Sanofi Q2 2026 Earnings Report

Sanofi EPS Results

• Actual EPS: $2.41
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: $3.24

Sanofi Revenue Results

• Actual Revenue: $13.36 billion
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: +16.00%

Sanofi Announcement Details

• Quarter: Q2 2026
• Date: 7/30/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, July 30, 2026
• Conference Call Time: 7:00AM ET

Sanofi (NASDAQ:SNY) (NASDAQ:SNY) is a multinational pharmaceutical company headquartered in France that researches, develops, manufactures and markets prescription medicines, vaccines and consumer healthcare products. The company operates across multiple therapeutic areas, including immunology, rare diseases, oncology, cardiovascular and metabolic diseases, and vaccines through its Sanofi Pasteur division. Sanofi sells products to hospitals, clinics, governments and retail pharmacies, with a broad global footprint and significant presence in Europe, North America and emerging markets.

Key commercial offerings include specialty biologics and established small-molecule medicines. Notable products developed or marketed by Sanofi include Dupixent (dupilumab), an immunology biologic for conditions such as atopic dermatitis and asthma developed in collaboration with Regeneron, and long‑acting insulin products in diabetes care. Through Sanofi Pasteur, the company produces vaccines for infectious diseases and maintains global vaccine manufacturing and distribution capabilities. Sanofi’s portfolio also encompasses over‑the‑counter and consumer healthcare items alongside its prescription medicines.

The current Sanofi group is the result of decades of industry consolidation and strategic acquisitions that brought together French and international pharmaceutical operations into a single global company. Sanofi invests heavily in research and development, focusing on biologics, vaccines, gene and cell therapies, and targeted small molecules to address unmet medical needs. Paul Hudson has served as chief executive officer since 2019, leading the company’s strategic priorities in innovation, portfolio optimization and global commercial execution.

Sanofi Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Sanofi reported strong Q2 momentum, with sales up 17.8% to €11.6 billion, underlying business EPS growth of about 21%, and operating leverage from product mix and cost discipline. The company upgraded its 2026 outlook to approximately 10% sales growth at constant exchange rates, with EPS growing slightly faster.
• Positive Sentiment: Dupixent sales exceeded €5 billion for the first time in a quarter, rising 37% on robust patient volume across indications and geographies. Sanofi raised its 2030 Dupixent sales ambition to approximately €25 billion, although it expects growth to moderate in the second half.
• Positive Sentiment: The launch portfolio grew more than 60% and represented 13% of sales, led by ALTUVIIIO, AYVAKIT, Sarclisa, HEPLISAV-B, Waylivra, and Qfitlia. Sanofi said these products are expected to remain important growth drivers as additional indications and geographic launches proceed.
• Negative Sentiment: Sanofi disclosed several pipeline setbacks, including failed or discontinued programs involving Dupixent, venglustat, riliprubart, amlitelimab, ixekizumab, and balinatunfib. Management is conducting an ongoing portfolio review and warned that further discontinuations are possible, highlighting the need to improve R&D productivity.
• Neutral Sentiment: Vaccines sales declined 5% in Q2 because of a difficult influenza comparison and weaker U.S. vaccination coverage assumptions; management expects a low- to mid-teens sales decline in Q3. The new CEO also plans a broader strategy review, disciplined BD and M&A, stronger focus on rare diseases and China, and continued discussions with Regeneron on the Dupixent alliance without committing to a timeline.

Presentation

[Thomas Kudsk Larsen, Head of Investor Relations at Sanofi]

Hello, everyone. This is Thomas Kudsk Larsen from the Sanofi IRT. 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 risk 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 U.S. 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 EUR, and for the second quarter, unless we stated otherwise. Please turn to slide number four. Here is the agenda for today.

[Thomas Kudsk Larsen, Head of Investor Relations at Sanofi]

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, François, 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. With this, I now hand over to Belén.

[Belén Garijo, CEO at Sanofi]

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 this 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 a 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.

[Belén Garijo, CEO at Sanofi]

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 François 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.

[Belén Garijo, CEO at Sanofi]

Sales from our pharma launches were 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, 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 U.S.

[Belén Garijo, CEO at Sanofi]

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, Wayrilz and Qfitlia, 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, thus, we expect this portfolio to continue driving meaningful growth. Turning to immunology on slide number eight.

[Belén Garijo, CEO at Sanofi]

Dupixent has more than 1.5 million patients currently under treatment globally, sales exceeded EUR 5 billion in the quarter for the first time. Growth was driven by robust demand across indication and geographies. The U.S. also benefited from a favorable adjustment of gross-to-net deductions in the quarter that François 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 tackled. In the U.S., Dupixent remains the number 1 prescribed biologic across important prescriber groups. With the recent U.S. 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 EUR 25 billion sales, a reflection of the continued strong momentum. Turning to rare diseases on slide number nine.

