管理層發言
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 #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 Q2 2025, unless stated otherwise. Please turn to Slide #4.
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 1 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 2 options in Zoom: Raise Your Hand or submit your question using the Q&A function. With this, I'll hand you over to Paul.
Well, thank you, and hello, everyone on the call. We'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 6. In Q2, our launch has generated close to EUR 1 billion in sales, continuing the momentum we saw in Q1. ALTUVIIIO 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.
Qfitlia, 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 9 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 improved indications across geographies. Momentum has been driven by the market growth across all indications where biopenetration 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 2 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 a 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 6 months in the EU label of Beyfortus. And 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 9, the completion of the Blueprint Medicines acquisition just 2 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 USD 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 addition of Blueprint brings an established presence amongst allergists, dermatologists, and immunologists, enhancing our ability to advance our own pipeline in immunology. With the acquisition now completed, I would like to formally welcome the talented teams of Blueprint to Sanofi. Together, we look forward to the potential of 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 #1 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.
Thank you, Paul, and hello everyone. As mentioned earlier, net sales rose by 10.1% at constant exchange rates in Q2. This growth was mainly driven by Immunology, our pharmaceutical launches, and Beyfortus. Gross margin improved by 1.5 percentage points, primarily due to a better product mix and increased efficiencies. R&D expenses went up by 17.7% from a lower base last year, which included a one-time reimbursement from Sobi. Underlying R&D expenses, excluding this reimbursement, rose by about 7%. We anticipate moderate growth in R&D expenses for the second half of the year. Business EPS reached EUR 1.59, an increase of 8.3%, reflecting our strong sales performance and improved gross margin. Looking beyond Q2, in H1, SG&A grew at about half the rate of our sales increase, with 70% of the SG&A increase allocated to sales and marketing investments to support our current growth and future launches.
Business EPS for the first six months is up 12%, fully supporting our expected strong EPS recovery for the entire year of 2025. In Q2, we continued to follow our capital allocation priorities after receiving around EUR 11 billion from the sale of a controlling stake in Opella in April. We have been actively reinvesting this capital, announcing acquisitions of Dren Bio's DR-0201, Vigil Neuroscience, Blueprint, and more recently, Vicebio. These acquisitions align perfectly with our strategy and meet our three main criteria: strategic fit within our core therapeutic areas, scientific relevance with differentiated medicines and vaccines, and financial attractiveness. Three of our four acquisitions reflect our interest in early-stage assets. Although Blueprint is at the upper end of our price target, we believe in its strategic value in rare diseases and immunology and are confident in its future financial returns.
As previously mentioned, early-stage opportunities remain our focus, but we remain flexible to expand slightly when attractive business cases arise. Looking ahead, we still have capacity for business development through M&A while maintaining our AA credit rating. Additionally, we are executing our EUR 5 billion share buyback program for 2025, with more than 80% already completed as of today. We are committed to finishing the full program by the end of this year. I would like to highlight two key aspects of our ongoing financial performance: the Regeneron development balance and the Amvuttra royalties. Profit-sharing payments to Regeneron are increasing in direct relation to Dupixent profit growth, partially offset by the development balance compensation we receive from Regeneron. Historically, Sanofi has funded a larger share of Dupixent development costs compared to our partner. Under our agreement, Regeneron reimburses up to 50% of these cumulative costs by deducting them from our profit-sharing payments.
Based on current forecasts, we expect the development balance to be fully reimbursed by the end of 2026, leading to a projected negative year-on-year BOI impact for Sanofi of around EUR 300 million in 2026 and a more significant impact of approximately EUR 800 million in 2027. From 2027 onwards, R&D costs will be shared within the same year. Additionally, new royalty streams are becoming increasingly important for margins. For instance, Amvuttra was recently approved for a new indication in both the U.S. and EU, with royalty rights up to 30% of sales. The projected royalty revenue from this medicine, based on external consensus, is expected to significantly contribute to our financial outlook, likely until the end of the decade. Regarding the remainder of the year, Beyfortus showed strong momentum in 2024, achieving high vaccine coverage rates in several markets. We predict modest growth for 2025, with Q4 sales expected to be similar to Q3.
