible book value dilution per share to
investors in this offering represents the difference between the
amount per share paid by these investors and the net tangible
book value per share of our common stock immediately after
completion of this offering. After giving effect to the sale of
the 5,000,000 shares of our common stock being offered in
this offering, assuming a purchase price of $6.60 per share
and after deducting our estimated offering expenses, our net
tangible book value as of September 30, 2005 would have
been $3.27 per share. This amount represents an immediate
increase in net tangible book value of $0.54 per share to
existing stockholders and an immediate dilution in net tangible
book value of $3.33 per share to investors in this offering
as illustrated in the following table:
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Assumed price per share
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$ |
6.60 |
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Net tangible book value per share
as of September 30, 2005
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$ |
2.73 |
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Increase in net tangible book value
per share attributable to this offering
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$ |
0.54 |
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Pro forma net tangible book value
per share as of September 30, 2005 after giving effect to
this offering
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3.27 |
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Dilution per share to investors in
this offering
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$ |
3.33 |
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The number of shares of our common stock in the computations
above excludes the following options and warrants outstanding as
of September 30, 2005:
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3,254,709 shares of our common stock issuable upon exercise
of outstanding options granted under our stock option plans at a
weighted average exercise price of $4.17 per share; |
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50,000 shares of our common stock issuable upon exercise of
outstanding warrants at a weighted average price of
$5.80 per share; |
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96,000 shares of our common stock issuable in relation to
planned purchases under our 2004 Employee Stock Purchase
Plan; and |
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44,000 shares of our outstanding common stock subject to
our repurchase rights. |
PLAN OF DISTRIBUTION
This is a best efforts offering being made directly by
Cytokinetics, without an underwriter or placement agent. We are
not required to sell any specific number or dollar amount of
securities in
S-23
this offering, but will use our best efforts to sell the
securities offered. We will receive all of the proceeds from any
securities sold in this offering. If we sell the maximum number
of shares offered by this prospectus supplement, the total gross
offering proceeds to us, before offering expenses (described
below), will be $32,000,000.
We expect to enter into a stock purchase agreement with one or
more institutional investors for the sale and purchase of the
shares offered under this prospectus supplement. Any such stock
purchase agreement will contain customary representations and
warranties by us and each of the purchasers, and provides that
the obligations of the purchasers to purchase the shares will be
subject to certain customary conditions precedent.
This offering will continue until the earlier of the sale of all
shares offered by this prospectus supplement or January 31,
2006. We expect that closing will generally occur within three
business days following our entry into definitive stock purchase
agreements with investors participating in this offering.
Expenses of the Offering
We estimate that the net total expenses of the offering will be
approximately $1,070,000, which includes an advisors fee
in the amount of $1,000,000 that we have agreed to pay to a
registered broker-dealer, assuming that the maximum number of
shares covered by this prospectus supplement are sold.
Nasdaq National Market Listing
Our common stock is listed on the Nasdaq National Market under
the symbol CYTK.
LEGAL MATTERS
The validity of the common stock offered hereby will be passed
upon for us by Wilson Sonsini Goodrich & Rosati,
Professional Corporation, Palo Alto, California.
S-24
PROSPECTUS
$100,000,000
Cytokinetics, Incorporated
Common Stock
Preferred Stock
Warrants
From time to time, we may sell any of the securities listed
above. All of the securities listed above may be sold separately
or as units with other securities. We will specify in an
accompanying prospectus supplement the terms of any offering.
Our common stock is traded on the Nasdaq National Market under
the trading symbol CYTK. On June 13, 2005 the
last reported sale price of our common stock on the Nasdaq
National Market was $5.18 per share.
You should read this prospectus, any prospectus supplement and
the documents incorporated by reference in this prospectus and
any prospectus supplement carefully before you invest. This
prospectus may not be used to offer or sell any securities
unless accompanied by a prospectus supplement.
Investing in our securities involves a high degree of risk.
You should carefully consider the Risk Factors beginning on
page 2 of this prospectus before you make an investment
decision.
The securities offered by this prospectus may be offered in
amounts, at prices and at terms determined at the time of the
offering and may be sold directly by us to investors, through
agents designated from time to time or to or through
underwriters or dealers. We will set forth the names of any
underwriters or agents in the accompanying prospectus
supplement. For additional information on the methods of sale,
you should refer to the section entitled Plan of
Distribution. The net proceeds we expect to receive from
such sale will also be set forth in a prospectus supplement.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is June 14, 2005
Table of Contents
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No person has been authorized to give any information or make
any representations in connection with this offering other than
those contained or incorporated by reference in this prospectus
and any accompanying prospectus supplement in connection with
the offering described herein and therein, and, if given or
made, such information or representations must not be relied
upon as having been authorized by us. Neither this prospectus
nor any prospectus supplement shall constitute an offer to sell
or a solicitation of an offer to buy offered securities in any
jurisdiction in which it is unlawful for such person to make
such an offering or solicitation. Neither the delivery of this
prospectus or any prospectus supplement nor any sale made
hereunder shall under any circumstances imply that the
information contained or incorporated by reference herein or in
any prospectus supplement is correct as of any date subsequent
to the date hereof or of such prospectus supplement.
i
SUMMARY
The following summary is qualified in its entirety by the
more detailed information, including our consolidated financial
statements and related notes incorporated in this prospectus by
reference. You should carefully consider the information set
forth in this entire prospectus, including the Risk
Factors section, the applicable prospectus supplement for
such securities and the other documents we refer to and
incorporate by reference. Unless the context otherwise requires,
the terms Cytokinetics, we,
us and our refer to Cytokinetics,
Incorporated, a Delaware corporation.
This prospectus is part of a registration statement that we
filed with the Securities and Exchange Commission, or SEC, using
a shelf registration process. Under this shelf
registration process, we may sell any combination of the
securities described in this prospectus, in one or more
offerings, up to an aggregate offering price of $100,000,000.
This prospectus provides you with a general description of the
securities we may offer. Each time we sell any securities under
this prospectus, we will provide a prospectus supplement that
will contain more specific information about the terms of those
securities. This prospectus does not contain all of the
information included in the registration statement. For a more
complete understanding of the offering of the securities, you
should refer to the registration statement, including its
exhibits. The prospectus supplement may also add, update or
change information contained in this prospectus. You should read
both this prospectus and any prospectus supplement, including
the risk factors, together with the additional information
described under the headings Where You Can Find
Information and Information Incorporated by
Reference.
Cytokinetics, Incorporated
Cytokinetics, Incorporated is a leading biopharmaceutical
company focused on the discovery, development and
commercialization of novel small molecule drugs that
specifically target the cytoskeleton. A number of commonly used
drugs and a growing body of research validate the role the
cytoskeleton plays in a wide array of human diseases. Our focus
on the cytoskeleton enables us to develop novel and potentially
safer and more effective drugs for the treatment of these
diseases. We believe that our cell biology driven approach and
proprietary technologies enhance the speed, efficiency and yield
of our drug discovery and development process. To date, our
unique approach has produced two cancer drug candidates, a
potential drug candidate for the treatment of congestive heart
failure, and other research programs addressing a variety of
other disease areas including high blood pressure and asthma.
We were incorporated in Delaware in August 1997. Our principal
executive offices are located at 280 East Grand Avenue, South
San Francisco, California 94080 and our telephone number at
that address is (650) 624-3000.
CYTOKINETICS, our logo used alone and with the mark
CYTOKINETICS, and CYTOMETRIX are our registered service marks
and trademarks. Other service marks, trademarks and trade names
referred to in this prospectus are the property of their
respective owners.
1
RISK FACTORS
An investment in our securities involves a high degree of
risk. You should carefully consider the risks described below
before making an investment decision. You should also refer to
the other information in this prospectus, including our
financial statements and the related notes incorporated by
reference into this prospectus. The risks and uncertainties
described below are not the only risks and uncertainties we
face. Additional risks and uncertainties not presently known to
us or that we currently deem immaterial also may impair our
business operations. If any of the following risks actually
occur, our business, results of operations and financial
condition could suffer. In that event, the trading price of the
securities being offered by this prospectus could decline, and
you may lose all or part of your investment in such securities.
The risks discussed below also include forward-looking
statements and our actual results may differ substantially from
those discussed in these forward-looking statements.
Risks Related to Our Business
Our initial drug candidates are in the early stages of
clinical testing and we have a history of significant losses and
may not achieve or sustain profitability and, as a result, you
may lose all or part of your investment.
Our initial drug candidates are in the early stages of clinical
testing and we must conduct significant additional clinical
trials before we can seek the regulatory approvals necessary to
begin commercial sales of our drugs. We have incurred operating
losses in each year since our inception in 1997 due to costs
incurred in connection with our research and development
activities and general and administrative costs associated with
our operations. We expect to incur increasing losses for at
least several years, as we continue our research activities and
conduct development of, and seek regulatory approvals for, our
initial drug candidates, and commercialize any approved drugs.
If our initial drug candidates fail in clinical trials or do not
gain regulatory approval, or if our drugs do not achieve market
acceptance, we will not be profitable. If we fail to become and
remain profitable, or if we are unable to fund our continuing
losses, you could lose all or part of your investment.
We have never generated, and may never generate, revenues
from commercial sales of our drugs and we may not have drugs to
market for at least several years, if ever.
We currently have no drugs for sale and we cannot guarantee that
we will ever have marketable drugs. We must demonstrate that our
drug candidates satisfy rigorous standards of safety and
efficacy to the Food and Drug Administration, or FDA, and other
regulatory authorities in the U.S. and abroad. We and our
partners will need to conduct significant additional research,
preclinical testing and clinical testing, before we or our
partners can file applications with the FDA or other regulatory
authorities for approval of our drug candidates. In addition, to
compete effectively, our drugs must be easy to use,
cost-effective and economical to manufacture on a commercial
scale. We may not achieve any of these objectives. Ispinesib,
our most advanced drug candidate for the treatment of cancer,
and SB-743921, our
second drug candidate for the treatment of cancer, are currently
our only drug candidates in clinical trials and we cannot be
certain that the clinical development of these or any other drug
candidate in preclinical testing or clinical development will be
successful, that they will receive the regulatory approvals
required to commercialize them, or that any of our other
research programs will yield a drug candidate suitable for entry
into clinical trials. Our commercial revenues, if any, will be
derived from sales of drugs that we do not expect to be
commercially available for several years, if at all. The
development of one or both of these drug candidates may be
discontinued at any stage of our clinical trials programs and we
may not generate revenue from either of these drug candidates.
