e424b5
Filed Pursuant to
Rule 424(b)5
Registration
Statement
No. 333-159279
Prospectus
Supplement
(to Prospectus dated June 5, 2009)
3,500,000 Shares
Common
Stock
We are offering 3,500,000 shares of our common stock. Our
common stock is quoted on The NASDAQ Global Market under the
symbol RDEA. The last reported sale price of our
common stock on The NASDAQ Global Market on April 5, 2010
was $21.76 per share.
Investing in our common stock involves a high degree of risk.
Please read Risk Factors beginning on
page S-3
of this prospectus supplement and in the documents incorporated
by reference into this prospectus supplement.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus supplement or the
accompanying prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
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PER SHARE
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TOTAL
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Public Offering Price
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$
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20.00
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$
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70,000,000
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Underwriting Discounts and Commissions
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$
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0.85
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$
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2,975,000
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Proceeds to Ardea (Before Expenses)
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$
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19.15
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$
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67,025,000
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Delivery of the shares of common stock is expected to be made on
or about April 9, 2010. We have granted the underwriters an
option for a period of 30 days to purchase up to an
additional 525,000 shares of our common stock solely to
cover overallotments. If the underwriters exercise the option in
full, the total underwriting discounts and commissions payable
by us will be $3,421,250 and the total proceeds to us, before
expenses, will be $77,078,750.
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Sole
Book-Running Manager
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Joint
Lead Manager
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Jefferies &
Company
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Oppenheimer & Co.
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Prospectus Supplement dated
April 6, 2010
Table of
Contents
Prospectus
Supplement
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Page
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S-ii
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S-1
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S-3
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S-4
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S-5
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S-6
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S-7
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S-10
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S-12
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S-12
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S-12
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S-12
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Prospectus
You should rely only on the information contained in or
incorporated by reference in this prospectus supplement, the
accompanying prospectus and in any free writing prospectus that
we have authorized for use in connection with this offering. We
have not, and the underwriters have not, authorized anyone to
provide you with different information. If anyone provides you
with different or inconsistent information, you should not rely
on it. We are not, and the underwriters are not, making an offer
to sell these securities in any jurisdiction where the offer or
sale is not permitted. You should assume that the information
appearing in this prospectus supplement, the accompanying
prospectus, the documents incorporated by reference in this
prospectus supplement and the accompanying prospectus, and in
any free writing prospectus that we have authorized for use in
connection with this offering, is accurate only as of the date
of those respective documents. Our business, financial
condition, results of operations and prospects may have changed
since those dates. You should read this prospectus supplement,
the accompanying prospectus, the documents incorporated by
reference in this prospectus supplement and the accompanying
prospectus, and any free writing prospectus that we have
authorized for use in connection with this offering, in their
entirety before making an investment decision. You should also
read and consider the information in the documents to which we
have referred you in the sections of this prospectus supplement
entitled Where You Can Find More Information and
Incorporation of Certain Information by Reference.
S-i
About this
Prospectus Supplement
This document is in two parts. The first part is this prospectus
supplement, which describes the terms of this offering of common
stock and also adds to and updates information contained in the
accompanying prospectus and the documents incorporated by
reference into this prospectus supplement and the accompanying
prospectus. The second part, the accompanying prospectus dated
June 5, 2009, including the documents incorporated by
reference therein, provides more general information. Generally,
when we refer to this prospectus, we are referring to both parts
of this document combined. To the extent there is a conflict
between the information contained in this prospectus supplement,
on the one hand, and the information contained in the
accompanying prospectus or in any document incorporated by
reference that was filed with the Securities and Exchange
Commission, or SEC, before the date of this prospectus
supplement, on the other hand, you should rely on the
information in this prospectus supplement. If any statement in
one of these documents is inconsistent with a statement in
another document having a later date for example, a
document incorporated by reference in the accompanying
prospectus the statement in the document having the
later date modifies or supersedes the earlier statement.
This prospectus supplement and the accompanying prospectus dated
June 5, 2009 are part of a registration statement on
Form S-3
(File
No. 333-159279)
we filed with the SEC using a shelf registration
process. Under this shelf registration process, we
may sell from time to time in one or more offerings up to
$75,000,000 of shares of our common stock described in the
accompanying prospectus and up to an additional $5,500,000 of
shares of our common stock registered under a related
registration statement (File
No. 333-165909)
we filed pursuant to Rule 462(b) under the Securities Act
of 1933, as amended, or the Securities Act. We collectively
refer to these registration statements on
Form S-3
herein as the registration statement.
All references in this prospectus supplement and the
accompanying prospectus to Ardea, RDEA,
the Company, we, us,
our, or similar references refer to Ardea
Biosciences, Inc. and its wholly-owned subsidiary, except where
the context otherwise requires or as otherwise indicated.
This prospectus supplement, the accompanying prospectus, and the
information incorporated herein and therein by reference,
include trademarks, service marks and trade names owned by us or
other companies. All trademarks, service marks and trade names
included or incorporated by reference into this prospectus
supplement or the accompanying prospectus are the property of
their respective owners.
S-ii
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 and
the accompanying prospectus. 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. For a
more complete understanding of our company and this offering, we
encourage you to 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,
and the information included in any free writing prospectus that
we have authorized for use in connection with this offering,
including the information referred to under the heading
Risk Factors in this prospectus supplement beginning
on
page S-3.
Company
Overview
We are a biotechnology company focused on the development of
small-molecule therapeutics for the treatment of gout, cancer
and human immunodeficiency virus, or HIV. The current status of
our development programs is as follows:
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Product
Candidate
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Target
Indication
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Development
Status
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RDEA594
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Gout
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Phase 2b ongoing
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RDEA684
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Gout
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Preclinical development ongoing
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RDEA119
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Cancer
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Phase 1 and Phase 1/2 ongoing
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RDEA806
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HIV
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Phase 2a completed
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RDEA427
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HIV
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Phase 0* completed
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* |
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First-in-human
micro-dose pharmacokinetic study in normal healthy volunteers. |
Corporate
Information
We were incorporated in the State of Delaware in January 1994.
Our corporate offices are located at 4939 Directors Place,
San Diego, CA 92121. Our telephone number is
(858) 652-6500.
Our website address is www.ardeabio.com. The information
contained in, or that can be accessed through, our website is
not part of, and is not incorporated into, this prospectus
supplement or the accompanying prospectus and should not be
considered part of this prospectus supplement or the
accompanying prospectus.
S-1
The
Offering
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Common stock offered by us
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3,500,000 shares
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Common stock to be outstanding immediately after this offering
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22,124,236 shares
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Use of
Proceeds
We intend to use the net proceeds from this offering for general
corporate purposes, including clinical trial expenses, research
and development expenses and general and administrative
expenses, including working capital. We may also use a portion
of the net proceeds to in-license, invest in or acquire
businesses or technologies that we believe are complementary to
our own, although we have no current plans, commitments or
agreements to do so as of the date of this prospectus
supplement. Pending these uses, we intend to invest the net
proceeds in investment-grade, interest-bearing securities. See
Use of Proceeds on
page S-5
of this prospectus supplement.
NASDAQ Global
Market Listing
Our common stock is listed on The NASDAQ Global Market under the
symbol RDEA.
Risk
Factors
Investing in our common stock involves a high degree of risk.
See Risk Factors on
page S-3
of this prospectus supplement.
Outstanding
Shares
The number of shares of our common stock to be outstanding
immediately after this offering is based on
18,624,236 shares outstanding as of March 31, 2010,
and excludes as of such date:
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3,386,788 shares of common stock issuable upon the exercise
of outstanding options, at a weighted average exercise price of
approximately $11.18 per share;
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719,338 shares of common stock issuable upon the exercise
of outstanding warrants, at a weighted average exercise price of
approximately $11.01 per share; and
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2,097,370 shares of common stock available for future grant
under our 2002 Non-Officer Equity Incentive Plan, as amended,
2000 Employee Stock Purchase Plan, and Amended and Restated 2004
Stock Incentive Plan.
