sv3
As filed with the Securities and Exchange Commission on November 22, 2006
Registration No. 333-______
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
NOVAVAX, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
(State or Other Jurisdiction of Incorporation or Organization)
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22-2816046
(I.R.S. Employer Identification Number) |
508 Lapp Road
Malvern, PA 19355
(484) 913-1200
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrants Principal Executive Offices)
Rahul Singhvi
President and Chief Executive Officer
Novavax, Inc.
508 Lapp Road
Malvern, PA 19355
(484) 913-1200
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)
With a copy to:
Jennifer L. Miller, Esq.
Ballard Spahr Andrews & Ingersoll, LLP
1735 Market Street,
51st Floor
Philadelphia, PA 19103
(215) 665-8500
Approximate date of commencement of proposed sale to the public: From time to time after
the effective date of this Registration Statement.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the
following box. o
If any of the securities being registered on this form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following box.
þ
If this form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
If this form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box. o
CALCULATION OF REGISTRATION FEE
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Proposed |
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Proposed |
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maximum |
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maximum |
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Title of each class of securities to be |
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Amount to be |
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aggregate price |
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aggregate offering |
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Amount of |
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registered |
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registered(1)(2) |
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per unit(2) |
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price(2)(3) |
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registration fee(4) |
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Common Stock, $.01 par value(5)(6) |
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Preferred stock, $.01 par value(5) |
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Warrants |
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Units |
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Total |
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$ |
100,000,000 |
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$ |
100,000,000 |
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$10,700 |
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(1) |
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There are being registered hereunder such indeterminate number of shares of common
stock and preferred stock of Novavax, Inc. (Novavax), such indeterminate number of
warrants to purchase common stock or preferred stock of Novavax, and such indeterminate
number of units consisting of any two or more of the other securities listed in the table
above and sold together as shall have an aggregate initial offering price not to exceed
$100,000,000 or the equivalent thereof in one or more currencies. |
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(2) |
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Not specified as to each class of securities to be registered hereunder pursuant to
General Instruction II.D. of Form S-3. Any securities registered hereunder may be sold
separately or as units with other securities registered hereunder. The proposed maximum
offering price per unit will be determined from time to time by the Registrant in
connection with, and at the time of, the issuance of the securities. |
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(3) |
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Estimated solely for the purpose of calculating the amount of the registration fee
required pursuant to Rule 457(o) thereof, which permits the registration fee to be
calculated on the basis of the maximum aggregate offering price of all securities listed. |
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(4) |
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An aggregate of $42,000,000 of common stock, preferred stock, warrants and units and
debt securities are being carried forward from Registration Statement No. 333-130568. In
connection with Registration Statement No. 333-130568, registration fees of $4,494
attributable to that $42,000,000 of common stock and debt securities were previously paid
and are credited against the registration fees payable in connection with this Registration
Statement. Accordingly, $6,206 is being paid in connection with this Registration
Statement. |
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(5) |
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Also includes an indeterminate number of shares of common stock that may be issued upon
conversion or exercise, as applicable, of preferred stock or warrants registered hereunder
and an indeterminate number of shares of preferred stock that may be issued upon exercise
of warrants registered hereunder. |
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(6) |
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Each share of common stock includes a right to purchase Series D Junior Participating
Preferred Stock attached to the common stock. |
PURSUANT TO RULE 429 UNDER THE SECURITIES ACT OF 1933, THIS REGISTRATION STATEMENT INCLUDES
$42,000,000 OF COMMON STOCK, PREFERRED STOCK, WARRANTS AND UNITS REGISTERED UNDER A REGISTRATION
STATEMENT ON FORM S-3 (REGISTRATION NO. 333-130568), WHICH SECURITIES HAVE NOT BEEN OFFERED OR SOLD
AS OF THE DATE OF THE FILING OF THIS REGISTRATION STATEMENT (THE PREVIOUSLY REGISTERED
SECURITIES). THIS REGISTRATION STATEMENT CONSTITUTES POST-EFFECTIVE AMENDMENT NO. 1 TO
REGISTRATION STATEMENT NO. 333-130568, PURSUANT TO WHICH THE TOTAL AMOUNT OF UNSOLD PREVIOUSLY
REGISTERED SECURITIES REGISTERED ON REGISTRATION STATEMENT NO. 333-130568 MAY BE OFFERED AND SOLD
AS SECURITIES. SUCH POST-EFFECTIVE AMENDMENTS SHALL HEREAFTER BECOME EFFECTIVE CONCURRENTLY WITH
THE EFFECTIVENESS OF THIS REGISTRATION STATEMENT AND IN ACCORDANCE WITH SECTION 8(C) OF THE
SECURITIES ACT OF 1933.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY
TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY
STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
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.
Subject to Completion, Dated November 22, 2006
PROSPECTUS
$100,000,000
Common Stock
Preferred Stock
Warrants
We may issue and sell from time to time our common stock, preferred stock, warrants
and/or units consisting of two or more of any such securities on terms to be determined at the time
of sale. The preferred stock may be convertible into shares of our common stock and the warrants
may be exercisable for shares of our common stock or shares of our preferred stock. We may offer
these securities separately or together in one or more offerings with a maximum aggregate offering
price of $100,000,000.
We will provide a prospectus supplement each time we issue securities, specifying the specific
terms of the securities being sold as well as the specific terms of that offering.
You should read this prospectus and any prospectus supplement, including any information
incorporated herein and therein, carefully before you invest.
The securities being sold may be sold on a delayed or continuous basis directly by us, through
dealers, agents or underwriters designated from time to time, or through any combination of these
methods. If any dealers, agents or underwriters are involved in the sale of the securities in
respect of which this prospectus is being delivered, we will disclose their names and the nature of
our arrangements with them in any prospectus supplement. The net proceeds we expect to receive
from any such sale will also be included in the applicable prospectus supplement.
Our common stock is traded on the NASDAQ Global Market under the symbol NVAX. On November 20,
2006, the closing price of our common stock as reported on the NASDAQ Global Market was $5.28 per
share. None of the other securities offered under this prospectus are publicly traded.
Investing in our securities involves a high degree of risk. See RISK FACTORS beginning on page 4.
This prospectus may not be used to offer or sell securities unless accompanied by a prospectus
supplement for the securities being sold.
Neither the Securities and Exchange Commission nor any other regulatory body has approved or
disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any
representation to the contrary is a criminal offense.
The date of this Prospectus is , 2006.
TABLE OF CONTENTS
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Page |
Novavax, Inc. |
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3 |
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Risk Factors |
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4 |
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About this Prospectus |
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Special Note Regarding Forward-Looking Statements |
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Use of Proceeds |
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Plan of Distribution |
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Description of Our Capital Stock |
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19 |
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Description of Our Warrants |
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Description of Our Units |
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Dividend Policy |
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Legal Matters |
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Experts |
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Where You Can Find More Information |
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Incorporation of Certain Information by Reference |
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You should rely only on the information contained in this prospectus and in any prospectus
supplement (including in any documents incorporated by reference herein or therein). We have not
authorized anyone to provide you with any different information. We are offering to sell our
securities, and seeking offers to buy, only in jurisdictions where offers and sales are permitted.
The information contained in this prospectus and any prospectus supplement is accurate only as of
the date of this prospectus or such prospectus supplement, and the information contained in any
document incorporated herein or therein by reference is accurate only as of the date of such
document incorporated by reference, regardless of the time of delivery or any sale of our
securities.
In this prospectus, we, us, our and the company refer to Novavax, Inc., together with
its subsidiary, unless the context otherwise requires.
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NOVAVAX, INC.
Novavax, Inc., a Delaware corporation, was incorporated in 1987, and is a biopharmaceutical
company focused on creating differentiated, value-added vaccines that leverage the companys
proprietary virus-like particle (VLP) technology utilizing the baculovirus expression system in
insect cells, as well as developing novel vaccine adjuvants based on Novasomes®. VLPs
imitate the three-dimensional structures of viruses but are composed of recombinant proteins and,
therefore, are believed incapable of causing infection and disease. Our proprietary production
technology uses insect cells rather than chicken eggs or mammalian cells. We believe that this
allows the company to more rapidly produce safe, effective, low-cost and therapeutic proteins. We
are developing vaccines against the H5N1, H9N2 and other subtypes of avian influenza with pandemic
potential and against human seasonal influenza as well as other viral diseases.
We have also developed a drug delivery platform using micellar nanoparticle (MNP)
technology, proprietary oil and water nanoemulsions used for the tropical delivery of drugs, which
was the basis for the development of its first Food and Drug Administration-approved product,
ESTRASORB®, which is a topical emulsion for estrogen therapy. In October 2005, we
entered into a License Agreement and a Supply Agreement for ESTRASORB with Esprit Pharma, Inc.
(Esprit). Under the agreements, we will continue to manufacture ESTRASORB and the licensee,
Esprit, was granted an exclusive license to sell ESTRASORB in North America. In April 2006, we
entered into a License and Development Agreement and a Supply Agreement with Esprit to co-develop,
supply and commercialize our MNP testosterone product candidate for the treatment of female
hypoactive sexual desire disorder. Esprit was granted exclusive rights to market the product in
North America.
Our strategy is to develop new product candidates based on our drug delivery technologies and
to co-promote or license such products. We intend to use the cash generated by such arrangements
primarily to fund our avian and seasonal flu vaccine programs, which we believe are our long-term
growth drivers.
Our principal executive offices are located at 508 Lapp Road, Malvern, Pennsylvania 19355. Our
telephone number is (484) 913-1200 and our Internet address is www.novavax.com.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider
the following risk factors and all other information contained in this prospectus and any
accompanying prospectus supplement as well as other information we incorporate by reference in this
prospectus and any accompanying prospectus supplement. The risks and uncertainties described below
are not the only ones facing us. Additional risks and uncertainties that we are unaware of, or that
we currently deem immaterial, also may become important factors that affect us. If any of the
following risks occur, our business, financial condition or results of operations could be
materially and adversely affected. In that case, the value of our securities could decline, and you
may lose some or all of your investment.
RISKS RELATED TO OUR BUSINESS
We have repositioned ourselves from a specialty biopharmaceutical company to a biopharmaceutical
company and face all the risks inherent in the implementation of a new business strategy.
