Attached files
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EX-32.2 - NOVAVAX INC | v201348_ex32-2.htm |
EX-31.1 - NOVAVAX INC | v201348_ex31-1.htm |
EX-31.2 - NOVAVAX INC | v201348_ex31-2.htm |
EX-32.1 - NOVAVAX INC | v201348_ex32-1.htm |
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-Q
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended September 30, 2010
OR
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period
from to .
Commission
File No. 0-26770
NOVAVAX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
22-2816046
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
9920
Belward Campus Drive, Rockville, MD
|
20850
|
(Address
of principal executive offices)
|
(Zip
code)
|
(240)
268-2000
Indicate by check mark whether the
Registrant: (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the Registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past
90 days. Yes x No ¨
Indicate by check mark whether the
registrant has submitted electronically and posted on its corporate Web site, if
any, every Interactive Data File required to be submitted and posted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was
required to submit and post such files). Yes ¨ No ¨
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
the 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 ¨
|
(Do
not check if a smaller reporting
company)
|
Indicate by check mark whether
the Registrant is a shell
company (as defined in Rule 12b-2 of the Exchange
Act). Yes ¨ No x
The
number of shares outstanding of the Registrant’s Common Stock, $0.01 par value,
was 111,101,416 as
of October 31, 2010.
NOVAVAX,
INC.
TABLE
OF CONTENTS
Page No.
|
||||
PART
I. FINANCIAL INFORMATION
|
||||
Item
1.
|
Financial
Statements
|
|||
Consolidated
Balance Sheets as of September 30, 2010 (unaudited) and December 31,
2009
|
1
|
|||
Consolidated
Statements of Operations for the three and nine months ended September 30,
2010 and 2009 (unaudited)
|
2
|
|||
Consolidated
Statements of Cash Flows for the nine months ended September 30, 2010 and
2009 (unaudited)
|
3
|
|||
Notes
to the Consolidated Financial Statements (unaudited)
|
4
|
|||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
11
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
19
|
||
Item
4.
|
Controls
and Procedures
|
19
|
||
PART
II. OTHER INFORMATION
|
||||
Item
1.
|
Legal
Proceedings
|
20
|
||
Item
1A.
|
Risk
Factors
|
20
|
||
Item
5.
|
Other
Information
|
20
|
||
Item
6.
|
Exhibits
|
21
|
||
SIGNATURES
|
|
22
|
i
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
NOVAVAX,
INC.
CONSOLIDATED
BALANCE SHEETS
(in
thousands, except share and per share information)
September 30,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 16,215 | $ | 38,757 | ||||
Short-term
investments available-for-sale
|
20,648 | 4,193 | ||||||
Accounts
and other receivables
|
599 | 258 | ||||||
Prepaid
expenses and other current assets
|
348 | 1,295 | ||||||
Total
current assets
|
37,810 | 44,503 | ||||||
Property
and equipment, net
|
8,203 | 7,801 | ||||||
Goodwill
|
33,141 | 33,141 | ||||||
Other
non-current assets
|
160 | 160 | ||||||
Total
assets
|
$ | 79,314 | $ | 85,605 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,350 | $ | 2,098 | ||||
Accrued
expenses and other current liabilities
|
5,761 | 5,417 | ||||||
Current
portion of notes payable
|
80 | 80 | ||||||
Deferred
revenue
|
7 | 150 | ||||||
Deferred
rent
|
330 | 282 | ||||||
Total
current liabilities
|
9,528 | 8,027 | ||||||
Non-current
portion of notes payable
|
340 | 406 | ||||||
Deferred
rent
|
2,453 | 2,707 | ||||||
Total
liabilities
|
12,321 | 11,140 | ||||||
Commitments
and contingences
|
— | — | ||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, $0.01 par value, 2,000,000 shares authorized; no shares issued and
outstanding
|
— | — | ||||||
Common
stock, $0.01 par value, 200,000,000 shares authorized; and 111,111,792
shares issued and 110,644,695 shares outstanding at September 30, 2010 and
100,717,890 shares issued and 100,262,460 shares outstanding at December
31, 2009
|
1,111 | 1,007 | ||||||
Additional
paid-in capital
|
374,384 | 350,810 | ||||||
Notes
receivable from former directors
|
(1,572 | ) | (1,572 | ) | ||||
Accumulated
deficit
|
(305,344 | ) | (274,150 | ) | ||||
Treasury
stock, 467,097 and 455,430 shares at September 30, 2010 and December 31,
2009, respectively, cost basis
|
(2,450 | ) | (2,450 | ) | ||||
Accumulated
other comprehensive income
|
864 | 820 | ||||||
Total
stockholders’ equity
|
66,993 | 74,465 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 79,314 | $ | 85,605 |
The
accompanying notes are an integral part of these consolidated financial
statements.
1
NOVAVAX,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except per share information)
(unaudited)
For the Three Months
Ended September 30,
|
For the Nine Months
Ended September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenue
|
$ | 175 | $ | 201 | $ | 292 | $ | 251 | ||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
7,870 | 5,256 | 23,226 | 14,819 | ||||||||||||
General
and administrative
|
2,844 | 3,207 | 8,528 | 8,661 | ||||||||||||
Total
operating expenses
|
10,714 | 8,463 | 31,754 | 23,480 | ||||||||||||
Loss
from operations
|
(10,539 | ) | (8,262 | ) | (31,462 | ) | (23,229 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
50 | 59 | 138 | 239 | ||||||||||||
Interest
expense
|
(2 | ) | (19 | ) | (6 | ) | (783 | ) | ||||||||
Other
income
|
136 | — | 136 | — | ||||||||||||
Impairment
of short-term investments
|
— | — | — | (1,338 | ) | |||||||||||
Realized
gains on short-term investments
|
— | 692 | — | 692 | ||||||||||||
Net
loss
|
$ | (10,355 | ) | $ | (7,530 | ) | $ | (31,194 | ) | $ | (24,419 | ) | ||||
Basic
and diluted net loss per share
|
$ | (0.10 | ) | $ | (0.08 | ) | $ | (0.30 | ) | $ | (0.30 | ) | ||||
Basic
and diluted weighted average number of common shares
outstanding
|
107,092 | 92,297 | 102,683 | 82,027 |
The
accompanying notes are an integral part of these consolidated financial
statements.
