e424b5
Filed Pursuant to Rule 424(b)(5)
Registration Statement No. (333-121612)
Registration Statement No. (333-142628)
Prospectus Supplement
(to prospectus dated January 24, 2005)
UP
TO 5,134,100 SHARES
SPECTRUM PHARMACEUTICALS, INC.
COMMON
STOCK
This
prospectus supplement relates to an offering by us of up to 5,134,100 shares of our
common stock. Our common stock is quoted on the Nasdaq Global Market under the symbol SPPI. The
last reported sale price of our common stock on the Nasdaq Global Market on May 3, 2007 was $6.52
per share.
Investing in our common stock involves risks. See Risk Factors beginning on page S-7 of
this prospectus supplement.
Oppenheimer & Co. Inc., Lazard Capital Markets LLC, Rodman & Renshaw, LLC and ThinkEquity
Partners, LLC have agreed to act as the placement agents (the Placement Agents) in connection with
this offering, with Oppenheimer & Co. Inc. acting as lead placement agent, and Lazard Capital
Markets LLC acting as co-lead placement agent. We have agreed to pay the Placement Agents fees as
set forth below.
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Per Share |
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Total |
Public Offering Price |
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$ |
6.25 |
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$ |
32,088,125 |
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Placement Agents Fees |
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$ |
.375 |
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$ |
1,925,288 |
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Proceeds to Us, Before Expenses |
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$ |
5.875 |
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$ |
30,162,838 |
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We estimate that the total expenses for this offering, excluding the Placement Agents fees,
will be approximately $75,000. Because there is no minimum offering amount required as a condition
to the closing of this offering, the actual public offering amount, Placement Agents fees and net
proceeds to us, if any, in this offering are not presently determinable and may be substantially
less than the maximum offering amount set forth above. We expect that delivery of the shares of
common stock being offered pursuant to this prospectus supplement will be made to purchasers on or
about May 9, 2007. Certain purchasers funds will be deposited into an escrow account and held
until jointly released by us and the Placement Agents on the date that the shares are delivered to
the purchasers. All funds received will be held in a non-interest bearing account.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus supplement or the
accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal
offense.
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Oppenheimer
& Co.
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Lazard
Capital Markets |
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Rodman & Renshaw, LLC
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ThinkEquity Partners, LLC |
The date of this prospectus supplement is May 4, 2007.
TABLE OF CONTENTS
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S-1 |
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S-3 |
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S-5 |
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S-6 |
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S-7 |
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S-7 |
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S-14 |
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S-19 |
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S-20 |
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S-20 |
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S-21 |
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S-24 |
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S-25 |
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S-25 |
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S-25 |
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S-25 |
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You should rely only on the information in this prospectus supplement, the accompanying
prospectus and the documents incorporated by reference. Neither we nor the placement agents have
authorized anyone to provide you with different information. The information in these documents is
accurate only as of its respective date, regardless of the time of delivery of any document or of
any sale of our common stock. Our business, financial condition, results of operations and
prospects may have changed since the dates of such documents. We are making offers to sell and
seeking offers to buy shares of our common stock only in jurisdictions where offers and sales are
permitted. You should not consider this prospectus supplement and the accompanying prospectus to
be an offer to sell, or a solicitation of an offer to buy, shares of our common stock if the person
making the offer or solicitation is not qualified to do so or if it is unlawful for you to receive
the offer or solicitation.
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement and the accompanying prospectus are part of a shelf registration
statement on Form S-3, registration statement number 333-121612, that we filed with the Securities
and Exchange Commission (the SEC) on January 24, 2005, as augmented by the Form S-3 filed by the
Company on May 4, 2007. This prospectus supplement describes the specific details regarding this
offering, including the price, the amount of our common stock being offered, the risks of investing
in our common stock and other items. The accompanying prospectus provides more general
information. To the extent that information in this prospectus supplement or any of the documents
incorporated by reference into this prospectus supplement is inconsistent with the accompanying
prospectus or any of the documents incorporated by reference into the accompanying prospectus, you
should rely on this prospectus supplement or the documents incorporated by reference into this
prospectus supplement, as the case may be. You should read both this prospectus supplement and the
accompanying prospectus together with the additional information about us described in the section
entitled Where You Can Find More Information.
References in this prospectus supplement, the accompanying prospectus and the documents
incorporated by reference to we, our, us, Spectrum and the Company refer to Spectrum
Pharmaceuticals, Inc. and its subsidiaries, unless the context requires otherwise.
FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying prospectus, together with the documents
incorporated by reference therein, contain certain forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of
the Securities Exchange Act of 1934, as amended (the Exchange Act), in reliance upon the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements regarding our future product development activities and costs, the
revenue potential (licensing, royalties and sales) of our product candidates, the safety and
efficacy of our drug products, the timing and likelihood of achieving development milestones and
product revenues, the sufficiency of our capital resources, and other statements containing
forward-looking words, such as, believes, may, could, will, expects, intends,
estimates, anticipates, plans, seeks, or continues. Such forward-looking statements are
based on the beliefs of the Companys management as well as assumptions made by and information
currently available to the Companys management. Readers should not put undue reliance on these
forward-looking statements. Forward-looking statements are inherently subject to risks and
uncertainties, some of which cannot be predicted or quantified; therefore, our actual results may
differ materially from those described in any forward-looking statements. Factors that might cause
such a difference include, but are not limited to, those discussed below, including under Risk
Factors as well as those discussed in our periodic reports filed with the Securities and Exchange
Commission including our Annual Report on Form 10-K for the year ended December 31, 2006 and
Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. These factors include, but are
not limited to:
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our ability to successfully develop, obtain regulatory approvals for and market our products; |
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our ability to generate and maintain sufficient cash resources to fund our business; |
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our ability to enter into strategic alliances with partners for manufacturing,
development and commercialization; |
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our ability to identify new product candidates; |
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the timing or results of pending or future clinical trials; |
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competition in the marketplace for our generic drugs; |
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actions by the Food and Drug Administration and other regulatory agencies; |
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demand and market acceptance for our approved products; and |
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the effect of changing economic conditions. |
We do not plan to update any such forward-looking statements and expressly disclaim any duty
to update the information contained in this prospectus supplement except as required by law.
For a discussion of some of the factors that may cause actual results to differ materially
from those suggested by the forward-looking statements, please read carefully the information under
Risk Factors beginning on page S-8 of this prospectus supplement. The list of factors discussed
under Risk Factors that may affect future performance and the accuracy of forward-looking
statements is illustrative, but by no means exhaustive. Accordingly, all forward-looking
statements should be evaluated with the understanding of their inherent uncertainty.
INDUSTRY AND MARKET DATA
Industry data and other statistical information used in this prospectus supplement are based
on independent publications, government publications, reports by market research firms or other
published independent sources. Some data is also based on our good faith estimates, derived from
our review of internal surveys and the independent sources listed above. Although we believe these
sources are reliable, we have not independently verified such information.
SUMMARY
This summary highlights information contained elsewhere in this prospectus supplement, the
accompanying prospectus and the documents incorporated by reference. This summary does not contain
all of the information that you should consider before deciding to invest in our common stock. You
should read this entire prospectus supplement, the accompanying prospectus and the documents
incorporated by reference carefully, including the Risk
Factors section beginning on page S-7 of
this prospectus supplement and our consolidated financial statements and the related notes and the
other documents incorporated by reference.
Our Company
We are a biopharmaceutical company that acquires and advances a diversified portfolio of drug
candidates, with a focus on oncology, urology and other critical health challenges for which there
are few other treatment options. Our expertise lies in identifying undervalued drugs with
demonstrated safety and efficacy, and adding value through further clinical development and
selection of the most viable and risk-reduced methods of commercialization. We currently have ten
drugs in development, including five in late stage clinical development.
The pillars of our risk-reduced business model are: 1) reduce scientific and clinical risk
as much as is commercially viable by developing a broad and diverse pipeline with a late stage
focus with emphasis on known mechanisms of action; 2) utilize organizational, collaborative,
scientific and commercial efficiencies from a therapeutic focus on oncology and urology; 3) finance
the development of our proprietary pipeline with multiple sources of financing, not just equity;
and 4) build and maintain a team with significant drug development experience, in other words, a
team that has done it before. Our strategy allows us the opportunity to build a diversified
portfolio of drugs, strengthen our development and commercialization capabilities, while sharing
risk through business alliances and leveraging near-term revenue opportunities. Our commitment is
to build a successful commercial biopharmaceutical company with sustainable future growth from
revenue-generating prescription drugs in oncology and urology.
Since August 2002, we have accomplished a successful turnaround by shifting our strategic
focus from drug discovery, neurology drugs and genomics research, to development of a diversified
drug portfolio containing primarily clinical stage oncology, or anti-cancer, drugs. During this
period, we have enhanced our financial strength and capabilities by securing over $100 million in
equity financing and upfront license fees, and entering into several strategic business alliances.
These actions enabled us to acquire development rights to several new proprietary drug product
candidates, strengthen our management team, enhance our developmental and regulatory capabilities,
and accelerate the development timelines of our key drug product candidates.
S-1
Business Strategy
Our mission is to bring our expertise and passion for excellence to acquire, develop and
commercialize pharmaceuticals for unmet medical needs while building value for our shareholders.
Our business model is unique in that it is tightly focused to reduce risk and improve our odds of
success. The tenets of our business strategy to fulfill this mission are:
Reduce Scientific and Clinical Risk:
We take a portfolio approach to managing our pipeline that balances the size of the market
opportunities with clear and defined clinical and regulatory paths to approval. We acquire and
develop multiple novel, late-stage oncology product candidates that address niche markets. Each of
these work differently and are based on diverse technologies. Just like the physicians and
patients that we serve, we are not constrained by any one technology. A late stage focus helps us
effectively manage the high cost of drug development by focusing on compounds that have already
passed the many costly hurdles in the pre-clinical and clinical process.