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Except as otherwise indicated, all information in the prospectus
supplement assumes no exercise by the underwriters of their
overallotment option.
S-2
Risk
Factors
An investment in our common stock involves a high degree of
risk. Before deciding whether to invest in our common stock, you
should consider carefully the risks described below and
discussed under the section captioned Risk Factors
contained in our Annual Report on
Form 10-K
for the year ended December 31, 2009, as filed with the SEC
on March 12, 2010, which are incorporated by reference in
this prospectus supplement and the accompanying prospectus in
their entirety, together with other information in this
prospectus supplement, the accompanying prospectus, the
information and documents incorporated by reference, and in any
free writing prospectus that we have authorized for use in
connection with this offering. If any of these risks actually
occurs, our business, financial condition, results of operations
or cash flow could be seriously harmed. This could cause the
trading price of our common stock to decline, resulting in a
loss of all or part of your investment.
Risks Related to
This Offering
Management will have broad discretion as to the use of the
proceeds from this offering, and we may not use the proceeds
effectively.
Our management will have broad discretion in the application of
the net proceeds from this offering and could spend the proceeds
in ways that do not improve our results of operations or enhance
the value of our common stock. Our failure to apply these funds
effectively could have a material adverse effect on our business
or the development of our product candidates and cause the price
of our common stock to decline.
You will experience immediate and substantial dilution in the
net tangible book value per share of the common stock you
purchase.
Since 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. Based on the public offering price of $20.00 per
share, if you purchase shares of common stock in this offering,
you will suffer immediate and substantial dilution of $15.85 per
share in the net tangible book value of the common stock. See
the section entitled Dilution in this prospectus
supplement for a more detailed discussion of the dilution you
will incur if you purchase common stock in this offering.
You may experience future dilution as a result of future
equity offerings or other equity issuances.
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. 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 March 31, 2010, 2,097,370 shares of common stock
were reserved and available for future grant under our 2002
Non-Officer Equity Incentive Plan, as amended, 2000 Employee
Stock Purchase Plan, and Amended and Restated 2004 Stock
Incentive Plan. Also as of such date, options to purchase
3,386,788 shares of our common stock and warrants to
purchase 719,338 shares of our common stock were
outstanding . You will incur dilution upon the grant of any
shares pursuant to any of such plans, upon vesting of any stock
awards under any of such plans, or upon exercise of any such
outstanding options or warrants.
S-3
Special Note
Regarding Forward-Looking Statements
This prospectus supplement, the accompanying prospectus, the
documents we have filed with the SEC that are incorporated by
reference and any free writing prospectus that we have
authorized for use in connection with this offering contain
forward-looking statements within the meaning of
Section 27A of the Securities Act, and Section 21E of
the Securities Exchange Act of 1934, as amended, or the Exchange
Act. These statements relate to future events or to our future
operating or financial performance and involve known and unknown
risks, uncertainties and other factors which may cause our
actual results, performance or achievements to be materially
different from any future results, performances or achievements
expressed or implied by the forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements about:
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the safety and efficacy of our product candidates;
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the progress, timing and results of clinical trials and research
and development efforts involving our product candidates;
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the submission of applications for and receipt of regulatory
clearances and approvals;
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our expectations with regard to our intellectual property
position and our ability to successfully protect our
intellectual property;
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our plans to conduct future clinical trials or research and
development efforts;
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estimates of the potential markets for our product candidates;
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our operating and growth strategies, industry, planned products,
and our expected future revenues, operations and expenditures
and projected cash needs;
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our expectations about partnering, acquisitions, licensing and
marketing;
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the use of proceeds from this offering; and
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economic conditions, both generally and those specifically
related to the biotechnology industry.
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In some cases, you can identify forward-looking statements by
terms such as may, will,
should, could, would,
expects, plans, anticipates,
believes, estimates,
projects, predicts,
potential and similar expressions intended to
identify forward-looking statements. These statements reflect
our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. We discuss many of these risks in
greater detail under the heading Risk Factors
beginning on
page S-3
of this prospectus supplement and in our SEC filings. Also,
these forward-looking statements represent our estimates and
assumptions only as of the date of the document containing the
applicable statement.
You should read this prospectus supplement, the accompanying
prospectus, the documents we have filed with the SEC that are
incorporated by reference and any free writing prospectus that
we have authorized for use in connection with this offering
completely and with the understanding that our actual future
results may be materially different from what we expect. We
qualify all of the forward-looking statements in the foregoing
documents by these cautionary statements.
You should rely only on the information contained, or
incorporated by reference, in this prospectus supplement, the
accompanying prospectus and any free writing prospectus that we
have authorized for use in connection with this offering. We and
the underwriters for this offering have not authorized anyone to
provide you with different information. The common stock offered
under this prospectus is not being offered in any state where
the offer is not permitted. You should not assume that the
information contained in this prospectus supplement or the
accompanying prospectus is accurate as of any date other than
the date on the front of this prospectus supplement or the
accompanying prospectus, as applicable, or that any information
incorporated by reference in this prospectus supplement or the
accompanying prospectus is accurate as of any date other than
the date of the document so incorporated by reference. Unless
required by law, we undertake no obligation to update or revise
any forward-looking statements to reflect new information or
future events or developments. Thus, you should not assume that
our silence over time means that actual events are bearing out
as expressed or implied in such forward-looking statements.
S-4
Use of
Proceeds
We estimate that the net proceeds from the sale of the
3,500,000 shares of common stock that we are offering will
be approximately $66.8 million, or approximately
$76.9 million if the underwriters exercise in full their
option to purchase 525,000 additional shares of common stock,
based on the public offering price of $20.00 per share and after
deducting the underwriting discounts and commissions and
estimated offering expenses payable by us.
We intend to use the net proceeds from this offering for general
corporate purposes, including clinical trial expenses, research
and development expenses and general and administrative
expenses, including working capital. We may also use a portion
of the net proceeds to in-license, invest in or acquire
businesses or technologies that we believe are complementary to
our own, although we have no current plans, commitments or
agreements to do so as of the date of this prospectus supplement.
The amounts and timing of these expenditures will depend on a
number of factors, such as the timing, scope, progress and
results of our research and development efforts, the timing and
progress of any partnering efforts, and the competitive
environment for our product candidates. As of the date of this
prospectus supplement, we cannot specify with certainty all of
the particular uses of the proceeds from this offering.
Accordingly, we will retain broad discretion over the use of
such proceeds. Pending the use of the net proceeds from this
offering as described above, we intend to invest the net
proceeds in interest-bearing, investment-grade securities.
S-5
Dilution
Our net tangible book value as of December 31, 2009 was
approximately $24.5 million, or $1.32 per share. Net
tangible book value per share is determined by dividing our
total tangible assets, less total liabilities, by the number of
shares of our common stock outstanding as of December 31,
2009. Dilution in net tangible book value per share represents
the difference between the amount per share paid by purchasers
of shares of common stock in this offering and the net tangible
book value per share of our common stock immediately after this
offering.
After giving effect to the sale of 3,500,000 shares of our
common stock in this offering at the public offering price of
$20.00 per share and after deducting the underwriting discounts
and commissions and estimated offering expenses payable by us,
our as adjusted net tangible book value as of December 31,
2009 would have been approximately $91.3 million, or $4.15
per share. This represents an immediate increase in net tangible
book value of $2.83 per share to existing stockholders and
immediate dilution in net tangible book value of $15.85 per
share to new investors purchasing our common stock in this
offering. The following table illustrates this dilution on a per
share basis:
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Public offering price per share
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$
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20.00
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Net tangible book value per share as of December 31, 2009
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$
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1.32
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Increase per share attributable to new investors
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$
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2.83
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As adjusted net tangible book value per share after this offering
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$
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4.15
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Dilution per share to new investors
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$
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15.85
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If the underwriters exercise in full their option to purchase
525,000 additional shares of common stock at the public offering
price of $20.00 per share, the as adjusted net tangible book
value after this offering would be $4.50 per share, representing
an increase in net tangible book value of $3.18 per share to
existing stockholders and immediate dilution in net tangible
book value of $15.50 per share to new investors purchasing our
common stock in this offering.
