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Almirall S.A. — Call Transcript 2025
Jul 25, 2025
Good day, and thank you for standing by. Welcome to the Almirall H 1 twenty twenty five Financial Results and Business Update Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 1 Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pablo Diversson, Head of Investor Relations. Please go ahead. Thank you very much, Heidi, and good morning, everyone. Thank you for joining us today's quarterly earnings update and review of Almirall's first half year financial results of 2025. As always, we are sharing the slides we are using today in the Investors section of our website at almira.com. Please move to Slide number two. Let me remind you that 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 McGillan, Chief Financial Officer Karl Sigabar, Chief Scientific Officer and we also have John Garay, our new CFO, joining us for the first time today. Carlos will start with the business highlights covering the first half of twenty twenty five, followed by an update specifically on biologics as the key growth drivers of our medical dermatology portfolio. Kai will provide you with the R and 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. And we hand over to Carlos Gallardo, our Chairman and CEO. Please move to Slide number five. Thank you, Pablo, and good morning, everyone. Our Mirae's performance in the first half of twenty twenty five reflects the strength and consistency of our sustained long term growth strategy. We are happy to reaffirm our full year 2025 guidance as well as our midterm outlook and peak sales expectations. This confidence is underpinned by the solid momentum across our medical dermatology portfolio, where we continue to expand access to meaningful treatments for patients and physicians. Amel's positions as a European leader in medical dermatology has never been stronger, supported by our commitment to innovation and operational excellence. Airglis continues to deliver strong sales growth during the second quarter of twenty twenty five, driven by a robust uptake in Germany and positive traction from recent country launches. Irrometry continues to display steady year on year growth, which supports our peak sales expectations that we are happy to reconfirm today. Meanwhile, Winthor and Clizirid remain important contributors to our European revenue base, reinforcing the strength of our dermatology portfolio. We have maintained strong engagement in the medical dermatology field this year, participating in major events such as the twenty twenty five annual AAD meeting, the sixteenth Skin Academy in Barcelona, the eleventh World Congress of Melanoma, the twenty first EAGL Congress, and more recently, the twenty twenty five International Congress of Dermatology, ICD in Rome. As a key part of our business development efforts, we actively pursue external innovation opportunities in early and mid stage clinical development, aiming to strengthen our pipeline and broaden our impact in dermatology. We are excited to share that we have recently expanded our collaboration agreement with Simsir to now include new B specific antibodies for immunodermatology diseases. Karl will soon share further insights on this opportunity, along with our remaining pipeline updates. Please move to Slide seven for an update on our biologics portfolio. ILUMETRI continues to demonstrate good momentum within the psoriasis market, solidifying its position within the broader and the IL-twenty three class. The recent rollout of the two hundred milligram formulation has been well received and is contributing nicely to our performance. We also received a positive CHMP opinion regarding inclusion of the new SCALP trial data. This strengthens ILUMETRI's differentiation and reinforces the perceived efficacy of ILUMETRI in treating patients suffering from SCALP psoriasis. In quarter two twenty twenty five, ILUMETRI generated net sales of 58,000,000 marking a 13% increase year over year. This growth reinforces our confidence in the brand's trajectory as it has consistently delivered solid year on year on year growth since its initial European launch back in 2018. We continue to reaffirm our PIXAL's guidance of over 300,000,000. ILUMETRI remains a key growth driver in our portfolio, and we believe it's well positioned to make a lasting impact to patients in the evolving psoriasis treatment landscape. Now that our partner, Sam Pharma, has successfully completed that psoriatic arthritis studies, we are assessing the commercial viability of expanding ILUMETRI into this indication. As a reminder, Almirai holds the rights to develop and commercialize ILUMETRI in Europe, which includes new indications. Please move to the next slide on Eblis highlights. Eblis continues to deliver a strong performance just over one years point since its launch in Germany in December 2023. Cumulative sales have now reached €79,000,000 We view this as the most successful atopic dermatitis launch in recent years, reflecting strong market uptake and effective commercial execution. Overall, the advanced therapies market for atopic dermatitis in The EU5 is experiencing strong growth, expanding at an annual rate of approximately 30% to 40%. Our disciplined approach to launch execution and commercial rollout resulted in a solid market position in Germany and has laid the groundwork for successful expansion across Europe. Within the first year, Evolus captured the second highest dynamic new patient share in the German market, and we are seeing similar trend in our markets. Reimbursement pricing outcomes have been favorable, which we are very pleased about. This reflects the higher net need for advanced treatment options in this disease and the value that national health care systems place on innovations in this space. Brand awareness has also outpaced benchmarks in various markets within one year from the launch. First half year sales quadrupled over year on year and rose 31% quarter on quarter, reaching around CHF 25,500,000.0. While Germany remains the largest contributor of Eplis, early launch countries are beginning to scale following a promising initial uptake. Eplis is now Almirai's second highest selling product available in most major European markets, covering over 90% of our total sales potential. As of today, the growth is commercially reimbursed in 14 European countries. We are expecting to launch in Portugal and Ireland before the end of the year. Our collaboration with Lilly continues to be highly constructive, fostering valuable knowledge exchange that supports ongoing market development. I will now hand over to Karl to provide an update of the progress of the company's pipeline and R and D efforts. Thank you, Carlos, and good morning to everyone on the call from my side. This slide now shows you the status of our pipeline. Let me highlight the progress we made in the last couple of months. Our Phase III study to evaluate the efficacy and safety of tbanibulin applied to a treatment field larger than 25 square centimeters and up to 100 square centimeters in adult patients with actinic keratosis met primary and key secondary endpoints. Detailed results will be presented in an upcoming scientific meeting. We are working on filing with EMA and aim to launch in 2026. Together with our partners, we continue to work in expanding the label for our key products, ILUMETRI and Eplis. Our partner Sun Pharma recently announced the top line results of two Phase III study to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. Both trials met their primary endpoints. We are currently analyzing the results in detail and will keep you updated on next steps. Together with our partner Eli Lilly, we are running a joint clinical development program to make lebrikizumab available to additional patient population. The different programs are well on track, and a detailed overview can be found in the appendix. We have recently received the top line results from the forty eight week interim analysis of the ADLONG study. This study is designed to further explore the long term safety and efficacy of lebrikizumab in patients with moderate to severe atopic dermatitis. The interim results at one year indicate excellent maintenance of efficacy and safety. When these findings are combined with data from the parent study, they support that the majority of patients whose disease was well controlled after a sixteen week induction phase can maintain their response for up to four years with an excellent safety profile. Details of the study will be published at the forthcoming scientific meeting. Recruitment of our AD HOPE studies is progressing very well. ETHOPE I and II are Phase IIIb open label studies to evaluate the effectiveness and safety of a twenty four week lebrikizumab treatment in adult and adolescents with moderate to severe atopic dermatitis. In the ATHOPE II trial, we have started to explore a five hundred milligram Q12 weekly maintenance schedule to explore an extended treatment interval in this phase. We have created an exciting early clinical pipeline addressing novel mechanisms and best in class compounds in high medical need skin diseases. In the coming twelve months, we plan to initiate four proof of concept Phase II clinical studies across a spectrum of different dermatological diseases. Let me highlight some of the progress. For our anti AL1REF monoclonal antibody, we have completed Phase I single and multiple ascending doses in healthy volunteers. Our anti AL1REP monoclonal antibody demonstrated a favorable safety and tolerability profile in healthy volunteers along with a low immunogenicity risk. We have also explored pharmacokinetics and safety in patients suffering from hidradenitis suppurativa with similar results as seen in healthy volunteers. These data support further development of this anti alkaline rep monoclonal antibody, and we plan to start a Phase II study later this year. Together with our partner, Sinsere, we are developing a so called IL-two mutant Fc fusion protein to stimulate regulatory T cells as a novel approach to treat autoimmune skin diseases. We have recently completed Phase I and plan to progress to Phase II within the following month. Furthermore, we have expanded our collaboration with INSERE to jointly discover and develop novel multi specific antibodies for the treatment of various autoimmune skin diseases. This collaboration adds to our bispecific antibody that we have already in preclinical development. Bi- and multispecific antibodies are emerging as the next wave of therapeutic advancement in a broad range of autoimmune diseases. Combining our complementary capabilities and geographic footprint, we believe this collaboration has the potential to generate significantly better therapeutic options for patients suffering from autoimmune skin diseases. In summary, we are progressing very well with both our early and late stage pipeline. With that, I will hand over to Mike for the financial review. Thank you, Karl, for the updates on our R and D pipeline. As Carlos mentioned earlier, we are pleased with how our consistent execution continues to translate into tangible results. In the first half of twenty twenty five, we delivered a solid performance with net sales up nearly 13% year on year, fully aligned with our guidance. Our European dermatology portfolio remains a key growth engine for boosting our overall net sales and reinforcing our path toward leadership in medical dermatology. Gross margin reached 65.5% of sales, supported in part by the outlicensing impact reported in the first quarter. EBITDA for the first half came in at 121,800,000.0 a 17 increase versus the same period last year, driven by the strong top line growth and helped by the Q1 out licensing transaction. SG and A rose 8% to $251,000,000 reflecting our continued investment in the endless rollout. R and D spending increased by about 27% year on year, representing 12.8% of net sales. We had a more evenly distributed quarterly spending in 2025 compared to last year, resulting in a higher R and D investments in the second quarter versus the same period last year. Q2 R and D investment was slightly ahead of external expectations despite being in line with our annual target in relation to sales. We closed the first half with a net debt to EBITDA ratio of 0.4 times. Despite the elementary milestone and dividend payments in the second quarter, cash flow generation remains solid. Our level of leverage continues to be low, providing us with significant flexibility to pursue out licensing opportunities or targeted bolt on acquisitions. These results reinforce our confidence in the full year 2025 guidance and the midterm outlook we shared earlier this year. Let's move on to the details of the sales breakdown on Slide 13. The European dermatology business delivered a great performance, achieving 24% year on year increase for the first half, and I'll dive into the details on the next slide. In general medicine and OTC, European sales were primarily influenced by the recent divestment of Adjudal and the outlicensing of Secusan. Excluding these portfolio moves, the segment remained broadly stable as a delayed allergy season continued, the erosion of epacive, Tessavil, and a lower sales of minor products were offset by a solid contribution for Almax. In terms of outlicensing and royalty income, we expect the full year 2025 to land around $10,000,000 ahead of 2024. These transactions form part of our ongoing strategy to extract maximum value from the portfolio, including the q one transaction I mentioned earlier. Performance declined in The US, and I'll provide further insights on the next slide. Lastly, while general medicine remained broadly stable in the rest of the world, dermatology experience of sight decline. Let's take a closer look at the dermatology business on the next slide. Our European dermatology business segment continues to thrive with ILUMETRI and EBVICE as the primary drivers, but other growth drivers such as, Cliserie and WEN Zor are making progress with their launches in key European markets. Evolus sales reached $45,000,000 in the first half, becoming our second ranked product overall after around eighteen months on the market, driven by uptake in the recently launched markets. This result is in line with our expectation and enhances our confidence in its strong growth trajectory. Losgillarins and ceclipoli maintained similar levels to last year. The U. S. Business recorded a year on year decline, While the Clisteri large field launch continues to generate some positive momentum, these gains have been offset by the continuous pressure on the legacy portfolio. Products such as Tazorac and Axone remain affected by ongoing generic competition, and we had a small stock out of, Cordran tape following a manufacturing change. Additionally, Seysara sales are slightly lower than previous year, mainly due to a decline in the overall oral antibiotic market for acne. The rest of the world saw a dip in dermatology sales year on year due to less minor licensing income than we had last year. Let's now move on to the complete financial statements on slide 15. Let's review the rest of the p and l starting with some elements Carlos mentioned earlier. Gross margin moderated to 65.5% in q two twenty twenty five, following elevated q one levels. This has been temporarily boosted by the out licensing impact in Q1. Looking ahead, we expect to have some continued pressure on margins due to the evolving sales mix and higher royalty levels linked to Elementary's growth. We maintain our full year guidance as outlined in the February call of gross margin percentage equal or slightly lower than 2024. Going forward, we see additional pressure on gross margin percentage due to high royalties and cost of goods of our biologic growth drivers. Our R and D investments have risen to 12.8% of net sales, up from 11.4% in the first half of twenty twenty four, and we expect this to remain steady in the second half while last year ramped up investments in the second half. We anticipate landing in the range of 12.5% of net sales for R and D for the full year. SG and A investments grew by 8% compared to the first half of twenty twenty four. We expect the high single digit growth to continue in 2025 as we focus on launching Evolus in the new markets and supporting existing ones. Going forward, we see much lower increase in the following years as we will have the full infrastructure in place for Biologics already. Financial expenses improved year on year, mainly due to a $6,000,000 positive impact of the valuation of the equity swap, driven by the share price gain year to date. Just a reminder that our effective tax rate continues to be impacted by the fact that U. S. Tax losses cannot be offset against profits generated in Europe, as mentioned in our full year guidance. Please move to the next slide, and we'll take a look at the balance sheet. The main item to highlight on the balance sheet this quarter is the investment in tangible assets in addition to some R and D capitalization related to Evolus Phase IV studies. Key investments also include a milestone upon the successful phase one of our anti I o one wrap monoclonal antibody, which we in licensed from Ichnos back in 2021. The total impact has been outweighed by higher depreciation. Our net debt ratio remains low at 0.4 times, supporting continued flexibility for potential inorganic growth. The increase in net debt primary reflects the Alemetry milestone triggered last year in q four that was paid in q two this year. Let's take a look at the cash flow statement next. We generated $57,600,000 in operating cash flow during the first half of twenty twenty five. Although changes in working capital were more pronounced than in the same period last year, mainly due to higher receivables from the higher sales level. These were largely offset by the increase in profit before tax. In addition to net financial income, which includes the impact of the equity swap, other adjustments reflect some additional pending cash collections. Cash outflows related to investments were lower in the first half of twenty twenty four, primarily because of significant payments made in January 2024 following the AbbVie's launch. The key investment in q two twenty twenty five was an additional 45,000,000 milestone payment linked to ILEMETRI sales that was triggered in the end of twenty twenty four. Remaining investments during the period primarily reflect scheduled milestones under the existing agreements, including the payment to IGNOS following the successful completion of the phase one trial of our anti IL-one rep monoclonal antibody. Cash dividends were higher this year due to a lower level of scrip dividend selected by shareholders. Please proceed to the next slide. As announced earlier in the year, I am stepping down from my role as CFO, and I plan to leave Almirall in mid September. As this is my last earnings call with the company, I want to thank all of the investors, analysts, and others that follow our financial communications for their support and patience in recent years as we reshape the future of the company through significant investments in our new launches and our R and D pipeline. We are now starting to see the initial payoff of these efforts, and I'm happy to hand over to John, who started earlier this week who will take this forward. John brings to the role more than twenty five years of experience in finance and business leadership across the pharmaceutical, medical device, and telecommunication sectors. His deep expertise in specialty medicines and his strong track record in financial leadership make him exceptionally well suited to support Almirall's continued growth as a leading player in medical dermatology. John is here with us today as part of the handover process, so I'll now turn it over to him. Thanks a lot, Mike, for your kind introduction, and good morning, everyone. I feel honored to be here with you all today and join Almirall at this certain