Moderna(MRNA)2024-11-07 17:08Financial Data and Key Metrics - Revenue for Q3 2024 was 13 million [7] - Cash and investments at the end of Q3 2024 totaled 10.8 billion at the end of Q2 2024 [32] - Operating expenses were reduced by 1.4 billion charge from Q3 2023 [7] - Cost of sales declined by 77% year-over-year to 514 million in Q3 2024, driven by manufacturing productivity improvements [28] - R&D expenses decreased by 2% year-over-year to 1.1 billion in Q3 2024, excluding a priority review voucher purchase [29] - SG&A expenses decreased by 36% year-over-year to 10 million in Q3 2024, below expectations due to late approval and competitor inventory buildup [14] - The company expects to increase RSV market share in 2025 with full participation in the contracting season and potential label expansion [15] Market Performance - U.S. market contributed 140 million provision release [23] - International sales were 200 million and 600 million and 800 million [25][27] Strategy and Industry Competition - The company aims to drive COVID vaccination rates closer to flu vaccination rates, particularly in under-penetrated channels like IDNs and government programs [11][13] - Moderna is focusing on educating healthcare providers and consumers about the benefits of COVID vaccination, including reducing the risk of long COVID [12][13] - The company plans to expand its manufacturing footprint in the U.K., Canada, and Australia in 2025 to fulfill multi-year contracts [53] Management Commentary on Operating Environment and Future Outlook - The COVID market is expected to remain a sizable and durable long-term market, with Moderna well-positioned to capture growth [9] - The company is optimistic about the potential for RSV market expansion, particularly with international approvals and potential revaccination recommendations [15] - Moderna is committed to improving cost efficiencies, with a goal to reduce annual R&D expenses by 1.1 billion by 2027 [55] Other Important Information - The company expanded its executive committee, promoting internal talent and emphasizing the integration of digital technology and AI [18][19] - Moderna expects to file for approval of three products in 2024: next-gen COVID vaccine, RSV vaccine for high-risk individuals, and a combination COVID-flu vaccine [54] Q&A Session Summary Question: Rest of world revenue and CMV interim analysis [58] - Rest of world revenue in Q3 2024 was driven by orders from the U.K., Canada, Australia, and Brazil, with most of the 63 per dose, and reserve returns for the 2023-2024 season were adjusted to $400 million [70][75] - The company decided not to use a priority review voucher for the flu-COVID combo due to timing constraints, with potential approval in 2025 [71][72] Question: RSV market dynamics and COVID market share [78][107] - The RSV market has been slower than expected, with inventory buildup and delayed CDC guidelines impacting sales [81][82] - Moderna lost some market share in the U.S. retail COVID market but expects to gain a clearer picture of overall market share by the end of the season [108] Question: INT program and manufacturing [90] - The INT manufacturing facility in Massachusetts is on track for completion by year-end, with no bridging work required for FDA approval [91][92] Question: Election impact and RSV international expansion [94] - The company is confident in its ability to work with any administration to advance public health goals [96] - RSV market expansion outside the U.S. is expected to grow, but timing depends on regulatory approvals and pricing negotiations [97][98] Question: Orphan disease pipeline [102] - Pivotal trials for MMA and PA are expected to start in 2025, with potential launches in 2026 or later, depending on enrollment and trial progress [103][104] Question: Flu-COVID combo transition and COVID litigation [118] - The flu-COVID combo is not expected to transition the market in 2025 due to contracting timing, with potential impact in 2026 [119][120] - The company is prepared to defend against GSK's lawsuit, which is common during market formation around new technologies [122]