Hello and welcome to Ipsen's conference call and webcast on Q1 2024 sales update. I'll now hand you over to David Loew, Ipsen's CEO.
Thank you, Aymeric Le Chatelier. Good afternoon or good morning, everyone. I'm delighted to welcome you to our Q1 sales update. As you just heard, I'm David Loew, Chief Executive of Ipsen, and it's a pleasure to take you through our sales performance in the first quarter of the year. Please note that our presentation is available on ipsen.com. Please turn to slide 2. Before we begin, here is our safe harbor statement, which outlines the routine risks and uncertainties contained within this presentation. Also, any commentary on growth you'll hear today will be based on constant exchange rates unless stated otherwise. Please turn to slide 3. I'm going to take you through our brief presentation, after which I'll be joined for the Q&A session by our CFO, Aymeric Le Chatelier. Please turn to slide 4. Today's highlights add to our growing track record of consistent growth and strategic progress.
In the first quarter, total sales grew by 13%, and representing around two-thirds of sales, our growth platforms of Dysport, Cabometyx, Onivyde, and Decapeptyl again performed very well, this time up by a combined 16%. Our launch and pre-launch activities are progressing. With the recent approval of the Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma, or mPDAC, we're starting to see an increase in sales. We also have a busy program in rare disease. We're rolling out Bylvay in the US in its second indication, Alagille syndrome, and in the European Union, we await a regulatory decision in the summer. For Sohonos, we continue the launch activities for FOP patients in the US. We also anticipate a US regulatory decision regarding Elafibranor in second-line PBC on June 10 and an EMEA decision in the second half. The progress of the pipeline continues to be a key highlight.
Alongside the US approval of Onivyde, we also executed on our external innovation strategy through the licensing from Sutro Biopharma of an ADC asset in oncology. This represents a new and exciting modality for Ipsen, and we anticipate this asset moving into phase 1 clinical development in the near future. Furthermore, we entered with Skyhawk Therapeutics into collaboration on RNA targeting research in rare neurological diseases for 2 candidates having global rights. Lastly, we are confirming our full-year guidance today. We continue to anticipate total sales growth of more than 6% at constant exchange rates in 2024, alongside a core operating margin of around 30%. Please turn to slide 5. Turning to our sales performance in Q1, our growth platforms continue to perform well. Cabometyx and Dysport again stood out, while new medicines Bylvay, Tazverik, and Sohonos together made a meaningful contribution.
Somatuline sales declined only at 1%, and it's to Somatuline I'll turn first. Please turn to slide 6. In North America, Somatuline sales declined by 10%. The market is growing nicely, and we gained further share. Pricing conditions, however, remain unfavorable, with a changing channel mix and increased rebates continuing to impact overall sales. In Canada, we have not yet seen the expected entry of a generic lanreotide. In Europe, sales grew by 9% as we continue to benefit from competitor shortages. Our performances in France and Spain were particularly encouraging. Finally, in the rest of the world, sales increased by 15%, partially reflecting the performance in Latin America. Indeed, in the many markets where there is no lanreotide generic, we continue to deliver strong sales growth.
We do, however, continue to assume the possibility of further lanreotide generic entrance in the U.S. and the E.U. this year, though timing and magnitude remain uncertain. Now, let me turn to our growth platforms, which represent around two-thirds of sales. Please turn to slide seven. Dysport continues to deliver strong results. Sales grew by 19%, and market dynamics in both aesthetics and therapeutics continue to be very favorable. Cabometyx sales were up by 22% in the quarter, with robust volumes supported by market share growth with the first-line RCC combination. The performance did benefit from favorable phasing in the rest of the world region this quarter, which will naturally impact our Q2 performance. Decapeptyl sales grew by 3% in the quarter, and we continue to expect an average mid-single digit performance over the long term.
