Filed
Pursuant to Rule 424(b)(5)
Registration No.
333-162374
Prospectus
Supplement
(To prospectus dated October 7,
2009)
3,747,558
shares of Common Stock, par value $0.001 per share
Series
A Warrants to Purchase up to 1,873,779 shares of Common Stock
Series
B Warrants to Purchase up to 1,873,779 shares of Common Stock
This prospectus supplement and the
accompanying prospectus relate to the offering for sale of 3,747,558 units,
consisting of (i) 3,747,558 shares of our common stock, (ii) warrants to
purchase an aggregate of up to 1,873,779 shares of our common stock (and the
shares of common stock issuable from time to time upon exercise of such
warrants), exercisable, subject to its terms, at $2.45 per share, during the
period beginning one hundred eighty (180) days after the date of issue and
ending on the fifth (5th) anniversary of the date of issue (the “Series A
Warrants”) and (iii) warrants to purchase an aggregate of up to 1,873,779
shares of our common stock (and the shares of common stock issuable from time to
time upon exercise of such warrants), exercisable, subject to its terms, at
$2.45 per share, during the period beginning one hundred eighty (180) days after
the date of issue and ending on the eighteen- (18) month anniversary of the date
of issue (the “Series B Warrants,” and collectively with the Series A Warrants,
the “Warrants”).
The purchase price for each unit
purchased in this offering is $2.00. Each unit consists of one share of our
common stock, one Series A Warrant exercisable for 0.5 of a share of our common
stock and one Series B Warrant exercisable for 0.5 of a share of our common
stock. Units will not be issued or certificated. The shares of our common stock
and the Warrants comprising the units will be issued
separately.
You should carefully read this
prospectus supplement and the accompanying prospectus, together with the
documents we incorporate by reference, before you invest in any of our
securities.
We have retained Ladenburg Thalmann
& Co. Inc. as our exclusive placement agent to use its best efforts to
solicit offers to purchase our securities in this offering. In addition to the
placement agent’s fee below, we have also agreed to issue the placement agent
warrants to purchase up to an aggregate of 74,951 shares of our common stock at
an exercise price of $2.50 per share. See “Plan of Distribution” beginning on
page S-32 of this prospectus supplement for more information regarding these
arrangements.
Our common stock is listed on The
Nasdaq Capital Market under the symbol “RPTP.” The last reported sale price of
our common stock on the Nasdaq Capital Market on December 17, 2009 was $2.45 per
share. The aggregate market value of our outstanding common equity
held by non-affiliates on December 17, 2009 was approximately $41,904,641. There
is no established public trading market for the offered Warrants and we do not
expect a market to develop. In addition, we do not intend to apply for listing
of the Warrants on any national securities exchange. We have not
issued any securities pursuant to Instruction I.B.6 of Form S-3 during the 12
calendar month period that ends on and includes the date of this prospectus
supplement.
This investment involves a high degree
of risk. See “Risk Factors” beginning on page S-10 of this prospectus supplement
and in our periodic reports filed with the Securities and Exchange Commission
and incorporated by reference herein for a discussion of the material risks you
should consider before making an investment in our common stock.
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Per
Unit
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Total
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Public
offering price
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$
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2.00
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$
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7,495,116
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Placement
agent’s fees
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$
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0.13
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$
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487,183
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Proceeds,
before expenses, to us
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$
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1.87
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$
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7,007,933
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We expect that delivery of the
securities being offered pursuant to this prospectus supplement will be made to
investors on or about December 22, 2009.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of
these securities or determined if this prospectus supplement or the accompanying
prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
Ladenburg
Thalmann & Co. Inc.
The date
of this prospectus supplement is December 17, 2009
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Prospectus
Supplement
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Forward-Looking
Statements
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ii
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Prospectus
Summary
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S-1
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Risk
Factors
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S-10
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Use
of Proceeds
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S-29
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Determination
of Offering Price
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S-29
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Dilution
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S-30
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Capitalization
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S-31
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Plan
of Distribution
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S-32
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Description
of Securities We Are Offering
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S-34
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Description
of Warrants
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S-34
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Legal
Matters
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S-37
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Experts
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S-37
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Where
You Can Find More Information
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S-37
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Accompanying
Prospectus
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About
This Prospectus
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1
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Raptor
Pharmaceutical Corp.
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2
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Risk
Factors
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2
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Forward-Looking
Statements
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3
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The
Securities We May Offer
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4
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Use
of Proceeds
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6
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Description
of Our Capital Stock
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6
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Description
of Debt Securities
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11
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Description
of Warrants
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14
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Description
of Units
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15
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Legal
Ownership of Securities
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16
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Plan
of Distribution
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19
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Legal
Matters
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21
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Experts
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21
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Where
You Can Find Additional Information
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This
document has two parts. The first part is this prospectus supplement, which
describes the specific terms of the units consisting of our common stock and
warrants that we are offering and certain other matters relating to us. This
first part also adds to and updates information contained in the accompanying
prospectus and the documents incorporated by reference into this prospectus
supplement or the accompanying prospectus. The second part, the accompanying
prospectus, gives more general information about our company and securities we
may offer from time to time under our shelf registration statement, some of
which may not apply to this offering. If the information varies between this
prospectus supplement and the accompanying prospectus, or any document
incorporated by reference in this prospectus supplement or the accompanying
prospectus, you should rely on the information in this prospectus
supplement.
You
should read this entire document, including the prospectus supplement, the
accompanying prospectus and the documents incorporated by reference herein that
are described under “Where You Can Find More Information” before making your
investment decision. You should rely only on the information contained or
incorporated by reference in this prospectus supplement and the accompanying
prospectus. We have not authorized anyone to provide information different from
that contained or incorporated by reference in this prospectus supplement or the
accompanying prospectus. You should not assume that the information appearing in
this prospectus supplement, the accompanying prospectus, or information we
previously filed with the Securities and Exchange Commission, or the SEC, and
incorporated by reference herein is accurate as of any date other than their
respective dates, even though this prospectus supplement and any accompanying
prospectus is delivered or common stock and warrants are sold on a later date.
Our business, financial condition, results of operations and prospects may have
changed since those dates. These documents do not constitute an offer to sell or
solicitation of any offer to buy our shares of common stock or warrants to
purchase our shares of common stock in any circumstances under which the offer
or solicitation is unlawful.
i
In this
prospectus supplement and the accompanying prospectus, in other filings with the
SEC and in press releases and other public statements by our officers throughout
the year, we make or will make statements that plan for or anticipate the
future. These “forward-looking statements,” within the meaning of the Private
Securities Litigation Reform Act of 1995, include statements about our future
business plans and strategies, as well as other statements that are not
historical in nature. These forward-looking statements are based on our current
expectations.
In some
cases, these statements can be identified by the use of terminology such as
“believes,” “expects,” “anticipates,” “plans,” “may,” “might,” “will,” “could,”
“should,” “would,” “projects,” “anticipates,” “predicts,” “intends,”
“continues,” “estimates,” “potential,” “opportunity” or the negative of these
terms or other comparable terminology. All such statements, other than
statements of historical facts, including our financial condition, future
results of operation, projected revenues and expenses, business strategies,
operating efficiencies or synergies, competitive positions, growth opportunities
for existing intellectual properties, technologies, products, plans, and
objectives of management, markets for our securities, and other matters, are
about us and our industry that involve substantial risks and uncertainties and
constitute forward-looking statements for the purpose of the safe harbor
provided by Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act of 1934, as
amended, or the Exchange Act. Such forward-looking statements, wherever they
occur, are necessarily estimates reflecting the best judgment of our senior
management on the date on which they were made, or if no date is stated, as of
the date of the filing made with the SEC in which such statements were made. You
should not place undue reliance on these statements, which only reflect
information available as of the date that they were made. Our business’ actual
operations, performance, development and results might differ materially from
any forward-looking statement due to various known and unknown risks,
uncertainties, assumptions and contingencies, including those described in the
section titled “Risk Factors,” and including, but not limited to, the
following:
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our
need for, and our ability to obtain, additional funds;
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uncertainties
relating to clinical trials and regulatory reviews;
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our
dependence on a limited number of therapeutic
compounds;
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the
early stage of the products we are developing;
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the
acceptance of any of our future products by physicians and
patients;
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competition
and dependence on collaborative partners;
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loss
of key management or scientific personnel;
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our
ability to obtain adequate intellectual property protection and to enforce
these rights;
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our
ability to avoid infringement of the intellectual property rights of
others; and
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the
other factors and risks described under the section captioned “Risk
Factors” as well as other factors not identified
therein.
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Although
we believe that the expectations reflected in the forward-looking statements are
reasonable, the factors discussed in this prospectus supplement and the
accompanying prospectus, in other filings with the SEC and in press releases and
other public statements by our officers throughout the year, could cause actual
results or outcomes to differ materially and/or adversely from those expressed
in any forward-looking statements made by us or on our behalf, and therefore we
cannot guarantee future results, levels of activity, performance or achievements
and you should not place undue reliance on any such forward-looking statements.
We cannot give you any assurance that such forward-looking statements will prove
to be accurate and such forward-looking events may not occur. In light of the
significant uncertainties inherent in such forward-looking statements, you
should not regard the inclusion of this information as a representation by us or
any other person that the results or conditions described in those statements or
our objectives and plans will be achieved.
ii
This
summary highlights selected information concerning our business and this
offering of shares of our common stock and warrants to purchase shares of our
common stock. It is not complete and does not contain all of the information
that may be important to you and your investment decision. The following summary
is qualified in its entirety by the more detailed information and consolidated
financial statements and notes thereto included elsewhere or incorporated by
reference into this prospectus supplement and the accompanying prospectus. You
should carefully read this entire prospectus supplement and the accompanying
prospectus, including the information incorporated by reference herein, and
should consider, among other things, the matters set forth in “Risk
Factors”before making an investment decision. References to the terms “we,”
“us,” “our” and similar terms, refer to Raptor Pharmaceutical Corp. and its
wholly-owned subsidiaries on a consolidated basis, unless we state or the
context implies otherwise.
Our Business
Overview
We believe that we are building a
balanced pipeline of drug candidates that may expand the reach and benefit of
existing therapeutics. Our product portfolio includes both candidates from our
proprietary drug targeting platforms and in-licensed and acquired product
candidates.
Our current pipeline includes three
clinical development programs which we are actively developing. We also have
three other clinical-stage product candidates, for which we are seeking business
development partners but are not actively developing, and we have four
preclinical product candidates we are developing, three of which are based upon
our proprietary drug-targeting platforms.
Clinical Development
Programs
Our three active clinical development
programs are based on an existing therapeutic that we are reformulating for
potential improvement in safety and/or efficacy and for application in new
disease indications. These clinical development programs include the
following:
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DR
Cysteamine for the potential treatment of nephropathic cystinosis, or
cystinosis, a rare genetic disorder;
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DR
Cysteamine for the potential treatment of non-alcoholic steatohepatitis,
or NASH, a metabolic disorder of the liver; and
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DR
Cysteamine for the potential treatment of Huntington’s Disease, or
HD.
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Other Clinical-Stage Product
Candidates
We have three clinical-stage product
candidates for which we are seeking partners:
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Convivia™
for the potential management of acetaldehyde toxicity due to alcohol
consumption by individuals with aldehyde dehydrogenase, or ALDH2
deficiency, an inherited metabolic disorder; and
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Tezampanel
and NGX426, non-opioids for the potential treatment of: migraine, acute
pain, and chronic pain.
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Preclinical Product
Candidates
Our preclinical platforms consist of
targeted therapeutics, which we are developing for the potential treatment of
multiple indications, including liver diseases, neurodegenerative diseases and
breast cancer:
Our receptor-associated protein, or
RAP, platform consists of: HepTide™ for the potential treatment of primary liver
cancer and hepatitis C; and NeuroTrans™ to potentially deliver therapeutics
across the blood-brain barrier for treatment of a variety of neurological
diseases.
Our mesoderm development protein, or
Mesd, platform consists of WntTide™ for the potential treatment of breast
cancer.
We are also examining our glutamate
receptor antagonists, tezampanel and NGX426, for the potential treatment of
thrombosis and spasticity disorders.
S-1
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DRUG
PRODUCT CANDIDATE
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DISEASE
INDICATION
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STAGE
OF DEVELOPMENT
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Delayed
release,
enterically
coated
cysteamine
bitartrate,
or
DR Cysteamine
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cystinosis
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Phase
IIb
(completed, Phase III planned
for 2010)
Orphan
Product Designation
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DR
Cysteamine
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NASH
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Phase
IIa
(ongoing,
open IND)
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DR
Cysteamine
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HD
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Phase
II
(planned for
2010)
Orphan
Product Designation
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ConviviaTM
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ALDH2
Deficiency, or Ethanol
Intolerance
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Business
Development Opportunity
(Phase
IIa completed)
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Tezampanel
and NGX 426
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Migraine
and Pain
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Business
Development Opportunity
(Phase
I/II completed)
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HepTideTM
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Hepatocellular
Carcinoma, or HCC and Hepatitis
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Preclinical
(ongoing)
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WntTideTM
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Breast
Cancer
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Preclinical
(ongoing)
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NeuroTransTM
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Neurodegenerative
Diseases
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Preclinical
Roche
collaboration
(ongoing)
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Tezampanel
and NGX 426
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Thrombosis
and Spasticity Disorder
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Preclinical
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Future
Activities
Over the next 12 months, we plan to
conduct research and development activities based upon our DR Cysteamine
clinical programs and continued development of our preclinical product
candidates. We also plan to actively seek business development partners for our
ConviviaTM
product candidate and Tezampanel and NGX426. We may also develop future
in-licensed technologies and acquired technologies. A brief summary of our
primary objectives in the next 12 months for our research and development
activities is provided below. Our Plans for research and development activities
over the next 12 months can only be implemented if we are successful in raising
significant funds during this period. In addition, there can be no assurances
that our research and development activities will be successful. If we do not
make important progress towards achieving at least one of our major clinical
objectives, this could adversely impact our ability to raise significant
additional funds, which could adversely impact our ability to continue as a
going concern.
Clinical
Development Programs
We develop clinical-stage drug product
candidates which are: internally discovered therapeutic candidates based on our
novel drug delivery platforms and in-licensed or purchased clinical-stage
products which may be new chemical entities in mid-to-late stage clinical
development, currently approved drugs with potential efficacy in additional
indications, and treatments that we could repurpose or reformulate as
potentially more effective or convenient treatments for a drug’s currently
approved indications.
S-2
Development of DR Cysteamine for the
Potential Treatment of Nephropathic Cystinosis or Cystinosis
Our DR Cysteamine product candidate is
a proprietary delayed-release, enteric-coated microbead formulation of
cysteamine bitartrate contained in a gelatin capsule. We are investigating DR
Cysteamine for the potential treatment of cystinosis.
We believe that immediate-release
cysteamine bitartrate, a cystine-depleting agent, is currently the only U.S.
Food and Drug Administration, or FDA, and the European Medicines Agency, or
EMEA, approved drug to treat cystinosis, a rare genetic disease.
Immediate-release cysteamine is effective at preventing or delaying kidney
failure and other serious health problems in cystinosis patients. However,
patient compliance is challenging due to the requirement for frequent dosing and
gastrointestinal side effects. Our DR Cysteamine for the potential treatment of
cystinosis is designed to mitigate some of these difficulties. It is expected to
be dosed twice daily, compared to the current every-six-hour dosing schedule. In
addition, DR Cysteamine is designed to pass through the stomach and deliver the
drug directly to the small intestine, where it is more easily absorbed into the
bloodstream and may result in fewer gastrointestinal side effects.
The FDA granted orphan drug designation
for DR Cysteamine for the treatment of cystinosis in 2006.
In June 2009, we commenced our Phase
IIb clinical trial of DR Cysteamine in cystinosis, in which we enrolled nine
cystinosis patients with histories of compliance using the currently available
immediate-release form of cysteamine bitartrate. The clinical trial, which was
conducted at the University of California at San Diego, or UCSD, evaluated
safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of
DR Cysteamine in patients. In November 2009, we released the data from the study
which achieved its goal by demonstrating improved tolerability and the potential
to reduce total daily dosage and administration frequency compared to
immediate-release cysteamine bitartrate. We plan to follow the Phase IIb
clinical study with a pivotal, Phase III clinical study in cystinosis patients
anticipated to commence in early 2010. While we plan to commercialize DR
Cysteamine in the U.S. by ourselves, we are actively reviewing potential
development partners for DR Cysteamine for markets outside of the U.S. with
companies that have experience in clinical development and commercialization of
orphan drugs in various ex-U.S. countries.
Development of DR Cysteamine for the
Potential Treatment of Non-Alcoholic Steatohepatitis or NASH
In October 2008, we commenced a
clinical trial in collaboration with UCSD to investigate a prototype formulation
of DR Cysteamine for the treatment of NASH in juvenile patients. In October
2009, we announced positive findings from the completed treatment phase of this
open-label Phase IIa clinical trial. At the completion of the initial six-month
treatment phase, the study achieved the primary endpoint: mean blood levels of
alanine aminotransferase, or ALT, a common biomarker for NASH, were reduced by
over 50%. Additionally, over half of the study participants had achieved
normalized ALT levels by the end of the treatment phase.
There are no currently approved drug
therapies for NASH, and patients are limited to lifestyle changes such as diet,
exercise and weight reduction to manage the disease. DR Cysteamine represents an
important potential treatment option for patients with NASH. Although NASH is
most common in insulin-resistant obese adults with diabetes and abnormal serum
lipid profiles, its prevalence is increasing among juveniles as obesity rates
rise within this patient population. Although most patients are asymptomatic and
feel healthy, NASH causes decreased liver function and can lead to cirrhosis,
liver failure and end-stage liver disease.
The NASH trial entails six months of
treatment followed by a six-month post-treatment monitoring period. Eligible
patients with baseline ALT and aspartate aminotransferase or AST measurements at
least twice that of normal levels were enrolled to receive twice-daily,
escalating oral doses of up to 1,000 mg of DR Cysteamine. The trial currently
has enrolled eleven NASH patients between 11-18 years old. No major adverse
events were reported during the six-month treatment phase. Trial subjects
continue to be monitored during the six-month post-treatment period currently
underway. Full results are being submitted for peer review by UCSD and us, and
are expected to be presented in 2010.
S-3
Development of DR Cysteamine for the
Potential Treatment of Huntington’s Disease or HD
Huntington’s Disease, or HD, is a
fatal, inherited degenerative neurological disease affecting about 30,000 people
in the U.S. and a comparable number of people in Europe. We are not aware of any
treatment for HD other than therapeutics that minimize symptoms such as the
uncontrollable movements and mood swings resulting from HD. We are collaborating
with a French institution, CHU d’ Angers, on a Phase II clinical trial
investigating DR Cysteamine in HD patients, anticipated to begin in early 2010.
We are providing the clinical trial materials for the study, which is sponsored
by CHU d’ Angers and funded in part by a grant from the French government. We
were granted Orphan Drug Designation in the U.S. by the FDA for cysteamine as a
potential treatment for HD in 2008.
Other Clinical-Stage Product
Candidates
We have three clinical-stage product
candidates for which we are seeking partners.
ConviviaTM
for Liver Aldehyde
Dehydrogenase Deficiency
Convivia™ is our proprietary oral
formulation of 4-methylpyrazole, or 4-MP, intended for the potential treatment
of acetaldehyde toxicity resulting from alcohol consumption in individuals with
ALDH2 deficiency, which is an inherited disorder of the body’s ability to
breakdown ethanol, commonly referred to as alcohol intolerance. 4-MP is
presently marketed in the U.S. and E.U. in an intravenous form as an anti-toxin.
ConviviaTM is
designed to lower systemic levels of acetaldehyde (a carcinogen) and reduce
symptoms, such as tachycardia and flushing, associated with alcohol consumption
by ALDH2-deficient individuals. ConviviaTM is a
capsule designed to be taken approximately 30 minutes prior to consuming an
alcoholic beverage.
In 2008, we completed a Phase IIa dose
escalation clinical trial of oral 4-MP with ethanol in ALDH2 deficient patients.
The study results demonstrated that the active ingredient in ConviviaTM
significantly reduced heart palpitations (tachycardia), which are commonly
experienced by ALDH2 deficient people who drink, at all dose levels tested. The
study also found that the 4-MP significantly reduced peak acetaldehyde levels
and total acetaldehyde exposure in a subset of the study participants who
possess specific genetic variants of the liver ADH and ALDH2 enzymes. We believe
that this subset represents approximately one-third of East Asian populations.
We are actively seeking corporate partnerships with pharmaceutical companies in
selected Asian countries to continue clinical development of ConviviaTM in
those countries.
Tezampanel and NGX426 for the
Potential Treatment of Migraine and Pain
Tezampanel and NGX426, the oral prodrug
of tezampanel, are what we believe to be first-in-class compounds that may
represent novel treatments for both pain and non-pain indications. Tezampanel
and NGX426 are receptor antagonists that target and inhibit a specific group of
receptors—the AMPA and kainate glutamate receptors—found in the brain and other
tissues. While normal glutamate production is essential, excess glutamate
production, either through injury or disease, has been implicated in a number of
diseases and disorders. Published data show that during a migraine, increased
levels of glutamate activate AMPA and kainate receptors, result in the
transmission of pain and, in many patients, the development of increased pain
sensitivity.
By acting at both the AMPA and kainate
receptor sites to competitively block the binding of glutamate, tezampanel and
NGX426 have the potential to treat a number of diseases and disorders. These
include chronic pain, such as migraine and neuropathic pain, muscle spasticity
and a condition known as central sensitization, a persistent and acute
sensitivity to pain.
Results of a Phase IIb clinical trial
of tezampanel were released in October 2007. In the trial, a single dose of
tezampanel given by injection was statistically significant compared to placebo
in treating acute migraine headache. This was the sixth Phase II trial in which
tezampanel has been shown to have analgesic activity. Based on a review of the
Phase II data, the FDA previously agreed that tezampanel may move forward into a
Phase III program for acute migraine.
In December 2008, results of NGX426 in
a human experimental model of cutaneous pain, hyperalgesia and allodynia
demonstrated a statistically significant reduction in spontaneous pain,
hyperalgesia and allodynia compared to placebo following injections of capsaicin
(i.e., chili oil) under the skin. In February 2009, results from a Phase 1
multiple dose trial of NGX426 showed that the compound is safe and
well-tolerated in healthy male and female subjects when dosed once daily for
five consecutive days.
In November 2009, we announced the
presentation of clinical trial data on NGX426 at the 12th International
Conference on the Mechanisms and Treatment of Neuropathic Pain. The results of
the study led by Mark Wallace, M.D., Professor of Clinical Anesthesiology at the
Center for Pain Medicine of the University of California at San Diego, suggested
that NGX426 has the potential to be effective in a variety of
neuropathic pain states, which are caused by damage to or dysfunction of the
peripheral or central nervous system rather than stimulation of pain
receptors.
S-4
We are currently seeking program
funding, development collaborations or out-licensing partners for the migraine
and pain programs.
Preclinical
Product Candidates
We are also developing a drug-targeting
platform based on the proprietary use of RAP and Mesd. We believe that these
proteins may have therapeutic applications in cancer, infectious diseases and
neurodegenerative diseases, among others.
These applications are based on the
assumption that our targeting molecules can be engineered to bind to a selective
subset of receptors with restricted tissue distribution under particular
conditions of administration. We believe these selective tissue distributions
can be used to deliver drugs to the liver or to other tissues, such as the
brain.
In addition to selectively transporting
drugs to specific tissues, selective receptor binding constitutes a means by
which receptor function might be specifically controlled, either through
modulating its binding capacity or its prevalence on the cell surface. Mesd is
being engineered for this latter application.
HepTideTM
for Hepatocellular Carcinoma
and Hepatitis C
Drugs currently used to treat primary
liver cancer are often toxic to other organs and tissues. We believe that the
pharmacokinetic behavior of RAP (i.e., the determination of the fate or
disposition of RAP once administered to a living organism) may diminish the
non-target toxicity and increase the on-target efficacy of attached
therapeutics.
In preclinical studies of our
radio-labeled HepTideTM (a
variant of RAP), HepTideTM, our
proprietary drug-targeting peptide was shown to distribute predominately to the
liver. Radio-labeled HepTideTM
which was tested in a preclinical research model of HCC, at the National
Research Council in Winnipeg, Manitoba, Canada, showed 4.5 times more delivery
to the liver than the radio-labeled control. Another study of radio-labeled
HepTideTM in a
non-HCC preclinical model, showed 7 times more delivery to the liver than the
radio-labeled control, with significantly smaller amounts of radio-labeled
HepTideTM
delivery to other tissues and organs.
HCC is caused by the malignant
transformation of hepatocytes, epithelial cells lining the vascular sinusoids of
the liver, or their progenitors. HepTideTM has
shown to bind to lipoprotein receptor-related protein, or LRP1, receptors on
hepatocytes. We believe that the pharmacokinetics and systemic toxicity of a
number of potent anti-tumor agents may be controlled in this way.
There are additional factors that favor
the suitability of RAP as an HCC targeting agent:
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RAP
is captured by hepatocytes with efficiency, primarily on
first-pass.
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Late-stage
HCC is perfused exclusively by the hepatic artery, while the majority of
the liver is primarily perfused through the portal
vein.
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Studies have shown that the RAP
receptor, LRP1, is well expressed on human HCC and under-expressed on
non-cancerous, but otherwise diseased, hepatocytes. Also, LRP1 expression is
maintained on metastasized HCC. These factors will favor delivery of RAP
peptide-conjugated anti-tumor agents to tumor cells, whether in the liver or at
metastasized sites.
We are evaluating conjugates between
HepTideTM and
a chemotherapeutic for testing in vitro and in appropriate preclinical models
for the potential treatment of HCC.
S-5
We are also evaluating conjugates
between HepTideTM and
an antiviral agent for testing in vitro and in appropriate preclinical models
for the potential treatment of hepatitis C.
NeuroTransTM
for the Potential Treatment of
Diseases Affecting the Brain
Hundreds of known genetic and
neurodegenerative diseases affect the brain. Drugs often have difficulty
reaching these disease-affected areas because the brain has evolved a protective
barrier, commonly referred to as the blood-brain barrier.
Part of the solution to the medical
problem of neurodegenerative diseases is the creation of effective brain
targeting and delivery technologies. One of the most obvious ways of delivering
therapeutics to the brain is via the brain’s extensive vascular network.
