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PROSPECTUS
SUPPLEMENT NO. 1
(TO PROSPECTUS DATED MAY 5, 2008)
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Filed pursuant to
Rule 424(b)(5)
Registration Statement No. 333-150260 |
The information in this prospectus supplement is not complete and may be changed.
A registration statement relating to these securities has been filed with the Securities and Exchange
Commission and has been declared effective. This prospectus supplement is not an offer to sell these securities and it is not soliciting an offer to buy
these securities in any state where the offer or sale is not permitted.
Subject to Completion; Dated March 23, 2009
Shares
Spectrum Pharmaceuticals, Inc.
Common Stock
We are offering to sell up to shares of our common stock to certain of our employees
that elect to purchase shares of our common stock in conjunction with a publicly announced offer to
repurchase certain outstanding options, which we refer to as the Offer. The sale and purchase of
the shares under this prospectus supplement will occur within three business days after the
expiration of the Offer at the closing price of our common stock on that day.
Our common stock is listed on the Nasdaq Global Market under the symbol SPPI. On March 20,
2009, the last reported sale price of our common stock on the Nasdaq
Global Market was $1.50 per
share.
We are unable to determine the specific number of shares of our common stock to be sold at
this time because the number of shares sold depends on the number of our employees that participate
in the Offer, in what amounts the employees determine to invest, and the share price of our common
stock on the purchase date. We will update this prospectus supplement by filing an additional supplement
prior to the purchase of those shares of our common stock, which prospectus supplement will include
the number of shares to be purchased under the Offer.
Investing in our common stock involves a high degree of risk. Please see the section entitled
Risk Factors beginning on page S-3 of this prospectus supplement to read about risks you should
consider carefully before buying shares of our common stock.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus supplement or the
accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal
offense.
We are directly selling these shares and have not retained the services of a placement agent
in connection with the shares offered by this prospectus supplement and the accompanying
prospectus. Please see the section entitled Plan of Distribution in this prospectus supplement.
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Per Share |
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Maximum Offering |
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Public offering price |
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$ |
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$ |
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Proceeds, before expenses, to us |
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$ |
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We expect the total offering expenses to be approximately
$ for all sales pursuant
to the prospectus supplemented by this prospectus supplement. Because there is no minimum offering
amount required as a condition to closing this offering, the actual public offering amount and
proceeds to us, if any, are not presently determinable and may be substantially less than the
maximum amounts set forth above.
The
date of this prospectus supplement is
TABLE OF CONTENTS
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Prospectus Supplement |
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S-1 |
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S-2 |
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S-3 |
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S-23 |
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S-23 |
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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 information contained in this prospectus supplement, the accompanying
prospectus and the documents we incorporate by reference in the accompanying prospectus. We have
not authorized anyone to provide you with information that is different. You should not assume
that the information in this prospectus supplement or the accompanying prospectus is accurate as of
any date other than the date on the front of this prospectus supplement or the prospectus or that
any document that we incorporated by reference in the accompanying prospectus is accurate as of any
date other than its filing date. You should not consider this prospectus supplement or the
accompanying prospectus to be an offer or solicitation relating to the securities in any
jurisdiction in which such an offer or solicitation relating to the securities is not authorized.
Furthermore, you should not consider this prospectus supplement or the accompanying prospectus to
be an offer or solicitation relating to the securities if the person making the offer or
solicitation is not qualified to do so, or if it is unlawful for you to receive such an offer or
solicitation.
i
ABOUT THIS PROSPECTUS SUPPLEMENT
This summary highlights selected information about us and this offering. This information is
not complete and does not contain all the information you should consider before investing in our
common stock pursuant to this prospectus supplement and the accompanying prospectus. You should
carefully read this entire prospectus supplement and the accompanying prospectus, including Risk
Factors contained in this prospectus supplement and the financial statements and the other
information that we incorporated by reference in the accompanying prospectus, before making an
investment decision.
This prospectus supplement supplements the accompanying prospectus filed with our registration
statement on Form S-3 (registration file no. 333-150260) as part of a shelf registration process.
Under the shelf registration process, we may offer to sell debt securities, preferred stock,
common stock, warrants and units, from time to time in one or more offerings up to a total dollar
amount of $150,000,000.
This prospectus supplement describes the specific terms of this offering and the accompanying
prospectus gives more general information, some of which may not apply to this offering. If the
description of the offering varies between this prospectus supplement and the accompanying
prospectus, you should rely on the information contained in this prospectus supplement.
Unless the context otherwise requires, references to we, us or the Company in this
prospectus supplement and accompanying prospectus shall refer to Spectrum Pharmaceuticals, Inc.
Generally, when we refer to this prospectus we are referring to both this prospectus supplement
and the accompanying base prospectus combined.
ABOUT SPECTRUM PHARMACEUTICALS
Spectrum Pharmaceuticals, Inc. is a biopharmaceutical company that acquires, develops and
commercializes a diversified portfolio of oncology and other drug candidates that meet critical
health challenges for which there are few other treatment options. The Company has two marketed
products, Fusilev and Zevalin®. Zevalin® is currently marketed in the United States by RIT
(Radioimmunotherapeutics) Oncology, LLC, a wholly-owned subsidiary
of Spectrum. The
Companys pipeline includes promising early and late stage drug candidates with unique formulations
and mechanisms of action that address the needs of seriously ill patients, such as at-home
chemotherapy and new treatment regiments for refractory disease.
Spectrum Pharmaceuticals, Inc. is a Delaware corporation that was originally incorporated in
Colorado as Americus Funding Corporation in December 1987, became NeoTherapeutics, Inc. in August
1996, was reincorporated in Delaware in June 1997, and was renamed Spectrum Pharmaceuticals, Inc.
in December 2002. Our principal executive offices are located at 157 Technology Drive, Irvine,
California 92618, and our telephone number at that address is (949) 788-6700. Additional
information concerning the Company can be in our periodic filings with the SEC which are available
on our website at www.spectrumpharm.com and on the SECs website at www.sec.gov.
S-1
THE OFFERING
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Common stock offered by us:
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Common stock outstanding before the offering:
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32,166,316 |
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Common stock to be outstanding after the offering (if all shares are sold):
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Use of proceeds:
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We currently
anticipate that the
net proceeds from
the sale of the
common stock will
be used for general
corporate purposes.
Please see the
section entitled
Use of Proceeds |
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Nasdaq Global Market Symbol:
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SPPI |
The information above is based on 32,166,316 shares of our common stock outstanding as of
December 31, 2008. This number does not include:
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136,000 shares of common stock issuable upon the conversion of our Series E Preferred
Stock; |
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5,444,555 shares of common stock issuable upon the exercise of outstanding warrants to
purchase our common stock; |
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7,115,772 shares of common stock issuable upon the exercise of outstanding stock
options under our stock incentive plans, with a weighted average exercise price of
$4.80;
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approximately 1,000,000 shares of common stock available for future grants under our equity incentive
plans. |
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approximately 195,409 shares of common stock available for
issuance under our 401(k) profit-sharing plan. |
S-2
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 part or all of your investment. You should carefully consider the risks described below with
all of the other information included in this Prospectus Supplement, our Annual Report on Form 10-K
for the fiscal year ended December 31, 2007, our quarterly reports for the Quarters ended March 31,
2008, June 30, 2008 and September 30, 2008, and our other filings with the SEC. 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
We have a history of operating losses and our losses may 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 September 30, 2008 were in excess
of $245 million. Our net losses up to September 30, 2008 and full year 2007 were $6.8 million and $34 million,
respectively. We expect to continue to incur significant additional losses as we implement our
growth strategy of commercializing our approved drug products and developing our pipeline products
for at least the next several years. 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 sufficient cash 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 all our drug products, to commercialize our approved drug products and to
capitalize on growth opportunities. While we have been successful recently in generating funds
through the licensing and sale of our assets, we have historically relied primarily on raising
capital through the sale of our securities and out-licensing our drug products to meet our
financial needs. Although we began selling products in 2008, we believe that in the near-term we
will likely need to continue to raise funds in order to continue drug product development and
acquisition.
We may not be able to raise additional capital on favorable terms, if at all, particularly
with the current volatile financial market conditions. 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 and
commercialization activities. An inability to raise additional capital would also materially
impact our ability to expand operations.
Clinical trials may fail to demonstrate the safety and efficacy of our drug products, which could
prevent or significantly delay obtaining regulatory approval.
Prior to receiving approval to commercialize any of our drug products, we must demonstrate
with substantial evidence from well-controlled clinical trials, and to the satisfaction of the U.S.
Food and Drug Administration, or FDA, and other regulatory authorities in the United States and
other countries, that each of the products is both safe and effective. For each drug product, 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.
All of our drug products are prone to the risks of failure inherent in drug development.
Clinical trials of new drug products sufficient to obtain regulatory marketing approval are
expensive and take years to complete. We may not be able to successfully complete clinical testing
within the time frame we have planned, or at all. We may experience numerous unforeseen events
during, or as a result of, the clinical trial process that could delay or prevent
S-3
us from receiving regulatory approval or commercializing our drug products. In addition, the
results of pre-clinical studies and early-stage clinical trials of our drug products do not
necessarily predict the results of later-stage clinical trials. Later-stage clinical trials may
fail to demonstrate that a drug product is safe and effective despite having progressed through
initial clinical testing. Even if we believe the data collected from clinical trials of our drug
products is 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 products. Any failure or significant delay
in completing clinical trials for our drug products, or in receiving regulatory approval for the
sale of any drugs resulting from our drug products, may severely harm our business and reputation.
Even if we receive FDA and other regulatory approvals, our drug products 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 drug products from
the market.
If we are unable to effectively maintain and expand our sales and marketing capabilities, we may be
unable to successfully commercialize our approved products.
Historically, we have had limited internal experience in selling, marketing or distributing
pharmaceutical products. However, we have recently established a small direct sales force to
market our approved products. We also are expanding our direct sales
force in connection with the re-launch of Zevalin®. If we are not able to effectively hire and train qualified
individuals as part of our sales force, our product sales and resulting revenues will be negatively
impacted.
If we are unable to expand approved usage of Zevalin®, or to maintain or obtain improved
reimbursement rates for it, the products operating results may be harmed, which could adversely
affect our financial and operating results.
S-4
We intend to seek expansion of the approved uses
of Zevalin® in the United States. If we are unable to expand the approved uses of
Zevalin®, or if we are otherwise unable to fulfill our marketing, sales and distribution plans for
Zevalin®, we may not recognize the full anticipated value of our investment in the product and our
financial and operating results could be adversely affected.
In 2007, the Centers for Medicare and Medicaid Services, or CMS, implemented new outpatient
reimbursement rates for radiopharmaceuticals, including Zevalin®. The new reimbursement rates are
significantly below the institution or providers current acquisition cost for Zevalin®. Congress
has passed legislation to delay the implementation of those new rates and stabilize reimbursement
rates through January 1, 2010, with the intention of giving drug manufacturers and CMS time to
reach an agreement that more adequately reflects costs associated affected pharmaceuticals.
However, CMS may not agree to a rate or methodology that provides an
acceptable reimbursement on radiopharmaceuticals such as Zevalin®. In the event that CMS does not
agree to a reimbursement rate that is adequate to cover an institution or providers acquisition
cost for Zevalin®, we could face significant difficulty in getting care providers to use Zevalin®,
which would have an adverse impact on the products expected operating results, and in turn
adversely impact our investment in the product and our financial and operating results.
We may face difficulties in achieving broader market acceptance of Zevalin® if we do not
invest significantly in our sales and marketing infrastructure.
U.S.
sales of Zevalin® have declined over the several years prior to
our
acquisition of the Zevalin® assets. We believe that an enhanced sales and
marketing strategy for Zevalin®, in conjunction with efforts to obtain approval by the FDA for
expanded uses of Zevalin®, has significant potential to increase sales of and revenue from Zevalin®
over the next few years. However, implementation of the sales and marketing
strategy for Zevalin®, and the efforts to expand approved usage of Zevalin®, will require a
significant investment of financial and other resources by us for the foreseeable
future and may not ultimately increase Zevalin® sales or allow us to realize the anticipated
benefits from our investment in the product. Additionally, our efforts to establish an
effective direct sales force for Zevalin® will require significant commitments of both financial
and management resources by us, and may not ultimately be successful due a variety of
factors, including industry competition for effective sales and marketing personnel or the
inability of us to dedicate the necessary resources to those
efforts.
