Novavax Reports Fourth Quarter and Year-End 2014 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Feb. 26, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced its financial results for the fourth quarter and
twelve months ended December 31, 2014.
Corporate Highlights
Fourth Quarter and Subsequent Achievements:
RSV
* Initiated a Phase 2 clinical trial of its RSV F-Protein nanoparticle vaccine
candidate (RSV F Vaccine) in 1,600 elderly adults (greater than or equal to
60 years of age);
* Received the U.S. Food and Drug Administration's (FDA) Fast Track
Designation of our RSV F Vaccine for protection of infants via maternal
immunization, which, among other advantages, provides the potential for
priority review (shorter Biologics License Application review) that could
result in improved timeline to licensure;
* Initiated enrollment in a Phase 1 clinical trial of our RSV F Vaccine in
healthy children, the first study of this vaccine candidate to be conducted
in a pediatric population; and
* Presented new positive data from the first clinical study of our RSV F
Vaccine in women of childbearing age at the 8th Vaccine & ISV Congress,
showing 50% reduction in infection in the vaccinated women relative to
placebo. This data suggests that the vaccine may be efficacious in future
clinical testing.
Influenza
* Initiated a randomized, observer-blinded, dose-ranging Phase 2 clinical
trial of our recombinant quadrivalent seasonal influenza virus-like particle
(VLP) vaccine candidate (Seasonal Influenza VLP) in 400 healthy adults. This
trial is being conducted under our contract with the U.S. Department of
Health and Human Services, Biomedical Advanced Research and Development
Authority (BARDA) (Contract No. HHSO 100201100012C) for the development of
Novavax' recombinant vaccines to address seasonal influenza and influenza
strains with pandemic potential; and
* Received the FDA's Fast Track Designation of our Pandemic H7N9 Influenza VLP
vaccine candidate (Pandemic H7N9 VLP) with Matrix-M(TM) adjuvant, which
recognizes the public health risks of the H7N9 strain and may allow for an
improved timeline to licensure via the potential for accelerated approval
and priority review.
Ebola
* Initiated a novel Ebola Glycoprotein (GP) recombinant nanoparticle vaccine
candidate (EBOV GP Vaccine) program based on the currently circulating
Makona strain (previously referred to as the Guinea strain) of Ebola virus;
* Presented positive pre-clinical results at the 8th Vaccine & ISV Congress of
our EBOV GP Vaccine with Matrix-M adjuvant, showing seroprotective
antibodies and cross-neutralization to a previously circulating Ebola virus
strain;
* Announced significant immunogenicity and efficacy data demonstrating the
EBOV GP Vaccine is the first subunit Ebola GP-based vaccine to provide
protection in non-human primates. Non-human primates received two injections
of a 5µg dose of the EBOV GP Vaccine with Matrix-M adjuvant. As expected,
the challenge was lethal for the control animal whereas, in sharp contrast,
100% of the immunized animals were protected; and
* Initiated a randomized, observer-blinded, dose-ranging Phase 1 clinical
trial of our EBOV GP Vaccine in Australia to evaluate the safety and
immunogenicity of the vaccine, with and without Matrix-M adjuvant, in 230
healthy adults between 18 and 50 years of age.
2015 Anticipated Events:
* Announce top-line data from the Phase 1 clinical trial our EBOV GP Vaccine
in mid-2015;
* Announce top-line data from the Phase 2 clinical trial of our Seasonal
Influenza VLP in the second quarter of 2015;
* Announce top-line data from the Phase 2 clinical trial of our RSV F Vaccine
in healthy women in their third trimester of pregnancy in the third quarter
of 2015;
* Announce top-line data from the Phase 2 clinical trial of our RSV F Vaccine
in elderly adults in the third quarter of 2015; and
* Announce top-line data from the Phase 1 clinical trial of our RSV F Vaccine
in healthy pediatrics in late 2015 or in the first half of 2016.
"We have initiated five clinical trials within the last six months, including
advancing both our RSV and seasonal influenza programs into Phase 2 clinical
trials, while introducing our new Ebola vaccine into the clinic," said Stanley
C. Erck, President and Chief Executive Officer of Novavax. "These achievements
underscore the strength of our vaccine technology, capability of our
manufacturing platform and experience of our leadership team. We look forward to
carrying this momentum through 2015, with important clinical data readouts
expected in our RSV, seasonal influenza and Ebola programs."
Financial Results for the Three and Twelve Months Ended December 31, 2014
Novavax reported a net loss of $31.5 million, or $0.13 per share, for the fourth
quarter of 2014, compared to a net loss of $14.1 million, or $0.07 per share,
for the fourth quarter of 2013. For the twelve months ended December 31, 2014,
the net loss was $82.9 million, or $0.37 per share, compared to a net loss of
$52.0 million, or $0.31 per share for 2013.
