Good morning. Good afternoon to all of those attending this MoonLake webcast. My name is Jorge Santos da Silva. I am CEO and Chairman of the company, and I am accompanied here today by my Co-Founder, and Chief Scientific Officer, Kristian Reich, and by our Chief Financial Officer, Matthias Bodenstedt. In today's session, we're really going to focus on HS, our main indication in dermatology. We will start off with a brief introduction just to make sure that everybody on the same page, but also to make sure that the key messages are delivered early on, as they are very strong and important for the company and for sonelokimab. Kristian will take us through that, looking at the final data of what is arguably the largest program in HS today. I remind everybody that this program is composed of four trials that will be important for the registration of the product, starting with a comparative trial, MIRA, where we compared ourselves to the standard of care, HUMIRA and placebos, the two large VELA studies, where we tested our main dose versus placebo over time, and of course, a trial that is very dear to us, the VELA-TEEN trial, a trial that covered also adolescents, a first also in HS. Once we've been able to look at all this data together, I will take it back to recap how we're going to follow our label strategy and our BLA submission following all the conversations we've had with the FDA, and now in possession of the full data set. Matthias will take us to a very important part of the story, which starts looking into what happens next, which is really thinking about how we're planning to commercialize the product and where we are in this process. I will take over at the end for some closing remarks. We will of course, as always, open for a Q&A session. For those that are less familiar with our story, I just want to make sure we spend a couple of minutes telling you a little bit about the company and a little bit about our asset. MoonLake is a company that is now five years old. The company was founded focusing on a single asset, sonelokimab, which we always felt was a very interesting molecule that really needed to be developed for patients, as it inhibits IL-17A and IL-17F, a very critical axis of inflammation in many diseases, but also because it's the opportunity to introduce a very exciting new technology in terms of therapies for patients, the nanobodies, these very small molecules that retain many of the characteristics of antibodies but have several advantages that I'll go over. The company went public in Nasdaq in 2022. Obviously since then, we've been able to raise a lot of money to develop all the indications that we're pushing for as we develop sonelokimab as really a pipeline and a product. In fact, we've now completed the phase III results in HS. That's what we are also discussing today. Many of you know we are in phase III for rheumatology indication with psoriatic arthritis. We have other indications that we are developing. Very importantly, the company is transitioning to its next phase of growth as we plan to submit a BLA for approval towards the end of Q3 this year for a launch next year. That's a little bit about MoonLake. Again, for those less familiar, I just want to spend a couple of seconds here talking about the molecule and reminding all those that are more familiar how important it is to introduce new technologies into therapies for patients. As many of you know, the nanobodies take advantage of something that nature created, which is heavy chain-only antibodies that have a far less complex variable region, if you allow me to say that, versus human antibodies. The ability to take this less complex variable region allows us to really target important molecules in medicine, but do so with very small domains, these VHHs. The other interesting element about these elements is that you can actually put several of these VHHs together, which is the case for sonelokimab, as you can see on the right side of the page. We are able to target different elements that are important for therapy while maintaining a very small size of the molecule. In the case of sonelokimab, this means that we are able to target IL-17A, IL-17F, two very important MOAs in inflammation, also target other elements. In the case of sonelokimab, able to target albumin, which allows the molecule not only to be a little bit more stable over time, but to travel to sites of inflammation. All of this is possible while maintaining a very small size. Just to give you an idea, sonelokimab is about a third of the size of a normal monoclonal antibody. Very exciting technology, very exciting MOA. MoonLake, as I said at the beginning, is now approaching registration. The company really focused the development of sonelokimab along two therapeutic areas, as you can see here on the page. We focused on dermatology and on rheumatology. The reason for this is we see vast opportunities to change the lives of patients, huge unmet needs, but obviously also interesting opportunities in terms of market size. To achieve that, we started developing different indications along these two therapeutic areas. As you can see there on the top, the first two lines, hidradenitis suppurativa now completed phase III, now moving on to registration. That's where we'll spend a lot of time today. We'll also include in this discussion the second line that you see here, which is the progress that we have done with adolescent patients suffering from HS. Also, this will be part of the registration. Today, we will not talk too much about the other indications that we're developing. I'll touch base on PSA at the end, because as you can see there, that's also a phase III that is ongoing, and we are approaching the primary endpoint on one of these trials, but I'll touch base on that at the end. Today, really the focus is data-wise on the top two lines in HS. The interesting thing is, as we've been developing these indications through phase II to phase III now to registration, I think there's one trend that I think is quite apparent. That is that sonelokimab is a drug that really has a leading profile in any of these indications. I won't go through the details that you see on this page, as you can see here, when you look at key primary endpoints at different phases of clinical development, if you look at the endpoints that we actually target, which tend to elevate from previous trials done before us, what you really see is a level of efficacy that really shows a leading profile across all indications. All of this together with a safety profile that we believe creates a very unique benefit ratio for patients, but also a very convenient drug. Oftentimes, biologics need a lot of injections, very regular injections, painful injections, not only we have efficacy and safety, but we also do this in what we think is a very convenient dosing for patients across these indications. Once again, taking opportunities that are presented by nanobodies when it comes to formulation. A very good profile. As you know, 2026, as all the other years before that, have been catalyst-rich for our company. As you can see here in the grayed-out part to the left, all the things that we've already put out this year, which include a lot of new data and presentation at scientific congresses, as keynote presentations. You can see to the right side of the page, all the things that are still to come this year. As you see there in the sliver in the middle today, we really focus on the phase III readout or the 52-week readout for VELA as it completes the HS package. You will also see that after that comes IZAR-1 on rheumatology. Again, I'll come to that at the end of the session. If there is one slide that we would like you all to retain, this is probably the next slide. The key message that comes here is we truly believe that SLK is on schedule to be a potential best-in-class drug in HS, probably a best-in-disease drug for this important indication. Not only we believe that, but the facts are really starting to stack up to support that. For example, in terms of efficacy, what you will see today is that the drug really leads across several elements of efficacy. I remind everybody that all of these have been elevated from previous trials. Very well-known fact that before, still, drugs are developed in phase III with HiSCR50, a 50% improvement in the disease as primary endpoint. We've elevated that for HiSCR75, we do so across many scores of efficacy and across many time points. Just some facts here to already start shedding light on what the data you're going to see. You can see that on our primary endpoint, HiSCR75. After one year, 67% of the patients have reached HiSCR75. 