[Belén Garijo, CEO at Sanofi]

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 EUR 1.9 billion, 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, and this is why we have tailored our portfolio for China and recently launched two innovative medicines there. Myqorzo, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy, and rovadicitinib, the first ROCK/JAK dual-acting inhibitor for myelofibrosis. We will continue to partner with the rare disease communities that we serve, and continue to bring transformative medicines to patients worldwide. Moving to vaccines on slide number 10.

[Belén Garijo, CEO at Sanofi]

On vaccines, sales reached EUR 1.15 billion in the second quarter, 5% lower than last year. 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. This was offset by the solid growth of our launches. First, Beyfortus sales grew by 54% to EUR 108 million, driven by a late U.S. season and continued geographic expansion. Second, HEPLISAV-B grew by 43% on a pro forma basis to EUR 113 million, 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 11, let me speak a bit about our Sanofi Global Health Unit.

[Belén Garijo, CEO at Sanofi]

As you know, around the world, millions of people still lack access to the medicines they need the most, Sanofi's Global Health Unit is changing that. Through Impact, our non-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 two million patients suffering from non-communicable diseases by 2030. Access to medicines is only part of the story, because the unit is also building stronger healthcare 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 diagnosed, and nearly half a million linked to care. 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.

[Belén Garijo, CEO at Sanofi]

I will now hand over to François, our CFO, for more details on our financials.

[François Roger, CFO at Sanofi]

Thank you, Belén. Hello, everyone. Starting with slide 13, which is illustrating our strong growth, Q2 net sales grew 17.8% to EUR 11.6 billion. This growth was primarily volume-driven and included as well a couple of hundred millions of positive adjustments in growth to net. Dupixent saw strong and continued patient adoptions, 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 subcu regulatory approval. Excluding this item, the increase of our underlying gross margin was around 1.7 percentage points, driven by favorable product mix and efficiency. Operating expenses increased by 13.1%, primarily driven by the Blueprint and Dynavax acquisitions. Excluding the impact of this acquisition on one-off costs, OpEx grew at a moderate single-digit rate.

[François Roger, CFO at Sanofi]

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 EUR 80 million 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. Turning to H1, sales growth was 15.7% and business EPS was 22.7%, partly driven by the impact of acquisition 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.

[François Roger, CFO at Sanofi]

We will lap in H2 against a strong set of 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.

[François Roger, CFO at Sanofi]

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 of Amvuttra royalties will fully offset this negative BOI impact. Next year, in 2027, we will see a negative EUR 200 million BOI gap between these two items. We expect a final negative BOI impact from the Regeneron reimbursement of about EUR 600 million year on year from 2026 to 2027, while Amvuttra royalties income is expected to increase at the same time by about EUR 400 million year on year as well. We are also introducing on the right side of the slide, the Amvuttra royalty projections until 2030 based on VARA consensus.

[François Roger, CFO at Sanofi]

We 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 a strong business momentum to date. We now expect sales growth of around 10% at constant exchange rates, with the business EPS growing slightly faster than sales. 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 rates, but with today's rate, which is less favorable than it was in 2023.

[François Roger, CFO at Sanofi]

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 EUR 25 billion, driven by growth across our all indications. Our ambitions for pharmaceutical launches remains unchanged and should generate about EUR 10 billion in sales, reflecting the strength and diversity of our launch portfolio. Finally, our vaccine business is expected to reach about EUR 9 billion in sales, thanks to our differentiated portfolio and innovation. The EUR 1 billion 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.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

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 U.S. label expansion for Dupixent in chronic spontaneous urticaria in children, a U.S. label expansion for TZIELD in Stage 3 Type 1 diabetes, and Wayrilz in Japan for immune thrombocytopenia. Sarclisa also became the first anticancer medicine approved in the U.S., EU, and Japan to be given either subcutaneously or via an on-body injector. In addition, Cenrifki received EU approval for the treatment of secondary progressive multiple sclerosis in patients without relapses, representing an important advancement by addressing disability progression.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

Turning to our pipeline, several phase III studies did not achieve the outcomes we had expected, including two studies of Dupixent in lichen simplex chronicus, the second venglustat study in Fabry disease, and riliprubart was stopped early in refractory CIDP based on an IDMC recommendation, while the phase III in IVIG-treated patients remains on track. amlitelimab showed sustained response in the ESTUARY long-term study. 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.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

I'll highlight the latest updates from our immunology pipeline, aligned with Belén's strategic review, which she will discuss in more detail later. In dermatology, the ESTUARY phase III 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's sarcoma. We've decided not to progress to global regulatory submission as part of an ongoing strategic assessment of the pipeline. Turning now to duvakitug. We plan to initiate two phase II 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 balinatunfib programs after phase II studies in Crohn's disease and ulcerative colitis did not meet our internal efficacy expectations. Now with rare diseases on slide 21.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

