Novavax, Inc. (NASDAQ: NVAX), a 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, 2020.
“Novavax continues to make significant strides
towards bringing NVX-CoV2373, our COVID-19 vaccine candidate, to
market,” said Stanley C. Erck, President and Chief Executive
Officer of Novavax. “With positive efficacy results, including
against evolving variant strains, NVX-CoV2373 offers a highly
unique profile, including the ability to ship and store the vaccine
at traditional refrigerated temperatures. We believe these
attributes support emergency use authorization and have initiated
dialogue with regulators to pursue appropriate regulatory
authorization. In addition, we have secured agreements for the
delivery of approximately 300 million doses of NVX-CoV2373. In our
efforts to provide fair and equitable access to our vaccine around
the world, we are proud to partner with the Serum Institute of
India to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi
through the COVAX Facility. We continue to work tirelessly to make
final commercial preparations in advance of delivering our product
across the globe.”
Fourth Quarter 2020 and Recent
Highlights
COVID-19 Program
- Commenced regulatory
process for authorization for NVX-CoV2373
- Rolling submission initiated with
the UK Medicines and Healthcare products Regulatory Agency;
potential to file for authorization in the UK by early second
quarter 2021
- Engaged in ongoing dialogue with US
Food and Drug Administration (FDA) through submissions to our open
investigational new drug application, with potential for EUA filing
in the second quarter of 2021
- Rolling reviews initiated with:
- European Medicines Agency
- Health Canada
- Australian Therapeutic Goods
Administration
- Medsafe New Zealand
- Reported positive top-line
data from Phase 3 UK clinical trial
- Observed 95.6% efficacy against the
original strain of COVID-19 and 85.6% against the UK variant strain
- Overall primary endpoint met with a
vaccine efficacy of 89.3%
- Generally well-tolerated with a
reassuring safety profile
- Trial included 15,000 participants
between 18-84 years of age, including 27 percent over the age of
65
- Reported successful Phase
2b South Africa efficacy study
- Observed 60% efficacy for
HIV-negative portion of study population (94% of study participants
were HIV-negative)
- Demonstrated clinically meaningful
protection from South Africa escape variant, which accounted for
93% of sequenced cases
- Achieved primary efficacy endpoint
in overall trial population of 49.4%
- Trial included 4,404 participants,
including 245 medically stable, HIV-positive participants
- Supported in part by a $15 million
grant from Bill & Melinda Gates Foundation (BMGF)
- Completed enrollment in
pivotal PREVENT-19 Phase 3 efficacy trial in the US and
Mexico
- 30,000 participants enrolled in
two-to-one study design, with highly diverse population
- 20% Latin American, 12% African
American, 6% Native American, 5% Asian American and 13% adults over
the age of 65
- Interim data expected in the second
quarter of 2021 dependent on the overall COVID-19 attack rate
- Blinded crossover protocol,
ensuring all participants are provided active vaccine, submitted to
the FDA
- Trial design harmonized to align
with other Phase 3 clinical studies supported by the U.S.
government
- Ongoing clinical
development of NVX-CoV2373
- 6-month boost dose as part of Phase
1/2 clinical trial in the US and Australia
- Developing variant strain
vaccines as standalone and bivalent candidates
- Evaluation of candidates ongoing in
non-human primates
- Planning clinical evaluation of
variant vaccine candidates in mid-2021
- Secured cumulative funding
of over $2 billion to date through US government, CEPI and BMGF for
development of NVX-CoV2373
- US government funding through
partnership formerly known as Operation Warp Speed increased up to
$1.75 billion
- Coalition for Epidemic Preparedness
Innovations (CEPI) funding up to $400 million
- Increased projected global
manufacturing capacity to over 2 billion annualized doses when at
full-capacity, expected to occur in mid-2021
- Approximately one billion doses to
be manufactured by Serum Institute of India Private Limited
(SIIPL)
- Completed collaborations
for global manufacturing, commercialization and distribution of
NVX-CoV2373
- Finalized exclusive license
agreement with Takeda for the development, manufacturing and
commercialization of NVX-CoV2373
- Takeda to manufacture over 250
million doses of NVX-CoV2373 annually
- Advanced joint commitment with
SIIPL for the equitable access of 1.1 billion doses of NVX-CoV2373
for distribution by the COVAX Facility
- Reached Memorandum of Understanding
with Canadian government for plans to produce NVX-CoV2373 at the
National Research Council’s Biologics Manufacturing Centre in
Montreal
- Expanded existing partnership with
SK bioscience to include license agreement for the manufacturing
and commercialization of NVX-CoV2373
- SK bioscience to supply 40 million
doses to the Republic of Korea
- Secured agreements for
approximately 200 million doses of NVX-CoV2373
- Government of Canada to be supplied
52 million doses with an option for up to an additional 24
million
- UK government to be supplied 60
million doses
- Commonwealth of Australia to be
supplied 51 million doses with an option for up to an additional 10
million
- Government of New Zealand to be
supplied 11 million doses
- Government of Switzerland to be
supplied 6 million doses
NanoFlu™ Program
- Continued to advance NanoFlu
program, including exploration of a combined NanoFlu/NVX-CoV2373
vaccine that could be used in a post-pandemic setting
Corporate Highlights
- Appointed three individuals with
extensive pharmaceutical industry experience to Novavax’ Board of
Directors
- Gregg Alton, J.D.
