Sanofi (NASDAQ:SNY) reported second-quarter financial results on Thursday. The transcript from the company's second-quarter earnings call has been provided below.
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Summary
Sanofi delivered a strong Q2 2026 performance with a double-digit sales increase and double-digit EPS growth, mainly driven by new pharma launches and Dupixent's continued growth.
The company upgraded its full-year 2026 guidance, expecting around 10% sales growth at constant exchange rates with a slight increase in business EPS.
Sanofi's new CEO, Belén, emphasized a focus on mid- and long-term growth through strategic initiatives such as improving R&D productivity, enhancing partnerships like the one with Regeneron, and exploring disciplined M&A opportunities.
The pipeline review is ongoing, with some pipeline programs already discontinued to focus resources on assets with the highest potential.
Future outlook includes continued growth in Dupixent sales, a focus on expanding rare diseases, and leveraging opportunities in the Chinese market.
Management highlighted operational improvements contributing to financial performance, particularly in managing gross-to-net adjustments for Dupixent, and a commitment to financial discipline and sustainable, profitable growth.
Full Transcript
Thomas Guslasen, Investor Relations
Hello everyone. This is Thomas Guslasen from the Sanofi IR team. Welcome to the second quarter 2026 conference call for investors and analysts. Slides can be found on sanofi.com. Please turn to slide number three. Here are the 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 the presentation. We also refer you to our Form 20-F on file with the US SEC and our French Universal Registration Document. We're going to make comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are in millions of euros and for the second quarter, unless we stated otherwise. Please turn to slide number four. Here's the agenda for today. We are welcoming Belén for the first quarterly conference call since joining Sanofi.
Belén will cover our business and her first reflections as a new CEO. You'll also hear from our CFO, Francois, and our Head of Research, Mike. On the pipeline, we've expanded to 1 hour and 15 minutes to allow for the new CEO update and plenty of Q&A. For the Q&A we also have the support of Manuela, Olivier, and Thomas to cover our global business as well as Roy, our General Counsel. You can participate in two ways: either raise your hand in Zoom or submit your question using the Q&A feature.
And with this I now hand over to Belén.
Belén Garijo, Chief Executive Officer
Thank you, Thomas. Welcome everybody. Also from my side, as you can imagine, I'm excited to return to Sanofi, ready to drive the necessary improvement and lead the organization in its next phase of growth. I'm also looking forward to reconnecting with all of you on these calls and through our wider investor relations engagement, with transparency and trust. Over the past 12 weeks I have listened, I have learned and I have completed the critical phase of my diagnosis.
We have already started translating those conclusions into decisions and, importantly, on near-term priorities. Our teams continue to deliver quarter over quarter, as seen by the results. At the same time, I have to fully recognize the challenges confronting us and the need to build strategy that delivers on mid- and long-term growth. And I can assure you that this is going to be our focus and we will do it with the right sense of urgency. At the end of the presentation I will further share my reflections since rejoining Sanofi.
And now I will focus on our Q2 headlines. Number one, we delivered strong performance with a double-digit sales increase supported by disciplined cost management, leading to double-digit EPS growth. Based on our strong performance in H1, and as we plan further sales and EPS growth in H2, albeit with a lower level of growth, we are upgrading our guidance for full year 2026 and Francois will provide additional detail around this. Transitioning to slide number six to go through our quarterly results.
In Q2 we continued to deliver very strong growth with a double-digit sales increase and this is driven by both pharma launches and the continued strength of Dupixent. Sales from our pharma launches went up by nearly 50%, led by Ayvakit, Altuviiio and Sarclisa. Established medicines were stable in the quarter. Dupixent continued its very strong growth, up 37% in Q2, and that was driven largely by volume. That means more patients receiving it. Vaccines declined slightly, mainly impacted by a high comparable from last year's influenza sales, and that was offset by solid Beyfortus and HEPLISAV-B performance.
Overall, we saw good momentum across our portfolio and we are confident in our growth trajectory. Turning to recent launches on slide number seven, our launch portfolio is a key growth driver. These medicines represent already 13% of our sales and grew over 60% in Q2. Let me walk you through the key contributors. Altuviiio continued its strong momentum in hemophilia A and remains the top choice for patient switches in the US. Ayvakit continues to expand in systemic mastocytosis, driven by continued growth in the number of patients treated and duration of treatment.
Sarclisa is performing well in multiple myeloma and we are pleased with the recent subcutaneous regulatory approval that is providing greater convenience for patients. We saw a significant contribution from the HEPLISAV-B vaccine, one of our latest additions, and the recently launched rare disease medicines Weirds and Euphylia are starting to show momentum. What is particularly encouraging is the breadth of this performance coming from multiple disease areas and the continued growth of both early and new launches.
Looking ahead, we have additional launches for these medicines and vaccines in new geographies and thus we expect this portfolio to continue driving meaningful growth. Turning to immunology on slide number eight, Dupixent has more than 1.5 million patients currently under treatment globally and sales exceeded 5 billion euros in the quarter for the first time. Growth was driven by robust demand across indications and geographies. The US also benefited from a favorable adjustment of gross-to-net deductions in the quarter that Francois will also detail.
As shared previously, we anticipate the growth rate to moderate in the second half of the year as newly launched indications annualize and comparables become tougher. In the US, Dupixent remains the number one prescribed biologic across important prescriber groups. With the recent US approval in chronic spontaneous urticaria for children, we continue to expand the depth of indications. Therefore, we have upgraded our 2030 ambition for Dupixent to around 25 billion euro sales, a reflection of the continued strong momentum.
Turning to rare diseases on slide number nine, this is an area where I see potential for greater opportunity in the future. Rare diseases sit at the heart of Sanofi's priorities. Sales in Rare reached nearly 1.9 billion euros, up by 24%, and this is driven by Ayvakit and Altuviiio. Most medicines across the franchise grew in volume, meaning that more patients are being treated for their rare disease conditions. We recognize that some conditions are more prevalent in specific communities.
This is why we have tailored our portfolio for China and recently launched two innovative medicines there: mycorsome, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy, and Roboticityneed, the first ROC JAK dual-acting inhibitor for myelofibrosis. We will continue to partner with the rare disease communities we serve and continue to bring transformative medicines to patients worldwide. Moving to vaccines on slide number 10, vaccines sales reached 1.15 billion euros in the second quarter, 5% lower than last year, and this reflects the high 2025 comparison base in influenza.
Influenza vaccine sales declined as anticipated due to the 2025 one-offs and a lower Southern Hemisphere season, but this was offset by the solid growth of our launches. First, Beyfortus sales grew by 54% to 108 million euros, driven by a late US season and continued geographic expansion. Second, HEPLISAV-B grew by 43% on a pro forma basis to 113 million euros, offsetting the expected impact of birth cohort dynamics of the pediatric franchise. Overall, the performance of Beyfortus and HEPLISAV-B shows the resilience of our vaccines franchise.
Moving to slide number 11, let me speak a bit about our Sanofi Global Health Unit. As you know, around the world millions of people still lack access to the medicines they need the most, and Sanofi's Global Health Unit is changing that through Impact, our not-for-profit brand of WHO essential medicines. Our medicines are now available in 30 underserved countries. This is a major milestone on our journey to reach 2 million patients suffering from non-communicable diseases by 2030.
