UCB SA (UCB) Earnings Call Transcript & Summary

Hello, everyone, and welcome to UCB's EADV Capital Markets Call for Institutional Investors and Analysts. My name is Yvonne Naughton, and I lead the Investor Relations team here at UCB. Today's presentation is available for download on the Investor Relations section of our website. The presentation and Q&A session are subject to the disclaimer and safe harbor statement contained on Slide 2 of the presentation. On today's call, we will be discussing key takeaways from data being presented at the EADV Congress in Vienna, which supports the long-term impact of BIMZELX on tunnels and potential to prevent disease progression in hidradenitis suppurativa. Hosting our call today is UCB's Executive Vice President and Head of Patient Evidence, Emmanuel Caeymaex. And we're delighted to be joined by Dr. [ Amit Garg ], Professor and Founding Chair for the Department of Dermatology, Northwell Health, New York. Following the presentations, we will open the line for questions. As usual, we will try to address as many questions as we can. So please limit your questions to allow to part in the Q&A. And with that, I'll turn the call over to you, Emmanuel.

Thank you very much, Yvonne, and welcome, everyone. Dr. [ Garg ] and myself are here in [ sunny ] Vienna. It's incredible to see how EADV has grown as a meeting. I think we're talking about 20,000 participants. So dermatology is certainly the place where science is translating very fast. And of course, for BIMZELX and for us, we are now in a post-launch phase and a lot of evidence becomes available from our open-label extension studies as well as from real-world experience. And this really reinforces our confidence as well as the confidence of prescribers as we know has multiyear follow-up data. So on the next slide, you'll see a quick recap of where we stand. So truly, BIMZELX now is available globally. We recently had approvals in China for psoriasis and [indiscernible] and are working on broad access there. Interesting, we have more than 250,000 patient years of exposure. So there is definitely a body of data now and a reassurance that comes with the safety profile where no new signals have been identified. And if anything, with continued use of the product, we see that it is indeed very well tolerated. Now in terms of the share of BIMZELX in the various indications we have, psoriasis is continuing to do very well. It's a very competitive market. Within the 17 segment, BIMZELX stands at about 35%, which is more or less the dynamic share we hold in the U.S. and in the rest of the world, some markets are above that and some slightly below. In [ HS ], we're getting closer to the 50%. I'll come back to that later. But clearly, within the 17, we are now within striking distance of taking the lead. And you see on the bottom left panel that when you reset the various interleukin launches to time 0, that BIMZELX has accumulated the more patients in the first 33 months post launch. And there's a few inflection points here. One really came with the expansion of access around month 15 there and also the psoriatic arthritis and [ AXA ] approval. The second one came with the HS approval, and we've seen worldwide a very rapid adoption of the [ ALt-1 ] in products and BIMZELX in particular. And then lately, we've seen our continued investments and broadening of the access both geographically and in the U.S., and you see that steep curve there towards the last few months, which is very much continuing as we speak. Now the market itself is growing healthily in psoriatic disease, it's at above 5% per year. And you can see that for BIMZELX, of course, those rates are much higher, partially owing to the fact that it's a more recent launch, but partially also with the new data releases and the proofs of superior clinical effectiveness that we have generated with patients and investigators. In hidradenitis, obviously, BIMZELX is still a relatively newly launched drug, but it's also a market that is expanding. And so you see the market itself growing at about 20% in the U.S. for the last 12 months and BIMZELX, of course, clearly out doing that. Next. I'm sure you're all very familiar with the fact that with BIMZELX, we've generated 4 straight superiority studies. Those were randomized controlled studies utilizing ambitious endpoints that really contributed to lift the bar in psoriatic disease and specifically also in psoriatic arthritis recently with essentially the first study that demonstrated superiority between 2 agents using a straight ACR score and in this case, [ ACR50 ], which really is a clinically meaningful one. Now we've seen also that the effect and the difference is very high as of week 4. So it's a benefit that patients can feel or many patients can feel very early in treatment. And that, of course, then promotes adherence and continued use of the product in a disease that is multifactorial, difficult to treat. We were also pleased to read out this study, which wasn't small, right? We were -- we had more than 500 patients randomized across risankizumab and bimekizumab and except for a higher incidence of oral Candida, there really wasn't any difference in totality, really no differences in patients leaving the study for safety or tolerability reasons. So both well-tolerated agents in this particular study. And we are pleased with the lead indicators that we're seeing in terms of how this is starting to change behaviors and also stated behaviors, but also real behaviors, both in the rheumatology space and also in the dermatology space. Next. Right. So recently, we