UroGen Pharma Ltd. Aktie

Okay. We'll continue with the next session. I'm Paul Choi, and I cover the mid-cap biotech sector here at the firm, and 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? And what are you seeking to accomplish with UroGen here over the near term?

No, great question. And we -- I'm glad you started it with what's your sort of strategy and focus, right? Because 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 and 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, and that's been over 7 years now. And that finally launched last summer. But more importantly, we got our J-code in January.

So while we have been laser-focused on ensuring the commercial success of ZUSDURI and obviously, JELMYTO as well, and that's a key driver for us. We're very confident in that success. And so 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. And we're squarely in the uro-oncology space right now. Arie likes to say we're urologists who developed a company for urologists, right? So -- and we are. But at the same time, we do also have our eye on expanding and diversify our near-term 2026 adoption of ZUSDURI because at that point, that allows us as a company to be able to turn around and invest in longer-term growth.

Great. And for those listening in by Arie, I think this means Arie Belldegrun, the Chairman of the company, just for anyone listening in. Let's start with ZUSDURI here. You had an excellent first quarter with the launch. And 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 of years into that launch. And so the trajectories of the 2 products are very different. What do you think is maybe in your view, driving the early adoption here?

There's a few things. And 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. So unlike other rare diseases where you have about 6,000 patients in the U.S., they typically -- rare disease gets treated by a handful of physicians. Here, with JELMYTO, you have a disease that gets treated by every urologist. And so they may only see 1 or 2 patients a year.

To your point, what's really different with ZUSDURI are 2 things. One, there's 60,000 patients. And now we're talking about 10x the number of patients. So any one doctor sees several of these. And we've been talking recently, we actually have one doctor in New York City, who's already treated 20 patients. So you have doctors who see a lot of these patients in any given year. And so there's a lot more patients, but also the medicine is easier to give. So it's a very simple procedure. So unlike JELMYTO, which has to -- you have to have a fluoroscopy or you have to have a nephrostomy tube, this is a simple installation into the bladder.

So 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. So 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 with 65% of those patients still in response at 3 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? And just first on how it's being utilized? What sort of ablative or adjuvant use are you seeing versus 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. But 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. And these are patients, unfortunately, who have had multiple surgeries that clearly hasn't worked for them because they continue to recur.

So 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. So we believe that one -- again, one of the greatest benefits is not having to do surgery. So 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.

And so 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. And what they're seeing so far are good results. So that then -- so let me see how it works, and we're hearing really great experience.

And we actually had a patient at AUA. We did an event. As you know, you participated. We appreciated your participation there. And the patient had been through 3 TURBTs, 25 doses of intravesical gemcitabine and still was with recurring. And so she got a complete response after only 6 doses of ZUSDURI. So 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. 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, for the products. So 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 1 or 2 recurrences. But like I said, it's typically in an oncology drug, you start later. But 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 is a better approach for their patient. So they actually have put into place in their practices that any patient who is a recurrent low-grade intermediate risk patient should get ZUSDURI or should at least have the option to get ZUSDURI because what you want to do is you want to have a shared decision-making with the patient. So they want to share.

So yes, a lot of physicians were starting to see shift to let me try it on 1 or 2 patients, they see good results, then they're going to open it up to their entire patient population. And 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 sort of academic or large hospital driven versus sort of large group practices or community practices? Just sort of where is the strongest adoption in the early part of the launch?

In the beginning, before there was a J-code, it was mostly institutions. And 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. But now we've seen it shift. It's 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, I don't know if I want to put just in case something happens.

So we actually are working to ensure reimbursement confidence. But 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. So you are seeing it kind of across the board, but 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 evolve 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 on commercialization?

Yes. I think our -- the biggest, I would say, miss for us with JELMYTO was really understanding the rare disease nature. So unfortunately or fortunately, we don't deal with that with ZUSDURI. And that was the hardest learning was that these patients and practices don't want to change the way that they practice for 1 or 2 patients a year. And that was a learning that we got out of JELMYTO. Plus the second piece is you have to make it easy on the doctor's office. You have to integrate.

So what we do, we have regional operations managers now. So they try -- they work very closely with the office to ensure that seamless integration into the doctor's office. And so we -- even though we had that, we didn't have that role, but we knew that there was the logistical challenges with JELMYTO. There's not as many logistical challenges with ZUSDURI, but we are doing everything.

The second thing we're doing is going to patients. I think it's really -- we really do believe that this is the most patient-friendly therapy for patients with this disease. And so 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. So 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. So we actually -- you think about the reps, we hear often about 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. So 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.

So there's a lot that goes behind the scenes that we typically don't -- that most people don't know about or hear about, but there's a lot that goes on the scenes. And that's there was no -- we weren't worried about invest to ensure that reimbursement confidence. And we even had a challenge with one of the Medicare payers. That was taken a really long time. So 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," and just ensuring that we're educating the payers as much as we're educating the office staff to your point.

So 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. So that's coming on board. So 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. And 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 be -- continue their treatment under the initial authorization? Does the doctor have to go through it again? Or is it sort of covered under that first [indiscernible]?

It actually depends on the payer and it depends on the time, to your point, if it is -- I wasn't feeling well, I missed a week, no big deal. But most payers will give us certain time frame. So even though it's supposed to be 6 weekly doses, maybe they'll say, well, it has to be done within 10 weeks. So if it's outside of the 10 weeks, then yes, they have to get reauthorized. And so what's really important in what we do because we -- most -- almost all of your community practices, they want the drug already mixed, and we provide that service for them free, right?

So it's built into our own gross to net, so our own cost of goods. So we bring it to the mix. If something happens and they get it mixed, they have 7 days from the time it's mixed to still into the patient. We have a returns policy if the patient doesn't show up and they can't use it within that 7 days if they are not -- we haven't had to use that very often, which is good, but it's there and it gives them the confidence. But absolutely, the devil is in the details when it comes, unfortunately, to reimbursement.

And that's -- I think the difference -- the other thing we've learned to your point, urologists are not oncologists, right? 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. That was always the 70% of their profit comes from buy-and-bill drugs. That's not the case with urologists. And so this is fairly new to Uro. They need some handholding. So 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 health care. My health care plan is different than your health care plan, even though we could have the same carrier, but every plan is different. So 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 for someone who may have a recurrence down the road. It's only been a few quarters, so there may not be many instances of this. But 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. So I think right now, what we're hearing from doctors is that they are very comfortable retreating. It's within our label, right? There's nothing that in our label says you can't retreat. We don't have data around retreatment. So from our perspective as a company, one of the things we want to do is generate that data. But 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.

So 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 ZUSDURI in UGN-103 as well. So the nice thing about a registry is you can really capture data. So we -- but we are hearing from doctors as long as they have 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 recurred -- just occurred, excuse me. And I guess, from your perspective, what was sort of the level of awareness of ZUSDURI 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 it's something else, 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 ZUSDURI because that was last summer. And so even though it wasn't new, it was new in a lot of ways. And so physicians feedback has been very positive. We've done our own ATUs in addition to the anecdotal information from there that 92% of docs say that they will use ZUSDURI. So it's at one point in time. 100% of doctors that -- and this is newly off the press, 100% of doctors that have used it have said that they'll use it again. And so that's just been our recent survey. It wasn't at AUA, but it's our recent own information that we have. And so we're seeing -- which tells us, okay, they're happy with the experience. They're happy with what they're seeing.

And so we're getting very, very positive responses. We seldom ever talk to a doctor who says, I'm not going to use it, right? You have your -- 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. Then you have the other end of the spectrum, which is, I'm only going to use it in those limited patients that I just can't take to the operating room. And then you have everybody in between. And 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. And so we have to remind them, oh, 80% because, yes, they may know about ZUSDURI, but do they really know the data, the clinical data. So ensuring clinical conviction and then 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 as well. And so 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 this make -- ZUSDURI make the most sense for these kind 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 2 things about that. One, if you do look at our clinical data, you'll see that ZUSDURI worked across all patient types. But 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? And so that makes it very difficult to ablate the tumor. So the chemoablation makes sense, right? It makes sense because it's seeing the entire bladder. So 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. because from a physician standpoint, a surgeon, you can only cut out what you can see.

So 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. And I think that's interesting, we have to make sure that we don't get niche. Even though it's a majority of the patient population, you don't want physicians or patients to believe, well, just because I have this type of tumor, the story 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 note 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 prescriber base? And just sort of maybe update us on where you are in terms of depth and breadth versus how much -- how you're targeting that over time?

Yes, absolutely. I mean the interesting thing for us is there's 8,000 urologists that we call on that captures about 90% of the patient population. But as you know, they're not all created equal. And you're absolutely right. You have your higher decile doctors. So what we are doing is we are definitely focused on those higher decile doctors. And we do need both breadth and depth. But 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. So how do you get multiple patients out of these high prescribing doctors, absolutely one of our core strategies. And that's the sort of short-term focus.

But 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. So we believe that we're fairly conservative to get to that number. And we -- so far, what we're seeing is we're really giving us confidence that we will get there.

And 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 in our doses, which had already eclipsed to your point earlier, JELMYTO. We're continuing to see that growth in Q2. And so we believe that we're right on track with where we expect it to be. Right now, we're comfortable with kind of where the market is looking and seeing where we'll be. And we think that we will 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. 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 time lines for 103?

Sure. So 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 6-month data that we got in. And the great news is it's very consistent. And so we expect to file within Q3. So by the end of Q3 of this year, we will file with the FDA. We've got an approval from the FDA, an agreement with the FDA that we can update the 12-month data during the filing. So during the review. So it won't hold up the filing at all. So our date starts, the 10-month review will start when we file, even though we'll have an update during that time period.

So assuming that it remains consistent, which we have no reason to believe that it won't, you're looking at an approval sometime in 2027. And then 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. And then at some point, we will do a swap, and we'll do the switch. And when we do that, we'll pull ZUSDURI off of the market. So we expect, again, there are 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 with UGN-103.

So there's definitely some practice benefits to it and some -- so we expect the clinical data to be very similar, but UGN-103 to have other benefits along with that and 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. So that's the plan right now. So 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 the patient doesn't have access to one of our medicines. But that at the appropriate time and my expectation will 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 a normal review. And then just on the J-code mechanics, is that something you could potentially have in place for the start of calendar 2028?

Yes. That's it.

Okay. That's the expectation. Okay. And then 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 larger than where it is right now in 1.5 years' time. And so just how do you think about launch supply, I guess, and just having enough supply on hand for that switch?

For both, right?

Yes, for both.

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 don't. So we will ensure that both of our manufacturers and manufacturers for ZUSDURI and for UGN-103 that we have enough supply. I mean the good news is both -- we have very, very great partners in manufacturing. And so we will, to your point, build up supply. But at some point, we will need to make the switch, right? So we will have to ensure to -- you said it, by that time, we expect ZUSDURI adoption to be much greater. So we will not make that switch and will not take ZUSDURI off the market until we ensure that everybody can be supplied with our products.

You talked about some features, including longer shelf life 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 it's definitely in the institutions because it is easier to mix. So there is, again, an art and a science to mixing the gel with the mitomycin today. It takes longer. You have to -- it actually is pretty intense from a patient -- from a personnel perspective that UGN-103 much easier. So it's much faster to reconstitute and you don't have -- because it's more soluble. So one of the biggest issues is particles. So you have to make sure that it gets mixed a certain way. So that will be particularly in the hospital pharmacy. Because most of, as I mentioned before, the community practices, they want it premixed.

So for them, the longer shelf life will be very key. So that will be very important because they'll be able to keep it if a patient doesn't show up, they'll have -- so they'll be able to keep it mixed for longer. And so -- but absolutely for the personnel and the amount of time looking, 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. And so they'll save time from there as well. So those types of benefits are important. While they may not hit the clinical piece of it, 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-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 sort of what's required to move it down the risk curve into sort of a higher-risk population, maybe a muscle-invasive population where some other companies are studying developmental candidates there?

