管理層發言
Hello, everyone, this Thomas Kudsk Larsen from the Sanofi IR team. Welcome to the Q4 and Full Year 2025 Conference Call for investors and analysts. As usual, you can find slides on sanofi.com. Please turn to Slide #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 risks 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 Q4 or full year 2025 unless stated otherwise.
Please turn to Slide #4. First, we have a presentation, which is a little longer due to full year results, then we will take your questions. We aim at keeping it all to 1 hour, perhaps a little bit more, including questions. We appreciate other companies are also reporting today. For the Q&A, we have Olivier, Brian, and Thomas to cover our global businesses as well as Roy, our General Counsel; and Brendan, Head of Manufacturing and Supply. With all of this, I'll now hand you over to Paul.
Well, thank you, and hello, everyone. In 2025, we continued to develop into an R&D-driven, AI-powered biopharma company. Our strategic progress was supported by the completion of the Opella transaction, allowing us to reinvest proceeds into business development and M&A opportunities while completing our EUR 5 billion share buyback program. We delivered strong performance with 9.9% sales growth, and new launches reached EUR 5.7 billion in sales. We're pleased to have achieved another blockbuster milestone last year, ALTUVIIIO. We successfully launched 2 new medicines, Qfitlia for hemophilia and Wayrilz for ITP, and one vaccine, Nuvaxovid to protect against COVID-19. We also achieved several positive Phase III results, including most of the amlitelimab program in AD and the SARCLISA, a subcutaneous formulation. Our innovation engine continues to make progress, replenishing Phase I, including 3 promising gene therapies, our entry into ophthalmology.
Looking at Q4 performance on Slide 6, we delivered very strong results with EUR 11.3 billion in sales and 13.3% growth, supported, of course, by our key drivers. Turning to our launches on Slide 7. I'm pleased to report that our newly launched medicines and vaccines grew 34% in 2025. Beyfortus continued to deliver with EUR 1.8 billion in full-year sales, demonstrating the critical need for RSV protection. ALTUVIIIO achieved blockbuster status, reaching EUR 1.2 billion in full-year sales. Patient adoption continues to increase, with patients switching from both factor and non-factor medicines. Of note, AYVAKIT reached $725 million in annual pro forma sales, slightly ahead of Blueprint's expectations from early 2025. Our newly launched medicines and vaccines demonstrate our commitment to innovation and the strength of our commercial organization. Moving to Slide 8. Dupixent reached EUR 4.2 billion in the quarter and EUR 15.7 billion in annual sales.
Continued growth across anchor indications and expansion into COPD, CSU, and BP drove a more than 30% increase in patients over the past year. This underscores Dupixent's standing as the #1 prescribed biologic across dermatologists, pulmonologists, allergists, and ear, nose, and throat specialists. The U.S. regulatory acceptance for the allergic fungal rhinosinusitis indication in November brings us closer to a potential ninth indication, further expanding Dupixent's reach. Turning to vaccines. We maintain our leadership in influenza and RSV despite a challenging environment. Full year sales reached EUR 7.9 billion. In influenza, we gained U.S. market share with the Fluzone High-Dose and Flublok, while Europe saw continued penetration of Efluelda and Supemtek. Beyfortus delivered a strong performance, growing 9.5% to EUR 1.8 billion, ahead of our anticipated modest growth and driven by geographic expansion across Europe and the rest of the world.
With real-world evidence confirming 87% to 98% effectiveness, Beyfortus has protected more than 11 million babies in more than 45 countries, thus preventing an estimated 200,000 hospitalizations to date. We continue to strengthen our vaccines portfolio with strategic acquisitions that enhance our ability to protect older adults from serious diseases. In December, we completed the acquisition of Vicebio, adding a bivalent RSV plus human metapneumovirus vaccine candidate to our pipeline. This program complements our existing RSV franchise and leverages the innovative molecular clamp technology for vaccine antigen design. We also announced our proposed acquisition of Dynavax Technologies Corporation, which we expect to close in the first quarter this year. This acquisition adds HEPLISAV-B to our portfolio, the leading adult hepatitis B vaccine in the U.S. with a differentiated and convenient 2-dose schedule.
It also brings a shingles vaccine candidate currently in Phase I/II studies, further expanding our pipeline in vaccines for older adults. These strategic additions reinforce our commitment to innovation in vaccines. Before moving to financials, I'm pleased to highlight Sanofi's key role in developing publicly available specification 2090 or PAS 2090, the first industry-wide global standard for measuring and reducing environmental impact of medicines and vaccines across their life cycle, recently published, by the way, in the British Standards Institution. We codeveloped this harmonized framework with industry to enable ecodesign for footprint reduction, accurate environmental reporting while addressing growing stakeholder demands for transparency. PAS 2090 marks an important moment for sustainable health care, showcasing how collaboration across the health care system can drive meaningful progress.
True patient care means protecting not just individual health, but also planet health. The standard helps us to do both. Thank you. I'll now hand over to François, our CFO, for more details on the financials.
