e424b5
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-147721
PROSPECTUS SUPPLEMENT NO. 1
(To Prospectus Dated November 30, 2007)
9,240,307 Shares
We
are offering 9,240,307 shares of common stock pursuant to this prospectus supplement and
the accompanying prospectus.
Our common stock is traded on The Nasdaq Global Market under the symbol CADX.
On February 14, 2008, the last reported sale price of our common
stock was $5.34 per share.
Investing in our common stock involves a high degree of risk. You should carefully review and
consider the Risk Factors section beginning on page
S-5 of this prospectus supplement, which
supersede in their entirety the Risk Factors beginning on page 2 of the accompanying prospectus,
before you make an investment decision.
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Maximum |
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Offering |
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Per Share |
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Amount |
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Offering price and proceeds, before expenses, to Cadence Pharmaceuticals, Inc. |
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$5.34 |
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$49,343,239 |
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The
total number of shares to be sold in the offering may be reduced to
approximately 8,056,716 and the proceeds, before expenses, to us, may be reduced to
$43,022,863 pursuant to Nasdaq Marketplace
Rule 4350(i)(1)(B) limitations, pending the determination of the applicability of such rule prior
to the closing of the offering.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus supplement or the accompanying prospectus or determined if this prospectus supplement or
the accompanying prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
The
date of this prospectus supplement is February 14, 2008.
TABLE OF CONTENTS
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S-31 |
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This prospectus supplement is a supplement to the accompanying prospectus that is also part of
this document. This prospectus supplement and the accompanying prospectus are part of a
registration statement that we filed with the Securities and Exchange Commission, or the
Commission, using a shelf registration process. Under this shelf registration process, we may sell
up to an aggregate amount of $100,000,000 of shares of our common stock in one or more offerings.
In this prospectus supplement, we provide you with specific information about the terms of this
offering and certain other information. You should read the information contained in or
incorporated by reference into this prospectus supplement, along with the accompanying prospectus,
carefully before you invest. These documents contain important information you should consider
when making your investment decision. This prospectus supplement may add, update or change
information contained in the accompanying prospectus. To the extent that any statement that we
make in this prospectus supplement is inconsistent with statements made in the accompanying
prospectus, the statements made in this prospectus supplement will be deemed to modify or supersede
those made in the accompanying prospectus. You should read both this prospectus supplement and the
accompanying prospectus together with additional information described under the heading, Where
You Can Find More Information.
You should rely only on the information contained, or incorporated herein by reference, in
this prospectus supplement and contained, or incorporated herein by reference, in the accompanying
prospectus. We have not authorized anyone to provide you with information that is different or
inconsistent. We are offering to sell, and seeking offers to buy, shares of common stock only in
jurisdictions where offers and sales are permitted. The information contained, or incorporated by
reference, in this prospectus supplement and contained, or incorporated herein by reference, in the
accompanying prospectus is accurate only as of the respective dates thereof, regardless of the time of delivery of this prospectus supplement or
the accompanying prospectus, or of any sale of the common stock.
S-1
ABOUT THIS PROSPECTUS SUPPLEMENT
We provide information to you about this offering of shares of our common stock in two
separate documents:
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the accompanying prospectus, which provides general information, some of which may not
apply to this offering; and |
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this prospectus supplement, which provides specific information regarding the terms of
this offering. |
Generally, when we refer to this prospectus, we are referring to both documents combined.
Additional information is incorporated by reference in this prospectus. See Where You Can Find
More Information below. If information in this prospectus supplement is inconsistent with the
accompanying prospectus, you should rely on this prospectus supplement.
As used in this prospectus supplement, Cadence, we, our, us and the company refers
to Cadence Pharmaceuticals, Inc.
S-2
THE OFFERING
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Common stock offered by us
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9,240,307 shares |
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Common stock outstanding before this offering
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29,112,755 shares |
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Common stock to be outstanding after this offering
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38,353,062 shares |
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Use of proceeds
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We currently anticipate using the net proceeds from this offering (i) to fund clinical and
preclinical development of our product candidates, including, but not limited to (A) the funding in
the entirety of one or more Phase III clinical trials to support the safety and efficacy of
Acetavance in acute pain, in addition to the CPI-APA-301
trials, but only if we, in our reasonable judgment, decide to conduct
such trial(s) following any communications between us and the
U.S. Food and Drug Administration, and (B) the review of the
CPI-APA-304 trial and funding of any modifications, revisions or other changes to such trial as
appropriate, and (ii) for general corporate purposes (only to the extent the items described in
(i)(A) and (B) above have been fully funded or amounts required for those items have been reserved
by us). See Use of Proceeds on page S-31. |
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Risk Factors
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See Risk Factors and other information included in this prospectus supplement, or incorporated
herein by reference, for a discussion of factors you should carefully consider before deciding to
invest in shares of our common stock. |
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Nasdaq Global Market symbol
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CADX |
The information above is based on 29,112,755 shares of common stock outstanding as of
December 31, 2007. This number excludes, as of December 31, 2007:
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2,466,825 shares of common stock issuable upon the exercise of stock options
outstanding at a weighted-average exercise price of $6.15 per share; |
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50,331 shares of common stock issuable upon the exercise of warrants outstanding at
a weighted-average exercise price of $12.67 per share; and |
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an aggregate of 1,391,104 shares of common stock reserved for future issuance under
our 2006 Equity Incentive Plan. |
S-3
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights information contained in other parts of this prospectus supplement and
the accompanying prospectus. Because it is a summary, it does not contain all of the information
that you should consider before investing in the shares. You should read this entire prospectus
supplement and the accompanying prospectus carefully, including the Risk Factors, and the
financial statements and other information incorporated by reference in this prospectus supplement
and the accompanying prospectus.
About Cadence Pharmaceuticals, Inc.
We are a biopharmaceutical company focused on in-licensing, developing and commercializing
proprietary product candidates principally for use in the hospital setting. Since our inception in
May 2004, we have in-licensed rights to two product candidates, both of which are currently being
studied in Phase III clinical trials. We have in-licensed the exclusive U.S. and Canadian rights to
Acetavance, formerly known as IV APAP, an intravenous formulation of acetaminophen that is
currently marketed in Europe and in several other markets by Bristol-Myers Squibb Company, or BMS,
for the treatment of acute pain and fever under the brand name Perfalgan®. We have also in-licensed
the exclusive North American and European rights to omiganan pentahydrochloride 1% aqueous gel, or
Omigard, for the prevention and treatment of device-related, surgical wound-related and
burn-related infections. We believe that the hospital setting is a concentrated, underserved market
for pharmaceuticals and anticipate building our own, hospital-focused sales force as our product
candidates approach potential U.S. Food and Drug Administration, or FDA, approval. We intend to
build a leading franchise in the hospital setting, continuing to focus on products that are in late
stages of development, currently commercialized outside the U.S., or approved in the U.S. but with
significant commercial potential for proprietary new uses or formulations.
Our principal executive offices are located at 12481 High Bluff Drive, Suite 200, San Diego,
California 92130 and our telephone number at that location is (858) 436-1400. Prior to November
2004, we were named Strata Pharmaceuticals, Inc.
Information about the company is also available at our website at www.cadencepharm.com, which
includes links to reports we have filed with the Commission. The information on, or accessible
through, our website is not part of this prospectus.
S-4
RISK FACTORS
Investing in our common stock involves a high degree of risk. Before deciding whether to
invest in our common stock, you should consider carefully the risk factors described below, as well
as other information in this prospectus supplement, the accompanying prospectus and the information
incorporated by reference herein or therein. If any of these risks actually occurs, our business,
financial condition, results of operations or cash flow could be seriously harmed. This could cause
the trading price of our common stock to decline, resulting in a loss of all or part of your
investment.
In the near-term, the success of our business will depend on many factors, including the
following risks:
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we are largely dependent on the success of our only two product candidates, Acetavance
and Omigard, and we cannot be certain that our ongoing and planned clinical development
programs will be successful, or sufficient to support new drug applications, or NDAs, or
that either product candidate will receive regulatory approval or be successfully
commercialized; |
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delays in the commencement, enrollment or completion of clinical testing for either of
our product candidates, or significant issues regarding the adequacy of our clinical trial
designs or the execution or success of our clinical trials, could result in increased costs
to us and delay or limit our ability to obtain regulatory approval; |
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the outcome of final analyses of data from our clinical trials of Acetavance or Omigard
may vary from our initial analyses, and the FDA may not agree with our interpretation of
these results; |
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ongoing or planned clinical trials of Acetavance or Omigard may produce negative or
inconclusive results, or may be inconsistent with previous clinical trial results, and we
may decide, or the FDA may require us, to conduct additional clinical trials or to modify
our ongoing clinical trials; |
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even if our product candidates are approved by regulatory authorities, the market
potential for pain, fever, local catheter site infections and other target markets may be
less than anticipated, and we expect intense competition in the hospital marketplace for our
targeted indications; |
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unexpected adverse side effects or inadequate therapeutic efficacy of Acetavance or
Omigard could delay or prevent regulatory approval or commercialization of our product
candidates, or result in recalls or product liability claims against us; |
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delays or quality issues with respect to the completion of required pre-commercialization
manufacturing development activities for our product candidates, including the completion of
adequate stability data, could result in increased costs to us and delay or limit our
clinical trials and our ability to obtain regulatory approval; |
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the patent rights that we have in-licensed covering Acetavance are limited to a specific
intravenous formulation of acetaminophen, and our market opportunity for this product
candidate may be limited by the lack of patent protection for the active ingredient itself
and other formulations that may be developed by competitors; |
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we will require 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 development
programs and commercialization efforts; and |
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we may not be able to maintain patent protection for our products and to commercialize
our products without infringing the patent rights of others. |
Each of these factors, as well as other factors that may impact our business, are described in
more detail in the following discussion. Although the factors highlighted above are among the most
significant, any of the following
factors could materially adversely affect our business or cause our actual results to differ
materially from those
S-5
contained in forward-looking statements we have made in this prospectus and
those we may make from time to time, and you should consider all of the factors described when
evaluating our business.
Risks Related to Our Business and Industry
We are largely dependent on the success of our two product candidates, Acetavance and Omigard, and
we cannot be certain that either of these product candidates will receive regulatory approval or
be successfully commercialized.
We currently have no drug products for sale and we cannot guarantee that we will ever have
marketable drug products. The research, testing, manufacturing, labeling, approval, selling,
marketing and distribution of drug products are subject to extensive regulation by the FDA, and
other regulatory authorities in the U.S. and other countries, which regulations differ from country
to country. We are not permitted to market our product candidates in the U.S. until we receive
approval of a New Drug Application, or NDA, from the FDA. We have not submitted an NDA or received
marketing approval for either of our product candidates. Obtaining approval of an NDA is a lengthy,
expensive and uncertain process. We currently have only two product candidates and our business
success currently depends entirely on their successful development and commercialization.
We have not developed either of our product candidates independently. In March 2006, we
in-licensed rights to intravenous acetaminophen from Bristol-Myers Squibb Company, or BMS, which
currently markets this product in Europe for the treatment of acute pain and fever. Our clinical
development program for this product candidate currently comprises eight clinical trials, including
three pivotal, Phase III efficacy trials, two pharmacokinetic studies and two safety studies. In
January 2008, we announced that our Phase III efficacy trial of Acetavance for the treatment of
pain in adults following abdominal gynecological surgery did not meet its primary endpoint of
demonstrating a statistically significant reduction in patients pain intensity scores over 48
hours compared to placebo. As a result, we are now engaged in communications with the FDA to
obtain the agencys advice regarding our development program for this product candidate. Following
these communications with the FDA, we may decide or the FDA may require us to conduct additional
clinical trials of Acetavance, or to modify our ongoing clinical trials of this product candidate,
which would increase our costs and delay or limit our ability to obtain regulatory approval.
Depending upon the results of these communications with the FDA and assuming successful completion
of all of our planned clinical trials for this product candidate, we currently plan to submit a
505(b)(2) NDA to the FDA in the first half of 2009 requesting marketing approval of Acetavance for
the treatment of acute pain and fever in adults and children. Additional clinical trials may be
required to support the approval of these indications and any additional indications or dosages for
Acetavance, which could delay, or limit the scope of, any regulatory approvals for this product
candidate. Our failure to achieve our product development goals for Acetavance in a timely manner
or at all could adversely affect our business and our stock price.
In July 2004, we in-licensed the rights to our only other product candidate, omiganan pentahydrochloride 1% aqueous gel, or Omigardtm, which is currently being
evaluated in a single Phase III clinical trial for the prevention of local catheter site
infections, or LCSIs, and will require the successful completion of this Phase III clinical trial
before we are able to submit an NDA to the FDA for approval. In July 2007, we announced that the
FDA agreed with our proposal to increase the number of patients to be enrolled in our ongoing Phase
III clinical trial of Omigard from 1,250 to 1,850 patients. Increasing the number of patients has
required greater financial resources than originally anticipated and delayed the completion of
enrollment in this trial to the second quarter of 2008.
These clinical development programs for Acetavance and Omigard may not lead to commercial
products if our clinical trials fail to demonstrate that our product candidates are safe and
effective and, as a result, we fail to obtain necessary approvals from the FDA and similar foreign
regulatory agencies. We may also fail to obtain the necessary approvals if we have inadequate
financial or other resources to advance our product candidates through the clinical trial process.
Any failure to obtain approval of Acetavance or Omigard would have a material and adverse impact on
our business.
If clinical trials of our current or future product candidates do not produce results necessary to
support regulatory approval in the U.S. or elsewhere, we will be unable to commercialize these
products.
To receive regulatory approval for the commercial sale of Acetavance, Omigard or any other
product candidates
S-6
that we may in-license or acquire, we must conduct, at our own expense, adequate
and well-controlled clinical trials to demonstrate efficacy and safety in humans. Clinical testing
is expensive, takes many years and has an uncertain outcome. Clinical failure can occur at any
stage of the testing. Our clinical trials may produce negative or inconclusive results, and we may
decide, or regulators may require us, to conduct additional clinical and/or non-clinical testing.
For example, Migenix Inc., or Migenix, the licensor for our Omigard product candidate,
together with its former collaborator, Fujisawa Healthcare, Inc., or Fujisawa, completed enrollment
in a Phase III clinical trial in February 2003 that demonstrated statistically significant results
for the secondary endpoints of the trial: the prevention of LCSIs and catheter colonization, which
is the growth of microorganisms on the portion of the catheter below the skin surface. However, the
trial did not show statistical significance for the primary endpoint, the prevention of
catheter-related bloodstream infections, or CRBSIs. After the termination of the collaboration
between Migenix and Fujisawa in January 2004, we in-licensed the rights to Omigard from Migenix in
July 2004 and subsequently reached an agreement under the SPA process with the FDA concerning the
protocol for our own Phase III clinical trial of Omigard. In connection with the SPA for Omigard,
the FDA agreed that a single confirmatory Phase III trial will be required for approval for Omigard
and that the prevention of LCSIs will be the sole primary efficacy endpoint, and we initiated this
clinical trial in August 2005. In July 2007, we announced that the FDA agreed with our proposal to
increase the number of patients to be enrolled in our ongoing Phase III clinical trial of Omigard
from 1,250 to 1,850 patients. This proposal was prompted by our planned re-analysis of data from
the initial Phase III clinical trial of Omigard. Using a slightly different, stricter definition of
LCSIs, the re-analysis indicated a statistically significant reduction in the number of LCSIs of
42% in the Omigard treatment arm as compared to the povidone-iodine treatment arm, while the
original analysis of data from this trial indicated a statistically significant reduction of LCSIs
of approximately 49%. Because the target sample size for our ongoing Phase III clinical trial of
Omigard is based, in part, upon the LCSI rate and treatment effect of the original Phase III
clinical trial of this product candidate, we determined that adding patients would be prudent in
order to maintain the statistical power of the study. Additionally, improvements to hospital
infection prevention practices since our Phase III clinical trial of Omigard began may reduce
catheter-related infection rates, which we believe further supports the planned increase in the
number of patients. Increasing the number of patients enrolled in the Omigard Phase III clinical
trial has required greater financial resources than originally anticipated and delay the completion
of enrollment from the second half of 2007 to the second quarter of 2008. However, we cannot be
certain that our ongoing Phase III clinical trial of Omigard will be able to enroll an adequate
number of patients in the trial or ultimately demonstrate statistical significance or otherwise
demonstrate sufficient efficacy and safety to support the filing of an NDA or ultimately lead to
regulatory approval. Furthermore, despite having completed the SPA process, the FDAs agreement
with us on the trial protocol remains subject to future advances in the field or future public
health concerns unrecognized at the time of the FDAs protocol assessment, and any further changes
we may propose to the protocol will remain subject to the FDAs approval.