Yes. 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. And it will be an adjuvant in high grade, and it will be against the control arm. And 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 high-grade non-muscle invasive bladder cancer, there are so many different types of patients within there. There's a BCG responsive. There's a BCG unresponsive. There's a BCG exposed.

So there's -- so which patient population do you go into? And so that's we're finalizing those details, but we expect to start that study this year. So that high grade, we are really thinking about papillary-only disease because everyone else, if you think about where they've been is with CIS with or without papillary. So -- and it makes sense that our approach works in that patient population. So that's what we'll be kicking that off. And again, it will be a controlled study against not only TURBT, but TURBT plus. And the question right now is what's the plus.

So working with the FDA, and I don't know if you heard it, but there was a like 5-hour meeting right after AUA with the people from the FDA getting input. And I think what came out of that is that there's actually no real standard of care right now. So there's not one way of looking at it. And so there's really -- so there's options available. So we'll move into that space. We also think about muscle invasive disease in combination, what are the best combinations. And so we think about that. And so we're working on that.

And then 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. But I do think that some physicians, there's going to be a group of physicians that want to use it earlier in the disease. And so 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. So 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 about 1 minute left. So I just want to touch briefly on your 501 oncolytic virus program. And just maybe remind us sort of what are the milestones over the near term for that program and just how you're thinking about the sort of cadence of updates to the Street for 501?

Yes, absolutely very excited about 501. We get more -- the more data we generate, even though it's preclinical 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. So the ability for that drug to be very meaningful in the high-grade space. So we are going into our Phase I this year. So 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. So I don't -- 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. And so right now, we're looking at what is the best next tumor to look out outside of urothelial cancer. So again, stay tuned on the 501, but I would suffice it to say we're very excited about what's happening in that space.

Great. I think we're out of time. So we'll have to stop on that note. Thanks, Liz and UroGen for joining us.

Thank you, Paul. Good to see you as always.

Good morning, everyone. Hi. I'm Liz Barrett, and I'm the CEO of UroGen Pharma. Thank you for joining us today. We're here in Washington, D.C. at the AUA. Very excited to be here, a very exciting time for our company. I'm going to talk to you a little bit through the agenda today, and then we have an exciting agenda for you, and then there'll be an opportunity for Q&A at the end.

So of course, our normal disclaimers here. I won't read them. Thank goodness. We won't have time for that. We wouldn't have time for anything else. The agenda, I'm exciting after I'm going to make a few opening remarks, show you a few slides. I'm going to turn it over to Dr. Schoenberg and he's going to moderate a panel discussion with our esteemed urologists. You'll be excited to hear from them. All of them have had experience with ZUSDURI, and we're very excited about that. But more importantly, actually, I have the opportunity to interview and share with you a story of a patient who has received ZUSDURI and recently received a complete response. So I'm very excited about that, and I think you'll enjoy it. And then again, as I said, we'll have an opportunity for Q&A.

So of course, I'd be remiss if I didn't take an opportunity to brag a little bit about the ZUSDURI. We're very excited, as everyone knows, we had approval of ZUSDURI about almost a year ago. I think we could all -- would love to forget about how that happened, but happy that we're here today. But it is a very differentiated, scalable therapy. And it's important because we've been talking this morning a lot about the large, underserved, highly recurrent disease. And it brought me back to actually when I started with UroGen. And one of the things that I remember most is talking to Mark, Dr. Schoenberg, and talking about the fact that there hadn't been anything in this disease since everyone started using TURBT. And so the fact that we get to pioneer and bring the first therapy to this market is a very exciting time for us.

And as I mentioned and as I think a lot of you know, patients unfortunately have recurrence. It's a history of recurrence. They'll continue to have recurrence throughout their lifetime. And before ZUSDURI, the only thing available to them was surgery, a transurethral resection of the bladder tumor. We're going to talk a little bit about the TURBT today, some of the limitations of a TURBT. And I think most importantly, and I was also talking to Cynthia this morning, our patient, about when I first heard the efficacy and the data and when Mark called, I think the first thing he said is, are you sitting down? Because when we heard about the durability, the efficacy, the complete response rate and durability of, at that time, UGN-102 was a very exciting time for us. We had spent years, as everyone knows, getting to this point. So we are able and we're very excited about the potential for patients to have durable, recurrence-free and treatment-free living. But that's what patients are looking for.

And the other thing, lastly, I'll just say, it fits nicely into how urologists practice. Our Chairman loves to say it's urologists who designed it for urology. And hopefully, it fits very nicely again in the way they treat. So as I just mentioned, first and only FDA-approved medicine for the adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer in our innovative reverse thermal gel. And I think most of you know, our company was founded on the reverse thermal gel being designed because urologists actually identified this unmet need. And what's nice about it, it's called reverse thermal because it's actually liquid when it's cold, so it hits the warm temperature of the body, turns to a gel and sustain releases medicine over a several hour time period. In ZUSDURI, at about an 80% complete response rate and 80% durability of response. But really most importantly, and hopefully, you heard last week in our press release around our 36-month data.

What's most exciting about this is we still have not reached the median. And that means the median duration of response for patients is going to be greater than 36 months. So we're very excited about that, 82% at 12 months, 72% and almost 65% at 36 months. As everyone also knows, we're advancing our next-generation mitomycin formulation called UGN-103. And the great news on Friday, we also announced our 6-month durability, and you can see very consistent data. And we have communicated that we'll be filing our FDA approval for -- during Q3 and expect approval in 2027.

But ZUSDURI is just beginning. We're excited about our company and where we're going from here. So after ZUSDURI, we have a strong portfolio with the potential to deliver long-term sustainable growth for patients and for our shareholders and our company. So we have our UGN-103 and 104 and then an exciting UGN-501, which is our oncolytic virus, next-generation oncolytic virus that we plan to go into man this year. So a very exciting time for our company.

And with that, I'm going to turn it over to Mark Schoenberg to moderate our panel. So Mark?

Liz, thank you very much, and good morning, everybody. It's a pleasure to be here. And as Liz said, at a busy meeting like the AUA this year, it's really nice that we were able to get the attention of 2 -- rather 3 distinguished leaders in urology who have experience with ZUSDURI. I'm joined this morning by Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Urology Alliance in Chicago; Dr. Karim Chamie, Professor of Urology and Director of Bladder Cancer Program at UCLA; and Jennifer Linehan, who is Chair of Urology at Saint John's Cancer Center in Santa Monica. So thank you all very much for coming this morning.

I think probably the way to start this out is since you have experience with this drug, maybe to ask you, how did you decide to use it? And who did you decide to use it in? Aaron, can I start with you?

Sure. Yes. Thanks for having us here to discuss this morning. I think most of us had experience with UroGen for upper tract disease and believed in the power of the reverse thermal gel for ablating tumors. And we've all seen these patients who just come back and it's tumor after tumor after tumor and it's like, okay, now you need another surgery. So I think we've been hearing about this for a while in development phase and trial phase. So it's certainly exciting when they got their approval.

So pretty much as soon as we had the opportunity on a commercial side and independent practitioner, we're making sure we're getting reimbursed for the product. We've been offering it to pretty much everyone who qualifies with low-grade intermediate risk disease. I think it's certainly worth a discussion for all those patients. I think many of them would certainly prefer to have an alternative to surgery. So, so far, patients have done great and excited to be able to use it more moving forward.

Let me follow up on that. Karim, maybe you could comment on this. So specifically, how do you -- when you look at patients whom you think might be appropriate, what are the criteria you use? How do you decide who to offer this?

Yes. I mean I think to a large extent, people who looked at this drug and who it's potentially being marketed for. I mean we all thought, well, TURBT is the most definitive way to treat bladder cancer, and this should really be used for patients who may not be good operative candidates. And I think what we're really seeing is that this drug actually works better than TURBT alone. And there's no reason to limit it to patients who may be still operative candidates. And so to be able to allow the drug to be given to patients who are young and healthy who have no comorbid conditions, but just don't want to go through the trauma of a repeated TURBT every 6 months or 9 months. I think that's what's changed as I've gone through and seen patients with recurrent bladder cancer.

Interesting. So Jen, maybe you can comment on this. I think when this drug first came out, people felt it would be appropriate for a relatively small segment of the bladder cancer population. Based on what Karim said, are you thinking maybe it's appropriate for a larger group of people than we originally appreciated based on the demography of -- that was available?

Yes, definitely. I think it's -- for a lot of patients that have this low-grade intermediate risk, either they're older, right, and they don't want to have a surgery, they'd rather have a chemoablative therapy. If you look at urologists across the country, like a lot of us, if you call any of our offices, you're not getting in for TURBT for at least 6 weeks. Patients want therapy that they can start now in the office. So that was another thing that was a game changer for a lot of my patients. And they would rather do the therapy, see if it worked and then follow up with the TURBT. And if you look -- when I talk to them about the data, they're like, wait, why would I do the TURBT? So...

Interesting. So maybe talk a little bit about how you actually talk to the patients and how do you present this? Because, of course, we've been doing TURBT for a long time, and everybody said, sort of, oh, that's the standard of care. Now there's an alternative. Now there's something that's nonsurgical. So how do you explain that to patients?

So when I talk to the patients, I'm like, listen, you've had this low-risk disease before. This is now the third time you've come back. We're doing a cysto. I'm seeing the carpeting, we get the biopsy. I think it would be a great idea if we just did the ZUSDURI this time and see what we got out of this instead of going back with TURBT because when we do TURBT, you know your recurrence rate is still high. With ZUSDURI, the recurrence rate is going to be much, much lower, and you may never have to have another TURBT. So I think that's what I'm talking to the patients.

Are people coming in asking for this drug already? I mean it hasn't been out for that long. But of course, what is long for doctors and long for companies is a little bit different. The company has had the drug approved for a year almost. But it takes a while for these kinds of ideas to penetrate medical practice. What's your experience been with respect to talking to colleagues and also hearing from patients?

Yes. I think it's -- we're still in the early phase. I think I was talking with someone earlier today, and I said, we would see a sharp rise once all of a sudden, these AI platforms will start counseling patients because patients will go to ChatGPT. They'll go to Gemini and they'll start asking the chatbots, I've got low-grade intermediate risk bladder cancer. What should I do? I keep having recurrences. And I think patients are going to be doing their independent research, and they're going to be coming out to us and probably requesting this. And I think the whole idea of commercials and marketing to patients, I think, is going to change as patients talk to their chatbots more often.

I haven't seen patients come to me requesting this, but I do bring it up to all my patients who have recurrent low-grade intermediate risk non-muscle invasive bladder cancer. And I talked to all of them because I know how -- I used to think that a TURBT for low-grade bladder cancer was not a big deal until I talk to patients and some have been devastated by it. And it's very traumatic. And I think offering them an alternative that avoids that trauma, I think, is meaningful. And I think the demographics is changing. You're asking the demographics. Our patient populations are changing. I mean, we used to think that bladder cancer is a smoking-related cancer. And what we're seeing is that fine, we're -- our patients are smoking less, but the incidence of bladder cancer continues to go up. And so -- and the type of cancers that we're seeing as the incident goes up is these low-grade recurrent non-muscle invasive bladder cancer. So I think the market share is going to grow for UroGen, but I think we, as a urologic community need to come up with these alternatives to treat patients other than just TURBT alone. So...

So there's perception, I don't know if it's a reality, that a modern private practice is very different than academic practice. And Karim's practicing in a big university. Jen's practicing in an academic community setting. How about in a true community-based practice? Do you find this is true as well? How do you -- how are patients responding to this? And how are you talking to them about this?