In conjunction with the sale of our prenatal and related product lines and the grant of an
exclusive North American license to our lead product ESTRASORB during the second half of 2005, we have changed the focus of the
company from the development and commercialization of specialty pharmaceutical products to the
research and development of new products using our proprietary drug delivery and biological
platforms. We cannot predict whether we will be successful in implementing our new business
strategy.
We intend to focus our research and development activities on areas in which we have
particular strengths and on technologies that appear promising. These technologies often are on
the cutting edge of modern science. As a result, the outcome of any research or development
program is highly uncertain. Only a very small fraction of these programs ultimately result in
commercial products or even product candidates and a number of events could delay our development
efforts and negatively impact our ability to obtain regulatory approval for, and to market and
sell, a product candidate. Product candidates that initially appear promising often fail to yield
successful products. In many cases, preclinical or clinical studies will show that a product
candidate is not efficacious or that it raises safety concerns or has other side effects that
outweigh the intended benefit. Success in preclinical or early clinical trials may not translate
into success in large-scale clinical trials. Further, success in clinical trials will likely lead
to increased investment, adversely affecting short-term profitability, to bring such products to
market. Even after a product is approved and launched, general usage or post-marketing studies may
identify safety or other previously unknown problems with the product, which may result in
regulatory approvals being suspended, limited to narrow indications or revoked, or which may
otherwise prevent successful commercialization.
We must identify products and product candidates for development with our technologies and
establish successful government and third-party relationships.
Our long-term ability to generate product-related revenue depends in part on our ability to
identify products and product candidates that may utilize our drug delivery and biological
technologies. If internal efforts do not generate sufficient product candidates, we will need to
identify third parties that wish to license our technologies for development of their products or
product candidates. We may be unable to license our technologies to third parties for a number of
reasons, including:
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an inability to negotiate license terms that would allow us to make an appropriate
return from resulting products; |
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an inability to identify suitable products or product candidates within, or
complementary to, our areas of expertise; or |
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an unwillingness on the part of competitors to utilize the technologies of a competing
company or disclose the existence or status of new products or products candidates under
development. |
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Our near and long-term viability will also depend in part on our ability to successfully
establish new strategic collaborations with pharmaceutical and biotechnology companies and
government agencies. Establishing strategic collaborations and obtaining government funding are
difficult and time-consuming. Potential collaborators may reject collaborations based upon their
assessment of our financial, regulatory or intellectual property position; government agencies may
reject contract or grant applications based on their assessment of public need, the public interest
and our products ability to address these areas. If we fail to establish a sufficient number of
collaborations or government relationships on acceptable terms, we may not generate sufficient
revenue.
Even if we successfully establish new collaborations or obtain government funding, these
relationships may never result in the successful development or commercialization of any product
candidates or the generation of any sales or royalty revenue. Reliance on such relationships also
exposes us to a number of risks. We may not have the ability to control the activities of our
partners and cannot assure you that they will fulfill their obligations to us, including with
respect to the license, development and commercialization of products and product candidates, in a
timely manner or at all. We cannot assure you that such partners will devote sufficient resources
to our products and product candidates or properly maintain or defend our intellectual property
rights; we also can give no assurances that our partners will not utilize such rights in such a way
as to invite or cause litigation. Any failure on the part of our partners to perform or satisfy
their obligations to us could lead to delays in the development or commercialization of products
and product candidates, and affect our ability to realize product revenues. Disagreements,
including disputes over the ownership of technology developed with such collaborators, could result
in litigation, which would be time-consuming and expensive, and may delay or terminate research and
development efforts, regulatory approvals, and commercialization activities. If we or our partners
fail to maintain our existing agreements or in the event we fail to establish agreements as
necessary, we could be required to undertake research, development, manufacturing and
commercialization activities solely at our own expense. These activities would significantly
increase our capital requirements and, given our current limited sales, marketing and distribution
capabilities, significantly delay the commercialization of products and product candidates.
Our success depends on our ability to maintain the proprietary nature of our technology.
Our success in large part depends on our ability to maintain the proprietary nature of our
technology and other trade secrets, including our proprietary drug delivery and biological
technologies. To do so, we must prosecute and maintain existing patents, obtain new patents and
pursue trade secret and other intellectual property protection. We also must operate without
infringing the proprietary rights of third parties or letting third parties infringe our rights. We
currently have over fifty U.S. patents and corresponding foreign patents and patent applications
covering our technologies. However, patent issues relating to pharmaceuticals involve complex
legal, scientific and factual questions. To date, no consistent policy has emerged regarding the
breadth of biotechnology patent claims that are granted by the U.S. Patent and Trademark Office or
enforced by the federal courts. Therefore, we do not know whether our patent applications will
result in the issuance of patents, or that any patents issued to us will provide us with any
competitive advantage. We also cannot be sure that we will develop additional proprietary products
that are patentable. Furthermore, there is a risk that others will independently develop or
duplicate similar technology or products or circumvent the patents issued to us.
There is a risk that third parties may challenge our existing patents or claim that we are
infringing their patents or proprietary rights. We could incur substantial costs in defending
patent infringement suits or in filing suits against others to have their patents declared invalid
or claim infringement. It is also possible that we may be required to obtain licenses from third
parties to avoid infringing third-party patents or other proprietary rights. We cannot be sure that
such third-party licenses would be available to us on acceptable terms, if at all. If we are unable
to obtain required third-party licenses, we may be delayed in or prohibited from developing,
manufacturing or selling products requiring such licenses.
Although our patents include claims covering various features of our products and product
candidates, including composition, methods of manufacture and use, our patents do not provide us
with complete protection against the development of competing products. Some of our know-how and
technology is not patentable. To protect our proprietary rights in unpatentable intellectual
property and trade secrets, we require employees, consultants, advisors and collaborators to enter
into confidentiality agreements. These agreements may not provide meaningful protection for our
trade secrets, know-how or other proprietary information in the event of any unauthorized use or
disclosure.
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We have limited financial resources and we are not certain that we will be able to obtain financing
to maintain our operations or to fund the development of future products.
Over the next few years we may not generate revenues from product sales, licensing fees,
royalties, milestones, contract research and other sources in an amount sufficient to fund our
operations, and we will therefore use our cash resources and could require additional funds to
maintain our operations, continue our research and development programs, commence future
preclinical and clinical trials, seek regulatory approvals and market our products. We will seek
such additional funds through public or private equity or debt financings, collaborative
arrangements and other sources. We cannot be certain that adequate additional funding will be
available to us on acceptable terms, if at all. If we cannot raise the additional funds required
for our anticipated operations, we may be required to delay significantly, reduce the scope of or
eliminate one or more of our research or development programs, downsize our general and
administrative infrastructure or programs, or seek alternative measures to avoid insolvency,
including arrangements with collaborative partners or others that may require us to relinquish
rights to certain of our technologies, product candidates or products. If we raise additional funds
through future offerings of shares of our common stock or other securities, such offerings would
cause dilution of existing stockholders percentage ownership in the company. These future
offerings also could have a material and adverse effect on the price of our common stock.
We have a history of losses and our future profitability is uncertain.
Our expenses have exceeded our revenues since our formation in 1987, and our accumulated
deficit at September 30, 2006 was $158.8 million. Our net revenues for the last three fiscal years
were $7.4 million in 2005, $8.3 million in 2004 and $11.8 million in 2003. For the nine months
ended September 30, 2006 and 2005, our revenues were $3.3 million and $5.1 million, respectively.
We have received a limited amount of product-related revenue from research contracts, licenses and
agreements to provide vaccine products, services and adjuvant technologies. We cannot be certain
that we will be successful in entering into strategic alliances or collaborative arrangements with
other companies that will result in other significant revenues to offset our expenses. Our net
losses for the last three fiscal years were $11.2 million in 2005, $25.9 million in 2004 and $17.3
million in 2003, while they were $16.9 million and $17.3 million for the nine months ended
September 30, 2006 and 2005, respectively.
Our losses have resulted from research and development expenses, sales and marketing expenses
for ESTRASORB, protection of our intellectual property and other general operating expenses. Our
losses increased due to the launch of ESTRASORB as we expanded our manufacturing capacity and sales
and marketing capabilities, and may increase as and when we conduct additional and larger clinical
trials for our product candidates. Our losses have also increased, and may continue to increase, as
a result of ramped-up research and development efforts to support our development of flu vaccines.
Therefore, we expect our cumulative operating loss to increase until such time, if ever, product
sales, licensing fees, royalties, milestones, contract research and other sources generate
sufficient revenue to fund our continuing operations. We cannot predict when, if ever, we might
achieve profitability and cannot be certain that we will be able to sustain profitability, if
achieved.
Many of our competitors have significantly greater resources and experience, which may negatively
impact our commercial opportunities and those of our current and future licensees.
The biotechnology and pharmaceutical industries are subject to intense competition and rapid
and significant
technological change. We have many potential competitors, including major drug and chemical
companies,
specialized biotechnology firms, academic institutions, government agencies and private and public
research
institutions. Many of our competitors have significantly greater financial and technical resources,
experience and
expertise in:
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research and development; |
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pre-clinical testing; |
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clinical trials; |
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regulatory processes and approvals; |
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production and manufacturing; and |
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sales and marketing of approved products. |
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Large and established companies such as Merck & Co., Inc., GlaxoSmithKline PLC, Novartis, Inc.
and MedImmune Inc., among others, compete in the vaccine market. In particular, these companies
have greater experience and expertise in securing government contracts and grants to support their
research and development efforts, conducting testing and trials, obtaining regulatory approvals to
market products, and manufacturing such products on a broad scale.
Smaller or early-stage companies and research institutions may also prove to be significant
competitors, particularly through collaborative arrangements with large and established
pharmaceutical or other companies. We will also face competition from these parties in recruiting
and retaining qualified scientific and management personnel, establishing clinical trial sites and
patient registration for clinical trials, and in acquiring and in-licensing technologies and
products complementary to our programs or potentially advantageous to our business. If any of our
competitors succeeds in obtaining approval from the Food and Drug
Administration (the FDA) or
other regulatory authorities for their products sooner than we do or for products that are more
effective or less costly than ours, our commercial opportunity could be significantly reduced.
In order to effectively compete, we will have to make substantial investments in sales and
marketing or partner with one or more established companies. There is no assurance that we will be
successful in gaining significant market share for any product or product candidate. Our
technologies and products also may be rendered obsolete or noncompetitive as a result of products
introduced by our competitors to the marketplace more rapidly and at a lower cost.
The return on our investment in ESTRASORB depends in large part on the success of our relationship
with Esprit and our ability to manufacture the product.
