e424b5
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-138893
Prospectus Supplement
(To Prospectus dated December 11, 2006)
Novavax, Inc.
1,094,891 SHARES
COMMON STOCK
We are offering directly to a single investor 1,094,891 shares of our common stock.
Our common stock is listed on the NASDAQ Global Market under the symbol NVAX. On June 29,
2009, the last reported sale price of our common stock on the NASDAQ Global Market was $2.50 per
share and the consolidated closing bid price was $2.42 per share.
Investing in our common stock involves a high degree of risk. You should carefully consider
the Risk Factors beginning on page S-4 of this prospectus supplement, which supercede in their
entirety the risk factors beginning on page 4 of the accompanying prospectus, before you make an
investment decision.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
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Per Share |
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Total |
Offering price |
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$ |
2.74 |
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$ |
3,000,001.34 |
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Proceeds, after expenses, to us |
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$ |
2.72 |
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$ |
2,975,000 |
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Dated June 30, 2009
TABLE OF CONTENTS
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Prospectus Supplement |
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S-1 |
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S-1 |
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S-3 |
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S-4 |
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S-26 |
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S-26 |
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S-27 |
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Prospectus |
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Novavax, Inc. |
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Risk Factors |
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About this Prospectus |
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Special Note Regarding Forward-Looking Statements |
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Use of Proceeds |
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Plan of Distribution |
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Description of Our Capital Stock |
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Description of Our Warrants |
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Description of Our Units |
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Dividend Policy |
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Legal Matters |
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Experts |
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Where You Can Find More Information |
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Incorporation of Certain Information By Reference |
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You should rely only on the information contained in this prospectus supplement, the
accompanying prospectus and the documents we incorporate by reference in this prospectus supplement
and the accompanying prospectus. We have not authorized anyone to provide you with information
different from that contained or incorporated by reference in this prospectus supplement and the
accompanying prospectus. If anyone provides you with different or inconsistent information, you
should not rely on it. You should assume that the information contained in this prospectus
supplement and the accompanying prospectus, as well as the information that we have filed with the
Securities and Exchange Commission, or the SEC, and incorporated by reference herein and therein,
is accurate only as of the date of the applicable document. This prospectus supplement and the
accompanying prospectus do not constitute an offer or solicitation by anyone in any jurisdiction in
which an offer or solicitation is not authorized or in which the person making an offer or
solicitation is not qualified to do so, or to anyone to whom it is unlawful to make an offer or
solicitation.
S-i
This prospectus supplement contains the terms of this offering. This prospectus supplement,
along with the documents incorporated by reference in this prospectus supplement and the
accompanying prospectus, may add, update or change information in the accompanying prospectus. If
information in this prospectus supplement, or the documents incorporated by reference in this
prospectus supplement, and the accompanying prospectus, is inconsistent with the accompanying
prospectus, this prospectus supplement, or the documents incorporated by reference in this
prospectus supplement and the accompanying prospectus, will apply and will supersede the
information in the accompanying prospectus.
The information contained in this prospectus supplement and the accompanying prospectus is
correct only as of the date on the cover, regardless of the date this prospectus supplement was
delivered to you or the date on which you acquired any of the shares.
S-ii
SPECIAL NOTE ON FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the documents we have filed with
the Securities and Exchange Commission, or SEC, that are incorporated herein by reference and that
are referenced under the section entitled Where You Can Find More Information, contain
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include, but are not limited to, statements regarding future
product development and related clinical trials and future research and development, including Food
and Drug Administration approval and product sales. Such forward-looking statements involve known
and unknown risks, uncertainties and other factors which may cause the actual results, performance
or achievements of the Company, or industry results, to be materially different from those
expressed or implied by such forward-looking statements. Such factors include, among other things,
the following: our ability to progress any product candidates into pre-clinical or clinical trials;
the scope, rate and progress of our preclinical studies and clinical trials and other research and
development activities; clinical trial results; the cost of filing, prosecuting, defending and
enforcing any patent claims and other intellectual property rights; our ability to obtain rights to
technology; our ability to enter into future collaborations with industry partners and the terms,
timing and success of any such collaboration; the cost, timing and success of regulatory filings
and approvals; our ability to obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity or debt financing or otherwise; general
economic and business conditions; competition; business abilities and judgment of personnel;
availability of qualified personnel; and other factors referenced herein.
You should also consider carefully the statements set forth in the section entitled Risk
Factors and other sections of this prospectus supplement, in the accompanying prospectus, and in
the other documents we have filed with the SEC and that are incorporated herein by reference, which
address these and additional factors that could cause results or events to differ from those set
forth in the forward-looking statements. All subsequent written and oral forward-looking
statements attributable to us or to persons acting on our behalf are expressly qualified in their
entirety by the applicable cautionary statements. We have no plans to update these forward-looking
statements.
S-iii
PROSPECTUS SUPPLEMENT SUMMARY
This summary only highlights the more detailed information appearing elsewhere in this
prospectus supplement, the accompanying prospectus and the documents incorporated by reference
herein and therein. It may not contain all of the information that may be important to you. To
fully understand the investment you are contemplating, you should read carefully this entire
prospectus supplement, the accompanying prospectus and the detailed information incorporated into
each of them by reference before you decide to make an investment. You should pay special
attention to the Risk Factors section of this prospectus supplement beginning on page S-4 to
determine whether an investment in our common stock is appropriate for you. Unless the context
otherwise requires, the terms Novavax, we, us, the company and our refer to Novavax
, Inc., a Delaware corporation, together with its subsidiary.
NOVAVAX, INC.
Novavax, Inc. is a clinical-stage biopharmaceutical company focused on creating
differentiated, value-added vaccines that improve upon current preventive options for a range of
infectious diseases. These vaccines leverage the Companys virus-like particle (VLP) platform
technology coupled with a unique, disposable production technology. In 2005, Novavax transitioned
from a specialty pharmaceutical company that sold and marketed womens health products to an
innovative, biopharmaceutical company focused on vaccines. The Company is now firmly focused on its
VLP vaccine technology platform.
VLPs are genetically engineered three-dimensional nanostructures, which incorporate
immunologically important lipids and recombinant proteins. Our VLPs resemble the virus but lack the
genetic material to replicate the virus. Novavaxs proprietary production technology uses insect
cells rather than chicken eggs or mammalian cells. Our current product targets include vaccines
against the H5N1 and other subtypes of avian influenza with pandemic potential, human seasonal
influenza, influenza A (H1N1) virus, Varicella Zoster, which causes shingles, and Respiratory
Syncytial Virus (RSV).
Novavax made significant progress in 2008 and 2007 in the development of its vaccine that
targets the H5N1 avian influenza with pandemic potential. In June 2007, the Company released
results from an important preclinical study in which ferrets that received Novavaxs pandemic
vaccine were protected from a lethal challenge of the H5N1 virus. After filing an Investigational
New Drug application (IND), Novavax initiated its Phase I/IIa human clinical trial in July 2007.
Novavax released interim human data from the first portion of this clinical trial in December 2007.
These interim results demonstrated that Novavaxs pandemic influenza vaccine can generate a
protective immune response. The Company conducted the second portion of the Phase I/IIa trial in
March 2008 to gather additional subject immunogenicity and safety data and determine a final dose
through the completion of this clinical trial. In August 2008, we reported favorable results from
this clinical trial, which demonstrated strong neutralizing antibody titers across all three doses
tested. Although the safety data are still blinded at the subject level (pending complete safety
follow-up), there were no serious adverse events reported. In February 2009, Novavax announced
that the vaccine induced robust hemagglutination inhibition (HAI) responses, which have been
shown to be important for protection against influenza disease. We only intend to initiate further
human clinical trials for our pandemic influenza vaccine, which would be required for regulatory
approval, with a collaborative partner.
Novavax progressed development of its VLP trivalent vaccine that targets seasonal influenza
virus in 2007 and 2008. In December 2007, Novavax announced results from a preclinical study in
mice. In April 2008, we announced that we received positive results from an immunogenicity study in
ferrets inoculated with our trivalent seasonal influenza vaccine candidate. In September 2008, we
began Phase II
S-1
clinical trials to evaluate the safety and immunogenicity of different doses of our seasonal
influenza vaccine. In November 2008, we announced a delay of our seasonal influenza dose ranging
study in the elderly (>65 years of age) from Q4 2008 to 2009, pending top line safety
and immunogenicity results from our ongoing seasonal influenza study in healthy adults. We had
observed a slightly different safety profile (non-serious adverse events) from our Phase IIa trial
of our pandemic VLP vaccine, and decided to review and analyze the dose response curve as well as
the safety data from the healthy adult seasonal trial prior to commencing a study in the elderly.
In December 2008, we announced favorable safety and immunogenicity results from our Phase IIa
seasonal study in healthy adults. In May 2009, vaccination of healthy adult volunteers in a
further Phase II clinical trial of the seasonal vaccine was completed. The aforementioned seasonal
clinical study in elderly adults is planned for the second half of 2009. We intend to seek a
collaborative partner for our seasonal influenza vaccine upon completion of additional Phase II
clinical studies, which are expected to be completed by the end of 2009.
The Company has also developed vaccine candidates for both RSV and VZV, both of which are
currently being evaluated in preclinical studies. To date, preliminary data have shown that an RSV
vaccine candidate has shown positive results in two separate studies with mice. In December 2008,
Novavax and the University of Massachusetts jointly announced favorable results from a preclinical
study to evaluate the immunogenicity and efficacy of an RSV vaccine candidate in mice. The RSV VLP
vaccine induced strong antibody responses against RSV. The Company has licensed exclusive
worldwide rights from the University of Massachusetts Medical School to certain technology for the
development and commercialization of vaccines. In February 2009, Novavax announced favorable
results from an RSV preclinical study performed in mice against the viral fusion (F) protein, which
fuses with cells in the respiratory tract and causes illness. The vaccine induced neutralizing
antibodies against the viral fusion protein and also protected against RSV infection, reducing the
quantity of RSV virus found in the lungs of immunized mice after a challenge with live virus. A
VZV vaccine candidate has also induced antibody and T-cell responses. The Company is moving
forward with further preclinical development of both vaccines in 2009.
The Company has recently announced that it produced a first batch of the influenza A (H1N1)
VLP vaccine candidate three weeks after the Centers for Disease Control and Prevention (CDC)
announced the genetic sequence of the novel H1N1 virus (the H1N1 virus is commonly referred to as
the swine flu in the media). Novavax has further announced that the Division of Microbiology and
Infectious Diseases (DMID) of the National Insitute of Allergy and Infectious Diseases, National
Institutes of Health have signed an agreement to cooperate in the evaluation of the VLP vaccine
candidate. The purified H1N1 VLP vaccine candidate is being sent to scientists at the CDC and DMID
for studies in animal models.
Importantly, Novavax has developed a unique production process for making its recombinant
VLP-based vaccines using portable, disposable manufacturing technology that has advantages over
traditional egg-based vaccine manufacturing and other vaccines in development. Because the
equipment is both portable and disposable, a facility to produce VLP-based vaccines can be
constructed and validated for production use in 12-18 months (depending on the capacity) as
compared to current egg-based facilities which can take four or more years to deploy. Our
manufacturing technology requires substantially less capital costs than traditional egg-based
manufacturing (currently estimated at up to 75% less capital cost). Due to the use of the Companys
proprietary VLP approach in developing recombinant vaccines, the current production yields up to 10
times the yields of traditional egg-based or mammalian cell culture manufacturing are encouraging
compared to currently used egg-based vaccines as well as developing mammalian cell growth
approaches.
S-2
The following table shows the current stage of each product candidate in Novavaxs vaccine
pipeline:
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Discovery |
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Phase I/IIa |
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Phase IIb/III |
Pandemic Influenza (avian) |
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ü |
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Seasonal Influenza |
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Varicella Zoster (Shingles) |
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Respiratory Syncyntial
Virus (RSV) |
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Influenza A (H1N1) (swine) |
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The Company also had a drug delivery platform based on micellar nanoparticles (MNPs),
proprietary oil and water nanoemulsions used for the topical delivery of drugs. The MNP technology
was the basis for Novavaxs first FDA approved estrogen replacement product,
Estrasorb®. In October 2005, the Company entered into license and supply agreements for
Estrasorb with Allergan, Inc., successor-in-interest to Esprit Pharma, Inc. (Allergan), under
which the Company manufactured Estrasorb, and Allergan had an exclusive license to sell Estrasorb
in North America. In 2007, the Company and Allergan terminated the supply agreement. In April 2006,
the Company entered into a License and Development Agreement and a Supply Agreement with Allergan
to co-develop, supply and commercialize the Companys MNP-based testosterone product candidate for
the treatment of female hypoactive sexual desire disorder. In October 2007, these agreements were
mutually terminated. In February 2008, the Company entered into asset purchase and supply
agreements with Graceway Pharmaceuticals, LLC related to Estrasorb and supply of additional units
of Estrasorb and terminated the Estrasorb license agreement with Allergan. The Company engaged an
investment bank to aid in the search for potential buyers or licensees of technology, but has not
been successful in attempts to sell or license the technology in fields of use outside vaccines.
We may not be successful in our efforts to divest the MNP assets and, if we are, it may not be on
favorable terms. The operations related to our Estrasorb product are shown as discontinued
operations in our financial statements.
CORPORATE INFORMATION
Novavax was incorporated in 1987 under the laws of the State of Delaware. Our principal
executive offices are located at 9920 Belward Campus Drive, Rockville, Maryland, 20850. Our
telephone number is (240) 268-2000 and our website address is www.novavax.com. The contents
of our website are not part of this prospectus supplement or accompanying prospectus.
S-3
THE OFFERING
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Shares of common stock we are offering
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1,094,891 shares |
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Shares of common stock to be outstanding
immediately after this offering
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89,869,062 shares |
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Use of Proceeds
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The net proceeds from this
offering may be used to pay
a portion of our $5 million
outstanding principal
amount of 4.75% senior
convertible notes due July
15, 2009, and other general
corporate purposes as
further described in this
prospectus supplement under
the heading Use of
Proceeds. |
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NASDAQ Global Market symbol
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NVAX |
The number of shares of common stock outstanding after this offering in the table above is
based on 88,774,171 shares of our common stock outstanding as of June 29, 2009 and excludes up to
6,771,669 shares of our common stock issuable upon the exercise of outstanding stock options, up to
3,343,325 shares of our common stock issuable upon the exercise of warrants and up to 1,250,000 shares of common stock issuable upon the conversion of the Notes.
RISK FACTORS
You should carefully consider the following risk factors in evaluating our business. There are
a number of risk factors that could cause our actual results to differ materially from those that
are indicated by forward-looking statements. Some of the risks described relate principally to our
business and the industry in which we operate. Others relate principally to the securities market
and ownership of our common stock. The risks and uncertainties described below are not the only
ones facing us. Additional risks and uncertainties that we are unaware of, or that we currently
deem immaterial, also may become important factors that affect us. Additional risks and
uncertainties that are not yet identified or that we currently deem immaterial may materially harm
our business, operating results and financial condition and could result in a complete loss of your
investment. If any of the following risks occur, our business, financial condition or results of
operations could be materially and adversely affected.
We have a history of losses and our future profitability is uncertain.
Our expenses have exceeded our revenues since our formation in 1987, and our accumulated
deficit at December 31, 2008 was $235.8 million. Our net revenues from continuing operations for
the last three fiscal years were $1.1 million in 2008, $1.5 million in 2007, and $1.7 million in
2006. We have received a limited amount of related revenue from research contracts, licenses and
agreements to provide vaccine candidates, services and technologies. We cannot be certain that we
will be successful in entering into strategic alliances or collaborative arrangements with other
companies that will result in significant revenues to offset our expenses. Our net losses for the
last three fiscal years were $36.0 million in 2008, $34.8 million in 2007 and $23.1 million in
2006, including discontinued operations.
Our historical losses have resulted from research and development expenses for our vaccine and
drug delivery product candidates, sales and marketing expenses, and manufacturing expenses for
Estrasorb, protection of our intellectual property and other general operating expenses. Our losses
increased due to the launch of Estrasorb since 2004 as we expanded our manufacturing capacity, and
sales
S-4
and marketing capabilities. More recently, our losses have increased, and will continue to
increase, as a result of higher research and development efforts to support the development of our
vaccines, particularly our pandemic and seasonal influenza vaccines.
