Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (State or other jurisdiction of incorporation or organization) Delaware 22-2816046 (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 000-26 ...

Core Viewpoint - Novavax (NVAX) is expected to exceed earnings expectations in its upcoming first-quarter 2025 report, with a consensus estimate for sales at $71.84 million and earnings at 19 cents per share, following a previous earnings beat of 32% [1]. Group 1: Upcoming Earnings and Sales - The company is anticipated to report earnings on May 8, 2025, before the market opens [1]. - The Zacks Consensus Estimate for sales is $71.84 million, while earnings are estimated at 19 cents per share [1]. Group 2: COVID-19 Vaccine Developments - Sanofi has acquired exclusive global marketing rights for Novavax's protein-based COVID-19 vaccine, which means Novavax is not expected to record product sales from this vaccine [1]. - An update on the technology transfer related to the COVID-19 vaccine to Sanofi and the transfer of marketing authorizations in the U.S. and Europe is expected, with Novavax eligible for milestone payments from Sanofi upon completion [2]. Group 3: Clinical Trials and Pipeline - Novavax has initiated a phase III study for its experimental COVID-19-influenza combination (CIC) and standalone influenza vaccine candidates, comparing their immunogenicity and safety [3]. - The company is also progressing in its preclinical pipeline, which includes vaccines for RSV and H5N1 bird flu, and is exploring new opportunities in diseases like varicella-zoster virus and Clostridium difficile colitis [4]. Group 4: Earnings Surprise History - Novavax has a mixed earnings surprise history, beating estimates in two of the last four quarters and missing in the other two, with an average negative surprise of 0.48% [5]. - Year-to-date, Novavax's shares have declined by 20%, contrasting with a 3% decline in the industry [5]. Group 5: Earnings Prediction Model - The company currently has an Earnings ESP of +495.75% and a Zacks Rank of 3, indicating a good chance of delivering an earnings beat [7].

Company Performance - Novavax (NVAX) closed at $6.41, unchanged from the previous session, lagging behind the S&P 500's 1.47% gain [1] - Over the past month, Novavax shares have increased by 14.46%, while the Medical sector has decreased by 2.95% and the S&P 500 by 0.47% [1] Earnings Forecast - Novavax is expected to report an EPS of $0.19 on May 8, 2025, representing a 118.1% increase year-over-year [2] - Revenue is forecasted to be $71.84 million, indicating a 23.47% decline compared to the same quarter of the previous year [2] - For the entire year, earnings are projected at $0.63 per share and revenue at $536.24 million, reflecting changes of +151.22% and -21.39% respectively compared to the previous year [3] Analyst Estimates - Recent adjustments to analyst estimates for Novavax indicate changing business trends, with upward revisions suggesting positive sentiment towards the company's operations [4] - The Zacks Rank system, which incorporates these estimate changes, currently ranks Novavax at 3 (Hold) [6] Valuation Metrics - Novavax has a Forward P/E ratio of 10.2, which is lower than the industry average of 17.32, indicating it is trading at a discount [7] - The company has a PEG ratio of 0.24, significantly below the industry average of 1.34, suggesting favorable valuation relative to expected earnings growth [8] Industry Context - The Medical - Biomedical and Genetics industry, which includes Novavax, holds a Zacks Industry Rank of 84, placing it in the top 35% of over 250 industries [9] - Research indicates that industries in the top 50% outperform those in the bottom half by a factor of 2 to 1 [9]

Core Viewpoint - The vaccine sector is experiencing a decline in stock prices following reports of a significant policy change by the FDA, which will require all new vaccines to undergo placebo-controlled clinical trials before approval [1][2]. Group 1: Market Reaction - Major vaccine companies such as GSK, Sanofi, Merck, AstraZeneca, Pfizer, BioNTech, Moderna, and Novavax have seen stock declines ranging from over 1% to more than 3.7% [1]. - Specifically, Moderna's stock dropped over 3.7%, while BioNTech fell more than 2.5% [1]. Group 2: Regulatory Changes - The FDA plans to implement a new policy requiring all new vaccines to include a placebo group in clinical trials, marking a significant shift in the vaccine approval process [1]. - This policy mandates that new vaccines must undergo safety testing with a control group receiving an inactive substance, such as saline, for comparison [1]. Group 3: Scope of the New Policy - There is uncertainty regarding the definition of "new vaccines," but it is reported that the policy is unlikely to apply to flu vaccines, which have a long-established safety record [2]. - The HHS has not clarified whether vaccines that have already completed safety studies will be subject to re-evaluation under this new policy, focusing mainly on COVID-19 vaccines in their response [2].

