Almirall, S.A. (ALM) Earnings Call Transcript & Summary

Thank you, Nadia. Good afternoon to everyone on the call. Thank you for joining us on this call to review the 16-week data from lebrikizumab Phase III study. As usual, you can find the slides to this call on the Investors page of our website at almirall.com. Moving to Slide 2. I would like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. With that, please advance to Slide 3. Presenting today, we have Gianfranco Nazzi, Chief Executive Officer; and Karl Ziegelbauer, Chief Scientific Officer. Gianfranco will start with a focus on the atopic dermatitis market. Karl will then provide you with detail on the atopic dermatitis, the IL-13 pathway and the 16-week Phase III of lebrikizumab. Gianfranco will then make the closing comments before opening up for a Q&A session. I would like to pass you over to our CEO, Gianfranco Nazzi.

Thanks a lot, Pablo, for the introduction, and good afternoon to everyone on the call. We are very pleased to update you today on lebrikizumab Phase III 16-week data. And let me start with the holistic view of the atopic dermatitis market within the context of our focus on medical dermatology. The medical dermatology market is over $40 billion and growing at double-digit rates. Our medical dermatology portfolio includes key treatment for each of our core therapeutic areas, and one of our key strengths is our position in an attracting indication within this space. We have continued to positively surprise the market with our first launch of a biologic in Europe [indiscernible] psoriasis. And today, we are providing further details of a very significant opportunity we have with our innovative biologic, lebrikizumab for the atopic dermatitis. Atopic dermatitis is an underserved $5 billion market, growing at 22% CAGR, with a relatively highly unmet need for new and different therapies. This graph shows a substantial market opportunity, and the good news is that today there are only 2 biologics that are marketed, dupilumab of Sanofi and tralokinumab by LEO Pharma. Since the launch of dupi, Sanofi have been able to secure very good market access in Europe. This is positive indicator for lebri as well -- we do not have to create the market access in atopic dermatitis. And instead, we can follow up on what's already been created from dupilumab. Some experts believe that the atopic dermatitis market will grow over time and to be similar to the psoriasis, which I remind you is approximately $20 billion. We are excited by the emerging profile of lebri. And Karl, later in his presentation, will provide you further details about what it has to offer to our patients. In the meanwhile, as an organization, we are working very hard to ensure a successful launch of the product in late 2023. Let's move to the next slide. This slide show you recent development within the European market for atopic dermatitis. Since we exercised the option on lebrikizumab, there has been some positive development in the market even as we have seen positive updates on the profile of lebrikizumab. It's also clear that biologics are becoming the standard of care. Today's announcement, which we view as very positive for Almirall, validate the hypothesis that indeed lebrikizumab is a very interesting molecule. Sanofi, the dupilumab, has obtained market access nearly everywhere in Europe, which helped to open the way for further incumbent to that indication. We see the global peak sales potential for dupi of around $13 billion, as stated [indiscernible] as an important external validation of our lebri potential. While there are a number of products under development, there remains a significant need to provide new options to patients. The atopic dermatitis market is large and growing with biologic penetration rate still low. Similar to what has transpired in the psoriasis market, we expect patient and physician to try a number of medicines. This slide tells you why we are so excited by the opportunity with lebri offering a compelling profile and met the primary and all key secondary endpoints. Lebri has a strong efficacy profile, having achieved significant improvement with more than 50% of the people treated achieving at least 75% improvement in the overall disease severity as measured by the EASI-75. It also offers clinical meaningful improvement in itch and other important patient-reported outcome compared to patients taking placebo. There is a fast onset of action, rapidly improved skin and itch symptom in as early as 4 weeks. These Phase III results confirm lebrikizumab may potentially offer an interesting combination of efficacy and safety. Within this context, let me give you more details. We are very excited about the 16 weeks result presented at the American Academy of Dermatology by our partner, Eli Lilly. Lebrikizumab delivered rapid improvement in skin clearance, itch, quality of life measure for those with moderate-to-severe atopic dermatitis. The data strongly reinforced our belief that lebrikizumab represent the next generation of biologics in atopic dermatitis. We remain very confident in lebrikizumab, and we are looking forward to dossier submission during this year, where we trust the 52-week result from ADvocate 1 and 2 will further reaffirm the profile of this product and provide much needed relief for people who struggle with this chronic lifelong disease. I will now pass over to the call to Karl, who will discuss in more detail the characteristic of the atopic dermatitis and will elaborate on the science of biologics and lebri in particular. Thank you, Karl.

