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Almirall, S.A.
7/24/2023
23, 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 risk, uncertainties, and other factors that make us add to our 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 Singapur, Chief Scientific Officer. Carl will start with the highlights, Geologic Growth Drivers and Key Products. Carl will provide you with details on the progress of the pilot before passing to Mike to review the financial and the closing comments before opening up for a Q&A session. I will now To pass it over to Carlos Gallardo, our chairman and CEO, to discuss the highlights. Please move to slide number five.
Thank you, Pablo. I am pleased to say that Almirai's positive trajectory continues in the first half of the year. The business momentum from our growth drivers remains solid. Based on the good business performance, we are reiterating our full year 2023 guidance. We are on track to land in the upper end of the sales guidance and mid-range of the EBITDA guidance. The performance was driven primarily by our European dermatology business that showed 15% growth underpinned by Illumetri and our recently launched products. This will be discussed in more detail later in the presentation, but let me touch upon a few highlights. Let me begin with Illumetri. Our product continues to see strong performance across geographies, with continued good uptake in Germany and solid contribution from recently launched countries. Launching with Zora and Glycity in Europe has helped drive continued growth in key countries, particularly in Spain and Germany, for both products, while we also make excellent progress with their rollouts in other European countries. Regarding lebrichizumab, we continue to work with our partner Lilly towards a targeted late 2023 European approval and launch soon thereafter. Glycerin large field study showed it was well tolerated and a supplemental new drug application based on the phase three study is expected by the second half of the year, with a launch anticipated in the US in the second half of 2024. In the early stage pipeline, the phase one study of our anti-IL-1 wrap is ongoing, and we expect to start phase one for the IL-2 mutine during the year. Finally, during the second quarter, we successfully closed a capital increase of 200 million euros, which will give us financial flexibility and agility in actively pursuing and swiftly executing inorganic growth opportunities. including both acquisitions and licensing opportunities that are currently under analysis. Since I am traveling this morning, I might not be able to participate in the Q&A session later in this webcast. So as probably there will be questions from this point, allow me to elaborate a little bit more on the use of proceeds of the capital increase. There are three areas we are focusing on, mainly in Europe. Firstly, Both are acquisitions that we can incorporate rapidly with minimal business disruption. Primary care business over the country in Spain or Germany. Good examples will be our acquisition of Crestor in Spain and PhysioRelax earlier in 2023. A second area of focus will be in licensing opportunities to fill the pipeline with early stage assets. Our examples will be designed in licensing deals with IGNOS and Sincere. As for the indication areas, we are looking at immune-mediated inflammatory skin diseases like dermatitis, non-melanoma skin cancer areas like basal cell carcinoma and squamous cell carcinoma, and rare dermatological diseases. Finally, these opportunities should have global rights and ideally explore multiple potential indications. As a third area of focus, we will also look at licensing deals for late-stage assets. We have a good licensing history for both big and small products. For instance, both Illumetri and LibriKithumab in terms of bigger products and Winthor and Klycity in terms of small products. Let me finish by saying that we are very pleased by the support in this capital increase from our shareholders, including the Gallardo family. As I said before, I will be available later if finally I cannot participate in the Q&A for traveling reasons. Let's now move to slide seven to comment on Lebrikizumov. We are now closer to Lebrikizumov's potential approval in late 2023, which we anticipate following a potential positive CHMP opinion. Ahead of this, let me update you on some of the remaining events linked up to the launch. On top of the other studies we have completed, We have also initiated an extension study to explore the long-term benefits of lebrichithumab for up to five years. We believe that atopic dermatitis is a chronic disease that requires long-term treatment. We think that lebrichithumab has the potential to control AD effectively with every four weeks dosing in the maintenance phase as shown in our advocate studies. In addition to that, our partner Lilly is conducting additional studies. For instance, ADAPT, a study in patients who have been previously exposed to dupixent. Another study is ADMIRABLE, which is focused on patients with skin of color. And finally, ADORABLE, a pediatric study. Meanwhile, ADMIRABLE continues to prepare and plan for lebrichithumab rollout in Europe once we receive approval later this year. Let's move to slide eight, please. Let's take a closer look at the strong momentum of volumetric. our anti-IL-23 biologic for psoriasis treatment in Europe. On the left side, you can see the market dynamics on the biologics in Germany, where the IL-23 class continues to lead in new patients' market