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]
Moderna(MRNA) - 2025 Q3 - Earnings Call Transcript