Sanofi - Earnings Call - Q2 2025

Transcript

Thomas Kudsk Larsen (Head of Investor Relations)

Hello everyone, this is Thomas Kudsk Larsen from the Sanofi IR team. Welcome to the Q2 2025 conference call for investors and analysts. As usual, you can find the slides on sanofi.com. Please turn to slide number three. 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 actual results to differ materially. We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our Form 20-F on file with the U.S. SEC and our French universal registration document for a description of these risk factors. As usual, we'll 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 a maximum of one hour, all included. For 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. For this, I'll hand you over to Paul.

Paul Hudson (CEO)

Thank you and hello everyone on the call. We've 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 Dupixent. 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 EUR 1 billion in sales, continuing the momentum we saw in Q1. Altuvio extended its strong performance, increasing market share through patient switches. The presence of Beyfortus 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.

Q5, 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 hemophilia 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. Dupixent sales reached EUR 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 biologic penetration remains low, as well as by recent launches, including COPD. In the U.S., sales reached EUR 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 U.S., sales again exceeded the EUR 1 billion mark driven by volume growth in key markets. Eight years after its initial launch in atopic dermatitis, Dupixent continues to demonstrate strong and sustained growth, with bullous pemphigoid being its eighth indication approved in the U.S. Our ongoing efforts in deepening biologic penetration and expanding indications support our ambition of reaching sales of approximately EUR 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 Beyfortus 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. François will provide our indication for 2025 Beyfortus 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 Beyfortus. We continue to invest in the future of vaccines, most recently entering an agreement to acquire ViceBio. ViceBio 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 like older adults and those at increased risk of severe RSV and HMPV infections. Moving to slide nine, 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 AYVAKIT in systemic mastocytosis, along with a promising pipeline. We are very encouraged by the strong performance of AYVAKIT, reaching $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 AYVAKIT's potential as the first approved medicine in advanced and indolent systemic mastocytosis. The additional 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 AYVAKIT 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, Toujeo, and Hexaxim through optimized manufacturing, packaging, and production. Thank you. I'll now hand over to François, our CFO, for more details on the financials.

François-Xavier Roger (EVP and CFO)

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, biopharma launches, and by Beyfortus. Gross 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 EUR 1.59, up 8.3%, reflecting our 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 continue to execute our capital allocation priorities. After having received in April around EUR 11 billion from the sale of a controlling stake in Opella, we have been actively redeploying this capital. Indeed, we have announced the acquisition of Dren Bio DR-0201, Vigil Neuroscience, Blueprint Medicines, 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. Third, financial attractiveness. Three of our four announced acquisitions reflect our interest in early-stage assets. While Blueprint Medicines is at the higher end of our targeted price 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 interests 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 EUR 5 billion share buyback program in 2025, with over 80% already completed as of today. We remain firmly committed to completing the full program 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 AMVUTTRA 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 partner. Under the agreement, Regeneron reimburses up to 50% of these cumulative costs 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 EUR 300 million in 2026, followed by a more substantial negative BOI impact of approximately EUR 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, AYVAKIT was recently approved for a new indication in both the U.S. 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.

Beyfortus 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-single-digit percentage versus last year due to competitive forces, in particular in the U.S. 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 -4% on sales and around -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 Medicines, 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 percetage 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 U.S. 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 Houman, who will provide an update on the progress of our innovative pipeline.

Houman Ashrafian (EVP and Head of Research and Development)

Thank you, François. Since our last update, we received U.S. approval for Dupixent, Bullous pemphigoid, and MenQuadfi six weeks, and last week, the EU approval for SARCLISA in newly diagnosed, transplant-eligible patients. Furthermore, Dupixent was submitted for review in Japan for BP and Cerdelga in the U.S. for Gaucher's disease type 3, with an FDA decision expected in January next year. Despite its Bevacizumab's mixed phase III result, our pipeline continues to advance with new rabies vaccines showing consistent phase III efficacy. We secured seven new regulatory designations, including Orphan and Fast Track, and had seven medicines featured in the prestigious journals, which emphasizes our determination to accelerate our commitment in improving R&D. Last quarter, as François said, we acquired DR-0201 from Dren Bio, now entering phase I in immunology.

