Hello, I'm Shan Hama from the European Pharma and Biotech team at Jefferies. Welcome to the Jefferies New York Healthcare Conference, Day One. I'm happy to be joined by Carlos Gallardo from Almirall. Firstly, let's just start off with an introduction to Almirall. Thank you, Shan, for having us, and thank you to Jefferies. It's a pleasure to be here today. Almirall is a biopharmaceutical, European-based company focused on dermatology exclusively. We have capabilities across the continuum of the value chain, from early research all the way to commercialization, EUR 1 billion in sales with double-digit growth, and with a focus on, as I said before, exclusively on dermatology. Why dermatology? It's already a very big market, around EUR 50 billion in sales, with a nice growth. We see tremendous opportunity to develop new therapies, as there are many diseases that have suboptimal therapies in place. Great opportunity to be here. Today, the market is being driven by two areas: psoriasis and atopic dermatitis. This is where we have our two biologics, Ilumetri for psoriasis and Ebglyss for atopic dermatitis. We have a tremendous opportunity in front of us, as we expect peak sales of both products combined in Europe above EUR 800 million in peak sales. Truly a transformational opportunity for us, and we are completely focused on execution. In addition to that, we are also focusing on the second opportunity of value creation for the company. That is in developing the next generation of innovative therapeutics in dermatology, where we have a rich and diverse pipeline and in very exciting diseases. Brilliant. Thank you so much for that. Let's start off with one of your key growth drivers. You mentioned Ebglyss, which is approved in atopic dermatitis in both Europe and the U.S.. Focusing on Europe, how's the launch progressing versus internal expectations? What's the feedback been from physicians and patients? So far, it's going very well. As per expectations, or even ahead of expectations in some areas, let me break it in different chapters. From what we've seen from the different health systems in Europe, there's been an eagerness to adopt Ebglyss as a treatment for patients for moderate to severe atopic dermatitis, as health systems wanted a credible alternative to Dupixent. That has really favored our negotiations in terms of both securing reimbursement, but also securing a relatively good price for us. In addition to that, once launched in the different markets, we've seen very good, very positive feedback from physicians using the product. Very consistent feedback as well across different types of patients. Atopic dermatitis is a very heterogeneous disease with different types of symptomology and different types of phenotypes of the patients. We are seeing, and that's supported by our data, very strong efficacy in the different types of patients. This is what we're hearing now from physicians. I would say that overall, in terms of price and negotiations, market access, feedback from physicians, and ultimately the adoption, the usage of the product is very aligned with our expectations and going exactly according to plan. Brilliant. What's the current mix of patients using Ebglyss so far in terms of naive and switch? How do you expect that to evolve in the longer term? We believe that Ebglyss is the best product to treat moderate to severe atopic dermatitis patients. Therefore, that's our message, and the data supports that, and that's our message to physicians. We are really positioning the product for first-line use. We are already seeing a majority of patients that are first-line. Of course, the product is being used in second-line as well, in failures from other advanced treatments, as expected. Already today, the majority of patients come from first-line, which is great and very aligned with the data we have and with our messaging. Brilliant. Just on that, Dupixent's currently the sort of incumbent biologic for atopic dermatitis. Almirall studied Ebglyss in Dupixent refractory patients. Could you outline some of the results seen here and how the study is important in driving uptake, particularly in that first-line setting? As I mentioned before, we are seeing very consistent results in all types of patients, including patients that have failed in other therapies or have other experience in other therapies, such as Dupixent. The results that we're seeing in patients' experience in Dupixent is very similar to what we're seeing in other types of patients, including naive patients. Okay. Your peak sales for Ebglyss was updated. It was now over EUR 450 million. What would prompt a reevaluation of this peak sales, as it's been sort of sat here for quite a while? How should we think about the sort of ramp to that peak sales as well? We are launching, so we launched within two years in Germany already. That is where we have more experience and where we can see a more consistent ramp-up. In other countries, we have just launched. For example, in France, we launched last month. In Italy, we launched also a few months ago. In these countries, in some countries such as Italy, we are still going through the market access as we need to get the product in the different regional formularies, for example, right? Whilst we have good data in Germany, we still do not have clear, predictable data in other countries. I think we need to wait a bit more to see how things pan out in other countries, so we can see whether, when, if and when we revise our peak sales estimate for Ebglyss. Understood. Makes sense. So, Ebglyss is currently approved for use in 12 years and older, if I'm not mistaken. But your partner, Eli Lilly, is investigating Ebglyss in pediatric patients in a phase three study. When should we expect the 16-week data? And is this indication included in the peak sales? First, thank you for bringing it up. I would like to highlight the great partnership that we have with Eli