Almirall, S.A.

Good morning to everyone on the call. Thank you for joining us to review Almiral's Q1 2024 financial results and business update. As per usual, you can find the slides to this call on the investor section of our website at almiral.com. Please move to slide number two. I would like to remind you that the information presented in this call contains forward-looking statements which involve known and unknown risks. uncertainties, and other factors that may cause actual results to materially differ. With that, please advance to slide number three. Presenting today, we have Carlos Gallardo, Chairman and Chief Executive Officer, Mike McGillan, Chief Financial Officer, and Kalsi Niravar, Chief Scientific Officer. Carlos will start with the Q1 2024 highlights, as well as an update on our biologic growth drivers as part of our path to leadership in medical departments. Carl will provide you with details on the progress of the pipeline before passing to Mike to review the financials in detail. Carlos will then conclude before opening up for a Q&A session. I would like now to pass it over to Carlos Ayarbo, our chairman and CEO, to commence with the quarterly highlights. Please move to slide number five.

Carlos Ayarbo Thank you, Pablo, and good morning to everyone in the call. Most of you will be familiar with our ambition to become a leader in medical dermatology. We have made significant progress in delivering innovative products to patients with skin conditions to truly impact their lives. And we remain fully dedicated to continue to create impact with our products and support patients and the medical community. 2024 is an important year for us in our progress to achieve our mission. And I'm pleased to report that Q1 was a promising start of this pivotal year for Alvirae. We continue to deliver business momentum based on our key growth drivers, and we are pleased with the trajectory of the growth of our broad portfolio as a foundation to achieve our ambition and business goals. Our key focus this year is on diligently executing the rollout of Eblis and to continue to progress our pipeline that is solely dedicated to medical dermatology. In light of our overall good business performance, we are confirming our full year guidance for 2024. In Q1, the performance of our business continues to be driven by our European dermatology business, underpinned by our recently launched products. We will of course dive into the performance of our portfolio in greater detail during the presentation, but let me touch upon a few highlights already to set the scene. Our biologic for psoriasis, Illumetri, continues to deliver impressive results across various geographies and has become a highly successful product within the medical dermatology market. Since the launch of Winthor and Clayseed in Europe, we have a steadily expanded presence in our market share in medical dermatology in key countries, with notable growth in Spain and Germany. And we have delivered solid rollouts across other European countries where, over the years, we have successfully expanded our footprint. We are also encouraged by the initial metrics of EPBLIS, our biologic for atopic dermatitis, launched in Germany. In Q1, we also made significant advancements in our pipeline. especially in the area of early-stage assets, which will fuel our future growth. Most recently, we announced a license agreement with Elux Pharmaceuticals for a read-through inducer. In February 2024, we successfully licensed the anti-IL-21 monoclonal antibody from Novo Nordisk, and both our anti-IL-1 wrap monochloric antibody and IL-2 mutafluorescein compounds are now in phase one. Please move on to slide seven for an update on biologics growth drivers. Let's take a closer look at the strong momentum of Illumetri, our anti-IL-23 psoriasis biologic in Europe. On the chart, we can see that Illumetri continues to display strong performance with 30% growth in Q1 to 49 million. The class, the NTIR23, also continues to gain market share and maintains its leadership position of new patients among biologics and psoriasis, which helps Illumetri growth, together with a balanced geographical performance. Germany remains a key market, and we continue to see healthy growth in the rest of European markets. New geographic launches are progressing nicely, driving growth further. We also successfully introduced a 200 milligram option without the injector, accompanied by comprehensive new clinical data in 2023, thereby providing additional value. All these factors reinforce our confidence that we are on track to achieve that 250 million pixels. Let me now move to EPCLIS. As we have mentioned in the past, we are convinced that EPCLIS has significant market potential as the best in-class treatment for atopic dermatitis. Its unique mechanism of action and overall strong profile set it apart from other treatment options that are currently available. The initial feedback we're getting from dermatologists and patients is aligned with the results of the clinical trials. The control of disease symptoms. The effectiveness as both a standalone treatment and when combined with topical glucocorticoids and a safety profile suitable for long-term management. All that means that Eblis can offer sustained efficacy and has the potential to significantly enhance the quality of life of treated patients. A particular benefit of Eblis is the four-weekly dosing regime in the maintenance period, which sets its support in the atopic dermatitis market. Also, the autoinjector enables patients to self-administer the treatment to enhance flexibility for patients and healthcare professionals. Let's please move to slide 9 to review the market data. Let me talk some more about the launch of EGIS in Germany and explain to you why we are excited about the progress we are making. Importantly, we are receiving very positive comments from both dermatologists and their patients. which are in line with the insights and data we have obtained in these few months after launch. There is already significant product awareness amongst the healthcare professionals, thanks to the work that our commercial teams have carried out to prepare and execute the launch in the market. This has led to everybody already capturing double digit share of dynamic patients as captured by ICPIA. As most of you know, this captures patients new to brand, both first-time users and switches. This is just after 10 weeks on the market, and it has surpassed all other advanced systemics, except for 2%, at the same point in the launch cycle. We are very pleased with this, and I know this data is only up to February. EPCLIS is also placed second in terms of intention to prescribe amongst first-line advanced therapies for patients with moderate to severe ectopic dermatitis. Again, this is based on the convincing positive results of the Phase III clinical studies and the excellent prelaunch activity. Amongst the initial feedback received from healthcare professionals and patients in Germany, I'd like to highlight three aspects. First, a substantial improvement in patients' quality of life as each inflammation level decreases after the treatment with Eblis. Second, the positive safety profile in line with what was shown in phase 3 clinical trials. Finally, the convenience of the less frequent four-weekly maintenance dosing appears to be playing a crucial role in patients' adherence to treatment. All in all, this positive feedback reinforces our conviction in the potential of Eblis. Next, please change to slide 10 to revisit the rollout plan. We are pleased that we have recently launched in Norway ahead of schedule, and we are on track for a launch in UK, Austria, Denmark, and Spain later this year. The rollout in remaining countries is expected during 2025. As we gain better visibility, we will keep you updated and refining these type notes. We are also very excited that Lilly has refiled their application for the BrichitoMaps market authorization to the FDA in the US. Next, please move to slide 12, where I invite Carl to give an update on our R&D work and the pipeline advances we have made in Q1, as well as giving some details on the excitement agreement we signed with Ellox Pharmaceuticals.