67% of the patients, which is obviously almost 70% of the patients here. A very interesting score. By the way, for those that are a little bit younger, this is a very easy number to remember. It's a six and a seven. Six seven, you cannot forget this name. Very interestingly, also 1/3 of the patients reach not only HiSCR75 but HiSCR100, and one in every four patients reaches what we call inflammatory remission. That is, there is no abscesses, no nodules, no draining tunnels. This is a target that I don't think was even in people's minds a couple of years back. We believe that there's now a very good path for us to not only show good long-term data, but to have a very good delta to placebo in our label at the primary endpoint of week 16. Really the card of efficacy, I think, is being played very strongly here. Together with this comes what we believe is an advantageous benefit ratio, very rapid onset of response, but with a safety profile at week 16 that looks very promising with no SIB, no liver signals, no IBD, and other advantages, not only versus placebo, but obviously versus competitors. As you will see, a very consistent safety profile long term, which we believe very important for prescribers. We also believe that SLK will now have a broader label in HS. As you know, and as I've mentioned, we're the first company to do a dedicated clinical trial in adolescent patients with VELA-TEEN. It was the first molecule being tested here, and I'm very happy to report that we have great efficacy. For example, about one in every two patients reaches HiSCR100 at six months in this trial with no new safety signals for this population. That obviously is very important for us. A broader label on top of efficacy and safety, but also on top of that, improved convenience. As you know, we have a very, very convenient induction protocol with very few injections. Our injections are very fast compared to competitors. On top of all of this, and I think this is really important also for dermatologists, also for KOLs, really starting to move the boundary here, with a very unique mode of action. The way we inhibit IL-17A and IL-17F is unique, even versus the only other competitor that does that, but also a new technology that opens other opportunities for patients and physicians. If you actually take one message, take this message. No matter where you look, the profile of SLK really seems to indicate a potential best-in-class drug. That said, that's it for the introduction now. I will pass it over to Kristian to really take us through the final HS data package. Kristian. Thank you very much, Jorge. Also very warm welcome on my side. I was just looking at your slide, founded in 2021. Now we sit here and I have the pleasure to present indeed what will be the final data that will constitute the core of what we will submit in our BLA. I remind you, just going back to the disease. I remember when some years ago we talked about this is very frequent, the prevalence may be as high as psoriasis. I think many people had question marks, and these question marks, in my eyes, have completely disappeared. Now we see an increased awareness. We see that patient organizations are getting more active, companies are getting more active, the dermatologists are getting more active. We can already really see that this prevalence and the data that we can analyze approaches this 2% mark that we were always talking about. Matthias will chat about the fact that this awareness already leads to 300,000 patients being newly diagnosed in the U.S. every year. That's actually, sadly, higher than the number of patients that are newly started on a biologic. There remains a high unmet need in this important chronic inflammatory skin condition. You know that I'm a dermatologist, so I've really seen many of these patients. This disease is unfortunately characterized by the fact that not adequately controlled inflammatory lesions progress to irreversible tissue damage that is kind of unique to this disease compared to other chronic inflammatory skin conditions. You have this formation of draining tunnels. You have the formation of scars. What does this mean? We should be highly motivated to control the inflammation as early, as good as possible, with an eye on having a positive influence of the course of the disease. Jorge already talked about the adolescent trial. I think this was a big motivation for us to actually go into juvenile patients with HS. It is a disease that has different phenotypes. You have inflammatory lesions like nodules and abscesses. You have draining tunnels. You have these irreversible lesions, the tunnels, the scars. I will come back to this when it comes to how do we actually measure the disease and what are also some potential limitations. What is shocking to me and I think to everyone working and interested in this field, is that it still takes up to seven, in some cases 10 years before the diagnosis is properly made. That is the delay between the first onset of disease signs and the proper diagnosis. Of course, we really need to be better than this. If we want to not miss this window of opportunity that we will hopefully have with better and better drugs, anti-inflammatory drugs in the future, we also need to be better in making the diagnosis early on. Last but not least, there are now a few modern drugs approved. What we hear when we talk to patient organizations, that those patients with significant moderate to severe HS, many of them have already cycled through the disease treatments that currently exist. Every company will say there's an unmet need. We believe there is really an unmet therapeutic need in HS still. It's a pleasure for us to present the data from the studies, I will talk about our phase III program in a second, to present the data to you that will hopefully lead to the approval of a new, and potentially, I think, best-in-class, maybe best-in-disease drug, in this important skin condition. What was our phase III? Two identical trials called VELA-1 and VELA-2. We put this phase III program on top of a pivotal-like phase II study. Again, I will come back to this. We did our dose-finding work in phase II. In phase III, we could clearly test our best dose, the 120 mg, versus placebo. As you see here, primary endpoint at week 16, all placebo patients being rolled over to get active drug. As everybody else, you submit in your BLA what we call the parental trial data, and that is one year. That is what we will talk about today. I also remind you, these are chronic diseases. These patients will not only get, hopefully, these drugs for half a year or a year, but for many more years. We have an open label extension program that runs an additional two years on top of the one-year parental trial. Already to water your mouth, this will also include our adolescent patients. We will be able to see over one, two, three years how well adolescent patients are doing on sonelokimab. Jorge already talked about the fact that we wanted to use our clinical development program to also elevate outcomes. We wanted to understand how good is the drug in bringing patients to HiSCR75. We looked at HiSCR50 as well in order to allow comparisons to other drugs. Just to start talking a little bit about limitations, HiSCR, as you know, measures the reduction of two inflammatory phenotypes, the nodules and the abscesses. It does not measure the reduction of draining tunnels. This is why we decided to add another lesion count, if you will, into our program, the IHS4, which actually quantifies the decrease of all three types of inflammatory phenotypes in HS. Very importantly, we really do think that HS is a lot more than counting lesions. When we talk to dermatologists, my own experience, when we talk to patients, the patient organizations, we get the uniform answer that what really drives the disease, what matters, what constitutes the disease burden, is not so much counting lesions, it is the pain. It is the odor. It's that you have to change your dressings, that you cannot lead a normal life. You cannot do your sporting activities. You have problems with social interactions. This is why, for us, it was very important to include patient-reported outcomes that measure this real disease burden into our phase III program, which we see are a very conservative read on pain, and then the HiSQOL, a health-related quality-of-life instrument specifically validated to measure impairment in HS. It's a disease-specific, health-related quality-of-life instrument. We also put in the DLQI, a generic instrument that measures impact on quality of life across skin diseases, just to have a validation of the findings. These are two large studies. Actually, I think this is the phase III program that has exposed more patients to the dose that it seeked approval for than any other phase III program, and that is driven also by this very straightforward design. You know the results. This is the findings at the primary endpoint. This is the week 16 findings. I think we were very happy to see across what we call pivotal-like trials, so adequate, well-controlled studies. That is what you see here. Very happy that across all three trials, MIRA, with more than 230 patients, VELA-1, VELA-2 with more than 440 patients in each of these studies, we saw a consistent higher response to sonelokimab. You see the numbers here. These are the