We'll continue with the next session. I'm Paul Choi, I cover the mid-cap biotech sector here at the firm. It's our pleasure to have UroGen here for this session. Joining me is Liz Barrett, CEO. Maybe what we'll do, Liz, is let you kick it off with maybe some high-level comments on what are your strategic priorities for the remainder of 2026 and going into 2027, what are you seeking to accomplish with UroGen here over the near term? No, great question. I'm glad you started it with what's your sort of strategy and focus, right? I think one of the things we're starting to do is shift actually from the very, very near term to more of a longer-term look at the company and where we're going as a company. As you know, most people know, we launched ZUSDURI, which was our second medicine, which has been in the works for longer than I've been with the company, that's been over seven years now. That finally launched last summer, but more importantly, we got our J-code in January. While we have been laser-focused on ensuring the commercial success of ZUSDURI and obviously JELMYTO as well, that's a key driver for us. We're very confident in that success. What that success will allow us to do is actually invest in the company to build a long-term sustainable growth company, which is really what we want to do. We're squarely in the uro-oncology space right now. Ari likes to say we're urologists who developed a company for urologists, right? We are, but at the same time, we do also have our eye on expanding and diverse our near-term 2026 accelerated adoption of ZUSDURI, at that point, that allows us as a company to be able to turn around and invest in longer-term growth. Great. For those listening in, by Arie, I think Liz means Arie Belldegrun. Yes. chairman of the company, just for anyone listening in. Let's start with ZUSDURI here. You had an excellent first quarter with the launch. Maybe you can just sort of remind us how ZUSDURI did. I think it's already sort of performing better than JELMYTO is a couple years into that launch. Yes. The trajectories of the two products are very different. What do you think is, maybe in your view, driving the early adoption here? There's a few things. I think it's important to take a step back and think about JELMYTO in the context of it's a rare disease, but it's a rare disease that's dispersed among all urologists. Unlike other rare diseases where you have about 6,000 patients in the U.S., a typically rare disease gets treated by a handful of physicians. Here, with JELMYTO, you have a disease that gets treated by every urologist. They may only see one or two patients a year. To your point, what's really different with ZUSDURI are two things. One, there's 60,000 patients, and now we're talking about 10 times the number of patients, so any one doctor sees several of these. We've been talking recently, we actually have one doctor in New York City who's already treated 20 patients. You have doctors who see a lot of these patients in any given year. There's a lot more patients. Also, the medicine is easier to give. It's a very simple procedure. Unlike JELMYTO, which you have to have a fluoroscopy or you have to have a nephrostomy tube, this is a simple installation into the bladder. The patient comes in, it's an outpatient, they don't need to have any general anesthesia or anything like that. It can be given by a nurse. They don't have to sit there and most intravesical therapies, they have to sort of say, "How long can I hold my urine?" They don't have that. Because the gel solidifies, and they're able to deliver the medicine over several hours, so it's much easier to give. Between the fact that the data, we believe, is unprecedented when you look at it from an 80% complete response rate, 80% of those patients still in response at 12 months, and we just recently shared our 36-month data. Yeah. With 65% of those patients still in response at three years. I think you have the compelling data, you have the ease of use, and you actually have a lot of patients out there. Can you maybe provide some color on what your sales force is hearing, I guess, a few quarters into the launch here? Just first on how it's being utilized, what sort of ablative or adjuvant use are you seeing one versus the other? I'm just sort of curious how doctors are using it versus what's on label. Right. Well, actually, I would say on label, our label, the indication is for low-grade intermediate-risk non-muscle invasive bladder cancer, right? It doesn't specify anything more than that from a label perspective. We do know, and this is all anecdotal, that some physicians do use it after they've done surgery. Mostly we're shifting toward the primary use, and that is using it without surgery. Because one of the greatest benefits is you don't have to have surgery. Yeah. These are patients, unfortunately, who have had multiple surgeries. That clearly hasn't worked for them because they continue to recur. Even though physicians may use it in an adjuvant setting, again, we see the shift. Sometimes they want to do that first because maybe they get a little nervous. "Well, I better go in, make sure it's low-grade." As they're getting experience with it, they become more comfortable in not doing surgery and using it as a primary. We believe that, again, one of the greatest benefits is not having to do surgery. If you can be in a situation where you can get the type of response and the type of durability that you're seeing with ZUSDURI without doing surgery, that's a big