In the flu segment, while we anticipate gaining market share, total sales are expected to decline by a mid-teens percentage compared to last year due to competitive pressures, particularly in the U.S. and Germany. We foresee a sales distribution of about 75% in Q3 and 25% in Q4. For the full year of 2025, operating expenses may rise slightly due to the previously announced acquisitions. The foreign exchange impact is now estimated to be around minus 4% on sales and about minus 6% on EPS. Other projections are consistent with what we shared last quarter. For the entire year of 2025, we now expect sales growth at a high single-digit percentage, at the upper end of our previous guidance. This revision of our sales guidance is not related to Blueprint, which will be consolidated from mid-July 2025, but to the underlying performance of our business. We maintain our EPS guidance of low double-digit percentage growth at constant exchange rates, which reflects an upgrade of our EPS guidance as we now consider several hundred million in additional costs from our newly acquired businesses, primarily in R&D. Finally, we are navigating a dynamic environment filled with uncertainties, including potential U.S. tariffs on EU exports. However, since many details remain limited and unsettled, we will keep you updated as developments arise.
Thank you, François. Since our last update, we received U.S. approval for Dupixent in bullous pemphigoid and MenQuadfi 6 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 Cerezyme in the U.S. for Gaucher disease type 3, with an FDA decision expected in January next year. Despite itepekimab's mixed Phase III results, our pipeline continues to advance, with new rabies vaccine showing consistent Phase III efficacy. We secured 7 new regulatory designations, including orphan and fast track, and had 7 medicines featured in prestigious journals, which emphasizes our determination to accelerate our commitment in improving R&D. Last quarter, as François said, we acquired DR-201 from Dren Bio, now entering Phase I in immunology. We have since made 2 acquisitions: Blueprint with Ayvakit and 2 new potential options in mid-stage clinical development, the potential next-generation molecule elenestinib for mastocytosis and BLU-808 in inflammatory indications.
And lastly, Vigil with VG-3927, 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 the new monoclonal antibody from multiple myeloma, which was recently designated an orphan drug, showcasing our ongoing innovation from our own research in France. Externally, we continue to augment partnerships and collaborations, working hand in hand with the leaders in the field to bring cutting-edge treatment to patients. Next slide. We're committed to addressing the large unmet medical need for different COPD patients with Dupixent, with itepekimab, and, lastly, with lunsekimig. At ATS, we presented pooled data from BOREAS and NOTUS Phase III studies, showing significant reductions in exacerbations, FEV1 improvement, and quality of life, confirming our legacy in COPD with Dupixent.
For itepekimab targeting former smokers, we're progressing with the data analysis for AERIFY-1 and AERIFY-2 Phase III studies, including insights from other molecules targeting the same pathway. And once more advanced, we will discuss with regulatory authorities and provide an update on next steps. The data will be presented at an upcoming medical meeting. Lastly, we announced our intention to evaluate lunsekimig, our IL-13-TSLP pentavalent antibody in a Phase II/III COPD study this year. Based on its benefits seen in existing clinical studies and 2 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 Ib data showed a 40.9% ppb reduction in FeNO levels in asthma with patients at day 29. The medicine remains our main interest in respiratory conditions, thanks to its effect on biomarkers and symptoms.
Next slide. Rilzabrutinib has emerged as a safe and highly effective platform for rare diseases. The regulatory decision is expected soon for ITP with a target action date for the FDA decision on August 29, 2025. It's received its first global approval recently in the UAE. Moreover, we are pleased by the recent designations received, a fast track for IgG4 disease and orphan drug for wAIHA 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 3 studies, evaluating the convertibility of Sarclisa administered either by both on-body injector or manual infusions compared to IV results for the study across different lines and regimens, which demonstrated noninferiority, with most of the patients preferring the on-body injector. Regulatory submissions are underway, with acceptances expected soon.