Thank you, Gianfranco, and welcome from my side. So I'm extremely thrilled today to discuss with you the first Phase III result of lebrikizumab, which we shared today following the presentation last week at the AAD in Boston. Let me start by reminding us what atopic dermatitis is about. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin disease. It is characterized by itchy, red, swollen and cracked skin amongst other nondermatological comorbidity. It poses a significant burden on patients' quality of life as well as other health care resources. Atopic dermatitis can occur at any age. It typically starts in the childhood with changing severity over the years. Prevalence in the pediatric population could be as high as 20% with all severities of the disease. Incidence is increasing just as is for other atopic conditions such as asthma or rhinitis. According to the WHO 2010 Global Burden of Disease Survey, atopic dermatitis is associated with the highest number of disability adjusted life year of all skin disorders. Anxiety and depression are frequent comorbidities. Let me now turn on the next slide what we know about the molecular drivers of this disease. Recent data suggest that the cytokine IL-13, rather than IL-4, plays a central role in type 2 inflammation in atopic dermatitis. IL-13 is a central inflammatory mediator in atopic dermatitis and may underlie a range of signs and symptoms, including skin barrier dysfunction, itch, infection and hard thickened areas of the skin. When analyzing protein levels additional skin of atopic dermatitis patients, IL-13, but not IL-4 was overexpressed as shown on the left graph. In addition, as shown on the right graph, IL-13 overexpression correlates with disease severity. Next slide. As already mentioned, IL-13 is a central inflammatory mediator in atopic dermatitis and influences skin barrier dysfunction, itch, infection and skin thickness. On a molecular level, IL-13 binds the 2 receptors, as shown on the figure of the left side. IL-13 binds on the one side to the heterodimeric receptor, IL-4 alpha IL-13 or alpha 1, leading to the activation of downstream signaling pathway and Th2 inflammation. On the other side, IL-13 binds to IL-13 receptor alpha 2, IL-13 receptor alpha 2 is a monomeric receptor and hypothesized to act as a decoy receptor potentially neutralizing the excess of IL-13. Lebrikizumab binds to IL-13 with very high affinity as an epitope that prevents the formation of the IL-13, IL-4 receptor alpha, IL-13 receptor alpha 1, trimeric signaling complex, but not the binding of IL-13 to the IL-13 receptor alpha 2. Furthermore, lebrikizumab has a high bioavailability. On the next slide, I will explain the differences in the mode of action of the different antibodies for atopic dermatitis. I would like to spend some time to go through this slide in detail to emphasize why are we so excited about lebrikizumab from a mechanistic perspective. Here, we see lebrikizumab in the middle compared to 2 monoclonal antibodies on the market in that space, dupilumab and tralokinumab. Dupilumab prevents formation of type 1 and type 2 receptor complexes, blocking both IL-4 and IL-13 downstream signaling, while lebrikizumab and tralokinumab target IL-13 only. Tralokinumab binds to an epitope of IL-13 that prevents both the blocking of the type 2 receptor complex as well as the IL-13 receptor alpha 2, the decoy receptor, thereby interfering with a potentially physiologically relevant IL-13 recycling. Lebrikizumab, on the other hand, specifically prevents formation of the type 2 receptor complex, thus blocking type 2 receptor signaling, but not endogenous IL-13 recycling through the IL-13 receptor alpha 2. Furthermore, lebrikizumab has a higher affinity for IL-13 as compared to tralokinumab. What is important in summary is that not all antibodies for atopic dermatitis are the same. We believe that with its unique profile of targeting with high affinity, the relevant part of the IL-13 signaling, lebrikizumab offers a best-in-class value proposition for atopic dermatitis patients. Let me now introduce ADvocate 1 and 2. This Phase III program was initiated in October 2019 in patients with moderate-to-severe atopic dermatitis, designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients. ADvocate 1 and 2 are ongoing 52-week randomized, double-blind, placebo-controlled parallel group Phase III study with about 400 patients each. These are designed to evaluate lebrikizumab as monotherapy in adult to adolescent patient. Adolescent patients means age 12 to less than 18 years of age and weighing at least 40 kilograms, both with moderate-to-severe atopic dermatitis. Both studies have an induction period of 16-week, treated with subcutaneous lebrikizumab 250-milligram every other week versus placebo followed by a maintenance period of 36 weeks, which will test both lebrikizumab every 2 weeks and every 4 weeks versus placebo. This study excludes participants that have been previously treated with either dupilumab or tralokinumab, so includes only biologic-naive patients. Today, we cover the results of the every 2 weeks dosing at week 16, and we will provide further details on the every 4-week dosing at the time the week 52 results will be available. The primary endpoints were assessed as we've seen in the 2 studies and were measured by an investigator global assessment, IGA score, of clear or almost clear skin with a reduction of at least 2 points from baseline at week 16 and an at least 75% or greater change from baseline in their Eczema Area and Severity Index, EASI, score at week 16. In addition, various secondary endpoints are determined. In the ADvocate 1 study, this is now shown on the next slide, 59% of patients treated with lebrikizumab achieved at least 75% skin clearance EASI-75 at week 16, compared to 16% of patients treated with placebo. Statistically significant differences between patients receiving lebrikizumab and placebo were observed as early as week 2 for EASI-75. In the ADvocate 2 study, 51% of patients treated with lebrikizumab achieved at least 75% skin clearance at week 16 compared to 18% of patients taking placebo. Now let's look at IGA co-primary endpoint. In the ADvocate 1 study, 43% of patients receiving lebrikizumab achieved clear or almost clear skin at week 16 compared to 13% of patients taking placebo. In the ADvocate 2 study, 33% of patients treated with lebrikizumab achieved clear or almost clear skin at week 16, compared to 11% of patients treated with placebo. Significant improvement were seen within 4 weeks. On the next slide, we look at secondary endpoints. Secondary endpoints included the proportion of patients achieving EASI improvement of at least 50%, 75% or 90% from baseline. The percent change in the pruritus numeric rating score with an improvement of at least 4 points. Change in sleep loss from baseline were also measured. The data shown on this slide indicate a good response in EASI-90 with 250-milligram lebrikizumab every 2 weeks. Regulators require IGA assessment and EASI-75 as primary endpoints, but EASI-90 is a very high hurdle to overcome, and we're very happy to see those results. On the next slide, we will move to itch. Itch, which is the most prominent symptom strongly affecting patients' quality of life, was measured by the Pruritus Numerical Rating Scale. Lebrikizumab improved each method by more than 4-point improvement versus baseline in the Pruritus Numerical Rating Scale in 46.3 and 38.3 of patients, respectively. These data reinforce lebrikizumab's ability to address one of the most debilitating and highest reported symptoms of patients with atopic dermatitis, namely itch. If you go to the next slide, in addition, improvement in sleep quality measured by an improvement of more than 2 points on a numeric rating scale was seen in patients treated with lebrikizumab. This again is something really important for patients. Finally, and this is on the next slide, atopic dermatitis carries a high burden in terms of quality of life, which was therefore also measured. Dermatology health-related quality of life costs were determined by the first on-treatment assessment at week 16. Lebrikizumab improved quality of life in a rapid dose-dependent manner, compared with placebo in 75.5 and 64.4 patients, respectively. This suggests that patients experienced a rapid improvement in quality of life pyramid. Moving to the safety profile. The overall safety profile at week 16 shows that lebrikizumab was well tolerated with an overall incidence of adverse events comparable to placebo or even lower. This is consistent with prior lebrikizumab studies in atopic dermatitis and similar to other targeted biologic therapies in that space. Patients taking lebrikizumab compared to those on placebo reported a lower frequency of adverse events in both ADvocate 1 and ADvocate 2. Most adverse events across the 2 studies were mild or moderate in severity and did not lead to discontinuation of treatment. The most commonly reported adverse events are conjunctivitis, nasopharyngitis and headache. In summary, we are very excited about the week 16 data I just presented, and we believe this underscores the potential of lebrikizumab in atopic dermatitis. As shown, the data at week 16 from 2 pivotal Phase III trials suggest that lebrikizumab every 2 weeks is efficacious for patients with moderate-to-severe atopic dermatitis. Importantly, lebrikizumab demonstrated rapid efficacy in primary and key secondary endpoint. Statistical significance was achieved in key endpoints as early as week 2 with a very good safety profile. These results provide further evidence that IL-13 is a key pathogenic driver in atopic dermatitis. We look forward to continuing our collaboration with Eli Lilly on the lebrikizumab clinical development program and are excited by the prospect of delivering this promising therapy to people living with moderate-to-severe atopic dermatitis in Europe. With that, I'll pass back to Gianfranco.

