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. Please turn to slide 2.

Before we begin, please take note of the forward-looking statement and risk factors described on this slide. Unless otherwise stated, growth comments during the presentation are at constant exchange rates.

Please turn to slide 3. I will start with the business update, Aymeric will then cover the financial update, Christelle will take you through the R&D progress, and Mari will cover the commercial update.

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, 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.

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.

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.

Aymeric will provide more details in his section. Slide 6.

Turning to sales performance, total sales reached €2.2 billion in the first half, growing 23.5% at constant exchange rates. All three therapeutic areas contributed positively.

Oncology grew 15.6%, Rare Disease grew 108%, and Neuroscience grew 16.6%. Importantly, total sales, excluding Somatuline, grew 24.8%, demonstrating the breadth of growth across the business.

Please turn to slide 7. Starting with Oncology, H1 sales grew 15.6% to €1.45 billion.

Somatuline delivered €686 million, supported by performance in the US and Europe, ongoing generic lanreotide supply constraints, and growth in rest of world. Cabometyx 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. Iqirvo reached €173 million, driven by higher patient numbers in the US and strong launches across European countries.

Bylvay reached €120 million, reflecting strong growth in PFIC and Alagille in the US and Europe with increasing contribution from rest of world. 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 world countries. Therapeutics reached €170 million, up 13.8%, with double-digit growth in the US and Europe, partially offset by tender phasing in rest of the world.

Please turn to slide 8. I wanted to highlight the evolution of our late-stage pipeline.

We have now delivered three positive Phase III readouts: two for Dysport in therapeutics across episodic and chronic migraine, both showing very strong results, and one for Iqirvo in PBC through the ELSPAR studies, both assets, Iqirvo in PBC and Dysport in therapeutics, with blockbuster potential. At the same time, we are advancing three important late-stage assets: corobotase in glabellar lines, elafibranor in PSC, and IPN60340 in AML, reinforcing the depth and breadth of our internal pipeline.

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. 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. With Kartos Therapeutics, we are adding navtemadlin, a Phase III oral MDM2 inhibitor for myelofibrosis, strengthening our hemato-oncology pipeline.

With Memo Therapeutics, we are adding potrevimab, a first-in-class anti-BK polyomavirus antibody for post-transplant nephropathy, strengthening our rare disease pipeline. 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. Please turn to slide 10.

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.

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.

Total sales reached €2.2 billion, growing 23.5% at constant exchange rates. Core operating income increased even further by 28.8% to €845 million, while free cash flow was also very strong at €652 million, up 34.9% year-over-year.

Consequently, after the announced Kartos and Memo acquisition, we will still have more than €2 billion of pro forma firepower for external innovation based on net debt including contingent liabilities and commitments at two times EBITDA. Let's go into the details of this financial 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 rates, including an adverse impact of currency for 3.1 points.

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 goods of sales due to favorable product mix.

SG&A 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. 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 corobotase and early-stage oncology assets.

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.

Cash flow generation was also very strong in the first half. Free cash flow increased by almost 35% to €652 million, driven by higher EBITDA, up 27%, and a disciplined management of capital expenditures and working capital.

Net cash reached €1 billion, an improvement of €445 million versus December 2025, after limited investment, only €40 million related to regulatory commercial milestone, and the proceeds from the sale of equity investment shares, and after payment of dividend for €132 million. Based on that level of net cash at the end of June, and as I said, on a pro forma basis, after the announced acquisition of Kartos and Memo, we will have more than €2 billion of remaining firepower for external innovation.

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.

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 is assuming a stronger growth for Somatuline, with an entry of lanreotide generics later in the second half.

We also expect higher growth across the rest of the portfolio, notably driven by Bylvay, Iqirvo, and Dysport, but also an higher contribution from our new product, Ojemda. We are also upgrading our core operating margin guidance by two 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 Kartos Therapeutics.

This improvement is driven mainly by the higher level of sales, but factors also on top of additional R&D expenses, pre-launch preparation expenses for Dysport in migraine. With all of that, I will now hand over to Christelle for the R&D update.

Please turn to slide 15.

