Novavax Reports Third Quarter 2024 Financial Results and Operational Highlights
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 and European 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
Company to host conference call today at 8:30 a.m. ET
GAITHERSBURG, Md., Nov. 12, 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 third quarter ended September 30, 2024.
"Novavax continues to focus on our corporate growth strategy of driving value from additional business development activities and organic R&D using our proven technology platform," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In addition to progress on our other value drivers, this past quarter, we made significant progress defining our R&D strategy as we look to expand beyond COVID-19 and influenza. We intend to develop our early-stage pipeline with a disciplined approach, as we focus on areas where our technology can have a positive impact on public health and generate value."
Third Quarter 2024 and Recent Highlights
During the third quarter, Novavax continued executing against its four key priorities.
Priority #1: Successful Execution of Sanofi Partnership
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 Novavax's Proven Technology Platform
In November 2024, the U.S. Food and Drug Administration (FDA) removed the clinical hold on Novavax'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 Novavax and Reduce Operating Expenses
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 of April 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, and Taiwan.
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 of September 30, 2024, compared to $584 million as of December 31, 2023.
Financial Framework
Novavax is updating its Full Year 2024 Financial Guidance and expects to achieve the following objectives.
Full Year 2024 Guidance
$ in millions
Prior
(as of Aug. 8, 2024)
Updated
(as of Nov. 12, 2024)
Total Revenue
$700 - $800
$650 - $700
Product Sales 1
$275 - $375
$175 - $225
Licensing, Royalties and Other Revenue 2
$425
$475
Combined R&D and SG&A
$700 - $750
$700 - $750
1.
Full year 2024 product sales guidance reflects approximately $100 million in APA dose deliveries in 1H 2024 and $75 million to $125 million of commercial market sales in 2H 2024.
2.
Full year 2024 Licensing, royalties and other revenue guidance includes $450 million of revenue recognition from the $500 million Sanofi agreement upfront payment and $25 million in royalty and other revenue from partner-related activities.
Conference CallNovavax 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/3Y6irHG ...