We have funded all of our operations and capital expenditures
with proceeds from both private and public sales of our equity
securities, strategic alliances with GlaxoSmithKline, or GSK,
2
AstraZeneca and others, equipment financings, interest on
investments and government grants. To meet our future cash
requirements, we may raise funds through public or private
equity offerings, debt financings or strategic alliances. To the
extent that we raise additional funds by issuing equity
securities, our stockholders may experience additional dilution.
To the extent that we raise additional funds through debt
financing, if available, such financing may involve covenants
that restrict our business activities. To the extent that we
raise additional funds through strategic alliance and licensing
arrangements, we will likely have to relinquish valuable rights
to our technologies, research programs or drug candidates, or
grant licenses on terms that may not be favorable to us. In
addition, we cannot assure you that any such funding, if needed,
will be available on attractive terms, or at all.
Clinical trials may fail to demonstrate the safety and
efficacy of our drug candidates, which could prevent or
significantly delay completion of clinical development and
regulatory approval.
Prior to receiving approval to commercialize any of our drug
candidates, we must demonstrate with substantial evidence from
well-controlled clinical trials, and to the satisfaction of the
FDA and other regulatory authorities in the U.S. and abroad,
that such drug candidate is both safe and effective. Before we
can commence clinical trials, we must demonstrate through
preclinical studies satisfactory product chemistry, formulation,
stability and toxicity levels in order to file an
investigational new drug application, or IND, (or the foreign
equivalent of an IND) to commence clinical trials. In clinical
trials we will need to demonstrate efficacy for the treatment of
specific indications and monitor safety throughout the clinical
development process. Long-term safety and efficacy have not yet
been demonstrated in clinical trials for any of our drug
candidates, and satisfactory chemistry, formulation, stability
and toxicity levels have not yet been demonstrated for our drug
candidates or compounds that are currently the subject of
preclinical studies. If our preclinical studies, clinical trials
or future clinical trials are unsuccessful, our business and
reputation would be harmed and our stock price would be
negatively affected.
All of our drug candidates are prone to the risks of failure
inherent in drug development. Preclinical studies may not yield
results that would satisfactorily support the filing of an IND
or comparable regulatory filing abroad with respect to our drug
candidates, and, even if these applications would be or have
been filed with respect to our drug candidates, the results of
preclinical studies do not necessarily predict the results of
clinical trials. Similarly, early-stage clinical trials do not
predict the results of later-stage clinical trials, including
the safety and efficacy profiles of any particular drug
candidate. In addition, there can be no assurance that the
design of our clinical trials is focused on appropriate tumor
types, patient populations, dosing regimens or other variables
which will result in obtaining the desired efficacy data to
support regulatory approval to commercialize the drug. Even if
we believe the data collected from clinical trials of our drug
candidates are promising, such data may not be sufficient to
support approval by the FDA or any other U.S. or foreign
regulatory authority. Preclinical and clinical data can be
interpreted in different ways. Accordingly, FDA officials, or
officials from foreign regulatory authorities, could interpret
the data in different ways than we or our partners do, which
could delay, limit or prevent regulatory approval.
Administering any of our drug candidates or potential drug
candidates that are the subject of preclinical studies to
animals may produce undesirable side effects, also known as
adverse effects. Toxicities and adverse effects that we have
observed in preclinical studies for some compounds in a
particular research program may recur in preclinical studies of
other compounds from the same program. Such toxicities or
adverse effects could delay or prevent the filing of an IND or
comparable regulatory filing abroad with respect to such drug
candidates or potential drug candidates. In Phase I
clinical trials of ispinesib, the dose limiting toxicity was
neutropenia, a decrease in the number of a certain type of white
blood cell that results in an increase in susceptibility to
infection. In clinical trials, administering any of our drug
candidates to humans may produce adverse effects. These adverse
effects could interrupt, delay or halt clinical trials of our
drug candidates and could result in
3
the FDA or other regulatory authorities denying approval of our
drug candidates for any or all targeted indications. The FDA,
other regulatory authorities, our partners or we may suspend or
terminate clinical trials at any time. Even if one or more of
our drug candidates were approved for sale, the occurrence of
even a limited number of toxicities or adverse effects when used
in large populations may cause the FDA to impose restrictions
on, or prevent, the further marketing of such drugs. Indications
of potential adverse effects or toxicities which may occur in
clinical trials and which we believe are not significant during
the course of such clinical trials may later turn out to
actually constitute serious adverse effects or toxicities when a
drug has been used in large populations or for extended periods
of time. Any failure or significant delay in completing
preclinical studies or clinical trials for our drug candidates,
or in receiving and maintaining regulatory approval for the sale
of any drugs resulting from our drug candidates, may severely
harm our reputation and business.
Clinical trials are expensive, time consuming and subject to
delay.
Clinical trials are very expensive and difficult to design and
implement, especially in the cancer and congestive heart failure
indications that we are pursuing, in part because they are
subject to rigorous requirements. The clinical trial process is
also time consuming. According to industry sources, the entire
drug development and testing process takes on average 12 to
15 years. According to industry studies, the fully
capitalized resource cost of new drug development averages
approximately $800 million, however, individual clinical
trials and individual drug candidates may incur a range of costs
above or below this average. We estimate that clinical trials of
our most advanced drug candidates will continue for several
years, but may take significantly longer to complete. The
commencement and completion of our clinical trials could be
delayed or prevented by several factors, including, but not
limited to:
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delays in obtaining regulatory approvals to commence a study; |
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delays in identifying and reaching agreement on acceptable terms
with prospective clinical trial sites; |
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slower than expected rates of patient recruitment and
enrollment, including as a result of the introduction of
alternative therapies or drugs by others; |
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lack of effectiveness during clinical trials; |
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unforeseen safety issues; |
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uncertain dosing issues; |
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introduction of new therapies or changes in standards of
practice or regulatory guidance that render our clinical trial
endpoints or the targeting of our proposed indications obsolete; |
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inability to monitor patients adequately during or after
treatment; and |
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inability or unwillingness of medical investigators to follow
our clinical protocols. |
We do not know whether planned clinical trials will begin on
time, will need to be restructured or will be completed on
schedule, if at all. Significant delays in clinical trials will
impede our ability to commercialize our drug candidates and
generate revenue and could significantly increase our
development costs.
We depend on GSK for the conduct, completion and funding of
the clinical development and commercialization of our current
drug candidates for the treatment of cancer.
Under our strategic alliance with GSK, GSK is currently
responsible for the clinical development and regulatory approval
of our cancer drug candidates, ispinesib and
SB-743921. GSK is
responsible for filing applications with the FDA or other
regulatory authorities for approval of these drug candidates,
and will be the owner of any marketing approvals issued by the
FDA or other regulatory authorities. If the FDA or other
regulatory authorities approve these drug candidates, GSK
4
will also be responsible for the marketing and sale of these
drugs. Because GSK is responsible for these functions, we cannot
control whether GSK will devote sufficient attention and
resources to the clinical trials program or will proceed in an
expeditious manner. Under certain circumstances, GSK has
discretion to elect whether to pursue the development of our
drug candidates or to abandon the clinical trial programs, and,
after June 20, 2006, GSK may terminate our strategic
alliance for any reason upon six months prior notice. These
decisions are outside our control. Because both of our cancer
drug candidates being developed by GSK act through inhibition of
kinesin spindle protein, or KSP, a protein that is a member of a
class of cytoskeletal proteins called mitotic kinesins that
regulate DNA division, or mitosis, during cell division, it is
possible that GSK may elect to proceed with the development of
only one such drug candidate. If GSK were to elect to proceed
with the development of
SB-743921 in lieu of
ispinesib, and because
SB-743921 is at an
earlier stage of clinical development than ispinesib, the
approval, if any, of a new drug application, or NDA, with
respect to a drug candidate from our cancer program would be
delayed. In particular, if the initial clinical results of some
of our early clinical trials do not meet GSKs
expectations, GSK may elect to terminate further development of
one or both drug candidates, even though the actual number of
patients that have been treated is relatively small. Abandonment
of one or both of ispinesib and
SB-743921 by GSK would
result in a delay in or prevent us from commercializing such
drug candidates, and would delay or prevent our ability to
generate revenues. Disputes may arise between us and GSK, which
may delay or cause termination of the clinical trials program,
result in significant litigation or arbitration, or cause GSK to
act in a manner that is not in our best interest. If development
of our drug candidates does not progress for these or any other
reasons, we would not receive further milestone payments from
GSK. GSK also has the contractual right to reduce its funding of
our FTEs for this program at their discretion, subject to
certain agreed minimum levels, in the beginning of each contract
year based on the activities of the agreed upon research plan.
Even if the FDA or other regulatory agencies approve one or more
of our drug candidates, GSK may elect not to proceed with the
commercialization of such drugs, or may elect to pursue
commercialization of one drug but not others, and these
decisions are outside our control. In such event, or in the
event that GSK abandons development of any drug candidate prior
to regulatory approval, we would have to undertake and fund the
clinical development of our drug candidates or commercialization
of our drugs, seek a new partner for clinical development or
commercialization, or curtail or abandon the clinical
development or commercialization programs. If we were unable to
do so on acceptable terms, or at all, our business would be
harmed, and the price of our common stock and other securities,
if any, would be negatively affected.
If we fail to enter into and maintain successful strategic
alliances for certain of our drug candidates, we may have to
reduce or delay our drug candidate development or increase our
expenditures.
Our strategy for developing, manufacturing and commercializing
certain of our drug candidates currently requires us to enter
into and successfully maintain strategic alliances with
pharmaceutical companies or other industry participants to
advance our programs and reduce our expenditures on each
program. We have formed a strategic alliance with GSK with
respect to ispinesib,
SB-743921 and certain
other research activities. However, we may not be able to
negotiate additional strategic alliances on acceptable terms, if
at all. If we are not able to maintain our existing strategic
alliances or establish and maintain additional strategic
alliances, we may have to limit the size or scope of, or delay,
one or more of our drug development programs or research
programs or undertake and fund these programs ourselves. If we
elect to increase our expenditures to fund drug development
programs or research programs on our own, we will need to obtain
additional capital, which may not be available on acceptable
terms, or at all.
5
The success of our development efforts depends in part on the
performance of our partners and the National Cancer Institute,
or NCI, over which we have little or no control.
