Sanofi

Hello everyone, this is Thomas Gusslaten from the Zenufi IR team. Welcome to the Q2 2025 conference call for investors and analysts. As usual, you can find the slides on zenufi.com. Please turn to slide number 3. Here we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements, which are subject to substantial risk and uncertainties that may cause active results of different material. We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our Form 20F on File with the US SEC and our French Universal Registration Document for a description of these risk factors. As usual, we will be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are in millions of euros and for Q2 2025, unless stated otherwise. Please turn to slide number four. First, we have a presentation, then we'll take your questions. We have kept the presentation as short as in the past, as other companies report today, and we aim at keeping the call to maximum one hour, all included. With Q&A, we have Brian, Olivier, Thomas to cover our global businesses, as well as Roy, our general counsel, and Brendan, head of manufacturing and supply. For the Q&A, you have two options in Zoom. Raise your hand or submit your question using the Q&A function. With this, I'll hand you over to Paul.

Well, thank you and hello everyone on the call. We delivered another strong quarter with double digit sales growth. Our strategic focus on innovation continues to drive our top line performance with significant contributions from our new launches, vaccines and duplexes. The performance of our growth drivers made us more confident in our full year business outlook. With that, we've refined our 2025 sales guidance to high single digit percentage sales growth at constant exchange rates. Let me highlight the performance of our new launches on slide six. In Q2, our launches generated close to €1 billion in sales, continuing the momentum we saw in Q1. Altubio extended its strong performance, increasing market share through patient switches. The presence of Bay Fortis in Southern Hemisphere countries was further expanded in Q2. Keep in mind these are smaller markets compared to our key launch countries in the Northern Hemisphere. Qfibia, following the FDA approval at the end of Q1, has recorded initial sales. Uptake has been as expected, and we're pleased to be able to offer an additional treatment option to healthcare professionals and patients living with haemophilia A or B. Together, these nine launches now represent 10% of our total sales, demonstrating our successful execution in bringing innovative medicines and vaccines to patients. DuPixen sales reached €3.8 billion, up 21% in Q2, driven by the continued strong demand and approved indications across geographies. Momentum has been driven by market growth across all indications, where biopenetration remains low, as well as by recent launches, including COPD. In the US, sales reached €2.8 billion, up 22.7%, as Dupixent continues to lead in both new-to-brand prescriptions and total prescriptions across all established indications. The CSU launch is off to a promising start, supported by positive feedback from physicians and patients, and broader payer coverage in the first two months. Outside the US, sales again exceeded the €1 billion mark, driven by volume growth in key markets. Eight years after its initial launch in atopic dermatitis, Dupixim continues to demonstrate strong and sustained growth, with bolus femfigoid being its eighth indication approved in the US. Our ongoing efforts in deepening biologic penetration and expanding indications support our ambition of reaching sales of approximately €22 billion in 2030, in line with previous communications at Q4. Our vaccine business delivered solid growth in Q2, with sales increasing by 10.3%, driven by the Bay Fortis expansion that I just mentioned, and benefiting from the effect of the late 2024-2025 flu season in the Northern Hemisphere. As a reminder, the larger portion of our vaccine business is in the second half of the year, due to the seasonality of flu and RSV in key markets in the Northern Hemisphere. Francois will provide our indication for 2025 Bay Fortis and flu vaccine sales in just a minute. Our vaccine franchise was further strengthened this quarter by several important R&D and regulatory milestones. A key example is the extended duration of protection for up to six months in the EU label of Bay Fortis. And we continue to invest in the future of vaccines, most recently entering an agreement to acquire Vice Bio. Vice Bio would represent a strong strategic fit with our ambition to develop vaccines that can protect against multiple respiratory pathogens. It would also add an innovative technology for combination vaccines, specifically designed for vulnerable groups such as older adults and those at increased risk of severe RSV and HMPV infections. Moving to slide 9, the completion of the Blueprint medicines acquisition just two weeks ago marked a major milestone in our strategic capital redeployment. Blueprint significantly strengthens our position in rare immunology diseases, particularly with Avakit in systemic mastocytosis, along with a promising pipeline. We are very encouraged by the strong performance of Avakit, reaching US$175 million in sales in Q2, While this performance is not included in the Sanofi Q2 financials, it underscores both the high unmet need and advocates' potential as the first approved medicine in advanced and indolent systemic mastocytosis. The addition of Blueprint brings an established presence amongst allergists, dermatologists, and immunologists, enhancing our ability to advance our own pipeline in immunology. With the acquisition now completed, I would like to formally welcome the talented teams of Blueprint to Sanofi. Together we look forward to the potential of Avakit as one of Sanofi's next blockbusters. Here I'd like to highlight our progress in sustainability leadership. We are proud that Time has again ranked Sanofi as the world's 10th most sustainable company across all industries and number one in pharma and biotech. A good example is the eco-design approach we're taking to reduce the environmental footprint of our medicines and vaccines. By 2025, all new medicines and vaccines will incorporate eco-design principles, extending to our 20 top sellers by 2030. We're already seeing impressive results with Dupixent, Trujillo, and Hexacin through optimized manufacturing, packaging, and production. Thank you. I'll now hand over to Francois, our CFO, for more details on the financials.

