secwatch.observer — SEC 8-K summary
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Issuer:     Moderna, Inc. (MRNA)
CIK:        0001682852
Form:       8-K
Filed at:   2024-09-12T23:59:59+00:00
Accession:  0001682852-24-000049
Event type: other_material
Sentiment:  neutral
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Moderna outlines 10 product approvals by 2027; cuts R&D spend, issues 2025 revenue guidance $2.5-3.5B
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1682852/000168285224000049/0001682852-24-000049-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1682852/000168285224000049/mrna-20240912.htm
  HTML page:      https://secwatch.observer/filing/0001682852-24-000049

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer