Novavax Reports First Quarter 2017 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., May 08, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX)
today announced its financial results for the first quarter ended March
31, 2017.
First Quarter Achievements:
* Enrollment continued during the second global season in the RSV Phase 3
Prepare(TM) clinical trial for infants via maternal immunization. Enrollment
in the first quarter of 2017 transitioned from the northern hemisphere to
southern hemisphere sites in Argentina, Australia, Chile, New Zealand and
South Africa. The second season of enrollment has benefitted greatly from
the establishment of the operational infrastructure and experience from the
first global season, resulting in material increases in enrollment and
enhanced momentum as we move towards the third global season of enrollment.
* 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.
Anticipated 2017 Events:
* Announce top-line data from the Phase 2 safety and immunogenicity clinical
trial of the RSV F vaccine in older adults in the next 90 days.
* File revised study documents and conduct an informational analysis of the
Prepare trial that would provide an indication of the RSV F Vaccine's
potential efficacy against the trial's primary endpoint before the end of
the year.
* Initiate a Phase 1 clinical trial of the Company's recombinant seasonal
influenza vaccine candidate before the end of the year.
* Initiate a Phase 1 clinical trial of the Company's Zika vaccine candidate
before the end of the year.
Summary
"We continued to make significant progress in the execution of our two key
clinical trials of our RSV F vaccine for both infant via maternal immunization
and in older adults. We look forward to reporting important clinical data from
our older adult trial in the next 90 days. We've also been in discussion with
the FDA about conducting an informational analysis of the Prepare trial that
would provide an indication of our vaccine's potential efficacy. From these
discussions, we believe we can conduct this analysis in late 2017," said Stanley
C. Erck, President and CEO. "In addition, we are seeing the continued adoption
and use of our proprietary adjuvant, Matrix-M, in a number of internal and
partnered programs."
Financial Results for the Three Months Ended March 31, 2017
Novavax reported a net loss of $43.9 million, or $0.16 per share, for the first
quarter of 2017, compared to a net loss of $77.3 million, or $0.29 per share,
for the first quarter of 2016.
Novavax revenue in the first quarter of 2017 increased 35% to $5.7 million,
compared to $4.2 million for the same period in 2016, primarily due to increased
revenue recorded under the BMGF grant relating to our ongoing Prepare clinical
trial.
Research and development expenses decreased 45% to $37.7 million in the first
quarter of 2017, compared to $69.0 million for the same period in 2016. The
decrease was primarily due to reduced costs associated with the clinical trials
and development activities of our RSV F Vaccine and lower employee-related
costs.
General and administrative expenses decreased 16% to $8.9 million in the first
quarter of 2017, compared to $10.5 million for the same period in 2016. The
decrease was primarily due to lower professional fees for pre-commercialization
activities.
Interest income (expense), net for the first quarter of 2017 was ($3.0) million,
compared to ($1.9) million for the same period in 2016.
As of March 31, 2017, the company had $211.2 million in cash and cash
equivalents and marketable securities compared to $235.5 million as of December
31, 2016. Net cash used in operating activities for the first quarter of 2017
was $38.6 million, compared to $69.8 million for same period in 2016. The
decrease in cash usage was primarily due to decreased costs relating to our RSV
F Vaccine and lower employee-related costs.
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 15607801. A replay of the conference
call will be available starting at 7:30 p.m. ET on May 8, 2017 until 7:30 pm ET
on May 15, 2017. To access the replay by telephone, dial (855) 859-2056
(Domestic) or (404) 537-3406 (International) and use passcode 15607801.
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 webcast will be
available through the "Investor Info"/"Events" tab on the Novavax website until
July 3, 2017.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology 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.
About RSV
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory
tract infections and the leading viral cause of severe lower respiratory tract
disease in infants and young children worldwide, with estimated annual infection
and mortality rates of 64 million and 160,000, respectively.(1) In the U.S., RSV
is the leading cause of hospitalization of infants, and globally, is second only
to malaria as a cause of death in children under 1 year of age.(2 )(3) Despite
the induction of post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common. Currently, there is no approved RSV vaccine
available.(4 )(5)
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, 2016 and the Report on Form 10-Q
for the period ended March 31, 2017, both 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.
(1) Nair, H. et al. Global burden of acute lower respiratory infections due to
respiratory syncytial virus in young children: a systematic review and meta-
analysis. Lancet, 2010; 375: 1545-1555.
(2) Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations
Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
(3) Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv
(4) Glezen, W.P. et al. Risk of primary infection and reinfection with
respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
(5) Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody
transfer in guinea pigs. Vaccine, 2015; In
press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
Three Months Ended
March 31,
--------------------------------
2017 2016
---------------- ---------------
Revenue $ 5,680 $ 4,218
---------------- ---------------
Expenses:
Research and development 37,654 68,952
General and administrative 8,852 10,528
---------------- ---------------
Total expenses 46,506 79,480
---------------- ---------------
Loss from operations (40,826 ) (75,262 )
Interest income (expense), net (3,039 ) (1,957 )
Other income (expense) 11 (33 )
---------------- ---------------
Net loss $ (43,854 ) $ (77,252 )
---------------- ---------------
Basic and diluted net loss per share $ (0.16 ) $ (0.29 )
---------------- ---------------
Basic and diluted weighted average
number of common shares outstanding
274,178 270,179
---------------- ---------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
March 31, December
2017 31, 2016
--------------- --------------
(unaudited)
Cash and cash equivalents $ 95,847 $ 144,353
Marketable securities 115,331 91,126
Total current assets 258,449 287,830
Working capital 201,951 221,424
Total assets 361,504 394,301
Total notes payable and capital lease obligation
316,714 316,376
Total stockholders' deficit (29,099 ) (5,546 )
Contact:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
ir(at)novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford(at)westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull(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: 08.05.2017 - 22:12 Uhr
Sprache: Deutsch
News-ID 541033
Anzahl Zeichen: 13652
contact information:
Town:
Maryland
Kategorie:
Business News
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