HiSCR75 responses. We also saw a consistent placebo response with the exception of VELA-2. Of course, you know this was the inconsistency. I personally, after many discussions with leaders in the field, we have done so many additional analyses, as you would guess. We see a very high quality, a very high validity of our clinical trials. I speculate here, but I think that the way the HiSCR is constructed, it will be subject to some impact of placebo, maybe driven by nodules, maybe driven by other factors. We would not be surprised if we see more and more studies in the future where you have these outliers in the placebo response. An outlier in placebo is not an outlier in the response to active drug. This was very consistent, by the way, very consistent, not only when it comes to lesion counts, but even more consistent when it comes to these important PROs that I was talking about, like pain and HiSCR and others. I said it, more than 500 patients exposed to the dose we seek approval for, and a very simple measure, I think a first look into how safe and tolerable the drug is the dropout rate. Now let's talk about the one-year data. Let's start to talk about the end of the parental trial. We see across our one-year study, we see a dropout rate as low as 26%. HS patients are complicated patients. They are sick patients. They have many comorbidities. Many patients have many other significant medical conditions. Many are on many other drugs. I think a dropout rate over a one-year period of 26% speaks to a favorable safety profile and a good tolerability of the drug. As I said, we are interested to collect more long-term data. We really want to show the world, because this is a chronic disease, how good is our drug not only after one year, but after two and after three years on our approved dose. For me, I'm delighted to see that almost 90% of the patients we enrolled in the study at baseline actually roll over to this open-label extension period. There will be very interesting long-term data to come that should be very informative about how good is the potential of this drug to really do what this drug should do in a chronic disease, and that is delivering a safe long-term control. Of course, this is the slide that we have printed out as a poster, and now every MoonLake employee has hung it on the wall. This is putting together the drugs that are in phase III or are approved in HS and that have finished their parental trials. This is what this slide looks at. These are the parental trial data of bimekizumab, of secukinumab, of povorcitinib, and of us. You see the color codes. We present the first 16 weeks. All these studies had week 16 as their primary endpoint. We present the first 16-week data using the method that was selected to measure the primary endpoint. Uniformly, beyond week 16, we show the data as observed. I think it is an as apples-to-apples comparison as you can do it. You can see the very fast pickup of the response, HiSCR75 with sonelokimab. You can see the great response in the long run, numerically producing the highest number, I think, that we have so far seen in a phase III program of this type. Seeing that 70%, seven out of 10 patients after one year achieve a HiSCR75 response, I think is very good news for patients, for KOLs, and for the world. You can see that there are really differences between these drugs. I think it was important for us to get confidence that our drug has this potential to be the leading drug in the disease. Importantly, if you have a placebo wrinkle, allow me to call it like this, at one time point, in one endpoint, in one of your studies. Is there something wrong with your placebo patients, or is your drug actually providing, irrespective of what the placebo response was, a similar amount of benefit? That is what you see here. This is why we decided to bring this slide. You see that the placebo patients that cross over to sonelokimab, irrespective if they come from VELA-1 or VELA-2, they achieve the same benefit. They achieve it fast. Within four weeks, they actually catch up to the response curve of the patients that started with sonelokimab at baseline. For those of you, and I know there will be some that will analyze in every time point, I can tell you it's amazing to see how similar the response after 36 weeks of exposure to SLK is, because this is what we show you here. If you compare this to the response you see after 36 weeks of exposure to those patients that get the drug from the beginning, it's identical. I think this is not only a very strong validation of the findings in VELA-1 and VELA-2, but it's actually confirming this response that I already showed you for the active arms before, and also confirming that there is nothing wrong with the drug and nothing wrong with the placebo arms, and that these placebo patients that we saw have an identical response to each other and to the patients that received drug from the beginning. Now, let me do this now a little bit as a prescriber. Allow me to do an exercise with you. Now, imagine you are a doctor that is interested in treating patients with HS, and you have these several drugs now, and you have a patient sitting in front of you that you consider a candidate for an IL-17 inhibitor. What you probably do in your mind is that you create these scorecards where you look at all these outcomes, the lesion counts, we discussed this, the lesion counts that include measuring the decrease of draining tunnels, including these important PROs. You create the scorecard in your mind because you want to understand which is the drug that gives my patients the highest chance to respond. Which is the leading drug? I think you will understand that all prescribers do this exercise, whether there is a formal meta-analysis or not, that's what you need to do as a prescriber, and we try to do this. We try to do this here in the best possible way using the data that is available. We used here the data from Be Heard because we consider the IL-17A and IL-17F antibody as the so far best drug in HS. You see by the color code here, if you do this scorecard approach, I think you cannot escape the notice that sonelokimab really has the potential to be a leading drug. I think not only best in class, but actually best in disease, if you consider that bimekizumab is leading the pack as we speak. I think what you also see here, and that's a little bit a different exercise. We always compare responses, and we look at the percentage points. This is, of course, a little bit of an artificial analysis when you want to answer the question: how many more patients benefit from using drug A versus using drug B? This is the kind of analysis payers are interested in. This is the kind of analysis you do when you do a health technology assessment. We allowed ourselves to put this column in to answer these questions, how many more patients would benefit from SLK? We show you the percentages here. For many of the important outcomes, you see that the differences reaches a double-digit percent number. We just put one here, this IHS4-100, which is very important for us because as Jorge said, we think it indicates inflammatory remission. Really cooling the fire, if you allow me to use this metaphor, that HS is to really put this fire out, you see that 10% more patients benefit from SLK when you look at this inflammatory remission compared to the existing IL-17A and IL-17F inhibiting antibody. I think the scorecard looks very promising when we go through all these different efficacy endpoints, you saw that this includes the PROs. This includes pain. This includes HiSCR, the things that we believe may matter even more for patients than the lesion counts. I know that is rarely done. I present these two slides now, the week 16 and then the one-year data, also as an attempt to reflect the scorecard exercise that prescribers will do. As you are very aware, we tend to look at certain safety events of special interest. We tend to look at liver. We tend to look at IBD. We tend to look at suicidality, other things you see reflected here. Again, this slide is an attempt to do an apples-to-apples comparison as much as possible. We think not only at week 16, but importantly, also at the one-year mark, the end of the parental trial mark. You can't escape again the notice that sonelokimab combines this high efficacy data that I was showing you with a very favorable safety profile. I think this is what matters for patients. Of course, it also matters for prescribers. It matters for dermatologists. We think it was important to put this side by side. Extremely promising efficacy and safety data from the one-year parental trial data for sonelokimab. Jorge talked about the adolescent patients. Again, allow me to be a little bit emotional. You can always say, "Yeah, we need to change the course of the disease, and we need to treat inflammation in HS early on." You need to do a study to show that your drug is able of doing this. We decided to use sonelokimab in a trial with adolescent patients