point in time, a company with a tremendous legacy that keeps the patient at the center of everything it does. I'm excited for the opportunity to collaborate with Almirall's talented and passionate team, contributed to company mission and sustainable profitable growth to be delivered in upcoming years aligned with 2030 vision. I would like to thank Mike for his support and help during my onboarding. We are working very closely to ensure a smooth transition from day one with a solid focus on business continuity, building up on the woodwork that has already been accomplished. I look forward to meeting many of you in the upcoming months and quarters. And with this, I would like to hand it over back to Carlos for his closing remarks. Thank you, Mike, and thank you, John, and and a very warm welcome. On behalf of the board and the entire Alimera team, I would like to thank Mike McClellan for his leadership and dedication during his tenure as CFO. His contributions have been instrumental in strengthening our financial foundation and supporting our strategic direction. We wish him continued success in his future endeavors. As Mike confirmed, we remain fully on track to meet our 2025 guidance and midterm outlook. Our ambition is to achieve a double digit net sales compounded annual growth rate through 2030 and reach an EBITDA margin of approximately 25% by 2028. As we close the second quarter of twenty twenty five, we are encouraged by the continued momentum driven by Lumetri and Epilisk, which are propelling total sales growth into double digits. Looking ahead, we anticipate further pipeline developments in the next twelve to twenty four months. Over the past decade, we've built a strong foundation in medical dermatology, which continues to offer meaningful opportunities for both growth and margin expansion. What differentiates Almirai in this evolving landscape is a combination of scientific depth, operational excellence, a pipeline with disruptive potential, including several first and best in class assets, and our close long standing relationship with dermatologists and patient communities across Europe. I'm proud to say that over 400,000 patients have been treated with Ardiraj's new dermatological products in 2025. And when I mean new dermatological products, I refer to Eblis, Rheumatrix, Lysuria, Winthora. Our capital allocation strategy remains disciplined and focused. We continue to invest in current and upcoming launches to drive midterm growth, strengthen our pipeline through internal R and D and in licensing, maintain a stable dividend and remain open to targeted business development and licensing opportunities, supported by a solid liquidity position and prudent financial approach. We are excited about the road ahead towards strengthening our leadership in medical dermatology. With that, I will pass the word back to Pablo for Q and A. Thank you very much, Carlos. Heidi, back to you for the Q and A, please. Thank We will take our first question. And the first question comes from the line of Shan Haemer from Jefferies. Please go ahead. Your line is open. Hi there. Thank you for taking my questions. Just two from me. So firstly, what are the current competitive dynamics between Eblis and Nimlivia in Europe? I know Nimlivia only launched earlier this year, but is there anything you can provide on this front? And then secondly, do you find that there's an increasing use of biologics in Europe like Eblis in biologic naive patients? Thank you. Sorry, Shannon. I missed the second part of or the second question. Can you please repeat it? Yeah. Of course. Do you find that there's an increasing use of biologics like Eglis in Europe in biologic naive patients? Sure. Thank you, Shan. I think it's not no surprise that we we're seeing new entrants in atopic dermatitis because it's a tremendously exciting market with that still has tremendous unmet need potential. Yes. And NEMLLUVIO have been recently launched that has indication for porico nodularis and has a IL-thirty one mechanism. We believe if we believe that for AD, the main cytokine remain is IL-thirteen. 13. So and, you know, we could see the role that Nebulio plays in per gonadularis going forward. And in terms of the second question, the use of biologics, yes. I mean, we've seen it. We saw it in the past in the psoriasis market. Whereas we see new entrants, what the new entrants and new classes do is to expand the market and of because there are still a big percentage of eligible patients of moderate to severe disease that are not treated. We are seeing the same dynamics, although at an earlier stage in the atopic dermatitis market. So, yes, we believe that new entrants, what we'll do is expand the market and increase the access of these novel and exciting treatments to patients suffering from atopic dermatitis. Thank you. Thank you. We will take our next question. Your next question comes from the line of Guillaume Sampayya from Kegsaban. Just one so two, if I may. One on Ablys. Is there any factor that we should consider when modeling Ablys sales ramp ups throughout the year or this run rate this quarter on quarter run rate that you're having in the Q1 and Q2 is a good reference? And the second one is a bit on the second half. So if I'm not mistaken, you're assuming a bit more intense OpEx in the second half versus your prior expectations. If you could provide some color on this, it would be great. And on out licensing royalty income expectations, you mentioned a €10,000,000 higher impact versus 2024. If you could provide us some bridge versus your prior expectations. Thank you. Good. Thank you for your questions. Mike, do you wanna take a stab at the questions? Yeah. So, we're seeing good uptake of Evglis. So I think, you know, the the quarter on quarter growth you've seen in the last couple of quarters is probably a fairly good proxy. As we get bigger, that may slow down a little bit, but we're seeing good uptake across this. And we think we're definitely in line to meet or slightly beat the existing Street expectations. So where do we see good good uptake there? The second half, we we we expect, you know, if you look at our our guidance range versus the first half, it'll be fairly consistent. You know, we'll we'll continue to have good sales growth. And and if you look at the EBITDA range versus where we've landed in the first half, it shows that we'll continue to have good good EBITDA growth there too. In terms of what I talked about total, outlicensing and royalties, if you look across the entire business, including, you know, outlicensing we do of of noncore products, things that we haven't launched ourselves that we're we're finding partners. Last year, the that bucket was about 15,000,000 in total. This year, with with the first quarter transaction, we'll end up around 25,000,000 in total. So that's the ten year, the 10,000,000 gap. That also includes some ongoing royalties from older, transactions that we've done and and minor minor outlicensing in in territories like Latin America and and Asia of some assets. So nothing nothing, huge, increase. If you look back into 2023, that bucket was about 20,000,000, so it's fairly consistent. Okay. Thank you. Thank you. We will take our next question. Your next question comes from the line of Niall Alexander from Deutsche Bank. Please go ahead. Your line is open. Hi. How's it going? It's, Neil Alexander from Deutsche Bank. Just two questions, please. On your IL-one monoclonal antibody and hydrogenated supertiva, it'd be helpful just to get your takes on the commercial opportunity there. You have the likes of Benzlek doing well in that space. So just wondering how you could potentially differentiate there once you tick off the regulatory r and d studies. And then on Eglis, just obviously focusing outside of Germany, which seems to be doing well. And just looking into the regions where you have launched, it'd be helpful to get an understanding of how these are tracking, in particular, other EU five regions. Thank you, Nayu, for the question. So I'll give you some some flavor on the I l one, and then I'll and then please, and then I'll pass the word for Karl for further insight into the into the anti I l one. First HS, again, is a big underserved market. The unmet need remains, although there are some treatments approved in HS, the unmet need remains tremendous the sort of suffering by these patients. So very excited to have two programs that are targeting HS, both with a potential to be best in class. The other one is extremely exciting. We have already seen the the results of phase one that confirms, you know, the profile of the product, and now we we will soon enter the POC studies. At least outside Germany, every day, but we're seeing a strong uptake even in countries where we still don't have full access because there is a regional access landscape such as Spain and Italy. We're seeing a very positive uptake of in these countries and already in some cases already being in the double digit in terms of dynamic market share. So, everything we're seeing, very positive and confirming the the potential and the role of IL-thirteen in treating AD patients. Maybe to add on the anti IL-one rep antibody. This antibody is a target, the coreceptor of in total six cytokines of the IL-one cytokine superfamily, IL-one alpha beta, IL-thirty three, and IL-thirty six alpha beta and gamma. Antibody that targets individual cytokines like the IL-one sesser for targeting the IL-thirty six have shown activity in heteradenitis suppurativa. And we believe by having an antibody that can combine those activities will have a chance to see a better efficacy in this very high medical need indication. Thank you very much. Thank you. We will take our next question. Your next question comes from the line of Jamie Escobano from Banco Santander. Please go ahead. Your line is open. Hi. Good morning. So my first question is regarding what you were commenting about Sun Pharma, an opportunity in psoriatic arthritis. Can you elaborate a little bit more on the size of this opportunity? How is this disease compared to the traditional psoriasis? Is there already off label cells of ILUMETRI in this field? When when could you have the indication launched? And second second question is more of, you know, reviewing, like, a smaller products that this quarter were performing well just just to better understand the dynamics. Like, for example, cyclopoly was doing fine. Skilaranz was growing for the first time in several quarters just to to know if there is any specific dynamic there. And also WinSoda, which, least I personally thought it was more of a small product of 20,000,000, maybe 30,000,000, but it's already making a run rate of around 40,000,000. So, what's going on with this product, and what could could we expect? Thank you. Good morning. Hi, Meme. Thanks for the question. So on PSA, happy to see the positive results achieved by our partner Sun in this development. And this, again, adds to the body of evidence of filamentary being an effective treatment to a broader patient population. We are now analyzing the results. We will see what we do going forward, and we will update you as soon as we have a view. Regarding your second question, yes. We are also very happy with the performance of of the a majority of the remaining of our portfolio, very impressed by Winthora. What I suggest maybe, Mike, you can you can comment on cyclopolyskilarence. We have Paolo with us here as well. So maybe, Paolo, you can comment on Winthora. Yeah. So cyclopoly, we're seeing some some small growth there. I think, you know, this is a a product where we are a market leader in in many of the OTC markets across Europe, and it's been a good year so far this year. So it is affected by seasonality of of weather because, you know, it's it's basically a nail fungus remover. And when there's better weather, people tend to wear sandals, they wanna get rid of the nail fungus. So this is a typical annual variance. In terms of scalarins, what we've actually seen is in the main market Germany, one of the competing products has, withdrawn from the market, another one of the DMFs. So so we will see a slight growth this year as we pick up some of that volume, but it's not going to significantly change the the the pattern. But but it's nice for us to have a small growth in that. And maybe, Paolo, you wanna address BINZORA? Hi. Hi, Meh. This is Paolo Sonini, the, commercial officer here in AMIRAI. So, we are very pleased, on the trend of we are having with, with BINZORA. Actually, as a company that want to be a leader in dermatologists, not only about biologics, but it's also offering a note to patients and dermatologists the full spectrum of treatment and, in psoriasis. I mean, we are basically among the the the few companies, actually, the only company offering everything basically from, my disease to the very severe or a complete portfolio, on treating psoriasis. So about WinZora, we are pleased because the sales are catching up in the countries, the most relevant countries where we are operating with such a product. And, and also about the penetration of the market where we are already double digit, high double digit, I would say, in market penetrations, in market share, not only in dynamic but overall. And, and with ZORA showing that through this PAD technology that give us the possibility really to give an options to the patient that is much better than the the available products. I mean, we are really, seeing an increasing penetration of the market, and we will continue like that even in the future. Thank you very much. Thank you. We will take your next question. The next question comes from the line of Francisco Roos from BNP Paribas. Please go ahead. Your line is open. Hi. Good morning. First, I would like to thank Mike for the help during all this year, I wish him the best luck in the next developments. And I also welcome, John. I have two questions. One is a follow-up from Jaime, which is that the €30,000,000 peak sales that you expect in ILUMEDIT does not include this new psoriasis arthritis therapy. And the second one, as always, I asked about the milestones in the coming quarters. So if you could give up a date after the €50,000,000 that we sold in this first half, what is remaining for the second half and what's already known for 2026? Thank you. Yeah. Sure. Hi, Francisco. Yes. The 300,000,000 over 300,000,000 peak sales estimate for ILUMETRI does not include additional indications such as PSA. It's only based on PSO. Mike, do you wanna take the milestone question? Yeah. So so far, you know, I think we're we're still on track to to have total investments this year, you know, between 70 and 80,000,000, absent any large significant new transaction. And and the difference between where we are at the the the half year and the second half means we'll have much less in the second half. It's really just going to be small things based on existing agreements. We may trigger, you know, larger milestones to be paid next year, but I would expect next year to be somewhere in that same ballpark, roughly 80,000,000, of course, absent any new, m and a or in licensing transactions. Okay. Well, thank you. Thank you. We will take our next question. Your next question comes from the line of Jochen Garcia Guerra Gonzalez Pammino from JP Capital. Please go ahead. Your line is open. Yes. Hello. Thank you for taking my question. Just I want to have a bit more insight on Tliceria in The US. It's growing but still very small. So I want to to know if large flow is really having, an effect there. And then despite that, US operations continue to to decline year on year. So what's your, what what are you going to do in the future if this continues? Will you, consider closing, The US operations, or that's not something you're currently considering? Thank you. Hello, Joaquin. Thanks for the question. About The US, we remain on on plan a that we've shared with with you a few times. One is to to stabilize the the the the company with the current portfolio and resume it to the growth trajectory. This year, we're still planning to finish any EBITDA neutral. Once, you know, we maximize the existing portfolio, then we we are looking for bolt on opportunities that that cannot, you know, in the future, that cannot further growth. And then whilst we wait for our pipeline to deliver, as reminder, we have The US rights in all the assets that we have in our portfolio, including the exciting assets that we were talking about just a few minutes ago, such as the anti IL-one. And sorry about Viciri, Kogin. Yes. I think we we are happy with the the launch of the large field. Now we see a majority of prescriptions going to large field versus the small field, and we plan to see the this this this trajectory continued. So not only the molecule is growing based on the the actual sulfur product, but also we're seeing the mix between the large and the small shifting towards favorably towards the natural. And we continue these to us to continue doing this in this trend. Thank you. Thank you. We will take our next question. Your next question comes from the line of Alvaro Lens from Altrauner Equities. Please go ahead. Your line is open. Hi. Thanks for taking my questions. The first one is on this market share. You mentioned you're in the double digits in Germany. I don't know if you have a similar figure or available data for France, in particular, after you launched this quarter? My second question would be in terms of pricing, if you could provide whether pricing in the new launches missing any change and also if you could see potential for price upgrades in the future or if there are any any discussions given the the most favored nation discussions in The United States. I don't know if you see any read across that that could push, in order to drop prices in Europe up in order to compensate for a potential decline in U. S. Prices by big pharma. Thank you. So thank you, Alvaro, for the questions. Please, France, it's it's it's early days to to stop talking about percentages of uptake. What we see is very consistent with what we've seen in in in other markets where we have launched earlier. That that means good feedback, anecdotal, good feedback from physicians, willingness to try. Those that have already experienced with the product, signaling that they are willing to use it more. So quite consistent inputs coming from France compared to to previous, countries where where we have launched base. Pricing pricing, well, as we mentioned a few times, so, we were very happy to see that the health systems in the different countries wanted, new treatments for atopic dermatitis, and then there's a testament of the severe unmet need that remains in this indication. And therefore, we've seen, you know, the the pricing levels that we were expecting, in some cases, maybe slightly better. But also, as we've mentioned a few times also in these calls, we've got reimbursement ahead of in some cases, of the standard times. Right? So overall, in in the market access front, pricing and reimbursement, positive from that side. The future about price upgrades, well, well, in Europe Europe, you know, that's that's have yet to have a see Europe revising pricing upwards. Yes. Now there's an opportunity for Europe given the geopolitical events and the US administration policies to for you to get the act together and start rewarding innovation in a different way. So, let's see what the developments are in this in this front. Thank you. Thank you. There are no further questions. I would like to hand back to Pablo Diverson for closing remarks. Thank you very much, Heidi. As there are no further questions, ladies and gentlemen, this concludes our today's conference call. Thank you for your participation. You may now disconnect. This concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker 1: Good day, and thank you for standing by. Welcome to the Almirall H 1 twenty twenty five Financial Results and Business Update Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. Good day, and thank you for standing by. good day and thank you for standing by Welcome to the Almirall H 1 twenty twenty five Financial Results and Business Update Conference Call. welcome to the almirall h 1 twenty twenty five financial results and business update conference call At this time, all participants are in a listen only mode. at this time all participants are in a listen only mode After the speakers' presentation, there will be a question and answer session. after the speakers' presentation there will be a question and answer session To ask a question during the session, you will need to press 11 on your telephone. to ask a question during the session you will need to press 11 on your telephone You will then hear an automated message advising your hand is raised. To withdraw your question, please press 1 Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pablo Diversson, Head of Investor Relations. Please go ahead. You will then hear an automated message advising your hand is raised. you will then hear an automated message advising your hand is raised To withdraw your question, please press 1 Please be advised that today's conference is being recorded. to withdraw your question please press 1 please be advised that today's conference is being recorded I would now like to hand the conference over to your speaker today, Pablo Diversson, Head of Investor Relations. i would now like to hand the conference over to your speaker today pablo diversson head of investor relations Please go ahead. please go ahead
