Today, and thank you for standing by. Welcome to the Almirall Q1 2025 financial results and business update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pablo Divasson, Head of Investor Relations. Please go ahead.
Thank you very much, Sandra. Good morning, Almirall. Thank you for joining us for today's quarterly earnings update and review of Almirall's first quarter financial results of 2025. As always, we are sharing the slides we are using today in the investor section of our website at almirall.com. Please move to slide number two. Let me remind you that the information presented in this call contains forward-looking statements, which involve known and unknown risk, 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 McClellan, Chief Financial Officer; and Karl Ziegelbauer, Chief Scientific Officer. Carlos will start with the business highlights covering the first quarter of 2025, followed by an update especially on biologics as the key growth drivers on our medical dermatology portfolio.
Karl will provide you with an R&D status update regarding our pilot. Mike will then talk you through the financials before Carlos concludes the presentation, and we open for questions. I will hand over to Carlos Gallardo, our Chairman and CEO. Please move to slide number five.
Thank you, Pablo. We are delighted to share with you that we have started the year with continued strong business performance that is very much aligned with the long-term trajectory of sustained growth we have outlined for Almirall recently. Therefore, we are pleased to confirm our full-year guidance for 2025, our midterm outlook, and PIXA's projections. This represents another quarter in the right direction in our ambition to transform the lives of patients suffering from dermatology skin conditions. Ebglyss delivered strong sales during the first quarter of 2025, benefiting from the dynamic German market, but also from initial contributions from launches in additional countries. Ilumetri continues to show year-on-year growth, and we confirm our recently updated PIXA's projections. Additionally, Wynzora and Klisyri continue to support our sales in Europe. We remain very active in the medical community, and this first quarter has not been an exception.
As an illustration, we've been at the 2025 Annual American Academy of Dermatology meeting, where we showcase our success in AK treatment with Actikerall and shared exciting phase one data on our anti-IL-1 drug. We were also present at the 16th Skin Academy in Barcelona, and this is our flagship medical educational event, where we had over 800 delegates from different countries taking part in advancing the skin treatment. We lastly participated in the 11th World Congress of Melanoma and the 21st European Association of Dermato-Oncology Congress in Athens, hosting over 1,200 healthcare professionals. This is very important for us, this interaction with medical professionals, and we constantly seek external opportunities in the early and mid-stages of clinical development in order to enhance our portfolio and impact the dermatology field. Please move to slide seven for an update on our biologics portfolio.
Ilumetri and the anti-IL-23 class have continued to secure a strong position in the psoriasis market. Ilumetri's market share remains solid, underpinned by the recent introduction of the 200 mg presentation. This new treatment option has been very well received and is contributing to our robust performance. Net sales for Ilumetri are at 13% year-on-year, reaching EUR 55 million in the first quarter of 2025. I would like to reiterate our recently upgraded PIXA projection of over EUR 300 million and underscore our confidence on Ilumetri's continued growth and its potential to make a significant impact in the psoriasis treatment landscape. Please move to the next slide for Eblas highlights. Eblas has shown strong performance after being on the market for just over a year. Starting with the December 2023 launch in Germany, cumulative sales since then have reached over EUR 54 million.
We consider this the best launch in atopic dermatitis in recent years. Our strategic focus has allowed us for a strong initial uptake in Germany, positioning us well to launch in other European markets. Within a year of launch, we have reached the second-highest dynamic new patient share in Germany. Also, reimbursement pricing in Germany and in other countries is either in line with our expectations or even slightly better, and brand awareness is strong, exceeding the average within one year of launching in various markets. Sales in the first quarter increased by 52% quarter on quarter, reaching EUR 19.4 million, driven largely by Germany, but as I said before, also we're seeing the contribution of recently launched regions beyond Germany. Our good partnership with Lilly is leading to fruitful exchanges and key learnings. Let's move to the next slide for more details on the launch timeline.
