Almirall, S.A.

Good morning to everyone on the call. Thank you for joining us to review Almiral's nine months 2023 results and business update. As per usual, you can find the slides to this call on the investor's page 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 and risk, 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 McKillen, Chief Financial Officer, and Carl Singerbar, Chief Scientific Officer. Carlos will start with the highlights, Biologic Road Drivers and Recent Launches. Carl will provide you with details on the process of the panel before passing to Mike to review the financials. Carlos will then conclude the closing comments before opening up for a Q&A session. I would now like to pass it over to Carlos Gallardo, our chairman and CEO, to discuss the highlights. Please move to slide number five.

Carlos Gallardo Thank you, Pablo, and good morning to everyone in the call. I am pleased to say that Almiray continues to perform well through the first nine months of 2023. the business momentum from our growth drivers remain solid. Based on the good business performance year-to-date, we are nudging up our net sales guidance for full-year guidance, and we continue to expect to land in the middle of the range for the EBITDA guidance. The nine-month performance was driven primarily by our European dermatology business with a growth rate of almost 16%, underpinned by Illumetri and our recently launched products. Winzora, and Clicidi. Moving to key pipeline highlights, on September 15th, the CHMP of the European Medicines Agency issued a positive opinion recommending the marketing authorization of Eplis, which is the brand name for Lebrechizumab. Still in our late-stage pipeline, Clicidi Large Field Supplementary NDA in the U.S. was submitted this quarter. the launch is anticipated in the second half of 2024. For the rest of our portfolio, the CESARA dossier in China was submitted during the third quarter and we're expecting launch in 2024. And for EFICON as well, the regulatory review is ongoing and we expect the approval by the second half of 2024. Carl will elaborate on all this in more detail. Regarding the use of the proceeds of the capital increase of June, I am pleased to announce our first deal, the acquisition of the rights of Prometax in Spain, which is a perfect bolt-on for our neurology division in Spain. We are confident on our ability to drive commercial success for Prometax and to create value for the company. Please move on to the biologics growth drivers update on slide seven. As I mentioned before, Last September, the European Medicines Agency, CHMP, issued a positive opinion recommending the marketing authorization of Epilis. At this stage, we do not expect any delay in Europe related to the FDA CRL in the US. We continue working towards our existing timeline and to launch the product as expected at the end of the year. The commercial teams for the initial country launches are already in place and fully prepared for the rollout, in particular in Germany, where we expect a quick turnaround between approval and launch, and where we are very pleased with the level of awareness of the product within the dermatology community. Let's move to slide eight, please. Let's now take a closer look at the strong momentum of Illumetri, our anti-IL-23 biologic for psoriasis in Europe. I would first like to highlight that the anti-IL-23 class continues to maintain its leading market share of new patients amongst biologicals. As you can see here in the left map, the rollout process in Europe is well underway. We have launched a 200 milligram presentation, the autoinjector, and provided new clinical data. On the right side chart, we see that Illumetri is performing strongly in the first nine months, despite the usual summer softness. It also shows a more balanced growth with the sales contribution of other European countries that now already represent already a 50%, with Germany making up the other half. This demonstrates the good traction of the product in other key European markets where it has been launched. We expect Q4 to resume momentum, and we continue to expect full-year growth in absolute terms to be comparable to 2022. Now let's move to slide 10 to complete the updates on our recent thermal launches. Let's start with CliCity, where sales grew by 57% for the first nine months. In Europe, the product has seen solid adoption in key markets, with expansion in market share. In the US, we continue to differentiate CliCity from what is already available on the market based on efficacy, tolerability, and convenience. As a result, both dermatologists and patients report high overall level of satisfaction and willingness to repeat treatment with CliCity. We will soon reinforce the franchise with the launch of Clyde City Large Field, which is anticipated in the second half of 2024 in the US and in 2026 in Europe. Moving into Windsor in Europe, we are pleased with the progress, having achieved sales of around 12 million in the first nine months of the year, with solid share in Spain and Germany. With that, let me pass the word to Carl to cover our pipeline section.

