Florent Cespedes

Florent Cespedes inquired about Novo Nordisk's perspective on the Medicare opportunity for broader obesity coverage and the potential risks or next steps related to the Inflation Reduction Act (IRA).

Answer

EVP of US Operations Dave Moore highlighted the significant Medicare opportunity, noting approximately 30 million Medicare-eligible individuals suffer from obesity, and emphasized the importance of access to anti-obesity medicines for this population. Regarding the IRA, he stated that Novo Nordisk is under strict confidentiality with CMS and cannot comment on specifics, with CMS expected to make announcements on prices in the near future.

Florent Cespedes inquired about Novo Nordisk's perspective on the Medicare channel, specifically regarding the opportunity for broader obesity coverage and the potential risks or next steps related to the Inflation Reduction Act (IRA).

Answer

EVP of US Operations, Dave Moore, emphasized the importance of the Medicare opportunity, noting approximately 30 million Medicare-aged individuals with obesity who need access to anti-obesity medicines. He stated that the company cannot speculate on the potential reach but views it as a very important development. Regarding the IRA, he mentioned that Novo Nordisk is under strict confidentiality with CMS and cannot comment on specific pricing, with CMS making announcements in the near future.

Florent Cespedes asked about the expected ramp-up of remibrutinib, considering its clean safety profile and convenient administration, and the outlook for adoption in Europe given potential comparisons to cheaper drugs.

Answer

Vasant Narasimhan, CEO of Novartis, explained that initial focus is on sampling and payer negotiations for broad access in early next year, expecting rapid uptake from Q2 onwards. The goal is to position remibrutinib pre-biologic. In Europe, he emphasized holding the line on appropriate reimbursement for its innovation, not comparing it to old generics, and expressed optimism for rapid uptake among allergists and dermatologists for a safe oral option.

Florent Cespedes asked about the expected ramp-up of remibrutinib, considering its clean safety profile and convenient administration, and the outlook for adoption in Europe given potential comparisons to cheaper drugs.

Answer

CEO Vasant Narasimhan explained that the initial focus for remibrutinib is on sampling and payer negotiations for broad access in early next year, expecting rapid uptake from Q2 onwards. He stated the long-term goal is to position it pre-biologic. In Europe, he emphasized the importance of appropriate reimbursement for its innovation, not comparison to older generics, and expressed optimism for rapid uptake given allergist and derm community enthusiasm for a safe oral option.

Florent Cespedes of Bernstein asked for an update on the US litigation for Entresto, including timelines for court decisions, upcoming patent expirations, and the company's view on the IRA impact.

Answer

CEO Vasant Narasimhan outlined the three ongoing legal cases against a single generic filer but declined to speculate on timelines. He reiterated that Entresto is expected to face IRA price negotiation in 2026, but the anticipated price is in line with current net pricing, meaning any delay in generic entry continues to represent a financial upside.

Florent Cespedes followed up on Pluvicto, asking about the main pushbacks from centers not using the drug at its target rate. He also asked a broader question about the Inflation Reduction Act (IRA), specifically the outlook for changing the exclusivity period for small molecules from 9 to 13 years.

Answer

CEO Vasant Narasimhan identified key challenges for Pluvicto adoption as reimbursement processes, staffing needs, and referral network operations, which he described as surmountable. Regarding the IRA, he expressed cautious optimism, noting bipartisan support and the President's backing for extending small molecule exclusivity to 13 years, calling it a top industry priority.

Florent Cespedes asked about the 2025 guidance, specifically how Novartis will offset margin pressure from the Entresto LOE, and later inquired which 2025 pivotal Phase III readouts are most meaningful now that pelacarsen is delayed.

Answer

CFO Harry Kirsch addressed the guidance, explaining that strong top-line growth and SG&A leverage would offset margin pressure. Later, CEO Vasant Narasimhan highlighted key 2025 readouts, including Ianalumab (Sjogren's, ITP), Pluvicto (hormone-sensitive prostate cancer), and Remibrutinib (food allergy), as critical catalysts for future growth.

Florent Cespedes from Bernstein asked for more color on the market opportunity for Cosentyx in hidradenitis suppurativa (HS), considering its potential to attract new patients and the impact of future competition.

