Attached files
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| 8-K - NOVAVAX INC | v192705_8k.htm |
| EX-99.2 - NOVAVAX INC | v192705_ex99-2.htm |
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Contact:
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Frederick
W. Driscoll
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VP, Chief
Financial Officer and Treasurer
Novavax,
Inc.
1-240-268-2000
NOVAVAX
REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
Rockville,
MD – August 6, 2010 – Novavax, Inc. (NASDAQ: NVAX) today announced financial
results for the second quarter ended June 30, 2010.
Novavax
reported a net loss of $9.4 million, or $0.09 per share, for the second
quarter of 2010 compared to a net loss of $8.5 million, or $0.10 per share, for
the second quarter of 2009. For the six months ended June 30,
2010, the net loss was $20.8 million, or $0.21 per share, compared to a net
loss of $16.9 million, or $0.22 per share, for the same period in
2009. The primary reason for the increased loss for the second
quarter of 2010 as compared to the same period in 2009 was higher research and
development spending to support the company’s clinical trials related to its
H1N1 and seasonal influenza vaccine candidates, as well as increased general and
administrative expenses relating to employee costs. Research and
development expenses for the second quarter of 2010 were $6.3 million as
compared to $5.3 million in the same period in 2009. General and
administrative expenses were $3.1 million for the second quarter of 2010 as
compared to $2.6 million in the same period in 2009.
As of June 30, 2010, the company
had $26.8 million in cash, cash equivalents and short-term investments compared
to $43.0 million as of December 31, 2009.
“Our
financial results reflect the continued investment in Novavax’s vaccine
candidates and prudent management of our financial and human resources,” said
Dr. Rahul Singhvi, President and CEO of Novavax. “In addition to
advancing our clinical programs, we are contending for a potentially significant
vaccine development contract with the U.S. government, we have hired outstanding
new executives to guide our clinical, pre-clinical and discovery programs, and
we have fortified our patent portfolio.”
Recent
Accomplishments
Novavax
recently reported the following corporate developments:
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·
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Receipt
of notification from HHS/BARDA that a potential influenza vaccine
development contract is in the “competitive
range”;
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·
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Achievement
of positive results from trial of trivalent seasonal influenza vaccine in
older adults;
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·
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Recruitment
of new Chief Medical and Chief Scientific Officers and appointment of new
Head of Process and Manufacturing Operations and Head of Analytical and
Quality Operations;
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Continued
R&D progress in discovery of new targets to broaden vaccine
pipeline;
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·
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Appointment
of Dr. James Young, an accomplished and distinguished member of the
biotech industry, to the Board of
Directors;
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·
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Completion
of construction of vaccine production facility in India by joint-venture
company, CPL Biologicals; and
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·
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Receipt
of key technology patent covering production of VLP vaccines from multiple
strains of seasonal and pandemic influenza
viruses.
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These
developments are described more fully in press releases available on the
company’s website, www.novavax.com.
Conference
Call
Novavax’s
management will host its quarterly conference call at 10:00 a.m. Eastern time
today. The live conference call will be accessible on Novavax’s
website at www.novavax.com under “Investor/Events” or by telephone at
1-877-212-6076 (domestic) or 1-707-287-9331 (international). A replay of
the webcast will be available on the Novavax website for 90 days after the
call and a replay of the conference call will be available beginning today at
1:00 pm through August 8, 2010 until 11:59 p.m. Eastern time. To
access the replay of the conference call, dial 1-800-642-1687 (domestic) or
1-706-645-9291 (international) and enter pass code 89793634.
About
Novavax
Novavax,
Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to
address a broad range of infectious diseases worldwide, including H1N1, using
advanced proprietary virus-like-particle (VLP) technology. The
company produces potent VLP-based recombinant vaccines utilizing new and
efficient manufacturing approaches. Novavax is committed to using its
VLP technology to create country-specific vaccine solutions. The
company has formed a joint venture with Cadila Pharmaceuticals, named CPL
Biologicals, to develop and manufacture vaccines, biological therapeutics and
diagnostics in India. Additional information about Novavax is
available on the company’s website: www.novavax.com.