In October 2005, we entered into a License Agreement and a Supply Agreement with Esprit Pharma
for ESTRASORB. Under the License Agreement, we granted Esprit exclusive rights to market ESTRASORB
in North America. In consideration for such rights, Esprit paid us $12.5 million during the first
year. Novavax is also entitled to receive a royalty on all net sales of ESTRASORB as well as
sales-based milestone payments.
While our License Agreement with Esprit gives us some limited protections with respect to that
companys ESTRASORB marketing and sales efforts and, we believe, creates incentives for Esprit
consistent with our own, we cannot control the amount and timing of the marketing efforts that
Esprit devotes to ESTRASORB or make any assurances that Esprits promotion and marketing of
ESTRASORB in North America will be successful. We do not have a history of working together with
Esprit and cannot predict the success of the collaboration, nor can we give any assurances that
Esprit will not reduce or curtail its efforts to market ESTRASORB because of factors affecting its
business or operations beyond our control. Loss of Esprit as a partner in the commercialization of
ESTRASORB, any dispute over the terms of or decisions regarding the License and Supply Agreements,
or other adverse developments in our relationship with Esprit may harm our business and might
accelerate our need for additional capital. We also can give no assurances that Esprit will be
more successful than us in gaining market acceptance of ESTRASORB. Prescription trends for
ESTRASORB have not met our expectations to date and Esprit will face similar obstacles to gaining
market share of the estrogen therapy market, including competition from large and established
companies with similar estrogen therapy products.
Numerous companies worldwide currently produce and sell estrogen products for clinical
indications identical to those for ESTRASORB. Currently, the oral and patch product segments
account for approximately 75% and 15% of the market, respectively, according to 2004 Verispan data.
Wyeth commits significant resources to the sale and marketing of its product,
Premarin®, in order to maintain its market leadership position. Several other companies
compete in the estrogen category including Berlex Laboratories, Inc., Novartis Pharma AG and Solvay
Pharmaceuticals. In particular, Solvay has introduced an alcohol-based gel product, Estrogel,
which is directly
competitive with ESTRASORB. These and other products sold by our competitors have all
achieved a degree of market penetration superior to ESTRASORB.
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In addition, under the Supply Agreement, we are obligated to supply Esprit with ESTRASORB
through the manufacture of the product at our manufacturing facility in Philadelphia, Pennsylvania.
We have only limited experience with the large capacity manufacturing required for the commercial
sale of a product. Although we have validated our manufacturing methods for the product with the
FDA, we will remain subject to that agencys rules and regulations regarding good manufacturing
practices, which are enforced by the FDA through its facilities inspection program. Compliance
with such rules and regulations requires us to spend substantial funds and hire and retain
qualified personnel. We face the possibility that we may not be able to meet Esprits supply
requirements under the agreement in a timely fashion at acceptable quality, quantity and prices or
in compliance with applicable regulations. If our facility fails to comply with applicable
regulations, we will be forced to utilize a third party contractor to manufacture the product. We
may not be able to enter into alternative manufacturing arrangements at commercially acceptable
rates, if at all. Moreover, the manufacturers we use may not provide sufficient quantities of
product to meet our specifications or our delivery, cost and other requirements.
We must utilize our manufacturing facility for products other than ESTRASORB in order to avoid
operating the facility at a loss.
Currently we are manufacturing ESTRASORB at our facility in Philadelphia, Pennsylvania and it
is likely we will continue to manufacture ESTRASORB at a loss until production volumes increase or
we enter into additional contract manufacturing agreements with third parties to more fully utilize
our manufacturing facilitys capacity. The facility is able to accommodate much greater production
than its current schedule, which, if more fully utilized, would offset the fixed costs related to
the manufacturing process and facility. In addition, we are negotiating revisions to our agreements
for packaging costs of ESTRASORB as well as our fixed lease costs for the manufacturing facility.
If these negotiations result in higher packaging or lease costs for us, it may have a material
adverse impact on future financial results.
We have not completed the development of products other than ESTRASORB and we may not succeed in
obtaining the FDA approval necessary to sell additional products.
The development, manufacture and marketing of our pharmaceutical and biological products are
subject to government regulation in the United States and other countries. In the United States
and most foreign countries, we must complete rigorous preclinical testing and extensive human
clinical trials that demonstrate the safety and efficacy of a product in order to apply for
regulatory approval to market the product. ESTRASORB is the only product developed by the company
to have been approved for sale in the United States. Approval outside the U.S. may take longer or
may require additional clinical trials. We have product candidates in preclinical laboratory or
animal studies.
Before applying for FDA approval to market any new drug product candidates, we must first
submit an Investigational New Drug application (an IND) that explains to the FDA the results of
pre-clinical testing conducted in laboratory animals and what we propose to do for human testing.
At this stage, the FDA decides whether it is reasonably safe to move forward with testing the drug
on humans. We must then conduct Phase I studies and larger-scale Phase II and III human clinical
trials that demonstrate the safety and efficacy of our products to the satisfaction of the FDA.
Once these trials are complete, a New Drug Application (an NDA) can be filed with the FDA
requesting approval of the drug for marketing.
Vaccine clinical development follows the same general pathway as for drugs and other
biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an IND
describing the vaccine, its method of manufacture and quality control tests for release.
Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases. Initial
human studies, referred to as Phase I, are safety and immunogenicity studies performed in a small
number of closely monitored subjects. Phase II studies are dose-ranging studies and may enroll
hundreds of subjects. Finally, Phase III trials typically enroll thousands of individuals and
provide the critical documentation of effectiveness and important additional safety data required
for licensing.
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If successful, the completion of all three phases of clinical development can be followed by
the submission of a Biologics License Application (a BLA). Also during this stage, the proposed
manufacturing facility undergoes a pre-approval inspection during which production of the vaccine
as it is in progress is examined in detail. Vaccine approval also requires the provision of
adequate product labeling to allow health care providers to understand the vaccines proper use,
including its potential benefits and risks, to communicate with patients and parents, and to safely
deliver the vaccine to the public. Until a vaccine is given to the general population, all
potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase IV studies after
a BLA has been approved and the vaccine is licensed and on the market.
These processes are expensive and can take many years to complete, and we may not be able to
demonstrate the safety and efficacy of our products to the satisfaction of such regulatory
authorities. Regulatory authorities may also require additional testing and we may be required to
demonstrate that our proposed products represent an improved form of treatment over existing
therapies, which we may be unable to do so without conducting further clinical studies. Moreover,
if the FDA grants regulatory approval of a product, the approval may be limited to specific
indications or limited with respect to its distribution. Expanded or additional indications for
approved drugs may not be approved, which could limit our revenues. Foreign regulatory authorities
may apply similar limitations or may refuse to grant any approval. Consequently, even if we
believe that preclinical and clinical data are sufficient to support regulatory approval for our
product candidates, the FDA and foreign regulatory authorities may not ultimately grant approval
for commercial sale in any jurisdiction. If our drug candidates are not approved, our ability to
generate revenues may be limited and our business will be adversely affected.
We may fail to obtain regulatory approval for our products on a timely basis or comply with our
continuing regulatory obligations after approval is obtained.
Delays in obtaining regulatory approval can be extremely costly in terms of lost sales
opportunities and increased clinical trial costs. The speed with which we complete our clinical
trials and our applications for marketing approval will depend on several factors, including the
following:
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the rate of patient enrollment and retention, which is a function of many factors,
including the size of the patient population, the proximity of patients to clinical sites,
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Institutional Review Board approval of the protocol and the informed consent form; |
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prior regulatory agency review and approval; |
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our ability to manufacture or obtain sufficient quantities of materials for use in clinical trials; |
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negative test results or side effects experienced by trial participants; |
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analysis of data obtained from preclinical and clinical activities, which are
susceptible to varying interpretations and which interpretations could delay, limit or
prevent regulatory approval; |
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changes in the policies of regulatory authorities for drug or vaccine approval during
the period of product development; and |
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the availability of skilled and experienced staff to conduct and monitor clinical
studies and to prepare the appropriate regulatory applications. |
We have limited experience in conducting and managing the preclinical and clinical trials
necessary to obtain regulatory marketing approvals. We may not be able to obtain the approvals
necessary to conduct clinical studies. We also face the risk that the results of our clinical
trials may be inconsistent with the results obtained in preclinical studies or that the results
obtained in later phases of clinical trials may be inconsistent with those obtained in earlier
phases. A number of companies in the specialty biopharmaceutical and product development industry
have suffered significant setbacks in advanced clinical trials, even after experiencing promising
results in early animal and human
testing. If regulatory approval of a drug is granted, such approval is likely to limit the
indicated uses for which it may be marketed.
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Furthermore, even if a product gains regulatory approval, the product and the manufacturer of
the product will be subject to continuing regulatory review, including adverse event reporting
requirements and the FDAs general prohibition against promoting products for unapproved uses.
Failure to comply with any post-approval requirements can, among other things, result in warning
letters, product seizures, recalls, fines, injunctions, suspensions or revocations of marketing
licenses, operating restrictions and criminal prosecutions. Any of these enforcement actions, any
unanticipated changes in existing regulatory requirements or the adoption of new requirements, or
any safety issues that arise with any approved products, could adversely affect our ability to
market products and generate revenues and thus adversely affect our ability to continue our
business.
We also may be restricted or prohibited from marketing or manufacturing a product, even after
obtaining product approval, if previously unknown problems with the product or its manufacture are
subsequently discovered and we cannot assure you that newly discovered or developed safety issues
will not arise following any regulatory approval. With the use of any drug by a wide patient
population, serious adverse events may occur from time to time that initially do not appear to
relate to the drug itself, and only if the specific event occurs with some regularity over a period
of time does the drug become suspect as having a causal relationship to the adverse event. Any
safety issues could cause us to suspend or cease marketing of our approved products, possibly
subject us to substantial liabilities, and adversely affect our ability to generate revenues and
our financial condition.
Our substantial indebtedness could adversely affect our cash flow and prevent us from fulfilling
our obligations.
As of September 30, 2006, we had $22.7 million of outstanding indebtedness. Our substantial
amount of outstanding indebtedness could have significant consequences. For example, it:
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requires us to dedicate a substantial portion of our cash flow from operations to
service payments on our indebtedness, reducing the availability of our cash flow to fund
future capital expenditures, working capital, execution of our growth strategy, research
and development costs and other general corporate requirements; |
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could limit our flexibility in planning for, or reacting to, changes in our business and
the industry, which may place us at a competitive disadvantage compared with competitors
that have less indebtedness; and |
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could limit our ability to obtain additional funds, even when necessary to maintain
adequate liquidity. |
We may incur additional indebtedness for various reasons, which would increase the risks
associated with our substantial leverage.
Health care insurers and other payors may not pay for our products or may impose limits on
reimbursement.
Our ability and the ability of our licensees to successfully commercialize ESTRASORB and
future products will depend, in part, on the extent to which reimbursement for such products will
be available from third-party payors such as Medicare, Medicaid, health maintenance organizations,
health insurers and other public and private payors. If we succeed in bringing products to the
market, we cannot be assured that third-party payors will pay for such products or establish and
maintain price levels sufficient for realization of an appropriate return on our investment in
product development. For example, ESTRASORB currently is being sold as an outpatient prescription
drug. Medicare does not cover the costs of most outpatient prescription drugs. We expect that over
time ESTRASORB will be treated the same as other estrogen therapy products with respect to
government and third-party payor reimbursement, however, additional time is required to increase
the number of payors who currently accept our product for reimbursement. There can be no assurance
that ESTRASORB will receive similar reimbursement treatment.
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Many health maintenance organizations and other third-party payors use formularies, or lists
of drugs for which
coverage is provided under a health care benefit plan, to control the costs of prescription
drugs. Each payor that maintains a drug formulary makes its own determination as to whether a new
drug will be added to the formulary and whether particular drugs in a therapeutic class will have
preferred status over other drugs in the same class. This determination often involves an
assessment of the clinical appropriateness of the drug and, in some cases, the cost of the drug in
comparison to alternative products. There can be no assurance that ESTRASORB or any of our future
products will be added to payors formularies, that our products will have preferred status to
alternative therapies, or that the formulary decisions will be conducted in a timely manner. We may
also decide to enter into discount or formulary fee arrangements with payors, which could result in
us receiving lower or discounted prices for ESTRASORB or future products.
We may have product liability exposure.
The administration of drugs to humans, whether in clinical trials or after marketing
clearances are obtained, can result in product liability claims. We maintain product liability
insurance coverage in the total amount of $10.0 million for claims arising from the use of our
currently marketed products and products in clinical trials prior to FDA approval. Coverage is
becoming increasingly expensive, however, and we may not be able to maintain insurance at a
reasonable cost. There can be no assurance that we will be able to maintain our existing insurance
coverage or obtain coverage for the use of our other products in the future. This insurance
coverage and our resources may not be sufficient to satisfy liabilities resulting from product
liability claims. A successful claim may prevent us from obtaining adequate product liability
insurance in the future on commercially desirable terms, if at all. Even if a claim is not
successful, defending such a claim would be time-consuming and expensive, may damage our reputation
in the marketplace, and would likely divert managements attention.
We have made loans to certain of our directors, which could have a negative impact on our stock
price.
In 2002, pursuant to our 1995 Stock Option Plan, we approved the payment of the exercise price
of options by two of our directors through the delivery of full-recourse, interest-bearing
promissory notes in the aggregate principal amount of approximately $1.5 million, secured by a
pledge of the underlying shares. As of September 30, 2006, accrued interest receivable related to
the borrowing was $340,000. Due to heightened sensitivity in the current environment surrounding
related-party transactions, these transactions could be viewed negatively in the market and our
stock price could be negatively affected. Our corporate governance policies have been revised and
our 2005 Stock Incentive Plan prohibits any additional loans or guarantees to directors.
RISKS RELATED TO OUR SECURITIES
The price of our common stock has been and may continue to be volatile.
Historically, the market price of our common stock has fluctuated over a wide range. In
fiscal year 2005, our common stock traded in a range from $0.70 to $6.01. Between January 1, 2006
and November 20, 2006, our common stock traded in a range from $2.84 to $8.39. It is likely that
the price of our common stock will fluctuate in the future. The market prices of securities of
small-capitalization, biopharmaceutical companies, including ours, from time to time experience
significant price and volume fluctuations unrelated to the operating performance of these
companies. In particular, the market price of our common stock may fluctuate significantly due to a
variety of factors, including:
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governmental agency actions including the FDAs determination with respect to new drug
applications for new products; |
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our ability to obtain financing; |
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our ability to obtain government contracts to develop vaccines and other biological
products and technologies; and |
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our ability to develop additional products, including biologicals and vaccines. |
In addition, the occurrence of any of the risks described in these Risk Factors could have a
material and
adverse impact on the market price of our common stock.
- 11 -
The conversion of our outstanding convertible debt, and the issuance of shares of our common stock
upon conversion or exercise of preferred stock and/or warrants or in future offerings would cause
dilution of existing security holders interests in the company and may cause the price of our
common stock to go down.
As of September 30, 2006, we had outstanding convertible notes in the aggregate principal
amount of $22,000,000 that as of such date were convertible into an aggregate of 4,029,304 shares
of our common stock. The issuance of shares of our common stock upon conversion of such notes, as
well as in connection with future capital raising activities, would cause immediate and potentially
substantial equity dilution for existing stockholders and the price of our common stock could be
subject to significant downward pressure.
We have never paid dividends on our capital stock, and we do not anticipate paying any such
dividends in the foreseeable future.
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future. In addition, the terms of our existing and any
future debt may preclude us from paying dividends. As a result, capital appreciation, if any, of
our common stock would be the only source of gain for stockholders until dividends are permitted
and paid.
Provisions of our Certificate of Incorporation and By-laws, Delaware law, and our Shareholder
Rights Plan could delay or prevent the acquisition of the company, even if such acquisition would
be beneficial to stockholders, and could impede changes in our Board.
Provisions of Delaware corporate law and our organizational documents could hamper a third
partys attempt to acquire, or discourage a third party from attempting to acquire control of, the
company. Moreover, our shareholder rights plan empowers our Board to delay or negotiate, and
thereby possibly thwart, any tender offer or takeover attempt the Board opposes. Stockholders who
wish to participate in these transactions may not have the opportunity to do so. These provisions
also could limit the price investors are willing to pay in the future for our securities and make
it more difficult to change the composition of our Board in any one year. These provisions include
the right of the Board to issue preferred stock with rights senior to those of the common stock
without any further vote or action by stockholders, the existence of a staggered Board with three
classes of directors serving staggered three-year terms, advance notice requirements for
stockholders to nominate directors and make proposals, and a Delaware statutory provision
prohibiting certain transactions between Novavax and interested stockholders.
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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, as described in Where You Can Find More Information.
You should rely only on the information contained in this prospectus and in any prospectus
supplement (including in any documents incorporated by reference herein or therein). We have not
authorized anyone to provide you with any different information. We are offering to sell our
securities, and seeking offers to buy, only in jurisdictions where offers and sales are permitted.
The information contained in this prospectus and any prospectus supplement is accurate only as of
the date of this prospectus or such prospectus supplement, and the information contained in any
document incorporated herein or therein by reference is accurate only as of the date of such
document incorporated by reference, regardless of the time of delivery or any sale of our
securities.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus and any accompanying prospectus supplement (including any
documents incorporated by reference herein or therein) contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on
managements beliefs and assumptions and on information currently available, and use words such as
expect, anticipate, intend, plan, believe, estimate, may, could, possible,
forecast, or similar words and expressions. Forward-looking statements include but are not
limited to statements regarding usage of cash, product sales, future product development and
related clinical trials, and future research and development, including FDA approval of our product
candidates. Forward-looking statements are only predictions, and necessarily involve risks and
uncertainties and other factors that may cause the actual results, performance or achievements of
Novavax, or industry results, to be materially different from those anticipated in or implied by
the forward-looking statements. These risks, uncertainties and other factors are discussed in the
Risk Factors section and elsewhere in this prospectus and any accompanying prospectus supplement
(including any documents incorporated by reference herein or therein) and include, among other
things, the following:
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general economic and business conditions; |
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ability to enter into future collaborations with industry partners; |
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competition; |
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unexpected changes in technologies and technological advances; |
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ability to obtain rights to technology; |
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ability to obtain and enforce patents; |
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ability to commercialize and manufacture products; |
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ability to maintain commercial-scale manufacturing capabilities; |
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results of clinical studies; |
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progress of research and development activities; |
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business abilities and judgment of personnel; |
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availability of qualified personnel; |
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changes in, or failure to comply with, governmental regulations; |
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ability to obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity financings or otherwise; and |
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other factors referenced in this prospectus and any accompanying prospectus
supplement (including any documents incorporated by reference herein or therein). |
We undertake no obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise. You are advised, however, to consult any
further disclosures we make on related subjects in our 10-Q, 8-K and 10-K reports to the SEC.
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USE OF PROCEEDS
Except as otherwise described in an applicable prospectus supplement, we currently intend to
use the net proceeds from this offering for general corporate purposes, which may include:
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clinical development of VLP-based avian and seasonal flu vaccines, including the
development of appropriate adjuvants, and demonstration of large-scale production
capabilities, for such vaccines; |
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our internal research and development programs, such as preclinical and clinical
testing and studies of our product candidates and the development of new
technologies; |
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expansion of and investment in our research and development facilities,
including compliance with current Good Manufacturing Practices (cGMP)
and Good Laboratory Practices (GLP) rules and regulations; and |
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general working capital. |
Each time we issue securities, we will provide a prospectus supplement that will contain
information about how we intend to use the proceeds from each such offering.
At this time, we have not determined the specific uses of any offering proceeds, or the
amounts we plan to spend on any particular use or the timing of such expenditures, which may vary
significantly depending on various factors such as our research and development results, regulatory
approvals, competition, marketing and sales, and the market acceptance of any products introduced
by us or our partners. Pending application of the net proceeds from any particular offering, we
intend to invest such proceeds in short-term, interest-bearing, investment-grade securities.
We cannot guarantee that we will receive any proceeds in connection with any offering
hereunder because we may choose not to issue any of the securities covered by this prospectus.