Our ability to commercialize drugs that we develop with our
partners and that generate royalties from product sales depends
on our partners abilities to assist us in establishing the
safety and efficacy of our drug candidates, obtaining and
maintaining regulatory approvals and achieving market acceptance
of the drugs once commercialized. Our partners may elect to
delay or terminate development of one or more drug candidates,
independently develop drugs that could compete with ours or fail
to commit sufficient resources to the marketing and distribution
of drugs developed through their strategic alliances with us. It
is likely that our partners will not proceed with the
development and commercialization of our drug candidates with
the same degree of urgency as we would because of other
priorities they face. In particular, we are relying on the NCI
to conduct several important clinical trials of our drug
candidates. The NCI is a government agency and there can be no
assurance that the NCI will not modify its plans to conduct such
clinical trials or will proceed with such clinical trials
diligently. If our partners fail to perform as we expect, our
potential for revenue from drugs developed through our strategic
alliances could be dramatically reduced.
Our focus on the discovery of drug candidates directed
against specific proteins and pathways within the cytoskeleton
is unproven, and we do not know whether we will be able to
develop any drug candidates of commercial value.
We believe that our focus on drug discovery and development
directed at the cytoskeleton is novel and unique to us. While a
number of commonly used drugs and a growing body of research
validate the importance of the cytoskeleton in the origin and
progression of a number of diseases, no existing drugs
specifically and directly interact with the cytoskeletal
proteins and pathways that our drug candidates seek to modulate.
As a result, we cannot be certain that our drug candidates will
appropriately modulate targeted cytoskeletal proteins and
pathways or produce commercially viable drugs that safely and
effectively treat cancer, congestive heart failure or other
diseases, or that the results we have seen in preclinical models
will translate into similar results in humans. In addition, even
if we are successful in developing and receiving regulatory
approval for a commercially viable drug for the treatment of one
disease focused on the cytoskeleton, we cannot be certain that
we will also be able to develop and receive regulatory approval
for drug candidates for the treatment of other forms of that
disease or other diseases. If we or our partners fail to develop
and commercialize viable drugs, we will not achieve commercial
success.
Our proprietary rights may not adequately protect our
technologies and drug candidates.
Our commercial success will depend in part on our obtaining and
maintaining patent protection and trade secret protection of our
technologies and drug candidates as well as successfully
defending these patents against third-party challenges. We will
only be able to protect our technologies and drug candidates
from unauthorized use by third parties to the extent that valid
and enforceable patents or trade secrets cover them.
Furthermore, the degree of future protection of our proprietary
rights is uncertain because legal means afford only limited
protection and may not adequately protect our rights or permit
us to gain or keep our competitive advantage.
The patent positions of life sciences companies can be highly
uncertain and involve complex legal and factual questions for
which important legal principles remain unresolved. No
consistent policy regarding the breadth of claims allowed in
such companies patents has emerged to date in the U.S. The
patent situation outside the U.S. is even more uncertain.
Changes in either the patent laws or in interpretations of
patent laws in the U.S. or other countries may diminish the
value of our intellectual property. Accordingly, we cannot
predict the breadth of claims that may be allowed or enforced in
our patents or in third-party patents. For example:
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we or our licensors might not have been the first to make the
inventions covered by each of our pending patent applications
and issued patents; |
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we or our licensors might not have been the first to file patent
applications for these inventions; |
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others may independently develop similar or alternative
technologies or duplicate any of our technologies; |
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it is possible that none of our pending patent applications or
the pending patent applications of our licensors will result in
issued patents; |
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our issued patents and issued patents of our licensors may not
provide a basis for commercially viable drugs, or may not
provide us with any competitive advantages, or may be challenged
and invalidated by third parties; |
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we may not develop additional proprietary technologies or drug
candidates that are patentable; or |
We also rely on trade secrets to protect our technology,
especially where we believe patent protection is not appropriate
or obtainable. However, trade secrets are difficult to protect.
While we use reasonable efforts to protect our trade secrets,
our or our strategic partners employees, consultants,
contractors or scientific and other advisors may unintentionally
or willfully disclose our information to competitors. If we were
to enforce a claim that a third party had illegally obtained and
was using our trade secrets, our enforcement efforts would be
expensive and time consuming, and the outcome would be
unpredictable. In addition, courts outside the U.S. are
sometimes less willing to protect trade secrets. Moreover, if
our competitors independently develop equivalent knowledge,
methods and know-how, it will be more difficult for us to
enforce our rights and our business could be harmed.
If we are not able to defend the patent or trade secret
protection position of our technologies and drug candidates,
then we will not be able to exclude competitors from developing
or marketing competing drugs, and we may not generate enough
revenue from product sales to justify the cost of development of
our drugs and to achieve or maintain profitability.
If we are sued for infringing intellectual property rights of
third parties, such litigation will be costly and time
consuming, and an unfavorable outcome would have a significant
adverse effect on our business.
Our ability to commercialize drugs depends on our ability to
sell such drugs without infringing the patents or other
proprietary rights of third parties. Numerous U.S. and foreign
issued patents and pending patent applications, which are owned
by third parties, exist in the areas that we are exploring. In
addition, because patent applications can take several years to
issue, there may be currently pending applications, unknown to
us, which may later result in issued patents that our drug
candidates may infringe. There could also be existing patents of
which we are not aware that our drug candidates may
inadvertently infringe.
In particular, we are aware of an issued U.S. patent and at
least one pending U.S. patent application assigned to
Curis, Inc. relating to certain compounds in the quinazolinone
class. Ispinesib falls into this class of compounds. The Curis
patent claims a method of use for inhibiting signaling by what
is called the hedgehog pathway using certain such compounds.
Curis has pending applications in Europe, Japan, Australia and
Canada with claims covering compositions of certain
quinazolinone compounds. We are also aware that the Australian
application and one of the European applications have been
granted. In addition, in Europe, Australia and elsewhere, the
grant of a patent may be opposed by one or more parties. Curis
or a third party may assert that the sale of ispinesib may
infringe one or more of these or other patents. We believe that
we have valid defenses against the Curis patents if asserted
against us. However, we cannot guarantee that a court would find
such defenses valid or that such oppositions would be
successful. We have not attempted to obtain a license to this
patent. If we decide to obtain a license to this patent, we
cannot guarantee that we would be able to obtain such a license
on commercially reasonable terms, or at all.
7
In addition, we are aware of various issued U.S. patents
and pending U.S. and foreign patent applications assigned to
Cellomics, Inc. relating to an automated method for analyzing
cells. One of these applications was granted in Europe.
Cellomics or a third party may assert that our Cytometrix
technologies fall within the scope of, and thus infringe, one or
more of these patents. We have received a letter from Cellomics
notifying us that Cellomics believes we may be practicing one or
more of their patents and that Cellomics offers a use license
for such patents through its licensing program. We believe that
we have valid defenses to such an assertion. Moreover, the grant
of the European patent may be opposed by one or more parties.
However, we cannot guarantee that a court would find such
defenses valid or that such opposition would be successful. If
we decide to obtain a license to these patents, we cannot
guarantee that we would be able to obtain such a license on
commercially reasonable terms, or at all.
Other future products of ours may be impacted by patents of
companies engaged in competitive programs with significantly
greater resources (such as Merck & Co., Inc., or
Merck). Further development of these products could be impacted
by these patents and result in the expenditure of significant
legal fees.
If a third party claims that we infringe on their patents or
other proprietary rights, we could face a number of issues that
could seriously harm our competitive position, including, but
not limited to:
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infringement and other intellectual property claims that, with
or without merit, can be costly and time consuming to litigate
and can delay the regulatory approval process and divert
managements attention from our core business strategy; |
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substantial damages for past infringement which we may have to
pay if a court determines that our drugs or technologies
infringe upon a competitors patent or other proprietary
rights; |
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a court prohibiting us from selling or licensing our drugs or
technologies unless the holder licenses the patent or other
proprietary rights to us, which it is not required to
do; and |
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if a license is available from a holder, we may have to pay
substantial royalties or grant cross licenses to our patents or
other proprietary rights. |
We may become involved in disputes with our strategic
partners over intellectual property ownership, and publications
by our research collaborators and scientific advisors could
impair our ability to obtain patent protection or protect our
proprietary information, which, in either case, would have a
significant impact on our business.
Inventions discovered under our strategic alliance agreements
become jointly owned by our strategic partners and us in some
cases, and the exclusive property of one of us in other cases.
Under some circumstances, it may be difficult to determine who
owns a particular invention, or whether it is jointly owned, and
disputes could arise regarding ownership of those inventions.
These disputes could be costly and time consuming, and an
unfavorable outcome would have a significant adverse effect on
our business if we were not able to protect or license rights to
these inventions. In addition, our research collaborators and
scientific advisors have contractual rights to publish our data
and other proprietary information, subject to our prior review.
Publications by our research collaborators and scientific
advisors containing such information, either with our permission
or in contravention of the terms of their agreements with us,
may impair our ability to obtain patent protection or protect
our proprietary information, which could significantly harm our
business.
To the extent we elect to fund the development of a drug
candidate or the commercialization of a drug at our expense, we
will need substantial additional funding.
The discovery, development and commercialization of novel small
molecule drugs focused on the cytoskeleton for the treatment of
a wide array of diseases is costly. As a result, to the extent we
8
elect to fund the development of a drug candidate or the
commercialization of a drug at our expense, we will need to
raise additional capital to:
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expand our research and development and technologies; |
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fund clinical trials and seek regulatory approvals; |
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build or access manufacturing and commercialization capabilities; |
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implement additional internal systems and infrastructure; |
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maintain, defend and expand the scope of our intellectual
property; and |
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hire and support additional management and scientific personnel. |
Our future funding requirements will depend on many factors,
including, but not limited to:
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the rate of progress and cost of our clinical trials and other
research and development activities; |
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the costs and timing of seeking and obtaining regulatory
approvals; |
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the costs associated with establishing manufacturing and
commercialization capabilities; |
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the costs of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights; |
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the costs of acquiring or investing in businesses, products and
technologies; |
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the effect of competing technological and market
developments; and |
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the payment and other terms and timing of any strategic
alliance, licensing or other arrangements that we may establish. |
Until we can generate a sufficient amount of product revenue to
finance our cash requirements, which we may never do, we expect
to finance future cash needs primarily through public or private
equity offerings, debt financings or strategic alliances. We
cannot be certain that additional funding will be available on
acceptable terms, or at all. If we are not able to secure
additional funding when needed, we may have to delay, reduce the
scope of or eliminate one or more of our clinical trials or
research and development programs or future commercialization
initiatives.
We have no capacity to carry out our own clinical trials in
connection with the development of our drug candidates and
potential drug candidates, and to the extent we elect to develop
a drug candidate without a strategic partner we will need to
develop such capacity, and we will require additional
funding.
