Novavax Reports Third Quarter 2016 Financial Results
(Thomson Reuters ONE) -
* Announces Corporate Restructuring and Cost Savings
* Highlights Strategic Focus and Development Activities for 2017
GAITHERSBURG, Md., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) today announced its financial results for the third quarter and
nine months ended September 30, 2016, in conjunction with its Investor and
Analyst Day update.
The Company presented a restructuring plan designed to meet the following key
objectives:
* Prioritize development activities to achieve clinical data events within
2017;
* Reduce cash burn, extend financial horizon and minimize near-term dilution;
and
* Maintain operational core competencies to execute development plans.
The restructuring includes an immediate reduction in workforce of approximately
30%. The Company expects to incur one-time restructuring costs of approximately
$3 million to $4 million, including severance expenses, in the fourth quarter of
2016. In addition, management has initiated expense reduction measures relating
to pre-commercialization activities, capital equipment investments, project
specific and general research and development, and general and administrative
expenses. As a result of the restructuring, Novavax estimates a reduction in
cash burn of $70 million to $100 million in 2017 relative to 2016.
The restructuring plan was engineered to decrease cash burn and support the
Company's development priorities through the balance of 2016 and in 2017,
specifically:
* Continued execution of the Phase 3 Prepare(TM) clinical trial to prevent RSV
in infants via maternal immunization at multiple international sites.
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 a minimum of the first 90 days of
life. Prepare is supported by a grant of up to $89 million from the Bill &
Melinda Gates Foundation (BMGF);
* Initiation of a randomized, observer-blinded, multi-arm, dose-ranging Phase
2 clinical trial, in one and two dose formulations, both with and without
adjuvants, of its RSV F Vaccine in older adults (60 years of age and older).
The trial will evaluate safety and immunogenicity of these formulations in
older adults as measured by serum microneutralization titers against RSV/A
and RSV/B, palivizumab competing antibodies ("PCA") and anti-F IgG; and
* Initiation of a Phase 1 clinical trial of its Zika virus envelope dimer
nanoparticle vaccine candidate (ZIKV EnvD Vaccine) in 2017.
Summary
"We have identified a clear path forward that we expect will provide us with
important clinical data throughout 2017 and protect liquidity," said Stanley C.
Erck, President and CEO. "We have the balance sheet to execute this plan. We
have resized our organization consistent with this plan and look forward to
reporting data from these programs in 2017. We continue to have great confidence
in our platform technology, our RSV F Vaccine and the significant commercial
opportunity for an RSV vaccine for infants via maternal immunization."
Financial Results for the Three and Nine Months Ended September 30, 2016
Novavax reported a net loss of $66.3 million, or $0.24 per share, for the third
quarter of 2016, compared to a net loss of $33.1 million, or $0.12 per share,
for the third quarter of 2015. For the nine months ended September 30, 2016, the
net loss was $222.9 million, or $0.82 per share, compared to a net loss of $78.1
million, or $0.30 per share, for the same period in 2015.
Novavax revenue in the third quarter of 2016 decreased 50% to $3.2 million,
compared to $6.5 million for the same period in 2015. Lower revenue under the
HHS BARDA contract of $6.2 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 September 30, 2016, primarily resulting from the natural expiration
of the HHS BARDA contract, as compared to the same period in 2015. This decrease
in HHS BARDA revenue was partially offset by $2.6 million in revenue recorded
under the BMGF grant relating to our ongoing Prepare clinical trial.
Research and development expenses increased 73% to $53.0 million in the third
quarter of 2016, compared to $30.7 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 50% to $13.6 million in the third
quarter of 2016, compared to $9.1 million for the same period in 2015. The
increase was primarily due to higher employee-related costs and professional
fees for pre-commercialization activities, as compared to the same period in
2015.
Interest income (expense), net for the third quarter of 2016 includes $3.4
million of interest expense relating the Company's Convertible Senior Notes
offering in the first quarter of 2016.
As of September 30, 2016, the company had $300.3 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 nine months of
2016 was $194.2 million, compared to $71.3 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 10126707. 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
November 9, 2016 until midnight November 16, 2016. To access the replay by
telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and
use passcode 10126707. 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, as well as the effectiveness, and expected
costs and savings, and the timing of such costs and savings, associated with the
implementation, of Novavax' recently announced plan to restructure its
operations, 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)
Three Months Ended September Nine Months Ended September
30, 30,
------------------------------ -------------------------------
2016 2015 2016 2015
-------------- --------------- ---------------- --------------
(unaudited) (unaudited)
Revenue $ 3,231 $ 6,525 $ 9,954 $ 30,397
-------------- --------------- ---------------- --------------
Expenses:
Research and
development 52,983 30,664 186,839 86,740
General and
administrative 13,556 9,060 38,183 21,991
-------------- --------------- ---------------- --------------
Total expenses 66,539 39,724 225,022 108,731
-------------- --------------- ---------------- --------------
Loss from
operations (63,308 ) (33,199 ) (215,068 ) (78,334 )
Interest income
(expense), net (2,957 ) 130 (7,756 ) 324
Other income
(expense) 11 (51 ) (33 ) (121 )
-------------- --------------- ---------------- --------------
Net loss $ (66,254 ) $ (33,120 ) $ (222,857 ) $ (78,131 )
-------------- --------------- ---------------- --------------
Basic and
diluted net loss
per share $ (0.24 ) $ (0.12 ) $ (0.82 ) $ (0.30 )
-------------- --------------- ---------------- --------------
Basic and
diluted weighted
average number
of shares
outstanding 271,064 269,554 270,669 259,703
-------------- --------------- ---------------- --------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
September December
30, 2016 31, 2015
---------------- --------------
(unaudited)
Cash and cash equivalents $ 119,948 $ 93,108
Marketable securities 180,335 137,548
Total current assets 353,905 287,257
Working capital 278,221 210,763
Total assets 459,626 386,038
Total notes payable and capital lease 316,083 503
obligations
Total stockholders' equity 49,784 292,669
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
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 09.11.2016 - 22:05 Uhr
Sprache: Deutsch
News-ID 506054
Anzahl Zeichen: 14042
contact information:
Town:
Maryland
Kategorie:
Business News
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