Q1 2026 Ipsen SA Earnings Call
David Loew: Thank you, operator, and hello, everyone. I'm pleased to welcome you this afternoon to our Q1 sales presentation, which can also be found on ipsen.com. 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. Please turn to slide three. I'm going to take you through our Q1 sales performance and provide you with a business update, after which our CFO, Aymeric Le Chatelier, will join me for the Q&A session. Let's begin by taking a look at today's highlights. Please turn to slide four. We delivered a strong top-line growth in Q1. Total sales grew by 22.6% this quarter, driven by all three therapeutic areas.
Speaker #1: I'm pleased to welcome you this afternoon to our Q1 sales presentation, which can also be found on ipsen.com. Please turn to slide two. Please take note of our forward-looking statements, which outline the routine risks and uncertainties contained within this presentation.
Speaker #1: Also, all of my comments on growth will be based on constant exchange rates. Please turn to slide three. I'm going to take you through our first-quarter sales performance and provide you with a business update, after which our CFO, Aymeric Chatelier, will join me for the Q&A session.
Speaker #1: Let's begin by taking a look at today's highlights. Please turn to slide four. We delivered strong top-line growth in Q1. Total sales grew by 22.6% this quarter, driven by all three therapeutic areas.
Speaker #1: We're pleased to see the very strong performance of our portfolio outside somatolin, which grew by 27.5% in the three-month period. Based on this continued solid momentum and strong growth, we confirm our 2026 guidance with total sales growth greater than 13% at constant exchange rates, and a core operating margin greater than 35% of sales.
David Loew: We're pleased to see the very strong performance of our portfolio outside Somatuline, which grew by 27.5% in the three-month period. Based on this continued solid momentum and strong growth, we confirm our 2026 guidance with total sales growth greater than 13% at constant exchange rates and the core operating margin greater than 35% of sales. Turning to the pipeline, we were delighted to announce the approval of Kayfanda following the positive CHMP opinion in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma, regardless of BRAF alteration. Looking ahead, 2026 promises to be an exciting year for our pipeline, with several key milestones, including three pivotal Phase 3 readouts expected in H2 2026, as well as the launch of three late-stage programs starting this year. Please turn to slide five. Our Q1 sales delivered solid 22.6% growth, fueled by all three therapeutic areas.
Speaker #1: Turning to the pipeline, we were delighted to announce the approval of Agenda following the positive CHMP opinion in the European Union, as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of.
Speaker #1: Looking ahead, 2026 promises to be an exciting year for our pipeline, with several key milestones, including three pivotal Phase 3 readouts expected in H2 2026, as well as the launch of three late-stage programs starting this year.
Speaker #1: Please turn to slide five. Our Q1 sales delivered solid 22.6% growth, fueled by all three therapeutic areas. The portfolio outside of somatolin grew by 27.5% in the quarter.
David Loew: The portfolio outside of Somatuline grew by 27.5% in the quarter. Oncology performed well with sales up 13%, driven by the strong performance of all products. Rare Diseases continues to stand out, propelled by the sustained performance of Iqirvo and Bylvay. Neuroscience with Dysport delivered 18.5% growth this quarter. I'll now turn to oncology for more detail. Please turn to slide six. Starting with Somatuline, sales were up by 12.8% in Q1. Both the US and Europe continued to benefit from shortages of generic lanreotide in addition to a solid performance in the rest of the world. We do anticipate lanreotide generic competition to resume in H2 2026. Cabometyx sales were up by 16.4% with solid performance in Europe and in the rest of the world. NET launch in Europe continues to progress with additional launches planned this year.
Speaker #1: Oncology performed well, with sales up 13%, driven by the strong performance of all products. Rare disease continues to stand out, propelled by the sustained performance of Acuervo and Bilvey.
Speaker #1: Neuroscience, with this board, delivered 18.5% growth this quarter. I'll now turn to oncology for more detail. Please turn to slide six. Starting with somatolin sales were up by 12.8% in Q1, both the US and Europe continued to benefit from shortages of generic lanreotide in addition to a solid performance in rest of the world.
Speaker #1: We do anticipate lanreotide generic competition to resume in H2 2026. Carbometic sales were up by 16.4%, with solid performance in Europe and in rest of the world.
Speaker #1: NET launch in Europe continues to progress, with additional launches planned this year. Decapeptyl sales were up by 8.4%, as we experienced volume growth in Europe and China.
David Loew: Decapeptyl sales were up by 8.4% as we experienced volume growth in Europe and China, despite continued competition and some pricing pressure in some countries. Now let's turn to rare disease. Please turn to slide seven. In rare disease, Iqirvo continued to track very well, with sales reaching EUR 79 million this quarter. In Q1, we continued to see strong growth in the US. We believe that the switching of Ocaliva patients onto PPARs has now happened and took place mostly during Q4 last year. On the European side, we observe a sustained momentum with more countries coming online and further reimbursements achieved. Turning to Bylvay, we continue to perform well with Q1 sales of EUR 61 million, growing by 51.5%, driven by strong demand in the US, in addition to Europe and some rest-of-world countries such as Japan, where we recently opened a new affiliate.
Speaker #1: Despite continued competition and some pricing pressure in some countries, now let's turn to rare disease. Please turn to slide seven. In rare disease, Acuervo continued to track very well, with sales reaching 79 million euros this quarter.
Speaker #1: In Q1, we continued to see strong growth in the US. We believe that the switching of Ocaliva patients onto PPARS has now happened, and took place mostly during Q4 last year.