Treating these diseases by delivering therapeutics into the brain in a minimally
invasive way, including through a natural receptor mediated transport mechanism
called transcytosis, is a vision shared by many researchers and clinicians in
the neuroscience and neuromedical fields.
NeuroTrans™ is our proprietary
RAP-based technology program to research the delivery of therapeutics across the
blood-brain barrier. We believe our NeuroTrans™ platform may provide therapies
that will be safer, less intrusive and more effective than current approaches in
treating a wide variety of brain disorders.
In preclinical studies, NeuroTrans™ has
been conjugated to a variety of protein drugs, including enzymes and growth
factors, without interfering with the function of either fusion partner. Studies
indicate that radio-labeled NeuroTrans™ may be transcytosed across the
blood-brain barrier and that fusions between NeuroTrans™ and therapeutic
proteins may be manufactured economically. Experiments conducted in
collaboration with Stanford University in 2008 support the NeuroTrans™ peptide’s
ability to enhance the transport of cargo molecules into the cells that line the
blood-brain barrier.
In June 2009, we entered into a
collaboration and licensing agreement with F. Hoffman — La Roche Ltd. and
Hoffman—La Roche Inc., or Roche, to evaluate therapeutic delivery across the
blood-brain barrier utilizing NeuroTrans™. Under terms of the agreement, Roche
has funded studies of select molecules attached to NeuroTrans™. The agreement
provides Roche with an exclusive worldwide license to NeuroTrans™ for use in the
delivery of diagnostic and therapeutic molecules across the blood-brain barrier.
Roche’s and our scientists will actively collaborate on the project. We have
received an initial upfront payment for the collaboration to cover our portion
of the initial studies, and may earn development milestone payments and
royalties in exchange for the licensing of NeuroTrans™ to Roche.
WntTideTM
for the Potential Treatment of
Cancer
Human Mesd is a natural inhibitor of
the receptor LRP6. LRP6 has recently been shown to play a role in the
progression of some breast tumors. Studies in the laboratory of Professor Guojun
Bu, one of our scientific advisors, at the Washington University in St. Louis
Medical School have demonstrated the potential of Mesd and related peptides to
target these tumors. These molecules and applications are licensed to us from
Washington University.
WntTide™ is our proprietary, Mesd-based
peptide that we are developing as a potential therapeutic to inhibit the growth
and metastasis of tumors over-expressing LRP5 or LRP6. We have licensed the use
of Mesd from Washington University in St. Louis for the potential treatment of
cancer and bone density disorders.
In April 2009, Washington University
conducted a preclinical study of WntTide™ in a breast cancer model which showed
tumor inhibition. The results of this study were presented at the 2nd Annual Wnt
Conference in Washington, D.C., in June 2009 and will likely be published in the
first quarter of 2010. We are currently planning another breast tumor
preclinical model study with researchers at Washington University in the
continued development of WntTide™.
S-6
Tezampanel and NGX426 for the
Potential Treatment of Thrombotic Disorder
Research conducted at Johns Hopkins
University, or JHU, by Craig Morrell, D.V.M., Ph.D., and Charles Lowenstein,
M.D. demonstrated the importance of glutamate release in promoting platelet
activation and thrombosis. Research shows that platelets treated with an
AMPA/kainate receptor antagonist such as tezampanel or NGX426 are more resistant
to glutamate-induced aggregation than untreated platelets. This identifies the
AMPA/kainate receptors on platelets targeted by tezampanel or NGX426 as a new
antithrombotic target with a different mechanism of action than Plavix®,
aspirin or tPA. We have licensed the intellectual property of Tezampanel and NGX
426 for the treatment of thrombotic disorder from JHU and are in discussions
with potential collaborators regarding the development of this product
candidate. Research conducted in Martin Marsala’s lab at UCSD has demonstrated
the utility of tezampanel in reducing spasticity elicited by activation of AMPA
receptors on spinal astrocytes following ischemic events. We intend to further
assess application of tezampanel in the treatment of spasticity.
Other Development
Areas
Securing Additional and
Complementary Technology Licenses from Others
We plan to establish additional
research collaborations with prominent universities and research labs currently
working on the development of potential targeting molecules, and to secure
licenses from these universities and labs for technology resulting from the
collaboration. No assurances can be made regarding our ability to establish such
collaborations over the next 12 months, or at all. We intend to focus our
in-licensing and product candidate acquisition activities on identifying
complementary therapeutics, therapeutic platforms that offer a number of
therapeutic targets, and clinical-stage therapeutics based on existing approved
drugs in order to create proprietary reformulations to improve safety and
efficacy or to expand such drugs’ clinical indications through additional
clinical trials. We may obtain these products through collaborations, joint
ventures or through merger and/or acquisitions with other biotechnology
companies.
Facilities
Our primary offices are located at 9
Commercial Blvd., Suite 200, Novato, CA 94949. Our phone number is (415)
382-8111 and our facsimile number is (415) 382-1368. Our website is
located at www.raptorpharma.com. The
information on our website is not incorporated by reference into this prospectus
supplement or the accompanying prospectus, and you should not consider it part
of this prospectus supplement or the accompanying prospectus.
Proprietary
Rights
We purchased from BioMarin the
intellectual property owned by BioMarin for the research and development of the
RAP technologies, including two patents, two pending patent applications and two
provisional patent applications in review in the U.S., and countries in Europe
and Asia and two trademarks for NeuroTrans™. Subsequent to the purchase from
BioMarin, we have filed at least four additional patent applications for our RAP
technologies. As of October 23, 2009, we own or have licensed eight patent
families of applications under prosecution in the U.S. and internationally. Two
of these families of applications relate to cysteamine and the remaining six
cover the RAP platform. Of the six RAP platform patent families, two patents
have issued in the U.S. and a patent has issued in each of Japan, Australia and
Europe. All other applications are awaiting or undergoing examination in a
variety of countries. We also entered into an exclusive worldwide license
agreement with Washington University for our Mesd program for the treatment of
cancer and bone diseases. We fund the prosecution of a patent application
covering this technology, entering national phase in the U.S. and
internationally in November 2009. In October 2007, we acquired intellectual
property assets from Convivia, Inc., a privately held pharmaceutical company,
including four filed patents for 4-MP as a potential treatment for ALDH2
deficiency. Since the acquisition of Convivia, Inc. assets, we filed a
provisional patent for trans-dermal formulation of 4-MP, a provisional patent
for genotype specific methods for treating human subjects using 4-methylpyrazole
and a patent based on botanically derived compound for treatment of ALDH2
deficiency. In December 2007, we acquired an exclusive worldwide license
agreement to pending patent applications from UCSD relating to our DR Cysteamine
program. In March 2008, we amended our license with UCSD to add exclusive
worldwide rights to develop DR Cysteamine for the potential treatment of NASH.
We also have a license from Eli Lilly & Co. for the intellectual property
related to tezampanel and NGX426 for pain indications and a license of
tezampanel and NGX 426 for the treatment of thrombotic disorder from JHU. We
fund the prosecution of a patent covering this technology, which entered
national phase in the U.S. in August, 2009.
S-7
The
Offering
The
following summary contains basic information about this offering of our common
stock and warrants to purchase our common stock, and it is not intended to be
complete. It does not contain all of the information that is important to you.
For a more complete understanding of our common stock and warrants to purchase
our common stock, please refer to the section of this prospectus supplement and
the accompanying prospectus titled, “Description of Securities We Are Offering”
and “Description of Warrants.”
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Issuer
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Raptor
Pharmaceutical Corp.
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Common
Stock offered hereby
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Up
to 3,747,558 shares.
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Warrants
to purchase common stock offered hereby
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Up
to 3,747,558 Warrants to purchase common stock. This prospectus
supplement also relates to the offering of shares of common stock issuable
upon exercise of the Warrants.
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Warrant
terms
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The
Warrants will be exercisable at a price of $2.45 per share and are
exercisable commencing one hundred eighty (180) days after the date of
issuance. The Series A Warrants have a term of five years terminating on
the fifth anniversary of the date of issue, and the Series B Warrants have
a term of eighteen (18) months terminating on the eighteen- (18) month
anniversary of the date of issue.
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Common
stock to be outstanding after this offering
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Up
to 22,579,515 shares of common stock.
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NASDAQ
listing
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Our
common stock is listed on the Nasdaq Capital Market
under the symbol “RPTP.” There is no established public trading market for
the offered Warrants and we do not expect a market to develop. In
addition, we do not intend to apply for listing of the Warrants on any
national securities exchange.
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Use
of proceeds
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The
net proceeds from this offering, after deducting the placement agent’s
fees and our estimated expenses, will be approximately $6.9 million, based
on a public offering price of $2.00 per share. We expect to use
the net proceeds from the offering to fund part of our capital expenditure
program and for other corporate purposes. See “Use of Proceeds” on page
S-29 of this prospectus supplement.
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Dividend
policy
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We
intend to retain all future earnings, if any, to fund the development and
growth of our business. We do not anticipate paying cash
dividends on our common stock.
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Risk
factors
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This
investment involves a high degree of risk. See “Risk Factors” beginning on
page S-10 of this prospectus
supplement.
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S-8
Unless otherwise indicated, this
prospectus supplement does not assume that any of the Warrants will be
exercised. The number of shares of common stock to be outstanding after this
offering is based on 18,831,957 shares of our common stock outstanding as of
December 17, 2009. The number of shares of common stock to be outstanding after
this offering excludes:
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1,186,610 shares of our common stock issuable upon the exercise of options
outstanding under our stock option plans at a weighted average exercise
price of $19.14 per share;
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·
1,222,795 shares of our common stock available for future issuance
under our stock option plans;
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·
2,020,793 shares of our common stock issuable upon exercise of
various outstanding warrants at a weighted average exercise price of $3.07
per share;
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·
Up to 3,747,558 shares of common stock issuable upon the exercise
of the Warrants issued hereunder;
and
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·
Up to 74,951 shares of common stock issuable upon the exercise of
warrants issued to the placement agent as described in this prospectus
supplement.
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S-9
An
investment in our securities involves a high degree of risk. Before you decide
to invest in our securities, you should consider carefully all of the
information in this prospectus supplement and the accompanying prospectus,
including the risks and uncertainties described below, as well as other
information included in or incorporated by reference into this prospectus
supplement and the accompanying prospectus, particularly the specific risk
factors discussed in the sections titled “Risk Factors” contained in our filings
with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934, as amended, before deciding whether to invest in our
securities. Any of these risks could have a material adverse effect on our
business, prospects, financial condition and results of operations. In any such
case, the trading price of our common stock could decline and you could lose all
or part of your investment. You should also refer to the other information
contained in this prospectus supplement and the accompanying prospectus, or
incorporated by reference, including our financial statements and the notes to
those statements, and the information set forth under the caption
“Forward-Looking Statements.” The risks described below and contained in
our other periodic reports are not the only ones that we face. Additional
risks not presently known to us or that we currently deem immaterial may also
adversely affect our business operations.
Risks Related to Our
Business
If we fail to
obtain the capital necessary to fund our operations, our financial results,
financial condition and our ability to continue as a going concern will be
adversely affected and we will have to delay or terminate some or all of our
product development programs.
Our consolidated financial statements
as of August 31, 2009 have been prepared assuming that we will continue as a
going concern. As of August 31, 2009, we had an accumulated deficit of
approximately $21.9 million. We expect to continue to incur losses for the
foreseeable future and will have to raise substantial cash to fund our planned
operations. Our recurring losses from operations and our
stockholders’ deficit raise substantial doubt about our ability to continue as a
going concern and, as a result, our independent registered public accounting
firm included an explanatory paragraph in its report on our consolidated
financial statements for the year ended August 31, 2009, which is incorporated
herein by reference, with respect to this uncertainty. We will need to generate
significant revenue or raise additional capital to continue to operate as a
going concern. In addition, the perception that we may not be able to continue
as a going concern may cause others to choose not to deal with us due to
concerns about our ability to meet our contractual obligations and may adversely
affect our ability to raise additional capital.
We believe that our cash and cash
equivalents balances as of December 16, 2009, will be sufficient to meet our
obligations into the first calendar quarter of 2010. Assuming the
full 3,747,558 units that are the subject of this offering are sold at a price
to the public of $2.00 per share, the net proceeds from this offering, after
deducting the placement agent’s fees and our estimated expenses, will be
approximately $6.9 million, which, if aggregated with our cash and cash
equivalents balances as of December 16, 2009, would likely be sufficient to meet
our obligations into the third quarter of 2010. We are currently in
the process of negotiating strategic partnerships and collaborations in order to
fully fund our preclinical and clinical programs in and beyond the third quarter
of 2010. These estimates are based on assumptions that may prove to be wrong. In
addition to the activities described herein above, we anticipate that we will
need to raise funds in the future for the continued development of our drug
development programs. We will need to sell equity or debt securities to raise
significant additional funds. The sale of additional securities is likely to
result in additional dilution to our stockholders. Additional financing may not
be available in amounts or on terms satisfactory to us or at all. We may be
unable to raise additional financing due to a variety of factors, including our
financial condition, the status of our research and development programs, and
the general condition of the financial markets. If we fail to raise significant
additional financing, we will have to delay or terminate some or all of our
research and development programs, our financial condition and operating results
will be adversely affected and we may have to cease our operations.
S-10
If we obtain significant additional
financing, we expect to continue to spend substantial amounts of capital on our
operations for the foreseeable future. The amount of additional capital we will
need depends on many factors, including:
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the
progress, timing and scope of our preclinical studies and clinical
trials;
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the
time and cost necessary to obtain regulatory approvals;
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the
time and cost necessary to develop commercial manufacturing processes,
including quality systems, and to build or acquire manufacturing
capabilities;
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the
time and cost necessary to respond to technological and market
developments; and
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any
changes made or new developments in our existing collaborative, licensing
and other corporate relationships or any new collaborative, licensing and
other commercial relationships that we may
establish.
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Moreover, our fixed expenses such as
rent, collaboration and license payments and other contractual commitments are
substantial and will likely increase in the future. These fixed expenses are
likely to increase because we expect to enter into:
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additional
licenses and collaborative agreements;
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contracts
for manufacturing, clinical and preclinical research, consulting,
maintenance and administrative services; and
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financing
facilities.
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We are an early development stage
company and have not generated any revenues to date and have a limited operating
history. Many of our drug product candidates are in the concept stage and have
not undergone significant testing in preclinical studies or any testing in
clinical trials. Moreover, we cannot be certain that our research and
development efforts will be successful or, if successful, that our drug product
candidates will ever be approved for sale or generate commercial revenues. We
have a limited relevant operating history upon which an evaluation of our
performance and prospects can be made. We are subject to all of the business
risks associated with a new enterprise, including, but not limited to, risks of
unforeseen capital requirements, failure of drug product candidates either in
preclinical testing or in clinical trials, failure to establish business
relationships, and competitive disadvantages against larger and more established
companies.
The current
disruptions in the financial markets could affect our ability to obtain
financing on favorable terms (or at all).
The U.S. credit markets have recently
experienced historic dislocations and liquidity disruptions which have caused
financing to be unavailable in many cases and, even if available, have caused
the cost of prospective financings to increase. These circumstances have
materially impacted liquidity in the debt markets, making financing terms for
borrowers able to find financing less attractive, and in many cases have
resulted in the unavailability of certain types of debt financing. Continued
uncertainty in the debt and equity markets may negatively impact our ability to
access financing on favorable terms or at all. In addition, Federal legislation
to deal with the current disruptions in the financial markets could have an
adverse affect on our ability to raise other types of financing.
S-11
Even if we are
able to develop our drug product candidates, we may not be able to receive
regulatory approval, or if approved, we may not be able to generate significant
revenues or successfully commercialize our products, which would adversely
affect our financial results and financial condition and we would have to delay
or terminate some or all of our research product development
programs.
All of our drug product candidates are
at an early stage of development and will require extensive additional research
and development, including preclinical testing and clinical trials, as well as
regulatory approvals, before we can market them. Since our inception
in 1997, and since Raptor Pharmaceuticals Corp. began operations in 2005, both
companies have dedicated substantially all of their resources to the research
and development of their technologies and related compounds. All of our
compounds currently are in preclinical or clinical development, and none have
been submitted for marketing approval. Our preclinical compounds may not enter
human clinical trials on a timely basis, if at all, and we may not develop any
product candidates suitable for commercialization. We cannot
predict if or when any of the drug product candidates we intend to develop will
be approved for marketing. There are many reasons that we may fail in our
efforts to develop our drug product candidates. These include:
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the
possibility that preclinical testing or clinical trials may show that our
drug product candidates are ineffective and/or cause harmful side
effects;
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our
drug product candidates may prove to be too expensive to manufacture or
administer to patients;
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our
drug product candidates may fail to receive necessary regulatory approvals
from the FDA or foreign regulatory authorities in a timely manner, or at
all;
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our
drug product candidates, if approved, may not be produced in commercial
quantities or at reasonable costs;
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our
drug product candidates, if approved, may not achieve commercial
acceptance;
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regulatory
or governmental authorities may apply restrictions to our drug product
candidates, which could adversely affect their commercial success;
and
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the
proprietary rights of other parties may prevent us or our potential
collaborative partners from marketing our drug product
candidates.
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If we fail to develop our drug product
candidates, our financial results and financial condition will be adversely
affected, we will have to delay or terminate some or all of our research product
development programs and may be forced to cease operations.
If we are limited
in our ability to utilize acquired or licensed technologies, we may be unable to
develop, out-license, market and sell our product candidates, which could cause
delayed new product introductions, and/or adversely affect our reputation, any
of which could have a material adverse effect on our business, prospects,
financial condition, and operating results.
We have acquired and licensed certain
proprietary technologies, discussed in the following risk factors, and plan to
further license and acquire various patents and proprietary technologies owned
by third parties. These agreements are critical to our product development
programs. These agreements may be terminated, and all rights to the technologies
and product candidates will be lost, if we fail to perform our obligations under
these agreements and licenses in accordance with their terms including, but not
limited to, our ability to make all payments due under such agreements. Our
inability to continue to maintain these technologies could materially adversely
affect our business, prospects, financial condition, and operating results. In
addition, our business strategy depends on the successful development of these
licensed and acquired technologies into commercial products, and, therefore, any
limitations on our ability to utilize these technologies may impair our ability
to develop, out-license, market and sell our product candidates, delay new
product introductions, and/or adversely affect our reputation, any of which
could have a material adverse effect on our business, prospects, financial
condition, and operating results.
S-12
If the purchase
or licensing agreements we entered into are terminated, we will lose the right
to use or exploit our owned and licensed technologies, in which case we will
have to delay or terminate some or all of our research and development programs,
our financial condition and operating results will be adversely affected and we
may have to cease our operations.
We entered into an asset purchase
agreement with BioMarin Pharmaceutical Inc., or BioMarin, for the purchase of
intellectual property related to the receptor-associated protein, or RAP,
technology, a licensing agreement with Washington University for mesoderm
development protein, or Mesd, and a licensing agreement with UCSD for DR
Cysteamine. BioMarin, Washington University and UCSD may terminate their
respective agreements with us upon the occurrence of certain events, including
if we enter into certain bankruptcy proceedings or if we materially breach our
payment obligations and fail to remedy the breach within the permitted cure
periods. Although we are not currently involved in any bankruptcy proceedings or
in breach of these agreements, there is a risk that we may be in the future,
giving BioMarin, Washington University and UCSD the right to terminate their
respective agreements with us. We have the right to terminate these agreements
at any time by giving prior written notice. If the BioMarin, Washington
University or UCSD agreements are terminated by either party, we would be forced
to assign back to BioMarin, in the case of the BioMarin agreement, all of our
rights, title and interest in and to the intellectual property related to the
RAP technology, would lose our rights to the Mesd technology, in the case of the
Washington University agreement and would lose our rights to DR Cysteamine, in
the case of UCSD. Under such circumstances, we would have no further right to
use or exploit the patents, copyrights or trademarks in those respective
technologies. If this happens, we will have to delay or terminate some or all of
our research and development programs, our financial condition and operating
results will be adversely affected, and we may have to cease our operations. If
we lose our rights to the intellectual property related to the RAP technology
purchased by us from BioMarin, our agreement with Roche regarding the evaluation
of therapeutic delivery across the blood-brain barrier utilizing NeuroTrans™
would likely be terminated and any milestone or royalty payments from Roche to
us would thereafter cease to accrue.
If we fail to
compete successfully with respect to acquisitions, joint venture and other
collaboration opportunities, we may be limited in our ability to develop our
drug product candidates.
Our competitors compete with us to
attract established biotechnology and pharmaceutical companies or organizations
for acquisitions, joint ventures, licensing arrangements or other
collaborations. Collaborations include licensing proprietary technology from,
and other relationships with, academic research institutions. If our competitors
successfully enter into partnering arrangements or license agreements with
academic research institutions, we will then be precluded from pursuing those
specific opportunities. Since each of these opportunities is unique, we may not
be able to find a substitute. Other companies have already begun many drug
development programs, which may target diseases that we are also targeting, and
have already entered into partnering and licensing arrangements with academic
research institutions, reducing the pool of available
opportunities.
Universities and public and private
research institutions also compete with us. While these organizations primarily
have educational or basic research objectives, they may develop proprietary
technology and acquire patents that we may need for the development of our drug
product candidates. We will attempt to license this proprietary technology, if
available. These licenses may not be available to us on acceptable terms, if at
all. If we are unable to compete successfully with respect to acquisitions,
joint venture and other collaboration opportunities, we may be limited in our
ability to develop new products.
If we do not
achieve our projected development goals in the time frames we announce and
expect, the credibility of our management and our technology may be adversely
affected and, as a result, the price of our common stock may
decline.
For planning purposes, we estimate the
timing of the accomplishment of various scientific, clinical, regulatory and
other product development goals, which we sometimes refer to as milestones.
These milestones may include the commencement or completion of scientific
studies and clinical trials and the submission of regulatory
filings.
From time to time, we may publicly
announce the expected timing of some of these milestones. All of these
milestones will be based on a variety of assumptions. The actual timing of these
milestones can vary dramatically compared to our estimates, in many cases for
reasons beyond our control. If we do not meet these milestones as publicly
announced, our stockholders may lose confidence in our ability to meet these
milestones and, as a result, the price of our common stock may
decline.
S-13
Our product
development programs will require substantial additional future funding which
could impact our operational and financial condition.
It will take several years before we
are able to develop marketable drug product candidates, if at all. Our product
development programs will require substantial additional capital to successfully
complete them, arising from costs to:
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conduct
research, preclinical testing and human studies;
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establish
pilot scale and commercial scale manufacturing processes and facilities;
and
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establish
and develop quality control, regulatory, marketing, sales, finance and
administrative capabilities to support these
programs.
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Our future operating and capital needs
will depend on many factors, including:
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the
pace of scientific progress in our research and development programs and
the magnitude of these programs;
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the
scope and results of preclinical testing and human clinical
trials;
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our
ability to obtain, and the time and costs involved in obtaining regulatory
approvals;
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our
ability to prosecute, maintain, and enforce, and the time and costs
involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims;
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competing
technological and market developments;
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our
ability to establish additional collaborations;
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changes
in our existing collaborations;
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the
cost of manufacturing scale-up; and
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the
effectiveness of our commercialization
activities.
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We base our outlook regarding the need
for funds on many uncertain variables. Such uncertainties include the success of
our research initiatives, regulatory approvals, the timing of events outside our
direct control such as negotiations with potential strategic partners and other
factors. Any of these uncertain events can significantly change our cash
requirements as they determine such one-time events as the receipt or payment of
major milestones and other payments.
Significant additional funds will be
required to support our operations and if we are unable to obtain them on
favorable terms, we may be required to cease or reduce further development or
commercialization of our drug product programs, to sell some or all of our
technology or assets, to merge with another entity or cease
operations.
Uncertainties
regarding healthcare reform and third-party reimbursement may impair our ability
to raise capital, form collaborations and if any of our product candidates
become marketable, sell such products.
The continuing efforts of governmental
and third-party payers to contain or reduce the costs of healthcare through
various means may harm our business. For example, in some foreign markets, the
pricing or profitability of healthcare products is subject to government
control. In the United States, there have been, and we expect there will
continue to be, a number of federal and state proposals to implement similar
government control. The implementation or even the announcement of any of these
legislative or regulatory proposals or reforms could harm our business if any of
our product candidates become marketable by reducing the prices we or our
partners are able to charge for our products (if marketable), impeding our
ability to achieve profitability, raise capital or form
collaborations. In addition, the availability of reimbursement from
third-party payers determines, in large part, the demand for healthcare products
in the United States and elsewhere. Examples of such third-party payers are
government and private insurance plans. Significant uncertainty exists as to the
reimbursement status of newly approved healthcare products and third-party
payers are increasingly challenging the prices charged for medical products and
services. If we succeed in bringing one or more products to the market,
reimbursement from third-party payers may not be available or may not be
sufficient to allow us to sell such products on a competitive or profitable
basis.
S-14
If we fail to
demonstrate efficacy in our preclinical studies and clinical trials our future
business prospects, financial condition and operating results will be materially
adversely affected.
The success of our development and
commercialization efforts will be greatly dependent upon our ability to
demonstrate drug product candidate efficacy in preclinical studies, as well as
in clinical trials. Preclinical studies involve testing drug product candidates
in appropriate non-human disease models to demonstrate efficacy and safety.
Regulatory agencies evaluate these data carefully before they will approve
clinical testing in humans. If certain preclinical data reveals potential safety
issues or the results are inconsistent with an expectation of the drug product
candidate’s efficacy in humans, the regulatory agencies may require additional
more rigorous testing, before allowing human clinical trials. This additional
testing will increase program expenses and extend timelines. We may decide to
suspend further testing on our drug product candidates or technologies if, in
the judgment of our management and advisors, the preclinical test results do not
support further development.
Moreover, success in preclinical
testing and early clinical trials does not ensure that later clinical trials
will be successful, and we cannot be sure that the results of later clinical
trials will replicate the results of prior clinical trials and preclinical
testing. The clinical trial process may fail to demonstrate that our drug
product candidates are safe for humans and effective for indicated uses. This
failure would cause us to abandon a drug product candidate and may delay
development of other drug product candidates. Any delay in, or termination of,
our preclinical testing or clinical trials will delay the filing of our
investigational new drug application, or IND, and new drug application, or NDA,
as applicable, with the FDA and, ultimately, our ability to commercialize our
drug product candidates and generate product revenues. In addition, some of our
clinical trials will involve small patient populations. Because of the small
sample size, the results of these early clinical trials may not be indicative of
future results. Following successful preclinical testing, drug product
candidates will need to be tested in a clinical development program to provide
data on safety and efficacy prior to becoming eligible for product approval and
licensure by regulatory agencies. From first clinical trial through product
approval can take at least eight years, on average in the U.S.
