Q4 2025 Ipsen SA Earnings Call
Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press *11 on your telephone.
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Speaker #1: I will now like to hand the conference over to your speaker today, David Loew, IPSEN CEO. Please go ahead.
Speaker #2: Thank you, Operator, and hello everyone. I'm delighted to welcome you to our presentation this afternoon, which can also be found on ipsen.com. I want to use the time we have together to focus on the progress IPSEN delivered in 2025 and on the future opportunities and platforms for growth.
David Loew: Thank you, operator, and hello, everyone. I'm delighted to welcome you to our presentation this afternoon, which can also be found on Ipsen.com. I want to use the time we have together to focus on the progress Ipsen delivered in 2025 and on the future opportunities and platforms for growth. Please turn to slide 2. Please take note of our forward-looking statements, which outline the routine risks and uncertainties contained within this presentation. Also, 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 the presentation of our latest business update, followed by our CFO, Aymeric Le Châtelier, who will take you through the financials, and finally, I will provide an R&D update. At the end of the presentation, we will open the Q&A session. Let's begin by looking at today's highlights.
David Loew: Thank you, operator, and hello, everyone. I'm delighted to welcome you to our presentation this afternoon, which can also be found on Ipsen.com. I want to use the time we have together to focus on the progress Ipsen delivered in 2025 and on the future opportunities and platforms for growth. Please turn to slide 2. Please take note of our forward-looking statements, which outline the routine risks and uncertainties contained within this presentation. Also, 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 the presentation of our latest business update, followed by our CFO, Aymeric Le Châtelier, who will take you through the financials, and finally, I will provide an R&D update. At the end of the presentation, we will open the Q&A session. Let's begin by looking at today's highlights.
Speaker #2: Please turn to slide two. Please take note of our forward-looking statements, which outline the routine risks and uncertainties contained within this presentation. Also, all of my comments on growth will be based on constant exchange rates.
Speaker #2: Please turn to slide three. I'm going to take you through the presentation of our latest business update, followed by our CFO, Aymeric Chatelier, who will take you through the financials and finally, I will provide an R&D update.
Speaker #2: At the end of the presentation, we will open the Q&A session. Let's begin by looking at today's highlights. Please turn to slide four. Turn to slide five.
David Loew: Please turn to slide 4. Turn to slide 5. Today's headlines illustrates how we are continuing to deliver strong and sustainable growth. In 2025, total sales grew double digits by 10.9%. A performance driven mostly by the strong performance of our portfolio, excluding Somatuline, which grew by 14.2% over the year. Regarding margin, we delivered a core operating margin of 35.2% of total sales. Turning to regulatory highlights, this year was marked by the EMA regulatory submission of tovorafenib for pediatric low-grade glioma in Q1, EU approval of CABOMETYX in neuroendocrine tumors in July, and importantly, by the announcement of the first data for our first-in-class, differentiated, long-acting molecule, IPN10200, in September.
David Loew: Please turn to slide 4. Turn to slide 5. Today's headlines illustrates how we are continuing to deliver strong and sustainable growth. In 2025, total sales grew double digits by 10.9%. A performance driven mostly by the strong performance of our portfolio, excluding Somatuline, which grew by 14.2% over the year. Regarding margin, we delivered a core operating margin of 35.2% of total sales. Turning to regulatory highlights, this year was marked by the EMA regulatory submission of tovorafenib for pediatric low-grade glioma in Q1, EU approval of CABOMETYX in neuroendocrine tumors in July, and importantly, by the announcement of the first data for our first-in-class, differentiated, long-acting molecule, IPN10200, in September.
Speaker #2: Today's headlines illustrate how we are continuing to deliver strong and sustainable growth. In 2025, total sales grew double digits by 10.9%, a performance-driven mostly by the strong performance of our portfolio excluding some atelier, which grew by 14.2% over the year.
Speaker #2: Regarding margin, we delivered a core operating margin of 35.2% of total sales. Turning to regulatory highlights, this year was marked by the EMA regulatory submission of Tovora Philippe for pediatric low-grade glioma in the first quarter, EU approval of Carbomatics in neuroendocrine tumors in July, and importantly, by the announcement of the first data for our first-in-class differentiated long-acting molecule IPN10200 in September.
Speaker #2: Looking ahead, 2026 promises to be another exciting year for our pipeline with key five key milestones, which includes three pivotal readouts in addition to the highly anticipated full data presentation of the phase two data for IPN10200 in first aesthetics indication, global alliance, at an upcoming medical meeting.
David Loew: Looking ahead, 2026 promises to be another exciting year for our pipeline, with 5 key milestones, which includes 3 pivotal readouts, in addition to the highly anticipated full data presentation of the Phase II data for IPN10200 in first aesthetics indication, glabellar lines, at an upcoming medical meeting. Lastly, we are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and a better outlook for Somatuline, given the production challenges faced by generic competition. Aymeric will provide more details in his section. Please turn to slide 6. Our full-year sales delivered a solid 10.9% growth and 7.5% in Q4, fueled by all three therapeutic areas, with an improvement of performance for neuroscience and rare disease this year compared to last year.
David Loew: Looking ahead, 2026 promises to be another exciting year for our pipeline, with 5 key milestones, which includes 3 pivotal readouts, in addition to the highly anticipated full data presentation of the Phase II data for IPN10200 in first aesthetics indication, glabellar lines, at an upcoming medical meeting. Lastly, we are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and a better outlook for Somatuline, given the production challenges faced by generic competition. Aymeric will provide more details in his section. Please turn to slide 6. Our full-year sales delivered a solid 10.9% growth and 7.5% in Q4, fueled by all three therapeutic areas, with an improvement of performance for neuroscience and rare disease this year compared to last year.
Speaker #2: Lastly, we are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and the better outlook for some atelier, given the production challenges faced by generic competition.
Speaker #2: Aymeric will provide more details in his section. Please turn to slide six. Our full-year sales delivered a solid 10.9% growth and 7.5% in Q4, fueled by all three therapeutic areas, with an improvement of performance for neuroscience and rare disease this year compared to last year.
Speaker #2: The portfolio, excluding some atelier, grew at 14.2% this year and by 19.6% in Q4. Oncology performed well, with sales growth of 4.1%, but were down in the last quarter due to a decline in some atelier sales versus a very high baseline in 2024.
David Loew: The portfolio, excluding Somatuline, grew at 14.2% this year and by 19.6% in Q4. Oncology performed well, with sales growth of 4.1%, but were down in the last quarter due to a decline in Somatuline sales versus a very high baseline in 2024. Rare disease performed very well, with sales doubling this year. Neuroscience, with Dysport, continued to deliver high single-digit growth. I'll now turn to Oncology for more detail. Please turn to slide 7. Starting with Somatuline, sales were up by 4.3% for the full year. Both Europe and the US continued to benefit from shortages of generic lanreotide, and we saw a strong performance in rest of world.
David Loew: The portfolio, excluding Somatuline, grew at 14.2% this year and by 19.6% in Q4. Oncology performed well, with sales growth of 4.1%, but were down in the last quarter due to a decline in Somatuline sales versus a very high baseline in 2024. Rare disease performed very well, with sales doubling this year. Neuroscience, with Dysport, continued to deliver high single-digit growth. I'll now turn to Oncology for more detail. Please turn to slide 7. Starting with Somatuline, sales were up by 4.3% for the full year. Both Europe and the US continued to benefit from shortages of generic lanreotide, and we saw a strong performance in rest of world.
Speaker #2: Rare disease performed very well, with sales doubling this year. Neuroscience, with this sport, continued to deliver high single-digit growth. I'll now turn to oncology for more detail.
Speaker #2: Please turn to slide seven. Starting with some atelier, sales were up by 4.3% for the full year, both Europe and the US continued to benefit from shortages of generic lanreotide and we saw a strong performance in rest of the world.
Speaker #2: As we have previously communicated, we are aware of recent updates on the potential challenges with regards to the manufacturing and availability of generic lanreotide in several markets, and this is factored into our guidance.
David Loew: As we have previously communicated, we are aware of recent updates on the potential challenges with regards to the manufacturing and availability of generic lanreotide in several markets, and this is factored in our guidance. CABOMETYX sales were up by 5.1%, with solid performance in Europe, driven by renal cell carcinoma growth and boosted by the neuroendocrine tumor launch, despite increased competition in rest of world. Decapeptyl sales were up by 2.7%, as we experienced volume growth in Europe and China, despite continuous competition and some pricing pressure in some countries. Onivyde sales grew by 6.2%, with expansion of use in the US, driven by the first-line metastatic pancreatic ductal adenocarcinoma indication. We expect sales to continue to grow modestly, but acknowledge that we are now unlikely to reach EUR 500 million in peak sales.
David Loew: As we have previously communicated, we are aware of recent updates on the potential challenges with regards to the manufacturing and availability of generic lanreotide in several markets, and this is factored in our guidance. CABOMETYX sales were up by 5.1%, with solid performance in Europe, driven by renal cell carcinoma growth and boosted by the neuroendocrine tumor launch, despite increased competition in rest of world. Decapeptyl sales were up by 2.7%, as we experienced volume growth in Europe and China, despite continuous competition and some pricing pressure in some countries. Onivyde sales grew by 6.2%, with expansion of use in the US, driven by the first-line metastatic pancreatic ductal adenocarcinoma indication. We expect sales to continue to grow modestly, but acknowledge that we are now unlikely to reach EUR 500 million in peak sales.
Speaker #2: Carbomatic sales were up by 5.1%, with solid performance in Europe, driven by renal cell carcinoma growth and boosted by the neuroendocrine tumor launch, despite increased competition in the rest of the world.
Speaker #2: Decapeptyl sales were up by 2.7%, as we experienced volume growth in Europe and China, despite continued competition and some pricing pressure in some countries.
Speaker #2: Onivite sales grew by 6.2%, with expansion of use in the US driven by the first-line metastatic pancreatic ductal adenocarcinoma indication. We expect sales to continue to grow modestly, but acknowledge that we are now unlikely to reach €500 million in peak sales.
Speaker #2: Now let's turn to rare disease. Let's go to slide eight. On rare disease, Bill Bay continues to perform well with annual sales of 180 million euro, growing by 36.3%.
David Loew: Now, let's turn to rare disease. Let's go to slide 8. On rare disease, Bylvay continues to perform well, with annual sales of EUR 180 million, growing by 36.3%. Growth was driven by both PFIC and Alagille syndrome indications in the US. Additionally, we saw a strong double-digit growth in both Europe and in rest of world. Q4 sales growth was impacted by ongoing competitive challenges in the PFIC indication, and we expect to see the positive effects of the new pediatric field force we put recently in place in the coming months in the US. IQIRVO continues to track very well, with annual sales of EUR 184 million, with growth coming from all regions. Let me go into a bit more detail on the next slide. Please turn to slide 9.
David Loew: Now, let's turn to rare disease. Let's go to slide 8. On rare disease, Bylvay continues to perform well, with annual sales of EUR 180 million, growing by 36.3%. Growth was driven by both PFIC and Alagille syndrome indications in the US. Additionally, we saw a strong double-digit growth in both Europe and in rest of world. Q4 sales growth was impacted by ongoing competitive challenges in the PFIC indication, and we expect to see the positive effects of the new pediatric field force we put recently in place in the coming months in the US. IQIRVO continues to track very well, with annual sales of EUR 184 million, with growth coming from all regions. Let me go into a bit more detail on the next slide. Please turn to slide 9.
