e424b5
Filed pursuant to Rule 424(b)(5)
Registration No. 333-155259
PROSPECTUS SUPPLEMENT
To Prospectus dated November 19, 2008
5,300,000 Shares of Common Stock
8,070 Shares of Series A Convertible Preferred Stock
Warrants to Purchase 6,685,000 Shares of Common Stock
Cytokinetics, Incorporated
Common Stock
Series A Convertible Preferred Stock
Warrants to Purchase Shares of Common Stock
Pursuant to this prospectus supplement and the accompanying prospectus, we are offering an
aggregate of 5,300,000 shares of our common stock at a price of $1.50 per share, 8,070 shares of
our Series A Convertible Preferred Stock (Series A Preferred Stock) at a price of $1,500.00 per
share, and warrants to purchase 6,685,000 shares of our common stock with an initial exercise price
of $1.65 per share, to certain institutional investors pursuant to a securities purchase agreement,
dated April 18, 2011. This prospectus also relates to the offering of the shares of common stock
issuable upon conversion of the Series A Preferred Stock and upon exercise of the warrants. The
aggregate purchase price for the shares of common stock, Series A Preferred Stock and warrants to
purchase shares of common stock is approximately $20.1 million. We will receive net proceeds from
the sale of these shares of approximately $19.8 million after deducting our estimated offering
expenses.
Our common stock is quoted on The NASDAQ Global Market under the symbol CYTK. The last reported
sale price of our common stock on The NASDAQ Global Market on April 15, 2011, was $1.50 per share.
We are not listing our Series A Preferred Stock on an exchange or any trading system and we do not
expect that a trading market for our Series A Preferred Stock will develop.
Each share of Series A Preferred Stock is convertible into 1,000 shares of our common stock at any
time at the option of the holder, provided that the holder will be prohibited from converting
Series A Preferred Stock into shares of our common stock if, as a result of such conversion, the
holder, together with its affiliates, would own more than 9.98% of the total number of shares of
our common stock then issued and outstanding. In the event of our liquidation, dissolution, or
winding up, holders of our Series A Preferred Stock will receive a payment equal to $0.001 per
share of Series A Preferred Stock before any proceeds are distributed to the holders of our common
stock. Shares of Series A Preferred Stock will generally have no voting rights, except as required
by law and except that the consent of holders of a majority of the outstanding Series A Preferred
Stock will be required to amend the terms of the Series A Preferred Stock.
Investing in our common stock and/or our Series A Preferred Stock involves a high degree of risk.
Please read Risk Factors beginning on page S-5 of this prospectus supplement and in the
documents incorporated by reference into this prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or
disapproved of these securities or determined if this prospectus supplement or the accompanying
prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
We currently anticipate that the closing of the offering will take place on or about April 20,
2011. On the closing date, we will issue the shares of common stock, shares of Series A Preferred
Stock and warrants to purchase shares of common stock to the investors and receive funds in the
amount of the aggregate purchase price.
The date of this prospectus supplement is April 18, 2011.
TABLE OF CONTENTS
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Prospectus Supplement |
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S-1 |
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S-5 |
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S-8 |
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S-10 |
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S-11 |
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S-12 |
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S-13 |
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S-16 |
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S-16 |
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S-16 |
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S-17 |
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Prospectus |
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Cytokinetics, Incorporated |
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1 |
Risk Factors |
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2 |
Disclosure Regarding Forward-Looking Statements |
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28 |
Use of Proceeds |
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29 |
Ratio of Earnings Available to Cover Fixed Charges |
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29 |
Description of Capital Stock |
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30 |
Description of the Warrants |
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34 |
Plan of Distribution |
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36 |
Legal Matters |
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Experts |
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38 |
Where You Can Find More Information |
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Information Incorporated by Reference |
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We provide information to you about this offering of shares of our common stock and Series A
Preferred Stock in two separate documents that are bound together: (1) this prospectus supplement,
which describes the specific details regarding this offering; and (2) the accompanying prospectus,
which provides general information, some of which may not apply to this offering. Generally, when
we refer to this prospectus, we are referring to both documents combined. If information in this
prospectus supplement is inconsistent with the accompanying prospectus, you should rely on this
prospectus supplement.
You should rely only on information contained in or incorporated by reference into this prospectus
supplement and the accompanying prospectus. We have not authorized anyone to provide you with
information that is different. We are offering to sell and seeking offers to buy shares of our
common stock, shares of Series A Preferred Stock and warrants to purchase shares of our common
stock only in jurisdictions where offers and sales are permitted. The information contained in this
prospectus supplement, the accompanying prospectus and the documents incorporated by reference
herein and therein are accurate only as of their respective dates, regardless of the time of
delivery of this prospectus supplement or of any sale of our common stock, shares of Series A
Preferred Stock and warrants to purchase shares of our common stock. Our business, financial
condition, results of operations and prospects may have changed since those dates. You should read
this prospectus supplement, the accompanying prospectus, and the documents incorporated by
reference in this prospectus supplement and the accompanying prospectus in their entirety before
making an investment decision. You should also read and consider the information in the documents
we have referred you to in the sections of this prospectus supplement entitled Where You Can Find
More Information and Incorporation of Certain Information by Reference.
Unless stated
otherwise, references in this prospectus supplement and the accompanying prospectus to
Cytokinetics, we, us, or our refer to Cytokinetics, Incorporated, unless the context
requires otherwise.
S-i
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information about us, this offering and selected information
contained elsewhere in or incorporated by reference into this prospectus supplement. This summary
is not complete and does not contain all of the information that you should consider before
deciding whether to invest in our common stock, Series A Preferred Stock or warrants to purchase
shares of common stock. For a more complete understanding of our company and this offering, you
should read and consider carefully the more detailed information in this prospectus supplement and
the accompanying prospectus, including the information incorporated by reference in this prospectus
supplement and the accompanying prospectus. If you invest in our common stock, Series A Preferred
Stock or warrants to purchase shares of our common stock, you are assuming a high degree of risk.
See Risk Factors in this prospectus supplement beginning on page S-5 and in the documents
incorporated by reference into this prospectus supplement.
Cytokinetics, Incorporated
Our Business
We are a clinical-stage biopharmaceutical company focused on the discovery and development of
novel small molecule therapeutics that modulate muscle function for the potential treatment of
serious diseases and medical conditions. Our research and development activities relating to the
biology of muscle function have evolved from our knowledge and expertise regarding the
cytoskeleton, a complex biological infrastructure that plays a fundamental role within every human
cell. Our current research and development programs relating to the biology of muscle function are
directed to small molecule modulators of the contractility of cardiac, skeletal and smooth muscle.
Our cardiac muscle contractility program is focused on the cardiac sarcomere, the basic unit of
muscle contraction in the heart. Our lead drug candidate from this program, omecamtiv mecarbil
(formerly known as CK-1827452), is a novel cardiac muscle myosin activator. We have conducted a
clinical development program for omecamtiv mecarbil for the potential treatment of heart failure,
comprised of a series of Phase I and Phase IIa clinical trials. In May 2009, Amgen acquired an
exclusive license to develop and commercialize omecamtiv mecarbil worldwide, except Japan, subject
to our development and commercialization participation rights.
CK-2017357 is the lead drug candidate from our skeletal sarcomere activator program. The skeletal
muscle sarcomere is the basic unit of skeletal muscle contraction. CK-2017357 is currently the
subject of a Phase IIa clinical trials program. We believe CK-2017357 may be useful in treating
diseases or medical conditions associated with skeletal muscle weakness or wasting. CK-2017357 has
received an orphan drug designation from the FDA for the treatment of amyotrophic lateral
sclerosis (also known as ALS or Lou Gehrigs disease). We are also advancing a second,
structurally distinct, fast skeletal muscle sarcomere activator, CK-2066260, in non-clinical
studies intended to enable the filing of an investigational new drug application (IND) with the
U.S. Food and Drug Administration (FDA). Both of these compounds selectively activate the fast
skeletal muscle troponin complex, which is a set of regulatory proteins that modulates the
contractility of the fast skeletal muscle sarcomere.
In our smooth muscle contractility program, we are conducting non-clinical development of
compounds that directly inhibit smooth muscle myosin, the motor protein central to the contraction
of smooth muscle. These compounds cause the relaxation of contracted smooth muscle, and so may be
useful as potential treatments for diseases and conditions associated with excessive smooth muscle
contraction, such as bronchoconstriction associated with asthma and chronic obstructive pulmonary
disease.
Earlier research activities at the company were directed to the inhibition of mitotic kinesins, a
family of cytoskeletal motor proteins involved in the process of cell division, or mitosis. This
research produced three drug candidates that have progressed into clinical testing for the
potential treatment of cancer: ispinesib, SB-743921 and GSK-923295. Effective February 2010, our
strategic alliance with GlaxoSmithKline (GSK) relating to our mitotic kinesin inhibitors
terminated by mutual agreement. We are currently evaluating strategic alternatives for these drug
candidates with third parties.
Two of our drug candidates directed to muscle contractility have now demonstrated pharmacodynamic
activity in patients: omecamtiv mecarbil in patients with heart failure and CK-2017357 in patients
with ALS. In 2011, we expect to focus on translating the observed pharmacodynamic activity of
these compounds into potentially meaningful clinical benefits for these patients. Our potential
drug candidate CK-2066260 has demonstrated pharmacological activity in preclinical models.
S-1
Corporate Information
We were incorporated in Delaware in August 1997 as Cytokinetics, Incorporated. We conduct our
administration, finance, business development, clinical development, commercial development,
quality assurance and regulatory affairs activities primarily from our headquarters located at 280
East Grand Avenue, South San Francisco, CA. Our general telephone number at that address is (650)
624-3000 and our website is located at www.cytokinetics.com. The information on, or that can be
accessed through, our website is not incorporated by reference in this prospectus supplement, and
you should not consider it to be a part of this prospectus supplement. Our website address is
included as an inactive textual reference only.
S-2
THE OFFERING
Common Stock
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Common Stock Offered By Us
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5,300,000 shares |
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Common Stock To Be Outstanding
Immediately After This Offering
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72,216,100 shares |
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NASDAQ Global Market Listing
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Our common stock is listed on
The NASDAQ Global Select Market
under the symbol CYTK. |
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Series A Convertible Preferred Stock |
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Series A Preferred Stock Offered By Us
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8,070 shares of Series A
Preferred Stock will be
offered in this offering.