Yes. I think it's -- certainly, the community practices have also gotten very more sophisticated over the years and a lot of integrations and shared practices and all those kind of things. But I have not had either any patients coming in and asking for ZUSDURI yet by name, but I think you're 100% right, like people will find this and ask their AI helpers or once this gets out more and they'll be interested in this.

And I think the biggest thing that we are dealing with now is really education of colleagues because not everyone comes to these types of meetings in the community setting or is staying up on education. So we -- the main difference is when you look and see a bladder tumor that's recurrent, the reflex for everyone is, okay, let me get my surgery schedule or let's get you set up for your surgery. But -- so changing that mindset that, hey, there's different option, not only for the patients that -- I mean, because a lot of these patients have had this 5, 6, 7 times, at least sometimes. And to say, hey, we're not going to do your surgery. There's this new option that you can avoid surgery will work probably as well or better perhaps. It's a total paradigm shift and not only what the patients are taking in on this front, but also for all my colleagues because we've had several patients, several -- because I get all the approvals for these new bladder drugs and have to review and make sure they're good candidates.

So we've had a few where it's -- they've requested it in the post-TURBT setting. So I said, no, this is instead of like you asked me too late, like next time they have a recurrence, that's the time to bring this up. But at this point, you did your surgery, it's too late for ZUSDURI now. But in the future, like if this happens again for this patient, like you have this great option to move forward.

So it's interesting that you bring this up, and I'm glad you did. How we talk to patients and how we talk to colleagues is obviously a little bit different. When you meet a colleague who is resistant to the idea of using this, of embracing this paradigm change, what arguments do you offer to that doctor?

Well, I think the -- I mean, you brought up the point of the morbidity of TURBT. And I think people don't appreciate that. And for us, it's a pretty easy surgery. A lot of these low-grade tumors, especially recurrent ones. It's a pretty quick procedure for us, but patients still have side effects. They have catheters potentially. They may need medical clearance. They're getting anesthesia. All the stuff that goes along with a quick TURBT for us is a lot for patients. And all those repeated resections, I think, as we all know, is compromising their bladder health and may be getting more irritative symptoms and frequency and urgency and all the things that go along with it.

So I think really explaining that to our colleagues and also showing them data and the effectiveness. And many have had experience with upper tract disease with this product with JELMYTO, and they've seen results. So say, hey, this is -- you had that patient a couple of years ago that got JELMYTO. This is very similar now for bladder. It gets rid of the tumor. So I think that sometimes turns the light bulb on, like this is the same kind of thing.

Yes. Great point. When you think about this drug, obviously, there's no such thing as a drug for everybody. We've talked a little bit about who you think it's for. Who's it not for?

I mean if I have patients that have high-grade disease, if I have patients have very large tumors, those are the patients that I might be thinking more about resection and seeing what's there. But I do have this population of patients that this is not recurrent disease. This is something that I'm finding in their bladder for the first time for cysto, small tiny papillary lesions. I biopsy them in the office. And we actually have a conversation about ZUSDURI. I mean they could be 90 years old and not trying to avoid TURBT. And obviously, I was on a webinar and one of the other urologists was like, well, how do you know it's not high-grade disease? And I was like, well, we get cytologies, I take several biopsies. And they're 90, like they don't want to have a TURBT. This is a better direction for them if things come back low grade.

Yes. Interesting. I mean, I think it is important to remember that the approval is for recurrent disease, and you're describing a situation that is new disease. So that would be obviously a decision you make at the discretion as a physician with your patient, but it's for recurrent disease currently in its labeling. Would you agree with all this?

I do think that it is available for patients with recurrent disease. And I think some people may use it as an adjuvant and some people may use it as a high-grade TA, I mean small volume. I think we're going to be using it for a number of different reasons. And they have their own reasons why they want to use it. But I think, obviously, you got to stick to the label, at least for now until more data comes out. I do think that there is -- I do think that there's a mechanism by which this would be effective even for high-grade TA probably in the future.

Yes. Interesting. Well, there are obviously a lot of opportunities for future research for this type of medication, and the company is very interested in pursuing that. With respect to bringing this drug into your practice, I mean, one of the -- obviously, this fits into a general intravesical therapy paradigm that we're all familiar with. But what's been your experience about bringing this into your practice? And Aaron, maybe I'll start with you thinking not only about bringing it in mechanically into the practice, but financially. What's been the experience there?

I think from the operations standpoint, it's -- I mean, this is not challenging to deliver. I mean I think the UroGen team is for all our first patients going through this. I mean they're helping our staff, making sure the process of the instillation is done properly, but this is not challenging from a operational standpoint. It doesn't take a real long time. Patients can get in and out of the office pretty quickly, which is always a concern for independent practices when our my parking lot is full and patients come and saying, there's no parking spaces. I had to wait. So I think that's always a concern with any treatment. Like are they going to be there for an extended period of time.

So I think that part of it is easy. The installation is pretty easy. I think it's well tolerated. And on the financial piece, we did need to wait -- I mean, this has been approved for, what, 8, 9 months, I think, FDA-wise, but we did need to wait to have the permanent J-code from a billing aspect because certainly, we're paying the full price in the independent practice for this. We don't get special rates as some academic centers may. So it is very important. All these -- there's a lot of new drugs in the bladder cancer world. This is -- certainly, this has with the low-grade intermediate ablative space. This is really it right now, and it's very exciting, but we do need to be conscious of cost. And if you start doing this and you tell your partners, hey, this is a great product, let's do this and not do surgery and then for whatever reason, like the billing side doesn't match up and we're underwater with even one patient have a lot of partners who are very reactionary and I'll say we're done. We're not doing this. And that would be certainly unfortunate.

So we did want to take our time. And I think that the UroGen team was patient and understands that this is how it needs to be for certain practice settings. But now that we have the J-code, we've so far had really no issues. I think the important piece for the independent practice folks that may listen to us who are doing this. Is this not a matter of just learning how to do the authorization process and making sure the documentation is correct that they meet the FDA indication, but you also have your contracting correct. I think we've all seen explosion in Medicare Advantage plans. And I think that's the part a lot of people missed because your Medicare Advantage contract in your individual practice, may not actually reimburse the cost of the drug. So it's covered, but you may actually not get your cost back, which is obviously problematic. So that's the part that really needs to be addressed and remind people of that. But from an operational standpoint, I don't think this is challenging to bring into any independent practice.

I won't ask you to comment on the finances of the University of California, which sounds a little bit daunting. But I was curious to know, at your institution, how has it gone?

Yes. So we have this pseudo academic practice, and my practice is still inside the hospital. But it's gone very well and Neurogen has worked incredibly hard to work us through getting the drug covered working with patients, working with our billing team. And so we've not had any issues. I mean, that started with the JELMYTO as well and now with ZUSDURI. So it's been a good experience, and we haven't had any trouble getting it covered, and we can -- I mean, the patients can start on the drug within a week.

So good experiences, it sounds like, and not a lot of friction. Just a sort of a hypothetical question because you're just beginning to treat patients with this drug now. But you saw Liz's comments about the data for the follow-up of this drug, and it's durability of effect. So it will be a while probably until patients start to recur. But if you have a patient with a good response to this drug, could you envision retreating with this drug? Karim, do you want to take that one starting out?

Well, I mean, you guys are, what, 3 years out. And I mean, that means essentially half the patients that ever got onto this trial have had a recurrence, right? I mean so you got about 80% or so who had a complete response and 3 years later, 65%, 64.5% of those 80% are still cancer free. So you put -- you do the math back of the envelope math. So you've got a path of patients who had a recurrence either initially or subsequently later, 3 years out, which is pretty impressive, right? I mean, for this disease space.

I don't know. I mean, I don't -- I think now that you've hit the 2-year or 3-year time point, I don't know if there's going to be that many more recurrences. I think you've kind of hit a point where it's -- you're not going to have -- that number is not going to be decreasing by much any longer. And I think your median time to recurrence may take 7, 8-plus years to happen. But amongst those that I've seen every single patient that I've assessed with -- that has had cystos had a complete response. If I were given a situation where a patient has a complete response and they go a year, 2 years, 3 years and then they have a recurrence, absolutely, I would reinduce them.

But I think you're making an interesting point. I'm curious to know what Aaron and Jen think of this. It may be changing the biology, the clinical biology of what we're seeing for this disease because we're so accustomed after a surgery to seeing relatively rapid recurrence that may now be changing with this type of intervention. But would you consider retreating if you had a good response?

I think if patients get -- I mean we've had a couple of patients for upper tract disease, like there's not great surgical candidates, they had substantial tumor shrinkage. So I think in a setting like this, I mean, I just had a patient recently who went through their treatments, probably 95% of the tumor was gone. There was like one tiny, like one millimeter little thing that we just are going to zap in the office. We talked about renal reinducing and are trying again. But for that, it's -- that will take me all of 5 seconds to do that. It doesn't require TURBT. So-- but I think if you do have, especially if they had a great response and you're out 2, 3, 4 years later and they have some recurrent tumors again, I think it certainly would make sense that they had a good response initially to give it another try. I don't see why not.

Yes. Jen, any additional comments?

Yes. I mean that's what we would do, I think, with the patients that if it was a PC, if you were giving BCG, even though I'm talking about high-grade disease, I mean, I don't think it's an uncommon oncology protocol that if they responded in a 2 or 3 years out to give them another induction course. I also wanted to say, when you were talking about the feasibility of instilling the drug, the patients actually in my practice like it more because a lot of them have a hard time holding liquid, right? They don't have to worry about that anymore. They get the installation, it turns into the gel and then they can walk out of the office and don't have to sit there and be worried that they're not going to make their 90-minute time limit.

Yes. Yes, it's a nice feature of this, and it does take some of the burden off the patient in contrast to our aqueous approaches historically with chemotherapy. Aaron, I think you brought up the burgeoning field of urologic therapeutics for bladder cancer. It's a brand-new universe with all these new drugs that are coming in admittedly in the high-grade space. But there is some migration into -- or some interest in entering the intermediate risk space.

Karim, do you want to start a conversation about how you view those drugs? And how do you think about them compared to ZUSDURI? If some of them enter the intermediate risk space, how would they compare in terms of how they might be used and how you might think about using them now that ZUSDURI is available as well?

Well, I think first and foremost, I think you want to talk about what UroGen's leadership in this field. I mean, first, they're the first to actually think about sustained release for the treatment of urothelial cancers, right? I mean we had the first sustained release for the treatment of protractothuo carcinoma. You've got a drug that had a 59% complete response rate for the upper tract tumor. It was great. It was up there for a few hours. We've seen the data, the preclinical data, the clinical data. And that was really exciting.

And then UroGen is kind of the first one to go down the road of chemoablative. And they've kind of set the benchmark and the 59% complete response for the upper tract increased to 78% for the bladder. So that's kind of exciting. So the complete response rates have gotten better. And I think UroGen is the only game in town with regards to the chemoablative treatment of patients with low-grade intermediate risk disease. That said, I do think that there's others that are coming in. You got CG Oncology that has their adenoviral technology for the treatment of patients with broad intermediate risk disease. So that includes patients with high-grade TA and recurrent low grade. We don't know what the data looks like. They're waiting for enough events in order to get a data readout. You've got TAR-210, which is the pretzel technology with erdafitinib or an FGFR inhibitor. That's only marketed for patients who have FGFR alteration, which probably 20%, 30%, 40% of non-muscle invasive bladder cancers may harbor. And so we don't -- early data shows that, that may be -- that may have some cumulative properties. So that's kind of exciting. But we don't know yet.

But for the time being, I think UroGen's first to market, and I think they've got significant head start compared to their peers. But I think it's exciting because for a long time, urothelial carcinoma was the red-headed stepchild of all the urologic malignancies and now it's the darling of the room, and everyone is in the field and everyone's developing drugs for it. And it's really exciting us, as scientists and doctors but also for our patients.

