Sanofi SA Q1 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Richard Vosser - JPMorgan - Analyst : It certainly is. I'll be very quick as well. I think I've got it to work, hopefully. So a couple of questions, please. Firstly, maybe one just on the amlitelimab asthma data. Obviously, efficacy in these type 2 low patients, just thinking more deeply, how you think that efficacy compares to Dupi and really how you think that will read to the efficacy in AD relative to Dupixent from what you can see. And then a second question just on this novel combination, which I think I heard was with incretins and you're all anti-TNF. Just thinking through that combination, should we be thinking about that in HS? Obviously, there's a disease overlap with obesity there. Struggling to think beyond that in terms of the combined ability, so just thoughts on how we should think about that combination that you're thinking there. Thanks very much. Houman Ashrafian - Sanofi SA - Executive Vice President, Head of Research and Development, Member of the Executive Committee Thanks, Richard. Three little sneaky questions dropped in there and I'll address all three very quickly. Firstly, on amli in asthma, let me start by saying that, as we said at the top of this call, we remain hugely committed to Dupixent with our partner Regeneron. And we will continue driving that in pulmonology, both in asthma, in CRS with NP, et cetera, and of course, in (inaudible) So I absolutely would not take a comparison between amli and dupilumab. Let me answer your question, though, promptly. We're very excited by the results we've seen with amli in asthma. We've been very clear and cautious that it missed its primary endpoint. But I have to say from where I'm sitting and when you see the data, I feel that in multiple subgroups, we have really very compelling data, which has driven our commitment to going straight to Phase 3 in subgroups with substantial medical need. You talked about the higher xenophil group and, indeed, the heterogenous inflammation group. And in those populations, amlitelimab has a distinct place for the treatment of patients, both because of the efficacy in those groups, but also its Q12 dosing. So I hope that answers your first question. The second question was related to balinatunfib and combination therapies. As I said very clearly, actually, we said this early on, there would be a small number of indications in which we would go with monotherapy. But we always plan to combine this in combination. Indeed, even in

Question: Richard Vosser - JPMorgan - Analyst : Thank you.

Question: Luisa Hector - Berenberg - Analyst : Thank you. Thanks for the call. My question is still on amlitelimab and asthma, but maybe to go a little bit more broadly because you have other assets in development for asthma. So how do you see it, more broadly, a respiratory franchise developing within your pipeline, et cetera? And then perhaps I could just check on on Dupixent again, respiratory. So a little bit more color on that COPD launch reimbursement status of COPD and how we should think about that phasing through 2025. Thank you.

Question: Emily Field - Barclays - Analyst : Hi. Thanks, and sorry for the mix up before. Anyways, okay. So on Beyfortus, I was just wondering if you could help us kind of understand -- quantify the phasing impact. Is there any incentivizing for stocking out of a potential competitor launch? And then, in the slides, you also mentioned that you're focusing on increasing the next season immunization rate, particularly in the US. What was the penetration of Beyfortus over last season and how far do you see yourselves being able to take that up this year? And then a question on brivekimig. I was just wondering if you could give us a little more color on the synergistic component of the MOA, given that we know the TNFs alone look inferior to the IL-17s, and then the OX40 ligand, your own monotherapy, didn't succeed. So I was just sort of curious why you think that the combination there will look better than each on its own. Thank you.

Question: Ben Jackson - Jefferies LLC - Analyst : Hi. Thank you. Just two quick ones for me today. First, just a little bit more on the OX40L TNF approach. With the results that you've seen in HS, does this bridge any kind of confidence that there are additional indications that this combination could be useful for? And does that change the relative positioning that you're thinking about with regards to the broader portfolio? Obviously, we've just mentioned the OX40L standalone there and potentially seeing a synergistic effect. But just has this changed how you view any other assets in your portfolio? And then secondly, just on the TNFR1 as well, with regards to the psoriasis readout, has the data that you've seen changed any expectations for the rheumatoid arthritis readout coming up? And then with regards to the combo strategy, I appreciate that you've said that the monotherapy was only a small part of the actual opportunity that you were seeing in the first place. But perhaps could you provide a little bit more color around that and what you see the biggest potential there is for? Thank you.

Question: Peter Verdult - BNP Paribas Exane - Analyst : Hi there. How are you doing? It's Pete here from BNP Exane. Just two questions. I'm surprised this one hasn't been asked yet already, Paul. The letter you and Vas penned in the FT does make valid and fair points. But we know governments have big commitments to defense spending increases and not an unlimited budget. So the simple question for me is, have you had any recent interactions with European politicians that give you hope? Or should we remain cynical about their appetite to better reward innovation in Europe? And then, Houman, sorry, just to sort of labor the point. I know you can't talk about the data, but HS is a big focus for everyone. You know why. So when you are expressing excitement for brivekimig, when we finally see that Phase 2 data, we're all going to do cross-trial comparisons to the IL-17. So I just want to be clear. Are you saying that you feel the data is competitive to the data sets we've seen from the IL-17As and ANFs? Thank you.