The development of drug candidates is complicated, and requires
resources and experience that we do not have. Currently, we rely
on our strategic partners to carry out these activities for
those of our drug candidates that are in clinical trials.
However, we do not have a partner for our potential cardiac
myosin activator drug candidate, or, in the event GSK elects to
terminate its development efforts, an alternative partner for
our cancer drug candidates. To the extent we decide to initiate
clinical trials for a drug candidate without support from a
strategic partner, such as a potential drug candidate from our
cardiovascular disease program, we will need to develop the
skills, technical expertise and resources necessary to carry out
such development efforts on our own or through the use of other
third parties, such as contract research organizations, or CROs.
If we utilize CROs, we will not have control over many aspects
of their activities, and will not be able to control the amount
or timing of resources that they devote to our programs. These
third parties also may not assign as high a priority to our
programs or pursue them as diligently as we would if we were
undertaking such programs ourselves, and therefore may not
complete their respective activities on schedule. CROs may also
have relationships with our competitors and
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potential competitors, and may prioritize those relationships
ahead of their relationships with us. Typically, we would have
to qualify more than one vendor for each function performed
outside of our control, which could be time consuming and
costly. The failure of CROs to carry out development efforts on
our behalf according to our requirements and FDA or other
regulatory agencies standards, or our failure to properly
coordinate and manage such efforts, could increase the cost of
our operations and delay or prevent the development, approval
and commercialization of our drug candidates.
If we fail to develop the skills, technical expertise and
resources necessary to carry out the development of our drug
candidates, or if we fail to effectively manage our CROs
carrying out such development, the commercialization of our drug
candidates will be delayed or prevented.
We currently have no marketing or sales staff, and if we are
unable to enter into or maintain strategic alliances with
marketing partners or if we are unable to develop our own sales
and marketing capabilities, we may not be successful in
commercializing our potential drugs.
We currently have no sales, marketing or distribution
capabilities. To commercialize our drugs that we determine not
to market on our own, we will depend on strategic alliances with
third parties, such as GSK, which have established distribution
systems and direct sales forces. If we are unable to enter into
such arrangements on acceptable terms, we may not be able to
successfully commercialize such drugs.
We plan to commercialize drugs on our own, with or without a
partner, that can be effectively marketed and sold in
concentrated markets that do not require a large sales force to
be competitive. To achieve this goal, we will need to establish
our own specialized sales force and marketing organization with
technical expertise and with supporting distribution
capabilities. Developing such an organization is expensive and
time consuming and could delay a product launch. In addition, we
may not be able to develop this capacity efficiently, or at all,
which could make us unable to commercialize our drugs.
To the extent that we are not successful in commercializing any
drugs ourselves or through a strategic alliance, our product
revenues will suffer, we will incur significant additional
losses and the price of our common stock and other securities,
if any, will be negatively affected.
We have no manufacturing capacity, depend on a single
contract manufacturer to produce our clinical trial drug
supplies, and anticipate continued reliance on contract
manufacturers for the development and commercialization of our
potential drugs.
We do not currently operate manufacturing facilities for
clinical or commercial production of our drug candidates under
development. We have no experience in drug formulation or
manufacturing, and we lack the resources and the capabilities to
manufacture any of our drug candidates on a clinical or
commercial scale. As a result, we currently rely on a single
contract manufacturer to supply, store and distribute drug
supplies for our clinical trials and anticipate future reliance
on a limited number of contract manufacturers until we are able
to expand our operations to include manufacturing capacities.
Any performance failure on the part of our existing or future
contract manufacturers could delay clinical development or
regulatory approval of our drug candidates or commercialization
of our drugs, producing additional losses and depriving us of
potential product revenues.
Our drug candidates require precise, high quality manufacturing.
Our failure or our contract manufacturers failure to
achieve and maintain high manufacturing standards, including the
incidence of manufacturing errors, could result in patient
injury or death, product recalls or withdrawals, delays or
failures in product testing or delivery, cost overruns or other
problems that could seriously hurt our business. Contract drug
manufacturers often encounter difficulties involving production
yields, quality control and quality assurance, as well as
shortages of qualified personnel. These manufacturers are
subject to ongoing periodic unannounced inspection by the FDA,
the U.S. Drug Enforcement Agency
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and other regulatory agencies to ensure strict compliance with
current good manufacturing practices and other applicable
government regulations and corresponding foreign standards;
however, we do not have control over contract
manufacturers compliance with these regulations and
standards. If one of our contract manufacturers fails to
maintain compliance, the production of our drug candidates could
be interrupted, resulting in delays, additional costs and
potentially lost revenues. Additionally, our contract
manufacturer must pass a preapproval inspection before we can
obtain marketing approval for any of our drug candidates in
development.
If the FDA or other regulatory agencies approve any of our drug
candidates for commercial sale, we will need to manufacture them
in larger quantities. To date, our drug candidates have been
manufactured in small quantities for preclinical testing and
clinical trials and we may not be able to successfully increase
the manufacturing capacity, whether in collaboration with
contract manufacturers or on our own, for any of our drug
candidates in a timely or economic manner, or at all.
Significant scale-up of
manufacturing may require additional validation studies, which
the FDA must review and approve. If we are unable to
successfully increase the manufacturing capacity for a drug
candidate, the regulatory approval or commercial launch of any
related drugs may be delayed or there may be a shortage in
supply. Even if any contract manufacturer makes improvements in
the manufacturing process for our drug candidates, we may not
own, or may have to share, the intellectual property rights to
such improvements.
In addition, our existing and future contract manufacturers may
not perform as agreed or may not remain in the contract
manufacturing business for the time required to successfully
produce, store and distribute our drug candidates. We currently
rely on a single contract manufacturer as the sole supply source
for our drug candidates. In the event of a natural disaster,
business failure, strike or other difficulty, we may be unable
to replace such contract manufacturer in a timely manner and the
production of our drug candidates would be interrupted,
resulting in delays and additional costs.
Switching manufacturers may be difficult because the number of
potential manufacturers is limited and the FDA must approve any
replacement manufacturer prior to manufacturing our drug
candidates. Such approval would require new testing and
compliance inspections. In addition, a new manufacturer would
have to be educated in, or develop substantially equivalent
processes for, production of our drug candidates after receipt
of FDA approval. It may be difficult or impossible for us to
find a replacement manufacturer on acceptable terms quickly, or
at all.
We expect to expand our development, clinical research and
marketing capabilities, and as a result, we may encounter
difficulties in managing our growth, which could disrupt our
operations.
We expect to have significant growth in expenditures, the number
of our employees and the scope of our operations, in particular
with respect to those drug candidates that we elect to develop
or commercialize independently or together with a partner. To
manage our anticipated future growth, we must continue to
implement and improve our managerial, operational and financial
systems, expand our facilities and continue to recruit and train
additional qualified personnel. Due to our limited resources, we
may not be able to effectively manage the expansion of our
operations or recruit and train additional qualified personnel.
The physical expansion of our operations may lead to significant
costs and may divert our management and business development
resources. Any inability to manage growth could delay the
execution of our business plans or disrupt our operations.
The failure to attract and retain skilled personnel could
impair our drug development and commercialization efforts.
Our performance is substantially dependent on the performance of
our senior management and key scientific and technical
personnel, particularly James H. Sabry, M.D., Ph.D.,
our President and Chief Executive Officer, Robert I. Blum, our
Executive Vice President, Corporate Development and Commercial
Operations and Chief Business Officer, Andrew A.
Wolff, M.D., F.A.C.C., our Senior
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Vice President, Clinical Research and Chief Medical Officer, and
Sharon A. Surrey-Barbari, our Senior Vice President, Finance and
Chief Financial Officer. The employment of these individuals and
our other personnel is terminable at will with short or no
notice. We carry key person life insurance on James H.
Sabry, M.D., Ph.D. The loss of the services of any
member of our senior management, scientific or technical staff
may significantly delay or prevent the achievement of drug
development and other business objectives by diverting
managements attention to transition matters and
identification of suitable replacements, and could have a
material adverse effect on our business, operating results and
financial condition. We also rely on consultants and advisors to
assist us in formulating our research and development strategy.
All of our consultants and advisors are either self-employed or
employed by other organizations, and they may have conflicts of
interest or other commitments, such as consulting or advisory
contracts with other organizations, that may affect their
ability to contribute to us.
In addition, we believe that we will need to recruit additional
executive management and scientific and technical personnel.
There is currently intense competition for skilled executives
and employees with relevant scientific and technical expertise,
and this competition is likely to continue. Our inability to
attract and retain sufficient scientific, technical and
managerial personnel could limit or delay our product
development efforts, which would adversely affect the
development of our drug candidates and commercialization of our
potential drugs and growth of our business.
Risks Related to Our Industry
Our competitors may develop drugs that are less expensive,
safer, or more effective, which may diminish or eliminate the
commercial success of any drugs that we may commercialize.
We compete with companies that are also developing drug
candidates that focus on the cytoskeleton, as well as companies
that have developed drugs or are developing alternative drug
candidates for cancer and cardiovascular, infectious and other
diseases. For example, with respect to cancer, Bristol-Myers
Squibbs
Taxol®
(paclitexel), Sanofi Aventis Pharmaceuticals Inc.s
Taxotere®
(docetexel), and generic equivalents of Taxol are currently
available on the market and commonly used in cancer treatment.
Furthermore, we are aware that Merck, Chiron Corp.,
Bristol-Myers Squibb and other pharmaceutical and
biopharmaceutical companies are conducting research focused on
KSP and other mitotic kinesins. In addition, Bristol-Myers
Squibb, Merck, Novartis and other pharmaceutical and
biopharmaceutical companies are developing other approaches to
inhibiting mitosis. With respect to congestive heart failure, we
are aware of a potentially competitive approach being developed
by Orion in collaboration with Abbott Laboratories.
