Q2 2025 Ipsen SA Earnings Call
David Loew: To welcome you this afternoon to our H1 2025 results presentation, 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 the first half of 2025 and on the future opportunities and platforms for growth. 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 my comments on growth will be based on constant exchange rates. Please turn to slide three. I am going to take you through the presentation of our latest business update, followed by Christelle Huguet, Head of Research and Development, who will provide an R&D update, while our CFO, Aymeric Chatelier, will take you through the financials. At the end of the presentation, all three of us will be participating in the question and answer session.
You're welcome this afternoon to our H1 2025 results presentation, which can also be found on ipsen.com.
I want to use the time we have together to focus on the progress that’s been delivered in the first half of 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. Also contained within this presentation, all 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 a head of research and development who will provide an R&D update, while our CFO will take you through the financials.
David Loew: Let's begin by looking at today's highlights. Please turn to slide four. Turn to slide five. Today's headlines illustrate how we are continuing to produce sustainable growth. Total sales grew by 11.4% in the first half of 2025, accompanied by a core operating margin of 36%. As you have seen, we announced last week the European Commission approval of Cabometyx in neuroendocrine tumors, an area where Ipsen has a strong legacy. During this first half, we also made good progress with our pipeline, including the entry in phase two of IPN10-200, our long-acting neurotoxin AD, in cervical dystonia. This milestone highlights the fourth study in the Global Long-Acting Neurotoxin Development Plan in therapeutic and aesthetic indications. Pipeline progress also came in the form of the EMEA regulatory submission of Tovorafenib for pediatric low-grade glioma earlier in the year.
At the end of the presentation, all three of us will be participating in the question-and-answer session.
Let's begin by looking at today's highlights. Please turn to slide 4.
Turn 2, slide 5.
Today's headlines illustrate how we are continuing to produce sustainable growth. Total sales grew by 11.4% in the first half of 2025, accompanied by a core operating margin of 36%. As you have seen, we announced last week the European Commission's approval of cover metrics in neuroendocrine tumors, an area where Ipsen has a strong legacy.
During this first half, we also made good progress with our pipeline, including the entry into Phase 2 of IPN-10200, our long-acting neurotoxin additive in cervical. This aligns with our milestone highlights, marking the fourth study in the global long-acting neurotoxin development plan in therapeutic and aesthetic indications.
David Loew: In the second half, we anticipate a pivotal trial redirect for Fidrisertib in FOP, and excitingly, our first proof of concept data for our long-acting neurotoxin in aesthetics. Christelle will provide more details on these, as well as on the development of elafibranor in PBC and PSC in her section. Lastly, based on the solid momentum and the strong performance of this first half, we are pleased to upgrade our full-year guidance. We now expect total sales growth greater than 7% at constant exchange rates and a core operating margin greater than 32%. Aymeric will provide more details in his section. Please turn to slide six. Our sales in H1 delivered a solid 11.4% growth, fueled by all three therapeutic areas, with Q2 very much aligned with Q1 performance. Oncology has performed well with H1 sales growth of 6.4%.
Cyclone progress also came in the form of the EMA regulatory submission of typography for Pediatric Low-Grade Goma earlier in the year.
In the second half, we anticipate a pivotal trial ready for fit research, the team in FOP, and excitingly, our first proof of concept data for our long-acting neurotoxin in aesthetics.
Crystal will provide more details on these, as well as on the development of a Fibonacci and PSC, in her section.
Lastly, based on the solid momentum and the strong performance of this first half, we are pleased to upgrade our full-year guidance. We now expect total sales growth greater than 7%, the content exchange rate, and the core operating margin greater than 32%.
Eric will provide more details in his section. Please turn to slide 6.
David Loew: Rare disease continued to have the most impressive performance, driven by the sustained success of IQIRVO and the strong performance of Bylvay. Neuroscience with Dysport continued to deliver high single-digit growth. I now turn to oncology for more details. Please turn to slide seven. Starting with Somatuline, sales were up by 14.1%. Both Europe and the U.S. continued to benefit from shortages of generic lanreotide. We do anticipate more lanreotide generic competition with potential entry in the second half of the year. Cabometyx sales were slightly down by 0.2%, with solid performance in Europe from increased volumes offset by shipment phasing and increased competition in the rest of the world. We're confident that Cabometyx should continue to grow its market share in the current indication in renal cell carcinoma and progressively launch in the neuroendocrine tumor indication.
Our sales in H1 delivered a solid 11.4% growth, fueled by all three therapeutic areas, with Q2 very much aligned with Q1 performance. Oncology has performed well, with H1 sales growth of 6.4%. Rare disease continues to have the most impressive performance, driven by the sustained success of Aural and the strong performance of Neuroscience. These Sports continued to deliver high single-digit growth.
I now turn to oncology for more details. Please turn to Slide 7.
Starting with some, ethylene sales were up by 14.1%. Both Europe and the U.S. continue to benefit from shortages of generic Landria type. We do anticipate more retail generic competition with potential entry in the second half of the year.
David Loew: Bylvay sales were up by 0.5% as we experienced volume growth in Europe and China, despite continued competition and some pricing pressure in some countries. ONIVYDE sales grew by 6.5%, with moderate growth in the U.S., driven by the first-line metastatic pancreatic ductal adenocarcinoma. We recognize that it will take time to drive first-line differentiation and address some challenges around access to payers. Now let's turn to rare disease. Please turn to slide eight. On rare disease, Bylvay continues to perform nicely, with H1 sales of $87 million growing by 53.7%, driven by strong demand in the U.S. and in Europe in both PFIC and Alagille Syndrome indications. We also had an increase in contribution from the rest of the world, with access and reimbursement now secured in 17 countries. Turning to IQIRVO, the launch continues to track very well, with sales reaching $59 million this semester.
Carbon metric sales were slightly down by 0.2%, with solid performance in Europe. This was driven by increased volumes offset by shipment phasing and increased competition in the rest of the world. We're confident that Carbonetics should continue to grow its market share in the current indication of renal cell carcinoma and will progressively launch in the neuroendocrine tumor indication.
Pepsi sales were up by 0.5% as we experienced volume growth in Europe and China, despite continued competition.
Pricing pressure in some countries.
Only by sales grew by 6.5%, with model growth in the U.S. driven by the first line, metastatic pancreatic ductal adenocarcinoma. We recognize that it will take time to drive first-line differentiation and address some challenges around access to payers. Now, let's turn to rare disease. Please turn to slide 8.
On the rare disease bill, Ipsen continues to perform nicely with H1 sales of $87 million, growing by 53.7%, driven by strong demand in the U.S. and in Europe in both the PICC and allergy syndrome indications.
We also had an increasing contribution from the rest of the world with access and reimbursement. Now secured in 17 countries.