The above discussion and table are based on
18,504,898 shares outstanding as of December 31, 2009,
and exclude as of such date:
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3,391,795 shares of common stock issuable upon the exercise
of outstanding options, at a weighted average exercise price of
approximately $10.84 per share;
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719,338 shares of common stock issuable upon the exercise
of outstanding warrants, at a weighted average exercise price of
approximately $11.01 per share; and
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1,286,456 shares of common stock available for future grant
under our 2002 Non-Officer Equity Incentive Plan, as amended,
2000 Employee Stock Purchase Plan, and Amended and Restated 2004
Stock Incentive Plan.
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To the extent that outstanding options or warrants are
exercised, investors purchasing 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-6
Underwriting
Under the terms and subject to the conditions contained in an
underwriting agreement dated April 6, 2010 by and among us
and the underwriters named below, for whom Jefferies &
Company, Inc. is acting as representative, the underwriters have
agreed to purchase, and we have agreed to sell to them, the
number of shares of common stock indicated in the table below:
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Number
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Name
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of
Shares
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Jefferies & Company, Inc.
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2,450,000
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Oppenheimer & Co. Inc.
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1,050,000
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Total
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3,500,000
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The underwriters are offering the common stock subject to their
acceptance of the shares from us and subject to prior sale. The
underwriting agreement provides that the obligations of the
underwriters to pay for and accept delivery of the common stock
offered by this prospectus supplement are subject to the
approval of certain legal matters by their counsel and to
certain other conditions. The underwriting agreement provides
that the underwriters are obligated to take and pay for all of
the common stock if any such shares are purchased, other than
those shares covered by the overallotment option described below.
Commissions and
Expenses
The underwriters have advised us that they propose to offer the
shares to the public at the public offering price set forth on
the cover page of this prospectus supplement and to certain
dealers at that price less a concession not in excess of $0.51
per share. After the offering, the public offering price and
concession to dealers may be reduced by the underwriters. No
such reduction shall change the amount of proceeds to be
received by us as set forth on the cover page of this prospectus
supplement. The shares are offered by the underwriters as stated
herein, subject to receipt and acceptance by them and subject to
their right to reject any order in whole or in part.
The following table shows the public offering price, the
underwriting discounts and commissions payable to the
underwriters by us and the proceeds, before expenses, to us.
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Total Without
Exercise
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Total With
Full
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of
Overallotment
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Exercise of
Overallotment
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Per
Share
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Option
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Option
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Public offering price
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$
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20.00
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$
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70,000,000
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$
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80,500,000
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Underwriting discounts and commissions
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$
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0.85
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$
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2,975,000
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$
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3,421,250
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Proceeds to Ardea (before expenses)
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$
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19.15
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$
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67,025,000
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$
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77,078,750
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We estimate expenses payable by us in connection with the
offering of common stock, other than the underwriting discounts
and commissions referred to above, will be approximately
$220,000.
Option to
Purchase Additional Shares
We have granted to the underwriters an option, exercisable for
30 days from the date of this prospectus supplement, to
purchase up to an aggregate of 525,000 additional shares at the
same price they are paying for the shares shown in the table
above. The underwriters may exercise this option at any time and
from time to time, in whole or in part, within 30 days
after the date of this prospectus supplement. If the
underwriters exercise the option in full, the total underwriting
discounts and commissions payable by us will be $3,421,250 and
the total proceeds to us, before expenses, will be $77,078,750.
S-7
Indemnification
We have agreed to indemnify the underwriters against certain
liabilities, including liabilities under the Securities Act. We
have also agreed to contribute to payments that the underwriters
may be required to make in respect of those liabilities.
Lock-up
Agreements
Our executive officers and directors have agreed, subject to
specified exceptions, not to directly or indirectly sell, offer,
contract or grant any option to sell (including without
limitation any short sale), pledge, transfer, establish an open
put equivalent position within the meaning of
Rule 16a-1(h)
under the Exchange Act or otherwise dispose of any shares of our
common stock, options or warrants to acquire shares of our
common stock, or securities exchangeable or exercisable for or
convertible into shares of our common stock currently or
hereafter owned either of record or beneficially (as defined in
Rule 13d-3
under the Exchange Act) by such person, or publicly announce an
intention to do any of the foregoing. We have also agreed,
subject to specified exceptions, not to directly or indirectly
sell (including, without limitation, any short sale), offer,
contract or grant any option to sell, pledge, transfer or
establish an open put equivalent position within the
meaning of
Rule 16a-1(h)
under the Exchange Act, or otherwise dispose of or transfer, or
announce the offering of, or file any registration statement
under the Securities Act in respect of, any shares of our common
stock, options, rights or warrants to acquire shares of our
common stock, or securities exchangeable or exercisable for or
convertible into shares of common stock, or publicly announce
the intention to do any of the foregoing.
These restrictions terminate after the close of trading of the
shares on and including the 90th day after the date of this
prospectus supplement. Jefferies & Company, Inc. may,
in its sole discretion and at any time or from time to time
before the termination of the
90-day
period, without notice, release all or any portion of the
securities subject to
lock-up
agreements. However, subject to specified exceptions, if
(i) during the last 17 days of the
90-day
period, the Company issues an earnings release or material news
or a material event relating to the Company occurs or
(ii) prior to the expiration of the
90-day
period, the Company announces that it will release earnings
results during the
16-day
period beginning on the last day of the
90-day
period, then in each case the
90-day
period will be extended until the expiration of the
18-day
period beginning on the date of the issuance of the earnings
release or the occurrence of the material news or material
event, as applicable, unless Jefferies & Company, Inc.
waives, in writing, such extension.
Electronic
Distribution
This prospectus supplement and the accompanying prospectus in
electronic format may be made available on websites or through
other online services maintained by the underwriters of the
offering, or by their affiliates. Other than the prospectus in
electronic format, the information on the underwriters
websites and any information contained in any other website
maintained by the underwriters is not part of the prospectus or
the registration statement of which this prospectus supplement
forms a part, has not been approved
and/or
endorsed by us or the underwriters in their capacity as
underwriters and should not be relied upon by investors.
Price
Stabilization, Short Positions and Penalty Bids
Until the distribution of the shares of common stock is
completed, SEC rules may limit the underwriters from bidding for
and purchasing shares of our common stock.
In connection with this offering, the underwriters may engage in
transactions that stabilize, maintain or make short sales of our
common stock and may purchase our common stock on the open
market to cover positions created by short sales. Short sales
involve the sale by the underwriters of a greater number of
shares than they are required to purchase in this offering. The
underwriters may close out any short position by purchasing
shares in the open market or by exercising their overallotment
option.
A short position is more likely to be created if the
underwriters are concerned that there may be downward pressure
on the price of the shares in the open market after pricing that
could adversely affect investors who purchase in this offering.
A stabilizing bid is a bid for or the purchase of
common stock on behalf of the underwriters in the open market
prior to the completion of this offering for the purpose of
fixing or maintaining the price of the shares of common stock. A
syndicate covering transaction is the bid for or
purchase of common stock on behalf of the underwriters to reduce
a short position incurred by the underwriters in connection with
the offering.
S-8
Similar to other purchase transactions, the underwriters
purchases to cover the syndicate short sales may have the effect
of raising or maintaining the market price of our shares or
preventing or retarding a decline in the market price of our
shares. As a result, the price of our shares may be higher than
the price that might otherwise exist in the open market.
In connection with this offering, the underwriters may also
engage in passive market making transactions in our common stock
on The NASDAQ Global Market in accordance with Rule 103 of
Regulation M during a period before the commencement of
offers or sales of shares of our common stock in this offering
and extending through the completion of distribution. A passive
market maker must display its bid at a price not in excess of
the highest independent bid of that security. However, if all
independent bids are lowered below the passive market
makers bid, that bid must then be lowered when specified
purchase limits are exceeded.