from 12 years on with HS. An important first outcome of the study is the PK, is the drug when you dose these adolescent patients, is it behaving identical to adults? If this would be the case, then you can assume that all the data that you generate for adults are somehow transferable to the adolescent patient population. I apologize for the complexity of the graph here, but what you should compare is the green and the blue. This is showing you in green the PK data we observed in adults, and in blue, the PK data we observed in this study in adolescents. I think you can clearly see the drug behaves the same. By the way, the drug behaves very well. You see that these confidence interval are very narrow. Again, you see no difference between these adolescent patients from 12 years on and the adults. This is an important formal hurdle to jump over, and this was the primary reason we did the study. We look at efficacy, and you see the efficacy here. In the dark blue bars, you see the efficacy obtained in adolescent patients. For reference, with the white dots, we put in the numbers we saw in adults. Great response in adolescent patients. These patients could be enrolled with not yet having a tunnel. We really enrolled the patients to put this question to the test. Can this drug potentially positively influence the disease course? I think when you look at these numbers, at week 16, 80% having a response if you use HiSCR50 to define response. More importantly, at week 16 and then at week 24, 60%-70% of the patients achieving HiSCR75, and high numbers achieving HiSCR100. You know what this also tells me, and we have seen this in other chronic inflammatory diseases, the longer you wait to treat, the lower will be your response. In my own words, if you save your best drug for last, your last drug is no longer the best. This data is showing you this. It shows you that if you use sonelokimab early on in adolescent patients, you have a better chance to control the disease, and will be super interesting to see the long-term data. How are these patients developing over years under treatment with sonelokimab? The safety profile in adolescents, very clean. Many would perceive adolescent patients as a potentially more vulnerable patient population, it's important to see that the safety profile is as clean as we saw it in adults. Last but not least, coming back to one other practical consideration. That is rarely talked about, but when you sit there in the practice and you give the first auto-injector, or you train patients to give the auto-injector, you will realize that it does matter. We think we have a very convenient way of administering sonelokimab. We have a very well-used and established auto-injector. We have a very low injection volume, and this auto-injector will inject the volume in a few seconds. We achieve our maintenance dose already after five injections by week eight, and from then on, we have what we think is this very convenient once per month, 1 ml, a few second injection. Let me say one last thing. We see that, oh yeah, why not every eight and every 12 and every six months? This is my very personal view now. I think these very sick patients with HS, I think you run the risk that you lose compliance and adherence. I want to see my HS patient once per month. I do not see a convenience benefit knowing that I spend three seconds here per month to give my drug. I don't see a convenience benefit to go to longer intervals. I more see a risk that you lose the adherence, and you can already see this in the clinical trials. Taking this all together, and I hope you see the excitement level. The whole team is super excited to put all this data now together in the BLA. I hand over to Jorge to share with you what is their BLA strategy. Thank you. Thanks, Kristian. How does this all now play into what we've already been discussing with the market, with KOLs, with patient associations, the foundations, et cetera, with regards to what to expect from our BLA strategy and essentially from our label? Obviously, everything in a label matters. As we discuss sonelokimab, its strengths, and basically from a scorecard perspective that Kristian mentioned, how does it compare to others? There's essentially, in our mind, three sections that are particularly important as they will black and white reveal the value and the official value of that drug when it comes to the market. That's obviously section 14, where you see all the data around efficacy, which trials were considered, what are endpoints that we can actually talk about in the market with physicians and patients. Also two sections that in our mind relate to safety. Section five, warnings and precautions, which we know can be limiting for some drugs. Obviously the section two, how do you actually dose this when you give it to a patient? If we take a focus on these three sections, we believe that the competitor data here leaves a lot of space for SLK to compete as the leading drug, especially after you saw the data that you've seen. In this slide here, we collate sections 14, five, and two from the two competitors, one an IL-17A only inhibitor, secukinumab, and perhaps more importantly, the only other competitor when it comes to the MOA of IL-17A and IL-17F, bimekizumab. I want to call your attention to some of the elements here to illustrate this concept of space being left for us to add something more, and then I'll tell you what that more is. On top, you see the section 14 for both drugs. As you can see, obviously there's no delta to placebos in labels. There's also no P- values. As you can see, the numbers that bimekizumab presented for their primary endpoint, HiSCR50, are quite competitive, but we believe that on HiSCR75, as you saw before, there is some value left on the table, if you will, and obviously, HiSCR75 is not the primary endpoint of the bimekizumab trials. If you look at the secukinumab side, you of course see a lot of potential, but you also see that oftentimes, even if you don't meet statistical significance, even for primary endpoints, some doses are approved like that. As many people try to see what will happen to phase II data, et cetera, you don't need to look around into many other diseases in many other parts. There's a great example in HS, that is illustrated right there with Cosentyx. Plenty of space in our mind to play here for efficacy, obviously section five and section two of the other drugs, we believe also give some opportunities, especially bimekizumab. As you know, some warnings and precautions there related to safety items where we think we can present an advantage in front of regulators, in front of prescribers, and in front of patients. Quite some space. What does it mean when we look at these sections, especially the section 14 efficacy, which I know is of interest to many of you watching. How do we build this label now that we have all this data, now that we've had the unique opportunity to have quite a few interactions between primary endpoint and now with the FDA. We believe that as our base scenario, what we're going to discuss first with the FDA, we believe that we can have a label that has exactly the same dimensions as bimekizumab, HiSCR50 and HiSCR75. With a big difference again, that HiSCR75 in our case comes first because it is the primary endpoint. We believe, as we've explained, and as Kristian has already explained several times, that the two trials that will be considered here as per guidance already received and discussed with the FDA is that there are two trials that will be used to establish substantial evidence of effectiveness or efficacy, and that's VELA- 1 and MIRA. Obviously, if you look at the numbers from both trials, that presents, in our mind, a very advantageous profile for the section 14 table. We believe that our section 14 should also be able to benefit from the pain scores, the HiSCR scores, and importantly, as we said, the IHS4 efficacy scores. We believe in a base scenario, these will be presented in narrative points, so that's the text that comes below the table. As we've said before, we don't think that VELA-2 will be included as a trial in the table. They will more likely be included in narrative points in section 14. Also, it can also be included as a trial in the table. As you see, it doesn't affect at all the label. It continues to be a leading table. Just as a comparison, so that you understand when I'm saying a leading table, what are we comparing to? We're obviously comparing to our main IL-17A and IL-17F monoclonal competitor, as you can see by the numbers, just looking at HiSCR75 and HiSCR50, obviously advantageous numbers for us. Also, if you want to calculate a delta to placebo, and I would like to call your attention to the fact that our competitor does not have HiSCR or IHS4 data in their section 14, neither on the table nor on the narratives. The narrative is a very, in our mind, general comment on pain, because obviously pain did not reach statistical significance in both of the trials of that