Speaker #1: On the European side, we observe a sustained momentum, with more countries coming online and further reimbursements achieved. Turning to Bilvey, we continue to perform well, with Q1 sales of €61 million growing by 51.5%, driven by strong demand in the US, in addition to Europe and some rest-of-world countries such as Japan, where we recently opened a new affiliate.
David Loew: We're also starting to see benefits as the dedicated field force comes fully online in the US. Moving to neuroscience, let's turn to slide 8. Dysport performed very well in aesthetics this quarter, with sales up 24.3%. We have seen continuous growth in most territories, augmented by share gains in some countries. European markets have remained robust. The good performance includes positive phasing of shipments in the rest of the world. In therapeutics, Dysport sales grew by 10.5%, driven by both Europe and the US. This concludes the review of sales. Now let's turn to the pipeline. Please turn to slide 9. We have a well-balanced pipeline across the three therapeutic areas.
Speaker #1: We're also starting to see benefits as the dedicated field force comes fully online in the US. Moving to neuroscience, let's turn to slide eight.
Speaker #1: This board performed very well in Aesthetics this quarter, with sales up 24.3%. We have seen continued growth in most territories, augmented by share gains in some countries.
Speaker #1: European markets have remained robust. The good performance includes positive phasing of shipment in the rest of the world. In therapeutics, this board sales grew by 10.5%, driven by both Europe and the US.
Speaker #1: This concludes the review of sales; now let's turn to the pipeline. Please turn to slide nine. We have a well-balanced pipeline across the three therapeutic areas.
David Loew: I will cover the late-stage assets shortly, but you can see we are building an early to mid-stage pipeline, including several phase I oncology assets and an extensive program across both aesthetics and therapeutics for our long-acting recombinant molecule, IPN10200, now known by its generic name, Corahotase. Please turn to slide 10. Now, I will provide more detail on the key readouts expected in H2 of this year. We have pivotal phase 3 readouts for Dysport in chronic and episodic migraine, Iqirvo in the less severe PBC patients, and Bylvay in biliary atresia. Lastly, further data from our phase 2 LANTIC trial for Corahotase in two additional aesthetics indications of forehead lines and lateral canthal lines. Please turn to slide 11. We're excited to be starting three late-stage trials with a view to registration.
Speaker #1: I will cover the late-stage assets shortly, but you can see we are building an early to mid-stage pipeline, including several phase one oncology assets and an extensive program across both aesthetics and therapeutics for our long-acting recombinant molecule IPN10200, now known by its generic name Corabotase.
Speaker #1: Please turn to slide 10. Now I will provide more detail on the key readouts expected in the second half of this year. We have pivotal phase three readouts for this board in chronic and episodic migraine.
Speaker #1: Acuervo in the less severe PBC patients. Bilvey in biliary atresia. And lastly, further data from our phase 2 LANTIC trial for Corabotase in two additional aesthetics indications: forehead lines and lateral canthal lines.
Speaker #1: Please turn to slide 11. We're excited to be starting three late-stage trials with a view to registration. Following the acquisition of IMCHEC Therapeutics last year, we're initiating activities for the phase two B3 trial in frontline unfit AML.
David Loew: Following the acquisition of ImCheck Therapeutics last year, we're initiating activities for the Phase 2b/3 trial in frontline unfit AML. For Iqirvo, following encouraging Phase 2 data in PSC, we have initiated a Phase 3 trial. Given it is a long-term outcome study, we anticipate the readout in 3 to 4 years. Finally, for the long-acting recombinant molecule, Corahotase, following last year's proof of concept data, we have started the Phase 3 program in glabellar lines, with patients enrolling quickly. The data from the Stage 1 of the Phase 2 LANTIC trial in glabellar lines will be presented at the SCALE symposium in Nashville in May. I would now like to conclude. Ipsen has delivered a strong start to 2026. We are on track to build further momentum in our transformation, and to achieve our objectives for the year.
Speaker #1: For Acuervo, following encouraging phase II data in PSC, we have initiated a phase III trial. Given it is a long-term outcome study, we anticipate the readout in three to four years.
Speaker #1: Finally, for the long-acting recombinant molecule Corabotase, following last year's proof of concept data, we have started the phase three program in Glabella Lines. With patients enrolling quickly, the data from the stage one of the phase two LANTIC trial in Glabella Line will be presented at the scale symposium in Nashville in May.
Speaker #1: I would now like to conclude. It's nice delivered a strong start to 2026. We're on track to build further momentum in our transformation and to achieve our objectives for the year.
David Loew: Our top line continues to deliver, driven by the launches and continued portfolio performance. We're increasing our investment in our launches and our preparations for upcoming launches as we advance our pipeline. To further strengthen our pipeline, we will continue to diligently evaluate external innovations, leveraging our increasing firepower with priorities unchanged. With that, please turn to slide 13. This concludes our presentation, and we will now take your questions. Operator, over to you.
Speaker #1: Our top line continues to deliver driven by the launches and continued portfolio performance. We're increasing our investment in our launches and our preparations for upcoming launches as we advance our pipeline.
Speaker #1: To further strengthen our pipeline, we will continue to diligently evaluate external innovations leveraging our increasing firepower with priorities unchanged. With that, please turn to slide 13.
Speaker #1: This concludes our presentation, and we will now take your questions operator over to you. Thank you. To ask a question, you'll need to press star one and one on your telephone, and wait for your name to be announced.
Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to the first question. One moment, please. Your first question today comes from the line of Yihan Li from Barclays. Please go ahead.
Speaker #1: To withdraw your question, please press star one and one again. We will now go to the first question. One moment, please. And your first question today comes from the line of Yihan Li from Barclays.
