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. 333-130568
Prospectus Supplement
(to Prospectus dated December 21, 2005)
4,597,700 SHARES
NOVAVAX, INC.
COMMON STOCK
We are offering 4,597,700 shares of our common stock, par value $.01 per share, to select
institutional investors pursuant to this prospectus supplement. The common stock will be purchased
at the negotiated price of $4.35 per share.
Our common stock is traded on the Nasdaq National Market under the symbol NVAX. On February
24, 2006, the closing price of our common stock as reported on the Nasdaq National Market was $5.12
per share.
Investing in our securities involves a high degree of risk. See RISK FACTORS beginning
on page S-4 of this Prospectus Supplement.
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Per Share |
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Offering |
Offering price to select institutional investors |
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$ |
4.35 |
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$ |
20,000,000 |
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Proceeds to Novavax (before expenses) |
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$ |
4.35 |
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$ |
20,000,000 |
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We estimate the total expenses of this offering will be approximately $100,000.
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.
February 28, 2006
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-3 |
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Summary Consolidated Financial Data |
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S-4 |
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Risk Factors |
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S-5 |
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Special Note Regarding Forward-Looking Statements |
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S-15 |
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Use of Proceeds |
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S-16 |
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Dilution |
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S-17 |
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Plan of Distribution |
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S-18 |
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Legal Matters |
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S-18 |
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PROSPECTUS
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Page |
Prospectus Summary |
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3 |
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Summary Consolidated Financial Data |
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4 |
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Risk Factors |
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5 |
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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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Description of Our Warrants |
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26 |
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Dividend Policy |
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28 |
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Legal Matters |
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28 |
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Experts |
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28 |
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Where You Can Find More Information |
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28 |
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Incorporation of Certain Information by Reference |
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28 |
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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 $100,000,000, of which this offering is a part. 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, including the Risk Factors section below, and those additional
documents to which we refer you before deciding to invest in our common stock. See Where You Can
Find More Information on page 28 of the accompanying prospectus.
Our Business
During 2005, Novavax successfully transitioned from a specialty pharmaceutical company, which
included the sales and marketing of products serving the womens health space, to an innovative,
product development company. We have a unique blend of capabilities consisting of formulation
technologies, vaccine technologies and drug development infrastructure, including commercial and
clinical production facilities. We are leveraging our capabilities to develop differentiated,
value-added pharmaceutical and vaccine products and licensing them at various stages of development
to realize their value.
With this portfolio of capabilities, we are uniquely positioned to address the public health
threat of a pandemic created by the avian influenza virus, and we are focused to leverage our
strengths to develop a vaccine against avian influenza. In addition, we have developed a unique
manufacturing process for creating a virus-like particle (VLP) based avian flu vaccine using Wave
Biotechs disposable bag technology that redefines the concept of surge capacity. Our overall
solution to the pandemic influenza problem is compelling and we believe it will be competitive for
several of the government funds that are being allocated for avian influenza pandemic preparedness.
In addition to developing a pandemic flu vaccine, we are also engaged in the development of a
seasonal influenza vaccine.
In addition to investing research funds in vaccines, we continue to expand our products and
product candidates based on our unique formulation technologies. ESTRASORB®, our first
internally-developed product using our proprietary micellar nanoparticle (MNP) technology, is the
first topical emulsion for estrogen therapy approved by the U.S. Food and Drug Administration for
the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
ESTRASORB was licensed in October 2005 to Esprit Pharma, Inc. for marketing in North America. This
licensing arrangement will provide a minimum cash consideration of $12.5 million within the first
year as well as sales-based milestone payments and a double-digit royalty on all sales. We
retained rights to manufacture the product for Esprit at set prices and retained marketing rights
for all territories outside of North America. Following the success of ESTRASORBs development, we
have developed a pipeline of more than ten product candidates using the MNP technology. We are in
discussions with several pharmaceutical companies to co-develop and co-market/license these
products.
Our strength in formulations is synergistic to our vaccine development efforts in two regards.
First, as the MNP based product candidates become licensed and marketed, they have the potential
to partly fund the vaccine research and development by generating cash in the short term. Second,
we benefit from the technical know-how in the lipid based formulation area to develop new adjuvants
for our vaccine product candidates.
The primary elements of our strategy are:
Leveraging our technological leadership in influenza vaccines. Our recombinant VLP technology
is well suited to create a vaccine against pandemic influenza. This technology addresses several
of the technical and logistical issues associated with a potential pandemic. It allows rapid
creation of new vaccines that have high fidelity to emerging strains of influenza and the
manufacturing process can be rapidly commissioned and scaled up. We are leveraging our leadership
position in this important public health issue to attract top-notch recruits, government funds,
international support and high-quality investors.
Maximizing the commercial impact of ESTRASORB. After licensing ESTRASORB to Esprit Pharma,
Inc. for North American rights, we are aggressively looking to license the rights to market this
product in other territories. In addition, we continue our efforts to improve the packaging of
ESTRASORB to improve our margins on the product.
Continuing to expand on our formulation technologies and our drug development capabilities and
infrastructure to generate cash in the short term. Our proven MNP technology has resulted in
several product candidates that can be licensed to pharmaceutical companies. We have been able to
demonstrate benefits of our formulation for several compounds and are actively seeking to license
these product candidates. In addition, we plan to improve utilization of our research and
development capabilities and at our current Good Manufacturing Practices (cGMP) manufacturing
facilities in Philadelphia, PA, Pacific Grove, CA, and Rockville, MD.
Leveraging our formulation science to develop adjuvants for better vaccines. Adjuvants
improve immunogenicity of vaccines and they are becoming central for competitive advantage of new
vaccines. Our inherent strengths in formulations are well suited to develop new adjuvants, such as
Novasomes®, that can lead to best in class vaccines. These adjuvants can also be
products in themselves and can be licensed to other companies to be used with their antigens.
Developing new technologies, evaluating strategic alliances and acquisitions and fortifying
our intellectual property. We continue to improve upon our current portfolio of technologies in
formulations and vaccines. We believe these improvements will result in new intellectual property,
making us more competitive.
Leveraging collaborations and partnerships to advance products and technologies. We are
engaged in seeking collaborations and partnerships to develop and commercialize our products.
These include partnerships with governmental and academic organizations as well as other industry
partners. Our collaboration with Wave Biotech for the production of our flu vaccine is an example
of such a partnership.
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-2
THE OFFERING
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Common stock offered in this offering
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4,597,700 shares |
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Common stock to be outstanding after
this offering
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54,704,346 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-16. |
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Nasdaq National Market symbol
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NVAX |
The information above is based on 50,106,646 shares of common stock outstanding as of February
28, 2006. It does not include:
6,023,086 shares of common stock issuable upon the exercise of stock options outstanding as
of February 28, 2006 at a weighted average exercise price of $3.77 per share;
1,291,443 shares of common stock reserved for future awards under our 2005 Stock Incentive
Plan as of February 28, 2006; and
5,313,006 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 97,178 shares
issuable based on the gross proceeds of the offering as a result of anti-dilution provisions in the
notes.
S-3
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 nine months ended September 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 nine months ended
September 30, 2005 are not necessarily indicative of the results to be expected for the entire year
ending December 31, 2005 or any future period.
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(amounts in thousands, except number of shares and per share information) |
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For the Nine Months Ended |
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For the Years Ended |
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September 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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Statements of Operations Data: |
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Revenues |
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$ |
5,144 |
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6,214 |
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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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$ |
(15,879 |
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(14,556 |
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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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$ |
(17,329 |
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(15,631 |
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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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$ |
(0.42 |
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(0.43 |
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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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40,873,473 |
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36,040,465 |
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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 September 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 Sheets Data: |
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Total current assets |
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$ |
10,704 |
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32,460 |
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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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$ |
5,996 |
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24,615 |
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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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$ |
60,546 |
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87,600 |
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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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35,000 |
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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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$ |
19,902 |
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43,542 |
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33,281 |
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35,944 |
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8,073 |
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S-4
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 company 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 in implementing our new business
strategy.
We intend to focus our research and development activities on areas in which we have
particular strengths and on technologies that appear promising. These technologies often are on
the cutting edge of modern science. As a result, the outcome of any research or development
program is highly uncertain. Only a very small fraction of these programs ultimately result in
commercial products or even product candidates and a number of events could delay our development
efforts and negatively impact our ability to obtain regulatory approval for, and to market and
sell, a product candidate. Product candidates that initially appear promising often fail to yield
successful products. In many cases, preclinical or clinical studies will show that a product
candidate is not efficacious, or that it raises safety concerns or has other side effects that
outweigh the intended benefit. Success in preclinical or early clinical trials may not translate
into success in large-scale clinical trials. Further, success in clinical trials will likely lead
to increased investment, adversely affecting short-term profitability, to bring such products to
market. Even after a product is approved and launched, general usage or post-marketing studies may
identify safety or other previously unknown problems with the product, which may result in
regulatory approvals being suspended, limited to narrow indications or revoked, or which may
otherwise prevent successful commercialization.