drug. We believe that the proposed base case for our label as follows the discussion, the several discussions we've had with the FDA in the last few months, really has a chance to show a label that is much more complete, much more interesting when it comes to prescribers and patients. With, by the way, a delta to placebo and primary endpoint that goes back to expectations that were in the market last year. Now we believe that there's an upside case here, where, as you can see, instead of pain, HiSCR, IHS4 being included as narratives, we might even have the opportunity to have a longer table with even more endpoints, with numbers right there in the table as an upside case, as you can see here. Obviously, this would present even more differentiation to our competitor. We don't believe that this is necessary, but this is something we will want to discuss and push for. Especially because we believe that, as Kristian Reich said, these patient-reported outcomes really need to also take center stage. HiSCR is an important measure. You're counting lesions. It's definitely important from a regulatory perspective, but when it comes to everyday life, to prescribers that are perhaps less familiar with the disease, these PROs is what really changes behavior. We're obviously very happy to have them on the narratives, but if we can put them on the table, we are going to try for that. Our base case is, as you see, that we believe that we will have a label on section 14 that is just better than other competitors. I'm not going to go through the details for sections five and two. You can read this. This document will be made available to all of you, there are several elements here, as you can see from the plethora of ticks in this page, where we believe we have an advantage over competitors. One interesting element to consider here as we think about our strategy is because we have this adolescent data, that opens the potential for a priority review for our whole BLA, including adults. Priority review from the FDA is a very strict set of criteria that clinical data needs to meet to justify the regulator spending the extra time, the extra resources to review this faster because it's important for the market. We believe that the data that you've seen is clearly pointing to our drug and our clinical data meeting these criteria. Obviously, we believe that, and we've discussed this with the FDA, that we are eligible for priority review. We've agreed that that will go with our submission in September. I want to make clear that this is not our base case. Our base case is that we follow the normal BLA procedure. We understand that oftentimes the FDA is limited in the resources it has to dedicate to these extra processes, we don't want to consider that a guarantee by any means. We consider this an upside case, but still a potential for our drug. What does that mean in terms of timeline before we go to the commercialization section? Again, I won't go through all the details. I want to make sure that you all have it in writing for your perusal. Just call your attention to the blue boxes. The first blue box there on the left, this is when we, of course, expect a submission. We've been very clear with you on that, no later than the end of Q3. As you can see on the upper part is the standard BLA process. We would expect to have the drug approved right there at the border between Q3 and Q4 next year, so that we launch then. That is our base plan. Below, you also see the blue square that talks about the priority review. If we were to be granted priority review, this would accelerate the launch of the drug by three to four months. Again, an upside case, but obviously something quite interesting for us, and a challenge also for us to deliver on this. Hopefully this is clear. You've seen the whole data. You've seen what matters in the label. You've heard us talking many times about the several interactions with the FDA, the clarity that we've put on our press releases around how this label will look like. You see now how it can be advantageous. As we go to market, either later in 2027 or earlier in 2027, we go to win. To win, we need a winning commercial approach. To discuss that, I will pass it over to you, Matthias. Thank you, Jorge. It's my pleasure now to walk you through some of the commercial considerations and tell you a little bit more where we stand with respect to preparing for the commercial launch of sonelokimab. I think four years ago, when we started talking about the opportunity in HS and talking about that this is a $10 billion+ market, most of the people were looking at us and probably not really believing what we said. You see it here on this page. We are no longer alone. I think you hear it from us, $10 billion-$15 billion market opportunity. You also hear it from our competitors and the other companies that commercialize in HS. You see it from the various research analysts that also independently assess the market opportunity. I think consensus is really now there that this is a very large opportunity. We also keep looking at claims data. Market research is nice, but I think claims data shows you the truth, and that's where we truly see right now, 2.9 million patients in the U.S. right now are already diagnosed and treated in some sort of form for HS. That's almost 3 million patients right now. Kristian talked about it earlier. We also see a substantial growth year-over-year, about 300,000 new patients being added to that. Commercially also very attractive is the very high price in HS that is linked to the dosing in HS. Most of the drugs are given double the dose that they are given in psoriasis. Here you see the approved list price of bimekizumab in HS, which is well over $200,000. Even if you look at the gross to net, this is a net price opportunity that stays healthy above $100,000. Now, the shocking thing in this indication is that still only 3% of patients are treated with a biologic. That's also what you see illustrated here on this page. 3% of the patients are treated with a biologic. This is by no means a market where you have clearly established incumbents, that the game is already decided because you have some other big pharma companies in the market. No, this is a very nascent market where I think our objective and the objective of all other pharma companies, as well as the HS communities, is really to make sure that we treat these patients adequately. To elevate this 3% that you right now see in HS to numbers that are more similar to what you see in more mature inflammation markets like a psoriasis, like an atopic dermatitis, like an axSpA, like a psoriatic arthritis, where you see numbers of around 15%. Those are very much feasible and also required. Think again that HS is a disease where you have irreversible tissue damage, where you have scar formation, that even with the best drug, you are not able to remove these tunnels. You're not able to remove these scars. For that, you need surgery. We need to treat early on, and I think it's our objective and the objective of other companies to increase the treatment rate here with advanced therapies. On the right-hand side of this page, you also see that HS is, for various other reasons, a very attractive market for a biotech like us. First of all, the number of treatment options are very limited. It's not a market where you have 10, 15 available options, but right now you only have a couple of approved therapies. We looked at the data, and you see that they leave a lot of white space. I talked about the irreversible tissue damage, and that's also one of the reasons why this market is not as closely managed by the payers. You see lots of medical exceptions that are actually approved by the PBMs, by the payers. You also see that the treatments that are in the market actually have very limited efficacy and have partially some issues with tolerability or safety or durability. Lots of opportunity for a company like ours to actually get into the market and successfully commercialize this drug. Actually, it's a trend that you see overall. Even beyond HS, you see more and more biotechs actually launching drugs themselves and actually do it very successfully when comparing to analyst consensus. What do prescribers look for? Kristian already talked about it, and here is some of the market research that we have been conducting. When asking dermatologists what are the attributes that are most important when selecting an HS drug, no surprise, people look for efficacy and for safety. If you look at it a little bit more closely, you see that actually it's not one of the dimensions that truly stands out. It's a lot of factors that matter. On efficacy, it's not only a lesion count, it's the quality of life. It's the pain reduction. It's all these aspects that we talked about when we talked about the potential label for sonelokimab that truly matter for the prescribers. We even went one step further. We conducted a conjoint analysis with actually 250 prescribers, 250 dermatologists that actively