Half Year 2026 Ipsen SA Earnings Call
Speaker #2: Thank you, operator. Good afternoon, everyone, and thank you for joining IPSEN's H1 2026 results presentation. Today we will review our first half performance, the progress we are making across the business, and the key milestones ahead.
Speaker #2: Please turn to slide 2. 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.
Speaker #2: Please turn to slide 3. I will start with the business update. Aymeric will then cover the financial update. Chrystal will take you through the R&D progress, and Mary will cover the commercial update.
Speaker #2: I will then return for the conclusion before we open the call for questions. Please turn to slide 4. Let me start with the business update.
Speaker #2: Slide 5. The first half of 2026 was marked by excellent financials and progress on our strategy to accelerate growth of key medicines and expand the pipeline.
Speaker #2: We posted strong numbers, with total sales growth at 23.5% at constant exchange rates and a 38.6% core operating margin. The late-stage pipeline is delivering, with three positive Phase III readouts and three late-stage trials underway.
Speaker #2: The pipeline has been further bolstered as we announced two later-stage clinical acquisitions. Finally, based on this strong first-half performance, we are upgrading our 2026 guidance.
Speaker #2: Aymeric will provide more details in this section. Slide 6. Turning to sales performance, total sales reached 2.2 billion in the first half, growing 23.5% at constant exchange rates.
Speaker #2: All three therapeutic areas contributed positively. Oncology grew 15.6%, rare disease grew 108%, and neuroscience grew 16.6%. Importantly, total sales excluding somatoline grew 24.8%, demonstrating the breadth of growth across the business.
Speaker #2: Please turn to slide 7. Starting with oncology H1 sales grew 15.6% to 1.45 billion. Somatoline delivered 686 million, supported by performance in the US and Europe, ongoing generic laneratide supply constraints, and growth in rest of the world.
Speaker #2: Cabometics reached 351 million, driven by increasing share in renal cell carcinoma, and the contribution from the NET launch in Germany. Rare disease delivered a very strong first half with sales of 305 million, more than doubling year on year.
Speaker #2: IQUORBO reached $173 million, driven by higher patient numbers in the US and strong launches across European countries. Billway reached $120 million, reflecting strong growth in PFIC and Alagille in the US and Europe, with increasing contribution from the rest of the world.
Speaker #2: Turning to neuroscience, H1 sales grew 16.6% to €434 million. Aesthetics delivered €257 million, up 19.6%, with sustained growth across North America and Europe, and favorable shipment phasing in certain Rest of the World countries.
Speaker #2: Therapeutics reached €170 million, up 13.8%, with double-digit growth in the US and Europe, partially offset by tender phasing in the rest of the world. Please turn to slide 8.
Speaker #2: I wanted to highlight the evolution of our late-stage pipeline. We have now delivered three positive phase three readouts, two for this port in therapeutics across episodic and chronic migraine, both showing very strong results, and one for IQUORBO in PBC through the Elspire studies.
Speaker #2: Both assets, IQUORBO in PBC and this port in therapeutics, have blockbuster potential. At the same time, we're advancing three important late-stage assets: Corobotas in global alliance, Elafibrinor in PSC, and IPN 6340 in AML, reinforcing the depth and breadth of our internal pipeline.
Speaker #2: Together, this progress demonstrates that we are not only delivering strong near-term performance but also building the next wave of growth through disciplined execution across our priority therapeutic areas.
Speaker #2: Please turn to slide 9. Let me, lastly, touch on the two recently announced transactions, which are aligned with our strategy to build sustainable growth through focused external innovation.
Speaker #2: With CARTOS Therapeutics, we're adding naftamadoline, a Phase 3 oral MDM2 inhibitor for myelofibrosis, strengthening our hemato-oncology pipeline. With MEMO Therapeutics, we're adding Protravitoc, a first-in-class anti-BK polyomavirus antibody for post-transplant nephropathy, strengthening our rare disease pipeline.
Speaker #2: Both assets address areas of high unmet need and each has Blockbuster potential, subject to successful development and approval. With that, I will hand over to Aymeric for the financial update.
Speaker #2: Please turn to slide 10.
Speaker #3: Thank you, David. I will now take you through the financial update for the first half, including our P&L performance, cash flow performance, and also our upgraded 2026 full-year guidance.
Speaker #3: Please turn to slide 11. As you can see, we delivered another very strong set of financial results in the first half, across sales, profitability, and cash flow generation.
Speaker #3: Total sales reached 2.2 billion euros, growing 23.5% at constant exchange rates. Core operating income increased even further, by 28.8% to 845 million euros, while free cash flow was also very strong, at 652 million euros, up 34.9% year over year.
Speaker #3: And consequently, after the announced CARTOS and MEMO acquisition, we will still have more than 2 billion euros of pro forma firepower for external innovation, based on net debt including contingent liability and commitments at two times EBITDA.
