- Achieved revenues in fourth quarter 2022 of $357 million and full year 2022 of $2.0 billion
- Appointed John C. Jacobs as
President and Chief Executive Officer
- Updated U.S. government agreement to include up to 1.5
million additional doses of Novavax's COVID-19 vaccine for
delivery in 2023
- Expanded Nuvaxovid™ label in adult booster and adolescent
primary series
- Initiated Phase 2 trial of COVID-19-Influenza Combination
and stand-alone influenza vaccine candidates
- Company to host conference call today at 4:30 p.m. ET
GAITHERSBURG, Md., Feb. 28,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its novel
Matrix-M™ adjuvant, today announced its financial results and
operational highlights for the fourth quarter and twelve months
ended December 31, 2022.
"I am excited to be joining Novavax at this important time in
the company's history," said John C.
Jacobs, President and Chief Executive Officer, Novavax.
"Much has been achieved over the past three years, and based on the
foundation that has been laid to date, I believe that Novavax has
significant potential for a bright future."
"Over the past few weeks, the management team and I have
identified three near-term priorities that we believe are essential
to our success this year and beyond: 1) to deliver a competitive
product for the upcoming 2023 fall vaccination season; 2) to reduce
our rate of spend, manage our cash flow, and evolve our scale and
structure; and 3) to leverage our technology platform, our
capabilities and our portfolio of assets to drive additional value
beyond Nuvaxovid alone. We believe that if we succeed in executing
against these priorities, we will position the company well for
long-term success."
Fourth Quarter 2022 and Recent Highlights
COVID-19 Vaccine Orders and Plans for the 2023 Fall
Vaccination Season
- Delivered over 100 million doses of Nuvaxovid, Novavax's
COVID-19 vaccine, globally to date
- Modified agreement with the U.S. government for up to 1.5
million additional doses of Novavax's COVID-19 vaccine for delivery
in 2023
-
- Agreement maintains the U.S. public's access to Novavax's
COVID-19 vaccine and supports the development of smaller dose
vials, strain selection in line with U.S. Food and Drug
Administration (FDA) recommendations and a smooth transition to the
commercial market
- Reaffirmed intent to deliver an updated mono- or bivalent
strain vaccine for the 2023 fall vaccination season, consistent
with public health recommendations
- Secured European Medicines Agency (EMA) and FDA approval of
Nuvaxovid five-dose vial variation and EMA approval of the
Company's Czech Republic facility
to manufacture antigen and supply Nuvaxovid to the E.U.
COVID-19 Vaccine Clinical Development Program and Expanded
Authorizations
- Presented data to the U.S. FDA Vaccine and Related Biological
Products Advisory Committee demonstrating that when used as a
booster, Novavax's COVID-19 vaccine induces broad functional immune
responses, including for contemporary variants
- Announced topline results from Phase 3 COVID-19 Omicron BA.1
vaccine candidate, achieving the primary strain-change
endpoint
-
- Part 2 to evaluate our prototype vaccine compared to an Omicron
BA.5 vaccine, as well as a bivalent containing prototype and
Omicron BA.5 vaccine
- Expanded Nuvaxovid label in adult booster and adolescent
primary series to enable broader uptake in the long-term commercial
market
COVID-19-Influenza Combination (CIC) Vaccine Candidate
Clinical Development
- Initiated Phase 2 dose-confirming trial to evaluate safety and
immunogenicity of different formulations of CIC and influenza
stand-alone vaccine candidates in adults aged 50 to 80 years, with
topline results expected by mid-year 2023
- CIC Phase 2 trial includes additional study arms exploring
alternate influenza stand-alone formulations
Corporate Highlights
- Appointed John C. Jacobs,
President and Chief Executive Officer and a member of the Board of
Directors, following the retirement of Stanley C. Erck, who served as President and
Chief Executive Officer for 12 years
- Appointed Elaine O'Hara, Chief
Strategy Officer, joining the organization to focus on business and
corporate development, portfolio strategy and alliance
management
- Reorganized executive leadership team to better align internal
resources and operate more efficiently; key changes include:
-
- Filip Dubovsky, Executive Vice
President, assumes the role of President, Research &
Development (R&D) following the retirement of Gregory M. Glenn, MD. Dr. Glenn will move into a
consulting role as a strategic R&D advisor
- Silvia Taylor, Executive Vice
President, promoted to Chief Corporate Affairs and Advocacy Officer
with expanded responsibilities for government affairs, policy and
advocacy, in addition to her communications role
- Troy Morgan, Chief Compliance
Officer, remains in role and now reports directly to John C. Jacobs to elevate the company's focus on
compliance
- Jim Kelly, Chief Financial
Officer, assumes responsibility for investor relations
- Strengthened Board of Directors with appointment of
Rick Rodgers, adding extensive
biopharmaceutical experience and financial leadership
- Raised $250 million in concurrent
convertible senior notes and common stock offerings
Fourth Quarter and Full Year 2022 Financial Results
- Total revenue for the fourth quarter 2022 was
$357 million and reflects 61% growth
compared to $222 million in the same
period in 2021. Total revenue for the full year 2022 was
$1.9 billion and reflects 73% growth
compared to $1.1 billion in the same
period in 2021. The growth in each period is the result of
Nuvaxovid product sales that offset a decline in Grants, Royalties
and Other Revenue and reflects the transition of Novavax to a
commercial stage company.