We expect to continue to incur significant operating expenses and anticipate that our expenses
and losses will increase in the foreseeable future as we seek to:
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pay our outstanding $5.0 million principal amount of 4.75% senior convertible notes
due July 15, 2009 (the convertible notes); |
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complete Phase II clinical trials for our seasonal flu vaccine; |
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complete our human Phase I/IIa clinical trial for our pandemic flu vaccines; |
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conduct additional preclinical studies for Varicella Zoster and RSV product
candidates using our VLP vaccine technology platform; |
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obtain validation from the Food and Drug Administration, as a product manufacturing
facility and comply with the FDAs manufacturing facility requirements; and |
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maintain, expand and protect our intellectual property portfolio. |
As a result, we expect our cumulative operating losses to increase until such time, if ever,
that product sales, licensing fees, royalties, milestones, contract research and other sources
generate sufficient revenue to fund our continuing operations. We cannot predict when, if ever, we
might achieve profitability and cannot be certain that we will be able to sustain profitability, if
achieved.
We have limited financial resources and we are not certain that we will be able to maintain
our current level of operations or be to able fund the further development of our product
candidates.
We do not expect to generate revenues from product sales, licensing fees, royalties,
milestones, contract research or other sources in an amount sufficient to fund our operations, and
we will therefore use our cash resources and expect to require additional funds to maintain our
operations, continue our research and development programs, commence future preclinical studies and
clinical trials, seek regulatory approvals and manufacture and market our products. We will seek
such additional funds through public or private equity or debt financings, collaborative licensing
and development arrangements and other sources. We cannot be certain that adequate additional
funding will be available to us on acceptable terms, if at all. If we cannot raise the additional
funds required for our anticipated operations, we may be required to delay significantly, reduce
the scope of or eliminate one or more of our research or development programs, further downsize our
general and administrative infrastructure, or seek alternative measures to avoid insolvency,
including arrangements with collaborative partners or others that may require us to relinquish
rights to certain of our technologies, product candidates or products. If we raise additional
funds through future offerings of shares of our common stock or other securities, such offerings
would cause dilution of your percentage ownership in the Company. Given the current market price
of our common stock, such dilution would likely be substantial. This offering and future offerings
also could have a material and adverse effect on the price of our common stock.
Our convertible notes mature on July 15, 2009 and the use of our cash and common stock to
satisfy this debt could adversely affect our cash flow, dilute stockholders, cause the
price of our common stock to go down and limit our ability to raise capital.
As of April 30, 2009, we had $5.0 million principal amount of our convertible notes
outstanding, although for financial reporting purposes the value was
held at $4.98 million, net of
debt discount, that
S-5
will be accrued to the principal amount over the remaining term of the debt. Under the terms
of the convertible notes, at our option, we can pay up to 50% of the outstanding convertible notes
in Novavax common stock on the due date, subject to the satisfaction of certain conditions,
including, among other things, a requirement that the shares issued upon conversion be registered
or freely tradable without registration, that the shares of common stock have not been suspended
from trading on NASDAQ during the applicable measurement period and there is no threatened
delisting or suspension, and that we are otherwise in compliance with our agreements with the
noteholders. The amount of shares that may be issued at maturity may be subject to adjustment
depending on the noteholders percentage ownership of the Company on an as-converted basis and if
the Companys stock price falls below $2.00 during the measurement period. As a result, the
Company will have to pay a least $2.5 million in cash to satisfy the convertible notes on the due
date unless the notes are converted into common stock, redeemed or amended.
We may incur additional indebtedness in the future for various reasons, including
restructuring the convertible notes, which could extend or increase the risks associated with our
substantial leverage.
The current capital and credit market conditions may adversely affect the companys access
to capital, cost of capital, and ability to execute its business plan as scheduled.
Access to capital markets is critical to our ability to operate. Traditionally,
biopharmaceutical companies have funded their research and development expenditures through raising
capital in the equity markets. Declines and uncertainties in these markets over the past year have
severely restricted raising new capital and have affected companies ability to continue to expand
or fund existing research and development efforts. We require significant capital for research and
development for our product candidates and clinical trials. The general economic and capital
market conditions, both in the United States and worldwide have deteriorated significantly and have
adversely affected our access to capital and increased the cost of capital, and there is no
certainty that a recovery in the capital and credit markets, enabling us to raise capital, will
occur in the 2009 fiscal year. If these economic conditions continue or become worse, the
Companys future cost of equity or debt capital and access to the capital markets could be
adversely affected. In addition, an inability by the Company to access the capital markets on
favorable terms due to our low stock price, or upon our delisting from the NASDAQ Global Market if
we fail to satisfy a listing requirement, could affect our ability to execute our business plan as
scheduled. Moreover, we rely and intend to rely on third-parties, including our clinical research
organizations, third-party manufacturers, and certain other important vendors and consultants. As
a result of the current volatile and unpredictable global economic situation, there may be a
disruption or delay in the performance of our third-party contractors and suppliers. If such
third-parties are unable to adequately satisfy their contractual commitments to us in a timely
manner, our business could be adversely affected.
We are limited in our ability to raise additional capital and any additional sale of common
stock could be significantly dilutive to existing stockholders.
We will need to engage in additional capital raising activities in the near term, even if we
sell all shares offered herein. Current economic and market conditions, as well as our convertible
notes (as described above), significantly restrict our ability to raise capital through common
stock sales and additional indebtedness. Due to these and other conditions, we may not be able to
sell shares of our common stock at a price favorable to us or we may need to sell a large block of
stock to raise sufficient capital or be able to sell any stock at all. The sale of common stock
would cause an immediate and substantial equity dilution for existing stockholders. This may
further depress the market price of our common stock and further impair our ability to raise
additional capital by selling our common stock.
S-6
A portion of our investments are auction rate securities which present potential liquidity
concerns.
As of March 31, 2009, we had $8.1 million invested in auction rate securities, which were
classified as short-term investments available for sale and carried at their estimated fair value
of $6.0 million. Auction rate securities are long-term debt instruments that provide liquidity
through a competitive bidding process known as a Dutch Auction that resets the applicable
interest rates at pre-determined calendar intervals. Due to recent uncertainties in the credit
markets, we may be unable to liquidate some or all of our auction rate securities when we are in
need of the cash to fund operations at prices that are acceptable to us. Even if we are able to
liquidate the investments, the sales may be at a loss. In addition, given the complexity of
auction rate securities and their valuations, our estimates of their fair value may differ from the
actual amount we would be able to collect in the ultimate sale. It is uncertain as to when the
liquidity issues relating to these investments will improve.
We have repositioned ourselves from a specialty pharmaceutical company and face all the
risks inherent in the implementation of a new business strategy.
In 2005, we changed the focus of the Company from the development and commercialization of
specialty pharmaceutical products to the research and development of new products using our
proprietary virus-like particle vaccine technology platform. We cannot predict whether we will be
successful in implementing our new business strategy.
We focus our research and development activities on vaccines, an area in which we have
particular strengths and a technology that appears promising. The outcome of any research and
development program is highly uncertain. Only a small fraction of biotechnology development
programs ultimately result in commercial products or even product candidates and a number of events
could delay our development efforts and negatively impact our ability to obtain regulatory approval
for, and to market and sell, a product candidate. Product candidates that initially appear
promising often fail to yield successful products. In many cases, preclinical or clinical studies
will show that a product candidate is not efficacious or that it raises safety concerns or has
other side effects that outweigh its intended benefit. Success in preclinical or early clinical
trials may not translate into success in large-scale clinical trials. Further, success in clinical
trials will likely lead to increased investment, accelerating cumulative losses, to bring such
products to market. Even after a product is approved and launched, general usage or post-marketing
studies may identify safety or other previously unknown problems with the product, which may result
in regulatory approvals being suspended, limited to narrow indications or revoked, which may
otherwise prevent successful commercialization.
Many of our competitors have significantly greater resources and experience, which may
negatively impact our commercial opportunities and those of our current and future
licensees.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid
and significant technological change. We have many potential competitors, including major drug and
chemical companies, specialized biotechnology firms, academic institutions, government agencies and
private and public research institutions. Many of our competitors have significantly greater
financial and technical resources, experience and expertise in:
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research and development; |
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preclinical testing; |
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designing and implementing clinical trials; |
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regulatory processes and approvals; |
S-7
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production and manufacturing; and |
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sales and marketing of approved products. |
Principal competitive factors in our industry include:
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the quality and breadth of an organizations technology; |
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management of the organization and the execution of the organizations strategy; |
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the skill and experience of an organizations employees and its ability to recruit
and retain skilled and experienced employees; |
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an organizations intellectual property portfolio; |
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the range of capabilities, from target identification and validation to drug
discovery and development to manufacturing and marketing; and |
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the availability of substantial capital resources to fund discovery, development and
commercialization activities. |
Large and established companies such as Merck & Co., Inc., GlaxoSmithKline PLC, Novartis,
Inc., sanofi pasteur, Inc. and MedImmune Inc. (a subsidiary of Astra-Zeneca, Inc.), among others,
compete in the vaccine market. In particular, these companies have greater experience and
expertise in securing government contracts and grants to support their research and development
efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products,
and manufacturing such products on a broad scale and marketing approved products.
There are many seasonal flu vaccines currently approved and marketed. Competition in the sale
of these seasonal flu vaccines is intense. Therefore, newly developed and approved products must
be differentiated from existing vaccines in order to have commercial success. In order to show
differentiation in the seasonal flu space, a product must be more efficacious, particularly in the
elderly population, and/or be less expensive and quicker to manufacture. Many of our competitors
are working on new products and new generations of current products, often by adding an adjuvant
that is used to increase the efficacy of the current product, each of which is intended to be more
efficacious than products currently being marketed. Our seasonal flu product may not prove to be
more efficacious than current products or products under development by our competitors. Further,
our manufacturing system may not provide enough savings of time or money to provide the required
differentiation for commercial success.
Smaller or early-stage companies and research institutions may also prove to be significant
competitors, particularly through collaborative arrangements with large and established
pharmaceutical or other companies. As these companies develop their technologies, they may develop
proprietary positions, which may prevent or limit our product development and commercialization
efforts. We will also face competition from these parties in recruiting and retaining qualified
scientific and management personnel, establishing clinical trial sites and subject registration for
clinical trials, and in acquiring and in-licensing technologies and products complementary to our
programs or potentially advantageous to our business. If any of our competitors succeed in
obtaining approval from the FDA or other regulatory authorities for their products sooner than we
do or for products that are more effective or less costly than ours, our commercial opportunity
could be significantly reduced.
In order to effectively compete, we will have to make substantial investments in development,
testing, manufacturing and sales and marketing or partner with one or more established companies.
There is no assurance that we will be successful in gaining significant market share for any
product or product
S-8
candidate. Our technologies and products also may be rendered obsolete or noncompetitive as a
result of products introduced by our competitors to the marketplace more rapidly and at a lower
cost.
If we lose or are unable to attract key management or other personnel, we may experience delays
in product development.
We depend on our senior executive officers as well as key scientific and other personnel. The
loss of these individuals could harm our business and significantly delay or prevent the
achievement of research, development or business objectives. Our Chief Financial Officer resigned
effective January 28, 2009 to pursue opportunities closer to home. While we have retained an
executive search firm to recruit a replacement Chief Financial Officer, however, we may not be able
to attract a qualified individual on terms acceptable to us. We have not purchased key-man life
insurance on any of our executive officers or key personnel, and therefore may not have adequate
funds to find acceptable replacements for them. Competition for qualified employees is intense
among pharmaceutical and biotechnology companies, and the loss of qualified employees, or an
inability to attract, retain and motivate additional highly skilled employees required for the
expansion of our activities, could hinder our ability to complete human studies successfully and
develop marketable products.
We also rely from time-to-time on outside advisors who assist us in formulating our research
and development and clinical strategy. We may not be able to attract and retain these individuals
on acceptable terms, which could have a material adverse effect on our business, financial
condition and results of operations.
We have experienced significant management turnover.
Our current President and Chief Executive Officer, Rahul Singhvi, assumed this responsibility
in August 2005. Most of our executive officers have joined us since that time. As mentioned
above, our Chief Financial Officer resigned effective January 28, 2009, and efforts are underway to
find a replacement. This lack of management continuity, and the resulting lack of long-term
history with our Company, could result in operational and administrative inefficiencies and added
costs. If we were to experience additional turnover at the executive level, these risks would be
exacerbated.
We may have product liability exposure.
The administration of drugs to humans, whether in clinical trials or after marketing
clearances are obtained, can result in product liability claims. We maintain product liability
insurance coverage in the total amount of $10 million for claims arising from the use of our
currently marketed products and products in clinical trials prior to FDA approval. Coverage is
relatively expensive, and the market pricing can significantly fluctuate. Therefore, we may not be
able to maintain insurance at a reasonable cost. There can be no assurance that we will be able to
maintain our existing insurance coverage or obtain coverage for the use of our other products in
the future. This insurance coverage and our resources may not be sufficient to satisfy all
liabilities resulting from product liability claims. A successful claim may prevent us from
obtaining adequate product liability insurance in the future on commercially desirable items, if at
all. Even if a claim is not successful, defending such a claim would be time-consuming and
expensive, may damage our reputation in the marketplace, and would likely divert managements
attention.
Regardless of merit or eventual outcome, liability claims may result in:
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decreased demand for our products; |
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impairment of our business reputation; |
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withdrawal of clinical trial participants; |
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costs of related litigation; |
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substantial monetary awards to subjects or other claimants; |
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loss of revenues; and |
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the inability to commercialize our product candidates. |
There are outstanding loans owed by certain of our former directors, which if not repaid, would
result in a loss to the Company.
We have two outstanding notes to former directors which are secured by shares of our common
stock. The notes were initially due upon the earlier of (a) the date the individual ceased to be a
director of Novavax, (b) in whole or in part, to the extent of net proceeds on the date on which
the director sold all or a portion of the pledged shares, or (c) March 21, 2007.
In May 2006, one of these directors resigned from the Companys Board of Directors. Following
his resignation, we approved an extension of the former directors $448,000 note to December 31,
2007 or earlier to the extent of the net proceeds of the pledged shares. In connection with this
extension, the former director executed a general release of all claims against the Company. On
May 7, 2008, the Company and the former director entered into an Amended and Restated Promissory
Note and an Amended and Restated Pledge Agreement (the Amendment). The Amendment restates the
entire amount outstanding as of December 31, 2007, including accrued interest, or $578,848, as the
new outstanding principal amount. Furthermore, the Amendment further extends the maturity date of
the note to June 30, 2009, permits us to sell the pledged shares if the market price of the common
stock exceeds certain targets, increases the interest rate to 8.0% and stipulates quarterly
payments beginning on June 30, 2008.
In March 2007, the second director resigned from the Board of Directors before the maturity
date. In an agreement dated May 7, 2007, the Board agreed to extend the note that was due
March 21, 2007 to June 30, 2009 and secured additional collateral in the form of a lien on certain
outstanding stock options. Also under the May 7, 2007 agreement, we have the right to exercise the
stock options, sell the acquired shares and the other shares held as collateral and use the
proceeds to pay the debt, if the share price exceeds a certain target at any time during the period
between May 7, 2007 and June 30, 2009. The note continues to accrue interest at 5.07% per annum
and continues to be secured by 166,666 shares of common stock owned by the former director.
We are uncertain about the collectability of these notes. We do not know if the price of our
common stock will reach the target prices allowing us to realize on the pledged collateral. Even
if we are able to sell some or all of the pledged shares, we may not recover the full amount
outstanding under either note. We continue to actively work with these two individuals to collect
the amounts outstanding and reserve our rights to legal remedies available to us. There are no
assurances that the former directors will be able to repay the notes when due under the terms of
the current agreements.
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We may not be able to win government, institution or non-profit grants.
From time to time, we may apply for grants from academic institutions, government agencies and
non-profit entities. Such grants can be highly attractive because they provide capital to fund the
ongoing development of our technologies and product candidates without diluting our stockholders.
However, there is often significant competition for these grants. Grantors may have requirements
to apply for or to otherwise be eligible to receive certain grants that our competitors may be able
to satisfy that we cannot. In addition, grantors may make arbitrary decisions as to whether to
make grants, to whom the grants will be awarded and the size of the grants to each awardee.
Therefore, we may not be able to win grants.
Current economic conditions and capital markets are in a period of disruption and instability
which could adversely affect our ability to raise capital and may adversely affect our business
and liquidity.
The current economic conditions and related capital markets may have a negative impact on our
ability to access the capital markets, and thus have a negative impact on our business and
liquidity. The shortage of liquidity and credit combined with recent substantial losses in
worldwide equity markets has led to an extended worldwide recession. We may face significant
challenges in selling shares of common stock or in obtaining debt financing if conditions in the
capital markets do not improve.
