Ipsen Sa S/Adr

Hello and welcome to Ibsen's conference call and webcast on Q1 2026 results. I'll now hand you over to David Lowe, Ibsen's CEO.

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 Ibsen.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 first quarter 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. 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. 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 BRAF alteration. Looking ahead, 2026 promises to be an exciting year for our pipeline, with several key milestones, including three pivotal phase three 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. The portfolio outside of somatoling grew by 27.5% in the quarter. 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 Aquervo and Bilvay. 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. We do anticipate Lanoitai generic competition to resume in H2 2026. Cobometic 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. Decapeptil 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, iQurvo continued to track very well with sales reaching 79 million euros this quarter. In Q1, we continue to see strong growth in the US. We believe that the switching of our Caliva 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 Bilvey, we continue to perform well with Q1 sales of 61 million euros, 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. 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. The sport 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 shipment in the rest of the world. In therapeutics, the sport 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 nine. We have a well-balanced pipeline across the three therapeutic areas. 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, Corobotase. 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 Dysport in chronic and episodic migraine, IQIRVO in the less severe PBC patients, BILVE in biliary atresia. And lastly, further data from our phase two LANTIC trial for chorobotase 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. Following the acquisition of Imcheck Therapeutics last year, we're initiating activities for the Phase 2b3 trial in frontline unfit AML. For Equivalent, following encouraging Phase 2 data in PSC, we have initiated the Phase 3 trial. Given it is a long-term outcome study, we anticipate the readout in three to four years. Finally, for the long-acting recombinant molecule, Corabotase, 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 Lantik trial in glabellar line will be presented at the SCALE Symposium in Nashville in May. I would now like to conclude. ICSN 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. 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.

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. 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. Please go ahead.

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. So the first one is for your X, the maturing business. So we saw it is very strong this quarter. So could you please help us to understand know how much of that was one time in nature versus a most sustainable improvement in the base business and with this performance improving across a number of products so what makes you cautious on potentially reaching the guidance at this stage and my next question is on cover botis the ipn 10 200 So could you please help us to understand, you know, how much the strategic flexibility Epson has around the future commercialization in Authentics? Or more broadly, how should we think about the options to maximize the value of the asset? Is that still possible to collaborate with other companies other than your current Authentics partner? And the last one, just wanted to clarify on the timing of Equivalent. phase three data readout in the signal hub, we saw the primary completion in June. So just curious, are we going to potentially see the data in the third quarter? Thank you very much.

OK. Hi, Yihan. Thanks a lot. On somatolin, 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. So 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 Omnial 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 gonna develop and so therefore we are a bit cautious on raising the guidance right now 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. On the Corobotes, 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 dose 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. And then also in the therapeutic space, we also have still the dose findings. And your third question on ICOBO in phase three is, So we are going to unblind this summer. 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. 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. Thank you.

Thank you. So I just wanted to clarify on my first question. I think I was asking. about the business outside of summer cooling. So what is the one-time image versus sustainable improvement?

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, we have to assume. So there is partially, there is a carry-forward on this beneficial effect.

Thank you. Next question.

Thank you. Your next question comes from the line of Cheyenne Deng from UBS.

Please go ahead. Cheyenne, is your line muted?

Oh, hi. Can you hear me now?

Yes, we can hear.

Thank you. 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. So 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? And then the second one is the phase three radar for Bellevue in BA. So just wondering if you could comment on, you know, 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. So DECA PEPTO and this board, You've got a bit of positive facing for Q1. Just wondering if you could maybe quantify the size of positive facing, please. Thank you.

Thank you, Yuxiang. So on Bill May 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 in September last year. So the role I started. And so clearly it does have an effect. Now, it's a bit early day, you know, 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? 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 because we have a very hard end point on liver transplants. And so therefore, we will have to see that the children need to have a CASI procedure and, you know, sometimes deliver functions properly after this CASI procedure. Sometimes it doesn't fully function. So this is also why the hurdle on VA is relatively high. The commercial opportunity that we have guided is about as big as PFIC and Alagile together. So it's a significant upside if we hit it. And then on your third question on decapeptyl and disport phasing, I'll let Emeric comment.

Yes, so 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. 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. Regarding this port, you have the same effect on the aesthetic sales, where you see that we are going 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 Ibsen territory for also the world of this port.

Thank you.

Thank you. Operator, next question, please.