This prospectus also
relates to the offering of
the shares of common stock
issuable upon conversion of
the Series A Preferred
Stock. |
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Conversion
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Each share of our Series A
Preferred Stock is
convertible into 1,000
shares of our common stock
at any time at the option
of the holder, provided
that the holder will be
prohibited from converting
Series A Preferred Stock
into shares of our common
stock if, as a result of
such conversion, the
holder, together with its
affiliates, would own more
than 9.98% of the total
number of shares of our
common stock then issued
and outstanding. |
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Liquidation Preference
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In the event of our
liquidation, dissolution,
or winding up, holders of
our Series A Preferred
Stock will receive a
payment equal to $0.001 per
share of Series A Preferred
Stock before any proceeds
are distributed to the
holders of our common
stock. |
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Voting Rights
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Shares of Series A
Preferred Stock will
generally have no voting
rights, except as required
by law and except that the
consent of holders of a
majority of the outstanding
Series A Preferred Stock
will be required to amend
the terms of the Series A
Preferred Stock. |
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Dividends
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Shares of Series A
Preferred Stock will not be
entitled to receive any
dividends, unless and until
specifically declared by
our board of directors. |
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Listing
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We are not listing our
Series A Preferred Stock on
an exchange or any trading
system and we do not expect
that a trading market for
our Series A Preferred
Stock will develop. |
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Warrants to Purchase Shares of Common Stock |
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Warrants
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Warrants to purchase up to
6,685,000 shares of common
stock will be offered in
this offering. This
prospectus also relates to
the offering of the shares
of common stock issuable
upon exercise of the
warrants. |
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Warrant Exercise Price
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The warrants will be
exercisable at an initial
exercise price of $1.65 per
share. |
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Warrant Exercisability and Expiration
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The warrants are
exercisable at any time on
or after the date that is
six months after the date
of issuance and expire on
the date that is four years
after the date of issuance. The holder will not have the right to
exercise any portion of a warrant if the holder (together with its
affiliates) would beneficially own in excess of 9.98% of our common
stock outstanding immediately after giving effect to the exercise. |
S-3
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Use of Proceeds
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We estimate that our net proceeds from this offering,
after deducting our estimated offering expenses, will be
approximately $19.8 million. |
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We intend to use the net proceeds of this offering to fund
research and development, including clinical trials of our
drug candidates, and for general corporate purposes. See
Use of Proceeds on page S-10 of this prospectus
supplement. |
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Risk Factors
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Investing in our common stock, our Series A Preferred Stock
and/or warrants to purchase shares of our common stock
involves a high degree of risk. See Risk Factors on page
S-5 of this prospectus supplement. |
The number of shares of common stock to be outstanding immediately after this offering as reflected
above is based on the actual number of shares outstanding as of April 14, 2011, which was
66,916,100, and does not include, as of that date:
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8,070,000 shares of common stock issuable upon the conversion of the
Series A Preferred Stock offered pursuant to this prospectus; |
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6,685,000 shares of common stock issuable upon the exercise of
warrants offered pursuant to this prospectus at an initial exercise price of
$1.65 per share; |
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10,074,867 shares of our common stock issuable upon exercise of
outstanding options granted under our stock option plans at a weighted
average exercise price of $3.66 per share; |
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4,027,300 shares of our common stock issuable upon exercise of
outstanding warrants at a weighted average price of $3.44 per share;
and |
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3,570,118 shares of common stock reserved for future awards under our
stock option plans and employee stock purchase plan. |
S-4
RISK FACTORS
An investment in our common stock, Series A Preferred Stock and warrants to purchase our common
stock involves a high degree of risk. Before you make a decision to invest in our common stock,
Series A Preferred Stock or warrants to purchase shares of our common stock, you should consider
carefully the risks described below, together with other information in this prospectus supplement,
the accompanying prospectus and the information incorporated by reference herein and therein. If
any of the following events actually occur, our business, operating results, prospects or financial
condition could be materially and adversely affected. This could cause the trading price of our
common stock and/or the value of our Series A Preferred Stock to decline and you may lose all or
part of your investment. These risks are not the only ones that we face. Additional risks not
presently known to us or that we currently deem immaterial may also affect our business operations.
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,
which 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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announcements concerning any of the clinical trials for our compounds, such as omecamtiv
mecarbil for heart failure and CK-2017357 and CK-2066260 for the potential treatment of
diseases associated with aging, muscle wasting and neuromuscular dysfunction (including,
but not limited to, the timing of initiation or completion of such trials and the results
of such trials, and delays or discontinuations of such trials, including delays resulting
from slower than expected or suspended patient enrollment or discontinuations resulting
from a failure to meet pre-defined clinical end-points); |
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announcements concerning our strategic alliance with Amgen or future strategic
alliances; |
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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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issuance of new or changed securities analysts reports or recommendations; |
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failure or delay in establishing new strategic alliances, or the terms of those
alliances; |
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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 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; |
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substantial sales of our common stock by our existing shareholders, whether or not
related to our performance; or |
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volatility in the stock prices of other companies in our industry or in the stock market
generally. |
S-5
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 February 28, 2011, our executive officers, directors and their affiliates beneficially
owned or controlled approximately 13.6% 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.
Risks Relating to this Offering
Our management will have broad discretion over the use of the net proceeds from this offering, you
may not agree with how we use the proceeds, and the proceeds may not be invested successfully.
Our management will have broad discretion as to the use of the net proceeds from any offering
by us and could use them for purposes other than those contemplated at the time of this offering.
Accordingly, you will be relying on the judgment of our management with regard to the use of these
net proceeds, and you will not have the opportunity as part of your investment decision to assess
whether the proceeds are being used appropriately. It is possible that the proceeds will be
invested in a way that does not yield a favorable, or any, return for our company.
You will experience immediate and substantial dilution in the book value per share of the common
stock you purchase.
Because the price per share of our common stock being offered is substantially higher than the
net tangible book value per share of our common stock, you will suffer substantial dilution in the
net tangible book value of the common stock you purchase in this offering. After giving effect to
the sale by us of 5,300,000 shares of our common stock at a purchase price of $1.50 per share,
8,070 shares of our Series A Preferred Stock at a purchase price of $1,500.00 per share, and
warrants to purchase 6,685,000 shares of our common stock with an initial exercise price of $1.65
per share in this offering, and a net tangible book value per share of our common stock of $1.05 as
of December 31, 2010, if you purchase shares of common stock in this offering, you will suffer
immediate and substantial dilution of $0.38 per share in the net tangible book value of the common
stock.
You may experience future dilution as a result of future equity offerings and other issuances of
our common stock or other securities.
In order to raise additional capital, we may in the future offer additional shares of our
common stock or other securities convertible into or exchangeable for our common stock, including
convertible debt. We cannot assure you that we will be able to sell shares or other securities in
any other offering at a price per share that is equal to or greater than the price per share paid
by investors in this offering, and investors purchasing shares or other securities in the future
could have rights superior to existing stockholders. The price per share at which we sell
additional shares of our common stock or other securities convertible into or exchangeable for our
common stock in future transactions may be higher or lower than the price per share in this
offering. As of December 31, 2010, 5,557,009 shares of common stock were reserved for future
issuance under our stock option plans and employee stock purchase plan. As of that date, there were
also options outstanding to purchase 8,096,476 shares of our common stock and warrants outstanding
to purchase 4,027,300 shares of our common stock. You will incur dilution
S-6
upon the grant of any shares under our stock option plans or upon exercise of any outstanding
stock options or warrants.
Our Series A Convertible Preferred Stock has never been publicly traded and an active trading
market for such stock is not expected to develop.
Prior to this offering, there has been no public market for our Series A Preferred Stock. We
are not listing our Series A Preferred Stock on an exchange or any trading system and we do not
expect that a trading market for our Series A Preferred Stock will develop.
Our Series A Preferred Stock will rank junior to all our liabilities to third party creditors, and
to any class or series of our capital stock created after this offering specifically ranking by its
terms senior to the Series A Preferred Stock, in the event of a bankruptcy, liquidation or winding
up of our assets.
In the event of bankruptcy, liquidation or winding up, our assets will be available to pay
obligations on our Series A Preferred Stock only after all our liabilities have been paid. Our
Series A Preferred Stock will effectively rank junior to all existing and future liabilities held
by third party creditors. The terms of our Series A Preferred Stock do not restrict our ability to
raise additional capital in the future through the issuance of debt. Our Series A Preferred Stock
will also rank junior to any class or series of our capital stock created after this offering
specifically ranking by its terms senior to the Series A Preferred Stock. In the event of
bankruptcy, liquidation or winding up, there may not be sufficient assets remaining, after paying
our liabilities, to pay amounts due on any or all of our Series A Preferred Stock then outstanding.
S-7
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents we incorporate by reference in this prospectus include
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, which we refer to as the Securities Act, and Section 21E of the Securities Exchange Act of
1934, as amended, which we refer to as the Exchange Act, that involve substantial risks and
uncertainties. All statements, other than statements of historical fact that we include in this
prospectus and in the documents we incorporate by reference in this prospectus, including
statements regarding our strategy, future operations, future financial position, future results of
operations, future cash flows, projected costs, financing plans, product development, possible
strategic alliances, competitive position, prospects, plans and objectives of management, may be
deemed forward-looking statements for purposes of the Securities Act and the Exchange Act. We often
use words such as anticipate, estimate, expect, project, intend, plan, believe,
may, predict, will, and would, and similar expressions, to identify forward-looking
statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, among other things, statements about:
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guidance concerning revenues, research and development expenses and general and
administrative expenses for 2011; |
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the sufficiency of existing resources to fund our operations for at least the next 12
months; |
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our capital requirements and needs for additional financing; |
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the initiation, design, progress, timing and scope of clinical trials and development
activities for our drug candidates and potential drug candidates conducted by ourselves or
our partners, such as Amgen, Inc. (Amgen), including the anticipated timing for
initiation of clinical trials and anticipated dates of data becoming available or being
announced from clinical trials; |
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the results from the clinical trials and non-clinical and pre-clinical studies of our
drug candidates and other compounds, and the significance and utility of such results; |
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our plans to file an IND for CK-2066260 with the FDA; |
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our and our partners, such as Amgens, plans or ability to conduct the continued
research and development of our drug candidates and other compounds; |
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our expected roles in research, development or commercialization under our strategic
alliances, such as with Amgen; |
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the properties and potential benefits of, and the potential market opportunities for,
our drug candidates and other compounds, including the potential indications for which they
may be developed; |
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the sufficiency of the clinical trials conducted with our drug candidates to demonstrate
that they are safe and efficacious; |
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our receipt of milestone payments, royalties, reimbursements and other funds from
current or future partners under strategic alliances, such as with Amgen; |
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our plans to seek strategic alternatives for our mitotic kinesin inhibitor drug
candidates with third parties; |
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our ability to continue to identify additional potential drug candidates that may be
suitable for clinical development; |
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our plans or ability to commercialize drugs with or without a partner, including our
intention to develop sales and marketing capabilities; |
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the focus, scope and size of our research and development activities and programs; |
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the utility of our focus on the cytoskeleton and our ability to leverage our experience
in muscle contractility to other muscle functions; |
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our ability to protect our intellectual property and to avoid infringing the
intellectual property rights of others; |
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expected future sources of revenue and capital; |
S-8
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losses, costs, expenses and expenditures; |
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future payments under loan and lease obligations and equipment financing lines; |
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potential competitors and competitive products; |
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retaining key personnel and recruiting additional key personnel; |
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expected future amortization of employee stock-based compensation; and |
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the potential impact of recent accounting pronouncements on our financial position or
results of operations. |
Such forward-looking statements involve risks and uncertainties, including, but not limited
to, those risks and uncertainties relating to:
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Amgens decisions with respect to the timing, design and conduct of development
activities for omecamtiv mecarbil, including decisions to postpone or discontinue research
or development activities relating to omecamtiv mecarbil; |
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our ability to obtain additional financing; |
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our receipt of funds and access to other resources under our current or future strategic
alliances; |
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difficulties or delays in the development, testing, production or commercialization of
our drug candidates; |
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difficulties or delays in or slower than anticipated patient enrollment in our or our
partners clinical trials; |
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adverse side effects, including potential drug-drug interactions, or inadequate
therapeutic efficacy of our drug candidates that could slow or prevent product approval
(including the risk that current and past results of preclinical research or non-clinical
or clinical development may not be indicative of future clinical trials results); |
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results from non-clinical studies that may adversely impact the timing or the further
development of our drug candidates and potential drug candidates; |
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the possibility that the FDA or foreign regulatory agencies may delay or limit our or
our partners ability to conduct clinical trials or may delay or withhold approvals for the
manufacture and sale of our products; |
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activities and decisions of, and market conditions affecting, current and future
strategic partners; |
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our ability to enter into partnership agreements for any of our programs on acceptable
terms and conditions or in accordance with our planned timelines; |
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the availability of funds under our grant from the National Institute of Neurological
Disorders and Stroke in future periods; |
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changing standards of care and the introduction of products by competitors or
alternative therapies for the treatment of indications we target that may make our drug
candidates commercially unviable; |
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the uncertainty of protection for our intellectual property, whether in the form of
patents, trade secrets or otherwise; and |
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potential infringement or misuse by us of the intellectual property rights of third
parties. |
Our actual results may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including the factors described under Risk
Factors beginning on page S-5 of this prospectus supplement and those incorporated herein by
reference. These important factors include the factors that we identify in the documents that we
incorporate by reference in this prospectus. If one or more of these factors materialize, or if any
underlying assumptions prove incorrect, our actual results, performance or achievements may vary
materially from any future results, performance or achievements expressed or implied by these
forward-looking statements. You should consider these factors and the other cautionary statements
made in this prospectus or the documents we incorporate by reference as being applicable to all
related forward-looking statements wherever they appear in this prospectus or the documents
incorporated by reference. We do not assume, and specifically disclaim, any obligation to publicly
update forward-looking statements, whether as a result of new information, future events or
otherwise. Operating results reported are not necessarily indicative of results that may occur in
future periods.