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. In Oncology, momentum is building across late-stage and early-stage assets: Ojemda continues in first-line pediatric low-grade glioma with FIREFLY-2, the Eviction-3 study is open for IPN60340, and three Phase I programs are advancing well.

In Rare Diseases, we made important progress with the positive ELSPAR Phase IIIb data for Iqirvo in a PBC population that remains symptomatic on standard of care. We also opened ELEVATE, the first global Phase III 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. In Neuroscience, Dysport delivered positive Phase III data in both chronic and episodic migraine, while corobotase continues to expand and accelerate with the Phase III Low-Light open in glabellar lines, and a broader six-indication program advancing across aesthetic and therapeutic indications.

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. The two Phase III trials, SEE-BEYOND and E-BEYOND, 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 III results in both episodic and chronic migraine. The episodic results is particularly meaningful, as it is the first Phase III trial of a botulinum toxin to show a statistically significant reduction in monthly migraine days in this larger patient population with significant unmet need.

Dysport was well tolerated, with safety consistent with its known profile. In a condition that affects nearly 1 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.

Please turn to slide 18. Our third positive Phase III readout this month was the Phase IIIb ELSPAR trial evaluating Iqirvo 80 mg versus placebo in patients with PBC where ALP levels were between 1 and 1.67 times the upper limit of normal on or after UDCA treatment.

The results were impressive, with 85% of patients treated with Iqirvo achieving ALP normalization compared with 23% on placebo, with a very significant p-value below 0.0001. This is meaningful because ALP normalization is increasingly recognized as an important treatment goal in PBC and is associated with improved long-term prognosis and slower disease progression.

ELSPAR reinforces Iqirvo's clinical profile and supports the opportunity to treat a broader group of eligible second-line PBC patients. The data will be presented later this year at a scientific congress during the second half.

Please turn to slide 19. Looking ahead, in Neuroscience, later this year, we expect proof-of-concept data from the stage 2 of our Atlantic trial for corobotase in two further aesthetics indications: forehead lines and lateral canthal lines.

In 2027, we expect therapeutics proof-of-concept data in two indications, followed by the first aesthetics Phase III readout in 2028. In Oncology, we expect topline data for Ojemda in first-line pediatric low-grade glioma in 2027.

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 Kartos Therapeutics, navtemadlin is an oral MDM2 inhibitor in development for myelofibrosis. The global Phase III POIESIS trial is ongoing, evaluating navtemadlin as an add-on therapy to ruxolitinib with more than 600 patients across 250 sites, and we expect topline data in 2027.

The goal here is to improve spleen and symptom responses in suboptimal responders to achieve a clinically meaningful response. The Phase Ib/II data with navtemadlin showed improvement in spleen volume and total symptom score, together with reductions in driver-variant allele frequency and bone marrow fibrosis, supportive of a potential disease modification.

Now turning to Memo, potrevimab 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 an associated nephropathy that damages the new kidney.

Potrevimab 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. The totality of evidence from the Phase II Safe-Kidney-2 trial supports the initiation of a pivotal Phase II/III trial later this year.

I will now hand over to Mari to cover the commercial update. Please turn to slide 21.

Thank you, Christelle. I will now cover the commercial update, focusing on the growth opportunities created by our advancing pipeline and the recent portfolio progress.

Please turn to slide 22. Let me begin with Dysport in migraine.

As you will have seen, we recently reported positive beyond Phase III results in both the chronic migraine SEE-BEYOND trial and the episodic migraine E-BEYOND trial. 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. We expect Dysport to gain share in this growing segment.

Then the E-BEYOND results also support the potential use of Dysport in episodic migraine. This would considerably broaden the patient population that may benefit.

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. Pending regulatory approvals, we expect to launch Dysport in the migraine indications in the second half of 2027.

Taken together across indications, we see Dysport as a compelling overall strategic opportunity for Ipsen. Please turn to slide 23.

Next, I will discuss Iqirvo and our recent positive Phase III ELSPAR data in PBC. As a reminder, ELSPAR was designed to complement our original Phase III ELATIVE study by evaluating patients with ALP levels between 1 and 1.67 times upper limit of normal.