Speaker #1: Please go ahead.
Yihan Li: Oh, hey. Congrats on the quarter, and thank you for taking our questions. Yihan Li from Barclays. I guess I have three questions, if I may. The first one is for your ex, the Somatuline business. We saw it is very strong this quarter. Could you please help us to understand how much of that was one-time in nature versus a more sustainable improvement in the base business? With this performance improving across a number of products, what makes you cautious on potentially raising the guidance at this stage? My next question is on Corahotase, the IPN10200. Could you please help us to understand how much the strategic flexibility Ipsen has around the future commercialization in aesthetics? Or more broadly, how should we think about the options to maximize the value of the asset?
Speaker #2: Oh, hey. Congrats on the quarter, and thank you for taking our questions. Yihan Li from Barclays. So, I guess I have three questions, if I may.
Speaker #2: So the first one is for your ex-maturing business. So we saw it is very strong this quarter. So could you please help us to understand how much of that was one-time in nature versus a more sustainable improvement in the base business?
Speaker #2: And with this performance improving across a number of products, so what makes you cautious on potentially recent guidance at this stage? And my next question is on Corabotas, the IPN10200.
Speaker #2: So, could you please help us to understand how much strategic flexibility Ipsen has around the future commercialization in aesthetics? Or, more broadly, how should we think about the options to maximize the value of the asset?
Yihan Li: Is that still possible to collaborate with other companies other than your current Authentics partner? The last one, just wanted to clarify on the timing of Iqirvo Phase 3 data readout in the H2. We saw the primary completion in June. Just curious, are we going to potentially see the data in the Q3? Thank you very much.
Speaker #2: Is it still possible to collaborate with other companies beyond your current aesthetics partner? And lastly, I just wanted to clarify the timing of Acuervo.
Speaker #2: Phase three, data readout in the second half—we saw the primary completion in June. So just curious, are we going to potentially see the data in the third quarter?
Speaker #2: Thank you very much.
David Loew: Okay. Hi, Yihan. Thanks a lot. On Somatuline, we indeed had a strong quarter. This was driven by, of course, the stock outs of the generics. Now, this allowed us to recapture market share volume, obviously through market share, but also price. There is your question on, okay, how much is this a one-time versus sustainable lift? I think we have guided the market to say we expect around Q3, Q4 generics to come back. We know that Amneal has announced yesterday that they plan to intend to launch in Q3. I just want to remind everybody, it's a really hard-to-produce product. You have seen that over the past years, several of the generic producers were struggling, so we have to see how this is going to develop. Therefore, we are a bit cautious on raising the guidance right now.
Speaker #3: Okay. Hi, Yihan. Thanks a lot. On somatoline, we indeed had a strong quarter. This was driven by, of course, the stockouts of the generics.
Speaker #3: Now, this allowed us to recapture market share, volume, obviously, through market share, but also price. So there is a your question on, okay, how much is this a one-time versus a sustainable lift?
Speaker #3: I think we have guided the market to say we expect around Q3, Q4 generics to come back. We know that Amneal has announced yesterday that they plan to intend to launch in Q3.
Speaker #3: I just want to remind everybody, it's a really hard to produce product. You have seen that over the past years, several of the generic producers were struggling.
Speaker #3: So we have to see how this is going to develop. And so therefore, we are a bit cautious on raising the guidance right now.
David Loew: You will have to just be a bit patient, and we have to observe what's going to happen, and that might influence what we're going to tell the market. On the Corahotase, we have strategic flexibility. The arbitration was clear. We fully own the product. We are not going to elaborate now on what we are going to do in terms of partnering or not. I just want to remind you that we're also still in those filings in some of the indication in aesthetics with FHL and LCL, as I said, where we're going to show results towards the end of the year. Also in the therapeutic space, we also have still the dose finding. To your third question on Iqirvo in phase 3, we are going to unblind this summer.
Speaker #3: So you will have to just be a bit patient, and we have to observe what's going to happen. And that might influence what we're going to tell the market.
Speaker #3: On the Corabotas, we have strategic flexibility. The arbitration was clear. We fully own the product. We are not going to elaborate now on what we are going to do in terms of partnering or not.
Speaker #3: I just want to remind you that we're also still in those findings in some of the indication in aesthetics with FHL and LCL, as I said, where we're going to show results towards the end of the year.
Speaker #3: And then also in the therapeutic space, we also have still the dose finding. And to your third question on Acuervo in phase three, so we are going to unblind this summer.
David Loew: Indeed, as you say, we assume that we would submit the data to AASLD, which is, I think, in Q4, if I recall it right, in November. You will probably see a press release when we unblind, and then you're going to see the data towards the end of the year. Thank you.
Speaker #3: Indeed, as you say, we assume that we would submit the data to ASLD, which is, I think, in Q4, if I recall it right, in November.
Speaker #3: So you will probably see a press release when we unblind. And then you're going to see the data towards the end of the year.
Speaker #3: Thank you.
Yihan Li: Thank you. Sorry, I just wanted to clarify on my first question. I think I was asking about the business outside of Somatuline treating. What is the one-time nature versus sustainable improvement?
Speaker #2: Thank you. So, I just wanted to clarify on my first question. I think I was asking about the business outside of Somatoline. So, what is one-time in nature versus sustainable improvement?
David Loew: When you-
Speaker #3: Well, when you have an increase in sales and we have seen that the market is growing, we have taken back market share. Of course, if you get affected by generics, that will have that effect of the lift that you come from a higher level will have a carry-forward effect.
