Novavax Reports Second Quarter 2016 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Aug. 09, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) today announced its financial results for the second quarter and
six months ended June 30, 2016.
Novavax Second Quarter Achievements:
* Announced a new seasonal combination respiratory vaccine program. Novavax
demonstrated the ability to combine the RSV F and influenza nanoparticle
vaccines, bringing together a vaccine approach that induces broadly
neutralizing antibodies against both influenza and RSV. Novavax' program was
unveiled at the New Approaches to Vaccines for Human and Veterinary Tropical
Diseases Keystone Symposia in Cape Town, South Africa in June 2016.
* Continued execution of Resolve(TM), a pivotal Phase 3 trial of our RSV F
Vaccine in older adults (60 years of age and older). The Resolve trial is a
randomized, observer-blinded, placebo-controlled trial in 11,850 older
adults at 60 sites in the United States. The primary efficacy objective is
the prevention of moderate-severe RSV-associated lower respiratory tract
disease, as defined by the presence of multiple lower respiratory tract
symptoms. Enrollment was completed in the fourth quarter of 2015.
* Ongoing execution of a Phase 2 rollover clinical trial of our RSV F Vaccine
in 1,330 older adults. The trial is a randomized, observer-blinded, placebo-
controlled rollover trial designed to enroll from the population of older
adults who participated in the prior Phase 2 trial. The primary endpoints of
the trial will evaluate safety and serum anti-F IgG antibody concentrations
in response to immunization with our RSV F Vaccine. Enrollment was completed
in the fourth quarter of 2015.
* Expanded enrollment of Prepare(TM), a pivotal Phase 3 trial of our RSV F
Vaccine in healthy pregnant women, to multiple international sites to take
advantage of the RSV season in the southern hemisphere. The Prepare trial is
a randomized, observer-blinded, placebo-controlled trial. The primary
objective is to determine the efficacy of maternal immunization with our RSV
F Vaccine against symptomatic RSV lower respiratory tract infection with
hypoxemia in infants through the first 90 days of life. The Prepare trial is
supported by a grant of up to $89 million from the Bill & Melinda Gates
Foundation (BMGF).
2016 Anticipated Events:
* Announce top-line data from Resolve, the Phase 3 pivotal RSV F Vaccine trial
in older adults in the third quarter of 2016; and
* Announce top-line data from the Phase 2 RSV F Vaccine rollover trial in
older adults between now and year end.
Summary
"This is an incredibly exciting time for Novavax, as we near the announcement of
Phase 3 data for our RSV F Vaccine in older adults. Our regulatory expertise,
manufacturing operations, and strong balance sheet, in conjunction with the pre-
commercialization activities we have initiated, leave us very well-positioned to
execute on this opportunity," said Stanley C. Erck, President and CEO. "We also
continue to see significant interest from a number of multinational, world-class
vaccine companies seeking potential partnership and commercialization rights to
our RSV F Vaccine franchise outside of North America."
Financial Results for the Three and Six Months Ended June 30, 2016
Novavax reported a net loss of $79.4 million, or $0.29 per share, for the second
quarter of 2016, compared to a net loss of $20.6 million, or $0.08 per share,
for the second quarter of 2015. For the six months ended June 30, 2016, the net
loss was $156.6 million, or $0.58 per share, compared to a net loss of $45.0
million, or $0.18 per share, for the same period in 2015.
Novavax revenue in the second quarter of 2016 decreased 82% to $2.5 million,
compared to $14.0 million for the same period in 2015. Lower revenue under the
BARDA contract of $13.6 million is the primary driver of this decrease. The
decline in BARDA revenue in the second quarter of 2016 is the result of the one-
time recognition of $7.7 million in revenue in the second quarter of 2015, and
the recent advances in the Company's seasonal influenza nanoparticle program
which resulted in the wind-down of VLP influenza activities under the BARDA
contract. This decrease in BARDA revenue was partially offset by $1.7 million in
revenue recorded under the BMGF grant relating to our ongoing Prepare clinical
trial.
Research and development expenses increased 134% to $64.9 million in the second
quarter of 2016, compared to $27.7 million for the same period in 2015. The
increase in research and development expenses was primarily due to increased
costs associated with the clinical trials and development activities of our RSV
F Vaccine and higher employee-related costs, including non-cash stock-based
compensation.
General and administrative expenses increased 99% to $14.1 million in the second
quarter of 2016, compared to $7.1 million for the same period in 2015. The
increase was primarily due to higher employee-related costs, including non-cash
stock-based compensation expense, and professional fees for pre-
commercialization activities, as compared to the same period in 2015.
Interest income (expense), net for the second quarter of 2016 includes $3.0
million of interest expense relating to the Company's Convertible Senior Notes.
As of June 30, 2016, the Company had $366.4 million in cash and cash equivalents
and marketable securities compared to $230.7 million as of December 31, 2015.
Net cash used in operating activities for the first six months of 2016 was
$131.9 million, compared to $42.8 million for same period in 2015. The increase
in cash usage was primarily due to increased costs relating to our RSV F
Vaccine, higher employee-related costs and timing of vendor payments.
Conference Call
Novavax management will host its quarterly conference call today at 4:30 p.m.
ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or
(707) 287-9331 (International), passcode 59901631. 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 7:00 p.m. on
August 9, 2016 until midnight August 16, 2016. To access the replay by
telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and
use passcode 59901631. 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, 2015 as 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)
For the Three Months For the Six Months
Ended June 30, Ended June 30,
----------------------------- -----------------------------
2016 2015 2016 2015
--------------- ------------- ---------------- ------------
(unaudited) (unaudited)
Revenue $ 2,505 $ 13,996 $ 6,723 $ 23,872
--------------- ------------- ---------------- ------------
Expenses:
Research and
development 64,904 27,729 133,856 56,076
General and
administrative 14,099 7,088 24,627 12,931
--------------- ------------- ---------------- ------------
Total expenses 79,003 34,817 158,483 69,007
--------------- ------------- ---------------- ------------
Loss from
operations (76,498 ) (20,821 ) (151,760 ) (45,135 )
Interest income
(expense), net (2,842 ) 108 (4,799 ) 194
Other income
(expense) (11 ) 72 (44 ) (70 )
--------------- ------------- ---------------- ------------
Net loss $ (79,351 ) $ (20,641 ) $ (156,603 ) $ (45,011 )
--------------- ------------- ---------------- ------------
Basic and diluted
net loss per
share $ (0.29 ) $ (0.08 ) $ (0.58 ) $ (0.18 )
--------------- ------------- ---------------- ------------
Basic and diluted
weighted average
number of common
shares
outstanding 270,760 268,083 270,469 254,727
--------------- ------------- ---------------- ------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
December
June 30, 31,
2016 2015
--------------- ------------
(unaudited)
Cash and cash equivalents $ 89,395 $ 93,108
Marketable securities 276,967 137,548
Total current assets 419,981 287,257
Working capital 338,103 210,763
Total assets 525,004 386,038
Total notes payable and capital lease 315,849 503
obligations
Total stockholders' equity 110,117 292,669
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Associate Director, 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#2034181]
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Datum: 09.08.2016 - 22:05 Uhr
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News-ID 488184
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