2
NOVAVAX,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
(unaudited)
For the Nine Months
Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
Activities:
|
||||||||
Net
loss:
|
$ | (31,194 | ) | $ | (24,419 | ) | ||
Reconciliation
of net loss to net cash used in operating activities:
|
||||||||
Depreciation
and amortization
|
991 | 899 | ||||||
Amortization
of debt discount
|
— | 147 | ||||||
Amortization
of deferred financing costs
|
— | 222 | ||||||
Amortization
of short-term investments premium (discount)
|
134 | — | ||||||
Loss
on disposal of property and equipment
|
32 | 28 | ||||||
Impairment
of property and equipment
|
127 | 21 | ||||||
Deferred
rent
|
(206 | ) | (207 | ) | ||||
Non-cash
stock-based compensation
|
1,141 | 1,270 | ||||||
Impairment
of short-term investments
|
— | 1,338 | ||||||
Realized
gains on short-term investments
|
— | (692 | ) | |||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
and other receivables
|
(341 | ) | 105 | |||||
Prepaid
expenses and other current assets
|
947 | 371 | ||||||
Accounts
payable and accrued expenses
|
1,468 | 272 | ||||||
Deferred
revenue
|
(143 | ) | 201 | |||||
Net
cash used in operating activities
|
(27,044 | ) | (20,444 | ) | ||||
Investing
Activities:
|
||||||||
Capital
expenditures
|
(1,424 | ) | (356 | ) | ||||
Proceeds
from disposal of property and equipment
|
— | 7 | ||||||
Proceeds
from maturities of short-term investments
|
11,000 | 2,575 | ||||||
Purchases
of short-term investments
|
(27,545 | ) | — | |||||
Net
cash (used in) provided by investing activities
|
(17,969 | ) | 2,226 | |||||
Financing
Activities:
|
||||||||
Principal
payments of notes payable
|
(66 | ) | (15,088 | ) | ||||
Net
proceeds from sales of common stock, net of offering costs of $0.4 million
and $1.0 million, respectively
|
22,114 | 35,560 | ||||||
Proceeds
from the exercise of stock options
|
423 | 792 | ||||||
Net
cash provided by financing activities
|
22,471 | 21,264 | ||||||
Net
(decrease) increase in cash and cash equivalents
|
(22,542 | ) | 3,046 | |||||
Cash
and cash equivalents at beginning of period
|
38,757 | 26,938 | ||||||
Cash
and cash equivalents at end of period
|
$ | 16,215 | $ | 29,984 | ||||
Supplemental
disclosure of non-cash activities:
|
||||||||
Equipment
purchases included in accounts payable
|
$ | 128 | $ | 5 | ||||
Payment
of notes payable through issuance of common stock
|
$ | — | $ | 7,660 | ||||
Supplemental
disclosure of cash flow information:
|
||||||||
Cash
interest payments
|
$ | — | $ | 879 |
The
accompanying notes are an integral part of these consolidated financial
statements.
3
NOVAVAX,
INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2010
Note
1 – Organization
Novavax,
Inc. (the “Company”), is a clinical-stage biopharmaceutical company focused on
developing novel, highly potent recombinant vaccines. These vaccines leverage
the Company’s virus-like-particle (“VLP”) platform technology coupled with a
unique disposable production technology. VLPs are genetically engineered
three-dimensional nanostructures, which incorporate immunologically important
lipids and recombinant proteins. The Company’s VLPs resemble a live virus, but
lack the genetic material to replicate the virus, and its proprietary production
technology uses insect cells rather than chicken eggs or mammalian cells. The
Company’s current product targets include vaccines against pandemic influenza
(including H5N1 pandemic strain), seasonal influenza, Respiratory Syncytial
Virus (“RSV”) and Varicella Zoster Virus (“VZV”), which causes
shingles.
In 2009,
the Company formed a joint venture (the “JV”) with Cadila Pharmaceuticals Ltd.
(“Cadila”) named CPL Biologicals Private Limited to develop and manufacture
vaccines, biological therapeutics and diagnostics in India. The Company owns 20%
of the JV, and Cadila owns the remaining 80%.
Note
2 – Liquidity Matters
Since its
inception, the Company has incurred, and continues to incur, significant losses
from operations. At September 30, 2010, the Company had cash and cash
equivalents of $16.2 million and short-term investments with a fair value of
$20.6 million. Since September 30, 2010 through November 5, 2010, the Company
has sold additional shares of common stock under its At Market Issuance Sales
Agreement, discussed below, at an average sales price of $2.20 per share,
resulting in $1.0 million in net proceeds.
The
Company’s vaccine candidates currently under development will require
significant additional research and development efforts, including extensive
pre-clinical and clinical testing, and regulatory approval, prior to commercial
use. The Company’s research and development efforts may not be successful and
any potential vaccine candidates may not prove to be safe and effective in
clinical trials. Even if developed, these vaccine candidates 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 is subject to significant risks including, but not limited to,
manufacturing scale-up and market acceptance.
Based on
the Company’s cash, cash equivalents and short-term investments balances as of
September 30, 2010, anticipated proceeds from sales of the Company’s common
stock under its At Market Issuance Sales Agreement with McNicoll, Lewis &
Vlak LLC (“MLV”) and its current business operations, the Company believes it
will have adequate capital resources available to operate at planned levels for
at least the next twelve months. Additional capital will be required in the
future to develop its vaccine candidates through clinical trials and
commercialization. The Company’s ability to raise funds under its At Market
Issuance Sales Agreement is subject to market conditions. Further, the Company
will seek additional capital through public or private equity offerings, debt
financing, strategic alliance and licensing arrangements, government contracts,
collaborative arrangements, or some combination of these financing alternatives.
Any capital raised by an equity offering, whether public or private, will likely
be substantially dilutive to the existing stockholders and any licensing or
development arrangement may require the Company to give up rights to a product
or technology at less than its full potential value. The Company has not secured
any additional commitments for new financing nor can the Company provide any
assurance the Company’s financing will be available on commercially acceptable
terms, if at all. If the Company is unable to obtain additional capital, it will
assess its capital resources and will likely be required to delay, reduce the
scope of, or eliminate one or more of its research and development programs,
and/or downsize the organization, including its general and administrative
infrastructure.
4
Note
3 – Summary of Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited consolidated financial statements have been prepared in
accordance with United States Generally Accepted Accounting Principles (“GAAP”)
for interim financial information and the instructions to Form 10-Q and Article
10 of Regulation S-X. The consolidated balance sheet as of September
30, 2010, consolidated statements of operations for the three and nine months
ended September 30, 2010 and 2009 and the consolidated statements of cash flows
for the nine months ended September 30, 2010 and 2009 are unaudited, but include
all adjustments (consisting of normal recurring adjustments) that the Company
considers necessary for a fair presentation of the financial position, operating
results and cash flows, respectively, for the periods
presented. Although the Company believes that the disclosures in
these financial statements are adequate to make the information presented not
misleading, certain information and footnote information normally included in
financial statements prepared in accordance with GAAP have been condensed or
omitted pursuant to the rules and regulations of the United States Securities
and Exchange Commission (“SEC”).
The
accompanying consolidated financial statements include the accounts of the
Company and its wholly owned subsidiary, Fielding Pharmaceutical Company. All
significant intercompany accounts and transactions have been eliminated in
consolidation.
Results
for any interim period are not necessarily indicative of results for any future
interim period or for the entire year. The accompanying unaudited
consolidated financial statements should be read in conjunction with the
consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2009.
Use
of Estimates
The
preparation of the consolidated financial statements in conformity with GAAP
requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of
revenue and expenses during the reporting period. Actual results could differ
materially from those estimates.
