Filed Pursuant to Rule 424(b)(5)
Registration No. 333-108006
PROSPECTUS SUPPLEMENT
(TO PROSPECTUS DATED NOVEMBER 12, 2003)
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NOVAVAX, INC.
4,500,000 SHARES
COMMON STOCK
$6.15 PER SHARE
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We are offering 4,500,000 shares of our common stock, par value $.01 per
share, pursuant to this prospectus supplement.
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Our common stock is traded on the Nasdaq National Market under the symbol
NVAX. On November 12, 2003, the closing price of our common stock as reported on
the Nasdaq National Market was $6.18 per share.
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PER SHARE TOTAL
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Public offering price $6.150 $27,675,000
Underwriting discounts and commissions $0.369 $ 1,660,500
Proceeds, before expenses, to Novavax $5.781 $26,014,500
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The shares of our common stock will be ready for delivery on or about
November 18, 2003.
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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 supplement. Any representation to the contrary is a
criminal offense.
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INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK FACTORS"
BEGINNING ON PAGE S-7.
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C.E. UNTERBERG, TOWBIN
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THE DATE OF THIS PROSPECTUS SUPPLEMENT IS NOVEMBER 14, 2003.
TABLE OF CONTENTS
PROSPECTUS SUPPLEMENT
PAGE
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Summary................................................................................................... S-3
Risk Factors.............................................................................................. S-7
Special Note Regarding Forward-Looking Statements......................................................... S-15
Use of Proceeds........................................................................................... S-16
Capitalization............................................................................................ S-17
Common Stock Price Range and Dividend Policy.............................................................. S-18
Underwriting.............................................................................................. S-19
Legal Matters............................................................................................. S-21
Where You Can Find More Information....................................................................... S-21
PROSPECTUS
PAGE
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Prospectus Summary........................................................................................ 3
Risk Factors.............................................................................................. 6
About this Prospectus..................................................................................... 14
Special Note Regarding Forward-Looking Statements......................................................... 15
Use of Proceeds........................................................................................... 16
Plan of Distribution...................................................................................... 17
Description of Our Capital Stock.......................................................................... 20
Dividend Policy........................................................................................... 22
Legal Matters............................................................................................. 22
Experts................................................................................................... 22
Where You Can Find More Information....................................................................... 22
Incorporation of Certain Information by Reference......................................................... 23
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This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of this offering and also adds to
and updates information contained in the accompanying prospectus and the
documents incorporated by reference into the prospectus. The second part, the
accompanying prospectus, gives more general information, some of which does not
apply to this offering.
If the description of the offering varies between this prospectus
supplement and the accompanying prospectus, you should rely on the information
contained in, or incorporated by reference into, this prospectus supplement.
We have not authorized anyone to provide you with information different
from that contained in this prospectus supplement or the accompanying
prospectus. We are offering to sell our common stock, and seeking offers to buy,
only in jurisdictions where offers and sales are permitted. The information
contained in this prospectus supplement is accurate only as of the date hereof,
regardless of the time of delivery of this prospectus supplement or any sale of
our common stock.
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In this prospectus supplement, "we," "us" and "our" and "our company" refer
to Novavax, Inc., together with its subsidiaries, unless the context otherwise
requires.
S-2
SUMMARY
This summary highlights selected information contained elsewhere or
incorporated by reference in this prospectus supplement, and may not contain all
of the information that is important to you. For a more complete understanding
of this offering, you should read this entire document carefully and the
accompanying prospectus before deciding to invest in our common stock, including
the "Risk Factors" section below, and those additional documents to which we
refer you. See "Where You Can Find More Information" on page S-21.
OUR BUSINESS
Novavax is a fully-integrated specialty pharmaceutical company focused on
the research, development and commercialization of products utilizing our
proprietary drug delivery and vaccine technologies for large and growing
markets, concentrating on the areas of women's health and infectious diseases.
On October 9, 2003, the U.S. Food and Drug Administration approved
ESTRASORB(TM), our estradiol topical emulsion and the first topical emulsion for
estrogen replacement therapy, for for short-term use to reduce moderate to
severe vasomotor symptoms - commonly known as "hot flashes" - in menopausal
women. We will co-promote ESTRASORB with King in the United States and Puerto
Rico under the co-promotion agreement discussed below and expect to launch
ESTRASORB in early 2004 utilizing a combined sales force that is estimated to be
comprised of approximately 150 individuals at the time of launch. We believe
ESTRASORB will be competitively positioned to address the estrogen-only
replacement therapy market in the United States, which is estimated to be in
excess of $1.5 billion.
Our micellar nanoparticle technology involves the use of our patented oil
and water emulsions that we believe can be used as vehicles for the topical
delivery of a wide variety of drugs and other therapeutic products, including
hormones. We believe that our technology represents the first time that ethanol
soluble hormones, such as estrogen and testosterone, have been encapsulated and
delivered topically. In addition to ESTRASORB(TM), our product candidates using
these technologies include ANDROSORB(TM), a topical testosterone emulsion that
has completed two Phase I clinical trials; a topical estrogen and testosterone
emulsion; a topical progestin emulsion; and a topical estrogen and progestin
emulsion. We are utilizing other drug delivery technologies, such as our
Novasome(R) and Sterisome(R) technologies, in order to develop other products.
Novasomes are used as adjuvants to enhance vaccine effectiveness. Sterisomes are
being used for, among other things, subcutaneous injections that can deliver
long-acting drug effects. We also conduct research and development on
preventative vaccines and proteins for a variety of infectious diseases and
immunotherapies.
Over the past three years we have entered into a co-promotion agreement
with King Pharmaceuticals, Inc. for the promotion and marketing of ESTRASORB and
ANDROSORB (if approved) within the United States and Puerto Rico, and we have
licensed to King the right to sell these products outside the United States. Our
relationship with King has the potential to provide us with broader women's
health market coverage for ESTRASORB and ANDROSORB. Under the terms of our
co-promotion agreement with King, we will record all of the product sales,
returns and allowances, and cost of sales for ESTRASORB and ANDROSORB (if
approved) in the United States and Puerto Rico. The resultant gross margin will
be shared equally with King and the payment to King will be recorded as a
selling and marketing expense on our statement of operations. In addition, under
the agreement both parties will also share equally in approved marketing
expenses for the products. All direct marketing expenses will be recorded by us,
50% of which will be reimbursed by King. We received licensing fees of $3.0
million and milestone payments totaling $5.0 million from King upon the
submission to the FDA and acceptance for review of the ESTRASORB New Drug
Application. We have also received from King $20.0 million in December 2000,
$10.0 million in September 2001 and $10.0 million in June 2002, in the form of
convertible note financings.
We currently market, sell and distribute a line of prescription
pharmaceuticals through our 65 person sales force that has extensive experience
selling to obstetricians, gynecologists, managed care organizations, wholesalers
and retail pharmacies throughout the United States. In 2002, these products
generated revenues of $12.8 million. We expect to sell ESTRASORB through both
our sales force and King's sales force. We intend to manufacture ESTRASORB for
commercial sale in our dedicated, state-of-the-art, 24,000 square foot facility
in Philadelphia, Pennsylvania.
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RECENT DEVELOPMENTS
On August 8, 2003, we announced that Nelson M. Sims, a 28-year veteran of
Eli Lilly and Company, had been named President and Chief Executive Officer of
our company, succeeding Mitchell J. Kelly, who had served as President and Chief
Executive Officer since September 2002. Mr. Sims retired from Eli Lilly and
Company in 2001 following 28 years of service, during which he held numerous
executive management positions, including President of Eli Lilly Canada, Inc.,
Executive Director Strategic Alliance Management, Vice President Hybritech, Inc.
(a Lilly subsidiary) and U.S. Eastern Region Pharmaceutical Sales Director.
On September 29, 2003, we announced that we had been awarded a five year,
$19.0 million contract from the National Institute of Allergy and Infectious
Diseases for the design and development of a new class of human immunodeficiency
virus vaccine candidates for preclinical and clinical studies. We will serve as
prime contractor, with Emory University, Tulane University and the University of
Pittsburgh as sub-contractors, and we expect to receive approximately $14.0
million over the five-year contract term. This contract is the second award in
two months that we received for our HIV vaccine development program. In August
2003, we were part of a consortium that received a NIAID project program grant
to develop another set of HIV vaccine candidates. We expect to receive
approximately $4.0 million over 4 1/2 years for our participation in the grant
effort.
As noted above, ESTRASORB, our estradiol topical emulsion for estrogen
replacement therapy that utilizes a topical formulation developed by the
Company, was approved on October 9,, 2003 by the FDA for short-term use to
reduce moderate to severe vasomotor systems - commonly known as "hot flashes" -
in menopausal women.
In an effort to streamline and consolidate operations, we have decided to
close our St. Louis, Missouri packaging, warehouse and distribution facility for
our current women's health products, in December, 2003. We will transition the
operations conducted at this facility to our headquarters in Maryland and to
other third-party service providers. We do not expect to incur significant
additional costs, or experience any distribution delays, related to this
transition.
Our principal executive offices are located at 8320 Guilford Road,
Columbia, MD 21046. Our telephone number is (301) 854-3900. We are incorporated
under the laws of the State of Delaware.
S-4
THE OFFERING
Common stock offered..........................................4,500,000 shares
Common stock to be outstanding after
this offering.................................................34,679,550 shares
Use of proceeds...............................................For the commercial launch, marketing, selling,
manufacturing and other expenses related to
ESTRASORB; our internal research and development
programs, such as preclinical and clinical
testing and studies of our product candidates
and the development of new technologies; general
working capital; and possible future
acquisitions of complementary businesses,
product lines or technologies, although we are
not currently engaged in negotiations with
respect to any such acquisition.
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.
Nasdaq National Market Symbol.................................NVAX
The number of shares of our common stock to be outstanding after this
offering is based on the number of shares outstanding as of November 7, 2003,
and does not include:
- 4,844,833 shares issuable upon the exercise of stock options
outstanding as of such date;
- 1,646,834 shares available as of such date for future grant or
issuance pursuant to our stock option plans;
- 70,000 shares issuable upon the exercise of outstanding
warrants; and
- 5,075,241 shares issuable upon conversion of $40.0 million
aggregate principal amount of convertible notes, which is subject to
adjustment in connection with this offering.
S-5
SUMMARY CONSOLIDATED FINANCIAL DATA
The historical consolidated financial data presented below as of and for
each of the periods ended December 31, 2002, 2001 and 2000 were derived from our
audited consolidated financial statements. The summary consolidated financial
data is only a summary and should be read in conjunction with our consolidated
financial statements and related notes that we incorporate by reference in this
prospectus supplement. For copies of the financial information we incorporate by
reference, see "Where You Can Find More Information" on page S-21.
Information as of and for the nine months ended September 30, 2003 and 2002
has been derived from our consolidated financial statements, which are unaudited
but which in the opinion of management have been prepared on the same basis as
the audited consolidated financial statements and include all adjustments
necessary (consisting of normal recurring adjustments) for a fair presentation
of the results for such periods. The results of operations for the nine months
ended September 30, 2003 are not necessarily indicative of the results to be
expected for the entire year ending December 31, 2003 or any future period.
(AMOUNTS IN THOUSANDS, EXCEPT SHARE AND PER SHARE INFORMATION)
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Nine months ended Years ended
September 30, December 31,
2003 2002 2002 2001 2000
---- ---- ---- ---- ----
(unaudited) (unaudited)
(restated)
STATEMENT OF OPERATIONS DATA:
Revenues................................$ 7,737 $ 12,506 $ 15,005 $ 24,066 $ 2,475
Loss from operations.................... (12,994) (17,466) (21,558) (9,255) (12,742)
Net loss ............................... (14,190) (18,352) (22,697) (9,745) (12,191)
Per share information:
Basic and diluted net loss per share....$ (0.49) $ (0.75) $ (0.93) $ (0.43) $ (0.64)
Weighted average number of
shares outstanding.................... 29,045,982 24,359,013 24,433,868 22,670,274 19,015,719
As of September 30, As of December 31,
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2003 2002 2002 2001 2000
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(unaudited) (unaudited)
(restated)
BALANCE SHEET DATA:
Total current assets....................$ 10,247 $ 11,189 $ 6,242 $ 25,027 $ 17,036
Working capital......................... 4,998 4,433 378 18,030 12,331
Total assets ........................... 61,563 61,428 57,505 67,115 56,529
Convertible debt........................ 40,000 40,000 40,000 30,000 20,000
Stockholders equity..................... 12,831 12,235 8,073 7,493 31,824
S-6
RISK FACTORS
You should carefully read the following risk factors in addition to the
remainder of this prospectus supplement before purchasing any shares of our
common stock. Some of the following risks relate principally to our business and
the industry in which we operate. Other risks relate principally to the
securities market and ownership of our common stock. If any of the following
risks occur, our business, financial condition and/or operating results could be
adversely affected. In that case, the trading price of our common stock could
decline, and you could lose all or part of your investment.
OUR SUCCESS IS HEAVILY DEPENDENT ON MARKET ACCEPTANCE OF ESTRASORB.
