As
filed with the Securities and Exchange Commission on March 25,
2010
Registration
No. 333-165496
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
AMENDMENT
NO. 1 TO
FORM
S-3
REGISTRATION
STATEMENT UNDER
THE
SECURITIES ACT OF 1933
Novavax,
Inc.
(Exact
Name of Registrant as Specified in Its Charter)
|
22-2816046
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S. Employer
Identification Number)
|
9920
Belward Campus Drive
Rockville,
Maryland 20850
(240)
268-2000
(Address,
Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s
Principal Executive Offices)
Frederick
W. Driscoll
Vice
President, Chief Financial Officer and Treasurer
Novavax,
Inc.
9920
Belward Campus Drive
Rockville,
Maryland 20850
(240)
268-2000
(Name,
Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent
For Service)
With a copy
to:
Jennifer
L. Miller
Ballard
Spahr LLP
1735
Market Street
51st
Floor
Philadelphia,
Pennsylvania 19103
(215)
665-8500
Approximate
date of commencement of proposed sale to the public: From time to
time after this registration statement becomes effective.
If the
only securities being registered on this Form are being offered pursuant to
dividend or interest reinvestment plans, please check the following
box. o
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other
than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. x
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If this
Form is a registration statement filed pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. o
If this
form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act (Check one):
|
|
|
Large
Accelerated Filer ¨
|
|
Accelerated
Filer x
|
Non-Accelerated
Filer ¨
|
|
Smaller
Reporting Company ¨
|
CALCULATION
OF REGISTRATION FEE
Title of each class of securities to be registered
|
|
|
Amount to be
registered(1)(2)
|
|
Proposed maximum
aggregate price per
unit(2)
|
|
|
Proposed maximum
aggregate offering
price(2)(3)
|
|
|
Amount of
Registration fee
|
Common
Stock, $0.01 par value(4)(5)
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
Stock, $0.01 par value(4)
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
|
|
|
|
|
|
|
|
|
|
|
|
Units
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
150,000,000
|
|
—
|
|
$ |
150,000,000
|
|
$ |
10,695
|
(1)
|
There
are being registered hereunder such indeterminate number of shares of
common stock and preferred stock of Novavax, Inc. (“Novavax”), such
indeterminate number of warrants to purchase common stock or preferred
stock of Novavax, and such indeterminate number of units consisting of any
two or more of the other securities listed in the table above and sold
together as shall have an aggregate initial offering price not to exceed
$150,000,000 or the equivalent thereof in one or more
currencies.
|
(2)
|
Not
specified as to each class of securities to be registered hereunder
pursuant to General Instruction II.D. of Form S-3. Any securities
registered hereunder may be sold separately or as units with other
securities registered hereunder. The proposed maximum offering price per
unit will be determined from time to time by the Registrant in connection
with, and at the time of, the issuance of the
securities.
|
(3)
|
Estimated
solely for the purpose of calculating the amount of the registration fee
required pursuant to Rule 457(o) thereof, which permits the registration
fee to be calculated on the basis of the maximum aggregate offering price
of all securities listed.
|
(4)
|
Also
includes an indeterminate number of shares of common stock that may be
issued upon conversion or exercise, as applicable, of preferred stock or
warrants registered hereunder and an indeterminate number of shares of
preferred stock that may be issued upon exercise of warrants registered
hereunder.
|
(5)
|
Each
share of common stock includes a right to purchase Series D Junior
Participating Preferred Stock attached to the common
stock.
|
THE
REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS
MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A
FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
EXPLANATORY
NOTE
This
registration statement contains two prospectuses:
|
·
|
a
basic prospectus which covers both (i) the offering, issuance and sale of
$150,000,000 of common stock, preferred stock, warrants and units of
Novavax, Inc. by the registrant;
and
|
|
·
|
a
sales agreement prospectus covering the offering, issuance and sale of our
common stock that may be issued and sold under a sales agreement with
McNicoll, Lewis & Vlak LLC.
|
The basic
prospectus immediately follows this explanatory note. The sales agreement
prospectus immediately follows the basic prospectus. The common stock that may
be offered, issued and sold under the sales agreement prospectus is included in
the $150,000,000 of securities that may be offered, issued and sold by the
registrant under the basic prospectus.
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted.
Subject
to Completion, Dated March 25, 2010
PROSPECTUS
$150,000,000
Common
Stock
Preferred
Stock
Warrants
Units
We may
issue and sell from time to time our common stock, preferred stock, warrants
and/or units consisting of two or more of any such securities on terms to be
determined at the time of sale. The preferred stock may be convertible into
shares of our common stock and the warrants may be exercisable for shares of our
common stock or shares of our preferred stock. We may offer these securities
separately or together in one or more offerings with a maximum aggregate
offering price of $150,000,000.
We will
provide a prospectus supplement each time we issue securities, specifying the
specific terms of the securities being sold as well as the specific terms of
that offering.
You
should read this prospectus and any prospectus supplement, including any
information incorporated herein and therein, carefully before you
invest.
The
securities being sold may be sold on a delayed or continuous basis directly by
us, through dealers, agents or underwriters designated from time to time, or
through any combination of these methods. If any dealers, agents or underwriters
are involved in the sale of the securities in respect of which this prospectus
is being delivered, we will disclose their names and the nature of our
arrangements with them in any prospectus supplement. The net proceeds we expect
to receive from any such sale will also be included in the applicable prospectus
supplement.
Our
common stock is traded on the NASDAQ Global Market under the symbol NVAX. On
March 11, 2010, the closing price of our common stock as reported on the NASDAQ
Global Market was $2.48 per share. None of the other securities offered under
this prospectus are publicly traded.
Investing in our
securities involves a high degree of risk. See “RISK FACTORS” beginning on page
2.
This
prospectus may not be used to offer or sell securities unless accompanied by a
prospectus supplement for the securities being sold.
Neither
the Securities and Exchange Commission nor any other regulatory body has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus. Any representation to the contrary is a criminal
offense.
The
date of this Prospectus is _______, 2010.
TABLE
OF CONTENTS
NOVAVAX,
INC.
|
2
|
RISK
FACTORS
|
2
|
ABOUT
THIS PROSPECTUS
|
2
|
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
3
|
USE
OF PROCEEDS
|
4
|
PLAN
OF DISTRIBUTION
|
4
|
DESCRIPTION
OF OUR CAPITAL STOCK
|
7
|
DESCRIPTION
OF OUR WARRANTS
|
11
|
DESCRIPTION
OF OUR UNITS
|
13
|
DIVIDEND
POLICY
|
14
|
LEGAL
MATTERS
|
14
|
EXPERTS
|
14
|
WHERE
YOU CAN FIND MORE INFORMATION
|
14
|
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
|
15
|
You
should rely only on the information contained in this prospectus and in any
prospectus supplement (including in any documents incorporated by reference
herein or therein). We have not authorized anyone to provide you with any
different information. We are offering to sell our securities, and seeking
offers to buy, only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus and any prospectus supplement is
accurate only as of the date of this prospectus or such prospectus supplement,
and the information contained in any document incorporated herein or therein by
reference is accurate only as of the date of such document incorporated by
reference, regardless of the time of delivery or any sale of our
securities.
NOVAVAX,
INC.
Novavax,
Inc. (“Novavax,” the “Company,” “we” or “us”) is a biopharmaceutical company
focused on developing novel, highly potent recombinant vaccines. Our goal is to
become a profitable vaccine company that is aggressively driving towards
development, licensure and commercialization of important vaccine
candidates.
Our
technology platform is based on proprietary virus-like particles (VLPs). Our
VLPs are genetically engineered three-dimensional nanostructures, which
incorporate immunologically important recombinant proteins. Recombinant
protein-based vaccines are widely used and accepted. Examples of vaccines
currently available that use recombinant protein particle technology include
Recombivax® HB (Merck) and Engerix® (GlaxoSmithKline), which protect against
Hepatitis B, and Gardasil® (Merck) and Cervarix® (GlaxoSmithKline), which
protect against human papilloma virus. Our product pipeline targets several
infectious diseases. Currently, we have vaccine product candidates to target
pandemic influenza (both H1N1 and H5N1 strains), seasonal influenza, Respiratory
Syncytial Virus (RSV) and Varicella Zoster Virus (VZV).
Novavax
was incorporated in 1987 under the laws of the State of Delaware. Our
principal executive offices are located at 9920 Belward Campus Drive, Rockville,
Maryland, 20850. Our telephone number is (240) 268−2000 and our
website address is www.novavax.com. The contents of our website are
not part of this prospectus. The information on or accessible through
our website is not incorporated by reference into this filing.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. You should consider carefully
the risks incorporated by reference herein that are described under “Risk
Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2009, as well as any applicable prospectus supplement and the
reports we file from time to time with the SEC that are incorporated by
reference in this prospectus. If any of the events described in such “Risk
Factors” section occurs or the risks described in such “Risk Factors” section
actually materialize, our business, financial condition, results of operations,
cash flow or prospects could be materially adversely affected.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a “shelf” registration statement that we filed with the
Securities and Exchange Commission (the “SEC” or “Commission”). By using a shelf
registration statement, we may, from time to time, issue and sell in one or more
series or classes our common stock, preferred stock, warrants and/or units
consisting of our common stock, preferred stock and warrants in one or more
offerings up to an aggregate maximum offering price of $150,000,000 (or its
equivalent in foreign or composite currencies). Each time we sell any of our
securities, we will provide a prospectus supplement that will contain more
specific information about the offering and the terms of the securities being
sold. We may also add, update or change in the prospectus supplement any of the
information contained in this prospectus or the documents incorporated by
reference.
This
prospectus and the prospectus supplements provide you with a general description
of the Company and our securities; for further information about our business
and our securities, you should refer to the registration statement, the reports
incorporated by reference in this prospectus, as described in “Where You Can
Find More Information.”
You
should rely only on the information contained in this prospectus and in any
prospectus supplement (including in any documents incorporated by reference
herein or therein). We have not authorized anyone to provide you with any
different information. We are offering to sell our securities, and seeking
offers to buy, only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus and any prospectus supplement is
accurate only as of the date of this prospectus or such prospectus supplement,
and the information contained in any document incorporated herein or therein by
reference is accurate only as of the date of such document incorporated by
reference, regardless of the time of delivery or any sale of our
securities.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents we have filed with the Securities and Exchange
Commission, or SEC, that are incorporated herein by reference and that are
referenced under the section entitled “Where You Can Find More Information”,
contain “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements include,
but are not limited to, statements relating to future financial or business
performance, conditions or strategies and other financial and business matters,
including expectations regarding operating expenses, use of cash, and clinical
developments and anticipated milestones, including a BARDA contract, Phase 3
studies and seeking approval in Mexico, and include words such as “expect(s)”,
“intends”, “plans”, “seeks”, “estimates”, “could”, “should”, “feel(s)”,
“believe(s)”, “will”, “would”, “may”, “can”, “anticipate(s)”, “potential”, and
similar expressions or the negative of these terms, are based upon management’s
current expectations and beliefs. Such forward-looking statements are
not guarantees of future performance, involve known and unknown risks,
uncertainties and other factors which may cause the actual results, performance
or achievements of the Company, or industry results, to be materially different
from those expressed or implied by such forward-looking statements.
Factors
that may cause actual results to differ materially from the results discussed in
the forward-looking statements or historical experience include, among other
things, the following: our ability to progress any product candidates
into pre-clinical or clinical trials; the scope, initiation, rate and progress
of our pre-clinical studies and clinical trials and other research and
development activities; clinical trial results; even if the data from
pre-clinical studies or clinical trials is positive, the product may not prove
to be safe and efficacious; regulatory approval is needed before any vaccines
can be sold in or outside the United States and, to date, no governmental
authority has approved any of our vaccine candidates for sale; influenza is
seasonal in nature, and if approval or commercial launch after approval is not
timely in relation to the influenza season, we may not be able to manufacture or
sell our influenza vaccines on terms favorable to us until the next influenza
season, if at all; we have not manufactured any of our vaccine candidates at a
commercial level; we utilize a unique
manufacturing process and the scale-up of that process may prove difficult and
costly; our dependence on third parties to manufacture and distribute our
vaccines; risks associated with conducting business outside of the United
States; our ability to enter into future collaborations with industry partners
and the terms, timing and success of any such collaboration; our ability to
obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity or debt financing or
otherwise; the inability to win any government grants, including BARDA in a
timely manner or at all and other factors referenced herein.
All
forward-looking statements contained in this prospectus are based on information
available to the Company on the date hereof, and the Company assumes no
obligation to update any such forward-looking statements, except as specifically
required by law. Accordingly, past results and trends should not be used to
anticipate future results or trends.
USE
OF PROCEEDS
Except as
otherwise described in an applicable prospectus supplement, we currently intend
to use the net proceeds from this offering for general corporate purposes, which
may include:
|
·
|
clinical
development of our VLP-based vaccines, including the development of
appropriate adjuvants and demonstration of large-scale manufacturing
capabilities for such vaccines;
|
|
·
|
our
internal research and development programs, such as preclinical and
clinical testing and studies of our product candidates and the development
of new technologies and product
candidates;
|
|
·
|
expansion
of and investment in our research and development facilities, including
compliance with current Good Manufacturing Practices (cGMP) and Good
Laboratory Practices (GLP) rules and regulations;
and
|
|
·
|
general
working capital.
|
Each time
we issue securities, we will provide a prospectus supplement that will contain
information about how we intend to use the proceeds from each such
offering.
At this
time, we have not determined the specific uses of any offering proceeds, or the
amounts we plan to spend on any particular use or the timing of such
expenditures, which may vary significantly depending on various factors such as
our research and development results, regulatory approvals, competition,
marketing and sales, and the market acceptance of any products introduced by us
or our partners. Pending application of the net proceeds from any particular
offering, we intend to invest such proceeds in short-term, interest-bearing,
investment-grade securities.
We cannot
guarantee that we will receive any proceeds in connection with any offering
hereunder because we may choose not to issue any of the securities covered by
this prospectus.
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
registered direct offerings;
|
|
·
|
as
part of a collaboration with a third
party;
|
|
·
|
through
at the market issuances;
|
|
·
|
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
terms of the securities being offered, including the purchase price 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 securities may be effected from time to time in one or more
transactions at a fixed price or prices, which may be changed, at market prices
prevailing at the time of sale, at prices related to the prevailing market
prices, or at negotiated prices.
Underwriters,
dealers, agents and others that participate in the distribution of the
securities may be underwriters as defined in the Securities Act of 1933, as
amended (the “Securities Act”) and any discounts or commissions they receive
from us and any profit on their resale of the securities may be treated as
underwriting discounts and commissions under the Securities Act. We will
identify in the applicable prospectus supplement any underwriters, dealers,
agents and others and will describe their compensation. We may have agreements
with underwriters, dealers, agents and others to indemnify them against
specified civil liabilities, including liabilities under the Securities Act.
Underwriters, dealers, agents and others may engage in transactions with or
perform services for us in the ordinary course of their businesses.
Pursuant
to the terms of a letter of understanding among us, Piper Jaffray & Co.
(“Piper Jaffray”), Lazard Capital Markets (“LCM”) and Lazard Freres &
Co., LLC (“Lazard”), dated November 10, 2009, if, during the six month
period following the termination or expiration of such letter of understanding,
we propose to effect a public offering, Rule 144A offering or any private
placement of our securities, then we have agreed to offer to engage each of
Piper Jaffray, LCM and Lazard in underwriting as our bookrunner or bookrunning
lead placement agent, as the case may be, in connection with such transaction on
terms and conditions customary to Piper Jaffray, LCM and Lazard in similar
transactions. Each of Piper Jaffray, LCM or Lazard may decline such engagement
in its sole and absolute discretion. This restriction will not apply to any
offering of our common stock pursuant to an At the Market Sales Agreement with
McNicoll, Lewis & Vlak LLC. This letter of understanding expired on November
25, 2009. We have not entered into any other agreements, understandings or
arrangements with any other underwriters, broker-dealers or other parties
regarding the sale of securities. As of the date of this prospectus, there were
no other special selling arrangements between any broker-dealer or other person
and the Company. No period of time has been fixed within which the securities
will be offered or sold.
If
required under applicable state securities laws, we will sell the securities
only through registered or licensed brokers or dealers. In addition, in some
states, we may not sell securities unless they have been registered or qualified
for sale in the applicable state or unless we have complied with an exemption
from any registration or qualification requirements.
Agents
We may
designate agents who agree to solicit purchases for the period of their
appointment or to sell securities on a continuing basis. Unless the prospectus
supplement provides otherwise, agents will act on a best efforts basis for the
period of their appointment. Agents may receive compensation in the form of
commissions, discounts or concessions from us. Agents may also receive
compensation from the purchasers of the securities for whom they sell as
principals. Each particular agent will receive compensation in amounts
negotiated in connection with the sale, which might be in excess of customary
commissions.
