Financial Data and Key Metrics Changes - Novavax reported total revenue of $667 million for Q1 2025, a significant increase from $94 million in Q1 2024, driven by $622 million in product sales [28][29] - The company reduced current liabilities by over 60% compared to year-end 2024 and improved its cost structure by reducing combined R&D and SG&A costs by 24% year-over-year [29][36] - Net income for Q1 2025 was $519 million, or $2.93 per diluted share [35] Business Line Data and Key Metrics Changes - Product sales for Q1 2025 included $603 million from the closeout of the Canada and New Zealand APA agreements, allowing Novavax to retain cash previously received [29][33] - Supply sales of $14 million in Q1 2025 were primarily related to Matrix M adjuvant sales to licensed partners [34] Market Data and Key Metrics Changes - The partnership with Takeda has improved financial terms for Novavax in Japan, enhancing its position in the third-largest healthcare market globally [8][12] - Anticipated cash flows from licensed partners include $225 million in milestones from Sanofi and a $20 million upfront payment from Takeda [31][40] Company Strategy and Development Direction - The company is focusing on three strategic priorities: optimizing the partnership with Sanofi, leveraging its technology platform to forge additional partnerships, and advancing its tech platform and early-stage pipeline [9][43] - Novavax aims for non-GAAP profitability as early as 2027, with a disciplined investment strategy in high-potential value opportunities [7][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of the BLA for the COVID vaccine and emphasized the importance of a non-mRNA protein-based vaccine option for U.S. consumers [10][11] - The company is actively seeking additional partnerships and collaborations to create multiple growth opportunities [12][13] Other Important Information - The company reiterated its full-year financial guidance for combined R&D and SG&A expenses of $475 million to $525 million, reflecting a 30% reduction compared to 2024 [30][38] - Novavax is working closely with the FDA on the parameters of the requested post-marketing commitment study related to its BLA [30][39] Q&A Session Summary Question: Nature of the post-marketing commitment FDA requested - Management has not publicly commented on the specifics of the study but is working diligently with the FDA to bring the process to a positive conclusion [46][47] Question: Target profile for KIC program and flu - The current study is designed to generate immunogenicity and safety data to inform the design of a phase three trial, not a pivotal trial [50][51] Question: Impact of the Utah Shield study on regulatory science - The Utah study is observational and not part of typical regulatory submissions; it informs consumer understanding rather than regulatory decisions [54][57] Question: Cash recognition from APA revenues - The $603 million recognized from Canada and New Zealand is non-cash, as the cash was received in prior years [71][72] Question: Safety profile of the combined vaccine - The study is designed to demonstrate immune response to both pathogens, with safety data to be supplemented from the immunogenicity data [79][80] Question: Confidence in receiving FDA approval of the BLA - Management sees a potential pathway forward for approval based on alignment on the post-marketing commitment [102][103]

Financial Performance - Total revenue for Q1 2025 reached $667 million[23], a significant increase compared to $94 million in Q1 2024[27] - Nuvaxovid sales contributed $608 million[27] to the total revenue, including $603 million related to the termination of two APAs[30] - The company reported a net income of $519 million[31] in Q1 2025, a substantial turnaround from a net loss of $148 million in Q1 2024[31] - Combined R&D and SG&A expenses decreased by 24% to $137 million in Q1 2025, compared to $180 million in Q1 2024[32] - Current liabilities were reduced by $732 million in Q1 2025[23], resulting in a current liability balance of $0.4 billion[34] Strategic Priorities and Partnerships - The company is prioritizing its partnership with Sanofi[11], expecting up to $225 million in milestones in 2025[25] - Adjusted total revenue for full year 2025 is projected to be between $975 million and $1025 million[42] - Adjusted licensing, royalties, and other revenue are expected to be between $345 million and $380 million[42], including $225 million in U S BLA & Marketing Authorizations Milestones[44] R&D and Pipeline - The company's Matrix-M adjuvant has a favorable reactogenicity profile, supported by over 60 publications[14] - Nuvaxovid recipients experienced approximately 39% fewer symptoms on average compared to mRNA vaccines[18] - The company is diversifying its R&D pipeline, including combination vaccines for COVID-19 and seasonal influenza (CIC)[21]

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].

Core Insights - Novavax has updated its collaboration and licensing agreement with Takeda, enhancing financial terms for the development, manufacturing, and commercialization of Nuvaxovid® in Japan [1][4] - The amended agreement includes an upfront payment, payments related to the 2024/2025 season, annual milestones for regulatory approvals, and royalties on net sales [1][4] - The partnership with Takeda is crucial for Novavax, reinforcing its operational capabilities in the Japanese market and validating its technology platform [2] Company Overview - Novavax, Inc. focuses on addressing significant health challenges through its expertise in vaccines and advanced technology platforms, including protein-based nanoparticles and the Matrix-M® adjuvant [2] - The company's growth strategy emphasizes forming diversified partnerships and out-licensing its technology and vaccine assets early in the development process [2] - Novavax aims to expand its pipeline, starting with infectious diseases and potentially branching into other areas [2] Market Context - Nuvaxovid®, a protein-based, non-mRNA COVID-19 vaccine, will remain available in Japan, which is recognized as the world's third-largest pharmaceutical market [4]

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]

美国食品药品管理局（FDA）：要求诺瓦瓦克斯针对被推迟的新冠疫苗接种完成新的临床试验。 ...