ESTRASORB was approved by the FDA on October 9, 2003. Even with
ESTRASORB's approval by the FDA, there is no guarantee either that we and King
Pharmaceuticals, Inc., our marketing partner for ESTRASORB, will be able to
successfully commercialize ESTRASORB, or that ESTRASORB will be a commercial
success. Many factors could negatively affect our ability to successfully
commercialize ESTRASORB, including:
- delays in the manufacture and validation of ESTRASORB in
commercial quantities;
- our inability to timely and effectively promote and sell
ESTRASORB with King in the United States and Puerto Rico or by
King outside those regions, so that ESTRASORB gains a meaningful
share of the estrogen replacement therapy market, which
currently is dominated by Premarin(R), an oral estrogen tablet
sold by Wyeth, and estrogen patches sold by several companies
including Novartis Pharma AG, Berlex Laboratories, Inc. and
Forest Pharmaceuticals, Inc.;
- our inability to manufacture ESTRASORB at acceptable gross
margins; and
- our inability to obtain coverage and favorable reimbursement
rates for ESTRASORB from insurers and other third party payors.
WE WILL FACE SUBSTANTIAL COMPETITION IN CONNECTION WITH THE SALE OF
ESTRASORB AND OUR OTHER PRODUCT CANDIDATES.
We compete with numerous other companies worldwide that have developed or
are developing products that compete or may compete with ESTRASORB and our
product candidates. These competitors include both large and small
pharmaceutical companies, biotechnology firms, universities and other research
institutions. We may not succeed in developing technologies and products that
are more effective than those being developed by our competitors.
Many large companies currently produce and sell estrogen products for
clinical indications identical to those for ESTRASORB. In the oral product
segment of the estrogen replacement therapy market, which accounts for
approximately 74% of the market according to 2002 IMS Health Incorporated data,
Wyeth commits significant resources to the sale and marketing of its product,
Premarin(R), in order to maintain its market leadership position.
Warner-Chillcot also competes in the branded oral product segment with its
product, Estrace(R). In addition, ESTRASORB will compete with products produced
and sold by generic manufacturers in the oral product segment of the market,
such as Watson Pharmaceutical, Inc.'s generic product, Estropipate(R). In the
patch segment of the market, which according to IMS Health accounts for
approximately 15% of the estrogen replacement therapy market, several companies
market transdermal estrogen patches with which ESTRASORB will compete. For
example, Novartis Pharma AG currently markets and sells its Vivelle(R) and
Estraderm(R) patches and Berlex Laboratories, Inc. and Forest Pharmaceuticals
Inc. co-promote the Climara(R) transdermal patch. Several companies also
currently market ethanol-based estrogen gels and ointments outside the United
States. For example, Schering Canada sells its estrogen gel, Estrogel(R), in
Canada. These and other products sold by our competitors have all achieved some
degree of market penetration. ESTRASORB will compete in the United States for
market share with these products and we cannot guarantee that, together with
King, we will be able to effectively promote ESTRASORB against these competitive
products. In order to effectively compete, we will make substantial investments
in sales and marketing. Many of these products are sold by companies with
greater resources than we
S-7
have and there is no assurance that we will be successful in gaining significant
market share for ESTRASORB or in earning a return on our investment in ESTRASORB
or our other product candidates, if approved.
Our technologies and products may be rendered obsolete or noncompetitive as
a result of products introduced by competitors. Most of our competitors have
substantially greater financial and technical resources, production and
marketing capabilities, and related experience than we do. The greater
resources, capabilities and experience of our competitors may enable them to
develop, manufacture and market their products more successfully and at a lower
cost than we can. In addition, many of our competitors have significantly
greater experience than we do in conducting preclinical testing and clinical
trials of human pharmaceuticals and obtaining regulatory approvals to market
such products. Accordingly, our competitors may succeed in obtaining FDA
approval for products more rapidly than we will, which may give them an
advantage over us in achieving market acceptance of their products.
WE ARE UNCERTAIN ABOUT OUR ABILITY TO OBTAIN FUTURE FINANCING.
We cannot be certain that we will be able to generate revenues from product
sales in the near term or at all sufficient to fund our operations, and we could
require additional funds to continue our research and development programs,
commence future preclinical and clinical trials, seek regulatory approvals,
establish commercial-scale manufacturing capabilities, and market our products.
We may seek additional funds through public or private equity or debt
financings, collaborative arrangements with pharmaceutical companies, and other
sources. We cannot be certain that adequate additional funding will be available
to us on acceptable terms, if at all. If we cannot raise the additional funds we
may need 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 selling, marketing, 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.
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, 2003 was $101.7 million. Our revenues
for the last three years were $15.0 million in 2002, $24.0 million in 2001 and
$2.5 million in 2000. For the nine months ended September 30, 2003 and 2002, our
revenues were $7.7 million and $12.5 million, respectively. Sales of products
that we acquired as a result of our acquisition of Fielding Pharmaceutical
Company in 2000 have generated modest revenues, but based on our current
business plan these revenues will not be sufficient to offset our expenses in
the future. We cannot be certain when or if we will generate substantial
revenues from the sale of ESTRASORB. We have received a very limited amount of
product-related revenue from research contracts, licenses and agreements to
provide vaccine products, services and adjuvant technologies. We cannot be
certain that we will be successful in entering into strategic alliances or
collaborative arrangements with other companies that will result in other
significant revenues to offset our expenses. Our net losses for the last three
years were $22.7 million in 2002, $9.7 million in 2001 and $12.2 million in
2000, while they were $14.2 million and $18.4 million for the nine months ended
September 30, 2003 and 2002, respectively. Our losses have resulted from
research and development expenses, pre-launch sales and marketing expenses in
the anticipation of FDA approval for ESTRASORB, protection of our intellectual
property, and other general operating expenses. Our annual losses may increase
depending on the timing of the launch of ESTRASORB as we expand our
manufacturing capacity, sales and marketing capabilities and conduct additional
and larger clinical trials for other product candidates. Therefore, we expect
our cumulative operating loss to increase until such time, if ever, product
sales, licensing fees and royalty payments generate sufficient revenue to fund
our continuing operations. We cannot predict when, if ever, we might achieve
profitability and cannot be certain that we will be able to sustain
profitability, if achieved.
We intend to allocate a significant portion of our sales force's time to
the product launch of ESTRASORB. Accordingly, the sales of our other women's
health products could be adversely affected by the efforts we allocate to the
ESTRASORB product launch. The costs of maintaining our own sales force to market
our current products and ESTRASORB may in the future exceed product revenues. If
we continue to market ESTRASORB or future products directly, significant
additional expenditures and management resources may be required to increase the
size of our internal sales force.
S-8
OUR SALES AND MARKETING PLAN FOR ESTRASORB DEPENDS IN LARGE PART ON THE
SUCCESS OF OUR RELATIONSHIP WITH KING.
We have entered into a co-promotion agreement with King for the marketing
and promotion of ESTRASORB in the United States using our sales and marketing
personnel and King's sales and marketing personnel. We have also granted King
exclusive rights to promote, market and distribute ESTRASORB outside the United
States. In return, we received certain milestone payments. We are entitled to
receive additional payments upon the achievement of specified milestones and
licensing fees and royalties on future sales. While our co-promotion and
licensing agreements with King give us some limited protections with respect to
King's marketing and sales efforts and, we believe, create financial incentives
for King consistent with our own, we cannot control the amount and timing of the
marketing efforts that King devotes to ESTRASORB, or make any assurances that
co-promotion efforts by the Company and King of ESTRASORB in the United States,
and King's marketing of ESTRASORB outside the United States, will be successful.
Our success in marketing other potential future products will also depend
in large part on our relationship with King. Our co-promotion agreement with
King also provides for the co-promotion with King in the United States of our
product candidate ANDROSORB(TM). If this product is approved for marketing by
the FDA, King has an exclusive worldwide license, except in the United States,
to market this product. Under our co-promotion agreement, King also has the
right to co-promote certain future hormone replacement therapy products that we
may develop in the field of women's health. In the future, we might enter into
other licensing or co-promotion arrangements with King or other third parties
for the marketing and sale of other future products. Assuming FDA approval, any
revenues we receive from sales of ANDROSORB and other future products will
depend in large part on the terms of these agreements and the efforts of King
and any other third-party marketing partners.
OUR AGREEMENTS WITH KING REDUCE THE LIKELIHOOD THAT WE COULD BE ACQUIRED BY
ANOTHER COMPANY.
Our co-promotion agreement and license agreement with King for the
marketing of ESTRASORB and ANDROSORB contain several provisions that would take
effect upon a change of control of the Company. One provision allows King
several options in the event of a change in control of Novavax including (i)
terminating our right to co-promote King products, (ii) terminating our rights
to promote ESTRASORB and ANDROSORB (if approved) and certain other hormone
therapies for women, or (iii) requiring Novavax to assign and transfer to King
all related rights of ownership for ESTRASORB and ANDROSORB and certain other
hormone replacement therapies for women and license to King on an exclusive and
perpetual basis all intellectual property rights and know-how with respect to
such products. If King chooses to exercise its rights under either clause (ii)
or (iii) above, King will pay us royalties on net sales of such products. In
addition, King will pay us for the cost of manufacturing, plus a markup
consistent with the terms of the license agreement for handling costs. In the
event of a change in control, King could also require that we redeem $40.0
million in aggregate principal amount of our outstanding convertible promissory
notes that it currently holds, at a redemption price equal to 101% of the
outstanding principal and accrued interest. These provisions may have the effect
of making us less attractive as an acquisition candidate.
WE NEED ADDITIONAL MANUFACTURING CAPABILITY TO COMMERCIALIZE OUR PRODUCTS.
We do not have any experience with the large capacity manufacturing
required for commercial sale of a product. Although we have had the ability to
produce the limited quantities of products needed to support our current
research and development programs and clinical trials (including utilizing
contract manufacturing organizations), we will need more production capacity for
larger, later-stage clinical studies and commercial sales. Our potential
products may be too difficult or costly to manufacture on a large scale, to
develop into commercially viable products, or to market.
We have validated our manufacturing methods for ESTRASORB, which has been
produced in 100-kilo size batches. Such validation is required under FDA
guidelines, and we received FDA approval of these methods in connection with the
approval of ESTRASORB. We currently manufacture ESTRASORB at a facility of
Cardinal Health, Inc. in Philadelphia, Pennsylvania. We expect that Cardinal
Health will provide packaging services for ESTRASORB that we manufacture in
their facility. We have completed the build out of the facility to meet our
requirements and have installed manufacturing equipment for commercial
production of ESTRASORB. Now that
S-9
this new equipment is installed, we need to validate that the ESTRASORB made
using this new equipment is identical to that used in our clinical trials. If we
are unable to make ESTRASORB on a commercial scale or are delayed in validating
the product manufactured with our new equipment, the commercialization of
ESTRASORB would be delayed.
In the near term, we will be manufacturing ESTRASORB only in the
Philadelphia facility. Now that ESTRASORB has been approved by the FDA, we may
determine to qualify an additional site or sites for the manufacture of
ESTRASORB as our production requirements increase. If we are unable to utilize
the Philadelphia facility to manufacture ESTRASORB prior to our qualification of
a second site, however, we would not have immediate access to ESTRASORB and
would be required to reestablish our validation process at a different facility
that would cause us to lose sales of ESTRASORB and would adversely affect our
business.
We currently utilize third-party contract manufacturers to manufacture our
other products. Any contract manufacturer's facility that we may use, including
the Cardinal Health facility, must adhere to the FDA's regulations on current
good manufacturing practices, which are enforced by the FDA through its
facilities inspection program. These facilities are subject to periodic
inspection by the FDA. The manufacture of products at these facilities will be
subject to strict quality control testing and record-keeping requirements. We
may not be able to enter into alternative manufacturing arrangements at
commercially acceptable rates, if at all. Moreover, the manufacturers we use may
not provide sufficient quantities of product to meet our specifications or our
delivery, cost and other requirements.
If we decide to manufacture our own products, we will need to acquire
additional manufacturing facilities and improve our manufacturing technology.
Establishing additional manufacturing facilities will require us to spend
substantial funds, hire and retain a significant number of additional personnel
and comply with extensive regulations applicable to such facilities in the
United States and abroad, including the current good laboratory practices and
good manufacturing practices required by the FDA. If we elect or need to
manufacture our own products, we risk the possibility that we may not be able to
do so in a timely fashion at acceptable quality and prices or in compliance with
good laboratory practices and good manufacturing practices.
WE HAVE NOT COMPLETED THE DEVELOPMENT OF MANY OF OUR PRODUCTS AND WE MAY
NOT SUCCEED IN OBTAINING THE FDA APPROVAL NECESSARY TO SELL ANY ADDITIONAL
PRODUCTS.
The development, manufacture and marketing of our pharmaceutical products
are subject to government regulation in the United States and other countries.
In the United States and most foreign countries, we must complete rigorous
preclinical testing and extensive human clinical trials that demonstrate the
safety and efficacy of a product in order to apply for regulatory approval to
market the product. Only a few of our products have been approved for sale,
including ESTRASORB. Our product candidate, ANDROSORB, has completed two Phase I
human clinical studies. Our other product candidates are in preclinical
laboratory or animal studies. Before applying for FDA approval to market any
additional product candidates, we must conduct larger-scale Phase II and III
human clinical trials that demonstrate the safety and efficacy of our products,
including ANDROSORB, to the satisfaction of the FDA or other regulatory
authorities. 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 the FDA or other regulatory authorities. We may also be
required to demonstrate that our proposed products represent an improved form of
treatment over existing therapies and we may be unable to do so without
conducting further clinical studies.