Thank you, Paul, and hello to everyone. Next slide, please. I'm pleased to report that we achieved our strongest quarterly sales growth in Q4 2025. Net sales grew by 13.3% to EUR 11.3 billion. Dupixent delivered double-digit growth with continued penetration across all indications. Dupixent also benefited from a favorable basis of comparison due to gross to net price adjustments in the previous year. Business EPS growth was strong at 26.7%, reflecting our disciplined execution on operational leverage. Slide 14, please. Over the past 3 years, volume growth has accelerated and reached 34% on a compounded basis. Growth was driven by our successful launches and by Dupixent expansion across multiple indications, which continues to drive significant volume uptake 8 years after the launch. Our ability to expand market reach while growing our margins demonstrates the strength of our innovation and our strong commercial execution.
To meet growing patient demand and deliver on our MFN commitment, we will continue investing in manufacturing capacity with a strategic focus on the U.S. Next slide, please. Our full year 2025 results showcase the power of our business model, delivering strong growth with increased profitability. Sales reached EUR 43.6 billion, representing 9.9% growth at constant exchange rates at the upper end of our guidance. This represents a higher underlying growth level than in 2024, given that we excluded hyperinflation impacts from our sales growth at the beginning of 2025. Business gross margin expanded by 1.8 percentage points to 77.5%, driven by favorable product mix and operational efficiencies. Operating expenses increased by 7.9% as we increased R&D investments and supported our new product launches through sales and marketing investments. OpEx has decreased as a percentage of sales to 39.9%, thanks to our efficiency programs.
Business operating income increased by 11.9%, with BOI margin reaching 27.8%. Business EPS, excluding share buyback, grew by 12.2%, in line with our guidance. And including share buyback, our business EPS grew by 15%. This demonstrates our ability to grow EPS faster than sales while investing in future growth. Moving to Slide 16. Our free cash flow has returned to strong levels in 2025 at EUR 8.1 billion, representing 18.5% of sales. We aim to sustainably reach free cash flow of at least 20% of net sales in the medium term. This strong cash flow generation illustrates the quality of our earnings and the effectiveness of our working capital management. A key contributor to this performance was our inventory optimization as we reduced inventory by nearly 30 days. We are targeting a similar inventory reduction in 2026, which will help us to progress toward our 20% free cash flow target. This disciplined approach provides us with significant financial flexibility to execute our capital allocation strategy.
Next slide, please. We ended 2025 with a strong capital structure, as highlighted by our low net debt, which increased slightly to EUR 11 billion. We maintained a conservative 0.8x net debt-to-EBITDA ratio. This conservative leverage provides flexibility for future external growth opportunities even while maintaining our AA rating. We successfully deployed the EUR 10.4 billion received from the Opella divestment into value-creating business development and M&A opportunities such as Blueprint, Vicebio, Dren Bio, DR-0201, Vigil, and some others as well. These divestments and acquisitions allowed us to accelerate our transformation as a biopharma company. Moving to the next slide. In 2025, we executed our capital allocation strategy across all 4 priorities. We significantly increased our organic growth investments in R&D, commercial capabilities, CapEx, and digital transformation. These investments fuel both current and future growth.
As I just mentioned, we deployed the Opella proceeds into strategic acquisitions. We proposed to increase our dividend for the 31st consecutive year to EUR 4.12, up by 5% from the previous year. Finally, we completed our EUR 5 billion share buyback program. We will pursue our capital allocation policy in 2026. Regarding share buybacks, we will execute a EUR 1 billion share buyback program in 2026. The consistency of this approach demonstrates our commitment to sustainable value creation and shareholder returns while investing in long-term growth opportunities. Slide 19, please. Looking ahead to 2026, we expect to deliver a year of profitable growth close to what we achieved in 2025. For the full year 2026, we guide for high single-digit growth in sales and for profitable growth, meaning business EPS growing slightly faster than sales. Be aware that this guidance is for the full year 2026 and does not necessarily apply individually to each and every single quarter in 2026.
Sales dynamics include further portfolio optimization through divestments that will reduce sales by about EUR 200 million in 2026. We expect vaccine sales to slightly decline in 2026. Our gross margin expansion is expected to continue with minimal tariff impact following the agreement reached with the U.S. administration last December. Underlying R&D will increase moderately. In addition to this organic growth of R&D expenses, we have added a placeholder for potential future acquisitions, particularly for Phase I and Phase II assets. Sales and marketing expenses will increase to support growth and launches, while we continue to target stable G&A expenses. Our operating income is expected to include around EUR 500 million of capital gains from disposal. As a reminder, the profit-sharing line in our P&L is increasing faster than sales growth by more than 10 percentage points. We now expect a decrease of around EUR 400 million in R&D reimbursement coming from Regeneron this year.
This decrease will be more than offset by Amvuttra royalties, which are estimated at approximately EUR 1 billion based on the latest consensus. This results in a positive impact of around EUR 500 million to BOI. Our financial outlook includes an increase of our financial expenses this year, driven by increased net debt from both 2025 and 2026 BD and M&A activities. Finally, we expect a stable effective tax rate.
