e424b5
This Filing is made pursuant to Rule 424(b)(5)
of the Securities Act of 1933, as amended,
in connection with Registration Statement No. 333-108006
Prospectus Supplement
(to Prospectus dated November 12, 2003)
4,186,047 SHARES
NOVAVAX, INC.
COMMON STOCK
We are offering 4,186,047 shares of our common stock, par value $.01 per share, pursuant
to this prospectus supplement. In connection with this offering, we will pay fees to Rodman &
Renshaw, LLC as placement agent. See Plan of Distribution beginning on page S-16 of this
prospectus supplement for more information regarding this arrangement.
Our common stock is traded on the Nasdaq National Market under the symbol NVAX. On October
31, 2005, the closing price of our common stock as reported on the Nasdaq National Market was $4.04
per share.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. THESE RISKS ARE DESCRIBED UNDER
THE CAPTION RISK FACTORS BEGINNING ON PAGE S-4 OF THIS PROSPECTUS SUPPLEMENT.
Neither the Securities and Exchange Commission nor any state securities regulators have
approved or disapproved of these securities or determined if this prospectus supplement or the
accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal
offense.
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Per Share |
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Offering |
Public offering price |
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$ |
4.300 |
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$ |
18,000,000 |
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Placement agent fee |
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$ |
0.215 |
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$ |
900,000 |
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Proceeds, before expenses, to Novavax |
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$ |
4.085 |
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$ |
17,100,000 |
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We estimate the total expenses of this offering, excluding the placement agent fee, will be
approximately $75,000. The placement agent is not required to arrange for the sale of any specific
number or dollar amount of the shares of common stock offered in this offering. This offering will
end on or prior to November 3, 2005.
RODMAN & RENSHAW, LLC
November 3, 2005
TABLE OF CONTENTS
PROSPECTUS SUPPLEMENT
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Page |
Summary |
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S-1 |
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The Offering |
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S-2 |
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Summary Consolidated Financial Data |
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S-3 |
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Risk Factors |
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S-4 |
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Special Note Regarding Forward Looking Statements |
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S-13 |
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Use of Proceeds |
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S-14 |
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Dilution |
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S-15 |
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Plan of Distribution |
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S-16 |
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Legal Matters |
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S-16 |
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PROSPECTUS |
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Page |
Prospectus Summary |
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3 |
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Risk Factors |
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6 |
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About This Prospectus |
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14 |
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Special Note Regarding Forward Looking Statements |
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15 |
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Use of Proceeds |
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16 |
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Plan of Distribution |
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17 |
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Description of Our Capital Stock |
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20 |
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Dividend Policy |
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22 |
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Legal Matters |
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22 |
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Experts |
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22 |
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Where You Can Find More Information |
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22 |
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Incorporation of Certain Information by Reference |
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23 |
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This prospectus supplement is a supplement to the accompanying prospectus that is also a part
of this document. This prospectus supplement and the accompanying prospectus are part of a shelf
registration statement that we filed with the U.S. Securities and Exchange Commission. Under the
shelf registration process, we may offer from time to time shares of our common stock up to an
aggregate amount of $50,000,000, of which this offering is a part. We previously sold 4,500,000
shares of common stock for gross proceeds of $27.675 million (net proceeds of approximately $25.9
million) and 4,000,000 shares of Common Stock for gross proceeds of $4 million (net proceeds of
approximately $3.6 million). In the accompanying prospectus, we provide you with a general
description of the securities we may offer from time to time under our shelf registration
statement. In this prospectus supplement, we provide you with specific information about the
shares of our common stock that we are selling in this offering. This prospectus supplement and
the accompanying prospectus and the documents incorporated by reference herein and therein include
important information about us, our common stock being offered and other information you should
know before investing. This prospectus supplement also adds, updates, and changes information
contained in the accompanying prospectus. You should read both this prospectus supplement and the
accompanying prospectus, as well as the additional information described under Where You Can Find
More Information, before investing in shares of our common stock.
You should rely only on 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 that is
different. We are offering to sell and seeking offers to buy shares of our common stock only in
jurisdictions where such offers and sales are permitted. The information contained in this
prospectus supplement and the accompanying prospectus is accurate only as of their respective
dates, regardless of the time of delivery of this prospectus supplement and the accompanying
prospectus or of any sale of our common stock.
In this prospectus supplement, we, us, our and our company refer to Novavax, Inc.,
together with its subsidiaries, unless the context otherwise requires.
SUMMARY
This summary highlights selected information contained elsewhere or incorporated by reference
in this prospectus supplement, and may not contain all of the information that is important to you.
For a more complete understanding of this offering, you should read this entire document carefully
and the accompanying prospectus before deciding to invest in our common stock, including the Risk
Factors section below, and those additional documents to which we refer you. See Where You Can
Find More Information on page 22 of the accompanying prospectus.
Our Business
We are an innovative product development company focused on the research, development and
commercialization of products utilizing our proprietary drug delivery and biological technologies
for large and growing markets.
Our drug delivery technologies include micellar nanoparticles (MNPs), proprietary oil and
water nanoemulsions used for the topical delivery of drugs. When applied to the skin in a cream or
lotion formulation, the MNPs deposit the drug in the outermost skin layer, functionally creating a
drug depot. The active drug gradually diffuses into the deeper layers of skin until it reaches the
bloodstream. MNP technology is the basis for the development of the companys FDA-approved
product, ESTRASORB®, the first topical emulsion for estrogen therapy approved for the
treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopausal women.
The company entered into an exclusive North American license and supply agreement with Esprit
Pharma, Inc. on October 18, 2005 for the marketing and sale of ESTRASORB.
We continue to focus our efforts on the development of products utilizing our proprietary
topical MNP drug delivery platform that we believe have a high probability of technical success and
that have a large market potential. As part of our research and development efforts, we intend to
file two Investigational New Drug Applications with the FDA in 2006 for two non-hormone product
candidates.
The companys drug delivery technologies also include Novasomes® and
Sterisomes®. Novasomes are proprietary non-phospholipid liposomes in which drugs can
either be encapsulated or mixed with for delivery by various routes of administration. In
addition, we believe that our Novasome technology may provide a safe and effective adjuvant system
for a variety of vaccines. Sterisomes are the companys proprietary oil-free emulsions that
operate as a drug delivery system comprised predominantly of water. Sterisomes can be used as a
depot delivery system for certain steroidal hormones.
Our vaccine technologies include our lead technology platform based on virus-like particles
(VLPs), which we are using to develop vaccines for pandemic (avian) and seasonal flu. We also
continue to work with government agencies on HIV and SARS vaccines.
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.
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.
S-1
THE OFFERING
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Common stock offered in this offering
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4,186,047 shares |
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Common stock to be outstanding after
this offering
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49,096,261 shares |
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Use of proceeds
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For clinical development of
VLP-based avian and seasonal flu
vaccines; internal research and
development programs; expansion
of and investment in research and
development facilities; and
general working capital. See
Use of Proceeds on page S-14. |
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Nasdaq National Market symbol
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NVAX |
The information above is based on 44,910,214 shares of common stock outstanding as of October
31, 2005. It does not include:
6,796,819 shares of common stock issuable upon the exercise of stock options outstanding as
of October 31, 2005 at a weighted average exercise price of $3.42 per share;
1,513,798 shares of common stock reserved for future awards under our 2005 Stock Incentive
Plan as of October 31, 2005; and
5,213,635 shares of common stock issuable upon the conversion of $29 million aggregate
principal amount of 4.75% convertible notes due July 15, 2009, which includes 108,001 shares
issuable based on the gross proceeds of the offering as a result of anti-dilution provisions in the
notes.
S-2
SUMMARY CONSOLIDATED FINANCIAL DATA
The historical consolidated financial data presented below as of and for each of the periods
ended December 31, 2004, 2003 and 2002 were derived from our audited consolidated financial
statements. The summary consolidated financial data is only a summary and should be read in
conjunction with our consolidated financial statements and related notes that we incorporate by
reference in this prospectus supplement. For copies of the financial information we incorporate by
reference, see Where You Can Find More Information.