Speaker #3: Let's go into the detail of those financials on the following slide. Please turn to slide 12. Starting with the P&L to core operating income, total sales reaching €2,190 million, up 20.4% at current exchange rate, including an adverse impact of currency for 3.1 points.
Speaker #3: Gross margin increased by 19% to reach 85.1% of total sales, compared with 86.1% last year. This reflects mainly lower other revenues due to fewer milestones received versus 2025, despite better cost of sales due to favorable product mix.
Speaker #3: HDNA expenses increased by 8.4%, reflecting the higher commercial investment to support launches, to reach around €600 million, and improved significantly as a percentage of total sales to 27%, compared to 30.8% last year.
Speaker #3: R&D expenses increased by more than 10% to over €400 million, due to continued investment to strengthen the internal pipeline, mainly in neuroscience for Corobotas and early-stage oncology assets.
Speaker #3: As a result, the core operating margin improved by 2.5 points to a record level of 38.6% of total sales. Please turn to slide 13.
Speaker #3: Cash flow generation was also very strong in the first half. Free cash flow increased by almost 35% to 652 million euros, driven by higher EBITDA, up 27%, and discipline management of capital expenditures and working capital.
Speaker #3: Net cash reached €1 billion, an improvement of €445 million versus December 2025, after limited investment—only €40 million—related to regulatory and commercial milestones, and the proceeds from the sale of equity investment shares, and after payment of dividend for €132 million.
Speaker #3: Based on that level of net cash at the end of June, and as I said on the pro forma basis, after the announced acquisition of CARTOS and MEMO, we will have more than 2 billion euros of remaining firepower for external innovation.
Speaker #3: Let's now turn to the guidance for 2026, and please turn to slide 14. Based on that solid momentum and the strong first half performance, we are upgrading today our full-year 2026 guidance.
Speaker #3: First, on sales, we now expect growth of more than 20% at constant exchange rates, as compared to 13% in our initial sales guidance. This assumes stronger growth for Somatuline, with the entry of lanreotide generics later in the second half.
Speaker #3: We also expect higher growth across the rest of the portfolio, notably driven by Bilvae, Icurvo, and Dysport, but also an higher contribution from our new product, Ojanda.
Speaker #3: We are also upgrading our core operating margin guidance by 2 points, from the prior level of greater than 35% to more than 37% of total sales, despite the expected dilutive impact from the planned acquisition of CARTOS Therapeutics.
Speaker #3: This improvement is driven mainly by the higher level of sales, but it also factors in additional R&D expenses and pre-launch preparation expenses for Dysport in migraine.
Speaker #3: With all of that, I will now hand over to Christelle for the R&D update. Please turn to slide 15.
Speaker #4: Thank you, Aymeric. If you would please turn to slide 16 and our pipeline. H1 delivered strong pipeline momentum across all three therapeutic areas, reflecting a clear progress against our strategy.
Speaker #4: In oncology, momentum is building across late-stage and early-stage assets, Ojanda continues in first-line pediatric low-grade glioma with Firefly 2. The eviction 3 study is open for IPN 6340, and 3 phase 1 programs are advancing well.
Speaker #4: In rare disease, we made important progress with a positive ELSPIRE phase 3B data for Icurvo in a PBC population that remained symptomatic on standard of care.
Speaker #4: We also opened LSCOPE, the first global Phase 3 trial in PSC. In biliary atresia, the topline BOLD readout did not meet the primary endpoint, reinforcing the complexity of the rare pediatric liver disease that is biliary atresia.
Speaker #4: In neuroscience, Dysport delivered positive Phase 3 data in both chronic and episodic migraine. While Cabaretas continues to expand and accelerate, with the Phase 3 LOURA trial open in glabellar lines, and the broader six-indication program advancing across aesthetic and therapeutic indications.
Speaker #4: Taken together, this is a pipeline with real breadth and increasing depth. Please turn to slide 17. This is an important achievement for Dysport and reflects the strength of IPSEN's neurotoxin heritage and expertise.
Speaker #4: The two Phase 3 trials, CBEYOND and EBEYOND, both showed strong results and met their primary endpoint of reducing monthly migraine days versus placebo. This makes Dysport the first botulinum toxin to deliver positive Phase 3 results in both episodic and chronic migraine; the episodic results are particularly meaningful.
Speaker #4: As it is the first phase 3 trial of a botulinum toxin to show a statistically significant reduction in monthly migraine days in this larger patient population with significant unmet need.
Speaker #4: Dysport was well tolerated, with safety consistent with its known profile. In a condition that affects nearly a billion people worldwide, these data drive confidence in Dysport's potential as a differentiated preventive treatment for a broad migraine population, and support regulatory submissions in the second half of 2026.
Speaker #4: Please turn to slide 18. Our third positive phase 3 readout this month was the phase 3B ELSPIRE trial evaluating Icurvo 80 milligram versus placebo, in patients with PBC with ALP levels were between 1 and 1.67 times the upper limit of normal, and/or after UDCA treatment.