revised our sales guidance to exceed EUR 7 billion. Now part of this is related to the execution with excellence. And of course, like other players, UCB is leveraging artificial intelligence to make sure that where we use the predictive power of AI in our targeting and engagement strategies, both with health care professionals, but also with patients, in particular, in the United States, really an important engine to make our DTC efforts more efficient and effective. And second is also the continued expansion of our access, as I mentioned earlier, geographically beyond the U.S., but also importantly, in the United States where we have more PBMs now covering BIMZELX or first line in several indications, if not all. And this has been a disciplined expansion to make sure that we wouldn't give away too much value considering the superiority of the clinical profile that's been demonstrated with the studies I mentioned earlier, but also with our long-term data, which really are very encouraging. We even have a cohort with psoriasis patients in North America that generated 5 years' worth of data where we're seeing that north of 85% of patients on a modified NRI basis actually have a [ DLT ] of 0 or 1, which is really what is being aimed for. So that is really impressive and hasn't been shown before. We see similarly good data in psoriatic arthritis and [ HS MPS], some of which are presented here at the scientific meeting. Now that isn't the end, of course, of our label expansion with BIMZELX. The pediatric studies are moving forward very nicely. A special shout out to the HS pediatric program, which goes down to the age of 9. And that is important because some of those children turning -- almost turning into adolescents, unfortunately, are starting to show symptoms very early. We have the psoriasis study that will read out in the first half of next year in pediatrics. And then, of course, our goal is to lead in the 17 pathway and palm [ panperculosis ] really is a 17-driven disease with an important role for the [ IL-17F ] cytokine, which was documented in a small series a few years ago and where the Phase III now is fully recruiting and has been started about 3 quarters ago. So more to come with BIMZELX, obviously, as we continue to understand the impact that this medicine can have across a range of conditions beyond psoriatic disease, HS and [indiscernible]. Next. Now obviously, today's call is very much about hidradenitis suppurativa. You can see that our dynamic share has continued to expand in the United States, and this is with biosimilar [ adalimumab ] as well as Humira and [ secukinumab ]. So BIMZELX holds a bit more than 1/3 of the new and switch patients right now, and that is continuing to expand. And in fact, you can see at the bottom on the left-hand side here that in the most recent intention to prescribe survey with health care professionals, 84% of health care professionals were very likely to prescribe BIMZELX in the next 3 months. So that's increased. And we see like the mirror image with [ ukinumab ]. So I think that the product really is taking hold. And obviously, the experience, the data, but also the access improvements make it more and more straightforward to utilize BIMZELX in the U.S. What's noteworthy about the U.S. market is that about 70% of the usage of biologics is [indiscernible]. It's a little lower in Europe. And I would say that by now, outside of the U.S., the BIMZELX holds at least 50% of dynamic share if one was to calculate the weighted average across all of those markets. So we are in the process of crossing that 50% 17 dynamic share as we speak. And then many of you have had questions around the growth rate of the HS market. In the U.S., it's actually been pretty busy in dermatology clinics with HS patients. And we see that patients treated with biologics have increased by 20% over last year, which is rapid growth. In other markets, we're more kind of in the mid-teens, depending really as to when BIMZELX launched. That's, of course, a huge factor. We also know that at this conference, we have some data on new products. And of course, UCB's research is also working based on our scientific understanding of the disease to make sure that we continue to bring new solutions to patients, many of which are not yet fully satisfied with the products that are on the market. This being said, I think the data that are being presented here really indicates the impact beyond the high score measure that a drug like BIMZELX can have. And it's now well understood that treating earlier leads to better results. That is the case in many autoimmune diseases. So not really surprising, but we now have sufficient long-term data in sufficiently precise ways to be able to ascertain that. And Dr. [ Garg ] will describe some of the new evidence there. There really is this potential by treating early and hard to alter the disease trajectory, which really in HS is important given the damage to the epithelium, but also to the patients well being, some of which is irreversible. And finally, we are seeing through 3 years outcomes now that this is not just, again, about those high scores, but the quality of life, skin pain, itch, et cetera, et cetera, all these measures are improving in patients that we've been following for a long time. And so it's really exciting to see that this wasn't just 16 weeks or 52 weeks phenomenon. It's something that even tends to improve in this difficult-to-treat disease. And so with all of this, I think it's time for us to start looking at the data, the evidence and the commentary from Dr. [ Garg ].

