SANOFI earnings calls

Dupixent demand and pricing seasonality

Q (Matthew Weston · UBS): Is there risk of major formulary changes or net price moves next year given EBGLYSS DTC, and will Dupixent show the usual Q1 gross-to-net step-down in 2027? Also, is the registrational-enabling term for the long-acting anti-IL-13 a phase III?

A: Management said DTC by competitors increases awareness and helps grow the overall advanced-therapy market, which benefits Dupixent as the market leader. They expect demand growth to continue in 2027 and that we will likely see the same Q1 adjustment seasonality in the U.S. Paulo said phase I for the long-acting anti-IL-13 has started and, if phase I data remain positive, they will accelerate toward phase III.

"You will likely see the same Q1 adjustment that we see in the U.S. every single year, but again, demand growth will continue to stay strong also in 2027." — Manuela Buxo

M&A capacity and frexalimab trial changes

Q (Luisa Hector · Berenberg): What capacity do you have now for deals after the Regeneron payments, and how is your M&A approach different? Also, what was the optimization to the frexalimab Phase III trials and are other trials optimized similarly?

A: Belén said the company is focused on later-stage commercial assets and will stay disciplined on strategic, scientific and financial fit. François would not give an amount and emphasized strategic intent and retaining a strong rating; they may do various deal sizes. Paulo said the frexalimab Phase III trials remain fully enrolled and they prolonged the observational period to collect sufficient events to power the statistical analysis.

"So, as part of what we have started since I came in, which is very thorough technical review process of all of these studies, we continuously monitor how the trials are performing." — Paulo Fontoura

Strategy event and 2027 margins

Q (Sachin Jain · BofA): Will the strategy event by year-end include M&A detail, and should we expect margin guidance changes into 2027 given strong cost control? Also, any view on AMVUTTRA royalty outlook after Alnylam news?

A: Belén said the event will give clarity on focus disease areas, mitigating Dupixent LOE, R&D turnaround, and capital allocation including BD/M&A, with more color to come. François said Q3 showed strong cost control and profitable growth; it's too early to guide 2027 but expect cost base to grow less than sales and they will increase BOI in absolute value and margin each year to 2030. On AMVUTTRA, François said they see no impact for 2026 and will assess 2027 implications after reviewing market consensus.

"It's too early to give some guidance on 2027, and this is not the right time to do it." — François Roger (CFO)

OPEX outlook and R&D sourcing

Q (Michael Leuchten · Jefferies): When you say OPEX will grow below sales for 2027-2028, is that purely organic or does it assume bolt-on M&A? And how will you get assets into the organization to allow faster R&D execution?

A: François said the 2027 view is based on organic growth plus traditional bolt-on acquisitions; larger M&A would be incremental and they can't reflect it until announced. Paulo said his focus spans the whole R&D value chain, not just research; they will maximize internal assets, pursue collaborations and BD/M&A as needed, and incorporate AI to increase research funnel and speed execution.

"My focus is not only on research. My focus is across the whole R&D value chain, and research is definitely very much a part of that." — Paulo Fontoura

R&D spend and Dupixent growth outlook

Q (Richard Vosser · JPMorgan): Should we expect R&D spend to fall in 2027 given less late-stage work, and will Dupixent growth be mainly volume with some price decline next year?

A: Paulo said Sanofi already invests significantly in R&D and does not expect overall spend to change much next year; the focus will shift toward earlier-stage research and AI, and investment may rise for new molecules from collaborations. Manuela said demand growth for Dupixent will continue but percentage growth will moderate as the base becomes larger; the company remains confident in reaching EUR 25 billion by 2030.

"Sanofi already has a very significant investment in R&D. We do not expect it to really change much in the next year." — Paulo Fontoura

R&D culture, talent, and Dupixent upside

Q (Peter Verdult · BNP Paribas Exane): How will you improve R&D culture and scientific rigor, including organization and talent, and what could push Dupixent beyond EUR 25 billion or affect 340B litigation outcomes?

A: Paulo described introducing a formal scientific review process and new governance to institutionalize technical review, creating end-to-end therapeutic area ownership and attracting diverse talent including AI skills. François said they are conservative and stick to the EUR 25 billion guidance but will work to exceed it; Jamie said 340B litigation is dynamic and they have a robust program but cannot predict legal outcomes.

"What I mean by changing the culture in R&D to have more scientific rigor, part of it is obviously, let's say, intangible." — Paulo Fontoura

Dupixent US volume drivers and 340B scrubbing

Q (David Risinger · Leerink): For Dupixent in 2027 in the U.S., what are the volume growth pushes and pulls? And what have you accomplished so far on 340B scrubbing and is more upside available?

