Core Viewpoint - Moderna reported a narrower loss of $2.52 per share in Q1 2025, compared to a loss of $3.07 in the same period last year, but total revenues of $108 million fell short of expectations and declined approximately 35% year over year due to lower product sales [1][2][3] Financial Performance - Total revenues for Q1 2025 were $108 million, missing the Zacks Consensus Estimate of $127 million [1] - Product sales decreased by 49% year over year to $86 million, primarily due to lower sales of the COVID-19 vaccine Spikevax [2] - Spikevax sales were $84 million in the quarter, down from $167 million in the previous year, attributed to lower vaccination rates and the normalization of COVID into a seasonal market [3] - mResvia sales were only $2 million, significantly below the estimated $70 million, due to late approval and recommendations [4] - The company generated $22 million from grants, collaborations, licensing, and royalty revenues, with no revenues recorded in the year-ago period [6] Cost Management - Selling, general and administrative (SG&A) expenses were $212 million, down 23% year over year due to cost-cutting measures [7] - Research & development (R&D) expenses decreased by 19% to $856 million, driven by reduced clinical spending [7] Financial Guidance - Moderna reiterated its total revenue guidance for 2025, expecting revenues between $1.5 billion and $2.5 billion, with around $0.2 billion expected in the first half of the year [8] - Full-year R&D expenses are projected to be around $4.1 billion, while SG&A expenses are expected to be approximately $1.1 billion [9] - Capital expenditure is anticipated to be around $0.4 billion in 2025 [9] Pipeline Developments - Moderna submitted three regulatory filings to the FDA in Q4 2024, including for mRNA-1283 (next-generation COVID-19 vaccine) and mResvia for high-risk adults [12] - A third filing for the COVID-19 and influenza combination vaccine, mRNA-1083, is pending further data, which may delay launch plans [13] - The company has over 40 mRNA-based investigational candidates in various clinical stages, including cancer therapies [16] - Moderna is co-developing intismeran autogene with Merck, evaluating it in pivotal phase III studies for melanoma and non-small cell lung cancer [17][18] - The company plans to start a registrational study for mRNA-3705, a therapeutic candidate for methylmalonic acidemia, later this year [19]

Financial Data and Key Metrics Changes - For the full year 2024, the company recognized approximately EUR2.8 billion in revenues, a decrease from around EUR3.8 billion in 2023, primarily due to lower COVID-19 vaccine market demand [57][58] - The net loss for 2024 was EUR665 million, compared to a net profit of EUR930 million in the prior year, with a diluted loss per share of EUR2.77, down from EUR3.83 [61][62] - The cash position at the end of 2024 was EUR17.4 billion, which does not yet reflect the acquisition of Biotheus and other settlements [55][56] Business Line Data and Key Metrics Changes - Research and development expenses for 2024 reached approximately EUR2.3 billion, up from roughly EUR1.8 billion in 2023, driven by advancing priority programs [58][67] - Selling, general and administrative expenses for 2024 amounted to approximately EUR599 million, compared to EUR558 million in 2023, primarily due to the build-out of the commercial organization [59][60] Market Data and Key Metrics Changes - The company maintained a leading market share globally for its COVID-19 vaccine in collaboration with Pfizer [15] - The revenue guidance for 2025 is projected to be in the range of EUR1.7 billion to EUR2.2 billion, assuming stable vaccination rates and market share compared to 2024 [65][66] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with multiple approved products, focusing on oncology and infectious diseases [8][10] - Significant investments are planned for the clinical development of mRNA cancer immunotherapy programs and next-generation COVID-19 vaccines [11][12] - The acquisition of Biotheus is expected to enhance the company's capabilities in immunotherapy and accelerate the development of BNT327 [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the company's IP and its ability to navigate ongoing legal disputes [80] - The company anticipates 2025 to be a data-rich year with multiple updates from its oncology pipeline, particularly for BNT327 and mRNA cancer immunotherapies [72][74] Other Important Information - The company plans to share multiple clinical updates throughout 2025, including data for BNT327 and its mRNA cancer immunotherapies at upcoming oncology conferences [74] - The company is preparing for its first potential oncology product launch, BNT323, with a focus on building out its commercial organization [69][70] Q&A Session Summary Question: Overview of legal events and potential outcomes - Management indicated that predicting the timing of legal disputes is challenging and referred to the 20-F filing for detailed circumstances [79] Question: Context for FixVac data in melanoma - Management confirmed that the FixVac candidate BNT111 met its primary endpoint in a Phase 2 trial and further data will be presented later this year [82][84] Question: Partnership status for BNT327 - Management stated that the company is currently proceeding independently with BNT327 but is evaluating potential collaborations for broader applications [92][93] Question: Efficacy expectations for BNT323 in endometrial cancer - Management expects the efficacy bar for BNT323 to align with ADCs evaluated in this indication, with confidence in meeting registration requirements [112] Question: Expectations for small cell lung cancer data - Management anticipates that upcoming datasets will validate previous findings and support aggressive movement into pivotal trials [119][121]