e424b3
This filing
is made pursuant to Rule 424(b)(3) under the Securities Act of
1933
in connection with Registration No. 333-153215
PROSPECTUS
1,094,340 Shares
Ardea Biosciences, Inc.
Common Stock
This prospectus relates to the resale from time to time of up to 1,094,340 shares of our
common stock by the selling stockholders named in this prospectus and the selling stockholders
transferees, which were issued pursuant to a private placement that closed on December 21, 2007.
The private placement is more fully described on pages 18-19 of this prospectus under the heading
Selling Stockholders. We are not selling any securities under this prospectus and will not
receive any of the proceeds from the sale of shares by the selling stockholders.
The selling stockholders may sell the common stock being offered by this prospectus from time
to time on terms to be determined at the time of sale through ordinary brokerage transactions or
through any other means described in this prospectus under Plan of Distribution. The selling
stockholders may sell the shares in negotiated transactions or otherwise, at the prevailing market
price for the shares or at negotiated prices. We will not be paying any underwriting discounts or
commissions in this offering.
Our
common stock is listed on The NASDAQ Global Market under the symbol
RDEA. On September 5,
2008, the last reported sale price of our common stock on The NASDAQ
Global Market was $13.76 per
share.
Investing in our common stock involves a high degree of risk. You are urged to read the
section entitled Risk Factors beginning on page 5 of this prospectus, which describes specific
risks and other information that should be considered before you make an investment decision.
Neither the Securities and Exchange Commission 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 September 8, 2008.
TABLE OF CONTENTS
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You should rely only on the information contained in or incorporated by reference into this
prospectus or any applicable prospectus supplement. We have not, and the selling stockholders have
not, authorized anyone to provide you with different information. Neither we nor the selling
stockholders are 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. Our business, financial condition, results of operations and prospects may have changed
since that date.
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 and the other documents to which we may refer you, including
Risk Factors included below in this prospectus 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
subsidiaries, unless the context requires otherwise.
The following description of our business contains forward-looking statements that involve
risks, uncertainties and assumptions. The actual results may differ materially from those
anticipated in these forward-looking statements as a result of many factors, including but not
limited to those set forth under Risk Factors. All forward-looking statements included in this
document are based on information available to us on the date of this document and we assume no
obligation to update any forward-looking statements contained herein.
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 Human
Immunodeficiency Virus (HIV), gout, cancer and inflammatory diseases. We believe that we are
well-positioned to create stockholder value through our development activities, given our ability
to achieve clinical proof-of-concept relatively quickly and cost-effectively in these disease
areas. 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 |
RDEA806
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HIV
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Phase 2a completed |
RDEA427
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HIV
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Phase 0* completed |
RDEA806 (a prodrug of RDEA594)
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Gout
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Phase 2a ongoing |
RDEA594
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Gout
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Preclinical |
RDEA119
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Cancer
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Phase 1 ongoing |
RDEA119
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Inflammation
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Phase 1 completed |
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. |
HIV
RDEA806
RDEA806 is our lead non-nucleoside reverse transcriptase inhibitor (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 (which is the active
ingredient in Sustiva®, a product developed by Bristol-Myers Squibb), 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 clinical trials and has been evaluated
in over 100 subjects. A Phase 2a monotherapy proof-of-concept study of RDEA806 was completed in
the second quarter of 2008. Results from this study demonstrated an up to 2.0 log placebo-adjusted
reduction in plasma viral load on Day 8 with once-daily dosing of RDEA806. In
addition, all dosing regimens tested were well tolerated.
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Based on these results, we plan to initiate in the third quarter of 2008 a multi-national
Phase 2b study comparing once-daily doses of RDEA806 to efavirenz in first-line patients receiving
background treatment with Truvada over six months of treatment.
RDEA427
The lead compound in our 2nd 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 evaluated RDEA427 in a Phase 0
study in the first quarter of 2008 and have selected RDEA427 as a product candidate. We expect to
initiate a Phase 1 study of RDEA427 in normal healthy volunteers before the end of 2008.
GOUT
RDEA806
RDEA806, a prodrug of RDEA594, is currently being evaluated in a Phase 2a proof-of-concept
study to provide an early confirmation of RDEA594s activity in the target population of gout
patients.
RDEA594
RDEA594, our lead product candidate for the treatment of gout, is a major metabolite of
RDEA806. RDEA594 does not have antiviral activity and is believed to be responsible for the
lowering of serum uric acid levels observed following administration of RDEA806 to over 100
subjects in Phase 1 and Phase 2 clinical trials. We plan to initiate a Phase 1 study of RDEA594 in
normal healthy volunteers and expect to announce the pharmacokinetic and pharmacodynamic results of
this Phase 1 study before the end of 2008.
CANCER
RDEA119
RDEA119, our lead mitogen-activated ERK kinase (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 indicates that it
has a pharmacokinetic profile allowing for convenient once-daily oral dosing. We expect to reach
the maximum tolerated dose (MTD) before the end of the year. Once the MTD is obtained, we plan
to evaluate the activity of RDEA119 in advanced cancer patients with selected tumor types, such as
hepatocellular, sarcoma, glioma, non-small cell lung, colon, pancreatic or thyroid cancer or
melanoma. Based on significant in vitro synergy, we also plan to initiate a study of RDEA119
combined with an approved anticancer drug in advanced cancer patients before the end of 2008.
INFLAMMATION
RDEA119
In vivo preclinical tests have shown RDEA119 to significantly inhibit inflammatory cytokines.
Preclinical data also suggest that RDEA119 may have favorable pharmaceutical properties, including
the potential for convenient once-daily oral dosing. We have completed a Phase 1 study of RDEA119
in normal healthy volunteers, demonstrating a favorable pharmacokinetic profile, safety and
tolerability, and its ability to inhibit inflammatory cytokines. We plan to initiate a Phase 2a
clinical study in an inflammatory disease patient population by the end of 2008.
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RDEA436
The lead compound in our 2nd 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 evaluated RDEA436 in a Phase 0 study in the first
quarter of 2008 and have selected RDEA436 as a product candidate. We plan to initiate a Phase 1
study of RDEA436 in normal healthy volunteers by the end of 2008.
Market Opportunity
We believe that there is a significant market opportunity for our products, should they be
successfully developed, approved and commercialized.
In 2007, the worldwide market for HIV antivirals was approximately $8.1 billion, according to
Decision Resources. 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, well-tolerated and convenient to take.
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.
Approximately three-to-five million Americans suffer from gout, many of whom do not achieve a
target reduction in uric acid with current treatments.
We also believe that there is a 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 are expected to exceed $45 billion in 2008, according to
IMS Health Incorporated, fueled by strong acceptance of innovative and effective targeted
therapies. 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 2nd Generation MEK
inhibitors, if successfully developed, approved and commercialized, could participate in these
growing markets.
Valeant Relationship
On December 21, 2006, we acquired intellectual property and other assets from Valeant Research
& Development, Inc. (Valeant) related to RDEA806 and our 2nd generation NNRTI program,
and RDEA119 and our 2nd generation MEK 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
2nd generation NNRTI program and a separate set of milestones for RDEA119 and the
2nd generation MEK inhibitor program. In the event of the successful commercialization
of a product incorporating RDEA806 or a compound from the 2nd 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 2nd
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 payment 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 (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 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.
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We also entered into a master services agreement with Valeant under which we agreed to advance
a preclinical program in the field of neuropharmacology on behalf of Valeant. Under the agreement,
which has a two-year term, subject to Valeants option to terminate the agreement after the first
year, Valeant paid us $2.6 million in 2007 and $300,000 from January 1, 2008 through June 30,
2008. We are also entitled to development-based milestones of up to $1.0 million. The first
milestone totaling $500,000 was reached in July 2007 when a clinical candidate was selected from
the compounds we had designed under this agreement. With the earlier-than-anticipated
identification of a compound meeting all the criteria for clinical development described in the
master services agreement, resources have been shifted away from designing new compounds.