Finally, efdoralprin alfa, our recombinant human AAT-1 fusion protein in a Phase II superiority study for alpha-1 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 ALTUVIIIO and, lastly, fitusiran. Based on the 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. Riliprubart, 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 or remained stable on riliprubart at 24 weeks. Results from Part B confirmed findings across all CIDP patient substrains, 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 a 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 in the U.S. for AMR. Our Phase III programs include 2 studies. MOBILIZE is 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 in 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 2 halves. Key upcoming studies include the Phase II efdoralprin alfa in AATD and DOTAMTATE with Orano Med and 2 significant Phase III readouts with tolebrutinib 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 seeks 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 4 injections a year, potentially in the maintenance setting.
As a reminder, recent results in asthma provided support for longer dosing intervals 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 it's the nature of drug development, we're confident our skilled 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 continue chasing the miracle of science to improve the lives of patients. With this, I will hand back to Paul.
We will now open the call to questions. Please limit your questions to 1 or 2. Let's take the first question. Please proceed.
分析師問答
So I wanted to touch on the R&D transformation because we see enormous amounts of progress at Sanofi across the whole organization, but the share price is still lagging. And I think it's awaiting pipeline progress. So on the R&D transformation, I wanted to check your levels of confidence given some of your recent successes but also some more mixed data sets, which are still in-house. And if we go back to your December '23 R&D Day where you laid out some objectives, you were targeting a 50% increase in Phase 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 3 of those could be over EUR 5 billion. So 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? And if so, has the mix changed now that you have more data in-house?
Thank you, Luisa, very comprehensive. Houman, do you want to get started?
Thank you for the question, Luisa. I will keep it brief. Sanofi has shifted to an R&D-focused approach, emphasizing innovation for patient care, and I am encouraged by this transformation. However, we must recognize that such a change takes time, often around 5 to 7 years according to industry standards, and I believe we are well on our way. The results will speak for themselves, and we maintain a humble perspective regarding the challenges posed by diseases. To directly address your question, of the three major projects we discussed on December 7, 2023, amlitelimab was one, alongside frexa and balinatunfib. We are dedicated to all the candidates in our portfolio, and amlitelimab is expected to report results from its first Phase III trial soon. We are eager to validate our forecasts. I will now turn it over to Paul.
Yes. I mean, Luisa, and I think it's fair to say, we had plenty of time to reflect on the ups and downs of this year. And 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 and crossed every t on the studies to make sure that we will continue to push science, as expected of us. What we would like to avoid is stubbing our own toe. So we have some work to do. I think we remain, on balance, optimistic about the nature of the big 12 and what that could mean for us. Of course, not everything will work. I'm very pleased with how the transformation has progressed.
But I think you're right, by the way, that is, for some, the jury remains out that the progress is one thing, but it's revealing itself in successful Phase IIIs. And 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 lessons about being patient. So we have to do good work, be diligent, be accurate and factual. And then we just have to turn the cards over, and we recognize that we're better just to keep our powder dry, get the results, share them, and confidence will be built from there.
First question, regarding the increase in spending, which was higher in the first half for both SG&A and OpEx ahead of new launches, how should we anticipate this developing, particularly with '26 in mind? You might have some notable launches towards the end of that year and into '27. Should we expect SG&A and R&D to continue to rise from here? Have we reached a certain level, or with the new trials you're initiating, should we expect both that and Blueprint to increase as well? Additionally, how should we consider the margin in '26? Will it be similar to '25? Also, on Dupixent, there seems to be some weakness in China. We've noted this with some products that have NRDL listings and some market pressure there. Can you share your thoughts on China, Dupixent, and the rest of the portfolio, and how we should view growth moving forward?