Fair
Value Measurements
ASC 820,
Fair Value Measurements and
Disclosures, discusses valuation techniques, such as the market approach
(comparable market prices), the income approach (present value of future income
or cash flow) and the cost approach (cost to replace the service capacity of an
asset or replacement cost). The statement utilizes a fair value hierarchy that
prioritizes the inputs to valuation techniques used to measure fair value into
three broad levels. The following is a brief description of those three
levels:
|
·
|
Level
1: Observable inputs such as quoted prices (unadjusted) in active markets
for identical assets or
liabilities.
|
|
·
|
Level
2: Inputs other than quoted prices that are observable for the asset or
liability, either directly or indirectly. These include quoted prices for
similar assets or liabilities in active markets and quoted prices for
identical or similar assets or liabilities in markets that are not
active.
|
|
·
|
Level
3: Unobservable inputs that reflect the reporting entity’s own
assumptions.
|
5
Financial
assets and liabilities measured at fair market value on a recurring basis as of
September 30, 2010 are summarized below (in thousands):
Fair Value Measurement at
September 30, 2010 using Fair Value Hierarchy
|
||||||||||||||||
Assets
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
||||||||||||
Cash
and cash equivalents
|
$ | 16,215 | $ | — | $ | — | $ | 16,215 | ||||||||
Short-term
investments
|
— | 20,648 | — | 20,648 | ||||||||||||
Total
|
$ | 16,215 | $ | 20,648 | $ | — | $ | 36,863 |
The
amounts in the Company’s consolidated balance sheet for accounts and other
receivables, accounts payable and notes payable approximate fair value due to
their short-term nature.
Short-Term
Investments
Short-term
investments at September 30, 2010 consist of investments in commercial paper,
corporate notes and three auction rate securities. The auction rate securities
have a par value of $5.1 million. The Company has classified these securities as
available-for-sale since the Company may need to liquidate these securities
within the next year. The available-for-sale securities are carried at fair
value and unrealized gains and losses, if determined to be temporary, on these
securities are included in accumulated other comprehensive income (loss) in
stockholders’ equity. Investments available for sale are evaluated periodically
to determine whether a decline in value is “other-than-temporary.” The term
“other-than-temporary” is not intended to indicate a permanent decline in value.
Rather, it means that the prospects for a near term recovery of value are not
necessarily favorable, or that there is a lack of evidence to support fair
values equal to, or greater than, the carrying value of the security. Management
reviews criteria, such as the magnitude and duration of the decline, as well as
the Company’s ability to hold the securities until market recovery, to predict
whether the loss in value is other-than-temporary. If a decline in value is
determined to be other-than-temporary, the value of the security is reduced and
the impairment is recorded in the consolidated statements of operations. The
specific identification method is used in computing realized gains and losses on
sale of the Company’s securities.
Short-term
investments classified as available-for-sale as of September 30, 2010 were
comprised of (in thousands):
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
|||||||||||||
Auction
rate securities
|
$ | 3,373 | $ | 862 | $ | — | $ | 4,235 | ||||||||
Corporate
debt securities
|
16,411 | 2 | — | 16,413 | ||||||||||||
Total
|
$ | 19,784 | $ | 864 | $ | — | $ | 20,648 |
Net
Loss per Share
Net loss
per share is computed using the weighted average number of shares of common
stock outstanding. All outstanding warrants, stock options and unvested
restricted stock awards totaling 9,761,587 shares and 9,671,366 shares at September 30,
2010 and 2009, respectively, are excluded from the computation, as their effect
is antidilutive.
Comprehensive
Income (Loss)
Comprehensive
income (loss) is the total net income (loss) plus all changes in equity during
the period except those changes resulting from investment by and distribution to
owners. Total comprehensive loss, including unrealized gains (losses) on the
Company’s available-for-sale investments, was $10.2 million and $7.4 million
for the three months ended September 30, 2010 and 2009, respectively. Total
comprehensive loss, including unrealized gains (losses) on the Company
available-for-sale investments, was $31.2 million and $23.8
million for the nine months ended September 30, 2010 and 2009,
respectively.
6
Recent
Accounting Pronouncements Not Yet Adopted
In
September 2009, ASU 2009-13, Revenue Recognition (Topic
605)—Multiple-Deliverable
Revenue Arrangements, was issued and will change the accounting for
multiple-deliverable arrangements to enable vendors to account for products or
services (deliverables) separately rather than as a combined
unit. Specifically, this guidance amends the criteria in Subtopic
605-25, Revenue
Recognition—Multiple-Element
Arrangements, for separating consideration in multiple-deliverable
arrangements. This guidance establishes a selling price hierarchy for
determining the selling price of a deliverable, which is based on:
(a) vendor-specific objective evidence; (b) third-party evidence; or
(c) estimates. This guidance also eliminates the residual method of
allocation and requires that arrangement consideration be allocated at the
inception of the arrangement to all deliverables using the relative selling
price method. In addition, this guidance significantly expands required
disclosures related to a vendor’s multiple-deliverable revenue arrangements. ASU
2009-13 is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010,
with early adoption permitted. The impact of ASU 2009-13 on the Company’s
consolidated financial statements will depend on the nature and terms of its
revenue arrangements entered into or materially modified after the adoption
date. However, based on the Company’s current customer arrangements, the Company
does not believe the adoption of this ASU will have a material impact on its
consolidated financial statements.
In
March 2010, ASU 2010-17, Revenue Recognition—Milestone Method
(Topic 605): Milestone
Method of Revenue Recognition—a consensus of the FASB Emerging Issues Task
Force, was issued and will amend the accounting for revenue arrangements
under which a vendor satisfies its performance obligations to a customer over a
period of time, when the deliverable or unit of accounting is not within the
scope of other authoritative literature and when the arrangement consideration
is contingent upon the achievement of a milestone. The amendment defines a
milestone and clarifies whether an entity may recognize consideration earned
from the achievement of a milestone in the period in which the milestone is
achieved. This amendment is effective on a prospective basis for milestones
achieved on or after January 1, 2011, with early adoption permitted. The
amendment may be applied retrospectively to all arrangements or prospectively
for milestones achieved after the effective date. The Company expects to
prospectively apply the amended guidance to milestones achieved on or after
January 1, 2011. The new guidance is consistent with the Company’s current
revenue recognition policies for arrangements with milestones. As a result, the
Company does not believe the adoption of this ASU will have a material impact on
its consolidated financial statements.
Note
4 – Stock-Based Compensation
Under the
Company’s stock-based compensation plan, the 2005 Stock Incentive Plan (the
“2005 Plan”), equity awards may be granted to officers, directors, employees,
consultants and advisors to the Company and any present or future
subsidiary. The 2005 Plan currently authorizes the grant of equity awards
for up to 11,312,192 shares of common stock, which included, at the time of
approval of the 2005 Plan, a maximum 5,746,468 shares of common stock subject to
stock options outstanding under the Company’s 1995 Stock Option Plan (the “1995
Plan”) that may revert to and become issuable under the 2005 Plan if such
options should expire or otherwise terminate unexercised. The term of the
Company’s previous stock-based compensation plan, the 1995 Plan, has expired.
Outstanding stock options remain in existence in accordance with their terms and
no new awards will be made under the 1995 Plan. The Company’s 1995 Director
Stock Option Plan (the “1995 Director Plan”) has expired, and no stock options
under this plan remain outstanding at September 30, 2010.
7
The
Company recorded stock-based compensation expense in the consolidated statements
of operations as follows (in thousands):
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Research
and development
|
$ | 207 | $ | 165 | $ | 215 | $ | 501 | ||||||||
General
and administrative
|
425 | 252 | 926 | 769 | ||||||||||||
Total
stock-based compensation expenses
|
$ | 632 | $ | 417 | $ | 1,141 | $ | 1,270 |
During
the three months ended March 31, 2010, the Company recorded a stock-based
compensation benefit of ($0.1) million due to the reversal of previously
recognized expense for unvested stock options that were cancelled due to
employees leaving the Company.
Stock
Options Awards
The
following is a summary of option activity under the 2005 Plan, the 1995 Plan and
the 1995 Director Plan for the nine months ended September 30,
2010:
2005 Stock Incentive
Plan
|
1995 Stock Option
Plan
|
1995 Director Stock
Option Plan
|
||||||||||||||||||||||
Stock
Options
|
Weighted-
Average
Exercise
Price
|
Stock
Options
|
Weighted-
Average
Exercise
Price
|
Stock
Options
|
Weighted-
Average
Exercise
Price
|
|||||||||||||||||||
Outstanding
at January 1, 2010
|
4,878,675 | $ | 2.38 | 1,086,319 | $ | 5.72 | 30,000 | $ | 5.63 | |||||||||||||||
Granted
|
1,877,250 | $ | 2.33 | — | $ | — | — | $ | — | |||||||||||||||
Exercised
|
(211,774 | ) | $ | 1.53 | (45,000 | ) | $ | 2.21 | — | $ | — | |||||||||||||
Canceled
|
(830,739 | ) | $ | 2.69 | (461,469 | ) | $ | 7.04 | (30,000 | ) | $ | 5.63 | ||||||||||||
Outstanding
at September 30, 2010
|
5,713,412 | $ | 2.35 | 579,850 | $ | 4.97 | — | $ | — | |||||||||||||||
Shares
exercisable at September 30, 2010
|
2,615,399 | $ | 2.32 | 579,850 | $ | 4.97 | — | $ | — | |||||||||||||||
Shares
available for grant at September 30, 2010
|
2,094,205 |
The fair
value of stock options granted was estimated at the date of grant using the
Black-Scholes option-pricing model with the following assumptions:
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||
Weighted-average
fair value of stock options
granted
|
$1.43
|
$2.60
|
$1.47
|
$1.25
|
||||||||
Risk-free
interest rate
|
1.11%-1.28%
|
1.57%-2.00%
|
1.11%-2.89%
|
1.56%-3.19%
|
||||||||
Dividend
yield
|
0%
|
0%
|
0%
|
0%
|
||||||||
Volatility
|
97.79%-105.26%
|
90.09%-90.33%
|
97.79%-108.02%
|
85.68%-111.83%
|
||||||||
Expected
life (in years)
|
3.34-4.47
|
3.89-4.02
|
3.06-6.26
|
3.89-7.05
|
||||||||
Expected
forfeiture rate
|
21.07%
|
21.07%
|
21.07%
|
21.07%-21.96%
|
The
aggregate intrinsic value and weighted-average remaining contractual term of
stock options outstanding as of September 30, 2010 was approximately $1.9
million and 7.1 years, respectively. The
aggregate intrinsic value and weighted-average remaining contractual term of
stock options exercisable as of September 30, 2010 was approximately $1.3 million and 5.6 years,
respectively. The aggregate intrinsic value represents the total intrinsic value
(the difference between the Company’s closing stock price on the last trading
day of the period and the exercise price, multiplied by the number of
in-the-money options) that would have been received by the option holders had
all option holders exercised their options on September 30, 2010. This amount is
subject to change based on changes to the fair value of the Company’s common
stock. The aggregate intrinsic value of options exercised for the nine months
ended September 30, 2010 and 2009 was $0.3 million and $0.8 million,
respectively.
8
Restricted
Stock Awards
Under the
2005 Plan, the Company has granted restricted stock awards subject to certain
performance-based and time-based vesting conditions which, if not met, would
result in forfeiture of the shares and reversal of any previously recognized
related stock-based compensation expense.
The
following is a summary of restricted stock awards activity for the nine months
ended September 30, 2010:
Number of
Shares
|
Per Share
Weighted-Average
Grant-Date
Fair Value
|
|||||||
Outstanding
at January 1, 2010
|
90,000 | $ | 3.04 | |||||
Restricted
stock granted
|
75,000 | $ | 2.20 | |||||
Restricted
stock vested
|
(28,333 | ) | $ | 2.77 | ||||
Restricted
stock forfeited
|
(11,667 | ) | $ | 2.77 | ||||
Outstanding
at September 30, 2010
|
125,000 | $ | 2.62 |
As of
September 30, 2010, there was approximately $3.0 million of total
unrecognized compensation expense (net of estimated forfeitures) related to
unvested options and restricted stock awards. This unrecognized compensation
expense is expected to be recognized over a weighted-average period of 1.6 years. This estimate
does not include the impact of other possible stock-based awards that may be
made during future periods.
Note
5 – At Market Issuance Sales Agreement
On March
15, 2010, the Company terminated its previous At Market Issuance Sales
Agreements entered into in 2009 with Wm Smith & Co. and entered into a new
sales agreement with MLV, as sales agent, under which the Company may sell an
aggregate of $50 million in gross proceeds of its common stock. The Company’s
Board of Directors has authorized the sale of up to 25 million shares of the
Company’s common stock pursuant to this agreement. The shares of common stock
are being offered pursuant to a shelf registration statement filed with the SEC.
Through September 30, 2010, the Company sold 10.1 million shares at an average
sales price of $2.24 per share, resulting in $22.1 million in net proceeds.
Since September 30, 2010 through November 5, 2010, the Company has sold an
additional 0.5 million shares at an
average sales price of $2.20 per share, resulting in $1.0 million in net
proceeds.
Note
6 – Related Party Transactions
Mr.
Lambert, a current member of the Company’s Board of Directors and its former
Executive Director, had a consulting agreement with the Company, pursuant to
which he assisted the Company with issues regarding the development and
commercialization of its vaccine candidates and assisted with business
development predominantly in the international markets. On March 8, 2010, Mr.
Lambert’s consulting agreement expired by its original terms. During
the three months ended March 31, 2010, the Company incurred an expense of
$41,398 for these services. In June 2010, the Company entered into a
new consulting agreement with Mr. Lambert, pursuant to which, as of April 1,
2010 and concluding on September 23, 2010, he acted as a Novavax representative
on the board of directors of CPL Biologicals Private Limited. During the nine
months ended September 30, 2010, the Company incurred $17,250 for these
services, which was reimbursed by the JV.
9
The
Company’s activities relating to the JV during the nine months ended September
30, 2010 consisted of the purchase by the Company of laboratory equipment for
$0.2 million and the reimbursement by the JV of travel and administrative costs
and services provided to the JV totaling $0.1 million. The reimbursement of
these costs and services are recorded as a reduction to operating
expenses.
Note
7 – Subsequent Events
The
Company evaluated its September 30, 2010 financial statements for subsequent
events through the date the financial statements were issued. In July 2010, the
Company submitted its applications for qualifying therapeutic discovery project
credits under §48D of the Internal Revenue Code, as amended (the “Code”), as
added to the Code by section 9023(a) of the Patient Protection and Affordable
Care Act of 2010. In October 2010, the Company was awarded grants totaling
$1.0 million
related to it applications.