But access to medicines is only part of the story because the unit is also building stronger health care systems across 40 countries with the highest unmet medical needs. Through a strategic partnership, we have reached 6.6 million beneficiaries: 6.5 million people have been screened, 1.1 million diagnosed and nearly half a million linked to care, and we have trained over 40,000 healthcare professionals and supported more than 1,000 pharmacies and clinics.
Stronger systems, sustained care. This is our commitment. I will now hand over to Francois, our CFO, for more details on our financials.
François-Xavier Roger, Chief Financial Officer
Thank you, Belén, and hello everyone. Starting with slide 13, which is illustrating our strong growth, Q2 net sales grew 17.8% to 11.6 billion euros. This growth was primarily volume-driven and included as well a couple of hundred millions of positive adjustments in gross-to-net. Dupixent saw strong and continued patient adoptions and our launches continue to experience solid momentum. Restating for Dynavax and Blueprint sales last year, sales growth would have been around 15%.
Our gross margin increased by 3.7 percentage points. This improvement benefited from the reversal of inventory provisions following Sarclisa subcutaneous regulatory approval. Excluding this item, the increase of our underlying gross margin was around 1.7 percentage points, driven by favorable product mix and efficiencies. Operating expenses increased by 13.1%, primarily driven by the Blueprint and Dynavax acquisitions. Excluding the impact of this acquisition and one-off costs, OPEX grew at a moderate single-digit rate.
As a percentage of sales, OPEX declined by 1.5 percentage points, demonstrating the strength of our cost discipline. BOI increased by 35.8%, with BOI margin expanding by 3.8 percentage points, driven by gross leverage, cost discipline and some favorable phasing of capital gains, which were roughly 80 million euros higher this quarter compared to last year. Underlying BOI growth was around 20%. Finally, business EPS grew strongly at 33.3%. Excluding share buyback and one-off items, the underlying business EPS growth reached 21%, supported by solid operational leverage.
Now turning to H1, sales growth was 15.7% and business EPS was 22.7%, partly driven by the impact of acquisitions as far as sales growth is concerned and by positive one-offs for EPS. Underlying sales growth was around 13%. We will face tougher comps in H2 and we anticipate some deceleration of our sales growth. Indeed, we will lap in H2 against a strong sell momentum last year from Dupixent's new indication as well as a consolidation of Ayvakit, which began in July 2025.
Looking further down the P&L in H2, we expect fewer one-off benefits to gross margin. We don't expect any further Regeneron development balance reimbursement and we will have reduced benefits from share buyback. Turning to our 2026 business dynamics on slide 15, we expect vaccine sales growth to be slightly negative in 2026, mainly crystallizing in H2 due to the usual seasonality of this business. For Q3 specifically, we expect a low- to mid-teens sales decrease, reflecting a different distribution between Q3 and Q4 of our respiratory vaccine sales compared to last year.
We now anticipate for the full year 2026 a tax rate of around 21%, reflecting the non-deductibility of certain impairment losses on intangible assets linked to recent pipeline decisions. Q2 marks the end of the Regeneron development balance reimbursement. For the full year 2026, the increase in royalties will fully offset this negative BOI impact next year. In 2027 we will see a negative 200 million euro BOI gap between these two items. Indeed, we expect a final negative BOI impact from the Regeneron reimbursement of about 600 million euros year on year from 2026 to 2027, while Amvuttra royalties income is expected to increase at the same time by about 400 million euros year on year as well.
We are also introducing on the right side of the slide the projections until 2030 based on VARA consensus. Take note of recent competitor data which supports our confidence in the long-term potential of this medicine. Slide 17, we are upgrading our 2026 guidance to reflect strong business momentum to date. We now expect sales growth of around 10% at constant exchange rates, with business EPS growing slightly. Before concluding, I also want to update our 2030 ambition originally provided in 2023.
Before reviewing the details, a quick word on foreign exchange: when we set this ambition three years ago, we used the euro-dollar rate at that time as our constant-currency baseline. Today we are presenting these updated ambitions still at constant exchange rate but with today's rate, which is less favorable than it was in 2023. With that context in mind, I'm pleased to confirm that we are upgrading our sales ambition for the three items combined by almost 10% on a like-for-like basis.
At constant exchange rates, we raised our Dupixent sales ambition for 2030, which is now expected to reach about 25 billion euros. Driven by growth across all indications, our ambitions for pharmaceutical launches remains unchanged and should generate about 10 billion euros in sales, reflecting the strength and diversity of our launch portfolio. And finally, our vaccine business is expected to reach about 9 billion euros in sales thanks to our differentiated portfolio and innovation.
The 1 billion euro reduction is split equally between a currency impact and market dynamics. These ambitions reflect our strong commercial capabilities. Let me now hand over to Mike to cover the pipeline section.
Michael Quigley, Chief Scientific Officer and Global Head of Research
Thank you, François, and hello everyone. I'm Mike Quigley, Head of Research, and I'm here today representing the R&D organization. We're thankful for the work Houman has done in the past three years and wish him all the best. We're looking forward to welcoming Paulo in September. On slide 19 is a status of recent pipeline news. Beginning with regulatory approvals, we received a US label expansion for Dupixent in chronic spontaneous urticaria in children, a US label expansion for Tzield in stage 3 type 1 diabetes, and Wheyrels in Japan for immune thrombocytopenia.
Sarclisa also became the first anticancer medicine approved in the US, EU, and Japan to be given either subcutaneously or via an on-body injector. In addition, Senrifke received EU approval for the treatment of secondary progressive multiple sclerosis in patients without relapses, representing an important advancement by addressing disability progression. Turning to our pipeline, several Phase 3 studies did not achieve the outcomes we had expected, including two studies of Dupixent in lichen simplex chronicus, a second Venglustat study in Fabry disease, and riliprubart was stopped early in refractory CIDP based on an IDMC recommendation, while the Phase 3 in IVIG-treated patients remains on track. Amlitelimab showed sustained response in the ESTUARY long-term study, although we subsequently decided not to progress to regulatory submission as part of an ongoing strategic assessment of the pipeline. Finally, Nexviazyme met all study endpoints in infantile-onset Pompe disease. In addition, we received four regulatory designations, further reflecting the breadth of our commitment to providing more treatment benefits to patients.
With that overview, let's take a closer look at some of those developments over the next few slides. Now turning to slide 20, I'll highlight the latest updates from our immunology pipeline aligned with Belen's strategic review, which he will discuss in more detail later. In Dermatology, the ESTUARY Phase 3 study of Amlitelimab in atopic dermatitis showed sustained maintenance of clinical response without relapse for up to 72 weeks, with no new cases of Kaposi sarcoma.
However, we've decided not to progress to global regulatory submission as part of an ongoing strategic assessment of the pipeline. Turning now to Devakatub, we plan to initiate two Phase 2 studies in hidradenitis suppurativa and in fibrostenotic Crohn's disease, complementing our focus in inflammatory bowel disease. We have discontinued itepekimab programs across COPD and chronic rhinosinusitis, and while in tumfib programs after Phase 2 studies in Crohn's disease and ulcerative colitis did not meet our internal efficacy expectations.
Now with rare diseases on slide 21, at ATS, we presented new Phase 2 data for F Doroplin alpha in AATD emphysema, demonstrating superiority over standard of care in achieving and maintaining normalized functional AAT levels dosed every three weeks. F Doroplin alpha achieved mean functional AAT trough levels more than three times higher than those observed with weekly plasma-derived AAT at week 32 and was detected in every lung lobe of each participant at week 24.
