- Received FDA EUA and CDC recommendation for NVX-CoV2373,
marking the first protein-based COVID-19 vaccine authorized in the
U.S. for adults; with immunizations underway
- Nuvaxovid™ and Covovax™ authorized for adults in 43
countries, with booster authorizations in Japan, Australia and New
Zealand as well as, adolescent authorizations in the EU,
Australia, India, Japan,
and Thailand
- Over 73 million doses delivered globally to date
- Progressing variant program with top-line clinical data for
Omicron expected near the end of the third quarter of
2022
- Adjusted revenue guidance to $2
billion to $2.3
billion
- Company to host conference call today at 4:30 p.m. ET
GAITHERSBURG, Md., Aug. 8, 2022
/PRNewswire/ -- 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 second quarter
ended June 30, 2022.
"We are pleased with our progress since the start of the second
quarter, which importantly included delivering our vaccine to the
U.S. market with immunizations underway," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "With over 23 million doses delivered since the
start of the third quarter, we are distributing our vaccine
globally and have gained positive momentum as we move into the
remainder of 2022 and into 2023. Through continued expansions to
our label for adolescents and boosting and our vaccine's
competitive product profile, we are confident it will play an
important role in the long-term COVID-19 landscape."
Second Quarter 2022 and Recent Highlights
Progressed COVID-19 Global Regulatory Strategy
- Received Emergency Use Authorization (EUA) from United States (U.S.) Food and Drug
Administration (FDA) with label expansion underway, marking first
protein-based COVID-19 vaccine available for use domestically
-
- Authorized for primary series in adults 18 and older with
unanimous recommendation received from U.S. Centers for Disease
Control and Prevention (CDC)
- Planned submission for boosting data from PREVENT-19 Phase 3
trial in August of 2022
- Nuvaxovid or Covovax authorized in 43 countries for primary
series in adults 18 and older, with additional label expansions
received and underway in several geographies
-
- Authorized for boosting in adults 18 and older in Japan, Australia and New
Zealand
-
- Nuvaxovid filings completed in the European Union (EU),
Great Britain and Switzerland
- Authorized for primary series in adolescents aged 12 through 17
in the EU, India, Australia, Japan and Thailand
-
- Nuvaxovid filings completed to the World Health Organization
(WHO), Great Britain, Canada, Switzerland, New
Zealand and Taiwan
- Expect to file for authorization of Omicron-containing vaccine
with U.S. FDA in the fourth quarter of 2022
COVID-19 Vaccine Manufacturing and
Distribution
- Delivered over 73 million doses of Nuvaxovid and Covovax
globally to date, including 23 million doses since the start of the
third quarter 2022, reflecting strong momentum for the remainder of
2022
- Secured order from U.S. government for 3.2 million initial
doses under existing agreements, with distribution underway
- Received approval from European Medicines Agency for SK
bioscience to manufacture and supply the active substance in the
Nuvaxovid COVID-19 vaccine to the EU
- Expanded partnership with SK bioscience to support
manufacturing of Omicron-containing vaccine and to manufacture
vaccine in prefilled syringes for commercial supply in 2023
COVID-19 Clinical Development Program
- Ongoing development of Omicron BA.1 specific vaccine
(NVX-CoV2515), Omicron BA.5 specific vaccine and bivalent format
with prototype vaccine (NVX-CoV2373)
-
- Announced positive preclinical boosting data for NVX-CoV2373,
NVX-CoV2515, or bivalent formulation, demonstrating strong antibody
levels
- Ongoing Phase 3 strain change trial to assess safety and
antibody responses following primary vaccination with mRNA
vaccines; initial results expected near the end of the third
quarter of 2022
- Initiated Phase 2b/3 Hummingbird
global clinical trial in younger children aged six months through
11 years with initial results expected in the first quarter of
2023
-
- Expected to enroll total 3,600 participants across nine
countries, evaluating safety, effectiveness (immunogenicity) and
efficacy of two doses of NVX-CoV2373, followed by a booster at
least six months after primary vaccination in three age
cohorts