The
intellectual property and assets owned by our subsidiary, RIT, are subject to a security
agreement with Biogen that secures the entitys payment and other obligations to Biogen, and
we have guaranteed all of those obligations.
In
connection with the formation of RIT, RIT
entered into a security agreement with Biogen pursuant to which RIT granted to Biogen
a first priority security interest in all of its assets, which consist of the
Zevalin®-related intellectual property and other assets RIT.
The security agreement secures certain payment, indemnification and other obligations of RIT to Biogen related to Zevalin®. If RIT
were to default on certain of its
obligations to Biogen, or in certain other circumstances generally related to a bankruptcy or
insolvency of RIT, Biogen could seek to foreclose on the collateral under the
security agreement to obtain satisfaction of RITs obligations to it. If RIT were to default on its obligations to Biogen, and Biogen were to foreclose on the
collateral under the security agreement, RITs business could be materially and
adversely impacted, which could in turn materially and adversely impact our investment in RIT and our financial condition and results of operations.
Furthermore,
in connection with the formation of RIT we guaranteed all of RITs
obligations to Biogen. If RIT were to default on its obligations to Biogen, Biogen
could require us alone to satisfy all of those obligations under our guarantee.
S-5
The financial and other obligations that we would incur could have a
material and adverse effect on our financial condition and results of
operations.
If
we are unable to expand the approved usage of Fusilev, the
products operating results may be harmed, which could adversely
affect our financial and operating results.
We
have filed a supplemental new drug application for Fusilev for use in
combination with 5-FU-containing regimens in the treatment of
colorectal cancer. The greatest potential use of our product is in
this indication. If we are not able to obtain approval for this
indication, we may not recognize the full anticipated value of our
investment in the product and our financial and operating results
could be adversely affected.
Our drug product Fusilev may not be more cost efficient than competing drugs and otherwise may not
have any competitive advantage, which could hinder our ability to successfully commercialize it.
Fusilev is a novel folate analog formulation and the pharmacologically active isomer (the
levo-isomer) of the racemic compound calcium leucovorin, a product already approved for the same
indications our product is approved for. Leucovorin has been sold as a generic product on the
market for a number of years. There are generic companies currently selling the product. 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 have Fusilev manufactured in a cost efficient manner or at a cost below the
generic leucovorin cost price and we may not recognize the full anticipated value of our investment in the product. Also, Fusilev will be offered as part of a treatment regimen, and
that regimen may change to exclude Fusilev. Accordingly, it may not gain acceptance by the medical
field or become commercially successful.
The marketing and sale of Fusilev and Zevalin® may be adversely affected by the marketing and
sales efforts of third parties who sell these products outside the United States.
We have only licensed the
rights to develop, market and sell Fusilev in North America, and
have licensed the rights to develop, market and sell Zevalin® in the United
States. Other companies market and sell the same products in other parts of the world. If, as a
result of their actions, negative publicity is associated with the product, our own efforts to
successfully market and sell these products, may be adversely impacted.
The development of our drug product, EOquin®, may be adversely affected if the development efforts
of Allergan, who retained certain rights to the product, are not successful.
In 2008, we entered into a co-development and license agreement with Allergan, Inc., or
Allergan, for the worldwide development and commercialization of our drug product, EOquin®.
Allergan has agreed to partially fund development and commercialization expenses for EOquin®. We
do not fully control the drug development process under the license agreement. In addition, if we
do not achieve certain milestones under the license agreement and it has been determined that
failure to achieve these milestones was a result of our actions or inactions, Allergan is entitled
to assume additional control over the development process. As a result, success of this product
could depend, in part, upon the efforts of Allergan. Allergan may not be successful in the
clinical development of the drug, obtaining approval of the product by regulatory authorities, or
the eventual commercialization of EOquin®.
The development of our drug product, ozarelix, may be adversely affected if the development efforts
of Aeterna Zentaris, who retained certain rights to the product, are not successful.
Aeterna Zentaris licensed the rights to us to develop and market ozarelix in the United
States, Canada, Mexico and India. Aeterna Zentaris may conduct its own clinical trials on ozarelix
for regulatory approval in all other parts of the world. We will not have control over Aeterna
Zentaris development activities and our ability to attain regulatory approvals for ozarelix may be
adversely impacted if its efforts are not successful.
The development of our drug product, 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 AG, or GPC, for the worldwide
development and commercialization of our drug product, satraplatin. GPC 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 this product depends upon the efforts of GPC and
any of its sublicensees. GPC may not be successful in the clinical development of the drug,
obtaining approval of the product by regulatory authorities, or the eventual commercialization of
satraplatin.
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. Dr.
Shrotriya has been President since 2000 and Chief Executive Officer since 2002, and has spearheaded
our business strategy since that time. The loss of the services of Dr. Shrotriya or any other key
personnel could delay or preclude us from achieving our business objectives.
We also require expertise in sales, 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.
As we evolve from a company primarily involved in development to a company also involved in
commercialization, we may encounter difficulties in managing our growth and expanding our
operations successfully.
S-6
We only recently began commercial sales of our products and have had to increase our personnel
accordingly, including establishing a direct sales force. In addition, as we advance our drug
products through clinical trials, we will need to expand our development, regulatory,
manufacturing, marketing and sales capabilities or contract with third parties to provide these
capabilities for us. As our operations expand, we expect that we will need to manage additional
relationships with such third parties, as well as additional collaborators and suppliers.
Maintaining these relationships and managing our future growth will impose significant added
responsibilities on members of our management. We must be able to: manage our development efforts
effectively; manage our clinical trials effectively; hire, train and integrate additional
management, development, administrative and sales and marketing personnel; improve our managerial,
development, operational and finance systems and expand our facilities, all of which may impose a
strain on our administrative and operational infrastructure.
If we acquire additional businesses, we may not successfully integrate their operations.
We may acquire additional businesses that complement or augment our existing business. To
date, we have no experience in acquiring and integrating other businesses. Integrating any newly
acquired business could be expensive and time-consuming. We may not be able to integrate any
acquired business successfully or operate any acquired business profitably. Our future financial
performance will depend, in part, on our ability to manage any future growth effectively and our
ability to integrate any acquired businesses. We may not be able to accomplish these tasks, and
our failure to accomplish any of them could prevent us from successfully growing our company.
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, which could negatively impact our research and development
activities.
We may 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 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.
We are subject to risks associated with doing business internationally.
Since we conduct clinical trials and manufacture our drug products internationally, our
business is subject to certain risks inherent in international business, many of which are beyond
our control. These risks include, among other things:
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maintaining compliance with foreign legal requirements, including employment law; |
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unexpected changes in foreign regulatory requirements, including quality
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tariffs, customs, duties and other trade barriers; |
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changing economic conditions in countries where our products are manufactured; |
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exchange rate risks; |
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product liability, intellectual property and other claims; |
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political instability; |
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new export license requirements; and |
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difficulties in coordinating and managing foreign operations. |
Any of these factors could have an adverse effect on our business, financial condition and
results of operations. We may not be able to successfully manage these risks or avoid their
effects.
We may have conflicts with our partners that could delay or prevent the development or
commercialization of our drug products.
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 drug product, 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 that we believe are due to us under a collaboration; |
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uncertainty regarding ownership of intellectual property rights
arising from our collaborative activities, which could prevent us from
entering into additional collaborations; |
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unwillingness by the 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 disclosure of the results of those activities; |
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initiation of litigation or alternative dispute resolution options by
either party to resolve the dispute; or |
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attempts by either party to terminate the collaboration. |
Our efforts to acquire or in-license and develop additional drug products may fail, which might
limit our ability to grow our business.
Our long-term strategy includes the acquisition or in-license of additional drug products. We
are actively seeking to acquire, or in-license, additional commercial drug products as well as drug
products that have demonstrated positive pre-clinical and/or clinical data. We have certain
criteria that we are looking for in any drug product acquisition and we may not be successful in
locating and acquiring, or in-licensing, additional desirable drug products 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 drug products in late-stage
clinical development. Many of the companies and institutions that compete against us have
substantially greater capital resources, research and
S-8
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 portfolio through the in-license or acquisition of compounds. Moreover, while it is not
feasible to predict the actual cost of acquiring additional drug products, that cost could be
substantial and we may need to raise additional financing, which may further dilute existing
stockholders, in order to acquire new drug products.
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.
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 drug products that directly compete with the drugs
that we sell or that 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 the treatment of disease, advanced drug delivery and specific clinical benefits over
competitive drug therapies. We may not be successful in any or all of our current clinical studies;
or if successful, and if one or more of our drug products 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 products. Companies that have products on the market or in research and
development that target the same indications as our products target include Ardana Bioscience,
Neurocrine Biosciences, Abraxis Bioscience, Inc., Astra Zeneca LP, Amgen, Inc., Bayer AG, Bioniche
Life Sciences Inc., Eli Lilly and Co., Novartis Pharmaceuticals Corporation, Ferring
Pharmaceuticals, NeoRx Corporation, Genentech, Inc., Bristol-Myers Squibb Company, GlaxoSmithKline,
Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-aventis, Inc.,
Pfizer, Inc., AVI Biopharma, Inc., Genta Inc., Genzyme Corporation, Imclone Systems Incorporated,
Millennium Pharmaceuticals, Shire Pharmaceuticals, TAP Pharmaceuticals, Inc., QLT Inc., Abbott
Laboratories, Poniard Pharmaceuticals, Inc., Roche Pharmaceuticals, Schering-Plough, Johnson &
Johnson and others who may be more advanced in the development of competing drug products or are
more established. 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 supply of drug products will be dependent upon the production capabilities of contract
manufacturing organizations, or CMOs, and component and packaging supply sources, and, if such CMOs
are not able to meet our demands, we may be limited in our ability to meet demand for our products,
ensure regulatory compliance or maximize profit on the sale of our products.
We have no internal manufacturing capacity for our drug products, and, therefore, we have
entered into agreements with CMOs to supply us with active pharmaceutical ingredients and our
finished dose 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
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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 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 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 Practice, or cGMP, requirements, the possible breach of the
manufacturing agreement by the CMO 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 drug products, 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. In addition, our CMOs will be subject to on-going periodic inspection by the
FDA and corresponding state and foreign agencies for compliance with cGMP regulations, similar
foreign regulations and other regulatory standards. We do not have control over our CMOs
compliance with these regulations and standards. 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 them or us, including warning letters,
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
APIs or manufacturing of finished 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 APIs and finished dose 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
could be harmed.
We rely on contract suppliers to supply our existing products, and will likely do the same for
other products that we may develop, commercialize or acquire in the future. Contract suppliers may
not be able to meet our needs with respect to timing, cost, quantity or quality. All of our
suppliers are sole-source suppliers and no currently qualified alternative suppliers exist.
If we are unable to contract for a sufficient supply of our required products and services on
acceptable terms, or if we should encounter delays or difficulties in our relationships with our
manufacturers, or if any required approvals by the FDA and other regulatory authorities do not
occur on a timely basis, we will lose sales. Moreover, contract suppliers that we may use must
continually adhere to current good manufacturing practices enforced by the FDA. If the facilities
of these suppliers cannot pass an inspection, we may lose FDA approval of our products. Failure to
obtain products for sale for any reason may result in an inability to meet product demand and a
loss of potential revenues.
Our drug products may not be more effective, safer or more cost-efficient than a competing drug and
otherwise may not have any competitive advantage, which could hinder our ability to successfully
commercialize our drug products.
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Any drug 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 development products ultimately receives FDA
approval, our drug products 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 development products, they may not gain acceptance by the medical field or become
commercially successful.
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 products will be observed in broader patient populations, and the number of
patients who may benefit from our drug products may be significantly smaller than the estimated
patient populations.
Risks Related to Our Industry
If third-party payors do not adequately reimburse providers for any of our product candidates, if
approved for marketing, we may not be successful in selling them.
Our ability to commercialize any products successfully will depend in part on the extent to
which reimbursement will be available from governmental and other third-party payors, both in the
United States and in foreign markets. Even if we succeed in bringing one or more products to the
market, the amount reimbursed for our products may be insufficient to allow us to compete
effectively and could adversely affect our profitability.
Reimbursement by a governmental and other third-party payors may depend upon a number of
factors, including a governmental or other third-party payors determination that use of a product
is:
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a covered benefit under its health plan; |
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safe, effective and medically necessary; |
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appropriate for the specific patient; |
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cost-effective; and |
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neither experimental nor investigational. |
Obtaining reimbursement approval for a product from each third-party and governmental payor is
a time-consuming and costly process that could require us to provide supporting scientific,
clinical and cost-effectiveness data for the use of our products to each payor. We may not be able
to provide data sufficient to obtain reimbursement.
Eligibility for coverage does not imply that any drug product will be reimbursed in all cases
or at a rate that allows us to make a profit. Interim payments for new products, if applicable, may
also not be sufficient to cover our costs and may not become permanent. Reimbursement rates may
vary according to the use of the drug and the clinical setting in which it is used, may be based on
payments allowed for lower-cost drugs that are already reimbursed, may be incorporated into
existing payments for other products or services, and may reflect budgetary constraints and/or
Medicare or Medicaid data used to calculate these rates. Net prices for products also may be
reduced by mandatory discounts or rebates required by government health care programs or by any
future relaxation of laws that restrict imports of certain medical products from countries where
they may be sold at lower prices than in the United States.
Rapid bio-technological advancement may render our drug products 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 products and thereby
cause our drug products to become commercially obsolete. Some of our drug products 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 products 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 drug products.
Before our drug products 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 drug products satisfy rigorous
standards of safety and efficacy. We need to conduct significant research, pre-clinical testing and
clinical testing, before we can file applications with the FDA for approval of our drug products.
The process of obtaining FDA and other regulatory approvals is time-consuming,
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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 product is not sufficiently safe
or effective in treating the targeted disease.
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
products.
Failure to obtain regulatory approval outside the United States will prevent us from marketing our
product candidates abroad.
We intend to market certain of our existing and future product candidates in non-U.S. markets.
In order to market our existing and future product candidates in the European Union and many other
non-U.S. jurisdictions, we must obtain separate regulatory approvals. We have had limited
interactions with non-U.S. regulatory authorities, and the approval procedures vary among countries
and can involve additional testing, and the time required to obtain approval may differ from that
required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory
authorities in other countries, and approval by one or more non-U.S. regulatory authorities does
not ensure approval by regulatory authorities in other countries or by the FDA. The non-U.S.
regulatory approval process may include all of the risks associated with obtaining FDA approval as
well as other risks specific to the jurisdictions in which we may seek approval. We may not obtain
non-U.S. regulatory approvals on a timely basis, if at all. We may not be able to file for non-U.S.
regulatory approvals and may not receive necessary approvals to commercialize our existing and
future product candidates in any market.
Even after we receive regulatory approval to market our drug products, the market may not be
receptive to our drug products upon their commercial introduction, which would negatively affect
our ability to achieve profitability.
Our drug products may not gain market acceptance among physicians, patients, healthcare payors
and the medical community. The degree of market acceptance of any approved drug products will
depend on a number of factors, including:
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the effectiveness of the drug product; |
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the prevalence and severity of any side effects; |
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potential advantages or disadvantages over alternative treatments; |
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relative convenience and ease of administration; |
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the strength of marketing and distribution support; |
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the price of the drug product, both in absolute terms and relative to
alternative treatments; and |
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sufficient third-party coverage or reimbursement. |
If our drug products receive regulatory approval but do not achieve an adequate level of
acceptance by physicians, healthcare payors and patients, we may not generate drug product revenues
sufficient to attain profitability.
Our failure to comply with governmental regulations may delay or prevent approval of our drug
products 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
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consuming compliance procedures. While we believe that we are currently in compliance with
applicable FDA regulations, if our partners, our CROs, our CMOs 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 drug product 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 product 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 drug products, 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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warning letters; |
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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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delays, 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. |
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 drug product, including withdrawal from the market. In addition, the FDA may
revisit and change its prior determinations with regard to the safety and efficacy of our 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 products if concerns
about their safety or effectiveness develop.
Our failure to comply with FDA (and related) regulations applicable to our business may subject us
to sanctions, which could damage our reputation and adversely affect our business condition.
In the U.S., the FDA, and comparable state regulatory agencies and enforcement authorities,
impose requirements on us as a manufacturer and marketer of prescription drug products. Drug
manufacturers are required to register with FDA, and are required to comply with various regulatory
requirements regarding drug research, manufacturing, distribution, reporting and recordkeeping.
Most drug products must be approved by the FDA prior to marketing, and companies are required to
comply with numerous post-marketing requirements. Companies are also subject to periodic
inspection by the FDA for compliance with cGMP and other applicable regulations.
Further, drug manufacturers are required to comply with FDA requirements for labeling and
advertising, as well as other Federal and state requirements for advertising. This includes a
prohibition on promotion for
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unapproved or off-label uses, e.g., promotion of products for uses that are not described in
the products FDA-approved labeling. While a physician may prescribe a medication for off-label
uses where appropriate, companies may not generally promote drug products for off-label uses.
If FDA or other Federal and state agencies believe that a company is not in compliance with
applicable regulations, they have various enforcement authorities to address violations. FDA can
issue a warning letter and seek voluntary compliance from a company in the form of remedial or
corrective action. FDA may also impose civil money penalties by administrative action, and through
judicial enforcement seek actions including injunctions, seizures, and criminal penalties. FDA or
other Federal and state authorities may also seek operating restrictions on a company in order to
achieve compliance, including termination or suspension of company activities. Such agencies and
enforcement authorities may also disseminate information to the public about their enforcement
actions.
If we were to become subject to any FDA or similar enforcement action related to any of our
drug products, our business condition could be adversely affected, and the public release of such
information could be damaging to our reputation.
Legislative or regulatory reform of the healthcare system and pharmaceutical industry related to
pricing or reimbursement 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 payors
such as government health administration authorities, private health insurers, health maintenance
organizations including pharmacy benefit managers and other health care-related organizations. Both
the Federal and state governments in the U.S. and foreign governments continue to propose and pass
new legislation and regulations designed to contain or reduce the cost of health care. Such
legislation and regulations 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.
It is possible that proposals will be adopted, or existing regulations that affect the
coverage or pricing of pharmaceutical and other medical products may 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 payors 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.
In some foreign countries, particularly in the European Union, prescription drug pricing is
subject to governmental control. In these countries, pricing negotiations with governmental
authorities can take considerable time after the receipt of marketing approval for a product. To
obtain reimbursement or pricing approval in some countries, we may be required to conduct a
clinical trial that compares the cost-effectiveness of our product candidate to other available
therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if
pricing is set at unsatisfactory levels, our profitability will be negatively affected.
If we market products in a manner that violates health care anti-kickback or other fraud and abuse
laws, we may be subject to civil or criminal penalties, including exclusions from participation in
Federal health care programs.
The Federal health care program anti-kickback statute prohibits, among other things, knowingly
and willfully offering, paying, soliciting, or receiving remuneration to induce or in return for
purchasing, leasing, ordering, or arranging for the purchase, lease or order of any health care
item or service reimbursable under Medicare, Medicaid or other federally financed health care
programs. This statute applies to arrangements between pharmaceutical manufacturers and
prescribers, purchasers and formulary managers. Although there are a number of statutory exemptions
and regulatory safe harbors protecting certain common activities, the exemptions and safe harbors
are drawn narrowly, and practices that involve remuneration intended to induce prescribing,
purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or
safe harbor.
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Federal false claims laws prohibit any person from knowingly presenting, or causing to be
presented, a false claim for payment to the Federal government, or knowingly making, or causing to
be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted
under these laws for a variety of alleged promotional and marketing activities, such as providing
free product to customers with the expectation that the customers would bill Federal programs for
the product; reporting to pricing services inflated average wholesale prices that were then used by
Federal programs to set reimbursement rates; engaging in off-label promotion that caused claims to
be submitted to Medicaid for non-covered off-label uses; and submitting inflated best price
information to the Medicaid Rebate Program.
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 also created
prohibitions against health care fraud and false statements relating to health care matters. The
health care fraud statute prohibits knowingly and willfully executing a scheme to defraud any
health care benefit program, including private payors. The false statements statute prohibits
knowingly and willfully falsifying, concealing or covering up a material fact or making any
materially false, fictitious or fraudulent statement in connection with the delivery of or payment
for health care benefits, items or services.
The majority of states also have statutes or regulations similar to these Federal laws, which
apply to items and services reimbursed under Medicaid and other state programs, or, in several
states, apply regardless of the payor. In addition, some states have laws that require
pharmaceutical companies to adopt comprehensive compliance programs. For example, under California
law, pharmaceutical companies must comply with both the April 2003 Office of Inspector General
Compliance Program Guidance for Pharmaceutical Manufacturers and the PhRMA Code on Interactions
with Healthcare Professionals, as amended. We have adopted and implemented a compliance program
which we believe satisfies the applicable requirements of California law.
Sanctions under these Federal and state laws may include civil monetary penalties, exclusion
of a manufacturers products from reimbursement under government programs, criminal fines and
imprisonment. Because of the breadth of these laws and the narrowness of the safe harbors, it is
possible that some of our business activities could be subject to challenge under one or more of
such laws. If our past, present or future operations are found to be in violation of any of the
laws described above or other similar governmental regulations to which we are subject, we may be
subject to the applicable penalty associated with the violation which could adversely affect our
ability to operate our business and our financial results.
If we are unable to adequately protect our technology or enforce our patent rights, our business
could suffer.
Our success with the drug products that we develop will depend, in part, on our ability and
the ability of our licensors 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. Our license agreements generally give us the
right and/or obligation to maintain and enforce the subject patents. We may not 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 allowed or, if allowed and issued into patents, if
such patents and the patents we have licensed are not upheld in a court of law, our ability to
competitively exploit our drug 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.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
involve complex legal and factual questions. No consistent policy regarding the breadth of claims
allowed in biotechnology patents has emerged to date in the United States. The laws of many
countries may not protect intellectual property rights to the same extent as United States laws,
and those countries may lack adequate rules and procedures for defending our intellectual property
rights. Filing, prosecuting and defending patents on all our products or product candidates
throughout the world would be prohibitively expensive. Competitors may use our technologies in
jurisdictions and may not be covered by any of our patent claims or other intellectual property
rights.
Changes in either patent laws or in interpretations of patent laws in the United States and
other countries may diminish the value of our intellectual property. We do not know whether any of
our patent applications will
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result in the issuance of any patents, and we cannot predict the breadth of claims that may be
allowed in our patent applications or in the patent applications we license from others.
The degree of future protection for our proprietary rights is uncertain because legal means
afford only limited protection and may not adequately protect our rights or permit us to gain or
keep our competitive advantage. For example:
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we or our licensors might not have been the first to make the inventions covered by each of our or
our licensors pending patent applications and issued patents, and we may have to participate in
expensive and protracted interference proceedings to determine priority of invention; |
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we or our licensors might not have been the first to file patent applications for these inventions; |
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others may independently develop similar or alternative product candidates or duplicate any of our
or our licensors product candidates; |
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our or our licensors pending patent applications may not result in issued patents; |
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our or our licensors issued patents may not provide a basis for commercially viable products or
may not provide us with any competitive advantages or may be challenged by third parties; |
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others may design around our or our licensors patent claims to produce competitive products that
fall outside the scope of our or our licensors patents; |
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we may not develop or in-license additional patentable proprietary technologies related to our
product candidates; or |
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the patents of others may prevent us from marketing one or more of our product candidates for one
or more indications that may be valuable to our business strategy. |
Moreover, an issued patent does not guarantee us the right to practice the patented technology
or commercialize the patented product. Third parties may have blocking patents that could be used
to prevent us from commercializing our patented products and practicing our patented technology.
Our issued patents and those that may be issued in the future may be challenged, invalidated or
circumvented, which could limit our ability to prevent competitors from marketing related product
candidates or could limit the length of the term of patent protection of our product candidates. In
addition, our competitors may independently develop similar technologies. Moreover, because of the
extensive time required for development, testing and regulatory review of a potential product, it
is possible that, before any of our product candidates can be commercialized, any related patent
may expire or remain in force for only a short period following commercialization, thereby reducing
any advantage of the patent.
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 confidentiality 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 drug products are inherently uncertain and involve complex
legal and factual issues. Although we are not aware of any infringement by any of our drug products
on the rights of any third
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party, there may be third party patents or other intellectual property rights relevant to our
drug products of which we are not aware. Third parties may assert patent or other intellectual
property infringement claims against us with 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 their 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 we infringe 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
products.
We may be subject to damages resulting from claims that we, or our employees, have wrongfully used
or disclosed alleged trade secrets of our employees former employers.
Many of our employees were previously employed at universities or biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although we have not
received any claim to date, we may be subject to claims that these employees through their
employment inadvertently or otherwise used or disclosed trade secrets or other proprietary
information of their former employers. Litigation may be necessary to defend against these claims.