Okay. Thank you, Emmanuel. My name is [ Amit Garg ]. I chair our Department of Dermatology at Northwell Health in New York, where we've got a large academic health center practice of over 50 dermatologists, and we focus almost primarily on inflammatory skin disease. And within that, we have a large referral center for the region in HS. So we have a lot of deep experience in this disease, both prior to the advent of targeted treatments and now with them, and it's been really amazing to see the sort of trajectory of treatment and really where we can bring our patients with treatment over that time. me have the next slide. So yes, I work with several companies. Most of my work is really in supporting the design of clinical trials to help bring more and better therapies to HS patients. And I've worked very closely with UCB for years on their drug development program. I think most likely, all of you on this call would be familiar with what is depicted here as images. But let me introduce you to a very specific aspect of what I'm showing you in this disease, and that is the tunnel. The tunnel is a very unique kind of skin lesion. It's a hollow structure that bores deep into the skin. And that structure becomes inflamed. So that inflammation really resides deep in the skin and accumulates byproduct of inflammation, fluid, which when it opens to the surface of the skin can drain. And drains are really unique and malodorous fluid and it's quite painful just because of the degree of inflammation that lives within the tunnel. If we are lucky enough to get a tunnel to resolve over time, it doesn't just go away. It leaves behind a very impressive stigmata of its disease, which we call a rope-like scar, and you're kind of seeing that in the third panel there. That rope-like scar also results in some discomfort and pain, but very importantly, limits or restricts mobility and movement. So when you can imagine that this lesion exists under the arm in some significant degree, patients are actually unable to even move their arms past midway. So it significantly limits one function. Suffice it to say, the tunnel is probably -- is certainly the most impactful lesion in HS. It's probably one of the more, if not the most impactful lesions in all of dermatology. And so I really wanted to kind of sort of emphasize the meaning of a tunnel to an HS patient as I then tell you about some very important clinical data related to treatment of tunnels. So this is a slide just to kind of describe in all of the ways this disease and within that tunneling within this disease can impact the life of an HS patient. Everything from daily functioning just to being able to have a comfortable night sleep, getting to work, going to work, going to school, keeping a job, sexual function and how all of that can affect on mood and life otherwise. We'll go to the next slide. Before I jump into some very remarkable clinical data, as a clinician and as a scientist, it's very important to me that clinical data is premised on some kind of translational or biological sort of evidence, right? The treatment of a condition has to make sense for what we expect it to do. And I think that's certainly the case here with bimekizumab, which, as you know, is an IL-17 inhibitor, but specifically or it inhibits both IL-17A and F. And when we look at lesional skin of HS patients on the left panel, you see a routine biopsy of lesional skin and HS. That skin is flooded with IL-17 and not just IL-17A, but also IL-17F. It is highly expressed in lesional skin. And more specifically, when we look at the expression of both IL-17A and F in particular lesion types. So we see here the nodule, which is probably the most common inflammatory lesion in HS in terms of frequency and then also tunnels, as I said, the most impactful, both IL-17A and F are overexpressed in both lesions. So suffice it to say, there is good translational and biological premise for being able to block both IL-17A and IL-17F and have a meaningful impact on inflammation in the skin and HS. So let me tell you about the 4 abstracts I'll try to give an overview of. Essentially, what we're going to be looking at is response on tunnels, draining tunnels, but also we'll tell you about nondraining tunnels. We'll look at it in a couple of different ways and how it impacts life quality. And it's important to point out that this is long-term data. This is data that exists over 1 to 3 years. So you get an appreciation for how the drug can have an effect on tunneling at a year and then more durably and longitudinally across 3 years. Let's start with the first abstract. So in this abstract, what I'll describe to you is [ IHS-4 ] responses at years 1, 2 and 3, and we'll also talk about proportions of patients achieving categories of draining tunnels at baseline out to over 3 years. And we're going to -- there are a couple of important sort of aspects of this data, which I want to point out. The first is the outcome that we're looking at is IHS-4, but it's also a higher threshold, the highest threshold of IHS-4 100. That means that there is total control of inflammatory lesion count, 0 inflamed nodules, 0 abscesses, 0 draining tunnels. That is the ultimate state that we want to get an HS patient to, okay? And we're also going to do is look at the data stratified by