Speaker 2: Thank you very much, Heidi, and good morning, everyone. Thank you for joining us today's quarterly earnings update and review of Almirall's first half year financial results of 2025. As always, we are sharing the slides we are using today in the Investors section of our website at almira.com. Please move to Slide number two. Let me remind you that 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. Thank you very much, Heidi, and good morning, everyone. thank you very much heidi and good morning everyone Thank you for joining us today's quarterly earnings update and review of Almirall's first half year financial results of 2025. thank you for joining us today's quarterly earnings update and review of almirall's first half year financial results of 2025 As always, we are sharing the slides we are using today in the Investors section of our website at almira.com. as always we are sharing the slides we are using today in the investors section of our website at almira.com Please move to Slide number two. please move to slide number two Let me remind you that 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. let me remind you that 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 McGillan, Chief Financial Officer Karl Sigabar, Chief Scientific Officer and we also have John Garay, our new CFO, joining us for the first time today. Carlos will start with the business highlights covering the first half of twenty twenty five, followed by an update specifically on biologics as the key growth drivers of our medical dermatology portfolio. Kai will provide you with the R and 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. Please move to Slide number three. please move to slide number three Presenting today are Carlos Gallardo, Chairman and Chief Executive Officer Mike McGillan, Chief Financial Officer Karl Sigabar, Chief Scientific Officer and we also have John Garay, our new CFO, joining us for the first time today. presenting today are carlos gallardo chairman and chief executive officer mike mcgillan chief financial officer karl sigabar chief scientific officer and we also have john garay our new cfo joining us for the first time today Carlos will start with the business highlights covering the first half of twenty twenty five, followed by an update specifically on biologics as the key growth drivers of our medical dermatology portfolio. carlos will start with the business highlights covering the first half of twenty twenty five followed by an update specifically on biologics as the key growth drivers of our medical dermatology portfolio Kai will provide you with the R and D status update regarding our pipeline. kai will provide you with the r and 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. and mike will then talk you through the financials before carlos concludes the presentation and we open for questions And we hand over to Carlos Gallardo, our Chairman and CEO. Please move to Slide number five. And we hand over to Carlos Gallardo, our Chairman and CEO. and we hand over to carlos gallardo our chairman and ceo Please move to Slide number five. please move to slide number five
Speaker 3: Thank you, Pablo, and good morning, everyone. Our Mirae's performance in the first half of twenty twenty five reflects the strength and consistency of our sustained long term growth strategy. We are happy to reaffirm our full year 2025 guidance as well as our midterm outlook and peak sales expectations. This confidence is underpinned by the solid momentum across our medical dermatology portfolio, where we continue to expand access to meaningful treatments for patients and physicians. Amel's positions as a European leader in medical dermatology has never been stronger, supported by our commitment to innovation and operational excellence. Thank you, Pablo, and good morning, everyone. thank you pablo and good morning everyone Our Mirae's performance in the first half of twenty twenty five reflects the strength and consistency of our sustained long term growth strategy. our mirae's performance in the first half of twenty twenty five reflects the strength and consistency of our sustained long term growth strategy We are happy to reaffirm our full year 2025 guidance as well as our midterm outlook and peak sales expectations. we are happy to reaffirm our full year 2025 guidance as well as our midterm outlook and peak sales expectations This confidence is underpinned by the solid momentum across our medical dermatology portfolio, where we continue to expand access to meaningful treatments for patients and physicians. this confidence is underpinned by the solid momentum across our medical dermatology portfolio where we continue to expand access to meaningful treatments for patients and physicians Amel's positions as a European leader in medical dermatology has never been stronger, supported by our commitment to innovation and operational excellence. amel's positions as a european leader in medical dermatology has never been stronger supported by our commitment to innovation and operational excellence Airglis continues to deliver strong sales growth during the second quarter of twenty twenty five, driven by a robust uptake in Germany and positive traction from recent country launches. Irrometry continues to display steady year on year growth, which supports our peak sales expectations that we are happy to reconfirm today. Meanwhile, Winthor and Clizirid remain important contributors to our European revenue base, reinforcing the strength of our dermatology portfolio. We have maintained strong engagement in the medical dermatology field this year, participating in major events such as the twenty twenty five annual AAD meeting, the sixteenth Skin Academy in Barcelona, the eleventh World Congress of Melanoma, the twenty first EAGL Congress, and more recently, the twenty twenty five International Congress of Dermatology, ICD in Rome. As a key part of our business development efforts, we actively pursue external innovation opportunities in early and mid stage clinical development, aiming to strengthen our pipeline and broaden our impact in dermatology. Airglis continues to deliver strong sales growth during the second quarter of twenty twenty five, driven by a robust uptake in Germany and positive traction from recent country launches. airglis continues to deliver strong sales growth during the second quarter of twenty twenty five driven by a robust uptake in germany and positive traction from recent country launches Irrometry continues to display steady year on year growth, which supports our peak sales expectations that we are happy to reconfirm today. irrometry continues to display steady year on year growth which supports our peak sales expectations that we are happy to reconfirm today Meanwhile, Winthor and Clizirid remain important contributors to our European revenue base, reinforcing the strength of our dermatology portfolio. meanwhile winthor and clizirid remain important contributors to our european revenue base reinforcing the strength of our dermatology portfolio We have maintained strong engagement in the medical dermatology field this year, participating in major events such as the twenty twenty five annual AAD meeting, the sixteenth Skin Academy in Barcelona, the eleventh World Congress of Melanoma, the twenty first EAGL Congress, and more recently, the twenty twenty five International Congress of Dermatology, ICD in Rome. we have maintained strong engagement in the medical dermatology field this year participating in major events such as the twenty twenty five annual aad meeting the sixteenth skin academy in barcelona the eleventh world congress of melanoma the twenty first eagl congress and more recently the twenty twenty five international congress of dermatology icd in rome As a key part of our business development efforts, we actively pursue external innovation opportunities in early and mid stage clinical development, aiming to strengthen our pipeline and broaden our impact in dermatology. as a key part of our business development efforts we actively pursue external innovation opportunities in early and mid stage clinical development aiming to strengthen our pipeline and broaden our impact in dermatology We are excited to share that we have recently expanded our collaboration agreement with Simsir to now include new B specific antibodies for immunodermatology diseases. Karl will soon share further insights on this opportunity, along with our remaining pipeline updates. Please move to Slide seven for an update on our biologics portfolio. ILUMETRI continues to demonstrate good momentum within the psoriasis market, solidifying its position within the broader and the IL-twenty three class. The recent rollout of the two hundred milligram formulation has been well received and is contributing nicely to our performance. We are excited to share that we have recently expanded our collaboration agreement with Simsir to now include new B specific antibodies for immunodermatology diseases. we are excited to share that we have recently expanded our collaboration agreement with simsir to now include new b specific antibodies for immunodermatology diseases Karl will soon share further insights on this opportunity, along with our remaining pipeline updates. karl will soon share further insights on this opportunity along with our remaining pipeline updates Please move to Slide seven for an update on our biologics portfolio. please move to slide seven for an update on our biologics portfolio ILUMETRI continues to demonstrate good momentum within the psoriasis market, solidifying its position within the broader and the IL-twenty three class. ilumetri continues to demonstrate good momentum within the psoriasis market solidifying its position within the broader and the il-twenty three class The recent rollout of the two hundred milligram formulation has been well received and is contributing nicely to our performance. the recent rollout of the two hundred milligram formulation has been well received and is contributing nicely to our performance We also received a positive CHMP opinion regarding inclusion of the new SCALP trial data. This strengthens ILUMETRI's differentiation and reinforces the perceived efficacy of ILUMETRI in treating patients suffering from SCALP psoriasis. In quarter two twenty twenty five, ILUMETRI generated net sales of 58,000,000 marking a 13% increase year over year. This growth reinforces our confidence in the brand's trajectory as it has consistently delivered solid year on year on year growth since its initial European launch back in 2018. We continue to reaffirm our PIXAL's guidance of over 300,000,000. We also received a positive CHMP opinion regarding inclusion of the new SCALP trial data. we also received a positive chmp opinion regarding inclusion of the new scalp trial data This strengthens ILUMETRI's differentiation and reinforces the perceived efficacy of ILUMETRI in treating patients suffering from SCALP psoriasis. this strengthens ilumetri's differentiation and reinforces the perceived efficacy of ilumetri in treating patients suffering from scalp psoriasis In quarter two twenty twenty five, ILUMETRI generated net sales of 58,000,000 marking a 13% increase year over year. in quarter two twenty twenty five ilumetri generated net sales of 58,000,000 marking a 13% increase year over year This growth reinforces our confidence in the brand's trajectory as it has consistently delivered solid year on year on year growth since its initial European launch back in 2018. this growth reinforces our confidence in the brand's trajectory as it has consistently delivered solid year on year on year growth since its initial european launch back in 2018 We continue to reaffirm our PIXAL's guidance of over 300,000,000. we continue to reaffirm our pixal's guidance of over 300,000,000 ILUMETRI remains a key growth driver in our portfolio, and we believe it's well positioned to make a lasting impact to patients in the evolving psoriasis treatment landscape. Now that our partner, Sam Pharma, has successfully completed that psoriatic arthritis studies, we are assessing the commercial viability of expanding ILUMETRI into this indication. As a reminder, Almirai holds the rights to develop and commercialize ILUMETRI in Europe, which includes new indications. Please move to the next slide on Eblis highlights. Eblis continues to deliver a strong performance just over one years point since its launch in Germany in December 2023. ILUMETRI remains a key growth driver in our portfolio, and we believe it's well positioned to make a lasting impact to patients in the evolving psoriasis treatment landscape. ilumetri remains a key growth driver in our portfolio and we believe it's well positioned to make a lasting impact to patients in the evolving psoriasis treatment landscape Now that our partner, Sam Pharma, has successfully completed that psoriatic arthritis studies, we are assessing the commercial viability of expanding ILUMETRI into this indication. now that our partner sam pharma has successfully completed that psoriatic arthritis studies we are assessing the commercial viability of expanding ilumetri into this indication As a reminder, Almirai holds the rights to develop and commercialize ILUMETRI in Europe, which includes new indications. as a reminder almirai holds the rights to develop and commercialize ilumetri in europe which includes new indications Please move to the next slide on Eblis highlights. please move to the next slide on eblis highlights Eblis continues to deliver a strong performance just over one years point since its launch in Germany in December 2023. eblis continues to deliver a strong performance just over one years point since its launch in germany in december 2023 Cumulative sales have now reached €79,000,000 We view this as the most successful atopic dermatitis launch in recent years, reflecting strong market uptake and effective commercial execution. Overall, the advanced therapies market for atopic dermatitis in The EU5 is experiencing strong growth, expanding at an annual rate of approximately 30% to 40%. Our disciplined approach to launch execution and commercial rollout resulted in a solid market position in Germany and has laid the groundwork for successful expansion across Europe. Within the first year, Evolus captured the second highest dynamic new patient share in the German market, and we are seeing similar trend in our markets. Reimbursement pricing outcomes have been favorable, which we are very pleased about. Cumulative sales have now reached €79,000,000 We view this as the most successful atopic dermatitis launch in recent years, reflecting strong market uptake and effective commercial execution. cumulative sales have now reached €79,000,000 we view this as the most successful atopic dermatitis launch in recent years reflecting strong market uptake and effective commercial execution Overall, the advanced therapies market for atopic dermatitis in The EU5 is experiencing strong growth, expanding at an annual rate of approximately 30% to 40%. overall the advanced therapies market for atopic dermatitis in the eu5 is experiencing strong growth expanding at an annual rate of approximately 30% to 40% Our disciplined approach to launch execution and commercial rollout resulted in a solid market position in Germany and has laid the groundwork for successful expansion across Europe. our disciplined approach to launch execution and commercial rollout resulted in a solid market position in germany and has laid the groundwork for successful expansion across europe Within the first year, Evolus captured the second highest dynamic new patient share in the German market, and we are seeing similar trend in our markets. within the first year evolus captured the second highest dynamic new patient share in the german market and we are seeing similar trend in our markets Reimbursement pricing outcomes have been favorable, which we are very pleased about. reimbursement pricing outcomes have been favorable which we are very pleased about This reflects the higher net need for advanced treatment options in this disease and the value that national health care systems place on innovations in this space. Brand awareness has also outpaced benchmarks in various markets within one year from the launch. First half year sales quadrupled over year on year and rose 31% quarter on quarter, reaching around CHF 25,500,000.0. While Germany remains the largest contributor of Eplis, early launch countries are beginning to scale following a promising initial uptake. Eplis is now Almirai's second highest selling product available in most major European markets, covering over 90% of our total sales potential. This reflects the higher net need for advanced treatment options in this disease and the value that national health care systems place on innovations in this space. this reflects the higher net need for advanced treatment options in this disease and the value that national health care systems place on innovations in this space Brand awareness has also outpaced benchmarks in various markets within one year from the launch. brand awareness has also outpaced benchmarks in various markets within one year from the launch First half year sales quadrupled over year on year and rose 31% quarter on quarter, reaching around CHF 25,500,000.0. first half year sales quadrupled over year on year and rose 31% quarter on quarter reaching around chf 25,500,000.0 While Germany remains the largest contributor of Eplis, early launch countries are beginning to scale following a promising initial uptake. while germany remains the largest contributor of eplis early launch countries are beginning to scale following a promising initial uptake Eplis is now Almirai's second highest selling product available in most major European markets, covering over 90% of our total sales potential. eplis is now almirai's second highest selling product available in most major european markets covering over 90% of our total sales potential As of today, the growth is commercially reimbursed in 14 European countries. We are expecting to launch in Portugal and Ireland before the end of the year. Our collaboration with Lilly continues to be highly constructive, fostering valuable knowledge exchange that supports ongoing market development. I will now hand over to Karl to provide an update of the progress of the company's pipeline and R and D efforts. As of today, the growth is commercially reimbursed in 14 European countries. as of today the growth is commercially reimbursed in 14 european countries We are expecting to launch in Portugal and Ireland before the end of the year. we are expecting to launch in portugal and ireland before the end of the year Our collaboration with Lilly continues to be highly constructive, fostering valuable knowledge exchange that supports ongoing market development. our collaboration with lilly continues to be highly constructive fostering valuable knowledge exchange that supports ongoing market development I will now hand over to Karl to provide an update of the progress of the company's pipeline and R and D efforts. i will now hand over to karl to provide an update of the progress of the company's pipeline and r and d efforts