David Loew: In Q2, we saw an acceleration in the U.S., with a 65% growth quarter over quarter, driven by an increasing uptake from new patients and switches from Ocaliva. Europe was also very strong, with sales mainly from Germany and the U.K., and launches initiated in Spain and Italy in June. Moving to neuroscience, let's turn now to slide nine. Dysport delivered another solid performance with H1 sales growth of 9.7%. In aesthetics, sales grew by 17.5%, driven by continued expansion in most territories, including the U.S., Europe, and the rest of the world, and by a strong performance from our partner Galderma, who continues to gain market share in key countries and a solid growth in our IPSEN territory. On the therapeutic side, Dysport showed solid and consistent demand growth across all geographies.
The launch continues to track very well with sales reaching $59 million. This semester in Q2, we saw an acceleration in the US with a 65% growth quarter over quarter, driven by an increasing uptake from new patients and switches from Okala.
Europe was also very strong with sales, mainly from Germany and the UK, and launches initiated in Spain and Italy in June.
Moving to Neuroscience. Let's turn now to slide 9.
This board delivered another solid performance with H1 sales growth of 9.7%. In Aesthetics, sales grew by 17.5%, driven by continued expansion in most territories, including the US, Europe, and the rest of the world, as well as by strong performance from our partner Galderma, who continued to gain market share in key countries and solid growth in our IPS and territories.
David Loew: In the U.S., notably, we continued to gain market share in our specificity indications with strong double-digit sales growth. Reported sales were, however, flat due to an adverse phasing of orders in Brazil. Supported by solid market growth in both indications and strong execution, we are confident that Dysport should continue to deliver high single-digit sales growth in the short, mid, and long term. Now I would like to present the upcoming catalysts. Please turn to slide 10. In the second half of 2025, we are expecting updates in rare disease and neuroscience. Starting with rare disease, we should report the pivotal FALCON trial results for Fidrisertib in FOP. Secondly, in neuroscience, we are expecting the proof of concept data for LAMD in aesthetics.
On the therapeutic side, this work showed solid and consistent demand growth across all geographies in the U.S. Notably, we continue to gain market share in our specificity indications with strong double-digit sales growth.
Reported sales were, however, flat due to an adverse phasing of orders in Brazil.
Supported by solid market growth in both indications and strong execution, we are confident that Forge will continue to deliver high single-digit sales growth in the short, mid, and long term.
Now, I'd like to present the upcoming catalysts. Please turn to slide 10.
In the second half of 2025, we are expecting updates in rare diseases and neuroscience.
David Loew: Looking ahead, 2026 is going to be a busy year for the pipeline, with several anticipated phase 3 data across all three therapeutic areas, including for Bylvay, IQIRVO, Tovorafenib, as well as migraine trial for Dysport. With that, I will now hand over to Christelle Huguet, who will provide more details on our pipeline and those exciting milestones. Please turn to slide 11.
Starting with rare disease, we should report the pivotal Falcon trial results for fed research tip in FOP. Secondly, in neuroscience, we're expecting the proof of concept data readout for Land in Aesthetics.
Christelle Huguet: Thank you, David. Good morning and good afternoon. Please turn to slide 12. As David already mentioned, last week we were delighted to receive the European Commission approval for Cabometyx in advanced pancreatic and extra-pancreatic neuroendocrine tumors. This approval was based on the strong results of the CABOMETRYX study displayed here on the graph, which showed a significant improvement in EDM progression-free survival for patients treated with Cabometyx versus placebo. Working within the NET community for more than 35 years, we recognize that patients require multiple lines of therapy for this slow-growing and chronic form of cancer. We are now focused on bringing this important treatment to patients. Please turn to slide 13 and our pipeline. We continue to have a strong and differentiated pipeline that has advanced in all three therapeutic areas in the first half of 2025.
Looking ahead, 2026 is going to be a busy year for the pipeline, with several anticipated phase 3 data reads across all three therapeutic areas, including for bill weights like Cuervo TV, as well as migraine trial readouts for this part. I’ll now hand over to Crystal, who will provide more detail on our pipeline and those exciting milestones. Please turn to slide 11.
Thank you, David. Good morning and good afternoon. Please turn to slide 12.
As David already mentioned last week, we were delighted to receive the European Commission approval for Cabometyx in advanced pancreatic and extra-pancreatic neuroendocrine tumors.
This approval was based on a strong resource of the cabinet study displayed here on the graph, which showed a significant improvement in median progression-free survival for patients treated with capecitabine versus placebo.
Working within any community for more than 35 years, we recognize that patients require multiple lines of therapy for the slow-growing and chronic form of cancer.
We are now focused on bringing this important treatment to patients.
Please stand just like Q2 and our pipeline.
Christelle Huguet: In oncology, we have established a strong expertise in the MAPKINESE pathway, starting with Tovorafenib, a second-generation RAF inhibitor, and the Firefly II phase 3 study in untreated pediatric low-grade glioma patients. IPN 1195, our newest third-generation RAF inhibitor, has entered the clinic in April, alongside IPN 1194, which selectively inhibits ERK, also in the MAPKINESE pathway. Both IPN 1194 and IPN 1195 are being evaluated in a number of solid tumors. In rare disease, we continue to grow our rare liver portfolio, both in pediatric with Bylvay in biliary atresia and in adults, in PSC and PBC with IQIRVO. I will share more on the ELMOD study in a minute and also update you on the FALCON study in FOP. In neuroscience, we continue to evaluate the potential of our portfolio in both chronic and episodic migraine.
We continue to have a strong and differentiated pipeline that has advanced in all three therapeutic areas in the first half of 2025.
In Oy, we have established a strong expertise in the mmmkay pathway, starting with Tovo, a RAF inhibitor in its second generation. RAF inhibitor and the Firefly TOFA-3 study in untreated pediatric low-grade glioma. Patient IPN-1195, our newest third-generation Ras inhibitor, has entered the clinic in April alongside IPN-1194, which selects.
Actively inhibits.
Also, in the MES pathway, both IP and 1194, and IPN and 1195 are being evaluated in a number of solid tumors.
In rare disease, we continue to grow our rare liver. Good for you both in pediatric, with B in Birria, and in adults, in PSC and PBC with Aero. I will share more on the Elmwood study in the unit and also update you on the Fountain study in FOP.
Christelle Huguet: We've also just shared that we have added a fourth phase 2 trial in our LAMD program, with CATALPA evaluating IPN10-200 in cervical dystonia. Please turn to slide 14 for more details on the rare disease portfolio and starting with fibrodysplasia ossificans progressiva or FOP. FALCON is a phase 2 registration study evaluating the change in heterotopic ossification volume from baseline to 12 months and assessed by whole body CT scan. Importantly, Fidrisertib selectively inhibits the mutated form of ALK2 that is found to be a driver in FOP. We expect this data to read out in the second half of 2025. Please turn to slide 15. With an update now on the rare liver disease portfolio, first starting with primary biliary cholangitis, at the recent EASL reading, we shared late-breaking data from the Phase 3 ELATIVE study for IQIRVO in PBC.
