Q2 2026 Sanofi SA Earnings Call

July 30, 2026

Thomas Triomphe: Welcome to the Q2 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.

Speaker #1: Welcome to the second quarter 2026 conference call for investors and analysts. A live stream can be found on sanofi.com. Please turn to slide number 3. 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 uncertainty that may cause actual results to differ materially.

Speaker #1: 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.

Thomas Triomphe: 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 are 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 Q2, unless we stated otherwise. Please turn to slide number four. Here is the agenda for today. We are welcoming Belén for the first quarterly conference call since joining Sanofi.

Speaker #1: 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 stated otherwise.

Thomas Triomphe: Numbers used are in millions of EUR, and for the Q2, unless we stated otherwise. Please turn to slide number four. Here is the agenda for today. We are welcoming Belén for the first quarterly conference call since joining Sanofi.

Speaker #1: Please turn to slide number 4. Here is the agenda for today. We are welcoming Berlin for the first quarterly conference call since joining Sanofi.

Speaker #1: Berlin 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.

Thomas Triomphe: Belén will cover our business and her first reflections as a new CEO. You will also hear from our CFO, François, and our head of research, Mike, on the pipeline. We have 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.

Speaker #1: 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.

Speaker #1: 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 Berlin.

Speaker #2: 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 improvements and lead the organization in its next phase of growth.

Belén Garijo: Thank you, Thomas. Welcome, everybody, also from my side. As you can imagine, I am excited to return to Sanofi, ready to drive the necessary improvement and lead the organization in this next phase of growth. I am also looking forward to reconnecting with all of you on this call 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.

Speaker #2: 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.

Speaker #2: We have already started translating those conclusions into decisions and, importantly, into near-term priorities. Our teams continue to deliver quarter-over-quarter, as seen by the results.

Speaker #2: At the same time, I have to fully recognize the challenges confronting us and the need to build a strategy that delivers on mid- and long-term growth.

Speaker #2: 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.

Belén Garijo: 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.

Speaker #2: 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. François will provide additional detail around this transitioning.

Speaker #2: Let's move to slide number 6 to go through our quarterly results. In Q2, we continued to deliver very strong growth, with a double-digit sales increase driven by both pharma launches and the continued strength of Topexen.

Belén Garijo: Sales on our pharma launches were up by nearly 50%, led by VYVGART, 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 Flublok 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.

Speaker #2: Sales from our pharma launches were up by nearly 50%, led by Ivakit, Altuvio, and Sartlisa. Established medicines were stable in the quarter. Topexen continued its very strong growth, up 37% in Q2, and that was driven largely by volume; that means more patients receiving it.

Speaker #2: Vaccines declined slightly, mainly impacted by a high comparable from last year's influenza sales, and that was offset by solid Beyfortus and Epizyme B performance.

Speaker #2: Overall, we saw good momentum across our portfolio, and we are confident in our growth trajectory. Turning to recent launches on slide number 7, our launch portfolio is a key growth driver.

Speaker #2: These medicines already represent 13% of our sales and grew over 60% in Q2. Let me walk you through the key contributors. Altuvio continued its strong momentum in hemophilia A and remains the top choice for patient switches in the US.

Speaker #2: Ivakid continues to expand in systemic mastocytosis, driven by continued growth in the number of patients treated and the 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.

Belén Garijo: VYVGART 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 Flublok vaccine, one of our latest additions, and the recently launched rare disease medicines, WAYLIVRA and Nexviazyme, 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, we expect this portfolio to continue driving meaningful growth. Turning to immunology on slide number eight.

Speaker #2: We saw a significant contribution from the Epliza B vaccine, one of our latest additions, and the recently launched rare disease medicines Weyrilds and Tufitlia are starting to show momentum.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Turning to immunology, on slide number 8. Dupixent has more than 15 million patients currently under treatment globally, and sales exceeded €5 billion in the quarter for the first time.

Belén Garijo: DUPIXENT has more than 1.5 million patients currently under treatment globally, and sales exceeded EUR 5 billion in the quarter for the first time. Growth was driven by robust demand across indication and geographies. The US 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 H2 of the year as newly launched indications annualize and comparables become established. 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 EUR 25 billion sales, a reflection of the continued strong momentum. Turning to rare diseases on slide number nine.

Speaker #2: 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, which François will also detail.

Speaker #2: 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 tighter.

Speaker #2: 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.

Speaker #2: Therefore, we have upgraded our 2030 ambition for Dupixent to around €25 billion in sales, a reflection of the continued strong momentum. Turning to rare diseases on slide number 9.

Speaker #2: 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, up by 24%, and this is driven by Altuviio and Iqirvo.

Belén Garijo: 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 VYVGART 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 JAK/ROCK 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.

Speaker #2: 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.

Speaker #2: MyKorso, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy, and Robavistinib, the first drug jack 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.

Speaker #2: Moving to vaccines. On slide number 10, on vaccines, sales reached €1.15 billion in the second quarter, 5% lower than last year. And this reflects the high 2025 comparison base in influenza.

Belén Garijo: Vaccine sales reached EUR 1.15 billion in Q2, 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 US season and continued geographic expansion. Second, Fluzone 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 Fluzone B shows the resilience of our vaccines franchise. Moving to slide 11. Let me speak a bit about our Sanofi Global Health Unit.

Speaker #2: 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.

Speaker #2: First, Befortus sales grew by 54% to €108 million, driven by a late US season and continued geographic expansion. Second, Epliza-B grew by 43% on a pro forma basis to €113 million, offsetting the expected impact of birth cohort dynamics of the pediatric franchise.

Speaker #2: Overall, the performance of Beyfortus and Epliza B shows the resilience of our Vaccines franchise. Moving to slide number 11, let me speak a bit about our Sanofi Global Health unit.

Speaker #2: 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.

Belén Garijo: 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 nonprofit brand of WHO essential medicines, our medicines are now available in 30 underserved countries. It is a major milestone on our journey to reach 2 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 million 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.

Speaker #2: 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.

Speaker #2: But 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.

Speaker #2: Through 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.

Speaker #2: 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 Françoise, our CFO, for more details on our financials.

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

Speaker #1: Thank you, Belen, and hello everyone. Starting with slide 13, which is illustrating our strong growth: Q2 net sales grew 17.8% to €11.6 billion.

François-Xavier Roger: Thank you, Belén, and 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 million of positive adjustments in growth to net. DUPIXENT saw strong and continued patient adoptions, and our launches continued 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's 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.

Speaker #1: This growth was primarily volume-driven, and included as well a couple of hundred million of positive adjustments in gross-to-net. Dupixent's 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%.

Speaker #1: Our gross margin increased by 3.7 percentage points. This improvement benefited from the reversal of inventory provisions following Sarclisa Sub-Q 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.