Accordingly, we did not earn any research support payments for the three months ended June 30,
2008. Valeant owns all intellectual property and commercial rights under this research program.
Company 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. 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.
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RISK FACTORS
You should carefully consider the following information about risks and uncertainties that may
affect us or our business, together with the other information appearing elsewhere in this
prospectus. If any of the following events, described as risks, actually occur, our business,
financial condition, results of operations and future growth prospects would likely be materially
and adversely affected. In these circumstances, the market price of our common stock could decline,
and you may lose all or part of your investment in our securities. An investment in our securities
is speculative and involves a high degree of risk. You should not invest in our securities if you
cannot bear the economic risk of your investment for an indefinite period of time and cannot afford
to lose your entire investment.
Risks Related to Our Business
Development of our products will take years; we may never attain product sales; and we expect to
continue to incur net operating losses.
Our accumulated deficit as of June 30, 2008 was $289.7 million, and we expect to incur
substantial operating losses for the foreseeable future. We expect that most of our resources for
the foreseeable future will be dedicated to research and development and preclinical and clinical
testing of compounds. We expect that the amounts paid to advance the preclinical and clinical
development of our product candidates, including RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and
our other compounds, will increase materially in 2008. Any compounds we advance through preclinical
and clinical development will require extensive and costly development, preclinical testing and
clinical trials prior to seeking regulatory approval for commercial sales. Our most advanced
product candidates, RDEA806, RDEA427, RDEA594, RDEA119 and RDEA436, and any other compounds we
advance into further development, may never be approved for commercial sales. The time required to
achieve product sales and profitability is lengthy and highly uncertain and we cannot assure you
that we will be able to achieve or maintain product sales.
We are not currently profitable and may never become profitable.
To date, we have generated limited revenues and we do not anticipate generating significant
revenues for at least several years, if ever. We expect to increase our operating expenses over at
least the next several years as we plan to advance our product candidates, including RDEA806,
RDEA427, RDEA594, RDEA119 and RDEA436, into further preclinical testing and clinical trials, expand
our research and development activities and acquire or license new technologies and product
candidates. As a result, we expect to continue to incur significant and increasing operating losses
for the foreseeable future. Because of the numerous risks and uncertainties associated with our
research and product development efforts, we are unable to predict the extent of any future losses
or when we will become profitable, if ever. Even if we do achieve profitability, we may not be able
to sustain or increase profitability on an ongoing basis.
Because the results of preclinical studies are not necessarily predictive of future results, we can
provide no assurances that, even if our product candidates are successful in preclinical studies,
such product candidates will have favorable results in clinical trials or receive regulatory
approval.
Positive results from preclinical studies should not be relied upon as evidence that clinical
trials will succeed. Even if our product candidates achieve positive results in clinical studies,
we will be required to demonstrate through clinical trials that these product candidates are safe
and effective for use in a diverse population before we can seek regulatory approvals for their
commercial sale. There is typically an extremely high rate of attrition from the failure of product
candidates proceeding through clinical trials. If any product candidate fails to demonstrate
sufficient safety and efficacy in any clinical trial, then we would experience potentially
significant delays in, or be required to abandon, development of that product candidate. If we
delay or abandon our development efforts of any of our product candidates, then we may not be able
to generate sufficient revenues to become profitable, and our reputation in the industry and in the
investment community would likely be significantly damaged, each of which would cause our stock
price to decrease significantly.
Delays in the commencement of clinical testing of our current and potential product candidates
could result in increased costs to us and delay our ability to generate revenues.
Our product candidates will require preclinical testing and extensive clinical trials prior to
submission of any regulatory application for commercial sales. Delays in the commencement of
clinical testing of our product candidates could significantly increase our product development
costs and delay product commercialization. In addition, many of the factors that may cause, or lead
to, a delay in the commencement of clinical trials may also ultimately lead to denial of regulatory
approval of a product candidate.
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The commencement of clinical trials can be delayed for a variety of reasons, including delays
in:
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demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial; |
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reaching agreement on acceptable terms with prospective contract research organizations and clinical
trial sites; |
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manufacturing quantities of a product candidate sufficient for clinical trials; |
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obtaining approval of an Investigational New Drug Application (IND) from the United States Food and
Drug Administration (FDA) or similar foreign approval; and |
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obtaining institutional review board approval to conduct a clinical trial at a prospective site. |
In addition, the commencement of clinical trials may be delayed due to insufficient patient
enrollment, which is a function of many factors, including the size of the patient population, the
nature of the protocol, the proximity of patients to clinical sites, the availability of effective
treatments for the relevant disease, and the eligibility criteria for the clinical trial.
Delays in the completion of, or the termination of, clinical testing of our current and potential
product candidates could result in increased costs to us and delay or prevent us from generating
revenues.
Once a clinical trial for any current or potential product candidate has begun, it may be
delayed, suspended or terminated by us or the FDA, or other regulatory authorities due to a number
of factors, including:
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ongoing discussions with the FDA or other regulatory authorities regarding
the scope or design of our clinical trials; |
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failure to conduct clinical trials in accordance with regulatory requirements; |
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lower than anticipated retention rate of patients in clinical trials; |
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inspection of the clinical trial operations or trial sites by the FDA or
other regulatory authorities resulting in the imposition of a clinical hold; |
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lack of adequate funding to continue clinical trials; |
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negative results of clinical trials; |
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insufficient supply or deficient quality of product candidates or other
materials necessary for the conduct of our clinical trials; or |
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serious adverse events or other undesirable drug-related side effects
experienced by clinical trial participants. |
Many of these factors that may lead to a delay, suspension or termination of clinical testing
of a current or potential product candidate may also ultimately lead to denial of regulatory
approval of a current or potential product candidate. If we experience delays in the completion of,
or termination of, clinical testing, our financial results and the commercial prospects for our
product candidates will be harmed, and our ability to generate product revenues will be delayed.
If our internal discovery and development efforts are unsuccessful, we will be required to obtain
rights to new products or product candidates from third parties, which we may not be able to do.
Our long-term ability to earn product revenue depends on our ability to successfully advance
our product candidates through clinical development and regulatory approval and to identify and
obtain new products or product candidates through internal development or licenses from third
parties. If the development programs we acquired from Valeant and our internal development programs
are not successful, we will need to obtain rights to new products or product candidates from third
parties. We may be unable to obtain suitable product candidates or products from third parties for
a number of reasons, including:
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we may be unable to purchase or license products or product candidates
on terms that would allow us to make a sufficient financial return
from resulting products; |
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competitors may be unwilling to assign or license products or product
candidate rights to us (in particular, if we are not able to
successfully advance the further development of the product candidates
we acquired from Valeant); or |
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we may be unable to identify suitable products or product candidates
within, or complementary to, our areas of interest relating to the
treatment of HIV, gout, cancer and inflammatory diseases. |
If we are unable to obtain rights to new products or product candidates from third parties,
our ability to generate product revenues and achieve profitability may suffer.
Even if we successfully initiate and complete clinical trials for any product candidate, there are
no assurances that we will be able to submit or obtain FDA approval of a new drug application.
There can be no assurance that if our clinical trials of any potential product candidate are
successfully initiated and completed, we will be able to submit an NDA, to the FDA or that any NDA
we submit will be approved by the FDA in a timely manner, if at all. If we are unable to submit an
NDA with respect to any future product candidate, or if any NDA we submit is not approved by the
FDA, we will be unable to commercialize that product. The FDA can and does reject NDAs and requires
additional clinical trials, even when product candidates performed well or achieved favorable
results in clinical trials. If we fail to commercialize any future product candidate in clinical
trials, we may be unable to generate sufficient revenues to attain profitability and our reputation
in the industry and in the investment community would likely be damaged, each of which would cause
our stock price to decrease.