Our clinical development programs are subject to the risk of failure inherent in the
development of new drugs, and our clinical trials may not demonstrate the safety, tolerability and
effectiveness of our product candidates. For example, in January 2008, we announced that our Phase
III efficacy trial of Acetavance for the treatment of pain in adults following abdominal
gynecological surgery did not meet its primary endpoint of demonstrating a statistically
significant reduction in patients pain intensity scores over 48 hours compared to placebo. Delays
in completing our clinical trials or the rejection of data from a clinical trial by regulatory
authorities will result in increased development costs and could have a material adverse effect on
the development of our product candidates. In addition, our failure to adequately demonstrate the
efficacy and safety of Acetavance, Omigard or any other product candidates that we may in-license
or acquire would prevent receipt of regulatory approval and, ultimately, the commercialization of
that product candidate.
Because the results of earlier clinical trials are not necessarily predictive of future results,
Acetavance, Omigard or any other product candidate we advance into clinical trials may not have
favorable results in later clinical trials or receive regulatory approval.
Success in clinical testing and early clinical trials does not ensure that later clinical
trials will generate adequate
data to demonstrate the efficacy and safety of the investigational drug. A number of companies
in the pharmaceutical industry, including those with greater resources and experience than us, have
suffered significant setbacks in Phase III clinical trials, even after promising results in earlier
clinical trials.
S-7
In March 2006, we in-licensed the rights to Acetavance from BMS, which is currently marketing
intravenous acetaminophen in Europe and other parts of the world under the brand name Perfalgan.
BMS has completed nine post-operative pain clinical trials, mostly in Europe, primarily in support
of European regulatory approvals for this product candidate. However, we do not know at this time
what regulatory weight, if any, the U.S. and Canadian regulatory agencies will give to these
clinical data in supplementing clinical data generated by us for potential regulatory approval of
Acetavance in the U.S. and Canada. The FDA and foreign regulatory agencies may reject these
clinical trial results if they determine that the clinical trials were not conducted in accordance
with requisite regulatory standards and procedures. Furthermore, we have not audited or verified
the accuracy of the primary clinical data provided by BMS and cannot determine their applicability
to our regulatory filings. Even though BMS has obtained marketing approval in Europe and other
territories for Acetavance, we must conduct additional adequate and well controlled clinical trials
in the U.S. to demonstrate Acetavances safety and efficacy in specific indications to gain
regulatory approval in the U.S.
In January 2008, we announced top-line results for our Phase III efficacy trial of Acetavance
for the treatment of pain in adults following abdominal gynecological surgery. This trial did not
meet its primary endpoint of demonstrating a statistically significant reduction in patients pain
intensity scores over 48 hours compared to placebo. However, this same trial did meet several
secondary endpoints, including pain relief, global patient satisfaction and time to rescue
medication. We also announced the results of a Phase III clinical trial of Acetavance for the
treatment of fever in adults, which successfully met its primary endpoint, demonstrating a
statistically significant reduction of endotoxin-induced fever over six hours compared to placebo,
and key secondary endpoints. As a result of the outcome of these recently-completed clinical
trials of Acetavance, we are now engaged in communications with the FDA to obtain the agencys
advice regarding our development program for this product candidate. Following these
communications with the FDA, we may decide or the FDA may require us to conduct additional clinical
trials, or to modify our ongoing clinical trials of this product candidate, which would increase
our costs and delay or limit our ability to obtain regulatory approval. The outcome of final
analyses of data from our recently-completed clinical trials of Acetavance, or from other studies
that we may conduct, may vary from our initial analyses, and the FDA may not agree with our
interpretation of these results. Additional clinical trials may be required to support the
approval of these indications and any additional indications or dosages for Acetavance, which could
delay, or limit the scope of, any regulatory approvals for this product candidate, and we may not
be able to demonstrate the same safety and efficacy for Acetavance in our planned and ongoing Phase
III clinical trials as was demonstrated previously by BMS. Further, if subsequent trial results
are unfavorable or insufficient, we may be forced to further revise the development plan for this
product candidate, which could involve additional significant expense and delay.
Our other product candidate, Omigard, is a novel antimicrobial peptide and is not yet approved
in any jurisdiction. No antimicrobial peptide has been approved by the FDA, including two
antimicrobial peptides with mechanisms of action similar to Omigard that were studied in Phase III
clinical trials. Although Omigard has been studied in more than 750 patients, all of the patients
studied were enrolled in trials conducted or sponsored by Migenix or Fujisawa. Similar to
Acetavance, we obtained electronic databases from the completed Phase III clinical trials sponsored
by Migenix and Fujisawa. As a part of our standard procedure for analyzing data to prepare a final
report of the study for a potential New Drug Application or other applications for marketing
authorization, we re-analyzed the data using a slightly different, stricter definition of LCSIs. In
April 2007, we announced that our re-analysis indicated a statistically significant reduction in
the number of LCSIs of 42% in the Omigard treatment arm as compared to the povidone-iodine
treatment arm, while the original analysis indicated a statistically significant reduction of LCSIs
of approximately 49%. Because the target sample size for our own Phase III clinical trial of
Omigard is based, in part, upon the LCSI rate and treatment effect of the original Phase III
clinical trial of this product candidate, we determined that adding patients would be prudent in
order to maintain the statistical power of the study. In July 2007, we announced that the FDA
agreed with our proposal to increase the number of patients to be enrolled in our ongoing Phase III
clinical trial of Omigard from 1,250 to 1,850 patients. Increasing the number of patients enrolled
in the Phase III clinical trial of Omigard has required greater financial resources than originally
anticipated and delay the completion of enrollment from the second half of 2007 to the second
quarter of 2008. Our
audit and verification of the accuracy of the primary clinical data provided by our licensor
and its former collaborator are continuing, and we cannot determine their applicability to our
regulatory filings. Although the Phase III clinical trial of Omigard conducted by Migenix and
Fujisawa demonstrated favorable, statistically significant results for the prevention of LCSIs and
catheter colonization, secondary endpoints in their trial, we may
S-8
not observe similar results in
our ongoing Phase III clinical trial. Furthermore, the earlier Phase III clinical trial failed to
show statistical significance for the primary endpoint of that trial, the prevention of CRBSIs.
While we will measure the prevention of CRBSIs as a secondary endpoint in our ongoing Phase III
clinical trial of Omigard, our trial is not designed to demonstrate statistical significance for
this secondary endpoint. Although we are targeting a different primary endpoint in our trial, the
prevention of LCSIs, it is possible that we will experience similar, unexpected results. Failure to
satisfy a primary endpoint in a Phase III clinical trial would generally mean that a product
candidate would not receive regulatory approval without one or more further successful Phase III
clinical trials.
The data collected from our clinical trials may not be adequate to support regulatory approval
of Acetavance, Omigard or any other product candidates that we may in-license or acquire. Moreover,
all clinical data reported is taken from databases that may not have been fully reconciled against
medical records kept at the clinical sites. As a result of auditing the data from these earlier
clinical trials and completing the extensive re-analyses that we will need to perform as part of
our standard procedures for preparing final reports of these studies, the previously reported
results may change, which may negatively impact our ongoing Phase III clinical trials, or the
suitability of earlier clinical trials for inclusion in applications for marketing authorization of
our Acetavance and Omigard product candidates. As a result, despite the results reported by others
in earlier clinical trials for our product candidates, we do not know whether any Phase III or
other clinical trials that we may conduct will demonstrate adequate efficacy and safety to result
in regulatory approval to market our product candidates.
Delays in the commencement or completion of clinical trials, or significant issues regarding the
adequacy of our clinical trial designs or the success or execution of our clinical trials, could
result in increased costs to us and delay or limit our ability to obtain regulatory approval for
our product candidates.
If we experience delays in the commencement or completion of our clinical trials, we could
incur significantly higher product development costs and our ability to obtain regulatory approvals
for our product candidates could be delayed. We may also fail to obtain the necessary regulatory
approvals if we have inadequate financial or other resources to advance our product candidates
through the clinical trial process. We do not know whether enrollment in our planned and ongoing
clinical trials of Acetavance will be completed on time, whether our additional planned and ongoing
clinical trials for Acetavance will be completed on schedule, if at all, or whether we will decide,
or the FDA may require us, to increase the number of patients enrolled in our ongoing clinical
trials. Additional clinical trials may be required to support regulatory approvals for the
treatment of acute pain and fever in adults and children and for any additional indications or
dosages for Acetavance, which could delay or limit the scope of any regulatory approvals we may
receive for this product candidate. In July 2007, we announced an estimated delay in the completion
of enrollment for our ongoing Phase III clinical trial of Omigard from the second half of 2007 to
the second quarter of 2008, because of our decision to increase the number of patients to be
enrolled in this trial, and we do not know if this clinical trial will be completed on schedule, or
at all. In January 2008, we announced that our Phase III efficacy trial of Acetavance for the
treatment of pain in adults following abdominal gynecological surgery did not meet its primary
endpoint of demonstrating a statistically significant reduction in patients pain intensity scores
over 48 hours compared to placebo. As a result, we are now engaged in communications with the FDA
to obtain the agencys advice regarding our development program for this product candidate.
Following these communications with the FDA, we may decide or the FDA may require us to conduct
additional clinical trials of Acetavance, or to modify our ongoing clinical trials of this product
candidate, which would increase our costs and delay or limit our ability to obtain regulatory
approval. As a result, we currently anticipate that our submission of a 505(b)(2) NDA to the FDA
for Acetavance may be delayed from the second half of 2008 to the first half of 2009. Depending
upon the results of our communications with the FDA and the results of our other clinical trials
for this product candidate, we may further delay this estimated submission date.
The commencement and completion of clinical trials requires us to identify and maintain a
sufficient number of trial sites, many of which may already be engaged in other clinical trial
programs for the same indication as our product candidates or may not be eligible to participate in
or may be required to withdraw from a clinical trial as a result of changing standards of care. For
example, we believe that improvements to hospital infection prevention
practices since we commenced enrollment in our Phase III clinical trial of Omigard may reduce
catheter-related infection rates, which may result in the occurrence of an insufficient number of
infections to demonstrate statistical significance in this clinical trial or require an even larger
number of patients to be
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enrolled in order to demonstrate a statistically significant effect.
Although the FDA agreed with our proposal to increase the number of patients to be enrolled in our
ongoing Phase III clinical trial of Omigard, we may be unable to enroll an adequate number of
patients and, even if we enroll our target number of additional patients, we may still be unable to
demonstrate statistical significance or otherwise demonstrate sufficient efficacy and safety to
support the filing of an NDA for Omigard. The commencement and completion of clinical trials can be
delayed for a variety of other reasons, including delays related to:
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reaching agreements on acceptable terms with prospective clinical research organizations,
or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and trial sites; |
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obtaining regulatory approval to commence or amend a clinical trial; |
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obtaining institutional review board approval to commence or amend a clinical trial at a
prospective site; |
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recruiting and enrolling patients to participate in clinical trials for a variety of
reasons, including competition from other clinical trial programs for the same indication as
our product candidates; and |
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retaining patients who have initiated a clinical trial but who may be prone to withdraw
due to the treatment protocol, lack of efficacy, personal issues, side effects from the
therapy or who are lost to further follow-up. |
In addition, a clinical trial may be suspended or terminated by us, the FDA or other
regulatory authorities due to a number of factors, including:
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failure to conduct the clinical trial in accordance with regulatory requirements or our
clinical protocols; |
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inspections of our own clinical trial operations, the operations of our CROs, or our
clinical trial sites by the FDA or other regulatory authorities, which may result in the
imposition of a clinical hold or, potentially, prevent us from using some of the data
generated from our clinical trials to support requests for regulatory approval of our
product candidates; |
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new information suggesting unacceptable risk to subjects, or unforeseen safety issues or
any determination that a trial presents unacceptable health risks; |
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new information suggesting that the target condition occurs too infrequently for the
product candidate to demonstrate efficacy; or |
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lack of adequate funding to continue the clinical trial, including the incurrence of
unforeseen costs due to enrollment delays, requirements to conduct additional trials and
studies and increased expenses associated with the services of our CROs and other third
parties. |
Additionally, changes in regulatory requirements and guidance may occur, or new information
concerning the product candidate or the target medical condition may emerge, and we may need to
perform additional, unanticipated non-clinical testing of our product candidates or amend clinical
trial protocols to reflect these developments. Additional non-clinical testing would add costs and
could delay or result in the denial of regulatory approval for a product candidate. Amendments may
require us to resubmit our clinical trial protocols to institutional review boards for
reexamination, which may impact the costs, timing or successful completion of a clinical trial. If
we experience delays in the completion of, or if we terminate, our clinical trials, the commercial
prospects for our product candidates will be harmed, and our ability to generate product revenues
will be delayed. In addition, many of the factors that cause, or lead to, a delay in the
commencement or completion of clinical trials may also ultimately lead to the denial of regulatory
approval of a product candidate. Even if we are able to ultimately commercialize our product
candidates, other therapies for the same indications may have been introduced to the market and
established
a competitive advantage.
We expect intense competition in the territories in which we have rights to our product
candidates, and new products may emerge that provide different or better therapeutic alternatives
for our targeted indications.
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The biotechnology and pharmaceutical industries are subject to rapid and intense technological
change. We face, and will continue to face, competition in the development and marketing of our
product candidates from academic institutions, government agencies, research institutions and
biotechnology and pharmaceutical companies. There can be no assurance that developments by others
will not render our product candidates obsolete or noncompetitive. Furthermore, new developments,
including the development of other drug technologies and methods of preventing the incidence of
disease, occur in the pharmaceutical industry at a rapid pace. These developments may render our
product candidates obsolete or noncompetitive.
We intend to develop Acetavance for the treatment of acute pain in the hospital setting, which
will compete with well-established products for this and similar indications, including opioids
such as morphine, fentanyl, meperidine and hydromorphone, each of which is available generically
from several manufacturers, and several of which are available as proprietary products using novel
delivery systems, as well as an extended release injectable (epidural) formulation of morphine,
DepoDur. Ketorolac, an injectable non-steroidal anti-inflammatory drug, or NSAID, is also available
generically in the U.S. from several manufacturers and used to treat acute pain. During the time
that it will take us to obtain regulatory approval for Acetavance, if at all, we anticipate that
several additional products may be developed for the treatment of acute pain, including other
injectable NSAIDs, novel opioids, new formulations of currently available opioids, long-acting
local anesthetics and new chemical entities as well as alternative delivery forms of various
opioids and NSAIDs.
We are also developing our Omigard product candidate for the prevention of catheter-related
infections in the hospital setting. If approved, Omigard will compete with well-established topical
products that are currently used in practice to prevent these infections as well as BioPatch, a
device marketed by Johnson & Johnson, which has been approved for wound dressing and prevention of
catheter-related infections. Other competitive products may also be under development.
In addition, competitors may seek to develop alternative formulations of our product
candidates that address our targeted indications that do not directly infringe on our in-licensed
patent rights. For example, we are aware of several U.S. and Canadian patents and patent
applications covering various potential injectable formulations of acetaminophen, including
intravenous formulations, as well as methods of making and using these potential formulations.