Neither we nor the underwriters make any representation or
prediction as to the direction or magnitude of any effect that
the transactions described above may have on the price of our
common stock. In addition, neither we nor the underwriters make
any representation that the underwriters will engage in these
transactions or that any transaction, if commenced, will not be
discontinued without notice.
Affiliations
In the future, the underwriters and their affiliates may provide
various investment banking, commercial banking, financial
advisory and other services to us and our affiliates for which
services they have received, and may in the future receive,
customary fees. In the course of their businesses, the
underwriters and their affiliates may actively trade our
securities or loans for their own accounts or for the accounts
of customers, and, accordingly, the underwriters and their
affiliates may at any time hold long or short positions in such
securities or loans.
S-9
Notice to
Investors
European Economic
Area
In relation to each Member State of the European Economic Area
which has implemented the Prospectus Directive (as defined
below) (each, a Relevant Member State), with effect from and
including the date on which the Prospectus Directive is
implemented in that Relevant Member State, or the Relevant
Implementation Date, an offer of our common stock to the public
may not be made in that Relevant Member State prior to the
publication of a prospectus in relation to our common stock
which has been approved by the competent authority in that
Relevant Member State or, where appropriate, approved in another
Relevant Member State and notified to the competent authority in
that Relevant Member State, all in accordance with the
Prospectus Directive, except that an offer to the public in that
Relevant Member State of any shares of our common stock may be
made at any time under the following exemptions under the
Prospectus Directive if they have been implemented in the
Relevant Member State:
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(a)
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to legal entities which are authorized or regulated to operate
in the financial markets or, if not so authorized or regulated,
whose corporate purpose is solely to invest in securities;
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(b)
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to any legal entity which has two or more of (1) an average
of at least 250 employees during the last financial year;
(2) a total balance sheet of more than 43,000,000 and
(3) an annual net turnover of more than 50,000,000,
as shown in its last annual or consolidated accounts;
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(c)
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to fewer than 100 natural or legal persons per Relevant Member
State (other than qualified investors as defined in the
Prospectus Directive); or
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(d)
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in any other circumstances falling within Article 3(2) of
the Prospectus Directive,
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provided that no such offer of our common stock shall result in
a requirement for the publication by us or any underwriter of a
prospectus pursuant to Article 3 of the Prospectus
Directive.
For the purposes of this provision, the expression an
offer of our common stock to the public in relation
to any shares of our common stock in any Relevant Member State
means the communication in any form and by any means of
sufficient information on the terms of the offer and our common
stock to be offered so as to enable an investor to decide to
purchase or subscribe our common stock, as the same may be
varied in that Member State by any measure implementing the
Prospectus Directive in that Member State and the expression
Prospectus Directive means Directive 2003/71/EC and
includes any relevant implementing measure in each Relevant
Member State.
United
Kingdom
Shares of our common stock may not be offered or sold and will
not be offered or sold to any persons in the United Kingdom
other than to persons whose ordinary activities involve them in
acquiring, holding, managing or disposing of investments (as
principal or as agent) for the purposes of their businesses or
otherwise in circumstances which have not resulted or will not
result in an offer to the public in the United Kingdom within
the meaning of the Financial Services and Markets Act 2000, or
the FSMA.
In addition, any invitation or inducement to engage in
investment activity (within the meaning of section 21 of
the FSMA) in connection with the issue or sale of shares of our
common stock may only be communicated or caused to be
communicated in circumstances in which Section 21(1) of the
FSMA does not apply to us. Without limitation to the other
restrictions referred to herein, this prospectus supplement is
directed only at (1) persons outside the United Kingdom or
(2) persons who:
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(a)
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are qualified investors as defined in section 86(7) of
FSMA, being persons falling within the meaning of
article 2.1(e)(i), (ii) or (iii) of the
Prospectus Directive; and
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(b)
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are either persons who fall within article 19(1) of the
Financial Services and Markets Act 2000 (Financial Promotion)
Order 2005, as amended, or Order, or are persons who fall within
article 49(2)(a) to (d) (high net worth companies,
unincorporated associations, etc.) of the Order; or
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(c)
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to whom it may otherwise lawfully be communicated in
circumstances in which Section 21(1) of the FSMA does not
apply.
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Without limitation to the other restrictions referred to herein,
any investment or investment activity to which this offering
circular relates is available only to, and will be engaged in
only with, such persons, and persons within the
S-10
United Kingdom who receive this communication (other than
persons who fall within (2) above) should not rely or act
upon this communication.
Germany
Any offer or solicitation of securities within Germany must be
in full compliance with the German Securities Prospectus Act
(Wertpapierprospektgesetz WpPG). The offer and
solicitation of securities to the public in Germany requires the
publication of a prospectus that has to be filed with and
approved by the German Federal Financial Services Supervisory
Authority (Bundesanstalt für
Finanzdienstleistungsaufsicht BaFin). This
prospectus supplement has not been and will not be submitted for
filing and approval to the BaFin and, consequently, will not be
published. Therefore, this prospectus supplement does not
constitute a public offer under the German Securities Prospectus
Act (Wertpapierprospektgesetz). This prospectus supplement and
any other document relating to our common stock, as well as any
information contained therein, must therefore not be supplied to
the public in Germany or used in connection with any offer for
subscription of our common stock to the public in Germany, any
public marketing of our common stock or any public solicitation
for offers to subscribe for or otherwise acquire our common
stock. This prospectus supplement and other offering materials
relating to the offer of our common stock are strictly
confidential and may not be distributed to any person or entity
other than the designated recipients hereof.
France
This prospectus has not been prepared in the context of a public
offering of financial securities in France within the meaning of
Article L.411-1
of the French Code Monétaire et Financier and Title I
of Book II of the Règlement Général of the
Autorité des marchés financiers (the AMF)
and therefore has not been and will not be filed with the AMF
for prior approval or submitted for clearance to the AMF.
Consequently, the shares of our common stock may not be,
directly or indirectly, offered or sold to the public in France
and offers and sales of the shares of our common stock may only
be made in France to qualified investors (investisseurs
qualifiés) acting for their own, as defined in and in
accordance with
Articles L.411-2
and D.411-1 to D.411-4, D.734-1, D.744-1, D.754-1 and D.764-1 of
the French Code Monétaire et Financier. Neither this
prospectus nor any other offering material may be released,
issued or distributed to the public in France or used in
connection with any offer for subscription on sale of the shares
of our common stock to the public in France. The subsequent
direct or indirect retransfer of the shares of our common stock
to the public in France may only be made in compliance with
Articles L.411-1,
L.411-2, L.412-1 and L.621-8 through L.621-8-3 of the French
Code Monétaire et Financier.
Sweden
This is not a prospectus under, and has not been prepared in
accordance with the prospectus requirements provided for in, the
Swedish Financial Instruments Trading Act [lagen (1991:980) om
handel med finasiella instrument] nor any other Swedish
enactment. Neither the Swedish Financial Supervisory Authority
nor any other Swedish public body has examined, approved, or
registered this document.
S-11
Legal
Matters
The validity of the common stock offered by this prospectus
supplement and the accompanying prospectus will be passed upon
for us by Cooley Godward Kronish LLP, San Diego,
California. Latham & Watkins LLP, San Diego,
California, is counsel for the underwriters in connection with
this offering.
Experts
Stonefield Josephson, Inc., independent registered public
accounting firm, has audited our consolidated financial
statements as of and for the year ended December 31, 2009
and the effectiveness of our internal control over financial
reporting as of December 31, 2009, as set forth in their
reports, each of which are included in our Annual Report on
Form 10-K
for the year ended December 31, 2009 as filed with the SEC
on March 12, 2010, and are incorporated by reference in
this prospectus supplement and elsewhere in the registration
statement. These financial statements are incorporated by
reference in reliance on Stonefield Josephson, Inc.s
reports, given on their authority as experts in accounting and
auditing.