Growth in China remains strong, though we're seeing increased competitive activity in Europe as well as ongoing pricing pressure. I'll go through more details in a moment, but we've already seen a positive early start in the launch of the Onivyde regimen in first-line. With sales growth in North America of 15% in Q1, Onivyde's market share increased again in the post-GEM setting. Please turn to slide 8. Onivyde is off to a good early start in front-line, where there is significantly more potential than the limited post-GEM setting. The good news of the U.S. approval in February was accompanied by the granting of orphan exclusivity to 2031 in front-line. We already saw a positive uplift in post-launch demand in Q1 following the recent approval. We're confident that Onivyde has significant potential to address a high unmet medical need by becoming the new standard of care.
Initial KOL feedback has been encouraging across both academic and community centers, and we are pleased with the progress we have made in reimbursement and formulary access. Please turn to slide 9. Given the continued excellence performance of Dysport, I wanted to take a moment and single out the key drivers of Q1 growth for this important medicine. In aesthetics, we continue to see strong delivery in our markets and in our partners' markets, including the U.S. Our aesthetic sales grew by 24% in Q1, and we see sustained, attractive growth in the market, though Q1 did see some adverse phasing of sales in Europe. In therapeutics, we delivered 13% growth in the quarter, driven by North America and the rest of the world. Good market conditions continue in the therapeutic space, and we are seeing this across indications.
We're delighted with how well Dysport continues to perform, and we look forward to another year of strong growth. Please turn to slide 10. Looking now at our new medicines, they made an increased contribution in Q1. Bylvay sales of EUR 26 million reflected a strong performance and good patient uptake in PFIC, with volume demand growth and increasing number of Bylvay initiations in the U.S. In Europe, we're continuing to gain a significant number of new patients, though we are looking to address adverse pricing mechanisms that will impact our level of sales this year. Longer term, we anticipate further growth in PFIC, partially reflecting expected entries into new markets and more reimbursement to come. We continue to anticipate a progressive uptake in the U.S. in Alagille syndrome, and we're focusing on accelerating the number of initiations via the identification of IBAT-naive patients.
Tazverik sales amounted to EUR 12 million in the first quarter. Although we saw solid demand growth within follicular lymphoma, we expect that underlying conditions in the current monotherapy setting will remain challenging for the foreseeable future, with the potential for the level of competition to intensify. Finally, Sohonos sales amounted to EUR 7 million, following its U.S. launch in the second half of 2023. While sales were in line with expectations, patient uptake is limited given the presence of several clinical trials. Our launch focus in the U.S., however, remains on driving a sense of urgency to treat existing, diagnosed, and identified patients. Outside the U.S., we anticipate a regulatory submission in Japan and regulatory decisions in some other rest of the world markets this year. Please turn to slide 11. Moving to the pipeline, we have a number of milestones to come this year.
We await potential approvals of Elafibranor in second-line PBC in the U.S. and the EU, accompanied by a regulatory decision for odevixibat in Alagille syndrome in the European Union in the summer. The second half of the year will see the completion of the Contact-02 phase 3 trial of Cabometyx and Atezolizumab in prostate cancer, while in 2025, we expect pivotal phase 2 data for fidrisertib, the ALK2 inhibitor in FOP. 2026 will be a potentially significant year for Ipsen's pipeline, with phase 3 readouts expected for Tazverik plus R-squared in second-line follicular lymphoma, Bylvay in biliary atresia, and Dysport in both chronic and episodic migraine. Please turn to slide 12. Let me conclude our presentation. Ipsen's strategic roadmap is proving to be highly effective and is yielding strong results. We're certainly on track to deliver this year's plan.
Our top line continues to deliver, driven by the new launches and the powerful combination of our growth platforms. The pipeline is proving to be very productive, and we have the intention to expand it further with the addition of more assets through our external innovation strategy. And finally, we're remaining unrelenting in our transformation of Ipsen and the excellence of our execution. Please turn to slide 13. Thank you for listening to our presentation. Aymeric and I now have time for your questions. Operator, over to you, please.