Eblas has already been launched now in all key countries in Europe, which combined represent more than 90% of the total sales potential in the region. We are progressing with launches in new European markets and have seen significant advancements since the German launch back in December 2023. As of today, Eblas is available for commercial reimbursement in 13 countries in Europe, including France, as of last month, April 2025. We are very excited about this new launch as France represents a very important market for us. It is important to reemphasize that we have been able to secure solid price levels in the launch markets. This is a prime example of how the desire for alternative treatments in atopic dermatitis is significant in the different national healthcare systems.
Next, please move to slide 11, where I invite Karl to give us an update on our positive R&D and pipeline progress.
Thank you, Carlos, and good morning, everyone on the call. This slide shows you the progress of our pipeline. Sarecycline's regulatory review in China is ongoing. We expect approval in the second half of 2025. For Skilarence, expansion to large fields in Europe, we are finishing a clinical study aiming to launch in 2026. Together with our partners, we continue to work on expanding the labels for our key products, Ilumetri and Eblas. Our partner Sun Pharma is running two phase research studies to assess efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. First results are being expected in the second half of 2025. Together with our partner, Eli Lilly, we're running a joint clinical development program to make Eblas available to additional patient populations. I will give more details on the next slide.
We have created an exciting early clinical pipeline addressing novel mechanisms and best-in-class compounds in high medical need diseases. In the next year, we plan to initiate four proof-of-concept phase two clinical studies across a spectrum of different dermatological diseases. Let me highlight a few assets. For our anti-IL-1 receptor monoclonal antibody, we have completed phase one single and ascending doses in healthy volunteers and presented the results at the recent AAD meeting. Overall, our anti-IL-1 receptor monoclonal antibody demonstrated a favorable safety and tolerability profile in healthy volunteers, along with a low immunogenicity risk supporting its further development for the treatment of immune-mediated inflammatory skin disorders. We plan to start a phase two study later this year in hidradenitis suppurativa. Let me also highlight that we are advancing KKN-013 in phase one as a potential new treatment for severe dermatological indications such as dystrophic epidermolysis bullosa and junctional epidermolysis bullosa.
ZKN-013 is an oral readthrough inducer designed to overcome nonsense mutation that caused a premature stop codon. In summary, we are progressing with both our early and late-stage pipeline. Now, let's move to slide 12. This slide shows the comprehensive joint clinical development program for Eblas with our partner Eli Lilly. This joint program will allow us to make Eblas available to additional patient populations or in different settings. Let me highlight some of the studies. Along with launching Eblas this year in all European markets, we will complement our excellent clinical data package with real-world evidence studies. One example is the so-called AD-Trust study I highlighted in the last call. To make Eblas available to all patients with atopic dermatitis, our partner Eli Lilly is running a phase three study exploring the safety and efficacy of Eblas in patients six months to under 18 years.
Primary completion is expected in 2026. Furthermore, our partner Eli Lilly has started the AD-Touch study exploring efficacy and safety of lebrikizumab in adults and adolescents with moderate to severe atopic hand and foot dermatitis. Atopic hand and foot dermatitis is a frequent, chronic, and difficult-to-treat condition. It can substantially impact a patient's quality of life. There is tremendous interest from academic investigators in further exploring lebrikizumab in different indications or settings. For example, Professor Johan Gudjonsson from the University of Michigan, a leading expert in applying genomics technology to advance the molecular understanding of inflammatory skin diseases, will be the lead investigator for the so-called AD-FIND study. AD-FIND is a mechanistic study aimed at understanding at the cellular and molecular level the changes in the skin of patients suffering from moderate to severe atopic dermatitis when treated with lebrikizumab.
Finally, in addition to the two studies in perennial allergic rhinitis and chronic rhinocitis with nasal polyps our partner Eli Lilly is running, we continue to explore new indications for which IL-13 is hypothesized to be a key pathogenic driver. With that, I will hand over to Mike for the financial review.