At ATS, we presented new phase II data for efdoralprin alfa in AATD emphysema, demonstrating superiority over standard of care in achieving and maintaining normalized functional AAT levels. Dosed every three weeks, efdoralprin alfa 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 III 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.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

These data will support our discussions with the FDA on a potential label expansion, specifically in the U.S., as approvals were already secured elsewhere. Finally, as mentioned earlier, we are pleased that venglustat received U.S. 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 CirCLIQ 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.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

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 III readout for Sarclisa in transplant-eligible multiple myeloma that will result in another U.S. label expansion. Next year, we expect phase II-B results for brivekimig and hidradenitis suppurativa, followed by several phase III readouts, including frexalimab in relapsing multiple sclerosis, riliprubart in CIDP compared to IVIG, and our pneumococcal and yellow fever vaccines.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

In 2028, we expect multiple phase III readouts for Wayrilz 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 in 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 I in the second quarter, with internal projects to follow in due course. This year alone, we plan approximately one new phase I start every two months, a meaningful step up as the changes in research take flight.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

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, CEO at Sanofi]

Thank you so much, Mike. 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 sense of urgency in order to deliver a strategy that improves the perspective of the mid and long-term growth. 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 engage with company leaders, and I took these opportunities to take the temperature of the organization as well as to share my own expectations.

[Belén Garijo, CEO at Sanofi]

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 U.S., 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, a stronger, even if linear, governance, and more effective operations. We also need to strike the right balance between internal and external innovation in order to improve our productivity.

[Belén Garijo, CEO at Sanofi]

That is why I launched very early a comprehensive outside-in portfolio review, which will inform decisions on our pipeline, now focused on the later stage pipeline, some of which we shared last week and earlier today. When it comes to business, our ability to deliver commercial results in the U.S. and Europe, as demonstrated by this strong Q2 performance, is a key strength. We can also capitalize on our local footprint in a de-globalizing market, one with greater accountability, and empower country leadership, which will contribute to de-complexify the organization and eventually allow us to move with more agility. Overall, what is clear to me is that Sanofi has core strengths, it will now be the disciplined choices that we make that will define our next chapter.

[Belén Garijo, CEO at Sanofi]

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 Paulo Fontoura, an accomplished physician scientist and highly respected leader to head up R&D. Paulo is scientifically rigorous and has a proven track record of leading large global organizations and advancing innovative pipeline. Paulo 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.

[Belén Garijo, CEO at Sanofi]

On science, we have moved fast, making decisions on amlitelimab, as we communicated a few days ago, itepekimab, and balinatunfib, as Mike mentioned, as well as duvakitug, 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 Paulo's leadership. We are not going to wait for a minute, we are already engaging into the early phases of the R&D transformation, starting, as I mentioned, with the R&D, with the late-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.

[Belén Garijo, CEO at Sanofi]

On the business, we remain committed to immunology, rare diseases, and vaccines, 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 U.S. and Europe. We will continue to develop in Japan, we intend to expand our presence in China. You may have seen, we have nominated Thomas Triomphe, 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 a strategic importance for Sanofi.

[Belén Garijo, CEO at 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. 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, 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.

[Belén Garijo, CEO at Sanofi]

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 lead in 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, 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.

[Belén Garijo, CEO at Sanofi]

Sanofi has strengths, opportunities, and also challenges. What we need is focused decision-making, discipline, and executing with a sense of urgency. 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. Now, over to Thomas.

[Thomas Kudsk Larsen, Head of Investor Relations at Sanofi]

Thank you, Belén. 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. Option 2, submit your question by clicking the Q&A icon at the bottom of the screen. Then we'll read out your question. Then with that, I'll hand over to Marie, who will take the first question.

[Operator]

Yes. The first question is from James Quigley from Goldman Sachs. James?

[James Quigley, Analyst at Goldman Sachs]

Great. Thank you for taking my question. I've got two, please. Firstly, Belén, on the Regeneron alliance, you've got the benefit of being external to the history of the alliance, and a fresh perspective. Can you give us an idea of, from your point of view, what are the key factors that may have been blocking faster progress here in terms of adding assets into the collaboration? 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? Secondly, on R&D strategy, you highlighted accelerating the R&D transformation is key. What are the key priorities that you have for Paulo as he comes into the seat? Similarly, will he have additional resources here?

[James Quigley, Analyst at Goldman Sachs]

Sanofi's R&D to sales ratio is still at the bottom end of the sector. Is it a case of how much you spend versus where you spend it? Any thoughts there would be great. Thank you.

