GAITHERSBURG, Md., Feb. 28, 2022 /PRNewswire/ --
- NVX-CoV2373 is the first protein-based COVID-19 vaccine
authorized in multiple major markets around the world, including
the European Union, Australia,
Canada, and Great Britain; authorizations granted by 12
regulatory agencies and emergency use listing from the WHO
- Additional filings for authorization under review, including
in the United States
- Initiated vaccine shipments globally, with doses
administered in the European Union, Australia, Indonesia and South
Korea
- Expanded clinical body of evidence for NVX-CoV2373 across
several studies, including:
-
- 82.5% overall protection against all COVID-19 infection in
extended analysis of UK Phase 3 study
- 82% efficacy against Delta variant in PREVENT-19 pediatric
expansion for adolescents aged 12 through 17
- Broad cross-reactivity against Omicron and other variants
following a 2-dose primary series, with increased immune responses
after 6-month booster dose
- Developed Omicron-specific vaccine; GMP manufacturing
ongoing with delivery expected toward the end of first quarter of
2022
- Full year 2022 total revenue guidance of between
$4 billion and $5 billion
- Company to host conference call today at 4:30 p.m. ET
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated
to developing and commercializing 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, 2021.
"NVX-CoV2373 has now received regulatory authorizations
globally, representing the potential to reach more than six billion
lives. We are now delivering our vaccine around the world, with
immunizations already happening in the European Union, Asia and Australia to meet the continued need to
achieve high vaccination rates through primary immunization,
boosting and protection of pediatric age groups," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "We also remain focused on expanding access to
our vaccine through additional regulatory filings and ongoing
research to add to our robust body of clinical data. We are
confident in NVX-CoV2373's potential as a vital vaccine option due
to its reassuring safety profile and demonstrated efficacy against
variants with the benefits of refrigerator-stable storage."
Fourth Quarter 2021 and Recent Highlights
Achieved Multiple Regulatory Authorizations Globally for
COVID-19 Vaccine
- Nuvaxovid™ was granted authorization (emergency,
provisional, interim conditional or emergency use listing) in
Great Britain, the European Union,
the World Health Organization (WHO), Canada, Australia, United
Arab Emirates, Singapore,
and New Zealand; received
Biologics License Application approval in South Korea with our partner, SK
bioscience
- Covovax™ was granted emergency use authorization in
India, Indonesia, Philippines, Bangladesh, and emergency use listing from the
WHO with our partner, Serum Institute of India (SII)
Completed Multiple Regulatory Submissions Globally for
COVID-19 Vaccine
- Completed regulatory submissions for authorization for
NVX-CoV2373 in the U.S. and Switzerland
- SII completed submission to South
Africa, for NVX-CoV2373 to be marketed as Covovax
- Takeda Pharmaceutical Company Limited, our partner, completed
submission to Japan for a New Drug
Application
COVID-19 Vaccine Advanced Purchase
Agreement
- Executed advance purchase agreement (APA) with Israel's Ministry of Health to supply a
minimum of 5 million vaccine doses
-
- Option to purchase an additional 5 million doses
COVID-19 Vaccine Manufacturing, Supply and
Distribution
- Built manufacturing and robust supply network to support over 2
billion annual doses of capacity and initiated distribution of
NVX-CoV2373 to begin fulfillment of our commitments
-
- Expanded partnership with SII through new supply agreement
- Reserved significant additional manufacturing capacity with SK
bioscience to produce antigen, and SK bioscience acquired
non-exclusive rights to sell to governments in Thailand and Vietnam
- Entered into a contract manufacturing agreement with Mabion for
the large-scale manufacturing of NVX-CoV2373 through 2026
COVID-19 Vaccine Clinical Development
- Announced data from extended analysis of our UK Phase 3 study
demonstrating ongoing durability of protection against infection
and disease
-
- 82.5% vaccine efficacy in protection against all COVID-19
infection, both symptomatic and asymptomatic, as measured by PCR+
or anti-N seroconversion
- 82.7% overall vaccine efficacy against disease over a 6-month
data collection period (median of 101 days of surveillance)
- 100% vaccine efficacy against severe disease
- Announced data from PREVENT-19 Phase 3 pediatric expansion in
adolescents aged 12 through 17, achieving primary effectiveness
endpoint and comparability to adult population
-
- Adolescent neutralization responses ~1.5-fold higher than
adults
- 82% clinical efficacy against Delta variant
- IgG and functional immune responses against variants were
higher than in adults
- Generally well-tolerated with no safety signals
- Expect to supplement global regulatory filings in the first
quarter of 2022
- Expect to initiate a pediatric study in younger children in the