If we are not able to enter into a collaborative licensing and development arrangement with a
third party or win a government grant, we will need to raise money through additional debt or
equity offerings, even if we sell all of the shares offered herein. Our ability to access the
capital markets may be severely restricted at a time when we are accessing such markets, which
would have a negative impact on our business plans, including our pre-clinical studies and clinical
trial schedules and other research and development activities. Even if we are able to raise
additional capital, it may not be at a price or on terms that are favorable to us and it may cause
a substantial dilution to our existing stockholders. We cannot predict the occurrence of future
disruptions or how long the current conditions may continue.
Raising additional capital by issuing securities or through collaboration and licensing
arrangements may cause dilution to existing stockholders or require us to relinquish rights to
our technologies or product candidates.
If we are unable to partner with a third party to advance the development of one or more of
our vaccine candidates, we will need to raise money through additional debt or equity financings
even if we sell all shares offered herein. To the extent that we raise additional capital by
issuing equity securities, our stockholders will experience immediate and significant
dilution. To the extent that we raise additional capital through licensing arrangements or
arrangements with collaborative partners, we may be required to relinquish, on terms that are not
favorable to us, rights to some of our technologies or product candidates that we would otherwise
seek to develop or commercialize ourselves. In addition, current economic conditions may also
negatively affect the desire or ability of potential collaborators to enter into transactions with
us. They may also have to delay or cancel research and development projects or reduce their
overall budgets.
Global credit and financial market conditions could negatively impact the value of our current
portfolio of cash equivalents or short-term investments and our ability to meet our financing
objectives.
Our short-term investments consist primarily of auction rate securities and are classified as
available for sale. While as of the date of this filing, we have recorded a reduction in the value
of these securities due to their illiquidity of approximately $2.1 million, we cannot assure you
that further
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deterioration in conditions of the global credit and financial markets will not occur. Such a
deterioration could negatively impact our current portfolio of cash equivalents or short-term
investments or our ability to meet our financing objectives. As described above under A portion
of our investments are auction rate securities which present potential liquidity concerns., we
hold some auction rate securities that could have additional liquidity concerns.
PRODUCT DEVELOPMENT RISKS
Because our vaccine product development efforts depend on new and rapidly evolving technologies,
we cannot be certain that our efforts will be successful.
Our vaccine work depends on new, rapidly evolving technologies and on the marketability and
profitability of our products. Commercialization of our vaccine products could fail for a variety
of reasons, and include the possibility that:
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our VLP technology, any or all of the products based on VLP technology or our
proprietary manufacturing process will be ineffective or unsafe, or otherwise fail to
receive necessary regulatory clearances; |
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the products, if safe and effective, will be difficult to manufacture on a large
scale or uneconomical to market; |
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we will fail to have our GMP pilot plant validated or that the plant will fail to
continue to pass regulatory inspections; |
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proprietary rights of third parties will prevent us or our collaborators from
exploiting technologies or marketing products; and |
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third party competitors will gain greater market share due to superior products or
marketing capabilities. |
We have not completed the development of vaccine products and we may not succeed in obtaining
the FDA approval necessary to sell additional products.
The development, manufacture and marketing of our pharmaceutical and biological products are
subject to government regulation in the United States and other countries. In the United States
and most foreign countries, we must complete rigorous preclinical testing and extensive human
clinical trials that demonstrate the safety and efficacy of a product in order to apply for
regulatory approval to market the product. We also have product candidates in human clinical
trials and preclinical laboratory or animal studies.
The steps required by the FDA before our proposed investigational products may be marketed in
the United States include:
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performance of preclinical (animal and laboratory) tests; |
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submissions to the FDA of an IND which must become effective before human clinical
trials may commence; |
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performance of adequate and well-controlled human clinical trials to establish the
safety and efficacy of the investigational product in the intended target population; |
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performance of a consistent and reproducible manufacturing process intended for
commercial use; |
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submission to the FDA of a BLA or a New Drug Application (NDA); and |
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FDA approval of the BLA or NDA before any commercial sale or shipment of the
product. |
The processes are expensive and can take many years to complete, and we may not be able to
demonstrate the safety and efficacy of our products to the satisfaction of such regulatory
authorities. The start of clinical trials can be delayed or take longer than anticipated for many
and varied reasons, many of which are out of our control. Safety concerns may emerge that could
lengthen the ongoing trials or require additional trials to be conducted. Regulatory authorities
may also require additional testing, and we may be required to demonstrate that our proposed
products represent an improved form of treatment over existing therapies, which we may be unable to
do without conducting further clinical studies. Moreover, if the FDA grants regulatory approval of
a product, the approval may be limited to specific indications or limited with respect to its
distribution. Expanded or additional indications for approved drugs may not be approved, which
could limit our revenues. Foreign regulatory authorities may apply similar limitations or may
refuse to grant any approval. Consequently, even if we believe that preclinical and clinical data
are sufficient to support regulatory approval for our product candidates, the FDA and foreign
regulatory authorities may not ultimately grant approval for commercial sale in any jurisdiction.
If our drug candidates are not approved, our ability to generate revenues will be limited and our
business will be adversely affected.
We must identify products and product candidates for development with our VLP technology and
establish successful third-party relationships.
The near and long-term viability of our vaccine product candidates will depend in part on our
ability to successfully establish new strategic collaborations with pharmaceutical and
biotechnology companies and government agencies. Establishing strategic collaborations and
obtaining government funding is difficult and time-consuming. We will only initiate further human
clinical trials for our pandemic influenza vaccine with a collaborative partner and will seek a
collaborative partner for our seasonal influenza vaccine upon completion of additional Phase II
clinical studies. Potential collaborators may reject collaborations based upon their assessment of
our financial, regulatory or intellectual property position; government agencies may reject
contract or grant applications based on their assessment of public need, the public interest, our
products ability to address these areas or other reasons beyond our expectations or control. If
we fail to establish a sufficient number of collaborations or government relationships on
acceptable terms, we may not be able to commercialize our vaccine product candidate or generate
sufficient revenue to fund further research and development efforts.
Even if we establish new collaborations or obtain government funding, these relationships may
never result in the successful development or commercialization of any vaccine product candidates
for several reasons, including the fact that:
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we may not have the ability to control the activities of our partner and cannot
provide assurance that they will fulfill their obligations to us, including with
respect to the license, development and commercialization of products and product
candidates, in a timely manner or at all; |
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such partners may not devote sufficient resources to our products and product
candidates or properly maintain or defend our intellectual property rights; |
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any failure on the part of our partners to perform or satisfy their obligations to
us could lead to delays in the development or commercialization of our products and
product candidates, and affect our ability to realize product revenues; and |
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disagreements, including disputes over the ownership of technology developed with
such collaborators, could result in litigation, which would be time-consuming and
expensive, |
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and may delay or terminate research and development efforts, regulatory approvals,
and commercialization activities. |
Our collaborators will be subject to the same regulatory approval of the manufacturing
facility and process as Novavax. Before we could begin commercial manufacturing of any of our
product candidates, we and our collaborators must pass a pre-approval inspection before FDA
approval and comply with the FDAs current Good Manufacturing Practices. If our collaborators fail
to comply with these requirements, our product candidates would not be approved. If our
collaborators fail to comply with these requirements after approval, we would be subject to
possible regulatory action and may be limited in the jurisdictions in which we are permitted to
sell our products.
If we or our partners fail to maintain our existing agreements or in the event we fail to
establish agreements as necessary, we could be required to undertake research, development,
manufacturing and commercialization activities solely at our own expense. These activities would
significantly increase our capital requirements and, given our lack of sales, marketing and
distribution capabilities, significantly delay the commercialization of products and product
candidates.
Because we depend on third parties to conduct some of our laboratory testing and human studies,
we may encounter delays in or lose some control over our efforts to develop products.
We are dependent on third-party research organizations to conduct some of our laboratory
testing and human studies. If we are unable to obtain any necessary testing services on acceptable
terms, we may not complete our product development efforts in a timely manner. If we rely on third
parties for laboratory testing and human studies, we may lose some control over these activities
and become too dependent upon these parties. These third parties may not complete testing
activities on schedule or when we request. We may not be able to secure and maintain suitable
research organizations to conduct our laboratory testing and human studies. We are responsible for
confirming that each of our clinical trials is conducted in accordance with its general
investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies require us to
comply with regulations and standards, commonly referred to as good clinical practices, for
conducting, recording and reporting the results of clinical trials to assure that data and reported
results are credible and accurate and that the trial participants are adequately protected. Our
reliance on third parties does not relieve us of these responsibilities and requirements. If these
third parties do not successfully carry out their contractual duties or regulatory obligations or
meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of
the data they obtain is compromised due to the failure to adhere to our clinical protocols or
regulatory requirements or for other reasons, our pre-clinical development activities of clinical
trials may be extended, delayed, suspended or terminated, and we may not be able to obtain
regulatory approval for our product candidates.
Our relationship with GE Healthcare may not be profitable.
We have entered into a co-marketing agreement with GE Healthcare to co-market a pandemic
influenza vaccine solution to select international countries. The collaboration incorporates GE
Healthcares bioprocess solutions and design expertise with Novavaxs VLP manufacturing platform.
We cannot predict when, if at all, we will be able to successfully negotiate a definitive agreement
with a target country. Even if we do enter into a definitive agreement, it may not result in
significant revenues.
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Even though we have received governmental support in the past, we may not continue to receive
support at the same level or at all.
The United States government, through its various agencies, has provided grants to fund
certain research and development efforts. There can be no assurances that the Company will
continue to receive the same level of funding from the United States government, if at all.
If we are unable to manufacture our vaccines in sufficient quantities or are unable to obtain
regulatory approvals for a manufacturing facility for our vaccines, we may experience delays in
product development and clinical trials.
Completion of our clinical trials and commercialization of our vaccine product candidates
require access to, or development of, facilities to manufacture a sufficient supply of our product
candidates. We have limited experience manufacturing any of our product candidates in the volumes
that will be necessary to support large-scale clinical trials or commercial sales. Efforts to
establish capabilities may not meet initial expectations as to scheduling, reproducibility, yield,
purity, cost, potency or quality.
If we are unable to manufacture our product candidates in clinical quantities or, when
necessary, in commercial quantities, then we will need to rely on third parties to manufacture
compounds for clinical and commercial purposes. These third-party manufacturers must also receive
FDA approval before they can produce clinical material or commercial products. Our vaccines may be
in competition with other products for access to these facilities and may be subject to delays in
manufacture if third parties give other products greater priority. In addition, we may not be able
to enter into any necessary third-party manufacturing arrangements on acceptable terms, or on a
timely basis. In addition, we would have to enter into a technical transfer agreement and share
our know-how with the third party manufacturer.
We rely on a limited number of suppliers for some of our manufacturing materials. Any problems
experienced by any of these suppliers could negatively affect our operations.
We rely on third-party suppliers and vendors for some of the materials used in the manufacture
of our product candidates. For supply of early clinical trial materials, we rely on a limited
number of suppliers. Any significant problem experienced by one of our suppliers could result in a
delay or interruption in the supply of materials to us until such supplier resolves the problem or
an alternative source of supply is located. We have limited experience with alternative sources of
raw materials. Any delay or interruption could negatively affect our operations.
We have limited marketing capabilities, and if we are unable to enter into collaborations with
marketing partners or develop our own sales and marketing capability, we may not be successful
in commercializing any approved products.
We currently have no sales, marketing or distribution capabilities. As a result, we will
depend on collaborations with third parties that have established distribution systems and sales
forces. To the extent that we enter into co-promotion or other licensing arrangements, our
revenues will depend upon the efforts of third parties, over which we may have little or no
control. If we are unable to reach and maintain agreements with one or more pharmaceutical
companies or collaborators, we may be required to market our products directly. Developing a
marketing and sale force is expensive and time consuming and could delay a product launch. We
cannot be certain that we will be able to attract and retain qualified sales personnel or otherwise
develop this capability.
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Our product candidates may never achieve market acceptance even if we obtain regulatory
approvals.
Even if we receive regulatory approvals for the commercial sale of our product candidates, the
commercial success of these product candidates will depend on, among other things, their acceptance
by physicians, patients, third party payers such as health insurance companies and other members of
the medical community as a therapeutic and cost-effective alternative to competing products and
treatments. If our product candidates fail to gain market acceptance, we may be unable to earn
sufficient revenue to continue our business. Market acceptance of, and demand for, any product
that we may develop and commercialize will depend on many factors, including:
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Our ability to provide acceptable evidence of safety and efficacy; |
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The prevalence and severity of adverse side effects; |
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Availability, relative cost and relative efficacy of alternative and competing
treatments; |
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The effectiveness of our marketing and distribution strategy; |
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Publicity concerning our products or competing products and treatments; and |
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Our ability to obtain sufficient third party insurance coverage or reimbursement. |
If our product candidates do not become widely accepted by physicians, patients, third party
payers and other members of the medical community, our business, financial condition and results of
operations would be materially and adversely affected.
If reforms in the health care industry make reimbursement for our potential products less
likely, the market for our potential products will be reduced, and we could lose potential
sources of revenue.
Our successes may depend, in part, on the extent to which reimbursement for the costs of
therapeutic products and related treatments will be available from third-party payers such as
government health administration authorities, private health insurers, managed care programs, and
other organizations. Over the past decade, the cost of health care has risen significantly, and
there have been numerous proposals by legislators, regulators, and third-party health care payers
to curb these costs. Some of these proposals have involved limitations on the amount of
reimbursement for certain products. Similar federal or state health care legislation may be
adopted in the future and any products that we or our collaborators seek to commercialize may not
be considered cost-effective. Adequate third-party insurance coverage may not be available for us
to establish and maintain price levels that are sufficient for realization of an appropriate return
on our investment in product development. Moreover, the existence or threat of cost control
measures could cause our corporate collaborators to be less willing or able to pursue research and
development programs related to our product candidates.
REGULATORY RISKS
We may fail to obtain regulatory approval for our products on a timely basis or comply with our
continuing regulatory obligations after approval is obtained.
Delays in obtaining regulatory approval can be extremely costly in terms of lost sales
opportunities, losing any potential marketing advantage of being early to market and increased
trial costs.
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The speed with which we begin and complete our preclinical trials necessary to begin human
studies, human clinical trials and our applications for marketing approval will depend on several
factors, including the following:
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our ability to manufacture or obtain sufficient quantities of materials for use in
necessary preclinical studies and clinical trials; |
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prior regulatory agency review and approval; |
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Institutional Review Board approval of the protocol and the informed consent form; |
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the rate of subject or patient enrollment and retention, which is a function of many
factors, including the size of the subject or patient population, the proximity of
subjects and patients to clinical sites, the eligibility criteria for the study and the
nature of the protocol; |
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negative test results or side effects experienced by trial participants; |
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analysis of data obtained from preclinical and clinical activities, which are
susceptible to varying interpretations and which interpretations could delay, limit or
prevent further studies or regulatory approval; |
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the availability of skilled and experienced staff to conduct and monitor clinical
studies and to prepare the appropriate regulatory applications; and |
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changes in the policies of regulatory authorities for drug or vaccine approval
during the period of product development. |
We have limited experience in conducting and managing the preclinical studies and clinical
trials necessary to obtain regulatory marketing approvals. We may not be permitted to continue or
commence additional clinical trials. We also face the risk that the results of our clinical trials
may be inconsistent with the results obtained in preclinical studies or clinical trials of similar
products, or that the results obtained in later phases of clinical trials may be inconsistent with
those obtained in earlier phases. A number of companies in the biopharmaceutical and product
development industry have suffered significant setbacks in advanced clinical trials, even after
experiencing promising results in early animal and human testing.
Regulatory agencies may require us or our collaborators to delay, restrict or discontinue
clinical trials on various grounds, including a finding that the subjects or patients are being
exposed to an unacceptable health risk. In addition, we or our collaborators may be unable to
submit applications to regulatory agencies within the time frame we currently expect. Once
submitted, applications must be approved by various regulatory agencies before we or our
collaborators can commercialize the product described in the application. All statutes and
regulations governing the conduct of clinical trials are subject to change in the future, which
could affect the cost of such clinical trials. Any unanticipated costs or delays in our clinical
studies could delay our ability to generate revenues and harm our financial condition and results
of operations.
Even if regulatory approval is received for our product candidates, the later discovery of
previously unknown problems with a product, manufacturer or facility may result in restrictions,
including withdrawal of the product from the market.