We may fail to obtain regulatory approval for our products on a timely
basis. Delays in obtaining regulatory approval can be extremely costly in terms
of lost sales opportunities and increased clinical trial costs. The speed with
which we complete our clinical trials and our applications for marketing
approval will depend on several factors, including the following:
- the rate of patient enrollment, which is a function of many
factors, including the size of the patient population, the
proximity of patients to clinical sites, the eligibility
criteria for the study and the nature of the protocol;
S-10
- institutional review board approval of the protocol and the
informed consent form;
- prior regulatory agency review and approval;
- analysis of data obtained from preclinical and clinical
activities that are susceptible to varying interpretations,
which interpretations could delay, limit or prevent regulatory
approval;
- changes in the policies of regulatory authorities for drug
approval during the period of product development; and
- the availability of skilled and experienced staff to conduct and
monitor clinical studies and to prepare the appropriate
regulatory applications.
We have limited experience in conducting and managing the preclinical and
clinical trials necessary to obtain regulatory marketing approvals. We may not
be able to obtain the approvals necessary to conduct clinical studies. Also, the
results of our clinical trials may not be consistent with the results obtained
in preclinical studies or the results obtained in later phases of clinical
trials may not be consistent with those obtained in earlier phases. A number of
companies in the specialty pharmaceutical industry have suffered significant
setbacks in advanced clinical trials, even after experiencing promising results
in early animal and human testing. If regulatory approval of a drug is granted,
such approval is likely to limit the indicated uses for which it may be
marketed. Furthermore, even if a product of ours gains regulatory approval, the
product and the manufacturer of the product will be subject to continuing
regulatory review. We may be restricted or prohibited from marketing or
manufacturing a product, even after obtaining product approval, if previously
unknown problems with the product or its manufacture are subsequently
discovered.
OUR SUCCESS DEPENDS ON OUR ABILITY TO MAINTAIN THE PROPRIETARY NATURE OF
OUR TECHNOLOGY.
Our success will, in large part, depend on our ability to maintain the
proprietary nature of our technology and other trade secrets. To do so, we must
prosecute and maintain existing patents, obtain new patents and pursue trade
secret protection. We also must operate without infringing the proprietary
rights of third parties or letting third parties infringe our rights. We
currently have 55 U.S. patents and approximately 150 foreign patents and patent
applications covering our technologies. We recently filed eight new patent
applications in the United States and worldwide directed towards innovative
discoveries made in the field of human Papillomavirus virus-like particles.
However, patent issues relating to pharmaceuticals involve complex legal,
scientific and factual questions. To date, no consistent policy has emerged
regarding the breadth of biotechnology patent claims that are granted by the 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
may claim that we are infringing their patents or proprietary rights. We could
incur substantial costs in defending patent infringement suits or in filing
suits against others to have their patents declared invalid or claim
infringement. It is also possible that we may be required to obtain licenses
from third parties to avoid infringing third-party patents or other proprietary
rights. We cannot be sure that such third-party licenses would be available to
us on acceptable terms, if at all. If we are unable to obtain required
third-party licenses, we may be delayed in or prohibited from developing,
manufacturing or selling products requiring such licenses.
Although our patents include claims covering various features of our
product candidates, including composition, methods of manufacture and use, our
patents do not provide us with complete protection against the development of
competing products. For example, our patents do not prohibit third parties from
developing and selling products for estrogen replacement therapy that deliver
estrogen through a topical emulsion, ointment or similar medium.
S-11
Some of our know-how and technology is not patentable. To protect our
proprietary rights in unpatentable intellectual property and trade secrets, we
require employees, consultants, advisors and collaborators to enter into
confidentiality agreements. These agreements may not provide meaningful
protection for our trade secrets, know-how or other proprietary information in
the event of any unauthorized use or disclosure.
HEALTH CARE INSURERS AND OTHER PAYORS MAY NOT PAY FOR OUR PRODUCTS OR
MAY IMPOSE LIMITS ON REIMBURSEMENT.
Our ability to commercialize ESTRASORB and our future products will
depend, in part, on the extent to which reimbursement for such products will be
available from third-party payors, such as Medicare, Medicaid, health
maintenance organizations, health insurers and other public and private payors.
If we succeed in bringing ESTRASORB or other products in the future to market,
we cannot be assured that third-party payors will pay for ESTRASORB or such
products or will establish and maintain price levels sufficient for realization
of an appropriate return on our investment in product development. For example,
ESTRASORB will be sold as an outpatient prescription drug. Medicare does not
cover the costs of most outpatient prescription drugs. We expect that ESTRASORB
will be treated the same as other estrogen replacement therapy products with
respect to government and third-party payor reimbursement. However, there can be
no assurance that ESTRASORB will receive similar reimbursement treatment.
Many health maintenance organizations and other third-party payors use
formularies, or lists of drugs for which coverage is provided under a health
care benefit plan, to control the costs of prescription drugs. Each payor that
maintains a drug formulary makes its own determination as to whether a new drug
will be added to the formulary and whether particular drugs in a therapeutic
class will have preferred status over other drugs in the same class. This
determination often involves an assessment of the clinical appropriateness of
the drug and sometimes 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 $18.0
million for claims arising from the use of our currently marketed products and
products in clinical trials prior to FDA approval. Coverage is becoming
increasingly expensive, however, and we may not be able to maintain insurance at
a reasonable cost. 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 may be time-consuming and
expensive, may damage our reputation in the marketplace, and may divert
management's attention.
WE HAVE MADE LOANS TO CERTAIN OF OUR DIRECTORS, AND HAVE GUARANTEED A
BROKERAGE MARGIN LOAN FOR ONE OF THESE DIRECTORS THAT COULD HAVE A NEGATIVE
IMPACT ON OUR STOCK PRICE.
In 2002, pursuant to our Stock Option Plan, we approved the payment of
the exercise price of options by two 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. In addition, in 2002 we executed a conditional guaranty of a brokerage
margin account for a director in the amount of $500,000. Due to heightened
sensitivity in the current environment surrounding related party transactions,
these transactions could be viewed negatively in the market and our stock price
could be negatively affected.
S-12
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 2002, our common stock traded in a range from a low of
$1.59 to a high of $14.00. Between January 1, 2003 and November 12, 2003, our
common stock has traded in a range from a low of $2.52 to a high of $ 8.62. It
is likely that the price of our common stock will fluctuate in the future. The
market prices of securities of small-capitalization, specialty pharmaceutical
companies, including ours, from time to time experience significant price and
volume fluctuations unrelated to the operating performance of these companies.
In particular, the market price of our common stock may fluctuate significantly
due to a variety of factors, including:
- governmental agency actions, including the FDA's determination
with respect to NDAs for new products;
- our ability to obtain financing; and
- sales of our products, particularly ESTRASORB.
In addition, the occurrence of any of the risks described in this "Risk Factors"
section could have a material and adverse impact on the market price of our
common stock.
OUR SUBSTANTIAL INDEBTEDNESS COULD ADVERSELY AFFECT OUR CASH FLOW AND
PREVENT US FROM FULFILLING OUR OBLIGATIONS.
We currently have $41.5 million of outstanding indebtedness. Our
substantial amount of outstanding indebtedness could have significant
consequences. For example, it:
- could increase our vulnerability to general adverse economic and
industry conditions;
- will require 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;
- could limit our flexibility in planning for, or reacting to,
changes in our business and the pharmaceutical industry, which
may place us at a competitive disadvantage compared with
competitors that have less indebtedness; and
- could limit our ability to borrow additional funds, even when
necessary to maintain adequate liquidity.
We may incur additional indebtedness for various reasons, which, if in
excess of a certain amount, must be approved by King. Any such additional
indebtedness would increase the risks associated with our substantial leverage.
OUR INABILITY TO RECRUIT AND RETAIN MEMBERS OF OUR MANAGEMENT TEAM AND KEY
PERSONNEL COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS.
Our future success will depend in part on our ability to attract and retain
highly-skilled employees, particularly those in management, sales, regulatory,
manufacturing and technical positions. The loss of services of members of our
management team could adversely affect our business and impede or delay
achievement of our corporate mission. Furthermore, recruiting and retaining
qualified scientific and other key employees will be critical to our success,
and competition for such employees in our targeted industry and in our
geographic regions is intense. In addition, many of the companies with which we
compete for highly qualified personnel have greater financial and other
resources than we do. We may be unable to attract and retain key employees on
acceptable terms given the level and nature of such competition.
S-13
ANTI-TAKEOVER PROVISIONS COULD MAKE A THIRD-PARTY ACQUISITION OF US MORE
DIFFICULT.
In 2002, we adopted a Shareholder Rights Plan that provided for the
issuance of rights to purchase shares of Series D Junior Participating Preferred
Stock of our company. Under the plan, we distributed one preferred share
purchase right for each outstanding share of our common stock. Each purchase
right entitles the holder to purchase from our company one one-thousandth
(1/1000th) of a share of Series D Junior Participating Preferred Stock at a
price of $40, subject to adjustment. The rights become exercisable, with certain
exceptions, 10 business days after any party, without prior approval of our
Board of Directors, acquires or announces an offer to acquire beneficial
ownership of 15% or more of our common stock. In the event that any party
acquires 15% or more of our common stock, we enter into a merger or other
business combination, or if a substantial portion of our assets is sold after
the time that the rights become exercisable, the holder of a right will receive,
upon exercise of the right, shares of the common stock of the surviving or
acquiring company, as applicable, having a market value of twice the exercise
price of the right. The Shareholder Rights Plan may discourage or prevent
certain types of transactions involving an actual or potential change in control
of our company, which transactions may be beneficial to our shareholders, by
causing substantial dilution to a party that attempts to acquire us on terms not
approved by our Board.
THIS OFFERING AND FUTURE ISSUANCES OF SHARES OF OUR COMMON STOCK OR OTHER
SECURITIES WILL DILUTE SHAREHOLDERS' INTERESTS IN OUR COMPANY AND MAY ADVERSELY
AFFECT THE TRADING PRICE OF OUR COMMON STOCK.
The number of shares of our common stock issued and sold in this offering
is substantial, and will result in dilution of existing stockholders' percentage
ownership interest in our company. In addition, there can be no assurance that
the funds raised by this offering or revenues from product sales will be
adequate to enable us to fund our operations. We may seek additional capital
through future offerings of shares of our common stock or other securities,
which would cause dilution of existing stockholders' percentage interest in our
company. These future offerings could also have a material and adverse
effect on the trading price of our common stock.
S-14
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus supplement, the accompanying prospectus
and the documents incorporated by reference contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
These statements are based on management's beliefs and assumptions and on
information currently available to management, and use words such as "expect,"
"anticipate," "intend," "plan," "believe," "estimate," "may," "could,"
"possible," "forecast," or similar words and expressions. Forward-looking
statements include but are not limited to statements regarding product sales,
future results of operations, future product development and related clinical
trials, and future research and development, including FDA approval of our
product candidates. Forward-looking statements are only predictions, and
necessarily involve risks and uncertainties and other factors that may cause the
actual results, performance or achievements of Novavax, or industry results, to
be materially different from those anticipated in or implied by the
forward-looking statements. These risks, uncertainties and other factors are
discussed in the "Risk Factors" section and elsewhere in this prospectus
supplement, the accompanying prospectus and the documents incorporated by
reference and include, among other things, the following: general economic and
business conditions; competition; unexpected changes in technologies and
technological advances; ability to obtain rights to technology; ability to
obtain and enforce patents; ability to commercialize and manufacture products;
ability to establish and maintain commercial-scale manufacturing capabilities;
ability to enter into future collaborations with industry partners; results of
clinical studies; progress of research and development activities; business
abilities and judgment of personnel; availability of qualified personnel;
changes in, or failure to comply with, governmental regulations; ability to
obtain adequate financing in the future; and other factors referenced in this
prospectus supplement, the accompanying prospectus and the documents
incorporated by reference.
S-15
USE OF PROCEEDS
Our net proceeds, after deducting underwriting discounts and commissions
and other offering expenses, from the sale of 4.5 million shares of common stock
in this offering will be approximately $25.8 million.
We will retain broad discretion over the use of the net proceeds from the
sale of our common stock. We currently intend to use the net proceeds from this
offering for general corporate purposes, including but not limited to:
- the commercial launch, marketing, selling, manufacturing and
other expenses related to ESTRASORB;
- our internal research and development programs, such as
preclinical and clinical testing and studies of our product
candidates and the development of new technologies;
- general working capital; and
- possible future acquisitions of complementary businesses,
product lines or technologies, although we are not currently
engaged in negotiations with respect to any such acquisitions.
We have not determined the amounts we plan to spend on any of the areas
listed above or the timing of these expenditures, which may vary significantly
depending on various factors such as our research and development results,
regulatory approvals, competition, marketing and sales, and the market
acceptance of any products introduced by us. As a result, our management will
have broad discretion to allocate the net proceeds from this offering. Pending
application of the net proceeds as described above, we intend to invest these
net proceeds in short-term, interest-bearing, investment-grade securities.
