Novavax Reports Second Quarter 2017 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX)
today announced its financial results for the second quarter and six months
ended June 30, 2017.
Second Quarter and Subsequent Achievements:
* Novavax' nanoparticle flu vaccine demonstrates superior immunogenicity and
protection compared to market leader in preclinical challenge studies. In
head-to-head comparison studies against Fluzone® High-Dose, Novavax'
nanoparticle influenza vaccine with our proprietary Matrix-M(TM) adjuvant
(NanoFlu) demonstrated significantly stronger and broader immune responses
against matched and unmatched influenza strains, including a series of
"drifted" strains evolved over more than a decade of influenza seasons.
NanoFlu was also protective in an established challenge model against both a
matched and a ten-year old unmatched strain. Further details will be
published in the near future in a peer-reviewed journal and presented at
scientific conferences.
* Topline data from Phase 2 older adult safety and immunogenicity trial (E-
205) demonstrated the benefit of adjuvanted formulations and two-dose
regimens. Immunogenicity outcomes indicate both Matrix-M and aluminum
phosphate adjuvants significantly increased the magnitude, duration and
quality of the immune response relative to the RSV F antigen alone. All
formulations and regimens were safe and well-tolerated.
* The Company announced the path forward for an adjuvanted RSV F protein
recombinant nanoparticle vaccine (RSV F Vaccine) in older adults with plans
to initiate a Phase 2 efficacy trial in 2018. This approach is driven by an
observed 61% reduction in hospitalizations due to COPD exacerbations.
* The Prepare(TM) clinical trial for infants via maternal immunization,
supported by an $89 million grant from the Bill and Melinda Gates Foundation
(BMGF), accelerated into the third global season of enrollment. Prepare's
global footprint has grown from 16 sites in five countries in its first
season of enrollment to 80 sites in 11 countries.
* Data from the second of two Phase 2 trials of its RSV F Vaccine candidate
confirmed an overall reduction of infection of >50% in women of childbearing
age, published in the journal Vaccine.
Anticipated 2017 Event:
* Initiation of a Phase 1/2 clinical trial of the Company's NanoFlu vaccine
candidate in a head-to-head comparison to Fluzone High-Dose. Data from this
trial should be available in the fourth quarter of 2017.
Summary
"Novavax has demonstrated considerable progress in our RSV F Vaccine program,
highlighted by the continued strong execution of the Prepare trial, and the data
from our recent trial in older adults, which confirmed the ability of the
vaccine to generate robust immune responses and provided us with a development
path forward," said Stanley C. Erck, President and CEO. "We are also excited by
the recent preclinical results of our nanoparticle influenza vaccine and look
forward to Phase 1/2 clinical data in the fourth quarter of this year."
Financial Results for the Three and Six Months Ended June 30, 2017
Novavax reported a net loss of $44.5 million, or $0.16 per share, for the second
quarter of 2017, compared to a net loss of $79.4 million, or $0.29 per share,
for the second quarter of 2016. For the six months ended June 30, 2017, the net
loss was $88.3 million, or $0.32 per share, compared to a net loss of $156.6
million, or $0.58 per share, for the same period in 2016.
Novavax revenue in the second quarter of 2017 increased 169% to $6.7 million,
compared to $2.5 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 40% to $39.3 million in the second
quarter of 2017, compared to $64.9 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 37% to $8.9 million in the second
quarter of 2017, compared to $14.1 million for the same period in 2016. The
decrease was primarily due to lower professional fees for pre-commercialization
activities and lower employee-related costs.
Interest income (expense), net for the second quarter of 2017 was ($3.0)
million, compared to ($2.8) million for the same period in 2016.
As of June 30, 2017, the company had $187.3 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 six months of 2017 was $69.4
million, compared to $131.9 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 overall 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 15614203. A replay of the conference
call will be available starting at 7:30 p.m. ET on August 8, 2017 until 7:30 pm
ET on August 15, 2017. To access the replay by telephone, dial (855) 859-2056
(Domestic) or (404) 537-3406 (International) and use passcode 15614203.
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
November 8, 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.
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 Quarterly Report on
Form 10-Q for the period ended June 30, 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.
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------------ -----------------------------
2017 2016 2017 2016
--------------- -------------- --------------- -------------
Revenue $ 6,732 $ 2,505 $ 12,412 $ 6,723
--------------- -------------- --------------- -------------
Expenses:
Research and
development 39,263 64,904 76,916 133,856
General and
administrative 8,940 14,099 17,793 24,627
--------------- -------------- --------------- -------------
Total expenses 48,203 79,003 94,709 158,483
--------------- -------------- --------------- -------------
Loss from
operations (41,471 ) (76,498 ) (82,297 ) (151,760 )
Interest income
(expense), net (2,993 ) (2,842 ) (6,032 ) (4,799 )
Other income
(expense) (1 ) (11 ) 10 (44 )
--------------- -------------- --------------- -------------
Net loss $ (44,465 ) $ (79,351 ) $ (88,319 ) $ (156,603 )
--------------- -------------- --------------- -------------
Basic and
diluted net loss
per share $ (0.16 ) $ (0.29 ) $ (0.32 ) $ (0.58 )
--------------- -------------- --------------- -------------
Basic and
diluted weighted
average
number of common
shares
outstanding 283,444 270,760 278,836 270,469
--------------- -------------- --------------- -------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
June 30, December 31,
2017 2016
--------------- --------------
(unaudited)
Cash and cash equivalents $ 75,793 $ 144,353
Marketable securities 111,515 91,126
Total current assets 236,683 287,830
Working capital 169,892 221,424
Total assets 355,706 394,301
Total notes payable and capital lease obligation 317,051 316,376
Total stockholders' deficit (59,062 ) (5,546 )
Contact:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
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
Maggie Beller
david.schull(at)russopartnersllc.com
maggie.beller(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: 08.08.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 555753
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contact information:
Town:
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Kategorie:
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