Even if a product gains regulatory approval, such approval is likely to limit the indicated
uses for which it may be marketed, and the product and the manufacturer of the product will be
subject to continuing regulatory review, including adverse event reporting requirements and the
FDAs general prohibition against promoting products for unapproved uses. Failure to comply with
any post-approval
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requirements can, among other things, result in warning letters, product seizures, recalls,
substantial fines, injunctions, suspensions or revocations of marketing licenses, operating
restrictions and criminal prosecutions. Any of these enforcement actions, any unanticipated
changes in existing regulatory requirements or the adoption of new requirements, or any safety
issues that arise with any approved products, could adversely affect our ability to market products
and generate revenues and thus adversely affect our ability to continue our business.
We also may be restricted or prohibited from marketing or manufacturing a product, even after
obtaining product approval, if previously unknown problems with the product or its manufacture are
subsequently discovered and we cannot provide assurance that newly discovered or developed safety
issues will not arise following any regulatory approval. With the use of any drug by a wide
patient population, serious adverse events may occur from time to time that initially do not appear
to relate to the drug itself, and only if the specific event occurs with some regularity over a
period of time does the drug become suspect as having a causal relationship to the adverse event.
Any safety issues could cause us to suspend or cease marketing of our approved products, possibly
subject us to substantial liabilities, and adversely affect our ability to generate revenues and
our financial condition.
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing
our products internationally.
We intend to have our product candidates marketed outside the United States. In order to
market our products in the European Union and many other non-U.S. jurisdictions, we must obtain
separate regulatory approvals and comply with numerous and varying regulatory requirements. To
date, we have not filed for marketing approval for any of our products candidates and may not
receive the approvals necessary to commercialize our product candidates in any market. The
approval procedure varies among countries and can involve additional testing and data review. The
time required to obtain foreign regulatory approval may differ from that required to obtain FDA
approval. The foreign regulatory approval process may include all of the risks associated with
obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at
all. Approval by the FDA does not ensure approval by regulatory agencies in other foreign countries
or by the FDA. However, a failure or delay in obtaining regulatory approval in one jurisdiction
may have a negative effect on the regulatory approval process in other jurisdictions, including
approval by the FDA. The failure to obtain regulatory approval in foreign jurisdictions could harm
our business.
Because we are subject to environmental, health and safety laws, we may be unable to conduct our
business in the most advantageous manner.
We are subject to various laws and regulations relating to safe working conditions, laboratory
and manufacturing practices, the experimental use of animals, emissions and wastewater discharges,
and the use and disposal of hazardous or potentially hazardous substances used in connection with
our research, including infectious disease agents. We also cannot accurately predict the extent of
regulations that might result from any future legislative or administrative action. Any of these
laws or regulations could cause us to incur additional expense or restrict our operations.
Our facility in Maryland is subject to various local, state and federal laws and regulations
relating to safe working conditions, laboratory and manufacturing practices, the experimental use
of animals and the use and disposal of hazardous or potentially hazardous substances, including
chemicals, microorganisms and various hazardous compounds used in connection with our research and
development activities. In the United States, these laws include the Occupational Safety and
Health Act, the Toxic Test Substances Control Act and the Resource Conservation and Recovery Act.
We cannot eliminate the risk of accidental contamination or discharge or injury from these
materials. Federal, state, and local laws and
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regulations govern the use, manufacture, storage, handling and disposal of these materials.
We could be subject to civil damages in the event of an improper or unauthorized release of, or
exposure of individuals to, these hazardous materials. In addition, claimants may sue us for
injury or contamination that results from our use or the use by third parties of these materials,
and our liability may exceed our total assets. Compliance with environmental laws and regulations
may be expensive, and current or future environmental regulations may impair our research,
development or production efforts.
Although we have general liability insurance, these policies contain exclusions from insurance
against claims arising from pollution from chemical or pollution from conditions arising from our
operations. Our collaborators are working with these types of hazardous materials in connection
with our collaborations. In the event of a lawsuit or investigation, we could be held responsible
for any injury we or our collaborators cause to persons or property by exposure to, or release of,
any hazardous materials. However, we believe that we are currently in compliance with all
applicable environmental and occupational health and safety regulations.
INTELLECTUAL PROPERTY RISKS
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success in large part depends on our ability to maintain the proprietary nature of our
technology and other trade secrets, including our proprietary drug delivery and biological
technologies. To do so, we must prosecute and maintain existing patents, obtain new patents and
pursue trade secret and other intellectual property protection. We also must operate without
infringing the proprietary rights of third parties or allowing third parties infringe our rights.
We currently have or have rights to over 99 United States patents and corresponding foreign patents
and patent applications covering our technologies. However, patent issues relating to
pharmaceuticals and biologics involve complex legal, scientific and factual questions. To date, no
consistent policy has emerged regarding the breadth of biotechnology patent claims that are granted
by the United States Patent and Trademark Office or enforced by the federal courts. Therefore, we
do not know whether our patent applications will result in the issuance of patents, or that any
patents issued to us will provide us with any competitive advantage. We also cannot be sure that
we will develop additional proprietary products that are patentable. Furthermore, there is a risk
that others will independently develop or duplicate similar technology or products or circumvent
the patents issued to us.
There is a risk that third parties may challenge our existing patents or claim that we are
infringing their patents or proprietary rights. We could incur substantial costs in defending
patent infringement suits or in filing suits against others to have their patents declared invalid
or claim infringement. It is also possible that we may be required to obtain licenses from third
parties to avoid infringing third-party patents or other proprietary rights. We cannot be sure
that such third-party licenses would be available to us on acceptable terms, if at all. If we are
unable to obtain required third-party licenses, we may be delayed in or prohibited from developing,
manufacturing or selling products requiring such licenses.
Although our patents include claims covering various features of our products and product
candidates, including composition, methods of manufacture and use, our patents do not provide us
with complete protection against the development of competing products. Some of our know-how and
technology is not patentable. To protect our proprietary rights in unpatentable intellectual
property and trade secrets, we require employees, consultants, advisors and collaborators to enter
into confidentiality agreements. These agreements may not provide meaningful protection for our
trade secrets, know-how or other proprietary information.
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If we infringe or are alleged to infringe the intellectual property rights of third parties, it
will adversely affect our business, financial condition and results of operations.
Our research, development and commercialization activities, including any product candidates
or products resulting from these activities, may infringe or be claimed to infringe patents owned
by third parties and to which we do not hold licenses or other rights. There may be rights we are
not aware of, including applications that have been filed but not published that, when issued,
could be asserted against us. These third parties could bring claims against us, and that would
cause us to incur substantial expenses and, if successful against us, could cause us to pay
substantial damages. Further, if a patent infringement suit were brought against us, we could be
forced to stop or delay research, development, manufacturing or sales of the product or biologic
drug candidate that is the subject of the suit.
As a result of patent infringement claims, or in order to avoid potential claims, we may
choose or be required to seek a license from the third party. These licenses may not be available
on acceptable terms, or at all. Even if we are able to obtain a license, the license would likely
obligate us to pay license fees or royalties or both, and the rights granted to us might be
nonexclusive, which could result in our competitors gaining access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product, or be forced to cease
some aspect of our business operations, if, as a result of actual or threatened patent infringement
claims, we are unable to enter into licenses on acceptable terms. All of the issues described
above could also impact our collaborators, which would also impact the success of the collaboration
and therefore us.
There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries. In addition to
infringement claims against us, we may become a party to other patent litigation and other
proceedings, including interference proceedings declared by the United States Patent and Trademark
Office and opposition proceedings in the European Patent Office, regarding intellectual property
rights with respect to our products and technology.
We may become involved in lawsuits to protect or enforce our patents or the patents of our
collaborators or licensors, which could be expensive and time consuming.
Competitors may infringe our patents or the patents of our collaborators or licensors. As a
result, we may be required to file infringement claims to counter infringement for unauthorized
use. This can be expensive, particularly for a company of our size, and time-consuming. In
addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or
is unenforceable, or may refuse to stop the other party from using the technology at issue on the
grounds that our patents do not cover its technology. An adverse determination of any litigation
or defense proceedings could put one or more of our patents at risk of being invalidated or
interpreted narrowly and could put our patent applications at the risk of not issuing.
Interference proceedings brought by the United States Patent and Trademark Office may be
necessary to determine the priority of inventions with respect to our patent applications or those
of our collaborators or licensors. Litigation or interference proceedings may fail and, even if
successful, may result in substantial costs and distraction to our management. We may not be able,
alone or with our collaborators and licensors, to prevent misappropriation of our proprietary
rights, particularly in countries where the laws may not protect such rights as fully as in the
United States.
Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. In addition, during the course of
this kind of
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litigation, there could be public announcements of the results of hearings, motions or other
interim proceedings or developments. If investors perceive these results to be negative, the
market price for our common stock could be significantly harmed.
We may need to license intellectual property from third parties and if our right to use the
intellectual property we license is affected, our ability to develop and commercialize our
product candidates may be harmed.
We expect that we will need to license intellectual property from third parties in the future
and that these licenses will be material to our business. We will not own the patents or patent
applications that underlie these licenses, and we will not control the enforcement of the patents.
We will rely upon our licensors to properly prosecute and file those patent applications and
prevent infringement of those patents.
Our license agreement with Wyeth Holdings Corporation, which gives us rights to a family of
patent applications covering VLP technology for use in human vaccines in certain fields of use, is
non-exclusive. These applications are very significant to our business. Payments since inception,
under this agreement, have aggregated $4.8 million as of March 30, 2009 and are expected to
aggregate an additional $0.3 million during 2009, based on current planned clinical development and
therefore, related milestones achieved under the agreement. If each milestone is achieved for any
particular product candidate, we would be obligated to pay an aggregate of $14 million to Wyeth
Holdings for each product candidate developed and commercialized under the agreement. Achievement
of each milestone is subject to many risks, including those described in these Risk Factors.
Annual license maintenance fees under the Wyeth Holdings agreement aggregate $0.3 million per year.
Our license with the University of Massachusetts gives us exclusive rights to develop and
commercialize vaccines incorporating certain virus-like particles for use in human vaccines.
While many of the licenses under which we have rights provide us with rights in specified
fields, the scope of our rights under these and other licenses may be subject to dispute by our
licensors or third parties. In addition, our rights to use these technologies and practice the
inventions claimed in the licensed patents and patent applications are subject to our licensors
abiding by the terms of those licenses and not terminating them. Any of our licenses may be
terminated by the licensor if we are in breach of a term or condition of the license agreement, or
in certain other circumstances.
Our product candidates and potential product candidates will require several components that
may each be the subject of a license agreement. The cumulative license fees and royalties for
these components may make the commercialization of these product candidates uneconomical.
If patent laws or the interpretation of patent laws change, our competitors may be able to
develop and commercialize our discoveries.
Important legal issues remain to be resolved as to the extent and scope of available patent
protection for biotechnology products and processes in the United States and other important
markets outside the United States, such as Europe and Japan. Foreign markets may not provide the
same level of patent protection as provided under the United States patent system. We expect that
litigation or administrative proceedings will likely be necessary to determine the validity and
scope of certain of our and others proprietary rights. Any such litigation or proceeding may
result in a significant commitment of resources in the future and could force us to do one or more
of the following: cease selling or using any of our products that incorporate the challenged
intellectual property, which would adversely affect our revenue; obtain a license from the holder
of the intellectual property right alleged to have been infringed, which license may not be
available on reasonable terms, if at all; and redesign our products to avoid
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infringing the intellectual property rights of third parties, which may be time-consuming or
impossible to do. In addition, changes in, or different interpretations of, patent laws in the
United States and other countries may result in patent laws that allow others to use our
discoveries or develop and commercialize our products. We cannot provide assurance that the
patents we obtain or the unpatented technology we hold will afford us significant commercial
protection.
RISKS RELATED TO OUR COMMON STOCK AND ORGANIZATIONAL STRUCTURE
Because our stock price has been and will likely continue to be volatile, the market price of
our common stock may be lower or more volatile than expected.
Our stock price has been highly volatile. The stock market in general and the market for
biotechnology companies in particular have experienced extreme volatility that has often been
unrelated to the operating performance of particular companies. From January 1, 2008 through March
30, 2009, the closing price of our common stock has been as low as $0.56 per share and as high as
$3.53 per share. The market price of our common stock may be influenced by many factors,
including:
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future announcements about our Company or our collaborators or competitors,
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clinical trial results; |
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depletion of our cash reserves; |
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the approach of the maturity of our convertible notes on July 15, 2009 if additional
capital is not raised, or the payment and/or conversion of our convertible notes; |
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sale of equity securities or issuance of additional debt; |
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announcement by us of significant strategic partnerships, collaborations, joint
ventures, capital commitments or acquisitions; |
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changes in government regulations; |
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developments in our relationships with our collaboration partners; |
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announcements relating to health care reform and reimbursement levels for new drugs; |
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sales of substantial amounts of our stock by existing stockholders (including stock
by insiders or 5% stockholders); |
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litigation; |
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public concern as to the safety of our products; |
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significant set-backs or concerns with the industry or the market as a whole; and |
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the other factors described in this Risk Factors section. |
The stock market has experienced extreme price and volume fluctuation that have particularly
affected the market price for many emerging and biotechnology companies. These fluctuations have
often been unrelated to the operating performance of these companies. These broad market
fluctuations may cause the market price of our common stock to be lower or more volatile than
expected.
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We have never paid dividends on our capital stock, and we do not anticipate paying any such
dividends in the foreseeable future.
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future. As a result, capital appreciation, if any, of our
common stock would be the only source of gain for stockholders until dividends are paid, if at all.
Provisions of our Certificate of Incorporation and By-laws, Delaware law, and our Shareholder
Rights Plan could delay or prevent the acquisition of the Company, even if such acquisition
would be beneficial to stockholders, and could impede changes in our Board.
Our organizational documents could hamper a third partys attempt to acquire, or discourage a
third party from attempting to acquire control of, the Company. We have also adopted a shareholder
rights plan, or poison pill, that empowers our Board to delay or negotiate, and thereby possibly
thwart, any tender offer or takeover attempt the Board opposes. Stockholders who wish to
participate in these transactions may not have the opportunity to do so. These provisions also
could limit the price investors are willing to pay in the future for our securities and make it
more difficult to change the composition of our Board in any one year. These provisions include
the right of the Board to issue preferred stock with rights senior to those of common stock without
any further vote or action by stockholders, the existence of a staggered Board with three classes
of directors serving staggered three-year terms and advance notice requirements for stockholders to
nominate directors and make proposals.
The Company also is afforded the protections of Section 203 of the Delaware General
Corporation Law, which will prevent us from engaging in a business combination with a person who
acquires at least 15% of our common stock for a period of three years from the date such person
acquired such common stock, unless advance board or stock holder approval was obtained.
Any delay or prevention of a change of control transaction or changes in our Board of Director
or management could deter potential acquirers or prevent the completion of a transaction in which
our stockholders could receive a substantial premium over the then current market price for their
shares.
USE OF PROCEEDS
We estimate that the net proceeds to us from the sale of our common stock and in this offering
will be approximately $2.98 million after paying transaction expenses.
We may use the net proceeds from this offering to pay a portion of our $5 million outstanding
principal amount of 4.75% senior convertible notes due July 15, 2009 (the convertible notes). In
addition, we may use a portion of the net proceeds we receive from this offering for a variety of
other corporate uses, including internal research and development programs, working capital,
capital expenditures and other general corporate purposes.
While we expect that the majority of the net proceeds may be allocated to the repayment of the
convertible notes, at this time, we have not determined the exact amount of net proceeds that will
be allocated to each of the uses of proceeds stated above. Our management will retain broad
discretion as to the allocation of the net proceeds from this offering. Pending application of the
net proceeds as described above, we intend to invest the proceeds in highly liquid,
investment-grade securities and money market funds.