Thank you, Paul, and hello to everyone. As highlighted earlier, net sales increased by 10.1% at constant exchange rates in Q2. This growth was primarily driven by immunology, by our pharma launches, and by Befortus. Growth margin improved by 1.5 percentage points, largely led by an improved product mix and efficiencies. R&D expenses increased by 17.7% due to the lower base of comparison last year, with the one-time reimbursement from Sobi. Underlying R&D expenses excluding this reimbursement increased by around 7%. We expect a moderate increase of R&D expenses in H2. Business EPS was 1.59€, up 8.3%, reflecting on strong sales performance and improved gross margin. Let me make a few comments beyond Q2 and discuss H1. SG&A is increasing in H1 at around half of the rate of our sales growth, and 70% of the increase in SG&A goes to sales and marketing investments to support growth that we have and future launches that are coming. Business EPS in the first six months of the year is up 12%, which is fully supporting our expected strong EPS rebound for the full year 2025. Moving to the next slide. In Q2, we continued to execute our capital allocation priorities. After having received in April around 11 billion euros from the sale of a controlling stake in Opella, we have been actively redeploying this capital. Indeed, we have announced the acquisition of DrainzBio DR0201, Vigil Neuroscience, Blueprint, and last week, ViceBio. These acquisitions are perfectly aligned with our strategy and meet our three main expectations. First, strategic fit within our core therapeutic areas. Second, scientific relevance offering differentiated medicines and vaccines. And third, financial attractiveness. Three of our four announced acquisitions reflect our interest in early-stage assets. While Blueprint is at the higher end of our targeted range, we are confident in its strategic value, playing both in rare diseases and immunology areas, and we are confident as well in its future financial returns. As previously indicated, early stage opportunities remain our primary interest. However, we always retain the flexibility to slightly expand beyond our pre-established interest when compelling opportunities arise with attractive business cases. Looking ahead, we retain further capacity for business development on M&A while remaining committed to our AA credit rating. In parallel, we are executing our €5 billion share buyback programme in 2025, with over 80% already completed as of today. We remain firmly committed to completing the full programme by the end of this year. Moving to the next slide, I would like to highlight two key components of our ongoing financial performance, namely the Regeneron Development Balance and the AMVUTRA royalties. First, it is important to note that the profit-sharing payments to Regeneron are increasing in direct correlation with DuPixent profit growth. These payments are partially offset by the development balance compensation we receive from Regeneron. As a reminder, Sanofi has historically funded a larger share of DuPixent development costs compared to our partners. Under the agreement, Regeneron reimburses up to 50% of this cumulative cost by deducting them from our profit-sharing payments. Based on current projections, we anticipate this development balance to be fully reimbursed by the end of 2026. This reimbursement arrangement is expected to result in a negative year-on-year BOI impact for Sanofi of approximately €300 million in 2026, followed by a more substantial negative BOI impact of approximately €800 million in 2027. From 2027 onwards, R&D costs incurred will be shared within the same year. Second, new royalty streams are emerging as an increasingly important margin driver. For example, Amvutra was recently approved for a new indication in both the US and EU, with royalty rates up to 30% of sales. As illustrated on the right-hand side of the slide, the expected royalty revenue of this medicine, based on external consensus, will have a significant contribution to our financial outlook, probably until the end of the decade. Let me now give you a little bit more color on some key considerations for the balance of the year. Beportus had a strong momentum in 2024 with high vaccine coverage rates in many markets. We anticipate modest growth for 2025, with Q4 sales likely to be roughly similar to Q3. For flu, while we anticipate gaining market share, total sales are expected to decrease by a mid-teens percentage versus last year due to competitive forces, in particular in the US and in Germany. We anticipate a sales split of about 75% in Q3 and 25% in Q4. For the full year 2025, operating expenses may increase slightly due to the previously announced acquisitions. Forex impact is now estimated to be around minus 4% on sales and around minus 6% on EPS. Other items are similar to what we shared with you last quarter. For the full year 2025, we are now expecting sales growth at a high single-digit percentage at the upper range of our previous guidance. This refinement of our sales guidance is not linked to Blueprint, which is consolidated by the way from mid-July 2025, but it is linked to the underlying performance of our business. We confirm our EPS guidance of a low double-digit percentage growth at constant exchange rates, This is also an implied upgrade of our EPS guidance, as we now absorb a few hundreds of millions of additional costs from the newly acquired businesses, largely in R&D. Finally, we are navigating through a dynamic world with a lot of uncertainties from potential US tariffs and EU exports. However, as all the details are still limited and not fully settled yet, we will update you along the way. I now hand over to Ouman, who will provide an update on the progress of our innovative pipeline. Thank you, Francois.