If we successfully develop products, but those products do not achieve and maintain market
acceptance, our business will not be profitable.
Even if any of our product candidates are approved for commercial sale by the FDA or other
regulatory authorities, our profitability and growth will depend on the degree of market acceptance
of any approved product candidate by physicians, healthcare professionals and third-party payors,
which will in turn depend on a number of factors, including:
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our ability to provide acceptable evidence of safety and efficacy; |
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relative convenience and ease of administration; |
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the prevalence and severity of any adverse side effects; |
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the availability of alternative treatments; |
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pricing and cost effectiveness; and |
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our ability to obtain sufficient third-party insurance coverage or reimbursement. |
In addition, even if any of our potential products achieve market acceptance, we may not be
able to maintain that market acceptance over time if:
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new products or technologies are introduced that are more favorably
received than our potential future products, are more cost effective or
render our potential future products obsolete; or |
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complications arise with respect to use of our potential future products. |
We will need substantial additional funding and may be unable to raise capital when needed, or at
all, which would force us to delay, reduce or eliminate our research and development programs or
commercialization efforts.
Based on current projections, excluding any funds that we may receive from future business
development activities, we believe that our existing cash and cash equivalents will be adequate to
fund our anticipated levels of operations into the second quarter of 2009. However, our business
and operations may change in a manner that would consume available resources at a greater rate than
anticipated. In particular, because most of our resources for the foreseeable future will be used
to advance our product candidates, we
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may not be able to accurately anticipate our future research and development funding needs. We
will need to raise substantial additional capital within the next twelve months to, among other
things:
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fund our research, discovery and development programs; |
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advance our product candidates into and through clinical trials and the regulatory
review and approval process; |
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establish and maintain manufacturing, sales and marketing operations; |
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commercialize our product candidates, if any, that receive regulatory approval; and |
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acquire rights to products or product candidates, technologies or businesses. |
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Our future funding requirements will depend on, and could increase significantly as a result
of, many factors, including: |
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the rate of progress and cost of our research and development activities; |
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whether Valeant terminates our master services agreement or reduces the amount of services that we
provide to Valeant; |
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the scope, prioritization and number of preclinical studies and clinical trials we pursue; |
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the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual
property rights; |
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the costs and timing of regulatory approval; |
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the costs of establishing or contracting for manufacturing, sales and marketing capabilities; |
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the effects of competing technological and market developments; |
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the terms and timing of any collaborative, licensing and other arrangements that we may establish; and |
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the extent to which we acquire or license new technologies, products or product candidates. |
We do not anticipate that we will generate significant continuing revenues for at least
several years, if ever. Until we can generate significant continuing revenues, we expect to satisfy
our future cash needs through public or private equity offerings, debt financings and corporate
collaboration and licensing arrangements, as well as through interest income earned on cash
balances. We cannot be certain that additional funding will be available to us on acceptable terms,
or at all. If funds are not available, we may be required to delay, reduce the scope of or
eliminate one or more of our research or development programs or our commercialization efforts.
Raising additional funds by issuing securities or through collaboration and licensing arrangements
may cause dilution to existing stockholders, restrict our operations or require us to relinquish
proprietary rights.
We may raise additional funds through public or private equity offerings, debt financings or
corporate collaborations and licensing arrangements. We cannot be certain that additional funding
will be available on acceptable terms, or at all. To the extent that we raise additional capital by
issuing equity securities, our stockholders ownership will be diluted. Any debt financing we enter
into may involve covenants that restrict our operations. These restrictive covenants would likely
include, among other things, limitations on borrowing, specific restrictions on the use of our
assets, as well as prohibitions on our ability to create liens, pay dividends, redeem capital
stocks or make investments. In addition, if we raise additional funds through collaboration and
licensing arrangements, it may be necessary to relinquish potentially valuable rights to our
potential products or proprietary technologies, or grant licenses on terms that are not favorable
to us. For example, we might be required to relinquish all or a portion of our sales and marketing
rights with respect to potential products or license intellectual property that enables licensees
to develop competing products in order to complete any such transaction.
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We do not have internal manufacturing capabilities, and if we fail to develop and maintain internal
capabilities or supply relationships with collaborators or other outside manufacturers, we may be
unable to develop or commercialize any products.
Our ability to develop and commercialize any products we may develop will depend in part on
our ability to manufacture, or arrange for collaborators or other parties to manufacture, our
products at a competitive cost, in accordance with regulatory requirements, and in sufficient
quantities for clinical testing and eventual commercialization. We currently do not have any
significant manufacturing arrangements or agreements, as our current product candidates will not
require commercial-scale manufacturing for at least several years, if ever. Our inability to enter
into or maintain manufacturing agreements with collaborators or capable contract manufacturers on
acceptable terms could delay or prevent the development and commercialization of our products,
which would adversely affect our ability to generate revenues and would increase our expenses.
If we are unable to establish sales and marketing capabilities or enter into agreements with third
parties to sell and market any products we may develop, we may be unable to generate product
revenue.
We do not currently have a sales organization for the sales, marketing and distribution of
pharmaceutical products. In order to commercialize any products, we must build our sales,
marketing, distribution, managerial and other non-technical capabilities or make arrangements with
third parties to perform these services. We have not definitively determined whether we will
attempt to establish internal sales and marketing capabilities or enter into agreements with third
parties to sell and market any products we may develop. The establishment and development of our
own sales force to market any products we may develop will be expensive and time consuming and
could delay any product launch, and we cannot be certain that we would be able to successfully
develop this capacity. If we are unable to establish our sales and marketing capability or any
other non-technical capabilities necessary to commercialize any product we may develop, we will
need to contract with third parties to market and sell any products we may develop. If we are
unable to establish adequate sales, marketing and distribution capabilities, whether independently
or with third parties, we may not be able to generate product revenue and may not become
profitable.
We will need to increase the size of our organization, and we may encounter difficulties managing
our growth, which could adversely affect our results of operations.
We will need to expand and effectively manage our managerial, operational, financial and other
resources in order to successfully pursue our research, development and commercialization efforts
and secure collaborations to market and distribute our products. If we continue to grow, it is
possible that our management, accounting and scientific personnel, systems and facilities currently
in place may not be adequate to support this future growth. To manage any growth, we will be
required to continue to improve our operational, financial and management controls, reporting
systems and procedures and to attract and retain sufficient numbers of talented employees. We may
be unable to successfully manage the expansion of our operations or operate on a larger scale and,
accordingly, may not achieve our research, development and commercialization goals.
If we are unable to attract and retain key management and scientific staff, we may be unable to
successfully develop or commercialize our product candidates.
We are a small company, and our success depends on our continued ability to attract, retain
and motivate highly qualified management and scientific personnel. In particular, our research and
drug discovery and development programs depend on our ability to attract and retain highly skilled
chemists, biologists and preclinical personnel, especially in the fields of HIV, gout, cancer and
inflammatory diseases. If we are unable to hire or retain these employees, we may not be able to
advance our research and development programs at the pace we anticipate, and we may not be able to
perform our obligations under our master services agreement with Valeant. We may not be able to
attract or retain qualified management and scientific personnel in the future due to the intense
competition for qualified personnel among biotechnology and pharmaceutical businesses, particularly
in the San Diego, California area. If we are not able to attract and retain the necessary personnel
to accomplish our business objectives, we may experience constraints that will impede significantly
the achievement of our research and development objectives. In addition, all of our employees are
at will employees, which means that any employee may quit at any time and we may terminate any
employee at any time. Currently, we do not have employment agreements with any employees or members
of senior management that provide us any guarantee of their continued employment. If we lose
members of our senior management team, we may not be able to find suitable replacements and our
business may be harmed as a result.