Where You Can
Find More Information
This prospectus supplement and the accompanying prospectus are
part of the registration statement on
Form S-3
we filed with the SEC under the Securities Act and do not
contain all the information set forth in the registration
statement. Whenever a reference is made in this prospectus
supplement or the accompanying prospectus to any of our
contracts, agreements or other documents, the reference may not
be complete and you should refer to the exhibits that are a part
of the registration statement or the exhibits to the reports or
other documents incorporated by reference in this prospectus
supplement and the accompanying prospectus for a copy of such
contract, agreement or other document. Because we are subject to
the information and reporting requirements of the Exchange Act
we file annual, quarterly and current reports, proxy statements
and other information with the SEC. Our SEC filings are
available to the public over the Internet at the SECs
website at
http://www.sec.gov.
You may also read and copy any document we file at the
SECs Public Reference Room at 100 F Street,
N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330
for further information on the operation of the Public Reference
Room.
Incorporation of
Certain Information by Reference
The SEC allows us to incorporate by reference
information from other documents that we file with them, which
means that we can disclose important information to you by
referring you to those documents. The information incorporated
by reference is considered to be part of this prospectus
supplement and the accompanying prospectus. Information
contained in this prospectus supplement and the accompanying
prospectus and information that we file with the SEC in the
future and incorporate by reference in this prospectus
supplement and the accompanying prospectus will automatically
update and supersede this information. We incorporate by
reference the documents listed below and any future filings
(other than Current Reports on
Form 8-K
furnished under Item 2.02 or Item 7.01 and exhibits
filed on such form that are related to such items) we make with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Exchange Act after the date of the prospectus supplement and
until the termination of this offering:
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our Annual Report on
Form 10-K
for the year ended December 31, 2009 filed with the SEC on
March 12, 2010;
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the information specifically incorporated by reference into our
Annual Report on
Form 10-K
for the year ended December 31, 2008 from our definitive
proxy statement on Schedule 14A filed with the SEC on
April 16, 2009;
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our Current Reports on
Form 8-K
filed with the SEC on December 22, 2009, February 9,
2010, March 8, 2010 and April 5, 2010; and
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the description of our common stock set forth in our
registration statement on
Form 8-A12B
(File
No. 001-33734),
filed under the Exchange Act on October 9, 2007, and any
amendment or report filed for the purpose of updating that
description.
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S-12
You can request a copy of these filings, at no cost, by writing
or telephoning us at the following address or telephone number:
Ardea Biosciences, Inc.
4939 Directors Place
San Diego, CA 92121
Attn: Investor Relations
(858) 652-6500
S-13
PROSPECTUS
$75,000,000
Ardea Biosciences, Inc.
Common
Stock
Our common stock is listed on The NASDAQ Global Market under the
symbol RDEA. On June 4, 2009, the last reported
sale price of our common stock on The NASDAQ Global Market was
$15.55 per share.
From time to time, we may sell shares of our common stock in one
or more offerings in amounts, at prices and on the terms that we
will determine at the time of the offering, with an aggregate
initial offering price of up to $75 million. Each time we
offer shares, we will provide you with a supplement to this
prospectus. You should read this prospectus, the information
incorporated by reference in this prospectus and any prospectus
supplement carefully before you invest.
Investing in our common stock involves a high degree of risk.
See Risk Factors on page 4 of this prospectus
and as updated in our future filings made with the Securities
and Exchange Commission, or the SEC, which are incorporated by
reference in this prospectus.
This prospectus may not be used to offer or sell any
securities unless accompanied by a prospectus supplement.
The securities may be sold by us to or through underwriters or
dealers, directly to purchasers or through agents designated
from time to time. For additional information on the methods of
sale, you should refer to the section entitled Plan of
Distribution in this prospectus. If any underwriters are
involved in the sale of any securities with respect to which
this prospectus is being delivered, the names of such
underwriters and any applicable discounts or commissions and
over-allotment options will be set forth in a prospectus
supplement. The price to the public of such securities and the
net proceeds we expect to receive from such sale will also be
set forth in a prospectus supplement.
Neither the SEC nor any state securities commission has
approved or disapproved of these securities or determined if
this prospectus is truthful or complete. Any representation to
the contrary is a criminal offense.
The date of this prospectus is
June 5, 2009.
Table of
Contents
You should rely only on the information contained in or
incorporated by reference into this prospectus or any applicable
prospectus supplement. We have not authorized anyone to provide
you with different information. We are not making an offer to
sell or seeking an offer to buy shares of our common stock under
this prospectus or any applicable prospectus supplement in any
jurisdiction where the offer or sale is not permitted. The
information contained in this prospectus, any applicable
prospectus supplement 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 or any sale of a security.
About This
Prospectus
This prospectus is part of a registration statement that we
filed with the SEC using a shelf registration
process. Under this shelf registration statement, we may sell
common stock in one or more offerings up to a total dollar
amount of $75 million. Each time we sell any of our common
stock under this prospectus, we will provide a prospectus
supplement that will contain more specific information about the
terms of that offering. We may also add, update or change in a
prospectus supplement any of the information contained in this
prospectus or in documents we have incorporated by reference
into this prospectus. This prospectus, together with any
applicable prospectus supplement and the documents incorporated
by reference into this prospectus, include all material
information relating to this offering. You should carefully read
both this prospectus and any applicable prospectus supplement
together with the additional information described under
Where You Can Find More Information before buying
common stock in this offering.
i
Summary
To understand this offering fully and for a more complete
description of the legal terms of this offering as well as our
company and the common stock being sold in this offering, you
should read carefully the entire prospectus, the prospectus
supplement and the other documents to which we may refer you,
including Risk Factors and our consolidated
financial statements and notes to those statements incorporated
by reference in this prospectus. Reference to we,
us, our, our company,
the Company, and RDEA refers to Ardea
Biosciences, Inc. and its subsidiary, unless the context
requires otherwise.
Ardea
Biosciences, Inc.
Overview and
Business Strategy
Ardea Biosciences, Inc., of San Diego, California, is a
biotechnology company focused on the discovery and development
of small-molecule therapeutics for the treatment of gout, human
immunodeficiency virus (HIV), cancer and
inflammatory diseases. We are currently pursuing multiple
development programs, including the following:
Product
Portfolio
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Product Candidate
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Target Indication
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Development Status
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RDEA594
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Gout
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Phase 2 initiating
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RDEA806
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HIV
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Phase 2a completed
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RDEA427
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HIV
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Phase 0* completed
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RDEA119
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Cancer
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Phase 1 and Phase 1/2 ongoing
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RDEA119
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Inflammation
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Phase 1 completed
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RDEA436
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Inflammation
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Phase 0* completed
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First-in-human
micro-dose pharmacokinetic study in normal healthy volunteers. |
GOUT
RDEA594
RDEA594 is an inhibitor of URAT1, a transporter in the kidney
that regulates uric acid excretion from the body. RDEA594 was
well tolerated in Phase 1 studies in normal healthy volunteers
and demonstrated significant dose-related decreases in serum
uric acid of up to 30% over the first 24 hours after
administration of single-ascending doses and up to 45% after
10 days of administration of multiple doses. We plan to
complete a number of additional studies by the end of 2009,
including a Phase 2 dose-ranging study of RDEA594 in gout
patients. The uric acid-lowering activity of RDEA594, when
administered as its prodrug, RDEA806, has also been demonstrated
in a recently completed Phase 2a proof-of-concept study of
RDEA806 in gout patients. All of our future studies in gout will
be conducted directly with RDEA594.