Speaker #1: 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.

Speaker #1: 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 higher this quarter compared to last year.

François-Xavier Roger: 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 growth 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. Now 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. We anticipate some deceleration of our sales growth.

Speaker #1: 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 was 21%, supported by solid operational leverage.

Speaker #1: Now, turning to H1, sales growth was 15.7%, and business EPS was up 22.7%, partly driven by the impact of acquisitions as far as sales growth is concerned, and by positive one-offs for EPS.

Speaker #1: 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 momentum from last year, from Dupixent's new indication, as well as the consolidation of Evkeeza, which began in July 2025.

François-Xavier Roger: Indeed, we will lap in H2 against a strong set of momentum last year from DUPIXENT's new indication, as well as the consolidation of EVKEEZA, 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. 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

François-Xavier Roger: 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 of 2026, the increase of Amgen royalties will fully offset this negative BOI impact. Next year in 2027, we will see a EUR -200 million BOI gap between these two items. Indeed, we expect a final BOI impact of EUR -600 million year on year from 2026 to 2027 from the Regeneron reimbursement, while Amgen 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 Amgen royalty projections until 2030 based on Vara consensus.

Speaker #1: Q2 marks the end of the Regeneron development balance reimbursement. For the full year 2026, the increase of Ambutra royalties will fully offset this negative BOI impact.

Speaker #1: Next year, in 2027, we will see a negative €200 million BOI gap between these two items. Indeed, we expect a final negative BOI impact from the Regeneron reimbursement of about €600 million year on year, from 2026 to 2027, while Ambutra royalties income is expected to increase at the same time by about €400 million year on year as well.

Speaker #1: We are also introducing, on the right side of the slide, the Ambutra royalty projections until 2030, based on Vara consensus. We take note of recent competitor data, which supports our confidence in the long-term potential of this medicine.

François-Xavier Roger: 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 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.

Speaker #1: Slide 17: We are upgrading our 2026 guidance to reflect strong business momentum today. We now expect sales growth of around 10% at constant exchange rates, with business EPS growing slightly faster than sales.

Speaker #1: Before concluding, I also want to update our 2020 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.

Speaker #1: 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.

François-Xavier Roger: With that context in mind, I'm pleased to confirm that we are upgrading our sales ambition for these 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.

Speaker #1: We raised our Dupixent sales ambition for 2030, which is now expected to reach about €25 billion, driven by growth across all indications. Our ambitions for pharmaceutical launches remain unchanged and should generate about €10 billion in sales, reflecting the strength and diversity of our launch portfolio.

Speaker #1: And finally, our vaccine business is expected to reach about €9 billion in sales, thanks to our differentiated portfolio and innovation. The €1 billion reduction is split equally between a currency impact and market dynamics.

Speaker #1: These ambitions reflect our strong commercial capabilities. Let me now hand over to Mike to cover the pipeline section.

Speaker #2: 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.

Mike Quigley: 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 the 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 WAYLIVRA in Japan for immune thrombocytopenia. SARCLISA also became the first anti-cancer medicine approved in the US, 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.

Speaker #2: We're looking forward to welcoming Paolo in September. On slide 19 is a status update on recent pipeline news. Beginning with regulatory approvals, we received a US label expansion for Dupixent in chronic spontaneous urticaria in children.

Speaker #2: A U.S. label expansion for Tseild in stage 3, type 1 diabetes, and Wayrills in Japan for immune thrombocytopenia. Sarclisa also became the first anti-cancer medicine approved in the U.S., either subcutaneously or via an on-body injector.

Speaker #2: In addition, Sanrifki received EU approval for the treatment of secondary progressive multiple sclerosis in patients without relapses, representing an important advancement by addressing disability progression.

Speaker #2: 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, the second venglustat study in Fabry disease, and, really, Prubarc was stopped early in refractory CIDP based on an IDMC recommendation.

Mike Quigley: 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.

Speaker #2: While the Phase 3 in IVIG-treated patients remains on track, amlitelimab showed sustained response in the extension long-term study, although we subsequently decided not to progress to regulatory submission as part of an ongoing strategic assessment of the pipeline.

Speaker #2: Finally, Nexvisime 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.

Speaker #2: 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.

Mike Quigley: 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 brivekimig. 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 lunsekimab 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.

Speaker #2: Aligned with Belin'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.

Speaker #2: However, we've decided not to progress to global regulatory submission as part of an ongoing strategic assessment of the pipeline. Turning now to Devakatug, we plan to initiate two Phase 2 studies in hidradenitis suppurativa and in fibrostenotic Crohn's disease, complementing our focus in inflammatory bowel disease.

Speaker #2: We have discontinued Expecimab programs across COPD and chronic rhinosinusitis, and Belin Tumfed programs after Phase 2 studies in Crohn's disease and ulcerative colitis did not meet our internal efficacy expectations.

Speaker #2: Now with rare diseases, on slide 21. At ATS, we presented new Phase 2 data for Fdoroplen alpha in AATD emphysema, demonstrating superiority over standard of care in achieving and maintaining normalized functional AAT levels.

Mike Quigley: 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 3 weeks, efdoralprin alfa achieved mean functional AAT trough levels more than 3 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 H2. 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.

Speaker #2: Dosed every three weeks, Fdoroplen alpha achieved mean functional AAT trough levels more than three times higher than those observed with weekly plasma-derived AAT at week 32.

Speaker #2: 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.

Speaker #2: We also presented highly encouraging Phase 3 results for Nexvisime in infantile-onset Pompe disease, with 94% of infants alive and free from invasive ventilation at week 52.

Speaker #2: 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 U.S., as approvals were already secured elsewhere.

Mike Quigley: These data will support our discussions with the FDA on a potential label expansion, specifically in the US, as approvals were already secured elsewhere. Finally, as mentioned earlier, we are pleased that venglustat received US priority review for type 3 Gaucher disease with a target action date of 25 November. 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.

Speaker #2: And finally, as mentioned earlier, we are pleased that Venglicet received US Priority Review for Type 3 Gaucher disease, with a target action date of November 25.

Speaker #2: Moving to Oncology on slide 22. The Sarclisa subcutaneous formulation, including an on-body injector, is now approved in major markets across different lines of treatment in multiple myeloma.

Speaker #2: The Sarclisa CertClick 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.

Speaker #2: It was designed to enable potential at-home administration, either by a healthcare professional or by the patients themselves, where approved, and potentially support it by telemedicine.

Speaker #2: We are pleased with the regulatory approvals in major markets, and we 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.

Mike Quigley: 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 US label expansion. Next year, we expect phase II-B results for brivekimig in 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.

Speaker #2: 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.

