DGAP-News: Novavax, Inc. /
Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and
Initiation of Phase 1/2 Clinical Trial of Its H7N9 Avian Influenza VLP
Vaccine Candidate With Matrix-M(TM)
10.03.2014 / 21:19
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GAITHERSBURG, Md., 2014-03-10 21:18 CET (GLOBE NEWSWIRE) --
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused
on the discovery, development and commercialization of recombinant nanoparticle
vaccines and adjuvants, today reported its financial results for the fourth
quarter and year ended December 31, 2013 and announced the initiation of a
Phase 1/2 clinical trial of its H7N9 avian influenza VLP vaccine candidate with
its proprietary Matrix-M adjuvant. The trial is enrolling 610 healthy subjects
to evaluate the safety and immunogenicity of this vaccine and adjuvant.
Novavax Business Highlights
2013 Achievements:
-- Reported data from two RSV F-protein nanoparticle vaccine trials, one in
330 women of childbearing age and the other in 220 elderly subjects,
demonstrating strong immunogenicity of the RSV vaccine candidate;
-- Demonstrated in the RSV elderly subject trial that the vaccine could be
administered concurrently with a seasonal influenza vaccine to elicit
potentially protective levels of antibodies to both vaccine targets;
-- Initiated our H7N9 avian influenza VLP vaccine candidate program in April
and published the industry's first H7N9 vaccine human clinical trial data
showing highly protective levels of antibodies following vaccination in the
December 26th issue of the New England Journal of Medicine;
-- Acquired Novavax AB (previously Isconova AB) and its saponin-based adjuvant
Matrix-M to support Novavax' vaccine programs; and
-- Completed a successful $100 million secondary stock offering.
2014 Recent Events:
-- Extended the contract for Advanced Development of Recombinant Influenza
Products and Pandemic Preparedness with HHS BARDA; and
-- Initiated a U.S.-based Phase 1/2 clinical trial of H7N9 avian influenza VLP
vaccine candidate with Matrix-M, enrolling 610 healthy adult subjects
between 18 and 64 years old, under the Company's HHS BARDA contract.
2014 Anticipated Events:
-- Release of top-line data from the ongoing Phase 2 clinical trial of the RSV
F protein nanoparticle vaccine candidate in women of childbearing age in
the second quarter of 2014;
-- Release of top-line data from the recently initiated Phase 1/2 clinical
trial of the H7N9 avian influenza VLP vaccine candidate with Matrix-M in
the second half of 2014;
-- Initiate a Phase 2 clinical trial of our RSV F protein nanoparticle vaccine
in pregnant women in the fourth quarter of 2014; and
-- Initiate a Phase 2 clinical trial of our quadrivalent VLP seasonal
influenza vaccine in the fourth quarter of 2014.
'We made substantial progress in advancing our RSV and influenza vaccine
development programs during 2013 and I believe 2014 holds the potential for
even greater accomplishments across our entire pipeline,' said Stan Erck,
president and CEO of Novavax, Inc. 'Our rapid response to the emergence of an
avian H7N9 influenza strain continues to demonstrate the power and flexibility
of our vaccine and adjuvant technologies. This year we plan to report top-line
results from our ongoing RSV and influenza studies, initiate our first RSV
clinical trial in pregnant women and report top-line results from the first
study of our H7N9 avian influenza vaccine candidate with our Matrix-M adjuvant.
These will be important milestones for these programs for which I anticipate
continued success in 2014.'
Financial Results for the Fourth Quarter and Year Ended December 31, 2013
In connection with its acquisition on July 31, 2013, Novavax AB's operations
have been included in the company's consolidated results of operations and
financial position as of the acquisition date. Novavax reported a net loss of
$14.1 million, or $0.07 per share, for the fourth quarter of 2013, compared to
a net loss of $8.0 million, or $0.06 per share, for the fourth quarter of 2012.
For the full year 2013, the net loss was $52.0 million, or $0.31 per share,
compared to a net loss of $28.5 million, or $0.22 per share, for 2012.
Novavax revenue in the fourth quarter of 2013 increased 92% to $8.7 million as
compared to $4.6 million for the same period in 2012. The increase in revenue
was primarily due to the HHS BARDA amendment relating to H7N9 manufacturing and
other activities and the PATH amendment to support the company's Phase 2
clinical trial in women of childbearing age.