If any of our future clinical
development drug product candidates become the subject of problems, including
those related to, among others:
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efficacy
or safety concerns with the drug product candidates, even if not
justified;
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unexpected
side-effects;
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regulatory
proceedings subjecting the drug product candidates to potential
recall;
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publicity
affecting doctor prescription or patient use of the drug product
candidates;
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pressure
from competitive products; or
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introduction
of more effective treatments,
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our
ability to sustain our development programs will become critically compromised.
For example, efficacy or safety concerns may arise, whether or not justified,
that could lead to the suspension or termination of our clinical
programs.
Each clinical phase is designed to test
attributes of drug product candidates and problems that might result in the
termination of the entire clinical plan can be revealed at any time throughout
the overall clinical program. The failure to demonstrate efficacy in our
clinical trials would have a material adverse effect on our future business
prospects, financial condition and operating results.
If we do not
obtain the support of new, and maintain the support of existing, key scientific
collaborators, it may be difficult to establish products using our technologies
as a standard of care for various indications, which may limit our revenue
growth and profitability and could have a material adverse effect on our
business, prospects, financial condition and operating
results.
We will need to establish relationships
with additional leading scientists and research institutions. We believe that
such relationships are pivotal to establishing products using our technologies
as a standard of care for various indications. Although we have established a
Medical and Scientific Advisory Board and research collaborations, there is no
assurance that our Advisory Board members and our research collaborators will
continue to work with us or that we will be able to attract additional research
partners. If we are not able to maintain existing or establish new scientific
relationships to assist in our research and development, we may not be able to
successfully develop our drug product candidates.
S-15
If the
manufacturers upon whom we rely fail to produce in the volumes and quality that
we require on a timely basis, or to comply with stringent regulations applicable
to pharmaceutical manufacturers, we may face delays in the development and
commercialization of, or be unable to meet demand for, our products, if any, and
may lose potential revenues.
We do not currently manufacture our
drug product candidates, and does not currently plan to develop the capacity to
do so. The manufacture of pharmaceutical products requires significant expertise
and capital investment, including the development of advanced manufacturing
techniques and process controls. Manufacturers of pharmaceutical products often
encounter difficulties in production, particularly in scaling up initial
production. These problems include difficulties with production costs and
yields, quality control, including stability of the product candidate and
quality assurance testing, shortages of qualified personnel, as well as
compliance with strictly enforced federal, state and foreign regulations. Our
third-party manufacturers and key suppliers may experience manufacturing
difficulties due to resource constraints or as a result of labor disputes,
unstable political environments at foreign facilities or financial difficulties.
If these manufacturers or key suppliers were to encounter any of these
difficulties, or otherwise fail to comply with their contractual obligations,
our ability to timely launch any potential product candidate, if approved, would
be jeopardized.
In addition, all manufacturers and
suppliers of pharmaceutical products must comply with cGMP requirements enforced
by the FDA, through its facilities inspection program. The FDA is likely to
conduct inspections of our third party manufacturer and key supplier facilities
as part of their review of any of our NDAs. If our third party manufacturers and
key suppliers are not in compliance with cGMP requirements, it may result in a
delay of approval, particularly if these sites are supplying single source
ingredients required for the manufacture of any potential product. These cGMP
requirements include quality control, quality assurance and the maintenance of
records and documentation. Furthermore, regulatory qualifications of
manufacturing facilities are applied on the basis of the specific facility being
used to produce supplies. As a result, if a manufacturer for us shifts
production from one facility to another, the new facility must go through a
complete regulatory qualification and be approved by regulatory authorities
prior to being used for commercial supply. Our manufacturers may be unable to
comply with these cGMP requirements and with other FDA, state and foreign
regulatory requirements. A failure to comply with these requirements may result
in fines and civil penalties, suspension of production, suspension or delay in
product approval, product seizure or recall, or withdrawal of product approval.
If the safety of any quantities supplied is compromised due to a our third party
manufacturer’s or key supplier’s failure to adhere to applicable laws or for
other reasons, we may not be able to obtain regulatory approval for or
successfully commercialize our products.
If we fail to
obtain or maintain orphan drug exclusivity for some of our drug product
candidates, our competitors may sell products to treat the same conditions and
our revenues will be reduced.
As part of our business strategy, we
intend to develop some drugs that may be eligible for FDA and European Union, or
EU, orphan drug designation. Under the Orphan Drug Act, the FDA may designate a
product as an orphan drug if it is a drug intended to treat a rare disease or
condition, defined as a patient population of less than 200,000 in the U.S. The
company that first obtains FDA approval for a designated orphan drug for a given
rare disease receives marketing exclusivity for use of that drug for the stated
condition for a period of seven years. Orphan drug exclusive marketing rights
may be lost if the FDA later determines that the request for designation was
materially defective or if the manufacturer is unable to assure sufficient
quantity of the drug. Similar regulations are available in the EU with a 10-year
period of market exclusivity.
Because the extent and scope of patent
protection for some of our drug products is particularly limited, orphan drug
designation is especially important for our products that are eligible for
orphan drug designation. For eligible drugs, we plan to rely on the exclusivity
period under Orphan Drug Act designation to maintain a competitive position. If
we do not obtain orphan drug exclusivity for our drug products that do not have
patent protection, our competitors may then sell the same drug to treat the same
condition and our revenues will be reduced.
Even though we have obtained orphan
drug designation for DR Cysteamine for the potential treatment of nephropathic
cystinosis, the potential treatment of HD and the potential treatment of Batten
Disease and even if we obtain orphan drug designation for our future drug
product candidates, due to the uncertainties associated with developing
pharmaceutical products, we may not be the first to obtain marketing approval
for any orphan indication. Further, even if we obtain orphan drug exclusivity
for a product, that exclusivity may not effectively protect the product from
competition because different drugs can be approved for the same condition. Even
after an orphan drug is approved, the FDA can subsequently approve the same drug
for the same condition if the FDA concludes that the later drug is safer, more
effective or makes a major contribution to patient care. Orphan drug designation
neither shortens the development time or regulatory review time of a drug, nor
gives the drug any advantage in the regulatory review or approval
process.
S-16
The fast-track
designation for our drug product candidates, if obtained, may not actually lead
to a faster review process and a delay in the review process or in the approval
of our products will delay revenue from the sale of the products and will
increase the capital necessary to fund these product development
programs.
Although we have received Orphan Drug
Designations from the FDA as described above, our drug product candidates may
not receive an FDA fast-track designation or priority review. Without fast-track
designation, submitting an NDA and getting through the regulatory process to
gain marketing approval is a lengthy process. Under fast-track designation, the
FDA may initiate review of sections of a fast-track drug’s NDA before the
application is complete. However, the FDA’s time period goal for reviewing an
application does not begin until the last section of the NDA is submitted.
Additionally, the fast-track designation may be withdrawn by the FDA if the FDA
believes that the designation is no longer supported by data emerging in the
clinical trial process. Under the FDA policies, a drug candidate is eligible for
priority review, or review within a six-month time frame from the time a
complete NDA is accepted for filing, if the drug candidate provides a
significant improvement compared to marketed drugs in the treatment, diagnosis
or prevention of a disease. A fast-track designated drug candidate would
ordinarily meet the FDA’s criteria for priority review. The fast-track
designation for our drug product candidates, if obtained, may not actually lead
to a faster review process and a delay in the review process or in the approval
of our products will delay revenue from the sale of the products and will
increase the capital necessary to fund these product development
programs.
Because the
target patient populations for some of our products are small, we must achieve
significant market share and obtain high per-patient prices for our products to
achieve profitability.
Our clinical development of DR
Cysteamine targets diseases with small patient populations, including
nephropathic cystinosis and HD. If we are successful in developing DR Cysteamine
and receive regulatory approval to market DR Cysteamine for a disease with a
small patient population, the per-patient prices at which we could sell DR
Cysteamine for these indications are likely to be relatively high in order for
us to recover our development costs and achieve profitability. We believe that
we will need to market DR Cysteamine for these indications worldwide to achieve
significant market penetration of this product.
We may not be
able to market or generate sales of our products to the extent
anticipated.
Assuming that we are successful in
developing our drug product candidates and receive regulatory clearances to
market our products, our ability to successfully penetrate the market and
generate sales of those products may be limited by a number of factors,
including the following:
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Certain
of our competitors in the field have already received regulatory approvals
for and have begun marketing similar products in the U.S., the EU, Japan
and other territories, which may result in greater physician awareness of
their products as compared to ours.
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Information
from our competitors or the academic community indicating that current
products or new products are more effective than our future products
could, if and when it is generated, impede our market penetration or
decrease our future market share.
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Physicians
may be reluctant to switch from existing treatment methods, including
traditional therapy agents, to our future products.
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The
price for our future products, as well as pricing decisions by our
competitors, may have an effect on our revenues.
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Our
future revenues may diminish if third-party payers, including private
healthcare coverage insurers and healthcare maintenance organizations, do
not provide adequate coverage or reimbursement for our future
products.
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S-17
There are many
difficult challenges associated with developing proteins that can be used to
transport therapeutics across the blood-brain barrier.
Our RAP technology has a potential
clinical use as a drug transporter through the blood-brain barrier. However, we
do not know that our technology will work or work safely. Many groups and
companies have attempted to solve the critical medical challenge of developing
an efficient method of transporting therapeutic proteins from the blood stream
into the brain. Unfortunately, these efforts to date have met with little
success due in part to a lack of adequate understanding of the biology of the
blood-brain barrier and to the enormous scientific complexity of the transport
process itself. In the research and development of our RAP
technology, we will certainly face many of the same issues that have caused
these earlier attempts to fail. It is possible that:
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We
or our collaborator/licensee will not be able to produce enough RAP drug
product candidates for testing;
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the
pharmacokinetics, or where the drug distributes in the body, of our RAP
drug product candidates will preclude sufficient binding to the targeted
receptors on the blood-brain barrier;
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the
targeted receptors are not transported across the blood-brain
barrier;
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other
features of the blood-brain barrier, apart from the cells, block access
molecules to brain tissue after transport across the
cells;
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the
targeted receptors are expressed on the blood-brain barrier at densities
insufficient to allow adequate transport of our RAP drug product
candidates into the brain;
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targeting
of the selected receptors induces harmful side-effects which prevent their
use as drugs; or
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that
we or our collaborator/licensee’s RAP drug product candidates cause
unacceptable side-effects.
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Any of these conditions may preclude
the use of RAP or RAP fusion compounds from potentially treating diseases
affecting the brain.
If our
competitors succeed in developing products and technologies that are more
effective than our own, or if scientific developments change our understanding
of the potential scope and utility of our drug product candidates, then our
technologies and future drug product candidates may be rendered less
competitive.
We face significant competition from
industry participants that are pursuing similar technologies that we are
pursuing and are developing pharmaceutical products that are competitive with
our drug product candidates. Nearly all of our industry competitors have greater
capital resources, larger overall research and development staffs and
facilities, and a longer history in drug discovery and development, obtaining
regulatory approval and pharmaceutical product manufacturing and marketing than
we do. With these additional resources, our competitors may be able to respond
to the rapid and significant technological changes in the biotechnology and
pharmaceutical industries faster than we can. Our future success will depend in
large part on our ability to maintain a competitive position with respect to
these technologies. Rapid technological development, as well as new scientific
developments, may result in our compounds, drug product candidates or processes
becoming obsolete before we can recover any of the expenses incurred to develop
them. For example, changes in our understanding of the appropriate population of
patients who should be treated with a targeted therapy like we are developing
may limit the drug’s market potential if it is subsequently demonstrated that
only certain subsets of patients should be treated with the targeted
therapy.
Our reliance on
third parties, such as collaborators, university laboratories, contract
manufacturing organizations and contract or clinical research organizations, may
result in delays in completing, or a failure to complete, preclinical testing or
clinical trials if they fail to perform under our agreements with
them.
In the course of product development,
we may engage university laboratories, other biotechnology or companies or
contract or clinical manufacturing organizations to manufacture drug material
for us to be used in preclinical and clinical testing and collaborators and
contract or clinical research organizations to conduct and manage preclinical
studies and clinical trials. If we engage these organizations to help us with
our preclinical and clinical programs, many important aspects of this process
have been and will be out of our direct control. If any of these organizations
we may engage in the future fail to perform their obligations under our
agreements with them or fail to perform preclinical testing and/or clinical
trials in a satisfactory manner, we may face delays in completing our clinical
trials, as well as commercialization of any of our drug product candidates.
Furthermore, any loss or delay in obtaining contracts with such entities may
also delay the completion of our clinical trials, regulatory filings and the
potential market approval of our drug product candidates.
S-18
Companies and
universities that have licensed product candidates to us for research, clinical
development and marketing are sophisticated competitors that could develop
similar products to compete with our products which could reduce our future
revenues.
Licensing our product candidates from
other companies, universities or individuals does not always prevent them from
developing non-identical but competitive products for their own commercial
purposes, nor from pursuing patent protection in areas that are competitive with
us. While we seek patent protection for all of our owned and licensed product
candidates, our licensors or assignors who created these product candidates are
experienced scientists and business people who may continue to do research and
development and seek patent protection in the same areas that led to the
discovery of the product candidates that they licensed or assigned to us. By
virtue of the previous research that led to the discovery of the drugs or
product candidates that they licensed or assigned to us, these companies,
universities, or individuals may be able to develop and market competitive
products in less time than might be required to develop a product with which
they have no prior experience and may reduce our future revenues from such
product candidates.
Any
future product revenues could be reduced by imports from countries where our
product candidates are available at lower prices.
Even if we obtain FDA approval to
market our potential products in the United States, our sales in the United
States may be reduced if our products are imported into the United States from
lower priced markets, whether legally or illegally. In the United States, prices
for pharmaceuticals are generally higher than in the bordering nations of Canada
and Mexico. There have been proposals to legalize the import of pharmaceuticals
from outside the United States. If such legislation were enacted, our potential
future revenues could be reduced.
The use of any of
our drug product candidates in clinical trials may expose us to liability
claims.
The nature of our business exposes us
to potential liability risks inherent in the testing, manufacturing and
marketing of our drug product candidates. While we are in clinical stage
testing, our drug product candidates could potentially harm people or allegedly
harm people and we may be subject to costly and damaging product liability
claims. Some of the patients who participate in clinical trials are already
critically ill when they enter a trial. The waivers we obtain may not be
enforceable and may not protect us from liability or the costs of product
liability litigation. Although we currently carry a $3 million clinical product
liability insurance policy, it may not be sufficient to cover future claims. We
currently do not have any clinical or product liability claims or threats of
claims filed against us.
Our future
success depends, in part, on the continued service of our management
team.
Our success is dependent in part upon
the availability of our senior executive officers, including our Chief Executive
Officer, Dr. Christopher M. Starr, our Chief Scientific Officer, Dr. Todd C.
Zankel, our Chief Financial Officer, Kim R. Tsuchimoto, Ted Daley, the President
of our clinical development subsidiary and Dr. Patrice P. Rioux, Chief Medical
Officer of our clinical development subsidiary. The loss or unavailability to us
of any of these individuals or key research and development personnel, and
particularly if lost to competitors, could have a material adverse effect on our
business, prospects, financial condition, and operating results. We have no
key-man insurance on any of our employees. There is intense
competition for qualified scientists and managerial personnel from numerous
pharmaceutical and biotechnology companies, as well as from academic and
government organizations, research institutions and other entities. In addition,
we will rely on consultants and advisors, including scientific and clinical
advisors, to assist us in formulating our research and development strategy. All
of our consultants and advisors will be employed by other employers or be
self-employed, and will have commitments to or consulting or advisory contracts
with other entities that may limit their availability to us. There is no
assurance that we will be able to retain key employees and/or consultants. If
key employees terminate their employment, or if insufficient numbers of
employees are retained to maintain effective operations, our development
activities might be adversely affected, management’s attention might be diverted
from managing our operations to hiring suitable replacements, and our business
might suffer. In addition, we might not be able to locate suitable replacements
for any key employees that terminate, or that are terminated from, their
employment with us and we may not be able to offer employment to potential
replacements on reasonable terms, which could negatively impact our product
candidate development timelines and may adversely affect our future revenues and
financial condition.
S-19
Our success
depends on our ability to manage our growth.
If we are able to raise significant
additional financing, we expect to continue to grow, which could strain our
managerial, operational, financial and other resources. With the addition of our
clinical-stage programs and with our plan to in-license and acquire additional
clinical-stage product candidates, we will be required to retain experienced
personnel in the regulatory, clinical and medical areas over the next several
years. Also, as our preclinical pipeline diversifies through the acquisition or
in-licensing of new molecules, we will need to hire additional scientists to
supplement our existing scientific expertise over the next several
years.
Our staff, financial resources,
systems, procedures or controls may be inadequate to support our operations and
our management may be unable to take advantage of future market opportunities or
manage successfully our relationships with third parties if we are unable to
adequately manage our anticipated growth and the integration of new
personnel.
Our executive
offices and laboratory facility are located near known earthquake fault zones,
and the occurrence of an earthquake or other catastrophic disaster could cause
damage to our facility and equipment, or that of our third-party manufacturers
or single-source suppliers, which could materially impair our ability to
continue our product development programs.
Our executive offices and laboratory
facility are located in the San Francisco Bay Area near known earthquake fault
zones and are vulnerable to significant damage from earthquakes. We and the
third-party manufacturers with whom we contract and our single-source suppliers
of raw materials are also vulnerable to damage from other types of disasters,
including fires, floods, power loss and similar events. If any disaster were to
occur, our ability to continue our product development programs, could be
seriously, or potentially completely impaired. The insurance we maintain may not
be adequate to cover our losses resulting from disasters or other business
interruptions.
We will incur
increased costs as a result of recently enacted and proposed changes in laws and
regulations and our management will be required to devote substantial time to
comply with such laws and regulations.
We face burdens relating to the recent
trend toward stricter corporate governance and financial reporting standards.
Legislation or regulations such as Section 404 of the Sarbanes-Oxley Act of
2002, or the Sarbanes-Oxley Act, as well as other rules implemented by the SEC
and NASDAQ, follow the trend of imposing stricter corporate governance and
financial reporting standards have led to an increase in the costs of compliance
for companies similar to us, including increases in consulting, auditing and
legal fees. New rules could make it more difficult or more costly for us to
obtain certain types of insurance, including directors’ and officers’ liability
insurance, and we may be forced to accept reduced policy limits and coverage or
incur substantially higher costs to obtain the same or similar coverage. The
impact of these events could also make it more difficult for us to attract and
retain qualified persons to serve on our board of directors, our board
committees or as executive officers. Failure to comply with these new laws and
regulations may impact market perception of our financial condition and could
materially harm our business. Additionally, it is unclear what additional laws
or regulations may develop, and we cannot predict the ultimate impact of any
future changes in law. Our management and other personnel will need to devote a
substantial amount of time to these requirements.
In addition, the Sarbanes-Oxley Act
requires, among other things, that we maintain effective internal controls for
financial reporting and disclosure controls and procedures. In particular, we
must perform system and process evaluation and testing of our internal controls
over financial reporting to allow management to report on the effectiveness of
our internal controls over financial reporting, as required by Section 404 of
the Sarbanes-Oxley Act. Our compliance with Section 404 will require that we
incur substantial accounting and related expense and expend significant
management efforts. In the future, we may need to hire additional accounting and
financial staff to satisfy the ongoing requirements of Section 404. Moreover, if
we are not able to comply with the requirements of Section 404, or we or our
independent registered public accounting firm identifies deficiencies in our
internal controls over financial reporting that are deemed to be material
weaknesses, the market price of our stock could decline and we could be subject
to sanctions or investigations by NASDAQ, the SEC or other regulatory
authorities.
S-20
We may be
required to suspend, repeat or terminate our clinical trials if they do not meet
regulatory requirements, the results are negative or inconclusive, or if the
trials are not well designed, which may result in significant negative
repercussions on our business and financial condition.
Before regulatory approval for any
potential product can be obtained, we must undertake extensive clinical testing
on humans to demonstrate the tolerability and efficacy of the product, both on
our own terms, and as compared to the other principal drugs on the market that
have the same therapeutic indication. We cannot provide assurance that we will
obtain authorization to permit product candidates that are already in the
preclinical development phase to enter the human clinical testing phase. In
addition, we cannot provide assurance that any authorized preclinical or
clinical testing will be completed successfully within any specified time period
by us, or without significant additional resources or expertise to those
originally expected to be necessary. We cannot provide assurance that such
testing will show potential products to be safe and efficacious or that any such
product will be approved for a specific indication. Further, the results from
preclinical studies and early clinical trials may not be indicative of the
results that will be obtained in later-stage clinical trials. In addition, we or
regulatory authorities may suspend clinical trials at any time on the basis that
the participants are being exposed to unacceptable health risks.
Completion of clinical tests depends
on, among other things, the number of patients available for testing, which is a
function of many factors, including the number of patients with the relevant
conditions, the nature of the clinical testing, the proximity of patients to
clinical testing centers, the eligibility criteria for tests as well as
competition with other clinical testing programs involving the same patient
profile but different treatments. We will rely on third parties, such as
contract research organizations and/or co-operative groups, to assist us in
overseeing and monitoring clinical trials as well as to process the clinical
results and manage test requests, which may result in delays or failure to
complete trials, if the third parties fail to perform or to meet the applicable
standards. A failure by us or such third parties to keep to the terms of a
product program development for any particular product candidate or to complete
the clinical trials for a product candidate in the envisaged time frame could
have significant negative repercussions on our business and financial
condition.
If we fail to
establish and maintain collaborations or if our partners do not perform, we may
be unable to develop and commercialize our product candidates, which may
adversely affect our future revenues and financial
condition.
We have entered into collaborative
arrangements with third parties to develop and/or commercialize product
candidates. Additional collaborations might be necessary in order for us to fund
our research and development activities and third-party manufacturing
arrangements, seek and obtain regulatory approvals and successfully
commercialize existing and future product candidates. If we fail to maintain the
existing collaborative arrangements held by us or fail to enter into additional
collaborative arrangements, the number of product candidates from which we could
receive future revenues would decline.
Our dependence on collaborative
arrangements with third parties will subject us to a number of risks that could
harm our ability to develop and commercialize products:
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collaborative
arrangements might not be on terms favorable to us;
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disagreements
with partners may result in delays in the development and marketing of
products, termination of collaboration agreements or time consuming and
expensive legal action;
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we
cannot control the amount and timing of resources partners devote to
product candidates or their prioritization of product candidates, and
partners may not allocate sufficient funds or resources to the
development, promotion or marketing of our product candidates, or may not
perform their obligations as expected;
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partners
may choose to develop, independently or with other companies, alternative
products or treatments, including products or treatments which compete
with ours;
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agreements
with partners may expire or be terminated without renewal, or partners may
breach collaboration agreements with us;
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business
combinations or significant changes in a partner’s business strategy might
adversely affect that partner’s willingness or ability to complete their
obligations to us; and
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the
terms and conditions of the relevant agreements may no longer be
suitable.
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We cannot assure you that we will be
able to negotiate future collaboration agreements or that those currently in
existence will make it possible for us to fulfill our objectives.
S-21
We may not
complete our clinical trials in the time expected, which could delay or prevent
the commercialization of our products, which may adversely affect our future
revenues and financial condition.
Although for planning purposes we
forecast the commencement and completion of clinical trials, the actual timing
of these events can vary dramatically due to factors such as delays, scheduling
conflicts with participating clinicians and clinical institutions and the rate
of patient enrollment. Clinical trials involving our product candidates may not
commence nor be completed as forecasted. In certain circumstances we will rely
on academic institutions or clinical research organizations to conduct,
supervise or monitor some or all aspects of clinical trials involving our
product candidates. We will have less control over the timing and other aspects
of these clinical trials than if we conducted them entirely on our own. These
trials may not commence or be completed as we expect. They may not be conducted
successfully. Failure to commence or complete, or delays in, any of our planned
clinical trials could delay or prevent the commercialization of our product
candidates and harm our business and may adversely affect our future revenues
and financial condition.
If we fail to
keep pace with rapid technological change in the biotechnology and
pharmaceutical industries, our product candidates could become obsolete, which
may adversely affect our future revenues and financial
condition.
Biotechnology and related
pharmaceutical technology have undergone and are subject to rapid and
significant change. We expect that the technologies associated with
biotechnology research and development will continue to develop rapidly. Our
future will depend in large part on our ability to maintain a competitive
position with respect to these technologies. Any compounds, products or
processes that we develop may become obsolete before we recover any expenses
incurred in connection with developing such products, which may adversely affect
our future revenues and financial condition.
Risks Related to Our Intellectual
Property
If we are unable
to protect our proprietary technology, we may not be able to compete as
effectively and our business and financial prospects may be
harmed.
Where appropriate, we seek patent
protection for certain aspects of our technology. Patent protection may not be
available for some of the drug product candidates we are developing. If we must
spend significant time and money protecting our patents, designing around
patents held by others or licensing, potentially for large fees, patents or
other proprietary rights held by others, our business and financial prospects
may be harmed.
S-22
The patent
positions of biopharmaceutical products are complex and
uncertain.
We own or license patent applications
related to certain of our drug product candidates. However, these patent
applications do not ensure the protection of our intellectual property for a
number of reasons, including the following:
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We
do not know whether our patent applications will result in issued patents.
For example, we may not have developed a method for treating a disease
before others developed similar
methods.
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Competitors
may interfere with our patent process in a variety of ways. Competitors
may claim that they invented the claimed invention prior to us.
Competitors may also claim that we are infringing on their patents and
therefore cannot practice our technology as claimed under our patents, if
issued. Competitors may also contest our patents, if issued, by showing
the patent examiner that the invention was not original, was not novel or
was obvious. In litigation, a competitor could claim that our patents, if
issued, are not valid for a number of reasons. If a court agrees, we would
lose that patent. As a company, we have no meaningful experience with
competitors interfering with our patents or patent
applications.