Speaker #4: The results were impressive, with 85% of patients treated with Icurvo achieving ALP normalization, compared with 23% on placebo, with a highly significant p-value below 0.0001.
Speaker #4: This is meaningful because ALP normalization is increasingly recognized as an important treatment goal in PBC, and it is associated with improved long-term prognosis and slower disease progression.
Speaker #4: ELSPIRE reinforces Icurvo's clinical profile and supports the opportunity to treat a broader group of eligible second-line PBC patients. The data will be presented later on this year at the scientific congress, during the second half.
Speaker #4: Please turn to slide 19. Looking ahead, in neuroscience, later this year, we expect proof of concept data from the stage 2 of our Lantic trial for Corobotas in two further aesthetics indication for headlines and lateral canthal lines.
Speaker #4: In 2027, we expect therapeutics proof of concept data in two indications followed by the first aesthetic phase 3 readout in 2028. In oncology, we expect top-line data for Ojanda in first-line pediatric low-grade glioma in 2027.
Speaker #4: Please turn to slide 20. Now looking at our pipeline expansion. Let's take a look at the science behind our two recent late-stage acquisitions. Starting with CARTOS Therapeutics, NAFTEMEDLIN is an oral MDM2 inhibitor in development for myelofibrosis.
Speaker #4: The global Phase 3 POESIS trial is ongoing, evaluating naftemadlin as an add-on therapy to ruxolitinib, with more than 600 patients across 250 sites, and we expect top-line data in 2027.
Speaker #4: The goal here is to improve spleen and symptom responses in suboptimal responders to achieve a clinically meaningful response. The Phase 1b/2 data with NAFTEMEDLIN showed improvement in spleen volume and total symptom score, together with reductions in driver variant allele frequency and bone marrow fibrosis, supportive of potential disease modification.
Speaker #4: Now turning to MEMO, Potravitor is a first-in-class monoclonal antibody targeting BK polyomavirus in kidney transplant recipients. The immunosuppression regimen required to ensure successful and durable organ transplant function can trigger the reactivation of latent viruses like the BK polyomavirus, leading to associated nephropathy that damages the new kidney.
Speaker #4: Potravitor blocks viral attachment and cellular entry, preventing reinfection and viral replication, with the aim of preventing or resolving BK virus-associated nephropathy where there are currently no approved treatments.
Speaker #4: The totality of evidence from the Phase 2 Safe Kidney 2 trial supports the initiation of a pivotal Phase 2/3 trial later this year.
Speaker #4: I will now hand over to Mari to cover the commercial update. Please turn to slide 21.
Speaker #5: Thank you, Crystel. I will now cover the commercial update, focusing on the growth opportunities created by our advancing pipeline and recent portfolio progress.
Speaker #5: Please turn to slide 22. Let me begin with Dysport in migraine. As you will have seen, we recently reported positive BEYOND Phase 3 results in both the chronic migraine CBEYOND trial and the episodic migraine EBEYOND trial.
Speaker #5: We are very encouraged by these results, and we believe migraine represents a potentially significant growth opportunity for Dysport. Today, the global botulinum toxin market for therapeutics stands at approximately $4 billion, with chronic migraine being a large and growing segment, accounting for around 40% of market value.
Speaker #5: We expect Dysport to gain share in this growing segment. Then, the EBEYOND results also support the potential use of Dysport in episodic migraine. This would considerably broaden the patient population that may benefit.
Speaker #5: While we are fully assessing the clinical, regulatory, and commercial implications, these results have the potential to meaningfully expand the use of Dysport into migraine and support its strong growth potential over time.
Speaker #5: Pending regulatory approvals, we expect to launch Dysport in the migraine indications in the second half of 2027. So taken see Dysport as a compelling overall strategic opportunity for IPSEN.
Speaker #5: Please turn to slide 23. Next, I will discuss Icurvo and our recent positive Phase 3 ELSPIRE data in PBC. As a reminder, ELSPIRE was designed to complement our original Phase 3 Elective study by evaluating patients with ALP levels between 1 and 1.67 times the upper limit of normal.
Speaker #5: So taken together, elective and ELSPIRE now provide clinical evidence for Icurvo across a broad spectrum of second-line PBC patients. A key point to note is that the current US and EU regulatory approvals for Icurvo are broad, and do not specify an ALP threshold, meaning patients with ALP levels between 1.1 and 1.67 or the ELSPIRE population are already included within the approved indications.
Speaker #5: As to the patient population, over the past couple of years, while we've had good uptake and penetration of the PPARs for PBC patients, strong opportunities still remain.
Speaker #5: In addition to the approximately 30,000 US patients with ALP levels above 1.67, we estimate a further 20,000 PBC patients in the ELSPIRE population. We continue to focus on the importance of striving for deeper biochemical responses and ALP normalization as a treatment goal.
Speaker #5: Our emphasis is now on translating the full ICURVOTM dataset into clinical practice through continued physician and patient education, and supporting appropriate treatment across all eligible second-line PBC patients.