Taken together, ELATIVE and ELSPAR now provide clinical evidence for Iqirvo across a broad spectrum of second-line PBC patients. A key point to note is that the current US and EU regulatory approvals for Iqirvo are broad and do not specify an ALP threshold, meaning patients with ALP levels between 1 and 1.67, or the ELSPAR population, are already included within the approved indications.

As to the patient population, over the past couple years, while we've had good uptake and penetration of the PPARs for PBC patients, strong opportunity still remains. 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 ELSPAR population.

We continue to focus on the importance of striving for deeper biochemical responses and ALP normalization as a treatment goal. Our emphasis is now on translating the full Iqirvo dataset into clinical practice through continued physician and patient education and supporting appropriate treatment across all eligible second-line PBC patients.

Commercially, we upgrade our peak sales estimate for Iqirvo to €1 billion in PBC based on our confidence in the continued growth and a broader adoption of Iqirvo across eligible PBC patients. Please turn to slide 24.

Moving next to external innovation, I will first start with Kartos and navtemadlin. As announced a few weeks ago, we entered into an agreement with Kartos for navtemadlin, an investigational oral MDM2 inhibitor for myelofibrosis.

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.

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, ruxolitinib has become the standard of care for these MF patients.

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, who only partially benefit, and persistent disease burden, highlighting the need for treatment options that can deepen and extend response.

This is where navtemadlin has the potential to play an important role. The ongoing Phase III POIESIS study is evaluating navtemadlin 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. These are endpoints that are well established as clinically 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 III results and regulatory approvals, see potential for launch as early as 2028. In summary, navtemadlin adds late-stage hematology-oncology asset to our pipeline with the potential to address a significant unmet need and further strengthens our Ipsen growth outlook.

Please turn to slide 25. Looking next to Memo Therapeutics and potrevimab.

With this acquisition, which we completed just last week, we are adding potrevimab, a Phase II/III-ready monoclonal antibody targeting BK polyomavirus, further extending our rare disease pipeline beyond liver diseases. We see an exciting opportunity here to make a major advance for kidney-transplant patients.

Approximately one-quarter of kidney-transplant recipients develop BK viremia. If left uncontrolled, this can lead to BK-VAN, which can then induce graft damage, loss of kidney function, and ultimately, for some, graft failure.

Today, unfortunately, there are no approved therapies specifically targeting BK virus. 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 then 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. 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.

Hence, we are looking forward to further progressing with potrevimab in this important area. Stepping back, the recent positive Phase III data for Dysport in chronic and episodic migraine, the positive Phase III ELSPAR results for Iqirvo in PBC, and with the addition of navtemadlin and potrevimab, we have further strengthened both the near and the longer-term outlook of our portfolio.

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.

Please turn to slide 26.

Thank you, Mari. 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. 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 the future growth.

At the same time, the pipeline has advanced materially. We now have three positive Phase III readouts across Dysport in migraine and Iqirvo in PBC, alongside a broader late-stage pipeline with both internal and externally sourced assets.

Commercially, the opportunity set is expanding. Iqirvo, navtemadlin, and potrevimab each have significant potential, while we continue to evaluate the full potential of Dysport in migraine following positive Phase III data.

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. Please turn to slide 28.

Thank you. We will now open the call for questions.

this is Yihan from Barclays. Congrats on the quarter, and thanks for taking our questions.

I have two, please. The first one is on Somatuline.

I'm not sure if I heard it correctly, but earlier on the call, you said you expect stronger growth for Somatuline with an entry of generics in the second half. Based on the Amneal's second quarter earnings slides today, they still guided for a third quarter launch.

Just wanted to better understand, what is your rationale behind this stronger growth, and could you please help us to understand, the Somatuline generic competitive assumptions that embedded in your second-half outlook? Also separately, with the existing mid-term targets increasingly outdated, when should we expect an update, maybe a CMD likely next year?

My second question is on Bylvay. The second quarter sales were slightly below the expectation.

Just curious, could you please discuss the underlying demand trends, and also your expectations for the growth from here, and also the recent Phase III BOLD, BA trial failure? Just curious, did you observe any, positive signals in subgroups that could potentially support further analysis?

Thank you so much.