The safety profile was comparable to the current standard of care. These data will support our discussions with the FDA on a potential regulatory submission. Already in the second half, we also presented highly encouraging Phase 3 results for Nexviazyme in infantile-onset Pompe disease, with 94% of infants alive and free from invasive ventilation at week 52. Additionally, improvements were observed across all key secondary endpoints, with safety consistent with the established profile.
These data will support our discussions with the FDA on a potential label expansion specifically in the US, as approvals were already secured elsewhere. And finally, as mentioned earlier, we are pleased that Venglustat received US priority review for type 3 Gaucher disease with a target action date of November 25th. Moving to oncology on slide 22, Sarclisa's subcutaneous formulation, including an on-body injector, is now approved in major markets across different lines of treatment in multiple myeloma.
The Sarclisa on-body injector is a compact battery-free device with a hidden needle that automatically delivers the medicine with no manual push and no bioactive excipients. It was designed to enable potential at-home administration either by a healthcare professional or by the patients themselves where approved and potentially supported by telemedicine. We are pleased with the regulatory approvals in major markets and expect a regulatory decision in China next year.
On slide 23, let me share the status of our key mid- and late-stage development portfolio. Despite deprioritizations announced earlier, there is a pipeline of important medicines and vaccines for patients, where we continue to advance our portfolio with several upcoming important data readouts. Let me now turn to slide 24 and review our expected news flow through the remainder of 2026 and into 2027 and 2028. For the remainder of this year, we expect the final Phase 3 readout for Sarclisa in transplant-eligible multiple myeloma that will result in another US label expansion.
Next year, we expect Phase 2b results for PREDECAMAG in hidradenitis suppurativa, followed by several Phase 3 readouts including frexalimab in relapsing multiple sclerosis, riliprubart in CIDP compared to IVIG, and our pneumococcal and yellow fever vaccines. In 2028, we expect multiple Phase 3 readouts for WELS and IgG4-related disease and warm autoimmune hemolytic anemia, as well as frexalimab in secondary progressive multiple sclerosis and Sarclisa in smoldering multiple myeloma.
Beyond these clinical milestones, we also anticipate multiple regulatory submissions based on data generated over the coming years, together with regulatory decisions for medicines and vaccines already under review. In representing the research team at Sanofi, we are more focused than ever on starting to deliver meaningful science and patient benefits into the pipeline from our research portfolio. Two external opportunities entered Phase 1 in the second quarter, with internal projects to follow in due course.
This year alone, we plan approximately one new Phase 1 start every two months, a meaningful step up as the changes in research take flight. Finally, on slide 25, I'd like to highlight our updated Epidemiology Data Book, which provides the latest estimates across many indications represented in Sanofi's portfolio and pipeline. It is now available on our website. Before I conclude, I'd like to thank all our colleagues in Sanofi R&D for their ongoing commitment in this time of change and for their unwavering focus on creating new medicines and vaccines for patients.
With that, I'll hand the call back to Belén.
Belén Garijo, Chief Executive Officer
Thank you so much, Mike. So let me briefly share now my first reflections since I joined Sanofi. To start with, let me reiterate my overarching comment that I mentioned at the beginning of the call. I have to fully acknowledge the challenges confronting us and the need to act with a sense of urgency in order to deliver strategy that improves the perspective of the mid- and long-term growth. So I have spent my first 12 weeks on the ground close to our people, our science, and our stakeholders — the stakeholders who will shape Sanofi's future.
I am on slide 27. On people, through either town halls or country visits, I engaged with company leaders and I took these opportunities to take the temperature of the organization as well as to share my own expectations. In this chapter I have seen firsthand the strong commitment of our employees to Sanofi as well as the deep expertise that we have in the company. Going forward, I plan to build on this commitment to foster a performance-driven culture, greater accountability, an ecosystem where people are empowered to make more agile decisions.
On science, I also visited R&D sites in France and in the US, interacting with our scientists and, importantly, I also spent time in China, a market that is evolving rapidly into an impressive ecosystem that we must further leverage. When it comes to R&D and the pipeline, it is very clear to me that we need greater scientific rigor, fact-based decision making, stronger even if leaner governance, and more effective operations. We also need to strike the right balance between internal and external innovation in order to improve our productivity.
That is why I launched very early a comprehensive outside-in portfolio review which will inform decisions on our pipeline. Now, focused on the late-stage pipeline, some of which we shared last week and earlier today. And when it comes to business, our ability to deliver commercial results in the US and Europe, as demonstrated by this strong Q2 performance, is a key strength. We can also capitalize on our local footprint in a deglobalizing market, one with greater accountability and empowered country leadership, which will contribute to decomplexify the organization and eventually allow us to move with more agility.
Overall, what is clear to me is that Sanofi has core strengths, and it will now be the disciplined choices that we make that will define our next chapter. We are actively developing a comprehensive enterprise strategy versus what has been done before, focused exclusively on the business unit, to be able to identify and unlock opportunities. On slide number 28, I want to highlight some of the early decisions that we have already made as well as some of the key priorities for the months ahead, laying the foundation for our mid- and long-term roadmap.
First of all, on people, we have appointed Paolo Futura, an accomplished physician, scientist, and highly respected leader to head up R&D. Paolo is scientifically rigorous and has a proven track record of leading large global organizations and advancing innovative pipeline. Paolo joins a more focused executive committee that was announced last week. Going forward we will build on Sanofi's employees' commitment to drive a culture of greater accountability, high performance and, once again, faster, more agile, fact-based decision making.
On science, we have moved fast, making decisions on ALI Telemap, as we communicated a few days ago, Itepekimab and Balina Tung Fib, as Mike mentioned, as well as Duba Kituk, where together with our partners we have already defined the next two indications. The priority now is to fast-track our wider R&D transformation under Paolo's leadership. We are not going to wait for a minute, and we are already engaging into the early phases of the R&D transformation, starting, as I mentioned, with the latest-stage pipeline strategic review: more rigor, more diligence, better returns, and always greater patient-centricity.
Our portfolio review is ongoing and we will share our progress in the quarters to come. It is also absolutely imperative that we intensify our business development and M&A activity in a disciplined way to enhance our mid- and long-term growth prospects. As I already mentioned before, on the business, we remain committed to immunology, rare diseases and vaccines, and we are evaluating, as part of the strategic exercise, additional growth opportunities.
On rare diseases, I am convinced there is a greater opportunity for us ahead, given our strong capabilities and our market leadership position in this attractive market segment. In terms of priorities, we will further build on our strong capabilities in the US and Europe, we will continue to develop in Japan, and we intend to expand our presence in China. And you may have seen we have nominated Thomas Trion, Head of Vaccines, to lead China and our expansion there, given the vibrant ecosystem and rapidly advancing science, combining decision-making with speed and agility, pro-innovation policies, and exceptional talents.
Let me talk about something which is very close to my heart. The alliance with Regeneron is of strategic importance for Sanofi. Our discussions to identify opportunities for further collaboration have been productive. These conversations are ongoing and will continue in order to determine the best path forward for both Sanofi and Regeneron. And finally, on financials, François has presented the upgraded 2026 guidance as well as the 2030 ambition.