Speaker #5: Commercially, we upgrade our peak sales estimate for Icurvo to $1 billion in PBC, based on our confidence in the continued growth and broader adoption of Icurvo across eligible PBC patients.
Speaker #5: Please turn to slide 24. Moving next to external innovation, I will first start with Cartos and navtemadalin. As announced a few weeks ago, we entered into an agreement with Cartos for navtemadalin, an investigational oral MDM2 inhibitor for myelofibrosis.
Speaker #5: Let me briefly cover the patient and commercial opportunity we see here. Myelofibrosis is a serious and progressive blood cancer that primarily affects older adults and is associated with significant symptom burden, splenomegaly, reduced quality of life, and shortened survival.
Speaker #5: In the United States, we estimate there are approximately 6,000 newly diagnosed intermediate- and high-risk MF first-line patients each year. Over the past decade, bruxolitinib has become the standard of care for these MF patients.
Speaker #5: However, despite its important role significant unmet need remains. Many patients experience a decline in treatment over time, with up to 70% estimated to become suboptimal responders.
Speaker #5: We'll only partially benefit and persistent disease burden highlighting the need for treatment options that can deepen and expand response. This is where NAVTEMEDALIN has the potential to play an important role.
Speaker #5: The ongoing Phase 3 POSITIVE study is evaluating navtemadalin in combination with ruxolitinib in patients with a suboptimal response to RUX. The study uses FDA-aligned co-primary endpoints of spleen volume reduction and symptom improvements at week 24.
Speaker #5: These are endpoints that are well established as cleanly meaningful measures of treatment benefit in myelofibrosis. Looking ahead, we expect to close the transaction in the third quarter of this year, and subject to successful phase 3 results, and regulatory approvals, see potential for launch as early as 2028.
Speaker #5: So, in summary, navtemadalin adds a late-stage hematology-oncology asset to our pipeline, with the potential to address a significant unmet need and further strengthens our Ipsen growth outlook.
Speaker #5: Please turn to slide 25. Looking next to memotherapeutics, empotravatac. With this acquisition, which we completed just last week, we are adding empotravatac, a phase 2/3 ready monoclonal antibody targeting BK polyomavirus, further extending our rare disease pipeline beyond liver diseases.
Speaker #5: We see an exciting opportunity here to make a major advance for kidney transplant patients. Approximately one quarter of kidney transplant recipients—if less than controlled, this can lead to BK VAN, which can then induce graft damage, loss of kidney function, and ultimately, for some, graft failure.
Speaker #5: Today, unfortunately, there are no approved therapies specifically targeting BK virus. So clearly, we see a compelling opportunity. More than 28,000 kidney transplants are performed annually in the United States, and patients with BK viral loads above 5,000 international units per mL—and even more so above 10,000 international units per mL—are considered at higher risk of graft complications and represent a clearly identifiable patient population.
Speaker #5: These patients are managed through a relatively concentrated network of specialist transplant centers, with well-established monitoring and treatment pathways enabling efficient patient identification and engagement.
Speaker #5: Hence, we are looking forward to further progressing with empotravatac in this important area. So stepping back, the recent positive phase 3 data for Dysport and chronic and episodic migraine, the positive phase 3 ELSPIRE results for Icurvo and PBC, and with the addition of NAVTEMEDALIN and empotravatac, we have further strengthened both the near and the longer-term outlook of our portfolio.
Speaker #5: Together, these opportunities reinforce our confidence in the growth potential of our global business across oncology, neuroscience, and rare diseases. With that, I will hand back to David.
Speaker #5: Please turn to slide 26.
Speaker #1: Thank you, Mary. Let me now conclude with the key takeaways from today's presentation. Slide 27. To conclude, H1 2026 shows IPSEN delivering strongly on its strategy to accelerate growth of key medicines and expanding the pipeline.
Speaker #1: We delivered very strong first-half sales growth, upgraded our full-year guidance, and maintained strong cash generation, giving us the flexibility to keep investing behind future growth.
Speaker #1: At the same time, the pipeline has advanced materially. We now have three positive Phase 3 readouts across Dysport in migraine and our CORBO and PBC, alongside a broader late-stage pipeline with both internal and externally sourced assets.
Speaker #1: Commercially, the opportunity set is expanding. Icurvo, Navtemedalin, and Empotravatac each have significant potential, while we continue to evaluate the full potential of Dysport in migraine following positive Phase 3 data.
Speaker #1: So the message is clear: IPSEN is delivering today, accelerating growth from key medicines, and expanding the pipeline to generate sustainable growth beyond 2027, with several potential blockbusters to come.
Speaker #1: Please turn to slide 28. Thank you. We will now open the call for questions.
Speaker #2: Thank you. To ask a question, please press star 11 on your telephone, and wait for your name to be announced. Do we throw your question?
Speaker #2: Please press star 1, and then 1 again. We will now take our first question from the line of Jihan Li from Barclays. Please go ahead.