HIV
RDEA806
RDEA806 is our lead non-nucleoside reverse transcriptase
inhibitor, or NNRTI, for the treatment of HIV. In vitro
preclinical tests have shown RDEA806 to be a potent
inhibitor of a wide range of HIV viral isolates, including
isolates that are resistant to efavirenz
(SUSTIVA®/Stocrin®
from Bristol-Myers Squibb Company and Merck & Co.,
Inc.), the most widely prescribed NNRTI, in addition to other
currently available NNRTIs. In vitro preclinical tests
have also shown RDEA806 to have a high genetic barrier to
resistance. In vivo preclinical tests suggest that
RDEA806 does not pose a risk of reproductive toxicity. Based on
both preclinical and clinical data, we anticipate that RDEA806
could be amenable to a once-daily oral dosing regimen, may have
limited pharmacokinetic interactions with other drugs and may be
readily co-formulated in a single pill with other HIV antiviral
drugs, such as
Truvada®
(emtricitabine and tenofovir from Gilead Sciences, Inc.), which
is important for patient compliance and efficacy.
RDEA806 has successfully completed Phase 1 and Phase 2a studies
and has been evaluated in over 250 subjects. Results from a
Phase 2a monotherapy proof-of-concept study of RDEA806
demonstrated placebo-adjusted plasma viral load reductions of up
to 2.0 log10 on day 8 with once-daily dosing of RDEA806. In
addition, all dosing regimens tested were well tolerated. We
have continued preparing RDEA806 for further clinical
development by
1
obtaining additional regulatory approvals to conduct an
international Phase 2b HIV trial and by completing a number of
important preparatory safety and supportive toxicology studies,
including a Thorough QT study. Results from the Thorough QT
study demonstrated that QTc intervals were not increased by any
dose of RDEA806 tested. In addition, the study provided
information on the lack of pharmacokinetic differences between
Caucasians and
African-Americans.
These results provide further support for RDEA806s cardiac
safety profile, as well as its potential to improve current
standard-of-care therapy by decreasing the documented increased
side effects of efavirenz in
African-Americans
believed to result from ethnicity-based differences in
metabolism. We anticipate that the timing of future studies of
RDEA806 will be determined in part by the results of our
partnering efforts.
RDEA427
The lead compound in our next generation NNRTI program, RDEA427,
is from a chemical class that is distinct from the RDEA806
chemical class. Based on early preclinical data, we believe that
RDEA427 may share certain of the positive attributes of RDEA806,
but may also have even greater activity against a wide range of
drug-resistant viral isolates. We have evaluated RDEA427 in a
human micro-dose pharmacokinetic study. We anticipate that the
timing of future studies of RDEA427 will be determined in part
by the results of our partnering efforts.
CANCER
RDEA119
RDEA119, our lead mitogen-activated ERK kinase, or MEK,
inhibitor for the treatment of cancer, is a potent and selective
inhibitor of MEK, which is believed to play an important role in
cancer cell proliferation, apoptosis and metastasis. In vivo
preclinical tests have shown RDEA119 to have potent
anti-tumor activity.
Data from an ongoing Phase 1 study of RDEA119 in advanced cancer
patients suggest that RDEA119 has a pharmacokinetic profile
allowing for convenient once-daily oral dosing. In addition,
preclinical in vitro and in vivo studies of
RDEA119 have demonstrated synergistic activity across multiple
tumor types when RDEA119 is used in combination with other
anti-cancer agents, including sorafenib
(Nexavar®
from Bayer HealthCare AG (Bayer) and Onyx
Pharmaceuticals, Inc.). We are currently conducting a Phase
1/2
study of RDEA119 in combination with sorafenib in advanced
cancer patients to evaluate the safety, tolerability,
pharmacokinetics and anti-tumor activity of this combination
therapy.
Under our Development and License Agreement (the License
Agreement) with Bayer, we are responsible for the
completion of the Phase 1 and Phase
1/2
studies currently being conducted for RDEA119. Thereafter, Bayer
will be responsible for the further development and
commercialization of RDEA119 and any of our other MEK inhibitors.
INFLAMMATION
RDEA119
In vivo preclinical tests have also shown RDEA119 to
significantly inhibit production of inflammatory cytokines.
Results from a completed Phase 1 study in normal healthy
volunteers demonstrated that RDEA119 was well tolerated with a
pharmacokinetic profile allowing for convenient once-daily oral
dosing. The timing of future studies of RDEA119 in inflammatory
diseases, if any, will be determined by Bayer pursuant to the
License Agreement.
RDEA436
The lead compound in our next generation MEK inhibitor program,
RDEA436, is from a chemical class that is distinct from the
RDEA119 chemical class. Based on early preclinical data, we
believe that RDEA436 may potentially share certain of the
positive attributes of RDEA119, and may have even greater
potency than RDEA119. We have evaluated RDEA436 in a human
micro-dose pharmacokinetic study. We received regulatory
approval in December 2008 to initiate a Phase 1 study of RDEA436
evaluating safety, pharmacokinetics and inflammatory disease
biomarkers in normal healthy volunteers. The timing of future
studies of RDEA436 in inflammatory diseases, if any, will be
determined by Bayer pursuant to the License Agreement.
2
Market
Opportunity
We believe that there is a significant market opportunity for
our products, should they be successfully developed, approved
and commercialized.
We believe that there is a significant need for new products for
the treatment and prevention of gout, a painful and debilitating
disease caused by abnormally elevated levels of uric acid. There
has been only one new drug approved in the United States for the
treatment of gout in the last 40 years. According to the
National Arthritis Data Workgroup, an estimated 6.1 million
adults in the United States in 2005 had experienced at least one
episode of gout. The incidence and severity of gout is
increasing in the United States. According to the Annals of
Rheumatic Diseases there was a 288% increase in gout-related
hospitalizations from
1988-2005
and over $11.2 billion in gout-related hospital costs were
incurred in 2005 in the United States. In addition, according to
a 2008 Nerac Inc. survey, approximately 5.0 million
patients in the European Union suffer from gout. Many chronic
gout sufferers are unable to achieve target reductions in uric
acid with current treatments. Approximately 80% to 90% of gout
patients are under excretors of uric acid.
Scientists have recently discovered defects in multiple
transporters in the kidney that play important roles in uric
acid transport and are genetically linked to a higher risk of
gout. URAT1 has been identified as the most important
transporter for uric acid. We are developing products for the
treatment of hyperuricemia and gout that inhibit URAT1, thereby
increasing the excretion of uric acid and lowering serum uric
acid levels. In addition, we believe there may be opportunities
to develop uric acid-lowering agents to treat diseases other
than gout. Evidence suggests that the chronic elevation of uric
acid associated with gout, known as hyperuricemia, may also have
systemic consequences, including an increased risk for kidney
dysfunction, elevated CRP, hypertension and possibly other
cardiovascular risk factors.
In 2007, sales of HIV antivirals in the seven major drug markets
(the United States, Japan, France, Germany, Italy, Spain and the
United Kingdom) were approximately $9.3 billion and are
expected to reach $15.1 billion in 2017, according to
Datamonitor. While the treatment of HIV has improved
dramatically over the past decade, we believe that there remains
a significant need for new treatments that are effective against
drug-resistant virus, safer for women and
African-Americans,
well tolerated and convenient to take. According to the Centers
for Disease Control and Prevention (CDC), 56,300 people
were newly infected with HIV in 2006, 40% more than estimated
previously.
African-Americans
accounted for more than 45% of the new infections. Women account
for 27% of the new infections. We are developing products for
the treatment of HIV that are highly active against resistant
strains, have a high genetic barrier to resistance, have a
better safety profile than current drugs in
African-Americans
and women, can be taken once a day, and are easy to formulate in
a combination pill with current drugs.
We also believe that there is growing interest in the potential
for targeted therapies, including kinase inhibitors, for the
treatment of both cancer and inflammatory disease. Sales of
products used in the treatment of cancer were expected to exceed
$45.0 billion in 2008, according to IMS Health
Incorporated, fueled by strong acceptance of innovative and
effective targeted therapies. The failure rate of kinase
inhibitor compounds in clinical development in oncology is only
53% versus 82% in the oncology field as a whole. In 2007, the
worldwide market for targeted therapies for inflammatory
diseases was more than $8.6 billion. Given the role that
MEK appears to play in cancer and inflammatory diseases and the
increasing preference for oral therapies, we believe that
RDEA119 and our next generation MEK inhibitors, if successfully
developed, approved and commercialized, could participate in
these growing markets.
