5/8/2023

speaker
Pablo [Last Name Unknown]
Investor Relations Representative / Call Host

Good morning to everyone on the call. Thank you for joining us to review Almiral's Q1 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 two. I would like to remind you that the information presented in this call contains forward-looking statements which involve known and unknown risk, uncertainties, and other factors that may cause actual results to materially differ. With that, please advance to slide three. Presenting today, we have Carlos Gallardo, Chairman and Chief Executive Officer, Mike McKillen, Chief Financial Officer, and Carl Singelberg, Chief Scientific Officer. Carlos will start with the highlights, biologic growth drivers and key products. Carl will provide you with details on the progress of the pipeline before passing to Mike to review the financials. Carlos will then make the closing comments before opening up for a Q&A session. I would like now to pass it over to Carlos Gallardo, our chairman CEO, to discuss the quarterly highlights. Please move to slide number five.

speaker
Carlos Gallardo
Chairman and Chief Executive Officer

Thank you, Pablo, and good morning, everyone. I am pleased to say that Almirai is off to a good start from both financial and pipeline perspectives. The strong business momentum from our growth drivers continues. while we continue to prepare for Leverikizumab's launch. Based on the good business performance in quarter one, we are reiterating our full year 2023 guidance. The performance of the business was driven primarily by our European Dramatology business, underpinned by our recently launched products that I will discuss more later in the presentation. Let me highlight the performance of some of those. We continue to see strong performance from Illumetri across geographies with continued good uptake in Germany and solid contribution from recent country launches. Since the launch of Windsor and Clay City in Europe, we continued increasing market share in key countries, particularly in Spain and Germany for both products while making excellent progress with the rollouts in other European geographies. We also continue to work on the pipeline with positive clinical updates on lebrichizumab. Our Advantage Phase III B-Market Access Study Headline results are available and show positive results. Carl will shed more light on this later in the presentation. We continue to work with our partner, Eli Lilly, towards a targeted late 2023 European approval and launch soon thereafter. CLI-CD large field study has shown that the administration of CLI-CD in a surface of up to 100 square centimeters has been well tolerated. Finally, in the early stage pipeline, the phase one study of our anti-IL-1 wrap is ongoing, and we expect to launch phase one for IL-2 mutine during that year. Now, let's move to slide seven for a deeper dive on leveraging. In terms of key events, let me quickly revisit the timeline of the milestones. leading us to the expected approval later this year. During this first quarter of the year, the ADVOCATE and ADHERED studies were finally published in scientific journals. Another important milestone ahead of the launch has been completed recently, as we obtained positive headline results for the ADVANTAGE phase 3b study. We are positive on the good clinical development of lebrichizumab and confident on the expected approval of the product towards the end of the year. as we intensify the efforts to be prepared for a successful commercial launch. Let's move to the next slide to discuss the advantage in more detail. The Advantage Study headline data is already available, achieving positive results. Safety was consistent with the known profile of lebrichizumab. As a reminder, the Advantage Study is a randomized, double-blind, placebo-controlled, Phase III clinical trial to assess the efficacy and safety of lebrichizumab 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. Let's move to the next slide to discuss Illumetri a little bit in further detail. On the left side, you can see the market dynamics of the anti-IL-23 class in Germany, where the class continues to lead in new patients' market share. There is a small decline in February, possibly impacted in part by a similar center in the market. But the IL-23 trend remains robust, with around 40% market share of new patients within biologics. As you can see on the right side chart, Illumetri continued to demonstrate strong performance during the quarter, with net sales of 38 million in this first quarter of 2023. The contribution of other European countries compared to Germany continues to grow and now stands at around 50%, a trend we expect to continue. Overall, we are pleased with Illumetri's continued growth and we expect a good level of performance to carry on for the rest of the year.

speaker
[Name Unknown]
Slide Coordinator / Conference Call Facilitator

Now let's move to the next slide to complete the update on other key products. Let's start with Aishara.

Disclaimer

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