11/11/2025

speaker
Nadia
Conference Operator

Good day and thank you for standing by. Welcome to the Almiral 9-month 2025 Financial Results and Business Update conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star, 1, 1 on your telephone keypad. You will not hear an automated message advising your hand is raised. To withdraw a question, please press star, 1, and 1 again. Please be advised that today's conference has been recorded. I would now like to hand the conference over to our first speaker today, Pablo Divasson, Head of IR. Please go ahead, sir.

speaker
Pablo Divasson
Head of Investor Relations

Thank you very much, Nadia, and good morning, everyone. Thank you for joining us for today's quarterly earnings update and review of Almiral's nine-month balance of results of 2025. As always, we are sharing the slides we are using today in the investor section of our website at almiral.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, we have Carlos Ayala, Chairman and Chief Executive Officer. John Garay, Chief Financial Officer, and Carl Sigalán, Chief Scientific Officer. Carlos will start with the business highlights covering the first nine months of 2025, followed by an update specifically on biologics and the key growth drivers of our medical dermatology platform. Carl will provide you with an R&D status update presenting our pilot. We then talk to you through the financial before Carlos concludes the presentation, and we open for questions. I will now hand over to Carlos Gallego, our chairman and CEO. Please, move to the number five.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Carlos Gallego- Thank you, Pablo, and good morning to everyone on the call. Amirai delivered strong year-to-year-to-date results in 2025, and we are confident to reiterate our guidance, meet the outlook, and fix expectations. Our consistent growth is powered by the success of our medical dermatology portfolio, but we continue to deliver innovative treatments and broaden access for patients to support our physician community. EPLIS delivers strong momentum in the third quarter of 2025, as European markets start to scale, with launches now completed in the key countries. Encouraging upticks in newly launched geographies reinforces our confidence in the product's positioning and growth potential. E-lumetri continues to deliver steady year-on-year growth, keeping us on track to achieve peak sales of over 300 million. With Thora now capturing leading market chain in tea countries, together with Caixiri's strong performance across Europe, are two other important contributors to our European remedy base. This underscores the breadth of our Dermatology portfolio and RBI's position as a comprehensive provider, one-stop shop for diverse dermatological needs. We've built our strong presence in the medical dermatology field throughout the year. In addition to participating in major events, such as the 2025 annual AAB meeting, we reinforced our presence at the 2025 European Academy of Dermatology and Venerology Congress in Paris. Our contributions include 44 scientific abstracts two expert-led symposia, and the presentation of two-year positive study data on Illumetri as a late-breaking abstract. On the clinical side, we are excited to share that the anti-IL-1 RAP antibody has entered Phase II for intrathelitis superlative. We also plan to start Phase II studies in the upcoming months for the other proof-of-concept acids. CAR will soon provide a full update on the recent developments in our pipeline. Please move on to slide 7 for an update on our biologics portfolio. In the first nine months of 2025, Illumetri generated $171 billion in net sales, marking a steady 12% growth year-on-year. We remain on track to achieve over $300 million in peak net sales, even as the product and the class start to reach a more mature stage in its growth curve. Pneumetri continues to be well positioned in the psoriasis market, keeping its market share and consolidating its position as a leading prologue within the leading anti-ALT entity class. The successful launch of the 200mg formulation provides greater dose inflexibility for patients, enhancing its competitive positioning and supporting long-term growth. In addition, two-year positive study data presented at the 2025 EADB highlights that followed long-term value and the overall impact on patient well-being. Please move on to the next slide on Eclipse highlights. We view Eclipse as one of the most successful atopic dermatitis launches in recent years, since we gained approval in Germany in December 2023. It has quickly become our second best-selling product. Meanwhile, the advanced therapy segment within the atopic dermatitis market in EU5 continues to expand rapidly, growing at an annual rate of around 30 percent. Sales for the first nine months of the year nearly quadrupled year-on-year to 75.5 million, while QC sales reached 31 million. Our focus execution has delivered solid quarterly growth momentum as European markets are scaling at a healthy pace following launches in most countries, with Portugal and Ireland undergoing negotiations. Encouraging early fractional market share uptake are evident across Europe's geographies, building confidence in EFTI's growth trajectory and positioning it as a key driver for future expansion. It is important to note that could reimburse reflects the higher net need in atopic dermatitis and the value healthcare systems place on innovation. We are continuing to expand and increase brand awareness across multiple markets within the first year, with which we are very pleased. In terms of clinical advancements, our collaboration with Lilly remains highly productive, fostering valuable knowledge exchange that drives on-going market development. At EADB 2025, we presented numerous study results on Levitizumab, reinforcing our commitment to advancing care in a complete manner. This included newly-enrolled evidence from the AD LIFE study, long-term extension data up to three years, patient-reported outcomes, and safety analysis. Collectively, these results highlight rapid symptom relief for sustained efficacy, further the differentiated profile. Let me turn it over to Karl for an update on our .