- Cost of sales for the fourth quarter and full year 2022
were $182 million and $903 million, respectively. These periods
included $99 million and $604 million, respectively, related to excess,
obsolete, or expired inventory and losses on firm purchase
commitments under our third-party supply agreements.
- Research and development expenses for the fourth quarter
of 2022 were $258 million as compared
to $963 million in the same period in
2021. Research and development expenses for the full year 2022 were
$1.2 billion compared to $2.5 billion in the same period in 2021. The
decrease in both periods was primarily due to a decrease in
development activities relating to coronavirus vaccines and an
increased amount of manufacturing network costs capitalized to
inventory that previously were expensed to research and
development.
- Selling, general and administrative expenses for the
fourth quarter of 2022 were $162
million compared to $84
million for the same period in 2021. Selling, general and
administrative expenses for the full year 2022 were $489 million compared to $298 million for the same period in 2021.
Expenses in both periods increased due to the commencement of
commercial sales operations in support of Novavax's COVID-19
vaccine program.
- Net loss for the fourth quarter 2022 was $182 million as compared to a net loss of
$846 million in the same period in
2021. Net loss for the full year 2022 was $658 million compared to a net loss of
$1.7 billion in the same period in
2021.
- Cash, cash equivalents, and restricted cash were
$1.3 billion as of December 31, 2022, compared to $1.5 billion as of December 31, 2021. In December 2022, Novavax raised $250 million gross proceeds in concurrent equity
and convertible securities offerings. In January 2023, Novavax funded the maturity of its
$325 million convertible notes.
Financial Framework
In 2023, Novavax intends to focus the organization to align our
investments and activities with our top priority of delivering an
updated Covid-19 vaccine consistent with public health
recommendations for strain composition for the 2023 fall
vaccination season. To maximize our opportunities and mitigate the
significant risks and uncertainties of the COVID-19 market, our
goal is to reduce spend, extend our cash runway and operate
efficiently to best position the company to deliver long-term
growth.
While our current cash flow forecast for the one-year going
concern look forward period estimates that we have sufficient
capital available to fund operations, this forecast is subject to
significant uncertainty, including as it relates to 2023 revenue,
funding from the U.S. government, and pending arbitration. Given
these uncertainties, substantial doubt exists regarding our ability
to continue as a going concern through one year from the date that
these financial statements are issued.
The accompanying condensed consolidated financial statements
have been prepared assuming Novavax will continue as a going
concern. A more detailed discussion of Novavax's liquidity position
and risk related thereto will be set forth in Novavax's Annual
Report on Form 10-K that will be filed with the SEC.
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
February 28, 2023 until 11:59 p.m. ET on March 7,
2023. To access the replay by telephone, dial (877) 344-7529
(Domestic) or (412) 317-0088 (International) and use passcode
1137418.
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, 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 Nuvaxovid™ (NVX-CoV2373)
Novavax's COVID-19 vaccine is a protein-based vaccine made by
creating copies of the surface spike protein of SARS-CoV-2 that
causes COVID-19. With Novavax's unique recombinant nanoparticle
technology, the non-infectious spike protein serves as the antigen
that primes the immune system to recognize the virus, while
Novavax's Matrix-M™ adjuvant enhances and broadens the immune
response. The vaccine is packaged as a ready-to-use liquid
formulation and is stored at 2° to 8°C, enabling the use of
existing vaccine supply and cold chain channels.
About Matrix-M™ Adjuvant
When added to vaccines, Novavax's patented saponin-based
Matrix-M adjuvant enhances the immune system response, making it
broader, and more durable. The Matrix-M adjuvant stimulates the
entry of antigen-presenting cells at the injection site and
enhances antigen presentation in local lymph nodes.
