- Achieved revenue of $704
million and net income of $203
million highlighting the first profitable quarter as a
commercial stage company
- Reiterating full year 2022 total revenue guidance of between
$4 and $5
billion
- Continued label expansion including primary, booster and
adolescent authorizations and new shipments of
Nuvaxovid™ into European Union, Canada, South
Korea, Australia Thailand, Singapore and New
Zealand
- Submitted request for EUA to U.S. FDA for NVX-CoV2373, with
FDA Advisory Committee meeting scheduled for June 7th
- Announced positive Phase 1/2 results of COVID-19-Influenza
Combination vaccine candidate confirming feasibility of
approach
- Company to host conference call today at 4:30 p.m. ET
GAITHERSBURG, Md., May 9, 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 first quarter
ended March 31, 2022.
"Novavax has been successful in launching our protein-based
COVID-19 vaccine worldwide and executing on our plans for ongoing
label expansions for pediatrics and homologous and heterologous
boosting. Reinforced by our first profitable quarter, with
$704 million in revenue, we are
continuing our robust commercial rollout." said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "Importantly, as new variants have emerged, we
have progressed our strategy to be ready to address the dynamic
environment and continue development beyond COVID-19 with our
COVID-19-Influenza Combination vaccine candidate."
First Quarter 2022 and Recent Highlights
Expanded Worldwide Authorizations for COVID-19 Primary and
Booster Vaccination in Adult Population Aged 18+
- Received manufacturing and marketing approval with our partner
Takeda Pharmaceutical Company Limited, in Japan for Nuvaxovid for primary, heterologous
and homologous boosting indications
- Granted authorization (emergency use, provisional, interim or
conditional) for Nuvaxovid in Great
Britain, Canada,
Australia, Switzerland, Singapore and New
Zealand
- Received full regulatory approval for Nuvaxovid in South Korea with our partner SK bioscience,
becoming the first protein-based vaccine approved in South Korea
- Granted emergency use authorization (EUA) for Covovax™ with our
partner the Serum Institute of India Pvt. Ltd. (SII) in
Thailand and Bangladesh
- Submitted request for EUA to U.S. FDA and, with SII, filed for
EUA in South Africa
-
- FDA scheduled Vaccines and Related Biological Products Advisory
Committee (VRBPAC) meeting for June
7th
Progressed COVID-19 Vaccine Regulatory Pathway for
Children Aged 12-17 Years
- Granted EUA for adolescents in India with SII for Covovax
- Submitted requests for authorization for Nuvaxovid in
adolescents to the European Union, Great
Britain, Australia and
New Zealand
- Filed for approval of Nuvaxovid with SK bioscience, for
adolescents in South Korea
- Additional global submissions planned throughout the second
quarter of 2022
COVID-19-Influenza Combination (CIC) Vaccine Candidate
Clinical Development
- Announced initial results of CIC Phase 1/2 trial, combining
NVX-CoV2373 and quadrivalent influenza vaccine candidate
-
- Immune response confirmed in stand-alone influenza vaccine
candidate and CIC vaccine candidate with potential path forward for
both
- Demonstrated combined formulation has potential to reduce total
antigen amount by up to 50% overall
- Expect to begin CIC Phase 2 trial by the end of 2022
COVID-19 Vaccine Supply and Distribution
- Delivered Nuvaxovid globally to European Union, Canada, Australia, Thailand, Singapore and New
Zealand and with SK bioscience to South Korea
COVID-19 Vaccine Clinical Development
- UK Phase 3 study demonstrated ongoing durability of protection
against infection and disease in long term follow-up (median of 101
days)
-
- 82.5% efficacy in protection against all COVID-19 infection, as
measured by PCR+ or anti-N seroconversion
- 82.7% overall efficacy against disease
- 100% efficacy against severe disease
- Continued rapid development and assessment of strain change,
including Omicron-specific clinical studies with topline readout
expected in third quarter of 2022
-
- Evaluating benefit of Omicron-specific (BA.1 and BA.2) or
bivalent vaccine compared to current prototype, with first doses
expected this month
- Progressed South Africa Phase 2 study with ongoing
administration in participants to evaluate a three-dose regimen and
different dosing schedules in -immunocompromised participants,
providing flexibility to national delivery programs
-
- Topline results expected in fourth quarter of 2022
- Progressed PREVENT-19 Phase 3 study in adolescents aged 12-17
years
-
- Achieved primary effectiveness endpoint and demonstrated
comparability to adult population
- Demonstrated 80% overall clinical efficacy and 82% efficacy
against Delta variant
- Vaccine was generally well-tolerated and safety profile was
consistent with previous studies
- Initiated booster study to evaluate safety and immunogenicity
of a third dose
- Continued clinical trials in younger age groups to build on
positive pediatric data
-
- Expect to initiate PREVENT-19 Phase 3 trial in younger age
groups (5-11 years) by third quarter of 2022
- SII generated positive data from Phase 2/3 India study in children ages 2-17 years
showing robust immune responses with favorable reactogenicity
profiles
- Announced participation in Phase 1/2 heterologous booster study
sponsored by National Institute of Allergy and Infectious
Diseases
-
- Evaluating safety, reactogenicity and immunogenicity of
heterologous boosters in approximately 180 individuals aged 18
years or older
- Topline results expected later this year and full results in
2023
- Announced participation in Phase 3 study in the United Arab Emirates evaluating boost with
NVX-CoV2373 in participants who were immunized with an inactive
COVID-19 vaccine in individuals aged 18 years or older
Financial Results for the Three Months Ended March 31, 2022
- Total revenue for the first quarter of 2022 was
$704 million, compared to
$447 million for the comparable
period in 2021. First quarter of 2022 total revenue includes
$605 million of revenue comprised of
$586 million of product sales from
NVX-CoV2373 based on 31 million doses sold by Novavax and
$19 million of royalties and adjuvant
sales to our license partners. Grant revenue of $99 million in the first quarter of 2022 compared
to $447 million in the prior year
resulted from a decrease in funding under our agreements with the
U.S. government and with the Coalition for Epidemic Preparedness
Innovations.