Furthermore, there are third-party patents covering analogs of omiganan and Migenix has patented
analogs of omiganan that are not licensed to us. The commercial opportunity for our product
candidates could be significantly harmed if competitors are able to develop alternative
formulations outside the scope of our in-licensed patents. Compared to us, many of our potential
competitors have substantially greater:
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capital resources; |
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development resources, including personnel and technology; |
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clinical trial experience; |
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regulatory experience; |
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expertise in prosecution of intellectual property rights; and |
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manufacturing, distribution and sales and marketing experience. |
As a result of these factors, our competitors may obtain regulatory approval of their products
more rapidly than we are able to or may obtain patent protection or other intellectual property
rights that limit our ability to develop or commercialize our product candidates. Our competitors
may also develop drugs that are more effective, useful and less costly than ours and may also be
more successful than us in manufacturing and marketing their products. We
also expect to face similar competition in our efforts to identify appropriate collaborators
or partners to help develop or commercialize our product candidates in markets outside the U.S.
If any of our product candidates for which we receive regulatory approval do not achieve broad
market acceptance, the revenues that we generate from their sales will be limited.
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The commercial success of our product candidates for which we obtain marketing approval from
the FDA or other regulatory authorities will depend upon the acceptance of these products by the
medical community and coverage and reimbursement of them by third-party payors, including
government payors. The degree of market acceptance of any of our approved products will depend on a
number of factors, including:
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limitations or warnings contained in a products FDA-approved labeling, including
potential limitations or warnings for Acetavance that may be more restrictive than oral
formulations of acetaminophen; |
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changes in the standard of care for the targeted indications for either of our product
candidates could reduce the marketing impact of any superiority claims that we could make
following FDA approval; |
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limitations inherent in the approved indication for either of our product candidates
compared to more commonly-understood or addressed conditions, including, in the case for
Omigard, the ability to promote Omigard to hospitals and physicians who may be more focused
on an indication specifically for the prevention of CRBSIs compared to the prevention of
LCSIs, the primary endpoint in our ongoing Phase III clinical trial; and |
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potential advantages over, and availability of, alternative treatments, including, in the
case of Acetavance, a number of products already used to treat acute pain in the hospital
setting, and in the case for Omigard, a number of competitive topical products as well as a
device that has been approved for wound dressing and prevention of catheter-related
infections. |
Our ability to effectively promote and sell our product candidates in the hospital marketplace
will also depend on pricing and cost effectiveness, including our ability to produce a product at a
competitive price and our ability to obtain sufficient third-party coverage or reimbursement. Since
many hospitals are members of group purchasing organizations, which leverage the purchasing power
of a group of entities to obtain discounts based on the collective buying power of the group, our
ability to attract customers in the hospital marketplace will also depend on our ability to
effectively promote our product candidates to group purchasing organizations. We will also need to
demonstrate acceptable evidence of safety and efficacy as well as relative convenience and ease of
administration. Market acceptance could be further limited depending on the prevalence and severity
of any expected or unexpected adverse side effects associated with our product candidates. If our
product candidates are approved but do not achieve an adequate level of acceptance by physicians,
health care payors and patients, we may not generate sufficient revenue from these products, and we
may not become or remain profitable. In addition, our efforts to educate the medical community and
third-party payors on the benefits of our product candidates may require significant resources and
may never be successful.
The decreasing use of the comparator product in our clinical trial of Omigard and improvements in
hospital infection control practices that lower catheter infection rates may limit our ability to
complete the trial in a timely manner and hinder the competitive profile of this product
candidate.
Over the last several years, many hospitals, particularly in the U.S., have increased the use
of a particular antiseptic, chlorhexidine, as their standard of care to sterilize catheter
insertion sites. Although we believe 10% povidone-iodine continues to be used by a sufficient
number of hospitals to support continued enrollment of patients in our Phase III clinical trial of
Omigard, this changing standard of care limits the number of potential clinical trial sites
available to us. Accordingly, it may be difficult for us to maintain the clinical trial sites that
we have already retained for the Omigard trial if any of these institutions elects to replace our
comparator product with chlorhexidine, and it may take us longer than anticipated to identify and
reach terms with additional hospitals to serve as clinical trial sites for the trial. Delays in the
completion of enrollment or clinical testing for our ongoing Phase III clinical trial of Omigard
and any other studies we may conduct to compare Omigard to chlorhexidine or
another topical antiseptic could significantly affect our product development costs, our
prospects for regulatory approval and our ability to compete. Furthermore, the decreasing use of
10% povidone-iodine in favor of chlorhexidine could reduce the marketing impact of any superiority
claims that we could make following FDA approval. For example, hospitals and physicians may be
reluctant to adopt the use for Omigard in combination with chlorhexidine antisepsis for the
prevention of LCSIs. Additionally, we believe that improvements to hospital infection control
practices since we commenced enrollment in our ongoing Phase III clinical trial of Omigard may
reduce catheter-related infection rates, which may result in the occurrence of an insufficient
number of infections to
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demonstrate statistical significance in this clinical trial or require an
even larger number of patients to be enrolled in order to demonstrate a statistically significant
effect. Even if Omigard is approved by the FDA, if this product candidate does not achieve an
adequate level of acceptance by physicians, health care payors and patients, we may be unable to
generate sufficient revenues to recover our development costs or otherwise sustain and grow our
business.
Even if our product candidates receive regulatory approval, they may still face future development
and regulatory difficulties.
Even if U.S. regulatory approval is obtained, the FDA may still impose significant
restrictions on a products indicated uses or marketing or impose ongoing requirements for
potentially costly post-approval studies. Any of these restrictions or requirements could adversely
affect our potential product revenues. For example, the label ultimately approved for Acetavance,
Omigard or any other product candidates that we may in-license or acquire, if any, may include a
restriction on the term of its use, or it may not include one or more of our intended indications.
Our product candidates will also be subject to ongoing FDA requirements for the labeling,
packaging, storage, advertising, promotion, record-keeping and submission of safety and other
post-market information on the drug. In addition, approved products, manufacturers and
manufacturers facilities are subject to continual review and periodic inspections. If a regulatory
agency discovers previously unknown problems with a product, such as adverse events of
unanticipated severity or frequency, or problems with the facility where the product is
manufactured, a regulatory agency may impose restrictions on that product or us, including
requiring withdrawal of the product from the market. If our product candidates fail to comply with
applicable regulatory requirements, such as current Good Manufacturing Practices, or cGMPs, a
regulatory agency may:
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issue warning letters or untitled letters; |
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require us to enter into a consent decree, which can include imposition of various fines,
reimbursements for inspection costs, required due dates for specific actions and penalties
for noncompliance; |
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impose other civil or criminal penalties; |
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suspend regulatory approval; |
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suspend any ongoing clinical trials; |
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refuse to approve pending applications or supplements to approved applications filed by
us; |
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impose restrictions on operations, including costly new manufacturing requirements; or |
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seize or detain products or require a product recall. |
Even if our product candidates receive regulatory approval in the U.S., we may never receive
approval or commercialize our products outside of the U.S.
Our rights to Acetavance are limited to the U.S. and Canada, and our rights to Omigard are
limited to North America and Europe. In order to market any products outside of the U.S., we must
comply with numerous and varying regulatory requirements of other countries regarding non-clinical
testing, manufacturing, safety and efficacy. Approval procedures vary among countries and can
involve additional product testing and additional
administrative review periods. The time required to obtain approval in other countries might
differ from that required to obtain FDA approval. The regulatory approval process in other
countries may include all of the risks detailed above regarding FDA approval in the U.S. as well as
other risks. Regulatory approval in one country does not ensure regulatory approval in another, but
a failure or delay in obtaining regulatory approval in one country may have a negative effect on
the regulatory process in others. Failure to obtain regulatory approval in other countries or any
delay or setback in obtaining such approval could have the same adverse effects detailed above
regarding FDA approval in the U.S. As described above, such effects include the risks that our
product candidates may not be approved for all indications requested, which could limit the uses of
our product candidates and have an adverse
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effect on product sales and potential royalties, and that such approval may be subject to limitations on the indicated uses for which the
product may be marketed or require costly, post-marketing follow-up studies.
We have never marketed a drug before, and if we are unable to establish an effective sales and
marketing infrastructure, we will not be able to successfully commercialize our product
candidates.
In the U.S., we plan to build our own sales force to market our products directly to
physicians, nurses, hospitals, group purchasing organizations and third-party payors. We currently
do not have significant internal sales, distribution and marketing capabilities. In order to
commercialize any of our product candidates, we must either acquire or internally develop sales and
marketing capabilities, or enter into collaborations with partners to perform these services for
us. The acquisition or development of a hospital-focused sales and marketing infrastructure for our
domestic operations will require substantial resources, will be expensive and time consuming and
could negatively impact our commercialization efforts, including delay any product launch.
Moreover, we may not be able to hire a sales force that is sufficient in size or has adequate
expertise. If we are unable to establish our sales and marketing capability or any other
capabilities necessary to commercialize any products we may develop, we will need to contract with
third parties to market and sell our products. If we are unable to establish adequate sales and
marketing capabilities, whether independently or with third parties, we may not be able to generate
any product revenue, may generate increased expenses and may never become profitable.
We will need to obtain FDA approval of our proposed product names, Acetavance and Omigard, and
any failure or delay associated with such approval may adversely impact our business.
Any name we intend to use for our product candidates will require approval from the FDA
regardless of whether we have secured a formal trademark registration from the U.S. Patent and
Trademark Office. The FDA typically conducts a rigorous review of proposed product names, including
an evaluation of the potential for confusion with other product names. The FDA may also object to a
product name if it believes the name inappropriately implies medical claims. If the FDA objects to
either of the product names Acetavance or Omigard, we may be required to adopt an alternative name
for those product candidates. If we adopt an alternative name, we would lose the benefit of our
existing trademark applications for Acetavance and/or Omigard and may be required to expend
significant additional resources in an effort to identify a suitable product name that would
qualify under applicable trademark laws, not infringe the existing rights of third parties and be
acceptable to the FDA. We may be unable to build a successful brand identity for a new trademark in
a timely manner or at all, which would limit our ability to commercialize our product candidates.
Our product candidates may have undesirable side effects that could delay or prevent their
regulatory approval or commercialization.
Undesirable side effects caused by our product candidates could interrupt, delay or halt
clinical trials and could result in the denial of regulatory approval by the FDA or other
regulatory authorities for any or all targeted indications, and in turn prevent us from
commercializing our product candidates and generating revenues from their sale. For example, the
adverse events related to Acetavance observed in clinical trials completed to date include
transient liver enzyme elevations, nausea or vomiting, allergic reactions, and pain or local skin
reactions at the injection site. When used in excess of the current guidelines for administration,
acetaminophen has an increased potential to cause liver toxicity. While we do not expect the
administration of acetaminophen in intravenous form will result in an increased risk of toxicity to
the liver compared with an equivalent dose of acetaminophen administered orally, we cannot be
certain that increased liver toxicity or other drug-related side effects will not be
observed in future clinical trials or that the FDA will not require additional trials or
impose more severe labeling restrictions due to liver toxicity or other concerns. Drug-related
adverse events observed in clinical trials completed to date for Omigard have been primarily
limited to local skin reactions, including redness, swelling, bleeding, itching, bruising and pain.
In addition, while these drug-related adverse events have generally been related to the skin,
including the catheter insertion site, we cannot be certain that other drug-related side effects
will not be reported in clinical trials or thereafter.
If either of our product candidates receives marketing approval and we or others later
identify undesirable side effects caused by the product:
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regulatory authorities may require the addition of labeling statements, specific warnings
or a contraindication; |
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regulatory authorities may suspend or withdraw their approval of the product, or require
it to be removed from the market; |
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we may be required to change the way the product is administered, conduct additional
clinical trials or change the labeling of the product; and |
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our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of the
affected product or could substantially increase our commercialization costs and expenses, which in
turn could delay or prevent us from generating significant revenues from its sale.
If the government or third-party payors fail to provide coverage and adequate coverage and payment
rates for our future products, if any, or if hospitals choose to use therapies that are less
expensive, our revenue and prospects for profitability will be limited.
In both domestic and foreign markets, our sales of any future products will depend in part
upon the availability of coverage and reimbursement from third-party payors. Such third-party
payors include government health programs such as Medicare, managed care providers, private health
insurers and other organizations. In particular, many U.S. hospitals receive a fixed reimbursement
amount per procedure for certain surgeries and other treatment therapies they perform. Because this
amount may not be based on the actual expenses the hospital incurs, hospitals may choose to use
therapies which are less expensive when compared to our product candidates. Accordingly,
Acetavance, Omigard or any other product candidates that we may in-license or acquire, if approved,
will face competition from other therapies and drugs for these limited hospital financial
resources. We may need to conduct post-marketing studies in order to demonstrate the
cost-effectiveness of any future products to the satisfaction of hospitals, other target customers
and their third-party payors. Such studies might require us to commit a significant amount of
management time and financial and other resources. Our future products might not ultimately be
considered cost-effective. Adequate third-party coverage and reimbursement might not be available
to enable us to maintain price levels sufficient to realize an appropriate return on investment in
product development.
Governments continue to propose and pass legislation designed to reduce the cost of
healthcare. In the U.S., we expect that there will continue to be federal and state proposals to
implement similar governmental controls. For example, in December 2003, Congress enacted a limited
prescription drug benefit for Medicare beneficiaries in the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003. Under this program, drug prices for certain
prescription drugs are negotiated by drug plans, with the goal to lower costs for Medicare
beneficiaries. In some foreign markets, the government controls the pricing of prescription
pharmaceuticals. In these countries, pricing negotiated with governmental authorities can take six
to 12 months or longer after the receipt of regulatory marketing approval for a product. Cost
control initiatives could decrease the price that we would receive for any products in the future,
which would limit our revenue and profitability. Accordingly, legislation and regulations affecting
the pricing of pharmaceuticals might change before our product candidates are approved for
marketing. Adoption of such legislation could further limit reimbursement for pharmaceuticals.
If we breach any of the agreements under which we license rights to our product candidates from
others, we could lose the ability to continue the development and commercialization of our product
candidates.
In March 2006, we entered into an exclusive license agreement with BMS relating to
our Acetavance product candidate for the U.S. and Canada, and in July 2004, we entered into an
exclusive license agreement with Migenix relating to our Omigard product candidate for North
America and Europe. Because we have in-licensed the rights to our two product candidates from third
parties, if there is any dispute between us and our licensors regarding our rights under these
license agreements, our ability to develop and commercialize these product candidates may be
adversely affected. Any uncured, material breach under these license agreements could result in our
loss of exclusive rights to the related product candidate and may lead to a complete termination of
our product development efforts for the related product candidate.
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If BMS breaches the underlying agreement under which we sublicense the rights to our Acetavance
product candidate, we could lose the ability to develop and commercialize Acetavance.
Our license for Acetavance is subject to the terms and conditions of a license from SCR
Pharmatop to BMS, under which BMS originally licensed the intellectual property rights
covering Acetavance. If BMS materially breaches the terms or conditions of this underlying license
from SCR Pharmatop, and neither BMS nor we adequately cure that breach, or BMS and SCR Pharmatop
otherwise become involved in a dispute, the breach by BMS or disputes with SCR Pharmatop could
result in a loss of, or other material adverse impact on, our rights under our license agreement
with BMS. While we would expect to exercise all rights and remedies available to us, including
seeking to cure any breach by BMS, and otherwise seek to preserve our rights under the patents
licensed by SCR Pharmatop, we may not be able to do so in a timely manner, at an acceptable cost or
at all. Any uncured, material breach under the license from SCR Pharmatop to BMS could result
indirectly in our loss of exclusive rights to our Acetavance product candidate and may lead to a
complete termination of our product development and any commercialization efforts for Acetavance.
We rely on third parties to conduct our clinical trials, including our ongoing Phase III clinical
program for Acetavance and our ongoing Phase III clinical trial of Omigard. If these third parties
do not successfully carry out their contractual duties or meet expected deadlines, we may not be
able to obtain regulatory approval for or commercialize our product candidates on our anticipated
timeline or at all.