Thank you. Your next question comes from the line of Sophia Graf Paul-Nielsen from JP Morgan. Please go ahead.

Good afternoon. Thanks for taking the questions. Could you talk about how you see the growth potential of IQVO going forward now the impact of the Oculeva withdrawal is largely behind us? In the second half, we have the Phase 3 L-SPIRE 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 IQVO 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 for Dyspor and aesthetics in Europe would be great.

Okay. Thank you, Sophia. So taking your first question on our Curvo, what's going to be the dynamic now that Ocaliva withdrawal has basically washed out? So what you have observed is that We had a very nice growth in Q1 to let's say middle of Q3 and then Ocaliba was withdrawn and Q4 was a notable significant acceleration. 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, 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. So that is probably how you need to think about. And then comes on top of it, the unblinding of Elspire. So 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 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. 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. 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, 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. 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. 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. 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, 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. And then to the market share question, if I understood it right, this is for the AX. I'll let Emmerich answer.

Yes, 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. What you can see is that we are very pleased with the performance of D-SPORT in aesthetics in Europe, growing by 9.5% this quarter, and we expect that to continue for the year.

Thank you. Thank you. Your next question comes from the line of Victor Floch from BNP Paribas. Please go ahead.

Hey, thanks so much for taking my question, Victor Floch from BNP Paribas. Maybe first one on IQovo. I think in the past you've been strictly pointing out to a base case LOE around 2031. But if I'm not mistaken, there is a large family of patents that could extend the IP protection of IQovo. So any chance you could discuss the different options you have and whether we could expect a form of data on this at some point? And my second question is on osumatiline. So I think Amnil has said yesterday that they were actually asked, the FDA, to accelerate the review of their findings. 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 protect your market share in this market. Thanks so much.

Thank you, Victor. So on iQuerbo, as you have seen from our UDR document, we have the base patent expiring in 2031, but there are method of use patents which indeed can go significantly longer. So 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 Elifibernor 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 seven years on top of this for the PSC indication. Then on somatinib, I mean, you know, I'm now 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, you know, like when you have massive overall survival benefits with a new drug, etc. I mean, that was basically the discussion. So 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, 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. 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. So you have to make your assumptions here yourself. Thank you very much.

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. 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.

Hi, Charlie here with 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 and obviously would be a significant strategic decision. So if you were to go to loan, 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? And then third question, if we only see one SOMA generic in 27, and let's say we assume it's amnial, How should we, you know, broadly think about the Smatchlin outlook for 27? It feels like one generic would not be your sort of mid-teen to 20% annual decline needed for two to three generics. So is that close to sort of flat, slight decline? Is that fair, or how should we think of a good proxy there? Thank you.

Okay, so I start with your first question on IPN 10200, which we now call Corobotase. So it has a generic name. We don't need to remember any fancy figures anymore, so it's Corobotase. And, you know, 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. So, you know, 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. 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. Regarding the legal statements, I do not comment on legal statements from Golderma. What I can tell you is that the arbitration was very clear. We have full rights on Corabote ourselves. And then on the third one, I hand over to Emmerich.

Yeah, so thank you, David. So 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 characterized it in the past. It's only if we see more than one that we see a potentially more accelerated erosion for somatulin. So let's wait and see what happens, 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.

And, you know, 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 leaky syringes. And we have also observed that some of the generic producers had some air bubbles in there, etc. So the yields that you get and, you know, the 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 Sun Pharma as well. So it's not really an easy product to produce. The next question.

Thank you. Your next question comes from the line of Simon Baker from Rothschild & Co. Please go ahead.

Hi, this is Kisa Dean speaking for Simon. I have two questions. The first one is on Belvay. So is the Belvay sales force change complete or is there more to come? 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 between aesthetics and therapeutics? Thank you.

Okay, I didn't quite get your second question. Can you just repeat this?

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?

Okay, yeah, great. Thank you. Okay, so on BuildA, yes, I can say the field force implementation is complete. So they have been deployed last autumn. So now they're going out of the field and we clearly see the first effects. So we're very pleased with that. On 10200, as I said, it's called Corobotes now. 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 global aligned 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. And the same feedback we're getting in the therapeutics, you know, 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. 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 healthcare system, and it's going to make the healthcare 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. So I'm very, very excited about this drug.

Thank you.

And I think, operator, that was our last question, correct?

That is correct. Back to you now.

Okay, that wraps up our Q1 results conference. Thank you for having participated. Bye-bye.

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.