Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced its financial results and operational
highlights for the fourth quarter and twelve months ended December
31, 2019.
“We remain on track to announce top-line results
from our pivotal Phase 3 clinical trial for NanoFlu by the end of
this month. Positive clinical data from this trial would support a
subsequent U.S. BLA using the FDA’s accelerated approval pathway,”
said Stanley C. Erck, President and Chief Executive Officer of
Novavax. “We continue to make progress towards partnering our
ResVax program and recently announced progress in our efforts to
develop a vaccine against COVID-19, with the goal of moving one or
more optimized COVID- 19 candidates into the clinic by the end
of this spring.”
Fourth Quarter 2019 and Subsequent
Operational Highlights
NanoFlu™ Program
- Results of the pivotal Phase 3 clinical trial for NanoFlu,
Novavax’ recombinant quadrivalent seasonal influenza vaccine
candidate, are expected later this month. The trial includes 2,652
healthy older adults across 19 U.S. clinical sites. The primary
objective of the randomized, observer-blinded, active-controlled
trial is to demonstrate non-inferior immunogenicity as measured by
hemagglutination inhibition (HAI) titers of vaccine homologous
influenza strains and safety compared against a licensed vaccine,
Fluzone® Quadrivalent.
- Positive top-line results from this Phase 3 clinical trial
would support a subsequent U.S. biologics license application (BLA)
and licensure of NanoFlu using the U.S. Food and Drug
Administration’s (FDA) accelerated approval pathway. In addition,
in January 2020, the FDA granted Fast Track designation for
NanoFlu.
COVID-19 Program
- Novavax recently announced that the Coalition for Epidemic
Preparedness Innovations (CEPI) awarded an initial funding of $4
million to support its effort to develop a COVID-19 vaccine. CEPI
and Novavax are having ongoing discussions on additional funding
from CEPI to address Novavax’ costs through Phase 1.
- Novavax began efforts to develop a novel vaccine to protect
against COVID-19 in January. Novavax has produced and is currently
assessing multiple nanoparticle vaccine candidates in animal models
prior to advancing to clinical trials. Initiation of Phase I
clinical testing is expected in May or June 2020. Novavax expects
to utilize its proprietary Matrix-M™ adjuvant with its COVID-19
vaccine candidate to enhance immune responses.
ResVax™ Program
- Novavax is continuing its discussions with both global
regulatory authorities and potential partners to explore the
opportunity to bring ResVax to market.
Matrix-M Partnership
- Earlier today, Novavax announced a commercial license agreement
related to its Matrix-M vaccine adjuvant. Matrix-M is a key
component of Serum Institute of India’s malaria vaccine candidate,
which it licensed from Jenner Institute at Oxford University. The
vaccine candidate is currently in a Phase 2b clinical trial being
conducted in Burkina Faso with top-line data expected in the second
quarter of 2020.
Corporate
- Through utilization of At-the-market (ATM) offerings during the
fourth quarter of 2019, Novavax raised net proceeds of $30 million.
For the twelve months of 2019, Novavax raised net proceeds of $97
million. Subsequent to year-end, through March 6, 2020, Novavax
raised additional net proceeds of $156 million.
Financial Results for the Three and
Twelve Months Ended December 31, 2019
Share and per share data have been restated to
reflect the reverse stock split that was completed in May 2019.
Novavax reported a net loss of $31.8 million, or
$1.13 per share, for the fourth quarter of 2019, compared to a net
loss of $49.3 million, or $2.57 per share, for the fourth quarter
of 2018. For the twelve months ended December 31, 2019, the net
loss was $132.7 million, or $5.51 per share, compared to a net loss
of $184.7 million, or $9.99 per share, for the same period in
2018.
Novavax revenue in the fourth quarter of 2019
was $8.8 million, compared to $6.1 million in the same period in
2018. This 44% increase was driven by $7.5 million in revenue for
the recovery of additional costs under the closeout of the HHS
BARDA contract, partially offset by lower revenue from the
completion of enrollment of participants in the Prepare™ trial in
second quarter of 2018.
Research and development expenses decreased 32%
to $29.3 million in the fourth quarter of 2019, compared to $43.4
million in the same period in 2018. This decrease was primarily due
to decreased development activities of ResVax, lower
employee-related costs and other cost savings due to the Catalent
transaction, partially offset by NanoFlu’s Phase 3 clinical trial
and development activities.
General and administrative expenses decreased to
$8.2 million in the fourth quarter of 2019, compared to $9.2
million for the same period in 2018.
Interest income (expense), net for the fourth
quarter of 2019 was ($3.1) million, compared to ($2.8) million for
the same period of 2018.
As of December 31, 2019, Novavax had $82.2
million in cash, cash equivalents, marketable securities and
restricted cash, compared to $103.9 million as of December 31,
2018. Net cash used in operating activities for the twelve months
of 2019 was $136.6 million, compared to $184.8 million for same
period in 2018.
Conference Call
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call
are (877) 212-6076 (Domestic) or (707) 287-9331 (International),
passcode 5695528. A replay of the conference call will be available
starting at 7:30 p.m. ET on March 11, 2020 until 7:30 p.m. ET on
March 18, 2020. To access the replay by telephone, dial (855)
859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 5695528.
