Financial Data and Key Metrics Changes - In 2025, the company reported revenues of $1.9 billion, primarily driven by sales of the COVID vaccine Spikevax and mNEXSPIKE [4][10] - Operating expenses decreased by $2.2 billion, or 30% year-over-year, reflecting significant cost management efforts [4] - The net loss for the year was $2.8 billion, an improvement from a net loss of $3.6 billion in 2024 [14] - Cash and investments at the end of 2025 totaled $8.1 billion, down from $9.5 billion at the end of 2024 [14][15] Business Line Data and Key Metrics Changes - The company had three products on the market in 2025: Spikevax, mNEXSPIKE, and mRESVIA, with mNEXSPIKE becoming the leading product in the U.S. shortly after its launch [7] - Total revenue for the fourth quarter was $700 million, with $300 million from the U.S. and $400 million from international markets [10] - U.S. revenue for the full year was $1.2 billion, while international revenue was $700 million [10] Market Data and Key Metrics Changes - In the U.S., despite a decline in overall COVID market demand, the company maintained strong market share in the retail channel, particularly with mNEXSPIKE [11] - Internationally, the company achieved revenue at the higher end of expectations, driven by operational performance and vaccination rates [11] Company Strategy and Development Direction - The company aims for up to 10% revenue growth in 2026, primarily from international markets and local manufacturing in the U.K. and Australia [15][16] - Strategic partnerships in Latin America and Asia Pacific are expected to drive growth, alongside the anticipated launch of multiple vaccines in Europe by 2027 [20][22] - The company is focused on expanding its oncology pipeline and expects significant clinical milestones in 2026 [32] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the FDA's refusal to file letter regarding the flu program, highlighting challenges in the regulatory environment [5] - The company remains optimistic about its growth potential, citing strong momentum heading into 2026 with multiple levers for revenue growth [19][33] - Management emphasized the importance of cost discipline and the adoption of AI tools to improve productivity [33] Other Important Information - The company announced a five-year strategic agreement with the government of Mexico for respiratory vaccine supply [7] - A new Chief Development Officer, Dr. David Berman, was appointed to enhance the oncology pipeline [9] Q&A Session Summary Question: Implications of flu RTF on cash flow break-even guidance and INT program timing - Management noted that the flu filing is under review in Europe, Canada, and Australia, with the U.S. refile pending a Type A meeting with the FDA [37] - The INT program for adjuvant melanoma is event-driven, with data expected this year [41] Question: Thoughts on flu and COVID combination vaccine refile - The company is awaiting feedback from the FDA on what is needed to refile the mRNA-1010 program [45] - The phase III study for mRNA-1010 showed superior efficacy compared to standard vaccines [46] Question: European COVID vaccination market and flu vaccine strain selection - The company anticipates a larger market share in Europe, with mNEXSPIKE expected to be competitive [54] - Discussions on better strain matching for flu vaccines are ongoing, with strong support from international regulators [57]

Financial Data and Key Metrics Changes - In 2025, the company reported revenues of $1.9 billion, primarily driven by sales of its COVID vaccine Spikevax and mNEXSPIKE [4][10] - Operating expenses decreased by $2.2 billion, or 30% year-over-year, reflecting significant cost management efforts [4] - The net loss for the year was $2.8 billion, an improvement from a net loss of $3.6 billion in 2024 [14] - Cash and investments at year-end totaled $8.1 billion, down from $9.5 billion at the end of 2024 [14][15] Business Line Data and Key Metrics Changes - The company had three products on the market in 2025: Spikevax, mNEXSPIKE, and mRESVIA, with mNEXSPIKE quickly becoming the leading product in the U.S. [7] - Total revenue for the fourth quarter was $700 million, with $300 million from the U.S. and $400 million from international markets [10] - The U.S. revenue for the full year was $1.2 billion, while international revenue was $700 million [10] Market Data and Key Metrics Changes - In the U.S., despite a decline in overall COVID market demand, the company maintained strong market share in the retail channel, particularly with mNEXSPIKE capturing 24% of the total U.S. retail market [11][25] - Internationally, revenue performance was driven by operational efficiency and vaccination rates meeting expectations [10] Company Strategy and Development Direction - The company aims for up to 10% revenue growth in 2026, primarily from international markets and local manufacturing in the U.K. and Australia [15][16] - Strategic partnerships in Latin America and Asia Pacific are expected to drive growth, alongside the anticipated launch of multiple vaccines in 2027 [20][22] - The company is focused on expanding its oncology pipeline and expects significant clinical milestones in 2026 [32] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the FDA's refusal to file letter regarding the flu