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DILUTION
If you invest in our common stock, your interest will be diluted to the extent of the
difference between the public offering price per share you pay in this offering and the net
tangible book value per share of our common stock immediately after this offering. Our net
tangible book value of our common stock as of March 31, 2009 was approximately $4.7 million, or
approximately $0.07 per share of common stock based upon 68,855,091 shares outstanding. Net
tangible book value per share is equal to our total tangible assets, less our total liabilities,
divided by the total number of shares of our common stock outstanding as of March 31, 2009. After
giving effect to the sale by us of the 1,094,891 shares of our common stock we are offering, our
as-adjusted net tangible book value would have been approximately $7.7 million, or approximately
$0.11 per share of common stock based upon 69,949,982 shares outstanding. This represents an
immediate increase in net tangible book value of $0.04 per share to our existing stockholders and
an immediate dilution in net tangible book value of $2.63 per share to new investors. The
following table illustrates this calculation on a per share basis:
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Offering price per share |
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2.74 |
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Net tangible book value per share as of March 31, 2009 |
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0.07 |
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Increase in net tangible book value per share attributable to the offering |
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0.04 |
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As-adjusted net tangible book value per share after giving effect to the offering |
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$ |
0.11 |
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Dilution in net tangible book value per share to new investors |
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$ |
2.63 |
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The foregoing table excludes the following, each stated as of March 31, 2009:
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4,088,912 shares of our common stock issuable upon the exercise of exercisable stock
options at a weighted average exercise price of $3.48 per share; |
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2,682,757 shares of our common stock issuable upon the exercise of outstanding stock
options that are not exercisable; |
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5,500,000 shares of our common stock issuable upon the conversion of our 4.75%
senior convertible notes; |
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3,343,325 shares of our common stock issuable upon the exercise of warrants at an
exercise price of $3.62 per share; and |
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2,447,737 shares of common stock reserved for future issuance under our stock plans. |
In addition to
the foregoing, the table above also excludes the issuance of shares
of our common stock subsequent to March 31, 2009 as follows: (i) 12,500,000 shares to Satellite
Overseas (Holdings) Limited, (ii) 2,040,000 shares upon conversion of approximately $17,000,000 of our
4.75% senior convertible notes and (iii) 5,379,077 shares resulting from sales pursuant to our At the
Market Sales Agreement with Wm Smith & Co. After giving effect to the offering and the aggregate
number of shares issued subsequent to March 31, 2009 as set forth above, the as-adjusted net tangible
book value per share is $0.55 and the dilution in net tangible book value per share is $2.19.
PLAN OF DISTRIBUTION
We have entered or will enter into a stock purchase agreement directly with the investor in
connection with this offering. Assuming the stock purchase agreement is executed by the investor
as currently contemplated and subject to the terms and conditions of the stock purchase agreement,
the investor has agreed or will agree to purchase, and we have agreed or will agree to sell,
1,094,891 shares of our common stock, as provided on the cover of this prospectus supplement.
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The shares of common stock sold in this offering will be listed on the NASDAQ Global Market.
We expect that the shares of common stock will be delivered only in book-entry form through The
Depository Trust Company, New York, New York on or about July 1, 2009.
The expenses directly related to this offering are estimated to be approximately $25,000 and
will be paid by us. Expenses of the offering include our legal and accounting fees, printing
expenses, transfer agent fees, NASDAQ Global Market listing fees and miscellaneous fees.
We are selling 1,094,891 shares of our common stock under this prospectus supplement directly
to a single investor.
We currently anticipate that the closing of the sale of our common stock under this prospectus
supplement will take place on or about July 1, 2009 and we will receive funds in the amount of the
aggregate purchase price. On July 1, 2009, we will issue the shares of common stock to the
investor.
The transfer agent for our common stock is ComputerShare. Our common stock is traded on The
NASDAQ Global Market under the symbol NVAX.
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LEGAL MATTERS
Certain legal matters with respect to the securities offered hereby have been passed upon by
Ballard Spahr Andrews & Ingersoll, LLP.
EXPERTS
Grant Thornton LLP, independent registered public accounting firm, has audited our
consolidated financial statements included in our Annual Report on Form 10-K for the year ended
December 31, 2008, and the effectiveness of our internal control over financial reporting as of
December 31, 2008, as set forth in their reports, which are incorporated by reference in this
prospectus supplement and the accompanying prospectus. Our financial statements and our
managements assessment of the effectiveness of internal control over financial reporting as of
December 31, 2008 are incorporated by reference in reliance upon the reports of Grant Thornton LLP,
upon the authority of said firm as experts in accounting and auditing in giving said reports.
LIMITATION OF LIABILITY AND INDEMNIFICATION
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to our directors, officers and controlling persons pursuant to the foregoing provisions, or
otherwise, we have been advised that, in the SECs opinion, such indemnification is against public
policy as expressed in the Securities Act and is, therefore, unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We are a public company and file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file at the SECs public
reference room at 100 F Street, NE, Washington, D.C. 20549. You can request copies of these
documents by writing to the SEC and paying a fee for the copying cost. Please call the SEC at
1-800-SEC-0330 for more information about the operation of the public reference room. Our SEC
filings are also available to the public at the SECs website at http://www.sec.gov. Our website
address is www.novavax.com. However, information on our website will not be considered a part of
this prospectus supplement or the accompanying prospectus.
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INCORPORATION BY REFERENCE
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 those documents. The
information incorporated by reference is considered to be part of this prospectus supplement and
the accompanying prospectus and the information we file later with the SEC prior to the completion
of this offering will automatically update and supersede this information.
We incorporate by reference the documents listed below and any future filings made with the
SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934 until this
offering is completed, provided however that we are not incorporating by reference any documents or
information deemed to have been furnished and not filed in accordance with SEC rules. The
documents that we are incorporating by reference are:
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Annual Report on Form 10-K for the year ended December 31, 2008; |
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Quarterly Report on Form 10-Q for the quarter ended March 31, 2009; |
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Definitive Proxy Statement with respect to the Annual Meeting of Stockholders to be
held on May 13, 2009, as filed with the SEC on April 16, 2009; and |
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Current Reports on Form 8-K filed on January 5, 2009, January 13, 2009, January 15,
2009, February 9, 2009, February 20, 2009, March 31, 2009 (Item 1.01 only), April 2,
2009, April 29, 2009, May 22, 2009 and June 26, 2009; and |
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The description of our common stock contained in the Registration Statement on Form
10 filed with the SEC on September 14, 1995. |
You may request a copy of these filings at no cost by writing or telephoning Investor
Relations at the following address and telephone number:
Novavax, Inc.
9920 Belward Campus Drive
Rockville, MD 20850
(240) 268-2000
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PROSPECTUS
$100,000,000
Common Stock
Preferred Stock
Warrants
We may issue and sell from time to time our common stock, preferred stock, warrants
and/or units consisting of two or more of any such securities on terms to be determined at the time
of sale. The preferred stock may be convertible into shares of our common stock and the warrants
may be exercisable for shares of our common stock or shares of our preferred stock. We may offer
these securities separately or together in one or more offerings with a maximum aggregate offering
price of $100,000,000.
We will provide a prospectus supplement each time we issue securities, specifying the specific
terms of the securities being sold as well as the specific terms of that offering.
You should read this prospectus and any prospectus supplement, including any information
incorporated herein and therein, carefully before you invest.
The securities being sold may be sold on a delayed or continuous basis directly by us, through
dealers, agents or underwriters designated from time to time, or through any combination of these
methods. If any dealers, agents or underwriters are involved in the sale of the securities in
respect of which this prospectus is being delivered, we will disclose their names and the nature of
our arrangements with them in any prospectus supplement. The net proceeds we expect to receive
from any such sale will also be included in the applicable prospectus supplement.
Our common stock is traded on the NASDAQ Global Market under the symbol NVAX. On November 20,
2006, the closing price of our common stock as reported on the NASDAQ Global Market was $5.28 per
share. None of the other securities offered under this prospectus are publicly traded.
Investing in our securities involves a high degree of risk. See RISK FACTORS beginning on page 4.
This prospectus may not be used to offer or sell securities unless accompanied by a prospectus
supplement for the securities being sold.
Neither the Securities and Exchange Commission nor any other regulatory body has approved or
disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any
representation to the contrary is a criminal offense.
The date of this Prospectus is December 11, 2006.
TABLE OF CONTENTS
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Novavax, Inc. |
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Risk Factors |
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About this Prospectus |
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Special Note Regarding Forward-Looking Statements |
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Use of Proceeds |
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Plan of Distribution |
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Description of Our Capital Stock |
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Description of Our Warrants |
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Description of Our Units |
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Dividend Policy |
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Legal Matters |
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Experts |
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Where You Can Find More Information |
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Incorporation of Certain Information by Reference |
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You should rely only on the information contained in this prospectus and in any prospectus
supplement (including in any documents incorporated by reference herein or therein). We have not
authorized anyone to provide you with any different information. We are offering to sell our
securities, and seeking offers to buy, only in jurisdictions where offers and sales are permitted.
The information contained in this prospectus and any prospectus supplement is accurate only as of
the date of this prospectus or such prospectus supplement, and the information contained in any
document incorporated herein or therein by reference is accurate only as of the date of such
document incorporated by reference, regardless of the time of delivery or any sale of our
securities.
In this prospectus, we, us, our and the company refer to Novavax, Inc., together with
its subsidiary, unless the context otherwise requires.
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NOVAVAX, INC.
Novavax, Inc., a Delaware corporation, was incorporated in 1987, and is a biopharmaceutical
company focused on creating differentiated, value-added vaccines that leverage the companys
proprietary virus-like particle (VLP) technology utilizing the baculovirus expression system in
insect cells, as well as developing novel vaccine adjuvants based on Novasomes®. VLPs
imitate the three-dimensional structures of viruses but are composed of recombinant proteins and,
therefore, are believed incapable of causing infection and disease. Our proprietary production
technology uses insect cells rather than chicken eggs or mammalian cells. We believe that this
allows the company to more rapidly produce safe, effective, low-cost and therapeutic proteins. We
are developing vaccines against the H5N1, H9N2 and other subtypes of avian influenza with pandemic
potential and against human seasonal influenza as well as other viral diseases.
We have also developed a drug delivery platform using micellar nanoparticle (MNP)
technology, proprietary oil and water nanoemulsions used for the tropical delivery of drugs, which
was the basis for the development of its first Food and Drug Administration-approved product,
ESTRASORB®, which is a topical emulsion for estrogen therapy. In October 2005, we
entered into a License Agreement and a Supply Agreement for ESTRASORB with Esprit Pharma, Inc.
(Esprit). Under the agreements, we will continue to manufacture ESTRASORB and the licensee,
Esprit, was granted an exclusive license to sell ESTRASORB in North America. In April 2006, we
entered into a License and Development Agreement and a Supply Agreement with Esprit to co-develop,
supply and commercialize our MNP testosterone product candidate for the treatment of female
hypoactive sexual desire disorder. Esprit was granted exclusive rights to market the product in
North America.
Our strategy is to develop new product candidates based on our drug delivery technologies and
to co-promote or license such products. We intend to use the cash generated by such arrangements
primarily to fund our avian and seasonal flu vaccine programs, which we believe are our long-term
growth drivers.
Our principal executive offices are located at 508 Lapp Road, Malvern, Pennsylvania 19355. Our
telephone number is (484) 913-1200 and our Internet address is www.novavax.com.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider
the following risk factors and all other information contained in this prospectus and any
accompanying prospectus supplement as well as other information we incorporate by reference in this
prospectus and any accompanying prospectus supplement. The risks and uncertainties described below
are not the only ones facing us. Additional risks and uncertainties that we are unaware of, or that
we currently deem immaterial, also may become important factors that affect us. If any of the
following risks occur, our business, financial condition or results of operations could be
materially and adversely affected. In that case, the value of our securities could decline, and you
may lose some or all of your investment.
RISKS RELATED TO OUR BUSINESS
We have repositioned ourselves from a specialty biopharmaceutical company to a biopharmaceutical
company and face all the risks inherent in the implementation of a new business strategy.
In conjunction with the sale of our prenatal and related product lines and the grant of an
exclusive North American license to our lead product ESTRASORB during the second half of 2005, we have changed the focus of the
company from the development and commercialization of specialty pharmaceutical products to the
research and development of new products using our proprietary drug delivery and biological
platforms. We cannot predict whether we will be successful in implementing our new business
strategy.
We intend to focus our research and development activities on areas in which we have
particular strengths and on technologies that appear promising. These technologies often are on
the cutting edge of modern science. As a result, the outcome of any research or development
program is highly uncertain. Only a very small fraction of these programs ultimately result in
commercial products or even product candidates and a number of events could delay our development
efforts and negatively impact our ability to obtain regulatory approval for, and to market and
sell, a product candidate. Product candidates that initially appear promising often fail to yield
successful products. In many cases, preclinical or clinical studies will show that a product
candidate is not efficacious or that it raises safety concerns or has other side effects that
outweigh the intended benefit. Success in preclinical or early clinical trials may not translate
into success in large-scale clinical trials. Further, success in clinical trials will likely lead
to increased investment, adversely affecting short-term profitability, to bring such products to
market. Even after a product is approved and launched, general usage or post-marketing studies may
identify safety or other previously unknown problems with the product, which may result in
regulatory approvals being suspended, limited to narrow indications or revoked, or which may
otherwise prevent successful commercialization.
We must identify products and product candidates for development with our technologies and
establish successful government and third-party relationships.
Our long-term ability to generate product-related revenue depends in part on our ability to
identify products and product candidates that may utilize our drug delivery and biological
technologies. If internal efforts do not generate sufficient product candidates, we will need to
identify third parties that wish to license our technologies for development of their products or
product candidates. We may be unable to license our technologies to third parties for a number of
reasons, including:
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an inability to negotiate license terms that would allow us to make an appropriate
return from resulting products; |
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an inability to identify suitable products or product candidates within, or
complementary to, our areas of expertise; or |
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an unwillingness on the part of competitors to utilize the technologies of a competing
company or disclose the existence or status of new products or products candidates under
development. |
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Our near and long-term viability will also depend in part on our ability to successfully
establish new strategic collaborations with pharmaceutical and biotechnology companies and
government agencies. Establishing strategic collaborations and obtaining government funding are
difficult and time-consuming. Potential collaborators may reject collaborations based upon their
assessment of our financial, regulatory or intellectual property position; government agencies may
reject contract or grant applications based on their assessment of public need, the public interest
and our products ability to address these areas. If we fail to establish a sufficient number of
collaborations or government relationships on acceptable terms, we may not generate sufficient
revenue.
Even if we successfully establish new collaborations or obtain government funding, these
relationships may never result in the successful development or commercialization of any product
candidates or the generation of any sales or royalty revenue. Reliance on such relationships also
exposes us to a number of risks. We may not have the ability to control the activities of our
partners and cannot assure you that they will fulfill their obligations to us, including with
respect to the license, development and commercialization of products and product candidates, in a
timely manner or at all. We cannot assure you that such partners will devote sufficient resources
to our products and product candidates or properly maintain or defend our intellectual property
rights; we also can give no assurances that our partners will not utilize such rights in such a way
as to invite or cause litigation. Any failure on the part of our partners to perform or satisfy
their obligations to us could lead to delays in the development or commercialization of products
and product candidates, and affect our ability to realize product revenues. Disagreements,
including disputes over the ownership of technology developed with such collaborators, could result
in litigation, which would be time-consuming and expensive, and may delay or terminate research and
development efforts, regulatory approvals, and commercialization activities. If we or our partners
fail to maintain our existing agreements or in the event we fail to establish agreements as
necessary, we could be required to undertake research, development, manufacturing and
commercialization activities solely at our own expense. These activities would significantly
increase our capital requirements and, given our current limited sales, marketing and distribution
capabilities, significantly delay the commercialization of products and product candidates.
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success in large part depends on our ability to maintain the proprietary nature of our
technology and other trade secrets, including our proprietary drug delivery and biological
technologies. To do so, we must prosecute and maintain existing patents, obtain new patents and
pursue trade secret and other intellectual property protection. We also must operate without
infringing the proprietary rights of third parties or letting third parties infringe our rights. We
currently have over fifty U.S. patents and corresponding foreign patents and patent applications
covering our technologies. However, patent issues relating to pharmaceuticals involve complex
legal, scientific and factual questions. To date, no consistent policy has emerged regarding the
breadth of biotechnology patent claims that are granted by the U.S. Patent and Trademark Office or
enforced by the federal courts. Therefore, we do not know whether our patent applications will
result in the issuance of patents, or that any patents issued to us will provide us with any
competitive advantage. We also cannot be sure that we will develop additional proprietary products
that are patentable. Furthermore, there is a risk that others will independently develop or
duplicate similar technology or products or circumvent the patents issued to us.
There is a risk that third parties may challenge our existing patents or claim that we are
infringing their patents or proprietary rights. We could incur substantial costs in defending
patent infringement suits or in filing suits against others to have their patents declared invalid
or claim infringement. It is also possible that we may be required to obtain licenses from third
parties to avoid infringing third-party patents or other proprietary rights. We cannot be sure that
such third-party licenses would be available to us on acceptable terms, if at all. If we are unable
to obtain required third-party licenses, we may be delayed in or prohibited from developing,
manufacturing or selling products requiring such licenses.
Although our patents include claims covering various features of our products and product
candidates, including composition, methods of manufacture and use, our patents do not provide us
with complete protection against the development of competing products. Some of our know-how and
technology is not patentable. To protect our proprietary rights in unpatentable intellectual
property and trade secrets, we require employees, consultants, advisors and collaborators to enter
into confidentiality agreements. These agreements may not provide meaningful protection for our
trade secrets, know-how or other proprietary information in the event of any unauthorized use or
disclosure.
