Q3 2025 Ipsen SA Earnings Call

October 22, 2025

Operator: Hello and welcome to Ipsen's Conference Call and Webcast on Q3 2025 results. I'll now hand you over to David Loew, Ipsen's CEO.

Laura Hindley: Hello and welcome to Ipsen's conference call and webcast on Q3 2025 results. I'll now hand you over to David Loew, Ipsen's CEO.

Speaker #2: Hello and welcome to IPSEN s conference call and webcast on Q3 2025 . Results . I'll now hand you over to David Lowe , IPSEN CEO .

David Loew: Thank you. Hello, everyone. I'm delighted to welcome you this afternoon to our year-to-date and Q3 sales presentation, which can also be found on ipsen.com. It's a pleasure to take you through the progress we are making this year. Please turn to slide 2. Please note of our forward-looking statement which outlined the routine risk and uncertainties contained within this presentation. All of my comments on growth will be based on constant exchange rates. Please turn to slide 3. I'm going to take you through our brief presentation. Then our CFO, Aymeric Le Chatelier, and our Head of R&D, Christelle Huguet, will join me to answer your questions. Let's begin by taking a look at today's highlights. Please turn to slide 4. Today's highlights illustrate how we are continuing to deliver strong growth.

David Loew: Thank you and hello everyone. I'm delighted to welcome you this afternoon to our year-to-date and third-quarter sales presentation, which can also be found on ipsen.com. It's a pleasure to take you through the progress we are making this year. Please turn to slide two. Please note our forward-looking statement, which outlines the routine risk and uncertainties contained within this presentation. Also, all of my comments on growth will be based on constant exchange rates. Please turn to slide three. I'm going to take you through our brief presentation, and then our CFO, Aymeric Chatelier, and our Head of R&D, Christelle Huguet, will join me to answer your questions. Let's begin by taking a look at today's highlights. Please turn to slide four. Today's highlights illustrate how we are continuing to deliver strong growth. Total sales grew by 13.7% this quarter and by 12.1% in the first nine months.

Speaker #3: Thank you . And hello , everyone . I'm delighted to welcome you . This afternoon to our year to date and third quarter sales presentation , which can also be found on IPSEN .

Speaker #3: Com . It's a pleasure to take you through the progress we are making this year . Please turn to slide two . Please note of our forward looking statement which outlined the routine risk and uncertainties contained within this presentation .

Speaker #3: Also , all of my comments on growth will be based on constant exchange rates . Please turn to slide three . I'm going to take you through our brief presentation and then our CFO , Aymeric Chatelier and our head of R&D , Christelle Huguet will join me to answer your questions .

Speaker #3: Let's begin by taking a look at today's highlights. Please turn to slide four. Today's highlights illustrate how we are continuing to deliver strong growth.

David Loew: Total sales grew by 13.7% this quarter and by 12.1% in the first 9 months. We are very pleased to see a strong performance of our portfolio outside somatostatin, which grew by 12.3% in the 9-month period. Based on this continued solid momentum and strong growth, we are pleased to further upgrade our full year 2025 guidance. We now expect total sales growth around 10% at constant exchange rates as compared to our last guidance from July of sales growth above 7%. Regarding margin, we now expect the core operating margin around 35% of total sales as compared to more than 32% in our last guidance. Turning to the pipeline, we are delighted by the first data for our first-in-class differentiated long-acting molecule IPN10200, enabling the initiation of phase III trial in aesthetics.

Speaker #3: Total sales grew by 13.7% this quarter and by 12.1% in the first nine months. We are very pleased to see a strong performance of our portfolio outside Somatuline, which grew by 12.3% in the nine-month period.

David Loew: We are very pleased to see a strong performance of our portfolio outside Somatuline, which grew by 12.3% in the nine-month period. Based on this continued solid momentum and strong growth, we're pleased to further upgrade our full-year 2025 guidance. We now expect total sales growth around 10% at constant exchange rates as compared to our last guidance from July of sales growth above 7%. Regarding margin, we now expect the core operating margin around 35% of total sales as compared to more than 32% in our last guidance. Turning to the pipeline, we are delighted by the first data for our first-in-class differentiated long-acting molecule IPN10-200, enabling the initiation of phase 3 trial in aesthetics. In rare disease, we were pleased to receive the approval of Bylvay in Japan for PFIC, offering a non-surgical treatment option for infants, young children, and adults.

Speaker #3: Based on this continued solid momentum and strong growth , we are pleased to further upgrade our full year 2025 guidance . We now expect total sales growth around 10% at constant exchange rates as compared to our last guidance from July of sales growth above seven .

Speaker #3: Regarding margin, we now expect a core operating margin of around 35% of total sales, compared to more than 32% in our last guidance.

Speaker #3: Turning to the pipeline , we are delighted by the first data for our first in class differentiated , long acting molecule Ip10 200 , enabling the initiation of phase three trial in anaesthetics in rare disease , we were pleased to receive the approval of Bylvay in Japan for pfic offering a non-surgical treatment option for infants , young children and adults .

David Loew: In rare disease, we were pleased to receive the approval of Bylvay in Japan for PFIC, offering a non-surgical treatment option for infants, young children, and adults. In July, we announced the European approval of Cabometyx in NETs, an area where Ipsen has a strong legacy. We're also excited to announce the addition of ICT01 into Ipsen's clinical oncology pipeline following the intention to acquire ImCheck Therapeutics. Let me provide you more details on this deal. Turn to slide 5. This deal is focused on the lead clinical-stage program ICT01 in first-line unfit patients with acute myeloid leukemia, including high-risk patients who are ineligible for intensive chemotherapy. Another strong addition to our pipeline as we expand our leadership in oncology.

David Loew: Also in July, we announced the European approval of Cabometyx in NETs, an area where Ipsen has a strong legacy. We're also excited to announce the addition of ICT01 into Ipsen's clinical oncology pipeline, following the intention to acquire Imcheck Therapeutics. Let me provide you more details on this deal. Turn to slide five. This deal is focused on the lead clinical stage program ICT01 in first-line unfit patients with acute myeloid leukemia, including high-risk patients who are ineligible for intensive chemotherapy. Another strong addition to our pipeline as we expand our leadership in oncology. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune regulatory molecule broadly expressed across cancer, and follows strong data presented by the Imcheck team at ASCO 2025. ICT01 is currently in phase 2 trials for acute myeloid leukemia, and we hope to be able to start the phase 2B/3 trial in 2026.

Speaker #3: Also in July, we announced the European approval of Cabometyx in PNETs, an area where Ipsen has a strong legacy. We're also excited to announce the addition of Icht Zero One into Ipsen's clinical oncology pipeline.

Speaker #3: Following the intention to acquire Imject Therapeutics . So let me provide you more details on this deal . Turn to slide five . This deal is focused on the lead clinical stage program Ikt zero one .

Speaker #3: In first line unfit patients with acute myeloid leukemia , including high risk patients who are ineligible for intensive chemotherapy . Another strong addition to our pipeline , as we expand our leadership in oncology .

David Loew: ICT01 is a first in class monoclonal antibody targeting BTN3A, a key immune regulatory molecule broadly expressed across cancer and follows strong data presented by the ImCheck team at ASCO 2025. ICT01 is currently in Phase II trials for AML. We hope to be able to start the Phase IIb/III trial in 2026. Ipsen proposed to acquire all issued and outstanding shares of ImCheck Therapeutics for a closing purchase price of EUR 350 million and downstream payments contingent upon achievement of regulatory and sales-based milestones, with an expected closing by the end of the year or early 2026. Turn to slide 6.

Speaker #3: It's zero one is a first in class monoclonal antibody targeting btn3a1 , a key immune regulatory molecule broadly expressed across cancer . And follows strong data presented by the team at Asco 2025 .

Speaker #3: ICT oh one is currently in phase two trials for AML , and we hope to be able to start the phase two B three trial in 2026 .

David Loew: Ipsen proposed to acquire all issued and outstanding shares of Imcheck Therapeutics for a closing purchase price of €350 million and downstream payments contingent upon achievement of regulatory and sales-based milestones, with an expected closing by the end of the year or early 2026. Turn to slide six. Our Q3 sales delivered a solid 13.7% growth and 12.1% in the year-to-date viewed by all three therapeutic areas, with an improvement of performance for neuroscience and rare disease this quarter compared to last quarter. The portfolio outside of Somatuline is growing at 16.7% in the quarter and 12.3% year-to-date. Oncology performed well with sales growth of 7% this quarter and 6.6% year-to-date. Rare disease continued to have the most impressive performance of our portfolio, with sales doubling both this quarter and in year-to-date. Neuroscience with Dysport continued to deliver high single-digit growth. I'll now turn to oncology for more details.

Speaker #3: IPSEN proposed to acquire all issued and outstanding shares of Imject Therapeutics for a closing purchase price of €350 million, along with downstream payments contingent upon the achievement of regulatory and sales-based milestones.

Speaker #3: With an expected closing by the end of the year or early 2026 . Turn to slide six . Our Q3 month sales delivered a solid 13.7% growth and 12.1% in the year to date , fueled by all three therapeutic areas with an improvement of performance for neuroscience and rare disease .

David Loew: Our Q3 month sales delivered a solid 13.7% growth and 12.1% in the year-to-date, fueled by all 3 therapeutic areas with an improvement of performance for neuroscience and rare disease this quarter compared to last quarter. The portfolio outside of somatostatin is growing at 16.7% in the quarter and 12.3% year-to-date. Oncology performed well with sales growth of 7% this quarter and 6.6% in year-to-date. Rare disease continued to have the most impressive performance of our portfolio, with sales doubling both this quarter and in year-to-date. Neuroscience with Dysport continued to deliver high single-digit growth. I'll now turn to oncology for more details. Please turn to slide 7. Starting with somatostatin, sales were up by 11.7% year-to-date.

Speaker #3: This quarter, compared to last quarter, the portfolio outside of Somatuline is growing at 16.7% in the quarter and 12.3% year-to-date.

Speaker #3: Oncology performed well , with sales growth of 7% this quarter and 6.6 in year to date . Rare disease continue to have the most impressive performance of our portfolio , with sales doubling both this quarter and in year to date .

Speaker #3: Neuroscience with Dysport continued to deliver high single-digit growth. I'll now turn to oncology for more details. Please turn to slide seven.

David Loew: Please turn to slide seven. Starting with Somatuline, sales were up by 11.7% year-to-date. Both Europe and the U.S. continue to benefit from shortages of generic lanreotide. While we do anticipate lanreotide generic competition with potential new entry next year, it is apparent that it is a complicated product to manufacture. Cabometyx sales were up by 2.9%, with solid performance in Europe from increased volumes offset by shipment phasing and increased competition in the rest of the world. Q3 performance was at 9.3%, including the rest of the world returning to growth. NET's launch in Europe is progressing well, with the first patients treated in Germany and additional reimbursements to come soon. Decapeptyl sales were up by 2.2% as we experienced volume growth in Europe and China, despite continued competition and some pricing pressure in some countries.