For the most part, these therapies that you alluded to are being developed as adjuvants following surgery, which obviously is a big distinguishing characteristic when you compare it to zoster, which is a primary therapy. Jen, when you think about those adjuvant therapies, many of them are given not only as an induction course but also there's a degree of maintenance, they have some of them permit reinduction. That's for the high-grade space. But presumably, it will, in some way, mirror what happens in the intermediate risk space if they migrate into that. How does that burden of treatment figure into your thinking about offering these therapies if they become available to patients, particularly compared to ZUSDURI, which is, of course, 6 doses, and then you're done?

I think any patient would tell you that if they could just do 6 doses and not have to do maintenance therapy every month or every 3 months, they're going to prefer that. So I think for patient feasibility and for patient comfort, that's going to be a much better option. But because it has the chemoablative properties, which a lot of those other drugs don't have or at least we don't know that yet. I think that's the real benefit that they're going to be able to get the drug not only is it going to help prevent the cancer from coming back, but it's going to take care of any cancer that's already in there. And I don't think there's anyone else in the space that can say that.

Yes. Interesting. I know, Aaron, that you've thought about and I think you're participating in trials related to the oral FGFR3 inhibitor that's available. I think it's manufactured by TYRA. Could you comment a little bit on your thoughts about how a pill might compare to ZUSDURI if it enters the intermediate risk base? I mean a pill sounds like a great thing initially, but I don't know, you've obviously thought about this.

Yes. I think -- I mean, just to echo what was said. I mean, it's really exciting to have all these options available the TYRA product, I think, is -- will be a similar indication down the road, assuming the data is positive, but it is for FGFR mutations only, which as you mentioned, is not everybody. And then it really comes down to having that discussion with patients. Pill may sound great. But I think until we get more information on tolerability and safety data. It's really hard to make that determination currently. Certainly, like oral erdafitinib has lots of systemic side effects, which is why it's interesting on the TAR device that it may be a much better option there. But the TYRA, it's a different drug, much better tolerated at least in the early phase data.

So we'll see. I mean, I think as you mentioned, it's another -- it's nice to have options and potentially for patients in the future, like if they go through ZUSDURI and they are not in the fortunate -- the low percentage that unfortunately didn't respond, and maybe that's another alternative. The whole concept of sequencing these drugs, it's getting a little crazy in the high-grade space. We have more treatments than patients at this point. But in low-grade intermediate, maybe that's what's going to happen. Maybe there's some sequencing that eventually happens. And again, I think if we can avoid more surgery for patients and you see some of these new options, I think that's great. But I think patients are having a quick installation in the bladder in the office that they don't have to worry about holding in and don't have a lot of toxicity from, I think, it's still a very appealing option as opposed to potentially some skin issues or nail issues or diarrhea issues or things that can happen with oral immunotherapies.

Thank you for bringing that up because I was sort of where I was going to close out, which is sort of the whole concept of sequencing, which is very hot in our field right now. And it sounds like, correct me if I'm wrong, you're suggesting that ZUSDURI might, in fact, particularly for the recurrent patient considering the label might be the first thing to go to with these other therapies that are being developed as things to follow on with in that small population of patients that don't get an appropriate result with history. Would the 3 of you agree with that? I mean, does that sort of feel correct?

Yes. I mean I'm a little bit more hesitant about a systemic therapy like a pill. I mean I feel like bladder cancer, especially low-grade bladder cancer should be treated locally if you can. But I think for patients, if they did fail, that's definitely options that they want to look into because, again, the recurrence rates are going to be challenging for them.

Yes. Karim?

Yes, I agree with Jen. I think the intensity and the adverse events profile should kind of be commensurate with the lethality of the disease. So I think for cancers that are low-grade, recurrent, I mean I don't think many urologists are interested in giving systemic therapies. Unless, of course, you've got patients who have significant lower urinary tract symptoms and are truly unable to hold it, and they've got pretty bad lower urine tract symptoms that maybe precludes them from getting it. I haven't seen it amongst the patients we've treated. I mean sometimes we skip a dose here or there, but to a large extent, it's not something that I've seen as being very problematic.

So I think most of the patients are going to be able to tolerate it. I think if a patient goes a year or 2 years without a recurrence, I think providers are going to probably retreat with ZUSDURI again. I do think that amongst the patients, amongst the 22% of patients who don't complete response, I think they are going to probably go to something else. I think amongst those patients, they're going to get cycled to a second-line agent, whether it's CG or whether it's TAR-210 or something, I think there is an opportunity for cycling. And I think we, as a field, are becoming more comfortable with it. If we're comfortable doing cycling patients through BCG unresponsive, we're definitely going to be comfortable cycling patients through recurrent low-grade intermediate risk disease.

Well, thank all of you for this wonderful session and for your insight is really valuable. We are now going to be able to move to Liz and her patient interview with Cynthia. And again, thanks for your time and taking time out from the meeting to join us. Thank you.

Thank you.

Hello. Liz again. Nice to be here. I want to introduce [ Cynthia Phelps ] to you. And the first thing I want to do is thank her for traveling all the way from California. Her and her husband got here last evening. And so first of all, thank you for coming.

Well, thank you for having this wonderful drug.

Well, we're thrilled to -- for you to share your story. It's a very compelling story for so many reasons. But before we get into the story around ZUSDURI, tell us a little bit about your family. And then when we spoke before, you actually unfortunately have a history of cancer in your family. But fortunately, everyone's doing well. So please, if you could just share a little bit about your background and your family, that would be great.

I'm a mom and a grandma, 4 grandchildren, and 2 of my children have had cancer. My 36-year-old son was diagnosed with testicular cancer when he was 19 and was treated at UCLA, had surgery, chemo. And then about 2 years ago, it incurred, which is a very low chance of it's happening. But he's all good now. He has a beautiful baby girl through IVF. And this year, my 40-year-old daughter went for her first mammogram, and they discovered cancer. So she had a double mastectomy but no chemo radiation and she's going to have reconstruction. So we've all come through it.

Yes. So tell us a little bit about your cancer. And when you were first diagnosed with cancer, and obviously, you saw Dr. Chamie, so we're happy for him to be here. And I think we were all on pins and needles as we were waiting to see if your ZUSDURI is a complete response and I'm sure you were to. But take us back to when you were first diagnosed.

I was first diagnosed in 2023, and there was just 1 tumor and I had a TURBT and went home, thought, "Oh, it's all done". I went in from my 3-month check and there was more cancer. So another TURBT was scheduled and that one, there was over 60 tumors. And Dr. Chamie removed them all and then decided that I needed to do chemo. So I had many courses of gemcitabine than in August of that same year, another cysto, and there was more tumors. So you get to the point we're just like, more? And Dr. Chamie always kept telling me, it's okay. It's okay. This is not life-threatening. I said -- he said, it's annoying. And I was like, It's super annoying.

So I had another TURBT, more gemcitabine. This time I was like laying on my stomach. I did the trick where you land your stomach for the first 30 minutes and then flip over. And I was like, I'll do whatever I need to do. This is what you do. And then when I had another cysto this past August, and there were tumors. I was like, okay, [ Andy ] said there's something -- we're going to switch -- there's something new, and I was like, there is? And he's like, yes, we might have to wait for it. And we did. That was August and I started in February, and it was so easy I had some side effects with the gem. And there were no side effects. I was like I used to -- being a former kindergarten teacher, I can recognize when children have to go to the bathroom. When I was with the gem, I was like, I'm like a kindergartener wiggling around here, it was hard for me. I counted it down to the last second, so I could run to the bathroom at the office. And there was none of that with the ZUSDURI, it was just so easy. I have about a 2-hour commute back home, able to go all the way home. I think the first treatment, I was like, I got home and I was like, I still don't need to go to the bathroom. And it was like 4 hours.

And then just looking myself at what the drug is, and it just totally made sense to me that, yes, we're quoting work. And it's just -- it was an easy experience for me. Everyone was so nice from the company, and they were always there. And I was -- I still -- I just a week off of my cystoscopy, and I still don't quite completely believe it. It's like no, I can say there's no cancer. I can say there's no cancer.

That must be a great feeling.

It is. It really is.

Talk just a little bit about -- you shared with me some of the side effects of gemcitabine. Obviously, when you're getting in an acreage solution, you have to sit there, the amount of time. But also some the things -- the side effects that you experienced.

I had like some -- well, I just didn't feel -- I explained to -- I felt like kind of a little bit like morning sickness.

Unfortunately, I remember that.

Yes, yes. I just -- it got to the point where I was throwing up and I also had like bladder spasms on my drive home a one time. It was like, okay, I'm stopping. I'm stopping again. I'm stopping again. And at one point, I e-mail Dr. Chamie and said something is wrong here. I can't stop going to the bathroom. So yes, that was not...

Not exciting to have to do that again, right?

No, no. My husband always make fun of me. I traveled -- after that incident, I always traveled with a beach towel, an extra set of clothes. And it was like you don't -- I was taking it back by that experience.

Well, look, we're so thrilled that you were able to get ZUSDURI. Dr. Chamie were talking to him, and he said when he looked in and saw 66 tumors, he's thinking, "Oh, my goodness". And it's just -- we hear different stories about different patients, but it is really, really thrilled that you were able to. And like I said, we were all on pins and needles because to see whether you would and given your situation having after so many TURBTs. Tell us a little bit about a TURBT and how that -- just the procedure is for you or was for you?

Well, it's surgery. You've got to get your clearance from your primary you got to then get clearance from -- there was another doctor and it's surgery, right? You go home, you've been under anesthetic, you're out for a couple of days. I think the biggest thing for me was after the surgery, not lifting anything, I think they told me heavier than a gallon of milk and I'm a very active grandma with my grandkids, and they had to be told no. I can't pick you up.

Yes, I have my first grandmother, actually. Very exciting time. She's 1, but not being able to pick them up, I can't even imagine, right, thinking about that, right?

Yes, it's really hard. And because I felt okay for 4 weeks because you had to do it for 4 weeks, but it was like to not be able to do that right now.

It does impact your life. And it's actually one of the greatest benefits, as you know, we've talked about with ZUSDURI, you don't have to do surgery. So we're really happy about that. And hope that you get the same result that we've seen so far. So you had the 6 doses of ZUSDURI and now it's pretty easy for you. Any side effects?

May be like towards the end of the cycle of treatment, a little bit of pain like but not nothing is bad is like a bladder infection, just still a little bit...

Yes, I thought it was important to share. We had talked about that, look it's great. I'm glad that you didn't, that was very minor, but just in the sense of for people to understand what they might expect and expect to see. So where do you go from here? So you're down in D.C. Your husband is going to spend a couple of days here. And so where do you go from here?

You mean in terms of my treatment?

Yes.

I'm on the 3-month schedule for, I think, a year at least, and then we'll go to 6 months. And I'm just so happy I'm part of that 80% initial and I'm going to be part of that 64.5%, keep going. Absolutely.

That's fantastic. Last -- we just almost out of time, but you talked about there was another person that was having treatment at the same time as you. And that was such a great story. Can you just share that with everyone?

He was patient 1 and I was patient 2. He got it a half hour before me. And when he -- after he had his -- we became friends. I mean, we talked about our kids and where did you go for your second, all the things, and I felt very comforted by him. He was -- he's such a nice man. Just very comforted talking to somebody else about the same situation. And he had his cysto after me, and he sent me a text. And I was at my phone, I said, he must have just walked out of the like, oh, Cynthia, I'm so excited. I just had mine and there's no cancer. I was glad to be able to share that experience with him that we both...

You get to share it together, and that's fantastic. Well, I just want to take an opportunity to say thank you, one, for traveling so far to be with us today. But importantly, for taking the chance on our medicine. We are so thrilled that it worked for you.

