- Achieved revenues in Q4 2023 of $291
million and full year 2023 of $1.0
billion
- Accelerating progress toward expanding
pipeline via Phase 3 COVID-19-Influenza Combination
vaccine trial in second half 2024 and potential 2026
launch
- Rescaled global footprint with 30% total headcount reduction
as compared to Q1 2023
- Announced settlement with Gavi related to 2021 advance
purchase agreement, removing financial uncertainty and
enabling focus on shared public health mission
- Provided full year 2024 total revenue guidance of
$800 million to $1 billion
- Company to host conference call today at 8:30 a.m. ET
GAITHERSBURG, Md., Feb. 28,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced its financial results and
operational highlights for the fourth quarter and twelve months
ended December 31, 2023.
"2023 was a transition year for Novavax and we have made
tremendous progress towards strengthening the financial profile of
the Company, delivering the only protein-based non-mRNA COVID-19
vaccine option to the U.S. and globally, and focusing our
investment on the future expansion of our product portfolio," said
John C. Jacobs, President and Chief
Executive Officer, Novavax. "Moving into the next chapter of our
business journey as a more lean and agile organization, we are
laser focused on improving our commercial performance in 2024 and
2025 and diversifying our revenue opportunity with our potential
combination vaccine launch which we expect in the fall of
2026."
Fourth Quarter 2023 and Recent Highlights
During the fourth quarter, Novavax continued to execute against
its three key priorities for 2023.
Priority #1: Deliver an Updated COVID-19 Vaccine for the
2023 Fall Vaccination Season
U.S. Market: Demonstrated ability to update COVID-19
vaccine and deliver the only protein-based non-mRNA option
to market.
- Gained commercial experience in the U.S. after receiving
Emergency Use Authorization with future efforts to focus on
a recalibration of U.S. field teams to focus on the retail
segment
- Progressed efforts to position the company for a stronger
performance in 2024-2025 COVID-19 vaccination season with focus on
a single-dose product presentation for delivery at the start of the
season and planned BLA approval to enable marketing and
promotion for Nuvaxovid during season
- Progressed efforts to streamline manufacturing and to advance
strain selection at risk while advocating for more timely
identification of strains by regulatory authorities
- Continued advancement of discussions for 2024-2025 COVID-19
vaccination season with major retailers who have driven 90% of the
pharmacy business
Global Markets: Delivered on 2023 Advance Purchase
Agreement (APA) obligations in Europe, Canada, Australia, New
Zealand, Singapore and
Taiwan.
- Potential APA deliveries for 2024 through 2026 of over
$1 billion consisting primarily of
deliveries to Australia,
New Zealand, Canada, Israel and Europe
- For 2024, made strategic decision to prioritize and focus
commercial effort in Europe on
select key countries including Italy, Spain,
France and the U.K.
- Spring 2024 U.K. private market launch expected for Novavax's
COVID-19 vaccine as enabled by the recent Green Book addition by
the U.K. Health Security Agency
Priority #2: Reduce Rate of Spend, Manage Cash Flow and
Evolve Scale and Structure
Novavax has made significant progress on its commitment to
improve its financial position while maintaining the capabilities
that support long-term value creation.
- Reduced full year 2023 operating expenses by $1.1 billion, or 41%, as compared to 2022
- Exceeded the previously announced global restructuring and cost
reduction plan for 2023 by approximately $150 million for combined Research and
Development (R&D) and Selling, General, and Administrative
(SG&A) expenses
- Reduced workforce by a total of 30% compared to first quarter
of 2023
- Delivered Q4 2023 doses under the Canada APA agreement and
received $175 million contingent
payment in January 2024
- Settled arbitration with Gavi, the Vaccine Alliance
(Gavi), removing financial uncertainty and enabling focus on
shared public health mission
Priority #3: Leverage Technology Platform, Capabilities,
and Portfolio of Assets to Drive Additional Value Beyond
Nuvaxovid™
Novavax remains focused on leveraging its technology platform,
including its proprietary Matrix-M adjuvant, to drive long-term
growth and protect global public health.
