Sarita Kapila

Sarita Kapila of Morgan Stanley asked about the revenue potential for Imfinzi in bladder and gastric cancer, competitive positioning against Padcev, and how Enhertu will be integrated into first-line HER2-positive breast cancer treatment.

Answer

EVP of Oncology Business, David Fredrickson, characterized both the bladder and gastric cancer opportunities for Imfinzi as blockbuster potentials, noting the importance of the VOLGA study in the competitive landscape. He expects Enhertu to be used in line with the DB-09 'treat to progression' protocol, given its superior PFS data. CEO Pascal Soriot added that medical practice should be guided by trial data, not speculation on alternative treatment regimens.

Sarita Kapila asked about the full-year impact of the Medicare Part D redesign on the U.S. oncology business and sought details on the AVANZAR trial, including confidence in its QCS biomarker and the rationale for using Imfinzi as a backbone.

Answer

EVP, Oncology Business Unit, David Fredrickson characterized the Part D impact as a one-time "rebasing" in Q1, against which strong underlying volume growth of over 20% for drugs like Tagrisso and Calquence is occurring. CEO Pascal Soriot reinforced this volume growth outlook. EVP, Oncology R&D, Susan Galbraith expressed high confidence in the AVANZAR trial's biomarker, citing mechanistic understanding and corroborating data from other trials, and defended the use of Imfinzi based on its proven track record.

Sarita Kapila asked how to interpret amlitelimab's upcoming readouts, specifically if the placebo arm in the COAST-2 trial would behave more normally or if it's a pure sister trial to COAST-1, and what underpins confidence in long-term efficacy improving over time beyond the no plateau seen in COAST-1.

Answer

Houman Ashrafian (Head of R&D) confirmed that COAST-2 is a 'precise replica sister study' to COAST-1, with subtle regional differences, and they anticipate a similar outcome. He added that the Esteri study, with readouts next year, will provide critical insights into durability and the relationship between dose and durability, informing amlitelimab's positioning.

Sarita Kapila asked about the upcoming amlodipine readouts, specifically if the COAST2 trial's placebo arm is expected to behave similarly to COAST1, and what underpins confidence in Esteri's long-term efficacy improvement beyond the observed no plateau.

Answer

Head of R&D Houman Ashrafian confirmed that COAST2 is a precise replica sister study to COAST1, with expectations for similar results. He explained that Esteri will provide critical insights into durability and the relationship between dose and durability through its multiple dose-switching arms, which will inform amlodipine's positioning.

Sarita Kapila from Morgan Stanley asked if flat margins in 2026 should be seen as a floor and if the peak sales forecast for AYVAKIT adequately accounts for competition.

Answer

CFO François Roger declined to guide for 2026 but confirmed expectations for continued asset disposal gains. EVP & Head of Specialty Care Brian Foard expressed confidence in the AYVAKIT forecast, noting the market is underpenetrated and that the guidance already factors in future competition, highlighting AYVAKIT's strong profile.

Sarita Kapila of Morgan Stanley asked about U.S. flu vaccine dynamics, including softer demand and pricing pressure, and whether this implies another year of sales decline. She also inquired about Sanofi's view on pursuing trispecific antibodies in atopic dermatitis.

Answer

Thomas Triomphe (EVP, Chief Business Officer) confirmed that softer demand and price competition are being observed in U.S. flu pre-bookings but said it was too early to be definitive. Houman Ashrafian (EVP, Head of R&D) acknowledged that Sanofi has explored trispecifics but cautioned about their complexity, emphasizing that the large, underpenetrated atopic dermatitis market has substantial room for many new molecules.

Sarita Kapila asked about GSK's long-term HIV strategy, specifically regarding the development of long-acting orals and their potential impact on the company's injectable-focused pipeline.

Answer

ViiV Chairman David Redfern affirmed that GSK's primary focus is on longer-acting injectables, building on its first-mover advantage and advancing its pipeline toward 4-month and 6-month options with assets like VH184. He stated that while GSK monitors long-acting orals, the company believes they will mainly cannibalize daily orals and that clear patient preference supports the injectable strategy.