Novavax Reports First Quarter 2015 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., May 7, 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 first quarter 2015.
Corporate Highlights
First Quarter and Subsequent Achievements:
RSV
* Completed enrollment of two ongoing clinical trials of its RSV F Vaccine,
including a Phase 2 study in elderly adults (60 years of age and older) and
a Phase 2 trial to protect infants via maternal immunization.
Ebola
* Initiated a randomized, observer-blinded, dose-ranging Phase 1 clinical
trial of our EBOV GP Vaccine in Australia to evaluate the safety and
immunogenicity of the vaccine, with and without Matrix-M(TM) adjuvant, in
230 healthy adults between 18 and 50 years of age.
Corporate Achievements
* Completed an underwritten public offering of approximately 27.8 million
shares, including shares pursuant to the underwriters' option, at $7.25 per
share resulting in total gross proceeds from this offering of approximately
$201 million before deducting the underwriters discount and offering
expenses; and
* Awarded 2015 Workplace Excellence Seal of Approval from the Alliance of
Workplace Excellence. Companies awarded the Workplace Excellence Seal of
Approval demonstrate outstanding commitments to innovative corporate culture
and management practices, employee growth and learning opportunities,
diversity and inclusion practices and commitment to corporate, social and
civic responsibilities.
2015 Anticipated Events
* During the third quarter of 2015, announce top-line clinical data from four
of our ongoing clinical trials, including:
* Phase 2 clinical trial of the RSV F Vaccine in elderly adults;
* Phase 2 clinical trial of the RSV F Vaccine in Phase 2 study to protect
infants via maternal immunization;
* Phase 2 clinical trial of the Quadrivalent Seasonal Influenza VLP; and
* Phase 1 clinical trial of the EBOV GP Vaccine in healthy adults.
"Novavax has now completed enrollment of the elderly and maternal immunization
RSV clinical trials. That achievement, combined with our ongoing Quadrivalent
Seasonal Influenza VLP vaccine and Ebola GP Vaccine clinical trials, will
position us for significant clinical data readouts in the second half of 2015,"
said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Our
March 2015 financing provided us with the resources to prepare for the next
steps, with our key objective to continue to execute our aggressive RSV F
Vaccine development plans."
Financial Results for the Three Months Ended March 31, 2015
Novavax reported a net loss of $24.4 million, or $0.10 per share, for the first
quarter of 2015, compared to a net loss of $13.8 million, or $0.07 per share,
for the first quarter of 2014.
Novavax revenue in the first quarter of 2015 increased 32% to $9.9 million,
compared to $7.5 million for the same period in 2014. The increase results
primarily from HHS BARDA's approval of the reimbursement of the Company's prior
Phase 2 Quadrivalent Seasonal Influenza VLP vaccine clinical trial (205 Trial)
costs, resulting in an additional $3.1 million in revenue in the quarter.
The cost of government contracts revenue in the first quarter of 2015 decreased
19% to $2.5 million, compared to $3.0 million for the same period in 2014. The
decrease in costs were associated with a lower level of activity in the first
quarter of 2015 associated with the Company's Phase 2 clinical trial of our
quadrivalent seasonal influenza vaccine candidate as compared to the Company's
Phase 1/2 clinical trial of our H7N9 pandemic influenza candidate with Matrix-M
in the same period in 2014; both programs are funded under our contract with HHS
BARDA.
Research and development expenses increased 78% to $25.9 million in the first
quarter of 2015, compared to $14.5 million for the same period in 2014. The
increase in research and development expenses was driven by activities relating
to the ongoing RSV F Vaccine clinical trials, the initiation of the Phase 1
clinical trial of our Ebola GP Vaccine candidate program and higher employee-
related expenses tied to the continued growth of the Company.
General and administrative expenses increased 36% to $5.8 million in the first
quarter of 2015, compared to $4.3 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 March 31, 2015, the Company had $327.7 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 first quarter of 2015
was $30.5 million, compared to $20.4 million for the same period in 2014. The
factors contributing to the change in operating cash usage were primarily due to
increased research and development costs relating to our vaccine candidates and
higher employee-related costs, as well as the timing of customer and vendor
payments.
Conference Call
Novavax management will host its quarterly conference call today at 4:30 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 "Investor Info"/"Events" tab on the Novavax website.
A replay of the conference call will be available starting at 7:30 p.m. on May
7, 2015 until midnight May 14, 2015. To access the replay by telephone, dial
(855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode
35660022. 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, 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
March 31,
-----------------------------
2015 2014
-----------------------------
(unaudited)
Revenue $ 9,877 $ 7,462
-----------------------------
Costs and expenses:
Cost of government contracts revenue 2,459 3,021
Research and development 25,888 14,518
General and administrative 5,843 4,308
-----------------------------
Total costs and expenses 34,190 21,847
-----------------------------
Loss from operations (24,313) (14,385)
Interest income (expense), net 85 (40)
Other expense (142) --
Realized gains on marketable securities -- 615
-----------------------------
Net loss $ (24,370) $ (13,810)
-----------------------------
Basic and diluted net loss per share $ (0.10) $ (0.07)
-----------------------------
Basic and diluted weighted average
number of common shares outstanding 241,223 208,927
-----------------------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
March 31, December 31, 2014
2015
------------- ------------------
(unaudited)
Cash and cash equivalents $ 215,050 $ 32,335
Marketable securities 112,685 135,721
Total current assets 350,094 188,158
Working capital 321,318 154,042
Total assets 438,841 276,002
Total notes payable and capital lease 990 1,173
obligations
Total stockholders' equity 399,706 229,618
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#1920029]
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Datum: 07.05.2015 - 22:50 Uhr
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