Moderna (MRNA) R&D Day 2024 summary

Strategic priorities and future plans

• Targeting ten product approvals by 2027, focusing on respiratory, latent, oncology, and rare diseases, with a shift from broad pipeline building to focused commercial expansion.

• Emphasizing commercial execution, cost efficiency, and financial discipline, including a $1.1B annual R&D reduction by 2027.

• Prioritizing launches of respiratory vaccines, with diversification into non-respiratory products and increased R&D in oncology and rare diseases from 2026 onward.

• Slowing advancement of new late-stage programs until current launches are executed, with portfolio prioritization and discontinuation of five programs.

• Leveraging AI and technology to drive efficiency and support product launches.

Pipeline and product development highlights

• Five respiratory vaccines have positive Phase 3 results; next-gen COVID (mRNA-1283), flu (mRNA-1010), and COVID/flu combo (mRNA-1083) expected to be submitted for approval in 2024.

• RSV: mRESVIA approved for 60+, with label expansion to 18–59 high-risk planned; sBLA submission in 2024.

• Latent/other: CMV and norovirus vaccines in pivotal trials, with CMV targeting congenital infection prevention and norovirus advancing to Phase 3.

• Rare diseases: Propionic acidemia and MMA programs show dramatic reductions in metabolic decompensation events and are progressing toward pivotal data in 2024.

• Oncology: INT (mRNA-4157/V940) in combination with pembrolizumab shows significant benefit in melanoma, with multiple Phase 3 trials underway and potential full approval by 2027.

Financial guidance and capital allocation

• 2025 revenue expected at $2.5–3.5B, with 2024 sales guidance at $3–3.5B; gross profit of $1.6–2B and SG&A at $1.0–1.2B.

• R&D investment to decrease from $4.8B in 2024 to $3.6–3.8B by 2027, with cumulative four-year R&D spend cut from $20B to $16B.

• Break-even on a cash cost basis now expected in 2028 at $6B revenue, later than prior 2026 guidance.

• Revenue growth projected at 25%+ per year post-2025, with meaningful new product revenue expected a year after launch.

• Sufficient capital on hand ($11B at Q2 2024) to fund the plan without equity raise; debt may be considered post-break-even.