If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable
intellectual property rights or personnel.
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 United States and certain other countries 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 that such
additional insurance would be sufficient 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.
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.
S-18
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;
however, future claims may exceed the amount of our coverage. Also, we do not have insurance
coverage for pollution clean up and removal. Currently the costs of complying with federal, state
and local regulations are not significant, and consist primarily of waste disposal expenses.
Risks Related to this Offering and Our Common 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 December 30, 2008, there were approximately 32 million shares of our common stock
outstanding, and in addition, security holders held options, warrants and preferred stock which, if
vested, exercised or converted, would obligate us to issue up to approximately 12.7 million
additional shares of common stock. 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. In addition, we have a shelf registration
statement to sell up to $150 million of our securities, some or all of which may be shares of our
common stock or securities convertible into or exercisable for shares of our common stock, and all
of which would be available for resale in the market. The market price of our common stock could
fall as a result of sales of any of these shares of common stock due to the increased number of
shares available for sale in the market.
We have primarily financed our operations, and we anticipate that we will have to finance a
large portion of our operating cash requirements, 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 or other dilutive issuances would
also cause our net income, if any, per share to decrease in future periods. As a result, the market
price of our common stock could drop.
The market price and trading 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 trading volume
fluctuations that are unrelated to the operating performance of particular companies. These broad
market fluctuations may cause the market price and trading volume of our common stock to decrease.
In addition, the market price and trading volume of our common stock is often highly volatile.
Factors that may cause the market price and volume of our common stock to decrease include:
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adverse results or delays in our clinical trials; |
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fluctuations in our results of operations, timing and announcements of our
bio-technological innovations or new products or those of our competitors; |
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developments concerning any strategic alliances or acquisitions we may enter into; |
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announcements of FDA non-approval of our drug products, or delays in the FDA or
other foreign regulatory review process or actions; |
S-19
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adverse actions taken by regulatory agencies with respect to our drug products,
clinical trials, manufacturing processes or sales and marketing activities; |
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any lawsuit involving us or our drug products; |
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developments with respect to our patents and proprietary rights; |
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announcements of technological innovations or new products by our competitors; |
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public concern as to the safety of products developed by us or others; |
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regulatory developments in the United States and in foreign countries; |
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changes in stock market analyst recommendations regarding our common stock or
lack of analyst coverage; |
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the pharmaceutical industry generally and general market conditions; |
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failure of our results of operations to meet the expectations of stock market
analysts and investors; |
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sales of our common stock by our executive officers, directors and five percent
stockholders or sales of substantial amounts of our common stock; |
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changes in accounting principles; and |
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loss of any of our key scientific or management personnel. |
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. During 2008, the price of our common stock ranged
between $0.55 and
$3.35, and the daily trading volume was as high as
4,369,800
shares and as low as 20,200
shares. In addition, due in large part to the current global economic crisis many institutional
investors that historically had invested in specialty pharmaceutical companies have ceased
operations or further investment in these companies, which has had negatively impacted trading
volume for our stock.
Following periods of volatility in the market price of a companys securities, securities
class action litigation may be instituted against that company. Regardless of their merit, these
types of lawsuits generally result in substantial legal fees and managements attention and
resources being diverted from the operations of a business.
Provisions of our charter, 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 |
S-20
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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.
Our publicly-filed SEC reports are reviewed by the SEC from time to time and any significant
changes required as a result of any such review may result in material liability to us and have a
material adverse impact on the trading price of our common stock.
The reports of publicly-traded companies are subject to review by the Securities and Exchange
Commission, or the SEC, from time to time for the purpose of assisting companies in complying with
applicable disclosure requirements and to enhance the overall effectiveness of companies public
filings, and reviews of such reports are now required at least every three years under the
Sarbanes-Oxley Act of 2002. SEC reviews may be initiated at any time. While we believe that our
previously filed SEC reports comply, and we intend that all future reports will comply, in all
material respects with the published rules and regulations of the SEC, we could be required to
modify or reformulate information contained in prior filings as a result of an SEC review. Any
modification or reformulation of information contained in such reports could be significant and
could result in material liability to us and have a material adverse impact on the trading price of
our common stock.
Since we have broad discretion in how we use the proceeds from this offering, we may use the
proceeds in ways in which you disagree.
We have not allocated specific amounts of the net proceeds from this offering for any specific
purpose. Accordingly, our management will have significant flexibility in applying the net proceeds
of this offering. Accordingly, you will be relying on the judgment of our management with regard to
the use of these net proceeds, and you will not have the opportunity, as part of your investment
decision, to assess whether the proceeds are being used appropriately. It is possible that the net
proceeds will be invested in a way that does not yield a favorable, or any, return for our company.
The failure of our management to use such funds effectively could have a material adverse effect
on our business, financial condition, operating results and cash flow.
Investors in this offering may pay a higher price than the book value of our stock.
If you purchase common stock in this offering, you will incur an immediate and substantial
dilution in net tangible book value, after giving effect to the sale by us of shares of
common stock offered in this offering at the price to public of $ per share.
Due to the current condition of the financial markets, our financial assets could be compromised,
and we may be unable to raise additional capital in a timely manner.
We believe the financial institutions through which we have invested our funds are strong,
well capitalized and our instruments are held in accounts segregated from the assets of the
institutions. However, due to the current extremely volatile financial and credit markets and
liquidity crunch faced by most banking institutions, the financial viability of these institutions,
and the safety and liquidity of our funds is being constantly monitored. Should these
S-21
financial institutions fail to provide us with required liquidity at the time of need, we may
be adversely affected and may not be able to carry out our business plans as anticipated.
However, in light of the current volatile and tight financial and credit markets, 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 could also impact our ability to expand operations.
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 foreseeable future. Our current policy is to retain all
funds and any earnings for use in the operation and expansion of our business.
S-22
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the documents incorporated by reference into this prospectus
supplement contain forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Words such as anticipates, expects, intends, plans,
believes, seeks, estimates, and variations of such words and similar expressions are intended
to identify such forward-looking statements. These statements are based on current expectations,
estimates and projections about our industry, managements beliefs, and assumptions made by
management. These statements are not guarantees of future performance and are subject to certain
risks, uncertainties and assumptions that are difficult to predict; therefore, actual results may
differ materially from those expressed or forecasted in any forward-looking statements. The risks
and uncertainties include those noted in our SEC filings or any applicable prospectus supplement.
We urge you to consider these factors carefully in evaluating the forward-looking statements
contained in this prospectus supplement. All subsequent written or oral forward-looking statements
attributable to our company or persons acting on our behalf are expressly qualified in their
entirety by these cautionary statements. The forward-looking statements included in this
prospectus supplement are made only as of the date of this prospectus. We undertake no obligation
to update publicly any forward-looking statements, whether as a result of new information, future
events or otherwise, except to the extent that we are required to do so by law.
You should not place undue reliance on our forward-looking statements because the matters they
describe are subject to known and unknown risks, uncertainties and other unpredictable factors,
many of which are beyond our control. Our forward-looking statements are based on the information
currently available to us and speak only as of the date on the cover of this prospectus supplement
or, in the case of forward-looking statements incorporated by reference, as of the date of the
filing that includes the statement. New risks and uncertainties arise from time to time, and it is
impossible for us to predict these matters or how they may affect us. Over time, our actual
results, performance or achievements will likely differ from the anticipated results, performance
or achievements that are expressed or implied by our forward-looking statements, and such
difference might be significant and materially adverse to our security holders.
We have identified some of the important factors that could cause future events to differ from
our current expectations and they are described in this prospectus supplement under the caption
Risk Factors as well as in our most recent Annual Report on Form 10-K, including, without
limitation, under the captions Risk Factors and Managements Discussion and Analysis of
Financial Condition and Results of Operations and in other documents that we may file with the
SEC, all of which you should review carefully. Please consider our forward-looking statements in
light of those risks as you read this prospectus supplement and the accompanying prospectus.
USE OF PROCEEDS
We expect the net proceeds from this offering to be up to approximately $ after
deducting our estimated offering expenses, as described in Plan of Distribution. The net proceeds
from the sale of the shares offered hereby will be used for general corporate purposes, including,
without limitation, sales and marketing activities, clinical development, making acquisitions of
assets, businesses or securities, capital expenditures and for working capital. Pending the
application of the net proceeds, we may invest the proceeds in short-term, interest-bearing
instruments or other securities.
S-23
DILUTION
Our net tangible book value on September 30, 2008 was approximately $46.3 million, or
approximately $1.46 per share of common stock. Net tangible book value per share is determined by
dividing our net tangible book value, which consists of tangible assets less total liabilities, by
the number of shares of common stock outstanding on that date. Without taking into account any
other changes in our net tangible book value after September 30, 2008, other than to give effect to
our receipt of the estimated proceeds from the sale of the maximum number of shares issuable in
this offering ( shares) at an offering price of $ per share, less our estimated
offering expenses, our net tangible book value as of September 30, 2008 , after giving effect to
the items above, would have been approximately $ million, or $ per share. This
represents an immediate increase in the net tangible book value of $ per share to existing
stockholders and an immediate dilution of $ per share to new investors. The following table
illustrates this per share dilution:
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Public offering price per share |
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$ |
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Net tangible book value per share as of September 30, 2008 |
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1.46 |
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Increase in net tangible book value per share attributable to this offering |
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Pro forma
net tangible book value per share as of September 30, 2008, after giving effect to the offering |
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$ |
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Dilution per share to new investors in the offering |
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$ |
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The
above table is based on 32,166,316 shares of our common stock outstanding as of
December 31, 2008 (as adjusted for shares to be issued in this offering) and excludes, as
of December 31, 2008:
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136,000 shares of common stock issuable upon the conversion of our Series E Preferred
Stock; |
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5,444,555 shares of common stock issuable upon the exercise of outstanding warrants to
purchase our common stock; |
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7,115,772 shares of common stock issuable upon the exercise of outstanding stock
options under our stock incentive plans, with a weighted average exercise price of $4.80;
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approximately 1,000,000 shares of common stock available for future grants under our equity incentive
plans. |
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approximately 195,409 shares of common stock available for
issuance under our 401(k) profit-sharing plan. |
To the extent that any of these options or warrants are exercised, new options are issued
under our stock incentive plans, additional shares of common stock are issued under our employee
stock purchase plan or we otherwise issue additional shares of common stock in the future, there
will be further dilution to new investors.
S-24
PLAN OF DISTRIBUTION
We are offering the shares of common stock directly from us, without the use of a placement
agent, to certain of our employees who tender their eligible options as part of our offer to
purchase certain of our outstanding stock options, announced on March 23, 2009 and who elect to
purchase shares of our common stock with the net cash proceeds from tendering their options. The
purchase price of the shares sold hereunder will be the closing trading price of our common stock
as quoted on the NASDAQ Global Market on the third business day following the expiration of the
offer described above.
Our obligation to issue and sell shares to the purchasers will be subject to the terms and
conditions of a purchase agreement entered into with each purchaser. If all eligible employees
elected to purchase shares of our common stock as part of the offer described above, we estimate
that we would issue up to
shares
based on the closing price of our common stock on
. We anticipate that the sale of the shares will
be completed on April 20, 2009. We
estimate the total expenses of this offering which will be payable by us, will be approximately
$ .
LEGAL MATTERS
The validity of the common stock being offered hereby will be passed on by Stradling Yocca
Carlson & Rauth, a Professional Corporation, Newport Beach, California.
EXPERTS
The consolidated financial statements and managements assessment of the effectiveness of
internal control over financial reporting (which is included in Managements Report on Internal
Control Over Financial Reporting) incorporated in this prospectus supplement by reference to the
Annual Report on Form 10-K for the year ended December 31, 2007 have been so incorporated in
reliance on the report of Kelly and Company, an independent registered public accounting firm,
given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus supplement and accompanying prospectus is part of a registration statement on
Form S-3 that we filed with the SEC registering the securities that may be offered and sold
hereunder. The registration statement, including exhibits thereto, contains additional relevant
information about us and these securities that, as permitted by the rules and regulations of the
SEC, we have not included in this prospectus. A copy of the registration statement can be obtained
at the address set forth below. You should read the registration statement for further information
about us and these securities.
