What Moderna (MRNA) Said on Its Q3 Earnings Call

Key Points

• Moderna raised its 2026 revenue growth outlook after Q3 revenue rose 29% to $1.3 billion and it returned to profit, earning $162 million. The CFO cited growth of 15%–25%, while the CEO later cited 15%–20%; the difference was not addressed.
• Moderna and Merck plan to seek U.S. approval this year for their personalized melanoma therapy after a Phase III trial found the combination reduced the risk of recurrence or death by 42% versus pembrolizumab alone.
• The company received U.S. approval for its flu vaccine for adults 50 and older, but paused plans to enroll another cohort in its norovirus vaccine study after interim results failed to meet criteria for early success.

Moderna NASDAQ: MRNA raised its 2026 revenue growth outlook after reporting higher third-quarter sales and a return to quarterly profitability, as demand for its COVID-19 vaccines and international partnerships supported results.

The company reported revenue of $1.3 billion, up 29% from a year earlier, primarily because of higher COVID-19 vaccine sales. Net income was $162 million, or 38 cents per diluted share, compared with a loss of 51 cents per share in the prior-year quarter.

Chief Financial Officer Jamey Mock said Moderna now expects full-year revenue growth of 15% to 25%, up from its previous framework of up to 10%. Chief Executive Officer Stéphane Bancel later cited a range of 15% to 20% in his closing remarks. The difference was not addressed on the call.

Revenue Outlook and Spending

Mock said both U.S. and international sales exceeded expectations in the third quarter, reflecting increased demand, operational execution and the timing of shipments between the third and fourth quarters. Approximately 60% of quarterly revenue came from the U.S. and 40% from international markets.

Year-to-date international revenue reached $900 million, exceeding Moderna’s international revenue for all of 2025 by $200 million. Mock pointed to increased adoption of the mNEXSPIKE COVID-19 vaccine in the U.S. and performance from partnerships in the U.K., Canada and Australia. For the full year, Moderna continues to expect an approximately even split between U.S. and international revenue.

Research and development expenses fell 27% year over year to $583 million in the third quarter, reflecting the completion and wind-down of infectious disease studies and efficiency gains. Selling, general and administrative expenses rose 5% to $282 million.

Moderna lowered its full-year R&D expense estimate by $200 million to $2.7 billion and reduced its capital expenditure estimate to $200 million from a previous range of $200 million to $300 million. Excluding a $900 million litigation charge, the company expects $4.5 billion in total GAAP operating expenses and $3.8 billion in cash costs, each $200 million below its previous framework.

Cash and investments stood at $8 billion at quarter-end, up from $6.9 billion at the end of the second quarter. The increase included approximately $2.6 billion in net proceeds from a convertible note issuance and capped call transaction, partly offset by a $950 million litigation settlement payment and seasonal working capital effects.

Moderna now expects year-end cash and investments of $8.1 billion to $8.3 billion. Excluding the financing proceeds, its projected range would be $5.5 billion to $5.7 billion, above the prior outlook of $4.7 billion to $5.2 billion.

Melanoma Filing and Cancer Pipeline

Moderna and partner Merck are working to submit a biologics license application this year for intismeran autogene, an individualized cancer therapy, after a positive phase III study in patients with resected melanoma. President Stephen Hoge said the companies would hope for approval next year if the process goes well.

Chief Development Officer David Berman said the trial enrolled more than 1,100 patients with resected Stage IIB through IV melanoma. Intismeran combined with pembrolizumab reduced the risk of recurrence or death by 42% compared with pembrolizumab alone at the first interim analysis. At two years, recurrence-free survival was 82.2% for the combination, versus 70% for pembrolizumab alone.

A prespecified analysis limited to patients who received the intended intismeran or placebo injection showed a 49% reduction in the risk of recurrence or death. Berman said the combination was generally well tolerated, with findings consistent with the known safety profiles of the individual therapies. The most common adverse events in the combination group were fever, injection-site pain and fatigue.

Another intismeran milestone is an event-driven phase II study in renal cell carcinoma. Berman said an interim readout could come at the end of 2026 or early 2027. He said a positive result could inform practice, while a particularly strong result might warrant discussion with the U.S. Food and Drug Administration about registration; that decision would depend on the data.

In a phase I pancreatic cancer study, Moderna reported neoantigen-specific T-cell responses in all 19 evaluable patients. Berman cautioned that it was too early to draw an efficacy conclusion from the single-arm study and said the companies were discussing next steps.

Vaccine Portfolio and Other Programs

Moderna received U.S. FDA approval for its influenza vaccine mFLUSIVA for adults ages 50 to 64 and accelerated approval for adults 65 and older. The company also secured Canadian approvals for mFLUSIVA and its combination flu and COVID-19 vaccine, marketed there as mCOFLU, for adults 60 and older.

Hoge said Moderna expects to discuss U.S. submission requirements for the combination vaccine with the FDA in the coming months. The product is approved in Europe and Canada and remains under review in several other markets.

For its norovirus vaccine candidate, Moderna decided not to enroll an additional cohort during the coming winter season after a phase III study failed to meet the statistical criteria for early success at an interim analysis. Hoge said the company is consulting health authorities before determining next steps.

Moderna also expects results later this year from its registrational trial in propionic acidemia. It has deferred a decision on starting a pivotal trial in methylmalonic acidemia until after that readout. Initial clinical results for its multiple myeloma program, mRNA-2808, are scheduled for an oral presentation at the American Society of Hematology’s annual meeting in December.

About Moderna (NASDAQ:MRNA)

Moderna, Inc is a biotechnology company that develops medicines and vaccines using messenger RNA (mRNA) technology. Its platform is designed to instruct cells to produce proteins that can stimulate immune responses or support the treatment of disease. The company's research programs span infectious diseases, immuno-oncology, rare diseases, autoimmune conditions and other therapeutic areas.

Moderna's commercial products include Spikevax, an mRNA vaccine for COVID-19, and mRESVIA, an mRNA vaccine for respiratory syncytial virus (RSV) in older adults.

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