speaker
Carl Sigalán
Chief Scientific Officer

Thank you, Carlos, and good morning to everyone on the call. This slide shows you the status of our pipeline. Let me focus on the progress we made in the last month. We expect approval of cell recycling in China until this year. Together with our partners, Sun Pharma and Eli Lilly, we continue to work on expanding the labels for our key products, Illumetri and FGLF, respectively. Our partner, Sun Pharma, announced in July the top-line results of two phrase C studies to assess the efficacy and safety of tilgaclizumab in patients suffering from psoriatic arthritis. Both trials met their primary endpoint at week 24 and are still ongoing for additional 28 weeks until completing the open-label extension. We keep you updated for next steps. Our partner, Eli Lilly, has recently published data from an additional 32-week extension of the Phase III, a joint trial, at the 2025 Fall Clinical Dermatology Conference. That indicates that lepregizumab, the same similar levels of skin clearance, when administered as a single injection of 250 milligrams once every eight weeks, compared once every four weeks. This supports a potential less frequent maintenance dosing in patients with moderate to severe atopic dermatitis. These data proven efficacy and demonstrate the potential for disease control with even less frequent doses. Lilly has admitted these data from the joint extension trial among other data to the FDA for a potential label up. As the regulatory and market access environment is different in Europe, we will stick to our label with a recommended 250 mg labricizumab for weekly pathology. At the same time, we are investigating labricizumab maintenance dosing of 500 mg administered once every 12 weeks as part of our AshO2 clinical trial. Together with our partner, Eli Lilly, we are running joint clinical development programs to make labragizumab available to additional patient populations. The different programs are well on track, and a daytime overview can be found in the appendix. an exciting early clinical pipeline, addressing novel mechanisms and best-in-class compounds in high-medical-kidney disease. In the coming 9 to 12 months, we plan to have initiated four groups of concepts-based two clinical studies across a spectrum of different dermatological diseases. Let me highlight some of the problems. For our antibody called LAV-191, we have completed phase one single and multiple sending doses in . We have also explored pharmacokinetics, pharmacodynamics, and safety in patients suffering from and presented those data at the EADV meeting in September this year. LAV-191 was well-tolerated. and demonstrated a favorable safety and decay profile in patients with hidradenitis superativa. LAD-191 showed a transient decrease in neutrophils count. Furthermore, it led to downstream cytokine reduction and early signs of clinical improvement in HS lesion count. A Phase II study to explore the efficacy of multiple dosing regimens of LAD-191 compared to placebo in participants with moderate to severe hyperadenitis supra-tiva testing starts. Together with our partner, Synseal, we are developing a so-called IL-2 mutinous diffusion protein to stimulate regulatory T cells as a novel approach to treat autoimmune skin disease. We have recently completed phase one, and plan to start a Phase II study in alopecia areata within the next month. Our partners in SEER have initiated a Phase II study to evaluate the efficacy and safety of this altimutant FC fusion protein in subjects with moderate to severe atopic dermatitis. In summary, we're making good progress with both our early and late-stage pipeline projects. With that, I will hand over to John for the financial report.