I thank everyone at your UroGen for -- this is just life-changing and amazing. And thank you for emphasizing this kind of cancer recurs. It's not life threatening, but it's cancer.

It's life altering, right? Well, thank you. Thank you very much. Thank you for being here. And I think now we're going to go to Q&A. Thank you.

And it's great to be able to hear the patient voice. We spend a lot of time talking about the doctor's voice, but it's wonderful to hear about a patient experience and Liz's interview brought that out. So now we're lucky Liz's joining us for the Q&A, and we'll be able to start that now. So I'll turn it over to Liz.

Yes. So hello, everyone. Before I ask any questions, just wondering, Vincent, do we have some questions from the audience?

Yes. We'll take our first question from Nick Lorusso with TD Cowen.

Question for the position since we have you guys. But now that you've had experience with ZUSDURI, what percentage of patients do you believe would be ideal for this treatment over TURBT? And what are the defining characteristics of these patients?

I mean it's -- I think there's really not, as I think we talked about before. I don't think there's a person that is not a candidate. I mean if they meet the definition of low-grade intermediate risk and have recurrent disease, I mean, I don't see a reason why we wouldn't have that discussion with all those patients. I mean even if they're young and healthy and can get anesthesia and get surgery, like why would you want more surgery? I mean, so I think that the numbers, we've gone through our database of patients in our group of 17, in our kind of pod, we've got pretty long list of low-grade intermediate patients that we're now tracking and finding when they're coming in and making sure all our providers are updated like, hey, this is an option. And it just takes -- with any new product, it takes reminders for -- since I'm not the one doing all the surveillance cystoscopies like maybe in an academic center. So it's just a reminder, but I don't really see a reason why this can be discussed with all patients. I mean who meet the criteria. I mean, I think as we just heard, it works great for patients who've had multiple surgeries like I think this is -- even if they've only had 1 surgery.

Like I'm sure the first TURBT was not a cakewalk. So like say, hey, you don't even need more surgery, let's do this instead. I think that's -- it's certainly something that will be discussed with all patients that meet the criteria.

Nick, I don't know whether Nick is trying to get at the demographics. But if we actually look at the number of patients that have -- that are diagnosed new incident cases of bladder cancer. So you've got 80,000 patients, of which probably about 30,000, 40,000 or probably low grade. And then you've got a cohort of patients that are walking around with bladder cancer are probably like 600,000, 700,000 in America. I think this is probably going to be marketable to maybe tens of thousands of patients with bladder cancer. What that number is, maybe 30,000, 40,000, I don't know. But I think it's in that ballpark because I think this is a highly recurrent disease. And as the population gets healthier as we age, these patients are living longer.

So the competing risk of developing -- the competing risk goes down, meaning they're less likely to die of heart disease because we've got cardiologists and primary care physicians who are taking better care of our patients. So the overall risk of getting bladder cancer recurrence continues to go up. So I think this has a pretty sizable addressable market as we continue to see that you don't necessarily need a TURBT and you're seeing probably better efficacy with regards to recurrence-free survival.

Great. Dr. Linehan?

So I would say 100% of my patients would be candidates for this. If they had low-grade disease with recurrence. I mean, unless there was some kind of allergy or something like that, I would talk to all my patients in that space. And like Aaron said, even if there was one recurrence, I think I would already be bringing it up because it's going to prevent them from having more surgeries, more cystoscopes and more worry, like their overall worry and concern that this is coming back. It's growing inside me and I'm sitting here with this like what else can we do.

Our next question will come from Ram Selvaraju with H.C. Wainwright.

Firstly, I was wondering if I could ask the doctors on the panel, if they could comment on, firstly, how important TURBT is as a determinant of whether or not a patient would be eligible for ZUSDURI or if it is really a situation where TURBT may have been done at least once in the past, a significant amount of information was already obtained from that procedure. And therefore, TURBT does not necessarily need to be done in order to determine whether or not a patient would be a candidate for ZUSDURI.

Secondly, I was wondering if it would be possible to opine on the decision tree that could take place theoretically, within the intermediate risk population that would determine whether or not a patient would get the story versus other therapies that I think as Dr. Chamie alluded to, are coming down the pike specifically aimed at the intermediate risk population and perhaps how BCG responsive or unresponsive status fits into all of this.

And then lastly, perhaps a question for Liz and Mark. How are you thinking not just about the future of UroGen's participation in the urothelial carcinoma in the bladder cancer space with respect to ZUSDURI and UGN-103, but also more broadly across the treatment continuum given not only a drug like 501, but also other elements of your pipeline? And do you ultimately see UroGen as a company, given your existing status as a pioneer in this space, as potentially ultimately evolving into a one-stop shop for all forms of bladder cancer?

A lot of questions there, Ram. Thank you. Thank you very much. I'll ask Dr. Linehan maybe to take to take the first question, and then we could go from there.

Can you repeat the first question? The TUR. No. So you do not need to do the TUR. I mean if this is a patient that has had a consistent history of low-grade disease, you know that you've done the TURBT before. They come back in the clinic, the tumors are smaller. You can also biopsy the tumor in the clinic, which a lot of us do. And so you would have a confirmatory biopsy. So the TURBT is definitely not necessary, and that's the point that we're trying to avoid.

Yes. I mean I think, obviously, the more TURBTs you do and the more you can document that they're low grade, the greater you're comfortable in your own skin that the patient has low-grade disease. But for me, that number is maybe 1 or 2 prior TURBTs that have documented low grade. I don't need 7 prior TURBT to say, "Oh, okay, now we're going to do ZUSDURI". I think probably 1 or 2 is probably the minimum number, I think.

That's great. So maybe the second question, Dr. Berger, if you -- do you want us to remind what the second...

Yes, I think decision tree, I think it will become more complicated, certainly, I mean, assuming these other trials have positive results at some point. But I think this is nice as you don't need to do any additional testing. Like you look in, you see a tumor like, okay, you're a ZUSDURI candidate versus potentially TAR-210 or TYRA, you may need the FGFR testing, which in low-grade disease is pretty high percentage, but it's definitely not all.

We've had some screen fails on trials that they're FGFR negative, and they're not candidates. So I think as we talked about before, it may be where there is some sequencing. I mean no one's figured out sequencing in prostate cancer after 15 years. So I mean, I don't think anyone's going to have a definitive answer on sequencing. No one's going to do a trial to say, okay, the ZUSDURI first and then this, then this. It's just never going to happen. But I think you do what's easy and well tolerated first. And I think that certainly being first to market in this space, certainly is a great benefit.

And I think as a lot of people get familiar with this, when new products come out, that's going to kind of take -- unless the data is overwhelmingly better than this, which I find hard to believe. It's going to be hard to kind of leapfrog over ZUSDURI and say, let's do this first, especially when you need additional testing with the mutations for FGFR and potentially more toxicities. And I think like TAR-210, I think I do a lot of TAR-200s currently. I think it's a great product. But the device is in there for 3 months. Toxicity-wise, how is that going to be versus having ZUSDURI gel there for a few hours. So we'll see. I want to see what the date is, but I think it is it's great to have all these options, as you just mentioned, like it was a dark age for a while. It was not an offer, and now we have lots of options.

Yes. I think in many ways, it's actually a blessing, right? I mean I think getting ZUSDURI approved as the only chemoablative agent, and the next one in line, it's going to be a while before you get a competitor in this disease space. May actually be good for the urologic community, right? I mean you want to get urologists used to consider the idea of chemoablative, right? I mean -- and I think once we get used to it and once we get comfortable, I think you're going to see the market shift a little bit where I think some of these pharmaceutical companies may say like, look, urologists are actually now becoming comfortable giving these drugs in lieu of TURBT. And that may change their research portfolios and where they go. So I mean, I think it's dynamic, it's fluid and it's moving and the fact that you've got your first to market, and it's going to be years before somebody comes in and competes in this disease space is probably going to be good for the urologic community.

Yes, I'd like to -- I always say that we get asked a lot about it, but I think it's great for patients. I've been in oncology for 30 years. Was in oncology back when 5-year survival of cancer was very low. So I think it's great. Like you said, I think it's great to have multiple therapies. I do think that we have a benefit we've talked a lot about today and most patient-friendly, and we'll see what the data looks like, but I also find it hard to believe anybody is going to be better than we are.

And to your point, Dr. Chamie, we've got a 2-year, 3-year head start. So I think we're very excited about that, which kind of shifts to your third question, Ram, and I'm going to ask Mark to comment on sort of our pipeline, what we sort of see ourselves in urothelial cancers and that could add anything.

Yes. Thanks, Liz. So Ram, thanks for the question. I think the audience may know that we are currently finalizing a trial that will bring 103, which is the successor molecule to ZUSDURI into the high-grade space. So that trial will start this year. And we're very excited about bringing this in as an adjuvant therapy for high-grade disease. We see that as a real unmet medical need.

And then, of course, we have our oncolytic virus that is in the final stages of IND-enabling studies. And we are planning on starting a Phase I dose escalation for that, and we think that is going to be yet another opportunity to show not only that we have a pipeline of very impressive drugs to bring to the high-grade space. But we are exploring bringing that to the market in our gel as well, making -- taking advantage of that platform because there may be some additional significant advantages to patients delivering the oncolytic virus in the RTGel. So in the very short term, we are going to make some big steps forward in bringing our high-grade program forward and then I would defer to Liz, actually, with regard to where she sees UroGen going as a one-stop shop.

Well, no, I think, Ram, we do have aspirations to see whether our medicines can work across the continuum of urothelial cancers. And to Dr. Linehan's point earlier about even newly diagnosed IR patients there as well. And we have some data from our ATLAS study in that space. We believe that it would work in that space. And so we will, as Mark said, not only move forward in the high-grade space, but try to see all of the different patient populations, it's a highly segmented disease. So where do we fit in and where might we fit in.

So we're here to stay in urothelial cancers. We want to be a leader in this space and expect to see more coming in the future. So thank you for the question. So next question?

Our next question is from Amin Makarem with Jefferies.

Very informative session. I have a couple of questions. One, first, I have a question on potential UGN-103 use in adjuvant setting that you just mentioned. My question is, are there any potential benefits of using ZUSDURI in adjuvant setting versus chemoablative, meaning which patients are most likely to benefit using ZUSDURI in the adjuvant setting versus using it as chemoablative? And my second question is with few more drugs are being developed in the intermediate risk NMIBC, especially in the adjuvant, I think, how should we benchmark them versus ZUSDURI? If we think about the efficacy parameters, when we see their data that is like simply better or worse ZUSDURI or just because it's an adjuvant setting, it's different game basically?

Yes. Dr. Linehan, I don't know if you want to comment first on ZUSDURI in adjuvant setting. Would that be something that's that you think might benefit and then any other comments?

I mean I do have a subset of patients that can be symptomatic from the tumors that they have in their bladder that sometimes could be bleeding, that's one to be stone, sometimes infections. And so we have to treat those first and then you can give it adjuvant. But I think the adjuvant portion of that is that the durability is so good that that's what you're offering them that just the TURBT cannot. So you may not have a recurrence in 3 years. It's a 65% chance of that, that's TURBT is not going to give you that. And so that's where it plays the role in the adjuvant space.

Okay. Great. And any thoughts on -- as others pan out. I know we've talked a little bit about it, but as other adjuvants get enter into the market, any comments on...

I think for me, that's going to be very patient dependent like the benefit of the history is that they don't have to stay in the office. You don't have to hold it for 90 minutes. It goes in, they actually empty the bladder. They pee out the medication in 4 to 6 hours, and that convenience of it play to probably the biggest role in helping me decide which agent is next.

Okay. Great. Thank you Other comments about the -- we talked a little bit about it already, but...

