Novavax Reports Second Quarter 2017 Financial Results
August 08 2017 - 4:05PM
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™ 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™ 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™ 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 |
) |
Contact:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor Relations
ir@novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
Maggie Beller
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
212-845-4271
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