Novavax Reports Third Quarter 2024 Financial Results and Operational Highlights
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U.S. FDA removes clinical hold on Investigational New Drug application for COVID-19-Influenza Combination and stand-alone influenza vaccine candidates -
Achieved total revenue of
$85 million in the third quarter of 2024 -
Ended the third quarter of 2024 with
$1 billion in cash and receivables -
Received authorization from
U.S. FDA andEuropean Commission for updated 2024-2025 formula COVID-19 vaccine in individuals aged 12 and older - Outlined R&D strategy based on its proven technology platform
- Updates full year 2024 financial guidance
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Company to host conference
call today at
8:30 a.m. ET
"
Third Quarter 2024 and Recent Highlights
During the third quarter,
Priority #1: Successful Execution of
- Advanced preparation for Sanofi to assume lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine for 2025-2026 vaccination season in the
U.S. ,Europe and select major markets not currently subject to Novavax Advanced Purchase Agreements (APAs) or existing partnership agreements. - On track for the
Novavax pediatric clinical trial database lock for the first cohort in the fourth quarter of 2024, achievement triggers a$50 million milestone payment.
Priority #2: Drive Incremental Value from
- In
November 2024 , theU.S. Food and Drug Administration (FDA) removed the clinical hold onNovavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.Novavax is working to initiate the Phase 3 immunogenicity clinical trial for CIC and stand-alone influenza candidates as soon as possible. - Signed a Matrix-M adjuvant related agreement with a leading pharmaceutical company to enable exploration of our technology for the potential advancement of their pipeline candidates.
- Outlined guiding principles of new Research & Development (R&D) strategy based on its proven technology platform and announced the appointment of
Ruxandra Draghia-Akli , MD, PhD as Executive Vice President and Head of R&D. - Continued to advance pandemic influenza and respiratory syncytial virus (RSV) pre-clinical programs towards IND readiness, with a focus on RSV-combination options.
Priority #3: Continue Evolution of
- On track with cost structure improvements, including an approximate 26% reduction in combined R&D and Selling, General and Administrative (SG&A) expenses in the third quarter of 2024 compared to the same period for 2023.
- Targeting full year combined R&D and SG&A expenses of approximately
$500 million for full year 2025 and approximately$350 million for full year 2026. A portion of these expenses are expected to be reimbursed under the Sanofi Agreement. The full year 2026 target spend reflects a reduction of approximately$1.4 billion and 80% as compared to full year 2022.
Priority #4: Deliver an Updated COVID-19 Vaccine for the 2024-2025 Vaccination Season
U.S. Market:
- Received Emergency Use Authorization (EUA) from the
U.S. FDA in individuals aged 12 and older. - Entered the market with an improved product presentation and broader access -Nuvaxovid™ available in pre-filled syringe presentation in over 30,000 locations across major pharmacy retailers and regional grocers in the
U.S. -
Novavax's COVID-19 vaccine Biologics License Application (BLA) Prescription Drug User Fee Act with an action date ofApril 2025 and updated to include both JN.1 variant and pre-filled syringe presentation. Achievement of BLA approval triggers a$175 million milestone payment from Sanofi.
Global Markets:
- Received global authorizations including in the
European Union , Canada, andTaiwan .