duration, low disease duration around 2 years and high disease duration around 10 years. And what we see is that bimekizumab has really an incredible response on this very high threshold of total inflammatory count at year 1, and it improves overall out to year 3. The longer you stay on the drug, the better you do. What we also see is that when we stratify by disease duration, patients with a lower disease duration have even a better chance of achieving that really complete remission essentially of inflammatory lesions than do patients with higher disease duration. Now what that means is it's going to be up to the clinical community to be able to identify these patients earlier. That's been a problem historically, but we're making a lot of progress there to identify patients earlier. But when we do find them earlier, we have to get them on the best treatments that give them the optimal chance of achieving a good outcome. And clearly, this data would suggest that using bimekizumab early on in the course of disease is very important and is more likely to give them the most desirable outcome of that [ IHS4-100 ]. What we're seeing here is bimekizumab's effect on essentially a category of draining tunnel count. And obviously, the category we want to achieve is the one that's shaded in dark green, 0 draining tunnels. And what we see is that at year 1, there's a substantial proportion of patients achieving that category of 0 draining tunnels. And what we see, again, is over time is there's a higher proportion of patients achieving 0 draining tunnels overall on bimekizumab. And not surprising, similar to the last slide, what we see here is an improved or augmented response on draining tunnels when we find and treat patients earlier with bimekizumab. So a higher proportion of patients will get to that 0 draining tunnel count when we find these patients early and treat them with. In this next abstract, we're going to look at, again, draining tunnel counts, the mean decrease over 3 years. We'll look at, again, counts of patients achieving drain tunnel counts of 0 and right, and longitudinally sort of over 3 years. Let me kind of get to the next slide to kind of give a little more context. Now in looking at those similar outcomes in this slide, we're looking at stratifications by bio-experienced patients, HS patients and bio-naive patients. What we see in this slide is that all bimekizumab patients, regardless of their prior experience with biologics, experienced a really substantial decrease in draining tunnel count through 16 weeks and all the way out to year 3. You can see that the counts go from as high as 7 down to a mean count of as low as 1.1 around 1, okay? That's a really substantial increase for an HS patient. But what we're also seeing here is even when bio-experienced patients achieve a very similar response as overall bime patients, that response is even greater in bio-naive patients. And that's not surprising, but really what it does suggest is we should be using bimekizumab as early as we can, as I pointed out in the other abstract, but even as a first-line agent because that's what's most likely to give the optimal response on draining tunnels here. And again, this is looking at categories of patients achieving a draining tunnel count of 0 compared to baseline at year 1 and year 3. And what we see is overall a very robust response on draining tunnels at year 1 that continues to improve out to year 3. So the longer you stay on therapy, the more and more sort of a response you have on draining tunnels. But what we also see here is that, again, bio-naive patients are going to have an even more augmented response and more likely or a greater proportion will achieve that really high bar of a draining tunnel count of 0. So, so far, the data really does indicate when we identify patients early, we start early. Ideally, we started first, and we keep it on board out to a year and through 3 years, we're going to see a robust response and continued improvement in response over time. Next slide. I was happy to be part of this study where we looked at a very important concept and one that may be new that you may not have even heard about for other molecules or certainly even related to this disease state, which is the total tunnel count. We've been talking up until now about the draining tunnel count, but I'm going to describe data here related to the total tunnel count. Go to the next slide. Now before I describe the data, let me talk a little bit more about what this means to a clinician and ultimately, what I think it means to a patient. We've already discussed how draining tunnels are so quite impactful for HS patient in many ways. When we talk about total tunnel counts, we're including draining tunnels, but we're also including the nondraining tunnels, which can flip back and forth between nondraining and draining. But by reducing the total tunnel count with bimekizumab, what it suggests is that this drug is having a biological effect on a physical structure that allows it to resolve. This is a totally new concept in HS. I think this is the first time where I've seen data that allows me as a clinician to appreciate that medical therapy can resolve tunnel structures. We, to this point, we used to believe that was only possible with surgery. And these surgeries are