Moderna (MRNA) Morgan Stanley 24th Annual Global Healthcare Conference summary

Clinical program updates and strategy

• Positive phase III adjuvant melanoma data validates T-cell priming approach, showing significant benefit over KEYTRUDA in melanoma.

• Ongoing studies include nine clinical trials with three randomized phase III trials in lung cancer, as well as studies in renal cell carcinoma and bladder cancer.

• Future investments will be data-driven, with a focus on monotherapy opportunities and earlier-stage disease, leveraging a strong financial position.

• Subgroup analyses and data maturity will inform expansion into other tumor types, with lung, bladder, and renal cell cancers as key areas of interest.

• Safety profile supports potential for broader and earlier use, with minimal significant adverse events observed.

Readout expectations and regulatory considerations

• Upcoming data presentations are anticipated at major medical meetings, with ESMO suggested as a likely venue.

• Phase II and III studies in RCC and bladder cancer are fully enrolled, randomized against standard of care, and may support registration if results are statistically significant.

• FDA approval in melanoma could streamline regulatory pathways for other indications, leveraging common manufacturing and safety data.

• Retreatment with a new INT product is theoretically possible if tumor mutations change, and regulatory processes for antigen selection updates are being developed with agencies.

Manufacturing, scalability, and commercial outlook

• Manufacturing system is highly automated and already operating at commercial scale, supporting global clinical trials in over 40 countries.

• Current facility can scale production significantly, with only one of seven suites needed for launch and ample capacity for future demand.

• Individualized therapy manufacturing is more akin to complex biologics than cell therapy, supporting competitive margins.

• Five approved vaccines, including COVID, flu, RSV, and combination products, enable portfolio-based contracting and diversification of revenue.

• Guidance remains for up to 10% top-line growth this year, with breakeven targeted for 2028, supported by the expanding vaccine portfolio.