Lilly and truly synergistic, particularly in the data generation. As you know, we are both leading some of the studies. They are leading some of the studies, and of course, we can capitalize on each other's work. The study that you mentioned will read out next year, and we will be able to use it in Europe, of course. To your question, the peak sales estimate, yes, it does include the label expansion to capture this patient population. Okay, brilliant. Now moving on to your other key growth driver, which you mentioned, Ilumetri in psoriasis. At the start of the year, you raised the peak sales from EUR 250 million to EUR 300 million, despite potential increasing pressure from biosimilars in Europe. What drove this upgrade, and how should we expect growth to evolve this year versus last year? First, we're seeing that the market continues to grow double-digit, as there are still, although it could seem that it's kind of a mature market because there are a number of competitors and different classes in it. If we look at the data, we see that only 20% of patients that are eligible for such advanced treatments are in these advanced treatments. There's still a tremendous opportunity for market growth and market expansion. Within this framework or background, the winning class or the preferred class in Europe by dermatologists are the anti-IL-23. That's where Ilumetri sits. It's an IL-23. Within this class, we have already captured 20% of market share of the anti-IL-23 class, and we continue to gain market share. This is driven by the great commercial execution of our teams. Also, we have recently launched the 200 mg presentation. First, we had launched the 100 mg, and this at the same price. This provides additional flexibility for the prescriber, for the dermatologist, to treat their patients and achieve their desired goals, treatment goals. When they have a patient that, because has a higher burden of disease, or because the patient might be overweight and needs more dose, they can seamlessly transition the patient from the 100 mg to the 200 mg. They were providing this additional flexibility that has been highly well received by dermatologists across Europe. This unique value proposition really is helping us to continue to gain market share within the anti-IL-23 class. Okay, that makes sense. Illumetri is also in a phase three study for psoriatic arthritis, with data expected during the second half of this year. Could you outline the current treatment paradigm for this condition and then the opportunity here for Almirall? We believe that PSA indication can add to the body of evidence to support first-line use of Ilumetri, not only in psoriasis patients, but also in PSA patients. We believe that it will be a nice addition to Ilumetri if the phase three is successful. Now these patients are treated with a number of products, including anti-IL-17s, anti-IL-23s, and we hope that soon we'll get license as well for Ilumetri. Sounds good. We await that. Sticking with the psoriasis portfolio, could you outline how Wynzora sits within the treatment paradigm and how launch is progressing in Europe? Wynzora is a topical agent licensed for psoriasis patients. It's growing very nicely. Quarter one continued to grow double-digit, I think around 25% growth. I would highlight the patient convenience of the formulation for patients. It's patients that try the product, and they go back to the physician and say, "Look, that's what I want." We believe it's a very nice addition to the different tools that dermatologists have to treat psoriasis. What's the sort of peak sales potential of this product? I don't know if you've previously disclosed. We are not disclosing the Pixel's potential. We have not singled it out yet. Okay. Again, we believe that has a very nice growth potential. Okay, makes sense. Then moving on to Klisyri in actinic keratosis. Last August, you launched for large field use of the product in the U.S.. Are you seeing any challenges to uptake in the U.S.? Is there any cannibalization on small field? We think that the large field is mainly additive to the small field, as we had expected. That is good news, as it is confirming our assumptions. There are a number of treatments for actinic keratosis licensed both in the U.S. and in Europe. Some of those, or many of those, have generic versions. It is a highly genericized market. Of course, what we are seeing is more very nice adoption and feedback from prescribers. Where we see a bit more pushback is from payers, as they are biased towards pushing first generic versions. We are seeing step edits and prior authorizations, in some cases, for the use of Klisyri. We have a strong team that is working on trying to remove those barriers from prescribers. Okay. And then how should we be thinking about the sales trajectory for Klisyri throughout the remainder of the year? We believe that the strong growth of the Klisyri franchise will continue going forward. You anticipate European launch for large field in 2026. How do the market dynamics differ between Europe and the US for the treatment of actinic keratosis, if at all? It does differ. In the U.S., there's high use of cryotherapy, and in Europe, less so, as in the U.S., physicians get reimbursed for procedures, whilst in the majority of countries in Europe, there's no such reimbursement. The dynamics of incentives for physicians are a bit less, and they are more used to use topical products. In general, there's more use and more adoption of topical products in Europe than in the U.S. because of this cryotherapy consideration. Okay. Now moving on to your mature portfolio, how should we be thinking about erosion for the remainder of the year? We have a material portfolio that is extremely stable, has been stable already for a number of years, and for the foreseeable future until the end of the decade, we also foresee a very stable mature portfolio that is highly profitable. I think