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We have limited financial resources and we are not certain that we will be able to obtain financing
to maintain our operations or to fund the development of future products.
Over the next few years we may not generate revenues from product sales, licensing fees,
royalties, milestones, contract research and other sources in an amount sufficient to fund our
operations, and we will therefore use our cash resources and could require additional funds to
maintain our operations, continue our research and development programs, commence future
preclinical and clinical trials, seek regulatory approvals and market our products. We will seek
such additional funds through public or private equity or debt financings, collaborative
arrangements and other sources. We cannot be certain that adequate additional funding will be
available to us on acceptable terms, if at all. If we cannot raise the additional funds required
for our anticipated operations, we may be required to delay significantly, reduce the scope of or
eliminate one or more of our research or development programs, downsize our general and
administrative infrastructure or programs, or seek alternative measures to avoid insolvency,
including arrangements with collaborative partners or others that may require us to relinquish
rights to certain of our technologies, product candidates or products. If we raise additional funds
through future offerings of shares of our common stock or other securities, such offerings would
cause dilution of existing stockholders percentage ownership in the company. These future
offerings also could have a material and adverse effect on the price of our common stock.
We have a history of losses and our future profitability is uncertain.
Our expenses have exceeded our revenues since our formation in 1987, and our accumulated
deficit at September 30, 2006 was $158.8 million. Our net revenues for the last three fiscal years
were $7.4 million in 2005, $8.3 million in 2004 and $11.8 million in 2003. For the nine months
ended September 30, 2006 and 2005, our revenues were $3.3 million and $5.1 million, respectively.
We have received a limited amount of product-related revenue from research contracts, licenses and
agreements to provide vaccine products, services and adjuvant technologies. We cannot be certain
that we will be successful in entering into strategic alliances or collaborative arrangements with
other companies that will result in other significant revenues to offset our expenses. Our net
losses for the last three fiscal years were $11.2 million in 2005, $25.9 million in 2004 and $17.3
million in 2003, while they were $16.9 million and $17.3 million for the nine months ended
September 30, 2006 and 2005, respectively.
Our losses have resulted from research and development expenses, sales and marketing expenses
for ESTRASORB, protection of our intellectual property and other general operating expenses. Our
losses increased due to the launch of ESTRASORB as we expanded our manufacturing capacity and sales
and marketing capabilities, and may increase as and when we conduct additional and larger clinical
trials for our product candidates. Our losses have also increased, and may continue to increase, as
a result of ramped-up research and development efforts to support our development of flu vaccines.
Therefore, we expect our cumulative operating loss to increase until such time, if ever, product
sales, licensing fees, royalties, milestones, contract research and other sources generate
sufficient revenue to fund our continuing operations. We cannot predict when, if ever, we might
achieve profitability and cannot be certain that we will be able to sustain profitability, if
achieved.
Many of our competitors have significantly greater resources and experience, which may negatively
impact our commercial opportunities and those of our current and future licensees.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid
and significant
technological change. We have many potential competitors, including major drug and chemical
companies,
specialized biotechnology firms, academic institutions, government agencies and private and public
research
institutions. Many of our competitors have significantly greater financial and technical resources,
experience and
expertise in:
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research and development; |
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pre-clinical testing; |
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clinical trials; |
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regulatory processes and approvals; |
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production and manufacturing; and |
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sales and marketing of approved products. |
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Large and established companies such as Merck & Co., Inc., GlaxoSmithKline PLC, Novartis, Inc.
and MedImmune Inc., among others, compete in the vaccine market. In particular, these companies
have greater experience and expertise in securing government contracts and grants to support their
research and development efforts, conducting testing and trials, obtaining regulatory approvals to
market products, and manufacturing such products on a broad scale.
Smaller or early-stage companies and research institutions may also prove to be significant
competitors, particularly through collaborative arrangements with large and established
pharmaceutical or other companies. We will also face competition from these parties in recruiting
and retaining qualified scientific and management personnel, establishing clinical trial sites and
patient registration for clinical trials, and in acquiring and in-licensing technologies and
products complementary to our programs or potentially advantageous to our business. If any of our
competitors succeeds in obtaining approval from the Food and Drug
Administration (the FDA) or
other regulatory authorities for their products sooner than we do or for products that are more
effective or less costly than ours, our commercial opportunity could be significantly reduced.
In order to effectively compete, we will have to make substantial investments in sales and
marketing or partner with one or more established companies. There is no assurance that we will be
successful in gaining significant market share for any product or product candidate. Our
technologies and products also may be rendered obsolete or noncompetitive as a result of products
introduced by our competitors to the marketplace more rapidly and at a lower cost.
The return on our investment in ESTRASORB depends in large part on the success of our relationship
with Esprit and our ability to manufacture the product.
In October 2005, we entered into a License Agreement and a Supply Agreement with Esprit Pharma
for ESTRASORB. Under the License Agreement, we granted Esprit exclusive rights to market ESTRASORB
in North America. In consideration for such rights, Esprit paid us $12.5 million during the first
year. Novavax is also entitled to receive a royalty on all net sales of ESTRASORB as well as
sales-based milestone payments.
While our License Agreement with Esprit gives us some limited protections with respect to that
companys ESTRASORB marketing and sales efforts and, we believe, creates incentives for Esprit
consistent with our own, we cannot control the amount and timing of the marketing efforts that
Esprit devotes to ESTRASORB or make any assurances that Esprits promotion and marketing of
ESTRASORB in North America will be successful. We do not have a history of working together with
Esprit and cannot predict the success of the collaboration, nor can we give any assurances that
Esprit will not reduce or curtail its efforts to market ESTRASORB because of factors affecting its
business or operations beyond our control. Loss of Esprit as a partner in the commercialization of
ESTRASORB, any dispute over the terms of or decisions regarding the License and Supply Agreements,
or other adverse developments in our relationship with Esprit may harm our business and might
accelerate our need for additional capital. We also can give no assurances that Esprit will be
more successful than us in gaining market acceptance of ESTRASORB. Prescription trends for
ESTRASORB have not met our expectations to date and Esprit will face similar obstacles to gaining
market share of the estrogen therapy market, including competition from large and established
companies with similar estrogen therapy products.
Numerous companies worldwide currently produce and sell estrogen products for clinical
indications identical to those for ESTRASORB. Currently, the oral and patch product segments
account for approximately 75% and 15% of the market, respectively, according to 2004 Verispan data.
Wyeth commits significant resources to the sale and marketing of its product,
Premarin®, in order to maintain its market leadership position. Several other companies
compete in the estrogen category including Berlex Laboratories, Inc., Novartis Pharma AG and Solvay
Pharmaceuticals. In particular, Solvay has introduced an alcohol-based gel product, Estrogel,
which is directly
competitive with ESTRASORB. These and other products sold by our competitors have all
achieved a degree of market penetration superior to ESTRASORB.
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In addition, under the Supply Agreement, we are obligated to supply Esprit with ESTRASORB
through the manufacture of the product at our manufacturing facility in Philadelphia, Pennsylvania.
We have only limited experience with the large capacity manufacturing required for the commercial
sale of a product. Although we have validated our manufacturing methods for the product with the
FDA, we will remain subject to that agencys rules and regulations regarding good manufacturing
practices, which are enforced by the FDA through its facilities inspection program. Compliance
with such rules and regulations requires us to spend substantial funds and hire and retain
qualified personnel. We face the possibility that we may not be able to meet Esprits supply
requirements under the agreement in a timely fashion at acceptable quality, quantity and prices or
in compliance with applicable regulations. If our facility fails to comply with applicable
regulations, we will be forced to utilize a third party contractor to manufacture the product. We
may not be able to enter into alternative manufacturing arrangements at commercially acceptable
rates, if at all. Moreover, the manufacturers we use may not provide sufficient quantities of
product to meet our specifications or our delivery, cost and other requirements.
We must utilize our manufacturing facility for products other than ESTRASORB in order to avoid
operating the facility at a loss.
Currently we are manufacturing ESTRASORB at our facility in Philadelphia, Pennsylvania and it
is likely we will continue to manufacture ESTRASORB at a loss until production volumes increase or
we enter into additional contract manufacturing agreements with third parties to more fully utilize
our manufacturing facilitys capacity. The facility is able to accommodate much greater production
than its current schedule, which, if more fully utilized, would offset the fixed costs related to
the manufacturing process and facility. In addition, we are negotiating revisions to our agreements
for packaging costs of ESTRASORB as well as our fixed lease costs for the manufacturing facility.
If these negotiations result in higher packaging or lease costs for us, it may have a material
adverse impact on future financial results.
We have not completed the development of products other than ESTRASORB and we may not succeed in
obtaining the FDA approval necessary to sell additional products.
The development, manufacture and marketing of our pharmaceutical and biological products are
subject to government regulation in the United States and other countries. In the United States
and most foreign countries, we must complete rigorous preclinical testing and extensive human
clinical trials that demonstrate the safety and efficacy of a product in order to apply for
regulatory approval to market the product. ESTRASORB is the only product developed by the company
to have been approved for sale in the United States. Approval outside the U.S. may take longer or
may require additional clinical trials. We have product candidates in preclinical laboratory or
animal studies.
Before applying for FDA approval to market any new drug product candidates, we must first
submit an Investigational New Drug application (an IND) that explains to the FDA the results of
pre-clinical testing conducted in laboratory animals and what we propose to do for human testing.
At this stage, the FDA decides whether it is reasonably safe to move forward with testing the drug
on humans. We must then conduct Phase I studies and larger-scale Phase II and III human clinical
trials that demonstrate the safety and efficacy of our products to the satisfaction of the FDA.
Once these trials are complete, a New Drug Application (an NDA) can be filed with the FDA
requesting approval of the drug for marketing.
Vaccine clinical development follows the same general pathway as for drugs and other
biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an IND
describing the vaccine, its method of manufacture and quality control tests for release.
Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases. Initial
human studies, referred to as Phase I, are safety and immunogenicity studies performed in a small
number of closely monitored subjects. Phase II studies are dose-ranging studies and may enroll
hundreds of subjects. Finally, Phase III trials typically enroll thousands of individuals and
provide the critical documentation of effectiveness and important additional safety data required
for licensing.
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If successful, the completion of all three phases of clinical development can be followed by
the submission of a Biologics License Application (a BLA). Also during this stage, the proposed
manufacturing facility undergoes a pre-approval inspection during which production of the vaccine
as it is in progress is examined in detail. Vaccine approval also requires the provision of
adequate product labeling to allow health care providers to understand the vaccines proper use,
including its potential benefits and risks, to communicate with patients and parents, and to safely
deliver the vaccine to the public. Until a vaccine is given to the general population, all
potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase IV studies after
a BLA has been approved and the vaccine is licensed and on the market.
These processes are expensive and can take many years to complete, and we may not be able to
demonstrate the safety and efficacy of our products to the satisfaction of such regulatory
authorities. Regulatory authorities may also require additional testing and we may be required to
demonstrate that our proposed products represent an improved form of treatment over existing
therapies, which we may be unable to do so without conducting further clinical studies. Moreover,
if the FDA grants regulatory approval of a product, the approval may be limited to specific
indications or limited with respect to its distribution. Expanded or additional indications for
approved drugs may not be approved, which could limit our revenues. Foreign regulatory authorities
may apply similar limitations or may refuse to grant any approval. Consequently, even if we
believe that preclinical and clinical data are sufficient to support regulatory approval for our
product candidates, the FDA and foreign regulatory authorities may not ultimately grant approval
for commercial sale in any jurisdiction. If our drug candidates are not approved, our ability to
generate revenues may be limited and our business will be adversely affected.
We may fail to obtain regulatory approval for our products on a timely basis or comply with our
continuing regulatory obligations after approval is obtained.
Delays in obtaining regulatory approval can be extremely costly in terms of lost sales
opportunities and increased clinical trial costs. The speed with which we complete our clinical
trials and our applications for marketing approval will depend on several factors, including the
following:
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the rate of patient enrollment and retention, which is a function of many factors,
including the size of the patient population, the proximity of patients to clinical sites,
the eligibility criteria for the study and the nature of the protocol; |
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Institutional Review Board approval of the protocol and the informed consent form; |
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prior regulatory agency review and approval; |
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our ability to manufacture or obtain sufficient quantities of materials for use in clinical trials; |
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negative test results or side effects experienced by trial participants; |
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analysis of data obtained from preclinical and clinical activities, which are
susceptible to varying interpretations and which interpretations could delay, limit or
prevent regulatory approval; |
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changes in the policies of regulatory authorities for drug or vaccine approval during
the period of product development; and |
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the availability of skilled and experienced staff to conduct and monitor clinical
studies and to prepare the appropriate regulatory applications. |
We have limited experience in conducting and managing the preclinical and clinical trials
necessary to obtain regulatory marketing approvals. We may not be able to obtain the approvals
necessary to conduct clinical studies. We also face the risk that the results of our clinical
trials may be inconsistent with the results obtained in preclinical studies or that the results
obtained in later phases of clinical trials may be inconsistent with those obtained in earlier
phases. A number of companies in the specialty biopharmaceutical and product development industry
have suffered significant setbacks in advanced clinical trials, even after experiencing promising
results in early animal and human
testing. If regulatory approval of a drug is granted, such approval is likely to limit the
indicated uses for which it may be marketed.
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Furthermore, even if a product gains regulatory approval, the product and the manufacturer of
the product will be subject to continuing regulatory review, including adverse event reporting
requirements and the FDAs general prohibition against promoting products for unapproved uses.
Failure to comply with any post-approval requirements can, among other things, result in warning
letters, product seizures, recalls, fines, injunctions, suspensions or revocations of marketing
licenses, operating restrictions and criminal prosecutions. Any of these enforcement actions, any
unanticipated changes in existing regulatory requirements or the adoption of new requirements, or
any safety issues that arise with any approved products, could adversely affect our ability to
market products and generate revenues and thus adversely affect our ability to continue our
business.
We also may be restricted or prohibited from marketing or manufacturing a product, even after
obtaining product approval, if previously unknown problems with the product or its manufacture are
subsequently discovered and we cannot assure you that newly discovered or developed safety issues
will not arise following any regulatory approval. With the use of any drug by a wide patient
population, serious adverse events may occur from time to time that initially do not appear to
relate to the drug itself, and only if the specific event occurs with some regularity over a period
of time does the drug become suspect as having a causal relationship to the adverse event. Any
safety issues could cause us to suspend or cease marketing of our approved products, possibly
subject us to substantial liabilities, and adversely affect our ability to generate revenues and
our financial condition.
Our substantial indebtedness could adversely affect our cash flow and prevent us from fulfilling
our obligations.
As of September 30, 2006, we had $22.7 million of outstanding indebtedness. Our substantial
amount of outstanding indebtedness could have significant consequences. For example, it:
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could increase our vulnerability to general adverse economic and industry conditions; |
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requires us to dedicate a substantial portion of our cash flow from operations to
service payments on our indebtedness, reducing the availability of our cash flow to fund
future capital expenditures, working capital, execution of our growth strategy, research
and development costs and other general corporate requirements; |
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could limit our flexibility in planning for, or reacting to, changes in our business and
the industry, which may place us at a competitive disadvantage compared with competitors
that have less indebtedness; and |
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could limit our ability to obtain additional funds, even when necessary to maintain
adequate liquidity. |
We may incur additional indebtedness for various reasons, which would increase the risks
associated with our substantial leverage.
Health care insurers and other payors may not pay for our products or may impose limits on
reimbursement.
Our ability and the ability of our licensees to successfully commercialize ESTRASORB and
future products will depend, in part, on the extent to which reimbursement for such products will
be available from third-party payors such as Medicare, Medicaid, health maintenance organizations,
health insurers and other public and private payors. If we succeed in bringing products to the
market, we cannot be assured that third-party payors will pay for such products or establish and
maintain price levels sufficient for realization of an appropriate return on our investment in
product development. For example, ESTRASORB currently is being sold as an outpatient prescription
drug. Medicare does not cover the costs of most outpatient prescription drugs. We expect that over
time ESTRASORB will be treated the same as other estrogen therapy products with respect to
government and third-party payor reimbursement, however, additional time is required to increase
the number of payors who currently accept our product for reimbursement. There can be no assurance
that ESTRASORB will receive similar reimbursement treatment.
