- Achieved total revenue for the third quarter of $735 million
- Delivered over 94 million doses of NVX-CoV2373 globally to
date
- Authorized as a booster for adults in the U.S., E.U., and
additional markets
- Authorized as a primary series for adolescents aged 12 – 17
years in U.S., EU, Japan,
and additional markets
- Announced data about our prototype's broad immune response
against circulating variants when used as a booster
- Initiated NVX-CoV2373 Phase 2b/3 study in children 6 months through 11 years
of age
- Refining full year 2022 total revenue guidance to
approximately $2.0 billion
- Company to host conference call today at 4:30 p.m. ET
GAITHERSBURG, Md., Nov. 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 third quarter
ended September 30, 2022.
"Our progress in the third quarter continued as we successfully
expanded our COVID-19 vaccine's label, achieved policy
recommendations globally and expanded our body of clinical evidence
supporting the differentiated benefit of our vaccine technology,"
said Stanley C. Erck, President and
Chief Executive Officer, Novavax. "New data that we announced today
reaffirms the broad immune responses of NVX-CoV2373 against
circulating variants. Additionally, based on our most recent Phase
1/2 trial results for our COVID-19-Influenza Combination (CIC)
vaccine candidate, we look forward to initiating our Phase 2
clinical trial by the end of this year."
Third Quarter 2022 and Recent Highlights
Expanded COVID-19 Vaccine in Adult Population Aged 18 and
Older
- Nuvaxovid™ booster authorized for emergency use in the U.S.,
European Union (EU), Switzerland,
United Arab Emirates (UAE) and
New Zealand, with submissions
completed to World Health Organization (WHO), as well as in
Great Britain and South Korea
-
- Recommendations provided by U.S. Centers for Disease Control
and Prevention (CDC), E.U.'s Committee for Medicinal Products for
Human Use and Switzerland's
Federal Office of Public Health
- Nuvaxovid granted import and use permit in Israel for primary series and as a booster
- Covovax™ granted full product registration in South Africa for primary series
Expanded COVID-19 Vaccine in Adolescent Population Aged 12
Through 17
- Nuvaxovid primary series authorized for emergency use in the
U.S., EU, Japan, Great Britain, Australia, South
Korea, Taiwan, Switzerland, Thailand, UAE and New Zealand, with submissions completed to WHO
and in Singapore
-
- Recommendation provided by U.S. CDC
- Nuvaxovid granted import and use permit in Israel for primary series and as a
booster
COVID-19 Vaccine Manufacturing and Supply
- Delivered over 94 million doses of NVX-CoV2373 globally to
date
- Completed submission to add Novavax Czech Republic as an EU
manufacturing site
- Solidified manufacturing and supply network ensuring capacity
to support ongoing global demand
COVID-19 Clinical Development Program
- Announced topline results from Phase 3 Boosting Trial for
Omicron BA.1 vaccine candidate (NVX-CoV2515), meeting the primary
strain-change endpoint and reaffirming that prototype vaccine
induces broadly cross-reactive responses, suggesting utility
against current and future variants
- PREVENT-19 Phase 3 NVX-CoV2373 homologous booster data support
benefits against variants
-
- Following a single homologous booster dose, adult participants
demonstrated increased anti-spike IgG levels and increased
functional antibody levels measured by hACE2 receptor inhibition
against Omicron BA.1, BA.2 and BA.5 variants, approximating levels
observed in our Phase 3 efficacy studies
- Robust booster responses were consistent between younger (less
than 65 years of age) and older (greater than 65 years of age)
adults, and independent of whether the booster dose was
administered eight or 11 months after the primary series, offering
further evidence of broad utility and duration of response with
NVX-CoV2373
- Adolescent participants following a single booster dose
demonstrated neutralizing titers were 2.7-fold higher than those
seen with primary vaccination and a broad antibody response against
Omicron BA.1, BA.2 and BA.5 variants
- Demonstrated NVX-CoV2373 induced consistent immune responses
when boosted on top of mRNA or AD26 vaccines, and achieved primary
endpoint of Lot Consistency study for adults aged 18 through 49,
demonstrating a consistent manufacturing process
-
- When used as a heterologous boost (after either 2 or 3 doses of
mRNA OR 1 or 2 doses of AD26) NVX-CoV2373 generated antibody levels
previously found to be related to efficacy in the PREVENT-19 Phase
3 trial
- Initiated Phase 2b/3 Hummingbird
global clinical trial for NVX-CoV2373 in younger children aged six
months through 11 years, enrolling the sentinel cohort in the first
group aged six through 11 years in the U.S.
