e424b5
Filed pursuant to Rule
424(b)(5)
Registration Statement No. 333-121612
The information in this prospectus supplement and the accompanying prospectus is not complete
and may be changed. This prospectus supplement and the accompanying prospectus are not an offer to
sell these securities and are not soliciting an offer to buy these securities in any state where
the offer or sale is not permitted.
Subject to Completion
Preliminary Prospectus Supplement dated September 14, 2005
PROSPECTUS SUPPLEMENT
(To prospectus dated January 24, 2005)
UP TO 6,517,691 SHARES OF COMMON STOCK
AND WARRANTS TO PURCHASE UP TO 3,258,845 SHARES OF COMMON STOCK
OF
SPECTRUM PHARMACEUTICALS, INC.
This prospectus supplement relates to an offering by us on a best efforts basis of up
to 6,517,691 shares of our common stock at a purchase price of $5.37 per share, and warrants to
purchase up to 3,258,845 shares of our common stock at an exercise price of $6.62 per share, to
certain institutional investors for aggregate proceeds of approximately $35,000,000. Each investor
purchasing shares of our common stock in this offering will receive warrants to purchase one share
of our common stock for every two shares of our common stock purchased by the investor in the
offering. In connection with this offering, we will pay fees or commissions to one or more
placement agents and/or finders. See Plan of Distribution on page S-20 for more information
regarding these potential arrangements.
You should read this prospectus supplement, the accompanying prospectus, and the documents
incorporated by reference herein and therein, carefully before you invest. Such documents contain
information you should consider when making your investment decision. The information included in
the registration statement on Form S-3 (No. 333-121612) filed with the Securities and Exchange
Commission on December 23, 2004, as amended is hereby incorporated by reference into this
prospectus supplement.
Our common stock is traded on the Nasdaq National Market under the symbol SPPI. On
September 13, 2005, the last sale price of our common stock on the Nasdaq National Market was $5.36
per share. As of September 9, 2005, we had 15,362,574 shares of our common stock outstanding.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE RISK FACTORS ON PAGE S-4
OF THIS PROSPECTUS SUPPLEMENT AS WELL AS ON PAGE 21 OF OUR ANNUAL REPORT ON FORM 10-K AND ON PAGE
26 OF OUR QUARTERLY REPORT ON FORM 10-Q, FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MARCH
15, 2005 AND AUGUST 9, 2005, RESPECTIVELY, AS WELL AS THE RISK FACTORS IN THE ACCOMPANYING
PROSPECTUS AND THE DOCUMENTS INCORPORATED BY REFERENCE HEREIN AND THEREIN TO READ ABOUT FACTORS YOU
SHOULD CONSIDER 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 passed upon the accuracy or adequacy of this
prospectus supplement or the accompanying prospectus. Any representation to the contrary is a
criminal offense.
The date of this prospectus supplement is September _____, 2005.
S-1
TABLE OF CONTENTS
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S-3 |
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S-19 |
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S-19 |
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S-20 |
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S-20 |
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S-22 |
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S-24 |
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S-24 |
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S-24 |
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S-24 |
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S-26 |
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S-29 |
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You should rely only on the information contained or incorporated by reference in this prospectus
supplement and the accompanying prospectus that is also part of this document. We have not
authorized anyone to provide information different from that contained or incorporated in this
prospectus supplement and the accompanying prospectus. We are offering to sell shares of common
stock and /or common stock warrants only in jurisdictions where offers and sales are permitted.
The information contained or incorporated in this prospectus supplement and the accompanying
prospectus is accurate only as of the date of such information, regardless of the time of delivery
of this prospectus supplement and the accompanying prospectus or of any sale of our common stock
and/or common stock warrants.
ABOUT SPECTRUM PHARMACEUTICALS
We are a specialty pharmaceutical company engaged in the business of acquiring, developing and
commercializing prescription drug products for various indications. Our business model is to
acquire and develop a diversified portfolio of proprietary and generic drug products, with a mix of
near-term and long-term revenue potential. While our primary strategic focus is on proprietary drug
products addressing cancer and other unmet medical needs, we are also leveraging our developmental
and regulatory capabilities, and those of our strategic alliance partners, to enhance the potential
for realizing near-term revenues by taking advantage of opportunities for developing and
commercializing select generic drug products with a focus on specific niche categories. We plan to
execute our business strategy by attracting and retaining talented people, entering into strategic
business alliances, and maintaining a strong cash position.
As of the date of filing this prospectus supplement, we have seven proprietary drug product
candidates under development: satraplatin, EOquin, elsamitrucin, Ozarelix (formerly, SPI-153),
RenaZorb, SPI-1620 and lucanthone, two generic drugs for ciprofloxacin tablets and carboplatin
injection, approved for marketing by the United States Food and Drug Administration (FDA) and ten
Abbreviated New Drug Applications, or ANDAs, pending at the FDA. We plan to continue to evaluate
acquisitions, or in-licensing, of additional promising clinical-stage as well as
near-clinical-stage drugs from other companies and institutions; and expect to file additional
S-2
ANDAs in 2005. In addition, we plan to seek additional strategic alliances to manufacture, develop
and market our current and future drug products.
Unless the context otherwise requires, all references to the Company, we, us, our,
Spectrum and Spectrum Pharmaceuticals refer to Spectrum Pharmaceuticals, Inc. and its
subsidiaries, as a consolidated entity. We primarily conduct all our activities as Spectrum
Pharmaceuticals.
We have incurred losses in every year of our existence and expect to continue to incur
significant operating losses for the next several years. We have not generated significant
revenues from product sales and there is no assurance that significant revenue from product sales
will ever be achieved. There is no assurance that any of our currently proposed products will ever
be successfully developed, receive and maintain governmental regulatory approvals, become
commercially viable or achieve market acceptance.
The pharmaceutical marketplace in which we operate is highly competitive, and includes many
large, well-established companies pursuing treatments for the applications we are pursuing. Please
also read our discussion of competition matters in the RISK FACTORS section of this prospectus
supplement.
This prospectus supplement relates to an offering by us on a best efforts basis of up to
6,517,691 shares of our common stock at a purchase price of $5.37 per share, and warrants to
purchase up to 3,258,845 shares of our common stock at an exercise price of $6.62 per share, to
certain individual and institutional investors for aggregate gross proceeds of approximately
$35,000,000. In connection with this offering, we will pay fees or commissions to one or more
placement agents and/or finders. See Plan of Distribution
on page S-20 for more information
regarding these potential arrangements.
As allowed by SEC rules, this prospectus supplement does not contain all the information you
can find in the registration statement, the exhibits to the registration statement or the
accompanying prospectus. For further information, we refer you to the registration statement,
including its exhibits and schedules and the prospectus. Statements contained in this prospectus
supplement about the provisions or contents of any contract, agreement or any other document are
not necessarily complete. For each of these contracts, agreements or documents filed as an exhibit
to the registration statement, we refer you to the actual exhibit for a more complete description
of the matters involved. You should not assume that the information in this prospectus supplement
is accurate as of any date other than the date on the front of this document. For further
information about us or the securities offered under this prospectus supplement, you should refer
to the registration statement and the prospectus, which you can obtain from the SEC as described
below under the heading Where You Can Find More Information.
Spectrum Pharmaceuticals, Inc. is a Delaware corporation which 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 executive offices are located at 157 Technology Drive, Irvine, California
92618. Our telephone number is (949) 788-6700. Our web site address is www.spectrumpharm.com.
Information contained in our web site does not constitute part of this prospectus supplement.
FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the documents incorporated by
reference herein and therein, contain forward-looking statements that are based on current
expectations, estimates and projections about our industry, managements beliefs, and assumptions
made by management. Forward-looking statements include statements regarding our future product
development activities and costs, the revenue potential of our product candidates, the timing and
likelihood of achieving development milestones and product revenues, the sufficiency of our capital
resources, and other statements containing forward-looking words, such as, believes, may,
will, expects, intends, estimates, anticipates, plans, seeks, or continues and
variations of such words and similar expressions. These statements are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and are included in this prospectus supplement in
reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements are based on the beliefs of the Companys management as well as
assumptions made by and information currently available to the Companys
S-3
management. Readers should not put undue reliance on these forward-looking statements.
Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot
be predicted or quantified; therefore, our actual results may differ materially from those
described in any forward-looking statements. Factors that might cause such a difference include,
but are not limited to, those discussed below, including under the heading Risk Factors below.
These factors include, but are not limited to:
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our ability to successfully develop, obtain regulatory approvals for and market our products; |
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our ability to generate and maintain sufficient cash resources to increase investment in our business; |
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our ability to identify new product candidates; |
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the timing or results of pending or future clinical trials; |
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actions by the FDA and other regulatory agencies; |
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demand and market acceptance for our approved products; and |
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the effect of changing economic conditions. |
The risks and uncertainties include those noted in Risk Factors in our Annual Report and
Quarterly Report referenced above, those in the accompanying prospectus and those in the documents
incorporated by reference herein and therein.
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 or regulations. We also may make additional disclosures in our Annual Report on Form
10-K, our definitive proxy statement filed in connection with our Annual Meeting of Stockholders,
our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K that we may file from time
to time with the Securities and Exchange Commission.
RISK FACTORS
An investment in our common stock involves a high degree of risk. Our business, financial
condition, operating results and prospects can be impacted by a number of factors, any one of which
could cause our actual results to differ materially from recent results or from our anticipated
future results. As a result, the trading price of our common stock could decline, and you could
lose a part or all of your investment. You should carefully consider the risks described below with
all of the other information included in this prospectus supplement. Failure to satisfactorily
achieve any of our objectives or avoid any of the risks described below or other risks listed in
our Annual Report on Form 10-K would likely have a material adverse effect on our business and
results of operations.
Risks Related to Our Business
Our losses will continue to increase as we expand our development efforts, and our efforts may
never result in profitability.
Our cumulative losses since our inception in 1987 through June 30, 2005 were in excess of $170
million. We lost approximately $12 million in 2004, $10 million in 2003, $18 million in 2002 and
approximately $10 million in the six-month period ended June 30, 2005. We expect to continue to
incur losses in the future, particularly as we continue to invest in the development of our drug
product candidates, acquire additional drug candidates and expand the scope of our operations. We
have received FDA approval to market two generic drug products, ciprofloxacin tablets and
carboplatin injection, in the United States and recorded modest revenue in the fourth quarter of
2004, and the second quarter of 2005. However, 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.
S-4
Our business does not generate the cash needed to finance our ongoing operations and therefore, we
will need to raise additional capital.
Our current business operations do not generate sufficient operating cash to finance the
clinical development of our drug product candidates. We have historically relied primarily on
raising capital through the sale of our securities and out-licensing our drug candidates and
technology to meet our financial needs. While anticipated profits from the sale of generic drugs,
if we are successful in generating significant revenues from generics, may help defray some of the
expenses of operating our business, we believe that in order to prepare the company for continued
future drug product development and acquisition, and to capitalize on growth opportunities, we
will, for the foreseeable future, need to continue to raise funds through public or private
financings.
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 research and
drug development activities. An inability to raise additional capital would also impact our ability
to expand operations.
Clinical trials may fail to demonstrate the safety and efficacy of our proprietary drug
candidates, which could prevent or significantly delay obtaining regulatory approval.
Prior to receiving approval to commercialize any of our proprietary drug candidates, we must
demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction
of the FDA and other regulatory authorities in the United States and other countries, that each of
the products is both safe and effective. For each product candidate, we will need to demonstrate
its efficacy and monitor its safety throughout the process. If such development is unsuccessful,
our business and reputation would be harmed and our stock price would be adversely affected.
All of our product candidates are prone to the risks of failure inherent in drug development.
The results of pre-clinical studies and early-stage clinical trials of our product candidates do
not necessarily predict the results of later-stage clinical trials. Later-stage clinical trials may
fail to demonstrate that a product candidate is safe and effective despite having progressed
through initial clinical testing. Even if we believe the data collected from clinical trials of our
drug candidates are promising, such data may not be sufficient to support approval by the FDA or
any other United States or foreign regulatory approval. Pre-clinical and clinical data can be
interpreted in different ways.
Accordingly, FDA officials could interpret such data in different ways than we or our partners
do, which could delay, limit or prevent regulatory approval. The FDA, other regulatory authorities,
our institutional review boards, our contract research organization, or we may suspend or terminate
our clinical trials for our drug candidates. Any failure or significant delay in completing
clinical trials for our product candidates, or in receiving regulatory approval for the sale of any
drugs resulting from our drug candidates, may severely harm our business and reputation. Even if we
receive FDA and other regulatory approvals, our product candidates may later exhibit adverse
effects that may limit or prevent their widespread use, may cause the FDA to revoke, suspend or
limit their approval, or may force us to withdraw products derived from those candidates from the
market.