Executing on our portfolio strategy, we currently have ten drugs in development, including
five in late stage clinical development. We expect to have two drugs approved by the FDA and to
begin two registrational Phase 3 clinical trials in 2007 or shortly
thereafter. Additionally, we expect to launch an
additional drug in 2008. Finally, while we continue to advance our existing product portfolio, we
are evaluating additional promising proprietary drugs for acquisition or in-licensing from third
parties.
Realize efficiencies from therapeutic focus:
Our model allows us to leverage organizational, collaborative, commercial and scientific
efficiencies from a therapeutic focus on oncology, and a near-term commercialization focus on
urology. Our model lets us pursue promising technologies without tying up our resources on
unpromising candidates.
If we participate in the U.S. co-promotion of satraplatin, our lead drug, in prostate cancer,
it will serve as a platform to introduce EOquin® for non-invasive bladder cancer and Ozarelix for
benign prostate hypertrophy, or BPH, because all of these diseases are treated by urologists.
Finally, our therapeutic concentration allows us to focus our business development efforts to
better cover the depth and breadth of the scientific and commercial communities in our relevant
areas of focus to find appropriate drug candidates for acquisition or in-license.
Strategic Alliances:
To mitigate risks inherent in the drug development process, to accelerate drug development
timelines, and to opportunistically generate cash, we will seek to out-license rights to certain of
our intellectual property and proprietary products for the development and commercialization of
those products, particularly outside the United States, in exchange for upfront fees, milestone
payments, royalties and other commercialization privileges.
S-2
Near-term Revenues:
Recognizing that new drug development is a lengthy process, we focus primarily on late stage
proprietary compounds with the potential for generating revenues in the near-term. Our current
near-term revenue drivers are satraplatin, expected to be launched in 2007, or soon thereafter, if
approved by the FDA; and Levofolinic Acid, or LFA, and sumatriptan injection, the generic form of
Imitrex® injection. In addition, as EOquin® and Ozarelix are poised to commence Phase 3 trials in
2007, we may, at the appropriate time, seek partners to provide us with upfront licensing fees,
milestone payments and royalties on sales for ex-North American rights to the development and
commercialization of EOquin®.
Product Commercialization:
As our drugs progress through development, to the point of potential FDA approval for
marketing in the United States, we plan to expand our sales and marketing capability. However, the
costs of establishing and maintaining a sales force to effectively market proprietary drug products
in the United States are significant. Accordingly, to accelerate the market penetration of our
proprietary products, when approved by the FDA, we may seek collaborations with entities with
proven sales, marketing and distribution capabilities in the United States.
Experienced Team:
We have built the foundation of a team with significant experience in oncology drug
development. We endeavor to leverage the talents of our team and add people who have relevant
experience. Members of our team have been responsible for the development of drugs such as
adriamycin, cisplatin, carboplatin, paclitaxel, doxorubicin, Etoposide, Buspar, Nefazodone and
Stadol, among others. We also plan to bring commercialization experience to the Company as our
products obtain FDA approval.
DRUG PRODUCT CANDIDATES
New drug development, which is the process whereby drug product candidates are tested for the
purpose of filing a New Drug Application (NDA) (or similar filing in other countries) and
eventually obtaining marketing approval from the FDA or a marketing authorization from other
regulatory authorities outside of the United States, is an inherently uncertain, lengthy and
expensive process which requires several phases of clinical trials to demonstrate to the
satisfaction of the FDA in the United States, and regulatory authorities in other countries, that
the products are both safe and effective for their respective indications. Our strategy is
designed to address the significant risks of drug development by focusing our acquisition and
development efforts on clinical stage drug candidates (those in human trials). We do, however,
also undertake the acquisition and development of promising pre-clinical drug candidates when we
believe that the therapy is novel and/or when we believe the drug candidates have a higher
probability of regulatory approval than those of a typical compound at a similar stage of
development.
S-3
Our drug candidates, their target indications, and status of development are summarized in the
following table:
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Drug Candidate |
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Target Indication |
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Development Status |
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Satraplatin
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Hormone Refractory Prostate Cancer
In multiple trials in other
cancer types; in combination with
radiation therapy; and in
combination with other
chemotherapies
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NDA on file with FDA
Phase(s) 1-2 |
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Levofolinic Acid, or
LFA
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High dose methotrexate rescue in
Osteogenic Sarcoma
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NDA on file with FDA; Chemistry, Manufacturing and
Controls, or CMC, responses pending |
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Colorectal Cancer
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Planned regulatory filing |
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Sumatriptan injection
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Migraines (generic form of GSKs
Imitrex® injection)
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Abbreviated New Drug Application (ANDA) with
Paragraph IV filed, litigation settled, launch
expected in the second half of 2008 |
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EOquin®
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Non-invasive Bladder Cancer
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SPA negotiated with FDA; Phase
3 recently initiated |
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Ozarelix
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Benign Prostatic Hypertrophy
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Phase 2b initiated first quarter of 2007; Phase
3/Safety Study to initiate by late 2007 |
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Hormone dependent Prostate Cancer
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Phase 2 study completed in 2006; Phase 2b study in
progress in Europe |
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Endometriosis
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Phase 1 study in second half of 2007 |
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Elsamitrucin
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Various potential cancers
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Phase 1/2 |
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Lucanthone
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Radiation Sensitizer for
Gliobastoma Multiforme and other
Brain Tumors and Brain Metastases
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Phase 1 expected to initiate in second half of 2007 |
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SPI-1620
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Adjunct to Chemotherapy
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Pre-clinical |
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RenaZorb
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Hyperphosphatemia in End-stage
Renal Disease
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Pre-clinical |
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SPI-205
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Chemotherapy Induced Neuropathy
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Pre-clinical |
While other indications have not yet been identified, some of our drug candidates may prove to
be beneficial in additional disease indications as we continue to study and develop these drug
candidates. In addition, we have intellectual property rights to neurology compounds that we may
out-license to third parties for further development.
We believe our drug candidates have the potential to be effective therapeutic agents with some
advantages over existing therapies. Our goal is to develop and commercialize many of these drugs
in the United States and license the rights to local companies in Japan and Europe for use in those
countries (to the extent that we have rights in those territories).
S-4
OVERVIEW OF MAJOR INDICATIONS WE ARE TARGETING
Cancer
Cancer is the second leading cause of death in the United States, accounting for approximately
25% of all deaths. In its most recent annual report, the American Cancer Society reported that in
the under-85 age group, cancer is the leading cause of death. In the United States, approximately
1.4 million new cancer cases are expected to be diagnosed in 2007 and over 560,000 persons are
expected to die from the disease in 2007. Accordingly, there is significant demand for improved
and novel cancer treatments.
Cancer occurs when abnormal cells divide without control. These cells can invade nearby
tissues or spread through the bloodstream and lymphatic system to other parts of the body. Five to
ten percent of all cancers are believed to be due to inheriting a faulty gene. The remaining 90 to
95 percent are believed to be caused by damage to the genes during a persons lifetime. This
damage can be caused by internal agents, such as hormones or an altered immune system, or external
agents, such as viruses, exposure to chemicals or harmful ultraviolet sunrays. Sometimes ten or
more years may pass between exposure and cancer detection. Cancer is currently treated by surgery,
chemotherapy, radiation therapy, hormonal therapy and immunotherapy. Cancer is referred to as
refractory when it has not responded or is no longer responding to a treatment.
We believe that traditional chemotherapeutic agents are likely to remain the mainstay therapy
for cancer for the foreseeable future. However, we continue to seek additional novel drugs, drug
delivery methods and combination therapies that address cancer or cancer related indications with
significant unmet medical need. Accordingly, we are actively seeking novel and proprietary
oncology drug candidates that:
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have demonstrated initial safety and efficacy in clinical trials and/or we believe
have a higher probability of regulatory approval than a typical compound at a similar
stage of development; |
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target cancer indications with significant unmet medical need, where current
treatments either do not exist or are not effective; and |
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we believe we can acquire at a fair value based on our judgment of clinical and
commercial potential. |
Benign Prostatic Hypertrophy
BPH is a non-cancerous enlargement of the prostate leading to difficulty in passing urine,
reduced flow of urine, discomfort or pain while passing urine and increased frequency of urination.
Enlargement of the prostate is caused by testosterone. According to Urology Today, benign
prostatic hypertrophy affects more than 50% of men over age 50 and as many as 80% of men over the
age of 70. Treatment options for benign prostatic hypertrophy include surgery and medications to
reduce the amount of tissue and increase the flow of urine.
Corporate Information
Our executive offices are located at 157 Technology Drive, Irvine, California 92618. Our telephone
number is (949) 788-6700. Our website address is www.spectrumpharm.com. Information contained on
our web site does not constitute part of this prospectus.
S-5
THE OFFERING
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Common stock offered
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5,134,100 shares |
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Common stock outstanding after
this offering
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30,804,821 shares |
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NASDAQ Global Market symbol
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SPPI |
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Use of proceeds
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Based on the offering price of $6.25 per
share, we estimate that the net proceeds
from this offering, after deducting
placement fees and the estimated offering
expenses payable by us, will be approximately $30 million. We
intend to use the net proceeds of the
offering for general corporate purposes.
See Use of Proceeds in this prospectus
supplement for more information. |
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Risk factors
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Investing in our common stock involves a
number of risks, which are described under
Risk Factors beginning on page S-7 of
this prospectus supplement and those
incorporated by reference from Item 1A of
Part I of our Annual Report on Form 10-K
for the year ended December 31, 2006 and
Item 1A of Part II of our Quarterly Report
on Form 10-Q for the period ended March 31,
2007. |
S-6
RISK FACTORS
An investment in our common stock involves a high degree of risk. Our business, financial
condition, operating results and prospects can be impacted by a number of factors, any one of which
could cause our actual results to differ materially from recent results or from our anticipated
future results. As a result, the trading price of our common stock could decline, and you could
lose a part or all of your investment. You should carefully consider the risks described below
with all of the other information that is incorporated by reference into this prospectus
supplement. Failure to satisfactorily achieve any of our objectives or avoid any of the risks
below would likely have a material adverse effect on our business and results of operations.