Speaker #2: 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, which will result in another US label expansion.

Speaker #2: Next year, we expect Phase 2b results for Brevecimab in hidradenitis suppurativa, followed by several Phase 3 readouts including Frexalimab in relapsing multiple sclerosis, Prubarc in CITB compared to IVIG, and our pneumococcal and yellow fever vaccines.

Speaker #2: In 2028, we expect multiple Phase 3 readouts for Waverles in IgG4-related disease and warm autoimmune hemolytic anemia, as well as for Frexalimab in secondary progressive multiple sclerosis, and Sarclisa in smoldering multiple myeloma.

Mike Quigley: In 2028, we expect multiple phase III readouts for rilzabrutinib in 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 Q2, with internal projects to follow in due course. This year alone, we plan approximately one new phase I start every 2 months, a meaningful step up as the changes in research take flight.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Mike Quigley: 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. I'll hand the call back to Belén.

Speaker #2: 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.

Speaker #2: With that, I'll hand the call back to Belin.

Speaker #1: 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.

Belén Garijo: 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 comments 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 goals. 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.

Speaker #1: I had to fully acknowledge the challenges confronting us, and the need to act with a sense of urgency in order to deliver strategies that improve the perspective of mid- and long-term growth.

Speaker #1: 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.

Speaker #1: I am on slide 27. On people, through either town halls or country visits, I engage with company leaders and I took this opportunities to take the temperature of the organization as well as to share my own expectations.

Speaker #1: 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.

Belén Garijo: 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. 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.

Speaker #1: Going forward, I plan to build on this commitment to foster a performance-driven culture, greater accountability, and an ecosystem where people are empowered to make more agile decisions.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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 latest-stage pipeline, some of which we shared last week and earlier today.

Belén Garijo: 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 US 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, and it will now be the disciplined choices that we make that will define our next chapter.

Speaker #1: 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.

Speaker #1: We can also capitalize on our local footprint in a deglobalizing market—one with greater accountability and empowered country leadership—which will contribute to decomplexifying the organization and eventually allow us to move with more agility.

Speaker #1: 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.

Speaker #1: 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.

Belén Garijo: 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.

Speaker #1: 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 demands ahead, laying the foundation for our mid- and long-term roadmap.

Speaker #1: First of all, on people, we have appointed Paolo Funtura, 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 pipelines.

Speaker #1: 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.

Speaker #1: On science, we have moved fast, making decisions in a few days ago. It's a PECI map, and Marina Tupip, as Mike mentioned, as well as Dubakituk, were together with our partners. We have already defined the next two indications.

Belén Garijo: On science, we have moved fast, making decisions on amlitelimab, as we communicated a few days ago. Itepekimab, and lunsekimig, 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, and we are already engaging into the early phases of the R&D transformation, starting, as I mentioned, with the later-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.

Speaker #1: 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 in the early phases of the R&D transformation, starting, as I mentioned, with the latest-stage pipeline and strategic review.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Belén Garijo: 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. 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 talent. Let me talk about something which is very close to my heart. The alliance with Regeneron is of a strategic importance for Sanofi.

Speaker #1: 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.

Speaker #1: 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. You may have seen we have nominated Thomas Trump, head of vaccines, to lead China and our expansion there.

Speaker #1: Given the vibrant ecosystem and rapidly advancing science—combining decision-making with speed and agility—growing innovation policies, and exceptional talents, let me talk about something which is very close to my heart.

Speaker #1: 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.

Belén Garijo: 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, and that includes our commitment to the dividends and our dividend policy. Moving to slide number 29. Last but not least, from 1 September, 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.

Speaker #1: 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.

Speaker #1: I also see 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.

Speaker #1: Moving to slide number 29, last but not least, from September 1, to deliver on the priorities I outlined, we will have a more focused executive team.

Speaker #1: The members of the COMEX are experienced professionals who will work together and who will stand behind the strategic decisions of the company in order to shape our future direction.

Belén Garijo: We 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, 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.

Speaker #1: 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.

Speaker #1: 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 long term.

Speaker #1: We aim to engage with you on our strategic direction over the coming months, and at the 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.

Speaker #1: 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.

Belén Garijo: 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 to date 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.

Speaker #1: I want to take this opportunity to thank all the Sanofi colleagues I have met today, and those whom I will meet, because their openness, genuine feedback, passion, and commitment are absolutely invaluable.

Speaker #1: At closing, I want to thank you for your time before we come to the Q&A and now over to Thomas.

Speaker #2: Thank you, Belen. And I will 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.

Thomas Triomphe: 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 two, 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.

Speaker #2: There's also an opportunity tomorrow for many of you with the sales side meeting, and also investor meetings over the coming days. You'll be notified when your line is open to ask a question.

Speaker #2: At that time, please make sure you unmute your microphone. Option two, submit your question by clicking the Q&A icon at the bottom of the screen.

Speaker #2: And then we'll read out your question. With that, I'll hand over to Marie, who will take the first question.

Speaker #3: Yes. The first question is from James Quigley from Goldman Sachs. James?

Marie Lang: Yes, the first question is from James Quigley from Goldman Sachs. James?

Speaker #4: Great, thank you for taking my question. I've got two, please. Firstly, Belen, on the Regeneron alliance—you have the benefit of being external to the history of the alliance and can offer a fresh perspective.

James Quigley: 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 Paolo as he comes into the seat? Similarly, will he have additional resources here?

Speaker #4: So, can you give us an idea 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?

Speaker #4: And you say you're in the 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?

Speaker #4: And secondly, on R&D strategy, you highlighted that accelerating the R&D transformation is key. What are the key priorities you have for Paolo as he comes into the seat?

Speaker #4: Similarly, does will he have additional resources here? Sanofi's R&D 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?

James Quigley: Sanofi's R&D 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.

Speaker #4: Any thoughts there would be great. Thank you.

Speaker #3: 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.

Belén Garijo: Hi, James. Thank you very much for your question. My impression on the alliance is that, first of all, we have been extremely successful in driving DUPIXENT. 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. 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 be able to be transparent to one another, to be able to create a path forward for this conversation.

Speaker #3: To be honest, my initial impression is that, as with any partnership, trust is absolutely essential—and for different reasons that I'm not going to judge.

Speaker #3: I didn't have the feeling that this 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.

Speaker #3: To rebuild trust, to be able to be transparent with one another, and to be able to create a path forward for this conversation—I mean, we speak quite often. While I will refrain from making any commitment on timing, as I mentioned, I feel the conversations are productive and we will further disclose to you whenever an agreement is reached in the future.

Belén Garijo: We speak quite often, 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?

Speaker #3: Manuela, do you want to add anything?

Speaker #5: Perfect. No, please.

Manuela Buxo: Perfect. No, please.