Our proprietary drug candidates, their target indications, and status of development are
summarized in the following table:
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Target Indication |
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Development Status |
Satraplatin
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Hormone Refractory Prostate Cancer
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Late Phase 3 clinical trial |
EOquin (EO9)
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Recurrent Superficial Bladder Cancer
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Late Phase 2 clinical trial |
Elsamitrucin
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Refractory non-Hodgkins Lymphoma
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Phase 2 clinical trial |
Ozarelix (formerly SPI-153)
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Hormone Dependent Prostate Cancer
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Phase 1/2 clinical trials |
Ozarelix (formerly SPI-153)
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Benign Prostatic Hypertrophy
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Phase 2 clinical trial |
Lucanthone
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Radiation Sensitizer for Brain
Tumors and Brain Metastases
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Phase 2 clinical trial |
S-5
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Drug Candidate |
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Target Indication |
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Development Status |
Satraplatin
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Non-small Cell Lung Cancer
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Phase 1/2 clinical trial |
Satraplatin
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In combination with Taxotere®
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Phase 1 clinical trial |
EO9
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Radiation Sensitizer
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Pre-clinical |
RenaZorb
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End-stage Renal Disease
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Pre-clinical |
SPI-1620
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Adjunct to Chemotherapy
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Pre-clinical |
The development of our drug candidate, satraplatin, depends on the efforts of a third party and,
therefore, its eventual success or commercial viability is largely beyond our control.
In 2002, we entered into a co-development and license agreement with GPC Biotech AG for the
development and commercialization of our lead drug candidate, satraplatin. GPC Biotech has agreed
to fully fund development and commercialization expenses for satraplatin. We do not have control
over the drug development process and therefore the success of our lead drug candidate depends upon
the efforts of GPC Biotech. GPC Biotech may not be successful in the clinical development of the
drug, the achievement of any additional milestones such as the acceptance of a New Drug
Application, or NDA, filing by the FDA, or the eventual commercialization of satraplatin.
The development of our drug candidate, ozarelix, may be adversely affected by the development
efforts of Zentaris GmbH who retained certain rights to the product.
Zentaris GmbH licensed the rights to us to develop and market ozarelix in the United States,
Canada, Mexico and India. Zentaris may conduct their own clinical trials on ozarelix for regulatory
approval in other parts of the world. We will not have control over Zentaris efforts in this area
and our own development efforts for ozarelix may be adversely impacted if their efforts are not
successful.
From time to time we may need to license proprietary technologies from third parties, which may be
difficult or expensive to obtain.
We may need to obtain licenses to patents and other proprietary rights held by third parties
to successfully develop, manufacture and market our drug products. As an example, it may be
necessary to use a third partys proprietary technology to reformulate one of our drug products in
order to improve upon the capabilities of the drug product. If we are unable to timely obtain these
licenses on reasonable terms, our ability to commercially exploit our drug products may be
inhibited or prevented.
The inability to retain and attract key personnel could significantly hinder our growth strategy
and might cause our business to fail.
Our success depends upon the contributions of our key management and scientific personnel,
especially Dr. Rajesh C. Shrotriya, our Chairman, President and Chief Executive Officer and Dr.
Luigi Lenaz, our Chief Scientific Officer. Dr. Shrotriya has been President since 2000 and Chief
Executive Officer since 2002, and has spearheaded the major changes in our business strategy and
coordinated our structural reorganization. Dr. Lenaz has been President of our Oncology Division
from November 2000 to February 2005 and Chief Scientific Officer since 2005, and has played a key
role in the identification and development of our proprietary drug candidates. The loss of the
services of Dr. Shrotriya, Dr. Lenaz or any other key personnel could delay or preclude us from
achieving our business objectives. Dr. Shrotriya has an employment agreement with us that will
expire on December 31, 2005, with automatic one-year renewals thereafter unless we, or Dr.
Shrotriya, give notice of intent not to renew at least 90 days in advance of the renewal date. Dr.
Lenaz has an employment agreement with us that will expire on July 1, 2006, with automatic one year
renewals thereafter unless we, or Dr. Lenaz, give notice of intent not to renew at least 90 days in
advance of the renewal date.
We also may need substantial additional expertise in marketing 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.
S-6
We are dependent on third parties for clinical testing, manufacturing and marketing our proposed
proprietary products. If we are not able to secure favorable arrangements with such third parties,
our business and financial condition could be harmed.
We may not conduct clinical trials ourselves, and we will not manufacture any of our proposed
proprietary products for commercial sale nor do we have the resources necessary to do so. In
addition, we currently do not have the capability to market our drug products ourselves. We intend
to contract with larger pharmaceutical companies or contract research organizations to conduct such
activities. In connection with our efforts to secure corporate partners, we may seek to retain
certain co-promotional or co-marketing rights to certain of our proprietary drug candidates, so
that we may promote our products to selected medical specialists while our corporate partner
promotes these products to the medical market generally. We may not be able to enter into any
partnering arrangements on this or any other basis. If we are not able to secure adequate
partnering arrangements, our business and financial condition could be harmed. In addition, we will
have to hire additional employees or consultants, since our current employees have limited
experience in these areas. Sufficient employees with relevant skills may not be available to us.
Any increase in the number of our employees would increase our expense level, and could have an
adverse effect on our financial position.
In addition, we, or our potential corporate partners, may not successfully introduce our
proposed proprietary products or our proposed proprietary products may not achieve acceptance by
patients, health care providers and insurance companies. Further, it is possible that we may not be
able to secure arrangements to manufacture and market our proposed proprietary products at prices
that would permit us to make a profit. To the extent that corporate partners conduct clinical
trials, we may not be able to control the design and conduct of these clinical trials.
We may have conflicts with our partners that could delay or prevent the development or
commercialization of our product candidates.
We may have conflicts with our partners, such as conflicts concerning the interpretation of
preclinical or clinical data, the achievement of milestones, payments for services, development
obligations or the ownership of intellectual property developed during our collaboration. If any
conflicts arise with any of our partners, such partner may act in a manner that is adverse to our
best interests. Any such disagreement could result in one or more of the following, each of which
could delay or prevent the development or commercialization of our product candidates, and in turn
prevent us from generating revenues:
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unwillingness on the part of a partner to pay us milestone payments or royalties 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 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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initiating of litigation by the partner to resolve the dispute; or |
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attempts by the partner to terminate the agreement. |
S-7
Our efforts to acquire or in-license and develop additional proprietary drug candidates may fail,
which would limit our ability to grow our proprietary business.
The long-term success of our strategy depends in part on obtaining drug candidates in addition
to our existing portfolio. We are actively seeking to acquire, or in-license, additional
proprietary drug candidates that demonstrate the potential to be both medically and commercially
viable. We have certain criteria that we are looking for in any drug candidate acquisition and we
may not be successful in locating and acquiring, or in-licensing, additional desirable drug
candidates on acceptable terms.
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 all of the diseases we are
pursuing, or distributing generic drug products directly competitive to the generic drugs we intend
to market and distribute. Many of these companies have substantially greater financial, research
and development, manufacturing, marketing and sales experience and resources than us. As a result,
our competitors may be more successful than us in developing their products, obtaining regulatory
approvals and marketing their products to consumers.
Competition for branded or proprietary drugs is less driven by price and is more focused on
innovation in treatment of disease, advanced drug delivery and specific clinical benefits over
competitive drug therapies. We have seven proprietary drug candidates currently under development.
We may not be successful in any or all of these studies; or if successful, and if one or more of
our proprietary drug candidates is approved by the FDA, we may encounter direct competition from
other companies who may be developing products for similar or the same indications as our drug
candidates. Companies active in the areas of oncology which is our focus include Astra Zeneca,
Amgen, Inc., Bayer AG, Eli Lilly and Co., Genentech, Inc., Novartis Pharmaceuticals Corporation,
Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., Guilford
Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-Aventis Inc., Pfizer, Inc., Chiron Corp., Genta Inc.,
Imclone Systems Incorporated, MGI Pharma, Inc., SuperGen, Inc., Roche Pharmaceuticals,
Schering-Plough, Johnson & Johnson and others who are more established and are currently marketing
products for the treatment of various forms of cancer including the forms our oncology drug
candidates target. Many of our competitors are large and well capitalized companies focusing on a
wide range of diseases and drug indications, and have substantially greater financial, research and
development, 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.
Any proprietary product for which we obtain FDA approval must compete for market acceptance
and market share. For example, cisplatin injection and carboplatin injection are the most prevalent
platinum-based derivatives used in chemotherapy and are the primary treatment for many of the
cancer types we are pursuing. Our drug candidate, satraplatin, if the FDA approves it for sale,
would likely compete against these drugs directly. Unless satraplatin is shown to have better
efficacy and is as cost effective, if not more cost effective, than cisplatin and carboplatin, it
may not gain acceptance by the medical field and therefore may never be successful commercially.
With regard to our drug product candidate, RenaZorb, under the new National Kidney Foundation
K/DOQI guidelines for treating hyperphosphatemia, non-calcium, non-aluminum binders are the
recommended first-line long-term therapy for managing high phosphate levels. Genzyme Corporations
Renagel® and Shire Pharmaceuticals Fosrenol® are the only two FDA approved non-calcium,
non-aluminum, branded pharmaceuticals specifically for the treatment of hyperphosphatemia in end
stage renal disease. We expect to compete with these products and potentially others based upon
phosphate binding capacity, patient compliance, side effects and cost. While we believe RenaZorb
has the potential to perform better than these competitors, if RenaZorb is successfully developed
and receives FDA approval, it will be a number of years after Renagel® and Fosrenol® have been FDA
approved and marketed. In addition, Genzyme and Shire may seek to modify their products or create
new therapies that could reduce or eliminate any perceived benefit we believe RenaZorb may have
over these products.
S-8
Our success in the marketing of our generic drug products will depend significantly upon our
ability to forecast market conditions that may prevail after we obtain ANDA approval and identify
generic drugs that our strategic partners and associated suppliers can produce for us
cost-effectively. In addition, we must be able to expand our marketing, selling and distribution
relationships in the United States since we currently do not have any internal distribution
capabilities and alliances with only two product distributors. Furthermore, as a new generic
competitor entering the marketplace, which is made up of many well-established companies, with
established customers as well as established sales, marketing and distribution organizations, we
may not be able to successfully compete.
Because price is the primary basis for competition among generic versions of a given drug, any
ability by our competitors to reduce production costs can provide them with a significant
competitive advantage, and our ability to compete will be largely dependent on our ability to
obtain supplies of our generic drug product from manufacturers at favorable prices. As a new
generic competitor, we will be competing against established generic companies such as Teva
Pharmaceuticals, Sandoz, Barr Laboratories, Mylan Laboratories Inc., Watson Pharmaceuticals, Inc.,
Genpharm, Dr. Reddys, Ranbaxy, American Pharmaceutical Partners, Bedford Laboratories and others.
In addition, it is anticipated that many foreign manufacturers will continue to enter the generic
market due to low barriers to entry. These companies may have greater economies of scale in the
production of their products and, in certain cases, may produce their own product supplies, such as
active pharmaceutical ingredients, or can procure product supplies on more favorable terms which
may provide significant cost and supply advantages to customers in the retail prescription market.
We expect that the generic market will be competitive and will be largely dominated by the
competitors listed above who will target many, if not all, of the same products for development as
us.
We currently have ten generic drug candidates under review at the FDA. For ciprofloxacin
tablets, our first generic product candidate filed with FDA, and for which we obtained approval in
September 2004, there are currently seventeen generic manufacturers approved to sell versions of
ciprofloxacin tablets, such as Apotex, Barr, Cobalt, Taro, Teva, West Ward, Eon Labs, Carlsbad
Technology, IVAX, Sandoz, Genpharm, Ranbaxy, Dr. Reddys, Martec and Mylan Laboratories, Inc. The
pediatric exclusivity for Diflucan®, the branded form of fluconazole, and our second generic
product filed with the FDA, expired on July 29, 2004. The market is very competitive with versions
from generic drug manufacturers such as Taro Pharmaceutical Industries, Mylan Laboratories, Inc,
Sandoz, Ranbaxy, IVAX, Genpharm, Gedeon Richter, TEVA, Torpharm, Roxane and Pliva approved by the
FDA for sale in the U.S. We have not yet obtained approval from the FDA for fluconazole tablets and
can give no assurance for when approval is likely to come, if at all. Carboplatin injection, our
third generic drug ANDA filed with FDA, and for which we obtained approval in June 2005, is the
generic equivalent of Bristol Meyers Squibbs brand Paraplatin®, for which the patent expired in
April 2004. The FDA has granted approval, following the expiration of pediatric exclusivity in
October 2004, for carboplatin injection to seven generic companies, including Pharmachemie, APP,
Bedford, Mayne, Eon and Pliva. TEVA Pharmaceuticals, through an agreement with Bristol Myers
Squibb, is currently selling carboplatin injection produced by Bristol Myers Squibb as a generic
drug. The patent for Imitrex® injection, the brand name for sumatriptan succinate injection, for
which we filed an ANDA with paragraph IV certification, has not yet expired. However, we have
initiated a challenge of the patent and are currently in litigation with GlaxoSmithKline, the
patent holder for Imitrex® injection. Based on the guidelines available to us, and our experience
with the FDA approval process, we do not anticipate receiving approval for our eight other ANDAs,
filed in 2004 and in 2005, before the first quarter of 2006, if at all, and all approvals, except
one, will come after patents and/or exclusivities expire and after some of our competitors have
already obtained approval and begun marketing.
Our proprietary drug candidates may not be more effective, safer or more cost efficient than
competing drugs and otherwise may not have any competitive advantage, which could hinder our
ability to successfully commercialize our drug candidates.