[Belén Garijo, CEO at Sanofi]

Hi, James. Thank you very much for your question. 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 environment in which we have been operating. 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.

[Belén Garijo, CEO at Sanofi]

We speak quite often while I will refrain myself from making any commitment on timing, as I mentioned, the conversations I feel are productive. We will further disclose to you whenever an agreement is reached in the future. Manuela, do you want to add anything?

[Manuela Buxo, EVP and Head of Specialty Care at Sanofi]

Perfect. No.

[Belén Garijo, CEO at Sanofi]

On the R&D spend and where to spend. Look, 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. 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. 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. I don't know, François, you want to add anything?

[François Roger, CFO at Sanofi]

No.

[Belén Garijo, CEO at Sanofi]

To this question?

[François Roger, CFO at Sanofi]

No, I think our investments are driven by contribution to growth and returns over time. This is what will drive our choices, be it in R&D or in the commercial side and industrial side as well.

[Operator]

Next question is from Sachin Jain from BofA. Sachin?

[Sachin Jain, Analyst at BofA]

Hi there. Sachin Jain, Bank of America, Belén, good to connect again. Just a couple of questions. Firstly, on M&A, you referenced disciplined licensing and BD.

[Sachin Jain, Analyst at BofA]

I wonder if you could talk about size of deals you're thinking about within your diagnosis as a conclusion that a larger single deal is required or multiple smaller. Just trying to get a sense of, in your early days, how much you've changed from Sanofi's recent BD strategy. 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? I just had clarifications to the prior answers. Regeneron, you call out trust, which is interesting given this litigation ongoing between the two companies on Dupixent, litigation on the rebates, which is in early stages. Does resolution of that influence the timing of any progress? On R&D, when you say moderate, could I just clarify, is that in line, or could R&D grow faster than sales? Thank you.

[Belén Garijo, CEO at Sanofi]

Let me start by your first question, which is size of the deals, and I will quote François during one of our conversations today. Traditionally, Sanofi has been on smaller deals, bolt-ons, to eventually increase innovation of fill gaps. I think our appetite for bigger deals is an option. 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. Yes, today we are open to eventually consider bigger deals. Rare and China, not exclusively. We are looking at our disease area strategy. Forget about looking at this as immunology and inflammation. We are looking at the disease area level. Where are we strong? We are strong in dermatology, and respiratory.

[Belén Garijo, CEO at Sanofi]

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, and now we have to catch up and benefit from the wave of innovation that is emerging in China. 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.

[Belén Garijo, CEO at Sanofi]

Our current focus is, two Dupixent, three Dupixent, and of course, identifying opportunities to work better together. This is something that requires a dynamic conversation, and of course, us being the commercial lead and then being the development lead, after many years, requires some small refinements. This is the focusing that we have today. If you specifically want anything on the litigation, Manuela, please.

[Manuela Buxo, EVP and Head of Specialty Care at Sanofi]

Just briefly, first of all, the litigation focuses on a narrow issue concerning information sharing. 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, in the meantime, we're having really productive discussions, frequent discussions, as Belén has shared. We will continue those discussions. 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. Then really continuing our productive conversations. This is what we're focusing on, and this is where we put our energy.

[François Roger, CFO at Sanofi]

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. We need to make our M&A and BD strategy evolve a little bit. 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. 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 and where we need to adapt as well to whatever is available.

[François Roger, CFO at Sanofi]

We are certainly, BD and M&A 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. We are not focusing on a given amount, for example, but more on the strategic, scientific, and financial relevance of what we do. You ask a question about the R&D as well. Is it going to grow faster or in line with our sales?

[François Roger, CFO at Sanofi]

In the short term, anyway, given the challenges that we have and the decision that we have made lately, it will grow to a moderate level R&D, which means at a lower level than sales. As we grow over time and as we gain confidence in our capabilities as well, it will certainly increase.

[Operator]

Next question is from Peter Verdult from BNP Paribas Exane. Pete? Hello? Okay.

[Belén Garijo, CEO at Sanofi]

Peter, we don't hear you.

[Operator]

Yeah. Okay. Maybe we try the next one for now. Luisa from Berenberg.

[Peter Verdult, Analyst at BNP Paribas]

Hello?

[Operator]

Oh.

[Peter Verdult, Analyst at BNP Paribas]

Hello? Hello? Sorry, guys. A user error. Sorry. Peter Verdult here at BNP Paribas. Belén, welcome back. Just two questions. Firstly, for you, Belén, could you remind us how much of the EUR 10 billion R&D budget is discovery versus development? 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? 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. Secondly, and more quickly, just for François or Manuela, it's very rare that on Dupixent there's a 10% miss 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%-15% positive impact from either price or channel mix.