Speaker #2: Growth was driven by both PFIC and Agile Syndrome indications in the US. Additionally, we saw strong double-digit growth in both Europe and the rest of the world.
Speaker #2: Q4 sales growth was impacted by ongoing competitive challenges in the PFIC indication, and we expect to see the positive effect of the new pediatric field force we put recently in place in the coming months in the US.
Speaker #2: IQURVO continues to track very well, with annual sales of 184 million euros, with growth coming from all regions. Let me go into a bit more detail on the next slide.
Speaker #2: Please turn to slide nine. As you can see, we have demonstrated strong quarter-on-quarter growth since the launch, just over a year and a half ago.
David Loew: As you can see, we have demonstrated strong quarter-on-quarter growth since the launch just over a year and a half ago. In the US, we have seen a significant number of Ocaliva patients switching to IQIRVO on top of a growing PPAR market. We believe that the new data published at AASLD this year has further strengthened IQIRVO's profile as a drug with both long-term efficacy and safety, including improvements in pruritus, fatigue, and fibrosis. In Europe, we are continuing the launch across many countries. We're also very pleased with how well the launches are progressing, capturing new patients and contributing to expand the market. Moving to neuroscience, please turn to slide 10. Dysport delivered another year of solid performance, with sales growth of 9.7% for the full year.
David Loew: As you can see, we have demonstrated strong quarter-on-quarter growth since the launch just over a year and a half ago. In the US, we have seen a significant number of Ocaliva patients switching to IQIRVO on top of a growing PPAR market. We believe that the new data published at AASLD this year has further strengthened IQIRVO's profile as a drug with both long-term efficacy and safety, including improvements in pruritus, fatigue, and fibrosis. In Europe, we are continuing the launch across many countries. We're also very pleased with how well the launches are progressing, capturing new patients and contributing to expand the market. Moving to neuroscience, please turn to slide 10. Dysport delivered another year of solid performance, with sales growth of 9.7% for the full year.
Speaker #2: In the US, we have seen a significant number of Ocaliva patients switching to IQURVO on top of a growing PPAR market. We believe that the new data published at ASLD this year has further strengthened IQURVO's profile as a drug with both long-term efficacy and safety, including improvements in pruritus, fatigue, and fibrosis.
Speaker #2: In Europe, we're continuing the launch across many countries. We're also very pleased with how well the launches are progressing, capturing new patients and contributing to expand the market.
Speaker #2: Moving to neuroscience, please turn to slide 10. This sport delivered another year of solid performance with sales growth of 9.7% for the full year.
Speaker #2: In aesthetics, sales grew by 13.7%, driven by continued strong sales in most territories including the US and rest of the world, and by a strong performance from our partner Galderma, who continued to gain market share in key countries and a solid growth in our IPSEN territories.
David Loew: In aesthetics, sales grew by 13.7%, driven by continued strong sales in most territories, including the US and rest of the world, and by strong performance from our partner, Galderma, who continued to gain market share in key countries and a solid growth in our IPN territories. On the therapeutic side, Dysport grew by 4.2%, driven by strong growth in the US and Europe. Reported sales were, however, down in rest of world, impacted by adverse phasing of orders in Brazil. That concludes the review of sales. I'll now hand over to Aymeric, who will provide you more details on our full-year financials. Please turn to slide 11.
David Loew: In aesthetics, sales grew by 13.7%, driven by continued strong sales in most territories, including the US and rest of the world, and by strong performance from our partner, Galderma, who continued to gain market share in key countries and a solid growth in our IPN territories. On the therapeutic side, Dysport grew by 4.2%, driven by strong growth in the US and Europe. Reported sales were, however, down in rest of world, impacted by adverse phasing of orders in Brazil. That concludes the review of sales. I'll now hand over to Aymeric, who will provide you more details on our full-year financials. Please turn to slide 11.
Speaker #2: On the therapeutic side, this sport grew by 4.2%, driven by strong growth in the US and Europe. Reported sales were, however, down in the rest of the world, impacted by adverse phasing of orders in Brazil.
Speaker #2: That concludes the review of sales. I'll now hand over to Aymeric, who will provide you more details on our full-year financials. Please turn to slide 11.
Aymeric Le Chatelier: ... Thank you, David, and hello to everybody. I will now take you through more details of our 2025 financial performance and our guidance for 2026. Please turn to slide 12. We delivered another set of strong financial results this year across sales, profitability, and cash flow. First, our total sales, which exceeded EUR 3.6 billion, grew by 10.9% at constant exchange rate. Our core operating income grew by 16.7% to EUR 1.3 billion, in line with our free cash flow, increasing by 29% to reach EUR 1 billion. Given this strong performance and our solid balance sheet with no debt, we had EUR 3.2 billion of firepower available for external innovation. Let's take now a closer look at those financials in the next slide. Please turn to slide 13.
Aymeric Le Chatelier: ... Thank you, David, and hello to everybody. I will now take you through more details of our 2025 financial performance and our guidance for 2026. Please turn to slide 12. We delivered another set of strong financial results this year across sales, profitability, and cash flow. First, our total sales, which exceeded EUR 3.6 billion, grew by 10.9% at constant exchange rate. Our core operating income grew by 16.7% to EUR 1.3 billion, in line with our free cash flow, increasing by 29% to reach EUR 1 billion. Given this strong performance and our solid balance sheet with no debt, we had EUR 3.2 billion of firepower available for external innovation. Let's take now a closer look at those financials in the next slide. Please turn to slide 13.
Speaker #3: Thank you, David, and to everybody. I will now take you through more details of our 2025 financial performance and our guidance for 2026. Please turn to slide 12.
Speaker #3: We delivered another set of strong financial results this year across sales, profitability, and cash flow. First, our total sales, which exceeded 3.6 billion euro, grew by 10.9% at constant exchange rate.
Speaker #3: Our core operating income grew by 16.7% to 1.3 billion, in line with our free cash flow, increasing by 29% to reach 1 billion euro.
Speaker #3: Given the strong performance and our solid balance sheet with no debt, we had 3.2 billion euro of higher power available for external innovation. Let's take now a closer look at those financials in the next slide.
Speaker #3: Please turn to slide 13. Starting with the P&L to core operating income. I would like to highlight that we implemented this year a slight reclassification of our distribution expenses.
Aymeric Le Chatelier: Starting with the PNL to core operating income. I would like to highlight that we implemented this year a slight reclassification of our distribution expenses. These costs have been moved from SG&A to cost of sales, and therefore now impact our gross margin. This change brings our reporting in line with common practices of most of our industry peers. You have all the details in the appendix of that presentation. Now, if we look at the figures, the growth in total sales of 10.9% at constant exchange rate translated into 8.1% at current rates, given the adverse currency movements.
Aymeric Le Chatelier: Starting with the PNL to core operating income. I would like to highlight that we implemented this year a slight reclassification of our distribution expenses. These costs have been moved from SG&A to cost of sales, and therefore now impact our gross margin. This change brings our reporting in line with common practices of most of our industry peers. You have all the details in the appendix of that presentation. Now, if we look at the figures, the growth in total sales of 10.9% at constant exchange rate translated into 8.1% at current rates, given the adverse currency movements.
Speaker #3: This cost has been moved from SG&A to cost of sales and therefore now impacts our gross margin. This change brings our reporting in line with common practices of most of our industry peers, you have all the detail in the appendix of that presentation.
Speaker #3: Now, if we look at the figures, the gross in total sales of 10.9% at constant exchange rate translated into 8.1% at current rates given the adverse currency movements.
Speaker #3: Gross margin increased by 2.1 points, driven by the higher level of other revenue by 80 million, mainly due to commercial and regulatory milestones received from ex-US partners for Onivite and some other products, and the gross in royalties received primarily from this port partner.
Aymeric Le Chatelier: Gross margin increased by 2.1 points, driven by the higher level of other revenue by EUR 80 million, mainly due to commercial and regulatory milestone received from ex-US partner for ONIVYDE and some other products, and the growth in royalties received primarily from Despoc partner. SG&A costs increased by only 6.9%, with a ratio to sales at 31.6%, improving by 0.3 points, reflecting an increased investment to support the launches, especially IQIRVO and Bylvay, and the impact of our ongoing efficiency program. R&D costs increased by 9.8% to reach 20.5% of total sales, driven mainly by increased investment to support the development, mainly in neuroscience and early-stage oncology assets.
Aymeric Le Chatelier: Gross margin increased by 2.1 points, driven by the higher level of other revenue by EUR 80 million, mainly due to commercial and regulatory milestone received from ex-US partner for ONIVYDE and some other products, and the growth in royalties received primarily from Despoc partner. SG&A costs increased by only 6.9%, with a ratio to sales at 31.6%, improving by 0.3 points, reflecting an increased investment to support the launches, especially IQIRVO and Bylvay, and the impact of our ongoing efficiency program. R&D costs increased by 9.8% to reach 20.5% of total sales, driven mainly by increased investment to support the development, mainly in neuroscience and early-stage oncology assets.
Speaker #3: SG&A cost increased by only 6.9%, with a ratio to sales at 31.6%, improving by 0.3 points, reflecting an increased investment to support the launches especially IQURVO and Bill Bay, and the impact of our ongoing efficiency program.
Speaker #3: R&D cost increased by 9.8% to reach 20.5% of total sales, driven mainly by increased investment to support the development, mainly in neuroscience and early-stage oncology assets.
Speaker #3: As a consequence, our core operating income increased by 16.7%, with a core operating margin standing at 35.2%, increasing by 2.6 points. Please turn to slide 14.
Aymeric Le Chatelier: As a consequence, our core operating income increased by 16.7%, with a core operating margin standing at 35.2%, increasing by 2.6 points. Please turn to slide 14. Turning to IFRS consolidated net profit. This year, we recognized impairment losses for about EUR 350 million before tax, mainly driven by first, Tazverik, for which we no longer expect to achieve the EUR 500 million peak sales, given the recent competitive developments. Secondly, by fidrisertib, following the negative readout in December 2025 of the pivotal phase II trial. And thirdly, by the discontinuation of some of our early-stage assets. Despite this impairment, IFRS operating income and consolidated net profit increased by 26% and 28% respectively. Please turn to slide 15. Finally, on cash flow.
Aymeric Le Chatelier: As a consequence, our core operating income increased by 16.7%, with a core operating margin standing at 35.2%, increasing by 2.6 points. Please turn to slide 14. Turning to IFRS consolidated net profit. This year, we recognized impairment losses for about EUR 350 million before tax, mainly driven by first, Tazverik, for which we no longer expect to achieve the EUR 500 million peak sales, given the recent competitive developments. Secondly, by fidrisertib, following the negative readout in December 2025 of the pivotal phase II trial. And thirdly, by the discontinuation of some of our early-stage assets. Despite this impairment, IFRS operating income and consolidated net profit increased by 26% and 28% respectively. Please turn to slide 15. Finally, on cash flow.
Speaker #3: Turning to IFRS consolidated net profit. This year, we recognized impairment losses for about 350 million before tax, mainly driven by first Tasveric, for which we no longer expect to achieve the 500 million pixels given the recent competitive developments.
Speaker #3: Secondly, by fidricertib, following the negative readout in December 2025 of the pivotal Phase 2 trial. And thirdly, by the discontinuation of some of our early-stage assets.
Speaker #3: Despite those impairments, IFRS operating income and consolidated net profit increased by 26% and 28% respectively. Please turn to slide 15. Finally, on cash flow, we continue to generate strong free cash flow this year and maintain a solid balance sheet with a cash position of more than 500 million at the end of December.