We file annual, quarterly and special reports, proxy statements and other information with the
SEC under the Securities Exchange Act of 1934, as amended, or the Exchange Act. You may read and
copy this information at the following SEC location:
Public Reference Room
100 F Street, N.E.
Washington, D.C. 20549
You may obtain information on the operation of the Public Reference Room by calling the SEC at
(800) SEC-0330. The SEC also maintains a web site that contains reports, proxy statements,
information statements and other information about issuers, like Spectrum Pharmaceuticals, Inc.,
who file electronically with the SEC. The address of that web site is www.sec.gov.
In addition, our common stock is listed on the NASDAQ Global Market and similar information
concerning us can be inspected and copied at the offices of The NASDAQ Stock Market, LLC, One
Liberty Plaza, 165 Broadway, New York, NY 10006.
S-25
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference information into this prospectus supplement.
This means that we can disclose important information about us and our financial condition to you
by referring you to another document filed separately with the SEC. The information incorporated by
reference is considered to be part of this prospectus supplement. This prospectus supplement
incorporates by reference the documents listed below that we have previously filed with the SEC:
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2007, filed with
the SEC on March 14, 2008; |
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our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2008, filed
with the SEC on May 12, 2008; June 30, 2008, filed with the SEC on August 11, 2008; and
September 30, 2008, filed with the SEC on November 7, 2008; |
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our Current Reports on Form 8-K (in each case, other than information and exhibits
furnished to and not filed with the SEC in accordance with SEC rules and regulations,
except as indicated) filed with the SEC on March 11, 2008, March 27, 2008, April 30, 2008,
2008, June 26, 2008, October 29, 2008, December 3, 2008, December 5, 2008, December 11,
2008 and December 19, 2008; and |
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the description of our Common Stock contained in the Registration Statement filed with
the SEC on Form 8-A, as filed on December 26, 2000, together with any amendments or reports
filed for the purposes of updating such description. |
We also incorporate by reference all documents that we file with the SEC after the date of
this prospectus supplement pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act and
prior to the sale of all securities registered hereunder or termination of the registration
statement. Nothing in this prospectus shall be deemed to incorporate information furnished but not
filed with the SEC.
Any statement contained in this prospectus supplement or in a document incorporated or deemed
to be incorporated by reference in this prospectus supplement shall be deemed to be modified or
superseded for purposes of this prospectus supplement to the extent that a statement contained
herein or in the applicable prospectus supplement or in any other subsequently filed document which
also is or is deemed to be incorporated by reference modifies or supersedes the statement. Any
statement so modified or superseded shall not be deemed, except as so modified or superseded, to
constitute a part of this prospectus supplement.
You may request a copy of the filings incorporated herein by reference, including exhibits to
such documents that are specifically incorporated by reference, at no cost, by writing or calling
us at the following address or telephone number:
William N. Pedranti, Esq.
Vice President, General Counsel
Spectrum Pharmaceuticals, Inc.
157 Technology Drive
Irvine, California 92618
Telephone: (949) 788-6700
Statements contained in this prospectus supplement as to the contents of any contract or other
documents are not necessarily complete, and in each instance investors are referred to the copy of
the contract or other document filed as an exhibit to the registration statement, each such
statement being qualified in all respects by such reference and the exhibits and schedules thereto.
S-26
PROSPECTUS
SPECTRUM PHARMACEUTICALS, INC.
$150,000,000
Debt Securities
Preferred Stock
Common Stock
Warrants
Units
This prospectus provides a general description of the following securities that may be offered
hereunder from time to time: Spectrum Pharmaceuticals, Inc.s debt securities, preferred stock,
common stock, warrants and units. The aggregate initial offering price of all securities sold under
this prospectus will not exceed $150,000,000. Each time we sell securities hereunder, we will
provide a supplement to this prospectus that contains specific information about the offering and
the specific terms of the securities offered. You should read this prospectus and the applicable
prospectus supplement carefully before you invest in our securities.
The common stock of Spectrum Pharmaceuticals, Inc. is listed on the Nasdaq Global Market under
the symbol SPPI.
Investing in our securities involves a high degree of risk. See Risk Factors contained in
our filings made with the Securities and Exchange Commission and the applicable prospectus
supplement.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is May 5, 2008.
TABLE OF CONTENTS
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Unless otherwise indicated or the context otherwise requires, the terms Company, Spectrum
Pharmaceuticals, we, us and our refer to Spectrum Pharmaceuticals, Inc., a Delaware
corporation, and its predecessors and consolidated subsidiaries.
If you are in a jurisdiction where offers to sell, or solicitations of offers to purchase, the
securities offered by this document are unlawful, or if you are a person to whom it is unlawful to
direct these types of activities, then the offer presented in this prospectus does not extend to
you.
We have not authorized anyone to give any information or make any representation about us that
is different from, or in addition to that contained in this prospectus, including in any of the
materials that we have incorporated by reference into this prospectus, any accompanying prospectus
supplement, and any free writing prospectus prepared or authorized by us. Therefore, if anyone does
give you information of this sort, you should not rely on it as authorized by us. Neither the
delivery of this prospectus, nor any sale made hereunder, shall under any circumstances create any
implication that there has been no change in our affairs since the date hereof or that the
information incorporated by reference herein is correct as of any time subsequent to the date of
such information.
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, using a shelf registration process. Under this shelf registration
statement, we may, from time to time, offer any combination of the securities described in this
prospectus in one or more offerings. The aggregate initial offering price of all securities sold
under this prospectus will not exceed $150,000,000.
The types of securities that we may offer and sell from time to time by this prospectus are:
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preferred stock; |
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common stock; |
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warrants; and |
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units, comprised of two or more of the following securities in any
combination: debt securities, preferred stock, common stock and
warrants. |
We may issue debt securities convertible into shares of Spectrum Pharmaceuticals, Inc. common
or preferred stock. The preferred stock issued may also be convertible into shares of Spectrum
Pharmaceuticals, Inc. common stock or another series of its preferred stock.
This prospectus provides a general description of the securities that we may offer hereunder.
Each time we sell securities hereunder, we will describe in a prospectus supplement, which we will
deliver with this prospectus, specific information about the offering and the terms of the
particular securities offered. In each prospectus supplement, we will include the following
information:
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the type and amount of securities that we propose to sell; |
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the public offering price of the securities; |
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the names of any underwriters, agents or dealers through or to which the securities will be sold; |
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any compensation of those underwriters, agents or dealers; |
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information about any securities exchanges or automated quotation systems on which the
securities will be listed or traded; |
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any risk factors applicable to the securities that we propose to sell; and |
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any other material information about the offering and sale of the securities. |
In addition, the prospectus supplement may also add, update or change the information
contained in this prospectus.
3
THE COMPANY
On March 7, 2008, we received approval from the U.S. Food and Drug Administration, or FDA, of
our new drug application, or NDA, for our drug product, Levoleucovorin for Injection (formerly,
ISO-Vorin TM ). We anticipate launching LEVOleucovorin in the U.S. market in mid-2008.
Also, during the fourth quarter of 2008, we will launch sumatriptan injection, the generic form of
GlaxoSmithKlines Imitrex ® injection, through our commercialization partner, Par
Pharmaceutical Companies, Inc. We are a biopharmaceutical company that acquires, develops and
commercializes a diversified portfolio of drug products, with a focus on oncology, urology and
other critical health challenges. We are focused on executing our business strategy, which is
comprised of the following four parts:
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Acquiring and developing a broad and diverse pipeline of late-stage
clinical and commercial products with a focus on oncology and urology. |
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We acquire and develop multiple novel, late-stage oncology drug
products that address niche markets. 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 early clinical process. Our strategy allows us to
leverage organizational, collaborative, commercial and scientific
efficiencies from a therapeutic focus on oncology and urology. |
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Establishing a commercial organization for LEVOleucovorin that will be
available if and when each of the other drug products in our pipeline
are approved. As we transform from a development to a commercial
organization, we are building a foundation for successful product
launches. |
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Continuing to build a team with significant drug development and
commercialization expertise in our areas of focus and creating a
culture of success that allows our people to thrive. |
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We have built the foundation of a team with significant experience in
oncology and urology drug development. We endeavor to leverage the
talents of our team and add people who have relevant experience. Our
team members have, in the past, been responsible for the development
of drugs such as adriamycin, cisplatin, carboplatin, paclitaxel,
Etoposide, Buspar, Cialis, Nefazodone and Stadol, among others. We
also have, and will continue to bring, commercialization experience to
the Company as we build our commercial infrastructure. |
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Leveraging the expertise of partners around the world in areas of
manufacturing, development and commercialization to assist us in the
execution of our strategy. |
We have incurred losses in every year of our existence and expect to continue to incur
operating losses for the next several years. We may never generate significant revenue or become
profitable because our drug product LEVOleucovoran for Injection may not achieve market acceptance
and all of our other proprietary drug candidates are currently either in clinical trials and our
clinical trials may fail, or we may not receive approval of the FDA, or even if approved, they may
not become commercially viable or achieve market acceptance. Since it is unlikely that we will be
able to generate the revenues necessary to finance our operations near-term, we will likely have to
seek additional capital through the sale of our securities. However, we do not currently have plans
to raise capital.
The pharmaceutical marketplace in which we operate is highly competitive, and includes many
large, well-established companies pursuing treatments for the indications we are pursuing.
Spectrum Pharmaceuticals, Inc. is a Delaware corporation that was originally incorporated in
Colorado as Americus Funding Corporation in December 1987, became NeoTherapeutics, Inc. in August
1996, was reincorporated in Delaware in June 1997, and was renamed Spectrum Pharmaceuticals, Inc.
in December 2002. Our principal executive offices are located at 157 Technology Drive, Irvine,
California 92618.
4
USE OF PROCEEDS
Unless we indicate otherwise in the applicable prospectus supplement, the net proceeds from
the sale of the securities offered from time to time hereby will be used for general corporate
purposes, including, without limitation, sales and marketing activities, clinical development,
making acquisitions of assets, businesses or securities, capital expenditures and for working
capital. When a particular series of securities is offered, the related prospectus supplement will
set forth our intended use of the net proceeds we receive from the sale of the securities. Pending
the application of the net proceeds, we may invest the proceeds in short-term, interest-bearing
instruments or other securities.
RATIO OF EARNINGS TO FIXED CHARGES
The following table sets forth our ratio of earnings to fixed charges for the periods
indicated:
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Year Ended December 31, |
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2007 |
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2005 |
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2003 |
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Ratio of earnings to fixed charges (1) |
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N/A |
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N/A |
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N/A |
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N/A |
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N/A |
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(1) |
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Earnings have been inadequate to cover fixed charges. The dollar
amount (in thousands) of the coverage deficiency in the five year
period ended December 31, 2007 was approximately $10,390, $12,286,
$18,642, $23,284, and $34,036 for the years 2003, 2004, 2005, 2006 and
2007, respectively. |
The ratios of earnings to fixed charges were computed by dividing earnings by fixed charges.
For this purpose, earnings consist of pre-tax loss before fixed charges included in the
determination of pre-tax loss. Fixed charges consist of interest costs, whether expensed or
capitalized, the amortization of debt discount and issuance costs, and the interest factor of
rental expense.
RATIO OF EARNINGS TO COMBINED FIXED CHARGES AND PREFERRED STOCK DIVIDENDS
The following table sets forth our ratio of earnings to combined fixed charges and preferred
stock dividends for the periods indicated:
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Year Ended December 31, |
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2007 |
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2006 |
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2003 |
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Ratio of earnings
to combined fixed
charges and
preferred share
dividends (1) |
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N/A |
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N/A |
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N/A |
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N/A |
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N/A |
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(1) |
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Earnings have been inadequate to cover fixed charges and preferred
stock dividends. The dollar amount of the coverage deficiency in the
five year period ended December 31, 2007 was approximately $10,792,
$12,556, $18,854, $23,445 and $34,055 for the years 2003, 2004, 2005,
2006 and 2007, respectively. |
The ratio of earnings to combined fixed charges and preferred stock dividends is calculated in
a similar manner to the ratio of earnings to fixed charges, except that preference dividends of
Spectrum Pharmaceuticals are combined with fixed charges on a pre-tax basis, assuming a 40% tax
rate. The deficiency amount is the amount of earnings required for a ratio of 1.0x.
5
FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference into this prospectus contain
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. Words such as anticipates, expects, intends, plans, believes, seeks, estimates,
and variations of such words and similar expressions are intended to identify such forward-looking
statements. These statements are based on current expectations, estimates and projections about our
industry, managements beliefs, and assumptions made by management. These statements are not
guarantees of future performance and are subject to certain risks, uncertainties and assumptions
that are difficult to predict; therefore, actual results may differ materially from those expressed
or forecasted in any forward-looking statements. The risks and uncertainties include those noted in
our SEC filings or any applicable prospectus supplement.