Question: Jo Walton - UBS - Analyst : Thank you. I've got one, I guess, slightly philosophical question about R&D and then one about situation in the US. So the philosophical one is, we've seen a couple of what looked like failed results, or at least not particularly good results, which have been blamed on very small sizes of studies. So we can't get to increase our probabilities of success until perhaps the studies are bigger. Are there any other of your Phase 2 studies that are coming out that we may also find just perhaps a little bit too small to give us the answer that we want? And I'm thinking, the OX40 ligand, the data wasn't statistically significant, but you're very convinced it's going to be competitive with Bimzelx, for example, in HS, but we can't see that data yet. And the oral TNF, that also seems to be too small a study to be really very clear about it. Could you perhaps tell us whether you think there is still a decent chance of an oral-only indication for something like RA or whether this is really going to always now be perceived as a combination product? And my second question is just in the US. Paul, I'm asking you this as your role in pharma more than from a Sanofi perspective. But if you do get the opportunity to renegotiate the IRA and go from 9 to 13 years for everything, which everybody thinks is -- appears to be what Trump is encouraging Congress to do. Do you think there will be a significant pay away that you will have to give in exchange for that, because clearly the CBO would say, well, that's going to cost us much more money. So should we see that still as a net benefit for the industry? Many thanks.

Question: Graham Parry - BofA Global Research (UK) - Analyst : Hi. So just wanted to go back to the question on tariffs and just sort of push Francois-Xavier a little bit on that. So based on the administration comments, they have talked about 25% pharma tariffs. It's obviously going through Section 232. And there's a lot of discussion around whether that goes on to transfer prices into the US. So perhaps you could just help us by, if that's the most likely scenario, what sort of impact could that have on Sanofi, a 25% tariff on transfer prices into the US? How easily could you mitigate that, either with prices at one end or with just lowering transfer prices? And would that materially impact on Sanofi tax rate? And also perhaps on Dupixent, just help us understand where the US supply is coming from. Is it all Regeneron, Ireland and US plants? Or is there a Sanofi impact from Sanofi's European plants as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 24, 2025 / 11:00AM, SASY.PA - Q1 2025 Sanofi SA Earnings Call And then just following up on the brivekimig question around being competitive, when you say competitive with existing assets, do you mean it's sort of saying ballpark? Or are you looking for something here that is better than what's there already? Thank you.

Question: James Quigley - Goldman Sachs International - Analyst : Excellent. Thank you for taking my questions. I've got two, please. So first, on amlitelimab and asthma, apologies if I may have missed that, but you've highlighted your confidence in moving to Phase 3, given the potential benefits demonstrated. But would you be able to share if you're planning to move into Phase 3 with the broad population, or a selected population, or multiple Phase 3s across different populations? It would be good to get your thoughts there. And how quickly do you expect to move here? And what could be the next steps since we're starting the Phase 3? And secondly, on the gross margin, the impact was pretty strong this quarter, with COGS declining slightly year on year versus the increase in revenue. So could you give us a little bit more color over the drivers of the gross margin? To what extent is this partly driven by some of the benefits from the new Dupixent manufacturing process? And how would you expect the gross margin to progress through the rest of '25 and into '26? Thank you.

Question: Florent Cespedes - Bernstein - Analyst : Good afternoon. Florent Cespedes from Bernstein. So two quick questions, please. First, I would like to come back on amlitelimab. Could you maybe give a little bit more color on the percentage of the population with severe asthma that should respond the most to the product? You highlighted the higher xenophil or neutrophil. What percentage of severe asthma population these people represent? And my second question is on Medicare Part D redesign. It was supposed to impact most likely more heavily the first quarter and then the impact should ease during the course of the year. Could you maybe elaborate a bit and give some color on the impact from this measure on your accounts? Thank you.

Question: Sarita Kapila - Morgan Stanley - Analyst : Hello. Hi. Thank you for taking my questions. Just a quick one on your US flu vaccine dynamics. I think you called out softer demand and intensifying pricing pressure. So is this baked into your guidance for this year? And consensus is factoring 3% sales growth for flu this year. Should we be thinking about '25 as another year of potentially low single-digit declines? And then taking a step back on AD, you have multiple modalities, OX40, IRAK, also bispecifics with lunsekimig. Some of your peers, Pfizer and J&J, are pursuing trispecifics. So it'd be interesting to get your thoughts here. Is this something you also plan to do? And any thoughts on trispecifics and AD would be interesting. Thank you.

Question: Simon Baker - Redburn Atlantic - Analyst : Thank you for taking my question at the end. Most of them have been picked off, so I can be pretty quick. Firstly, just going back to brivekimig, you gave us the P-value, Houman. I just wonder, given its Bayesian study, if you could give us the posterior probability in that study. And then moving back to the oral TNF and thinking about the internal combination candidates, the IRAK4 degrader springs to mind. Are there any others that we should be thinking about that you may well combine the oral TNF with? Thanks so much.