Reflecting our strong business momentum, we will continue to focus on sustainable, profitable growth with a strong focus on cash generation. I see also an opportunity to operate with greater financial discipline and to focus our resources on the top growth drivers. Yet we are confirming our capital allocation principles, and that includes our commitment to the dividend and our dividend policy. Moving to slide number 29, last but not least, from September 1st, to deliver on the priorities I outlined, we will have a more focused executive team.
The members of the COMEX are experienced professionals who will work together, who will stand behind the strategic decisions of the company. In order to shape our future direction, we will have to make disciplined choices and execute those choices with focus in order to create value for our shareholders. Together, we will continue to deliver for our patients, our people, and all our stakeholders. Let me close with this. I'm leading Sanofi by delivering concrete actions today already after 11 weeks since rejoining, while actively working on an enterprise-level strategy to strengthen our growth trajectory in the mid and the long term.
We aim to engage with you on our strategic direction over the coming months — over the coming months and latest by the end of this year. In the meantime, you can continue to expect that we will operate in a disciplined, agile manner while being decisive and transparent. Sanofi has strengths, opportunities and also challenges. What we need is focused decision-making, discipline and executing with a sense of urgency. And this is exactly what we aim to deliver.
I want to take this opportunity to thank all the Sanofi colleagues I have met today and those who I will meet, because their openness, genuine feedback, passion and commitment are absolutely invaluable. At closing, I want to thank you for your time. Before we come to the Q&A, and now over to Thomas.
Thomas Guslasen, Investor Relations
Thank you, Belen. And we'll now open the call to all of your questions. As a reminder, we would like to ask that you limit your questions to one or perhaps two each. There's also an opportunity tomorrow for many of you with the sell-side meeting and also investor meetings over the coming days. You'll be notified when your line is open to ask a question. At that time, please make sure you unmute your microphone. There is also an option to submit your question by clicking the Q&A icon at the bottom of the screen, and then we'll read out your question.
And then with that, I'll hand over to Marie who will take the first question.
Marie, Operator
Yes, the first question is from James Quigley from Goldman Sachs.
Thomas Guslasen, Investor Relations
James, great, thank you.
James Quigley, Analyst at Goldman Sachs
To my question. I've got two, please. So firstly, Belen, on the Regeneron alliance, you've got the benefit of being external to the history of the alliance and a fresh perspective. So can you give us an idea of, from your point of view, what are the key factors that may be blocking faster progress here in terms of adding assets into the collaboration? And you say you're in early stages of the discussions, but what should we think in terms of timelines?
Could we see an update here in 2026 or is that too early? And secondly, on R&D strategy, you highlighted accelerating the R&D transformation is key. What are the key priorities that you have for Paolo as he comes into the seat? Similarly, will he have additional resources here? Sanofi's R&D-to-sales ratio is still at the bottom end of the sector. So is it a case of how much you spend versus where you spend it? Any thoughts there would be great. Thank you.
Belén Garijo, Chief Executive Officer
Hi James, thank you very much for your question. So look, my impression on the alliance is that first of all, we have been extremely successful in driving Dupixent. And as I mentioned, it is of strategic importance to Sanofi and to Regeneron that we identify the path forward for future collaboration. To be honest, my fresh impression is that as for any partnership, trust is absolutely essential and, for different reasons that I'm not going to judge, I didn't have the feeling that that was at this time one of the environments in which we have been operating.
So my main objective, together with Manuela, who is the head of Specialty Care here with me, has been to rebuild trust. To rebuild trust. To be able to be transparent to one another, to be able to create a path forward for this conversation. I mean, we speak quite often and, while I will refrain myself from making any commitment on timing, as I mentioned, the conversations I feel are productive and we will further disclose to you whenever an agreement is reached in the future.
Manuela, do you want to add anything? Perfect. No, please. So on the R&D spend and where to spend, as you see, as we have mentioned several times, we are right now in the process of reprioritizing our pipeline in order to focus on the strongest science, the highest unmet medical need, and where we can create long-term sustainable value for patients and shareholders. And in that context, we are going to, in coming months and in the short term, let's put it that way, we are expecting to have moderate increases on our R&D spend and obviously, as we move forward, our R&D spend will move in parallel to any potential BD or M&A that we may add in the future. So I don't know. François, you want to add anything?
François-Xavier Roger, Chief Financial Officer
No, I think our investments are driven by contribution to growth and returns over time. So this is what will drive our choices, be it in R&D or in the commercial side and industrial side as well.
Marie, Operator
Next question is from Sashid Jain from BofA.
Sachin Jain, Analyst at Bank of America
Hi there. Sachin Jain, Bank of America, and Belén, good to connect again. So just a couple of questions. So first on M&A, you referenced disciplined licensing and BD. So one of you could talk about size of deals you're thinking about within your diagnosis. Is the conclusion that a larger single deal is required or multiple smaller? Just trying to get a sense of in your early days, how much has changed from Sanofi's recent BD strategy? And then areas of initial focus.
You called out both rare and China. Is that fair for us to think about as the initial focus, or could it be broader? And then I just had clarifications to the prior answers. So Regeneron, you call out trust, which is interesting given this litigation ongoing between the two companies, on the Dupixent litigation on the rebates, which is in the early stages. Does resolution of that influence the timing of any progress? And then on R&D, when you say moderate, could I just clarify, is that in line, or could R&D grow faster than sales?
Belén Garijo, Chief Executive Officer
Thank you. So let me start by your first question, which is size of the deals. So traditionally Sanofi has been on smaller deals, bolt‑ons to eventually increase innovation or fill gaps. I think our appetite for bigger deals is an option, but obviously this is something that will be subject to opportunity, feasibility, and really ticking the boxes of three pillars: our strategic fit, the science and the potential to deliver innovation, and of course our financial guardrails.
I guess today we are open to eventually consider bigger deals. Rare and China, not exclusively. We are looking at our disease area strategy. So forget about looking at this as immunology and inflammation. We are looking at the disease area level. So where are we strong? We are strong in dermatology and respiratory. So anything that is going to help us, and in rare, of course, anything that is going to be helping us move faster and accelerate our mid and long term growth, will be an option that we can consider.
China is a priority for us. I mentioned that already. My own impression is that we have lost a bit of momentum in China. Now we have to catch up and benefit from the wave of innovation that is emerging in China. But we will do that in parallel. We will do that in parallel because our strategy in China may not be completely mirroring the strategy that we are going to have globally because the Chinese market can be served in many different ways. On the Regeneron litigation, let me make only an initial comment.
Our current focus is Dupixent one, two, Dupixent, three, Dupixent. And of course identifying opportunities to work better together. This is something that requires—it's a dynamic conversation and, of course, as them being the commercial lead and them being the development lead may, after many years, require some small refinements. And this is the focus that we have today. But you know, if you specifically want anything on the litigation, Manuela, please.
Manuela
Yeah, so just briefly, first of all, the litigation focuses on a narrow issue concerning information sharing. And as Belén said, the most important thing and the focus of the alliance is maximizing the opportunity with Dupixent, which we're already doing, as you can see in our Q2 results, continuing to do that. And in the meantime, we're having really productive discussions, frequent discussions, as Belén has shared, and we will continue those discussions.
And that's what we are really focusing on—delivering on the business collectively as an alliance. I believe it's one of the most successful alliances in the industry. And then really continuing our productive conversations. This is what we're focusing on and this is where we put our energy.