Thank you, Karl, for the update on our R&D progress and pipeline activities. As Carlos mentioned earlier, we're excited to start off the year on a positive note. We displayed solid performance in the first quarter of 2025 with a 15% net sales increase year-on-year. Please bear in mind that this includes the recently announced outlicensing of Algidol and Cecison in Spain. Excluding the impact of this transaction, net sales growth for Q1 would land around 10%, aligned with our 2025 guidance. The full-year net impact should be approximately EUR 15 million at the EBITDA level. We're very pleased with the growth of our European dermatology portfolio, which continues to boost our overall net sales. This is a key pillar in our journey towards leadership in medical dermatology.
Our gross margin came in at 66.9%, aided by the effects of the outlicensing transaction in Q1, but up slightly from 2024, excluding this impact. We achieved a total EBITDA of EUR 70.9 million in Q1 2025, up 35% versus Q1 2024. This was driven by robust net sales growth and the previously mentioned outlicensing. Excluding this outlicensing, our EBITDA margin in the quarter would have landed in the low 20%. SG&A in Q1 2025 is up 9.6% to EUR 122.8 million. We have driven investments in recent and upcoming EBITDA launches to support the brand's growth trajectory as Q1 2024 did not have the full staffing yet in the recent launch countries. R&D investment is up 34% year-on-year, representing 12.5% of net sales, in line with our annual target to advance our pipeline and future growth strategy.
The high growth rate versus prior year is due to phasing impacts as Q1 2024 was lighter before a second-half ramp-up last year. We ended the first quarter with a net debt-to-EBITDA ratio of 0.1 times, positioning us very well for potential licensing or bolt-on M&A opportunities. Although this gives us confidence to reiterate our full-year 2025 guidance, we remain on track with the midterm outlook and peak sales updates announced earlier in the year. Let's move on to the details of our sales breakdown in slide 15. The European dermatology business displayed a very strong performance, growing 23.4% year-on-year, which I'll cover in the next slide.
Our general medicine and OTC sales growth in Europe was driven mainly by the recent outlicensing activity, with the rest of the business flat due to a late allergy season and the ongoing decline of Epaseep Tessavel, which was offset by strong Almix performance. The full-year outlicensing and royalty income for the company will be relatively similar to 2024 and prior years, with roughly EUR 15 million in this total bucket in 2024 and EUR 20-25 million in this total bucket for 2025, including the Q1 activity. This is part of our normal portfolio value maximization strategy. Our U.S. business declined slightly, and I'll share more details with that on the next slide. The performance of our general medicine unit in the rest of the world is down, primarily due to lower Evistel and Immunorix sales. Let's take a closer look at our dermatology business on the next slide.
As mentioned by Carlos, our European dermatology segment continues to thrive, with Ilumetri and Eblas as the primary drivers. Other growth drivers, such as Skilarence and Wynzora, are making progress with their launches in key European markets. Eblas sales reached EUR 19.4 million in the first quarter, becoming our second-ranked dermatology product after just over one year on the market. This result is in line with our expectations and enhances our confidence in its strong growth trajectory. The U.S. business is generally stable, with Seysara sales in line with the prior year. The positive impact of the recent large field launch for Skilarence in August is starting to take effect, and the overall trend has grown since launch. The U.S. legacy business remains under pressure from ongoing generic pressure related to Cordran tape and aspirin, although Actikerall sales have picked up year-on-year.
Dermatology sales and robotic worthwhile lines include Novinriff, Injuvi, and Ciclopoly income. Now, let's move on to the complete financial statements on slide 16. Let's review the revenue of Eblas, starting with some elements Carlos mentioned earlier. The gross margin for Q1 2025 increased to 66.9%. As we mentioned earlier, this is largely due to the one-time impact of the outlicensing deal, with a slight increase in the underlying business due to better product mix. We anticipate some gross margin pressure for the full year versus 2024 due to sales mix and higher royalty tiers as Ilumetri sales increase, and we maintain our full-year expectations, as mentioned in our February call, which included this outlicensing transaction. Our R&D investments have risen to 12.5% in net sales, up from 10.7% in Q1 of 2024, and we expect this 12%-ish level to remain steady during the year to support our innovation strategy.