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Enforcing
patents is expensive and may absorb significant time of our management.
Management would spend less time and resources on developing drug product
candidates, which could increase our operating expenses and delay product
programs.
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Receipt
of a patent may not provide much practical protection. If we receive a
patent with a narrow scope, then it will be easier for competitors to
design products that do not infringe on our patent.
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In
addition, competitors also seek patent protection for their technology.
Due to the number of patents in our field of technology, we cannot be
certain that we do not infringe on those patents or that we will not
infringe on patents granted in the future. If a patent holder believes our
drug product candidate infringes on its patent, the patent holder may sue
us even if we have received patent protection for our technology. If
someone else claims we infringe on their technology, we would face a
number of issues, including the following:
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Defending
a lawsuit takes significant time and can be very
expensive.
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If
a court decides that our drug product candidate infringes on the
competitor’s patent, we may have to pay substantial damages for past
infringement.
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A
court may prohibit us from selling or licensing the drug product candidate
unless the patent holder licenses the patent to us. The patent holder is
not required to grant us a license. If a license is available, we may have
to pay substantial royalties or grant cross licenses to our
patents.
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Redesigning
our drug product candidates so we do not infringe may not be possible or
could require substantial funds and
time.
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It is also unclear whether our trade
secrets are adequately protected. While we use reasonable efforts to protect our
trade secrets, our employees or consultants may unintentionally or willfully
disclose our information to competitors. Enforcing a claim that someone else
illegally obtained and is using our trade secrets, like patent litigation, is
expensive and time consuming, and the outcome is unpredictable. In addition,
courts outside the U.S. are sometimes less willing to protect trade secrets. Our
competitors may independently develop equivalent knowledge, methods and
know-how. We may also support and collaborate in research
conducted by government organizations, hospitals, universities or other
educational institutions. These research partners may be unwilling to grant us
any exclusive rights to technology or products derived from these collaborations
prior to entering into the relationship. If we do not obtain required licenses
or rights, we could encounter delays in our product development efforts while we
attempt to design around other patents or even be prohibited from developing,
manufacturing or selling drug product candidates requiring these licenses. There
is also a risk that disputes may arise as to the rights to technology or drug
product candidates developed in collaboration with other parties.
S-23
If our agreements
with employees, consultants, advisors and corporate partners fail to protect our
intellectual property, proprietary information or trade secrets, it could have a
significant adverse effect on us.
We have taken steps to protect our
intellectual property and proprietary technology, by entering into
confidentiality agreements and intellectual property assignment agreements with
our employees, consultants, advisors and corporate partners. Such agreements may
not be enforceable or may not provide meaningful protection for our trade
secrets or other proprietary information in the event of unauthorized use or
disclosure or other breaches of the agreements, and we may not be able to
prevent such unauthorized disclosure. Monitoring unauthorized disclosure is
difficult, and we do not know whether the steps we have taken to prevent such
disclosure are, or will be, adequate. Furthermore, the laws of some foreign
countries may not protect our intellectual property rights to the same extent as
do the laws of the United States.
Risks Related to Our Common
Stock
There
are a substantial number of shares of our common stock eligible for future sale
in the public market, and the issuance or sale of equity, convertible or
exchangeable securities in the market, or the perception of such future sales or
issuances, could lead to a decline in the trading price of our common
stock.
Any issuance of equity, convertible or
exchangeable securities, including for the purposes of financing acquisitions
and the expansion of our business, may have a dilutive effect on our existing
stockholders. In addition, the perceived risk associated with the possible
issuance of a large number of shares of our common stock or securities
convertible or exchangeable into a large number of shares of our common stock
could cause some of our stockholders to sell their common stock, thus causing
the trading price of our common stock to decline. Subsequent sales of our common
stock in the open market or the private placement of our common stock or
securities convertible or exchangeable into our common stock could also have an
adverse effect on the trading price of our common stock. If our common stock
price declines, it may be more difficult for us to or we may be unable to raise
additional capital.
In addition, future sales of
substantial amounts of our currently outstanding common stock in the public
market, or the perception that such sales could occur, could adversely affect
prevailing trading prices of our common stock, and could impair our ability to
raise capital through future offerings of equity or equity-related securities.
We cannot predict what effect, if any, future sales of our common stock, or the
availability of shares for future sales, will have on the trading price of our
common stock.
In May and June 2008, prior to our
merger with Raptor Pharmaceuticals Corp. in 2009, pursuant to a securities
purchase agreement for a private placement of units, Raptor Pharmaceuticals
Corp. issued to investors in such private placement, 20,000,000 shares of its
common stock and two-year warrants to purchase up to, in the aggregate,
10,000,000 shares of its common stock and to placement agents in such private
placement, five-year warrants to purchase up to, in the aggregate, 2,100,000
shares of its common stock. On a post-merger basis, the 20,000,000
shares of Raptor Pharmaceuticals Corp.’s common stock, the two-year warrants to
purchase up to, in the aggregate, 10,000,000 shares of Raptor Pharmaceuticals
Corp.’s common stock and the five-year warrants to purchase up to, in the
aggregate, 2,100,000 shares of Raptor Pharmaceuticals Corp.’s common stock,
respectively, would be 4,662,468 shares of our common stock, two-year warrants
to purchase up to, in the aggregate, 2,331,234 shares of our common stock and
the five-year warrants to purchase up to, in the aggregate, 489,559 shares of
our common stock, respectively. In April 2009, in order to reflect
then-current market prices, Raptor Pharmaceuticals Corp. notified the holders of
warrants purchased in the May/June 2008 private placement that it was offering,
in exchange for such warrants, new warrants to purchase its common stock at an
exercise price of $0.30 per share, but only to the extent such exchange of the
original warrants and exercise of the new warrants, including the delivery of
the exercise price, occurred on or prior to July 17, 2009. The warrants that
were not exchanged prior to or on July 17, 2009 retained their original exercise
prices of $0.90 per share and original expiration date of May 21,
2010. On a post-merger basis, the warrants that were not exchanged
prior to or on July 17, 2009 would be warrants to purchase shares of our common
stock at an exercise price of $3.86 per share and would continue to have an
expiration date of May 21, 2010. Raptor Pharmaceuticals Corp.
received approximately $2.6 million of proceeds from warrant exercises that
resulted in the issuance of 8,715,000 shares of its common stock pursuant to the
exchange described above. On a post-merger basis, the 8,715,000 shares of Raptor
Pharmaceuticals Corp.’s common stock would be 2,031,670 shares of our common
stock. In August 2009, pursuant to a securities purchase agreement for a private
placement of units, Raptor Pharmaceuticals Corp. issued to investors in such
private placement, 7,456,250 shares of its common stock and two-year warrants to
purchase up to, in the aggregate, 3,728,125 shares of its common stock and to
placement agents in such private placement, a five-year warrant to purchase up
to, in the aggregate, 556,500 shares of its common stock. On a
post-merger basis, the 7,456,250 shares of Raptor Pharmaceuticals Corp.’s common
stock, the two-year warrants to purchase up to, in the aggregate, 3,728,125
shares of Raptor Pharmaceuticals Corp.’s common stock and the five-year warrants
to purchase up to, in the aggregate, 556,500 shares of Raptor Pharmaceuticals
Corp.’s common stock, respectively, would be 1,738,226 shares of our common
stock, two-year warrants to purchase up to, in the aggregate, 869,113 shares of
our common stock and the five-year warrants to purchase up to, in the aggregate,
129,733 shares of our common stock, respectively. These stock
issuances and other future issuances of common stock underlying unexpired and
unexercised warrants have and will result in, significant dilution to our
stockholders. In connection with other collaborations, joint
ventures, license agreements or future financings that we may enter into in the
future, we may issue additional shares of common stock or other equity
securities, and the value of the securities issued may be substantial and create
additional dilution to our existing and future common stockholders.
S-24
There were 18,831,957 shares of our
common stock outstanding as of December 17, 2009. We also had outstanding as of
December 17, 2009 warrants that are exercisable to purchase an aggregate of
2,020,793 shares of our common stock at a weighted average exercise price of
$3.07 per share. On October 13, 2009, we filed a registration statement
registering the resale of up to an aggregate of 5,557,865 shares of our common
stock (including common stock issuable under warrants). Such
registration statement was declared effective by the SEC on November 12,
2009.
In addition to our outstanding
warrants, as of December 17, 2009, there were (i) options to purchase
1,025,566 shares of our common stock outstanding under our 2006 Raptor
Pharmaceutical Equity Incentive Plan at a weighted-average exercise price of
$2.46, (ii) options to purchase 161,044 shares of our common stock
outstanding under our 2006 TorreyPines Therapeutics Equity Incentive Plan at a
weighted-average exercise price of $125.36, (iii) 367,679 shares of our common
stock available for issuance under our 2006 Raptor Pharmaceutical Equity
Incentive Plan (of which all such shares are subject to approval by our
stockholders at our 2010 Annual Meeting of stockholders) and (iv) 855,116 shares
of our common stock available for issuance under our 2006 TorreyPines
Therapeutics Equity Incentive Plan. The shares issuable under our
equity incentive plans will be available for immediate resale in the public
market. The shares issuable under the warrants are available for immediate
resale in the public market. The market price of our common stock could decline
as a result of such resales due to the increased number of shares available for
sale in the market.
Our executive officers and directors
will be subject to the lock-up agreements described in “Plan of Distribution”
for a period of 90 days after the date of this prospectus supplement,
representing approximately 1,728,022 shares, or 7.7% of our outstanding common
stock after this offering (taking into account the 3,747,558 shares of common
stock that are expected to be sold in this offering). Following the termination
of these lock-up periods, these stockholders will have the ability to sell a
substantial number of shares of common stock in the public market in a short
period of time. Sales of a substantial number of shares of common stock in the
public trading market, whether in a single transaction or a series of
transactions, or the perception that these sales may occur, could also have a
significant effect on volatility and the trading price of our common
stock.
We are obligated
to issue additional common stock based on our contractual obligations, if we
meet certain triggering events, if at all. When we issue such additional common
stock, this will result in dilution to common stockholders at the time such
additional common stock is issued.
Future milestone payments, as more
fully set forth under “Contractual Obligations with Thomas E. Daley (as assignee
of the dissolved Convivia, Inc.)” and “Contractual Obligations with Former
Encode Securityholders” discussed in certain of our periodic filings with the
SEC relating to our acquisition of the Convivia assets and merger with Encode
will result in dilution. We may be required to make additional contingent
payments of up to 664,400 shares of our common stock, in the aggregate, under
the terms of our acquisition of Convivia assets and merger with Encode, based on
milestones related to certain future marketing and development approvals
obtained with respect to Convivia and Encode product candidates. The issuance of
any of these shares will result in further dilution to our existing
stockholders.
Because
we do not intend to pay any cash dividends on our common stock, investors will
benefit from an investment in our common stock only if it appreciates in
value. Investors seeking dividend income or liquidity should not
purchase shares of our common stock.
We have not declared or paid any cash
dividends on our common stock since our inception. We anticipate that
we will retain our future earnings, if any, to support our operations and to
finance the growth and development of our business and do not expect to pay cash
dividends in the foreseeable future. As a result, the success of an investment
in our common stock will depend upon any future appreciation in the value of our
common stock. There is no guarantee that our common stock will appreciate in
value or even maintain its current price. Investors seeking dividend
income or liquidity should not invest in our common stock.
S-25
Our stock price
is volatile, which could result in substantial losses for our stockholders, and
the trading in our common stock may be limited.
Our common stock is quoted on The
Nasdaq Capital Market. The trading price of our common stock has been and may
continue to be volatile. Our operating performance will significantly affect the
market price of our common stock. To the extent we are unable to compete
effectively and gain market share or the other factors described in this “Risk
Factors” section (or the “Risk Factors” sections of our periodic reports that we
file with the SEC that are incorporated by reference herein) affect us, our
stock price will likely decline. The market price of our common stock also may
be adversely impacted by broad market and industry fluctuations regardless of
our operating performance, including general economic and technology trends. The
Nasdaq Capital Market has, from time to time, experienced extreme price and
trading volume fluctuations, and the market prices of biopharmaceutical
development companies such as ours have been extremely
volatile. Market prices for securities of early-stage pharmaceutical,
biotechnology and other life sciences companies have historically been
particularly volatile and trading in such securities has often been limited.
Some of the factors that may cause the market price of our common stock to
fluctuate include:
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results of our current and any future clinical trials of our drug
candidates;
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the
results of ongoing preclinical studies and planned clinical trials of our
preclinical drug candidates;
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the
entry into, or termination of, key agreements, including key strategic
alliance agreements;
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the
results and timing of regulatory reviews relating to the approval of our
drug candidates;
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the
initiation of, material developments in, or conclusion of litigation to
enforce or defend any of our intellectual property
rights;
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failure
of any of our drug candidates, if approved, to achieve commercial
success;
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general
and industry-specific economic conditions that may affect our research and
development expenditures;
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the
results of clinical trials conducted by others on drugs that would compete
with our drug candidates;
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issues
in manufacturing our drug candidates or any approved
products;
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the
loss of key employees;
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the
introduction of technological innovations or new commercial products by
our competitors;
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Changes
in estimates or recommendations by securities analysts, if any, who cover
our common stock;
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future
sales of our common stock;
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Changes
in the structure of health care payment systems; and
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period-to-period
fluctuations in our financial
results.
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Moreover, the stock markets in general
have experienced substantial volatility that has often been unrelated to the
operating performance of individual companies. These broad market fluctuations
may also adversely affect the trading price of our common stock. In
the past, following periods of volatility in the market price of a company’s
securities, stockholders have often instituted class action securities
litigation against those companies. Such litigation can result in substantial
costs and diversion of management attention and resources, which could
significantly harm our profitability and reputation.
S-26
Our stock is a
penny stock. Trading of our stock may be restricted by the SEC’s penny stock
regulations and the FINRA’s sales practice requirements, which may limit a
stockholder’s ability to buy and sell our stock.
Our common stock is a penny stock. The
SEC has adopted Rule 15g-9 which generally defines “penny stock” to be any
equity security that has a market price less than $5.00 per share or an exercise
price of less than $5.00 per share, subject to certain exceptions. Our
securities are covered by the penny stock rules, which impose additional sales
practice requirements on broker-dealers who sell to persons other than
established customers and institutional accredited investors. The penny stock
rules require a broker-dealer, prior to a transaction in a penny stock not
otherwise exempt from the rules, to deliver a standardized risk disclosure
document in a form prepared by the SEC which provides information about penny
stocks and the nature and level of risks in the penny stock market. The
broker-dealer also must provide the customer with current bid and offer
quotations for the penny stock, the compensation of the broker-dealer and its
salesperson in the transaction and monthly account statements showing the market
value of each penny stock held in the customer’s account. The bid and offer
quotations, and the broker-dealer and salesperson compensation information, must
be given to the customer orally or in writing prior to effecting the transaction
and must be given to the customer in writing before or with the customer’s
confirmation. In addition, the penny stock rules require that prior to a
transaction in a penny stock not otherwise exempt from these rules, the
broker-dealer must make a special written determination that the penny stock is
a suitable investment for the purchaser and receive the purchaser’s written
agreement to the transaction. These disclosure requirements may have the effect
of reducing the level of trading activity in the secondary market for the stock
that is subject to these penny stock rules. Consequently, these penny stock
rules may affect the ability of broker-dealers to trade our securities. We
believe that the penny stock rules discourage investor interest in and limit the
marketability of our common stock.
In addition to the “penny stock” rules
promulgated by the SEC, the Financial Industry Regulatory Authority, or FINRA,
has adopted rules that require that in recommending an investment to a customer,
a broker-dealer must have reasonable grounds for believing that the investment
is suitable for that customer. Prior to recommending speculative low priced
securities to their non-institutional customers, broker-dealers must make
reasonable efforts to obtain information about the customer’s financial status,
tax status, investment objectives and other information. Under interpretations
of these rules, the FINRA believes that there is a high probability that
speculative low priced securities will not be suitable for at least some
customers. The FINRA requirements make it more difficult for broker-dealers to
recommend that their customers buy our common stock, which may limit your
ability to buy and sell our stock.
An adverse
determination, if any, in the class action suit in which we are a defendant, or
our inability to obtain or maintain directors’ and officers’ liability
insurance, could have a material adverse affect on us.
A class action securities lawsuit was
filed against us, as described in the section titled, “Legal Proceedings” in
certain of our periodic reports that we file with the SEC. We are defending
against this action vigorously; however, we do not know what the outcome of the
proceedings will be and, if we do not prevail, we may be required to pay
substantial damages or settlement amounts. Furthermore, regardless of the
outcome, we may incur significant defense costs, and the time and attention of
our key management may be diverted from normal business operations. If we are
ultimately required to pay significant defense costs, damages or settlement
amounts, such payments could materially and adversely affect our operations and
results. We have purchased liability insurance, however, if any costs or
expenses associated with the litigation exceed the insurance coverage, we may be
forced to bear some or all of these costs and expenses directly, which could be
substantial and may have an adverse effect on our business, financial condition,
results of operations and cash flows. In any event, publicity surrounding the
lawsuits and/or any outcome unfavorable to us could adversely affect our
reputation and stock price. The uncertainty associated with substantial
unresolved lawsuits could harm our business, financial condition and
reputation. We have certain obligations to indemnify our
officers and directors and to advance expenses to such officers and directors.
Although we have purchased liability insurance for our directors and officers,
if our insurance carriers should deny coverage, or if the indemnification costs
exceed the insurance coverage, we may be forced to bear some or all of these
indemnification costs directly, which could be substantial and may have an
adverse effect on our business, financial condition, results of operations and
cash flows. If the cost of the liability insurance increases significantly, or
if this insurance becomes unavailable, we may not be able to maintain or
increase our levels of insurance coverage for our directors and officers, which
could make it difficult to attract or retain qualified directors and
officers.
S-27
We
can issue shares of preferred stock that may adversely affect the rights of a
stockholder of our common stock.
Our certificate of incorporation
authorizes us to issue up to 15,000,000 shares of preferred stock with
designations, rights and preferences determined from time-to-time by our board
of directors. Accordingly, our board of directors is empowered, without
stockholder approval, to issue preferred stock with dividend, liquidation,
conversion, voting or other rights superior to those of stockholders of our
common stock.
Anti-takeover
provisions in our stockholder rights plan and in our certificate of
incorporation and bylaws may prevent or frustrate attempts by stockholders to
change the board of directors or current management and could make a third-party
acquisition of us difficult.
We are a party to a stockholder rights
plan, also referred to as a poison pill, which is intended to deter a hostile
takeover of us by making such proposed acquisition more expensive and less
desirable to the potential acquirer. The stockholder rights plan and our
certificate of incorporation and bylaws, as amended, contain provisions that may
discourage, delay or prevent a merger, acquisition or other change in control
that stockholders may consider favorable, including transactions in which
stockholders might otherwise receive a premium for their shares. These
provisions could limit the price that investors might be willing to pay in the
future for shares of our common stock.
Management
may invest or spend the proceeds of this offering in ways with which you may not
agree and in ways that may not yield a return to our stockholders.
We will retain broad discretion over
the use of proceeds from this offering. We expect to use the net proceeds from
this offering to fund our research and development efforts and for general
corporate purposes, including working capital. A number of variables will
influence our actual use of the proceeds from this offering, and our actual uses
of the proceeds of this offering may vary substantially from our currently
planned uses. Management could choose to spend the net proceeds from this
offering in ways in which stockholders may not deem desirable, or in ways that
do not improve our operating results or result in a significant return or any
return at all for our stockholders.
New
investors in our common stock could experience immediate and substantial
dilution.
The offering price of our common stock
could be substantially higher than what the net tangible book value per share of
our common stock is at the time of any offering. As a result, investors of
our common stock in this offering could incur immediate and substantial
dilution. For example, assuming the full 3,747,558 units that are the
subject of this offering are sold at a price to the public of $2.00 per share,
the investors would experience immediate dilution of approximately $1.54 per
share. Those investors could experience additional dilution upon the
exercise of outstanding stock options having an exercise price less than the per
share offering price to the public in this offering. See “Dilution”
for a more detailed discussion of the dilution new investors will incur in this
offering.
No
trading market for the warrants is expected to develop.
Although
the warrants being offered hereby are registered for public sale, they will not
be listed on The Nasdaq Capital Market or any other exchange and we do not
expect a trading market for the warrants to develop. As a result,
your ability to sell or otherwise transfer your warrants may be
limited.
S-28
The net proceeds from this offering,
after deducting the placement agent’s fees and our estimated expenses, will be
approximately $6.9 million, based on a public offering price of $2.00 per
share. We expect to use the net proceeds from the offering to fund
part of our capital expenditure program and for other corporate
purposes. In this regard, we may use the net proceeds of this
offering to fund our research and development efforts, including clinical trials
for our drug candidates, and for general corporate purposes, including working
capital. The amounts and timing of these expenditures will depend on a number of
factors, such as the timing and progress of our research and development
efforts, technological advances and the competitive environment for our drug
candidates. Pending these uses, we intend to invest the net proceeds in
investment-grade, interest-bearing securities.
DETERMINATION
OF OFFERING PRICE
The last reported sale price of our
common stock on the Nasdaq Capital Market on December 17, 2009 was $2.45 per
share and the price of the units (up to 3,747,558) we are selling in this
offering is $2.00 per unit (each unit, which is comprised of one share, one
Series A Warrant to purchase 0.5 of a share of our common stock and one Series B
Warrant to purchase 0.5 of a share of our common stock). This
negotiated offering price was principally determined through negotiations among
us, the placement agent and the investors. The Warrants have a term
of five years and eighteen (18) months, respectively, to purchase up to, in the
aggregate, 1,873,779 shares of our common stock at an exercise price of $2.45
per share.
The principal factors considered in
determining the public offering price, and the terms and conditions of the
securities purchase agreement, placement agent agreement and Warrants
include:
|
·
|
the
market price and volatility of our common
stock;
|
|
·
|
our
need to obtain financing in an efficient and expeditious manner in order
to fund our operations and research and development programs and their
related costs;
|
|
·
|
the
immediate and substantial dilution of investors in this
offering;
|
|
·
|
the
information set forth in this prospectus supplement and accompanying
prospectus and otherwise available to the placement agent and
investors;
|
|
·
|
our
history and prospects and the history of, and prospects for, the industry
in which we compete;
|
|
·
|
our
past and present financial
performance;
|
|
·
|
our
prospects for future earnings and the present state of our
development;
|
|
·
|
the
general condition of the securities markets at the time of this
offering;
|
|
·
|
the
recent market prices of, and demand for, publicly traded common stock of
generally comparable companies; and
|
|
·
|
other
factors deemed relevant by the placement agent, investors and
us.
|
S-29
If you purchase units from us, your
interest will be diluted to the extent of the difference between the offering
price per share you pay and the net tangible book value per share of our common
stock immediately after the completion of the offering. Our net tangible book
value as of August 31, 2009, was $3.0 million, or $0.17 per share of common
stock. Net tangible book value per share is calculated by subtracting our total
liabilities from our total tangible assets, which is total assets less
intangible assets of $2,524,792, and dividing this amount by the number of
shares of common stock outstanding as of August 31, 2009. Assuming the sale by
us of all 3,747,558 units offered hereby at the offering price of $2.00 per unit
(and assuming a value per share of common stock offered in each unit of $2.00
per share and attributing no value to the warrants included in each unit), and
after deducting the estimated fees and offering expenses payable by us, our
adjusted net tangible book value as of August 31, 2009 would have been
approximately $9.9 million, or $0.46 per share of common stock. This would
represent an immediate increase in the net tangible book value of $0.29 per
share to our existing stockholders and an immediate and substantial dilution in
the pro forma net tangible book value of $1.54 per share of common stock to new
investors. The following table illustrates this calculation on a per share
basis:
Assumed
public offering price per share included in each unit
|
|
|
|
$
|
2.00
|
|
Net
tangible book value per share as of August 31,
2009
|
|
0.17
|
|
|
|
Increase
per share attributable to new investors
|
|
0.29
|
|
|
|
As
adjusted net tangible book value per share after the
offering
|
|
|
|
0.46
|
|
Net
dilution per share to new investors
|
|
|
|
$
|
1.54
|
|
Investors that purchase common stock
upon exercise of warrants offered hereby may experience dilution depending on
our net tangible book value at the time of exercise.
The information in the table above is
provided for illustrative purposes and assumes that all of the units offered
hereby in the aggregate amount of 3,747,558 are sold at a price of $2.00 per
share. An increase, or decrease, of $1.00 per share in the price at which the
shares are sold from the assumed offering price of $2.00 per share shown in the
table above, assuming all of the units in the aggregate amount of 3,747,558 are
sold at that price, would increase (or decrease) our adjusted net tangible book
value after the offering by $3,747,558 or $0.06 per share, respectively, and the
dilution in net tangible book value per share for new investors in this offering
by $(0.93), after deducting the estimated fees of the placement agent and
estimated aggregate offering expenses payable by us.