treat HS, and we did not ask them, "What matters to you?" We actually presented them potential attributes of a drug. We presented some profiles of drugs that are currently approved and the profile of sonelokimab with some variations on the label, and try to understand now, which drugs would you choose given on differences that you see on the label? Do you get a claim for quality of life in the label? Does it make a difference whether you have a higher or lower HiSCR75, et cetera? I think most importantly, we see that the prescribers are very excited about the profile that sonelokimab brings to the table. We see a very high willingness to prescribe, and you see it in the bottom, also independently confirmed by research analysts from some of the banks that cover us. I think also very important and very interesting for us was to see the importance when it comes to the label and when you see the advantage that you can potentially get from having data on quality of life, data on pain, fewer safety warnings. Those are areas that actually make a very big difference when it comes to prescribing behavior in the market. Where do we stand with the preparation of the commercialization of sonelokimab in the U.S.? You see it here on this page. We have now incorporated the U.S. entity in the beginning of April. Our distribution operation set-up is well advanced with respect to state licensing, with respect to selection of a third-party logistics company, selection of specialty pharmacy set-up, serialization. We have produced the first commercial batches. We are starting to stockpile sonelokimab so that we have the supply that is needed for a very successful launch of this drug. We've done a lot of work on the strategic positioning, go-to-market model, pricing considerations. We've also further strengthened our collaboration network. We have very good partnerships with the leading KOLs in the field. We have a very strong partnership with the HS organizations that are very active in this market. We've also started the first discussions with payers and PBMs and are very excited about the traction that we have on that side. Very high excitement from their side about our product, also some opportunities for us as an innovative biotech, not only innovate in the way we generate data and show some very innovative drugs, but also thinking of new approaches, collaborations with payers, with PBMs to actually disrupt this market. Also worked on the brand identity. Lots of more work left for us, very clear. There's also a couple of key milestones ahead for this year. We're in the process of selecting or identifying the location for our U.S. headquarters. More to be announced soon. We're also in the process of appointing the U.S. leadership for MoonLake. The commercial team will obviously expand very heavily, including expansion of a field force, where we will actually plan to have a field on the ground as of the beginning of next year. We'll continue to work with the payers, with the PBMs to build partnerships there. Obviously, importantly, we will also work on continued manufacturing of sonelokimab to ensure that our supply is sufficient to meet the demand that we expect for this product. Last but not least, you see it on the bottom of the page, we have a very strong and healthy balance sheet. We have runway as is until the end of 2027, so covering the expected approval of sonelokimab. On top of that, we do have the collaboration with Hercules Capital, through which we have access to up to $400 million more in additional funding and additional non-dilutive funds. We're in a very strong position from a balance sheet, from a capital perspective, and actually very much looking forward to now preparing for what we believe will be a blockbuster launch. With that, handing over back to Jorge for some closing remarks. Thank you, Matthias. As we're coming here up on the hour, I want to make sure we round it off with some closing remarks, but also follow on my initial promise, to shed a little bit of light, in terms of what we expect for the IZAR-1 readout. Again, still keeping the focus in HS, I want to just take us back one step and look at what have we shown you when it comes to patients and prescribers. I really believe that we here have the potential to be the best-in-class drug, possibly the best-in-disease drug, in HS, as we're proposing what I would call a well-aligned label with the regulator in the United States, the FDA. Excellent position in terms of efficacy, real potential for a safety profile that really presents an alternative to patients. As Matthias mentioned, something that really sways the decision when it comes to prescription, and something that is very, very convenient, and therefore helps to get patients to treatment. As Kristian also mentioned, keeping that close relationship about discussing the disease, not about how you actually inject your drug. From a prescriber perspective, as a closing remark, clear indication for a leading label, supported by all the information that we've shared around our FDA interactions. If you actually see it from a payer perspective, as you started hearing from Matthias, obviously a very critical element in driving the commercial success of this product, because the market is so unstructured. Very important to talk about the value of those drugs for payers. I think the data that we've shown you, not only the label, which obviously payers will very carefully peruse in their decisions to support the drug when it's given to patients. As you see on the left side, that element that Kristian introduced when looking at the scorecards, because the payers will also do the scorecards of the drugs and compare. What is that percentage of patients that I get further in treatment, be it in efficacy, be it in patient-reported outcomes versus a competitor drug? Here, as you can see, I think we can have a conversation with payers where we say, for example, at a similar cost, our drugs just delivers two-digit advantages when it comes to patients that reach certain objectives. Also from a payer perspective, which as you know, will be a major focus of our commercial model, I think this data and this overall program of HS really delivers something that is very competitive. Starting to look forward and continuing to go along the timeline in 2026. Next stop, rheumatology. We start now moving into the readouts of our dermatology programs in phase III. Obviously, we read axSpA phase II earlier in the year. The first one is IZAR-1. I remind everybody that's our bio-naive study where we compare different doses of sonelokimab with placebo, our largest trial ever, and that we'll read in about a month's time. What should you expect from this readout? We prepared a summary so that you know what's coming. Very important, remind everybody that IZAR-1 is a trial with three arms that run the whole year, placebo, 60 mg SLK with induction, 60 mg SLK without induction. IZAR-2, another four arms, also running for a year. Obviously, as you read on the primary endpoint, we're able to share some information, but obviously we have to be careful not to unduly unblind the study and obviously follow the mark of the letter of the FDA on what can be disclosed or not. What will be disclosed is presented on the right side of the page. We believe that this is probably one of the broadest detailings of a primary endpoint in PSA. You should expect, within Q3, a press release. The press release will say what any other press release says in PSA. Did we meet the primary endpoint, or did we not meet the primary endpoint? As I said, we will go beyond that. We will be disclosing the absolute responses for sonelokimab in the main dose, which is the 60 mg with induction, as we all know from the ARGO phase II. We will be showing you the absolute responses for all endpoints, while of course stating whether we meet or did not meet. This will allow us to not only talk about meeting overall, but it will start giving you a sense of what kind of response can be achieved in a purely bio-naive population with sonelokimab. This will keep with the blinding approach that we agreed with the FDA, and will give you a very good sense of whether we're in line with ARGO and what's the effect in these patients. We believe that anything that aligns with ARGO will be a clear success for IZAR-1. Obviously, why are we so focused here on the absolute responses of sonelokimab? Because obviously in PSA, as you know, this is what matters much more for a prescriber here. The delta to placebo element is less important. We know investors will want to look for this information, but as we all know, there's no real placebos in PSA. Patients are treated with many different drugs throughout trials, in our trial and any other. We truly believe that the absolute responses and the breadth of data that we will present will provide a unique view on the primary endpoint on IZAR-1 and will allow many people to do comparisons already at this time point. We're very excited about it. Watch this