[Peter Verdult, Analyst at BNP Paribas]

Maybe François and Manuela, 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? Thank you.

[Belén Garijo, CEO at Sanofi]

Peter, I give you the high-level answer to the R&D budget. The majority of the R&D budget is clinical development. Mike?

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

Right. Thanks, Peter, 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. 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. The key for that is really how we use the capital allocation within the R&D organization.

[Belén Garijo, CEO at Sanofi]

Pete, on your second question, my immunology thoughts are related to the pipeline failures. I don't think it has to do with immunology, right? 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 II to phase III and get ready to engage a significant amount of capital, you really need to challenge whether or not your data in phase II are justifying the move to phase III, right? You're going to start by dreaming on a target product profile that is not based on rigorous assumptions. That's basically what we are going to change. This is nobody's fault.

[Belén Garijo, CEO at Sanofi]

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? I am expecting the scientists to make scientific decisions, right? I am expecting the scientists to make a judgment call whether the data that we have in phase II, and I am using this as an example, qualify the asset to go to phase III. Scientific rigor, diligence, focus on fact-based decision making. I repeat, this is what I believe may have contributed to some of the study's setbacks that we have seen lately. We are going to pay a very significant attention to the way we make these decisions, and where do we make these decisions.

[François Roger, CFO at Sanofi]

Pete, on the question on Dupixent, first of all, we don't disclose the breakdown between volume and price. 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. 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 growth to net, which did help a bit in the quarter, which is not something that we will see later in the year.

[François Roger, CFO at Sanofi]

Once again, 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, Manuela, you want to give some additional color on that?

[Manuela Buxo, EVP and Head of Specialty Care at Sanofi]

Yeah. Just a little bit of a brief add to what François has already said. Really driven by underlying demand. 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. Yes, there's fluctuation in the GTN. 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, the one-off GTN topic that François mentioned. 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.

[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 conclusion on the Regeneron collaboration is a barrier to moving forward on any business development and M&A? On the 2030, the various components of guidance there, just your levels of confidence. In particular, the pharma launch is now at EUR 10 billion. Could you tell us anything more on the split there? It sounds like that is majority in-market products. For any pipeline contribution, what is the average risk adjustment applied? Any color on the profitability of that EUR 10 billion versus the prior guidance?

[Belén Garijo, CEO at Sanofi]

Thank you, Luisa. I'm going to take the first question, which is very straightforward to answer. We have, at this time, no barriers related to Regeneron to moving forward on M&A. On the pharma launches, François?

[François Roger, CFO at Sanofi]

The scope that we disclose does not include vaccines, by the way. If we look at it, because we don't duplicate, we have it as a separate guidance. If we look at it on this scope of the new launches, we will probably reach EUR 5.2 billion-EUR 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 AYVAKIT last year, we were growing in H1 at about 27%. To get to the EUR 10 billion by 2030, we need to move 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 EUR 10 billion.

[François Roger, CFO at Sanofi]

We are just talking of, by the way, all of these products are already in the market, so it's essentially 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 BOI, which is quite remarkable, due to the fact that we are really in an investment position behind these products to support the growth. They're already profitable and attractive from a profitability point of view as well.

[Operator]

The next question will be from Graham Parry from Citi. Graham?

[Graham Parry, Analyst at Citi]

Great. Thanks. Thank you for your questions. Just 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? In particular, if you were to go it alone, can you talk about the dynamics of sales force allocation between the alliance and Sanofi standalone, and would that be a barrier to being able to do immunology assets alone? Secondly, on R&D, Sanofi's been through many iterations of attempting to improve the pipeline. This is, I think, the third CEO in my coverage I've seen come in and with a new plan that sounds suspiciously like the old plan.

[Graham Parry, Analyst at Citi]

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, CEO at Sanofi]

Let me reply very briefly to question number one. 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 a bit more?

[Manuela Buxo, EVP and Head of Specialty Care at Sanofi]

Yeah, no, I would just add, Graham, that as Belén said earlier, immunology is a large space. Even dermatology and respiratory, we are looking at opportunities within the alliance, we're looking at opportunities outside of the alliance. 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. Both are options that we are currently actively reviewing as part of the strategic review that's ongoing.

[Belén Garijo, CEO at Sanofi]

Graham, I am not exactly sure what you mean that the pipeline plan sounds old. I assume that you mean that the R&D productivity issues of Sanofi have gone on for quite a while, right? 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, the term around R&D productivity takes a bit of time. 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.

[Belén Garijo, CEO at Sanofi]

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.

[Operator]

The next question is from Simon Baker from Redburn. Simon?

[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. 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. What sort of timeframe would you put on this? I'm assuming that Paulo's arrival is not a year zero event. There was a lot of restructuring under Houman, so where are we in that transformation journey? 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. We know you have a lot of IP beyond March 31 out to 2045, I think.