In neuroscience, we continue to evaluate the potential of our portfolio in both chronic and episodic migraine.
We've also just shared that we have added a fourth face to trial in our land program with Catalpa, evaluating IPN-10200 in cervical dystonia.
For more details on the rare disease portfolio, starting with fibrous dysplasia or CIFIC count, Progressive.
Falcon is a Phase 2 registration study, evaluating the change in error topic. Specification volume Bass.
From Baseline to 12 months.
And assessed by whole body CT scan.
Importantly, feed research selectively inhibits the mutated form of OUT that is found to be a driver in FOP. We expect this data to read out in the second half of 2025.
Please turn to cite 15.
Christelle Huguet: Additional analysis showed that at week 52 of treatment, 67% of patients treated with elafibranor had a clinically meaningful improvement in fatigue compared with 31% of patients treated with placebo. Importantly, this effect was also shown to be independent of the reduction in pruritus. Alongside these data, we presented evidence from a comprehensive proteomic analysis that showed the BPA alpha activation is linked to the fatigue improvement in PBC. Please turn to slide 16. Moving to PSC, at EASL, we also shared the results of our Phase 2 ELMOD study evaluating the safety and efficacy of elafibranor in primary sclerosing cholangitis, a rare liver disease that currently has no approved treatment option. In this study, elafibranor showed a favorable safety profile and demonstrated dose-dependent efficacy at 12 weeks versus placebo across a number of endpoints.
With an update now on the rare liver disease portfolio, first starting with primary biliary cholangitis (PBC), scientists at the recent EEL meeting shared late-breaking data from the Phase 3 RELATE study before I Cuervo in PDC.
Additional analysis shows that there are weak 52 of treatments.
67% of patients treated with fibrina had a clinically meaningful improvement in fatigue, compared with 31% of patients treated with visible.
Importantly, this effect was also shown to be independent of the reduction in pitis.
Alongside these data, we presented evidence from a comprehensive proteomic analysis.
That shows that the people Alpha activation is linked to the fatty improvement in PBC.
Please turn to slide 16.
Moving to PSC.
That is all. We also share the results of our Phase 2 Elwood study, evaluating the safety and efficacy of Alf. Fibrina in primary sclerosing colitis, a rare disease that currently has no approved treatment options.
In the study l.
Christelle Huguet: In particular, significant improvement in liver biochemical parameters, including alkaline phosphatase, shown on the graph on your left. In the center graph, stabilization of non-invasive markers, including enhanced liver fibrosis, ELF. Of note, the changes in ELF are greater in patients with moderate to severe fibrosis at baseline. Finally, the graph on the right showed a significant improvement in pruritus, and this was observed using the Worth-HNRS score at the 128 dose. We are now engaging with regulatory agencies to decide on the next steps of our clinical development program for this indication. Please turn to slide 17. In neuroscience, the next data readout is the LANTEC Phase 2 in multi-stage dose escalation study evaluating the safety and efficacy of IPN10-200 in moderate to severe upper facial lines.
Show the favorable safety profile and demonstrate those dependent efficacy at 12 weeks versus visible across a number of endpoints in particular.
Significant improvement in liver biochemical parameters, including alkaline phosphatase, is shown on the graph on your left.
The Fanta graph.
Stabilization of non-invasive markers, including enhanced liver fibrosis (ELF).
Of nodes. The changes in ELF are greater in patients with moderate to severe fibrosis and baseline.
And finally, the graph on the right shows a significant improvement in fruit.
And this was observed using the worst HNRS score at the 128 dose.
We are now engaging with regulatory agencies to decide on the next steps of our clinical development program for this indication.
Please turn to slide 17.
Christelle Huguet: The proof of concept is determined in the stage one, where we are evaluating IPN10-200 in glabellar lines, and we expect these data in the second half of 2025. The stage two of this study has already started and includes forehead and lateral canthal lines. We are excited to see these results coming from the stage one in the coming months, and a positive proof of concept will support a Phase 3 start. I would now like to hand over to Aymeric Chatelier for the details of our H1 financials. Turn to slide 18, please.
In neuroscience, the next data result is the Atlantic Phase 2 in multi-stage. This is a dose escalation study evaluating the safety and efficacy of Ip and 10,200 in moderate to severe upper facial lines.
The proof of concept is determined in Stage 1, where we are evaluating IP and 10200 in glabella lines. We expect to have these data in the second half of 2025.
The stage 2 of this 30 years has already started and includes forehead and lateral tantal lines.
We're excited to see these results. Coming from Stage 1 in the coming months, a positive proof of concept will support a Phase 3 start.
Aymeric Chatelier: Thank you, Christelle, and hello everyone. I will now take you through the detail of our financial performance in the first half of this year, as well as our guidance for 2025. Please turn to slide 19. We delivered another set of strong financial results in the first half across sales, core operating income, and cash flow. Our total sales, over €1.8 billion, grew by 11.4% at constant exchange rates. Our core operating income grew by 21.9% to €656 million, in line with our free cash flow, increasing also by 22% to €483 million. Given this strong performance and our solid balance sheet with no debt, we now have, at the end of June, an updated firepower available for external innovation of €3 billion. Let's go more in the detail of those financials in the following slide. Please turn to slide 20.
I would now like to hand over to Emmer for the details of our H Fund financials. Turn to slide 18, please.
Thank you, Crystal. And hello, everyone. I will now take you through the details of our financial performance in the first half of this year, as well as our guidance for 2025.
Please turn to slide 19.
We delivered another set of strong financial results in the first half across sales, cooperating income, and cash flow.
Our total sales over €1.8 billion grew by 11.4% at constant exchange rates, while operating income grew by 21.9% to €656 million, in line with our free cash flow, increasing also by 22% to €483 million.
At the end of June, an updated firepower available for external innovation of €3 billion.
Let's go more into the details of the financials. In the following slides, please turn to slide 20.
Aymeric Chatelier: Starting with the P&L to core operating income, the growth in total sales of 11.4% at constant exchange rates translated into 9.7% at current rates, given the adverse currency movement mainly from emerging markets. Gross margin increased by 2.1 percentage points, driven by a favorable product mix and higher author revenue from partners. R&D costs increased by 12.8% to reach a ratio of 20.1% of total sales, driven mainly by increased investment for Dysport in migraine, long-acting toxin in aesthetic and therapeutic, and our early-stage oncology assets. SG&A costs increased by only 5.6%, with a ratio to sales at 33.3%, improving by 1.3 percentage points, reflecting our commercial investment to support the launches but also the impact of our efficiency programs. As a consequence, our core operating income increased by 21.9%, with a core operating margin standing at 36% of sales and an improvement of 3.6 percentage points.
Starting with the P&L to cooperating income, the growth in total sales of 11.4% at constant rates translated into 9.7% at current rates, given the adverse currency movement mainly from Emerging Markets.