We must identify products and product candidates for development with our technologies and
establish successful government and third-party relationships.
Our long-term ability to generate product-related revenue depends in part on our
ability to identify products and product candidates that may utilize our drug delivery and
biological technologies. If internal efforts do not generate sufficient product candidates, we
will need to identify third parties that wish to license our technologies for development of their
products or product candidates. We may be unable to license our technologies to third parties for
a number of reasons, including:
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an inability to negotiate license terms that would allow us to make an appropriate
return from resulting products; |
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an inability to identify suitable products or product candidates within, or
complementary to, our areas of expertise; or |
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an unwillingness on the part of competitors to utilize the technologies of a competing
company or disclose the existence or status of new products or products candidates under
development. |
Our near and long-term viability will also depend in part on our ability to successfully
establish new strategic collaborations with pharmaceutical and biotechnology companies and
government agencies. Establishing
S-5
strategic collaborations and obtaining government funding are difficult and time-consuming.
Potential collaborators may reject collaborations based upon their assessment of our financial,
regulatory or intellectual property position; government agencies may reject contract or grant
applications based on their assessment of public need, the public interest and our products
ability to address these areas. If we fail to establish a sufficient number of collaborations or
government relationships on acceptable terms, we may not generate sufficient revenue. Even if we
successfully establish new collaborations or obtain government funding, these relationships may
never result in the successful development or commercialization of any product candidates or the
generation of any sales or royalty revenue. Reliance on such relationships also exposes us to a
number of risks. We may not have the ability to control the activities of our partners and cannot
assure you that they will fulfill their obligations to us, including with respect to the license,
development and commercialization of products and product candidates, in a timely manner or at all.
We cannot assure you that such partners will devote sufficient resources to our products and
product candidates or properly maintain or defend our intellectual property rights; we also can
give no assurances that our partners will not utilize such rights in such a way as to invite or
cause litigation. Any failure on the part of our partners to perform or satisfy their obligations
to us could lead to delays in the development or commercialization of products and product
candidates, and affect our ability to realize product revenues. Disagreements, including disputes
over the ownership of technology developed with such collaborators, could result in litigation,
which would be time-consuming and expensive, and may delay or terminate research and development
efforts, regulatory approvals, and commercialization activities. If we or our partners fail to
maintain our existing agreements or in the event we fail to establish agreements as necessary, we
could be required to undertake research, development, manufacturing and commercialization
activities solely at our own expense. These activities would significantly increase our capital
requirements and, given our current limited sales, marketing and distribution capabilities,
significantly delay the commercialization of products and product candidates
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success in large part depends on our ability to maintain the proprietary nature of our
technology and other trade secrets, including our proprietary drug delivery and biological
technologies. To do so, we must prosecute and maintain existing patents, obtain new patents and
pursue trade secret and other intellectual property protection. We also must operate without
infringing the proprietary rights of third parties or letting third parties infringe our rights. We
currently have 57 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.
S-6
We have limited financial resources and we are not certain that we will be able to obtain
financing to maintain our operations or to fund the development of future products.
Over the next few years we may not generate revenues from product sales, licensing fees,
royalties, milestones, contract research and other sources in an amount sufficient to fund our
operations, and we will therefore use our cash resources and could require additional funds to
maintain our operations, continue our research and development programs, commence future
preclinical and clinical trials, seek regulatory approvals and market our products. We will seek
such additional funds through public or private equity or debt financings, collaborative
arrangements and other sources. We cannot be certain that adequate additional funding will be
available to us on acceptable terms, if at all. If we cannot raise the additional funds required
for our anticipated operations, we may be required to delay significantly, reduce the scope of or
eliminate one or more of our research or development programs, downsize our general and
administrative infrastructure or programs, or seek alternative measures to avoid insolvency,
including arrangements with collaborative partners or others that may require us to relinquish
rights to certain of our technologies, product candidates or products. If we raise additional funds
through future offerings of shares of our common stock or other securities, such offerings would
cause dilution of existing stockholders percentage ownership in the company. These future
offerings also could have a material and adverse effect on the price of our common stock.
We have a history of losses and our future profitability is uncertain.
Our expenses have exceeded our revenues since our formation in 1987, and our accumulated
deficit at September 30, 2005 was $148.0 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 nine months ended
September 30, 2005 and 2004, our revenues were $5.1 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 $17.3 million and $15.6 million for the nine months ended September 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.
Many of our competitors have significantly greater resources and experience, which may
negatively impact our commercial opportunities and those of our current and future licensees.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid
and significant technological change. We have many potential competitors, including major drug and
chemical companies, specialized biotechnology firms, academic institutions, government agencies and
private and public research institutions. Many of our competitors have significantly greater
financial and technical resources, experience and expertise in:
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research and development; |
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preclinical testing; |
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clinical trials; |
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regulatory processes and approvals; |
S-7
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production and manufacturing; and |
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sales and marketing of approved products. |
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, obtaining regulatory approvals to
market products, and manufacturing such products on a broad scale.
Smaller or early-stage companies and research institutions may also prove to be significant
competitors, particularly through collaborative arrangements with large and established
pharmaceutical or other companies. We will also face competition from these parties in recruiting
and retaining qualified scientific and management personnel, establishing clinical trial sites and
patient registration for clinical trials, and in acquiring and in-licensing technologies and
products complementary to our programs or potentially advantageous to our business. If any of our
competitors succeeds in obtaining approval from the 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 the terms of or decisions regarding the License and Supply Agreements or
other adverse developments in our relationship with Esprit may harm our business and might
accelerate our need for additional capital. We also can give no assurances that Esprit will be
more successful than Novavax in gaining market acceptance of ESTRASORB. Prescription trends for
ESTRASORB have not met our expectations to date and Esprit will face similar obstacles to gaining
market share of the estrogen therapy market, including competition from large and established
companies with similar estrogen therapy products.
Numerous companies worldwide currently produce and sell estrogen products for clinical
indications identical to those for ESTRASORB. Currently, the oral and patch product segments
account for approximately 75% and 15% of the market, respectively, according to 2004 Verispan data.
Wyeth commits significant resources to the sale and marketing of its product,
Premarin®, in order to maintain its market leadership position. Several other companies
compete in the estrogen category including Berlex Laboratories, Inc., Novartis Pharma AG and Solvay
Pharmaceuticals. In particular, Solvay has introduced an alcohol-based gel product, Estrogel,
which is directly competitive with ESTRASORB. These and other products sold by our competitors
have all achieved a degree of market penetration superior to ESTRASORB.
S-8
In addition, under the Supply Agreement, we are obligated to supply Esprit with ESTRASORB
through the manufacture of the product at our manufacturing facility in Philadelphia, Pennsylvania.
We have only limited experience with the large capacity manufacturing required for the commercial
sale of a product. Although we have validated our manufacturing methods for the product with the
FDA, we will remain subject to that agencys rules and regulations regarding good manufacturing
practices, which are enforced by the FDA through its facilities inspection program. Compliance
with such rules and regulations requires us to spend substantial funds and hire and retain
qualified personnel. We face the possibility that we may not be able to meet Esprits supply
requirements under the agreement in a timely fashion at acceptable quality, quantity and prices or
in compliance with applicable regulations. If our facility fails to comply with applicable
regulations, we will be forced to utilize a third party contractor to manufacture the product. We
may not be able to enter into alternative manufacturing arrangements at commercially acceptable
rates, if at all. Moreover, the manufacturers we use may not provide sufficient quantities of
product to meet our specifications or our delivery, cost and other requirements.
We must utilize our manufacturing facility for products other than ESTRASORB in order to avoid
operating the facility at a loss.
Currently we are manufacturing ESTRASORB at our facility in Philadelphia and will manufacture
the product at a loss until production volumes increase or we enter into additional contract
manufacturing arrangements with third parties to more fully utilize the facilitys capacity. The
facility is able to accommodate a much greater production schedule than its current 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 products sold 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 IND that explains to the FDA the results of pre-clinical testing conducted in laboratory
animals and what we propose to do for human testing. At this stage, the FDA decides whether it is
reasonably safe to move forward with testing the drug on humans. We must then conduct Phase I
studies and larger-scale Phase II and III human clinical trials that demonstrate the safety and
efficacy of our products to the satisfaction of the FDA. Once these trials are complete, an NDA
can be filed with the FDA requesting approval of the drug for marketing.
Vaccine clinical development follows the same general pathway as for drugs and other
biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an IND
describing the vaccine, its method of manufacture and quality control tests for release.
Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases. Initial
human studies, referred to as Phase I, are safety and immunogenicity studies performed in a small
number of closely monitored subjects. Phase II studies are dose-ranging studies and may enroll
hundreds of subjects. Finally, Phase III trials typically enroll thousands of individuals and
provide the critical documentation of effectiveness and important additional safety data required
for licensing.