Thank you, Karl. And let me walk you through our peak sales assumptions. Atopic dermatitis is an underserved and large growing market, estimated to have about 5.5 million moderate-to-severe patients in Europe by 2026. Out of the moderate severe patient group, we estimate that a meaningful share will be treated with new systemics, which suggest at least 500,000 patients. One similarity with the psoriasis market is that we expect patients and physicians to use a number of medicines, and we believe biologics will establish a meaningful share. Within the biologics share, we remain confident in lebrikizumab competitive profile. Currently, there are only 2 biologics approved for moderate-to-severe atopic dermatitis, thereby giving Almirall unique opportunity to help the patients with atopic dermatitis live a better life. We will also note that unlike in psoriasis where the primary goal of treatment is skin clearance, we believe that atopic dermatitis is more heterogeneous and therefore do not expect a linear treatment algorithm as more treatment options became available as clinical aspect like immunophenotypes, emotional, physiological, physical impact and patient preference can vary broadly. There remains a large unmet need to provide new option to patients. And therefore, several medicines are needed to meet the diverse range of patient needs. We will wait until we have the full 52-week data, which will be more meaningful to understand the profile and to review the market, which is changing favorably. And now let me wrap up. As we said, lebrikizumab is one of our most promising assets and will be one of the several new growth drivers in Almirall's playbook over the next few years. The Phase III study so far confirms that lebrikizumab may potentially offer a compelling combination of efficacy and safety, reinforcing that our belief in lebrikizumab has the potential to be the leading treatment option among the new generation of biologics. Our confidence in lebri followed a strong clinical profile that is emerging and specifically, with significant improvement in more than 50% of the people treated achieve at least 75% improvement in the overall disease severity at week 16, as measured by EASI-75, and with a fast onset of action in as early as 4 weeks. We expect to compete the -- to complete, sorry, the ongoing ADvocate 1 and ADvocate 2, 52 weeks maintenance studies in the first half of the year. We are optimistic that the 52-week result from ADvocate 1 and 2 will further demonstrate that lebrikizumab can provide much needed relief for people who struggle from this chronic lifelong disease. Week 52 maintenance results from ADvocate 1 and 2 as well as data from the other ongoing study in the Phase III clinical trial development program will provide more information, and we are still hopeful to differentiate with the every 4-week treatment. Physicians consistently report the need for new treatment because atopic dermatitis can vary greatly from person to person. In short, we feel lebrikizumab has a competitive profile. And we plan regulatory filings with EMA in the late 2022, and we would expect approval about 1 year later in late 2023. Finally, Almirall is well positioned for long-term growth by unlocking the value of the late-stage pipeline. Our focused strategy on the medical dermatology space position us well in the midterm. We are going to continue to execute on our strategy, transforming our portfolio with a series of exciting and innovative pipeline assets that support our future growth prospects. And with that, Pablo, I will now hand back to you for the instruction on the Q&A.