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. Thank you. We will now take our first question. Please stand by. First question is from the line of Simon Baker from Redburn Atlantic. Please go ahead.
Thank you for taking my questions. I'll chance my arm and go for three if I may, please. Firstly, going back to the comments you made, David, on the environment for generics for Somatuline, we had a comment yesterday from Novartis saying that they've also seen more activity in the broader somatostatins generic market. I just wonder how that's changing your view on Somatuline beyond the specific impact of lanreotide generics. The second question was on Onivyde. As you say in the complaint and in the press release, you have a lot of IP around Onivyde, really going between 27 and 36. I assume that because of the 30-month stay of approval, the absolute worst case is late 26, early 27. But between that 27 and 2036, can you give us any steer of where you think it would be prudent to assume loss of exclusivity?
Then finally, a general question. We've started to see signs of life in the biotech funding market, in the IPO market. I was just wondering how that's been feeding through to the business development environment, how things have changed there in terms of the availability and pricing of assets that may be of interest to you? Thanks so much.
Thank you, Simon. I will start with your first question on generics on Somatuline and the comments from Novartis that they are seeing more activity on generics against Sandostatin and the potential impact. In fact, we're not really believing that there is going to be an impact because the generics really play against the drug that they are going against. And we have not seen, even when there was a generic of Sandostatin already, for example, in Europe, we have not seen any cross-impact on the other SSA. So we do not assume an impact by that. The second question on Onivyde IP. As we have always laid out in our URD, we have method of use patents also in second line for 2033 and then in the first line for 2036. And you have seen also that we just recently got the orphan drug designation until 2031.
So we are confident in our slate of patents. 2026, 2007, as you say, would be the absolute worst case, but I don't want to speculate on giving you a year given that we are in litigation with that company. So I can't really elaborate much more, but I can just reiterate that we are confident. On your third question regarding biotech and the recent funding, we are screening very actively. I think the price always depends on the attractiveness of the molecule. What we have seen is that really attractive molecules have not come down that significantly in terms of price. So we trust that we have enough firepower to actually deliver what we have announced. And so we are very actively screening as we speak.
Great. That's very clear. Thanks so much.
Thank you.
Thank you. We'll now take our next question. This is from the line of Lucy Codrington from Jefferies. Please go ahead.
Hi there. Thank you for taking my questions. Just thanks for that initial commentary on Onivyde and seeing that initial uptake. I just wondered if you could give any more detail on the feedback you've been receiving and also how we should be thinking about the sales evolution here. Is it likely to be gradual, or is a significant inflection expected? And then secondly, you mentioned that you were still confident in that mid-single digit outlook for Decapeptyl, but given that pressure in Europe is unlikely to abate, I just wonder if you could explain your confidence there. And then finally, just if you could touch on your preparations for the Elafibranor launch and how your thinking has changed or if it has changed at all now that Seladelpar is in the hands of Gilead and how that might influence negotiations when it comes to access. Thank you.
Thank you, Lucy. So the first Onivyde feedback, and we have to remember that it's not a very long time, right? I mean, we were six weeks now in that quarter where we were able to start promoting it. But the feedback is overall positive. We see clearly change in the inflection of the uptake curve. So that's very positive. We have several of the top 20 centers which have started to prescribe, and they have also provided access. So things are going according to plan there. On Decapeptyl Europe, there are some pricing effects where sometimes with governments, you have to renegotiate the price, and there is a little bit of an increased competition.
But there are also underlying dynamics that with the push of having more elderly people, more combination therapy, etc., that's going to increase the pool of patients to be treated, and it's also going to prolong a bit the treatment duration. So yes, we're confident on the mid-single-digit guidance that we have given overall for Decapeptyl because you remember that we have also, for example, large markets like China where there was this corruption audit, which is now coming to an end, and where we see China accelerating again. So overall, for Decapeptyl, we are confident. Then on the Elafibranor launch preparations, your question on does it change in terms of having Gilead as a competitor? Obviously, Gilead is a formidable competitor because they have a long history in hepatology. However, more in mass markets, I would say hepatology than in rare disease. PBC is a rare disease.