Speaker #3: Oh, hey. This is Jihan from Barclays. Congrats on the quarter, and thanks for taking our questions. So I have two, please. So the first one is on symmetry.
Speaker #3: So, I'm not sure if I heard it correctly, but earlier on the call you said you expect stronger growth for Symmetry with an entry of generics in the second half.
Speaker #3: So, based on the Amnious second quarter earnings slides today, they still guided us for the quarter launch. So I just wanted to better understand, what is your rationale behind this stronger growth?
Speaker #3: And could you please help us to understand, you know, the symmetry in generics competitive assumptions that embedded in your second half outlook? And also separately, with the existing mid-term targets, increasingly outdated.
Speaker #3: So when should we expect an update? Maybe a CMV likely next year? And my second question is on Billway. So the second quarter sales, we're slightly below the expectation.
Speaker #3: So just curious, like, could you please discuss the underlying demand trends? And also your expectations for the growth from here? And also the recent phase 3 boat BA12 failure.
Speaker #3: Just curious. Did you observe any, you know, positive signals in subgroups that could potentially support further analysis? Thank you so much.
Speaker #1: Thank you, Yan Li. On Zymetalin, we do, in our guidance, indeed assume the Amnio launch. So that's included. The reason why we think that Zymetalin, despite potentially losing a little bit of volume, is actually going to see attractive sales still in the second half, is that there is an effect on the pricing that we were able to take back, the gross to net.
Speaker #1: And that translates into a higher ASP, in the US, which over time gives a positive benefit in the second half. So that explains that comment.
Speaker #1: On the midterm, I'll let Aymeric answer.
Speaker #4: Yes. So, I think on the midterm guidance—your question was, do we plan a capital markets day? I think, as you said, we are highly confident that the midterm outlook to 2027 we are fully on track to deliver and even exceed.
Speaker #4: I think that for the timing of the capital market day, I think it's too early to call. We'll inform you in due course when we have more visibility.
Speaker #4: And we'll provide you all the information required at that time.
Speaker #1: And then, on your third question on Billway—regarding the second quarter—actually, the underlying demand is going very well. We have seen a pickup in Q1, and in Q2 we continued to see a pickup in the underlying demand.
Speaker #1: There was a small inventory effect in Q1, which explains why you have seen the second quarter not growing so strongly. But we anticipate good growth on Billway.
Speaker #1: Perhaps Christelle, on the biliary treasure trial regarding subgroups?
Speaker #3: Yes, absolutely. So we only read out the top-line data last week. So we are continuing to analyze the full data set, and we'll come back later on on this point.
Speaker #1: Thank you.
Speaker #3: Thank you for your help. Thank you.
Speaker #1: Thank you. Next question, please.
Speaker #2: Thank you. We will now take our next question. From the line of Victor Flog from BNP Paribas, please go ahead.
Speaker #5: Hi. Thanks so much for taking my question, and congrats for the study prints. Recent pipeline and M&A development. So maybe first question on Dysport and the migraine opportunity.
Speaker #5: I was wondering whether you can discuss your ambition across both subsets of the migraine market, and specifically, should we assume that the migraine launch will push Dysport Therapeutics’ growth toward the 8% upper bound of your 2023 CMV guidance?
Speaker #5: Any chance you could discuss also the extra investment needed to be competitive in the chronic market, and to unlock the episodic market? And finally, you know, once again, around margin, any chance you can discuss 2027 margin, obviously, you've mentioned you want to invest into Dysport.
Speaker #5: You've mentioned some dilution coming from the recent M&A you've done. And there is also, like, some uncertainty around Zymetalin. So I mean, I was just wondering whether you were, like, comfortable with the 34% EBIT that was currently motivated by consensus and whether you can add anything to help us, like, model guidance margin next year.
Speaker #5: Thank you very much.
Speaker #1: Yeah. Thanks, Victor. On Dysport migraine, our ambition is being I would say calculated right now, because we have seen very strong results. And you're going to see them at an upcoming conference.
Speaker #1: And this is the first in class, really, having an episodic significant result. So clearly, that can help expand the market quite significantly, because there are many more episodic migraine sufferers than chronic.
Speaker #1: And you have heard Mary elaborate on this. So we are analyzing this, and we will come back with more precise guidance. But clearly, we want to penetrate both segments.
Speaker #1: Regarding, you know, the above 8% or higher high-single-digit we will provide you potentially by next year a bit more flavor to this, because we want to do more market research.
Speaker #1: And then once people have seen the data, that's going to help us really get the reactions. And come back on a more precise figure.
Speaker #1: Obviously, the investment in migraine is pretty significant. We have seen you know, for example, several companies migraine companies do DTC. So we also plan to do that.
Speaker #1: And we're going to also significantly expand, obviously, our field force. To be competitive here, because this is a very big opportunity for us. And we were very pleased to see that we also have the episodic trial, which is positive.