Thank you, François. 2025 has been a year of significant delivery across our pipeline. I'll walk you through the highlights. On pipeline delivery, we achieved 12 Phase III readouts and 15 Phase II readouts and then added 10 new molecules to Phase I, including 3 gene therapies, emphasizing our greater focus on research, supported by business development to replenish our early-stage pipeline. On the regulatory front, we obtained 20 regulatory approvals and 22 acceptances, including 9 priority reviews, in addition to other designations, underscoring the progress we've made. Most importantly, we provided patients with 3 new medicines and vaccines: Qfitlia, the first RNAi antithrombin medicine in hemophilia approved in the U.S. and China; Wayrilz, the first BTK inhibitor in ITP approved in the U.S. and EU; and our recombinant COVID-19 vaccine with full approval in the U.S. and the EU. All these highlights represent meaningful progress in delivering transformative medicines and vaccines to patients worldwide.
Please turn to the next slide. Turning to the Q4 highlights, where we received approvals, including Dupixent for CSU in the EU, Tzield for Stage 2 T1D in the EU, Wayrilz for ITP in the EU, Cerezyme for Gaucher disease Type 3 in the U.S. We strengthened our position in China with 4 approvals, something that I will return to again today. We received regulatory submission acceptance for Dupixent's AFRS in the U.S., Tzield Stage 2 T1D for children in the U.S. and SP0087 rabies vaccine in the EU. On Phase III readouts, amlitelimab delivered more positive results in atopic dermatitis and Dupixent met its primary endpoint in AFRS. Tolebrutinib did not meet its primary endpoint in the PERSEUS study for PPMS. As a result, we will not pursue its regulatory submission. Ending with pivotal Phase III starts, we initiated the second lunsekimig study for COPD, 2 duvakitug studies, each in Crohn's disease and in ulcerative colitis, and in 1 Wayrilz in IgG4-related disease.
Next slide, please. I start with amlitelimab, whose recent data provides increasing confidence in progressive long-term sustained benefit and patient convenience. Data across COAST 1, COAST 2, and SHORE Phase III studies and the ATLANTIS open-label Phase II study demonstrated progressively increasing efficacy over time, with no evidence of plateau through week 24 to 52. This validates the potential for both monthly and quarterly dosing from the start, offering significant patient convenience as either monotherapy or combined with topical corticosteroids, an important background therapy used in the real world. Amlitelimab was well tolerated with an acceptable safety profile. Much of our amlitelimab OCEANA global atopic dermatitis program has now been delivered, including Phase II and Phase III studies evaluating its efficacy and safety when administered in monotherapy and in combination. Remaining studies, AQUA in patients with background TCS and TCI with inadequate response to biologics or JAK inhibitors and ESTUARY, the randomized maintenance study.
We expect both readouts in the second half of 2026, completing our comprehensive package for regulatory submission. Next slide, please. China remains a strategic priority with significant progress made by our regional team. We obtained approvals for global medicines, Cablivi, our anti-von Willebrand factor antibody for acquired TTP and Qfitlia. For China-only medicines, we received approvals for Myqorzo for obstructive hypertrophic cardiomyopathy and for Redemplo in patients with familial chylomicronemia syndrome. These approvals demonstrate our commitment to bringing innovative medicines and treatments to Chinese patients and to leverage Chinese innovation in doing so. Next slide, please. Now let me share an update on our key mid- and late-stage pipeline projects. Our immunology pipeline has been strengthened by having delivered most of amlitelimab's Phase III programs in AD and duvakitug having advanced to Phase III for CD and UC.
Lunsekimig will provide data in asthma this half and has potential for life cycle opportunities. Brivekimig is now moving to Phase IIb. In neurology, tolebrutinib is still under review for the EU SPMS, frexalimab in Phase III for RMS and SPMS, and riliprubart for Phase III for CIDP, the latter 2 with data already next year. In rare disease and oncology, Wayrilz is making progress with its life cycle planned beyond ITP, venglustat in Phase III for GD3 data coming very soon, and Sarclisa expanding with a subcutaneous formulation. Our vaccines portfolio includes multiple programs across pneumococcal disease, yellow fever, meningitis, RSV, and pandemic preparedness. Next slide, please. On my last slide, I'll cover the '26 and '27 news flow updates since December's year-end late-stage pipeline review. This year, we expect the remaining Phase III data for amlitelimab in AD and Phase II for lunsekimig in asthma and rare disease with venglustat Phase III readouts, if positive regulatory submissions will follow.
We anticipate multiple regulatory submissions based on data we already received last and this year as well as regulatory decisions for medicines and vaccines under review. Next year, we will get the Phase IIb data for brivekimig in HS, followed by Phase III studies of frexalimab in RMS and riliprubart in CIDP. My sincere thanks to all Sanofi R&D colleagues who share my commitment to advancing our pipeline from research to regulatory approval. This represents a rich diversified news flow that we believe will continue to drive value creation for patients, society and of course, for Sanofi.