Our competitors may:
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develop drug candidates and market drugs that are less expensive
or more effective than our future drugs; |
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commercialize competing drugs before we or our partners can
launch any drugs developed from our drug candidates; |
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obtain proprietary rights that could prevent us from
commercializing our products; |
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initiate or withstand substantial price competition more
successfully than we can; |
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have greater success in recruiting skilled scientific workers
from the limited pool of available talent; |
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more effectively negotiate third-party licenses and strategic
alliances; |
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take advantage of acquisition or other opportunities more
readily than we can; |
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develop drug candidates and market drugs that increase the
levels of efficacy or alter other drug candidate profile aspects
that our drug candidates need to show in order to obtain
regulatory approval; and |
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introduce therapies or market drugs that render the market
opportunity for our potential drugs obsolete. |
We will compete for market share against large pharmaceutical
and biotechnology companies and smaller companies that are
collaborating with larger pharmaceutical companies, new
companies, academic institutions, government agencies and other
public and private research organizations. Many of these
competitors, either alone or together with their partners, may
develop new drug candidates that will compete with ours, as
these competitors may, and in certain cases do, operate larger
research and development programs or have substantially greater
financial resources than we do. Our competitors may also have
significantly greater experience in:
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developing drug candidates; |
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undertaking preclinical testing and clinical trials; |
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building relationships with key customers and opinion-leading
physicians; |
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obtaining and maintaining FDA and other regulatory approvals of
drug candidates; |
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formulating and manufacturing drugs; and |
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launching, marketing and selling drugs. |
If our competitors market drugs that are less expensive, safer
or more effective than our potential drugs, or that reach the
market sooner than our potential drugs, we may not achieve
commercial success. In addition, the life sciences industry is
characterized by rapid technological change. Because our
research approach integrates many technologies, it may be
difficult for us to stay abreast of the rapid changes in each
technology. If we fail to stay at the forefront of technological
change we may be unable to compete effectively. Our competitors
may render our technologies obsolete by advances in existing
technological approaches or the development of new or different
approaches, potentially eliminating the advantages in our drug
discovery process that we believe we derive from our research
approach and proprietary technologies.
The regulatory approval process is expensive, time consuming
and uncertain and may prevent our partners or us from obtaining
approvals for the commercialization of some or all of our drug
candidates.
The research, testing, manufacturing, selling and marketing of
drug candidates are subject to extensive regulation by the FDA
and other regulatory authorities in the United States and other
countries, which regulations differ from country to country.
Neither we nor our partners are permitted to market our
potential drugs in the U.S. until we receive approval of a new
drug application, or NDA, from the FDA. Neither we nor our
partners have received marketing approval for any of our drug
candidates. Obtaining an NDA can be a lengthy, expensive and
uncertain process. In addition, failure to comply with the FDA
and other applicable foreign and U.S. regulatory requirements
may subject us to administrative or judicially imposed
sanctions. These include warning letters, civil and criminal
penalties, injunctions, product seizure or detention, product
recalls, total or partial suspension of production, and refusal
to approve pending NDAs, or supplements to approved NDAs.
Regulatory approval of an NDA or NDA supplement is never
guaranteed, and the approval process typically takes several
years and is extremely expensive. The FDA also has substantial
discretion in the drug approval process. Despite the time and
expense exerted, failure can occur at any stage, and we could
encounter problems that cause us to abandon clinical trials or
to repeat or perform additional preclinical testing and clinical
trials. The number and focus of preclinical studies and clinical
trials that will be required for FDA approval varies depending
on the drug candidate, the
13
disease or condition that the drug candidate is designed to
address, and the regulations applicable to any particular drug
candidate. The FDA can delay, limit or deny approval of a drug
candidate for many reasons, including:
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a drug candidate may not be safe or effective; |
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FDA officials may not find the data from preclinical testing and
clinical trials sufficient; |
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the FDA might not approve our or our contract
manufacturers processes or facilities; or |
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the FDA may change its approval policies or adopt new
regulations. |
If we or our partners receive regulatory approval for our drug
candidates, we will also be subject to ongoing FDA obligations
and continued regulatory review, such as continued safety
reporting requirements, and we may also be subject to additional
FDA post-marketing obligations, all of which may result in
significant expense and limit our ability to commercialize our
potential drugs.
Any regulatory approvals that we or our partners receive for our
drug candidates may also be subject to limitations on the
indicated uses for which the drug may be marketed or contain
requirements for potentially costly post-marketing
follow-up studies. In
addition, if the FDA approves any of our drug candidates, the
labeling, packaging, adverse event reporting, storage,
advertising, promotion and record-keeping for the drug will be
subject to extensive regulatory requirements. The subsequent
discovery of previously unknown problems with the drug,
including adverse events of unanticipated severity or frequency,
may result in restrictions on the marketing of the drug, and
could include withdrawal of the drug from the market.
The FDAs policies may change and additional government
regulations may be enacted that could prevent or delay
regulatory approval of our drug candidates. We cannot predict
the likelihood, nature or extent of adverse government
regulation that may arise from future legislation or
administrative action, either in the United States or abroad. If
we are not able to maintain regulatory compliance, we might not
be permitted to market our drugs and our business could suffer.
If physicians and patients do not accept our drugs, we may be
unable to generate significant revenue, if any.
Even if our drug candidates obtain regulatory approval,
resulting drugs, if any, may not gain market acceptance among
physicians, healthcare payors, patients and the medical
community. Even if the clinical safety and efficacy of drugs
developed from our drug candidates are established for purposes
of approval, physicians may elect not to recommend these drugs
for a variety of reasons including, but not limited to:
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timing of market introduction of competitive drugs; |
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clinical safety and efficacy of alternative drugs or treatments; |
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cost-effectiveness; |
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availability of reimbursement from health maintenance
organizations and other third-party payors; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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other potential disadvantages relative to alternative treatment
methods; and |
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insufficient marketing and distribution support. |
If our drugs fail to achieve market acceptance, we may not be
able to generate significant revenue and our business would
suffer.
14
The coverage and reimbursement status of newly approved drugs
is uncertain and failure to obtain adequate coverage and
reimbursement could limit our ability to market any drugs we may
develop and decrease our ability to generate revenue.
There is significant uncertainty related to the coverage and
reimbursement of newly approved drugs. The commercial success of
our potential drugs in both domestic and international markets
is substantially dependent on whether third-party coverage and
reimbursement is available for the ordering of our potential
drugs by the medical profession for use by their patients.
Medicare, Medicaid, health maintenance organizations and other
third-party payors are increasingly attempting to contain
healthcare costs by limiting both coverage and the level of
reimbursement of new drugs, and, as a result, they may not cover
or provide adequate payment for our potential drugs. They may
not view our potential drugs as cost-effective and reimbursement
may not be available to consumers or may not be sufficient to
allow our potential drugs to be marketed on a competitive basis.
Likewise, legislative or regulatory efforts to control or reduce
healthcare costs or reform government healthcare programs could
result in lower prices or rejection of coverage for our
potential drugs. Changes in coverage and reimbursement policies
or healthcare cost containment initiatives that limit or
restrict reimbursement for our drugs may cause our revenue to
decline.
We may be subject to costly product liability claims and may
not be able to obtain adequate insurance.
Because we conduct clinical trials in humans, we face the risk
that the use of our drug candidates will result in adverse
effects. We currently maintain product liability insurance in
the amount of $10.0 million with a $5,000 deductible per
occurrence, however, such liability insurance currently excludes
coverage of liability resulting from clinical trials. We cannot
predict the possible harms or side effects that may result from
our clinical trials. We may not have sufficient resources to pay
for any liabilities resulting from a claim excluded from, or
beyond the limit of, our insurance coverage.
In addition, once we have commercially launched drugs based on
our drug candidates, we will face exposure to product liability
claims. This risk exists even with respect to those drugs that
are approved for commercial sale by the FDA and manufactured in
facilities licensed and regulated by the FDA. We intend to
secure limited product liability insurance coverage, but may not
be able to obtain such insurance on acceptable terms with
adequate coverage, or at reasonable costs. There is also a risk
that third parties that we have agreed to indemnify could incur
liability. Even if we were ultimately successful in product
liability litigation, the litigation would consume substantial
amounts of our financial and managerial resources and may create
adverse publicity, all of which would impair our ability to
generate sales of the affected product as well as our other
potential drugs. Moreover, product recalls may be issued at our
discretion or at the direction of the FDA, other governmental
agencies or other companies having regulatory control for drug
sales. If product recalls occur, such recalls are generally
expensive and often have an adverse effect on the image of the
drugs being recalled as well as the reputation of the
drugs developer or manufacturer.
We may be subject to damages resulting from claims that our
employees or we have wrongfully used or disclosed alleged trade
secrets of their former employers.
Many of our employees were previously employed at universities
or other biotechnology or pharmaceutical companies, including
our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims
that these employees or we have inadvertently or otherwise used
or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend
against these claims. If we fail in defending such claims, in
addition to paying monetary damages, we may lose valuable
intellectual property rights or personnel. A loss of key
research personnel or their work product could hamper or prevent
our ability to commercialize certain potential drugs, which
could severely harm our business. Even if
15
we are successful in defending against these claims, litigation
could result in substantial costs and be a distraction to
management.
We use hazardous chemicals and radioactive and biological
materials in our business. Any claims relating to improper
handling, storage or disposal of these materials could be time
consuming and costly.
Our research and development processes involve the controlled
use of hazardous materials, including chemicals and radioactive
and biological materials. Our operations produce hazardous waste
products. We cannot eliminate the risk of accidental
contamination or discharge and any resultant injury from those
materials. Federal, state and local laws and regulations govern
the use, manufacture, storage, handling and disposal of
hazardous materials. We may be sued for any injury or
contamination that results from our use or the use by third
parties of these materials. Compliance with environmental laws
and regulations may be expensive, and current or future
environmental regulations may impair our research, development
and production efforts.
In addition, our partners may use hazardous materials in
connection with our strategic alliances. To our knowledge, their
work is performed in accordance with applicable biosafety
regulations. In the event of a lawsuit or investigation,
however, we could be held responsible for any injury caused to
persons or property by exposure to, or release of, these
hazardous materials used by these parties. Further, we may be
required to indemnify our partners against all damages and other
liabilities arising out of our development activities or drugs
produced in connection with these strategic alliances.
Our facilities in California are located near an earthquake
fault, and an earthquake or other types of natural disasters or
resource shortages could disrupt our operations and adversely
affect results.
Important documents and records, such as hard copies of our
laboratory books and records for our drug candidates and
compounds, are located in our corporate headquarters at a single
location in South San Francisco, California near active
earthquake zones. In the event of a natural disaster, such as an
earthquake, drought or flood, or localized extended outages of
critical utilities or transportation systems, we do not have a
formal business continuity or disaster recovery plan, and could
therefore experience a significant business interruption. In
addition, California from time to time has experienced shortages
of water, electric power and natural gas. Future shortages and
conservation measures could disrupt our operations and cause
expense, thus adversely affecting our business and financial
results.
Risks Related To an Investment in Our Securities
We expect that our stock price will fluctuate significantly,
and you may not be able to resell your shares at or above your
investment price.