S-9
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 IV studies after a BLA has been approved and the
vaccine is licensed and on the market.
These processes are expensive and can take many years to complete, and we may not be able to
demonstrate the safety and efficacy of our products to the satisfaction of such regulatory
authorities. Regulatory authorities may also require additional testing and we may be required to
demonstrate that our proposed products represent an improved form of treatment over existing
therapies, which we may be unable to do so without conducting further clinical studies. Moreover,
if the FDA grants regulatory approval of a product, the approval may be limited to specific
indications or limited with respect to its distribution. Expanded or additional indications for
approved drugs may not be approved, which could limit our revenues. Foreign regulatory authorities
may apply similar limitations or may refuse to grant any approval. Consequently, even if we
believe that preclinical and clinical data are sufficient to support regulatory approval for our
product candidates, the FDA and foreign regulatory authorities may not ultimately grant approval
for commercial sale in any jurisdiction. If our drug candidates are not approved, our ability to
generate revenues may be limited and our business will be adversely affected.
We may fail to obtain regulatory approval for our products on a timely basis or comply with
our continuing regulatory obligations after approval is obtained.
Delays in obtaining regulatory approval can be extremely costly in terms of lost sales
opportunities and increased clinical trial costs. The speed with which we complete our clinical
trials and our applications for marketing approval will depend on several factors, including the
following:
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the rate of patient enrollment and retention, which is a function of many factors,
including the size of the patient population, the proximity of patients to clinical sites,
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Institutional Review Board approval of the protocol and the informed consent form; |
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prior regulatory agency review and approval; |
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our ability to manufacture or obtain sufficient quantities of materials for use in clinical trials; |
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negative test results or side effects experienced by trial participants; |
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analysis of data obtained from preclinical and clinical activities, which are
susceptible to varying interpretations and which interpretations could delay, limit or
prevent regulatory approval; |
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changes in the policies of regulatory authorities for drug or vaccine approval during
the period of product development; and |
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the availability of skilled and experienced staff to conduct and monitor clinical
studies and to prepare the appropriate regulatory applications. |
We have limited experience in conducting and managing the preclinical and clinical trials
necessary to obtain regulatory marketing approvals. We may not be able to obtain the approvals
necessary to conduct clinical studies. We also face the risk that the results of our clinical
trials may be inconsistent with the results obtained in preclinical studies or that the results
obtained in later phases of clinical trials may be inconsistent with those obtained in earlier
phases. A number of companies in the specialty biopharmaceutical and product development industry
have suffered significant setbacks in advanced clinical trials, even after experiencing promising
results in early animal and human testing. If regulatory approval of a drug is granted, such
approval is likely to limit the indicated uses for which it may be marketed.
S-10
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 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.
Our substantial indebtedness could adversely affect our cash flow and prevent us from
fulfilling our obligations.
As of February 28, 2006, we had approximately $30.5 million of outstanding indebtedness. Our
substantial amount of outstanding indebtedness could have significant consequences. For example,
it:
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could increase our vulnerability to general adverse economic and industry conditions; |
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requires us to dedicate a substantial portion of our cash flow from operations to
service payments on our indebtedness, reducing the availability of our cash flow to fund
future capital expenditures, working capital, execution of our growth strategy, research
and development costs and other general corporate requirements; |
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could limit our flexibility in planning for, or reacting to, changes in our business and
the industry, which
may place us at a competitive disadvantage compared with competitors that have less
indebtedness; and
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S-11
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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 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, 2005, accrued interest receivable related to
the borrowing was $284,000. 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.
S-12
The conversion of our outstanding convertible debt, and the issuance of shares of our common
stock upon conversion or exercise of preferred stock and/or warrants or in future offerings would
cause dilution of existing security holders interests in the company and may cause the price of
our common stock to go down.
As of December 31, 2005, we had outstanding convertible notes in the aggregate principal
amount of $29,000,000 that as of such date were convertible into an aggregate of 5,215,827 shares
of our common stock. The issuance of shares of our common stock upon conversion of such notes, as
well as in connection with future capital raising activities, would cause immediate and potentially
substantial equity dilution for existing stockholders and the price of our common stock could be
subject to significant downward pressure.
We have never paid dividends on our capital stock, and we do not anticipate paying any such
dividends in the foreseeable future.
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future. In addition, the terms of our existing and any
future debt may preclude us from paying dividends. As a result, capital appreciation, if any, of
our common stock would be the only source of gain for stockholders until dividends are permitted
and paid.
Provisions of our Certificate of Incorporation and By-laws, Delaware law, and our Shareholder
Rights Plan could delay or prevent the acquisition of the company, even if such acquisition would
be beneficial to stockholders, and could impede changes in our Board.
Provisions of Delaware corporate law and our organizational documents could hamper a third
partys attempt to acquire, or discourage a third party from attempting to acquire control of, the
company. Moreover, our shareholder rights plan empowers our Board to delay or negotiate, and
thereby possibly thwart, any tender offer or takeover attempt the Board opposes. Stockholders who
wish to participate in these transactions may not have the opportunity to do so. These provisions
also could limit the price investors are willing to pay in the future for our securities and make
it more difficult to change the composition of our Board in any one year. These provisions include
the right of the Board to issue preferred stock with rights senior to those of the common stock
without any further vote or action by stockholders, the existence of a staggered Board with three
classes of directors serving staggered three-year terms, advance notice requirements for
stockholders to nominate directors and make proposals, and a Delaware statutory provision
prohibiting certain transactions between Novavax and interested stockholders.
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.
S-13
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 4,597,700 shares of our common stock at a public
offering price of $4.35 per share, an additional 97,178 shares of common stock will be issuable
upon the conversion of $29,000,000 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-14
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, should,
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-15
USE OF PROCEEDS
After deducting estimated expenses of this offering, we will receive net proceeds from this
offering of approximately $19,900,000.
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-16
DILUTION
Our net tangible book value at September 30, 2005 was $19.9 million, or $0.45 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 September 30, 2005.
Assuming that we issue an aggregate of 4,597,700 shares of our common stock at a public offering
price of $4.35 per share, with estimated net proceeds to us (after assumed fees and expenses) of
$19,900,000, our pro forma net tangible book value at September 30, 2005 would have been $39.8
million, or $0.82 per share. This represents an immediate increase in the tangible book value of
$0.37 per share to our existing stockholders and an immediate dilution of $3.53 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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4.35 |
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Net tangible book value per share as of September 30, 2005 |
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0.45 |
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Increase per share attributable to new investors |
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0.37 |
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0.82 |
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Dilution per share to new investors |
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3.53 |
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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 September 30, 2005. At February 28, 2006,
there were options outstanding to purchase a total of 6,023,086 shares of our common stock at a
weighted average exercise price of $3.77 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
4,597,700 shares of our common stock at a public offering price of $4.35 per share, an additional
97,178 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-17
PLAN OF DISTRIBUTION
We are offering the shares of our common stock without a placement agent and pursuant to a
Securities Purchase Agreement which 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 4,597,700 shares of common stock will take place
on or about February 28, 2006. 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, we will receive funds in the amount of the aggregate purchase
price directly from investors. We will reimburse certain expenses of the investors in an amount
not to exceed $50,000.
The estimated offering expenses payable by us, including the reimbursement of expenses
described above, are approximately $100,000, which includes legal, accounting and printing costs
and various other fees associated with registering and listing the shares of common stock. We
expect the net proceeds from this offering to be approximately $19,900,000.
We have agreed to indemnify the purchasers against certain liabilities, including liabilities
under the Securities Act of 1933, as amended.
The 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. Gunderson Dettmer Stough Villeneuve
Franklin & Hachigian, LLP in Waltham, Massachusetts and Fenwick & West LLP of Mountain View,
California are acting as counsel for the investors.
S-18
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.
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PROSPECTUS
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Subject to Completion, Dated
December 21, 2005 |
$100,000,000
Common Stock
Preferred Stock
Warrants
We may issue and sell from time to time our common stock, preferred stock and/or warrants
on terms to be determined at the time of sale. We may offer these securities separately or
together in one or more offerings with a maximum aggregate offering price of $100,000,000. This
means:
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we will provide a prospectus supplement each time we issue securities, specifying
the securities being sold; 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. |
You should read this prospectus and any prospectus supplement, including any information
incorporated herein and therein, carefully before you invest. This prospectus may not be used to
offer or sell securities unless accompanied by a prospectus supplement for the securities being
sold.
The securities being sold may be sold on a delayed or continuous basis directly by us, through
dealers, agents or underwriters designated from time to time, or through any combination of these
methods. See Plan of Distribution in this prospectus and any prospectus supplement. If any
dealers, agents or underwriters are involved in the sale of the securities in respect of which this
prospectus is being delivered, we will disclose their names and the nature of our arrangements with
them in any prospectus supplement. The net proceeds we expect to receive from any such sale will
also be included in the applicable prospectus supplement.
