Ladies and gentlemen, thank you for standing by, welcome to the Q1 2023 financial results and business update of Almirall. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. If you wish to ask question, please press star one one on your telephone. I would now like to turn the conference over to Pablo Divasson. Please go ahead.
Thank you very much, Roberto. Good morning to everyone on the call. Thank you for joining us to review Almirall's Q1 2023 results and business update. As per usual, you can find the slides to this call on the investors page of our website at almirall.com. Please move to slide two. I would like to 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. With that, please advance to slide three. Presenting today we have Carlos Gallardo, Chairman and Chief Executive Officer, Mike McClellan, Chief Financial Officer, and Karl Ziegelbauer, Chief Scientific Officer. Carlos will start with the highlights, biologic growth drivers, and key products. Karl will provide you with details on the progress of the pipeline before passing to Mike to review the financials.
Carlos will make the closing comments before opening up for a Q&A session. I will like now to pass it over to Carlos Gallardo, our Chairman CEO, to discuss the quarterly highlights. Please move to slide number five.
Thank you, Pablo. Good morning, everyone. I am pleased to say that Almirall is off to a good start from both financial and pipeline perspectives. The strong business momentum from our growth drivers continues, while we continue to prepare for lebrikizumab launch. Based on the good business performance in quarter one, we are reiterating our full year 2023 guidance. The performance of the business was driven primarily by our European dermatology business, underpinned by our recently launched products, that I will discuss more later in the presentation. Let me highlight the performance of some of those. We continue to see strong performance from Ilumetri across geographies, with continued good uptake in Germany and solid contribution from recent country launches.
Since the launch of Wynzora and Klisyri in Europe, we continued increasing market share in key countries, particularly in Spain and Germany for both products, while making excellent progress with the rollouts in other European geographies. We also continued to work on the pipeline with positive clinical updates on lebrikizumab. Our ADvantage phase IIIb market access study headline results are available and showed positive results. Karl will shed more light on this later in the presentation. We continue to work with our partner, Eli Lilly, towards a targeted late 2023 European approval. Launch soon thereafter. Klisyri last field study has shown that the administration of Klisyri in a surface of up to 100 sq cm has been well tolerated.
Finally, in the early stage pipeline, the phase I study of our anti-IL-1RAP is ongoing, and we expect to launch phase I for IL-2 mutein during the year. Let's move to slide seven for a deeper dive on Lebrik. In terms of key events, let me quickly revisit the timeline of the milestones, leading us to the expected approval later this year. During this first quarter of the year, the ADvocate and ADhere studies were finally published in scientific journals. Another important milestone ahead of the launch has been completed recently, as we obtained positive headline results for the ADvantage phase IIIb study. We are positive on the good clinical development of lebrikizumab, and confident on the expected approval of the product towards the end of the year, as we intensify the efforts to be prepared for a successful commercial launch.
Let's move to the next slide to discuss the ADvantage in more detail. The ADvantage study headline data is already available, achieving positive results. Safety was consistent with the known profile of lebrikizumab. As a reminder, the ADvantage study is a randomized, double-blind, placebo-controlled phase III clinical trial to assess the efficacy and safety of lebrikizumab in combination with topical corticosteroids in adult and adolescent patients with moderate to severe atopic dermatitis who are not adequately controlled with cyclosporine A, or for whom cyclosporine A is medically not advisable. Let's move to the next slide to discuss Ilumetri a little bit in further detail. On the left side, you can see the market dynamics of the anti-IL-23 class in Germany, where the class continues to lead in new patients market share.
There is a small decline in February, possibly impacted in part by some biosimilars entering the market. The IL-23 trend remains robust, with around 40% market share of new patients within biologics. As you can see on the right side chart, Ilumetri continued to demonstrate strong performance during the quarter, with net sales of EUR 38 million in this first quarter 2023. Contribution of other European countries compared to Germany continues to grow and now stands at around 50%, a trend we expect to continue. Overall, we are pleased with Ilumetri's continued growth, and we expect the good level of performance to carry on for the rest of the year. Let's move to the next slide to complete the update on other key products. Let's start with Seysara.