Speaker 4: Thank you, Carlos, and good morning to everyone on the call from my side. This slide now shows you the status of our pipeline. Let me highlight the progress we made in the last couple of months. Our Phase III study to evaluate the efficacy and safety of tbanibulin applied to a treatment field larger than 25 square centimeters and up to 100 square centimeters in adult patients with actinic keratosis met primary and key secondary endpoints. Detailed results will be presented in an upcoming scientific meeting. Thank you, Carlos, and good morning to everyone on the call from my side. thank you carlos and good morning to everyone on the call from my side This slide now shows you the status of our pipeline. this slide now shows you the status of our pipeline Let me highlight the progress we made in the last couple of months. let me highlight the progress we made in the last couple of months Our Phase III study to evaluate the efficacy and safety of tbanibulin applied to a treatment field larger than 25 square centimeters and up to 100 square centimeters in adult patients with actinic keratosis met primary and key secondary endpoints. our phase iii study to evaluate the efficacy and safety of tbanibulin applied to a treatment field larger than 25 square centimeters and up to 100 square centimeters in adult patients with actinic keratosis met primary and key secondary endpoints Detailed results will be presented in an upcoming scientific meeting. detailed results will be presented in an upcoming scientific meeting We are working on filing with EMA and aim to launch in 2026. Together with our partners, we continue to work in expanding the label for our key products, ILUMETRI and Eplis. Our partner Sun Pharma recently announced the top line results of two Phase III study to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. Both trials met their primary endpoints. We are currently analyzing the results in detail and will keep you updated on next steps. We are working on filing with EMA and aim to launch in 2026. we are working on filing with ema and aim to launch in 2026 Together with our partners, we continue to work in expanding the label for our key products, ILUMETRI and Eplis. together with our partners we continue to work in expanding the label for our key products ilumetri and eplis Our partner Sun Pharma recently announced the top line results of two Phase III study to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. our partner sun pharma recently announced the top line results of two phase iii study to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis Both trials met their primary endpoints. both trials met their primary endpoints We are currently analyzing the results in detail and will keep you updated on next steps. we are currently analyzing the results in detail and will keep you updated on next steps Together with our partner Eli Lilly, we are running a joint clinical development program to make lebrikizumab available to additional patient population. The different programs are well on track, and a detailed overview can be found in the appendix. We have recently received the top line results from the forty eight week interim analysis of the ADLONG study. This study is designed to further explore the long term safety and efficacy of lebrikizumab in patients with moderate to severe atopic dermatitis. The interim results at one year indicate excellent maintenance of efficacy and safety. Together with our partner Eli Lilly, we are running a joint clinical development program to make lebrikizumab available to additional patient population. together with our partner eli lilly we are running a joint clinical development program to make lebrikizumab available to additional patient population The different programs are well on track, and a detailed overview can be found in the appendix. the different programs are well on track and a detailed overview can be found in the appendix We have recently received the top line results from the forty eight week interim analysis of the ADLONG study. we have recently received the top line results from the forty eight week interim analysis of the adlong study This study is designed to further explore the long term safety and efficacy of lebrikizumab in patients with moderate to severe atopic dermatitis. this study is designed to further explore the long term safety and efficacy of lebrikizumab in patients with moderate to severe atopic dermatitis The interim results at one year indicate excellent maintenance of efficacy and safety. the interim results at one year indicate excellent maintenance of efficacy and safety When these findings are combined with data from the parent study, they support that the majority of patients whose disease was well controlled after a sixteen week induction phase can maintain their response for up to four years with an excellent safety profile. Details of the study will be published at the forthcoming scientific meeting. Recruitment of our AD HOPE studies is progressing very well. ETHOPE I and II are Phase IIIb open label studies to evaluate the effectiveness and safety of a twenty four week lebrikizumab treatment in adult and adolescents with moderate to severe atopic dermatitis. In the ATHOPE II trial, we have started to explore a five hundred milligram Q12 weekly maintenance schedule to explore an extended treatment interval in this phase. When these findings are combined with data from the parent study, they support that the majority of patients whose disease was well controlled after a sixteen week induction phase can maintain their response for up to four years with an excellent safety profile. when these findings are combined with data from the parent study they support that the majority of patients whose disease was well controlled after a sixteen week induction phase can maintain their response for up to four years with an excellent safety profile Details of the study will be published at the forthcoming scientific meeting. details of the study will be published at the forthcoming scientific meeting Recruitment of our AD HOPE studies is progressing very well. recruitment of our ad hope studies is progressing very well ETHOPE I and II are Phase IIIb open label studies to evaluate the effectiveness and safety of a twenty four week lebrikizumab treatment in adult and adolescents with moderate to severe atopic dermatitis. ethope i and ii are phase iiib open label studies to evaluate the effectiveness and safety of a twenty four week lebrikizumab treatment in adult and adolescents with moderate to severe atopic dermatitis In the ATHOPE II trial, we have started to explore a five hundred milligram Q12 weekly maintenance schedule to explore an extended treatment interval in this phase. in the athope ii trial we have started to explore a five hundred milligram q12 weekly maintenance schedule to explore an extended treatment interval in this phase We have created an exciting early clinical pipeline addressing novel mechanisms and best in class compounds in high medical need skin diseases. In the coming twelve months, we plan to initiate four proof of concept Phase II clinical studies across a spectrum of different dermatological diseases. Let me highlight some of the progress. For our anti AL1REF monoclonal antibody, we have completed Phase I single and multiple ascending doses in healthy volunteers. Our anti AL1REP monoclonal antibody demonstrated a favorable safety and tolerability profile in healthy volunteers along with a low immunogenicity risk. We have created an exciting early clinical pipeline addressing novel mechanisms and best in class compounds in high medical need skin diseases. we have created an exciting early clinical pipeline addressing novel mechanisms and best in class compounds in high medical need skin diseases In the coming twelve months, we plan to initiate four proof of concept Phase II clinical studies across a spectrum of different dermatological diseases. in the coming twelve months we plan to initiate four proof of concept phase ii clinical studies across a spectrum of different dermatological diseases Let me highlight some of the progress. let me highlight some of the progress For our anti AL1REF monoclonal antibody, we have completed Phase I single and multiple ascending doses in healthy volunteers. for our anti al1ref monoclonal antibody we have completed phase i single and multiple ascending doses in healthy volunteers Our anti AL1REP monoclonal antibody demonstrated a favorable safety and tolerability profile in healthy volunteers along with a low immunogenicity risk. our anti al1rep monoclonal antibody demonstrated a favorable safety and tolerability profile in healthy volunteers along with a low immunogenicity risk We have also explored pharmacokinetics and safety in patients suffering from hidradenitis suppurativa with similar results as seen in healthy volunteers. These data support further development of this anti alkaline rep monoclonal antibody, and we plan to start a Phase II study later this year. Together with our partner, Sinsere, we are developing a so called IL-two mutant Fc fusion protein to stimulate regulatory T cells as a novel approach to treat autoimmune skin diseases. We have recently completed Phase I and plan to progress to Phase II within the following month. Furthermore, we have expanded our collaboration with INSERE to jointly discover and develop novel multi specific antibodies for the treatment of various autoimmune skin diseases. We have also explored pharmacokinetics and safety in patients suffering from hidradenitis suppurativa with similar results as seen in healthy volunteers. we have also explored pharmacokinetics and safety in patients suffering from hidradenitis suppurativa with similar results as seen in healthy volunteers These data support further development of this anti alkaline rep monoclonal antibody, and we plan to start a Phase II study later this year. these data support further development of this anti alkaline rep monoclonal antibody and we plan to start a phase ii study later this year Together with our partner, Sinsere, we are developing a so called IL-two mutant Fc fusion protein to stimulate regulatory T cells as a novel approach to treat autoimmune skin diseases. together with our partner sinsere we are developing a so called il-two mutant fc fusion protein to stimulate regulatory t cells as a novel approach to treat autoimmune skin diseases We have recently completed Phase I and plan to progress to Phase II within the following month. we have recently completed phase i and plan to progress to phase ii within the following month Furthermore, we have expanded our collaboration with INSERE to jointly discover and develop novel multi specific antibodies for the treatment of various autoimmune skin diseases. furthermore we have expanded our collaboration with insere to jointly discover and develop novel multi specific antibodies for the treatment of various autoimmune skin diseases This collaboration adds to our bispecific antibody that we have already in preclinical development. Bi- and multispecific antibodies are emerging as the next wave of therapeutic advancement in a broad range of autoimmune diseases. Combining our complementary capabilities and geographic footprint, we believe this collaboration has the potential to generate significantly better therapeutic options for patients suffering from autoimmune skin diseases. In summary, we are progressing very well with both our early and late stage pipeline. With that, I will hand over to Mike for the financial review. This collaboration adds to our bispecific antibody that we have already in preclinical development. this collaboration adds to our bispecific antibody that we have already in preclinical development Bi- and multispecific antibodies are emerging as the next wave of therapeutic advancement in a broad range of autoimmune diseases. bi- and multispecific antibodies are emerging as the next wave of therapeutic advancement in a broad range of autoimmune diseases Combining our complementary capabilities and geographic footprint, we believe this collaboration has the potential to generate significantly better therapeutic options for patients suffering from autoimmune skin diseases. combining our complementary capabilities and geographic footprint we believe this collaboration has the potential to generate significantly better therapeutic options for patients suffering from autoimmune skin diseases In summary, we are progressing very well with both our early and late stage pipeline. in summary we are progressing very well with both our early and late stage pipeline With that, I will hand over to Mike for the financial review. with that i will hand over to mike for the financial review
Speaker 5: Thank you, Karl, for the updates on our R and D pipeline. As Carlos mentioned earlier, we are pleased with how our consistent execution continues to translate into tangible results. In the first half of twenty twenty five, we delivered a solid performance with net sales up nearly 13% year on year, fully aligned with our guidance. Our European dermatology portfolio remains a key growth engine for boosting our overall net sales and reinforcing our path toward leadership in medical dermatology. Gross margin reached 65.5% of sales, supported in part by the outlicensing impact reported in the first quarter. Thank you, Karl, for the updates on our R and D pipeline. thank you karl for the updates on our r and d pipeline As Carlos mentioned earlier, we are pleased with how our consistent execution continues to translate into tangible results. as carlos mentioned earlier we are pleased with how our consistent execution continues to translate into tangible results In the first half of twenty twenty five, we delivered a solid performance with net sales up nearly 13% year on year, fully aligned with our guidance. in the first half of twenty twenty five we delivered a solid performance with net sales up nearly 13% year on year fully aligned with our guidance Our European dermatology portfolio remains a key growth engine for boosting our overall net sales and reinforcing our path toward leadership in medical dermatology. our european dermatology portfolio remains a key growth engine for boosting our overall net sales and reinforcing our path toward leadership in medical dermatology Gross margin reached 65.5% of sales, supported in part by the outlicensing impact reported in the first quarter. gross margin reached 65.5% of sales supported in part by the outlicensing impact reported in the first quarter EBITDA for the first half came in at 121,800,000.0 a 17 increase versus the same period last year, driven by the strong top line growth and helped by the Q1 out licensing transaction. SG and A rose 8% to $251,000,000 reflecting our continued investment in the endless rollout. R and D spending increased by about 27% year on year, representing 12.8% of net sales. We had a more evenly distributed quarterly spending in 2025 compared to last year, resulting in a higher R and D investments in the second quarter versus the same period last year. Q2 R and D investment was slightly ahead of external expectations despite being in line with our annual target in relation to sales. EBITDA for the first half came in at 121,800,000.0 a 17 increase versus the same period last year, driven by the strong top line growth and helped by the Q1 out licensing transaction. ebitda for the first half came in at 121,800,000.0 a 17 increase versus the same period last year driven by the strong top line growth and helped by the q1 out licensing transaction SG and A rose 8% to $251,000,000 reflecting our continued investment in the endless rollout. sg and a rose 8% to $251,000,000 reflecting our continued investment in the endless rollout R and D spending increased by about 27% year on year, representing 12.8% of net sales. r and d spending increased by about 27% year on year representing 12.8% of net sales We had a more evenly distributed quarterly spending in 2025 compared to last year, resulting in a higher R and D investments in the second quarter versus the same period last year. we had a more evenly distributed quarterly spending in 2025 compared to last year resulting in a higher r and d investments in the second quarter versus the same period last year Q2 R and D investment was slightly ahead of external expectations despite being in line with our annual target in relation to sales. q2 r and d investment was slightly ahead of external expectations despite being in line with our annual target in relation to sales We closed the first half with a net debt to EBITDA ratio of 0.4 times. Despite the elementary milestone and dividend payments in the second quarter, cash flow generation remains solid. Our level of leverage continues to be low, providing us with significant flexibility to pursue out licensing opportunities or targeted bolt on acquisitions. These results reinforce our confidence in the full year 2025 guidance and the midterm outlook we shared earlier this year. Let's move on to the details of the sales breakdown on Slide 13. We closed the first half with a net debt to EBITDA ratio of 0.4 times. we closed the first half with a net debt to ebitda ratio of 0.4 times Despite the elementary milestone and dividend payments in the second quarter, cash flow generation remains solid. despite the elementary milestone and dividend payments in the second quarter cash flow generation remains solid Our level of leverage continues to be low, providing us with significant flexibility to pursue out licensing opportunities or targeted bolt on acquisitions. our level of leverage continues to be low providing us with significant flexibility to pursue out licensing opportunities or targeted bolt on acquisitions These results reinforce our confidence in the full year 2025 guidance and the midterm outlook we shared earlier this year. these results reinforce our confidence in the full year 2025 guidance and the midterm outlook we shared earlier this year Let's move on to the details of the sales breakdown on Slide 13. let's move on to the details of the sales breakdown on slide 13 The European dermatology business delivered a great performance, achieving 24% year on year increase for the first half, and I'll dive into the details on the next slide. In general medicine and OTC, European sales were primarily influenced by the recent divestment of Adjudal and the outlicensing of Secusan. Excluding these portfolio moves, the segment remained broadly stable as a delayed allergy season continued, the erosion of epacive, Tessavil, and a lower sales of minor products were offset by a solid contribution for Almax. In terms of outlicensing and royalty income, we expect the full year 2025 to land around $10,000,000 ahead of 2024. These transactions form part of our ongoing strategy to extract maximum value from the portfolio, including the q one transaction I mentioned earlier. The European dermatology business delivered a great performance, achieving 24% year on year increase for the first half, and I'll dive into the details on the next slide. the european dermatology business delivered a great performance achieving 24% year on year increase for the first half and i'll dive into the details