Hello, and welcome to Ipsen's conference call and webcast on Q3 2026 results. I will now hand you over to David Loew, Ipsen's CEO.
Thank you, operator. Good afternoon, everyone, and thank you for joining Ipsen's Q3 2026 update. Today, we will review our strong third quarter and year-to-date sales performance, the progress across our portfolio and pipeline, and the key milestones ahead. Please turn to Slide two. Before we begin, please take note of the forward-looking statements and risk factors described on this slide. Unless otherwise stated, growth comments during the presentation are at constant exchange rates. Please turn to Slide three. I will take you through today's highlights, our sales performance, full-year guidance, and late-stage pipeline before concluding. Aymeric and Christelle are also with us and will join for the Q&A. Please turn to Slide four. The third quarter again demonstrated the strength and breadth of Ipsen's growing by 26.7%. Year-to-date sales grew 24.6% at constant exchange rates, with both our core portfolio and Somatuline delivering growth above 24%.
Our core portfolio, which includes all medicines excluding Somatuline, grew by 24.2%, showing that the broader business is scaling strongly and increasingly driving Ipsen's performance. As a result, we are further upgrading our guidance today. We also advanced four major late-stage opportunities. Regulatory submissions are on the way for Dysport in chronic and episodic migraine. The ELSPIRE filing for an Iqirvo label update is underway. The POIESIS trial has recruited very well for navtemadlin, and the pivotal potravitug program is moving forward. Please turn to Slide five. Turning to sales performance, third quarter sales reached EUR 1.1 billion, growing 26.7% at constant exchange rates. Year-to-date sales reached EUR 3.364 billion, up 24.6%. All three therapeutic areas contributed strongly. In the quarter, oncology grew 17.7%, rare disease grew 88.6%, and neuroscience grew 23.1%.
Our core portfolio delivered EUR 793 million of sales in Q3, up 23.3%, and EUR 2.297 billion year-to-date, up 24.2%.
This balanced performance is important. Somatuline remains strong, while the core portfolio is now a powerful and broad-based growth engine in its own right. Please turn to Slide six. Looking at the year-to-date performance by medicine, oncology sales reached EUR 2.197 billion, up 16.3%. Somatuline grew 25.5% to EUR 1.067 billion, benefiting from continued generic lanreotide shortages and supply constraints, mainly in North America, alongside solid demand in rest of world. Cabometyx grew 15.6% to EUR 523 million, supported by solid performance across geographies in renal cell carcinoma and a growing contribution from neuroendocrine tumor launches in Europe. Onivyde sales are flat despite the decrease in the U.S. in the third quarter due to competition, while the Otcenda launch is underway. Rare disease doubled to EUR 498 million. Iqirvo reached EUR 283 million, up 170.8%. Bylvay reached EUR 189 million, up 43.8%, as we see continued momentum in our launches.
Neuroscience sales reached EUR 669 million, up 18.8%, led by Dysport Aesthetics, which grew 25.6%, driven mainly by Europe, including favorable order phasing in the third quarter and in Rest of World, with a strong performance in Ipsen territories. Dysport Therapeutics grew 9.2% despite unfavorable shipment phasing in Rest of World in the third quarter. Please turn to Slide seven. Based on the strength of our year-to-date performance and the momentum across the business, we are further upgrading our full-year 2026 guidance. We now expect total sales growth of around 23% at constant exchange rates compared with more than 20% previously, and a core operating margin of around 39% of sales compared with above 37% previously.
This upgrade reflects the continued strength of the top line driven by the strong double-digit growth of our core portfolio, despite headwinds in Onivyde and Somatuline still growing this year despite generic launch in Q4.
Please turn to Slide eight. This slide captures the scale of our late-stage opportunity. Across oncology, rare disease, and neuroscience, we are advancing multiple differentiated assets towards blockbuster potential. In oncology, navtemadlin is in phase III for myelofibrosis, with the POIESIS readout expected in 2027. IPN60340 is advancing in first-line unfit AML. In rare disease, Iqirvo continues to expand its opportunity in PBC and potentially PSC, while potravitug is moving into pivotal development for post-transplant nephropathy. In neuroscience, Dysport has delivered positive phase III results in both chronic and episodic migraine, and regulatory submissions are on the way. corabotase is progressing across aesthetics and therapeutics with several important readouts ahead. Each of these major opportunities has the potential to exceed $1 billion in sales if successfully developed, approved, and commercialized. Collectively, they can reshape Ipsen's growth profile and provide substantial new sources of growth beyond today's portfolio.