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PLAN OF DISTRIBUTION
We may sell the securities being offered hereby from time to time in one or more of the
following ways:
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through one or more underwriters, |
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through dealers, who may act as agents or principal (including a block trade in
which a broker or dealer so engaged will attempt to sell the shares as agent but
may position and resell a portion of the block as principal to facilitate the
transaction), |
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directly to one or more purchasers, |
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through agents, |
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in privately negotiated transactions, and |
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in any combination of these methods of sale. |
We will set forth in a prospectus supplement the terms of the offering of securities, including:
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the name or names of any agents, underwriters or dealers, |
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the terms of the securities being offered, including the purchase price and the
proceeds we will receive from the sale, |
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any underwriting discounts and commissions or agency fees and other items
constituting underwriters or agents compensation, |
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any over-allotment options under which underwriters may purchase additional
securities from us, and |
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any discounts or concessions allowed or reallowed or paid to dealers. |
The distribution of the securities may be effected from time to time in one or more
transactions at a fixed price or prices, which may be changed, at market prices prevailing at the
time of sale, at prices related to the prevailing market prices, or at negotiated prices.
Underwriters, dealers, agents and others that participate in the distribution of the
securities may be underwriters as defined in the Securities Act of 1933, as amended (the
Securities Act) and any discounts or commissions they receive from us and any profit on their
resale of the securities may be treated as underwriting discounts and commissions under the
Securities Act. We will identify in the applicable prospectus supplement any underwriters,
dealers, agents and others and will describe their compensation. We may have agreements with
underwriters, dealers, agents and others to indemnify them against specified civil liabilities,
including liabilities under the Securities Act. Underwriters, dealers, agents and others may
engage in transactions with or perform services for us in the ordinary course of their businesses.
We have not entered into any agreements, understandings or arrangements with any underwriters,
broker-dealers or other parties regarding the sale of securities. As of the date of this
prospectus, there were no special selling arrangements between any broker-dealer or other person
and the company. No period of time has been fixed within which the securities will be offered or
sold.
If required under applicable state securities laws, we will sell the securities only through
registered or licensed brokers or dealers. In addition, in some states, we may not sell securities
unless they have been registered or qualified for sale in the applicable state or unless we have
complied with an exemption from any registration or qualification requirements.
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Agents
We may designate agents who agree to solicit purchases for the period of their appointment or
to sell securities on a continuing basis. Unless the prospectus supplement provides otherwise,
agents will act on a best efforts basis for the period of their appointment. Agents may receive
compensation in the form of commissions, discounts or concessions from us. Agents may also receive
compensation from the purchasers of the securities for whom they sell as principals. Each
particular agent will receive compensation in amounts negotiated in connection with the sale, which
might be in excess of customary commissions.
Underwriters
If we use underwriters for a sale of securities, the underwriters will acquire the securities
for their own account. The underwriters may resell the securities in one or more transactions,
including negotiated transactions, at a fixed public offering price or at varying prices determined
at the time of sale. The obligations of the underwriters to purchase the securities will be
subject to the conditions set forth in the applicable underwriting agreement. Unless the
prospectus supplement provides otherwise, underwriters will be obligated to purchase all of the
securities offered by the prospectus supplement. We may change from time to time any initial
public offering price and any discounts or concessions the underwriters allow or reallow or pay to
dealers. We may use underwriters with whom we have a material relationship, and we may offer the
securities to the public through an underwriting syndicate or through a single underwriter. We
will describe in the prospectus supplement naming the underwriter the nature of any such
relationship and underwriting arrangement.
Dealers
We also may sell securities to a dealer as principal. If we sell our securities to a dealer
as a principal, then the dealer may resell those securities to the public at varying prices to be
determined by such dealer at the time of resale. The name of the dealer and the terms of the
transactions will be set forth in the applicable prospectus supplement.
Direct Sales and Institutional Purchases
We may also sell securities directly to one or more purchasers, in which case underwriters or
agents would not be involved in the transaction.
Further, we may authorize agents, underwriters or dealers to solicit offers by certain types
of institutional investors to purchase securities from us at the public offering price set forth in
the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery
on a specified date in the future. We will describe the conditions to these contracts and the
commissions we must pay for solicitation of these contracts in an applicable prospectus supplement.
Stabilization Activities
Any underwriter may engage in overallotment, stabilizing transactions, short covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act of 1934, as
amended (the Exchange Act). Overallotment involves sales in excess of the offering size, which
create a short position. Stabilizing transactions permit bids to purchase the underlying security
so long as the stabilizing bids do not exceed a specified maximum. Short covering transactions
involve purchases in the open market after the distribution is completed to cover short positions.
Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the
securities originally sold by the dealer are purchased in a covering transaction to cover short
positions. Such activities may cause the price of the securities to be higher than they would
otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
These transactions may be effected on the NASDAQ Global Market or otherwise.
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Passive Market Making
Any underwriters who are qualified market makers on the NASDAQ Global Market may engage in
passive market making transactions on the NASDAQ Global Market in accordance with Rule 103 of
Regulation M, during the business day prior to the pricing of the offering, before the commencement
of offers or sales. Passive market makers must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market maker must display
its bid at a price not in excess of the highest independent bid for such security; if all
independent bids are lowered below the passive market makers bid, however, the passive market
makers bid must then be lowered when certain purchase limits are exceeded.
Costs
We will bear all costs, expenses and fees in connection with the registration of the
securities, as well as the expense of all commissions and discounts, if any, attributable to sales
of the securities by us.
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DESCRIPTION OF OUR CAPITAL STOCK
Set forth below is a summary of the material terms of our capital stock. This summary is not
complete. We encourage you to read our Amended and Restated Certificate of Incorporation (the
Certificate of Incorporation) and our Amended and Restated By-laws (the By-laws) that we have
previously filed with the SEC. See Where You Can Find More Information.
General
Our authorized capital stock consists of: (i) 100,000,000 shares of common stock, par value
$.01 per share, of which 61,684,361 shares were outstanding as of November 15, 2006, and (ii)
2,000,000 shares of preferred stock, par value $.01 per share, none of which are outstanding.
Common Stock
Holders of common stock are entitled to one vote for each share held on all matters submitted
to a vote of stockholders and do not have cumulative voting rights. Generally, all matters to be
voted on by stockholders must be approved by a majority, or, in the case of the election of
directors, by a plurality, of the votes cast at a meeting at which a quorum is present.
Holders of our common stock are entitled to receive ratably such dividends, if any, as may be
declared by the Board of Directors out of funds legally available therefor, subject to any
preferential dividend rights of any outstanding preferred stock. Upon the liquidation, dissolution
or winding up of the company, the holders of our common stock are entitled to receive ratably the
net assets of the company available after the payment of all debts and liabilities and subject to
the prior rights of any outstanding preferred stock.
Holders of our common stock are not entitled to pre-emptive rights or any rights of
conversion. Shares of our common stock are, and the shares being distributed in this offering will
be, when issued, fully paid and nonassessable. The rights, preferences and privileges of holders
of our common stock are subject, and may be adversely affected by, the rights of holders of shares
of any series of preferred stock which we may designate and issue in the future.
Our common stock is traded on the NASDAQ Global Market under the symbol NVAX. On November 20,
2006, the closing price of our common stock as reported on the NASDAQ Global Market was $5.28 per
share.
Our registrar and transfer agent for all shares of common stock is Computershare Limited, 250
Royall Street, Canton, MA 02021.
Preferred Stock
The Board of Directors may, without further action by the stockholders of the company, issue
preferred stock in one or more series and fix the rights and preferences thereof. Our Certificate
of Incorporation grants the Board of Directors authority to issue preferred stock and to determine
its rights and preferences without the need for further stockholder approval to eliminate delays
associated with a stockholder vote on specific issuances.
Examples of rights and preferences the Board of Directors may fix include dividend rights,
dividend rates, conversion rights, voting rights, pre-emptive rights, terms of redemption
(including sinking fund provisions), redemption prices and liquidation preferences. The issuance
of preferred stock, while providing desirable flexibility in connection with possible financings,
could have the effect of making it more difficult for a third party to acquire, or of discouraging
a third party from acquiring, a majority of the outstanding voting stock of the company. The
rights of holders of our common stock, described above, will be subject to, and may be adversely
affected by, the rights of any preferred stock that we may designate and issue in the future.
- 19 -
The terms of any particular series of preferred stock will be described in the prospectus
supplement relating to the offering of shares of that particular series of preferred and may
include, among other things:
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the title and stated value; |
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the number of shares authorized; |
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the liquidation preference per share; |
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the purchase price; |
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the dividend rate, period and payment date, and method of calculation (including
whether cumulative or non-cumulative); |
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terms and amount of any sinking fund; |
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provisions for redemption or repurchase, if applicable, and any restrictions on
the ability of the company to exercise such redemption and repurchase rights; |
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conversion rights and rates, if applicable, including the conversion price and
how and when it will be calculated and adjusted; |
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voting rights, if any; |
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preemptive rights, if any; |
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restrictions on sale, transfer and assignment, if any; |
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the relative ranking and preferences of the preferred stock; and |
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any other specific terms, rights or limitations of, or restrictions on, such preferred stock. |
Please also refer to the description of our Shareholder Rights Plan, below, for a discussion
of the companys Series D Junior Participating Preferred Stock.
Shareholder Rights Plan
We have adopted a Shareholder Rights Plan pursuant to which the Board of Directors declared a
dividend distribution of one preferred stock purchase right for each outstanding share of common
stock. Each right, once exercisable, entitles the holder to purchase from us one one-thousandth
(1/1,000th) of a share of Series D Junior Participating Preferred Stock (the Series D Preferred
Stock), at a price of $40.00, subject to certain adjustments.
The rights, unless earlier redeemed by the Board, become exercisable upon the close of
business on the day which is the earlier of (i) the tenth business day following a public
announcement that a person or group of affiliated or associated persons (with certain exceptions)
has acquired beneficial ownership of 15% or more of the outstanding voting stock of the company,
and (ii) the tenth business day after the date of the commencement by any person of a tender or
exchange offer, the consummation of which would result in such person or group of affiliated or
associated persons becoming an acquiring person as defined in the rights plan. The rights expire
at the close of business on August 7, 2012, unless earlier redeemed or exchanged by us as described
below.
Unless the rights are earlier redeemed, in the event that a person or group becomes an
acquiring person, the rights plan provides that proper provisions will be made so that each
holder of record of a right (other than rights beneficially owned by an acquiring person and
certain of its affiliates, associates and transferees) will thereafter have the right to receive,
upon payment of the exercise price, that number of shares of the Series D Preferred Stock having a
fair market value determined in accordance with the rights plan at the time of the transaction
equal to approximately two times the exercise price (such value to be determined with reference to
the fair market value of our common stock as provided in the plan).