The information above and in the
foregoing table is based upon 17,857,555 shares of our common stock outstanding
as of August 31, 2009. The information above and in the foregoing
table excludes:
|
·
1,186,610 shares of our common stock issuable upon the exercise of options
outstanding under our stock option plans at a weighted average exercise
price of $19.14 per share;
|
|
·
1,222,795 shares of our common stock available for future issuance
under our stock option plans;
|
|
·
2,020,793 shares of our common stock issuable upon exercise of
various outstanding warrants at a weighted average exercise price of $3.07
per share;
|
|
·
any shares deemed issued as result of the merger with Raptor
Pharmaceuticals Corp.;
|
|
·
Up to 3,747,558 shares of common stock issuable upon the exercise
of the Warrants issued hereunder;
|
|
·
Up to 74,951 shares of common stock issuable upon the exercise of
warrants issued to the placement agent as described in this prospectus
supplement;
|
|
·
7,680 shares issued pursuant to an exercised warrant;
and
|
|
·
2,115 shares issued pursuant to an exercised
option.
|
S-30
The following table sets forth our cash
and cash equivalents and our capitalization as of August 31,
2009:
|
•
|
|
on
an actual basis; and
|
|
•
|
|
on
an as adjusted basis to give effect to this offering (assuming
approximately 3,747,558 shares of our common stock are sold in this
offering at an assumed public offering price of $2.00 per share, but
excluding the 3,747,558 shares of common stock issuable upon the exercise
of the Warrants issued to the investors and excluding the 74,951 shares of
common stock issuable upon the exercise of warrants issued to the
placement agent, each as described in this prospectus supplement), as if
this offering had occurred on August 31,
2009.
|
This table should be read in
conjunction with “Use of Proceeds” and our consolidated financial statements and
the accompanying notes, which are incorporated by reference into this prospectus
supplement.
|
|
|
|
|
|
|
|
|
|
|
As
of August 31, 2009
|
|
|
|
Actual
|
|
|
As Adjusted
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities
|
|
$
|
3,701,787
|
|
|
$
|
10,601,787
|
|
Long-term
debt
|
|
$
|
6,676
|
|
|
$
|
6,676
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value, 150,000,000 shares authorized,
17,857,555 issued and outstanding, actual; 21,605,113 issued and
outstanding, as adjusted
|
|
$
|
17,858
|
|
|
$
|
21,605
|
|
Preferred
stock, $0.001 par value, 15,000,000 shares authorized, none
issued and outstanding, actual and as adjusted
|
|
|
—
|
|
|
|
—
|
|
Additional
paid-in capital
|
|
|
27,364,286
|
|
|
|
34,260,539
|
|
Accumulated
deficit
|
|
|
(21,879,183
|
)
|
|
|
(21,879,183
|
)
|
|
|
|
|
|
|
|
|
|
Total
stockholders’ equity
|
|
$
|
5,502,961
|
|
|
$
|
12,402,961
|
|
|
|
|
|
|
|
|
|
|
The
number of shares of our common stock to be in the actual and as adjusted columns
in the table above excludes the following shares of our common stock as of
August 31, 2009:
|
·
989,213 shares of our common stock issuable upon the exercise of options
outstanding under our stock option plans at a weighted average exercise
price of $2.42 per share;
|
|
·
406,147 shares of our common stock available for future issuance
under our stock option plans; and
|
|
·
2,057,990 shares of our common stock issuable upon exercise of
outstanding warrants at a weighted average exercise price of $2.67 per
share.
|
S-31
PLAN OF
DISTRIBUTION
Pursuant to General Instruction I.B.6.
of Form S-3, we are permitted to utilize the registration statement of which
this prospectus supplement forms a part to sell a maximum amount of securities
equal to one-third of the aggregate market value of the outstanding voting and
non-voting common equity held by our non-affiliates in any 12-month period. We
may, from time to time, offer the securities registered hereby up to this
maximum amount.
We have entered into a placement agent
agreement with Ladenburg Thalmann & Co. Inc., or Ladenburg, with respect to
the units being offered hereby. The material terms and provisions of
the placement agent agreement are summarized below. This summary is subject to
and qualified in its entirety by the placement agent agreement, which will be
filed with the SEC on a Current Report on Form 8-K in connection with this
offering and which will be incorporated by reference into the registration
statement of which this prospectus supplement forms a part.
Subject to the terms and conditions
stated in our placement agent agreement with Ladenburg, Ladenburg has agreed to
act, on a best efforts basis, as our placement agent in connection with the sale
by us of up to 3,747,558 units in this offering in a proposed takedown from
our shelf registration statement. Ladenburg is acting as the sole
placement agent for this offering. The placement agent is not purchasing
or selling any units pursuant to the placement agent agreement, this prospectus
supplement or accompanying prospectus, nor are we requiring that the placement
agent arrange for the purchase or sale of any minimum or specific number or
dollar amount of units. The placement agent will have no authority to
bind us by virtue of the placement agent agreement. Further, the placement agent
does not guarantee that it will be able to raise new capital in any prospective
offering. We will enter into a securities purchase agreement directly
with investors in connection with this offering and we will only sell to
investors who have entered into the securities purchase
agreement. The material terms and provisions of the securities
purchase agreement are summarized below. This summary is subject to and
qualified in its entirety by the securities purchase agreement, which will be
filed with the SEC on a Current Report on Form 8-K in connection with this
offering and which will be incorporated by reference into the registration
statement of which this prospectus supplement forms a part.
Our obligation to issue and sell units
to investors is subject to certain conditions precedent as set forth in the
securities purchase agreement, which may be waived by us in our discretion. An
investor’s obligation to purchase units is subject to certain conditions
precedent as set forth in the securities purchase agreement, including the
absence of any material adverse change in our business and the receipt of
certain opinions, letters and certificates from our counsel, our independent
auditors and us.
Unless investors instruct us otherwise,
we will deliver the shares of common stock being issued to the investors
electronically upon receipt of investor funds for the purchase of the units
offered pursuant to this prospectus supplement, and we will issue the warrants
in registered physical form to investors. We expect to deliver the shares of our
common stock and the warrants being offered pursuant to this prospectus
supplement on or about December 22, 2009.
We have
agreed to pay the placement agent a total fee equal to 6.5% of the aggregate
cash proceeds of this offering (excluding any proceeds from exercise of the
warrants). Only in the event the offering closes, we have agreed to reimburse
the placement agent for its out-of-pocket accountable expenses actually incurred
by it in connection with this offering, in an amount not to exceed 0.5% of the
aggregate gross proceeds of this offering, but in no event more than
$30,000.
The
following table summarizes the placement agent fees that we will pay to the
placement agent in connection with this offering.
|
|
|
|
|
Per
Unit
|
|
$
|
0.13
|
|
|
|
|
|
|
Total
|
|
$
|
0.13
|
|
In addition, we agreed to issue
compensation warrants to the placement agent to purchase shares of our common
stock equal to 2.0% of the aggregate number of shares of common stock sold in
this offering (not including shares of common stock issuable upon the exercise
of Warrants issued in this offering), which will allow them to purchase an
aggregate of up to 74,951 shares of our common stock. The compensation warrants
will be substantially on the same terms as the warrants offered to investors
hereby, except that the compensation warrants will have an exercise price equal
to $2.50 (which is 125% of the public offering price per share), will expire on
November 5, 2014 (five years from the effective date of the registration
statement which this prospectus supplement forms a part) and will otherwise
comply with the rules of the FINRA.
We
estimate that the total fees and expenses payable by us to Ladenburg, excluding
discounts and commissions, will be approximately $30,000, which includes up to
$30,000 that we agreed to reimburse Ladenburg for the fees, disbursements and
other expenses incurred by it. Because there is no minimum offering
amount required as a condition to closing of this offering, the actual total
offering commissions, if any, may be substantially less than the total offering
amounts set forth above.
S-32
The
placement agent may engage other FINRA member firms to act as selected dealers
in connection with the offering. In compliance with the guidelines of
the FINRA, the maximum consideration or discount to be received by the placement
agent, as a member of FINRA, other FINRA member firms engaged by the placement
agent or any independent broker dealer, will not exceed 8.0% of the gross
proceeds to us from the sale of any securities offered pursuant to this
prospectus supplement and the accompanying prospectus. Based upon
information available to the Company, an employee of the placement agent
beneficially owns (through an affiliate, Flower Ventures LLC) approximately 4%
of our outstanding common stock (which excludes warrants beneficially owned by
such employee to purchase our common stock that are not exercisable within sixty
(60) days of the date of this prospectus supplement).
The placement agent has informed us
that it will not engage in over-allotment, stabilizing or syndicate covering
transactions in connection with this offering. The placement agent
agreement provides that the obligations of the placement agent are subject to
certain conditions precedent, including the absence of any material adverse
change in our business and the receipt of certain certificates, opinions and
letters from us, our counsel and our auditors.
We have agreed to indemnify the
placement agent and specified other persons against some civil liabilities,
including liabilities under the Securities Act or the Exchange Act, and to
contribute to payments that the placement agent may be required to make in
respect of those liabilities.
Our executive officers and directors
have agreed with the placement agent, subject to certain exceptions, not to
dispose of or hedge any shares of common stock or securities convertible into or
exchangeable for shares of common stock, subject to specified exceptions, during
the period from the date of this prospectus supplement continuing through the
date 90 days after the date of this prospectus supplement, except with the prior
written consent of the placement agent.
The 90-day restricted period described
in the preceding paragraph will be automatically extended if: (i) during the
period that begins on the date that is 15 calendar days plus three business days
before the last day of the 90-day restricted period and ends on the last day of
the 90-day restricted period, we issue an earnings release or material news or a
material event relating to the company occurs, or (ii) prior to the expiration
of the 90-day restricted period, we announce that we will release earnings
results during the 16-day period beginning on the last day of the 90-day
restricted period, the restrictions will continue to apply until the expiration
of the date that is 15 calendar days plus three business days after the date on
which the issuance of the earnings release or the material news or material
event occurs; provided, however, this provision will not apply if, within three
days of the termination of the 90-day restricted period, we deliver to the
placement agent a certificate, signed by our chief financial officer or chief
executive officer, certifying that our shares of common stock are, as of the
date of delivery of such certificate, “actively trading securities,” as defined
in Regulation M under the Exchange Act.
S-33
DESCRIPTION
OF SECURITIES WE ARE OFFERING
In this offering we are offering
3,747,558 units for an aggregate of shares of our common stock and Warrants
to purchase up to in the aggregate 3,747,558 shares of our common stock,
subject to adjustment as provided in the Warrants. Units will not be issued or
certificated. The shares of common stock and the Warrants will be issued
separately.
Common Stock
The material terms and provisions of
our common stock and each other class of our securities which qualifies or
limits our common stock are described under the caption “Description of Our
Capital Stock” starting on page 6 of the accompanying prospectus.
Warrants
The material terms and provisions of
our warrants that we are offering in this offering are described under the
caption “Description of Warrants” immediately below.
DESCRIPTION OF
WARRANTS
The material terms and provisions of
the Series A Warrants and the Series B Warrants being offered pursuant to this
prospectus supplement and the accompanying prospectus are summarized below. This
summary is subject to and qualified in its entirety by the form of warrant,
which will be provided to each investor in this offering and will be filed on a
Current Report on Form 8-K in connection with this offering.
The Series A Warrants to be issued in
this offering to each investor represent the right to purchase up to in the
aggregate 50% of the shares of common stock purchased by such investor at an
initial exercise price of $2.45 per share, subject to anti-dilution adjustments
described below. The Series B Warrants to be issued in this offering
to each investor represent the right to purchase up to in the aggregate 50% of
the shares of common stock purchased by such investor at an initial exercise
price of $2.45 per share, subject to anti-dilution adjustments described
below. Each warrant may be exercised at any time and from time to
time on or after one hundred eighty (180) days from its original date of
issuance (such original date of issuance anticipated to be on or about
December 22, 2009) and, in the case of the Series A Warrants, through and
including the fifth (5th) anniversary of the original date of issuance, and, in
the case of the Series B Warrants, through and including the eighteen month (18)
anniversary of the original date of issuance. Except in certain circumstances
noted below, the exercise price must be paid in cash at the time of
exercise.
Exercise
Holders of the warrants may exercise
their warrants to purchase shares of our common stock on or before the
termination date by delivering (i) a notice of exercise, appropriately
completed and duly signed, and (ii) payment of the exercise price for the
number of shares with respect to which the warrant is being exercised, by wire
transfer of immediately available funds to us, except if such holder is
permitted to and in fact utilizes the cashless exercise provisions with respect
to the warrants. Warrants may be exercised in whole or in part, but only for
full shares of common stock. Any portion of a warrant not exercised prior to the
termination date shall automatically become void and of no value and shall be
terminated on the termination date. We provide certain buy-in rights to a holder
if we fail to deliver the shares of common stock underlying the warrants by the
third trading day after the date on which delivery of the stock certificate is
required by the warrant. The buy-in rights apply if after the third trading day
on which delivery of the stock certificate is required by the warrant, the
holder is required by its broker to purchase shares of our common stock to
deliver in satisfaction of a sale by the holder of the warrant shares that the
holder anticipated receiving from us upon exercise of the warrant. In this
event, we will:
•
|
|
pay
in cash to the holder the amount by which (x) the holder’s total purchase
price (including brokerage commissions, if any) for the shares of common
stock so purchased exceeds (y) the amount obtained by multiplying (A) the
number of warrant shares that the Company was required to deliver to the
holder in connection with the exercise at issue times (B) the price at
which the sell order giving rise to such purchase obligations was
executed; and
|
|
|
|
•
|
|
at
the option of the Holder, either reinstate the portion of the warrant and
equivalent number of warrant shares for which such exercise was not
honored or deliver to the holder the number of shares of common stock that
would have been issued had the Company timely complied with its exercise
and delivery obligations.
|
S-34
In
addition, the warrant holders are entitled to a “cashless exercise” option if,
at time of exercise, there is no effective registration statement registering,
or no current prospectus available for, the issuance of the shares of common
stock underlying the warrants. This option entitles the warrant holders to elect
to receive fewer shares of common stock without paying the cash exercise price.
The number of shares to be issued would be determined by a formula based on the
total number of shares with respect to which the warrant is being exercised, the
volume weighted average of the price per share of our common stock for the
trading day immediately prior to the date of exercise and the applicable
exercise price of the warrants. The shares of common stock issuable
on exercise of the warrants will be, when issued and paid for in accordance with
the warrants, duly and validly authorized, issued and fully paid and
non-assessable. We have agreed to reserve that number of shares of common stock
equal to the number of shares of common stock issuable upon exercise of all
warrants issued pursuant to this offering.
Fundamental
Transaction
If, at any time while the warrants are
outstanding, we (1) directly or indirectly, in one or more related transactions,
consolidate or merge with or into another person, (2) sell, lease, license,
assign, transfer, convey or otherwise dispose of all or substantially all of our
assets or (3) are subject to or complete any direct or indirect, purchase offer,
tender offer or exchange offer pursuant to which holders of our common stock are
permitted to sell, tender or exchange their shares for other securities, cash or
property and has been accepted by the holders of 50% or more of the outstanding
common stock, (4) directly or indirectly, in one or more related transactions,
effect any reclassification, reorganization or recapitalization of our common
stock or any compulsory share exchange pursuant to which our common stock is
effectively converted into or exchanged for other securities, cash or property,
or (5) directly or indirectly engage in one or more related transactions that
consummates a stock or share purchase agreement or other business
combination (including, without limitation, a reorganization, recapitalization,
spin-off or scheme of arrangement) with another person whereby such other person
acquires more than 50% of the outstanding shares of common stock (not including
any shares of common stock held by the other person or other persons making or
party to, or associated or affiliated with the other Persons making or party to,
such stock or share purchase agreement or other business combination), then the
holder shall have the right thereafter to receive, upon exercise of the warrant,
the same amount and kind of securities, cash or property as it would have been
entitled to receive upon the occurrence of such Fundamental Transaction if it
had been, immediately prior to such Fundamental Transaction, the holder of the
number of warrant shares then issuable upon exercise of the warrant, and any
additional consideration payable as part of the Fundamental Transaction. Any
successor to us or surviving entity shall assume the obligations under the
warrant.
In the event of certain Fundamental
Transactions, the holders of the warrants will be entitled to receive, in lieu
of our common stock and at the holders’ option, cash in an amount equal to the
value of the remaining unexercised portion of the warrant on the date of the
transaction determined using Black-Scholes option pricing model obtained from
the "OV" function on Bloomberg, L.P. with an expected volatility equal to the
greater of 100% and the 100 day volatility obtained from the HVT by Bloomberg
L.P. as of the trading day immediately following the public announcement of the
transaction.
Subsequent
Rights Offerings
If, at any time while the warrants are
outstanding, we issue rights, options or warrants to all holders of our common
stock entitling them to purchase our common stock at a price per share less than
the volume weighted average price on the record date for such issuance of such
rights, options or warrants, then the exercise price will adjust pursuant to a
volume weighted average price based ratio.
Pro
Rata Distributions
If, at any time while the warrants are
outstanding, we distribute evidences of our indebtedness, assets, or rights or
warrants to purchase any security for no consideration to all holders of our
common stock, then the exercise price will adjust pursuant to a volume weighted
average price based ratio.
Certain Other
Adjustments
The exercise price and the number of
shares of common stock purchasable upon the exercise of the warrants are subject
to adjustment upon the occurrence of specific events, including stock dividends,
stock splits and combinations of our common stock.
S-35
Delivery of
Certificates
Upon the holder’s exercise of a warrant
in accordance with its terms, we will promptly, but in no event later than three
trading days after the exercise date, or the Warrant Share Delivery Date, issue
and deliver, or cause to be issued and delivered, a certificate for the shares
of common stock issuable upon exercise of the warrant. If the warrant shares can
be issued without restrictive legends and if the holder provides the necessary
information to us, we will use commercially reasonable efforts to deliver the
shares electronically through The Depository Trust and Clearing
Corporation or another established clearing corporation performing similar
functions. If we fail to deliver certificates evidencing the warrant shares by
the Warrant Share Delivery Date, we may be required to comply with the buy-in
provisions as described above under the heading, “Exercise.”
Notice of Corporate
Action
We will provide notice to holders of
the warrants to provide them with the opportunity to exercise their warrants and
hold common stock in order to participate in or vote on the following corporate
events:
•
|
|
declarations
of any dividend or any other distribution of cash, securities or other
property in respect of our common stock, including without limitation any
granting of rights or warrants to subscribe for or purchase any of our
capital stock;
|
|
|
|
•
|
|
solicitation
of stockholder approval for any Fundamental Transaction;
or
|
|
|
|
•
|
|
a
voluntary dissolution, liquidation or winding up of our
company.
|
Limitations on
Exercise
The number of warrant shares that may
be acquired by any holder upon any exercise of the warrant shall be limited to
the extent necessary to insure that, following such exercise (or other
issuance), the total number of shares of common stock then beneficially owned by
such holder and its affiliates and any other persons whose beneficial ownership
of common stock would be aggregated with the holder’s for purposes of Section
13(d) of the Exchange Act, as amended, does not exceed 4.99% of the total number
of issued and outstanding shares of our common stock (including for such purpose
the shares of common stock issuable upon such exercise), or beneficial ownership
limitation. The holder may elect to change this beneficial ownership limitation
from 4.99% to 9.9% of the total number of issued and outstanding shares of our
common stock (including for such purpose the shares of common stock issuable
upon such exercise) upon 61 days’ prior written notice to us.
Additional
Provisions
The above summary of certain terms and
provisions of the warrants is qualified in its entirety by reference to the
detailed provisions of the warrants, the form of which will be filed as an
exhibit to a current report on Form 8-K that is incorporated herein by
reference. We are not required to issue fractional shares upon the exercise of
the warrants. No holders of the warrants will possess any rights as a
stockholder under those warrants until the holder exercises those warrants. The
warrants may be transferred independent of the common stock they were issued
with, on a form of assignment, subject to all applicable laws.
S-36
Paul,
Hastings, Janofsky & Walker LLP, Los Angeles, California will pass upon the
validity of the securities being offered by this prospectus supplement. Any
placement agent, dealer or agent may be advised about issues relating to any
offering by its own legal counsel.
EXPERTS
Burr,
Pilger & Mayer, LLP, independent registered public accounting firm, has
audited the consolidated financial statements of Raptor Pharmaceuticals Corp.
included in Raptor Pharmaceuticals Corp.’s Annual Report on Form 10-K, for the
year ended August 31, 2009 as set forth in its report (which contains an
explanatory paragraph describing conditions that raise substantial doubt about
Raptor Pharmaceuticals Corp.’s ability to continue as a going concern as
described in Note 1 to such consolidated financial statements) which is
incorporated by reference in this prospectus supplement and elsewhere in the
registration statement of Raptor Pharmaceutical Corp. of which this prospectus
supplement forms a part. Such consolidated financial statements of
Raptor Pharmaceuticals Corp. are incorporated by reference in reliance on Burr,
Pilger & Mayer, LLP’s reports, given on the authority of such firm as
experts in accounting and auditing. Burr, Pilger & Mayer, LLP are the
auditors for our fiscal year ended August 31, 2009.
Ernst
& Young LLP, independent registered public accounting firm, has audited the
consolidated financial statements of TorreyPines Therapeutics, Inc. (now known
as Raptor Pharmaceutical Corp.) included in TorreyPines Therapeutics, Inc.’s
Annual Report on Form 10-K, for the year ended December 31, 2008 as set forth in
its report (which contains an explanatory paragraph describing conditions that
raise substantial doubt about TorreyPines Therapeutics, Inc.’s ability to
continue as a going concern as described in Note 1 to such consolidated
financial statements), which is incorporated by reference in this prospectus
supplement and elsewhere in the registration statement of Raptor Pharmaceutical
Corp. of which this prospectus supplement forms a part. Such
consolidated financial statements of TorreyPines Therapeutics, Inc. are
incorporated by reference in reliance on Ernst & Young LLP’s reports, given
on the authority of such firm as experts in accounting and
auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We file
annual, quarterly and current reports, proxy statements and other information
with the SEC. You may read and copy any reports, statements or other information
that we file at the SEC’s Public Reference Room at 100 F Street, N.E.,
Washington, D.C. 20549 on official business days during the hours of 10AM to
3PM. 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 from commercial
document retrieval services and on the website maintained by the SEC at
http://www.sec.gov. Reports, proxy statements and other information concerning
us also may be inspected at the offices of the Financial Industry Regulatory
Authority, Inc., Listing Section, 1735 K Street, Washington, D.C. 20006.
You may also obtain free copies of the documents that we file with the SEC by
going to the Investors and Media section of our website, www.raptorpharma.com.
The information provided on our website is not part of this prospectus
supplement or in the accompanying prospectus and therefore is not incorporated
by reference.
We have
filed with the SEC a registration statement on Form S-3 relating to the
securities covered by this prospectus supplement. This prospectus supplement is
a part of the registration statement and does not contain all the information in
the registration statement. Whenever a reference is made in this prospectus
supplement to a contract or other document, the reference is only a summary and
you should refer to the exhibits that are a part of the registration statement
(including information incorporated by reference therein) for a copy of the
contract or other document. You may review a copy of the registration statement
at the SEC’s Public Reference Room in Washington, D.C., as well as through the
SEC’s internet website.
S-37
The SEC
allows us to “incorporate by reference” the information we file with it, which
means that we can disclose important information to you by referring you to
another document that we have filed separately with the SEC. You should read the
information incorporated by reference because it is an important part of this
prospectus supplement. Any information
incorporated by reference into this prospectus supplement is considered
to be part of this prospectus supplement from the
date we file that document. We incorporate by reference the following
information or documents that have been filed with the SEC which shall not
include, in each case, documents, or information deemed to have been furnished
and not filed in accordance with SEC rules:
• The
Consolidated Financial Statements set forth under Part II, Item 8 (Financial
Statements and Supplementary Data) and Part IV, Item 15 (Exhibits, Financial
Statement Schedules), as filed on October 28, 2009 by our wholly-owned
subsidiary, Raptor Pharmaceuticals Corp. (Commission File No. 000-50720) with
the SEC in its Annual Report of Form 10-K for the fiscal year ended August 31,
2009, which such consolidated financial statements include the (i) Report of
Independent Registered Public Accounting Firm, (ii) Consolidated Balance Sheets
as of August 31, 2009 and 2008, (iii) Consolidated Statements of Operations for
the years ended August 31, 2009 and 2008 and for the cumulative period from
September 8, 2005 (Raptor Pharmaceuticals Corp.’s inception) to August 31, 2009,
(iv) Consolidated Statements of Stockholders’ Equity for period from September
8, 2005 (Raptor Pharmaceuticals Corp.’s inception) to August 31, 2006 and the
years ended August 31, 2007, 2008 and 2009, (v) Consolidated Statements of Cash
Flows for the years ended August 31, 2009 and 2008 and for the cumulative period
from September 8, 2005 (Raptor Pharmaceuticals Corp.’s inception) to August 31,
2009, and (vi) Notes to Consolidated Financial Statements. Given that
Raptor Pharmaceuticals Corp. was the “accounting acquirer” in the reverse
merger, business combination that we completed with it in September 2009,
described under in the accompanying prospectus under the heading “Raptor
Pharmaceutical Corp.,” Raptor Pharmaceuticals Corp.’s financial statements
became the historical financial statements of the combined entity after such
transaction;
• Our
Annual Report on Form 10-K for the year ended December 31, 2008 filed with the
SEC on March 27, 2009—note that for accounting purposes we were “acquired” by
Raptor Pharmaceuticals Corp. pursuant to a reverse merger, business combination
on September 29, 2009;
• Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 filed with
the SEC on May 1, 2009—note that for accounting purposes we were “acquired” by
Raptor Pharmaceuticals Corp. pursuant to a reverse merger, business combination
on September 29, 2009;
• Our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2009 filed with the
SEC on August 11, 2009—note that for accounting purposes we were “acquired” by
Raptor Pharmaceuticals Corp. pursuant to a reverse merger, business combination
on September 29, 2009;
• Our
Current Reports on Form 8-K/A filed with the SEC on November 3, 2009, October 9,
2009 and October 7, 2009, our Current Reports on Form 8-K filed with the SEC on
December 15, 2009, November 17, 2009, October 5, 2009, and our Current Reports
on Form 8-K filed with the SEC, as filed by TorreyPines Therapeutics, Inc., on
July 31, 2009, July 28, 2009, July 22, 2009, June 17, 2009, May 29, 2009, May 1,
2009, April 24, 2009, April 2, 2009, March 31, 2009, March 27, 2009 and February
9, 2009;
• the
description of our common stock, which is registered under Section 12(b) of the
Exchange Act, in our registration statement on Form 10-SB filed with the SEC on
March 17, 1999, as amended by that registration statement on Form 10-SB/A filed
with the SEC on August 19, 1999, which description has been updated by our
Registration Statement on Form S-4 filed with the SEC on August 19, 2009 (See
section titled, “Description of TorreyPines’ Capital Stock”), and any amendment
or report filed with the SEC for the purpose of updating such description;
and
• the
description of our preferred share purchase rights, which are registered under
Section 12 of the Exchange Act, in our registration statement on Form 8-A filed
with the SEC on May 16, 2005, which description has been updated by our
Registration Statement on Form S-4 filed with the SEC on August 19, 2009 (See
section titled, “Description of TorreyPines’ Capital Stock”), and any amendment
or report filed with the SEC for the purpose of updating such
description.
Any
information in any of the foregoing documents will automatically be deemed to be
modified or superseded to the extent that information in this prospectus
supplement or in a later filed document or other report that is incorporated or
deemed to be incorporated herein by reference modifies or replaces such
information.
