Core Insights - Moderna's shares increased by 4% following the announcement of positive preliminary immunogenicity data from a phase IV study of its updated COVID-19 vaccine, Spikevax, targeting the LP.8.1 variant [1][6] - The phase IV study demonstrated that the 2025-2026 formula of Spikevax resulted in an average increase of over 8-fold in neutralizing antibodies against the LP.8.1 variant across various age groups, with a safety profile consistent with previous studies [2][6] - The FDA approved updated COVID-19 vaccines from Moderna, Pfizer/BioNTech, and Novavax for the 2025-26 vaccination season, specifically targeting the LP.8.1 strain [4] Company Performance - Year-to-date, Moderna's shares have decreased by 40.3%, contrasting with the industry's growth of 2.8% [3] Regulatory Approvals - The FDA approved Moderna's Spikevax for individuals aged 6 months to 64 years with at least one high-risk condition, and a next-generation version called mNexspike for those aged 12 to 64 years [7] - Pfizer/BioNTech's Comirnaty was approved for at-risk individuals aged 5 years and older, showing a 4-fold increase in neutralizing antibodies against the LP.8.1 variant in a phase III study [8] - Novavax's Nuvaxovid was approved for at-risk individuals aged 12 to 64 years, being the only non-mRNA-based vaccine currently available [9]

Core Insights - The 2025-2026 formula of Spikevax has shown a greater than 8-fold increase in LP.8.1-neutralizing antibodies across various age groups [1] Company Summary - Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19 [1] - The data comes from an ongoing Phase 4 clinical trial assessing the safety, tolerability, and immunogenicity of the new formula [1] Clinical Findings - The clinical findings indicate that individuals aged 12 to 64 years with at least one underlying condition that increases the risk for severe COVID-19 outcomes, as well as all adults aged 65 and older, experienced an average of greater than 8-fold increase in neutralizing antibodies against the LP.8.1 variant [1]

Core Points - Novavax, Inc. has received FDA approval for its Nuvaxovid™ vaccine for active immunization against COVID-19 in adults aged 65 and older and individuals aged 12 to 64 with underlying conditions [1][5] - The approval has triggered a $175 million milestone payment from Sanofi, which is leading commercialization efforts for the vaccine [2][8] - Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S. and has been under Emergency Use Authorization since July 2022 [4][8] Company Developments - The approval is based on Phase 3 clinical trial data demonstrating the safety and efficacy of Nuvaxovid [3] - A new postmarketing commitment has been requested by the FDA for a Phase 4 trial in individuals aged 50 to 64 without high-risk conditions [3] - Novavax is preparing for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in partnership with Sanofi, pending FDA recommendations [4] Market Position - Market research indicates that older individuals and those with underlying conditions are likely to seek seasonal COVID-19 vaccinations, highlighting the importance of Nuvaxovid's approval [2] - Novavax is eligible for ongoing tiered royalties from future COVID-19 vaccine sales under its agreement with Sanofi [2]

Core Viewpoint - Novavax Inc. reported significant growth in first-quarter 2025 sales, driven by the termination of Advance Purchase Agreements and increased product sales, indicating a positive turnaround for the company [1][4]. Financial Performance - First-quarter 2025 sales reached $667 million, a substantial increase from $94 million in the same period last year, surpassing the consensus estimate of $343.85 million [1]. - Earnings per share for the quarter were $2.93, a recovery from a loss of $1.05, exceeding Wall Street's estimate of 71 cents [3]. - Nuvaxovid sales amounted to $608 million, up from $82 million a year ago [4]. Revenue Breakdown - Licensing, Royalties, & Other Revenue for the first quarter was $45 million, boosted by $40 million from Sanofi related to upfront payments and milestone amortization [2]. - Cost of sales decreased to $14 million from $59 million year-over-year, while R&D expenses were reduced to $89 million from $93 million [5]. - SG&A expenses fell to $48 million from $87 million, reflecting cost reduction efforts [5]. Cash Position and Guidance - As of March 31, 2025, cash and equivalents stood at $747 million, down from $938 million at the end of 2024 [6]. - For 2025, Novavax anticipates adjusted total revenue between $975 million and $1.025 billion, significantly higher than the previous range of $300 million-$350 million [7]. Strategic Focus - The company is focused on optimizing its partnership with Sanofi, advancing new and existing partnership opportunities, and developing its early-stage organic pipeline [4]. - Novavax has transitioned lead commercial responsibility of Nuvaxovid to Sanofi for select markets starting with the 2025-2026 vaccination season [6]. Regulatory Outlook - Novavax believes its Biologics License Application is approvable based on discussions with the FDA, although there has been a delay in full approval [8]. Market Reaction - Following the earnings report, NVAX stock increased by 16.10%, reaching $6.91 [8].