IPSEY Q1 2025 Earnings Call

Operator: Hello, and welcome to Ipsen’s Conference Call and Webcast for the First Quarter 2025 Results. I’ll now hand you over to David Loew, Ipsen’s CEO.

David Loew: Thank you, and hello, everyone. I am delighted to welcome you to our Q1 sales presentation this afternoon, which can also be found on ipsen.com. Please turn to Slide 2. Please take note of our forward-looking statements, which outline the routine risks and uncertainties contained within this presentation. Also, any of my commentary on growth will be based on constant exchange rates. Please turn to Slide 3. I am going to take you through our sales performance of the first quarter, I’ll provide you with the business update of the which our CFO, Aymeric Le Chatelier, will drive me forward the question-and-answer session. Let’s begin by looking at today’s highlights. Please turn to Slide 4. We continue to deliver a strong top-line growth in quarter one. Total sales grew by 11.6% driven by all three therapeutic areas and including an increasing contribution from Iqirvo and Bylvay. Since the beginning of the year, we have made good progress with our pipeline including the EMA regulatory submission of the Tovorafenib for the pediatric low-grade glioma. The entry in Phase 1 of the third generation RAF inhibitor complementing our ERK inhibitor with both being in the clinic. On the financing side, we announced in March a successful refinancing of $2 billion including a $500 billion rated public bond, supported by investment grade ratings from Standard and Poor's and Moody's. This provides long-term funding of the firepower for our external innovation strategy. Looking ahead, 2025 promises to be another exciting year for our pipeline with several key milestones, including the expected decision from the EMA for Cabometyx in NeuroEndocrine Tumors in Europe, Fidrisertib pivotal data in Fibrodysplasia ossificans progressiva or FOP and the first proof of concept data for our long-acting neurotoxin in aesthetics. Lastly, we confirmed today our 2025 guidance with total sales growth greater than 5% at constant exchange rate and a core operating margin greater than 30% of sales. Please turn to Slide 5. All three therapeutic areas have seen strong growth in this quarter. Oncology has performed well, growing by 8%, driven by the strong performance of somatillin. Rare disease continues to stand out propelled by the sustained performance of Bylvay and Acorba launches. Neuroscience comprising this work delivered strong and consistent growth close to double digit. And now I'll turn to oncology for more detail. Please turn to Slide 6. Starting with the Masoline, sales were up 19% in the first quarter with good performance in the U.S, Europe and rest of the world. This growth reflects the continued shortages of generic lanreotide in The U.S. And Europe. During the quarter, we saw some limited signs of generic lanreotide supply progressively recovering in The U.S. And Europe, still with some inconsistency. Sun Pharma, along with its partners, Viatrice and Sentiva, have received several local approvals following the decentralized procedure, but have not yet launched. Approval in The U.S. is still expected later this year. Cabometyx sales were down by 3%, driven by a very high 2024 baseline as well as price pressure in some rest of the world markets. However, Cabometyx performance was strong in Europe with increased volumes in both first- and second-line renal cell carcinoma. Decapeptyl was back to growth in quarter one with sales up by 3.4%, driven by solid volume growth in Europe and China despite continued competition and pricing pressure. Onivyde sales rose by 6.3% with a limited market share growth in The U.S. In the first line metastatic pancreatic ductal adenocarcinoma indication. We continue to work on driving first-line differentiation and on addressing some challenges