Thank you, Carlos, and good morning from my side. This slide shows you the progress of our pipeline. We continue to advance both our early and late-stage pipeline, starting with leprechaun epclis. As already mentioned, we received a positive CHMP opinion on the marketing approval of epclis, and I will share more details on the regulatory status across Europe on the next slide. For Glyceri, we have completed the clinical study addressing the expansion to large field in the U.S. and submitted a supplementary NDA in August 2023. We expect launch in the second half of 2024. For Cythera in China, the phase three clinical study met primary and key secondary endpoint, and we submitted a dossier to the Chinese National Medical Products Administration at the end of September 2023. Approval is expected in 2024 in about 12 to 18 months. For efinaconazole, we are under regulatory review. We are facing delays in this regulatory process and expect now approval in the second half of 2024. The phase one of our anti-IL-1 rep monoclonal antibody is ongoing, and we aim to start phase one for our IL-2 new TNFC fusion protein that we developed in collaboration with CIMSIA later this year. As you can see, we are making very good progress with both our early and late stage pipeline, and we are on track to strengthen our leadership position in medical dermatology. Let's move to slide 13. On this slide, I would like to share the regulatory status of EFCLIS across Europe. We already covered the status in the European Union. As a reminder, we received a positive CHMP opinion on September 15th and expect European Commission approval by the end of November 2023. Regarding the United Kingdom, we submitted a marketing authorization application, MAA, in September 23. The approval from MHRA is expected by the end of the year, following the EC reliance procedure. In Switzerland, we submitted the MAA in June 2023, and the approval is expected by the end of 24. In addition to the progress in regulatory, we are extremely excited about the continuous flow of positive clinical data for lepricizumab. And I would like to share a few examples on the following three slides. Please move to slide 14. We published the results of the Advantage Phase 3b study at the recent European Academy of Dermatology and Venerology EADV Congress. As a reminder, the ADVANTAGE study is a randomized, double-blind, placebo-controlled phase 3 clinical trial to assess the efficacy and safety of lepricizumab in combination with topical corticosteroids in adult and adolescent patients with moderate to severe atopic dermatitis who are not adequately controlled with cyclosporine A or for whom cyclosporine A is medically not advisable. The study met the primary endpoint at week 16. At week 16, leprechizumab, 250 milligram every two weeks, plus TCS significantly improved signs and symptoms of AD measured by the eczema area and severity index 75%, EC75, in 68.4% of patients, while only 40.8% of patients on placebo plus TCS achieved EC75. Consistent benefit was also seen in additional endpoints such as EC90 investigator global assessment score, IGA, or purities measured by the numeric rating scale, NRS. The safety profile was consistent with a known safety profile of lubricism. Another example is shown on slide 15. Additional data presented at the EADV Congress showed sustained depth of response in patients that participated in the phase 3 monotherapy advocate 1 in 2 studies treated with leprechizumab over 52 weeks. Deep responses defined as total skin clearance EC100 and each relief of NRS 0 or 1 were achieved in 20 and 31% of patients, respectively, by week 16. These values were either maintained or even improved by week 52. These results suggest that leprechaun treatment can potentially allow patients and healthcare providers to elevate their expected treatment goals in ID beyond EC75 response. A third example is shown on slide 16. At the 43rd Annual Fall Clinical Dermatology Conference held in Las Vegas from October 19th to 22nd, our partner Eli Lilly presented the first results of the long-term extension study ACHOIN, which represented patients with moderate to severe atopic dermatitis who continue treatment with leprechizumab for up to two years and experience sustained skin clearance, itch relief, and reduced disease severity with monthly maintenance dosing. ACHOIN is a long-term extension of the leprechizumab monotherapy trials Advocate 1 and 2, and the combination study with topical corticosteroids Adhere. Patients taking lepricizumab who achieved IgA01 or EC75 at week 16 in advocate 1 and 2 and a tier were enrolled in a joint. Patients in the long-term extension trial received either 250 mg lepricizumab every two weeks or monthly after being rolled over from advocate 1 or 2 at week 52 or from a tier at week 16. As shown in the table, in a joint extension following Advocate 1 and 2, 76% of patients dosed every four weeks and 86% of patients dosed every two weeks maintained clear or almost clear skin, IgA 0 or 1, at two years of treatment. 96% of patients dosed every four weeks and 96% of patients dosed every two weeks maintained EC75. 83% of patients dosed every four weeks and 82% of patients dosed every two weeks maintained EC90. 90% of patients dosed every four weeks and 100% of patients dosed every two weeks maintained clinically meaningful reduction in each as measured by a 4.0 large reduction on the each severity on the PURITIS NRS at two years of treatment. In a joint extension following a tear, lepricizumab demonstrated similar results, as you can see at the right side of this table. The safety profile of lepricizumab in a joint was consistent with previous lepricizumab studies in patients with moderate to severe atopic dermatitis. These data are very reassuring and give us confidence that leprechizumab has the potential to be a first-line biologic and may support less frequent dosing during the maintenance phase. In summary, we continue to be extremely excited about leprechizumab and are confident on the expected approval and launch of leprechizumab towards year end. With that, I will hand over to Mike for the financial review.