We rely primarily on third-party CROs to manage the execution of our clinical trials for
our Acetavance and Omigard product candidates, and we depend on independent clinical investigators,
medical institutions and contract laboratories to conduct our clinical trials. Although we rely on
CROs to manage the execution of our clinical trials, we are responsible for oversight and for
ensuring that each of our clinical trials is conducted in accordance with its investigational plan
and protocol. Moreover, the FDA requires us and our CROs to comply with regulations and standards,
commonly referred to as good clinical practices, or GCPs, for conducting, monitoring, recording and
reporting the results of clinical trials to ensure that the data and results are scientifically
credible and accurate and that the trial subjects are adequately informed of the potential risks of
participating in clinical trials. Our reliance on CROs does not relieve us of these
responsibilities and requirements. CROs and investigators are not our employees, and we cannot
control the amount or timing of resources that they devote to our programs. If our CROs or
independent investigators fail to devote sufficient care, time and resources to our drug
development programs, if their performance is substandard, or if they are inspected by the FDA and
are found not to be in compliance with GCPs, it will delay the approval of our FDA applications and
our introductions of new products. The CROs with which we contract for execution of our clinical
trials play a significant role in the conduct of the trials and the subsequent collection and
analysis of data. Failure of the CROs to meet their obligations could adversely affect clinical
development of our product candidates. Moreover, these independent investigators and CROs may also
have relationships with other commercial entities, some of which may have competitive products
under development or currently marketed. If independent investigators and CROs assist our
competitors, it could harm our competitive position. If any of these third parties do not
successfully carry out their contractual duties or obligations or meet expected deadlines, or if
the quality or accuracy of the clinical data is compromised for any reason, our clinical trials may
be extended, delayed or terminated, and we may not be able to obtain regulatory approval
for Acetavance, Omigard or future product candidates.
If the manufacturers upon whom we rely fail to complete required pre-commercialization
manufacturing development activities on time, we may face delays in the development of, or in obtaining
regulatory approvals for, our product candidates, which would result in increased costs and the
loss of potential revenues.
We do not manufacture any of our product candidates, and we do not currently plan to develop
any capacity to do so. Instead, we rely on third party manufacturers to perform
pre-commercialization manufacturing development activities for, and manufacture, Acetavance,
Omigard and, most likely, any other product candidates that we may in-license or acquire in the
future. Any problems or delays we experience in preparing for commercial-scale manufacturing of a
product candidate may cause us to experience increased costs, result in delays in receiving FDA or
other regulatory approvals, or impair our ability to manufacture our product candidates, which
would adversely affect our business. For example, as a part of our applications for regulatory
approval, our manufacturers will need to produce specific batches of our product candidates to
demonstrate acceptable stability under various conditions and for commercially viable lengths of
time. We and our contract manufacturers will need to demonstrate to the
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FDA and other regulatory authorities this acceptable stability data, as well as validate methods and manufacturing
processes, in order to receive regulatory approval to commercialize our product candidates. Any
delays in the availability of this data may cause delays in receiving FDA or other regulatory
authority approvals. Additionally, the FDA is likely to conduct inspections of our manufacturers
facilities from time to time, including as part of its review of any marketing applications we may
file. If our manufacturers are not in compliance with cGMP requirements, this may delay the
approval by the FDA of these marketing applications, or result in delays in the availability of our
product candidates to complete clinical trials or for commercial distribution.
If the manufacturers upon whom we rely terminate our supply agreements or fail to produce our
product candidates in the volumes we require on a timely basis, or to comply with stringent
regulations applicable to pharmaceutical manufacturers, we may face delays in the development and
commercialization of, or be unable to meet demand for, our product candidates and may lose
potential revenues.
If the commercial manufacturers upon whom we rely to manufacture our product candidates fail
to deliver the required commercial quantities of bulk drug substance or finished product on a
timely basis at commercially reasonable prices that meet all applicable quality standards, we would
likely be unable to meet demand for our products and we would lose potential revenues. We have
entered into a development and supply agreement with Baxter Healthcare Corporation, or Baxter, for
the completion of pre-commercialization manufacturing development activities and the manufacture of
commercial supplies of the finished Acetavance. Any termination or disruption of our relationship
with Baxter may materially harm our business and financial condition, and frustrate any
commercialization efforts for Acetavance. We do not yet have agreements established regarding
commercial supply of Omigard and may not be able to establish or maintain commercial manufacturing
arrangements on commercially reasonable terms for Omigard, or any other product candidates that we
may in-license or acquire. We are currently negotiating with suppliers for the commercial supply of
the active pharmaceutical ingredient, or API, for Acetavance and for the commercial supply of API
and finished drug product for Omigard. We do not have any long-term commitments from our suppliers
of clinical trial material or guaranteed prices for our product candidates or placebos, and we do
not have alternate manufacturing plans in place at this time. If we need to change to other
manufacturers or change the manufacturing processes for our product candidates, the FDA and
comparable international regulatory authorities must approve these manufacturers facilities and
processes prior to our use, which would require new testing and compliance inspections, and the new
manufacturers would have to be educated in, or independently develop, the processes necessary for
the production of our products. If there are delays in obtaining approvals of any new
manufacturers, we could experience delays in the availability of our product candidates to complete
our clinical trials or for commercial distribution.
The manufacture of pharmaceutical products requires significant expertise and capital
investment, including the development of advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter difficulties in production, particularly
in scaling up initial production. These problems include difficulties with production costs and
yields, quality control, including stability of the product candidate and quality assurance
testing, shortages of qualified personnel, as well as compliance with strictly enforced federal,
state and foreign regulations. Our manufacturers may not perform as agreed. If our manufacturers
were to encounter any of these difficulties, our ability to provide product candidates to patients
in our clinical trials would be jeopardized.
In addition, all manufacturers of our product candidates must comply with cGMP requirements
enforced by the FDA through its facilities inspection program. These requirements include quality control,
quality assurance and the maintenance of records and documentation. Manufacturers of our product
candidates may be unable to comply with these cGMP requirements and with other FDA, state and
foreign regulatory requirements. We have little control over our manufacturers compliance with
these regulations and standards. A failure to comply with these requirements may result in fines
and civil penalties, suspension of production, suspension or delay in product approval, product
seizure or recall, or withdrawal of product approval. If the safety of any quantities supplied is
compromised due to our manufacturers failure to adhere to applicable laws or for other reasons, we
may not be able to obtain regulatory approval for or successfully commercialize our product
candidates.
Our future growth depends on our ability to identify and acquire or in-license products and if we
do not successfully identify and acquire or in-license related product candidates or integrate
them into our operations, we may have limited growth opportunities.
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We in-licensed the rights to each of our two current product candidates, Acetavance and
Omigard, from third parties who conducted the initial development of each product candidate. An
important part of our business strategy is to continue to develop a pipeline of product candidates
by acquiring or in-licensing products, businesses or technologies that we believe are a strategic
fit with our focus on the hospital marketplace. Future in-licenses or acquisitions, however, may
entail numerous operational and financial risks, including:
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exposure to unknown liabilities; |
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disruption of our business and diversion of our managements time and attention to
develop 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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difficulty and cost in combining the operations and personnel of any acquired businesses
with our operations and personnel; |
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impairment of relationships with key suppliers 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 have limited resources to identify and execute the acquisition or in-licensing of
third-party products, businesses and technologies and integrate them into our current
infrastructure. In particular, we may compete with larger pharmaceutical companies and other
competitors in our efforts to establish new collaborations and in-licensing opportunities. These
competitors likely will have access to greater financial resources than us and may have greater
expertise in identifying and evaluating new opportunities. Moreover, we may devote resources to
potential acquisitions or in-licensing opportunities that are never completed, or we may fail to
realize the anticipated benefits of such efforts.
We will need to increase the size of our organization, and we may experience difficulties in
managing growth.
As of January 31, 2008, we had 48 full-time employees. We will need to continue to expand our
managerial, operational, financial and other resources in order to manage and fund our operations
and clinical trials, continue our development activities and commercialize our product candidates.
Our management, personnel, systems and facilities currently in place may not be adequate to support
this future growth. Our need to effectively manage our operations, growth and various projects
requires that we:
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manage our clinical trials effectively, including our ongoing Phase III clinical program
for Acetavance, which will be conducted at numerous clinical trial sites in the U.S., and our ongoing Phase III
clinical trial of Omigard, which is being conducted at numerous clinical sites in the U.S. and
Europe; |
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manage our internal development efforts effectively while carrying out our contractual
obligations to licensors and other third parties; and |
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continue to improve our operational, financial and management controls, reporting systems
and procedures. |
We may be unable to successfully implement these tasks on a larger scale and, accordingly, may
not achieve our development and commercialization goals.
We may not be able to manage our business effectively if we are unable to attract and retain key
personnel.
We may not be able to attract or retain qualified management and scientific and clinical
personnel in the future
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due to the intense competition for qualified personnel among biotechnology,
pharmaceutical and other businesses, particularly in the San Diego, California area. If we are not
able to attract and retain necessary personnel to accomplish our business objectives, we may
experience constraints that will significantly impede the achievement of our development
objectives, our ability to raise additional capital and our ability to implement our business
strategy.
Our industry has experienced a high rate of turnover of management personnel in recent years.
We are highly dependent on the product acquisition, development, regulatory and commercialization
expertise of our senior management, particularly Theodore R. Schroeder, our President and Chief
Executive Officer, James B. Breitmeyer, M.D., Ph.D., our Executive Vice President, Development and
Chief Medical Officer, and William R. LaRue, our Senior Vice President, Chief Financial Officer,
Treasurer and Assistant Secretary. If we lose one or more of these key employees, our ability to
successfully implement our business strategy could be seriously harmed. Replacing key employees may
be difficult and may take an extended period of time because of the limited number of individuals
in our industry with the breadth of skills and experience required to develop, gain regulatory
approval of and commercialize products successfully. Competition to hire from this limited pool is
intense, and we may be unable to hire, train, retain or motivate these additional key personnel.
Although we have employment agreements with Mr. Schroeder, Dr. Breitmeyer and Mr. LaRue, these
agreements are terminable at will at any time with or without notice and, therefore, we may not be
able to retain their services as expected.
In addition, we have scientific and clinical advisors who assist us in our product development
and clinical strategies. These advisors are not our employees and may have commitments to, or
consulting or advisory contracts with, other entities that may limit their availability to us, or
may have arrangements with other companies to assist in the development of products that may
compete with ours.
We face potential product liability exposure, and if successful claims are brought against us, we
may incur substantial liability for a product candidate and may have to limit its
commercialization.
The use of our product candidates in clinical trials and the sale of any products for which we
obtain marketing approval expose us to the risk of product liability claims. Product liability
claims might be brought against us by consumers, health care providers or others using,
administering or selling our products. If we cannot successfully defend ourselves against these
claims, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability
claims may result in:
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withdrawal of clinical trial participants; |
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termination of clinical trial sites or entire trial programs; |
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decreased demand for our product candidates; |
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impairment of our business reputation; |
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costs of related litigation; |
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substantial monetary awards to patients or other claimants; |
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loss of revenues; and |
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the inability to commercialize our product candidates. |
We have obtained limited product liability insurance coverage for our clinical trials with a
$15.0 million annual aggregate coverage limit and additional amounts in selected foreign countries
where we are conducting clinical trials. However, our insurance coverage may not reimburse us or
may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance
coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain
insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due
to liability. We intend to expand our insurance coverage to include the sale of commercial products
if we obtain marketing approval for our product candidates in development, but we may be unable to
obtain commercially reasonable product liability insurance for any products approved for marketing.
On occasion, large
S-19
judgments have been awarded in class action lawsuits based on drugs that had
unanticipated side effects. A successful product liability claim or series of claims brought
against us could cause our stock price to fall and, if judgments exceed our insurance coverage,
could decrease our cash and adversely affect our business.
Recent proposed legislation may permit re-importation of drugs from foreign countries into the
U.S., including foreign countries where the drugs are sold at lower prices than in the U.S., which
could materially adversely affect our operating results and our overall financial condition.
Legislation has been introduced in Congress that, if enacted, would permit more widespread
re-importation of drugs from foreign countries into the U.S., which may include re-importation from
foreign countries where the drugs are sold at lower prices than in the U.S. Such legislation, or
similar regulatory changes, could decrease the price we receive for any approved products which, in
turn, could materially adversely affect our operating results and our overall financial condition.
For example, BMS markets Acetavance in Europe and other countries principally under the brand name
Perfalgan. Although Perfalgan is not labeled for sale in the U.S. and we have an exclusive license
from BMS and its licensor to develop and sell Acetavance in the U.S., it is possible that hospitals
and other users may in the future seek to import Perfalgan rather than purchase Acetavance in the
U.S. for cost-savings or other reasons. We would not receive any revenues from the importation and
sale of Perfalgan into the U.S.
Our business involves the use of hazardous materials and we and our third-party manufacturers must
comply with environmental laws and regulations, which can be expensive and restrict how we do
business.
Our third-party manufacturers activities and, to a lesser extent, our own activities involve
the controlled storage, use and disposal of hazardous materials, including the components of our
product candidates and other hazardous compounds. We and our manufacturers are subject to federal,
state and local laws and regulations governing the use, manufacture, storage, handling and disposal
of these hazardous materials. Although we believe that the safety procedures for handling and
disposing of these materials comply with the standards prescribed by these laws and regulations, we
cannot eliminate the risk of accidental contamination or injury from these materials. In the event
of an accident, state or federal authorities may curtail our use of these materials and interrupt
our business operations.
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 drug
development programs. For example, the loss of clinical trial data from completed or ongoing
clinical trials for Acetavance or Omigard could result in delays in our regulatory approval efforts
and significantly increase our costs to recover or reproduce the data. 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 and the
further development of our product candidates may be delayed.
Risks Related to Intellectual Property
The patent rights that we have in-licensed covering Acetavance are limited to a specific
intravenous formulation of acetaminophen, and our market opportunity for this product candidate
may be limited by the lack of patent protection for the active ingredient itself and other
formulations that may be developed by competitors.
The active ingredient in Acetavance is acetaminophen. Patent protection for the acetaminophen
molecule itself in the territories licensed to us, which include the U.S. and Canada, is not
available. As a result, competitors who obtain the requisite regulatory approval can offer products
with the same active ingredient as Acetavance so long as the competitors do not infringe any
process or formulation patents that we have in-licensed from BMS and its licensor, SCR Pharmatop.
We are aware of a number of third-party patents in the U.S. that claim methods of making
acetaminophen. If a supplier of the API for our Acetavance product candidate is found to infringe
any of these method patents covering acetaminophen, our supply of the API could be delayed and we
may be required to locate an alternative supplier. We are also aware of several U.S. and Canadian
patents and patent applications covering various potential injectable formulations of acetaminophen
as well as methods of making and using these potential
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formulations. For example, Injectapap, a liquid formulation of acetaminophen for intramuscular injection was approved by the FDA for the
reduction of fever in adults in March 1986, although it was subsequently withdrawn from the market
by McNeil Pharmaceutical in July 1986.
The number of patents and patent applications covering products in the same field
as Acetavance indicates that competitors have sought to develop and may seek to market competing
formulations that may not be covered by our licensed patents and patent applications. In addition,
the Canadian patent applications that we have in-licensed have yet to be examined by the Canadian
Patent Office. Thus, they may issue with claims that cover less than the corresponding in-licensed
U.S. patents, or simply not issue at all. The commercial opportunity for our Acetavance product
candidate could be significantly harmed if competitors are able to develop an alternative
formulation of acetaminophen outside the scope of our in-licensed patents.
The patent rights that we have in-licensed covering Omigard are limited in scope and limited to
specific territories.
We have an exclusive license from Migenix for Omigard in North America and Europe for the
licensed field, although currently there are issued patents only in the U.S. and certain European
countries. Canadian applications are pending; however, the claims that ultimately issue in Canada
may be narrower than the protection obtained in the U.S. and Europe or may simply not issue at all.
In addition, no patent protection has been sought in Mexico. Accordingly, the manufacture, sale and
use of Omigard in Mexico by a competitor cannot be prevented. Furthermore, there are third-party
patents covering analogs of omiganan and Migenix has patented analogs of omiganan that are not
licensed to us. It is possible that competitors having rights to these patents may develop
competing products having the same, similar or better efficacy compared to Omigard.