Drugs produced by other companies are currently on the market for each disease type we are
pursuing. Even if one or more of our drug candidates ultimately received FDA approval, our drug
candidates may not have better efficacy in treating the target indication than a competing drug,
may not have a more favorable side-effect profile than a competing drug, may not be more cost
efficient to manufacture or apply, or otherwise may not demonstrate a competitive advantage over
competing therapies. Accordingly, even if FDA approval is obtained for one or more of our drug
candidates, they may not gain acceptance by the medical field or become commercially successful.
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Price and other competitive pressures may make the marketing and sale of our generic drugs not
commercially feasible and not profitable.
The generic drug market in the United States is extremely competitive, characterized by many
participants and constant downward price pressure on generic drug products. Consequently, margins
are continually reduced and it is necessary to continually introduce new products to achieve and
maintain profitability. We have only obtained regulatory approval for two of our generic drug
candidates. While we have entered into agreements with third parties to manufacture the drug
products for us, given the price volatility of the generic market, we believe it is imprudent to
enter into definitive agreements on transfer prices with the manufacturers of our generic drug
product candidates prior to FDA approval, and we do not expect to do so until we receive FDA
approval and are ready to begin selling the generic drug products. Our ability to compete
effectively in the generic drug market depends largely on our ability to obtain transfer price
agreements that ensure a supply of our generic drug products at favorable prices. Even if we obtain
regulatory approval to market our generic drug candidates in the United States, we may not be able
to complete a transfer price arrangement with the manufacturers of the drug candidates that will
allow us to market the generic drug products in the United States on terms favorable to us, or at
all.
Also, if we fail to obtain approval of our ANDAs from the FDA in a timely manner, preferably
before the patent and any additional exclusivity granted by the FDA to the branded drug product
expire, our profitability will be significantly affected due to the significant price erosion
caused by the typically large number of the generic companies entering the market. The U.S. patent
and pediatric exclusivity for Cipro®, the branded form of our generic drug product ciprofloxacin
tablets, had both expired by June 2004. We received approval from the FDA of our ANDA for
ciprofloxacin tablets in September 2004, however, seventeen other companies have received FDA
approval to market generic versions of ciprofloxacin tablets, and we have observed a significant
reduction in the market price for ciprofloxacin since June 2004. The patents and all exclusivities
for our four ophthalmic products and three of our undisclosed products have previously expired (one
is still covered by a patent), and a number of other companies are currently selling their own
generic versions of the products. In addition, we did not obtain approval of our ANDAs for
fluconazole tablets and carboplatin injection prior to the expirations in July and October 2004,
respectively, of the patents and exclusivities granted by the FDA to the corresponding branded
products. Consequently, our ability to achieve a profit may be significantly harmed as we have
observed significant reductions in the market prices for these products as well. The patents for
sumatriptan succinate injection, the generic version of Imitrex®, marketed by GlaxoSmithKline, for
which we filed an ANDA with paragraph IV certification in October 2004, have not yet expired.
In addition to competitive pressures related to price, we may face opposition from the
producers of the branded versions of the generic drugs for which we obtain approval. Branded
pharmaceutical companies have aggressively sought to prevent generic competition, including the
extensive use of litigation. On February 18, 2005, GlaxoSmithKline filed suit in U.S. federal court
to prevent us from proceeding with the commercialization of our generic version of Imitrex® which
action formally initiates our challenge of one of the patents listed by GlaxoSmithKline in
connection with Imitrex® injection. For information regarding the risks of this litigation, please
see the risk factor below.
In addition, many branded pharmaceutical companies increasingly have used state and federal
legislative and regulatory means to delay generic competition. These efforts have included:
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using the citizen petition process, a process by which any person can submit a petition
to the Commissioner of the FDA to issue, amend or revoke a regulation or order or take or
refrain from taking any other administrative action, to request amendments to FDA
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seeking changes to the United States Pharmacopoeia, an organization which publishes
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attaching patent extension amendments to non-related federal legislation. |
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Also, branded pharmaceutical companies are selling generic versions of their own branded
drugs, or authorizing other companies to sell generic versions. This could hurt our ability to
capture market share and generate profits, especially if we are granted 180 days marketing
exclusivity for one of our generic drugs.
We may not be successful in expanding our generic drug distribution capabilities in the United
States, our only target market for generic drugs, which would limit our ability to grow our
generic drug business.
Many of our competitors have substantial, established direct and indirect distribution
channels. We have not yet undertaken the marketing and distribution of a generic drug product
ourselves and we currently have no direct sales and marketing organization and our limited sales
and marketing resources are devoted to establishing and enhancing our third party distribution
relationships.
We have established relationships with distributors for the distribution of ciprofloxacin
tablets and carboplatin injection; who have commenced distribution of these drugs. The long-term
success in the marketing of our generic drugs will depend in part on our drug distribution
capabilities in the U.S., our only target market for generic drugs. We may not be successful in
expanding our existing distribution channels, establishing new, additional distribution channels or
establishing a direct generic drug marketing capability sufficient to effectively and successfully
compete in the generic drug market.
We may not be successful in establishing additional generic drug supply relationships, which would
limit our ability to grow our generic drug business.
Long-term success in the marketing of generic drugs depends in part on our ability to expand
and enhance our existing relationships and establish new relationships for supplying generic drug
products. We do not presently intend to focus our research and development efforts on developing
active pharmaceutical ingredients or the dosage form for generic drugs. In addition, we currently
have no capacity to manufacture generic 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 other
companies to supply our generic drug products. We may not be successful in expanding or enhancing
our existing relationships or in securing new relationships. If we fail to expand our existing
relationships or secure new relationships, our ability to expand our generic drug business will be
harmed.
Our supply of drug products will be dependent upon the production capabilities of our supply
sources, which may limit our ability to meet demand for our products and ensure regulatory
compliance.
We have no internal manufacturing capacity for our drug product candidates, and therefore, we
have entered into agreements with third-party manufacturers to supply us with our drug products,
subject to further agreement on pricing for particular drug products. Consequently, we will be
dependent on our manufacturing partners for our supply of drug products. Some of these
manufacturing facilities are located outside the United States. The manufacture of drug products,
including the acquisition of compounds used in the manufacture of the finished drug product, may
require considerable lead times. Further, with regard to our generic drug products, sales of a new
generic drug product may be difficult to forecast. 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 market demand for a particular generic product could outstrip
the ability of our supply source to timely manufacture and deliver the product, thereby causing us
to lose sales.
Reliance on a third-party manufacturers entails risks to which we would not be subject if we
manufactured products ourselves, including reliance on the third party for regulatory compliance
and adhering to FDAs current Good Manufacturing Practices, or cGMP, requirements, the possible
breach of the manufacturing agreement by the third party because of factors beyond our control and
the possibility of termination or non-renewal of the agreement by the third party, based on its own
business priorities, at a time that is costly or inconvenient for us. Before we can obtain
marketing approval for our product candidates, our suppliers manufacturing facilities must pass an
FDA pre-approval inspection. In order to obtain approval, all of the facilitys manufacturing
methods, equipment and processes must comply with cGMP requirements. The cGMP requirements govern
all areas of record keeping, production processes and controls, personnel and quality control. Any
failure of our third-party manufacturers or us to comply with applicable regulations, including an
FDA pre-approval inspection and cGMP requirements, could
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result in sanctions being imposed on us, including fines, injunctions, civil penalties,
failure of regulatory authorities to grant marketing approval of our products, delay, suspension or
withdrawal of approvals, license revocation, seizures or recalls of product, operation restrictions
and criminal prosecutions, any of which could significantly and adversely affect our business.
GlaxoSmithKline filed suit in U.S. federal court asserting that we have infringed one of their
patent(s) for Imitrex® injection by filing our ANDA for sumatriptan injection, the generic form of
Imitrex® injection. This challenge may prevent us from commercializing sumatriptan until after the
patent has expired and may require us to incur substantial expense and the significant effort of
technical and management personnel.
On February 18, 2005, GlaxoSmithKline filed suit in U.S. federal court to prevent us from
proceeding with the commercialization of our generic form of sumatriptan injection. Since patent
litigation has been initiated, the FDA will not approve our ANDA until the earlier of 30 months
from GlaxoSmithKlines receipt of our notice of ANDA acceptance (the 30-month stay) or the issuance
of a final non-appealed, or non-appealable court decision finding the Imitrex® patent we are
currently challenging invalid, unenforceable or not infringed. If the patent is found to be
infringed by the filing of our ANDA, GlaxoSmithKline could seek an injunction to block the launch
of our generic product until the patent expires. This would prohibit us from obtaining the 180-day
marketing exclusivity afforded by the FDA to companies who are the first to file an ANDA with a
paragraph IV certification for a generic equivalent to a brand name product. We believe we are the
first to file an ANDA with a paragraph IV certification for sumatriptan injection.
Our defense against the charge of infringement by GlaxoSmithKline could require us to incur
substantial legal expense and to divert significant effort of our technical and management
personnel away from their regular activities in our business, which could substantially hinder our
ability to conduct, advance and grow our business.
Risks Related to Our Industry
Rapid technological advancement may render our drug candidates obsolete before we 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 technology. Technologies
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 technology, product or therapy that has better efficacy, a more favorable side-effect profile
or is more cost effective than one or more of our drug candidates and thereby cause our drug
candidate to become commercially obsolete. Some of our drug candidates may become obsolete before
we recover the expenses incurred in their development. As a result, such products may never become
profitable.
Competition for patients in conducting clinical trials may prevent or delay product development
and strain our limited financial resources.
Many pharmaceutical companies are conducting clinical trials in patients with the disease
indications that our drug candidates target. As a result, we must compete with them for clinical
sites, physicians and the limited number of patients who fulfill the stringent requirements for
participation in clinical trials. Also, due to the confidential nature of clinical trials, we do
not know how many of the eligible patients may be enrolled in competing studies and consequently
not available to us. 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.
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We may not be successful in obtaining regulatory approval to market and sell our proprietary or
generic drug candidates.
Before our proprietary drug candidates can be marketed and sold, regulatory approval must be
obtained from the FDA and comparable foreign regulatory agencies. We must demonstrate to the FDA
and other regulatory authorities in the United States and abroad that our product candidates
satisfy rigorous standards of safety and efficacy. We will need to conduct significant additional
research, pre-clinical testing and clinical testing, before we can file applications with the FDA
for approval of our product candidates. The process of obtaining FDA and other regulatory approvals
is time consuming, expensive, and difficult to design and implement. The review and approval, or
denial, process for an application can take years. The FDA, or comparable foreign regulatory
agencies, may not timely, or ever, approve an application. Among the many possibilities, the FDA
may require substantial additional testing or clinical trials or find our drug candidate is not
sufficiently safe or effective in treating the targeted disease. This could result in the denial or
delay of product approval. Our product development costs will increase if we experience delays in
testing or approvals. Further, a competitor may develop a competing drug or therapy that impairs or
eliminates the commercial feasibility of our drug candidates.
In order to obtain approval for our generic drug candidates, we will need to scientifically
demonstrate that our drug product is safe and bioequivalent to the innovator drug. Bioequivalence
may be demonstrated by comparing the generic drug candidate to the innovator drug product in dosage
form, strength, route of administration, quality, performance characteristics and intended use. We
plan to use our managements experience with the regulatory approval process in the United States
to prepare, file and prosecute appropriate Abbreviated New Drug Applications, or ANDAs, for our
current and future generic drug candidates. Since 2003 we have filed twelve ANDAs with the FDA. In
September 2004, we received approval from the FDA to market ciprofloxacin tablets in the United
States and in June 2005 we received approval from the FDA to market carboplatin injection in the
United States. We intend to file additional ANDAs in the foreseeable future. The FDA may not agree
that our safety and bioequivalence studies provide sufficient support for approval. This could
result in denial or delay of FDA approval of our generic products. Generic drugs generally have a
relatively short window in which they can be profitable before other manufacturers introduce
competing products that impose downward pressure on prices and reduce market share for other
versions of the generic drug. Consequently, delays in obtaining FDA approval may also significantly
impair our ability to compete.
Our failure to comply with extensive governmental regulation to which we are subject may delay or
prevent approval of our product candidates and may subject us to penalties.
The FDA and comparable agencies in foreign countries impose many requirements on the
introduction of new drugs through lengthy and detailed clinical testing and data collection
procedures, and other costly and time consuming compliance procedures. These requirements apply to
every stage of the clinical trial process and make it difficult to estimate when any of our drug
candidates will be available commercially, if at all. While we believe that we are currently in
compliance with applicable FDA regulations, if partners, our contract research organizations, or we
fail to comply with the regulations applicable to our clinical testing, the FDA may delay, suspend
or cancel our clinical trials, or the FDA might not accept the test results. The FDA, an
institutional review board at our clinical trial sites, our third-party investigators, any
comparable regulatory agency in another country, or we, may suspend clinical trials at any time if
the trials expose subjects participating in such trials to unacceptable health risks. Further,
human clinical testing may not show any current or future product candidate to be safe and
effective to the satisfaction of the FDA or comparable regulatory agencies or the data derived from
the clinical tests may be unsuitable for submission to the FDA or other regulatory agencies.