9
Our quarterly results and stock price may fluctuate significantly.
We expect our results of operations and future stock price to be subject to quarterly
fluctuations. During the six months ended June 30, 2008, our closing stock prices ranged from a low
of $11.50 to a high of $16.20. The level of our revenues, if any, our results of operations and our
stock price at any given time will be based primarily on the following factors:
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whether or not we achieve specified research or commercialization milestones under
any agreement that we enter into with collaborators and the timely payment by
potential commercial collaborators of any amounts payable to us or by us to
Valeant or any other party, including the milestone payments that we may make to
Valeant; |
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whether Valeant terminates our master services agreement or reduces the amount of
services that we provide to Valeant; |
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the addition or termination of research or development programs or funding support; |
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the status of development of our product candidates, including results of
preclinical studies and any future clinical trials; |
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variations in the level of expenses related to our product candidates or potential
product candidates during any given period; |
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our execution of collaborative, licensing or other arrangements, and the timing
and accounting treatment of payments we make or receive under these arrangements; |
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our recommendation of additional compounds for preclinical development; and |
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fluctuations in the stock prices of other companies in the biotechnology and
pharmaceuticals industries and in the financial markets generally. |
These factors, some of which are not within our control, may cause the price of our stock to
fluctuate substantially. In particular, if our quarterly operating results fail to meet or exceed
the expectations of securities analysts or investors, our stock price could drop suddenly and
significantly. We believe that quarterly comparisons of our financial results are not necessarily
meaningful and should not be relied upon as an indication of our future performance.
If we engage in any acquisition, we will incur a variety of costs, and we may never realize the
anticipated benefits of the acquisition.
In 2006, we acquired pharmaceutical research and development programs, including our most
advanced product candidates, from Valeant and there is no guarantee that we will be able to
successfully develop the acquired product candidates. We may attempt to acquire businesses,
technologies, services or other products or in-license technologies that we believe are a strategic
fit with our existing development programs, at the appropriate time and as resources permit. In any
acquisition, the process of integrating the acquired business, technology, service or product may
result in unforeseen operating difficulties and expenditures and may divert significant management
attention from our ongoing business operations. These operational and financial risks include:
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assumption and exposure to unknown liabilities; |
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disruption of our business and diversion of our managements time and attention to
acquiring and developing acquired products or technologies; |
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incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions; |
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higher than expected acquisition and integration costs; |
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increased amortization expenses; |
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negative effect on our earnings (or loss) per share; |
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difficulty and cost in combining and integrating the operations and personnel of any
acquired businesses with our operations and personnel; |
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impairment of relationships with key suppliers, contractors or
customers of any acquired businesses due to changes in management
and ownership; and |
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inability to retain key employees of any acquired businesses. |
We may fail to realize the anticipated benefits of any acquisition or devote resources to
potential acquisitions that are never completed. If we fail to successfully identify strategic
opportunities, complete strategic transactions or integrate acquired businesses, technologies,
services or products, then we may not be able to successfully expand our product candidate
portfolio to provide adequate revenue to attain and maintain profitability.
Moving our research and development operations was costly and may be disruptive.
At the end of February 2008, we relocated our research and development activities from our
former Costa Mesa, California facility to a building in San Diego, California. The relocation of
our operations involved significant expense and may result in on-going disruptions to our
operations and the loss of personnel who would be costly to replace. The loss of employees could
also have a significant impact on the continuity and progress of our research and development
programs. The costs and possible disruptions that may result from this recent relocation may
adversely impact our operating results and cash position, interrupt continuing operations, delay or
prevent the commercialization of our products and adversely affect our ability to generate
revenues, any of which could prevent us from achieving profitability.
Earthquake damage to our facilities could delay our research and development efforts and adversely
affect our business.
Our new research and development facility in San Diego, California, is located in a seismic
zone, and there is the possibility of an earthquake, which could be disruptive to our operations
and result in delays in our research and development efforts. In the event of an earthquake, if our
facilities or the equipment in our facilities are significantly damaged or destroyed for any
reason, we may not be able to rebuild or relocate our facility or replace any damaged equipment in
a timely manner and our business, financial condition and results of operations could be materially
and adversely affected.
Valeants exercise of its option to repurchase commercialization rights in territories outside the
United States and Canada could limit the market for our first NNRTI product and adversely affect
our business.
Under the asset purchase agreement that we entered into with Valeant on December 21, 2006,
Valeant retains a one-time option to repurchase commercialization rights in the Valeant Territories
for our first NNRTI product derived from the acquired intellectual property to advance to a Phase
2b HIV clinical trial. If Valeant exercises this option, which it can do following the completion
of a Phase 2b clinical trial, but prior to the initiation of a Phase 3 clinical trial, 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.
However, Valeant would then own all commercialization rights in the Valeant Territories, which may
adversely impact the amount of aggregate revenue we may be able to generate from sales of our NNRTI
product and may negatively impact our potential for long-term growth. Also, if Valeant exercises
its option to repurchase commercialization rights in the Valeant Territories and experiences
difficulties in commercializing our NNRTI product in the Valeant Territories, then our
commercialization efforts in the United States and Canada may be adversely impacted.
Failure to comply with our minimum commitments under the asset purchase agreement with Valeant
could expose us to potential liability or otherwise adversely affect our business.
We agreed to use reasonable efforts to develop the product candidates in the pharmaceutical
research and development programs we acquired from Valeant, with the objective of obtaining
marketing approval for RDEA806, RDEA119 and the lead product candidates from the 2nd
generation NNRTI and MEK inhibitor programs in the United States, the United Kingdom, France,
Spain, Italy and Germany. Our efforts will be designed to consistently advance the program with the
goal of achieving the first milestone event within 24 months of the closing of the transaction with
Valeant. If we fail to make sufficient effort to develop the product candidates, then we may be
subject to a potential lawsuit or lawsuits from Valeant under the asset purchase agreement. If such
a lawsuit were filed, our reputation within the pharmaceutical research and development community
may be negatively impacted and our business may suffer.
11
Failure to achieve and maintain effective internal controls in accordance with Section 404 of the
Sarbanes-Oxley Act could have a material adverse effect on our business and stock price.
Section 404 of the Sarbanes-Oxley Act requires on-going management assessments, beginning with
the year ended December 31, 2007, of the effectiveness of our internal controls over financial
reporting and may, beginning with the year ending December 31,
2008, further require a report by our independent auditors that provides our independent
auditors assessment of the effectiveness of our internal controls. Testing and maintaining
internal controls involves significant costs and can divert our managements attention from other
matters that are important to our business. We and our auditors may not be able to conclude on an
ongoing basis that we have effective internal controls over financial reporting in accordance with
Section 404. Failure to achieve and maintain an effective internal control environment could harm
our operating results and could cause us to fail to meet our reporting obligations. Inferior
internal controls could also cause investors to lose confidence in our reported financial
information, which could have a negative effect on the trading price of our stock.
Our management, including our Chief Executive Officer and Chief Financial Officer, does not
expect that our internal controls over financial reporting will prevent all errors and all fraud. A
control system, no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control systems objectives will be met. Further, the design of a
control system must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent limitations on all
control systems, no evaluation of controls can provide absolute assurance that all control issues
and instances of fraud involving a company have been, or will be, detected. The design of any
system of controls is based in part on certain assumptions about the likelihood of future events,
and we cannot assure you that any design will succeed in achieving its stated goals under all
potential future conditions. Over time, controls may become inadequate because of changes in
conditions or deterioration in the degree of compliance with policies or procedures. Because of the
inherent limitations in cost-effective control systems, misstatements due to error or fraud may
occur and not be detected. We cannot assure you that we or our independent registered public
accounting firm will not identify a material weakness in our internal controls in the future. A
material weakness in our internal controls over financial reporting would require management and
our independent registered public accounting firm to evaluate our internal controls as ineffective.