Aymeric Le Chatelier: We continue to generate strong free cash flow this year and maintain a solid balance sheet with a cash position of more than EUR 500 million at the end of December. Free cash flow increased by 29% to EUR 1 billion, driven by EBITDA growth, sound management of capital expenditures, and working capital. Net investments included the acquisition of Intrecht Therapeutics for about EUR 350 million, and some regulatory and commercial milestones. As a consequence, with a net cash position of exactly EUR 560 million at the end of December, and based on the maximum of 2x net debt to EBITDA, we had an available firepower of EUR 3.2 billion for external innovation at the end of 2025. Let's now move to 2026 guidance. Please turn to slide 16.
Aymeric Le Chatelier: We continue to generate strong free cash flow this year and maintain a solid balance sheet with a cash position of more than EUR 500 million at the end of December. Free cash flow increased by 29% to EUR 1 billion, driven by EBITDA growth, sound management of capital expenditures, and working capital. Net investments included the acquisition of Intrecht Therapeutics for about EUR 350 million, and some regulatory and commercial milestones. As a consequence, with a net cash position of exactly EUR 560 million at the end of December, and based on the maximum of 2x net debt to EBITDA, we had an available firepower of EUR 3.2 billion for external innovation at the end of 2025. Let's now move to 2026 guidance. Please turn to slide 16.
Speaker #3: Free cash flow increased by 29% to 1 billion, driven by EBITDA growth, sound management of capital expenditures, and working capital. Net investments included the acquisition of ImCheck Therapeutic for about 350 million, and some regulatory and commercial milestones.
Speaker #3: As a consequence, with the net cash position of exactly €560 million at the end of December, and based on the maximum of two times net debt to EBITDA, we had an available firepower of €3.2 billion for external innovation at the end of 2025.
Speaker #3: Let's now move to 2026 guidance. Please turn to slide 16. For this year, we anticipate another year of double-digit sales growth with a high level of profitability.
Aymeric Le Chatelier: For this year, we anticipate another year of double-digit sales growth with a high level of profitability. For total sales, we expect growth of more than 13% at constant exchange rates. This year, we also anticipate adverse impact of around 2% from currency, based on the January exchange rate. This guidance on sales is assuming an accelerated sales growth of the portfolio, excluding Somatuline. This will be driven by IQIRVO, Bylvay, Dysport, but also Cabometyx, as well as a continued growth from Somatuline. Given the recent challenges with regard to the manufacturing and availability of generic lanreotide, we assume limited generic supply in 2026, with a potential entrance only in the second half of this year. On profitability now, we anticipate a core operating margin greater than 35% of total sales.
Aymeric Le Chatelier: For this year, we anticipate another year of double-digit sales growth with a high level of profitability. For total sales, we expect growth of more than 13% at constant exchange rates. This year, we also anticipate adverse impact of around 2% from currency, based on the January exchange rate. This guidance on sales is assuming an accelerated sales growth of the portfolio, excluding Somatuline. This will be driven by IQIRVO, Bylvay, Dysport, but also Cabometyx, as well as a continued growth from Somatuline. Given the recent challenges with regard to the manufacturing and availability of generic lanreotide, we assume limited generic supply in 2026, with a potential entrance only in the second half of this year. On profitability now, we anticipate a core operating margin greater than 35% of total sales.
Speaker #3: For total sales, we expect growth of more than 13% at constant exchange rates. This year, we also anticipate adverse impact of around 2% from currency, based on the January exchange rate.
Speaker #3: This guidance on sales is assuming an accelerated sales growth of the portfolio, excluding something. This will be driven by IQURVO, Bill Vay, this port, but also Cabomatics.
Speaker #3: As well as the continued growth from something. Given the recent challenges with regard to the manufacturing and availability of generic Loreotide, we assume limited generic supply in 2026, with a potential entrant only in the second half of this year.
Speaker #3: On profitability now, we anticipate a core operating margin greater than 35% of total sales. We will continue to leverage our top line growth with moderate increase in SG&A and R&D ratio to stay around 20% of sales.
Aymeric Le Chatelier: We will continue to leverage our top-line growth with moderate increase in SG&A and R&D ratio to stay around 20% of sales. However, currency rate and a lower level of other revenue will have an adverse impact on our margin in 2026. Regarding our midterm outlook, we are highly confident to exceed our total sales average growth of at least 7% per year for the period 2023 to 2027, and our 2027 core operating margin greater than 32%... given the higher than expected Somatuline sales due to continued generic lanreotide challenges and the stronger performance of our broader portfolio across our three therapeutic areas. With that, I will now hand over to David. Please turn to slide 17.
Aymeric Le Chatelier: We will continue to leverage our top-line growth with moderate increase in SG&A and R&D ratio to stay around 20% of sales. However, currency rate and a lower level of other revenue will have an adverse impact on our margin in 2026. Regarding our midterm outlook, we are highly confident to exceed our total sales average growth of at least 7% per year for the period 2023 to 2027, and our 2027 core operating margin greater than 32%... given the higher than expected Somatuline sales due to continued generic lanreotide challenges and the stronger performance of our broader portfolio across our three therapeutic areas. With that, I will now hand over to David. Please turn to slide 17.
Speaker #3: However, currency rate and a lower level of other revenue will have an adverse impact on our margin in 2026. Regarding our mid-term outlook, we are highly confident to exceed our total sales average growth of at least 7% per year for the period 23 to 27, and our 2027 core operating margin greater than 32%, given the higher-than-expected something in sales due to the continued generic Loreotide challenges, and the stronger performance of our broader portfolio across our free therapeutic areas.
Speaker #3: With that, I will now hand over to David. Please turn to slide 17.
Speaker #2: Thank you, Aymeric. I will now provide an update on our R&D efforts. Please turn to slide 18. We have another exciting year for our pipeline.
David Loew: Thank you, Aymeric. I will now provide an update on our R&D efforts. Please turn to slide 18. We have another exciting year for our pipeline. We have seen strong expansion in Oncology, with 4 active phase 1 programs evaluating promising new modalities in solid tumors, and the addition of IPN6340, formerly known as ICT01, which came through the acquisition of ImCheck. In Rare Disease, following the positive phase 2 trial, we have opened a phase 3 program evaluating elafibranor in primary sclerosing cholangitis, which I will share more on in a moment. In Neuroscience, our broad programs continue to advance across both Dysport and our long-acting molecule, IPN10200, with new phase 3 programs expected to open in H1. Please turn to slide 19. In Oncology, a growing focus of our pipeline is on precisely modulating the immune system through multiple synergistic routes.
David Loew: Thank you, Aymeric. I will now provide an update on our R&D efforts. Please turn to slide 18. We have another exciting year for our pipeline. We have seen strong expansion in Oncology, with 4 active phase 1 programs evaluating promising new modalities in solid tumors, and the addition of IPN6340, formerly known as ICT01, which came through the acquisition of ImCheck. In Rare Disease, following the positive phase 2 trial, we have opened a phase 3 program evaluating elafibranor in primary sclerosing cholangitis, which I will share more on in a moment. In Neuroscience, our broad programs continue to advance across both Dysport and our long-acting molecule, IPN10200, with new phase 3 programs expected to open in H1. Please turn to slide 19. In Oncology, a growing focus of our pipeline is on precisely modulating the immune system through multiple synergistic routes.
Speaker #2: We have seen strong expansion in oncology, with four active Phase 1 programs evaluating promising new modalities in solid tumors, and the addition of IPN6340, formerly known as ICT01, which came through the acquisition of ImCheck.
Speaker #2: In rare disease, following the positive phase two trial, we have opened a phase three program evaluating Elafibranor in primary sclerosing cholangitis, which I will share more on in a moment.
Speaker #2: In neuroscience, our broad programs continue to advance across both this port and our long-acting molecule IPN 10-200, with new Phase 3 programs expected to open in H1.
Speaker #2: Please turn to slide 19. In oncology, a growing focus of our pipeline is on precisely modulating the immune system through multiple synergistic routes. I would like to highlight a couple of new molecules entering phase one.
David Loew: I would like to highlight a couple of new molecules entering phase I. Our antibody drug conjugates, IPN6300, targets a novel tumor antigen known to be expressed on multiple solid tumor types, and we are pleased to confirm first patients have been dosed in this trial. We also have our T-cell activator, IPN01203, a potential first-in-class asset that selectively activates Vβ6 T-cells through TCR and IL-15R pathways. Please turn to slide 20. Moving to rare disease and primary sclerosing cholangitis, or PSC, an area with no approved treatment options and the majority of patients requiring a liver transplant. Following the promising phase II data, we are excited to announce a phase III study, L-SCOPE, which will be the only global study in PSC looking at the long-term clinical outcomes as primary objective.
David Loew: I would like to highlight a couple of new molecules entering phase I. Our antibody drug conjugates, IPN6300, targets a novel tumor antigen known to be expressed on multiple solid tumor types, and we are pleased to confirm first patients have been dosed in this trial. We also have our T-cell activator, IPN01203, a potential first-in-class asset that selectively activates Vβ6 T-cells through TCR and IL-15R pathways. Please turn to slide 20. Moving to rare disease and primary sclerosing cholangitis, or PSC, an area with no approved treatment options and the majority of patients requiring a liver transplant. Following the promising phase II data, we are excited to announce a phase III study, L-SCOPE, which will be the only global study in PSC looking at the long-term clinical outcomes as primary objective.
Speaker #2: Our antibody-drug conjugate IPN 6300 targets a novel tumor antigen known to be expressed on multiple solid tumor types and we are pleased to confirm first patients have been dosed in this trial.
Speaker #2: We also have our T cell activator IPN01203, a potential first-in-class asset that selectively activates V beta 6 T cells through TCR and IL-15R pathways.
Speaker #2: Please turn to slide 20. Moving to rare disease and primary sclerosing cholangitis, or PSC, an area with no approved treatment options and the majority of patients requiring a liver transplant.
Speaker #2: Following the promising phase two data, we are excited to announce a phase three study, ELASCOPE, which will be the only global study in PSC looking at long-term clinical outcomes as the primary objective.
Speaker #2: ELASCOPE will evaluate the efficacy and safety of Elafibranor 120 milligrams versus placebo in patients with PSC, based on time to first occurrence of clinical outcome events and multiple secondary endpoints.
David Loew: L-SCOPE will evaluate the efficacy and safety of elafibranor 120 milligrams versus placebo in patients with PSC, based on time to first occurrence of clinical outcome events and multiple secondary endpoints. Please turn to slide 21. Turning to neuroscience, following the announcement of our phase 2 first proof of concept in glabellar lines in September 2025, we are on track to open two global phase 3 trials for IPN10200 in glabellar lines. Both trials will evaluate the efficacy and safety of IPN10200 at week 4 and 24, with key secondary endpoints, including patient satisfaction scores and onset of action. Please turn to slide 22. We remain diligent in our external innovation efforts and announced strong additions to the oncology pipeline as we close 2025.
David Loew: L-SCOPE will evaluate the efficacy and safety of elafibranor 120 milligrams versus placebo in patients with PSC, based on time to first occurrence of clinical outcome events and multiple secondary endpoints. Please turn to slide 21. Turning to neuroscience, following the announcement of our phase 2 first proof of concept in glabellar lines in September 2025, we are on track to open two global phase 3 trials for IPN10200 in glabellar lines. Both trials will evaluate the efficacy and safety of IPN10200 at week 4 and 24, with key secondary endpoints, including patient satisfaction scores and onset of action. Please turn to slide 22. We remain diligent in our external innovation efforts and announced strong additions to the oncology pipeline as we close 2025.