Furthermore, our license agreement with Migenix may be construed to cover only the use of
Omigard and other formulations of omiganan for the licensed field, which is the topical
administration to a burn or a surgical wound site for the treatment of burn-related, surgical
wound-related infections and the topical administration to a device or the site around the device
for the treatment of device-related infections. Thus, Migenix or third-party licensees of Migenix
may be able to market Omigard for other uses, including treatment of non-surgery related wound
infections. We may be unable to prevent physicians from using any such competitive Omigard product
off-label for the field licensed to us.
We depend on our licensors for the maintenance and enforcement of our intellectual property and
have limited control, if any, over the amount or timing of resources that our licensors devote on
our behalf.
We depend on our licensors, BMS, SCR Pharmatop, and Migenix, to protect the proprietary rights
covering Acetavance and Omigard. Regarding Acetavance, either BMS or its licensor, SCR Pharmatop,
depending on the patent or application, is responsible for maintaining issued patents and
prosecuting patent applications. Regarding Omigard, Migenix is responsible for maintaining issued
patents and prosecuting patent applications. We have limited, if any, control over the amount or timing of resources that our licensors devote
on our behalf or the priority they place on maintaining these patent rights and prosecuting these
patent applications to our advantage. SCR Pharmatop is under a contractual obligation to BMS to
diligently prosecute their patent applications and allow BMS the opportunity to consult, review and
comment on patent office communications. However, we cannot be sure that SCR Pharmatop will perform
as required. Should BMS decide it no longer wants to maintain any of the patents licensed to us,
BMS is required to afford us the opportunity to do so at our expense. However, we cannot be sure
that BMS will perform as required. If BMS does not perform, and if we do not assume the maintenance
of the licensed patents in sufficient time to make required payments or filings with the
appropriate governmental agencies, we risk losing the benefit of all or some of those patent
rights. For patents and applications licensed from Migenix, Migenix is obligated to use
commercially reasonable efforts to obtain and maintain patent rights covering Omigard in North
America and Europe. If Migenix intends to abandon prosecution or maintenance of any patents or
applications, they are obligated to notify us, and at that time, we will be granted an opportunity
to maintain and prosecute the patents and applications at our expense. In such a case, Migenix is
required to transfer all necessary rights and responsibilities to facilitate our maintenance and
prosecution of the patents and applications. Similar to BMS, however, we cannot be certain that
Migenix will perform its contractual obligations as required or that we will be able to adequately
assume the prosecution or maintenance of the Omigard-related patents and applications.
S-21
As part of a financing transaction, Migenix has pledged as collateral to its lenders the
patents and patent applications covering Omigard. While we believe our license agreement with
Migenix would survive any foreclosure on these patents and patent applications, we cannot be sure
that the lenders will have adequate expertise or resources to properly perform Migenix obligations
to us under the license agreement, including maintaining and prosecuting the patents and patent
applications.
While we intend to take actions reasonably necessary to enforce our patent rights, we depend,
in part, on our licensors to protect a substantial portion of our proprietary rights. In the case
of the Acetavance patents, BMS has the first right to prosecute a third-party infringement of the
SCR Pharmatop patents, and has the sole right to prosecute third-party infringement of the BMS
patents. We will have the ability to cooperate with BMS in third-party infringement suits involving
the SCR Pharmatop patents. It is possible that SCR Pharmatop or BMS could take some action or fail
to take some action that could harm the SCR Pharmatop patents. In certain instances, we may be
allowed to pursue the infringement claim ourselves. With respect to Omigard, we have the first
right to prosecute a third-party for infringement of the in-licensed Migenix patents provided the
infringing activities are in North America or Europe and relate primarily to the licensed field of
use. Migenix is obligated to reasonably cooperate with any such suit.
Our licensors may also be notified of alleged infringement and be sued for infringement of
third-party patents or other proprietary rights. We may have limited, if any, control or
involvement over the defense of these claims, and our licensors could be subject to injunctions and
temporary or permanent exclusionary orders in the U.S. or other countries. Our licensors are not
obligated to defend or assist in our defense against third-party claims of infringement. We have
limited, if any, control over the amount or timing of resources, if any, that our licensors devote
on our behalf or the priority they place on defense of such third-party claims of infringement.
Finally, Migenix is not obligated to defend or assist in our defense of a third-party infringement
suit relating to our Omigard product candidate; however, Migenix has the right to control the
defense and settlement that relates to the validity and enforceability of claims in the in-licensed
Migenix patents.
For a third-party challenge to the SCR Pharmatop in-licensed patents relating to Acetavance,
we will have some ability to participate in either SCR Pharmatops or BMS defense thereof. In the
case that neither party elects to defend the third-party challenge, we may have the opportunity to
defend it. For a third-party challenge to the in-licensed BMS patents relating to Acetavance, BMS
has the sole right to defend such challenge. If it chooses not to, we may have the right to
renegotiate or terminate the license regarding the in-licensed BMS patents.
Because of the uncertainty inherent in any patent or other litigation involving proprietary
rights, we or our licensors may not be successful in defending claims of intellectual property
infringement by third parties, which could have a material adverse affect on our results of
operations. Regardless of the outcome of any litigation, defending the litigation may be expensive,
time-consuming and distracting to management.
Because it is difficult and costly to protect our proprietary rights, we may not be able to ensure
their protection.
Our commercial success will depend in part on obtaining and maintaining patent protection and
trade secret protection for Acetavance, Omigard or any other product candidates that we may
in-license or acquire and the methods we use to manufacture them, as well as successfully defending
these patents against third-party challenges. We will only be able to protect our technologies from
unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets
cover them.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
involve complex legal and factual questions for which important legal principles remain unresolved.
No consistent policy regarding the breadth of claims allowed in pharmaceutical or biotechnology
patents has emerged to date in the U.S. The patent situation outside the U.S. is even more
uncertain. Changes in either the patent laws or in interpretations of patent laws in the U.S. and
other countries may diminish the value of our intellectual property. Accordingly, we cannot predict
the breadth of claims that may be allowed or enforced in our patents or in third-party patents.
The degree of future protection for our proprietary rights is uncertain, because legal means
afford only limited protection and may not adequately protect our rights or permit us to gain or
keep our competitive advantage. For example:
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our licensors might not have been the first to make the inventions covered by each of our
pending patent applications and issued patents; |
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our licensors might not have been the first to file patent applications for these
inventions; |
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others may independently develop similar or alternative technologies or duplicate any of
our product candidates or technologies; |
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it is possible that none of the pending patent applications licensed to us will result in
issued patents; |
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the issued patents covering our product candidates may not provide a basis for
commercially viable active products, may not provide us with any competitive advantages, or
may be challenged by third parties; |
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we may not develop additional proprietary technologies that are patentable; or |
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patents of others may have an adverse effect on our business. |
Patent applications in the U.S. are maintained in confidence for at least 18 months after
their earliest effective filing date. Consequently, we cannot be certain that our licensors were
the first to invent or the first to file patent applications on some of our product candidates. In
the event that a third party has also filed a U.S. patent application relating to our product
candidates or a similar invention, we may have to participate in interference proceedings declared
by the U.S. Patent and Trademark Office to determine priority of invention in the U.S. 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 U.S. patent position. Furthermore, we may not have
identified all U.S. and foreign patents or published applications that affect our business either
by blocking our ability to commercialize our drugs or by covering similar technologies that affect
our drug 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.
We also rely on trade secrets to protect our technology, particularly where we do not believe
patent protection is appropriate or obtainable. However, trade secrets are difficult to protect.
While we use reasonable efforts to protect our trade secrets, our licensors, employees,
consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our information to competitors. Enforcing a
claim that a third party illegally obtained and is using our trade secrets is expensive and time
consuming, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes
less willing to protect trade secrets. Moreover, our competitors may independently develop
equivalent knowledge, methods and know-how.
If our licensors or we fail to obtain or maintain patent protection or trade secret protection
for Acetavance, Omigard or any other product candidate we may in-license or acquire, third parties
could use our proprietary information, which could impair our ability to compete in the market and
adversely affect our ability to generate revenues and achieve profitability.
If we are sued for infringing intellectual property rights of third parties, it will be costly and
time consuming, and an unfavorable outcome in any litigation would harm our business.
Our ability to develop, manufacture, market and sell Acetavance, Omigard or any other product
candidates that we may in-license or acquire depends upon our ability to avoid infringing the
proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent
applications, which are owned by third parties, exist in the general fields of pain treatment and
prevention of infections and cover the use of numerous compounds and formulations in our targeted
markets. For instance, there is a patent in force in various European countries, with claims that,
if valid, may be broad enough in scope to cover the formulation of our Omigard product candidate.
It is
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possible that we may determine it prudent to seek a license to this European patent in order
to avoid potential litigation and other disputes. We cannot be sure that a license would be
available to us on commercially reasonable terms, or at all. Similarly, there is a patent
application pending in the U.S. that corresponds to the European patent. Because this patent
application has neither published nor issued, it is too early to tell if the claims of this
application will present similar issues for Omigard in the U.S. There is also a patent application
pending in Canada that corresponds to the European patent. Because this patent application has not
issued, it is too early to tell if the claims of this application will present similar issues for
Omigard in Canada. However, similar to the European patent, if the U.S. or Canadian patent
applications issue with a scope that is broad enough to cover our Omigard product candidate and we
are unable to assert successful defenses to any patent claims, we may be unable to commercialize
Omigard, or may be required to expend substantial sums to obtain a license to the other partys
patent. While we believe there may be multiple grounds to challenge the validity of the European
patent, and these grounds may be applicable to the U.S. and Canadian applications should they issue
as patents, the outcome of any litigation relating to this European patent and the U.S. and
Canadian patent applications, or any other patents or patent applications, is uncertain and
participating in such litigation would be expensive, time-consuming and distracting to management.
Because of the uncertainty inherent in any patent or other litigation involving proprietary rights,
we and Migenix may not be successful in defending intellectual property claims by third parties,
which could have a material adverse affect on our results of operations. Regardless of the outcome
of any litigation, defending the litigation may be expensive, time-consuming and distracting to
management. In addition, because patent applications can take many years to issue, there may be
currently pending applications, unknown to us, which may later result in issued patents
that Acetavance or Omigard may infringe. There could also be existing patents of which we are not
aware that Acetavance or Omigard may inadvertently infringe.
There is a substantial amount of litigation involving patent and other intellectual property
rights in the biotechnology and biopharmaceutical industries generally. If a third party claims
that we infringe on their products or technology, we could face a number of issues, including:
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infringement and other intellectual property claims which, with or without merit, can be
expensive and time consuming to litigate and can divert managements attention from our core
business; |
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substantial damages for past infringement which we may have to pay if a court decides
that our product infringes on a competitors patent; |
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a court prohibiting us from selling or licensing our product unless the patent holder
licenses the patent to us, which it is not required to do; |
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if a license is available from a patent holder, we may have to pay substantial royalties
or grant cross licenses to our patents; and |
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redesigning our processes so they do not infringe, which may not be possible or could
require substantial funds and time. |
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade
secrets of their former employers.
As is common in the biotechnology and pharmaceutical industry, we employ individuals who were
previously employed at other biotechnology or pharmaceutical companies, including our competitors
or potential competitors. Although no claims against us are currently pending, we may be subject to
claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets
or other proprietary information of their former employers. Litigation may be necessary to defend
against these claims. Even if we are successful in defending against these claims, litigation could
result in substantial costs and be a distraction to management.
Risks Related to Our Finances and Capital Requirements
We have incurred significant operating losses since our inception and anticipate that we will
incur continued losses for the foreseeable future.
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We are a development stage company with a limited operating history. We have focused primarily
on in-licensing and developing our two product candidates, Acetavance and Omigard, with the goal of
supporting regulatory approval for these product candidates. We have incurred losses in each year
since our inception in May 2004. Net losses were $52.2 million and $7.7 million for the years ended
December 31, 2006 and 2005, respectively. As of September 30, 2007, we had an accumulated deficit
of $100.2 million. These losses, among other things, have had and will continue to have an adverse
effect on our stockholders equity and working capital. We expect our development expenses as well
as clinical product manufacturing expenses to increase in connection with our ongoing and planned
Phase III clinical trials and any additional clinical trials that we may be required to conduct in
order to support regulatory approvals, additional indications or dosages for our product
candidates. In addition, if we obtain regulatory approval for Acetavance or Omigard, we expect to
incur significant sales, marketing and outsourced manufacturing expenses as well as continued
development expenses. 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 developing pharmaceutical products, we are unable to predict the extent of any
future losses or when we will become profitable, if at all.
We currently have no source of revenue and may never be profitable.
Our ability to become profitable depends upon our ability to generate revenue. To date, we
have not generated any revenue from our development stage product candidates, and we do not know
when, or if, we will generate any revenue. Our ability to generate revenue depends on a number of
factors, including, but not limited to, our ability to:
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successfully complete our ongoing and future clinical trials for Acetavance and Omigard; |
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obtain regulatory approval for either of our two product candidates or any other product
candidate that we may in-license or acquire; |
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assuming these regulatory approvals are received, manufacture commercial quantities of
our product candidates at acceptable cost levels; and |
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successfully market and sell any approved products. |
Even if one or more of our product candidates is approved for commercial sale, we anticipate
incurring significant costs associated with commercializing any approved product. We also do not
anticipate that we will achieve profitability for at least several years after generating material
revenues, if ever. If we are unable to generate revenues, we will not become profitable and may be
unable to continue operations without continued funding.
Our short operating history makes it difficult to evaluate our business and prospects.
We were incorporated in May 2004 and have only been conducting operations with respect to
our Acetavance product candidate since March 2006 and our Omigard product candidate since July
2004. Our operations to date have been limited to organizing and staffing our company, in-licensing
our two product candidates and conducting product development activities, including clinical trials
and manufacturing development activities, for our two product candidates. We have not yet
demonstrated an ability to obtain regulatory approval for or successfully commercialize a product
candidate. Consequently, any predictions about our future performance may not be as accurate as
they could be if we had a history of successfully developing and commercializing pharmaceutical
products.
We will need additional funding and may be unable to raise capital when needed, which would force
us to delay, reduce or eliminate our product development programs or commercialization efforts.
Developing products for use in the hospital setting, conducting clinical trials, establishing
outsourced manufacturing relationships and successfully manufacturing and marketing drugs that we
may develop is expensive. We will need to raise additional capital to:
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fund our operations and continue to conduct adequate and well-controlled clinical trials
to provide clinical data to support regulatory approval of marketing applications; |
S-25
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continue our development activities; |
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qualify and outsource the commercial-scale manufacturing of our products under cGMP; and |
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commercialize Acetavance, Omigard or any other product candidates that we may in-license
or acquire, if any of these product candidates receive regulatory approval. |
We believe that our existing cash and cash equivalents, together with the net proceeds from
this offering, will be sufficient to meet our projected operating requirements, at a minimum, for
the next 12 months. We have based this estimate on assumptions that may prove to be wrong and we
could spend our available financial resources faster than we currently expect. Our future funding
requirements will depend on many factors, including, but not limited to:
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the rate of progress and cost of our clinical trials and other product development
programs for Acetavance, Omigard and any other product candidates that we may in-license or
acquire; |
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the costs of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights associated with our product candidates; |
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the cost and timing of completion of an outsourced commercial manufacturing supply for
each product candidate; |
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the costs and timing of regulatory approval; |
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the costs of establishing sales, marketing and distribution capabilities; |
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the effect of competing technological and market developments; and |
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the terms and timing of any collaborative, licensing, co-promotion or other arrangements
that we may establish. |
Future capital requirements will also depend on the extent to which we acquire or invest in
additional complementary businesses, products and technologies, but we currently have no
commitments or agreements relating to any of these types of transactions.