Thank you, Gianfranco. Nadia, back to you for the Q&A, please.

[Operator Instructions] The first question comes from the line of Emmanuel Papadakis from Deutsche Bank.

So perhaps I'll take two. One on just the European commercial market opportunity relative to U.S. It's notable that atopic dermatitis commercial development has been very U.S.-focused so far. So do you think there's any specific barriers in Europe that are preventing it more closely tracking the commercial development of the U.S. atopic dermatitis market? Or is that just a matter of timing, for example? And perhaps you could just help us with the timing of likely major reimbursement post the late 2023 launch. And then just a question in terms of clinical positioning. Are you really intending to position this as a first-line -- frontline therapy to compete head on with dupilumab in the frontline? Or would you do it as a switch refractory option and perhaps a few comments on price accordingly, pricing strategy.

Okay. So let me start with the commercial, and then I will hand over to Karl from a scientific point of view. So we are -- as you can imagine, we are very thrilled with the data of the 16 weeks, but we want to be very careful, and we are working on several assumptions, and need to wait for the 52-week data. In terms of pricing, that will be, for sure, determined by the -- by our labor and by the data that we are going to see. And we needed to just wait. And as we said, we are working on different level of assumption. We feel the market is growing. We are very happy with that, but give us some time and we'll be more precise with you in the months to come. Maybe, Karl, you want to comment on the scientific part?