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Many health maintenance organizations and other third-party payors use formularies, or lists
of drugs for which
coverage is provided under a health care benefit plan, to control the costs of prescription
drugs. Each payor that maintains a drug formulary makes its own determination as to whether a new
drug will be added to the formulary and whether particular drugs in a therapeutic class will have
preferred status over other drugs in the same class. This determination often involves an
assessment of the clinical appropriateness of the drug and, in some cases, the cost of the drug in
comparison to alternative products. There can be no assurance that ESTRASORB or any of our future
products will be added to payors formularies, that our products will have preferred status to
alternative therapies, or that the formulary decisions will be conducted in a timely manner. We may
also decide to enter into discount or formulary fee arrangements with payors, which could result in
us receiving lower or discounted prices for ESTRASORB or future products.
We may have product liability exposure.
The administration of drugs to humans, whether in clinical trials or after marketing
clearances are obtained, can result in product liability claims. We maintain product liability
insurance coverage in the total amount of $10.0 million for claims arising from the use of our
currently marketed products and products in clinical trials prior to FDA approval. Coverage is
becoming increasingly expensive, however, and we may not be able to maintain insurance at a
reasonable cost. There can be no assurance that we will be able to maintain our existing insurance
coverage or obtain coverage for the use of our other products in the future. This insurance
coverage and our resources may not be sufficient to satisfy liabilities resulting from product
liability claims. A successful claim may prevent us from obtaining adequate product liability
insurance in the future on commercially desirable terms, if at all. Even if a claim is not
successful, defending such a claim would be time-consuming and expensive, may damage our reputation
in the marketplace, and would likely divert managements attention.
We have made loans to certain of our directors, which could have a negative impact on our stock
price.
In 2002, pursuant to our 1995 Stock Option Plan, we approved the payment of the exercise price
of options by two of our directors through the delivery of full-recourse, interest-bearing
promissory notes in the aggregate principal amount of approximately $1.5 million, secured by a
pledge of the underlying shares. As of September 30, 2006, accrued interest receivable related to
the borrowing was $340,000. Due to heightened sensitivity in the current environment surrounding
related-party transactions, these transactions could be viewed negatively in the market and our
stock price could be negatively affected. Our corporate governance policies have been revised and
our 2005 Stock Incentive Plan prohibits any additional loans or guarantees to directors.
RISKS RELATED TO OUR SECURITIES
The price of our common stock has been and may continue to be volatile.
Historically, the market price of our common stock has fluctuated over a wide range. In
fiscal year 2005, our common stock traded in a range from $0.70 to $6.01. Between January 1, 2006
and November 20, 2006, our common stock traded in a range from $2.84 to $8.39. It is likely that
the price of our common stock will fluctuate in the future. The market prices of securities of
small-capitalization, biopharmaceutical companies, including ours, from time to time experience
significant price and volume fluctuations unrelated to the operating performance of these
companies. In particular, the market price of our common stock may fluctuate significantly due to a
variety of factors, including:
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governmental agency actions including the FDAs determination with respect to new drug
applications for new products; |
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our ability to obtain financing; |
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our ability to obtain government contracts to develop vaccines and other biological
products and technologies; and |
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our ability to develop additional products, including biologicals and vaccines. |
In addition, the occurrence of any of the risks described in these Risk Factors could have a
material and
adverse impact on the market price of our common stock.
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The conversion of our outstanding convertible debt, and the issuance of shares of our common stock
upon conversion or exercise of preferred stock and/or warrants or in future offerings would cause
dilution of existing security holders interests in the company and may cause the price of our
common stock to go down.
As of September 30, 2006, we had outstanding convertible notes in the aggregate principal
amount of $22,000,000 that as of such date were convertible into an aggregate of 4,029,304 shares
of our common stock. The issuance of shares of our common stock upon conversion of such notes, as
well as in connection with future capital raising activities, would cause immediate and potentially
substantial equity dilution for existing stockholders and the price of our common stock could be
subject to significant downward pressure.
We have never paid dividends on our capital stock, and we do not anticipate paying any such
dividends in the foreseeable future.
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future. In addition, the terms of our existing and any
future debt may preclude us from paying dividends. As a result, capital appreciation, if any, of
our common stock would be the only source of gain for stockholders until dividends are permitted
and paid.
Provisions of our Certificate of Incorporation and By-laws, Delaware law, and our Shareholder
Rights Plan could delay or prevent the acquisition of the company, even if such acquisition would
be beneficial to stockholders, and could impede changes in our Board.
Provisions of Delaware corporate law and our organizational documents could hamper a third
partys attempt to acquire, or discourage a third party from attempting to acquire control of, the
company. Moreover, our shareholder rights plan empowers our Board to delay or negotiate, and
thereby possibly thwart, any tender offer or takeover attempt the Board opposes. Stockholders who
wish to participate in these transactions may not have the opportunity to do so. These provisions
also could limit the price investors are willing to pay in the future for our securities and make
it more difficult to change the composition of our Board in any one year. These provisions include
the right of the Board to issue preferred stock with rights senior to those of the common stock
without any further vote or action by stockholders, the existence of a staggered Board with three
classes of directors serving staggered three-year terms, advance notice requirements for
stockholders to nominate directors and make proposals, and a Delaware statutory provision
prohibiting certain transactions between Novavax and interested stockholders.
- 12 -
ABOUT THIS PROSPECTUS
This prospectus is part of a shelf registration statement that we filed with the Securities
and Exchange Commission (the SEC or Commission). By using a shelf registration statement, we
may, from time to time, issue and sell in one or more series or classes our common stock, preferred
stock and/or warrants in one or more offerings up to an aggregate maximum offering price of
$100,000,000 (or its equivalent in foreign or composite currencies). Each time we sell
any of our securities, we will provide a prospectus supplement that will contain more specific
information about the offering and the terms of the securities being sold. We may also add, update
or change in the prospectus supplement any of the information contained in this prospectus or the
documents incorporated by reference.
This prospectus and the prospectus supplements provide you with a general description of the
company and our securities; for further information about our business and our securities, you
should refer to the registration statement, the reports incorporated by reference in this
prospectus, as described in Where You Can Find More Information.
You should rely only on the information contained in this prospectus and in any prospectus
supplement (including in any documents incorporated by reference herein or therein). We have not
authorized anyone to provide you with any different information. We are offering to sell our
securities, and seeking offers to buy, only in jurisdictions where offers and sales are permitted.
The information contained in this prospectus and any prospectus supplement is accurate only as of
the date of this prospectus or such prospectus supplement, and the information contained in any
document incorporated herein or therein by reference is accurate only as of the date of such
document incorporated by reference, regardless of the time of delivery or any sale of our
securities.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus and any accompanying prospectus supplement (including any
documents incorporated by reference herein or therein) contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on
managements beliefs and assumptions and on information currently available, and use words such as
expect, anticipate, intend, plan, believe, estimate, may, could, possible,
forecast, or similar words and expressions. Forward-looking statements include but are not
limited to statements regarding usage of cash, product sales, future product development and
related clinical trials, and future research and development, including FDA approval of our product
candidates. Forward-looking statements are only predictions, and necessarily involve risks and
uncertainties and other factors that may cause the actual results, performance or achievements of
Novavax, or industry results, to be materially different from those anticipated in or implied by
the forward-looking statements. These risks, uncertainties and other factors are discussed in the
Risk Factors section and elsewhere in this prospectus and any accompanying prospectus supplement
(including any documents incorporated by reference herein or therein) and include, among other
things, the following:
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general economic and business conditions; |
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ability to enter into future collaborations with industry partners; |
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competition; |
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unexpected changes in technologies and technological advances; |
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ability to obtain rights to technology; |
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ability to obtain and enforce patents; |
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ability to commercialize and manufacture products; |
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ability to maintain commercial-scale manufacturing capabilities; |
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results of clinical studies; |
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progress of research and development activities; |
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business abilities and judgment of personnel; |
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availability of qualified personnel; |
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changes in, or failure to comply with, governmental regulations; |
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ability to obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity financings or otherwise; and |
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other factors referenced in this prospectus and any accompanying prospectus
supplement (including any documents incorporated by reference herein or therein). |
We undertake no obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise. You are advised, however, to consult any
further disclosures we make on related subjects in our 10-Q, 8-K and 10-K reports to the SEC.
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USE OF PROCEEDS
Except as otherwise described in an applicable prospectus supplement, we currently intend to
use the net proceeds from this offering for general corporate purposes, which may include:
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clinical development of VLP-based avian and seasonal flu vaccines, including the
development of appropriate adjuvants, and demonstration of large-scale production
capabilities, for such vaccines; |
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our internal research and development programs, such as preclinical and clinical
testing and studies of our product candidates and the development of new
technologies; |
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expansion of and investment in our research and development facilities,
including compliance with current Good Manufacturing Practices (cGMP)
and Good Laboratory Practices (GLP) rules and regulations; and |
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general working capital. |
Each time we issue securities, we will provide a prospectus supplement that will contain
information about how we intend to use the proceeds from each such offering.
At this time, we have not determined the specific uses of any offering proceeds, or the
amounts we plan to spend on any particular use or the timing of such expenditures, which may vary
significantly depending on various factors such as our research and development results, regulatory
approvals, competition, marketing and sales, and the market acceptance of any products introduced
by us or our partners. Pending application of the net proceeds from any particular offering, we
intend to invest such proceeds in short-term, interest-bearing, investment-grade securities.
We cannot guarantee that we will receive any proceeds in connection with any offering
hereunder because we may choose not to issue any of the securities covered by this prospectus.
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PLAN OF DISTRIBUTION
We may sell the securities being offered hereby from time to time in one or more of the
following ways:
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through one or more underwriters, |
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through dealers, who may act as agents or principal (including a block trade in
which a broker or dealer so engaged will attempt to sell the shares as agent but
may position and resell a portion of the block as principal to facilitate the
transaction), |
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directly to one or more purchasers, |
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through agents, |
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in privately negotiated transactions, and |
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in any combination of these methods of sale. |
We will set forth in a prospectus supplement the terms of the offering of securities, including:
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the name or names of any agents, underwriters or dealers, |
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the terms of the securities being offered, including the purchase price and the
proceeds we will receive from the sale, |
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any underwriting discounts and commissions or agency fees and other items
constituting underwriters or agents compensation, |
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any over-allotment options under which underwriters may purchase additional
securities from us, and |
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any discounts or concessions allowed or reallowed or paid to dealers. |
The distribution of the securities may be effected 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 the prevailing market prices, or at negotiated prices.
Underwriters, dealers, agents and others that participate in the distribution of the
securities may be underwriters as defined in the Securities Act of 1933, as amended (the
Securities Act) and any discounts or commissions they receive from us and any profit on their
resale of the securities may be treated as underwriting discounts and commissions under the
Securities Act. We will identify in the applicable prospectus supplement any underwriters,
dealers, agents and others and will describe their compensation. We may have agreements with
underwriters, dealers, agents and others to indemnify them against specified civil liabilities,
including liabilities under the Securities Act. Underwriters, dealers, agents and others may
engage in transactions with or perform services for us in the ordinary course of their businesses.
We have not entered into any agreements, understandings or arrangements with any underwriters,
broker-dealers or other parties regarding the sale of securities. As of the date of this
prospectus, there were no special selling arrangements between any broker-dealer or other person
and the company. No period of time has been fixed within which the securities will be offered or
sold.
If required under applicable state securities laws, we will sell the securities only through
registered or licensed brokers or dealers. In addition, in some states, we may not sell securities
unless they have been registered or qualified for sale in the applicable state or unless we have
complied with an exemption from any registration or qualification requirements.
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Agents
We may designate agents who agree to solicit purchases for the period of their appointment or
to sell securities on a continuing basis. Unless the prospectus supplement provides otherwise,
agents will act on a best efforts basis for the period of their appointment. Agents may receive
compensation in the form of commissions, discounts or concessions from us. Agents may also receive
compensation from the purchasers of the securities for whom they sell as principals. Each
particular agent will receive compensation in amounts negotiated in connection with the sale, which
might be in excess of customary commissions.
Underwriters
If we use underwriters for a sale of securities, the underwriters will acquire the securities
for their own account. The underwriters may resell the securities in one or more transactions,
including negotiated 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. Unless the
prospectus supplement provides otherwise, underwriters will be obligated to purchase all of the
securities offered by the prospectus supplement. We may change from time to time any initial
public offering price and any discounts or concessions the underwriters allow or reallow or pay to
dealers. We may use underwriters with whom we have a material relationship, and we may offer the
securities to the public through an underwriting syndicate or through a single underwriter. We
will describe in the prospectus supplement naming the underwriter the nature of any such
relationship and underwriting arrangement.
Dealers
We also may sell securities to a dealer as principal. If we sell our securities to a dealer
as a principal, then the dealer may resell those securities to the public at varying prices to be
determined by such dealer at the time of resale. The name of the dealer and the terms of the
transactions will be set forth in the applicable prospectus supplement.
Direct Sales and Institutional Purchases
We may also sell securities directly to one or more purchasers, in which case underwriters or
agents would not be involved in the transaction.
Further, we may authorize agents, underwriters or dealers to solicit offers by certain types
of institutional investors to purchase securities from us 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. We will describe the conditions to these contracts and the
commissions we must pay for solicitation of these contracts in an applicable prospectus supplement.
Stabilization Activities
Any underwriter may engage in overallotment, stabilizing transactions, short covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act of 1934, as
amended (the Exchange Act). Overallotment 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. Short covering transactions
involve purchases 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 covering transaction to cover short
positions. Such activities may cause the price of the securities to be higher than they would
otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
These transactions may be effected on the NASDAQ Global Market or otherwise.
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Passive Market Making
Any underwriters who are qualified market makers on the NASDAQ Global Market may engage in
passive market making transactions on the NASDAQ Global Market in accordance with Rule 103 of
Regulation M, during the business day prior to the pricing of the offering, before the commencement
of offers or sales. 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 makers bid, however, the passive market
makers bid must then be lowered when certain purchase limits are exceeded.
Costs
We will bear all costs, expenses and fees in connection with the registration of the
securities, as well as the expense of all commissions and discounts, if any, attributable to sales
of the securities by us.
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DESCRIPTION OF OUR CAPITAL STOCK
Set forth below is a summary of the material terms of our capital stock. This summary is not
complete. We encourage you to read our Amended and Restated Certificate of Incorporation (the
Certificate of Incorporation) and our Amended and Restated By-laws (the By-laws) that we have
previously filed with the SEC. See Where You Can Find More Information.
General
Our authorized capital stock consists of: (i) 100,000,000 shares of common stock, par value
$.01 per share, of which 61,684,361 shares were outstanding as of November 15, 2006, and (ii)
2,000,000 shares of preferred stock, par value $.01 per share, none of which are outstanding.
Common Stock
Holders of common stock are entitled to one vote for each share held on all matters submitted
to a vote of stockholders and do not have cumulative voting rights. Generally, all matters to be
voted on by stockholders must be approved by a majority, or, in the case of the election of
directors, by a plurality, of the votes cast at a meeting at which a quorum is present.
Holders of our common stock are entitled to receive ratably such dividends, if any, as may be
declared by the Board of Directors out of funds legally available therefor, subject to any
preferential dividend rights of any outstanding preferred stock. Upon the liquidation, dissolution
or winding up of the company, the holders of our common stock are entitled to receive ratably the
net assets of the company available after the payment of all debts and liabilities and subject to
the prior rights of any outstanding preferred stock.
Holders of our common stock are not entitled to pre-emptive rights or any rights of
conversion. Shares of our common stock are, and the shares being distributed in this offering will
be, when issued, fully paid and nonassessable. The rights, preferences and privileges of holders
of our common stock are subject, and may be adversely affected by, the rights of holders of shares
of any series of preferred stock which we may designate and issue in the future.
Our common stock is traded on the NASDAQ Global Market under the symbol NVAX. On November 20,
2006, the closing price of our common stock as reported on the NASDAQ Global Market was $5.28 per
share.
Our registrar and transfer agent for all shares of common stock is Computershare Limited, 250
Royall Street, Canton, MA 02021.
Preferred Stock
The Board of Directors may, without further action by the stockholders of the company, issue
preferred stock in one or more series and fix the rights and preferences thereof. Our Certificate
of Incorporation grants the Board of Directors authority to issue preferred stock and to determine
its rights and preferences without the need for further stockholder approval to eliminate delays
associated with a stockholder vote on specific issuances.
Examples of rights and preferences the Board of Directors may fix include dividend rights,
dividend rates, conversion rights, voting rights, pre-emptive rights, terms of redemption
(including sinking fund provisions), redemption prices and liquidation preferences. The issuance
of preferred stock, while providing desirable flexibility in connection with possible financings,
could have the effect of making it more difficult for a third party to acquire, or of discouraging
a third party from acquiring, a majority of the outstanding voting stock of the company. The
rights of holders of our common stock, described above, will be subject to, and may be adversely
affected by, the rights of any preferred stock that we may designate and issue in the future.