S-9
USE OF PROCEEDS
We estimate the net proceeds from the sale of 5,300,000 shares of our common stock, 8,070 shares of
our Series A Preferred Stock and warrants to purchase 6,685,000 shares of our common stock that we
are offering will be approximately $19.8 million, after deducting the estimated expenses related to
the offering payable by us.
We currently intend to use the net proceeds from the sale of shares of our common stock for:
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research and development, including clinical trials for our drug candidates; and |
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working capital and other general corporate purposes. |
We cannot estimate precisely the allocation of the net proceeds from this offering among these
uses. The amount that we actually expend for these purposes 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 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 application of the net proceeds, we intend to invest the net proceeds in a variety of
capital preservation instruments, including direct or guaranteed obligations of the U.S.
government, certificates of deposit and money market funds, in accordance with our investment
policy.
S-10
DILUTION
If you purchase our common stock, our Series A Preferred Stock or warrants to purchase shares of
our common stock in this offering, your interest will be diluted to the extent of the difference
between the public offering price per share and the net tangible book value per share of our common
stock after this offering. We calculate net tangible book value per share by subtracting our total
liabilities from our total tangible assets and dividing the difference by the number of outstanding
shares of our common stock.
Our net tangible book value on December 31, 2010 was approximately $70.5 million, or $1.05 per
share. Net tangible book value is total assets minus the sum of liabilities and intangible
assets. Net tangible book value per share is net tangible book value divided by the total number
of shares outstanding.
After giving effect to the sale of 5,300,000 shares of common stock and 8,070 shares of Series A
Preferred Stock by us in this offering, and assuming the conversion of 8,070 shares of our Series A
Preferred Stock into 8,070,000 shares of our common stock, our as adjusted net tangible book value
on December 31, 2010 would have been approximately $90.3 million, or $1.12 per share. This
represents an immediate increase in net tangible book value of approximately $0.07 per share to
existing stockholders and an immediate dilution in net tangible book value of approximately $0.38
per share to the investors in this offering. The following table illustrates this per share
dilution:
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Offering price per share of common stock |
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1.50 |
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Offering price per share of Series A Preferred Stock |
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$ |
1,500.00 |
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Net tangible book value per share as of December 31, 2010 |
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1.05 |
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Increase per share attributable to this offering |
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$ |
0.07 |
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As adjusted net tangible book value per share after this offering |
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$ |
1.12 |
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Dilution per share to investors participating in this offering |
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$ |
0.38 |
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The above discussion and table are based on 66,907,600 shares of our common stock outstanding as of
December 31, 2010. The information above excludes:
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8,096,476 shares of our common stock issuable upon exercise of outstanding stock options
under our stock option plans as of December 31, 2010, at a weighted average exercise price
of $4.32; |
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4,027,300 shares of our common stock issuable upon exercise of outstanding warrants at a
weighted average price of $3.44 per share; |
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5,557,009 shares of our common stock available as of December 31, 2010 reserved for
future awards under our stock option plans and employee stock purchase plans; and |
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6,685,000 shares of common stock issuable upon the exercise of warrants offered pursuant
to this prospectus at an initial exercise price of $1.65 per share. |
To the extent that outstanding options or warrants are exercised, investors purchasing our common
stock, our Series A Preferred Stock or warrants to purchase our common stock in this offering will
experience further dilution. In addition, we may choose to raise additional capital due to market
conditions or strategic considerations even if we believe we have sufficient funds for our current
or future operating plans. To the extent that additional capital is raised through the sale of
equity or convertible debt securities, the issuance of these securities could result in further
dilution to our stockholders.
S-11
PLAN OF DISTRIBUTION
We are selling 5,300,000 shares of our common stock at a price of $1.50 per share, 8,070 shares of
our Series A Preferred Stock at a price of $1,500.00 per share, and warrants to purchase 6,685,000
shares of our common stock with an initial exercise price of $1.65 per share, under this prospectus
supplement and the accompanying prospectus directly to certain institutional investors pursuant to
a securities purchase agreement. We currently anticipate that the closing of the sale of such
shares under this agreement will take place on or about April 20, 2011. On the closing date, we
will issue the shares of our common stock, shares of Series A Preferred Stock and warrants to
purchase shares of common stock to the investors and receive funds in the amount of the aggregate
purchase price.
S-12
DESCRIPTION OF SECURITIES WE ARE OFFERING
The securities offered in this offering will be issued pursuant to a securities purchase agreement
between each of the purchasers and us. The terms of our Series A Preferred Stock are contained in a
certificate of designation of preferences that will amend our amended and restated certificate of
incorporation, as amended. We have previously filed with the SEC copies of our amended and restated
certificate of incorporation, as amended. See Where You Can Find More Information. This
description of the securities in this prospectus supplement is qualified in its entirety by
reference to the securities purchase agreement, the certificate of designation of preferences and
the warrants. You should review the form of securities purchase agreement, the form of the
certificate of designation of preferences and the form of warrant, each of which have been filed by
us as an exhibit to a Current Report on Form 8-K filed with the Securities and Exchange Commission
in connection with this offering, for a complete description of the terms and conditions applicable
to the securities.
Common Stock
The material terms and provisions of our common stock and each other class of our securities which
qualifies or limits our common stock are described under the caption Description of Capital Stock
starting on page 30 of the accompanying prospectus.
Series A Preferred Stock
General
Our certificate of incorporation authorizes our board of directors to issue up to 10,000,000 shares
of our preferred stock, par value $0.001 per share.
Subject to the limitations prescribed by our certificate of incorporation, our board of directors
is authorized to establish the number of shares constituting each series of preferred stock and to
fix the designations, powers, preferences and rights of the shares of each of those series and the
qualifications, limitations and restrictions of each of those series, all without any further vote
or action by our stockholders. Our board of directors has designated 8,070 of the 10,000,000
authorized shares of preferred stock as Series A Preferred Stock. When issued, the shares of Series
A Preferred Stock will be validly issued, fully paid and non-assessable.
Rank
The Series A Preferred Stock will rank:
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senior to all of our common stock; |
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senior to any class or series of our capital stock hereafter created specifically
ranking by its terms junior to the Series A Preferred Stock; |
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on parity with any class or series of our capital stock hereafter created specifically
ranking by its terms on parity with the Series A Preferred Stock; and |
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junior to any class or series of our capital stock hereafter created specifically
ranking by its terms senior to the Series A Preferred Stock; |
in each case, as to distributions of assets upon our liquidation, dissolution or winding up whether
voluntarily or involuntarily.
Conversion
Each share of our Series A Preferred Stock is convertible into 1,000 shares of our common stock
(subject to adjustment as provided in the related certificate of designation of preferences) at any
time at the option of the holder, provided that the holder will be prohibited from converting
Series A Preferred Stock into shares of our common stock if, as a result of such conversion, the
holder, together with its affiliates, would own more than 9.98% of the total number of shares of
our common stock then issued and outstanding.
S-13
Liquidation Preference
In the event of our liquidation, dissolution, or winding up, holders of our Series A Preferred
Stock will receive a payment equal to $0.001 per share of Series A Preferred Stock before any
proceeds are distributed to the holders of our common stock.
Voting Rights
Shares of Series A Preferred Stock will generally have no voting rights, except as required by law
and except that the consent of holders of a majority of the outstanding Series A Preferred Stock
will be required to amend the terms of the Series A Preferred Stock.
Dividends
Shares of Series A Preferred Stock will not be entitled to receive any dividends, unless and until
specifically declared by our board of directors.
Redemption
We are not obligated to redeem or repurchase any shares of Series A Preferred Stock. Shares of
Series A Preferred Stock are not otherwise entitled to any redemption rights, or mandatory sinking
fund or analogous fund provisions.
Warrants to Purchase Shares of Common Stock
The following is a brief summary of the warrants to purchase shares of common stock and is subject
in all respects to the provisions contained in the warrants.
Exercisability. The warrants are exercisable at any time on or after the date that is six
months after the date of issuance and expire on the date that is four years after the date of
issuance. Each warrant will be exercisable in whole or in part, at holders option, by the holder
delivering to us a duly executed exercise notice accompanied by payment in full for the number of
shares of our common stock to be purchased upon such exercise (except in the case of a cashless
exercise as discussed below). The holder will not have the right to exercise any portion of the
warrant if the holder (together with its affiliates) would beneficially own in excess of 9.98% of
our common stock outstanding immediately after giving effect to the exercise.
Cashless Exercise. When exercising a warrant, the warrant holder may elect to exercise the
warrant through a cashless exercise. This means that at the time of exercise, rather than the
warrant holder paying for the shares of our common stock to be purchased through such exercise, we
will instead cancel the portion of the warrant that represents the number of shares of our common
stock that, when multiplied by the then-current market price of the shares (calculated as set forth
in the warrants), have a value equal to the purchase price for all of the shares of our common
stock being purchased through such exercise at the exercise price.
Exercise Price. The initial per share exercise price of the warrants is $1.65.