Speaker #3: So, 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.

Belén Garijo: 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-

Speaker #3: And in that context, in the coming months and in the short term—let's put it that way—we are expecting to have moderate increases in our R&D spend.

Speaker #3: 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.

Speaker #3: So, I don't know, François, do you want to add anything to this question?

Speaker #2: No, I think our investments are driven by contribution to growth and returns over time. So, this is what will drive our choices.

François-Xavier Roger: No

Belén Garijo: to this question?

François-Xavier Roger: 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.

Speaker #2: Be it in R&D, or on the commercial and industrial sides as well.

Speaker #3: Next question is from Sachit Jain from BofA. Sachit?

Marie Lang: Next question is from Sachin Jain from BofA. Sachin?

Speaker #6: Hi there. Sachit Jain, Bank of America, and Belen, good to connect again. So just a couple of questions. Firstly, on M&A, you referenced disciplined licensing and BD.

Sachin Jain: 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. I wonder if you could talk about size of deals you're thinking about within your diagnosis as a conclusion, and a larger single deal if 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 the early stages.

Speaker #6: So I wonder if you could talk about size of deals you're thinking about within your diagnosis as a conclusion and a larger single deal is required on multiple smaller.

Speaker #6: I'm just trying to get a sense of, in your early days, how much has it changed from Sanofi's recent BD strategy. And then, regarding areas of initial focus—you called out both rare and China.

Speaker #6: Is that fair for us to think about as the initial focus, or could it be broader? And then, I just had a clarification to the prior answers.

Speaker #6: So, Regeneron—you call out trust, which is interesting given there is litigation ongoing between the two companies on Dupixent, specifically litigation on the rebates, which is in the early stages.

Speaker #6: Does resolution of that influence the timing of any progress? And then on R&D, when you say moderate, can I just clarify—is that in line, or could R&D grow faster than sales?

Sachin Jain: 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.

Speaker #6: Thank you.

Speaker #3: So let me start by answering your first question, which is the size of the deals. And I will put François on during one of our conversations today.

Belén Garijo: 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 read-ups. 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 3 pillars. Our strategic fit, the science, and the potential to deliver innovation, and, of course, our financial cut rates. I guess 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, right? And respiratory.

Speaker #3: So traditionally, Sanofi has focused on smaller deals—bolt-ons—to eventually increase innovation or fill gaps. I think our appetite for bigger deals is an option.

Speaker #3: 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.

Speaker #3: And of course, our financial guardrails. But yes, today we are open to eventually considering bigger deals. Rare and China, not exclusively—we are looking at our disease area strategies.

Speaker #3: 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, right?

Speaker #3: 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, right?

Belén Garijo: 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. Right? 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, and 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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, right?

Belén Garijo: Of course, identifying opportunities to work better together. Right? This is something that requires, it's a dynamic conversation. Of course, us being the commercial lead and them 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.

Speaker #3: This is something that requires—it's a dynamic conversation. And of course, as being the commercial lead and then being the development lead, after many years, requires some small refinements.

Speaker #3: And this is the focusing that we have today. But if you specifically want anything on the litigation, Manuela, please?

Speaker #5: Yeah. So, just briefly, first of all, the litigation focuses on a narrow issue concerning information sharing. And, as Belen 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.

Manuela Buxo: 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, and 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.

Speaker #5: Continuing to do that. And in the meantime, we're having really productive discussions—frequent discussions, as Belen has shared. And we will continue those discussions.

Speaker #5: 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.

Speaker #5: This is what we're focusing on, and this is where we put our energy.

Speaker #2: And so, Sachin, just to complement what Belen 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.

François-Xavier Roger: 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.

Speaker #2: So, we need to make our M&A and BD strategy evolve a little bit. As Belen said a few minutes ago, in the past, we've essentially focused on early-stage assets.

Speaker #2: 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.

Speaker #2: It's not one single deal. You mentioned that it could have different structures, and that we need to adapt as well to whatever is available.

Speaker #2: But we are certainly BD, and M&A will be a way to address the challenges that we are facing with our pipeline, even though the pipeline will not be able to address it with an immediate impact on our financials in the short term.

François-Xavier Roger: We are certainly, and 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 asked a question about the R&D as well. Is it going to grow faster or in line with our sales?

Speaker #2: It's less a matter of amount; it's more a matter of relevance, as Belen said earlier, in terms of fit with our strategy, as well as scientific relevance and financial returns.

Speaker #2: 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.

Speaker #2: Is it going to grow faster or in line with, 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.

François-Xavier Roger: 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 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.

Speaker #2: But as we grow over time and as we gain confidence in our capabilities as well, it will certainly increase.

Speaker #3: Next question is from Pete Verdult from BNP Paribas Exane. Pete? Hello? Okay.

Manuela Buxo: Next question is from Pete Verdult from BNP Paribas Exane. Pete? Hello? Okay. Peter, we don't hear you. Yeah. Okay. Maybe we try the next one for now. Riza from Berenberg.

Speaker #4: Peter, we don't hear you.

Speaker #3: Yeah. Okay. Maybe we try the next one for Berenberg? Oh, yes.

Speaker #2: Hello? Hello? Hello. Sorry. Sorry, guys. User error—sorry. Pete Verdult here, BNP Paribas. Belen, welcome back. Just two questions. Firstly, for you, Belen.

Peter Verdult: Hello?

Pete Verdult: Hello?

Manuela Buxo: Oh.

Peter Verdult: Hello? Hello? Sorry guys. A user error. Sorry. Pete 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, 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? 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% to 15% positive impact from either price or channel mix.

Pete Verdult: Hello? Hello? Sorry guys. A user error. Sorry. Pete 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, 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? 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% to 15% positive impact from either price or channel mix.

Speaker #2: 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 and development' at Sanofi?

Speaker #2: I'm 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.

Speaker #2: And then secondly, and more quickly, just for François or Manuela, it's very rare that on Dupixent there's a 10% miss from consensus between consensus and reported numbers.

Speaker #2: 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.

Speaker #2: So 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?

Peter Verdult: 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.

Pete Verdult: 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.

Speaker #2: Thank you.

Speaker #3: Peter, I'll give you the high-level answer to the R&D budget. The majority of the R&D budget is clinical development, Mike.

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

Speaker #2: Right. Thanks, Pete, for the question. Belen, 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 Belen's statement and the strategic review.

Mike Quigley: Right. 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 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 we 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.

Speaker #2: 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 rigorously, as Belen mentioned earlier, around what we continue to progress versus what we make sure we dynamically allocate away from—those medicines that aren’t promising.

Speaker #2: So the key for that is really how we use the capital allocation within the R&D organization.