on the next slide In general medicine and OTC, European sales were primarily influenced by the recent divestment of Adjudal and the outlicensing of Secusan. in general medicine and otc european sales were primarily influenced by the recent divestment of adjudal and the outlicensing of secusan Excluding these portfolio moves, the segment remained broadly stable as a delayed allergy season continued, the erosion of epacive, Tessavil, and a lower sales of minor products were offset by a solid contribution for Almax. excluding these portfolio moves the segment remained broadly stable as a delayed allergy season continued the erosion of epacive tessavil and a lower sales of minor products were offset by a solid contribution for almax In terms of outlicensing and royalty income, we expect the full year 2025 to land around $10,000,000 ahead of 2024. in terms of outlicensing and royalty income we expect the full year 2025 to land around $10,000,000 ahead of 2024 These transactions form part of our ongoing strategy to extract maximum value from the portfolio, including the q one transaction I mentioned earlier. these transactions form part of our ongoing strategy to extract maximum value from the portfolio including the q one transaction i mentioned earlier Performance declined in The US, and I'll provide further insights on the next slide. Lastly, while general medicine remained broadly stable in the rest of the world, dermatology experience of sight decline. Let's take a closer look at the dermatology business on the next slide. Our European dermatology business segment continues to thrive with ILUMETRI and EBVICE as the primary drivers, but other growth drivers such as, Cliserie and WEN Zor are making progress with their launches in key European markets. Evolus sales reached $45,000,000 in the first half, becoming our second ranked product overall after around eighteen months on the market, driven by uptake in the recently launched markets. Performance declined in The US, and I'll provide further insights on the next slide. performance declined in the us and i'll provide further insights on the next slide Lastly, while general medicine remained broadly stable in the rest of the world, dermatology experience of sight decline. lastly while general medicine remained broadly stable in the rest of the world dermatology experience of sight decline Let's take a closer look at the dermatology business on the next slide. let's take a closer look at the dermatology business on the next slide Our European dermatology business segment continues to thrive with ILUMETRI and EBVICE as the primary drivers, but other growth drivers such as, Cliserie and WEN Zor are making progress with their launches in key European markets. our european dermatology business segment continues to thrive with ilumetri and ebvice as the primary drivers but other growth drivers such as cliserie and wen zor are making progress with their launches in key european markets Evolus sales reached $45,000,000 in the first half, becoming our second ranked product overall after around eighteen months on the market, driven by uptake in the recently launched markets. evolus sales reached $45,000,000 in the first half becoming our second ranked product overall after around eighteen months on the market driven by uptake in the recently launched markets This result is in line with our expectation and enhances our confidence in its strong growth trajectory. Losgillarins and ceclipoli maintained similar levels to last year. The U. S. Business recorded a year on year decline, While the Clisteri large field launch continues to generate some positive momentum, these gains have been offset by the continuous pressure on the legacy portfolio. This result is in line with our expectation and enhances our confidence in its strong growth trajectory. this result is in line with our expectation and enhances our confidence in its strong growth trajectory Losgillarins and ceclipoli maintained similar levels to last year. losgillarins and ceclipoli maintained similar levels to last year The U. the u S. s Business recorded a year on year decline, While the Clisteri large field launch continues to generate some positive momentum, these gains have been offset by the continuous pressure on the legacy portfolio. business recorded a year on year decline while the clisteri large field launch continues to generate some positive momentum these gains have been offset by the continuous pressure on the legacy portfolio Products such as Tazorac and Axone remain affected by ongoing generic competition, and we had a small stock out of, Cordran tape following a manufacturing change. Additionally, Seysara sales are slightly lower than previous year, mainly due to a decline in the overall oral antibiotic market for acne. The rest of the world saw a dip in dermatology sales year on year due to less minor licensing income than we had last year. Let's now move on to the complete financial statements on slide 15. Let's review the rest of the p and l starting with some elements Carlos mentioned earlier. Products such as Tazorac and Axone remain affected by ongoing generic competition, and we had a small stock out of, Cordran tape following a manufacturing change. products such as tazorac and axone remain affected by ongoing generic competition and we had a small stock out of cordran tape following a manufacturing change Additionally, Seysara sales are slightly lower than previous year, mainly due to a decline in the overall oral antibiotic market for acne. additionally seysara sales are slightly lower than previous year mainly due to a decline in the overall oral antibiotic market for acne The rest of the world saw a dip in dermatology sales year on year due to less minor licensing income than we had last year. the rest of the world saw a dip in dermatology sales year on year due to less minor licensing income than we had last year Let's now move on to the complete financial statements on slide 15. let's now move on to the complete financial statements on slide 15 Let's review the rest of the p and l starting with some elements Carlos mentioned earlier. let's review the rest of the p and l starting with some elements carlos mentioned earlier Gross margin moderated to 65.5% in q two twenty twenty five, following elevated q one levels. This has been temporarily boosted by the out licensing impact in Q1. Looking ahead, we expect to have some continued pressure on margins due to the evolving sales mix and higher royalty levels linked to Elementary's growth. We maintain our full year guidance as outlined in the February call of gross margin percentage equal or slightly lower than 2024. Going forward, we see additional pressure on gross margin percentage due to high royalties and cost of goods of our biologic growth drivers. Gross margin moderated to 65.5% in q two twenty twenty five, following elevated q one levels. gross margin moderated to 65.5% in q two twenty twenty five following elevated q one levels This has been temporarily boosted by the out licensing impact in Q1. this has been temporarily boosted by the out licensing impact in q1 Looking ahead, we expect to have some continued pressure on margins due to the evolving sales mix and higher royalty levels linked to Elementary's growth. looking ahead we expect to have some continued pressure on margins due to the evolving sales mix and higher royalty levels linked to elementary's growth We maintain our full year guidance as outlined in the February call of gross margin percentage equal or slightly lower than 2024. we maintain our full year guidance as outlined in the february call of gross margin percentage equal or slightly lower than 2024 Going forward, we see additional pressure on gross margin percentage due to high royalties and cost of goods of our biologic growth drivers. going forward we see additional pressure on gross margin percentage due to high royalties and cost of goods of our biologic growth drivers Our R and D investments have risen to 12.8% of net sales, up from 11.4% in the first half of twenty twenty four, and we expect this to remain steady in the second half while last year ramped up investments in the second half. We anticipate landing in the range of 12.5% of net sales for R and D for the full year. SG and A investments grew by 8% compared to the first half of twenty twenty four. We expect the high single digit growth to continue in 2025 as we focus on launching Evolus in the new markets and supporting existing ones. Going forward, we see much lower increase in the following years as we will have the full infrastructure in place for Biologics already. Our R and D investments have risen to 12.8% of net sales, up from 11.4% in the first half of twenty twenty four, and we expect this to remain steady in the second half while last year ramped up investments in the second half. our r and d investments have risen to 12.8% of net sales up from 11.4% in the first half of twenty twenty four and we expect this to remain steady in the second half while last year ramped up investments in the second half We anticipate landing in the range of 12.5% of net sales for R and D for the full year. we anticipate landing in the range of 12.5% of net sales for r and d for the full year SG and A investments grew by 8% compared to the first half of twenty twenty four. sg and a investments grew by 8% compared to the first half of twenty twenty four We expect the high single digit growth to continue in 2025 as we focus on launching Evolus in the new markets and supporting existing ones. we expect the high single digit growth to continue in 2025 as we focus on launching evolus in the new markets and supporting existing ones Going forward, we see much lower increase in the following years as we will have the full infrastructure in place for Biologics already. going forward we see much lower increase in the following years as we will have the full infrastructure in place for biologics already Financial expenses improved year on year, mainly due to a $6,000,000 positive impact of the valuation of the equity swap, driven by the share price gain year to date. Just a reminder that our effective tax rate continues to be impacted by the fact that U. S. Tax losses cannot be offset against profits generated in Europe, as mentioned in our full year guidance. Please move to the next slide, and we'll take a look at the balance sheet. Financial expenses improved year on year, mainly due to a $6,000,000 positive impact of the valuation of the equity swap, driven by the share price gain year to date. financial expenses improved year on year mainly due to a $6,000,000 positive impact of the valuation of the equity swap driven by the share price gain year to date Just a reminder that our effective tax rate continues to be impacted by the fact that U. just a reminder that our effective tax rate continues to be impacted by the fact that u S. s Tax losses cannot be offset against profits generated in Europe, as mentioned in our full year guidance. tax losses cannot be offset against profits generated in europe as mentioned in our full year guidance Please move to the next slide, and we'll take a look at the balance sheet. please move to the next slide and we'll take a look at the balance sheet The main item to highlight on the balance sheet this quarter is the investment in tangible assets in addition to some R and D capitalization related to Evolus Phase IV studies. Key investments also include a milestone upon the successful phase one of our anti I o one wrap monoclonal antibody, which we in licensed from Ichnos back in 2021. The total impact has been outweighed by higher depreciation. Our net debt ratio remains low at 0.4 times, supporting continued flexibility for potential inorganic growth. The increase in net debt primary reflects the Alemetry milestone triggered last year in q four that was paid in q two this year. The main item to highlight on the balance sheet this quarter is the investment in tangible assets in addition to some R and D capitalization related to Evolus Phase IV studies. the main item to highlight on the balance sheet this quarter is the investment in tangible assets in addition to some r and d capitalization related to evolus phase iv studies Key investments also include a milestone upon the successful phase one of our anti I o one wrap monoclonal antibody, which we in licensed from Ichnos back in 2021. key investments also include a milestone upon the successful phase one of our anti i o one wrap monoclonal antibody which we in licensed from ichnos back in 2021 The total impact has been outweighed by higher depreciation. the total impact has been outweighed by higher depreciation Our net debt ratio remains low at 0.4 times, supporting continued flexibility for potential inorganic growth. our net debt ratio remains low at 0.4 times supporting continued flexibility for potential inorganic growth The increase in net debt primary reflects the Alemetry milestone triggered last year in q four that was paid in q two this year. the increase in net debt primary reflects the alemetry milestone triggered last year in q four that was paid in q two this year Let's take a look at the cash flow statement next. We generated $57,600,000 in operating cash flow during the first half of twenty twenty five. Although changes in working capital were more pronounced than in the same period last year, mainly due to higher receivables from the higher sales level. These were largely offset by the increase in profit before tax. In addition to net financial income, which includes the impact of the equity swap, other adjustments reflect some additional pending cash collections. Let's take a look at the cash flow statement next. let's take a look at the cash flow statement next We generated $57,600,000 in operating cash flow during the first half of twenty twenty five. we generated $57,600,000 in operating cash flow during the first half of twenty twenty five Although changes in working capital were more pronounced than in the same period last year, mainly due to higher receivables from the higher sales level. although changes in working capital were more pronounced than in the same period last year mainly due to higher receivables from the higher sales level These were largely offset by the increase in profit before tax. these were largely offset by the increase in profit before tax In addition to net financial income, which includes the impact of the equity swap, other adjustments reflect some additional pending cash collections. in addition to net financial income which includes the impact of the equity swap other adjustments reflect some additional pending cash collections Cash outflows related to investments were lower in the first half of twenty twenty four, primarily because of significant payments made in January 2024 following the AbbVie's launch. The key investment in q two twenty twenty five was an additional 45,000,000 milestone payment linked to ILEMETRI sales that was triggered in the end of twenty twenty four. Remaining investments during the period primarily reflect scheduled milestones under the existing agreements, including the payment to IGNOS following the successful completion of the phase one trial of our anti IL-one rep monoclonal antibody. Cash dividends were higher this year due to a lower level of scrip dividend selected by shareholders. Please proceed to the next slide. Cash outflows related to investments were lower in the first half of twenty twenty four, primarily because of significant payments made in January 2024 following the AbbVie's launch. cash outflows related to investments were lower in the first half of twenty twenty four primarily because of significant payments made in january 2024 following the abbvie's launch The key investment in q two twenty twenty five was an additional 45,000,000 milestone payment linked to ILEMETRI sales that was triggered in the end of twenty twenty four. the key investment in q two twenty twenty five was an additional 45,000,000 milestone payment linked to ilemetri sales that was triggered in the end of twenty twenty four Remaining investments during the period primarily reflect scheduled milestones under the existing agreements, including the payment to IGNOS following the successful completion of the phase one trial of our anti IL-one rep monoclonal antibody. remaining investments during the period primarily reflect scheduled milestones under the existing agreements including the payment to ignos following the successful completion of the phase one trial of our anti il-one rep monoclonal antibody Cash dividends were higher this year due to a lower level of scrip dividend selected by shareholders. cash dividends were higher this year due to a lower level of scrip dividend selected by shareholders Please proceed to the next slide. please proceed to the next slide As announced earlier in the year, I am stepping down from my role as CFO, and I plan to leave Almirall in mid September. As this is my last earnings call with the company, I want to thank all of the investors, analysts, and others that follow our financial communications for their support and patience in recent years as we reshape the future of the company through significant investments in our new launches and our R and D pipeline. We are now starting to see the initial payoff of these efforts, and I'm happy to hand over to John, who started earlier this week who will take this forward. John brings to the role more than twenty five years of experience in finance and business leadership across the pharmaceutical, medical device, and telecommunication sectors. His deep expertise in specialty medicines and his strong track record in financial leadership make him exceptionally well suited to support Almirall's continued growth as a leading player in medical dermatology. As announced earlier in the year, I am stepping down from my role as CFO, and I plan to leave Almirall in mid September. as announced earlier in the year i am stepping down from my role as cfo and i plan to leave almirall in mid september As this is my last earnings call with the company, I want to thank all of the investors, analysts, and others that follow our financial communications for their support and patience in recent years as we reshape the future of the company through significant investments in our new launches and our R and D pipeline. as this is my last earnings call with the company i want to thank all of the investors analysts and others that follow our financial communications for their support and patience in recent years as we reshape the future of the company through significant investments in our new launches and our r and d pipeline We are now starting to see the initial payoff of these efforts, and I'm happy to hand over to John, who started earlier this week who will take this forward. we are now starting to see the initial payoff of these efforts and i'm happy to hand over to john who started earlier this week who will take this forward John brings to the role more than twenty five years of experience in finance and business leadership across the pharmaceutical, medical device, and telecommunication sectors. john brings to the role more than twenty five years of experience in finance and business leadership across the pharmaceutical medical device and telecommunication sectors His deep expertise in specialty medicines and his strong track record in financial leadership make him exceptionally well suited to support Almirall's continued growth as a leading player in medical dermatology. his deep expertise in specialty medicines and his strong track record in financial leadership make him exceptionally well suited to support almirall's continued growth as a leading player in medical dermatology John is here with us today as part of the handover process, so I'll now turn it over to him. John is here with us today as part of the handover process, so I'll now turn it over to him. john is here with us today as part of the handover process so i'll now turn it over to him
