Sanofi SA Q3 2024 Earnings Call Transcript

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

Question: Richard Vosser - J.P. Morgan - Analyst : Hopefully you can hear me. It's Richard Vosser from J.P. Morgan. Two questions, please. First question on Beyfortus. How are you thinking about the commercial potential beyond this season following the ACIP meeting discussing the Merck Clesrovimab, I can never say data this year. Just to continue with that. And the second question is just on the Opella deal. How should we think about the high single-digit billion proceeds? How much of that would be realized by debt pass-through from a pass down to Opella.

Question: Emily Field - Barclays - Analyst : Hi, Emily Field from Barclays. Thanks for taking my question. I'll ask two. First one on Dupixent. I was just wondering, I know it's very early days for the launch in COPD. If you could give us any sort of early metrics about how you're seeing that launch and this new indication and just how you're thinking about the softness of the launch curve now that you're out there in the field. And then that was a very helpful answer on use of proceeds for Opella, but I just wanted to see if I could get perhaps a little bit more color just because one of the questions that we've been getting frequently this week is with regards to just how much of the dilution from the sale of Opella could be offset with a share purchase. So I was just wondering if perhaps you could provide any more specific comments on that point, that would be very helpful. Thank you.

Question: Graham Parry - Bank of America - Analyst : Great. Thanks for taking my questions. So, firstly, on Beyfortus just wondered of the EUR1.5 billion guidance that you're pointing to for the year now, just which countries are assumed in that? And roughly what sort of penetration do you target in key markets such as US, France, Germany and are there any more markets to come still that that are not mentioned in the press release today? And then secondly, on buybacks and just could you remind us of your current buyback authority that you have from the board and how much of that is left to execute an independence of Opella or any cash receipts there? Is there anything that stops Sanofi from executing a buyback today or before Q2 next year, for example? Thank you.

Question: Seamus Fernandez - Guggenheim Securities - Analyst : Thanks for the question. So just a couple. First on your strategy with amlitelimab. Just wanted to get a better sense of the importance of asthma in that data set. And then also how you're deciding to move forward with your OX40 TNF given the data that are coming roughly around a similar time frame for that by specific antibody. And then incremental to some of the questions that have been asked. Just wanted to get a better sense of your commitment to the strong growth recovery that you've talked about in the past, I think now the consensus expectation is for anywhere from 15% to 18% growth year over year. And REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 25, 2024 / 12:00PM, SASY.PA - Q3 2024 Sanofi SA Earnings Call it seems like there's a potential acceleration in the overall biopharma business that could be coming with the removal of Opella from the base business. So just wanted to get a better sense of how we're thinking about the year-over-year growth expectation and opportunity there. Thanks so much.

Question: Jo Walton - UBS - Analyst : Thank you. Just to clarify to confirm that when you present your full year '24 numbers, they will be on the new basis. So we won't be at least on the headline basis, seeing the sales of Opella and all the earnings through, that will all be just a single disconntinued line item that won't be in your business EPS.

Question: Jo Walton - UBS - Analyst : Excellent. And the other clarification, if you could give us any help on the tax rate that might be expected in FY25 just given the comments about potential higher tax in France, if you could just give us a sense of what that might do. But my main question is, please, any help you can give us on negotiations for IRA for next year in the US. Other companies have said that the loss of rebates, particularly in immunology because of the loss of the Humira rebates has made PBMs particularly hard in their negotiations for 2025 for rebates. And of course, we note that Dupixent gets the first sort of proper competitor with EBGLYSS from a major player that can also give heavy rebates for next year. So I wonder if you could talk a little bit about that, please.

Question: Peter Welford - Jefferies - Analyst : One, first of all, coming back to the 2025. I wonder if you could provide perhaps a little bit more help for us on a few items that would help perhaps narrow the range a bit for consensus. Firstly, is there any potential stranded costs that we should think about from the Opella in 2025 that will then become freed in perhaps in 2026. And also, just you made the comment on the sales and marketing that you've brought forward some of the investments to support the launches, how should we think about that perhaps going into 2025? And then the second question is on Phase 3 trials for new vaccines and I guess the question here is, first of all, with the Novavax and the deal you've done for the combination flu, would your intention be to run an efficacy study as you talked about for that. And similarly, there's an FDA VRBPAC meeting, I think, the meeting has been called on the December 12 to discuss pediatric RSV. Curious if you've been asked to participate in that because as far as I'm aware, you're the only Phase 3 pediatric RSV vaccine currently that is in the clinic. Thank you.

Question: Luisa Hector - Berenberg - Analyst : The first one for Thomas, just to continue on the flu franchise. How soon do you expect a COVID flu with an ACIP recommendation to be on the market? And then second question is for Paul, five years, well done. So you've made enormous progress transforming the Sanofi business, but looking forward, R&D is the outstanding challenge. So what or when do you see as the most critical inflection points for determining progress in the R&D transformation and how is the organization positioned to really maximize on pipeline successes, but as Houman mentioned, the inevitable failures that come with the territory. So essentially, is the pipeline big enough? And is the spend both internal and external sufficient? Thank you.