Yes. I think it's going to be complex because I think with ZUSDURI, you know what it is, right? It's a chemoablative agent. It gives you 78% complete response, and you got a durability of 65% of those patients are still disease-free at 3 years. Becomes a little complicated when you're talking about adjuvant therapies, right? If you're talking about these other therapies, what's doing the work? Is it the surgery that did the work? Is it the adjuvant agent that you put in the bladder? And how do you compare this apple to this orange.

And I think comparisons going to be a little bit complex as far as seeing which drugs may be more efficacious because the comparisons aren't similar. And so I think I mean that's probably maybe worthy of a future study, but I think, obviously, for UroGen, I mean the data is kind of clean. You know what you got as far as complete response, you know what the durability is. There's no surgical component to it, right? Nobody had a TURBT amongst the patients that had a complete response, and you know what it's like. So it's going to be tough comparing them to patients who are getting in an adjuvant setting.

I mean, I don't have a whole lot of else to add up, but then in the high-grade data, we're always looking at cystectomy-free rates this is like where we should be talking about, TURBT free rates or something similar as a caveat. So I think having the option of ablative. I mean, certainly adjuvant is important. But I think the benefit here is to be able to do chemoablative. And I think that's something that we need to kind of get used to doing, as you mentioned earlier, like it's not -- normally, you see tumor resect tumor kind of reflex. So as people get more comfortable with that and they see these impressive results, I think the need for that adjuvant therapy may decrease because there's -- we're not going to have as many recurrences in as many surgeries, hopefully.

Our next question will come from Kelsey Goodwin with Piper Sandler.

Thanks for hosting this. Super helpful. I really appreciated the patient story as well. Maybe building on her journey, I guess, given ZUSDURI approved in the recurrent setting for the KOLs. You should have kind of firsthand experience within each individual patient, how they're responding to TURBT and for how long, and then same how they respond to ZUSDURI for how long. I guess -- maybe could you comment on that and what you're seeing, how it differs within any given patient?

Great. Thank you, Kelsey. And good to see you yesterday here at the AUA. I don't know if anyone want to comment?

I mean, I think we've a couple of our patients that we've gotten started. I mean, we're probably on their fifth or sixth -- 5 or 6 previous TURBT. So I think that as far as -- the one patient had that tiny little thing we zapped, but that's -- I'd say that's still a big win, not to have to go back to the OR and general anesthesia and catheters and all that stuff.

So I think as we move forward, and I'll get more experienced, hopefully, we don't have to put patients through 5 or 6 surgeries. I mean we're just doing that now just from the time frame we're in, in patients I've already -- like our patient here has already had multiple surgeries. But hopefully, moving forward, you have surgery once, you have your pathology, first recurrence, like this -- I think this is where we should be headed.

I think Mark and I have talked about this before that maybe the worst thing you can do to a tumor is resected, right? I mean you're chopping it up and then you're resecting the base of it where you leave this nice fertile layer for a tumor to reimplant. And so in many ways, maybe the TURBT is the most -- the worst thing we can do to a tumor as far as recurrence. I mean, obviously, you give chemotherapy at the time of the TURBT, but we know the uptake of doing perioperative chemotherapy at the time the TURBT is low. But still, I mean, maybe this is going to fix that issue of maybe minimizing recurrences because we're not resecting tumors and leaving a fertile ground for this tumor to regrow and reimplant.

Dr. Linehan, anything to add?

Yes. I mean, I think this product will also -- you were saying before, Karim, is teach us about this space because we actually don't know a lot about this space. We know that they recur, we know they're low grade, and we know we do TURBTs. And that's it. Now that the ZUSDURI is here, we're going to learn a lot more about, I think, the natural physiology of it.

Our next question will come from Paul Choi with Goldman Sachs.

Liz. Good morning, everyone, and thank you for sharing that patient experience. It's nice to see the journey result in a good outcome. And thanks to the doctors for joining us. My question is on use of gel-based mitomycin in high-grade disease. I know there's development plans for 103 potentially in this population. But I'm just curious from the doctor's perspective, thoughts on using a gel-based mitomycin for this high-grade population? Would you go ahead, potentially use it here now with JELMYTO available here? And just -- sorry, ZUSDURI available here and just sort of what you think about as criteria for use of the ZUSDURI here in this population?

Yes, great question. Anybody want to start there around high grade, your thoughts about ZUSDURI and high grade.

I'm very excited about ZUSDURI and high-grade patients. And I keep going back to this, but one of the reasons is a lot of my patients cannot hold the BCG. They can't hold the gem side, I mean they can't hold all the other drugs, and that's one option. And if you actually looked at the NCCN guidelines, mitomycin was one of the original drugs that we use to treat high-grade bladder cancer. And it worked very well. It didn't have the durability that the BCG did, but I think if you already have patients that have failed BCG or they can't even hold the BCG. This is where I think ZUSDURI is going to play a big role.

I mean I've had to use it off-label for patients with upper tract urothelial carcinoma. So I've had patients who've had a solitary kidney, and they've got high-grade upper tract disease, and I've had to use it. And I've got a few patients where you give them a little bit of systemic therapy. And then I put JELMYTO. And I've got, I think, 5 patients with solitary kidneys that will be facing dialysis, if I did, I took it out. And fortunately, every single one has had a complete response.

So I do think that there is activity there. And I think, obviously, for the upper tract, the complete response rate is like 59%. I think for the bladder is 78%. So I expect that the bladder would work similarly well for high-grade disease, just like I've seen it in the upper tract. But more -- we can't wait to see what the clinical trial looks like and happy to participate.

Yes. I would just echo what you were saying earlier, I think, I mean, all the new options we have, which have very strong data, but patients have to be able to hold them in there. So whether it's a children [indiscernible] imaging at some point, like you have to keep that dwell time there. And a lot of these patients, their bladders are so beat up after BCG. They just can't do it. So I think this is a great option to keep the drug where it needs to be for a prolonged time, and I'm excited to see where it goes.

We'll take our last question from Kevin DeGeeter with Ladenburg Thalmann.

Great. I want to just thank everyone for this discussion. It's incredibly helpful for me. I particularly appreciate the conversation with regard to how to think about reexposing patients after recurrence and really clear commentary for the patient that has the great durable response out 3 years or more to recurrence.

But how do you talk to your patient who has a good response, maybe 15 months, maybe closer to 12 months and has recurrence and -- after being treated on ZUSDURI? I mean, just how do you think about the patients who have done well, but not as well as we might hope. Is that sort of the same discussion at recurrence? Or help me walk through some of the nuance you might bring to that discussion.

I think that's a great question. I guess the short answer is it remains to be seen. I mean I don't think -- I certainly don't have enough experience yet with this to see those patients that are 12 months, 18 months and now have more tumor and we haven't had those conversations yet about should we try this again. I mean I think if they tolerated it well, and they had a pretty good response upfront. I don't see why there would be a reason to shift gears completely and say, let's just go back to surgery. Like, I mean that's -- it's like, okay, here's a great new option. Let's go back to the old option, which didn't work in the first place. So I think those are conversations that I will definitely be having. I just haven't had them yet, but I'm sure it'll...

We're looking forward to gathering some data around that in the -- good news is it won't be for a while, hopefully.

I mean a lot of the other new products out there that didn't have reinduction in their trials. Now there's real-world evidence coming out kind of showing improved results in the real world with reinduction. So doing repeat again another 6 courses down the road. If it's 1 year, 1.5 years, whatever, I think we'll probably see that in real-world data down the line.

Absolutely. Dr. Linehan, Dr. Chamie, any other comments?

I agree with all, everything that you said. I would do another induction of course, if they came back in 1.5 years and had more cancer.

Yes, I agree. I think the difference is, is that I wouldn't call that a recurring tumor, I'd probably call that a new tumor, right? Because I think once you go 1 year, 1.5 years out, and they've been disease-free for that period of time, that tells you that that's probably a new tumor that developed there. And so I absolutely would retreat them with.

It's good to know. Like Dr. Linehan said, we still have a lot to learn in this disease, in this space, but hopefully, we'll be learning that as we go forward.

Well, thank you, everybody. Thanks for participating today. I want to thank our panel and importantly, our patient, Cynthia, for being here, and we appreciate your time and support. So have a great day, everybody.

Thanks for joining the session with UroGen Pharma. My name is Alec Stranahan. I cover SMID Biotech here at Bank of America, and I have the pleasure of introducing Liz Barrett, the President and CEO of UroGen. Thanks for being here, Liz.

Thanks for having us.

Yes. Looking forward to the discussion. Maybe since it's a shorter 15-minute one, we can just jump right in. So you reported 1Q ZUSDURI revenue of about $30 million. That's more than 100% quarter-over-quarter growth. Obviously, still early days in the launch, but maybe you can just walk us through how that launch has been tracking versus your internal metrics.

No. Look, we're very excited about the results from Q1, but more excited about even more patients having access to the drug going forward. We talked often about the J-code, and I think some of us, including myself, wasn't expecting it to be as hard as it was prior to getting the permanent J-code. But practices are really concerned about reimbursement. So we absolutely saw the inflection as soon as we got that J-code. So we started seeing it in January. By February, we had already surpassed JELMYTO in doses, and then we just continued to go from there. So really pleased with where we are, looking at sort of our top 250 accounts, looking at penetration where we are.

But importantly, what we're really seeing is some doctors who adopt this for most of their patients. And that's, I think, something that we will look forward to, but they really buy into the new approach of treating these patients differently. And we are seeing them treat patients across the continuum of care. And so it's a very exciting time for us, as you can imagine. And we expect to continue to see linear growth quarter-over-quarter for the rest of 2026 and into 2027. So again, very exciting time.

Great. And I imagine that the early repeat adoption is only a positive speaking to the profile for ZUSDURI.

Yes, absolutely. A lot of physicians will say, I'm going to try it on one patient, going to see how it goes, make sure I get reimbursed. And when you see the repeat prescriber, you know that not only did they have a good experience, but the patient had a positive experience as well. And we're hearing, of course, a lot of it anecdotal feedback, but hearing a lot of physicians, even surprised sometimes at getting a CR in some very, very difficult to treat patients.

Okay. And you mentioned the J-code as being kind of a -- maybe watershed is not the right term, but it's definitely -- it unlocks a door for the rollout. Do you see this as benefiting the academic setting or the community setting? I think you said that you're approaching maybe a 50-50 hospital to community mix now, which is up from 60-40, I think, in 4Q. So how does the community adoption ramp? I know that this is maybe 70% or so for the market?

Yes, absolutely. I mean most patients, particularly with the low-grade non-muscle invasive bladder cancer are seen in the community. So getting to the community practice, getting the community practice to adopt is very important. Those were the physicians that were very gun-shy with the J-code. The academic centers, you have the P&T Committee you have to go through. So there were some barriers there. But as far as they don't look at it from a financial standpoint as much as community practices do because if they just don't get reimbursed for one patient, it's a big deal. So now that we have reimbursement, but more importantly, that it fits into the way that they practice.

So having intravesical therapy, they're used to intravesical therapy. They do it in other ways. And so it really fits into their practice. It fits into the way that they treat patients and it's economically beneficial for them. So once they get again over that hump, you'll start to see more and more community. So we expect -- I don't think even though 70% of patients are seen there, I expect that they -- ultimately, 65% of the revenue will come from the community practices.

Right. From a patient convenience perspective, you want to treat them where they are.

Sure. Absolutely. And look, the doctor also doesn't want to lose the patient. So they don't want to send them to the hospital. They want to keep that patient and the way they do that is by treating them in their office.

That makes sense. I guess when you think about the total addressable market, I think there's some publications out there that estimate maybe 85,000 annual patients roughly in this setting. You mentioned the physician feedback and getting CRs in patients that even the treating physician didn't think that they'd be able to get to that point. So do you sort of see this addressable market expanding? Or is that more of like a percentage applicable within that?