Speaker #2: Please turn to slide 21. Turning to neuroscience, following the announcement of our Phase 2 first proof of concept in global alliance in September 25, we are on track to open two global Phase 3 trials for IPN 10-200 in global alliance.
Speaker #2: Both trials will evaluate the efficacy and safety of IPN 10-200 at week 4 and week 24, with key secondary endpoints including patient satisfaction scores and onset of action.
Speaker #2: Please turn to slide 22. We remain diligent in our external innovation efforts and announced strong additions to the oncology pipeline as we close '25.
Speaker #2: We are delighted that the lead program IPN 6340 from our acquisition of ImCheck Therapeutics was awarded US FDA breakthrough therapy designation in January, recognizing investigational therapies with evidence of a substantial clinical improvement.
David Loew: We are delighted that the lead program, IPN6340, from our acquisition of ImCheck Therapeutics, was awarded US FDA Breakthrough Therapy Designation in January, recognizing investigational therapies with evidence of a substantial clinical improvement. A global licensing with Sincere Siming outside of Greater China brings another antibody drug conjugate into our pipeline, which is expected to enter phase I soon. Finally, reinforcing the strength of our ongoing partnership, we added further two research programs with Incyte, evaluating MAPK-related inhibition. Please turn to slide 23. As you can see, we have several milestones to look forward to over the coming years. Firstly, we await the EU regulatory decision for Tovorafenib in the first half.
David Loew: We are delighted that the lead program, IPN6340, from our acquisition of ImCheck Therapeutics, was awarded US FDA Breakthrough Therapy Designation in January, recognizing investigational therapies with evidence of a substantial clinical improvement. A global licensing with Sincere Siming outside of Greater China brings another antibody drug conjugate into our pipeline, which is expected to enter phase I soon. Finally, reinforcing the strength of our ongoing partnership, we added further two research programs with Incyte, evaluating MAPK-related inhibition. Please turn to slide 23. As you can see, we have several milestones to look forward to over the coming years. Firstly, we await the EU regulatory decision for Tovorafenib in the first half.
Speaker #2: A global licensing, with some serious signing outside of Greater China, brings another antibody-drug conjugate into our pipeline, which is expected to enter Phase 1 soon.
Speaker #2: Finally, reinforcing the strength of our ongoing partnership, we added a further two research programs with IRICOR evaluating MAPK-related inhibition. Please turn to slide 23.
Speaker #2: As you can see, we have several milestones to look forward to over the coming years. Firstly, we await the EU regulatory decision for toporafenib in the first half.
Speaker #2: In the second half, we see many phase three unblindings for Bilvei in biliary atresia, Icorbo for PBC patients with an ALP of between 1 and 1.67, and this port in migraine and also further phase two data for IPN 10-200 in forehead lines and lateral canthal lines.
David Loew: In the second half, we see many phase 3 unblindings for Bylvay in biliary atresia, IQIRVO for PBC patients with an ALP of between 1 and 1.67, and Dysport in migraine, and also further phase 2 data for IPN10200 in glabellar lines and lateral canthal lines. Then, as we look to next year, we have more proof of concept readouts for our long-acting neuromodulator, IPN10200, in the therapeutics indication, as well as phase 3 unblindings for Tazverik and tovorafenib. With that, please turn to slide 24. We continue on our strong momentum and remain firmly on track to achieve our ambitions. I'd like to leave you with two key messages. First, we delivered strong 25 results with double-digit sales and profit growth, fueled by the performance of our existing portfolio and launches.
David Loew: In the second half, we see many phase 3 unblindings for Bylvay in biliary atresia, IQIRVO for PBC patients with an ALP of between 1 and 1.67, and Dysport in migraine, and also further phase 2 data for IPN10200 in glabellar lines and lateral canthal lines. Then, as we look to next year, we have more proof of concept readouts for our long-acting neuromodulator, IPN10200, in the therapeutics indication, as well as phase 3 unblindings for Tazverik and tovorafenib. With that, please turn to slide 24. We continue on our strong momentum and remain firmly on track to achieve our ambitions. I'd like to leave you with two key messages. First, we delivered strong 25 results with double-digit sales and profit growth, fueled by the performance of our existing portfolio and launches.
Speaker #2: Then, as we look to next year, we have more proof-of-concept readouts for our long-acting neuromodulator IPN 10-200 in the therapeutics indication, as well as phase three unblindings for cesarean and toporafenib.
Speaker #2: With that, please turn to slide 24. We continue on our strong momentum and remain firmly on track to achieve our ambitions. I'd like to leave you with two key messages.
Speaker #2: First, we delivered strong 25 results with double-digit sales and profit growth fueled by the performance of our existing portfolio and launches. This consistent growth reflects our focus on execution and our ability to deliver across both commercial and medical fronts.
David Loew: This consistent growth reflects our focus on execution and our ability to deliver across both commercial and medical fronts. We will further strengthen our R&D investments and grow our internal pipeline while investing to support our current and future commercial launches. Secondly, the outlook to 2026 is strong, with double-digit sales growth guidance, multiple regulatory and clinical milestones to come, and significant firepower to pursue external innovation. We look forward to another year of accelerated growth as we continue on our transformation. Turn to slide 25. This concludes our presentation, and we will now take your questions. Operator, over to you.
David Loew: This consistent growth reflects our focus on execution and our ability to deliver across both commercial and medical fronts. We will further strengthen our R&D investments and grow our internal pipeline while investing to support our current and future commercial launches. Secondly, the outlook to 2026 is strong, with double-digit sales growth guidance, multiple regulatory and clinical milestones to come, and significant firepower to pursue external innovation. We look forward to another year of accelerated growth as we continue on our transformation. Turn to slide 25. This concludes our presentation, and we will now take your questions. Operator, over to you.
Speaker #2: We will further strengthen our R&D investments and grow our internal pipeline while investing to support our current and future commercial launches. Secondly, the outlook to 2026 is strong with double-digit sales growth guidance, multiple regulatory and clinical milestones to come, and significant firepower to pursue external innovation.
Speaker #2: We look forward to another year of accelerated growth as we continue on our transformation. Turn to slide 25. This concludes our presentation and we will now take your questions.
Speaker #2: Operator, over to you.
Speaker #1: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again.
Operator: ... Thank you. As a reminder, to ask a question, please press star one, one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take our first question from the line of Charles Pitman King from Barclays. Please go ahead.
Operator: ... Thank you. As a reminder, to ask a question, please press star one, one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take our first question from the line of Charles Pitman King from Barclays. Please go ahead.
Speaker #1: We will now take our first question. From the line of Charles Pitman King from Barclays, please go ahead.
[Analyst] (Barclays): Hi, guys, Charles Pitman King from Barclays. Two questions from me, please. Firstly, just on your guidance, I think it's quite noteworthy that, you know, your guidance in FY 2026 is significantly ahead of that midterm growth outlook. So firstly, just is it fair to say your guidance philosophy is less conservative this year? And given the double-digit growth in FY 2025 and guided for 2026, just wondering kind of why you're not looking to readdress and raise that midterm target into 2027. Then just secondly, on the kind of aesthetics and neurotoxin business, can you just confirm, in press release, you talk about product mix dynamics seen in the US, given this is a single product, I'm just wondering kind of what these are, if you could provide a little more clarity.
Charles Pitman: Hi, guys, Charles Pitman King from Barclays. Two questions from me, please. Firstly, just on your guidance, I think it's quite noteworthy that, you know, your guidance in FY 2026 is significantly ahead of that midterm growth outlook. So firstly, just is it fair to say your guidance philosophy is less conservative this year? And given the double-digit growth in FY 2025 and guided for 2026, just wondering kind of why you're not looking to readdress and raise that midterm target into 2027. Then just secondly, on the kind of aesthetics and neurotoxin business, can you just confirm, in press release, you talk about product mix dynamics seen in the US, given this is a single product, I'm just wondering kind of what these are, if you could provide a little more clarity.
Speaker #3: Hi guys, Charles Pitman King from Barclays, two questions from me, please. Firstly, just on your guidance, I think it's quite noteworthy that your guidance in FY26 is significantly ahead of that mid-term growth outlook.
Speaker #3: So, firstly, just—is it fair to say your guidance philosophy is less conservative this year? And, given the double-digit growth in FY25 and guided for '26, just wondering kind of why you're not looking to readdress and raise that mid-term target into '27.
Speaker #3: Then just secondly, on the kind of aesthetics neurotox business, can you just confirm—in the press release you talk about product mix dynamics seen in the US—given this is a single product?
Speaker #3: I'm just wondering kind of what these are, if you could provide a little bit more clarity. And then just beyond that, I know you're unlikely to comment, but just if you're able to give us any further thoughts on the potential partnership discussions you're having with IPSEN 10-200 within the aesthetics indication, that would be great.
[Analyst] (Barclays): And then just beyond that, I know you're unlikely to comment, but just if you're able to give us any further thoughts on the potential partnership discussions you're having with Ipsen IPN10200 within the aesthetics indication, that would be great. Thank you.
Charles Pitman: And then just beyond that, I know you're unlikely to comment, but just if you're able to give us any further thoughts on the potential partnership discussions you're having with Ipsen IPN10200 within the aesthetics indication, that would be great. Thank you.
Speaker #3: Thank you.
Speaker #4: Okay, thank you, Charles. I will let Aymeric answer on your guidance question.
David Loew: Okay. Thank you, Charles. I will let Aymeric answer on your guidance question.
David Loew: Okay. Thank you, Charles. I will let Aymeric answer on your guidance question.
Aymeric Le Chatelier: Yes. So, thanks for the questions, and maybe I will clarify. I think that our guidance today is our best estimates regarding first Somatuline on one side, for which we are still expecting potentially some generics to be able to be on the market in the second half of the year. So I will say, we are pretty balanced, and I think we have also a great ambition to continue a very strong growth of the portfolio, ex Somatuline, where we expect to be able to accelerate the growth, and we deliver 14% growth this year. Regarding the midterm target, as you remember, the midterm target was to exceed 7% annual growth and to exceed 32% margin by 2027.
Aymeric Le Chatelier: Yes. So, thanks for the questions, and maybe I will clarify. I think that our guidance today is our best estimates regarding first Somatuline on one side, for which we are still expecting potentially some generics to be able to be on the market in the second half of the year. So I will say, we are pretty balanced, and I think we have also a great ambition to continue a very strong growth of the portfolio, ex Somatuline, where we expect to be able to accelerate the growth, and we deliver 14% growth this year. Regarding the midterm target, as you remember, the midterm target was to exceed 7% annual growth and to exceed 32% margin by 2027.
Speaker #5: And maybe I will clarify. I think that our guidance is today our best estimates regarding first, Somatuline on one side, for which we are still expecting potentially some generic to be able to be on the market in the second half of the year.
Speaker #5: So I will say we are pretty balanced and I think we have also a great ambition to continue a very strong growth of the portfolio ex somatoline where we expect to be able to accelerate the growth and we deliver 14% growth this year.
Speaker #5: Regarding the mid-term target, as you remember, the mid-term target was to exceed 7% annual growth and to exceed a 32% margin by 2027. So I think the message today is very clear that we are highly confident we're going to do better than those numbers, but this is still going to be exceeding, and I don't think we want to provide two guidances for two consequential years.