speaker
John Garay
Chief Financial Officer

Thank you, Carl, for the update on our R&D pipeline, and good morning, everyone. As Carlos highlighted earlier, companies' consistent execution continues to achieve solid, tangible results. In the first nine months of 2025, Almiral delivered a strong performance, with net sales growing nearly 13% year-on-year on track with companies' full-year guidance. European dermatology portfolio remains the key growth driver in Excel, reinforcing Admiral's path towards leadership in medical dermatology. Gross margin moderated to 64.9% of sales in the first nine months, reflecting ongoing pressure related to Illumetri royalties. EBITDA for the period reached 180.7 million euros marking a 27% increase versus the same period last year, driven primarily by robust top-line growth and a lower SG&A over net sales ratio. SG&A increased 6.2% to €356.7 million, with a mentioned lower growth in the third quarter. However, as with previous years, we do expect a certain pickup in expenditure in the final quarter. R&D spending increased by about 14% year-on-year, representing 12.5% of net sales. The ratio of spending relative to net sales moderated this quarter, following higher investment in Q2, keeping us on track with our annual target. We closed September with a net debt to EBITDA ratio of 0.1 after solid cash generation in the quarter. Our low leverage provides significant flexibility to pursue licensing opportunities and targets both on acquisitions and on opportunistic basis. These results reinforce our confidence in delivering full year 2025 guidance and the mid-term outlook shared earlier this year. For the full year, we expect to land near the mid-point of our guidance range for both net sales and EBITDA. Please keep in mind the tough comparison against June 4, 2020, for revenue, when companies reported sales growth of 19%. In addition, as mentioned earlier, we expect a pickup in SG&A in the next quarter, which simply reflects natural facing of quarterly costs and sales trends. As a reminder, our 2025 guidance calls for net sales growth of 10% to 13%, and a beta in the range of 220 to 240 million euros. Let's move to the details of our sales breakdown on the next slide. The European Dermatology Business delivered a stock performance with net sales growing 24.5% year-on-year in the first nine months. Additional details will be shared on the next slide. In general medicine and OTC, European sales were mainly impacted by the recent divestment of Alkidot and the auto-licensing of CECIS. Excluding these portfolio changes, the segment remained broadly stable. A delayed allergy season in Avastel, continued erosion of the disease test habit, and lower sales of minor products were largely offset by a solid contribution from AMMAX. On out-licensing, we expect full-year income to remain broadly consistent with 2024 and prior years, as these transactions are part of our ongoing strategy to maximize portfolio including the bills mentioned earlier. Performance in the U.S. declined, and further details will be shared on the next slide. In the rest of the world, general medicine remained broadly stable, while dermatology saw a slight decline. Let's take a closer look at the dermatology business on the next slide. Our European dermatology business continued to prosper. Illuminati exhibited its characteristic summer seasonality with flat quarter-on-quarter sales and healthy year-on-year growth. EGLIS consolidated its position as the primary growth engine for the company. Meanwhile, we are actively building market share for Klein City and Winsora as their launches gain traction across key European regions. EGLIS delivered 75.5 million euro sales in the first nine months as European markets scale up after launching in all key countries. This performance is in line with expectations and reinforces our confidence in the product's robust growth potential. Both Esquilera and Santanclopoli maintained self-growth in line with prior years, with a slight growth compared to the last year. In the U.S., performance declined year on year. While Glycerides' large field launch continued to generate growth, these gains were offset by persistent pressure on the legacy portfolio. Products such as cordlantate, texorac, and axon remain impacted by ongoing genetic competition. Additionally, Teixala cells fell versus last year primarily due to a contraction in the overall oral antibiotic market for acne. In the rest of the world, dermatology cells dip year on year, reflecting lower licensed income compared to 2021. Now, let's review financial statements on nexus cells. In terms of P&L, and one's revenue has been covered, gross margin moderated to 64.9% in the first nine months of 2025, as we continue to face ongoing margin pressure primarily