Thank you, Yihan Li. On Somatuline, we do in our guidance indeed assume the Amneal launch, so that's included.

The reason why we think that Somatuline, 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, and that translates into a higher ASP in the US, which over time gives a positive benefit in the second half. That explains that comment.

On the midterm, I'll let Aymeric answer. Yes,

I think on the mid-term guidance, your question was, do we plan a Capital Market Day? I think as you said, we are highly confident that the mid-term outlook to 2027, we are fully on track to highly and exceed.

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, and we'll provide you all the information required at that time.

Then

on your third question on Bylvay, the second quarter, actually the underlying demand is going very well. We have seen a pickup in Q1 and in Q2, continued pickup on the underlying demand.

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 Bylvay. Perhaps Christelle on the biliary atresia trial regarding subgroups?

Yes, absolutely. We only read out the topline data last week, we are continuing to analyze the full dataset and will come back later on on this point.

Thank you.

That's super helpful. Thank you.

Thank you. Next question, please.

Hi, thanks so much for taking my question, and congrats for this very prints, recent pipeline, and M&A development. Maybe first question on Dysport and the migraine opportunity, 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 put these therapeutic growth toward the 8% upper bound of your 2023 CMD guidance?

Any sense you could discuss also the extra investment needed to be competitive in the chronic market and to unlock the episodic market? Finally, once again around margin, any chance you can discuss 2027 margin elasticity?

You mentioned you want to invest into Dysport, you've mentioned some dilution coming from the recent M&A you've done, and there are also some uncertainty around Somatuline. I was just wondering whether you were comfortable with the 34% EBIT that was currently modeled by consensus, and whether you can add anything to help us model guidance margin next year.

Thank you very much.

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.

This is the first-in-class really having an episodic significant result. Clearly, that can help expand the market quite significantly because there are many more episodic migraine sufferers than chronic, and you have heard Mari elaborate on this.

We are analyzing this, and we will come back with more precise guidance. Clearly, we want to penetrate both segments.

Regarding, 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, 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. Obviously, the investment in migraine is pretty significant.

We have seen, for example, several companies, migraine companies do DTC, we also plan to do that, 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. We were very pleased to see that we also have the episodic trial which is positive, so that's great news, I would say, for us, which truly differentiates the molecule.

On the margin 2027, I have Aymeric answer that.

Thank you for the question. As in July, we're not providing a guidance for 2027.

We were talking about the outlook where we are really comfortable. I think that to provide you maybe a little bit of detail and help you a little bit versus the consensus, I think the consensus today is not factoring first the very strong momentum that we have today and the significant upgrade to our guidance for 2026.

I think it's not fully factoring also the impact of the recent acquisition. What we see for 2027 is first that even if generic should enter the market of Somatuline, and as you've said before, we expect that by the end of this year, this will have an impact in 2027, the strength of the rest of the portfolio means that we will continue to grow in 2027.

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 III that Mari and Christelle presented, 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.

This will have a significant impact on the profitability. That's what you should expect in 2027.

Thank you very much.

Thank you. Next question.

Thank you. Thank you very much for taking my two questions, please.

Firstly, going to navtemadlin, the opportunity in myelofibrosis on its own looks like a really interesting one for you. MDM2 inhibition goes a long way beyond myelofibrosis, into areas like glioblastoma, which feels like a sort of an Ipsen-friendly indication.

I just wondered, what your thoughts were on the broader potential of that asset beyond myelofibrosis. Then a general question, you did allude to the remaining firepower.

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. There's Q2 was the, in terms of deal volume, was the largest quarter this decade.

Just wanted to see what trends you were seeing in the areas of BD that you're looking at. Thanks so much.

Thank you, Simon. I will ask Christelle to answer on navtemadlin.

Thank you for that question. To the fact that MDM2 might have a bigger potential beyond 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.

With navtemadlin, we have a solid compound in our hands, and we are focusing on its development in myelofibrosis, and we will take the time to further assess the potential of that specific molecule for other indications, but it's too early to say.

Perhaps just to add to this, Kartos spent an enormous amount of time to go back to the research bench and actually look what is the optimal cycling of MDM2s, 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. We're encouraged by that, and of course now the question is going to be, okay, what would be the cycling in other indications?

