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Almirall, S.A.
5/12/2025
Thank you for joining us for today's quarterly earnings update and review of Almiral's first quarter financial results of 2025. As always, we are sharing the slides we are using today in the investor section of our website at almiral.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 risks. uncertainties, and other factors that may cause actual 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 McKellan, Chief Financial Officer, and Carl Sigabar, Chief Scientific Officer. Carlos will start with the business highlights covering the first quarter of 2025. followed by an update especially on biologics as the key growth drivers on our medical dermatology portfolio. Carl will provide you with an R&D status update regarding our pipeline. And Mike will then talk you through the financials before Carlos concludes the presentation. And we open for questions. I will hand over to Carlos Gallardo, our chairman and CEO. Please move to slide number five.
Thank you, Pablo. We are delighted to share with you that we have started the year with continued strong business performance that is very much aligned with the long-term trajectory of sustained growth we have outlined for Foral Mirai recently. Therefore, we are pleased to confirm our full year guidance for 2025, our mid-term outlook and pictures projections. This represents another quarter in the right direction in our ambition to transform the life of pay Euclid delivered a strong peak sales during the first quarter of 2025, benefiting from the dynamic German market, but also from initial contributions from launches in additional countries. Illumetri continues to show year-on-year growth, and we confirm our recently updated peak sales projections. Additionally, we thought Ancai City continued to support our sales in Europe. We remain very active in the medical community, and this first quarter has not been an exception. As an illustration, we've been at the 2025 Annual American Academy of Dermatology meeting, where we showcased our success in AK treatment with Clive City and shared exciting Phase I data on our anti-IL-1 wrap. We were also present at the 16th Skin Academy in Barcelona. This is our flagship medical educational event. where we had over 800 delegates from different countries. We participated on the 11th World Congress of Melanoma and the 21st European Organization of Thermal Oncology Congress in Athens, hosting over 1200 healthcare professionals. This is very important for us, this interaction with medical professionals, and we constantly seek external opportunities and the early and mid stages of clinical development to enhance our portfolio and impact the dermatology field. Please move to slide seven for an update on our biologics portfolio. Illumetri and the IL-23 class have continued to secure a strong position in the psoriasis market. Illumetri's market share remains solid, underpinned by the recent introduction of the 200 milligram presentation. This new treatment option has been very well received and is contributing to our robust performance. Net sales for Illumetri are up 13% year-on-year, reaching 55 million in the first quarter of 2025. I would like to reiterate our recently upgraded pixel projection of over 300 million and underscore our confidence on Illumetri's continued growth and its potential to make a significant impact in the psoriasis treatment landscape. Please move to the next slide on Eblis for Eblis highlights. Eblis have shown strong performance after being on the market for just over a year. Starting with the December 2020 launch in Germany, cumulative sales since then have reached over 54 million. We consider this the best launch in atopic dermatitis in recent years. Our strategic focus has allowed us for a strong initial uptick in Germany, positioning us well to launch in other European markets. Within a year of launch, we have reached the second highest dynamic new patient share in Germany. Also, reimbursement pricing in Germany and in other countries is either in line with our expectations or even slightly better, and brand awareness is strong, exceeding the average within one year of launching in various markets. Sales in the first quarter increased by 52%, quarter on quarter, reaching 19.4 million euros. Driven largely by Germany, but as I said before, also we're seeing the contribution of recently launched regions beyond Germany. Our good partnership with Lilly is leading to fruitful exchanges and key learnings. Let's move to the next slide for more details on the launch timeline. has already been launched now in all key countries in Europe, which combined represent more than 90% of the total sales potential in the region. We are progressing with launches in new European markets and have seen significant advancements since the German launch back in December 2023. As of today, EBIT is available for commercial reimbursement in 13 countries in Europe, including France as of last month, April 2025. We are very excited about this new launch as France represents a very important market for us. It is important to re-emphasize that we have been able to secure solid price levels in the launch markets. This is a prime example of how the desire for alternative treatments in atopic dermatitis is significant in the different national healthcare systems. Next, please move to slide 11 where I invite Carl to give us an update on our positive R&D and pipeline progress.
Thank you, Carlos, and good morning, everyone on the call. This slide shows you the progress of our pipeline. Saracycline's regulatory review in China is ongoing. We expect approval in the second half of 2025. For glycerin expansion to large field in Europe, we are finishing a clinical study aiming to launch in 2026. Together with our partners, we continue to work on expanding the labels for our key products, Illumetri and Epclif. Our partners and pharma is running two phase three studies to assess efficacy and safety of Tiltrakisumab in patients suffering from psoriatic arthritis. First results are being expected in the second half of 2025. Together with our partner, Eli Lilly, we are running a joint clinical development program to make EPCLIS available to additional patient population. I will give more details on the next slide. We have created an exciting early clinical pipeline, addressing novel mechanisms and best-in-class compounds in high medical need diseases. In the next year, we plan to initiate four proof-of-concept Phase II clinical studies across a spectrum of different dermatological diseases. Let me highlight a few assets. For our anti-IL-1 rep monoclonal antibody, we have completed Phase I single and ascending doses in healthy volunteers and presented the results at the recent AAD meeting. Overall, our anti-ALVA and RAP monoclonal antibody demonstrated a favorable safety and tolerability profile in healthy volunteers, along with a low immunogenicity risk supporting its further development for the treatment of immune-mediated inflammatory skin disorders. We plan to start a phase two study later this year in Hidradenitis suppurativa. Let me also highlight that we are advancing ZKN013 in phase one as potential new treatment for severe dermatological indications, such as dystrophic epidermolysis bullosa and junctional epidermolysis bullosa. ZKN013 is an oral read-through inducer designed to overcome nonsense mutation that cause a premature stop codon. In summary, we are progressing with both our early and late stage pipeline. Now, let's move to slide 12. This slide shows the comprehensive joint clinical development program for leprechaun with our partner, Eli Lilly. This joint program will allow us to make leprechaun available to additional patient populations or in different settings. Let me highlight some of the studies. This year, in all European markets, we will complement our excellent clinical data package with real-world evidence studies. One example is the so-called AD Trust Study I highlighted in the last call. To make leprechaun available to all patients with atopic dermatitis, Our partner Eli Lilly is running a phase three study exploring the safety and efficacy of leprechaun in patients six months to under 18 years. Primary completion is expected in 2026. Furthermore, our partner Eli Lilly has started the ADTouch study. Exploring efficacy and safety of leprechaun in adults and adolescents with moderate to severe atopic hand and foot dermatitis. Atopic hand and foot dermatitis is a frequent, chronic, and difficult to treat condition. It can substantially impact the patient's quality of life. There is tremendous interest from academic investigators in further exploring leprechaun map in different indications or settings. For example, Professor Johann Hutchinson from University of Michigan, a leading expert in applying genomics technology to advance the molecular understanding of inflammatory skin diseases, will be the lead investigator for the so-called AD5 study. AD-FIND is a mechanistic study aimed at understanding at the cellular and molecular level the changes in the skin of patients suffering from moderate to severe atopic dermatitis when treated with leprechaun. Finally, in addition to the two studies in perennial allergic rhinitis and chronic rhinocytosis with nasal polyps, our partner Eli Lilly is running, we continue to explore new indications for which R13 is hypothesized to be a key pathogenic drive. With that, I will hand over to Mike for the financial review.
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