driven by higher royalty tiers linked to Illumetri's growth. At 12.5% of net sales, R&D spending remained broadly in line with the same period last year, with the third quarter reflecting a moderation in investment levels compared to the elevated activities in prior quarters. SG&A expenses increased 6% versus the same period last year, as we continue to support egg-based launches in new markets and other key products. As highlighted earlier, we expect SG&A to pick up in the final quarter of the year due to the typical seasonal timing of our marketing activities. Financial expenses improved year-on-year, primarily reflecting an 8 million euros positive impact from the valuation of the equity swap driven by share value increased year-to-date. Finally, a reminder that our effective tax rate remains impacted by the inability to offset the US tax losses against European profits consistent with the full year guidance provided earlier this year. Please move to the next slide to take a look at the balance sheet. Our balance sheet remained very stable in the first nine months of 2025 compared to the same period prior year as shown in the slide. Goodwill and intangible asset decline was driven by depreciation, which outweighed the impact of a blizzard on decapitalization and progress in our pipeline. In the third quarter, capital expenditures remained minimal, primarily related to the recent extended collaboration agreement with CINCI. Our net debt ratio remains low at 0.1, providing continued flexibility to pursue inorganic growth opportunities. The decrease in net debt primarily reflects Soviet cash flow generation during the third quarter. Let's take a look at the cash flow statement next. Company improves cash generation during the first nine months of 2025 by 44 million euros versus same period prior year. Cash flow from operating activities was 146 million euros during the failure, representing an improvement by 40 million euros versus last year, mainly driven by material improvement of profit before taxes, slightly offset by working capital increase as our business grows. Cash flow from investing activities reached minus 104 million euros Improving 20 million euros versus prior year driven by lower investments, mainly 43 million euros in the Medreserve milestone moved in 2024, partially compensated by milestones related to Windsor and Pfizer improvements. Finally, cash flow from financing activities was minus 43 million euros, an increase in cash outflows by 17 million euros compared to last year, driven by higher cash dividends selected by shareholders, and partially offset by the positive equity swap impact mentioned earlier. With this, I would like to pass the word to Carlos for his closing remarks. Thanks a lot, everyone, for your attention.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Thank you, John. As John confirmed, we remain on track to deliver our 2025 guidance and mid-term outlook. As we have a clear ambition to achieve our double-digit net sales caper, through 2030 and the generative margin of approximately 25% by 2028. We are poised to lead in a rapidly expanding medical dermatology market, leveraging a proven platform for sustainable growth. Over the past decade, we have built a foundation that combines scientific depth, operational excellence, and a pipeline with disruptive potential, including several first and best in-class assets. Together with our long-standing relationship with dermatologists and patient communities across Europe, which drive our relevance as a leader in medical dermatology, this strength represents a clear competitive advantage, positioning us to capture meaningful opportunities for both growth and margin expansion. To translate this strength into sustained value creation, we apply a focused and prudent capital allocation strategy. We are investing in current and upcoming launches to drive mid-term growth, actively strengthening our pipeline through internal R&D and licensing, maintaining stable dividend policy, and remaining open to targeted business development and licensing opportunities, all supported by a solid liquidity position. Our strategy of turning disciplined execution into solid financial results is encouraging. As we close the third quarter for 2025, momentum remains strong. Lumenia necklace continue to drive double-digit total sales growth, reinforcing the strength of our dermatology franchise. Looking ahead, we expect further pipeline milestones in the coming months, adding depth to an already differentiated portfolio. We are committed to shaping leadership in medical dermatology in Europe, turning innovation into growth, and delivering lasting value for patients and shareholders. With this, we conclude the presentation. And I hand it back to Pablo for the Q&A session.

