Summary of Moderna FY Conference Call (March 10, 2026) Company Overview - **Company**: Moderna (NasdaqGS:MRNA) - **Fiscal Year**: 2025 - **Key Highlights**: Strong execution across revenue and cost management, significant progress in product pipeline Financial Performance - **Revenue**: $1.9 billion for FY 2025, at the high end of guidance range [2] - **Cost Reduction**: Achieved over $2 billion in cost savings, exceeding the $1 billion target set for 2025 [3] - **Cash Balance**: Ended 2025 with a cash balance of $8.1 billion, including $600 million from a credit facility [3] Product Pipeline Developments - **COVID-19 Vaccines**: - Spikevax approved for pediatric use (ages 6 months to 5 years) [4] - Positive data from Phase 3 flu vaccine study, application filed in the U.S. and other territories [4] - **Cancer Pipeline**: - Intismeran in Phase 3 for adjuvant melanoma, fully enrolled renal cell carcinoma study [4] - **Rare Diseases**: Fully enrolled study in PA, expecting readout in 2026 [42] Revenue Growth Projections - **2026 Guidance**: Up to 10% revenue growth expected, driven by: - Continued penetration of Spikevax in the U.S. (24% market share) [5] - Strategic partnerships with the U.K., Canada, and Australia, expected to generate $1 billion in international revenue [11] - **U.S. Sales Decline**: Anticipated decline in U.S. sales from $1.2 billion to $1 billion (20% decline) [11] Combination Vaccine Opportunities - **Flu-COVID Combination**: - Positive CHMP opinion received, expected approval in Europe later in 2026, contributing to revenue in 2027 [12] - Anticipated strong demand from single-payer systems internationally due to cost-effectiveness [15] - **U.S. Market**: Ongoing discussions with the FDA regarding the combination vaccine filing [13] Oncology Market Potential - **Adjuvant Melanoma**: - Multibillion-dollar market opportunity, with a 50/50 partnership with Merck [22] - Positive Phase 2 data with a hazard ratio of 0.51, aiming for similar or better results in Phase 3 [20] - **Future Indications**: Potential synergism with Keytruda, ongoing studies in various cancer types [24] Operating Expenses and Break-even Analysis - **R&D Spending**: Anticipated decrease in cash costs to $3.5 billion-$3.7 billion by 2027, with a need for revenue in that range to break even [36] - **Growth Drivers**: Expected contributions from European market openings and new partnerships in Latin America and Asia-Pacific [37] Rare Disease Program - **Partnership with Recordati**: Expected milestone payments of $160 million and tiered royalties based on sales for the PA program [42] Conclusion - **Outlook**: Exciting year ahead with multiple product approvals and significant growth opportunities in both existing and new markets [43]