Bayer
Relationship
On April 28, 2009, we entered into the License Agreement
with Bayer to develop and commercialize small-molecule
mitogen-activated ERK kinase inhibitors for the treatment of
cancer. Under the terms of the License Agreement, we granted to
Bayer a worldwide, exclusive license to develop and
commercialize our MEK inhibitors for all indications. Our lead
product candidate from this program, RDEA119, is currently being
evaluated both as a single agent and in combination with
sorafenib in advanced cancer patients. Bayer has agreed to pay
us a non-refundable, upfront license fee of $35 million for
the development and commercialization rights to our MEK
inhibitors. Potential payments under the License Agreement could
total up to $407 million, not including royalties. We will
also be eligible to receive low double-digit royalties on
worldwide sales of products under the License Agreement.
Valeant
Relationship
On December 21, 2006, we acquired intellectual property and
other assets from Valeant Research & Development, Inc.
related to RDEA806 and our next generation NNRTI program, and
RDEA119 and our next generation MEK
3
inhibitor program. Concurrent with the closing of the
acquisition from Valeant, we hired a new senior management team
and changed our name from IntraBiotics Pharmaceuticals, Inc. to
Ardea Biosciences, Inc.
In consideration for the assets purchased from Valeant and
subject to the satisfaction of certain conditions, Valeant has
the right to receive development-based milestone payments and
sales-based royalty payments from us. There is one set of
milestones for RDEA806 and the next generation NNRTI program and
a separate set of milestones for RDEA119 and the next generation
MEK inhibitor program. In the event of the successful
commercialization of a product incorporating RDEA806 or a
compound from the next generation NNRTI program, resulting
milestone payments could total up to $25.0 million. In the
event of the successful commercialization of a product
incorporating RDEA119 or a compound from the next generation MEK
inhibitor program, resulting milestone payments could total up
to $17.0 million. Milestones are paid only once for each
program, regardless of how many compounds are developed or
commercialized. The first milestone payments of
$2.0 million and $1.0 million in the NNRTI program and
the MEK inhibitor program, respectively, would be due after the
first patient is dosed in the first Phase 2b study, and
approximately 80% of the total milestone payments in each
program would be due upon United States Food and Drug
Administration acceptance and approval of a New Drug
Application, or NDA. The royalty rates on all products are in
the mid-single digits. We agreed to further develop these
compounds with the objective of obtaining marketing approval in
the United States, the United Kingdom, France, Spain, Italy and
Germany.
Valeant also has the right to exercise a one-time option to
repurchase commercialization rights in territories outside the
United States and Canada (the Valeant Territories)
to the first NNRTI compound derived from the acquired
intellectual property to complete a Phase 2b study in HIV. If
Valeant exercises this option, which it can do following the
completion of a Phase 2b HIV study, but prior to the initiation
of a Phase 3 study, we would be responsible for completing Phase
3 studies and for registration of the product in the United
States and the European Union. Valeant would pay us a
$10.0 million option fee, up to $21.0 million in
milestone payments based on regulatory approvals, and a
mid-single-digit royalty on product sales in the Valeant
Territories.
We were incorporated in the State of Delaware in January 1994.
Our corporate offices are located at 4939 Directors Place,
San Diego, CA 92121. Our telephone number is
(858) 652-6500.
Our website address is www.ardeabio.com. We make available free
of charge through our Internet website our annual report on
Form 10-K,
quarterly reports on
Form 10-Q,
current reports on
Form 8-K,
and amendments to those reports filed or furnished pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended, or the Exchange Act, as soon as reasonably
practicable after we electronically file such material with, or
furnish it to, the SEC. Information contained on our website,
unless specifically referenced herein, does not constitute part
of this prospectus or any prospectus supplement.
Risk
Factors
An investment in our common stock involves a high degree of
risk. Before you make a decision to invest in our common stock,
you should consider carefully the risks described in the section
entitled Risk Factors contained in our Annual Report
on
Form 10-K
for the fiscal year ended December 31, 2008, as filed with
the SEC on March 13, 2009, which is incorporated herein by
reference in its entirety, as well as any amendment or update
thereto reflected in subsequent filings with the SEC and any
information in this prospectus or any accompanying prospectus
supplement. If any of these risks 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 to decline and you may lose part or
all of your investment. Moreover, the risks described 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, operating results, prospects or financial
condition.
Forward-Looking
Statements
This prospectus, the documents that we incorporate by reference
herein and the applicable prospectus supplement contain
forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, or
the Securities Act, and Section 21E of the Exchange Act.
Any statements about our expectations, beliefs, plans,
objectives, assumptions or future events or performance are not
historical facts and may be forward-looking. These statements
are often, but not always, made through the use of words or
phrases such as anticipate, estimate, plan, project, continuing,
ongoing, goal, expect, management believes, we believe, we
intend and similar words or phrases. Accordingly, these
statements involve estimates, assumptions and uncertainties that
could cause actual results to differ materially from those
expressed in them. Any forward-looking statements are qualified
in their entirety by reference to the factors discussed in this
prospectus, in the applicable prospectus supplement or
incorporated by reference.
4
Because the factors discussed in this prospectus, incorporated
by reference herein or discussed in the applicable prospectus
supplement, and even factors of which we are not yet aware,
could cause actual results or outcomes to differ materially from
those expressed in any forward-looking statements made by or on
behalf of us, you should not place undue reliance on any such
forward-looking statements. These statements are subject to
risks and uncertainties, known and unknown, which could cause
actual results and developments to differ materially from those
expressed or implied in such statements. We have included
important factors in the cautionary statements included in this
prospectus, in the applicable prospectus supplement,
particularly under the heading RISK FACTORS, and in
our SEC filings that we believe could cause actual results or
events to differ materially from the forward-looking statements
that we make. These and other risks are also detailed in our
reports filed from time to time under the Securities Act
and/or the
Exchange Act. You are encouraged to read these filings as they
are made.
Further, any forward-looking statement speaks only as of the
date on which it is made, and we undertake no obligation to
update any forward-looking statement or statements to reflect
events or circumstances after the date on which such statement
is made or to reflect the occurrence of unanticipated events.
New factors emerge from time to time, and it is not possible for
us to predict which factors will arise. In addition, we cannot
assess the impact of each factor on our business or the extent
to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statements.
5
Use of
Proceeds
Except as described in any prospectus supplement, we currently
intend to use the net proceeds from the sale of the securities
offered hereby to fund the costs of clinical trial and other
research and development activities and for general corporate
purposes, including working capital. We may also use a portion
of the net proceeds to in-license, invest in or acquire
businesses or technologies that we believe are complementary to
our own, although we have no current plans, commitments or
agreements with respect to any acquisitions as of the date of
this prospectus. Pending these uses, we intend to invest the net
proceeds in investment-grade, interest-bearing securities.
Plan of
Distribution
We may sell our common stock covered by this prospectus in any
of three ways (or in any combination):
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to or through underwriters or dealers;
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directly to one or more purchasers; or
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through agents.
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We may distribute the common stock:
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from time to time in one or more transactions 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 the prevailing market prices; or
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at negotiated prices.
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Each time we offer and sell shares of our common stock covered
by this prospectus, we will provide a prospectus supplement or
supplements that will describe the method of distribution and
set forth the terms of the offering, including:
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the name or names of any underwriters, dealers or agents;
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the amounts of securities underwritten or purchased by each of
them;
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the purchase price of the common stock and the proceeds we will
receive from the sale;
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any over-allotment options under which underwriters may purchase
additional common stock from us;
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any underwriting discounts or commissions or agency fees and
other items constituting underwriters or agents
compensation;
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the public offering price of the common stock;
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any discounts, commissions or concessions allowed or reallowed
or paid to dealers; and
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any securities exchange or market on which the common stock may
be listed.
