Hello, and welcome to Ipsen's Conference Call and webcast on year-to-date 2024 sales. I'll now hand you over to David Loew, Ipsen's CEO.
Good afternoon or good morning, everyone. Welcome to Ipsen's year-to-date and third quarter sales update call. As you just heard, I'm David Loew, Chief Executive Officer of Ipsen, and it's a pleasure to take you through the progress we are making this year. Please note that our presentation is available on ipsen.com. Please turn to slide two. 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 three. I'm going to take you through our brief presentation, and then our CFO, Aymeric Le Châtelier, and our Head of Research and Development, Christelle Huguet, will join me to answer your questions. Let's begin by taking a look at today's highlights. Please turn to slide four.
The highlights today center on strong growth momentum and further pipeline progress. Total sales grew by 8.6% in Q3 and by 9.2% in the first nine months, with notable performances that include Dysport and Bylvay. Our two biggest launches of the year, Iqirvo and Onivyde, are also on track. Turning to the pipeline, we're happy to achieve two European Union approvals on the same day last month, namely Iqirvo in second-line PBC and Kayfanda in Alagille syndrome. We also filed Cabometyx in the European Union for the second-line plus treatment of neuroendocrine tumors, following the publication of excellent results from the phase 3 CABINET trial. Please turn to slide five. Looking further at our sales performance, the growth of rare disease stands out, driven by the continued success of Bylvay, as well as the first time contribution of Iqirvo.
Neuroscience, dominated by Dysport, delivered a strong performance, while oncology has also been performing nicely this year, partially reflecting the growth of Cabometyx. I now turn to oncology in more detail. Please turn to slide six. Starting with Somatuline, sales were up by 5% in the third quarter. In the U.S., adverse pricing has persisted, though demand remains stable, with the effect of a loss of share offset by robust market growth. The anticipated penetration of the U.S. generic has been more limited than expected, and that may continue for the rest of the year. In Europe, we again took advantage of the generic supply issues. Cabometyx sales were up by 11% in Q3, with a strong volume performance in both first and second-line renal cell carcinoma.
Rest of world represents around a third of Cabometyx sales, and that region grew by 18% in the quarter, with a particularly good performance in Latin America. Decapeptyl sales were down by 5% in Q3, as we are seeing increased competition and pricing pressure in Europe, while in China, the market remains challenging. We continue to see underlying global volume growth, however, and we are anticipating more favorable conditions next year. Finally, Tazverik sales rose by 19%, despite a competitive environment in the third line indication, which is expected to intensify. To complete the focus on oncology, I'd now like to turn to the launch of Onivyde in first-line pancreatic cancer. Please turn to slide 7. The launch of Onivyde in first-line pancreatic cancer is on track, and we are making good progress with U.S. sales up by 26% in Q3.
We're clear about the significant potential of Onivyde over time, with NALIRIFOX having a favorable profile in comparison to the two other regimens being used. We have seen in many other cancer types that this needs time to play through, but we're encouraged to see that we have already performed well, especially in the top centers. Weekly demand has been growing, as you can see, and by the end of July, Onivyde's share of new patient starts in first line had already reached 7%. Indeed, nearly 300 U.S. physicians have initiated patient treatment with NALIRIFOX in twenty twenty-four, while we have delivered 24% sales growth in the top 25 accounts since launch. We believe the innovation this regimen brings to patients based on results from the first positive first-line metastatic pancreatic phase 3 trial in over a decade, differentiates it from other first-line treatments.
It's also worth noting that real-world overall survival data will likely read out in early 2027. Now, let's turn to the performance in rare disease. Please turn to slide eight. Bylvay continues to grow nicely, with sales in Q3 of 37 million EUR. In the PFIC indication, we have expanded the patient population in the U.S. and achieved more reimbursement in other markets, most recently in South Korea. The uptake in Alagille syndrome continues to grow in the U.S., and over time, we anticipate sales in Europe following the recent approval of Kayfanda in the European Union. Sales of Sohonos have proved more challenging and amounted to only 3 million EUR in the quarter. There have been a number of adverse factors affecting the low patient uptake, including the impact of recruitment into other trials.