Third Quarter 2024 Financial Results
-
Total revenue for the third quarter of 2024 was
$85 million , compared to$187 million in the same period in 2023. Product sales of$38 million for the third quarter 2024 related to primarily U.S. market commercial sales. Licensing, royalties and other revenue of$46 million in the third quarter of 2024 related to a combination of activities under the Sanofi Agreement and adjuvant sales. -
Cost of sales for the third quarter of 2024 was
$61 million , compared to$99 million in the same period in 2023. These quarters included$28 million and$74 million , respectively, related to excess, obsolete or expired inventory, losses on firm purchase commitments under third-party supply agreements and unutilized manufacturing capacity. -
R&D expenses for the third quarter of 2024 were
$87 million , compared to$106 million in the same period in 2023. The decrease was primarily due to reductions in manufacturing and clinical research-related spend. -
SG
&A expenses for the third quarter of 2024 were
$71 million , compared to$107 million for the same period in 2023. The decrease was primarily due to cost reduction activities, partially offset by commercialization expenses for Nuvaxovid. -
Net loss for the third quarter 2024 was
$121 million , compared to a net loss of$131 million in the same period in 2023. -
Cash, cash equivalents, marketable securities and restricted cash
(Cash) were
$924 million as ofSeptember 30, 2024 , compared to$584 million as ofDecember 31, 2023 .
Financial Framework
Full Year 2024 Guidance
$ in millions |
Prior
(as of |
Updated
(as of |
Total Revenue |
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Product Sales 1 |
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Licensing, Royalties and Other Revenue 2 |
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Combined R&D and SG&A |
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1. |
Full year 2024 product sales guidance reflects approximately |
2. |
Full year 2024 Licensing, royalties and other revenue guidance includes |
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
Non-GAAP Financial Measures
The Company has used a non-GAAP financial measure in this press release, which is adjusted combined R&D and SG&A expenses, net of Sanofi reimbursement costs under the Sanofi Agreement. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in
Forward-Looking Statements
Statements herein relating to the future of
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Three Months Ended |
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Nine Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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(unaudited) |
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(unaudited) |
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Revenue: |
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Product sales |
$ 38,210 |
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$ 2,231 |
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$ 140,438 |
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$ 279,937 |
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Licensing, royalties and other |
46,302 |
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19,833 |
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453,413 |
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23,046 |
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Grants |
-- |
|
164,922 |
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-- |
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389,380 |
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Total revenue |
84,512 |
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186,986 |
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593,851 |
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692,363 |
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Expenses: |
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Cost of sales |
60,619 |
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98,929 |
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166,070 |
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188,792 |
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Research and development |
87,164 |
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106,229 |
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286,789 |
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572,805 |
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Selling, general and administrative |
70,747 |
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107,460 |
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258,843 |
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313,709 |
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Total expenses |
218,530 |
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312,618 |
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711,702 |
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1,075,306 |
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Loss from operations |
(134,018) |
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(125,632) |
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(117,851) |
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(382,943) |
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Interest expense |
(4,236) |
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(2,859) |
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(12,490) |
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(10,299) |
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Other income (expense), net |
15,922 |
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(2,982) |
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27,307 |
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26,912 |
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Loss before income tax expense (benefit) |
(122,332) |
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(131,473) |
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(103,034) |
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(366,330) |
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Income tax expense (benefit) |
(1,032) |
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(697) |
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3,435 |
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343 |
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Net Loss |
$ (121,300) |
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$ (130,776) |
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$ (106,469) |
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$ (366,673) |
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Net loss per share: |
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Basic and diluted |
$ (0.76) |
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$ (1.26) |
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$ (0.71) |
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$ (3.94) |
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Weighted average number of common |
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Basic and diluted |
160,049 |
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103,429 |
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149,486 |
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93,046 |
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SELECTED CONSOLIDATED BALANCE SHEET DATA |
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2024 |
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2023 |
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(unaudited) |
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Cash and cash equivalents |
$ 573,630 |
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$ 568,505 |
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Marketable securities |
335,901 |
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-- |
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Total restricted cash |
14,957 |
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15,305 |
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Total current assets |
1,103,680 |
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1,143,888 |
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Working capital |
(77,319) |
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(491,250) |
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Total assets |
1,712,483 |
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1,797,490 |
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Convertible notes payable |
169,265 |
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168,016 |
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Total stockholders' deficit |
(526,436) |
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(716,927) |
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Contacts:
Investors
240-268-2022
ir@novavax.com
Media
202-709-5563
media@novavax.com
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