Thank you, Carlos, and good morning to everyone on the call. This slide shows you the progress of our pipeline. We continue to advance both our early and late stage pipeline. For CliSERI, we submitted a supplementary NDA in August 2023, addressing the expansion to large field in the US. We expect launch in the second half of 2024. In addition, he started a study aimed to enable the label expansion to large field in Europe with an expected launch in 2026. For Cysara in China, regulatory review is ongoing and approval is expected in 2024. Regarding the launch process, We recently signed a licensing agreement with a local partner. For efinoconazole, we are under regulatory review. We expect approval in the second half of 2024. The phase one studies for both our anti-IL-1 rep monoclonal antibody and our IL-2 mutin FC fusion protein are ongoing. In February this year, we in-licensed the monoclonal antibody targeting IL-21 from Novo Nordisk. IL-21 is a cytokine hypothesized to be involved in several immune-mediated diseases. We are currently starting to manufacture clinical supply to explore the utility of this mechanism in autoimmune skin diseases. Finally, in March, we in-licensed an oral re-through inducer for the treatment of rare skin diseases from Alox Pharmaceuticals. We plan to start phase one in the coming months. As you can see, we're making very good progress with both early and late stage pipeline and are on track to strengthen our leadership position in medical dermatology. now let's move to slide 14. let me share a few more details on the collaboration with elox zkn013 is a phase 1 ready oral read through inducer designed to overcome nonsense mutation that cause a premature stop codon resulting in non-functional protein production, for example, in recessive dystrophic epidermolysis bullosa, junctional epidermolysis bullosa, and familial adenomatous polyporesis. ZKN013 prevents the disruption of the protein production naturally seen in people with those premature termination codules. Premature termination codon mutations are mutations that, when inserted into a gene of interest, cause the termination of mRNA translation into protein by the ribosome. Thus, the protein synthesized is both truncated and nonfunctional, which causes the disease. Read-through drugs enable skipping such premature termination codon mutation by allowing the cell to ignore the mutation and make the full length protein as it should be. Almiral obtained exclusive global rights to develop and commercialize ZKN013 for the treatment of rare dermatological and other diseases associated with nonsense mutation. We are very excited about having these molecules now being part of our portfolio. With that, I will hand over to Mike for the financial review.