Our common stock is traded on the Nasdaq National Market under the symbol NVAX. On December
15, 2005, the closing price of our common stock as reported on the Nasdaq National Market was $4.39
per share.
Investing in our securities involves a high degree of risk. See RISK FACTORS beginning on page 5.
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 _____________, 200__.
TABLE OF CONTENTS
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Page |
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Prospectus Summary |
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3 |
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Summary Consolidated Financial Data |
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4 |
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Risk Factors |
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5 |
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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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Description of Our Warrants |
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26 |
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Dividend Policy |
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28 |
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Legal Matters |
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28 |
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Experts |
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28 |
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Where You Can Find More Information |
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28 |
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Incorporation of Certain Information by Reference |
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28 |
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You should rely only on the information contained in this prospectus and in any prospectus
supplement (including in any documents incorporated by reference herein or therein). We have not
authorized anyone to provide you with any different information. We are offering to sell our
securities, and seeking offers to buy, only in jurisdictions where offers and sales are permitted.
The information contained in this prospectus and any prospectus supplement is accurate only as of
the date of this prospectus or such prospectus supplement, and the information contained in any
document incorporated herein or therein by reference is accurate only as of the date of such
document incorporated by reference, regardless of the time of delivery or any sale of our
securities.
In this prospectus, we, us, our and the company refer to Novavax, Inc., together with
its subsidiaries, unless the context otherwise requires.
-2-
PROSPECTUS 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 securities, including the Risk
Factors section below, and those additional documents to which we refer you. See Where You Can
Find More Information on page 28.
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 biological 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.
-3-
SUMMARY CONSOLIDATED FINANCIAL DATA
The historical consolidated financial data presented below as of and for each of the periods
ended December 31, 2004, 2003, 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.
Information as of and for the nine months ended September 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 as of and for the nine
months ended September 30, 2005 are not necessarily indicative of the results to be expected for
the entire year ending December 31, 2005 or any future period.
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(amounts in thousands, except share information) |
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For the nine months ended |
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For the years ended |
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September 30, |
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December 31, |
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2005 |
|
|
2004 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
2001 |
|
|
2000 |
|
|
|
(unaudited) |
|
|
(unaudited) |
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Statements of Operations Data: |
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Revenues |
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$ |
5,144 |
|
|
$ |
6,214 |
|
|
$ |
8,260 |
|
|
$ |
11,785 |
|
|
$ |
15,005 |
|
|
$ |
24,066 |
|
|
$ |
2,475 |
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Loss from operations |
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|
(15,879 |
) |
|
|
(14,556 |
) |
|
|
(24,464 |
) |
|
|
(16,054 |
) |
|
|
(21,558 |
) |
|
|
(9,255 |
) |
|
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(12,742 |
) |
Net loss |
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(17,329 |
) |
|
|
(15,631 |
) |
|
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(25,920 |
) |
|
|
(17,273 |
) |
|
|
(22,697 |
) |
|
|
(9,745 |
) |
|
|
(12,191 |
) |
Per share information: |
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Net loss per share |
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$ |
(0.42 |
) |
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$ |
(0.43 |
) |
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$ |
(0.70 |
) |
|
$ |
(0.58 |
) |
|
$ |
(0.93 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.64 |
) |
Weighted average number of
shares outstanding |
|
|
40,873,473 |
|
|
|
36,040,465 |
|
|
|
36,926,034 |
|
|
|
29,852,797 |
|
|
|
24,433,868 |
|
|
|
22,670,274 |
|
|
|
19,015,719 |
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
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|
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|
As of September 30, |
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As of December 31, |
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|
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2005 |
|
|
2004 |
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|
2004 |
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|
2003 |
|
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2002 |
|
|
2001 |
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2000 |
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|
(unaudited) |
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|
(unaudited) |
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Balance Sheet Data: |
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Total current assets |
|
$ |
10,704 |
|
|
$ |
32,460 |
|
|
$ |
23,937 |
|
|
$ |
32,062 |
|
|
$ |
6,242 |
|
|
$ |
25,027 |
|
|
$ |
17,036 |
|
Working capital |
|
|
5,996 |
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|
|
24,615 |
|
|
|
15,361 |
|
|
|
27,226 |
|
|
|
378 |
|
|
|
18,030 |
|
|
|
12,331 |
|
Total assets |
|
|
60,546 |
|
|
|
87,600 |
|
|
|
77,993 |
|
|
|
84,159 |
|
|
|
57,505 |
|
|
|
67,115 |
|
|
|
56,529 |
|
Convertible debt |
|
|
35,000 |
|
|
|
35,000 |
|
|
|
35,000 |
|
|
|
40,000 |
|
|
|
40,000 |
|
|
|
30,000 |
|
|
|
20,000 |
|
Stockholders equity |
|
|
19,902 |
|
|
|
43,542 |
|
|
|
33,281 |
|
|
|
35,944 |
|
|
|
8,073 |
|
|
|
27,493 |
|
|
|
31,824 |
|
-4-
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 supplement and incorporated by reference herein and therein before
purchasing our securities. The risks and uncertainties described below are not the only ones facing
us. Additional risks and uncertainties that we are unaware of, or that we currently deem
immaterial, also may become important factors that affect us. If any of the following risks occur,
our business, financial condition or results of operations could be materially and adversely
affected. In that case, the value of our securities could decline, and you may lose some or all of
your investment.
RISKS RELATED TO OUR BUSINESS
We have repositioned ourselves from a specialty biopharmaceutical company to a 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. Establishing
-5-
strategic collaborations and obtaining government funding are difficult and time-consuming.
Potential collaborators may reject collaborations based upon their assessment of our financial,
regulatory or intellectual property position; government agencies may reject contract or grant
applications based on their assessment of public need, the public interest and our products
ability to address these areas. If we fail to establish a sufficient number of collaborations or
government relationships on acceptable terms, we may not generate sufficient revenue.
Even if we successfully establish new collaborations or obtain government funding, these
relationships may never result in the successful development or commercialization of any product
candidates or the generation of any sales or royalty revenue. Reliance on such relationships also
exposes us to a number of risks. We may not have the ability to control the activities of our
partners and cannot assure you that they will fulfill their obligations to us, including with
respect to the license, development and commercialization of products and products candidates, in a
timely manner or at all. We cannot assure you that such partners will devote sufficient resources
to our products and product candidates or properly maintain or defend our intellectual property
rights; we also can given no assurances that they will not utilize such rights in such a way as to
invite or cause litigation. Any failure on the part of our partners to perform or satisfy their
obligations to us could lead to delays in the development or commercialization of products and
product candidates, and affect our ability to realize product revenues. Disagreements, including
disputes over the ownership of technology developed with such collaborators, could result in
litigation, which would be time-consuming and expensive, and may delay or terminate research and
development efforts, regulatory approvals, and commercialization activities. If we or our partners
fail to maintain our existing agreements or in the event we fail to establish agreements as
necessary, we could be required to undertake research, development, manufacturing and
commercialization activities solely at our own expense. This would significantly increase our
capital requirements and, given our current limited sales, marketing and distribution capabilities,
significantly delay the commercialization of products and product candidates.
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success in large part depends on our ability to maintain the proprietary nature of our
technology and other trade secrets, including our proprietary drug delivery and biological
technologies. To do so, we must prosecute and maintain existing patents, obtain new patents and
pursue trade secret and other intellectual property protection. We also must operate without
infringing the proprietary rights of third parties or letting third parties infringe our rights. We
currently have 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.
-6-
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 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 nine months ended
September 30, 2005 and 2004, our revenues were $5.1 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 $17.3 million and $15.6 million for the nine months ended September 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.
Many of our competitors have significantly greater resources and experience, which may
negatively impact our commercial opportunities and those of our current and future licensees.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid
and significant technological change. We have many potential competitors, including major drug and
chemical companies, specialized biotechnology firms, academic institutions, government agencies and
private and public research institutions. Many of our competitors have significantly greater
financial and technical resources, experience and expertise in:
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research and development; |
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preclinical testing; |
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clinical trials; |
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regulatory processes and approvals; |
-7-
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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 succeeds 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 the 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 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.
-8-
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 in order to avoid
operating the facility at a loss.
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 the results of
pre-clinical testing conducted in laboratory animals and what we propose to do for human testing.
At this stage, the FDA decides whether it is reasonably safe to move forward with testing the drug
on humans. We must then conduct Phase 1 studies and larger-scale Phase 2 and 3 human clinical
trials that demonstrate the safety and efficacy of our products to the satisfaction 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.