S-16
CAPITALIZATION
The following table sets forth our capitalization as of September 30, 2003
on an actual basis and on an as-adjusted basis to give effect to the sale of
common stock in this offering and our application of the net proceeds from this
offering, as if this offering had occurred on September 30, 2003.
You should read this table along with our consolidated financial statements
and the related notes that are incorporated into this prospectus supplement by
reference.
SEPTEMBER 30, 2003
ACTUAL AS ADJUSTED
------ -----------
(UNAUDITED)
Convertible notes 40,000 40,000
Other long term debt (including current portion) 1,522 1,522
------ --------
41,522 41,522
Stockholders' equity:
Preferred stock, $.01 par value, 2,000,000 shares authorized;
no shares issued or outstanding - -
Common stock, $.01 par value, 50,000,000 shares authorized;
30,392,360 shares issued and 30,142,300 outstanding
on an actual basis, 34,892,360 shares issued and
34,642,300 outstanding on an adjusted basis 304 349
Additional paid-in capital 120,457 146,241
Notes receivable from shareholders (1,480) (1,480)
Accumulated deficit (101,717) (101,717)
Treasury stock, 250,060 and 557,752 shares, cost basis (4,733) (4,733)
---------- ------------
Total stockholders' equity 12,831 38,660
---------- ------------
Total capitalization 54,353 80,182
---------- ------------
Information in the table above excludes the following shares of common
stock as of November 7, 2003:
- 4,844,833 shares issuable upon the exercise of stock options
outstanding as of such date;
- 1,646,834 shares available as of such date for future grant or
issuance pursuant to our stock option plans;
- 70,000 shares issuable upon the exercise of outstanding
warrants; and
- 5,075,241 shares issuable upon conversion of $40.0 million
aggregate principal amount of convertible promissory notes,
which is subject to adjustment in connection with this offering.
S-17
COMMON STOCK PRICE RANGE AND DIVIDEND POLICY
Our common stock is traded on the Nasdaq National Market under the symbol
"NVAX." Prior to July 2001, our common stock was traded on the American Stock
Exchange under the symbol "NOX."
The following table sets forth the reported high and low sales prices for
our common stock, for the periods presented, on the applicable exchange.
PRICE RANGE
-----------
HIGH LOW
---- ---
2001
----
First Quarter $11.00 $ 7.10
Second Quarter $11.00 $ 6.35
Third Quarter $14.50 $ 9.06
Fourth Quarter $15.55 $10.51
2002
----
First Quarter $14.00 $ 8.77
Second Quarter $11.98 $ 3.57
Third Quarter $ 4.81 $ 1.59
Fourth Quarter $ 4.37 $ 2.13
2003
----
First Quarter $ 4.75 $ 2.52
Second Quarter $ 6.87 $ 3.26
Third Quarter $ 7.94 $ 4.76
Fourth Quarter (through November 12) $ 8.62 $ 5.80
The closing price for our common stock on the Nasdaq National Market on
November 12, 2003 was $6.18 per share.
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.
S-18
UNDERWRITING
We are offering the shares described in this prospectus supplement through
C.E. Unterberg, Towbin, which we refer to as the "underwriter," with which we
have entered an underwriting agreement. Subject to the terms and conditions of
the underwriting agreement, we have agreed to sell to the underwriter, and the
underwriter has agreed to purchase from us, 4,500,000 shares of our common
stock.
Subject to the conditions set forth in the underwriting agreement, the
underwriter is obligated to purchase all of the shares of common stock offered
by this prospectus supplement. The underwriter will initially offer the shares
of our common stock to the public at the price specified on the cover page of
this prospectus supplement. These sales may include sales to affiliates of the
underwriter, including investment funds managed by the underwriter.
If all the shares of our common stock offered by this prospectus supplement
are not sold at the public offering price, the underwriter may change the public
offering price and other selling terms. The shares are offered subject to a
number of conditions, including:
- receipt and acceptance of the shares by the underwriter; and
- the underwriter's right to reject orders in whole and in part.
Our common stock is listed on the Nasdaq National Market under the symbol
"NVAX."
In compliance with guidelines of the National Association of Securities
Dealers, Inc., the maximum compensation to the underwriter or dealers in
connection with the sale of our common stock pursuant to this prospectus
supplement and the accompanying prospectus will not exceed 8% of the aggregate
total offering price of the common stock as set forth on the cover page of this
prospectus supplement. The maximum compensation paid to the underwriter in
connection with this offering will be less than 8%.
The underwriting agreement provides that we will indemnify the underwriter
against civil liabilities specified in the agreement, including under the
Securities Act of 1933, as amended (the "Securities Act") and for breaches of
our representations and warranties contained in the underwriting agreement. If
we are unable to provide indemnification, we will be required to contribute to
payments that the underwriter may be required to make relating to those
liabilities.
COMMISSIONS AND DISCOUNTS
The following table shows, on a per share and total basis, the public
offering price, underwriting discounts and commissions to be paid to the
underwriter and proceeds before expenses to us.
PER SHARE TOTAL
--------- -----
Public offering price $6.150 $27,675,000
Underwriting discounts and commissions $0.369 $ 1,660,500
Proceeds, before expenses, to Novavax $5.781 $26,014,500
We estimate that the expenses of this offering, not including the
underwriting discounts and commissions, will be approximately $185,000. These
expenses are payable by us.
NO SALES OF SIMILAR SECURITIES
We have agreed that, for a period of 30 days after the date of the
underwriting agreement, we will not, without the underwriter's prior written
consent, offer, sell, contract to sell, pledge, grant any option, right or
warrant to purchase, or otherwise transfer or dispose of, directly or
indirectly, any shares of our common stock or any securities
S-19
convertible into or exercisable or exchangeable for shares of our common stock
or publicly announce an intention to effect any such transaction, except for the
shares offered in this offering, shares issuable pursuant to an employee stock
option plan, and shares issuable upon the exercise of outstanding options and
warrants or the conversion of convertible securities that are outstanding on the
date of the underwriting agreement.
STABILIZATION ACTIVITIES
In connection with and in order to facilitate this offering, the
underwriter may engage in activities that stabilize, maintain or otherwise
affect the price of the shares of our common stock, including:
- stabilizing transactions;
- short sales; and
- purchases to cover positions created by short sales.
Stabilizing transactions consist of bids or purchases made for the purpose
of preventing or retarding a decline in the market price of the shares of our
common stock while this offering is in progress. Stabilizing transactions may
include making short sales of the shares of our common stock, which involves the
sale by the underwriter of a greater number of shares of our common stock than
it is required to purchase in this offering. The underwriter may close out a
short position by purchasing shares of our common stock in the open market.
Similar to other purchase transactions, the underwriter's purchases to
cover short sales may have the effect of raising or maintaining the market price
of our common stock or preventing or retarding a decline in the market price of
our common stock. As a result, the price of the shares of our common stock may
be higher than the price that otherwise might exist in the open market. If the
underwriter commences these activities, it may discontinue them at any time. The
underwriter may carry out these transactions on the Nasdaq Stock Market, in the
over-the-counter market or otherwise.
Neither we nor the underwriter make any representation or prediction as to
the direction or magnitude of any effect that the transactions described above
may have on the price of our common stock. In addition, neither we nor the
underwriter make any representation that the underwriter will engage in these
transactions or that these transactions, once commenced, will not be
discontinued without notice.
S-20
LEGAL MATTERS
Certain legal matters with respect to the shares of common stock offered
hereby have been passed upon by White White & Van Etten LLP, 55 Cambridge
Parkway, Cambridge, Massachusetts 02142. David A. White, a partner of such firm,
owns 50,000 shares of our common stock.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Securities Exchange
Act of 1934, as amended (the "Exchange Act"), and in accordance with the
Exchange Act we file reports and other information with the SEC. You may read
and copy these reports and other information filed with the SEC at the SEC's
Public Reference Room located at 450 Fifth Street, N.W., Washington, D.C.. You
can request copies of these documents, for a copying fee, by writing to the SEC.
Please call the SEC at 1-800-SEC-0330 or visit the SEC's website for more
information about the operation of the public reference rooms. Our filings with
the SEC are also available to you over the Internet at the SEC's web site at
http://www.sec.gov.
Our common stock is traded as "National Market Securities" on the Nasdaq
National Market under the symbol NVAX. Materials we file can also be inspected
at the offices of Nasdaq Operations at 1735 K Street, Washington, D.C. 20006.
We have filed a registration statement on Form S-3 (together with all
amendments and exhibits, which we refer to as the "registration statement") with
the SEC under the Securities Act with respect to the shares of our common stock
offered by this prospectus supplement. Neither this prospectus supplement nor
the accompanying prospectus, which constitute a part of the registration
statement, contain all of the information in the registration statement. For
further information about our company and our securities, see the registration
statement and the exhibits to the registration statement. Statements made in
this prospectus supplement and the accompanying 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.
S-21
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY
NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER
TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
PROSPECTUS
Subject to Completion, Dated November 12, 2003
---------------------
$50,000,000
NOVAVAX, INC.
COMMON STOCK
---------------------
We may sell from time to time shares of our common stock, par value $.01
per share, in one or more offerings with a maximum aggregate offering price of
$50,000,000. This means:
- we will provide a prospectus supplement each time we issue common stock;
and
- the prospectus supplement will inform you about the specific terms of
that offering and may also add, update or modify information contained
in this document.
---------------------
Our common stock is traded on the Nasdaq National Market under the
symbol NVAX. On August 8, 2003, the closing price of our common stock as
reported on the Nasdaq National Market was $5.66 per share.
---------------------
Our principal offices are located at 8320 Guilford Road, Columbia,
Maryland 21046. Our telephone number is (301) 854-3900.
---------------------
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" BEGINNING ON PAGE 6.
---------------------
Neither the Securities and Exchange Commission nor any other regulatory body has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus. Any representation to the contrary is a criminal
offense.
THE DATE OF THIS PROSPECTUS IS _________, 2003.
TABLE OF CONTENTS
PAGE
----
Prospectus Summary........................................................................................ 3
Risk Factors.............................................................................................. 6
About this Prospectus..................................................................................... 14
Special Note Regarding Forward-Looking Statements......................................................... 15
Use of Proceeds........................................................................................... 16
Plan of Distribution...................................................................................... 17
Description of Our Capital Stock.......................................................................... 20
Dividend Policy........................................................................................... 22
Legal Matters............................................................................................. 22
Experts................................................................................................... 22
Where You Can Find More Information....................................................................... 22
Incorporation of Certain Information by Reference......................................................... 23
---------------------
You should rely only on the information contained in this prospectus and
in any prospectus supplement. We have not authorized anyone to provide you with
information different from that contained in this prospectus or any prospectus
supplement. We are offering to sell our common stock, and seeking offers to buy,
only in jurisdictions where offers and sales are permitted. The information
contained in this prospectus is accurate only as of the date of this prospectus,
regardless of the time of delivery of this prospectus or any sale of our common
stock.
---------------------
In this prospectus, the "Company," "we," "us" and "our" refer to
Novavax, Inc., together with its subsidiaries, unless the context otherwise
requires.
-2-
PROSPECTUS SUMMARY
This summary highlights selected information contained elsewhere or
incorporated by reference in this prospectus, and may not contain all of the
information that is important to you. For a more complete understanding of this
offering, you should read this entire document carefully before deciding to
invest in our common stock, including the "Risk Factors" section below, and
those additional documents to which we refer you. See "Where You Can Find More
Information" on page 22.
OUR BUSINESS
Novavax is a fully-integrated specialty pharmaceutical company focused
on the research, development and commercialization of products utilizing our
proprietary drug delivery and vaccine technologies for large and growing
markets, concentrating on the areas of women's health and infectious diseases.
Our lead product candidate, ESTRASORB(TM), is the first topical emulsion for
estrogen replacement therapy for which a New Drug Application has been accepted
for review by the Food and Drug Administration. The NDA for ESTRASORB was
submitted in June 2001 and was accepted for review in August 2001. In April
2002, we were informed by the FDA that the agency had completed its review of
the NDA for ESTRASORB. At that time, the agency did not raise any issues
regarding the efficacy or safety of ESTRASORB, but did request additional
information with respect to the Chemistry, Manufacturing and Controls section of
the filing. We determined that the most advantageous approach to resolving the
outstanding CMC questions was to voluntarily withdraw the NDA and resubmit it
once all of the responses to the CMC questions had been prepared. In September
2002, we re-submitted the NDA, which was accepted for review by the FDA in
November 2002. In June 2003, the agency informed us that it would need
additional time for a full review of our Estradiol Partner Transfer Study Report
submitted in May of this year. Under the Prescription Drug User Fee Act the
statutory minimum extension time is 90 days, which thus results in a new goal
date for a decision on the approvability of ESTRASORB of no later than October
10, 2003. We are seeking FDA approval of ESTRASORB for the reduction of hot
flushes in menopausal women and, if approved, we believe ESTRASORB will be
competitively positioned to address the estimated $1.8 billion estrogen
replacement therapy market in the United States.