Transferability. Subject to the conditions on transfer set forth in the warrants, the warrants
may be offered for sale, sold, transferred or assigned without our consent.
Exchange Listing. We do not plan on making an application to list the warrants on the NASDAQ
Global Market, any other national securities exchange or other nationally recognized trading
system.
Major Transactions. If we enter into, or are a party to, a Major Transaction, which is a
merger or other change of control transaction, as defined in the warrants, then (1) to the extent
of the percentage of the cash consideration in the Major Transaction, the holder of such
warrant, at its option, may require the Company to redeem such holders outstanding warrants and
(2) to the extent of the percentage of the consideration represented by securities of a successor
entity, as defined in the warrants, the warrant holder shall have the right to exercise such
warrant as a Cashless Major Exercise, as defined in the warrants.
S-14
Events of Failure. In the event that a Delivery Failure or Transfer Delivery Failure, each
as defined in the warrants, occurs, the Company is required to pay to the warrant holders certain
liquidated damages as described in the warrants.
Rights as a Stockholder. Except as otherwise provided in the warrants or by virtue of a
holders ownership of shares of our common stock, a warrant holder will not have the rights or
privileges of our common stockholders, including any voting rights, until it exercises the warrant.
Waivers and Amendments. Except as otherwise provided in the warrants, the provisions of the
warrants may be amended and we may take any action prohibited by the warrants or omit to perform
any act required to be performed by the warrants upon the written consent of the warrant holders.
S-15
LEGAL MATTERS
The validity of the issuance of the shares of common stock, shares of Series A Preferred Stock and
warrants to purchase shares of common stock offered by this prospectus will be passed upon for us
by Cooley LLP, Palo Alto, California.
EXPERTS
PricewaterhouseCoopers LLP, an independent registered
public accounting firm, has audited our
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2010 and the effectiveness of our internal control over financial reporting as of December 31,
2010, as set forth in their reports, which are incorporated by reference in this prospectus
supplement and elsewhere in the registration statement. The financial statements and managements
assessment of the effectiveness of internal control over financial reporting (which is included in
Managements Report on Internal Control over Financial Reporting) incorporated in this prospectus supplement
by reference to the Annual Report on Form 10-K for the year ended December 31, 2010 have been so
incorporated in reliance on the report(s) 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
This prospectus supplement and accompanying prospectus constitute a part of a registration
statement on Form S-3 that we filed on November 10, 2008 with the SEC under the Securities Act. We
refer you to this registration statement for further information about us and the common stock
offered hereby.
We file annual, quarterly and special reports and other information with the SEC (Commission File
Number 000-50633). These filings contain important information that does not appear in this
prospectus supplement or the accompanying prospectus. For further information about us, you may
read and copy any reports, statements and other information filed by us at the SECs Public
Reference Room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549-0102. You may obtain
further information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our SEC filings are also available on the SEC Internet site at www.sec.gov, which
contains periodic reports and other information regarding issuers that file electronically.
We also maintain a website at www.cytokinetics.com, through which you can access our filings with
the SEC. The information contained in, or accessible through, our website is not a part of this
prospectus supplement.
S-16
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference information into this prospectus, which means that
we can disclose important information to you by referring you to other documents that we have filed
or will file with the SEC. We are incorporating by reference in this prospectus:
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2010, which was
filed on March 11, 2011; |
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our Current Reports on Form 8-K filed on January 4, 2011; February 9, 2011; February 10,
2011; February 14, 2011 (as to information therein explicitly filed with the SEC only);
March 1, 2011; and March 18, 2011; and |
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the description of our common stock contained in our Registration Statement on Form 8-A,
filed with the SEC on March 12, 2004, including any amendment or reports filed for the
purpose of updating such description. |
All documents that we file with the SEC pursuant to Section 13(a), 13(c) or 15(d) of the Exchange
Act after the date of this prospectus supplement and before the termination or completion of this
offering of common stock shall be deemed to be incorporated by reference in this prospectus
supplement and to be a part of it from the filing dates of such documents (except in each case the
information contained in such documents to the extent furnished and not filed). Certain
statements in and portions of this prospectus supplement update and replace information in the
above listed documents incorporated by reference. Likewise, statements in or portions of a future
document incorporated by reference in this prospectus supplement may update and replace statements
in and portions of this prospectus supplement or the above listed documents.
We will provide without charge to each person, including any beneficial owner, to whom a copy of
this prospectus is delivered, upon written or oral request of any such person, a copy of any or all
of the documents that are incorporated herein by reference. Requests should be directed to:
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, California 94080
United States of America
Attn: Investor Relations
(650) 624-3000
In accordance with Section 412 of the Exchange Act, any statement contained in a document
incorporated by reference herein shall be deemed modified or superseded to the extent that a
statement contained herein or in any other subsequently filed document which also is or is deemed
to be incorporated by reference herein modifies or supersedes such statement.
S-17
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 Global Market under the trading symbol CYTK. On November 7, 2008 the last reported sale
price of our common stock on the NASDAQ Global Market was $2.79 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 November 19, 2008
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 biopharmaceutical company focused on developing small molecule
therapeutics for the potential treatment of cardiovascular diseases and other diseases relating to
muscle biology, cancer and other diseases. Our current clinical development activities are
primarily directed to advancing multiple drug candidates through clinical trials with the objective
of determining the intended pharmacodynamic effect or effects in two principal diseases: heart
failure and cancer. Our drug development pipeline consists of a drug candidate, CK-1827452, being
developed in both an intravenous and oral formulation for the potential treatment of heart failure;
three drug candidates, ispinesib, SB-743921 and GSK-923295, each being developed in an intravenous
formulation for the potential treatment of cancer; and a potential drug candidate for the potential
treatment of skeletal muscle weakness associated with neuromuscular diseases or other conditions.
Our drug candidates and potential drug candidate are all novel small molecules that arose from our
research activities and are directed toward the cytoskeleton. We believe our understanding of the
cytoskeleton enables us to discover novel and potentially safer and more effective therapeutics.
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 and our logo used alone and with the mark CYTOKINETICS 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 our 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 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 more 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 or are significantly delayed 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 (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. CK-1827452, our drug candidate for the potential
treatment of heart failure, and ispinesib, SB-743921 and GSK-923295, our drug candidates for the
potential 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 future drug candidate 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 clinical testing or
commercialization. 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.
-2-
We currently finance and plan to continue to finance our operations through the sale of equity,
strategic alliances and debt financings, which may result in additional dilution to our
stockholders, relinquishment of valuable technology rights or the imposition of restrictive
covenants, or which may cease to be available on favorable terms or at all.
We have funded all of our operations and capital expenditures with proceeds from private and
public sales of our equity securities, strategic alliances with GlaxoSmithKline (GSK), Amgen,
Inc., AstraZeneca AB and others, equipment financings, interest on investments and government
grants. We believe that our existing cash and cash equivalents, potential payments from GSK and
Amgen, interest earned on investments, proceeds from equipment financings and potential proceeds
from our 2007 committed equity financing facility with Kingsbridge Capital Limited (Kingsbridge)
will be sufficient 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, strategic alliances or debt financings. 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 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. To the extent that we raise additional
funds through debt financing, the financing may involve covenants that restrict our business
activities. In addition, such funding, if needed, may not be available to us on favorable terms,
or at all. If we can not raise the funds we need on favorable terms, or at all, our ability to
conduct our business will be significantly harmed and we may need to discontinue certain research
and development activities, and our stock price could be negatively affected.
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 adequately
demonstrate to the FDA and foreign regulatory authorities that the drug candidate is both
sufficiently safe and effective with substantial evidence from well-controlled 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 and possibly following approval. None
of our drug candidates have yet been demonstrated to be safe and effective in clinical trials and
they may never be. In addition, for each of our current preclinical compounds, we must adequately
demonstrate satisfactory chemistry, formulation, stability and toxicity in order to file an
investigational new drug application (IND) with the FDA, or an equivalent application in foreign
jurisdictions, that would allow us to advance that compound into clinical trials. If our current
or future preclinical studies or clinical trials are unsuccessful, our business will be
significantly harmed and our stock price could 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 adequately support the filing of an IND (or a
foreign equivalent) with respect to our potential drug candidates. Even if these applications are
or have been filed with respect to our drug candidates, the results of preclinical studies do not
necessarily predict the results of clinical trials. For example, although preclinical testing
indicated that ispinesib causes tumor regression in a variety of tumor types, to date, Phase II
clinical trials of ispinesib have not shown clinical activity in a number of different tumor types.
Similarly, Phase I clinical trials in healthy volunteers and clinical results from Phase I and II
trials in patients are not necessarily indicative of the results of later-stage clinical trials
that are necessary to establish whether a drug candidate is safe and effective for the applicable
indication. In addition, the clinical
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trials for any of our drug candidates may not be designed with focus on the appropriate
indications, tumor types, patient populations, dosing regimens, safety or efficacy parameters, or
other variables to provide the necessary safety or efficacy data to support regulatory approval to
commercialize the resulting drugs. For example, in a number of two-stage Phase II clinical trials
designed to evaluate the safety and efficacy of ispinesib as monotherapy in the first- or
second-line treatment of patients with different forms of cancer, ispinesib did not satisfy the
criteria for advancement to Stage 2. Also, the methods we select to assess particular safety or
efficacy parameters may not yield the same statistical precision in estimating our drug candidates
effects as may other alternative methodologies. Even if we believe the data collected from
clinical trials of our drug candidates are promising, these data may not be sufficient to support
approval by the FDA or foreign regulatory authorities. Preclinical and clinical data can be
interpreted in different ways. Accordingly, the FDA or foreign regulatory authorities could
interpret these 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 may produce undesirable
side effects, also known as adverse effects. Toxicities and adverse effects observed in
preclinical studies for some compounds in a particular research and development program may also
occur in preclinical studies or clinical trials of other compounds from the same program.
Potential toxicity issues may arise from the effects of the active pharmaceutical ingredient
(API) itself or from impurities or degradants that are present in the API or could form over time
in the formulated drug candidate or the API. These toxicities or adverse effects could delay or
prevent the filing of an IND (or a foreign equivalent) with respect to our drug candidates or
potential drug candidates or cause us to cease clinical trials with respect to any drug candidate.
In clinical trials, administering any of our drug candidates to humans may produce adverse effects.
For example, in clinical trials of ispinesib, the most commonly observed 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 were: prolonged neutropenia, with or without fever and with or
without infection; elevated transaminases and hyperbilirubinemia, both of which are abnormalities
of liver function; and hyponatremia, which is a low concentration of sodium in the blood. In a
Phase I clinical trial of CK-1827452, intolerable doses of CK-1827452 were associated with
complaints of chest discomfort, palpitations, dizziness and feeling hot, increases in heart rate,
declines in blood pressure, electrocardiographic changes consistent with acute myocardial ischemia
and transient rises in cardiac troponins I and T, which are markers of possible myocardial injury.