benefit for patients. Look, in the beginning, it's typically what you would expect in any oncology drug. They start with your harder-to-treat patients. They start with those patients that have had multiple TURBTs. They start with a patient that they don't want to take to the operating room. What they're seeing so far are good results. That then said, let me see how it works, and we're hearing really great experience. We actually had a patient at AUA. We did an event. Yeah. As you know, you participated. We appreciated your participation there. The patient had been through three TURBTs, 25 doses of intravesical gemcitabine, and still was recurring. She got a complete response after only six doses of ZUSDURI. Those are the type of patients that we're hearing about, and it's just great to see that even in these harder-to-treat patients, ZUSDURI is working. I am sort of also curious, relative to the clinical trial population. Yes. Are you seeing, in terms of the patient types you're seeing, are you seeing any first recurrent use? That would be super interesting, and that would be a great leading indicator, obviously. Sure. For the product. I was just curious in terms of the target patient population, what you're seeing. I think you're right in the sense of, in our clinical trial, most of those patients had only one or two recurrences. Like I said, it's typically in an oncology drug, you start later. Yes, we already know that we have some doctors that are real adopters, and they're real champions because they have bought into this approach as a better approach for their patient. They actually have put into place in their practices that any patient who is a recurrent low-grade or intermediate risk patient should get ZUSDURI or should at least have the option to get ZUSDURI. What you want to do is you want to have a shared decision-making with the patient. They want to share. Yes, a lot of physicians we're starting to see shift to let me try it on one or two patients. They see good results, they're going to open it up to their entire patient population. To your point, we want to make sure that everybody who can benefit has the ability to benefit from our medicine. Great. Can you maybe comment on the types of practices or centers where you're seeing initial use of ZUSDURI compared to JELMYTO? How much of the utilization is academic or large hospital-driven versus large group practices or community practices? Just where's the strongest adoption- Sure. In the early part of the launch? In the beginning, before there was a J-code, it was mostly institutions. That makes sense, right? Because they don't worry as much about reimbursement. The pharmacy worries about that. The doctor doesn't worry about that so much. Now we've seen it shift. It was already at 50/50, and we're seeing it even more than 50% of it is in the community practices. That's where most of the patients are. Again, low grade, intermediate risk. These patients are treated in the community setting, particularly to your point in the large group practices, because you still have some reimbursement concerns in your onesie-twosie doctors that say, "Oh, I don't know if I want to put just in case something happens." We actually are working to ensure reimbursement confidence. As we do that, the large group practices are the ones who are adopting more than you see the smaller groups, and that's what we need. That's where the patients are being seen. You are seeing it kind of across the board. Definitely our biggest opportunity is in these large group community practices, and we're seeing the shift go there. Great. Can you maybe speak to how you took your learnings from the JELMYTO launch and adapted it or evolved your commercial strategy to sort of hopefully ensure success for ZUSDURI this year and in the coming years, and just sort of what your bigger learnings were from your first efforts at commercialization? Yeah. I think the biggest, I would say, miss for us with JELMYTO was really understanding the rare disease nature. Unfortunately or fortunately, we don't deal with that with ZUSDURI. That was the hardest learning, was that these patients and practices don't want to change the way that they practice for one or two patients a year. That was a learning that we got out of JELMYTO. The second piece is you have to make it easy on the doctor's office. You have to integrate it. What we do, we have regional operations managers now. They work very closely with the office to ensure that seamless integration into the doctor's office. Even though we had that, we didn't have that role, but we knew that there was these logistical challenges with JELMYTO. There's not as many logistical challenges with ZUSDURI, we are doing everything. The second thing we're doing is going to patients. I think we really do believe that this is the most patient-friendly therapy for patients with this disease, we want to make sure that we educate patients. You can do that when you have a little bit of a larger group. Again, the rare disease nature of JELMYTO doesn't allow you to really find those patients. Very difficult. We definitely learned quite a bit during JELMYTO and ensuring that we are covering the logistical and reimbursement challenges. We have field reimbursement managers. We have, again, ROMs, what we call regional operations. We also have clinical nurse educators. We actually, you think about the reps, we hear often about, well, how many reps do you have? What's important is we probably almost double the number of