Thank you, Carl, for the exciting overview of our R&D progress and pipeline. As Carlos mentioned, we had a solid performance in Q1 2024, with net sales growth near 7%. We're pleased to show strong growth with our European dermatology portfolio, which is part of our ambition to become a leader in medical dermatology. This helped drive the overall net sales increase. We delivered a total EBITDA of $52.5 million in Q1 2024, up 1.4% from Q1 2023, benefiting from higher sales, offset in part by a slightly lower gross margin percentage and higher investments in SG&A and R&D. Our gross margin came in at 63.5%, impacted by one-off write-off costs, sales mix, and increased royalties related to reaching higher sales levels with Illimetrics. SG&A in Q1 2024 is up 5%, driven by recent and upcoming EBLIS launch investments, partially offset by savings in the U.S. after our resizing in mid-2023. Our R&D investment growth was 10% versus Q1 2023 and reached nearly 11% of net sales with an acceleration expected during the year. We ended Q1 2024 at a net debt-to-EBITDA ratio of 0.6 times, The increase from December was driven by 75 million of payments mainly related to milestones for the EpiVis launch and elementary sales success. Let's move on to the detail of our sales on slide 16. This slide shows our vibrant net sales dynamic. The European dermatology business had another very strong performance with an 18% increase year on year. Our general medicine and OTC business in Europe displayed stable performance with growth across the portfolio more than offsetting the continued decline in FSC Tessavel sales following the patent expiration in late 2022. Our U.S. business recorded a decrease in Q1 2024, which I will detail on the next slide. Rest of the world dermatology sales showed a decline due to the non-repeating of Q1 2023 items such as the Finjuvi out-licensing in Korea and the Cordron tape supply to Japan. The rest of the world general medicine is growing, mainly driven by a rebound in Euminarex sales in Latin America. Overall, it's important to reiterate that our portfolio has limited patent expiry risk going forward, now that we have cleared the main impact from FAC Tessaville patent expiry in late 2022. Let's take a closer look at our dermatology business on the next slide. Our European dermatology segment delivered a very strong performance, primarily bolstered by the growth of Illumetri, with Glycerin and Winsora also adding solid growth, including recent launches in new European markets. Cyclopoli had lower sales in Q1, mainly due to seasonal warding patterns that we expect to normalize in Q2. For the first time, we're reporting the sales of Eblis with 3.6 million, which is a great start to the year. with substantial growth still expected in the coming quarters. Focusing on the U.S. business, CESARA maintained a steady performance in Q1 2024, while Klyceri sales experienced a slight decline partially impacted by a cyber attack on a key U.S. insurance verification system in late February. We still expect to accelerate the growth of Klyceri with the anticipated large field launch in the second half. The U.S. legacy business remains under pressure from ongoing and generic erosion related to Axone and Tesseract. Now let's move on to the complete financial statement. Let's focus on the remainder of the P&L, starting with revisiting some of the items in a little more detail, which were previously mentioned in the financial review highlights. The gross margin declined to 63.5% this quarter as we had some costs associated with inventory write-offs. We also are facing margin pressure in Q1 due to sales mix, as well as reaching higher tiers of royalties for elementary due to strong sales. We still expect the full year gross margin percentage to be close to the 2023 level, as we mentioned in our full year guidance during the February call. R&D expenses are up 10% from Q1 2023, landing at 10.7% of net sales, driven by investment in the pipeline assets. We anticipate this figure to normalize throughout the year, reaching approximately 12% of net sales for the full year. SG&A investments grew in the mid-single digits compared to Q1 2023 and are expected to accelerate throughout the year as we continue the rollout of EBLIS in other countries, while the savings from the U.S. resizing in 2023 will annualize in the second half. Financial expenses have been impacted by the interest income from the short-term deposits, with a 1.3 million impact versus Q1 2023 and lower overall financial expenses. I'd like to remind you that our effective tax rate is affected by the inability to deduct US tax losses against the profitable European business. We expect this to continue for the full year similar to the 2023 results. Please move to the next slide to take a look at the balance sheet. The key point to highlight on the balance sheet is the impact of the recent investments in intangible assets, including a $10 million upfront payment to Novo Nordisk and a minor upfront payment for the Elox Pharmaceutical in-licensing deal, all of which was offset by regular amortization. I'd like to highlight that our net debt ratio remains favorable at 0.6 times, after incurring high levels of cash outflow in Q1, largely associated with the product investments and milestones, which we will see described on the next slide. Let's now take a look at the cash flow stage. We delivered an operating cash flow of $23.4 million in Q1 2024, a significant improvement versus Q1 2023. In 2023, the unusually high working capital impact was primarily attributed to increased inventory related to the growth of Illumetri and the stocking of Plyceri as we took over production from Athenex prior to their bankruptcy. Q1 2024 saw stable inventories and the usual seasonal impact on receivables and payables. Among the investing activities, we had significant cash outflows in Q1 2024, mostly related to milestones for our biologic portfolio. In Q1 2024, we paid a $45 million First commercial sales milestone for EBLIS in the EU. Additionally, we paid a $20 million milestone related to elementary sales reaching higher targets in the full year of 2023. The remaining payments include some additional in-licensing payments related to the Novo Nordisk asset license, ETHERNA and ELOX agreements, as well as a milestone upon the initiation of Phase 1 trial paid to SIMSEER. We expect the milestone payments to decelerate in the rest of the year as we've made the majority of what we're going to make already in Q1 2024. And barring any significant M&A activity, we would expect to have a more normalized outflow in the investments in the last three quarters. The divestment line refers mainly to milestones and royalty collections from the COBUS agreement. With that, let me pass it back to Carlos to conclude the presentation.