Aymeric Le Chatelier: So, I think the message today is very clear that we are highly confident we're gonna do better than this number, but this is still gonna be exceeding, and I don't think we want to provide too much guidance for two consecutive years. So, we are clearly highly confident in 2027 and will provide a guidance for 2027 when it's gonna be time in a year's time.
Aymeric Le Chatelier: So, I think the message today is very clear that we are highly confident we're gonna do better than this number, but this is still gonna be exceeding, and I don't think we want to provide too much guidance for two consecutive years. So, we are clearly highly confident in 2027 and will provide a guidance for 2027 when it's gonna be time in a year's time.
Speaker #5: So we are clearly highly confident to 2027, and we'll provide guidance for 2027 when it's going to be time, in due time. And the product mix—maybe I can just answer the product mix and let you answer.
David Loew: On the-
David Loew: On the-
Aymeric Le Chatelier: Product mix, maybe. Yeah, I can just answer the product mix and let you answer. So I think the product mix is more related to the product and sample of Dysport in aesthetics. As you know, we're providing our partner with both product and sample, and the economics are slightly different. That explains what we qualify as a product mix in our communication.
Aymeric Le Chatelier: Product mix, maybe. Yeah, I can just answer the product mix and let you answer. So I think the product mix is more related to the product and sample of Dysport in aesthetics. As you know, we're providing our partner with both product and sample, and the economics are slightly different. That explains what we qualify as a product mix in our communication.
Speaker #5: So I think the product mix is more related to the product and sample of this port in aesthetic. As you know, we're providing our partner with both product and sample and the economics are slightly different.
Speaker #5: That explains what we qualified as a product miss in our communication.
Speaker #4: Then on your third question, on our long-acting neurotoxin, as you know, in January 26, the arbitral tribunal of the International Chamber of Commerce issued a final decision in favor of IPSEN.
David Loew: Then on your third question, you know, on our long-acting neurotoxin. As you know, in January 2026, the Arbitral Tribunal of the International Chamber of Commerce issued a final decision in favor of Ipsen, dismissing the claims brought by Galderma in connection with Ipsen's termination of the R&D agreement. And so, the tribunal confirmed also Ipsen's full rights to its clinical stage toxin programs in the aesthetics field, including therefore the IPN10200 that you were alluding to. So basically, we continue to assess all options, and we can't give you more information at this point, but we're gonna come back as soon as, you know, we have made progress on this. Next question, please.
David Loew: Then on your third question, you know, on our long-acting neurotoxin. As you know, in January 2026, the Arbitral Tribunal of the International Chamber of Commerce issued a final decision in favor of Ipsen, dismissing the claims brought by Galderma in connection with Ipsen's termination of the R&D agreement. And so, the tribunal confirmed also Ipsen's full rights to its clinical stage toxin programs in the aesthetics field, including therefore the IPN10200 that you were alluding to. So basically, we continue to assess all options, and we can't give you more information at this point, but we're gonna come back as soon as, you know, we have made progress on this. Next question, please.
Speaker #4: Dismissing the claims brought by Galderma in connection with IPSEN's termination of the R&D agreement. And so the tribunal confirmed also IPSEN's full rights to its clinical stage toxin programs in the aesthetics field, including therefore the IPN 10-200 that you were alluding to.
Speaker #4: So basically, we continue to assess all options and we can't give you more information at this point, but we're going to come back as soon as we have made progress on this.
Speaker #4: Next question, please.
Speaker #3: Thank you very much.
Aymeric Le Chatelier: Thank you very much.
Aymeric Le Chatelier: Thank you very much.
Speaker #1: Thank you. We will now take the next question. From the line of Xiang Deng from UBS, please go ahead.
Operator: Thank you. We will now take the next question from the line of Xian Dang from UBS. Please go ahead.
Operator: Thank you. We will now take the next question from the line of Xian Dang from UBS. Please go ahead.
[Analyst] (Barclays): Hi. Thank you very much. It's Xian from UBS. Two questions, please. So, both on IQIRVO. Just wondering, the first question, sorry, the first question is just wondering, you know, IQIRVO previously, you know, you guided for EUR 500 million peak sales. And, but of course, now the drug is doing really, really well. So I was just wondering, you know, would you say now your peak sales guidance there is very conservative? And, you know, if you could maybe give us some colors on what assumptions did you have when you set the guidance and what has changed since then? So that's the first question. And the second one is also on IQIRVO. Actually, just wondering about the patent or exclusivity situation.
Xian Deng: Hi. Thank you very much. It's Xian from UBS. Two questions, please. So, both on IQIRVO. Just wondering, the first question, sorry, the first question is just wondering, you know, IQIRVO previously, you know, you guided for EUR 500 million peak sales. And, but of course, now the drug is doing really, really well. So I was just wondering, you know, would you say now your peak sales guidance there is very conservative? And, you know, if you could maybe give us some colors on what assumptions did you have when you set the guidance and what has changed since then? So that's the first question. And the second one is also on IQIRVO. Actually, just wondering about the patent or exclusivity situation.
Speaker #6: Hi, thank you very much. It's Xiang from UBS. Two questions, please. So I bought an alcohol. So just wondering the first question, sorry, the first question is just wondering alcohol previously you guided for 500 million peak sales.
Speaker #6: But of course, now the drug is doing really, really well. So I was just wondering, would you say now your peak sale guidance there is very conservative?
Speaker #6: And if you could maybe give us some colors on what assumptions did you have when you set the guidance and what has changed since then?
Speaker #6: So that's the first question. And the second one is also on alcohol. Actually, just wondering about the patent or exclusivity situation. So, my understanding is that the compound patent has already expired in the US.
[Analyst] (Barclays): So, my understanding is that the compound patent has already expired in the US, right now is protected by also exclusivity on PBC. So just wondering, given now you are also running and you already started the phase three in PSC, so just wondering, how should we think about the exclusivity, you know, patent protection on this one, please? Oh, sorry, just, can I just quickly clarify? Then, when you, did you, did I hear that right? You mentioned also that you are expecting potential generics to come back in second half this year. So is that conservative as well? Have I heard that right? Thank you.
Xian Deng: So, my understanding is that the compound patent has already expired in the US, right now is protected by also exclusivity on PBC. So just wondering, given now you are also running and you already started the phase three in PSC, so just wondering, how should we think about the exclusivity, you know, patent protection on this one, please? Oh, sorry, just, can I just quickly clarify? Then, when you, did you, did I hear that right? You mentioned also that you are expecting potential generics to come back in second half this year. So is that conservative as well? Have I heard that right? Thank you.
Speaker #6: Right now it's protected by often exclusivity on PVC. So just wondering, given now you are also running you already started the phase three in PSC.
Speaker #6: So just wondering how should we think about the exclusivity/patent protection on this one, please? Oh, sorry, just can I just quickly clarify? When you did I hear that right?
Speaker #6: You mentioned on Somatuline, you are expecting potential generics to come back in the second half of this year. So, is that conservative as well?
Speaker #6: Have I heard that right? Thank you.
Speaker #3: Okay. Thank you, Xiang. So, on alcohol, the $500 million peak sales guidance — so, yeah, we are very pleased with the performance, I have to say.
David Loew: Thank you, Xian. On IQIRVO, the $500 million peak sales guidance, we are very pleased with the performance, I have to say. We are going to observe how this goes, especially as we have the Elspire trial, which is going to read out in the middle of this year. Subsequently, once we have seen that, we are going to look at potentially changing the guidance if required. For now, we say it is above $500 million, but I have to say, we are extremely pleased with what we are seeing and with the performance that we have in the US and ex US. On your exclusivity question, we have orphan drug protection until 2031. There are additional patents which exist as well.
David Loew: Thank you, Xian. On IQIRVO, the $500 million peak sales guidance, we are very pleased with the performance, I have to say. We are going to observe how this goes, especially as we have the Elspire trial, which is going to read out in the middle of this year. Subsequently, once we have seen that, we are going to look at potentially changing the guidance if required. For now, we say it is above $500 million, but I have to say, we are extremely pleased with what we are seeing and with the performance that we have in the US and ex US. On your exclusivity question, we have orphan drug protection until 2031. There are additional patents which exist as well.
Speaker #3: We are going to observe how this goes. And especially, also, we have the L-SPIRE trial, which is going to read out in the middle of this year.
Speaker #3: And then subsequently once we have seen that, we're going to look at potentially looking at changing the guidance if required. For now, we say it's above 500 million.
Speaker #3: But I have to say we're extremely pleased with what we are seeing, and with the performance that we have in the US and ex-US.
Speaker #3: Yeah. On your on the exclusivity question, we have often drug protection until '31. There are additional patents which exist as well. Just to help you also on PSC, on that question, because the PSC, and I think you're alluding to this, might report shortly before that date of the '31 that you have given.
David Loew: Just to help you also on PSC, on that question, because. And I think you're alluding to this might report, you know, shortly before that date of the 31 that you have given. You need to keep in mind that first, we have gotten orphan drug designation for PSC, so there is a separate protection for PSC. It's a different dose. It's 120mg, not 80mg, so that's already very different. There will be a different tablet as well. It's a different packaging, et cetera. So, we think this is gonna confer quite a good protection, and this is why we have given a go to that trial, besides being excited about the data, obviously.
David Loew: Just to help you also on PSC, on that question, because. And I think you're alluding to this might report, you know, shortly before that date of the 31 that you have given. You need to keep in mind that first, we have gotten orphan drug designation for PSC, so there is a separate protection for PSC. It's a different dose. It's 120mg, not 80mg, so that's already very different. There will be a different tablet as well. It's a different packaging, et cetera. So, we think this is gonna confer quite a good protection, and this is why we have given a go to that trial, besides being excited about the data, obviously.
Speaker #3: You need to keep in mind that, first, we have gotten orphan drug designation for PSC. So there is a separate protection for PSC. It's a different dose.
Speaker #3: It's 120 milligrams, not 80. So that's already very different. There will be a different tablet as well. It's a different packaging, etc. So we think this is going to confer quite a good protection.
Speaker #3: And this is why we have given a go to that trial, besides being excited about the data, obviously. And then, on your third question regarding Somatuline, H2, it's hard always to exactly know what's happening with these generic companies.
David Loew: And then on your third question regarding Somatuline, you know, H2, it's hard always to exactly know what's happening with these generic companies. What I can say is, and we have said that in the past, and I think it becomes very obvious, it's a very difficult product to produce because the gel is very viscous. It shouldn't be too viscous, it shouldn't be too liquid. So it's hard to produce. You have also seen that there have been FDA 483s and OAIs on some of our competitors. So I think for the moment, it is reasonable to say that we're anticipating generics, you know, entering in H2. Thank you. Next question.
David Loew: And then on your third question regarding Somatuline, you know, H2, it's hard always to exactly know what's happening with these generic companies. What I can say is, and we have said that in the past, and I think it becomes very obvious, it's a very difficult product to produce because the gel is very viscous. It shouldn't be too viscous, it shouldn't be too liquid. So it's hard to produce. You have also seen that there have been FDA 483s and OAIs on some of our competitors. So I think for the moment, it is reasonable to say that we're anticipating generics, you know, entering in H2. Thank you. Next question.
Speaker #3: What I can say is, and we have said that in the past—and I think it becomes very obvious—it’s a very difficult product to produce because the gel is very viscous.
Speaker #3: It shouldn't be too viscous. It shouldn't be too liquid. So it's hard to produce you have also seen that there have been FDA 483s and OAIs on some of our competitors.
Speaker #3: So I think for the moment it is reasonable to say that we're anticipating generics entering in H2. Thank you. Next question.