[Simon Baker, Analyst at Redburn]

It'd be interesting to get your early perspectives on what you think, as a fresh pair of eyes on this, is what you think the strength of the IP beyond 2031 is for Dupixent, and therefore, the more realistic possibilities, on when we will face biosimilar competition for that asset. Thanks so much.

[Belén Garijo, CEO at Sanofi]

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, or if not a significant number of setbacks, are operational risk. Fixing operation is a bit faster than recruiting expert capabilities to the organization. As Mike mentioned, our research efforts are already paying back. I am not saying that this is going to be fast, right? Starting by managing the operational risk actually would be a very good start. This is what we are going to do by prioritizing, acting, and deciding on scientific rigor, having the right of the 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.

[Belén Garijo, CEO at Sanofi]

Once again, we are not counting that this is going to be fast, 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 Papatheodorou, EVP and General Counsel and Head of Legal, Ethics & Business Integrity at Sanofi]

Thanks, Simon. First of all, you mentioned patents going to 2045. Actually, this quarter, we can say its patent expiration date's going up to 2046. We have a very strong patent portfolio around Dupixent. Many years of R&D, multiple innovations, nine indications to date, 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.

[Roy Papatheodorou, EVP and General Counsel and Head of Legal, Ethics & Business Integrity at Sanofi]

Rest assured that we have done our best to make sure that the years of innovation are being protected, we intend to really fight it out.

[Belén Garijo, CEO at Sanofi]

What I can tell you, Simon, is that we are taking a base case that is associated to the loss of the product patent.

[Operator]

The next question is from David Risinger from Leerink. David?

[David Risinger, Analyst at Leerink]

Yes, thanks very much, and congratulations, Belén, on your new role, and thank you for your comments today. Beyond Dupixent target increases longer term, could you please discuss what investors may be under-appreciating about Sanofi's future prospects? 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, CEO at Sanofi]

Thank you, David. First of all, I believe during my conversation with investors What I learned is that perhaps we have, for a period of time, overpromised and under-delivered. That's the bottom line, and this basically hit our credibility tremendously. 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. 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 Roger, CFO at Sanofi]

Maybe let me add something. I think 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. We tick the box fully on that because we have one of the highest level 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. I think that we are all working here in this organization in order to not only talk, but to execute and act, which we will see certainly in the coming months.

[Belén Garijo, CEO at Sanofi]

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 Peter Verdult on a transition between phase II and phase III, which is a very critical decision. 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.

[Operator]

The next question will be from Seamus Fernandez from Guggenheim. Seamus?

[Seamus Fernandez, Analyst at Guggenheim]

Thanks very much for the questions. 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 sort of management, rare disease, and then also, I think your comments on China are interesting. 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.

[Seamus Fernandez, Analyst at Guggenheim]

AAT is a very interesting incremental opportunity, just interested to understand how you're thinking about staying concentrated in those areas or perhaps broadening. 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? Thanks.

[Belén Garijo, CEO at Sanofi]

Thank you very much. I hear echo. Do you hear me? Yes, you hear me? It's okay. Rare. Yes. In rare, I believe we have an opportunity, first because the scope is broad, 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, I believe this presents an opportunity, it's giving us and giving our business significant resilience. I think on China is both. The market is attractive simply because the population is extremely big. Even if the pricing environment is very different than in other countries, the volumes that you can draw from China-specific indications or diseases is attractive, right? That is one element of it.

[Belén Garijo, CEO at Sanofi]

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.

[Operator]

The next question is from Michael Leuchten from Jefferies. Michael?

[Michael Leuchten, Analyst at Jefferies]

Thank you very much. Two questions, please, around the ExCom changes, Belén. One, obviously, you're kind of an outsider with prior experience, and you've brought in Paulo as an outsider. The rest of the ExCom change is really internal candidates. Can you talk about the pluses and minuses of not having more new blood in that ExCom to really effect a change? You made a very strong point about this being a big job and requiring really drastic changes. A similar question, not similar, but 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, CEO at Sanofi]

Michael, thank you for your question. On the ComEx changes, look, I go externally when I believe that it's necessary to search for a more transformative position, right? 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 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. A leader in Vaccines, who is now going to take General Medicines, and that makes a lot of sense because General Medicines is a Sanofi-specific business. Over the years, I have learned that you always take less risk when you source from internal talent than going outside.

[Belén Garijo, CEO at Sanofi]

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. There is a significant percentage of the ComEx out. Now we are eight, three are new ComEx members. It's a significant percentage with new eyes. With this, I hand it over of new blood, as you call it.