Until we can generate a sufficient amount of product revenue, if ever, we expect to finance
future cash needs through public or private equity offerings, debt financings or corporate
collaboration and licensing arrangements, as well as through interest income earned on cash and
investment balances. We cannot be certain that additional funding will be available on acceptable
terms, or at all. If adequate funds are not available, we may be required to delay, reduce the
scope of or eliminate one or more of our development programs or our commercialization efforts.
Our quarterly operating results may fluctuate significantly.
We expect our operating results to be subject to quarterly fluctuations. Our net loss and
other operating results will be affected by numerous factors, including:
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the timing of milestone payments required under our license agreements for Acetavance and
Omigard; |
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our execution of other collaborative, licensing or similar arrangements, and the timing
of payments we may make or receive under these arrangements; |
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our addition or termination of clinical trials or funding support; |
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variations in the level of expenses related to our two existing product candidates or
future development programs; |
S-26
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any intellectual property infringement lawsuit in which we may become involved; |
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regulatory developments affecting our product candidates or those of our competitors; and |
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if either of our product candidates receives regulatory approval, the level of underlying
hospital demand for our product candidates and wholesalers buying patterns. |
If our quarterly or annual operating results fall below the expectations of investors or
securities analysts, the price of our common stock could decline substantially. Furthermore, any
quarterly or annual fluctuations in our operating results may, in turn, cause the price of our
stock to fluctuate substantially. 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.
Raising additional funds by issuing securities may cause dilution to existing stockholders and
raising funds through lending and licensing arrangements may restrict our operations or require us
to relinquish proprietary rights.
To the extent that we raise additional capital by issuing equity securities, our existing
stockholders ownership will be diluted. If we raise additional funds through 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. Any
debt financing we enter into may involve covenants that restrict our operations. These restrictive
covenants may include limitations on additional borrowing and specific restrictions on the use of
our assets as well as prohibitions on our ability to create liens, pay dividends, redeem our stock
or make investments. For example, in February 2006, we entered into a $7.0 million loan and
security agreement with Silicon Valley Bank and Oxford Finance Corporation, and in December 2007,
we amended this agreement and secured an additional $15.0 million loan from the same parties and
Merrill Lynch Capital. These loan and security agreements contain a variety of affirmative and
negative covenants, including required financial reporting, limitations on the disposition of
assets other than in the ordinary course of business, limitations on the incurrence of additional
debt and other requirements. To secure our performance of our obligations under the loan and
security agreement, we pledged substantially all of our assets other than intellectual property
assets, to the lenders. Our failure to comply with the covenants in the loan and security agreement
could result in an event of default that, if not cured or waived, could result in the acceleration
of all or a substantial portion of our debt.
We will continue to incur significant increased costs as a result of operating as a public
company, and our management will be required to devote substantial time to new compliance
initiatives.
As a public company, we incur significant legal, accounting and other expenses under the
Sarbanes-Oxley Act of 2002, as well as rules subsequently implemented by the Commission and The
NASDAQ Stock Market LLC. These rules impose various requirements on public companies, including
requiring establishment and maintenance of effective disclosure and financial controls and changes
in corporate governance practices. Our management and other personnel have devoted and will
continue to devote a substantial amount of time to these compliance initiatives. Moreover, these
rules and regulations increase our legal and financial compliance costs and make some activities
more time-consuming and costly. For example, these rules and regulations make it more difficult and
more expensive for us to obtain director and officer liability insurance, and we may be required to
accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or
similar coverage. As a result, it may be more difficult for us to attract and retain qualified
persons to serve on our board of directors, our board committees or as executive officers.
The Sarbanes-Oxley Act of 2002 requires, among other things, that we maintain effective
internal controls for financial reporting and disclosure controls and procedures. In particular,
commencing in fiscal 2007, we must perform system and process evaluation and testing of our
internal controls over financial reporting to allow management and our independent registered
public accounting firm to report on the effectiveness of our internal controls over financial
reporting, as required by Section 404 of the Sarbanes-Oxley Act. Our testing, or the subsequent
testing by our independent registered public accounting firm, may reveal deficiencies in our
internal controls over financial reporting that are deemed to be material weaknesses. Our
compliance with Section 404 will
S-27
require that we incur substantial accounting expense and expend significant management
efforts. We currently do not have an internal audit group, and we may need to hire additional
accounting and financial staff with appropriate public company experience and technical accounting
knowledge. Moreover, if we are not able to comply with the requirements of Section 404 in a timely
manner, or if we or our independent registered public accounting firm identify deficiencies in our
internal controls over financial reporting that are deemed to be material weaknesses, the market
price of our stock could decline and we could be subject to sanctions or investigations by Nasdaq,
the Commission or other regulatory authorities, which would require additional financial and
management resources.
Risks Relating to Securities Markets and Investment in Our Stock
There may not be a viable public market for our common stock.
Our common stock had not been publicly traded prior to our initial public offering, which was
completed in October 2006, and an active trading market may not develop or be sustained. We have
never declared or paid any cash dividends on our capital stock, and we currently intend to retain
all available funds and any future earnings to support operations and finance the growth and
development of our business and do not intend to pay cash dividends on our common stock for the
foreseeable future. Furthermore, our loan and security agreement with Silicon Valley Bank and
Oxford Finance Corporation restricts our ability to pay cash dividends. Therefore, investors will
have to rely on appreciation in our stock price and a liquid trading market in order to achieve a
gain on their investment. The market prices for securities of biotechnology and pharmaceutical
companies have historically been highly volatile, and the market has from time to time experienced
significant price and volume fluctuations that are unrelated to the operating performance of
particular companies. Since our initial public offering in October 2006 through January 31, 2008,
the trading prices for our common stock ranged from a high of $18.55 to a low of $5.01.
Future sales of our common stock may cause our stock price to decline.
Persons who were our stockholders prior to the sale of shares in our initial public offering
continue to hold a substantial number of shares of our common stock that they may now able to sell
in the public market. Significant portions of these shares are held by a small number of
stockholders. Sales by our current stockholders of a substantial number of shares, or the
expectation that such sales may occur, could significantly reduce the market price of our common
stock. Moreover, the holders of a substantial number of shares of common stock may have rights,
subject to certain conditions, to require us to file registration statements to permit the resale
of their shares in the public market or to include their shares in registration statements that we
may file for ourselves or other stockholders.
We have also registered all common stock that we may issue under our employee benefits plans.
As a result, these shares can be freely sold in the public market upon issuance, subject to
restrictions under the securities laws. In addition, our directors and executive officers may in
the future establish programmed selling plans under Rule 10b5-1 of the Securities Exchange Act of
1934, as amended, or the Exchange Act, for the purpose of effecting sales of our common stock. If
any of these events cause a large number of our shares to be sold in the public market, the sales
could reduce the trading price of our common stock and impede our ability to raise future capital.
We expect that the price of our common stock will fluctuate substantially.
The market price of our common stock is likely to be highly volatile and may fluctuate
substantially due to many factors, including:
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the results from our clinical trial programs, including our ongoing Phase III clinical
program for Acetavance and our ongoing Phase III clinical trial of Omigard; |
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the results of clinical trial programs for Acetavance and Omigard being performed by
others; |
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FDA or international regulatory actions, including failure to receive regulatory approval
for any of our product candidates; |
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failure of any of our product candidates, if approved, to achieve commercial success; |
S-28
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announcements of the introduction of new products by us or our competitors; |
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market conditions in the pharmaceutical and biotechnology sectors; |
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developments concerning product development results or intellectual property rights of
others; |
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litigation or public concern about the safety of our potential products; |
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actual and anticipated fluctuations in our quarterly operating results; |
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deviations in our operating results from the estimates of securities analysts or other
analyst comments; |
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additions or departures of key personnel; |
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third-party coverage and reimbursement policies; |
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developments concerning current or future strategic collaborations; and |
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discussion of us or our stock price by the financial and scientific press and in online
investor communities. |
The realization of any of the risks described in these Risk Factors could have a dramatic
and material adverse impact on the market price of our common stock. In addition, class action
litigation has often been instituted against companies whose securities have experienced periods of
volatility in market price. Any such litigation brought against us could result in substantial
costs and a diversion of managements attention and resources, which could hurt our business,
operating results and financial condition.
Our executive officers and directors and their affiliates may exercise control over stockholder
voting matters in a manner that may not be in the best interests of all of our stockholders.
As of September 30, 2007, our executive officers and directors and their affiliates together
controlled approximately 41% of our outstanding common stock. As a result, these stockholders will
collectively be able to significantly influence all matters requiring approval of our stockholders,
including the election of directors and approval of significant corporate transactions. The
concentration of ownership may delay, prevent or deter a change in control of our company even when
such a change may be in the best interests of all stockholders, could deprive our stockholders of
an opportunity to receive a premium for their common stock as part of a sale of our company or our
assets, and might affect the prevailing market price of our common stock.
Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a
change of control which could limit the market price of our common stock and may prevent or
frustrate attempts by our stockholders to replace or remove our current management.
Our amended and restated certificate of incorporation and amended and restated bylaws contain
provisions that could delay or prevent a change of control of our company or changes in our board
of directors that our stockholders might consider favorable. Some of these provisions include:
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a board of directors divided into three classes serving staggered three-year terms, such
that not all members of the board will be elected at one time; |
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a prohibition on stockholder action through written consent; |
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a requirement that special meetings of stockholders be called only by the chairman of the
board of directors, the chief executive officer, the president or by a majority of the total
number of authorized directors; |
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advance notice requirements for stockholder proposals and nominations; |
S-29
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a requirement of approval of not less than 66 2/3% of all outstanding shares of our
capital stock entitled to vote to amend any bylaws by stockholder action, or to amend
specific provisions of our certificate of incorporation; and |
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the authority of the board of directors to issue preferred stock on terms determined by
the board of directors without stockholder approval. |
In addition, we are governed by the provisions of Section 203 of the Delaware General
Corporate Law, which may prohibit certain business combinations with stockholders owning 15% or
more of our outstanding voting stock. These and other provisions in our amended and restated
certificate of incorporation, amended and restated bylaws and Delaware law could make it more
difficult for stockholders or potential acquirers to obtain control of our board of directors or
initiate actions that are opposed by the then-current board of directors, including to delay or
impede a merger, tender offer or proxy contest involving our company. Any delay or prevention of a
change of control transaction or changes in our board of directors could cause the market price of
our common stock to decline.
We have never paid dividends on our capital stock, and we do not anticipate paying any cash
dividends in the foreseeable future.
We have paid no cash dividends on any of our classes of capital stock to date and we currently
intend to retain our future earnings, if any, to fund the development and growth of our business.
We do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Furthermore, our loan and security agreement with Silicon Valley Bank and Oxford Finance
Corporation restricts our ability to pay dividends. As a result, capital appreciation, if any, of
our common stock will be your sole source of gain for the foreseeable future.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The stock markets have from time to time experienced significant price and volume fluctuations
that have affected the market prices for the common stock of pharmaceutical companies. These broad
market fluctuations may cause the market price of our common stock to decline. In the past,
securities class action litigation has often been brought against a company following a decline in
the market price of its securities. This risk is especially relevant for us because biotechnology
and biopharmaceutical companies have experienced significant stock price volatility in recent
years. We may become involved in this type of litigation in the future. Litigation often is
expensive and diverts managements attention and resources, which could adversely affect our
business.
Our management team may invest or spend the proceeds of this offering in ways with which you may
not agree or in ways which may not yield a return.
Our management will have broad discretion over the use of proceeds from this offering.
The net proceeds from this offering will be used (i) to fund clinical and preclinical development
of our product candidates, including, but not limited to (A) the funding in the entirety of one or
more Phase III clinical trials to support the safety and efficacy of Acetavance in acute pain, in
addition to the CPI-APA-301 trials, but only if we, in our reasonable judgment, decide to conduct
such trial(s) following any communications between us and the FDA,
and (B) the review of the CPI-APA-304 trial and funding of any modifications, revisions or other
changes to such trial as appropriate, and (ii) for general corporate purposes (only to the extent
the items described in (i)(A) and (B) above have been fully funded or amounts required for those
items have been reserved by us). Subject to the receipt of certain approvals, we may also use a
portion of the net proceeds to in-license, acquire or invest in complementary businesses or
products. We have no present understandings, commitments or agreements with respect to any such
in-licenses, acquisitions or investments and no portion of the net proceeds has been allocated for
any specific transaction. Our management will have considerable discretion in the application of
the net proceeds, and you will not have the opportunity, as part of your investment decision, to
assess whether the proceeds are being used appropriately. The net proceeds may be used for
corporate purposes that do not increase our operating results or market value. Until the net
proceeds are used, they may be placed in investments that do not produce significant income or that
lose value.
S-30
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, including the information we incorporate by reference, contains
forward-looking statements that involve substantial risks and uncertainties. All statements, other
than statements of historical fact, included in this prospectus supplement regarding our strategy,
future operations, future financial position, future revenue, projected costs, prospects, plans and
objectives of management are forward-looking statements. The words anticipate, believe,
estimate, expect, hope, intend, may, plan, project, will, would and similar
expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements and you should not place undue reliance on
our forward-looking statements. Actual results may differ materially from those set forth in this
prospectus supplement, including the information we incorporate by reference, due to the risks and
uncertainties inherent in our business, including, without limitation, the following risks: we are
largely dependent on the success of our only two product candidates, Acetavance and Omigard, and we
cannot be certain that our ongoing and planned clinical development programs will be successful, or
sufficient to support NDAs, or that either product candidate will receive regulatory approval or be
successfully commercialized; delays in the commencement, enrollment or completion of clinical
testing for either of our product candidates, or significant issues regarding the adequacy of our
clinical trial designs or the execution or success of our clinical trials, could result in
increased costs to us and delay or limit our ability to obtain regulatory approval; the outcome of
final analyses of data from our clinical trials of Acetavance or Omigard may vary from our initial
analyses, and the FDA may not agree with our interpretation of these results; ongoing or planned
clinical trials of Acetavance or Omigard may produce negative or inconclusive results, or may be
inconsistent with previous clinical trial results, and we may decide, or the FDA may require us, to
conduct additional clinical trials or to modify our ongoing clinical trials; even if our product
candidates are approved by regulatory authorities, the market potential for pain, fever, local
catheter site infections and other target markets may be less than anticipated, and we expect
intense competition in the hospital marketplace for our targeted indications; unexpected adverse
side effects or inadequate therapeutic efficacy of Acetavance or Omigard could delay or prevent
regulatory approval or commercialization of our product candidates, or result in recalls or product
liability claims against us; delays or quality issues with respect to the completion of required
pre-commercialization manufacturing development activities for our product candidates, including
the completion of adequate stability data, could result in increased costs to us and delay or limit
our clinical trials and our ability to obtain regulatory approval; the patent rights that we have
in-licensed covering Acetavance are limited to a specific intravenous formulation of acetaminophen,
and our market opportunity for this product candidate may be limited by the lack of patent
protection for the active ingredient itself and other formulations that may be developed by
competitors; we will require 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 development programs and
commercialization efforts; and we may not be able to maintain patent protection for our products
and to commercialize our products without infringing the patent rights of others. Such statements
include, but are not limited to, statements preceded by, followed by or that otherwise include the
words believes, expects, anticipates, intends, estimates, projects, can, could,
may, will, would or similar expressions. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in Section 21E of the Private Securities
Litigation Reform Act of 1995. You should not rely unduly on these forward-looking statements,
which speak only as of the date on which they were made. We undertake no obligation to update
publicly or revise any forward-looking statements, whether as a result of new information, future
events or otherwise, unless required by law.
USE OF PROCEEDS
We estimate that the net proceeds from the sale of the shares of common stock we are offering
will be approximately $49.0 million after deducting our
estimated offering costs, which we
expect to be approximately $300,000 and which include legal, accounting and printing costs and
various other fees associated with registering and listing the shares of common stock to be sold in
this offering. The net proceeds from the sale of the shares of common
stock we are offering may be reduced to approximately
$42.7 million after deducting our estimated offering costs,
pursuant to Nasdaq Marketplace Rule 4350(i)(1)(B) limitations,
pending the determination of the applicability of such rule prior to
the closing of the offering.