Speaker #1: Thank you. We will now take the next question. From the line of Simone Baker from Rothschild & Co in Redburn, please go ahead.
Operator: Thank you. We will now take the next question from the line of Simon Baker from Rothschild & Co, Redburn. Please go ahead.
Operator: Thank you. We will now take the next question from the line of Simon Baker from Rothschild & Co, Redburn. Please go ahead.
Speaker #4: Thank you for taking my questions. Three, if I may, please. Just going back to somatoline, you've indicated the at best there will be some generics later in this year.
Simon Baker: Thank you for taking my questions. Three, if I may, please. Just going back to Somatuline. You've indicated that at best, there will be some generics later in this year. But I'm looking at this from a slightly different perspective. Where does this leave you in terms of long-term contracting with your customers? Because it's all fine and dandy to have a generic available at a significant discount, but if the manufacturer can't deliver and can't manufacture it, it's rather academic for the customer and creates a lot of inconvenience. So does this really open up the possibility for tying in your customers into long-term contracting, where you alone in the market can guarantee quality and supply? Any thoughts on that would be very helpful.
Simon Baker: Thank you for taking my questions. Three, if I may, please. Just going back to Somatuline. You've indicated that at best, there will be some generics later in this year. But I'm looking at this from a slightly different perspective. Where does this leave you in terms of long-term contracting with your customers? Because it's all fine and dandy to have a generic available at a significant discount, but if the manufacturer can't deliver and can't manufacture it, it's rather academic for the customer and creates a lot of inconvenience. So does this really open up the possibility for tying in your customers into long-term contracting, where you alone in the market can guarantee quality and supply? Any thoughts on that would be very helpful.
Speaker #4: But looking at this from a slightly different perspective, where does this leave you in terms of long-term contracting with your customers? Because it's all fine and dandy to have a generic available at a significant discount.
Speaker #4: But if the manufacturer can't deliver and can't manufacture it, it's rather academic for the customer. And creates a lot of inconvenience. So does this really open up the possibility for tying in your customers through long-term contracting where you alone in the market can guarantee quality and supply?
Speaker #4: Any thoughts on that would be very helpful. And then, just a couple of quick ones. You gave us the patient incidence of PSC in the States.
Simon Baker: And then just a couple of quick ones. You gave us the patient incidence of PSC in the States. I just wonder if you could give us a little bit more detail on, on, and pointers on how big you think this opportunity is. Some have suggested this is a billion-dollar opportunity, and as you say, there are no existing treatments, so any thoughts there would be helpful. And then finally, on Onivyde, if you could just give us an update on the sort of commercial dynamic share of voice in that category, because your competitor there is rather preoccupied with launching another product in another category. I just wanted to see if there's been any change to marketing intensity by competitors in that space. Thanks so much.
Simon Baker: And then just a couple of quick ones. You gave us the patient incidence of PSC in the States. I just wonder if you could give us a little bit more detail on, on, and pointers on how big you think this opportunity is. Some have suggested this is a billion-dollar opportunity, and as you say, there are no existing treatments, so any thoughts there would be helpful. And then finally, on Onivyde, if you could just give us an update on the sort of commercial dynamic share of voice in that category, because your competitor there is rather preoccupied with launching another product in another category. I just wanted to see if there's been any change to marketing intensity by competitors in that space. Thanks so much.
Speaker #4: I just wondered if you could give us a little bit more detail on pointers on how big you think this opportunity is. Some have suggested this is a billion-dollar opportunity.
Speaker #4: And as you say, there are no existing treatments, so any thoughts there would be helpful. And then finally, on our Cervo, if you could just give us an update on the sort of commercial dynamics, share of voice in that category.
Speaker #4: Because your competitor there is rather preoccupied with launching another product in another category. I just wanted to see if there's been any change to marketing intensity by competitors in that space.
Speaker #4: Thanks so much.
Speaker #3: Thank you, Simon. On Somatoline, we, of course, do contracting with several of the customers, especially in the US, of course. That's a current practice, I would say.
David Loew: Thank you, Simon. On Somatuline, you know, we, of course, do contracting with several of the customers, especially in the US. Of course, that's a current practice, I would say. And this has, in the past, already helped, you know, to mitigate somewhat the penetration of the generics. So I would say we have done this already before, and you have seen the effect of it. So it all comes down, I would say, can they actually deliver or not, and in what kind of quantities? On your second question, to give you a feeling on PSC, PSC is about the same market opportunity as PBC. And why do I say this? In PBC, it's a second-line indication that we and Gilead are having currently.
David Loew: Thank you, Simon. On Somatuline, you know, we, of course, do contracting with several of the customers, especially in the US. Of course, that's a current practice, I would say. And this has, in the past, already helped, you know, to mitigate somewhat the penetration of the generics. So I would say we have done this already before, and you have seen the effect of it. So it all comes down, I would say, can they actually deliver or not, and in what kind of quantities? On your second question, to give you a feeling on PSC, PSC is about the same market opportunity as PBC. And why do I say this? In PBC, it's a second-line indication that we and Gilead are having currently.
Speaker #3: And this has in the past already helped to mitigate somewhat the penetration of the generics. So I would say we have done this already before.
Speaker #3: And you have seen the effect of it. So it all comes down, I would say, can they actually deliver or not? And in what kind of quantities?
Speaker #3: On your second question, to give you a feeling on PSC, PSC is about the same market opportunity as PBC. And why do I say this?
Speaker #3: In PBC, it's a second-line indication that we and Gilead are having currently. And so we're talking roughly 30,000 patients in the above 1.67 at about 20,000 in the below 1.67.
David Loew: And so we're talking roughly, you know, 30,000 patients in the above 1.67, and about 20,000 in the below 1.67. And then in PSC, you have 40,000 patients, prevalent patients, huh? And so that means that today, all these prevalent patients, they have no solution in PSC, and we're actually gonna be first line, contrary to PBC, where we are second line. So basically, that explains why the market opportunity is about equal as the whole PBC pool. So for us, quite an exciting opportunity, I would say. And then on your third question, the dynamic share of voice. So for the moment, we don't see a change on Gilead's presence. They are heavily present, I would say, so as we are, right?
David Loew: And so we're talking roughly, you know, 30,000 patients in the above 1.67, and about 20,000 in the below 1.67. And then in PSC, you have 40,000 patients, prevalent patients, huh? And so that means that today, all these prevalent patients, they have no solution in PSC, and we're actually gonna be first line, contrary to PBC, where we are second line. So basically, that explains why the market opportunity is about equal as the whole PBC pool. So for us, quite an exciting opportunity, I would say. And then on your third question, the dynamic share of voice. So for the moment, we don't see a change on Gilead's presence. They are heavily present, I would say, so as we are, right?
Speaker #3: And then in PSC, you have 40,000 patients prevalent patients. And so that means that today all these prevalent patients, they have no solution in PSC.
Speaker #3: And we're actually going to be first-line contrary to PBC where we are second-line. So basically that explains why the market opportunity is about equal as the whole PBC pool.
Speaker #3: So for us, quite an exciting opportunity, I would say. And then on your third question, the dynamic share of voice. So for the moment, we don't see a change on Gilead's presence.
Speaker #3: There are heavily present, I would say. So as we are, right? So I think we perform very well. And we are very pleased with the performance that we are seeing.
David Loew: So, I think we perform very well, and we are very pleased with the performance that we are seeing. Thanks, Simon.
David Loew: So, I think we perform very well, and we are very pleased with the performance that we are seeing. Thanks, Simon.
Speaker #3: Thank you.
Simon Baker: Thanks so much.
Simon Baker: Thanks so much.
Speaker #4: Thanks so much.
Speaker #1: Thank you. We will now take the next question. From the line of Richard Vosser from JPMorgan, please go ahead.
Operator: Thank you. We will now take the next question from the line of Richard Vosser from JP Morgan. Please go ahead.
Operator: Thank you. We will now take the next question from the line of Richard Vosser from JP Morgan. Please go ahead.
Speaker #4: Thanks for taking my questions. A few, please. Just returning to somatoline, I wonder if you could just talk about price and volume thoughts in '26.
Richard Vosser: Thanks for taking my questions. A few, please. Just returning to Somatuline. I wonder if you could just talk about price and volume thoughts in 2026. Clearly, lack of generics means potentially you could raise price. So if you could talk about that and how that might impact also on 2027. And for 2027 on Somatuline, you talked about, you know, the exceeding the margins. Just any thoughts of the extent of generic competition of Somatuline you might be thinking in 2027 would also be helpful. Second question, just on Onivyde as well. Just thinking about the growth, which has been stellar, what bolus-...
Richard Vosser: Thanks for taking my questions. A few, please. Just returning to Somatuline. I wonder if you could just talk about price and volume thoughts in 2026. Clearly, lack of generics means potentially you could raise price. So if you could talk about that and how that might impact also on 2027. And for 2027 on Somatuline, you talked about, you know, the exceeding the margins. Just any thoughts of the extent of generic competition of Somatuline you might be thinking in 2027 would also be helpful. Second question, just on Onivyde as well. Just thinking about the growth, which has been stellar, what bolus-...
Speaker #4: Clearly, lack of generics means, potentially, you could raise price. So if you could talk about that, and how that might impact also on '27.
Speaker #4: And for '27 on somatoline, you talked about exceeding the margins. Just any thoughts of the extent of generic competition of somatoline you might be thinking in '27 would also be helpful.
Speaker #4: Second question, just on Cervo as well. Just thinking about the growth, which has been stellar, what bolus do you think you've got from Ocaliva and how that might feed into growth expectations for the second half of '26?
Richard Vosser: Do you think you've got from Ocaliva and how that might feed into growth expectations for the second half of 2026? And then finally, on business development M&A, you know, you've highlighted the EUR 3.2 billion firepower. And I think previously you've highlighted, you know, thinking about strengthening the oncology business, but maybe you could give us an idea of latest thoughts around business development and what you're looking for, and how that might impact R&D spend going forward. Thanks very much.
Richard Vosser: Do you think you've got from Ocaliva and how that might feed into growth expectations for the second half of 2026? And then finally, on business development M&A, you know, you've highlighted the EUR 3.2 billion firepower. And I think previously you've highlighted, you know, thinking about strengthening the oncology business, but maybe you could give us an idea of latest thoughts around business development and what you're looking for, and how that might impact R&D spend going forward. Thanks very much.
Speaker #4: And then finally, on business development, M&A, you've highlighted the $3.2 billion firepower. And I think previously you've highlighted thinking about strengthening the oncology business.
Speaker #4: But maybe you could give us an idea of the latest thoughts around business development and what you're looking for, and how that might impact R&D spend going forward.
Speaker #4: Thanks very much.
Speaker #3: Yeah. Thank you, Richard. So on somatoline price volume, I'll let Aymeric answer. Yeah. So Richard, on somatoline, I'm not going to be able to provide you all the detail of our assumption.
David Loew: Yeah. Thank you, Richard. So on to volume, I'll let Aymeric answer.
David Loew: Yeah. Thank you, Richard. So on to volume, I'll let Aymeric answer.
Aymeric Le Chatelier: Yeah. So, Richard, on Somatuline, I'm gonna-- I'm not gonna be able to provide you all the detail of our assumption, but clearly, the lack of competition will allow you to-- will allow us to regain volume both in Europe and in the US. I think that's the trend on top of a very dynamic market that we see for NET, where it's still a market that is growing in the 4 to 5% per year, with very strong position for lanreotide. On the price side, I think there are opportunities, probably more in the US, and David was talking about on the prior questions regarding the contracting. As you know, there are significant rebates which have been negotiating in the US.