Gross margin increased by 2.1 percentage points, driven by a favorable product mix and higher other revenue from partners.
R&D costs increased by 12.8% to reach a ratio of 20.1% of
sales.
Driven mainly by increased investment for this sport in migraine, longer-acting toxin in aesthetic and therapeutic, and our early-stage oncology assets.
SG&A costs increased by only 5.6%, with the ratio to sales at 33.3%, improving by 1.3 percentage points. This reflects our commercial investment to support the launches, but also the impact of our efficiency programs.
Aymeric Chatelier: Please turn to slide 21. IFRS operating income and consolidated net profit increased both by more than 40%, thanks to lower restructuring and author operating expenses, lower financial expenses, and despite increment losses recognized for €53 million in relation with discontinued early-stage assets, as well as slightly higher income tax. Please turn to slide 22. Finally, on cash flow, we continue to generate strong free cash flow this year and have a strong balance sheet with a cash position of €488 million at the end of June. Free cash flow increased by 22.8%, driven by EBITDA growth, sound management of capital expenditures, and working capital. Net investment included payments related to regulatory and commercial milestones.
As a consequence of cooperating, income increased by 21.9%, with a core operating margin standing at 36% of sales, showing an improvement of 3.6 percentage points.
Please turn to slide 21.
IFRS operating income and consolidated net profit both increased by more than 40%, thanks to lower restructuring and other operating expenses.
Lower financial expenses and, despite impairment losses recognized for €53 million in relation to this continued early-stage asset, as well as likely higher income tax.
please turn to slide 22.
Finally, on cash flow, we continue to generate strong free cash flow this year and have a strong balance sheet with a cash position of €488 million at the end of June.
Free cash flow increased by 22.8%, driven by Obidos, some management of capital expenditures, and working capital.
Aymeric Chatelier: With a net cash position of €488 million at the end of June and based on a maximum 2 times net debt to EBITDA, we have a firepower of €3 billion available for external innovation. Let us now move to 2025 guidance and turn to slide 23. Based on this solid momentum in the first half of the year and that very strong performance, we are pleased to upgrade our full-year 2025 guidance. First, we expect total sales to grow by more than 7% at constant exchange rates, as compared to our previous guidance of sales growth above 5%. We assume also a negative impact of 2 points from currencies based on the latest exchange rates during the month of June. This guidance assumes, as indicated by David Loew, a negative impact in H2 on Somatuline sales in the U.S.
Net investment, including payments related to regulatory and commercial milestones.
Position of €400 million and €88 million at the end of June. Based on the maximum two times debt to EBITDA, we have a firepower of €3 billion available for external innovation. Let's now move to 2025 guidance and turn to slide 23.
Based on this solid momentum in the first half of the year and that very strong performance, we are pleased to upgrade our full-year 2025 guidance.
First, we expect total sales to grow by more than 7% at a construction rate.
As compared to our previous guidance of sales, growth above 5%.
We also assume a negative impact of 2 points from currencies based on the latest exchange rate during the month of June.
Aymeric Chatelier: and in Europe, with a progressive resupply from the current generic and a potential entry of an additional generic. On the other side, we expect an accelerated sales growth from the rest of the portfolio, driven by the significant drop-off of IQIRVO in the U.S. and in Europe, as well as the growth of Cabometyx. On the other hand, we anticipate now a core operating margin greater than 32% of total sales, as compared to more than 30% in our previous initial guidance. It assumes, however, a lower level of profitability in the second half of the year, including additional R&D expenses from potential early or mid-stage external innovation opportunities, additional commercial investment to support our launches, and a lower level of other revenue than in the first half of the year. With all of that, I will now hand over back to David Loew. Please turn to slide 24.
This guidance assumes, as indicated by David, a negative impact in H2 on satellite sales in the US and in Europe, with a progressive resupply from the current generate and the potential entry of additional generics.
On the other side, we expect an accelerated sales growth from the rest of the portfolio driven by the significant progress of I in the U.S. and in Europe, as well as the growth of Carbonetics.
On the other hand, we anticipate now a Cooperative margin greater than 32% of total sales, as compared to more than 30% in our previous initial guidance.
It has to, however, a lower level of profitability in the second half of the year, including additional R&D expenses from potential early or mid-stage external innovation opportunities.
Additional commercial investment to support our launches and the lower level of other revenue in the first half of the year.
David Loew: Thank you, Aymeric. I will now move to the conclusion. Please turn to slide 25. We continue to deliver strong momentum and remain firmly on track to achieve our ambitions. I would like to leave you with three key messages. First, we intend to continue growing our top line, 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. Second, we remain committed to continuing our R&D investments and growing our internal pipeline while investing to support our current and future commercial launches. Finally, we have significant firepower to pursue external innovation. We remain disciplined but ambitious, and we are well positioned to seize the right opportunities to further strengthen our portfolio. With that, please turn to slide 26. This concludes our presentation, and we will now take your questions.
With all of that, I will now hand it over back to David. Please turn to slide 24.
Thank you, America. I will now move to the conclusion. Please turn to slide 25.
We continue to deliver strong momentum and remain firmly on track to achieve our ambitions. I'd like to leave you with three key messages. First, we intend to continue growing our top line, fueled by the performance of our existing portfolio and launches.
And our ability to deliver across both commercial and medical fronts.
Second, we remain committed to continuing our R&D investments and growing our internal pipeline while investing to support our current and future commercial launches.
Finally, we have significant firepower to pursue external innovation. We remain disciplined, but ambitious, and we are well positioned to seize the right opportunities to further strengthen our portfolio.
With that, please turn to slide 26.
David Loew: Operator, over to you.
Operator: Thank you very much. As a reminder, to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by as we compile the Q&A roster. Our first question comes from the line of Richard Parkes from JPMorgan. Your line is now open.
This concludes our presentation, and we will now take your questions. Operator, over to you.
Thank you very much. As a reminder, to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced.
2 withdrawals. Your question. Please press star 1 1 1 again.
Please stand by. This is your call to the Q&A roster.
Our first question comes from the line of Richard Belsa from JP Morgan. Your line is now open.
Richard Parkes: Hi, thanks for taking my question. Two questions, please. Just one on Somatuline. It seems like generics are always going to have supply issues. At what point do you think we can think about a substantial residual tail to the business? Where might that be? How should we think about the outlook maybe beyond 2025 or 2026? I suppose the profitability of the business during that period. Then a second question on IQIRVO launch. It is obviously going very strongly. How should we think about that and the level of use maybe off-label in other indications that might come through going forward in the coming months? Thanks very much.
Hi. Thanks for taking my question. Uh, 2 questions, please just just 1 on some athlete. Um uh you know, it seems uh like generics are always going to have supply issues. So um uh uh uh uh what point do you think we can think about a substantial residual tale to the business? Uh, where might that be? How should we think about the the out?