space for a press release in the near future. Hopefully that was a very informative and robust session as we always do. A great story on HS. We're really excited as a company. Obviously more to come in other parts of our clinical programs. We will stop here, and open now for the Q&A session. We have a couple of questions here related to the VELA-TEEN study. One of the questions here from Rami Katkhuda, LifeSci Capital, "The adolescent HS data appear very strong despite the small sample size. How much of this benefit do you attribute to earlier stage disease, and do you expect the VELA-TEEN data on the label as well?" Maybe Kristian, you want to take this? Yeah, no, happy to take it. Rami, good point. I think what you suspect here is true. We treat these patients, these juvenile patients, at an earlier stage of their disease. They are probably less recalcitrant. They have seen less therapies. They are more in the inflammatory stage of their disease. I remind you that we allowed patients in the study that did not yet have a tunnel, which in my eyes is completely meaningful, because you don't want to wait until irreversible tissue destruction has occurred. We see a better response, but this better response is not an artifact. It is really driven by the fact that you catch, you start treating the disease at an earlier, more inflammatory stage of the disease. Since we all use anti-inflammatory drugs, it makes a lot of sense, and we talked a little bit about the potential to do some disease modification. That would be the goal. I shared with you that all these patients that we enrolled in the adolescent trial will have a chance to participate in the OLE. Hopefully, even from our own relatively small study, we'll get a first evidence if this is indeed possible. Rami, I remind you, this is more than just saying, "I model from some other juvenile indications, and therefore my drug can be used from 12 years on." This is actually generating data in patients from 12 years on. We want to get hopefully more in the label than just you can use the drug moderate to severe from 12 years on, but actually be able to talk about the pediatric population. There's section eight, use in specific populations. There is 8.4, which is your pediatric population, so in the label there is room to talk about it. Of course, we will try. These are exactly the areas we want to make sure that people understand. This is data coming from a real trial, successful trial in patients with adolescent HS. All right. We have a few questions here on the commercialization part. One of them here from Prakhar Agrawal from Cantor. "Why are access dynamics in HS different than in other I&I indications like psoriasis?" Maybe I take this one. I think first of all, in psoriasis, we have over 15 approved treatments right now. In HS, it's three. If you look at the outcomes, in psoriasis, you have quite a few good treatments that bring patients to a PASI 100 response, so full skin clearance. We are far away from these response levels in HS, arguably the unmet need is a lot higher in HS. If you look at the disease, you have to understand that in HS, you have a lot higher cost of care for the payers. Patients undergo surgeries, they visit the ERs, they take opioids, it's a very costly disease also for the payers. Also, you do have really some irreversible tissue damage here. In psoriasis or in atopic dermatitis, if you treat a patient, even if they've had many, many years the disease, you can get them to clear skin. In HS, the tunnels that have already formed, as per the point that Kristian just made about the VELA-TEEN data, once they have formed, you will not get them away without surgery. Same for the scarred tissue. You can treat the inflammation, you have irreversible tissue damage. That's also why it's, I would say, interesting and makes sense for payers to actually be more open for innovation in a disease like HS where you have costly care, where you have a true unmet need, and where you have irreversible tissue damage. The next question here on the commercial side, this one is from Thomas Smith from Leerink. "Can you comment on some of the pre-commercialization steps that you're taking in anticipation of potential approval?" I believe this one I've already covered earlier, also another question here: "How are you thinking about manufacturing capacity for sonelokimab and current drug supply?" Jorge, do you want to comment on this? Yeah, I'm happy to do that, Matthias. Thank you, Thomas, for the question. Perhaps I actually take the opportunity to underline a few of those elements on the pre-commercialization. Matthias was very clear on that list, Thomas, and I think that reflects how much work has been going on. Obviously, a lot of focus on the company regarding, of course, approval, valid data, et cetera, but we never stopped working on the commercialization setup. I would even describe the fact that I think we've already finished the first phase of pre-commercialization, as Matthias described, and now we're really moving to the next phase, hiring the team, and preparing all steps, including supply and I think very importantly, all the elements around access that Matthias already mentioned in the previous question, in answer to Prakhar's question. I think that's really the focus. Obviously, as you raised, Thomas, we need to make sure that we have drug supply in place. Here I would like to add that in terms of absolute capacity to supply the market, and that includes the U.S. and other regions, our current supply chain is ready to take us to year three or four of our market. Right? Some might ask, how is that possible in an earlier-stage biotech? I think here we were fortunate to inherit, if I may call it like that, already a very advanced supply chain when we licensed the drug from our partners at Merck. That allows us to be already ready to go all the way to those years into the market. Obviously, this is a tried and tested supply chain, Thomas. We've treated thousands of patients across both sides of the ocean, so we know it works. As we said, following the BLA approval and approval of our sites, we will be ready to go in terms of capacity likely to year three or four of market. That doesn't mean that we will stop developing our supply chain right now. We're also looking into other opportunities, namely second sourcing, et cetera, that will allow us to go into further years of the market, but also continuously manage the risk of supply chain. Thomas, I would describe it as a tried and tested supply chain, lots of capacity, FDA-inspected partners throughout. I think we're very ready, but we'll continue adding to our supply chain as part of our pre-commercialization steps. All right. Next, we have a couple of questions here on the safety side of things. One here from Phil Nadeau from TD Cowen. Can you discuss your confidence that you won't get a warning for suicidal ideation? Thought there was no signal in your trials. It is our understanding that the FDA often defaults to class labeling for rare adverse events. Have you discussed the SIB warning with the FDA? Similar questions were received from other analysts also related to the liver warning. Kristian? Yeah, happy to address this. Very clearly what we will end up having in our label remains a review issue with the FDA. They need to look at the totality of the data. If you look at the warning and precaution section in the IL-17A and IL-17F antibody, you see some things like be careful with TB. We will likely also get it, although the National Psoriasis Foundation has recently talked about this, there's no evidence that the MOA increases the risk of TB. We have all excluded patients with active IBD from our trials, that may lead to some words like use this with care in patients with IBD. There are other areas, and again, I use the example of the IL-17A and IL-17F safety, specifically the warning piece as an example, but there's a liver warning, there's a suicidality warning. What we can say is when we look at our data, we do not seem to have not only no signal, but we also don't seem to have the data that we speculate led to the warning in the label that I was just talking about. Our ingoing assumption is that there are areas to differentiate, and as we mentioned, the liver warning and the suicidality warning, and there will be areas where, Phil, I agree with your suggestion that we may be very similar. Next question here again on the label from Yun Zhong from Wedbush. Have you received confirmation from the FDA on whether VELA-2 data will be used for efficacy evaluation in addition to supporting SLK's safety? Jorge? Happy to take one of the label questions here. Yun, we have received confirmation from the FDA that we will use MIRA and VELA-1 as part of the establishment of substantive evidence for effectiveness associated with Section 14 of the label. VELA-2 will be considered beyond safety. There is a matter of review, whether it's more advantageous for us and prescribers to include VELA-2 in the table or only