Since our last update, we received U.S. approval for dupixin, embolus pentagoid, and men-quadfi six weeks, and last week the EU approval for Sarklesa in newly diagnosed transplant-eligible patients. Furthermore, dupixin was submitted for review in Japan for BP and serozyme in the U.S. for Gaucher disease type 3, with an FDA decision expected in January next year. Despite Itspecimab's mixed Phase 3 results, our pipeline continues to advance with new rabies vaccines showing consistent Phase 3 efficacy. We re-secured seven new regulatory designations, including Orphan and Fast Track, and had seven medicines featured in prestigious journals, which emphasizes our determination to accelerate our commitment in improving R&D. Last quarter, as Francois said, we acquired DR201 from DrenBio, now entering Phase 1 in Immunology. We've since made two acquisitions, Blueprint with Avakit, and two new potential options in mid-stage clinical development, the potential next-generation molecule L-Investamib for mastocytosis, and Blue808 in inflammatory indications, and lastly, Vigil, with VG3927, which has the potential to magnify and restore the neuroprotective function of microglia in Alzheimer's disease. We remain committed to expanding our pipeline with more opportunities, both internally and externally. We're excited about new monoclonal antibodies from multiple myeloma, which was recently designated an awesome drug, showcasing our ongoing innovation from our own research in France. Externally, we continue to augment partnerships and collaborations, working hand-in-hand with other leaders in the field to bring cutting-edge treatment solutions. Next slide. We're committed to addressing the large, unmet medical needs for different COPD patients, with dupixent, with ifopecimab, and lastly with linsecumig. At ATS, we present pooled data from Borealis and Nodis Phase 3 studies, showing significant reductions in exacerbations, FEV1 improvement, and quality of life, confirming our legacy in COPD with depiction. For a Tepecumab targeting former smokers, we're progressing the data analysis for RFI-1 and RFI-T Phase 3 studies, including insights from other molecules targeting the same pathway. And once more advanced, we will discuss with regulatory authorities and provide an update on next steps. The data will be presented at a forthcoming medical meeting. Lastly, we announced our intentions in evaluating lunasecumine, our IL-13 TSLV pentavalent antibody, in a Phase II-III COPD study this year. Based on its benefits seen in existing clinical study, and two known and proven mechanisms of action, we have faith in its dual-targeting nanobody technology with strong advocacy and proof of concept due to its deeper access into lower respiratory tract airways. Phase 1b data showed a 40.9 PPD reduction in phenol levels in asthma with patients at day 29. The medicine remains our main interest in respiratory conditions, thanks to its effect on biomarkers and symptoms. Next slide. Brilzabritinib has emerged as a safe and highly effective platform for rare diseases. The regulatory decision is expected soon for ITP with a target action date for the FDA decision on August 29, 2025. It's received its first global approval recently in the UAE. Moreover, we're pleased by the recent designations received a fast track for IgG4 disease, an orphan drug for Weha, and sickle cell disease all in the U.S., an orphan designation for IgG4 in the EU. To complement our presence in rare diseases, at ASCO we presented the subcutaneous sarcleza data from three studies, evaluating the convertibility of sarcleza administered either by both on-body injector or manual infusions compared to IV results from the study across different lines and regimens, which demonstrated non-inferiority with most of the patients preferring the on-body injector. Regulatory submissions were underway with acceptances expected soon. Finally, F-doropren alpha, our recombinant human AAT1 fusion protein, in a phase 2 superiority study for AAP1 antitrypsin deficiency, aiming for normal functional AAT levels with greater convenience. Data is expected H2 2025. Sanofi is deeply committed to rare diseases. We've established a global franchise with a strong presence in enzyme replacement therapies and hematology, as demonstrated by Altuvio and, lastly, Petuceran. Based on this solid foundation, we're expanding our expertise and our pipeline to address the unmet medical need in patients with rare diseases worldwide. Our global reach, combined with our specialized knowledge, positions us uniquely to make a significant impact in the lives of those affected by rare diseases. Riliprubar, our C1S complement inhibitor for CIDP, which shows promising progress in an area with remaining unmet medical need, despite the availability of existing therapies. At PMS conferences that took place during the second quarter in Edinburgh, Scotland, we presented new long-term extension data from our Phase II study. Part A demonstrated that most patients improved but remained stable on riliprubar at 24 weeks. Results from the Part B confirmed findings across all CIDB patient subgroups, including those who are on standard of care, refractory, or naive, where patients remained relapsed free and sustained their response at week 76. Patients showed 35% reduction in NFL levels and a strong and sustained reduction in complement activity compared to baseline. Reliprobar offers potential and safe, effective subcutaneous option for CIDP, and now also for antibody-mediated rejection, with orphan drug designations in Japan for CIDP and the U.S. for AMR. Our Phase 3 program includes two studies. Mobilize is for patients who have experienced failure or inadequate response to standard care therapies, which are mostly IVIG or steroids, depending on the country, and Vitalize is It's the first head-to-head study for patients who are on IVIG and remain partial responders. Currently, both studies expect data from H2-2026. I would like to conclude with my usual flow slide for the next 18 months, which includes a new view of 2026 split into two halves. Key upcoming studies include the Phase II, CF Doralprin Alpha in AATD, and DOTIME with Oranomed. and two significant phase III readouts with tolibrutinib and PPMS, and the first data for amlitilumab in ADs this year. Next year, we expect the remaining phase III data for amlitilumab in AD, potentially followed by submission. The Q4 dosing in the phase III study is seeking to replicate positive data from the stream AD phase II study with an additional Q12 arm to assess the potential of longer dosing. The Q12 dosing is also used in the extension study. Our objective is to explore a more convenient treatment approach in AD with as few as four injections a year, potentially in the maintenance setting. As a reminder, recent results in asthma provided support, the longer dosing interval potentially possible with OX40 ligand modulation on top of the AD phase 2 data that suggested sustained efficacy after ending treatment. While not all of our efforts will succeed, as is the nature of drug development, we're confident our skill teams and advanced digital technologies will drive progress in our core therapeutic areas. I thank our R&D team and colleagues for their achievements in making me chasing the miracle science to improve the lives of patients. With this, I will hand back to Paul.

We'll now have the call to your questions. As a reminder, we would ask you to limit your questions to one or two. You'll be notified when your line is open to ask your questions. At that time, please make sure you unmute your microphone or option two, submit your question by clicking the Q&A icon at the bottom of the screen. Your question will be read by our panelists. Now we'll take the first question.

Please go ahead. The first question is from Luisa Hector from Verenivale. Luisa?

Hi there. Thank you for the call. So I wanted to touch on the R&D transformation because we see enormous amounts of progress at Sanofi across the whole organization, but the share price is still lagging, and I think it's awaiting pipeline progress. So on the R&D transformation, I wanted to check your levels of confidence given some of your recent successes, but also some more mixed data sets, which are still in-house. And if we go back to your December 23 R&D day where you laid out some objectives, you were targeting a 50% increase in phase three trials for this year, 2025. You highlighted the new launch cohort with risk-adjusted sales over €10 billion in 2030 and your 12 blockbuster assets, of which three of those could be over €5 billion. So I wondered if you could just comment on those specifically. Are you on track for the phase three trials? Are you more confident in your €10 billion by 2030? And if so, has the mix changed now that you have more data in-house? Thank you.

Thank you, Louisa. Very comprehensive. Ahuman, do you want to get started?