Speaker #3: Pete, on your second question—my immunology thoughts related to the pipeline failures—I don't think it has to do with immunology, right? I mean, we have significant capabilities in that area, context, advisors.

Belén Garijo: Peter, on your second question, my immunology thoughts related to the pipeline failures. I don't think it has to do with immunology, right? We have significant capabilities in that area, context, 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 don't 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.

Speaker #3: 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 2 to Phase 3, and get ready to engage a significant—and get ready to engage a significant amount of capital, you really need to challenge whether or not your data in Phase 2 are justifying the move to Phase 3, right?

Speaker #3: And you don't start by dreaming of a target product profile that is not based on rigorous assumptions. So that's basically what we are going to change.

Speaker #3: And 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.

Belén Garijo: 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, or contributed to some of the studies' 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.

Speaker #3: Right? So I am expecting the scientists to make scientific decisions, right? And I am expecting the scientists to make a judgment call on whether the data that we have in phase 2—and I am using this as an example—qualify the asset to go to phase 3.

Speaker #3: So, scientific rigor, diligence, focus on fact-based decision-making. I repeat, this is what I believe may have contributed, or contributed to Sanofi studies' setbacks that we have seen lately, and we are going to pay very significant attention to the way we make these decisions and where we make these decisions.

Speaker #2: And Pete, on the question on Dupixent, so 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.

François-Xavier Roger: Pete, on 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 9 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 gross to net, which did help a bit in the quarter, which is not something that we will see later in the year. 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.

Speaker #2: So this is the 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.

Speaker #2: 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 the penetration of biologics across indications. Really, maybe Manuela, you want to give some additional color on that?

François-Xavier Roger: Maybe Manuela, you want to give some additional color on that.

Speaker #3: 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.

Manuela Buxo: 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, and then 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 H2 of the year.

Speaker #3: The total demand is higher than the script data. And yes, there's fluctuation in the GTN. We have also focused on operational effectiveness in the area of GTN to really make sure that all of our actions have the right intention and get to patients in the right way.

Speaker #3: That has also contributed. And then the one-off GTN topic that Francois mentioned, but it was really the vast majority was demand-driven and we expect that demand-driven growth to continue at a more moderated growth rate, moderate growth rate for the second half of the year.

Speaker #1: The next question is for Luisa Hector from Bernbank. Luisa?

Marie Lang: The next question is for Luisa Hector from Bernstein. Luisa?

Speaker #4: Thank you. Hi, and welcome, Belen. 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?

Luisa Hector: Thank you. Hi, 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 launches now at EUR 10 billion. Could you tell us anything more on the split there? It sounds like that is majority in-market product. 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?

Speaker #4: 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.

Speaker #4: Could you tell us anything more on the split there? It sounds like that is a majority of in-market products. But for any pipeline contribution, what is the average risk adjustment applied?

Speaker #4: And any color on the profitability of that $10 billion versus the prior guidance?

Speaker #3: 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.

Belén Garijo: 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?

Speaker #3: On the pharma launches, Francois?

Speaker #2: Yes, on the pharma launches—so, Luisa, the scope that we disclosed does not include vaccines, by the way. But if we look at it, because we don't duplicate, we have it as a separate guidance.

François-Xavier Roger: Yes. On the pharma launches, Luisa, 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 product like EVKEEZA 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.

Speaker #2: 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.

Speaker #2: If you look at the like-for-like growth, which means restating for some products like Evac, last year we were growing in H1 at about 27%.

Speaker #2: To reach $10 billion by 2030, we need to achieve an average CAGR of 15%, given that we're currently growing at a trend of 27%.

Speaker #2: I'm not worried at all about our capacity to reach the $10 billion. And we are just talking about, by the way, the market—most all of these products are already in the market.

François-Xavier Roger: 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 asked 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, but they're already profitable and attractive from a profitability point of view as well.

Speaker #2: So, it's essentially a commercial risk, so I'm not worried about it. You asked a question on the profitability of this business. It is already positive in terms of BOI, which is quite remarkable.

Speaker #2: Due to the fact that we are really in an investment position behind these products to support the growth, but they're already profitable and attractive from a profitability point of view as well.

Speaker #1: The next question will be from Graham Parry from Citi. Graham?

Marie Lang: The next question will be from Graham Parry from Citi. Graham?

Speaker #5: Great, thanks for taking my questions. So just going 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?

Graham Parry: Great. Thanks. A few 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? Then 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 with a new plan that sounds suspiciously like the old plan.

Speaker #5: And in particular, if you were to go with the loan, 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?

Speaker #5: 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 seen in my coverage come in with a new plan that sounds suspiciously like the old plan.

Speaker #5: 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?

Graham Parry: 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.

Speaker #5: Thank you.

Speaker #3: So let me reply very briefly to a question number one. So yes, when we go for BD, eventually M&A is we and of course our internal respective internal pipelines we consider whether the asset can be better performing within the alliance.

Belén Garijo: 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 anything there?

Speaker #3: Manuela, do you want to add a bit more?

Speaker #1: No, I would just add, Graham, that as Belen said earlier, immunology is a large space. And even in dermatology and respiratory, we're looking at opportunities within the alliance.

Manuela Buxo: No. I would just add, Graham, that as Belén said earlier, immunology is a large space. Even dermatology and respiratory, we're 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.

Speaker #1: 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 launch these products, as we are already doing successfully in that context.

Speaker #1: So both are options that we are currently actively reviewing as part of the strategic review that's ongoing.

Speaker #3: So Graham, I'm not exactly sure what you mean when you say that the pipeline plan sounds old. I mean, I assume you mean that the R&D productivity issues at Sanofi have been going on for quite a while, right?

Belén Garijo: 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. 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.

Speaker #3: And we totally frank, we are looking at this as if this 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.

Speaker #3: And I have repeatedly mentioned what the focus areas are in which we are going to emphasize frequently. As you know, turning around R&D productivity takes a bit of time.

Speaker #3: 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 assignments even before.

Speaker #3: I don't think there is a systemically wrong issue in the organization. I think you have to pull the levers, be consistent, and never complacent.

Speaker #3: And 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.

Belén Garijo: 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 best in class, but rather differentiated innovation that can help us move forward.

Speaker #3: Not always aiming for first-in-class and best-in-class, but rather differentiated innovation that can help us move forward.

Speaker #1: The next question is from Simon Baker from Redburn. Simon.

Marie Lang: The next question is from Simon Baker from Redburn. Simon?

Speaker #5: Thank you for taking my question. And welcome back, Belen. It really follows on from Graham's question. And you alluded to it in your response.

Simon Baker: 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 4 to 5 years. What sort of timeframe would you put on this? I am assuming that Paulo's arrival is not a year zero event. There was a lot of restructuring under Houman. Where are we in that transformation journey? 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 31 March out to 2045, I think.