Risks Related to Our Business
Our losses will continue to increase as we expand our development efforts, and our efforts may
never result in profitability.
Our cumulative losses since our inception in 1987 through December 31, 2006 were in excess of
$200 million. We lost approximately $23 million in 2006, $19 million in 2005, and $12 million in
2004. We expect to continue to incur significant additional losses as we implement our growth
strategy of developing marketable drug products for at least the next several years unless they are
offset, if at all, by licensing revenues under our out-license agreement with GPC Biotech or from
the out-license of any of our other proprietary products and any profits from the sale of generic
products. We may never achieve significant revenues from sales of products or become profitable.
Even if we eventually generate significant revenues from sales, we will likely continue to incur
losses over the next several years.
Our business does not generate the cash needed to finance our ongoing operations and therefore,
we will likely need to continue to raise additional capital.
Our current business operations do not generate sufficient operating cash to finance the
clinical development of our drug product candidates. We have historically relied primarily on
raising capital through the sale of our securities and out-licensing our drug candidates and
technology to meet our financial needs. While we anticipate meaningful revenues in 2007 from
milestone payments and royalties from our satraplatin license agreement with GPC Biotech, and in
2008 from distribution of authorized generic versions of certain sumatriptan injection products by
our partner Par Pharmaceutical Companies, Inc. (Par), we believe that we will likely need to
continue to raise funds through public or private financings in order to continue future drug
product development and acquisition, and to capitalize on growth opportunities.
We may not be able to raise additional capital on favorable terms, if at all. Accordingly, we
may be forced to significantly change our business plans and restructure our operations to conserve
cash, which would likely involve out-licensing or selling some or all of our intellectual,
technological and tangible property not presently contemplated and at terms that we believe would
not be favorable to us, and/or reducing the scope and nature of our currently planned drug
development activities. An inability to raise additional capital would also impact our ability to
expand operations.
Clinical trials may fail to demonstrate the safety and efficacy of our proprietary drug
candidates, which could prevent or significantly delay obtaining regulatory approval.
Prior to receiving approval to commercialize any of our proprietary drug candidates, we must
demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction
of the FDA and other regulatory authorities in the United States and other countries, that each of
the products is both safe and effective. For each product candidate, we will need to demonstrate
its efficacy and monitor its safety throughout the process. If such development is unsuccessful,
our business and reputation would be harmed and our stock price would be adversely affected.
S-7
All of our product candidates are prone to the risks of failure inherent in drug development.
The results of pre-clinical studies and early stage clinical trials of our product candidates do
not necessarily predict the results of later stage clinical trials. Later stage clinical trials
may fail to demonstrate that a product candidate is safe and effective despite having progressed
through initial clinical testing. Even if we believe the data collected from clinical trials of
our drug candidates are promising, such data may not be sufficient to support approval by the FDA
or any other United States or foreign regulatory approval. Pre-clinical and clinical data can be
interpreted in different ways.
Accordingly, FDA officials could interpret such data in different ways than we or our partners
do, which could delay, limit or prevent regulatory approval. The FDA, other regulatory
authorities, our institutional review boards, our contract research organizations, or we may
suspend or terminate our clinical trials for our drug candidates. Any failure or significant delay
in completing clinical trials for our product candidates, or in receiving regulatory approval for
the sale of any drugs resulting from our drug candidates, may severely harm our business and
reputation. Even if we receive FDA and other regulatory approvals, our product candidates may
later exhibit adverse effects that may limit or prevent their widespread use, may cause the FDA to
revoke, suspend or limit their approval, or may force us to withdraw products derived from those
candidates from the market.
Our proprietary drug candidates, their target indications, and status of development are
summarized in the table provided above under Prospectus Supplement Summary Drug Product
Candidates.
The development of our drug candidate, satraplatin, depends on the efforts of a third party and,
therefore, its eventual success or commercial viability is largely beyond our control.
In 2002, we entered into a co-development and license agreement with GPC Biotech for the
worldwide development and commercialization of our lead drug candidate, satraplatin. GPC Biotech
has agreed to fully fund development and commercialization expenses for satraplatin. We do not
have control over the drug development process and therefore the success of our lead drug candidate
depends upon the efforts of GPC Biotech and its sublicensee, Pharmion. GPC Biotech and its
sublicensee may not be successful in the clinical development of the drug, the achievement of any
additional milestones such as the acceptance of an NDA filing by the FDA, or the eventual
commercialization of satraplatin.
We may not be able to obtain co-promotion rights in the United States with regard to our drug
candidate, satraplatin, under our co-development and license agreement with GPC Biotech which
may adversely affect our ability to timely establish our own sales force in the United States,
if and when we choose to do so.
Pursuant to the terms of our co-development and license agreement with GPC Biotech, in the
event GPC Biotech determines to market satraplatin itself within the United States, we will have
the right to co-promote satraplatin in the United States with GPC Biotech pursuant to terms to be
negotiated by both parties. If GPC Biotech grants rights to a third party to market satraplatin in
the United States, then GPC Biotech is only obligated to use commercially reasonable efforts to
obtain co-promotion rights for us with such third party. Therefore, we may not be able to obtain
co-promotion rights for satraplatin in the United States, which may adversely affect our ability to
timely establish our own sales force in the United States, if and when we choose to do so.
An adverse outcome in the arbitration proceedings with GPC Biotech may hurt our financial and
strategic prospects.
We are currently in arbitration with GPC Biotech. The arbitration panel may rule against us
on our demand and/or may rule in favor of GPC Biotech on its counterclaim, which could cause us
significant financial and strategic harm, including if GPC Biotech does not have to negotiate in
good faith with us for a co-promotion agreement and/or GPC Biotech does not have to pay us
milestone payments and royalties. In addition, GPC Biotech has taken the position that the fact we
are currently in arbitration with them makes negotiation over a co-promotion agreement no longer
tenable, and that further negotiations would neither be appropriate nor productive.
S-8
The size of the market for our potential products is uncertain.
We often provide estimates of the number of people who suffer from the diseases that our drugs
are targeting. However, there is limited information available regarding the actual size of these
patient populations. In addition, it is uncertain whether the results from previous or future
clinical trials of drug candidates will be observed in broader patient populations, and the number
of patients who may benefit from our drug candidates may be significantly smaller than the
estimated patient populations.
Our drug candidate Levofolinic Acid, or LFA, may not be more effective, safer or more cost
efficient than competing drugs and otherwise may not have any competitive advantage, which could
hinder our ability to successfully commercialize LFA.
LFA is the pure active isomer of calcium leucovorin, a component of standard of care 5-FU
containing regimens for the treatment of colorectal cancer and other malignancies. Leucovorin has
been sold as a generic product on the market for a number of years. There are a number of generic
companies currently selling the product. Even if LFA ultimately receives FDA approval, it may not
have better efficacy in treating the target indication or a more favorable side-effect profile than
generic leucovorin. If we are not able to demonstrate a competitive advantage over generic
leucovorin, we may not be able to obtain a price premium over generic leucovorin. If we are not
able to obtain a price premium, we may not be able to manufacture LFA in a cost efficient manner or
at a cost below the generic leucovorin cost price. Also, LFA will be offered as part of a
treatment regimen, and that regimen may change to exclude LFA. Accordingly, even if FDA approval
is obtained for LFA, it may not gain acceptance by the medical field or become commercially
successful.
The eventual FDA approval and subsequent marketing and sale of our drug candidate LFA may be
adversely affected by the marketing and sale efforts of third parties who sell LFA outside North
America.
We have only licensed the rights to develop, market and sell LFA in North America. Other
companies, such as Wyeth and Sanofi-Aventis Inc., market and sell LFA in other parts of the world.
If, as a result of their actions, negative publicity is associated with LFA, our own efforts to
successfully receive FDA approval for, and subsequently, market and sell LFA, may be adversely
impacted.
The development of our drug candidate, Ozarelix, may be adversely affected if the development
efforts of Zentaris GmbH, who retained certain rights to the product, are not successful.
Zentaris GmbH licensed the rights to us to develop and market Ozarelix in the United States,
Canada, Mexico and India. Zentaris may conduct its own clinical trials on Ozarelix for regulatory
approval in other parts of the world. We will not have control over Zentaris efforts in this area
and our own development efforts for Ozarelix may be adversely impacted if its efforts are not
successful.
From time to time, we may need to license patents, intellectual property and proprietary
technologies from third parties, which may be difficult or expensive to obtain.
We may need to obtain licenses to patents and other proprietary rights held by third parties
to successfully develop, manufacture and market our drug products. As an example, it may be
necessary to use a third partys proprietary technology to reformulate one of our drug products in
order to improve upon the capabilities of the drug product. If we are unable to timely obtain
these licenses on reasonable terms, our ability to commercially exploit our drug products may be
inhibited or prevented.
The inability to retain and attract key personnel could significantly hinder our growth strategy
and might cause our business to fail.
Our success depends upon the contributions of our key management and scientific personnel,
especially Dr. Rajesh C. Shrotriya, our Chairman, President and Chief Executive Officer and Dr.
Luigi Lenaz, our Chief Scientific Officer. Dr. Shrotriya has been President since 2000 and Chief
Executive Officer since 2002, and has spearheaded our business strategy. Dr. Lenaz was President
of our Oncology Division from November 2000 to February 2005
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and Chief Scientific Officer since February 2005, and has played a key role in the
identification and development of our proprietary drug candidates. The loss of the services of Dr.