If these or other adverse effects are severe or frequent enough to outweigh the potential efficacy
of a drug candidate, our clinical trials for that drug candidate may be halted, delayed or
interrupted. Furthermore, the FDA or other regulatory authorities could deny approval of that drug
candidate for any or all targeted indications. The FDA, other regulatory authorities, our partners
or we may suspend or terminate clinical trials with our drug candidates at any time. Even if one
or more of our drug candidates were approved for sale as drugs, 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 those drugs. Indications of potential adverse
effects or toxicities which do not seem significant during the course of clinical trials may later
turn out to actually constitute serious adverse effects or toxicities when a drug is 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 resulting drugs, may significantly harm our business and
negatively affect our stock price.
Clinical trials are expensive, time-consuming and subject to delay.
Clinical trials are subject to rigorous regulatory requirements and are very expensive,
difficult and time-consuming to design and implement, especially in the heart failure and cancer
indications that we are pursuing. According to industry studies, the entire drug development and
testing process takes on average 12
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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. The length of time and number
of trial sites and patients required for clinical trials vary substantially based on the type,
complexity, novelty, intended use of the drug candidate and safety concerns. 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 commencement and completion of our clinical trials
could be delayed or prevented by many factors, including, but not limited to:
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delays in obtaining, or inability to obtain, regulatory or other approvals to
commence and conduct clinical trials in the manner we or our partners deem necessary
for the appropriate and timely development of our drug candidates and commercialization
of any resulting drugs; |
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delays in identifying and reaching agreement, or inability to identify and reach
agreement, on acceptable terms with prospective clinical trial sites; |
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delays or additional costs in developing, or inability to develop, appropriate
formulations of our drug candidates for clinical trial use; |
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slower than expected rates of patient recruitment and enrollment, including as a
result of competition for patients with other clinical trials; limited numbers of
patients that meet the enrollment criteria; patients, investigators or trial sites
reluctance to agree to the requirements of a protocol; or the introduction of
alternative therapies or drugs by others; |
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for those drug candidates that are the subject of a strategic alliance, delays in
reaching agreement with our partner as to appropriate development strategies; |
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an investigational review board (IRB) may require changes to a protocol that then
require approval from regulatory agencies and other IRBs, or regulatory authorities may
require changes to a protocol that then require approval from the IRBs; |
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for clinical trials conducted in foreign countries, the time and resources required
to identify, interpret and comply with foreign regulatory requirements or changes in
those requirements, and political instability or natural disasters occurring in those
countries; |
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lack of effectiveness of our drug candidates during clinical trials; |
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unforeseen safety issues; |
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inadequate supply of clinical trial materials; |
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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. |
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We do not know whether planned clinical trials will begin on time, or whether planned or
currently ongoing clinical trials 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 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 will
require additional funding.
The development of drug candidates is complicated, and we currently have limited resources to
carry out drug development. Pursuant to our collaboration and option agreement with Amgen, we are
responsible for conducting Phase IIa clinical development for our drug candidate CK-1827452. We
cannot engage another strategic partner for CK-1827452, except in Japan, until Amgen elects not to
exercise its option to conduct later-stage clinical development for CK-1827452 or its option
expires. If Amgen elects not to exercise its option, we currently do not have an alternative
strategic partner for that drug candidate. Pursuant to our amended collaboration and license
agreement with GSK, we are responsible for conducting clinical development for our drug candidates
ispinesib and SB-743921. Currently, we rely on GSK to conduct preclinical and clinical development
for GSK-923295. We cannot engage another strategic partner for ispinesib or SB-743921 until GSKs
option to conduct later-stage clinical development for those drug candidates expires. If GSK
elects to terminate its development activities with respect to GSK-923295, or not to exercise its
option to conduct later-stage clinical development for either of ispinesib or SB-743921, we
currently do not have an alternative strategic partner for these drug candidates.
We are conducting clinical trials, at our expense, for CK-1827452, ispinesib and SB-743921. We
rely on contractors for the manufacture and distribution of clinical supplies. If we continue to
conduct clinical trials for any of these drug candidates without support from a strategic partner,
we will need to develop additional skills, technical expertise and resources necessary to carry out
these development activities on our own or through the use of other third parties, such as contract
research organizations (CROs), and will incur significant costs.
We utilize CROs for our clinical trials within and outside of the United States. We do not
have control over many aspects of our CROs activities, and cannot fully control the amount, timing
or quality of resources that they devote to our programs. CROs may not assign as high a priority
to our programs or pursue them as diligently as we would if we were undertaking these programs
ourselves, and therefore may not complete their respective activities on schedule. CROs may also
give higher priority to relationships with our competitors and potential competitors than to their
relationships with us. Outside of the United States, we are particularly dependent on our CROs
expertise in communicating with clinical trial sites and regulatory authorities and ensuring that
our clinical trials and related activities and regulatory filings comply with applicable local
laws. Our CROs failure to carry out development activities on our behalf according to our
requirements and the FDAs or other regulatory agencies standards and in accordance with
applicable laws, or our failure to properly coordinate and manage these activities, could increase
the cost of our operations and delay or prevent the development, approval and commercialization of
our drug candidates. In addition, if a CRO fails to perform as agreed, our ability to collect
damages may be contractually limited.
If we fail to develop the additional skills, technical expertise and resources necessary to
carry out the development of our drug candidates or to effectively manage our CROs carrying out
this development, or if our CROs fail to perform as agreed, the commercialization of our drug
candidates will be delayed or prevented.
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If we fail to enter into and maintain successful strategic alliances for our drug candidates,
potential drug candidates or research and development programs, we will have to reduce, delay or
discontinue our advancement of those drug candidates, potential drug candidates and programs or
increase our expenditures.
Our strategy for developing, manufacturing and commercializing our drug candidates and
potential 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 currently have strategic alliances with Amgen relating
to CK-1827452 and with GSK relating to ispinesib, SB-743921 and GSK-923295. Similarly, we expect
to rely on one or more strategic partners to advance and develop our potential drug candidate
directed towards the skeletal sarcomere and programs relating to skeletal muscle contractility and
smooth muscle contractility. However, we may not be able to negotiate and enter into such
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 will have to limit
the size or scope of, or delay or discontinue, one or more of our drug development programs or
research programs or undertake and fund these programs ourselves. If we elect to continue to
conduct any of these drug development programs or research programs on our own, we will need to
obtain additional capital, which may not be available to us on acceptable terms, or at all.
If Amgen does not exercise its option for CK-1827452, we will have to reduce, delay or discontinue
our development of CK-1827452 or increase our expenditures.
Our collaboration and option agreement with Amgen grants it an option relating to development
and commercialization rights for CK-1827452. Amgens option is exercisable during a defined
period, the ending of which is dependent upon the satisfaction of certain conditions, primarily the
delivery of Phase I and Phase IIa clinical trials data for CK-1827452 in accordance with an agreed
development plan, the results of which reasonably support its progression into Phase IIb clinical
development. Amgen can exercise its option during a defined period by paying us a specified option
fee. We may be unable to provide to Amgen the necessary data to inform its decision as to whether
to exercise its option within our anticipated timeframe, or at all, or Amgen may dispute whether we
have provided sufficient information and data to require Amgen to decide whether to exercise its
option. In addition, Amgen may elect not to exercise its option, irrespective of the data that we
provide. If Amgen elects not to exercise its option for CK-1827452, we would have to seek an
alternative strategic partner for the CK-1827452 development program. However, we may not be able
to negotiate and enter into such a strategic alliance on acceptable terms, if at all. Without a
strategic partner, we would have to limit the size or scope of, or delay or discontinue,
development of CK-1827452 or undertake and fund that development ourselves. If we elect to
continue to conduct development on our own, we will need to obtain additional capital, which may
not be available to us on acceptable terms, or at all. Further, a decision by Amgen not to
exercise its option could negatively affect our stock price.
If GSK does not exercise its option for either or both of ispinesib and SB-743921, we will have to
reduce, delay or discontinue our development of those drug candidates or increase our expenditures.
Our collaboration and license agreement with GSK grants it an option relating to development
and commercialization rights for either or both of ispinesib and SB-743921. GSKs option is
exercisable until the end of 2008. GSK can exercise its option during a defined period by paying
us a specified option fee. We may be unable to provide to GSK the necessary data to inform its
decision as to whether to exercise its option within our anticipated timeframe, or at all. In
addition, GSK may elect not to exercise its option, irrespective of the data that we provide. If
GSK elects not to exercise its option for either or both of ispinesib and SB-743921, we would have
to seek an alternative strategic partner for these programs. However, we may not
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be able to negotiate and enter into such strategic alliances on acceptable terms, if at all. Without a
strategic partner, we would have to limit the size or scope of, or delay or discontinue, one or both of
these programs or undertake and fund these programs ourselves. If we elect to continue to conduct
either program on our own, we will need to obtain additional capital, which may not be available to
us on acceptable terms, or at all. Further, a decision by GSK not to exercise its option could
negatively affect our stock price.
We depend on GSK for the conduct, completion and funding of the clinical development and
commercialization of GSK-923295.
Under our strategic alliance, GSK is responsible for the clinical development and obtaining
and maintaining regulatory approval of our drug candidate GSK-923295 for cancer and other
indications. GSK is responsible for filing applications with the FDA or other regulatory
authorities for approval of GSK-923295 and will be the owner of any marketing approvals issued by
the FDA or other regulatory authorities for GSK-923295. If the FDA or other regulatory authorities
approve GSK-923295, GSK will also be responsible for the marketing and sale of the resulting drug,
subject to our right to co-promote GSK-923295 in North America if we exercise our option to co-fund
certain later-stage development activities for GSK-923295. However, even if we do exercise our
option to co-fund the development of GSK-923295, we cannot control whether GSK will devote
sufficient attention and resources to the clinical trials program for GSK-923295 or will proceed in
an expeditious manner. In addition, even if the FDA or other regulatory agencies approve
GSK-923295, GSK may elect not to proceed with the commercialization of the resulting drug. GSK
generally has discretion to elect whether to pursue or abandon the development of GSK-923295 and
may terminate our strategic alliance for any reason upon six months prior notice. These decisions
are outside our control.
In particular, if the initial results of some of its early clinical trials do not meet GSKs
expectations, GSK may elect to terminate further development of GSK-923295 or certain of the
potential clinical trials for GSK-923295, even if the actual number of patients treated at that
time is relatively small. If GSK abandons GSK-923295, it would result in a delay in or prevent us
from commercializing GSK-923295, and would delay or prevent our ability to generate revenues.
Disputes may arise between us and GSK, which may delay or cause the termination of any GSK-923295
clinical trials, result in significant litigation or arbitration, or cause GSK to act in a manner
that is not in our best interest. If development of GSK-923295 does not progress for these or any
other reasons, we would not receive further milestone payments from GSK with respect to GSK-923295.
If GSK abandons development of GSK-923295 prior to regulatory approval or if it elects not to
proceed with commercialization of the resulting drug following regulatory approval, we would have
to seek a new partner for clinical development or commercialization, curtail or abandon that
clinical development or commercialization, or undertake and fund the clinical development of
GSK-923295 or commercialization of the resulting drug ourselves. If we seek a new partner but are
unable to do so on acceptable terms, or at all, or do not have sufficient funds to conduct that
development or commercialization ourselves, we would have to curtail or abandon that development or
commercialization, which could harm our business.