Once we submit a drug candidate for commercial sale approval, the FDA or other regulatory
agencies may not issue their approvals on a timely basis, if at all. If we are delayed or fail to
obtain these approvals, our business and prospects may be significantly damaged. Even if we obtain
regulatory approval for our product candidates, we, our partners, our manufacturers, and other
contract entities will continue to be subject to extensive requirements by a number of national,
foreign, state and local agencies. These regulations will impact many aspects of our operations,
including testing, research and development, manufacturing, safety, effectiveness, labeling,
storage, quality control, adverse event reporting, record keeping, approval, advertising and
promotion of our future products. Failure to comply with applicable regulatory requirements could,
among other things, result in:
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fines; |
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changes in advertising; |
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revocation or suspension of regulatory approvals of products; |
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product recalls or seizures; |
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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 later discovery of previously unknown problems with our products may result in
restrictions of the product candidate, including withdrawal from manufacture. In addition, the FDA
may revisit and change its prior determinations with regard to the safety and efficacy of our
future products. If the FDAs position changes, we may be required to change our labeling or to
cease manufacture and marketing of the challenged products. Even prior to any formal regulatory
action, we could voluntarily decide to cease the distribution and sale or recall any of our future
products if concerns about their safety or effectiveness develop.
In their regulation of advertising, the FDA and the Federal Trade Commission from time to time
issue correspondence alleging that some advertising or promotional practices are false, misleading
or deceptive. The FDA has the power to impose a wide array of sanctions on companies for such
advertising practices, and the receipt of correspondence from the FDA alleging these practices
could result in any of the following:
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incurring substantial expenses, including fines, penalties, legal fees and costs to
comply with the FDAs requirements; |
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changes in the methods of marketing and selling products; |
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taking FDA-mandated corrective action, which may include placing advertisements or
sending letters to physicians, rescinding previous advertisements or promotions; and |
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disruption in the distribution of products and loss of sales until compliance with the
FDAs position is obtained. |
If we were to become subject to any of the above requirements, it could be damaging to our
reputation, and our business condition could be adversely affected.
Physicians may prescribe pharmaceutical products for uses that are not described in a
products labeling or differ from those tested by us and approved by the FDA. While such
off-label uses are common and the FDA does not regulate physicians choice of treatments, the FDA
does restrict a manufacturers communications on the subject of off-label use. Companies cannot
actively promote FDA-approved pharmaceutical products for off-label uses, but they may disseminate
to physicians articles published in peer-reviewed journals. If our promotional activities fail to
comply with the FDAs regulations or guidelines, we may be subject to warnings from, or enforcement
action by, the FDA.
Legislative or regulatory reform of the healthcare system and pharmaceutical industry may hurt our
ability to sell our products profitably or at all.
In both the United States and certain foreign jurisdictions, there have been and may continue
to be a number of legislative and regulatory proposals to change the healthcare system and
pharmaceutical industry in ways that could impact upon our ability to sell our products profitably.
For example, sales of our products will depend in part on the availability of reimbursement from
third-party payers such as government health administration authorities, private
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health insurers, health maintenance organizations including pharmacy benefit managers and
other health care-related organizations. Both the federal and state governments in the United
States and foreign governments continue to propose and pass new legislation, rules and regulations
designed to contain or reduce the cost of health care. As an example, the Medicare Prescription
Drug, Improvement and Modernization Act of 2003, or the Medicare Modernization Act, was recently
enacted. This legislation provides a new Medicare prescription drug benefit beginning in 2006 and
mandates other reforms. Also, the passage of the Medicare Modernization Act reduces reimbursement
for certain drugs used in the treatment of cancer. Although we cannot predict the full effects on
our business of the implementation of this new legislation, it is possible that the new benefit,
which will be managed by private health insurers, pharmacy benefit managers and other managed care
organizations, will 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 also possible that other proposals will be adopted. As a result of the new Medicare
prescription drug benefit, or any other proposals, we may determine to change our current manner of
operation, which could harm our ability to operate our business efficiently. Existing regulations
that affect the price of pharmaceutical and other medical products may also change before any of
our products are approved for marketing. Cost control initiatives could decrease the price that we
receive for any of our products we are developing. In addition, third-party payers are increasingly
challenging the price and cost-effectiveness of medical products and services. Significant
uncertainty exists as to the reimbursement status of newly approved pharmaceutical products. Our
products may not be considered cost effective, or adequate third-party reimbursement may not be
available to enable us to maintain price levels sufficient to realize a return on our investments.
In addition, new court decisions, FDA interpretations, and legislative changes have modified
the rules governing eligibility for and the timing of 180-day market exclusivity periods, a period
of marketing exclusivity that the FDA may grant to an ANDA applicant who is the first to file a
legal challenge to patents of branded drugs. We believe we were the first to file an ANDA for
sumatriptan succinate injection, the generic form of GlaxoSmithKlines Imitrex ® injection, and are
currently in litigation with GlaxoSmithKline regarding the patent that covers this product.
However, it is difficult to predict the effects such changes may have on our business or our
current case. Any changes in FDA regulations, procedures, or interpretations may make ANDA
approvals of generic drugs more difficult or otherwise limit the benefits available to us through
the granting of 180-day marketing exclusivity. If we are not able to exploit the 180-day
exclusivity period for our sumatriptan succinate injection ANDA or one of our generic product
candidates that we were first to file, for any reason, our product may not gain market share, which
could materially adversely affect our results of operations.
As part of the Medicare Modernization Act, companies are now required to file with the Federal
Trade Commission and the Department of Justice certain types of agreements entered into between
branded and generic pharmaceutical companies related to the manufacture, marketing and sale of
generic versions of branded drugs. This new requirement could affect the manner in which generic
drug manufacturers resolve intellectual property litigation and other disputes with branded
pharmaceutical companies, and could result generally in an increase in private-party litigation
against pharmaceutical companies. The impact of this new requirement, and the potential
private-party lawsuits associated with arrangements between brand name and generic drug
manufacturers, is uncertain and could adversely affect our business.
Additional government regulations, legislation, or policies may be enacted which could prevent
or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or
extent of adverse government action that may arise from future legislation or administrative
action, either in the United States or abroad. If we are not able to maintain regulatory
compliance, we might not be permitted to market our products and our business could suffer.
Our corporate compliance program may not ensure that we are in compliance with all applicable
fraud and abuse laws and regulations, and a failure to comply with such regulations or prevail
in litigation related to noncompliance could harm our business.
Pharmaceutical and biotechnology companies have faced lawsuits and investigations pertaining
to violations of health care fraud and abuse laws, such as the federal false claims act, the
federal anti-kickback statute, and other state and federal laws and regulations. While we have
developed and implemented a corporate compliance program
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based upon what we believe are the relevant current best practices, we cannot guarantee that
this program will protect us from future lawsuits or investigations. If any such actions are
instituted against us, and we are not successful in defending ourselves or asserting our rights,
those actions could have a significant impact on our business, including the imposition of
significant fines or other sanctions.
If we are unable to adequately protect our technology or enforce our patent rights, our business
could suffer.
Our success with proprietary products that we develop will depend, in part, on our ability to
obtain and maintain patent protection for these products. We currently have a number of U.S. and
foreign patents issued and pending, however, we primarily rely on patent rights licensed from
others. These patents generally give us the right and/or obligation to maintain and enforce the
subject patents. We cannot be sure that we will receive patents for any of our pending patent
applications or any patent applications we may file in the future. If our pending and future patent
applications are not approved or, if approved, if such patents and the patents we have licensed are
not upheld in a court of law, our ability to competitively exploit our proprietary products would
be substantially harmed. Also, such patents may or may not provide competitive advantages for their
respective products or they may be challenged or circumvented by our competitors, in which case our
ability to commercially exploit these products may be diminished.
We also rely on trade secret protection and contractual protections for our unpatented,
confidential and proprietary technology. Trade secrets are difficult to protect. While we enter
into proprietary information agreements with our employees, consultants and others, these
agreements may not successfully protect our trade secrets or other confidential and proprietary
information. It is possible that these agreements will be breached, or that they will not be
enforceable in every instance, and that we will not have adequate remedies for any such breach. It
is also possible that our trade secrets will become known or independently developed by our
competitors.
If we are unable to adequately protect our technology, trade secrets or proprietary know-how,
or enforce our patents, our business, financial condition and prospects could suffer.
Intellectual property rights are complex and uncertain and therefore may subject us to infringement claims.
The patent positions related to our proprietary and generic drug candidates are inherently
uncertain and involve complex legal and factual issues. Although we are not aware of any
infringement by any of our drug candidates on the rights of any third party, there may be third
party patents or other intellectual property rights relevant to our drug candidates of which we are
not aware. Third parties may assert patent or other intellectual property infringement claims
against us with respect to our proprietary drug candidates or our generic drug products. This could
draw us into costly litigation as well as result in the loss of our use of the intellectual
property that is critical to our business strategy.
Intellectual property litigation is increasingly common and increasingly expensive and may result
in restrictions on our business and substantial costs, even if we prevail.
Patent and other intellectual property litigation is becoming more common in the
pharmaceutical industry. Litigation is sometimes necessary to defend against or assert claims of
infringement, to enforce our patent rights, including those we have licensed from others, to
protect trade secrets or to determine the scope and validity of proprietary rights of third
parties. Other than the lawsuit filed against us by GlaxoSmithKline related to our ANDA for
sumatriptan injection, currently no third party has asserted 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
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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
Patent and Trademark Office to determine priority of invention, which could result in substantial
costs, even if we ultimately prevail. Results of interference proceedings are highly unpredictable
and may result in us having to try to obtain licenses in order to continue to develop or market
certain of our drug candidates.
We may be subject to product liability claims, and may not have sufficient product liability
insurance to cover any such claims, which may expose us to substantial liabilities.
We may be exposed to product liability claims from patients who participate in our clinical
trials or from consumers of our products. Although we currently carry product liability insurance
in the amount of at least $5 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.
Our research and development efforts involved and currently involves the use of hazardous
materials. We are subject to federal, state and local laws and regulations governing the storage,
use and disposal of these materials and some waste products. We believe that our safety procedures
for the storage, use and disposal of these materials comply with the standards prescribed by
federal, state and local regulations. However, we cannot completely eliminate the risk of
accidental contamination or injury from these materials. If there were to be an accident, we could
be held liable for any damages that result, which could exceed our financial resources. We
currently maintain insurance coverage for injuries resulting from the hazardous materials we use,
and for pollution clean up and removal; however, future claims may exceed the amount of our
coverage. Currently the costs of complying with federal, state and local regulations are not
significant, and consist primarily of waste disposal expenses.
Risks Related to Our Stock
There are a substantial number of shares of our common stock eligible for future sale in the
public market. The sale of these shares could cause the market price of our common stock to fall.
Any future equity issuances by us may have dilutive and other effects on our existing
stockholders.
As of June 30, 2005, there were approximately 15.3 million shares of our common stock
outstanding, and in addition, security holders held options, warrants and preferred stock which, if
exercised or converted, would obligate us to issue up to approximately 11 million additional shares
of common stock. A substantial number of those shares, when we issue them upon conversion or
exercise, will be available for immediate resale in the public market. In addition, we have filed a
shelf registration statement that allows us to sell up to $100 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 immediate resale in the market.
We may issue and sell all of these securities within two years after January 24, 2005, the date of
the effectiveness of the registration statement. If we were to sell the full $100 million available
under the registration statement as common stock at a price approximately equal to the current
market price of our common stock, we would issue approximately 20.0 million new shares of our
common stock. The market price of our common stock could fall as a result of resales of any of
these shares of common stock due to the increased number of shares available for sale in the
market.
S-17
We have financed our operations, and for the foreseeable future we expect to continue to
finance a substantial portion of our operating cash requirements, primarily by issuing and selling
our common stock or securities convertible into or exercisable for shares of our common stock. Any
issuances by us of equity securities may be at or below the prevailing market price of our common
stock and may have a dilutive impact on our other stockholders. These issuances would also cause
our net income, if any, per share to decrease or our loss per share to decrease in future periods.
As a result, the market price of our common stock could drop.
The market price and volume of our common stock fluctuate significantly and could result in
substantial losses for individual investors.
The stock market from time to time experiences significant price and volume fluctuations that
are unrelated to the operating performance of particular companies. These broad market fluctuations
may cause the market price and volume of our common stock to decrease. In addition, the market
price and volume of our common stock is highly volatile. Factors that may cause the market price
and volume of our common stock to decrease include fluctuations in our results of operations,
timing and announcements of our technological innovations or new products or those of our
competitors, FDA and foreign regulatory actions, developments with respect to patents and
proprietary rights, public concern as to the safety of products developed by us or others, changes
in health care policy in the United States and in foreign countries, changes in stock market
analyst recommendations regarding our common stock, the pharmaceutical industry generally and
general market conditions. In addition, the market price and volume of our common stock may
decrease if our results of operations fail to meet the expectations of stock market analysts and
investors. 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 2004, the price of our common stock
ranged between $3.92 and $10.13, and the daily trading volume was as high as 1,391,800 shares and
as low as 9,900 shares. During 2005 through September 12, 2005, the price of our common stock has
ranged between $4.06 and $7.50, and the daily trading volume has been as high as 1,368,400 shares
and as low as 18,400 shares.