with access to payers that we have been facing since the start of the year. Now let's turn to rare disease. Please turn to Slide 7. On the rare disease, Bylvay continues to perform nicely with Q1 sales of $43 million representing growth of 63%. This performance was driven by increased sales in The U.S. in the PFIC indication where we enjoy a strong leadership position and in Alagille Syndrome with uptake from naive and switch patients. We also see a strong momentum in Europe, mainly driven by the PFIC indication and market expansion. Turning to Iqirvo, the launch continues to track well in line with our expectations with sales reaching EUR23 million this quarter. The growth in The U.S. Was driven by an increasing patient uptake from new patients and patient switches from Ocaliva. Additionally, I'm also pleased by the successful launches in Germany and The UK contributing to the strong performance. We're expecting more countries to launch in 2025. Moving to neuroscience, let's turn to Slide 8. Dysport delivered another solid performance with sales growth of 9.6% for the quarter. In aesthetics, sales grew by 16%, driven by continued expansion in most territories, including the U.S., Europe and rest of the world. On the therapeutic side, reported sales were flat despite a solid growth in North America and Europe, offset by shipping phasing and the high 2024 baseline in Brazil. Moving to the pipeline, please turn to Slide 9. You can see our well-balanced portfolio that continues to grow across the therapeutic areas and phases of clinical development. As I mentioned earlier, in our oncology portfolio this quarter, Tovorafenib was accepted by EMA for review, marking important step forward in the development of this potential treatment for pediatric low-grade glioma and reinforcing Ipsen's commitment to innovation in rare and difficult to treat cancers. I'm pleased to see that the third-generation RAF inhibitor from our preclinical pipeline has entered Phase 1 trial. This asset will reinforce our ERK inhibitor and Tovorafenib, two other assets targeting the MAPK pathway. We are anticipating more preclinical assets to progress this year and in the near future. I would also like to draw your attention to the ICORVO ELMUD Phase 2 trial results in PSC, which are going to be presented in a late-breaking session at EASL beginning of May. Now I would like to share more about our upcoming data readouts this year. Please turn to Slide 10. There are a lot of exciting milestones that we expect this year and next year. Let's focus on 2025. First, in oncology, we are expecting a decision from the European authorities on Cabometyx in pancreatic and extra-pancreatic neuroendocrine tumors. In rare disease, we are looking forward to the readout of FALCON, our registrational Phase 2 study with fidrasertib in FOP. Lastly, we anticipate the first proof-of-concept data for our long-acting neurotoxin anesthetics. We believe LANT has the potential to deliver better outcomes for patients with an increased duration of action, leading to a reduction in injection frequency. In that context, I'm delighted that Olivia Bryan recently joined our executive team to help build an integrated neurotoxin franchise and drive and accelerate our development growth and innovation in neurotoxins, both in the therapeutic and aesthetic space. I will now move to conclusion at LiveLook for 2025. Please move to Slide 11. Ipsen has delivered a strong start to 2025. 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 are increasing our investment in our launches and our preparations for upcoming milestones as we advance our pipeline. To further strengthen our pipeline, we will continue to diligently evaluate external innovations, leveraging our firepower. With that, please turn to Slide 12. This concludes our presentation. Aymeric and I will now take your questions. Operator, over to you.