Our micellar nanoparticle technology involves the use of our patented
oil and water emulsions that we believe can be used as vehicles for the topical
delivery of a wide variety of drugs and other therapeutic products, including
hormones. We believe that our technology represents the first time that ethanol
soluble hormones, such as estrogen and testosterone, have been encapsulated and
delivered topically. In addition to ESTRASORB, our product candidates using
these technologies include ANDROSORB(TM), a topical testosterone emulsion that
has completed two Phase I clinical trials; TESTESTRASORB(TM), a topical estrogen
and testosterone emulsion; PROGESTSORB(TM) NE, a topical progestin emulsion; and
PROESTRASORB(TM), a topical estrogen and progestin emulsion. Other drug delivery
technologies, such as our Novasome(R) and Sterisome(R) technologies, are being
utilized to develop other products. Novasomes are used as adjuvants to enhance
vaccine effectiveness. Sterisomes are being used for, among other things,
subcutaneous injections that can deliver long-acting drug effects. We also
conduct research and development on preventative vaccines and proteins for a
variety of infectious diseases and immunotherapies.
Over the past three years we have entered into a co-promotion agreement
with King Pharmaceuticals, Inc. for the promotion and marketing of ESTRASORB and
ANDROSORB within the United States and Puerto Rico, and we have licensed to King
the right to sell these products outside the United States. Our relationship
with King has the potential to provide us with broader women's health market
coverage for ESTRASORB and ANDROSORB. Under the terms of our co-promotion
agreement with King, we will record all of the product sales, returns and
allowances, and cost of sales for ESTRASORB and ANDROSORB in the United States
and Puerto Rico. The resultant gross margin will be shared equally with King and
the payment to King will be recorded as a selling and marketing expense on our
statement of operations. In addition, following product approval by the FDA,
both parties will share equally in approved marketing expenses for the products.
All direct marketing expenses will be recorded by us, for which King will
reimburse us fifty percent. We received licensing fees of $3.0 million and
milestone payments totaling $5.0 million from King upon the submission to the
FDA and acceptance for review of the ESTRASORB NDA. We have also received from
King $20.0 million in December 2000, $10.0 million in September 2001 and $10.0
million in June 2002, in the form of convertible note financings.
-3-
We currently market, sell and distribute a line of prescription
pharmaceuticals through our 64 person sales force that has extensive experience
selling to obstetricians, gynecologists, managed care organizations, wholesalers
and retail pharmacies throughout the United States. In 2002, these products
generated revenues of $12.8 million. If we receive marketing approval from the
FDA, we expect to sell ESTRASORB through both our sales force and King's sales
force. We intend to manufacture ESTRASORB for commercial sale in our dedicated,
state-of-the-art, 24,000 square foot facility in Philadelphia, Pennsylvania,
which was substantially completed in December 2002.
Our principal executive offices are located at 8320 Guilford Road,
Columbia, MD 21046. Our telephone number is (301) 854-3900. We are incorporated
under the laws of the State of Delaware.
-4-
SUMMARY CONSOLIDATED FINANCIAL DATA
The historical consolidated financial data presented below as of and for
each of the periods ended December 31, 2002, 2001 and 2000 were derived from our
audited consolidated financial statements. The summary consolidated financial
data is only a summary and should be read in conjunction with our consolidated
financial statements and related notes that we incorporate by reference in this
prospectus. For copies of the financial information we incorporate by reference,
see "Where You Can Find More Information" on page 22.
Information as of June 30, 2003 and for the six months ended June 30,
2003 and 2002 has been derived from our consolidated financial statements, which
are unaudited but which in the opinion of management have been prepared on the
same basis as the audited consolidated financial statements and include all
adjustments necessary (consisting of normal recurring adjustments) for a fair
presentation of the results for such periods. The results of operations for the
quarter ended June 30, 2003 are not necessarily indicative of the results to be
expected for the entire year ending December 31, 2003 or any future period.
(AMOUNTS IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE INFORMATION)
-----------------------------------------------------------------------
for the six months ended for the years ended
June 30, December 31,
---------------------- -----------------------------------------------------------------
2003 2002 2002 2001 2000 1999 1998
---- ---- ---- ---- ---- ---- ----
(unaudited) (unaudited) (restated)
STATEMENT OF OPERATIONS DATA:
Revenues.......................$ 3,469 $10,177 $15,005 $24,066 $ 2,475 $ 1,181 $ 681
Loss from operations (10,033) (10,990) (21,558) (9,255) (12,742) (4,566) (5,152)
Net loss ....................... (10,830) (11,500) (22,697) (9,745) (12,191) (4,506) (4,817)
Per share information:
Net loss per share.............$ (0.38) $ (0.48) $ (0.93) $ (0.43) $ (0.64) $ (0.31) $(0.39)
Weighted average number of
shares outstanding........... 28,489,651 24,209,198 24,433,868 22,670,274 19,015,719 14,511,081 12,428,426
As of June 30, As of December 31,
---------------------- ----------------------------------------------------------
2003 2002 2002 2001 2000 1999 1998
---- ---- ---- ---- ---- ---- ----
(unaudited) (unaudited) (restated)
BALANCE SHEET DATA:
Total current assets...........$ 12,837 $21,100 $ 6,242 $25,027 $ 17,036 $ 1,143 $1,207
Working capital 8,646 13,326 378 18,030 12,331 (480) 349
Total assets ....................63,908 69,387 57,505 67,115 56,529 4,463 3,819
Convertible debt.................40,000 40,000 40,000 30,000 20,000 -- --
Stockholders' equity.............16,122 19,113 8,073 27,493 31,824 2,840 2,961
-5-
RISK FACTORS
You should carefully read the following risk factors in addition to the
remainder of this prospectus before purchasing any shares of our common stock.
Some of the following risks relate principally to our business and the industry
in which we operate. Other risks relate principally to the securities market and
ownership of our common stock. If any of the following risks occur, our
business, financial condition and/or operating results could be adversely
affected. In that case, the trading price of our common stock could decline, and
you could lose all or part of your investment.
OUR SUCCESS IS HEAVILY DEPENDENT ON FDA APPROVAL AND MARKET ACCEPTANCE
OF ESTRASORB.
Our New Drug Application for ESTRASORB was accepted for review by the
FDA in November 2002. There is no guarantee that the FDA will approve our
application and allow us to begin selling ESTRASORB in the United States. If we
do not receive FDA approval of our application, our inability to sell ESTRASORB
in the United States would have a significant negative effect on our business
and results of operations. Even if ESTRASORB is approved by the FDA, there is no
guarantee that we and King Pharmaceuticals, Inc., our marketing partner for
ESTRASORB, will be able to successfully commercialize ESTRASORB. Many factors
could negatively affect our ability to successfully commercialize ESTRASORB,
including:
- a failure or delay in ESTRASORB gaining a meaningful share of the
estrogen replacement therapy market, which currently is dominated by
Premarin(R), an oral estrogen tablet sold by Wyeth, and estrogen patches
sold by several companies including Novartis Pharma AG, Berlex
Laboratories, Inc. and Forest Pharmaceuticals, Inc.;
- our inability to effectively promote and sell ESTRASORB with King in the
United States, or King's inability to do so in the rest of the world;
- delays in the manufacture of ESTRASORB in commercial quantities; and
- the inability to obtain coverage and favorable reimbursement rates for
ESTRASORB from insurers and other third party payors.
WE WILL FACE SUBSTANTIAL COMPETITION IN CONNECTION WITH THE SALE OF
ESTRASORB AND OUR OTHER PRODUCT CANDIDATES.
We compete with numerous other companies worldwide that have developed
or are developing products that compete or may compete with our product
candidates. These competitors include both large and small pharmaceutical
companies, biotechnology firms, universities and other research institutions. We
may not succeed in developing technologies and products that are more effective
than those being developed by our competitors.
Many large companies currently produce and sell estrogen products for
clinical indications identical to those that we seek for ESTRASORB. In the oral
product segment of the estrogen replacement therapy market, which accounts for
approximately 74% of the market according to 2002 IMS Health Incorporated data,
Wyeth commits significant resources to the sale and marketing of its product,
Premarin(R), in order to maintain its market leadership position.
Warner-Chillcot also competes in the branded oral product segment with its
product, Estrace(R). In addition, ESTRASORB will compete with products produced
and sold by generic manufacturers in the oral product segment of the market,
such as Watson Pharmaceutical, Inc.'s generic product, Estropipate(R). In the
patch segment of the market, which according to IMS Health accounts for
approximately 15% of the estrogen replacement therapy market, several companies
market transdermal estrogen patches with which ESTRASORB will compete, if
approved. For example, Novartis Pharma AG currently markets and sells its
Vivelle(R) and Estraderm(R) patches and Berlex Laboratories, Inc. and Forest
Pharmaceuticals Inc. co-promote the Climara(R) transdermal patch. Several
companies also currently market ethanol-based estrogen gels and ointments
outside the United States. For example, Schering Canada sells its estrogen gel,
Estrogel(R), in Canada. These and other products sold by our competitors have
all been approved for sale and have achieved some degree of market penetration.
If ESTRASORB is approved for sale in the Untied States, it will compete for
market share with these products and we cannot guarantee that, together with
King, we will be able to effectively promote ESTRASORB against these competitive
products. In order to
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effectively compete, we may make substantial investments in sales and marketing.
Many of these products are sold by companies with greater resources than we have
and there is no assurance that we will be successful in gaining significant
market share for ESTRASORB or in earning a return on that investment.
Our technologies and products may be rendered obsolete or noncompetitive
as a result of products introduced by competitors. Most of our competitors have
substantially greater financial and technical resources, production and
marketing capabilities, and related experience than we do. The greater
resources, capabilities and experience of our competitors may enable them to
develop, manufacture and market their products more successfully and at a lower
cost than we can. In addition, many of our competitors have significantly
greater experience than we do in conducting preclinical testing and clinical
trials of human pharmaceuticals and obtaining regulatory approvals to market
such products. Accordingly, our competitors may succeed in obtaining FDA
approval for products more rapidly than we will, which may give them an
advantage over us in achieving market acceptance of their products.
WE WOULD NEED ADDITIONAL CAPITAL TO GROW AND OPERATE OUR BUSINESS IN THE
EVENT WE WERE UNABLE TO RAISE CAPITAL IN THIS OFFERING, AND WE ARE UNCERTAIN
ABOUT OBTAINING FUTURE FINANCING.
We estimate that our existing cash resources will be sufficient to
finance our operations at current and projected levels of development and
general corporate activity for the next 5 to 7 months. We cannot be certain that
we will be able to generate revenues from product sales in the near term or at
all sufficient to fund our operations. If w were unable to raise capital in this
offering, we would require additional funds to continue our research and
development, commence future preclinical and clinical trials, seek regulatory
approvals, establish commercial-scale manufacturing capabilities, and market our
products. We may seek additional funds through public or private equity or debt
financings, collaborative arrangements with pharmaceutical companies and other
sources. We cannot be certain that adequate additional funding will be available
to us on acceptable terms, if at all. If we cannot raise the additional funds we
may need to continue our current and anticipated operations, we may be required
to delay significantly, reduce the scope of, or eliminate one or more of, our
research or development programs. If that is the case, we will seek other
alternatives to avoid insolvency, including arrangements with collaborative
partners or others that may require us to relinquish rights to certain of our
technologies, product candidates or products.
WE HAVE A HISTORY OF LOSSES AND OUR FUTURE PROFITABILITY IS UNCERTAIN.
Our expenses have exceeded our revenues since our formation in 1987, and
our accumulated deficit at June 30, 2003 was $98.4 million. Our revenues for the
last three years were $15.0 million in 2002, $24.0 million in 2001 and $2.5
million in 2000. For the six months ended June 30, 2003 and 2002, our revenues
were $3.5 million and $10.2 million, respectively. Sales of products that we
acquired as a result of our acquisition of Fielding Pharmaceutical Company in
2000 have generated modest revenues, but based on our current business plan
these revenues will not be sufficient to offset our expenses in the future. We
cannot be certain when or if we will generate substantial revenues from the sale
of ESTRASORB. We have received a very limited amount of product-related revenue
from research contracts, licenses and agreements to provide vaccine products,
services and adjuvant technologies. We cannot be certain that we will be
successful in entering into strategic alliances or collaborative arrangements
with other companies that will result in other significant revenues to offset
our expenses. Our net losses for the last three years were $22.7 million in
2002, $9.7 million in 2001 and $12.1 million in 2000, while they were $10.8
million and $11.5 million for the six months ended June 30, 2003 and 2002,
respectively. Our losses have resulted from research and development expenses,
pre-launch sales and marketing expenses in the anticipation of FDA approval for
ESTRASORB, protection of our intellectual property, and other general operating
expenses. Our annual losses may increase depending on the timing of the FDA
approval and launch of ESTRASORB as we expand our manufacturing capacity, sales
and marketing capabilities and conduct additional and larger clinical trials for
other product candidates. Therefore, we expect our cumulative operating loss to
increase until such time, if ever, as product sales, licensing fees and royalty
payments generate sufficient revenue to fund our continuing operations. We
cannot predict when, if ever, we might achieve profitability and cannot be
certain that we will be able to sustain profitability, if achieved.
We intend to allocate a significant portion of our sales force's time to
the product launch of ESTRASORB, if and when it is approved by the FDA.