And so we think what's going to happen with two strong players playing in that space, it's actually going to accelerate the expansion on the market, which is something which is positive for patients for sure because you have two companies really working on that. And then how the market share is going to pan out, we will see. What I can say is that where we have faced well-known companies, like for example, we have faced Novartis on Sandostatin, but we have also Pfizer or MSD against Cabometyx, we were able still to have a number one position. So we will see how this is going to pan out. So thanks a lot. Next question.
Thank you.
Thank you. We'll now take our next question. Please stand by. This is from the line of Richard Vosser from J.P. Morgan. Please go ahead.
Hi. Thanks for taking my questions. A couple, please. Firstly, on Dysport, you mentioned some sort of stocking reductions in Europe, which affected growth. But was there a catch-up on shipments to Galderma? It doesn't sound like there was. So I suppose the question is really, how sustainable is this level of growth? Should we see any variability going into Q2, and how should we think about Dysport going forward? And then second question on Bylvay. You mentioned the price caps in Europe. How can you renegotiate or change those to your advantage? How long could that take? And I suppose, what sort of is that all pervading across all of Europe, or how should we think about that? Thanks very much.
We'll hand the first question to Aymeric on the stock effects and the sustainability of the growth.
So thank you for the question on Dysport. So as you see, for the first time this quarter, we are disclosing the split of the sales of Dysport between, on one side, the aesthetic market, which is made of our sales to Galderma, but also our Ipsen sales in aesthetic, and the rest of our sales, which are mainly in therapeutic. As you said, there have been some stocking impacts, which have unfavorably impacted the European performance. But on the other side, I think in the U.S., we had some catch-up, and you were asking the question about is there some catch-up. There has been some catch-up of a low Q4 performance, especially in aesthetic. So your question is, overall, I think we are to a very strong year for Dysport.
There will always be some seasonality, especially on the sales to Galderma, as these are ex-factory sales that we are shipping, which are not directly linked to the demand. But overall, we are expecting a very strong year for Dysport across both aesthetic and therapeutic.
On your second question regarding Bylvay price cuts in the European Union. Your first question was, is it across all Europe? The answer is no. There are only a few countries which have these caps. For example, in France, you have a cap, or in Italy, you have certain price decreases when you hit a certain threshold. It's not across the board. We will not elaborate on the renegotiation or the change efforts that we are doing because we're in a competitive environment. Mirum is going to launch also potentially in PFIC. I don't really want to elaborate on this if you understand.
Understood. Thanks very much.
Thank you. We'll now take our next question. Please stand by. This is from the line of Xian Deng from UBS. Please go ahead.
Hi. Thank you for taking that question. I've got three, please, if I may. The first one is, the Q1 has a pretty decent beat, but you still reiterated the full-year guidance. So just wondering, why do you not raise the full-year guidance? And could you highlight, is there any part that in the Q1 performance you are expecting to reverse for the rest of the year? And second is that for Somatuline generics, I understand that you said the impact and timing for generics is not very clear. But just wondering if you could elaborate a bit more about your assumptions for your full-year guidance on this one, please. And the third one is, if I may just follow up a bit on Dysport, please. So the 24% CER in aesthetics, it seems very strong.
I was just wondering if you could elaborate a bit more in terms of, do you see the growth mainly come from general market recovery, general market growth, or are you also seeing Dysport taking market share? Thank you very much.
Thank you, Xian. So on the first one, I will hand this to Aymeric.
Yeah. So regarding the full-year guidance, as you know, we are only in Q1. So we're very pleased with the performance in Q1. As you've seen, that has been fueled by a very good performance of Somatuline given the shortage that we've seen in Europe and also benefiting from scope impact with the launches of Sohonos and also the full-year impact of Bylvay that we acquired in March of last year. So we are fully in line with our expectation. And as we said at the time of the guidance in February, we expect more generics to enter the market of Somatuline during the year, which is, by the way, your second question, where our assumption is that there will be both in the U.S. and in Europe more generics to enter the market.
