x
|
QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
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)
|
Large accelerated
filer ¨
|
Accelerated
filer x
|
Non-accelerated
filer ¨
|
Smaller reporting
company ¨
|
(Do
not check if a smaller reporting
company)
|
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
|
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 |
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 |
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 |
|
·
|
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.
|
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 |
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 |
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 |
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 |
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%
|
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 |
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
·
|
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.
|
|
·
|
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;
|
|
·
|
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.
|
Three Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Revenue:
|
||||||||||||
Total
revenue
|
$ | 175 | $ | 201 | $ | (26 | ) |
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 |
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 | ) |
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 |
Nine Months Ended
September 30,
|
||||||||||||
2010
|
2009
|
Change
2009 to
2010
|
||||||||||
Revenue:
|
||||||||||||
Total
revenue
|
$ | 292 | $ | 251 | $ | 41 |
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 |
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 |
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 |
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 | ) |
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk
|
Item 4.
|
Controls
and Procedures
|
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
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32.2*
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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
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NOVAVAX,
INC.
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||
Date:
November 8, 2010
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By:
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/s/ Rahul Singhvi
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President
and Chief Executive Officer
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and
Director
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(Principal
Executive Officer)
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Date:
November 8, 2010
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By:
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/s/ Frederick W.
Driscoll
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Vice
President, Chief Financial Officer
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||
and
Treasurer
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||
(Principal
Financial and Accounting
Officer)
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