Aymeric Le Chatelier: Yeah. So, Richard, on Somatuline, I'm gonna-- I'm not gonna be able to provide you all the detail of our assumption, but clearly, the lack of competition will allow you to-- will allow us to regain volume both in Europe and in the US. I think that's the trend on top of a very dynamic market that we see for NET, where it's still a market that is growing in the 4 to 5% per year, with very strong position for lanreotide. On the price side, I think there are opportunities, probably more in the US, and David was talking about on the prior questions regarding the contracting. As you know, there are significant rebates which have been negotiating in the US.
Speaker #3: But clearly, the lack of competition will allow us to regain volume, both in Europe and in the US. I think that's the trend.
Speaker #3: On top of a very dynamic market that we'll see for NET, where it's still a market that is going in the four to five percent per year.
Speaker #3: With a very strong position for a longer time. On the price side, I think there are opportunities probably more in the US, and David was talking about it on the prior questions regarding the contracting.
Speaker #3: As you know, there is significant rebates which have been negotiating in the US. We have also passed a price increase at the beginning of the year.
Aymeric Le Chatelier: We have also passed a price increase at the beginning of the year. Ex-US, I will say the situation is more complicated. In many countries, it's quite difficult to change the pricing, and there may be some markets where we have tenders, and we are still assessing that opportunity. The second part of your question was regarding the margin in 2027. So as I said, I'm not gonna provide a guidance for 2027. As you know, we are very confident to exceed the outlook. Now, the shape of 2027 will depend at what pace the generic are gonna be able to make it, how many generic are gonna be able to make it, if any, in the second half of this year and in 2027, and that could have an impact on the level of profitability.
Aymeric Le Chatelier: We have also passed a price increase at the beginning of the year. Ex-US, I will say the situation is more complicated. In many countries, it's quite difficult to change the pricing, and there may be some markets where we have tenders, and we are still assessing that opportunity. The second part of your question was regarding the margin in 2027. So as I said, I'm not gonna provide a guidance for 2027. As you know, we are very confident to exceed the outlook. Now, the shape of 2027 will depend at what pace the generic are gonna be able to make it, how many generic are gonna be able to make it, if any, in the second half of this year and in 2027, and that could have an impact on the level of profitability.
Speaker #3: Ex-US, I will say the situation is more complicated in many countries. It's probably difficult to change the pricing. And there may be some markets where we have tenders and we are still assessing that opportunity.
Speaker #3: The second part of your question was regarding the margin in 2027. So as I said, I'm not going to provide a guidance for 2027.
Speaker #3: As you know, we are very confident to exceed the outlook. Now, the shape of 2027 will depend on what pace the generics are going to be able to make it, how many generics are going to be able to make it, if any, in the second half of this year and in 2027.
Speaker #3: And that could have an impact on the level of profitability. But we are very confident that, in any case, we will be exceeding, to some extent, the 32% target that we gave.
Aymeric Le Chatelier: But we are very confident that in any case, we will be exceeding to some extent the 32% target that we gave.
Aymeric Le Chatelier: But we are very confident that in any case, we will be exceeding to some extent the 32% target that we gave.
David Loew: Then on your third question regarding IQIRVO growth and the bolus of Ocaliva. So, what you have seen in terms of sales acceleration from September to December is, really that delta in terms of the acceleration came from the Ocaliva switches. We think the Ocaliva switches are mostly done. So, we are on a higher level, and that higher level should carry forward, of course, into 2026. Because we are seeing still, new patients, which are new to second line, coming, onto IQIRVO. So we're very pleased with that, and, this is why we are very confident on IQIRVO, and we observe a very strong dynamic. On mergers and acquisitions, so as you pointed out, we have, a bit more than EUR 3.2 billion of firepower.
David Loew: Then on your third question regarding IQIRVO growth and the bolus of Ocaliva. So, what you have seen in terms of sales acceleration from September to December is, really that delta in terms of the acceleration came from the Ocaliva switches. We think the Ocaliva switches are mostly done. So, we are on a higher level, and that higher level should carry forward, of course, into 2026. Because we are seeing still, new patients, which are new to second line, coming, onto IQIRVO. So we're very pleased with that, and, this is why we are very confident on IQIRVO, and we observe a very strong dynamic. On mergers and acquisitions, so as you pointed out, we have, a bit more than EUR 3.2 billion of firepower.
Speaker #4: Then, on your third question regarding Cervo growth and the bolus of Ocaliva—what you’ve seen in terms of sales acceleration from September to December is really that delta; in terms of the acceleration, it came from the Ocaliva switches.
Speaker #4: We think the Ocaliva switches are mostly done, so we are on a higher level. And that higher level should carry forward, of course, into 2026.
Speaker #4: Because we are seeing still new patients which are new to second-line coming onto Cervo. So we're very pleased with that. And this is why we are very confident on Cervo.
Speaker #4: And we observe a very strong dynamic. On mergers and acquisitions, so as you pointed out, we have a bit more than 3.2 billion of firepower.
David Loew: We intend to use this if we see the right opportunities. As I stated before at JP Morgan, we are looking at oncology late stage opportunities that we wanna bring on board. And then, of course, in our guidance, as you remember, we already include the preclinical and early clinical in that guidance and in the margin. So you will also see us use part of this firepower for some of the earlier deals. Thank you, operator. Next question.
David Loew: We intend to use this if we see the right opportunities. As I stated before at JP Morgan, we are looking at oncology late stage opportunities that we wanna bring on board. And then, of course, in our guidance, as you remember, we already include the preclinical and early clinical in that guidance and in the margin. So you will also see us use part of this firepower for some of the earlier deals. Thank you, operator. Next question.
Speaker #4: We intend to use this if we see the right opportunities. As I stated before, at JPMorgan, we are looking at oncology, late-stage opportunities that we want to bring on board.
Speaker #4: And then, of course, in our guidance, as you remember, we already include the preclinical and early clinical in that guidance and in the margin.
Speaker #4: So you will also see us use part of this firepower for some of the earlier deals. Thank you, operator. Next question.
Speaker #1: We will now take the next question. From the line of Victor Float from BNP Paribas, please go ahead.
Richard Vosser: We will now take the next question from the line of Victor Flot from BNP Paribas. Please go ahead.
Operator: We will now take the next question from the line of Victor Flot from BNP Paribas. Please go ahead.
Speaker #5: Thanks so much for taking my question, Director of BNP Paribas. A couple of questions on IPSEN Q2. So I mean, I think it's fair to say that the optimal target profile for that one differs quite a lot between aesthetics and therapeutic use.
Victor Floc'h: Thanks so much for taking my question, Victor Flot, BNP Paribas. A couple of questions on IPN10200. So, I mean, I think it's fair to say that the optimal target profile for that one differs quite a lot between aesthetics and therapeutic use, and notably when it comes to direction of action. So now that you have the full Phase II data in hand, I was just wondering whether you can discuss whether IPN10200 delivered an optimal profile, keeping its commercial potential intact in both opportunities. And then I understand that you don't really want to discuss your option, but I mean, just to understand, what would be like the tipping point when it comes to either go with a partner or either go with yourself?
Victor Floc'h: Thanks so much for taking my question, Victor Flot, BNP Paribas. A couple of questions on IPN10200. So, I mean, I think it's fair to say that the optimal target profile for that one differs quite a lot between aesthetics and therapeutic use, and notably when it comes to direction of action. So now that you have the full Phase II data in hand, I was just wondering whether you can discuss whether IPN10200 delivered an optimal profile, keeping its commercial potential intact in both opportunities. And then I understand that you don't really want to discuss your option, but I mean, just to understand, what would be like the tipping point when it comes to either go with a partner or either go with yourself?
Speaker #5: And notably, when it comes to duration of action. So now that you have the full face-to-data in hand, I was just wondering whether you can discuss whether IPSEN Q2 delivered an optimal profile, keeping its commercial potential intact in both opportunities.
Speaker #5: And then I understand that you don't really want to discuss your option. But I mean, just to understand, what would be the tipping point when it comes to either go with a partner or either go with yourself?
Speaker #5: Is it just about economics and whether you want to protect at least the kind of economics you have on this part with that one?
Victor Floc'h: Is it just about like economics and whether that you want to protect at least the kind of economics you have on this part with that one? And finally, on M&A, I was just wondering whether you can discuss whether you would be open to potentially stretch your firepower and your balance sheet beyond 2 times EBITDA, if the right opportunity arrives. Thanks so much.
Victor Floc'h: Is it just about like economics and whether that you want to protect at least the kind of economics you have on this part with that one? And finally, on M&A, I was just wondering whether you can discuss whether you would be open to potentially stretch your firepower and your balance sheet beyond 2 times EBITDA, if the right opportunity arrives. Thanks so much.
Speaker #5: And finally, on M&A, I was just wondering whether you can discuss whether you would be open to potentially stretch your firepower in your balance sheet beyond two times EBITDA if the right opportunity arises.
Speaker #5: Thanks so much.
David Loew: Perhaps, Victor, on your first question, can you just clarify why you are saying that the optimal target profile would be different? That's not something that we would subscribe to.
Speaker #4: Perhaps, Victor, on your first question, can you just clarify why you are saying that the optimal target profile would be different? That's not something that we would subscribe to.
David Loew: Perhaps, Victor, on your first question, can you just clarify why you are saying that the optimal target profile would be different? That's not something that we would subscribe to.
Speaker #5: OK. No, I mean, I think it's I mean, what do we understand in the past is that for aesthetics use, I mean, physicians were pretty happy with the six months duration of dosing, even though at the same time for therapeutic use, I think we all are looking for the longer duration as possible.
Victor Floc'h: Okay. No, I mean, I think it's, I mean, what, what we understand in the past is that, for aesthetics use, I mean, physicians were pretty happy with the six months duration of dosing, even though, at the same time, for therapeutic use, I think we all looking for the longer duration as possible. So, maybe you don't agree with that, but so, yeah, I was just wondering whether you could discuss the target profile you've seen with the IPN10200.
Victor Floc'h: Okay. No, I mean, I think it's, I mean, what, what we understand in the past is that, for aesthetics use, I mean, physicians were pretty happy with the six months duration of dosing, even though, at the same time, for therapeutic use, I think we all looking for the longer duration as possible. So, maybe you don't agree with that, but so, yeah, I was just wondering whether you could discuss the target profile you've seen with the IPN10200.
Speaker #5: So maybe you don't agree with that. But, so, I was just wondering whether you could discuss the target profile you've seen with the IPSEN Q2.
Speaker #3: Yeah. First, I would like to bring this back to data, right? When you look at none or mild in aesthetics at six months, most of the BoNTA's have actually shown that—you can go and look at the labels of these different drugs.
David Loew: Yeah. First, I would like to bring this back to data, right? When you look at none or mild in aesthetics at six months, most of the bond As have actually shown, and you can go and look at the labels of these different drugs. Most of them are between 20 and 30 percent. And so here, what we have said is we have seen a majority of patients achieving non or mild, and so that data is gonna be presented. So in that sense, you know, why many companies are saying, well, some patients are satisfied or they see still some effect and et cetera, I would just bring this back to, you know, the endpoints of non or mild, because that's usually what is being measured in the clinical trials.