A: Manuela said Dupixent leads across specialties and they are confident in continued volume growth across all nine indications and geographies, but percentage growth will moderate because the treatment base exceeds 1.5 million patients and new competitors may affect growth. On 340B scrubbing, they have made operational improvements and will continue optimizing gross-to-net, but do not expect ongoing large incremental gains from that base.

"Of course, when you're thinking about the base that we now have, more than 1.5 million patients on treatment, the growth as a percentage of that base is going to slightly moderate, and that's what we're highlighting." — Manuela Buxo

Closing R&D productivity gap and China plans

Q (James Quigley · Goldman Sachs): What will close Sanofi's pipeline productivity and size gap, how will AI help, and how easy will it be to hire and build R&D in China and what will you do there faster or differently?

A: Paulo said they need more volume of good molecules and faster decision-making; they revamped governance, use AI-assisted tools, and will partner externally to improve productivity. On China, he said it's early days but they aim to access the local ecosystem and build a strong on-the-ground presence to leverage technology and translational speed.

"The fact that we're going to start focusing more on certain key areas allows us to go deeper and broader in those areas as well, instead of dispersing our efforts much more broadly." — Paulo Fontoura

China commercial and manufacturing footprint

Q (Thomas Triomphe): Following the China discussion, how does existing commercial and manufacturing scale support R&D expansion there?

A: Management noted they already have a strong commercial presence with more than EUR 2.5 billion sales in China, a growing manufacturing footprint including an insulin facility, and they plan to expand R&D capabilities both internally and via partnerships to access the local ecosystem.

Regeneron JV flexibility and China strengths

Q (Florent Cespedes · Oddo BHF): If you acquire an on-market inflammation product, could you add it to the Regeneron JV? And which areas in China are local companies stronger in that interest you?

A: Belén said the Regeneron alliance gives flexibility to opt into deals together or to pursue deals independently depending on partner interest. Paulo said China shows strong progress in rapid chemical-matter generation and translational speed to generate proof-of-concept data quickly, which Sanofi wants to leverage.

"So, the current approach, as I mentioned, is a win-win, is giving us either Regeneron or Sanofi tremendous flexibility to opt in to the alliance or to go independently if we believe this is better for the individual partners." — Belén Garijo (CEO)

Gross-to-net one-offs and M&A focus

Q (Graham Parry · Citi): Can you quantify gross-to-net benefits in euro terms and how much of Dupixent's growth was one-off versus sustainable? Also, which therapeutic areas will you prioritize for M&A?

A: François said underlying group growth excluding one-offs was 12% versus reported 14%, so 85%-90% of growth is recurring and demand-driven. Manuela added script data may understate demand due to patient mix and operational improvements helped gross-to-net, with one-offs small. Belén said M&A focus will be immunology, rare diseases, and vaccines, with further detail to come in December.

"between 85% and 90% of our growth is recurring, demand-driven, sustainable growth, and is not linked to one-off." — François Roger (CFO)

Why Dupixent LOE impact is moderate

Q (Thibault Boutherin · Morgan Stanley): What gives you confidence that group top-line will be only moderately impacted by Dupixent loss of exclusivity — the Regeneron transition, execution on pipeline, or BD/M&A?

A: Belén said their priority is revenue growth post-2031 and they expect only a moderate group revenue impact from Dupixent LOE; they will focus first on preserving earnings and cash flow, and because of the alliance profit split the earnings hit is smaller than the revenue hit. More roadmap detail will be provided in December.

"Above all, we aim to preserve our cash flow." — Belén Garijo (CEO)

Most exciting pipeline assets and focus effects

Q (James Gordon · Barclays): Beyond the Regeneron assets, which internal pipeline assets are you most excited about, and does therapeutic focus mean you will pursue divestments of non-core businesses?

A: Paulo highlighted efdoralprin alfa, frexalimab, lunsekimig with COPD potential, and duvakitug as exciting programs with strong clinical potential and regulatory interest; he said they need more assets and will increase pipeline via internal work and BD/M&A. Belén said most capital will go to immunology, rare and vaccines, and non-focus areas could be out-licensed, partnered, or closed depending on strategic fit.

"This is a very exciting program. It addresses a real medical need in the population that up until now has really poor standard of care, and it could be both best in disease in terms of convenience, but also in terms of efficacy." — Paulo Fontoura

Data-driven gross-to-net impact now and going forward

Q (Simon Baker · Redburn): Have you seen the full impact of data-driven gross-to-net management, and should we expect only a smaller gap between volume and sales going forward or more to come?

A: François said they improved gross-to-net control using data management and AI, which improved accruals and provisions and produced a one-off exceptional benefit in Q3 that he does not expect to repeat at the same scale; traditional Q1 reversals will still occur. He therefore does not expect much more one-off upside beyond the recent improvement.

"With these tools, we have improved tremendously our knowledge, and that allows us to improve the accrual level and the provision level that we do for gross-to-net." — François Roger (CFO)