SG&A investments grew by almost 10% compared to Q1 2024. We expect this trend to continue as we focus on launching Eblas in new markets and support existing ones, but the growth will decelerate somewhat in the second half once we reach periods with comparable structures. Financial expenses have benefited from a EUR 3.9 million improvement year-on-year, primarily due to the positive equity swap valuation driven by recent share price gains. Bear in mind that our effective tax rate is influenced by the inability to offset U.S. tax losses against our profitable European business. We anticipate this will continue in 2025, and we should land in the mid-40% range of effective tax rate before declining in 2026 and beyond into the mid-20% range, as we mentioned in the full-year call. Please move to the next slide and take a look at the balance sheet.
The main highlight on the balance sheet is the impact of the investments in intangible assets during the quarter. In addition to R&D capitalization related to Eblas, key investments also include a milestone upon a successful phase I of our anti-IL-1 receptor program, which we in-licensed from ICNOS in 2021. The total impact has been outweighed by higher depreciation. Our net debt ratio remains solid at 0.1 times, allowing for more flexibility in organic growth opportunities. Let's take a look at the cash flow statement next. We generated an operating cash flow of EUR 26.4 million in Q1 2025, despite significant challenges in working capital compared to Q1 2024 due to the Eblas launch in new countries and higher receivables from the higher sales. We were able to partially offset this with the increase in profit before tax, which was in our favor.
Other adjustments mainly relate to financial income, including the equity swap. Cash outflows associated with investments are much lower in Q1 2025 than Q1 2024. This is largely due to substantial payments made last year, including a EUR 45 million milestone for Eblas and its first EU sales, and EUR 20 million for Ilumetri. We anticipate an additional EUR 45 million Ilumetri sales milestone to be made in Q1 of 2025. The remaining Q1 investments were minor payments on existing agreements. With that, I hand back to Carlos for the closing remarks.
Thank you, Mike. Thank you, Karl. We reiterate our 2025 guidance and midterm outlook, aiming for double-digit net sales CAGR by 2030 and reaching approximately 25% EBITDA margin by 2028. As we kick off 2025, we're pleased to see accelerating growth, as Ilumetri and Eblas drive total sales growth into double digits. In terms of R&D, we anticipate more exciting pipeline updates in the next 12-24 months. Over the past decade, we have built a successful platform in medical dermatology, and now several factors set us apart in the field, positioning us well in growing markets with numerous unmet needs. First, we possess a strong scientific and innovation capability. Second, we have a robust pipeline with disruptive potential, featuring several first-in-class and best-in-class molecules. Finally, our close relationship with dermatologists and patient groups across Europe gives us a competitive edge.
Our capital allocation focuses on four principles: investing in current and future product launches in dermatology to drive acceleration in midterm revenue growth, strengthening our pipeline via proprietary research and in-licensing assets, maintaining a stable dividend for shareholders, and exploring inorganic growth whilst maintaining a prudent financial policy and solid liquidity. We are very excited to lead Almirall into the next phase of our journey towards becoming leaders in medical dermatology and look forward to continued growth in the coming years. With this, we conclude the presentation, and I hand it back to Pablo for the Q&A.
Thank you very much, Carlos. Sandra, back to you for the Q&A, please.
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take the first question from the line of Xiang Hamza from Jefferies. Please go ahead.
Hi, thank you so much. Just two from me, please. Could you give us an insight into perhaps any physician and patient feedback on positioning, especially versus Dupixent? In terms of streamlining the business further and increasing your R&D engine, should we expect more of these divestments, particularly of your mature derm business and perhaps your OTC business? Thank you so much.
Please, could you repeat the first question?
I can repeat it.
Yeah, of course. In terms of physician and patient feedback on Eblas and positioning versus Dupixent? Thank you.
Yes, I can start with the first question. The feedback overall is extremely positive. Physicians value that they can use Eblas in all different kinds of patients, also specifically in difficult-to-treat patients, and they see a very fast onset of symptoms. I think with the entire clinical task, even after all the experience from the market, we believe that Eblas has a profile that allows us to position it as a first-line treatment for atopic dermatitis.