Please turn to Slide nine. The breadth of our pipeline is a major strategic advantage. We now have late-stage and earlier-stage programs across all three therapeutic areas, combining internal innovation with disciplined external innovation. In oncology, we are building depth in solid tumors and hematology with more phase I assets to come into the clinic over the coming years. In rare disease, we are expanding beyond liver disease into post-transplant nephropathy. In neuroscience, we are leveraging our expertise across aesthetics, migraine, spasticity, and cervical dystonia. This is a focused pipeline with multiple opportunities capable of becoming meaningful new medicines. Please turn to Slide 10. The next 18 months contain several important milestones that can further validate the value of our pipeline. In oncology, the key event is the phase III POIESIS readouts for navtemadlin in myelofibrosis in 2027, alongside FIREFLY-2 for tovorafenib.
In neuroscience, we expect phase II readouts for corabotase across therapeutics, followed by the first phase III aesthetics readout in 2028. In rare disease, we are progressing potravitug into pivotal development. These milestones give us multiple shots on goal and the potential to unlock several blockbuster opportunities. Please turn to Slide 11. To conclude, we are delivering on our 2026 priorities, strong financial performance today while building the next wave of growth. We have delivered solid double-digit growth supported by our core portfolio, resulting in further upgrade to our full-year guidance. At the same time, we are advancing an expanded portfolio of late-stage assets across our three therapeutic areas and preparing for the next wave of major launches. Over the next 18 months, we have multiple important catalysts across programs with blockbuster potential. We also retain significant financial firepower to further strengthen our portfolio through disciplined external innovation.
Together, we are well-positioned in our ambition to bring forward new medicines with blockbuster potential and make a meaningful difference for patients. Please turn to slide 12. Thank you. We will now open the call for questions.
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. Thank you. We will now go to our first question. One moment, please. The first question today comes from the line of Victor Floc'h from BNP Paribas. Please go ahead.
Hi. Thanks so much for taking my question. Maybe just two on Toxin, please. First, on Dysport in migraine, is there anything you could share from your type B meeting with the FDA? When should we expect to see the full phase III data as well? Secondly, on corabotase, Galderma has recently signed new arbitration related to corabotase. Is there anything you can say about that? How do you see any risk that this could delay or impact your ability to launch assuming positive phase III data in 2028? Thank you very much.
Thank you, Victor. On Dysport migraine type B meeting with FDA went very well. We will inform you once the FDA accepted our filing. You just need to be a little bit patient, but the filing activities are on the way. On the phase III data, we have submitted to an upcoming conference. We will also inform you as soon as we have the formal acceptance of the submission, and then we can give you the precise date. You can count on that we are also planning to have an investor call at that moment. Regarding your second question on corabotase on the arbitration, which has been launched by Galderma. As you remember, we won the arbitration on the R&D collaboration, which was relating to the contract of 2014. This arbitration is based on an older contract, 2007, on the distribution agreement.
I can't really speculate on the outcome of this. As you know, arbitrations take about two years. We have to just be patient and then see what the readout is of this arbitration.
Thanks very much.
Thank you. Next question.
Thank you. Your next question today comes from the line of Benjamin Jackson from Jefferies. Please go ahead.
Great. Thank you for the question guys . Just two from me, if I can squeeze them in. The first, just to follow up on the migraine Dysport side of things. Just interesting to know the level of confidence that you have about the chronic migraine setting. I know that the episodic gives you a lot more space versus the competitors. But specifically for chronic migraine, do you think you've got a differentiated product in that segment, too? Is that something we should be really thinking about and working on, in terms of those comparisons? Secondly, just interested on the Dysport Aesthetics for the quarter. Obviously, strong quarter.