Speaker #5: You're targeting a fast-track R&D transformation. As you said, transforming R&D is not particularly quick. The fastest example I can think of in my time is probably AstraZeneca, which took four to five years.

Speaker #5: So what sort of timeframe would you put on this? I'm assuming that Paolo's arrival is not a year under Houman. So where are we in that transformation journey?

Simon Baker: What sort of timeframe would you put on this? I am assuming that Paulo's arrival is not a year zero event. There was a lot of restructuring under Houman. Where are we in that transformation journey? 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 31 March out to 2045, I think.

Speaker #5: And then a second quick question. All of this, of course, is focused around the loss of exclusivity of Dupixent. And one of the simplest ways of dealing with that is to move the LOE out.

Speaker #5: 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 is 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.

Simon Baker: I'd be interested 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.

Speaker #5: Thanks so much.

Speaker #3: 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.

Belén Garijo: 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 operations 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 will 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.

Speaker #3: And that some of the setbacks, if not a significant number of setbacks, are operational risk. Fixing operations is a bit faster than recruiting expert capabilities to the organization.

Speaker #3: So, as Mike mentioned, our research efforts are already paying back. I'm not saying that this is going to be fast, right? But starting by managing the operational risk actually would be a very good start.

Speaker #3: 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 study design to conclusion of the trial.

Speaker #3: And 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.

Belén Garijo: 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.

Speaker #3: On the LOE of Dupi, I want to hand it over to Roy.

Speaker #5: 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.

Roy Papatheodorou: Thanks, Simon. First of all, you mentioned patents going to 2045. Actually, this quarter, we can say its patent expiration date is 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 is 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 will be able to give you more details of what is being challenged and keep you up to speed, of course.

Speaker #5: 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.

Speaker #5: 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 not expect we do expect Dupixent to be protected beyond March 2031.

Speaker #5: 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.

Speaker #5: Or what is being challenged and keep to you up to speed, of course. But rest assured that we have done our best to make sure that the years of innovation have been protected and we intend to really fight it out.

Roy Papatheodorou: 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.

Speaker #3: What I can tell you, Simon, is that we are taking a base case that is associated with the patent to the loss of the product patent.

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

Marie Lang: The next question is from David Risinger from Leerink. David?

Speaker #1: The next question is from David Riesinger from Leerink. David.

Speaker #2: Yes. Thanks very much. And congratulations, Belen, 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?

David Risinger: Yes, thank you very much. 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 are simply focused on improving judgment and empowering better decision-making from the ground up. Is that the right way to interpret your comments today?

Speaker #2: 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.

Speaker #2: From the ground up, is that the right way to interpret your comments today?

Belén Garijo: 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, over-promised and under-delivered. That is the bottom line, and this basically hit our credibility tremendously. Despite the results of today, for me as a newcomer, it is 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?

Speaker #3: Thank you, David. First of all, I believe that during my conversations with investors, what I learned is that perhaps, for a period of time, we have over-promised and under-delivered.

Speaker #3: 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.

Speaker #3: And that is the only reason that I can find and that I have been able to dilucidate during my conversations with investors. Any other comments in this respect?

Speaker #5: Maybe let me add something: if you look at valuation in our industry, it's essentially driven by two drivers. One of them is growth; Belen just said it.

François-Xavier Roger: Maybe let me add something. I think that if you look at valuation in our industry, it is 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 levels of growth in our industry. The other one is pipeline, on which we know. We made some disclosure lately on our pipelines. 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 you will see certainly in the coming months.

Speaker #5: 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.

Speaker #5: On which, I mean, we know and we met some disclosure lately on our pipeline. So we are aware of the challenges there as well.

Speaker #5: 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.

Speaker #5: 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.

Speaker #1: Yeah.

Belén Garijo: 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.

Speaker #3: 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 Verdoult on the transition between phase two and phase three.

Speaker #3: 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.

Speaker #1: The next question will be from Siemens-Fernandez from Guggenheim. Siemens.

Marie Lang: The next question will be from Seamus Fernandez from Guggenheim. Seamus?

Speaker #5: Oh, thanks very much for the questions. And congrats, Belen, on the coming—two questions from my side. You mentioned two areas that haven't quite been a major focus of the prior sort of management.

Seamus Fernandez: 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 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.

Speaker #5: 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?

Seamus Fernandez: 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.

Speaker #5: 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.

Speaker #5: 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?

Seamus Fernandez: 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. 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.

Speaker #5: 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.

Speaker #5: Or are you talking about the market itself, and the opportunity to reinvest in the market to drive growth? Thanks.

Speaker #3: Thank you. So I hear echo. Do you hear me? Yes. Do you hear me? It's okay. So rare. Yes. In rare, I believe we have an opportunity.

Belén Garijo: Thank you. Very good question. I hear echo. Do you hear me? Yes. Do 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 volume position, because we have a top two or three position in the rare disease market, and I believe this presents an opportunity, and it is giving us and giving our business significant resilience. I think on China, it's 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.

Speaker #3: 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.

Speaker #3: And I believe this presents an opportunity and is giving us—and giving our business—significant resilience. I think, on China, it's both. The market is attractive simply because the population is extremely big.

Speaker #3: So 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?

Speaker #3: So, that is one element of it. And obviously, tapping into and 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.

Belén Garijo: 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.

Speaker #1: The next question is from Michael Lushten from Jefferies. Michael.

Marie Lang: The next question is from Michael Leuchten from Jefferies. Michael?

Speaker #6: Michael.

Speaker #2: Oh, thank you very much. Two questions, please, around the XCOM changes, Belen. One, obviously, you're kind of an outsider with prior experience, and you've brought in Paolo as an outsider.

Michael Leuchten: 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 flexibility? Just talk about the sort of options you have now that previously were not open to you.

Speaker #2: But the rest of the XCOM change is really internal candidates. Can you talk about so the pluses and minuses of not having more new blood in that XCOM to really affect the change?

Speaker #2: You made a very strong point about this being a big job and requiring really drastic changes. And then a similar question, not similar, but related question to Francois on your role now also including BD.

Speaker #2: What changes does that make for you? Does that just increase the speed of action you can perform at? Does it increase flexibility? Just talk about the sort of options you have now that previously were not open to you.

Speaker #3: Michael, thank you for your question. So on the COMEC changes, look, I go externally when I believe there is necessary to search for a more transformative position, right?

Belén Garijo: Michael, thank you for your question. On the ExCom changes, look, I go externally when I believe that it is necessary to search for a more transformative position, right? This is what we have done in R&D. However, when you look at the ExCom, 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. 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. Over the years, I have learned that you always take less risk when you source from internal talent than going outside.