that is great for us because having this mature portfolio and profitable gives us the stability to then invest adequately in the growth drivers, such as Ilumetri, Ebglyss, Klisyri, and Wynzora. I think we are in a very good position here. Brilliant. Sounds good. Let's move on to financials. Consensus seems to be aligned with the 2025 net sales guidance. Do you see upside given your good performance to date? Maybe just touch on the key pushes and pulls to the P&L. We recently provided medium-term guidance, and we said that we expect double-digit growth in the top-line sales from now until the end of the decade, mainly driven by the two biologics in Europe. Also, thanks to the operational leverage, we have already done all the necessary investments we needed to be done to maximize the sales of these two products. What we're seeing is operational leverage that will increase our EBITDA margin from the current 20% to 25% in 2028, and hopefully beyond 25% beyond 2028. That is to provide the mid-term framework. With this, for this year, we have provided a guidance of top-line growth between 11% and 13%. So far, Quarter One has been very aligned with this guidance. We were encouraged, again, by the early results of the year, and we are happy to reiterate this guidance. Whether we can beat it or not, we will see. Of course, we are aiming towards making sure we can maximize the introduction of our brands. Makes sense. You spoke to that EBITDA margin in the mid-term of 2028 of 25%. How do you expect to achieve this margin expansion while still ensuring that you're achieving a healthy level of investment in Ebglyss, given its country-by-country launches? Sure. As I said before, over the last two, three years, we have invested significantly in terms of increasing capabilities, expanding our field forces in training and a number of areas to make sure we had the right infrastructure, capabilities, and people to maximize the sales of these two brands and the introduction of these two brands. We do not think that adding to this investment will be beneficial for the brands because we think we are at the optimal level now. Now, what we are going to see going forward and already starting this year is operational leverage. We are going to see double-digit growth top-line. R&D is going to remain constant at around 12.5% of sales. This will remain constant. SG&A will remain constant on an absolute number, maybe with some adjustment for inflation. Therefore, all this delta is operational leverage that will go straight to the bottom line. This is how we will achieve this margin expansion from 20% to at least 25% in 2028. Okay, very clear. Now for the topic that's been on the mind of many, many investors. Could you highlight how Almirall is potentially a safe haven for investors in the healthcare space in light of the recent sort of most favored nation pricing announcement and the U.S. potential pharma tariffs? The U.S. represents today only 5% of our sales and a smaller percentage of our EBITDA margin in terms of percentage. Most of our brands are manufactured and distributed in Europe. Therefore, we are very isolated for any potential tariff that could be imposed by the U.S. administration or reciprocal tariffs that could come from the European authorities. I think we will have no impact for us, which is great. We can focus on really executing on our plans. Sounds good. Then moving on to business development, what are Almirall's priorities here, both in terms of therapeutic area and then also geography? Sure. Let me reiterate that the opportunity for value creation that we have in the short term is by organic growth through our growth drivers, and of course, by making sure that we deliver on the new treatments that we are developing in our pipeline. We have four proof of concepts, so four programs that for the first time will move into patients. Extremely exciting from our side. We also have to make sure that we deliver flawlessly on these four proof of concepts. That is what our attention is: organic growth, organic execution, and delivering on the four POCs. Having said so, I say that because we do not want to go through a kind of transformational M&A opportunity because we do not want to distract the teams from this tremendous growth opportunity or value creation opportunity that we have in front of us. Having said so, we have the BD teams that are strong, that have a very good track record, that continue to look for attractive licensing opportunities, and maybe some commercial bolt-on opportunities that will not be a distraction that we can nicely plug into existing infrastructure. We are particularly looking for, of course, always in dermatology, areas that could be a nice bolt-on either in Europe or in the U.S. with a particular interest for products in rare disease. Okay, interesting. Obviously, you said you're very focused on your sort of current pipeline, current portfolio. Would a sort of late-stage acquisition or commercial-stage acquisition, is that something that could be in Almirall's future? Yes, absolutely. As I said before, we have a business development team with a very good track record in licensing, and that is part of our business model to complement our internal research. We remain very active in scanning the market, and we have, I would say, a nice pipeline of opportunities that we hope we can translate into licensing deals sometime in the next few months. Yes, we remain, of course, very interested in licensing opportunities. Yeah. Could you speak to perhaps the competitive environment or the M&A environment for dermatology assets? Sort of what's that like at the moment, especially given current market volatility? It is a very competitive area. Whilst we have been in dermatology for a number of years now, there are some companies in which dermatology was not on the radar screen, but because they were already developing drugs in immunology, the immunology has