François-Xavier Roger, Chief Financial Officer
Sachin, just to complement what Belén said earlier on BD and M&A, we need to address obviously the lessons and the learnings from our pipeline lately and the weaknesses that we have. So we need to make our M&A and BD strategy evolve a little bit. So we talked, as Belén said a few minutes ago, in the past of essentially focusing on early-stage assets. We will continue working on that because we need them as well. But we will probably make it evolve a little bit with more interest for late-stage assets and potentially commercial assets.
Not one single deal you talked about. It could be a different structure anyway. We need to adapt as well to whatever is available. But we are certainly—BD will be a way to address the challenges that we are facing with our pipeline. Given that the pipeline will not be able to address it with an immediate impact on our financials in the short term, it's less a matter of amount; it's more a matter of relevance, as Belén said earlier, in terms of fit with our strategy, in terms of scientific relevance and financial return.
So we are not focusing on a given amount, for example, but more on the strategic, scientific and financial relevance of what we do. You asked a question about the R&D as well. Is it going to grow faster or in line with our sales? In the short term anyway, given the challenges that we have and the decisions that we have made lately, it will grow to a moderate level in R&D, which means at a lower level than sales. But as we grow over time and as we gain confidence in our capabilities as well, it will certainly increase.
Marie, Operator
Next question is from Pete Verdult from BNP Paribas. Pete, hello. Okay, Peter, we don't hear you. Yeah, okay, maybe we try the next one for now. We are from Beren—
Pete Verdult, Analyst at BNP Paribas
Oh, yes, hello. Hello. Sorry, sorry guys, a user error. Sorry. Pete Verdult here, BNP Paribas. Belén, welcome back. Just two questions. Firstly for you, Belén, could you remind us how much of the 10 billion R&D budget is discovery versus development, and would there be any appetite, perhaps from a strategic point of view, to become more search-and-development going forward than research-development at Sanofi? And also interested in how you're thinking about immunology in light of the numerous pipeline failures and your ability to transact outside of the collaboration.
And then secondly, and more quickly, just for François or Manuela, you know, it's very rare that on Dupixent there's a 10% miss from consensus between consensus and reported numbers. You've talked about the true-up. We can see volume growth is robust, but it does seem that there's a sort of 10 to 15% positive impact from either price or channel mix. So maybe once—well, I mean, could you just give us a bit more detail about what's going on there to sort of give us the bridge from volumes to the reported growth?
Belén Garijo, Chief Executive Officer
Thank you, Peter. I give you the high-level answer to the R&D budget. So the majority of the R&D budget is clinical development. Mike, correct.
Michael Quigley, Chief Scientific Officer and Global Head of Research
Thanks, Pete, for the question. Belén, you're absolutely correct. That being said, I think there's an absolute commitment to research as a long-term pipeline sustainability and cornerstone of that effort that we have that's been relevant to Belén's statement and strategic review. Another thing I'd add for the benefit is there's not a linear relationship between spend and outcome. And so as we think about making the most use of the budget we have to deploy within R&D, it's critical to make the right decisions—both strategically and rigorous, as Belén mentioned earlier—around what we continue to progress versus what we make sure we dynamically allocate away from those medicines that aren't promising. So the key for that is really how we use the capital allocation within the R&D organization.
Belén Garijo, Chief Executive Officer
On your second question, my immunology thoughts related to the pipeline failures. You know, I don't think it has to do with immunology, right? I mean, we have significant capabilities in that area, contacts, advisors. I think this goes back to what I said before. We need to be rigorous, right? When you make a decision to go from phase two to phase three and get ready to engage a significant amount of capital, you really need to challenge whether or not your data in phase two are justifying the move to phase three.
And you don't start by dreaming on a target product profile that is not based on rigorous assumptions. So that's basically what we are going to change. And you know, this is nobody's fault. From time to time my feeling is that there has been a period in which making decisions on these topics, on these critical topics for the company, were not very clearly placed where those belong. Right. So I am expecting the scientists to make scientific decisions, and I am expecting the scientists to make a judgment call whether the data that we have in phase two—and I am using this as an example—qualify the asset to go to phase three.
So scientific rigor, diligence, focus on fact-based decision making. I repeat, this is what I believe may have contributed, or contributed, to some of the study setbacks that we have seen lately. And we are going to pay a very significant attention to the way we make these decisions and where we make these decisions.
François-Xavier Roger, Chief Financial Officer
And Peter, the question on Dupixent. First of all, we don't disclose the breakdown between volume and price, but the growth of Dupixent, which is really, really strong in Q2—as it has been the case since the beginning of the year, by the way, which is remarkable because we are nine years after the launch—is essentially volume-led. So this is a very vast majority of the growth. As we said, there was a little bit of tailwind in the quarter due to some pricing adjustment, the traditional gross-to-net, which did help a bit in the quarter, which is not something that we will see later in the year.
But once again, I mean the growth was largely volume-led, which is reflecting what has been said earlier as well, which is a penetration of biologics across indication is really—maybe, Manuela, you want to give some additional color on that?
Manuela
And just a little bit of a brief add to what François has already said, really driven by underlying demand. And remember, Pete, that when you look at TRx figures from IQVIA, for example, that's script data that doesn't fully reflect total demand. The total demand is higher than the script data. And yes, there's fluctuation in the GTN we have seen. We have actually focused also on operational effectiveness in the area of GTN to really make sure that all of our actions have the right intention get to patients in the right way.
That has also contributed. And then the one-off GTN topic that François mentioned, but it was really—the vast majority was demand driven, and we expect that demand-driven growth to continue at a more moderate growth rate for the second half of the year.
Marie, Operator
The next question is for Luisa Hector from Berenberg. Luisa,
Luisa Hector, Analyst at Berenberg
Thank you. Hi and welcome, Belén. I have a couple of questions, another one on capital allocation. Could you confirm whether the lack of sort of conclusion on the Regeneron collaboration is a barrier to moving forward on any business development and M&A? And then on the 2030—the various components of guidance there, just your levels of confidence. In particular the pharma launches now at 10 billion euro. Could you tell us anything more on the split there?
It sounds like that is majority in-market products, but for any pipeline contribution, what is the average risk adjustment applied, and any colour on the profitability of that 10 billion versus the prior guidance?
Belén Garijo, Chief Executive Officer
Thank you, Luisa. I'm going to take the first question, which is very straightforward to answer. So we have at this time no barriers related to Regeneron to moving forward on M&A. Francois, on the pharma launches. Luisa.
François-Xavier Roger, Chief Financial Officer
The scope that we disclosed does not include vaccines, by the way. But you know, if we look at it, because we don't duplicate, we have it separate as a separate guidance. If we look at it on this Scope of the new launches, we will probably reach 5.2–5.3 billion already in the full year 2026. You can see it with what we have achieved already in H1. If you look at the like-for-like growth, which means restating for some products like Evakit, last year we were growing in H1 at about 27%. To get to the 10 billion by 2030 we need to grow on average CAGR by 15%. Given that we are on a trend of 27% today, I'm not worried at all about our capacity to reach the 10 billion.
And we are just talking of, by the way, the market. Most all of these products are already in the market, so it's essentially a commercial risk. So I'm not worried about it. You ask a question on the profitability of this business. It is already positive in terms of by, which is quite remarkable due to the fact that we are really in an investment position behind these products to support the growth of. But they're already profitable and attractive from a profitability point of view as well.