- Brings extensive industry
experience, including more than 20 years at Gilead Pharmaceuticals,
serving in an array of leadership roles including Chief Executive
Officer and Chief Patient Officer
- Margie McGlynn, R. Ph.
- Brings extensive pharmaceutical
industry, vaccine and non-profit experience, including more than
two decades at Merck; held roles of increasing responsibility,
including President of Merck Vaccines and Infectious Diseases and
President, US Hospital and Specialty Products Division
- David Mott
- Brings more than three decades of
global management, board and investment experience across numerous
biopharmaceutical companies, including previously having served as
President and Chief Executive Officer of MedImmune
Financial Results for the Three and
Twelve Months Ended December 31, 2020
Novavax reported a net loss of $177.6 million,
or $2.70 per share, for the fourth quarter of 2020, compared to a
net loss of $31.8 million, or $1.13 per share, for the fourth
quarter of 2019. For the twelve months ended December 31, 2020, the
net loss was $418.3 million, or $7.27 per share, compared to a net
loss of $132.7 million, or $5.51 per share, for the same period in
2019.
Novavax revenue in the fourth quarter of 2020
was $279.7 million, compared to $8.8 million in the same period in
2019. The significant increase in revenue was comprised of revenue
for services performed under the CEPI agreement and participation
in OWS.
Research and development expenses increased to
$401.2 million in the fourth quarter of 2020, compared to $29.3
million in the same period in 2019. The increase was primarily due
to increased development activities relating to NVX-CoV2373 and
increased employee-related costs, including stock-based
compensation expense.
General and administrative expenses increased to
$61.3 million in the fourth quarter of 2020, compared to $8.2
million for the same period in 2019. The increase was primarily due
to increased employee-related costs, primarily stock-based
compensation expense, and increased professional fees to support of
our NVX-CoV2373 program.
As of December 31, 2020, Novavax had $806.4
million in cash, cash equivalents, marketable securities and
restricted cash, compared to $82.2 million as of December 31, 2019.
Net cash used in operating activities for the twelve months of 2020
was $42.5 million, compared to $136.6 million for same period in
2019.
Through utilization of At-the-market (ATM)
offerings, Novavax raised net proceeds of $428 million and $874
million during the three and twelve months of 2020, respectively.
In addition, in the second quarter of 2020, Novavax received gross
proceeds of $200 million upon entering into an agreement to sell
Series A Convertible preferred stock, convertible into 4,388,850
shares of common stock, to an investment fund affiliated with RA
Capital Management (RA Capital) in a private placement. There
shares were converted to common stock in the fourth quarter of
2020.
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 3797013. A replay of the conference call will be available
starting at 7:30 p.m. ET on March 1, 2021 until 7:30 p.m. ET on
March 8, 2021. To access the replay by telephone, dial (855)
859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 3797013.