Accordingly, the sales of our other women's health products could be adversely
affected by the efforts we allocate to the ESTRASORB product launch. The costs
of maintaining our own
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sales force to market our current products and ESTRASORB, if approved, may in
the future exceed product revenues. If we continue to market ESTRASORB or future
products directly, significant additional expenditures and management resources
may be required to increase the size of our internal sales force.
OUR SALES AND MARKETING PLAN FOR ESTRASORB DEPENDS IN LARGE PART ON THE
SUCCESS OF OUR RELATIONSHIP WITH KING.
We have entered into a co-promotion agreement with King for the
marketing and promotion of ESTRASORB in the United States using our sales and
marketing personnel and King's sales and marketing personnel. We have also
granted King exclusive rights to promote, market and distribute ESTRASORB
outside the United States. In return, we received certain milestone payments and
the agreement to pay potential future milestone payments and licensing fees and
royalties on future sales. While our agreements with King give us some limited
protections with respect to King's marketing and sales efforts and, we believe,
create financial incentives for King consistent with our own, we cannot control
the amount and timing of marketing efforts that King devotes to ESTRASORB or
make any assurances that our and King's co-promotion of ESTRASORB in the United
States and King's marketing of ESTRASORB in the rest of the world will be
successful.
Our success in marketing other potential future products will also
depend in large part on our relationship with King. Our co-promotion agreement
with King also provides for co-promotion in the United States with King of our
product candidate ANDROSORB(TM). If this product is approved for marketing by
the FDA, King has an exclusive worldwide license, except in the United States,
to market this future product. Under our co-promotion agreement, King has the
right to co-promote certain future hormone replacement therapy products in the
field of women's health. In the future, we might enter into other licensing or
co-promotion arrangements with King or other third parties for the marketing and
sale of other future products. Any revenues we receive from sales of ANDROSORB
and other future products will depend in large part on the terms of these
agreements and the efforts of King and any other third-party marketing partners.
OUR AGREEMENTS WITH KING REDUCE THE LIKELIHOOD THAT WE COULD BE ACQUIRED
BY ANOTHER COMPANY.
Our co-promotion agreement and license agreement with King for the
marketing of ESTRASORB and ANDROSORB contain several provisions that would take
effect upon a change of control of the Company. One provision allows King
several options in the event of a change in control of Novavax including (i)
terminating our right to co-promote King products, (ii) terminating our rights
to promote ESTRASORB and ANDROSORB and certain other hormone therapies for
women, or (iii) requiring Novavax to assign and transfer to King all related
rights of ownership for ESTRASORB and ANDROSORB and certain other hormone
replacement therapies for women and license to King on an exclusive and
perpetual basis all intellectual property rights and know-how. If King chooses
to exercise its rights under either clause (ii) or (iii) above, King will pay us
royalties on net sales of the products. In addition, King will pay us for the
cost of manufacturing, plus a markup consistent with the terms of the license
agreement for the handling costs. King could also require that we redeem the
outstanding promissory notes, currently in the amount of $40.0 million, at 101%
of the outstanding principal and accrued interest. These provisions may have the
effect of making us less attractive as an acquisition candidate.
WE NEED ADDITIONAL MANUFACTURING CAPABILITY TO COMMERCIALIZE OUR
PRODUCTS.
We do not have any experience with the large capacity manufacturing
required for commercial sale of a product. Although we have had the ability to
produce the limited quantities of products needed to support our current
research and development program and clinical trials (including utilizing
contract manufacturing organizations), we will need more production capacity for
larger, later-stage clinical studies and commercial sales. Our potential
products may be too difficult or costly to manufacture on a large scale, to
develop into commercially viable products or to market.
We have validated our manufacturing methods for ESTRASORB, which has
been produced in 100-kilo size batches. Such validation is required under FDA
guidelines, and we have received preliminary FDA approval of these methods. We
currently manufacture ESTRASORB at a facility of Cardinal Health, Inc. in
Philadelphia, Pennsylvania. In February 2002, we entered into an agreement with
Cardinal Health to lease approximately 24,000 square feet of space within their
facility. Under the terms of this agreement, Cardinal Health will also provide
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packaging services for the product we manufacture in their facility. We have
substantially completed the build out of the facility to meet our requirements
and have installed manufacturing equipment at this facility with the capacity
required for commercial production of ESTRASORB. Now that this new equipment is
installed, we need to validate that the ESTRASORB made using this new equipment
is identical to that used in our clinical trials. If we are unable to make
ESTRASORB on a commercial scale or are delayed in validating the product
manufactured with our new equipment, the commercialization of ESTRASORB would be
delayed.
In the near term, we will be manufacturing ESTRASORB only in the
Philadelphia facility. If ESTRASORB is approved by the FDA, we plan to qualify
at least one additional site for the manufacture of ESTRASORB. If we are unable
to utilize the Philadelphia facility to manufacture ESTRASORB prior to our
qualification of a second site, however, we would not have immediate access to
ESTRASORB and would be required to reestablish our validation process at a
different facility that would cause us to lose sales of ESTRASORB and would
adversely affect our business.
We currently utilize third party contract manufacturers to manufacture
our other products. Any contract manufacturer's facility that we may use,
including the Cardinal Health facility, must adhere to the FDA's regulations on
current good manufacturing practices, which are enforced by the FDA through its
facilities inspection program. These facilities are subject to periodic
inspection by the FDA. The manufacture of products at these facilities will be
subject to strict quality control testing and record-keeping requirements. We
may not be able to enter into alternative manufacturing arrangements at
commercially acceptable rates, if at all. Moreover, the manufacturers we use may
not provide sufficient quantities of product to meet our specifications or our
delivery, cost and other requirements.
If we decide to manufacture our own products, we will need to acquire
additional manufacturing facilities and to improve our manufacturing technology.
Establishing additional manufacturing facilities will require us to spend
substantial funds, hire and retain a significant number of additional personnel
and comply with extensive regulations applicable to such facilities here and
abroad, including the current good laboratory practices and good manufacturing
practices required by the FDA. If we elect to or need to manufacture our own
products, we risk the possibility that we may not be able to do so in a timely
fashion at acceptable quality and prices or in compliance with good laboratory
practices and good manufacturing practices.
WE HAVE NOT COMPLETED THE DEVELOPMENT OF MANY OF OUR PRODUCTS AND WE MAY
NOT SUCCEED IN OBTAINING THE FDA APPROVAL NECESSARY TO SELL ANY ADDITIONAL
PRODUCTS.
The development, manufacture and marketing of our pharmaceutical
products are subject to government regulation in the United States and other
countries. In the United States and most foreign countries, we must complete
rigorous preclinical testing and extensive human clinical trials that
demonstrate the safety and efficacy of a product in order to apply for
regulatory approval to market the product. Only a few of our products have been
approved for sale and our application to sell ESTRASORB in the United States is
currently being reviewed by the FDA. Our product candidate, ANDROSORB, has
completed two Phase I human clinical studies. Our other product candidates are
in preclinical laboratory or animal studies. Before applying for FDA approval to
market any additional product candidates, we must conduct larger-scale Phase II
and III human clinical trials that demonstrate the safety and efficacy of our
products to the satisfaction of the FDA or other regulatory authorities. These
processes are expensive and can take many years to complete. We may not be able
to demonstrate the safety and efficacy of our products to the satisfaction of
the FDA or other regulatory authorities. We may also be required to demonstrate
that our proposed products represent an improved form of treatment over existing
therapies and we may be unable to do so without conducting further clinical
studies.
We may fail to obtain regulatory approval for our products on a timely
basis. Delays in obtaining regulatory approval can be extremely costly in terms
of lost sales opportunities and increased clinical trial costs. The speed with
which we complete our clinical trials and our applications for marketing
approval will depend on several factors, including the following:
- the rate of patient enrollment, which is a function of many factors,
including the size of the patient population, the proximity of patients
to clinical sites, the eligibility criteria for the study and the nature
of the protocol;
-9-
- institutional review board approval of the protocol and the informed
consent form;
- prior regulatory agency review and approval;
- analysis of data obtained from preclinical and clinical activities that
are susceptible to varying interpretations, which interpretations could
delay, limit or prevent regulatory approval;
- changes in the policies of regulatory authorities for drug approval
during the period of product development; and
- the availability of skilled and experienced staff to conduct and monitor
clinical studies and to prepare the appropriate regulatory applications.
We have limited experience in conducting and managing the preclinical
and clinical trials necessary to obtain regulatory marketing approvals. We may
not be able to obtain the approvals necessary to conduct clinical studies. Also,
the results of our clinical trials may not be consistent with the results
obtained in preclinical studies or the results obtained in later phases of
clinical trials may not be consistent with those obtained in earlier phases. A
number of companies in the specialty pharmaceutical industry have suffered
significant setbacks in advanced clinical trials, even after experiencing
promising results in early animal and human testing. If regulatory approval of a
drug is granted, such approval is likely to limit the indicated uses for which
it may be marketed. Furthermore, even if a product of ours gains regulatory
approval, the product and the manufacturer of the product will be subject to
continuing regulatory review. We may be restricted or prohibited from marketing
or manufacturing a product, even after obtaining product approval, if previously
unknown problems with the product or its manufacture are subsequently
discovered.
OUR SUCCESS DEPENDS ON OUR ABILITY TO MAINTAIN THE PROPRIETARY NATURE OF
OUR TECHNOLOGY.
Our success will, in large part, depend on our ability to maintain the
proprietary nature of our technology and other trade secrets. To do so, we must
prosecute and maintain existing patents, obtain new patents and pursue trade
secret protection. We also must operate without infringing the proprietary
rights of third parties or letting third parties infringe our rights. We
currently have 55 U.S. patents and approximately 150 foreign patents and patent
applications covering our technologies. We recently filed eight new patent
applications in the US and worldwide directed towards innovative discoveries
made in the field of human Papillomavirus virus-like particles. However, patent
issues relating to pharmaceuticals involve complex legal, scientific and factual
questions. To date, no consistent policy has emerged regarding the breadth of
biotechnology patent claims that are granted by the United States Patent and
Trademark Office or enforced by the federal courts. Therefore, we do not know
whether our applications will result in the issuance of patents, or that any
patents issued to us will provide us with any competitive advantage. We also
cannot be sure that we will develop additional proprietary products that are
patentable. Furthermore, there is a risk that others will independently develop
or duplicate similar technology or products or circumvent the patents issued to
us.
There is a risk that third parties may challenge our existing patents or
may claim that we are infringing their patents or proprietary rights. We could
incur substantial costs in defending patent infringement suits or in filing
suits against others to have their patents declared invalid or claim
infringement. It is also possible that we may be required to obtain licenses
from third parties to avoid infringing third-party patents or other proprietary
rights. We cannot be sure that such third-party licenses would be available to
us on acceptable terms, if at all. If we are unable to obtain required
third-party licenses, we may be delayed in or prohibited from developing,
manufacturing or selling products requiring such licenses.
Although our patents include claims covering various features of our
product candidates, including composition, methods of manufacture and use, our
patents do not provide us with complete protection against the development of
competing products. For example, our patents do not prohibit third parties from
developing and selling products for estrogen replacement therapy that deliver
estrogen through a topical emulsion, ointment or similar medium.
-10-
Some of our know-how and technology is not patentable. To protect our
proprietary rights in unpatentable intellectual property and trade secrets, we
require employees, consultants, advisors and collaborators to enter into
confidentiality agreements. These agreements may not provide meaningful
protection for our trade secrets, know-how or other proprietary information in
the event of any unauthorized use or disclosure.
HEALTH CARE INSURERS AND OTHER PAYORS MAY NOT PAY FOR OUR PRODUCTS OR
MAY IMPOSE LIMITS ON REIMBURSEMENT.
Our ability to commercialize ESTRASORB and our future products will
depend, in part, on the extent to which reimbursement for such products will be
available from third-party payors, such as Medicare, Medicaid, health
maintenance organizations, health insurers and other public and private payors.
If we succeed in bringing ESTRASORB or other products in the future to market,
we cannot be assured that third-party payors will pay for ESTRASORB or will
establish and maintain price levels sufficient for realization of an appropriate
return on our investment in product development. For example, ESTRASORB, if
approved for commercial sale in the United States, would be sold as an
outpatient prescription drug. Medicare does not cover the costs of most
outpatient prescription drugs. We expect that ESTRASORB will be treated the same
as other estrogen replacement therapy products with respect to government and
third-party payor reimbursement. However, we cannot be assured that ESTRASORB
will receive similar reimbursement treatment.
Many health maintenance organizations and other third-party payors use
formularies, or lists of drugs for which coverage is provided under a health
care benefit plan, to control the costs of prescription drugs. Each payor that
maintains a drug formulary makes its own determination as to whether a new drug
will be added to the formulary and whether particular drugs in a therapeutic
class will have preferred status over other drugs in the same class. This
determination often involves an assessment of the clinical appropriateness of
the drug and sometimes the cost of the drug in comparison to alternative
products. We cannot be assured that ESTRASORB or any of our future products will
be added to payors' formularies, that our products will have preferred status to
alternative therapies, or that the formulary decisions will be conducted in a
timely manner. We may also decide to enter into discount or formulary fee
arrangements with payors, which could result in us receiving lower or discounted
prices for ESTRASORB or future products.