We have seen continued volume growth throughout quarter one, which helped drive sales growth of 12% versus the same quarter last year. We have achieved a 5.8 market share in the antibiotic market and continue to focus our efforts on driving demand and improving the gross to net through better payer coverage and increasing access to more commercial lives. In the U.S., Klisyri has received a strong recommendation in the AAD guidelines. By comparison to the same quarter last year, sales grew by around 57%. This is a very good result for a new product, particularly when launched in a market with numerous generic alternatives. Around 5,700 healthcare professionals have prescribed now Klisyri since its launch, and we continue to receive very good feedback with good patient engagement.
We continue to differentiate Klisyri from what is already available in the market based on efficacy, tolerability, and convenience. Additionally, we are working on the large field label expansion over the midterm. Preliminary data reveals that the product is well-tolerated. We hope to launch a large field label next year in 2024 in the U.S. and in 2026 in Europe. With both products, Klisyri and Seysara, there has been good improvement in quarter one in TRx volume growth and market share. We think these are very good products with growth potential that will help our platform in the U.S. Moving on to Wynzora for patients with moderate to severe psoriasis, which we launched in May 2022. We are pleased with the progress, having achieved sales of over EUR 3.5 million this quarter, with growing market shares in Spain and Germany.
I will pass to Karl to cover in detail our pipeline section.
Thank you, Carlos. This slide shows you the progress of our pipeline. We continue to advance our promising late-stage pipeline while building an exciting early pipeline. For lebrikizumab, we have filed a marketing authorization application for atopic dermatitis with the EMA, and we expect approval in Q4 2023. The ADvantage phase IIIb study met the primary endpoint at the week 16 analysis. For Klisyri, we have completed the clinical study addressing the extension to large field in the U.S. This phase III multi-center open label single arm study evaluated the safety and tolerability of tirbanibulin ointment 1% applied to a field of approximately 100 square centimeters on the face or balding scalp in about 100 adult patients with actinic keratosis. The administration of Klisyri was well tolerated.
Based on those data, we plan a submission to FDA in Q3 2023 and would expect a potential approval of the label extension in 2024. As mentioned previously, a potential launch in the EU is targeted for 2026. For Seysara in China, the phase III clinical study met the primary and key secondary endpoint. We plan to file with the National Medical Products Administration in Q3 2023. For efinaconazole, we are under regulatory review and target an approval at the end of 2023. The phase I for our anti-IL-1RAP monoclonal antibody is ongoing. We aim to start phase I for our IL-2 mutein Fc fusion protein that we develop in collaboration with Simcere later this year.
As you can see, we are making very good progress with both our early and late-stage pipeline, and we are on track to strengthen our leadership position in medical dermatology. Now let's move to slide 14. Let me now explain the next steps for lebrikizumab in more detail. As mentioned, we submitted a marketing authorisation application to EMA in October 2022. This application is currently under review, and we expect approval in Q4 2023. In terms of clinical update, the ADvantage phase IIIb study met the primary endpoint at week 16 after the induction phase. The study will continue up to week 52. We plan to report the detailed data at one of the relevant scientific meetings later this year.
As already mentioned, the ADvantage trial is a randomized, double-blind, placebo-controlled, phase III clinical trial to assess the efficacy and safety of lebrikizumab in combination with topical corticosteroids in adult and adolescent patients with moderate to severe atopic dermatitis that are not adequately controlled with cyclosporine A or for whom cyclosporine A is medically not advised. In addition, a pediatric study was initiated by our partner, Eli Lilly, in October 2022. We're also in advanced planning stage of an extension study to explore long-term benefits of lebrikizumab for up to five years and expect recruitment to be initiated in Q2 2023. We believe that atopic dermatitis is a chronic disease that requires long-term treatment. We think that lebrikizumab, with the potential as shown in our ADvocate studies to control the disease effectively with every four weeks dosing in the maintenance phase, is suitable to achieve this.
Furthermore, we are working with our partner in Eli Lilly on additional clinical studies to maximize the value of lebrikizumab. In summary, we continue to be very excited about the progress we're making with lebrikizumab and the totality of the data and the profile that is emerging. Lebrikizumab shows a consistent profile across the clinical development program with more than 2,000 patients. The safety profile is mild and consistent with prior lebrikizumab studies in atopic dermatitis. Atopic dermatitis is an IL-13 dominant disease, and we believe lebrikizumab is the best antibody targeting IL-13. Finally, for the maintenance of patients that responded at week 16, every four weeks dosing shows strong response that are like every two weeks dosing. Those data demonstrate the potential benefit that lebrikizumab could bring to both HCP and patients. With that, I hand over to Mike.