No, Richard, it's a good question. François speaking. On R&D, we reported a 17% increase in the quarter. However, if we exclude the exceptional revenue we had from Sobi last year, the underlying growth is 7%. As I mentioned earlier, we expect R&D to be around flat, possibly slightly up in the latter part of the year, so for the full year, we will be where we anticipated, with a slight increase. There may be some additional costs from Blueprint, but we still plan to meet our initial guidance from the beginning of the year. There is a bit of phasing between the first and second half of the year, but I have no concerns. On SG&A, there is also an increase. To provide some context, our SG&A increase is half of our sales growth, which indicates we are benefiting from growth leverage. We expect this trend to continue. Notably, 70% of the increase in the first half was invested in sales and marketing to drive growth and prepare for future launches, which I consider a healthy position for investment.
While I won't provide guidance for '26 because it's too early, I can say that we expect to see an attractive growth profile until at least 2031, with tight cost control resulting in G&A being roughly flat. Sales and marketing will increase but likely at a lower rate than sales, and R&D will be slightly up as well. However, it will depend on readouts and may be influenced by some acquisitions in business development and M&A, so we lack full visibility on year-to-year projections at this point. Regardless, we anticipate growth leverage will help us see an increase in BOI in absolute terms over the coming years, primarily due to strong sales growth, tight cost control, and growth leverage. We expect to achieve this in '25 and in subsequent years, allowing us to manage specific items like the Regeneron end of R&D reimbursement within our BOI. Therefore, we do expect our BOI to increase annually, and I am very confident about that.
Thank you, François. I believe we have an attractive growth profile with tight management on operating expenses and research and development being generally stable, depending on our successes in R&D, which are projected to increase this year and slightly beyond. We'll see how it turns out. Additionally, we have one of the lowest genericization profiles among companies for the next several years. It's crucial that we advance the medicines that contribute to our growth and fund their launches. We've made significant progress as a team in reshaping the business, but we must be very careful with how we allocate those investments since we aim for increasingly profitable growth. It's quite clear. Brian, regarding Dupixent in China.
Well, thank you, Richard, so much for the question. And I'll come to China in just a second. As you probably know, Dupixent is a pretty diversified product now around the world, a bunch of different indications. So we're in 8, as Paul alluded to already in the United States. And so while China is a very important marketplace, it is one of many where we're actually seeing continued underlying volume growth. And so I'd first start there. Actually, in China, we've seen more than 30% volume growth in China. So really positive in China right now. Of course, as you mentioned, we will have pricing pressures from time to time in market as is normally the case and as we planned for. And we will grow through the NRDL actually eventually. But as we get more access to more indications in China, this is going to be a really important marketplace for us moving forward, but one of many.
I have two questions. First, regarding amlitelimab, if I am a leading prescriber for atopic dermatitis, what do you think I want to see from amlitelimab? Am I looking for greater efficacy than dupilumab, or do I want efficacy that surpasses dupilumab in specific subgroups? Or is my primary interest in achieving the same level of efficacy as dupilumab but with an improved duration of treatment? Secondly, I have a finance-related question about tariffs. I recall there were many uncertainties mentioned. Have you incorporated any assumptions into your guidance for 2025, or are you relying on the basic levels discussed in the current EU-U.S. trade agreement? Alternatively, have you moved enough inventory that it doesn't have an impact this year?
Let's start there, François.
Yes, it's challenging to comment on uncertainties. However, we have explored various scenarios. Based on what is currently reported in the media, we have assessed the potential impact on 2025, especially since we're already further along in the year. We can confirm that we did not include this in our guidance, but it will have a minor effect on 2025 because we already have inventory available in the U.S. Therefore, considering what we know today and what we've seen in the media, we do not expect it to affect our guidance for 2025.