customer-facing roles when you add all of these others into it. Great. When I look at your reimbursement literature for ZUSDURI that's out there and how to sort of code it in terms of HCPCS codes, ICD-9 codes, ICD-10 codes, excuse me, and so forth. Can you maybe talk about anything else that you're doing to make the experience and sort of drug access frictionless for the providers? How much time is your team spending in doctors' offices versus sort of virtual training and just to help them figure out how to do the paperwork correctly and get it approved on the first try there? Look, I think you can only do so much when it comes to that because you are right in the sense of you're really depending on the office to ensure that the patient enrollment form is complete and all of these things. We talked earlier about compressing the amount of time between a patient enrollment form and the patient actually getting the medicine. One of the biggest challenges, to your point, is actually filling out the form. Our team, again, very hands-on, very much a white glove service, making sure that doctors understand, and if there is missing information, we get flagged. So that you can go right back to the doctor's office and ensure that you have. There's a lot that goes behind the scenes that most people don't know about or hear about, but there's a lot that goes on the scenes. We weren't worried. We even had a challenge, with one of the Medicare payers that was taking a really long time. When we hear about that, we're proactive. They are down there not only working with the office, but working with the payer to say, "Hey, look, they're holding up patients because of reimbursement." Just ensuring that we're educating the payers as much as we're educating the office staff, to your point. We really do have kind of what I call surround sound when it comes to supporting doctors' offices. We have specialty distributors. We have a mixing pharmacy. We're bringing a specialty pharmacy on. It's not a big portion of our business, but some of your onesies, twosies just prefer to use a specialty pharmacy. That's coming on board. Everything we can do, again, to make it easy for the doctor to adopt. Great. I want to talk a little bit about the patient experience and the patient journey. Yeah. In a scenario, let's say if a patient has some sort of medical event that disrupts their treatment installation schedule, or goes off on vacation or something like that, how does it work? Can they still continue their treatment under the initial authorization? Does a doctor have to go through it again, or is it sort of covered under that first go? It actually depends on the payer, and it depends on the time, to your point. If it's just, "I wasn't feeling well, I missed a week," no big deal. Most payers will give a certain time frame. Even though it's supposed to be six-weekly doses, maybe they'll say, "Well, it has to be done within 10 weeks." If it's outside of the 10 weeks, then yes, they have to get re-authorized. What's really important in what we do, because almost all of your community practices, they want the drug already mixed. We provide that service for them free. It's built into our own gross to net, so our own cost of goods. We bring it to them mixed. If something happens and they get it mixed, they have seven days from the time it's mixed to instill into the patient. We have a returns policy if the patient doesn't show up and they can't use it within that seven days. We haven't had to use that very often, which is good, but it's there, and it gives them the confidence. Absolutely, the devil's in the details when it comes, unfortunately, to reimbursement. That's, I think, the difference, the other thing we've learned, to your point, urologists are not oncologists. Oncologists, they have this down to a science because they've got the infrastructure in place. They have the staff because they've been doing buy and bill drugs forever. 70% of their profit comes from buy and bill drugs. That's not the case with urologists. This is fairly new to urologists. They need some hand-holding. They don't necessarily have all the staff in place. You really have to ensure that they're educated on the reimbursement process, that they understand their own personal contract with the payers because, again, it's different. I mean, think about it from our own healthcare, right? Yeah. My healthcare plan is different than your healthcare plan, even though we could have the same carrier, but every plan is different. When it comes to those types of things, and that's why, again, we make sure that we have not only our sales rep who's responsible for ensuring the accelerated adoption, but we have other services available. Enough time may not have quite passed for this to happen, but I'm just sort of curious how you and physicians in the field are thinking about retreatment with ZUSDURI for someone who may have a recurrence down the road. It's only been a few quarters, there may not be many instances of this. Right. I'm just sort of curious what you're hearing from your sales force or in the field about how docs are thinking about repeat use in a patient who may have a recurrence. Yes. I think right now what we're hearing from doctors is that they are very comfortable retreating. It's within our label. There's nothing that in our label says you can't retreat. We don't have data around retreatment. From our perspective as a company, one of the things we want to do is generate that data. You're right, that takes