10
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
Certain
statements contained or incorporated by reference herein constitute
forward-looking statements. In some cases, these statements can be identified by
the use of forward-looking terminology 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. Such forward-looking statements are
subject to risks and uncertainties that 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. We refer you to Item 1A Risk Factors in this Quarterly Report, as
well as in our Annual Report on Form 10-K for the year ended December 31, 2009,
which we incorporate herein by reference, for identification of important
factors with respect to risks and uncertainties.
Forward-looking
statements in this Quarterly Report include, without limitation, statements
regarding:
|
·
|
our
expectation that we will have adequate capital resources available to
operate at planned levels for at least the next twelve
months;
|
|
·
|
our
expectations for future funding requirements and capital raising activity,
including anticipated proceeds from our At Market Issuance Sales Agreement
with MLV;
|
|
·
|
our
expectations on financial or business performance, conditions or
strategies and other financial and business matters, including
expectations regarding operating expenses, use of cash, and the
fluctuations in expenses and capital requirements associated with
pre-clinical studies, clinical trials and other research and development
activities;
|
|
·
|
our
expectations on clinical development and anticipated milestones, including
a Department of Health and Human Services (HHS), Biomedical Advanced
Research and Development Authority (BARDA)
contract;
|
|
·
|
our
expectations that our trivalent seasonal influenza VLP vaccine could
potentially address an unmet medical need in older
adults;
|
|
·
|
our
expectations for the use of results from our clinical trial in Mexico to
support the development of vaccines in other countries, including the
United States;
|
|
·
|
our
expectations for the use of pre-clinical safety and efficacy studies to
support an RSV Investigational New Drug (IND)
application;
|
|
·
|
the
impact of new accounting pronouncements;
and
|
|
·
|
our
expectations concerning payments under existing license
agreements.
|
Factors
that may cause actual results to differ materially from the results discussed in
the forward-looking statements or historical experience include, among others,
the following:
|
·
|
our
ability to progress any vaccine candidates into pre-clinical studies 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
with positive data from pre-clinical studies or clinical trials, the
vaccine candidate may not prove to be safe and
efficacious;
|
|
·
|
decisions
by regulatory agencies may delay or prevent our development programs or
increase the costs of such
programs;
|
|
·
|
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;
|
|
·
|
RSV
is a difficult disease to prevent and there is significant activity by
many companies toward the development of a suitable
vaccine;
|
|
·
|
we
have not manufactured any of our vaccine candidates at a commercial
level;
|
11
|
·
|
we
utilize a unique manufacturing process and the scale-up of that process
may prove difficult and/or costly;
|
|
·
|
our
dependence on third parties to manufacture and distribute our
vaccines;
|
|
·
|
risks
associated with conducting business outside of the United
States;
|
|
·
|
the
cost and our ability of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property
rights;
|
|
·
|
competition
for clinical resources and patient enrollment from drug candidates in
development by other companies with greater resources and
visibility;
|
|
·
|
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
financings or otherwise;
|
|
·
|
our
ability to win any government contracts/grants, including from HHS BARDA,
in a timely manner or at all; and
|
|
·
|
other
factors referenced herein.
|
The
Company assumes no obligation to update any such forward-looking statements,
except as specifically required by law. We caution readers not to place
considerable reliance on the forward-looking statements contained in this
Quarterly Report.
Overview
Novavax,
Inc., a Delaware corporation (“Novavax,” the “Company,” “we,” or “us”), was
incorporated in 1987, and is a clinical-stage biopharmaceutical company focused
on developing novel, highly potent recombinant vaccines. These vaccines leverage
our virus-like-particle (VLP) platform technology coupled with a unique
disposable production technology.
VLPs are
genetically engineered three-dimensional nanostructures, which incorporate
immunologically important lipids and recombinant proteins. Our VLPs resemble a
live virus, but lack the genetic material to replicate the virus and our
proprietary production technology uses insect cells rather than chicken eggs or
mammalian cells. Our current product targets include vaccines against pandemic
influenza (including the H5N1 pandemic strain), seasonal influenza, Respiratory
Syncytial Virus (RSV) and Varicella Zoster Virus (VZV), which causes
shingles.
We have
completed a two-stage clinical trial of our 2009 H1N1 influenza VLP vaccine in
Mexico in collaboration with Laboratorio Avi-mex S.A. de C.V. and GE Healthcare.
The randomized blinded, placebo-controlled clinical trial was designed to
evaluate the safety and immunogenicity of our 2009 H1N1 influenza VLP vaccine in
healthy adults. We completed enrollment of the first stage and reported positive
results on the vaccine’s safety and immunogenicity in the first 1,000 subjects.
Due to the favorable results from the first stage, we initiated the second stage
of the trial to evaluate the safety of the vaccine in a larger cohort and
completed enrollment of more than 3,500 subjects. The 6-month safety evaluation
of the subjects in the second stage of the clinical trial was completed in
September 2010 and no vaccine-related serious adverse events were reported. The
final Clinical Study Report (CSR) is expected to be completed by the end of
2010. These results are expected to support development of our pandemic and
seasonal influenza VLP vaccines in other countries, including the United
States.
In March
2010, we released final results of the Phase II trial in healthy adults
immunized with our trivalent seasonal influenza VLP vaccine, for which we
completed enrollment in May 2009. The results showed the vaccine was
well-tolerated and immunogenic.
In April
2010, we reported the results of the Phase II trial in older adults (60 years or
higher in age) in a dose-ranging study comparing our trivalent seasonal
influenza VLP vaccine with a commercially available inactivated trivalent
influenza vaccine (TIV), for which we completed enrollment in November 2009. Our
report indicated that the vaccine was both safe and immunogenic against the
2009-2010 seasonal influenza virus strains in older adults. The Center for
Disease Control and Prevention (CDC) has indicated that currently approved
seasonal influenza vaccines have shown to be only 30% to 70% effective in
preventing hospitalization for pneumonia and influenza in older adults; however,
we believe that our trivalent seasonal influenza VLP vaccine has the potential
to address this unmet medical need.
12
We have
also developed vaccine candidates for both RSV and VZV. We completed a
pre-clinical safety and efficacy study of our RSV vaccine in cotton rats; the
results of which were used to support an Investigational New Drug application
that we filed with the FDA in September 2010. We received a specific question
from the FDA around our chemistry, manufacturing and controls (CMC) that caused
the agency to put our planned Phase I trial on clinical hold. We expect to
receive the FDA's written communication detailing their concerns by the middle
of November 2010. We plan to work with the FDA to address these questions so
that we can continue to move ahead with our Phase I trial as soon as
possible.
We
submitted our proposal in September 2009 in response to United States Government
RFP solicitation number HHS BARDA-09-32 for the advanced development of
recombinant influenza vaccines in a U.S.-based manufacturing facility. In April
2010, HHS BARDA determined that our proposal to provide recombinant influenza
vaccines and manufacturing capabilities for pandemic preparedness was in the
competitive range for award of an advanced development contract. In September
2010, in response to a request from HHS BARDA, we submitted our Final Proposal
Revision (FPR) and currently await a determination by HHS BARDA.