S-38
We also
incorporate by reference any future filings (other than current reports
furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such
form that are related to such items) made with the SEC pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act, until we file a post-effective
amendment that indicates the termination of the offering of the securities made
by this prospectus supplement. Information in such future filings updates and
supplements the information provided in this prospectus supplement. These
documents include proxy statements and periodic reports, such as Annual Reports
on Form 10-K, Quarterly Reports on Form 10-Q, and, to the extent they are
considered filed and, except as described above, Current Reports on Form 8-K.
Any statements in any such future filings will automatically be deemed to modify
and supersede any information in any document we previously filed with the SEC
that is incorporated or deemed to be incorporated herein by reference to the
extent that statements in the later filed document modify or replace such
earlier statements.
We will
provide to each person, including any beneficial owner, to whom a prospectus
supplement is delivered, without charge upon written or oral request, a copy of
any or all of the documents that are incorporated by reference into this
prospectus supplement but not delivered with the prospectus supplement,
including exhibits which are specifically incorporated by reference into such
documents. If you would like to request documents from us, please send a request
in writing or by telephone to us at the following address:
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Raptor
Pharmaceutical Corp.
9
Commercial Blvd., Suite 200
Novato,
CA 94949
(415)
382-1390
Attn:
Secretary
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Information
on Our Website
Information
on our website, any subsection, page, or other subdivision of our website, or
any website linked to by content on our website, is not part of this prospectus
supplement and you should not rely on that information unless that information
is also in this prospectus supplement or incorporated by reference in this
prospectus supplement.
Trademark
Notice
Raptor,
our logos and all of our product candidates and trade names are our registered
trademarks or our trademarks in the United States and in other select countries.
Other third-party logos and product/trade names are registered trademarks or
trade names of their respective companies.
S-39
Raptor Pharmaceutical
Corp.
3,747,558
Units
Consisting
of Common Stock and Warrants
Prospectus
Supplement
December
17, 2009
Ladenburg
Thalmann & Co. Inc.
PROSPECTUS
Raptor
Pharmaceutical Corp.
$30,000,000
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Units
From
time to time, Raptor Pharmaceutical Corp., or Raptor, may offer, issue and sell
up to $30,000,000 of any combination of the securities described in this
prospectus, either individually or in units. Raptor may also offer common stock
or preferred stock upon conversion of debt securities, common stock upon
conversion of preferred stock, or common stock, preferred stock or debt
securities upon the exercise of warrants.
Raptor
will provide the specific terms of these offerings and securities in one or more
supplements to this prospectus. Raptor may also authorize one or more free
writing prospectuses to be provided to you in connection with these offerings.
The prospectus supplement and any related free writing prospectus may also add,
update or change information contained in this prospectus. You should carefully
read this prospectus, the applicable prospectus supplement and any related free
writing prospectus, as well as any documents incorporated by reference, before
buying any of the securities being offered.
Raptor’s
common stock is traded on the NASDAQ Capital Market under the symbol “RPTPD.” On
October 6, 2009, the last reported sale price of its common stock on the NASDAQ
Capital Market was $3.25. The applicable prospectus supplement will contain
information, where applicable, as to any other listing, if any, on the NASDAQ
Capital Market or any securities market or other exchange of the securities
covered by the applicable prospectus supplement. The aggregate market value of
our outstanding common equity held by non-affiliates on October 6, 2009 was
approximately $55.5 million. We have not issued any securities pursuant to
Instruction I.B.6 of Form S-3 during the 12 calendar month period that ends on
and includes the date hereof.
Investing in Raptor’s
securities involves a high degree of risk. You should review carefully the risks
and uncertainties described under the heading “Risk Factors” on page 2 and
contained in the applicable prospectus supplement and any related free writing
prospectus, and under similar headings in the other documents that are
incorporated by reference into this prospectus.
This prospectus may not be used
to consummate a sale of any securities unless accompanied by a prospectus
supplement.
The
securities may be sold directly by Raptor to investors, through agents
designated from time to time or to or through underwriters or dealers, on a
continuous or delayed basis. For additional information on the methods of sale,
you should refer to the section titled “Plan of Distribution” in this
prospectus. If any agents or underwriters are involved in the sale of any
securities with respect to which this prospectus is being delivered, the names
of such agents or underwriters and any applicable fees, commissions, discounts
and over-allotment options will be set forth in a prospectus supplement. The
price to the public of such securities and the net proceeds that Raptor expects
to receive from such sale will also be set forth in a prospectus
supplement.
Neither the Securities and
Exchange Commission nor any state securities commission has approved or
disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus is November 5, 2009.
TABLE
OF CONTENTS
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Page
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ABOUT
THIS PROSPECTUS
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1
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RAPTOR
PHARMACEUTICAL CORP.
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2
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RISK
FACTORS
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2
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FORWARD-LOOKING
STATEMENTS
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3
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THE
SECURITIES WE MAY OFFER
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4
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USE
OF PROCEEDS
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6
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DESCRIPTION
OF OUR CAPITAL STOCK
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6
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DESCRIPTION
OF DEBT SECURITIES
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11
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DESCRIPTION
OF WARRANTS
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14
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DESCRIPTION
OF UNITS
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15
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LEGAL
OWNERSHIP OF SECURITIES
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16
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PLAN
OF DISTRIBUTION
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19
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LEGAL
MATTERS
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21
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EXPERTS
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21
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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21
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ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed
with the Securities and Exchange Commission, or SEC, utilizing a “shelf”
registration process. Under this shelf registration process, we may offer shares
of our common stock or preferred stock, various series of debt securities and/or
warrants to purchase any of such securities, either individually or in units, in
one or more offerings, up to a total dollar amount of $30,000,000. This
prospectus provides you with a general description of the securities we may
offer. Each time we offer a type or series of securities under this prospectus,
we will provide a prospectus supplement that will contain more specific
information about the terms of those securities. We may also authorize one or
more free writing prospectuses to be provided to you that may contain material
information relating to these offerings. We may also add or update in the
prospectus supplement (and in any related free writing prospectus that we may
authorize to be provided to you) any of the information contained in this
prospectus or in the documents we have incorporated by reference into this
prospectus. We urge you to carefully read this prospectus, any applicable
prospectus supplement and any related free writing prospectus, together with the
information incorporated herein by reference as described under the heading
“Where You Can Find Additional Information,” before buying any of the securities
being offered. THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF
SECURITIES UNLESS IT IS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
You
should rely only on the information that we have provided or incorporated by
reference in this prospectus, any applicable prospectus supplement and any
related free writing prospectus that we may authorize to be provided to you. We
have not authorized anyone to provide you with different information. No dealer,
salesperson or other person is authorized to give any information or to
represent anything not contained in this prospectus, any applicable prospectus
supplement or any related free writing prospectus that we may authorize to be
provided to you. You must not rely on any unauthorized information or
representation. If
anyone provides you with different or inconsistent information, you should not
rely on it. This prospectus is an offer to sell only the securities
offered hereby, but only under circumstances and in jurisdictions where it is
lawful to do so. We
will not make an offer to sell our securities in any jurisdiction where the
offer or sale is not permitted. You should assume that the information in
this prospectus, any applicable prospectus supplement, any related free writing
prospectus, is accurate only as of the date on the front cover of this
prospectus and that any information we have incorporated by reference is
accurate only as of the date of the document incorporated by reference,
regardless of the time of delivery of this prospectus, any applicable prospectus
supplement or any related free writing prospectus, or any sale of a security.
Our business,
financial condition, results of operations and prospects may have changed since
that date.
This
prospectus contains summaries of certain provisions contained in some of the
documents described herein, but reference is made to the actual documents for
complete information. All of the summaries are qualified in their entirety by
the actual documents. The registration statement containing this prospectus,
including exhibits to the registration statement, provides additional
information about us and the securities offered under this prospectus. Copies of
some of the documents referred to herein have been filed, will be filed or will
be incorporated by reference as exhibits to the registration statement of which
this prospectus is a part, and you may obtain copies of those documents as
described below under the heading “Where You Can Find Additional
Information.”
RAPTOR
PHARMACEUTICAL CORP.
Raptor
Pharmaceutical Corp., or Raptor, was initially incorporated in Nevada on
July 29, 1997 as Axonyx Inc. In October 2006, Axonyx Inc. and its
then-wholly-owned subsidiary completed a reverse merger, business combination
with TorreyPines Therapeutics, Inc., reincorporated in Delaware and changed
its name to TorreyPines Therapeutics, Inc. In September 2009, we and our
wholly-owned subsidiary completed a reverse merger, business combination with
Raptor Pharmaceuticals Corp. pursuant to which Raptor Pharmaceuticals Corp.
became our wholly-owned subsidiary. Immediately prior to the merger, we changed
our corporate name from TorreyPines Therapeutics, Inc. to Raptor Pharmaceutical
Corp. Raptor’s principal executive offices are located at 9 Commercial Blvd.,
Suite 200, Novato, CA 94949, and Raptor’s telephone number is (415) 382-8111.
Raptor is a NASDAQ-listed development-stage biotechnology company dedicated to
speeding the delivery of new treatment options to patients by working to improve
existing therapeutics through the application of highly specialized drug
targeting platforms and formulation expertise. Raptor focuses on underserved
patient populations where it believes that it can have the greatest potential
impact. Raptor is developing drug therapies for the potential treatment of:
genetic diseases including nephropathic cystinosis, or cystinosis, and
Huntington’s Disease, or HD; metabolic diseases including non-alcoholic
steatohepatitis, or NASH, and aldehyde dehydrogenase, or ALDH2, deficiency, or
Ethanol Intolerance; and liver diseases including primary liver cancer or
hepatocellular carcinoma, or HCC, and hepatitis. Raptor is also researching a
non-opioid solution designed to treat chronic pain and potentially thrombotic
disorder.
We
obtained statistical data, market data and other industry data and forecasts
used throughout, or incorporated by reference in, this prospectus from market
research, publicly available information and industry publications. Industry
publications generally state that they obtain their information from sources
that they believe to be reliable, but they do not guarantee the accuracy and
completeness of the information. Similarly, while we believe that the
statistical data, industry data and forecasts and market research are reliable,
we have not independently verified the data, and we do not make any
representation as to the accuracy of the information. We have not sought the
consent of the sources to refer to their reports appearing or incorporated by
reference in this prospectus.
As
described elsewhere in this prospectus under the heading “Where You Can Find
More Information.,” this prospectus and the information incorporated herein by
reference include trademarks, service marks and trade names owned by us or other
companies. All trademarks, service marks and trade names included or
incorporated by reference into this prospectus, any applicable prospectus
supplement or any related free writing prospectus are the property of their
respective owners.
In this prospectus, we
refer to common stock, preferred stock, debt securities, warrants and units
collectively as “securities.” Unless otherwise mentioned
or unless the context requires otherwise, all references in this prospectus to
“we,” “us,” “our,” the “Company,” “Raptor” and similar references refer to
Raptor Pharmaceutical Corp., a Delaware corporation, and its wholly-owned
subsidiaries; except
that in the description of the securities we may offer these terms refer solely
to Raptor Pharmaceutical Corp. and not to any of our
subsidiaries.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. You should carefully review
the risks and uncertainties described under the heading “Risk Factors” contained
in the applicable prospectus supplement and any related free writing prospectus,
and under similar headings in the other documents, including our most recent
annual report on Form 10-K, any subsequent quarterly reports on Form 10-Q or
current report on Form 8-K we file after the date of this prospectus, that are
incorporated by reference into this prospectus. The occurrence of any of these
risks might cause you to lose all or part of your investment in the offered
securities. Additional risks not presently known to us or that we currently
believe are immaterial may also significantly impair our business operations and
financial condition.
FORWARD-LOOKING
STATEMENTS
This
prospectus and the documents incorporated by reference contain “forward-looking
statements” of Raptor within the meaning of Section 27A of the Securities Act of
1933, as amended (the “Securities Act”) and Section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). These statements involve
known and unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be materially different
from any future results, performances or achievements expressed or implied by
the forward-looking statements. Forward-looking statements may include
statements relating to:
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projections
of our results of operations and financial condition and
businesses;
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anticipated
development, regulatory submissions, regulatory approval and
commercialization of our drug
candidates;
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the
efficacy, safety and intended utilization of our drug
candidates;
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competition
and consolidation in the markets in which we
compete;
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existing
and future collaborations and
partnerships;
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our
ability to comply with government
regulations;
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our
ability to expand and protect our intellectual property
portfolio;
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anticipated
future losses;
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the
conduct and results of our research, discovery and preclinical efforts and
clinical trials; and
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our
plans regarding future research, discovery and preclinical efforts and
clinical activities and collaborative, intellectual property and
regulatory activities.
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Words such as
“anticipates,” “believes,” “forecast,” “potential,” “contemplates,” “expects,”
“intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” “will,”
“may,” “can” and similar expressions identify forward-looking statements. These
forward-looking statements are not guarantees of future performance and are
subject to risks and uncertainties that could cause actual results to differ
materially from the results contemplated by the forward-looking statements. Many
of the important factors that will determine these results and values are beyond
our ability to control or predict. You are cautioned not to put undue reliance
on any forward-looking statements. Except as otherwise required by law, we do
not assume any obligation to update any forward-looking statements. In
evaluating an investment in our securities, you should carefully consider the
discussion of risks and uncertainties described under the heading “Risk Factors”
contained in this prospectus and the applicable prospectus supplement and any
related free writing prospectus, and under similar headings in the other
documents, including our most recent annual report on Form 10-K and in our most
recent quarterly report on Form 10-Q, as well as any amendments thereto
reflected in subsequent filings with the SEC. You should carefully read both
this prospectus, the applicable prospectus supplement and any related free
writing prospectus, together with the information incorporated herein by
reference as described under the heading “Where You Can Find Additional
Information,” completely and with the understanding that our actual future
results may be materially different from what we expect.
THE
SECURITIES WE MAY OFFER
We
may offer shares of our common stock or preferred stock, various series of debt
securities and/or warrants to purchase any of such securities, either
individually or in units, in one or more offerings, with a total value of up to
$30,000,000 from time to time under this prospectus at prices and on terms to be
determined by market conditions at the time of any offering. This prospectus
provides you with a general description of the securities we may offer. Each
time we offer a type or series of securities under this prospectus, we will
provide a prospectus supplement that will describe the specific amounts, prices
and other important terms of the securities including, to the extent
applicable:
• designation
or classification;
• aggregate
principal amount or aggregate offering price;
• maturity,
if applicable;
• original
issue discount, if any;
• rates
and times of payment of interest or dividends, if any;
• redemption,
conversion, exercise, exchange or sinking fund terms, if any;
• ranking;
• restrictive
covenants, if any;
• voting
or other rights, if any;
• conversion
prices, if any; and
• important
United States federal income tax considerations.
The
prospectus supplement and any related free writing prospectus that we may
authorize to be provided to you may also add or update information contained in
this prospectus or in documents we have incorporated by reference. However, no
prospectus supplement or free writing prospectus will offer a security that is
not registered and described in this prospectus at the time of the effectiveness
of the registration statement of which this prospectus is a part.
THIS
PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF SECURITIES UNLESS IT IS
ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
We may sell the securities directly to investors or to or through agents,
underwriters or dealers. We, and our agents or underwriters, reserve the right
to accept or reject all or part of any proposed purchase of securities. If we do
offer securities to or through agents or underwriters, we will include in the
applicable prospectus supplement:
• the
names of those agents or underwriters;
• applicable
fees, discounts and commissions to be paid to them;
• details
regarding over-allotment options, if any; and
• the
net proceeds to us.
Common
Stock. We may issue shares of our common stock from
time to time. The holders of common stock are entitled to one vote for each
share held of record on all matters submitted to a vote of stockholders and do
not have cumulative voting rights. Subject to preferences that may be applicable
to any outstanding shares of preferred stock, the holders of common stock are
entitled to receive ratably only those dividends as may be declared by our board
of directors out of legally available funds. Upon our liquidation, dissolution
or winding up, holders of our common stock are entitled to share
ratably in all assets remaining after payment of liabilities and the liquidation
preferences of any outstanding shares of preferred stock.
Preferred
Stock. We may issue shares of our preferred stock from
time to time, in one or more series. Under our certificate of incorporation, as
amended, our board of directors has the authority, without further action by
stockholders, to designate up to 15,000,000 shares of preferred stock in one or
more series and to fix the rights, preferences, privileges, qualifications and
restrictions granted to or imposed upon the preferred stock, including dividend
rights, conversion rights, voting rights, rights and terms of redemption,
liquidation preference and sinking fund terms, any or all of which may be
greater than the rights of the common stock.
If
we sell any series of preferred stock under this prospectus, we will fix the
designations, powers, preferences and rights of such series of preferred stock,
as well as the qualifications, limitations or restrictions thereon, in the
certificate of designation relating to that series. We will file as an exhibit
to the registration statement of which this prospectus is a part, or will
incorporate by reference from reports that we file with the SEC, the form of any
certificate of designation that describes the terms of the series of preferred
stock we are offering before the issuance of the related series of preferred
stock. We urge you to read the applicable prospectus supplement (and any free
writing prospectus that we may authorize to be provided to you) related to the
series of preferred stock being offered, as well as the complete certificate of
designation that contains the terms of the applicable series of preferred
stock.
Debt
Securities. We may issue debt securities from time to
time, in one or more series, as either senior or subordinated debt or as senior
or subordinated convertible debt. The senior debt securities will rank equally
with any other unsecured and unsubordinated debt. The subordinated debt
securities will be subordinate and junior in right of payment, to the extent and
in the manner described in the instrument governing the debt, to all of our
senior indebtedness. Convertible debt securities will be convertible into or
exchangeable for our common stock or our other securities. Conversion may be
mandatory or at your option and would be at prescribed conversion
rates.
The
debt securities will be issued under one or more indentures, which are contracts
between us and a national banking association or other eligible party, as
trustee. In this prospectus, we have summarized certain general features of the
debt securities. We urge you, however, to read the applicable prospectus
supplement (and any free writing prospectus that we may authorize to be provided
to you) related to the series of debt securities being offered, as well as the
complete indentures that contain the terms of the debt securities. Forms of indentures have
been filed as exhibits to the registration statement of which this prospectus is
a part, and supplemental indentures and forms of debt securities containing the
terms of the debt securities being offered will be filed as exhibits to the
registration statement of which this prospectus is a part or will be
incorporated by reference from reports that we file with the
SEC.
Warrants.
We may
issue warrants for the purchase of common stock, preferred stock and/or debt
securities in one or more series. We may issue warrants together with common
stock, preferred stock and/or debt securities, and the warrants may be attached
to or separate from these securities. In this prospectus, we have summarized
certain general features of the warrants. We urge you, however, to read the
applicable prospectus supplement (and any free writing prospectus that we may
authorize to be provided to you) related to the particular series of warrants
being offered, as well as the complete warrant agreements and warrant
certificates that contain the terms of the warrants. We will file as an exhibit
to the registration statement of which this prospectus is a part, or will
incorporate by reference from reports that we file with the SEC, forms of the
warrant agreements and forms of warrant certificates containing the terms of the
warrants being offered.
We
will evidence each series of warrants by warrant certificates that we will
issue. Warrants may be issued under an applicable warrant agreement that we
enter into with a warrant agent. We will indicate the name and address of the
warrant agent, if applicable, in the prospectus supplement relating to the
particular series of warrants being offered.
Units.
We may issue, in one or more series, units consisting
of common stock, preferred stock, debt securities and/or warrants for the
purchase of common stock, preferred stock and/or debt securities in any
combination. In this prospectus, we have summarized certain general features of
the units. We urge you, however, to read the applicable prospectus supplement
(and any free writing prospectus that we may authorize to be provided to you)
related to the series of units being offered, as well as the complete unit
agreement that contains the terms of the units. We will file as exhibits to the
registration statement of which this prospectus is a part, or will incorporate
by reference from reports that we file with the SEC, the form of unit agreement
and any supplemental agreements that describe the terms of the series of units
it is offering before the issuance of the related series of
units.
USE OF PROCEEDS
Except
as described in any prospectus supplement or in any related free writing
prospectus that we may authorize to be provided to you, we currently intend to
use the net proceeds from the sale of the securities offered hereby for general
corporate purposes, including, among other things, working capital to support
our clinical and preclinical stage drug candidate programs and potential
re-payment of indebtedness that may be outstanding at the time of any offering
under this prospectus. We have not specifically allocated the proceeds to those
purposes as of the date of this prospectus. We may also use a portion of the net
proceeds to acquire or invest in businesses, services and technologies that are
complementary to our own. Pending these uses, we expect to invest the net
proceeds in short-term, investment-grade securities. The precise amount and
timing of the application of proceeds from the sale of securities will depend on
our funding requirements and the availability and cost of other funds at the
time of sale. Allocation of proceeds of a particular series of securities, or
the principal reason for the offering if no allocation has been made, will be
described in the applicable prospectus supplement or in any related free writing
prospectus.
DESCRIPTION
OF OUR CAPITAL STOCK
Authorized
and Outstanding Capital Stock
Under our
certificate of incorporation, as amended, our authorized capital stock consists
of 150,000,000 shares of common stock, par value $0.001 per share and 15,000,000
shares of preferred stock, par value $0.001 per share. As of October 6, 2009,
there were approximately 18.8 million shares of common stock outstanding,
3,321,916 shares of common stock reserved for issuance upon exercise of
outstanding stock options and warrants to purchase common stock, and no shares
of preferred stock outstanding.
The
following summary description of our capital stock is based on the applicable
provisions of the Delaware General Corporation Law, or DGCL, and on the
provisions of our certificate of incorporation, as amended and our bylaws, as
amended. This information is qualified entirely by reference to the applicable
provisions of the Delaware General Corporation Law and our certificate of
incorporation, as amended, and our bylaws, as amended. For information on how to
obtain copies of such documents, please refer to the heading “Where You Can Find
More Information” in this prospectus.
Common
Stock
Dividend
Rights
Dividends
from our capital stock, subject to the provisions of our certificate of
incorporation, as amended, and applicable law, if any, may be declared by our
board of directors pursuant to law at any regular or annual meeting. Dividends
may be paid in cash, in property, or in shares of the capital stock, subject to
the provisions of the certificate of incorporation, as amended, and applicable
law.
Voting
Rights
For the
purpose of determining those stockholders entitled to vote at any meeting of our
stockholders, except as otherwise provided by law, only persons in whose names
stand on the stock records of the corporation on the record date, as provided in
Section 12 of our bylaws, as amended, shall be entitled to vote at any
meeting of stockholders. Every person entitled to vote shall have the right to
do so either in person, by remote communication, if applicable, or by an agent
or agents authorized by a proxy granted in accordance with Delaware law. An
agent so appointed need not be a stockholder. No proxy shall be voted after
three (3) years from its date of creation unless the proxy provides for a
longer period. Each share of our common stock has identical rights and
privileges in every respect.
Our
bylaws, as amended, provide that holders of shares of our common stock have the
power to adopt, amend or repeal the bylaws of the corporation; provided, that in
addition to any vote of the holders of any class or series of stock of the
corporation required by law or by our certificate of incorporation, as amended,
such action by stockholders shall require the affirmative vote of the holders of
at least 66-2/3% of the voting power of all of the then-outstanding shares of
our capital stock entitled to vote generally in the election of directors,
voting together as a single class. In addition, our certificate of
incorporation, as amended, and bylaws, as amended, provide that a director may
be removed at any time without cause by the affirmative vote of the holders of
66-2/3% of all of our then-outstanding shares of voting stock entitled to vote
at an election of directors.
No
Preemptive or Similar Rights
Our
common stock is not entitled to preemptive rights and is not subject to
conversion or redemption.
Right
to Receive Liquidation Distributions
If we
voluntarily or involuntarily liquidate, dissolve or wind-up, the holders of our
common stock will be entitled to receive after distribution in full of the
preferential amounts, if any, to be distributed to the holders of preferred
stock or any series of preferred stock, all of the remaining assets available
for distribution ratably in proportion to the number of shares of our common
stock held by them. Holders of our common stock have no preferences or any
preemptive conversion or exchange rights. Our outstanding common stock is fully
paid and non-assessable. The rights, 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 our preferred stock, which our board of
directors may designate and issue in the future.
Anti-Takeover
Provisions
Under the
provisions of the DGCL, our certificate of incorporation, as amended, and
bylaws, as amended, may have the effect of delaying, deferring, or discouraging
another person from acquiring control of us. Such provisions could limit the
price that some investors might be willing to pay in the future for our common
stock. These provisions of the DGCL and our certificate of incorporation, as
amended, and bylaws, as amended, may also have the effect of discouraging or
preventing certain types of transactions involving an actual or threatened
change of control of us, including unsolicited takeover attempts, even though
such a transaction may offer our stockholders the opportunity to sell their
stock at a price above the prevailing market price.
We are
subject to Section 203 of the DGCL, which, subject to certain exceptions,
prohibits a Delaware corporation from engaging in any “business combination”
with an “interested stockholder” for a period of three years following the time
that such stockholder became an interested stockholder, unless:
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the
board of directors of the corporation approves either the business
combination or the transaction that resulted in the stockholder becoming
an interested stockholder, prior to the time the interested stockholder
attained that status;
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upon
the closing of the transaction that 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 (a) by persons who are
directors or officers and (b) by 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 at
least two-thirds of the outstanding voting stock that is not owned by the
interested stockholder.
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With
certain exceptions, an “interested stockholder” is a person or group who or
which owns 15% or more of the corporation’s outstanding voting stock (including
any rights to acquire stock pursuant to an option, warrant, agreement,
arrangement or understanding, or upon the exercise of conversion or exchange
rights, and stock with respect to which the person has voting rights only), or
is an affiliate or associate of the corporation and was the owner of 15% or more
of such voting stock at any time within the previous three years.
In
general, Section 203 defines a business combination to
include:
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any
merger or consolidation involving the corporation and the interested
stockholder;
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any
sale, transfer, pledge or other disposition of 10% or more of the assets
of the corporation involving the interested
stockholder;
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subject
to certain exceptions, any transaction that results in the issuance or
transfer by the corporation of any stock of the corporation to the
interested stockholder;
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any
transaction involving the corporation that has the effect of increasing
the proportionate share of the stock or any class or series of the
corporation beneficially owned by the interested
stockholder; or
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the
receipt by the interested stockholder of the benefit of any loans,
advances, guarantees, pledges or other financial benefits provided by or
through the corporation.