The stock market, particularly in recent years, has experienced
significant volatility particularly with respect to
pharmaceutical, biotechnology and other life sciences company
stocks. The volatility of pharmaceutical, biotechnology and
other life sciences company stocks often does not relate to the
operating performance of the companies represented by the stock.
Factors that could cause this volatility in the market price of
our common stock include, but are not limited to:
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results from, and any delays in, the clinical trials programs
for our drug candidates for the treatment of cancer, including
the clinical trials for ispinesib and
SB-743921, and
including delays resulting from slower than expected patient
enrollment in such clinical trials; |
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delays in or discontinuation of the development of any of our
drug candidates by GSK; |
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failure or delays in entering additional drug candidates into
clinical trials, including a potential drug candidate for the
treatment of congestive heart failure; |
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failure or discontinuation of any of our research programs; |
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delays or other developments in establishing new strategic
alliances; |
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announcements concerning our strategic alliances with GSK or
AstraZeneca or future strategic alliances; |
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issuance of new or changed securities analysts reports or
recommendations; |
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market conditions in the pharmaceutical and biotechnology
sectors; |
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actual or anticipated fluctuations in our quarterly financial
and operating results; |
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developments or disputes concerning our intellectual property or
other proprietary rights; |
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introduction of technological innovations or new commercial
products by us or our competitors; |
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issues in manufacturing our drug candidates or drugs; |
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market acceptance of our drugs; |
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third-party healthcare reimbursement policies; |
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FDA or other U.S. or foreign regulatory actions affecting us or
our industry; |
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litigation or public concern about the safety of our drug
candidates or drugs; |
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additions or departures of key personnel; and |
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volatility in the stock prices of other companies in our
industry. |
These and other external factors may cause the market price and
demand for our common stock to fluctuate substantially, which
may limit or prevent investors from readily selling their shares
of common stock and may otherwise negatively affect the
liquidity of our common stock has been. In addition, when the
market price of a stock has been volatile, holders of that stock
have instituted securities class action litigation against the
company that issued the stock. If any of our stockholders
brought a lawsuit against us, we could incur substantial costs
defending the lawsuit. Such a lawsuit could also divert the time
and attention of our management.
If the ownership of our common stock continues to be highly
concentrated, it may prevent you and other stockholders from
influencing significant corporate decisions and may result in
conflicts of interest that could cause our stock price to
decline.
As of March 30, 2005, our executive officers, directors and
their affiliates beneficially owned or controlled approximately
39% percent of the outstanding shares of our common stock (after
giving effect to the exercise of all outstanding vested and
unvested options and warrants). Accordingly, these executive
officers, directors and their affiliates, acting as a group,
will have substantial influence over the outcome of corporate
actions requiring stockholder approval, including the election
of directors, any merger, consolidation or sale of all or
substantially all of our assets or any other significant
corporate transactions. These stockholders may also delay or
prevent a change of control of us, even if such a change of
control would benefit our other stockholders. The significant
concentration of stock ownership may adversely affect the
trading price of our common stock due to investors
perception that conflicts of interest may exist or arise.
Future sales of common stock by our existing stockholders may
cause our stock price to fall.
The market price of our common stock could decline as a result
of sales by our existing stockholders of shares of common stock
in the market after our initial public offering, or the
17
perception that these sales could occur. These sales might also
make it more difficult for us to sell equity securities at a
time and price that we deem appropriate. The
lock-up agreements
delivered by our executive officers and directors, and
substantially all of our stockholders and option holders, in
connection with our initial public offering on April 29,
2004, expired on October 27, 2004. Subject to applicable
securities law restrictions and other agreements between the
company and certain of such stockholders, these shares are now
freely tradable.
Evolving regulation of corporate governance and public
disclosure may result in additional expenses and continuing
uncertainty.
Changing laws, regulations and standards relating to corporate
governance and public disclosure, including the Sarbanes-Oxley
Act of 2002, new Securities and Exchange Commission regulations
and Nasdaq National Market rules are creating uncertainty for
public companies. We are presently evaluating and monitoring
developments with respect to new and proposed rules and cannot
predict or estimate the amount of the additional costs we may
incur or the timing of such costs. For example, compliance with
the internal control requirements of Sarbanes-Oxley
Section 404 for the year ended December 31, 2005
requires the commitment of significant resources to document and
test the adequacy of our internal controls. While we plan to
expend significant resources in developing the required
documentation and testing procedures required by
Section 404, we can provide no assurance as to conclusions
of management or by our independent registered accounting firm
with respect to the effectiveness of our internal control over
financial reporting. These new or changed laws, regulations and
standards are subject to varying interpretations, in many cases
due to their lack of specificity, and, as a result, their
application in practice may evolve over time as new guidance is
provided by regulatory and governing bodies. This could result
in continuing uncertainty regarding compliance matters and
higher costs necessitated by ongoing revisions to disclosure and
governance practices. We are committed to maintaining high
standards of corporate governance and public disclosure. As a
result, we intend to invest resources to comply with evolving
laws, regulations and standards, and this investment may result
in increased general and administrative expenses and a diversion
of management time and attention from revenue-generating
activities to compliance activities. If our efforts to comply
with new or changed laws, regulations and standards differ from
the activities intended by regulatory or governing bodies, due
to ambiguities related to practice or otherwise, regulatory
authorities may initiate legal proceedings against us and we may
be harmed.
Volatility in the stock prices of other companies may
contribute to volatility in our stock price.
The stock market in general, Nasdaq and the market for
technology companies in particular, have experienced significant
price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of those
companies. Further, there has been particular volatility in the
market prices of securities of early stage and development stage
life sciences companies. These broad market and industry factors
may seriously harm the market price of our common stock,
regardless of our operating performance.
In the past, following periods of volatility in the market price
of a companys securities, securities class action
litigation has often been instituted. A securities class action
suit against us could result in substantial costs, potential
liabilities and the diversion of managements attention and
resources.
We have never paid dividends on our capital stock, and we do
not anticipate paying any cash dividends in the foreseeable
future.
We have paid no cash dividends on any of our classes of capital
stock to date and we currently intend to retain our future
earnings, if any, to fund the development and growth of our
businesses. In addition, the terms of existing or any future
debts may preclude us from paying these dividends.
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Our common stock is thinly traded and there may not be an
active, liquid trading market for our common stock.
There is no guarantee that an active trading market for our
common stock will be maintained on Nasdaq, or that the volume of
trading will be sufficient to allow for timely trades. Investors
may not be able to sell their shares quickly or at the latest
market price if trading in our stock is not active or if trading
volume is limited. In addition, if trading volume in our common
stock is limited, trades of relatively small numbers of shares
may have a disproportionate effect on the market price of our
common stock.
Risks Relating to the Offered Securities
Our stock price may continue to experience fluctuations,
which may significantly affect the market price of our common
stock and securities convertible into or exchangeable for our
common stock.
The market price of our common stock fluctuates and is expected
to continue to be volatile in the future. These price
fluctuations may be rapid and severe and may leave investors
little time to react. Factors that may affect the market price
of our common stock include the risks and uncertainties
described above in this prospectus or described in any
applicable prospectus supplement, as well as changes in
securities analysts earnings projections or
recommendations. These factors could lead to a significant
decrease in the market price of our common stock and securities
convertible into or exchangeable for our common stock.
The securities we are offering may not develop an active
public market, which could depress the resale price of the
securities.
The securities that we may offer, other than our common stock,
will be new issues of securities for which there is currently no
trading market. We cannot predict whether an active trading
market for the securities will develop or be sustained. Any
underwriters may make a market in these securities, but will not
be obligated to do so and may discontinue any market making at
any time without notice. If an active trading market were to
develop, the securities could trade at prices that may be lower
than the initial offering price of the securities. We cannot
guarantee the liquidity of the trading markets for any
securities.
We will have broad discretion over the use of the proceeds to
us from this offering and may apply it to uses that do not
improve our operating results or the value of your
securities.
We will have broad discretion to use the net proceeds to us from
this offering, and investors will be relying solely on the
judgment of our board of directors and management regarding the
application of these proceeds. Although we expect to use the net
proceeds from this offering for general corporate purposes, we
have not allocated these net proceeds for specific purposes.
Investors will not have the opportunity, as part of their
investment decision, to assess whether the proceeds are being
used appropriately. Our use of the proceeds may not improve our
operating results or increase the value of the securities being
offered hereby.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
In addition to the other information contained or incorporated
by reference in this prospectus, you should carefully consider
the risk factors disclosed in this prospectus or any prospectus
supplement when evaluating an investment in our securities. This
prospectus contains forward-looking statements that are based
upon current expectations that are within the meaning of the
Private Securities Reform Act of 1995. It is the Companys
intent that such statements be protected by the safe harbor
created thereby.
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Forward-looking statements involve risks and uncertainties and
our actual results and the timing of events may differ
significantly from the results discussed in the forward-looking
statements. Examples of such forward-looking statements include,
but are not limited to, statements regarding:
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the potential benefits of our drug candidates and potential drug
candidates; |
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the utility of our proprietary technologies and biological focus; |
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our plans or ability to commercialize drugs, with or without a
partner; |
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increasing expenditures and losses; |
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expansion of the scope and size of research and development
efforts; |
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potential competitors; |
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our needs for additional financing; |
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expected future sources of revenue and capital; |
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protection of our intellectual property; and |
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increasing the number of our employees and recruiting additional
key personnel. |
USE OF PROCEEDS
Unless otherwise indicated in a prospectus supplement, the net
proceeds from the sale of securities offered by this prospectus
will be used for general corporate purposes and working capital
requirements. We may also use a portion of the net proceeds to
fund possible investments in and acquisitions of complementary
businesses, partnerships, minority investments, products or
technologies. Currently, there are no commitments or agreements
regarding such acquisitions or investments that are material.
Pending their ultimate use, we intend to invest the net proceeds
in money market funds, commercial paper and governmental and
non-governmental debt securities.
