Novavax Reports Second Quarter 2015 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Aug. 10, 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 second quarter and six
months ended June 30, 2015.
Novavax Second Quarter and Subsequent Achievements:
* Announced positive top-line data from a Phase 2 trial of its RSV F-protein
nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The trial
demonstrated statistically significant vaccine efficacy in the prevention of
symptomatic RSV disease in older adults, the first vaccine to demonstrate
efficacy against RSV disease in any population. The trial detected an
attack rate of 4.9% for symptomatic RSV disease in 1,600 older adults.
Similar to the Company's findings in prior trials, there were greater than
four-fold increases in both anti-F IgG and palivizumab-competing antibody
(PCA) concentrations with serological responses in over 90% of vaccinated
participants.
Additional details on this data are available via a multimedia news release:
http://www.multivu.com/players/English/7590851-novavax-rsv/
* Announced positive top-line data from a Phase 2 trial of its recombinant
quadrivalent seasonal influenza virus-like particle candidate (Quadrivalent
Seasonal Influenza VLP). The trial, funded in whole or part with Federal
funds from the Company's contract with HHS BARDA, demonstrated that the
Quadrivalent Seasonal Influenza VLP vaccine candidate was well-tolerated
with no vaccine-related serious adverse events. The trial met its
immunogenicity targets and demonstrated potential to meet the Center for
Biological Evaluation and Research (CBER) criteria for accelerated approval.
* Delivered positive top-line data from a Phase 1 clinical trial of its Ebola
virus glycoprotein (GP) recombinant nanoparticle vaccine (Ebola GP Vaccine)
candidate adjuvanted with Matrix-M(TM). The trial demonstrated that the
adjuvanted Ebola GP Vaccine was highly immunogenic, well-tolerated and
resulted in significant antigen dose-sparing.
* Appointed Gail K. Boudreaux to the Board of Directors. Ms. Boudreaux brings
over 30 years of experience from a broad spectrum of health care
operations. She most recently served as the Executive Vice President
of UnitedHealth Group and was the Chief Executive Officer of
UnitedHealthcare. She has been honored as one of Fortune's 50 Most Powerful
Women in American Business for the last six years and was recognized
by Modern Healthcare as one of the Top 25 Women in Healthcare.
2015 Anticipated Events:
* Announcement of safety and immunogenicity data from the RSV F Vaccine Phase
2 trial to protect infants via maternal immunization; and
* Initiation of a Phase 3 trial of the RSV F Vaccine in older adults as early
as the fourth quarter.
Summary:
"We have been committed to delivering preliminary results from four of our
clinical programs during the second and third quarters of this year. In the last
month, we have delivered positive top-line data from three clinical trials; our
RSV F Vaccine for older adults, Seasonal Influenza Vaccine, and Ebola GP
Vaccine. In addition, our RSV F Vaccine Phase 2 trial to protect infants via
maternal immunization is scheduled to report later this quarter. In doing so, we
demonstrate the breadth and power of our recombinant vaccine technology," said
Stanley C. Erck, President and Chief Executive Officer of Novavax. "The results
from these clinical trials provide us with the foundation to determine the next
steps in the development plans of these programs. Given the positive top-line
Phase 2 data reported today, we look forward to discussions with the regulatory
authorities and the opportunity to pursue our goal to initiate a Phase 3
clinical trial of our RSV F Vaccine in older adults later this year."
Financial Results for the Three and Six Months Ended June 30, 2015
Novavax reported a net loss of $20.6 million, or $0.08 per share, for the second
quarter of 2015, compared to a net loss of $17.9 million, or $0.08 per share,
for the second quarter of 2014. For the six months ended June 30, 2015, the net
loss was $45.0 million, or $0.18 per share, compared to a net loss of $31.7
million, or $0.15 per share, for the same period in 2014.