David Loew: Thanks a lot, Richard Parkes. On your first question, I mean, I have to say, of course, we were very pleased with our performance on Somatuline, and it also shows that it is very difficult to produce compounds. We had observed that Pharmathen is only coming back very slowly, delivering to a plant in Europe and Cipla, though they are slightly increasing. On Tanpharma, which had the approval last year in October, we do not see them on the market. Now, they are telling the market that they might come towards the second half in Europe. In the U.S., we have not heard anything. So it is correct that Somatuline is holding up very nicely, but we just want to be careful.
Looks maybe Beyond, uh, 25 for 26 and um, uh and and I suppose the profitability of the business uh, during that uh, period. And then a second question on um, uh, auro launch. Um, just obviously going very strongly, how should we think about, uh, that and uh, and the level of, uh, use maybe off label in in other indications that might come through, uh, going forward in the coming months. Thanks very much.
David Loew: Perhaps one day they are going to figure out how to produce it, and we will see a somewhat accelerated erosion. That is all I can say because we are not inside the production buildings of these companies, and it is hard to say how well they are doing on eventually ramping up. So I would assume that there is going to be a tail in the future, even because of those reasons that it is so hard to produce. On IQIRVO, we are, as you said, on a really nice trajectory. We are off to a great launch in the U.S., but also outside of the U.S. We have had, outside of the U.S., a substantial advance versus Gilead, and we have also seen the withdrawal of Ocaliva in Europe.
Thanks a lot, Richard. Um, on your first question, I mean, I have to say, of course, we're very pleased with our performance on some alone, and it also shows that it is very difficult to produce, uh, compound. So we have observed that Pharma 10 is only coming back very slowly, um, you know, delivering to Advanced in Europe and simpler. So they're slightly increasing, and on some pharma, which had the approval last year in October, we don't see them on the market. Um, now, you know, they're telling the market that they might come towards the second half in Europe. In the US, we have not heard anything. So it's correct that, you know, systemically in is holding up, uh, very nicely, but we just want to be careful. You know, perhaps one day they are going to figure out how to produce it, and we will see it somewhat accelerated erosion. Um, you know.
That's all I can say because we're not inside the production buildings of these companies. It's hard to say how well they are doing in eventually ramping up. So, I would assume that there is going to be a tail in the future as well, because of those reasons that it's so hard to produce.
David Loew: So that has accelerated things for sure, and we have been able to capture a lot of switch patients as well. We are only about to launch now in other large markets. We just got the reimbursement in June in Italy and also in Spain, so we are ramping up there. So things are going very well. In terms of off-label use, PSC, I guess you would allude to because we have shown results in May at the EASL conference, which looked very promising, and we are going to discuss these results with the FDA and potential way forward in PSC. But I cannot really comment on off-label. As you know, we are not promoting it, obviously. We can only have scientific exchanges through our MSLs when we get questions. But so far so good.
On a corvo. Um, we are as you said on a really nice trajectory, uh, we're off to a great launch in the US, but also, outside of the us, we have had outside of the US is substantial Advance versus Gilead. And we have also seen the withdrawal of a Gala, uh, in Europe, so that has accelerated things, for sure. And we have been able to capture a lot of, uh, switch patients as well, and we're only about to launch. Now, in other large markets, we just got the reimbursement in June, in Italy and also, in Spain. So we are ramping up, uh there. Um, so things are going very well in terms of off-label use, uh, PSC. I guess you would allude to because we have shown results. Um, in May at the easel conference, which looked very promising and we are going to discuss these results, uh, with the FDA and potential Way Forward in PSC. Um, but you know, I can't
David Loew: There is a lot of enthusiasm on IQIRVO, and we also have shown new fatigue data. We analyzed the data with proteomics, and we believe the PIPA alpha effect is actually linked to this fatigue effect, which is totally independent from pruritus. So that is also encouraging data. So I am very positive on IQIRVO, I have to say. Thanks a lot for your question.
Really comment on off-label. As you know, we are not promoting it, obviously we can only have scientific exchanges for our MSLs when we get questions. Um, but so far, so good. I mean, there is a lot of enthusiasm on Auro, and we also have shown, um, you know, new fatigue data. We analyze the data with Prognomiq, I have to say.
Operator: Thank you. Just a moment for our next question, please. Next, we have Xian Deng from UBS.
Thank you. Just a moment for our next question, please.
Next, we have S.
Xian Deng: Hey, thank you very much. Thank you for taking that question. Just two, please. The first one on Cabometyx. Now you've got the NET approval in Europe. So just wondering, how should we think about the cadence in the second half? Roughly, when are you thinking to launch? Can you actually launch immediately, given this is actually a drug that's already on market? So we should expect already uptake from Q3, or this is more going to be back and loaded? That's the first question. The second one on Dysport, please. Just wondering, what's the latest underlying trend in aesthetics that you've been seeing? Have you seen any softness in the U.S. from macroeconomics and anything else? Yes, thank you very much.
Hey, thank you very much. Thank you for taking my questions. Um, and, uh, just so please, uh, the first one on a couple metrics. Um, now you've got the net approval in Europe. So just wondering, uh, how should we think about the cadence in the second half? You know, roughly when are you thinking to launch? Can you actually launch immediately given this is actually a drug that's already on the market, so we should expect already uptake from Q3, or is this more going to be um, back-end loaded? So that's the first question. And second one on this course, please, uh, just wondering, uh, you know, what's the latest underlying trends in East?
Have you seen any?
David Loew: Yeah, hi, Xian. Thank you for your questions on Cabometyx. Obviously, we are very enthusiastic now launching into neuroendocrine tumors. This is an area that we know very well, obviously, because we have had a very long legacy with Somatuline in this. We know the KOLs very well. We can launch in Germany, as you know, immediately because you can launch when you have the approval in Europe, in Germany. Then for the other markets, we will have also some payer discussions. It sometimes takes up to 12 months with payers in Europe outside of Germany to actually get the reimbursement. Then we are going to be ready to launch there as well. On Dysport, your question on the trend in aesthetics, we do not really see a softening in the U.S. We see that our partner, Galderma, is doing an excellent job in the U.S.
In the U.S., from, um, you know, macroeconomics and anything else. Um, yeah, thank you very much.
Yeah, hi Sam, thank you for your questions on the carbonetics. Obviously, we're very enthusiastic now. Launching into newer endocrine terms, but this is an area that we know very well, obviously, because we have the very long legacy with Semallon in this. We know the KOLs very well. Um, we can launch in Germany as, you know, immediately because um, you can launch uh,
When you have the approval in Europe, in Germany, and then for the other markets, we will have also some payer discussions. And, you know, it sometimes takes up to 12 months with payers in Europe outside of Germany to actually get the reimbursement, and then we're going to be ready to launch there as well.