Thanks, Karl. On to slide 16. We're off to a good start for the year. As Carlos mentioned, Q1 2023 showed solid performance with net sales growth of 6%, giving us the confidence to reiterate our 2023 guidance. We've seen strong sales growth in Europe from the dermatology portfolio, which helped drive the overall net sales and core EBITDA increase. We achieved total EBITDA of EUR 51.8 million in Q1 2023, down from Q1 2022, mainly due to the lower contribution of other income due to last year's AstraZeneca Covis milestones. Most of the revenue related to the Covis agreement was recognized in 2022, we should expect a lower contribution in 2023 and going forward.
In Q1 2023, our gross margin came in at 65.4%, which we have highlighted in previous quarters was impacted by higher energy costs and inflation, which affected some of our material purchases. This is in line with what we anticipated. SG&A for Q1 2023 was EUR 106.7 million, as we continue to invest heavily in our newly launched products, as well as some pre-marketing ramp-up for lebrikizumab, which will accelerate during the year. R&D investments increased to 10.3% of net sales in Q1 2023, compared to 9.6% that we had in Q1 2022, as the first quarter is typically a lower R&D investment quarter. We expect the levels to normalize for the full year in the range of 12% of our sales.
We finished Q1 2023 at 1.1x net debt to EBITDA, an increase compared to Q4 2022, mainly explained by the high amount of investments we had in the first quarter, including the Efficib/Tesavel extension deal, the Physiorelax acquisition, Ilumetri and Klisyri milestones, and an upfront payment to Isolex. We move to slide 17. As you can see, the dynamics of net sales here. The European dermatology business had a very strong performance with an 11.4% increase year-over-year. We also had a strong Q1 performance from our general medicine and OTC businesses in EU, driven by good seasonality, which more than offset the expected decline in Efficib/Tesavel following the patent expiration and price decrease experienced in Q4 2022. Our U.S. business recorded a slight decrease in Q1 2023, and I will provide further details on the next slide.
Rest of the world dermatology sales showed good year-on-year performance, while general medicine has seen a small decline year-on-year, driven by Immunorex in LATAM, which had a high demand during the pandemic and winter months in 2022. Overall, it's important to reiterate that our portfolio has limited patent expiry risk going forward in the midterm, especially now that Efficib/ Tesavel patent has expired and we are managing the pricing impact. Let's take a closer look at the dermatology business on the next slide. On slide 18, as you can see, we had a strong performance in Europe, driven by the growth of Ilumetri. Other EU products are also benefiting from the initial launches of Klisyri and Wynzora in key markets as highlighted by Carlos.
Focusing on our U.S. business, we see growth in the TRx and market share of both Klisyri and Seysara, which are being translated into higher revenue, although we still need to improve the conversion to net revenue as we work to create a strong customer base for the brands. As you can see, the legacy business in the U.S. remains under pressure from the ongoing generic erosion related to Aczone and Tazorac. In the rest of world, there's some growth, including the introduction of Finjuve in South Korea with a partner. Moving on to the full financial statements now on slide 19. We've seen the net revenue development in the previous slide, let's focus on the rest of the P&L. Gross margin was in line with expectations at 65.4%, given the ongoing pressure of energy costs and material inflation previously highlighted.
Other income was lower than Q1 2022 due to the milestone income recognized last year, as mentioned previously, that did not repeat.
R&D expenses are up double digits from 2022 and reached 10.3% of net sales, a figure we expect to accelerate during the year to a full year level around 12% of sales. SG&A investments grew in the low double digits compared to Q1 2022, this will also accelerate during the year as we prepare for the expected launch of lebrikizumab. Financial expenses have been impacted by a lower share price connected to the equity swap on the balance sheet, the underlying financial expenses year-over-year are quite similar. I'd like to remind you that our effective tax rate is affected by the inability to deduct U.S. tax losses against the profitable European business. We expect this to continue going forward.
We do not have any unusual items in the quarter, therefore, the normalized net income is the same as the net income. Please move to the next slide to look at the balance sheet in more detail. On slide 20, I'll just highlight a few key important factors. First, some financial assets have been reclassified to accounts receivable following the agreement with Covis to advance certain milestone payments related to the China respiratory business. Second, we finished Q1 2023 with a leverage of 1.1x net debt to EBITDA. As I said before, this is due to a high amount of investment we had in the first quarter, we are comfortable with our debt ratio. Let's look at the cash flow statement on the next slide.