RATIO OF EARNINGS AVAILABLE TO COVER FIXED CHARGES
The ratio of earnings to fixed charges and the ratio of earnings
to combined fixed charges and preferred stock dividends for each
of the periods indicated is as follows:
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Ratio of earnings available to
cover fixed charges(1)
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Ratio of earnings available to
combined fixed charges and preferred dividends(1)
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(1) |
Due to our losses in years ended December 31, 2000, 2001,
2002, 2003 and 2004 and the quarter ended March 31, 2005,
the ratio coverage was less than 1:1. Additional earnings of
$13.1 million, $15.9 million, $23.1 million,
$32.7 million, $37.2 million and $10.5 million
would have been required in each of those periods, respectively,
to achieve a coverage of 1:1 |
In calculating the ratio of earnings available to cover fixed
charges and the ratio of earnings available to cover combined
fixed charges and preferred dividends, earnings
consists of net income (loss) before provisions for income taxes
plus fixed charges. Fixed charges consist of:
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interest expense; |
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amortization of prepayment penalty on debt; and |
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one-third of our rental expense, which we believe to be
representative of interest attributable to rentals. |
For the periods set forth in the table above, we had preferred
stock outstanding only during 2000, 2001, 2002, 2003 and until
April 29, 2004. All outstanding shares of preferred stock
were converted into shares of common stock in connection with
our initial public offering under our Registration Statement
(SEC File
No. 333-112261)
declared effective by the SEC on April 29, 2004. We have no
preferred stock outstanding as of the date of this prospectus.
DESCRIPTION OF CAPITAL STOCK
As of the date of this prospectus, our authorized capital stock
consists of 130,000,000 shares. Those shares consist of
120,000,000 shares designated as common stock,
$0.001 par value, and 10,000,000 shares designated as
preferred stock, $0.001 par value. The only equity
securities currently outstanding are shares of common stock. As
of May 31, 2005, there were approximately
28,615,114 shares of common stock issued and outstanding.
The following description summarizes the material terms of our
capital stock. This summary is, however, subject to the
provisions of our restated certificate of incorporation and any
applicable certificate of designations for a series of preferred
stock, and by the provisions of applicable law.
Common Stock
Holders of common stock are entitled to one vote for each share
held of record on all matters submitted to a vote of
stockholders. Upon any liquidation, dissolution or winding up of
our business, the holders of common stock are entitled to share
equally in all assets available for distribution after payment
of all liabilities and provision for liquidation preference of
shares of preferred stock then outstanding. Holders of common
stock have no preemptive rights or rights to convert their
common stock into any other securities. There are no redemption
or sinking fund provisions applicable to the common stock.
Holders of common stock are entitled to receive dividends
declared by the board of directors, out of funds legally
available for the payment of dividends, subject to the rights of
holders of preferred stock. Currently, we are not paying
dividends.
Our common stock is listed on The Nasdaq National Market under
the symbol CYTK. The transfer agent and registrar
for our common stock is Mellon Investor Services LLC.
Mellons address is 235 Montgomery Street,
San Francisco, California 94104 and its telephone number is
(415) 743-1422.
All outstanding shares of common stock are fully paid and
non-assessable, and all shares of common stock offered by this
prospectus, or issuable upon conversion or exercise of
securities, will, when issued, be validly issued and fully paid
and non-assessable.
Preferred Stock
Pursuant to our restated certificate of incorporation, our board
of directors has the authority, without further approval by the
stockholders, to designate and issue up 10,000,000 shares
of preferred stock in one or more series. Cytokinetics
board of directors may designate the powers, preferences,
privileges and relative participating, optional or special
rights and the qualifications, limitations or restrictions of
each series of preferred stock, including dividend rights,
conversion rights, voting rights, terms of redemption and
liquidation preferences, any or all of which may be greater than
the rights of the common stock. Thus, without stockholder
approval, our board of directors could authorize the issuance of
preferred stock with voting, conversion and other rights that
could dilute the voting power and other rights of holders of our
common stock, and may have the effect of decreasing the market
price of the common stock.
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The description of certain provisions of the preferred stock set
forth in any prospectus supplement does not purport to be
complete and is subject to and qualified in its entirety by
reference to our certificate of incorporation and the
certificate of designations relating to each series of preferred
stock. The applicable prospectus supplement will describe the
specific terms of any series of preferred stock being offered
which may include:
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the specific designation, number of shares, seniority and
purchase price; |
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any liquidation preference per share and any accumulated
dividends upon the liquidation, dissolution or winding up of
Cytokinetics affairs; |
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any date of maturity; |
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any redemption, repayment or sinking fund provisions; |
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any dividend rate or rates, whether dividend rate is fixed or
variable, the date dividends accrue, the dates on which any such
dividends will be payable (or the method by which such rates or
dates will be determined), and whether dividends will be
cumulative; |
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any voting rights; |
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if other than the currency of the U.S., the currency or
currencies (including composite currencies) in which such
preferred stock is denominated and in which payments will or may
be payable; |
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the method by which amounts in respect of such series of
preferred stock may be calculated and any commodities,
currencies or indices, or value, rate or price, relevant to such
calculation; |
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whether such series of preferred stock is convertible and, if
so, the securities or rights into which it is convertible, and
the terms and conditions upon which such conversions will be
effected; |
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the place or places where dividends and other payments on such
series of preferred stock will be payable; and |
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any additional voting, dividend, liquidation, redemption and
other rights, preferences, privileges, limitations and
restrictions. |
All shares of preferred stock offered by this prospectus, or
issuable upon conversion or exercise of securities, will, when
issued, be validly issued and fully paid and non-assessable.
Anti-Takeover Effects of Some Provisions of Delaware Law
Provisions of Delaware law and our amended and restated
certificate of incorporation and amended bylaws could make the
acquisition of our company through a tender offer, a proxy
contest or other means more difficult and could make the removal
of incumbent officers and directors more difficult. We expect
these provisions to discourage coercive takeover practices and
inadequate takeover bids and to encourage persons seeking to
acquire control of our company to first negotiate with our board
of directors. We believe that the benefits provided by our
ability to negotiate with the proponent of an unfriendly or
unsolicited proposal outweigh the disadvantages of discouraging
these proposals. We believe the negotiation of an unfriendly or
unsolicited proposal could result in an improvement of its terms.
We are subject to Section 203 of the Delaware General
Corporation Law, an anti-takeover law. In general,
Section 203 prohibits a publicly held Delaware corporation
from engaging in a business
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combination with an interested stockholder for
a period of three years following the date the person became an
interested stockholder, unless:
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prior to the date of the transaction, the board of directors of
the corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an
interested stockholder; |
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the stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares
outstanding (a) shares owned by persons who are directors
and also officers, and (b) shares owned by employee stock
plans in which employee participants do not have the right to
determine; |
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confidentially whether shares held subject to the plan will be
tendered in a tender or exchange offer; or |
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on or subsequent to the date of the transaction, the business
combination is approved by the board and authorized at an annual
or special meeting of stockholders, and not by written consent,
by the affirmative vote of at least 66% of the outstanding
voting stock which is not owned by the interested stockholder. |
Generally, a business combination includes a merger,
asset or stock sale, or other transaction resulting in a
financial benefit to the interested stockholder. An
interested stockholder is a person who, together
with affiliates and associates, owns or, within three years
prior to the determination of interested stockholder status, did
own 15% or more of a corporations outstanding voting
securities. We expect the existence of this provision to have an
anti-takeover effect with respect to transactions our board of
directors does not approve in advance. We also anticipate that
Section 203 may also discourage attempts that might result
in a premium over the market price for the shares of common
stock held by stockholders.
Anti-Takeover Effects of Provisions of Our Charter
Documents
Our amended and restated certificate of incorporation provides
for our board of directors to be divided into three classes
serving staggered terms. Approximately one-third of the board of
directors will be elected each year. The provision for a
classified board could prevent a party who acquires control of a
majority of the outstanding voting stock from obtaining control
of the board of directors until the second annual stockholders
meeting following the date the acquirer obtains the controlling
stock interest. The classified board provision could discourage
a potential acquirer from making a tender offer or otherwise
attempting to obtain control of our company and could increase
the likelihood that incumbent directors will retain their
positions. Our amended and restated certificate of incorporation
provides that directors may be removed with cause by the
affirmative vote of the holders of the outstanding shares of
common stock.
Our amended bylaws establish an advance notice procedure for
stockholder proposals to be brought before an annual meeting of
our stockholders, including proposed nominations of persons for
election to the board of directors. At an annual meeting,
stockholders may only consider proposals or nominations
specified in the notice of meeting or brought before the meeting
by or at the direction of the board of directors. Stockholders
may also consider a proposal or nomination by a person who was a
stockholder of record on the record date for the meeting, who is
entitled to vote at the meeting and who has given to our
Secretary timely written notice, in proper form, of his or her
intention to bring that business before the meeting. The amended
bylaws do not give the board of directors the power to approve
or disapprove stockholder nominations of candidates or proposals
regarding other business to be conducted at a special or annual
meeting of the stockholders. However, our bylaws may have the
effect of precluding the conduct of business at a meeting if the
proper procedures are not followed. These provisions may also
discourage or deter a potential
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acquirer from conducting a solicitation of proxies to elect the
acquirers own slate of directors or otherwise attempting
to obtain control of our company.
Under Delaware law, a special meeting of stockholders may be
called by the board of directors or by any other person
authorized to do so in the amended and restated certificate of
incorporation or the amended bylaws. Our amended bylaws
authorize a majority of our board of directors, the chairman of
the board or the chief executive officer to call a special
meeting of stockholders.
Because our stockholders do not have the right to call a special
meeting, a stockholder could not force stockholder consideration
of a proposal over the opposition of the board of directors by
calling a special meeting of stockholders prior to such time as
a majority of the board of directors believed or the chief
executive officer believed the matter should be considered or
until the next annual meeting provided that the requestor met
the notice requirements. The restriction on the ability of
stockholders to call a special meeting means that a proposal to
replace the board also could be delayed until the next annual
meeting.
Delaware law provides that stockholders may execute an action by
written consent in lieu of a stockholder meeting. However,
Delaware law also allows us to eliminate stockholder actions by
written consent. Elimination of written consents of stockholders
may lengthen the amount of time required to take stockholder
actions since actions by written consent are not subject to the
minimum notice requirement of a stockholders meeting.
However, we believe that the elimination of stockholders
written consents may deter hostile takeover attempts. Without
the availability of stockholders actions by written
consent, a holder controlling a majority of our capital stock
would not be able to amend our bylaws or remove directors
without holding a stockholders meeting. The holder would
have to obtain the consent of a majority of the board of
directors, the chairman of the board or the chief executive
officer to call a stockholders meeting and satisfy the
notice periods determined by the board of directors. Our amended
and restated certificate of incorporation provides for the
elimination of actions by written consent of stockholders upon
the closing of this offering.