Speaker #3: And this is what we have done in R&D. However, when you look at the COMECs, there are three new members. Two the three of them from our internal talent pipeline.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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 go when you source from internal talent than going outside.

Speaker #3: 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 COMECs.

Belén Garijo: 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 ExCom. There is a significant percentage of the ExCom. Now we are eight. Three are new ExCom members. There is a significant percentage with new eyes. And with this, I hand it over. Of new blood, as you call it.

Speaker #3: I mean, there is a significant percentage of the COMECs. So now we are eight. Three are new COMECs members. So it's a significant percentage with new eyes.

Speaker #3: And with this, I hand it over to new blood, as you call it.

Speaker #2: Okay. So on Michael, on BD, first and foremost, I'm aware of the responsibility that comes with it. I think on second, we have been very successful in BD and in M&A.

François-Xavier Roger: On Michael, on BD, first and foremost, I am aware of the responsibility that comes with it. I think, and 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 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. But we have created quite a substantial value historically with the remaining EUR 40 billion, and I am sure we will have the occasion to discuss a little bit more in details what I am just sharing with you. We have a good track record both in BD and in M&A.

Speaker #2: But just to give you some perspective, globally between BD and M&A, we invested 47 billion euros over the last eight years. And we have lost 7 billion.

Speaker #2: Sorry for the $7 billion. But if we had not lost anything, we would probably not have taken the right level of risk. But we have created quite a substantial value historically with the remaining $40 billion.

Speaker #2: And I'm sure we'll have the occasion to discuss in a little more detail what I've just shared with you. So, we have a good track record both in BD and in M&A.

Speaker #2: I'm honored as well to take over this responsibility, because we know that, as we discussed earlier, BD and M&A are part of the challenge that we have in order to address some of the weaknesses within the organization.

François-Xavier Roger: I am 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. But 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.

Speaker #2: So it will allow 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, it's that BD is not necessarily a naturally within finance in many organizations in pharma.

Speaker #2: 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 has to it will work only if we are super, super close to the R&D organization.

Speaker #1: The next question is from Richard Vosser from JP Morgan. Richard.

Marie Lang: The next question is from Richard Vosser from J.P. Morgan. Richard?

Marie Lang: The next question is from Richard Vosser from JPMorgan. Richard?

Speaker #6: Hi, thanks for taking my questions. Just a couple, please. So, Belen, you've cut a few pipeline programs. Should we think that the review is now complete?

Richard Vosser: 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 enrolled will be responsive to the drug? Thanks very much.

Speaker #6: Or should we think about further discontinuations when Paolo joins? And on that remaining pipeline, there are a couple of phase three assets. That read out in the coming 12 months for XLML and PREBU part.

Speaker #6: Apologies for the pronunciation. Never going to get it. There's some discussion around the chances of success on both. So on Fraxalamab, there's been discussion on the primary endpoint in phase three and the ability to beat Abagio.

Richard Vosser: 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 enrolled will be responsive to the drug? Thanks very much.

Speaker #6: So, just introducing your thoughts and Michael's thoughts there. And then, on the RIPREBU part, the Mobilize trial failed, obviously. What are the learnings from that for the Vitalize trial?

Speaker #6: Are you comfortable that the patient population enrolled will be responsive to the drug? Thanks very much.

Speaker #3: 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?

Belén Garijo: 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.

Speaker #3: We are going to we are going to continue to be operating on the basis of scientific merit and risk, as I mentioned. And potential.

Speaker #3: 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.

Speaker #3: We will be concentrating our resources in those with highest scientific merit. Highest and medical need. And highest potential. On PREXA, do you want to comment, Mike?

Marie Lang: Highest unmet medical need and highest potential. On Frexa, do you want to comment, Mike?

Speaker #2: That's you, Belen. Thank you for the question, Richard. On PREXA in the context of phase three, we're on track to read out RMS in 2027 and SPMS in 2028.

Mike Quigley: Thank you, Belén. Thank you for the question, Richard. On frexalimab, in the context of 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 of focus. The primary doesn't change in the context of annual relapse rates, but we're focused also on key secondary endpoints, including a 6-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.

Speaker #2: 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.

Speaker #2: 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 Fraxalamab readouts that you'll see.

Speaker #2: With respect to Mobilized versus Vitalized, 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 Mobilized study because we were unlikely to meet the primary endpoint.

Mike Quigley: 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 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.

Speaker #2: But I can say is that the two patient populations between the two studies are very different. So we have a refactory patient population in the mobilized study.

Speaker #2: 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 are still progressing despite that treatment paradigm.

Speaker #2: And so that comparison versus IGIG and that patient population is where we're looking at it. Vitalized. Importantly, what I can also add is that the IDMC looked also at vitalized and recommended progressing vitalized forward.

Speaker #2: And so we have hope and we're on track to continue to read that out in the latter half of 2027.

Mike Quigley: We have hope, and we're on track to continue to read that out in the H2 of 2027.

Speaker #1: The next question is from Matthew Weston from UBS. Matt.

Marie Lang: The next question is from Matthew Weston from UBS. Matt?

Speaker #6: Thank you very much. Belen, a warm welcome back. My first question is for Manuela, and it comes back to Pete's question on Dupixent gross to net.

Matthew Weston: 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? I ask that because that's the only thing I can think of that's the really significant improvement in GTN over the H1 of the year. 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? 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.

Speaker #6: Can I push you on your operational effectiveness comment? Has the alliance changed its policy on 340(b) claims for dupi to reduce access to heavily discounted drug?

Speaker #6: And I ask that because that's the only thing I can think of that's really improvement in GTN over the first half of the year.

Speaker #6: And then I guess, if that is the case, why won't that trend continue? And why shouldn't dupi be able to deliver stronger than is suggested by the 10% total revenue guide that we've increased to?

Speaker #6: 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.

Speaker #6: I know that some of that is FX. But is it because you're meaningfully more cautious on Bayfortus? Or is it the flu franchise? Or is it something else?

Matthew Weston: 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?

Speaker #3: Yeah. So thank you, Matt, for that question. So when we talk about operational improvement or operational effectiveness, fully agree that it is linked to 340(b) partially.

Manuela Buxo: Thank you, Matt, for that question. When we talk about operational improvements or 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 H2.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 340(b), enhanced 340(b) control is a part of that. It's not the only part, but it's a part of that—a large part of it.

Speaker #3: 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.

Manuela Buxo: The reason why we're talking about a more moderate growth in the H2 versus the H1 is simply the H2 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 H1 of this year.

Speaker #3: 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.

Speaker #1: Maxim.

Marie Lang: Matthew?

Speaker #2: 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 place in 2023, if I recall correctly.