time. You have to have patients who start to recur. The good news is they have a very long durability. As they start to recur, we will either through our own phase IV study, through a registry. We have a registry for JELMYTO. We're more likely than not to have a registry for Cysview in UGN-103 as well. The nice thing about a registry is you can really capture data. We are hearing from docs, as long as they've had a good experience when they recur, then they're likely to retreat. Great. I want to talk a little bit about the AUA meeting, which just- Yeah. Occurred. I guess, from your perspective, what was sort of the level of awareness of Cysview there? How many sort of docs, I guess, or what was your sense of how many docs are like, "Oh, now it's available," and this is something I'll start to use, maybe starting there? Absolutely. Not only at AUA, we had a great AUA meeting there. It was our real first AUA meeting since the approval of Cysview- Yeah. Because that was last summer. Even though it wasn't new, it was new in a lot of ways. Physicians' feedback has been very positive. We've done our own ATU in addition to the anecdotal information from there that 92% of docs say that they will use Cysview, so at one point in time. 100% of doctors, and this is newly off the press, 100% of doctors that have used it have said that they'll use it again. That's just in our recent survey. It wasn't at AUA, but it's our recent own information that we have. We're seeing, which tells us, okay, they're happy with the experience. They're happy with what they're seeing. We're getting very positive responses. We seldom ever talk to a doctor who says, "I'm not going to use this." Right. You do have your continuum of adoption that I always talk about. Those that I mentioned, the doctor in New York that has seen 20 patients. He made the decision that every recurrent patient is going to get ZUSDURI. You have the other end of the spectrum which says, "Oh, I'm only going to use it in those limited patients that I just can't take to the operating room." You have everybody in between. Our job, as you know, is to move all of those that are on the- left over to the right so they're comfortable, and that's what we're hearing so far out in the marketplace. We don't hear a lot of, "I don't know anything about it." Maybe they don't know the data exactly, and I think it's important. Unfortunately, we rarely have to talk about the clinical data, but you want to make sure you talk about the clinical data because it really is very compelling. We have to remind them, oh, 80%. Because yes, they may know about ZUSDURI, but do they really know the data, the clinical data? Ensuring clinical conviction, it's around the logistics. It really ends up being around that. Great. You mentioned earlier you presented a patient story at AUA, of a woman who had multiple recurrences, went through multiple surgeries, multiple treatments before ZUSDURI, but now has a complete response. You also noted that this is an interesting case because she had multifocal disease. Yes. As well. I'm just sort of curious. This wasn't something, to my recollection, that was specifically analyzed in your clinical study, but as you think about this, does ZUSDURI make the most sense for these kinds of multifocal cases where, just given the sheer number of lesions, something like surgery or laser ablation may be potentially clinically challenging here? You're absolutely right. I'll say two things about that. One, if you do look at our clinical data, you'll see that ZUSDURI worked across all patient types. You will also see that the majority of patients, and not just in our clinical study, but overall, the majority of patients that recur do recur with multifocal disease, right? That makes it very difficult to ablate the tumor. The chemoablation makes sense. It makes sense because it's seeing the entire bladder. You're able not only to get to all of the multiple tumors, but you're also able to get tumors you can't see. From a physician's standpoint, a surgeon, you can only cut out what you can see. You're right in the sense of it makes a lot of sense, but that doesn't mean it doesn't work for other types of tumors. I think that's interesting. We have to make sure that we don't get niched. Even though it's the majority of the patient population, you don't want physicians or patients to believe, well, just because I have this type of tumor, ZUSDURI probably won't work because so far we haven't seen that in our clinical data, and we haven't seen it in real practice. Although it's good to know that most patients that do recur with these multifocal smaller tumors, which are harder to treat by a surgeon. Great. As we look ahead, can you maybe tell us how you're thinking about penetration, both in terms of breadth and depth of your target prescriber population? Where are you now in sort of that hierarchy or tiering of a prescriber base and just sort of maybe update us on where you are in terms of depth and breadth versus how you're targeting that over time. Oh, yeah. Absolutely. The interesting thing for us is there's 8,000 urologists that we call on. That captures about 90% of the patient population. As you know, they're not all created equal. You're absolutely right. You have your higher decile doctors. What we are doing is we definitely focus on those higher decile doctors, and we do need both breadth and depth. We have identified sort of our top 250, and if you take those top 250 accounts and ensure that not only do they have