- Advanced multiple studies evaluating homologous and
heterologous boosting in adolescents for NVX-CoV2373
-
- Completed administration of homologous third-dose booster for
select participants in PREVENT-19 Phase 3 booster study in
adolescents aged 12 through 17
- Ongoing participation in University of
Oxford's Com-COV3 Booster trial in adolescents aged 12
through 15 to evaluate heterologous boosting
COVID-19-Influenza Combination (CIC) Vaccine Candidate
Clinical Development
- Announced initial results of CIC Phase 1/2 trial demonstrating
robust immune response with both stand-alone influenza and CIC
vaccine candidates
-
- Phase 3 trial to evaluate efficacy on-track to be initiated in
2023
Financial Results for the Three Months Ended June 30, 2022
- Total revenue for the second quarter of 2022 was
$186 million, compared to
$298 million for the comparable
period in 2021. Second quarter of 2022 total revenue includes
$78 million of revenue comprised of
$55 million of product sales from
NVX-CoV2373 based on three million doses sold by Novavax and
$23 million of royalties, milestone,
and adjuvant sales to our license partners. Grant revenue of
$108 million in the second quarter of
2022 compared to $272 million in the
prior year resulted from a decrease in activity under our
agreements with the U.S. government and with the Coalition for
Epidemic Preparedness Innovations.
- Cost of sales for the second quarter of 2022 were
$271 million. This includes
$255 million related to excess,
obsolete, or expired inventory and losses on firm purchase
commitments under our third party supply agreements. The
recognition of these costs were driven by a substantial reduction
of our expected deliveries to COVAX and deferral of deliveries to
other customers. During 2021 and prior to receipt of regulatory
authorizations for NVX-CoV2373, certain manufacturing costs were
expensed to research and development that would otherwise have been
capitalized to inventory.
- Research and development expenses for the second quarter
of 2022 were $290 million compared to
$571 million for the comparable
period in 2021. The decrease was primarily the result of lower
clinical development activities for NVX-CoV2373, the capitalization
of NVX-CoV2373 manufacturing costs and a net benefit from
previously recognized embedded lease costs for manufacturing supply
agreements during the second quarter of 2022.
- Selling, general and administrative expenses for the
second quarter of 2022 were $108
million compared to $73
million for the comparable period in 2021. The increase in
the period was the result of activities in support of the
commercialization of NVX-CoV2373.
- Net loss for the second quarter of 2022 was $510 million compared to $352 million for the comparable period in
2021.
- Cash, cash equivalents, and restricted cash were
$1.4 billion as of June 30, 2022, compared to $1.5 billion as of December 31, 2021.
Financial Guidance
Revising full year 2022 total revenue guidance to $2 to $2.3 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 (833) 974-2381 (Domestic) or (412) 317-5774
(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
August 8, 2022 until 11:59 p.m. ET on August
15, 2022. To access the replay by telephone, dial (877)
344-7529 (Domestic) or (412) 317-0088 (International) and use
passcode 9237495.
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 November 8, 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. The vaccine was created using Novavax'
recombinant nanoparticle technology to generate antigen derived
from the coronavirus 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.
The 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, 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 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' Influenza Program
Novavax' influenza vaccine, previously known as NanoFlu, is a
quadrivalent recombinant hemagglutinin (HA) protein nanoparticle
influenza vaccine produced by Novavax in its SF9 insect cell
baculovirus system. The influenza vaccine uses HA amino acid
protein sequences that are the same as the recommended wild-type
circulating virus HA sequences, and contains Novavax' patented
saponin-based Matrix-M adjuvant. This investigational candidate was
evaluated during a controlled phase 3 trial conducted during the
2019-2020 influenza season.