Speaker #1: So that's great news, I would say, for us. Which truly differentiates the molecule. On the margin 2027, I have Aymeric. Answer that?
Speaker #4: Yeah. So thank you for the question. I mean, as you know, in July we did provide guidance for 2027. We were talking about the outlook.
Speaker #4: We are really comfortable. I think that, to provide you with a little bit of detail and help you a bit versus the consensus, I think the consensus today is not factoring in, first, the very strong momentum that we have today and the significant upgrade to our guidance for 2026.
Speaker #4: I think it's not fully factoring in the impact of the recent acquisition. So, what we see for 2027 is, first, that even if generics should enter the market for Zymetalin—and as you've said before, we expect that by the end of this year—
Speaker #4: So this will have an impact in 2027. The strength of the rest of the portfolio means that we will continue to grow in 2027.
Speaker #4: But margin will be impacted, and I think you mentioned the big driver of that. Clearly, there will be a significant impact from the recent acquisition, mainly Memo, where we have to not only prepare for the launch, but also still carry the phase three that Mary and Christelle presented.
Speaker #4: But also Memo, and on top of that, as David just described, we're going to prepare and be ready for the launch of Dysport in migraine.
Speaker #4: This will have a significant impact on the profitability. That's what you should expect in 2027.
Speaker #5: Thank you very much.
Speaker #1: Thank you. Next question.
Speaker #2: Our next question comes from the line of Simon Baker from Rothschild & Co. Redburn. Please go ahead.
Speaker #5: Thank you. Thank you very much for taking my two questions. Please firstly, going to Nav to Madeleine. The opportunity in myelofibrosis on its own looks like a really interesting one, for you.
Speaker #5: But MDM2 inhibition goes a long way beyond myelofibrosis, into areas like glioblastoma, which feels like a sort of an Ipsen-friendly indication. So I just wondered what your thoughts were on the broader potential of that asset beyond myelofibrosis?
Speaker #5: And then a general question. You did allude to the remaining firepower. So I just go back to the question we all ask regularly, which is just an update on the business development landscape as you see it.
Speaker #5: Q2, in terms of deal volume, was the largest quarter this decade. So I just wanted to see what trends you were seeing in the areas of BD that you're looking at.
Speaker #5: Thanks so much.
Speaker #4: Thank you, Simon. I will ask
Speaker #1: Christelle to answer on Nav to Madeleine.
Speaker #3: Thank you for that question. So, to the fact that MDM2 might have myelofibrosis, you will remember that a number of MDM2 compounds have been studied in many different indications and may not have given very hopeful results.
Speaker #3: With Nav to Madeleine, we have a solid compound in our hands, and we are focusing on its development in myelofibrosis. We will take the time to further assess the potential of that specific molecule for other indications.
Speaker #3: But it's too early to say.
Speaker #1: And perhaps just to add to this, CARTA spent an enormous amount of time to go back to the research bench and actually look what is the optimal cycling of MDM2s.
Speaker #1: And so that's why we believe they have done a really nice piece of work. And that's why they have seen the efficacy. They have seen in myelofibrosis.
Speaker #1: So we're encouraged by that. And of course, now the question is going to be: OK, what would be the cycling in other indications? So there needs to be more work done there.
Speaker #1: On the firepower, and the BD landscape. I mean, first of all, we're not driven by what others do. We analyze, you know, the companies and the opportunities that we like.
Speaker #1: So we will do the deals when we think we see something which is very interesting. So the two deals that we have just done, we felt were very compelling.
Speaker #1: We have the firepower to do more. So we will continue to try to do deals across the spectrum, be it late stage or also earlier stage in oncology, hematology, and rare.
Speaker #1: In neuroscience, as you have heard us talk about, CARBOTASE, we actually think that's a pipeline in the product. This product has an enormous potential.
Speaker #1: We are developing it as we speak also in the therapeutics in three indications. And if those work, we might actually also go broader than that.
Speaker #1: So that's why we're focusing our BD activities mostly currently on oncology, hematology, and rare disease.
Speaker #5: Great. Thanks so much.
Speaker #1: Thank you. Next question, please.
Speaker #2: Thank you. Our next question comes from the line of Raghuram Selvaraju from HSA Werenwhite. Please go ahead.
Speaker #5: Hi. Thank you for taking our question. This is Ahmed Anfuram, and congrats on the strong quarter. So I just had a question two questions, actually, one on IPN60340.
Speaker #5: So the non-responders in eviction had lower baseline gamma delta T cells, and a weaker IFN induction. So I was wondering if this is something that you will be stratifying for, or are you going to pre-specify the subgroup variable in eviction three?
Speaker #5: And what kind of evidence would lead you to pursue biomarker enrichment and broad all-comer development? And then I'll ask my second question.
Speaker #3: OK. So which means that's a question for me. So the eviction data from the phase one were very strong and gave us a really good confidence of the potential of IPN6340 or ICTO1 as others may have.