Thanks, Mike and Carl. You have seen that we have delivered a good operational performance in Q1 2024, and we remain on track to achieve our full year guidance, which is a crucial step along the way to achieve our ambition in medical dermatology. We have full confidence that Almirai's growth will continue throughout 2024 based on our focus on key growth drivers and the work we do to support our key products. Illumetri has consistently demonstrated strong performance and we anticipate further growth in the year. by the expansion we're experiencing in the Nordics and Eastern Europe. We also expect the positive trends of Glycerin and Winthora to continue as we roll them out across more markets in Europe. Progressing our successful launch of EGLIS in December 2020 in Germany and extending our patient reach further, our commercial teams are preparing launches in other important European countries. Our close partnership with the dermatological community remains vital in our approach to reach more patients and enable them to benefit from our products. And our performance and the feedback we are receiving from the medical community gives us confidence that we are on the right track. Furthermore, we have made significant steps forward progressing our R&D pipeline with exciting new assets entering the early stage and making substantial progress with our late-stage programs. In line with our long-term vision and business ambition, we continue to explore external opportunities for early and mid-stage assets. The collaborations and agreements we enter will always be underpinned by scientific, strategic, and financial rationale to ensure they create impact with patients and the medical community and create value for Amirai on its path to leadership in medical dermatology. With this, we conclude the presentation. Pablo, back to you.

Thank you very much, Carlos. Sharon, back to you for the Q&A.

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. to withdraw your question, please press star 1 and 1 again. We will now go to your first question. One moment, please. And your first question comes from the line of Lucy Codrington from Jefferies. Please go ahead.

Hi there. Thank you for taking my questions. Just to start off, perhaps on a more broader term, There seems to be a lot of focus on some of the recent deals that you've done, that there is a focus now on global rights and launches. I guess for a rare disease in the US, it does seem kind of feasible that that would be possible. But has your attitude changed towards a potential biologics launch in the US? Or should your pipeline be successful for some of those biologics would you consider a partner for us or is that something you foresee you could be launching yourselves you know down the line assuming successful then secondly you mentioned the licensing agreement in China for cesara and what are your thoughts here on the potential of this opportunity and is any kind of success in China appreciating it will only be kind of royalties but is that already factored into the kind of reset of Cesara peak sales that you provided last quarter and then finally on Klyceri it looked a little weak in Europe to me anything to factor in relative to the last quarter for European performance for Klyceri and how we should expect that to evolve during the year Thank you.

Sure. Thank you, Lucy. Thanks for the questions and good morning. Let me take the first question and the third one, and Mike will take the second one. Paolo is over here, so he might be able to add something on some more color about Tricity Europe. But on the recent DLGS, we want, our ambition is to Again, in our ambition to become a leader in medical dermatology, I think we have to be present in the more relevant markets, and this includes the U.S., and eventually beyond Europe and the U.S., so we are aiming always to get global rights. We're very pleased that we've been successful in our last deals to get these global rights. To your question, yes, it's easier to launch a rare disease product in the U.S. than launch a biologic, even the the tremendous commercial effort and investment that you have to do. But the answer is not clear because these products, again, will come to the market in a number of years from now. And let's see how our commercial infrastructure and our robustness is in that market. So it's difficult to answer whether, you know, what's going to be our commercial strategy down the road for a biologic. So we will review the different options and we will make the decision when it comes. But at this stage, we are not giving up any options. In terms of Clay City Europe, I mean, we're quite pleased with the performance of Clay City. And, you know, I think it's very well accepted by physicians, by patients. But perhaps, Paolo... wants to add something a bit more detailed about the product performance. But before going to Paolo, Mike, why don't you take the CESARA question, please?