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, as amended, and bylaws 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; |
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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.
In December 2000, we adopted 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 20% 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 20%
or more of our outstanding common stock. These rights could delay or discourage
S-18
someone from acquiring our business, even if doing so would benefit our stockholders. We
currently have no stockholders who own 20% or more of the outstanding shares of our common stock.
We do not anticipate declaring any cash dividends on our common stock.
We have never declared or paid cash dividends on our common stock and do not plan to pay any
cash dividends in the near future. Our current policy is to retain all funds and any earnings for
use in the operation and expansion of our business
USE OF PROCEEDS
If we were to sell 6,517,691 shares of our common stock pursuant to this offering, the net
proceeds to us from this offering, before deducting the estimated placement agents fees and our
estimated offering expenses, will be approximately $35,000,000 based upon the public offering price
of $5.37 per share. Any placement agent or finder associated with this offering would be working
solely on a best efforts basis and therefore, we may not sell the entire amount of shares of our
common stock offered pursuant to this prospectus. We plan to use the net proceeds we raise for
general corporate purposes, including:
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Working capital |
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Capital expenditures |
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Research and development |
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General and administrative expenses |
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Acquisitions of rights to new products |
Net proceeds from the sale of the offered securities may be invested in cash equivalents and
other interest-bearing short-term investments for capital preservation until used for the above.
DILUTION
The net tangible book value of our common stock on June 30, 2005 was approximately
$25,196,000, or approximately $1.64 per share. Net tangible book value per share represents the
amount of our total tangible assets, less our total liabilities and the aggregate liquidation
preference of our preferred stock outstanding, divided by the total number of shares of our common
stock outstanding. Dilution in net tangible book value per share to new investors represents the
difference between the amount per share paid by purchasers of shares of our common stock in this
offering and the net tangible book value per share of our common stock immediately afterwards.
Without taking into account any other changes in net tangible book value after June 30, 2005, and
after deducting the estimated finders fees and estimated offering expenses payable by us, our net
tangible book value would have been $58,011,000, or approximately $2.65 per share. This represents
an immediate accretion in net tangible book value of approximately $1.01 per share to existing
stockholders and an immediate dilution in net tangible book value of $2.72 per share to new
investors.
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Offering price per share |
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5.37 |
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Net tangible book value per share as of June 30, 2005 |
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1.64 |
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Increase per share attributable to new investors |
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1.01 |
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As adjusted net tangible book value per share after the offering |
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2.65 |
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Decrease in net tangible book value per share to new investors |
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$ |
2.72 |
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This table excludes shares of common stock issuable upon exercise of options, warrants and
other rights, including the Warrants issued in this offering, and the effect of shares of common
stock issued, except as indicated above, since June 30, 2005.
S-19
PLAN OF DISTRIBUTION
Our common stock is traded on the Nasdaq National Market under the symbol SPPI.
This prospectus supplement relates to an offering by us on a best efforts basis of up to
6,517,691 shares of our common stock at a purchase price of $5.37 per share, and warrants to
purchase up to 3,258,845 shares of our common stock at an exercise price of $6.62 per share, to
certain individual and institutional investors for aggregate proceeds of approximately $35,000,000.
We will enter into purchase agreements directly with the investors in connection with this
offering in substantially the form included as Annex A to this prospectus supplement. Investors
participating in the offering will receive warrants to purchase one share of common stock for every
two shares of common stock purchased in the offering in substantially the form included as Annex B
to this prospectus supplement. In connection with this offering, we will pay fees or commissions
to Rodman & Renshaw, LLC (Rodman), who will be working solely on a best efforts basis.
Therefore, we may not sell the entire amount of shares of our common stock offered pursuant to this
prospectus supplement in which case our net proceeds would be reduced.
Rodman may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the
Securities Act of 1933, as amended, or the Securities Act, and any commissions received by it and
any profit realized on the resale of the securities sold by it while acting as principal might be
deemed to be underwriting discounts or commissions under the Securities Act. As underwriters,
Rodman would be required to comply with the requirements of the Securities Act and the Securities
Exchange Act of 1934, as amended, or the Exchange Act, including, without limitation, Rule
415(a)(4) under the Securities Act and Rule 10b-5 and Regulation M under the Exchange Act. These
rules and regulations may limit the timing of purchases and sales of shares of common stock and
warrants by Rodman. Under these rules and regulations, Rodman:
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may not engage in any stabilization activity in connection with our securities; and |
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may not bid for or purchase any of our securities or attempt to induce any person to
purchase any of our securities, other than as permitted under the Exchange Act, until
such Distribution Participant has completed its participation in the distribution. |
On September 14, 2005, we entered into a letter agreement with Rodman pursuant to which Rodman
shall act as a placement agent for purchasers of our securities pursuant to our existing shelf
registration statement, file no. 333-121612, for a period of 30 days. Pursuant to the agreement,
we will pay Rodman at each closing a cash fee equal to 6% of all cash proceeds received by us from
investors introduced to us by Rodman.
We have also agreed to reimburse Rodman for its expenses incurred in connection with the
offering up to the lesser of 1% of the offering proceeds or $25,000. Under no circumstances,
however, will the fee, commission or discount received by the Rodman or any other NASD member or
independent broker-dealer exceed 8% for the sale of any securities in this offering.
We have also agreed to indemnify Rodman against certain liabilities, including liabilities
under the Securities Act.
In addition, we estimate that our share of the total expenses of this offering, excluding the
finder fees and expense reimbursements, will be approximately $60,000.
DESCRIPTION OF COMMON STOCK
The following summary of terms of our common stock does not purport to be complete and is
subject to and qualified in its entirety by reference to our Charter and Bylaws, copies of which
are on file with the Commission. See Where You Can Find More Information.
We have authority to issue 50,000,000 shares of common stock, $.001 par value per share. As of
September 9, 2005, we had 15,362,574 shares of common stock outstanding, held by approximately 365
stockholders of record.
S-20
Terms
Holders of our common stock are entitled to one vote per share on all matters to be voted upon
by the stockholders. The holders of common stock are not entitled to cumulative voting rights with
respect to election of directors, and as a consequence, minority stockholders will not be able to
elect directors on the basis of their shares alone. Our Board of Directors currently consists of
five directors each of whom is elected annually.
No dividend on our common stock may be paid unless, at the time of such payment, all accrued
dividends on our Series D 8% Cumulative Convertible Voting Preferred Stock have been paid, and 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, 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, before any distribution of
our assets shall be made to or set apart for the holders of our common stock, the holders of our
Series D 8% Cumulative Convertible Voting Preferred Stock and 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 20% 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 20% 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 U.S. Stock Transfer Corporation, 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, and 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.
Certain Provisions of Delaware Law and of the Companys Charter and Bylaws
The following paragraphs summarize certain provisions of the Delaware General Corporation Law
and the Companys Charter and Bylaws. The summary does not purport to be complete and is subject to
and qualified in its entirety by reference to the DGCL and to the Companys Charter and Bylaws,
copies of which are on file with the 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.
S-21
Our Certificate of Incorporation limits the extent to which our directors are personally
liable to Spectrum and our stockholders, to the fullest extent permitted by the Delaware General
Corporation Law, or DGCL. The inclusion of this provision in our Certificate of Incorporation may
reduce the likelihood of derivative litigation against directors and may discourage or deter
stockholders or management from bringing a lawsuit against directors for breach of their duty of
care.
Our Bylaws provide that special meetings of stockholders can be called only by the Board of
Directors, the Chairman of the Board of Directors or the Chief Executive Officer. Stockholders are
not permitted to call a special meeting and cannot require the Board of Directors to call a special
meeting. There is no right of stockholders to act by written consent without a meeting, unless the
consent is unanimous. Any vacancy on the Board of Directors resulting from death, resignation,
removal or otherwise or newly created directorships may be filled only by vote of the majority of
directors then in office, or by a sole remaining director. Our Bylaws establish advance notice
procedures with respect to stockholder proposals and the nomination of candidates for election as
directors, except for nominations made by or at the direction of the board of directors or a
committee of the board. See Terms above.
We are subject to the business combination statute of the DGCL, an anti-takeover law enacted
in 1988. In general, Section 203 of the DGCL prohibits a publicly-held Delaware corporation from
engaging in a business combination with an interested stockholder, for a period of three years
after the date of the transaction in which a person became an interested stockholder, unless:
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prior to such date the board of directors of the corporation approved
either the business combination or the transaction which resulted in
the stockholder becoming an interested stockholder, |
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upon consummation of the transaction which resulted in the stockholder
becoming an interested stockholder, the interested stockholder
owned at least 85% of the voting stock of the corporation outstanding
at the time the transaction commenced, excluding for purposes of
determining the number of shares outstanding those shares owned (1) by
persons who are directors and also officers and (2) employee stock
plans in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan will
be tendered in a tender or exchange offer, or |
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at or subsequent to such time the business combination is approved
by the board of directors and authorized at an annual or special
meeting of stockholders, and not by written consent, by the
affirmative vote of a least 66 2/3% of the outstanding voting stock
which is not owned by the interested stockholder. |
A business combination includes mergers, stock or asset sales and other transactions
resulting in a financial benefit to the interested stockholders. An interested stockholder is a
person who, together with affiliates and associates, owns (or within three years, did own) 15% or
more of the corporations voting stock. Although Section 203 permits us to elect not to be governed
by its provisions, we have not made this election. As a result of the application of Section 203,
potential acquirers of Spectrum may be discouraged from attempting to effect an acquisition
transaction with us, thereby possibly depriving holders of our securities of certain opportunities
to sell or otherwise dispose of such securities at above-market prices pursuant to such
transactions.
Transfer Agent and Registrar
The transfer agent and registrar for the common stock is U.S. Stock Transfer Corporation.
DESCRIPTION OF COMMON STOCK WARRANTS
The following summary of term of our common stock warrants does not purport to be complete and
is subject to and qualified in its entirety by reference to our Charter and Bylaws, copies of which
are on file with the Commission. See Where You Can Find More Information.
As of September 13, 2005, we had outstanding warrants to purchase up to 6.6 million shares of
our common stock, held of record by approximately 89 holders, of which warrants to purchase up to 5.3 million shares
S-22
of common stock were immediately 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 through April 2009.
This prospectus supplement relates to the issuance of warrants to purchase up to 3,258,845
shares of our common stock and the issuance of the shares of common stock upon exercise of the
warrants. The warrants will have an exercise price of $6.62 per share and will be immediately
exercisable. The warrants will expire if not exercised within six years of their date of issuance.
The shares our common stock underlying the warrants, when issued upon exercise of the warrants,
will be fully paid and nonassessable, and we will pay any transfer tax incurred as a result of the
issuance of the underlying common stock except for any tax payable in respect of any transfer in a
name other than the holders.
The warrants contain provisions that protect the holders against dilution by adjustment of the
exercise price and the number of shares issuable. Such adjustments will occur in the event, among
others, of a:
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merger, |
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stock split or reverse stock split, |
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stock dividend, |
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sale or transfer of all or substantially all of our assets, or |
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recapitalization. |
In the event of a merger, consolidation, capital reorganization, recapitalization or sale or
transfer of all or substantially all of our assets in which adequate provision is not made for the
holder of the warrants to receive upon exercise of the warrants the shares of stock, securities or
assets as would have been issuable or payable pursuant to such transaction with respect to or in
exchange for the number of shares of our common stock as to which the warrant is then being
exercised, then the holder will be entitled to receive a cash payment in return for the
cancellation of the warrant based on a Black-Scholes valuation of the warrant determined as
provided in the appendix to the warrant.
We are not required to issue fractional shares upon the exercise of the warrants. The holders
of the warrants will not possess any rights as shareholders of Spectrum Pharmaceuticals until such
holders exercise the warrants.
Each warrant may be exercised upon surrender of the warrant on or before the expiration date
of the warrant at our offices with the Form of Election to Purchase attached to the warrant
completed and executed as indicated, accompany by payment of the exercise price in immediately
available funds, by certified or bank draft or by wire transfer to an account designated by us, for
the number of shares with respect to which the warrant is being exercised. We will promptly
deliver certificates representing the purchased shares to the registered holder of the warrant,
registered in the name specified in the Form of Election to Purchase. If at the time of exercise
there is not then effective a registration statement covering such exercise, and such exercise is
at least one year after the date of issuance of the warrants, the warrants may be exchanged for a
number of shares of our common stock equal to the number of shares as to which the warrant is then
being exercised, less a number of shares having an aggregate current market price equal to the
aggregate exercise price due for such exercise. There is no minimum or maximum amount which may be
exercised at any one time, however the warrants may not be exercised to the extent that the holder
would be a beneficial owner of more than 4.99% of our common stock following such exercise.
The warrants may not be transferred or assigned without first being offered to us for
repurchase except in certain limited circumstances. We shall register the transfer or assignment
of any portion of a warrant in the warrant register upon surrender of the warrant at our offices
with the Form of Assignment attached to the warrant completed and executed as indicated. Upon any
such transfer or assignment, a new warrant evidencing the portion transferred shall be issued to
the transferee, and a new warrant evidencing the remaining portion not transferred shall be issued
to the transferor. Each warrant is exchangeable, upon surrender of the warrant at our offices, for
one or more new warrants, evidencing in the aggregate the right to purchase the number of shares of our common
stock which may then be purchased pursuant to the warrant.