Novavax revenue in the fourth quarter of 2014 decreased 23% to $6.7 million,
compared to $8.7 million for the same period in 2013. Revenue for the full year
2014 increased 47% to $30.7 million, compared to $20.9 million in 2013. The
increase in the full year revenue results from the Phase 1/2 clinical trial of
our H7N9 pandemic influenza vaccine candidate with Matrix-M and activities
relating to the preparation and initiation of the Phase 2 clinical trial of our
Seasonal Influenza VLP; both programs are funded under our contract with HHS
BARDA.
The cost of government contracts revenue in the fourth quarter of 2014 increased
9% to $2.8 million, compared to $2.6 million for the same period in 2013. For
the full year 2014, cost of government contracts revenue increased 82% to $15.0
million, compared to $8.2 million in 2013. The increase in costs for the full
year 2014 were associated with the Phase 1/2 clinical trial of our H7N9 pandemic
influenza candidate with Matrix-M adjuvant and activities relating to the
preparation and initiation of the Phase 2 clinical trial of our Seasonal
Influenza VLP; both programs are funded under our contract with HHS BARDA.
Research and development expenses increased 87% to $30.5 million in the fourth
quarter of 2014, compared to $16.3 million for the same period in 2013. For the
full year 2014, research and development expenses increased 58% to $79.4
million, compared to $50.3 million in 2013. The increase in research and
development expenses for the full year 2014 is driven by activities relating to
the preparation and initiation of three RSV F Vaccine candidate clinical trials
in 2014, the initiation of our Ebola vaccine candidate program and higher
employee-related expenses tied to the continued growth of the company.
General and administrative expenses increased 24% to $5.1 million in the fourth
quarter of 2014, compared to $4.1 million for the same period in 2013. For the
full year 2014, general and administrative expenses increased 34% to $19.9
million, compared to $14.8 million in 2013. The increase in general and
administrative expenses for the full year 2014 resulted from increased employee-
related expenses tied to the continued growth of the company.
As of December 31, 2014, the company had $168.1 million in cash and cash
equivalents and marketable securities compared to $133.1 million as of December
31, 2013. Net cash used in operating activities for 2014 was $67.0 million,
compared to $45.4 million for 2013. The factors contributing to the change in
cash usage were primarily due to increased costs relating to our RSV F Vaccine
candidate and higher employee-related costs, as well as the timing of vendor
payments.
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 877-212-6076 (U.S. or Canada)
or 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
February 26, 2015 until midnight March 5, 2015. To access the replay by
telephone, dial 855-859-2056 (Domestic) or 404-537-3406 (International) and use
passcode 89629680. 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 vaccine company committed to
delivering novel products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the
foundation for groundbreaking innovation that improves global health through
safe and effective vaccines. 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, 2014, to be filed with the
Securities and Exchange Commission (SEC). We caution investors not to place
considerable reliance on the forward-looking statements contained in this press
release. You are encouraged to read our 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 we undertake no obligation to update or revise any of the
statements. Our 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 STATEMENTS OF OPERATIONS
(in thousands, except per share information)
Three Months Ended Twelve Months Ended
December 31, December 31,
------------------------------------------------
2014 2013 2014 2013
------------------------------------------------
(unaudited)
Revenue $ 6,724 $ 8,748 $ 30,659 $ 20,915
------------------------------------------------
Costs and expenses:
Cost of government contracts
revenue 2,837 2,602 14,987 8,222
Research and development 30,495 16,319 79,435 50,308
General and administrative 5,056 4,080 19,928 14,819
------------------------------------------------
Total costs and expenses 38,388 23,001 114,350 73,349
------------------------------------------------
Loss from operations (31,664) (14,253) (83,691) (52,434)
Interest income (expense), net 118 10 129 27
Other income, net -- 192 -- 182
Realized gains on marketable
securities -- -- 615 --
Change in fair value of
warrant liability -- -- -- 267
------------------------------------------------
Loss from operations before
income tax expense (31,546) (14,051) (82,947) (51,958)
Income tax expense -- 3 -- 25
------------------------------------------------
Net loss $ (31,546) $ (14,054) $ (82,947) $ (51,983)
------------------------------------------------
Basic and diluted net loss per
share $ (0.13) $ (0.07) $ (0.37) $ (0.31)
------------------------------------------------
Basic and diluted weighted
average number of common
shares outstanding 238,519 208,538 225,848 169,658
------------------------------------------------
SELECTED BALANCE SHEET DATA
(in thousands)
December 31, December 31,
2014 2013
--------------------------
Cash and cash equivalents $ 32,335 $ 119,471
Marketable securities 135,721 13,597
Total current assets 188,158 145,001
Working capital 154,042 126,879
Total assets 276,002 235,125
Total notes payable and capital lease obligations 1,173 2,184
Total stockholders' equity 229,618 203,234
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
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Source: Novavax, Inc. via GlobeNewswire
[HUG#1897887]
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Datum: 26.02.2015 - 22:37 Uhr
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News-ID 374766
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