- 20 -
In addition, unless the rights are earlier redeemed or exchanged, in the event that, after the
time that a person or group becomes an acquiring person, we were to be acquired in a merger or
other business combination (in which any shares of common stock are changed into or exchanged for
other securities or assets) or more than 50% of the assets or earning power of the company and its
subsidiaries (taken as a whole) were to be sold or transferred in one or a series of related
transactions, the rights plan provides that proper provision will be made so that each holder of
record of a right (other than rights beneficially owned by an acquiring person and certain of its
affiliates, associates and transferees) will have the right to receive, upon payment of the
exercise price, that number of shares of common stock of the acquiring company having a fair market
value at the time of such transaction determined in accordance with the rights plan equal to
approximately two times the exercise price.
At any time after any person or group becomes an acquiring person and prior to the acquisition
by such person or group of 50% or more of the outstanding voting stock, the Board may exchange the
rights, in whole or in part, for that number of shares of the Series D Preferred Stock having a
fair market value on the date such person or group became an acquiring person equal to the excess
of (i) the fair market value of Series D Preferred Stock issuable upon the exercise of the rights
over (ii) the exercise price of the rights, in each case subject to anti-dilution adjustments.
At any time prior to the close of business on the tenth business day after there has been a
public announcement that a person has become an acquiring person or such earlier date as a majority
of the Board shall become aware of the existence of an acquiring person, we may redeem the rights
in whole, but not in part, at a price of $.001 per right. Immediately upon the effective time of
such Board action, the right to exercise the rights will terminate and the only right of the
holders will be to receive the redemption price.
For as long as the rights are then redeemable, we may, except with respect to the redemption
price, amend the rights in any manner, including extending the time period in which the rights may
be redeemed. At any time when the rights are not then redeemable, we may amend the rights in any
manner that does not materially adversely affect the interests of holders of the rights as such.
Provisions of our Certificate of Incorporation and By-laws and Delaware Law
Certain provisions of our Certificate of Incorporation and By-laws may be deemed to have an
anti-takeover effect and may prevent, delay or defer a tender offer or takeover attempt that a
stockholder may deem in his, her or its best interest. The existence of these provisions also
could limit the price that investors might be willing to pay for our securities. They include:
Staggered Board, Removal of Directors and Charter Amendments relating to the Board
Our Certificate of Incorporation and By-laws provide for the division of our Board of
Directors into three classes, with no one class having more than one director more than any other
class, serving staggered three year terms. Our By-laws further provide that directors may be
removed only for cause by the affirmative vote of the holders of 2/3 of the shares of capital stock
of the company issued and outstanding and entitled to vote. Moreover, our Certificate of
Incorporation provides that any amendments to the charter relating to the number, classes,
election, term, removal, vacancies and related provisions with respect to the Board may only be
made by the affirmative vote of the holders of at least 75% of the shares of capital stock issued
and outstanding and entitled to vote. These provisions may have the effect of making it more
difficult for a third party to acquire control of Novavax, or of discouraging a third party from
acquiring control of the company.
Authorized but Unissued Shares
The authorized but unissued shares of our common stock and preferred stock are available for
future issuance without stockholder approval, subject to any limitations imposed by the NASDAQ
Stock Market. These additional shares may be utilized for a variety of corporate purposes. In
particular, although our Board of Directors has no present intention to do so, it could issue
shares of preferred stock that could, depending on the terms of the series, impede the completion
of a merger, tender offer, proxy contest or other takeover attempt. Our Board may determine that
the issuance of such shares of preferred stock is in the best interest of the company and our
stockholders. Such issuance could discourage a potential acquiror from making an unsolicited
acquisition attempt
through which such acquiror may be able to change the composition of the board, including a tender
offer or other transaction that some, or a majority, of our stockholders might believe to be in
their best interest or in which stockholders might receive a premium for their stock over the
then-current market price.
- 21 -
Advance Notice Requirements for Stockholder Proposals and Director Nominations
Our By-laws provide that a stockholder seeking to bring business before an annual meeting of
stockholders, or to nominate candidates for election as directors, must provide timely notice of
such stockholders intention in writing. To be timely, a stockholders notice must be received not
less than 60 nor more than 90 days prior to the meeting at which such candidate or proposal is to
be considered. However, if the company does not give prior notice or make public disclosure of the
date of the meeting at least 70 days prior to the meeting date, notice is considered timely if it
is received no later than the close of business on the 10th day following the date on
which such notice was given or public disclosure was made (whichever occurred first). If a
stockholder desires to have a proposal included in the companys proxy statement, notice of such
proposal must be received not less than 120 days prior to the first anniversary of the date of the
companys notice of the previous years annual meeting. These advance notice provisions may
preclude stockholders from bringing matters before a meeting or from making nominations for
directors.
Special Meetings of Stockholders
Our By-laws provide that special meetings of stockholders may be called by the Chief Executive
Officer (or, if there is no Chief Executive Officer, the President) or by the Board of Directors,
with no provision for any right of stockholders to call such meetings. Further, business
transacted at any special meeting of stockholders is limited to matters relating to the purpose or
purposes stated in the notice of meeting.
Section 203 of the General Corporation Law of the State of Delaware
We are subject to the provisions of Section 203 of the General Corporation Law of the State of
Delaware. Subject to certain exceptions, Section 203 prohibits a publicly-held Delaware corporation
from engaging in a business combination with an
interested stockholder for a period of three
years after the time such person became an interested stockholder, unless the interested
stockholder attained such status with the approval of our Board of Directors or unless the business
combination is approved in a prescribed manner. A business
combination is defined to include a
merger, asset sale or other transaction resulting in a financial benefit to the interested
stockholder. Subject to various exceptions, an interested stockholder is a person who, together
with affiliates and associates, owns, or within the past three years did own, 15% or more of a
corporations voting stock. This statutory provision could prohibit or delay the accomplishment of
mergers or other takeover or change in control attempts with respect to us and, accordingly, may
discourage attempts to acquire the company.
- 22 -
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.
- 23 -
The company currently does not have any outstanding warrants.
Exercise of Warrants
Each warrant will entitle its holder to purchase the number of shares of common or preferred
stock at the exercise price set forth in, or calculable as set forth in, the applicable prospectus
supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the
warrants may exercise the warrants at any time up to the expiration date set forth in the
applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void. We will specify the place or places where, and the manner in which,
warrants may be exercised in the applicable prospectus supplement. We will set forth on the
reverse side of the applicable certificate and in the applicable prospectus supplement the
information that the holder of the warrant will be required to deliver upon exercise.
Upon receipt of payment and the warrant certificate properly completed and duly executed, we
will, as soon as practicable, forward the purchased securities. If less than all of the warrants
represented by the warrant certificate are exercised, a new warrant certificate will be issued for
the remaining warrants.
Enforceability of Rights by Holders of Warrants
Each warrant agent will act solely as our agent under the applicable warrant agreement and
will not assume any obligation or relationship of agency or trust with any holder of any warrant. A
single bank or trust company may act as warrant agent for more than one issue of warrants. A
warrant agent will have no duty or responsibility in case of any default by us under the applicable
warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at
law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent
of the related warrant agent or the holder of any other warrant, enforce by appropriate legal
action its right to exercise, and receive the securities purchasable upon exercise of, such
holders warrants.
Prior to the exercise of any warrants to purchase preferred stock or common stock, holders of
the warrants will not have any of the rights of holders of the preferred stock or common stock
purchasable upon exercise, including the right to vote or to receive any payments of dividends.
- 24 -
DESCRIPTION OF OUR UNITS
We may issue units comprised of two or more of the other securities described in this
prospectus in any combination. Each unit will be issued so that the holder of the unit is also the
holder of each security included in the unit. Thus, the holder of a unit will have the rights and
obligations of a holder of each included security. The units may be issued under units agreements
to be entered into between us and a bank or trust company, as unit agent, as detailed in the
prospectus supplement relating to units being offered. The prospectus supplement will describe:
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the designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances the securities comprising the
units may be held or transferred separately; |
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a description of the terms of any unit agreement governing the units; |
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a description of the provisions for the payment, settlement, transfer or exchange of the units; |
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a discussion of material federal income tax considerations, if applicable; and |
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whether the units will be issued in fully registered or global form. |
The descriptions of the units in this prospectus and in any prospectus supplement are
summaries of the material provisions of the applicable agreements. These descriptions do not
restate those agreements in their entirety and may not contain all the information that you may
find useful. We urge you to read the applicable agreements because they, and not the summaries,
define your rights as holders of the units. For more information, please review the form of the
relevant agreements, which will be filed with the SEC promptly after the offering of units and will
be available as described under the heading Where You Can Find Additional Information.
- 25 -
DIVIDEND POLICY
We have never paid cash dividends on our common stock. We currently anticipate that we will
retain all of our earnings for use in the development of our business and do not anticipate paying
any cash dividends in the foreseeable future.
LEGAL MATTERS
Certain legal matters with respect to the securities offered hereby have been passed upon by
Ballard Spahr Andrews & Ingersoll, LLP.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2005, and managements assessment of the effectiveness of our internal control over financial
reporting as of December 31, 2005, as set forth in their reports, which are incorporated by
reference in this prospectus and elsewhere in the registration statement. Our financial statements
and managements assessment are incorporated by reference in reliance on Ernst & Young LLPs
report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Exchange Act, and in accordance with
the Exchange Act we file reports and other information with the SEC. These reports and other
information are not incorporated by reference in this prospectus and do not form a part of this
prospectus except as stated below under Incorporation of Certain Information by Reference. You
may read and copy these reports and other information filed with the SEC at the SECs Public
Reference Room located at 100 F Street, N.E., Washington, D.C. 20549. You can request copies of
these documents, for a copying fee, by writing to the SEC. Please call the SEC at 1-800-SEC-0330
or visit the SECs website for more information about the operation of the public reference room.
Our filings with the SEC are also available to you over the Internet at the SECs web site at
http://www.sec.gov. The companys web site is http://www.novavax.com.
Our common stock is traded on the NASDAQ Global Market under the symbol NVAX. Materials we
file can also be inspected at the offices of NASDAQ Operations at 1735 K Street, Washington, D.C.
20006.
We have filed a registration statement on Form S-3 (together with all amendments and exhibits,
which we refer to as the registration statement) with the SEC under the Securities Act with respect
to the securities offered by this prospectus. This prospectus, which constitutes a part of the
registration statement, does not contain all the information in the registration statement. For
further information about us and our securities, see the registration statement and its exhibits.