Shrotriya, Dr. Lenaz or any other key personnel could delay or preclude us from achieving our
business objectives. Dr. Shrotriya has an employment agreement with us that will expire on
December 31, 2007, with automatic one-year renewals thereafter unless we, or Dr. Shrotriya, give
notice of intent not to renew at least 90 days in advance of the renewal date. Dr. Lenaz has an
employment agreement with us that will expire on July 1, 2008, with automatic one-year renewals
thereafter unless we, or Dr. Lenaz, give notice of intent not to renew at least 90 days in advance
of the renewal date.
We may also need substantial additional expertise in marketing, pharmaceutical drug
development and other areas in order to achieve our business objectives. Competition for qualified
personnel among pharmaceutical companies is intense, and the loss of key personnel, or the delay or
inability to attract and retain the additional skilled personnel required for the expansion of our
business, could significantly damage our business.
Our collaborations with outside scientists may be subject to change, which could limit our
access to their expertise.
We work with scientific advisors and collaborators at academic research institutions. These
scientists are not our employees and may have other commitments that would limit their availability
to us. If a conflict of interest between their work for us and their work for another entity
arises, we may lose their services. Although our scientific advisors and academic collaborators
sign agreements not to disclose our confidential information, it is possible that some of our
valuable proprietary knowledge may become publicly known through them.
We are dependent on third parties for marketing our proposed proprietary products. If we are
not able to secure favorable arrangements with such third parties, our business and financial
condition could be harmed.
We currently do not have the capability to market our drug products ourselves. We may seek to
secure favorable arrangements with third parties to promote and market our proposed proprietary
products. If we are not able to secure favorable commercial terms or arrangements with third
parties for marketing and promotion of our proposed proprietary products, we may choose to retain
promotional and marketing rights and seek to develop the commercial resources necessary to promote
or market or co-promote or co-market certain or all of our proprietary drug candidates to the
appropriate channels of distribution in order to reach the specific medical market that we are
targeting. We may not be able to enter into any partnering arrangements on this or any other
basis. If we are not able to secure favorable partnering arrangements, or are unable to develop
the appropriate resources necessary for the commercialization of our proposed proprietary products,
our business and financial condition could be harmed. In addition, we would be required to hire
additional employees or consultants, since our current employees have limited experience in these
areas. Sufficient employees with relevant skills may not be available to us. Any increase in the
number of our employees would increase our expense level, and could have an adverse effect on our
financial position.
In addition, we, or our potential commercial partners, may not successfully introduce our
proposed proprietary products or our proposed proprietary products may not achieve acceptance by
patients, health care providers and insurance companies. To the extent that our corporate partners
conduct clinical trials, we may not be able to control the design and conduct of these clinical
trials.
We rely on contract research organizations and other third parties to conduct clinical trials
and, in such cases, we are unable to directly control the timing, conduct and expense of our
clinical trials.
We may rely, in full or in part, on third parties to conduct our clinical trials. In such
situations, we have less control over the conduct of our clinical trials, the timing and completion
of the trials, the required reporting of adverse events and the management of data developed
through the trial than would be the case if we were relying entirely upon our own staff.
Communicating with outside parties can also be challenging, potentially leading to mistakes as well
as difficulties in coordinating activities. Outside parties may have staffing difficulties, may
undergo changes in priorities or may become financially distressed, adversely affecting their
willingness or ability to conduct our trials. We may experience unexpected cost increases that are
beyond our control. Problems with the timeliness or quality of the work of a contract research
organization may lead us to seek to terminate the relationship
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and use an alternative service provider. However, making this change may be costly and may
delay our trials, and contractual restrictions may make such a change difficult or impossible.
Additionally, it may be impossible to find a replacement organization that can conduct our trials
in an acceptable manner and at an acceptable cost.
Conflicts with our partners could delay or prevent the development or commercialization of our
product candidates.
We may have conflicts with our partners, such as conflicts concerning the interpretation of
preclinical or clinical data, the achievement of milestones, the interpretation of contractual
obligations, payments for services, development obligations or the ownership of intellectual
property developed during our collaboration. If any conflicts arise with any of our partners, such
partner may act in a manner that is adverse to our best interests. Any such disagreement could
result in one or more of the following, each of which could delay or prevent the development or
commercialization of our product candidates, and in turn prevent us from generating revenues:
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unwillingness on the part of a partner to pay us milestone payments or royalties
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uncertainty regarding ownership of intellectual property rights arising from our
collaborative activities, which could prevent us from entering into additional
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unwillingness by a partner to cooperate in the development or manufacture of the
product, including providing us with product data or materials; |
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unwillingness on the part of a partner to keep us informed regarding the
progress of its development and commercialization activities or to permit public
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initiation of litigation or alternative dispute resolution options by either
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Our efforts to acquire or in-license and develop additional proprietary drug candidates may
fail, which would limit our ability to grow our proprietary business.
The long-term success of our strategy depends in part on our ability to acquire or in-license
drug candidates in addition to those drug candidates currently in our existing portfolio. We are
actively seeking to acquire, or in-license, additional proprietary drug candidates that demonstrate
the potential to be both medically and commercially viable. We have certain criteria that we are
looking for in any drug candidate acquisition and we may not be successful in locating and
acquiring, or in-licensing, additional desirable drug candidates on acceptable terms. In addition,
many other large and small companies within the pharmaceutical and biotechnology industry seek to
establish collaborative arrangements for product research and development, or otherwise acquire
products in late-stage clinical development, in competition with us. We face additional
competition from public and private research organizations, academic institutions and governmental
agencies in establishing collaborative arrangements for product candidates in late-stage clinical
development. Many of the companies and institutions that compete against us have substantially
greater capital resources, research and development staffs and facilities than we have, and greater
experience in conducting business development activities. These entities represent significant
competition to us as we seek to expand our pipeline through the in-license or acquisition of
compounds. Moreover, while it is not feasible to predict the actual cost of acquiring additional
product candidates, that cost could be substantial and we may need to raise additional financing or
issue additional equity securities, either of which may further dilute holdings of existing
stockholders, in order to acquire new product candidates.
S-11
We are a small company relative to our principal competitors, and our limited financial
resources may limit our ability to develop and market our drug products.
Many companies, both public and private, including well-known pharmaceutical companies and
smaller niche-focused companies, are developing products to treat many, if not all, of the diseases
we are pursuing or are currently distributing or may be developing drug products that directly
compete with the drugs we intend to develop, market and distribute. Many of these companies have
substantially greater financial, research and development, manufacturing, marketing and sales
experience and resources than us. As a result, our competitors may be more successful than us in
developing their products, obtaining regulatory approvals and marketing their products to
consumers.
Competition for branded or proprietary drugs is less driven by price and is more focused on
innovation in treatment of disease, advanced drug delivery and specific clinical benefits over
competitive drug therapies. We have nine proprietary drug candidates currently under development.
We may not be successful in any or all of these studies; or if successful, and if one or more of
our proprietary drug candidates is approved by the FDA, we may encounter direct competition from
other companies who may be developing products for similar or the same indications as our drug
candidates. Companies that have products on the market or in research and development that target
the same indications as our products target include Ardana Bioscience, Astra Zeneca LP, Amgen,
Inc., Bayer AG, Bioniche Life Sciences Inc., Eli Lilly and Co., Ferring Pharmaceuticals, NeoRx
Corporation, Genentech, Inc., Novartis Pharmaceuticals Corporation, Bristol-Myers Squibb Company,
GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc., Cephalon, Inc.,
Sanofi-Aventis Inc., Pfizer, Inc., AVI Biopharma, Inc., Chiron Corp., Genta Inc., Genzyme
Corporation, Imclone Systems Incorporated, Millennium Pharmaceuticals, MGI Pharma, Inc., SuperGen,
Inc., Shire Pharmaceuticals, TAP Pharmaceuticals, Inc., QLT Inc., Threshold Pharmaceuticals, Inc.,
Roche Pharmaceuticals, Schering-Plough, Johnson & Johnson and others who may be more advanced in
development of competing drug candidates or are more established and are currently marketing
products for the treatment of various indications that our drug candidates target. Many of our
competitors are large and well-capitalized companies focusing on a wide range of diseases and drug
indications, and have substantially greater financial, research and development, marketing, human
and other resources than we do. Furthermore, large pharmaceutical companies have significantly
more experience than we do in pre-clinical testing, human clinical trials and regulatory approval
procedures, among other things.
Our proprietary drug candidates may not be more effective, safer or more cost-efficient than
competing drugs and otherwise may not have any competitive advantage, which could hinder our
ability to successfully commercialize our drug candidates.
Any proprietary product for which we obtain FDA approval must compete for market acceptance
and market share. Drugs produced by other companies are currently on the market for each disease
type we are pursuing. Even if one or more of our drug candidates ultimately receive FDA approval,
our drug candidates may not have better efficacy in treating the target indication than a competing
drug, may not have a more favorable side-effect profile than a competing drug, may not be more
cost-efficient to manufacture or apply, or otherwise may not demonstrate a competitive advantage
over competing therapies. Accordingly, even if FDA approval is obtained for one or more of our
drug candidates, they may not gain acceptance by the medical field or become commercially
successful.
Our supply of drug products will be dependent upon the production capabilities of CMOs and
component and packaging supply sources, which may limit our ability to meet demand for our
products and ensure regulatory compliance or maximize profit on the sale of our products.
We have no internal manufacturing capacity for our drug product candidates, and, therefore, we
have entered into agreements with CMOs to supply us with active pharmaceutical ingredients and our
finished dose drug products, subject to further agreement on pricing for particular drug products.
Consequently, we will be dependent on our CMO partners for our supply of drug products. Some of
these manufacturing facilities are located outside the United States. The manufacture of finished
drug products, including the acquisition of compounds used in the manufacture of the finished drug
product, may require considerable lead times. We will have little or no control over the
production process. Accordingly, while we do not currently anticipate shortages of supply, there
could arise circumstances in which we will not have adequate clinical supplies to timely meet our
clinical development
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objectives or market demand for a particular drug product could outstrip the ability of our
supply source to timely manufacture and deliver the product, thereby causing us to lose sales. In
addition, our ability to make a profit on the sale of our drug products depends on our ability to
obtain transfer price arrangements that ensure a supply of product at favorable prices.