David Loew: Yeah. First, I would like to bring this back to data, right? When you look at none or mild in aesthetics at six months, most of the bond As have actually shown, and you can go and look at the labels of these different drugs. Most of them are between 20 and 30 percent. And so here, what we have said is we have seen a majority of patients achieving non or mild, and so that data is gonna be presented. So in that sense, you know, why many companies are saying, well, some patients are satisfied or they see still some effect and et cetera, I would just bring this back to, you know, the endpoints of non or mild, because that's usually what is being measured in the clinical trials.
Speaker #3: Most of them are between 20 and 30 percent. And so here, what we have said is we had seen a majority of patients achieving none or mild.
Speaker #3: And so that data is going to be presented. So in that sense, while many companies are saying, well, some patients are satisfied or they see still some effect and et cetera, I would just bring this back to the endpoints of none or mild because that's usually what is being measured in the clinical trials.
Speaker #3: So in that sense, with that statement, I think the profile that we want to see in aesthetics and therapeutics is actually the same. You want to see a very rapid onset of action.
David Loew: So in that sense, with that statement, I think the profile that we wanna see in aesthetics and therapeutics is actually the same. You wanna see a very rapid onset of action, you wanna see a good one-month efficacy, and you wanna see a prolonged duration. This is important not just in aesthetics, but also in therapeutics, obviously, for example, in spasticity, migraine, or cervical dystonia, where it can also help alleviate the healthcare system, you know, utilization, because patients need to get less often to the doctor. So I don't know if that answers your question.
David Loew: So in that sense, with that statement, I think the profile that we wanna see in aesthetics and therapeutics is actually the same. You wanna see a very rapid onset of action, you wanna see a good one-month efficacy, and you wanna see a prolonged duration. This is important not just in aesthetics, but also in therapeutics, obviously, for example, in spasticity, migraine, or cervical dystonia, where it can also help alleviate the healthcare system, you know, utilization, because patients need to get less often to the doctor. So I don't know if that answers your question.
Speaker #3: You want to see a good one-month efficacy, and you want to see a prolonged duration. This is important not just in aesthetics, but also in therapeutics, obviously.
Speaker #3: For example, in spasticity, migraine, or cervical dystonia, where it can also help alleviate the health care system, utilization because patients need to get less often to the doctor.
Speaker #3: So I don't know if that answers your question. Yeah. Thank you. Then on your second, as I said, we are looking at all options.
Aymeric Le Chatelier: Definitely. Thank you.
Aymeric Le Chatelier: Definitely. Thank you.
David Loew: Yeah. Thank you. Then on your second, as I said, we are looking at all options. We're not gonna comment on this right now. And then on your third questions on, you know, the use of our firepower, I'll let Aymeric comment on the stretching the firepower.
David Loew: Yeah. Thank you. Then on your second, as I said, we are looking at all options. We're not gonna comment on this right now. And then on your third questions on, you know, the use of our firepower, I'll let Aymeric comment on the stretching the firepower.
Speaker #3: We are not going to comment on this right now. And then on your third questions on the use of our firepower, I'll let Aymeric comment on the stretching the firepower.
Speaker #4: Yeah. So Victor, just to clarify, we are today operating clearly under a maximum debt of two times EBITDA, which is fully aligned with our investment-grade rating.
Aymeric Le Chatelier: Yeah. So Victor, just to clarify, we are today operating clearly on the maximum debt of 2x EBITDA, which is fully aligned with our investment grade rating. This give us a EUR 3.2 billion firepower on top of our very strong free cash flow, EUR 1 billion this year, with a very ambitious guidance that we have. This EUR 1 billion should even increase in 2026. So we don't see any reasons for using more than the 2x EBITDA. Having said that, the board has always said that they will consider if there were to be a unique opportunity and ability to slightly stretch that, but this is not today our priority.
Aymeric Le Chatelier: Yeah. So Victor, just to clarify, we are today operating clearly on the maximum debt of 2x EBITDA, which is fully aligned with our investment grade rating. This give us a EUR 3.2 billion firepower on top of our very strong free cash flow, EUR 1 billion this year, with a very ambitious guidance that we have. This EUR 1 billion should even increase in 2026. So we don't see any reasons for using more than the 2x EBITDA. Having said that, the board has always said that they will consider if there were to be a unique opportunity and ability to slightly stretch that, but this is not today our priority.
Speaker #4: This gives us a 3.2 billion euro firepower on top of our very strong free cash flow, 1 billion this year with a very ambitious guidance that we have this 1 billion should even increase in 2026.
Speaker #4: So we don't see any reasons for using more than the two times EBITDA. Having said that, the board has always said that they will consider if they were to be unique opportunity and ability to slightly stretch that.
Speaker #4: But this is not today our priority.
Speaker #5: OK. Thank you, operator.
David Loew: Okay. Thank you, operator.
David Loew: Okay. Thank you, operator.
Speaker #1: Thank you. We will now take the next question from the line of Lucy Codrington from Jefferies. Please go ahead.
Operator: Thank you. We will now take the next question from the line of Lucie Codrington from Jefferies. Please go ahead.
Operator: Thank you. We will now take the next question from the line of Lucie Codrington from Jefferies. Please go ahead.
Lucy Codrington: Hi. Thank you for taking my questions. Only a few left. Just, I was wondering if you could go into a bit more detail in terms of your expectations for Dysport this year, both in terms of aesthetics and therapeutics. And with that, any potential impact that you might expect as the Relaxis launches continue, and then any update on what the aesthetics environment is like in the US and other markets at the moment. Secondly, on Somatuline, when you talked about the guide, you said growth. So are we—I know you're, it's somewhat dependent on the entry of generics, but should we be expecting growth on the numbers reported in 2025, or still some decline? And then secondly, finally, any milestones that we should be factoring in for this year? Thank you.
Lucy Codrington: Hi. Thank you for taking my questions. Only a few left. Just, I was wondering if you could go into a bit more detail in terms of your expectations for Dysport this year, both in terms of aesthetics and therapeutics. And with that, any potential impact that you might expect as the Relaxis launches continue, and then any update on what the aesthetics environment is like in the US and other markets at the moment. Secondly, on Somatuline, when you talked about the guide, you said growth. So are we—I know you're, it's somewhat dependent on the entry of generics, but should we be expecting growth on the numbers reported in 2025, or still some decline? And then secondly, finally, any milestones that we should be factoring in for this year? Thank you.
Speaker #6: Hi. Thank you for taking my questions only a few left. Just I was wondering if you could go into a bit more detail in terms of your expectations for this board this year, both in terms of aesthetics and therapeutics.
Speaker #6: And with that, any potential impact that you might expect as the Royal Feeders launches continue? And then any update on what the aesthetics environment is like in the US and other markets at the moment?
Speaker #6: Secondly, on semantically, when you talked about the guide, you said growth. So I know you're it's somewhat dependent on the entry of generics. But should we be expecting growth on the numbers reported in 2025?
Speaker #6: Or still some decline? And then secondly, finally, any milestones that we should be factoring in for this year? Thank you.
Speaker #4: Thank you, Lucy. On this board, we are expecting good high single-digit growth in both markets, aesthetics and therapeutics. We do not anticipate any impact from Royal Feeders because that's a it's a different market.
David Loew: Thank you, Lucie. On Dysport, we are expecting good, high single-digit growth in both markets, aesthetics, and therapeutics. We do not anticipate any impact from Relaxis because that's a different market. You know, there is a market segment which is open for liquids. I would say the majority of the market is on great constitution because many of the physicians actually like to dilute to their liking. We have seen this with the Elluxea launch as well. We don't really foresee any cannibalization. It's quite the contrary. I think both are gonna drive growth. On aesthetics in the US, the market has slowed down a little bit, but our particle, Lerma, is performing very, very well, gaining market share, so we are very pleased with that performance.
David Loew: Thank you, Lucie. On Dysport, we are expecting good, high single-digit growth in both markets, aesthetics, and therapeutics. We do not anticipate any impact from Relaxis because that's a different market. You know, there is a market segment which is open for liquids. I would say the majority of the market is on great constitution because many of the physicians actually like to dilute to their liking. We have seen this with the Elluxea launch as well. We don't really foresee any cannibalization. It's quite the contrary. I think both are gonna drive growth. On aesthetics in the US, the market has slowed down a little bit, but our particle, Lerma, is performing very, very well, gaining market share, so we are very pleased with that performance.
Speaker #4: There is a market segment which is open for liquids. I would say the majority of the market is on great constitution because many of the physicians actually like to dilute to their liking.
Speaker #4: We have seen this with the illusions launch as well. So we don't really foresee any cannibalization. It's quite the contrary. I think both are going to drive growth.
Speaker #4: Then on aesthetics in the US, the market has slowed down a little bit. But our partner, Galderma, is performing very, very well. Gaining market share.
Speaker #4: So we are very pleased with that performance. On semantically, yes, we do anticipate growth versus 2025 because of what Aymeric just said before, is you have of course the volume gain of the generics not being there.
David Loew: On simethicone, yes, we do anticipate growth versus 2025 because of what Aymeric just said before, is you have, of course, a volume gain of the generics not being there, but you also have some potential pricing upside. So there is this kind of double effect, if you want, versus the baseline of 25. And then I wasn't quite sure I understood your milestone question.
David Loew: On simethicone, yes, we do anticipate growth versus 2025 because of what Aymeric just said before, is you have, of course, a volume gain of the generics not being there, but you also have some potential pricing upside. So there is this kind of double effect, if you want, versus the baseline of 25. And then I wasn't quite sure I understood your milestone question.
Speaker #4: But you also have some potential pricing upside. So there is this kind of double effect. If you want versus the baseline of 2025. And then I wasn't quite sure I understood your milestone question.
Speaker #3: I think I get the question on milestone. I think this is related to our other revenue which, as I said during the presentation, have increased significantly in 2025.
Aymeric Le Chatelier: I think I get the question on milestone. I think this is related to our other revenue-
Aymeric Le Chatelier: I think I get the question on milestone. I think this is related to our other revenue-
David Loew: Oh, okay.
David Loew: Oh, okay.
Aymeric Le Chatelier: - which, as I said during the presentation, have increased significantly in 2025. Our other revenue are made of both royalties that we receive from partners and some milestones. Some of the milestones are non-recurring. That's why we were indicating that our margin in 2026 is gonna be slightly impacted by a slightly lower level of milestones, and other level of other revenue, while we still continue to have a strong dynamic on the royalty side, which is directly linked to the high single-digit expected growth for Dysport with our partner.
Aymeric Le Chatelier: - which, as I said during the presentation, have increased significantly in 2025. Our other revenue are made of both royalties that we receive from partners and some milestones. Some of the milestones are non-recurring. That's why we were indicating that our margin in 2026 is gonna be slightly impacted by a slightly lower level of milestones, and other level of other revenue, while we still continue to have a strong dynamic on the royalty side, which is directly linked to the high single-digit expected growth for Dysport with our partner.
Speaker #3: Our other revenue are made of both royalties that we receive from partners and some milestones. Some of the milestones are non-recurring. That's why we were indicating that our margin in 2026 is going to be slightly impacted by slightly lower level of milestones.
Speaker #3: And other level of other revenue, while we still continue to have a strong dynamic on the royalties side, which is directly linked to the high single-digit expected growth for this board with our partner.
Speaker #4: Thank you, Lucy. I think we have no more questions. So this wraps up our 2025 conference. Thank you for your attendance. Back to you, operator.
David Loew: Thank you, Lucie. I think we have no more questions, so this wraps up our 2025 conference. Thank you for your attendance. Back to you, operator.
David Loew: Thank you, Lucie. I think we have no more questions, so this wraps up our 2025 conference. Thank you for your attendance. Back to you, operator.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.