We've since made two acquisitions: Blueprint Medicines with AYVAKIT and two new potential options in mid-stage clinical development, the potential next-generation molecule LNStimate for mastocytosis and BLU-808 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 antibody from multiple myeloma, which was recently designated an excellent 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 treatments to patients. Next slide. We're committed to addressing the large unmet medical needs for different COPD patients with Dupixent, with its Bevacizumab and lastly, with Lintuzumab.

At ATS, we present cool data from BOREAS and NOTUS phase 3 studies showing significant reductions in exacerbations, FEV1 improvements, and quality of life, confirming our legacy in COPD with Dupixent. For its Bevacizumab, targeting former smokers, we're progressing the data analysis, VERIT1 and VERIT2 phase III studies, including insights from other molecules targeting the same pathway. 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 intention to evaluate linsecumab, our IL-13 TSLP pentavalent NANOBODY, in a Phase 2/3 COPD study this year. Based on its benefits in an existing clinical study and two known and proven mechanisms of action, we have faith in its dual targeting nanobody technology with strong efficacy and proof of concept due to its deeper access into lower respiratory tract airways.

Phase I, b data showed a 40.9% PPV reduction in phenol levels in asthma patients at day 29. The medicine remains our main interest in respiratory conditions thanks to its effect on biomarkers and symptoms. Next slide. Brilzabrutinib 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 has received its first global approval recently in the UAE. Moreover, we're pleased by the recent designations received for Fast Track for IgG4 disease and Orphan Drug for Wegener and sickle cell disease, all in the U.S., and Orphan designation for IgG4 in the EU.

To complement our presence in rare diseases, at ASCO, we presented the subcutaneous SARCLISA data from three studies evaluating the convertibility of SARCLISA 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 are underway, with acceptances expected soon. Finally, F-doralpran alpha, our recombinant human AAT1 fusion protein, is in a Phase II superiority study for AAT 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, batoclimab.

Based on a solid foundation, we're expanding our expertise in 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 disease. Really, povetacicept is 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 PNS 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 riliprubart at 24 weeks. Results from Part B confirmed findings across all CIDP patient subgroups, including those who are on standard of care, refractory, or naive, where patients remain relapse-free and sustain their response at week 76.

Patients showed 35% reduction in NFL levels and a strong and sustained reduction in complement activity compared to baseline. Riliprubart offers potential as a 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 III programs include two studies mobilized for patients who have experienced failure or inadequate response to standard of care therapies, which are mostly IVIG or steroids depending on the country, and VITALIZE is 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 for efzofitimod in AATD and donidalorsen with Orano Med, and two significant phase III readouts with tolibrutinib in PPMS and the first data for amlitelimab in AD this year. Next year, we expect the remaining phase III data for amlitelimab 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 for longer dosing interval, potentially possible with OX40 ligand modulation on top of the AD phase II 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, and we're chasing numerical science to improve the lives of patients. With this, I will hand back to Paul.

Paul Hudson (CEO)

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 to submit your question by clicking the Q&A icon at the bottom of the screen. Your question will be read by our panelist. Now we'll take the first question. Please go ahead.

Operator (participant)

Yes. The question is from Louisa Hector from Berenberg. Louisa.

Luisa Hector (Analyst)

Hi there. Thank you for the call. 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. 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. If we go back to your December 2023 R&D Day where you laid out some objectives, you were targeting a 50% increase in phase III trials for this year, 2025. You highlighted the new launch cohort with risk-adjusted sales over EUR 10 billion in 2030 and your 12 blockbuster assets, of which three of those could be over EUR 5 billion. I wonder if you could just comment on those specifically. Are you on track for the phase III trials?

Are you more confident in your EUR 10 billion by 2030? If so, has the mix changed now that you have more data in-house? Thank you.

Paul Hudson (CEO)

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

Houman Ashrafian (EVP and Head of Research and Development)

Yeah. Louisa, thank you for the question, and I'll try to remain succinct. Sanofi 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. 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, 2023, amlitelimab was one of the three, as were frexalimab and belrestotug. We remain committed to all the molecules in our portfolio.

