Moderna, Inc. Q3 FY2026 earnings call

• Commercial Execution: Delivered strong Q3 results with $1.3B revenue, driven by robust demand and operational execution in both US and international markets. International YTD revenue of $900M is already $200M ahead of full-year 2025 levels.
• Regulatory Milestones: Received FDA approval for mFluciva (mRNA influenza vaccine) for adults 50+, marking the fifth approved product. Secured approvals for mFluciva and mCoFlu (combination flu/COVID vaccine) in Canada. Approved strain updates for MNEXT Spike in the US, Canada, Japan, and Taiwan for the 2026-2027 season.
• Oncology Breakthrough: Presented positive Phase 3 data for Intismaran Autogen (individualized cancer therapy with Merck) in adjuvant melanoma. Demonstrated a 42% reduction in risk of recurrence or death vs. pembrolizumab alone, with a 49% reduction in the modified intent-to-treat population. First positive Phase 3 trial for an individualized cancer vaccine and first showing benefit over anti-PD-1 monotherapy in this setting.
• Financial Discipline & Capital Structure: Raised $2.6B in net proceeds from a convertible debt offering. Reduced cash costs by 10% compared to Q3 last year. Ended the quarter with $8B in cash and investments. Welcomed back Juan Andres to the Executive Committee to lead manufacturing scale-out.
• Pipeline Progress: Ebola vaccine mRNA-1469 advanced to Phase II-III per WHO recommendation. Norovirus vaccine mRNA-1403 did not meet interim success criteria; program paused for regulatory discussions. T-cell engager mRNA-2808 showed proof-of-concept in multiple myeloma.

Moderna reported total revenue of $1.3 billion for the third quarter of 2026, representing a 29% year-over-year growth. This strong commercial performance translated into a net income of $200 million (adjusted to $162 million per financial statements) and diluted EPS of $0.38. The geographic revenue mix was approximately 60% from the U.S. market and 40% from international markets. While specific product-level revenue contributions were not broken down in absolute terms within the transcript, the growth was primarily driven by increased adoption of MNEXT Spike (COVID-19 vaccine), strategic partnerships in the UK, Canada, and Australia, and the new launch of mFluciva (influenza vaccine). Cost of sales was $318 million (24% of revenue), R&D expenses were $583 million (down 27% YoY), and SG&A expenses were $282 million (up 5% YoY).

• Revenue Growth: Upward revision for full-year 2026 revenue growth to 15%-25%, exceeding the prior framework of up to 10%. Expects an even split between US and international revenue for the full year.
• Cost of Sales: Maintained at $1.7 billion, which includes a $0.9 billion litigation settlement charge.
• R&D Expenses: Downward revision by $200 million to $2.7 billion, driven by wind-down of infectious disease studies and operational efficiencies.
• SG&A Expenses: Maintained flat at approximately $1 billion versus the prior year.
• Operating Expenses: Excluding the $0.9 billion litigation charge, adjusted operating expenses are expected to be $4.5 billion, and cash costs $3.8 billion, both reflecting a $200 million improvement from previous guidance.
• Capital Expenditures: Downward revision to $200 million from the previous range of $200-$300 million.
• Cash Position: Year-end 2026 cash and investments projected at $8.1-$8.3 billion (including financing proceeds); organic cash projection improved to $5.5-$5.7 billion.

• Norovirus Program Halt: The Phase 3 study for mRNA-1403 failed to meet statistical criteria for early success, leading to a pause in enrollment and uncertainty regarding next steps pending regulatory discussions.
• Litigation Costs: A significant $900 million litigation settlement charge impacts cost of sales and overall profitability metrics for 2026.
• Clinical Trial Uncertainty: Future oncology trials (e.g., RCC, lung cancer) remain event-driven with no guaranteed timing or outcomes, despite promising Phase 2 data.
• Competitive Landscape: Potential competitors may leverage AI improvements in neoantigen selection algorithms, though Moderna asserts its proprietary data advantage.
• Regulatory Timelines: Delays in FDA reviews for combination vaccines (mCoFlu) or BLA submissions could impact commercial launch timelines.

Q: Goldman Sachs asked about confidence in upcoming renal cell carcinoma (RCC) Phase 2 results and whether the LNP vehicle contributes to immunogenicity benefits seen in melanoma. / A: CDO David Berman expressed high confidence in RCC due to its sensitivity to T-cell therapies and consistency with melanoma Phase 2 data across TMB subgroups. Regarding LNP immunogenicity, he noted conflicting retrospective analyses from major cancer centers (MD Anderson vs. Memorial Sloan Kettering) and stated there is insufficient evidence to claim the LNP itself drives the strong hazard ratio observed.