Reliance on CMOs entails risks to which we would not be subject if we manufactured products
ourselves, including reliance on the third party for regulatory compliance and adherence to the
FDAs current Good Manufacturing Practices, or cGMP, requirements, the possible breach of the
manufacturing agreement by the CMO because of factors beyond our control and the possibility of
termination or non-renewal of the agreement by the CMO, based on its own business priorities, at a
time that is costly or inconvenient for us. Before we can obtain marketing approval for our
product candidates, our CMO facilities must pass an FDA pre-approval inspection. In order to
obtain approval, all of the facilitys manufacturing methods, equipment and processes must comply
with cGMP requirements. The cGMP requirements govern all areas of record keeping, production
processes and controls, personnel and quality control. Any failure of our third party
manufacturers or us to comply with applicable regulations, including an FDA pre-approval inspection
and cGMP requirements, could result in sanctions being imposed on us, including fines, injunctions,
civil penalties, failure of regulatory authorities to grant marketing approval of our products,
delay, suspension or withdrawal of approvals, license revocation, seizures or recalls of product,
operation restrictions and criminal prosecutions, any of which could significantly and adversely
affect our business.
We may not be successful in establishing additional active pharmaceutical ingredient or finished
dose drug supply relationships, which would limit our ability to develop and market our drug
products.
Success in the development and marketing of our drugs depends in part upon our ability to
maintain, expand and enhance our existing relationships and establish new sources of supply for
active pharmaceutical ingredients, or API, or for the manufacture of our finished dose drug
products. We do not presently intend to focus our research and development efforts on developing
active pharmaceutical ingredients or manufacturing of dosage form for our drugs. In addition, we
currently have no capacity to manufacture APIs or finished dose drug products and do not intend to
spend our capital resources to develop the capacity to do so. Therefore, we must rely on
relationships with API suppliers and other CMOs, to supply our active pharmaceutical ingredients
and finished dose generic drug products. We may not be successful in maintaining, expanding or
enhancing our existing relationships or in securing new relationships with API suppliers or CMOs.
If we fail to maintain or expand our existing relationships or secure new relationships, our
ability to develop and market our drug products will be harmed.
We are dependent on a third party to market, sell and distribute our generic product sumatriptan
injection.
We have a development and marketing agreement with Par whereby Par has agreed to market, sell
and distribute sumatriptan injection generic product. While we have responsibility for the
development activities associated with sumatriptan injection, Par has the ultimate responsibility
for the selling and marketing of the products, and, therefore, the success of our sumatriptan
injection generic products depends upon the specific selling and marketing efforts undertaken by
Par. Par may not be successful in its marketing, which may adversely affect our ability to
commercially exploit the product.
Intense competition from a large number of generic companies may make the marketing and sale of
our generic drugs not commercially feasible and not profitable.
We will be competing against generic companies such as Teva Pharmaceuticals, Sandoz, Barr
Laboratories, Mylan Laboratories Inc., Watson Pharmaceuticals, Inc., Genpharm, Dr. Reddys,
Ranbaxy, American Pharmaceutical Partners, Bedford Laboratories, Mayne Pharmaceuticals and others.
In addition, we anticipate that many foreign manufacturers will continue to enter the generic
market due to low barriers to entry. These companies may have greater economies of scale in the
production of their products and, in certain cases, may produce their own product supplies, such as
active pharmaceutical ingredients, or can procure product supplies on more favorable terms which
may provide significant cost and supply advantages to customers in the retail prescription market.
We expect that the generic market will be competitive and will be largely dominated by the
competitors listed above who will target many, if not all, of the same products for development as
us.
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Price and other competitive pressures may make the marketing and sale of our generic drugs not
commercially feasible and not profitable.
The generic drug market in the United States is extremely competitive, characterized by many
domestic and foreign participants and constant downward price pressure on generic drug prices. Our
ability to compete effectively in the generic drug market depends largely on our ability to obtain
transfer price agreements that ensure a supply of our generic drug products at favorable prices.
Even if we obtain regulatory approval to market our generic drug candidates in the United States,
we may not be able to complete a transfer price arrangement with the manufacturers of the drug
candidates that will allow us to market the generic drug products in the United States on terms
favorable to us, or at all.
Risks Related to Our Industry
Rapid bio-technological advancement may render our drug candidates obsolete before we are able
to recover expenses incurred in connection with their development. As a result, our drug
products may never become profitable.
The pharmaceutical industry is characterized by rapidly evolving biotechnology.
Biotechnologies under development by other pharmaceutical companies could result in treatments for
diseases and disorders for which we are developing our own treatments. Several other companies are
engaged in research and development of compounds that are similar to our research. A competitor
could develop a new biotechnology, product or therapy that has better efficacy, a more favorable
side-effect profile or is more cost-effective than one or more of our drug candidates and thereby
cause our drug candidate to become commercially obsolete. Some of our drug candidates may become
obsolete before we recover the expenses incurred in their development. As a result, such products
may never become profitable.
Competition for patients in conducting clinical trials may prevent or delay product development
and strain our limited financial resources.
Many pharmaceutical companies are conducting clinical trials in patients with the disease
indications that our drug candidates target. As a result, we must compete with them for clinical
sites, physicians and the limited number of patients who fulfill the stringent requirements for
participation in clinical trials. Also, due to the confidential nature of clinical trials, we do
not know how many of the eligible patients may be enrolled in competing studies and who are
consequently not available to us for our clinical trials. Our clinical trials may be delayed or
terminated due to the inability to enroll enough patients to complete our clinical trials. Patient
enrollment depends on many factors, including the size of the patient population, the nature of the
trial protocol, the proximity of patients to clinical sites and the eligibility criteria for the
study. The delay or inability to meet planned patient enrollment may result in increased costs and
delays or termination of the trial, which could have a harmful effect on our ability to develop
products.
We may not be successful in obtaining regulatory approval to market and sell our proprietary or
generic drug candidates.
Before our proprietary drug candidates can be marketed and sold, regulatory approval must be
obtained from the FDA and comparable foreign regulatory agencies. We must demonstrate to the FDA
and other regulatory authorities in the United States and abroad that our product candidates
satisfy rigorous standards of safety and efficacy. We will need to conduct significant additional
research, pre-clinical testing and clinical testing, before we can file applications with the FDA
for approval of our product candidates. The process of obtaining FDA and other regulatory
approvals is time consuming, expensive, and can be difficult to design and implement. The review
and approval, or denial, process for an application can take years. The FDA, or comparable foreign
regulatory agencies, may not timely, or ever, approve an application. Among the many
possibilities, the FDA may require substantial additional testing or clinical trials or find our
drug candidate is not sufficiently safe or effective in treating the targeted disease.
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This could result in the denial or delay of product approval. Our product development costs
will increase if we experience delays in testing or approvals. Further, a competitor may develop a
competing drug or therapy that impairs or eliminates the commercial feasibility of our drug
candidates.
In order to obtain approval for our generic drug candidates, we will need to scientifically
demonstrate that our drug product is safe and bioequivalent to the innovator drug. The FDA may not
agree that our safety and bioequivalence studies provide sufficient support for approval. This
could result in denial or delay of FDA approval of our generic products. Generic drugs generally
have a relatively short window in which they can be profitable before other manufacturers introduce
competing products that impose downward pressure on prices and reduce market share for other
versions of the generic drug. Consequently, delays in obtaining FDA approval may also
significantly impair our ability to compete.
Our failure to comply with governmental regulations may delay or prevent approval of our product
candidates and/or subject us to penalties.
The FDA and comparable agencies in foreign countries impose many requirements on the
introduction of new drugs through lengthy and detailed clinical testing and data collection
procedures, and other costly and time consuming compliance procedures. While we believe that we
are currently in compliance with applicable FDA regulations, if our partners, our contract research
organizations, our contract manufacturing organizations or we fail to comply with the regulations
applicable to our clinical testing, the FDA may delay, suspend or cancel our clinical trials, or
the FDA might not accept the test results. The FDA, an institutional review board at our clinical
trial sites, our third party investigators, any comparable regulatory agency in another country, or
we, may suspend clinical trials at any time if the trials expose subjects participating in such
trials to unacceptable health risks. Further, human clinical testing may not show any current or
future product candidate to be safe and effective to the satisfaction of the FDA or comparable
regulatory agencies or the data derived from the clinical tests may be unsuitable for submission to
the FDA or other regulatory agencies.
Once we submit a drug candidate for commercial sale approval, the FDA or other regulatory
agencies may not issue their approvals on a timely basis, if at all. If we are delayed or fail to
obtain these approvals, our business and prospects may be significantly damaged. Even if we obtain
regulatory approval for our product candidates, we, our partners, our manufacturers, and other
contract entities will continue to be subject to extensive requirements by a number of national,
foreign, state and local agencies. These regulations will impact many aspects of our operations,
including testing, research and development, manufacturing, safety, effectiveness, labeling,
storage, quality control, adverse event reporting, record keeping, approval, advertising and
promotion of our future products. Failure to comply with applicable regulatory requirements could,
among other things, result in:
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fines; |
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changes in advertising; |
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revocation or suspension of regulatory approvals of products; |
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product recalls or seizures; |
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delay, interruption, or suspension of product distribution, marketing and sale; |
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civil or criminal sanctions; and |
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refusals to approve new products. |
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The discovery of previously unknown problems with drug products approved to go to market may
raise costs or prevent us from marketing such product.
The later discovery of previously unknown problems with our products may result in
restrictions of the product candidate, including withdrawal from manufacture. In addition, the FDA
may revisit and change its prior
determinations with regard to the safety and efficacy of our future products. If the FDAs
position changes, we may be required to change our labeling or to cease manufacture and marketing
of the challenged products. Even prior to any formal regulatory action, we could voluntarily
decide to cease the distribution and sale or recall any of our future products if concerns about
their safety or effectiveness develop.