- Expect to initiate a pivotal Phase 3 trial for
COVID-19-Influenza Combination (CIC) vaccine candidate in the
second half of 2024, with potential for accelerated approval and
anticipated launch in 2026
- R21/Matrix-M vaccine received prequalification by the World
Health Organization (WHO) based on Phase 3 efficacy trial results,
which were recently published in The Lancet, enabling global
rollout of the vaccine in eligible United Nation countries
Fourth Quarter and Full Year 2023 Financial Results
- Total revenue for the fourth quarter of 2023 was
$291 million, compared to
$357 million in the same period in
2022. Total revenue for the full year 2023 was $984 million, compared to $2 billion in the same period in 2022.
- Cost of sales for the fourth quarter of 2023 was
$155 million, compared to
$182 million in the same period in
2022. These quarters included $30
million and $99 million,
respectively, related to excess, obsolete or expired inventory and
losses on firm purchase commitments under third-party supply
agreements. Cost of sales for the full year 2023 were
$344 million compared to $903 million in same period of 2022. These full
year periods included $112 million
and $604 million, respectively,
related to excess, obsolete or expired inventory and losses on firm
purchase commitments under third-party supply agreements.
- R&D expenses for the fourth quarter of 2023
were $165 million, compared to
$258 million in the same period in
2022. R&D expenses for the full year 2023 were $738 million compared to $1.2 billion in the same period 2022. The
decrease in both periods was primarily due to reductions in
manufacturing and clinical research related spend.
- SG&A expenses for the fourth quarter of 2023 were
$155 million, compared to
$162 million for the same period in
2022. SG&A expenses for the full year 2023 were
$469 million, compared to
$489 for the same period in 2022. The
decrease in both periods reflected commercial investment that was
offset by reductions to spend by G&A functions compared to
prior year.
- Net loss for the fourth quarter 2023 was
$178 million, compared to a net loss
of $182 million in the same period in
2022. Net loss for the full year 2023 was $545 million, compared to a net loss of
$658 million in the same period in
2022.
- Cash, cash equivalents and restricted cash were
$584 million as of December 31, 2023, compared to $666 million as of September 30, 2023, and $1.3 billion as of December 31, 2022. Through sales of Novavax
common stock pursuant to at-the-market offerings during the fourth
quarter of 2023, Novavax raised net proceeds of $110 million.
Financial Framework
Novavax is providing Full Year 2024 Financial Guidance and
expects to achieve the following objectives:
Full Year 2024
Guidance
|
|
$ in
millions
|
Full Year
2024
(as of February 28,
2024)
|
Total
Revenue1,2
|
$800 -
$1,000
|
|
|
Combined R&D and
SG&A
|
$700 - $800
|
First Quarter 2024 Total Revenue is expected to be approximately
$100 million.
Total potential contract value for APAs outstanding as of
December 31, 2023 were over
$1 billion related to expected dose
deliveries for 2024 through 2026. This amount excludes deferred
revenue associated with the 2023 Canada amendments to forfeit
doses.
- Total Revenue includes product sales and royalties &
other revenue.
- Full year 2024 guidance reflects APA expected dose
delivery schedules of $500 million to
$600 million and non-APA related
revenue of $300 million to
$400 million from a combination of
commercial market product sales plus royalties and other revenue
from our partner-related activity, subject to updated variant
manufacturing and regulatory approvals.
Conference Call
Novavax will host its quarterly conference call today at
8:30 a.m. ET. To join the call
without operator assistance, you may register and enter your phone
number at https://emportal.ink/3SqJSJv to receive an instant
automated call back. You may also dial direct to be entered to the
call by an operator. The dial-in numbers for the conference call
are (888) 664-6383 (Domestic) or (+1) (617) 892-4906
(International). Participants will be prompted to request to join
the Novavax, Inc. call. A replay of the conference call will be
available starting at 11:30 a.m. ET
on February 28, 2024, until
11:59 p.m. ET on March 6, 2024. To access the replay by telephone,
dial (416) 764-8677 (Domestic) or (+1) (888) 390-0541
(International) and use passcode 789473#.
A webcast of the conference call can also be accessed on the
Novavax website at ir.novavax.com/events. A replay of the webcast
will be available on the Novavax website until May 28, 2024.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not been approved by the U.S. Food
and Drug Administration.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by
discovering, developing and commercializing innovative vaccines to
help 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. The Company's portfolio includes its COVID-19
vaccine and its pipeline includes a vaccine for COVID-19 and
influenza combined. In addition, Novavax's adjuvant is included in
the University of Oxford and Serum
Institute of India's R21/Matrix-M
malaria vaccine. Please visit novavax.com and LinkedIn for more
information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its
mission, its near-term priorities including delivering an updated
single-dose vial COVID-19 vaccine for the start of the 2024-2025
vaccination season, initiating a pivotal Phase 3 trial for CIC in
the second half of 2024, a possible combination vaccine launch in
2026, reducing rate of spend, managing cash flow and evolving its
scale and structure, the amount and impact of Novavax's previously
announced global restructuring and cost reduction plan and new cost
reduction plan, its operating plans, objectives and prospects, full
year 2024 financial guidance, its future financial or business
performance, conditions or strategies, its ability to attain
contract value under existing APAs 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, Novavax's ability to successfully manufacture,
distribute, or market its updated COVID-19 vaccine for the upcoming
vaccination season; challenges satisfying, alone or together with
partners, various safety, efficacy, and product characterization
requirements, including those related to process qualification,
assay validation and stability testing, necessary to satisfy
applicable regulatory authorities; challenges or delays in
conducting clinical trials; challenges or delays in obtaining
regulatory authorization for its product candidates, including its
updated COVID-19 vaccine in time for the 2024-2025 vaccination
season in the U.S. and in foreign jurisdictions to meet APA
commitments or for future COVID-19 variant strain changes;
manufacturing, distribution or export delays or challenges;
Novavax's substantial dependence on Serum Institute of India Pvt.