Information as of and for the six months ended June 30, 2005 and 2004 has been derived from
our consolidated financial statements, which are unaudited but which in the opinion of management
have been prepared on the same basis as the audited consolidated financial statements and include
all adjustments necessary (consisting of normal recurring adjustments) for a fair presentation of
the results for such periods. The results of operations for the six months ended June 30, 2005 are
not necessarily indicative of the results to be expected for the entire year ending December 31,
2005 or any future period.
(amounts in thousands, except number of shares and per share information)
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For the Six Months Ended |
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For the Years Ended |
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June 30, |
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December 31, |
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2005 |
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2004 |
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2004 |
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2003 |
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2002 |
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(unaudited) |
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(unaudited) |
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Statement of Operations Data: |
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Revenues |
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$ |
3,277 |
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6,225 |
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8,260 |
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11,785 |
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15,005 |
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Loss from operations |
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$ |
(13,642 |
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(12,236 |
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(24,464 |
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(16,054 |
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(21,558 |
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Net loss |
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$ |
(14,602 |
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(12,975 |
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(25,920 |
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(17,273 |
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(22,697 |
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Per share information: |
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Net loss per share |
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$ |
(0.37 |
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(0.37 |
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(0.70 |
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(0.58 |
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(0.93 |
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Weighted average number of
shares outstanding |
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39,533,876 |
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34,750,944 |
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36,926,034 |
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29,852,797 |
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24,433,868 |
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As of June 30, |
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As of December 31, |
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2005 |
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2004 |
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2004 |
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2003 |
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2002 |
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(unaudited) |
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(unaudited) |
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Balance Sheet Data: |
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Total current assets |
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$ |
8,304 |
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22,577 |
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23,937 |
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32,062 |
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6,242 |
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Working capital |
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$ |
2,673 |
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14,466 |
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15,361 |
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27,226 |
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378 |
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Total assets |
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$ |
60,298 |
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74,617 |
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77,993 |
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84,159 |
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57,505 |
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Convertible debt |
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$ |
35,000 |
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40,000 |
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35,000 |
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40,000 |
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40,000 |
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Stockholders equity |
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$ |
18,694 |
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23,338 |
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33,281 |
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35,944 |
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8,073 |
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S-3
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 supplement and
the accompanying prospectus and incorporated by reference before purchasing 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. 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
trading price of our common stock 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 to a product development
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, 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 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, which
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 of 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. |
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. We will either
S-4
need to develop or acquire these resources on our own, which will require substantial funding, time
and effort, or will need to enter into additional collaborative agreements or government contracts
to assist in the development and commercialization of some of these potential products.
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.
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 51 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.
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.
In the near term we will 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
S-5
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 December 31, 2004 was $130.7 million. Our net revenues for the last three years were
$8.3 million in 2004, $11.8 million in 2003 and $15.0 million in 2002. For the six months ended
June 30, 2005 and 2004, our revenues were $3.3 million and $6.2 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 years were $25.9 million in 2004, $17.3 million in 2003 and $22.7 million
in 2002, while they were $14.6 million and $12.9 million for the six months ended June 30, 2005 and
2004, 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. 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.
We have received a comment letter from the Securities and Exchange Commission regarding our
annual report on Form 10-K/A for the fiscal year ended December 31, 2004, and we have yet to
receive confirmation from the Commission that all matters raised in that letter have been resolved
to the satisfaction of the Commission.
The Company received a comment letter from the Commission on July 12, 2005 relating to the
Companys annual report on Form 10-K/A for the fiscal year ended December 31, 2004. The Company
responded to such comment letter on July 26, 2005 and had subsequent telephone conferences with the
Staff of the Commission. Following such telephone conferences, the Company submitted a follow-up
response letter on October 31, 2005.
The Company has not yet received confirmation from the Commission that all matters raised in
its letter dated July 12, 2005 have been resolved to the Commissions satisfaction. The sole
remaining open issue relates to the Companys recording of a $2.5 million intangible asset in
connection with the termination of the Companys business relationship with King Pharmaceuticals,
Inc. in July 2004.
The Commission requested a detailed calculation supporting the $2.5 million intangible asset
recorded, inquired as to why such amount qualified as an intangible asset and requested the
specific authoritative literature the Company used in arriving at its conclusions. In its October
31, 2005 supplemental response letter, the Company clarified its initial response and provided a
detailed explanation of its accounting for the intangible asset. However, the Company has not
received confirmation from the Staff at the Commission that the Companys explanation is sufficient
or acceptable. If the Commission were to determine that the Company improperly recorded the
intangible asset, it may require the Company to restate the relevant portions of its financial
statements. While such a restatement would have no impact on the Companys bottom line, the
announcement of a financial statement restatement would likely negatively impact the price of the
Companys common stock and could materially and adversely affect the Company.
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
S-6
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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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. |
Large and established companies such as Merck & Co., Inc., GlaxoSmithKline PLC, Chiron Corp.
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 and obtaining regulatory approvals
to market such 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 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 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 is to pay the company certain milestone
payments, and Novavax also is entitled to receive a royalty on all future net sales of ESTRASORB.
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. Any loss of Esprit as a partner in the commercialization
of ESTRASORB, dispute over terms of, or decisions regarding the license and supply agreement 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 Novavax in gaining market
S-7
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. Recently, Solvay 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.
In addition, under the supply agreement, Novavax is obligated to supply Esprit with ESTRASORB
through the manufacture of the product at Novavaxs pharmaceutical plant 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.
Currently we are only manufacturing ESTRASORB at our facility in Philadelphia and will
manufacture the product at a loss until production volumes increase or we enter into contract
manufacturing arrangements with third parties to more fully utilize the facilitys capacity, as the
facility is able to accommodate a much greater production schedule than its currently schedule, and
offset the fixed costs related to the manufacturing process and facility. Until we increase
production of ESTRASORB or enter into such contract manufacturing arrangements for sufficient
quantities, the cost of sales percentages will continue to be unusually high and we will continue
to manufacture the product at a loss. In addition, while the Company was successful in negotiating
a substantial reduction in its monthly rent for the facility during 2005, such reductions will
expire in the summer of 2006 and the Company expects lease costs to increase, potentially by a
material amount. Although we are working to design alternative packaging solutions to further
streamline production and lower costs of production, there can be no assurances that such efforts
will result in meaningful cost savings or otherwise be successful.
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. Our product candidate ANDROSORB has completed Phase I human
clinical studies. Additional product candidates are 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 (IND) that explains to the FDA results of the
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 1 studies and larger-scale Phase 2 and 3 human clinical
trials that demonstrate the safety and efficacy of our products to the satisfaction
S-8
of the FDA. Only after these trials are complete can a New Drug Application (NDA) 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 1, are safety and immunogenicity studies performed in a small
number of closely monitored subjects. Phase 2 studies are dose-ranging studies and may enroll
hundreds of subjects. Finally, Phase 3 trials typically enroll thousands of individuals and
provide the critical documentation of effectiveness and important additional safety data required
for licensing.
If successful, the completion of all three phases of clinical development can be followed by
the submission of a Biologics License Application (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 4 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, and 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,
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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 |
S-9
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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.
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.
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 2004, our common stock traded in a range from $2.88 to $6.99. Between January 1, 2005
and October 31, 2005, our common stock traded in a range from $0.70 to $6.01. It is likely that
the price of our common stock will fluctuate in the future. The market prices of securities of
small-capitalization, specialty 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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our ability to obtain government contracts to develop vaccines and other biological
products and technologies; |
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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; 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 this Risk Factors section could
have a material and adverse impact on the market price of our common stock.
S-10
Our substantial indebtedness could adversely affect our cash flow and prevent us from
fulfilling our obligations.
As of October 31, 2005, we had approximately $29.9 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
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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
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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.