As David said, we don't know about the exact timing, and we don't know about the quantification. We know that the impact is going to be mainly in Europe given the timeline for reimbursements outside of the U.S., where it takes usually a few quarters before the products are launched from approval. This is clearly what explains the early good start of the year why we are only confirming the guidance today.
So to your second question on Somatuline and the assumption on entrance. I mean, as we said in past calls, it's very difficult to predict when exactly additional generics could come in. The reason is that it's very difficult to produce substance and formulation as well as the device. And so, for example, in Europe, we know that Sun Pharma has submitted in 2022, but they are actually stuck in clock review since more than nine months now. So it's hard to predict what's going on there and when they would come. So I think we can safely say in Europe, it's probably the earliest at the end of this year. In the U.S., it could be that we have, of course, a 505(b)(2) that at one point, they could launch an ANDA, so a full generic status.
But again, it comes also down to having the volumes and additional competitors. We hear that there are other ones which are in discussions with the FDA. But it's really hard to predict the precise timing. On your last question regarding the aesthetics growth, we don't think it's a recovery. We actually think it's an expansion of the market. And to your second question, are we gaining market share? The answer is also yes. We have several markets where we are gaining market share. Next question.
Thank you.
Thank you. We'll now take our next question. This is from the line of Thibault Bouterain from Morgan Stanley. Please go ahead.
Yes. Thank you. Just two questions, please. The first one is a follow-up on Onivyde IP. As you mentioned, worst case for IP in 2026, 2027 with potential for longer IP. I'm just wondering, what is spec'd in your peak sales target for Onivyde in terms of IP duration? So basically, do you think you can do the EUR 500 million peak even with a shorter IP, or do you need some of this IP protection to remain valid for longer in order to reach that figure? Because obviously, there's consequences in terms of how fast sales need to accelerate from the first line to reach that level by 2027. Second question is just on the catalyst for Cabometyx in second-line prostate cancer, OS data. Just wondering if you could put this in context with your EUR 700 million guidance as well. Is it material to reach that guidance?
Should we see this as a potential upside? So yeah, just if you could give that in context. Thank you.
Yeah. Thank you, Thibault. I just want to make first a correction on Onivyde. You mentioned 2026, 2027. Under no circumstances is 2026. I mean, the absolute worst case is 2027. And then, as I said, we have these additional patents with 2033 and 2036. So that gives us more runway, and we're confident that these patents are going to hold. The peak sales that we have guided is above EUR 500 million, and we assumed that we would achieve them by 2027. On your second question on Cabometyx in second-line prostate, it's a very small part of the EUR 700 million. So it was heavily risk-adjusted. And so it would be upside if we would hit that. We're going to get to the EUR 700 million with the current trajectory that we have with the current indication.
Thank you.
Thank you. We'll now take our next question. Next question is from the line of Florent Cespedes from Bernstein. Please go ahead.
Good afternoon. Thank you for taking my question. Can you hear me?
Yes.
Excellent. Many thanks. So Florent Cespedes is from Bernstein. Two questions, please. First, on Onivyde, I'm just wondering if you could give us a little bit more color on the timing or next step regarding the lawsuit. So when you will be in a position, when will you know, when will there be some hearings? Or if you could elaborate on this when we should have more visibility on this process. That's my first question. And my second question, an easy one, on the slide one with your excuse me, slide 11 on the newsflow, pipeline newsflow. What is, in your view, which are the most important, or what is the most important milestone, in your view, in this slide? Thank you.