Louisa, thanks for the question, and I'll try to remain succinct. Sanity has become an R&D-driven company. We are committed to innovation in the service of patients, and I'm excited by the transformation that takes place. But we have to acknowledge that an R&D transformation is something that doesn't happen overnight. Many in the industry would believe it takes five to seven years, and I'd like to believe that we're a significant way through that. The proof will be in the pudding, and we remain humble in the face of disease. To answer your question specifically and very directly, of the three big ones that you described that we talked about on the 7th of December conference, 2023, amlitilumab was one of the three, as was Frexen, Melanotemfib. We remain committed to all the molecules in our portfolio. Amlitilumab will read out in the relatively near future with its first phase three. We look forward to pressure testing our predictions. I'll stop there and hand over to Paul.

Yeah, I mean, you know, Louisa, and I think it's fair to say we've had plenty of time to reflect on the ups and downs of this year. And while not everything has gone our way, you know, the data sets have allowed us to do some good thinking around how to go forward or not, as the case may be. You know, I think Hooman used the word humble, and I would add to that because I think, you know, this transformation has been moving at such a pace that that we have spent the recent months literally going back and kicking the tires to make sure that we have dotted every I, crossed every T on the studies to make sure that, you know, we will continue to push science, of course, as expected of us. What we would like to avoid is stubbing our own toe. So we have some work to do. I think we remain, on balance, optimistic about the nature of the Big 12 and what that could mean for us. Of course, not everything will work. I'm very pleased with how the transformation has progressed. But I think you're right, by the way, that is, for some, the jury remains out, that the progress is one thing, but it's revealing itself in successful phase threes. And I think I said this, I think maybe it was you that asked me a question for reflection on a previous call. You know, I'd like to think these things could have been done faster, but I've learned a few things about being patient. So we have to do the work, be diligent, be accurate and factual, and then we just have to turn the cards over. And we recognize that we're better just to keep up out of drive, get the results, share them, and confidence will be built from there.

The next question is from Richard Vosser from .

Thanks for taking my question. First question just on development of spend that a little bit higher in the first half on both SG&A and OPEX, obviously ahead of new launches on SG&A. Just how should we think about the development of that? probably also thinking about 26 as well you potentially have some interesting launches maybe at the latter end of that year and in 27 so Should we think SC&A goes up from here, R&D as well? You know, have we reached a level or, you know, with the trials that you're starting, should we expect that and Blueprint to go up as well? And how should we think about the margin in 26? Is that sort of at a similar level of 25? And then just a quick bit on Dupixent, a little bit weak in China maybe, and we've seen that with some products who have NDRL listing in China and some pressure in that market. Just thoughts about China, Dupixent, and the rest of the portfolio and how we should think about the growth there going forward. Thanks very much.

Thanks, Richard. I think, and it's a couple of questions we've had throughout the day or morning, SG&A, R&D spend. Of course, a little bit higher in the quarter, François. Where do you think, how can you guide?

Richard, it's a good question, François speaking. On R&D, obviously, I mean, we reported an increase of 17% in the quarter, but if you put aside the exceptional item, that exceptional revenue that we had from Saudi last year, it's 7% underlying. As I said earlier, we expect to be probably around flat, maybe slightly up in R&D in the latter part of the year. So we will be for the full year where we said we would be, which is slightly up for the full year. There might be a little bit of additional post as well coming from Blueprint, but again, the guidance that we get beginning of the year, we will be there. So there is a little bit of a phasing issue between H1 and H2, we have no concern whatsoever. On SG&E, you can see some increase as well. Just to give you a perspective, I mentioned it earlier, we have a rate of increase of SG&E, which is half of our increase in sales, which means that we are benefiting from gross leverage. Do expect that to continue in the future. And if you look at it, 70% of the increase that we experienced in the first half went to an investment in sales and marketing to get growth, which we have, and to prepare for future launches. So I think it's very healthy because we are in an investment position. Do expect that to continue as well. Just to give you a little bit more color, I don't want to go into a guidance for 26 because it's too early and it's not the right time to do that, but just to give you a direction of travel. We do expect in the next couple of years to enjoy an attractive growth profile till 2031 at least. We will have a tight control on cost, which means basically G&A more or less flat. Sales and marketing up, but probably certainly at a lower level than sales. R&D will be certainly slightly up, although there I want to be very careful. It will depend on readouts, and it may be impacted a little bit as well by some acquisitions in BD and M&A, so we don't have necessarily the full visibility of where we can go year by year at this point in time. But anyway, given that we will get some growth leverage, do expect our BOI to increase year after year in absolute value in the next coming years. Once again, largely as a consequence of an attractive growth profile in sales with a tight control on cost and growth leverage. We'll get that in 2025, and we'll get it in the coming years as well. That will give us space to absorb some specific items, such as the one I mentioned earlier, in the next couple of years, like the Regeneron end of R&D reimbursement, that one we will be able to absorb in BOI, so do expect to see our BOI increasing year after year. And I'm very confident about it.

Thank you, Francois.

I think, and well said, attractive growth profile, tight management on OPEX, R&D broadly flat depending on successes or the opposite in R&D up this year, and we'll see. And we overlay that with being one of the companies with the lowest genomicization profiles over the next five, six, seven, eight years. You know, it's important that we advance the medicines that drive the growth and then fund the launches. But I think we've come a long way as a team reshaping the business. But we have to be extremely prudent with how we deploy those investments because we want increasingly profitable growth. It's just obvious. Brian, do you have anything to add?

Well, thank you, Richard, so much for the question. And I'll come to China in just a second. As you probably know, Dubixen is a pretty diversified product now around the world, a bunch of different indications. We're in eight, as Carl alluded to already, in the United States. And so while China is a very important marketplace, it is one of many where we're actually seeing continued underlying volume growth here. And so I'd first start there. Actually, in China, we've seen more than 30% volume growth in China, so really positive in China right now. Of course, as you mentioned, we will have pricing pressures from time to time in market, as is normally the case and as we plan for, and we will grow through the 100 deal actually eventually. But as we get more access to more indications in China, this is going to be a really important marketplace for us moving forward, but one of many. Okay. Next question, please.

Yes, please. Next question is from Matthew Weston from UBS. Matthew?