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
S-11
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, and have guaranteed a brokerage margin loan
for one of these 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 December 31, 2004, accrued interest receivable related to
the borrowing was $209,000. In addition, in 2002 we executed a conditional guaranty of a brokerage
margin account for a director in the amount of $500,000. 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 THIS OFFERING
Management will have broad discretion as to the use of proceeds from this offering, and we may
not use the proceeds effectively.
We have not designated the amount of net proceeds we will use for any particular purpose.
Accordingly, our management will have broad discretion as to the application of the net proceeds
and could use them for purposes other than those contemplated at the time of this offering. Our
stockholders may not agree with the manner in which our management chooses to allocate and spend
the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may
not increase our market value or make us profitable.
Because the total price you will pay for your shares in the offering will be much greater than
the value of our assets after subtracting our liabilities, the value of your investment in our
common stock will be diluted.
If you purchase our common stock in this offering, the price you will pay for our common stock
will be much greater than the book value per share of our outstanding common stock after the
offering. In addition, the total amount of our capital will be less than it would have been had you
and all of the existing stockholders and optionees paid the same amount per share for our common
stock. Accordingly, you will suffer immediate and substantial dilution of your investment. In the
past, we have issued options and warrants to buy our common stock at prices below the offering
price. You will experience further dilution to the extent that additional shares of our common
stock are issued upon the exercise of outstanding stock options and other purchase rights. See
Dilution for a detailed calculation of the dilution that will result from this offering.
The issuance of shares of our common stock in connection with this offering will cause
additional shares of common stock to be issuable upon conversion of certain outstanding convertible
notes of the company.
Assuming that we issue an aggregate of 4,186,047 shares of our common stock at a public
offering price of $4.30 per share, an additional 108,001 shares of common stock will be issuable
upon the conversion of $29 million aggregate principal amount of 4.75% convertible notes that are
due July 15, 2009. Accordingly, you will suffer additional dilution of your investment. See
Dilution for a detailed calculation of the dilution that will result from this offering.
S-12
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus supplement, the accompanying prospectus and the documents
incorporated by reference herein and 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 to management, 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 product sales, future results of operations, 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 supplement,
the accompanying prospectus and the documents incorporated by reference and include, among other
things, the following: general economic and business conditions; competition; unexpected changes in
technologies and technological advances; ability to obtain rights to technology; ability to obtain
and enforce patents; ability to commercialize and manufacture products; ability to maintain
commercial-scale manufacturing capabilities; ability to enter into future collaborations with
industry partners; results of clinical studies; progress of research and development activities;
business abilities and judgment of personnel; availability of qualified personnel; changes in, or
failure to comply with, governmental regulations; ability to obtain adequate financing in the
future; and other factors referenced in this prospectus supplement, the accompanying prospectus and
the documents incorporated by reference herein and therein.
S-13
USE OF PROCEEDS
After deducting the placement agents fee and estimated offering expenses of this offering, we
will receive net proceeds from this offering of approximately $17,025,000.
We will retain broad discretion over the use of the net proceeds from the sale of our common
stock. We currently intend to use the net proceeds from this offering for general corporate
purposes, including but not limited to:
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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 cGMP and GLP rules and regulations; and |
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general working capital. |
We have not determined the amounts we plan to spend on any of the areas listed above or the
timing of these 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. As a result, our management will have broad
discretion to allocate the net proceeds from this offering. Pending application of the net proceeds
as described above, we intend to invest these net proceeds in short-term, interest-bearing,
investment-grade securities.
S-14
DILUTION
Our net tangible book value at June 30, 2005 was $ 18.7 million, or $0.47 per share of common
stock. Net tangible book value per share represents total tangible assets less total liabilities
divided by the number of outstanding shares of our common stock on June 30, 2005. Assuming that we
issue an aggregate of 4,186,047 shares of our common stock at a public offering price of $4.30 per
share, with estimated net proceeds to us (after assumed fees and expenses) of $17,025,000, our pro
forma net tangible book value at June 30, 2005 would have been $35.725 million, or $0.82 per share.
This represents an immediate increase in the tangible book value of $0.35 per share to our
existing stockholders and an immediate dilution of $3.48 per share to new investors purchasing
common stock in this offering, as illustrated in the following table:
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Public offering price per share |
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0.82 |
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3.48 |
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The computations in the table above assume no exercise of any outstanding stock options or
warrants or the conversion of any convertible notes after June 30, 2005. At October 31, 2005, there
were options outstanding to purchase a total of 6,796,819 shares of our common stock at a weighted
average exercise price of $3.42 per share. If any of these options are exercised, there will be
further dilution to new investors. In addition, assuming that we issue an aggregate of 4,186,047
shares of our common stock at a public offering price of $4.30 per share, an additional 108,001
shares of common stock shall be issuable upon the conversion of $29 million aggregate principal
amount of 4.75% convertible notes due July 15, 2009.
S-15
PLAN OF DISTRIBUTION
We are offering the shares of our common stock through a placement agent. Subject to the terms
and conditions contained in an agreement dated November 1, 2005, Rodman & Renshaw, LLC has agreed
to act as the placement agent for the sale of up to 4,186,047 shares of our common stock. The
placement agent is not purchasing or selling any shares by this prospectus supplement or
accompanying prospectus, nor is it required to arrange the purchase or sale of any specific number
or dollar amount of shares.
The securities purchase agreement provides that the obligations of the investors in the
offering are subject to certain conditions precedent, including the absence of any material adverse
change in our business and the receipt of certain opinions, letters and certificates from Novavax
and our counsel.
Confirmations and definitive prospectuses will be distributed to all investors who agree to
purchase shares of our common stock, informing investors of the closing date as to such shares. We
currently anticipate that closing of the sale of 4,186,047 shares of common stock will take place
on or about November 3, 2005. Investors will also be informed of the date and manner in which they
must transmit the purchase price for their shares.
On the scheduled closing date, the following will occur:
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we will receive funds in the amount of the aggregate purchase price directly from
investors; and |
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we will pay the placement agent fee in accordance with the terms of our
agreement with Rodman & Renshaw, LLC, and reimbursement of expenses not to exceed
$25,000. |
We will pay the placement agent a commission equal to five percent (5%) of the gross proceeds
of the sale of shares of common stock in the offering. In no event will the total amount of
compensation paid to the placement agent and other securities brokers and dealers upon completion
of this offering exceed five percent (5%) of the maximum gross proceeds of the offering. The
estimated offering expenses payable by us, in addition to the placement agents fee, are
approximately $75,000, which includes legal, accounting and printing costs and various other fees
associated with registering and listing the shares of common stock. After deducting certain fees
due to the placement agent and our estimated offering expenses, we expect the net proceeds from
this offering to be up to approximately $17,025,000.
We have agreed to indemnify the placement agent and the purchasers against certain
liabilities, including liabilities under the Securities Act of 1933, as amended. We may also be
required to contribute to payments the placement agent may be required to make in respect of such
liabilities.
The agreement with Rodman & Renshaw, LLC and the form of securities purchase agreement with
the investors are included as exhibits to our Current Report on Form 8-K that will be filed with
the Securities and Exchange Commission in connection with the consummation of this offering.
The transfer agent for our common stock is Computershare Limited.
Our common stock is traded on the Nasdaq National Market under the symbol NVAX.
LEGAL MATTERS
Certain legal matters with respect to the shares of common stock offered hereby have been
passed upon by White White & Van Etten LLP in Cambridge, Massachusetts. David A. White, a partner
of such firm, owns 30,000 shares of our common stock. Feldman Weinstein LLP in New York, New York
is acting as counsel for the placement agent.
S-16
The information in this prospectus is not complete and may be changed. We may not sell these
securities until the registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities and it is not soliciting an
offer to buy these securities in any state where the offer or sale is not permitted.
PROSPECTUS
Subject to Completion, Dated November 12, 2003
$50,000,000
Novavax, Inc.