not trivial. They are skin surgeries, but they are major surgeries that involve removal of regions of skin that we then leave open and take the wounds typically take somewhere around 4 months to completely close. So you can imagine someone's entire axilla on both sides removed and left open for 4 months. So it is a major surgery. But we thought that, that was the only option. And now we're seeing clinical evidence, trial evidence, long-term evidence that we can actually resolve tunnel structures with medical therapy. So what we're seeing here is -- and really the main -- we've talked about draining tunnels, but the main focus should be on the left panel here, where we're looking at achievement of a total tunnel count of 0, resolution of tunnels. And what we're seeing is that through 16 weeks, the percent of patients achieving a total tunnel count of 0 is slowly increasing, and that increase continues out to week 48, where almost 1/3 of patients on bimekizumab by week 48 achieved a total tunnel count of 0. Now to achieve that, you also have to have a response on draining tunnel count, which is a subset of the total tunnel count. And you see a very similar response on draining tunnels that would support what you see for total tunnels. Next slide. Okay. This is also looking at, again, reductions in both total and draining tunnel count. And this is the mean decrease in total tunnel count over time. So what you see is that any bime exposure through 16 weeks is resulting in a mean decrease in total tunnel count. When placebo patients switch over, cross over, they achieve a very similar effect on resolution of total tunnels. And I'm probably being repetitive, but it really -- for me as a clinician and working in the space with patients over the past couple of decades, this is really novel information that changes the way we think about medical therapy. And again, you see a similar response on draining tunnels, where you see a decrease in draining tunnel count over time with bime exposure over 16 weeks. That response continues to improve through week 48. When the placebo patients cross over, they achieve a close and similar result to the previously exposed patients with bime. Okay. Well, I told you about how impactful this lesion is. We've described the data for bimekizumab on the long-term sort of impact on draining tunnels. We've described bimekizumab impact on total tunnel count over the long term. If all of this is happening, it should -- it must translate to some improvement in quality of life, and that's what this abstract also demonstrates. And we look at quality of life for HS now in a couple of ways. One is with DLQI, which is a general skin disease quality of life measure. And what we're seeing here is that the total DLQI score mean is decreasing from above 10, so around 11 down to 4.5 across bimekizumab exposed patients. And that number, those step change is really significant. Going from 11 to 4.5 represents a really dramatic improvement in life impact. Essentially, when you get to 4.5, you have minimal impact on quality of life. That, too, is a very -- I don't know, to me as a clinician, just a remarkable concept to just think about that I can -- with medical treatment, go from high worse impact down to minimal impact on life for this disease. The other way that we look at life impact is through a measure called [ High Swell ]. [ High Swell ] is the first disease-specific quality of life instrument developed for really this disease, HS. And that is because we appreciate the many unique symptoms and features that HS has for a patient with skin disease. There are many aspects of HS, which DLQI doesn't just can't capture. And therefore, there is the need then to have an instrument that is unique to -- specific to the symptom burden in HS to really try to understand how quality of life improves for those patients. And we're using a disease-specific instrument here, but essentially, we're seeing a very similar theme. We're looking at bime-exposed patients and the proportion of patients achieving a total high score of less than 14 from where they were from baseline and less than 14 is a very important number because that gets patients to a very -- a clinically meaningful difference on life impact where they have no to mild impact from their disease. And you can see here 3 out of 4 patients on bimekizumab out to 3 years report minimal to no impact of their disease. And it's not a coincidence. It is also directly related, in my opinion, to bimekizumab's impact on that tunnel lesion that we started talking about. So just to summarize then, really then we've talked about the importance of the tunnel, the impact of the tunnel, how bimekizumab affects the draining tunnel as well as the nondraining tunnel and the total tunnel count, so resolution of tunnels. We've talked about how treating patients earlier in their course of disease gives them the best chance of that high bar outcome on bimekizumab. We've talked about how using bimekizumab first line also gives patients that better outcome with that high bar. And then we've discussed how these results happen really out to 1 year and really out to 3 years, or a durable impact of the drug and how all of that translates to life improvement for our patients. Thank you, and happy to sort of engage the discussion.