Question: Thibault Boutherin - Morgan Stanley - Analyst : Just a couple of questions on radioligands. You in-licensed projects for GETNet. There is already a GETNet indication. So just wonder if you could comment on the positioning versus the standard of care and what you think you can achieve here? And second question still related to radioligands if you could comment more broadly on your ambitions here. You also invested in a joint venture with Orano Med. So if you could comment on is this kind of a one-off because you saw something specific here? Or is it a way for Sanofi maybe be REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 25, 2024 / 12:00PM, SASY.PA - Q3 2024 Sanofi SA Earnings Call more present in the oncology space in a targeted way? And also, if you could comment on anything regarding the supply chain for this, how it stand between you and your partner and your ambition on the space. Thank you.

Question: Simon Baker - Redburn Atlantic - Analyst : Two if I may, please. Firstly, on Beyfortus. Could you just remind us where we currently or where you currently are with capacity and how that will evolve in '25 and '26. And then the second question, going back to Opella, I wanted to ask about the influence that BPI France will have, specifically, any influence they have beyond the one board seat.

Question: Steve Scala - TD Cowen - Analyst : Does Sanofi have any efficacy data for Beyfortus, which supports protection through six months and what percent of RSV cases fall between five and six months. This would appear to be one advantage that Merck may indeed have. And then second, is Sanofi on track to initiate Phase 3 trials for its 21 valent pneumococcal vaccine this year? And is it still commercially viable given the competitor's 31 valent data?

Question: David Risinger - Leerink Partners - Analyst : So congrats on the financial results. I have two questions. First, regarding Amgen's OX40 Phase 3 efficacy, since it was lower than expected, did the weak efficacy results impact your expectations for forthcoming amlitelimab efficacy? And then sorry about the noise. Second, Sanofi has several I&I pipeline readouts over the next year. Could you please provide a framework on how the company plans to disclose the slew of results that are coming, including four Phase 2 data readouts, which will be important proof of concepts? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 25, 2024 / 12:00PM, SASY.PA - Q3 2024 Sanofi SA Earnings Call

Question: Richard Parkes - BNP Paribas Exane - Analyst : Hi. Thanks very much for taking my questions. Just coming back to Beyfortus and expectations into 2025, I wondered if we could just push you a little bit more on that. If in the worst case competition does materialize just wondering whether you would be willing to commit to still being able to grow the franchise even with or without competition, maybe through international launches? And then related to that, I think, at the Vaccine Day a couple of years ago, you put a slide implying RSV infant market forecast of [2.4 billion] by 2030.I'm sure your thinking has evolved since then. So could you just update us on your current thinking over the total commercial potential? Thank you.

Question: Rajesh Kumar - HSBC - Analyst : Another one on Beyfortus versus Clesrovimab. When one of the points which Merck are making is the stocking up is much easier if the dose is body weight not dependent on the body weight. So how do you help the providers with stocking up of inventory for different body weight infants and how can you ensure that doesn't become a significant disadvantage for you? Obviously, efficacy and all the data points you've made are well-noted. So -- but this aspect of practical ordering might be helpful to understand. And just a clarification on Opella, can you just run through in terms of the cash proceeds you've guided to that's after tax or before tax? Thank you.

Question: Eric Le Berrigaud - Stifel Financial Corp. - Analyst : First, in recent interactions with investors, it looks like there's a topic that comes through more often around Dupixent LOE extension. I'm unclear whether it comes from you, from your partner or from any other source, but maybe you can update us on where you stand about extending LOE of Dupixent? And the second question, maybe I missed it, but I don't see any update into your pipeline agenda about the anti-TL1A. Do you expect this to come from Teva or what can you -- when can we expect some Phase 2 update on that specific assets? Thank you.

Question: Florent Cespedes - Bernstein - Analyst : Good afternoon. Florent Cespedes from Bernstein. Two quick questions, please. First, for Houman on hidradenitis suppurativa. In fact, next year, first half, you will have three Phase 2 trials readout on this -- for this indication with three different mechanism of action. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 25, 2024 / 12:00PM, SASY.PA - Q3 2024 Sanofi SA Earnings Call I was just wondering if you could give us a little bit more color on your strategy on this population as you have already products on the market are quite successful. So some thoughts on this would be great and notably also in terms of potential of this market? And my second question is for Thomas. It's a follow-up on Beyfortus. I was just wondering if we could have a little bit more color about manufacturing capacities for 2025. Is there a third manufacturing line that will be ready next year? And when you mentioned, Thomas, that there will be growth in 2025, I was just wondering if you could give us a little bit more color on this [if you can quantify this]. Many thanks.