WE MAY HAVE PRODUCT LIABILITY EXPOSURE.
The administration of drugs to humans, whether in clinical trials or
after marketing clearances are obtained, can result in product liability claims.
We maintain product liability insurance coverage in the total amount of $18.0
million for claims arising from the use of our currently marketed products and
products in clinical trials prior to FDA approval. Coverage is becoming
increasingly expensive, however, and we may not be able to maintain insurance at
a reasonable cost. We cannot be assured that we will be able to maintain our
existing insurance coverage or obtain coverage for the use of our other products
in the future. This insurance coverage and our resources may not be sufficient
to satisfy liabilities resulting from product liability claims. A successful
claim may prevent us from obtaining adequate product liability insurance in the
future on commercially desirable terms, if at all. Even if a claim is not
successful, defending such a claim may be time-consuming and expensive and may
damage our reputation in the marketplace.
WE HAVE MADE LOANS TO CERTAIN OF OUR DIRECTORS, AND HAVE GUARANTEED A
BROKERAGE MARGIN LOAN FOR ONE OF THESE DIRECTORS THAT COULD HAVE A NEGATIVE
IMPACT ON OUR STOCK PRICE.
In 2002, pursuant to our Stock Option Plan, we approved the payment of
the exercise price of options by two directors through the delivery of full
recourse interest bearing promissory notes, in the aggregate amount of
approximately $1.5 million, secured by a pledge of the underlying shares. In
addition, in 2002 we executed a conditional guaranty of a brokerage margin
account for a director in the amount of $500,000. Due to heightened sensitivity
in the current environment surrounding related party transactions, these
transactions could be viewed negatively in the market and our stock price could
be negatively affected.
-11-
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 2002, our common stock traded in a range from a low of
$1.59 to a high of $14.00. In fiscal 2003, our common stock has traded in a
range from a low of $2.52 to a high of $6.87 as of August 8, 2003. It is likely
that the price of our common stock will fluctuate in the future. The market
prices of securities of small capitalization specialty pharmaceutical companies,
including ours, from time to time experience significant price and volume
fluctuations unrelated to the operating performance of particular companies. In
particular, over the next year, the market price of our common stock may
fluctuate significantly due to a variety of factors, including:
- governmental agency actions, including the FDA's determination with
respect to our pending NDA for ESTRASORB;
- our ability to obtain financing; and
- sales of our products, particularly ESTRASORB, if it is approved for
sale.
In addition, the occurrence of any of the risks described in this "Risk Factors"
section could have a dramatic and adverse impact on the market price of our
common stock.
OUR SUBSTANTIAL DEBT COULD ADVERSELY AFFECT OUR CASH FLOW AND PREVENT US
FROM FULFILLING OUR OBLIGATIONS.
We currently have $41.6 million of outstanding debt. Our substantial
amount of debt could have important consequences to you. For example, it:
- could increase our vulnerability to general adverse economic and
industry conditions;
- will require us to dedicate a substantial portion of our cash flow from
operations to service payments on our debt, reducing the availability of
our cash flow to fund future capital expenditures, working capital,
execution of our growth strategy, research and development costs and
other general corporate requirements;
- could limit our flexibility in planning for, or reacting to, changes in
our business and the pharmaceutical industry, which may place us at a
competitive disadvantage compared with competitors that have less debt;
and
- could limit our ability to borrow additional funds, even when necessary
to maintain adequate liquidity.
We may incur additional debt for various reasons, which, if over a
certain amount, must be approved by King. Any such additional debt could be
senior to the common stock being offered in this offering and would increase the
risks associated with our substantial leverage.
OUR INABILITY TO RECRUIT AND RETAIN MEMBERS OF OUR MANAGEMENT TEAM AND
KEY PERSONNEL COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS.
Our future success will depend in part on our ability to attract and
retain highly skilled employees, particularly those in management, sales,
regulatory, manufacturing and technical positions. The loss of services of
members of our management team could adversely affect our business and impede or
delay achievement of our corporate mission. Furthermore, recruiting and
retaining qualified scientific and other key employees will be critical to our
success, and competition for such employees in our targeted industry and in our
geographic regions is intense. In addition, many of the companies with which we
compete for highly qualified personnel have greater financial and other
resources than we do. We may be unable to attract and retain key employees on
acceptable terms given the level and nature of such competition.
-12-
ANTI-TAKEOVER PROVISIONS COULD MAKE A THIRD-PARTY ACQUISITION OF US MORE
DIFFICULT.
In 2002, we adopted a Shareholder Rights Plan that provided for the
issuance of rights to purchase shares of Series D Junior Participating Preferred
Stock of the Company. Under the plan, we distributed one preferred share
purchase right for each outstanding share of common stock. Each purchase right
entitles the holder to purchase from the Company one one-thousandth (1/1000th)
of a preferred share at a price of $40 per one one-thousandth (1/1,000th) of a
share, subject to adjustment. The rights become exercisable, with certain
exceptions, ten business days after any party, without prior approval of our
Board of Directors, acquires or announces an offer to acquire beneficial
ownership of 15% or more of the Company's common stock. In the event that any
party acquires 15% or more of the Company's common stock, the Company enters
into a merger or other business combination, or if a substantial portion of the
Company's assets is sold after the time that the rights become exercisable, the
rights provide that the holder will receive, upon exercise, shares of the common
stock of the surviving or acquiring company, as applicable, having a market
value of twice the exercise price of the right. The Shareholder Rights Plan may
discourage or prevent certain types of transactions involving an actual or
potential change in control, which transactions may be beneficial to our
shareholders, by causing substantial dilution to a party that attempts to
acquire us on terms not approved by our Board.
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ABOUT THIS PROSPECTUS
This prospectus is part of a "shelf" registration statement that we
filed with the Securities and Exchange Commission (the "SEC"). By using a shelf
registration statement, we may, from time to time, sell shares of our common
stock in one or more offerings with a maximum aggregate offering price of
$50,000,000. Each time we sell any of our common stock, we will provide a
prospectus supplement that will contain specific information about the offering.
This prospectus and the prospectus supplements provide you with a general
description of the company and our common stock; for further information about
our business and our securities, you should refer to the registration statement,
the reports incorporated by reference in this prospectus, and its exhibits. The
exhibits to our registration statement contain the full text of certain
contracts and other important documents we have summarized in this prospectus.
Since these summaries may not contain all the information that you may find
important in deciding whether to purchase the securities we may offer, you
should review the full text of these documents. The registration statement can
be obtained from the SEC as indicated under the heading "Where You Can Find More
Information."
You should rely only on the information contained or incorporated by
reference in this prospectus and the prospectus supplement. We have not
authorized anyone to provide you with different information. If anyone provides
you with different or inconsistent information, you should not rely on it. We
will not make an offer to sell these securities in any jurisdiction where the
offer or sale is not permitted. You should assume that the information appearing
in this prospectus, as well as information we previously filed with the SEC and
incorporated by reference in this prospectus, is accurate only as of the date on
the front cover of this prospectus. Our business, financial condition, results
of operations and prospects may have changed since that date.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We caution you that this prospectus contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
These statements are based on management's beliefs and assumptions and on
information currently available to management, and use words such as "expect,"
"anticipate," "intend," "plan," "believe," "estimate," "may," "could,"
"possible," "forecast," or similar words and expressions. Forward-looking
statements include information concerning possible or assumed future results of
operations, future product development and related clinical trials and
statements regarding future research and development. Forward-looking statements
are only predictions, and necessarily involve risks and uncertainties and other
factors that may cause the actual results, performance or achievements of
Novavax, or industry results, to be materially different from those anticipated
in the forward-looking statements. These risks and uncertainties are discussed
in the "Risk Factors" section and elsewhere in this prospectus.
-15-
USE OF PROCEEDS
Except as otherwise described in an applicable prospectus supplement, we
currently intend to use the net proceeds from this offering for general
corporate purposes, including but not limited to:
- our internal research and development programs, such as preclinical and
clinical testing and studies of our product candidates and the
development of new technologies,
- pre-launch, marketing, and other expenses related to product candidate
ESTRASORB, if approved by the FDA,
- general working capital, and
- possible future acquisitions of complementary businesses, product lines
or technologies, although no such transactions are currently under
negotiation.
We have not determined the amounts we plan to spend on any of the areas
listed above or the timing of these expenditures, which may vary significantly
depending on various factors such as our research and development results,
regulatory approvals, competition, marketing and sales, and the market
acceptance of any products introduced by us. As a result, our management will
have broad discretion to allocate the net proceeds from this offering. Pending
application of the net proceeds as described above, we intend to invest the net
proceeds of this offering in short-term, interest-bearing, investment-grade
securities.
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PLAN OF DISTRIBUTION
We may sell the securities being offered hereby from time to time in one
or more of the following ways:
- through one or more underwriters,
- 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),
- directly to one or more purchasers,
- through agents,
- in privately negotiated transactions, and
- in any combination of these methods of sale.
We will set forth in a prospectus supplement the terms of the offering of
securities, including:
- the name or names of any agents, underwriters or dealers,
- the purchase price of the common stock being offered and the proceeds we
will receive from the sale,
- any underwriting discounts and commissions or agency fees and other
items constituting underwriters' or agents' compensation,
- any over-allotment options under which underwriters may purchase
additional securities from us, and
- any discounts or concessions allowed or reallowed or paid to dealers.
The distribution of the common stock may be effected from time to time
in one or more transactions at a fixed price or prices, which may be changed, at
market prices prevailing at the time of sale, at prices related to the
prevailing market prices, or at negotiated prices.
Underwriters, dealers and agents that participate in the distribution of
the common stock may be underwriters as defined in the Securities Act of 1933,
as amended (the "Securities Act") and any discounts or commissions they receive
from us and any profit on their resale of the common stock may be treated as
underwriting discounts and commissions under the Securities Act. We will
identify in the applicable prospectus supplement any underwriters, dealers or
agents and will describe their compensation. We may have agreements with
underwriters, dealers and agents to indemnify them against specified civil
liabilities, including liabilities under the Securities Act. Underwriters,
dealers and agents may engage in transactions with or perform services for us in
the ordinary course of their businesses. We have not entered into any
agreements, understandings or arrangements with any underwriters or
broker-dealers regarding the sale of their securities. As of the date of this
prospectus, there are no special selling arrangements between any broker-dealer
or other person and the Company. No period of time has been fixed within which
the shares will be offered or sold.
If required under applicable state securities laws, we will sell the
common stock only through registered or licensed brokers or dealers. In
addition, in some states, we may not sell shares of common stock unless they
have been registered or qualified for sale in the applicable state or unless we
have complied with an exemption from any registration or qualification
requirements.
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AGENTS
We may designate agents who agree to solicit purchases for the period of
their appointment or to sell common stock on a continuing basis. Unless the
prospectus supplement provides otherwise, agents will act on a best efforts
basis for the period of their appointment. Agents may receive compensation in
the form of commissions, discounts or concessions from us. Agents may also
receive compensation from the purchasers of the common stock for whom they sell
as principals. Each particular agent will receive compensation in amounts
negotiated in connection with the sale, which might be in excess of customary
commissions.
UNDERWRITERS
If we use underwriters for a sale of common stock, the underwriters will
acquire the common stock for their own account. The underwriters may resell the
common stock in one or more transactions, including negotiated transactions, at
a fixed public offering price or at varying prices determined at the time of
sale. The obligations of the underwriters to purchase the common stock will be
subject to the conditions set forth in the applicable underwriting agreement.
Unless the prospectus supplement provides otherwise, underwriters will be
obligated to purchase all of the shares of common stock offered by the
prospectus supplement. We may change from time to time any initial public
offering price and any discounts or concessions the underwriters allow or
reallow or pay to dealers. We may use underwriters with whom we have a material
relationship, and we may offer the securities to the public through an
underwriting syndicate or through a single underwriter. We will describe in the
prospectus supplement naming the underwriter the nature of any such relationship
and underwriting arrangement.
DEALERS
We also may sell securities to a dealer as principal. If we sell our
common stock to a dealer as a principal, then the dealer may resell those shares
to the public at varying prices to be determined by such dealer at the time of
resale. The name of the dealer and the terms of the transactions will be set
forth in the applicable prospectus supplement.
DIRECT SALES AND INSTITUTIONAL PURCHASES
We may also sell common stock directly to one or more purchasers, in
which case underwriters or agents would not be involved in the transaction.
Further, we may authorize agents, underwriters or dealers to solicit
offers by certain types of institutional investors to purchase common stock from
us at the public offering price set forth in the prospectus supplement pursuant
to delayed delivery contracts providing for payment and delivery on a specified
date in the future. We will describe the conditions to these contracts and the
commissions we must pay for solicitation of these contracts in the prospectus
supplement.