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If successful, the completion of all three phases of clinical development can be followed by
the submission of a Biologics License Application (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, the eligibility criteria for the study and the nature of the
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institutional review board approval of the protocol and the informed consent form; |
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prior regulatory agency review and approval; |
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our ability to manufacture or obtain sufficient quantities of materials for use in clinical trials; |
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negative test results or side effects experienced by trial participants; |
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analysis of data obtained from preclinical and clinical activities, which are
susceptible to varying interpretations and which interpretations could delay, limit
or prevent regulatory approval; |
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changes in the policies of regulatory authorities for drug or vaccine approval
during the period of product development; and |
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the availability of skilled and experienced staff to conduct and monitor
clinical studies and to prepare the appropriate regulatory applications. |
We have limited experience in conducting and managing the preclinical and clinical trials
necessary to obtain regulatory marketing approvals. We may not be able to obtain the approvals
necessary to conduct clinical studies. We also face the risk that the results of our clinical
trials may be inconsistent with the results obtained in preclinical studies or that the results
obtained in later phases of clinical trials may be inconsistent with those obtained in earlier
phases. A number of companies in the specialty biopharmaceutical and product development industry
have suffered significant setbacks in advanced clinical trials, even after experiencing promising
results in early animal and human testing. If regulatory approval of a drug is granted, such
approval is likely to limit the indicated uses for which it may be marketed.
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Furthermore, even if a product gains regulatory approval, the product and the manufacturer of
the product will be subject to continuing regulatory review, including adverse event reporting
requirements and the FDAs general prohibition against promoting products for unapproved uses.
Failure to comply with any post-approval requirements can, among other things, result in warning
letters, product seizures, recalls, fines, injunctions, suspensions or revocations of marketing
licenses, operating restrictions and criminal prosecutions. Any of these enforcement actions, any
unanticipated changes in existing regulatory requirements or the adoption of new requirements, or
any safety issues that arise with any approved products, could adversely affect our ability to
market products and generate revenues and thus adversely affect our ability to continue our
business.
We also may be restricted or prohibited from marketing or manufacturing a product, even after
obtaining product approval, if previously unknown problems with the product or its manufacture are
subsequently discovered and we cannot assure you that newly discovered or developed safety issues
will not arise following any regulatory approval. With the use of any drug by a wide patient
population, serious adverse events may occur from time to time that initially do not appear to
relate to the drug itself, and only if the specific event occurs with some regularity over a period
of time does the drug become suspect as having a causal relationship to the adverse event. Any
safety issues could cause us to suspend or cease marketing of our approved products, possibly
subject us to substantial liabilities, and adversely affect our ability to generate revenues and
our financial condition.
Our substantial indebtedness could adversely affect our cash flow and prevent us from
fulfilling our obligations.
As of November 30, 2005, we had $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
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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
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could limit our flexibility in planning for, or reacting to, changes in our
business and the industry, which may place us at a competitive disadvantage
compared with competitors that have less indebtedness; and |
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could limit our ability to obtain additional funds, even when necessary to
maintain adequate liquidity. |
We may incur additional indebtedness for various reasons, which would increase the risks
associated with our substantial leverage.
Health care insurers and other payors may not pay for our products or may impose limits on
reimbursement.
Our ability and the ability of our licensees to successfully commercialize ESTRASORB and
future products will depend, in part, on the extent to which reimbursement for such products will
be available from third-party payors such as Medicare, Medicaid, health maintenance organizations,
health insurers and other public and private payors. If we succeed in bringing products to the
market, we cannot be assured that third-party payors will pay for such products or establish and
maintain price levels sufficient for realization of an appropriate return on our investment in
product development. For example, ESTRASORB currently is being sold as an outpatient prescription
drug. Medicare does not cover the costs of most outpatient prescription drugs. We expect that over
time ESTRASORB will be treated the same as other estrogen therapy products with respect to
government and third-party payor reimbursement, however, additional time is required to increase
the number of payors who currently accept our product for reimbursement. There can be no assurance
that ESTRASORB will receive similar
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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 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 November 30, 2005, accrued interest receivable related to
the borrowing was $277,000. 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 OUR SECURITIES
The price of our common stock has been and may continue to be volatile.
Historically, the market price of our common stock has fluctuated over a wide range. In
fiscal year 2004, our common stock traded in a range from $2.88 to $6.99. Between January 1, 2005
and December 15, 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.
The conversion of our outstanding convertible debt, and the issuance of shares of our common
stock in this offering, upon conversion or exercise of preferred stock and/or warrants, and in
future offerings would cause dilution of existing security holders interests in the company and
may cause the price of our common stock to go down.
As
of December 15, 2005, we had outstanding convertible notes in the aggregate principal amount of
$29,000,000 that as of such date were convertible into an aggregate of 5,213,635 shares of our common
stock. The issuance of shares of our common stock upon conversion of such notes, and the issuance
of shares of common stock in this offering and upon the conversion or exercise of preferred stock
and warrants offered hereby, as well as in connection with future capital raising activities, would
cause immediate and potentially substantial equity dilution for existing stockholders and the price
of our common stock could be subject to significant downward pressure.
We have never paid dividends on our capital stock, and we do not anticipate paying any such
dividends in the foreseeable future.
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future. In addition, the terms of our existing and any
future debt may preclude us from paying dividends. As a result, capital appreciation, if any, of
our common stock would be the only source of gain for stockholders until dividends are permitted
and paid.
Provisions of our Certificate of Incorporation and By-laws, Delaware law, and our Shareholder
Rights Plan could delay or prevent the acquisition of the company, even if such acquisition would
be beneficial to stockholders, and could impede changes in our Board.
Provisions of Delaware corporate law and our organizational documents could hamper a third
partys attempt to acquire, or discourage a third party from attempting to acquire control of, the
company. Moreover, our shareholder rights plan empowers our Board to delay or negotiate, and
thereby possibly thwart, any tender offer or takeover attempt the Board opposes. Stockholders who
wish to participate in these transactions may not have the opportunity to do so. These provisions
also could limit the price investors are willing to pay in the future for our securities and make
it more difficult to change the composition of our Board in any one year. These provisions include
the right of the Board to issue preferred stock with rights senior to those of the common stock
without any further vote or action by stockholders, the existence of a staggered Board with three
classes of directors serving staggered three-year terms, advance notice requirements for
stockholders to nominate directors and make proposals, and a Delaware statutory provision
prohibiting certain transactions between Novavax and interested stockholders.
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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 or Commission). By using a shelf registration statement, we
may, from time to time, issue and sell in one or more series or classes our common stock, preferred
stock and/or warrants in one or more offerings up to an aggregate maximum offering price of
$100,000,000 (or its equivalent in foreign or composite currencies). Each time we sell
any of our securities, we will provide a prospectus supplement that will contain more specific
information about the offering and the terms of the securities being sold. We may also add, update
or change in the prospectus supplement any of the information contained in this prospectus or the
documents incorporated by reference.
This prospectus and the prospectus supplements provide you with a general description of the
company and our securities; for further information about our business and our securities, you
should refer to the registration statement, the reports incorporated by reference in this
prospectus, and the 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 and exhibits 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 in this prospectus and in any prospectus
supplement (including in any documents incorporated by reference herein or therein). We have not
authorized anyone to provide you with any different information. We are offering to sell our
securities, and seeking offers to buy, only in jurisdictions where offers and sales are permitted.
The information contained in this prospectus and any prospectus supplement is accurate only as of
the date of this prospectus or such prospectus supplement, and the information contained in any
document incorporated herein or therein by reference is accurate only as of the date of such
document incorporated by reference, regardless of the time of delivery or any sale of our
securities.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus and any accompanying prospectus supplement (including any
documents incorporated by reference herein or therein) contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on
managements beliefs and assumptions and on information currently available, and use words such as
expect, anticipate, intend, plan, believe, estimate, may, could, possible,
forecast, or similar words and expressions. Forward-looking statements include but are not
limited to statements regarding usage of cash, product sales, future product development and
related clinical trials, and future research and development, including FDA approval of our product
candidates. Forward-looking statements are only predictions, and necessarily involve risks and
uncertainties and other factors that may cause the actual results, performance or achievements of
Novavax, or industry results, to be materially different from those anticipated in or implied by
the forward-looking statements. These risks, uncertainties and other factors are discussed in the
Risk Factors section and elsewhere in this prospectus and any accompanying prospectus supplement
(including any documents incorporated by reference herein or therein) and include, among other
things, the following:
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general economic and business conditions; |
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ability to enter into future collaborations with industry partners; |
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competition; |
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unexpected changes in technologies and technological advances; |
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ability to obtain rights to technology; |
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ability to obtain and enforce patents; |
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ability to commercialize and manufacture products; |
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ability to maintain commercial-scale manufacturing capabilities; |
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results of clinical studies; |
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progress of research and development activities; |
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business abilities and judgment of personnel; |
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availability of qualified personnel; |
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changes in, or failure to comply with, governmental regulations; |
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ability to obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity financings or otherwise; and |
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other factors referenced in this prospectus and any accompanying prospectus
supplement (including any documents incorporated by reference herein or therein). |
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USE OF PROCEEDS
Except as otherwise described in an applicable prospectus supplement, we currently intend to
use the net proceeds from this offering for general corporate purposes, which may include:
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clinical development of VLP-based avian and seasonal flu vaccines, including the
development of appropriate adjuvants, and demonstration of large-scale production
capabilities, for such vaccines; |
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our internal research and development programs, such as preclinical and clinical
testing and studies of our product candidates and the development of new
technologies; |
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expansion of and investment in our research and development facilities,
including compliance with cGMP and GLP rules and regulations; and |
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general working capital. |
Each time we issue securities, we will provide a prospectus supplement that will contain
information about how we intend to use the proceeds from each such offering.