Underwriters
If we use
underwriters for a sale of securities, the underwriters will acquire the
securities for their own account. The underwriters may resell the securities in
one or more transactions, including negotiated transactions, at a fixed public
offering price or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be subject to
the conditions set forth in the applicable underwriting agreement. Unless the
prospectus supplement provides otherwise, underwriters will be obligated to
purchase all of the securities offered by the prospectus supplement. We may
change from time to time any initial public offering price and any discounts or
concessions the underwriters allow or reallow or pay to dealers. We may use
underwriters with whom we have a material relationship, and we may offer the
securities to the public through an underwriting syndicate or through a single
underwriter. We will describe in the prospectus supplement naming the
underwriter the nature of any such relationship and underwriting
arrangement.
Dealers
We also
may sell securities to a dealer as principal. If we sell our securities to a
dealer as a principal, then the dealer may resell those securities to the public
at varying prices to be determined by such dealer at the time of resale. The
name of the dealer and the terms of the transactions will be set forth in the
applicable prospectus supplement.
Direct
Sales and Institutional Purchases
We may
also sell securities directly to one or more purchasers, in which case
underwriters or agents would not be involved in the transaction.
Further,
we may authorize agents, underwriters or dealers to solicit offers by certain
types of institutional investors to purchase securities from us at the public
offering price set forth in the prospectus supplement pursuant to delayed
delivery contracts providing for payment and delivery on a specified date in the
future. We will describe the conditions to these contracts and the commissions
we must pay for solicitation of these contracts in an applicable prospectus
supplement.
Stabilization
Activities
Any
underwriter may engage in overallotment, stabilizing transactions, short
covering transactions and penalty bids in accordance with Regulation M
under the Exchange Act of 1934, as amended (the “Exchange Act”). Overallotment
involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long
as the stabilizing bids do not exceed a specified maximum. Short covering
transactions involve purchases in the open market after the distribution is
completed to cover short positions. Penalty bids permit the underwriters to
reclaim a selling concession from a dealer when the securities originally sold
by the dealer are purchased in a covering transaction to cover short positions.
Such activities may cause the price of the securities to be higher than they
would otherwise be. If commenced, the underwriters may discontinue any of the
activities at any time. These transactions may be effected on the NASDAQ Global
Market or otherwise.
Passive
Market Making
Any
underwriters who are qualified market makers on the NASDAQ Global Market may
engage in passive market making transactions on the NASDAQ Global Market in
accordance with Rule 103 of Regulation M, during the business day
prior to the pricing of the offering, before the commencement of offers or
sales. Passive market makers must comply with applicable volume and price
limitations and must be identified as passive market makers. In general, a
passive market maker must display its bid at a price not in excess of the
highest independent bid for such security; if all independent bids are lowered
below the passive market 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
securities, as well as the expense of all commissions and discounts, if any,
attributable to sales of the securities by us.
DESCRIPTION
OF OUR CAPITAL STOCK
Set forth
below is a summary of the material terms of our capital stock. This summary is
not complete. We encourage you to read our Amended and Restated Certificate of
Incorporation, as amended (the “Certificate of Incorporation”) and our Amended
and Restated By-laws (the “By-laws”) that we have previously filed with the SEC.
See “Where You Can Find More Information.”
General
Our
authorized capital stock consists of: (i) 200,000,000 shares of common
stock, par value $0.01 per share, of which 100,277,960 shares were outstanding
as of March 11, 2010, and (ii) 2,000,000 shares of preferred stock, par value
$0.01 per share, none of which are outstanding.
Common
Stock
Holders
of common stock are entitled to one vote for each share held on all matters
submitted to a vote of stockholders and do not have cumulative voting rights.
Generally, all matters to be voted on by stockholders must be approved by a
majority, or, in the case of the election of directors, by a plurality, of the
votes cast at a meeting at which a quorum is present.
Holders
of our common stock are entitled to receive ratably such dividends, if any, as
may be declared by the Board of Directors out of funds legally available
therefor, subject to any preferential dividend rights of any outstanding
preferred stock. Upon the liquidation, dissolution or winding up of the Company,
the holders of our common stock are entitled to receive ratably the net assets
of the Company available after the payment of all debts and liabilities and
subject to the prior rights of any outstanding preferred stock.
Holders
of our common stock are not entitled to pre-emptive rights or any rights of
conversion. Shares of our common stock are, and the shares being distributed in
this offering will be, when issued, fully paid and nonassessable. The rights,
preferences and privileges of holders of our common stock are subject, and may
be adversely affected by, the rights of holders of shares of any series of
preferred stock which we may designate and issue in the future.
Our
common stock is traded on the NASDAQ Global Market under the symbol NVAX. On
March 11, 2010, the closing price of our common stock as reported on the NASDAQ
Global Market was $2.48 per share.
Our
registrar and transfer agent for all shares of common stock is Computershare
Limited, 250 Royall Street, Canton, MA 02021.
Preferred
Stock
The Board
of Directors may, without further action by the stockholders of the Company,
issue preferred stock in one or more series and fix the rights and preferences
thereof. Our Certificate of Incorporation grants the Board of Directors
authority to issue preferred stock and to determine its rights and preferences
without the need for further stockholder approval to eliminate delays associated
with a stockholder vote on specific issuances.
Examples
of rights and preferences the Board of Directors may fix include dividend
rights, dividend rates, conversion rights, voting rights, pre-emptive rights,
terms of redemption (including sinking fund provisions), redemption prices and
liquidation preferences. The issuance of preferred stock, while providing
desirable flexibility in connection with possible financings, could have the
effect of making it more difficult for a third party to acquire, or of
discouraging a third party from acquiring, a majority of the outstanding voting
stock of the Company. The rights of holders of our common stock, described
above, will be subject to, and may be adversely affected by, the rights of any
preferred stock that we may designate and issue in the future.
The terms
of any particular series of preferred stock will be described in the prospectus
supplement relating to the offering of shares of that particular series of
preferred stock and may include, among other things:
|
·
|
the
title and stated value;
|
|
·
|
the
number of shares authorized;
|
|
·
|
the
liquidation preference per share;
|
|
·
|
the
dividend rate, period and payment date, and method of calculation
(including whether cumulative or non-cumulative), if
any;
|
|
·
|
terms
and amount of any sinking fund, if
applicable;
|
|
·
|
provisions
for redemption or repurchase, if applicable, and any restrictions on the
ability of the Company to exercise such redemption and repurchase
rights;
|
|
·
|
conversion
rights and rates, if applicable, including the conversion price and how
and when it will be calculated and
adjusted;
|
|
·
|
preemptive
rights, if any;
|
|
·
|
restrictions
on sale, transfer and assignment, if
any;
|
|
·
|
the
relative ranking and preferences of the preferred stock;
and
|
|
·
|
any
other specific terms, rights or limitations of, or restrictions on, such
preferred stock.
|
Please
also refer to the description of our Shareholder Rights Plan, below, for a
discussion of the Company’s Series D Junior Participating Preferred
Stock.
Shareholder
Rights Plan
We have
adopted a Shareholder Rights Plan pursuant to which the Board of Directors
declared a dividend distribution of one preferred stock purchase right for each
outstanding share of common stock. Each right, once exercisable, entitles the
holder to purchase from us one one-thousandth (1/1,000th) of a share of
Series D Junior Participating Preferred Stock (the “Series D Preferred
Stock”), at a price of $40.00, subject to certain adjustments.
The
rights, unless earlier redeemed by the Board, become exercisable upon the close
of business on the day which is the earlier of (i) the tenth business day
following a public announcement that a person or group of affiliated or
associated persons (with certain exceptions) has acquired beneficial ownership
of 15% or more of the outstanding voting stock of the Company, and (ii) the
tenth business day after the date of the commencement by any person of a tender
or exchange offer, the consummation of which would result in such person or
group of affiliated or associated persons becoming an “acquiring person” as
defined in the rights plan. The rights expire at the close of business on
August 7, 2012, unless earlier redeemed or exchanged by us as described
below.
Unless
the rights are earlier redeemed, in the event that a person or group becomes an
“acquiring person,” the rights plan provides that proper provisions will be made
so that each holder of record of a right (other than rights beneficially owned
by an acquiring person and certain of its affiliates, associates and
transferees) will thereafter have the right to receive, upon payment of the
exercise price, that number of shares of the Series D Preferred Stock
having a fair market value determined in accordance with the rights plan at the
time of the transaction equal to approximately two times the exercise price
(such value to be determined with reference to the fair market value of our
common stock as provided in the plan).
In
addition, unless the rights are earlier redeemed or exchanged, in the event
that, after the time that a person or group becomes an acquiring person, we were
to be acquired in a merger or other business combination (in which any shares of
common stock are changed into or exchanged for other securities or assets) or
more than 50% of the assets or earning power of the Company and its subsidiaries
(taken as a whole) were to be sold or transferred in one or a series of related
transactions, the rights plan provides that proper provision will be made so
that each holder of record of a right (other than rights beneficially owned by
an acquiring person and certain of its affiliates, associates and transferees)
will have the right to receive, upon payment of the exercise price, that number
of shares of common stock of the acquiring Company having a fair market value at
the time of such transaction determined in accordance with the rights plan equal
to approximately two times the exercise price.
At any
time after any person or group becomes an acquiring person and prior to the
acquisition by such person or group of 50% or more of the outstanding voting
stock, the Board may exchange the rights, in whole or in part, for that number
of shares of the Series D Preferred Stock having a fair market value on the
date such person or group became an acquiring person equal to the excess of
(i) the fair market value of Series D Preferred Stock issuable upon
the exercise of the rights over (ii) the exercise price of the rights, in
each case subject to anti-dilution adjustments.
At any
time prior to the close of business on the tenth business day after there has
been a public announcement that a person has become an acquiring person or such
earlier date as a majority of the Board shall become aware of the existence of
an acquiring person, we may redeem the rights in whole, but not in part, at a
price of $.001 per right. Immediately upon the effective time of such Board
action, the right to exercise the rights will terminate and the only right of
the holders will be to receive the redemption price.
For as
long as the rights are then redeemable, we may, except with respect to the
redemption price, amend the rights in any manner, including extending the time
period in which the rights may be redeemed. At any time when the rights are not
then redeemable, we may amend the rights in any manner that does not materially
adversely affect the interests of holders of the rights as such.
Provisions
of our Certificate of Incorporation and By-laws and Delaware Law
Certain
provisions of our Certificate of Incorporation and By-laws may be deemed to have
an anti-takeover effect and may prevent, delay or defer a tender offer or
takeover attempt that a stockholder may deem in his, her or its best interest.
The existence of these provisions also could limit the price that investors
might be willing to pay for our securities. They include:
Staggered
Board, Removal of Directors and Charter Amendments relating to the
Board
Our
Certificate of Incorporation and By-laws provide for the division of our Board
of Directors into three classes, with no one class having more than one director
more than any other class, serving staggered three year terms. Our By-laws
further provide that directors may be removed only for cause by the affirmative
vote of the holders of 2/3 of the shares of capital stock of the Company issued
and outstanding and entitled to vote. Moreover, our Certificate of Incorporation
provides that any amendments to the charter relating to the number, classes,
election, term, removal, vacancies and related provisions with respect to the
Board may only be made by the affirmative vote of the holders of at least 75% of
the shares of capital stock issued and outstanding and entitled to vote. These
provisions may have the effect of making it more difficult for a third party to
acquire control of Novavax, or of discouraging a third party from acquiring
control of the Company.
Authorized
but Unissued Shares
The
authorized but unissued shares of our common stock and preferred stock are
available for future issuance without stockholder approval, subject to any
limitations imposed by the NASDAQ Stock Market. These additional shares may be
utilized for a variety of corporate purposes. In particular, although our Board
of Directors has no present intention to do so, it could issue shares of
preferred stock that could, depending on the terms of the series, impede the
completion of a merger, tender offer, proxy contest or other takeover attempt.
Our Board may determine that the issuance of such shares of preferred stock is
in the best interest of the Company and our stockholders. Such issuance could
discourage a potential acquiror from making an unsolicited acquisition attempt
through which such acquiror may be able to change the composition of the board,
including a tender offer or other transaction that some, or a majority, of our
stockholders might believe to be in their best interest or in which stockholders
might receive a premium for their stock over the then-current market
price.
Advance
Notice Requirements for Stockholder Proposals and Director
Nominations
Our
By-laws provide that a stockholder seeking to bring business before an annual
meeting of stockholders, or to nominate candidates for election as directors,
must provide timely notice of such stockholder’s intention in writing. To be
timely, a stockholder’s notice must be received not less than 60 nor more than
90 days prior to the meeting at which such candidate or proposal is to be
considered. However, if the Company does not give prior notice or make public
disclosure of the date of the meeting at least 70 days’ prior to the
meeting date, notice is considered timely if it is received no later than the
close of business on the 10th day
following the date on which such notice was given or public disclosure was made
(whichever occurred first). If a stockholder desires to have a proposal included
in the Company’s proxy statement, notice of such proposal must be received not
less than 120 days prior to the first anniversary of the date of the
Company’s notice of the previous year’s annual meeting. These advance notice
provisions may preclude stockholders from bringing matters before a meeting or
from making nominations for directors.
Special
Meetings of Stockholders
Our
By-laws provide that special meetings of stockholders may be called by the Chief
Executive Officer (or, if there is no Chief Executive Officer, the President) or
by the Board of Directors, with no provision for any right of stockholders to
call such meetings. Further, business transacted at any special meeting of
stockholders is limited to matters relating to the purpose or purposes stated in
the notice of meeting.
Section 203
of the General Corporation Law of the State of Delaware
We are
subject to the provisions of Section 203 of the General Corporation Law of
the State of Delaware. Subject to certain exceptions, Section 203 prohibits
a publicly-held Delaware corporation from engaging in a “business combination”
with an “interested stockholder” for a period of three years after the time such
person became an interested stockholder, unless the interested stockholder
attained such status with the approval of our Board of Directors or unless the
business combination is approved in a prescribed manner. A “business
combination” is defined to include a merger, asset sale or other transaction
resulting in a financial benefit to the interested stockholder. Subject to
various exceptions, an “interested stockholder” is a person who, together with
affiliates and associates, owns, or within the past three years did own, 15% or
more of a corporation’s voting stock. This statutory provision could prohibit or
delay the accomplishment of mergers or other takeover or change in control
attempts with respect to us and, accordingly, may discourage attempts to acquire
the Company.
DESCRIPTION
OF OUR WARRANTS
This
description summarizes only the terms of any warrants that we may offer under
this prospectus and related warrant agreements and certificates. You should
refer to the warrant agreement, including the form of warrant certificate
representing the warrants, relating to the specific warrants being offered for
complete terms, which will be described and included in an accompanying
prospectus supplement. Such warrant agreement, together with the warrant
certificate, will be filed with the SEC in connection with the offering of the
specific warrants.
We may
issue warrants for the purchase of common or preferred stock. Warrants may be
issued independently or together with common or preferred stock, and may be
attached to or separate from any offered securities.
We will
evidence each series of warrants by warrant certificates that we will issue
under a separate warrant agreement. We may enter into the warrant agreement with
a warrant agent and, if so, we will indicate the name and address of the warrant
agent in the applicable prospectus supplement relating to the particular series
of warrants.
The
particular terms of any issue of warrants will be described in the prospectus
supplement relating to the series. Those terms may include:
|
·
|
the
title of such warrants;
|
|
·
|
the
aggregate number of such warrants;
|
|
·
|
the
price or prices at which such warrants will be
issued;
|
|
·
|
the
currency or currencies (including composite currencies) in which the price
of such warrants may be payable;
|
|
·
|
the
terms of the securities issuable upon exercise of such warrants and the
procedures and conditions relating to the exercise of such
warrants;
|
|
·
|
the
price at which the securities issuable upon exercise of such warrants may
be acquired;
|
|
·
|
the
dates on which the right to exercise such warrants will commence and
expire;
|
|
·
|
any
provisions for adjustment of the number or amount of securities receivable
upon exercise of the warrants or the exercise price of the
warrants;
|
|
·
|
if
applicable, the minimum or maximum amount of such warrants that may be
exercised at any one time;
|
|
·
|
if
applicable, the designation and terms of the securities with which such
warrants are issued and the number of such warrants issued with each such
security or principal amount of such
security;
|
|
·
|
if
applicable, the date on and after which such warrants and the related
securities will be separately
transferable;
|
|
·
|
information
with respect to book-entry procedures, if any;
and
|
|
·
|
any
other terms of such warrants, including terms, procedures and limitations
relating to the exchange or exercise of such
warrants.
|
The
prospectus supplement relating to any warrants to purchase equity securities may
also include, if applicable, a discussion of certain U.S. federal income tax and
ERISA considerations.
As of
March 11, 2010, the Company has warrants outstanding which are exercisable for
3,343,325 shares of common stock at an exercise price of $3.62 per
share. These warrants expire on July 31, 2013.
Exercise
of Warrants
Each
warrant will entitle its holder to purchase the number of shares of common or
preferred stock at the exercise price set forth in, or calculable as set forth
in, the applicable prospectus supplement. Unless we otherwise specify in the
applicable prospectus supplement, holders of the warrants may exercise the
warrants at any time up to the expiration date set forth in the applicable
prospectus supplement. After the close of business on the expiration date,
unexercised warrants will become void. We will specify the place or places
where, and the manner in which, warrants may be exercised in the applicable
prospectus supplement. We will set forth on the reverse side of the applicable
certificate and in the applicable prospectus supplement the information that the
holder of the warrant will be required to deliver upon exercise.