-
- Based on initial supportive safety and tolerability data
analyzed by an independent Safety and Monitoring Committee,
progressed to recruiting the full age cohort
COVID-19-Influenza Combination (CIC) Vaccine Candidate
Clinical Development
- Announced positive cellular immunity results of CIC Phase 1/2
trial following initial results announced in April, demonstrating
ability to generate immune responses, including both antibody and
polyfunctional CD4+ T-cell responses, against SARS-CoV-2 and
homologous and heterologous influenza strains
-
- Generated robust antibody responses against both prototype and
Omicron BA.1 strains of SARS-CoV-2 and influenza antigens
- Safety and tolerability profile was consistent with standalone
NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine
candidate
- Phase 2 trial expected to begin by the end of 2022
Corporate Highlights
- Strengthened corporate leadership with appointment of a new
board member and executive promotions
-
- Rick Rodgers appointed to Board
of Directors
- Silvia Taylor promoted to
Executive Vice President, Chief Communications Officer
- Henrietta Ukwu, M.D. promoted to
Executive Vice President, Chief Regulatory Officer
Financial Results for the Three Months Ended September 30, 2022
- Total revenue for the third quarter of 2022 was
$735 million, compared to
$179 million for the comparable
period in 2021. Third quarter of 2022 total revenue includes
$628 million of revenue comprised of
$626 million of product sales from
NVX-CoV2373 based on the sale of 35 million doses sold by Novavax
and $2 million of royalties,
milestone and adjuvant sales to our license partners. Grant revenue
of $106 million in the third quarter
of 2022 compared to $135 million in
the prior year resulted from a decrease in activity under our
agreements with the Coalition for Epidemic Preparedness
Innovations.
- Cost of sales for the third quarter of 2022 were
$435 million. This includes
$249 million related to excess,
obsolete, or expired inventory and losses on firm purchase
commitments under our third-party supply agreements. 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. Cost of sales valued at expected standard costs,
including expenses related to excess and obsolete inventory, would
have been approximately $444
million.
- Research and development expenses for the third quarter
of 2022 were $304 million compared to
$408 million for the comparable
period in 2021. The decrease was primarily the result of a
$98 million benefit from the
settlement of a manufacturing agreement.
- Selling, general and administrative expenses for the
third quarter of 2022 were $123
million compared to $78
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 third quarter of 2022 was $169 million compared to a net loss of
$322 million for the comparable
period in 2021.
- Cash, cash equivalents, and restricted cash were
$1.3 billion as of September 30, 2022, compared to $1.5 billion as of December 31, 2021.
Financial Guidance
Refining full year 2022 total revenue guidance, to approximately
$2.0 billion, the low end of the
previous guidance of $2.0 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
November 8, 2022 until 11:59 p.m. ET on November
15, 2022. To access the replay by telephone, dial (877)
344-7529 (Domestic) or (412) 317-0088 (International) and use
passcode 3408655.
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 February 8, 2023.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not yet been approved by the U.S.
Food and Drug Administration.
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 spike 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 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 the vaccine 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. Food and Drug
Administration, the European Commission, and the WHO. The vaccine
is currently under review by multiple regulatory agencies
worldwide, including for additional populations and indications
such as adolescents and as a booster. In addition to its COVID-19
vaccine, Novavax is also currently evaluating its CIC vaccine
candidate in a Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and an Omicron strain-based
vaccine candidate (NVX-CoV2515) as well as a bivalent format
Omicron-based / original strain-based 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 LinkedIn.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its
strategic priorities for end of 2022, its operating plans and
prospects, financial guidance, its position in the global COVID-19
market, its partnerships, the timing of clinical trials, the
ongoing development of NVX-CoV2373, NVX-CoV2515, a bivalent vaccine
candidate, a quadrivalent influenza investigational vaccine
candidate and Novavax' CIC 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, 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 evolving 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
|
|
September
30,
|
|
2022
|
|
2021
|
|
(unaudited)
|
|
|
|
|
Revenue:
|
|
|
|
Product
sales
Grants
|
$
626,091
106,273
|
|
$
--
135,007
|
Royalties and
other
|
2,213
|
|
43,837
|
Total
revenue
|
734,577
|
|
178,844
|
Expenses:
|
|
|
|
Cost of
sales
Research and
development
|
434,593
304,297
|
|
--
408,195
|
Selling,
general, and administrative
|
122,876
|
|
77,793
|
Total
expenses
|
861,766
|
|
485,988
|
Income (loss) from
operations
|
(127,189)
|
|
(307,144)
|
Other income
(expense):
|
|
|
|
Interest income
(expense)
|
(4,169)
|
|
(5,182)
|
Other income
(expense)
|
(34,783)
|
|
(4,064)
|
Income (loss) before
income tax expense
|
(166,141)
|
|
(316,390)
|
Income tax
expense
|
2,472
|
|
6,041
|
Net income
(loss)
|
$
(168,613)
|
|
$
(322,431)
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
Basic and
diluted
|
$
(2.15)
|
|
$
(4.31)
|
Weighted average number
of common shares outstanding
Basic and
diluted
|
78,274
|
|
74,745
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA (in
thousands)
|
|
|
September
30,
2022
|
|
December
31,
2021
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
1,280,581
|
|
$
1,515,116
|
|
Total restricted
cash
|
12,441
|
|
13,143
|
|
Total current
assets
|
1,759,965
|
|
2,155,119
|
|
Working
capital
|
92,004
|
|
(235,200)
|
|
Total assets
|
2,267,437
|
|
2,576,753
|
|
Convertible notes
payable*
|
324,525
|
|
323,458
|
|
Total stockholders'
deficit
|
(565,985)
|
|
(351,673)
|
|
|
|
|
|
|
|
|
* Included in current
liabilities as of September 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.