At this time, we have not determined the specific uses of any offering proceeds, or the
amounts we plan to spend on any particular use or the timing of such expenditures, which may vary
significantly depending on various factors such as our research and development results, regulatory
approvals, competition, marketing and sales, and the market acceptance of any products introduced
by us or our partners. Pending application of the net proceeds from any particular offering, we
intend to invest such proceeds in short-term, interest-bearing, investment-grade securities.
We cannot guarantee that we will receive any proceeds in connection with any offering
hereunder because we may choose not to issue any of the securities covered by this prospectus.
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PLAN OF DISTRIBUTION
We may sell the securities being offered hereby from time to time in one or more of the
following ways:
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through one or more underwriters, |
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through dealers, who may act as agents or principal (including a block trade in
which a broker or dealer so engaged will attempt to sell the shares as agent but
may position and resell a portion of the block as principal to facilitate the
transaction), |
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directly to one or more purchasers, |
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through agents, |
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in privately negotiated transactions, and |
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in any combination of these methods of sale. |
We will set forth in a prospectus supplement the terms of the offering of securities, including:
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the name or names of any agents, underwriters or dealers, |
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the terms of the securities being offered, including the purchase price and the
proceeds we will receive from the sale, |
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any underwriting discounts and commissions or agency fees and other items
constituting underwriters or agents compensation, |
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any over-allotment options under which underwriters may purchase additional
securities from us, and |
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any discounts or concessions allowed or reallowed or paid to dealers. |
The distribution of the securities may be effected from time to time in one or more
transactions at a fixed price or prices, which may be changed, at market prices prevailing at the
time of sale, at prices related to the prevailing market prices, or at negotiated prices.
Underwriters, dealers, agents and others that participate in the distribution of the
securities may be underwriters as defined in the Securities Act of 1933, as amended (the
Securities Act) and any discounts or commissions they receive from us and any profit on their
resale of the securities may be treated as underwriting discounts and commissions under the
Securities Act. We will identify in the applicable prospectus supplement any underwriters,
dealers, agents and others and will describe their compensation. We may have agreements with
underwriters, dealers, agents and others to indemnify them against specified civil liabilities,
including liabilities under the Securities Act. Underwriters, dealers, agents and others may
engage in transactions with or perform services for us in the ordinary course of their businesses.
We have not entered into any agreements, understandings or arrangements with any underwriters,
broker-dealers or other parties regarding the sale of securities. As of the date of this
prospectus, there were no special selling arrangements between any broker-dealer or other person
and the company. No period of time has been fixed within which the securities will be offered or
sold.
If required under applicable state securities laws, we will sell the securities only through
registered or licensed brokers or dealers. In addition, in some states, we may not sell securities
unless they have been registered or qualified for sale in the applicable state or unless we have
complied with an exemption from any registration or qualification requirements.
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Agents
We may designate agents who agree to solicit purchases for the period of their appointment or
to sell securities on a continuing basis. Unless the prospectus supplement provides otherwise,
agents will act on a best efforts basis for the period of their appointment. Agents may receive
compensation in the form of commissions, discounts or concessions from us. Agents may also receive
compensation from the purchasers of the securities for whom they sell as principals. Each
particular agent will receive compensation in amounts negotiated in connection with the sale, which
might be in excess of customary commissions.
Underwriters
If we use underwriters for a sale of securities, the underwriters will acquire the securities
for their own account. The underwriters may resell the securities in one or more transactions,
including negotiated transactions, at a fixed public offering price or at varying prices determined
at the time of sale. The obligations of the underwriters to purchase the securities will be
subject to the conditions set forth in the applicable underwriting agreement. Unless the
prospectus supplement provides otherwise, underwriters will be obligated to purchase all of the
securities offered by the prospectus supplement. We may change from time to time any initial
public offering price and any discounts or concessions the underwriters allow or reallow or pay to
dealers. We may use underwriters with whom we have a material relationship, and we may offer the
securities to the public through an underwriting syndicate or through a single underwriter. We
will describe in the prospectus supplement naming the underwriter the nature of any such
relationship and underwriting arrangement.
Dealers
We also may sell securities to a dealer as principal. If we sell our securities to a dealer
as a principal, then the dealer may resell those securities to the public at varying prices to be
determined by such dealer at the time of resale. The name of the dealer and the terms of the
transactions will be set forth in the applicable prospectus supplement.
Direct Sales and Institutional Purchases
We may also sell securities directly to one or more purchasers, in which case underwriters or
agents would not be involved in the transaction.
Further, we may authorize agents, underwriters or dealers to solicit offers by certain types
of institutional investors to purchase securities from us at the public offering price set forth in
the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery
on a specified date in the future. We will describe the conditions to these contracts and the
commissions we must pay for solicitation of these contracts in an applicable prospectus supplement.
Stabilization Activities
Any underwriter may engage in overallotment, stabilizing transactions, short covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act of 1934, as
amended (the Exchange Act). Overallotment involves sales in excess of the offering size, which
create a short position. Stabilizing transactions permit bids to purchase the underlying security
so long as the stabilizing bids do not exceed a specified maximum. Short covering transactions
involve purchases in the open market after the distribution is completed to cover short positions.
Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the
securities originally sold by the dealer are purchased in a covering transaction to cover short
positions. Such activities may cause the price of the securities to be higher than they would
otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
These transactions may be effected on the Nasdaq Stock Market or otherwise.
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Passive Market Making
Any underwriters who are qualified market markers on the Nasdaq National Market may engage in
passive market making transactions 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. Passive market makers must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market maker must display
its bid at a price not in excess of the highest independent bid for such security; if all
independent bids are lowered below the passive market makers bid, however, the passive market
makers bid must then be lowered when certain purchase limits are exceeded.
Costs
We will bear all costs, expenses and fees in connection with the registration of the
securities, as well as the expense of all commissions and discounts, if any, attributable to sales
of the securities by us.
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DESCRIPTION OF OUR CAPITAL STOCK
For a more complete description of our common and preferred stock, please refer to our Amended
and Restated Certificate of Incorporation (the Certificate of Incorporation) as filed with the
Secretary of State of the State of Delaware, our Amended and Restated By-laws (the By-laws), each
of which is incorporated herein by reference, and any certificate of designation we may file
relating to any preferred stock.
General
Our authorized capital stock consists of: (i) 100,000,000 shares of common stock, par value
$.01 per share, of which 49,980,946 shares were outstanding as of December 15, 2005, and (ii)
2,000,000 shares of preferred stock, par value $.01 per share, none of which are outstanding.
Common Stock
Holders of common stock are entitled to one vote for each share held on all matters submitted
to a vote of stockholders and do not have cumulative voting rights. Generally, all matters to be
voted on by stockholders must be approved by a majority, or, in the case or the election of
directors, by a plurality, of the votes cast at a meeting at which a quorum is present.
Holders of our common stock are entitled to receive ratably such dividends, if any, as may be
declared by the Board of Directors out of funds legally available therefor, subject to any
preferential dividend rights of any outstanding preferred stock. Upon the liquidation, dissolution
or winding up of the company, the holders of our common stock are entitled to receive ratably the
net assets of the company available after the payment of all debts and liabilities and subject to
the prior rights of any outstanding preferred stock.
Holders of our common stock are not entitled to pre-emptive rights or any rights of
conversion. Shares of our common stock are, and the shares being distributed in this offering will
be, when issued, fully paid and nonassessable. The rights, preferences and privileges of holders
of our common stock are subject, and may be adversely affected by, the rights of holders of shares
of any series of preferred stock which we may designate and issue in the future.
Our common stock is traded on the Nasdaq National Market under the symbol NVAX. On December
15, 2005, the closing price of our common stock as reported on the Nasdaq National Market was $4.39
per share.
Our registrar and transfer agent for all shares of common stock is Computershare Limited, 250
Royall Street, Canton, MA 02021.
Preferred Stock
The Board of Directors may, without further action by the stockholders of the company, issue
preferred stock in one or more series and fix the rights and preferences thereof. Our Certificate
of Incorporation grants the Board of Directors authority to issue preferred stock and to determine
its rights and preferences without the need for further stockholder approval to eliminate delays
associated with a stockholder vote on specific issuances.