Operator: [Operator Instructions]. We'll now take our first question. This is from the line of Shan Hama from Jefferies. Please go ahead.

Shan Hama: Just two from me. Albeit, I know you can't speak for Galderma, but what do you think has driven the strikes and the aesthetics for Dysport in its respective markets? And I know there was some commentary on U.S. softening, but it looks as if maybe Ipsen and Galderma are pretty immune to that. And then secondly, appreciate you may have a lot of incoming on this, but just for clarity, how do you view the potential imminent pharma tariff impact? Thank you very much.

David Loew: Hi, Sean. Thanks for your questions. Regarding your first question on aesthetics in the U.S, so we are very happy with the performance of our partner, Galderma, in The U.S. Regarding softening of the market, I think you're better placed to ask them directly since they are really our distributor in the U.S, but the performance is very good. On your second question on tariffs, I mean, there hasn't been really an announcement on tariffs yet. So, it's too early to speculate about any potential impact on the tariffs. So, we are carefully watching the space, carefully watching the announcements, obviously, but we don't want to speculate at this point on what the impacts could be.

Shan Hama: Thank you.

Operator: Thank you. We'll move to our next question. This is from Jon Priesner from JPMorgan. Please go ahead.

Jon Priesner: Hi. John Priesner from JPMorgan. Thanks very much for taking my questions. Just a couple, if I may. So maybe first on Dysport again, kind of how should we really be thinking about the growth trajectory in 2025 given you're off to a good start? Could it be a similar level to 2024 in the high single digits or could it actually be even stronger? Then maybe a second question on Somatuline. So, sales were very strong obviously in Q1 coming in with about 20% local currency growth. So, can you help us understand the kind of how much is baked into the 2025 guidance in terms of Somatuline erosion and what are some of the pulls and pushes here? And then maybe one final question just on pipeline, which you mentioned the Iqirvo PSC data at EASL next month. So maybe can you help us understand how Iqirvo could fit into the current treatment paradigm in PSC? How the competitive landscape is looking? I think some competitors have some IBACs in development in this area. And maybe how big of an opportunity that could be, and whether that's included in your current peak sales target for Iqirvo? Thank you.

David Loew: Thank you, John. So, on the first question, yes, we continue to assume high single-digit growth, so similar to what we have been observing so far. I will take your third question because then I'm going to hand over to Aymeric on the guidance on zamethalin. So, on your third question regarding pipeline and Iqirvo in PSC, so this is a Phase 2 trial, which had as a primary endpoint of safety, but has a secondary endpoint also liver function values like ALP, for example, but also fibrosis as an example. And you're going to see data at the late-breaking session at EASL. We have to now consult with regulatory authorities to see what are our going to be next steps forward. This has not been included in our guidance. The size of the opportunity, I think it's too early to comment on. Of course, there is a very high unmet medical needs in PSC. There is really nothing to treat these patients. And so, we will have to see how big this could become and what are the timelines because FDA typically wants to see outcome-driven trials. In terms of competition, it's correct that there are some IBADs, which are going to focus on pruritus, but PSC, of course, is larger than just the psoriasis story. I mean you also have or you want to protect the liver and liver values potentially can play a role in the fibrotic process. So, work in progress. We're pleased to see those results, but more to come, and we are going to more talk about this in future steps. Regarding Somatuline, I hand over to Aymeric.

Aymeric Le Chatelier: Yes. So, thank you, David. Thank you for the question. So, as you point out, our guidance is not assuming that Somatuline will continue as in Q1. Clearly, we are fully on track with what we said in February that we expect an accelerated erosion of Somatuline in 2025. You asked about the push and pull. Clearly, that erosion will be driven by two elements, as David explained during the presentation. First, it's a progressive resupply of [Indiscernible] impacting Cipla in the U.S. and also advanced in Europe and other territories. And the second element is clearly the entry of an additional generic from Cipla, which has started to -- from Sun Pharma, sorry, from Sun Pharma, which has started to be approved in Europe and will likely be approved based on our guidance in the second half of the year. So clearly, the pool and push are going to be related to the timing of those resupply and whether Sun Pharma is going to be able to supply, launch, but also secure an approval in the U.S.

Operator: Next question is from the line of Florent Cespedes from Bernstein. Please go ahead.

Florent Cespedes: Good afternoon. Thank you for taking my question. Two quick ones, please. First, on Cabometyx. Could you come back on the dynamic of this product for this year as it was a little bit short of expectation this quarter if you see further pressure or maybe some territories dispute performed better during the rest of the year? That's my first question. And second question is about your M&A and business development BD strategy, given the uncertainties on tariffs -- do you see some potential deals kind of on hold to see any changes on the dynamic of this -- on this strategy? Any color would be helpful.

David Loew: Thank you, Florent. So, on CABOMETYX, in the markets where we have launched first in the most of the Western markets, we are starting to achieve very solid market shares in first line. So, I would say we have to expect, as we guided, a bit less strong growth. So, it's probably going to be in the single digits rather. And then we have seen in the -- some of the emerging markets, some pricing impact -- so overall, cap will continue to grow. We are very confident on our above EUR700 million peak sales guidance that we have provided to the market and any additional sales coming from the neuroendocrine tumor would be on top of it. Regarding your question on M&A, we do not foresee to change our BD strategy based on tariffs. As you know, of course, the whole market has seen a correction. Many shares went down, including many of the biotech shares went down. So that has to be taken into account as well. So -- but we're not holding any activities. We are screening as we speak regularly any deals which appear interesting to us.

