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]