I think it's more of a percentage applicable because, again, like what typically happens in oncology drugs, you always use the new drug in your hardest patient first. And -- because they unfortunately have gone through a lot of other treatments and haven't had much success. And so that's, I think, why we're seeing some of these, but it's very, for me, heartwarming to hear about these patients, again, that have had such a difficult time for many, many years.

And then they come, they do 6 weekly doses. They can get up and go home after. There's no real barrier to them going about their daily life and then they come back and they've gotten a complete response. So both from a patient perspective and a physician perspective, that's what has to happen for a doctor to further adopt it. And then they'll move it up in the continuum. In our study, most of the patients had only had 1 or 2 recurrences. So we expect that as the drug gets adopted more broadly, you'll move up in the continuum of care.

Okay. And we've talked about kind of the demand components from the patient and then the prescriber. How has payer access and reimbursement sort of trended?

The good news is we have 95% open access for reimbursement. Knock on wood, we haven't had any denials yet. So we're really, really pleased that everyone has been able to get reimbursed. Some payers take longer than others, sometimes the paperworks. But once you get all of that -- through all of that, we've had very positive reimbursement. And so again, as physicians start to see that, the practices start to see that, we have a team that works with practices if there are issues to ensure we have field reimbursement managers. We have a hub to ensure that they get all of the service that they need to help them, again, remove any barrier that they might have for -- to be able to use this in patients. And we are starting to also hear about patients walking in and asking the doctor for the drug. And we've just started to do more engagement with patients, believing that will be a big driver for us going forward.

Okay. That's great. And I imagine when you set the price, you had already approached in terms of cost benefit with all these...

Absolutely. No, absolutely. And our price, particularly when you compare it to the high grade, we are -- our drug is for the low-grade patients. So we price appropriately for that market as we have the low-grade IR. So we feel really good about our pricing. We feel really good about reimbursement. And so really, it's just a matter of physicians trying it and getting a positive experience.

Okay. And whenever we think about new oncology launches, we think about the on rate, but also the duration on therapy. This morning, I think you had a press release talking about 36-month follow-up from the ENVISION trial. I think it was 64.5% of patients had a 36-month duration of response. Maybe you could just speak to how this evolving data set is favorable in your view and how this kind of feeds into your communication with prescribers?

Well, we were thrilled to be able to share that data. What it says, and we have to keep in mind that the low-grade intermediate risk patient is all about recurrence. These patients recur. In our own ATLAS study, the median time to recurrence in the TURBT alone arm was 9 months. So we now are past 36 months, and we still haven't reached the median. So with 6 weekly doses of ZUSDURI, we believe that the median will be close to where we are with JELMYTO, which is about 4 years. So if you think about it, again, from a patient perspective, you have -- that's why we often talk about not only recurrence-free but treatment-free living because they can do the 6 doses, and again, the median hasn't been reached and it's been over 36 months. So we just recently got that data. I'm very, very thrilled to see the durability of response because that's really important for patients and patient care.

Yes. Yes, I imagine so. And this weekend is AUA.

Yes.

I imagine you guys are going to fly out to D.C. right after this.

We are.

Are you planning to host any panels? And I guess, how are you trying to use the conference to increase awareness? Obviously, there's already great awareness of ZUSDURI, but anything that we should expect coming up at AUA?

Yes. Look, it's a great opportunity to have a lot of key stakeholders in one place at one time. It's a busy, busy time. We have not only -- we're doing ad boards across our portfolio, but we are hosting an event on Sunday morning, specifically around ZUSDURI and Dr. Schoenberg, our Chief Medical Officer, will interview physicians who have used it. And we also were really thrilled that we're also going to have a patient who's flying out from California, and we'll be able to talk to her as well. And that will be webcast. So we're excited about that. Dr. Schoenberg will also present on Monday morning our 24-month data, which is kind of interesting because now we have 36 months, so he'll be able to put a plug in for our 36-month data.

But we importantly want to spend the time making sure that any physician who has questions are those that are thinking about ZUSDURI, are JELMYTO, but maybe aren't quite over the hump. It's a good opportunity for people like myself and Mark and Mike, our Chief Development Officer, to be able to engage one-on-one with these doctors. And I myself have a lot of meetings over the next -- over the 3 days, but we're really trying to get to ensuring that we understand if there are any barriers to using our medicines, what are they and what can we do to overcome them because we want to make sure that every patient that can benefit from our medicines has the opportunity to benefit.

Great. Yes, we'll definitely be tuning into the webcast. I do want to ask about your -- the pipeline. I'm sure you get a lot of focus on ZUSDURI, but I think we should shine a light on -- you've got 103, which is your next-generation mitomycin formulation, streamlined reconstitution process, patents out into the 2040s. Maybe you can just speak at a high level to what you're seeing in the Phase III UTOPIA trial.

Yes. What we're seeing in the UTOPIA trial is very consistent data to what we see in ZUSDURI. And that's what's most important, right? When we worked with the FDA, initially, they said we couldn't do a bridging study. You actually have to do a patient study because the drug is a different drug. And luckily, what we've seen so far has been very consistent, and that's what we want to see. The other good news about having the patent extended is we have a lot of aspirations for moving UGN-103 into other patient populations with bladder cancer. So we are going to -- we're moving very quickly into high grade. We're also going to do an adjuvant study. And so we're looking at being able to cover patients, again, not just in the IR space that we have today, but also in other spaces as well.

And then 104, UGN-104 for UTUC, upper tract, same thing. We expect to finish enrollment this year. And the thing I think what we're most excited about is our oncolytic virus. It's early, and we actually are going to first-in-human this year. But we really believe based on the preclinical data and the experiments that we've been doing that we have a truly differentiated and potentially best-in-class molecule. And so that's exciting for us because not just will it be best-in-class in bladder cancer, but it gives our company the opportunity to actually move outside of bladder cancer and outside of urothelial cancers because that oncolytic virus can work across many cancers.

Okay. Very good. Maybe talking about the expansion opportunity beyond low grade for 103. I guess, how are you thinking about moving up the spectrum and adding different sleeves of patients within NMIBC?

Yes. I think, obviously, there's a lot. It's a fairly crowded market, but unfortunately, these patients aren't cured. And every -- there's no drug that's perfect, right? So we actually believe that given the results that we've seen in the low-grade intermediate risk patient that we believe it will also work very well in the high-grade patient. Now the difference is it will be an adjuvant. The difference it will be maintenance therapy because these patients are at a higher risk for mortality, they're at a higher risk for moving to metastatic disease. So we would treat those patients longer.

But we definitely believe and we have seen so far that it works in -- with bladder cancer, and we expect it to work across the spectrum. So we're finalizing right now exactly what the patient population will look like and what our control will look like because it will be a comparative study. But we could go into BCG-naive and the BCG-unresponsive, those -- so a lot of different spaces to go into there and still a very high unmet need despite the fact that others are in that space.

Okay. And I guess you have some experience from the ATLAS study. Is that right?

Well, the ATLAS study was also in low-grade IR as well. So that was -- it was in that study as well.

Okay. So at least comparing against...

Exactly. The TURBT. Yes, absolutely.

Okay. Maybe we can talk about 501, too. How is this maybe symbolic of how you imagine the company growing beyond sort of your current...

Well, I think that everyone -- UroGen has been around and we've had JELMYTO and we've had ZUSDURI, right? And that's been kind of the focus externally and internally for a long time. But we have aspirations to be a leader in urothelial and specialty cancers. And we believe 501 gives us that opportunity. Again, it's an oncolytic virus that's differentiated. It not only works in the immune system, but it has direct cancer kill. We believe we actually can put it in our gel and maybe even see better efficacy and that we know based off of the work that IconOVir did before we acquired it, that it works in other cancers as well. So that's why we believe that 501 is a catalyst that will bring our company from just being a leader in urothelial cancers to expanding beyond and diversifying outside of urothelial cancers.

Okay. Very good. Lots of exciting things going on at UroGen. But unfortunately, we'll have to leave it there. So please join me in thanking Liz for the great conversation.

Thank you, Alec. Appreciate it.

Good day, and thank you for standing by. Welcome to the UroGen Pharma Q1 2026 Results Earnings Call. [Operator Instructions] Please be advised that today's conference call is being recorded.

I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of IR.

Thank you. Good morning, everyone, and welcome to UroGen Pharma's First Quarter 2026 Financial Results and Business Update Conference Call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31, 2026. The release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Chris Degnan, Chief Financial Officer.

On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, our ongoing and planned clinical trials and nonclinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations as well as anticipated data, regulatory filings and decisions, the importance of ZUSDURI's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals and 2026 financial guidance, among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements.

I'll now turn the call over to Liz.

Thanks, Vincent. Good morning, and thank you for joining us today. Before I provide our business update, I wanted to share that given the critical importance of a successful ZUSDURI launch, the Board and I made the decision a few months ago that I would assume direct oversight of the commercial organization, resulting in the departure of David Lynn. For the past several months, I have engaged directly with our commercial team and key external stakeholders, and this change has enhanced our ability to remain agile, promote efficient decision-making and leverage the expertise of our executive team.

Now turning to our results. We are very pleased by our performance in the first quarter, highlighted by $29.2 million in ZUSDURI revenue. This represents more than 100% quarter-over-quarter growth. As expected, the implementation of the permanent J-code in January marked a major inflection point, and we are now seeing clear acceleration across key commercial metrics. The early momentum we discussed in the initial phase of the launch is now translating into expanded utilization and meaningful growth.

Overall, the trends we are seeing are in line with our expectations and provide early validation of our commercial model. This progress reflects the differentiated value ZUSDURI brings to patients and physicians. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, ZUSDURI offers a nonsurgical treatment in a disease historically managed through repeated surgical intervention. ZUSDURI's profile as a primary chemoablative therapy represent a fundamentally different approach to treating these patients. Importantly, our clinical data has demonstrated unprecedented complete response and durability of response, offering patients meaningful recurrence-free periods and treatment-free living.

Let me provide more detail on the metrics we are tracking. We continue to see strong growth in both unique and repeat prescribers. By the end of the first quarter, we had 256 unique prescribers, up from 102 at year-end. and 103 repeat prescribers, up from 32. This is the most important indicators we track as it reflects growing HCP confidence and successful integration of ZUSDURI into routine urology practice. Importantly, these growth trends were consistent throughout the quarter and not limited to the immediate period following the implementation of the J-code.

This gives us confidence in the durability of the launch and supports our expectation for continued growth as we move through Q2 and the rest of the year. Patient enrollment forms, or PEFs, remain an important early indicator of demand, providing visibility into activity at the top of the funnel before it is reflected in new patient starts and revenue. In Q1, we saw continued sequential growth in PEF volume, which we believe reflects strong and expanded health care provider engagement. As we've shared, PEFs, new patient starts and doses all significantly outpaced JELMYTO in Q1, and we expect continued growth across all measures over the course of the year.

In terms of conversion, the cycle time from PEF to treatment initiation was approximately 45 to 60 days in Q4, which was expected as sites work through onboarding and workflow integration. In Q1, we continue to see improvement and expect this to continue over the course of the year, moving toward the 2- to 3-week range we see today with JELMYTO. We also see a continued shift toward greater utilization in community practices. In Q4, the mix was approximately 60% hospital and 40% community, and we are now approaching a more balanced mix, closer to 50-50 at quarter end. Given that approximately 70% of the overall market opportunity resides in the community setting, we expect this shift towards community practices will continue and will be an important driver of long-term growth for ZUSDURI.