Marie, Operator
The next question will be from Graham Parry from Citi.
Graham Parry, Analyst at Citi
Great, thanks for taking your questions. So just to go back to the Regeneron alliance and BD, when you're looking to acquire immunology assets, can you just talk us through the decision-making process between putting an asset into the alliance versus going it alone? And in particular, if you were to go it alone, can you talk about the dynamics of salesforce allocation between the alliance and Sanofi standalone, and would that be a barrier to being able to do immunology assets alone?
And then secondly on R&D, Sanofi has been through many iterations of attempting to improve the pipeline. This is, I think, the third CEO I've, in my coverage, seen come in with a new plan that sounds suspiciously like the old plan. So perhaps could you just talk us through what you think is systemically wrong in the organization and if and how and how quickly that can change. Thank you.
Belén Garijo, Chief Executive Officer
So let me reply very briefly to question number one. So yes, when we go for BD, eventually M&A, and of course our respective internal pipelines, we consider whether the asset can be better performing within the alliance. Manuela, you want to add.
Manuela
No, I would just add, Graeme, that as Belén said earlier, immunology is a large space, and even dermatology and respiratory. We are looking at opportunities within the alliance. We are looking at opportunities outside of the alliance. And if we identify an opportunity outside of the alliance, given the commercial capabilities we have, we are confident that we can build the right structure and then launch these products, as we are already doing successfully in that context.
So both are options that we are currently actively reviewing as part of the strategic review that's ongoing.
Belén Garijo, Chief Executive Officer
So, Graham, I am not exactly sure what you mean that the pipeline plan sounds old. I mean, I assume that you mean that the R&D productivity issues of Sanofi have gone on for quite a while. Right. And, you know, to be totally frank, we are looking at this to take potential learnings from the past. But what is driving us is actually to improve our R&D productivity. And I have repeatedly mentioned what are the focus areas in which we are going to emphasize.
Frequently, as you know, turning around R&D productivity takes a bit of time. So we are absolutely convinced that while we reignite our R&D engine, we will have to also accelerate our BD plans and M&A, as I mentioned before. I don't think there is a systemically wrong issue in the organization. I think you have to pull the levers right, be consistent and never complacent. And, you know, managing the risk and the risk profile of the pipeline is going to be something that will be very much at the top of our priorities.
Not always aiming for first-in-class and best-in-class, but rather differentiated innovation that can help us move forward.
Marie, Operator
The next question is from Simon Baker from Redburn.
Simon Baker, Analyst at Redburn
Thank you for taking my question and welcome back, Belén. It really follows on from Graham's question, and you alluded to it in your response that you're targeting a fast-track R&D transformation. And as you said, transforming R&D is not particularly quick. The fastest I can think of in my time is probably AstraZeneca, which was four to five years. So what sort of timeframe would you put on this? I'm assuming that Paolo's arrival is not a year-zero event.
There was a lot of restructuring under Houman. So where are we in that transformation journey? And then a second quick question. All of this, of course, is focused around the loss of exclusivity of Dupixent. One of the simplest ways of dealing with that is to move the LOE out. Now, we know you have a lot of IP beyond March '31 out to 2045. I think it'd be interesting to get your early perspectives on what you think, as a fresh pair of eyes on this, what you think the strength of the IP beyond '31 is for Dupixent and therefore the more realistic possibilities on when we will face biosimilar competition for that asset.
Thanks so much.
Belén Garijo, Chief Executive Officer
Thank you, Simon. Look, I can only repeat what I have said before. My feeling is that we have a good understanding of the science and that some of the setbacks, if not a significant number of setbacks, are operational risk. Fixing operation is a bit faster than recruiting expert capabilities to the organization. So as Mike mentioned, our research efforts are already paying back. So I am not saying that this is going to be fast, but starting by managing the operational risk actually would be a very good start.
And this is what we are going to do by prioritizing, acting and deciding on scientific rigor, having the right decisions at the right level, and managing our clinical operations entirely from an end-to-end perspective from a study design to conclusion of the trial. And, you know, once again we are not counting that this is going to be fast. So BD and M&A together and in parallel to the R&D transformation. On the LOE of Dupixent, I want to hand it over to Roy.
Roy (General Counsel)
Thanks, Simon. First of all, you mentioned patents going to '45; actually this quarter we can say it's patent expiration dates going up to 2046. We have a very strong patent portfolio around Dupixent, many years of R&D, multiple innovations, nine indications to date, and of course we intend to vigorously defend it. You will appreciate it's too early to speculate on specific dates for biosimilar entry. I think what I can say based on our experience is that we do expect Dupixent to be protected beyond March 2031.
How long, when, which patents will hold—very early days to be able to speculate. If and when the typical patent fights commence, we'll be able to give you more details of what is being challenged and keep you up to speed, of course. But rest assured that we have done our best to make sure that the years of innovation are being protected and we intend to really fight it out.
Belén Garijo, Chief Executive Officer
What I can tell you, Simon, is that we are taking a base case that is associated to the patent, to the loss of the product patent.
Marie, Operator
The next question is from David Risinger from Leerink.
David Risinger, Analyst at Leerink
Yes, thanks very much, and congratulations, Belén, on your new role and thank you for your comments today. So beyond Dupixent target increases longer term, could you please discuss what investors may be underappreciating about Sanofi's future prospects? And then just turning to R&D, there have been a lot of questions. It seems to me that you're simply focused on improving judgment and empowering better decision-making from the ground up. Is that the right way to interpret your comments today?
Belén Garijo, Chief Executive Officer
Thank you, David. So first of all, I believe during my conversation with investors what I learned is that perhaps we have for a period of time overpromise and underdeliver. That's the bottom line, and this basically hit our credibility tremendously. And despite the results of today, for me as a newcomer, it's really shocking that the strong performance of this company is really not recognized by investors. And that is the only reason that I can find and that I have been able to elucidate during my conversations with investors.
Any other comments in this respect?
François-Xavier Roger, Chief Financial Officer
Maybe let me add something that if you look at valuation in our industry, it's essentially driven by two drivers. One of them is growth. Belén just said it. I mean we tick the box fully on that because we have one of the highest levels of growth in our industry. The other one is pipeline, on which we know and we made some disclosure lately on our pipeline. So we are aware of the challenges there as well. I think that there is an understanding as well that the market is waiting for not only talks but actions, and this is what we are working upon.
And I think that we are all working here in this organization in order to not only talk but execute and act, which we will see certainly in the coming months.
Michael Quigley, Chief Scientific Officer and Global Head of Research
Yeah. On the R&D transformation, yes, I think your interpretation is right, David. Amongst other things, improving decision-making—I gave an example to Pete Verdult on a transition between phase two and phase three, which is a very critical decision. So you are absolutely right that we want to improve decision-making based on facts, scientific rigor, and clear accountability at the science level and at the commercial level.
Marie, Operator
The next question will be from Seamus Fernandez from Guggenheim. Seamus.
Seamus Fernandez, Analyst at Guggenheim
Thanks very much for the questions, and congrats, Belén, on the coming out event here. I guess the two questions from my side: you mentioned two areas that haven't quite been a major focus of the prior management, rare disease, and then also I think your comments on China are interesting. So I just wanted to clarify two things. First, as it relates to rare disease, is this an area that you see for accelerated business development in the context of Sanofi really leveraging the Genzyme history to a greater degree?
