Financial Data and Key Metrics Changes - In Q3 2025, the company's revenue was $1 billion, a 45% year-over-year decline primarily due to lower COVID vaccine demand [4][10][12] - The net loss for the quarter was $200 million, compared to a net income of $13 million in Q3 2024, resulting in a loss per share of $0.51 [15][12] - Cash and investments at the end of Q3 were $6.6 billion, down from $7.5 billion at the end of Q2 2025 [16] Business Line Data and Key Metrics Changes - Revenue from U.S. markets was $800 million in Q3, with the majority from COVID vaccines, while international revenue was $200 million, with Canada accounting for half of that [10][11] - The cost of sales decreased by 60% year-over-year to $207 million, driven by lower inventory write-downs and reduced manufacturing capacity [14] - R&D expenses were $801 million, a 30% decrease from the previous year, reflecting lower clinical trial costs [14] Market Data and Key Metrics Changes - Cumulative retail vaccinations in the U.S. were 13.2 million as of October 24, 2025, down approximately 30% year-over-year [23][45] - The company's market share for COVID vaccines in the U.S. increased to 42%, with mNEXSPIKE accounting for 55% of COVID vaccination volume [23][65] Company Strategy and Development Direction - The company is focused on driving the use of its commercial products, advancing its pipeline, and executing with financial discipline [5][8] - Strategic partnerships have been established in Canada, the U.K., and Australia, with manufacturing facilities and multi-year offtake agreements [5][6] - The company aims to transition from a pandemic-focused product line to a diversified portfolio including seasonal vaccines and oncology medicines [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing cost reduction efforts, projecting a $500 million reduction in cash costs since the last investor call [9][31] - The company anticipates a cash break-even point by 2028, with a focus on revenue growth through geographic expansion and new product introductions [57][58] - Management acknowledged challenges in the COVID vaccination market but remains optimistic about the potential for mNEXSPIKE and other pipeline products [30][65] Other Important Information - The company announced the discontinuation of its CMV vaccine program after failing to meet primary efficacy endpoints [8][46] - The company is on track to reduce its GAAP operating expenses significantly, with a new target of $5.3 billion for 2025 [17][19] Q&A Session Summary Question: Expense management and strategy for 2026 - Management indicated that cost reductions are driven by efficiencies rather than deprioritization of investments, with a focus on optimizing R&D execution [35][36] Question: U.S. COVID revenue and inventory tracking - Management confirmed that U.S. sales are primarily measured by vaccinations, with a 30% decline in shots in arms year-over-year [42][45] Question: Norovirus program and case accrual - Management noted that slow case accrual was anticipated and does not reflect a change in the commercial opportunity for the norovirus vaccine [50][52] Question: Confidence in cash break-even guidance for 2028 - Management emphasized that achieving break-even will depend on both revenue growth and continued cost reductions [56][57] Question: Feedback on mNEXSPIKE and market share evolution - Management reported positive feedback on mNEXSPIKE, which has become the leading product in the COVID franchise, with expectations for continued growth [63][65]

Financial Data and Key Metrics Changes - In Q3 2025, the company's revenue was $1 billion, a 45% year-over-year decline primarily due to lower COVID vaccine demand [3][10] - The net loss for the quarter was $200 million, compared to a net income of $13 million in Q3 2024, resulting in a loss per share of $0.51 [12][13] - Cash and investments at the end of Q3 were $6.6 billion, down from $7.5 billion at the end of Q2 2025 [13] Business Line Data and Key Metrics Changes - Revenue from U.S. markets was $800 million in Q3, with the majority from COVID vaccines, while international revenue was $200 million, with approximately half from Canada [8][9] - Cost of sales decreased by 60% year-over-year to $207 million, driven by lower inventory write-downs and reduced manufacturing capacity [11] - R&D expenses were $801 million, a 30% decrease from the previous year, reflecting lower clinical trial costs [12] Market Data and Key Metrics Changes - The U.S. COVID vaccination market saw a 30% year-over-year decline in cumulative retail vaccinations, with Moderna's market share increasing to 42% [20][21] - The company expects fourth-quarter sales in the U.S. to range from $100 million to $400 million, with full-year U.S. revenue guidance adjusted to $1 billion to $1.3 billion [9][10] Company Strategy and Development Direction - The company is focused on driving the use of its commercial products, advancing its pipeline, and executing with financial discipline [4][6] - Strategic partnerships have been established in Canada, the U.K., and Australia, with local manufacturing facilities and multi-year offtake agreements [4][5] - The company aims to transition from a pandemic-focused business to a diversified portfolio in seasonal vaccines, oncology, and rare diseases [30][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in the COVID vaccine market but expressed confidence in the growth of mNEXSPIKE and the overall pipeline [29][30] - The company is committed to achieving cash break-even by 2028, with ongoing cost reductions and revenue growth strategies [30][56] Other Important Information - The company has discontinued the development of its CMV vaccine after failing to meet primary efficacy endpoints [6][24] - The company has narrowed its revenue guidance for 2025 to $1.6 billion to $2 billion, down from $1.5 billion to $2.2 billion [9][16] Q&A Session Summary Question: Can you help us understand what's being deprioritized to allow for expense management? - The company is driving efficiencies without deprioritizing investments, focusing on reducing unutilized manufacturing capacity and waste [34][35] Question: What is the learning from the CMV vaccine trial? - The pentamer neutralizing antibody response was not sufficient to improve prevention of infection, and further data will be analyzed [44][46] Question: Are you surprised by the slow case accruals in the norovirus program? - The company anticipated the need for a two-season study and remains confident in the commercial opportunity for a highly effective vaccine [50][51] Question: What gives you confidence in the cash break-even target for 2028? - The company sees opportunities for revenue growth through geographic expansion and new product introductions while continuing cost reductions [55][56] Question: How do you expect the split between mNEXSPIKE and Spikevax to evolve? - mNEXSPIKE has become the leading product in the COVID franchise, with expectations for continued growth, while Spikevax will still serve a specific pediatric market [60][61]