[François Roger, CFO at Sanofi]

On Michael, on BD, first and foremost, I'm aware of the responsibility that comes with it. I think, and second, we have been very successful in BD and in M&A. Just to give you some perspective, globally between BD and M&A, we invested EUR 47 billion over the last eight years, and we have lost EUR 7 billion. Sorry for the EUR 7 billion, but if we had not lost anything, we would not probably have taken the right level of risk. We have created quite a substantial value historically with the remaining EUR 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. We have a good track record both in BD and in M&A.

[François Roger, CFO at Sanofi]

I'm honored as well 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. What I insist upon as well is that BD is not necessarily, unnaturally within finance in many organization 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 is to make sure that even if it sits within my scope of responsibility, and especially for BD, less obviously for M&A, it will work only if we are super close to the R&D organization.

[Operator]

The next question is from Richard Vosser from JPMorgan. Richard?

[Richard Vosser, Analyst at JPMorgan]

Hi, thanks for taking my questions. Just a couple, please. 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 Paulo joins? On that remaining pipeline, there are a couple of phase III assets that read out in the coming 12 months, frexalimab and riliprubart. Apologies for the pronunciation, never going to get it. There's some discussion around the chances of success on both. On frexalimab, there's been discussion on the primary endpoint in phase III and the ability to beat AUBAGIO. Just interested in your thoughts and Michael's thoughts there. On riliprubart, the MOBILIZE trial failed, obviously. What are the learnings for that for the VITALIZE trial? Are you comfortable that the patient population enroll will be responsive to the drug? Thanks very much.

[Belén Garijo, CEO at Sanofi]

Thank you, Richard. The pipeline review is ongoing, I'm not excluding that we discontinue some additional assets. 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. At the end, after a thorough review of our pipeline, we will be once again concentrating our resources, this is the bottom line. We will be concentrating our resources in those with highest scientific merit, highest unmet medical need, and highest potential. On frexalimab, do you want to comment, Mike?

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

Happy to, Belén. Thank you for the question, Richard. On frexalimab, in the context of the phase III, 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. 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.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

What I'd say, what we put out, was that the IDMC recommended not moving forward in the context of the MOBILIZE study because we were unlikely to meet the primary endpoint. What I can say is that the two patient populations between the two studies are very different. 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. That comparison versus IVIG in that patient population is where we're looking at in VITALIZE. Importantly, what I can also add is the IDMC looked also at VITALIZE and recommended progressing VITALIZE forward.

[Mike Quigley, Chief Scientific Officer and Global Head of Research at Sanofi]

We have hope and we're on track to continue to read that out in the latter half of 2027.

[Operator]

The next question is from Matthew Weston from UBS. Matt.

[Matthew Weston, Analyst at UBS]

Thank you very much. Belén, a warm welcome back. My first question's for Manuela, it comes back to Pete's question on DUPI Gross to Net. Can I push you on your operational effectiveness comment? Has the alliance changed its policy on 340B claims for DUPI to reduce access to heavily discounted drug? 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. I guess if that is the case, why won't that trend continue? Why shouldn't Dupixent be able to deliver stronger than is suggested by the 10% total revenue guide that we've increased to? My second question is about the long-term guidance for vaccines. You bought Dynavax, but you cut the 2030 vaccine guide by 10% to EUR 9 billion.

[Matthew Weston, Analyst at UBS]

I know that some of that is FX, is it because you're meaningfully more cautious on Beyfortus, or is it the flu franchise, or is it something else?

[Manuela Buxo, EVP and Head of Specialty Care at Sanofi]

Thank you. Thank you, Matt, for that question. When we talk about operational improvements, operational effectiveness, fully agree that it is linked to 340B, partially. 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. There we've been, thanks to the team, successful. You're right, some of that will continue to occur also in the second half.

[Manuela Buxo, EVP and Head of Specialty Care at Sanofi]

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. We now have a higher base that you're comparing us to. 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.

[Belén Garijo, CEO at Sanofi]

Thomas?

[Thomas Triomphe, EVP Vaccines at Sanofi]

Regarding the second question, hello, Matthew. Thomas speaking. 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, way before the change of administration. When we look at the drivers of this EUR 1 billion difference for 2030 is coming on one half of it from a U.S. exchange rate, so U.S. to EUR, it's pure financial exchange rate. The second half is driven mostly by U.S. VCR, so U.S. VCR evolution, which has turned out to be weaker than expected following the new U.S. administration. Indeed, it's mostly into the respiratory area, so classical flu and RSV.

[Thomas Triomphe, EVP Vaccines at Sanofi]

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. If you put both together, that explains the difference. 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. Indeed, we wanted to recalibrate what has changed with the latest both exchange rate and U.S. overall, I would say, policy.

[Operator]

The next question is from Florent Cespedes from Oddo. Florent?

