Ipsen Sa S/Adr

Hello and welcome to Ibsen's conference call and webcast for the first quarter 2025 results. I'll now hand you over to David Lowe, Ibsen's CEO.

Thank you and hello everyone. I'm delighted to welcome you to our Q1 sales presentation this afternoon, which can also be found on Ibsen.com. Please turn to slide two. Please take note of our forward-looking statements, which outline the routine risks and uncertainties contained within this presentation. Also, any of my commentary on growth will be based on constant exchange rates. Please turn to slide three. I'm going to take you through our sales performance of the first quarter and provide you with a business update after which our CFO, Emmerich Le Chatelier, will join me for the question and answer session. Let's begin by looking at today's highlights. Please turn to slide four. We continued to deliver a strong top-line growth in quarter one. Total sales grew by 11.6%, driven by all three therapeutic areas, and including an increase in contribution from my Corvo and Bill Bay. Since the beginning of the year, we have made good progress with our pipeline, including the EMA regulatory submission of tovorafenib for pediatric low-grade glioma, the entry in phase one of a third-generation RAF inhibitor, complementing our ERK inhibitor with both being in the clinic. On the financing side, we announced in March a successful refinancing of 2 billion, including a 500 billion rated public bond supported by investment grade ratings from Standard & Poor's and Moody's. This provides long-term funding of the firepower for our external innovation strategy. Looking ahead, 2025 promises to be another exciting year for our pipeline with several key milestones, including the expected decision from the EMA for cabometrics in neuroendocrine tumors in Europe, fit-resertive pivotal data in fibrodiplasia ossificans progressiva, or FOP, and the first proof-of-concept data for our long-acting neurotoxin in aesthetics. Lastly, we confirmed today our 2025 guidance with total sales growth greater than 5% at constant exchange rate and a core operating margin greater than 30% of sales. Please turn to slide 5. All three therapeutic areas have seen strong growth in this quarter. Oncology has performed well, growing by 8%, driven by the strong performance of somatolin. Rare disease continues to stand out, propelled by the sustained performance of Bilvay and Alcorva launches. Neuroscience, comprising this word, delivered strong and consistent growth, close to double digits. And now I'll turn to oncology for more detail. Please turn to slide six. Starting with somatolin, sales were up 19% in the first quarter, with good performance in the U.S., Europe, and rest of the world. This growth reflects the continued shortages of generic lanreotide in the U.S. and Europe. During the quarter, we saw some limited signs of generic lanreotide supply progressively recovering in the U.S. and Europe, still with some inconsistency. Sun Pharma, along with its partners, Biatris and Centiva, have received several local approvals following the decentralized procedure, but have not yet launched. Approval in the U.S. is still expected later this year. Carbometrics sales were down by 3%, driven by a very high 2024 baseline, as well as price pressure in some rest of the world markets. However, carbometrics performance was strong in Europe, with increased volumes in both first- and second-line renal cell carcinoma. Decafeptil was back to growth in quarter one, with sales up by 3.4%, driven by solid volume growth in Europe and China, despite continuous competition and pricing pressure. Only by sales rose by 6.3%, with a limited market share growth in the U.S. in the first-line metastatic pancreatic ductal adenocarcinoma indication. We continue to work on driving first-line differentiation and on addressing some challenges with access to payers that we have been facing since the start of the year. Now, let's turn to rare disease. Please turn to slide 7. On rare disease, Bilbao continues to perform nicely with Q1 sales of 43 million, representing growth of 63%. This performance was driven by increased sales in the U.S. in the PFIC indication, where we enjoy a strong leadership position, and in allogile syndrome with uptake from naive and switch patients. We also see a strong momentum in Europe, mainly driven by the PFIC indication and market expansions. Turning to iCorvo, the launch continues to track well in line with our expectations, with sales reaching 23 million this quarter. The growth in the U.S. was driven by an increasing patient uptake from new patients and patient switches from Ocaliba. Additionally, I'm also pleased by the successful launches in Germany and the U.K., contributing to the strong performance. We're expecting more countries to launch in 2025. Moving to neuroscience, let's turn to slide eight. This point delivered another solid performance with sales growth of 9.6% for the quarter. In aesthetics, sales grew by 16%, driven by continued expansion in most territories, including the US, Europe, and rest of the world. On the therapeutic side, reported sales were flat despite the solid growth in North America and Europe, offset by shipping phasing and high 2024 baseline in Brazil. Moving to the pipeline, please turn to slide nine. You can see our well-balanced portfolio that continues to grow across the therapeutic areas and phases of clinical development. As I mentioned earlier, in our oncology portfolio this quarter, toporafenib was accepted by EMAI for review. marking an important step forward in the development of this potential treatment for pediatric low-grade glioma and reinforcing Ipsen's commitment to innovation in rare and difficult-to-treat cancers. I'm pleased to see that a third-generation RAF inhibitor from our preclinical pipeline has entered Phase I trial. This asset will reinforce our ERK inhibitor and tocorafenib, two other assets targeting the MAPK pathway. We are anticipating more preclinical assets to progress this year and in the near future. I would also like to draw your attention to the IQURBO Elmwood Phase 2 trial results in PSC, which are going to be presented in a late-breaking session at easel beginning of May. Now, I would like to share more about our upcoming data readouts this year. Please turn to slide 10. There are a lot of exciting milestones that we expect this year and next year. Let's focus on 2025. First, in oncology, we are expecting a decision from the European authorities on copometrics in pancreatic and extrapancreatic neuroendocrine tumors. In rare disease, we are looking forward to the readout of FALCON, our registrational phase 2 study with Fidricertib in FOP. Lastly, we anticipate the first proof of concept data for our long-acting neurotoxin anesthetics. We believe LAND has the potential to deliver better outcomes for patients with an increased duration of action, leading to a reduction in injection frequency. In that context, I'm delighted that Olivia Bryan recently joined our executive team to help build an integrating neurotoxin franchise and drive and accelerate our development growth and innovation in neurotoxins, both in the therapeutic and aesthetic space. I will now move to conclusion at LiveLook for 2025. Please move to slide 11. Ibsen has delivered a strong start to 2025. We are on track to build further momentum in our transformation and to achieve our objectives for the year. Our top line continues to deliver, driven by the launches and continued portfolio performance. We are increasing our investment in our launches and our preparations for upcoming milestones as we advance our pipeline. To further strengthen our pipeline, we will continue to diligently evaluate external innovations, leveraging our firepower. With that, please turn to slide 12. This concludes our presentation, Emerick, and I will now take your questions. Operator, over to you.

Thank you. To ask a question, you'll need to press star 1 and 1 on your telephone and wait for your name to be announced. And to withdraw your question, please press star 1 1 again. That's star 1 and 1 for any questions. Thank you. We'll now take our first question. This is from the line of Shan Hammer from Jefferies. Please go ahead.