There needs to be more work done there. On the firepower and the BD landscape, first of all, we're not driven by what other do.

We analyze the companies and opportunities that we like. We will do the deals when we think we see something which is very interesting.

The two deals that we have just done we felt were very compelling. We have the firepower to do more.

We will continue to try to do deals across the spectrum, be it late-stage or also earlier-stage in oncology, hematology, and rare. In neuroscience, as you have heard us talk about corobotase, we actually think that's a pipeline in a product.

This product has an enormous potential. 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.

That's why we are focusing our BD activities mostly currently on oncology, hematology, and rare disease.

Great. Thanks so much.

Thank you. Next question, please.

Hi, thank you for taking our question. This is Ahmed on for Ram, and congrats on the strong quarter.

I just had a question, two questions actually, one on IPN60340. The non-responders in Eviction had lower baseline gamma delta T cells and a weaker IFN induction.

I was wondering if this is something that you will be stratifying for, you're going to pre-specify as subgroup variable in Eviction-3. What kind of evidence would lead you to pursue biomarker enrichment and broad all-comer development?

Then I'll ask my second question.

Which means that's a question for me. The Eviction data from the Phase Ib was very strong and gave us a really good confidence of the potential of IPN60340, or ICT01 as others may have in memory.

However, it was a single-arm study. Therefore, our design is a Phase IIb/III study that allows us to further understand in the Phase II exactly what you referred to and to compare to ven/aza as a comparative arm.

On the basis of the Phase II, we'll have a richer dataset that will allow us to have a strong Phase III design, we are addressing that, generating more biomarker-based data in our Phase II. Thank you.

Thank you. Then just a quick question on Bylvay.

Following the BOLD setback, I guess, where do you see the most compelling opportunity to expand? Are you prioritizing these indications based on biological rationale, development feasibility, or commercial potential?

I think Mari can answer this one.

On Bylvay, of course we're disappointed with biliary atresia in BOLD, but we're very focused on the growth potential we do have and are seeing in PFIC and Alagille. As a reminder, 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, and especially the adult population of growth for both PFIC and Alagille has been considerable, both in the US and across other markets as well. As a reminder, we're continuing to get pricing and reimbursement in additional geographies with Bylvay.

What you see today in terms of US, Europe, and rest of the world, we expect continued growth for PFIC and Alagille with the Bylvay in the coming quarters and years. In terms of exploring other areas of opportunity, as 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, and we'll continue to explore additional opportunities for odevixibat and Bylvay as we reflect on the studies with BA.

Got it. Thank you.

Thank you. Next question.

Hi, this is Nusrath on behalf of Xian. Thanks for taking my questions.

Two, please. Firstly, on the guidance upgrade, could you quantify how much of this reflects the delayed Somatuline generic entry versus the rest of the portfolio?

Secondly, how do you expect the recent Dara data to affect Onivyde? When do you anticipate Dara entering the market?

Thank you.

Thank you, Nusrath. First on the guidance, Aymeric.

I think on the guidance, it's very similar to what you see on the first-half performance. The first-half performance was really driven on one side by the strong performance of Somatuline, on the other side by the rest of the portfolio.

I think that the upgrade that you see today is really coming from both. As we said, some delay on the entry of generic, now it's more Q4 where it was more Q3 in the second half of the year, but also a better pricing environment.

On the other side, I think the rest of the portfolio doing very, very, very well. We talk about Iqirvo, we talk about Bylvay, we talk about Dysport, and also Onivyde driving really that upgraded guidance for 2026.

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. That's going to have, of course, somewhat of an impact on Onivyde in that setting.

We also expect Dara, given the results, eventually to go into first line. We hear a lot of feedback from KOLs that they think it might actually expand the pool of treated patients.

While short term, we might take a bit of a dip, we will have to see longer term what this does to the Onivyde sales. Onivyde 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.

Remains to be seen. Thank you.

Next question, please.

Great. Thanks 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 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 for-like-like? 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 has already been established or perhaps even a benefit that that is already being established by the incumbent?