David Loew: gaining market share, but also outside of the U.S. gaining market share. We see a similar trend in the territories that we have in aesthetics, where we also see a nice growth. As I said, on Dysport, we expect short, mid, long-term really nice growth in aesthetics, but also in therapeutics. Next question, please.
Um, on this board, uh, your question on the trend in Acts. We don't really see a softening. In the U.S., we see, uh, that our partner is doing an excellent job. Um, in the U.S. gaining market share.
But also outside of the US, gaining market share and we see a similar Trend in the territories that we have in Aesthetics, where we also see a nice growth. So, um, as I said on this word, we expect, um, short mid-, long term, uh, really nice, uh, growth in Aesthetics, but also in Therapeutics
So next question, please.
Operator: Thank you. Just a moment for our next question. Next, we have Victor Flood from BNP Paribas.
Thank you. Just a moment with our next question.
Next, we have Victor Flot from PNP.
Victor Flood: Hey, thanks a lot for taking that question, Victor Flood from BNP Paribas. Maybe first on IQIRVO. I was wondering if you could comment on the potential next step in PSC. I guess it is mainly tied to the IQIRVO IP situation. If so, what are your options to meaningfully extend IQIRVO LOE? If you can do it, what would be the other indication you would be looking at? My second question on the LAMD seq readouts later this year, any chance you could remind us what data you are expecting to share in the second part of the year? I kind of understand it is going to be limited to the stage one. Can you confirm that out of those stage one data, it would be enough to have a clear view on the asset direction of action? Thanks so much.
David Loew: OK, thank you, Victor. On IQIRVO regarding next steps on PSC, as I said, we had presented the data, which was very encouraging, not just on ALP, but also on the fibrosis, which is what you want to see in PSC. We are going to have a discussion with FDA in terms of potential trial design. On IP, as you know, we have orphan drug designation, but there is also a method of use patent. If you would, for example, get an approval in PSC, and since this is a different dose, it is under 20 milligrams, we could also get another orphan drug protection there. This is what we are right now discussing. Regarding the LAMTEC data, I will ask Christelle Huguet to comment.
Hey, thanks for taking that question. Um, maybe first on IQ level, um, I was wondering if you could comment on the potential next step in PSC. Uh, and and I guess it's mainly tied to the IQ of Ip situation. So if so what are your options to meaningfully extend? Auo eloe, and if you can do it, uh, what would be the other indication? You would be looking at. And, and my second question, on, on the Atlantic, read out later this year. Um, any chance you could remind us, what data, uh, you are expecting to share in the second part of the year. So I, I cannot understand it's going to be limited to the stage 1. And so, can you confirm that out of those stage 1 data, it will be enough to have a clear view on the asset duration of action. Thanks so much.
Okay, thank you. Victor on uh, I regarding next steps on PSC. As I said, I mean, we have presented the data which was very encouraging, not just on Alp, but also on the fibrosis, uh, which is what you want to see in PSC. So we are going to have a discussion with FDA in terms of potential trial design. Um, on IP as you know, uh, we have orphan drug designation, but there is also a method of use patterns. So, um, if you would, for example, get an approval in PSC and since this is a different dose, it's on the 20 milligram, we could also get another orphan drug, uh, protection there. And so, this is what we are, uh, right now.
Discussing.
Speaker 8: Thank you, Victor. Yes, indeed, we are reading out the stage one of our LAMTEC study that looks at the safety and efficacy in glabellar lines. This study has a design that includes a follow-up of both our primary and secondary endpoints out to six and nine months. We are very excited to see that data coming, but it is too early to comment on the outcome of the study. You have a design that gives you an idea of what we are really looking for, a differentiation at a longer duration of action that we have built in our study.
Regarding the Atlantic data, I will ask Crystal to comment. Thank you. Uh, Victor. Yes, indeed, we are reading out Stage 1 of our Atlantic study, which looks at the safety and efficacy in the glabella line.
And these studies have a design that includes the follow-up of both our primary and secondary endpoints out to 6 and 9 months. We're very excited to see that data coming, but it's too early to comment on the outcome of the study. However, you have the design that gives you an idea of what we are really looking for: a differentiation as a longer duration of action. We've built in our studies.
David Loew: Understood. Thanks so much.
Victor Flood: Thank you, Victor. Next question.
Operator: Thank you. Just a moment for our next question, please. Next, we have Charles Kings from Barclays. Your line is now open.
Mr. Thanks so much. Thank you, Victor. Next question.
Thank you. Just a moment. So, our next question, please.
Next, we have Charles Kings from Berkeley. Your line is now open.
Victor Flood: Hi, guys. Charles Kings from Barclays. Thanks very much for taking my question. Two focus themes on your neurology portfolio. Firstly, a quick one on Dysport and the therapeutic. Wondering if you could just quantify that phasing impact from Brazil on your therapeutic results. I am just wondering if that should unwind over 2H25 to kind of bring you back in line with that high single-digit flat top-line growth you are targeting. Secondly, as far as the kind of long-acting neurotoxin strategy, can you give us a quick update on what the latest is as far as the arbitration with Galderma is? Thinking maybe just a bit more holistically, what is the kind of long-term goal here?
Victor Flood: Assuming you are successful with the arbitration, do you see value in trying to produce your own distribution network for the aesthetic indications, or would you try and continue to leverage Galderma's distribution network? What are the associated investments that would be required to do that? Just a kind of connection to the investment on LAMT. Can you give us any breakdown of the impact of higher R&D costs in 2H as to why you are expecting a step down in that EBIT margin for the four-year guide? Thank you very much.
Hi guys, Charleston and king from Barkley. Thanks very much for taking my question. Um to focusing just on your your neurology portfolio. Firstly. A quick 1 on Discord and the therapeutic wondering if you could just quantify that phasing impact from Brazil on your therapeutic results I'm just wondering if that should unwind over to H25 to kind of bring you back in line with that high single digit uh flat Topline growth, you're targeting um and then the secondly as far as the kind of um long-acting neurotoxin strategy um can you give us a quick update on what the latest is as far as the arbitration with galderma is? Um, and then thinking maybe just a bit more holistically. What is the look in the long term goal here? Assuming you're successful with the arbitration. Do you see value in trying to produce your own distribution Network for the aesthetic indications? Or would you try and continue to leverage germas distribution Network? Um, you know what the associated Investments That would be required to do that. Um, and just a kind of connection to the investment on on land. Can we just like, can you give us any breakdown of
David Loew: OK, thank you, Charles. Regarding Dysport phasing Brazil, I will let Aymeric elaborate.
The impact of higher R&D costs in 2H as to why you're expecting us to step down on our EBIT margin, um, for the 4-year guide. Thank you very much.
Aymeric Chatelier: Yes, thank you for the questions. I think we are very pleased with the performance that we have in therapeutic, as you know, across the board, including the performance in the U.S. in spasticity, the performance also in Europe. I think the performance was impacted by some shipment phasing that we have with the Ministry of Health in Brazil. We are not going to provide the quantification exactly, but we expect that to stabilize by the end of the year. Overall in therapeutic, we expect Dysport to continue this high single-digit course.