COMMON STOCK
We may sell from time to time shares of our common stock, par value $.01 per share, in
one or more offerings with a maximum aggregate offering price of $50,000,000. This means:
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we will provide a prospectus supplement each time we issue common stock; and |
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the prospectus supplement will inform you about the specific terms of that offering and
may also add, update or modify information contained in this document. |
Our common stock is traded on the Nasdaq National Market under the symbol NVAX. On August 8,
2003, the closing price of our common stock as reported on the Nasdaq National Market was $5.66 per
share.
Our principal offices are located at 8320 Guilford Road, Columbia, Maryland 21046. Our
telephone number is (301) 854-3900.
Investing in our common stock involves a high degree of risk. See RISK FACTORS
beginning on page 6.
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 _________, 2003.
TABLE OF CONTENTS
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Prospectus Summary |
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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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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. We have not authorized anyone to provide you with information different from that
contained in this prospectus or any prospectus supplement. We are offering to sell our common
stock, and seeking offers to buy, only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus is accurate only as of the date of this prospectus,
regardless of the time of delivery of this prospectus or any sale of our common stock.
In this prospectus, the Company, we, us and our refer to Novavax, Inc., together with
its subsidiaries, unless the context otherwise requires.
PROSPECTUS SUMMARY
This summary highlights selected information contained elsewhere or incorporated by reference
in this prospectus, and may not contain all of the information that is important to you. For a more
complete understanding of this offering, you should read this entire document carefully before
deciding to invest in our common stock, including the Risk Factors section below, and those
additional documents to which we refer you. See Where You Can Find More Information on page 22.
Our Business
Novavax is a fully-integrated specialty pharmaceutical company focused on the research,
development and commercialization of products utilizing our proprietary drug delivery and vaccine
technologies for large and growing markets, concentrating on the areas of womens health and
infectious diseases. Our lead product candidate, ESTRASORB, is the first topical emulsion for
estrogen replacement therapy for which a New Drug Application has been accepted for review by the
Food and Drug Administration. The NDA for ESTRASORB was submitted in June 2001 and was accepted for
review in August 2001. In April 2002, we were informed by the FDA that the agency had completed its
review of the NDA for ESTRASORB. At that time, the agency did not raise any issues regarding the
efficacy or safety of ESTRASORB, but did request additional information with respect to the
Chemistry, Manufacturing and Controls section of the filing. We determined that the most
advantageous approach to resolving the outstanding CMC questions was to voluntarily withdraw the
NDA and resubmit it once all of the responses to the CMC questions had been prepared. In September
2002, we re-submitted the NDA, which was accepted for review by the FDA in November 2002. In June
2003, the agency informed us that it would need additional time for a full review of our Estradiol
Partner Transfer Study Report submitted in May of this year. Under the Prescription Drug User Fee
Act the statutory minimum extension time is 90 days, which thus results in a new goal date for a
decision on the approvability of ESTRASORB of no later than October 10, 2003. We are seeking FDA
approval of ESTRASORB for the reduction of hot flushes in menopausal women and, if approved, we
believe ESTRASORB will be competitively positioned to address the estimated $1.8 billion estrogen
replacement therapy market in the United States.
Our micellar nanoparticle technology involves the use of our patented oil and water emulsions
that we believe can be used as vehicles for the topical delivery of a wide variety of drugs and
other therapeutic products, including hormones. We believe that our technology represents the first
time that ethanol soluble hormones, such as estrogen and testosterone, have been encapsulated and
delivered topically. In addition to ESTRASORB, our product candidates using these technologies
include ANDROSORB, a topical testosterone emulsion that has completed two Phase I clinical trials;
TESTESTRASORB, a topical estrogen and testosterone emulsion; PROGESTSORB NE, a topical progestin
emulsion; and PROESTRASORB, a topical estrogen and progestin emulsion. Other drug delivery
technologies, such as our Novasome® and Sterisome® technologies, are being
utilized to develop other products. Novasomes are used as adjuvants to enhance vaccine
effectiveness. Sterisomes are being used for, among other things, subcutaneous injections that can
deliver long-acting drug effects. We also conduct research and development on preventative vaccines
and proteins for a variety of infectious diseases and immunotherapies.
Over the past three years we have entered into a co-promotion agreement with King
Pharmaceuticals, Inc. for the promotion and marketing of ESTRASORB and ANDROSORB within the United
States and Puerto Rico, and we have licensed to King the right to sell these products outside the
United States. Our relationship with King has the potential to provide us with broader womens
health market coverage for ESTRASORB and ANDROSORB. Under the terms of our co-promotion agreement
with King, we will record all of the product sales, returns and allowances, and cost of sales for
ESTRASORB and ANDROSORB in the United States and Puerto Rico. The resultant gross margin will be
shared equally with King and the payment to King will be recorded as a selling and marketing
expense on our statement of operations. In addition, following product approval by the FDA, both
parties will share equally in approved marketing expenses for the products. All direct marketing
expenses will be recorded by us, for which King will reimburse us fifty percent. We received
licensing fees of $3.0 million and milestone payments totaling $5.0 million from King upon the
submission to the FDA and acceptance for review of the ESTRASORB NDA. We have also received from
King $20.0 million in December 2000, $10.0 million in September 2001 and $10.0 million in June
2002, in the form of convertible note financings.
3
We currently market, sell and distribute a line of prescription pharmaceuticals through our 64
person sales force that has extensive experience selling to obstetricians, gynecologists, managed
care organizations, wholesalers and retail pharmacies throughout the United States. In 2002, these
products generated revenues of $12.8 million. If we receive marketing approval from the FDA, we
expect to sell ESTRASORB through both our sales force and Kings sales force. We intend to
manufacture ESTRASORB for commercial sale in our dedicated, state-of-the-art, 24,000 square foot
facility in Philadelphia, Pennsylvania, which was substantially completed in December 2002.
Our principal executive offices are located at 8320 Guilford Road, Columbia, MD 21046. Our
telephone number is (301) 854-3900. We are incorporated under
the laws of the State of Delaware.
4
1
SUMMARY CONSOLIDATED FINANCIAL DATA
The historical consolidated financial data presented below as of and for each of the periods
ended December 31, 2002, 2001 and 2000 were derived from our audited consolidated financial
statements. The summary consolidated financial data is only a summary and should be read in
conjunction with our consolidated financial statements and related notes that we incorporate by
reference in this prospectus. For copies of the financial information we incorporate by reference,
see Where You Can Find More Information on page 22.
Information as of June 30, 2003 and for the six months ended June 30, 2003 and 2002 has been
derived from our consolidated financial statements, which are unaudited but which in the opinion of
management have been prepared on the same basis as the audited consolidated financial statements
and include all adjustments necessary (consisting of normal recurring adjustments) for a fair
presentation of the results for such periods. The results of operations for the quarter ended June
30, 2003 are not necessarily indicative of the results to be expected for the entire year ending
December 31, 2003 or any future period.