Yihan Li: Thank you.
David Loew: We have an increase in sales, and we have seen that the market is growing. We have taken back market share. Of course, if you get affected by generics, that will have that effect of the lift that you come from a higher level. It will have a carry forward effect we have to assume. There is a carry forward on this beneficial effect.
Speaker #3: We have to assume. So there is partially there is a carry-forward on this beneficial effect.
Yihan Li: Thank you.
Speaker #2: Thank you.
David Loew: Next question.
Speaker #3: Next question.
Operator: Thank you. Your next question comes from the line of Xian Deng from UBS. Please go ahead. Xian, is your line muted?
Speaker #1: Thank you. Your next question comes from the line of Shayan Deng from UBS. Please go ahead. Shayan, is your line muted?
Xian Deng: Oh, hi. Can you hear me now?
Speaker #4: Oh, okay. Can you hear me now?
David Loew: Yes, we can hear you.
Speaker #3: Yes, we can hear you.
Xian Deng: Thank you. Xian from UBS. Thank you for taking my questions. Two please. First, both on Bylvay. First one is Bylvay did really, really well this quarter with EUR 16 million growth from Q4 2025. Just wondering, is this rate of growth something that we can expect for the rest of the year, or do you think this will more sort of stabilize a bit? The second one is the phase 3 readout for Bylvay in BA. Just wondering if you could comment on your thoughts on the probability of success and commercial opportunity here. That would be great. Sorry if I can maybe just squeeze one in quickly, kind of a follow-up from the previous question. Decapeptyl and Dysport. You got a bit of positive phasing for Q1. Just wondering if you could maybe quantify the size of positive phasing, please.
Speaker #4: Thank you. Shian from UBS, thank you for taking my questions. So two, please. So first, both on Belvi. So first one is Belvi did really, really well this quarter with 16 million euro growth from Q4 2025.
Speaker #4: So just wondering if this rate of growth is something that we can expect for the rest of the year, or do you think this will more sort of stabilize a bit?
Speaker #4: And then the second one is the phase three readout for Belvi in BA. So just wondering if you could comment on your thoughts on the probability of success and commercial opportunity here, that would be great.
Speaker #4: Sorry, if I can maybe just squeeze one in quickly. Kind of a follow-up from the previous question. So, Deca Pepto and this board—you got a bit of positive facing for Q1.
Speaker #4: Just wondering if you could maybe quantify the size of positive facing, please. Thank you.
Xian Deng: Thank you.
David Loew: Thank you, Xian. On Bylvay growth, we are very pleased obviously with the dynamics. As you have heard us say, we have a dedicated field force that we have put in place in September last year. The rollout started and so clearly it does have an effect. Now, it's a bit early days to say, okay, is that going to totally change the trajectory or was there a bit of a catch-up on some of the patients? I think we have to observe that. We are definitely very pleased with the dynamics of the drug. On the phase 3 on biliary atresia, I mean, as you know, the hurdle is relatively high on biliary atresia because we have a very hard endpoint on liver transplant.
Speaker #5: Thank you, Shian. So on Belvi growth, we are very pleased, obviously, with the dynamic. As you have heard us say, we have a dedicated field force that we have put in place.
Speaker #5: In September last year, so the rollout started. And so clearly, it does have an effect. Now, it's a bit early day to say, okay, is that going to totally change the trajectory, or was there a bit of a catch-up on some of the patients?
Speaker #5: So I think we have to observe that, but we are definitely very pleased with the dynamic of the drug. On the phase three, on biliary atresia, I mean, as you know, the hurdle is relatively high on biliary atresia.
Speaker #5: Because we have a very hard-end point on liver transplant. And so therefore, we will have to see the children need to have a quasi-procedure.
David Loew: Therefore we will have to see that the children need to have a Kasai procedure and sometimes the liver functions properly after this Kasai procedure, sometimes it doesn't fully function. This is also why the hurdle on BA is relatively high. The commercial opportunity that we have guided is about as big as PFIC and Alagille together. It's a significant upside if we hit it. Then on your third question on Decapeptyl and Dysport phasing, I'll let Aymeric comment.
Speaker #5: And sometimes the liver functions properly after this quasi-procedure. Sometimes it doesn't fully function. So this is also why the hurdle on BA is relatively high.
Speaker #5: The commercial opportunity that we have guided is about as big as PFIC and ELEGIBLE together. So, is this significant upside if we hit it?
Speaker #5: And then on your third question on Deca Pepto and this board phasing, I'll let Aymeric comment.
Aymeric Le Chatelier: Yeah. Thank you, David. Thank you for the question. Yes, it is true to acknowledge that the performance of Decapeptyl, as you can see, has been boosted, especially in the rest of the world by some extra shipment, especially related to supplying the Middle East markets. I think you should not expect the rest of the world to continue to grow at a very strong double-digit, while at the same time the product is doing very well, including in China. Regarding Dysport, you have the same effect on the aesthetic sales where you see that we are growing by 35%. This is also based on very high level of shipment for the quarter. Having said that, we also are very happy with the performance both of Galderma and on the Ipsen territory for also the world of Dysport.
Speaker #6: Yeah, so thank you, David. Thank you for the question. Yes, it is true to acknowledge that the performance of Deca Peptyl, as you can see has been boosted, especially in the rest of the world, by some extra shipment, especially related to supplying the Middle East markets.
Speaker #6: So I think you should not expect the rest of the world to continue to grow at a very strong double digit. While at the same time, the product is doing very well, including in China.
Speaker #6: Regarding this board, you have the same effect on the aesthetic sales, where you see that we are growing by 35%. This is also based on a very high level of shipment for the quarter.