Research and development expenses increased 69% to $16.3 million in the fourth
quarter of 2013, compared to $9.6 million for the same period in 2012,
primarily as a result of increased costs relating to the company's RSV and
pandemic (H7N9) influenza clinical trials and higher employee-related costs.
General and administrative expenses increased 65% to $4.1 million in the fourth
quarter of 2013 as compared to $2.5 million for the same period in 2012,
resulting primarily from Novavax AB's expenses and higher professional fees.
As of December 31, 2013, the company had $133.1 million in cash and cash
equivalents and investments compared to $50.3 million as of December 31, 2012.
Net cash used in operating activities for 2013 was $45.4 million compared to
$18.2 million for 2012. The increase in cash usage from the prior year was
primarily due to higher research and development spending, including the
company's RSV and pandemic (H7N9) influenza clinical trials, as well as
increased employee-related costs.
Conference Call
Novavax management will host its quarterly conference call today at 4:30 p.m.
EDT. The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or
Canada) or 1 (707) 287-9331 (international). A webcast of the conference call
can also be accessed via a link on the home page of the Novavax website
(novavax.com) or through the 'Investor Info'/'Events' tab on the Novavax
website.
A replay of the conference call will be available starting at 7:30 p.m. on
March 10, 2014 until midnight May 1, 2014. To access the replay by telephone,
dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use
passcode 2459615. The replay will also be available as a webcast and can be
found on the 'Investor Info'/'Events' on the Novavax website.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant protein
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Novavax is involved in several international partnerships, including
collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea
and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company
located in Sweden. Together, Novavax' network supports its global
commercialization strategy to create real and lasting change in the
biopharmaceutical and vaccinology fields. Additional information about Novavax
is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant products are forward-looking statements. Novavax
cautions that these forward looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially from
those expressed or implied by such statements. These risks and uncertainties
include those identified under the heading 'Risk Factors' in the Novavax Annual
Report on Form 10-K for the year ended December 31, 2013, to be filed with the
Securities and Exchange Commission (SEC). Investors are cautioned not to place
considerable reliance on the forward-looking statements contained in this press
release. You are encouraged to read company filings with the SEC, available at
sec.gov, for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of the date of
this document, and the company undertakes no obligation to update or revise any
of the statements. The company's business is subject to substantial risks and
uncertainties, including those referenced above. Investors, potential
investors, and others should give careful consideration to these risks and
uncertainties.
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
Three Months Ended Twelve Months Ended
December 31, December 31,
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2013 2012 2013 2012
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(unaudited)
Revenue $ 8,748 $ 4,567 $ 20,915 $ 22,076
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Costs and expenses:
Cost of government contracts 2,602 1,953 8,222 14,692
revenue
Research and development 16,319 9,636 50,308 26,907
General and administrative 4,080 2,472 14,819 10,142
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Total costs and expenses 23,001 14,061 73,349 51,741
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Loss from operations (14,253) (9,494) (52,434) (29,665)
Interest income (expense), net 10 33 27 133
Other income 192 45 182 45
Realized gains on investments ? 879 ? 879
Change in fair value of warrant ? 502 267 101
liability
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Loss from operations before (14,051) (8,035) (51,958) (28,507)
income tax expense
Income tax expense 3 ? 25 ?
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Net loss $ (14,054) $ (8,035) $ (51,983) $ (28,507)
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Basic and diluted net loss per $ (0.07) $ (0.06) $ (0.31) $ (0.22)
share
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Basic and diluted weighted 208,538 145,069 169,658 131,726
average number of common shares
outstanding
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SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
December 31, December 31,
2013 2012
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Cash and cash equivalents $ 119,471 $ 17,399
Investments 13,597 32,945
Total current assets 145,001 50,408
Working capital 126,067 38,733
Total assets 235,937 102,345
Total notes payable and capital lease obligations 2,184 1,205
Total stockholders' equity 203,234 80,240
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
News Source: NASDAQ OMX
End of Corporate News
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Language: English
Company: Novavax, Inc.
United States
ISIN: US6700021040
End of News DGAP News-Service
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256784 10.03.2014
DGAP-News: Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and Initiation of Phase 1/2 Clinical Trial of Its H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM)
| Source: EQS Group AG