Yes. Now with ADvocate 1 and 2 and the 52 data and the ADhere study, these are main regulatory studies to enable approval and the label. In terms of ensuring access and pricing in Europe, we have already started a Phase IIb study called [ADVANTAGE]. This explores lebrikizumab in combination with topical corticosteroid in patients, adults and adolescents, with moderate-to-severe atopic dermatitis that are either not adequately controlled with cyclosporine or for whom cyclosporine is medically not advisable. This is a study that has started in last December and will be sized at around 300 patients with EASI-75 that we've seen as major endpoint. In addition, we are considering doing then head-to-head studies against available therapies. This is an ongoing discussion, and we'll further update you, now thinking once the complete data package is available. As you know, we're still looking forward now to the 52 weeks data in the first half of this year.

The next question comes from the line of Thibault Boutherin from Morgan Stanley.

Maybe my first question is on the kind of marketing message you can think of right now based on this data. Because from what we can see on the 16 weeks, I mean, it looks as good as Dupixent. But the thing is we don't see major points of differentiation. So just when you send your sell reps -- sales reps out there, what kind of message you can give to try to differentiate lebrikizumab as a treatment option. And also in relation to this, what is your confidence that this drug could be useful in second line given that we the mechanism of IL-13 is the same as Dupixent. So what confidence do you have that can be used for the second line? That's my first question. Second question. Just if you could talk a little bit on your expectations for the monthly formulation every 4 weeks. How kind of -- the degree of confidence you have at this stage that this could be a proper dosing option and that it could bring differentiation to our products.

Maybe I can start and then Gianfranco can continue. So first of all, we believe that the 16-week data show that lebrikizumab has a very competitive profile, both in terms of benefit efficacy, but also in terms of side effect profile. And as mentioned, the atopic dermatitis market is growing. There is still a strong need for alternative in that market. To now fully understand the profile and all the characterization, we need to wait for the 52-week data, which then also will inform on the every 2 weeks and every 4 weeks scheduling options we may have, and we will update you once those data are available.

Yes. I think that you covered it, Karl. We are working -- we are discussing internally on different angle of differentiating versus dupi. And the 52 weeks data is going to help us to clarify this one. So I think that Karl already covered the question.

The next question comes from the line of Guilherme Sampaio from CaixaBank.

Apologies. The first one was already answered. So any development in the definition of the next steps in terms of reimbursement studies, namely if there's going to be a head-to-head with dupi. And second, do you maintain your view after this data that JAK inhibitors could have a higher penetration in new systemics versus biologics in atopic dermatitis despite the toxicity issues that you presented?

Maybe I can start and you can comment on the JAK inhibitors, Gianfranco. I mean, as I said, we have started now the [ADVANTAGE] Phase IIb trial. This is one of the studies that also has been done by tralokinumab and Dupixent in patients that are either have failed on cyclosporin or are not medically advisable to take cyclosporin. This is one element. And the second element, as mentioned, is a consideration doing head-to-head studies versus standard of care. And this is an ongoing discussion as we still not have yet the full data set as mentioned.

Yes. JAK question, you know that the JAKs both in the U.S. and in Europe, the regulatory agency are assessing the risk/benefit profile. And particularly, they are looking for the safety and it's very early for us to speculate. So let's give the regulatory agents the time to perform their job, and then we can be in a much better position to assess what will be the potential in the atopic dermatitis market.

The next question comes from the line of Elizabeth Walton from Credit Suisse.

I've got a couple. Firstly, just looking at the efficacy data, it looked like you had a slightly lower benefit in the ADvocate 2 study, some discussion at the conference that might have been driven by a higher proportion of rest of world patients enrolled. I'm just curious if you'll look to present subgroup analysis by geography at some point in the future. And my second question is on safety. There was some perhaps disappointment that the conjunctivitis signal is slightly higher than in Phase III than what we saw in Phase II, and that was a topic of potential differentiation versus on-market biologics today. KOLs at the AAD meeting noted the need for a head-to-head study to truly understand there is a difference between drugs here. I'm just curious, you mentioned the possibility of running a head-to-head study for reimbursement purposes in Europe. Are you able to tell us if this is something that we'd be looking at comparing safety with a noninferiority sort of efficacy endpoint? Or what might you be looking at there? And then just lastly, I know people have already brought up the topic of pricing. I'm not expecting you to comment on your pricing strategy, but more trying to understand if Almirall has complete freedom to price as you'd like to in Europe, given the shared right -- if there is a possibility to undercut Dupixent pricing in Europe specifically?