On slide 21, you can see, we delivered operating cash flows of EUR 1.2 million in Q1 2023, a level similar to last year, as operating cash flow is typically low in the first quarter due to the timing effects of accounts receivable and accounts payable. In the investing activities, we made key activities in Q1 2023, such as the Efficib/Tesavel extension deal, the Physiorelax acquisition, Ilumetri and Klisyri milestones, and an upfront payment to Isolex. The divestments line here refers to the milestones and royalty collections from AstraZeneca and Covis. These have been classified as investing activities due to the reduced focus in our operations and are lower than 2022 based on the schedule agreed. We do expect the overall cash flow to improve in the next three quarters, very similar to the pattern we saw in the previous year.
Let me now pass it back to Carlos for his closing remarks.
Thank you, Mike. Overall, you know, as you've seen, we are very pleased to have delivered a very good operational performance in this first quarter. We also continue with all the preparations for a potential lebrikizumab launch, first approval later this year and launch thereafter. We are very pleased on how things are going in terms of our launches in all countries in Europe. Let's say that operationally we are ramping up well. We are confident that we can deliver and that we are delivering in Europe, and that we will do a good job with lebrikizumab. The progress in the pipeline also is very positive. We are hitting all our expected milestones, so good news there. To close here, of course, we continue to explore potentially inorganic growth. We have a healthy balance sheet.
We are looking for small opportunities built on that might, you know, reinforce the business from an inorganic way, but at the same time, do not distract us from our goal of delivering in Europe with the biologics. Overall, you know, very pleased with how things are going. Thank you very much. We conclude this presentation. Pablo, I hand back to you for instructions on the Q&A.
Thank you very much, Carlos. Roberto, back to you to start the Q&A, please.
Ladies and gentlemen, we now begin the question and answer session. As a reminder, if you wish to ask a question, please press star one one on your telephone. If you wish to withdraw your question, please press star one one again. We are now taking the first question. Please stand by. The first question from Jo Walton from Credit Suisse. Please go ahead. Your line is open.
Good morning. Thank you. A few questions, please. Firstly, on Ilumetri, you pointed to a biosimilar launch impacting in February. I wonder if you could tell us a little bit more about that, whether that's a, you know, something that is permanently going to reduce your price in some way. On Klisyri, can we just confirm that if you are going to be able to file in the third quarter, it should be a six-month review? We should see in the probably mid-2024 your ability to launch Klisyri large field in the U.S. Just to confirm that you've effectively, with the positive tolerability, there's nothing else you need to do in the U.S. We understand there's more that you need to do in Europe.
On Seysara, you're going to be able to file in 3Q. Have you made any more decision on how you will commercialize that? You're going to file before you have a partner, or could we see a partner being brought in quite quickly? On lebrikizumab, you talk about recruiting a long-term extension study. Will that have an active comparator in that? Is there anything you can tell us? You say that you are discussing with Lilly of more studies that you might do. Can you give us some idea of what those might be? My final Lebrik question is just to confirm that you haven't had any significant
Clock stoppage within the EMA, and that we should be able to see a full approval in the fourth quarter. Could you give us perhaps your best guess of which month we'll see the CHMP decision on it? Many thanks.
Sure. Thank you very much for the question, Jo. I think that most of the questions are for either Mike, or Karl. I think the first one was.
Yeah, I can take the first one on Ilumetri. What we were referring to is on the slide number nine, you can see in the month of February, there's a slight tick up for the anti-IL-17 class in Germany. That was because of a biosimilar launch of one of the IL-17 class products. It really hasn't affected the momentum of Ilumetri. It's just something that we wanted to point out on that slide. For Physiorelax, I'll pass that over to Karl.
Thanks for your question, Jo. I mean, on Klisyri, we have the situation that in the U.S., we had an agreement with an FDA for the extension to large field to have a clinical program containing a PK study that we already completed earlier, and an open label safety and tolerability study where we just reported a positive outcome. Based on that, we plan a submission for Q3 this year and then expect an approval in 2024, maybe around mid-year or so, but we'll have to see what the exact timelines will look like.