We've seen very strong developments across the board in rare metabolic disorders across the industry, and it's not an area where Sanofi has really participated in some of those new growth opportunities. From our perspective, AAT is a very interesting incremental opportunity, but just interested to understand how you're thinking about staying concentrated in those areas or perhaps broadening. And then on China, I just wanted to clarify, are you specifically talking about accessing the innovation in China?
It is something that the industry is chasing quite aggressively and we're hearing that the bids have maybe gone beyond what would be characterized as value opportunities in the industry. Or are you talking about the market itself and the opportunity to reinvest in the market to drive growth.
Belén Garijo, Chief Executive Officer
Thank you very much. So I hear echo, do you hear me? Yes. You hear me? It's okay. So, rare. Yes. In rare, I believe we have an opportunity, first because the scope is broad. So we are not going to focus exclusively on rare genetic disorders. We are going to further expand to leverage our capabilities and our podium position because we have a top two or three position in the rare disease market. And I believe this presents an opportunity and is giving us and giving our business significant resilience.
I think on China it is both. The market is attractive simply because the population is extremely big. So even if the pricing environment is very different than in other countries, the volumes that you can draw from China for specific indications or diseases is attractive. Right. So that is one element of it. And obviously tapping into partnering with companies that are now highly innovative and intend to out-license that innovation for global commercialization is also an area in which we are going to be doubling down.
Marie, Operator
The next question is from Michael Lushton, from Jefferies. Michael.
UNKNOWN, Analyst
Oh, thank you very much. Two questions please, around the COMEX changes. Belén, one, obviously you're kind of an outsider with prior experience and you've brought in Paolo as an outsider. But the rest of the COMEX change is really internal candidates. Can you talk about sort of pluses and minuses of not having more new blood in that COMEX to really affect a change? You made a very strong point about this being a big job and requiring really drastic changes.
And then a related question to François on your role now also including BD, what changes does that make for you? Does that just increase the speed of action you can perform at? Does it increase the flexibility? Just talk about the sort of options you have now that previously were not open to you.
Belén Garijo, Chief Executive Officer
Michael, thank you for your question. So, on the COMEX changes. Look, I go externally when I believe that is necessary to search for a more transformative position, right? And this is what we have done in R&D. However, when you look at the COMEX, there are three new members, the three of them from our internal talent pipeline. Manuela, who came a bit earlier than I joined, but you know, she has been in the job for months and came from our internal talent pool.
Jamie, who was groomed by Roy and was absolutely ready to take the job, and a leader in Vaccines who is now going to take General Medicine. And that makes a lot of sense because General Medicine is a Sanofi-specific business. So over the years I have learned that you always take less risk when you source from internal talent than going outside. But having the optimal blend between external eyes and external expertise and internal talent is a very good option.
And this is what I have tried to do with the COMEX. I mean, there is a significant percentage of the COMEX. So now we are eight, three are new COMEX members — that is a significant percentage with new eyes and new blood, as you call it.
François-Xavier Roger, Chief Financial Officer
So on my role on BD, first and foremost, I'm aware of the responsibility that comes with it. I think second, we have been very successful in BD and in M&A. But just to give you some perspective, globally between BD and M&A, we invested 47 billion euros for the last eight years and we have lost 7 billion. Sorry for the 7 billion, but if we had not lost anything, we would not probably have taken the right level of risk. But we have created quite a substantial value historically with the remaining 40 billion.
And I'm sure we'll have the occasion to discuss a little bit more in details what I'm just sharing with you. So we have a good track record both in BD and in M&A. I'm honored as one to take over this responsibility because we know that, as we discussed earlier, BD and M&A is part of the challenge that we have in order to address some of the weaknesses that we have within the organization. The fact that we have it under one roof will allow certainly a better coordination, although it existed before.
But what I insist upon as well is that BD is not necessarily naturally within Finance in many organizations in pharma, but it can be successful only if there is a very close coordination and very close proximity to R&D. This will be my main priority, to make sure that even if it sits within my scope of responsibility — especially for BD, less obviously for M&A — it will work only if we are super, super close to the R&D organization.
Marie, Operator
The next question is from Richard Vosser, from J.P. Morgan.
Belén Garijo, Chief Executive Officer
Richard, hi.
Richard Vosser, Analyst at J.P. Morgan
Thanks for taking my questions. Just a couple, please. So, Belén, you've cut a few pipeline programs. Should we think that the review is now complete, or should we think about further discontinuations when Paolo joins? And on that remaining pipeline, there are a couple of Phase 3 assets that read out in the coming 12 months for Axalamel and Ripraboo part — apologies for the pronunciation, never going to get it. There's some discussion around the chances of success on both.
So on Frexalimab, there's been discussion on the primary endpoint in Phase 3 and the ability to beat placebo. So just interested in your thoughts and Michael's thoughts there. And then on Ripraboo part, the MOBILIZE trial failed, obviously. What are the learnings for that? For the VITALIZE trial, are you comfortable that the patient population enrolled will be responsive to the drug? Thanks very much.
Belén Garijo, Chief Executive Officer
Thank you, Richard. So the pipeline review is ongoing, so I'm not excluding that we discontinue some additional assets, but we don't have a target number to discontinue. Right. We are going to continue to be operating on the basis of scientific merits and risk, as I mentioned, and potential and some other elements. So at the end, after a thorough review of our pipeline, we will be once again concentrating our resources. And this is the bottom line: we will be concentrating our resources in those with highest scientific merits, highest unmet medical need and highest potential.
On Frexa. Do you want to comment?
Michael Quigley, Chief Scientific Officer and Global Head of Research
Mike — thank you, Belén, and thank you for the question, Richard. On Frexalimab, in the context of the Phase 3, we're on track to read out RMS in 2027 and SPMS in 2028 as you referenced. We've been actively working with global regulators to refine our statistical analysis plan, really with an eye to testing realistic endpoints of interest for patients given the recent performance of comparators in RMS studies, and rest assured that that will continue to be a focus.
The primary doesn't change in the context of annual relapse rates, but we're focused also on key secondary endpoints including a six-month disability progression. In the context of the Frexalimab readouts that you'll see with respect to MOBILIZE versus VITALIZE, that's a key question. What I'd say — and what we put out — was that the IDMC recommended not moving forward in the context of the MOBILIZE study because you were unlikely to meet the primary endpoint.
What I can say is that the two patient populations between the two studies are very different. So we have a refractory patient population in the MOBILIZE study — very hard to treat. These patients don't have, unfortunately, anything available to them. I contrast that to the VITALIZE study. These are patients that are on IVIG but still are progressing despite that treatment paradigm. And so that comparison versus IVIG in that patient population is where we're looking at in VITALIZE.
Importantly, what I can also add is that the IDMC looked also at VITALIZE and recommended progressing VITALIZE forward. And so we have hope and we're on track to continue to read that out in the latter half of 2027.
Marie, Operator
The next question is from Matthew Weston from UBS.
Matthew Weston, Analyst at UBS
Matt. Thank you very much. Belén, a warm welcome back. My first question's for Manuela and it comes back to Pete's question on Dupixent gross-to-net. Can I push you on your operational effectiveness comment? Has the alliance changed its policy on 340B claims for Dupixent to reduce access to heavily discounted drug? And I ask that because that's the only thing I can think of that's the really significant improvement in GTN over the first half of the year.