Our failure to comply with advertising regulations enforced by the FDA and the Federal Trade
Commission may subject us to sanctions, damage our reputation and adversely affect our business
condition.
In their regulation of advertising, the FDA and the Federal Trade Commission from time to time
issue correspondence alleging that some advertising or promotional practices are false, misleading
or deceptive. The FDA has the power to impose a wide array of sanctions on companies for such
advertising practices, and the receipt of correspondence from the FDA alleging these practices
could result in any of the following:
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incurring substantial expenses, including fines, penalties, legal fees and costs
to comply with the FDAs requirements; |
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changes in the methods of marketing and selling products; |
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taking FDA-mandated corrective action, which may include placing advertisements
or sending letters to physicians, rescinding previous advertisements or promotions;
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disruption in the distribution of products and loss of sales until compliance
with the FDAs position is obtained. |
If we were to become subject to any of the above requirements, it could be damaging to our
reputation, and our business condition could be adversely affected.
Physicians may prescribe pharmaceutical products for uses that are not described in a
products labeling or differ from those tested by us and approved by the FDA. While such
off-label uses are common and the FDA does not regulate physicians choices of treatments, the
FDA does restrict a manufacturers communications on the subject of off-label use. Companies
cannot actively promote FDA-approved pharmaceutical products for off-label uses, but they may
disseminate to physicians articles published in peer-reviewed journals. If our promotional
activities fail to comply with the FDAs regulations or guidelines, we may be subject to warnings
from, or enforcement action by, the FDA.
Legislative or regulatory reform of the healthcare system and pharmaceutical industry may hurt
our ability to sell our products profitably or at all.
In both the United States and certain foreign jurisdictions, there have been and may continue
to be a number of legislative and regulatory proposals to change the healthcare system and
pharmaceutical industry in ways that could impact our ability to sell our products profitably.
Sales of our products depend in part on the availability of reimbursement from third party payers
such as government health administration authorities, private health insurers, health maintenance
organizations including pharmacy benefit managers and other healthcare-related organizations. Both
the federal and state governments in the United States and foreign governments continue to propose
and pass new legislation, rules and regulations designed to contain or reduce the cost of
healthcare, including the Medicare Prescription Drug, Improvement and Modernization Act of 2003,
and the Medicare Modernization Act, which was recently enacted. This legislation provides a new
Medicare prescription drug benefit which began in 2006 and mandates other reforms. Also, the
passage of the Medicare Modernization Act reduces reimbursement for certain drugs used in the
treatment of cancer. The new benefit, which will be managed by private health insurers, pharmacy
benefit managers and other managed care organizations, may result in decreased reimbursement for
prescription drugs, which may further exacerbate industry-wide pressure to reduce the prices
charged for prescription drugs. This could harm our ability to market our products and generate
revenues.
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It is possible that other proposals will be adopted or existing regulations that affect the
price of pharmaceutical and other medical products may also change before any of our products are
approved for marketing. Cost control initiatives could decrease the price that we receive for any of our products that
we are developing. In addition, third party payers are increasingly challenging the price and
cost-effectiveness of medical products and services. Significant uncertainty exists as to the
reimbursement status of newly-approved pharmaceutical products. Our products may not be
considered cost-effective, or adequate third party reimbursement may not be available to enable us
to maintain price levels sufficient to realize a return on our investments.
In addition, new court decisions, FDA interpretations, and legislative changes have modified
the rules governing eligibility for and the timing of 180-day market exclusivity periods, a period
of marketing exclusivity that the FDA may grant to an ANDA applicant who is the first to file a
legal challenge to patents of branded drugs. Any changes in the Hatch-Waxman Act, FDA regulations,
procedures, or interpretations may make ANDA approvals of generic drugs more difficult, limit the
benefits available through the granting of 180-day marketing exclusivity or limit our ability to
market authorized generic versions of branded products.
As part of the Medicare Modernization Act, companies are now required to file with the Federal
Trade Commission and the Department of Justice certain types of agreements entered into between
branded and generic pharmaceutical companies related to the manufacture, marketing and sale of
generic versions of branded drugs. This new requirement could affect the manner in which generic
drug manufacturers resolve intellectual property litigation and other disputes with branded
pharmaceutical companies, and could result generally in an increase in private-party litigation
against pharmaceutical companies. The impact of this new requirement, and the potential
private-party lawsuits associated with arrangements between brand name and generic drug
manufacturers, could adversely affect our business.
Additional government regulations, legislation, or policies may be enacted which could prevent
or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature
or extent of adverse government action that may arise from future legislation or administrative
action, either in the United States or abroad. If we are not able to maintain regulatory
compliance, we might not be permitted to market our products and our business could suffer.
Our corporate compliance program may not ensure that we are in compliance with all applicable
fraud and abuse laws and regulations, and a failure to comply with such regulations or prevail
in litigation related to noncompliance could harm our business.
Pharmaceutical and biotechnology companies have faced lawsuits and investigations pertaining
to violations of healthcare fraud and abuse laws, such as the federal false claims act, the
federal anti-kickback statute, and other state and federal laws and regulations. While we have
developed and implemented a corporate compliance program based upon what we believe are the
relevant current best practices, we cannot guarantee that this program will protect us from future
lawsuits or investigations. If any such actions are instituted against us, and we are not
successful in defending ourselves or asserting our rights, those actions could have a significant
impact on our business, including the imposition of significant fines or other sanctions.
We may not be able to adequately protect our technology or enforce our patent rights, which
could cause our business to suffer.
Our success with proprietary products that we develop will depend, in part, on our ability to
obtain and maintain patent protection for these products. We currently have a number of United
States and foreign patents issued and pending; however, we primarily rely on patent rights licensed
from others. These patents generally give us the right and/or obligation to maintain and enforce
the subject patents. We cannot be sure that we will receive patents for any of our pending patent
applications or any patent applications we may file in the future. If our pending and future
patent applications are not approved or, if approved, if such patents and the patents we have
licensed are not upheld in a court of law, our ability to competitively exploit our proprietary
products would be substantially harmed. Also, such patents may or may not provide competitive
advantages for their respective products or they may be challenged or circumvented by our
competitors, in which case our ability to commercially exploit these products may be diminished.
S-17
We also rely on trade secret protection and contractual protections for our unpatented,
confidential and proprietary technology. Trade secrets are difficult to protect. While we enter
into proprietary information
agreements with our employees, consultants and others, these agreements may not successfully
protect our trade secrets or other confidential and proprietary information. It is possible that
these agreements will be breached, or that they will not be enforceable in every instance, and that
we will not have adequate remedies for any such breach. It is also possible that our trade secrets
will become known or independently developed by our competitors.
If we are unable to adequately protect our technology, trade secrets or proprietary know-how,
or enforce our patents, our business, financial condition and prospects could suffer.
Intellectual property rights are complex and uncertain and therefore may subject us to
infringement claims.
The patent positions related to our proprietary and generic drug candidates are inherently
uncertain and involve complex legal and factual issues. Although we are not aware of any
infringement by any of our drug candidates on the rights of any third party, there may be third
party patents or other intellectual property rights relevant to our drug candidates of which we are
not aware. Third parties may assert patent or other intellectual property infringement claims
against us with respect to our proprietary drug candidates or our generic drug products. This
could draw us into costly litigation as well as result in the loss of our use of the intellectual
property that is critical to our business strategy.
Intellectual property litigation is increasingly common and increasingly expensive and may
result in restrictions on our business and substantial costs, even if we prevail.
Patent and other intellectual property litigation is becoming more common in the
pharmaceutical industry. Litigation is sometimes necessary to defend against or assert claims of
infringement, to enforce our patent rights, including those we have licensed from others, to
protect trade secrets or to determine the scope and validity of proprietary rights of third
parties. Currently no third party is asserting that we are infringing upon its patent rights or
other intellectual property, nor are we aware or believe that we are infringing upon any third
partys patent rights or other intellectual property. We may, however, be infringing upon a third
partys patent rights or other intellectual property, and litigation asserting such claims might be
initiated in which we would not prevail, or we would not be able to obtain the necessary licenses
on reasonable terms, if at all. All such litigation, whether meritorious or not, as well as
litigation initiated by us against third parties, is time-consuming and very expensive to defend or
prosecute and to resolve. In addition, if it is determined that we have infringed the intellectual
property rights of others, we could lose our right to develop, manufacture or sell our products or
could be required to pay monetary damages or royalties to license proprietary rights from third
parties. An adverse determination in a judicial or administrative proceeding or a failure to
obtain necessary licenses could prevent us from manufacturing or selling our products, which could
harm our business, financial condition and prospects.
If our competitors prepare and file patent applications in the United States that claim
technology we also claim, we may have to participate in interference proceedings required by the
USPTO to determine priority of invention, which could result in substantial costs, even if we
ultimately prevail. Results of interference proceedings are highly unpredictable and may result in
us having to try to obtain licenses in order to continue to develop or market certain of our drug
candidates.
We may be subject to product liability claims, and may not have sufficient product liability
insurance to cover any such claims, which may expose us to substantial liabilities.
We may be exposed to product liability claims from patients who participate in our clinical
trials or from consumers of our products. Although we currently carry product liability insurance
in the amount of at least $10 million in the aggregate, it is possible that this coverage will be
insufficient to protect us from future claims.
Further, we may not be able to maintain our existing insurance or obtain or maintain
additional insurance on acceptable terms for our clinical and commercial activities or such
additional insurance might be insufficient to cover any potential product liability claim or
recall. Failure to maintain sufficient insurance coverage could have a material adverse effect on
our business, prospects and results of operations if claims are made that exceed our coverage.
S-18
The use of hazardous materials in our research and development efforts imposes certain
compliance costs on us and may subject us to liability for claims arising from the use or misuse
of these materials.