share. Illumetri continues its outstanding performance, with total growth increasing in the half year by around 40%, or 22 million euros compared to the same period last year. The sales contribution of other European countries compared to Germany is over 50%, demonstrating the good traction of the product in other key European markets. We expect the good level of performance to carry on for the rest of 2023. Now let's move to slide 10 to complete the update on our key products. Let's start with Seisara. Despite continued 4% volume growth throughout the first half of 2023, sales dropped by 10% versus the first half of 2022 due to lower growth-to-net pricing. Market share in the antibiotic market remains stable, and we continue to focus our efforts on driving demand and improving the growth-to-net through better payer coverage and increasing access to more commercial lives. In the first half of 2023, glycerin sales grew by around 60%, which is a very good result for a product launch in a market with numerous generic alternatives. The product has seen solid adoption in Germany and Italy, with market shares of around 15% and 18% respectively. In the US, we continue to differentiate Klycity from what is already available on the market, based on efficacy, tolerability, and convenience. Klycity's large-field study has shown it is well-tolerated. A supplemental new drug application based on the FIT3 study is expected to be filed in the second half of the year and a launch anticipated in the U.S. in the second half of 2024. Moving on to Winsora for patients with mild to moderate psoriasis, which we launched in May 2022. We are pleased with the progress, having achieved sales of around 7.7 million in the first half of 2023, with growing shares in Spain and Germany. With that, I will pass to Carl to cover in detail our pipeline section on slide 12.
Thank you, Carlos. This slide shows you the progress of our pipeline. We continue to advance our late-stage pipeline while building an exciting early pipeline. For leprechizumab, we have filed a market authorization application for atopic dermatitis with the EMA and regulatory review is ongoing. We expect approval in Q4 2023. For glycerin, we have completed the clinical study addressing the expansion to large field in the U.S. This phase three multicenter open-label single-arm study evaluated the safety and tolerability of terbanibulim ointment 1% applied to a field of approximately 100 square centimeters on the face or balding scalp in about 100 adult patients with actinic keratosis. The administration of glycerin was well tolerated. Based on those data, we are on track for a submission to FDA in Q3 2023 and would expect the potential approval of the label extension in 2024. For Cesara in China, the phase three clinical study with primary and key secondary endpoints. And we plan to file with the Chinese National Medical Products Administration this quarter. For efinaconazole, we are under regulatory review and target and approval towards the end of 2023. The phase one for our anti-IL-1 rep monoclonal antibody is ongoing. And we aim to start phase one for our IL-2 mutine fusion protein that we develop in collaboration with Simsea later this year. As you can see, we're making good progress with our early and late stage pipeline and are on track to strengthen our leadership position in medical dermatology. Next slide, please. Let's do a quick recap of the key clinical study we have completed thus far for leprechizumab together with our partner, Eli Lilly. Overall, we saw in those studies a very consistent efficacy profile in a clinical development program covering more than 2,000 patients. The safety profile was mild and consistent with prior leprechizumab studies in atopic dermatitis. Advocate 1 and 2 are 52-week randomized double-blind placebo-controlled phase 3 study designed to evaluate leprechaun as monotherapy. In these studies, 80% of leprechaun responders at week 16 maintained improvement in skin clearance and disease severity at week 52. Lasting improvement in each were also observed. Week 52 data supported both every two weeks and once every four weeks maintenance dosing with consistent and durable responses. A tier is a phase three randomized trial to study the efficacy and safety of leprechaun in combination with topical corticosteroids in patients with moderate to severe atopic dermatitis. At week 16, 70% of patients receiving lepricizumab combined with standard of care topical corticosteroids achieved at least 75% improvement in overall disease severity measured by EC75. The advantage study is a phase 3b study in patients not adequately controlled by cyclosporine or for whom cyclosporine is medically not advisable. The primary endpoint at week 16 was met, and we will publish detailed results later this year. As already mentioned, we have started a long-term extension study in Europe called ADLONG to explore long-term benefits of leprechaun up to five years. Furthermore, we are working with our partner, Eli Lilly, on additional clinical studies to maximize the value of leprechaun map as we believe lepricizumab is the best antibody targeting IL-13, the key pathogenic driver of atopic dermatitis. Finally, we continue to be extremely excited about lepricizumab and are confident on the expected approval and launch of lepricizumab towards year-end. We are steadily intensifying our internal efforts to be prepared for a successful commercial launch. With that, I hand over to Mike.
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