Upon
receipt of payment and the warrant certificate properly completed and duly
executed, we will, as soon as practicable, forward the purchased securities. If
less than all of the warrants represented by the warrant certificate are
exercised, a new warrant certificate will be issued for the remaining
warrants.
Enforceability
of Rights by Holders of Warrants
Each
warrant agent will act solely as our agent under the applicable warrant
agreement and will not assume any obligation or relationship of agency or trust
with any holder of any warrant. A single bank or trust company may act as
warrant agent for more than one issue of warrants. A warrant agent will have no
duty or responsibility in case of any default by us under the applicable warrant
agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a
warrant may, without the consent of the related warrant agent or the holder of
any other warrant, enforce by appropriate legal action its right to exercise,
and receive the securities purchasable upon exercise of, such holder’s
warrants.
Prior to
the exercise of any warrants to purchase preferred stock or common stock,
holders of the warrants will not have any of the rights of holders of the
preferred stock or common stock purchasable upon exercise, including the right
to vote or to receive any payments of dividends.
DESCRIPTION
OF OUR UNITS
We may
issue units comprised of two or more of the other securities described in this
prospectus in any combination. Each unit will be issued so that the holder of
the unit is also the holder of each security included in the unit. Thus, the
holder of a unit will have the rights and obligations of a holder of each
included security. The units may be issued under unit agreements to be entered
into between us and a bank or trust company, as unit agent, as detailed in the
prospectus supplement relating to units being offered. The prospectus supplement
will describe:
|
·
|
the
designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances the securities
comprising the units may be held or transferred
separately;
|
|
·
|
a
description of the terms of any unit agreement governing the
units;
|
|
·
|
a
description of the provisions for the payment, settlement, transfer or
exchange of the units;
|
|
·
|
a
discussion of material federal income tax considerations, if applicable;
and
|
|
·
|
whether
the units will be issued in fully registered or global
form.
|
The
descriptions of the units in this prospectus and in any prospectus supplement
are summaries of the material provisions of the applicable agreements. These
descriptions do not restate those agreements in their entirety and may not
contain all the information that you may find useful. We urge you to read the
applicable agreements because they, and not the summaries, define your rights as
holders of the units. For more information, please review the form of the
relevant agreements, which will be filed with the SEC promptly after the
offering of units and will be available as described under the heading “Where
You Can Find Additional Information”.
DIVIDEND
POLICY
We have
never paid cash dividends on our common stock. We currently anticipate that we
will retain all of our earnings for use in the development of our business and
do not anticipate paying any cash dividends in the foreseeable
future.
LEGAL
MATTERS
Certain
legal matters with respect to the securities offered hereby have been passed
upon by Ballard Spahr LLP.
EXPERTS
The
financial statements and management’s assessment of the effectiveness of
internal control over financial reporting incorporated by reference in this
prospectus and elsewhere in the registration statement have been so incorporated
by reference in reliance upon the report of Grant Thornton LLP, independent
registered public accountants, upon the authority of said firm as experts in
accounting and auditing in giving said reports.
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 100 F Street, N.E., Washington, D.C. 20549. You can
request copies of these documents, for a copying fee, by writing to the SEC.
Please call the SEC at 1-800-SEC-0330 or visit the SEC’s website for more
information about the operation of the public reference room. Our filings with
the SEC are also available to you over the Internet at the SEC’s web site at
http://www.sec.gov.
The Company’s web site is http://www.novavax.com.
Our
common stock is traded on the NASDAQ Global Market under the symbol NVAX.
Materials we file can also be inspected at the offices of NASDAQ Operations at
1735 K Street, Washington, D.C. 20006.
We have
filed a registration statement on Form S-3 (together with all amendments and
exhibits, which we refer to as the registration statement) with the SEC under
the Securities Act with respect to the securities offered by this prospectus.
This prospectus, which constitutes a part of the registration statement, does
not contain all the information in the registration statement. For further
information about us and our securities, see the registration statement and its
exhibits. Statements made in this prospectus as to the content of any contract,
agreement or other document are not necessarily complete. With respect to each
such contract, agreement or other document filed as an exhibit to the
registration statement, reference is made to the exhibit for a more complete
description of the matter involved, and each such statement shall be deemed
qualified in its entirety by such reference.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The SEC
allows us to “incorporate by reference” in this prospectus the information in
other documents that we file with it, which means that we can disclose important
information to you by referring you to those documents containing such
information. This prospectus is part of a registration statement we filed with
the SEC. You should rely on the information incorporated by reference in this
prospectus and the registration statement. The information incorporated by
reference is considered to be part of this prospectus and information we file
later with the SEC will automatically update and supersede this information and
information contained in documents filed earlier with the Commission. We
incorporate by reference the documents listed below and any future filings made
with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act
prior to the termination of the offering; provided, that we are not
incorporating by reference any documents or information deemed to have been
furnished and not filed in accordance with SEC rules. The documents we are
incorporating by reference are:
|
·
|
Annual
Report on Form 10-K for the year ended December 31, 2009, filed on
March 16, 2010;
|
|
·
|
Current
Reports on Form 8-K filed on January 12, 2010, January 13, 2010, February
8, 2010, February 9, 2010, February 18, 2010 and March 17, 2010;
and
|
|
·
|
The
description of our common stock contained in the Registration Statement on
Form 10 filed with the SEC on September 14,
1995.
|
We will
furnish to you, on written or oral request, a copy of any or all of the
documents that have been incorporated by reference, including exhibits to these
documents. You may request a copy of these filings at no cost by
writing or telephoning Investor Relations at the following address and telephone
number:
Novavax,
Inc.
9920
Belward Campus Drive
Rockville,
MD 20850
(240)
268−2000
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted.
Subject
to Completion, Dated March 25, 2010
PROSPECTUS
25,000,000
SHARES
COMMON STOCK
You
should carefully read this prospectus before you invest. It contains information
you should consider before making your investment decision.
This
prospectus relates to the issuance and sale of up to 25,000,000 shares of our
common stock through our sales agent, McNicoll, Lewis & Vlak LLC (“MLV”).
These sales, if any, will be made pursuant to the terms of an At Market Issuance
Sales Agreement entered into between us and our sales agent on March 15, 2010, a
copy of which was filed with the Securities and Exchange Commission as an
exhibit to our Annual Report on Form 10-K for the year ended December 31, 2009,
and is incorporated herein by reference. This prospectus relates to the sale of
up to $50,000,000 in gross proceeds of our common stock pursuant to the sales
agreements. Our board has authorized 25,000,000 shares of common
stock to be sold pursuant to this prospectus.
Our
common stock is quoted on the NASDAQ Global Market under the symbol “NVAX.” On
March 11, 2010, the closing price of our common stock as reported on NASDAQ was
$2.48 per share. Sales of shares of our common stock under this prospectus, if
any, may be made in privately negotiated transactions and/or any other method
permitted by law, including sales deemed to be an “at the market” offering as
defined in Rule 415 under the Securities Act of 1933, as amended, which
includes sales made directly on NASDAQ Global Market, the existing trading
market for our common stock, or sales made to or through a market maker other
than on an exchange. The sales agent will make all sales using commercially
reasonable efforts consistent with its normal trading and sales practices, on
mutually agreeable terms between the sales agent and us.
Unless we
and our sales agent otherwise agree, we will pay our sales agent a commission
equal to 2% of the gross proceeds of the sales price per share. Any
other fee arrangement or commission amount to be received by the sales agent
will be disclosed in a separate prospectus supplement for such shares. The net
proceeds to us that we receive from sales of our common stock will depend on the
number of shares actually sold and the offering price for such shares. Based on
the closing price of our common stock on March 11, 2010, because we are limited
to the sale of common stock with gross proceeds aggregating $50,000,000, the
maximum number of shares we could sell is 20,161,290. If 20,161,290 shares of
common stock were sold at the March 11, 2010 closing sales price, we would
receive $50,000,000 in gross proceeds, or $49,000,000 in aggregate net proceeds
assuming the sales agent fee is paid as described above. The actual proceeds to
us will vary.
In
connection with the sale of common stock on our behalf, the sales
agent will be deemed an “underwriter” within the meaning of the Securities
Act of 1933, as amended, and the compensation of the sales agent will be
deemed to be underwriting commissions or discounts. We have agreed to provide
indemnification and contribution to the sales agent against certain liabilities,
including liabilities under the Securities Act of 1933, as
amended.
Investing in our common stock
involves a high degree of risk. Risks associated with an investment in our
common stock are described in the section titled “Risk Factors” beginning on
page A-8 of this prospectus. You should carefully consider these risk factors
before making an investment decision.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of
these securities or determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
McNicoll,
Lewis & Vlak LLC
The date
of the Prospectus is _____ __, 2010.
TABLE
OF CONTENTS
SPECIAL
NOTE ON FORWARD-LOOKING STATEMENTS
|
A-ii
|
PROSPECTUS
SUMMARY
|
A-2
|
THE
OFFERING
|
A-6
|
RISK
FACTORS
|
A-7
|
USE
OF PROCEEDS
|
A-27
|
DILUTION
|
A-27
|
PLAN
OF DISTRIBUTION
|
A-28
|
LEGAL
MATTERS
|
A-29
|
EXPERTS
|
A-29
|
LIMITATION
OF LIABILITY AND INDEMNIFICATION
|
A-29
|
WHERE
YOU CAN FIND MORE INFORMATION
|
A-29
|
INCORPORATION
BY REFERENCE
|
A-30
|
You
should rely only on the information contained in this prospectus and the
documents we incorporate by reference in this prospectus. We have not authorized
anyone to provide you with information different from that contained or
incorporated by reference in this prospectus. If anyone provides you with
different or inconsistent information, you should not rely on it. You should
assume that the information contained in this prospectus, as well as the
information that we have filed with the Securities and Exchange Commission, or
the SEC, and incorporated by reference herein, is accurate only as of the date
of the applicable document. This prospectus does not constitute an offer or
solicitation by anyone in any jurisdiction in which an offer or solicitation is
not authorized or in which the person making an offer or solicitation is not
qualified to do so, or to anyone to whom it is unlawful to make an offer or
solicitation.
The information contained in this
prospectus is correct only as of the date on the cover, regardless of the date
this prospectus was delivered to you or the date on which you acquired any of
the shares.
SPECIAL
NOTE ON FORWARD-LOOKING STATEMENTS
This
prospectus and the documents we have filed with the Securities and Exchange
Commission, or SEC, that are incorporated herein by reference and that are
referenced under the section entitled “Where You Can Find More Information”,
contain “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements include,
but are not limited to, statements relating to future financial or business
performance, conditions or strategies and other financial and business matters,
including expectations regarding operating expenses, use of cash, and clinical
developments and anticipated milestones, including a BARDA contract, Phase 3
studies and seeking approval in Mexico, and include words such as “expect(s)”,
“intends”, “plans”, “seeks”, “estimates”, “could”, “should”, “feel(s)”,
“believe(s)”, “will”, “would”, “may”, “can”, “anticipate(s)”, “potential”, and
similar expressions or the negative of these terms, are based upon management’s
current expectations and beliefs. Such forward-looking statements are
not guarantees of future performance, involve known and unknown risks,
uncertainties and other factors which may cause the actual results, performance
or achievements of the Company, or industry results, to be materially different
from those expressed or implied by such forward-looking statements.
Factors
that may cause actual results to differ materially from the results discussed in
the forward-looking statements or historical experience include, among other
things, the following: our ability to progress any product candidates
into pre-clinical or clinical trials; the scope, initiation, rate and progress
of our pre-clinical studies and clinical trials and other research and
development activities; clinical trial results; even if the data from
pre-clinical studies or clinical trials is positive, the product may not prove
to be safe and efficacious; regulatory approval is needed before any vaccines
can be sold in or outside the United States and, to date, no governmental
authority has approved any of our vaccine candidates for sale; influenza is
seasonal in nature, and if approval or commercial launch after approval is not
timely in relation to the influenza season, we may not be able to manufacture or
sell our influenza vaccines on terms favorable to us until the next influenza
season, if at all; we have not manufactured any of our vaccine candidates at a
commercial level; we utilize a unique
manufacturing process and the scale-up of that process may prove difficult and
costly; our dependence on third parties to manufacture and distribute our
vaccines; risks associated with conducting business outside of the United
States; our ability to enter into future collaborations with industry partners
and the terms, timing and success of any such collaboration; our ability to
obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity or debt financing or
otherwise; the inability to win any government grants, including BARDA in a
timely manner or at all and other factors referenced herein.
You
should also consider carefully the statements set forth in the section entitled
“Risk Factors” and other sections of this prospectus and in the other documents
we have filed with the SEC and that are incorporated herein by reference, which
address these and additional factors that could cause results or events to
differ from those set forth in the forward-looking statements. All subsequent
written and oral forward-looking statements attributable to us or to persons
acting on our behalf are expressly qualified in their entirety by the applicable
cautionary statements. Unless required by law, we have no plans to update these
forward-looking statements, whether as a result of new information, future
events, or otherwise.
PROSPECTUS
SUMMARY
This
summary only highlights the more detailed information appearing elsewhere in
this prospectus and the documents incorporated by reference herein and therein.
It may not contain all of the information that may be important to you. To fully
understand the investment you are contemplating, you should read carefully this
entire prospectus and the detailed information incorporated herein by reference
before you decide to make an investment. You should pay special attention to the
“Risk Factors” section of this prospectus beginning on page A-8 to determine
whether an investment in our common stock is appropriate for you. Unless the
context otherwise requires, the terms “Novavax,” “we,” “us,” “the company” and
“our” refer to Novavax , Inc., a Delaware corporation, together with its
subsidiary.
NOVAVAX,
INC.
Our
Business
Novavax,
Inc. (“Novavax,” the “Company,” “we” or “us”) is a biopharmaceutical company
focused on developing novel, highly potent recombinant vaccines. Our goal is to
become a profitable vaccine company that is aggressively driving towards
development, licensure and commercialization of important vaccine
candidates.
Our
technology platform is based on proprietary virus-like particles (VLPs). Our
VLPs are genetically engineered three-dimensional nanostructures, which
incorporate immunologically important recombinant proteins. Recombinant
protein-based vaccines are widely used and accepted. Examples of vaccines
currently available that use recombinant protein particle technology include
Recombivax® HB (Merck) and Engerix® (GlaxoSmithKline), which protect against
Hepatitis B, and Gardasil® (Merck) and Cervarix® (GlaxoSmithKline), which
protect against human papilloma virus. Our product pipeline targets several
infectious diseases. Currently, we have vaccine product candidates to target
pandemic influenza (both H1N1 and H5N1 strains), seasonal influenza, Respiratory
Syncytial Virus (RSV) and Varicella Zoster Virus (VZV).
Our
proprietary production technology uses insect cells rather than chicken eggs or
mammalian cells. This platform offers several potential significant advantages
over traditional vaccine production, including: (1) higher yields than
traditional mammalian or egg-based system, (2) faster facility commissioning
time, (3) significantly lower capital expenditures on infrastructure, (4)
competitive cost of goods, (5) shorter lead time to produce vaccine than
egg-based technology, and (6) a scalable production process that can respond
rapidly to pandemic outbreaks.
Our
production process involves the use of genetic information and no viral seed is
required. This shortens the time of creating a new vaccine by several weeks
compared to the egg-based process. Furthermore, the production process for
manufacturing our VLP vaccines is also unique because the equipment we use in
the cell culture process is largely portable and disposable. A facility to
produce VLP-based vaccines can be constructed and validated in significantly
less time as compared to traditional egg-based facilities.
We
produce VLPs using a baculovirus expression system in insect cells with
disposable low cost equipment that can be readily dispersed both nationally and
internationally. By not requiring significant production batch sizes, production
capacity can be employed quickly; estimated to be built and validated within
twelve to eighteen months compared to the current approved manufacturing
technology that can take four years or more to deploy.
We have a
significant amount of experience in developing recombinant VLP influenza
vaccines. To date, among other things, we have:
|
·
|
conducted
five human clinical studies for our seasonal and pandemic influenza
vaccine candidates;
|
|
·
|
administered
our seasonal and pandemic influenza VLPs (seven distinct strains) to over
4,200 subjects demonstrating vaccine safety and
immunogenicity;
|
|
·
|
completed
four animal toxicology studies without any safety
issues;
|
|
·
|
conducted
multiple ferret studies demonstrating efficacy of VLP influenza vaccine
candidates; and
|
|
·
|
conducted
vaccine production under current good manufacturing practices (cGMP) and
manufactured more than 35 batches of VLP vaccine with over a dozen
different influenza strains.
|
We
believe our influenza VLP vaccines have potential immunological advantages over
currently available products. Our influenza VLPs contain three of the major
structural influenza virus proteins, which we believe are important to combat
influenza: hemagglutinin (HA) and neuraminidase (NA), both of which stimulate
the body to produce antibodies that neutralize the influenza virus and prevent
spread through the cells in the respiratory tract, and matrix 1 (M1), which
stimulates cytotoxic T lymphocytes to kill cells that may already be infected.