Statements made in this prospectus as to the content of any contract, agreement or other document
are not necessarily complete. With respect to each such contract, agreement or other document
filed as an exhibit to the registration statement, reference is made to the exhibit for a more
complete description of the matter involved, and each such statement shall be deemed qualified in
its entirety by such reference.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference in this prospectus the information in other
documents that we file with it, which means that we can disclose important information to you by
referring you to those documents containing such information. This prospectus is part of a
registration statement we filed with the SEC. You should rely on the information incorporated by
reference in this prospectus and the registration statement. The information incorporated by
reference is considered to be part of this prospectus and information we file later with the SEC
will automatically update and supersede this information and information contained in documents
filed earlier with the Commission. We incorporate by reference the documents listed below and any
future filings made with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior
to the termination of the offering; provided, that
we are not incorporating by reference any documents or information deemed to have been furnished
and not filed in accordance with SEC rules. The documents we are incorporating by reference are:
- 26 -
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Annual Report on Form 10-K for the fiscal year ended December 31, 2005; |
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Quarterly Reports on Form 10-Q for the quarters ended: |
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March 31, 2006; |
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June 30, 2006; and |
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September 30, 2006; |
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Current Reports on Form 8-K filed with the SEC on March 1, 2006 (Items 1.01 and 9.01);
March 21, 2006 (Items 1.01 and 9.01); April 21, 2006 (Items 4.01 and 9.01); May 19, 2006
(Item 5.02); May 26, 2006 (Items 5.02 and 9.01); July 12, 2006 (Item 3.01); August 17, 2006
(Items 1.01, 5.02 and 9.01); and September 7, 2006 (Items 5.02 and 9.01); |
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Definitive Proxy Statement with respect to the Annual Meeting of Stockholders held on
April 26, 2006, as filed with the SEC on March 23, 2006; and |
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The description of our common stock contained in the Registration Statement on Form 10
filed with the SEC on September 14, 1995. |
You may request a copy of any and all documents incorporated by reference herein (other than
exhibits to such documents unless such exhibits are specifically incorporated by reference into the
documents that this prospectus incorporates) at no cost by writing or telephoning our chief
financial officer at the following address and telephone number: Novavax, Inc., 508 Lapp Road,
Malvern, Pennsylvania 19355; (484) 913-1200. Attn: Jeffrey W. Church.
- 27 -
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The costs and expenses payable by the company in connection with the offerings described in
this registration statement are as follows:
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SEC registration fee |
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$ |
6,206 |
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Legal fees and expenses |
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25,000 |
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Accounting fees and expenses |
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30,000 |
* |
Transfer agent fees and expenses |
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5,000 |
* |
Miscellaneous expenses |
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5,000 |
* |
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Total |
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$ |
71,206 |
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Estimated as permitted under Rule 511 of Regulation S-K. |
Item 15. Indemnification of Directors and Officers.
General Corporation Law of Delaware
Section 145 of the General Corporation Law of Delaware provides that a corporation has the
power to indemnify a director, officer, employee or agent of the corporation and certain other
persons serving at the request of the corporation in related capacities against amounts paid and
expenses incurred in connection with an action or proceeding to which he or she is or is threatened
to be made a party by reason of such position, if such person shall have acted in good faith and in
a manner he or she reasonably believed to be in or not opposed to the best interests of the
corporation, and, in any criminal proceeding, if such person had no reasonable cause to believe his
or her conduct was unlawful, provided that, in the case of actions brought by or in the right of
the corporation, no indemnification shall be made with respect to any matter as to which such
person shall have been adjudged to be liable to the corporation unless and only to the extent that
the adjudicating court determines that such indemnification is proper under the circumstances.
Amended and Restated Certificate of Incorporation
Article NINTH of Novavaxs Amended and Restated Certificate of Incorporation provides that a
person (a) shall be indemnified against all expenses (including attorneys fees), judgments, fines
and amounts paid in settlement incurred in connection with any threatened, pending or completed
action, suit or other proceeding (other than an action by or in the right of the company) to which
he or she was or is a party or is threatened to be made a party by virtue of his or her position as
a director or officer of the company or, at the companys request, as a director, officer or
trustee of another corporation, partnership, joint venture, trust or other enterprise, if he or she
acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the
best interests of the company, and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his conduct was unlawful, and (b) shall be indemnified against all
expenses (including attorneys fees) and amounts paid in settlement incurred in connection with any
threatened, pending or completed action or suit by or in the right of the company to procure a
judgment in the companys favor to which he or she was or is a party or is threatened to be made a
party by virtue of his or her position as a director or officer of the company or, at the companys
request, as a director, officer or trustee of another corporation, partnership, joint venture,
trust or other enterprise, if he or she acted in good faith and in a manner he or she reasonably
believed to be in, or not opposed to, the best interests of the company, except that no
indemnification shall be made with respect to any matter under (b) as to which such person shall
have been adjudged to be liable to the company, unless and only to the extent that the Delaware
Chancery Court determines that, despite such adjudication but in view of all of the circumstances,
he or she is entitled to indemnification of such expenses. Notwithstanding the foregoing, to the
extent that a director or officer has been successful, on the merits or otherwise, including,
without limitation, the dismissal of an action without prejudice, he or she is required to be
indemnified against all expenses (including attorneys fees) incurred in connection therewith.
Expenses shall be advanced to a director or officer at his or her request; provided that he or she
undertakes to repay the amount advanced if it is ultimately determined that he or she is not
entitled to indemnification for such expenses.
II- 1
Indemnification is required to be made unless the company determines that the applicable
standard of conduct required for indemnification has not been met. In the event of a determination
by the company that the director or officer did not meet the applicable standard of conduct
required for indemnification, or if the company fails to make an indemnification payment within 60
days after such payment is claimed by such person, such person is permitted to petition the court
to make an independent determination as to whether such person is entitled to indemnification. As
a condition precedent to the right of indemnification, the director or officer must give the
company notice of the action for which indemnity is sought and the company has the right to
participate in such action or assume the defense thereof.
Article NINTH of Novavaxs Amended and Restated Certificate of Incorporation further provides
that the indemnification provided therein is not exclusive, and in the event that the General
Corporation Law of Delaware is amended to expand the indemnification permitted to directors or
officers, the company must indemnify those persons to the fullest extent permitted by such law as
so amended. The company is also permitted to maintain insurance to protect itself and any
director, officer, employee or agent against any expense, liability or loss incurred by him or her
in any such capacity, or arising out of his or her status as such, whether or not the company would
have the power to indemnify such person against such expense, liability or loss under the General
Corporation Law.
The company maintains insurance under which the insurers will reimburse the company for
amounts that it has paid to its directors and officers as indemnification for claims against such
persons in their official capacities. The insurance also covers such persons as to amounts paid by
them as a result of claims against them in their official capacities that are not reimbursed by the
company. The insurance is subject to certain limitations and exclusions.
Indemnity Agreements
The company has entered into indemnity agreements with each of its directors. Each agreement
provides that, with respect to third party proceedings, the company is obligated to indemnify a
director if such director was or is a party or is threatened to be made a party to any proceeding
(other than a proceeding by or in the right of the company) by reason of the fact that he or she is
or was a director and/or officer of the company, or is or was serving at the request of the company
as a director, officer, employee or agent of another corporation, partnership, joint venture,
trust, or other enterprise, against all expenses (as defined in the agreements), judgments, fines
and amounts paid in settlement actually and reasonably incurred by the director (or on his or her
behalf) in connection with such proceeding. In order to be eligible for indemnification, the
director must have acted in good faith and in a manner which he or she reasonably believed to be in
or not opposed to the best interests of the company and, in the case of a criminal proceeding, had
no reasonable cause to believe that his or her conduct was unlawful.
The company is also obligated to provide indemnification if the director was or is a party or
is threatened to be made a party to any proceeding by or in the right of the company to procure a
judgment in its favor by reason of the fact that the individual is or was a director and/or officer
of the company, or is or was serving at the request of the company as a director, officer, employee
or agent of another corporation, partnership, joint venture, trust, or other enterprise, against
all expenses actually and reasonably incurred by the director (or on his or her behalf) in
connection with the defense or settlement of such proceeding (or any claim, issue or matter
therein). Again, no such indemnification is permitted unless the indemnitee acted in good faith
and in a manner which he or she reasonably believed to be in or not opposed to the best interests
of the company and, in the case of a criminal proceeding, had no reasonable cause to believe that
his or her conduct was unlawful. In addition, no indemnification shall be made in respect of any
claim, issue or matter as to which a director shall have been adjudged to be liable to the company
unless and only to the extent that the Delaware Court of Chancery (or other court in which such
proceeding was brought or is pending) determines that, despite the adjudication of liability but in
view of all the circumstances of the case, the director is fairly and reasonably entitled to
indemnity for such expenses as the court deems proper.
To the extent that a director has been successful on the merits or otherwise (whether
partially or in full) in defense of any proceeding referred to above, or in defense of any claim,
issue or matter therein, he or she shall be indemnified against all expenses actually and
reasonably incurred in connection therewith. Moreover, indemnitees have the right to advancement
by the company prior to the final disposition of any proceeding or any claim, issue or other matter
therein of any and all expenses incurred in defense of such proceeding or any claim, issue or other
matter.
II- 2
A director must repay any amounts actually advanced to him or her that, at the final
disposition of the proceeding to which the advance related, exceeded the amounts paid or payable by
the director. The company must also have received an undertaking by or on behalf of the director
to repay such amounts to the extent that it is ultimately determined that the director is not
entitled to be indemnified.
A condition precedent to the right to be indemnified or receive advancement of expenses is the
delivery of written notice by the director to the company as soon as practicable of any proceeding
for which indemnity or advancement will or could be sought. A director will be entitled to
indemnification so long as he or she met the appropriate standard of conduct or was successful on
the merits or otherwise in defense of any such proceeding. Determination of a directors
entitlement to indemnification will be made, in the case of a change in control, by independent
counsel to the Board and, in all other cases, by a majority vote of disinterested directors (even
though less than a quorum), independent counsel, majority vote of a quorum of outstanding stock of
all classes entitled to vote, or a court of competent jurisdiction.
Item 16. Exhibits.
The exhibits marked with an asterisk are filed herewith. The remainder of the exhibits have
been previously filed with the SEC and are incorporated herein by reference.