STABILIZATION ACTIVITIES
Any underwriter may engage in overallotment, stabilizing transactions,
short covering transactions and penalty bids in accordance with Regulation M
under the Exchange Act of 1934, as amended (the "Exchange Act"). Overallotment
involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long
as the stabilizing bids do not exceed a specified maximum. Short covering
transactions involve purchases of the common stock in the open market after the
distribution is completed to cover short positions. Penalty bids permit the
underwriters to reclaim a selling concession from a dealer when the common stock
originally sold by the dealer are purchased in a covering transaction to cover
short positions. Those activities may cause the price of the common stock to be
higher than it would otherwise be. If commenced, the underwriters may
discontinue any of the activities at any time. These transactions may be
effected on the Nasdaq Stock Market or otherwise.
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PASSIVE MARKET MAKING
Any underwriters who are qualified market markers on the Nasdaq National
Market may engage in passive market making transactions in the common stock on
the Nasdaq National Market in accordance with Rule 103 of Regulation M, during
the business day prior to the pricing of the offering, before the commencement
of offers or sales of the common stock. Passive market makers must comply with
applicable volume and price limitations and must be identified as passive market
makers. In general, a passive market maker must display its bid at a price not
in excess of the highest independent bid for such security; if all independent
bids are lowered below the passive market maker's bid, however, the passive
market maker's bid must then be lowered when certain purchase limits are
exceeded.
COSTS
We will bear all costs, expenses and fees in connection with the
registration of the common stock, as well as the expense of all commissions and
discounts, if any, attributable to the sales of the common stock by us.
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DESCRIPTION OF OUR CAPITAL STOCK
Our authorized capital stock consists of: (i) 50,000,000 shares of
common stock, par value $.01 per share, of which 30,142,300 shares were
outstanding as of August 8, 2003, and (ii) 2,000,000 shares of preferred stock,
par value $.01 per share, none of which are outstanding.
Our common stock is traded on the Nasdaq National Market under the
symbol NVAX. On August 8, 2003, the closing price of our common stock as
reported on the Nasdaq National Market was $5.66 per share.
COMMON STOCK
Holders of common stock are entitled to one vote for each share held on
all matters submitted to a vote of stockholders and do not have cumulative
voting rights. Accordingly, holders of a majority of the shares of our common
stock entitled to vote in any election of directors may elect all of the
directors standing for election. Holders of our common stock are entitled to
receive ratably such dividends, if any, as may be declared by the Board of
Directors out of funds legally available therefor, subject to any preferential
dividend rights of any outstanding preferred stock. Upon the liquidation,
dissolution or winding up of our Company, the holders of our common stock are
entitled to receive ratably the net assets of our Company available after the
payment of all debts and liabilities and subject to the prior rights of any
outstanding preferred stock. Shares of our common stock are, and the shares
being distributed in this offering will be, when issued, fully paid and
nonassessable. The rights, preferences and privileges of holders of our common
stock are subject, and may be adversely affected by, the rights of holders of
shares of any series of preferred stock which we may designate and issue in the
future.
PREFERRED STOCK
The Board of Directors may, without further action by the stockholders
of our Company, issue preferred stock in one or more series and fix the rights
and preferences thereof, including the dividend rights, dividend rates,
conversion rights, voting rights, pre-emptive rights, terms of redemption
(including sinking fund provisions), redemption prices and liquidation
preferences. Our Amended and Restated Certificate of Incorporation grants the
Board of Directors authority to issue preferred stock and to determine its
rights and preferences without the need for further stockholder approval to
eliminate delays associated with a stockholder vote on specific issuances. The
issue of preferred stock, while providing desirable flexibility in connection
with possible financings, could have the effect of making it more difficult for
a third party to acquire, or of discouraging a third party from acquiring, a
majority of the outstanding voting stock of our Company. We have no present
plans to issue any shares of preferred stock.
OPTIONS AND WARRANTS
The Novavax 1995 Stock Option Plan (the "Plan") was adopted by the Board
of Directors and approved by the stockholders in September, 1995 and will
terminate in 2005. The Plan was amended by resolution of the Board of Directors
adopted in March 1998 and approved by the stockholders in May 1998 to increase
the number of shares as to which options may be granted from 4,000,000 to
4,400,000. The Plan was again amended by resolution of the Board of Directors
adopted in March 2000 and approved by the stockholders in May 2000 to increase
the number of shares as to which options may be granted from 4,400,000 to
6,000,000. The Plan was again amended by resolution of the Board of Directors
adopted in March 2002 and approved by the stockholders in May 2002 to increase
the number of shares as to which options may be granted from 6,000,000 to
8,000,000. Most recently, the Plan was amended by resolution of the Board of
Directors adopted in March 2003 and approved by the stockholders in May 2003 to
increase the number of shares as to which options may be granted from 8,000,000
to 9,000,000.
Options granted under the Plan may be either incentive stock options
within the meaning of Section 422 of the Internal Revenue Code of 1986, as
amended, or options that do not meet the requirements for incentive stock option
treatment, to officers, directors, employees and consultants or advisors to our
Company and any present or future subsidiary to purchase a maximum of 9,000,000
shares of our common stock. As of August 8, 2003, under both this plan and a
prior stock option plan for directors, there were outstanding options to
purchase 4,684,908 shares of our common stock at an average exercise price of
$5.46 per share. There were 1,819,009 shares available for future grant as of
August 8, 2003.
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In addition, we have granted warrants to consultants. At August 8, 2003,
there were outstanding warrants to purchase 70,000 shares of our common stock at
an exercise price of $6.00 per share.
CONVERTIBLE NOTES
We have issued four convertible notes to King Pharmaceuticals, Inc. that
are currently convertible into an aggregate of 5,075,241 shares of our common
stock. The conversion price of each of the notes represents an 18% premium to
the 20 day trading average preceding the agreed-upon lock-in dates prior to the
issuance of each of the notes. The notes carry a 4% coupon payable semi-annually
in cash and stock. The notes allow the Company the option, under certain
circumstances, to pay up to 50% of the interest due in our common stock.
We can require King to convert the notes into our common stock at any
time from January 1, 2002 through December 31, 2004 if the closing price of our
common stock exceeds 180% of the conversion price then in effect for at least 30
trading days in any period of 45 consecutive trading days. After December 31,
2004, we can redeem the notes at 102%, 101% and 100% of face value during the
years ended December 31, 2005, 2006 and 2007, respectively.
SHAREHOLDER RIGHTS PLAN
We have adopted a Shareholder Rights Plan pursuant to which the Board of
Directors declared a dividend distribution of one preferred stock purchase right
for each outstanding share of common stock. Each right, once exercisable,
entitles the holder to purchase from us one one-thousandth (1/1,000th) of a
share of Series D Junior Participating Preferred Stock (the "Preferred Stock"),
at a price of $40.00, subject to certain adjustments.
The rights, unless earlier redeemed by the Board, become exercisable
upon the close of business on the day which is the earlier of (i) the tenth
business day following a public announcement that a person or group of
affiliated or associated persons (with certain exceptions) has acquired
beneficial ownership of 15% or more of the outstanding voting stock of the
Company, and (ii) the tenth business day after the date of the commencement by
any person of a tender or exchange offer, the consummation of which would result
in such person or group of affiliated or associated persons becoming an
"acquiring person" as defined in the rights plan. The rights expire at the close
of business on August 7, 2012, unless earlier redeemed or exchanged by us as
described below.
Unless the rights are earlier redeemed, in the event that a person or
group becomes an "acquiring person," the rights plan provides that proper
provisions will be made so that each holder of record of a right (other than
rights beneficially owned by an acquiring person and certain of its affiliates,
associates and transferees) will thereafter have the right to receive, upon
payment of the exercise price, that number of shares of the Preferred Stock
having a fair market value determined in accordance with the rights plan at the
time of the transaction equal to approximately two times the exercise price
(such value to be determined with reference to the fair market value of our
common stock as provided in the rights plan).
In addition, unless the rights are earlier redeemed or exchanged, in the
event that, after the time that a person or group becomes an acquiring person,
we were to be acquired in a merger or other business combination (in which any
shares of common stock are changed into or exchanged for other securities or
assets) or more than 50% of the assets or earning power of the Company and its
subsidiaries (taken as a whole) were to be sold or transferred in one or a
series of related transactions, the rights plan provides that proper provision
will be made so that each holder of record of a right (other than rights
beneficially owned by an acquiring person and certain of its affiliates,
associates and transferees) will have the right to receive, upon payment of the
exercise price, that number of shares of common stock of the acquiring company
having a fair market value at the time of such transaction determined in
accordance with the rights plan equal to approximately two times the exercise
price.
At any time after any person or group becomes an acquiring person and
prior to the acquisition by such person or group of 50% or more of the
outstanding voting stock, the Board may exchange the rights, in whole or in
part, for that number of shares of the Preferred Stock having a fair market
value on the date such person or group became an acquiring person equal to the
excess of (i) the fair market value of Preferred Stock issuable upon the
exercise of the rights over (ii) the exercise price of the rights, in each case
subject to anti-dilution adjustments.
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At any time prior to the close of business on the tenth business day
after there has been a public announcement that a person has become an acquiring
person or such earlier date as a majority of the Board shall become aware of the
existence of an acquiring person, we may redeem the rights in whole, but not in
part, at a price of $.001 per right. Immediately upon the effective time of such
Board action, the right to exercise the rights will terminate and the only right
of the holders will be to receive the redemption price.
For as long as the rights are then redeemable, we may, except with
respect to the redemption price, amend the rights in any manner, including
extending the time period in which the rights may be redeemed. At any time when
the rights are not then redeemable, we may amend the rights in any manner that
does not materially adversely affect the interests of holders of the rights as
such.
TRANSFER AGENT
Our registrar and transfer agent for all shares of common stock is
Equiserve, 150 Royall Street, Canton, MA 02021.
DIVIDEND POLICY
We have never paid cash dividends on our common stock. We currently
anticipate that we will retain all of our earnings for use in the development of
our business and do not anticipate paying any cash dividends in the foreseeable
future.
LEGAL MATTERS
Certain legal matters with respect to the shares of common stock offered
hereby have been passed upon by White White & Van Etten LLP, 55 Cambridge
Parkway, Cambridge, Massachusetts 02142. David A. White, a partner of such firm,
owns 50,000 shares of our common stock.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year
ended December 31, 2002, as set forth in their report, which is incorporated by
reference in this prospectus and elsewhere in the registration statement. Our
financial statements are incorporated by reference in reliance on Ernst & Young
LLP's 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
SEC's Public Reference Room located at 450 Fifth Street, N.W., Washington, D.C.
You can request copies of these documents, for a copying fee, by writing to the
SEC. Please call the SEC at 1-800-SEC-0330 or visit the SEC's website for more
information about the operation of the public reference rooms. Our filings with
the SEC are also available to you over the Internet at the SEC's web site at
http://www.sec.gov.
Our common stock is traded as "National Market Securities" on the Nasdaq
National Market under the symbol NVAX. Materials we file can also be inspected
at the offices of Nasdaq Operations at 1735 K Street, Washington, D.C. 20006.
We have filed a registration statement on Form S-3 (together with all
amendments and exhibits, which we refer to as the registration statement) with
the SEC under the Securities Act with respect to the common shares offered by
this prospectus. This prospectus, which constitutes a part of the registration
statement, does not contain all the information in the registration statement.
For further information about us and our securities, see the registration
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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" the information we file
with it, which means that we can disclose important information to you by
referring you to those documents. This prospectus is part of a registration
statement we filed with the SEC. You should rely on the information incorporated
by reference in this prospectus and the registration statement. The information
incorporated by reference is considered to be part of this prospectus and
information we file later with the SEC will automatically update and supersede
this information. We incorporate by reference the documents listed below and any
future filings made with the SEC under Section 13(a), 13(c), 14 or 15(d) of the
Exchange Act until the selling stockholders sell all of their shares of common
stock or the offering is otherwise terminated. The documents we are
incorporating by reference are:
1. Our Annual Report on Form 10-K for the fiscal year ended
December 31, 2002, as filed with the SEC on March 28, 2003;
2. Quarterly Reports on Form 10-Q for the quarters ended:
a. March 31, 2003, as filed with the SEC on May 15, 2003;
b. June 30, 2003, as filed with the SEC on August 13, 2003;
and
c. September 30, 2003, as filed with the SEC on November
12, 2003.
3. Current Reports on Form 8-K filed with the SEC on May 14, 2003
and August 8, 2003;
4. Definitive Proxy Statement with respect to the Annual Meeting of
Stockholders held on May 7, 2003, as filed with the SEC on March
31, 2003;
5. The description of our common stock contained in the
Registration Statement on Form 10 filed with the SEC on
September 14, 1995; and
6. All other reports filed by us under Section 13(a) or 15(d) of
the Exchange Act since the end of our fiscal year ended December
31, 2002.
You may request a copy of these filings at no cost by writing or
telephoning our chief financial officer at the following address and telephone
number: Novavax, Inc., 8320 Guilford Road, Columbia, MD 21046; (301) 854-3900.
Attn: Dennis Genge.
We undertake no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or otherwise.
You are advised, however, to consult any further disclosures we make on related
subjects in our 10-Q, 8-K and 10-K reports to the SEC. Also note that we provide
a cautionary discussion of risks and uncertainties relevant to our business in
the "Risk Factors" section of this prospectus. These are factors that we think
could cause our actual results to differ materially from expected results. Other
factors besides those listed here could also adversely affect us. This
discussion is provided as permitted by the Private Securities Litigation Reform
Act of 1995.
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