DESCRIPTION OF THE WARRANTS
General
We may issue warrants for the purchase of our common stock or
preferred stock or any combination thereof. Warrants may be
issued independently or together with our common stock or
preferred stock and may be attached to or separate from any
offered securities. Each series of warrants will be issued under
a separate warrant agreement to be entered into between us and a
bank or trust company, as warrant agent. The warrant agent will
act solely as our agent in connection with the warrants. The
warrant agent will not have any obligation or relationship of
agency or trust for or with any holders or beneficial owners of
warrants. This summary of certain provisions of the warrants is
not complete. For the terms of a particular series of warrants,
you should refer to the prospectus supplement for that series of
warrants and the warrant agreement for that particular series.
The prospectus supplement relating to a particular series of
warrants to purchase our common stock or preferred stock will
describe the terms of the warrants, including the following:
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the title of the warrants; |
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the offering price for the warrants, if any; |
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the aggregate number of the warrants; |
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the designation and terms of the common stock or preferred stock
that may be purchased upon exercise of the warrants; |
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if applicable, the designation and terms of the securities with
which the warrants are issued and the number of warrants issued
with each security; |
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if applicable, the date from and after which the warrants and
any securities issued with the warrants will be separately
transferable; |
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the number of shares of common stock or preferred stock that may
be purchased upon exercise of a warrant and the exercise price
for the warrants; |
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the dates on which the right to exercise the warrants shall
commence and expire; |
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if applicable, the minimum or maximum amount of the warrants
that may be exercised at any one time; |
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the currency or currency units in which the offering price, if
any, and the exercise price are payable; |
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if applicable, a discussion of material U.S. federal income
tax considerations; |
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the antidilution provisions of the warrants, if any; |
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the redemption or call provisions, if any, applicable to the
warrants; |
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any provisions with respect to a holders right to require
us to repurchase the warrants upon a change in control; and |
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any additional terms of the warrants, including terms,
procedures, and limitations relating to the exchange, exercise
and settlement of the warrants. |
Holders of warrants will not be entitled:
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to vote, consent or receive dividends; |
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receive notice as stockholders with respect to any meeting of
stockholders for the election of our directors or any other
matter; or |
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exercise any rights as stockholders of Cytokinetics. |
As set forth in the applicable prospectus supplement, the
exercise price and the number of shares of common stock
purchasable upon exercise of the warrant will be subject to
adjustment in certain events, including the issuance of a stock
dividend to any holders of common stock or preferred stock, a
stock split, reverse stock split, combination, subdivision or
reclassification of common stock or preferred stock, and such
other events, if any, specified in the applicable prospectus
supplement.
PLAN OF DISTRIBUTION
We may sell the securities covered by this prospectus in any of
the following ways:
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through one or more underwriters or dealers; |
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through agents; |
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directly to one or more purchasers; or |
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through a combination of the above. |
If underwriters are used in the sale, they will acquire the
securities for their own account and may resell the securities
from time to time in one or more transactions at a fixed public
offering price. The obligations of the underwriters to purchase
the securities will be subject to the conditions set forth in
the applicable underwriting agreement. We may offer the
securities to the public through underwriting syndicates
represented by managing underwriters or by underwriters without
a syndicate. Each prospectus supplement will identify any
underwriter, dealer or agent, and describe
25
any compensation received by them from us. Any initial public
offering price and any discounts or concessions allowed or
re-allowed or paid to dealers may be changed from time to time.
Underwriters, dealers or agents may receive compensation in the
form of discounts, concessions or commissions from us or our
purchasers as their agents in connection with the sale of the
securities. These underwriters, dealers or agents may be
considered to be underwriters under the Securities Act. As a
result, discounts, commissions or profits on resale received by
underwriters, dealers or agents may be treated as underwriting
discounts and commissions.
Underwriters or agents and their associates may be customers of,
engage in transactions with or perform services for us in the
ordinary course of business. We will describe in the prospectus
supplement, naming the underwriter, the nature of any such
relationship.
We may grant underwriters who participate in the distribution of
the securities an option to purchase additional securities to
cover over-allotments, if any, in connection with the
distribution. We will identify the amount of any such
over-allotment option in the applicable prospectus supplement.
We will name any agent involved in the offering and sale of
securities and we will describe any commissions we will pay the
agent and the terms of any agency relationship in the prospectus
supplement. We may authorize agents or underwriters to solicit
offers by certain types of institutional investors to purchase
securities from us at the public offering price set forth in the
prospectus supplement pursuant to delayed delivery contracts
providing for payment and delivery on a specified date in the
future. We will describe the conditions to these contracts and
the commissions we must pay for solicitation of these contracts
in the prospectus supplement.
We may distribute the securities from time to time in one or
more transactions:
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at a fixed price or prices, which may be changed from time to
time; |
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at market prices prevailing at the time of sale; |
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at prices related to prevailing market prices; and |
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at negotiated prices. |
A prospectus supplement or supplements will describe the method
of distribution of each distribution of securities in the
applicable prospectus supplement.
We may determine the price or other terms of the securities
offered under this prospectus by use of an electronic auction.
We will describe how any auction will determine the price or any
other terms, how potential investors may participate in the
auction and the nature of the underwriters obligations in
the related supplement to this prospectus.
Underwriters, dealers and agents may be entitled to
indemnification by us against certain civil liabilities,
including liabilities under the Securities Act, or to
contribution with respect to payments made by the underwriters,
dealers or agents, under agreements between us and the
underwriters, dealers and agents.
In connection with the offering of the securities, certain
persons participating in such offering may engage in
transactions that stabilize, maintain or otherwise affect the
market price, including over-allotment, stabilizing
transactions, short covering transactions and penalty bids in
accordance with Regulation M under the Exchange Act.
Over-allotment involves sales in excess of the offering size,
which create a short position. Stabilizing transactions permit
bids to purchase the underlying security so long as the
stabilizing bids do not exceed a specified maximum. Short
covering transactions involve purchases of the common stock in
the open market after the distribution is completed to cover
short positions. Penalty bids permit the underwriters to reclaim
a selling concession from a dealer when the securities
originally sold by the dealer is purchased in a covering
transaction to cover short positions. Those activities may cause
the price of the securities to be
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higher than it would otherwise be. If commenced, the
underwriters may discontinue any of the activities at any time.
All securities we offer, other than common stock, will be new
issues of securities with no established trading market. The
securities may or may not be listed on a national securities
exchange or traded in the
over-the-counter
market. Any underwriters may make a market in these securities,
but will not be obligated to do so and may discontinue any
market making at any time without notice. We cannot guarantee
the liquidity of the trading markets for any securities.
Any underwriters who are qualified market makers on the Nasdaq
National Market may engage in passive market making transactions
in the securities on the Nasdaq National Market in accordance
with Rule 103 of Regulation M, during the business day
prior to the pricing of the offering, before the commencement of
offers or sales of the securities. Passive market makers must
comply with applicable volume and price limitations and must be
identified as passive market makers. In general, a passive
market maker must display its bid at a price not in excess of
the highest independent bid for such security; if all
independent bids are lowered below the passive market
makers bid, however, the passive market makers bid
must then be lowered when certain purchase limits are exceeded.
To the extent required, this prospectus may be amended and
supplemented from time to time to describe a specific plan of
distribution.
LEGAL MATTERS
The validity of securities offered hereby will be passed upon by
Wilson Sonsini Goodrich & Rosati, Professional
Corporation, Palo Alto, California.
EXPERTS
The financial statements incorporated in this prospectus by
reference to the Annual Report on
Form 10-K for the
year ended December 31, 2004 have been so incorporated in
reliance on the report of PricewaterhouseCoopers LLP, an
independent registered public accounting firm, given on the
authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. We have filed with the SEC a
registration statement on
Form S-3 under the
Securities Act with respect to the shares of common stock we are
offering under this prospectus. This prospectus does not contain
all of the information set forth in the registration statement
and the exhibits to the registration statement. For further
information with respect to us and the securities we are
offering under this prospectus, we refer you to the registration
statement and the exhibits and schedules filed as a part of the
registration statement. You may read and copy the registration
statement, as well as our reports, proxy statements and other
information, at the SECs public reference room at
450 Fifth Street, N.W., Washington, D.C. 20549. You
can request copies of these documents by writing to the SEC and
paying a fee for the copying cost. Please call the SEC at
1-800-SEC-0330 for more
information about the operation of the public reference rooms.
Our SEC filings are also available at the SECs web site at
http://www.sec.gov.
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INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference into
this prospectus the information we filed with the SEC. This
means that we can disclose important information by referring
you to those documents. The information incorporated by
reference is considered to be a part of this prospectus.
Information that we file later with the SEC will automatically
update and supersede this information. We incorporate by
reference the documents listed below and any future filings made
by us with the SEC under Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act (other than reports or portions furnished
under Items 2.02, 7.01 or 8.01 of
Form 8-K) until we
complete our offering of the securities offered by this
prospectus:
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our annual report on
Form 10-K for the
fiscal year ended December 31, 2004; |
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our definitive proxy statement on Schedule 14A, filed on
April 6, 2005; |
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our quarterly report on
Form 10-Q for the
fiscal quarter ended March 31, 2005; |
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our current reports on
Form 8-K dated
January 6, 2005, February 7, 2005, March 28,
2005, March 30, 2005, and April 5, 2005; and |
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the description of our common stock contained in our
Registration Statement on
Form 8-A, filed
with the Securities and Exchange Commission on March 12,
2004, and any further amendment or report filed hereafter for
the purpose of updating any such description. |
Copies of documents incorporated by reference, excluding
exhibits except to the extent such exhibits are specifically
incorporated by reference, are available from us without charge,
upon oral or written request to:
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Cytokinetics, Incorporated |
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280 East Grand Avenue |
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South San Francisco, California 94080 |
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United States of America |
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Attn: Investor Relations |
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(650) 624-3000 |
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No
dealer, salesperson or other person is authorized to give any
information or to represent anything not contained in this
prospectus supplement or the accompanying prospectus. You must
not rely on any unauthorized information or representations.
This prospectus supplement is an offer to sell only the shares
offered hereby, but only under circumstances and in
jurisdictions where it is lawful to do so. The information
contained in this prospectus supplement and the accompanying
prospectus is current only as of its date.
TABLE OF CONTENTS
Prospectus Supplement
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S-1 |
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S-3 |
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S-22 |
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S-22 |
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S-23 |
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S-23 |
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S-23 |
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S-24 |
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Prospectus
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Risk Factors
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Disclosure Regarding
Forward-Looking Statements
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Use Of Proceeds
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Description of Capital Stock
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Description of the Warrants
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Plan of Distribution
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Legal Matters
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Experts
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Where You Can Find More Information
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Information Incorporated By
Reference
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5,000,000 Shares
Cytokinetics, Incorporated
Common Stock
January 20, 2006