Moderna, Inc.: Q3 FY2026 earnings call
What management said about Q3 FY2026, from the documents filed with the SEC on 6 November 2026: press release. Guidance figures: 1 raised, 2 lowered, 1 narrowed, 2 kept. The quarter’s numbers.
Key takeaways
- Revenue rose 29% year over year: Revenue reached $1.3 billion, up from $1.0 billion a year earlier, mainly from higher international COVID vaccine sales tied to long-term government partnerships. Source
- R&D fell 27% on completed studies: R&D was $583 million, down 27%, mainly from lower clinical development costs after late-stage infectious disease studies wound down, plus organization-wide cost efficiencies. Source
- Net income of $162 million: Net income was $162 million, compared with a net loss of $200 million a year earlier, a $362 million improvement. Source
- Cash rose to $8.0 billion: Cash, cash equivalents and investments were $8.0 billion at September 30, up from $6.9 billion at June 30. Source
- MFLUSIVA approved in U.S.: FDA approved mFLUSIVA in August for adults aged 50 - 64 and granted accelerated approval for adults 65 and older. Canada approval was also received. Source
- Intismeran Phase 3 melanoma data positive: In the INTerpath-001 Phase 3 study in resected high-risk melanoma, intismeran with KEYTRUDA lowered the risk of recurrence or death by 42% versus KEYTRUDA alone. Source
“We delivered 29% revenue growth in the third quarter, alongside the U.S. approval of mFLUSIVA, our fifth approved product globally, and positive Phase 3 results for intismeran in melanoma,”
Stéphane Bancel, Chief Executive Officer of Moderna
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Cost of sales Source | full year 2026 | approximately $1.7 billion, including $0.9 billion litigation settlement charge | Kept |
| Research and development expenses Source | full year 2026 | approximately $2.7 billion | Lowered from approximately $2.9 billion |
| Selling, general and administrative expenses Source | full year 2026 | approximately $1.0 billion | Kept |
| GAAP operating expenses Source | full year 2026 | approximately $0.2 billion improvement from previous estimate | Lowered |
| Capital expenditures Source | full year 2026 | approximately $0.2 billion | Narrowed, top end cut from $0.2 billion to $0.3 billion |
| Year-end cash and investments Source | year-end 2026 | $8.1 billion to $8.3 billion | Raised from $4.7 billion to $5.2 billion |
What changed from last quarter
- Guidance raised: Full-year 2026 revenue growth guidance raised to 15% to 25% from up to 10%. Source
- Guidance raised: Year-end 2026 cash and investments guidance raised to $8.1 billion to $8.3 billion from $4.7 billion to $5.2 billion. Source
- Guidance lowered: Full-year 2026 R&D expense guidance lowered to about $2.7 billion from about $2.9 billion. Source
- Guidance lowered: The 2026 GAAP operating expense estimate was improved by about $0.2 billion. Source
- Guidance lowered: Full-year 2026 capital expenditure guidance narrowed to about $0.2 billion from $0.2 billion to $0.3 billion. Source
- New: Five-year agreement signed in September with a local manufacturer in Mexico for COVID-19 vaccines. Source
- New: U.S. FDA approved mFLUSIVA, the seasonal influenza vaccine, in August; it is the company's fifth approved product globally. Source
- New: Moderna and GSK agreed on October 28, 2026 to settle all pending U.S. and European disputes, with patent cross-licenses and no payments. Source
- New: Norovirus Phase 3 interim analysis did not meet early-success criteria; no additional cohort planned this season. Source
- New: Juan Andres appointed Chief Operating Officer, effective October 5, 2026. Source
- New: Convertible senior notes offering of about $3.0 billion principal completed in September. Source
- Ended: Jerh Collins, Chief Technical Operations and Quality Officer, retired after four years with the company. Source
Results and growth drivers
- Revenue rose 29% year over year: Revenue reached $1.3 billion, up from $1.0 billion a year earlier, mainly from higher international COVID vaccine sales tied to long-term government partnerships. Source
- COVID launch and respiratory portfolio: Updated COVID vaccine launches and an expanded approved respiratory vaccine portfolio supported the quarter, alongside international partnerships. Source
Regions, partnerships and settlement
- U.S. and international revenue split: Third-quarter revenue was $780 million in the U.S. and $533 million in international markets. Source
- Partnerships in three countries: Management cited execution of international strategic partnerships with the United Kingdom, Canada and Australia as part of the revenue growth strategy. Source
- Mexico manufacturing agreement signed: A five-year COVID-19 vaccine agreement with a Mexican local manufacturer was signed in September, which management said supports recurring revenue. Source
- GSK disputes settled: Moderna and GSK settled all pending U.S. and European disputes, granting patent cross-licenses in infectious disease with no payment obligations. Source
“Building on this momentum, we increased our full-year revenue growth outlook to 15%-25%, while continuing to reduce costs and strengthen our balance sheet.”