Our research and development efforts have involved and currently involve the use of hazardous
materials. We are subject to federal, state and local laws and regulations governing the storage,
use and disposal of these materials and some waste products. We believe that our safety procedures
for the storage, use and disposal of these materials comply with the standards prescribed by
federal, state and local regulations. However, we cannot completely eliminate the risk of
accidental contamination or injury from these materials. If there were to be an accident, we could
be held liable for any damages that result, which could exceed our financial resources. We
currently maintain insurance coverage for injuries resulting from the hazardous materials we use,
and for pollution clean up and removal; however, future claims may exceed the amount of our
coverage. Currently the costs of complying with federal, state and local regulations are not
significant, and consist primarily of waste disposal expenses.
Risks Related to Our Stock
There are a substantial number of shares of our common stock eligible for future sale in the
public market. The sale of these shares could cause the market price of our common stock to
fall. Any future equity issuances by us may have dilutive and other effects on our existing
stockholders.
As of April 27, 2007, there were approximately 25.7 million shares of our common stock
outstanding, and in addition, security holders held restricted stock, options, warrants and
preferred stock which, if vested, exercised or converted, would obligate us to issue up to
approximately 15 million additional shares of common stock. However, we would receive over $80
million from the issuance of shares of common stock upon the exercise of all of the option and
warrants. A substantial number of those shares, when we issue them upon vesting, conversion or
exercise, will be available for immediate resale in the public market.
We have financed our operations, and we anticipate that we will have to finance a large
portion of our operating cash requirements, primarily by issuing and selling our common stock or
securities convertible into or exercisable for shares of our common stock. Any issuances by us of
equity securities may be at or below the prevailing market price of our common stock and may have a
dilutive impact on our existing stockholders. These issuances would also cause our net income, if
any, per share to decrease or our loss per share to decrease in future periods. As a result, the
market price of our common stock could drop.
The market price and volume of our common stock fluctuate significantly and could result in
substantial losses for individual investors.
The stock market from time to time experiences significant price and volume fluctuations that
are unrelated to the operating performance of particular companies. These broad market
fluctuations may cause the market price and volume of our common stock to decrease. In addition,
the market price and volume of our common stock is highly volatile. Factors that may cause the
market price and volume of our common stock to decrease include fluctuations in our results of
operations, timing and announcements of our bio-technological innovations or new products or those
of our competitors, FDA and foreign regulatory actions, developments with respect to patents and
proprietary rights, public concern as to the safety of products developed by us or others, changes
in healthcare policy in the United States and in foreign countries, changes in stock market analyst
recommendations regarding our common stock, the pharmaceutical industry generally and general
market conditions. In addition, the market price and volume of our common stock may decrease if
our results of operations fail to meet the expectations of stock market analysts and investors.
Also, certain dilutive securities such as warrants can be used as hedging tools which may increase
volatility in our stock and cause a price decline. While a decrease in market price could result
in direct economic loss for an individual investor, low trading volume could limit an individual
investors ability to sell our common stock, which could result in substantial economic loss as
well.
S-19
Provisions of our certificate of incorporation, bylaws and stockholder rights plan may make it
more difficult for someone to acquire control of us or replace current management even if doing
so would benefit our stockholders, which may lower the price an acquirer or investor would pay
for our stock.
Provisions of our certificate of incorporation and bylaws, both as amended, may make it more
difficult for someone to acquire control of us or replace our current management. These provisions
include:
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the ability of our board of directors to amend our bylaws without stockholder approval; |
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the inability of stockholders to call special meetings; |
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the ability of members of the board of directors to fill vacancies on the board of directors; |
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the inability of stockholders to act by written consent, unless such consent is unanimous; and |
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the establishment of advance notice requirements for nomination for election to
our board of directors or for proposing matters that can be acted on by
stockholders at stockholder meetings. |
These provisions may make it more difficult for stockholders to take certain corporate actions
and could delay, discourage or prevent someone from acquiring our business or replacing our current
management, even if doing so would benefit our stockholders. These provisions could limit the
price that certain investors might be willing to pay for shares of our common stock.
We have a stockholder rights plan pursuant to which we distributed rights to purchase units of
our series B junior participating preferred stock. The rights become exercisable upon the earlier
of ten days after a person or group of affiliated or associated persons has acquired 15% or more of
the outstanding shares of our common stock or ten business days after a tender offer has commenced
that would result in a person or group beneficially owning 15% or more of our outstanding common
stock. These rights could delay or discourage someone from acquiring our business, even if doing
so would benefit our stockholders. We currently have no stockholders who own 15% or more of the
outstanding shares of our common stock.
We do not anticipate declaring any cash dividends on our common stock.
We have never declared or paid cash dividends on our common stock and do not plan to pay any
cash dividends on our common stock in the near future. Our current policy is to retain all funds
and any earnings for use in the operation and expansion of our business.
USE OF PROCEEDS
The Company will use the net proceeds of the offering for general corporate purposes,
including working capital, capital expenditures, research and development, general and
administrative expenses and acquisitions of rights to new products. Our management will have broad
discretion respecting the particular uses of the proceeds of the offering. Pending use, the
net proceeds will be invested in short-term securities. We are not under any contractual or other
obligation, nor do we expect, to pay any dividends or distribute any of the net proceeds from this
offering to our stockholders.
DILUTION
The net tangible book value of our
common stock on March 31, 2007, after giving pro-forma effect to
the issuance on April 16, 2007 of 207,957 shares of our
common stock upon the conversion of 48 shares of our
Series D 8% Cumulative Convertible Voting Preferred Stock by an
institutional investor, at a conversion price of $2.35 per share
(we received no additional consideration for this conversion), was
approximately $37.2 million, or approximately $1.47 per share. Net tangible book value per share represents the amount
of our total tangible assets, less our total liabilities and the aggregate liquidation preference
of our preferred stock outstanding, divided by the total number of shares of our common stock
outstanding. Dilution in net tangible book value per share to new investors represents the
difference between the amount per share paid by purchasers of shares of our common stock
S-20
in the offering and the net tangible book value per share of our common stock immediately
afterwards. Without taking into account any other changes in net tangible book value after March
31, 2007, our net tangible book value would have been approximately
$69.3 million, or approximately
$2.28 per share. This represents an immediate accretion in net tangible book value of
approximately $0.81 per share to existing stockholders and an immediate dilution in net tangible
book value of approximately $3.97 per share to new investors.
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Offering price per share |
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$6.25 |
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Net tangible book value per share |
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$1.47 |
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Increase per share attributable to new investors |
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$0.81 |
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As adjusted net tangible book value per share after the offering |
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$2.28 |
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Decrease in net tangible book value per share to new investors |
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$3.97 |
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This table excludes shares of common stock issuable upon exercise of options, warrants and
other rights, the conversion of preferred stock, and the effect of shares of common stock issued,
except as indicated above, since March 31, 2007. The number of shares of our common stock
outstanding may be increased by shares issued upon conversion of preferred stock, payment of
dividends, exercise of warrants or exercise of options, and, to the extent warrants and options are
exercised for cash, the net tangible book value of our common stock may increase.
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 Certificate of Incorporation and
Bylaws, copies of which are on file with the SEC. See Where You Can Find More Information.
We have authority to issue 100,000,000 shares of common stock, $0.001 par value per share. As
of April 27, 2007, we had 25,670,721 shares of common stock outstanding and 170 shares of Series E
Convertible Voting Preferred stock outstanding.
Terms
Holders of our common stock are entitled to one vote per share on all matters to be voted upon
by the stockholders. The holders of common stock are not entitled to cumulative voting rights with
respect to election of directors, and as a consequence, minority stockholders will not be able to
elect directors on the basis of their shares alone. Our Board of
Directors currently consists of six directors, each of whom is
elected annually.
Subject to any dividend preferences that may be applicable to the holders of any class of our
preferred stock, if any, the holders of our common stock are entitled to receive ratably such
lawful dividends as may be declared by the Board of Directors.
In the event of liquidation, dissolution or winding up of Spectrum, before any distribution of
our assets shall be made to or set apart for the holders of our common stock, the holders of our
Series E Convertible Voting Preferred Stock shall be entitled to receive payment out of our assets
in an amount equal to the liquidation preference set forth in the Certificate of Designation for
such preferred stock. If the assets available for distribution to stockholders exceed the
aggregate amount of the liquidation preference with respect to all shares of the preferred stock
then outstanding, then the holders of our common stock shall be entitled to receive, subject to the
rights of the holders of any other class of our preferred stock, if any, pro rata all of our
remaining assets available for distribution to our stockholders.
Our common stock has no preemptive or conversion rights, other subscription rights, or
redemption or sinking fund provisions. All outstanding shares of our common stock are fully paid
and nonassessable. The rights, powers, preferences and privileges of holders of our common stock
are subject to, and may be adversely affected by, the rights of the holders of shares of any series
of preferred stock.
S-21
Stockholder Rights Plan
On December 13, 2000, we adopted a Stockholder Rights Plan pursuant to which we have
distributed rights to purchase units of our Series B Junior Participating Preferred Stock. The
rights become exercisable upon the earlier of ten days after a person or group of affiliated or
associated persons has acquired 15% or more of the outstanding shares of our common stock or ten
business days after a tender offer has commenced that would result in a person or group
beneficially owning 15% or more of our outstanding common stock, other than pursuant to a
transaction approved in advance by our Board of Directors. The description and terms of the rights
are set forth in the Rights Agreement between us and U.S. Stock Transfer Corporation, as rights
agent, filed with the SEC on December 26, 2000, as Exhibit 4.1 to our Form 8-A, as amended by
Amendment No. 1 dated July 23, 2003, filed with the SEC on August 14, 2003, as Exhibit 4.1 to our
Form 10-Q for the period ended June 30, 2003, by Amendments No. 2 and No. 3 each dated May 10,
2004, filed with the SEC on May 17, 2004, as Exhibit 4.1 and Exhibit 4.2, respectively, to our Form
10-Q for the period ended March 31, 2004, Amendment No. 4 dated July 7, 2006, filed with the SEC on
July 7, 2006, as Exhibit 4.1 to our Form 8-K, and by Amendment No. 5 dated September 26, 2006,
filed with the SEC on November 3, 2006, as Exhibit 4.2 to our Form 10-Q for the period ended
September 30, 2006.