second quarter of 2022
- Initiated PREVENT-19 Phase 3 booster study to evaluate safety
and efficacy of a third dose of NVX-CoV2373
- Heterologous boosting data announced in COV-Boost Phase 2
Study, with NVX-CoV2373 demonstrating its ability to serve as a
well-tolerated third dose to boost immune levels
- Announced immunologic cross-reactivity data from vaccine
booster and adolescent studies to highlight potential utility of
NVX-CoV2373 against Omicron variant (B.1.1.529)
-
- Demonstrated broad IgG antibody cross-reactivity against
Omicron and other circulating variants with primary 2-dose
regimen
- Third dose at 6-months produced increased immune response
showing 9.3-fold IgG rise and 14.8-fold functional ACE2 inhibition
increase
- Ongoing PREVENT-19 Phase 3 pediatric expansion showed robust
immune response 2-to-4-fold higher than adults against evaluated
variants, including Omicron following primary 2-dose regimen
- Developed Omicron-specific vaccine with GMP manufacturing and
lab-based assessments underway
-
- Expect delivery toward the end of the first quarter of
2022
COVID-Influenza Combination Vaccine Clinical
Development
- Ongoing Phase 1/2 trial for COVID-influenza combination
vaccine
-
- Data is expected in April
2022
- Expect to initiate Phase 2 clinical trial for COVID-influenza
combination vaccine and NanoFlu standalone in the second half of
2022
Publication Highlights
- Final analysis from PREVENT-19 Phase 3 trial in U.S. and
Mexico published in the New
England Journal of Medicine
- Final analysis from UK Phase 3 influenza co-administration
sub-study published in The Lancet Respiratory Medicine
- Final analysis of COV-Boost study led by University of
Southampton NHS published in The Lancet
Financial Results for the Three and Twelve Months Ended
December 31, 2021
Novavax revenue for the fourth quarter and full year ended 2021
were $222 million and $1.1 billion, respectively, compared to
$280 million and $476 million for the comparable periods in 2020.
The increase to royalties and other revenue in the fourth quarter
and full year 2021 was primarily the result of NVX-CoV2373 sales by
our license partners to South
Korea and Indonesia. The
increase to full year 2021 grants revenue reflects the significant
NVX-CoV2373 activities funded by both the U.S. government and the
Coalition for Epidemic Preparedness Innovations.
Research and development expenses for the fourth quarter and
full year ended 2021 were $963
million and $2.5 billion,
respectively, compared to $401
million and $747 million for
the comparable periods in 2020. The increase was primarily due to
the development and manufacturing of NVX-CoV2373, including
pre-launch inventory buildup in advance of regulatory
authorizations.
General and administrative expenses for the fourth quarter and
full year ended 2021 were $84 million
and $298 million, respectively,
compared to $61 million and
$145 million for the comparable
periods in 2020.
Net loss for the fourth quarter and full year ended 2021 were
$846 million and $1.7 billion, respectively, compared to a net
loss of $178 million and $418 million for the comparable periods in
2020.
As of December 31, 2021, Novavax
had $1.5 billion in cash, cash
equivalents, marketable securities and restricted cash, compared to
$0.8 billion as of December 31, 2020.
Financial Guidance
Novavax expects to achieve full year 2022 total revenue of
between $4 billion and $5 billion. Total revenue reflects all sources,
including product sales of Nuvaxovid by Novavax, grants revenue,
royalties and other revenue.
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) 870-4263 (Domestic) or (412) 317-0790
(International). Participants will be prompted to request to join
the Novavax, Inc. call. A replay of the conference call will be
available starting at 7:30 p.m. ET on
February 28, 2022 until 11:59 p.m. ET on March 7,
2022. To access the replay by telephone, dial (877) 344-7529
(Domestic) or (412) 317-0088 (International) and use passcode
2206365.
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 May 28, 2022.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the
genetic sequence of the first strain 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 formulated with
Novavax' patented saponin-based Matrix-M™ adjuvant 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.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid
formulation in a vial containing ten doses. The vaccination regimen
calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M
adjuvant) given intramuscularly 21 days apart. The vaccine is
stored at 2°- 8° Celsius, enabling the use of existing vaccine
supply and cold chain channels. Use of the vaccine should be in
accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization and distribution of NVX-CoV2373 worldwide.
Existing authorizations leverage Novavax' manufacturing partnership
with Serum Institute of India
(SII), the world's largest vaccine manufacturer by volume. They
will later be supplemented with data from additional manufacturing
sites throughout Novavax' global supply chain.