Thank you. Two questions for me, please. One is on amlitalimab. And, Human, if I'm a leading AD prescriber, I'd love to know what you think I want to see from amlitalimab. Do I want more efficacy than DUPI? Do I want more efficacy than DUPI in subgroups? Or is it really about looking for the same efficacy as DUPI but with that better duration of treatment? And then just one finance question. The additional comment on tariffs, I think the comment was that there was a lot that was unknown. Have you assumed a thing in guidance for 2025, or have you assumed the basic level that's being discussed in the current EU-US trade deal, or just you've moved so much inventory it doesn't matter this year? Thank you.

Let's start there, Francois. Yes, Mathieu. Anyway, it's difficult to comment on what we don't know, but we have run different scenarios, obviously, and we have, based on what is widely reported in the media, we have looked at the impact that it could have on 2025, given that we are already fairly well advanced in the year. And we confirm we did not factor it in our guidance, but it will have a limited impact on 2025 because we already have inventory in place in the U.S. So I don't think that it will – in fact, with what we know today and with what we read in the media, we don't think that it will impact our guidance in any way for 2025.

Thank you. Hooman, what are you expecting to see?

So, thanks for the question. Taking a step back, I think it's important to think about the atopic dermatitis landscape. And it remains a matter of some concern to me that only 15 or 16% of patients with atopic dermatitis, who are biologically eligible are currently receiving therapies. both from our own molecules and those of other pharmaceutical companies, we welcome new molecules in the space. And I think a leading KOL in the atopic dermatitis space and beyond will welcome more options for their patients. Speaking specifically about amitilamab, The value that we see in this space is that there are a variety of patients that are highly heterogeneous and need a variety of solutions, including the fact that patients who are refractory to current agents demonstrate an upregulation of OX40 ligand in skin biopsies. What does that lead us to believe? All in all, the distillate of that is that I think that a new agent that comes in consistent with our stream AV work that we've previously published that provides both a longer interval of treatment coupled with magnitude of treatment consistent with the standard of care would be significantly and hugely favoured in the marketplace. One other final comment, newer agents that have significantly lower efficacy in the standard of care have already garnered substantial interest. So a molecule that is comparable to the standard of care will be, with a longer interval, very substantially of value.

Yeah, I think, thanks, Jim. I think if you look at stream AD design, we had another arm to explore longer intervals. I think we'd love to see what that could look like. We'll see. The data will tell us. Okay, next question.

Yes, next question from Florence Espedes from Bernstein. Florence? Okay, let's take the next question in between. Next question from . Hi, can you hear me?

Yeah. Hi, thank you for taking my question. So I have a question on flu. You guided a meeting primarily due to price pressure. Could you please provide more color on how Sanofi plans to mitigate this, you know, aggressive pricing dynamic across multiple markets? And how are you thinking about the longer-term pricing dynamics in flu? And also, you know, on top of that, how do you find so far IFP Junior's leadership impact on the flu business in the U.S.? And maybe on top of that, just you got it high single digits for the top line, given the flu headwinds that you have already flagged. I think it actually shows a resilient business on the top line, at least. So can you please walk us through your confidence to reach that top end and which franchise will be doing the heavy lifting in the second quarter? Any color would be appreciated.

Thank you. Thanks for your question, Shirley. On the second part of your first question, I don't have any specific comment on the new administration view on flu, but I can give you a bit more color on how we're seeing the full flu year in 2025. As we've mentioned, and you were making allusion to it. We foresee in 2025 a decrease of our sales in the mid-teens percentage range with a Q3 to Q4 speed of 75-25% speed. You completely understood that it's linked to competitive pricing pressure Let me give you some color around it. First of all, there is a one-off impact in Germany. So it's a one-off effect of 2025 only and will not be replicated in being forward, which is the fact that within the flu recommendation for elder in Germany, there is the addition of an adjuvanted competitor, which automatically reset the price at approximately half what the price was in the previous year. So there's a one-off there in 2025. The second part of that overall decrease for the year is linked to a competitive pricing pressure, mostly in the US and a little bit in the international zones. I think there are a couple of points that are important to highlight. First of all, we are a significant leader in the full market. And let's be very clear, we expect our market share in full to be a solid market share performance in 2025, despite this declining market in value. Again, maintaining our flu leadership position, which obviously comes from the fact that we have a very strong differentiated portfolio with Fluzone IDOs, FLTA, and FluBlock. As for the long-term, well, I think that's quite in line with what we had in view, and that's why we've made the deal with Novavax and Nuvaxovid, because the way we foresee the market to evolve is, first of all, to keep evolving towards more different flu vaccines, like the ones we have, that provide strong efficacy and good safety profile, and on top of that, moving forward to a flu-COVID-19 combination, where, again, you will be able to meet the quality in terms of efficacy of the differentiated flu vaccines, but of course also the tolerability profile. And I think that with our flu COVID-19 portfolio in development, we have a good chance to get there.

Thank you. François? Yes, I'm Shirley. On the question about landing in terms of sales growth for the full year, indeed, we confirm our confidence for the high single-digit level for the full year. First and foremost, we did 9.9% in H1. It does help for the full year. Second, we will continue to have a strong growth with Dupixent. Don't forget that we were at 21% of value growth in Q2. It's amazing, by the way. It's even in the mid-20s by volume, eight years after the launch. Really impressive. It's not only Dupixent, we are not Dupixent dependent. Launches, they contributed 10% of sales, but they also contributed in Q2 almost one-fourth of our growth, and it's gaining traction quarter after quarter. And we have a resilient GenMed business, our established product are very resilient as well. So we do confirm our high single-digit guidance for the full year. Let's be careful with Q3. We have flagged it already since the beginning of the year. We had very high cons last year in Q3. So do expect to see a little bit of a slowdown in Q3 in terms of growth versus what we have experienced in H1. But once again, full confidence with high single-digit. By the way, it takes the opportunity to say it. It's high single-digit with and without a blueprint. So it's not coming from a blueprint, high single-digit. It's coming from the best business. Thank you. Next question.