Then finally, just interested to know what you're thinking about making a or the timing of making a decision on the highest value path forward for corobotase in aesthetics. Do you think you need to see the therapeutics data first, and how could those results ultimately impact that decision?

Thank you so much.

Thank you, Ben. On the 2027, I'll let Aymeric answer.

I'm not sure I fully captured the question, but maybe to provide you a little bit more of view on 2027, in terms of topline, we still anticipate to be able to grow in 2027. It's clearly not going to be the same as 2026, where we see the big upside from Somatuline.

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 Somatuline, will allow us to continue to grow. That will support clearly a strong level of margin, but the level of margin will be clearly impacted by the additional R&D expenses associated with the acquisition, especially the Kartos acquisition, and also all the commercial investment that will be significant to really set up the best commercial organization to be successful for the Kartos product, nav, but also for the migraine opportunity.

On your second question on episodic migraine, as you lined out, there was in the past some spontaneous uptake on Botox in episodic, but you remember that they had a failed study in episodic. We would anticipate now that we have demonstrated with Dysport 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.

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. On corobotase, AXTX, so as we said, we're waiting for more data, we have the FHL, LCL data coming, and then also the triple combination in aesthetic together with glabellar line in the stage 3 of that Phase II trial.

We're also waiting for the proof-of-concept trial readouts in migraine, cervical dystonia, and in spasticity. It's very important, of course, to first understand the readout of these studies, and also what might be the dose that will be required in the different indications because it obviously has potentially an impact on pricing.

This is something that we want to see the data first before we take any decisions. Thank you.

Next question.

Thanks so much for taking my questions again. I just had one on POIESIS, and how, I know you planned to randomize 180 out of 600 incomers after the Rux run-in.

I was just wondering if you could give some color if the conversion is tracking to plan. Should we expect attrition to Rux response?

Are you using this as a proxy to infer inform the commercially addressable population?

Perhaps first Christelle on the scientific piece, and then Mari on the commercial piece.

Maybe to give a little more color to this, today myelofibrosis patients, those are who are TP53 wild-type, intermediate high risk, they receive ruxolitinib as their cornerstone treatment. Ruxo is often very effective in those patients at 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 become subresponsive, and that has been shown and measured by the spleen volume and also the total symptom score. That is how we structured actually our entry to Phase III, as you have described, is there's a run-in period, and then those patients who are suboptimally controlled receive navtemadlin as an add-on.

I'm now going to hand up to Mari to give you what is the impact.

To answer your question also further in terms of the current study, Phase III, as you mentioned, there's 600 patients enrolled. As we understand, Kartos is tracking very well to the predicted suboptimal response.

As you might be familiar, that suboptimal response evolves over time. When we track it at that 18 weeks and further, it's evolving exactly to the curves that have been published before.

It's behaving as would be expected. Now that's exactly how we see it from a commercial and future opportunity perspective as well.

It's really important to anticipate that suboptimal response does evolve over time, as Christelle mentioned. We are preparing and will work post-close with the Kartos team, and as we integrate into Ipsen, how we will prepare both the medical education.

As you might anticipate, this might be a very significant change also to the treatment paradigm. What we think is really novel is the opportunity to combine with Rux, which is such a mainstay of treatment.

We hope that with navtemadlin in combination with Rux, these patients are going to experience that sustained response over time and really improve the care for myelofibrosis patients. We're really optimistic, and we're very encouraged by the data that we see in terms of the trial operation.

Thank you.

Thank you, Raghuram. Operator, I understand we have another question?

Thanks a lot for taking my follow-up. Very quick one on corobotase.

You've mentioned the Phase II data to be sent here, maybe can you just remind us what's about this Phase II? What should we expect in term of data that are going to be reported before end of the year, and how meaningfully it'll incrementally it would be to get a better sense of the potential of corobotase in aesthetic indications?

Thank you very much.

Yep. The data before the end of the year is in aesthetics, in FHL and LCL.

As I said, we will also do then the stage 3 of that Phase II trial, which is going to combine glabellar line, FHL, and LCL. We are looking forward to the readouts of this first stage 2, and then continuing on the stage 3.

I think that was our last question, operator?

Thank you very much, everybody. Goodbye.