How much of that is due to the solid underlying you're seeing both in your own territories as well as Galderma territories, versus how much is a phasing effect given that the shipment timing can be a little bit uncertain? I'll jump back in the queue for a couple more.
Very good. Thank you, Ben. On migraine, our data in chronic is very strong. You will see it at the conference. Of course, I cannot speculate on doing cross-study comparisons. If you want to do that, you can of course do that. But you have to just be a little bit patient on seeing the data, but the data is looking very good. On Dysport, the Ax, we had strong growth in both, in Galderma territories, but also in Ipsen territories, we had very strong growth. I don't know, Aymeric, do you want to comment on phasing effects?
No. I think you said it, the performance is both a combination of the Galderma performance. They just released their numbers today, so you've seen the strong dynamic. There is always some phasing of shipment when you look geography by geography, especially the U.S., which has a weaker Q3 for us. But what is really important, and David was mentioning it, is that the strong performance of our Ipsen Ax business, which is clearly on a very strong momentum this year. Part of that business is in Middle East, and, as you know, we were worried about the impact of the situation in Middle East at the beginning of the year. It looks like it's a very strong demand and a very strong business in that region.
Thank you.
Thank you.
Thank you. Your next question today comes from the line of Xian Deng from UBS. Please go ahead.
Hi, thank you for taking my questions. So two, please, as well, and both on Somatuline, please. So the first one is just wondering, given Amneal's approval of Somatuline generics in the U.S. So of course this is early days, so just wondering if you could comment on what have you seen in terms of the market space with the competition. Then if we look at consensus for next couple years, consensus are modeling high teens erosion for the next few years. So of course, this is early days, so just wondering if you think that's a reasonable erosion rate from what you've seen to date. Then the second question is related to that. So given Somatuline so far has given a very attractive margin uplift. So just wondering, if Somatuline starts to erode as Amneal start to come in.
Wondering how we should actually think about margin if we look at your previous kind of 2023 to 2027 midterm guidance of 32%. Just wondering if that is kind of a good proxy in the midterm in the next couple years once Somatuline is a bit more normalized. Thank you.
Yeah, thank you, Xian. On Amneal, as you say, it is very early day. We see a gradual pickup, I would say. As I said, it is very early in the mix, so we have to just see how much they can really deliver. As we said in the past, it is a very difficult to produce product. We stick to what we have said, that we anticipate the gradual erosion of Somatuline over time. I do not go into commenting the consensus. What we have said is that we see a gradual erosion in the future, so nothing changes in that sense. Regarding the margin for the future, I will let Aymeric comment.
Yeah. Thank you for the question on the margin. I am not going to provide today the guidance for next year. As we indicated before, clearly 2026, as you see our guidance to 39% is, as you mentioned, an exceptional level fueled by the very high level of Somatuline. We should expect that clearly the margin are going to go down in 2027. This is due to the mix, and, as David said, the erosion of Somatuline will clearly have a negative impact on the margin. I think we should also factor all the investment for the launch, and the full development, especially in the Somatuline, but also the migraine, as we expect an approval next year for migraine.
All of that, I think that the level of margin should still be pretty significant because we are starting from a very strong base as compared to your reference in 2023, with a much stronger core portfolio, which we see will continue to deliver also a very solid growth in the midterm.
Thank you.
Thank you. Your next question today comes from the line of Harry Sephton from RBC. Please go ahead.
Brilliant. Thank you very much for taking my questions. I have two, please. The first one on Kartos. MDM2 inhibitors have a bit of a disappointing clinical history. What makes you confident in the data that you have seen so far for this asset, especially on the potential cytopenia risks, with the mechanism that we have seen historically? My second question is how do you think about the opportunity in lower ALP patients for Iqirvo? The label already seems to broadly incorporate these patients. How do you think about the potential step-up when you get the lower ALP adds to the label? Thank you.
Yeah. Thank you, Harry. On MDM2, you are right. In the past, these MDM2s were struggling to show convincing results. This is why Kartos has actually gone back to the bench and looked at how to optimally dose an MDM2 in relationship to the cell cycle of a cancerous cell. They have spent almost three years in preclinical models to optimize this, and then subsequently went into the clinic. What they have seen is very convincing results in a later line setting, in myelofibrosis. Which then led to a phase III in a last line setting.
