Almirall, S.A.

Good day and thank you for standing by. Welcome to the Admiral 9 Months 2024 Financial Results Conference School. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Pablo Dibasun. Please go ahead.

Thank you very much, Sonia. Good morning, everyone. Thank you for joining us for today's quarterly earnings update and review of Admiral's 2024 nine-month financial results. As always, we are sharing the slides we are using today in the investor section of our website at admiral.com. Please move to slide number two. Let me remind you that the information presented in this call contains forward-looking statements, which involve known and unknown risk, uncertainties, and other factors that make us act on results to materially differ from what we are sharing today. Please move to slide number three. Presenting today are Carlos Gallardo, Chairman and Chief Executive Officer, Mike McGillen, Chief Financial Officer, and Carl Singapur. start with the business highlights covering the first nine months of 2024 and will also give us an update specifically on our biologic portfolio as key growth drivers in our medical dermatology portfolio. Carl will provide you with an R&D status update highlighting the progress of our pipeline. And Mike will then talk you through the financials before Carlos closes and we open up for Q&A questions. I invite Carlos Gallardo, our chairman and CEO, to summarize our nine-month business overview. Please move to slide number five.

Thank you, Pablo, and hello, everyone. It's great to be here with you today and talk you through what has been a continued strong performance of Almirai in the first nine months of the year 2024. We have achieved solid results up until the end of September, delivering a net sales growth of almost 8% to a total of $728 million, with an EBITDA growth of almost 3%. This strong performance is fully in line with our expectations for the year, and we therefore reiterate our guidance for the full year. Our biologics portfolio remains a key driver of our continued business momentum, thanks to the execution and excellence of our teams in the markets, which also enabled us to achieve continued growth of our broader product portfolio beyond biologics. The balanced performance of our dermatology product portfolio, with a focus on biologics, continues to support and grow our leadership in medical dermatology. In 2024, we continue to focus on the launches and the growth of EPLIS across the European markets. Our launch schedule of EPLIS is on track, and we are seeing strong momentum of the product, particularly in Germany, where EPLIS is already established and is helping patients every day. We are also pleased with the progress of our medical dermatology R&D pipeline, which consists of a broad portfolio of assets that are designed to address significant and met needs, and are based on our leading scientific and technology expertise. Over the first three quarters of the year, our business performance has continued to be driven by our European dermatology business. In Europe, we have seen our growth accelerate throughout the year, led by the strong performance of our biologics portfolio and the continued growth of our broad medical dermatology branch. The majority of our growth comes from our most recently introduced products, which is a testament of the commercial excellence and executional strength that we have in our country teams. Let me explain this in more detail. Illumetri, our biologic product for psoriasis, continues to deliver strong performance and has become an important product in medical dermatology. This is a testament of our team's commercial excellence and our company's ability to achieve market success within the segments. Since launching Winthor and Glycerin in Europe, our presence and market share in medical dermatology have expanded significantly, particularly in key countries such as Spain, Germany and Italy. We are very encouraged by the positive development of the Eclipse sales performance at this early stage of market rollouts. We have now launched in Germany, Norway, UK, Spain, Denmark, and the Czech Republic, and we are on track with our preparation of upcoming launches. I'll go into more details of Eclipse later. Progressing our R&D pipeline is at the heart of our company strategy. We are pleased with our recent steps ahead of advancing our pipeline throughout the first nine months of the year. We have achieved two milestones in our late-stage pipeline recently. After the FDA approval, we have already launched glycerin large field in the U.S., which gives dermatologists a powerful alternative to treat patients with larger areas affected by acne keratosis. In Europe, we have recently completed the decentralized regulatory procedure for a feconazole, which is a complementary asset to treat onychomycosis, an especially persistent condition that still has significant unmet need. In the early stage pipelines, we have also made significant progress in the year to date. This is the basis for us to drive future growth of our medical dermatology business. Carl will give more details on our pipeline progress in a little while. In addition to our current pipeline assets, we continue to evaluate external opportunities across the early and mid stages of clinical development. Our strategy continues to focus on assessing collaborations and agreements based on the scientific, strategic, and financial parameters. Our close collaborations with the medical community are a cornerstone of our strategy and embedded in the heritage of our company. In addition to our many direct