Speaker #3: Starting with Somatuline, sales were up by 11.7% year to date. Both Europe and the U.S. continue to benefit from shortages of generic lanreotide.

David Loew: Both Europe and the US continued to benefit from shortages of generic lanreotide. While we do anticipate lanreotide generic competition with potential a new entry next year, it is apparent that it is a complicated product to manufacture. Cabometyx sales were up by 2.9%, with solid performance in Europe from increased volumes offset by shipment phasing and increased competition in the rest of world. Q3 performance was at 9.3%, including the rest of world returning to growth. NETs launch in Europe is progressing well, with the first patients treated in Germany and additional reimbursements to come soon. Pegaptanib sales were up by 2.2% as we experienced volume growth in Europe and China despite continued competition and some pricing pressure in some countries.

Speaker #3: While we do anticipate Lanreotide generic competition with potential new entry next year, it is apparent that it is a complicated product to manufacture.

Speaker #3: Cosmetic sales were up by 2.9%, with solid performance in Europe from increased volumes, offset by shipment phasing and increased competition in the rest of the world. Q3 performance was at 9.3%, including the rest of the world returning to growth.

Speaker #3: Nets' launch in Europe is progressing well, with the first patients treated in Germany and additional reimbursements to come soon. Decapeptyl sales were up by 2.2% as we experienced volume growth in Europe and China.

Speaker #3: Despite continued competition and some pricing pressure in some countries, Onivyde sales grew by 4.8%, with moderate growth in the U.S. driven by the first-line metastatic pancreatic ductal adenocarcinoma indication.

David Loew: Onivyde sales grew by 4.8%, with moderate growth in the U.S., driven by the first-line metastatic pancreatic ductal adenocarcinoma indication. We continue to expect challenges in the U.S., as communicated previously. Now let's turn to rare disease. Please turn to slide eight. In rare disease, Bylvay continues to perform well, with year-to-date sales of €135 million growing by 46%, driven by strong demand in the U.S. and in Europe in both PFIC and Alagille syndrome indications, despite increased competition. We're pleased to soon also launch in Japan, where so far we didn't have an Ipsen commercial presence and where Bylvay will be the first of several drugs to be launched by our new affiliates, opening up this important market. Turning to Iqirvo, we continue to track very well, with sales reaching €107 million this year.

David Loew: Onivyde sales grew by 4.8%, with moderate growth in the US driven by the first-line metastatic pancreatic ductal adenocarcinoma indication. We continue to expect challenges in the US as communicated previously. Now let's turn to rare disease. Please turn to slide eight. In rare disease, Bylvay continues to perform well with year-to-date sales of EUR 135 million growing by 46%, driven by strong demand in the US and in Europe in both PFIC and Alagille syndrome indications despite increased competition. We're pleased to soon also launch in Japan, where so far we didn't have an Ipsen commercial presence and where Bylvay will be the first of several drugs to be launched by our new affiliate, opening up this important market. Turning to IQIRVO, we continue to track very well with sales reaching EUR 107 million this year.

Speaker #3: We continue to expect challenges in the U.S., as communicated previously. Now let's turn to rare disease. Please turn to slide eight.

Speaker #3: In rare disease , Bylvay continues to perform well with year to date sales of €135 million growing by 46% , driven by strong demand in the US and in Europe .

Speaker #3: In both fake and Alagille syndrome . Indications . Despite increased competition , we're pleased to soon also launch in Japan , where so far we didn't have an IPSEN commercial presence and where Bylvay will be the first of several drugs to be launched by our new affiliate .

Speaker #3: Opening up this important market . Turning to Iqirvo , we continue to track very well with sales reaching €107 million this year . In Q3 , we saw strong growth in the US with a 46% growth quarter over quarter , driven by an increasing update from new patients .

David Loew: In Q3, we saw strong growth in the U.S., with a 46% growth quarter over quarter, driven by an increasing uptake from new patients. We also note the recent withdrawal of Ocaliva for PBC from the U.S., and we expect to see many of these patients transition to Iqirvo towards the end of this year and into 2026. The Europe launch gains momentum with more countries coming online, with reimbursements achieved now in several countries. Moving to neuroscience, let's turn to slide nine. Dysport is performing well in aesthetics, where sales are up by 12.3%. We have seen continued growth in most territories, augmented by share gains in some countries. European markets have remained robust, with a good performance despite negative phasing of shipments to our partner. In therapeutics, Dysport sales grew by 5.2%, both in Europe and in the U.S.

David Loew: In Q3, we saw strong growth in the US with a 46% growth quarter-over-quarter, driven by an increasing update from new patients. We also note the recent withdrawal of OCALIVA for PBC from the US. We expect to see many of these patients transition to IQIRVO towards the end of this year and into 2026. The Europe launch gains momentum with more countries coming online, with reimbursements achieved now in several countries. Moving to neuroscience, let's turn to slide 9. Dysport is performing well in aesthetics, where sales are up by 12.3%. We have seen continued growth in most territories, augmented by share gains in some countries. European markets have remained robust with a good performance despite negative phasing of shipments to our partner. In therapeutics, Dysport sales grew by 5.2% both in Europe and in the US.

Speaker #3: We also note the recent withdrawal of Ocaliva for PBC from the US, and we expect to see many of these patients transition to Acbo towards the end of this year and into 2026.

Speaker #3: The Europe launch gains momentum, with more countries coming online and reimbursements achieved now in several countries moving to neuroscience. Let's turn to slide nine.

Speaker #3: Dysport is performing well in aesthetics, where sales are up by 12.3%. We have seen continued growth in most territories, augmented by share gains in some countries.

Speaker #3: European markets have remained robust, with good performance despite the negative phasing of shipments to our partner in therapeutics. Dysport sales grew by 5.2%, both in Europe and in the U.S.

David Loew: Rest of the world performance was impacted by phasing of inventories in Brazil in the first half, but delivered solid growth in Q3. We are very pleased with how well Dysport has performed overall this year, and we are committed to high single digits growing forward. That concludes the review of sales. Now let's turn to the pipeline. Please turn to slide 10. We have a well-balanced pipeline across the three therapeutic areas. The deal announced today will further strengthen our hematology pipeline. I would like to spend some time now focusing on the update for our long-acting program. Please turn to slide 11. In September, we announced the proof of concept data for IPN10200, Ipsen's uniquely engineered recombinant first-in-class molecule. These first data in global alliance follow the completion of stage one of the ongoing phase II LANTIC trial.

David Loew: The rest of the world performance was impacted by phasing of inventories in Brazil in the first half, but delivered solid growth in the third quarter. We're very pleased with how well Dysport has performed overall this year, and we are committed to high single-digit growth going forward. That concludes the review of sales. Now let's turn to the pipeline. Please turn to slide 10. We have a well-balanced pipeline across the three therapeutic areas. The deal announced today will further strengthen our hematology pipeline. I would like to spend some time now focusing on the updates for our long-acting program. Please turn to slide 11. In September, we announced the proof of concept data for IPN10-200, Ipsen's uniquely engineered recombinant first-in-class molecule. These first data in GLOBAL Alliance follow the completion of stage one of the ongoing phase 2 LANTIC trial.

Speaker #3: Rest of the world performance was impacted by the phasing of inventories in Brazil in the first half, but delivered solid growth in the third quarter.

Speaker #3: We are very pleased with how well this board has performed overall this year, and we are committed to high single-digit growth moving forward.

Speaker #3: That concludes the review of sales. Now let's turn to the pipeline. Please turn to slide ten. We have a well-balanced pipeline across the three therapeutic areas.

Speaker #3: The deal announced today will further strengthen our hematology pipeline. I would like to spend some time now focusing on the update for our long-acting program.

Speaker #3: Please turn to slide 11 . In September , we announced the proof of concept data for IPN ten 200 IPSEN . Uniquely engineered recombinant first in class molecule .

Speaker #3: These first data on glabellar lines follow the completion of stage one of the ongoing Phase 2 Lantic trial. We announced that patients treated with IPM-10 200 experienced a statistically significant improvement in response at week four versus placebo.

David Loew: We announced that patients treated with IPN10-200 experienced a statistically significant improvement in response at week four versus placebo, the primary endpoint. A longer duration of effect was also observed, with a substantial majority of patients experiencing a clinically significant response at week 24, compared with placebo and Dysport, defined as none or mild of line severity at week 24. IPN10-200 was shown to be well tolerated, with no safety concerns reported with any of the evaluated doses of IPN10-200 across stage one. Furthermore, the data demonstrated a rapid onset of action documented by patient diary data and superior patient satisfaction scores versus placebo and Dysport. The full data will be shared at the scientific conference in the first half of 2026, and phase 3 startup activities in aesthetics have been initiated.

David Loew: We announced that patients treated with IPN10200 experienced a statistically significant improvement in response at week 4 versus placebo, the primary endpoint. A longer duration of effect was also observed, with a substantial majority of patients experiencing a clinically significant response at week 24 compared with placebo and Dysport, defined as normal mild offline severity at week 24. IPN10200 was shown to be well tolerated, with no safety concerns reported with any of the evaluated doses of IPN10200 across stage 1. Furthermore, the data demonstrated a rapid onset of action documented by patient diary data and superior patient satisfaction scores versus placebo and Dysport. The full data will be shared at the scientific conference in the first half of 2026, and phase 3 start-up activities in aesthetics have been initiated.

Speaker #3: The primary end point , a longer duration of effect , was also observed with a substantial majority of patients experiencing a clinically significant response at week 24 , compared with placebo and dysport , defined as none or mild off line severity .

Speaker #3: At week 24, IPSEN ten 200 was shown to be well tolerated, with no safety concerns reported with any of the evaluated doses of IPM ten 200 across Stage One.

Speaker #3: Furthermore, the data demonstrated a rapid onset of action, documented by patient diary data, and superior patient satisfaction scores versus placebo and Dysport.

Speaker #3: The full data will be shared at the scientific conference in the first half of 2026, and phase three startup activities in aesthetics have been initiated.

David Loew: The phase 2 LANTIC trial remains ongoing, with stage two currently recruiting patients to evaluate the safety and efficacy of IPN10-200 compared to placebo in frown lines or lateral canthal lines. Phase 2 development continues for therapeutic indications, including adult upper limb spasticity, migraine, and cervical dystonia. Turn to slide 12. We're expecting an update in rare disease, where we should report the pivotal Falcon trial results for Fidrisertib in the coming months. Looking ahead to 2026, it is going to be a busy year for the pipeline, with several anticipated phase 3 data readouts across all three therapeutic areas, including for Bylvay in biliary atresia, IQIRVO in PBC, as well as migraine trial readouts for Dysport. Please turn to slide 13. I would now like to conclude. We continue to deliver strong momentum and remain firmly on track to achieve our ambitions. There are two key messages.