Ltd. and Serum Life Sciences Limited for co-formulation and filling
and PCI Pharma Services for finishing Novavax's COVID-19 vaccines
and the impact of any delays or disruptions in their operations on
the delivery of customer orders; difficulty obtaining scarce raw
materials and supplies; resource constraints, including human
capital and manufacturing capacity, and constraints on Novavax's
ability to pursue planned regulatory pathways, alone or with
partners, in multiple jurisdictions simultaneously, leading to
staggered regulatory filings, and potential regulatory actions; the
potential for an unfavorable outcome in disputes; challenges in
implementing its global restructuring and cost reduction plan;
Novavax's ability to timely deliver doses; challenges in obtaining
commercial adoption and market acceptance of its updated COVID-19
vaccine, NVX-CoV2373 or any COVID-19 variant strain-containing
formulation; challenges meeting contractual requirements under
agreements with multiple commercial, governmental, and other
entities, including requirements to deliver doses that may require
Novavax to refund portions of upfront and other payments previously
received or result in reduced future payments pursuant to such
agreements; challenges related to the seasonality of vaccinations
against COVID-19; 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, 2023 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,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
251,452
|
|
$
287,787
|
|
$
531,389
|
|
$
1,554,961
|
Grants
|
37,943
|
|
69,573
|
|
427,323
|
|
382,921
|
Royalties
and other
|
1,947
|
|
39
|
|
24,993
|
|
43,990
|
Total
revenue
|
291,342
|
|
357,399
|
|
983,705
|
|
1,981,872
|
Expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
154,976
|
|
181,765
|
|
343,768
|
|
902,639
|
Research
and development
|
164,697
|
|
257,850
|
|
737,502
|
|
1,235,278
|
Selling,
general, and administrative
|
155,237
|
|
161,663
|
|
468,946
|
|
488,691
|
Total
expenses
|
474,910
|
|
601,278
|
|
1,550,216
|
|
2,626,608
|
Loss from
operations
|
(183,568)
|
|
(243,879)
|
|
(566,511)
|
|
(644,736)
|
Interest
expense
|
(4,117)
|
|
(4,601)
|
|
(14,416)
|
|
(19,880)
|
Other income
|
10,984
|
|
63,971
|
|
37,896
|
|
10,969
|
Loss before income
taxes
|
(176,701)
|
|
(184,509)
|
|
(543,031)
|
|
(653,647)
|
Income tax
benefit (expense)
|
(1,688)
|
|
2,260
|
|
(2,031)
|
|
(4,292)
|
Net loss
|
$ (178,389)
|
|
$
(182,249)
|
|
$
(545,062)
|
|
$
(657,939)
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
(1.44)
|
|
$
(2.28)
|
|
$
(5.41)
|
|
$
(8.42)
|
Weighted average number
of common shares outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
123,679
|
|
79,822
|
|
100,768
|
|
78,183
|
|
|
|
|
|
|
|
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA
(in
thousands)
|
|
|
|
|
|
December
31,
2023
|
|
December
31,
2022
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
568,505
|
|
$
1,336,883
|
|
Total restricted
cash
|
15,305
|
|
11,962
|
|
Total current
assets
|
1,143,888
|
|
1,703,391
|
|
Working
capital
|
(491,250)
|
|
(756,553)
|
|
Total assets
|
1,794,490
|
|
2,258,679
|
|
Convertible notes
payable*
|
168,016
|
|
491,347
|
|
Total stockholders'
deficit
|
(716,927)
|
|
(634,078)
|
|
|
|
|
|
|
|
*Included in
non-current liabilities as of December 31, 2023, and current and
non-current liabilities as of December 31, 2022.
|
Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com
Media
Ali Chartan
240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.