Moderna — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $1.3 billion, a 29% increase year-over-year compared to $1.0 billion in Q3 2025; GAAP net income was $0.2 billion with diluted EPS of $0.38, contrasting with a net loss of $(200) million and loss per share of $(0.51) in the prior year period.
• Cost of sales increased 54% to $318 million in Q3 2026 from $207 million in Q3 2025, driven by higher product sales volume and manufacturing costs, including $65 million in third-party royalties.
• Research and development expenses decreased 27% to $583 million in Q3 2026 from $801 million in Q3 2025, attributed to lower clinical development costs following the wind-down of late-stage infectious disease studies.
• Selling, general, and administrative expenses rose 5% to $282 million in Q3 2026 from $268 million in Q3 2025.
• Cash, cash equivalents, and investments stood at $8.0 billion as of September 30, 2026, up from $6.9 billion as of June 30, 2026, reflecting $2.6 billion in net proceeds from convertible notes issuance partially offset by a $950 million litigation settlement payment.
• Deferred revenue increased to $268 million (current) and $139 million (non-current) as of September 30, 2026, compared to $99 million and $153 million respectively in the prior year.
• Long-term debt increased to $591 million as of September 30, 2026, from $590 million in December 2025, with $2.958 billion in convertible notes recorded as a liability.

Guidance and Future Outlook:

• Full-year 2026 revenue growth outlook was increased to 15%–25%, exceeding the previous expectation of up to 10% growth.
• 2026 GAAP operating expense outlook was improved by approximately $0.2 billion, with R&D expenses reduced to approximately $2.7 billion (from $2.9 billion) and SG&A remaining at approximately $1.0 billion.
• 2026 cost of sales is expected to be approximately $1.7 billion, including a $0.9 billion non-recurring litigation settlement charge.
• Year-end 2026 cash and investments are now expected to be $8.1 billion to $8.3 billion, up from a previous outlook of $4.7 billion to $5.2 billion.
• Capital expenditures for 2026 are expected to be approximately $0.2 billion, revised down from a previous expectation of $0.3 billion.
• The company anticipates additional intismeran readouts, pivotal data in propionic acidemia, and further regulatory approvals to advance its pipeline.

Business Segments and Product Lines:

• Revenue was split between $780 million in the U.S. and $533 million in international markets, driven by higher COVID vaccine sales in international markets under long-term strategic government partnerships.
• mFLUSIVA received U.S. FDA approval for adults aged 50–64 and accelerated approval for adults 65+, marking the company's fifth approved product globally, with a limited U.S. launch for the 2026–2027 season.
• mCOFLU (flu/COVID combination vaccine) received regulatory approval in Canada and the EU (as mCOMBRIAX), with ongoing reviews in Japan, the UK, and Australia.
• Intismeran (mRNA-4157) presented positive Phase 3 results in resected high-risk melanoma, showing a 42% reduction in risk of recurrence or death compared to KEYTRUDA alone.
• The Norovirus vaccine (mRNA-1403) did not meet statistical criteria for early success in Phase 3 interim analysis, and no additional cohorts will be initiated this season.
• Propionic acidemia (mRNA-3927) registrational study reached target enrollment with pivotal data expected in 2026.

Market and Competitive Landscape:

• The company executed international strategic partnerships with the United Kingdom, Canada, and Australia, and signed a five-year agreement with a local manufacturer in Mexico for COVID-19 vaccines.
• Moderna and Merck are preparing for regulatory submissions and a potential commercial launch of intismeran, subject to approval.
• The company maintains a global valuation allowance against most deferred tax assets, resulting in negligible income tax provisions for the period.

Risks and Challenges:

• The Norovirus vaccine program (mRNA-1403) faced a Phase 3 interim analysis failure to meet statistical criteria for early success.
• A $950 million payment related to a litigation settlement was made in the first quarter of 2026, impacting cash flow.
• The company faces risks related to regulatory approvals, including pending FDA guidance on refiling mCOFLU in the United States.
• Forward-looking statements involve known and unknown risks, uncertainties, and factors that could cause actual results to differ materially from expectations.

Management Commentary and Tone:

• CEO Stéphane Bancel stated the company delivered 29% revenue growth alongside the approval of mFLUSIVA and positive Phase 3 results for intismeran.
• Management emphasized building momentum by increasing the full-year revenue growth outlook while continuing to reduce costs and strengthen the balance sheet.
• The tone reflected confidence in advancing the pipeline to build a more diversified company, with a focus on operational strategy and execution under new leadership.

Other Key Points:

• In September, Moderna appointed Juan Andres as Chief Operating Officer, effective October 5, 2026, to oversee operational strategy and global manufacturing.
• Jerh Collins, Ph.D., retired as Chief Technical Operations and Quality Officer in September after four years with the company.
• In September, Moderna completed a convertible senior notes offering totaling approximately $3.0 billion in principal, raising $2.6 billion in net proceeds after accounting for capped calls and fees.
• Moderna and GSK entered into an agreement on October 28, 2026, to settle all disputes, granting patent cross-licenses in the field of infectious disease with no payment obligations.
• Moderna was named to Fortune's 2026 Change the World list and recognized as a top employer in Science and Science Careers' 2026 Top Employers Survey for the twelfth consecutive year.
• The company will host its 2026 Analyst Day on November 12, 2026.