Florent Cespedes: Thank you, Florent. Thank you very much.

David Loew: Next question, please.

Operator: Thank you. Next question is from Xian Deng from UBS. Please go ahead.

Xian Deng: Hi. Thank you very much. Thank you for taking my questions. I guess the first question I have a few, please, if I may. So, the first one, just want to sort of follow-up a little bit more in terms of potential tariffs and manufacturing locations. I'm just wondering if there's any color that you could give us in terms of percentage of sales that are manufactured in the U.S, any if you have any royalty structures, let's say, from your U.S. Subsidiary to European subsidiary, if you have any of that, any color on that sort of just how you actually structure the logistics, that would be great. That's the first question. And then the second one is on Diforce. Just wondering, yes, first of all, thank you very much for the color on your expectation of high single-digit growth. But just wondering, let's say, if U.S. Goes into recession this year, just wondering what are your thoughts on the potential impact into your guidance and what have you assumed for BioSpore to perform in your guidance, please? And then third, just a quick one on Somatuline. So, you mentioned some generics start to pay cut in supply, but they kind of intermittently. So just wondering, from what you're seeing at the kind of at a similar pace as what you expected at the beginning of the year, what you're assuming in guidance or have they been either faster or slower than what you have assumed? Thank you very much.

David Loew: Thank you, Xian. On your first question, I just want to make sure that I got the question correctly. So, you were asking regarding where we manufacture and where we sell. I didn't quite understand the royalty’s question there. Can you perhaps just specify that what you mean by the royalty’s question?

Xian Deng: Yes, sorry. It's just to do with some companies like for example, they have the IP rights located in Europe. Then sometimes they use a U.S. Subsidiary to pay a royalty to the European subsidiary to access a patent. So, some company does that. So yes, just wondering.

David Loew: Okay. Yes. So, I can just repeat because that's a very specific question. I can just repeat what I said before. Tires are not in place. There are no details that we know like on what they would be applied exactly, et cetera. So, I don't want to actually speculate on this. What I can tell you is that most of our manufacturing comes currently from our current production sites, which most of them are in Europe. We have some CMOs also in the U.S, but the large majority is coming from Europe. So that's all what we can say currently. On this part, if there would be a recession, yes, I mean, we would have to potentially assume that it could impact our aesthetics business most probably. But again, we don't observe this right now. And I think for further clarifying questions, I think it's best that you actually talk to our distributor, Galderma, because they have the majority of our disparate aesthetic sales and it's also they have the distribution in The U.S. So currently, what I also can say is that we have not included recession in the guidance so far. So, we will have to take this into account.

Aymeric Le Chatelier: And maybe, Xian, to remind everybody, Dysport estate in the U.S. is less than 5% of our sales. So, the impact is pretty limited to the overall guidance. And as we know, toxin is a pretty resilient product even if it's out of pocket. So, I don't think that we have a significant exposure to a U.S. recession.

David Loew: Regarding your third question on Somatuline generics and the pace of return, I would say, advanced and simple I have in the past made statements that they're going to be back in a given time frame and then this has actually not materialized. So, the current comeback of Somatuline is, in fact, in line with our expectations. It's very gradual sketchy, as I said before, when we went through our slides, but we want to be careful because it could be that they are fixing their problem, and that's why we have guided -- as we have guided. So, we do assume an acceleration in the coming months and in the second half of the years with the potential entry also of Sun Pharma.

Operator: Next question is from Simon Baker from Redburn Atlantic. Please go ahead.