分析師問答
The first question is from Zain Ebrahim from JPMorgan. Zain?
Zain Ebrahim, JPMorgan. My first question is on the Dupixent rollouts in CSU and COPD, which sound like they've been particularly strong. But can you elaborate on how those rollouts are progressing and remind us of the biologic penetration in each of these indications and how Dupixent is faring against competition from RHAPSIDO in CSU and NUCALA in COPD? That's my first question. And my second question is a vaccines question. Just in terms of within your overall vaccines guidance, what you're assuming for Beyfortus in '26 in terms of growth and how that looks for the U.S. versus ex U.S.?
Okay. Thanks, Zain. Brian, Dupixent?
Thank you, Zain so much for the question. So I'll go a bit broader and then I'll focus in on a couple of those indications. So as you look at our performance in 2025, really strong performance, 25% growth year-over-year, and we culminated that with a really strong Q4, and I'll talk about that here in a minute, 32%. Now this was driven not just based on those 2 indications that you highlighted, but the foundation of our indications grew as well because it's a volume-driven growth story that we saw in 2025. Now of course, those were on our base indications, but the launch of COPD, the launch of CSU and the launch of BP were new sources of growth that were not in our base in 2024, which allowed us to accelerate growth, culminating in that Q4 that I talked about there just a bit. And again, I'll highlight COPD and CSU in just a minute. But that 32% growth that we saw at the end of the year is really a reflection of those not being in our base, but being strongly in Q4 performance that we saw.
Now as we go forward into 2026, we expect that growth to normalize as we talked about, as we've seen before, and we're well on track to deliver our longer-term guidance by 2030 of around $22 billion sales. Now specifically on COPD and CSU, I've spoken about COPD quite a lot. It was an inflection point for this year, as you can see from the performance, which was, again, being the first biologic, really the first innovative therapy in more than 10 years in the COPD space, and we've seen a really good response from the physicians. Now remember, we were already in the pulmonologist offices with asthma and having the leading asthma therapy beforehand. So it was a really nice complement. CSU is a very similar story. We've seen a really rapid uptake in the CSU launch. But again, remember, we were also already the leader in the dermatologist offices and the allergist offices with multiple indications, now 8 indications in the U.S. So we've seen that those have contributed really nicely to our growth.
Final point I'll make on CSU because you asked a question about the competitors, RHAPSIDO. We don't really zoom in on one. We think competitors across all the immunology indications are really good because the bio penetration rates are extremely low. AD is only 18% still to date, and it's more than 8 years into our launch. CSU, we believe, is in the low teens. So again, this is a place where you're going to continue to see the market growth as well, which is great when we have new competitors come in.
Okay. Thomas?
Thank you, Zain, for the question. Regarding Beyfortus, we are pleased with the performance in 2025, showing an increase of just over 9% year-on-year. We had earlier indicated modest growth expectations for that year, so we’re encouraged by this outcome. This growth is attributed to our expanding reach, as Beyfortus is now available in over 45 countries. Looking ahead to 2026, it's still early to provide specific performance expectations, but I want to highlight the differing dynamics between the U.S. and non-U.S. markets. In the U.S., recent changes to the pediatric immunization schedule have occurred, but there have been no changes in recommendations or coverage for Beyfortus. It remains to be seen whether this will cause any confusion for parents and healthcare providers. We’ll know more in the coming months and will provide further updates during the Q2 earnings call. As for international markets, we plan to continue expanding our geographic reach as we have in the past two years. Lastly, I’d like to mention a recent JAMA publication from the end of December 2025 that features the first real-world evidence comparing maternal immunization with Beyfortus to passive immunization. The findings show that Beyfortus outperforms the competitor across all endpoints. Thank you very much.
Thank you for that, Thomas.
Next question is from Ben Jackson from Jefferies. Ben?
Brilliant. Just 2 for me, please. I guess, previously, you've spoken about a range or numbers of peak sales estimates around amlitelimab. And perhaps now that we've had some additional data, has your view on any of this changed at all? And Houman, perhaps if you could flesh that out. And you've had a little bit of time to talk to KOLs now and figure out how they're feeling. What is the feedback that you're getting on the additional results, not just kind of the positive parts on it, too, but if I can push you, what are the pinch points? What are the bits that they still got a little bit of uncertainty or questions over as well? And how can you address those? So just rounding that up would be brilliant.
Thanks, Ben. Brian, do you want to give us a broad view?
Yes. Thank you for the question, Ben. From a broad perspective, we've always been optimistic about this from an AD viewpoint, and I believe Houman will elaborate on that. The marketplace is still in development, and we've discussed the bio penetration, which I mentioned is at 18%. I am confident it will more than double. Looking at the success of psoriasis, this marketplace is set to keep expanding. As new mechanisms enter the market, as we've observed, it actually speeds up the growth of the market, similar to what we've seen with psoriasis. Introducing a new mechanism with various differentiation options reinforces our strong confidence in the opportunities within this large marketplace.
And Houman, do you want to...