The success of our development activities depends in part on the performance of our strategic
partners, 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
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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 GSK to conduct
clinical development of GSK-923295. GSK may modify its plans to conduct that clinical
development or may not proceed diligently with that clinical development. In addition, if GSK
exercises its option with respect to either or both of ispinesib and SB-743921, or if Amgen
exercises its option with respect to CK-1827452, they will then be responsible for the clinical
development of those respective drug candidates. We do not control the clinical development being
conducted or that may be conducted in the future by GSK or Amgen, including the timing of
initiation, termination or completion of clinical trials, the analysis of data arising out of those
clinical trials or the timing of release of complete data concerning those clinical trials, which
may impact our ability to report on their results. If our partners fail to perform diligently, our
potential for revenue from drugs developed through our strategic alliances, if any, could be
dramatically reduced.
We have no manufacturing capacity and depend on our strategic 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. 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 rely on GSK to conduct these
activities for the ongoing clinical development of GSK-923295. For CK-1827452, ispinesib and
SB-743921, we rely on a limited number of contract manufacturers, and, in particular, we rely on
single-source contract manufacturers for the active pharmaceutical ingredient and the drug product
supply for our clinical trials. We expect to rely on contract manufacturers to supply all future
drug candidates for which we conduct clinical development. If any of our existing or future
contract manufacturers fail to perform as agreed, it 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. In addition, if a contract manufacturer fails to
perform as agreed, our ability to collect damages may be contractually limited.
Our drug candidates require precise, high quality manufacturing. The failure to achieve and
maintain high manufacturing standards, including failure to detect or control anticipated or
unanticipated manufacturing errors or the frequent occurrence of such errors, could result in
patient injury or death, discontinuance or delay of on-going or planned clinical trials, delays or
failures in product testing or delivery, cost overruns, product recalls or withdrawals and 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 and standards. Each contract manufacturer must pass a pre-approval inspection before
we can obtain marketing approval for any of our drug candidates and following approval will be
subject to 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 laws and standards.
We seek to ensure that our contract manufacturers comply fully with all applicable regulations,
laws and standards. However, we do not have control over our contract manufacturers compliance
with these regulations, laws and standards. If one of our contract manufacturers fails to pass its
pre-approval inspection or maintain ongoing compliance at any time, the production of our drug
candidates could be interrupted, resulting in delays or discontinuance of our clinical trials,
additional costs and potentially lost revenues. In addition, failure of any third party
manufacturers or us to comply with applicable regulations, including pre- or post-approval
inspections and
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the current good manufacturing practice requirements of the FDA or other comparable
regulatory agencies, could result in sanctions being imposed on us. These sanctions could include
fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval
of our products, delay, suspension or withdrawal of approvals, license revocation, product seizures or recalls, operational
restrictions and criminal prosecutions, any of which could significantly and adversely affect our
business.
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. If a natural disaster, business failure, strike or other
difficulty occurs, we may be unable to replace these contract manufacturers in a timely or
cost-effective manner and the production of our drug candidates would be interrupted, resulting in
delays and additional costs.
Switching manufacturers or manufacturing sites may be difficult and time-consuming because the
number of potential manufacturers is limited. In addition, before a drug from any replacement
manufacturer or manufacturing site can be commercialized, the FDA must approve that site. That
approval would require new testing and compliance inspections. A new manufacturer or manufacturing
site also would have to be educated in, or develop substantially equivalent processes for,
production of our drugs and drug candidates. It may be difficult or impossible to transfer certain
elements of a manufacturing process to a new manufacturer or for us to find a replacement
manufacturer on acceptable terms quickly, or at all, either of which would delay or prevent our
ability to develop drug candidates and commercialize any resulting drugs.
Our focus to date on the discovery and development 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.
To date, we have focused our drug discovery and development activities on the cytoskeleton,
including in the areas of muscle biology and oncology. 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 proteins and
the pathways that our drug candidates seek to modulate. As a result, we cannot be certain that our
drug candidates and potential drug candidates will appropriately modulate the targeted proteins and
pathways or produce commercially viable drugs that safely and effectively treat heart failure,
cancer 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 a particular disease, 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 our drug candidates, we will not achieve commercial
success, which would materially harm our business.
Our success depends substantially upon our ability to obtain and maintain intellectual property
protection relating to our drug candidates and research technologies.
We own or hold exclusive licenses to a number of U.S. and foreign patents and patent
applications directed to our drug candidates and research technologies. Our success depends on our
ability to obtain patent protection both in the United States and in other countries for our drug
candidates, their methods of manufacture and use, and our technologies. Our ability to protect our
drug candidates and technologies from unauthorized or infringing use by third parties depends
substantially on our ability to obtain and enforce our patents. If our issued patents and patent
applications, if granted, do not adequately describe, enable or otherwise provide coverage of our
technologies and drug candidates, including CK-1827452, ispinesib,
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SB-743921 and GSK-923295, we
would not be able to exclude others from developing or commercializing these drug candidates.
Furthermore, the degree of future protection of our proprietary rights is uncertain because legal
means may not adequately protect our rights or permit us to gain or keep our competitive advantage.
Due to evolving legal standards relating to the patentability, validity and enforceability of
patents covering pharmaceutical inventions and the claim scope of these patents, our ability to
enforce our existing patents and to obtain and enforce patents that may issue from any pending or
future patent applications is uncertain and involves complex legal, scientific and factual
questions. The standards which the U.S. Patent and Trademark Office (PTO) and its foreign
counterparts use to grant patents are not always applied predictably or uniformly and are subject
to change. To date, no consistent policy has emerged regarding the breadth of claims allowed in
biotechnology and pharmaceutical patents. Thus, we cannot be sure that any patents will issue from
any pending or future patent applications owned by or licensed to us. Even if patents do issue, we
cannot be sure that the claims of these patents will be held valid or enforceable by a court of
law, will provide us with any significant protection against competitive products, or will afford
us a commercial advantage over competitive products. 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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some or all of our or our licensors pending patent applications may not result in
issued patents or the issued claims may be narrower than initially anticipated; |
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our and our licensors issued patents may not provide a basis for commercially
viable drugs or therapies, or may not provide us with any competitive advantages, or
may be challenged and invalidated by third parties; |
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our or our licensors patent applications or patents may be subject to interference,
opposition or similar administrative proceedings; |
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we may not develop additional proprietary technologies or drug candidates that are
patentable; or |
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the patents of others may prevent us or our partners from discovering, developing or
commercializing our drug candidates. |
Patent protection is afforded on a country by country basis. The laws of some foreign
jurisdictions do not protect intellectual property rights to the same extent as in the United
States. Many companies have encountered significant difficulties in protecting and defending
intellectual property rights in foreign jurisdictions. Some of our development efforts are
performed in countries outside of the United States through third party contractors. We may not be
able to effectively monitor and assess intellectual property developed by these contractors;
therefore, we may not appropriately protect this intellectual property and could thus lose valuable
intellectual property rights. In addition, the legal protection afforded to inventors and owners
of intellectual property in countries outside of the United States may not be as protective of
intellectual property rights as in the United States. Therefore, we may be unable to acquire and
protect
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intellectual property developed by these contractors to the same extent as if these
development activities were being conducted in the United States. If we encounter difficulties in
protecting our intellectual property rights in foreign jurisdictions, our business prospects could
be substantially harmed.
Under our license agreement with the University of California and Stanford University, we have
obtained a license to certain United States patents and pending United States and foreign patent
applications relating to certain of our research activities. If we fail to fulfill our obligations under
this license agreement, including certain diligence obligations, this agreement may be terminated,
in which case we would no longer have a license to these patents or to future patents that may
issue from the pending applications. This may impair our ability to continue to practice the
research methods covered by the issued patents, which could harm our business. Alternatively, our
license rights may become non-exclusive, which would allow the University of California and
Stanford University to grant third parties the right to practice those patents.
We rely on intellectual property assignment agreements with our corporate partners, employees,
consultants, scientific advisors and other collaborators to grant us ownership of new intellectual
property that is developed. These agreements may not result in the effective assignment to us of
that intellectual property. As a result, our ownership of key intellectual property could be
compromised.
Changes in either the patent laws or their interpretation in the United States or other
countries may diminish the value of our intellectual property or our ability to obtain patents.
For example, the U.S. Senate is currently considering a bill that could change U.S. law regarding,
among other things, post-grant review of issued patents and the calculation of damages once patent
infringement has been determined by a court of law. If enacted into law, these provisions could
severely weaken patent protection in the United States. Recently, the PTO adopted new rules that
were to become effective on November 1, 2007, regarding processes for obtaining patents in the
United States. However, a permanent injunction preventing implementation of the new rules has been
issued. This decision is now being appealed. The new rules are numerous and complex and, if made
effective, generally are expected to make it more difficult for patent applicants to obtain
patents, especially with regard to pharmaceutical products and processes. If these rules changes
become effective, they would likely make it more difficult for us and others to obtain patent
protection in the United States for any future drug candidates.
If one or more products resulting from our drug candidates is approved for sale by the FDA and
we do not have adequate intellectual property protection for those products, competitors could
duplicate them for approval and sale in the United Sates without repeating the extensive testing
required of us or our partners to obtain FDA approval. Regardless of any patent protection, the
FDA is prohibited under current law from approving any generic version of a product for at least
five years after it has approved that product. When that period expires, or if it is altered, the
FDA could approve a generic version of our product unless we have patent protection sufficient for
us to block the manufacture, use or sale of that generic version in the United States. Without
sufficient patent protection, the applicant for a generic version of our product would only be
required to conduct a relatively inexpensive study to show that its product is bioequivalent to our
product, and would not have to repeat the clinical trials that we or our partners conducted to
demonstrate that the product is safe and effective. In the absence of adequate patent protection
in other countries, competitors may similarly be able to obtain regulatory approval in those
countries of products that duplicate our products.
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 endeavor to use reasonable efforts to protect our trade secrets, our or our 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 those individuals may not be enforceable or provide
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meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure. If
we were to pursue a claim that a third party had illegally obtained and was using our trade
secrets, it 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 competitors independently develop information 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 third party intellectual property rights, it 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 use, manufacture and sell those
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
therapeutic areas in which we are developing drug candidates and exploring for new potential drug
candidates. 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 may also be existing patents that our drug candidates may
inadvertently infringe.
Currently, we are aware of an issued U.S. patent and at least one pending U.S. patent
application assigned to Curis, Inc. (Curis), relating to certain compounds in the quinazolinone
class. Ispinesib falls into this class of compounds. The Curis U.S. patent claims a method of use
for inhibiting signaling by what is called the hedgehog pathway using certain quinazolinone
compounds. Curis also has pending applications in Europe, Japan, Australia and Canada with claims
covering certain quinazolinone compounds, compositions thereof and/or methods of their use. Two of
the Australian applications have been allowed and two of the European applications have been
granted. We have opposed the granting of certain of these patents to Curis in Europe and in
Australia. One of the European patents which we opposed was recently revoked and is no longer
valid in Europe. Curis has appealed this decision.
Curis or a third party may assert that the manufacture, use, importation or sale of ispinesib
may infringe one or more of these patents. We believe that we have valid defenses against the
issued U.S. patent owned by Curis if it were to be asserted against us. However, we cannot
guarantee that a court would find these defenses valid or that any additional oppositions would be
successful. We have not attempted to obtain a license to these patents. If we decide to seek a
license to these patents, we cannot guarantee that such a license would be available on acceptable
terms, if at all.
