other material
confidence high
sentiment neutral
materiality 0.85
Moderna outlines 10 product approvals by 2027; cuts R&D spend, issues 2025 revenue guidance $2.5-3.5B
Moderna, Inc.
- Expects ten product approvals through 2027, including three respiratory vaccine submissions in 2024 (next-gen COVID, flu/COVID combo, RSV for high-risk adults).
- Positive Phase 3 results for RSV vaccine in high-risk adults 18-59; sBLA filing planned in 2024 using Priority Review Voucher.
- Cuts cumulative R&D spend for 2025-2028 by 20% to $16B; 2025 R&D guidance $4.2-4.5B; 2025 revenue guidance $2.5-3.5B.
- Norovirus vaccine mRNA-1403 advances to Phase 3; INT melanoma Phase 3 substantially enrolled but FDA not supportive of accelerated approval.
- Five pipeline programs discontinued; plans to break even on operating cash cost basis in 2028 with $6B revenue.