If our internal controls over financial reporting are not considered effective, we may experience a
loss of public confidence, which could have an adverse effect on our business and on the market
price of our common stock.
Risks Related to Our Industry
Because our product candidates and development and collaboration efforts depend on our intellectual
property rights, adverse events affecting our intellectual property rights will harm our ability to
commercialize products.
Our commercial success depends on obtaining and maintaining patent protection and trade secret
protection of our product candidates and their uses, as well as successfully defending these
patents against third-party challenges. We will only be able to protect our product candidates and
their uses from unauthorized use by third parties to the extent that valid and enforceable patents
or effectively protected trade secrets cover them.
Due to evolving legal standards relating to the patentability, validity and enforceability of
patents covering pharmaceutical inventions and the scope of claims made under these patents, our
ability to obtain and enforce patents is uncertain and involves complex legal and factual
questions. Accordingly, rights under any issued patents may not provide us with sufficient
protection for our product candidates or provide sufficient protection to afford us a commercial
advantage against competitive products or processes. In addition, we cannot guarantee that any
patents will issue from any pending or future patent applications owned by or licensed to us. Even
with respect to patents that have issued or will issue, we cannot guarantee that the claims of
these patents are, or will be valid, enforceable or will provide us with any significant protection
against competitive products or otherwise be commercially valuable to us. For example:
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we might not have been the first to make, conceive, or reduce to practice the inventions
covered by any or all of our pending patent applications; |
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we might not have been the first to file patent applications for these inventions; |
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others may independently develop similar or alternative technologies or duplicate any of
our technologies; |
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it is possible that none of our pending patent applications will result in issued patents; |
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our issued or acquired patents may not provide a basis for commercially viable products,
may not provide us with any competitive advantages, or may be challenged by third
parties; |
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our issued patents may not be valid or enforceable; or |
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the patents of others may have an adverse effect on our business. |
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Patent applications in the United States are maintained in confidence for at least 18 months
after their filing. Consequently, we cannot be certain that the patent applications we are pursuing
will lead to the issuance of any patent or be free from infringement or other claims from third
parties. In the event that a third party has also filed a United States patent application relating
to the product candidates or a similar invention, we may have to participate in interference
proceedings declared by the United States Patent Office to determine priority of invention in the
United States. The costs of these proceedings could be substantial and it is possible that our
efforts would be unsuccessful, resulting in a material adverse effect on our United States patent
position. Furthermore, we may not have identified all United States and foreign patents or
published applications that affect our business either by blocking our ability to commercialize our
product candidates or by covering similar technologies that affect our market.
In addition, some countries, including many in Europe, do not grant patent claims directed to
methods of treating humans, and in these countries patent protection may not be available at all to
protect our product candidates.
Even if patents issue, we cannot guarantee that the claims of those patents will be valid and
enforceable or provide us with any significant protection against competitive products, or
otherwise be commercially valuable to us.
Other companies may obtain patents and/or regulatory approvals to use the same drugs to treat
diseases, other than HIV, gout, cancer and inflammatory diseases. As a result, we may not be able
to enforce our patents effectively because we may not be able to prevent healthcare providers from
prescribing, administering or using another companys product that contains the same active
substance as our products when treating patients with HIV, gout, cancer or inflammatory diseases.
Our business depends upon not infringing the rights of others.
If we are sued for infringing intellectual property rights of others, it will be costly and
time consuming, and an unfavorable outcome in that litigation would have a material adverse effect
on our business. Our commercial success depends upon our ability to develop, manufacture, market
and sell our product candidates without infringing the proprietary rights of third parties. We may
be exposed to future litigation by third parties based on claims that our product candidates or
activities infringe the intellectual property rights of others. Numerous United States and foreign
issued patents and pending patent applications owned by others exist in HIV, gout, cancer,
inflammatory diseases and the other fields in which we may develop products. We cannot assure you
that third parties holding any of these patents or patent applications will not assert infringement
claims against us for damages or seeking to enjoin our activities. We also cannot assure you that,
in the event of litigation, we will be able to successfully assert any belief we may have as to
non-infringement, invalidity or immateriality, or that any infringement claims will be resolved in
our favor.
There is a substantial amount of litigation involving patent and other intellectual property
rights in the biotechnology and biopharmaceutical industries generally. Any litigation or claims
against us, with or without merit, may cause us to incur substantial costs, could place a
significant strain on our financial resources, divert the attention of management from our core
business and harm our reputation. In addition, intellectual property litigation or claims could
result in substantial damages and force us to do one or more of the following if a court decides
that we infringe on another partys patent or other intellectual property rights:
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cease selling, incorporating or using any of our product candidates
that incorporate the challenged intellectual property; |
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obtain a license from the holder of the infringed intellectual
property right, which license may be costly or may not be available on
reasonable terms, if at all; or |
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redesign our processes so that they do not infringe, which could be
costly and time-consuming and may not be possible. |
If we find during clinical evaluation that our product candidates for the treatment of HIV,
gout, cancer or inflammatory diseases should be used in combination with a product covered by a
patent held by another company or institution, and that a labeling instruction is required in
product packaging recommending that combination, we could be accused of, or held liable for,
infringement of the third-party patents covering the product recommended for co-administration with
our product. In that case, we may be required to obtain a license from the other company or
institution to use the required or desired package labeling, which may not be available on
reasonable terms, or at all.
If we fail to obtain any required licenses or make any necessary changes to our technologies,
we may be unable to develop or commercialize some or all of our product candidates.
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Confidentiality agreements with employees and others may not adequately prevent disclosure of trade
secrets and other proprietary information and may not adequately protect our intellectual property.
We also rely on trade secrets to protect our technology, especially where we do not believe
patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. In
order to protect our proprietary technology and processes, we also rely in part on confidentiality
and intellectual property assignment agreements with our employees, consultants and other advisors.
These agreements may not effectively prevent disclosure of confidential information or result in
the effective assignment to us of intellectual property, and may not provide an adequate remedy in
the event of unauthorized disclosure of confidential information or other breaches of the
agreements. In addition, others may independently discover our trade secrets and proprietary
information, and in such case we could not assert any trade secret rights against such party.
Enforcing a claim that a party illegally obtained and is using our trade secrets is difficult,
expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the
United States may be less willing to protect trade secrets. Costly and time-consuming litigation
could be necessary to seek to enforce and determine the scope of our proprietary rights, and
failure to obtain or maintain trade secret protection could adversely affect our competitive
business position.
Many of our competitors have significantly more resources and experience, which may harm our
commercial opportunity.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid
and significant technological change. We have many potential competitors, including major drug and
chemical companies, specialized biotechnology firms, academic institutions, government agencies and
private and public research institutions. Many of our competitors have significantly greater
financial resources, experience and expertise in:
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research and development; |
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preclinical testing; |
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clinical trials; |
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regulatory approvals; |
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manufacturing; and |
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sales and marketing of approved products. |
Smaller or early-stage companies and research institutions may also prove to be significant
competitors, particularly through collaborative arrangements with large and established
pharmaceutical or other companies. We will also face competition from these parties in recruiting
and retaining qualified scientific and management personnel, establishing clinical trial sites and
patient registration for clinical trials, and acquiring and in-licensing technologies and products
complementary to our programs or potentially advantageous to our business. If any of our
competitors succeed in obtaining approval from the FDA or other regulatory authorities for their
products sooner than we do or for products that are more effective or less costly than ours, our
commercial opportunity could be significantly reduced.