In terms of Seysara China, you know, we're actively looking at potential partnerships. It's a little too early to say if we will announce and sign something before the filing or not. We are definitely in active discussions to find the right partner in China.
For lebrikizumab, I think, your first question was around this long-term extension. I mean, this long-term extension is a basically study where we will try to the extent possible to move patients from our phase III studies into extension study because they have been already treated with lebrikizumab for up to a year. With that design, there is maybe not so much to think about an active comparator for this type of study. For additional studies, you know, we're looking very broadly based on the excellent properties of lebrikizumab and the data we have seen so far. You know, what other studies that would potentially make sense?
We have already, you know, covered a broad spectrum of different patient populations now, for example, with the ones we reported today, the ones that are not adequately controlled by cyclosporine A. As you may know, Eli Lilly is doing a dedicated study in patients of skin of color and patients that have been pre-exposed to Dupixent. Both, I think, important studies and important patient population. A pediatric study is also ongoing. In addition to that, you know, we are exploring various other options, but today it's a bit premature to comment on the detail. Your final question on lebrikizumab in terms of the regulatory process.
I think what we can say today that the regulatory process is on track and we expect an approval in Q4 this year. In terms of an exact month, that I think is a bit premature to comment on.
Thank you.
Thank you. We are now taking the next question. Please stand by. The next question from Alistair Campbell from RBC. Please go ahead.
Thanks for answering the questions. Just two, please. First of all, a question for Mike, just on the tax rate. Obviously, your guidance elements are all pre-tax. I'm just wondering if you can give me some kind of sense of how you think the net tax rate would look for the full year. Obviously, it looked very high in Q1. A quick question for Karl on just the general eczema market, just some thoughts on the competitive landscape. I think since the last time we spoke, we've seen, for instance, data from Roivant on the tapinarof cream. Just your sense of how some of those other competitive dynamics are reading out and what you think about that relative to lebrikizumab, please. Thank you.
I'll take the first question on tax rate. You know, when we gave the guidance, we did indicate that the tax rate was going to be elevated because of this situation in the U.S. I would expect the tax rate to remain elevated around the level that we saw in the first quarter. Too early to tell. It really depends on exactly how the income falls between the different buckets, the U.S. and EU. I think the first quarter is already a good indication of a relative rate.
I think on the competitive landscape, on AD, perhaps a couple of thoughts. First of all, you know, on the JAK inhibitors, we are now seeing that the European evaluation of the safety is being completed, basically indicating that, you know, there are, you know, concerns about the broad utility of check, and actually the bracket recommended If alternatives are available in certain patient populations, to use those. The interesting piece is it's for all checks in all indications. This is for patients that are, you know, older than 65 or have certain risk factors, for example, in cardiovascular or also, you know, at risk of thrombosis, things like that. That certainly will in a way limit JAK inhibitors.
We have to see to what extent. Now, in terms of other biologics, we see the anti-IL-31, but those are mainly targeting the itch but not the eczema. We believe to effectively treat AD, both aspects need to be covered like we're seeing with lebrikizumab. Maybe a comment on the anti-OX40. You know, here we have, you know, two advanced compound, one targeting OX40 from Sanofi. This is perhaps a little weaker in terms of early data as compared to dupilumab, and the other is from an Amgen targeting the OX40. They are now advancing into phase III, including it in every eight week schedule. At the end, we have to see how the data will look like.
There have been some concerns, maybe more involving to the immune system, but in essence, I think, it's too early today to comment. Overall, we still think that we are very well-positioned with lebrikizumab and with the profile that we're seeing, and we believe we will be very competitive in that space.
Thank you, Karl. Very helpful. Thank you.
Thank you for your question. We are now taking the next question. Please stand by. The next question from Francisco Ruiz from BNP Paribas. Please go ahead. Your line is open.
Hello, good morning. I have three questions, if I may. One is a follow-up on the tax rate. If, taking into account the tax rate on the P&L, we will see a similar cash tax in the cash flow statement on this. The second one is if you could give us more detail on the milestones this quarter, and if you could anticipate what is the milestone that we could expect on lebrikizumab approval at the end of the year. Last question is on ESG. Sorry, SG&A. We have seen that the cost has been performing better than sales, but you commented that you expect an acceleration during the year due to the launches of the new products.
Could you quantify where could we see the SG&A at the end of the year? Thank you.