David Loew: The phase II LANTIC trial remains ongoing, with Stage 2 currently recruiting patients to evaluate the safety and efficacy of IPN10200 compared to placebo in forehead lines or lateral canthal lines. Phase II development continues for therapeutic indications including adult upper limb spasticity, migraine, and cervical dystonia. Turn to slide 12. We're expecting an update in rare disease, where we should report the pivotal FALKON trial results for fidrisertib in FOP in the coming months. Looking ahead to 2026, it is going to be a busy year for the pipeline, with several anticipated phase III data readouts across all three therapeutic areas, including for Bylvay in biliary atresia, IQIRVO in PBC, as well as migraine trial readouts for Dysport. Please turn to slide 13. I would now like to conclude. We continue to deliver strong momentum and remain firmly on track to achieve our ambitions.

Speaker #3: The Phase Two trial remains ongoing, with Stage Two currently recruiting patients to evaluate the safety and efficacy of IPM Ten 200 compared to placebo in four horizontal or lateral canthal lines.

Speaker #3: Phase two development continues for therapeutic indications , including adult upper limb spasticity , migraine and cervical dystonia . Turn to slide 12 . We're expecting an update in rare disease where we should report the pivotal Falcon trial results for Vitrasert in FLP in the coming months .

Speaker #3: Looking ahead to 2026, it is going to be a busy year for the pipeline, with several anticipated phase three data readouts across all three therapeutic areas, including for Bylvay in biliary atresia, occurring in PBC as well as migraine.

Speaker #3: Trial readouts for Dysport. Please turn to slide 13. I would now like to conclude that we continue to deliver strong momentum and remain firmly on track to achieve our ambitions.

David Loew: There are two key messages. First, we are delivering strong financials with double-digit growth of our top line, fueled by the performance of our existing portfolio and launches, as well as we upgrade our sales and margin guidance today. This consistent growth reflects our focus on execution and our ability to deliver across both commercial and medical fronts. Second, we continue to expand the pipeline with the proposed acquisition of ImCheck Therapeutics, progression of IPN10200, and multiple catalysts to come over the next 18 months. Finally, we have significant firepower to pursue external innovation. We remain disciplined but ambitious, and we are well positioned to seize the right opportunities to further strengthen our portfolio. We're committed to advancing science with purpose to bring the benefits patients are looking for as we believe everyone deserves a life fully lived. With that, please turn to slide 14.

Speaker #3: There are two key messages . First , we're delivering strong financials with double digit growth of our top line , fueled by the performance of our existing portfolio and launches , as well as we upgrade our sales and margin guidance .

David Loew: First, we're delivering strong financials with double-digit growth of our top line, fueled by the performance of our existing portfolio and launches, as well as we upgrade our sales and margin guidance today. This consistent growth reflects our focus on execution and our ability to deliver across both commercial and medical fronts. Second, we continue to expand the pipeline with the proposed acquisition of Imcheck Therapeutics, progression of IPN10-200, and multiple catalysts to come over the next 18 months. Finally, we have significant firepower to pursue external innovation. We remain disciplined but ambitious, and we are well positioned to seize the right opportunities to further strengthen our portfolio. We're committed to advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived. With that, please turn to slide 14. This concludes our presentation, and we will now take your questions.

Speaker #3: Today, this consistent growth reflects our focus on execution and our ability to deliver across both commercial and medical fronts. Second, we continue to expand the pipeline with the proposed acquisition of Inject Therapeutics.

Speaker #3: Progression of IPM ten 200 and multiple catalysts to come over the next 18 months. Finally, we have significant firepower to pursue external innovation.

Speaker #3: We remain disciplined but ambitious, and we are well positioned to seize the right opportunities to further strengthen our portfolio. We're committed to advancing science with purpose to bring the benefits patients are looking for.

Speaker #3: As we believe everyone deserves a life fully lived . With that , please turn to slide 14 . This concludes our presentation and we will now take your questions .

David Loew: This concludes our presentation, and we will now take your questions. Operator, over to you.

David Loew: Operator, over to you.

Speaker #3: Operator: Over to you.

Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. Please stand by while we compile the Q&A queue. Our first question comes from the line of Charles Pitman-King from Barclays. Please go ahead. Your line is open.

Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A queue. Our first question comes from the line of Charles Pitman King from Barclays. Please go ahead. Your line is open.

Speaker #2: Thank you. To ask a question, you will need to press *1 and 1 on your telephone and wait for your name to be announced.

Speaker #2: To withdraw your question, please press star one, and one again. Please stand by while we compile the Q&A queue. Our first question comes from the line of Charles Pittman King from Barclays.

Speaker #2: Please go ahead. Your line is open.

Charles Pitman-King: Hi, Charles Pitman-King from Barclays. Thank you very much for taking my questions too, please. Maybe just to start off, just wondering if you could give us a few more thoughts on the kind of Dysport phasing at this point. I'm wondering if you're able to kind of quantify the impact here of Q3 versus Q4. Can we expect that, you know, there's going to be some form of catch up there? I'm just wondering if you can provide a little bit more color on the end market dynamics for Dysport across aesthetics and therapeutics versus peers, including specifically just how you're currently viewing Galderma's positioning of Dysport versus Relfidista, given that's where a lot of investors are focused, as of our feedback this morning. Second question, please, on Semaglutide and guidance.

[Analyst]: Hi, Charles Pitman King from Barclays. Thank you very much for taking my questions too, please. Maybe just to start off, just wondering if you could give us a few more thoughts on the kind of Dysport phasing at this point. I'm wondering if you're able to kind of quantify the impact here of Q3 versus Q4. Can we expect that there's going to be some form of catch-up there? I'm just wondering if you can provide a little bit more color on the end market dynamics for Dysport across aesthetics and therapeutics versus peers, including specifically just how you're currently viewing Galderma's positioning of Dysport versus Revance, given that's where a lot of investors are focused as of our feedback this morning. Second question, please, then on Somatuline and guidance. The guidance that you provided today reflects limited impact expected from generic erosion for the rest of the year.

Speaker #4: Hi , Charles King from Barclays . Thank you very much for taking my questions to please . And maybe just to start off , just wondering if you could give us a few more thoughts on the kind of dysport phasing at this point , I'm wondering if you're able to kind of quantify the impact here of three Q versus four Q ?

Speaker #4: Can we expect that there's going to be some form of catch-up there? And wondering if you can provide a little bit more color on the end market dynamics for Dysport across aesthetics and therapeutics versus peers, including specifically just how you're currently viewing Galderma's positioning of Dysport versus RHA, given that where a lot of investors are focused as of our feedback this morning.

Speaker #4: Second question, please. Then on Somatuline and guidance, the guidance that you provided today reflects limited impact expected from generic erosion for the rest of the year.

Charles Pitman-King: The guidance that you provide today reflects limited impact expected from generic erosion for the rest of the year. I'm just wondering how that compares to your assumption behind the guidance at 1H 2025. Given the degree of margin expansion guidance between 1H and Q3, can we assume this is entirely driven by semaglutide not facing as high erosion as you had anticipated? What this could mean for 2026, given your expectation that generics could ramp up over that, over next year, could margins decline year-over-year? Any commentary would be great. Thank you.

[Analyst]: I'm just wondering how that compares to your assumption behind the guidance at H1 2025. Given the degree of margin expansion guidance between H1 and Q3, can we assume this is entirely driven by Somatuline not facing as high erosion as you had anticipated and what this could mean for 2026, given your expectation that generics could ramp up over next year? Could margins decline year on year? Any commentary would be great. Thank you.

Speaker #4: I'm just wondering how that can compare to your assumption behind the guidance at $125. And given the degree of margin expansion guidance between 1 and 3, can we assume this is entirely driven by some actually not facing as high erosion as you had anticipated?

Speaker #4: And what could this mean for 2026, given your expectation that generics could ramp up over the next year? Could margins decline year on year?

Speaker #4: Any commentary would be great . Thank you .

David Loew: Thank you, Charles. Perhaps I start with the market dynamics of Dysport. Then I hand over to Aymeric for the Dysport phasing estimation and the assumptions on the more limited impact on Somatuline. Regarding market dynamics, we see that we're performing well, Galderma and ourselves, in the territories that we have in the aesthetic market. We see market share gains in the US. Performance is also very well in Europe. Ryzneuta has just started with the launch. It's a little bit early to comment on this one. We're very satisfied with the Dysport performance. On Dysport phasing, I hand over to Aymeric, also for the Somatuline impact assumptions for Q4.

David Loew: Thank you, Charles. Perhaps I start with the market dynamics of Dysport, and then I hand over to Aymeric for the Dysport phasing estimation and the assumptions on the more limited impact on Somatuline. Regarding market dynamics, we see that we're performing well, Galderma and ourselves, in the territories that we have in the aesthetics market. We see market share gains in the U.S., and performance is also very well in Europe. Ralphadis has just started with the launch, so it's a little bit early to comment on this one, but we're very satisfied with the Dysport performance. On Dysport phasing then, I hand over to Aymeric and also for the Somatuline impact assumptions for Q4.

Speaker #3: Thank you, Charles. Perhaps I will start with the market dynamics of this board, and then I will hand over to Emerich for the Dysport-facing estimation and the assumptions on the more limited impact on Methylin regarding market dynamics. We see that we're performing well.

Speaker #3: Galderma and ourselves in the territories that we have in the aesthetics market. We see market share gains in the U.S., and performance is also very strong in Europe.

Speaker #3: Ralph has just started with the launch, so it's a little bit early to comment on this one, but we're very satisfied with Dysport's performance on Dysport phasing.

Speaker #3: Then I hand over to Emerich and also for the Somatuline impact assumptions for Q4.

Aymeric Le Chatelier: Yeah. Thank you, David. Charles, to answer your questions, yes, the Dysport performance, as you see, we're delivering a very solid, over 9% growth both on the quarter and year-to-date, and this is really our guidance for Dysport to continue to deliver high single digits. Having said that, if you look quarter by quarter, we are impacting by phasing of shipments. I will say both on the therapeutic and the aesthetic, we believe that both therapeutic and aesthetic will continue to perform very well. David was talking about the aesthetic performance. I think on the therapeutic also, we're confident. You see the US continue to deliver double digits. I think the rest of the world has been impacted by Brazil, the Q3 was really strong with some catch-up.

