Press Release 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 individua ...

Core Viewpoint - Novavax, Inc. has made significant progress in its R&D strategy and financial performance, including the removal of the clinical hold on its COVID-19-Influenza Combination vaccine and the authorization for its updated COVID-19 vaccine for the 2024-2025 season [1][5][7]. Financial Performance - Total revenue for Q3 2024 was $85 million, a decrease from $187 million in Q3 2023 [9]. - Product sales amounted to $38 million, primarily from the U.S. market, while licensing, royalties, and other revenue were $46 million [9]. - The net loss for Q3 2024 was $121 million, compared to a net loss of $131 million in the same period in 2023 [9][18]. Operational Highlights - The company ended Q3 2024 with $1 billion in cash and receivables [1]. - Novavax is advancing its partnership with Sanofi for the Nuvaxovid™ COVID-19 vaccine, with a milestone payment of $50 million expected upon completion of pediatric clinical trial database lock [4]. - The FDA has removed the clinical hold on Novavax's Investigational New Drug application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates [5]. R&D Strategy - Novavax is focusing on expanding its early-stage pipeline beyond COVID-19 and influenza, utilizing its proven technology platform [2]. - The company has outlined guiding principles for its new R&D strategy and appointed Ruxandra Draghia-Akli as Executive Vice President and Head of R&D [5]. - Ongoing pre-clinical programs for pandemic influenza and respiratory syncytial virus (RSV) are being advanced towards IND readiness [5]. Cost Management - Novavax achieved a 26% reduction in combined R&D and SG&A expenses in Q3 2024 compared to the same period in 2023 [6]. - The company targets combined R&D and SG&A expenses of approximately $500 million for 2025 and $350 million for 2026, reflecting a significant reduction from previous years [6]. Market Position - The updated COVID-19 vaccine has received Emergency Use Authorization from the U.S. FDA for individuals aged 12 and older, with broader access through over 30,000 locations in the U.S. [7][9]. - Global authorizations have been received, including in the European Union, Canada, and Taiwan [9].

Key TakeawaysNovavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.Regulators stopped testing last month as one patient had a serious adverse event after taking the shot.The company said further information supported its contention that the vaccine did not cause the problem, and it will now move to resume its research as soon as possible. Novavax (NVAX) shares edged higher Monday after the drugmaker announ ...

Novavax (NVAX) is scheduled to report third-quarter 2024 earnings on Nov. 12, before the opening bell. In the last reported quarter, the company’s earnings missed estimates by 45.60%.The Zacks Consensus Estimate for sales is pegged at $57.3 million while that for earnings is pinned at a loss of 87 cents per share.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Factors Shaping NVAX’s Upcoming ResultsAlthough Novavax secured the FDA’s authorization for an updated version of its protei ...

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has 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. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that No ...

The market expects Novavax (NVAX) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on November 12, 2024, might help the stock move higher if these key numbers are ...

GAITHERSBURG, Md., Nov. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will report its third quarter 2024 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Tuesday, November 12, 2024. Details of the event and replay are as follows: Conference call details: Date: November 12, 2024 Time: 8:30 a.m. U.S. ET URL to register phone: https://emportal.ink/3Y6irHG Dia ...

Novavax (NVAX) closed the latest trading day at $10.07, indicating a -1.76% change from the previous session's end. The stock fell short of the S&P 500, which registered a gain of 0.16% for the day. At the same time, the Dow lost 0.37%, and the tech-heavy Nasdaq gained 0.78%. Shares of the vaccine maker have depreciated by 18.84% over the course of the past month, underperforming the Medical sector's loss of 4.09% and the S&P 500's gain of 1.67%. Investors will be eagerly watching for the performance of Nov ...

Knowing these will help you avoid making suboptimal investing decisions. Once you're attuned to the ebbs and flows of the healthcare sector, there are a few dead ringers that'll send a chill up your spine in anticipation of your investments losing value, and soon. In keeping with the Halloween spirit, investors should thus be on the lookout for these three spooky signs that foretell a looming downturn in their healthcare stocks. 1. You invested right after a period of windfall profits or event-driven growth ...

NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Novavax, Inc. (“Novavax” or “the Company”) (NASDAQ: NVAX). Investors who purchased Novavax securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/NVAX. Investigation Details On October 16, 2024, Novavax issued a press release “announc[ing] that the U.S. Food and Drug Adminis ...