the trial, but that they're really treating multiple patients. How do you get multiple patients out of these high-prescribing doctors? Absolutely one of our core strategies. That's the sort of short-term focus. We also cannot forget that we'll never get there if you don't have the breadth, right? When we talk about ZUSDURI being a $1 billion-plus revenue medicine, you're looking at less than a 20% penetration to get there. That's why we always have the plus on the end. We believe that we're fairly conservative to get to that number. So far what we're seeing is really giving us confidence that we will get there. To your question, Q1, we more than doubled the number of doctors. We're continuing to see more doctors coming on board. We've talked about into Q2. We saw Q1, a lot more not only physicians trying, but physicians using it more than once, but we see our patient enrollment forms. We see our new patient starts and our doses, which had already eclipsed, to your point earlier, JELMYTO. We're continuing to see that growth in Q2. We believe that we're right on track with where we expect it to be. Right now, we're comfortable with where the market is looking and seeing where we'll be, and we think that we'll see by the end of the year that we're really on our way to hitting that adoption. Great. Let's turn to the pipeline and maybe talk about UGN-103. Sure. Can you provide an update on sort of what the filing status and plans are and just sort of how you're currently thinking about timelines for 103? Sure. UGN-103, as you know, is the next generation for ZUSDURI, and we also shared not only the 36-month data for ZUSDURI, but the six-month data that we got in, and the great news is it's very consistent. We expect to file within Q3. By the end of Q3 this year, we will file with the FDA. We've gotten approval from the FDA, an agreement with the FDA, that we can update the 12-month data during the filing, so during the review. It won't hold up the filing at all. Our date starts, the 10-month review will start when we file, even though we'll have an update during that time period. Assuming that it remains consistent, which we have no reason to believe. Yeah. That it won't, you're looking at approval sometime in 2027. What we will do is to ensure reimbursement, is we will have both products on the market until we get our J-code for UGN-103. At some point, we will do a swap, and we'll do the switch. When we do that, we'll pull ZUSDURI off of the market. We expect, again, there not to be a lot of clinical differences, but there are some meaningful preparation differences. There's the life of the drug, once it's mixed, will be longer and with UGN-103. There's definitely some practice benefits to it. We expect the clinical data to be very similar, but UGN-103 to have other benefits along with that. Ensuring supply, which is a big deal these days, basically because we know that the maker of the new mitomycin is well known, it's been around for a long time, has the capacity that we need to ensure that we have supply for the long term. That's the plan right now. We don't have an exact date on when we will do the switch because we will, again, make sure that we have our J-code in place before we do anything. The worst thing that could happen is a patient doesn't have access to one of our medicines. Yeah. At the appropriate time, and my expectation, that'll be in 2028. Okay. Just on the J-code mechanics, you talked about for the filing side, filing in the third quarter, which I think investors agree would support an approval in the later part of 2027, under normal review. Then just on the J-code mechanics, is that something you could potentially have in place for the start of calendar 2028? Yes. Okay. That's the expectation. Okay. That's the expectation. Okay. I guess, with that code being available, just in terms of supply that you mentioned earlier, how do you think about building up supply for that at that point? Because presumably, the prescriber base for ZUSDURI will be meaningfully- Yes. Larger than where it is right now in a year and a half's time. Just how do you think about launch supply, I guess, and just having enough supply on hand- Well- For that switch? For both, right? Yeah. For both, yeah. That will definitely be an art and a science as we start to look at ensuring ZUSDURI supply, that we don't run out of ZUSDURI, at the same time we will ensure that both of our manufacturers, the manufacturers for ZUSDURI and for UGN-103, that we have enough supply. The good news is both we have very great partners in manufacturing, and so we will, to your point, build up supply. At some point, we will need to make the switch, right? We will have to ensure You've said it, by that time, we expect ZUSDURI adoption to be much greater. We will not make that switch, and we'll not take ZUSDURI off the market until we ensure that everybody can be supplied with our product. We talked about some features, including longer shelf life. Yeah. For 103, which should be helpful for practitioners. Any other things that you would highlight for us as you think about brand and creating brand awareness for 103 down the road that you think would drive sort of natural preference share for 103 versus ZUSDURI? I think definitely in the institutions, because it is easier to mix. There is, again, an art and a science to mixing the gel with the mitomycin today. It takes longer. It actually is pretty intense from a personnel perspective. UGN-103 is much easier. It's much faster to