Thank you so much, Amit. Really, really nice data, and thanks, Emmanuel as well. So now we're going to hand over to the operator to start the -- or to give instructions on how to do the Q&A.

[Operator Instructions] Your first question comes from Stacy Ku from TD Cowen.

Wonderful presentation from you both. I have a few questions for Dr. [ Garg ]. Maybe as we think about the size of the HS market and clearly, we're in the beginning of a nascent potential market growth, there's a lot of questions as to kind of what the clinicians are seeing in the real world. So maybe talk about what the academic community is sharing in terms of how they are diagnosing and treating patients, maybe potentially earlier. What are you seeing in your practice in terms of patient volume, expectations moving forward? What are the kind of limiting steps when it comes to these treatment of patients? For all of us, we're just looking at the prescriptions, but just trying to understand what's happening behind the scenes there. So that's the first question. And then the second question, Dr. [ Garg ] is also for you as well. UCB has always been very transparent that obviously, while BIMZELX has best-in-class efficacy so far, there are also patients not well served. So just help us understand as we think about your positioning and usage BIMZELX all your commentary from today, how we might compare and contrast that to potential positioning, your thoughts on other entrants. We get the most questions on drugs like [ remibrutinib, lutekizumab ] and most recently, [ tosokibart ]. I'm not saying very well. But thank you so much.

Sure. There's a lot in there. So there's a few things to think about. Let me start with the first question, which is who are these HS patients and where are they? I can tell you my clinics are full and many clinics are full. But let me try to sort of address this in the context in which I think you're asking about it. When we first started looking at prevalence of this disease a decade ago and actually have published the first population-based paper in the United States related to this issue, we published a prevalence of 0.1. But that prevalence was based on diagnosed cases. We know very well for this condition that there may be the majority of patients who remain undiagnosed at that time. Now since that time, we've tried to look at prevalence, not just from the perspective of diagnosed cases, but even symptoms, right? If these patients don't have a diagnosis, they're having symptoms and can we capture probable cases of HS by including those symptoms or even procedures related to the types of lesions that HS has. And when we look at the data that way, the percent -- the prevalence is actually closer to 1%. It's probably around 0.7% in the United States. Now there's a worldwide effort to try to understand prevalence and that prevalent by using a very rigorous standardized methodology. And the average or the mean prevalence is probably around 1% worldwide, some countries having more, some countries having less. So we think that the prevalence estimate is higher than probably what we initially thought 10 years ago. I also think that what I'm seeing in my practice, what I'm hearing from my colleagues, what we're discussing in patient advocacy groups is that the awareness of the disease is also significantly increasing, both in the medical community, but also very importantly, in the public and patient community. I can't go a week without my teenage daughter showing me a TikTok on HS. I'm now seeing commercials, obviously, branded on HS. But this has the effect of creating awareness in both sectors, but it also allows patients to ask themselves who have symptoms and undiagnosed, could I have HS, and they're bringing it to the attention of their doctors, their surgeons, their primary care doctors, whoever they're seeing, they're even bringing it to the attention of us. I sometimes get patients who walk in and say, I think I have HS. So I think if we think about it in terms of our market share, I think it's growing. I think we're getting -- our prevalence estimates are higher than what we thought. And I think because of the awareness in the medical and public sectors, patients who are undiagnosed are finding ways to diagnose this more frequently. The other issue related is once you diagnose a patient, then the question becomes when do you get them on a targeted treatment. And given the high symptom burden of this disease, given what we know its natural course to be, which is progressive, debilitating and progressive for most HS patients, our interest as clinicians is to get them on treatment as early as we can within what sort of the label would suggest