Yeah, thanks, Lucy. So with the license in CESARA China, we see this as an option. We're not quite sure how big of a product it's going to be, but we're very excited to have a partner in China. We signed this in Q2. You'll see a minor amount of upfront licensing income in Q2 related to this. But that's not part of the revised peak sales we gave was for the U.S. We still expect the U.S. to get between 30 and 40 million. We still need to continue to grow, but we are seeing some decent momentum, especially as we get into Q2 with, let's say, SARS. So overall, the U.S. is still performing according to our expectations. And China, for us, will be a nice option and we'll see how it plays out.

Hello, good morning to everybody. So about Clisiri, as also we have presented, 40% growth in Europe. So year-to-date March 23 versus year-to-date March 24. When we look at our competitive positions, we are, I would say, very happy with our market shares in those countries where we have launched the products. And also we have to consider that basically we are market leaders in many markets, not only with glycerin, but because we own a full portfolio in treating actinic keratosis, also with solar rays, actinic keratosis. So we want to make the market grow because there's a lot of medical needs here. There's a lot of patients that are yet not treated. And we place here, we want to offer patients and doctors new treatments that add on top of our portfolio on actinic keratosis. So happy with the performance so far in Europe.

Thanks very much. Thank you. We will now go to the next question. And your next question comes from the line of Alistair Campbell from Royal Bank of Canada. Please go ahead.

Thanks so much, everyone. I've got three questions. That's okay. First one on Inumetri, a very strong quarter, which is great to see, but now basically annualizing at around 200 million euros, growing at 30%. So it just makes me wonder whether your peak sales target of 250 million euros feels cautious, or is there anything else we should be aware of in the competitive dynamics in the marketplace there? Secondly, on EBLIS and atopic dermatitis, really more a question about the... Apologies.

It looks like we have lost the line. I will go to the next question and wait for him to dial back in. One moment, please. Your next question comes from the line of Thibault Botherin from Morgan Stanley. Please go ahead.

Yes, thank you. First question on the big list in Europe, just wanted to know if you have some market intelligence of what is the penetration today of high-efficacy medicines, so biologics and injection inhibitors for atopic dermatitis in Europe, just to kind of estimate the maturity of the market. Um, just a second question on, on the leadership of the company. Um, Carlos, is there any plan to operate a management transition at some point with an external CEO? Um, or are you committed to the role in the foreseeable future? And then maybe last questions on the royalties, uh, quality payments on products. So can you just confirm that the royalties paid in Q1 were mostly related to limit tree?

and can you give any details on um the royalty rate for these two products in particular fgliss and how we should think about the ramp up of royalty payments in the future sure thank you people i'm not sure i got your question about the maturity of the market uh let me answer what i think you're asking but if not please please feel free to come back to me um there is still the the prevalence of of atopic dermatitis is very high, very high in Europe, you know, between 2% to 4%. And there is still the majority of patients that are eligible for advanced systemics that, of course, is a subset of this total prevalence. You know, the majority are not treated with these advanced systemics. So let's say probably we are treating now or the market is treating now around 10%. So it's a huge market. Patients are severely under-treated, and it's a market that's why we're seeing still a lot of expansion, and we will continue to see expansion, you know, probably until the end of the decade, if not more. In terms of your second question, my plan is to, you know, I'm fully committed to the role, no plans to change, I'm committed in the long term. And I'll go back to Mike, who will take the question about the royalty payments. And again, feel free to come back to me about your first question if I have not addressed it properly.

No, no, it's perfect. I was asking about the penetration rates, and you gave your estimate of 10%, so that's what I was looking for. Okay, great.

Good. Yeah, in terms of royalty, the majority of the royalties we're paying right now are related to Illumetri. Illumetri is already in the in the high teens moving towards the low 20s as we continue to hit higher and higher levels of sales of the product. EBITLIS will have royalties starting in the low teens and then expanding as sales go on, but it'll take a little while before we start hitting some of the upper tranches of the EBITLIS royalties. Overall, they're both going to be products with pretty significant royalties. But that's the case when you have in-license products. They tend to come with a decent amount of royalties on them.