reconstitute, and you don't have as much because it's more soluble. One of the biggest issues is particles. You have to make sure that it gets mixed a certain way. That will be particularly in the hospital pharmacy. Because most of, as I mentioned before, the community practices, they want it pre-mixed. For them, the longer shelf life will be very key. That will be very important because they'll be able to keep it if a patient doesn't show up. They'll be able to keep it mixed for longer. Absolutely for the personnel and the amount of time, look, they take that into consideration when they think about cost. The cost of reconstituting, the cost that their staff has to spend on, that's a cost to them, and they add that cost when they're thinking about using any therapy. It's like, okay, that comes into their cost of goods. They'll save time from there as well. Those types of benefits are important. While they may not hit the clinical piece of it absolutely matters from a practice perspective. I want to look down the road a little bit and think about your development plans for UGN- Yes. 103. Specifically, how are you thinking about a potential trial in the adjuvant setting? I'm also curious how you're thinking about designing and what's required to move it down the risk curve into a higher risk population, maybe a muscle-invasive population where some other companies are studying developmental candidates there. Yeah. We really believe that UGN-103 will be able to provide benefits for patients with high-grade disease, to your point. That market is getting more crowded. The clinical, we actually have already interacted with the FDA, so we know what we have to do. It will be an adjuvant in high grade, and it will be against a control arm. Right now we're just finalizing the details as well as the patient population, because the interesting thing about high grade is that talking about, oh, high grade now, muscle-invasive bladder cancer, there's so many different types of patients within there. There's the BCG responsive, there's the BCG unresponsive, there's the BCG exposed. Which patient population do you go into? We're finalizing those details, we expect to start that study this year. That high grade, we're really thinking about papillary-only disease because everyone else, if you think about where they've been, is with CIS, with or without papillary. Yeah. It makes sense that our approach works in that patient population. That's when we'll be kicking that off. Again, it will be a control study against not only TURBT, but TURBT +. The question right now is what's the plus? Working with the FDA, and I don't know if you heard it, but there was a five-hour meeting right after AUA with people from the FDA getting input. I think what came out of that is that there's actually no real standard of care right now. There's not one way of looking at it. There's options available. We'll move into that space. We also think about muscle-invasive disease in combination. What are the best combinations? We think about that, we're working on that. Lastly, what we've talked about is I want to be very careful in the IR space with adjuvant because, of course, we believe the drug will work in adjuvant, but we also believe that one of the greatest benefits of our drug is you don't have to do a surgery. Yeah. I do think that some physicians, there's going to be a group of physicians that want to use it earlier in the disease. We want to generate data in the low-grade IR and then make a decision. Do we want to have a pivotal study in that space? Do we want to generate data, ensure that it's positive, which we believe it will be, and then make a decision as to whether we want to go forward with a pivotal study? We're working those final details out, but a lot of room for UGN-103 across the continuum of patients, mostly non-muscle-invasive bladder cancer, but there's a real story to be had, to your point, for even going into muscle-invasive bladder cancer. We have one minute left. I just want to touch briefly on your 501- Yes. oncolytic virus program and just maybe remind us what are the milestones over the near term for that program and just how you're thinking about the cadence of updates to the street for 501. Absolutely. Very excited about 501. The more data we generate, even though it's pre-clinical data, the more excited we get. We believe it's very differentiated from a perspective that it not only elicits an immune response, but it also has direct cancer cell kill. The ability for that drug to be very meaningful in the high-grade space. We are going into our phase I this year. We will be in patients this year. We'll have a broad patient population for our phase I as we do our dose finding study, mostly safety, but we expect that we'll see a signal. There won't be any updates, obviously, in 2026, but there should be updates in 2027 as we move that forward. The other good thing about UGN-501, when we talked earlier about our long-term strategy for the company is we believe it will work in other tumors as well. We know from the work that was done at IconOVir when they had this product, that it will work across other tumors. Right now we're looking at what is the best next tumor to look out outside of urothelial cancer. Again, stay tuned on 501, but I would suffice it to say we're very excited about what's happening in that space. Great. I think we're at time, we'll have to stop on that note. My thanks to Liz and UroGen for joining us today. Thank you, Paul. Good to see you as always.