When they saw combination results, because they conducted the phase II in combination with Ruxo, they found the response is so convincing that they actually stopped this late-stage trial, and they went immediately into combination into the non-optimal response setting, where after 16 weeks, Ruxo patients who do not get optimal response get added on the navtemadlin. With the data that we have seen, this is what convinced us that this drug has a potential promising future. We have just now finished the recruitment, and we are advancing this trial very well. We can anticipate that in H2 next year, we should see results. Fingers crossed this is going to work. Regarding Iqirvo, on the ELSPIRE population, as you remember, the above 1.67 population is about 40,000, the below is about 30,000. It is a very significant expansion of the pool.
Formally speaking, the label allows the physician to already prescribe, because it is not that it is excluded from the indication, but we are filing the data to be included in the clinical trial section so that we can also fully promote this by our field force. We might already see some spontaneous uptake that we have observed already with the launch. About 20% of our sales come already from below 1.67. This could start to accelerate once the data is out with spontaneous uptake. Then we should be able to promote it once we have it formally in the label. This is quite a significant upside potential. This is why we have also changed the guidance on Iqirvo, you remember, from the above EUR 500 million to now EUR 1 billion.
Thank you.
Thank you. As a reminder, if you wish to ask a question, please press star one and one on your telephone. That is star one and one to ask a question. We will now go to the next question. Your next question today comes from the line of Richard Vosser from JPMorgan . Please go ahead.
Hi. Thanks for taking my question. One just back on Somatuline, just ex-U.S., if you could give us an update on how you're seeing generics there. I think Amneal are talking about having enough supply to launch ex-U.S. What's your thoughts there and maybe a latest update around how you're seeing some of the other generics coming back in 2027? Second question, just on the myelofibrosis competitive environment, how are you seeing some of the competitive agents, maybe pelabresib from Novartis, fitting in and competing with navtemadlin? Apologies for the pronunciation, but the Kartos product. How do you see that? Thanks very much.
Yeah. Thanks a lot, Richard. On Somatuline ex-U.S., you have seen that our sales are relatively flat. While we see in some markets still a little bit of advance being shipped, not enormous amounts but just a little bit. We could see Amneal in the future enter in Europe, but they haven't gotten the approval yet. Let's see already what they can deliver in the U.S. I would say for the moment it's the same thing on Europe. We assume a gradual erosion over the time. Nothing really new here. On myelofibrosis and the difference between pelabresib and navtemadlin, I can ask Christelle to answer this.
For sure. Yes. Thank you, David. Thank you, Richard, for your question. What we know about pelabresib today is that in the first phase III MANIFEST-2, the study did not achieve the statistical significance on the total symptoms score endpoint, and similar results on prior studies. There is an ongoing MANIFEST-3 study that has selected patient with a higher baseline of total symptoms score threshold and a larger sample size. We will see the result of that study. It's ongoing. As David said earlier, our POIESIS study has enrolled extremely well and is progressing, and we are awaiting the results, of course, and we'll see how they pan out. From POIESIS-2, we have seen that with navtemadlin both the spleen volume reduction and the total symptom score at 50 gave us really good response at week 24.
We are very encouraged by the strong response of navtemadlin on top of Ruxo. Thank you for your question.
And perhaps just to add from a marketing point of view, in case Novartis would have a successful trial, I think there is going to be a debate if navtemadlin works. Should you actually do doublet right from the start, or should you do it sequentially because not all patients are going to need a doublet, and of course, it comes with more side effects, et cetera, when you do doublet. So, I think we will have to observe what the results are going to be. These are relatively slowly progression elderly patients. So I am not sure that if a first-line trial would come and wouldn't demonstrate overall survival, that everybody would go to combination therapy. I think it might be more likely actually that they go to a sequential therapy.
Thanks.
Thank you. There are currently no further questions. I will hand the call back to you.
Thank you very much, everybody. That concludes our call. Thank you. Have a good afternoon.
Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.