Our
vaccine candidates currently under development will require significant
additional research and development efforts, including extensive pre-clinical
and clinical testing, and regulatory approval, prior to commercial use. Our
research and development efforts may not be successful and any potential vaccine
candidates may not prove to be safe and effective in clinical trials. Even if
developed, these vaccine candidates may not receive regulatory
approval or be successfully introduced and marketed at prices that would permit
us to operate profitably. The commercial launch of any vaccine is subject to
significant risks including, but not limited to, manufacturing scale-up and
market acceptance. We may not generate sufficient product revenue to become
profitable or generate positive cash flow. We continue to fund our operations
through the sales of our common stock. We terminated our previous At Market
Issuance Sales Agreements entered into in 2009 with Wm Smith & Co. and
entered into a new sales agreement with McNicoll, Lewis & Vlak LLC (“MLV”),
as sales agent, under which we may sell an aggregate of $50 million. Our Board
of Directors has authorized the sale of up to 25 million shares of our common
stock pursuant to this agreement. Since entering into the agreement with MLV on
March 15, 2010 and through November 5, 2010, we have sold 10.5 million shares of our
common stock for aggregate net proceeds of $23.1 million.
Recent
Accounting Pronouncements Not Yet
Adopted
In
September 2009, ASU 2009-13, Revenue Recognition (Topic
605)—Multiple-Deliverable
Revenue Arrangements, was issued and will change the accounting for
multiple-deliverable arrangements to enable vendors to account for products or
services (deliverables) separately rather than as a combined unit. Specifically,
this guidance amends the criteria in Subtopic 605-25, Revenue Recognition—Multiple-Element
Arrangements, for separating consideration in multiple-deliverable
arrangements. This guidance establishes a selling price hierarchy for
determining the selling price of a deliverable, which is based on:
(a) vendor-specific objective evidence; (b) third-party evidence; or
(c) estimates. This guidance also eliminates the residual method of
allocation and requires that arrangement consideration be allocated at the
inception of the arrangement to all deliverables using the relative selling
price method. In addition, this guidance significantly expands required
disclosures related to a vendor’s multiple-deliverable revenue arrangements. ASU
2009-13 is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010,
with early adoption permitted. The impact of ASU 2009-13 on our consolidated
financial statements will depend on the nature and terms of our revenue
arrangements entered into or materially modified after the adoption date.
However, based on our current customer arrangements, we do not believe the
adoption of this ASU will have a material impact on our consolidated financial
statements.
13
In
March 2010, ASU 2010-17, Revenue Recognition—Milestone Method
(Topic 605): Milestone
Method of Revenue Recognition—a consensus of the FASB Emerging Issues Task
Force, was issued and will amend the accounting for revenue arrangements
under which a vendor satisfies its performance obligations to a customer over a
period of time, when the deliverable or unit of accounting is not within the
scope of other authoritative literature and when the arrangement consideration
is contingent upon the achievement of a milestone. The amendment defines a
milestone and clarifies whether an entity may recognize consideration earned
from the achievement of a milestone in the period in which the milestone is
achieved. This amendment is effective on a prospective basis for milestones
achieved on or after January 1, 2011, with early adoption permitted. The
amendment may be applied retrospectively to all arrangements or prospectively
for milestones achieved after the effective date. We expect to prospectively
apply the amended guidance to milestones achieved on or after January 1, 2011.
The new guidance is consistent with our current revenue recognition policies for
arrangements with milestones. As a result, we do not believe the adoption of
this ASU will have a material impact on our consolidated financial
statements.
Results
of Operations
The
following is a discussion of the historical consolidated financial condition and
results of operations of the Company and its wholly owned subsidiary and should
be read in conjunction with the consolidated financial statements and notes
thereto set forth in this Quarterly Report.
Three Months Ended September 30, 2010
and 2009 (amounts in tables are presented in thousands, except per share
information)
Revenue:
Three Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Revenue:
|
||||||||||||
Total
revenue
|
$ | 175 | $ | 201 | $ | (26 | ) |
Revenue
for the three months ended September 30, 2010 and 2009 was $0.2 million. Revenue is
comprised primarily of services performed under contracts with United States
government agencies.
Operating
Expenses:
Three Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Operating
Expenses:
|
||||||||||||
Research
and development
|
$ | 7,870 | $ | 5,256 | $ | 2,614 | ||||||
General
and administrative
|
2,844 | 3,207 | (363 | ) | ||||||||
Total
operating expenses
|
$ | 10,714 | $ | 8,463 | $ | 2,251 |
Research
and Development Expenses
Research
and development expenses increased to $7.9 million for the three
months ended September 30, 2010 from $5.3 million for the same period in 2009,
an increase of $2.6 million, or 50%, primarily due to higher
research and development spending to support our clinical trials related to our
H1N1 and seasonal influenza vaccine candidates. The increase is primarily a
result of increased employee and outside-testing costs (including outsourced
clinical trial costs, sponsored research
and consulting agreements).
14
General and
Administrative Expenses
General
and administrative expenses decreased to $2.8 million for the three months ended
September 30, 2010 from $3.2 million for the same period in 2009, a decrease of
$0.4 million, or 11%, primarily due to lower professional service fees.
Other Income
(Expense):
Three Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Other
Income (Expense):
|
||||||||||||
Interest
income
|
$ | 50 | $ | 59 | $ | (9 | ) | |||||
Interest
expense
|
(2 | ) | (19 | ) | 17 | |||||||
Other income
|
136 | — | 136 | |||||||||
Gains
on short-term investments
|
— | 692 | (692 | ) | ||||||||
Total
other income (expense)
|
$ | 184 | $ | 732 | $ | (548 | ) |
We had
total other income of $0.2 million for the three months ended September 30, 2010
compared to total other income of $0.7 million for the same period in 2009, a
change of $0.5 million. In the three months ended September 30, 2009, we
recorded a gain of $0.7 million relating to redemptions of several of our
auction rate securities.
Net
Loss:
Three Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Net
Loss:
|
||||||||||||
Net
loss
|
$ | (10,355 | ) | $ | (7,530 | ) | $ | (2,825 | ) | |||
Net
loss per share
|
$ | (0.10 | ) | $ | (0.08 | ) | $ | 0.02 | ||||
Weighted
shares outstanding
|
107,092 | 92,297 | 14,795 |
Net loss
for the three months ended September 30, 2010 was $10.4 million, or $0.10 per share, as compared
to $7.5 million, or $0.08 per share, for the same period in 2009, an increased
net loss of $2.9 million. The increased
net loss was primarily due to higher research and development spending to
support our clinical trials related to our H1N1 and seasonal influenza vaccine
candidates in the three months ended September 30, 2010.
The
increase in weighted shares outstanding for the three months ended September 30,
2010 is primarily a result of sales of our common stock through an underwritten
public offering and under our At Market Issuance Sales
Agreements.
15
Nine Months Ended September 30, 2010
and 2009 (amounts in tables are presented in thousands, except per share
information)
Revenue:
Nine Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Revenue:
|
||||||||||||
Total
revenue
|
$ | 292 | $ | 251 | $ | 41 |
Revenue
for the nine months ended September 30, 2010 and 2009 was $0.3 million. Revenue is
comprised primarily of services performed under contracts with United States
government agencies.