The limited label and the lack of ex-U.S. approval also continue to affect the level of sales. I'd now like to complete the rare disease performance and move to the launch of Iqirvo. Please turn to slide 9. The launch of Iqirvo is on track. Following the U.S. approval in June, we delivered eight million EUR of sales, and we have consistently grown the number of reimbursed U.S. patients on therapy. Strong awareness is being generated through different channels, and initial feedback from doctors and patients have been very positive. In a market driven by efficacy, Iqirvo's excellent results of patients achieving a biochemical response versus UDCA alone, has been impactful on the growth of prescriptions.
We're achieving an excellent sales mix, with the vast majority of Iqirvo patients being second line treatment naive, with a large reservoir of patients still being uncontrolled on UDCA and eligible for Iqirvo treatment. Also, we're already seeing 70% of Iqirvo patients being treated at initiation between 100 and 170 ALP, which points to an attractive market opportunity. Encouragingly, more than 50% of covered lives are already covered in the U.S., and following the recent European Union and U.K. regulatory approvals, Iqirvo has already been launched in Europe, with reimbursement and sales in Germany recorded this month. Let's now complete the sales review with a focus on Dysport. Please turn to slide 10. The growth of Dysport is unrelenting, with sales up by 11% in the third quarter.
Aesthetics is performing well, with sales up by 18%, and we have seen continued growth in most territories, augmented by share gains in countries such as the U.S. and Brazil, despite an element of market softening in the U.S. European markets have remained robust with a good performance. In therapeutics, sales declined by 1% in Q3, primarily reflecting unfavorable phasing and inventory. Underlying dynamics remain attractive, however, with share gains in specialty, driving continued growth in most markets. Indeed, we are delighted with how well Dysport has performed overall this year, and we look forward to another year of growth in. That concludes the review of sales. Let's now turn to the pipeline. Please turn to slide 11. You can see a well-balanced portfolio across the therapy areas and phases of clinical development.
In addition, we anticipate a number of our preclinical assets entering phase one in the coming months. I will now pick out some highlights from the clinical pipeline. In oncology, we have five major ongoing clinical trials, with tovarafenib recently added to the pipeline in both first and second line pediatric low-grade gliomas. In rare disease, we have trials across liver disease and FOP, while in neuroscience, we look forward to aesthetic long-acting neurotoxin phase two data next year. Please turn to slide 12. The next two years, we'll see a number of key data readouts. In twenty twenty-five, we anticipate filing the tovarafenib FIREFLY-1 data, while we expect the readout from the pivotal FALCON phase two trial of fidrisertib in FOP.
2026 will be a very busy year for the pipeline, with several anticipated phase 3 data readouts, including for Tazverik, Iqirvo, and Bylvay, as well as migraine trial readouts for Dysport. Please turn to slide 13. Turning to financials and based on the performance in the first nine months of the year, we are today pleased to increase our full year guidance further. We now expect total sales to grow by more than 8% at constant exchange rates, as compared to our previous guidance of growth above 7%. Furthermore, we now anticipate a margin of more than 31% of total sales. Please turn to slide 14. In conclusion, our strategic success continues to deliver, and we're set for strong financial and pipeline results this year.
Our attractive top line continues to grow, driven by the powerful combination of our therapy areas, as well as the contribution from the recent launches. Our R&D organization is advancing the early and late stage pipeline well, and we look forward to many milestones to come, particularly in twenty twenty-six. And finally, we have increased our full year guidance again, driven by real momentum and our strategic progress. Please turn to slide 15. So Christelle, Aymeric, and I now have the time for your questions. Operator, over to you.
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 your first question. One moment, please. Your first question today comes from the line of Florent Cespedes from Bernstein. Please go ahead.
Good afternoon, Florent Cespedes from Bernstein. One quick question on 2025. As this year, your performance is a little bit better than expected, and driven by the better resilience of your key products. We're just wondering, how do you see the dynamic there with the new products growing, and also how, if you could give us a little bit of color, how do you see the impact on the operating margin, on the more pressure from generics and the launch of the recently launched products? Thank you.
Thank you, Florent. I mean, as you know, we are not giving 2025 guidance yet, so you have to be a bit patient, on this one. Clearly, as you have seen, we have updated our guidance on 2024, which is indeed better. Your question regarding the new products, as we laid out to you in the slides that I have just gone through, we are fully on track on Onivyde, on Iqirvo. I think the feedback that we're getting from the market is positive. So, we are also positive for 2025, where this dynamic is gonna continue.