Aymeric Chatelier: Yeah, thank you, David. Charles, to answer your questions, yes, the Dysport performance, as you see, we're delivering a very solid over 9% growth, both on the quarter and year to date. This is really our guidance for Dysport to continue to deliver high single digit. If you look quarter by quarter, we are impacted by phasing of shipments. I will say both on the therapeutic and the aesthetic, we believe that both therapeutic and aesthetic will continue to perform very well. David was talking about the aesthetic performance. I think on the therapeutic also, we're confident. You see the U.S. continue to deliver double digit. I think the rest of the world has been impacted by Brazil. The Q3 was really strong with some catch-up. I think it should normalize in Q4, but overall we're pretty strong here. On the aesthetic side, there is also some shipment issue.

Speaker #5: Yes . Thank you David . So , Charles , to answer your questions , yes , the performance , as you see , we're delivering a very solid over 9% growth , both on the quarter and year to date .

Speaker #5: And this is really our guidance for Dysport to continue to deliver high single digits. Having said that, if you look quarter by quarter, we are impacted by facing a shipment.

Speaker #5: So, I would say both in the therapeutic and the aesthetic segments. We believe that both therapeutic and aesthetic will continue to perform very well.

Speaker #5: David was talking about the aesthetic performance , I think , on the therapeutic . Also , we're confident you see the US continue to deliver double digit .

Speaker #5: I think the rest of the world has been impacted by Brazil . So the Q3 was really strong with some catch up . I think it should normalize in Q4 , but overall we are pretty strong here .

Aymeric Le Chatelier: I think it should normalize in Q4, but overall, we are pretty strong here. On the aesthetic side, there is also some shipment issue. As you know, we're shipping to Galderma, our partner, and depending on the phasing of shipment, the level of inventory also at the end of last year, this is significantly impacting. As you see, the overall performance for the first 9 months is minus 13%, and I think that all of that, not to say more than that, is related to phasing and shipments. That was your first question. Regarding your second question, I think there is a lot of question into your question, which is really trying to understand better the assumption behind our guidance and potentially what could be the impact for 2026 on the group profitability.

Speaker #5: On the aesthetic side , there is also some shipment issue , as you know , we're shipping to Galderma or partner and depending on the phasing of shipment , the level of inventory also at the end of last year , this is significantly impacting .

Aymeric Chatelier: As you know, we're shipping to Galderma, our partner, and depending on the phasing of shipment, the level of inventory also at the end of last year, this is significantly impacting. As you see, the overall performance for the first nine months is minus 13%. All of that, not to say more than that, is related to phasing and shipments. That was your first question. Regarding your second question, I think there is a lot of questions into your question, which is really trying to understand better the assumption behind our guidance and potentially what could be the impact for 2026 on the group profitability. I think you're right to say that today upgraded guidance is to a large extent related to the better performance of Somatuline.

Speaker #5: So, as you see, the overall performance for the first nine months is -13%. I think that all of that, not to say more than that, is related to phasing.

Speaker #5: And shipment . So that was your first question . Regarding your second question , I think there is a lot of question into your question , which is really trying to understand better the assumption behind or guidance and potentially what could be the impact for 2026 on on the group profitability .

Aymeric Le Chatelier: I think you're right to say that today upgraded guidance is to a large extent related to the better performance of Somatuline. We were anticipating that there will be more generic to come in the market, and there will be also more impact of the existing generic on both the US and the EU. Today, we see a much slower erosion than what we anticipated. This is the reason why our guidance on sales has been increased, and this is also what you see as a translation in our core operating income. This is combined with some other impact. The rest of the portfolio continue to perform pretty well, and David was talking about IQIRVO, and also we get some other revenue that are very strong in 2025.

Speaker #5: So, I think you're right to say that today, upgraded guidance is, to a large extent, related to the better performance of Somatuline.

Aymeric Chatelier: We were anticipating that there will be more generics to come in the market, and there will be also more impact of the existing generics on both the U.S. and the EU. Today we see a much slower erosion than what we anticipated. This is the reason why our guidance on sales has been increased. This is also what you see as a translation in our core operating income. This is combined with some other impact. The rest of the portfolio continues to perform pretty well. David was talking about Iqirvo, and also we get some other revenue that are very strong in 2025.

Speaker #5: We were anticipating that there will be more generics to come in the market, and there will also be more impact of the existing generics on both the US and the EU.

Speaker #5: Today, we see much slower erosion than what we anticipated. So, this is the reason why our guidance on sales has been increased.

Speaker #5: And this is also what you see as a translation in our core operating income. This is combined with some other impacts. The rest of the portfolio continues to perform pretty well.

Speaker #5: And David was talking about Iqirvo. We also see some other revenue that is very strong in 2025, going into 2026.

Aymeric Chatelier: Going into 2026, as you know, I'm not going to provide the guidance for 2026, but we are comfortable with the momentum that we have on the rest of the portfolio, even if there were to be more impact of generic potentially, because as David said, it's very difficult to predict because the product is complicated to manufacture. We believe we will be able to continue to grow, but should the pressure and erosion from generics be more important in 2026, we should see some lower level of profitability in 2026 than the 35% that we are guiding for this year. We'll provide more detailed numbers in February when we provide the guidance for 2026. Hope it answers your several questions on Somatuline.

Aymeric Le Chatelier: Going into 2026, as you know, I'm not gonna provide the guidance for 2026, but we are comfortable with the momentum that we have on the rest of the portfolio. Even if there were to be more impact of generic potentially, because as David said, it's very difficult to predict, because the product is complicated to manufacture. We believe we will be able to continue to grow. Should the pressure and erosion from generic be more important in 2026, we should see some lower level of profitability in 2026 than the 35% that we are guiding for this year. We'll provide more detailed numbers in February when we provide the guidance for 2026. Hope it answer your several questions on Somatuline.

Speaker #5: As you know , I'm not going to provide the guidance for 2026 , but we are comfortable with the momentum that we have on the rest of the portfolio , even if they were to be more impact of generic , potentially because , as David said , it's very difficult to predict because the product is complicated to manufacture .

Speaker #5: We believe we will be able to continue to grow, but should the pressure and erosion from generics be more pronounced in 2026, we should see a lower level of profitability in 2026 than the 35% that we are guiding for this year.

Speaker #5: We'll provide more detailed numbers in February when we provide the guidance for 2026. Hope it answers your several questions on perfect.

Charles Pitman-King: Perfect. Thank you so much.

[Analyst]: Perfect. Thank you so much.

Speaker #4: Thank you so much .

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Simon Baker from Rothschild & Co Redburn. Please go ahead. Your line is open.

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move on to our next question. Our next question comes from the line of Simon Baker from Rothschild & Co. Redburn.

Speaker #2: Please go ahead. Your line is open.

Simon Baker: Thank you very much for taking my questions. Two and a half, if I may, please. Firstly, on ImCheck and the impressive ICT01. I just wonder if you could share your thoughts, not only on the potential in the lead indication AML, but it's also in development for DLBCL, mantle cell lymphoma, and multiple myeloma. Are they areas of equal interest? Would they be areas that you would promote on your own, or would be the potential for partnership there? Secondly, looking at the FOP opportunity for fidrisertib, I just wonder how that's changed, if at all, in light of the Regeneron garetosmab data. Finally, just a quick one.

[Analyst]: Thank you very much for taking my questions. Two and a half, if I may, please. Firstly, on Imcheck and the impressive ICT01, I just wonder if you could share your thoughts, not only on the potential in the lead indication AML, but it's also in development for DLBCL, mantle cell lymphoma, and multiple myeloma. Are they areas of equal interest? Would they be areas that you would promote on your own, and would there be the potential for partnership there? Secondly, looking at the FOB opportunity for Fidrisertib, I just wonder how that's changed, if at all, in light of the Regeneron GlutaSMAP data. Finally, just a quick one. We're starting to see a gentle stream of letters doing deals with the White House on drug pricing. I just wondered if you could give us an update on your own experiences there. Thanks so much.

Speaker #6: Thank you very much for taking my questions . Two and a half . If I may please . Firstly , on on Memcheck and the the impressive ICO one , I just wonder if you could share your your thoughts not only on the potential in the lead indication AML , but it's also in development for DLBCL , mantle cell lymphoma and multiple myeloma .

Speaker #6: Are there areas of equal interest? Would they be areas that you would promote on your own, or would there be potential for partnership?

Speaker #6: There ? Secondly , looking at the FOP opportunity for Fedratinib , I just wonder how that's changed , if at all , in light of the Regeneron agree Mab data .

Speaker #6: And then finally, just a quick one. We're starting to see a gentle stream of letters doing deals with the White House on drug pricing.

Simon Baker: We're starting to see a gentle stream of letters doing deals with the White House on drug pricing. I just wondered if you could give us an update on your own experiences there. Thanks so much.

Speaker #6: I just wondered if you could give us an update on your own experiences there. Thanks very much.

David Loew: Thank you, Simon. Regarding ImCheck, we are indeed enthusiastic about this one. What we have modeled currently, which is why we determined that we wanted to make the deal, is the potential in first line unfit, really. We're not guiding on peak sales yet, obviously, because, you know, we have to now see much more data in phase IIb and III, it's a bit too early here. What I can say is, in terms of helping the modeling a bit, in the US you have about 7,000 patients which are in AML in first line unfit. Not eligible for high-dose chemotherapy. Inside of that pool, we have assumed that there will be targeted therapies coming. We have actually taken only 60% of the 7,000, which we consider eligible.

David Loew: Thank you, Simon. Regarding Imcheck, we are indeed enthusiastic about this one. What we have modeled currently, which is why we determined that we wanted to make the deal, is the potential in first-line unfit, really. We're not guiding on peak sales yet, obviously, because we have to now see much more data in phase 2b and 3. It's a bit too early here. What I can say is, in terms of helping the modeling a bit, in the U.S., you have about 7,000 patients which are in AML in first-line unfit, not eligible for high-dose chemotherapy. Inside of that pool, we have assumed that there will be targeted therapies coming. We have actually taken only 60% of the 7,000 which we consider eligible. Of course, there could be an upside. You never know how the data is going to look like.

Speaker #3: Thank you . Simon . So regarding we are indeed enthusiastic about this one . What we have modeled currently , which is why we determined that we wanted to make the deal , is the potential in first line unfit ?

Speaker #3: Really , we're not guiding on peak sales yet , obviously , because , you know , we have to now see much more data in phase to B and three .

Speaker #3: So it's a bit too early here . What I can say is in terms of helping the modeling a bit in the US , you have about 7000 patients , which are in AML in first line , unfit , not eligible for high dose .

Speaker #3: Chemotherapy and then inside of that pool , we have assumed that there will be targeted therapies coming . So we have actually taken only 60% of the 7000 , which we consider eligible .

David Loew: Of course, there could be an upside. You know, you never know how the data is gonna look like. When you take Keytruda, for example, Keytruda sometimes performs better than some of the targeted therapy. It could be that this is a conservative forecast model, but this is what we have done. We will look indeed at lifecycle management. There are ongoing trials that you mentioned, but we are also gonna look with the team once we have closed the deal at other, you know, potential lifecycle indications. Regarding the footprints to your question, I mean, remember that on TAZ, we're already present in the US, not yet outside of the US.