Further, our VLPs are not made from a live virus and have no genetic nucleic
material in their inner core, which renders them incapable of replicating and
causing disease.
Pandemic
Influenza
In May
2009, we announced that we had produced a first batch of non-cGMP influenza A
(H1N1) VLP vaccine candidate three weeks after the Center for Disease Control
and Protection (CDC) announced the genetic sequence of the novel H1N1 virus (the
H1N1 virus is commonly referred to as the “swine flu” in the media). The
purified H1N1 VLP vaccine candidate was sent to scientists at the CDC and an
agreement was made with the Division of Microbiology and Infectious Diseases
(DMID) of the National Institute of Allergy and Infectious Diseases and the
National Institutes of Health for further studies. To further demonstrate the
capability of recombinant VLP technology, we manufactured an H1N1 VLP vaccine
candidate under cGMP at our vaccine manufacturing facility in Rockville, MD
within eleven weeks after receiving the gene sequence from the CDC.
In
October 2009, we initiated a two-stage clinical trial of our H1N1 vaccine
candidate in Mexico in collaboration with Laboratorio Avi-Mex S.A. de C.V.
(Avimex). The first stage of the study evaluated the vaccine’s safety,
immunogenicity and efficacy in 1,000 subjects, including 750 vaccine recipients
and 250 placebo recipients. In December 2009, we reported positive results from
the first stage of the study. Based on these results, the Independent Data and
Safety Monitoring Board recommended that we proceed with the second stage of the
study to evaluate the safety of the vaccine in a larger cohort of 3,000 subjects
(2,000 vaccine and 1,000 placebo recipients). This study has been fully
enrolled. With the positive data reported in December 2009, we have filed for
regulatory approval of our 2009 H1N1 vaccine candidate in Mexico. These data are
also expected to support our pandemic and seasonal influenza VLP vaccines in
other countries. We believe this effort in Mexico represents a unique
opportunity for Novavax to accelerate the development of our H1N1 vaccine
candidate.
We have
also made significant progress in the development of our vaccine that targets
the H5N1 avian influenza with pandemic potential. In 2007, we released results
from an important pre-clinical study in which ferrets that received our pandemic
vaccine candidate were protected from a lethal challenge of the H5N1 virus.
After filing an Investigational New Drug application (IND), we initiated a Phase
I/IIa human clinical trial. We released interim human data from the first
portion of this clinical trial in December 2007. These interim results
demonstrated that our pandemic influenza vaccine can generate a protective
immune response. We conducted the second portion of the Phase I/IIa trial in
2008 to gather additional subject immunogenicity and safety data and determine a
final dose through the completion of this clinical trial. In August 2008, we
reported favorable results from this clinical trial, which demonstrated strong
neutralizing antibody titers across all three doses tested. A final clinical
study report has been completed and the vaccine was well tolerated at all
dosages as compared with placebo. No serious adverse events were reported. In
February 2009, we announced that the vaccine induced robust hemagglutination
inhibition (HAI) responses, which have been shown to be important for protection
against influenza disease.
Seasonal
Influenza
We have
also progressed the development of our VLP trivalent vaccine that targets the
seasonal influenza virus. In 2008, we announced positive results from an
immunogenicity study in ferrets inoculated with our seasonal influenza vaccine
candidate. Subsequently, we conducted a Phase IIa clinical trial to evaluate the
safety and immunogenicity of different doses of our seasonal influenza vaccine.
In December 2008, we announced favorable safety and immunogenicity results from
this Phase IIa seasonal study in healthy adults (aged between 18 and 49 years).
A final clinical study report was completed and no vaccine-related serious
adverse events were reported. In May 2009, we enrolled subjects in a second
Phase II study in healthy adults. In September 2009, we announced favorable
results from this Phase II study in healthy adults that supports a new Phase II
dose range study in elderly patients (60 years of age or older), head-to-head
with a marketed vaccine that we commenced in November 2009. In September 2009,
we responded to the United States government (HHS BARDA) request for proposal
(RFP) for a potential contract award for the advanced development of recombinant
influenza vaccines. If we receive the award it could provide significant funding
for the continued ongoing clinical development of our seasonal and pandemic
influenza vaccines. Based on the results of the Phase II trial in elderly
subjects and our ability to potentially receive the HHS BARDA contract and
receive it in a timely manner, we plan to begin Phase III studies and seek to
file United States registration of this vaccine candidate.
RSV and
VZV
We have
also developed vaccine candidates for both RSV and VZV, both of which are
currently being evaluated in pre-clinical studies. To date, our RSV vaccine
candidate has demonstrated positive results in two separate studies with mice.
These studies have been confirmed in two more studies in cotton rats, which are
generally accepted as the best model to evaluate the safety of candidate RSV
vaccines. In February 2009, we announced favorable results from an RSV
pre-clinical study performed in mice against the viral fusion (F) protein,
which fuses with cells in the respiratory tract and causes illness. The vaccine
induced neutralizing antibodies against the viral fusion protein and also
protected against RSV infection. In January 2010, we announced positive
pre-clinical results with a recombinant RSV fusion (F) particle vaccine in
cotton rats. The RSV F vaccine candidate completely protected the vaccinated
animals and there was no evidence of enhanced disease in the lungs of vaccinated
animals following challenge with live RSV. We also announced the successful
scale-up and cGMP manufacturing of vaccine
and the initiation of a rabbit toxicology study in preparation for submission of
an RSV IND to the United States Food and Drug Administration (FDA). We plan to
file an IND and launch a Phase I clinical trial in 2010.
A
multi-protein VZV particle vaccine candidate is currently in development. The
VZV vaccine was shown in mice to induce antibody and T-cell responses.
Formulation of the VZV vaccine candidate is being finalized and tested in
preparation for human trials.
Corporate
Information
Novavax
was incorporated in 1987 under the laws of the State of Delaware. Our
principal executive offices are located at 9920 Belward Campus Drive, Rockville,
Maryland, 20850. Our telephone number is (240) 268−2000 and our
website address is www.novavax.com. The contents of our website are
not part of this prospectus. The information on or accessible through
our website is not incorporated by reference into this filing.
THE
OFFERING
|
|
|
Issuer
|
|
Novavax,
Inc.
|
|
|
|
Common
Stock offered by us pursuant to this prospectus
|
|
Up
to 25,000,000 shares
|
|
|
|
Common
Stock to be outstanding after this offering if all shares are
sold
|
|
Up
to 125,277,960 1
shares
|
|
|
|
Maximum
Gross Proceeds
|
|
$50,000,000
|
|
|
|
Manner
of Offering
|
|
Sales
of shares of our common stock under this prospectus, if any, may be made
in privately negotiated transactions and/or any other method permitted by
law, including sales deemed to be an “at the market” offering as defined
in Rule 415 under the Securities Act of 1933, as amended, which
includes sales made directly on the NASDAQ Global Market, the existing
trading market for our common stock, or sales made to or through a market
maker other than on an exchange. The sales agent will make all sales using
commercially reasonable efforts consistent with its normal trading and
sales practices, on mutually agreeable terms between the sales agent and
us. See “Plan of Distribution.”
|
|
|
|
Sales
agent
|
|
McNicoll,
Lewis & Vlak LLC
|
|
|
|
NASDAQ
Symbol
|
|
NVAX
|
|
|
|
Use
of Proceeds
|
|
The
net proceeds of this offering will be added to our general funds and used
for pre-clinical studies and clinical trials of our VLP-based vaccines,
internal research and development programs, working capital, capital
expenditures and other general corporate purposes as further described in
this prospectus under the heading “Use of
Proceeds.”
|
1
|
The
number of shares of common stock to be outstanding after this offering is
based on 100,277,960 shares outstanding as of March 11,
2010. The number of shares of our common stock to be
outstanding after the offering does not take into
account:
|
|
·
|
5,900,678 shares
of our common stock reserved for issuance upon the exercise of outstanding
stock options at a weighted average exercise price of $2.95 per
share;
|
|
·
|
2,791,396
shares of our common stock reserved for future awards under our 2005 Stock
Incentive Plan; and
|
|
·
|
3,343,325
shares of our common stock reserved for issuance upon the exercise of
outstanding warrants.
|
RISK
FACTORS
An
investment in our securities involves a high degree of risk. Before purchasing
our common stock, you should carefully consider the following risk factors in
evaluating our business. There are a number of risk factors that could cause our
actual results to differ materially from those that are indicated by
forward-looking statements. Some of the risks described relate principally to
our business and the industry in which we operate. Others relate principally to
the securities market and ownership of our common stock. The risks and
uncertainties described below are not the only ones facing us. Additional risks
and uncertainties that we are unaware of, or that we currently deem immaterial,
also may become important factors that affect us. Additional risks and
uncertainties that are not yet identified or that we currently deem immaterial
may materially harm our business, operating results and financial condition and
could result in a complete loss of your investment. If any of the following
risks occur, our business, financial condition or results of operations could be
materially and adversely affected.
RISKS
RELATED TO OUR BUSINESS
We have a history of losses and our
future profitability is uncertain.
Our
expenses have exceeded our revenue since our formation in 1987, and our
accumulated deficit at December 31, 2009 was $274.2 million. Our revenue for the
last three fiscal years from continuing operations was $0.3 million in 2009,
$1.1 million in 2008 and $1.5 million in 2007. We have recorded limited revenue
from research contracts, licenses and agreements to provide vaccine candidates,
services and technologies. We cannot be certain that we will be successful in
entering into strategic alliances or collaborative arrangements with other
companies that will result in significant revenue to offset our expenses. Our
net losses for the last three fiscal years were $38.4 million in 2009,
$36.0 million in 2008 and $34.8 million in 2007, including
discontinued operations.
Our
recent historical losses have predominantly resulted from research and
development expenses for our vaccine product candidates, sales and marketing
expenses, manufacturing-related expenses, costs related to protection of our
intellectual property and for other general operating expenses. Our expenses
have exceeded our revenue since inception. We believe our expenses will continue
to increase, as a result of higher research and development efforts to support
the development of our vaccines, particularly our pandemic and seasonal
influenza vaccines.
We expect
to continue to incur significant operating expenses and anticipate that our
expenses and losses will increase in the foreseeable future as we seek
to:
|
·
|
initiate
Phase III and complete Phase II clinical trials for our seasonal influenza
vaccine;
|
|
·
|
conduct
additional pre-clinical studies for VZV and RSV product candidates and
begin clinical trials for RSV;
|
|
·
|
comply
with the FDA’s manufacturing facility
requirements;
|
|
·
|
scale-up
our manufacturing process for commercial scale and cost efficiency;
and
|
|
·
|
maintain,
expand and protect our intellectual property
portfolio.
|
As a
result, we expect our cumulative operating losses to increase until such time,
if ever, that product sales, licensing fees, royalties, milestones, contract
research and other sources generate sufficient revenue to fund our continuing
operations. We cannot predict when, if ever, we might achieve profitability and
cannot be certain that we will be able to sustain profitability, if
achieved.
We
have limited financial resources and we are not certain that we will be able to
maintain our current level of operations or be able to fund the further
development of our product candidates.
We do not
expect to generate revenue from product sales, licensing fees, royalties,
milestones, contract research or other sources in an amount sufficient to fund
our operations for the foreseeable future, and we will therefore use our cash
resources and expect to require additional funds to maintain our operations,
continue our research and development programs, commence future pre-clinical
studies and clinical trials, seek regulatory approvals and manufacture and
market our products. We will seek such additional funds through public or
private equity or debt financings, collaborative licensing and development
arrangements, government grants and other sources. While we continue to apply
for grants from academic institutions, non-profits and governmental entities,
there are no assurances that we would be successful. We cannot be certain that
adequate additional funding will be available to us on acceptable terms, if at
all. If we cannot raise the additional funds required for our anticipated
operations, we may be required to delay significantly, reduce the scope of or
eliminate one or more of our research or development programs, downsize our
general and administrative infrastructure, or seek alternative measures to avoid
insolvency, including arrangements with collaborative partners or others that
may require us to relinquish rights to certain of our technologies, product
candidates or products. If we raise additional funds through future offerings of
shares of our common stock or other securities, such offerings would cause
dilution of your percentage ownership in the Company which could be substantial.
Future offerings also could have a material and adverse effect on the price of
our common stock.
The
current capital and credit market conditions may adversely affect our access to
capital, cost of capital, and ability to execute our business plan as
scheduled.
Access to
capital markets is critical to our ability to operate. Traditionally,
biopharmaceutical companies have funded their research and development
expenditures through raising capital in the equity markets. Declines and
uncertainties in these markets in the past have severely restricted raising new
capital and have affected companies’ ability to continue to expand or fund
existing research and development efforts. We require significant capital for
research and development for our product candidates and clinical trials. The
general economic and capital market conditions, both in the United States and
worldwide, have been extremely volatile over the past eighteen months and have
adversely affected our access to capital and increased the cost of capital, and
any recovery will likely be very slow. There is no certainty that the capital
and credit markets will recover to the point where we could raise additional
capital on terms similar to the terms that companies raised capital prior to the
deterioration. If these economic conditions continue or become worse, our future
cost of equity or debt capital and access to the capital markets could be
adversely affected. In addition, our inability to access the capital markets on
favorable terms due to our low stock price, or upon a potential delisting from
the NASDAQ Global Market if we fail to satisfy a listing requirement, could
affect our ability to execute our business plan as scheduled. Moreover, we rely
and intend to rely on third-parties, including our clinical research
organizations, third-party manufacturers and certain other important vendors and
consultants. As a result of the global economic situation, there may be a
disruption or delay in the performance of our third-party contractors and
suppliers. If such third-parties are unable to adequately satisfy their
contractual commitments to us in a timely manner, our business could be
adversely affected.
We
may not be able to win government, academic institution or non-profit
grants.
From time
to time, we may apply for grants from academic institutions, government agencies
and non-profit entities and, most recently, we responded to the United States
Government RFP solicitation number HHS BARDA-09-32 for a contract award for the
advanced development of recombinant influenza vaccines. Such grants or contracts
can be highly attractive because they provide capital to fund the ongoing
development of our technologies and product candidates without diluting our
stockholders. However, there is often significant competition for these grants.
Grantors may have requirements to apply for or to otherwise be eligible to
receive certain grants that our competitors may be able to satisfy that we
cannot. In addition, grantors may make arbitrary decisions as to whether to make
grants, to whom the grants will be awarded and the size of the grants to each
awardee. Even if we are able to satisfy the award requirements, there is no
guarantee that we will be a successful awardee. Therefore, we may not be able to
win any grants, including BARDA in a timely manner, if at all, which could delay
the start of our Phase III program in seasonal influenza.
A
portion of our investments are auction rate securities which present potential
liquidity concerns.
As of
December 31, 2009, we had $5.1 million invested in three auction rate
securities, which were classified as short-term investments available-for-sale
and carried at their estimated fair value of $4.2 million. Auction rate
securities are long-term debt instruments that provide liquidity through a
competitive bidding process known as a “Dutch Auction” that resets the
applicable interest rates at pre-determined calendar intervals. Although two
auction rate securities were redeemed during the year ended December 31, 2009,
as a result of the issues that presently exist in the credit markets, we may be
unable to liquidate some or all of our remaining auction rate securities when we
are in need of the cash to fund operations at prices that are acceptable to us.
Even if we are able to liquidate the investments, the sales may be at a loss. In
addition, given the complexity of auction rate securities and their valuations,
our estimates of their fair value may differ from the actual amount we would be
able to collect in the ultimate sale. It is uncertain as to when the liquidity
issues relating to these investments will improve.
Our
collaborations with regional partners, such as Cadila and Avimex, expose us to
additional risks associated with doing business outside the United States, and
any adverse event could have a material negative impact on our
operations.
We have
formed a joint venture with Cadila in India and have entered into other
agreements and arrangements with companies in other countries. We plan to
continue to enter into collaborations or partnerships with companies, non-profit
organizations and local governments in other parts of the world. Risks of
conducting business outside the United States include:
|
·
|
multiple
regulatory requirements could affect the ability to develop, manufacture
and sell products in such local
markets;
|
|
·
|
compliance
with anti-bribery laws such as the United States Foreign Corrupt Practices
Act and similar anti-bribery laws in other
jurisdictions;
|
|
·
|
trade
protections measures and import and export licensing
requirements;
|
|
·
|
different
labor regulations;
|
|
·
|
changes
in environmental, health and safety
laws;
|
|
·
|
potentially
negative consequences from changes in or interpretations of tax
laws;
|
|
·
|
political
instability and actual or anticipated military or potential
conflicts;
|
|
·
|
economic
instability, inflation, recession and interest rate
fluctuations;
|
|
·
|
minimal
or diminished protection of intellectual property in some countries;
and
|
|
·
|
possible
nationalization and expropriation.
|
These
risks, individually or in the aggregate, could have a material adverse effect on
our business, financial conditions, results of operations and cash
flows.
Our
strategy to enter into regional relationships may hinder our ability to engage
in a larger transaction.