Depending also on what happens a bit on the Ocaliva, where you have seen that the FDA has taken a bit more time to come back on the advisory committee, and where in Europe, Advanz has started the litigation against the EMA regarding the withdrawal of Ocaliva. It depends a bit what's gonna happen there as well, if that curve is actually gonna accelerate, if Ocaliva will be withdrawn, or if, you know, if Ocaliva does not get withdrawn or, you know, there will be a compassionate use, we would be on the pickup that we see now. In terms of operating margins, regarding generics, I can have Aymeric answer you to this question.
Yeah. So thank you, David. So we, we're not gonna provide 2025 guidance ahead of of February. As you know, in December last year, we, we guided for a, a progressive margin enhancement, which will be driven by all the new product and our ability to overcome the progressive erosion of somatostatin. I think you should expect that in 2025, we're gonna continue to invest in the pipeline, and you've seen the presentation from David on the pipeline, and we're gonna also continue to support the launches, which are also a very important part of the midterm future for Ipsen.
Thank you very much.
Thank you very much. Very clear.
Mm-hmm. Thank you.
Thank you. We will now take the next question, and your next question comes from the line of Shan Harmer from Jefferies. Please go ahead.
Hi, there. Just two from me, please. How do you expect the generics landscape for Somatuline to develop going into Q4, and then during 2025, assuming that it's very unlikely that the beats will continue to be driven by lower than expected erosion? Just a second question, please. Given the recent weak consumer demand with particular relevance to U.S., how are you viewing the aesthetics market for this quarter, especially with your partner? Thank you.
Thank you, Shan. On the generics, on somatostatin, I just would like to come back to what we said actually in our capital markets day in 2020. It is a very difficult-to-produce product, and this is basically what we're observing now, where we have seen Advanz not being able to supply correctly the European markets and where Cipla is also struggling now. We have to keep in mind that both of them are sourcing from Pharmathen. Pharmathen also is gonna start producing octreotide generic, which has been approved in the U.S. for Teva. So it's all coming from the same producer. But it's very hard for us to tell you, you know, with precision, are they gonna be able to fix those underlying problems, et cetera. I think that's a question you would have to ask to Pharmathen.
Of course, for us, you know, we are ready to supply somatostatin. We have added shifts. We see good demand. So that's the current situation. But we have to anticipate that at one point they're gonna potentially figure out how to improve their production. And as we have communicated in the past, we also anticipate a generic, a second generic entrance, probably mid next year, probably with Sun Pharma, launching, potentially in Europe and eventually also in the U.S. So that is included in our guidance. Now, of course, we have seen a better performance because we have seen these stockout problems. On the consumer demand, what we see with this part in aesthetic is that Galderma is gaining market share in the U.S., while the market has softened a bit.
But so we see good growth on this market for this part, and we're very pleased with it. Thank you, Shan. Next question, operator?
Thank you.
Thank you. Your next question comes from the line of John Priestner from J.P. Morgan. Please go ahead.
Hi, John Priestner from J.P. Morgan. Thank you very much for taking my questions. So two for me, please. The first one on Iqirvo sales. So they were slightly behind consensus estimates for Q3, and they continue to be broadly in line with the prescription trends. So is this a good metric that we can forecast off going forward, and how do you really see that launch trajectory developing next year? And then maybe another one on Iqirvo. So you said that you've got about 50% of U.S. lives covered now. So how do you really see the reimbursement landscape playing out in the U.S.? Do you expect insurance plans to cover both Iqirvo and Gilead's Livdelzi, or could it be that one product may get a preferred status? And I guess if it...
And it'd be useful to hear any kind of initial feedback you have from insurers. Thank you.
Thank you, John. So we have shown you in the slide the trajectory. You know, what we are observing in this market is that physicians are calling in the patients with their usual six-monthly visits because these patients are typically followed with visits every six months. And when they come in and the physician sees that they are not fully at control or, you know, for example, they are not responding well on either UDCA or Ocaliva, then they will initiate a change of treatment or the addition of treatment on Iqirvo. And you have seen, we were very pleased to see that actually we get the vast majority of naive patients. We get some switches from Ocaliva. Now, to your question, is that trajectory a good model for the future?