Speaker #3: In memory. However, it was a single-arm study. Therefore, our design is a phase two B3 study that allows us to further understand in the phase two exactly what you referred to, and to compare to Veneza as a comparative arm.
Speaker #3: So on the basis of the phase two, we'll have a richer data set that will allow us to have the strong phase three design.
Speaker #3: So we are addressing that, generating more biomarker-based data in our phase two. Thank you.
Speaker #4: Thank you. And then just a quick question on Belvey. So following the Bolt setback, I guess, where do you see the most compelling opportunity to stick spend?
Speaker #4: And are you prioritizing these indications based on biological rationale development feasibility, or commercial potential?
Speaker #1: Yeah. I think Mary can answer this one.
Speaker #6: So on Belvey, of course, we're disappointed with biliary trees in Bolt, but we're very focused on the growth potential we do have, and are seeing in PFIC and allogene as a reminder.
Speaker #6: We have a very broad use in both the pediatric population and the adult population. We're continuing to see a good amount of growth in both incident and prevalent population.
Speaker #6: And especially the adult population of growth for both PFIC and allogene has been considerable, both in the US and across other markets as well.
Speaker #6: As a reminder, we're continuing to get pricing and reimbursement and additional geographies with Belvey. So what you see today in terms of US, Europe, and rest of the world, we expect continued growth for PFIC and allogene with the biliary with Belvey in the coming quarters and years.
Speaker #6: In terms of exploring other areas of opportunity, as you know, we have a very strong evidence base we continue to work with investigators and HCPs across the world with quite a few investigator-initiated trials.
Speaker #6: And we'll continue to explore additional opportunities for further advice about in Belvey, as we reflect on the studies with the VA.
Speaker #4: Got it. Thank you.
Speaker #1: Thank you. Next question.
Speaker #2: Thank you. Our next question. Comes from the line of Nusrat Hussain from UBS. Please go ahead.
Speaker #7: Hi. This is Nusrat on behalf of Shan. Thanks for taking my questions. Do please. Firstly, on the guidance upgrade, could you quantify how much of this reflects the delayed some actual in generic entry versus the rest of the portfolio?
Speaker #7: And secondly, how do you expect the recent DARA data to affect Onovite? And when do you anticipate DARA entering the market? Thank you.
Speaker #1: Thank you, Nusrat. First, on the guidance, Aymeric.
Speaker #4: Yeah. So I think on the guidance, it's very similar to what you see on the first performance. So the first performance was really driven on one side by the strong performance of somatoline.
Speaker #4: On the other side, by the rest of the portfolio. And I think that the upgrade that you see today is really coming from both.
Speaker #4: As we said, some delay on the entry of generics now is more Q4, where it was more Q3 in the second half of the year, but also a better pricing environment.
Speaker #4: And on the other side, I think the rest of the portfolio doing very, very, very well. We talk about Icurvo. We talk about Belvey.
Speaker #4: We talk about D Sports and also Agenda driving really that upgraded guidance for 2026.
Speaker #1: And then on your second question on DARA, we expect DARA to enter fairly soon, probably by September. And from what we understand, they're going to get a second line label.
Speaker #1: So that's going to have, of course, somewhat of an impact on Onivite in that setting. We also expect DARA, given the results, eventually to go into first line.
Speaker #1: We hear a lot of feedback from KOLs that they think it might actually expand the pool of treated patients. So while short term, we might take a bit of a dip, we will have to see longer term what this does to the Onivite sales.
Speaker #1: And Onivite is probably going to be pushed a bit to later lines initially. But then we will have to observe if indeed that effect that KOLs have been stating that more patients might be treated and be more fit, actually, if that has a beneficial effect eventually mid to longer term.
Speaker #1: So it remains to be seen. Thank you.
Speaker #7: Thank you.
Speaker #1: Next question, please.
Speaker #2: Thank you. Our next question. Comes from the line of Benjamin Jackson from Jefferies. Please go ahead.
Speaker #4: Great. Thank you for the question, guys. Just a couple from me. The first just a quick clarification when you're talking about 2027 growth. Can I just clarify whether you mean on like on an absolute basis when all is said and done, post the transactions and the incremental spending, or are you talking more about the underlying possibility of the business growing for like for like?
Speaker #4: Secondly then, interested to know your thoughts on to what extent episodic migraine patients might currently be prescribed toxins off label. Is there perhaps a risk that that market is already being established, or perhaps even a benefit that that is already being established by the incumbent?
Speaker #4: And then finally, just interested to know what you're thinking about making the timing of making a decision on the highest value path forward for Coerabites in aesthetics.
Speaker #4: Do you think you need to see the therapeutics data first? And how could those results ultimately impact that decision? Thank you so much.
Speaker #1: Thank you, Ben. On the 2027, I'll let Aymeric answer.
Speaker #4: So I'm not sure I fully captured the question, but maybe to provide you a little bit more of view on 2027. I mean, in terms of top line, we still anticipate to be able to grow in 2027.