Let's try again with Florence Espedes from Bernstein. Florence.

Yes, good afternoon. Thank you for taking my questions too, please. First, on Dupixent, could you maybe give a little bit more color on the ramp-up in COPD, as now we have the product available in 13 countries and 6 more to come. Could you share with us where you see the best adoption? and this disease. That's our first question. Second question for Paul. With the recent Brooklyn acquisition and the really late-stage products, is it fair to assume that in the future you will look for earlier phase assets and a transaction that's more on what you used to call bolt-on from 2 to 5 billion? Any call on that would be great. Thank you.

Thank you, Brian. Yeah, so thank you so much for the question. And first and foremost, the double-digit growth that we've seen, just as Francois just said, really comes – from across indications, across geographies. Our base business, actually our base indications of atopic dermatitis, asthma, nasal polyps, some of the first indications, we continue to see strong growth there. But it is really exciting to see also growth coming from new indications, such as COPD, CSU, and even recently BP. Now, specifically as it relates to COPD, about nine months into the launch, we continue to see excitement from customers. And, again, as a reminder, these are customers, these are really largely pulmonologists that have had a great deal of experience with Dupixent and asthma previously. So the best way to look at this, if you really look at the pulmonologist community and you look at how their prescriptions have changed, our volume has really grown strongly in the pulms offices thanks to the launch of COPD in combination, of course, with asthma. And, of course, that is, again, really positive and will continue to develop over time. So really, really important. positive start to the launch of COPD, and we're seeing this pretty consistently across the markets, as you mentioned, 13 and six more to go before the end of the year for launching in COPD.

Thank you, Brian. On the second part that we've guided for quite a while on the two to five range, we have said for maybe the last year or two we'd step outside for the right opportunity, but prefer single-digit. The Blueprint opportunity was right in the sweet spot for us on this immunology rare access and we felt like we were quite uniquely positioned to be able to build on the great work the Blueprint team had done and to really move quickly based on our experience from the world's leading rare disease companies. And I think, don't forget that it's literally just in the launch phase. And, of course, with the LNS behind that and perhaps even more of a, you know, More of a complicated but intriguing step is 808. Further back, it could be a game changer. Of course, these things could disappear quite the end of the night. But we feel like it really matched what we were trying to do. As for deals going forward, we sort of reiterate. I know you might say, well, you just did Blueprint, but we get back into the two-to-five range, not because of the financial piece, but because we continue to look early, early, early, and they tend to be in that range. And we want to maintain our AA rating, or at least we have flexibility there to do that. You know, Francois said it, that our growth profile for the next five-plus years is, you know, in the top group of the industry, right? So it's really the emphasis remains early, early, early, but in the areas that we are strong in where the marginal cost to deploy a new asset would be modest. We just want to keep adding to that because as we get into the early 30s, you know, depending, that's when we need to be in launch swing for some of these assets, so it's better to go early. I think we can't be disciplined. You know, we spend a lot of time on this, and we're very particular about what we think meets our bar, and I think we're happy with how we sit. Okay, next question.

Yes, next question from Sachin Jain from Bofa. Sachin?

Hi there. Thanks for taking my questions. A couple of product ones and then one clarification for me. So on aminotelimab, the answer to the prior question, you flagged the importance of less frequent dosing. We haven't seen, I don't think, the Q12 where you ask for data. So just don't even give on the strength of that data and read to AD. I just wanted to be clear that you put the Q12 data in the AD press releases, I think it's a secondary endpoint. That's the first question. Second question on tolerability in SPMS. As we approach approval, just what should our expectations for the REMS be and how that might impact launch? And then just a quick clarification on a prior question on the BOI for 2026-2027. So we're in no doubt. Should we see BOI margin growth as well as absolute growth? I heard the answer as a comment on absolute BOI, and I think the question was on the margin. Thank you.

Okay, thank you.

Let's give this to him and Amelie. Sachin, thank you for the question. Firstly, on Amelie, when I was referring to Longer Interval earlier, just for clarification for everyone, Paul, I was talking about Q4W. which is a differentiated interval currently for this day-to-day topic demo, which is point one. Point two, and of course, an ongoing theme through our AD trials, starting with stream AD, which is a Q4W dosing, and then into case one and case two, et cetera. So point one is that when I was asked about what a KOL would expect, I meant a Q4W dosing for an abundance of clarification. The second comment was your comment to Q12W, and there are three data points that I would direct you to. Number one is the cessation study of 3MAD, the off-drug study component as it was described. As you know, over 60% of patients had a maintenance of their response at 24 weeks. which is what the inspiration was to have both induction and maintenance Q12W dosing. And as you'll know from the corpus of studies, nine studies in the Oceana study, program, we will see the red thread of QW go through at least four of those studies, which include case one, case two, short, and running into estuary. And the final part of that Emily question was, thank you for noting on the asthma study that the Q12W dosing in asthma was promising, and that adds to our understanding that OX40 ligand modulation two cells in disease does have the potential to have a longer interval interaction. On SPMS and tolobrutinib, the only comment I'll make, and thank you for noting the importance of the REMS, the only comment I'd make is it's a subject of active regulatory discussion, and our practice is not to disclose any specific comments around it, especially at this delicate stage of discussions with the regulator. So we found the collaborative interaction with the regulator extremely gratifying, and that's important. Thank you. Thank you. Francois?

Yes, Sachin. On the increase of BOI, you're absolutely right about what I said. We will see our BOI increasing in absolute value in 26, 27, and in the following years as well. You're right, I said in absolute value. that I'm very confident. That being said, I don't want to commit at this stage as a percentage of sales. Don't forget, this is what I mentioned in my presentation earlier, we have to absorb 1.1 billion of BOI that will not disappear, but that will go to a certain extent because of the end of the regenerant reimbursement of R&D. So that's quite a significant amount. Even if we grow at a high rate, and we will continue growing, I don't want to commit at this stage. We are working on it in order to try to make it valid as well as a percentage of sales, but I don't want to commit at this stage. Okay, thank you. Next question.