David Loew: On the question of the launch arbitration, we are expecting that the arbitration should read out probably towards the end of the year. We just have to be patient and then see what the arbitration is going to say. I cannot really elaborate on longer-term aesthetics, et cetera, or partnering aspects because we first need to see the arbitration look and then see where we take it from there. Thanks a lot, Charles. Operator, next question.
Okay, thank you. Charles, uh, regarding this board phasing Brazil. I let the American elaborate. Yes, so thank you for the questions. Uh, I think we are very pleased with the performance that we have in in therapy, as you know, um, across the board, including the performance, in the US in specificity, the performance. Also in Europe, I think the the performance was impacted by uh some shipment facing that we have with the Ministry of Health in Brazil. Uh, we're not going to provide the quantification also, exactly. But we expect that, uh, to stabilize by the end of the year, and I think that overall in, uh, therapeutic, we expect this part to continue this. I think a digit goes
And then on the question of the land arbitration, we are expecting that the arbitration should read out. Probably towards the end of the year. So, uh, you know, I we just have to be patient and then, uh, see what the arbitration is going to say. Um, so I can't really, you know, elaborate on longer term, Aesthetics Etc, or partnering aspects because, you know, we first need to see the arbitration act. Uh, look and then and see where we take it from there.
Thanks a lot, Charles operator. Next question.
Operator: Thank you. Just a moment for our next question, please. Next, we have Simon Baker from Redburn Atlantic. Please go ahead.
Thank you. Just a moment for our next question, please.
Next, we have Simon Baker from Roofchild and Co. Redbarn. Please go ahead.
Florent Cespedes: Thank you for taking my questions. I will try and squeeze three in, if I may. Firstly, on Bylvay, I wonder if you could give us some idea of the split of revenues between indications. For IQIRVO, could you remind us how you see the relative size of opportunities in PBC and PSC? As you said, there is no currently approved treatment for PSC. You are probably three or four months ahead of Mirum in PSC. I just wonder how confident you are that you can be first to market and just give us some sort of idea of what would be a reasonable timeline to get to market. The final question was, you mentioned the U.S. share gains for Dysport. I wonder if you could give us a little bit more color on exactly what is behind that and where those are occurring. Thanks so much.
Thank you for taking my questions. Um, I'll try and squeeze 3 in. Um, if I met, um, firstly on Bill. I wonder if you could give us some idea of the, uh, split of revenues between, uh, indications. Uh, and then for, um, a cure vote. Um, could you remind us how you see the relative size of opportunities in PBC and PSC? Um, as you said there is no currently approved treatment for PSC. Um, you're probably well 3 or 4 months ahead of muham, um, in PSC. So I just want to know if how, uh, confident, uh, you are that you can be first to Market and to give us some sort of idea of what would be a reasonable timeline to get to Market. Um, and then the final question was, um, you mentioned the, uh, us uh, share gains.
David Loew: OK, thank you, Simon. On Bylvay, we are not guiding on the split of sales, et cetera, for competitive reasons, obviously. What I can say is that since we launched in PFIC first and Mirum launched in Allergy first, both companies are a bit more dominant in these two indications. We are now launching KAYFANDA in Allergy in the U.S. So we are gaining market share in the U.S., but also we will start to see the effect of the KAYFANDA launch ex-U.S. in the coming months and years. Bylvay is on a really good track. We are going to reinforce also in the U.S. our infield strength to further push the product because we think the product has a really nice potential and we can penetrate even more with some more share of coil.
Four-dice sport. Um, I wonder if you could give us a little bit more color on, um, exactly what's behind that and where those are occurring. Thanks so much.
Okay, thank you, Simon. Um, on the bill, they were not guiding, you know, on the split of sales, etc., for competitive reasons, obviously. But what I can say is that since we launched in P pick first and, uh, Miriam launched in Alisal first.
David Loew: On IQIRVO, regarding your question on the size of PBC and PSC, the PBC market in second line is roughly 40,000 patients. In PSC, the first line indication, because you need to now compare first line, that would be the first product to be used in PSC because there is no other product, you have also 40,000 patients. So the two market sizes are actually fairly similar. I did not quite capture your logic on Mirum developing in PSC because that is not at all the same mechanism of action. We do not see that Mirum would have an effect on fibrosis, which are long-term outcome, which is really what you need to look for, not just pruritus. We do assume that IQIRVO also has a pruritus effect, which you have seen in the phase two data.
With some more Cheryl voice.
On a call regarding your question on the size of PB.
David Loew: Much more importantly, in PSC, you want to see an effect on the fibrosis on the long-term impact on your liver. That is going to, of course, take a bit of time, such a trial. We are going to discuss endpoints with FDA to look at exactly how we would structure that trial. Then we will come back to provide you more details. It is a bit too early to answer this question on timeline. Regarding Dysport and the U.S. market share, what is behind? I would say you should really ask Galderma, of course, if you want to have the details. What I can say is that I think they have done an excellent execution on the launch of Dysport, and Dysport has a very strong perception in the market. So they are gaining market share.
C and PSC. So, the PBC market in the second line is roughly 40,000 patients in PSC. Uh, the first line indication, because you need to now compare first line, that would be the first product to be used in PSC, because there is no other product, you have also for these thousand patients. So, the two market sizes are actually fairly similar. Um, now I didn't quite capture your logic on maram developing in PSC because that's not at all the same mechanism of action. Uh, we don't see that Miriam would have an effect on fibrosis, which, or I, you know, long-term outcome. Which is really what you need to look for. Not just Paris. We do assume that Auro also has a bright effect, which you have seen in the phase 2 data. Um, but much more importantly in PSC, you want to see an effect on the fibrosis on the line?
Long, long-term impact on your liver. So, uh, that's going to, of course, take a bit of time, such a trial. We are going to discuss endpoints, uh, with the FDA to look at exactly how we would structure that trial. That trial, um, and then we will come back, you know, to provide you with more details. So it's a bit too early, uh, to answer this question on the timeline.
Regarding this board and the U.S. market share, what is behind it? I would say, you know, you should really ask Galderma, of course, if you want to have the details. But what I can say is that I think they have done an excellent job in the execution of the launch of Dysport, and Dysport has a very strong perception in the market. So, they are gaining market share.
Florent Cespedes: Great. Thanks so much.
Operator: Thank you. Just a moment for our next question, please. Next, we have Shan Hama from Jefferies. Your line is now open.
Great. Thanks so much.
Thank you.
Just a moment for our next question, please.
Shan Hama: Hi there. Thank you for taking my questions. Two from me please. If I could just push you a little bit on that arbitration. If the resolution isn't favorable to IPSEN, do you think there's scope to renegotiate with Galderma for better financials? Secondly, what's your outlook on ONIVYDE for the rest of the year and even into 2026? It looks like uptake is strained a little bit. Is this because of the physician preference for the original and cheaper regimen, or is it something else that is important for us to note? Thank you.