Speaker #3: Of course , there could be an upside . You know , you never know how the data is going to look like . And when you take Keytruda , for example , Keytruda sometimes performs better than some of the targeted therapies .

David Loew: When you take Keytruda, for example, Keytruda sometimes performs better than some of the targeted therapies. It could be that this is a conservative forecast model, but this is what we have done. We will look indeed at lifecycle management. There are ongoing trials, as you mentioned, but we are also going to look with the team once we have closed the deal at other potential lifecycle indications. Regarding the footprint to your question, remember that on TAS, we're already present in the U.S., not yet outside of the U.S. This is in oncology. That's not really a problem because oncology field forces are not that big. You're not talking like GP or high-volume specialty care here. That wouldn't be a concern for me at all.

Speaker #3: So it could be that this is a conservative forecast model, but this is what we have done. We will look indeed at lifecycle management.

Speaker #3: There are ongoing trials as you mentioned , but we are also going to look with the team once we have closed the deal at other , you know , potential lifecycle indications regarding the footprint to your question , I mean , remember that on Tass , we're already present in the US .

Speaker #3: Not yet . Outside of Europe , of of the US , but this is in oncology . That's not really a problem because oncology field forces are not that big .

David Loew: This is in oncology, that's not really a problem because oncology field forces are not that big. I mean, you're not talking like GP or high-volume specialty care here. That wouldn't be a concern for me at all. To your second question on FOP, on fedrisertib, we just need to now be patient to have the readout of the trial, and only then we can really comment regarding your question on Regeneron. Remember, the Regeneron trial was in patients in 18 years and above, and most of the progression of disease happens already much earlier, you know, already in early childhood. Our trial was including 5 years of age and above. If, you know, fedrisertib will demonstrate efficacy, then there is certainly an advantage just based on the label.

Speaker #3: I mean , you're not talking like GP or high volume specialty care here . So so that wouldn't be a concern for me at all .

David Loew: To your second question on FOP on Fidrisertib, we just need to now be patient to have the readout of the trial, and only then we can really comment regarding your question on Regeneron. Remember, the Regeneron trial was in patients in 18 years and above, and most of the progression of the disease happens already much earlier, already in early childhood. Our trial was including five years of age and above. If Fidrisertib will demonstrate efficacy, then there is certainly an advantage just based on the label. A lot of the disease has already happened up to adulthood, I would say. There is not such a big benefit after, let's say, 20 years of age because many patients are already in a wheelchair. They have already a lot of their joints locked, unfortunately. This is just something to keep in mind.

Speaker #3: To your second question on FOP, regarding field research, we just need to be patient to have the readout of the trial, and only then can we really comment regarding your question on Regeneron.

Speaker #3: Remember, the Regeneron trial was in patients 18 years and above. Most of the progression of the disease happens already much earlier.

Speaker #3: You know , already in early childhood , our trial was including five years of age and above . So if you know , if will demonstrate efficacy , then there is certainly an advantage just based on the label .

David Loew: A lot of the disease has already happened up to adulthood, I would say. There is not such a big benefit after, let's say, 20 years of age, because many patients are already in a wheelchair. They have already a lot of their joints locked, unfortunately. This is just something to keep in mind. Regarding your third questions on deals on the MFN, you will remember that the White House sent the letter to the 17 biggest pharma companies. We have seen a couple of deals right now. We heard that more deals are gonna happen. When you look at how these deals were structured, they seem to have a very similar pattern.

Speaker #3: A lot of the disease has already happened up to adulthood . I would say . So there is not such a big benefit after , let's say , 20 years of age , because many patients are already in a wheelchair .

Speaker #3: They have already a lot of their joints locked . Unfortunately . So this is just something to keep in mind . Regarding your third questions on deals on MFN , you will remember that the white House sent the letter to the 17 biggest pharma companies .

David Loew: Regarding your third question on deals on the MFN, you will remember that the White House sent the letter to the 17 biggest pharma companies. We have seen a couple of deals right now. We heard that more deals are going to happen. When you look at how these deals were structured, they seem to have a very similar pattern. We have to anticipate that perhaps at one point this is going to be a bit more common for the whole pharmaceutical industry, but it's too early really to speculate on this one. We have not been contacted so far. Thank you.

Speaker #3: We have a couple of deals right now. We heard that more deals are going to happen. When you look at how these deals were structured, they seem to have a very similar pattern.

Speaker #3: seen

David Loew: You know, we have to anticipate that perhaps at one point, this is gonna be a bit more common for the whole pharmaceutical industry, but it's too early really to speculate on this one. We have not been contacted so far.

Speaker #3: So, you know, we have to anticipate that perhaps at one point this is going to be a bit more common for the whole pharmaceutical industry.

Speaker #3: But it's too early, really, to speculate on this one. We have not been contacted so far.

Christelle Huguet: Thank you. Thanks very much.

Simon Baker: Thank you. Thanks very much.

[Analyst]: Thanks so much.

Speaker #6: Thank you. Thanks so much.

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Lucy Codrington from Jefferies. Please go ahead. Your line is open.

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Lucy Coddrington from Jefferies. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move on to our next question. Our next question comes from the line of Lucy Codrington from Jefferies.

Speaker #2: Please go ahead. Your line is open. Hi. Thank you for.

Lucy Codrington: Hi. Thank you for taking my questions. I've got 3, if that's okay. Firstly, on Decapeptyl, you commented on the competition and the pricing pressure you're facing. I just wanted to think about how you're looking at that original mid-single digit guide you'd given when outlining the midterm aims and if there's any change to that. Secondly, on Onivyde, I understand that the first line expansion is taking time, but could you give us more info about how the second line setting is performing and, you know, why growth appears to be stalling a little there? Finally, just on the Dysport migraine readouts next year, firstly, why have they taken so long to conduct? I think the readout's been delayed a year.

[Analyst]: Hi. Thank you for taking my questions. I've got three, if that's okay. Firstly, on Decapeptyl, you commented on the competition and the pricing pressure you're facing. I just wanted to think about how you're looking at that original mid-single-digit guide you'd given when outlining the mid-term aims and if there's any change to that. Secondly, on Onivyde, I understand that the first-line expansion is taking time, but could you give us more info about how the second-line setting is performing and why growth appears to be stalling a little there? Finally, just on the Dysport migraine readouts next year, firstly, why have they taken so long to conduct? I think the readout's been delayed a year. More generally, is there any reason to expect that these wouldn't work in migraine, given we know Botox does? Thank you.

Speaker #7: Taking my

Speaker #7: questions . I've got three , if that's okay . So firstly , on Decapeptyl , you've commented on the competition and pricing pressure you're facing .

Speaker #7: So, I just wanted to think about how you're looking at that original mid-single-digit guide you'd given when outlining the mid-term aims, and if there's any change to that.

Speaker #7: Secondly , on on avoid , I understand that the first line expansion is taking time , but could you give us more info about how the second line setting is performing and why growth appears to be stalling a little ?

Speaker #7: There ? And then finally , just on the Dysport migraine readouts next year . Firstly , why have they taken so long to conduct ?

Speaker #7: I think the readout has been delayed a year. And then, just more generally, is there any reason to expect that these wouldn't work in migraines?

Lucy Codrington: Just more generally, is there any reason to expect that these wouldn't work in migraine, given we know Botox does? Thank you.

Speaker #7: Wouldn't work in migraine, given we know Botox does? Thank you.

David Loew: Thank you, Lucy. On Decapeptyl, regarding competition and pricing and our guidance of having a mid-single digit, I think it's going to be a bit in the lower area of the mid-single, I would say, because we see this with the competition. For example, in China, we have some launches in the one-month segment, and in Europe, it's mostly pricing negotiation, which we have anticipated. It's actually fairly in line with our expectations. On Onivyde, regarding the first-line expansion, it's definitely harder than what we have anticipated. Second-line is not showing such a strong dynamic. We thought the real growth is going to come from the first-line. We are still looking at this from all angles, trying to do more real-world effectiveness, also some phase 4 studies, but it's definitely a bit harder than what we have anticipated. On Dysport migraine, I would actually correct that perception.

David Loew: Thank you, Lucy. On Decapeptyl, regarding competition and pricing, and our guidance of having a mid-single digits, I think, you know, it's gonna be based in the lower area of the mid-single, I would say, because we see this with the competition. For example, in China, we have some launches in the 1-month segment. In Europe, it's mostly pricing negotiation, which we have anticipated. It's actually fairly in line with our expectations. On Onivyde, regarding the first line expansion, it's definitely harder than what we have anticipated. Second line is not showing such a strong dynamic. We thought, you know, the real growth is gonna come from the first line.

Speaker #3: Thank you Lucy . So on Decapeptyl , regarding competition and pricing and our guidance of having a mid-single digit , I think , you know , it's going to be a bit in the lower area of the mid-single .

Speaker #3: I would say , because we see this with the competition . So for example , in China , we have some launches in the one month segment and in Europe it's mostly pricing negotiation , which we have anticipated .

Speaker #3: So it's it's actually fairly in line with our expectations . On Onivyde . Regarding the first line expansion , it's definitely harder than what we have anticipated .

Speaker #3: The second line is not showing such a strong dynamic. We thought, you know, the real growth is going to come from the first line.

David Loew: We are still looking at this from all angles, trying to do more real-world effectiveness, also some phase 4 studies, but it's definitely a bit harder than what we have anticipated. On Dysport migraine, I would actually correct that perception. There is no delay that you mentioned on this one year. That's wrong. We have never assumed any earlier timeline, we have consistently reported that it's gonna be mid next year, roughly. We would anticipate that it works as Botox does in chronic migraine, but you know, you run the trials, you find out if it really does. We have to just be patient for the migraine data to read out here. Thank you.

Speaker #3: So we are still looking at this from all angles , trying to do more real world effectiveness . Also , some phrase four studies , but it's definitely a bit harder than what we have anticipated on Dysport migraine .

Speaker #3: I would actually correct that perception. There is no delay that you mentioned on this one year; that's wrong. We have never assumed any earlier timeline.

David Loew: There is no delay that you mentioned on this one year. That's wrong. We have never assumed any earlier timeline. We have consistently reported that it's going to be mid-next year, roughly. We would anticipate that it works as Botox does in chronic migraine, but you run the trials, you find out if it really does. We have to just be patient for the migraine data to read out here. Thank you.

Speaker #3: So we have consistently reported that it’s going to be mid-next year. Roughly, we would anticipate that it works as Botox does in chronic migraine.

Speaker #3: But you know , you you run the trial to find out if it really does . So we have to just be patient for for the migraine data to read out here .

Lucy Codrington: Got it. Thank you. Sorry for that confusion. Thank you.

Speaker #3: Thank you .