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The terms of any particular series of preferred stock will be described in the prospectus
supplement relating to the offering of shares of that particular series of preferred and may
include, among other things:
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the title and stated value; |
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the number of shares authorized; |
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the liquidation preference per share; |
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the purchase price; |
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the dividend rate, period and payment date, and method of calculation (including
whether cumulative or non-cumulative); |
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terms and amount of any sinking fund; |
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provisions for redemption or repurchase, if applicable, and any restrictions on
the ability of the company to exercise such redemption and repurchase rights; |
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conversion rights and rates, if applicable, including the conversion price and
how and when it will be calculated and adjusted; |
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voting rights, if any; |
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preemptive rights, if any; |
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restrictions on sale, transfer and assignment, if any; |
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the relative ranking and preferences of the preferred stock; and |
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any other specific terms, rights or limitations of, or restrictions on, such preferred stock. |
Please also refer to the description of our Shareholder Rights Plan, below, for a discussion
of the companys Series D Junior Participating Preferred Stock.
Shareholder Rights Plan
We have adopted a Shareholder Rights Plan pursuant to which the Board of Directors declared a
dividend distribution of one preferred stock purchase right for each outstanding share of common
stock. Each right, once exercisable, entitles the holder to purchase from us one one-thousandth
(1/1,000th) of a share of Series D Junior Participating Preferred Stock (the Series D Preferred
Stock), at a price of $40.00, subject to certain adjustments.
The rights, unless earlier redeemed by the Board, become exercisable upon the close of
business on the day which is the earlier of (i) the tenth business day following a public
announcement that a person or group of affiliated or associated persons (with certain exceptions)
has acquired beneficial ownership of 15% or more of the outstanding voting stock of the company,
and (ii) the tenth business day after the date of the commencement by any person of a tender or
exchange offer, the consummation of which would result in such person or group of affiliated or
associated persons becoming an acquiring person as defined in the rights plan. The rights expire
at the close of business on August 7, 2012, unless earlier redeemed or exchanged by us as described
below.
Unless the rights are earlier redeemed, in the event that a person or group becomes an
acquiring person, the rights plan provides that proper provisions will be made so that each
holder of record of a right (other than rights beneficially owned by an acquiring person and
certain of its affiliates, associates and transferees) will thereafter have the right to receive,
upon payment of the exercise price, that number of shares of the Series D Preferred Stock having a
fair market value determined in accordance with the rights plan at the time of the transaction
equal to approximately two times the exercise price (such value to be determined with reference to
the fair market value of our common stock as provided in the plan).
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In addition, unless the rights are earlier redeemed or exchanged, in the event that, after the
time that a person or group becomes an acquiring person, we were to be acquired in a merger or
other business combination (in which any shares of common stock are changed into or exchanged for
other securities or assets) or more than 50% of the assets or earning power of the company and its
subsidiaries (taken as a whole) were to be sold or transferred in one or a series of related
transactions, the rights plan provides that proper provision will be made so that each holder of
record of a right (other than rights beneficially owned by an acquiring person and certain of its
affiliates, associates and transferees) will have the right to receive, upon payment of the
exercise price, that number of shares of common stock of the acquiring company having a fair market
value at the time of such transaction determined in accordance with the rights plan equal to
approximately two times the exercise price.
At any time after any person or group becomes an acquiring person and prior to the acquisition
by such person or group of 50% or more of the outstanding voting stock, the Board may exchange the
rights, in whole or in part, for that number of shares of the Series D Preferred Stock having a
fair market value on the date such person or group became an acquiring person equal to the excess
of (i) the fair market value of Series D Preferred Stock issuable upon the exercise of the rights
over (ii) the exercise price of the rights, in each case subject to anti-dilution adjustments.
At any time prior to the close of business on the tenth business day after there has been a
public announcement that a person has become an acquiring person or such earlier date as a majority
of the Board shall become aware of the existence of an acquiring person, we may redeem the rights
in whole, but not in part, at a price of $.001 per right. Immediately upon the effective time of
such Board action, the right to exercise the rights will terminate and the only right of the
holders will be to receive the redemption price.
For as long as the rights are then redeemable, we may, except with respect to the redemption
price, amend the rights in any manner, including extending the time period in which the rights may
be redeemed. At any time when the rights are not then redeemable, we may amend the rights in any
manner that does not materially adversely affect the interests of holders of the rights as such.
Provisions of our Certificate of Incorporation and By-laws and Delaware Law
Certain provisions of our Certificate of Incorporation and By-laws may be deemed to have an
anti-takeover effect and may prevent, delay or defer a tender offer or takeover attempt that a
stockholder may deem in his, her or its best interest. The existence of these provisions also
could limit the price that investors might be willing to pay for our securities. They include:
Staggered Board, Removal of Directors and Charter Amendments relating to the Board
Our Certificate of Incorporation and By-laws provide for the division of our Board of
Directors into three classes, with no one class having more than one director more than any other
class, serving staggered three year terms. Our By-laws further provide that directors may be
removed only for cause by the affirmative vote of the holders of 2/3 of the shares of capital stock
of the company issued and outstanding and entitled to vote. Moreover, our Certificate of
Incorporation provides that any amendments to the charter relating to the number, classes,
election, term, removal, vacancies and related provisions with respect to the Board may only be
made by the affirmative vote of the holders of at least 75% of the shares of capital stock issued
and outstanding and entitled to vote. These provisions may have the effect of making it more
difficult for a third party to acquire control of Novavax, or of discouraging a third party from
acquiring control of the company.
Authorized but Unissued Shares
The authorized but unissued shares of our common stock and preferred stock are available for
future issuance without stockholder approval, subject to any limitations imposed by the NASDAQ
Stock Market. These additional shares may be utilized for a variety of corporate purposes. In
particular, although our Board of Directors has no present intention to do so, it could issue
shares of preferred stock that could, depending on the terms of the series, impede the completion
of a merger, tender offer, proxy contest or other takeover attempt. Our Board may determine that
the issuance of such shares of preferred stock is in the best interest of the company and our
stockholders. Such issuance could discourage a potential acquiror from making an unsolicited
acquisition attempt
through which such acquiror may be able to change the composition of the board, including a tender
offer or other transaction that some, or a majority, of our stockholders might believe to be in
their best interest or in which stockholders might receive a premium for their stock over the
then-current market price.
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Advance Notice Requirements for Stockholder Proposals and Director Nominations
Our By-laws provide that a stockholder seeking to bring business before an annual meeting of
stockholders, or to nominate candidates for election as directors, must provide timely notice of
such stockholders intention in writing. To be timely, a stockholders notice must be received not
less than 60 nor more than 90 days prior to the meeting at which such candidate or proposal is to
be considered. However, if the company does not give prior notice or make public disclosure of the
date of the meeting at least 70 days prior to the meeting date, notice is considered timely if it
is received no later than the close of business on the 10th day following the date on
which such notice was given or public disclosure was made (whichever occurred first). If a
stockholder desires to have a proposal included in the companys proxy statement, notice of such
proposal must be received not less than 120 days prior to the first anniversary of the date of the
companys notice of the previous years annual meeting. These advance notice provisions may
preclude stockholders from bringing matters before a meeting or from making nominations for
directors.
Special Meetings of Stockholders
Our By-laws provide that special meetings of stockholders may be called by the Chief Executive
Officer (or, if there is no Chief Executive Officer, the President) or by the Board of Directors,
with no provision for any right of stockholders to call such meetings. Further, business
transacted at any special meeting of stockholders is limited to matters relating to the purpose or
purposes stated in the notice of meeting.
Section 203 of the General Corporation Law of the State of Delaware
We are subject to the provisions of Section 203 of the General Corporation Law of the State of
Delaware. Subject to certain exceptions, Section 203 prohibits a publicly-held Delaware corporation
from engaging in a business combination with an
interested stockholder for a period of three
years after the time such person became an interested stockholder, unless the interested
stockholder attained such status with the approval of our Board of Directors or unless the business
combination is approved in a prescribed manner. A business
combination is defined to include a
merger, asset sale or other transaction resulting in a financial benefit to the interested
stockholder. Subject to various exceptions, an interested stockholder is a person who, together
with affiliates and associates, owns, or within the past three years did own, 15% or more of a
corporations voting stock. This statutory provision could prohibit or delay the accomplishment of
mergers or other takeover or change in control attempts with respect to us and, accordingly, may
discourage attempts to acquire the company.
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DESCRIPTION OF OUR WARRANTS
This description summarizes only the terms of any warrants that we may offer under this
prospectus and related warrant agreements and certificates. You should refer to the warrant
agreement, including the form of warrant certificate representing the warrants, relating to the
specific warrants being offered for complete terms, which will be described and included in an
accompanying prospectus supplement. Such warrant agreement, together with the warrant certificate,
will be filed with the SEC in connection with the offering of the specific warrants.
We may issue warrants for the purchase of common or preferred stock. Warrants may be issued
independently or together with common or preferred stock, and may be attached to or separate from
any offered securities.
We will evidence each series of warrants by warrant certificates that we will issue under a
separate warrant agreement. We may enter into the warrant agreement with a warrant agent and, if
so, we will indicate the name and address of the warrant agent in the applicable prospectus
supplement relating to the particular series of warrants.
The particular terms of any issue of warrants will be described in the prospectus supplement
relating to the series. Those terms may include:
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the title of such warrants; |
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the aggregate number of such warrants; |
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the price or prices at which such warrants will be issued; |
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the currency or currencies (including composite currencies) in which the price
of such warrants may be payable; |
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the terms of the securities issuable upon exercise of such warrants and the
procedures and conditions relating to the exercise of such warrants; |
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the price at which the securities issuable upon exercise of such warrants may be acquired; |
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the dates on which the right to exercise such warrants will commence and expire; |
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any provisions for adjustment of the number or amount of securities receivable
upon exercise of the warrants or the exercise price of the warrants; |
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if applicable, the minimum or maximum amount of such warrants that may be
exercised at any one time; |
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if applicable, the designation and terms of the securities with which such
warrants are issued and the number of such warrants issued with each such security
or principal amount of such security; |
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if applicable, the date on and after which such warrants and the related
securities will be separately transferable; |
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information with respect to book-entry procedures, if any; and |
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any other terms of such warrants, including terms, procedures and limitations
relating to the exchange or exercise of such warrants. |
The prospectus supplement relating to any warrants to purchase equity securities may also
include, if applicable, a discussion of certain U.S. federal income tax and ERISA considerations.
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The company currently does not have any outstanding warrants.
Exercise of Warrants
Each warrant will entitle its holder to purchase the number of shares of common or preferred
stock at the exercise price set forth in, or calculable as set forth in, the applicable prospectus
supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the
warrants may exercise the warrants at any time up to the expiration date set forth in the
applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void. We will specify the place or places where, and the manner in which,
warrants may be exercised in the applicable prospectus supplement. We will set forth on the
reverse side of the applicable certificate and in the applicable prospectus supplement the
information that the holder of the warrant will be required to deliver upon exercise.
Upon receipt of payment and the warrant certificate properly completed and duly executed, we
will, as soon as practicable, forward the purchased securities. If less than all of the warrants
represented by the warrant certificate are exercised, a new warrant certificate will be issued for
the remaining 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, such
holders warrants.
Prior to the exercise of any warrants to purchase preferred stock or common stock, holders of
the warrants will not have any of the rights of holders of the preferred stock or common stock
purchasable upon exercise, including the right to vote or to receive any payments of dividends.
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DESCRIPTION OF OUR UNITS
We may issue units comprised of two or more of the other securities described in this
prospectus in any combination. 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 units may be issued under units agreements
to be entered into between us and a bank or trust company, as unit agent, as detailed in the
prospectus supplement relating to units being offered. The prospectus supplement will describe:
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the designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances the securities comprising the
units may be held or transferred separately; |
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a description of the terms of any unit agreement governing the units; |
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a description of the provisions for the payment, settlement, transfer or exchange of the units; |
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a discussion of material federal income tax considerations, if applicable; and |
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whether the units will be issued in fully registered or global form. |
The descriptions of the units in this prospectus and in any prospectus supplement are
summaries of the material provisions of the applicable agreements. These descriptions do not
restate those agreements in their entirety and may not contain all the information that you may
find useful. We urge you to read the applicable agreements because they, and not the summaries,
define your rights as holders of the units. For more information, please review the form of the
relevant agreements, which will be filed with the SEC promptly after the offering of units and will
be available as described under the heading Where You Can Find Additional Information.
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DIVIDEND POLICY
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future.
LEGAL MATTERS
Certain legal matters with respect to the securities offered hereby have been passed upon by
Ballard Spahr Andrews & Ingersoll, LLP.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2005, and managements assessment of the effectiveness of our internal control over financial
reporting as of December 31, 2005, as set forth in their reports, which are incorporated by
reference in this prospectus and elsewhere in the registration statement. Our financial statements
and managements assessment are incorporated by reference in reliance on Ernst & Young LLPs
report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Exchange Act, and in accordance with
the Exchange Act we file reports and other information with the SEC. These reports and other
information are not incorporated by reference in this prospectus and do not form a part of this
prospectus except as stated below under Incorporation of Certain Information by Reference. You
may read and copy these reports and other information filed with the SEC at the SECs Public
Reference Room located at 100 F Street, N.E., Washington, D.C. 20549. You can request copies of
these documents, for a copying fee, by writing to the SEC. Please call the SEC at 1-800-SEC-0330
or visit the SECs website for more information about the operation of the public reference room.
Our filings with the SEC are also available to you over the Internet at the SECs web site at
http://www.sec.gov. The companys web site is http://www.novavax.com.
Our common stock is traded on the NASDAQ Global Market under the symbol NVAX. Materials we
file can also be inspected at the offices of NASDAQ Operations at 1735 K Street, Washington, D.C.
20006.
We have filed a registration statement on Form S-3 (together with all amendments and exhibits,
which we refer to as the registration statement) with the SEC under the Securities Act with respect
to the securities offered by this prospectus. This prospectus, which constitutes a part of the
registration statement, does not contain all the information in the registration statement. For
further information about us and our securities, see the registration statement and its exhibits.
Statements made in this prospectus as to the content of any contract, agreement or other document
are not necessarily complete. With respect to each such contract, agreement or other document
filed as an exhibit to the registration statement, reference is made to the exhibit for a more
complete description of the matter involved, and each such statement shall be deemed qualified in
its entirety by such reference.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference in this prospectus the information in other
documents that we file with it, which means that we can disclose important information to you by
referring you to those documents containing such information. This prospectus is part of a
registration statement we filed with the SEC. You should rely on the information incorporated by
reference in this prospectus and the registration statement. The information incorporated by
reference is considered to be part of this prospectus and information we file later with the SEC
will automatically update and supersede this information and information contained in documents
filed earlier with the Commission. We incorporate by reference the documents listed below and any
future filings made with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior
to the termination of the offering; provided, that
we are not incorporating by reference any documents or information deemed to have been furnished
and not filed in accordance with SEC rules. The documents we are incorporating by reference are:
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Annual Report on Form 10-K for the fiscal year ended December 31, 2005; |
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Quarterly Reports on Form 10-Q for the quarters ended: |
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March 31, 2006; |
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June 30, 2006; and |
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September 30, 2006; |
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Current Reports on Form 8-K filed with the SEC on March 1, 2006 (Items 1.01 and 9.01);
March 21, 2006 (Items 1.01 and 9.01); April 21, 2006 (Items 4.01 and 9.01); May 19, 2006
(Item 5.02); May 26, 2006 (Items 5.02 and 9.01); July 12, 2006 (Item 3.01); August 17, 2006
(Items 1.01, 5.02 and 9.01); and September 7, 2006 (Items 5.02 and 9.01); |
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Definitive Proxy Statement with respect to the Annual Meeting of Stockholders held on
April 26, 2006, as filed with the SEC on March 23, 2006; and |
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The description of our common stock contained in the Registration Statement on Form 10
filed with the SEC on September 14, 1995. |
You may request a copy of any and all documents incorporated by reference herein (other than
exhibits to such documents unless such exhibits are specifically incorporated by reference into the
documents that this prospectus incorporates) at no cost by writing or telephoning our chief
financial officer at the following address and telephone number: Novavax, Inc., 508 Lapp Road,
Malvern, Pennsylvania 19355; (484) 913-1200. Attn: Jeffrey W. Church.
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