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A
Delaware corporation may “opt out” of this provision with an express provision
in its original certificate of incorporation or an express provision in its
amended and restated certificate of incorporation or bylaws resulting from a
stockholders’ amendment approved by at least a majority of the outstanding
voting shares. However, we have not “opted out” of this provision.
Section 203 could prohibit or delay mergers or other takeover or
change-in-control attempts and, accordingly, may discourage attempts to acquire
us.
Our
certificate of incorporation, as amended, and bylaws, as amended, provide that
its board will have one class of directors serving concurrent, one-year terms.
Subject to the rights of the holders of any outstanding series of our preferred
stock, our certificate of incorporation, as amended, authorizes only our board
of directors to fill vacancies, including newly created directorships.
Accordingly, this provision could prevent a stockholder from obtaining majority
representation on the board of directors by enlarging the board of directors and
filling the new directorships with its own nominees. Our certificate of
incorporation, as amended, also provides that directors may be removed by
stockholders for cause by the affirmative vote of the holders of a majority of
the outstanding shares of voting stock or without cause by the affirmative vote
of the holders of 66-2/3% of the outstanding shares of voting
stock.
Our
certificate of incorporation, as amended, also provides that stockholders may
not take action by written consent, but may only take action at duly called
annual or special meetings of stockholders. Our certificate of incorporation, as
amended, further provides that special meetings of our stockholders may be
called only by the chairman of the board of directors, the chief executive
officer or a majority of the board of directors. This limitation on the right of
stockholders to call a special meeting could make it more difficult for
stockholders to initiate actions that are opposed by our board of directors.
These actions could include the removal of an incumbent director or the election
of a stockholder nominee as a director. They could also include the
implementation of a rule requiring stockholder ratification of specific
defensive strategies that have been adopted by our board of directors with
respect to unsolicited takeover bids. In addition, the limited ability of our
stockholders to call a special meeting of stockholders may make it more
difficult to change the existing board and management.
Our
bylaws, as amended, provide that stockholders seeking to bring business before
an annual meeting of stockholders, or to nominate candidates for election as
directors at an annual meeting of stockholders, must provide timely notice
thereof in writing. To be timely, a stockholder’s notice must be delivered to or
mailed and received at our principal executive offices not less than 120 days
prior to the date of our annual meeting. Our bylaws, as amended, also specify
certain requirements as to the form and content of a stockholder’s notice. These
provisions may preclude stockholders from bringing matters before an annual
meeting of stockholders or from making nominations for directors at an annual
meeting of stockholders.
The authorized but unissued shares of
our common stock and preferred stock are available for future issuance without
stockholder approval. These additional shares may be utilized for a variety of
corporate purposes, including future public offerings to raise additional
capital, corporate acquisitions, employee benefit plans and “poison pill” rights plans.
This could result in our management being able to issue more shares without
further stockholder approval and could render more difficult or discourage an
attempt to obtain control of us by means of a proxy contest, tender offer,
merger or otherwise.
Transfer
Agent
The
transfer agent for our common stock is American Stock Transfer & Trust
Company.
Listing
Our
common stock is listed on the NASDAQ Capital Market under the symbol
“RPTPD.”
Preferred
Stock
Our board
of directors is authorized to provide for the issuance of shares of preferred
stock in one or more series, and to fix for each series voting rights, if any,
designations, preferences and relative, participating, optional or other special
rights and such qualifications, limitations or restrictions as provided in a
resolution or resolutions adopted by our board of directors. Our board of
directors has authorized the issuance of Series A participating preferred stock
which includes terms and conditions which could discourage a takeover or other
transaction that holders of some or a majority of common stock might believe to
be in their best interests. In addition, our board of directors may authorize
the issuance of preferred stock in which holders of preferred stock might
receive a premium for their shares over the then market price. We have no
present plans to issue any shares of preferred stock.
Series
A Participating Preferred Stock
Each
outstanding share of our common stock has attached to it one preferred share
purchase right that entitles the registered holder to purchase from us a unit of
one one-thousandth of a share of its Series A participating preferred stock,
which is referred to herein as the Junior Preferred Stock, at a price of $15.00
per unit. The description and terms of the rights are set forth in a rights
agreement dated as of May 13, 2005, as amended, by and between American
Stock Transfer & Trust Company, as rights agent, and us, which is
referred to herein as the Raptor Rights Agreement.
Until the
earlier to occur of (i) the close of business on the tenth day after a
public announcement that a person or group of affiliated or associated persons
has acquired beneficial ownership of 15% or more of our outstanding common
stock, subject to certain exceptions, or (ii) 10 business days (or such
later date as may be determined by action of our board of directors prior to
such time as any person becomes an acquiring person) following the commencement
of, or announcement of an intention to make, a tender offer or exchange offer
the consummation of which would result in the beneficial ownership by a person
or group of 15% or more of such outstanding common stock (the earlier of such
dates is the distribution date), the rights will be evidenced by our common
stock certificates.
The
Raptor Rights Agreement provides that, until the distribution date, the rights
will be transferred with and only with our common stock. Until the distribution
date (or earlier redemption or expiration of the rights), our common stock
certificates, upon transfer or new issuance of common stock will contain a
notation incorporating the Raptor Rights Agreement by reference. Until the
distribution date (or earlier redemption or expiration of the rights), the
surrender for transfer of any certificates of our common stock will also
constitute the transfer of the rights associated with the common stock
represented by such certificate. As soon as practicable following the
distribution date, if any, separate certificates evidencing the rights will be
mailed to holders of record of our common stock as of the close of business on
the distribution date and such separate rights certificates alone will evidence
the rights.
The
rights are not exercisable until the distribution date. The rights will expire
at the close of business on May 15, 2015 unless that final expiration date
is extended or unless the rights are earlier redeemed or exchanged by us, in
each case as described below.
The
purchase price payable, and the number of units of Junior Preferred Stock or
other securities or property issuable, upon exercise of the rights are subject
to adjustment from time to time to prevent dilution (a) in the event of a
stock dividend on, or a subdivision, combination or reclassification of, the
Junior Preferred Stock, (b) upon the grant to holders of the units of
Junior Preferred Stock of certain rights or warrants to subscribe for or
purchase units of Junior Preferred Stock at a price, or securities convertible
into units of Junior Preferred Stock with a conversion price, less than the then
current market price of the units of Junior Preferred Stock, or (c) upon
the distribution to holders of the units of Junior Preferred Stock of evidences
of indebtedness or assets (excluding regular periodic cash dividends paid out of
earnings or retained earnings or dividends payable in units of Junior Preferred
Stock) or of subscription rights or warrants other than those referred to
above.
The
number of outstanding rights and the number of units of Junior Preferred Stock
issuable upon exercise of each right are also subject to adjustment in the event
of a stock split of our common stock or a stock dividend on the common stock
payable in common stock or subdivisions, consolidations or combinations of the
common stock occurring, in any such case, prior to the distribution
date.
The
Junior Preferred Stock purchasable upon exercise of the rights will not be
redeemable. Each share of Junior Preferred Stock will be entitled to an
aggregate dividend of 1,000 times the dividend declared per share of our common
stock. In the event of liquidation, the holders of the shares of Junior
Preferred Stock will be entitled to an aggregate payment of 1,000 times the
payment made per share of our common stock. Each share of Junior Preferred Stock
will have 1,000 votes, voting together with our common stock. Finally, in the
event of any merger, consolidation or other transaction in which shares of our
common stock are exchanged, each share of Junior Preferred Stock will be
exchanged or changed in an amount per share equal to 1,000 times the amount
received per share of common stock. These rights are protected by customary
anti-dilution provisions.
Because
of the nature of the dividend, liquidation and voting rights, the value of each
unit of Junior Preferred Stock purchasable upon exercise of each right should
approximate the value of one share of common stock.
If, after
the rights become exercisable, we are acquired in a merger or other business
combination transaction with an acquiring person or one of its affiliates, or
50% or more of our consolidated assets or earning power are sold to an acquiring
person or one of its affiliates, proper provision will be made so that each
holder of a right will thereafter have the right to receive, upon exercise
thereof at the then current exercise price of the right, that number of shares
of common stock of the acquiring company which at the time of such transaction
will have a market value of two times the exercise price of the
right.
If any
person or group of affiliated or associated persons becomes the beneficial owner
of 15% or more of the outstanding shares of our common stock, subject to certain
exceptions, proper provision will be made so that each holder of a right, other
than rights beneficially owned by the acquiring person (which will thereafter be
unexercisable), will have the right to receive upon exercise that number of
shares of our common stock or units of Junior Preferred Stock (or cash, other
securities or property) having a market value of two times the exercise price of
the right.
At any
time after the acquisition by a person or group of affiliated or associated
persons of beneficial ownership of 15% or more of the outstanding shares of our
common stock, subject to certain exceptions, and prior to the acquisition by
such person or group of 50% or more of the outstanding common stock, our board
of directors may exchange the rights (other than rights owned by such person or
group which have become void), in whole or in part, at an exchange ratio per
unit of Junior Preferred Stock equal to the purchase price divided by the then
current market price per unit of Junior Preferred Stock on the earlier of
(i) the date on which any person becomes an acquiring person and
(ii) the date on which a tender or exchange offer is announced which, if
consummated would result in the offerer being the beneficial owner of 15% or
more of the shares of our common stock then outstanding.
With
certain exceptions, no adjustment in the purchase price will be required until
cumulative adjustments require an adjustment of at least 1% in the purchase
price. No fractional shares of Junior Preferred Stock will be issued (other than
fractions which are integral multiples of one one-thousandth of a share of
Junior Preferred Stock, which may, at our election, be evidenced by depositary
receipts) and, in lieu thereof, an adjustment in cash will be made based on the
market price of the units of Junior Preferred Stock on the last trading day
prior to the date of exercise.
At any
time on or prior to the earlier of (i) the close of business on the tenth
day after a public announcement that a person or group of affiliated or
associated persons acquires beneficial ownership of 15% or more of the
outstanding our common stock (unless the board of directors extends the ten day
period) or (ii) the tenth business day after a person commences, or
announces its intention to commence, a tender offer or exchange offer that would
result in the bidder’s beneficial ownership of 15% or more of the shares of our
common stock, our board of directors may redeem the rights in whole, but not in
part, at a price of $0.01 per right. The redemption of the rights may be made
effective at such time, on such basis and with such conditions as our board of
directors in its sole discretion may establish. Immediately upon any redemption
of the rights, the right to exercise the rights will terminate and the only
right of the holders of rights will receive the redemption price. The rights are
also redeemable under other circumstances as specified in the Raptor Rights
Agreement.
The terms
of the rights may be amended by our board of directors without the consent of
the holders of the rights except that from and after such time that there is an
acquiring person no amendment may adversely affect the interests of the holders
of the rights.
Until a
right is exercised, the holder of a right will have no rights by virtue of
ownership as our stockholder, other than those accruing as a result of the
holder’s ownership in our common stock, including, without limitation, the right
to vote or to receive dividends.
The
rights have certain anti-takeover effects. The rights will cause substantial
dilution to a person or group that attempts to acquire us on terms not approved
by our board of directors, except pursuant to an offer conditioned on a
substantial number of rights being acquired. The rights should not interfere
with any merger or other business combination approved by our board of directors
since the rights may be redeemed by us at the redemption price prior to the
occurrence of a distribution date. The foregoing description of the rights is
qualified in its entirety by reference to the Raptor Rights
Agreement.
DESCRIPTION OF DEBT
SECURITIES
The
following description, together with the additional information we include in
any applicable prospectus supplement, summarizes the material features, terms and
provisions of any debt securities that we may offer under this
prospectus. This
summary does not purport to be exhaustive and may not contain all the
information that is important to you. Therefore, you should read the applicable
prospectus supplement relating to those debt securities and any other offering
materials that we may provide. We may issue debt securities, in one or
more series, as either senior or subordinated debt or as senior or subordinated
convertible debt. Unless otherwise stated in
the applicable prospectus supplement, we will not be limited in the amount of
debt securities that we may issue, and neither the senior debt securities nor
the subordinated debt securities will be secured by any of our property or
assets. Thus, by owning debt securities, you are one of our unsecured creditors.
While the terms we have summarized below will apply generally to any debt
securities that we may offer under this prospectus, we will describe the
particular terms of any debt securities that we may offer in more detail in the
applicable prospectus supplement. The terms of any debt securities offered under
a prospectus supplement may differ from the terms described below. For any debt
securities that we may offer, an indenture (and any relevant supplemental
indenture) will contain additional important terms and provisions and will be
incorporated by reference as an exhibit to the registration statement that
includes this prospectus, or as an exhibit to a current report on Form 8-K,
incorporated by reference in this prospectus. Unless the context requires
otherwise, whenever we refer to the indentures, we also are referring to any
supplemental indentures that specify the terms of a particular series of debt
securities.
We
conduct substantially all of our operations though subsidiaries. As a result,
claims of holders of debt securities will generally have a junior position to
claims of creditors of our subsidiaries, except to the extent that we may be
recognized as a creditor of those subsidiaries. In addition, our right to
participate as a stockholder in any distribution of assets of any subsidiary
(and thus the ability of holders of debt securities to benefit from such
distribution as our creditors) is junior to creditors of each
subsidiary.
We may issue senior debt
securities or subordinated debt securities under one or separate indentures,
which may be supplemented or amended from time to time. Senior debt securities
will be issued under one or more senior indentures that we will enter
into with the trustees named in such senior indentures and subordinated debt
securities will be issued under one or more subordinated indentures that
we will enter into with the trustees named in such subordinated indentures. Any senior debt
indentures and subordinated debt indentures are referred to individually in this
prospectus as the “indenture” and collectively as the “indentures.” The
particular terms of a series of debt securities will be described in an
prospectus supplement relating to such series of debt securities. Any
indentures will be subject to, governed by and qualified under, the Trust
Indenture Act of 1939, as amended, and may be supplemented or amended from time
to time following their execution. We use the term “debenture trustee” to refer
to either a trustee under a senior indenture or a trustee under a subordinated
indenture, as applicable. We have filed forms of indentures to the registration
statement of which this prospectus is a part, and supplemental indentures and
forms of debt securities containing the terms of the debt securities being
offered will be filed as exhibits to the registration statement of which this
prospectus is a part or will be incorporated by reference from reports that we
file with the SEC..
Any
indentures will contain the full legal text of the matters described in this
section of the prospectus. Because this section is a summary, it does not
describe every aspect of the debt securities or any applicable indentures. This
summary is therefore subject to and is qualified in its entirety by reference to
all the provisions of any applicable indenture, including any definitions of
terms used in such indenture. Your rights will be defined by the terms of any
applicable indenture, not the summary provided herein. This summary is also
subject to and qualified by reference to the description of the particular terms
of a particular series of debt securities described in the applicable prospectus
supplement or supplements.
The debt
securities may be denominated and payable in U.S. dollars. We may also issue
debt securities, from time to time, with the principal amount, interest or other
amounts payable on any relevant payment date to be determined by reference to
one or more currency exchange rates, securities or baskets of securities,
commodity prices, indices or any other financial, economic or other measure or
instrument, including the occurrence or non-occurrence of any event or
circumstance. In addition, we may issue debt securities as part of any units
issued by us. All references in this prospectus or any prospectus supplement to
other amounts will include premiums, if any, other cash amounts payable under
the applicable indenture, and the delivery of securities or baskets of
securities under the terms of the debt securities. Debt securities may bear
interest at a fixed rate, which may be zero, or a floating rate.
Some of
the debt securities may be issued as original issue discount debt securities.
Original issue discount securities bear no interest or bear interest at below
market rates and will be sold at a discount below their stated principal amount.
A prospectus supplement relating to an issue of original issue discount
securities will contain information relating to United States federal income
tax, accounting, and other special considerations applicable to original issue
discount securities.
We will
set forth in the applicable prospectus supplement the terms, if any, on which a
series of debt securities may be convertible into or exchangeable for our
preferred stock, common stock or other securities. We will include provisions as
to whether conversion or exchange is mandatory, at the option of the holder or
at our option. We may include provisions pursuant to which the number of shares
of our preferred stock, common stock or other securities that holders of the
series of debt securities receive would be subject to adjustment.
We will
generally have no obligation to repurchase, redeem, or change the terms of debt
securities upon any event (including a merger, consolidation, change in control
or disposition of substantially all of our assets) that might have an adverse
effect on our credit quality.
The
following summaries of material provisions of the senior debt securities, the
subordinated debt securities and the indentures are subject to, and qualified in
their entirety by reference to, all of the provisions of the indenture
applicable to a particular series of debt securities. We urge you to read the
applicable prospectus supplements and any related free writing prospectuses
related to the debt securities that we may offer under this prospectus, as well
as the complete indentures that contains the terms of the debt securities.
Except as we may otherwise indicate, the terms of the senior indenture and the
subordinated indenture are identical.
General
We
will describe in the applicable prospectus supplement the terms of the series of
debt securities being offered, including:
• the
title;
• the
principal amount being offered, and if a series, the total amount authorized and
the total amount outstanding;
• any
limit on the amount that may be issued;
• whether
or not we will issue the series of debt securities in global form, the terms and
who the depositary will be;
• the
maturity date;
• the
principal amount due at maturity;
• whether
and under what circumstances, if any, we will pay additional amounts on any debt
securities held by a person who is not a United States person for tax purposes,
and whether we can redeem the debt securities if we have to pay such additional
amounts;
• the
annual interest rate, which may be fixed or variable, or the method for
determining the rate and the date interest will begin to accrue, the dates
interest will be payable and the regular record dates for interest payment dates
or the method for determining such dates;
• whether
or not the debt securities will be convertible into shares of common stock,
preferred stock or other securities and, if so, the terms of such
conversion;
• whether
or not the debt securities will be secured or unsecured, and the terms of any
secured debt;
• the
terms of the subordination of any series of subordinated debt;
• the
place where payments will be payable;
• restrictions
on transfer, sale or other assignment, if any;
• our
right, if any, to defer payment of interest and the maximum length of any such
deferral period;
• the
date, if any, after which, and the price at which, we may, at our option, redeem
the series of debt securities pursuant to any optional or provisional redemption
provisions and the terms of those redemption provisions;
• the
date, if any, on which, and the price at which we are obligated, pursuant to any
mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or
at the holder’s option to purchase, the series of debt securities and the
currency or currency unit in which the debt securities are payable;
• whether
the indenture will restrict our ability and/or the ability of our subsidiaries
to:
• incur
additional indebtedness;
• issue additional
securities;
• create
liens;
• pay
dividends and make distributions in respect of our capital stock and the capital
stock of our subsidiaries;
• redeem
capital stock;
• place
restrictions on our subsidiaries’ ability to pay dividends, make distributions
or transfer assets;
• make
investments or other restricted payments;
• sell
or otherwise dispose of assets;
• enter
into sale-leaseback transactions;
• engage
in transactions with stockholders and affiliates;
• issue
or sell stock of our subsidiaries;
• effect
a consolidation or merger;
• whether
the indenture will require us to maintain any interest coverage, fixed charge,
cash flow-based, asset-based or other financial ratios;
• a
discussion of any material United States federal income tax considerations
applicable to the debt securities;
• information
describing any book-entry features;
• provisions
for a sinking fund purchase or other analogous fund, if any;
• the
applicability of the provisions in the indenture on discharge;
• whether
the debt securities are to be offered at a price such that they will be deemed
to be offered at an “original issue discount” as defined in paragraph (a)
of Section 1273 of the Internal Revenue Code;
• the
currency of payment of debt securities if other than U.S. dollars and the manner
of determining the equivalent amount in U.S. dollars;
• the
denominations in which we will issue the series of debt securities, if other
than denominations of $1,000 and any integral multiple thereof;
• whether
we and/or the debenture trustee may change an indenture without the consent of
any holders;
• the
form of debt security and how it may be exchanged and transferred;
• the
governing law of the indentures and debt securities;
• our
ability to be discharged from our obligations with respect to one or more series
of debt securities;
• the
description of the debenture trustee and paying agent, and the method of
payments; and
• any
other specific terms, preferences, rights or limitations of, or restrictions on,
the debt securities, including any additional events of default, acceleration
with or without notice, indemnity or covenants provided with respect to the debt
securities, rights to institute a proceeding under the indentures and any terms
that may be required by us or advisable under applicable laws or
regulations.
Conversion
or Exchange Rights
We
will set forth in the prospectus supplement the terms on which a series of debt
securities may be convertible into or exchangeable for our common stock or our
other securities. We will include provisions as to whether conversion or
exchange is mandatory, at the option of the holder or at our option. We may
include provisions pursuant to which the number of shares of our common stock or
our other securities that the holders of the series of debt securities receive
would be subject to adjustment.
Consolidation,
Merger or Sale
Unless
we provide otherwise in the prospectus supplement applicable to a particular
series of debt securities, the indentures will not contain any covenant that
restricts our ability to merge or consolidate, or sell, convey, transfer or
otherwise dispose of all or substantially all of our assets. However, any
successor to or acquirer of such assets must assume all of our obligations under
the indentures or the debt securities, as appropriate. If the debt securities
are convertible into or exchangeable for our other securities or securities of
other entities, the person with whom we consolidate or merge or to whom we sell
all of our property must make provisions for the conversion of the debt
securities into securities that the holders of the debt securities would have
received if they had converted the debt securities before the consolidation,
merger or sale.
DESCRIPTION
OF WARRANTS
We
may issue warrants for the purchase of common stock, preferred stock and/or debt
securities, in one or more series. We may issue warrants independently or
together with common stock, preferred stock and/or debt securities, and the
warrants may be attached to or separate from these securities. While the terms
summarized below will apply generally to any warrants that we may offer, we will
describe the particular terms of any series of warrants in more detail in the
applicable prospectus supplement. The terms of any warrants offered under a
prospectus supplement may differ from the terms described below.
We will file as exhibits to the registration statement of which this prospectus
is a part, or will incorporate by reference from reports that we file with the
SEC, the form of warrant agreement that describes the terms of the particular
series of warrants we are offering before the issuance of the related series of
units. The following summaries of material provisions of the warrants and the
warrant agreements are subject to, and qualified in their entirety by reference
to, all the provisions of the warrant agreement and warrant certificate
applicable to the particular series of warrants that we may offer under this
prospectus. We urge you to read the applicable prospectus supplements related to
the particular series of units that it may offer under this prospectus, as well
as any related free writing prospectuses, and the complete warrant agreements
that contain the terms of the warrants.
General
We
will describe in the applicable prospectus supplement the terms of the series of
warrants being offered, including:
• the
offering price of securities that include such warrants and aggregate number of
warrants offered;
• if
applicable, the designation and terms of the securities with which the warrants
are issued and the number of warrants issued with each such security or each
principal amount of such security;
• in
the case of warrants to purchase debt securities, the principal amount of debt
securities purchasable upon exercise of one warrantand the price at, and currency in which, this
principal amount of debt securities may be purchased upon such
exercise;
• in
the case of warrants to purchase common stock or preferred stock, the number of
shares of common stock or preferred stock, as the case may be, purchasable upon
the exercise of one warrant and the price at which these shares may be purchased
upon such exercise;
• the
effect of any merger, consolidation, sale or other disposition of our business
on the warrant agreements and the warrants;
• the
terms of any rights to redeem or call the warrants;
• any
provisions for changes to or adjustments in the exercise price or number of
securities issuable upon exercise of the warrants;
• the
dates on which the right to exercise the warrants will commence and
expire;
• the
manner in which the warrant agreements may be modified;
• a
discussion of any material or special United States federal income tax
consequences of holding or exercising the warrants;
• the
terms of the securities issuable upon exercise of the warrants; and
• any
other specific terms, preferences, rights or limitations of or restrictions on
the warrants.
Before exercising their
warrants, holders of warrants will not have any of the rights of holders of the
securities purchasable upon such exercise, including:
• in
the case of warrants to purchase debt securities, the right to receive payments
of principal of, or premium, if any, or interest on, the debt securities
purchasable upon exercise or to enforce covenants in the applicable indenture;
or
• in
the case of warrants to purchase common stock or preferred stock, the right to
receive dividends, if any, or payments upon ourliquidation, dissolution or winding up or to
exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in
the applicable prospectus supplement at the exercise price that we describe in
the applicable prospectus supplement. Holders of the warrants may exercise the
warrants at any time up to the specified time on the expiration date that we set
forth in the applicable prospectus supplement. After the close of business on
the expiration date, unexercised warrants will become void.
Holders
of the warrants may exercise the warrants by delivering the warrant agreement
representing the warrants to be exercised together with specified information,
and paying the required amount to us in immediately available funds, as provided
in the applicable prospectus supplement.
Upon
receipt of the required payment and the warrant agreement properly completed and
duly executed at our or any other office indicated in the applicable prospectus
supplement, we will issue and deliver the securities purchasable upon such
exercise. If fewer than all of the warrants represented by the warrant agreement
are exercised, then we will issue a new warrant agreement for the remaining
amount of warrants. Holders of the warrants may surrender securities as all or
part of the exercise price for warrants.
Enforceability
of Rights by Holders of Warrants
Each
warrant agent will act solely as our agent under the applicable warrant
agreement and will not assume any obligation or relationship of agency or trust
with any holder of any warrant. A single bank or trust company may act as
warrant agent for more than one issue of warrants. A warrant agent will have no
duty or responsibility in case of any default by us under the applicable warrant
agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a
warrant may, without the consent of the related warrant agent or the holder of
any other warrant, enforce by appropriate legal action its right to exercise,
and receive the securities purchasable upon exercise of, its
warrants.
Governing
Law
Unless
we provide otherwise in the applicable prospectus supplement, the warrant
agreements will be governed by and construed in accordance with the laws of the
State of Delaware.
DESCRIPTION OF
UNITS
We
may issue, in one more series, units consisting of common stock, preferred
stock, debt securities and/or warrants for the purchase of common stock,
preferred stock and/or debt securities in any combination. While the terms we
have summarized below will apply generally to any units that we may offer under
this prospectus, we will describe the particular terms of any series of units in
more detail in the applicable prospectus supplement. The terms of any units
offered under a prospectus supplement may differ from the terms described
below.
We
will file as exhibits to the registration statement of which this prospectus is
a part, or will incorporate by reference from reports that we file with the SEC,
the form of unit agreement that describes the terms of the series of units we
are offering, and any supplemental agreements, before the issuance of the
related series of units. The following summaries of material terms and
provisions of the units are subject to, and qualified in their entirety by
reference to, all the provisions of the unit agreement and any supplemental
agreements applicable to a particular series of units. We urge you to read the
applicable prospectus supplements related to the particular series of units that
we may offer under this prospectus, as well as any related free writing
prospectuses and the complete unit agreement and any supplemental agreements
that contain the terms of the units.