interactions through our teams across different functions, our conference presence is central to that approach. This year, we had a strong presence at the 33rd Congress of the European Academy of Dermatology and Pneumatology, EADB, in Amsterdam, which was focused on our biologic portfolio and was a key activity to support the launch of iBLIS. We presented 34 abstracts detailing the latest research on nebrikythumab for moderate to severe atopic dermatitis in adolescents and adults, Tildrakizumab and Almirai-Cathipotrien betamethasone cream for moderate to severe plaque psoriasis in adults, as well as Tervanibulin for acne keratosis. In October, the results of two additional studies related to EPLIS were presented in the full clinical conference. Carl will explain this important data in more detail later in the course. Please move on to slide seven for an update on our biologics portfolio. Let's dive a little deeper into the continued strong performance of Illumetri, our anti-IL-23 biologic for psoriasis in Europe. Illumetri has grown in line with our expectations and now holds a strong position and continues to gain market share in key countries across Europe. In the first nine months of 2024, Elometry grew 25% year-on-year, reaching sales of around 153 million. As usual, we experienced a recurring summer seasonality, but sales still reached a robust 52 million in the quarter. The anti-IL-23 class not only continues to lead in advanced therapies within the dynamic psoriasis market, but it is also the fastest-growing class within the Soraya Seas market. This strong performance is an excellent basis for Illumetri continued growth, along with a balanced performance across the different countries in Europe. Germany continues to be the strongest market for Illumetri, and in addition, we are seeing strong growth in other European countries, reaching important market milestones. For example, Illumetri is now the leader in the dynamic market of branded biologics for psoriasis treatment in Italy for the first time. Also, the recent launch of the 200 mg option for Illumetri gives dermatologists a unique opportunity to treat a broader segment of patients and also to contribute to increase Illumetri's market share. Additionally, new real-world evidence on the performance helps drive awareness of the strength of Illumetri. We presented new 52-week interim data on the positive study at the September EADV Congress, demonstrating the improvement in overall well-being of patients with moderate to severe psoriasis in addition to the improvement of the physical symptoms. Having achieved a run rate figure of 200 million based on September sales, we remain confident in achieving the 250 million pixel target. Please move on to slide eight for an update on the EGLIS launch, our new biologic treatment for moderate to severe topic dermatitis. We are very pleased with the progress of EGLIS in the first nine months of 2024. The strong performance of EGLIS shows the potential of the treatment to impact patients and the opportunities this creates for us as a company. This performance is testament to the product and to our Eplis continues its positive performance trajectory. In quarter three, it grew 34% quarter-on-quarter, reaching a sales total of 10 million and delivering nine-month sales of just over 20 million. Please note that these 20 million are mainly German sales. Although we have already launched Eplis in other countries, we're still going through the market access phase to get our product in the hospitals. So there is a limited amount of sales coming from these remaining countries as of today. as expected. The awareness of Eblis amongst healthcare professionals has increased significantly since launch and is further growing on a quarterly basis. Prescriptions to treat moderate severe atopic dermatitis in Germany are steadily increasing with Eblis continuing to gain significant share in the dynamic market segment. Overall, we are very proud of the feedback we continue to get from patients and physicians about the product. EPGLIS continues to grow with a strong position in the market and demonstrates its role as new first-line treatment based on the strong efficacy and favorable safety profile. Let's move on to the next slide, please. Our EPGLIS launch plan in Europe is on track, and we are pleased with the significant progress we have made this year already since the launch in Germany in December 2023. After our launches in Norway and UK, we have recently made EPLIS accessible in Spain, Denmark, and Czech Republic, where the product is available for commercial reimbursement. Most recently, we have also received regulatory approval of EPLIS in Switzerland and expect a reimbursement decision in 2025, in line with the standard process timings in Switzerland. We are now anticipating that EPLIS will be available in Austria at the beginning of the next year. instead of late 2024. Also, in 2025, we will focus on rolling out EPLIS in the remaining European countries. We will, of course, keep you updated on our progress in these launches. After receiving the FDA approval in the US, our partner Lilly has recently launched in the US, Canada, Japan, United Arab Emirates, which demonstrates the potential of the brand to become a global powerhouse in the treatment of ADD. The growth of EPLIS is further supported by ongoing clinical trials, additional launches, and by the opportunity to generate real-world evidence of the impact of the product. Next, please move on to slide 11. I invite Carl to give us an update on the positive progress in R&D and our pipeline.