Simon Baker: Thank you, for taking my questions. Just to revisit the manufacturing footprint, perhaps if I can ask it in a slightly different way. I believe you manufacture Onivyde in Cambridge, Massachusetts. Are there any other significant manufacturing activities at the product level you would call out for the U.S.? And then moving on to IQIRVO. Perhaps you could just give us an update of good performance in the quarter, an update on the dynamics between you and Gilead and PBC and also an update on the nature of the patients you're getting where they're coming from and any characteristics that are developing there? And then finally, on fidrisertib, in light of the [Indiscernible] experience, I wonder if you could give us an idea how we should be thinking about what looks like a clinically meaningful result from that data? Thanks so much.

David Loew: Thank you, Simon. On the manufacturing, we have -- we don't go into the detail for every single product on this. So, as you have stated, we still have had some manufacturing on Onivyde from the U.S. And we have, for example, CMO for Sohonos also in the U.S. To your second question on IQIRVO and the dynamics in PBC. So, it's tracking actually really well and in line with our expectations. So, as we have said before, we have been assuming about 1/3 of market share, which is what we are seeing currently. And then in terms of your question on the split of patients, so we see about 60% of the patients coming de novo second line and the rest from Ocaliva switches either -- they are currently on Ocaliva, they are being switched actively or they were on Ocaliva before and are now being put on Iqirvo. Regarding your third question on fidrisertib, clinical meaningful difference. I mean here, it's the HO formation that we are measuring, the difference [Indiscernible] is that on the inclusion of the patients, we allow patients as of the age of 5 and above, so much younger patients and FOP actually starts at an early age when they are young. So that's certainly going to be an advantage versus the whole note. And also -- we do not anticipate any safety problems contrary to Tahonis where we have seen premature growth platelet closure, as you know, and that has been a bit of an impediment on the pickup of the drug. So, I think with FEEDRI, if the efficacy is good, it could really bring a very meaningful new option to these patients around the world. Thank you. Operator, next question, please.

Operator: Thank you. Next question is from Manos Mastorakis from Deutsche Bank. Please go ahead.

Manos Mastorakis: Hello. Manos Mastorakis from Deutsche Bank. Thanks for taking my question. So first one, just quick comments on your overall commitment and interest in the MAPK pathway and what have you seen with the IPN 1195 asset that makes you excited? And secondly and lastly, in Q1 and PSC, you mentioned fibrosis. That makes me think of NASH. Have you considered or are you considering any kind of development in that space? Thank you.

David Loew: Thank you, Manos. On the RAF inhibitor, it's actually a third generation RAF inhibitor, which makes us quite excited and especially also the potential to combine it with our ERK inhibitor, which is already in Phase 1 because the combination of them could be giving very beneficial effects potentially. We have to see if we get synergistic effects. And that's what makes us very interested because RAF inhibitors, but also ERK can be used in several different tumor types. And we are now entering and randomizing the first patients into the dose of ascending. So, we have to see how the drug behaves. And then determine in which tumors we're going to develop it. We are of course also looking at potentially seeing are there accelerated approval pathways. So that makes us excited. We think it's a new generation, third-generation inhibitor, and that's quite exciting. On your second question, regarding your question on fibrosis and NASH, remember the PPARs were actually tested in NASH before. They didn't make it. And then they were developed in PBC, where they absolutely show really good efficacy and safety. So, we do not anticipate to go actually back into NASH because that trial was done at the time by Genfit, and it didn't work out like on seladelpar, it didn't work out on NASH neither. So, we don't think that this is the indication we want to go after. Thank you.

Manos Mastorakis: Thank you.

David Loew: Thank you. Next question, please.

Operator: Thank you. Next question is from Alistair Campbell from RBC. Please go ahead.

Alistair Campbell: Afternoon. Thanks very much for taking the questions. Two, please, if that's right. Just first of all, on Iqirvo. Yes, I think if you look at Advanced, certainly from a European perspective, they're talking about a significant dip in Ocalaiva sales this year. So maybe if you could give some hints in terms of your European rollout, the speed of which you can roll out into more markets and potentially capture that opportunity. And then maybe just digging a bit more on the PSC area. So, two assets in Phase two. And David, you touched that one might be more to do with pruritus, the other one might be more to do with liver function. But could you see an opportunity to take both of these into Phase 3 and ultimately both to market? Or do you think you kind of have to pick a favorite and how could they work together? Thank you.