Yeah, and I can cover the question about divestments. As I mentioned in my remarks, we do not expect significant divestments or outlicensing income. Last year, we had about EUR 15 million in total between small activities and royalties. This year, we expect around EUR 20-25 million. This is just part of some minor non-derma value maximization we do in portfolio. In terms of the derma products, we do do some outlicensing of the products that we have not launched, like Fingivi and Terabenafene, but we do not expect to do any major transactions in terms of reshaping the company. Nothing significant is on the plans in the near term.
Thank you. We will now take the next question from the line of Guillermo Sampayo from Kaiser Bank. Please go ahead.
Hello. Thank you for taking my questions. Two again, if I may. On Eblas, if you could quantify a bit the share of Germany's sales in Q1 and note any stocking effect in other countries that we should be aware of when extrapolating for the full year. I remember that at the time of Q4 results, consensus was about EUR 95 million sales for Eblas for this year. Is this still a level that you're comfortable with? The second question, in terms of Ilumetri, should we think that in terms of phasing of growth going forward, this low double-digit % growth is about the level that we should expect? Thank you.
Guillermo, thank you for the question. In terms of Eblas, we see already other countries, as I mentioned, starting to continue in terms of sales. We are seeing a healthy growth now coming in in terms of mix of German sales and other countries. We remain very comfortable with the consensus for the full year. As we are getting in, we keep getting exceptional feedback from physicians throughout the different countries where we have launched. On Ilumetri, given that we have Paolo here, maybe Paolo, do you want to comment on the second question of Guillermo?
Yeah, sure. Hi, everyone. This is Paolo Cionini, the Chief Commercial Officer. The market in psoriasis, of course, is a mature market, and IL-23 class is the class basically leading the growth in this market. Our positions, I think, are quite strong with the double-digit market share. We are happy with the positions we are taking and with the trend of the product. We expect the market, of course, being more mature in the future and Ilumetri staying in the market and keeping the competitive positions we have.
I would like also to mention that we have recently launched the 200 mg, which is something extremely important because we are the only IL-23 with two dosages to give an opportunity to both patients and dermatologists to be flexible with their patients and manage at the right levels, eventually flares and periods where the variability of the disease can change. I think that thanks to these 200 mg, we can also strengthen our positions into the market.
Okay, thank you.
Thank you. We will now take the next question from the line of Álvaro Lenze from Alantra Equities. Please go ahead.
Hi, thanks for taking my questions. The first one is if you could provide some detail on the pricing in France since you launched. How does it compare to Germany and other European countries? Second question on Klisyri, if you can provide some detail on the trends there because we are not seeing much of a pickup in revenue contribution despite the label extension. Lastly, I did not get your comments on milestone payments for the year. I got some EUR 45 million paid for Ilumetri in Q1, but that does not seem to show up in the cash flow statement, or maybe I am looking at it wrong. Thank you.
Thank you, Álvaro, for the questions. We are extremely pleased with our new launch in France. This is a fundamental, very important market for us, for biologics. We have been able to secure an attractive price, and we have been able to launch it even ahead of what we had in our schedule. That is great news. Again, that is testimony, as we mentioned in my earlier remarks, of the great work that the team is doing on the ground for us in France, but also the eagerness of the health systems. France has not been an exception to adopt Eblas as this tremendous unmet need still remains in the treatment of atopic dermatitis.
We don't comment specifically on its price country per country, but what I can say is that it's a price that was in our plan, and we have achieved it, so very pleased about it. Klisyri, large field continues to contribute. In the U.S., it's not eating into the share of the small field, so it's additive. So far, the progression is good. The question was on milestones, right? Mike, do you want to comment on that?
Yes, yes. I'll take the milestone question. Sorry if it wasn't clear. When I talked about the EUR 45 million for Ilumetri, that'll be a Q2 payment. We had quite a few in Q1 last year, not much in Q1 this year. We'll have a Q2. The overall full-year milestones in investments, I would say, would probably land between EUR 70 million-EUR 80 million this year, very similar to last year's full-year cash flow, just a little bit of a different quarterly pattern.
