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Moderna raises outlook as melanoma data adds fresh growth potential

Biotechnology By Ada Torres 4 min read

Moderna returned to quarterly GAAP profit, raised its 2026 revenue growth outlook and reported positive Phase 3 melanoma data. The stronger quarter was supported by international COVID vaccine sales, while cash generation and pipeline execution remain important tests.

  • Third-quarter revenue up 29% to US$1.313 billion
  • GAAP net income of US$162 million versus a US$200 million loss
  • 2026 revenue growth outlook lifted to 15% to 25%
  • Year-end cash and investments forecast raised to US$8.1 billion to US$8.3 billion
  • Positive melanoma data offset by a stalled early norovirus readout

Revenue Growth Restores Quarterly Profit

Moderna (NASDAQ:MRNA) has turned a strong vaccine quarter into a materially brighter 2026 outlook, reporting US$1.313 billion of third-quarter revenue, up 29% from a year earlier, and GAAP net income of US$162 million. The result compares with a US$200 million loss in the same quarter of 2025, while diluted earnings per share swung to US$0.38 from a loss of US$0.51.

The revenue lift came primarily from higher COVID vaccine sales in international markets, including deliveries under long-term government partnerships. US revenue was US$780 million and international revenue US$533 million. The improvement was not costless: cost of sales rose 54% to US$318 million, including US$65 million in third-party royalties, but research and development spending fell 27% to US$583 million after the completion or wind-down of certain late-stage infectious disease studies.

2026 Revenue and Cash Guidance Raised

Moderna now expects total 2026 revenue growth of 15% to 25%, up from its previous expectation of no more than 10%. It also reduced expected full-year research and development expense to approximately US$2.7 billion from US$2.9 billion, while trimming its capital expenditure range to about US$200 million.

The company expects to finish the year with US$8.1 billion to US$8.3 billion in cash and investments, sharply above its previous US$4.7 billion to US$5.2 billion range. That forecast includes approximately US$2.6 billion of net proceeds from September’s convertible notes financing, but excludes further drawdowns from roughly US$900 million remaining under its credit facility. The balance sheet is therefore stronger in headline terms, although the financing added almost US$3.0 billion of convertible notes and the company used US$2.715 billion in operating cash during the first nine months.

Melanoma Data Provides a Second Growth Narrative

The quarter also brought a potentially important clinical update. Moderna and Merck reported Phase 3 results for intismeran autogene, also known as mRNA-4157, in resected high-risk melanoma. In the intention-to-treat population, the combination with KEYTRUDA reduced the risk of recurrence or death by 42% and the risk of distant metastasis or death by 38% compared with KEYTRUDA alone.

The company said the benefit was greater after six months, following the intismeran immunisation regimen, with a 58% reduction in recurrence or death in a pre-specified sensitivity analysis. These are company-reported trial results, and any commercial value still depends on regulatory submissions, review and a potential launch. Moderna said it and Merck are preparing for those next steps.

Commercial Portfolio Expands as Norovirus Programme Stalls

Moderna also received US approval for mFLUSIVA, its seasonal influenza vaccine, for adults aged 50 to 64 and accelerated approval for adults aged 65 and older. The product is being launched on a limited basis for the 2026-27 influenza season because approval came after the annual contracting cycle. Its flu and COVID combination vaccine has also won approvals in Canada and the European Union, while reviews continue in Japan, the United Kingdom and Australia.

The pipeline is not uniformly positive. An interim Phase 3 analysis of the mRNA-1403 norovirus vaccine failed to meet the statistical criteria for early success, and Moderna does not plan to add another cohort this season. The company intends to discuss the programme’s future with health authorities. Meanwhile, pivotal data from the propionic acidemia programme is expected in 2026, and the decision on whether to begin a pivotal methylmalonic acidemia study has been deferred until that readout.

Analyst Day Puts Execution Under the Microscope

Moderna’s next scheduled investor milestone is its Analyst Day on November 12. By then, the central questions will be less about the headline quarter than about durability: how much of the revised revenue outlook rests on seasonal COVID demand and government deliveries, how quickly receivables convert into cash, and whether lower research spending can coexist with the company’s stated oncology and rare disease ambitions.

Bottom Line?

The raised outlook and melanoma data improve Moderna’s near-term narrative, but sustained operating cash use, convertible debt and uneven pipeline results leave execution as the next test.

Questions in the middle?

  • How much of the 15% to 25% 2026 revenue growth range depends on seasonal and government-linked COVID vaccine demand?
  • Can Moderna convert its elevated accounts receivable and quarterly profit into sustained operating cash generation?
  • Will intismeran’s Phase 3 melanoma results translate into regulatory submissions and a commercially viable launch with Merck?

Sources