We expect to use the net proceeds from this sale of shares of common stock (i) to fund
clinical and preclinical development of our product candidates, including, but not limited to (A)
the funding in the entirety of one or more Phase III clinical trials to support the safety and
efficacy of Acetavance in acute pain, in addition to the CPI-APA-301 trials, but only if we, in
our reasonable judgment, decide to conduct such
trial(s) following any communications between us
and the U.S. Food and Drug Administration, and (B) the review of the CPI-APA-304 trial and funding
of any modifications, revisions or other changes to such trial as appropriate, and (ii) for general
corporate purposes (only to the extent the items described in (i)(A) and (B) above have been fully
funded or amounts required for those items have been reserved by us). While we have estimated the
particular uses for the net proceeds to be received by us from the sale of the shares of common
stock, we cannot specify these uses with certainty. Accordingly, our management will have broad
discretion in the application of the proceeds, and investors will be relying on the judgment of our
management regarding the application of the proceeds of this offering. Pending these uses, we plan
to invest the net proceeds in short-term, interest bearing obligations, investment grade
instruments, money market funds, certificates of deposit or direct or guaranteed obligations of the
United States. The goal with respect to the investment of these net proceeds is capital
preservation and liquidity so that such funds are readily available to fund our research and
development operations.
S-31
DILUTION
If you invest in our common stock in this offering, your ownership interest will be diluted to
the extent of the difference between the offering price per share and the net tangible book value
per share after this offering. Our net tangible book value as of September 30, 2007 was
approximately $41.0 million, or approximately $1.41 per share of common stock. Net tangible book
value per share represents total tangible assets less total liabilities, divided by the number of
shares of common stock outstanding. Dilution in net tangible book value per share represents the
difference between the amount per share paid by purchasers of shares of common stock in this
offering and the net tangible book value per share of common stock immediately after the closing of
this offering.
After giving effect to the sale of the shares of common stock at an
offering price of $5.34 per share, after deducting estimated offering
costs payable by us, our net tangible book value
as of September 30, 2007 would have been approximately
$90.1 million, or $2.35 per share of common
stock. This represents an immediate increase in net tangible book
value of $0.94 per share to
existing stockholders and an immediate dilution of $2.99 per share to new investors purchasing
shares of common stock in this offering at the offering price.
The following table illustrates this dilution on a per share basis:
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Offering price per share |
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$ |
5.34 |
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Net tangible book value per share as of September 30, 2007 |
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1.41 |
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Increase per share attributable to this offering |
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0.94 |
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As adjusted net tangible book value per share after this offering |
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2.35 |
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Dilution per share to new investors |
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$ |
2.99 |
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The calculations above are based on 29,108,730 shares of common stock outstanding as of
September 30, 2007. This number excludes, as of September 30, 2007:
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2,422,850 shares of common stock issuable upon the exercise of stock options
outstanding at a weighted-average exercise price of $6.36 per share; and |
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an aggregate of 1,439,104 shares of common stock reserved for future issuance under
our 2006 Equity Incentive Plan. |
PLAN OF DISTRIBUTION
We
are selling 9,240,307 shares of our common stock under this prospectus supplement directly
to certain investors at a price of $5.34 per share.
We
currently anticipate that the closing of the sale of the 9,240,307 shares of our common
stock under this prospectus supplement will take place on or about
February 20, 2008. The total number of shares to be sold in the
offering may be reduced to approximately 8,056,716 pursuant to Nasdaq
Marketplace Rule 4350(i)(1)(B) limitations, pending the determination
of the applicability of such rule prior to the closing of the
offering. On the
closing date, we will issue the shares of common stock to the investors and we will receive funds
in the amount of the aggregate purchase price.
We
have entered into common stock purchase agreements dated as of
February 14, 2008, with
each of the investors relating to the sale of our common stock offered under this prospectus
supplement.
The transfer agent for our common stock is American Stock Transfer & Trust Company. Our
common stock is traded on The Nasdaq Global Market under the symbol CADX.
We are not offering shares of our common stock under this prospectus supplement through a
placement agent, underwriter or securities broker or dealer. However, we may offer and sell
pursuant to one or more additional prospectus supplements, from time to time, shares of our common
stock for an aggregate offering price not to
S-32
exceed $100,000,000, less the amount of shares offered pursuant to this prospectus supplement,
in one or more underwritten or other public offerings and at prices and on terms that we determine
at the time of such offering. In no event will the total amount of compensation paid to any
underwriter, securities broker or dealer or any member of the Financial Industry Regulatory
Authority, exceed 8% of the maximum gross proceeds of such offering.
LEGAL MATTERS
The validity of the issuance of the shares of our common stock being offered hereby will be
passed upon for us by Latham & Watkins LLP, San Diego, California.
EXPERTS
The
financial statements of Cadence Pharmaceuticals, Inc. appearing in
the Companys Annual Report on
Form 10-K for the year ended December 31, 2006 have been audited by Ernst & Young LLP, independent
registered public accounting firm, as set forth in their report thereon and incorporated herein by
reference. Such financial statements are incorporated herein by reference in reliance upon such
report given on the authority of such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Exchange Act. Therefore, we file
annual, quarterly and current reports, proxy statements and other information with the Commission.
We have filed with the Commission a registration statement on Form S-3 under the Securities Act of
1933, as amended, with respect to the shares of common stock we are offering under this prospectus
supplement and the accompanying prospectus. This prospectus supplement and the accompanying
prospectus do not contain all of the information set forth in the registration statement and the
exhibits to the registration statement. For further information with respect to us and the
securities we are offering under this prospectus supplement and the accompanying prospectus, we
refer you to the registration statement and the exhibits and schedules filed as a part of the
registration statement. You may read and copy the registration statement, as well as our reports,
proxy and information statements and other information at the Commissions Public Reference Room
located at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330
for further information on the Public Reference Room. The Commission maintains an Internet site at
www.sec.gov that contains reports, proxy and information statements and other information regarding
issuers that file electronically with the Commission.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The Commission allows us to incorporate by reference the information that we file with it,
which means that we can disclose important information to you by referring you to those documents
instead of having to repeat the information in this prospectus supplement. The information
incorporated by reference is an important part of this prospectus supplement and the accompanying
prospectus. To the extent that any statement that we make in this prospectus supplement is
inconsistent with the statements made in the accompanying prospectus or the information
incorporated by reference, the statements made in the accompanying prospectus or the documents
incorporated by reference are deemed modified or superseded by the statements made in this
prospectus supplement, while information that we file later with the Commission will automatically
update and supersede this information.
We incorporate by reference the documents listed below (except as modified by this prospectus
supplement and the accompanying prospectus) and any future filings we will make with the Commission
under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus
supplement and prior to the termination of this offering:
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our annual report on Form 10-K for the year ended December 31, 2006, filed on March
28, 2007; |
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our quarterly reports on Form 10-Q for the quarterly periods ended March 31, 2007
(filed on May 15, 2007), June 30, 2007 (filed on August 14, 2007) and September 30, 2007
(filed on November 14, 2007); |
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our current reports on Form 8-K filed on January 30, 2007, March 28, 2007, April 20,
2007, July 23, 2007, December 3, 2007, December 17, 2007 and February 4, 2008 (other
than information furnished under Item 7.01 rather than filed therewith); |
S-33
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our definitive proxy statement on Schedule 14A filed on April 30, 2007; |
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the description of our common stock contained in our registration statement on
Form 8-A (File No. 001-33103), filed on October 19, 2006; and |
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all documents filed by us with the Commission under Section 13(a), 13(c), 14 or 15(d)
of the Exchange Act after the date of this prospectus and before termination of this
offering. |
To the extent that any information contained in any current report on Form 8-K or any exhibit
thereto, was furnished, rather than filed with the Commission, such information or exhibit is
specifically not incorporated by reference in this prospectus supplement.
These documents may also be accessed on our website at www.cadencepharm.com. Except as
otherwise specifically incorporated by reference in this prospectus, information contained in, or
accessible through, our website is not a part of this prospectus supplement. You may also request a
copy of any or all of the information incorporated by reference, at no cost, by writing or
telephoning us at the following address:
Cadence Pharmaceuticals, Inc.
12481 High Bluff Drive, Suite 200
San Diego, California 92130
(858) 436-1400
You should rely only on the information we have provided or incorporated by reference in this
prospectus supplement or in the accompanying prospectus.
S-34
PROSPECTUS
$100,000,000
CADENCE PHARMACEUTICALS, INC.
Common Stock
Our common stock is traded on the Nasdaq Global Market under the symbol CADX. On November
29, 2007, the last reported sale price of our common stock on the Nasdaq Global Market was $13.76
per share.
This prospectus and the accompanying prospectus supplement will allow us to sell shares of our
common stock from time to time in one or more offerings, with an aggregate offering price of up to
$100,000,000. Each time we sell shares of our common stock, we will provide you with a supplement
to this prospectus. The prospectus supplement may add, update or change information contained in
this prospectus or in documents we have incorporated by reference to this prospectus. You should
read both this prospectus and the applicable prospectus supplement, including all documents
incorporated herein or therein by reference, carefully before you invest in our common stock.
When we offer our common stock, we will provide specific terms of the offering in supplements
to this prospectus. The common stock offered by this prospectus and any prospectus supplement may
be offered directly or to or through underwriters or dealers. If any underwriters are involved in
the sale of any common stock offered by this prospectus and any prospectus supplement, their names,
and any applicable purchase price, fee, commission or discount arrangement between or among them,
will be set forth, or will be calculable from the information set forth, in the applicable
prospectus supplement.
This prospectus may not be used to offer or sell any securities unless accompanied by the
applicable prospectus supplement.
Investing in our securities involves risks. See Risk Factors beginning on page 2.
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 December 11, 2007.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS |
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ABOUT CADENCE PHARMACEUTICALS, INC. |
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RISK FACTORS |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
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USE OF PROCEEDS |
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PLAN OF DISTRIBUTION |
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DESCRIPTION OF COMMON STOCK |
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CERTAIN PROVISIONS OF DELAWARE LAW AND OF THE COMPANYS CERTIFICATE OF INCORPORATION AND BYLAWS |
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LEGAL MATTERS |
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EXPERTS |
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LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES |
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WHERE YOU CAN FIND MORE INFORMATION |
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE |
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ABOUT THIS PROSPECTUS
This prospectus is a part of a registration statement that we filed with the Securities and
Exchange Commission, or the Commission, utilizing a shelf registration process. Under this shelf
registration process, we may sell shares of our common stock in one or more offerings up to a total
dollar amount of $100,000,000. This prospectus provides you with a general description of the
common stock we may offer. Each time we sell any of our common stock under this shelf registration,
we will provide a prospectus supplement that will contain specific information about the terms of
that offering. The prospectus supplement may also add, update or change information contained in
this prospectus or in documents we have incorporated by reference to this prospectus. To the extent
that any statement that we make in a prospectus supplement is inconsistent with statements made in
this prospectus or in documents we have incorporated by reference, the statements made in this
prospectus will be deemed modified or superseded by those made in the prospectus supplement. You
should read both this prospectus and any prospectus supplement, including all documents
incorporated herein or therein by reference, together with additional information described under
Where You Can Find More Information.
We have not authorized any dealer, salesman or other person to give any information or to make
any representation other than those contained or incorporated by reference in this prospectus and
the accompanying prospectus supplement. You must not rely upon any information or representation
not contained or incorporated by reference in this prospectus or the accompanying prospectus
supplement. This prospectus and the accompanying prospectus supplement do not constitute an offer
to sell or the solicitation of an offer to buy any securities other than the common stock
registered, nor do this prospectus and the accompanying prospectus supplement constitute an offer
to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom
it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that
the information contained in this prospectus and the accompanying prospectus supplement is accurate
on any date subsequent to the date set forth on the front of the document or that any information
we have incorporated by reference is correct on any date subsequent to the date of the document
incorporated by reference, even though this prospectus and any accompanying prospectus supplement
is delivered or securities are sold on a later date.
The U.S. Patent and Trademark Office has issued a Notice of Allowance in connection with our
intent-to-use trademark application for the mark CADENCE, covering pharmaceutical preparations for
the treatment or prevention of diseases or infections of the bodys major organs, including the
heart, lungs, liver and kidneys; pharmaceutical preparations for the treatment or prevention of
diseases of the bodys systems, including the immune system and the cardiovascular system; and
pharmaceutical preparations to treat or manage pain, anesthesia, surgical and medical procedures. A
Notice of Allowance is a notice issued by the U.S. Patent and Trademark Office to an
intent-to-use application once all steps of the application process have been completed. Once
the Notice of Allowance has been issued, the applicant has six months to file a statement of use or
an extension, showing that it is
1
using the mark in commerce, in order for the U.S. Patent and
Trademark Office to issue a certificate of registration. We are developing commercial names for our
product candidates, and have applied for U.S. trademark registration for Omigard and
Acetavance. This prospectus also contains the trademark, Perfalgan®, which is a registered
trademark of Bristol-Myers Squibb Company.
ABOUT CADENCE PHARMACUTICALS, INC.
We are a biopharmaceutical company focused on in-licensing, developing and commercializing
proprietary product candidates principally for use in the hospital setting. Since our inception in
May 2004, we have in-licensed rights to two product candidates, both of which are currently being
studied in Phase III clinical trials. We have in-licensed the exclusive U.S. and Canadian rights to
Acetavance, formerly known as IV APAP, an intravenous formulation of acetaminophen that is
currently marketed in Europe by Bristol-Myers Squibb Company, or BMS, and several other markets for
the treatment of acute pain and fever under the brand name Perfalgan®. We have also in-licensed the
exclusive North American and European rights to omiganan pentahydrochloride 1% aqueous gel, or
Omigard, for the prevention and treatment of device-related, surgical wound-related and
burn-related infections. We believe that the hospital setting is a concentrated, underserved market
for pharmaceuticals and anticipate building our own, hospital-focused sales force as our product
candidates approach potential U.S. Food and Drug Administration, or FDA, approval. We intend to
build a leading franchise in the hospital setting, continuing to focus on products that are in late
stages of development, currently commercialized outside the U.S., or approved in the U.S. but with
significant commercial potential for proprietary new uses or formulations.
We were incorporated under the laws of the State of Delaware in May 2004. Our principal
executive offices are located at 12481 High Bluff Drive, Suite 200, San Diego, California 92130 and
our telephone number at that location is (858) 436-1400. Prior to November 2004, we were named
Strata Pharmaceuticals, Inc. Information about the company is also available at our website at
www.cadencepharm.com, which includes links to reports we have filed with the Commission. The
information on, or accessible through, our website is not part of this prospectus. Unless the
context requires otherwise, references in this prospectus to Cadence, we, us and our refer
to Cadence Pharmaceuticals, Inc.
RISK FACTORS
You should carefully consider the specific risks set forth under Risk Factors in the
applicable prospectus supplement, under Risk Factors in our most recent annual report on Form
10-K, and under Risk Factors in our most recent quarterly reports on Form 10-Q before making an
investment decision.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the information we incorporate by reference, contains
forward-looking statements that involve substantial risks and uncertainties. All statements, other
than statements of historical fact, included in this prospectus regarding our strategy, future
operations, future financial position, future revenue, projected costs, prospects, plans and
objectives of management are forward-looking statements. The words anticipate, believe,
estimate, expect, hope, intend, may, plan, project, will, would and similar
expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements and you should not place undue reliance on
our forward-looking statements. Actual results may differ materially from those set forth in this
prospectus or any prospectus supplement, including the information we incorporate by reference, due
to the risks and uncertainties inherent in our business, including, without limitation, the
following risks: we are largely dependent on the success of our only two product candidates,
Acetavance and Omigard, and we cannot be certain that our clinical development programs will be
sufficient to support new drug applications, or NDAs, or that either product candidate will receive
regulatory approval or be successfully commercialized; delays in the commencement, enrollment or
completion of clinical testing for either of our product candidates, or significant issues
regarding the adequacy of our clinical trial designs or the execution of our clinical trials, could
result in increased costs to us and delay or limit our ability to obtain regulatory approval; even
if our
product candidates are approved by regulatory authorities and commercialized, we expect
intense competition in the hospital marketplace for our targeted indications; unexpected adverse
side effects or inadequate therapeutic efficacy of Acetavance or Omigard that could delay or
prevent regulatory approval or commercialization, or that could result
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in recalls or product
liability claims; delays or quality issues with respect to the completion of required
pre-commercialization manufacturing development activities for our product candidates, could result
in increased costs to us and delay or limit our clinical trials and our ability to obtain
regulatory approval; the patent rights that we have in-licensed covering Acetavance are limited to
a specific intravenous formulation of acetaminophen, and our market opportunity for this product
candidate may be limited by the lack of patent protection for the active ingredient itself and
other formulations that may be developed by competitors; we will require 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 development programs and commercialization efforts; and our ability to
maintain patent protection for our products and to commercialize our products without infringing
the patent rights of others. Such statements include, but are not limited to, statements preceded
by, followed by or that otherwise include the words believes, expects, anticipates,
intends, estimates, projects, can, could, may, will, would or similar expressions.
