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| NVAX > SEC Filings for NVAX > Form 10-K/A on 12-Dec-2008 | All Recent SEC Filings |
12-Dec-2008
Annual Report
Overview
Novavax, Inc., a Delaware corporation ("Novavax" or the "Company"), was
incorporated in 1987, and is a clinical-stage pharmaceutical company focused on
creating differentiated, value-added vaccines that leverage the Company's
proprietary virus-like particle ("VLP") technology. VLPs imitate the
three-dimensional structures of viruses but are composed of recombinant proteins
and therefore, are believed incapable of causing infection and disease. Our
proprietary production technology uses insect cells rather than chicken or
mammalian eggs. The Company's current product targets include vaccines against
the H5N1, H9N2 and other subtypes of avian influenza with pandemic potential,
human seasonal influenza, Varicella Zoster, which causes shingles and a fourth
undisclosed disease target.
On July 31, 2007, the Company began Phase I/IIa clinical trials for its
H5N1 pandemic influenza vaccine. In December 2007, the Company announced
favorable interim results for its pandemic influenza vaccine that demonstrated
immunogenicity and safety. The Company plans to begin patient enrollment in the
second portion of the Phase I/IIa trial before March 31, 2008 to gather
additional patient immunogenicity and safety data, as well as determining a
final dose through completion of this clinical trial. It is anticipated that
initial immunogenicity and safety data will be available early in the third
quarter of 2008 with study completion by the end of 2008 to include on-going
safety data collection.
The Company also has a drug delivery platform based on its micellar
nanoparticle ("MNP") technology, proprietary oil and water nano emulsions used
for the topical delivery of drugs. The MNP technology was the basis for the
development of the Company's first Food and Drug Administration ("FDA") approved
estrogen replacement product known as Estrasorb®. In February 2008, the Company
sold assets related to Estrasorb® in the United States, Canada and Mexico to
Graceway Pharmaceuticals, LLC ("Graceway"). The Company is seeking to divest its
non-vaccine MNP technology through sales and licenses.
The Company's vaccine products currently under development or in clinical
trials will require significant additional research and development efforts,
including extensive pre-clinical and clinical testing and regulatory approval,
prior to commercial use. There can be no assurance that the Company's research
and development efforts will be successful or that any potential products will
prove to be safe and effective in clinical trials. Even if developed, these
vaccine products may not receive regulatory approval or be successfully
introduced and marketed at prices that would permit the Company to operate
profitably. The commercial launch of any vaccine product is subject to certain
risks including, but not limited to, manufacturing scale-up and market
acceptance. No assurance can be given that the Company can generate sufficient
product revenue to become profitable or generate positive cash flow from
operations at all or on a sustained basis. The Company's efforts to divest the
MNP technology may not be successful because the Company may not be able to
identify a potential licensee or buyer and, even if the Company does identify a
licensee or buyer, the price and terms may not be acceptable to the Company.
Summary of Significant Transactions
Graceway Agreements
In February 2008, the Company entered into an asset purchase agreement with
Graceway Pharmaceuticals, LLC ("Graceway"), pursuant to which Novavax sold
Graceway its assets related to Estrasorb® in the United States, Canada and
Mexico. The assets sold include certain patents related to the micellar
nanoparticle technology (the "MNP Technology"), trademarks, know-how,
manufacturing equipment, customer and supplier relations, goodwill and other
assets. Novavax retained the rights to commercialize Estrasorb® outside of the
United States, Canada and Mexico.
In February 2008, Novavax and Graceway also entered into a supply
agreement, pursuant to which Novavax has agreed to manufacture additional units
of Estrasorb with final delivery expected in July 2008. Graceway will pay a
preset transfer price per unit of Estrasorb for the supply of this product. Once
Novavax has delivered the required quantity of Estrasorb, Novavax must clean the
manufacturing equipment and prepare the equipment for transport. Graceway will
remove the equipment from the manufacturing facility and Novavax will then exit
the facility.
In February 2008, Novavax and Graceway also entered into a license
agreement, pursuant to which Graceway granted Novavax an exclusive,
non-transferable (except for certain allowed assignments and sublicenses),
royalty-free, limited license to the patents and know-how that Novavax sold to
Graceway pursuant to the asset purchase agreement. The licensed grant allows
Novavax to make, use and sell licensed products and services in certain, limited
fields.
The net cash proceeds from these transactions are expected to be in excess
of $2.0 million over the first half of 2008. The license and supply agreements
with Allergan, Inc., successor-in-interest to Esprit Pharma, Inc., were
terminated in February 2008 and October 2007, respectively.
