Novavax Reports Third Quarter 2015 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Nov. 09, 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 third quarter and nine
months ended September 30, 2015.
Novavax Third Quarter and Subsequent Achievements
* Announced positive top-line data from a Phase 2 clinical trial of its RSV F-
protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older
adults (60 years of age and older). The vaccine was well-tolerated and
fulfilled the Company's expectations on the primary, secondary and
exploratory objectives of the trial. The trial is the first to demonstrate
efficacy of an active RSV immunization in any clinical trial population.
* Announced positive top-line data from a Phase 2 clinical trial of its RSV F
Vaccine to protect infants via maternal immunization. Significant anti-F,
PCA and microneutralizing antibody responses were elicited in mothers and
efficient antibody transfer from mothers to infants was observed.
* Announced that it has been awarded a grant of up to $89 million by the Bill
& Melinda Gates Foundation to support development of the RSV F Vaccine Phase
3 clinical trial in pregnant women. This grant will also support regulatory
licensing efforts, providing a path to WHO prequalification. Upon
licensure, Novavax has agreed to make the RSV F Vaccine affordable and
accessible to people in the developing world.
* Announced positive top-line data from a Phase 1 clinical trial of its RSV F
Vaccine in healthy children two to six years of age. All RSV F Vaccine
formulations and regimens were well-tolerated and highly immunogenic.
* Commenced enrollment in a Phase 2 rollover clinical trial of its RSV F
Vaccine in older adults. The trial is a randomized, observer-blinded,
placebo-controlled rollover trial designed to enroll the same 1600 older
adults who participated in the recently concluded prior Phase 2 trial.
* 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 the Department of Health and Human
Services, Biomedical Advanced Research and Development Authority (HHS BARDA)
(Contract No. HHSO 100201100012C), 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.
* Hosted its 3(rd) Annual Analyst and Investor Meeting.
Today's Announcement
* Initiation of a Phase 3 trial of the RSV F Vaccine in older adults
Near-term Anticipated Events
* Initiation of a Phase 3 trial of the RSV F Vaccine to protect infants via
maternal immunization, contingent upon discussions with regulatory
authorities
Summary
"The initiation of the first Phase 3 trial of our RSV F Vaccine in older adults
underscores our accomplishments to date and positions the company to bring the
first RSV vaccine to market. Our recent data announcements demonstrate the
safety and robust immunogenicity of the RSV F Vaccine across all three target
populations: older adults; infants via maternal immunization; and pediatrics,"
said Gregory Glenn, M.D., Senior Vice President, Research and Development. "Our
Phase 2 trial of the RSV F Vaccine in older adults was the first to demonstrate
efficacy of an active RSV immunization in any clinical trial population. In
addition, data from pregnant women in their third trimester provided an
important safety data and proof-of-concept for maternal immunization, with a
high level of transplacental antibody transfer."
"During the third quarter, we delivered positive results from five key clinical
programs including our RSV F Vaccine for older adults, infants via maternal
immunization and pediatrics, as well as our Seasonal Influenza Vaccine, and our
Ebola GP Vaccine. These results, coupled with today's initiation of our Phase 3
trial of our RSV F Vaccine in older adults, demonstrate Novavax' ability to
successfully advance our clinical stage programs along aggressive timelines,"
said Stanley C. Erck, President and CEO. "With successful phase 2 results, and
consistent execution, the Company is well-positioned to begin our second phase
3 trial in pregnant women in the first quarter of 2016."
Financial Results for the Three and Nine Months Ended September 30, 2015
Novavax reported a net loss of $33.1 million, or $0.12 per share, for the third
quarter of 2015, compared to a net loss of $19.7 million, or $0.08 per share,
for the third quarter of 2014. For the nine months ended September 30, 2015, the
net loss was $78.1 million, or $0.30 per share, compared to a net loss of $51.4
million, or $0.23 per share, for the same period in 2014.
Novavax revenue in the third quarter of 2015 decreased 21% to $6.5 million,
compared to $8.2 million for the same period in 2014. This decrease results from
a lower level of development activities under the HHS BARDA contract in the
third quarter of 2015 as compared to the same period in 2014.
The cost of government contracts revenue in the third quarter of 2015 decreased
32% to $2.7 million, compared to $4.0 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 third
quarter of 2015 as compared to the same period in 2014.
Research and development expenses increased 45% to $27.9 million in the third
quarter of 2015, compared to $19.2 million for the same period in 2014. The
increase in research and development expenses was driven by activities relating
to the RSV Vaccine and higher employee-related expenses, including non-cash
stock-based compensation, tied to the continued growth of the company.
General and administrative expenses increased 90% to $9.1 million in the third
quarter of 2015, compared to $4.8 million for the same period in 2014. The
increase in general and administrative expenses resulted from increased
employee-related expenses, including non-cash stock-based compensation, tied to
the continued growth of the company and professional fees for pre-
commercialization activities.
As of September 30, 2015, the company had $290.2 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 nine months of 2015 was
$71.3 million, compared to $47.2 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 8:00 a.m.
EST. 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 11:00 a.m. on
November 9, 2015 until midnight November 16, 2015. To access the replay by
telephone, dial 855-859-2056 (Domestic) or 404-537-3406 (International) and use
passcode 70778771. 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 and our Quarterly Reports on
Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015, 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 Nine Months Ended
September 30, September 30,
------------------------------- ----------------------------
2015 2014 2015 2014
--------------- --------------
(unaudited) (unaudited)
Revenue $ 6,525 $ 8,214 $ 30,397 $ 23,935
--------------- --------------- -------------- -------------
Costs and
expenses:
Cost of
government
contracts
revenue 2,747 4,027 8,054 12,150
Research and
development 27,917 19,219 78,686 48,940
General and
administrative 9,060 4,757 21,991 14,871
--------------- --------------- -------------- -------------
Total costs
and expenses 39,724 28,003 108,731 75,961
--------------- --------------- -------------- -------------
Loss from
operations (33,199 ) (19,789 ) (78,334 ) (52,026 )
Interest income
(expense), net 130 81 324 10
Other income
(expense) (51 ) (19 ) (121 ) -
Realized gains on
marketable
securities - - - 615
Net loss
$ (33,120 ) $ (19,727 ) $ (78,131 ) $ (51,401 )
--------------- --------------- -------------- -------------
Basic and diluted
net loss per share $ (0.12 ) $ (0.08 ) $ (0.30 ) $ (0.23 )
--------------- --------------- -------------- -------------
Basic and diluted
weighted average
number of common
shares
outstanding 269,554 238,304 259,703 221,578
--------------- --------------- -------------- -------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
September
30, December 31,
2015 2014
--------------- --------------
(unaudited)
Cash and cash equivalents $ 138,144 $ 32,335
Marketable securities 152,042 135,721
Total current assets 310,102 188,158
Working capital 285,229 154,042
Total assets 404,634 276,002
Total notes payable and capital lease obligation 664 1,173
Total stockholders' equity 367,016 229,618
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#1965453]
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Datum: 10.11.2015 - 04:05 Uhr
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News-ID 433191
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