We urge you to consider these factors carefully in evaluating the forward-looking statements
contained in this prospectus and any prospectus supplement. All subsequent written or oral
forward-looking statements attributable to our company or persons acting on our behalf are
expressly qualified in their entirety by these cautionary statements. The forward-looking
statements included in this prospectus are made only as of the date of this prospectus. We
undertake no obligation to update publicly any forward-looking statements, whether as a result of
new information, future events or otherwise, except to the extent that we are required to do so by
law.
6
DESCRIPTION OF SECURITIES
The following is a general description of the terms and provisions of the securities we may
offer and sell by this prospectus. These summaries are not meant to be complete. This prospectus
and the applicable prospectus supplement will contain the material terms and conditions of each
security. The prospectus supplement may add, update or change the terms and conditions of the
securities as described in this prospectus.
DEBT SECURITIES
The following sets forth certain general terms and provisions of the indenture under which the
debt securities are to be issued, unless otherwise specified in a prospectus supplement. The
particular terms of the debt securities to be sold by us will be set forth in a prospectus
supplement relating to such debt securities.
The debt securities will represent unsecured general obligations of the Company, unless
otherwise provided in the prospectus supplement. As indicated in the applicable prospectus
supplement, the debt securities will either be senior debt or subordinated debt as described in the
applicable prospectus supplement. Unless otherwise specified in the applicable prospectus
supplement, the debt securities will be issued under an indenture between us and a trustee. The
form of indenture has been filed as an exhibit to the registration statement of which this
prospectus is a part, subject to such amendments or supplemental indentures as are adopted from
time to time. The following summary of certain provisions of that indenture does not purport to be
complete and is subject to, and qualified in its entirety by, reference to all the provisions of
that indenture, including the definitions therein of certain terms. Wherever particular sections or
defined terms of the indenture are referred to, it is intended that such sections or defined terms
shall be incorporated herein by reference.
General
The indenture does not limit the amount of debt securities that may be issued thereunder. The
applicable prospectus supplement with respect to any debt securities will set forth, if applicable,
the following terms of the debt securities offered pursuant thereto: (i) the title and series of
such debt securities, including CUSIP numbers; (ii) any limit upon the aggregate principal amount
of such debt securities of such title or series; (iii) whether such debt securities will be in
global or other form; (iv) the date(s) and method(s) by which principal and any premium on such
debt securities is payable; (v) interest rate or rates (or method by which such rate will be
determined), if any; (vi) the dates on which any such interest will be payable and the method of
payment; (vii) whether and under what circumstances any additional amounts are payable with respect
to such debt securities; (viii) the notice, if any, to holders of such debt securities regarding
the determination of interest on a floating rate debt security; (ix) the basis upon which interest
on such debt securities shall be calculated, if other than that of a 360 day year of twelve 30-day
months; (x) the place or places where the principal of and interest or additional amounts, if any,
on such debt securities will be payable; (xi) any redemption or sinking fund provisions; (xii) the
denominations of such debt securities; (xiii) any rights of the holders of such debt securities to
convert the debt securities into other securities or property; (xiv) the terms, if any, on which
payment of principal or any premium, interest or additional amounts on such debt securities will be
payable in a currency other than U.S. dollars; (xv) the terms, if any, by which the amount of
payments of principal or any premium, interest or additional amounts on such debt securities may be
determined by reference to an index, formula, financial or economic measure or other methods; (xvi)
if other than the principal amount hereof, the portion of the principal amount of such debt
securities that will be payable upon declaration of acceleration of the maturity thereof or
provable in bankruptcy; (xvii) any events of default or covenants in addition to or in lieu of
those described herein and remedies therefor; (xviii) whether such debt securities will be subject
to defeasance or covenant defeasance; (xix) the terms, if any, upon which such debt securities are
to be issuable upon the exercise of warrants; (xx) the trustee or trustees and any authenticating
or paying agents, transfer agents or registrars or any other agents with respect to such debt
securities; (xxi) the terms, if any, on which such debt securities will be subordinate to other
debt of the Company; and (xxii) any other specific terms of such debt securities and any other
deletions from or additions to or modifications of the indenture with respect to such debt
securities.
Debt securities may be presented for exchange, conversion or transfer in the manner, at the
places and subject to the restrictions set forth in the debt securities and the prospectus
supplement. Such services will be provided without charge, other than any tax or other governmental
charge payable in connection therewith, but subject to the limitations provided in the indenture.
7
The indenture does not contain any covenant or other specific provision affording protection
to holders of the debt securities in the event of a highly leveraged transaction or a change in
control of the Company, except to the limited extent described below under Consolidation,
Merger and Sale of Assets. The Companys Certificate of Incorporation also contains other
provisions which may prevent or limit a change of control. See Description of Capital Stock.
Modification and Waiver
The indenture provides that supplements to the indenture and the applicable supplemental
indentures may be made by the Company and the trustee for the purpose of adding any provisions to
or changing in any manner or eliminating any of the provisions of the indenture or of modifying in
any manner the rights of the holders of debt securities of a series under the indenture or the debt
securities of such series, with the consent of the holders of a majority (or such other amount as
is provided for a particular series of debt securities) in principal amount of the outstanding debt
securities issued under such indenture that are affected by the supplemental indenture, voting as a
single class; provided that such supplemental indenture may include provisions that state that no
such supplemental indenture may, without the consent of the holder of each such debt security
affected thereby, among other things: (a) change the stated maturity of the principal of, or any
premium, interest or additional amounts on, such debt securities, or reduce the principal amount
thereof, or reduce the rate or extend the time of payment of interest or any additional amounts
thereon, or reduce any premium payable on redemption thereof, or reduce the amount of the principal
of debt securities issued with original issue discount that would be due and payable upon an
acceleration of the maturity thereof or the amount thereof provable in bankruptcy, or change the
redemption provisions or adversely affect the right of repayment at the option of the holder, or
change the place of payment or currency in which the principal of, or any premium, interest or
additional amounts with respect to any debt security is payable, or impair or affect the right of
any holder of debt securities to institute suit for the payment thereof or, if such debt securities
provide therefor, any right of repayment at the option of the holder; (b) reduce the percentage of
outstanding debt securities of any series, the consent of the holders of which is required for any
such supplemental indenture, or the consent of whose holders is required for any waiver or reduce
the quorum required for voting; (c) modify any of the provisions of the sections of such indenture
relating to supplemental indentures with the consent of the holders, waivers of past defaults or
securities redeemed in part, except to increase any such percentage or to provide that certain
other provisions of such indenture cannot be modified or waived without the consent of each holder
affected thereby; or (d) make any change that adversely affects the right to convert or exchange
any security into or for common stock or other securities, cash or other property in accordance
with the terms of the applicable debt security.
The indenture provides that a supplemental indenture that changes or eliminates any covenant
or other provision of the indenture that has expressly been included solely for the benefit of one
or more particular series of debt securities, or that modifies the rights of the holders of such
series with respect to such covenant or other provision, shall be deemed not to affect the rights
under the indenture of the holders of debt securities of any other series, unless it intends to do
so.
The indenture provides that the Company and the applicable trustee may, without the consent of
the holders of any series of debt securities issued thereunder, enter into additional supplemental
indentures for one of the following purposes: (1) to evidence the succession of another corporation
to the Company and the assumption by any such successor of the covenants of the Company in such
indenture and in the debt securities issued thereunder; (2) to add to the covenants of the Company
or to surrender any right or power conferred on the Company pursuant to the Indenture; (3) to
establish the form and terms of debt securities issued thereunder; (4) to evidence and provide for
a successor trustee under such indenture with respect to one or more series of debt securities
issued thereunder or to provide for or facilitate the administration of the trusts under such
indenture by more than one trustee; (5) to cure any ambiguity, to correct or supplement any
provision in the indenture that may be inconsistent with any other provision of the indenture or to
make any other provisions with respect to matters or questions arising under such indenture which
shall not adversely affect the interests of the holders of any series of debt securities issued
thereunder in any material respect; (6) to add to, delete from or revise the conditions,
limitations and restrictions on the authorized amount, terms or purposes of issue, authentication
and delivery of securities under the indenture; (7)
8
to add any additional events of default with respect to all or any series of debt securities; (8)
to supplement any of the provisions of the indenture as may be necessary to permit or facilitate
the defeasance and discharge of any series of debt securities, provided that such action does not
adversely affect the interests of any holder of an outstanding debt security of such series or any
other security in any material respect; (9) to make provisions with respect to the conversion or
exchange rights of holders of debt securities of any series; (10) to amend or supplement any
provision contained in such indenture or any supplemental indenture, provided that no such
amendment or supplement shall materially adversely affect the interests of the holders of any debt
securities then outstanding; or (11) to qualify such indenture under the Trust Indenture Act of
1939.
Events of Default
Unless otherwise provided in any prospectus supplement, the following will be events of
default under the indenture with respect to each series of debt securities issued thereunder: (a)
default in the payment of principal (or premium, if any) or any additional amounts with respect to
such principal or premium on any series of the debt securities outstanding under the indenture when
due; (b) default in the payment of any interest or any additional amounts with respect to such
interest on any series of the debt securities outstanding under the indenture when due, continued
for 30 days; (c) default in the payment, if any, of any sinking fund installment when and as due by
the terms of any debt security of such series, subject to any cure period that may be specified in
any debt security of such series; (d) failure to perform any other covenant or warranty of the
Company contained in such indenture or such debt securities continued for 90 days after written
notice; (e) certain events of bankruptcy, insolvency or reorganization of the Company; and (f) any
other event of default provided in a supplemental indenture with respect to a particular series of
debt securities. Unless otherwise provided in any prospectus supplement, in case an event of
default other than a default specified in clause (e) above shall occur and be continuing with
respect to any series of such debt securities, the applicable trustee or the holders of not less
than 25% in aggregate principal amount of the debt securities of such series then outstanding (each
such series acting as a separate class) may declare the principal (or, in the case of discounted
debt securities, the amount specified in the terms thereof) of such series to be due and payable.
Unless otherwise provided in any prospectus supplement, if an event of default described in (e)
above shall occur and be continuing then the principal amount (or, in the case of discounted debt
securities, the amount specified in the terms thereof) of all the debt securities outstanding shall
be and become due and payable immediately, without notice or other action by any holder or the
applicable trustee, to the full extent permitted by law. Unless otherwise provided in any
prospectus supplement, any event of default with respect to particular series of debt securities
under such indenture may be waived by the holders of a majority in aggregate principal amount of
the outstanding debt securities of such series (voting as a class), except in each case a failure
to pay principal of or premium, interest or additional amounts, if any, on such debt securities or
a default in respect of a covenant or provision which cannot be modified or amended without the
consent of each holder affected thereby.
The indenture provides that the applicable trustee may withhold notice to the holders of any
default with respect to any series of debt securities (except in payment of principal of or
interest or premium on, or sinking fund payment in respect of, the debt securities) if the
applicable trustee considers it in the interest of holders to do so.
The indenture contains a provision entitling the applicable trustee to be indemnified by the
holders before proceeding to exercise any trust or power under such indenture at the request of
such holders. The indenture provides that the holders of a majority in aggregate principal amount
of the then outstanding debt securities of any series may direct the time, method and place of
conducting any proceedings for any remedy available to the applicable trustee or of exercising any
trust or power conferred upon the applicable trustee with respect to the debt securities of such
series; provided, however, that the applicable trustee may decline to follow any such direction
if, among other reasons, the applicable trustee determines in good faith that the actions or
proceedings as directed may not lawfully be taken or would be unduly prejudicial to the holders of
the debt securities of such series not joining in such direction. The right of a holder to
institute a proceeding with respect to the applicable indenture will be subject to certain
conditions precedent including, without limitation, that the holders of not less than 25% in
aggregate principal amount of the debt securities of such series then outstanding under such
indenture make a written request upon the applicable trustee to exercise its powers under such
indenture, indemnify the applicable trustee and afford the applicable trustee reasonable
opportunity to act, but the holder has an absolute right to receipt of the principal of, premium,
if any, and interest when due on the debt securities, to require conversion of debt securities if
such indenture provides for convertibility at the option of the holder and to institute suit for
the enforcement thereof.
