Emmanuel Papadakis

Emmanuel Papadakis from Deutsche Bank asked for the assumptions that would lead to the low end of the revised 2025 guidance. He also questioned the development path for the CagriSema co-formulation and its manufacturing requirements.

Answer

CFO Karsten Knudsen explained the low end of the guidance range accounts for unforeseen events like market volatility or significant gross-to-net adjustments, with their base case being closer to the midpoint. EVP Martin Lange clarified that the CagriSema co-formulation will require a clinical equivalence study, not a full Phase III program, and can utilize existing manufacturing capacity.

Emmanuel Papadakis of Deutsche Bank inquired about the Phase II data for remibrutinib in food allergy, its competitiveness versus Xolair, and the expected launch speed for its chronic spontaneous urticaria (CSU) indication.

Answer

CEO Vasant Narasimhan described the food allergy data as 'very compelling' for an oral therapy and stated that head-to-head studies are under evaluation. For the CSU launch, he anticipates strong physician and patient demand due to the drug's rapid onset and sustained efficacy, suggesting the potential for an attractive initial uptake.

Emmanuel Papadakis sought clarification on Pluvicto's peak sales guidance, which was stated as $4 billion but previously guided to $5 billion. He also asked for details on the company's confidence in a second-half sales inflection for the PSMAfore launch, particularly regarding community referral bottlenecks.

Answer

CEO Vasant Narasimhan corrected his earlier statement, confirming Pluvicto's peak sales guidance remains at $5 billion-plus. He explained that the second-half inflection is expected to be driven by rapid uptake in established academic centers, while reaching full potential will require expanding the number of sites and increasing patient volume in community settings by addressing staffing, reimbursement, and referral challenges.

Emmanuel Papadakis of Deutsche Bank asked about the accelerated readout for ianalumab in Sjogren's syndrome, inquiring about the drivers of this confidence and the company's view on the necessary magnitude of ESSDAI improvement for success.

Answer

CEO Vasant Narasimhan explained the readout was pulled forward due to faster-than-expected enrollment. He expressed confidence that repeating the Phase IIb results, which showed significant ESSDAI improvement, would be compelling. Narasimhan emphasized that beyond the ESSDAI composite endpoint, demonstrating benefits in patient-reported outcomes like salivary gland function and dry eye will be critical for establishing ianalumab as a multibillion-dollar opportunity.

Emmanuel Papadakis of Deutsche Bank asked about the potential for mid-term operating margin leverage and inquired about the strategy for balinatunfib (oral TNF) following its upcoming psoriasis data.

Answer

CFO François-Xavier Roger indicated that while strong growth and rising gross margins are expected, the BOI margin could face pressure in 2027 from the Regeneron profit share change, though absolute BOI will grow annually. Executive Houman Ashrafian explained that balinatunfib has potential as both a monotherapy and in combination strategies, including with Sanofi's internal assets, with key RA data also expected later in the year.

Emmanuel Papadakis asked about expectations for an upcoming Imfinzi advisory committee meeting and the rationale for the trial design. He also inquired about the potential timing and magnitude of a price reduction for Farxiga in China under VBP.

Answer

EVP, Oncology R&D, Susan Galbraith, noted the trial met its primary endpoints and that the FDA wants a broader discussion on future perioperative trial designs. EVP, International and China President, Leon Wang, stated that while uncertain, any VBP for Farxiga would likely occur late in the year with a price cut that is typically under 30%.