Moderna (NASDAQ:MRNA) Chief Executive and Chairman Stéphane Bancel said the company is entering a new phase defined by a broader vaccine portfolio, late-stage oncology and rare disease readouts, cost reductions and a heavy push into artificial intelligence.
Speaking in a conversation hosted by Bernstein U.S. pharma analyst Courtney Breen, Bancel said his view of mRNA’s potential has “increased tremendously” since Moderna’s 2018 IPO, when no mRNA product had yet been approved. He said Moderna now has four FDA-approved products, with another under review, and multiple late-stage readouts expected this year in cancer and rare diseases.
Regulatory Stability and FDA Reviews
Asked about policy uncertainty, FDA leadership changes and vaccine skepticism, Bancel said predictability is important for the industry because of the long investment cycles involved in drug development. However, he said Moderna’s active product reviews have not been significantly affected.
“If you look at the product reviews we’re having, whether it’s a vaccine, whether it’s a rare disease or intismeran, it’s the working team that are in constant discussion with our working team, and those teams are pretty stable,” Bancel said. He added that leadership stability at the agency would be important for longer-term policy questions, including how AI can be used in regulatory filings, clinical trial enrollment and site selection.
Intismeran Data and Oncology Ambitions
Bancel highlighted Moderna’s individualized neoantigen therapy, intismeran, which is being developed with Merck. He said Moderna shared top-line five-year data in January showing a hazard ratio of about 0.5, consistent with the three-year results, and said the company was encouraged that the P value improved over time.
He said full five-year data in melanoma were scheduled for presentation at ASCO, along with translational medicine data focused on T-cell activity. Bancel described earlier work showing that, after treatment, patient T-cells began recognizing neoantigens encoded in the product.
Bancel also pointed to a new Phase 3 study with Merck in stage 1 lung cancer, including arms testing intismeran as monotherapy and in combination with KEYTRUDA. He said Moderna believes earlier-stage disease may be an attractive setting because patients have lower disease burden and stronger immune systems.
He emphasized the therapy’s tolerability profile, saying the safety profile is similar to an infectious disease vaccine, with potential fever or chills. Bancel said the Phase 3 melanoma study of intismeran plus KEYTRUDA was the fastest Phase 3 KEYTRUDA study Merck had ever enrolled, which he attributed to Phase 2 efficacy signals and limited safety downside.
Vaccine Portfolio, Norovirus and Commercial Leverage
Bancel said Moderna remains primarily an infectious disease vaccine business today, with four vaccines approved globally and a potential flu approval this year. If the company’s Phase 3 norovirus trial is positive later this year, he said Moderna would file quickly and the vaccine could be approved next year.
He described norovirus as an important commercial opportunity because no vaccine is currently on the market and because the illness is familiar to many consumers. Bancel identified higher-risk adults, people with comorbidities, healthcare workers, nursing home staff and teachers as potential target populations.
Bancel said having more products would help Moderna negotiate with retail pharmacy customers, noting that in the U.S. the company sells directly to pharmacies such as CVS, Walmart and local pharmacies without a PBM intermediary. He said bundling products could become increasingly important as Moderna launches differentiated vaccines, including flu, combination products and potentially norovirus.
“I don’t need to add one sales rep in the U.S.,” Bancel said, arguing that additional vaccine launches could create leverage across SG&A, manufacturing and R&D. He also said infectious disease vaccine R&D costs should decline as late-stage studies wind down.
Cost Cuts and AI-Driven Operating Changes
Bancel said Moderna has reduced cash costs from about $9 billion to $4.3 billion last year. Breen noted the company’s guidance for $4.2 billion in cash costs this year and a longer-term target of $3.5 billion to $3.9 billion by 2027, which Bancel acknowledged.
He said the first wave of reductions came from manufacturing, including scaling back fill-finish partners and ending a major Lonza drug substance partnership. Moderna also prioritized its R&D portfolio, benefited from infectious disease studies tailing off, restructured the organization and renegotiated supplier costs that had been established during the pandemic.
Bancel said AI will have a “very profound” impact on Moderna’s operations, as the company rethinks business processes across finance, procurement, accounting and other functions. He said Moderna is using AI and internal software tools to redesign workflows that were built quickly during the pandemic.
AI in Drug Discovery
Bancel said Moderna has used machine learning in biology since 2016 or 2017, including to design enzymes used in manufacturing. He said the company created an internal AI academy before the COVID-19 pandemic and later worked with OpenAI on enterprise AI tools.
In science, Bancel said AI could accelerate understanding of biology and help Moderna improve mRNA and lipid design. He said the company is building a feedback loop that uses AI-generated hypotheses, high-throughput lipid testing, animal studies, human data and further learning.
“I’m convinced we have not invented our best drug yet,” Bancel said, citing potential advances in oncology, rare disease and vaccines as the company continues investing in mRNA, AI and related technologies.
About Moderna (NASDAQ:MRNA)
Moderna, Inc is a biotechnology company headquartered in Cambridge, Massachusetts, specializing in messenger RNA (mRNA) therapeutics and vaccines. The company’s platform leverages synthetic mRNA to instruct cells to produce proteins that can prevent or treat diseases. Since its founding in 2010, Moderna has advanced from early-stage research into a broad pipeline of vaccine and therapeutic candidates designed to address infectious diseases, rare genetic disorders and chronic illnesses.
Moderna’s flagship product is its mRNA-based COVID-19 vaccine, which was the first of its kind to receive emergency use authorization and later full approval in multiple jurisdictions.