Yes, to add to what Brian said, I want to emphasize the significance of a new mechanism in this field that extends beyond a simple anti-cytokine blockade. While that is an effective approach for the disease, incorporating a T cell modulator that offers the potential for long-term immune normalization is very appealing. You are correct in highlighting the need for a more data-driven approach. We've consistently demonstrated the advantages of this molecule with its Q4 and Q12 dosing options, allowing for a minimum of four injections per year after the loading dose. This not only gives patients flexibility but also relates to site of injection, which is important. Both the mechanism and the dosing options are crucial, but I want to stress that this molecule aligns with our initial benefit-risk assessment, which is critical in this area, as it remains significantly underexplored biologically. Brian mentioned at the start of the call how vital it is to have therapeutic options for these patients. Regarding your question about discussions with prescribers, we conducted hundreds of interviews over the last couple of years, including one at the recent meeting in Paris. I can confidently say there is enthusiasm surrounding this new mechanism of action in this space. Thank you for your question.
Thank you.
Next question is from Seamus Fernandez from Guggenheim. Seamus?
Let's try it again. There we go. So just a couple of questions. First, can you provide more detail on the Kaposi sarcoma case related to amlitelimab? Is this a mechanism issue, or is it more about the specific patient profile in that case? Also, I want to confirm that there have been no additional cases reported in the overall program for amlitelimab. The second question is about lunsekimig. Earlier this year, you mentioned that TSLP plays a role in some early atopic dermatitis data regarding lunsekimig. Could you clarify and confirm that comment and your thoughts on lunsekimig's potential role in that disease state?
Okay. Houman?
Yes. Thank you. Multiple parts to that question. Number one, let me do the second one first. Just to very quickly take that off the table. Yes, there is existing data, not with our molecule, but other people's molecules that TSLP may indeed have a therapeutic benefit in the treatment of atopic dermatitis. Obviously, IL-13 is well established in this space; the combination of TSLP and IL-13 indeed may have an additive or indeed synergistic effect. We are testing that clinical hypothesis; we will be very data-driven. So we look forward to seeing the results of lunsekimig, not only in asthma and its related adjacencies but also in atopic dermatitis. And then as you outlined in the amli question you composed to the sarcoma, the answer to your question is that all immunomodulators come with a theoretical risk of infectious complications or increased infectious risk. Kaposi's sarcoma unequivocally is caused by herpes virus, HHVA, sort of a standard herpes virus.
And it's not surprising that a herpes virus will be associated with an immunomodulator as they are with all other immunomodulators. There is some genetic evidence to suggest perhaps that with amlitelimab, there may be a differential sensitivity to some or other herpes viruses. So as you say, potentially on mechanism, and the very first ID that we put out before we ever started the Phase III as this was anticipated and was not regarded as a significant issue of concern. The benefit-risk profile with this molecule is in line with everything we've said. And as is our activity, we will continue to produce not just with Kaposi's sarcoma, but all the broader safety and benefit of this molecule as we continue to publish the data sequentially until the end of OCEANA studies.
Next question is from David Risinger from Leerink.
Congratulations on the fourth quarter performance. I have a couple of questions. First, Houman, regarding the amlitelimab press release you issued recently, when do you expect to disclose full results from those studies? And François, it seems that business EPS is set to grow slightly faster than sales this year, despite the loss of R&D reimbursement from Regeneron during the third quarter. Could you discuss the factors offsetting that? Additionally, as we look towards 2027, what are your thoughts on growth and earnings prospects?
Thanks, David. Houman?
Yes, a quick answer to your question. I think we committed to presenting the COAST 1 data at the end of March in Denver this year. Depending on the conference organizers, we may also be able to include COAST 2 and SHORE in that presentation. That's still under discussion. We hope to present most of the data to you by the end of March.
Okay. Thank you, François?
Yes, David, regarding 2026, we will see a decrease in R&D reimbursement from Regeneron of EUR 400 million this year. Initially, we expected it to be EUR 300 million, but due to the faster than anticipated growth of Dupixent, we will make this adjustment sooner. Although we face a negative impact of EUR 400 million this year, it will be more than compensated by Amvuttra royalties, which are projected to increase beyond our expectations. We generated nearly EUR 0.5 billion in Amvuttra royalties in 2025, and it is likely to reach around EUR 1 billion in 2026. Consequently, we anticipate a positive net impact of about EUR 100 million on BOI for 2026. For 2027, we initially expected the full effect of the termination of the R&D reimbursement to decrease BOI by about EUR 800 million, but it appears this will be slightly lower, around EUR 700 million, based on current observations. With regards to Amvuttra, we expect a further increase of about EUR 300 million. Therefore, the net impact for 2027 will likely result in a negative BOI of around EUR 400 million, which is an improvement from our previous estimates.
Next question from Simon Baker from Redburn.
Two if I may, please. Firstly, one for Houman. You've had a bit of a rationalization of your Phase II portfolio. I just wonder if you could talk us through any overarching principles that guided those decisions and future development plans? And then secondly, moving on to Dupixent. The main patent goes in March 31. But as far as we can tell, you've got about 40 patents which expire between late '31 and February 2045. So I just wonder if you could give us your thoughts on life after March 31 in terms of the potential LOE for Dupixent?