Speaker #6: Having said that, we also are very happy with the performance both of Galderma and on the IPSEN territory for the rest of the world of this board.
Xian Deng: Thank you.
David Loew: Thank you. Operator, next question, please.
Speaker #4: Thank you.
Speaker #3: Thank you, operating on the next question, please.
Operator: Thank you. Your next question comes from the line of Sophia Kjaergaard Nielsen from J.P. Morgan. Please go ahead.
Speaker #1: Thank you. Your next question comes from the line of Sophia Graf Pohl Nielsen from JP Morgan. Please go ahead.
Sophia Kjaergaard Nielsen: Good afternoon. Thanks for taking the questions. Could you talk about how you see the growth potential of Iqirvo going forward now that the impact of the Ocaliva withdrawal is largely behind us? In H2, we have the phase 3 ELSPYRE study in second-line PBC patients with lower ALP coming up. Just how are you thinking about the market expansion opportunity for this and the potential for Iqirvo from this trial? Is there any use of the product already in these patients? Just also any additional color you could share in terms of market share developments for Dysport and aesthetics in Europe would be great.
Speaker #7: Good afternoon. Thanks for taking the questions. Could you talk about how you see the growth potential of Icuivo going forward now the impact of the Ocalivo withdrawal is largely behind us?
Speaker #7: In the second half, we have the phase three Elspire study in second line PBC patients with lower ALP coming up. Just how are you thinking about the market expansion opportunity for this?
Speaker #7: And the potential for Icuivo from this trial? Is there any use of the product already in these patients? And then just also any additional color you could share in terms of market share developments.
Speaker #7: So diaspora and aesthetics in Europe would be great.
David Loew: Okay. Thank you, Sophia. Taking your first question on Iqirvo, what's going to be the dynamic now that Ocaliva withdrawal has basically washed out? What you have observed is that we had a very nice growth in Q1 to, let's say, middle of Q3. Then Ocaliva was withdrawn and Q4 was a notable significant acceleration. What you should think of looking forward now is that the growth which we are going to see from, let's say Q2 to Q4, is going to be probably around the speed that you have seen at Q1 to Q3 last year. Because this jump that we have done on Q4 has lifted up on the next level, on a much higher level. And of course, we're going to continue growing on this higher level. That is probably how you need to think about it.
Speaker #3: Okay. Thank you, Sophia. So taking your first question on Accuravo, what's going to be the dynamic now that Ocalivo withdrawal has basically washed out?
Speaker #3: So what you have observed is that we had a very nice growth in Q1 to, let's say, middle of Q3. And then Ocalivo was withdrawn, and Q4 was a notable significant acceleration.
Speaker #3: So, what you should think of looking forward now is that the growth which we are going to see from, let's say, Q2 to Q4 is going to be probably around the speed that you have seen at Q1 to Q3 last year.
Speaker #3: Because this jump that we have done on Q4 has lifted up on the next level, on a much higher level. And of course, we're going to continue growing on this higher level.
Speaker #3: So that is probably how you need to think about it. And then, on top of it, comes the unblinding of Elspire. So what I was just saying on the growth rates was just relating to the above 1.67.
David Loew: Then comes on top of it, the unblinding of ELSPYRE. What I was just saying on the growth rates was just relating to the above 1.67. Now, if you now assume that we would have a positive readout of ELSPYRE in the below 1.67, that would give an additional lift. Just to give you a bit of an idea in terms of the size of the pools that we have in these different population. When you take the US, PBC overall are about 100,000 patients. Out of which in second line then, in the above 1.67, we estimate to have about 30,000 patients, and in the below 1.67, you have about 20,000 patients. It's a sizable business opportunity, adding to the 30,000 where we can be used 20,000 on top of it.
Speaker #3: Now, if you now assume that we would have a positive readout of Elspire in the below 1.67, that would give an additional lift. Just to give you a bit of an idea in terms of the size of the pools that we have in these different populations, so when you take the US, PBC overall are about 100,000 patients.
Speaker #3: Out of which, in second line then, in the above 1.67, we estimate to have about 30,000 patients. And in the below 1.67, you have about 20,000 patients.
Speaker #3: So, it's a sizable business opportunity, adding to the 30,000 where we can be used—20,000 on top of it. Now, some of those are potentially not going to be eligible because they're very close to one.
David Loew: Now, some of those are potentially not going to be eligible because they're very close to 1, but there is a good part of the patients that are eligible there, and they also sometimes have symptoms despite being below 1.67. It therefore constitutes a clear market expansion opportunity. We do see and we estimate that on our current sales, we have about 20% of the scripts coming from the below 1.67 already, so there is already some use there. The ELSPYRE trial is really going to turbo boost the penetration in the below 1.67 because it's going to add data. To help you, we don't need to wait until we would have a label update because the label is actually not restricted to the above 1.67.
Speaker #3: But there is a good part of the patients that are eligible there, and they also sometimes have symptoms despite being below 1.67. And it therefore constitutes a clear market expansion opportunity.
Speaker #3: We do see and we estimate that on our current sales, we have about 20% of the scripts coming from the below 1.67 already. So there is already some use there.
Speaker #3: So the Elspire trial is really going to turbo boost the penetration in the below 1.67 because it's going to add data to help you we don't need to wait until we would have a label update because the label is actually not restricted to the above 1.67.
David Loew: This is why you see already some use in the below 1.67, despite the fact that the people didn't have data yet. Both companies are going to show data, and that's probably going to significantly enlarge the market because with data in hand, physicians are probably going to increase the use in a significant manner in the below 1.67. To the market share question, if I understood right, Dysport, I let Aymeric answer.