Thank you for your questions. I mean, on the first point, the difference between the efficacy data on ADvocate 1 and 2, it is correct that in ADvocate 2 we have slightly more Asian patients as a population, a couple of percentage points. We have very carefully analyzed all the data because, as you can imagine, we were also a little bit surprised by that result. But at the end of the day, based on the data that are available today, we rather think that this clinical trial variability that we see here, rather than any effect on, for example -- and based on the country or ethnic composition. As said, this is our -- based on the data today. And when we have the 52-week data, this may then further evolve. On your second question around why is the conjunctivitis rate slightly higher in Phase III as compared to Phase II, perhaps a couple of considerations. The first one that we had a slightly different and larger patient populations. That is one thing. I think the second thing is that now with having more biologics in the markets that we're ahead of had also the awareness of conjunctivitis is, of course, growing. At the same time, I think if this is still a low rate and can be well managed. And whether this is an area of differentiation with potentially studying this in head-to-head against other available standard of care, that is an ongoing discussion and is amongst the various considerations we have.

Yes. In terms of pricing, you were asking our strategy. As we already said, we are working on several assumptions, but let's wait for the 52 weeks data and then we are going to make it -- to decide to make it public. But for the time being, I would prefer not to answer to this question. Thank you, Elizabeth.

[Operator Instructions] The next question come from Alvaro Lenze from Alantra Equities.

The first one, if I am not mistaken, you have mentioned that you're seeing some dose-dependency efficacy, but we only see the data for the 1 arm with the same dose of 250 milligrams every 2 weeks. So could you please clarify where do you see dose dependency or whether this is from interim data from the 52 weeks trial? And the second one would be regarding guidance. It remains unchanged even though since you first provided the guidance, the JAKs look like a much more pricing threat the labels that they have gotten in the United States seem to indicate that they would be second line after biological treatments or other systemic treatments. So I wanted to know whether there is any specific reason for you not changing your guidance. I don't know if you see a different size in the market or just this is out of your [indiscernible].

Yes. So I'll take the first question. So really, thank you for listening very carefully and actually spotting that this is every one dose tested, and it's not a dose dependency. I just realized that I was really that -- so sorry for that little slip through for that. So we don't want to speculate on any other dosing schedule, but we saw at this dose really a rapid improvement in terms of quality of life.

Yes. And in terms of guidance, you are absolutely right that the market is moving a lot, but we won't take our time to see the data -- I repeated several times -- of the 52 weeks. And then we are going to come back with our final guidance. But for the time being, we are observing very careful all the movements on the market and that we need to wait for the final data. Thank you, Alvaro.

The next question comes from the line of Jaime Escribano from Banco Santander.

So one question from my side, which has been kind of asked, but maybe in a different way. So from The data, what is -- what -- where you are more excited about lebrikizumab, what from the primary and secondary end points what is the data that for you is more encouraging, for example, versus Dupixent? And also building on this question the other way around. Is there any data that is below expectation or that is below that of the Dupixent? So what would be, in other words, what would be the weakest point of leverage when comparing to Dupixent?

Yes. I think let me get started on that. First of all, there have been so far, no head-to-head studies being confirmed. And therefore, we cannot really compare data because these cross-trial comparison are really, really challenging and difficult, yes? When you ask me what is most exciting about lebrikizumab is clearly the consistency of the data, so that we meet the primary endpoint, all the secondary endpoints, all the data going into the right direction. When you look at quite a range of parameters that we measure where we all see a very significant and substantial benefit. It's this overall profile of efficacy, but also with what is overall a very good safety profile, an antibody with a high bioavailability with a low dosing that is really, from my perspective, really has the potential to be best in class. I think, at this stage, I have to say I don't see any kind of a downside or things that would have disappointed us. I think what we always have to bear in mind here that there is always this question about what are the real drivers. And I think those data also from an overall perspective, support the notion that IL-13 is this cytokine that drives atopic dermatitis. And if we address this very specifically, this will lead to a very substantial benefit for patients.

There are no further questions. I would like to hand the conference over to Pablo Divasson.

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