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(amounts in thousands, except number of shares and per share information) |
|
|
|
for the six months ended |
|
|
for the years ended |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2003 |
|
|
2002 |
|
|
2002 |
|
|
2001 |
|
|
2000 |
|
|
1999 |
|
|
1998 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
(restated) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement
of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
3,469 |
|
|
$ |
10,177 |
|
|
$ |
15,005 |
|
|
$ |
24,066 |
|
|
$ |
2,475 |
|
|
$ |
1,181 |
|
|
$ |
681 |
|
Loss from operations |
|
|
(10,033 |
) |
|
|
(10,990 |
) |
|
|
(21,558 |
) |
|
|
(9,255 |
) |
|
|
(12,742 |
) |
|
|
(4,566 |
) |
|
|
(5,152 |
) |
Net loss |
|
|
(10,830 |
) |
|
|
(11,500 |
) |
|
|
(22,697 |
) |
|
|
(9,745 |
) |
|
|
(12,191 |
) |
|
|
(4,506 |
) |
|
|
(4,817 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.38 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.93 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.39 |
) |
Weighted average number of
shares outstanding |
|
|
28,489,651 |
|
|
|
24,209,198 |
|
|
|
24,433,868 |
|
|
|
22,670,274 |
|
|
|
19,015,719 |
|
|
|
14,511,081 |
|
|
|
12,428,426 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for the six months ended |
|
|
|
|
|
|
As of June 30, |
|
|
As of December 31, |
|
|
|
2003 |
|
|
2002 |
|
|
2002 |
|
|
2001 |
|
|
2000 |
|
|
1999 |
|
|
1998 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(restated) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
$ |
12,837 |
|
|
$ |
21,100 |
|
|
$ |
6,242 |
|
|
$ |
25,027 |
|
|
$ |
17,036 |
|
|
$ |
1,143 |
|
|
$ |
1,207 |
|
Working capital |
|
|
8,646 |
|
|
|
13,326 |
|
|
|
378 |
|
|
|
18,030 |
|
|
|
12,331 |
|
|
|
(480 |
) |
|
|
349 |
|
Total assets |
|
|
63,908 |
|
|
|
69,387 |
|
|
|
57,505 |
|
|
|
67,115 |
|
|
|
56,529 |
|
|
|
4,463 |
|
|
|
3,819 |
|
Convertible debt |
|
|
40,000 |
|
|
|
40,000 |
|
|
|
40,000 |
|
|
|
30,000 |
|
|
|
20,000 |
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
16,122 |
|
|
|
19,113 |
|
|
|
8,073 |
|
|
|
27,493 |
|
|
|
31,824 |
|
|
|
2,840 |
|
|
|
2,961 |
|
|
5
RISK FACTORS
You should carefully read the following risk factors in addition to the remainder of this
prospectus before purchasing any shares of our common stock. Some of the following risks relate
principally to our business and the industry in which we operate. Other risks relate principally to
the securities market and ownership of our common stock. If any of the following risks occur, our
business, financial condition and/or operating results could be adversely affected. In that case,
the trading price of our common stock could decline, and you could lose all or part of your
investment.
Our success is heavily dependent on FDA approval and market acceptance of ESTRASORB.
Our New Drug Application for ESTRASORB was accepted for review by the FDA in November 2002.
There is no guarantee that the FDA will approve our application and allow us to begin selling
ESTRASORB in the United States. If we do not receive FDA approval of our application, our inability
to sell ESTRASORB in the United States would have a significant negative effect on our business and
results of operations. Even if ESTRASORB is approved by the FDA, there is no guarantee that we and
King Pharmaceuticals, Inc., our marketing partner for ESTRASORB, will be able to successfully
commercialize ESTRASORB. Many factors could negatively affect our ability to successfully
commercialize ESTRASORB, including:
|
|
|
a failure or delay in ESTRASORB gaining a meaningful share of the estrogen replacement
therapy market, which currently is dominated by Premarin®, an oral estrogen
tablet sold by Wyeth, and estrogen patches sold by several companies including Novartis
Pharma AG, Berlex Laboratories, Inc. and Forest Pharmaceuticals, Inc.; |
|
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|
|
our inability to effectively promote and sell ESTRASORB with King in the United States,
or Kings inability to do so in the rest of the world; |
|
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|
delays in the manufacture of ESTRASORB in commercial quantities; and |
|
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|
|
the inability to obtain coverage and favorable reimbursement rates for ESTRASORB from
insurers and other third party payors. |
We will face substantial competition in connection with the sale of ESTRASORB and our other
product candidates.
We compete with numerous other companies worldwide that have developed or are developing
products that compete or may compete with our product candidates. These competitors include both
large and small pharmaceutical companies, biotechnology firms, universities and other research
institutions. We may not succeed in developing technologies and products that are more effective
than those being developed by our competitors.
Many large companies currently produce and sell estrogen products for clinical indications
identical to those that we seek for ESTRASORB. In the oral product segment of the estrogen
replacement therapy market, which accounts for approximately 74% of the market according to 2002
IMS Health Incorporated data, Wyeth commits significant resources to the sale and marketing of its
product, Premarin®, in order to maintain its market leadership position. Warner-Chillcot
also competes in the branded oral product segment with its product, Estrace®. In
addition, ESTRASORB will compete with products produced and sold by generic manufacturers in the
oral product segment of the market, such as Watson Pharmaceutical, Inc.s generic product,
Estropipate®. In the patch segment of the market, which according to IMS Health accounts
for approximately 15% of the estrogen replacement therapy market, several companies market
transdermal estrogen patches with which ESTRASORB will compete, if approved. For example, Novartis
Pharma AG currently markets and sells its Vivelle® and Estraderm® patches and
Berlex Laboratories, Inc. and Forest Pharmaceuticals Inc. co-promote the Climara®
transdermal patch. Several companies also currently market ethanol-based estrogen gels and
ointments outside the United States. For example, Schering Canada sells its estrogen gel,
Estrogel®, in Canada. These and other products sold by our competitors have all been
approved for sale and have achieved some degree of market penetration. If ESTRASORB is approved for
sale in the Untied States, it will compete for market share with these products and we cannot
guarantee that, together
6
with King, we will be able to effectively promote ESTRASORB against these competitive
products. In order to effectively compete, we may make substantial investments in sales and
marketing. Many of these products are sold by companies with greater resources than we have and
there is no assurance that we will be successful in gaining significant market share for ESTRASORB
or in earning a return on that investment.
Our technologies and products may be rendered obsolete or noncompetitive as a result of
products introduced by competitors. Most of our competitors have substantially greater financial
and technical resources, production and marketing capabilities, and related experience than we do.
The greater resources, capabilities and experience of our competitors may enable them to develop,
manufacture and market their products more successfully and at a lower cost than we can. In
addition, many of our competitors have significantly greater experience than we do in conducting
preclinical testing and clinical trials of human pharmaceuticals and obtaining regulatory approvals
to market such products. Accordingly, our competitors may succeed in obtaining FDA approval for
products more rapidly than we will, which may give them an advantage over us in achieving market
acceptance of their products.
We would need additional capital to grow ad operate our business in the event we were unable
to raise capital in this offering, and we are uncertain about obtaining future financing.
We estimate that our existing cash resources will be sufficient to finance our operations at
current and projected levels of development and general corporate activity for the next 5 to 7
months. We cannot be certain that we will be able to generate revenues from product sales in the
near term or at all sufficient to fund our operations. If w were unable to raise capital in this
offering, we would require additional funds to continue our research and development, commence
future preclinical and clinical trials, seek regulatory approvals, establish commercial-scale
manufacturing capabilities, and market our products. We may seek additional funds through public or
private equity or debt financings, collaborative arrangements with pharmaceutical companies 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 we may need to continue our
current and anticipated operations, we may be required to delay significantly, reduce the scope of,
or eliminate one or more of, our research or development programs. If that is the case, we will
seek other alternatives 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.
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 June 30, 2003 was $98.4 million. Our revenues for the last three years were $15.0
million in 2002, $24.0 million in 2001 and $2.5 million in 2000. For the six months ended June 30,
2003 and 2002, our revenues were $3.5 million and $10.2 million, respectively. Sales of products
that we acquired as a result of our acquisition of Fielding Pharmaceutical Company in 2000 have
generated modest revenues, but based on our current business plan these revenues will not be
sufficient to offset our expenses in the future. We cannot be certain when or if we will generate
substantial revenues from the sale of ESTRASORB. We have received a very 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
years were $22.7 million in 2002, $9.7 million in 2001 and $12.1 million in 2000, while they were
$10.8 million and $11.5 million for the six months ended June 30, 2003 and 2002, respectively. Our
losses have resulted from research and development expenses, pre-launch sales and marketing
expenses in the anticipation of FDA approval for ESTRASORB, protection of our intellectual
property, and other general operating expenses. Our annual losses may increase depending on the
timing of the FDA approval and launch of ESTRASORB as we expand our manufacturing capacity, sales
and marketing capabilities and conduct additional and larger clinical trials for other product
candidates. Therefore, we expect our cumulative operating loss to increase until such time, if
ever, as product sales, licensing fees and royalty payments 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 intend to allocate a significant portion of our sales forces time to the product launch of
ESTRASORB, if and when it is approved by the FDA. Accordingly, the sales of our other womens
health products could be
7
adversely affected by the efforts we allocate to the ESTRASORB product launch. The costs of
maintaining our own sales force to market our current products and ESTRASORB, if approved, may in
the future exceed product revenues. If we continue to market ESTRASORB or future products directly,
significant additional expenditures and management resources may be required to increase the size
of our internal sales force.