Yeah. On the tax rate, I mean, the cash tax will probably be very similar to last year. It really depends on, you know, whether or not we get a Q4 refund from the Spanish authority or not. Sometimes it's Q4, sometimes they push that payment into January. That will have a little bit of effect on the cash tax, but we're expecting it to be very similar to last year. In terms of the milestones, I mentioned the key buckets. We had an extension payment for the Efficib/Tesavel. We purchased the Physiorelax asset, and then we had some milestone payments related to Klisyri as well as a payment on Ilumetri for participating in the psoriatic arthritis trial that Sun Pharma is doing to try to get an approval there.
For the full year, I would expect this to be, you know, roughly in the EUR 80 million-EUR 100 million range in terms of investments, absent any new bolt-on acquisitions or major licensing we do. If we do anything that's not contemplated right now, that could go a little bit higher, but we'll manage that and we'll try to manage the communication. The lebri milestone is expected to be around EUR 20 million at the end of the year for the approval in the EU. In terms of SG&A, when we gave the guidance, we talked about mid-single digits. We expect that still to be for the full year. If you look in the Q1, it was only about a 2% increase, so that will accelerate.
Partially as we start to get ready for the lebrikizumab, we will be putting more resources, particularly into Europe in the second half of this year. That's where you'll start to see the acceleration.
Thank you very much, Mike.
Thank you for your question. We are now taking the next question. Please stand by. The next question from Guilherme Sampaio from CaixaBank. Please go ahead. Your line is open.
Hello. Thank you very much for taking my question. Three, if I may. The first one, net sales growth was slightly above the guidance for this year, in Q1. If you could provide some color on the puts and takes for the remainder of the year. Second, there was some quarter-on-quarter slowdown in Klisyri. Just, there was not a lot of seasonality in Solaraze. Just whether you could provide some color on what are the main drivers of this slowdown. Third, if you could provide some color on the ADvantage efficacy data. Thanks.
Sorry, the third question?
ADvantage. Sorry.
ADvantage. Okay.
On Advan-
Sorry. Let me take the first two. I guess, Karl, you can take the third one.
Sure.
Yeah. We had a good quarter. We were slightly above. We saw some good seasonality, particularly in Spain. We had about EUR 3 million year-on-year gain in the cough and cold. We also saw a good seasonality from the allergy products. We still feel confident with our, you know, low to mid-single digit sales growth for the year. Let's see how the remaining quarters will play out, but I think we're in good shape so far. Klisyri did go down a little bit quarter on quarter, but Q4 is typically a higher quarter for the treatment of actinic keratosis, particularly in the U.S. You come off the summer sun and a lot of people go in to get treatment in the fall and winter.
That's just a little bit of a, of a seasonality. It's not a huge amount. That we would expect to see that pattern going forward as well. Karl, if you want to take ADvantage.
Yeah. Thanks for the question. The ADvantage trial, as mentioned, is a trial to explore efficacy and safety of lebrikizumab in a, what you can call a hard-to-treat patient population. These are patients that have been treated with cyclosporine A already and still need further treatment or for whom cyclosporine A is medically not advisable. This trial has the size of about 300 patients. It's adult and adolescents. It also includes patients that have been pre-exposed to Dupixent. we'll learn more about this population as well, pre-exposed to Dupixent in addition, having failed on cyclosporine or for which medically this is not advisable. The primary endpoint was after the induction phase at week 16.
It's patients achieving an EASI-75. This primary endpoint was met, and this and detailed data, as mentioned, will be then presented at one of the scientific meetings later this year.
Thank you.
Thank you for your question. We are now taking the next question. The next question from Jo Walton from Credit Suisse. Please go ahead, your line i s open.
Excuse me. Just to follow up, you mentioned in the ADvantage study that some patients had had a pre-exposure to Dupixent. Can you give us an idea of how big that group is? Whether you'll be able to call that out with specific detail and publish that before you get the chance to launch the drug so that you can use that with your marketing?
Well, yes, happy to talk about that. I mean, that is, was a smaller portion, you know, as, if the patients, you know, need to meet both criteria and are more, I think, difficult to get. We are in the process of analyzing all the detailed data that we received. We are reporting today just the top line. As mentioned, we will publish those results in a scientific congress later.
Thank you.
Thank you for your question. There are no further questions at the moment. I will hand back the conference over to Mr. Pablo for closing remarks.
Thank you very much, Roberto. 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.