1.1+ |
|
Form of Underwriting Agreement |
|
3.1 |
|
Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by
reference to Exhibit 3.1 to the Registrants Annual Report on Form 10-K for the fiscal
year ended December 31, 1996, File No. 000-26770, filed March 21, 1997), as amended by the
Certificate of Amendment dated December 18, 2000 (Incorporated by reference to Exhibit 3.4
to the Registrants Annual Report on Form 10-K for the fiscal year ended December 31,
2000, File No. 000-26770, filed March 29, 2001), as further amended by the Certificate of
Amendment dated July 8, 2004 (Incorporated by reference to Exhibit 3.1 to the Registrants
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2004, File No.
0-26770, filed August 9, 2004) |
|
3.2 |
|
Amended and Restated By-Laws of the Registrant. (Incorporated by reference to Exhibit
3.5 to the Registrants Quarterly Report on Form 10-Q for the fiscal quarter ended June
30, 2001, File No. 0-26770, filed August 13, 2001) |
|
4.1 |
|
Rights Agreement dated as of August 8, 2002, by and between Novavax, Inc. and EquiServe
Trust Company, N.A., as Rights Agent. The Rights Agreement includes as Exhibit A the form
of Summary of Rights to Purchase Series D Junior Participating Preferred Stock, as Exhibit
B the Form of Right Certificate and as Exhibit C the Form of Certificate of Designations
of Series D Junior Participating Preferred Stock. (Incorporated by reference to Exhibit
4.1 to the Registrants Current Report on Form 8-K, File No. 26770, filed August 9, 2002) |
|
4.2 |
|
Specimen stock certificate for shares of common stock, par value $.01 per share
(Incorporated by reference to Exhibit 4.1 to the Registrants Registration Statement on
Form 10, File No. 0-26770, filed September 14, 1995) |
|
4.3+ |
|
Form of Common Stock Warrant Agreement (together with form of warrant certificate) |
|
4.4+ |
|
Form of Preferred Stock Warrant Agreement (together with form of warrant certificate) |
|
4.5+ |
|
Form of Certificate of Designation for Preferred Stock (including specimen preferred
stock certificate) |
|
4.6+ |
|
Form of Unit Agreement (including form of unit certificate) |
|
5.1* |
|
Opinion of Ballard Spahr Andrews & Ingersoll, LLP |
|
23.1* |
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm |
II- 3
23.2* |
|
Consent of Ballard Spahr Andrews & Ingersoll, LLP (Included in Exhibit 5.1) |
|
24.1* |
|
Power of Attorney (Included in the signature pages hereto) |
|
|
|
* |
|
Filed herewith. |
|
+ |
|
To be filed as an exhibit to a report filed pursuant to Sections 13(a), 13(c) or 15(d) of the
Exchange Act or by post-effective amendment to the Registration Statement. |
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by section 10(a)(3) of the Securities Act of
1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information in the
registration statement. Notwithstanding the foregoing, any increase or decrease in volume
of securities offered (if the total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than
a 20% change in the maximum aggregate offering price set forth in the Calculation of
Registration Fee table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such
information in the registration statement;
Provided, however, that:
Paragraphs (1)(i), (1)(ii) and (1)(iii) of this section do not apply if the information
required to be included in a post-effective amendment by those paragraphs is contained in reports
filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of
the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(5) That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser:
(i) If the registrant is relying on Rule 430B:
(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be
deemed to be part of the registration statement as of the date the filed prospectus
was deemed part of and included in the registration statement; and
II- 4
(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or
(b)(7) as part of a registration statement in reliance on Rule 430B relating to an
offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of
providing the information required by section 10(a) of the Securities Act of 1933
shall be deemed to be part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after effectiveness or the
date of the first contract of sale of securities in the offering described in the
prospectus. As provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be deemed to be a new
effective date of the registration statement relating to the securities in the
registration statement to which that prospectus relates, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof, provided, however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a purchaser with a
time of contract of sale prior to such effective date, supersede or modify any
statement that was made in the registration statement or prospectus that was part of
the registration statement or made in any such document immediately prior to such
effective date; or
(ii) If the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule
424(b) as part of a registration statement relating to an offering, other than registration
statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A,
shall be deemed to be part of and included in the registration statement as of the date it
is first used after effectiveness, provided, however, that no statement made in a
registration statement or prospectus that is part of the registration statement or made in a
document incorporated or deemed incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a purchaser with a time of
contract of sale prior to such first use, supersede or modify any statement that was made in
the registration statement or prospectus that was part of the registration statement or made
in any such document immediately prior to such date of first use.
(6) That, for the purpose of determining liability of the registrant under the Securities Act
of 1933 to any purchaser in the initial distribution of the securities:
The undersigned registrant undertakes that in a primary offering of securities of the
undersigned registrant pursuant to this registration statement, regardless of the underwriting
method used to sell the securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned registrant will be a
seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to
the offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relating to the offering prepared by or on behalf of
the undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus relating to the offering
containing material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
(iv) Any other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(b) The undersigned registrant hereby further undertakes that, for purposes of determining any
liability under the Securities Act of 1933, each filing of the registrants annual report pursuant
to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable,
each filing of an employee benefit plans annual report pursuant to section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
II- 5
(h) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Securities Act of 1933, as amended, and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment by the registrant of
expenses incurred or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being registered, the registrant will, unless
in the opinion of its counsel the matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question of whether such indemnification by it is against
public policy as expressed in said act and will be governed by the final adjudication of such
issue.
(i) The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this registration statement in
reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act of 1933, each
post-effective amendment that contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
II- 6
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it
has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and
has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the Borough of Malvern, Commonwealth of Pennsylvania on the 22nd day
of November, 2006.
|
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NOVAVAX, INC.
|
|
|
By: |
/s/ Rahul Singhvi
|
|
|
|
Rahul Singhvi, President |
|
|
|
and Chief Executive Officer |
|
|
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes
and appoints Rahul Singhvi and Jeffrey W. Church and each or any one of them, his true and lawful
attorney-in-fact and agent with full power of substitution and resubstitution, for him and in his
name, place and stead, in any and all capacities, to sign any and all amendments (including
post-effective amendments and registration statements filed pursuant to Rule 462) to this
Registration Statement, and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto said
attorney-in-fact and agents, and each of them, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in connection wherewith, ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitutes
or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration
statement has been signed by the following persons in the capacities and on the dates indicated.
|
|
|
|
|
NAME |
|
TITLE |
|
DATE |
|
|
|
|
|
/s/ Rahul Singhvi
|
|
President, Chief Executive
|
|
November 22, 2006 |
|
|
Officer
and Director |
|
|
|
|
|
|
|
/s/ Jeffrey W. Church
|
|
Vice President, CFO, Treasurer
|
|
November 22, 2006 |
|
|
and
Secretary (Principal
Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/ Gary C. Evans
|
|
Chairman of the Board
|
|
November 22, 2006 |
|
|
|
|
|
|
|
|
|
|
/s/ John O. Marsh, Jr.
|
|
Director
|
|
November 22, 2006 |
|
|
|
|
|
|
|
|
|
|
/s/ Michael A. McManus, Jr.
|
|
Director
|
|
November 22, 2006 |
|
|
|
|
|
|
|
|
|
|
NAME |
|
TITLE |
|
DATE |
|
|
|
|
|
/s/ Thomas P. Monath, M.D.
|
|
Director
|
|
November 22, 2006 |
|
|
|
|
|
|
|
|
|
|
/s/ Denis M. ODonnell, M.D.
|
|
Director
|
|
November 22, 2006 |
|
|
|
|
|
|
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|
|
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/s/ James B. Tananbaum
|
|
Director
|
|
November 22, 2006 |
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|
EXHIBIT INDEX
The exhibits marked with an asterisk (*) are filed herewith; the exhibits marked with a plus
sign (+) shall be filed as an exhibit to a report filed pursuant to Sections 13(a), 13(c) or 15(d)
of the Exchange Act or by post-effective amendment to the Registration Statement.
1.1+ |
|
Form of Underwriting Agreement |
|
3.3 |
|
Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by
reference to Exhibit 3.1 to the Registrants Annual Report on Form 10-K for the fiscal
year ended December 31, 1996, File No. 000-26770, filed March 21, 1997), as amended by the
Certificate of Amendment dated December 18, 2000 (Incorporated by reference to Exhibit 3.4
to the Registrants Annual Report on Form 10-K for the fiscal year ended December 31,
2000, File No. 000-26770, filed March 29, 2001), as further amended by the Certificate of
Amendment dated July 8, 2004 (Incorporated by reference to Exhibit 3.1 to the Registrants
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2004, File No.
0-26770, filed August 9, 2004) |
|
3.4 |
|
Amended and Restated By-Laws of the Registrant. (Incorporated by reference to Exhibit
3.5 to the Registrants Quarterly Report on Form 10-Q for the fiscal quarter ended June
30, 2001, File No. 0-26770, filed August 13, 2001) |
|
4.1 |
|
Rights Agreement dated as of August 8, 2002, by and between Novavax, Inc. and EquiServe
Trust Company, N.A., as Rights Agent. The Rights Agreement includes as Exhibit A the form
of Summary of Rights to Purchase Series D Junior Participating Preferred Stock, as Exhibit
B the Form of Right Certificate and as Exhibit C the Form of Certificate of Designations
of Series D Junior Participating Preferred Stock. (Incorporated by reference to Exhibit
4.1 to the Registrants Current Report on Form 8-K, File No. 26770, filed August 9, 2002) |
|
4.2 |
|
Specimen stock certificate for shares of common stock, par value $.01 per share
(Incorporated by reference to Exhibit 4.1 to the Registrants Registration Statement on
Form 10, File No. 0-26770, filed September 14, 1995) |
|
4.3+ |
|
Form of Common Stock Warrant Agreement (together with form of warrant certificate) |
|
4.4+ |
|
Form of Preferred Stock Warrant Agreement (together with form of warrant certificate) |
|
4.5+ |
|
Form of Certificate of Designation for Preferred Stock (including specimen preferred
stock certificate) |
|
4.6+ |
|
Form of Unit Agreement (including form of unit certificate) |
|
5.1* |
|
Opinion of Ballard Spahr Andrews & Ingersoll, LLP |
|
23.1* |
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm |
|
23.2* |
|
Consent of Ballard Spahr Andrews & Ingersoll, LLP (Included in Exhibit 5.1) |
|
24.1* |
|
Power of Attorney (Included in the signature pages hereto) |