Almirall, S.A.

Good morning to everyone on the call. Thank you for joining us to review Almiral's Q1 2024 financial results and business update. As per usual, you can find the slides to this call on the investor section of our website at almiral.com. Please move to slide number two. I would like to remind you that the information presented in this call contains forward-looking statements which involve known and unknown risks. uncertainties, and other factors that may cause actual results to materially differ. With that, please advance to slide number three. Presenting today, we have Carlos Gallardo, Chairman and Chief Executive Officer, Mike McGillan, Chief Financial Officer, and Kalsi Niravar, Chief Scientific Officer. Carlos will start with the Q1 2024 highlights, as well as an update on our biologic growth drivers as part of our path to leadership in medical departments. Carl will provide you with details on the progress of the pipeline before passing to Mike to review the financials in detail. Carlos will then conclude before opening up for a Q&A session. I would like now to pass it over to Carlos Ayarbo, our chairman and CEO, to commence with the quarterly highlights. Please move to slide number five.

Carlos Ayarbo Thank you, Pablo, and good morning to everyone in the call. Most of you will be familiar with our ambition to become a leader in medical dermatology. We have made significant progress in delivering innovative products to patients with skin conditions to truly impact their lives. And we remain fully dedicated to continue to create impact with our products and support patients and the medical community. 2024 is an important year for us in our progress to achieve our mission. And I'm pleased to report that Q1 was a promising start of this pivotal year for Alvirae. We continue to deliver business momentum based on our key growth drivers, and we are pleased with the trajectory of the growth of our broad portfolio as a foundation to achieve our ambition and business goals. Our key focus this year is on diligently executing the rollout of Eblis and to continue to progress our pipeline that is solely dedicated to medical dermatology. In light of our overall good business performance, we are confirming our full year guidance for 2024. In Q1, the performance of our business continues to be driven by our European dermatology business, underpinned by our recently launched products. We will of course dive into the performance of our portfolio in greater detail during the presentation, but let me touch upon a few highlights already to set the scene. Our biologic for psoriasis, Illumetri, continues to deliver impressive results across various geographies and has become a highly successful product within the medical dermatology market. Since the launch of Winthor and Clayseed in Europe, we have a steadily expanded presence in our market share in medical dermatology in key countries, with notable growth in Spain and Germany. And we have delivered solid rollouts across other European countries where, over the years, we have successfully expanded our footprint. We are also encouraged by the initial metrics of EPBLIS, our biologic for atopic dermatitis, launched in Germany. In Q1, we also made significant advancements in our pipeline. especially in the area of early-stage assets, which will fuel our future growth. Most recently, we announced a license agreement with Elux Pharmaceuticals for a read-through inducer. In February 2024, we successfully licensed the anti-IL-21 monoclonal antibody from Novo Nordisk, and both our anti-IL-1 wrap monochloric antibody and IL-2 mutafluorescein compounds are now in phase one. Please move on to slide seven for an update on biologics growth drivers. Let's take a closer look at the strong momentum of Illumetri, our anti-IL-23 psoriasis biologic in Europe. On the chart, we can see that Illumetri continues to display strong performance with 30% growth in Q1 to 49 million. The class, the NTIR23, also continues to gain market share and maintains its leadership position of new patients among biologics and psoriasis, which helps Illumetri growth, together with a balanced geographical performance. Germany remains a key market, and we continue to see healthy growth in the rest of European markets. New geographic launches are progressing nicely, driving growth further. We also successfully introduced a 200 milligram option without the injector, accompanied by comprehensive new clinical data in 2023, thereby providing additional value. All these factors reinforce our confidence that we are on track to achieve that 250 million pixels. Let me now move to EPCLIS. As we have mentioned in the past, we are convinced that EPCLIS has significant market potential as the best in-class treatment for atopic dermatitis. Its unique mechanism of action and overall strong profile set it apart from other treatment options that are currently available. The initial feedback we're getting from dermatologists and patients is aligned with the results of the clinical trials. The control of disease symptoms. The effectiveness as both a standalone treatment and when combined with topical glucocorticoids and a safety profile suitable for long-term management. All that means that Eblis can offer sustained efficacy and has the potential to significantly enhance the quality of life of treated patients. A particular benefit of Eblis is the four-weekly dosing regime in the maintenance period, which sets its support in the atopic dermatitis market. Also, the autoinjector enables patients to self-administer the treatment to enhance flexibility for patients and healthcare professionals. Let's please move to slide 9 to review the market data. Let me talk some more about the launch of EGIS in Germany and explain to you why we are excited about the progress we are making. Importantly, we are receiving very positive comments from both dermatologists and their patients. which are in line with the insights and data we have obtained in these few months after launch. There is already significant product awareness amongst the healthcare professionals, thanks to the work that our commercial teams have carried out to prepare and execute the launch in the market. This has led to everybody already capturing double digit share of dynamic patients as captured by ICPIA. As most of you know, this captures patients new to brand, both first-time users and switches. This is just after 10 weeks on the market, and it has surpassed all other advanced systemics, except for 2%, at the same point in the launch cycle. We are very pleased with this, and I know this data is only up to February. EPCLIS is also placed second in terms of intention to prescribe amongst first-line advanced therapies for patients with moderate to severe ectopic dermatitis. Again, this is based on the convincing positive results of the Phase III clinical studies and the excellent prelaunch activity. Amongst the initial feedback received from healthcare professionals and patients in Germany, I'd like to highlight three aspects. First, a substantial improvement in patients' quality of life as each inflammation level decreases after the treatment with Eblis. Second, the positive safety profile in line with what was shown in phase 3 clinical trials. Finally, the convenience of the less frequent four-weekly maintenance dosing appears to be playing a crucial role in patients' adherence to treatment. All in all, this positive feedback reinforces our conviction in the potential of Eblis. Next, please change to slide 10 to revisit the rollout plan. We are pleased that we have recently launched in Norway ahead of schedule, and we are on track for a launch in UK, Austria, Denmark, and Spain later this year. The rollout in remaining countries is expected during 2025. As we gain better visibility, we will keep you updated and refining these type notes. We are also very excited that Lilly has refiled their application for the BrichitoMaps market authorization to the FDA in the US. Next, please move to slide 12, where I invite Carl to give an update on our R&D work and the pipeline advances we have made in Q1, as well as giving some details on the excitement agreement we signed with Ellox Pharmaceuticals.