Operating
Expenses:
Nine Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Operating
Expenses:
|
||||||||||||
Research
and development
|
$ | 23,226 | $ | 14,819 | $ | 8,407 | ||||||
General
and administrative
|
8,528 | 8,661 | (133 | ) | ||||||||
Total
operating expenses
|
$ | 31,754 | $ | 23,480 | $ | 8,274 |
Research
and Development Expenses
Research
and development expenses increased to $23.2 million for nine months
ended September 30, 2010 from $14.8 million for the same period in 2009, an
increase of $8.4 million, or 57%,
primarily due to higher research and development spending to support our
clinical trials related to our H1N1 and seasonal influenza vaccine candidates.
The increase is primarily a result of increased employee and outside-testing
costs (including outsourced clinical trial costs, sponsored research
and consulting agreements).
General and
Administrative Expenses
General
and administrative expenses were relatively unchanged at $8.5 million for the nine
months ended September 30, 2010 as compared to $8.7 million for the same period
in 2009.
Other Income
(Expense):
Nine Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Other
Income (Expense):
|
||||||||||||
Interest
income
|
$ | 138 | $ | 239 | $ | (101 | ) | |||||
Interest
expense
|
(6 | ) | (783 | ) | 777 | |||||||
Other income
|
136 | — | 136 | |||||||||
Impairment
of short-term investments
|
— | (1,338 | ) | 1,338 | ||||||||
Gains
on short-term investments
|
— | 692 | (692 | ) | ||||||||
Total
other income (expense)
|
$ | 268 | $ | (1,190 | ) | $ | 1,458 |
16
We had
total other income of $0.3 million for the nine months ended September 30, 2010
compared to total other expense of $1.2 million for the same period in 2009, a
change of $1.5 million. Interest expense decreased $0.8 million to less than
$0.1 million for the nine months ended September 30, 2010 from $0.8 million for
the same period in 2009 as a result of the payment of our convertible notes in
2009. In the nine months ended September 30, 2009, we recorded an impairment of
$1.3 million relating to our auction rate securities, which was partially offset
by realized gains of $0.7 million relating to redemptions of several auction
rate securities.
Net
Loss:
Nine Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Net
Loss:
|
||||||||||||
Net
loss
|
$ | (31,194 | ) | $ | (24,419 | ) | $ | (6,775 | ) | |||
Net
loss per share
|
$ | (0.30 | ) | $ | (0.30 | ) | $ | — | ||||
Weighted
shares outstanding
|
102,683 | 82,027 | 20,656 |
Net loss
for the nine months ended September 30, 2010 was $31.2 million, or $0.30 per share, as compared
to $24.4 million, or $0.30 per share, for the same period in 2009, an increased
net loss of $6.8 million. The increased
net loss was primarily due to higher research and development spending to
support our clinical trials related to our H1N1 and seasonal influenza vaccine
candidates.
The
increase in weighted shares outstanding for the nine months ended September 30,
2010 is primarily a result of sales of our common stock through direct stock
offerings, in an underwritten public offering and under our At Market Issuance
Sales Agreements.
Liquidity
Matters and Capital Resources
Our
future capital requirements depend on numerous factors including, but not
limited to, the commitments and progress of our research and development
programs, the progress of pre-clinical and clinical testing, the time and costs
involved in obtaining regulatory approvals, the costs of filing, prosecuting,
defending and enforcing patent claims and other intellectual property rights and
manufacturing costs. We plan to continue to have multiple vaccine candidates in
various stages of development, and we believe our research and development, as
well as general and administrative expenses and capital requirements will
fluctuate depending upon the timing, scope and progress of our pre-clinical
studies and clinical trials and other research and development
activities.
As of
September 30, 2010, we had $16.2 million in cash and cash equivalents and $20.6
million in short-term investments as compared to $38.8 million and $4.2 million,
respectively, at December 31, 2009. The following table summarizes cash flows
for the nine months ended September 30, 2010 and 2009 (in
thousands):
Nine Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change 2009
to 2010
|
||||||||||
Summary of Cash
Flows:
|
||||||||||||
Net
cash (used in) provided by:
|
||||||||||||
Operating
activities
|
$ | (27,044 | ) | $ | (20,444 | ) | $ | (6,600 | ) | |||
Investing
activities
|
(17,969 | ) | 2,226 | (20,195 | ) | |||||||
Financing
activities
|
22,471 | 21,264 | 1,207 | |||||||||
Net
(decrease) increase in cash and cash equivalents
|
(22,542 | ) | 3,046 | (25,588 | ) | |||||||
Cash
and cash equivalents at beginning of period
|
38,757 | 26,938 | 11,819 | |||||||||
Cash
and cash equivalents at end of period
|
$ | 16,215 | $ | 29,984 | $ | (13,769 | ) |
17
Net cash
used in operating activities increased to $27.0 million for the nine
months ended September 30, 2010 from $20.4 million for the same period in
2009, primarily due to our increased loss, resulting primarily from our higher
research and development spending to support our clinical trials related to our
H1N1 and seasonal influenza vaccine candidates.
During
the nine months ended September 30, 2010 and 2009, our investing activities
consisted primarily of purchases and maturities of short-term investments and
capital expenditures. Capital expenditures for the nine months ended September
30, 2010 and 2009 were $1.4 million and $0.4
million, respectively. The increase in capital expenditures was primarily due to
the purchase of laboratory equipment relating to our manufacturing scale-up. We
purchased short-term investments in the nine months ended September 30, 2010 to
increase our rate of return on our funds. For 2010, as compared to 2009, we
expect our level of capital expenditures to increase modestly.
During
the nine months ended September 30, 2010, our financing activity consisted
primarily of $22.1 million in net proceeds from the sale of our common stock
pursuant to our At Market Issuance Sales Agreement with MLV. During the same
period in 2009, our financing activity consisted primarily of $35.6 million in
net proceeds from sale of our common stock pursuant to stock purchase agreements
and our previous At Market Issuance Sales Agreement that was subsequently
terminated, partially offset by payments of our convertible notes. We continue to sell our
common stock under our current At Market Issuance Sales Agreement with MLV and
since September 30, 2010 through November 5, 2010, we have sold an additional
0.5 million shares
for $1.0 million in
net proceeds.
We have
entered into agreements with outside clinical research organization providers to
support our clinical development. As of September 30, 2010, $4.8 million remains unpaid
on certain of these agreements in the event our outside providers complete their
services in 2010. However, under the terms of the agreements, we have the option
to terminate, but we would be obligated to pay the provider(s) for all costs
incurred through the effective date of termination.
