Novavax Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights
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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
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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
"2023 was a transition year for
Fourth Quarter 2023 and Recent Highlights
During the fourth quarter,
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 ofU.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
- Potential APA deliveries for 2024 through 2026 of over
$1 billion consisting primarily of deliveries toAustralia ,New Zealand ,Canada ,Israel andEurope - For 2024, made strategic decision to prioritize and focus commercial effort in
Europe on select key countries includingItaly ,Spain ,France and theU.K. - Spring 2024 U.K. private market launch expected for
Novavax's COVID-19 vaccine as enabled by the recent Green Book addition by theU.K. Health Security Agency
Priority #2: Reduce Rate of Spend, Manage Cash Flow and Evolve Scale and Structure
- 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 inJanuary 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™
- 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 inThe Lancet , enabling global rollout of the vaccine in eligible United Nation countries
Fourth Quarter and Full Year 2023 Financial Results
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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 ofDecember 31, 2023 , compared to$666 million as ofSeptember 30, 2023 , and$1.3 billion as ofDecember 31, 2022 . Through sales ofNovavax common stock pursuant to at-the-market offerings during the fourth quarter of 2023,Novavax raised net proceeds of$110 million .
Financial Framework
Full Year 2024 Guidance |
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$ in millions |
Full Year 2024
(as of |
Total Revenue1,2 |
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Combined R&D and SG&A |
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First Quarter 2024 Total Revenue is expected to be approximately
Total potential contract value for APAs outstanding as of
- Total Revenue includes product sales and royalties & other revenue.
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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
A webcast of the conference call can also be accessed on the
The trade name Nuvaxovid™ has not been approved by the
About
Forward-Looking Statements
Statements herein relating to the future of
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Three Months Ended |
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Twelve Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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(unaudited) |
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Revenue: |
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Product sales |
$ 251,452 |
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$ 287,787 |
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$ 531,389 |
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$ 1,554,961 |
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Grants |
37,943 |
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69,573 |
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427,323 |
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382,921 |
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Royalties and other |
1,947 |
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39 |
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24,993 |
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43,990 |
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Total revenue |
291,342 |
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357,399 |
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983,705 |
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1,981,872 |
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Expenses: |
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Cost of sales |
154,976 |
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181,765 |
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343,768 |
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902,639 |
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Research and development |
164,697 |
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257,850 |
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737,502 |
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1,235,278 |
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Selling, general, and administrative |
155,237 |
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161,663 |
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468,946 |
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488,691 |
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Total expenses |
474,910 |
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601,278 |
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1,550,216 |
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2,626,608 |
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Loss from operations |
(183,568) |
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(243,879) |
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(566,511) |
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(644,736) |
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Interest expense |
(4,117) |
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(4,601) |
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(14,416) |
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(19,880) |
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Other income |
10,984 |
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63,971 |
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37,896 |
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10,969 |
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Loss before income taxes |
(176,701) |
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(184,509) |
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(543,031) |
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(653,647) |
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Income tax benefit (expense) |
(1,688) |
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2,260 |
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(2,031) |
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(4,292) |
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Net loss |
$ (178,389) |
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$ (182,249) |
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$ (545,062) |
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$ (657,939) |
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Net loss per share: |
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Basic and diluted |
$ (1.44) |
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$ (2.28) |
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$ (5.41) |
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$ (8.42) |
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Weighted average number of common shares outstanding: |
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Basic and diluted |
123,679 |
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79,822 |
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100,768 |
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78,183 |
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SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) |
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2023 |
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2022 |
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Cash and cash equivalents |
$ 568,505 |
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$ 1,336,883 |
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Total restricted cash |
15,305 |
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11,962 |
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Total current assets |
1,143,888 |
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1,703,391 |
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Working capital |
(491,250) |
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(756,553) |
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Total assets |
1,794,490 |
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2,258,679 |
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Convertible notes payable* |
168,016 |
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491,347 |
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Total stockholders' deficit |
(716,927) |
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(634,078) |
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*Included in non-current liabilities as of |
Contacts:
Investors
240-268-2022
ir@novavax.com
Media
240-720-7804
media@novavax.com
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