Next, we have Champs Hammer from Jeffrey's. Your line is now open.
Hi there. Thank you for taking my questions, too. From me, please. If I could just push you a little bit on that arbitration.
So, um, if the resolution isn't favorable to Ipsen, do you think there's scope to renegotiate with GMA for better financials? And then, secondly, what's your outlook on Avide for the rest of the year and even into 2026? Because it looks like the uptick is strained a little bit.
David Loew: Thank you, Xian. On the arbitration, I really cannot comment. As you know, whenever you are in a legal situation, you do not want to speculate on whatever could come out. So I will have to park this for really after the arbitration readout, which should come anyway fairly soon. Then on your second question on ONIVYDE and regarding the longer term, as I said, we recognize that this is a bit of a slower penetration. There is, I would say, a bit of habit with modified FOLFIRINOX, especially in the academic centers. We have been presenting recently real-world effectiveness data, which looked very good and actually very strong. We are also going to start doing more trials in the office space because we want to make sure that we show that also this drug can be used very well in the office space.
Because of the physician preference for the original and cheaper regimen. Or is it something else that, um, is important for us to note? Thank you.
Thank you, shun on on the arbitration. You know, I really can't comment as, you know, whenever you are in a in a legal situation, you don't want to speculate on whatever could come out. So I, I will have to park this for really after the arbitration read out, um, which should come anyway, it's fairly soon and then on your
David Loew: Of course, this is going to take a bit of time. We are also negotiating with payers to take away the hurdles that some of the payers have put in place. We have already had one smaller payer which has lifted this, and we are still negotiating with other payers. So it is going to take time to see the growth. We think it is a bit of a slower growth over time. Thank you for your question.
Second question on onivyde, and regarding the longer term. So we, as I said, we recognize that this is a bit of a slower penetration. Um, there is, I would say, um, a bit of, um, habits, uh, with modified for fear and Ox, especially in the academic centers. We have been presenting recently, real world Effectiveness data, which um, look, very good and actually very strong. We're also going to uh, start doing more trials in the office space because we want to make sure that uh, we show that. Also, this drug can be used very well in the office space. Of course, this is going to take a bit of time and we're also negotiating with payers to take away the hurdles that some of the payers have put in place. Um, we have already had, uh, 1 smaller payer, uh, which Has Lifted, uh, this uh, we are still negotiating with other payers, so it's it's going to take time, uh, you know, to
To see, uh, the growth. So we think it's a bit of a slower growth, uh, over time.
Shan Hama: Thank you.
Thank you very much question.
Operator: Thank you. Next, we have Florent Cespedes from Bernstein. Your line is now open.
Thank you. Thank you.
Next, we have a Florent seed from Burniston. Your line is now open.
Florent Cespedes: Good afternoon. Thank you very much for taking my questions. Two, please. First, on M&A. As your firepower is improving over time, could you maybe elaborate a bit on your strategy? Is there the time to be maybe a bit more ambitious or to look for maybe bigger targets, or are you sticking to your historical strategy? My second question is maybe a follow-up on the LAMTEC trial, just to figure out, could you maybe give a little bit more color about the time frame? I still have the stage two and the stage three. Do you have to understand that it will be first the stage two and then the stage three of the same patients, or is there anything that could be running in parallel? Any color on the time frame would be great. Thank you.
David Loew: Thank you, Florent. Regarding M&A, as you rightly outlined, we have a very significant firepower now. Regarding our ambitions, we will always look for the best science, and then we will make up our mind how we are going to split that firepower. Having said that, we want to continue doing deals over the full spectrum of preclinical, early clinical, late-stage clinical, but also on market. It gives us optionality, obviously, when you have more firepower on what you can do and how many deals you can do. That is actually quite a nice situation to be in. We are, of course, very actively screening for really nice scientific data of companies, and then you will hear more once we have won acquisitions or we have done licensing deals. On LAMTEC, I will hand over to Christelle regarding the design.
Strategy. And my second question is, is maybe a follow-up on the Atlantic uh trial. Uh, just to figure out could you maybe give a little bit more color about the time frame because I still, you have the stage 2 and the stage stage 3. Uh, do you do you, do you have to understand that it will be further stage 2 and then the stage 3, the same patients? Or is there anything that could be running in parallel? Any color on the time frame would be great. Thank you.
Speaker 8: Thank you, Florent, for your question. Indeed, you are right. It is a three-stage study. The stage one, our proof of concept readout, is in glabellar lines. A positive proof of concept from that stage will support a phase three start. While in parallel, the stage two is running in forehead line and lateral canthal line, two other lines of the face. That stage two will be followed by stage three, where we will study the full upper facial line, glabellar line, forehead line, and lateral canthal line. Just to be very specific again, the proof of concept in glabellar line will support a phase three start in glabellar line. The others will come in parallel.
Thank you for, um, regarding m&a. Uh, I mean, uh, as you rightly, I'd like we have a very significant Firepower now, um, regarding our Ambitions. We will always look for the best science and then we will make up our mind how we are going to split that fire power, having said that we want to continue doing deals over the full spectrum of pre-clinical early, clinical late, stage clinical, but also on market and so it gives us optionality. Obviously, when you have more Firepower on what you can do and how many deals you can do. Um, so that's actually quite a nice situation to be in. Um, so we are of course, Very actively screening for really nice scientific, uh, data of companies. And then, uh, you will hear more once. Uh, we have some, you know, 1 1 acquired, we have done licensing deals on lantic. I will uh, hand over to Crystal regarding the design.
So thank you all for your questions. Indeed, you are right, it is a 3-stage study. The Stage 1 is our proof of concept: 3-belt is in the glabella line, and a positive proof of concept from that stage will support a face restart while in parallel. Stage 2 is running in forehead lines and lateral canthal lines, along with other lines of the face.
And that stage, you will be followed by a stage 3 where we will study the full operation line: glabella line, forehead line, and lateral cancer line, which is to be very specific again.
The proof of concept in the glabella line.
Will support a Phase 3 study in the glabella line. The others welcome in parallel.
Florent Cespedes: Thank you very much.
David Loew: Thank you.
Operator: Thank you. I see no further questions at this time. I will now turn the conference back to David Loew, CEO, for closing remarks.
Thank you very much. Thank you.
David Loew: Thank you, everybody, for attending. I hope you have a nice summer break. Thank you.
Thank you. I see no further questions at this time. I will now turn the conference back to our CEO for closing remarks.
Thank you, everybody, for attending, and I hope you have a nice summer break. Thank you.
Operator: Thank you. This concludes the conference call. Thank you for joining. You may now disconnect.
Thank you.
This concludes the conference call. Thank you for joining. You may now disconnect.