If our competitors develop treatments for HIV, cancer or inflammatory diseases, including gout,
that are approved faster, marketed better or demonstrated to be more effective than any products
that we may develop, our commercial opportunity will be reduced or eliminated.
We believe that a significant number of drugs are currently under development and may become
available in the future for the treatment of HIV, gout, cancer and inflammatory diseases. Potential
competitors may develop treatments for HIV, gout, cancer or inflammatory diseases or other
technologies and products that are more effective or less costly than our product candidates or
that would make our technology and product candidates obsolete or non-competitive. Some of these
products may use therapeutic approaches that compete directly with our most advanced product
candidates.
If we cannot establish pricing of our product candidates acceptable to the government, insurance
companies, managed care organizations and other payors, or arrange for favorable reimbursement
policies, any product sales will be severely hindered.
The continuing efforts of the government, insurance companies, managed care organizations and
other payors of health care costs to contain or reduce costs of health care may adversely affect
our ability to set a price we believe is fair for any products we may
develop and our ability to generate adequate revenues and gross margins. Our ability to
commercialize any product candidates successfully will depend in part on the extent to which
governmental authorities, private health insurers and other organizations establish appropriate
reimbursement levels for the cost of any products and related treatments.
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In certain foreign markets, the pricing of prescription pharmaceuticals is subject to
government control. In the United States, given recent federal and state government initiatives
directed at lowering the total cost of health care, the United States Congress and state
legislatures will likely continue to focus on health care reform, the cost of prescription
pharmaceuticals and on the reform of the Medicare and Medicaid systems. The trend toward managed
health care in the United States, which could significantly influence the purchase of health care
services and products, as well as legislative proposals to reform health care, control
pharmaceutical prices or reduce government insurance programs, may result in lower prices for our
product candidates. While we cannot predict whether any legislative or regulatory proposals
affecting our business will be adopted, the announcement or adoption of these proposals could have
a material and adverse effect on our potential revenues and gross margins.
Product liability claims may damage our reputation and, if insurance proves inadequate, the product
liability claims may harm our results of operations.
We face an inherent risk of product liability exposure when we begin testing our product
candidates in human clinical trials, and we will face an even greater risk if we sell our product
candidates commercially. If we cannot successfully defend ourselves against product liability
claims, we will incur substantial liabilities, our reputation may be harmed and we may be unable to
commercialize our product candidates.
Any claims relating to our improper handling, storage or disposal of biological, hazardous and
radioactive materials could be time-consuming and costly.
Our research and development involves the controlled use of hazardous materials, including
chemicals that cause cancer, volatile solvents, radioactive materials and biological materials that
have the potential to transmit disease. Our operations also produce hazardous waste products. We
are subject to federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of these materials and waste products. If we fail to comply with
these laws and regulations or with the conditions attached to our operating licenses, the licenses
could be revoked, and we could be subjected to criminal sanctions and substantial financial
liability or be required to suspend or modify our operations. Although we believe that our safety
procedures for handling and disposing of these materials comply with legally prescribed standards,
we cannot completely eliminate the risk of accidental contamination or injury from these materials.
In the event of contamination or injury, we could be held liable for damages or penalized with
fines in an amount exceeding our resources. In addition, we may have to incur significant costs to
comply with future environmental laws and regulations. We do not currently have a pollution and
remediation insurance policy.
Our business and operations would suffer in the event of system failures.
Despite the implementation of security measures, our internal computer systems are vulnerable
to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and
telecommunication and electrical failures. Any system failure, accident or security breach that
causes interruptions in our operations could result in a material disruption of our research and
drug discovery and development programs. To the extent that any disruption or security breach
results in a loss or damage to our data or applications, or inappropriate disclosure of
confidential or proprietary information, we may incur liability as a result, our research and drug
discovery and development programs may be adversely affected and the further development of our
product candidates may be delayed. In addition, we may incur additional costs to remedy the damages
caused by these disruptions or security breaches.
Risks Related to Our Common Stock
Directors, executive officers, principal stockholders and affiliated entities beneficially own or
control a significant majority of our outstanding voting common stock and together control our
activities.
Our directors, executive officers, principal stockholders and affiliated entities currently
beneficially own or control a significant majority of our outstanding securities. These
stockholders, if they determine to vote in the same manner, would control the outcome of any matter
requiring approval by our stockholders, including the election of directors and the approval of
mergers or other business combination transactions or terms of any liquidation.
Future sales of our common stock may cause our stock price to decline.
Our principal stockholders and affiliated entities hold a substantial number of shares of our
common stock that they are able to sell in the public market. In addition, they currently own
outstanding warrants exercisable for a significant number of shares of common stock. Subject to
prospectus delivery requirements, where applicable, the shares covered by this registration
statement, of which this prospectus is a part, will also be available for sale. The exercise of
warrants, or sales by our current stockholders of a
substantial number of shares, or the expectation that such exercises and/or sales may occur,
could significantly reduce the market price of our common stock.
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Anti-takeover provisions in our charter documents and under Delaware law may make it more difficult
to acquire us.
Provisions in our certificate of incorporation and bylaws could make it more difficult for a
third party to acquire us, even if doing so would be beneficial to our stockholders. These
provisions:
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allow the authorized number of directors to be changed only by resolution of our Board of Directors; |
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require that stockholder actions must be effected at a duly called stockholder meeting and prohibit
stockholder action by written consent; |
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establish advance notice requirements for nominations to our Board of Directors or for proposals
that can be acted on at stockholder meetings; |
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authorize our Board of Directors to issue blank check preferred stock to increase the number of
outstanding shares; and |
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limit who may call stockholder meetings. |
In addition, because we are incorporated in Delaware, we are governed by the provisions of
Section 203 of the Delaware General Corporation Law, which may prohibit large stockholders from
consummating a merger with, or acquisition of us. These provisions may prevent a merger or
acquisition that would be attractive to stockholders and could limit the price that investors would
be willing to pay in the future for our common stock.
We have never paid cash dividends on our common stock and we do not anticipate paying dividends in
the foreseeable future.
We have paid no cash dividends on any of our common stock to date, and we currently intend to
retain our future earnings, if any, to fund the development and growth of our business. In
addition, the terms of any future debt or credit facility may preclude us from paying any
dividends. As a result, capital appreciation, if any, of our common stock will be your sole source
of potential gain for the foreseeable future.
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.
These statements include, but are not limited to, statements regarding our development programs,
our capabilities, our goals, the expected timeline for achievement of our clinical milestones, the
expected properties and benefits of RDEA806 and our other compounds, the results of clinical and
other studies, the size of the market for our products and our financial results. 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, 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.
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.
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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.
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares of our common stock by the selling
stockholders.
The selling stockholders will pay any underwriting discounts and commissions and expenses
incurred by the selling stockholders for brokerage, accounting, tax or legal services or any other
expenses incurred by the selling stockholders in disposing of the shares. We will bear all other
costs, fees and expenses incurred in effecting the registration of the shares covered by this
prospectus, including, without limitation, all registration and filing fees and fees and expenses
of our counsel and our accountants.
17
SELLING STOCKHOLDERS
On December 19, 2007, we entered into a securities purchase agreement with the selling
stockholders named below and other investors, pursuant to which we sold an aggregate of 3,018,868
shares of our common stock, 1,094,340 shares of which were sold to the selling stockholders named
below, in a private placement transaction otherwise referred to in this prospectus as the Private
Placement. We received aggregate gross proceeds of approximately $40,000,000 in connection with the
Private Placement before deduction of placement agent fees and other transaction expenses. This
prospectus covers, among other things, the offer and sale by the selling stockholders listed below
of up to the total number of shares of common stock issued to the selling stockholders pursuant to
the securities purchase agreement.
