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,
2017 |
|
December 31,
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 |
) |