Speaker 6: Thanks a lot, Mike, for your kind introduction, and good morning, everyone. I feel honored to be here with you all today and join Almirall at this certain point in time, a company with a tremendous legacy that keeps the patient at the center of everything it does. I'm excited for the opportunity to collaborate with Almirall's talented and passionate team, contributed to company mission and sustainable profitable growth to be delivered in upcoming years aligned with 2030 vision. I would like to thank Mike for his support and help during my onboarding. We are working very closely to ensure a smooth transition from day one with a solid focus on business continuity, building up on the woodwork that has already been accomplished. Thanks a lot, Mike, for your kind introduction, and good morning, everyone. thanks a lot mike for your kind introduction and good morning everyone I feel honored to be here with you all today and join Almirall at this certain point in time, a company with a tremendous legacy that keeps the patient at the center of everything it does. i feel honored to be here with you all today and join almirall at this certain point in time a company with a tremendous legacy that keeps the patient at the center of everything it does I'm excited for the opportunity to collaborate with Almirall's talented and passionate team, contributed to company mission and sustainable profitable growth to be delivered in upcoming years aligned with 2030 vision. i'm excited for the opportunity to collaborate with almirall's talented and passionate team contributed to company mission and sustainable profitable growth to be delivered in upcoming years aligned with 2030 vision I would like to thank Mike for his support and help during my onboarding. i would like to thank mike for his support and help during my onboarding We are working very closely to ensure a smooth transition from day one with a solid focus on business continuity, building up on the woodwork that has already been accomplished. we are working very closely to ensure a smooth transition from day one with a solid focus on business continuity building up on the woodwork that has already been accomplished I look forward to meeting many of you in the upcoming months and quarters. And with this, I would like to hand it over back to Carlos for his closing remarks. I look forward to meeting many of you in the upcoming months and quarters. i look forward to meeting many of you in the upcoming months and quarters And with this, I would like to hand it over back to Carlos for his closing remarks. and with this i would like to hand it over back to carlos for his closing remarks
Speaker 3: Thank you, Mike, and thank you, John, and and a very warm welcome. On behalf of the board and the entire Alimera team, I would like to thank Mike McClellan for his leadership and dedication during his tenure as CFO. His contributions have been instrumental in strengthening our financial foundation and supporting our strategic direction. We wish him continued success in his future endeavors. As Mike confirmed, we remain fully on track to meet our 2025 guidance and midterm outlook. Thank you, Mike, and thank you, John, and and a very warm welcome. thank you mike and thank you john and and a very warm welcome On behalf of the board and the entire Alimera team, I would like to thank Mike McClellan for his leadership and dedication during his tenure as CFO. on behalf of the board and the entire alimera team i would like to thank mike mcclellan for his leadership and dedication during his tenure as cfo His contributions have been instrumental in strengthening our financial foundation and supporting our strategic direction. his contributions have been instrumental in strengthening our financial foundation and supporting our strategic direction We wish him continued success in his future endeavors. we wish him continued success in his future endeavors As Mike confirmed, we remain fully on track to meet our 2025 guidance and midterm outlook. as mike confirmed we remain fully on track to meet our 2025 guidance and midterm outlook Our ambition is to achieve a double digit net sales compounded annual growth rate through 2030 and reach an EBITDA margin of approximately 25% by 2028. As we close the second quarter of twenty twenty five, we are encouraged by the continued momentum driven by Lumetri and Epilisk, which are propelling total sales growth into double digits. Looking ahead, we anticipate further pipeline developments in the next twelve to twenty four months. Over the past decade, we've built a strong foundation in medical dermatology, which continues to offer meaningful opportunities for both growth and margin expansion. What differentiates Almirai in this evolving landscape is a combination of scientific depth, operational excellence, a pipeline with disruptive potential, including several first and best in class assets, and our close long standing relationship with dermatologists and patient communities across Europe. Our ambition is to achieve a double digit net sales compounded annual growth rate through 2030 and reach an EBITDA margin of approximately 25% by 2028. our ambition is to achieve a double digit net sales compounded annual growth rate through 2030 and reach an ebitda margin of approximately 25% by 2028 As we close the second quarter of twenty twenty five, we are encouraged by the continued momentum driven by Lumetri and Epilisk, which are propelling total sales growth into double digits. as we close the second quarter of twenty twenty five we are encouraged by the continued momentum driven by lumetri and epilisk which are propelling total sales growth into double digits Looking ahead, we anticipate further pipeline developments in the next twelve to twenty four months. looking ahead we anticipate further pipeline developments in the next twelve to twenty four months Over the past decade, we've built a strong foundation in medical dermatology, which continues to offer meaningful opportunities for both growth and margin expansion. over the past decade we've built a strong foundation in medical dermatology which continues to offer meaningful opportunities for both growth and margin expansion What differentiates Almirai in this evolving landscape is a combination of scientific depth, operational excellence, a pipeline with disruptive potential, including several first and best in class assets, and our close long standing relationship with dermatologists and patient communities across Europe. what differentiates almirai in this evolving landscape is a combination of scientific depth operational excellence a pipeline with disruptive potential including several first and best in class assets and our close long standing relationship with dermatologists and patient communities across europe I'm proud to say that over 400,000 patients have been treated with Ardiraj's new dermatological products in 2025. And when I mean new dermatological products, I refer to Eblis, Rheumatrix, Lysuria, Winthora. Our capital allocation strategy remains disciplined and focused. We continue to invest in current and upcoming launches to drive midterm growth, strengthen our pipeline through internal R and D and in licensing, maintain a stable dividend and remain open to targeted business development and licensing opportunities, supported by a solid liquidity position and prudent financial approach. We are excited about the road ahead towards strengthening our leadership in medical dermatology. I'm proud to say that over 400,000 patients have been treated with Ardiraj's new dermatological products in 2025. i'm proud to say that over 400,000 patients have been treated with ardiraj's new dermatological products in 2025 And when I mean new dermatological products, I refer to Eblis, Rheumatrix, Lysuria, Winthora. and when i mean new dermatological products i refer to eblis rheumatrix lysuria winthora Our capital allocation strategy remains disciplined and focused. our capital allocation strategy remains disciplined and focused We continue to invest in current and upcoming launches to drive midterm growth, strengthen our pipeline through internal R and D and in licensing, maintain a stable dividend and remain open to targeted business development and licensing opportunities, supported by a solid liquidity position and prudent financial approach. we continue to invest in current and upcoming launches to drive midterm growth strengthen our pipeline through internal r and d and in licensing maintain a stable dividend and remain open to targeted business development and licensing opportunities supported by a solid liquidity position and prudent financial approach We are excited about the road ahead towards strengthening our leadership in medical dermatology. we are excited about the road ahead towards strengthening our leadership in medical dermatology With that, I will pass the word back to Pablo for Q and A. With that, I will pass the word back to Pablo for Q and A. with that i will pass the word back to pablo for q and a
Speaker 2: Thank you very much, Carlos. Heidi, back to you for the Q and A, please. Thank you very much, Carlos. thank you very much carlos Heidi, back to you for the Q and A, please. heidi back to you for the q and a please
Speaker 1: Thank We will take our first question. And the first question comes from the line of Shan Haemer from Jefferies. Please go ahead. Your line is open. Thank We will take our first question. thank we will take our first question And the first question comes from the line of Shan Haemer from Jefferies. and the first question comes from the line of shan haemer from jefferies Please go ahead. please go ahead Your line is open. your line is open
Speaker 7: Hi there. Thank you for taking my questions. Just two from me. So firstly, what are the current competitive dynamics between Eblis and Nimlivia in Europe? I know Nimlivia only launched earlier this year, but is there anything you can provide on this front? Hi there. hi there Thank you for taking my questions. thank you for taking my questions Just two from me. just two from me So firstly, what are the current competitive dynamics between Eblis and Nimlivia in Europe? so firstly what are the current competitive dynamics between eblis and nimlivia in europe I know Nimlivia only launched earlier this year, but is there anything you can provide on this front? i know nimlivia only launched earlier this year but is there anything you can provide on this front And then secondly, do you find that there's an increasing use of biologics in Europe like Eblis in biologic naive patients? Thank you. And then secondly, do you find that there's an increasing use of biologics in Europe like Eblis in biologic naive patients? and then secondly do you find that there's an increasing use of biologics in europe like eblis in biologic naive patients Thank you. thank you
Speaker 2: Sorry, Shannon. I missed the second part of or the second question. Can you please repeat it? Sorry, Shannon. sorry shannon I missed the second part of or the second question. i missed the second part of or the second question Can you please repeat it? can you please repeat it
Speaker 7: Yeah. Of course. Do you find that there's an increasing use of biologics like Eglis in Europe in biologic naive patients? Yeah. yeah Of course. of course Do you find that there's an increasing use of biologics like Eglis in Europe in biologic naive patients? do you find that there's an increasing use of biologics like eglis in europe in biologic naive patients
Speaker 3: Sure. Thank you, Shan. I think it's not no surprise that we we're seeing new entrants in atopic dermatitis because it's a tremendously exciting market with that still has tremendous unmet need potential. Yes. And NEMLLUVIO have been recently launched that has indication for porico nodularis and has a IL-thirty one mechanism. Sure. sure Thank you, Shan. thank you shan I think it's not no surprise that we we're seeing new entrants in atopic dermatitis because it's a tremendously exciting market with that still has tremendous unmet need potential. i think it's not no surprise that we we're seeing new entrants in atopic dermatitis because it's a tremendously exciting market with that still has tremendous unmet need potential Yes. yes And NEMLLUVIO have been recently launched that has indication for porico nodularis and has a IL-thirty one mechanism. and nemlluvio have been recently launched that has indication for porico nodularis and has a il-thirty one mechanism We believe if we believe that for AD, the main cytokine remain is IL-thirteen. 13. So and, you know, we could see the role that Nebulio plays in per gonadularis going forward. And in terms of the second question, the use of biologics, yes. I mean, we've seen it. We believe if we believe that for AD, the main cytokine remain is IL-thirteen. we believe if we believe that for ad the main cytokine remain is il-thirteen 13. 13 So and, you know, we could see the role that Nebulio plays in per gonadularis going forward. so and you know we could see the role that nebulio plays in per gonadularis going forward And in terms of the second question, the use of biologics, yes. and in terms of the second question the use of biologics yes I mean, we've seen it. i mean we've seen it We saw it in the past in the psoriasis market. Whereas we see new entrants, what the new entrants and new classes do is to expand the market and of because there are still a big percentage of eligible patients of moderate to severe disease that are not treated. We are seeing the same dynamics, although at an earlier stage in the atopic dermatitis market. So, yes, we believe that new entrants, what we'll do is expand the market and increase the access of these novel and exciting treatments to patients suffering from atopic dermatitis. We saw it in the past in the psoriasis market. we saw it in the past in the psoriasis market Whereas we see new entrants, what the new entrants and new classes do is to expand the market and of because there are still a big percentage of eligible patients of moderate to severe disease that are not treated. whereas we see new entrants what the new entrants and new classes do is to expand the market and of because there are still a big percentage of eligible patients of moderate to severe disease that are not treated We are seeing the same dynamics, although at an earlier stage in the atopic dermatitis market. we are seeing the same dynamics although at an earlier stage in the atopic dermatitis market So, yes, we believe that new entrants, what we'll do is expand the market and increase the access of these novel and exciting treatments to patients suffering from atopic dermatitis. so yes we believe that new entrants what we'll do is expand the market and increase the access of these novel and exciting treatments to patients suffering from atopic dermatitis
Speaker 7: Thank you. Thank you. thank you
Speaker 1: Thank you. We will take our next question. Your next question comes from the line of Guillaume Sampayya from Kegsaban. Just Thank you. thank you We will take our next question. we will take our next question Your next question comes from the line of Guillaume Sampayya from Kegsaban. your next question comes from the line of guillaume sampayya from kegsaban Just just
Speaker 8: one so two, if I may. One on Ablys. Is there any factor that we should consider when modeling Ablys sales ramp ups throughout the year or this run rate this quarter on quarter run rate that you're having in the Q1 and Q2 is a good reference? And the second one is a bit on the second half. So if I'm not mistaken, you're assuming a bit more intense OpEx in the second half versus your prior expectations. one so two, if I may. one so two if i may One on Ablys. one on ablys Is there any factor that we should consider when modeling Ablys sales ramp ups throughout the year or this run rate this quarter on quarter run rate that you're having in the Q1 and Q2 is a good reference? is there any factor that we should consider when modeling ablys sales ramp ups throughout the year or this run rate this quarter on quarter run rate that you're having in the q1 and q2 is a good reference And the second one is a bit on the second half. and the second one is a bit on the second half So if I'm not mistaken, you're assuming a bit more intense OpEx in the second half versus your prior expectations. so if i'm not mistaken you're assuming a bit more intense opex in the second half versus your prior expectations If you could provide some color on this, it would be great. And on out licensing royalty income expectations, you mentioned a €10,000,000 higher impact versus 2024. If you could provide us some bridge versus your prior expectations. Thank you. If you could provide some color on this, it would be great. if you could provide some color on this it would be great And on out licensing royalty income expectations, you mentioned a €10,000,000 higher impact versus 2024. and on out licensing royalty income expectations you mentioned a €10,000,000 higher impact versus 2024 If you could provide us some bridge versus your prior expectations. if you could provide us some bridge versus your prior expectations Thank you. thank you
Speaker 3: Good. Thank you for your questions. Mike, do you wanna take a stab at the questions? Good. good Thank you for your questions. thank you for your questions Mike, do you wanna take a stab at the questions? mike do you wanna take a stab at the questions
Speaker 5: Yeah. So, we're seeing good uptake of Evglis. So I think, you know, the the quarter on quarter growth you've seen in the last couple of quarters is probably a fairly good proxy. As we get bigger, that may slow down a little bit, but we're seeing good uptake across this. And we think we're definitely in line to meet or slightly beat the existing Street expectations. Yeah. yeah So, we're seeing good uptake of Evglis. so we're seeing good uptake of evglis So I think, you know, the the quarter on quarter growth you've seen in the last couple of quarters is probably a fairly good proxy. so i think you know the the quarter on quarter growth you've seen in the last couple of quarters is probably a fairly good proxy As we get bigger, that may slow down a little bit, but we're seeing good uptake across this. as we get bigger that may slow down a little bit but we're seeing good uptake across this And we think we're definitely in line to meet or slightly beat the existing Street expectations. and we think we're definitely in line to meet or slightly beat the existing street expectations So where do we see good good uptake there? The second half, we we we expect, you know, if you look at our our guidance range versus the first half, it'll be fairly consistent. You know, we'll we'll continue to have good sales growth. And and if you look at the EBITDA range versus where we've landed in the first half, it shows that we'll continue to have good good EBITDA growth there too. In terms of what I talked about total, outlicensing and royalties, if you look across the entire business, including, you know, outlicensing we do of of noncore products, things that we haven't launched ourselves that we're we're finding partners. So where do we see good good uptake there? so where do we see good good uptake there The second half, we we we expect, you know, if you look at our our guidance range versus the first half, it'll be fairly consistent. the second half we we we expect you know if you look at our our guidance range versus the first half it'll be fairly consistent You know, we'll we'll continue to have good sales growth. you know we'll we'll continue to have good sales growth And and if you look at the EBITDA range versus where we've landed in the first half, it shows that we'll continue to have good good EBITDA growth there too. and and if you look at the ebitda range versus where we've landed in the first half it shows that we'll continue to have good good ebitda growth there too In terms of what I talked about total, outlicensing and royalties, if you look across the entire business, including, you know, outlicensing we do of of noncore products, things that we haven't launched ourselves that we're we're finding partners. in terms of what i talked about total outlicensing and royalties if you look across the entire business including you know outlicensing we do of of noncore products things that we haven't launched ourselves that we're we're finding partners Last year, the that bucket was about 15,000,000 in total. This year, with with the first quarter transaction, we'll end up around 25,000,000 in total. So that's the ten year, the 10,000,000 gap. That also includes some ongoing royalties from older, transactions that we've done and and minor minor outlicensing in in territories like Latin America and and Asia of some assets. So nothing nothing, huge, increase. Last year, the that bucket was about 15,000,000 in total. last year the that bucket was about 15,000,000 in total This year, with with the first quarter transaction, we'll end up around 25,000,000 in total. this year with with the first quarter transaction we'll end up around 25,000,000 in total So that's the ten year, the 10,000,000 gap. so that's the ten year the 10,000,000 gap That also includes some ongoing royalties from older, transactions that we've done and and minor minor outlicensing in in territories like Latin America and and Asia of some assets. that also includes some ongoing royalties from older transactions that we've done and and minor minor outlicensing in in territories like latin america and and asia of some assets So nothing nothing, huge, increase. so nothing nothing huge increase If you look back into 2023, that bucket was about 20,000,000, so it's fairly consistent. If you look back into 2023, that bucket was about 20,000,000, so it's fairly consistent. if you look back into 2023 that bucket was about 20,000,000 so it's fairly consistent