We have
entered into regional collaborations to develop our product candidates in
certain parts of the world. Our relationships with Cadila and Avimex are
examples of this strategy. We expect that many of these relationships will
involve the licensing of our technology to our partner or entering into a
distribution agreement, frequently on an exclusive basis. Generally, these
exclusive agreements are restricted to certain territories. Because we have
entered into exclusive license and distribution agreements, larger companies may
not be interested, or able, to enter into collaborations with us on a worldwide
scale. Also, these regional relationships may make us an unattractive target for
an acquisition.
We
are a biopharmaceutical company and face significant risk in developing,
manufacturing and commercializing our products.
We focus
our research and development activities on vaccines, an area in which we have
particular strengths and a technology that appears promising. The outcome of any
research and development program is highly uncertain. Only a small fraction of
biopharmaceutical development programs ultimately result in commercial products
or even product candidates and a number of events could delay our development
efforts and negatively impact our ability to obtain regulatory approval for, and
to manufacture, market and sell, a product candidate. Product candidates that
initially appear promising often fail to yield successful products. In many
cases, pre-clinical or clinical studies will show that a product candidate is
not efficacious or that it raises safety concerns or has other side effects that
outweigh its intended benefit. Success in pre-clinical or early clinical trials
may not translate into success in large-scale clinical trials. Further, success
in clinical trials will likely lead to increased investment, accelerating
cumulative losses, to bring such products to market. Even if clinical trial
results are positive, we may face challenges when scaling-up the manufacturing
process to commercial levels. Even after a product is approved and launched,
general usage or post-marketing studies may identify safety or other previously
unknown problems with the product, which may result in regulatory approvals
being suspended, limited to narrow indications or revoked, which may otherwise
prevent successful commercialization. Intense competition in the vaccine
industry could also limit the successful commercialization of our
products.
Many
of our competitors have significantly greater resources and experience, which
may negatively impact our commercial opportunities and those of our current and
future licensees.
The
biotechnology and pharmaceutical industries are subject to intense competition
and rapid and significant technological change. We have many potential
competitors, including major drug and chemical companies, specialized
biotechnology firms, academic institutions, government agencies and private and
public research institutions. Many of our competitors have significantly greater
financial and technical resources, experience and expertise in:
|
·
|
research
and development;
|
|
·
|
designing
and implementing clinical trials;
|
|
·
|
regulatory
processes and approvals;
|
|
·
|
production
and manufacturing; and
|
|
·
|
sales
and marketing of approved products.
|
Principal
competitive factors in our industry include:
|
·
|
the
quality and breadth of an organization’s
technology;
|
|
·
|
management
of the organization and the execution of the organization’s
strategy;
|
|
·
|
the
skill and experience of an organization’s employees and its ability to
recruit and retain skilled and experienced
employees;
|
|
·
|
an
organization’s intellectual property
portfolio;
|
|
·
|
the
range of capabilities, from target identification and validation to drug
discovery and development to manufacturing and marketing;
and
|
|
·
|
the
availability of substantial capital resources to fund discovery,
development and commercialization
activities.
|
Large and
established companies such as Merck & Co., Inc., GlaxoSmithKline PLC,
Novartis, Inc., sanofi pasteur, Inc. and MedImmune Inc. (a subsidiary of
Astra-Zeneca, Inc.), among others, compete in the vaccine market. In particular,
these companies have greater experience and expertise in securing government
contracts and grants to support their research and development efforts,
conducting testing and clinical trials, obtaining regulatory approvals to market
products, and manufacturing such products on a broad scale and marketing
approved products.
There are
many seasonal influenza vaccines currently approved and marketed. Competition in
the sale of these seasonal influenza vaccines is intense. Therefore, newly
developed and approved products must be differentiated from existing vaccines in
order to have commercial success. In order to show differentiation in the
seasonal influenza space, a product must be more efficacious, particularly in
the elderly population, and/or be less expensive and quicker to manufacture.
Many of our competitors are working on new products and new generations of
current products, often by adding an adjuvant that is used to increase the
efficacy of the current product, each of which is intended to be more
efficacious than products currently being marketed. Our seasonal influenza
product may not prove to be more efficacious than current products or products
under development by our competitors. Further, our manufacturing system may not
provide enough savings of time or money to provide the required differentiation
for commercial success.
Smaller
or early-stage companies and research institutions may also prove to be
significant competitors, particularly through collaborative arrangements with
large and established pharmaceutical or other companies. As these companies
develop their technologies, they may develop proprietary positions, which may
prevent or limit our product development and commercialization efforts. We will
also face competition from these parties in recruiting and retaining qualified
scientific and management personnel, establishing clinical trial sites and
subject registration for clinical trials, and in acquiring and in-licensing
technologies and products complementary to our programs or potentially
advantageous to our business. If any of our competitors succeed in obtaining
approval from the FDA or other regulatory authorities for their products sooner
than we do or for products that are more effective or less costly than ours, our
commercial opportunity could be significantly reduced.
In order
to effectively compete, we will have to make substantial investments in
development, testing, manufacturing and sales and marketing or partner with one
or more established companies. There is no assurance that we will be successful
in gaining significant market share for any product or product candidate. Our
technologies and products also may be rendered obsolete or non-competitive as a
result of products introduced by our competitors to the marketplace more rapidly
and at a lower cost.
If
we lose or are unable to attract key management or other personnel, we may
experience delays in product development.
We depend
on our senior executive officers, as well as key scientific and other personnel.
The loss of these individuals could harm our business and significantly delay or
prevent the achievement of research, development or business objectives.
Employment with our Chief Medical Officer and Vice President of Manufacturing
ended in November 2009 and January 2010, respectively. While we are searching
for replacements, we may not be able to attract qualified individuals on terms
acceptable to us. We appointed John J. Trizzino as Senior Vice President,
International and Government Alliances, in July 2009. Our Chief Financial
Officer, Frederick Driscoll, assumed this responsibility in August 2009. In
February 2010 Stanley Erck was appointed Executive Chairman of the Board. This
lack of management continuity, the resulting lack of long-term history with our
Company and the learning curve that executives experience when they join our
management team, could result in operational and administrative inefficiencies
and added costs. If we were to experience additional turnover at the executive
level, these risks would be exacerbated.
We may
not be able to attract qualified individuals for other key management or other
personnel positions on terms acceptable to us. Competition for qualified
employees is intense among pharmaceutical and biotechnology companies, and the
loss of qualified employees, or an inability to attract, retain and motivate
additional highly skilled employees required for the expansion of our
activities, could hinder our ability to complete human studies successfully and
develop marketable products.
We also
rely from time-to-time on outside advisors who assist us in formulating our
research and development and clinical strategy. We may not be able to attract
and retain these individuals on acceptable terms, which could have a material
adverse effect on our business, financial condition and results of
operations.
We
do not currently have a majority of independent directors and are, therefore,
not in compliance with NASDAQ’s listing requirements.
Because
two independent directors resigned in 2009 and Mr. Stanley Erck was appointed
Executive Chairman on February 15, 2010 rendering him no longer independent, the
majority of our Board of Directors is no longer independent. After disclosing
this fact to NASDAQ as required, we received a notice from NASDAQ confirming
that we are no longer in compliance with the NASDAQ requirements set forth in
Listing Rule 5605(b)(1), which requires that the Company’s Board of Directors be
comprised of a majority of independent directors. We have 45 days to submit a
plan to NASDAQ to regain compliance. The notification has no immediate effect on
the listing of Novavax’s common stock on The NASDAQ Global Market. The Company’s
common stock continues to trade on the NASDAQ Global Market under the symbol
NVAX.
Over
recent months, the Nominating and Corporate Governance Committee of Novavax’s
Board of Directors has been identifying, evaluating and recruiting potential
candidates for election to the Board of Directors. Novavax expects to elect two
independent directors and thus cure this non-compliance before its 2010 Annual
Meeting of Stockholders. We may not be able to attract and recruit qualified
individuals to serves as directors. Certain qualified individuals may demand
more compensation than we are willing to pay and we may not have two new
independent directors on a timely basis. If we are unable to add two new
independent directors and we do not receive an extension of time from the
NASDAQ, our listing on The NASDAQ Global Market may be affected.
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 $20 million
aggregate for all claims arising from the use of products in clinical trials
prior to FDA approval. Coverage is relatively expensive, and the market pricing
can significantly fluctuate. Therefore, we may not be able to maintain insurance
at a reasonable cost. There can be no assurance that we will be able to maintain
our existing insurance coverage or obtain coverage for the use of our other
products in the future. This insurance coverage and our resources may not be
sufficient to satisfy all liabilities resulting from product liability claims. A
successful claim may prevent us from obtaining adequate product liability
insurance in the future on commercially desirable items, if at all. Even if a
claim is not successful, defending such a claim would be time-consuming and
expensive, may damage our reputation in the marketplace, and would likely divert
management’s attention.
Regardless
of merit or eventual outcome, liability claims may result in:
|
·
|
decreased
demand for our products;
|
|
·
|
impairment
of our business reputation;
|
|
·
|
withdrawal
of clinical trial participants;
|
|
·
|
costs
of related litigation;
|
|
·
|
substantial
monetary awards to subjects or other
claimants;
|
|
·
|
inability
to commercialize our product
candidates.
|
There
are outstanding loans owed by certain of our former directors which may not be
repaid.
Two of
our former directors have outstanding notes due to the Company. The notes were
initially delivered by the former directors to us in March 2002 as payment of
the exercise price of options. As security, the former directors pledged shares
of our common stock as collateral. As of December 31, 2009, the outstanding
principal and interest for these two notes was $2.0 million. Both notes are
currently in default.
We are
uncertain about the collectability of these notes. At our current market prices,
we do not expect to recover the full amount outstanding under either note upon a
sale of pledged shares alone. We continue to actively work to collect the
amounts outstanding and reserve our rights to seek legal remedies currently
available to us. There are no assurances that the former directors will be able
to repay the notes in full.
Raising
additional capital by issuing securities or through collaboration and licensing
arrangements may cause dilution to existing stockholders or require us to
relinquish rights to our technologies or product candidates.
If we are
unable to partner with a third-party to advance the development of one or more
of our vaccine candidates, we will need to raise money through additional debt
or equity financings. To the extent that we raise additional capital by issuing
equity securities, our stockholders will experience immediate dilution which may
be significant. To the extent that we raise additional capital through licensing
arrangements or arrangements with collaborative partners, we may be required to
relinquish, on terms that may not be favorable to us, rights to some of our
technologies or product candidates that we would otherwise seek to develop or
commercialize ourselves. In addition, current economic conditions may also
negatively affect the desire or ability of potential collaborators to enter into
transactions with us. They may also have to delay or cancel research and
development projects or reduce their overall budgets.
PRODUCT
DEVELOPMENT RISKS
Because our vaccine product
development efforts depend on new and rapidly evolving technologies, we cannot
be certain that our efforts will be successful.
Our
vaccine work depends on new, rapidly evolving technologies and on the
marketability and profitability of our products. Commercialization of our
vaccine products could fail for a variety of reasons, and include the
possibility that:
|
·
|
our
VLP technology, any or all of the products based on VLP technology or our
proprietary manufacturing process will be ineffective or unsafe, or
otherwise fail to receive necessary regulatory clearances or commercial
viability;
|
|
·
|
we
are unable to scale-up our manufacturing capabilities in a cost effective
manner;
|
|
·
|
the
products, if safe and effective, will be difficult to manufacture on a
large-scale or uneconomical to
market;
|
|
·
|
our
pilot plant manufacturing facility will fail to continue to pass
regulatory inspections;
|
|
·
|
proprietary
rights of third-parties will prevent us or our collaborators from
exploiting technologies, manufacturing or marketing products;
and
|
|
·
|
third-party
competitors will gain greater market share due to superior products or
marketing capabilities.
|
We
have not completed the development of vaccine products and we may not succeed in
obtaining the FDA approval necessary to sell additional products.
The
development, manufacture and marketing of our pharmaceutical and biological
products are subject to government regulation in the United States and other
countries. In the United States and most foreign countries, we must complete
rigorous pre-clinical 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. None of our vaccine products have yet
gained regulatory approval in the United States or elsewhere. We also have
product candidates in human clinical trials and pre-clinical laboratory or
animal studies.
The steps
required by the FDA before our proposed investigational products may be marketed
in the United States include:
|
·
|
performance
of pre-clinical (animal and laboratory)
tests;
|
|
·
|
submissions
to the FDA of an IND which must become effective before human clinical
trials may commence;
|
|
·
|
performance
of adequate and well-controlled human clinical trials to establish the
safety and efficacy of the investigational product in the intended target
population;
|
|
·
|
performance
of a consistent and reproducible manufacturing process intended for
commercial use, including appropriate manufacturing data and regulatory
inspections;
|
|
·
|
submission
to the FDA of a BLA or a NDA; and
|
|
·
|
FDA
approval of the BLA or NDA before any commercial sale or shipment of the
product.
|
The
processes are expensive and can take many years to complete, and we may not be
able to demonstrate the safety and efficacy of our products to the satisfaction
of regulatory authorities. The start of clinical trials can be delayed or take
longer than anticipated for many and varied reasons, many of which are out of
our control. Safety concerns may emerge that could lengthen the ongoing trials
or require additional trials to be conducted. Regulatory authorities may also
require additional testing, and we may be required to demonstrate that our
proposed products represent an improved form of treatment over existing
therapies, which we may be unable to do without conducting further clinical
studies. Moreover, if the FDA or foreign regulatory body grants regulatory
approval of a product, the approval may be limited to specific indications or
limited with respect to its distribution. Expanded or additional indications for
approved products may not be approved, which could limit our revenue. Foreign
regulatory authorities may apply similar limitations or may refuse to grant any
approval. Consequently, even if we believe that pre-clinical and clinical data
are sufficient to support regulatory approval for our product candidates, the
FDA and foreign regulatory authorities may not ultimately grant approval for
commercial sale in any jurisdiction. If our vaccine candidates are not approved,
our ability to generate revenue will be limited and our business will be
adversely affected.
If
we are unable to manufacture our vaccines in sufficient quantities, at
sufficient yields or are unable to obtain regulatory approvals for a
manufacturing facility for our vaccines, we may experience delays in product
development, clinical trials, regulatory approval and commercial
distribution.
Completion
of our clinical trials and commercialization of our vaccine product candidates
require access to, or development of, facilities to manufacture our product
candidates at sufficient yields and at commercial scale. We have limited
experience manufacturing any of our product candidates in the volumes that will
be necessary to support large-scale clinical trials or commercial sales. Efforts
to establish capabilities may not meet initial expectations as to scheduling,
scale-up, reproducibility, yield, purity, cost, potency or quality.
If we are
unable to manufacture our product candidates in clinical quantities or, when
necessary, in commercial quantities and at sufficient yields, then we must rely
on third-parties. Other third-party manufacturers must also receive FDA approval
before they can produce clinical material or commercial products. Our vaccines
may be in competition with other products for access to these facilities and may
be subject to delays in manufacture if third-parties give other products greater
priority. We may not be able to enter into any necessary third-party
manufacturing arrangements on acceptable terms, or on a timely basis. In
addition, we have to enter into technical transfer agreements and share our
know-how with the third-party manufacturers, which can be time-consuming and may
result in delays.
Influenza
vaccines are intensely seasonal in nature. If a vaccine is not available early
enough in the influenza season, we would likely have difficulty selling the
vaccine. Further, pandemic outbreaks present only short-term opportunities for
the Company. There is no way to predict when there will be a pandemic outbreak,
the strain of the influenza or how long the pandemic will last. For these
reasons, any delay in the delivery of an influenza vaccine could result in lower
sales volumes, lower sale prices, or no sales. Because the strain of the
seasonal influenza changes annually, inventory of seasonal vaccine cannot be
sold during a subsequent influenza season. Any delay in the manufacture of our
influenza vaccines could adversely affect our ability to sell the
vaccines.
Our
reliance on contract manufacturers may adversely affect our operations or result
in unforeseen delays or other problems beyond our control. Because of
contractual restraints and the limited number of third-party manufacturers with
the expertise, required regulatory approvals and facilities to manufacture our
bulk vaccines on a commercial scale, replacement of a manufacturer may be
expensive and time-consuming and may cause interruptions in the production of
our vaccine. A third-party manufacturer may also encounter difficulties in
production. These problems may include:
|
·
|
difficulties
with production costs, scale-up and
yields;
|
|
·
|
availability
of raw materials and supplies;
|
|
·
|
quality
control and assurance;
|
|
·
|
shortages
of qualified personnel;
|
|
·
|
compliance
with strictly enforced federal, state and foreign regulations that vary in
each country where product might be sold;
and
|
|
·
|
lack
of capital funding.
|
As a
result, any delay or interruption could have a material adverse effect on our
business, financial condition, results of operations and cash
flows.
We
must identify products and product candidates for development with our VLP
technology and establish successful third-party relationships.
The near
and long-term viability of our vaccine product candidates will depend in part on
our ability to successfully establish new strategic collaborations with
pharmaceutical and biotechnology companies, non-profit organizations and
government agencies. Establishing strategic collaborations and obtaining
government funding is difficult and time-consuming. Potential collaborators may
reject collaborations based upon their assessment of our financial, regulatory
or intellectual property position or based on their internal pipeline;
government agencies may reject contract or grant applications based on their
assessment of public need, the public interest, our products’ ability to address
these areas, or other reasons beyond our expectations or control. If we fail to
establish a sufficient number of collaborations or government relationships on
acceptable terms, we may not be able to commercialize our vaccine product
candidates or generate sufficient revenue to fund further research and
development efforts.