- Cost of sales for the first quarter of 2022 were
$15 million and 3% of product sales
in the period. 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 first quarter
of 2022 were $383 million compared to
$593 million for the comparable
period in 2021. The decrease was primarily the result of lower
clinical development activities for NVX-CoV2373 and the
capitalization of NVX-CoV2373 manufacturing costs during the first
quarter of 2022.
- Selling, general and administrative expenses for the
first quarter of 2022 were $96
million compared to $63
million for the comparable period in 2021. The increase in
the period was the result of activities in support of the
commercial launch of NVX-CoV2373.
- Net income for the first quarter of 2022 was
$203 million compared to a net loss
of $223 million for the comparable
period in 2021.
- Cash, cash equivalents, and restricted cash were
$1.6 billion as of March 31, 2022, compared to $1.5 billion as of December 31, 2021. Through sales of Novavax
common stock pursuant to at-the-market (ATM) offerings during the
first quarter of 2022, Novavax raised net proceeds of $179 million.
Financial Guidance
Novavax continues to expect to achieve its full year 2022 total
revenue of between $4 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 (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
May 9, 2022 until 11:59 p.m. ET on May 16,
2022. To access the replay by telephone, dial (877) 344-7529
(Domestic) or (412) 317-0088 (International) and use passcode
9339969.
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 August 9, 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 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. 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 candidate
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.
*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
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, a COVID-19-Influenza combination
vaccine candidate, including plans to initiate a Phase 2 clinical
trial by the end of 2022, the scope, timing and outcome of future
regulatory filings and actions, including Novavax' upcoming FDA
Advisory Committee meeting and including Novavax' plans for
additional global submissions throughout the second quarter of
2022, 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
COVID-19-Influenza combination vaccine candidate, and expected
administration 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, 2021, 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
|
|
March 31,
|
|
2022
|
|
2021
|
|
(unaudited)
|
|
|
|
|
Revenue:
|
|
|
|
Product
sales
|
$
585,628
|
|
$
--
|
Grants
|
99,301
|
|
446,893
|
Royalties and
other
|
19,042
|
|
336
|
Total revenue
|
703,971
|
|
447,229
|
Expenses:
|
|
|
|
Cost of
sales
|
15,204
|
|
--
|
Research
and development
|
383,483
|
|
592,671
|
Selling,
general, and administrative
|
95,992
|
|
63,190
|
Total expenses
|
494,679
|
|
655,861
|
Income (loss) from
operations
|
209,292
|
|
(208,632)
|
Other income
(expense):
|
|
|
|
Interest
income (expense)
|
(4,876)
|
|
(4,839)
|
Other
income (expense)
|
1,654
|
|
(6,231)
|
Income (loss) before
income tax expense
|
206,070
|
|
(219,702)
|
Income tax
expense
|
2,662
|
|
3,017
|
Net income
(loss)
|
$
203,408
|
|
$
(222,719)
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
Basic
|
$
2.66
|
|
$
(3.05)
|
Diluted
|
$
2.56
|
|
$
(3.05)
|
Weighted average number
of common shares outstanding
Basic
|
76,457
|
|
73,035
|
Diluted
|
80,711
|
|
73,035
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA
(in
thousands)
|
|
|
March 31,
2022
|
|
December 31,
2021
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
1,570,954
|
|
$
1,515,116
|
|
Total restricted
cash
|
13,146
|
|
13,143
|
|
Total current
assets
|
2,347,405
|
|
2,155,119
|
|
Working
capital
|
86,400
|
|
(235,200)
|
|
Total assets
|
2,834,875
|
|
2,576,753
|
|
Convertible notes
payable*
|
323,814
|
|
323,458
|
|
Total stockholders'
equity (deficit)
|
65,324
|
|
(351,673)
|
|
|
* Included in current
liabilities as of March 31, 2022 and non-current liabilities as of
December 31, 2021
|
Contacts:
Investors
Alex Delacroix | 240-268-2022
ir@novavax.com
Media
Alison Chartan | 240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.