[Analyst]: Got it. Thank you. Sorry for that confusion. Thank you.

Speaker #7: Great. Thank you. And sorry for that confusion. Thank you.

Operator: Thank you. We'll now move to our next question. Our next question comes from the line of Sophia Gray Football Nielsen from JPMorgan. Please go ahead. Your line is open.

Operator: Thank you. We'll now move to our next question. Our next question comes from the line of Sophia Graeff Buhl-Nielsen from JP Morgan. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move to our next question. Our next question comes from the line of Sophia Grafe Bull Nielsen from J.P. Morgan.

Speaker #2: Morgan . Please go ahead . Your line is open . Good afternoon . Thanks for taking my questions . Firstly , just on the land data , maybe if you could provide some insight into how you're seeing the efficacy of the profile relative to other toxins on the market beyond dysport , both at four and four weeks and six months , and then just in light of today's acquisition of Imtech and the target of starting a phase two , phase three trial next year , how are you seeing R&D spend developing into 2026 ?

[Analyst]: Good afternoon. Thanks for taking my questions. Firstly, just on the IPN10-200 data, maybe if you could provide some insight into how you're seeing the efficacy of the profile relative to other toxins on the market beyond Dysport, both at four and twelve weeks and six months. In light of today's acquisition of Imcheck Therapeutics and the target of starting a phase 2b, phase 3 trial next year, how are you seeing R&D spend developing into 2026?

Sophia Graeff Buhl-Nielsen: Good afternoon. Thanks for taking my questions. Firstly, just on the LANT data, maybe if you could provide some insight onto how you're seeing the efficacy of the profile relative to other toxins on the market beyond Dysport, both at 4 and 4 weeks and 6 months. Just in light of today's acquisition of ImCheck and the target of starting a phase IIb, phase III trial next year, how are you seeing R&D spend developing into 2026?

David Loew: Okay. I'm gonna take the first question, and then I will ask Aymeric to comment on the costs for the ImCheck Phase IIb/III spend. On Somatuline, as you know, we have compared the efficacy versus placebo, but more importantly also we had Dysport in there, and we have shown that the data looks very attractive versus both of them. I don't wanna speculate on you know cross study comparisons because you know we see differences sometimes in the trials that have been conducted a long time ago. Like a lot of the Botox and Dysport trials have been conducted a long time ago. They didn't all use the same endpoint.

David Loew: Okay. I'm going to take the first question, and then I will ask Aymeric to comment on the costs for the Imcheck phase 2/3 spend. On LANT, as you know, we have compared the efficacy versus placebo, but more importantly, also we had this word in there, and we have shown that the data looks very attractive versus both of them. I don't want to speculate on cross-study comparisons because we see differences sometimes in the trials that have been conducted a long time ago. A lot of the Botox and Dysport trials have been conducted a long time ago. They didn't all use the same endpoints. You're going to see the most recent data on Dysport, which looks very good, at the upcoming conference where we are going to submit the trial data in the first half of next year.

Speaker #3: Okay, I'm going to take the first question, and then I will ask Aymeric to comment on the costs for the inject phase to be three spend on land.

Speaker #3: So as you know , we have compared the efficacy versus placebo , but more importantly also we had this word in there and we have shown that the data looks very attractive versus both of them .

Speaker #3: I don't want to speculate on cross-study comparisons because, you know, we see differences sometimes in the trials that have been conducted a long time ago.

Speaker #3: Like a lot of the Botox and Dysport trials have been conducted a long time ago, they didn't all use the same endpoint.

David Loew: You're gonna see the most recent data on Dysport, which looks very good, at the upcoming conference where we are gonna submit the trial data in the first half of next year. I think we need to stick to these clean comparisons rather than going across study comparisons, because sometimes you also have slight underlying demographical differences, et cetera. I think we need to really look at the data as it will stand. Okay, I'll let you do cross studies if you want to do that. I would just caution you that this is always a difficult exercise to do because small underlying demographical differences can sometimes change things. We are extremely pleased with the IPN-10200 data, we have to say.

Speaker #3: So, you're going to see the most recent data on this board, which looks very good at the upcoming conference where we are going to submit the trial data in the first half of next year.

David Loew: I think we need to stick to these clean comparisons rather than going cross-study comparisons because sometimes you also have slight underlying demographical differences, etc. I think we need to really look at the data as it will stand. You can do cross-studies if you want to do that. I would just caution you that this is always a difficult exercise to do because small underlying demographical differences can sometimes change things. We are extremely pleased with the IPN10-200 data, we have to say. On Imcheck, regarding the spend dynamics, I'll let Aymeric answer.

Speaker #3: And I think we need to stick to these clean comparisons rather than going cross-study comparisons, because sometimes you also have slight underlying demographical differences, etc.

Speaker #3: . So I think we need to really look at the data as it will stand . And then , okay , I'll let you do cross studies if you want to do that .

Speaker #3: But I would just caution you that this is always a difficult exercise to do because small underlying demographic differences can sometimes change things. However, we are extremely pleased with the IP Ten 200 data.

Speaker #3: We have to say on Imtech regarding the spend dynamics.

David Loew: On ImCheck, regarding the spend dynamics, I'll let Emeric answer.

David Loew: On ImCheck, regarding the spend dynamics, I'll let Aymeric answer.

Aymeric Le Chatelier: Yeah. Regarding ImCheck, as a reminder, next year, 2026 will be mainly the launch of the phase IIb, so you should not anticipate very significant expenses. Even going forward, this is gonna be a 3 to 4 years study, so you should anticipate that this is a normal phase IIb in oncology. As a reminder, this is for us a mid-stage transaction, which is fully embedded in our guidance. When we provided the 2027 guidance of at least 32% of sales, this assume this pre-clinical but also early clinical to mid clinical, and this one is fully into our guidance or outlook for margin.

Aymeric Chatelier: Yeah. Regarding Imcheck, as a reminder, next year, 2026 will be mainly the launch of the phase 2b. You should not anticipate very significant expenses. Even going forward, this is going to be a three to four-year study. You should anticipate that this is a normal phase 3 in oncology. As a reminder, this is for us a mid-stage transaction, which is fully embedded in our guidance. When we provided the 2027 guidance of at least 32% of sales, this assumes deals preclinical, but also early clinical to mid-clinical. This one is fully into our guidance or outlook for margin.

Speaker #5: Yes . So regarding as a reminder . So next year , 2026 will be mainly the launch of the phase two B . So you should not anticipate very significant expenses .

Speaker #5: But even going forward, this is going to be a 3- to 4-year study. So you should anticipate that this is a normal phase three in oncology.

Speaker #5: And as a reminder, this is for us a mid-stage transaction, which is fully embedded in our guidance. So, when we provided the 2027 guidance of at least 32% of sales, this assumes deals in preclinical but also early clinical to meet clinical.

Speaker #5: And this one is fully into our guidance or outlook for margin.

Sophia Graeff Buhl-Nielsen: Thank you.

[Analyst]: Thank you.

Speaker #8: Thank you .

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Xian Deng from UBS. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move on to our next question. Our next question comes from the line of Jian Deng from UBS.

Speaker #2: Please go ahead. Your line is open.

Xian Deng: Hi. Thank you for taking my questions. Xian from UBS. Two questions, if I may. The first one on Somatuline, please. It's just a follow-up on the previous Somatuline question. I wonder if I could maybe push my luck a little bit. Given that we, you know, you're not expecting, you know, very limited erosion for this year. Just wondering how should we, you know, think about 2026 erosion, you know, purely from a modeling perspective. Because if I look at the consensus now without sort of basically updating after today, right? The current consensus is kind of modeling, let's say mid-teens-ish erosion for 2026, 2027.

[Analyst]: Hi. Thank you for taking that question, Xian, from UBS. Two questions, if I may. The first one on Somatuline, please. It's just a follow-up on the previous Somatuline question. I wonder if I could maybe push my luck a little bit. Given that you are not expecting very limited erosion for this year, just wondering how should we think about 2026 erosion purely from a modeling perspective? Because if I look at the consensus now without basically updating after today, the current consensus is kind of modeling, let's say, mid-teens-ish erosion for 2026, 2027. Of course, now, if this is actually coming from a much larger base in 2026, just wondering how should we actually think about the erosion in 2026 onwards. That's the first question.

Speaker #9: Hi . Thank you for taking my questions here from UBS . Two questions , if I may . The first one on smashing , please .

Speaker #9: It's just a follow up on the previous question . I wonder if I could maybe push my luck a little bit , given that we , you know , you're not expecting very limited erosion for this year .

Speaker #9: So just wondering , how should they how should we think about 2026 erosion ? You know , purely from a modeling perspective . Because if I look at the consensus now without sort of basically updating after today , right , the current consensus is kind of modeling , let's say mid-teens ish erosion for 26 , 27 .

Xian Deng: Of course now, if this is actually coming from a much larger base in 2026, just wondering how should we actually think about the erosion in 2026 onwards. That's the first question. The second one is also just wondering, you know, just to sort of to follow up on your previous comment on the R&D spending, ImCheck fully embedded. Just wondering for full year 2026, of course, understanding that you can't give guidance now, but just wondering, if you could maybe remind us some push and pulls in the R&D and SG&A into 2026. For example, the Bylvay BA study should be winding down and, are you gonna, you know, prepare some SG&A, et cetera? Yeah. Thank you very much.

Speaker #9: But of course, now if this is actually coming from a much larger base in 2026, you're just wondering how we should actually think about the erosion in 2026 onwards?

Speaker #9: So that's the first question . And the second one is also just wondering , you know , just sort of to follow up on your previous comment on the R&D spending Impactfully embedded , but just wondering , for full year 2026 , of course , understanding that you can't give guidance now , but just wondering if you could maybe remind us some push and pulls in the R&D and into 2026 .

[Analyst]: The second one is also just wondering, you know, just to follow up on your previous comment on the R&D spending impact fully embedded. Just wondering for full-year 2026, of course, understanding that you can't give guidance now, but just wondering if you could maybe remind us some push and pulls in the R&D and SG&A into 2026. For example, the BA study should be winding down, and are you going to prepare some SG&A, etc.? Thank you very much.

Speaker #9: So for example , the valve Bay study should be winding down and are you going to , you know , prepare some spend , etc.

Speaker #9: So, yeah, thank you very much.

David Loew: Very good. Thank you, Xian. On the Somatuline, as you know, of course, yes, you're pushing your luck. We're not giving guidance on 2026. Having said that, you're right that we're going to be on a higher base. I think what we also observe is that while we have to anticipate more competition coming in, the generics are really struggling with the production of the compound. You have seen Sun Pharma had the registration already since October last year, and they are nowhere to be seen in the market. We see that Pharmathen is struggling to get the volumes up. I would love to be a fly in their production building to know what's going on. Of course, we cannot know it with precision here.