Speaker #3: So this is why you see already some use in the below 1.67, despite the fact that the PPARS didn't have data yet. Both companies are going to show data.
Speaker #3: And that's probably going to significantly enlarge the market because, with data in hand, physicians are probably going to increase the use in a significant manner in the below 1.67.
Speaker #3: And then to the market share question, if I understood it right, this board AX, I'll let Aymeric answer.
Aymeric Le Chatelier: Yes. Thank you, David. Regarding the question on market share, I think you should ask our partner Galderma. We are not commenting on market share. What you can see is that we are very pleased with the performance of Dysport in aesthetic in Europe growing by 9.5% this quarter, and we expect that to continue for the year.
Speaker #6: Yeah, so thank you, David. So regarding that question on market share, I think you should ask our partner Galderma. We are not commenting on market share.
Speaker #6: What you can see is that we are very pleased with the performance of this board in aesthetic in Europe, growing by 9.5% this quarter.
Speaker #6: And we expect that to continue for the year.
Sophia Kjaergaard Nielsen: Thank you.
Speaker #7: Thank you.
Operator: Thank you. Your next question comes from the line of Victor Floc'h from BNP Paribas. Please go ahead.
Speaker #1: Thank you. Your next question comes from the line of Victor Floch from BNP Paribas. Please go ahead.
Victor Floc'h: Hey, thanks very much for taking my question, Victor Floc'h from BNP Paribas. Maybe first one on Iqirvo. I think in the past you have been strictly pointing out to a base case LOE around 2031. If I'm not mistaken, there is a large family of patents that could extend the IP protection of Iqirvo. Any chance you could discuss the different options you have and whether we could expect formative data on this at some point? My second question is on Somatuline. I think Amneal said yesterday that they were actually asked by the FDA to accelerate the review of their filings.
Speaker #3: Hey, thanks very much for taking my question, Victor Floch, BNP Paribas. Maybe first one on Icuivo. I think in the past, you have historically pointed out to a base case LOE around 2031.
Speaker #3: But if I'm not mistaken, there is a large family of patents that could extend the IP protection of Icuivo. So any chance you could discuss the different options you have and whether we could expect a formal update on this at some point?
Speaker #3: And my second question is on Osomatulin. So I think on Amnil, I've said yesterday that they were actually asked the FDA to accelerate the review of their filing.
Victor Floc'h: Just wondering whether you think that the Q3 is still a reasonable timing for a potential entry and also whether we should assume that the long-term contracting that you have in the US should also be helpful when it comes to protect your market share in this market. Thanks so much.
Speaker #3: So, just wondering whether you think that the Q3 is still a reasonable timing for a potential entry. And also, whether we should assume that the long-term contracting that you have in the US should also be helpful when it comes to protecting your market share in this market.
David Loew: Yeah. Thank you, Victor Floc'h. On Iqirvo, as you have seen from our URD document, we have the base patent expiring in 2031, but there are method of use patents which indeed can go significantly longer. We are not expressing ourselves as a company on what our assumption is. I think you have to make your own decisions here. What I can say, in addition, is that if we would hit it in primary sclerosing cholangitis, we would launch the drug, elafibranor, under a different brand name. Given that it's a different dosing and given that the tablets are not split tablets, we assume that the generics are not going to penetrate there on PSC, and we have orphan drug protection, so you would have an additional 7 years on top of this for the PSC indication. On Somatuline.
Speaker #3: Thanks so much. Yeah, thank you, Victor. So on Accuravo, as you have seen from our UDR document, we have the base patent expiring in 2031.
Speaker #3: But there are methods of use patents which indeed can go significantly longer. So we are not expressing ourselves as a company on what our assumption is.
Speaker #3: I think you have to make your own decisions here. What I can say, in addition, is that if we would hit it in primary sclerosing colonitis, we would launch the drug Elafibenor under a different brand name given that it's a different dosing and given that the tablets are not split tablets.
Speaker #3: We assume that the generics are not going to penetrate there on PSC. And we have orphan drug protection. So you would have, in additional seven years on top of this for the PSC indication.
Speaker #3: Then, on somatinin—I mean, Amnil asking the FDA to accelerate. You have seen the FDA stating that they want to accelerate some drugs, but I don't think that they talked about generics.
David Loew: I mean, Amneal asking FDA to accelerate, you have seen the FDA stating that they want to accelerate some drugs, but I don't think that they talked about generics. I mean, they have talked about some real breakthrough drugs, like when you have massive overall survival benefits with a new drug, et cetera. I mean, that was basically the discussion. I would certainly not assume that they would come any time earlier than what they have said. They have also a little bit of a track record of having delays. As you know, they gave originally the date of Q1, then they pushed it out to Q2, and then they said in Q2, now it's Q3. Let's see what's going to happen there. To your question then, on the long-term contracts, of course, we're not going to comment on what our strategy is.
Speaker #3: I mean, they have talked about some real breakthrough drugs. Like when you have massive overall survival benefits with a new drug, et cetera. I mean, that was basically the discussion.
Speaker #3: So I would certainly not assume that they would come anytime earlier than what they have said. They have also a little bit of a track record of having delays.
Speaker #3: As you know, I mean, they gave originally the date of Q1. Then they pushed it out to Q2. And then they said in Q2, now it's Q3.
Speaker #3: So, let's see what's going to happen there. To your question then, on the long-term contracts—I mean, of course, we're not going to comment on what our strategy is.