For those statements, we claim the protection of the safe harbor for forward-looking statements
contained in Section 21E of the Private Securities Litigation Reform Act of 1995. You should not
rely unduly on these forward-looking statements, which speak only as of the date on which they were
made. We undertake no obligation to update publicly or revise any forward-looking statements,
whether as a result of new information, future events or otherwise, unless required by law.
USE OF PROCEEDS
Unless otherwise provided in the applicable prospectus supplement, we intend to use the net
proceeds from the sale of our common stock under this prospectus to fund clinical and preclinical
development of our product candidates and for general corporate purposes, including capital
expenditures and working capital. Due to the risks inherent in the development process and given
the stage of development of our programs, we are unable to estimate with any certainty the total
costs or when we will incur these costs in the continued development of our product candidates for
potential commercialization. We may also use a portion of the net proceeds to acquire or invest in
complementary businesses or products or to obtain rights to such complementary technologies. We
have no commitments with respect to any such acquisitions or investments. The amounts and timing of
our actual expenditures will depend on numerous factors, including the progress in, and costs of,
our preclinical and clinical drug programs and the amount and timing of revenues, if any, from our
current or future collaborations. We therefore cannot estimate the amount of net proceeds to be
used for all of the purposes described above. We may find it necessary or advisable to use the net
proceeds for other purposes, and we will have broad discretion in the application of the net
proceeds. We will set forth in the prospectus supplement our intended use for the net proceeds
received from the sale of our common stock. Pending the uses described above, we intend to invest
the net proceeds in interest-bearing, investment-grade securities.
PLAN OF DISTRIBUTION
We may sell our common stock covered by this prospectus from time to time pursuant to
underwritten public offerings, negotiated transactions, block trades or a combination of these
methods. We may sell the common stock separately or together:
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through one or more underwriters or dealers in a public offering and sale by them; |
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through agents; and/or |
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directly to one or more purchasers. |
We may distribute the common stock from time to time in one or more transactions:
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at a fixed price or prices, which may be changed; |
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at market prices prevailing at the time of sale; |
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at prices related to such prevailing market prices; or |
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at negotiated prices. |
We may solicit directly offers to purchase the common stock being offered by this prospectus.
We may also designate agents to solicit offers to purchase the common stock from time to time. We
will name in a prospectus supplement any agent involved in the offer or sale of our securities.
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If we utilize a dealer in the sale of the common stock being offered by this prospectus, we
will sell the common stock to the dealer, as principal. The dealer may then resell the common stock
to the public at varying prices to be determined by the dealer at the time of resale.
If we utilize an underwriter in the sale of the common stock being offered by this prospectus,
we will execute an underwriting agreement with the underwriter at the time of sale and we will
provide the name of any underwriter in the prospectus supplement that the underwriter will use to
make resales of the common stock to the public. In connection with the sale of the common stock, we
or the purchasers of the common stock for whom the underwriter may act as agent, may compensate the
underwriter in the form of underwriting discounts or commissions. The underwriter may sell the
common stock to or through dealers, and the underwriter may compensate those dealers in the form of
discounts, concessions or commissions.
We will provide in the applicable prospectus supplement any compensation we will pay to
underwriters, dealers or agents in connection with the offering of the securities, and any
discounts, concessions or commissions allowed by underwriters to participating dealers.
Underwriters, dealers and agents participating in the distribution of the securities may be deemed
to be underwriters within the meaning of the Securities Act of 1933, as amended, or the Securities
Act, and any discounts and commissions received by them and any profit realized by them on resale
of the common stock may be deemed to be underwriting discounts and commissions. We may enter into
agreements to indemnify underwriters, dealers and agents against civil liabilities, including
liabilities under the Securities Act, or to contribute to payments they may be required to make in
respect thereof.
To facilitate the offering of our common stock, certain persons participating in the offering
may engage in transactions that stabilize, maintain or otherwise affect the price of the
securities. This may include over-allotments or short sales of the common stock, which involves the
sale by persons participating in the offering of more common stock than we sold to them. In these
circumstances, these persons would cover such over-allotments or short positions by making
purchases in the open market or by exercising their over-allotment option. In addition, these
persons may stabilize or maintain the price of the common stock by bidding for or purchasing
securities in the open market or by imposing penalty bids, whereby selling concessions allowed to
dealers participating in the offering may be reclaimed if securities sold by them are repurchased
in connection with stabilization transactions. The effect of these transactions may be to stabilize
or maintain the market price of the common stock at a level above that which might otherwise
prevail in the open market. These transactions may be discontinued at any time.
The underwriters, dealers and agents may engage in transactions with us, or perform services
for us, in the ordinary course of business.
DESCRIPTION OF COMMON STOCK
The following summary of the terms of our common stock does not purport to be complete and is
subject to and qualified in its entirety by reference to our Amended and Restated Certificate of
Incorporation, or certificate of incorporation, and Amended and Restated Bylaws, or bylaws, copies
of which are on file with the Commission as exhibits to registration statements previously filed by
us. See Where You Can Find More Information.
General
We have authority to issue 100,000,000 shares of common stock, $0.0001 par value per share. As
of November 30, 2007, we had 29,111,208 shares of common stock outstanding. As of November 30,
2007, we had an aggregate of 2,449,789 shares of common stock reserved for issuance upon exercise
of outstanding stock options granted under our 2004 Equity Incentive Award Plan and 2006 Equity
Incentive Award Plan and an aggregate of 1,409,104 shares of common stock reserved for future
issuance under our 2006 Equity Incentive Award Plan.
Voting Rights
The holders of our common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of the stockholders, including the election of directors, and do not
have cumulative voting rights.
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Accordingly, the holders of a majority of the shares of common stock
entitled to vote in any election of directors can elect all of the directors standing for election,
if they so choose.
Dividends
Subject to preferences that may be applicable to any then outstanding preferred stock, holders
of common stock are entitled to receive ratably those dividends, if any, as may be declared by the
board of directors out of legally available funds.
Liquidation
Upon our liquidation, dissolution or winding up, the holders of common stock will be entitled
to share ratably in the net assets legally available for distribution to stockholders after the
payment of all of our debts and other liabilities of our company, subject to the prior rights of
any preferred stock then outstanding.
Rights and Preferences
Holders of common stock have no preemptive or conversion rights or other subscription rights
and there are no redemption or sinking funds provisions applicable to the common stock.
Fully Paid and Nonassessable
All outstanding shares of our common stock are fully paid and nonassessable and the shares of
common stock offered hereby will be fully paid and nonassessable.
Registration Rights
The holders of approximately 17,436,241 shares of common stock are entitled to rights with
respect to the registration of these shares under the Securities Act. These shares are referred to
as registrable securities. Under the terms of the agreement between us and the holders of the
registrable securities, if we propose to register any of our securities under the Securities Act,
these holders are entitled to notice of such registration and are entitled to include their shares
of registrable securities in our registration. Certain of these holders are entitled to demand
registration, pursuant to which they may require us to use our best efforts to register their
registrable securities under the Securities Act at our expense, up to a maximum of two
registrations. Holders of registrable securities may also require us to file an unlimited number of
additional registration statements on Form S-3 at our expense so long as the holders propose to
sell registrable securities of at least $1.0 million and we have not already filed two registration
statements on Form S-3 in the previous twelve months.
All of these registration rights are subject to certain conditions and limitations, among them
the right of the underwriters of an offering to limit the number of shares included in such
registration and our right not to effect a requested registration 60 days prior to or 180 days
after an offering of our securities, including the offering made here.
Certificate of Incorporation and Bylaw Provisions
See Certain Provisions of Delaware Law and of the Companys Certificate of Incorporation and
Bylaws Anti-Takeover Effects of Provisions of Our Amended and Restated Certificate of
Incorporation, Our Amended and Restated Bylaws and Delaware Law for a description of provisions of
our certificate of incorporation and bylaws which may have the effect of delaying changes in our
control or management.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American Stock Transfer & Trust
Company.
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CERTAIN PROVISIONS OF DELAWARE LAW AND OF THE
COMPANYS CERTIFICATE OF INCORPORATION AND BYLAWS
Anti-Takeover Effects of Provisions of Our Amended and Restated Certificate of Incorporation, Our
Amended and Restated Bylaws and Delaware Law
Some provisions of Delaware law, our amended and restated certificate of incorporation and our
bylaws contain provisions that could make the following transactions more difficult: acquisition of
us by means of a tender offer; acquisition of us by means of a proxy contest or otherwise; or
removal of our incumbent officers and directors. It is possible that these provisions could make it
more difficult to accomplish or could deter transactions that stockholders may otherwise consider
to be in their best interests or in our best interests, including transactions that might result in
a premium over the market price for our shares.
These provisions, summarized below, are expected to discourage coercive takeover practices and
inadequate takeover bids. These provisions are also designed to encourage persons seeking to
acquire control of us to first negotiate with our board of directors. We believe that the benefits
of increased protection of our potential ability to negotiate with the proponent of an unfriendly
or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging
these proposals because negotiation of these proposals could result in an improvement of their
terms.
Undesignated Preferred Stock
The ability to authorize undesignated preferred stock makes it possible for our board of
directors to issue preferred stock with voting or other rights or preferences that could impede the
success of any attempt to change control of us. These and other provisions may have the effect of
deferring hostile takeovers or delaying changes in control or management of our company.
Stockholder Meetings
Our charter documents provide that a special meeting of stockholders may be called only by our
chairman of the board, chief executive officer or president, or by a resolution adopted by a
majority of our board of directors.
Requirements for Advance Notification of Stockholder Nominations and Proposals
Our bylaws establish advance notice procedures with respect to stockholder proposals and the
nomination of candidates for election as directors, other than nominations made by or at the
direction of the board of directors or a committee of the board of directors.
Elimination of Stockholder Action by Written Consent
Our certificate of incorporation eliminates the right of stockholders to act by written
consent without a meeting.
Election and Removal of Directors
Our board of directors is divided into three classes. The directors in each class will serve
for a three-year term, one class being elected each year by our stockholders. This system of
electing and removing directors may tend to discourage a third party from making a tender offer or
otherwise attempting to obtain control of us, because it generally makes it more difficult for
stockholders to replace a majority of the directors.
Delaware Anti-Takeover Statute
We are subject to Section 203 of the Delaware General Corporation Law which prohibits persons
deemed interested stockholders from engaging in a business combination with a publicly-held
Delaware corporation for three years following the date these persons become interested
stockholders unless the business combination is, or the transaction in which the person became an
interested stockholder was, approved in a prescribed manner or
another prescribed exception applies. Generally, an interested stockholder is a person who,
together with affiliates
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and associates, owns, or within three years prior to the determination of
interested stockholder status did own, 15% or more of a corporations voting stock. Generally, a
business combination includes a merger, asset or stock sale, or other transaction resulting in a
financial benefit to the interested stockholder. The existence of this provision may have an
anti-takeover effect with respect to transactions not approved in advance by the board of
directors.
Amendment of Charter Provisions
The amendment of any of the above provisions, except for the provision making it possible for
our board of directors to issue preferred stock, would require approval by holders of at least 66
2/3% of our then outstanding common stock.
The provisions of Delaware law, our certificate of incorporation and our bylaws could have the
effect of discouraging others from attempting hostile takeovers and, as a consequence, they may
also inhibit temporary fluctuations in the market price of our common stock that often result from
actual or rumored hostile takeover attempts. These provisions may also have the effect of
preventing changes in our management. It is possible that these provisions could make it more
difficult to accomplish transactions that stockholders may otherwise deem to be in their best
interests.
LEGAL MATTERS
The validity of the issuance of the shares of our common stock described herein will be passed
upon by Latham & Watkins LLP, San Diego, California.
EXPERTS
The financial statements incorporated in this Prospectus by reference to the Annual Report on
Form 10-K for the year ended December 31, 2006 have been audited by Ernst & Young LLP, independent
registered public accounting firm, as set forth in their report thereon and incorporated herein by
reference. Such financial statements are incorporated herein by reference in reliance upon such
report given on the authority of such firm as experts in accounting and auditing.
LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Our certificate of incorporation and bylaws provide that we will indemnify our directors and
officers, and may indemnify our employees and other agents, to the fullest extent permitted by the
Delaware General Corporation Law. Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that, in the opinion of the Commission,
such indemnification is against public policy as expressed in the Securities Act and is therefore
unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information with the
Commission. You may read and copy any document we file at the Commissions Public Reference Room
located at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330
for further information on the Public Reference Room. The Commission maintains an Internet site at
www.sec.gov that contains reports, proxy and information statements and other information regarding
issuers that file electronically with the Commission.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The Commission allows us to incorporate by reference the information we file with them which
means that we can disclose important information to you by referring you to those documents instead
of having to repeat the information in this prospectus. The information incorporated by reference
is considered to be part of this prospectus,
and later information that we file with the Commission
will automatically update and supersede
this information. We incorporate by reference the documents listed below and any future filings we
will make with the Commission
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under Sections 13(a), 13(c), 14, or 15(d) of the Securities Exchange
Act of 1934, as amended, or the Exchange Act, between the date of this prospectus and the
termination of the offering and also between the date of the initial registration statement and
prior to effectiveness of the registration statement:
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our annual report on Form 10-K for the year ended December 31, 2006, filed on March
28, 2007; |
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our quarterly reports on Form 10-Q for the quarterly periods ended March 31, 2007
(filed on May 15, 2007), June 30, 2007 (filed on August 14, 2007) and September 30, 2007
(filed on November 14, 2007); |
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our current reports on Form 8-K filed on January 30, 2007, March 28, 2007, April 20,
2007 and July 23, 2007; |
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our definitive proxy statement on Schedule 14A filed on April 30, 2007; |
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the description of our common stock contained in our registration statement on Form
8-A (File No. 001-33103), filed on October 19, 2006; and |
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all documents filed by us with the Commission under Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act after the date of this prospectus and before termination of
this offering. |
To the extent that any information contained in any current report on Form 8-K or any exhibit
thereto, was furnished, rather than filed with the Commission, such information or exhibit is
specifically not incorporated by reference in this prospectus.
This prospectus is part of a registration statement on Form S-3 we have filed with the
Commission under the Securities Act. The rules and regulations of the Commission allow us to omit
from this prospectus certain information included in the registration statement. For further
information about us and our securities, you should refer to the registration statement and the
exhibits and schedules filed with the registration statement. With respect to the statements
contained in this prospectus regarding the contents of any agreement or any other document, in each
instance, the statement is qualified in all respects by the complete text of the agreement or
document, a copy of which has been filed as an exhibit to the registration statement.
These documents may also be accessed on our website at www.cadencepharm.com. Except as
otherwise specifically incorporated by reference in this prospectus, information contained in, or
accessible through, our website is not a part of this prospectus.
You may request a copy of any or all of the information incorporated by reference, at no cost,
by writing or telephoning us at the following address:
Cadence Pharmaceuticals, Inc.
12481 High Bluff Drive, Suite 200
San Diego, California 92130
(858) 436-1400
8
9,240,307 Shares
Common Stock
PROSPECTUS SUPPLEMENT
February 14, 2008