Novavax Reports First Quarter 2016 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., May 04, 2016 (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 first quarter ended March 31, 2016.
Novavax First Quarter Achievements:
* Continued execution of Resolve(TM), a pivotal Phase 3 trial of our RSV F
Vaccine in older adults (60 years of age and older). Resolve 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. Prepare 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. Prepare is supported
by a grant of up to $89 million from the Bill & Melinda Gates Foundation
(BMGF).
* Issued a total of $325 million Convertible Senior Notes, resulting in net
proceeds of $276.5 million. The Notes' initial conversion price of
approximately $6.81 per common share represents a 22.5% premium to Novavax'
common stock on January 25, 2016, the day the Notes were issued. In
conjunction with the issuance of the Notes, the Company entered into capped
call transactions with an initial cap price of $9.73 per share. The capped
call will serve to reduce dilution from issuance of shares upon conversion
at prices greater than the Notes' conversion price of $6.81.
* Appointed Bob Darius to Senior Vice President, Quality Operations and
promoted Gregory M. Glenn, M.D., to President, Research & Development, Amy
B. Fix to Senior Vice President, Regulatory Affairs, Louis F. Fries III,
M.D., to Senior Vice President and Chief Medical Officer, and Iksung Cho to
Vice President, Biostatistics.
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 in the second half of 2016.
Summary
"During the first quarter, we continued to successfully execute on our two
ongoing pivotal Phase 3 trials of our RSV F Vaccine. We also raised $325 million
in a successful Convertible Senior Notes offering, which strengthens Novavax'
balance sheet ahead of data from the pivotal Phase 3 Resolve clinical trial,"
said Stanley C. Erck, President and CEO. "We are pleased 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. We remain well positioned to announce value
creating data from the Resolve trial and the Phase 2 rollover trial in older
adults in 2016."
Financial Results for the Three Months Ended March 31, 2016
Novavax reported a net loss of $77.3 million, or $0.29 per share, for the first
quarter of 2016, compared to a net loss of $24.4 million, or $0.10 per share,
for the first quarter of 2015.
Novavax revenue in the first quarter of 2016 decreased 57% to $4.2 million,
compared to $9.9 million for the same period in 2015. Lower revenue under the
HHS BARDA contract of $7.3 million is the primary driver of this decrease. The
lower HHS BARDA revenue is the result of a lower level of activity in the three
months ended March 31, 2016, as compared to the same period in 2015, along with
a one-time revenue recognition of $3.1 million in the first quarter of 2015.
This decrease in HHS BARDA revenue was partially offset by $1.6 million in
revenue recorded under the BMGF grant relating to our ongoing Prepare clinical
trial.
Research and development expenses increased 143% to $69.0 million in the first
quarter of 2016, compared to $28.3 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 80% to $10.5 million in the first
quarter of 2016, compared to $5.8 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 first quarter of 2016 includes $2.1
million of interest expense relating the Company's Convertible Senior Notes
offering.
As of March 31, 2016, the company had $433.9 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 quarter of 2016
was $69.8 million, compared to $30.5 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. As
previously mentioned, Novavax completed a $325 million Convertible Senior Notes
offering in the first quarter of 2016.
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 95870834. 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 May
4, 2016 until midnight May 11, 2016. To access the replay by telephone, dial
(855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode
95870834. 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
Three Months Ended
March 31,
-----------------------------
2016 2015
-----------------------------
(unaudited)
Revenue $ 4,218 $ 9,877
-----------------------------
Expenses:
Research and development 68,952 28,347
General and administrative 10,528 5,843
-----------------------------
Total expenses 79,480 34,190
-----------------------------
Loss from operations (75,262 ) (24,313 )
Interest income (expense), net (1,957 ) 85
Other expense (33 ) (142 )
-----------------------------
Net loss $ (77,252 ) $ (24,370 )
-----------------------------
Basic and diluted net loss per share $ (0.29 ) $ (0.10 )
-----------------------------
Basic and diluted weighted average
number of common shares outstanding 270,179 241,223
-----------------------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
March 31, December
31,
2016 2015
------------------------
(unaudited)
Cash and cash equivalents $ 132,225 $ 93,108
Marketable securities 301,642 137,548
Total current assets 484,595 287,257
Working capital 413,544 210,763
Total assets 592,507 386,038
Total notes payable and capital lease obligation 315,614 503
Total stockholders' equity 185,433 292,669
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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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire
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