Thank you. That's very helpful.
Thank you. As a reminder, if you wish to ask a question, please press star one and one. We will now take the next question from the line of Jaime Escribano from Banco Santander. Please go ahead.
Hi, good morning. A couple of questions from my side, or maybe three. First one on gross margin. Gross margin excluding the sale, I get something like more than 65%. This is a little bit higher than the usual. I think your guidance was more closer to 64% or so, so better than expected. Just to understand what is behind that and what should we expect for the rest of the year. Second question regarding your guidance for the year. If we do a simple run rate EBITDA taking Q1 without the asset sale, plus the asset sale, you get to the high part or even more than the 240. Just wanted to know your thoughts. Is it that you are going to spend more OPEX in the following quarters, or do you see upside risk to the mid-range of your guidance?
The final question regarding tariffs. If you can tell us what would be your exposure in case the U.S. put, just as an example from newspapers, a 25% tariff on imports. Also, what is your exposure on retaliation if Europe puts tariffs to the U.S., products like Eblas or Ilumetri that you are importing from there? What is your exposure, and what are the mitigating factors you have? Thank you very much.
Okay, good morning. Thank you for your questions. I will leave the question on the line later for Mike. Guidance for the year, I think very pleased with the start of 2025, quarter one, great results. We are in line with the guidance that we gave you a few months ago. I think it's too early today to make additional comments on that. I think we are very comfortable and moving definitely in the right direction. The guidance is very comfortable here. In terms of tariffs, again, we are in a very good place on that regard. Our U.S. business, as you know, is around 5%. We see really marginal impact, if any, regardless of what is the tariff that is finally imposed, if any, again, and if there's any retaliatory tariffs. There will be no impact or very marginal impact from our side either way.
Also, we're in a good place here.
Yeah, and I'll take the gross margin question. Thanks, Jaime. Yes, we had a good gross margin in Q1, even if you take out the outlicensing transaction. We still expect the full year to be slightly down from last year. Last year's gross margin was 64.7%. I would say we probably have a little bit like 20 basis points to 50 basis points of pressure. So still above 64%, but maybe a little bit lower than last year. It'll really depend on the product mix. This Q1, we actually saw a slow allergy season. We saw a slow cough and cold season. The weather's been impacting in Europe a little bit Q1. Having a slow cough and cold season actually helped our gross margin a little bit or those margin products. I don't think it changes drastically our prediction for the full year.
Okay, thank you very much.
Thank you. Once again, as a reminder, if you wish to ask a question, please press star one and one on your telephone. That's star one and one if you wish to ask a question. We will now take the next question from the line of Jaime Escribano from Banco Santander. Please go ahead.
Hi, one final question from my side. On the pipeline, maybe for Karl, the hidradenitis suppurativa looks like a very nice opportunity. Can you dig a little bit deeper on the potential of this new compound, bearing in mind, I don't know, comparison with other peers and size of the market? Any color that you can provide on that opportunity would be great.
Thanks, Jaime. Very happy to provide a little bit of color on that. Hidradenitis suppurativa is a very high medical need indication, so really with a lot of impact on patients' quality of life. There are already certain treatments available, but the benefit so far is rather limited, and there is still a very high medical need in these indications, which is from the prevalence about one fourth of AD. It could become a very significant indication. We are very excited about our anti-IL-1 receptor monoclonal antibody, where we just have completed phase one and plan to start a phase two later this year because it combines mode of action that have been shown individually already activity in these indications. On the one side, the anti-IL-1 beta antibodies have shown some activity, and also the anti-IL-36 antibody has shown some activity.
As our anti-IL-1 receptor antibody inhibits in total six different cytokines of the IL-1, IL-33, and IL-36 isoforms, we believe that this combination has a great potential in this indication.
Thank you, Karl.
Thank you. There are no further questions at this time. I would now like to turn the conference back to Pablo Divasson for closing remarks.
Thank you very much, Sandra. As there are no further questions, ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.