We are registering the above-referenced shares to permit the selling stockholders listed below
and their pledgees, donees, transferees or other successors-in-interest that receive their shares
after the date of this prospectus to resell the shares in the manner contemplated under the Plan
of Distribution.
The selling stockholders may sell some, all or none of their shares. We do not know how long
the selling stockholders will hold the shares before selling them. We currently have no agreements,
arrangements or understandings with the selling stockholders regarding the sale of any of the
shares other than the securities purchase agreement. The shares offered by this prospectus may be
offered from time to time by the selling stockholders.
The following table sets forth the name of each selling stockholder, the number of shares
owned by each of the respective selling stockholders, the number of shares that may be offered
under this prospectus by such selling stockholders and the number of shares of our common stock to
be owned by the selling stockholders after this offering is completed, assuming that all offered
shares are sold as contemplated herein. The number of shares in the column Number of Shares Being
Offered represents all of the shares that such selling stockholders may offer under this
prospectus. Except as otherwise disclosed in this prospectus (or as disclosed in any document
incorporated by reference) including information incorporated herein by reference, none of the
selling stockholders has, or within the past three fiscal years has had, any position, office or
other material relationship with us. These selling stockholders have advised us that they may enter
into short sales in the ordinary course of their business of investing and trading securities.
These selling stockholders have also advised us that no short sales in our securities were entered
into by them during the period beginning when the selling stockholders obtained knowledge that we
were contemplating a private placement and ending upon the public announcement of the Private
Placement.
Ownership is based upon information provided by each respective selling stockholder, Schedules
13D and 13G and other public documents filed with the SEC up to, and including, July 31, 2008. The
percentages of shares owned after the offering are based on 15,017,887 shares of our common stock
outstanding as of July 31, 2008. In computing the number of shares beneficially owned by a person
and the percentage ownership of that person, shares of common stock that could be issued upon the
exercise of outstanding options and warrants held by that person that are currently exercisable or
exercisable within 60 days of July 31, 2008 are considered outstanding. These shares, however, are
not included in the shares outstanding as of July 31, 2008 when computing the percentage ownership
of each other person.
The selling stockholders may have sold or transferred, in transactions exempt from the
registration requirements of the Securities Act of 1933, some or all of their shares since the date
on which the information in the table is presented. Information about the selling stockholders may
change over time.
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Shares of |
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Common Stock |
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Number of |
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Shares Owned |
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Owned Prior |
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Shares Being |
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After Offering |
Name |
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to Offering(1) |
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Offered |
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Number |
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Percent |
Baker Tisch Investments, L.P.(2) |
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95,646 |
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15,754 |
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79,892 |
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* |
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Baker Bros. Investments II, L.P.(3) |
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77,663 |
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2,059 |
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75,604 |
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* |
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667 L.P.(4) |
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1,494,764 |
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298,040 |
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1,196,724 |
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8.0 |
% |
Baker Brothers Life Sciences, L.P.(5) |
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2,639,184 |
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754,519 |
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1,884,665 |
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12.5 |
% |
14159, L.P.(6) |
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53,943 |
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23,968 |
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29,975 |
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* |
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Baker Bros. Investments, L.P.(7) |
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92,203 |
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92,203 |
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* |
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FBB Associates(8) |
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1,218 |
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1,218 |
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* |
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* |
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Indicates less than one percent ownership. |
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(1) |
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Does not include shares held by affiliates, except as otherwise indicated. |
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(2) |
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The sole general partner of Baker Tisch Investments, L.P. is Baker Tisch
Capital, L.P. The sole general partner of Baker Tisch Capital, L.P. is
Baker Tisch Capital (GP), LLC. Felix Baker and Julian Baker are the
managing members of Baker Tisch Capital (GP), LLC and have voting and
investment control over these shares. Messrs. Baker disclaim beneficial
ownership of these securities, except to the extent of their pecuniary
interest therein. |
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(3) |
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Includes 3,300 shares of common stock issuable upon exercise of warrants.
The sole general partner of Baker Bros. Investments II, LP. is Baker
Bros. Capital, L.P. The the sole general partner of Baker Bros.
Capital, L.P. is Baker Bros. Capital (GP), LLC. Felix Baker and Julian
Baker are the managing members of Baker Bros. Capital (GP), LLC. Messrs.
Baker disclaim beneficial ownership of these securities, except to the
extent of their pecuniary interest therein. |
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(4) |
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Includes 32,580 shares of common stock issuable upon exercise of
warrants. The sole general partner of 667, L.P is Baker Biotech Capital,
L.P.. The the sole general partner of Baker Biotech Capital, L.P. is
Baker Biotech Capital (GP), LLC . Felix Baker and Julian Baker are the
managing members of Baker Biotech Capital (GP), LLC and have voting and
investment control over these shares. Messrs. Baker disclaim beneficial
ownership of these securities, except to the extent of their pecuniary
interest therein. |
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(5) |
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Includes 34,410 shares of common stock issuable upon exercise of
warrants. The sole general partner of Baker Brothers Life Sciences, L.P.
is Baker Brothers Life Sciences Capital, L.P.. The sole general partner
of Baker Brothers Life Sciences Capital, L.P. is Baker Brothers Life
Sciences Capital (GP), LLC. Felix Baker and Julian Baker are the
managing members of Baker Brothers Life Sciences Capital (GP), LLC and
have voting and investment control over these shares. Messrs. Baker
disclaim beneficial ownership of these securities, except to the extent
of their pecuniary interest therein. |
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(6) |
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The sole general partner of 14159, L.P. is 14159 Capital, L.P. The sole
general partner of 14159 Capital, L.P. is 14159 Capital (GP), LLC. Felix
Baker and Julian Baker are the managing members of 14159 Capital (GP),
LLC and have voting and investment control over these shares. Messrs.
Baker disclaim beneficial ownership of these securities, except to the
extent of their pecuniary interest therein. |
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(7) |
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Includes 3,310 shares of common stock issuable upon the exercise of
warrants. The sole general partner of Baker Bros. Investments, L.P. is
Baker Bros. Capital, L.P. The sole general partner of Baker Bros.
Capital, L.P. is Baker Bros. Capital (GP), LLC.. Felix Baker and Julian
Baker are the managing members of Baker Bros. Capital (GP), LLC and have
voting and investment control over these shares. Messrs. Baker disclaim
beneficial ownership of these securities, except to the extent of their
pecuniary interest therein. |
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(8) |
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Felix Baker and Julian Baker are the controlling members of FBB
Associates and have voting and investment control over these shares.
Messrs. Baker disclaim beneficial ownership of these securities, except
to the extent of their pecuniary interest therein. |
PLAN OF DISTRIBUTION
We are registering the shares of common stock issued to the selling stockholders to permit the
resale of these shares of common stock by the holders of the shares of common stock from time to
time after the date of this prospectus. We will not receive any of the proceeds from the sale by
the selling stockholders of the shares of common stock. We will bear all fees and expenses incident
to our obligation to register the shares of common stock.