Group 1 - Novavax, Inc. will report its first quarter 2025 financial results and operational highlights on May 8, 2025, at 8:30 a.m. ET [1] - The conference call can be accessed via a dedicated URL and includes both domestic and international dial-in numbers [1][5] - A replay of the conference call will be available from May 8, 2025, at 11:30 a.m. ET until May 15, 2025, with specific dial-in numbers and a passcode provided for access [2] Group 2 - Novavax focuses on addressing significant health challenges through its expertise in vaccines and advanced technology platforms, including protein-based nanoparticles and the Matrix-M® adjuvant [3] - The company's growth strategy emphasizes forming diversified partnerships through out-licensing of its technology and vaccine assets, aiming to enhance its early-stage pipeline [3]

Core Insights - Novavax, Inc. has appointed Charles Newton as an independent director to its board, bringing extensive experience in public markets and healthcare investment banking [1][2] - The company aims to leverage Mr. Newton's expertise to enhance its corporate growth strategy, focusing on strategic partnerships for its R&D assets and Matrix-M® adjuvant [2][3] Company Overview - Novavax is dedicated to addressing significant health challenges through its scientific expertise in vaccines and advanced technology platforms, including protein-based nanoparticles and the Matrix-M adjuvant [4] - The company's growth strategy emphasizes building diversified partnerships via out-licensing its technology and vaccine assets earlier in the development process, with a focus on infectious diseases and potential expansion into other areas [4]

Group 1: Novavax Overview - Novavax (NVAX) shares increased by 19.5% to close at $7.47, following a notable trading volume compared to typical sessions, despite a 17.3% loss over the past four weeks [1] - The rise in share price is linked to the FDA's request for additional data on its protein-based COVID-19 vaccine, indicating progress in the regulatory process, although it suggests a delay in full approval [2] Group 2: Financial Expectations - Novavax is expected to report quarterly earnings of $0.19 per share, reflecting a year-over-year increase of 118.1%, while revenues are projected to be $71.84 million, a decrease of 23.5% from the previous year [3] - The consensus EPS estimate for Novavax has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Group 3: Industry Context - Novavax operates within the Zacks Medical - Biomedical and Genetics industry, where another company, BioNTech SE, saw its shares rise by 9.7% to $114.83, with a 7.9% return over the past month [4] - BioNTech's consensus EPS estimate has changed by +8.5% to -$2.77, representing a significant decline of 95.1% from the previous year, and it also holds a Zacks Rank of 3 (Hold) [5]

Novavax, Inc. NAVX stock traded higher on Wednesday.In an SEC filing, Novavax said, “We believe that our Biologics License Application (BLA) is approvable based on conversations with U.S. Food and Drug Administration (FDA), as of our Prescription Drug User Fee Act date on April 1 and through today.”The company said that it received formal communication from the FDA in the form of an information request for a post-marketing commitment to generate additional clinical data.Also Read: Despite Headwinds, Biotech ...

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Company Performance - Novavax closed at $6.01, with a slight increase of +0.17% on the most recent trading day, outperforming the S&P 500's loss of 2.36% [1] - Over the past month, Novavax shares have decreased by 21.05%, which is significantly worse than the Medical sector's loss of 9.83% and the S&P 500's loss of 5.6% [1] Earnings Estimates - Analysts expect Novavax to report an EPS of $0.19, representing a substantial increase of 118.1% compared to the same quarter last year [2] - The Zacks Consensus Estimate for revenue is projected at $71.84 million, reflecting a decrease of 23.47% from the previous year [2] - For the full year, earnings are projected at $0.75 per share, indicating a growth of 160.98%, while revenue is expected to decline by 21.39% to $536.24 million [3] Analyst Projections - Recent shifts in analyst projections for Novavax should be monitored, as positive estimate revisions are generally seen as favorable for the company's business outlook [4] - Empirical research shows that estimate revisions correlate with stock price performance, which is utilized in the Zacks Rank model [5] Zacks Rank and Valuation - Novavax currently holds a Zacks Rank of 3 (Hold), with the Zacks Consensus EPS estimate having increased by 579.09% in the past month [6] - The company has a Forward P/E ratio of 7.97, which is below the industry average of 15.7 [7] - Novavax's PEG ratio stands at 0.15, significantly lower than the industry average PEG ratio of 1.25 [8] Industry Context - The Medical - Biomedical and Genetics industry, which includes Novavax, has a Zacks Industry Rank of 72, placing it in the top 30% of over 250 industries [9]