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. The
Novavax COVID-19 vaccine, has received authorization from multiple
regulatory authorities globally, including the U.S., European
Commission and the WHO. The vaccine is currently under review by
multiple regulatory agencies worldwide, including for additional
indications and populations such as adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also currently
evaluating a COVID-seasonal influenza combination vaccine candidate
in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and
NanoFlu*, its quadrivalent influenza investigational vaccine
candidate, and is also evaluating an Omicron strain-based vaccine
(NVX-CoV2515) as well as a bivalent format Omicron-based / original
strain-based vaccine. 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 LinkedIn.
*NanoFlu identifies a
recombinant hemagglutinin (HA) protein nanoparticle influenza
vaccine candidate produced by Novavax. This investigational
candidate was evaluated during a controlled phase 3 trial conducted
during the 2019-2020 influenza season.
|
Forward-Looking Statements
Statements herein relating to the future of Novavax, its
strategic priorities for 2022, its operating plans and prospects,
financial guidance, its position in the global COVID-19 market, its
partnerships, the timing of clinical trial results, the ongoing
development of NVX-CoV2373, NVX-CoV2515, a bivalent vaccine
candidate and a COVID-seasonal influenza investigational vaccine
candidate, the scope, timing and outcome of future regulatory
filings and actions, Novavax' plans to supplement existing
authorizations with data from the additional manufacturing sites in
Novavax' global supply chain, the anticipated availability of
Omicron-containing vaccine, additional worldwide authorizations of
NVX-CoV2373 for use in adults and adolescents and as a
booster, the role that Novavax' COVID-19 vaccine will play in the
long-term COVID-19 landscape, and the efficacy, safety, intended
utilization and expected administration of NVX-CoV2373 and Novavax'
other vaccine candidates 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; the emergence of variants of the SARS-CoV-2 virus that
may negatively impact market acceptance or anticipated sales of
NVX-CoV-2373; 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, 2021 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
|
|
|
June
30,
|
|
|
2022
|
|
2021
|
|
|
(unaudited)
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product
sales
|
$
55,455
|
|
$
--
|
|
Grants
|
107,774
|
|
272,489
|
|
Royalties and
other
|
22,696
|
|
25,528
|
|
Total
revenue
|
185,925
|
|
298,017
|
|
Expenses:
|
|
|
|
|
Cost of
sales
|
271,077
|
|
--
|
|
Research and
development
|
289,648
|
|
570,685
|
|
Selling,
general, and administrative
|
108,160
|
|
73,161
|
|
Total
expenses
|
668,885
|
|
643,846
|
|
Income (loss) from
operations
|
(482,960)
|
|
(345,829)
|
|
Other income
(expense):
|
|
|
|
|
Interest income
(expense)
|
(6,234)
|
|
(5,968)
|
|
Other income
(expense)
|
(19,873)
|
|
3,028
|
|
Income (loss) before
income tax expense
|
(509,067)
|
|
(348,769)
|
|
Income tax
expense
|
1,418
|
|
3,548
|
|
Net income
(loss)
|
$
(510,485)
|
|
$
(352,317)
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
Basic
|
$
(6.53)
|
|
$
(4.75)
|
|
Weighted average number
of common shares outstanding
Basic
|
78,143
|
|
74,118
|
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA
|
|
(in
thousands)
|
|
|
|
|
June
30, 2022
|
|
December
31, 2021
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
1,375,587
|
|
$
1,515,116
|
|
Total restricted
cash
|
11,928
|
|
13,143
|
|
Total current
assets
|
2,136,002
|
|
2,155,119
|
|
Working
capital
|
(20,237)
|
|
(235,200)
|
|
Total assets
|
2,622,993
|
|
2,576,753
|
|
Convertible notes
payable*
|
324,169
|
|
323,458
|
|
Total stockholders'
equity (deficit)
|
(416,950)
|
|
(351,673)
|
|
|
* Included in current
liabilities as of June 30, 2022 and non-current liabilities as of
December 31, 2021
|
Contacts:
Investors
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.