So on your first question on Onivyde, on the timing of the next steps of the lawsuit. So we have already started the lawsuit. So that's already ongoing. We can't really provide details. There is, however, a stay, which is at the minimum 30 months, as you know, from the U.S. Waxman-Hatch Act. So that's why we say the absolute worst case is 2027. But the details on when the judge is going to decide, etc., we don't have visibility. That's really up to the judge. Then on the newsflow, in terms of what are the most impactful, were you alluding to 2025 and 2026, I guess, not to 2024, where we elaborated already? Is that right?
Yeah.
So I would say clearly, the BA indication of Bylvay is a very significant indication, as well as on Dysport, the migraine episodic and acute, as well as Tazverik on the second line, follicular, because that really opens up a bigger market. So I would say they are probably broadly similar in terms of potential among the three. But all three are very substantial. The fidrisertib is a little bit smaller, I would say, because FOP is just an ultra-rare disease. And there will be potentially some cannibalization of Sohonos with fidrisertib if fidrisertib shows a better profile and shows also a younger age. But we really need to see more data there. And eventually, the two products could also be combined. But fidrisertib will be smaller than the three other ones that I just mentioned.
Okay. Thank you very much. Very helpful. Thank you.
Thank you.
Thank you. We'll now take our next question. Please stand by. This is from the line of Alistair Campbell from Royal Bank of Canada. Please go ahead.
Hi, everyone. Thanks very much for taking the questions. I'd like to ask about two products if I can. First of all, just on Bylvay, I mean, you talked about good growth in Q1, but actually, the quarterly progression from Q4 into Q1 was obviously less dynamic. So can I just understand a bit more about that competitive intensity between yourselves and Livmarli? I know they have talked recently about feeling that they have advantages in Alagille in terms of pediatric dosing. And in PFIC, they talk about sort of deeper pruritus responses as being something they're pushing. So just trying to understand how you feel you compete currently with Livmarli as it comes to market, particularly now in PFIC. And then maybe if we could turn to STRO-003. I know it's very, very early days, but just wondering what you saw on that product.
Obviously, there are other ADCs a bit further ahead in the clinic, but sort of what do you see there in terms of potential differentiation? And given that ROR1 expression can actually be found in quite a number of tumor types, both liquid and solid, kind of is this something which, if it pans out, you could see having peak sales potential kind of Somatuline plus, or is this something you see more in the kind of Cabometyx, Onivyde kind of scale? Thank you.
Thank you, Alistair. First, on Bylvay and the Q4 to Q1. I mean, we have to remember that in rare disease, you can have several patients come on drug in a short period, and sometimes they come kind of in batches. And it takes sometimes time to get reimbursement. So I don't think we should look in rare disease launch on a quarter by quarter. There was also a little bit of a seasonality effect from Q4. And as I mentioned before, and as we heard some questions also, a little bit of adverse European pricing mechanisms in Europe. So coming now to your question on the Alagille and PFIC situation. So on the pediatric dosing, I think there is not really an advantage that Livmarli has. I think we actually think they have a slight handicap. Now, I need to specify that a bit.
When you have a very small baby, some physicians could still perceive the liquid formulation as an advantage. But what we need to still explain better - and Livmarli, of course, had a head start in Alagille - is that with Bylvay, you can actually open the capsules, put it in a little liquid, 2.5 milliliters, and dilute it and take it into a syringe and inject it into baby's mouth, which is very easy to do. I mean, I have had three babies myself a long time ago, and I know that this actually works. So there is a piece of explaining that a little bit better.
And then we have the advantage that when the baby grows up, as soon as they can have solid food, and that's at a very young age already, you can actually sprinkle the granulates over applesauce or chocolate pudding. And as we know, babies like these foods, and it has no taste, which is also an advantage that we have. And then when they grow older, they can go in the capsule. So I think it's up to us now to explain that still to the physicians. I went out myself and did some double calls. And it was interesting to see that even some of the top KOLs actually didn't even realize that there are two different formulations because they just click on the electronic medical system. They generate the prescription, and it's actually the pharmacist delivering it.