We have
licensed certain rights from Wyeth Holdings Corporation (Wyeth) and the
University of Massachusetts Medical School (UMMS). The Wyeth license, which
provides for an upfront payment, annual license fees, milestone payments and
royalties on any product sales, 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 license may be terminated by Wyeth only for cause
and may be terminated by us only after we have provided ninety (90) days notice
that we have absolutely and finally ceased activity, including through any
affiliate or sublicense, related to the manufacturing, development, marketing or
sale of products covered by the license. In May 2010, we amended the license,
effective as of March 17, 2010, under which the parties agreed that we would not
be obligated to make a milestone payment in the event our H1N1 vaccine candidate
received regulatory approval in the country of Mexico, provided that we increase
certain subsequent milestone payments. Payments under the agreement to Wyeth
from 2007 through September 30, 2010 aggregated $5.1 million. We do not
expect to make a milestone payment to Wyeth in the next twelve months. The UMMS
license, which provides for milestone payments and royalties on product sales,
is an exclusive worldwide license of VLP technology to develop VLP vaccines for
the prevention of any viral diseases in humans. As of September 30, 2010, our
payments made to UMMS in the aggregate are not material. Also, we believe that
all payments under the UMMS agreement will not be material in the next twelve
months.
Based on
our cash, cash equivalents and short-term investments balances as of September
30, 2010, anticipated proceeds from the sale of our common stock under our At
Market Issuance Sales Agreement and our current business operations, we believe
we will have adequate capital resources available to operate at planned levels
for at least the next twelve months. Additional capital will be required in the
future to develop our vaccine candidates through clinical trials and
commercialization. Our ability to raise funds under our At Market Issuance Sales
Agreement is subject to market conditions. Further, we will seek additional
capital through public or private equity offerings, debt financing, strategic
alliance and licensing arrangements, government contracts, collaborative
arrangements, or some combination of these financing alternatives. Any capital
raised by an equity offering will likely be substantially dilutive to the
existing stockholders and any licensing or development arrangement may require
us to give up rights to a product or technology at less than its full potential
value. We have not secured any additional commitments for new financing nor can
we provide any assurance our financing will be available on commercially
acceptable terms, if at all. If we are unable to obtain additional capital, we
will assess our capital resources and will likely be required to delay, reduce
the scope of, or eliminate one or more of our research and development programs,
and/or downsize our organization, including our general and administrative
infrastructure.
18
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk
|
The
primary objective of our investment activities is to preserve our capital until
it is required to fund operations while at the same time maximizing the income
we receive from our investments without significantly increasing risk. As of
September 30, 2010, we had cash and cash equivalents of $16.2 million,
short-term investments of $20.6 million and working capital of $28.3 million.
Our
exposure to market risk is primarily confined to our investment portfolio. As of
September 30, 2010, our short-term investments are classified as
available-for-sale. We do not believe that a change in the market rates of
interest would have significant impact on the realizable value of our investment
portfolio. Changes in interest rates may affect the investment income we earn on
our investments and, therefore, could impact our cash flows and results of
operations.
Short-term
investments at September 30, 2010 consist of investments in commercial paper,
corporate notes and auction rate securities. We had previously invested in
auction rate securities for short periods of time as part of our cash management
program. The auction rate securities have a par value of $5.1 million and a fair
value of $4.2 million. In 2009, we recorded an other-than-temporary impairment
charge of $1.3 million related to these securities, which was partially offset
by realized gains of $0.8 million relating to redemptions of several auction
rate securities. At September 30, 2010, we have $0.9 million in unrealized gains
on the auction rate securities in accumulated other comprehensive income on the
consolidated balance sheet. These investments are classified within current
assets because we may need to liquidate these securities within the next year to
fund our ongoing operations.
Interest
and dividend income is recorded when earned and included in interest income.
Premiums and discounts, if any, on short-term investments are amortized or
accreted to maturity and included in interest income. The specific
identification method is used in computing realized gains and losses on sale of
securities.
Item 4.
|
Controls
and Procedures
|
Evaluation
of Disclosure Controls and Procedures
Our
management, with the assistance of our Chief Executive Officer and Chief
Financial Officer, has reviewed and evaluated the effectiveness of our
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended) as of September 30, 2010.
Management recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in evaluating the
cost-benefit relationship of possible controls and procedures. Our disclosure
controls and procedures are designed to provide reasonable assurance of
achieving their control objectives. Based on the evaluation of our disclosure
controls and procedures as of September 30, 2010, our Chief Executive Officer
and Chief Financial Officer concluded that, as of such date, our disclosure
controls and procedures were effective.
19
Changes
in Internal Control over Financial Reporting
Our
management, including our Chief Executive Officer and Chief Financial Officer,
has evaluated any changes in our internal control over financial reporting that
occurred during the third quarter of 2010, and has concluded that there was no
change that occurred during the third quarter of 2010 that materially affected,
or is reasonably likely to materially affect, our internal control over
financial reporting.
PART
II. OTHER INFORMATION
Item 1.
Legal Proceedings
Since
March 2010, when we initiated legal proceedings against Mr. Mitch Kelly in the
state of New York and Dr. Denis O’Donnell in the Commonwealth of Massachusetts
for collection of their respective indebtedness due to the Company, we have been
actively pursuing these lawsuits and attending to pretrial matters. Mr. Kelly
and Dr. O’Donnell are former directors of the Company that have each defaulted
on outstanding notes due to the Company in the aggregate principal amount of
$1,572,000. Preliminary discovery has been conducted on these matters and,
subject to each State court’s schedule, we plan to go to trial on these matters
in 2011.
Item 1A.
Risk Factors
There are
no material changes to the Company’s risk factors as described in Item 1A
of the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2009, as filed with the SEC, other than as mentioned
below.
We
may not be awarded a contract with HHS BARDA.
Although
we have been notified by HHS BARDA that our response to United States Government
RFP solicitation number HHS BARDA-09-32 for a contract award for the advanced
development of recombinant influenza vaccines is within the competitive range
for award consideration, and have submitted a Final Proposal Revision (FPR), we
may not win a contract with HHS BARDA. A contract with HHS BARDA would also be
attractive to our competitors, so we anticipate there to be significant
competition in the competitive range for this contract, potentially from
companies that have more experience, capital and human resources and overall
capabilities than we do. In addition, HHS BARDA may elect to limit a contract or
to not award any contract to us for a number of potential reasons including, but
not limited to, concerns resulting from unsatisfactory on-site inspections or
subsequent technical or business discussions; safety or efficacy issues not seen
to date may be encountered before HHS BARDA makes its decision; we have not yet
manufactured, or relied on third parties to manufacture, any vaccines at a
commercial scale; and HHS BARDA may elect to contract with multiple companies
that may or may not include us, and even if we were included in a contract, the
amount of the contract could be comparatively smaller than we currently
anticipate. Even if we were awarded the contract with HHS BARDA for a
comparatively larger amount, such a contract is unlikely to fully address our
liquidity issues.
Item 5.
Other Information
None.
20
Item 6.
Exhibits
Exhibits
marked with a single asterisk (*) are filed herewith.
31.1*
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the
Securities Exchange Act
|
|
31.2*
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the
Securities Exchange Act
|
|
32.1*
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
32.2*
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
21
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
NOVAVAX,
INC.
|
||
Date:
November 8, 2010
|
By:
|
/s/ Rahul Singhvi
|
President
and Chief Executive Officer
|
||
and
Director
|
||
(Principal
Executive Officer)
|
||
Date:
November 8, 2010
|
By:
|
/s/ Frederick W.
Driscoll
|
Vice
President, Chief Financial Officer
|
||
and
Treasurer
|
||
(Principal
Financial and Accounting
Officer)
|
22