Speaker #4: It's clearly not going to be the same as 2026, where we see the big upside from somatoline. But despite the impact that entry of generic could have in 2027 and potentially additional one that could enter during next year, we still expect that the strength of our portfolio, excluding somatoline, will allow us to continue to grow.
Speaker #4: And that will support, clearly, a strong level of margin. But that level of margin will be clearly impacted by the additional R&D expenses associated with the acquisition, especially the Cartos acquisition, and also all the commercial investment that will be significant to really set up the best commercial organization to be successful for the Cartos product, NAV, but also for the migraine opportunity.
Speaker #1: On your second question on episodic migraine, as you light out, there was in the past some spontaneous uptake on Botox in episodic, but you remember that they had a failed study in episodic.
Speaker #1: So we would anticipate now that we have demonstrated with D Sports that it works very clearly in episodic migraine. And that we will be able to fully promote it, that this is going to very significantly expand the market opportunity in migraine so I think the spontaneous use, if there is now, is probably relatively minor versus what can be done once we have a label and once we can fully promote it.
Speaker #1: On Coerabites, AXTX, so as we said, we're waiting for more data. So we have the FHL LCL data coming. And then also the triple combination in aesthetic together with Glabelline in the stage three of that phase two trial.
Speaker #1: And we're also waiting for the proof of concept trial readout. In migraine cervical dystonia and in specificity. I mean, it's very important, of course, to first understand the readouts of these studies and also what might be the dose that will be required in the different indication because it obviously has potential an impact on pricing.
Speaker #1: And so this is something that we want to see the data first before we take any decisions. Thank you. Next question.
Speaker #2: Thank you. We will now take our final question. From the line of Raghuram Selvaraju from HC Wenwright, please go ahead.
Speaker #4: I think so much for taking my questions again. I just had one on Poiesis and how kind of so I know you plan to randomize 180 out of 600 incomers.
Speaker #4: After the RUCs run in, I was just wondering if you could give some color on whether that conversion is tracking to plan. Should we expect attrition to RUCs response, and are you using this as a proxy to inform the commercially addressable population?
Speaker #1: So perhaps first, Chris Dell on the scientific piece, and then Mary on the commercial piece.
Speaker #3: So maybe to give a little more color to today, myelofibrosis patients, those who are TP53 wild type, intermediate high risk, they receive ruxolitinib as their cornerstone treatment.
Speaker #3: RUC so is often very effective in those patients. And maintaining and controlling symptoms and spleen volume reduction. However, in that population over time, the response wanes and within the 18 to 24 months, a majority of patients becomes subresponsive.
Speaker #3: And that has been shown in measured by the spleen volume and also the total symptom score. So that is how we structured actually our entry to phase three as you have described is there's a running period and then those patients who are suboptimally controlled receive naftamidine as an add-on.
Speaker #3: I'm now going to hand up to Mary to give you what is the impact?
Speaker #5: So to answer your question also further in terms of the current study, phase three, as you mentioned, there's 600 patients enrolled. As we understand Cartos is tracking very well to the predicted suboptimal response.
Speaker #5: As you might be familiar, that suboptimal response evolves over time. And so when we track it at that 18 weeks and further, it's evolving exactly to the curves that have been published before so it's behaving as would be expected.
Speaker #5: Now, that's exactly how we see it from a commercial and future opportunity perspective as well. It's really important to anticipate that that suboptimal response does evolve over time, as Chriselle mentioned.
Speaker #5: And we are preparing and will work post-close with the Cartos team and as we integrate into IPSEN, how we will prepare both the medical education as you anticipate this might be a very significant change also to the treatment paradigm.
Speaker #5: What we think is really novel is the opportunity to combine with RUCs, which are such a mainstay of treatment. And we hope that with NAV, the Madeleine in combination with RUCs, these patients are going to experience that sustained response over time and really improve the care for myelofibrosis patients.
Speaker #5: So we're really optimistic and we're very encouraged by the data that we see in terms of the trial operations.
Speaker #4: Thank you.
Speaker #1: Thank you, Raghuram. Operator, I understand we have another question.
Speaker #2: Correct. We will now take our next question from the line of Victor Flog from BMP Paribas.
Speaker #4: Yeah, thanks for taking my follow-up. Very quick one on Coerabitas, and so you've mentioned the phase two update this year. So maybe can you just remind us what's about this stage two?
Speaker #4: What should we expect in terms of data that are going to be reported before end of the year? And how meaningful is it or incrementally it would be to better to get a better sense of the potential of Coerabitas in access indications?
Speaker #4: Thank you very much.
Speaker #1: Yeah. So the data before the end of the year is in aesthetics in FHL and LCL. But as I said, we will also do then the stage three of that phase two trial, which is going to combine Glabelline, FHL, and LCL.
Speaker #1: And so we are looking forward to the readouts of this first Stage 2, and then continuing on to Stage 3. So I think that was our last question, operator.
Speaker #2: Yes, no more questions at this time.
Speaker #1: Thank you very much, everybody.