S-23
For the life of the warrants, the holders of the warrants have the opportunity to profit from
a rise in the market price of our common stock without assuming the risk of ownership of the shares
of the underlying common stock. The warrant holders may be expected to exercise the warrants at a
time when we would, in all likelihood, be able to obtain any needed capital by an offering of our
common stock on terms more favorable than those provided for by the warrants. Furthermore, the
terms on which we obtain additional capital during the life of the warrants may be adversely
affected.
The warrants will not be listed on any exchange or quotation system. We will act as warrant
agent under the warrants.
VALIDITY OF COMMON STOCK
Latham & Watkins LLP, Costa Mesa, California, will pass on the validity of the common stock
offered by this prospectus supplement.
EXPERTS
The consolidated financial statements of the Company as of December 31, 2004 and December 31,
2003 and for each of the three years in the period ended December 31, 2004, incorporated by
reference in this registration statement have been audited by Kelly & Company, independent
certified public accountants, as indicated in their report with respect thereto, and are included
herein in reliance upon the authority of said firm as experts in giving said report.
LIMITATION ON LIABILITY AND DISCLOSURE OF SEC POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Our bylaws provide for indemnification of our directors and officers to the fullest extent
permitted by law. Insofar as indemnification for liabilities under the Securities Act may be
permitted to directors, officers or controlling persons of the Company pursuant to the Companys
Certificate of Incorporation, as amended, bylaws and the Delaware General Corporation Law, the
Company has been informed that in the opinion of the SEC such indemnification is against public
policy as expressed in such Act and is therefore unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other information with the
SEC. You may read and copy any document we file at the SECs public reference room at 450 Fifth
Street, N.W., Washington, D.C., 20549. Please call the SEC at 1-800-SEC-0330 for further
information on the public reference room. Our SEC filings are also available to the public at the
SECs web site at http://www.sec.gov.
The SEC allows us to incorporate by reference the information we file with them which means
that we can disclose important information to you by referring you to those documents instead of
having to repeat the information in this prospectus supplement. The information incorporated by
reference is considered to be part of this prospectus supplement, and later information that we
file with the SEC will automatically update and supersede this information. We incorporate by
reference the documents listed below and any future filings made with the SEC under Sections 13(a),
13(c), 14, or 15(d) of the Securities Exchange Act of 1934 until the offering is terminated:
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Our annual report on Form 10-K for the fiscal year ended December 31, 2004, filed on
March 15, 2005; |
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Our quarterly reports on Form 10-Q for the quarter ended March 31, 2005 and June 30,
2005, filed on May 10, 2005 and August 9, 2005, respectively; |
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Our current reports on Form 8-K filed on January 11, 2005, January 25, 2005,
February 3, 2005, February 25, 2005, April 19, 2005, May 10, 2005, May 20, 2005, June
16, 2005 and September 14, 2005; |
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Our definitive proxy statement filed on June 10, 2005, pursuant to Section 14 of the
Exchange Act in connection with our 2005 Annual Meeting of Stockholders; |
S-24
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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. |
You can request a copy of these filings, at no cost, by writing or telephoning us at the
following address:
Spectrum Pharmaceuticals, Inc.
Attn: Investor Relations
157 Technology Drive
Irvine, California 92618
(949) 788-6700
You should rely only on the information contained in this prospectus supplement, the
accompanying prospectus, and the documents incorporated by reference herein and therein. We have
not authorized anyone else to provide you with different information. We will not make an offer of
these shares in any state where the offer is not permitted. You should not assume that the
information in this prospectus supplement, the accompanying prospectus or any other supplement or
in the documents incorporated by reference herein and therein is accurate on any date other than
the date on the front of those documents.
This prospectus supplement, the accompanying prospectus and any documents incorporated by
reference herein and therein, are part of a registration statement we filed with the SEC
(Registration No. 333-121612). The registration statement and the documents incorporated by
reference into it and this prospectus supplement and the accompanying prospectus contain more
information about the shares sold by us pursuant to this prospectus supplement. Because
information about contracts referred to in this prospectus supplement and the accompanying
prospectus is not always complete, you should read the full contracts which are incorporated by
reference in the registration statement, this prospectus supplement and the accompanying
prospectus. You may read and copy the full registration statement and the documents incorporated
by reference into it at the SECs public reference rooms or their web site.
S-25
ANNEX A
SECURITIES PURCHASE AGREEMENT
This Securities Purchase Agreement (this Agreement) is dated September 14, 2005 by and
between (Purchaser) and Spectrum Pharmaceuticals, Inc. (Company). The
parties hereto agree as follows:
The Purchaser shall buy and the Company agrees to sell shares (Shares) of the
Companys Common Stock (the Common Stock) at a price of $5.37 per share for a total amount of
$ . The Purchaser shall also receive a warrant, in the form of Exhibit A
attached hereto, to purchase up to a number of shares equal to 50% of the Shares (or
Warrant Shares), at an exercise price equal to $6.62 per Warrant Share and a term of exercise equal
to six years from the date of issuance (the Warrant). The Shares, the Warrant and the Warrant
Shares (collectively, the Securities) have been registered on a registration statement on Form
S-3, File No. 333-121612 (the Registration Statement), which has been declared effective by the
Securities and Exchange Commission, and remains effective as of the date hereof. A final
prospectus supplement will be delivered prior to funding regarding the issuance and sale of the
Shares and Warrant, a copy of which is attached hereto as Exhibit B (the Prospectus
Supplement). The Shares, Warrant and Warrant Shares when issued, will be free of restrictive
legends and are free of any resale restrictions.
Execution and delivery of this Agreement by the Purchaser shall constitute a binding offer to
purchase the Shares and the Warrants at the Purchase Price, subject only to acceptance and delivery
of this Agreement by the Company, together with delivery of the Prospectus Supplement to the
Purchaser. The Shares, the Warrants, and the Warrant Shares when issued, will be free of
restrictive legends and are free of any resale restrictions.
The Purchaser represents and warrants to the Company:
(a) The Purchaser is a corporation or other legal entity duly organized, validly
existing and in good standing under the laws of .
(b) The Purchaser has the requisite corporate (or other entity) power and authority to
enter into and perform this Agreement and to purchase the Shares in accordance with the
terms hereof. This Agreement constitutes a valid and binding obligation of the Purchaser
enforceable against the Purchaser in accordance with its terms, except as such
enforceability may be limited by applicable bankruptcy, insolvency or similar laws relating
to, or affecting generally, the enforcement of creditors rights and remedies or by other
equitable principles of general application.
(c) In making its investment decision in this offering, the Purchaser and its advisors,
if any, have relied solely on the Companys public filings as filed with the Securities and
Exchange Commission, including the base prospectus filed as part of the Registration
Statement when it was declared effective, and all documents incorporated therein by
reference.
(d) Purchaser is not a registered broker-dealer or an affiliate of a registered
broker-dealer.
(e) Purchaser represents, warrants and covenants that neither Purchaser nor any
affiliate of such Purchaser which (i) had knowledge of the transactions contemplated hereby,
(ii) has or shares discretion relating to such Purchasers investments or trading or
information concerning such Purchasers investments, including in respect of the Securities;
or (iii) is subject to such Purchasers review or input concerning such affiliates
investments or trading, has or will, directly or indirectly, during the period beginning on
the date on which the Company or a financial advisor to the Company, first contacted such
Purchaser regarding the transactions contemplated by this Agreement and ending on the
Closing Date,
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engage in: (1) any short sales (as such term is defined in Rule 200 promulgated under
the Securities Exchange Act of 1934, as amended (the Exchange Act)) of the Common Stock,
including, without limitation, the maintaining of any short position with respect to,
establishing or maintaining a put equivalent position (within the meaning of Rule 16a-1(h)
under the Exchange Act) with respect to, entering into any swap, derivative transaction or
other arrangement (whether any such transaction is to be settled by delivery of Common
Stock, other securities, cash or other consideration) that transfers to another, in whole or
in part, any economic consequences or ownership, or otherwise dispose of, any Common Stock
by Purchaser; or (2) any hedging transaction which establishes a net short position with
respect to the Common Stock.
The closing is expected to occur on or about September 14, 2005 (the Closing Date).
The Purchaser and the Company acknowledge and agree that the Company will not issue additional
shares of its Common Stock with respect to this transaction under circumstances that would require
the approval of its stockholders pursuant to applicable Nasdaq rules without obtaining such
approval.
Neither the Company nor any of its officers or agents shall disclose any material non-public
information about the Company to the Purchaser and neither the Purchaser nor any of its affiliates,
officers or agents will solicit any material non-public information from the Company in connection
with the offer and sale of the Shares by the Company to the Purchaser.
The Purchaser shall wire the purchase amount to the Company to the account set forth below.
Company Wire Transfer Instructions:
Bank
Address
ABA#
The Company shall cause its transfer agent to transmit the Shares electronically to the
Purchaser by crediting the account set forth on the signature page through the Deposit Withdrawal
Agent Commission system, and shall deliver the Warrant certificates to the address specified by the
Purchaser on the signature pages hereto.
All communications hereunder shall be in writing and shall be deemed to have been given on the
date delivered by hand, sent by facsimile transmission, or mailed certified mail, return receipt
requested, if to the Purchaser, to the address set forth on the signature page of this Agreement,
and if to the Company, to 157 Technology Drive, Irvine, California, 92618, Facsimile (949)
788-6706, Attention: Chief Financial Officer Either party to this Agreement may change such
address for notices by sending to the other party written notice of a new address for such purpose.
This Agreement shall be governed and construed in accordance with the laws of the State of New
York, without giving effect to conflict of law principles. Each of the Company and the Purchaser
irrevocably submits to the jurisdiction of the United States District Court sitting in New York,
New York for the purposes of any suit, action or proceeding arising out of or relating to this
Agreement and hereby waives any claim that it is not personally subject to the jurisdiction of such
court, that the suit, action or proceeding is brought in an inconvenient forum or that the venue of
the suit, action or proceeding is improper.
Following the date hereof, the Company shall promptly issue a press release disclosing the
material terms of the transaction contemplated hereby and shall file the Prospectus Supplement with
the SEC within the time required by Rule 424.
The Purchaser may not assign or otherwise transfer this Agreement or its rights hereunder
without the consent of the Company.
This Agreement may be executed in one or more counterparts, all of which taken together shall
constitute one and the same instrument.
[Remainder of this page intentionally left blank.]
S-27
AGREED AND ACCEPTED, as of the date first written above:
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Spectrum Pharmaceuticals, Inc. |
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By: |
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Name: |
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Title: |
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PURCHASER: |
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By: |
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Name: |
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Title: |
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Address: |
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Facsimile No.: |
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Purchaser DWAC Instructions: |
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DTC# |
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Account # |
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Reference # |
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Address for delivery of Warrants (if different): |
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EIN: |
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S-28
ANNEX B
Warrant No.
COMMON STOCK PURCHASE WARRANT
To Purchase Shares of Common Stock of
SPECTRUM PHARMACEUTICALS, INC.
THIS COMMON STOCK PURCHASE WARRANT (the Warrant) certifies that, for value received,
(the Holder), is entitled to subscribe for and purchase from Spectrum
Pharmaceuticals, Inc., a Delaware corporation (the Company), upon the terms and subject
to the limitations on exercise and the conditions hereinafter set forth, at any time on or after
the date hereof (the Initial Exercise Date), and on or prior to the close of business on
September 14, 2011 (the Expiration Date) but not thereafter, up to ___shares (the
Warrant Shares) of Common Stock, par value $6.62 per share, of the Company (the
Common Stock). The purchase price of one share of Common Stock under this Warrant shall
be equal to the Exercise Price, as defined in Section 2(b).
Section 1. Definitions. Capitalized terms used and not otherwise
defined herein shall have the meanings set forth in that certain Securities Purchase
Agreement (the Purchase Agreement), dated September 14, 2005, among the Company
and the purchasers signatory thereto.