in the narratives. That will be discussed. When you ask what have we received confirmation for, that's the use of two adequate, well-established trials. That's MIRA and VELA-1. Another one here on the label or on the BLA submission. This one, again, is from Tom Smith from Leerink. First, on the BLA submission expected by the end of September, can you comment on some of the final gating factors or steps the company needs to take before delivering their submission package with respect to the regulatory path in HS and past discussions with the agency, understanding that you don't plan to meet with them again before submission. Can you talk about the importance of the Patient-Reported Outcome benefits you're seeing here in terms of demonstrating SEE in the eyes of the regulators? That's actually a few questions in here. First and foremost, yes, we're planning to submit the BLA at the end of September. I think the gatekeeping items here are finalizing the submission, clinical study report, finalizing the submission, also getting everything submission-ready on the VELA-TEEN side. Typically, big pharma companies, based on my experience, take six to nine months after completion of the parental trial. As you can see, we are presenting the data today fresh off the press, and in about three months' time, we plan to submit the BLA, so we are already trying to do this a lot faster. Now, do we cut some corners here? No, absolutely not. We've already been preparing very well for the submission. After the readout in September, we already had a 16 weeks data, and all the documents were already drafted, now need to be finalized for the submission at the end of September. It's also correct that we will not meet with the FDA again on the HS side. The pre-BLA meetings that we've had at the beginning of April, at the beginning of May, on the clinical side and on the CMC side, were the last interactions that we've had with the FDA before the submission. Everything was very clear in these meetings. We received very clear guidance, so now it's up to us to execute and submit the filing in the end of September. Finally, your question on the Patient-Reported Outcome benefits. Yes, very important. We've had explicit discussions with the FDA already last year about if you want to have claims on quality of life, what are the instruments that you should use. Reminding you again that we are the only company that actually has the HiSCR, the HS-specific quality-of-life instrument in the hierarchy as a key secondary endpoint. Therefore, we are also aiming to get a label claim on quality of life into the label. We think that will be a very important differentiator versus other therapies. Whether or not that is a crucial part in demonstrating substantial evidence for effectiveness, I think here, as Jorge said, as Kristian said, the FDA looks at everything, certainly doesn't harm, but I doubt that at this point, people really have serious doubts that this drug is not efficacious. Certainly will be considered. We're planning to get it onto the label, and we think it will be a very important differentiator. Now, another one. Here again on the label, I think we covered it, but one now moving to IZAR. This one is from Kaveri Pohlman from Clear Street. To what extent do the results presented today increase confidence in the upcoming psoriatic arthritis readout? Kristian. Happy to take this. If you take a step back and you just ask yourself in how many indications have you now seen promising clinical data, but also mechanistic data with your IL-17A and IL-17F inhibiting Nanobody sonelokimab, there's great data in psoriasis. There is great data in palmoplantar pustulosis, second dermatology indication. We are about to read out in psoriatic arthritis. We have shared with you data in Axial Spondyloarthritis. I think of course, the great data in HS. Does it increase the confidence that you go to various, what I would call type 3 diseases, so diseases where we know that the IL-17 pathway is probably center stage. Does it increase the confidence that if you go from indication to indication type treatment, you see great responses to your drug? Absolutely yes. Ultimately, the data will hopefully confirm this. I want to also share with you or remind you that we do studies with imaging in both PSA and in axSpA. This imaging is intended to generate more evidence on the question, do you get any advantage from your molecule? Is rheumatology another disease area where you potentially benefit from your drug being small, albumin binding, probably reaching at the enthesis, for example, better than other drugs. It's also taking these imaging results into consideration. We already shared with you the PET imaging and the MRI imaging in axSpA. As I said, we will get more innovative imaging, PET imaging in psoriatic arthritis. If I look at the totality, the clinical data, this imaging data, the biomarker data, didn't even talk about this, in the peripheral blood, in the tissue, yes, our confidence is very high. Of course, ultimately, the clinical data has to show this. IZAR-1 is the largest phase III we have conducted so far. It's 1,000 patients. As you know, this is the bio-naive patient population in PSA. In addition to the classical readouts, we will look into radiographic progression, some more complicated endpoints. We are sitting on the edge of our chair, as you will do. I think the confidence level is very high. Perfect. We have another question here from Ram Selvaraju from H.C. Wainwright. How has the reaction from strategics and collaborators been to the 52-week VELA data? In particular, has the longer-term evidence supporting sonelokimab in HS led to any notable change in the way SLK is perceived in this indication, particularly versus bimekizumab? Jorge? No, happy to take that. Ram, thank you. Thank you for the question. I think even the way you framed the question is absolutely spot on. I think if we reflect on how all the KOLs and some of the biggest prescribers in the U.S. have been looking at this data as it was presented at 40 weeks, obviously at AAD, but also for those that are familiar with the data that was presented to you today, I think it continues to really mount in terms of the excitement around SLK. Sometimes we even have heard from investors that they were almost surprised by how positive the future prescribers of the drugs are versus their own perceptions. I think this excitement around the community, be it KOLs, be it large prescribers, be it folk in the U.S., be it folk in Europe, be it patients, foundations, associations, I think that excitement is really growing. I think the reasons for that are hopefully were laid out clearly today for everybody, which is this concept that Kristian mentioned around the scorecard. That's what patients, that's what physicians will do. I think that long-term evidence, which is what really matters in dealing with the disease, obviously, physicians are far more interested in what happens at one-year mark, at two-year marks, et cetera, rather than at what happens at three months or four months, because obviously this is a chronic disease that needs to be managed over time. I think this evidence just continues to drive that change. I think that also when you add to this, the fact that the drug seems to have a benefit ratio that is perhaps a little bit easier to manage, probably a lower barrier of acceptance when it comes to how easy it is or how much easier it is in our view to be administered and to dose, the fact that this is a drug that has very high likelihood of having a label for the very first time approved for 12 years on based on the data. I think the reaction has been extremely positive. Matthias also mentioned it. Several investment banks out there have made their analysis. People assuming that our market penetration will be around 20%-30%. Matthias mentioned to all of you all the work that we have done in terms of conjoint analysis, et cetera, to really detect with a basic label for us what would that mean, and we end up basically in the same place, about a quarter of the market. As Matthias mentioned, the upside opportunity there is if various little things that we discussed today around the label actually come to be, some of which Kristian has just described in some of the answers to the questions. I think we're starting from a high-potential position in terms of market share, obviously a market with very few competitors, lots of opportunity. Also, I think, Ram, a true opportunity now more than ever to really become perhaps the best-in-class and best-in-disease drug in HS. Thank you, Jorge. I'm afraid we're at the end of the allocated time before markets open. Thank you all for joining. We hope that you enjoyed this webcast and the presentation of the new data. As always, you will find the presentation document available on our IR website, and a replay of this webcast will also be made available today. Once again, thank you for joining. Have a good day.
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