David Loew: Very good. Thank you, Xian. On Somatuline, I mean, as you know, of course, yes, you're pushing your luck. We're not giving guidance on 2026. Having said that, you're right that we're gonna be on a higher base. I think what we also observe is that while we have to anticipate more competition coming in, the generics are really struggling with the production of the compound. I mean, you have seen Sun Pharma had the registration already since October last year. They are nowhere to be seen in the market. We see that Pharmathen is struggling to get the volumes up. You know, I would love to be a fly in their production buildings to know what's going on. Of course, we cannot know it with precision here.

Speaker #3: Very good . Thank you . Jan , on the mandolin I mean , as you know , of course . Yes . You're pushing your luck .

Speaker #3: We're not giving guidance on 2026 . Having said that , you're right that we're going to be on a higher base . I think what we also observe is that while we have to anticipate more competition coming in , the generics are really struggling with the production of the compound .

Speaker #3: I mean, you have seen Sun Pharma had the registration already since October last year, and they are nowhere to be seen in the market.

Speaker #3: We see that Pharmaton is struggling to get the volumes up. So, you know, I would love to be a fly on their production building to know what's going on.

Speaker #3: Of course, we cannot know it with precision here, so we just have to assume that there will be somewhat of a gradual erosion next year.

David Loew: We just have to assume that there will be somewhat of a gradual erosion next year and potentially with more competition coming in, perhaps Sun Pharma launching or getting the approval in the US next year. We just want to be carefully guiding on Somatuline, but I have to say we're very pleased with the performance of Somatuline. Regarding the push and pulls on the spend, regarding your question on R&D and SG&A, I'll let Aymeric answer on this one.

David Loew: We just have to assume that there will be somewhat of a gradual erosion next year and potentially with more competition coming in, perhaps Sun Pharma launching or getting the approval in the US next year. That we just wanna be carefully guiding on Somatuline. I have to say we're very pleased with the performance of Somatuline. Regarding the push and pulls on the spend, regarding your question on R&D and SG&A, I'll let Aymeric answer on this one.

Speaker #3: And potentially with more competition coming in , perhaps Sun Pharma launching or getting the approval in the US next year . So that we just want to be carefully guiding on Somatuline .

Speaker #3: But we are. I have to say, we're very pleased with the performance of Somatuline. Regarding the push and pulls on the spend.

Speaker #3: Regarding your question on R&D and G&A, led by Emmerich, answer on this one.

Aymeric Chatelier: Yeah. Your first question was on the R&D cost. As a reminder, we said that we wanted to get R&D as a percentage of sales to be at least at 20%. I think this acquisition of Imcheck will contribute. You have to keep in mind if we take the pull and push that some of the large phase 3 will start to be at the lower cost in 2026, as there are going to be quite a number of readouts. At the same time, we are accelerating our program in neuroscience, so you should expect a little bit more. We're still committed to continue to do more deals, early stage, mid-stage, like Imcheck. Overall, I think you should expect R&D to slightly increase from the 20% in 2026.

Aymeric Le Chatelier: Yeah. Your first question was on the R&D cost. As a reminder, we said that we wanted to get R&D as a percentage of sales to be at least at 20%. I think this acquisition of ImCheck will contribute. You have to keep in mind, if we take the pull and push that some of the large phase III will start to be at a lower cost in 2026, as they're gonna be quite a number of readouts. At the same time, we are accelerating our program in neuroscience, so you should expect a little bit more. We're still committed to continue to do more deal early stage, mid-stage, like ImCheck. Overall, I think you should expect R&D to slightly increase from the 20% in 2026.

Speaker #5: Yes . So your first question was on the R&D costs . So as a reminder , we said that we wanted to get R&D as a percentage of sales to be at least at 20% .

Speaker #5: I think this acquisition will contribute. You have to keep in mind, if we take the pull and push that some of the large Phase 3 studies will start to be at a lower cost in 2026, as there are going to be quite a number of readouts.

Speaker #5: At the same time, we are accelerating our program in neuroscience, so you should expect a little bit more. And we're still committed to continue to do more deals.

Speaker #5: Early stage, mid-stage, like in Czech. But overall, I think you should expect R&D to slightly increase from the 20% in 2026.

Aymeric Chatelier: Regarding SG&A, I think your question was aiming to, on one side, I think we have the full infrastructure in place, and today it's more delivering on the existing launches, especially Bylvay, IQIRVO, but also all the infrastructure in oncology. You should not expect a significant increase. At the same time, we're going to prepare for the launch of the potential lifecycle management of 2026. These are not going to be massive investments because clearly most of the investment is going to be more toward 2027 when we're going to be actually launching those expected lifecycle managements. Thank you.

Aymeric Le Chatelier: Regarding SG&A, I think your question was aiming to. On one side, I think we have the full infrastructure in place, and today it's more delivering on the existing launches, especially Bylvay, IQIRVO, but also all the infrastructure in oncology. You should not expect significant increase. At the same time, we're gonna prepare for the launch of the potential lifecycle management of 2026. These are not gonna be massive investments because clearly the most of the investment is gonna be more toward 2027 when we're gonna be actually launching those expected lifecycle management.

Speaker #5: Regarding SG&A , I think your question was aiming to on one side , I think we have the full infrastructure in place , and today it's more delivering on the existing launches , especially Iikubo .

Speaker #5: But also all the infrastructure in oncology. You should not expect a significant increase, but at the same time, we're going to prepare for the launch of the potential lifecycle management of 2026.

Speaker #5: These are not going to be massive investments because clearly, most of the investment is going to be more toward 2027, when we're going to be actually launching those expected life management.

David Loew: Thank you.

Speaker #5: Thank you .

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Victor Floc'h from BNP Paribas Exane. Please go ahead. Your line is open.

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Victor Flock from BNP Paribas. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move on to our next question. Our next question comes from the line of Victor Floch from BNP Paribas.

Speaker #2: Please go ahead. Your line is open.

David Loew: Yeah. Thanks a lot for taking my question, Victor Flock, BNP Paribas. Maybe first one on the arbitration related to IPN10-200. Can you help us understand the range of outcomes there and whether it's reasonable to assume that the resolution of that arbitration might not immediately clarify the commercial strategy for that asset, but maybe more likely mark the beginning of a potential broader discussion on your extended collaboration on toxins with Galderma? That was my first question. My second question on M&A. Congrats for the deal, and I was basically just wondering if we should assume more deals like this one, which you are basically qualifying as mid-stage deals. Should we still assume that you're going to execute on one or two later-stage transactions in the near term? Thanks so much.

Victor Floc'h: Yeah, thanks very much for taking my question, Victor Floc'h from BNP Paribas Exane. Maybe first one on the arbitration related to IPN10200. Maybe can you help us understand the range of outcomes there and whether it's reasonable to assume that the resolution of that arbitration might not immediately clarify the commercial strategy for that asset, but maybe more likely mark the beginning of a potential broader discussion on your extended collaboration on toxin with Galderma. That was my first question. My second question on M&A. I mean, congrats for the deal, I was basically just wondering if we should assume like more deals like this one, which are that you are basically qualifying as mid-stage deals.

Speaker #10: Yeah. Thanks so much for taking my question, Victor. So maybe first one on the arbitration related to IPN Ten 200.

Speaker #10: So maybe can you help us understand the range of outcomes there ? And , and whether it's reasonable to assume that the resolution of that arbitration might not immediately clarify the commercial strategy for that asset , but maybe more likely , mark the beginning of a potential broader discussion on your extended collaboration on toxin with Galderma .

Speaker #10: So that was my first question . And then my second question on M&A . I mean , congrats for the deal . And I was basically just wondering if we should assume more deals like this one , which are that you are basically qualifying as mid-stage deals .

Victor Floc'h: Should we still assume that you're going to execute on one or two later stage transaction in the near term? Thanks so much.

Speaker #10: But should we still assume that you're going to execute on one or two later stage transactions in the near term? Thanks so much.

Aymeric Chatelier: Thank you, Victor. On the arbitration, I will not speculate what the outcome might say and the clarity that we're going to get or not get, etc. Because arbitrations can go sometimes in all different directions. That's just the character of arbitration. We expect the readout towards the end of the year. We should know more fairly soon. Obviously, we're going to then communicate on the findings on the arbitration. Not much more that I can say at this point. On M&A, you're right. We have in our strategy a mix of different deals from the preclinical to early mid-stage clinical, but also late-stage clinical. Yes, we absolutely want to do more mid-stage clinical deals like the one we have just done with Imcheck.

David Loew: Thank you, Victor. On, you know, the arbitration, I will not speculate what the outcome might say and the clarity that we're gonna get or not get and et cetera. You know, arbitrations, they can go sometimes in all different directions. That's just the character of arbitration. We expect the read out towards the end of the year, so we should know more fairly soon. Obviously we're gonna then communicate on the findings on the arbitration. Not much more that I can say at this point. On M&A, you're right. We have, in our, you know, strategy a mix of different deals from the preclinical to early mid-stage clinical, but also late stage clinical.

Speaker #3: Thank you, Victor. On the arbitration, I will not speculate on what the outcome might say and the clarity that we're going to get or not get, and etc.

Speaker #3: , because , you know , arbitrations , they can go sometimes in all different directions . That's just a character of arbitration . We expect the readout towards the end of the year .

Speaker #3: So we should know more fairly soon. And obviously, we're going to then communicate on the findings of the arbitration. So, not much more that I can say at this point on M&A.

Speaker #3: You're right . We have in our you know , strategy , a mix of different deals from the pre-clinical to early mid-stage clinical , but also late stage clinical .

David Loew: Yes, we absolutely wanna do more mid-stage clinical deals like the one we have just done with ImCheck. We are also absolutely looking at late stage deals or on market deals because, you know, we wanna make sure that we can continue to expand our pipeline and our footprint in oncology, but potentially also in rare disease. In neuroscience, you have just seen us with the long-acting neurotoxin results. Clearly we are looking at late stage deals and we have ample firepower still even after this ImCheck deal because we included that, as Aymeric said, we included that in our guidance already. This is not changing in any way our guidance, the ImCheck deal.

Speaker #3: And yes , we absolutely want to do more mid-stage clinical deals like the one we have just done with Imtech . But we are also absolutely looking at late stage deals or on market deals because , you know , we want to make sure that we can continue to expand our pipeline and our footprint in oncology .

Aymeric Chatelier: We are also absolutely looking at late-stage deals or on-market deals because we want to make sure that we can continue to expand our pipeline and our footprint in oncology, but potentially also in rare disease. In neuroscience, you have just seen us with the long-acting neurotoxin results. Clearly, we are looking at late-stage deals, and we have ample firepower still even after this Imcheck deal because we included that, as Aymeric Chatelier said, we included that in our guidance already. This is not changing in any way our guidance. The Imcheck deal, it would be the case if we would do a late-stage large deal, then it might influence our guidance. Thank you.