Other future products of ours may be impacted by patents of companies engaged in competitive
programs with significantly greater resources (such as Bayer AG, Merck & Co., Inc., Merck GmbH, Eli
Lilly and Company, Bristol-Myers Squibb, Array Biopharma Inc., ArQule, Inc., and AstraZeneca).
Further development of these products could be impacted by these patents and result in significant
legal fees.
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If a third party claims that our actions infringe on its 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, even if meritless, can be
costly and time-consuming to litigate, 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. |
If any of these events occur, it could significantly harm our business and negatively affect
our stock price.
We may become involved in disputes with our strategic partners over intellectual property
ownership, and publications by our research collaborators and clinical investigators 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 clinical investigators generally
have contractual rights to publish data arising from their work, subject to our prior review.
Publications by our research collaborators and clinical investigators relating to our research and
development programs, either with our permission or in contravention of their agreements with us,
could benefit our current or potential competitors and may impair our ability to obtain patent
protection or protect our proprietary information, which could significantly harm our business.
We may be subject to 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 these 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 significantly harm our
business. Even if we are successful in defending against these claims, litigation could result in
substantial costs and distract management.
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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 new drugs 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 continue to finance our 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.
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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.
We may not be able to successfully scale-up manufacture of our drug candidates in sufficient
quality and quantity, which would delay or prevent us from developing our drug candidates and
commercializing resulting approved drugs, if any.
To date, our drug candidates have been manufactured in small quantities for preclinical
studies and early-stage clinical trials. In order to conduct larger scale or late-stage clinical
trials for a drug candidate and
for commercialization of the resulting drug if that drug candidate is approved for sale, we
will need to manufacture it in larger quantities. We may not be able to successfully increase the
manufacturing capacity for any of our drug candidates, whether in collaboration with third-party
manufacturers or on our own, in a timely or cost-effective manner or at all. If a 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 those improvements. Significant
scale-up of manufacturing may require additional validation studies, which are costly and which the
FDA must review and approve. In addition, quality issues may arise during those scale-up
activities because of the inherent properties of a drug candidate itself or of a drug candidate in
combination with other components added during the manufacturing and packaging process or during
shipping and storage of the finished product or active pharmaceutical ingredients. If we are
unable to successfully scale-up manufacture of any of our drug candidates in sufficient quality and
quantity, the development of that drug candidate and regulatory approval or commercial launch for
any resulting drugs may be delayed or there may be a shortage in supply, which could significantly
harm our business.
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. We plan to commercialize
ourselves drugs 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, cost-effectively or at all, which could make us unable to commercialize our drugs. If
we determine not to market on our drugs on our own, we will depend on strategic alliances with
third parties, such as GSK and Amgen, which have established distribution systems and direct sales
forces to commercialize them. If we are unable to enter into such arrangements on acceptable
terms, we may not be able to successfully commercialize these drugs. To the extent that we are not
successful in commercializing any drugs ourselves or through a strategic alliance, our product
revenues and business will suffer and the price of our common stock could decrease.
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Our failure to attract and retain skilled personnel could impair our drug development and
commercialization activities.
Our business depends on the performance of our senior management and key scientific and
technical personnel. The loss of the services of any member of our senior management or key
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 identifying suitable replacements. 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, if and as our business grows, 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 activities, which would adversely affect the development of our drug candidates and
commercialization of our potential drugs and growth of our business.
Our workforce reductions in September 2008 and any future workforce and expense reductions may have
an adverse impact on our internal programs and our ability to hire and retain skilled personnel.
In September 2008, we reduced our workforce by approximately twenty-nine percent in order to
reduce expenses and to focus on research activities in our muscle biology programs and advancing
drug candidates in our clinical pipeline. These headcount reductions and the cost control measures
we have implemented may negatively affect our productivity and limit our research and development
activities. For example, as part of this strategic restructuring, we are discontinuing our early
research activities in oncology. Our future success will depend in large part upon our ability to
attract and retain highly skilled personnel. We may have difficulty retaining and attracting such
personnel as a result of a perceived risk of future workforce reductions. In light of our continued
need for funding and cost control, we may be required to implement future workforce and expense
reductions, which could further limit our research and development activities. In addition, the
implementation of any additional workforce or expense reduction programs may divert the efforts of
our management team and other key employees, which could adversely affect our business.
Risks Related To Our Industry
Our competitors may develop drugs that are less expensive, safer or more effective than ours, 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 cardiovascular diseases, cancer and other diseases for which our compounds may be
useful treatments. For example, if CK-1827452 or any other of our compounds is approved for
marketing by the FDA for heart failure, that compound could compete against current generically
available therapies, such as milrinone, dobutamine or digoxin or newer marketed drugs such as
nesiritide, as well as potentially against other novel drug candidates in development, such as
levosimendan, which is marketed by Abbott Laboratories in a number of countries outside of the
United States; istaroxamine, which is being developed by Debiopharm Group; rolofylline, which is
being developed by Merck & Co. Inc.; bucindolol, which is being developed by ARCA biopharma, Inc.;
and CD-NP, which is being developed by Nile Therapeutics, Inc. In addition, there are a number of
medical devices being developed for the potential treatment of heart failure.
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Similarly, if approved for marketing by the FDA, depending on the approved clinical
indication, our anti-cancer drug candidates such as ispinesib, SB-743921 and GSK-923295 could
compete against existing cancer treatments such as paclitaxel, docetaxel, vincristine, vinorelbine,
navelbine, ixabepilone and potentially against other novel anti-cancer drug candidates that are
currently in development such as those that are reformulated taxanes, other tubulin binding
compounds or epothilones. We are also aware that Merck & Co., Inc., Eli Lilly and Company,
Bristol-Myers Squibb, Array Biopharma Inc., ArQule, Inc. and others are conducting research and
development focused on kinesin spindle protein and other mitotic kinesins. In addition,
Bristol-Myers Squibb, Merck & Co., Inc., Novartis, Genentech, AstraZeneca, Hoffman-La Roche Ltd.,
Eisai, Inc. and other pharmaceutical and biopharmaceutical companies are developing other
approaches to inhibiting mitosis.
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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more successfully recruit 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 that our drug candidates will need to show in order to obtain regulatory
approval; or |
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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. 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 improving 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 drugs 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 a new drug application
(NDA) from the FDA. Neither we nor our partners have received marketing approval for any of
Cytokinetics drug candidates.
Obtaining NDA approval 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 and foreign regulatory agencies
also have substantial discretion in the drug approval process. Despite the time and efforts
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 approval by
the FDA and foreign regulatory agencies 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 and foreign regulatory agencies can delay, limit or deny
approval of a drug candidate for many reasons, including, but not limited to:
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they might determine that a drug candidate is not be safe or effective; |
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they might not find the data from preclinical testing and clinical trials
sufficient; |
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they might not approve our or our contract manufacturers processes or facilities;
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they might change their approval policies or adopt new regulations. |
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Even if we receive regulatory approval to manufacture and sell a drug in a particular
regulatory jurisdiction, other jurisdictions regulatory authorities may not approve that drug for
manufacture and sale. If we or our partners fail to receive and maintain regulatory approval for
the sale of any drugs resulting from our drug candidates, it would significantly harm our business
and negatively affect our stock price.
If we or our partners receive regulatory approval for our drug candidates, we will also be subject
to ongoing obligations to and continued regulatory review by the FDA and foreign regulatory
agencies, such as continued safety reporting requirements, and we may also be subject to additional
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 require
potentially costly post-marketing follow-up studies. In addition, if the FDA or foreign regulatory
agencies 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 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 or withdrawal of the drug from the market.
The policies of the FDA and foreign regulatory agencies 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 would 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, the 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; or |
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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.
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.
Even if one or more of our drugs is approved for sale, the commercial success of our drugs in
both domestic and international markets will be substantially dependent on whether third-party
coverage and reimbursement is available for our drugs by the medical profession for use by their
patients, which is highly uncertain. 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 drugs. They may not view our drugs as cost-effective and
reimbursement may not be available to consumers or may be insufficient to allow our drugs to be
marketed on a competitive basis. If we are unable to obtain adequate coverage and reimbursement
for our 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 or other liability claims and may not be able to
obtain adequate insurance.
The use of our drug candidates in clinical trials may result in adverse effects. We currently
maintain product liability insurance. We cannot predict all the possible harms or adverse effects
that may result from our clinical trials. We may not have sufficient resources to pay for any
liabilities resulting from a personal injury or other claim excluded from, or beyond the limit of,
our insurance coverage. Our insurance does not cover third parties negligence or malpractice, and
our clinical investigators and sites may have inadequate insurance or none at all. In addition, in
order to conduct clinical trials or otherwise carry out our business, we may have to contractually
assume liabilities for which we may not be insured. If we are unable to look to our own or a third
partys insurance to pay claims against us, we may have to pay any arising costs and damages
ourselves, which may be substantial.
In addition, if we commercially launch drugs based on our drug candidates, we will face even
greater exposure to product liability claims. This risk exists even with respect to those drugs
that are approved for commercial sale by the FDA and foreign regulatory agencies and manufactured
in licensed and regulated facilities. 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 are 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 and foreign regulatory agencies, other governmental agencies or other
companies having
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regulatory control for drug sales. If product recalls occur, they are generally
expensive and often have an adverse effect on the reputation of the drugs being recalled and of the
drugs developer or manufacturer.
Responding to any claims relating to improper handling, storage or disposal of the hazardous
chemicals and radioactive and biological materials we use in our business 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 activities.
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 damages and
other liabilities arising out of our development activities or drugs produced in connection with
these strategic alliances, which could be costly and time-consuming and distract management.
Our facilities in California are located near an earthquake fault, and an earthquake or other types
of natural disasters, catastrophic events or resource shortages could disrupt our operations and
adversely affect our results.
All of our facilities and our important documents and records, such as hard copies of our
laboratory books and records for our drug candidates and compounds and our electronic business
records, 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
or flood, a catastrophic event such as a disease pandemic or terrorist attack 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. Our partners and other third parties on which we rely may also be subject to
business interruptions from such events. 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 at or above your investment price.
The stock market, particularly in recent months and years, has experienced significant
volatility, particularly with respect to pharmaceutical, biotechnology and other life sciences
company stocks, which 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:
-22-
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results from, delays in, or discontinuation of, any of the clinical trials for our
drug candidates for the potential treatment of heart failure or cancer, including the
current and proposed clinical trials for CK-1827452 for heart failure, ispinesib for
breast cancer and leukemia, SB-743921 for Hodgkin and non-Hodgkin lymphoma, and
GSK-923295 for cancer, and including delays resulting from slower than expected or suspended patient enrollment or discontinuations
resulting from a failure to meet pre-defined clinical end-points; |
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announcements concerning our strategic alliances with Amgen, GSK or future strategic
alliances, including, but not limited to, announcements concerning Amgens option
relating to CK-1827452 and GSKs option relating to either or both of ispinesib and
SB-743921; |
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announcements concerning clinical trials; |
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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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issuance of new or changed securities analysts reports or recommendations; |
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failure or delay in establishing new strategic alliances, or the terms of those
alliances; |
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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; or |
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volatility in the stock prices of other companies in our industry or in the stock
market generally. |
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.