[Florent Cespedes, Equity Analyst at Oddo BHF]

Good afternoon. Florent Cespedes 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 products in the pipeline. I understand that the portfolio review is ongoing, do you have some projects remaining in the pipeline where you have strong confidence and

[Florent Cespedes, Equity Analyst at Oddo BHF]

Be 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, CEO at Sanofi]

Hi, Florent. Listen, of course, as we prioritize our assets, confronting stage of development versus potential, understanding of the biology versus pace of development, et cetera. You get a picture that classifies those assets into most promising, less promising, and in the middle of it, right? I think it's too soon to tell you where are we going to land with the strategic review. I think Mike has highlighted some of the successes on the quarter, and also has spoken a bit of the outlook towards next year. I will remain very prudent until I see more data, and obviously, once we have those solid data that we need to see, we will come back to you to tell you.

[Belén Garijo, CEO at Sanofi]

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 DRM, we are expecting to give you a broader perspective on where are we on the strategy and the pipeline. On China, the question goes for Thomas.

[Thomas Triomphe, EVP Vaccines at Sanofi]

Happy to say a few words. Thanks, Florent. Don't expect today a big new reveal of a new strategy for China as I'm starting September 1st. However, I think a couple of things I'd like to highlight. As previously mentioned by Belén, obviously, China has revealed to be, over the past few years, an extraordinary source of innovation with the speed and the ecosystem associated to it being really interesting. We want to double down on our efforts there. We started some, and we want to accelerate on this. Indeed, alternatively, if you look also at the China local pharmaceutical marketplace, it's also a very interesting marketplace. First and foremost, because it's a very competitive one. I'm pretty sure we can learn a lot of things from China that will also be very important in the long term for this organization moving forward. Excited by both aspects.

[Thomas Triomphe, EVP Vaccines at Sanofi]

What I want to highlight, of course, is that this can only be done in extremely close collaboration first, with R&D when it comes to innovation. Extremely looking forward to work further with Paulo and Mike on this journey. Of course, for the competitiveness of the overall market, it's going to be a transversal effort with all the ExCom to be able in China to be as competitive as we can.

[Operator]

The last question will be from James Gordon from Barclays. James.

[James Gordon, Analyst at Barclays]

Hello, 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 area? 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? 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"? 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?

[James Gordon, Analyst at Barclays]

The second question was just about spend. We've heard that you think you might need to do a bit more R&D, is there anywhere that you might not need to spend quite so much? 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? 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, CEO at Sanofi]

Let me start with the Regeneron question. As I mentioned, it's a combination of looking at options to eventually expand the alliance with assets from both sides, right? In parallel, looking at potential improvements to the collaboration to be more agile and to bring more transparency to the way we operate. Of course, as for any other partnership, as I mentioned before, an ongoing development of trust. 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. On M&A, to be honest, it's a matter of opportunity, but you can count that It will be a combination of a strategic fit.

[Belén Garijo, CEO at Sanofi]

We will likely focus on our pillars, on our main pillars, on our core pillars. 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 late 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 Roger, CFO at Sanofi]

Yeah, I can take that one, James. 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. 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 on, I would rather talk of investment rather than spend, are driven by contribution to growth and contribution to return. If there is a better return on the commercial side of things, that's what we will do. We don't manage fixed budget within a certain category of investments.

[François Roger, CFO at Sanofi]

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 General Medicines, 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 our impressive almost 18% growth in Q2. Once again, this is driven. Our choices on cost allocation and investment allocation are driven by contribution to growth and returns.

[Belén Garijo, CEO at Sanofi]

Okay. This was our last question. I wanted to thank everybody for your interest in Sanofi, and I look forward to continue the very interesting conversation that we have initiated today. Thank you very much

Participants

Executives

• Thomas Kudsk Larsen, Head of Investor Relations
• Belén Garijo, CEO
• François Roger, CFO
• Mike Quigley, Chief Scientific Officer and Global Head of Research
• Manuela Buxo, EVP and Head of Specialty Care
• Roy Papatheodorou, EVP and General Counsel and Head of Legal, Ethics & Business Integrity
• Thomas Triomphe, EVP Vaccines

Analysts

• James Quigley, Analyst at Goldman Sachs
• Sachin Jain, Analyst at BofA
• Peter Verdult, Analyst at BNP Paribas
• Luisa Hector, Analyst at Berenberg
• Graham Parry, Analyst at Citi
• Simon Baker, Analyst at Redburn
• David Risinger, Analyst at Leerink
• Seamus Fernandez, Analyst at Guggenheim
• Michael Leuchten, Analyst at Jefferies
• Richard Vosser, Analyst at JPMorgan
• Matthew Weston, Analyst at UBS
• Florent Cespedes, Equity Analyst at Oddo BHF
• James Gordon, Analyst at Barclays