Novavax Reports Second Quarter 2016 Financial Results
August 09 2016 - 4:05PM
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™, 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™, 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™ 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) |
|
|
|
|
|
|
|
June
30, 2016 |
|
December 31,
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 obligations |
|
|
315,849 |
|
|
|
503 |
|
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@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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