and what the regulatory environment requires us, moderate to severe disease. The medical community is doing some work on defining what moderate to severe disease is for clinical practice. And it's not the same as what it is nor should it be the same as what it is in clinical trials. The HS Foundation and historic will publish a paper probably in the next month or 2, which defines moderate disease for clinical practice. And the bar is not -- the bar is going to be low, okay? Because we know that these patients, we know what their ultimate course is. We have to get them at a time when treatment will actually make a meaningful impact for patients and the bime data would support that. When you treat patients, when you find them earlier and treat them earlier, the outcomes are better. That's what we see in practice, and that's what the bime long-term data would support. So in terms of that type of engagement, I think the prevalence is higher. I think we're diagnosing patients more frequently. I think we're seeing patients come earlier and the medical community is trying to get to treatment targeted treatment much earlier than what we historically have been thinking is necessary. That was maybe a long-winded answer to your first question. But -- and the second question is a little bit around how does bime maybe kind of stack up in the marketplace, especially in the context of a robust pipeline. So what I would say is you mentioned there are some patients who don't respond to bime. That's true. That's true of the disease state. I haven't met a patient that is a super respond -- I mean, there are very few patients who are super responders, but you can't predict which drug they're going to super respond to. But most there are many patients who don't respond to a targeted treatment in any class. That's just the nature of the disease. It's not specific to bime or even the class IL-17. Why I think bime has had such an uptake in the community and the marketplace is not so much because when you look at [ HiSCR ] responses, [ HISCR ] [indiscernible] differentiate. These MOAs do, but the [ HiSCR ] endpoint doesn't really allow us to meaningfully differentiate. The differentiation comes in a lot of the sub-analyses, the details like the ones I just presented, where we get an appreciation of how drugs differentiate from one another. And for me, given the impact of the tunnel and given bime's effect on the tunnel and that continued effect, not just at 1 year, but continued improvement out to 3 years and probably longer, gives me the impression that bime has a real meaningful impact on the most symptomatic lesion and does so with potency and depth of response and does it durably. Those are the things that influence my prescriptions at the bedside because the endpoint of [ HiSCR ] itself doesn't, right? So it's the other information that helps you have a conversation with the patient, how is this disease affecting you? Most always they say the tunnels and the drainage. And then we think -- and then we talk about the data that supports where they want to get to and this to the top for me. And I think the market data would sort of demonstrate that, that a lot of my colleagues probably feel the same way based on the data. How will it do in the -- compared to the pipeline? So yes, [indiscernible] -- there's some enthusiasm for [ REMI ]. It's an oral medication. It's already on the marketplace. It seems like a safe drug. But my question on [ REMI ] is I need to see the data. They went from a platform -- essentially a platform study right to a Phase III. And this is a disease state where it's, I don't know, somewhat of a -- it can be a crapshoot. And so for me, I'm going to really want to see can they regulatory hurdle based on efficacy, and I'm sure they will on safety. But then what is going to be that depth of response? What is the -- they may not differentiate on [ HiSCR ]. Chances are they won't because it's the High score. But what about that sub-analysis data? How do they really do on tunnels? What is the long-term data look like? Do patients continue to improve? I think those are the questions that we're going to need to see as it relates to the pipeline. So just regulatory approval based on 16-week data may not move me towards another drug, even if it meets that regulatory hurdle. The fact that bime has long-term data and data around the types of lesions that impact my patients the most, just having another option may not change what I do with bime. I'm going to need to see that long-term data like bime has 1-year, 2-year, 3-year data for me to feel compelled enough to say, no, there's another or a better drug for you. But I think that's years away.