Amlitelimab will read out in the relatively near future with its first phase III. We look forward to pressure testing our predictions. I'll stop there and hand over to Paul.

Paul Hudson (CEO)

Yeah. I mean, Louisa, I think it's fair to say we've had plenty of time to reflect on the ups and downs of this year. While not everything has gone our way, the data sets have allowed us to do some good thinking around how to go forward or not, as the case may be. I think Houman used the word humble, and I would add to that because I think this transformation has been moving at such a pace 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 we will continue to push science, of course, as expected of us. What we would like to avoid is stubbing our own toe. 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. I think you're right, by the way, that for some the jury remains out, but the progress is one thing, and it's revealing itself in successful phase IIIs. I think I said this, I think maybe it was you that asked me a question for reflection on a previous call. I'd like to think these things could have been done faster, but I've learned a few things about being patient. We have to do good work, be diligent, be accurate and factual, and then we just have to turn the cards over.

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.

Operator (participant)

The next question is from Richard Vosser from JPMorgan. You're good.

Richard Vosser (Analyst)

Thanks for taking my question. First question, just on development of spend, 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 2026 as well. You potentially have some interesting launches, maybe at the latter end of that year and in 2027. Should we think SG&A goes up from here? R&D as well. Have we reached a level with the trials that you're starting? Should we expect that and Blueprint to go up as well? How should we think about the margin in 2026? Is that sort of at a similar level of 2025? 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.

Paul Hudson (CEO)

Thanks, Richard. I think 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?

François-Xavier Roger (EVP and CFO)

Richard, it's a good question, for speaking. On R&D. Obviously, I mean, we reported an increase of 17% in the quarter, but if you put aside the exceptional revenue that we had from SOVI 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. 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 Medicines, but I mean, again, the guidance that we gave initially at the beginning of the year, we will be there. There is a little bit of a phasing issue between H1 and H2. I have no concern whatsoever. On SG&A, 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&A, 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. 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. 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 2026 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 because it will depend on readouts, and it may be impacted a little bit as well by some acquisitions in BD and M&A. We don't have necessarily the full visibility of where we can go year by year at this point in time.

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 regenerative end of R&D reimbursement, that one we will be able to absorb in BOI. Do expect to see our BOI increasing year after year. I'm very confident about it.

Paul Hudson (CEO)

Thank you, François. I think Houman well said, attractive growth profile, tight management on OpEx. R&D broadly flat depending on successes or the opposite in R&D for this year and a little bit beyond, we'll see. We overlay that with being one of the companies with the lowest generalization profiles over the next five, six, seven, eight years. It's important that we advance the medicines that drive the growth and then fund the launches. 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, Dupixent, China.

Brian Foard (EVP and Head of Specialty Care)

Thank you, Richard, so much for the question. I'll come to China in just a second. As you probably know, Dupixent's a pretty diversified product now around the world, a bunch of different indications. We're in eight, as Paul alluded to already, in the Unite States. While China is a very important marketplace, it is one of many where we're actually seeing continued underlying volume growth. 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 NRDL actually eventually. 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.

Paul Hudson (CEO)

Okay. Next question, please.

Operator (participant)

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

Matthew Weston (Analyst)

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

Paul Hudson (CEO)

Let's start there, François-Xavier.

François-Xavier Roger (EVP and CFO)

Yes, Matthew. It's difficult to comment on what we don't know. We have run different scenarios, obviously, and 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. 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. I don't think that it will, in fact, with what we know today and what we read in the media, we don't think that it will impact our guidance in any way for 2025.