Speaker 1: Okay. Thank you. Thank you. We will take our next question. Your next question comes from the line of Niall Alexander from Deutsche Bank. Please go ahead. Your line is open. Okay. okay Thank you. thank you Thank you. thank you We will take our next question. we will take our next question Your next question comes from the line of Niall Alexander from Deutsche Bank. your next question comes from the line of niall alexander from deutsche bank Please go ahead. please go ahead Your line is open. your line is open
Speaker 9: Hi. How's it going? It's, Neil Alexander from Deutsche Bank. Just two questions, please. On your IL-one monoclonal antibody and hydrogenated supertiva, it'd be helpful just to get your takes on the commercial opportunity there. Hi. hi How's it going? how's it going It's, Neil Alexander from Deutsche Bank. it's neil alexander from deutsche bank Just two questions, please. just two questions please On your IL-one monoclonal antibody and hydrogenated supertiva, it'd be helpful just to get your takes on the commercial opportunity there. on your il-one monoclonal antibody and hydrogenated supertiva it'd be helpful just to get your takes on the commercial opportunity there You have the likes of Benzlek doing well in that space. So just wondering how you could potentially differentiate there once you tick off the regulatory r and d studies. And then on Eglis, just obviously focusing outside of Germany, which seems to be doing well. And just looking into the regions where you have launched, it'd be helpful to get an understanding of how these are tracking, in particular, other EU five regions. You have the likes of Benzlek doing well in that space. you have the likes of benzlek doing well in that space So just wondering how you could potentially differentiate there once you tick off the regulatory r and d studies. so just wondering how you could potentially differentiate there once you tick off the regulatory r and d studies And then on Eglis, just obviously focusing outside of Germany, which seems to be doing well. and then on eglis just obviously focusing outside of germany which seems to be doing well And just looking into the regions where you have launched, it'd be helpful to get an understanding of how these are tracking, in particular, other EU five regions. and just looking into the regions where you have launched it'd be helpful to get an understanding of how these are tracking in particular other eu five regions
Speaker 3: Thank you, Nayu, for the question. So I'll give you some some flavor on the I l one, and then I'll and then please, and then I'll pass the word for Karl for further insight into the into the anti I l one. First HS, again, is a big underserved market. The unmet need remains, although there are some treatments approved in HS, the unmet need remains tremendous the sort of suffering by these patients. So very excited to have two programs that are targeting HS, both with a potential to be best in class. Thank you, Nayu, for the question. thank you nayu for the question So I'll give you some some flavor on the I l one, and then I'll and then please, and then I'll pass the word for Karl for further insight into the into the anti I l one. so i'll give you some some flavor on the i l one and then i'll and then please and then i'll pass the word for karl for further insight into the into the anti i l one First HS, again, is a big underserved market. first hs again is a big underserved market The unmet need remains, although there are some treatments approved in HS, the unmet need remains tremendous the sort of suffering by these patients. the unmet need remains although there are some treatments approved in hs the unmet need remains tremendous the sort of suffering by these patients So very excited to have two programs that are targeting HS, both with a potential to be best in class. so very excited to have two programs that are targeting hs both with a potential to be best in class The other one is extremely exciting. We have already seen the the results of phase one that confirms, you know, the profile of the product, and now we we will soon enter the POC studies. At least outside Germany, every day, but we're seeing a strong uptake even in countries where we still don't have full access because there is a regional access landscape such as Spain and Italy. We're seeing a very positive uptake of in these countries and already in some cases already being in the double digit in terms of dynamic market share. So, everything we're seeing, very positive and confirming the the potential and the role of IL-thirteen in treating AD patients. The other one is extremely exciting. the other one is extremely exciting We have already seen the the results of phase one that confirms, you know, the profile of the product, and now we we will soon enter the POC studies. we have already seen the the results of phase one that confirms you know the profile of the product and now we we will soon enter the poc studies At least outside Germany, every day, but we're seeing a strong uptake even in countries where we still don't have full access because there is a regional access landscape such as Spain and Italy. at least outside germany every day but we're seeing a strong uptake even in countries where we still don't have full access because there is a regional access landscape such as spain and italy We're seeing a very positive uptake of in these countries and already in some cases already being in the double digit in terms of dynamic market share. we're seeing a very positive uptake of in these countries and already in some cases already being in the double digit in terms of dynamic market share So, everything we're seeing, very positive and confirming the the potential and the role of IL-thirteen in treating AD patients. so everything we're seeing very positive and confirming the the potential and the role of il-thirteen in treating ad patients
Speaker 4: Maybe to add on the anti IL-one rep antibody. This antibody is a target, the coreceptor of in total six cytokines of the IL-one cytokine superfamily, IL-one alpha beta, IL-thirty three, and IL-thirty six alpha beta and gamma. Antibody that targets individual cytokines like the IL-one sesser for targeting the IL-thirty six have shown activity in heteradenitis suppurativa. And we believe by having an antibody that can combine those activities will have a chance to see a better efficacy in this very high medical need indication. Maybe to add on the anti IL-one rep antibody. maybe to add on the anti il-one rep antibody This antibody is a target, the coreceptor of in total six cytokines of the IL-one cytokine superfamily, IL-one alpha beta, IL-thirty three, and IL-thirty six alpha beta and gamma. this antibody is a target the coreceptor of in total six cytokines of the il-one cytokine superfamily il-one alpha beta il-thirty three and il-thirty six alpha beta and gamma Antibody that targets individual cytokines like the IL-one sesser for targeting the IL-thirty six have shown activity in heteradenitis suppurativa. antibody that targets individual cytokines like the il-one sesser for targeting the il-thirty six have shown activity in heteradenitis suppurativa And we believe by having an antibody that can combine those activities will have a chance to see a better efficacy in this very high medical need indication. and we believe by having an antibody that can combine those activities will have a chance to see a better efficacy in this very high medical need indication
Speaker 9: Thank you very much. Thank you very much. thank you very much
Speaker 1: Thank you. We will take our next question. Your next question comes from the line of Jamie Escobano from Banco Santander. Please go ahead. Your line is open. Thank you. thank you We will take our next question. we will take our next question Your next question comes from the line of Jamie Escobano from Banco Santander. your next question comes from the line of jamie escobano from banco santander Please go ahead. please go ahead Your line is open. your line is open
Speaker 10: Hi. Good morning. So my first question is regarding what you were commenting about Sun Pharma, an opportunity in psoriatic arthritis. Can you elaborate a little bit more on the size of this opportunity? How is this disease compared to the traditional psoriasis? Hi. hi Good morning. good morning So my first question is regarding what you were commenting about Sun Pharma, an opportunity in psoriatic arthritis. so my first question is regarding what you were commenting about sun pharma an opportunity in psoriatic arthritis Can you elaborate a little bit more on the size of this opportunity? can you elaborate a little bit more on the size of this opportunity How is this disease compared to the traditional psoriasis? how is this disease compared to the traditional psoriasis Is there already off label cells of ILUMETRI in this field? When when could you have the indication launched? And second second question is more of, you know, reviewing, like, a smaller products that this quarter were performing well just just to better understand the dynamics. Like, for example, cyclopoly was doing fine. Skilaranz was growing for the first time in several quarters just to to know if there is any specific dynamic there. Is there already off label cells of ILUMETRI in this field? is there already off label cells of ilumetri in this field When when could you have the indication launched? when when could you have the indication launched And second second question is more of, you know, reviewing, like, a smaller products that this quarter were performing well just just to better understand the dynamics. and second second question is more of you know reviewing like a smaller products that this quarter were performing well just just to better understand the dynamics Like, for example, cyclopoly was doing fine. like for example cyclopoly was doing fine Skilaranz was growing for the first time in several quarters just to to know if there is any specific dynamic there. skilaranz was growing for the first time in several quarters just to to know if there is any specific dynamic there And also WinSoda, which, least I personally thought it was more of a small product of 20,000,000, maybe 30,000,000, but it's already making a run rate of around 40,000,000. So, what's going on with this product, and what could could we expect? Thank you. And also WinSoda, which, least I personally thought it was more of a small product of 20,000,000, maybe 30,000,000, but it's already making a run rate of around 40,000,000. and also winsoda which least i personally thought it was more of a small product of 20,000,000 maybe 30,000,000 but it's already making a run rate of around 40,000,000 So, what's going on with this product, and what could could we expect? so what's going on with this product and what could could we expect Thank you. thank you
Speaker 3: Good morning. Hi, Meme. Thanks for the question. So on PSA, happy to see the positive results achieved by our partner Sun in this development. And this, again, adds to the body of evidence of filamentary being an effective treatment to a broader patient population. Good morning. good morning Hi, Meme. hi meme Thanks for the question. thanks for the question So on PSA, happy to see the positive results achieved by our partner Sun in this development. so on psa happy to see the positive results achieved by our partner sun in this development And this, again, adds to the body of evidence of filamentary being an effective treatment to a broader patient population. and this again adds to the body of evidence of filamentary being an effective treatment to a broader patient population We are now analyzing the results. We will see what we do going forward, and we will update you as soon as we have a view. Regarding your second question, yes. We are also very happy with the performance of of the a majority of the remaining of our portfolio, very impressed by Winthora. What I suggest maybe, Mike, you can you can comment on cyclopolyskilarence. We are now analyzing the results. we are now analyzing the results We will see what we do going forward, and we will update you as soon as we have a view. we will see what we do going forward and we will update you as soon as we have a view Regarding your second question, yes. regarding your second question yes We are also very happy with the performance of of the a majority of the remaining of our portfolio, very impressed by Winthora. we are also very happy with the performance of of the a majority of the remaining of our portfolio very impressed by winthora What I suggest maybe, Mike, you can you can comment on cyclopolyskilarence. what i suggest maybe mike you can you can comment on cyclopolyskilarence We have Paolo with us here as well. So maybe, Paolo, you can comment on Winthora. We have Paolo with us here as well. we have paolo with us here as well So maybe, Paolo, you can comment on Winthora. so maybe paolo you can comment on winthora
Speaker 5: Yeah. So cyclopoly, we're seeing some some small growth there. I think, you know, this is a a product where we are a market leader in in many of the OTC markets across Europe, and it's been a good year so far this year. So it is affected by seasonality of of weather because, you know, it's it's basically a nail fungus remover. And when there's better weather, people tend to wear sandals, they wanna get rid of the nail fungus. Yeah. yeah So cyclopoly, we're seeing some some small growth there. so cyclopoly we're seeing some some small growth there I think, you know, this is a a product where we are a market leader in in many of the OTC markets across Europe, and it's been a good year so far this year. i think you know this is a a product where we are a market leader in in many of the otc markets across europe and it's been a good year so far this year So it is affected by seasonality of of weather because, you know, it's it's basically a nail fungus remover. so it is affected by seasonality of of weather because you know it's it's basically a nail fungus remover And when there's better weather, people tend to wear sandals, they wanna get rid of the nail fungus. and when there's better weather people tend to wear sandals they wanna get rid of the nail fungus So this is a typical annual variance. In terms of scalarins, what we've actually seen is in the main market Germany, one of the competing products has, withdrawn from the market, another one of the DMFs. So so we will see a slight growth this year as we pick up some of that volume, but it's not going to significantly change the the the pattern. But but it's nice for us to have a small growth in that. And maybe, Paolo, you wanna address BINZORA? So this is a typical annual variance. so this is a typical annual variance In terms of scalarins, what we've actually seen is in the main market Germany, one of the competing products has, withdrawn from the market, another one of the DMFs. in terms of scalarins what we've actually seen is in the main market germany one of the competing products has withdrawn from the market another one of the dmfs So so we will see a slight growth this year as we pick up some of that volume, but it's not going to significantly change the the the pattern. so so we will see a slight growth this year as we pick up some of that volume but it's not going to significantly change the the the pattern But but it's nice for us to have a small growth in that. but but it's nice for us to have a small growth in that And maybe, Paolo, you wanna address BINZORA? and maybe paolo you wanna address binzora
Speaker 11: Hi. Hi, Meh. This is Paolo Sonini, the, commercial officer here in AMIRAI. So, we are very pleased, on the trend of we are having with, with BINZORA. Actually, as a company that want to be a leader in dermatologists, not only about biologics, but it's also offering a note to patients and dermatologists the full spectrum of treatment and, in psoriasis. Hi. hi Hi, Meh. hi meh This is Paolo Sonini, the, commercial officer here in AMIRAI. this is paolo sonini the commercial officer here in amirai So, we are very pleased, on the trend of we are having with, with BINZORA. so we are very pleased on the trend of we are having with with binzora Actually, as a company that want to be a leader in dermatologists, not only about biologics, but it's also offering a note to patients and dermatologists the full spectrum of treatment and, in psoriasis. actually as a company that want to be a leader in dermatologists not only about biologics but it's also offering a note to patients and dermatologists the full spectrum of treatment and in psoriasis I mean, we are basically among the the the few companies, actually, the only company offering everything basically from, my disease to the very severe or a complete portfolio, on treating psoriasis. So about WinZora, we are pleased because the sales are catching up in the countries, the most relevant countries where we are operating with such a product. And, and also about the penetration of the market where we are already double digit, high double digit, I would say, in market penetrations, in market share, not only in dynamic but overall. And, and with ZORA showing that through this PAD technology that give us the possibility really to give an options to the patient that is much better than the the available products. I mean, we are really, seeing an increasing penetration of the market, and we will continue like that even in the future. I mean, we are basically among the the the few companies, actually, the only company offering everything basically from, my disease to the very severe or a complete portfolio, on treating psoriasis. i mean we are basically among the the the few companies actually the only company offering everything basically from my disease to the very severe or a complete portfolio on treating psoriasis So about WinZora, we are pleased because the sales are catching up in the countries, the most relevant countries where we are operating with such a product. so about winzora we are pleased because the sales are catching up in the countries the most relevant countries where we are operating with such a product And, and also about the penetration of the market where we are already double digit, high double digit, I would say, in market penetrations, in market share, not only in dynamic but overall. and and also about the penetration of the market where we are already double digit high double digit i would say in market penetrations in market share not only in dynamic but overall And, and with ZORA showing that through this PAD technology that give us the possibility really to give an options to the patient that is much better than the the available products. and and with zora showing that through this pad technology that give us the possibility really to give an options to the patient that is much better than the the available products I mean, we are really, seeing an increasing penetration of the market, and we will continue like that even in the future. i mean we are really seeing an increasing penetration of the market and we will continue like that even in the future