program, highlighting regulatory uncertainty as a challenge for innovation [5] - The company remains optimistic about its growth trajectory, citing strong momentum and multiple levers for revenue growth [19][33] Other Important Information - The company has completed enrollment in several late-stage oncology studies and anticipates data readouts in 2026 [28][32] - A new Chief Development Officer has joined the company, expected to enhance the oncology pipeline [9] Q&A Session Summary Question: Implications of flu RTF on cash flow break-even guidance and INT program timing - Management is pleased with the flu filing progress in Europe and Canada, with the U.S. refile dependent on the Type A meeting with the FDA [36] - The INT program for adjuvant melanoma is event-driven, with data expected this year [40] Question: Thoughts on flu and COVID combination vaccine re-filing - The company is awaiting feedback from the FDA on what is needed for re-filing the mRNA-1010 program [43] - The phase III study for mRNA-1010 showed superior efficacy compared to standard vaccines [45] Question: European COVID vaccination market and flu vaccine strain selection - The company anticipates a larger market than the current $700 million estimate, with mNEXSPIKE expected to capture significant share [52] - Discussions on better strain matching for flu vaccines are ongoing, with strong support from international regulators [55][57] Question: Higher-than-expected cash balance explanation - The cash balance exceeded expectations due to lower cash costs and strong working capital performance [60] Question: Details on the adjuvant phase 3 melanoma study and Norovirus confidence - The adjuvant melanoma study includes interim analyses, with the first expected this year [65] - The Norovirus vaccine is targeting older adults, with a different approach than previous studies [68]

Financial Data and Key Metrics Changes - In 2025, the company reported revenues of $1.9 billion, primarily driven by sales of its COVID vaccine Spikevax and mNEXSPIKE [5][11] - Operating expenses decreased by $2.2 billion, or 30%, compared to the previous year [5] - The net loss for the year was $2.8 billion, an improvement from a net loss of $3.6 billion in 2024 [14] - The company ended the year with $8.1 billion in cash and investments, down from $9.5 billion at the end of 2024 [14][15] Business Line Data and Key Metrics Changes - The company had three products on the market in 2025: Spikevax, mNEXSPIKE, and mRESVIA, with mNEXSPIKE quickly becoming the leading product in the U.S. [7] - For the fourth quarter, total revenue was $700 million, with $300 million from the U.S. and $400 million from international markets [11] - The U.S. revenue totaled $1.2 billion for the full year, while international revenue was $700 million [11] Market Data and Key Metrics Changes - In the U.S., despite a decline in overall COVID market demand, the company maintained strong market share in the retail channel, supported by the successful launch of mNEXSPIKE [12] - Internationally, operational performance and vaccination rates exceeded expectations, contributing to revenue growth [11] Company Strategy and Development Direction - The company aims for total revenue growth of up to 10% in 2026, primarily driven by international markets and local manufacturing agreements in the U.K. and Australia [15][16] - The company plans to launch mNEXSPIKE and its combination flu-COVID vaccine in Europe by the 2027 winter season, expanding its market share [20][21] - Strategic partnerships in Latin America and Asia Pacific are expected to drive growth, alongside the anticipated approval of its flu vaccine in multiple countries [21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the FDA's refusal to file letter regarding the flu program, highlighting the challenges posed by regulatory uncertainty [6] - The company remains optimistic about its pipeline and expects continued clinical momentum, particularly in oncology and infectious disease programs [32][33] Other Important Information - The company has completed enrollment in several late-stage cancer studies and anticipates data readouts in 2026 [9][28] - A new Chief Development Officer, Dr. David Berman, will join the company, bringing extensive experience in clinical-stage immunotherapies [10] Q&A Session Summary Question: Implications of flu RTF on cash flow break-even guidance and INT program timing - Management noted that the flu filing is under review in Europe, Canada, and Australia, with the U.S. refile pending a Type A meeting with the FDA [36][37] - The INT program for adjuvant melanoma is event-driven, with data expected this year [42] Question: Thoughts on flu and COVID combination vaccine refile - The company is awaiting feedback from the FDA on what is needed to refile the mRNA-1010 program, with a comprehensive data set already submitted [45][47] - The phase III study for mRNA-1010 showed superior efficacy compared to standard vaccines [49][50] Question: European COVID vaccination market and flu vaccine strain selection - The company anticipates a larger market share in Europe, with mNEXSPIKE expected to be competitive [56][58] - Discussions on better strain matching for flu vaccines are ongoing, with strong support from international regulators [59][61]