License Agreement with Wyeth Holdings Corporation
On July 5, 2007, we entered into a License Agreement with Wyeth Holdings
Corporation, a subsidiary of Wyeth ("Wyeth"). The license is a non-exclusive,
worldwide license to a family of patent applications covering VLP technology for
use in human vaccines in certain fields of use. The agreement provides for an
upfront payment, annual license fees, milestone payments and royalties on any
product sales. Payments under the agreement to Wyeth as of December 31, 2007
aggregated $1.5 million and could aggregate up to an additional $6.5 million in
2008, depending on the achievement of clinical development milestones. The
royalty to be paid by the Company under the agreement, if a product is approved
by the FDA for commercialization, will be based on single digit percentage of
net sales. The agreement will remain effective as long as at least one claim of
the licensed patent rights cover the manufacture, sale or use of any product
unless terminated sooner at Novavax's option or by Wyeth for an uncured breach
by Novavax.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, we entered into a worldwide agreement to
exclusively license a VLP technology from the University of Massachusetts
Medical School ("UMMS"). Under the agreement, we have the right to use this
technology to develop VLP vaccines for the prevention of any viral diseases in
humans. As of December 31, 2007, we made payments to UMMS in an aggregate amount
that is not material to the Company. In addition, we will make certain payments
based on development milestones as well as future royalties on any sales of
products that may be developed using the technology. The Company believes that
all payments under the UMMS agreement will not be material to the Company in the
foreseeable future. The UMMS agreement will remain effective as long as at least
one claim of the licensed patent rights cover the manufacture, sale or use of
any product unless terminated sooner at Novavax's option or by UMMS for an
uncured breach by Novavax.
Sublease Agreement with PuriCore, Inc.
In April 2006, we entered into a sublease agreement with Sterilox
Technologies, Inc. (now known as PuriCore, Inc.) to sublease 20,469 square feet
of the Company's Malvern, Pennsylvania corporate headquarters at a premium price
per square foot. The sublease, with a commencement date of July 1, 2006, expires
on September 30, 2009. This sublease is consistent with our strategic focus to
increase our presence in Rockville, Maryland, where our vaccine operations are
currently located. In line with that strategy, in October 2006, we entered into
a lease for an additional 51,000 square feet in Rockville, Maryland.
Accordingly, in October 2006, the Company entered into an amendment to the
Sublease Agreement with PuriCore, Inc. to sublease an additional 7,500 square
feet of the Malvern corporate headquarters at a premium price per square foot.
This amendment has a commencement date of October 25, 2006 and expires
concurrent with the initial lease on September 30, 2009.
Convertible Notes
On June 15, 2007, we entered into amendment agreements (the "Amendments")
with each of the holders of the outstanding 4.75% senior convertible notes (the
"Notes") to amend the terms of the Notes. As of December 31, 2007, $22.0 million
aggregate principal amount remained outstanding under the Notes. The Amendments
(i) lowered the conversion price from $5.46 to $4.00 per share, (ii) eliminated
the holders' right to require the Company to redeem the Notes if the weighted
average price of the Company's common stock is less than the conversion price on
30 of the 40 consecutive trading days preceding July 19, 2007 or July 19, 2008
and (iii) mandated that the Notes be converted into Company common stock if the
weighted average price of the Company's common stock is greater than $7.00 (a
decrease from $9.56) in any 15 out of 30 consecutive trading days after July 19,
2007.
Notes with Former Directors
In March 2002, pursuant to the Novavax, Inc. 1995 Stock Option Plan, we
approved the payment of the exercise price of. options by two of directors
through the delivery of full-recourse, interest-bearing promissory notes in the
aggregate amount of $1,480,000. The notes were secured by an aggregate of
261,667 shares of our common stock.
In May 2006, one of these directors resigned from the Company's board of
directors. Following his resignation, the Company approved an extension of the
former director's $448,000 note to be payable on December 31, 2007, or earlier
to the extent of the net proceeds from any sale of the pledged shares. This note
has not yet been paid and the Company and the former director are currently
negotiating the terms of an extension.
In March 2007, the other director resigned. Following his resignation, the
Company approved an extension of the former director's $1,031,668 note. The note
continues to accrue interest at 5.07% per annum and is secured by shares of
common stock owned by the former director and is payable on June 30, 2009, or
earlier to the extent of the net proceeds from any sale of the pledged shares.
In addition, the Company has the option to sell the pledged shares on behalf of
the former director at any time that the market price of our common stock, as
reported on NASDAQ Global Market, exceeds $7.00 per share.