Paul Hudson (CEO)

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

Houman Ashrafian (EVP and Head of Research and Development)

Thanks for the question. Taking a step back, I think it's important to think about the atopic dermatitis landscape. It remains a matter of some concern to me that only 15% or 16% of patients with atopic dermatitis, which are biologically eligible, are currently receiving therapies. Both from our own molecules and those of other pharmaceutical companies, we welcome new molecules in this space. I think a leading KOL in the atopic dermatitis space and beyond will welcome more options for their patients. Speaking specifically about amlitelimab, 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 SREAM-AD work that we previously published, that provides both longer interval of treatment coupled with magnitude of treatment consistent with the standard of care would be significantly and hugely favored in the marketplace. One other final comment. Newer agents that have significantly lower efficacy than the standard of care have already garnered substantial interest. A molecule that is comparable to the standard of care will be, with a longer interval, very substantially of value.

Paul Hudson (CEO)

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

Operator (participant)

Yes, next question from Florent Cespedes from Bernstein. Laurent? Laurent? Okay, let's take the next question in between. Next question from Shirley Chen, sorry, from Barclays.

Shirley Chen (Analyst)

Hi, can you hear me?

Yeah.

Hi, thank you for taking my question. 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 aggressive pricing dynamic across multiple markets? How are you thinking about the longer-term pricing dynamics in flu? Also, on top of that, how do you find so far IFP Junior's leadership impact on the flu business in the U.S.? You guided high single digit 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. 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.

Paul Hudson (CEO)

Thanks.

François-Xavier Roger (EVP and CFO)

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 are 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 % range with a Q3-Q4 split of 75%, 25% split. You completely understood that it's linked to a competitive pricing pressure. Let me give you some color around it. First of all, there is a one-off impact in Germany.

It's a one-off effect of 2025 only, and will not replicate moving forward, which is the fact that within the flu recommendation for elderly in Germany, there is the addition of an adjuvanted competitor, which automatically resets the price at approximately half what the price was in the previous year. 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 U.S. and a little bit in the international zones. I think there are a couple of points that are important that we are to highlight. First of all, we are a significant leader in the flu market. Let's be very clear, we expect our market share in flu 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 A, Fluzone B, and Flublok. As for the long term, 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 differentiated flu vaccines like the ones we have, that provide strong efficacy and good safety profile. On top of that, moving forward to a flu COVID-19 combination where you will be able to meet the quality in terms of efficacy of the differentiated flu vaccines, but of course also the tolerability profile. I think that with our flu COVID-19 portfolio in development, we have a good chance to get there.

Paul Hudson (CEO)

Thank you, François.

François-Xavier Roger (EVP and CFO)

Yes, on 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, which 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 contributed 10% of sales, but they also contributed in Q2 almost one-fourth of our growth, and it's gaining traction quarter after quarter. We have a resilient gen-med business, our established products are very resilient as well. 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 comps 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, I take the opportunity to say it. It's high single-digit with and without Blueprint Medicines. So it's not coming from Blueprint, high single-digit. It's coming from the best business.

Paul Hudson (CEO)

Thank you. Next question.

Operator (participant)

Thanks. Let's try again with Florent Cespedes from Bernstein. Florent.

Florent Cespedes (Analyst)

Yes, good afternoon. Sorry, Bernard, 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 six more to come? Could you share with us where you see the best adoption in this disease? That's our first question. Second question for Paul on FDA. With the recent Brooklyn acquisition and late-stage product, is it fair to assume that in the future you will look for earlier phase assets and a transaction at a more on what you used to call bolt-on around $2-$5 billion? Any color on that would be great. Thank you.

Paul Hudson (CEO)

Thank you, Brian.

Brian Foard (EVP and Head of Specialty Care)

Thank you so much for your question. First and foremost, the double-digit growth that we've seen, just as François-Xavier Roger 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. 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. As a reminder, these are customers, these are really largely pulmonologists that have had a great deal of experience with Dupixent and asthma previously.

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 pulmonologist offices, thanks to the launch of COPD in combination, of course, with asthma. That is, again, really positive and will continue to develop over time. Really positive start to the launch of COPD. 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.

Paul Hudson (CEO)

Thank you, Brian. On the second part, we've guided for quite a while on the two to five range. We had said for maybe the last year or two, we'd step outside for the right opportunity, but first single-digit. The Blueprint Medicines opportunity was right in the sweet spot for us on this immunology rare access. We felt like we were quite uniquely positioned to be able to build on the great work the Blueprint Medicines team had done and to really move quickly based on our experience from the world's leading rare disease companies. I think don't forget that it's literally just in the launch phase. Of course, with the LNSDNIB behind that, and perhaps even more of a complicated but intriguing step is 808 further back. It could be a game changer. Of course, these things could disappear quietly into the night.