9
Consolidation, Merger and Sale of Assets
Unless otherwise provided in any prospectus supplement, the indenture will provide that the
Company may not consolidate with, merge into or sell, convey or lease all or substantially all of
its assets to any person unless the successor person assumes the Companys obligations on the debt
securities issued thereunder, and under such indenture.
Certain Covenants
Existence. Except as permitted under Consolidation, Merger or Sale of Assets, the
indenture requires the Company to do or cause to be done all things necessary to preserve and keep
in full force and effect its corporate existence, rights (by certificate of incorporation, bylaws
and statute) and franchises; provided, however, that the Company will not be required to preserve
any right or franchise if its board of directors determines that the preservation thereof is no
longer desirable in the conduct of its business.
Calculation of Original Issue Discount. The Company shall file with the trustee promptly at
the end of each calendar year a written notice specifying the amount of original issue discount
accrued on outstanding securities at the end of such year and any other specific information as may
then be relevant under the Internal Revenue Code of 1986, as amended.
Additional Covenants. Any additional covenants of the Company with respect to any series of
debt securities will be set forth in the prospectus supplement relating thereto.
Conversion Rights
The terms and conditions, if any, upon which the debt securities are convertible into common
stock or preferred stock will be set forth in the applicable prospectus supplement relating
thereto. Such terms will include, if applicable, the conversion price (or manner of calculation
thereof), the conversion period, provisions as to whether conversion will be at the option of the
holders or the Company, the events requiring an adjustment of the conversion price and provisions
affecting conversion in the event of redemption of such debt securities and any restrictions on
conversion.
Redemption; Repurchase at the Option of the Holder; Sinking Fund
The terms and conditions, if any, upon which (i) the debt securities are redeemable at the
option of the Company, (ii) the holder of debt securities may cause the Company to repurchase such
debt securities or (iii) the debt securities are subject to any sinking fund will be set forth in
the applicable prospectus supplement relating thereto.
Repurchases on the Open Market
The Company or any affiliate of the Company may at any time or from time to time repurchase
any debt security in the open market or otherwise. Such debt securities may, at the option of the
Company or the relevant affiliate of the Company, be held, resold or surrendered to the trustee for
cancellation.
Discharge, Defeasance and Covenant Defeasance
The indenture provides, with respect to each series of debt securities issued thereunder, that
the Company may terminate its obligations under such debt securities of a series and such indenture
with respect to debt securities of such series if: (i) all debt securities of such series
previously authenticated and delivered, with certain exceptions, have been delivered to the
applicable trustee for cancellation and the Company has paid all sums payable by it under the
indenture; or (ii) (A) the debt securities of such series mature within one year or all of them are
to be called for redemption within one year under arrangements satisfactory to the applicable
trustee for giving the notice of redemption, (B) the Company irrevocably deposits in trust with the
applicable trustee, as trust funds solely for the benefit of the holders of such debt securities,
for that purpose, money or U.S. government obligations or a combination thereof sufficient (unless
such funds consist solely of money, in the opinion of a nationally recognized
10
firm of independent public accountants expressed in a written certification thereof delivered to
the applicable trustee), without consideration of any reinvestment, to pay principal of and
interest on the debt securities of such series to maturity or redemption, as the case may be, and
to pay all other sums payable by it under such indenture, and (C) the Company delivers to the
applicable trustee an officers certificate and an opinion of counsel, in each case stating that
all conditions precedent provided for in such indenture relating to the satisfaction and discharge
of such indenture with respect to the debt securities of such series have been complied with. With
respect to the foregoing clause (i), only the Companys obligations to compensate and indemnify the
applicable trustee under the indenture shall survive. With respect to the foregoing clause (ii)
only the Companys obligations to execute and deliver debt securities of such series for
authentication, to maintain an office or agency in respect of the debt securities of such series,
to have moneys held for payment in trust, to register the transfer or exchange of debt securities
of such series, to deliver debt securities of such series for replacement or to be canceled, to
compensate and indemnify the applicable trustee and to appoint a successor trustee, and its right
to recover excess money held by the applicable trustee shall survive until such debt securities are
no longer outstanding. Thereafter, only the Companys obligations to compensate and indemnify the
applicable trustee and its right to recover excess money held by the applicable trustee shall
survive.
The indenture provides that the Company (i) will be deemed to have paid and will be discharged
from any and all obligations in respect of the debt securities issued thereunder of any series, and
the provisions of such indenture will, except as noted below, no longer be in effect with respect
to the debt securities of such series and (ii) may omit to comply with any term, provision,
covenant or condition of such indenture, and such omission shall be deemed not to be an event of
default under clause (d) of the first paragraph of Events of Default with respect to the
outstanding debt securities of such series; provided that the following conditions shall have been
satisfied: (A) the Company has irrevocably deposited in trust with the applicable trustee as trust
funds solely for the benefit of the holders of the debt securities of such series, for payment of
the principal of and interest of the debt securities of such series, which funds shall consist of
cash or U.S. Government Obligations or a combination thereof sufficient (, in the opinion of a
nationally recognized firm of independent public accountants expressed in a written certification
thereof delivered to the applicable trustee, without consideration of any reinvestment , to pay and
discharge the principal of and accrued interest on the outstanding debt securities of such series
to maturity or earlier redemption (irrevocably provided for under arrangements satisfactory to the
applicable trustee), as the case may be; (B) such deposit will not result in a breach or violation
of, or constitute a default under, such indenture or any other material agreement or instrument to
which the Company is a party or by which it is bound; (C) no default with respect to such debt
securities of such series shall have occurred and be continuing on the date of such deposit; (D)
the Company shall have delivered to such trustee an opinion of counsel that (1) the holders of the
debt securities of such series will not recognize income, gain or loss for Federal income tax
purposes as a result of the Companys exercise of its option under this provision of such indenture
and will be subject to federal income tax on the same amount and in the same manner and at the same
times as would have been the case if such deposit and defeasance had not occurred, and (2) the
holders of the debt securities of such series have a valid security interest in the trust funds
subject to no prior liens under the Uniform Commercial Code; and (E) the Company has delivered to
the applicable trustee an officers certificate and an opinion of counsel, in each case stating
that all conditions precedent provided for in such indenture relating to the defeasance
contemplated have been complied with. In the case of legal defeasance under clause (i) above, the
opinion of counsel referred to in clause (D)(l) above may be replaced by a ruling directed to the
applicable trustee received from the Internal Revenue Service to the same effect. Subsequent to a
legal defeasance under clause (i) above, the Companys obligations to execute and deliver debt
securities of such series for authentication, to maintain an office or agency in respect of the
debt securities of such series, to have moneys held for payment in trust, to register the transfer
or exchange of debt securities of such series, to deliver debt securities of such series for
replacement or to be canceled, to compensate and indemnify the applicable trustee and to appoint a
successor trustee, and its right to recover excess money held by the applicable trustee shall
survive until such debt securities are no longer outstanding. After such debt securities are no
longer outstanding, in the case of legal defeasance under clause (i) above, only the Companys
obligations to compensate and indemnify the applicable trustee and its right to recover excess
money held by the applicable trustee shall survive.
Applicable Law
The indenture provides that the debt securities and the indenture will be governed by and
construed in accordance with the laws of the State of New York.
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CAPITAL STOCK
Our authorized capital stock consists of 100,000,000 shares of common stock, $0.001 par value,
and 5,000,000 shares of preferred stock, $0.001 par value. Our Certificate of Incorporation, as
amended to date, does not authorize any other classes of capital stock.
Common Stock
As of March 31, 2008 there were 31,461,396 shares of common stock outstanding and
approximately 389 shareholders of record. 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. No
dividend on our common stock may be paid unless, at the time of such payment, we have on hand cash
and other liquid assets sufficient to pay in full, in cash, the liquidation preference that would
be payable to the holders of the preferred stock, if any, as if such liquidation preference were
then payable. Subject to this preference and the preferences that may be applicable to the holders
of any other 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 Pharmaceuticals, before any
distribution of our assets shall be made to or set apart for the holders of our common stock, the
holders, if any, 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 Designations for the 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.
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 a Rights Agreement between us and ComputerShare Trust Company, N.A., as rights
agent, filed with the Securities and Exchange Commission 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 Securities and
Exchange Commission on August 14, 2003, as Exhibit 4.1 to our Form 10-Q for the period ended June
30, 2003, Amendments No. 2 and No. 3 dated May 10, 2004, filed with the Securities and Exchange
Commission on May 17, 2004 as Exhibits 4.1 and 4.2 respectively to our Form 10-Q for the period
ended March 30, 2004, the Fourth Amendment dated July 7, 2006, filed as Exhibit 4.1 to our Form 8-K
filed with the Securities and Exchange Commission on July 12, 2006, and Amendment No. 5 dated
September 26, 2006, filed with the Securities and Exchange Commission on November 3, 2006 as
Exhibit 4.2 to our Form 10-Q for the period ended September 30, 2006.
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Certain Provisions of Delaware Law and of the Companys Certificate of Incorporation and Bylaws
The following paragraphs summarize certain provisions of the Delaware General Corporation Law
and the Companys Certificate of Incorporation and Bylaws. The summary does not purport to be
complete and is subject to and qualified in its entirety by reference to the Delaware General
Corporation Law and to the Companys Certificate of Incorporation and Bylaws, copies of which are
on file with the Commission. 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 Pharmaceuticals 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.
In addition to our rights agreement, our Certificate of Incorporation and our Bylaws, certain
provisions of Delaware law may make the acquisition of the company by tender offer, a proxy contest
or otherwise, or the removal of our officers and directors, more difficult. For example, we are
subject to the business combination statute of the DGCL, an anti-takeover law enacted in 1988.
Section 203 of the DGCL prohibits certain publicly-held Delaware corporations from engaging in a
business combination with an interested stockholder for a period of three years following the time
such person became an interested stockholder unless the business combination is approved in a
specified manner. Generally, an interested stockholder is a person who, together with its
affiliates and associates, owns 15% or more of the corporations voting stock, or is affiliated
with the corporation and owns or owned 15% of the corporations voting stock within three years
before the business combination. In addition, our Certificate of Incorporation sets forth
additional required approvals for business combinations with (1) a stockholder that owns 5% or more
of our voting stock, or (2) is an affiliate or associate of ours and was the owner of 5% or more of
our voting stock at any time within the three-year period prior to the determination time, or (3)
is an affiliate or associate of the persons described in (1) and (2).
Transfer Agent and Registrar
Our common stock is listed under the symbol SPPI on the Nasdaq Global Market. Computershare
Trust Company, N.A. is the Transfer Agent and Registrar for our common stock.
Preferred Stock
The Company is authorized to issue a total of 5,000,000 shares of preferred stock. Of the
5,000,000 authorized shares, the Company is authorized to issue 1,000,000 shares of Series B Junior
Participating Preferred Stock and 2,000 shares of Series E Convertible Voting Preferred Stock. As
of March 31, 2008, 170 shares of Series E Convertible Voting Preferred Stock were issued and
outstanding.
Each share of Series E Preferred Stock is convertible into a number of shares of Spectrum
Pharmaceuticals common stock equal to the quotient obtained by dividing the sum of a stated value
of $10,000 by a conversion price of $5.00, subject to adjustment in certain circumstances. There
are no dividends payable on the Preferred Stock.
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Each share of Series E Preferred Stock has a liquidation preference equal to 120% of the
stated value of $10,000 plus any declared and unpaid dividends on such share, subject to adjustment
in certain circumstances.
Holders of our Series E Preferred Stock have full voting rights and powers equal to the voting
rights and powers of holders of common stock, and are entitled to the number of votes equal to the
number of shares of common stock into which their shares of Series E Preferred Stock can be
converted. Pursuant to the Certificates of Designations for the Series E Preferred Stock, the
number of shares of our common stock that may be acquired by any holder of Series E Preferred Stock
upon any conversion of the preferred stock, or that shall be entitled to voting rights, is limited
to the extent necessary to ensure that following such conversion, the number of shares of our
common stock then beneficially owned by such holder and any other person or entities whose
beneficial ownership of common stock would be aggregated with the holders for purposes of the
Securities and Exchange Act of 1934, as amended, does not exceed 4.95% of the total number of
shares of our common stock then outstanding.