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Any public offering price and any discounts or concessions
allowed or reallowed or paid to dealers may be changed from time
to time. We may determine the price or other terms of the common
stock 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 obligations of
the underwriter, dealer or agent in the applicable prospectus
supplement.
Underwriters or dealers may offer and sell the offered common
stock from time to time in one or more transactions, including
negotiated transactions, at a fixed public offering price or at
varying prices determined at the time of sale. If underwriters
or dealers are used in the sale of any common stock, the common
stock will be acquired by the underwriters or dealers for their
own account and may be resold from time to time in one or more
transactions described above. The common stock may be either
offered to the public through underwriting syndicates
represented by managing underwriters, or directly by
underwriters or dealers. Generally, the underwriters or
dealers obligations to purchase the common stock will be
subject to certain conditions precedent. The underwriters or
dealers will be obligated to purchase all of the common stock if
they purchase any of the common stock, unless otherwise
specified in the prospectus supplement. We may use underwriters
with whom we have a material relationship. We will describe the
nature of any such relationship in the prospectus supplement,
naming the underwriter.
6
We may sell the common stock through agents from time to time.
The prospectus supplement will name any agent involved in the
offer or sale of the common stock and any commissions we pay to
them. Generally, any agent will be acting on a best efforts
basis for the period of its appointment. We may authorize
underwriters, dealers or agents to solicit offers by certain
purchasers to purchase the common stock 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. The contracts will be subject
only to those conditions set forth in the prospectus supplement,
and the prospectus supplement will set forth any commissions we
pay for solicitation of these contracts.
Agents, dealers and underwriters may be entitled to
indemnification by us against certain civil liabilities,
including liabilities under the Securities Act, or to
contribution with respect to payments which the agents, dealers
or underwriters may be required to make in respect thereof.
Agents, dealers and underwriters may be customers of, engage in
transactions with, or perform services for us in the ordinary
course of business.
Any underwriter may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids in
accordance with Regulation M under the Exchange Act.
Overallotment involves sales in excess of the offering size,
which create a short position. This short sales position may
involve either covered short sales or
naked short sales. Covered short sales are short
sales made in an amount not greater than the underwriters
over-allotment option to purchase additional shares in this
offering described above. The underwriters may close out any
covered short position either by exercising their over-allotment
option or by purchasing shares in the open market. To determine
how they will close the covered short position, the underwriters
will consider, among other things, the price of shares available
for purchase in the open market, as compared to the price at
which they may purchase shares through the over-allotment
option. Naked short sales are short sales in excess of the
over-allotment option. The underwriters must close out any naked
short position by purchasing shares in the open market. A naked
short position is more likely to be created if the underwriters
are concerned that, in the open market after pricing, there may
be downward pressure on the price of the shares that could
adversely affect investors who purchase shares in this offering.
Stabilizing transactions permit bids to purchase the underlying
security for the purpose of fixing the price of the security so
long as the stabilizing bids do not exceed a specified maximum.
Penalty bids permit the underwriters to reclaim a selling
concession from a dealer when the securities originally sold by
the dealer are purchased in a covering transaction to cover
short positions.
Similar to other purchase transactions, an underwriters
purchase to cover the syndicate short sales or to stabilize the
market price of our common stock may have the effect of raising
or maintaining the market price of our common stock or
preventing or mitigating a decline in the market price of our
common stock. As a result, the price of the shares of our common
stock may be higher than the price that might otherwise exist in
the open market. The imposition of a penalty bid might also have
an effect on the price of the shares if it discourages resales
of the shares.
Neither we nor the underwriters make any representation or
prediction as to the effect that the transactions described
above may have on the price of the shares. If such transactions
are commenced, they may be discontinued without notice at any
time.
Legal
Matters
The validity of the issuance of the shares of our common stock
offered by this prospectus will be passed upon for us by Cooley
Godward Kronish LLP, San Diego, California.
Experts
Stonefield Josephson, Inc., independent registered public
accounting firm, has audited our consolidated financial
statements as of and for the year ended December 31, 2008
and the effectiveness of Ardea Biosciences, Inc.s internal
control over financial reporting as of December 31, 2008,
as set forth in their reports, each of which are included in our
Annual Report on
Form 10-K
for the year ended December 31, 2008 as filed with the SEC
on March 13, 2009, and are incorporated by reference in
this prospectus and elsewhere in the registration statement.
These financial statements are incorporated by reference in
reliance on Stonefield Josephson, Inc.s reports, given on
their authority as experts in accounting and auditing.
7
Where You Can
Find More Information
We are a reporting company and file annual, quarterly and
current reports, proxy statements and other information with the
Securities and Exchange Commission, or the SEC. You may read and
copy these reports, proxy statements and other information at
the SECs public reference room at 100 F Street,
N.E., Washington, D.C. 20549 or at the SECs other
public reference facilities. Please call the SEC at
1-800-SEC-0330
for more information about the operation of the public reference
room. You can request copies of these documents by writing to
the SEC and paying a fee for the copying costs. Our SEC filings
are also available at the SECs website at
http://www.sec.gov.
This prospectus is part of a registration statement that we
filed with the SEC. The registration statement contains more
information than this prospectus regarding us and our common
stock, including certain exhibits and schedules. You can obtain
a copy of the registration statement from the SEC at the address
listed above or from the SECs internet website.
Incorporation of
Certain Information by Reference
We are allowed to incorporate by reference information contained
in documents that we file with the SEC. This means that we can
disclose important information to you by referring you to those
documents and that the information in this prospectus is not
complete. You should read the information incorporated by
reference for more detail. We incorporate by reference in two
ways. First, we list certain documents that we have already
filed with the SEC. The information in these documents is
considered part of this prospectus. Second, the information in
documents that we file in the future will update and supersede
the current information in, and incorporated by reference in,
this prospectus.
We incorporate by reference the documents listed below and any
filings we will make with the SEC under Section 13(a),
13(c), 14 or 15(d) of the Exchange Act after the date we filed
the initial registration statement of which this prospectus is a
part and before the effective date of the registration statement
and any future filings we will make with the SEC pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act from
the date of this prospectus but prior to the termination of the
offering (in each case, except for the information in any of the
foregoing Current Reports on
Form 8-K
and
Form 8-K/A
furnished under Item 2.02 or Item 7.01 therein):
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Annual report on
Form 10-K
for the year ended December 31, 2008, filed with the SEC on
March 13, 2009;
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Quarterly report on
Form 10-Q
for the quarter ended March 31, 2009, filed with the SEC on
May 11, 2009;
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Current reports on
Form 8-K
filed with the SEC on April 14, 2009, May 1, 2009 and
May 8, 2009 (except for the information in such reports
that shall not be deemed filed for purposes of
Section 18 of the Exchange Act); and
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The description of our common stock set forth in our
registration statement on
Form 8-A12B
(File
No. 001-33734),
filed under the Securities Exchange Act of 1934 on
October 9, 2007, and any amendment or report filed for the
purpose of updating that description.
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You may request a copy of these filings at no cost, by writing
or telephoning us at the following address or telephone number:
Ardea Biosciences, Inc.
4939 Directors Place
San Diego, CA 92121
Attn: Investor Relations
(858) 652-6500
This prospectus is part of a registration statement that we
filed with the SEC. The registration statement contains more
information than this prospectus regarding us and our common
stock, including certain exhibits and schedules. You can obtain
a copy of the registration statement from the SEC at the address
listed above or from the SECs internet website. You should
rely only on the information incorporated by reference or
provided in this prospectus or any prospectus supplement. We
have not authorized anyone else to provide you with different
information. You should not assume that the information in this
prospectus or any prospectus supplement is accurate as of any
date other than the date on the front of these documents.
8
3,500,000 Shares
Common
Stock
Prospectus Supplement
Sole Book-Running
Manager
Jefferies &
Company
Joint Lead Manager
Oppenheimer &
Co.
April 6,
2010