Speaker #3: But potentially also in rare disease and in neuroscience . You have just seen us with the long acting neurotoxin results . So clearly we are looking at late stage deals and we have ample firepower .

Speaker #3: Still , even after this deal , because we included that . As Emerich said , we included that in our guidance already . So this is not changing in any way .

Speaker #3: Our guidance , the Imject deal , it would be the case if we do , would do a late stage large deal , then it might influence our guidance .

David Loew: It would be the case if we would do a late stage, large deal, then it might influence our guidance. Thank you.

Speaker #3: Thank you .

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move on to our next question. Our next question comes from the line of Florence Cespedes from Bernstein.

Speaker #2: Please go ahead. Your line is open.

Aymeric Le Chatelier: Good afternoon, everyone. Florent Cespedes from Bernstein. Thank you very much for taking my questions. Two quick ones, please. First of all, on ImCheck acquisition. I have a question on the product ICT01, the tolerance profile, we see some neutropenia infections. I was just wondering whether this could potentially impact the expansion of the product on different population, notably on less severe patients. Having a product with some different side effects, how does this could potentially impact the future potential of the product? That's my first question. Second question, an easy one. When I look at the measure coming milestones for 2026, I don't see Tazverik on the list on the updated slide. Some comments on this would be great. Thank you.

Florent Cespedes: Good afternoon, everyone. Florent Cespedes from Bernstein. Thank you very much for taking my questions. Two quick ones, please. First of all, on ImCheck acquisition. I have a question on the product ICT01, the tolerance profile, we see some neutropenia infections. I was just wondering whether this could potentially impact the expansion of the product on different population, notably on less severe patients. Having a product with some different side effects, how does this could potentially impact the future potential of the product? That's my first question. Second question, an easy one. When I look at the measure coming milestones for 2026, I don't see Tazverik on the list on the updated slide. Some comments on this would be great. Thank you.

[Analyst]: Good afternoon, everyone. Florent Cespedes from Bernstein. Thank you very much for taking my questions. Two quick ones, please. First of all, on Imcheck acquisition, I have a question on the product ICT01, the tolerance profile with the neutropenia infections. I was just wondering whether this could potentially impact the expansion of the product on different populations, notably on less severe patients. I think a product with these kinds of side effects, how this could potentially impact the future potential of the product? That's my first question. The second question, an easy one. When I look at the major coming milestones for 2026, I don't see Tovorafenib on the list on the updated slide. Some comments on this would be great. Thank you.

Speaker #11: Good afternoon everyone . Florence Cespedes from Bernstein . Thank you very much for taking my questions . Two quick ones , please . First of all , on in acquisition , I have a question on the product .

Speaker #11: ICT zero one . The tolerance profile . We see some neutropenia infections . I was just wondering whether this could potentially impact the expansion of the product on a different population , notably on less severe patients .

Speaker #11: So, having a product with this kind of side effects, how could this potentially impact the future potential of the product? That's my first question.

Speaker #11: And the second question , an easy one . When I look at the major milestones for 2026 , I don't see a tazverik on the list on the updated slide .

Speaker #11: So some comments on this would be great . Thank you .

David Loew: Thank you, Florent. I will actually give both questions to Christelle Huguet, our Head of R&D.

David Loew: Thank you, Florent. I will actually give both questions to Christelle Huguet, our head of R&D.

Speaker #3: Thank you, Florent. So I will actually give both questions to Christelle Huguet, our Head of R&D.

Christelle Huguet: Thank you for the question, Florent. Let's start with ICT01. When you look at the EVICTION trial and you look at the safety profile, it's in fact very well in line with the safety profile of venetoclax plus azacitidine in the AML population. In fact, it appears that ICT01 does not add to the safety profile and is well tolerated in those patients. To your second question regarding Tazverik. The SYMPHONY-1 trial is doing well and will be fully enrolled by the end of the year. As you will remember, this is an event-driven readout, and from what we can gather in early interim look, we think that it's going to read out towards the very late end of last year and maybe fall into the Q1 of 2027.

Christelle Huguet: Thank you for the question, Florent. Let's start with ICT01. When you look at the Eviction trial and you look at the safety profile, it's in fact very well in line with the safety profile of venetoclax plus azacitidine in the acute myeloid leukemia population. It appears that ICT01 does not add to the safety profile and is well tolerated in those patients. To your second question regarding Tovorafenib, the Symphony One trial is doing well and will be fully enrolled by the end of the year. As you will remember, this is an event-driven readout. From what we can gather in early interim look, we think that it's going to read out towards the very late end of last year and maybe fall into the first quarter of 2027. That's why you're not seeing it on the pipeline for 2026. However, the study is going well.

Speaker #12: Thank you for the question , Florent . So let's start with ICT oh one . So when you look at the eviction trial and you look at the safety profile , it's in fact very well in line with the safety profile of Venetoclax plus Azacitidine in the AML population .

Speaker #12: So, in fact, it appears that ICT-1 does not add to the safety profile and is well tolerated in those patients. To your second question regarding Tazverik.

Speaker #12: So the Symphony one trial is is doing well and will be fully enrolled by the end of the year , as you will remember , this is an event driven readout .

Speaker #12: And from what we can gather in early interim, look, we think that it's going to read out towards the very late end of last year.

Speaker #12: And maybe it will fall into the first quarter of 2027. That's why you're not seeing it on the pipeline for 2026. However, the study is going well.

Christelle Huguet: That's why you're not seeing it on the pipeline for 26. However, the study is going well.

David Loew: Good. Thank you very much. Very clear.

Speaker #11: Good. Thank you very much. Very clear.

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Natalia Webster from RBC Capital Markets. Please go ahead. Your line is open.

Speaker #2: Thank you. We'll now move on to our next question. Our next question comes from the line of Natalia Webster from RBC Capital Markets.

Speaker #2: Please go ahead . Your line is open . Hi there . Thanks for taking my .

Natalia Webster: Hi there. Thanks for taking my questions. Firstly, just to follow up on your SG&A investment into the IQIRVO and Bylvay launches. Q3 sales are stronger for both of those. I was just wondering if you're able to comment on the impact you're seeing from the investment in your sales force for both of those products in Q3, how you expect that to progress in Q4 and into 2026. Secondly, specifically for IQIRVO, you said that you're anticipating the US withdrawal of OCALIVA to benefit sales from Q4. Are you able to comment on how you expect this benefit to be split between IQIRVO and competitor Livdelzi? Thank you.

[Analyst]: Hi there. Thanks for taking my questions. Firstly, just to follow up on your SG&A investment into the Iqirvo and Bylvay launches. Q3 sales are stronger for both of those. I was just wondering if you're able to comment on the impact you're seeing from the investment in your sales force for both of those products in Q3, and how you expect that to progress in Q4 and into 2026. Secondly, specifically for Iqirvo, you said that you're anticipating the U.S. withdrawal of Ocaliva to benefit sales from Q4. Are you able to comment on how you expect this benefit to be split between Iqirvo and competitor Livedelsi? Thank you.

Speaker #7: Questions .

Speaker #2: Firstly, just to follow up.

Speaker #13: On your SG&A investment into Iqirvo and Bylvay launches at Q3, sales were stronger for both of those. So I was just wondering if you're able to comment on the impact you're seeing from the investment in your sales force for both of those products in Q3, and then how you expect that to progress in Q4 and into 2026.

Speaker #13: And then secondly, specifically for Iqivio, you said that you're anticipating the US withdrawal of Ocaliva to benefit sales from Q4. Are you able to comment on how you expect this benefit to be split between it and competitor Lived?

Speaker #13: LC thank you .

David Loew: Thank you, Natalia. On the investment of IQIRVO, we have indeed invested, you know, adequately, I would say the push on IQIRVO because we are very excited about the product, and we have seen a very, very nice pickup of IQIRVO and also Bylvay. What we have done is we have split out Bylvay pediatric indication to a dedicated pediatric team force as of October. Now, they are just being on the territory now. That gives, of course, by the simple arithmetics a bit more share of voice for the IQIRVO team force because they were also taking care of Bylvay there. I think we are going to continue seeing a positive momentum on IQIRVO and Bylvay for the future.

David Loew: Thank you, Natalia. On the investment of Iqirvo, we have indeed invested adequately, I would say, the push on Iqirvo because we are very excited about the product. We have seen a very, very nice pickup of Iqirvo and also Bylvay. What we have done is we have split out the Bylvay pediatric indications. We have dedicated pediatric field force as of October. They're just being on the territory now. That gives, of course, by the simple arithmetic, a bit more share of voice for the Iqirvo field force because they were also taking care of Bylvay there. I think we are going to continue seeing a positive momentum on Iqirvo and Bylvay for the future.

Speaker #3: Thank you , Natalia . On the investment of I Cuervo . So we have indeed invested , you know , adequately . I would say the push on because we are very excited about the product and we have seen a very , very nice pickup of Corvo and also Bylvay what we have done is we have split out the Bylvay pediatric indication to a dedicated pediatric speed force .

Speaker #3: As of October . Now they're just being on the territory now , and that gives of course , by the simple arithmetic's a bit more share of voice for the field force because they were also taking care of their so I think we are going to continue seeing a positive momentum on and will be for the future .

David Loew: Regarding your second question on the Ocaliva withdrawal and the split, I think, honestly, we're going to probably see a similar pickup of these Ocaliva patients in line with the market shares that we are seeing right now. I would say that the fatigue data has definitely helped us continuously seeing an acceleration as well on Iqirvo and being very competitive in the field here. We're very pleased with the performance so far.

David Loew: Regarding your second question on the OCALIVA withdrawal and the split, I think honestly, we're gonna probably see a similar pickup of these OCALIVA patients in line with the market shares that we are seeing right now. I would say that, the fatigue data has definitely helped us, you know, continuously seeing an acceleration as well on IQIRVO and being very competitive in the field here. We're very pleased with the performance so far.

Speaker #3: Regarding your second question on the Ocaliva withdrawal and the split, I think honestly we're going to probably see a similar pickup of these Ocaliva patients in line with the market shares that we are seeing right now.

Speaker #3: I would say that the fatigue data has definitely helped us. You know, we are continuously seeing an acceleration as well on Corvo and being very competitive in the field here.

Speaker #3: So, we're very pleased with the performance so far.

Natalia Webster: Thank you.

[Analyst]: Thank you.

Speaker #13: Thank you .

Operator: Thank you. There are no further questions at this time. I'll hand the call back to David for closing remarks.

Speaker #2: Thank you. There are no further questions at this time, so I'll hand the call back to David for closing remarks.

David Loew: Thank you very much, everybody, and have a good rest of your day. Bye-bye.

Speaker #3: Thank you very much, everybody, and have a good rest of your day. Bye-bye.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.

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