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™ Adjuvant
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 harnesses the power and speed of genetic
engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. NVX-CoV2373, the
company's COVID-19 vaccine, has received conditional authorization
from multiple regulatory authorities globally, including the
European Commission and the World Health Organization. The vaccine
is also under review by multiple regulatory agencies worldwide. In
addition to its COVID-19 vaccine, Novavax is also currently
evaluating a COVID-seasonal influenza combination vaccine in a
Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu,
its quadrivalent influenza investigational vaccine candidate. These
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, LinkedIn, Instagram and
Facebook.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its
operating plans and prospects, its partnerships, financial
guidance, the timing of clinical trial results, the ongoing
development of NVX-CoV2373, including Novavax' plans to initiate a
pediatric study in Q2 2022, the timing for data for the ongoing
Phase 1/2 trial for a COVID-influenza combination vaccine candidate
and plans to initiate a Phase 2 clinical trial for a
COVID-Influenza combination vaccine and NanoFlu standalone, the
scope, timing and outcome of future regulatory filings and actions,
including Novavax' plans to supplement global regulatory filings in
the first quarter of 2022 and to supplement existing authorizations
with data from additional manufacturing sites, the potential impact
of Novavax and NVX-CoV2373 in addressing vaccine access,
controlling the pandemic and protecting populations, including the
potential reach of NVX-CoV2373, the efficacy, safety and
intended utilization of NVX-CoV2373, and expected delivery of
NVX-CoV2373, including a Omicron-specific vaccine, are
forward-looking statements. Novavax cautions that these
forward-looking statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. These risks and
uncertainties include, without limitation, challenges satisfying,
alone or together with partners, various safety, efficacy, and
product characterization requirements, including those related to
process qualification and assay validation, necessary to satisfy
applicable regulatory authorities; unanticipated challenges or
delays in conducting clinical trials; difficulty obtaining scarce
raw materials and supplies; resource constraints, including human
capital and manufacturing capacity, on the ability of Novavax to
pursue planned regulatory pathways; challenges meeting contractual
requirements under agreements with multiple commercial,
governmental, and other entities; and those other risk factors
identified in the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections
of Novavax' Annual Report on Form 10-K for the year ended
December 31, 2020 and subsequent
Quarterly Reports on Form 10-Q, 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 www.sec.gov and www.novavax.com, 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,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Grants
|
94,994
|
|
259,260
|
|
948,709
|
|
453,210
|
Royalties and other
|
127,206
|
|
20,399
|
|
197,581
|
|
22,388
|
Total
revenue
|
222,200
|
|
279,659
|
|
1,146,290
|
|
475,598
|
Expenses:
|
|
|
|
|
|
|
|
Research
and development
|
962,957
|
|
401,199
|
|
2,534,508
|
|
747,027
|
General
and administrative
|
84,214
|
|
61,313
|
|
298,358
|
|
145,290
|
Total
expenses
|
1,047,171
|
|
462,512
|
|
2,832,866
|
|
892,317
|
Loss from
operations
|
(824,971)
|
|
(182,853)
|
|
(1,686,576)
|
|
(416,719)
|
Interest income
(expense), net
|
(4,835)
|
|
(3,737)
|
|
(19,763)
|
|
(14,131)
|
Other income
(expense)
|
131
|
|
9,026
|
|
(8,197)
|
|
12,591
|
Net loss before
income tax expense
|
(829,675)
|
|
(177,564)
|
|
(1,714,536)
|
|
(418,259)
|
Income
tax expense
|
16,609
|
|
--
|
|
29,215
|
|
--
|
Net loss
|
$
(846,284)
|
|
$
(177,564)
|
|
$
(1,743,751)
|
|
$
(418,259)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(11.18)
|
|
$
(2.70)
|
|
$
(23.44)
|
|
$
(7.27)
|
Basic and diluted
weighted average
|
|
|
|
|
|
|
|
number
of common shares outstanding
|
75,670
|
|
65,725
|
|
74,400
|
|
57,554
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA
(in
thousands)
|
|
|
December
31, 2021
|
|
December 31,
2020
|
|
|
|
|
Cash and cash
equivalents
|
$
1,515,116
|
|
$
553,398
|
Marketable
securities
|
--
|
|
157,649
|
Total restricted
cash
|
13,143
|
|
95,340
|
Total current
assets
|
2,155,119
|
|
1,248,203
|
Working
capital
|
(235,200)
|
|
668,531
|
Total assets
|
2,576,753
|
|
1,582,479
|
Convertible notes
payable
|
323,458
|
|
322,035
|
Total stockholders'
equity (deficit)
|
(351,673)
|
|
627,209
|
|
|
|
|
|
|
Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com
Media
Alison Chartan | 240-720-7804
Laura Keenan Lindsey |
202-709-7521
media@novavax.com
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SOURCE Novavax, Inc.