Terms
Preferred stock may be issued from time to time, in one or more series, as authorized by the
board of directors. The prospectus supplement relating to the preferred shares offered thereby will
include specific terms of any preferred shares offered, including, if applicable:
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the title of the shares of preferred stock; |
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the number of shares of preferred stock offered, the liquidation preference per share and the offering price of
the shares of preferred stock; |
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the dividend rate(s), period(s) and/or payment date(s) or method(s) of calculation thereof applicable to the
shares of preferred stock; |
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whether the shares of preferred stock are cumulative or not and, if cumulative, the date from which dividends
on the shares of preferred stock shall accumulate; |
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the procedures for any auction and remarketing, if any, for the shares of preferred stock; |
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the provision for a sinking fund, if any, for the shares of preferred stock; |
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the provision for redemption, if applicable, of the shares of preferred stock; |
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any listing of the shares of preferred stock on any securities exchange; |
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the terms and conditions, if applicable, upon which the shares of preferred stock will be convertible into
common shares, including the conversion price (or manner of calculation thereof); |
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a discussion of federal income tax considerations applicable to the shares of preferred stock; |
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the relative ranking and preferences of the shares of preferred stock as to dividend rights and rights upon
liquidation, dissolution or winding up of our affairs; |
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any limitations on issuance of any series or class of shares of preferred stock ranking senior to or on a
parity with such series or class of shares of preferred stock as to dividend rights and rights upon
liquidation, dissolution or winding up of our affairs; |
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any other specific terms, preferences, rights, limitations or restrictions of the shares of preferred stock; and |
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any voting rights of such preferred stock. |
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Transfer Agent
The transfer agent and registrar for any series or class of preferred stock will be set forth
in the applicable prospectus supplement.
WARRANTS
As of March 31, 2008, we had warrants to purchase 9,679,829 shares of our common stock
outstanding, held of record by approximately 59 security holders, of which warrants to purchase
9,562,329 shares of our common stock were exercisable. We typically issue warrants to purchase
shares of our common stock to investors as part of a financing transaction, or in connection with
services rendered by placement agents and outside consultants. Our outstanding warrants expire at
varying dates commencing May 2008 through September 2013.
Terms
We may issue warrants for the purchase of our preferred stock, common stock or units of two or
more of these types of securities. Warrants may be issued independently or together with preferred
stock or common stock and may be attached to or separate from these securities. Each series of
warrants will be issued under a separate warrant agreement. We will distribute a prospectus
supplement with regard to each issue or series of warrants. Each such prospectus supplement will
describe, as applicable:
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the title of the warrants; |
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the aggregate number of warrants to be issued and currently outstanding, if any; |
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the price or prices at which the warrants will be issued; |
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the number or principal amount of securities purchasable upon exercise of the
warrants and the exercise price of each warrant; |
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the procedures and conditions relating to the exercise of the warrants including: |
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the date on which the right to exercise the warrants will commence and the date on which the right will expire; |
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the maximum or minimum number of the warrants which may be exercised at any time; and |
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any limitations relating to the exchange and exercise of such warrants; |
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any provisions for adjustment of the number or amount of shares of our preferred
or common stock receivable upon exercise of the warrants or the exercise price of
the warrants; |
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in the case of warrants to purchase preferred stock, the designation, stated
value and terms, such as liquidation, dividend, conversion and voting rights, of
the series of preferred stock purchasable upon exercise of the warrants; |
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if applicable, the number of warrants issued with each share of our preferred or
common stock, and the date on and after which the warrants and the related
securities will be separately transferable; |
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if applicable, a discussion of any material federal income tax considerations; and |
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any other material terms of such warrants. |
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Exercise of Warrants
Each warrant will entitle the holder of the warrant to purchase the securities, at the
exercise price as shall be set forth in, or be determinable as set forth in, the prospectus
supplement relating to the warrants. Warrants may be exercised at any time up to the close of
business on the expiration date set forth in the applicable prospectus supplement. After the close
of business on the expiration date, unexercised warrants will become void.
Upon receipt of payment and the warrant certificate properly completed and duly executed at
the corporate trust office of the warrant agent or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the securities purchased upon such exercise.
If less than all of the warrants represented by a warrant certificate are exercised, a new warrant
certificate will be issued for the remaining warrants.
Prior to the exercise of any warrants, holders of the warrants will not have any of the rights
of holders of the securities purchasable upon exercise, including the right to vote or to receive
any payments of dividends on the preferred or common stock purchasable upon exercise.
Certificates for warrants to purchase securities will be exchangeable for new warrant
certificates of different denominations to the extent set forth in the prospectus supplement.
UNITS
As specified in the applicable prospectus supplement, units will be comprised of two or more
of the following securities in any combination: debt securities, preferred stock, common stock and
warrants. You should refer to the applicable prospectus supplement for:
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all terms of the units and of the debt securities, preferred stock, common stock and warrants
comprising the units, including whether and under what circumstances the securities comprising
the units may or may not be traded separately; |
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a description of the terms of any unit agreement governing the units; and |
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a description of the provisions for the payment, settlement, transfer or exchange of the units. |
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PLAN OF DISTRIBUTION
The securities that may be offered by this prospectus may be sold:
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through agents; |
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to or through underwriters; |
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to or through broker-dealers (acting as agent or principal); |
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in at the market offerings within the meaning of Rule 415(a)(4) of the Securities
Act, to or through a market maker or into an existing trading market, on an exchange,
or otherwise; |
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directly to purchasers, through a specific bidding or auction process or otherwise; or |
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through a combination of any such methods of sale. |
Agents, underwriters or broker-dealers may be paid compensation for offering and selling the
securities. That compensation may be in the form of discounts, concessions or commissions to be
received from us, from the purchasers of the securities or from both us and the purchasers. The
compensation received may be in excess of customary discounts, concessions or commissions. Any
underwriters, dealers, agents or other investors participating in the distribution of the
securities may be deemed to be underwriters, as that term is defined in the Securities Act, and
compensation and profits received by them on sale of the securities may be deemed to be
underwriting commissions, as that term is defined in the rules promulgated under the Securities
Act.
Each time the securities are offered by this prospectus, the prospectus supplement, if
required, will set forth:
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the name of any underwriter, dealer or agent involved in the offer and sale of the securities; |
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the terms of the offering; |
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any discounts concessions or commissions and other items constituting compensation received by
the underwriters, broker-dealers or agents; |
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any over-allotment option under which any underwriters may purchase additional securities from us; |
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any initial public offering price; |
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any discounts or concessions allowed or reallowed or paid to dealers; |
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any securities exchanges on which the securities may be listed; and |
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the anticipated date of delivery of the securities. |
The securities may be sold at a fixed price or prices, which may be changed, at market prices
prevailing at the time of sale, at prices relating to the prevailing market prices or at negotiated
prices. The distribution of securities may be effected from time to time in one or more
transactions, by means of one or more of the following transactions, which may include crosses or
block trades:
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exchange offers or other transactions on the Nasdaq Global Market or
any other organized market where the securities may be traded; |
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in the over-the-counter market; |
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in negotiated transactions; |
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through put or call option transactions relating to the securities; |
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under delayed delivery contracts or other contractual commitments; or |
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a combination of such methods of sale. |
If underwriters are used in a sale, securities will be acquired by the underwriters for their
own account and may be resold from time to time in one or more transactions. Securities may be
offered to the public either through underwriting syndicates represented by one or more managing
underwriters or directly by one or more firms acting as underwriters. If an underwriter or
underwriters are used in the sale of securities, an underwriting agreement will be executed with
the underwriter or underwriters at the time an agreement for the sale is reached. This prospectus
and the prospectus supplement will be used by the underwriters to resell the securities.
To comply with the securities laws of certain states, if applicable, the securities offered by
this prospectus will be offered and sold in those states only through registered or licensed
brokers or dealers.
Agents, underwriters and dealers may be entitled under agreements entered into with us to
indemnification by us against specified liabilities, including liabilities incurred under the
Securities Act, or to contribution by us to payments they may be required to make in respect of
such liabilities. The prospectus supplement will describe the terms and conditions of such
indemnification or contribution. Some of the agents, underwriters or dealers, or their respective
affiliates may be customers of, engage in transactions with or perform services for us in the
ordinary course of business. We will describe in the prospectus supplement naming the underwriter
the nature of any such relationship.
Our common stock is listed on the Nasdaq Global Market. Unless otherwise specified in the
applicable prospectus supplement, each other class or series of securities issued will be a new
issue with no established trading market. We may elect to list any other class or series of
securities on any exchange, but we are not currently obligated to do so. It is possible that one or
more underwriters, if any, may make a market in a class or series of securities, but the
underwriters will not be obligated to do so and may discontinue any market making at any time
without notice. We cannot give any assurance as to the liquidity of the trading market for any of
the securities.
Certain persons participating in the offering may engage in over-allotment, stabilizing
transactions, short-covering transactions and penalty bids in accordance with Regulation M under
the Exchange Act. We make no representation or prediction as to the direction or magnitude of any
effect that such transactions may have on the price of the securities. For a description of these
activities, see the information under the heading Underwriting in the applicable prospectus
supplement.
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WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement on Form S-3 that we filed with the SEC
registering the securities that may be offered and sold hereunder. The registration statement,
including exhibits thereto, contains additional relevant information about us and these securities
that, as permitted by the rules and regulations of the SEC, we have not included in this
prospectus. A copy of the registration statement can be obtained at the address set forth below.
You should read the registration statement for further information about us and these securities.
We file annual, quarterly and special reports, proxy statements and other information with the
SEC under the Securities Exchange Act of 1934, as amended, or the Exchange Act. You may read and
copy this information at the following SEC location:
Public Reference Room
100 F Street, N.E.
Washington, D.C. 20549
You may obtain information on the operation of the Public Reference Room by calling the SEC at
(800) SEC-0330. The SEC also maintains a web site that contains reports, proxy statements,
information statements and other information about issuers, like Spectrum Pharmaceuticals, Inc.,
who file electronically with the SEC. The address of that web site is www.sec.gov.
In addition, our common stock is listed on the Nasdaq Global Market and similar information
concerning us can be inspected and copied at the offices of The Nasdaq Stock Market, One Liberty
Plaza, 165 Broadway, New York, NY 10006.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference information into this prospectus. This means
that we can disclose important information about us and our financial condition to you by referring
you to another document filed separately with the SEC. The information incorporated by reference is
considered to be part of this prospectus. This prospectus incorporates by reference the documents
listed below that we have previously filed with the SEC:
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Our Annual Report on Form 10-K for the year ended December 31, 2007 filed with the SEC on March 14, 2008; |
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Our Current Reports on Form 8-K filed with the SEC on March 11, 2008, March 27, 2008 and April 30, 2008; |
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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
amendment 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 amendment or reports filed for the purpose of updating such
description. |
We also incorporate by reference all documents that we file with the SEC after the date of
this prospectus pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act and prior to the
sale of all securities registered hereunder or termination of the registration statement. Nothing
in this prospectus shall be deemed to incorporate information furnished but not filed with the SEC.
Any statement contained in this prospectus or in a document incorporated or deemed to be
incorporated by reference in this prospectus shall be deemed to be modified or superseded for
purposes of this prospectus to the extent that a statement contained herein or in the applicable
prospectus supplement or in any other subsequently
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filed document which also is or is deemed to be incorporated by reference modifies or supersedes
the statement. Any statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this prospectus.
You may request a copy of the filings incorporated herein by reference, including exhibits to
such documents that are specifically incorporated by reference, at no cost, by writing or calling
us at the following address or telephone number:
William N. Pedranti, Esq.
Vice President, General Counsel
Spectrum Pharmaceuticals, Inc.
157 Technology Drive
Irvine, California 92618
Telephone: (949) 788-6700
Statements contained in this prospectus as to the contents of any contract or other documents
are not necessarily complete, and in each instance investors are referred to the copy of the
contract or other document filed as an exhibit to the registration statement, each such statement
being qualified in all respects by such reference and the exhibits and schedules thereto.
EXPERTS
Our consolidated financial statements appearing in our Annual Report on Form 10-K for the year
ended December 31, 2007 and the effectiveness of internal control over financial reporting as of
December 31, 2007 included therein have been audited by Kelly & Company, our independent registered
public accounting firm, as set forth in its reports included therein, and incorporated by reference
in this prospectus and elsewhere in the registration statement. Our financial statements and
managements assessment are incorporated herein by reference in reliance upon such reports given,
on the authority of Kelly & Company as experts in accounting and auditing.
LEGAL MATTERS
Gibson, Dunn & Crutcher LLP of Irvine, California will issue an opinion with respect to the
validity of the securities to be offered and sold by this prospectus. If counsel for any
underwriters passes on legal matters in connection with an offering of the securities described in
this prospectus, we will name that counsel in the prospectus supplement relating to that offering.
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