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, you just did Blueprint Medicines, 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. We want to maintain our AA rating, or at least we have flexibility there to do that. You know, François said it, that our growth profile for the next five plus years is in the top group of the industry. 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 2030s, depending, that's when we need to be in launch swing for some of these assets. It's better to go early. I think we try and be disciplined. We spend a lot of time on this, and we're very particular about what we think meets our bar. I think we're happy with how we sit. Okay. Next question.

Operator (participant)

Yes. Next question from Sachin Jain from BofA. Sachin.

Sachin Jain (Analyst)

Hi there. Thanks for my questions. A couple of follow-up ones and then more clarification from me. On amlitelimab, the anticipated question, you flagged the importance of less frequent dosing. We haven't seen, I don't think, the Q12 week asthma data. I'm just only collecting it from the strength of that data and read to AD. I just wanted to be clear that you put the Q12 week data in the AD press release, as 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? Just a quick clarification on a prior question on the BOI for 2026-2027 there are 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.

Paul Hudson (CEO)

Okay. Thank you. Let's give this to him and amli.

François-Xavier Roger (EVP and CFO)

Sachin, thank you for the question. Firstly, on amli, when I was referring to longer interval earlier, just for clarification for everyone on the call, I was talking about Q4W, which is a differentiated interval currently for the atopic demo, which is 0.1, 0.2. Of course, an ongoing theme through our AD trial, starting with STREAM-AD, which was a Q4W dosing, and then into CASE 1 and CASE 2, etc. 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 STREAM-AD, 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 an induction and maintenance Q12W dosing. As you'll know from the corpus of studies, nine studies in the OCEANIS program, we will see the red thread of QW go through at least four of those studies, which include CASE 1, CASE 2, SHORT, and running into ESTUARY. The final part of that amli question was, thank you for noting on the asthma study that the Q12W dosing in asthma was promising. That adds to our understanding that OX40 ligand modulation of T cells in disease does have the potential to have a longer interval interaction.

On SPMS and tolibrutinib, 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 this, especially at this delicate stage of discussions with a regulator. We found the collaborative interaction with the regulator extremely gratifying. That's important.

Paul Hudson (CEO)

Thank you. Thank you, François.

François-Xavier Roger (EVP and CFO)

Sachin, on the increase of BOI, you are absolutely right that what I said, we will see our BOI increasing in absolute value in 2026, 2027, 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 % 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 Regeneron reimbursement of R&D. 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.

Paul Hudson (CEO)

Okay, thank you. Next question.

Operator (participant)

Yes. Next question from Seamus Fernandez from Guggenheim. Seamus.

Seamus Fernandez (Analyst)

Great. Thanks so much for the question. Just wanted to check in on patent estates and the patent portfolio in terms of how you're thinking about the opportunity there. Maybe just as an extension to that, lifecycle management opportunities that you see on a go-forward basis with your partner Regeneron. Then just a quick second question. It seems like you're commenting on the orthogonal combination potential that might exist with AUX40. Are you really referring more to the potential to combine amlitelimab 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 EADV. Just trying to get a sense of your thoughts around how broadly the OX40 mechanism could be applied in various disease states. Thanks.

Paul Hudson (CEO)

Thank you, Brian.

Houman Ashrafian (EVP and Head of Research and Development)

I guess the question was about Dupixent, but in general, also for Dupixent, I remind you that the compound patent expires in the U.S. in March 2031. In Europe, it expires in March 2033, with all the exclusivity extensions attached to them. As Brian said, we've got eight indications. We've been spending a huge amount of money on development. You can rest assured that we have ensured that we protected all the innovations that the company prepared around Dupixent. We have a number of patents going well beyond the composition of matter patent into the 2040s. It's too early to speculate as and when. We'll keep you updated on the relevant developments.