Yes, next question from Chemus Fernandes from Guggenheim. Chemus?

Great. Thanks so much for the question. So just wanted to check in on patent estates and the patent portfolio, you know, in terms of how you're thinking about the opportunity there. And then maybe just as an extension to that, lifecycle management opportunities that you see on a go-forward basis with your partner, Regeneron. And then just a quick second question. It seems like you're commenting on the orthogonal combination potential that might exist with OX40. Are you really referring more to the potential to combine amlitalimab with other assets? or are you talking about the prospect of whether it be nanobody or other OX40 ligand combinations? In particular, in HS, at least, we know OX40 and the TNF will be presented, I believe, at the ADB. Just trying to get a sense of your thoughts around how broadly the OX40 mechanism could be applied in various disease states.

Thanks. Thank you, Roy.

I guess the question was about the Pixent, but in general also. For the Pixent, I remind you that the compound pattern expires in the US in March 31. In Europe, it expires in March 33, with all the exclusivities extensions attached to them. As Brian said, we've got eight dedications. We've been spending a huge amount of money on development. You can rest assured that we have ensured that we protected all innovations that the company prepared around the Pixent. And we have a number of patents going well beyond the composition matter patent into the 40s. And it's too early to speculate as and when we'll keep you updated on the relevant developments.

Thank you. Uman Fast, if you can, LCM, with our partner Regeneron.

We obviously have, in discussion with Regeneron, active, ongoing discussions within the Alliance. We work closely with them. We are excited by the ongoing relationship, which is active across the existing molecules, like DP and IttepecMAD, but also potential new opportunities that we're seeking to get. Thank you. And Amelie, Tom Bowes? Well, firstly, let me just say, on our dashboard at the moment, Amelie Mono is... very much in the headlights, windscreen, and every other part of the front of the car. Our focus is 100% on executing, on delivering those studies over the next year or so at large ocean program. And in terms of, so that is absolutely our focus. In terms of combination therapies, OX40 ligand is an important biological node. licensing, B-star biology and far beyond, the opportunity to do combination therapies, as we've already demonstrated, with a positive result in the Brevet and MIG NHS, as you say, which is about to be presented, is going to open a whole new vista. Okay, thank you. Next question.

Next question from Simon Baker from Redburn. Simon?

Thank you for taking my question. Two quick ones if I may please. Firstly, could you just give us an update on the current trends and your outlook with the Bay Fortis in the US and then moving to Blueprint and Blue 808. The literature has been peppered with reports on kit inhibition in inflammatory disease for the thick end of 20 years. So I just wonder if you could give us your thoughts, human, on why you see kit inhibition in that setting as an interesting area and specifically what appeals to you about the blueprint asset. Thanks so much.

So pay-for-tuits, as discussed before, we see some growth for pay-for-tuits overall in 2025. This will come from a market expansion as pay-for-tuits is going to more and more geographies. You know very well that there is a further competition entering into the field. I just want to take the opportunity that while the new product is also Merkle and CBD, both Merkle and CBDs are very different. Extremely very different half-life. BFortis has a half-life of 71 days. Your product has a half-life of 42 days. And very, very different real-world experience with BFortis being studied in a quarter million of babies with outstanding results. Due to that, we expect that overall USVCR will keep increasing this year and next year. It takes three to five years of pediatric intervention for vaccination coverage rate to reach their peak. So overall, RSV prevention will increase and B4-2 will remain the dominant player thanks to its data set.

Thank you.

Briefly, Uman, on the other way. Yeah, Simon, I guess you can never take the chemist out of you when you speak. Firstly, let's start by saying we're honoured and privileged to have the Blueprint team join us. They really are the experts in e-kit biology, and our industry is characterised by experts being able to achieve outstanding results. Speaking very briefly about martial biology, as you know, Based on your background specifically, targeting wild-type CKIT has been a sort of holy grail of the industry for decades. You know very well from the times of William Osler, Sir William Osler, Marcel and their role in inflammation diseases, classical diseases such as asthma, COPD, but far beyond have been important. If we can target wild-type CKIT with an adequate therapeutic index, then it will open up a whole number of endometriosis.

Yeah, I think ultimately it's a nice shot to have in the pipeline. It's been around a long time. If we get it right, this could be great. And if it doesn't, then it's early enough for us to make the tough call. But we're optimistic. Let's see. Okay, next question.

Next question from Sarita Kapila from Morgan Stanley. Sarita?

Hi, thanks for taking my questions. Sorry to come back to margins, but maybe, you know, should we think about 26 margins being flat as a floor? And you provided more colour on refunding income and future royalties, but should we expect divestment income, I believe it's 500 million this year, to continue into 26 and 2027? And then just a quick one on Blueprint and Avakit competition from Cogent's Bezucastinib. Maybe you could have some words on the molecule given the liver tox. I'm sure you diligenced the landscape, but do you believe Blueprint adequately factored competition in the 2 billion peak sales guide? Thank you.

Thank you. Francois? It's under 26. I don't want to die for 26. It's too early to do that. And so we'll do that on due time. But once again, I confirm the fact that we are working towards an increase in BOI next year that will start with the benefit of gross leverage. and strong growth on the top line again. I do confirm what you said, which is we do expect to get probably half a billion. Well, not potentially more, but going from disposals in terms of capital gains from the disposals we regularly had about half a billion might be a little bit more in the future.