Thank you for the question. I believe it's important to consider the atopic dermatitis landscape. It concerns me that only 15% or 16% of biologically eligible patients are currently receiving therapies, including our own products and those from other companies. We are open to new treatments in this area, and I think key opinion leaders will also appreciate having more options for their patients. Specifically regarding amlitelimab, we recognize the diverse patient population that requires a range of solutions. For instance, patients who do not respond to current treatments show increased levels of OX40 ligand in their skin biopsies. This leads us to believe that a new treatment, consistent with our published STREAM-AD work, offering longer intervals and comparable efficacy to the standard of care, would be highly valued in the market. Additionally, newer treatments with significantly lower efficacy than the standard have already attracted a lot of attention. Therefore, a comparable molecule that also extends treatment intervals would be of considerable importance.
Yes. I think if you look at the STREAM-AD design, we had another opportunity to explore longer treatment intervals. We are eager to see what that could potentially look like. The data will guide us.
Can you hear me?
Yes.
I have a question about the flu. You indicated a mid-teen decline mainly due to pricing pressures. Could you elaborate on how Sanofi intends to address this aggressive pricing situation in various markets? Also, what are your thoughts on the long-term pricing environment for flu? Additionally, how do you perceive RFK Jr.'s leadership impact on the flu business in the U.S. so far? Furthermore, you forecast high single-digit growth for the top line, despite the slow headwinds that have been present. This seems to indicate a resilient business regarding revenue. Can you explain your confidence in reaching that upper target? Which franchise do you anticipate will drive performance in the second quarter? Any insights would be helpful.
Thank you for your question, Shirley. Regarding the second part of your first question, I don't have specific comments on the new administration's view on flu. However, I can share some insights on our expectations for the full flu year in 2025. We anticipate a mid-teens percentage decrease in our sales for that year, with a Q3 to Q4 split of 75% to 25%. This is primarily due to competitive pricing pressures. In addition, there is a one-time impact in Germany, where the flu recommendations for the elderly include a new adjuvanted competitor, resulting in prices dropping to about half of what they were the previous year. This effect will not repeat beyond 2025. The overall decrease is also linked to competitive pricing pressure, mainly in the U.S. and somewhat in international markets. It's important to note that we are a significant leader in the flu market, and we expect to maintain a strong market share despite the overall decline in market value.
Our solid performance in the flu market is supported by our differentiated portfolio, which includes Fluzone High-Dose and Flublok. Looking at the long term, our strategy aligns with our vision, which is why we partnered with Novavax and Nuvaxovid. We foresee the market evolving towards more differentiated flu vaccines like ours that provide strong efficacy and good safety profiles. Additionally, we expect a shift towards flu-COVID-19 combination vaccines that will also maintain high efficacy and tolerability. With our flu-COVID-19 portfolio in development, we believe we have a strong chance of succeeding in this area.
Yes. And Shirley, on the question about landing in terms of sales growth for the full year, indeed, we confirm our confidence for the high single-digit level for the full year. First and foremost, we did 9.9% in H1. It does help for the full year. Second, we will continue to have a strong growth with Dupixent. Don't forget that we were at 21% of value growth in Q2. It's amazing. By the way, it's even in the mid-20s by volume 8 years after the launch, really impressive. It's not only Dupixent. We are not Dupixent dependent. Launches, they contributed 10% of sales, but they also contributed, in Q2, almost 1/4 of our growth and is gaining traction quarter after quarter. And we have a resilient Gen Med business. Our established products are very resilient as well. So we do confirm our high single-digit guidance for the full year. Let's be careful with Q3. We have flagged it already since the beginning of the year. We had very high 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. So it's not coming from Blueprint. high single digit, it's coming from the base business.
First, regarding Dupixent, could you provide more details on the ramp-up in COPD now that the product is available in certain countries and additional ones are on the way? Where do you see the best adoption for this disease? My second question is for Paul about M&A. With the recent Blueprint acquisition and late-stage products, is it reasonable to expect that in the future you will look for earlier-phase assets and transactions that are more in line with what you previously referred to as bolt-on, around EUR 2 billion to EUR 5 billion? Any insights on that would be appreciated.