-23-
Our
common stock is listed for quotation on the NASDAQ Global Market (NASDAQ). To keep our
listing, we must meet NASDAQs listing maintenance standards. If we are unable to continue to meet
NASDAQs listing maintenance standards, our common stock could be delisted and would need to be
traded in the non-NASDAQ, over-the-counter market. If our common stock were delisted, it may be more
difficult to trade, or get an accurate market value of, our common stock. This could severely limit
our stockholders ability to sell our common stock in the secondary market. A delisting would also
make it more difficult for us to raise funds through the sale of our securities.
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 October 31, 2008, our executive officers, directors and their affiliates beneficially
owned or controlled approximately 25.4% 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.
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
(SEC) regulations and NASDAQ Stock Market LLC 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 these costs. For example, compliance with the internal control requirements of
Section 404 of the Sarbanes-Oxley Act has to date required the commitment of significant resources
to document and test the adequacy of our internal control over financial reporting. While our
assessment, testing and evaluation of the design and operating effectiveness of our internal
control over financial reporting resulted in our conclusion that, as of December 31, 2007, our
internal control over financial reporting was effective, 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 in the future. 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, which could be costly and time-consuming, and our reputation
and business may be harmed.
-24-
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, and could
harm our reputation and business.
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.
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 Our Financing Vehicles and Investments
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 2007, we entered into a committed equity financing facility with Kingsbridge. This
committed equity financing facility 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 $75.0 million, subject to certain conditions and restrictions. Kingsbridge will not
be obligated to purchase shares under this committed equity financing facility 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 the
registration statement registering for resale the shares of common stock to be issued in connection
with this committed equity financing facility; and the continued listing of our stock on NASDAQ. In
addition, Kingsbridge is permitted to terminate this committed equity financing facility 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 this committed equity financing facility, or if Kingsbridge terminates this committed
equity financing facility, we may be unable to access capital on favorable terms or at all.
-25-
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 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
registration statement, the blackout or other payment could be significant.
Should we sell shares to Kingsbridge under this committed equity financing facility, 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 this committed equity financing facility, 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 this committed equity financing facility 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.
We may be required to record impairment charges in future quarters as a result of the decline in
value of our investments in auction rate securities.
We hold interest-bearing student loan auction rate securities (ARS) that represent
investments in pools of assets. These ARS were intended to provide liquidity via an auction process
that resets the applicable interest rate at predetermined calendar intervals, allowing investors to
either roll over their holdings or gain immediate liquidity by selling such interests at par. The
recent uncertainties in the credit markets have affected all of our holdings in ARS and auctions
for our investments in these securities have failed to settle on their respective settlement dates.
Consequently, these investments are not currently liquid and we will not be able to access these
funds until a future auction of these investments is successful, the issuer redeems the outstanding
securities, the securities mature or a buyer is found outside of the auction process. Maturity
dates for these ARS range from 2036 to 2045. To date, we have recorded $1.8 million of unrealized
loss in other comprehensive income (loss) related to the ARS that we hold in our investment
portfolio. However, if the current market conditions deteriorate further, or the anticipated
recovery in market values does not occur, we may be required to record additional unrealized losses
in other comprehensive income (loss) or impairment charges in future quarters. This could adversely
impact our results of operations and financial condition. Furthermore, in light of auction failures
associated with our ARS, we re-classified our ARS as long-term investments due to the uncertainty
associated with the timing of our ability to access the funds underlying these investments. If we
are unable to access the funds underlying or secured by these ARS in a timely manner, we may need
to find alternate sources of funding for certain of our operations, which may not be available on
favorable terms, or at all, and our business could be adversely effected.
-26-
We may not be able to recover the value of our ARS under our settlement agreement with UBS AG.
We have entered into a settlement agreement with UBS AG with respect to ARS sold to us by UBS
AG and its affiliates, through which UBS AG and its affiliates may provide us with additional funds
based on these ARS. Under this settlement, UBS AG will issue to Cytokinetics Series C-2 Auction
Rate Securities Rights (the ARS Rights). The ARS Rights will entitle us to require UBS AG to
purchase our ARS, through UBS Securities LLC and UBS Financial Services Inc. (the UBS Entities)
as agents for UBS AG, from June 30, 2010 through July 2, 2012 (the Exercise Period) at a price
equal to the liquidation preference of the ARS plus accrued but unpaid interest, if any (par
value). In connection with the ARS Rights, we granted to the UBS Entities the right to sell or
otherwise dispose of, and/or enter orders in the auction process with respect to, our ARS on our
behalf at its discretion, so long as we receive a payment of par value upon any sale or
disposition. The ARS Rights are not transferable, tradable or marginable, and will not be listed or
quoted on any securities exchange or any electronic communications network. If our ARS are sold
through the UBS Entities, we will cease to receive interest or dividends on these ARS. We may not
be able to reinvest the cash proceeds of any sale of these ARS at the same interest rate or
dividend yield currently being paid to us with respect to our ARS.
While we entered into the settlement in expectation that UBS AG will fulfill its obligations
in connection with the ARS Rights, UBS AG may not have sufficient financial resources to satisfy
these obligations. The United States and worldwide financial markets have recently experienced
unprecedented volatility, particularly in the financial services sector. While UBS AG has stated
that it believes it has the financial resources necessary to perform its obligations under the ARS
Rights, UBS AG may not be able to maintain the financial resources during the course of the
Exercise Period necessary to satisfy its obligations with respect to the ARS Rights in a timely
manner or at all. The obligations of UBS AG under the ARS Rights are not secured by the assets of
UBS AG or otherwise and are not guaranteed by any other entity. UBS AG is not required to obtain
any financing to support its obligations. If UBS AG is unable to perform its obligations under the
settlement, we will no longer have the certainty as to the liquidity or value for our ARS. In
addition, UBS AG is a Swiss bank and all or a substantial portion of its assets are located outside
the United States. Accordingly, it may be difficult for us to serve legal process on UBS AG or its
management or have any of them appear in a U.S. court. Judgments based solely on the U.S.
securities laws may not be enforceable in Switzerland. As a result, if UBS AG fails to fulfill its
obligations, we may not be able to effectively seek recourse against it.
As
part of the settlement, and if we so request, UBS Bank USA or an
affiliate (collectively, UBS Bank) will establish a
credit line in an amount up to 75% of the market value of the ARS
that we pledge as collateral, subject to our entering into a Credit
Agreement with UBS Bank and meeting certain other requirements. We
have not determined if or when we will avail ourselves of this credit
line. This credit line may not be available to us on favorable terms
or funds under this credit line may not be available to us when
needed, either of which would adversely affect our business.
In consideration for the settlement, we agreed to release UBS AG, the UBS Entities, and/or
their affiliates, directors, and officers from any claims directly or indirectly relating to the
marketing and sale of our ARS, other than consequential damages. Even if UBS AG fails to fulfill
its obligations in connection with the settlement, this release may still be held to be
enforceable.
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.
-27-
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 within the meaning of the Private Securities Reform Act of 1995 that are
based upon current expectations. It is our intent that such statements be protected by the safe
harbor created thereby.
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 cytoskeletal focus; |
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our plans or ability to commercialize drugs, with or without a partner; |
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losses, costs and expenditures; |
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the scope and size of operations; |
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potential competitors and competitive products; |
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sufficiency of capital resources and our needs for additional financing; |
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expected future sources of revenue and capital; |
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our ability to defend against intellectual property infringement claims; |
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increasing the number of our employees and recruiting additional key personnel; |
-28-
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fluctuations in our stock price; |
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reliance on contractors; and |
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use of proceeds. |
In addition, the words anticipates, believes, estimates, expects, intends, may,
plans, projects, will, would and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain these identifying
words. We may not actually achieve the plans, intentions or expectations disclosed in our
forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in the forward-looking statements
that we make. We have included important factors in the cautionary statements included in this
prospectus and the documents incorporated by reference in this prospectus, particularly in the
sections entitled Risk Factors, that we believe could cause actual results or events to differ
materially from the forward-looking statements that we make. Our forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or
investments we may make. We do not assume any obligation to update any forward-looking statements.
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 research and development, 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 and government backed
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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Nine Months Ended |
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Fiscal Year Ended December 31, |
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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 stock
dividends(1) |
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Due to our losses in years ended December 31, 2003, 2004, 2005, 2006 and 2007 and the nine
months ended September 30, 2008, the ratio coverage was less than 1:1. Additional earnings of
$32.7 million, $37.2 million, $42.3 million, $57.1 million, $48.9 million and $45.5 million
would have been required in each of those periods, respectively, to achieve a coverage of 1:1. |
-29-
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; 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
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 180,000,000
shares. Those shares consist of 170,000,000 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 October 31, 2008, there were 49,444,563
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 Global Market under the symbol CYTK. The transfer
agent and registrar for our common stock is BNY Mellon Investor Services LLC. Mellons address is
525 Market Street, Suite 3500, San Francisco, California 94105 and its telephone number is (415)
951-4188.
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.
-30-
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. Our 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.
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 those dividends will be payable (or the method
by which those 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 United States, the currency or currencies
(including composite currencies) in which the 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 that series of preferred stock may be
calculated and any commodities, currencies or indices, or value, rate or price,
relevant to that 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 those
conversions will be effected; |
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the place or places where dividends and other payments on that 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. |
-31-
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
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 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.
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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
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.
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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 any other events specified in the applicable prospectus
supplement.
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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 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 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 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 that
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 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 Global Market may engage in passive market making transactions in the securities on the NASDAQ Global 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 the 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.
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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 and managements assessment of the effectiveness of internal control
over financial reporting (which is included in Managements Report on Internal Control over
Financial Reporting) incorporated in this prospectus by reference to the Annual Report on Form 10-K
for the year ended December 31, 2007 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 100 F Street, N.E., 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, 2007; |
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our definitive proxy statement on Schedule 14A, filed on April 2, 2008; |
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our quarterly reports on Form 10-Q for the fiscal quarters ended March 31, 2008,
June 30, 2008 and September 30, 2008; |
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our current reports on Form 8-K dated January 31, 2008, March 4, 2008, March 24,
2008, March 31, 2008, April 2, 2008, April 16, 2008, April 17, 2008, April 29, 2008,
May 16, 2008, May 29, 2008, June 3, 2008, June 13, 2008, June 16, 2008, June 20, 2008,
June 25, 2008, June 30, 2008, July 31, 2008, August 27, 2008, September 2, 2008,
September 5, 2008, September 8, 2008, September 16, 2008, September 24, 2008, October
20, 2008, October 23, 2008, October 30, 2008, and
November 10, 2008; 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 those
exhibits are specifically incorporated by reference, are available from us without charge, upon
oral or written request to:
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, California 94080
United States of America
Attn: Investor Relations
(650) 624-3000
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5,300,000 Shares of Common Stock
8,070 Shares of Series A Convertible Preferred Stock
Warrants to Purchase 6,685,000 Shares of Common Stock
April 18, 2011