speaker
Pablo Divasson
Head of Investor Relations

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

speaker
Nadia
Conference Operator

Thank you so much, dear participants. As a reminder, if you wish to ask a question, please press star 1 1 on your telephone keypad. and wait for a name to be announced. To withdraw a question, please press star, one, and one again. Please then bow or compile your Q&A or studies. We'll take a few moments. And now we're going to take our first question. And it comes to the line of Lucy Cordington from Jefferies. Your line is open. Please ask your question.

speaker
Lucy Cordington
Analyst, Jefferies

Hi. Thank you for taking my questions. Just a few, please. Starting with Ed Bliss. Could you remind us, is the pediatric opportunity included in your current peak sales guide? And what's the overlap there with your current sales force? Or would that require additional SG&A investment? And then with the peak sales guide, have you ever disclosed kind of what that implied penetration would be of the European A to D markets? when you reach that peak. And then secondly, on your midterm guide, how important is a glycerin inflection in terms of reaching that midterm or is it primarily driven by your two biologic therapies? And then finally, I may be looking incorrectly, but I couldn't find the IL-1 rat trial. When might we expect the data from that to read out? Thank you.

speaker
Pablo Divasson
Head of Investor Relations

Thank you very much, Lucy. I'm not sure I got your last question about the MDR1 graph. Is the question about what?

speaker
Lucy Cordington
Analyst, Jefferies

It is when will we expect the data from that.

speaker
Carl Sigalán
Chief Scientific Officer

Maybe we can start with this last question. Yes, thanks a lot, Lucy, for the question. As I mentioned, for our anti-albumin rep, we have just started a phase And we start getting data towards the end of 2026, 2027.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Thank you, Carl. And about your other questions, Lucy. So the application, yes, it's ongoing. It's an important part of our clinical study to generate further data. And yes, the potential of This population is already included in the peak sales estimate, and we don't expect further investment. We don't need further investment. We already have the necessary infrastructure to capture the pediatric opportunity. In terms of the peak sales, we have not disclosed the penetration, but we believe we have the best product in our hands. So we believe that at peak sales, we will be playing a very significant role in treating Lastly, your question about the mid-term, the key is to realize the value on two of our biologics, FDs and Illumetri, and that's what will drive our ambition to grow, double-digit growth and the margin expansion. Glyceria and Wintora will play a lesser role in that regard.

speaker
Nadia
Conference Operator

Got it. Thank you very much. Thank you. Now we're going to take our next question. And the question comes to the line of Guillaume Sampaio from CaixaBank. Your line is open. Please ask your question.

speaker
Guillaume Sampaio
Analyst, CaixaBank

Hello. Thank you for taking my question. So two, if I may. The first one on Agile, of course, the data was quite enticing. I appreciate the additional color that you provide on what you're doing. But you could provide a bit of timeline for the options that you're following to obtain a label update? And the second question is a bit towards 2026. If you could provide us some initial indications on how you're seeing the year in terms of top line and EBIT expansion. Thank you.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Thank you, Guilherme. The timeline is, I mean, for which product? It's a joint. It's a joint. Okay. Can you take this question, please?

speaker
Carl Sigalán
Chief Scientific Officer

You mean, sorry, the joint study?

speaker
Guillaume Sampaio
Analyst, CaixaBank

No, no, no. I mean, so the efforts that you are undertaking to leverage on data that could be similar to a joint to obtain potential more favorable... Yes.

speaker
Carl Sigalán
Chief Scientific Officer

You know, ADE is a chronic disease that requires chronic treatment. That's why generating data that shows the long-term efficacy and safety are very important. We are running a study that is called , where we will generate data on and safety of labricizumab for up to five years. We have recently published four years' interim data that have shown that patients who have been well-controlled after week 16 maintain a very good skin clearance and efficacy for up to four years. And we will have then five years' data next year, 2026.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

And Jerem, about your question about the 2026 outlook, you have to be a little more patient as we typically share these expectations in February, but I think that John has provided already a highlight, right?