Okay. Houman we'll get you and then, of course, quickly to Roy for a moment.
Thank you for the question. When I started two and a half years ago, it was clear that we have a dynamic allocation strategy. We are responsible stewards of capital, and we must ensure that every dollar is spent wisely. The overarching strategy, which François and I collaborate on, involves regularly reallocating resources, now on a quarterly basis, guided by AI assessment of value. This means that some programs may be discontinued, but it also means we will invest more in certain programs and make the right decisions, even when they are challenging. The core principle relates capital allocation to value.
Thank you. Roy?
So Simon, thank you for your question. We expect Dupixent to remain protected by its patents in the U.S. beyond March 31. This is the reality. As you might expect, there is a lot of innovation and various indications being recognized through multiple patents for the years '31 to '45. We believe we have a robust patent portfolio that we plan to defend actively. While it’s too early to speculate on the specific timing of any biosimilar entries, if and when patent disputes arise, we will provide more details on what is being contested and where. Overall, we feel confident with our range of patents.
Okay. Thanks, Roy?
I wanted to ask on vaccines, please, because if we look at 2025, you deployed about EUR 3 billion on business development, M&A. So I wondered if you're putting that together with your R&D, is that a significant step-up in capital allocation to vaccines? And how should we think about the opportunity cost versus building your drug pipeline? And then perhaps a little more color on Dynavax. It looks like a neat deal. So how did you value it? Is this a U.S. opportunity mainly? Is it catch-up and then you move to an annual cohort eventually? And should we think about shingles as a booster opportunity in the over 70s?
Thank you, Luisa. Thomas, 2 good questions for you.
I will begin by addressing your question about Dynavax. To clarify, the transaction is still in progress and has not been finalized yet. Regarding the rationale behind this acquisition, there are several key points to mention. First, it aligns well with our previously discussed focus on the pediatric immunization schedule. However, we've observed a demographic shift with an increase in the older adult population and a decline in pediatric numbers, prompting our strategy to increasingly target the older adult group in our pipeline development. The proposed acquisition of Dynavax fits this strategy, particularly with HEPLISAV-B, which is primarily aimed at the U.S. market. This product stands out as it requires only two doses compared to three doses for competitors, and we believe our commercial capabilities can enhance its market performance. Additionally, you brought up the shingles candidate from Dynavax, which shows promising Phase I/II data.
There’s potential in this market if the candidate demonstrates efficacy comparable to existing treatments while offering better tolerability, which we believe is achievable through Dynavax's technology. Now, regarding capital allocation, you are correct that there’s been an increase planned for 2025. However, it's important to clarify that we assess capital allocation and acquisitions based on strategic fit rather than by therapeutic area. We evaluate whether each opportunity aligns with our portfolio, capabilities, and long-term business vision. We maintain a strong long-term outlook for the vaccination sector where the fundamentals are solid. Our recent acquisitions, both early and late stage in 2025, reflect this strategic perspective. We consider the strategic fit thoroughly, asking if we are the right owners and if we can add significant value, and if so, we proceed at the right price.
Yes, next question from Pete Verdult from BNP. Pete?
Yes, Pete Verdult from BNP. Apologies if some of these questions have already been addressed, but we've just wrapped up a lengthy competitor call. I have two questions. Thomas, I’d like to continue discussing vaccines. Can we explore the outlook based on the recent developments you mentioned, especially in the U.S., regarding the 10 billion target for 2030? I'm looking for a general reminder of what percentage of your business is currently affected by the changes in the U.S. pediatric vaccination schedule. While we don't expect any immediate impact, could you provide an overview of the exposure? Additionally, can you elaborate on the dynamics of Beyfortus in the U.S. and outside the U.S.? As for flu, what is your perspective on the outlook? On one hand, the threats from mRNA are diminishing, but there are rising investor concerns about risks from competing preventive treatments. How do you feel about the flu situation overall? As for my second question, could Paul or François address capital allocation? Given the recent disappointments in the pipeline, should we expect a significant increase in business development activities moving forward? While I know you can't discuss specific assets, can you share your intentions regarding business development in general?
Okay. Thank you. Thomas and François?
Yes, welcome, Pete. There was a similar question earlier, so I’ll keep this brief. Regarding the outlook on vaccines, you’re referring to the recent changes in the U.S. childhood immunization recommendations. These recommendations have been crucial in preventing life-threatening diseases among U.S. citizens for many years. The recent shift to a 3-tier childhood vaccination framework has caused confusion for parents and providers. It’s too early to determine if this will have a concrete impact this year. However, I want to highlight a couple of points: first, most medical societies and healthcare professionals have decided to stick to the previous immunization schedule. Second, all vaccines are still covered by insurance, Medicaid, or Medicare, depending on the product, so coverage is not an issue. There may be some confusion regarding the U.S. vaccination schedule, but we are focusing on what we can control.