Paul Hudson (CEO)

Thank you. Houman, if you can, lifecycle management with our partner Regeneron.

Houman Ashrafian (EVP and Head of Research and Development)

The LCM 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 Dupixent and ethmoid, but also potential new opportunities that we're seeking to get.

Paul Hudson (CEO)

Thank you. And amli and tolibrutinib.

François-Xavier Roger (EVP and CFO)

Firstly, let me just say, on our dashboard at the moment, amli 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, a large Oceana program. That is absolutely our focus. In terms of combination therapies, OX40 ligand is an important biological node, licensing B12 biology and far beyond the opportunity to do combination therapies, as we've already demonstrated with a positive result in rivicamtinib in HS. As you say, which is about to be presented, is going to open a whole new vista.

Paul Hudson (CEO)

Okay, thank you. Next question.

Operator (participant)

Next question from Simon Baker from Redburn. Simon.

Simon Baker (Analyst)

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 for Beyfortus in the U.S.? Moving to Blueprint Medicines and AYVAKIT. The literature has been peppered with reports on KIT inhibition and inflammatory disease for the thick end of 20 years. I just wonder if you could give us your thoughts, Houman, on why you see KIT inhibition in that setting as an interesting area and specifically what appeals to you about the Blueprint Medicines asset. Thanks so much.

Paul Hudson (CEO)

Toma, Beyfortus.

François-Xavier Roger (EVP and CFO)

Beyfortus, as discussed before, we see some growth for Beyfortus overall in 2025. This will come from market expansion, as Beyfortus is going to more and more geographies. You know very well that there is further competition entering into the field. I just want to take the opportunity that while the new product is also a monoclonal antibody, both monoclonal antibodies are very different, extremely very different half-life. Beyfortus has a half-life of 71 days. The other product has a half-life of 42 days. Very, very different real-world experience with Beyfortus being studied in a quarter million babies with outstanding results. Due to that, we expect that overall U.S. VCR will keep increasing this year and next year. It takes three to five years of a pediatric intervention for vaccination coverage to reach their peak.

Overall, our risk prevention will increase, and Beyfortus will remain the dominant player thanks to its dataset.

Paul Hudson (CEO)

Thank you. Briefly, Houman, on 808.

Houman Ashrafian (EVP and Head of Research and Development)

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

Paul Hudson (CEO)

I think, Marcelo, 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. 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.

Operator (participant)

Next question from Sarita Kapila from Morgan Stanley. Sarita.

Sarita Kapila (Analyst)

Hi. Thanks for taking my questions. Sorry to come back to margins, but maybe should we think about 2026 margins being flat as a floor? You provided more color on refunding income and future royalties, but should we expect divestment income, I believe it's $500 million this year, to continue into 2026 and 2027? Just a quick one on Blueprint Medicines and AYVAKIT competition from Cogent's bezuclastinib. 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 Medicines adequately factored competition in the $2 billion peak sales guide? Thank you.

Paul Hudson (CEO)

Thank you, François.

François-Xavier Roger (EVP and CFO)

It's on the 2026. I don't want to guide for 2026. It's too early to do that. We'll do that in due time. Once again, I confirm the fact that we are working towards an increase in BOI next year that will start with the benefit of growth leverage and strong growth on the top line. I do confirm what you said, which is we do expect to get probably $500 million, why not potentially more, by the way, from disposal in terms of capital gains from the disposal itself. We regularly had about $500 million. Might be a little bit more in the future, but at least that amount.

Paul Hudson (CEO)

Okay. I wonder, actually, Brian, complexness of AYVAKIT.

Brian Foard (EVP and Head of Specialty Care)

Yeah, I think it's a fantastic question. 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 underpenetrated marketplace. They've just launched into the space. If you look at the growth for AYVAKIT, it is because they are finding new patients, getting new patients on therapy, keeping new patients on therapy. 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 at a lot of really important specialists that we call 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. We feel very confident with AYVAKIT and its profile, especially in recent light of the readout that we just saw from Berenberg.

Paul Hudson (CEO)

All right. Thank you. Next question.