Even if
we establish new collaborations or obtain government funding, these
relationships may never result in the successful development or
commercialization of any vaccine product candidates for several reasons,
including the fact that:
|
·
|
we
may not have the ability to control the activities of our partner and
cannot provide assurance that they will fulfill their obligations to us,
including with respect to the license, development and commercialization
of products and product candidates, in a timely manner or at
all;
|
|
·
|
such
partners may not devote sufficient resources to our products and product
candidates or properly maintain or defend our intellectual property
rights;
|
|
·
|
any
failure on the part of our partners to perform or satisfy their
obligations to us could lead to delays in the development or
commercialization of our products and product candidates, and affect our
ability to realize product revenue;
and
|
|
·
|
disagreements,
including disputes over the ownership of technology developed with such
collaborators, could result in litigation, which would be time-consuming
and expensive, and may delay or terminate research and development
efforts, regulatory approvals, and commercialization
activities.
|
Our
collaborators will be subject to the same regulatory approval of the
manufacturing facility and process as Novavax. Before we could begin commercial
manufacturing of any of our product candidates, we and our collaborators must
pass a pre-approval inspection before FDA approval and comply with the FDA’s
cGMP. If our collaborators fail to comply with these requirements, our product
candidates would not be approved. If our collaborators fail to comply with these
requirements after approval, we would be subject to possible regulatory action
and may be limited in the jurisdictions in which we are permitted to sell our
products.
If we or
our partners fail to maintain our existing agreements or in the event we fail to
establish agreements as necessary, we could be required to undertake research,
development manufacturing and commercialization activities solely at our own
expense. These activities would significantly increase our capital requirements
and, given our lack of sales, marketing and distribution capabilities,
significantly delay the commercialization of products and product
candidates.
Because
we depend on third-parties to conduct some of our laboratory testing, human
studies, and manufacturing, we may encounter delays in or lose some control over
our efforts to develop products.
We are
dependent on third-party research organizations to conduct some of our
laboratory testing, human studies and manufacturing activities. If we are unable
to obtain any necessary services on acceptable terms, we may not complete our
product development efforts in a timely manner. We may lose some control over
these activities and become too dependent upon these parties. These
third-parties may not complete testing or manufacturing activities on schedule,
within budget, or when we request. We may not be able to secure and maintain
suitable research organizations to conduct our laboratory testing, human studies
and manufacturing activities. We have not manufactured any of our product
candidates at a commercial level and may need to identify additional third-party
manufacturers to scale-up and manufacture our products.
We are
responsible for confirming that each of our clinical trials is conducted in
accordance with its general investigational plan and protocol. Moreover, the FDA
and foreign regulatory agencies require us to comply with regulations and
standards, commonly referred to as good clinical practices, for conducting,
recording and reporting the results of clinical trials to assure that data and
reported results are credible and accurate and that the trial participants are
adequately protected. The FDA and foreign regulatory agencies also require us to
comply with good manufacturing practices. Our reliance on third-parties does not
relieve us of these responsibilities and requirements. If these third-parties do
not successfully carry out their contractual duties or regulatory obligations or
meet expected deadlines, if the third-parties need to be replaced or if the
quality or accuracy of the data they obtain is compromised or the product they
manufacture is contaminated due to the failure to adhere to our clinical and
manufacturing protocols or regulatory requirements or for other reasons, our
pre-clinical development activities of clinical trials may be extended, delayed,
suspended or terminated, and we may not be able to obtain regulatory approval
of, or commercially manufacture, our product candidates.
Our
collaborations may not be profitable.
We have
entered into a co-marketing agreement with GEHC for a pandemic influenza vaccine
solution for select international countries. The collaboration incorporates
GEHC’s bioprocess solutions and design expertise with Novavax’s VLP
manufacturing platform. We have formed a joint venture with Cadila in India. In
connection with this joint venture, we agreed to a Master Services Agreement
under which we will purchase $7.5 million of services from Cadila or pay Cadila
all or a portion of the shortfall before March 2012. We cannot predict when, if
at all, these relationships will lead to approved products, sales, or otherwise
provide revenue to the Company or become profitable.
Even
though we have received governmental support in the past, we may not continue to
receive support at the same level or at all.
The
United States government, through its various agencies, has provided grants to
fund certain research and development efforts. There can be no assurances that
we will continue to receive the same level of funding from the United States
government, if at all. For example, the grants awarded to the Company to conduct
research related to HIV and SARS have expired and have not been renewed. We have
responded to the United States government (HHS BARDA) RFP for advanced
development of recombinant influenza vaccines. However, for various reasons,
including public need, program requirements, timing and other factors beyond our
control, we may not receive any funds under any government
programs.
We
have limited marketing capabilities, and if we are unable to enter into
collaborations with marketing partners or develop our own sales and marketing
capability, we may not be successful in commercializing any approved
products.
We
currently have no sales, marketing or distribution capabilities. As a result, we
will depend on collaborations with third-parties that have established
distribution systems and sales forces. To the extent that we enter into
co-promotion or other licensing arrangements, our revenue will depend upon the
efforts of third-parties, over which we may have little or no control. If we are
unable to reach and maintain agreements with one or more pharmaceutical
companies or collaborators, we may be required to market our products directly.
Developing a marketing and sales force is expensive and time-consuming and could
delay a product launch. We cannot be certain that we will be able to attract and
retain qualified sales personnel or otherwise develop this
capability.
Our
product candidates may never achieve market acceptance even if we obtain
regulatory approvals.
Even if
we receive regulatory approvals for the commercial sale of our product
candidates, the commercial success of these product candidates will depend on,
among other things, their acceptance by physicians, patients, third-party payers
such as health insurance companies and other members of the medical community as
a vaccine and cost-effective alternative to competing products. If our product
candidates fail to gain market acceptance, we may be unable to earn sufficient
revenue to continue our business. Market acceptance of, and demand for, any
product that we may develop and commercialize will depend on many factors,
including:
|
·
|
our
ability to provide acceptable evidence of safety and
efficacy;
|
|
·
|
the
prevalence and severity of adverse side
effects;
|
|
·
|
whether
our vaccines are differentiated from other vaccines based on
immunogenicity;
|
|
·
|
availability,
relative cost and relative efficacy of alternative and competing
treatments;
|
|
·
|
the
effectiveness of our marketing and distribution
strategy;
|
|
·
|
publicity
concerning our products or competing products and treatments;
and
|
|
·
|
our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
|
In
particular, there are significant challenges to market acceptance for seasonal
influenza vaccines. For our seasonal vaccine to be accepted, we must demonstrate
differentiation from other seasonal vaccines that are currently approved and
marketed. This can mean that the vaccine is more effective in certain
populations, such as the elderly, or cheaper and quicker to produce. While we
are currently conducting Phase II trials in the elderly, we have not yet
received any data and there are no assurances that our vaccine will be more
efficacious than other vaccines.
If our
product candidates do not become widely accepted by physicians, patients,
third-party payers and other members of the medical community, our business,
financial condition and results of operations would be materially and adversely
affected.
If
reforms in the health care industry make reimbursement for our potential
products less likely, the market for our potential products will be reduced, and
we could lose potential sources of revenue.
Our
success may depend, in part, on the extent to which reimbursement for the costs
of vaccines will be available from third-party payers such as government health
administration authorities, private health insurers, managed care programs and
other organizations. Over the past decade, the cost of health care has risen
significantly, and there have been numerous proposals by legislators, regulators
and third-party health care payers to curb these costs. Some of these proposals
have involved limitations on the amount of reimbursement for certain products.
Similar federal or state health care legislation may be adopted in the future
and any products that we or our collaborators seek to commercialize may not be
considered cost-effective. Adequate third-party insurance coverage may not be
available for us to establish and maintain price levels that are sufficient for
realization of an appropriate return on our investment in product development.
Moreover, the existence or threat of cost control measures could cause our
corporate collaborators to be less willing or able to pursue research and
development programs related to our product candidates.
REGULATORY
RISKS
We
may fail to obtain regulatory approval for our products on a timely basis or
comply with our continuing regulatory obligations after approval is
obtained.
Delays in
obtaining regulatory approval can be extremely costly in terms of lost sales
opportunities, losing any potential marketing advantage of being early to market
and increased trial costs. The speed with which we begin and complete our
pre-clinical trials necessary to begin human studies, human clinical trials and
our applications for marketing approval will depend on several factors,
including the following:
|
·
|
our
ability to manufacture or obtain sufficient quantities of materials for
use in necessary pre-clinical studies and clinical
trials;
|
|
·
|
prior
regulatory agency review and
approval;
|
|
·
|
Institutional
Review Board approval of the protocol and the informed consent
form;
|
|
·
|
the
rate of subject or patient enrollment and retention, which is a function
of many factors, including the size of the subject or patient population,
the proximity of subjects and patients to clinical sites, the eligibility
criteria for the study and the nature of the
protocol;
|
|
·
|
negative
test results or side effects experienced by trial
participants;
|
|
·
|
analysis
of data obtained from pre-clinical and clinical activities, which are
susceptible to varying interpretations and which interpretations could
delay, limit or prevent further studies or regulatory
approval;
|
|
·
|
the
availability of skilled and experienced staff to conduct and monitor
clinical studies and to prepare the appropriate regulatory applications;
and
|
|
·
|
changes
in the policies of regulatory authorities for drug or vaccine approval
during the period of product
development.
|
We have
limited experience in conducting and managing the pre-clinical studies and
clinical trials necessary to obtain regulatory marketing approvals. We may not
be permitted to continue or commence additional clinical trials. We also face
the risk that the results of our clinical trials may be inconsistent with the
results obtained in pre-clinical studies or clinical trials of similar products,
or that the results obtained in later phases of clinical trials may be
inconsistent with those obtained in earlier phases. A number of companies in the
biopharmaceutical and product development industry have suffered significant
setbacks in advanced clinical trials, even after experiencing promising results
in early animal and human testing.
Regulatory
agencies may require us or our collaborators to delay, restrict or discontinue
clinical trials on various grounds, including a finding that the subjects or
patients are being exposed to an unacceptable health risk. In addition, we or
our collaborators may be unable to submit applications to regulatory agencies
within the time frame we currently expect. Once submitted, applications must be
approved by various regulatory agencies before we or our collaborators can
commercialize the product described in the application. All statutes and
regulations governing the conduct of clinical trials are subject to change in
the future, which could affect the cost of such clinical trials. Any
unanticipated costs or delays in our clinical studies could delay our ability to
generate revenue and harm our financial condition and results of
operations.
Failure
to obtain regulatory approval in foreign jurisdictions would prevent us from
marketing our products internationally.
We intend
to have our product candidates marketed outside the United States. In
furtherance of this objective, we have entered into relationships with Cadila in
India and Avimex in Mexico. In order to market our
products in the European Union, Mexico, India, Asia and many other non-United
States jurisdictions, we must obtain separate regulatory approvals and comply
with numerous and varying regulatory requirements. To date, we have filed for
marketing approval for our 2009 H1N1 vaccine candidate in Mexico but may not
receive the approval necessary to commercialize our vaccine candidate in Mexico
or any market or may receive approval only after the commercial opportunity has
passed. The approval procedure varies among countries and can involve additional
testing and data review. The time required to obtain foreign regulatory approval
may differ from that required to obtain FDA approval. The foreign regulatory
approval process may include all of the risks associated with obtaining FDA
approval. We may not obtain foreign regulatory approvals on a timely basis, if
at all. Approval by a regulatory agency, such as the FDA, does not ensure
approval by any other regulatory agencies, for example in other foreign
countries. However, a failure or delay in obtaining regulatory approval in one
jurisdiction may have a negative effect on the regulatory approval process in
other jurisdictions, including approval by the FDA. The failure to obtain
regulatory approval in foreign jurisdictions could harm our
business.
Even
if regulatory approval is received for our product candidates, the later
discovery of previously unknown problems with a product, manufacturer or
facility may result in restrictions, including withdrawal of the product from
the market.
Even if a
product gains regulatory approval, such approval is likely to limit the
indicated uses for which it may be marketed, and the product and the
manufacturer of the product will be subject to continuing regulatory review,
including adverse event reporting requirements and the FDA’s general prohibition
against promoting products for unapproved uses. Failure to comply with any
post-approval requirements can, among other things, result in warning letters,
product seizures, recalls, substantial fines, injunctions, suspensions or
revocations of marketing licenses, operating restrictions and criminal
prosecutions. Any of these enforcement actions, any unanticipated changes in
existing regulatory requirements or the adoption of new requirements, or any
safety issues that arise with any approved products, could adversely affect our
ability to market products and generate revenue and thus adversely affect our
ability to continue our business.
We also
may be restricted or prohibited from marketing or manufacturing a product, even
after obtaining product approval, if previously unknown problems with the
product or its manufacture are subsequently discovered and we cannot provide
assurance that newly discovered or developed safety issues will not arise
following any regulatory approval. With the use of any vaccine by a wide patient
population, serious adverse events may occur from time to time that initially do
not appear to relate to the vaccine itself, and only if the specific event
occurs with some regularity over a period of time does the vaccine become
suspect as having a causal relationship to the adverse event. Any safety issues
could cause us to suspend or cease marketing of our approved products, possibly
subject us to substantial liabilities, and adversely affect our ability to
generate revenue and our financial condition.
Because
we are subject to environmental, health and safety laws, we may be unable to
conduct our business in the most advantageous manner.
We are
subject to various laws and regulations relating to safe working conditions,
laboratory and manufacturing practices, the experimental use of animals,
emissions and wastewater discharges, and the use and disposal of hazardous or
potentially hazardous substances used in connection with our research, including
infectious disease agents. We also cannot accurately predict the extent of
regulations that might result from any future legislative or administrative
action. Any of these laws or regulations could cause us to incur additional
expense or restrict our operations.
Our
facility in Maryland is subject to various local, state and federal laws and
regulations relating to safe working conditions, laboratory and manufacturing
practices, the experimental use of animals and the use and disposal of hazardous
or potentially hazardous substances, including chemicals, microorganisms and
various hazardous compounds used in connection with our research and development
activities. In the United States, these laws include the Occupational Safety and
Health Act, the Toxic Test Substances Control Act and the Resource Conservation
and Recovery Act. We cannot eliminate the risk of accidental contamination or
discharge or injury from these materials. Federal, state, and local laws and
regulations govern the use, manufacture, storage, handling and disposal of these
materials. We could be subject to civil damages in the event of an improper or
unauthorized release of, or exposure of individuals to, these hazardous
materials. In addition, claimants may sue us for injury or contamination that
results from our use or the use by third-parties of these materials, and our
liability may exceed our total assets. Compliance with environmental laws and
regulations may be expensive, and current or future environmental regulations
may impair our research, development or production efforts.
Although
we have general liability insurance, these policies contain exclusions from
insurance against claims arising from pollution from chemical or pollution from
conditions arising from our operations. Our collaborators are working with these
types of hazardous materials in connection with our collaborations. In the event
of a lawsuit or investigation, we could be held responsible for any injury we or
our collaborators cause to persons or property by exposure to, or release of,
any hazardous materials. However, we believe that we are currently in compliance
with all applicable environmental and occupational health and safety
regulations.
INTELLECTUAL
PROPERTY RISKS
Our
success depends on our ability to maintain the proprietary nature of our
technology.
Our
success in large part depends on our ability to maintain the proprietary nature
of our technology and other trade secrets. To do so, we must prosecute and
maintain existing patents, obtain new patents and pursue trade secret and other
intellectual property protection. We also must operate without infringing the
proprietary rights of third-parties or allowing third-parties to infringe our
rights. We currently have or have rights to over 99 United States patents and
corresponding foreign patents and patent applications covering our technologies.
However, patent issues relating to pharmaceuticals and biologics involve complex
legal, scientific and factual questions. To date, no consistent policy has
emerged regarding the breadth of biotechnology patent claims that are granted by
the United States Patent and Trademark Office or enforced by the federal courts.
Therefore, we do not know whether our patent applications will result in the
issuance of patents, or that any patents issued to us will provide us with any
competitive advantage. We also cannot be sure that we will develop additional
proprietary products that are patentable. Furthermore, there is a risk that
others will independently develop or duplicate similar technology or products or
circumvent the patents issued to us.
There is
a risk that third-parties may challenge our existing patents or claim that we
are infringing their patents or proprietary rights. We could incur substantial
costs in defending patent infringement suits or in filing suits against others
to have their patents declared invalid or claim infringement. It is also
possible that we may be required to obtain licenses from third-parties to avoid
infringing third-party patents or other proprietary rights. We cannot be sure
that such third-party licenses would be available to us on acceptable terms, if
at all. If we are unable to obtain required third-party licenses, we may be
delayed in or prohibited from developing, manufacturing or selling products
requiring such licenses.