Answer

CEO Vasant Narasimhan stated that the HS market has significant room for expansion as new, effective treatments like Cosentyx become available, increasing diagnosis and treatment rates. He reiterated the company's belief that Cosentyx in HS will become a $1 billion medicine, expressing optimism even with future competitors due to the large unmet need. He also noted a pipeline of future agents for HS is in development.

Florent Cespedes asked about Sanofi's M&A strategy, specifically if more aggressive product acquisitions like Blueprint-like transactions are expected given Dupixent's success and the mixed pipeline. He also inquired about trends in flu vaccines, particularly vaccine fatigue.

Answer

François-Xavier Roger (CFO) stated that M&A is about finding relevant acquisitions, not aggressiveness, with balance sheet capacity for EUR 14-15B while retaining an AA rating, focusing on strategic fit, scientific differentiation, and financial return. Thomas Triomphe (Head of Vaccines) noted early signs of a soft flu vaccination rate in the U.S. for Q3, attributing overall Q3 flu performance to a price decrease in Germany and the soft U.S. rate, while highlighting strong market share and R&D progress in flu vaccines.

Florent Cespedes asked if Sanofi plans to be more aggressive in M&A, particularly for product acquisitions similar to Blueprint Medicines, given Dupixent's success and a mixed pipeline. He also asked Head of Vaccines Thomas Triomphe about flu vaccination trends, considering observed vaccine fatigue.

Answer

CFO François-Xavier Roger stated that M&A focuses on relevant acquisitions that meet strategic fit, scientific differentiation, and financial return criteria, rather than aggressiveness, noting Sanofi's capacity to invest €14-15 billion while maintaining its AA rating. Head of Vaccines Thomas Triomphe acknowledged early signs of soft flu vaccination rates in Q4, particularly in the U.S., and noted Q3 performance was impacted by price decreases in Germany and lower U.S. vaccination rates. He highlighted strong market share and R&D progress in flu vaccines.

Florent Cespedes from Bernstein asked for details on the Dupixent launch ramp-up in COPD and questioned if Sanofi's M&A strategy would return to smaller, early-stage assets following the larger Blueprint acquisition.

Answer

EVP & Head of Specialty Care Brian Foard described the COPD launch as positive, with strong uptake from pulmonologists familiar with Dupixent. CEO Paul Hudson confirmed that while Blueprint was a unique opportunity, the company's M&A focus remains on early-stage assets in the €2-5 billion range to build the future pipeline and maintain its credit rating.

Florent Cespedes of AllianceBernstein asked for the estimated percentage of the severe asthma population most responsive to amlitelimab and for color on the financial impact of the Medicare Part D redesign in Q1.

Answer

CEO Paul Hudson declined to specify the asthma subpopulation size, stating more detail would come with Phase III. Brian Foard (EVP, Head of Global Hub, US General Medicines) discussed the Medicare Part D redesign, noting an anticipated impact from covering the coverage gap but also seeing early positive signs from the new $2,000 out-of-pocket cap, which could increase patient access.

Florent Cespedes of Societe Generale inquired about how the R&D budget will be managed with a growing list of Phase II products and asked for more details on the RSV vaccine for toddlers.

Answer

CFO François-Xavier Roger stated that R&D spending will see a moderate increase in 2025, following a significant EUR 900 million increase in 2024, and that the budget is comfortable. Executive Thomas Triomphe explained the RSV toddler vaccine is a key part of building an RSV franchise, complementing Beyfortus by providing second-season protection with an intranasal product targeting mucosal immunity.

Florent Cespedes inquired about the Beyfortus manufacturing capacity for 2025, assuming the two new lines are approved. He also asked which Phase II projects with readouts by the end of next year are considered the most important.

Answer

Thomas Triomphe, EVP of Vaccines, stated that with the new lines, they should be in a position to meet demand for Beyfortus in 2025, though demand will need to be built over time. Houman Ashrafian, EVP and Head of R&D, declined to pick a favorite Phase II asset but highlighted a broad range of exciting readouts, including rilzabrutinib in wAHA, the TL1A product, the IRAK4 inhibitor, and an alpha-1 antitrypsin fusion protein, demonstrating activity across all core franchises.