Section 2. Exercise.
a) Exercise of Warrant. Exercise of the purchase rights represented by this
Warrant may be made at any time or times on or after the Initial Exercise Date until
5:00 P.M. (New York City time), on the Expiration Date by delivery to the Company of
a duly executed facsimile copy of the Notice of Exercise Form annexed hereto (or
such other office or agency of the Company as it may designate by notice in writing
to the registered Holder at the address of such Holder appearing on the books of the
Company); provided, however, within 5 Trading Days (a day on which
the Nasdaq Stock Market is open for ordinary trading) of the date said Notice of
Exercise is delivered to the Company, the Holder shall have surrendered this Warrant
to the Company and the Company shall have received payment of the aggregate Exercise
Price of the shares thereby purchased by wire transfer or cashiers check drawn on a
United States bank.
b) Exercise Price. The exercise price of the Common Stock under this
Warrant shall be $6.62, subject to adjustment under Section 3 hereof (the
Exercise Price).
c) Net Exchange. If at the time of exercise more than one year from the date
of issuance of this Warrant there is no effective registration statement permitting the sale
of the Warrant Shares by the Company to the Holder, then this Warrant may also be
exchange d at such time fo r the number of Warrant Shares equal to the quotient
obtained by dividing [(A-B) (X)] by (A), where:
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= the closing bid price on the Trading Day immediately
preceding the date of such election as reported by Bloomberg, L.P.; |
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= the Exercise Price of this Warrant, as adjusted; and |
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= the number of Warrant Shares issuable upon exercise of this
Warrant in accordance with the terms of this Warrant by means of a cash
exercise rather than a net exchange. |
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Exercise Limitations. |
i. Holders Restrictions. The Holder shall not have the right
to exercise any portion of this Warrant to the extent that after giving
effect to such issuance after
S-29
exercise, the Holder (together with the Holders affiliates), as set
forth on the applicable Notice of Exercise, would beneficially own in excess
of 4.99% of the number of shares of the Common Stock outstanding immediately
after giving effect to such issuance (such limitation being referred to
herein as the Beneficial Ownership Cap). For purposes of the
Beneficial Ownership Cap, the number of shares of Common Stock beneficially
owned by the Holder and its affiliates shall include the number of shares of
Common Stock issuable upon exercise of this Warrant with respect to which
the determination of such sentence is being made, but shall exclude the
number of shares of Common Stock which would be issuable upon (A) exercise
of the remaining, nonexercised portion of this Warrant beneficially owned by
the Holder or any of its affiliates and (B) exercise or conversion of the
unexercised or nonconverted portion of any other securities of the Company
(including, without limitation, any other Shares or Warrants) subject to a
limitation on conversion or exercise analogous to the Beneficial Ownership
Cap beneficially owned by the Holder or any of its affiliates. Except as
set forth in the preceding sentence, for purposes of this Section 2(c),
beneficial ownership shall be calculated in accordance with Section 13(d) of
the Exchange Act, it being acknowledged by Holder that the Company is not
representing to Holder that such calculation is in compliance with Section
13(d) of the Exchange Act and Holder is solely responsible for any schedules
required to be filed in accordance therewith. To the extent that the
Beneficial Ownership Cap applies, the determination of whether this Warrant
is exercisable (in relation to other securities owned by the Holder) and of
which a portion of this Warrant is exercisable shall be in the sole
discretion of such Holder, and the submission of a Notice of Exercise shall
be deemed to be such Holders representation to the Company that its Warrant
is exercisable (in relation to other securities owned by such Holder) and of
which portion of this Warrant is exercisable, in each case subject to such
aggregate percentage limitation, and the Company shall have no obligation to
verify or confirm the accuracy of such determination. For purposes of this
Section 2(c), in determining the number of outstanding shares of Common
Stock, the Holder may rely on the number of outstanding shares of Common
Stock as reflected in (x) the Companys most recent Form 10-Q or Form 10-K,
as the case may be, (y) a more recent public announcement by the Company or
(z) any other notice by the Company or the Companys Transfer Agent setting
forth the number of shares of Common Stock outstanding. Upon the written or
oral request of the Holder, the Company shall within two Trading Days
confirm orally and in writing to the Holder the number of shares of Common
Stock then outstanding. In any case, the number of outstanding shares of
Common Stock shall be determined after giving effect to the conversion or
exercise of securities of the Company, including this Warrant, by the Holder
or its affiliates since the date as of which such number of outstanding
shares of Common Stock was reported.
e) Mechanics of Exercise.
i. Authorization of Warrant Shares. The Company covenants that
all Warrant Shares which may be issued upon the exercise of the purchase
rights represented by this Warrant will, upon exercise of the purchase
rights represented by this Warrant, be duly authorized, validly issued,
fully paid and nonassessable and free from all taxes, liens and charges in
respect of the issue thereof (other than taxes in respect of any transfer
occurring contemporaneously with such issue).
ii. Delivery of Certificates Upon Exercise. Certificates for
shares purchased hereunder shall be transmitted by the transfer agent of the
Company to the Holder by crediting the account of the Holders prime broker
with the Depository Trust Company through its Deposit Withdrawal Agent
Commission (DWAC) system if the Company is a participant in such
system, and otherwise by physical delivery to the address specified by the
Holder in the Notice of Exercise within 3 Trading Days from the delivery to
the Company of the Notice of Exercise Form, surrender of this Warrant and
payment of the aggregate Exercise Price as set forth above (Warrant
Share Delivery Date). This
S-30
Warrant shall be deemed to have been exercised on the date the Exercise
Price is received by the Company. The Warrant Shares shall be deemed to
have been issued, and Holder or any other person so designated to be named
therein shall be deemed to have become a holder of record of such shares for
all purposes, as of the date the Warrant has been exercised by payment to
the Company of the Exercise Price and all taxes required to be paid by the
Holder, if any, pursuant to Section 2(d)(v) prior to the issuance of such
shares, have been paid.
iii. Delivery of New Warrants Upon Exercise. If this Warrant
shall have been exercised in part, the Company shall, at the time of
delivery of the certificate or certificates representing Warrant Shares,
deliver to Holder a new Warrant evidencing the rights of Holder to purchase
the unpurchased Warrant Shares called for by this Warrant, which new Warrant
shall in all other respects be identical with this Warrant.
iv. No Fractional Shares or Scrip. No fractional shares or
scrip representing fractional shares shall be issued upon the exercise of
this Warrant. As to any fraction of a share which Holder would otherwise be
entitled to purchase upon such exercise, the Company shall pay a cash
adjustment in respect of such final fraction in an amount equal to such
fraction multiplied by the Exercise Price.
v. Charges, Taxes and Expenses. Issuance of certificates for
Warrant Shares shall be made without charge to the Holder for any issue or
transfer tax or other incidental expense in respect of the issuance of such
certificate, all of which taxes and expenses shall be paid by the Company,
and such certificates shall be issued in the name of the Holder or in such
name or names as may be directed by the Holder; provided,
however, that in the event certificates for Warrant Shares are to be
issued in a name other than the name of the Holder, this Warrant when
surrendered for exercise shall be accompanied by the Assignment Form
attached hereto duly executed by the Holder; and the Company may require, as
a condition thereto, the payment of a sum sufficient to reimburse it for any
transfer tax incidental thereto.
vi. Closing of Books. The Company will not close its
stockholder books or records in any manner which prevents the timely
exercise of this Warrant, pursuant to the terms hereof.
Section 3. Certain Adjustments.
a) Stock Dividends and Splits. If the Company, at any time while this Warrant
is outstanding: (A) pays a stock dividend or otherwise makes a distribution or distributions
on shares of its Common Stock or any other equity or equity equivalent securities payable in
shares of Common Stock (which, for avoidance of doubt, shall not include any shares of
Common Stock issued by the Company pursuant to this Warrant), (B) subdivides outstanding
shares of Common Stock into a larger number of shares, (C) combines (including by way of
reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or
(D) issues by reclassification of shares of the Common Stock any shares of capital stock of
the Company, then in each case the Exercise Price shall be multiplied by a fraction of which
the numerator shall be the number of shares of Common Stock (excluding treasury shares, if
any) outstanding before such event and of which the denominator shall be the number of
shares of Common Stock outstanding after such event and the number of shares issuable upon
exercise of this Warrant shall be proportionately adjusted. Any adjustment made pursuant to
this Section 3(a) shall become effective immediately after the record date for the
determination of stockholders entitled to receive such dividend or distribution and shall
become effective immediately after the effective date in the case of a subdivision,
combination or re-classification.
b) Fundamental Transactions. If any capital reorganization, reclassification
of the capital stock of the Company, consolidation or merger of the Company with another
corporation in which the Company is not the survivor, or sale, transfer or other disposition
of all or substantially all of the
S-31
Companys assets to another corporation shall be effected, then the Company shall use
its best efforts to ensure that lawful and adequate provision shall be made whereby each
Holder shall thereafter continue to have the right to purchase and receive upon the basis
and upon the terms and conditions herein specified and in lieu of the Warrant Shares
issuable upon exercise of this Warrant, such shares of stock, securities or assets as would
have been issuable or payable with respect to or in exchange for a number of Warrant Shares
equal to the number of Warrant Shares issuable upon exercise of the Warrant, had such
reorganization, reclassification, consolidation, merger, sale, transfer or other disposition
not taken place, and in any such case appropriate provision shall be made with respect to
the rights and interests of each Holder to the end that the provisions hereof (including,
without limitation, provision for adjustment of the Exercise Price) shall thereafter be
applicable, as nearly equivalent as may be practicable in relation to any shares of stock,
securities or assets thereafter deliverable upon the exercise thereof. The Company shall
not effect any such consolidation, merger, sale, transfer or other disposition unless prior
to or simultaneously with the consummation thereof the successor corporation (if other than
the Company) resulting from such consolidation or merger, or the corporation purchasing or
otherwise acquiring such assets or other appropriate corporation or entity shall assume by
written instrument, reasonably deemed by both the Board of Directors of the Company and
Holders representing at least a majority of the Warrant Shares issuable upon exercise of all
Warrants issued in the same offering as this Warrant to be satisfactory in form and
substance, such affirmative assessment not be unreasonably withheld the obligation to deliver to the holder of the Warrant, at the last address of
such holder appearing on the books of the Company, such shares of stock, securities or
assets as, in accordance with the foregoing provisions, such holder may be entitled to
purchase, and the other obligations of the Company under this Warrant. The provisions of
this section shall similarly apply to successive reorganizations, reclassifications,
consolidations, mergers, sales, transfers or other dispositions. If the Company, in spite
of using its best efforts, is unable to cause this Warrant to continue in full force and
effect until the Expiration Date in connection with any capital reorganization,
reclassification of the capital stock of the Company, consolidation or merger of the Company
with another corporation in which the Company is not the survivor, or sale, transfer or
other disposition of all or substantially all of the Companys assets to another
corporation, then the Company shall pay the Holder an amount calculated in accordance with
the Black-Scholes Option Pricing formula set forth in the appendix hereto.
c) Calculations. All calculations under this Section 3 shall be made to the
nearest cent or the nearest 1/100th of a share, as the case may be. The number of shares of
Common Stock outstanding at any given time shall not include shares of Common Stock owned or
held by or for the account of the Company, and the description of any such shares of Common
Stock shall be considered on issue or sale of Common Stock. For purposes of this Section 3,
the number of shares of Common Stock deemed to be issued and outstanding as of a given date
shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any)
issued and outstanding.
d) Notice to Holders.
i. Adjustment to Exercise Price. Whenever the Exercise Price is
adjusted pursuant to this Section 3, the Company shall promptly mail to each
Holder a notice setting forth the Exercise Price after such adjustment and
setting forth a brief statement of the facts requiring such adjustment.
Notice to Allow Exercise by Holder. If (A) the Company shall
declare a dividend (or any other distribution) on the Common Stock; (B) the
Company shall declare a special nonrecurring cash dividend on or a
redemption of the Common Stock; (C) the Company shall authorize the granting
to all holders of the Common Stock rights or warrants to subscribe for or
purchase any shares of capital stock of any class or of any rights; (D) the
approval of any stockholders of the Company shall be required in connection
with any reclassification of the Common Stock, any consolidation or merger
to which the Company is a party, any sale or transfer of all or
substantially all of the assets of the Company, of any compulsory share
exchange whereby the Common Stock is converted into other securities, cash
or property; (E) the Company shall authorize the voluntary or involuntary
dissolution, liquidation or winding up of the affairs of the Company; then,
in each case, the Company shall cause to be mailed to the Holder at its
S-32
last addresses as it shall appear upon the Warrant Register of the
Company, at least twenty (20) calendar days prior to the applicable record
or effective date hereinafter specified, a notice stating (x) the date on
which a record is to be taken for the purpose of such dividend,
distribution, redemption, rights or warrants, or if a record is not to be
taken, the date as of which the holders of the Common Stock of record to be
entitled to such dividend, distributions, redemption, rights or warrants are
to be determined or (y) the date on which such reclassification,
consolidation, merger, sale, transfer or share exchange is expected to
become effective or close, and the date as of which it is expected that
holders of the Common Stock of record shall be entitled to exchange their
shares of the Common Stock for securities, cash or other property
deliverable upon such reclassification, consolidation, merger, sale,
transfer or share exchange; provided, that the failure to mail such
notice or any defect therein or in the mailing thereof shall not affect the
validity of the corporate action required to be specified in such notice.
The Holder is entitled to exercise this Warrant during the 20-day period
commencing the date of such notice to the effective date of the event
triggering such notice.