Our sales and marketing plan for ESTRASORB depends in large part on the success of our
relationship with King.
We have entered into a co-promotion agreement with King for the marketing and promotion of
ESTRASORB in the United States using our sales and marketing personnel and Kings sales and
marketing personnel. We have also granted King exclusive rights to promote, market and distribute
ESTRASORB outside the United States. In return, we received certain milestone payments and the
agreement to pay potential future milestone payments and licensing fees and royalties on future
sales. While our agreements with King give us some limited protections with respect to Kings
marketing and sales efforts and, we believe, create financial incentives for King consistent with
our own, we cannot control the amount and timing of marketing efforts that King devotes to
ESTRASORB or make any assurances that our and Kings co-promotion of ESTRASORB in the United States
and Kings marketing of ESTRASORB in the rest of the world will be successful.
Our success in marketing other potential future products will also depend in large part on our
relationship with King. Our co-promotion agreement with King also provides for co-promotion in the
United States with King of our product candidate ANDROSORB. If this product is approved for
marketing by the FDA, King has an exclusive worldwide license, except in the United States, to
market this future product. Under our co-promotion agreement, King has the right to co-promote
certain future hormone replacement therapy products in the field of womens health. In the future,
we might enter into other licensing or co-promotion arrangements with King or other third parties
for the marketing and sale of other future products. Any revenues we receive from sales of
ANDROSORB and other future products will depend in large part on the terms of these agreements and
the efforts of King and any other third-party marketing partners.
Our agreements with King reduce the likelihood that we could be acquired by another company.
Our co-promotion agreement and license agreement with King for the marketing of ESTRASORB and
ANDROSORB contain several provisions that would take effect upon a change of control of the
Company. One provision allows King several options in the event of a change in control of Novavax
including (i) terminating our right to co-promote King products, (ii) terminating our rights to
promote ESTRASORB and ANDROSORB and certain other hormone therapies for women, or (iii) requiring
Novavax to assign and transfer to King all related rights of ownership for ESTRASORB and ANDROSORB
and certain other hormone replacement therapies for women and license to King on an exclusive and
perpetual basis all intellectual property rights and know-how. If King chooses to exercise its
rights under either clause (ii) or (iii) above, King will pay us royalties on net sales of the
products. In addition, King will pay us for the cost of manufacturing, plus a markup consistent
with the terms of the license agreement for the handling costs. King could also require that we
redeem the outstanding promissory notes, currently in the amount of $40.0 million, at 101% of the
outstanding principal and accrued interest. These provisions may have the effect of making us less
attractive as an acquisition candidate.
We need additional manufacturing capability to commercialize our products.
We do not have any experience with the large capacity manufacturing required for commercial
sale of a product. Although we have had the ability to produce the limited quantities of products
needed to support our current research and development program and clinical trials (including
utilizing contract manufacturing organizations), we will need more production capacity for larger,
later-stage clinical studies and commercial sales. Our potential products may be too difficult or
costly to manufacture on a large scale, to develop into commercially viable products or to market.
We have validated our manufacturing methods for ESTRASORB, which has been produced in 100-kilo
size batches. Such validation is required under FDA guidelines, and we have received preliminary
FDA approval of these methods. We currently manufacture ESTRASORB at a facility of Cardinal Health,
Inc. in Philadelphia, Pennsylvania. In February 2002, we entered into an agreement with Cardinal
Health to lease approximately 24,000
8
square feet of space within their facility. Under the terms of this agreement, Cardinal Health
will also provide packaging services for the product we manufacture in their facility. We have
substantially completed the build out of the facility to meet our requirements and have installed
manufacturing equipment at this facility with the capacity required for commercial production of
ESTRASORB. Now that this new equipment is installed, we need to validate that the ESTRASORB made
using this new equipment is identical to that used in our clinical trials. If we are unable to make
ESTRASORB on a commercial scale or are delayed in validating the product manufactured with our new
equipment, the commercialization of ESTRASORB would be delayed.
In the near term, we will be manufacturing ESTRASORB only in the Philadelphia facility. If
ESTRASORB is approved by the FDA, we plan to qualify at least one additional site for the
manufacture of ESTRASORB. If we are unable to utilize the Philadelphia facility to manufacture
ESTRASORB prior to our qualification of a second site, however, we would not have immediate access
to ESTRASORB and would be required to reestablish our validation process at a different facility
that would cause us to lose sales of ESTRASORB and would adversely affect our business.
We currently utilize third party contract manufacturers to manufacture our other products. Any
contract manufacturers facility that we may use, including the Cardinal Health facility, must
adhere to the FDAs regulations on current good manufacturing practices, which are enforced by the
FDA through its facilities inspection program. These facilities are subject to periodic inspection
by the FDA. The manufacture of products at these facilities will be subject to strict quality
control testing and record-keeping requirements. 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.
If we decide to manufacture our own products, we will need to acquire additional manufacturing
facilities and to improve our manufacturing technology. Establishing additional manufacturing
facilities will require us to spend substantial funds, hire and retain a significant number of
additional personnel and comply with extensive regulations applicable to such facilities here and
abroad, including the current good laboratory practices and good manufacturing practices required
by the FDA. If we elect to or need to manufacture our own products, we risk the possibility that we
may not be able to do so in a timely fashion at acceptable quality and prices or in compliance with
good laboratory practices and good manufacturing practices.
We have not completed the development of many of our products and we may not succeed in
obtaining the FDA approval necessary to sell any additional products.
The development, manufacture and marketing of our pharmaceutical 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. Only a few of our products have been approved for sale and our
application to sell ESTRASORB in the United States is currently being reviewed by the FDA. Our
product candidate, ANDROSORB, has completed two Phase I human clinical studies. Our other product
candidates are in preclinical laboratory or animal studies. Before applying for FDA approval to
market any additional product candidates, we must conduct larger-scale Phase II and III human
clinical trials that demonstrate the safety and efficacy of our products to the satisfaction of the
FDA or other regulatory authorities. These processes are expensive and can take many years to
complete. We may not be able to demonstrate the safety and efficacy of our products to the
satisfaction of the FDA or other regulatory authorities. We may also be required to demonstrate
that our proposed products represent an improved form of treatment over existing therapies and we
may be unable to do so without conducting further clinical studies.
We may fail to obtain regulatory approval for our products on a timely basis. 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:
|
|
|
the rate of patient enrollment, 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 |
9
|
|
|
the protocol; |
|
|
|
|
institutional review board approval of the protocol and the informed consent form; |
|
|
|
|
prior regulatory agency review and approval; |
|
|
|
|
analysis of data obtained from preclinical and clinical activities that are susceptible
to varying interpretations, which interpretations could delay, limit or prevent regulatory
approval; |
|
|
|
|
changes in the policies of regulatory authorities for drug approval during the period of
product development; and |
|
|
|
|
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. Also, the results of our clinical trials may not be
consistent with the results obtained in preclinical studies or the results obtained in later phases
of clinical trials may not be consistent with those obtained in earlier phases. A number of
companies in the specialty pharmaceutical 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. Furthermore, even if a product of ours gains regulatory approval, the
product and the manufacturer of the product will be subject to continuing regulatory review. We 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.
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success will, in large part, depend on our ability to maintain the proprietary nature of
our technology and other trade secrets. To do so, we must prosecute and maintain existing patents,
obtain new patents and pursue trade secret protection. We also must operate without infringing the
proprietary rights of third parties or letting third parties infringe our rights. We currently have
55 U.S. patents and approximately 150 foreign patents and patent applications covering our
technologies. We recently filed eight new patent applications in the US and worldwide directed
towards innovative discoveries made in the field of human Papillomavirus virus-like particles.