We are actively engaging with healthcare professionals and clinical societies worldwide to promote the benefits of our products and how they stand out from the competition. Regarding Beyfortus, we are pleased with the 9.5% increase in 2025 performance and will provide more guidance for 2026 later in the year, likely during the Q3 earnings call, where we will compare U.S. to ex-U.S. performance. On flu, we observed significant Q4 performance, with a substantial rise in influenza hospitalizations in the northern hemisphere for two consecutive winters, highlighting the importance of vaccination. Our market share is expected to grow in 2025, driven by our differentiated products like Fluzone High-Dose and Flublok, which have demonstrated strong clinical data. Although the U.S. experienced a decrease in vaccine coverage rates, and Europe saw a slight increase, these markets are very different from a value perspective.
We’ll provide more guidance on flu during the Q2 earnings call. We are not concerned about mRNA for flu in 2026 or 2027, as we believe we are well positioned with the right products, and we expect to have more updates after the pre-booking season, around the Q2 earnings call.
Thank you, Thomas. François?
Yes, Pete, on the capital allocation question, well, first and foremost, I presented it earlier, we have a strong balance sheet that gives us flexibility. That being said, we will remain very disciplined. So we will use our capital essentially around 3 criteria in terms of external growth, BD and M&A. Strategic, essentially around our 4 existing main therapeutic areas plus potentially some white spaces. We want to make sure that we bring scientific differentiation with best-in-class, first-in-class assets and differentiated assets, and we want to secure financial return as well. We are certainly not chasing growth for the short term and medium term. You saw our growth profile last year. You see our growth profile for 2026, which is at the upper end of the industry. So not chasing growth. But we are rather focusing on the longer term to complement our pipeline. So we have a certain number of assets in our pipeline.
We know, as we discussed a few minutes ago, to manage the LOE of Dupixent at the earliest in 2031, we just discussed it. So as a consequence of that, we will try to focus essentially on Phase I, Phase II assets, which is our priority. We could as well, as we did last year, complement it with commercialized assets, which will probably, to a certain extent, mitigate the BOI/EPS impact. Anyway, we will remain very disciplined. And I would not say we have time because time flies, and we have a feeling of urgency. But once again, we will be super focused and super disciplined.
The next question is from Steve Scala from TD Cowen. Steve?
Two questions, please. First, I'm curious why Sanofi has not been as forthcoming as Regeneron on Dupixent life cycle extension programs. I'm referring specifically to what Regeneron shared earlier this month. My understanding is that you have similar rights as you do now. So are you simply not as confident in those programs? So that's the first question. Second question is, in the past quarters, Sanofi has noted on the Dupixent slide that Dupixent was #1 in new-to-brand Rx and #1 in total brand share in the U.S. Curious why that was left off this quarter. Is that due to competition, specifically from Ebglyss?
Okay. Brian, 2 questions for you.
I'll start with the second question. Thank you for the setup. We are still the top performer in every area across all our specialists. I apologize for not including that on the slide. I don’t anticipate any changes in that regard. Regarding LCM and what’s upcoming from a Regeneron perspective, I’ll expand on what Roy mentioned. It begins with our intellectual property, and we need to think about how to protect that in the long term. Roy made a statement about our timeline, and we have quite a bit of time ahead. We've been advancing alongside our alliance and LCM strategy, as expected, and will share updates in due course. Most likely, you'll hear about our progress on Dupixent in the first half of this year, possibly related to formulation developments. Additionally, we are collaborating on the next-generation IL-4Ra with Regeneron. They shared some information on this at JPMorgan, and we continue to work together on programs within the alliance. This could lead to significant future offerings following Dupixent. Given our longstanding success with the alliance, we remain open to exploring future collaborations with Regeneron, as mentioned at JPMorgan. I believe we are in a strong position and will have more updates soon.
Yes. Next question from Sachin Jain from BofA.
Just 2 questions from me. Firstly, big picture, I guess, for Paul. There's a sentence in the press release that talked about midterm profitable growth for 5 years. And at a recent conference, you talked about potentially delivering, I guess, implied with teens EPS. So just a big picture from your side. What was the intent on that signaling and giving you consensus as large as their ex pipeline? So just thoughts as to inserting that commentary within the debate for investors. And then secondly, one for Houman. Do we get any further TL1A Phase II data through the course of '26 that further profiles the asset as we start looking to that Phase III data, I guess, into '28?
I should maybe let François comment first on profitable growth.
Yes, profitable growth. I think that we included that comment in the press release because we had a lot of questions. We just wanted to make sure that the market understands that we do expect to deliver an attractive level of growth to start with for the next 6 potentially years and that this will be coming with profitable growth as well because there was a question a couple of quarters ago about our capacity to deliver profitable growth each and every single year. I confirmed it a little bit earlier today. There was a question more specifically about '27 given the end of the R&D reimbursement with Regeneron, but it's not a defensive move; it's just a confirmation of the way that we see the outlook for the medium term.
And your second question, the answer is simply, yes. We will have maintenance data for the TL1A at some point this half.