Thank you.

Thank you. We will now go to the next question. One moment, please. And your question comes from the line of Alistair Campbell, Royal Bank of Canada. Please go ahead.

Hi there. Sorry about that. I'll try again. My phone cut out. I don't know if he's been answered or not, but basically my first question was on Illumetri annualizing now at about 200 million euros and growing quite nicely. So just in the context of your peak sales of 250 million euros, is there a sense of caution there? And then maybe just on the EBLIS launch in atopic dermatitis, a sense of what's happening at the market level really in terms of penetration of biologics into the moderate severe space. Broadly, what sort of level is that at? Is that growing quickly, or is it fairly stable? Thank you.

Sure. Thank you, Alistair. So your question about Illumetri, yes, we're very pleased with the growth. The class is gaining market share, and within the class, we are gaining market share. So very pleased with the performance. And yes, it just seems that our pixels are very achievable. But we have not done the exercise yet to review whether we want the pixels and whether we want to revisit our estimate. We might do it sometime down the road this year. Eblis launch. I addressed a little bit the question with Thibault, but I think you were offline. But basically, you know, the penetration of advanced systemics in the eligible population is still very low, probably not even reaching double-digit penetration. So there's tremendous opportunity for market expansion. Yes, we are seeing a little bit of that. We're seeing how the market growth has accelerated versus last year. And probably that means that the penetration in the eligible population also is increasing and it's moving and it's increasing. And Paolo, maybe you can add a little bit more color to that.

Yes, absolutely. So just to mention a number, in between 2022 and 2023, the market has grown in terms of patients 37%, beating the growth in 2021 and 2022 that was 31%. And basically, 90% of this market is driven by naive patients getting into new treatment. That means basically that what Carlo was saying, only 10% of the patients suffering from moderate to severe atopic dermatitis are treated yet with biologics. So there's an enormous space available for new biologics. Thank you.

Thank you. We'll now take the next question. And your next question comes from the line of Jamie Esquibano from Banco Santander. Please go ahead.

Hi. Good morning. So my first question on EFGLIS would be, I assume you have not provided the units per month because you only have... but my question would be if we could see March, April evolution, what is what you are envisioning for Q2 in terms of the ramp up in new prescriptions? Also, if you can give us the breakdown or more or less on how much of the growth is coming from new patients and how much is from switches, I think that would be interesting. To have, and then a question on the milestones for following years and this year. So if you can give us a figure for modeling and in the gross margin, you said that it was coming below due to one-offs. Could you quantify that one-off and just elaborate a bit more on how is this going to recover along the year? Thank you very much.

Thank you, Jaime. On EGLI's uptake, what we can say is that we are very pleased with the strong start, but realize that we only have two data points of market dynamics data, you know, because there's always a delay between what's happening in the market and when IGVIA gives us the data that typically is around six, seven weeks delay. Okay, so I think it's too early for us to get into predictions or getting into figures for the full year. Okay. I wouldn't read that into whether it's positive or negative. It's just that we want to be prudent. Okay. But I would say we're reiterating that we are very pleased with the strong start. In terms of the breakdown of what we're seeing in these two first, with these two data points, maybe Paolo can mention, but I can advance you that the majority is first-line patients, and that's what we want to see, because this market is driven by first-line patients, right, Paolo?

Exactly, and I can add that with two data points, basically what we see is that there's patients, of course, that they don't have any alternatives, no, because they have been treated with 2P or maybe others, JAKs, still with a lot of, let's say, concern. So that's why there's also a little bit of switches. But our strategy is clear. We want to be first line therapy, and the naive market is the one that drives this growth.

Yeah, so in terms of milestones, we had roughly 80 million in the first quarter. I think the full year target should be roughly 120, plus or minus a little bit, in absence of doing any kind of new acquisitions. You know, if we do some kind of product acquisition before the end of the year, that could be on top of that. But basically, those milestones are related to mainly elementary and EBLIS and then the few deals that we've done and a few other things that we're planning to do. Going forward, I would say that would regulate down a little bit because we'll get into a phase where we're paying a little bit less milestones until we get to some higher sales level of EBLIS down the line, which is probably more 26, 27 in terms of the years. In terms of the gross margin, the one-off was a little bit less than $2 million of some write-offs that we had for some excess inventory, mainly related to our supply business for products that are not necessarily in our promotional grid, but that we supply to other companies. That will normalize over the full year, but But $2 million in a first quarter can give us almost a percent of gross margin difference. So we still expect to get close to the $65 million that we had last year and this year.

