Michael Leuchten

Michael Leuchten of Jefferies asked whether the strong Q2 oncology performance was achieved despite a weaker-than-expected volume uplift from the Medicare Part D redesign, a dynamic noted by a competitor.

Answer

EVP of Oncology Business, David Fredrickson, stated that the Part D redesign impact played out consistently with their expectations. He described it as a 'rebasing event' where the gross-to-net impact was offset by lower abandonment rates. He highlighted strong sequential demand-driven growth for Calquence (15% in the US) and Tagrisso (12% in the US) post-rebasing, indicating the volume dynamics were in line with their plan.

Michael Leuchten sought further clarification on the seasonality of gross margin, specifically what 'return to normal patterns' implies after Dupixent's manufacturing process is fully integrated. He also questioned why Sanofi did not raise its full-year guidance despite strong Q3 performance.

Answer

CFO François-Xavier Roger clarified that the 2.5 percentage point gross margin increase in Q3 is not a proxy for 2026, with an underlying increase of ~1% expected from volume and product mix. He reiterated the full-year guidance of high single-digit sales growth and low double-digit business EPS growth, expecting Q4 to be the strongest quarter. He also highlighted that Regeneron profit sharing grows significantly faster than Dupixent sales (e.g., 11 percentage points faster in H1 and Q3).

Michael Leuchten asked François-Xavier Roger about the seasonality comment on gross margin, specifically what 'return to normal patterns' meant after the Dupixent process, and why Sanofi opted not to increase its full-year guidance despite Q3 gross margin drivers.

Answer

François-Xavier Roger (CFO) clarified that the 2.5% Q3 gross margin increase is not a proxy for 2026, with an underlying increase of about 1% expected from volume and product mix. He confirmed full-year guidance (high single-digit sales, low double-digit EPS excluding buyback), expecting Q4 to be the best quarter. He also highlighted that Regeneron profit sharing grows faster than Dupixent sales (e.g., Q3 Dupixent sales +26%, profit sharing +37%).

Michael Leuchten of Jefferies asked if Novo Nordisk would provide an outlook for 2026 with its Q3 results, given the many variables. He also later questioned the confidence in amicretin's Phase III dose selection and whether there was flexibility to change it.

Answer

Karsten Knudsen, EVP & CFO, stated that 2026 guidance would be provided with the full-year results, not at Q3, but offered building blocks including the oral semaglutide launch and a low single-digit LOE impact. On amicretin, Martin Lange, EVP & Chief Scientific Officer, expressed confidence in the chosen doses and titration steps, noting the Phase III design has built-in flexibility and that they have had productive dialogues with regulators.

Michael Leuchten of Jefferies asked if Novo Nordisk would be in a position to provide a 2026 outlook with its Q3 results. He also questioned the company's confidence in its Phase 3 dose selection for amicretin, given recent competitor data.

Answer

Karsten Knudsen (CFO) confirmed that 2026 guidance would be provided with the full-year results, per standard practice, but offered building blocks including a low single-digit top-line impact from LOE. Regarding amicretin, Martin Lange (CSO) expressed confidence in the chosen doses and titration schedule, noting the Phase 3 program has built-in flexibility and has been discussed with regulators.

Michael Leuchten asked for clarification on Q2 supply chain costs impacting COGS and their effect on the H2 gross margin outlook. He also questioned if peak sales expectations for Nucala in COPD had been lowered.

Answer

CFO Julie Brown stated that despite supply chain charges and anticipated tariffs, she expects full-year gross margin accretion driven by the specialty product mix. CCO Luke Miels confirmed the £500M peak sales figure for Nucala in COPD is a fair starting point, but the company aims higher, citing positive early physician feedback. CEO Dame Emma Walmsley emphasized the broader strategy is leadership across the entire COPD portfolio.

Michael Leuchten from Jefferies asked about the performance of Fabhalta in IgAN and C3G, noting that the company's framing of the opportunity seemed conservative and asking what might lead to a more optimistic outlook.

Answer

CEO Vasant Narasimhan clarified that Novartis is very optimistic about Fabhalta and its potential to achieve significant peak sales. He explained that the growth trajectory is expected to be a steady, indication-by-indication build-up rather than a sharp, rapid inflection, as the company establishes the drug in IgAN, C3G, and PNH.