Certain Provisions of Delaware Law and of the Companys Charter and Bylaws
The following paragraphs summarize certain provisions of the Delaware General Corporation Law
(DGCL) and the Companys Charter and Bylaws. The summary does not purport to be complete and is
subject to and qualified in its entirety by reference to the DGCL and to the Companys Charter and
Bylaws, copies of which are on file with the SEC. See Where You Can Find More Information.
Our Certificate of Incorporation and Bylaws contain provisions that, together with the
ownership position of the officers, directors and their affiliates, could discourage potential
takeover attempts and make it more difficult for stockholders to change management, which could
adversely affect the market price of our common stock.
Our Certificate of Incorporation limits the extent to which our directors are personally
liable to Spectrum and our stockholders, to the fullest extent permitted by the Delaware General
Corporation Law, or DGCL. The inclusion of this provision in our Certificate of Incorporation may
reduce the likelihood of derivative litigation against directors and may discourage or deter
stockholders or management from bringing a lawsuit against directors for breach of their duty of
care.
Our Bylaws provide that special meetings of stockholders can be called only by the Board of
Directors, the Chairman of the Board of Directors or the Chief Executive Officer. Stockholders are
not permitted to call a special meeting and cannot require the Board of Directors to call a special
meeting. There is no right of stockholders to act by written consent without a meeting, unless the
consent is unanimous. Any vacancy on the Board of Directors resulting from death, resignation,
removal or otherwise or newly created directorships may be filled only by vote of the majority of
directors then in office, or by a sole remaining director. Our Bylaws establish advance notice
procedures with respect to stockholder proposals and the nomination of candidates for election as
directors, except for nominations made by or at the direction of the Board of Directors or a
committee of the Board.
We are subject to the business combination statute of the DGCL, an anti-takeover law enacted
in 1988. In general, Section 203 of the DGCL prohibits a publicly-held Delaware corporation from
engaging in a business combination with an interested stockholder, for a period of three years
after the date of the transaction in which a person became an interested stockholder, unless:
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prior to such date our Board of Directors approved either the business
combination or the transaction which resulted in the stockholder becoming an
interested stockholder, |
S-22
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upon consummation of the transaction which resulted in the stockholder becoming
an interested stockholder, the interested stockholder owned at least 85% of the
voting stock of the corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares outstanding those shares
owned by (1) persons who are directors |
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and also officers and (2) employee stock plans in which employee participants do not
have the right to determine confidentially whether shares held subject to the plan
will be tendered in a tender or exchange offer, or |
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at or subsequent to such time the business combination is approved by the
board of directors and authorized at an annual or special meeting of stockholders,
and not by written consent, by the affirmative vote of a least 662/3% of
the outstanding voting stock which is not owned by the interested stockholder. |
A business combination includes mergers, stock or asset sales and other transactions
resulting in a financial benefit to the interested stockholders. An interested stockholder is
a person who, together with affiliates and associates, owns (or within three years, did own) 15% or
more of a corporations voting stock. Although Section 203 permits us to elect not to be governed
by its provisions, we have not made this election. As a result of the application of Section 203,
potential acquirers of Spectrum may be discouraged from attempting to effect an acquisition
transaction with us, thereby possibly depriving holders of our securities of certain opportunities
to sell or otherwise dispose of such securities at above-market prices pursuant to such
transactions.
The transfer agent and registrar for our common stock is U.S. Stock Transfer Corporation.
S-23
PLAN OF DISTRIBUTION
We are offering shares of our common stock through the Placement Agents. Subject to the terms
and conditions in a Placement Agent Agreement dated May 4, 2007, between the Company and Oppenheimer
& Co. Inc. (Oppenheimer), as representative of the Placement Agents. The Placement Agents will
use their best efforts to place up to 5,134,100 shares of our common stock. The Placement Agents
are not purchasing or selling any shares by this prospectus supplement or accompanying prospectus,
nor are they required to arrange for the purchase or sale of any specific number or dollar amount
of shares. We will enter into subscription agreements directly with the investors in connection
with the offering. We will pay the Placement Agents a cash commission of 6% of the gross proceeds
of the offering. Lazard Fréres & Co. LLC referred this
transaction to Lazard Capital Markets LLC and will receive a referral
fee from Lazard Capital Markets LLC in connection therewith.
We expect that the sale of up to 5,134,100 shares of our common stock will be completed on or
about May 9, 2007. We have entered into an escrow agreement dated May 4, 2007 with the Placement
Agents and JPMorgan Chase Bank, N.A., as escrow agent (the Escrow Agreement). Pursuant to the
Escrow Agreement, JPMorgan Chase Bank, N.A., will receive and hold funds from purchasers and
release them to us only upon closing.
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Per Share |
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Total |
Public Offering Price |
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$ |
6.25 |
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32,088,125 |
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Placement Agents Fees |
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.375 |
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1,925,288 |
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Proceeds to Us, Before Expenses |
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5.875 |
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30,162,838 |
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The estimated expenses of the offering,
not counting placement fees, are approximately $75,000,
which includes legal, accounting and printing costs and various other fees. After deducting
expenses and placement fees, we expect our net proceeds from the
offering to be approximately $30 million.
Because there is no minimum offering amount required as a condition to closing the offering, the
actual total proceeds may be less than the maximum total set forth above.
One or more of the Placement Agents may from time to time in the future engage in transactions
with us and perform services for us in the ordinary course of their business. The Placement Agents
have informed us that they will not engage in over-allotment, stabilizing transactions or syndicate
covering transactions in connection with this offering.
We have agreed, subject to certain limited exceptions, to a lock-up provision whereby we are
limited with regard to future sales, assignments, transfers, pledges,
contracts to sell any shares of common stock or securities convertible into or exercisable or
exchangeable for common stock for a period of 90 days after the completion of the offering. Our
executive officers and directors have also agreed, subject to certain limited exceptions, to
certain lock-up provisions with regard to future sales of our common stock and other securities
convertible or exchangeable for common stock for a period of 30 days after the completion of the
offering.
We have agreed to indemnify the Placement Agents against certain liabilities, including
liabilities under the Securities Act, and/or to contribute to payments the Placement Agents may be
required to make with respect to any of these liabilities.
Our common stock is traded on the Nasdaq Global Market under the symbol SPPI.
One or more of the Placement Agents participating in this offering may make prospectuses
available in electronic (PDF) format. A prospectus in electronic format may be made available on
the web sites maintained by one or more of the Placement Agents, or syndicate members, if any,
participating in this offering, and one or more of the Placement Agents participating in this
offering may distribute such prospectuses electronically.
S-24
LEGAL MATTERS
Gibson, Dunn & Crutcher LLP, Irvine, California, will opine on the validity of the securities
offered by this prospectus supplement. Certain legal matters will be passed upon for the Placement
Agents by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., New York, New York. Certain
intellectual property matters will be passed upon for us by Kirkpatrick & Lockhart Preston Gates
Ellis LLP, Irvine, California.
EXPERTS
The consolidated financial statements of the Company as of December 31, 2006, December 31,
2005, December 31, 2004 and December 31, 2003 incorporated by reference in this prospectus
supplement, have been audited by Kelly & Company, independent certified public accountants, as
indicated in their report with respect thereto, and are included herein in reliance upon the
authority of said firm as experts in accounting and auditing.
LIMITATION ON LIABILITY AND DISCLOSURE OF SEC POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Our Bylaws provide for indemnification of our directors and officers to the fullest extent
permitted by law. Insofar as indemnification for liabilities under the Securities Act of 1933 may
be permitted to directors, officers or controlling persons of the Company pursuant to the Companys
Certificate of Incorporation, as amended, bylaws and the Delaware General Corporation Law, the
Company has been informed that in the opinion of the SEC such indemnification is against public
policy as expressed in such Act and is therefore unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other information with the
SEC. You may read and copy any document we file at the SECs public reference room at 100 F
Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further
information on the operation of the public reference rooms. Our SEC filings are also available to
the public at the SECs web site at http://www.sec.gov.
The SEC 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
repeating the information in this prospectus supplement. The information incorporated by reference
is considered to be part of this prospectus supplement, and later information that we file with the
SEC will automatically update and supersede this information. We incorporate by reference the
documents listed below and any future filings made with the SEC under Section 13(a), 13(c), 14, or
15(d) of the Exchange Act until this offering is completed:
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Our annual report on Form 10-K for the fiscal year ended December 31, 2006,
filed on March 14, 2007, as amended by the Form 10-K/A filed on April 30, 2007; |
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Our quarterly report on Form 10-Q for the quarter ended March 31, 2007, filed on
May 2, 2007; |
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The description of our common stock contained in the Registration of Securities
of Certain Successor Issuers filed pursuant to Section 12(g) of the Exchange
Act on
Form 8-B on June 27, 1997, including any amendments or reports filed for the
purpose of updating such description; and |
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The description of our Rights to Purchase Series B Junior Participating
Preferred Stock contained in the Registration of Certain Classes of Securities
filed pursuant to Section 12(g) of the Exchange Act on Form 8-A on December 26,
2000, including any amendments or reports filed for the purpose of updating
such description. |
S-25
You can request a copy of these filings, at no cost, by writing or telephoning us at the following
address:
Spectrum Pharmaceuticals, Inc.
Attn: Investor Relations
157 Technology Drive
Irvine, California 92618
(949) 788-6700
S-26
SPECTRUM PHARMACEUTICALS, INC.
UP TO
5,134,100 SHARES OF COMMON STOCK
PROSPECTUS SUPPLEMENT
DATED MAY 4, 2007
S-27