speaker
John Garay
Chief Financial Officer

Yes, as Carlos has mentioned, we are making sure to provide detailed performance figures for 2026. I know that my predecessor, Mike, used to share some high-level indications with you all ahead of the fiscal year results. So if some context can help, we can offer that we expect 2026 growth and EBITDA to be in line with the most recent midterm guidance. We expect NETSERV to remain in the double-digit territory. Please bear in mind that our midterm guidance does not include a typical M&A, except We will see certain pressure in the gross margin as we have several unlicensed products that are subject to royalties, which means that actual margin expansion will happen at the beta level as sales are expected to grow more rapidly than S&A expenses once the commercial infrastructure for EBLIS has already been fully deployed in Europe. R&D expenditure of the net sales ratio aligned with the one shown in 2025 seems to be a fair in the near to meet them. So hopefully this helps, and we will disclose further details every next year.

speaker
Nadia
Conference Operator

Thank you. Now we're going to take our next question. And the question comes, Lan, of Natalia Webster from RBC. Your line is open. Please ask your question.

speaker
Natalia Webster
Analyst, RBC

Hi there. Thanks for taking my questions. Firstly, just a follow-up on Epglyph. This continues to grow well quarter on quarter, but I was just curious to hear a bit more about how you're seeing the competitive dynamic evolving in Q3, and if the continued Nemluvio launch has impacted EBLIS's market share in key European markets. And then my second question is on Effektenikonazole. Following the approval in Germany in August, are you able to provide some more details on your launch preparations and thoughts around growth potential for this product over the medium term. Thank you.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Okay, Natalia, thank you for your question. So, as I mentioned before, this dynamic remains very favorable and in line with our expectations. We continue to receive very positive feedback from dermatologists, both in the more experienced ones, in countries where we have gone so very a number of months ago, but also in the newly launched countries, such as in France, the feedback from the doctors remains very consistent. So, very good news, the majority of the prescriptions continue to come from naive patients, and that's very aligned with our strategy, so also confirmation of our expectations and good news there. In terms of Nenluvio impact, it's too early to say as Nenluvio has only launched in Germany, in Europe so far, As we mentioned in our course, we believe that new entrants will expand the market and will remain confident, and that's based on the feedback of the pathology community that the anti-IL-1, anti-IL-13 remains the key class to treat these patients. And also, we believe that IL-31 is more indicated for . But in any case, we believe that new launches will help to make even more noise and expand the market as only 10% of eligible patients that could be treated with advanced biologics or advanced treatments are only treated today with this treatment. So there's a tremendous opportunity to continue to help patients in this class that we need to market expansion. On Eficon at all, we are getting ready for launches in selective countries, and we will more probably in 2026. But we will play a modest role in the contribution to sales . Great.

speaker
Natalia Webster
Analyst, RBC

Thank you.

speaker
Nadia
Conference Operator

Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star, one, one, on your telephone keypad and wait for a name to be announced. Dear participants, please kindly stay connected while your questions are answered. Thank you so much. And now we're gonna take our next question. And the question comes from the land of Jaquin Garcia Quiroz from GB Capital. Your line is open, please ask your question.

speaker
Jaquin Garcia Quiroz
Analyst, GB Capital

Thank you for taking my questions. So the first one, there was a 20 million, a bit more than 20 positive impact in free cash flow from other adjustments, just if you could have more color on what exactly was the cause of that. Then on M&A, would you consider now that I know Epli is still on ramp up, but there's been a few years now since launch, on a more relevant M&A acquisition or you're still targeting smaller deals? And then lastly, could you have a bit of insight on to high-trend NET superativa and the alopecia areata market? Do you have some information on how big could this be for you? Thank you very much.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Thank you, Joaquin, for the question. So I will leave the first one to John, but then he answers the second and third questions on my side. In terms of M&A, we remain extremely focused on delivering value for the company in organic growth to make sure we maximize the penetration of and of course to moving our assets into POC. So that's where we dedicate a lot of our efforts. However, licensing and M&A continues to be an important part of our strategy. So far, we are looking at both opportunities from an acquisition perspective and then from licensing from early and later stage opportunities in all geographies. HS and AAS and alopecia areata. These are two areas where there's tremendous from a patient perspective. and that's based on strong feedback from the dermatology community. We're very excited to have two assets that have potential to be the first, the best in class. And we believe that if we get positive results and our target profile is confirmed, that we will have a therapist in our hands that will have a significant impact on the company, on the patient, but also from a sales perspective in the company. Now we're not prepared to provide more specifics here, but it could be major impact to the company if the target profile is confirmed in the clinical trials.