David Loew: Thank you, Alistair. On your first question, yes, Ocaliva is really dipping in Europe as since it is being withdrawn. So, patients are being switched very rapidly. So, the rollout is actually going very, very well. Europe has taken off very nicely. U.K. as well. We anticipate new markets coming on, like, for example, Italy, very soon. And we're working on getting the other markets also launched and reimbursed very soon. So, an exciting launch, definitely also ex-U.S. On your question on PSC. So, we have ritevixibab in Phase II. We need to still see more results on [Indiscernible], and we also have a succession compound which is actually more potent in preclinical. So, we are just discussing which one are we going to choose. As I said before, the IBAT inhibitors are more going to control the pruritus effects of the disease. And I think the PPAR and IQIRVO here, very specifically, which has a different mechanism of action from other PPARs, could potentially play a role here. We have to now assess in more details, and we are looking forward to having the discussions also with KOLs and regulatory authorities. But they're going to satisfy two different needs. I mean PPARs potentially would have an effect on the liver function, also long-term. So that's different to just controlling the pruritus.

Operator: Next question is from Laura Hindley from Morgan Stanley. Please go ahead.

Laura Hindley: Laura Hindley, Morgan Stanley. Just firstly, going back to Somatuline. Are there any key differences that we should be aware of on the expected erosion cadence between the U.S. and Europe based on the trends that you've seen so far in Q1? And then on Cabometyx, how much of an incremental opportunity do you see for the neuroendocrine tumor indication? How quickly can that ramp up, just thinking about the patent expiry towards the end of the decade? Thank you.

David Loew: Thank you, Laura. On your first question, actually, the speed of -- let's call it like this, the speed of coming back is gradual in both regions. So, in the U.S., there has been a very slow ramp-up and same thing actually in Europe. So, it's clear that advanced is still struggling to really come back fully, and we have to observe now if they're going to be able to fix it. I mean, as you know, they have announced that by end of Q1, they expect it to be back. They are not clearly, fully back. So, we have to see what's going to happen in the next weeks or months to come. It's, of course, hard for us to know the details on this. I mean we would have to be a fly in the wall in their manufacturing site, which, of course, is not possible. So, it's hard to really speculate. We can only see what happens on the market and what they are telling to countries or distributors, that's all what we can observe. On the Cabometyx, on the neuroendocrine side, we have talked in the past about probably around EUR100 million opportunity, the ramp-up would be a first launch in Germany, and then we will get reimbursements that we have to get for in the payer markets where, for example, in France or Italy, et cetera, it can take some time to get reimbursed. And then it can probably ramp up with a typical, I would say, NET speeds, knowing that this is a slow-progressing disease, so it's not going to jump up from one day to the other. Patients are going to gradually progress, and then they're going to be switched. So, it's going to be a gradual ramp-up, I would say. But there is still a nice opportunity to patent exploration. So, we still have four years in front of us. So that's very nice opportunity if it gets approved. Thank you very much.

Operator: Thank you. [Operator Instructions]. We'll now take our next question. This is from Shan Hama from Jefferies. Please go ahead.

Shan Hama: Hi. Just a follow-up from me, if that's okay. Just are there any updates on Onovide's IPs? I think previously it was that IP should be into the 2030s. I think it might have been contingent on getting it officially settled. So, when do you expect IP to be challenged by generic manufacturers? And do you think you can ramp up sales until then? Thank you.

David Loew: Yes. Thank you, Shan. Our base case assumption is for the first line 2031, as we got orphan drug designation. So, it's actually beyond what we have communicated in the past because we got this orphan drug designation. But we also have method of use patents, which can go up to 33 and 36. So our base case is longer than the substance patent itself, which is 2027.

David Loew: So, if there are no more questions, this wraps up our call. Thank you very much, everybody, for attending. Goodbye.

Operator: Thank you. This concludes today's conference call. Thank you for participating, and you may now disconnect.