taken them to dermatology, as there are many immuno-mediated diseases within dermatology. It is an area now that is very hot, and we see both big and small companies interested in acquiring companies, but also in licensing assets for immunology targets, including immunodermatology-mediated diseases. It remains competitive. Yeah. You now have a much larger innovative pipeline than you've basically ever had before with assets in, for example, hidradenitis suppurativa and some rarer skin conditions as well. Does this give us an indication of where Almirall is headed in the mid-term, sort of in terms of being a more R&D-driven company? Yeah. What we've done, we've been exclusively focused on medical dermatology now for 10 years with capabilities across the continuum of the value chain from early research to commercialization. I believe that we are now the only company that has these capabilities, and that is exclusively focused on dermatology. We have recently, a number of years ago, decided to double down on internal capabilities for research. In particular, into areas. One, we want to be very close to the dermatology community, to the dermatologists, to understand where the unmet need is on one hand, and on the other, have a very strong disease biology group. We can put both things together: where the unmet need is, where patients are suffering and need additional treatments, and then go back to our disease biology group and say, "Okay, which are the scientific hypotheses that we can develop with a correct understanding of the diseases so we can create novel programs to put into our pipeline?" We call ourselves modality agnostic. Then we choose, "Okay, what's the best way to deliver this new treatment?" Whether it's a small molecule, it's a biologic, it's through mRNA, etc. We are building very strong partnerships with different technology providers that can help us bring their capabilities to make sure we are able to push these technologies and these programs towards commercialization. Yes, I believe that we are now on the cutting edge of science. We consider ourselves scientific leaders already in dermatology, and we are very proud also by the partnership that we have put in place with the different technology providers. Great. Could you actually speak a bit more about that hidradenitis suppurativa asset? That is one. It is an indication that has been sort of very, very hot recently, especially given assets like Cosentyx and Bimzelx. Could you speak a bit more about your own asset? Sure. This is referring to the Anti-IL-1 RAP program that has effect on different parts of the immune system, including IL-1, IL-33, and IL-36. We've seen already evidence in the clinic by other programs, other products developed by other companies, that IL-36 and IL-1 has an effect on hidradenitis suppurativa. We believe, and that's our scientific hypothesis, that by having one product that has a role in the inhibition of different cytokines, we will have an additive effect. Therefore, we have a very attractive value proposition in our hands. We are moving this program now into patients. In the next few months, we will be dosing the first patients. That's very exciting, hopefully before the end of the year. We believe that HS or hidradenitis suppurativa is an area still with tremendous unmet need, and we believe that our program has a potential to be a best in class. Brilliant. Not only best in class, but I would say best in treatment. Okay. We agree away that. Are there any other pipeline assets that you wish to highlight? Of the products that we'll be entering, proof of concept within the next few months, we also have an anti-IL-2. This one is also very exciting because it has an effect on T regulatory cells. We believe that this product has the potential to restore the homeostasis of the immune system. This has applications not only in dermatology indications, but even beyond dermatology. It is one of these products that could be a pipeline in a drug, so to speak. We are developing this product with the originator, with Simcere, a Chinese company. They are also trying POCs. They will be doing POCs in different indications than us, and then we can mutually benefit from our efforts. That is another very exciting asset that we have in our hands. We have an anti-IL-21 that we are going to put in also in patients with immuno-mediated diseases. We are not yet disclosing what is the first indication, but also we have very good hypotheses on where it could work. Lastly, we have another product for a read-through inducer for a rare disease, epidermolysis bullosa. That is our first product that we have for a rare disease as well, and it is completing phase one. We will be moving to phase two to patients as well. There is an area that, although there have been recently approved new medications, and that is great for patients, there is still a lot of unmet need remaining. We believe that this product, being an oral, could also fill this need. Lots to look forward to in the future. Do you have any sort of things you want to highlight that maybe we haven't spoken about or any closing remarks? I think that we're in a very good place as a company because we have a transformational opportunity in front of us. First, to grow the company with this double-digit ambition until the end of the decade that we have in front of us, that will allow us not only to be bigger, but also to do more in research and to develop these exciting innovations that we have in our pipeline. Two tremendous opportunities of value creation, one through executing through commercial execution to maximize the penetration of Ebglyss and Ilumetri, and then another opportunity to create a lot of value for the company by developing the next wave of innovation in dermatology. Very exciting times for Almirall. Definitely. That brings us to time. Thank you so much for joining us, Carlos. Thank you very much, Shan. It's been a pleasure.