Examples of rights and preferences the Board of Directors may fix include dividend rights,
dividend rates, conversion rights, voting rights, pre-emptive rights, terms of redemption
(including sinking fund provisions), redemption prices and liquidation preferences. The issuance
of preferred stock, while providing desirable flexibility in connection with possible financings,
could have the effect of making it more difficult for a third party to acquire, or of discouraging
a third party from acquiring, a majority of the outstanding voting stock of the company. The
rights of holders of our common stock, described above, will be subject to, and may be adversely
affected by, the rights of any preferred stock that we may designate and issue in the future.
We will incorporate by reference as an exhibit to the registration statement that includes
this prospectus the form of any certificate of designation that describes the terms of any series
of preferred stock offered. The description and applicable prospectus supplement may include,
among other things:
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the liquidation preference per share; |
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the purchase price; |
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the dividend rate, period and payment date, and method of calculation (including
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terms and amount of any sinking fund; |
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provisions for redemption or repurchase, if applicable, and any restrictions on
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conversion rights and rates, if applicable, including the conversion price and
how and when it will be calculated and adjusted; |
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voting rights, if any; |
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preemptive rights, if any; |
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restrictions on sale, transfer and assignment, if any; |
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the relative ranking and preferences of the preferred stock; and |
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any other specific terms, rights or limitations of, or restrictions on, such preferred stock. |
Please also refer to the description of our Shareholder Rights Plan, below, for a discussion
of the companys Series D Junior Participating Preferred Stock.
Options and Warrants
The Novavax 2005 Stock Incentive Plan (the Plan) was adopted by the Board of Directors and
approved by the stockholders in May 2005 and will terminate in 2015. The Plan provides for the
grant to employees, officers and directors of, as well as consultants and advisors to, the company,
its parents and subsidiaries of stock options, restricted stock awards, stock appreciation rights
and restricted stock units. The number of shares of common stock initially set aside and reserved
for issuance under the Plan was 2,000,000 shares (which amount is subject to adjustment as
described in the Plan). In addition, 565,724 shares held in reserve under the companys former
plan, the Novavax, Inc. 1995 Stock Option Plan, but which were unused (i.e., not subject to
outstanding stock options) at the time of adoption were transferred to the Plan upon stockholder
approval.
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, and may be granted to officers, directors,
employees and consultants or advisors to the company and any present or future subsidiary. As of
December 15, 2005, under both the Plan and the 1995 Stock Option Plan, there were outstanding
options to purchase 5,622,831 shares of our common stock at an average exercise price of $3.41 per
share. There were 1,819,398 shares available for future grant as of December 15, 2005.
As of December 15, 2005, the company had granted awards under the Plan for 552,434 shares of
restricted stock, and had not granted any awards for stock appreciation rights or restricted stock
units.
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Convertible Notes
As
of December 15, 2005, we had outstanding convertible notes in the aggregate principal amount of
$29,000,000 that as of such date were convertible into an aggregate of 5,213,635 shares of our common
stock. Interest on the notes accrues at the rate of 4.75% per year and is payable in arrears in
cash on each January 15 and July 15 during the term of the notes. The interest rate increases to
15% after the occurrence and during the continuance of an event of default.
The notes mature on July 15, 2009. The maturity date may be extended at the option of the
holder in the event and for so long as an event of default exists, as well as through the date that
is 10 days after the consummation of a change in control (as such term is defined in the notes)
of the company. Upon maturity, the company must repay all outstanding principal, accrued and unpaid
interest and accrued and unpaid late charges (if any) on the notes. Novavax may pay up to one-half
of the amount due at maturity in shares of common stock, so long as the company provides sufficient
advance notice of its intent to pay in shares and so long as certain equity conditions (as set
forth in the notes) are satisfied.
Subject to limitations on beneficial ownership and market rules and regulations, at any time
after the date of issuance, a holder may convert any portion of the outstanding principal, unpaid
and accrued interest and unpaid and accrued late charges into shares of common stock of the
company. The initial conversion price was $6.15 per share, and such conversion price is subject to
adjustment as set forth in the notes, including upon the issuance or sale of shares of common stock
at a price less than the then-applicable conversion price.
Holders of the notes have the right to require that the company redeem the notes if the
weighted average price of our common stock is less than the then-applicable conversion price on
each of 30 trading days out of the 40 consecutive trading days immediately preceding either the
third or fourth anniversary of the issue date of the notes, provided that such redemption right
ceases once the company meets the
ESTRASORBTM revenue target (as defined in the notes). Novavax
may elect to pay up to one-half of the redemption price in shares of common stock, but only so long
as the equity conditions are satisfied or waived.
Upon the occurrence of any event of default under the notes, the company must deliver notice
thereof to the holders. A holder thereafter has the right to require the company to redeem all or
any portion of such holders note upon delivery of written notice of redemption. Holders are also
entitled to require the company to redeem their notes upon a change in control. Alternatively,
Novavax may require all of the notes to be redeemed upon the occurrence of a cash transaction (as
such term is defined in the notes). Novavax also may require holders to convert outstanding notes
if, at any time after the third anniversary of the issue date, the weighted average price of a
share of common stock exceeds $10.76 (subject to the adjustment) for 15 trading days out of any 30
consecutive trading days, and the equity conditions have been satisfied or waived.
If at any time during the term of the notes the company issues or sells, or is deemed to have
issued or sold (for example, in connection with the issuance of options exercisable for shares of
common stock), shares of common stock at a price less than the then-applicable conversion price of
the notes, then the conversion price of the notes then in effect will be reduced on a weighted
average basis. The applicable conversion price will also be proportionately increased or decreased
in the event that the company subdivides or combines one or more classes of its outstanding shares
of common stock or any similar event.
All payments due under a note rank pari passu with all other notes in the series, and are
senior to all other indebtedness of the company and its subsidiaries other than permitted
acquisition indebtedness. Holders of the notes are entitled to dividends paid and distributions
made to holders of the companys common stock to the same extent as if such note holders had
converted their notes into shares of common stock (without regard to any limitations on conversion)
and had held such shares of common stock on the record date for such dividends and/or
distributions. Holders of the notes have no voting rights in their capacities as holders of the
Notes, except as required by law and as expressly provided in the notes. The approval of the
holders representing at least a majority of the aggregate principal amount of the notes then
outstanding is required in order to change or amend the notes.
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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 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.
At any time prior to the close of business on the tenth business day after there has been a
public announcement that a person has become an acquiring person or such earlier date as a majority
of the Board shall become aware of the existence of an acquiring person, we may redeem the rights
in whole, but not in part, at a price of $.001 per right. Immediately upon the effective time of
such Board action, the right to exercise the rights will terminate and the only right of the
holders will be to receive the redemption price.
For as long as the rights are then redeemable, we may, except with respect to the redemption
price, amend the rights in any manner, including extending the time period in which the rights may
be redeemed. At any time when the rights are not then redeemable, we may amend the rights in any
manner that does not materially adversely affect the interests of holders of the rights as such.
Provisions of our Certificate of Incorporation and By-laws and Delaware Law
Certain provisions of our Certificate of Incorporation and By-laws may be deemed to have an
anti-takeover effect and may prevent, delay or defer a tender offer or takeover attempt that a
stockholder may deem in his, her or
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its best interest. The existence of these provisions also could limit the price that investors
might be willing to pay for our securities. They include:
Staggered Board, Removal of Directors and Charter Amendments relating to the Board
Our Certificate of Incorporation and By-laws provide for the division of our Board of
Directors into three classes, with no one class having more than one director more than any other
class, serving staggered three year terms. Our By-laws further provide that directors may be
removed only for cause by the affirmative vote of the holders of 2/3 of the shares of capital stock
of the company issued and outstanding and entitled to vote. Moreover, our Certificate of
Incorporation provides that any amendments to the charter relating to the number, classes,
election, term, removal, vacancies and related provisions with respect to the Board may only be
made by the affirmative vote of the holders of at least 75% of the shares of capital stock issued
and outstanding and entitled to vote. These provisions may have the effect of making it more
difficult for a third party to acquire control of Novavax, or of discouraging a third party from
acquiring control of the company.
Authorized but Unissued Shares
The authorized but unissued shares of our common stock and preferred stock are available for
future issuance without stockholder approval, subject to any limitations imposed by The Nasdaq
Stock Market. These additional shares may be utilized for a variety of corporate purposes. In
particular, although our Board of Directors has no present intention to do so, it could issue
shares of preferred stock that could, depending on the terms of the series, impede the completion
of a merger, tender offer, proxy contest or other takeover attempt. Our Board may determine that
the issuance of such shares of preferred stock is in the best interest of the company and our
stockholders. Such issuance could discourage a potential acquiror from making an unsolicited
acquisition attempt through which such acquiror may be able to change the composition of the board,
including a tender offer or other transaction that some, or a majority, of our stockholders might
believe to be in their best interest or in which stockholders might receive a premium for their
stock over the then-current market price.