As of December 31, 2007, the Company has reserved an amount of $1,041,005
for the outstanding note receivables. This amount has been netted against the
pledged common stock. Due to heightened sensitivity in the current environment
surrounding related-party transactions and the extensions of the maturity dates,
these transactions could be viewed negatively in the market and our stock price
could be negatively affected.
Critical Accounting Policies and Use of Estimates
We prepare our consolidated financial statements in conformity with
accounting principles generally accepted in the United States. Such accounting
principles require that our management make estimates and assumptions that
affect the reported amount of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period. We
base our estimates on historical and anticipated results and trends and on
various other assumptions that we believe are reasonable under the
circumstances, including assumptions as to future events. These estimates form
the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. By their nature,
estimates are subject to an inherent degree of uncertainty. Actual results could
differ materially from these estimates. The items in our consolidated financial
statements that have required us to make significant estimates and judgments are
as follows:
Revenue Recognition and Allowances
The Company recognizes revenue in accordance with the provisions of Staff
Accounting Bulletin No. 104, Revenue Recognition ("SAB No. 104"). For product
sales, revenue is recognized when all of the following criteria are met:
persuasive evidence of an arrangement exists, delivery has occurred, the price
is fixed and determinable and collectability is reasonably assured. The Company
establishes allowances for estimated uncollectible amounts, product returns,
rebates and charge backs based on historical trends and specifically identified
problem accounts. A large part of the Company's product sales are to Allergan or
to distributors who resell the products to their customers. The Company provides
rebates to members of certain buying groups who purchase from the Company's
distributors, to distributors that sell to their customers at prices determined
under a contract between the Company and the customer, and to state agencies
that administer various programs such as the federal Medicaid and Medicare
programs. Rebate amounts are usually based upon the volume of purchases or by
reference to a specific price for a product. The Company estimates the amount of
the rebate that will be paid, and records the liability as a reduction of
revenue when the Company records the sale of the products. Settlement of the
rebate generally occurs from three to twelve months after the sale. The Company
regularly analyzes the historical rebate trends and adjusts recorded reserves
for changes in trends, distributor inventory levels, product prescription data
and generic competition.
The shipping and handling costs the Company incurs are included in cost of
products sold in its statements of operations.
For upfront payments and licensing fees related to contract research or
technology, the Company follows the provisions of SAB No. 104 in determining if
these payments and fees represent the culmination of a separate earnings process
or if they should be deferred and recognized as revenue as earned over the life
of the related agreement. Milestone payments are recognized as revenue upon
achievement of contract-specified events and when there are no remaining
performance obligations. Revenue earned under research contracts is recognized
in accordance with the terms and conditions of such contracts for reimbursement
of costs incurred and defined milestones.
SFAS No. 123R
As of January 1, 2006 ("effective date"), we adopted SFAS No. 123R in
accounting for stock options issued to our employees, directors and consultants
using the modified prospective method. The modified prospective method requires
that compensation costs be recognized for all share-based payments granted after
the effective date and for all awards granted prior to the effective date that
are unvested using the requirements of SFAS No. 123R. Prior to the adoption of
SFAS No. 123R, we accounted for our stock-based compensation using the
principles of Accounting Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees ("APB No. 25") as permitted by Statement of Financial
Accounting Standards No. 123, Accounting for Stock Based Compensation ("SFAS No.
123"). APB No. 25 generally did not require that options granted to employees be
expensed. Since we elected to use the modified prospective method, there are no
one-time effects from the adoption of SFAS No. 123R, such as a cumulative effect
adjustment.
There were no modifications to outstanding stock options as of December 31, 2006 and 2007. There have been no changes in the quantity or type of instruments used in share-based payment programs. There has been no material modifications to the valuation methodologies or assumptions from those used in estimating the fair value of options under SFAS No. 123 other than the adjustments for expected volatility. Prior to the adoption of SFAS. No. 123R, we utilized the preceding 12 month period historical stock prices in determining the expected volatility. With the adoption of SFAS No. 123R, we use the historical volatilities based on stock prices since the inception of the stock plans in determining the expected volatility. Forfeiture rates are estimated based on historical activities since the inception of the stock plans. There have been no changes in the normal terms of share-based payment agreements. For grants awarded prior to January 1, 2006, we accounted for compensation cost using a graded method. For grants awarded on or after January 1, 2006, we accounted for compensation cost using a straight-line method. As of December 31, 2007, the aggregate fair value of the remaining compensation cost of unvested options, as determined using a Black-Scholes option valuation model, was approximately $2,438,000 (net of estimated forfeitures). This remaining compensation cost is expected to be recognized over a weighted average period of 1.6 years. The Company recorded compensation costs in the Consolidated Statements of Operations associated with SFAS No. 123 as follows:
Years Ended
December 31,
2007 2006
(In thousands)
Cost of products sold (which includes idle capacity) $ 35 $ 48
Research and development 573 561
General and administrative 737 1,167
Total effect of adopting SFAS No. 123R $ 1,345 $ 1,776
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Research and Development
Research and development costs are expensed as incurred. Such costs include
internal research and development expenditures (such as salaries and benefits,
raw materials and supplies) and contracted services (such as sponsored research,
consulting and testing services) of proprietary research and development
activities and similar expenses associated with collaborative research
agreements.
