Novavax Reports Third Quarter 2017 Financial Results
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) today announced its financial results for the third quarter and
nine months ended September 30, 2017.
Third Quarter Achievements:
* Novavax initiated a Phase 1/2 clinical trial of its nanoparticle influenza
vaccine candidate with its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM))
in older adults. The trial is a randomized, observer-blinded, active
comparator-controlled trial in approximately 330 healthy older adults. The
primary objective of the trial is to assess the safety and immunogenicity of
two antigen concentrations (15 µg or 60 µg) of NanoFlu compared to a
licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
* Novavax reported that NanoFlu demonstrated superior immunogenicity and
protection compared to the market leader in a preclinical challenge study.
In a head-to-head comparison study against Fluzone HD, 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. Data from this study was published in the journal Vaccine.
* 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 is expected to grow from 16 sites in five countries in its
first season of enrollment to over 90 sites in 12 countries in 2018.
Anticipated 2017 Event:
* Announce topline data from a Phase 1/2 clinical trial of the NanoFlu vaccine
candidate in a head-to-head comparison with Fluzone HD before the end of
2017.
Summary
"We were very pleased to initiate and fully enroll the Phase 1/2 clinical trial
of our NanoFlu vaccine candidate in older adults, following impressive results
in preclinical challenge models. Given this timing, we are well positioned to
announce data from the ongoing trial before the end of the year," said Stanley
C. Erck, President and CEO. "We also continue to make significant progress in
our RSV F Vaccine program, highlighted by the continued execution of the Phase
3 Prepare trial for infants via maternal immunization. We are also evaluating
plans to conduct a clinical trial for older adults in 2018."
Financial Results for the Three and Nine Months Ended September 30, 2017
Novavax reported a net loss of $44.6 million, or $0.15 per share, for the third
quarter of 2017, compared to a net loss of $66.3 million, or $0.24 per share,
for the third quarter of 2016. For the nine months ended September 30, 2017, the
net loss was $132.9 million, or $0.47 per share, compared to a net loss of
$222.9 million, or $0.82 per share, for the same period in 2016.
Novavax revenue in the third quarter of 2017 was $8.4 million, compared to $3.2
million in the same period in 2016. This 158% increase was driven by higher
revenue recorded under the BMGF grant of $89 million.
Research and development expenses decreased 21% to $41.9 million in the third
quarter of 2017, compared to $53.0 million for the same period in 2016. The
decrease was primarily due to reduced activities related to the development of
the RSV F Vaccine for older adults, other general R&D project-related expenses
and lower employee-related costs.
General and administrative expenses decreased 40% to $8.1 million in the third
quarter of 2017, compared to $13.6 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 third quarter of 2017 and 2016 was ($3.0)
million.
As of September 30, 2017, the company had $172.6 million in cash, cash
equivalents and marketable securities, compared to $235.5 million as of December
31, 2016. Net cash used in operating activities for the first nine months of
2017 was $106.6 million, compared to $194.2 million for the 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 2479419. A replay of the conference
call will be available starting at 7:30 p.m. ET on November 7, 2017 until 7:30
pm ET on November 14, 2017. To access the replay by telephone, dial (855)
859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 2479419.
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
February 7, 2018.
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 September 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 Nine Months Ended
September 30, September 30,
----------------------------- ------------------------------
2017 2016 2017 2016
--------------- ------------- ---------------- -------------
Revenue $ 8,352 $ 3,231 $ 20,764 $ 9,954
--------------- ------------- ---------------- -------------
Expenses:
Research and
development 41,862 52,983 118,779 186,839
General and
administrative 8,118 13,556 25,911 38,183
--------------- ------------- ---------------- -------------
Total expenses 49,980 66,539 144,690 225,022
--------------- ------------- ---------------- -------------
Loss from
operations (41,628 ) (63,308 ) (123,926 ) (215,068 )
Interest
income
(expense), net (2,989 ) (2,957 ) (9,021 ) (7,756 )
Other income
(expense) 10 11 20 (33 )
--------------- ------------- ---------------- -------------
Net loss $ (44,607 ) $ (66,254 ) $ (132,927 ) $ (222,857 )
--------------- ------------- ---------------- -------------
Basic and
diluted net
loss per share $ (0.15 ) $ (0.24 ) $ (0.47 ) $ (0.82 )
--------------- ------------- ---------------- -------------
Basic and
diluted
weighted
average number
of common
shares
outstanding 296,435 271,064 284,767 270,669
--------------- ------------- ---------------- -------------
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
September 30, December 31,
2017 2016
--------------- --------------
(unaudited)
Cash and cash equivalents $ 104,245 $ 144,353
Marketable securities 68,321 91,126
Total current assets 225,995 287,830
Working capital 157,718 221,424
Total assets 334,077 394,301
Total notes payable and capital lease obligation 317,407 316,376
Total stockholders' deficit (74,151 ) (5,546 )
Contact:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor & Media 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: 07.11.2017 - 22:06 Uhr
Sprache: Deutsch
News-ID 567112
Anzahl Zeichen: 12523
contact information:
Town:
Maryland
Kategorie:
Business News
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