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 on the
Novavax website until June 11, 2020.
About NanoFlu™ and
Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine produced by Novavax in its
SF9 insect cell baculovirus system. NanoFlu uses HA amino acid
protein sequences that are the same as the recommended wild-type
circulating virus HA sequences. NanoFlu contains Novavax’ patented
saponin-based Matrix-M adjuvant, which has demonstrated a potent
and well-tolerated effect by stimulating the entry of
antigen-presenting cells into the injection site and enhancing
antigen presentation in local lymph nodes. Top-line data from
Novavax’ ongoing Phase 3 clinical trial of NanoFlu is expected late
in the first quarter of 2020.
About COVID-19
A new strain of coronavirus first appeared in
late 2019 in China before beginning its rapid spread across the
globe. The disease, named COVID-19, continues to cause severe
pneumonia-like symptoms in many of those infected. Coronaviruses,
so named for their “crown-like” appearance, are a large family of
viruses that spread from animals to humans and include diseases
such as Middle East Respiratory Syndrome (MERS) and Severe Acute
Respiratory Syndrome (SARS) in addition to COVID-19. While much
remains unknown about the new coronavirus, it is known that the
virus can spread via human-to-human transmission before any
symptoms appear.
About Novavax
Novavax, Inc. (Nasdaq:NVAX), is a late-stage
biotechnology company that drives improved health globally through
the discovery, development, and commercialization of innovative
vaccines to prevent serious infectious diseases. NanoFlu™, its
quadrivalent influenza nanoparticle vaccine, is currently in a
pivotal Phase 3 clinical trial to address key factors that can lead
to the poor effectiveness of currently approved flu vaccines.
ResVax™, its RSV vaccine for infants via maternal immunization, is
the only vaccine in a Phase 3 clinical program and is designed to
prevent severe lower respiratory tract infection, which is the
second leading cause of death in children under one year of age
worldwide. Novavax is a leading innovator of recombinant vaccines;
its proprietary recombinant technology platform combines the power
and speed of genetic engineering to efficiently produce a new class
of highly immunogenic nanoparticles addressing urgent global health
needs.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
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, 2019, 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
|
|
December 31, |
|
December 31 |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
| |
|
|
|
|
|
|
|
| Revenue |
$ |
8,816 |
|
|
$ |
6,127 |
|
|
$ |
18,662 |
|
|
$ |
34,288 |
|
|
|
|
|
|
|
|
|
|
|
|
| Expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
29,341 |
|
|
|
43,415 |
|
|
|
113,842 |
|
|
|
173,797 |
|
|
|
Gain on Catalent
transaction |
|
-- |
|
|
|
-- |
|
|
|
(9,016 |
) |
|
|
-- |
|
|
|
General and
administrative |
|
8,180 |
|
|
|
9,224 |
|
|
|
34,417 |
|
|
|
34,409 |
|
|
|
|
Total expenses |
|
37,521 |
|
|
|
52,639 |
|
|
|
139,243 |
|
|
|
208,206 |
|
| Loss from
operations |
|
(28,705 |
) |
|
|
(46,512 |
) |
|
|
(120,581 |
) |
|
|
(173,918 |
) |
| Interest income
(expense), net |
|
(3,127 |
) |
|
|
(2,819 |
) |
|
|
(12,100 |
) |
|
|
(10,938 |
) |
| Other income
(expense) |
|
2 |
|
|
|
(3 |
) |
|
|
(13 |
) |
|
|
108 |
|
| Net loss |
$ |
(31,830 |
) |
|
$ |
(49,334 |
) |
|
$ |
(132,694 |
) |
|
$ |
(184,748 |
) |
|
|
|
|
|
|
|
|
|
|
|
| Basic and diluted net
loss per share |
$ |
(1.13 |
) |
|
$ |
(2.57 |
) |
|
$ |
(5.51 |
) |
|
$ |
(9.99 |
) |
| Basic and diluted
weighted average |
|
|
|
|
|
|
|
|
|
number of common
shares outstanding |
|
28,063 |
|
|
|
19,159 |
|
|
|
24,100 |
|
|
|
18,488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA (in thousands)
| |
December 31, 2019 |
|
December 31, 2018 |
| |
|
|
|
|
Cash and cash equivalents |
$ |
78,823 |
|
|
$ |
70,154 |
|
| Marketable securities |
|
-- |
|
|
|
21,980 |
|
| Total restricted cash |
|
3,357 |
|
|
|
11,805 |
|
| Total current assets |
|
97,247 |
|
|
|
119,276 |
|
| Working capital |
|
71,452 |
|
|
|
73,737 |
|
| Total assets |
|
172,957 |
|
|
|
207,978 |
|
| Notes payable |
|
320,611 |
|
|
|
319,187 |
|
| Total stockholders’ deficit |
|
(186,017 |
) |
|
|
(167,935 |
) |
Contacts:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com240-268-2022
WestwickeJohn
Woolfordjohn.woolford@westwicke.com 443-213-0506
MediaBrandzone/COGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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