speaker
John Garay
Chief Financial Officer

John, yeah, sorry for the first question, Joaquín. Good morning, Joaquín. Thanks for your question, yes. The improvement you have seen in our cash flow statement relates to an advanced payment received during the quarter regarding a license deal for one minor product in our portfolio. To commercialize this in the countries included in the Eastern Europe and Western Asia, mostly the Commonwealth of Independent States, there is no impact in the P&L as it will be recognized in the future. Yes. Hope it helps.

speaker
Joaquín

Thank you.

speaker
Nadia
Conference Operator

Thank you. Now we're going to take our next question. And the question comes from JMSQ Biomice from Banco Santander. Your line is open. Please ask your question.

speaker
JMSQ Biomice
Analyst, Banco Santander

Hi, good morning. So a few questions from my side. Could you remind us the pediatric indication for FGLIS? When do you think it can be launched or if When could we have some impact in sales, basically? Second, on Seisada in China, what could we expect here? Any news on what's the potential in revenues? And then a little bit of housekeeping for the modeling. Can you remind us tax rate for this year, more or less, where could we stand? Also, the milestones for 2026. if you can remind us. And final question. Yeah, my final question is a spicy one. I don't know if you will answer, but basically, when you see Bloomberg consensus at around 280 million EBITDA for 2026, how do you feel about this figure? Is it something fair? Is it something ambitious or you feel comfortable with that? Thank you very much.

speaker
Carl Sigalán
Chief Scientific Officer

Yes, Jaime, this is Carl speaking. Thanks for your question. The pediatric study called Adorable One and Adorable Two are run by our partner Eli Lilly. For the first one that covers participants six months to younger than 18 years, The LILI expects primary completion in December this year and full completion in December 2026. And the DORECL2 is then the long-term safety and efficacy, and the primary completion is expected in December 2027. Then after that, of course, there is the compilation of the data, the submission. And then the extension of the lay will be before we then can finally launch.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

You want to comment on CESARA China as well?

speaker
Carl Sigalán
Chief Scientific Officer

Yes. On CESARA China, as I have mentioned in the presentation, we expect the approval of CESARA in China still within this year.

speaker
Carlos Gallego
Chairman and Chief Executive Officer

Thank you, Carlos. John, you want to take the other questions?

speaker
John Garay
Chief Financial Officer

Yes. Thank you very much, Carlos. I think the first question related to the tax rate for this year, so right now the tax rate is around 40%, which is a significant improvement versus prior year one, and it's aligned with the full year guidance we provided for this year. We are working as hard as we can to try to be more effective here, but right now I'm not confident providing any guidance for next year. The other two questions regarding to 2026 in the sense of milestones and EBITDA. If we start with milestones, I think that, again, we are in mind to provide the test performance figures for 2026. But we are in mind, I think, to assume certain milestone levels similar to 2021. Initially, it could be a good estimate, and we will provide further details in February when this looks in the guidance. Regarding the Bloomberg consensus, right now we are very positive about the performance of the company and confident in achieving our stated guidance. That's why we have reiterated it this quarter. Coming back to next year, it is still too early, but so far I cannot tell you if we agree or we do not agree. It is an statement based by third parties and what we have shared just in this call is that we expect to remain in the mid-term range provided for the company. We will provide more information in February, so please stay tuned. Thank you very much. Thank you.

speaker
Nadia
Conference Operator

Thank you. Dear speakers, there are no further questions for today. I would now like to hand the conference over to our speaker, Paulo de Vasson, for any closing remarks.

speaker
Pablo Divasson
Head of Investor Relations

Thank you very much, Nadia. Thank you. As there are no further questions, ladies and gentlemen, this concludes our today's conference call. Thank you for your participation. You may now disconnect.

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