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 United States Patent and Trademark Office or enforced by the federal
courts. Therefore, we do not know whether our 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 may 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 product candidates,
including composition, methods of manufacture and use, our patents do not provide us with complete
protection against the development of competing products. For example, our patents do not prohibit
third parties from developing and selling products for estrogen replacement therapy that deliver
estrogen through a topical emulsion, ointment or similar medium.
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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.
Health care insurers and other payors may not pay for our products or may impose limits on
reimbursement.
Our ability to commercialize ESTRASORB and our 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 ESTRASORB or other products in the future to market, we cannot be
assured that third-party payors will pay for ESTRASORB or will establish and maintain price levels
sufficient for realization of an appropriate return on our investment in product development. For
example, ESTRASORB, if approved for commercial sale in the United States, would be sold as an
outpatient prescription drug. Medicare does not cover the costs of most outpatient prescription
drugs. We expect that ESTRASORB will be treated the same as other estrogen replacement therapy
products with respect to government and third-party payor reimbursement. However, we cannot be
assured that ESTRASORB will receive similar reimbursement treatment.
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 sometimes the cost of the
drug in comparison to alternative products. We cannot be assured 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 $18.0 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. We cannot be assured 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 may be time-consuming and expensive and may damage our
reputation in the marketplace.
We have made loans to certain of our directors, and have guaranteed a brokerage margin loan
for one of these directors that could have a negative impact on our stock price.
In 2002, pursuant to our Stock Option Plan, we approved the payment of the exercise price of
options by two directors through the delivery of full recourse interest bearing promissory notes,
in the aggregate amount of approximately $1.5 million, secured by a pledge of the underlying
shares. In addition, in 2002 we executed a conditional guaranty of a brokerage margin account for a
director in the amount of $500,000. 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.
The price of our common stock has been, and may continue to be, volatile.
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Historically, the market price of our common stock has fluctuated over a wide range. In fiscal
2002, our common stock traded in a range from a low of $1.59 to a high of $14.00. In fiscal 2003,
our common stock has traded in a range from a low of $2.52 to a high of $6.87 as of August 8, 2003.
It is likely that the price of our common stock will fluctuate in the future. The market prices of
securities of small capitalization specialty pharmaceutical companies, including ours, from time to
time experience significant price and volume fluctuations unrelated to the operating performance of
particular companies. In particular, over the next year, 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 our
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our ability to obtain financing; and |
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sales of our products, particularly ESTRASORB, if it is approved for sale. |
In addition, the occurrence of any of the risks described in this Risk Factors section could have
a dramatic and adverse impact on the market price of our common stock.
Our substantial debt could adversely affect our cash flow and prevent us from fulfilling our
obligations.
We currently have $41.6 million of outstanding debt. Our substantial amount of debt could have
important consequences to you. For example, it:
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could increase our vulnerability to general adverse economic and industry conditions; |
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will require us to dedicate a substantial portion of our cash flow from operations to
service payments on our debt, 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 pharmaceutical industry, which may place us at a competitive disadvantage compared with
competitors that have less debt; and |
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could limit our ability to borrow additional funds, even when necessary to maintain
adequate liquidity. |
We may incur additional debt for various reasons, which, if over a certain amount, must be
approved by King. Any such additional debt could be senior to the common stock being offered in
this offering and would increase the risks associated with our substantial leverage.
Our inability to recruit and retain members of our management team and key personnel could
have a material adverse effect on our business.
Our future success will depend in part on our ability to attract and retain highly skilled
employees, particularly those in management, sales, regulatory, manufacturing and technical
positions. The loss of services of members of our management team could adversely affect our
business and impede or delay achievement of our corporate mission. Furthermore, recruiting and
retaining qualified scientific and other key employees will be critical to our success, and
competition for such employees in our targeted industry and in our geographic regions is intense.
In addition, many of the companies with which we compete for highly qualified personnel have
greater financial and other resources than we do. We may be unable to attract and retain key
employees on acceptable terms given the level and nature of such competition.
Anti-takeover provisions could make a third-party acquisition of us more difficult.
In 2002, we adopted a Shareholder Rights Plan that provided for the issuance of rights to
purchase shares of
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Series D Junior Participating Preferred Stock of the Company. Under the plan, we distributed
one preferred share purchase right for each outstanding share of common stock. Each purchase right
entitles the holder to purchase from the Company one one-thousandth (1/1000th) of a preferred share
at a price of $40 per one one-thousandth (1/1,000th) of a share, subject to adjustment. The rights
become exercisable, with certain exceptions, ten business days after any party, without prior
approval of our Board of Directors, acquires or announces an offer to acquire beneficial ownership
of 15% or more of the Companys common stock. In the event that any party acquires 15% or more of
the Companys common stock, the Company enters into a merger or other business combination, or if a
substantial portion of the Companys assets is sold after the time that the rights become
exercisable, the rights provide that the holder will receive, upon exercise, shares of the common
stock of the surviving or acquiring company, as applicable, having a market value of twice the
exercise price of the right. The Shareholder Rights Plan may discourage or prevent certain types of
transactions involving an actual or potential change in control, which transactions may be
beneficial to our shareholders, by causing substantial dilution to a party that attempts to acquire
us on terms not approved by our Board.
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ABOUT THIS PROSPECTUS
This prospectus is part of a shelf registration statement that we filed with the Securities
and Exchange Commission (the SEC). By using a shelf registration statement, we may, from time to
time, sell shares of our common stock in one or more offerings with a maximum aggregate offering
price of $50,000,000. Each time we sell any of our common stock, we will provide a prospectus
supplement that will contain specific information about the offering. This prospectus and the
prospectus supplements provide you with a general description of the company and our common stock;
for further information about our business and our securities, you should refer to the registration
statement, the reports incorporated by reference in this prospectus, and its exhibits. The exhibits
to our registration statement contain the full text of certain contracts and other important
documents we have summarized in this prospectus. Since these summaries may not contain all the
information that you may find important in deciding whether to purchase the securities we may
offer, you should review the full text of these documents. The registration statement can be
obtained from the SEC as indicated under the heading Where You Can Find More Information.
You should rely only on the information contained or incorporated by reference in this
prospectus and the prospectus supplement. We have not authorized anyone to provide you with
different information. If anyone provides you with different or inconsistent information, you
should not rely on it. We will not make an offer to sell these securities in any jurisdiction where
the offer or sale is not permitted. You should assume that the information appearing in this
prospectus, as well as information we previously filed with the SEC and incorporated by reference
in this prospectus, is accurate only as of the date on the front cover of this prospectus. Our
business, financial condition, results of operations and prospects may have changed since that
date.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus contains 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 to management, and use words such as
expect, anticipate, intend, plan, believe, estimate, may, could, possible,
forecast, or similar words and expressions. Forward-looking statements include information
concerning possible or assumed future results of operations, future product development and related
clinical trials and statements regarding future research and development. 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 the forward-looking statements. These risks and
uncertainties are discussed in the Risk Factors section and elsewhere in this prospectus.
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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, including but not limited
to:
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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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pre-launch, marketing, and other expenses related to product candidate ESTRASORB, if
approved by the FDA, |
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general working capital, and |
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possible future acquisitions of complementary businesses, product lines or technologies,
although no such transactions are currently under negotiation. |
We have not determined the amounts we plan to spend on any of the areas listed above or the
timing of these 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. As a result, our management will have broad
discretion to allocate the net proceeds from this offering. Pending application of the net proceeds
as described above, we intend to invest the net proceeds of this offering in short-term,
interest-bearing, investment-grade securities.