Speaker 3: Thank you very much. Thank you very much. thank you very much
Speaker 1: Thank you. We will take your next question. The next question comes from the line of Francisco Roos from BNP Paribas. Please go ahead. Your line is open. Thank you. thank you We will take your next question. we will take your next question The next question comes from the line of Francisco Roos from BNP Paribas. the next question comes from the line of francisco roos from bnp paribas Please go ahead. please go ahead Your line is open. your line is open
Speaker 12: Hi. Good morning. First, I would like to thank Mike for the help during all this year, I wish him the best luck in the next developments. And I also welcome, John. I have two questions. Hi. hi Good morning. good morning First, I would like to thank Mike for the help during all this year, I wish him the best luck in the next developments. first i would like to thank mike for the help during all this year i wish him the best luck in the next developments And I also welcome, John. and i also welcome john I have two questions. i have two questions One is a follow-up from Jaime, which is that the €30,000,000 peak sales that you expect in ILUMEDIT does not include this new psoriasis arthritis therapy. And the second one, as always, I asked about the milestones in the coming quarters. So if you could give up a date after the €50,000,000 that we sold in this first half, what is remaining for the second half and what's already known for 2026? Thank you. One is a follow-up from Jaime, which is that the €30,000,000 peak sales that you expect in ILUMEDIT does not include this new psoriasis arthritis therapy. one is a follow-up from jaime which is that the €30,000,000 peak sales that you expect in ilumedit does not include this new psoriasis arthritis therapy And the second one, as always, I asked about the milestones in the coming quarters. and the second one as always i asked about the milestones in the coming quarters So if you could give up a date after the €50,000,000 that we sold in this first half, what is remaining for the second half and what's already known for 2026? so if you could give up a date after the €50,000,000 that we sold in this first half what is remaining for the second half and what's already known for 2026 Thank you. thank you
Speaker 3: Yeah. Sure. Hi, Francisco. Yes. The 300,000,000 over 300,000,000 peak sales estimate for ILUMETRI does not include additional indications such as PSA. Yeah. yeah Sure. sure Hi, Francisco. hi francisco Yes. yes The 300,000,000 over 300,000,000 peak sales estimate for ILUMETRI does not include additional indications such as PSA. the 300,000,000 over 300,000,000 peak sales estimate for ilumetri does not include additional indications such as psa It's only based on PSO. Mike, do you wanna take the milestone question? It's only based on PSO. it's only based on pso Mike, do you wanna take the milestone question? mike do you wanna take the milestone question
Speaker 5: Yeah. So so far, you know, I think we're we're still on track to to have total investments this year, you know, between 70 and 80,000,000, absent any large significant new transaction. And and the difference between where we are at the the the half year and the second half means we'll have much less in the second half. It's really just going to be small things based on existing agreements. We may trigger, you know, larger milestones to be paid next year, but I would expect next year to be somewhere in that same ballpark, roughly 80,000,000, of course, absent any new, m and a or in licensing transactions. Yeah. yeah So so far, you know, I think we're we're still on track to to have total investments this year, you know, between 70 and 80,000,000, absent any large significant new transaction. so so far you know i think we're we're still on track to to have total investments this year you know between 70 and 80,000,000 absent any large significant new transaction And and the difference between where we are at the the the half year and the second half means we'll have much less in the second half. and and the difference between where we are at the the the half year and the second half means we'll have much less in the second half It's really just going to be small things based on existing agreements. it's really just going to be small things based on existing agreements We may trigger, you know, larger milestones to be paid next year, but I would expect next year to be somewhere in that same ballpark, roughly 80,000,000, of course, absent any new, m and a or in licensing transactions. we may trigger you know larger milestones to be paid next year but i would expect next year to be somewhere in that same ballpark roughly 80,000,000 of course absent any new m and a or in licensing transactions
Speaker 12: Okay. Well, thank you. Okay. okay Well, thank you. well thank you
Speaker 1: Thank you. We will take our next question. Your next question comes from the line of Jochen Garcia Guerra Gonzalez Pammino from JP Capital. Please go ahead. Your line is open. Thank you. thank you We will take our next question. we will take our next question Your next question comes from the line of Jochen Garcia Guerra Gonzalez Pammino from JP Capital. your next question comes from the line of jochen garcia guerra gonzalez pammino from jp capital Please go ahead. please go ahead Your line is open. your line is open
Speaker 13: Yes. Hello. Thank you for taking my question. Just I want to have a bit more insight on Tliceria in The US. It's growing but still very small. Yes. yes Hello. hello Thank you for taking my question. thank you for taking my question Just I want to have a bit more insight on Tliceria in The US. just i want to have a bit more insight on tliceria in the us It's growing but still very small. it's growing but still very small So I want to to know if large flow is really having, an effect there. And then despite that, US operations continue to to decline year on year. So what's your, what what are you going to do in the future if this continues? Will you, consider closing, The US operations, or that's not something you're currently considering? Thank you. So I want to to know if large flow is really having, an effect there. so i want to to know if large flow is really having an effect there And then despite that, US operations continue to to decline year on year. and then despite that us operations continue to to decline year on year So what's your, what what are you going to do in the future if this continues? so what's your what what are you going to do in the future if this continues Will you, consider closing, The US operations, or that's not something you're currently considering? will you consider closing the us operations or that's not something you're currently considering Thank you. thank you
Speaker 3: Hello, Joaquin. Thanks for the question. About The US, we remain on on plan a that we've shared with with you a few times. One is to to stabilize the the the the company with the current portfolio and resume it to the growth trajectory. This year, we're still planning to finish any EBITDA neutral. Hello, Joaquin. hello joaquin Thanks for the question. thanks for the question About The US, we remain on on plan a that we've shared with with you a few times. about the us we remain on on plan a that we've shared with with you a few times One is to to stabilize the the the the company with the current portfolio and resume it to the growth trajectory. one is to to stabilize the the the the company with the current portfolio and resume it to the growth trajectory This year, we're still planning to finish any EBITDA neutral. this year we're still planning to finish any ebitda neutral Once, you know, we maximize the existing portfolio, then we we are looking for bolt on opportunities that that cannot, you know, in the future, that cannot further growth. And then whilst we wait for our pipeline to deliver, as reminder, we have The US rights in all the assets that we have in our portfolio, including the exciting assets that we were talking about just a few minutes ago, such as the anti IL-one. And sorry about Viciri, Kogin. Yes. I think we we are happy with the the launch of the large field. Once, you know, we maximize the existing portfolio, then we we are looking for bolt on opportunities that that cannot, you know, in the future, that cannot further growth. once you know we maximize the existing portfolio then we we are looking for bolt on opportunities that that cannot you know in the future that cannot further growth And then whilst we wait for our pipeline to deliver, as reminder, we have The US rights in all the assets that we have in our portfolio, including the exciting assets that we were talking about just a few minutes ago, such as the anti IL-one. and then whilst we wait for our pipeline to deliver as reminder we have the us rights in all the assets that we have in our portfolio including the exciting assets that we were talking about just a few minutes ago such as the anti il-one And sorry about Viciri, Kogin. and sorry about viciri kogin Yes. yes I think we we are happy with the the launch of the large field. i think we we are happy with the the launch of the large field Now we see a majority of prescriptions going to large field versus the small field, and we plan to see the this this this trajectory continued. So not only the molecule is growing based on the the actual sulfur product, but also we're seeing the mix between the large and the small shifting towards favorably towards the natural. And we continue these to us to continue doing this in this trend. Now we see a majority of prescriptions going to large field versus the small field, and we plan to see the this this this trajectory continued. now we see a majority of prescriptions going to large field versus the small field and we plan to see the this this this trajectory continued So not only the molecule is growing based on the the actual sulfur product, but also we're seeing the mix between the large and the small shifting towards favorably towards the natural. so not only the molecule is growing based on the the actual sulfur product but also we're seeing the mix between the large and the small shifting towards favorably towards the natural And we continue these to us to continue doing this in this trend. and we continue these to us to continue doing this in this trend
Speaker 12: Thank you. Thank you. thank you
Speaker 1: Thank you. We will take our next question. Your next question comes from the line of Alvaro Lens from Altrauner Equities. Please go ahead. Your line is open. Thank you. thank you We will take our next question. we will take our next question Your next question comes from the line of Alvaro Lens from Altrauner Equities. your next question comes from the line of alvaro lens from altrauner equities Please go ahead. please go ahead Your line is open. your line is open
Speaker 14: Hi. Thanks for taking my questions. The first one is on this market share. You mentioned you're in the double digits in Germany. I don't know if you have a similar figure or available data for France, in particular, after you launched this quarter? Hi. hi Thanks for taking my questions. thanks for taking my questions The first one is on this market share. the first one is on this market share You mentioned you're in the double digits in Germany. you mentioned you're in the double digits in germany I don't know if you have a similar figure or available data for France, in particular, after you launched this quarter? i don't know if you have a similar figure or available data for france in particular after you launched this quarter My second question would be in terms of pricing, if you could provide whether pricing in the new launches missing any change and also if you could see potential for price upgrades in the future or if there are any any discussions given the the most favored nation discussions in The United States. I don't know if you see any read across that that could push, in order to drop prices in Europe up in order to compensate for a potential decline in U. S. Prices by big pharma. Thank you. My second question would be in terms of pricing, if you could provide whether pricing in the new launches missing any change and also if you could see potential for price upgrades in the future or if there are any any discussions given the the most favored nation discussions in The United States. my second question would be in terms of pricing if you could provide whether pricing in the new launches missing any change and also if you could see potential for price upgrades in the future or if there are any any discussions given the the most favored nation discussions in the united states I don't know if you see any read across that that could push, in order to drop prices in Europe up in order to compensate for a potential decline in U. i don't know if you see any read across that that could push in order to drop prices in europe up in order to compensate for a potential decline in u S. s Prices by big pharma. prices by big pharma Thank you. thank you
Speaker 3: So thank you, Alvaro, for the questions. So thank you, Alvaro, for the questions. so thank you alvaro for the questions Please, France, it's it's it's early days to to stop talking about percentages of uptake. What we see is very consistent with what we've seen in in in other markets where we have launched earlier. That that means good feedback, anecdotal, good feedback from physicians, willingness to try. Those that have already experienced with the product, signaling that they are willing to use it more. So quite consistent inputs coming from France compared to to previous, countries where where we have launched base. Please, France, it's it's it's early days to to stop talking about percentages of uptake. please france it's it's it's early days to to stop talking about percentages of uptake What we see is very consistent with what we've seen in in in other markets where we have launched earlier. what we see is very consistent with what we've seen in in in other markets where we have launched earlier That that means good feedback, anecdotal, good feedback from physicians, willingness to try. that that means good feedback anecdotal good feedback from physicians willingness to try Those that have already experienced with the product, signaling that they are willing to use it more. those that have already experienced with the product signaling that they are willing to use it more So quite consistent inputs coming from France compared to to previous, countries where where we have launched base. so quite consistent inputs coming from france compared to to previous countries where where we have launched base Pricing pricing, well, as we mentioned a few times, so, we were very happy to see that the health systems in the different countries wanted, new treatments for atopic dermatitis, and then there's a testament of the severe unmet need that remains in this indication. And therefore, we've seen, you know, the the pricing levels that we were expecting, in some cases, maybe slightly better. But also, as we've mentioned a few times also in these calls, we've got reimbursement ahead of in some cases, of the standard times. Right? So overall, in in the market access front, pricing and reimbursement, positive from that side. Pricing pricing, well, as we mentioned a few times, so, we were very happy to see that the health systems in the different countries wanted, new treatments for atopic dermatitis, and then there's a testament of the severe unmet need that remains in this indication. pricing pricing well as we mentioned a few times so we were very happy to see that the health systems in the different countries wanted new treatments for atopic dermatitis and then there's a testament of the severe unmet need that remains in this indication And therefore, we've seen, you know, the the pricing levels that we were expecting, in some cases, maybe slightly better. and therefore we've seen you know the the pricing levels that we were expecting in some cases maybe slightly better But also, as we've mentioned a few times also in these calls, we've got reimbursement ahead of in some cases, of the standard times. but also as we've mentioned a few times also in these calls we've got reimbursement ahead of in some cases of the standard times Right? right So overall, in in the market access front, pricing and reimbursement, positive from that side. so overall in in the market access front pricing and reimbursement positive from that side The future about price upgrades, well, well, in Europe Europe, you know, that's that's have yet to have a see Europe revising pricing upwards. Yes. Now there's an opportunity for Europe given the geopolitical events and the US administration policies to for you to get the act together and start rewarding innovation in a different way. So, let's see what the developments are in this in this front. The future about price upgrades, well, well, in Europe Europe, you know, that's that's have yet to have a see Europe revising pricing upwards. the future about price upgrades well well in europe europe you know that's that's have yet to have a see europe revising pricing upwards Yes. yes Now there's an opportunity for Europe given the geopolitical events and the US administration policies to for you to get the act together and start rewarding innovation in a different way. now there's an opportunity for europe given the geopolitical events and the us administration policies to for you to get the act together and start rewarding innovation in a different way So, let's see what the developments are in this in this front. so let's see what the developments are in this in this front
Speaker 14: Thank you. Thank you. thank you
Speaker 1: Thank you. There are no further questions. I would like to hand back to Pablo Diverson for closing remarks. Thank you. thank you There are no further questions. there are no further questions I would like to hand back to Pablo Diverson for closing remarks. i would like to hand back to pablo diverson for closing remarks
Speaker 2: Thank you very much, Heidi. As there are no further questions, ladies and gentlemen, this concludes our today's conference call. Thank you for your participation. You may now disconnect. Thank you very much, Heidi. thank you very much heidi As there are no further questions, ladies and gentlemen, this concludes our today's conference call. as there are no further questions ladies and gentlemen this concludes our today's conference call Thank you for your participation. thank you for your participation You may now disconnect. you may now disconnect
Speaker 1: This concludes today's conference call. Thank you for participating. You may now disconnect. This concludes today's conference call. this concludes today's conference call Thank you for participating. thank you for participating You may now disconnect. you may now disconnect