[Operator Instructions] Our next question comes from [ Hen Burd ] from Deutsche Bank.

I've got one on, I guess, fitting into the different mechanisms and maybe why you think an IL-17 would outperform the emerging mechanisms like an IL1, TL1A, BTK on the draining tunnel closure specifically. And I'm thinking here because TL1A linked to fibrosis might mean the inhibition would be better suited to addressing the tunnel disease.

Yes. It's a very good -- first of all, I should just say that I've done a couple of these calls, and I'm always impressed by the degree of knowledge and the sophistication of the questions you asked. I don't even get this in an audience full of dermatologists, that degree of sophistication in your question. So I just want to say that because I appreciate that. What you're describing makes sense in theory. That's as simple as I can say it. These medications, these pipeline drugs have good translational premise, right? That's the reason why you would pursue a drug development program around it. They have to start with having a good translational premise and good conceptual premise. And the concept of inhibition of fibrosis is very relevant to a condition like HS. Maybe I believe it a little bit more because really because on the heels of what bime has shown that medication can have an effect on tunneling. But I would -- again, you really kind of need to see the data and not just see it at 16 weeks, but really see it at 1 year, 3 year, even longer. We'd love to see this in the real world in post-marketing registries. So -- and that's years away. So while there is a robust pipeline, we're really sort of patient centered in the way that we're going to approach treating this disease, it has to be based on the long-term data that we have, not even based on a couple of hundred or even 1,000 trial patients at 16 weeks. So I'm excited about it. There's enthusiasm for it conceptually and translationally, there's premise for it. But I think we're years away from really understanding whether it truly can deliver on what the concept and the translational premise is.

Our next question is from Xian Deng from UBS.

So I have one question for Dr. Garg, please. So this is actually kind of a follow-up question on Stacy's first question on market size. So especially kind of thinking about some of the data you actually showed where patients with longer disease duration actually have worse or less response than some of the, let's say, maybe the earlier stage patients. So just wondering in terms of the traffic of patients versus, let's say, this time last year, have you actually seen, let's say, maybe a decrease in traffic? Because I would imagine this time last year, we just got BIMZELX, we just got [indiscernible], you presumably have a lot of patients, bolus of patients have nothing. So just wondering, all that's kind of not the case at all. So just wondering what have you seen in terms of real world in terms of the dynamics versus let's say, the bolus of patients versus the patients, let's say, seeking treatment?

Yes. Let me just make one clarifying point. I think we're talking about the same thing. Bime patients over the long term, even with later disease did extraordinarily well. It's just also that when we treat patients earlier with bime, they do even better. So by works, whether it's late or early. But yes, we definitely, for the reasons I mentioned earlier, want to find patients early and treat them earlier with the treatments we think will do the best for them. I would say this might be practice-specific, but to me, the bolus of patients have come to me not because there's all of a sudden a new drug available, but it's because the diagnosis is becoming more apparent to the medical community and to themselves. They're asking themselves, I have this boil. It keeps coming and going. It's starting to form scars. I've seen this thing about HS, could I have it? And if this is a skin condition, well, now I finally figured out what the right doctor to go to is for this problem. And then they get the diagnosis, which in our hands is readily apparent. And then it's again, did we -- can we find you even earlier? How do we get you on the right path with treatments that will give you the best outcomes. So the fact that there are new treatments is helpful for me because I can tell you 3 years ago, 2 years ago, I was not infrequently having the conversation. I don't know what else to try. I'm not sure where else to go. And that -- that's an exhausting -- psychologically, just an exhausting conversation to have with HS patients. I'm not having that conversation very often. I can't remember the last time I've had it. And and having now a third option that addresses a different MOA than the other 2 with the long-term data to support the rationale for it for my large referral center practice has been a bit of a game changer because we don't have to have that type of conversation anymore.