Ipsen Sa S/Adr

Hello and welcome to Ibsen's conference call and webcast on Q3 2026 results. I'll now hand you over to David Loew, Ibsen's CEO.

Thank you, operator. Good afternoon, everyone, and thank you for joining Ibsen'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 Ibsen's growing by 26.7%. Year-to-date sales grew 24.6% at constant exchange rates, with both our core portfolio and Somatilin delivering growth above 24%. Our core portfolio, which includes all MEDSINs, excluding somatoling group 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 disparate and chronic and episodic migraine. The ELSPIRE filing for an I-Corva label update is underway. The POISIS trial has recruited very well for NAFTA-Madeleine and the pivotal POTRAVITUR program is moving forward. Please turn to slide five. Turning to sales performance, third quarter sales reached 1.1 billion, growing 26.7% at constant exchange rates. Year-to-date sales reached 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 793 million of sales in Q3, up 23.3%, and 2.297 billion year to date, up 24.2%. This balanced performance is important. So Matalin 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 2.197 billion, up 16.3%. So Matalin grew 25.5 to 1.067 billion, benefiting from continued generic lanreotide shortages and supply constraints mainly in North America alongside solid demand in rest of world. Kapometics grew 15.6% to 523 million supported by solid performance across geographies in renal cell carcinoma and a growing contribution from neuroendocrine tumor launches in Europe. Onevite sales are flat despite the decrease in the US in the third quarter due to competition while the agenda launch is underway. Rare disease doubled to 498 million, Acorba reached 283 million, up 170.8%, and Bilwe reached 189 million, up 43.8%, as we can see continued momentum in our launches. Neuroscience sales reached 669 million, up 18.8%, led by disparate 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 Ibsen territories. These board 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 the 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 Onivite and Somatolin 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, naphthamadaline is in phase three for myelofibrosis, with the Poiesis readout expected in 2027. IPN 6340 is advancing in first-line unfit AML. In rarities, Corvo continues to expand its opportunity in PBC and in potent PSC, while Potravituk is moving into pivotal development for post-transplant nephropathy. In neuroscience, this sport has delivered positive phase 3 results in both chronic and episodic migraine, and regulatory submissions are on the way. Corobotase 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 Ibsen'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're building depth in solid tumors and hematology with more phase one assets to come into the clinic over the coming years. In rare disease, we're expanding beyond liver disease into post-transplant nephropathy. In neuroscience, we're 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 three poiesis redyed for naftimediline and myelofibrosis in 2027, alongside Firefly 2 for toforafenib. In neuroscience, we expect phase two readouts for Corobotes across therapeutics, followed by the first phase three aesthetics readout in 2028. In rare disease, we are progressing Proterbituk into pivotal development. These milestones give us multiple shots and 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 upgrades to our full year guidance. At the same time, we're 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 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. Thank you. We will now go to our first question.