DGAP-News: Novavax, Inc. /
Novavax Reports First-Quarter 2014 Financial Results
07.05.2014 / 22:13
---------------------------------------------------------------------
GAITHERSBURG, Md., 2014-05-07 22:13 CEST (GLOBE NEWSWIRE) --
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused
on the discovery, development and commercialization of recombinant nanoparticle
vaccines and adjuvants, today reported its financial results for the first
quarter ended March 31, 2014.
Novavax Corporate Highlights
Year-to-date 2014 Achievements:
-- Delivered positive top-line data from a dose-confirmatory Phase 2 clinical
trial of its RSV F-protein vaccine candidate in 720 women of childbearing
age, showing:
-- Vaccine candidate was well-tolerated with no vaccine-related serious
adverse events
-- Highest immune responses observed with a single dose of vaccine combined
with aluminum phosphate adjuvant
-- Palivizumab-like antibodies exceeded levels observed in previous trials,
and
-- High levels of antibodies developed within 14 days after immunization
and persisted over 91-day observation period;
-- Initiated a U.S. Phase 1/2 clinical trial of H7N9 avian influenza VLP
vaccine candidate with Matrix-M(tm), targeted to enroll 610 healthy adult
subjects between 18 and 64 years old, under the company's HHS BARDA
contract;
-- Published data in Vaccine demonstrating that an investigational vaccine
candidate developed by Novavax against recently emerged Middle East
Respiratory Syndrome Coronavirus (MERS-CoV) blocked infection in laboratory
studies, adding further evidence of the power and potential of Novavax'
recombinant nanoparticle vaccine technology;
-- Demonstrated commitment to alliance management through extension of HHS
BARDA contract for development of seasonal and pandemic influenza vaccines
and continuation of RSV vaccine partnership on maternal immunization with
PATH - both collaborations bring valuable development resources, insight
and experience, along with non-dilutive sources of capital funding; and
-- Expanded Management team with appointment of John Trizzino, Senior Vice
President, Commercial Operations, Cindy Oliver as Senior Vice President,
Process Development, and Sven Andreasson as Senior Vice President,
Corporate Development.
2014 Anticipated Events:
-- Release of top-line data from recently initiated Phase 1/2 clinical trial
of H7N9 avian influenza VLP vaccine candidate with Matrix-M in the second
half of 2014;
-- Initiate Phase 2 clinical trial of its RSV F-protein vaccine candidate for
protection of infants via maternal immunization in pregnant women in fourth
quarter of 2014;
-- Initiate Phase 2 clinical trial of its quadrivalent VLP seasonal influenza
vaccine in the fourth quarter of 2014; and
-- Initiate Phase 1 combination RSV/seasonal influenza clinical trial and
Phase 1 pediatric RSV clinical trial, both in late 2014 or early 2015.
'Following the substantial progress in our RSV and influenza vaccine
development programs in 2013, I am delighted with our accomplishments in the
first quarter of 2014. Based on this first quarter activity, I continue to
believe that 2014 represents greater potential accomplishments across our
entire pipeline than we have ever had in our company's history,' said Stan
Erck, president and CEO of Novavax. 'Our recently announced top-line data from
the Phase 2 clinical trial in women of child bearing age gives us flexibility
in the development of our RSV F vaccine candidate, not just for a maternal
immunization strategy, but across all potential populations impacted by RSV.'
Financial Results for the First Quarter March 31, 2014
In connection with its acquisition on July 31, 2013, Novavax AB's operations
have been included in the company's consolidated results of operations and
financial position as of the acquisition date. Novavax reported a net loss of
$13.8 million, or $0.07 per share, for the first quarter of 2014, compared to a
net loss of $10.0 million, or $0.07 per share, for the first quarter of 2013.
Novavax revenue in the first quarter of 2014 increased 95% to $7.5 million as
compared to $3.8 million for the same period in 2013. The increase in revenue
was primarily due to the higher level of activity in the first quarter of 2014
associated with the company's Phase 1/2 clinical trial using its H7N9 candidate
and Matrix-M adjuvant and preliminary manufacturing work for its Phase 2
seasonal clinical trial under the HHS BARDA contract and the PATH amendment to
support the company's Phase 2 clinical trial in women of childbearing age.
Research and development expenses increased 57% to $14.5 million in the first
quarter of 2014, compared to $9.3 million for the same period in 2013,
primarily as a result of higher employee-related costs tied to continued growth
in support of the Company's RSV and influenza vaccine programs, as well as
Novavax AB research and development expenses. General and administrative
expenses increased 50% to $4.3 million in the first quarter of 2014 as compared
to $2.9 million for the same period in 2013, resulting from higher professional
fees and employee-related costs, as well as Novavax AB general and
administrative expenses.
As of March 31, 2014, the company had $112.8 million in cash and cash
equivalents and investments compared to $133.1 million as of December 31, 2013.
Net cash used in operating activities for the first quarter of 2014 was $20.4
million compared to $10.6 million for the same period in 2013. The increase in
cash usage from the prior year was primarily due to higher research and
development spending, including the company's RSV clinical trial and higher
employee-related costs, as well as 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 1 (877) 212-6076 (U.S. or
Canada) or 1 (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, 2014 until midnight June 7, 2014. To access the replay by telephone, dial 1
(855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode
34845350. 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 biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Additional information about Novavax is available on the company's website,
novavax.com.
Novavax Inc., 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, 2013, 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,
----------------------
2014 2013
----------------------
(unaudited)
Revenue $ 7,462 $ 3,833
----------------------
Costs and expenses:
Cost of government contracts revenue 3,021 1,712
Research and development 14,518 9,256
General and administrative 4,308 2,870
----------------------
Total costs and expenses 21,847 13,838
----------------------
Loss from operations (14,385) (10,005)
Interest income (expense), net (40) 26
Realized gains on investments 615 ?
----------------------
Loss from operations before income tax expense (13,810) (9,979)
Income tax expense ? 17
----------------------
Net loss $ (13,810) $ (9,996)
======================
Basic and diluted net loss per share $ (0.07) $ (0.07)
======================
Basic and diluted weighted average number of common 208,927 148,448
shares outstanding
======================
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
March 31, December 31,
2014 2013
--------------------------
(unaudited)
Cash and cash equivalents $ 109,921 $ 119,471
Investments 2,907 13,597
Total current assets 128,873 145,001
Working capital 115,158 126,879
Total assets 218,599 235,125
Total notes payable and capital lease obligations 2,009 2,184
Total stockholders' equity 191,060 203,234
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
News Source: NASDAQ OMX
End of Corporate News
---------------------------------------------------------------------
07.05.2014 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: Novavax, Inc.
United States
ISIN: US6700021040
End of News DGAP News-Service
---------------------------------------------------------------------
267131 07.05.2014
DGAP-News: Novavax Reports First-Quarter 2014 Financial Results
| Source: EQS Group AG