Operator (participant)

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

Peter Verdult (Analyst)

Yeah, thanks. Peter, BNP. Just a couple of full. Number one, interesting gain in development enthusiasm around IL-17 becoming part of your pipeline portfolio in light of the growing opportunity in HS and competitor data this week showing very promising efficacy in atopic dermatitis. Secondly, Paul, sorry, but 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. Just a very quick third, if I could squeeze one in for Houman. Just when should we expect to hear about next steps and plans and your go-forward strategy on it to pick a member whether it will get terminated? Is that something that we should expect to hear about this year, or are you still doing the work?

Paul Hudson (CEO)

Okay, Peter, thanks very much. I'm not sure what the question was on IL-17. Was it? I can't read that. You'll have to tell me what was the question. It was in AD? Yeah. Okay. I'm not quite sure. Sorry. Let's go to another part of the question. Houman, maybe it's a better map, then I'll answer pricing, and then we'll come back to that question.

Houman Ashrafian (EVP and Head of Research and Development)

Okay. It's a better map. 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. Once we figured that out, we have to recognize that RFI 2 failed. We will go back to the regulator for next steps.

Paul Hudson (CEO)

Okay. Peter, maybe it was just us here, but you really broke up on the first part. I think the question was about IL-17 for sure. 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, there's always an opportunity to show an impact, whether you can really make a difference. We will see. 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 in the second part of it, and the relationship between Europe and the U.S.

Just very quickly, we don't know the final voting from the White House on how we'll look between the 232 investigation, MFN, and tariffs. Tariffs, once they're established and we know them, important 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+ or a 15-. We don't know. Nobody knows. We're prepared for delivering the guidance this year. That's a minimum. Don't feel casual about it because we're absolutely not. I've been on record as many CEOs now about innovation access in Europe. There's part of me as a parent and as a member of society still concerned 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.

I think there's a lot of people who could contribute to economies in 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 nets out. When we have the facts, we will share them. 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.

Operator (participant)

Yes. Next question from David Risinger from Leerink. David?

David Risinger (Analyst)

Yes. Thanks very much. I just have one question, please. Could you discuss your expectations for tolibrutinib in PPMS, Houman, 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.

Paul Hudson (CEO)

Thank you. Houman.

Houman Ashrafian (EVP and Head of Research and Development)

Thank you for the question. Succinctly, there's a significant biological overlap between SPMS and PPMS. There was a Nature paper around the genetics of progressive disease a couple of years ago from Australia. Our view is there is at least some biological reasons 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. With respect to toxicity profile with the liver, we expect it to be commensurate with what we see in SPMS.

Paul Hudson (CEO)

Okay, I think maybe we have time for one more.

Operator (participant)

One more question. Final from Ben Jackson from Jefferies. Ben?

Ben Jackson (Analyst)

Great. Thanks for the question. Just one final one for me then on amlitelimab. 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 endpoint? We've obviously had a lot of noise recently about perhaps how an itch benefit is helping to drive penetration to the market. Clearly, within your phase three designs, you have built in some itch endpoints into that. I guess, which are the endpoints we should be paying most attention to? Secondly, is there any reason to believe that the OX-40 mechanism could perhaps have a beneficial effect on itch? Thank you.

Houman Ashrafian (EVP and Head of Research and Development)

Yeah. Briefly, I think that your second question first, the OX-40 ligand biology that Chimera had already worked out, specifically the ligand, is likely to its effect on T cells. Inflammatory.

Axes have an effect, certainly on the atopic dermatitis and possibly itch. There's literature on that. Happy to discuss it offline. With respect to the endpoint, I think that the key here, both regulatory and from a community perspective, is IJ01, and EAZ75 are obviously the things that are the entry ticket. In a disorder which has significant low biopen rate, I think that those would be the entry tickets for what we do.

Paul Hudson (CEO)

Okay, Ben, thanks. 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 its effect environment COPD, and we eagerly anticipate several important phase three data readouts in the second half of the year, including amlitelimab, followed Brendan. Augmenting our own pipeline, we closed the acquisition of Blueprint Medicines rare diseases. We will 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.