Advance Notice Requirements for Stockholder Proposals and Director Nominations
Our By-laws provide that a stockholder seeking to bring business before an annual meeting of
stockholders, or to nominate candidates for election as directors, must provide timely notice of
such stockholders intention in writing. To be timely, a stockholders notice must be received not
less than 60 nor more than 90 days prior to the meeting at which such candidate or proposal is to
be considered. However, if the company does not give prior notice or make public disclosure of the
date of the meeting at least 70 days prior to the meeting date, notice is considered timely if it
is received no later than the close of business on the 10th day following the date on
which such notice was given or public disclosure was made (whichever occurred first). If a
stockholder desires to have a proposal included in the companys proxy statement, notice of such
proposal must be received not less than 120 days prior to the first anniversary of the date of the
companys notice of the previous years annual meeting. These advance notice provisions may
preclude stockholders from bringing matters before a meeting or from making nominations for
directors.
Special Meetings of Shareholders
Our By-laws provide that special meetings of shareholders may be called by the Chief Executive
Officer (or, if there is no Chief Executive Officer, the President) or by the Board of Directors,
with no provision for any right of stockholders to call such meetings. Further, business
transacted at any special meeting of stockholders is limited to matters relating to the purpose or
purposes stated in the notice of meeting.
Section 203 of the General Corporation Law of the State of Delaware
We are subject to the provisions of Section 203 of the General Corporation Law of the State of
Delaware. Subject to certain exceptions, Section 203 prohibits a publicly-held Delaware corporation
from engaging in a business combination with an interested stockholder for a period of three
years after the time such person became an interested stockholder, unless the interested
stockholder attained such status with the approval of our Board of Directors or unless the business
combination is approved in a prescribed manner. A business
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combination is defined to include a merger, asset sale or other transaction resulting in a
financial benefit to the interested stockholder. Subject to various exceptions, an interested
stockholder is a person who, together with affiliates and associates, owns, or within the past
three years did own, 15% or more of a corporations voting stock. This statutory provision could
prohibit or delay the accomplishment of mergers or other takeover or change in control attempts
with respect to us and, accordingly, may discourage attempts to acquire the company.
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DESCRIPTION OF OUR WARRANTS
This description summarizes only the terms of any warrants that we may offer under this
prospectus and related warrant agreements and certificates. You should refer to the warrant
agreement, including the form of warrant certificate representing the warrants, relating to the
specific warrants being offered for complete terms, which will be described and included in an
accompanying prospectus supplement. Such warrant agreement, together with the warrant certificate,
will be filed with the SEC in connection with the offering of the specific warrants.
We may issue warrants for the purchase of common or preferred stock. Warrants may be issued
independently or together with common or preferred stock, and may be attached to or separate from
any offered securities.
We will evidence each series of warrants by warrant certificates that we will issue under a
separate warrant agreement. We may enter into the warrant agreement with a warrant agent and, if
so, we will indicate the name and address of the warrant agent in the applicable prospectus
supplement relating to the particular series of warrants.
The particular terms of any issue of warrants will be described in the prospectus supplement
relating to the series. Those terms may include:
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the title of such warrants; |
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the aggregate number of such warrants; |
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the price or prices at which such warrants will be issued; |
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the currency or currencies (including composite currencies) in which the price
of such warrants may be payable; |
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the terms of the securities issuable upon exercise of such warrants and the
procedures and conditions relating to the exercise of such warrants; |
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the price at which the securities issuable upon exercise of such warrants may be acquired; |
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the dates on which the right to exercise such warrants will commence and expire; |
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any provisions for adjustment of the number or amount of securities receivable
upon exercise of the warrants or the exercise price of the warrants; |
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if applicable, the minimum or maximum amount of such warrants that may be
exercised at any one time; |
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if applicable, the designation and terms of the securities with which such
warrants are issued and the number of such warrants issued with each such security
or principal amount of such security; |
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if applicable, the date on and after which such warrants and the related
securities will be separately transferable; |
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information with respect to book-entry procedures, if any; and |
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any other terms of such warrants, including terms, procedures and limitations
relating to the exchange or exercise of such warrants. |
The prospectus supplement relating to any warrants to purchase equity securities may also
include, if applicable, a discussion of certain U.S. federal income tax and ERISA considerations.
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The company currently does not have any outstanding warrants.
Exercise of Warrant
Each warrant will entitle its holder to purchase the number of shares of common or preferred
stock at the exercise price set forth in, or calculable as set forth in, the applicable prospectus
supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the
warrants may exercise the warrants at any time up to the expiration date set forth in the
applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void. We will specify the place or places where, and the manner in which,
warrants may be exercised in the applicable prospectus supplement. We will set forth on the
reverse side of the applicable certificate and in the applicable prospectus supplement the
information that the holder of the warrant will be required to deliver upon exercise.
Upon receipt of payment and the warrant certificate properly completed and duly executed, we
will, as soon as practicable, forward the purchased securities. If less than all of the warrants
represented by the warrant certificate are exercised, a new warrant certificate will be issued for
the remaining warrants.
Enforceability of Rights by Holders of Warrants
Each warrant agent will act solely as our agent under the applicable warrant agreement and
will not assume any obligation or relationship of agency or trust with any holder of any warrant. A
single bank or trust company may act as warrant agent for more than one issue of warrants. A
warrant agent will have no duty or responsibility in case of any default by us under the applicable
warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at
law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent
of the related warrant agent or the holder of any other warrant, enforce by appropriate legal
action its right to exercise, and receive the securities purchasable upon exercise of, such
holders warrants.
Prior to the exercise of any warrants to purchase preferred stock or common stock, holders of
the warrants will not have any of the rights of holders of the preferred stock or common stock
purchasable upon exercise, including the right to vote or to receive any payments of dividends.
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DIVIDEND POLICY
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future.
LEGAL MATTERS
Certain legal matters with respect to the securities offered hereby have been passed upon by
White White & Van Etten LLP, 55 Cambridge Parkway, Cambridge, Massachusetts 02142. David A. White,
a partner of such firm, owns 30,000 shares of our common stock.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited the consolidated
financial statements included in our Annual Report on Form 10-K/A for the year ended December 31,
2004, 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 100 F Street, N.E., Washington, D.C. 20549, or at the SECs regional
offices in Chicago, Illinois or New York, New York. 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.
The companys web site is http://www.novavax.com.
Our common stock is traded 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 securities offered by this prospectus. This prospectus, which constitutes a part of the
registration statement, does not contain all the information in the registration statement. For
further information about us and our securities, see the registration statement and its exhibits.
Statements made in this prospectus as to the content of any contract, agreement or other document
are not necessarily complete. With respect to each such contract, agreement or other document
filed as an exhibit to the registration statement, reference is made to the exhibit for a more
complete description of the matter involved, and each such statement shall be deemed qualified in
its entirety by such reference.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference in this prospectus the information in other
documents that we file with it, which means that we can disclose important information to you by
referring you to those documents containing such information. This prospectus is part of a
registration statement we filed with the SEC. You should rely on the information incorporated by
reference in this prospectus and the registration statement. The information incorporated by
reference is considered to be part of this prospectus and information we file later with the SEC
will automatically update and supersede this information and information contained in documents
filed earlier with the Commission. We incorporate by reference the documents listed below and any
future filings made with the SEC
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under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of the
offering; provided, that we are not incorporating by reference any documents or information deemed
to have been furnished and not filed in accordance with SEC rules. The documents we are
incorporating by reference are:
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Annual Report on Form 10-K/A for the fiscal year ended December 31, 2004, as filed with
the SEC on March 15, 2005; |
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Quarterly Reports on Form 10-Q for the quarters ended: |
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March 31, 2005, as filed with the SEC on May 10, 2005; |
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June 30, 2005, as filed with the SEC on August 9, 2005; and |
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September 30, 2005, as filed with the SEC on November 8, 2005; |
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Current Reports on Form 8-K filed with the SEC on March 14, 2005, March 22, 2005, April
5, 2005, July 5, 2005, July 22, 2005, August 10, 2005, August 16, 2005, September 28, 2005,
October 24, 2005, October 31, 2005, November 2, 2005, November 15, 2005 and December 8,
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Definitive Proxy Statement with respect to the Annual Meeting of Stockholders held on
May 4, 2005, as filed with the SEC on March 29, 2005; |
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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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All other reports filed by us under Section 13(a), 13(c), 14 or 15(d) of the Exchange
Act since the end of our fiscal year ended December 31, 2004. |
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., 508 Lapp Road,
Malvern, Pennsylvania 19355; (484) 913-1200. 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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