Stéphane Bancel, Chief Executive Officer of Moderna
Costs and operating expenses
- Cost of sales rose 54%: Cost of sales was $318 million, including $65 million of third-party royalties, up 54% on higher product sales volume and other manufacturing-related costs. Source
- R&D fell 27% on completed studies: R&D was $583 million, down 27%, mainly from lower clinical development costs after late-stage infectious disease studies wound down, plus organization-wide cost efficiencies. Source
- SG&A rose 5%: SG&A was $282 million, up 5% year over year. Management said it continues to maintain cost discipline across the organization. Source
Earnings and taxes
- Net income of $162 million: Net income was $162 million, compared with a net loss of $200 million a year earlier, a $362 million improvement. Source
- Diluted EPS of $0.38: Diluted EPS was $0.38, compared with a loss of $0.51 per share in the third quarter of 2025. Source
- Tax provisions not material: Income tax provisions were not material in either period because a global valuation allowance covers most deferred tax assets. Source
“Looking ahead, we anticipate additional intismeran readouts, pivotal data in propionic acidemia and further regulatory approvals as we advance our pipeline and build a more diversified company.”
Stéphane Bancel, Chief Executive Officer of Moderna
Cash, debt and financing
- Cash rose to $8.0 billion: Cash, cash equivalents and investments were $8.0 billion at September 30, up from $6.9 billion at June 30. Source
- Litigation payment offset the increase: The cash increase reflected convertible note proceeds, partly offset by a $950 million litigation settlement payment and cash used in operations. Source
- Third-quarter receivables largely uncollected: Seasonal working capital from third-quarter product sales weighed on operating cash, with most of those receivables still uncollected at quarter-end. Source
- Credit facility capacity remains: About $0.9 billion remains available under the credit facility, and the year-end cash guidance excludes any further drawdowns. Source
Pipeline and regulatory milestones
- MFLUSIVA approved in U.S.: FDA approved mFLUSIVA in August for adults aged 50 - 64 and granted accelerated approval for adults 65 and older. Canada approval was also received. Source
- Intismeran Phase 3 melanoma data positive: In the INTerpath-001 Phase 3 study in resected high-risk melanoma, intismeran with KEYTRUDA lowered the risk of recurrence or death by 42% versus KEYTRUDA alone. Source
- Flu and COVID combination approvals: The flu and COVID combination vaccine received approval in Canada as mCOFLU, following EU approval as mCOMBRIAX. Other markets remain under review. Source
- Norovirus program path unresolved: The norovirus Phase 3 interim analysis did not meet early-success criteria, so no additional cohort starts this season. The company will engage health authorities. Source
- Methylmalonic acidemia pivotal decision deferred: The decision on starting a pivotal study for mRNA-3705 in methylmalonic acidemia is deferred until the propionic acidemia registrational readout. Source
Corporate, leadership and recognition
- New Chief Operating Officer: Juan Andres, who previously held senior roles at Moderna, took the Chief Operating Officer role on October 5 and oversees operations, including global manufacturing. Source
- Technical operations officer retired: Jerh Collins, Chief Technical Operations and Quality Officer, retired after four years with the company. Source
- Named to Fortune list: Moderna was named to Fortune's 2026 Change the World list, which the company said recognizes its impact through mRNA medicines. Source
Coming up, as management said on 6 November 2026
- Analyst Day on November 12: Moderna's Analyst Day is scheduled for November 12, 2026, following the investor call held on November 6. Source
- Propionic acidemia pivotal data expected: Pivotal data from the registrational study of mRNA-3927 in propionic acidemia are expected in 2026, now that target enrollment is reached. Source
- Intismeran regulatory filings and launch preparation: Moderna and Merck are working toward regulatory submissions for intismeran and preparing for a potential commercial launch, subject to approval. Source
- Limited mFLUSIVA launch for 2026 - 2027 season: A limited U.S. launch of mFLUSIVA is planned for the 2026 - 2027 influenza season, with approval occurring after the annual contracting cycle. Source
- MRNA-2808 oral presentation in December: An abstract for mRNA-2808 was accepted for oral presentation at the American Society of Hematology meeting on December 12 in New Orleans. Source
Figures management reported
| Figure | Reported |
|---|---|
| Net product sales Source | $1,273 million in Q3 2026, $973 million in Q3 2025; nine months $1,719 million |
| R&D spend Source | $583 million in Q3 2026, down 27% year over year |
| FDA approval Source | mFLUSIVA approved in August 2026; fifth approved product globally |
| Phase 3 trial readout Source | Intismeran with KEYTRUDA: 42% lower risk of recurrence or death (HR 0.58) |
| Regulatory approval Source | mCOFLU approved in Canada; mCOMBRIAX approved in the EU |
Risks management discussed
- Regulatory: The norovirus program has no agreed path forward after the interim analysis missed early-success criteria; management will engage health authorities. Source
- Regulatory: The U.S. refiling of the flu and COVID combination vaccine depends on further FDA guidance, which the company is still awaiting. Source
- Demand: The mFLUSIVA U.S. launch is limited for the 2026 - 2027 season because approval comes after the annual contracting cycle. Source
Earlier plans management reported on
- Not stated: Positive Phase 3 intismeran melanoma results were presented at ESMO in October, the data timing previously expected for 2026. Source
- Not stated: The registrational study has reached target enrollment, and pivotal data are still expected in 2026, as previously guided. Source
- Not stated: The company had previously planned to enroll an additional norovirus cohort. It now does not plan to start one this season. Source
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.