Novavax revenue in the second quarter of 2015 increased 69% to $14.0 million,
compared to $8.3 million for the same period in 2014. This increase results from
the recovery of additional costs under the HHS BARDA contract for the settlement
of indirect rates for fiscal years 2011 and 2012, resulting in an additional
$7.7 million in revenue for the quarter. This increase in revenue was partially
offset by a decrease in revenue resulting from a lower level of development
activities under the HHS BARDA contract and our PATH agreement in the second
quarter of 2015 as compared to the same period in 2014.
The cost of government contracts revenue in the second quarter of 2015 decreased
47% to $2.7 million, compared to $5.1 million for the same period in 2014. The
decrease in cost of government contracts revenue was associated with a lower
level of development activities under the HHS BARDA contract in the second
quarter of 2015 as compared to the same period in 2014.
Research and development expenses increased 65% to $25.0 million in the second
quarter of 2015, compared to $15.2 million for the same period in 2014. The
increase in research and development expenses was driven by activities relating
to the RSV Vaccine, the Ebola GP Vaccine and higher employee-related expenses
tied to the continued growth of the company.
General and administrative expenses increased 22% to $7.1 million in the second
quarter of 2015, compared to $5.8 million for the same period in 2014. The
increase in general and administrative expenses resulted from increased
employee-related expenses tied to the continued growth of the company.
As of June 30, 2015, the company had $314.9 million in cash and cash equivalents
and marketable securities compared to $168.1 million as of December 31, 2014.
Net cash used in operating activities for the six months of 2015 was $42.8
million, compared to $31.4 million for the same period in 2014. The factors
contributing to the change in operating cash usage were primarily due to
increased costs relating to our RSV F Vaccine, Ebola GP Vaccine and higher
employee-related expenses, as well as the timing of customer and vendor
payments.
Conference Call
Novavax management will host its quarterly conference call today at 4:45 p.m.
EDT. The dial-in number for the conference call is (877) 212-6076 (Domestic) 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 "Investors"/ "Events" tab on the Novavax website.
A replay of the conference call will be available starting at 7:30 p.m. on
August 10, 2015 until midnight August 17, 2015. To access the replay by
telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and
use passcode 97557844. The replay will also be available as a webcast and can be
found on the "Investors"/ "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, 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 CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
Three Months Ended Six Months Ended
June 30, June 30,
2015 2014 2015 2014
(unaudited) (unaudited)
Revenue $ 13,996 $ 8,259 $ 23,872 $ 15,721
Costs and expenses:
Cost of government 2,687 5,102 5,307 8,123
contracts revenue
Research and 25,042 15,202 50,769 29,720
development
General and 7,088 5,806 12,931 10,114
administrative
Total costs and 34,817 26,110 69,007 47,957
expenses
Loss from operations (20,821 ) (17,851 ) (45,135 ) (32,236 )
Interest income 108 (31 ) 194 (71 )
(expense), net
Other income 72 18 (70 ) 18
(expense)
Realized gains on
marketable - - - 615
securities
Net loss $ (20,641 ) $ (17,864 ) $ (45,011 ) $ (31,674 )
Basic and diluted $ (0.08 ) $ (0.08 ) $ (0.18 ) $ (0.15 )
net loss per share
Basic and diluted
weighted average 268,083 217,178 254,727 213,075
number of common
shares outstanding
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
June 30, December
31,
2015 2014
(unaudited)
Cash and cash equivalents $ 167,384 $ 32,335
Marketable securities 147,554 135,721
Total current assets 332,979 188,158
Working capital 305,926 154,042
Total assets 424,698 276,002
Total notes payable and capital lease obligations 823 1,173
Total stockholders' equity 387,603 229,618
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir(at)novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull(at)russopartnersllc.com
todd.davenport(at)russopartnersllc.com
212-845-4271
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Source: Novavax, Inc. via GlobeNewswire
[HUG#1944765]
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Datum: 10.08.2015 - 22:16 Uhr
Sprache: Deutsch
News-ID 412739
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