Thank you, Carlos, and good morning to everyone on the call. This slide shows you the progress of our pipeline. We continue to advance both our early and late stage pipeline. For CliSERI, we submitted a supplementary NDA in August 2023, addressing the expansion to large field in the US. We expect launch in the second half of 2024. In addition, he started a study aimed to enable the label expansion to large field in Europe with an expected launch in 2026. For Cysara in China, regulatory review is ongoing and approval is expected in 2024. Regarding the launch process, We recently signed a licensing agreement with a local partner. For efinoconazole, we are under regulatory review. We expect approval in the second half of 2024. The phase one studies for both our anti-IL-1 rep monoclonal antibody and our IL-2 mutin FC fusion protein are ongoing. In February this year, we in-licensed the monoclonal antibody targeting IL-21 from Novo Nordisk. IL-21 is a cytokine hypothesized to be involved in several immune-mediated diseases. We are currently starting to manufacture clinical supply to explore the utility of this mechanism in autoimmune skin diseases. Finally, in March, we in-licensed an oral re-through inducer for the treatment of rare skin diseases from Alox Pharmaceuticals. We plan to start phase one in the coming months. As you can see, we're making very good progress with both early and late stage pipeline and are on track to strengthen our leadership position in medical dermatology. now let's move to slide 14. let me share a few more details on the collaboration with elox zkn013 is a phase 1 ready oral read through inducer designed to overcome nonsense mutation that cause a premature stop codon resulting in non-functional protein production, for example, in recessive dystrophic epidermolysis bullosa, junctional epidermolysis bullosa, and familial adenomatous polyporesis. ZKN013 prevents the disruption of the protein production naturally seen in people with those premature termination codules. Premature termination codon mutations are mutations that, when inserted into a gene of interest, cause the termination of mRNA translation into protein by the ribosome. Thus, the protein synthesized is both truncated and nonfunctional, which causes the disease. Read-through drugs enable skipping such premature termination codon mutation by allowing the cell to ignore the mutation and make the full length protein as it should be. Almiral obtained exclusive global rights to develop and commercialize ZKN013 for the treatment of rare dermatological and other diseases associated with nonsense mutation. We are very excited about having these molecules now being part of our portfolio. With that, I will hand over to Mike for the financial review.