The answer would be yes, unless Ocaliva gets withdrawn, and then there could be an acceleration of that curve. Because, depending on what's gonna happen and the attitude of Intercept and Advanz, if they will give compassionate use or not, that could also be the case, because if they have their license withdrawn, they might actually tell physicians, "You need to switch them to another treatment." And there are other treatments now available, so I don't know if they would actually give compassionate use, to be honest. So that could accelerate that curve potentially. But we're not there yet. FDA has taken a bit more time to respond, and they are in this legal battle with Advanz. Ultimately, our assumption is that Ocaliva could get withdrawn. So but let's be patient, and let's see what happens there.
Regarding your second questions on the lives covered, we are pleased with the 50% of lives being covered. We anticipate that more lives will get covered. Is there gonna be, at one point, an insurance company asking to select one or the other? It's a bit hard to predict. We don't see that happening yet. I say yet, because in our forecast model, we have anticipated that some plans will perhaps insist on selecting one or the other. But, you know, there are some differences of these drugs, including, you know, the trial population that were in these drugs. So it's not a totally straightforward one to pick one or the other. So we have to see how this develops, but we have indeed, in our forecast guidance models, that there would be competition on... Coming from some plans.
Thank you, John.
Great. Thank you.
Thank you. Your next question comes from the line of Charles Pitman from Barclays. Please go ahead.
Hello, I'm Richard Kocher on behalf of Charles Pitman. I have one question. On Bylvay and Iqirvo, what are the initial feedback from physician on the launch? And how it is performing as compared to the initial expectations? Yeah, that's it.
Thank you, Richard. So I start with Bylvay. You have seen Bylvay progressing really nicely in PFIC and in Alagille. There is a very good reception of Bylvay, I have to say, because, you know, we have a product which is easier to take for patients with the capsules. When they grow older, you can also sprinkle it in chocolate mousse, chocolate sauce or apple mousse, for example, or you can also dilute it in a liquid. So that's certainly over the lifespan of a child an advantage. That was the reason why we went after Albireo, not Mirum. And we are pleased with the pickup that we see, and the physician feedback is very positive. On Iqirvo, very similar.
Physicians do understand that we have had a thirteen times improvement of the ALP values versus placebo. So they see the efficacy that the product is bringing to patients, which, in our clinical trial population, had very high levels of ALP. And so we get good market research feedback. We get good pickup and so we are pleased with the progress so far. Thank you, Richard.
Thank you. Oh, 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 will now take your next question, and your next question comes from the line of Laura Hindley from Morgan Stanley. Please go ahead.
Thank you. Laura Hindley from Morgan Stanley here. I have some questions on Decapeptyl. Could you just come back in a bit more detail on the dynamics that you're seeing with this product? Why do you expect more favorable conditions next year, and can we expect growth in Europe in 2025? And then, in light of these dynamics, are you still confident in the mid-single-digit CAGR at the 2027? Is there downside risk here? Thank you.
Thank you, Laura. Yeah. Basically, you know, what we have seen is underlying volume growth. Then on, you have to look at; there is, of course, market growth for the hormonal treatments because they are new agents. They are piggybacking on the hormonal treatments, and that actually prolongs treatment duration. So there is a push on longer treatment durations and some market share gain. In some other markets, you know, we have seen a bit more competition regarding market share, for example, Spain or in China, where some one-month treatments came in. So, but overall, globally, we see a clear dynamic on the underlying volume growth.
Now, regarding price, you have from time to time negotiation with payers that, then, for example, are decreasing somewhat, your price, which has just happened, for example, in France, but this is not every year. And then you also have sometimes effects from clawbacks, and these clawback effects, which are affecting the whole industry, they can impact on some of the drugs. In this case, it has been impacting Decapeptyl this quarter. So this is why we are confident on our midterm guidance, and we expect that we will see growth also in 2025. Thank you, Laura. Mm, okay, any more questions?
Thank you. There are currently no further questions, sir. I'll hand back to you for closing remarks.
Okay, this ends our call. Thank you for attending. Have a very nice day. Bye-bye.
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.