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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. |
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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 purchase price of the common stock being offered 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 common stock 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 and agents that participate in the distribution of the common stock 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 common stock
may be treated as underwriting discounts and commissions under the Securities Act. We will identify
in the applicable prospectus supplement any underwriters, dealers or agents and will describe their
compensation. We may have agreements with underwriters, dealers and agents to indemnify them
against specified civil liabilities, including liabilities under the Securities Act. Underwriters,
dealers and agents 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 or broker-dealers regarding the sale of their securities. As of the date of
this prospectus, there are no special selling arrangements between any broker-dealer or other
person and the Company. No period of time has been fixed within which the shares will be offered or
sold.
If required under applicable state securities laws, we will sell the common stock only through
registered or licensed brokers or dealers. In addition, in some states, we may not sell shares of
common stock 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.
Agents
We may designate agents who agree to solicit purchases for the period of their appointment or
to sell
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common stock 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 common stock 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 common stock, the underwriters will acquire the common
stock for their own account. The underwriters may resell the common stock 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 common
stock 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
shares of common stock 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 common stock to a dealer
as a principal, then the dealer may resell those shares 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 common stock 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 common stock 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 the 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 of the common stock 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 common stock originally sold by the dealer are purchased in a covering transaction
to cover short positions. Those activities may cause the price of the common stock to be higher
than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at
any time. These transactions may be effected on the Nasdaq Stock Market or otherwise.
Passive Market Making
Any underwriters who are qualified market markers on the Nasdaq National Market may engage in
passive market making transactions in the common stock on the Nasdaq National 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 of the common stock. Passive market makers must comply with
applicable volume and price limitations and
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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 common
stock, as well as the expense of all commissions and discounts, if any, attributable to the sales
of the common stock by us.
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DESCRIPTION OF OUR CAPITAL STOCK
Our authorized capital stock consists of: (i) 50,000,000 shares of common stock, par value
$.01 per share, of which 30,142,300 shares were outstanding as of August 8, 2003, and (ii)
2,000,000 shares of preferred stock, par value $.01 per share, none of which are outstanding.
Our common stock is traded on the Nasdaq National Market under the symbol NVAX. On August 8,
2003, the closing price of our common stock as reported on the Nasdaq National Market was $5.66 per
share.
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. Accordingly, holders of a
majority of the shares of our common stock entitled to vote in any election of directors may elect
all of the directors standing for election. 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 our Company, the holders of our common stock are
entitled to receive ratably the net assets of our Company available after the payment of all debts
and liabilities and subject to the prior rights of any outstanding preferred stock. 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.
Preferred Stock
The Board of Directors may, without further action by the stockholders of our Company, issue
preferred stock in one or more series and fix the rights and preferences thereof, including the
dividend rights, dividend rates, conversion rights, voting rights, pre-emptive rights, terms of
redemption (including sinking fund provisions), redemption prices and liquidation preferences. Our
Amended and Restated 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.
The issue 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 our
Company. We have no present plans to issue any shares of preferred stock.
Options and Warrants
The Novavax 1995 Stock Option Plan (the Plan) was adopted by the Board of Directors and
approved by the stockholders in September, 1995 and will terminate in 2005. The Plan was amended by
resolution of the Board of Directors adopted in March 1998 and approved by the stockholders in May
1998 to increase the number of shares as to which options may be granted from 4,000,000 to
4,400,000. The Plan was again amended by resolution of the Board of Directors adopted in March 2000
and approved by the stockholders in May 2000 to increase the number of shares as to which options
may be granted from 4,400,000 to 6,000,000. The Plan was again amended by resolution of the Board
of Directors adopted in March 2002 and approved by the stockholders in May 2002 to increase the
number of shares as to which options may be granted from 6,000,000 to 8,000,000. Most recently, the
Plan was amended by resolution of the Board of Directors adopted in March 2003 and approved by the
stockholders in May 2003 to increase the number of shares as to which options may be granted from
8,000,000 to 9,000,000.
Options granted under the Plan may be either incentive stock options within the meaning of
Section 422 of the Internal Revenue Code of 1986, as amended, or options that do not meet the
requirements for incentive stock option treatment, to officers, directors, employees and
consultants or advisors to our Company and any present or future subsidiary to purchase a maximum
of 9,000,000 shares of our common stock. As of August 8, 2003, under both this plan and a prior
stock option plan for directors, there were outstanding options to purchase 4,684,908 shares of our
common stock at an average exercise price of $5.46 per share. There were 1,819,009 shares available
for future grant as of August 8, 2003.
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In addition, we have granted warrants to consultants. At August 8, 2003, there were
outstanding warrants to purchase 70,000 shares of our common stock at an exercise price of $6.00
per share.
Convertible Notes
We have issued four convertible notes to King Pharmaceuticals, Inc. that are currently
convertible into an aggregate of 5,075,241 shares of our common stock. The conversion price of each
of the notes represents an 18% premium to the 20 day trading average preceding the agreed-upon
lock-in dates prior to the issuance of each of the notes. The notes carry a 4% coupon payable
semi-annually in cash and stock. The notes allow the Company the option, under certain
circumstances, to pay up to 50% of the interest due in our common stock.
We can require King to convert the notes into our common stock at any time from January 1,
2002 through December 31, 2004 if the closing price of our common stock exceeds 180% of the
conversion price then in effect for at least 30 trading days in any period of 45 consecutive
trading days. After December 31, 2004, we can redeem the notes at 102%, 101% and 100% of face value
during the years ended December 31, 2005, 2006 and 2007, respectively.
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 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 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 rights plan).
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 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 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.
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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.
Transfer Agent
Our registrar and transfer agent for all shares of common stock is Equiserve, 150 Royall
Street, Canton, MA 02021.
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 shares of common stock offered hereby have been
passed upon by White White & Van Etten LLP, 55 Cambridge Parkway, Cambridge, Massachusetts 02142.
David A. White, a partner of such firm, owns 50,000 shares of our common stock.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated financial statements
included in our Annual Report on Form 10-K for the year ended December 31, 2002, as set forth in
their report, which is incorporated by reference in this prospectus and elsewhere in the
registration statement. Our financial statements 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 450 Fifth Street, N.W., Washington, D.C. 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 rooms. Our
filings with the SEC are also available to you over the Internet at the SECs web site at
http://www.sec.gov.
Our common stock is traded as National Market Securities on the Nasdaq National 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 common shares 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,
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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 the information we file with it, which means
that we can disclose important information to you by referring you to those documents. 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. We incorporate
by reference the documents listed below and any future filings made with the SEC under Section
13(a), 13(c), 14 or 15(d) of the Exchange Act until the selling stockholders sell all of their
shares of common stock or the offering is otherwise terminated. The documents we are incorporating
by reference are:
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1. |
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Our Annual Report on Form 10-K for the fiscal year ended December 31,
2002, as filed with the SEC on March 28, 2003; |
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2. |
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Quarterly Reports on Form 10-Q for the quarters ended: |
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a. |
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March 31, 2003, as filed with the SEC on May 15, 2003; |
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b. |
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June 30, 2003, as filed with the SEC on August 13,
2003; and |
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c. |
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September 30, 2003, as filed with the SEC on November
12, 2003. |
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3. |
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Current Reports on Form 8-K filed with the SEC on May 14, 2003 and
August 8, 2003; |
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4. |
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Definitive Proxy Statement with respect to the Annual Meeting of
Stockholders held on May 7, 2003, as filed with the SEC on March 31, 2003; |
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5. |
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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; and |
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6. |
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All other reports filed by us under Section 13(a) or 15(d) of the
Exchange Act since the end of our fiscal year ended December 31, 2002. |
You may request a copy of these filings at no cost by writing or telephoning our chief
financial officer at the following address and telephone number: Novavax, Inc., 8320 Guilford Road,
Columbia, MD 21046; (301) 854-3900. Attn: Dennis Genge.
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. Also
note that we provide a cautionary discussion of risks and uncertainties relevant to our business in
the Risk Factors section of this prospectus. These are factors that we think could cause our
actual results to differ materially from expected results. Other factors besides those listed here
could also adversely affect us. This discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
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