And then I guess, if that is the case, why won't that trend continue and why shouldn't Dupixent be able to deliver stronger than is suggested by the 10% total revenue guide that we've increased to? And then my second question is about the long-term guidance for Vaccines. You bought Dynavax, but you cut the 2030 vaccine guide by 10% to 9 billion euros. I know that some of that is FX, but is it because you're meaningfully more cautious on Beyfortus, or is it the flu franchise, or is it something else?
Manuela
Yeah, so thank you, thank you, Matt, for that question. So when we talk about operational improvements, operational effectiveness, fully agree that it is linked to 340B partially. So GTN, as I said, there's a portion that is recurring, there's a portion that is non-recurring. The non-recurring portion is a couple of hundred million. The recurring portion, exactly as you say, is linked to us really looking at how do we ensure patient benefits that reach the intended recipients. 340B — enhanced 340B control — is a part of that. It's not the only part, but it's a part of that, a large part of it. And there we've been, thanks to the team, successful. And you're right, some of that will continue to occur also in the second half. The reason why we're talking about a more moderate growth in the second half versus the first half is simply the second half last year was a higher comparison. So we now have a higher base that you're comparing us to, and we are also annualizing some of the indication launches, and those two contribute to a slight moderation of that growth versus the first half of this year.
Thomas Triomphe, Executive Vice President Vaccines
Regarding the second question, hello, Matt — Thomas speaking. So thanks for the questions. For the 2030 Vaccines ambition, you've noticed the change indeed when you look at the difference between the two numbers, and you remember first of all that this ambition was put in 2023, if I recall correctly — so way before the change of administration. When we look at the drivers of this, this 1 billion difference for 2030 is coming — one half of it — from a U.S. exchange rate, so U.S. to euro; it's pure financial exchange rate. The second half is driven mostly by U.S. VCR. So U.S. vaccination coverage rate, which has turned out to be weaker than expected following the new U.S. administration. And indeed it's mostly into the respiratory area, so classical flu and RSV. But also you've seen that CDC and other avenues have shown that there has been a decrease on the vaccination coverage rate of U.S. pediatric vaccines also.
So if you put both together, that explains the difference. It doesn't change anything on our long-term ambition for Vaccines. The fundamentals are very strong in terms of growing elderly population, our focus on the pipeline on the elderly segment. But indeed we wanted to recalibrate what has changed with the latest both exchange rate and U.S. overall, I would say, policy.
Marie, Operator
The next question is from Florence Espès from ODDO.
Florence Espès, Analyst at ODDO BHF
Good afternoon. Florence Espès from ODDO BHF. Thank you very much for taking my questions. Two quick ones, please. First, for Belén: you have announced that you have discontinued some of the projects, some products in the pipeline. I understand that the portfolio review is ongoing, but do you have some projects remaining in the pipeline where you have strong confidence? My first question. My second question for Thomas: on China, maybe could you elaborate a bit on your strategy there and how do you see the dynamic of this market going forward, which is a little bit soft these days?
Thank you.
Belén Garijo, Chief Executive Officer
Hi, Florence. So listen, of course as we prioritize our assets, confronting stage of development versus potential, understanding of the biology versus pace of development, etc., you know, you get a picture that classifies those assets into most promising, less promising and in the middle of it. Right. But I think it's too soon to tell you where are we going to land with the strategic review. I think, as I said, Mike has highlighted some of the successes on the quarter and also has spoken a bit of the outlook towards next year.
So I will remain very prudent until I see data, more data, and obviously once we have those solid data that we need to see, we will come back to you to tell you. And as I mentioned during my introductory remarks, we are aiming to give you some kind of perspective in the coming quarters and obviously before the year end. We are expecting to give you a broader perspective on where we are on the strategy and the pipeline. On China, the question goes for Thomas.
Marie, Operator
The last question will be from James Gordon from Barclays.
Belén Garijo, Chief Executive Officer
James, hello.
James Gordon, Analyst at Barclays
James Gordon from Barclays. Thanks for taking the questions. Two questions, please. One was on M&A and BD. When you're thinking about which therapy areas to focus on, do you need to have existing strength in the areas? So would you still think about doing a deal in somewhere like oncology, where you don't have a big business, or neurology, or it has to be an area where you've got significant scale? And if you're not going to acquire more in those areas, might you even say, okay, we're not going to do those areas and we'll even divest the assets?
And on M&A, how much urgency is there to complete a meaningful deal this year? Would you like to have a deal that you could talk to us about by the end of the year, or might we need to be a bit more patient? The second question was just about spend. So we've heard that I think you might need to do a bit more R&D, but is there anywhere that you might not need to spend quite so much? So are you looking to reallocate, as in you might be able to take some spend, say from SG&A, and reallocate it to R&D or not?
Is there an opportunity there? And then just squeezing in a clarification, please, on the Regeneron partnership: is it just about communication and trust, or are you actually looking at the structure of the partnership at all? Is that off the table, or is that also under consideration?
Belén Garijo, Chief Executive Officer
Let me start by the Regeneron question. So as I mentioned, it's a combination of looking at options to eventually expand the alliance with assets from both sides, right. And in parallel, looking at potential improvements to the collaboration to be more agile and to bring more transparency to the way we operate. And of course, as for any other partnership, as I mentioned before, an ongoing development of trust. So this is exactly what I have repeatedly said during the call of today: Regeneron is of strategic importance to us, and therefore we will continue the already initiated conversations to be able to land what is best for both companies.
On M&A. To be honest, it is a matter of opportunity, but you can count that it will be a combination of a strategic fit. So we will likely focus on our pillars, on our main pillars, on our core pillars. And BD is directly related to our R&D strategy and focus. So we may, after, combine M&A with BD to support platforms and research. Whenever it's more later-stage, it will be complementing what we can generate inside. With those businesses that may not become at the end a priority or a growth platform for the company, we will have to evaluate options, and this is not rocket science.
It can be partnering, it can be offering those businesses to other companies, or any potential option that will create value for our shareholders. Reallocation of spend to R&D.
François-Xavier Roger, Chief Financial Officer
Yeah, I can take that one, James. But first, I confirm there is no dramatic urgency in terms of BD/M&A. We are not driven by any timing objective. We are driven by returns and contribution to growth. And the same applies to reallocation of resources and resource allocation. Obviously, as we said earlier, there might be a little bit of resources available, for example with the programs that we have decided to terminate. There is no rule saying that we have to redistribute that or reallocate it to R&D. Our choices in terms of spend—and I would rather talk of investment rather than spend—are driven by contribution to growth and contribution to return. So if there is a better return on the commercial side of things, that's what we will do. So we don't manage fixed budgets within a certain category of investments. And let me just give you an example. A couple of years ago we were still investing a lot, for example on the commercial side, behind GenMed.
But these products are mature. We have decided to reallocate most of it behind growth assets, essentially within Specialty Care and starting with Dupixent. And you saw what it means today. You saw it with impressive, almost 18% growth in Q2. So once again, our choices on cost allocation and investment allocation are driven by contribution to growth and returns.
Belén Garijo, Chief Executive Officer
Okay, so this was our last question. I wanted to thank everybody for your interest in Sanofi, and I look forward to continuing the very interesting conversation that we have initiated today. Thank you very much.
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