The selling stockholders may sell all or a portion of the shares of common stock beneficially
owned by them and offered hereby from time to time directly or through one or more underwriters,
broker-dealers or agents. If the shares of common stock are sold through underwriters or
broker-dealers, the selling stockholders will be responsible for underwriting discounts or
commissions or agents commissions. The shares of common stock may be sold on any national
securities exchange or quotation service on which the securities may be listed or quoted at the
time of sale, in the over-the-counter market or in transactions otherwise than on these exchanges
or systems or in the over-the-counter market and in one or more transactions at fixed prices, at
prevailing market prices at the time of the sale, at varying prices determined at the time of sale,
or at negotiated prices. These sales may be effected in transactions, which may involve crosses or
block transactions. The selling stockholders may use any one or more of the following methods when
selling shares:
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ordinary brokerage transactions and transactions in which the broker-dealer solicits
purchasers; |
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block trades in which the broker-dealer will attempt to sell the shares as agent but may
position and resell a portion of the block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its
account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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settlement of short sales entered into after the effective date of the registration
statement of which this prospectus is a part; |
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broker-dealers may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per share; |
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through the writing or settlement of options or other hedging transactions, whether such
options are listed on an options exchange or otherwise; |
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the distribution of the shares by any selling stockholder to its partners, members or
stockholders; |
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through one or more underwritten offerings on a firm commitment or best efforts basis; |
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a combination of any such methods of sale; and |
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any other method permitted pursuant to applicable law. |
The selling stockholders also may resell all or a portion of the shares in open market
transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or
Section 4(1) under the Securities Act, if available, rather than under this prospectus, provided
that they meet the criteria and conform to the requirements of those provisions.
Broker-dealers engaged by the selling stockholders may arrange for other broker-dealers to
participate in sales. If the selling stockholders effect such transactions by selling shares of
common stock to or through underwriters, broker-dealers or agents, such underwriters,
broker-dealers or agents may receive commissions in the form of discounts, concessions or
commissions from the selling stockholders or commissions from purchasers of the shares of common
stock for whom they may act as agent or to whom they may sell as principal. Such commissions will
be in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the
case of an agency transaction will not be in excess of a customary brokerage commission in
compliance with NASD Rule 2440; and in the case of a principal transaction a markup or markdown in
compliance with NASD IM-2440.
In connection with sales of the shares of common stock or otherwise, the selling stockholders
may enter into hedging transactions with broker-dealers or other financial institutions, which may
in turn engage in short sales of the shares of common stock in the course of hedging in positions
they assume. The selling stockholders may also sell shares of common stock short and if such short
sale shall take place after the date that this Registration Statement is declared effective by the
Commission, the selling stockholders may deliver shares of common stock covered by this prospectus
to close out short positions and to return borrowed shares in connection with such short sales. The
selling stockholders may also loan or pledge shares of common stock to broker- dealers that in turn
may sell such shares, to the extent permitted by applicable law. The selling stockholders may also
enter into option or other transactions with broker-dealers or other financial institutions or the
creation of one or more derivative securities which require the delivery to such broker-dealer or
other financial institution of shares offered by this prospectus, which shares such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended
to reflect such transaction). Notwithstanding the foregoing, the selling stockholders have been
advised that they may not use shares registered on this registration statement to cover short sales
of our common stock made prior to the date the registration statement, of which this prospectus
forms a part, has been declared effective by the SEC.
The selling stockholders may, from time to time, pledge or grant a security interest in some
or all of the shares of common stock owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock
from time to time pursuant to this prospectus or any amendment to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act of 1933, as amended, amending, if
necessary, the list of selling stockholders to
include the pledgee, transferee or other successors in interest as selling stockholders under
this prospectus. The selling stockholders also may transfer and donate the shares of common stock
in other circumstances in which case the transferees, donees, pledgees or other successors in
interest will be the selling beneficial owners for purposes of this prospectus.
20
The selling stockholders and any broker-dealer or agents participating in the distribution of
the shares of common stock may be deemed to be underwriters within the meaning of Section 2(11)
of the Securities Act in connection with such sales. In such event, any commissions paid, or any
discounts or concessions allowed to, any such broker-dealer or agent and any profit on the resale
of the shares purchased by them may be deemed to be underwriting commissions or discounts under the
Securities Act. Selling Stockholders who are underwriters within the meaning of Section 2(11) of
the Securities Act will be subject to the prospectus delivery requirements of the Securities Act
and may be subject to certain statutory liabilities of, including but not limited to, Sections 11,
12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as
amended, or the Exchange Act.
Each selling stockholder has informed the Company that it is not a registered broker-dealer
and does not have any written or oral agreement or understanding, directly or indirectly, with any
person to distribute the common stock. Upon the Company being notified in writing by a selling
stockholder that any material arrangement has been entered into with a broker-dealer for the sale
of common stock through a block trade, special offering, exchange distribution or secondary
distribution or a purchase by a broker or dealer, a supplement to this prospectus will be filed, if
required, pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name of each such
selling stockholder and of the participating broker-dealer(s), (ii) the number of shares involved,
(iii) the price at which such shares of common stock were sold, (iv) the commissions paid or
discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such
broker-dealer(s) did not conduct any investigation to verify the information set out or
incorporated by reference in this prospectus, and (vi) other facts material to the transaction. In
no event shall any broker-dealer receive fees, commissions and markups, which, in the aggregate,
would exceed eight percent (8%). The selling stockholders may indemnify any broker-dealer that
participates in transactions involving the sale of the shares of common stock against certain
liabilities, including liabilities arising under the Securities Act.
Under the securities laws of some states, the shares of common stock may be sold in such
states only through registered or licensed brokers or dealers. In addition, in some states the
shares of common stock may not be sold unless such shares have been registered or qualified for
sale in such state or an exemption from registration or qualification is available and is complied
with.
There can be no assurance that any selling stockholder will sell any or all of the shares of
common stock registered pursuant to the shelf registration statement, of which this prospectus
forms a part.
Each selling stockholder and any other person participating in such distribution will be
subject to applicable provisions of the Securities Exchange Act of 1934, as amended, and the rules
and regulations thereunder, including, without limitation, Regulation M of the Exchange Act, which
may limit the timing of purchases and sales of any of the shares of common stock by the selling
stockholder and any other participating person. Regulation M may also restrict the ability of any
person engaged in the distribution of the shares of common stock to engage in market-making
activities with respect to the shares of common stock. All of the foregoing may affect the
marketability of the shares of common stock and the ability of any person or entity to engage in
market-making activities with respect to the shares of common stock.
We will pay all expenses of the registration of the shares of common stock pursuant to the
registration rights agreement, including, without limitation, Securities and Exchange Commission
filing fees and expenses of compliance with state securities or blue sky laws; provided, however,
that each selling stockholder will pay all underwriting discounts and selling commissions, if any
and any related legal expenses incurred by it. We will indemnify the selling stockholders against
certain liabilities, including some liabilities under the Securities Act, in accordance with the
registration rights agreements, or the selling stockholders will be entitled to contribution. We
may be indemnified by the selling stockholders against civil liabilities, including liabilities
under the Securities Act, that may arise from any written information furnished to us by the
selling stockholders specifically for use in this prospectus, in accordance with the related
registration rights agreements, or we may be entitled to contribution.
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.
21
EXPERTS
Stonefield Josephson, Inc., independent registered public accounting firm, has audited our
consolidated financial statements as of and for the year ended December 31, 2007, as set forth in
their report, each of which are included in our Annual Report on Form 10-K for the year ended
December 31, 2007 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 report, given on their authority as experts in accounting and
auditing.
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. The SEC maintains an Internet site that contains reports, proxy and
information statements and other information regarding issuers that file electronically with the
SEC. Our SEC filings are 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 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, 2007, filed with the SEC on
March 24, 2008; |
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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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Quarterly reports on Form 10-Q for the three month period ended March 31, 2008, filed
with the SEC on May 9, 2008, and the three and six month periods ended June 30, 2008, filed
with the SEC on August 14, 2008; and |
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Current reports on Form 8-K filed with the SEC on January 10, 2008, March 18, 2008, March
25, 2008, April 2, 2008, May 13, 2008, May 23, 2008 and June 13, 2008. |
We will provide without charge to each person, including any beneficial owner, to whom this
prospectus is delivered, upon written or oral request of such person, a copy of any and all of the
documents that have been incorporated by reference in this prospectus (not including exhibits to
such documents, unless such exhibits are specifically incorporated by reference in this prospectus
or into such documents). Such request may be directed to:
22
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.
23