Cautionary
Note Regarding Forward-Looking Statements
Statements
herein relating to future financial or business performance, conditions or
strategies and other financial and business matters, including expectations
regarding revenue, operating expenses, use of cash, and clinical developments
and anticipated milestones, including a BARDA contract and our assessment of the
results of our clinical trials and our patent coverage on VLP vaccines, are
forward-looking statements. Novavax cautions that these
forward-looking statements are subject to numerous assumptions, risks and
uncertainties, which change over time. We caution readers not to
place significant reliance on the forward-looking statements contained in this
release. Factors that may cause actual results to differ materially
from the results discussed in the forward-looking statements or historical
experience include, among other things, the following: our ability to progress
any product candidates into pre-clinical or clinical trials; the scope,
initiation, rate and progress of our pre-clinical studies and clinical trials
and other research and development activities; clinical trial results; even with
positive data from pre-clinical studies or clinical trials, the product
candidate may not prove to be safe and efficacious; regulatory approval is
needed before any vaccines can be sold in or outside the United States and, to
date, no governmental authority has approved any of our vaccine candidates for
sale; influenza is seasonal in nature, and if approval or commercial launch
after approval is not timely in relation to the influenza season, we may not be
able to manufacture or sell our influenza vaccines on terms favorable to us
until the next influenza season, if at all; we have not manufactured any of our
vaccine candidates at a commercial level; we utilize a unique
manufacturing process and the scale-up of that process may prove difficult
and/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 financing or otherwise; the inability to win any government
contracts/grants, including from BARDA, in a timely manner or if at all and
other factors referenced herein. Further information on the factors
and risks that could affect Novavax’s business, financial conditions and results
of operations, is contained in Novavax’s filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov, including the factors
discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for
the fiscal year ended December 31, 2009, as updated by our Quarterly Report on
Form 10-Q for the quarter ended March 31, 2010. These forward-looking
statements speak only as of the date of this earnings release and Novavax
assumes no duty to update such statements.
# #
#
NOVAVAX,
INC.
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS
(in
thousands, except per share information)
(unaudited)
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Three
Months Ended
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Six
Months Ended
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|||||||||||||||
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June
30,
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June
30,
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|||||||||||||||
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2010
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2009
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2010
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2009
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Revenue
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$ | 7 | $ | 29 | $ | 117 | $ | 50 | ||||||||
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Operating
expenses:
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Research
and development
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6,327 | 5,297 | 15,356 | 9,563 | ||||||||||||
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General
and administrative
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3,148 | 2,562 | 5,683 | 5,454 | ||||||||||||
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Total
operating expenses
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9,475 | 7,859 | 21,039 | 15,017 | ||||||||||||
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Loss
from continuing operations
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(9,468 | ) | (7,830 | ) | (20,922 | ) | (14,967 | ) | ||||||||
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Interest
income (expense), net
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42 | (251 | ) | 84 | (584 | ) | ||||||||||
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Impairment
of short-term investments
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— | (459 | ) | — | (1,338 | ) | ||||||||||
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Net
loss
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$ | (9,426 | ) | $ | (8,540 | ) | $ | (20,838 | ) | $ | (16,889 | ) | ||||
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Basic
and diluted net loss per share
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$ | (0.09 | ) | $ | (0.10 | ) | $ | (0.21 | ) | $ | (0.22 | ) | ||||
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Basic
and diluted weighted average
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||||||||||||||||
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number
of common shares outstanding
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100,694 | 84,832 | 100,442 | 76,807 | ||||||||||||
SELECTED
BALANCE SHEET DATA
(in
thousands)
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June
30,
2010
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December
31, 2009
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|||||||
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(unaudited)
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Cash
and cash equivalents
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$ | 9,446 | $ | 38,757 | ||||
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Short-term
investments
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17,340 | 4,193 | ||||||
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Total
current assets
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27,594 | 44,503 | ||||||
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Working
capital
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19,071 | 36,476 | ||||||
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Total
assets
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68,945 | 85,605 | ||||||
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Total
notes payable
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440 | 486 | ||||||
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Total
stockholders’ equity
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57,523 | 74,465 | ||||||
# #
#