One of the KOLs said like, "Oh, you need to tell everybody." So it's an execution question that we have to get better at still. Then on PFIC, I think we have a very good situation here because they just got an approval in the United States, which has a tough label, I would say. I mean, it's age five and above. The label has several restrictions. So I think we are in a very competitive situation in PFIC here. On Sutro, on the question, what attracted us on this one, and what could be the potential? So as you stated, it's a next-generation ROR1 ADC. Now, ROR1 is, as you mentioned, actually present in several tumors. We will, of course, look in which tumors it's going to be overexpressed so that we can have kind of a follow-on strategy going off the not-too-high biomarker tumors.
Now, RAW1 can be expressed higher in some tumor types than in other ones. So we will carefully look at this. Where can we really win? Clearly, if the drug is as differentiated as we hope it is because it's a next-generation one, and Sutro has very site-specific technology to generate a highly stable conjugate coupled with an exatecan payload that shows significant potential in solid tumors, it could become a pretty big drug. And when we did the capital markets, we said we can go for drugs which can become much bigger than the EUR 3 million-EUR 800 million, especially coming from the preclinical, because they are still more affordable than when they are, for example, in phase 2 or 3, and they have a sales potential above EUR 1 billion. That's where we get into heavy competition with larger companies.
In the preclinical space, we can find those kind of hidden jewels and partner with them. So we see Sutro as one of those.
Thanks, David. Very helpful.
Thank you.
Thank you. We'll now take our next question. This is from the line of Manos Mastarakis from Deutsche Bank. Please go ahead.
Hello. Thank you. Manos Mastarakis from Deutsche Bank. Just wanted to get your thoughts on the potential risks for an Elafibranor approval. How are you thinking about a potential outcome? Is this completely now out of the question? As well as each component in the label. Thank you.
So I would say the outcome is now highly unlikely because, I mean, we are very advanced now in the process. With the June 10 PDUFA dates, we are starting to get very close to it. I think it's highly unlikely that we're going to have an advisory committee. On each component of the label, obviously, for competitive reasons, I cannot comment on this. Label proposal has gone in. We are following the process now, and we are looking forward to then communicate on the robustness on the label once we get the approval. Thank you. Next question.
Thank you. We'll now take our next question. This is from the line of Richard Parkes from BNP Paribas Exane. Please go ahead.
Hi. Thanks very much for taking my question. Yeah, I'm not sure if this has been covered before, but just wondered if you could talk about your confidence or optimism in Bylvay, in the Biliary Atresia phase 3 study, given failure of the prior phase 2 trial of Livmarli in that setting towards the end of last year. Just wondered if you'd had an opportunity to assess that and see what implications it has for the class in that setting and your optimism around the phase 3 readout. Thank you.
Yeah. Thank you. I mean, we have communicated on the Livmarli trial already in the past. Actually, it has panned out exactly as we thought it would pan out. They have, in our view, taken the wrong endpoint, which is not the endpoint that actually FDA has requested because they went for a biochemical endpoint, not for an outcome endpoint. After Biliary Atresia , you need to have sufficient follow-up. They only had 6 months follow-up. We have much, much longer follow-up, and we are measuring if it impacts actually on hard outcomes like liver transplantation. So we are following up the patients much longer because Biliary Atresia is a gradual, slow process. You also need to have kind of the washout of the effect of the Kasai procedure.
So that's why we increased, actually, the sample size to make sure that we can have the confidence levels on the statistics that we need to have and that we have enough patients with enough follow-up getting to the endpoints that we want to see. Our probability of success has not changed on Bylvay in Biliary Atresia . We feel confident that we can get there. We don't think this has anything to do with the class. I think it has to do with the way this trial was designed. Now, we heard from Mirum that they have stopped the BA development, which is understandable because now they have such a difference to us. We have such a head start that it's probably not lucrative for them anymore to try to get there.
Perfect. Thank you very much.
Thank you. I think that was our last question. With this, we wrap up our Q1 conference. Thank you very much, everybody, for attending.
Thank you. This does conclude the conference for today. Thank you.