Thomas Triomphe: Regarding the second question, hello, Matthew. Thomas speaking. Thanks for the questions. For the 2030 vaccines ambition, you have 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 EUR 1 billion difference for 2030 is coming on one half of it from a US exchange rate, so US to euro, it is pure financial exchange rate. The second half is driven mostly by US VCR. US VCR evolution, which has turned out to be weaker than expected following the new US administration. Indeed, it is mostly into the respiratory area, so classical flu and RSV.

Speaker #2: So, way before the change of administration. When we look at the drivers of this, this $1 billion difference for 2030 is coming, on one half of it, from a U.S. exchange rate.

Speaker #2: So US to euro, it's pure financial exchange rate. The second half is driven mostly by US VCR. So US VCR evolution, which has turned out to be weaker than expected following the new US administration.

Speaker #2: And indeed, it's mostly in the respiratory area—so classical flu and RSV. But also, you've seen that the CDC and other avenues have shown that there has been a decrease in the vaccination coverage rate of US pediatric vaccines.

Thomas Triomphe: Also you have seen that CDC and other avenues have shown that there has been a decrease on the vaccination coverage rate of US pediatric vaccines also. If you put both together, that explains the difference. Does not 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 US overall, I would say, policy.

Speaker #2: 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.

Speaker #2: But indeed, we wanted to recalibrate what has changed with the latest both exchange rate and US overall, I would say, policy.

Speaker #1: The next question is from Florence Espedez, from Odo.

Marie Lang: The next question is from François-Xavier Perez from ODDO. François?

Speaker #5: Good afternoon. Florence Espedez from Odo VHF. Thank you very much for taking my questions. Two quick ones, please. First, for Belen, you have announced that you have discontinued some of the projects and some products in the pipeline.

[Analyst] (ODDO BHF): Good afternoon. François-Xavier 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, but do you have some projects remaining in the pipeline where you have strong confidence? My first question. My second question for Thomas

Florent Cespedes: Good afternoon. François-Xavier 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, but do you have some projects remaining in the pipeline where you have strong confidence? My first question. My second question for Thomas

Speaker #5: 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.

Speaker #5: 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?

[Analyst] (ODDO BHF): On China, 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.

Florent Cespedes: On China, 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.

Speaker #5: Thank you.

Speaker #3: Hi, Florence. So, listen, of course, as we prioritize our assets—confronting stage of development versus potential, understanding of the biology versus base of development, et cetera, et cetera.

Belén Garijo: 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, also has spoken a bit of the outlook towards next year. I will remain very prudent until I see more data. Obviously, once we have those solid data that we need to see, we will come back to you to tell you. As I mentioned during my introductory remarks, we are aiming to give you some kind of perspective in the coming quarters.

Speaker #3: 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.

Speaker #3: I think 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.

Speaker #3: 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 more broader perspective on where are we on the strategy and the pipeline.

Belén Garijo: Obviously, before the year end, we are expecting to give you a broader perspective on where are we on the strategy and the pipeline. On China, the question is for Thomas.

Speaker #3: On China, the question was for Thomas.

Speaker #2: PTC, a few words. Thanks, Florence. Don't expect today 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.

Thomas Triomphe: 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 1 September. 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've 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, so excited by both aspects.

Speaker #2: As previously mentioned by Belen, 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, really interesting.

Speaker #2: We want to double down on our efforts there. We started some, and we want to accelerate on this. But indeed, alternatively, if you look also at the China local pharmaceutical marketplace, it's also a very interesting marketplace.

Speaker #2: First and foremost, because it's a very competitive one. And 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.

Speaker #2: So excited by both aspects. What I want to highlight, of course, is that this can only be done in extremely close collaboration first with R&D.

Thomas Triomphe: 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 is going to be a transversal effort with all the outcome to be able in China to be as competitive as we can.

Speaker #2: When it comes to innovation, so extremely looking forward to work further with Paulo and Mike on this journey. And of course, for the competitiveness of the overall market, it's going to be a transversal effort with all the XCOM to be able in China to be as competitive as we can.

Speaker #1: The last question will be from James Gordon from Barclays. James.

Belén Garijo: The last question will be from James Gordon from Barclays. James?

Speaker #6: 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 areas?

James Gordon: 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 will 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?

Speaker #6: 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?

Speaker #6: 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?

Speaker #6: 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?

Speaker #6: The second question was just about spend. So we've heard that you 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?

James Gordon: 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?

Speaker #6: 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?

Speaker #6: Is there an opportunity there? And then just squeezing in a clarification, please. On the general partnership, is it just about communication and trust, or could you are you actually looking at the structure of the partnership at all?

Speaker #6: Does that off the table or is that also under consideration?

Speaker #3: Let me start by the general question. So as I mentioned, it's a combination of looking at options to eventually expand the alliance with assets from both sides, right?

Belén Garijo: 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, to be honest, it's a matter of opportunity. You can count that it will be a combination of a strategic fit.

Speaker #3: 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.

Speaker #3: So this is exactly what I have repeatedly said during the call of today. Regeneron is of a strategic importance to us. And therefore, we will continue the already initiated conversations to be able to land what is best for both companies.

Speaker #3: On M&A. On M&A, to be honest, it's a matter of opportunity but you can count that we will it will be a combination of a strategic fit.

Speaker #3: 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.

Belén Garijo: 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. We may, after combining M&A with BD to support platforms and research, whenever it is 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, any potential option that will create value for our shareholders. Reallocation of the spend to R&D?

Speaker #3: So we may, after combining M&A with BD, BD to support platforms and research, whenever it's more late stage, it will be complementing what we can generate inside.

Speaker #3: 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.

Speaker #3: It can be partnering. It can be offering those businesses to other companies. So any potential option that will create value for our shareholders. Reallocation of spend to R&D.

Speaker #2: Yeah, I can take that one. James, but first, I confirm there is no urgency, dramatic urgency. In terms of BD M&A, we are not driven by any timing objective.

François-Xavier Roger: Yes, 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.

Speaker #2: 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.

Speaker #2: We don't need necessarily to 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.

Speaker #2: So if there is a better return on the commercial side of things, that's what we will do. So we don't necessarily we don't manage fixed budget within a certain category of investments.

François-Xavier Roger: We don't manage fixed budget within a certain category of investments. 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 Medicine, 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, our choices on cost allocation and investment allocation are driven by contribution to growth and returns.

Speaker #2: 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.

Speaker #2: We have decided to reallocate most of it behind growth assets, essentially within spec care and starting with Dupixent. And you saw what it means today.

Speaker #2: You saw it with our impressive almost 18% growth in Q2. So once again, this is driven door choices and cost allocation and investment allocation are driven by contribution to growth and returns.

Speaker #3: Okay, so 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.

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

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