General
Each
unit will be issued so that the holder of the unit is also the holder of each
security included in the unit. Thus, the holder of a unit will have the rights
and obligations of a holder of each included security. The unit agreement under
which a unit is issued may provide that the securities included in the unit may
not be held or transferred separately, at any time or at any time before a
specified date.
We
will describe in the applicable prospectus supplement the terms of the series of
units being offered, including:
• the
designation and terms of the units and of the securities comprising the units,
including whether and under what circumstances those securities may be held or
transferred separately;
• any
provisions of the governing unit agreement that differ from those described
below; and
• any
provisions for the issuance, payment, settlement, transfer or exchange of the
units or of the securities comprising the units.
The
provisions described in this section, as well as those described under
“Description of Our Capital Stock,” “Description of Debt Securities” and
“Description of Warrants” will apply to each unit to the extent comprised of any
such security included in each unit, as well as the underlying, relevant
securities, respectively.
Issuance
in Series
We
may issue units in such amounts and in such numerous distinct series as we
determine.
Enforceability
of Rights by Holders of Units
Each unit agent will act solely as our
agent under the applicable unit agreement and will not assume any obligation or
relationship of agency or trust with any holder of any unit. A single bank or
trust company may act as unit agent for more than one series of units. A unit
agent will have no duty or responsibility in case of any default by us under the
applicable unit agreement or unit, including any duty or responsibility to
initiate any proceedings at law or otherwise, or to make any demand upon us. Any
holder of a unit may, without the consent of the related unit agent or the
holder of any other unit, enforce by appropriate legal action its rights as
holder under any security included in the unit.
Title
We,
and any unit agent and any of their agents, may treat the registered holder of
any unit certificate as an absolute owner of the units evidenced by that
certificate for any purpose and as the person entitled to exercise the rights
attaching to the units so requested, despite any notice to the contrary. See
“Legal Ownership of Securities” below.
LEGAL OWNERSHIP OF
SECURITIES
We
can issue securities in registered form to “holders” and “indirect holders” or
as global securities. We refer to those persons who have securities registered
in their own names on the books that we or any applicable trustee or depositary
maintain for this purpose as the “holders” of those securities. These persons
are the legal holders of the securities. We refer to those persons who,
indirectly through others, own beneficial interests in securities that are not
registered in their own names, as “indirect holders” of those securities. As
discussed below, indirect holders are not legal holders, and investors in
securities issued in book-entry form or in street name will be indirect
holders.
Book-Entry
Holders We may issue
securities in book-entry form only, as we will specify in the applicable
prospectus supplement. This means securities may be represented by one or more
global securities registered in the name of a financial institution that holds
them as depositary on behalf of other financial institutions that participate in
the depositary’s book-entry system. These participating institutions, which are
referred to as participants, in turn, hold beneficial interests in the
securities on behalf of themselves or their customers.
Only
the person in whose name a security is registered is recognized as the holder of
that security. Securities issued in global form will be registered in the name
of the depositary or its participants. Consequently, for securities issued in
global form, we will recognize only the depositary as the holder of the
securities, and we will make all payments on the securities to the depositary.
The depositary passes along the payments it receives to its participants, which
in turn pass the payments along to their customers who are the beneficial
owners. The depositary and its participants do so under agreements they have
made with one another or with their customers; they are not obligated to do so
under the terms of the securities.
As
a result, investors in a book-entry security will not own securities directly.
Instead, they will own beneficial interests in a global security, through a
bank, broker or other financial institution that participates in the
depositary’s book-entry system or holds an interest through a participant. As
long as the securities are issued in global form, investors will be indirect
holders, and not holders, of the securities.
Street
Name Holders
We
may terminate a global security or issue securities in non-global form. In these
cases, investors may choose to hold their securities in their own names or in
“street name.” Securities held by an investor in street name would be registered
in the name of a bank, broker or other financial institution that the investor
chooses, and the investor would hold only a beneficial interest in those
securities through an account he or she maintains at that
institution.
For
securities held in street name, we will recognize only the intermediary banks,
brokers and other financial institutions in whose names the securities are
registered as the holders of those securities, and will make all payments, if
any, on those securities to them. These institutions pass along the payments
they receive to their customers who are the beneficial owners, but only because
they agree to do so in their customer agreements or because they are legally
required to do so. Investors who hold securities in street name will be indirect
holders, not holders, of those securities.
Legal
Holders
Our
obligations, as well as the obligations of any applicable trustee and of any
third parties employed by us or a trustee, run only to the legal holders of the
securities. we do not have obligations to investors who hold beneficial
interests in global securities, in street name or by any other indirect means.
This will be the case whether an investor chooses to be an indirect holder of a
security or has no choice because we are issuing the securities only in global
form.
For
example, once we make a payment, if any, or give a notice to the holder, we have
no further responsibility for the payment or notice even if that holder is
required, under agreements with depositary participants or customers or by law,
to pass it along to the indirect holders but does not do so. Similarly, we may
want to obtain the approval of the holders to amend an indenture, to relieve us
of the consequences of a default or of our obligation to comply with a
particular provision of the indenture or for other purposes. In such an event,
we would seek approval only from the holders, and not the indirect holders, of
the securities. Whether and how the holders contact the indirect holders is up
to the holders.
Special
Considerations For Indirect Holders
If
you hold securities through a bank, broker or other financial institution,
either in book-entry form or in street name, you should check with your own
institution to find out:
• how
it handles securities payments and notices;
• whether
it imposes fees or charges;
• how
it would handle a request for the holders’ consent, if ever
required;
• whether
and how you can instruct it to send you securities registered in your own name
so you can be a holder, if that is permitted inthe future;
• how
it would exercise rights under the securities if there were a default or other
event triggering the need for holders to act to protect their interests;
and
• if
the securities are in book-entry form, how the depositary’s rules and procedures
will affect these matters.
Global
Securities
A
global security is a security that represents one or any other number of
individual securities held by a depositary. Generally, all securities
represented by the same global securities will have the same terms.
Each
security issued in book-entry form will be represented by a global security that
we deposit with and register in the name of a financial institution or its
nominee that we select. The financial institution that we select for this
purpose is called the depositary. Unless we specify otherwise in the applicable
prospectus supplement, The Depository Trust Company, New York, New York, known
as DTC, will be the depositary for all securities issued in book-entry
form.
A
global security may not be transferred to or registered in the name of anyone
other than the depositary, its nominee or a successor depositary, unless special
termination situations arise. We describe those situations below under “Special
Situations When a Global Security Will Be Terminated.” As a result of these
arrangements, the depositary, or its nominee, will be the sole registered owner
and holder of all securities represented by a global security, and investors
will be permitted to own only beneficial interests in a global security.
Beneficial interests must be held by means of an account with a broker, bank or
other financial institution that in turn has an account with the depositary or
with another institution that does. Thus, an investor whose security is
represented by a global security will not be a holder of the security, but only
an indirect holder of a beneficial interest in the global security.
If
the prospectus supplement for a particular security indicates that the security
will be issued in global form only, then the security will be represented by a
global security at all times unless and until the global security is terminated.
If termination occurs, we may issue the securities through another book-entry
clearing system or decide that the securities may no longer be held through any
book-entry clearing system.
Special
Considerations For Global Securities
The
rights of an indirect holder relating to a global security will be governed by
the account rules of the investor’s financial institution and of the depositary,
as well as general laws relating to securities transfers. We do not recognize an
indirect holder as a holder of securities but instead deal only with the
depositary that holds the global security.
If
securities are issued only in the form of a global security, an investor should
be aware of the following:
• an
investor cannot cause the securities to be registered in his or her name, and
cannot obtain non-global certificates for his or her interest in the securities,
except in the special situations described below;
• an
investor will be an indirect holder and must look to his or her own bank or
broker for payments on the securities and protection of his or her legal rights
relating to the securities, as described above;
• an
investor may not be able to sell interests in the securities to some insurance
companies and to other institutions that are required by law to own their
securities in non-book-entry form;
• an
investor may not be able to pledge his or her interest in a global security in
circumstances where certificates representing the securities must be delivered
to the lender or other beneficiary of the pledge in order for the pledge to be
effective;
• the
depositary’s policies, which may change from time to time, will govern payments,
transfers, exchanges and other matters relating to an investor’s interest in a
global security;
• we
and any applicable trustee have no responsibility for any aspect of the
depositary’s actions or for its records of ownership interests in a global
security, nor do we or any applicable trustee supervise the depositary in any
way;
• the
depositary may, and we understand that DTC will, require that those who purchase
and sell interests in a global security within its book-entry system use
immediately available funds, and your broker or bank may require you to do so as
well; and
• financial
institutions that participate in the depositary’s book-entry system, and through
which an investor holds its interest in a global security, may also have their
own policies affecting payments, notices and other matters relating to the
securities.
There
may be more than one financial intermediary in the chain of ownership for an
investor. We do not monitor and are not responsible for the actions of any of
those intermediaries.
Special
Situations When a Global Security Will Be Terminated
In
a few special situations described below, the global security will terminate and
interests in it will be exchanged for physical certificates representing those
interests. After that exchange, the choice of whether to hold securities
directly or in street name will be up to the investor. Investors must consult
their own banks or brokers to find out how to have their interests in securities
transferred to their own name, so that they will be direct holders. We have
described the rights of holders and street name investors above.
Unless
we provide otherwise in the applicable prospectus supplement, the global
security will terminate when the following special situations
occur:
• if
the depositary notifies us that it is unwilling, unable or no longer qualified
to continue as depositary for that global security and we do not appoint another
institution to act as depositary within 90 days;
• if
we notify any applicable trustee that we wish to terminate that global security;
or
• if
an event of default has occurred with regard to securities represented by that
global security and has not been cured or waived.
The
prospectus supplement may also list additional situations for terminating a
global security that would apply only to the particular series of securities
covered by the applicable prospectus supplement. When a global security
terminates, the depositary, and not us or any applicable trustee, is responsible
for deciding the names of the institutions that will be the initial direct
holders.
PLAN
OF DISTRIBUTION
Pursuant
to General Instruction I.B.6 of Form S-3, we are permitted to utilize the
registration statement of which this prospectus forms a part to sell a maximum
amount of securities equal to one-third of the aggregate market value of the
outstanding voting and non-voting common equity held by our non-affiliates in
any 12 month period. We may, from to time, offer the securities registered
hereby up to this maximum amount.
We
may sell the securities from time to time pursuant to underwritten public
offerings, negotiated transactions, block trades or a combination of these
methods. We may sell the securities to or through underwriters or dealers, with
or without an underwriting syndicate, through agents, or directly to one or more
purchasers or a combination of these methods. We may distribute securities from
time to time in one or more transactions:
• at
a fixed price or prices, which may be changed;
• at
market prices prevailing at the time of sale;
• at
prices related to such prevailing market prices; or
• at
negotiated prices or in competitively bid transactions.
A
prospectus supplement or supplements will describe the terms of the offering of
the securities, including:
• the
name or names of the underwriters, dealers or agents, if any, and the types and
amounts of securities underwritten or purchased by each of them;
• the
purchase price of the securities and the proceeds we will receive from the
sale;
• any
over-allotment options under which underwriters may purchase additional
securities from us;
• any
agency fees or underwriting discounts and other items constituting agents’ or
underwriters’ compensation;
• any
public offering price;
• any
discounts or concessions allowed or reallowed or paid to dealers;
and
• any
securities exchange or market on which the securities may be
listed.
Only
underwriters named in the prospectus supplement will be underwriters of the
securities offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the securities for their
own account and may resell the securities from time to time in one or more
transactions at a fixed public offering price or at varying prices determined at
the time of sale. The obligations of the underwriters to purchase the securities
will be subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through underwriting
syndicates represented by managing underwriters or by underwriters without a
syndicate. Subject to certain conditions, the underwriters will be obligated to
purchase all of the securities offered by the prospectus supplement, other than
securities covered by any over-allotment option. Any public offering price and
any discounts or concessions allowed or reallowed or paid to dealers may change
from time to time. We may use underwriters with whom we have a material
relationship. We will describe in the prospectus supplement, naming the
underwriter, the nature of any such relationship.
If
we use dealers in the sale of securities, we will sell securities to such
dealers as principals. The dealers may then resell the securities to the public
at varying prices to be determined by such dealers at the time of resale. We may
solicit offers to purchase the securities directly, and we may sell the
securities directly to institutional or other investors, who may be deemed
underwriters within the meaning of the Securities Act with respect to any
resales of those securities. The terms of these sales will be described in the
applicable prospectus supplement. If we use agents in the sale of securities,
unless otherwise indicated in the prospectus supplement, they will use their
reasonable best efforts to solicit purchases for the period of their
appointment. Unless otherwise indicated in a prospectus supplement, if we sell
directly, no underwriters, dealers or agents would be involved. We will not make
an offer of securities in any jurisdiction that does not permit such an
offer.
We
may sell securities directly or through agents we designate from time to time.
We will name any agent involved in the offering and sale of securities and will
describe any commissions we will pay the agent in the prospectus supplement.
Unless the prospectus supplement states otherwise, our agent will act on a
best-efforts basis for the period of its appointment.
We
may authorize underwriters, dealers, or agents to solicit offers by certain
types of
institutional investors or other purchasers to purchase our securities
from them at the public offering price set forth in the prospectus supplement
pursuant to delayed delivery contracts providing for payment and delivery on a
specified date in the future. The contracts will be subject to those conditions
set forth in the prospectus supplement, and the prospectus supplement will set
forth any commissions or discounts we pay for solicitation of these
contracts.
We
may provide agents and underwriters with indemnification against civil
liabilities, including liabilities under the Securities Act, or contribution
with respect to payments that the agents or underwriters may make with respect
to these liabilities. Agents and underwriters may engage in transactions with,
or perform services for, us in the ordinary course of business.
Unless
otherwise specified in an applicable prospectus supplement, each class or series
of securities will be a new issue with no established trading market, other than
our common stock, which is listed on the NASDAQ Capital Market under the symbol
“RPTPD.” Any common
stock sold pursuant to a prospectus supplement will be listed on the
NASDAQ Capital Market, subject to official
notice of issuance. We may elect to list any other class or series of
securities on any exchange, but we are not obligated to do so. It is possible
that one or more underwriters may make a market in a class or series of
securities, but the underwriters will not be obligated to do so and may
discontinue any market making at any time without notice. We cannot give any
assurance as to the liquidity of the trading market for any of the securities.
We cannot guarantee the liquidity of the trading markets for any
securities.
In
connection with any offering, the underwriters may purchase and sell securities
in the open market. Any underwriter may engage
in short sales, over-allotment, stabilizing transactions, short-covering
transactions and penalty bids in accordance with Regulation M under the
Exchange Act. Short sales involve the sale by the underwriters of a
greater number of securities than they are required to purchase in an offering.
Over-allotment
involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long
as the stabilizing bids do not exceed a specified maximum price and are
made for the purpose of preventing or retarding a decline in the market price of
the securities while an offering is in progress. Syndicate-covering or
other short-covering transactions involve purchases of the securities, either
through exercise of the over-allotment option or in the open market after the
distribution is completed, to cover short positions. Penalty bids permit the
underwriters to reclaim a selling concession from a dealer when the securities
originally sold by the dealer are purchased in a stabilizing or covering
transaction to cover short positions. These activities by the
underwriters may stabilize, maintain or otherwise affect the market price of the
securities. As a result, the price of the securities may be higher than the
price that otherwise might exist in the open market. If these activities are
commenced, they may be discontinued by the underwriters at any time. These
transactions may be effected on an exchange or automated quotation system, if
the securities are listed on an exchange or admitted for trading on an automated
quotation system, in the over-the-counter market, or otherwise.
Any
underwriters that are qualified market makers on the NASDAQ Capital Market may
engage in passive market making transactions in our common stock on the NASDAQ
Capital Market in accordance with Regulation M under the Exchange Act,
during the business day prior to the pricing of the offering, before the
commencement of offers or sales of the common stock. Passive market makers must
comply with applicable volume and price limitations and must be identified as
passive market makers. In general, a passive market maker must display its bid
at a price not in excess of the highest independent bid for such security; if
all independent bids are lowered below the passive market maker’s bid, however,
the passive market maker’s bid must then be lowered when certain purchase limits
are exceeded. Passive market making may stabilize the market price of the
securities at a level above that which might otherwise prevail in the open
market and, if commenced, may be discontinued at any time.
In
compliance with guidelines of the Financial Industry Regulatory Authority, or
FINRA, the maximum consideration or discount to be received by any FINRA member
or independent broker dealer may not exceed 8% of the aggregate amount of the
securities offered pursuant to this prospectus and any applicable prospectus
supplement.
We
may enter into derivative transactions with third parties, or sell securities
not covered by this prospectus to third parties in privately negotiated
transactions. If the applicable prospectus supplement indicates in connection
with those derivatives then the third parties may sell securities covered by
this prospectus and the applicable prospectus supplement, including in short
sale transactions. If so, the third party may use securities pledged by us or
borrowed from us or others to settle those sales or to close out any related
open borrowings of stock, and may use securities received from us in settlement
of those derivatives to close out any related open borrowings of securities. The
third party in such sale transactions will be an underwriter and will be
identified in the applicable prospectus supplement (or a post-effective
amendment).
LEGAL
MATTERS
Paul,
Hastings, Janofsky & Walker LLP, Los Angeles, California will pass upon the
validity of the securities being offered by this prospectus. Any underwriter,
dealer or agent may be advised about issues relating to any offering by its own
legal counsel. The name of the law firm or law firms advising any underwriters, dealers
or agents with respect to certain issues relating to any offering will be set
forth in the applicable prospectus supplement.
EXPERTS
Burr,
Pilger & Mayer, LLP, independent registered public accounting firm, has
audited the consolidated financial statements of Raptor Pharmaceuticals Corp.’s
included in Raptor Pharmaceuticals Corp.’s Annual Report on Form 10-K, for the
year ended August 31, 2008 as set forth in their report (which contains an
explanatory paragraph describing conditions that raise substantial doubt about
Raptor Pharmaceuticals Corp.’s ability to continue as a going concern as
described in Note 1 to such consolidated financial statements) which is
incorporated by reference in this prospectus and elsewhere in the registration
statement of Raptor Pharmaceutical Corp. Such consolidated financial statements
of Raptor Pharmaceuticals Corp. are incorporated by reference in reliance on
Burr, Pilger & Mayer, LLP’s reports, given on the authority of such firm as
experts in accounting and auditing. Burr, Pilger & Mayer, LLP are the
auditors for our fiscal year ended August 31, 2009.
Ernst
& Young LLP, independent registered public accounting firm, has audited the
consolidated financial statements of TorreyPines Therapeutics, Inc. included in
TorreyPines Therapeutics, Inc.’s Annual Report on Form 10-K, for the year ended
December 31, 2008 as set forth in their report (which contains an explanatory
paragraph describing conditions that raise substantial doubt about TorreyPines
Therapeutics, Inc.’s ability to continue as a going concern as described in Note
1 to such consolidated financial statements), which is incorporated by reference
in this prospectus and elsewhere in the registration statement of Raptor
Pharmaceutical Corp. Such consolidated financial statements of TorreyPines
Therapeutics, Inc. are incorporated by reference in reliance on Ernst &
Young LLP’s reports, given on the authority of such firm as experts in
accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We file
annual, quarterly and current reports, proxy statements and other information
with the SEC. You may read and copy any reports, statements or other information
that we files at the SEC’s Public Reference Room at 100 F Street, N.E.,
Washington, D.C. 20549 on official business days during the hours of 10AM to
3PM. 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 from commercial
document retrieval services and on the website maintained by the SEC at
http://www.sec.gov. Reports, proxy statements and other information concerning
us also may be inspected at the offices of the Financial Industry Regulatory
Authority, Inc., Listing Section, 1735 K Street, Washington, D.C. 20006.
You may also obtain free copies of the documents that we file with the SEC by
going to the Investors and Media section of our website, www.raptorpharma.com.
The information provided on our website is not part of this prospectus, and
therefore is not incorporated by reference.
We
have filed with the SEC a registration statement on Form S-3 relating to the
securities covered by this prospectus. This prospectus is a part of the
registration statement and does not contain all the information in the
registration statement. Whenever a reference is made in this prospectus to a
contract or other document, the reference is only a summary and you should refer
to the exhibits that are a part of the registration statement for a copy of the
contract or other document. You may review a copy of the registration statement
at the SEC’s Public Reference Room in Washington, D.C., as well as through the
SEC’s internet website.
The SEC
allows us to “incorporate by reference” the information we file with it, which
means that we can disclose important information to you by referring you to
another document that we have filed separately with the SEC. You should read the
information incorporated by reference because it is an important part of this
prospectus. Any
information incorporated by reference into this prospectus is considered to be
part of this prospectus from the date we file that document. We
incorporate by reference the following information or documents that we and our
wholly-owned subsidiary, Raptor Pharmaceuticals Corp., have filed with the SEC
(Commission File Nos. 000-25571 and 000-50720, respectively) which shall not include,
in each case, documents, or information deemed to have been furnished and not
filed in accordance with SEC rules:
• Raptor
Pharmaceuticals Corp.’s Annual Report of Form 10-K for the fiscal year ended
August 31, 2008 and two Forms 10-K/A filed with the SEC on October 30, 2008,
December 23, 2008 and April 20, 2009, respectively;
• Raptor
Pharmaceuticals Corp.’s Quarterly Report of Form 10-Q for the fiscal quarter
ended November 30, 2008 and Form 10-Q/A filed with the SEC on January 13, 2009
and April 20, 2009, respectively;
• Raptor
Pharmaceuticals Corp.’s Quarterly Report of Form 10-Q for our fiscal quarter
ended February 28, 2009 filed with the SEC on April 13, 2009;
• Raptor
Pharmaceuticals Corp.’s Quarterly Report of Form 10-Q for our fiscal quarter
ended May 31, 2009 filed with the SEC on July 15, 2009;
• Raptor
Pharmaceuticals Corp.’s Current Reports on Form 8-K filed with the SEC on
October 6, 2009, August 31, 2009, August 25, 2009, July 31, 2009, July 28, 2009,
July 24, 2009, June 23, 2009, June 9, 2009, May 1, 2009, April 14, 2009, January
5, 2009, December 9, 2008, December 1, 2008, November 12, 2008, November 10,
2008, November 6, 2008 and October 21, 2008;
• Our
Annual Report on Form 10-K for the year ended December 31, 2008 filed with the
SEC on March 27, 2009, as filed by TorreyPines Therapeutics, Inc.;
• Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 filed with
the SEC on May 1, 2009, as filed by TorreyPines Therapeutics, Inc.;
• Our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2009 filed with the
SEC on August 11, 2009, as filed by TorreyPines Therapeutics, Inc.;
• Raptor
Pharmaceuticals Corp.’s Joint Proxy Statement on Schedule 14A filed with the SEC
on June 19, 2009;
• Our
Current Report on Form 8-K/A filed with the SEC on October 7, 2009, our Current
Reports on Form 8-K filed with the SEC on October 5, 2009, and our Current
Reports on Form 8-K filed with the SEC, as filed by TorreyPines Therapeutics,
Inc., on July 31, 2009, July 28, 2009, July 22, 2009, June 17, 2009, May 29,
2009, May 1, 2009, April 24, 2009, April 2, 2009, March 31, 2009, March 27, 2009
and February 9, 2009;
• the
description of our common stock, which is registered under Section 12(b) of the
Exchange Act, in our registration statement on Form 10-SB filed with the SEC on
March 17, 1999, as amended by that registration statement on Form 10-SB/A filed
with the SEC on August 19, 1999, each as filed by TorreyPines Therapeutics,
Inc., which description has been updated by Raptor Pharmaceuticals Corp.’s Joint
Proxy Statement on Schedule 14A filed with the SEC on June 19, 2009 (See section
titled, “Description of TorreyPines’ Capital Stock”); and
• the
description of our preferred share purchase rights, which are registered under
Section 12 of the Exchange Act, in our registration statement on Form 8-A filed
with the SEC on May 16, 2005, as filed by TorreyPines Therapeutics, Inc., which
description has been updated by Raptor Pharmaceuticals Corp.’s Joint Proxy
Statement on Schedule 14A filed with the SEC on June 19, 2009 (See section
titled, “Description of TorreyPines’ Capital Stock”).
Any
information in any of the foregoing documents will automatically be deemed to be
modified or superseded to the extent that information in this prospectus or in a
later filed document or other report that is incorporated or deemed to be
incorporated herein by reference modifies or replaces such
information.
We also
incorporate by reference any future filings (other than current reports
furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such
form that are related to such items) made with the SEC pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act, until we file a post-effective
amendment that indicates the termination of the offering of the securities made
by this prospectus. Information in such future filings updates and supplements
the information provided in this prospectus. These documents include
proxy statements and periodic reports, such as Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, and, to the extent they are considered filed and
except as described above, Current Reports on Form 8-K. Any statements in
any such future filings will automatically be deemed to modify and supersede any
information in any document we previously filed with the SEC that is
incorporated or deemed to be incorporated herein by reference to the extent that
statements in the later filed document modify or replace such earlier
statements.
We will
provide to each person, including any beneficial owner, to whom a prospectus is
delivered, without charge upon written or oral request, a copy of any or all of
the documents that are incorporated by reference into this prospectus but not
delivered with the prospectus, including exhibits which are specifically
incorporated by reference into such documents. If you would like to request
documents from us, please send a request in writing or by telephone to us at the
following address:
|
Raptor
Pharmaceutical Corp.
9
Commercial Blvd., Suite 200
Novato,
CA 94949
(415)
382-1390
Attn:
Secretary
|
Information
on Our Website
Information
on any Raptor website, any subsection, page, or other subdivision of any Raptor
website, or any website linked to by content on any Raptor website, is not part
of this prospectus and you should not rely on that information unless that
information is also in this prospectus or incorporated by reference in this
prospectus.
Trademark
Notice
Raptor,
our logos and all of our product candidates and trade names are our registered
trademarks or our trademarks in the United States and in other select countries.
Other third-party logos and product/trade names are registered trademarks or
trade names of their respective companies.
PROSPECTUS
$30,000,000
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Units
November
5, 2009