Thank you for your question. The double-digit growth we’ve experienced comes from various indications and geographies. Our core business, particularly in atopic dermatitis, asthma, and nasal polyps, continues to see strong growth. It's also exciting to witness growth from new indications such as COPD, CSU, and recently, BP. Regarding COPD, about nine months post-launch, we are still seeing enthusiasm from customers, primarily pulmonologists who previously had extensive experience with Dupixent for asthma. If we analyze the pulmonology community, we can see that prescription volumes have significantly increased in pulmonology offices, aided by the COPD launch alongside asthma. This is very encouraging and will continue to progress over time. The start of the COPD launch has been very positive, and we are consistently seeing this across different markets, with 13 already and 6 more set to launch before the year's end.
Thank you, Brian. We've been indicating for some time that we are targeting a range of EUR 2 billion to EUR 5 billion. For the past year or two, we have mentioned our willingness to consider opportunities outside this range, but we prefer to stay in the single-digit range. The Blueprint opportunity aligned perfectly with our focus on immunology and rare diseases. We believe we are uniquely equipped to build upon the excellent work of the Blueprint team and to act swiftly thanks to our experience as a leading company in rare diseases. It's important to note that this is still in the launch phase. Additionally, we have elenestinib and potentially a more complex but promising option with 808 coming later, which could be transformative. Naturally, there's a risk these projects may not succeed, but they align well with our strategic goals. Regarding future deals, while it's true we just completed the Blueprint acquisition, we plan to return to the EUR 2 billion to EUR 5 billion range, not due to financial constraints, but because we want to focus on early-stage opportunities, which typically fall within that range.
We aim to maintain our AA rating and preserve our financial flexibility. As François mentioned, our growth outlook for the next five years is among the best in the industry. Our focus remains on early-stage investments in areas where we have strengths and where the additional cost to deploy new assets is reasonable. It's essential for us to keep building our portfolio as we approach the early 2030s, when we need to be ready for launches. We're committed to being disciplined in our approach, dedicating significant time to this process and being selective about the opportunities we pursue. Overall, we are pleased with our current position.
A couple of product ones and then one clarification for me. So on amlitelimab, the answer to the prior question, you flagged the importance of less frequent dosing. We haven't seen, I don't think, in the Q12-week asthma data. So just any color you can give on 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 tolebrutinib in SPMS. As you approach approval, just what should our expectation for the REMS be? And how that might impact launch? And then just a quick clarification on a prior question on the BOI for '26, '27. So in no doubt, should we see BOI margin growth as well as absolute growth? I heard the answer as a comment on absolute BOI, and I think the question was on the margin.
Thank you for the question, Sachin. To clarify on amli, when I mentioned the longer interval earlier, I was specifically referring to the Q4W dosing, which is a unique interval for patients with atopic dermatitis. As an ongoing theme in our AD trials, starting with STREAM-AD, which utilized Q4W dosing, and continuing into COAST 1 and COAST 2, it's clear that I meant Q4W dosing when discussing expectations from KOLs. Regarding your mention of Q12W, I would point out three significant data points. First, there's the cessation study from STREAM-AD, which included an off-drug study component. Notably, over 60% of patients maintained their response at 24 weeks, indicating the rationale behind the proposed Q12W dosing for both induction and maintenance purposes. Additionally, across the nine studies in the OCEANA's program, at least four—COAST 1, COAST 2, SHORE, and AQUA—will consistently feature QW dosing. Lastly, I appreciate your observation about the asthma study, where Q12W dosing appears promising, enhancing our understanding that OX40 ligand modulation of T cells in disease has potential for longer interval applicability.
Okay. Thank you, Houman. Let's see, I think we've come to the end of our time. Is there any other last question? Thanks, everyone, for your participation in today's call, and we look forward to reporting on our results next quarter.