Okay. Thank you very much. Thank you. We'll now go to the next question. And your next question comes from the line of Gilomei. Sampaio from CaixaBank, please go ahead.

Hello, good morning. Thank you for taking my question. So two, if I might. The first one, if you could provide a bit more granularity on the timing of the new country launches of Leverkusen Map during 2024, what will be in Q3 and in Q4. And secondly, In terms of OPEX phasing, so you've alluded to some step ups throughout the year. Should we see this already in Q2, or is it going to be more driven towards the second half of the year? Thank you.

Paolo, you want to take the first one, please?

Yes. So as Paolo has mentioned, you can find it also in the presentation. Next launches this year will be UK. Austria, Denmark, and Spain for Abilis. All the rest of the countries will be launching in 2025.

And in terms of the OPEX phasing, I think we'll ramp up more in the second half. We're benefiting in the first half from still some of the savings we did in the U.S. Last year in the U.S., we resized in July. So we have a significantly lower cost base. in the first two quarters in the US versus last year. That will annualize in the second half. And in addition, we're seeing, of course, the ramp up of the EPLIS investment as more countries come online with their launches.

OK, thank you. Could you give me more detail on the launches for 2024? Which ones will be in Q3, which ones in Q4?

We expect UK in the month of maybe June, July. Austria, Denmark, and Spain will be more at the end of Q3, beginning of Q4.

Okay, thank you very much.

You're welcome.

Thank you. We have one further question. One moment, please. And your question comes from the line of Alvaro Lenz from Alantra Equities. Please go ahead.

Hi, thanks for taking my question. Just if you could provide some maybe mid-term guidance considering the royalty level of your current portfolio on what could normalised gross margin be, is that 65%? going to trend upwards as the leverage ramps up, or should it be stable considering the realities that it's going to be? And my second question will be on M&A. Over the last few quarters, you have announced small R&D deals, mostly focused on early stage drugs. Would you be considering incorporating maybe someone a bit more developed, maybe phase two or approaching phase three, or are you continuing Are you going to continue to focus on very early stage products? Thank you.

Thank you, Alvaro. I'll take your second question and then I'll pass it to Mike for the first question. So M&A, very pleased with the deals we've been making to fill our early stage pipeline. Very consistent also with the guidance we sent a number of months ago when we did the capital increase. Yes, we would love to get also assets in later stages of clinical development, and we are actively looking into that space as well. But again, it's not that there are many assets, and it's a very competitive space as well, so just keep in mind that. So maybe we can bring something, you know, we can make a deal about with these assets, and we will continue also to look at earlier stages.

Yes, in terms of the gross margin, so, you know, we've given some guidance for this year of being close to the 65 of last year. I think we need to look in the longer term that given where we're seeing price levels potentially come in for EBLIS, given the royalties, and also given the stepping up of royalties of elementary, we're more likely to see flat to even some downward pressure on the gross margin percentage than we're going to see expansion. But that's not really our investment thesis. Our investment thesis is rapid sales growth, allowing us then to delever the SG&A so that we can expand the margin at the bottom. So we're not going to get it necessarily from growth margin percentage, but we're going to get margin expansion in the coming years for being able to grow sales much more rapidly than we grow the expenses once we've gotten the infrastructure in place this year and next year for EBLIS in Europe. Basically, you know, I think we will see a little bit of pressure on the gross margin just because of the high royalties that come with licensed products. But we will be able to expand margins in the coming years because we'll be able to grow sales much more rapidly than the SG&A expenses.

Maybe a follow-up then, if you could provide, you know, it's maybe early, but maybe that 25% to 25% to 30% of the margin that you used to have is achievable again.

I think definitely 25. We'll have to see how the products develop before we can start talking about 30 because, you know, we have to admit that in that 30, we did have some income related to the trailing divestment of the respiratory business that helped prop that a little bit. So definitely we want to get to 25 pretty rapidly in the next couple years. Now where we can then top out will really depend on how the portfolio develops.

Perfect. That's very helpful. Thank you very much.

Thank you. There are currently no further questions. I will hand the call back to Pablo.

Thank you very much, Sharon. We are now going to close our Q&A session. And with this, we will conclude our conference today. We want to thank you for your participation. You may now disconnect.