I think it's a fantastic question, and I'll start kind of the same way we talk about a lot of the disease states across immunology, which is, first and foremost, this is a very under-penetrated marketplace. They've just launched into this space, and if you look at the growth, For Avakid, it is because they are finding new patients, getting new patients on therapy, keeping new patients on therapy. So as we've said before, new competition into any space like that is actually good for the space from a noise level standpoint, finding these patients. It's a really symptomatic disease state that presents itself on a lot of really important specialists that we call on on a regular basis today and will continue to call on in the future. That said, I think that they have done a very nice job of factoring future competition into the mix, not only for market growth, but also for leadership share. So we feel very confident with Avakit and its profile, especially in recent light of the readout that we just saw from Bezu. All right. Thank you. Next question.

Yes. Next question from Piper Verdult from BNP. Piper?

Yeah, thanks. Just a couple of thoughts. Number one, interesting game team enthusiasm around IL-17 becoming part of your pipeline portfolio in light of the growing opportunity in NHS and competitive data this week showing very promising FCT in atopic dermatitis. And then secondly, Paul, sorry about the obligatory question on U.S. pricing reform and the potential for Europe to step up and share the load. Just interested in what your latest thoughts are. And just a very quick third, if I could squeeze one in, for whom and just when should we expect to hear about next steps and plans and your go-forward strategy on the topic of whether it will get terminated? Is there something that we should expect to hear about this year or are you still doing the work?

Okay, Peter, thanks very much. I'm not sure what the question was in Aisle 17. Was it... I can't read that. So you'll have to tell me what was the question. It was in A.D.? Yes. Okay. I'm not quite... Guys, sorry. Let's go to the other part of the question. Maybe it's a Peckham app, and then I'll answer pricing, and then we'll come back to that question. Okay.

So it's a Peckham app. Okay. We were obviously hoping for better results than a mixed result. We're working closely across the alliance with Regeneron, working through the basis for the difference in RFI 1 and 2. And once we figured that out, you know, we have to recognize that RFI 2 failed. We will go back to the regulator for next steps.

Okay, so then... You know, Peter, maybe it was just us here, but it really broke up on the first part. I think the question was about L17 for sure. The UCB, I think, had some early data. I think that's what we've cobbled together here. Look, we believe the assets we have in AD will be the difference. There's no surprises there. We'll get case one, see how that looks, decide how competitive it is. I think in immunology, impact, whether you can really make a difference, we will see. You know, I'm very familiar with IL-17s, but I think our emphasis has been on breakthrough technologies and opportunities and intervals to try and really improve the patient outcome. U.S. pricing, I think you said, the second part of it, and the relationship between Europe and the U.S., But just very quickly, we don't know the final voting from the White House on how we'll look between the 2 through the 32 investigation, MFN and tariffs. And tariffs, once they're established and we know them, we'll step. Then we'll know what the relationship is like with the other two components and know whether it's a 15% tariff with a caveat or a 15 plus or a 15 less. We don't know. And nobody knows. But we've prepared for delivering the guidance this year. That's the minimum. So don't feel we're casual about it because we're absolutely not. I've been on record as many CEOs now about innovation access in Europe. And there's part of me as a parent and as a member of society would still concern that more than 50% of medicines approved in Europe are not available for patients in Europe. I think The value of a medicine should be paid for. And I think there's a lot of people who could contribute to economies and GDP if medicines were made available to them. I'm as interested in budgets for healthcare giving access to innovation for more patients as I am in the pricing conversation. We will see where it ends up. When we have the facts, we will share them. But we're a healthcare company. We'd like to see more patients get access. Excuse me, more patients get access to more innovation. Next question.

Yes, next question from David Riesinger from Lering. David.

Yes, thanks very much. So I just have one question, please. Could you discuss your expectations for tolobrutinib in PPMS human? And if you could just comment on efficacy expectations and also what you're anticipating from the liver toxicity data in that trial. Thanks very much.

Thank you. Yeah, so thank you for the question succinctly. There's a significant biological overlap between SPMS and PPMS. There was an ancient paper around genetics of progressive disease a couple of years ago from Australia. Our view is there is at least some biological reason to believe that smoldering inflammation and brain compartment inflammation are important in both diseases and that there may be some read-through. We look forward to seeing these results later in the year. And with respect to toxicity profile with liver, we expect it to be commensurate with what we see in SPMS. Okay. I think maybe we have time for one more.

One more question and final from Ben Jackson from Jefferies. Ben?

Great. Thanks for the question. Just one final one for me then on amletelimab. If we think about the efficacy that we've been talking about in several questions here, what is it specifically that you think physicians and patients are looking for in terms of which end point? We've obviously had a lot of noise recently about perhaps how an itch benefit is helping to drive. penetration to the market and clearly within your phasory designs you have built in some itch endpoints into that so I guess which of the endpoints we should be paying most attention to and then secondly is there any reason to believe that the opt 40 mechanism could perhaps have a beneficial effect on itch thank you

Yeah, so again, briefly, I think that your second question first, the ox40 ligand biology that Chimera had already worked out, specifically the ligand, is likely through its effect on T cells and neuroinflammatory axis have an effect certainly on the atopic dermatitis and possibly itch. There's a literature on that. I'm happy to discuss it offline. And with respect to the endpoints, I think that the key here, both regulatory and from a community perspective, is IJ01 and EAZ75 are obviously the things that the entry ticket, and in a disorder which has significant low buy-a-pen rate, I think that those would be the entry tickets for what we do.

Okay, Ben, thanks for that. The last question. We delivered strong performance in Q2 with 10.1% sales growth, refined our 2025 sales guidance. At the same time, we confirmed our guidance strong business EPS rebound. Our pipeline continued to make progress despite the mixed results for ITIPEC, ABAP, and COPD, and we eagerly anticipate several important phase three data readouts in the second half of the year, including Amitalimab, Volabrundum. Augmenting our own pipeline, we close the acquisition of blueprint rare diseases. We'll remain focused on strategically redeploying capital towards pipeline and growth as we continue to advance our strategy. With this, I wish everyone a good summer. We'll close the call.