About the COVID-19-Influenza Combination (CIC) Vaccine
Candidate Phase 2 Trial
The COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase
2 Trial is a dose-confirming, randomized, observer-blinded trial
evaluating the safety and effectiveness (immunogenicity) of
different formulations of the CIC and influenza vaccine candidates
in adults aged 50 through 80. The trial will assess a CIC vaccine
comprised of Novavax's recombinant protein-based COVID-19 vaccine,
quadrivalent influenza vaccine candidate, and patented
saponin-based Matrix-M adjuvant. Primary and secondary objectives
of the study are to assess the safety, tolerability, and immune
responses to various formulations of the CIC and influenza vaccine
candidates. The Phase 2 dose-confirmation trial will be conducted
in two parts. The first part seeks to enroll a total of
approximately 1,500 participants in Australia and New
Zealand. Initial results are expected mid-year 2023. These
data will inform the phase 3 trials for both influenza stand-alone
and COVID-19-influenza combination vaccine candidates.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by
discovering, developing and commercializing innovative vaccines to
protect against serious infectious diseases. Novavax, a global
company based in Gaithersburg,
Md., U.S., offers a differentiated vaccine platform that
combines a recombinant protein approach, innovative nanoparticle
technology and Novavax's patented Matrix-M adjuvant to enhance the
immune response. Focused on the world's most urgent health
challenges, Novavax is currently evaluating vaccines for COVID-19,
influenza, and COVID-19 and influenza combined. Please visit
novavax.com and LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its near
term priorities including delivering an updated vaccine for the
2023 fall vaccination season, streamlining its investment and
organizational structure and building value for Novavax from its
technology platform and Matrix-M adjuvant, its operating plans,
objectives and prospects, including Novavax's ability to continue
as a going concern within one year after the issuance date of the
financial statements for the year ended December 31, 2022, its anticipated strategic
plan, its future financial or business performance, conditions or
strategies, its partnerships, the timing of clinical trial results,
the ongoing development of NVX-CoV2373, and a bivalent or
monovalent Omicron-based / original strain based vaccine, the CIC
investigational vaccine candidate, a quadrivalent influenza
investigational vaccine candidate, the scope, timing and outcome of
future and pending regulatory filings and actions and additional
worldwide authorizations of NVX-CoV2373 for use in adults and
adolescents and as a booster, 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; 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; unanticipated challenges or delays in
conducting clinical trials; challenges meeting contractual
requirements under agreements with multiple commercial,
governmental, and other entities; manufacturing delays or
challenges, including as a result of the timing of the anticipated
regulatory requirements for the fall 2023 vaccination season; the
loss of future funding from the U.S. government; the potential for
an unfavorable outcome in disputes, including the pending
arbitration with Gavi; 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's 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
|
|
Twelve Months
Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
287,787
|
|
--
|
|
1,554,961
|
|
--
|
|
Grants
|
69,573
|
|
94,994
|
|
382,921
|
|
948,709
|
|
Royalties
and other
|
39
|
|
127,206
|
|
43,990
|
|
197,581
|
|
Total
revenue
|
357,399
|
|
222,200
|
|
1,981,872
|
|
1,146,290
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
181,765
|
|
--
|
|
902,639
|
|
--
|
|
Research
and development
|
257,850
|
|
962,957
|
|
1,235,278
|
|
2,534,508
|
|
Selling,
general and administrative
|
161,663
|
|
84,214
|
|
488,691
|
|
298,358
|
|
Total
expenses
|
601,278
|
|
1,047,171
|
|
2,626,608
|
|
2,832,866
|
|
Income (loss) from
operations
|
(243,879)
|
|
(824,971)
|
|
(644,736)
|
|
(1,686,576)
|
|
Interest
expense
|
(4,601)
|
|
(5,138)
|
|
(19,880)
|
|
(21,127)
|
|
Other income
(expense)
|
63,971
|
|
434
|
|
10,969
|
|
(6,833)
|
|
Income (loss) before
income tax expense
|
(184,509)
|
|
(829,675)
|
|
(653,647)
|
|
(1,714,536)
|
|
Income tax
expense (benefit)
|
(2,260)
|
|
16,609
|
|
4,292
|
|
29,215
|
|
Net income
(loss)
|
$
(182,249)
|
|
$ (846,284)
|
|
$
(657,939)
|
|
$
(1,743,751)
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss)
per share
|
$
(2.28)
|
|
$
(11.18)
|
|
$
(8.42)
|
|
$
(23.44)
|
|
Basic weighted
average
|
|
|
|
|
|
|
|
|
Number of
common shares outstanding
|
79,822
|
|
75,670
|
|
78,183
|
|
74,400
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA
|
(in
thousands)
|
|
|
December
31,
2022
|
|
December
31,
2021
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
1,336,883
|
|
$
1,515,116
|
|
Total restricted
cash
|
11,962
|
|
13,143
|
|
Total current
assets
|
1,703,391
|
|
2,155,119
|
|
Working
capital
|
(756,553)
|
|
(235,200)
|
|
Total assets
|
2,258,679
|
|
2,576,753
|
|
Convertible notes
payable*
|
491,347
|
|
323,458
|
|
Total stockholders'
equity (deficit)
|
(634,078)
|
|
(351,673)
|
|
|
|
|
|
|
|
*Included in current
and noncurrent liabilities as of December 31, 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.