Next question from James Gordon from Barclays. James?
One question was about business development. I understand you’ve already addressed some queries on this, but I have a follow-up. There were comments this morning regarding the company’s business development capacity being between EUR 14 billion and EUR 15 billion for this year. Assuming that is correct, what is your strategy? Are you looking to leverage immunology to acquire more assets that could complement developments from Dupixent? Given the competitive landscape in immunology and your current engagements, might you consider expanding into other areas of your business? Could this EUR 15 billion be allocated towards one significant deal, or is it more likely that you will continue to pursue immunology, or potentially diversify? Additionally, regarding AAT, I noticed there hasn’t been an update on regulatory plans. Have you communicated with the FDA? If not, when do you anticipate doing so, and do you believe you can submit a filing based on the data you currently have?
Why don't we get François, then...
No, I will just answer on the EUR 15 billion, which I would say is the upper limit of what we can do to maintain our AA rating. So it has nothing to do with where we can invest by TA and so forth. As I mentioned, we are fundamentally interested in strengthening our position in our four existing therapeutic areas plus potentially exploring new opportunities. We could always consider going beyond that. But the EUR 15 billion was the technical limitation to preserve our AA rating.
Thank you. Houman?
Yes. I'll follow Brian's lead. Thank you for the question. We had excellent data, as we announced late last year. We'll imminently, certainly, this half of the year, go to the FDA to have broader conversations on the trajectory of that molecule as we previously suggested.
Okay. I think was the final question, was it? Or there's next question?
Yes, next question from James Quigley from Goldman Sachs.
I've got two questions, please. Hopefully, they haven't already been asked, but I'll give it a go anyway. First, following up on Steve's question regarding the Regeneron portfolio. The IL-13 assets were not included in the alliance. Was that a decision made by Sanofi? Do you believe lunsekimig is a more attractive option for IL-13? Can you share any insights on why you are excited about the IL-13 and TSLP combination for lunsekimig? Secondly, regarding the hemophilia portfolio, ALTUVIIIO continues to show strong growth. What are your expectations for gaining additional market share through 2026? Are you prepared to provide a peak sales forecast now that you have achieved blockbuster status? Additionally, for Qfitlia, the launch is progressing steadily, and you've received approval in China. What has the feedback been regarding where Qfitlia is being utilized? Are there any lingering concerns about thrombosis with the product that could be hindering its progress?
Okay. Thank you so much. Okay, Brian, over to you.
Yes, James, thank you for the question. I touched on this briefly earlier. There hasn't been a decision regarding IL-13. We discussed this at JPMorgan recently. We're not currently including it in the alliance, but we're always open to discussing it with Regeneron about possibly incorporating it. Additionally, we have a long-acting IL-4 RA in the alliance that we are actively developing as a follow-on to Dupilumab. We value our strong partnership with Regeneron and will continue to talk about future collaborations. Regarding Qfitlia, it's still early in the launch phase. From the start, we've said this is an innovative therapy as it is a targeted precision medicine based on antithrombin levels. We've anticipated a slower ramp-up, but it should have strong long-term engagement from patients as doctors can adjust the treatment according to each patient’s needs. So far, we’ve received positive feedback from the market and no safety concerns. However, it’s still early and looks promising. We will keep you updated in future calls.
Okay. Thank you, Brian. And then I think there may be one more?
Yes, one more question and last question from Graham Parry from Citi. Graham?
Apologies if it has been asked, I think it has. I just wanted to check on itepekimab. You're saying about looking at additional data for the path forward. So can you give us timelines on what it is you're looking on the data and the clarity and timelines on path forward for that molecule? And then tolebrutinib in the U.S., are we just correct to assume no path forward in the U.S.? If you could just comment on rest of world regulators' attitudes to the ability to monitor compared to the U.S., that would be very useful.
Graham at Citi, and those that will know, no, I have made that point. Thank you for the question. The first question, let me do it in reverse, tolebrutinib's approach is pretty straightforward. We're waiting for regulatory comments from rest of the world, as you say from EU. And we'll see where we take it from there. And then on itepekimab, as I consistently said, the next steps for itepekimab will be determined by interactions with the FDA predominantly to establish exactly the requirements for a replication study for Phase III going forward. As soon as we know, we will commit to sharing it more broadly in partnership with our successful alliance partners Regeneron.
Okay. Thank you, Houman. Thank you, Graham. Well, thanks for this last question. In 2025, we achieved a strong year of profitable growth. Sales increased by 9.9% at constant exchange rates, while business EPS improved significantly faster by 15%. We launched 3 new medicines and vaccines: Qfitlia, Wayrilz, and Nuvaxovid. All this was made possible by the dedicated effort of all Sanofi colleagues worldwide. In 2026, we expect sales to grow by a high single-digit percentage and business EPS to grow slightly faster than sales. We anticipate profitable growth to continue over at least 5 years. Based on our pipeline combined with external growth opportunities, our ambition is to pursue earnings growth into the next decade. With this, I would like to thank you for the interest in Sanofi, and we'll now close the call. Thank you.