Income Taxes
The Company's income taxes are accounted for using the liability method.
Under the liability method, deferred income taxes are recognized for the future
tax consequences attributable to differences between the consolidated financial
statement carrying amounts of existing assets and liabilities and their
respective tax basis and operating loss carry forward. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable
income in the year in which those temporary differences are expected to be
recovered or settled.
The effect of changes in tax rates on deferred tax assets and liabilities
is recognized in operations in the period that includes the enactment date. A
valuation allowance is established when necessary to reduce net deferred tax
assets to the amount expected to be realized. The Company has provided a full
valuation allowance against its net deferred tax assets as of December 31, 2007
and 2006.
Goodwill and Intangible Assets
Goodwill originally results from business acquisitions. Assets acquired and
liabilities assumed are recorded at their fair values; the excess of the
purchase price over the identifiable net assets acquired is recorded as
goodwill. Other intangible assets are a result of product acquisitions,
non-compete arrangements and internally discovered patents. In accordance with
SFAS No. 142, Goodwill and Other Intangible Assets ("SFAS No. 142") goodwill and
intangible assets deemed to have indefinite lives are not amortized but are
subject to impairment tests annually, or more frequently should indicators of
impairment arise. The Company utilizes a discounted cash flow analysis that
includes profitability information, estimated future operating results, trends
and other information in assessing whether the value of the indefinite-lived
intangible assets can be recovered. Under SFAS No. 142, goodwill impairment is
deemed to exist if the carrying value of a reporting unit exceeds its estimated
fair value. In accordance with the requirements of SFAS No. 142, the Company
initially tested its goodwill for impairment as of January 1, 2002 and
determined that no impairment was present. The Company thereafter performed the
required annual impairment test as of December 31 of each year on the carrying
amount of its goodwill.
Disposal of Long-Lived Assets/Discontinued Operations
We account for the impairment of long-lived assets and long-lived assets to
be disposed of in accordance with Statement of Financial Accounting Standard
No. 144, Accounting for the Impairment or Disposal ("SFAS No. 144"). SFAS
No. 144 requires a periodic evaluation of the recoverability of the carrying
value of long-lived assets and identifiable intangibles and whenever events or
changes in circumstances indicate that the carrying value of the asset may not
be recoverable. Examples of events or changes in circumstances that indicate
that the recoverability of the carrying value of an asset should be assessed
include, but are not limited to, the following: a significant decrease in the
market value of an asset, a significant change in the extent or manner in which
an asset is used, a significant physical change in an asset, a significant
adverse change in legal factors or in the business climate that could affect the
value of an asset, an adverse action or assessment by a regulator, an
accumulation of costs significantly in excess of the amount originally expected
to acquire or construct an asset, a current period operating or cash flow loss
combined with a history of operating or cash flow losses, and/or a projection or
forecast that demonstrates continuing losses associated with an asset used for
the purpose of producing revenue. We consider historical performance and
anticipated future results in its evaluation of potential impairment.
Accordingly, when indicators of impairment are present, we evaluate the carrying
value of these assets in relation to the operating performance of the business
and future undiscounted cash flows expected to result from the use of these
assets. Impairment losses are recognized when the sum of expected future cash
flows is less than the assets' carrying value. SFAS No. 144 also provides
accounting and reporting provisions for components of an entity that are
classified as discontinued operations. We recorded an impairment loss in
connection with the discontinued operations of its Philadelphia, Pennsylvania
manufacturing facility for the year ended December 31, 2007 (See Note 11 -
Discontinued Operations).
Recent Accounting Pronouncements
Other than the adoption of FASB interpretation No. 48, Accounting for
Uncertainty in Income Taxes ("FIN 48") there have been no material changes in
our critical accounting policies or critical accounting estimates since
December 31, 2006, nor have we adopted any accounting policy that has or will
have a material impact on our consolidated financial statements. For further
discussion of our accounting policies see Note 2 "Summary of Significant
Accounting Policies" in the Notes to the Consolidated Financial Statements
included herewith.
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