Although
our patent filings include claims covering various features of our products and
product candidates, including composition, methods of manufacture and use, our
patents do not provide us with complete protection against the development of
competing products. Some of our know-how and technology is not patentable. To
protect our proprietary rights in unpatentable intellectual property and trade
secrets, we require employees, consultants, advisors and collaborators to enter
into confidentiality agreements. These agreements may not provide meaningful
protection for our trade secrets, know-how or other proprietary
information.
If
we infringe or are alleged to infringe the intellectual property rights of
third-parties, it will adversely affect our business, financial condition and
results of operations.
Our
research, development and commercialization activities, including any product
candidates or products resulting from these activities, may infringe or be
claimed to infringe patents owned by third-parties and to which we do not hold
licenses or other rights. There may be rights we are not aware of, including
applications that have been filed but not published that, when issued, could be
asserted against us. These third-parties could bring claims against us, and that
would cause us to incur substantial expenses and, if successful against us,
could cause us to pay substantial damages. Further, if a patent infringement
suit were brought against us, we could be forced to stop or delay research,
development, manufacturing or sales of the product or biologic drug candidate
that is the subject of the suit.
As a
result of patent infringement claims, or in order to avoid potential claims, we
may choose or be required to seek a license from the third-party. These licenses
may not be available on acceptable terms, or at all. Even if we are able to
obtain a license, the license would likely obligate us to pay license fees or
royalties or both, and the rights granted to us might be non-exclusive, which
could result in our competitors gaining access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product, or
be forced to cease some aspect of our business operations, if, as a result of
actual or threatened patent infringement claims, we are unable to enter into
licenses on acceptable terms. All of the issues described above could also
impact our collaborators, which would also impact the success of the
collaboration and therefore us.
There has
been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries.
In addition to infringement claims against us, we may become a party to other
patent litigation and other proceedings, including interference proceedings
declared by the United States Patent and Trademark Office and opposition
proceedings in the European Patent Office, regarding intellectual property
rights with respect to our products and technology.
We
may become involved in lawsuits to protect or enforce our patents or the patents
of our collaborators or licensors, which could be expensive and
time-consuming.
Competitors
may infringe our patents or the patents of our collaborators or licensors. As a
result, we may be required to file infringement claims to counter infringement
for unauthorized use. This can be expensive, particularly for a company of our
size, and time-consuming. In addition, in an infringement proceeding, a court
may decide that a patent of ours is not valid or is unenforceable, or may refuse
to stop the other party from using the technology at issue on the grounds that
our patents do not cover its technology. An adverse determination of any
litigation or defense proceedings could put one or more of our patents at risk
of being invalidated or interpreted narrowly and could put our patent
applications at the risk of not issuing.
Interference
proceedings brought by the United States Patent and Trademark Office may be
necessary to determine the priority of inventions with respect to our patent
applications or those of our collaborators or licensors. Litigation or
interference proceedings may fail and, even if successful, may result in
substantial costs and distraction to our management. We may not be able, alone
or with our collaborators and licensors, to prevent misappropriation of our
proprietary rights, particularly in countries where the laws may not protect
such rights as fully as in the United States.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of litigation.
In addition, during the course of this kind of litigation, there could be public
announcements of the results of hearings, motions or other interim proceedings
or developments. If investors perceive these results to be negative, the market
price for our common stock could be significantly harmed.
We
may need to license intellectual property from third-parties and, if our right
to use the intellectual property we license is affected, our ability to develop
and commercialize our product candidates may be harmed.
We expect
that we will need to license intellectual property from third-parties in the
future and that these licenses will be material to our business. We will not own
the patents or patent applications that underlie these licenses, and we will not
control the enforcement of the patents. We will rely upon our licensors to
properly prosecute and file those patent applications and prevent infringement
of those patents.
Our
license agreement with Wyeth Holdings Corporation, which gives us rights to a
family of patent applications covering VLP technology for use in human vaccines
in certain fields of use, is non-exclusive. These applications are very
significant to our business. Payments since inception, under this agreement,
have aggregated $5.1 million as of December 31, 2009. If each milestone is
achieved for any particular product candidate, we would be obligated to pay an
aggregate of $14 million to Wyeth Holdings for each product candidate developed
and commercialized under the agreement. Achievement of each milestone is subject
to many risks, including those described in these “Risk Factors.” Annual license
maintenance fees under the Wyeth Holdings agreement aggregate $0.3 million
per year. Our license with the University of Massachusetts gives us exclusive
rights to develop and commercialize vaccines incorporating certain virus-like
particles for use in human vaccines.
While
many of the licenses under which we have rights provide us with rights in
specified fields, the scope of our rights under these and other licenses may be
subject to dispute by our licensors or third-parties. In addition, our rights to
use these technologies and practice the inventions claimed in the licensed
patents and patent applications are subject to our licensors abiding by the
terms of those licenses and not terminating them. Any of our licenses may be
terminated by the licensor if we are in breach of a term or condition of the
license agreement, or in certain other circumstances.
Our
product candidates and potential product candidates will require several
components that may each be the subject of a license agreement. The cumulative
license fees and royalties for these components may make the commercialization
of these product candidates uneconomical.
If
patent laws or the interpretation of patent laws change, our competitors may be
able to develop and commercialize our discoveries.
Important
legal issues remain to be resolved as to the extent and scope of available
patent protection for biopharmaceutical products and processes in the United
States and other important markets outside the United States, such as Europe and
Japan. Foreign markets may not provide the same level of patent protection as
provided under the United States patent system. We expect that litigation or
administrative proceedings will likely be necessary to determine the validity
and scope of certain of our and others’ proprietary rights. Any such litigation
or proceeding may result in a significant commitment of resources in the future
and could force us to do one or more of the following: cease selling or using
any of our products that incorporate the challenged intellectual property, which
would adversely affect our revenue; obtain a license from the holder of the
intellectual property right alleged to have been infringed, which license may
not be available on reasonable terms, if at all; and redesign our products to
avoid infringing the intellectual property rights of third-parties, which may be
time-consuming or impossible to do. In addition, changes in, or different
interpretations of, patent laws in the United States and other countries may
result in patent laws that allow others to use our discoveries or develop and
commercialize our products. We cannot provide assurance that the patents we
obtain or the unpatented technology we hold will afford us significant
commercial protection.
RISKS
RELATED TO OUR COMMON STOCK AND ORGANIZATIONAL STRUCTURE
Because
our stock price has been and will likely continue to be highly volatile, the
market price of our common stock may be lower or more volatile than
expected.
Our stock
price has been highly volatile. The stock market in general and the market for
biopharmaceutical companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of particular
companies. From January 1, 2009 through December 31, 2009, the closing
price of our common stock has been as low as $0.56 per share and as high as
$6.65 per share.
The market price of our common stock may be influenced by many factors,
including:
|
·
|
future
announcements about our Company or our collaborators or competitors,
including the results of testing, technological innovations or new
commercial products;
|
|
·
|
clinical
trial results;
|
|
·
|
depletion
of our cash reserves;
|
|
·
|
sale
of equity securities or issuance of additional
debt;
|
|
·
|
announcement
by us of significant strategic partnerships, collaborations, joint
ventures, capital commitments or
acquisitions;
|
|
·
|
changes
in government regulations;
|
|
·
|
developments
in our relationships with our collaboration
partners;
|
|
·
|
announcements
relating to health care reform and reimbursement levels for new
vaccines;
|
|
·
|
sales
of substantial amounts of our stock by existing stockholders (including
stock by insiders or 5%
stockholders);
|
|
·
|
development,
spread or new announcements related to pandemic influenza, including H1N1
(swine) influenza;
|
|
·
|
public
concern as to the safety of our
products;
|
|
·
|
significant
set-backs or concerns with the industry or the market as a whole;
and
|
|
·
|
the
other factors described in this “Risk Factors”
section.
|
The stock
market has experienced extreme price and volume fluctuations that have
particularly affected the market price for many emerging and biopharmaceutical
companies. These fluctuations have often been unrelated to the operating
performance of these companies. These broad market fluctuations may cause the
market price of our common stock to be lower or more volatile than
expected.
We
have never paid dividends on our capital stock, and we do not anticipate paying
any such dividends in the foreseeable future.
We have
never paid cash dividends on our common stock. We currently anticipate that we
will retain all of our earnings for use in the development of our business and
do not anticipate paying any cash dividends in the foreseeable future. As a
result, capital appreciation, if any, of our common stock would be the only
source of gain for stockholders until dividends are paid, if at
all.
Provisions
of our Certificate of Incorporation and By-laws, Delaware law, and our
Shareholder Rights Plan could delay or prevent the acquisition of the Company,
even if such acquisition would be beneficial to stockholders, and could impede
changes in our Board.
Our
organizational documents could hamper a third-party’s attempt to acquire, or
discourage a third-party from attempting to acquire control of, the Company. We
have also adopted a shareholder rights plan, or “poison pill,” that empowers our
Board to delay or negotiate, and thereby possibly thwart, any tender offer or
takeover attempt the Board opposes. Stockholders who wish to participate in
these transactions may not have the opportunity to do so. These provisions also
could limit the price investors are willing to pay in the future for our
securities and make it more difficult to change the composition of our Board in
any one year. These provisions include the right of the Board to issue preferred
stock with rights senior to those of common stock without any further vote or
action by stockholders, the existence of a staggered Board with three classes of
directors serving staggered three-year terms and advance notice requirements for
stockholders to nominate directors and make proposals.
The
Company also is afforded the protections of Section 203 of the Delaware
General Corporation Law, which will prevent us from engaging in a business
combination with a person who acquires at least 15% of our common stock for a
period of three years from the date such person acquired such common stock,
unless advance board or stockholder approval was obtained.
Any delay
or prevention of a change of control transaction or changes in our Board of
Director or management could deter potential acquirers or prevent the completion
of a transaction in which our stockholders could receive a substantial premium
over the then current market price for their shares.
USE
OF PROCEEDS
We
currently intend to use the net proceeds from this offering for a variety of
corporate uses, including pre-clinical and clinical studies of our VLP-based
vaccines, internal research and development programs, working capital, capital
expenditures and other general corporate purposes.
At this
time, we have not determined the approximate amount of net proceeds that will be
allocated to each of the uses of proceeds stated above. In addition, we may use
the net proceeds we receive from this offering for a variety of other corporate
uses, including in-licenses or acquisitions of other products, technologies or
companies, although we currently have no commitments or agreements for any such
transactions. Our management will retain broad discretion as to the allocation
of the net proceeds from this offering. Pending application of the net proceeds
as described above, we intend to invest the proceeds in highly liquid,
investment-grade securities and money market funds.
DILUTION
If you
invest in our common stock, your interest will be diluted to the extent of the
difference between the price per share you pay in this offering and the net
tangible book value per share of our common stock immediately after this
offering. Our net tangible book value of our common stock as of December 31,
2009 was approximately $41.3 million, or approximately $0.41 per share of
common stock based upon 100,262,460 shares outstanding. Net tangible
book value per share is equal to our total tangible assets, less our total
liabilities, divided by the total number of shares outstanding as of December
31, 2009. While 25,000,000 shares are offered hereunder, we are limited to the
sale of common stock with gross proceeds aggregating
$50,000,000. Based on our closing price on March 11, 2010, the
maximum number of shares we could sell is 20,161,290. Assuming 20,161,290 shares
offered hereunder are sold and after giving effect to such sale, our as-adjusted
net tangible book value would have been approximately $90.3 million, or
approximately $0.75 per share of common stock based upon 120,423,750 shares
outstanding. This represents an immediate increase in net tangible book value of
$0.34 per share to our existing stockholders and an immediate dilution in net
tangible book value of $1.73 per share to new investors. The following table
illustrates this calculation on a per share basis:
Offering
price per share
|
|
|
|
|
|
$
|
2.48
(1)
|
|
Net
tangible book value per share as of December 31, 2009
|
|
$
|
0.41
|
|
|
|
|
|
Increase
in net tangible book value per share attributable to the
offering
|
|
$
|
0.34
|
|
|
|
|
|
As-adjusted
net tangible book value per share after giving effect to the
offering
|
|
|
|
|
|
$
|
0.75
|
|
Dilution
in net tangible book value per share to new investors
|
|
|
|
|
|
$
|
1.73
|
|
(1) Assuming
a purchase price of $2.48, the closing price of our common stock on March 11,
2010.
The
foregoing table excludes the following, each as of December 31,
2009:
|
·
|
5,994,994
shares of our common stock reserved for issuance upon the exercise of
outstanding stock options at a weighted average exercise price of $3.01
per share;
|
|
·
|
2,712,580
shares of our common stock reserved for future awards under our 2005 Stock
Incentive Plan; and
|
|
·
|
3,343,325
shares of our common stock reserved for issuance upon the exercise of
outstanding warrants.
|
PLAN
OF DISTRIBUTION
We have
entered into a sales agreement, dated March 15, 2010 with McNicoll, Lewis &
Vlak LLC (:MLV”), under which we may sell an aggregate of $50,000,000 in gross
proceeds of our common stock from time to time through MLV, as our agent for the
offer and sale of the common stock. Based on the trading price of our common
stock, we may not be able to sell all 25,000,000 shares offered herein or we may
not be able to raise the full $50,000,000 in gross proceeds permitted under the
sales agreements. MLV may sell the common stock by any method permitted by law,
including sales deemed to be an “at the market” offering as defined in
Rule 415 of the Securities Act, including without limitation sales made
directly on the NASDAQ Global Market, on any other existing trading market for
the common stock or to or through a market maker. MLV may also sell the common
stock in privately negotiated transactions, subject to our prior
approval.
Each time
that we wish to issue and sell common stock under the sales agreements, we will
provide MLV with a placement notice describing the number of shares to be
issued, the time period during which sales are requested to be made, any
limitation on the number of shares of common stock that may be sold in any one
day and any minimum price below which sales may not be made.
Upon
receipt of a placement notice from us, and subject to the terms and conditions
of the sales agreements, MLV has agreed to use its commercially reasonable
efforts consistent with its normal trading and sales practices to sell such
shares up to the amount specified on such terms. The settlement between us and
MLV of our common stock will occur on the third trading day following the date
on which the sale was made. The obligation of MLV under the sales agreements to
sell our common stock pursuant to a placement notice is subject to a number of
conditions.
We will
pay MLV a commission equal to 2% of the gross proceeds of the sale price per
share. Based on the closing price of our common stock on March 11, 2010, because
we are limited to the sale of common stock with gross proceeds aggregating
$50,000,000, the maximum number of shares we could sell is 20,161,290. If
20,161,290 shares of common stock were sold at the March 11, 2010 closing sales
price, we would receive $50,000,000 in gross proceeds, or $49,000,000 in
aggregate net proceeds assuming the sales agent fee is paid as described above.
The actual proceeds to us will vary. Because there is no minimum offering amount
required as a condition to the closing, the actual total may be less than the
maximum amount set forth above.
In
connection with the sale of our common stock contemplated in this prospectus,
MLV will be deemed to be an “underwriter” within the meaning of the
Securities Act of 1933, as amended, and the compensation paid to MLV will
be deemed to be underwriting commissions or discounts. We have agreed to
indemnify MLV against certain civil liabilities, including liabilities under the
Securities Act of 1933.
Sales of
our common stock as contemplated in this prospectus will be settled through the
facilities of The Depository Trust Company or by such other means as we and MLV
may agree upon.
The
offering of our common stock pursuant to the sales agreements will terminate on
the earliest of (1) the sale of all of our common stock subject to each
sales agreement, or (2) termination of the sales agreements by us or MLV. MLV
may terminate the sales agreements at any time in certain circumstances,
including the occurrence of a material adverse change that, in MLV’s reasonable
judgment, may impair its ability to sell the common stock, our failure to
satisfy any condition under of the sales agreements or a suspension or
limitation of trading of our common stock on NASDAQ. We may terminate the sales
agreements at any time upon 30 days prior notice, and MLV may terminate the
sales agreements at any time upon 60 days prior notice.
This is a
brief summary of the material provisions of the sales agreements and does not
purport to be a complete statement of its terms and conditions. A copy of each
sales agreement, as amended, is filed with the SEC and incorporated by reference
into the registration statement of which this prospectus forms a part. See
“Where You Can Find More Information.”
LEGAL
MATTERS
Certain
legal matters with respect to the securities offered hereby have been passed
upon by Ballard Spahr LLP.
EXPERTS
The
financial statements and management’s assessment of the effectiveness of
internal control over financial reporting incorporated by reference in this
prospectus and elsewhere in the registration statement have been so incorporated
by reference in reliance upon the report of Grant Thornton LLP, independent
registered public accountants, upon the authority of said firm as experts in
accounting and auditing in giving said reports.
LIMITATION
OF LIABILITY AND INDEMNIFICATION
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers and controlling persons, we have been
advised that, in the SEC’s opinion, such indemnification is against public
policy as expressed in the Securities Act and is, therefore,
unenforceable.
WHERE
YOU CAN FIND MORE INFORMATION
We are a
public company and file annual, quarterly and special reports, proxy statements
and other information with the SEC. You may read and copy any document we file
at the SEC’s public reference room at 100 F Street, NE,
Washington, D.C. 20549. You can request copies of these documents by
writing to the SEC and paying a fee for the copying cost. Please call the SEC at
1-800-SEC-0330 for more information about the operation of the public reference
room. Our SEC filings are also available to the public at the SEC’s website at
http://www.sec.gov. Our website address is www.novavax.com. However, information
on our website will not be considered a part of this prospectus.