David Loew: You have to make your assumptions here yourself. Thank you.
Speaker #3: So you have to make your assumptions here yourself. Thank you.
Victor Floc'h: Thank you very much.
Speaker #1: Thank you very much.
Operator: Thank you. As a reminder, if you would like to ask a question, please press star one and one on your telephone keypad. That is star one and one to ask a question. We'll now go to our next question. The next question comes from the line of Charlie Hayward from Bank of America. Please go ahead.
Speaker #2: Thank you. As a reminder, if you would like to ask a question, please press star 1 and 1 on your telephone keypad. That is star 1 and 1 to ask a question.
Speaker #2: We'll now go to our next question. And the next question comes from the line of Charlie Haywood from Bank of America. Please go ahead.
Charlie Hayward: Hi, Charlie Hayward, Bank of America. I have three questions, please. The first is just on the potential to commercialize IPN10200 alone, which I know is an option for you and obviously would be a significant strategic decision. If you were to go it alone, how do you think about your ability to compete commercially and the feasibility of scaling up that sales force? And then any sort of magnitude or phasing of costs to ramp that up. Second question on sort of Galderma recent commentary, post the arbitration, there looks to be a slight sort of discrepancy in who has the rights to the commercialization. I guess any color on that from your side or if it's been clarified with the party. And would there be a potential need for another arbitration down the line to resolve that issue?
Speaker #8: Hi, Charlie Haywood, Bank of America. I have three questions, please. So the first is just on the potential to commercialize 10, 200 alone, which I know is an option for you.
Speaker #8: And obviously, it would be a significant strategic decision. So if you were to go into loan, how do you think about your ability to compete commercially and the feasibility of scaling up that sales force?
Speaker #8: And then, any sort of magnitude or phasing of costs to ramp that up? Second question, on sort of Galderma's recent commentary post the arbitration—there looks to be a slight sort of discrepancy in who has the right to the commercialization.
Speaker #8: I guess, any color on that from your side, or if it’s been clarified with the party? And would there be a potential need for another arbitration down the line to resolve that issue?
Charlie Hayward: Third question, if we only see 1 SOMA generic in 2027, and let's say we assume it's Amneal, how should we broadly think about the Somatuline outlook for 2027? It feels like 1 generic would not be your sort of mid-teen to 20% annual decline needed for 2 to 3 generics. Is that close to sort of flat, slight decline? Is that fair or how should we think of a good proxy there? Thank you.
Speaker #8: And then, third question: if we only see one SOMA generic in '27, and let's say we assume it's Amnil, how should we broadly think about the Somatulin outlook for '27?
Speaker #8: It feels like one generic would not be your sort of mid-teens 20% annual decline needed for two to three generics. So is that closer to sort of flat, slight decline?
Speaker #8: Is that fair? Or how should we think of a good proxy there? Thank you.
David Loew: Okay. I start with your first question on IPN10200, which we now call Corahotase. It has a generic name. We don't need to remember any fancy figures anymore, so it's Corahotase. On our go-to-market strategy, we're evaluating all scenarios. We're not going to comment on what we are going to do. As I said, we're also still in the dose finding on some of the aesthetic indications, but also on the therapeutic indications, and we also want to see more data. Of course, we could choose to invest ourselves. We have what is needed. As I said, this is something that we have to carefully evaluate in the light of what I just said before. Regarding the legal statements, I do not comment on legal statements from Galderma. What I can tell you is that the arbitration was very clear.
Speaker #3: OK, so I'll start with your first question on IP and 10, 200, which we now call Corabotes. So it has a generic name. We don't need to remember any fancy figures anymore.
Speaker #3: So it's Corabotes. And on our go-to market strategy, I mean, we're evaluating all scenarios. So we're not going to comment on what we are going to do.
Speaker #3: So, as I said, we're also still in the dose finding on some of the aesthetic indications, but also on the therapeutic indications. And we also want to see more data.
Speaker #3: Of course, we could choose to invest ourselves. I mean, we have what is needed. But as I said, I mean, this is something that we have to carefully evaluate in the light of what I just said before.
Speaker #3: Regarding the legal statements, I do not comment on legal statements from Galderma. What I can tell you is that the arbitration was very clear.
David Loew: We have full rights on Corahotase ourselves. On the third one, I hand over to Aymeric.
Speaker #3: We have full rights on Corabotes ourselves. And then on the third one, I hand over to Aymeric.
Aymeric Le Chatelier: Yeah. Thank you, David. Regarding the potential impact, if there were to be only one generic to launch by the end of this year, I think we should anticipate that there will be an impact on 2027, especially given the very strong baseline for 2026. Having said that, we're not going to provide the guidance today. Just reminding you that only one generic will be a progressive erosion, as we characterize it in the past. It's only if we see more than one that we see a potentially more accelerated erosion for Somatuline. Let's wait and see what's happened, as David said, regarding a first generic to be able to launch, because this is still a challenging space for companies to manufacture and to secure approval, both in the US and also outside the US.
Speaker #4: Yeah, so thank you, David. So regarding the potential impact, if they were to be only one generic to launch by the end of this year, I think you should anticipate that there will be an impact on 2027, especially given the very strong baseline for 2026.
Speaker #4: As in said that, we're not going to provide the guidance today just reminding you that only one generic will be a progressive erosion as we characterize it in the past.
Speaker #4: It's only if we see more than one that we see a potentially more accelerated erosion for Somatinlin. So let's wait and see what's happened as David said regarding a first generic to be able to launch.
Speaker #4: Because this is still a challenging space for companies. To manufacture and to secure approval both in the US and also outside the US.