A webcast of the conference call can also be
accessed on the Novavax website at novavax.com/events. A replay of
the webcast will be available on the Novavax website until June 1,
2021.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate
engineered from the genetic sequence of SARS-CoV-2, the virus that
causes COVID-19 disease. NVX-CoV2373 was created using Novavax’
recombinant nanoparticle technology to generate antigen derived
from the coronavirus spike (S) protein and is adjuvanted with
Novavax’ patented saponin-based Matrix-M™ to enhance the immune
response and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 contains purified protein antigen and can neither
replicate, nor can it cause COVID-19. In preclinical studies,
NVX-CoV2373 induced antibodies that block binding of the spike
protein to cellular receptors and provided protection from
infection and disease. It was generally well-tolerated and elicited
robust antibody response numerically superior to that seen in human
convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is
currently being evaluated in two pivotal Phase 3 trials: a trial in
the U.K that demonstrated 89.3 percent overall efficacy
and 95.6 percent against the original strain in a post-hoc
analysis, and the PREVENT-19 trial in
the U.S. and Mexico that began in December. It
is also being tested in two ongoing Phase 2 studies that began in
August: A Phase 2b trial in South Africa that
demonstrated 50-60 percent efficacy against newly emerging escape
variants, and a Phase 1/2 continuation in
the U.S. and Australia.
About NanoFlu™
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.
About Matrix-M™
Novavax’ patented saponin-based Matrix-M™
adjuvant 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, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology
company that promotes improved health globally through the
discovery, development and commercialization of innovative vaccines
to prevent serious infectious diseases. The company’s proprietary
recombinant technology platform combines the power and speed of
genetic engineering to efficiently produce highly immunogenic
nanoparticles designed to address urgent global health needs.
Novavax is conducting late-stage clinical trials for NVX-CoV2373,
its vaccine candidate against SARS-CoV-2, the virus that causes
COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle
vaccine, met all primary objectives in its pivotal Phase 3 clinical
trial in older adults and will be advanced for regulatory
submission. Both vaccine candidates incorporate Novavax’
proprietary saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing antibodies.
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, 2020, as filed with the Securities
and Exchange Commission (SEC). We caution investors not to place
considerable reliance on 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 EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
279,659 |
|
|
$ |
8,816 |
|
|
$ |
475,598 |
|
|
$ |
18,662 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
401,199 |
|
|
29,341 |
|
|
747,027 |
|
|
113,842 |
|
Gain on sale of assets |
-- |
|
|
-- |
|
|
-- |
|
|
(9,016 |
) |
General and administrative |
61,313 |
|
|
8,180 |
|
|
145,290 |
|
|
34,417 |
|
Total expenses |
462,512 |
|
|
37,521 |
|
|
892,317 |
|
|
139,243 |
|
Loss from
operations |
(182,853 |
) |
|
(28,705 |
) |
|
(416,719 |
) |
|
(120,581 |
) |
Interest
income (expense), net |
(3,737 |
) |
|
(3,127 |
) |
|
(14,131 |
) |
|
(12,100 |
) |
Other income
(expense) |
9,026 |
|
|
2 |
|
|
12,591 |
|
|
(13 |
) |
Net
loss |
$ |
(177,564 |
) |
|
$ |
(31,830 |
) |
|
$ |
(418,259 |
) |
|
$ |
(132,694 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
$ |
(2.70 |
) |
|
$ |
(1.13 |
) |
|
$ |
(7.27 |
) |
|
$ |
(5.51 |
) |
Basic and
diluted weighted average number of common shares outstanding |
65,725 |
|
|
28,063 |
|
|
57,554 |
|
|
24,100 |
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA(in thousands)
|
December 31,2020 |
|
December 31,2019 |
|
|
|
|
Cash and cash equivalents |
$ |
553,398 |
|
$ |
78,823 |
|
Marketable securities |
|
157,649 |
|
|
-- |
|
Total restricted cash |
|
95,340 |
|
|
3,357 |
|
Total current assets |
|
1,248,203 |
|
|
97,247 |
|
Working capital |
|
668,531 |
|
|
71,452 |
|
Total assets |
|
1,582,479 |
|
|
172,957 |
|
Notes payable |
|
322,035 |
|
|
320,611 |
|
Total stockholders’ equity
(deficit) |
|
627,209 |
|
|
(186,017 |
) |
|
|
|
|
|
|
|
Contacts:
InvestorsNovavax, Inc.Erika Schultz |
240-268-2022ir@novavax.com
Solebury TroutJennifer Porcelli |
617-974-8659jporcelli@soleburytrout.com
MediaAmy Speak | 617-420-2461 Laura Keenan | 410-419-5755
media@novavax.com
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