Section 4. Transfer of Warrant.
a) Right of First Refusal. Should the Holder propose to sell or transfer
this Warrant to a non-affiliate of Holder in response to a bona fide offer to
purchase, the Holder shall promptly deliver a written notice to the Company. The
notice shall describe in reasonable detail the proposed sale or transfer, including,
without limitation, the number of Warrant Shares to be sold or transferred, the
consideration to be paid, the name and address of each prospective purchaser or
transferee, and any other material terms and conditions upon which such sale or
transfer is to be made, along with copies of all material proposed agreements
relating to such sale, including purchase agreements and other agreements or
documents requested by the Company. The Company shall have the option, exercisable
upon written notice to the Holder within three (3) business days after delivery of
the notice, to purchase some or all of the Warrant Shares on the same terms as the
proposed sale or transfer. Upon such purchase by the Company, this Warrant shall
promptly be cancelled and the Company shall issue to the Holder a new Warrant
evidencing the portion of this Warrant not purchased by the Company, if any. If the
Company does not exercise its option to purchase this warrant, the Holder may sell
or transfer this Warrant to the purchaser or transferee identified in the notice, on
the same terms as identified in the notice or otherwise.
b) Transferability. Subject to compliance with any applicable securities
laws and the conditions set forth in Section 5(a) hereof and to the provisions of
Section 4.1 of the Purchase Agreement, this Warrant and all rights hereunder are
transferable, in whole or in part, upon surrender of this Warrant at the principal
office of the Company, together with a written assignment of this Warrant
substantially in the form attached hereto duly executed by the Holder or its agent
or attorney and funds sufficient to pay any transfer taxes payable upon the making
of such transfer. Upon such surrender and, if required, such payment, the Company
shall execute and deliver a new Warrant or Warrants in the name of the assignee or
assignees and in the denomination or denominations specified in such instrument of
assignment, and shall issue to the assignor a new Warrant evidencing the portion of
this Warrant not so assigned, and this Warrant shall promptly be cancelled. A
Warrant, if properly assigned, may be exercised by a new holder for the purchase of
Warrant Shares without having a new Warrant issued.
c) New Warrants. This Warrant may be divided or combined with other Warrants
upon presentation hereof at the aforesaid office of the Company, together with a
written notice specifying the names and denominations in which new Warrants are to
be issued, signed by the Holder or its agent or attorney. Subject to compliance
with Sections 4(a) and (b), as to any transfer which may be involved in such
division or combination, the Company shall execute and deliver a new Warrant or
Warrants in exchange for the Warrant or Warrants to be divided or combined in
accordance with such notice.
S-33
d) Warrant Register. The Company shall register this Warrant, upon records
to be maintained by the Company for that purpose (the Warrant Register),
in the name of the record Holder hereof from time to time. The Company may deem and
treat the registered Holder of this Warrant as the absolute owner hereof for the
purpose of any exercise hereof or any distribution to the Holder, and for all other
purposes, absent actual notice to the contrary.
Section 5. Miscellaneous.
a) Title to Warrant. Prior to the Expiration Date and subject to compliance
with applicable laws and Section 4 of this Warrant, this Warrant and all rights
hereunder are transferable, in whole or in part, at the office or agency of the
Company by the Holder in person or by duly authorized attorney, upon surrender of
this Warrant together with the Assignment Form annexed hereto properly endorsed.
The transferee shall sign an investment letter in form and substance reasonably
satisfactory to the Company.
b) No Rights as Shareholder Until Exercise. This Warrant does not entitle
the Holder to any voting rights or other rights as a shareholder of the Company
prior to the exercise hereof. Upon the surrender of this Warrant and the payment of
the aggregate Exercise Price (or by means of a cashless exercise), the Warrant
Shares so purchased shall be and be deemed to be issued to such Holder as the record
owner of such shares as of the close of business on the later of the date of such
surrender or payment.
c) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants
that upon receipt by the Company of evidence reasonably satisfactory to it of the
loss, theft, destruction or mutilation of this Warrant or any stock certificate
relating to the Warrant Shares, and in case of loss, theft or destruction, of
indemnity or security reasonably satisfactory to it (which, in the case of the
Warrant, shall not include the posting of any bond), and upon surrender and
cancellation of such Warrant or stock certificate, if mutilated, the Company will
make and deliver a new Warrant or stock certificate of like tenor and dated as of
such cancellation, in lieu of such Warrant or stock certificate.
d) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the
taking of any action or the expiration of any right required or granted herein shall
be a Saturday, Sunday or a legal holiday, then such action may be taken or such
right may be exercised on the next succeeding day not a Saturday, Sunday or legal
holiday.
e) Authorized Shares.
The Company covenants that during the period the Warrant is outstanding, it
will reserve from its authorized and unissued Common Stock a sufficient number of
shares to provide for the issuance of the Warrant Shares upon the exercise of any
purchase rights under this Warrant. The Company further covenants that its issuance
of this Warrant shall constitute full authority to its officers who are charged with
the duty of executing stock certificates to execute and issue the necessary
certificates for the Warrant Shares upon the exercise of the purchase rights under
this Warrant. The Company will take all such reasonable action as may be necessary
to assure that such Warrant Shares may be issued as provided herein without
violation of any applicable law or regulation, or of any requirements of the trading
markets upon which the Common Stock may be listed.
Except and to the extent as waived or consented to by the Holder, the Company
shall not by any action, including, without limitation, amending its certificate of
incorporation or through any reorganization, transfer of assets, consolidation,
merger, dissolution, issue or sale of securities or any other voluntary action,
avoid or seek to avoid the observance or performance of any of the terms of this
Warrant, but will at all times in good faith assist in the carrying out of all such
terms and in the taking of all such actions as may be necessary or appropriate to
protect the rights of Holder as set forth in this Warrant against impairment.
Without limiting the generality of the
S-34
foregoing, the Company will (a) not increase the par value of any Warrant
Shares above the amount payable therefor upon such exercise immediately prior to
such increase in par value, (b) take all such action as may be necessary or
appropriate in order that the Company may validly and legally issue fully paid and
nonassessable Warrant Shares upon the exercise of this Warrant, and (c) use
commercially reasonable efforts to obtain all such authorizations, exemptions or
consents from any public regulatory body having jurisdiction thereof as may be
necessary to enable the Company to perform its obligations under this Warrant.
f) Jurisdiction. All questions concerning the construction, validity,
enforcement and interpretation of this Warrant shall be determined in accordance
with the provisions of the Purchase Agreement.
g) Restrictions. The Holder acknowledges that the Warrant Shares acquired
upon the exercise of this Warrant, if not registered, will have restrictions upon
resale imposed by state and federal securities laws.
h) Nonwaiver and Expenses. No course of dealing or any delay or failure to
exercise any right hereunder on the part of Holder shall operate as a waiver of such
right or otherwise prejudice Holders rights, powers or remedies, notwithstanding
the fact that all rights hereunder terminate on the Expiration Date. If the Company
willfully and knowingly fails to comply with any provision of this Warrant, which
results in any material damages to the Holder, the Company shall pay to Holder such
amounts as shall be sufficient to cover any costs and expenses including, but not
limited to, reasonable attorneys fees, including those of appellate proceedings,
incurred by Holder in collecting any amounts due pursuant hereto or in otherwise
enforcing any of its rights, powers or remedies hereunder.
i) Notices. Any notice, request or other document required or permitted to
be given or delivered to the Holder by the Company shall be delivered in accordance
with the notice provisions of the Purchase Agreement.
j) Limitation of Liability. No provision hereof, in the absence of any
affirmative action by Holder to exercise this Warrant or purchase Warrant Shares,
and no enumeration herein of the rights or privileges of Holder, shall give rise to
any liability of Holder for the purchase price of any Common Stock or as a
stockholder of the Company, whether such liability is asserted by the Company or by
creditors of the Company.
k) Remedies. Holder, in addition to being entitled to exercise all rights
granted by law, including recovery of damages, will be entitled to specific
performance of its rights under this Warrant. The Company agrees that monetary
damages would not be adequate compensation for any loss incurred by reason of a
breach by it of the provisions of this Warrant and hereby agrees to waive the
defense in any action for specific performance that a remedy at law would be
adequate.
l) Successors and Assigns. Subject to applicable securities laws, this
Warrant and the rights and obligations evidenced hereby shall inure to the benefit
of and be binding upon the successors of the Company and the successors and
permitted assigns of Holder. The provisions of this Warrant are intended to be for
the benefit of all Holders from time to time of this Warrant and shall be
enforceable by any such Holder or holder of Warrant Shares but nothing in this
Warrant shall be construed to give any person or corporation or other entity, other
than the Company and the Holder and their respective successor and assigns, any
legal or equitable right, remedy or cause under this Warrant.
m) Amendment. This Warrant may be modified or amended or the provisions
hereof waived with the written consent of the Company and the Holder.
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n) Severability. Wherever possible, each provision of this Warrant shall be
interpreted in such manner as to be effective and valid under applicable law, but if
any provision of this Warrant shall be prohibited by or invalid under applicable
law, such provision shall be ineffective to the extent of such prohibition or
invalidity, without invalidating the remainder of such provisions or the remaining
provisions of this Warrant.
o) Headings. The headings used in this Warrant are for the convenience of
reference only and shall not, for any purpose, be deemed a part of this Warrant.
********************
S-36
APPENDIX
Black Scholes Option Pricing formula to be used when calculating the amount per Warrant Share
shall be: C = StN(d1) Ke-r(T-t)N(d2), where
C = warrant value
S = price of Company stock as determined by reference to the closing price on the securities
exchange or Nasdaq National Market over the 20-day period ending three trading days prior to the
closing of the capital reorganization, reclassification of the capital stock of the Company,
consolidation or merger of the Company with another corporation in which the Company is not the
survivor, or sale, transfer or other disposition of all or substantially all of the Companys
assets to another corporation described in Section 3(b) if the Companys stock is then traded on
such exchange or system, or the average of the closing bid or sale prices (whichever is applicable)
in the over-the-counter market over the 20-day period ending three trading days prior to the
closing of the transaction if the Companys stock is then actively traded in the over-the-counter
market, or the then most recently completed financing if the Companys stock is not then traded on
a securities exchange or system or in the over-the-counter market.
T = 9/14/2011
t = date of issue of warrant
T-t = time until warrant expiration = ___days or ___months
N = volatility = average of the daily price changes on the securities exchange or Nasdaq National
Market over the 20-day period ending three trading days prior to the public announcement of the
capital reorganization, reclassification of the capital stock of the Company, consolidation or
merger of the Company with another corporation in which the Company is not the survivor, or sale,
transfer or other disposition of all or substantially all of the Companys assets to another
corporation described in Section 3(b) if the Companys stock is then traded on such exchange or
system, or the average of the daily change in the closing bid or sale prices (whichever is
applicable) in the over-the-counter market over the 20-day period ending three trading days prior
to the public announcement of the transaction if the Companys stock is then actively traded in the
over-the-counter market, or 0.6 if the Companys stock is not then traded on a securities exchange
or system or in the over-the-counter market.
d1
= (ln(S/K) +
(r-l+N+N/2)(T-t)) ÷ (NÖ(T-t))
ln = natural logarithm
l = dividend rate for the most recent 12-month period at the time of closing of the capital
reorganization, reclassification of the capital stock of the Company, consolidation or merger of
the Company with another corporation in which the Company is not the survivor, or sale, transfer or
other disposition of all or substantially all of the Companys assets to another corporation.
K = $6.62
r = the 90-day Treasury Bill rate from the most recent auction reported on the website:
www.publicdebt.treas.gov
d2
= d1- NÖ(T-t)/365
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IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its
officer thereunto duly authorized.
Dated: September 14, 2005
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Spectrum Pharmaceuticals, Inc. |
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Title: |
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Attest: |
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By: |
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Name: |
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S-38
NOTICE OF EXERCISE
TO: SPECTRUM PHARMACEUTICALS, INC.
(1) The undersigned hereby elects:
o to purchase Warrant Shares, Warrant Number
, of the Company pursuant to the terms of the attached
Warrant and tenders herewith payment of the exercise price in full in lawful
money of the United States, together with all applicable transfer taxes, if
any.
o to exchange this Warrant for the number of Warrant Shares determined
pursuant to the net exchange procedure set forth in subsection 2(c).
(2) Please issue said Warrant Shares in the name of the undersigned or in such other name as
is specified below:
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The Warrant Shares shall be delivered to the following address: |
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OR |
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DWAC the shares to: |
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DTC # |
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Account # |
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Reference # |
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SIGNATURE OF HOLDER
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Signature of Authorized Signatory of Investing Entity
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S-39
ASSIGNMENT FORM
(To assign the foregoing warrant, execute
this form and supply required information.
Do not use this form to exercise the warrant.)
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Warrant Number:
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Warrant Shares: |
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FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby
assigned to:
Dated: ,
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Holders Signature: |
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Holders Address: |
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Signature Guaranteed:
NOTE: The signature to this Assignment Form must correspond with the name as it appears on the
face of the Warrant, without alteration or enlargement or any change whatsoever, and must be
guaranteed by a bank or trust company. Officers of the corporations and those acting in a
fiduciary or other representative capacity should file proper evidence of authority to assign the
foregoing Warrant.
S-40
You should rely only on the information contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus that is also part of this document. We have
not authorized anyone to provide information different from that contained or incorporated in this
prospectus supplement and the accompanying prospectus. We are offering to sell shares of common
stock and common stock warrants only in jurisdictions where offers and sales are permitted. The
information contained or incorporated in this prospectus supplement and the accompanying prospectus
is accurate only as of the date of such information, regardless of the time of delivery of this
prospectus supplement and the accompanying prospectus or of any sale of our common stock or common
stock warrants.
TABLE OF CONTENTS
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S-2 |
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S-4 |
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S-19 |
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S-20 |
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S-22 |
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S-24 |
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S-24 |
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S-29 |
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SPECTRUM
PHARMACEUTICALS, INC.
UP TO 6,517,691 SHARES OF COMMON
STOCK
AND
WARRANTS TO PURCHASE UP TO 3,258,845
SHARES OF COMMON STOCK
PROSPECTUS SUPPLEMENT
September ____, 2005
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