INCORPORATION BY
REFERENCE
The SEC
allows us to “incorporate by reference” the information we file with it, which
means that we can disclose important information to you by referring you to
those documents. The information incorporated by reference is considered to be
part of this prospectus and the information we file later with the SEC prior to
the completion of this offering will automatically update and supersede this
information.
We
incorporate by reference the documents listed below and any future filings made
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934 until this offering is completed, provided however that we
are not incorporating by reference any documents or information deemed to have
been furnished and not filed in accordance with SEC rules. The documents that we
are incorporating by reference are:
|
·
|
Annual
Report on Form 10-K for the year ended December 31, 2009, filed on
March 16, 2010;
|
|
·
|
Current
Reports on Form 8-K filed on January 12, 2010, January 13, 2010, February
8, 2010, February 9, 2010, February 18, 2010 and March 17, 2010;
and
|
|
·
|
The
description of our common stock contained in the Registration Statement on
Form 10 filed with the SEC on September 14,
1995.
|
We will
furnish to you, on written or oral request, a copy of any or all of the
documents that have been incorporated by reference, including exhibits to these
documents. You may request a copy of these filings at no cost by writing or
telephoning Investor Relations at the following address and telephone
number:
9920
Belward Campus Drive
PART
II
INFORMATION NOT REQUIRED IN
PROSPECTUS
Item 14.
Other Expenses of Issuance and Distribution.
The costs
and expenses payable by the Company in connection with the offerings described
in this registration statement are as follows:
SEC
registration fee
|
|
$
|
10,695
|
|
Legal
fees and expenses
|
|
|
14,000
|
*
|
Accounting
fees and expenses
|
|
|
10,000
|
*
|
Printer
costs and expenses
|
|
|
2,000
|
|
Total
|
|
$
|
36,695
|
|
* Estimated
as permitted under Rule 511 of Regulation S-K.
Item 15.
Indemnification of Directors and Officers.
General
Corporation Law of Delaware
Section 145
of the General Corporation Law of Delaware provides that a corporation has the
power to indemnify a director, officer, employee or agent of the corporation and
certain other persons serving at the request of the corporation in related
capacities against amounts paid and expenses incurred in connection with an
action or proceeding to which he or she is or is threatened to be made a party
by reason of such position, if such person shall have acted in good faith and in
a manner he or she reasonably believed to be in or not opposed to the best
interests of the corporation, and, in any criminal proceeding, if such person
had no reasonable cause to believe his or her conduct was unlawful, provided that, in the case of
actions brought by or in the right of the corporation, no indemnification shall
be made with respect to any matter as to which such person shall have been
adjudged to be liable to the corporation unless and only to the extent that the
adjudicating court determines that such indemnification is proper under the
circumstances.
Amended
and Restated Certificate of Incorporation
Article NINTH
of Novavax’s Amended and Restated Certificate of Incorporation, as amended,
provides that a person (a) shall be indemnified against all expenses
(including attorneys’ fees), judgments, fines and amounts paid in settlement
incurred in connection with any threatened, pending or completed action, suit or
other proceeding (other than an action by or in the right of the Company) to
which he or she was or is a party or is threatened to be made a party by virtue
of his or her position as a director or officer of the Company or, at the
Company’s request, as a director, officer or trustee of another corporation,
partnership, joint venture, trust or other enterprise, if he or she acted in
good faith and in a manner he or she reasonably believed to be in, or not
opposed to, the best interests of the Company, and, with respect to any criminal
action or proceeding, had no reasonable cause to believe his conduct was
unlawful, and (b) shall be indemnified against all expenses (including
attorneys’ fees) and amounts paid in settlement incurred in connection with any
threatened, pending or completed action or suit by or in the right of the
Company to procure a judgment in the Company’s favor to which he or she was or
is a party or is threatened to be made a party by virtue of his or her position
as a director or officer of the Company or, at the Company’s request, as a
director, officer or trustee of another corporation, partnership, joint venture,
trust or other enterprise, if he or she acted in good faith and in a manner he
or she reasonably believed to be in, or not opposed to, the best interests of
the Company, except that no indemnification shall be made with respect to any
matter under (b) as to which such person shall have been adjudged to be
liable to the Company, unless and only to the extent that the Delaware Chancery
Court determines that, despite such adjudication but in view of all of the
circumstances, he or she is entitled to indemnification of such expenses.
Notwithstanding the foregoing, to the extent that a director or officer has been
successful, on the merits or otherwise, including, without limitation, the
dismissal of an action without prejudice, he or she is required to be
indemnified against all expenses (including attorneys’ fees) incurred in
connection therewith. Expenses shall be advanced to a director or officer at his
or her request; provided
that he or she undertakes to repay the amount advanced if it is
ultimately determined that he or she is not entitled to indemnification for such
expenses.
Indemnification
is required to be made unless the Company determines that the applicable
standard of conduct required for indemnification has not been met. In the event
of a determination by the Company that the director or officer did not meet the
applicable standard of conduct required for indemnification, or if the Company
fails to make an indemnification payment within 60 days after such payment is
claimed by such person, such person is permitted to petition the court to make
an independent determination as to whether such person is entitled to
indemnification. As a condition precedent to the right of indemnification, the
director or officer must give the Company notice of the action for which
indemnity is sought and the Company has the right to participate in such action
or assume the defense thereof.
Article NINTH
of Novavax’s Amended and Restated Certificate of Incorporation, as amended,
further provides that the indemnification provided therein is not exclusive, and
in the event that the General Corporation Law of Delaware is amended to expand
the indemnification permitted to directors or officers, the Company must
indemnify those persons to the fullest extent permitted by such law as so
amended. The Company is also permitted to maintain insurance to protect itself
and any director, officer, employee or agent against any expense, liability or
loss incurred by him or her in any such capacity, or arising out of his or her
status as such, whether or not the Company would have the power to indemnify
such person against such expense, liability or loss under the General
Corporation Law.
The
Company maintains insurance under which the insurers will reimburse the Company
for amounts that it has paid to its directors and officers as indemnification
for claims against such persons in their official capacities. The insurance also
covers such persons as to amounts paid by them as a result of claims against
them in their official capacities that are not reimbursed by the Company. The
insurance is subject to certain limitations and exclusions.
Indemnity
Agreements
The
Company has entered into indemnity agreements with each of its directors. Each
agreement provides that, with respect to third party proceedings, the Company is
obligated to indemnify a director if such director was or is a party or is
threatened to be made a party to any proceeding (other than a proceeding by or
in the right of the Company) by reason of the fact that he or she is or was a
director and/or officer of the Company, or is or was serving at the request of
the Company as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust, or other enterprise, against all “expenses”
(as defined in the agreements), judgments, fines and amounts paid in settlement
actually and reasonably incurred by the director (or on his or her behalf) in
connection with such proceeding. In order to be eligible for indemnification,
the director must have acted in good faith and in a manner which he or she
reasonably believed to be in or not opposed to the best interests of the Company
and, in the case of a criminal proceeding, had no reasonable cause to believe
that his or her conduct was unlawful.
The
Company is also obligated to provide indemnification if the director was or is a
party or is threatened to be made a party to any proceeding by or in the right
of the Company to procure a judgment in its favor by reason of the fact that the
individual is or was a director and/or officer of the Company, or is or was
serving at the request of the Company as a director, officer, employee or agent
of another corporation, partnership, joint venture, trust, or other enterprise,
against all expenses actually and reasonably incurred by the director (or on his
or her behalf) in connection with the defense or settlement of such proceeding
(or any claim, issue or matter therein). Again, no such indemnification is
permitted unless the indemnitee acted in good faith and in a manner which he or
she reasonably believed to be in or not opposed to the best interests of the
Company and, in the case of a criminal proceeding, had no reasonable cause to
believe that his or her conduct was unlawful. In addition, no indemnification
shall be made in respect of any claim, issue or matter as to which a director
shall have been adjudged to be liable to the Company unless and only to the
extent that the Delaware Court of Chancery (or other court in which such
proceeding was brought or is pending) determines that, despite the adjudication
of liability but in view of all the circumstances of the case, the director is
fairly and reasonably entitled to indemnity for such expenses as the court deems
proper.
To the
extent that a director has been successful on the merits or otherwise (whether
partially or in full) in defense of any proceeding referred to above, or in
defense of any claim, issue or matter therein, he or she shall be indemnified
against all expenses actually and reasonably incurred in connection therewith.
Moreover, indemnitees have the right to advancement by the Company prior to the
final disposition of any proceeding or any claim, issue or other matter therein
of any and all expenses incurred in defense of such proceeding or any claim,
issue or other matter.
A
director must repay any amounts actually advanced to him or her that, at the
final disposition of the proceeding to which the advance related, exceeded the
amounts paid or payable by the director. The Company must also have received an
undertaking by or on behalf of the director to repay such amounts to the extent
that it is ultimately determined that the director is not entitled to be
indemnified.
A
condition precedent to the right to be indemnified or receive advancement of
expenses is the delivery of written notice by the director to the Company as
soon as practicable of any proceeding for which indemnity or advancement will or
could be sought. A director will be entitled to indemnification so long as he or
she met the appropriate standard of conduct or was successful on the merits or
otherwise in defense of any such proceeding. Determination of a director’s
entitlement to indemnification will be made, in the case of a change in control,
by independent counsel to the Board and, in all other cases, by a majority vote
of disinterested directors (even though less than a quorum), independent
counsel, majority vote of a quorum of outstanding stock of all classes entitled
to vote, or a court of competent jurisdiction.
Item 16.
Exhibits.
The
exhibits marked with an asterisk are filed herewith. The remainder of the
exhibits have been previously filed with the SEC and are incorporated herein by
reference.
1.1+
|
Form
of Underwriting Agreement
|
1.2
|
At
Market Issuance Sales Agreement, dated March 15, 2010, by and between the
Registrant and McNicoll, Lewis & Vlak LLC. (Incorporated by reference
to Exhibit 10.37 to the Registrant’s Annual Report on Form 10-K for the
year ended December 31, 2009, filed March 16,
2010)
|
3.1
|
Amended
and Restated Certificate of Incorporation of the Registrant (Incorporated
by reference to Exhibit 3.1 to the Registrant’s Annual Report on Form
10-K for the fiscal year ended December 31, 1996, filed
March 21, 1997), as amended by the Certificate of Amendment dated
December 18, 2000 (Incorporated by reference to Exhibit 3.4 to
the Registrant’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2000, filed March 29, 2001), as further amended by
the Certificate of Amendment dated July 8, 2004 (Incorporated by
reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form
10-Q for the fiscal quarter ended June 30, 2004, filed August 9,
2004), as further amended by the Certificate of Amendment dated May 13,
2009 (Incorporated by reference to Exhibit 3.1 to the Registrant’s
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2009)
|
3.2
|
Amended
and Restated By-Laws of the Registrant. (Incorporated by reference to
Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed
August 8, 2007)
|
4.1
|
Rights
Agreement dated as of August 8, 2002, by and between Novavax, Inc.
and EquiServe Trust Company, N.A., as Rights Agent. The Rights Agreement
includes as Exhibit A the form of Summary of Rights to Purchase
Series D Junior Participating Preferred Stock, as Exhibit B the Form
of Right Certificate and as Exhibit C the Form of Certificate of
Designations of Series D Junior Participating Preferred Stock.
(Incorporated by reference to Exhibit 4.1 to the Registrant’s Current
Report on Form 8-K, filed August 9,
2002)
|
4.2
|
Specimen
stock certificate for shares of common stock, par value $.01 per share
(Incorporated by reference to Exhibit 4.1 to the Registrant’s
Registration Statement on Form 10, filed September 14,
1995)
|
4.3+
|
Form
of Common Stock Warrant Agreement (together with form of warrant
certificate)
|
4.4+
|
Form
of Preferred Stock Warrant Agreement (together with form of warrant
certificate)
|
4.5+
|
Form
of Certificate of Designation for Preferred Stock (including specimen
preferred stock certificate)
|
4.6+
|
Form
of Unit Agreement (including form of unit
certificate)
|
5.1
|
Opinion
of Ballard Spahr LLP (previously
filed)
|
23.1
|
Consent
of Grant Thornton LLP, Independent Registered Public Accounting Firm
(previously filed)
|
23.2
|
Consent
of Ballard Spahr LLP (previously
filed)
|
24.1
|
Power
of Attorney (previously filed)
|
+
|
To
be filed as an exhibit to a report filed pursuant to Sections 13(a),
13(c) or 15(d) of the Exchange Act or by post-effective amendment to the
Registration Statement.
|
Item 17.
Undertakings.
(a) The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i)
To include any prospectus required by section 10(a)(3) of the
Securities Act of 1933;
(ii)
To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information in the registration statement.
Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20% change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee”
table in the effective registration statement; and
(iii) To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement;
Provided, however,
that:
Paragraphs
(1)(i), (1)(ii) and (1)(iii) of this section do not apply if the information
required to be included in a post-effective amendment by those paragraphs is
contained in reports filed with or furnished to the Commission by the registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of
1934 that are incorporated by reference in the registration statement, or is
contained in a form of prospectus filed pursuant to Rule 424(b) that is part of
the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(5) That,
for the purpose of determining liability under the Securities Act of 1933 to any
purchaser:
(i) If
the registrant is relying on Rule 430B:
(A) Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be
deemed to be part of the registration statement as of the date the filed
prospectus was deemed part of and included in the registration statement;
and
(B) Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or
(b)(7) as part of a registration statement in reliance on Rule 430B
relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or
(x) for the purpose of providing the information required by Section 10(a)
of the Securities Act of 1933 shall be deemed to be part of and included in the
registration statement as of the earlier of the date such form of prospectus is
first used after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided in
Rule 430B, for liability purposes of the issuer and any person that is at
that date an underwriter, such date shall be deemed to be a new effective date
of the registration statement relating to the securities in the registration
statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof, provided, however, that no
statement made in a registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed incorporated
by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale
prior to such effective date, supersede or modify any statement that was made in
the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such effective date;
or
(ii) If
the registrant is subject to Rule 430C, each prospectus filed pursuant to
Rule 424(b) as part of a registration statement relating to an offering, other
than registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be deemed to be part of
and included in the registration statement as of the date it is first used after
effectiveness, provided,
however, that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document incorporated or
deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time
of contract of sale prior to such first use, supersede or modify any statement
that was made in the registration statement or prospectus that was part of the
registration statement or made in any such document immediately prior to such
date of first use.
(6) That,
for the purpose of determining liability of the registrant under the Securities
Act of 1933 to any purchaser in the initial distribution of the
securities:
The
undersigned registrant undertakes that in a primary offering of securities of
the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the
securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such
purchaser:
(i) Any
preliminary prospectus or prospectus of the undersigned registrant relating to
the offering required to be filed pursuant to Rule 424;
(ii) Any
free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned
registrant;
(iii) The
portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
(iv) Any
other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(b) The
undersigned registrant hereby further undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering
thereof.
(h) Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act of
1933, as amended, and is, therefore, unenforceable. In the event that a claim
for indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question of whether such
indemnification by it is against public policy as expressed in said act and will
be governed by the final adjudication of such issue.
(i) The
undersigned registrant hereby undertakes that:
(1) For
purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For
the purpose of determining any liability under the Securities Act of 1933, each
post-effective amendment that contains a form of prospectus shall be deemed to
be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of
Rockville, State of Maryland on the 25th day of March 2010.
NOVAVAX,
INC.
|
|
By:
|
/s/
Rahul Singhvi
|
|
Rahul
Singhvi, President
|
|
and
Chief Executive Officer
|
Pursuant to the requirements of the
Securities Act of 1933, as amended, this registration statement has been signed
by the following persons in the capacities and on the dates
indicated.
NAME
|
|
TITLE
|
|
DATE
|
|
|
|
|
|
/s/
Rahul Singhvi
|
|
President,
Chief Executive
|
|
March
25, 2010
|
Rahul
Singhvi |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Frederick W. Driscoll
|
|
Vice
President, Chief Financial
|
|
|
Frederick
W. Driscoll
|
|
Officer
and Treasurer
(Principal
|
|
|
|
|
Financial
Officer and Principal
|
|
|
|
|
Accounting
Officer)
|
|
|
|
|
|
|
|
*
|
|
Executive
Chairman of the
|
|
|
Stanley
C. Erck
|
|
Board
of Directors
|
|
|
|
|
|
|
|
*
|
|
Lead
Independent Director
|
|
|
Gary
C. Evans
|
|
|
|
|
*
|
|
Director
|
|
|
John
Lambert
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
|
John
O. Marsh, Jr.
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
|
Michael
A. McManus, Jr.
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
|
Rajiv
I. Modi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*By: |
/s/
Frederick W. Driscoll
|
|
|
|
March
25, 2010
|
|
Frederick
W. Driscoll
|
|
|
|
|
|
Attorney-in-Fact |
|
|
|
|