David Loew: Let's perhaps just to add something to remember. It's an Autogel, which needs to have the right viscosity. If it's too viscous, you can't push it through the syringe. If it's not viscous enough, you have leakage of syringes. We have also observed that some of the generic producer had some air bubbles in there, et cetera. The yields that you get and the compliance of the product, et cetera, the quality controls that you need to do has been an issue as testimonies by the several 483s and then OAI. Pharma 10 got an OAI and some pharma as well. It's not really an easy product to produce. The next question.
Speaker #3: And let's perhaps just add something to remember. It's an autogel, which needs to have the right viscosity. If it's too viscous, you can't push it through the syringe.
Speaker #3: If it's not viscous enough, you have leaky syringes. And we have also observed that some of the generic producer had some air bubbles in there, et cetera.
Speaker #3: So the yield that you get and the compliance of the product, et cetera, the quality controls that you need to do has been an issue as testimonied by the several 483s and then OAI, so pharma 10 got an OAI and some pharma as well.
Speaker #3: So it's not really an easy product to produce. The next question.
Operator: Thank you. Your next question comes from the line of Simon Baker from Rothschild & Co. Please go ahead.
Speaker #2: Thank you. Your next question comes from the line of Simon Baker from Rothschild and Co. Please go ahead.
Keith Dean: Hi, this is Keith Dean speaking, for Simon. I have two questions. The first one is on Bylvay. Is the Bylvay sales force change complete or is there more to come? And my second question is on the 10200. What's the overall appetite for the long-acting toxin based on your discussion with prescribers? And does that differ between aesthetics and therapeutics? Thank you.
Speaker #5: Hi, this is Akisa Dean speaking. For Simon, I have two questions. The first one is on Belvey. So is the Belvey Salesforce change complete, or is there more to come?
Speaker #5: And my second question is on the 10, 200. So what's the overall appetite for the long-acting toxin based on your discussion with prescribers? And does that differ from between aesthetics and therapeutics?
Speaker #5: Thank you.
David Loew: Okay. I didn't quite get your second question. Can you just repeat this?
Speaker #3: OK, I didn't quite get your second question. Can you just repeat this?
Keith Dean: Yeah. Sure. No problem. Regarding the 10200, what's the overall appetite for the long-acting toxin based on your discussion with prescribers, and does that differ between the aesthetics and therapeutics?
Speaker #5: Yeah, yeah, sure. No problem. So, regarding the 10, 200, what's the overall appetite for the long-acting toxin, based on your discussion with prescribers? And does that differ between the aesthetics and the therapeutics?
David Loew: Okay. Yeah. Great. Thank you. Okay. On Bylvay, yes, I can say the field force implementation is complete. They have been deployed last autumn. Now they're going out in the field, and we clearly see the first effects. We're very pleased with that. On 10,200, as I said, it's called Corahotase now. We see a very high interest for that drug on both the aesthetics and the therapeutics. As I said, we have started the phase 3 glabellar line trial, and it's recruiting extremely fast. The investigators are enthusiastic, and you're going to see the data at the conference in May. We're probably also going to have an IR event at that time. The same feedback we're getting in the therapeutics.
Speaker #3: OK, yeah, great. Thank you. OK, so on Belvey, yes, I can say the field force implementation is complete. So they have been deployed last autumn.
Speaker #3: So now they're going on the field and we clearly see the first effects. So we're very pleased with that. On 10, 200, as I said, it's called Corabotes now.
Speaker #3: We see a very very high interest for that drug. On both the aesthetics and the therapeutics, as I said, we have started the phase three glabella line trial.
Speaker #3: And it's recruiting extremely fast. The investigators are enthusiastic. And you're going to see the data at the conference in May. We're probably also going to have an IR event at that time.
Speaker #3: And the same feedback we're getting in the therapeutics. I mean, that's a real game changer in therapeutics because for example, if you're a migraine patient, or cervical dystonia, or spasticity patient, if you do only inject every six months instead of every three months, that makes a massive difference, A, for the patient, B, for the physician, because there are not that many physicians which know how to inject.
David Loew: That's a real game changer in therapeutics because, for example, if you're a migraine patient or cervical dystonia or spasticity patient, if you do only inject every six months instead of every three months, that makes a massive difference, A, for the patient, B, for the physician, because there are not that many physicians which know how to inject. It requires a very specific know-how how to inject. It's complex to get trained and to do this procedure. It's going to unlock a lot of additional capacity in the healthcare system, and it's going to make the healthcare system more effective. For payers, this is also a very interesting new option. I think this can be a drug which is really significantly changing Ipsen if everything works out as we want to. I'm very excited about this drug.
Speaker #3: It requires very specific know-how how to inject. It's complex to get trained. And to do this procedure. So it's going to unlock a lot of additional capacity in the health care system.
Speaker #3: And it's going to make the health care system more effective. So for payers, this is also a very interesting new option. So I think this can be a drug which is really significantly changing Ipsen, if everything works out as we want to.
Speaker #3: So I'm very, very excited about this drug.
Keith Dean: Thank you.
David Loew: I think, operator, that was our last question. Correct?
Speaker #5: Thank you.
Speaker #3: And I think operator, that was our last question. Correct?
Operator: That is correct, sir. Back to you now.
Speaker #2: That is correct, sir. Back to you now.
David Loew: Okay. That wraps up our Q1 results conference. Thank you for having participated. Bye-bye.
Speaker #3: OK, that wraps up our Q1 results conference. Thank you for having participated. Bye-bye.
Operator: Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.