From an access and reimbursement perspective, we have open access across more than 95% of covered lives and reimbursement confidence has significantly improved amongst practices with a permanent J-code for ZUSDURI becoming effective on January 1, 2026. The J-code has been a key catalyst for broader utilization in 2026, especially in the community setting. Looking ahead, we expect continued strong growth throughout 2026. Our focus remains on expanding adoption in the community setting, driving depth of utilization in accounts who have used ZUSDURI and continue to improve patient conversion time lines.

In parallel, we are beginning to expand our commercial approach to more directly engage patients, including targeted awareness efforts as we believe patients can be a key catalyst to drive adoption and ZUSDURI is in a unique position of providing both recurrence and treatment-free living. ZUSDURI addresses an estimated $5 billion annual market opportunity in recurrent low-grade intermediate risk non-muscle invasive bladder cancer, and we believe its differentiated clinical profile positions it to capture a meaningful share of that market. As adoption continues to build, we see ZUSDURI as a foundational treatment for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer patients with the potential to evolve into a blockbuster therapy with peak annual revenues exceeding $1 billion.

Turning to JELMYTO. We reported revenue of $21.7 million in the first quarter and continue to see a stable, predictable demand profile. We are also continuing to add new users, reflecting sustained confidence among urologists and remain on track to achieve our 2026 sales guidance of $97 million to $101 million. We continue to advance our pipeline, including UGN-103, our next-generation mitomycin-based intravescal therapy, where we will have established a clear regulatory pathway for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer.

We remain on track for our NDA submission in the second half of 2026. with potential approval in 2027. We also plan to expand this product into additional bladder cancer settings as part of our broader life cycle strategy. More broadly, as leaders in uro-oncology, we believe that non-muscle invasive bladder cancer patients need options, and we are committed to developing multiple modalities to address the significant unmet need in this space. Mark will provide more detail on our pipeline in a few moments.

Finally, we have a strong balance sheet with approximately $140 million in cash, cash equivalents and marketable securities as of March 31, supported by the refinancing of our term loan with Pharmakon Advisors during the quarter. This provides us with the flexibility to fully support the ongoing launch of ZUSDURI while continuing to invest in our next-generation pipeline with cash runway to and through profitability. Overall, we believe we are well positioned to execute on our strategy, build on our current momentum and deliver meaningful outcomes for our patients while generating long-term shareholder value.

I will now turn the call over to Mark for a clinical update. Mark?

Thank you, Liz. The American Urologic Association Annual Meeting will take place May 15 to 18 in Washington, D.C. UroGen will have a significant presence there, and we believe this is an important opportunity to engage with both community and academic urologists and further discuss the clinical value of ZUSDURI and JELMYTO. For UroGen, the national AUA meeting represents a highly relevant and meaningful forum to continue building awareness and health care provider engagement. Bladder cancer will be a central focus of this year's meeting, and it's important to clearly define where ZUSDURI fits within the evolving treatment landscape for NMIBC.

In intermediate risk disease, the primary clinical challenge is the management of recurrence rather than progression. Patients commonly experience multiple recurrences, requiring repeated TURBT procedures under general anesthesia over time, which contributes to a significant cumulative treatment burden. Accordingly, both patients and physicians are focused on strategies that reduce the frequency of interventions and enable a more rapid return to normal daily activities.

ZUSDURI was specifically designed to address this need. Its clinical benefit is driven by both its efficacy and mode of administration. In the Phase II ENVISION trial, which supported its FDA approval, ZUSDURI demonstrated a robust complete response rate of approximately 80% at 3 months and importantly, durable outcomes over time. At 24 months, the probability of remaining event-free following complete response was approximately 72% based on Kaplan-Meier analysis. These data were recently published in the Journal of Urology and will be featured in a podium presentation at the upcoming AUA Congress. Importantly, median duration of response has not been reached in the ENVISION study at a median follow-up of 23.7 months after 3-month complete response.

From a clinical perspective, this level of durability is meaningful as it has the potential to interrupt the cycle of recurrences and decreases patients' treatment burden. In practical terms, it translates into longer recurrence-free intervals and extended periods without treatment. Equally important is how ZUSDURI is delivered. It is administered as a finite 6-dose chemoablative regimen in the outpatient setting without the need for surgery or ongoing maintenance therapy.

In our experience, this allows for straightforward integration into routine clinical practice without significant changes to workflow or infrastructure. This approach is distinct from many therapies currently in development, which are typically evaluated in the adjuvant setting and administered following TURBT. These regimens often involve induction and maintenance therapy over extended periods, in some cases, up to 1 year. ZUSDURI by contrast is designed as a primary nonsurgical therapy with a total treatment duration of 6 weeks.

Taken together, this approach represents a meaningful shift in how this disease can be managed, offering durable disease control for the finite course of therapy while reducing treatment burden and enabling extended recurrence-free and treatment-free living. As we continue to gain real-world experience, understanding how these clinical benefits translate into routine practice is increasingly important.

At the upcoming AUA Annual Meeting, UroGen will host the KOL panel focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns and patient outcomes. This event will be webcast and accessible through the company's website, and we believe it will provide important clinical perspective on how ZUSDURI is being incorporated into routine practice.

Turning now to the pipeline. UGN-103 is our next-generation mitomycin-based formulation for recurrent low-grade intermediate risk non-muscle invasive bladder cancer, developed to build on the foundation established by ZUSDURI. It is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure while also having intellectual property coverage into December of 2041. We plan to submit an NDA for UGN-103 in the second half of this year based on results from the Phase III ZoTtoPIia trial, which demonstrated a 77.8% complete response rate at 3 months, consistent with what we observed with ZUSDURI.

We are aligned with the FDA that the NDA can be submitted with 6-month durability data with plans to update the filing as 12-month durability data become available. 6-month durability data are expected midyear. And if we receive FDA approval in 2027, we expect the permanent J-code could become effective as early as the beginning of 2028. We also see significant opportunity to expand UGN-103 beyond its initial planned indication. We are actively pursuing development in high-grade NMIBC as well as in the adjuvant setting for intermediate risk disease, both of which represent meaningful opportunities to broaden the impact of this program.

We plan to hold Type C meetings with the FDA in the second quarter of 2026 to align on the development plans for both studies with the goal of initiating a Phase III trial in high-grade disease before year-end and in the adjuvant intermediate risk setting thereafter. UGN-104, our next-generation program for low-grade upper tract urothelial cancer continues to progress in a Phase III trial as planned with enrollment expected to complete by the end of 2026.

Finally, UGN-501 is our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer. UGN-501 was specifically designed and genetically engineered to act like chemotherapy initially, producing widespread tumor cell lysis with a subsequent immunomodulatory benefit, which we believe differentiates UGN-501 from other oncolytic viruses in development. IND-enabling studies are nearing completion, and we plan to submit an IND in the second quarter of 2026 and initiate a Phase I clinical trial in NMIBC by year-end.

Our nonclinical data support the potential for UGN-501 to be a differentiated oncolytic virus, demonstrating broad and consistent cytotoxic activity across a large panel of bladder cancer cell lines representing a range of tumor stages and grades. These findings reinforce our belief that UGN-501 has the potential to be best-in-class, highly active, locally delivered therapeutic approach in this setting.

The Phase I trial will initially evaluate UGN-501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery, including administration with our proprietary RTGel technology, which may enable prolonged dwell time and enhance local activity. While our initial focus is bladder cancer, we believe this platform has the potential to extend beyond the genitourinary setting into additional tumor types over time.

I will now hand it over to Chris to discuss our financial results.

Thank you, Mark. Q1 represents an important step forward as we begin to see the early commercial momentum of ZUSDURI translate into meaningful revenue growth while continuing to manage our cost structure in a disciplined manner. At the same time, we remain focused on supporting the ongoing launch of ZUSDURI, advancing our pipeline and maintain the financial flexibility needed to execute on our long-term strategy.

Now to our financial results. Total revenue was $51 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. The 152% year-over-year increase was primarily driven by the commercial launch of ZUSDURI and JELMYTO revenue growth also contributed to the increase. Research and development expenses were $15.6 million in the first quarter of 2026 compared with $19.9 million in the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which we recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval.

Selling, general and administrative expenses were $51.5 million in the first quarter of 2026 compared with $35 million in the first quarter of 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, an increase in overall commercial operation costs and higher advisory costs, including fees associated with the Pharmakon debt refinancing. We expect Q1 to be the high point of SG&A expense in the year based on phasing of activities and the onetime costs associated with the debt refinancing in the period.

Financing expense related to the prepaid forward obligation to RTW Investments was $4.5 million for the first quarter of 2026 compared with $4.6 million in the prior year. Interest expense related to long-term debt was $4.2 million in the first quarter of 2026 compared to $4.1 million in the same period in 2025. The slight increase in interest expense was primarily attributable to the additional borrowings of $75 million in the first quarter of 2026 in connection with the Pharmakon debt refinancing, offset by the lower interest rate.

The company reported a net loss of $23.6 million or $0.47 per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million or $0.92 per basic and diluted share in the first quarter of 2025. As of March 31, 2026, cash, cash equivalents and marketable securities totaled $140.3 million.

Finally, turning to guidance. The guidance that we provided on the year-end call in March is unchanged. For the full year 2026, net product revenues for JELMYTO are expected to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over 2025. We are not providing formal sales guidance for ZUSDURI in 2026 at this time, given that the product is still in the early stages of its launch. Full year 2026 operating expenses are expected to be in the range of $240 million to $250 million, including noncash share-based compensation expense of $20 million to $24 million.

That concludes our prepared remarks. We will now open the call to questions.

[Operator Instructions] Our first question comes from Tara Bancroft from TD Cowen.

So congrats on the great quarter. I love to see it. And with this quarter, it appears that you'll pretty significantly exceed the ANctiva's demand-driven growth that you previously pointed to as a solid analog for the 6 months post the permanent J-code. So I'm wondering if you have any updated thoughts on how we should think about growth for the rest of the year from here? And maybe is there any other analog that we should look to instead from here?

Tara, thank you. I'm going to ask Chris to comment, and then I'll add any other commentary.

Yes, Tara, thanks for the question. To your point, I mean, we pointed to Activa, just to rebro folks, when we looked at the first 6 months with the permanent J-code, they saw a 220% step-up in their revenue. And to your point, given the performance in Q1, we're tracking ahead of that analog. Again, we're not guiding for the year, but I mean, I think it's important to reiterate a few points from the call. One that we're seeing consistent growth across all our commercial indicators.

This wasn't a onetime step-up with the J-code that we saw in January. So these trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that the underlying demand is building in a sustainable way. And as Liz mentioned on the call, we do expect continued growth in Q2 and throughout the year given the early stages of the launch.

Yes. Unfortunately, Karen, I don't -- we don't have a great analog, to be honest with you, that we could share with you. I think as Chris stated, I think we feel good about where we are. We expect to continue to grow. We do want to caution everybody that quarter-over-quarter growth is not likely to be the same as we go forward as it was in the Q1 versus Q4 because of the J-code dynamics, but we do expect to continue to see quarter-over-quarter growth.

So I wish we could give you an analog. I think we're happy with where we are. We'll continue to see growth and think we're in a good place. And -- but right now, we're just not in a good position to provide any additional guidance beyond that.

Our next question comes from Kelsey Goodwin from Piper Sandler.

Congrats on the really strong quarter. That's wonderful. Two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting ZUSDURI? What kind of patients are getting ZUSDURI now? And when patients recur? How do you get ZUSDURI to kind of be that first product that physicians reach for? And then secondly, on reimbursement. Now that the physicians are getting more comfortable post permanent J-code, I guess maybe could you provide some color on what kind of cost sensitivity you're seeing given ZUSDURI is priced relatively lower than some of the high-risk programs at about $130,000 price range?

Kelsey, great questions. One, I can give you anecdotally, but we don't track, obviously, how many TURBTs. -- that information just isn't available. What we're hearing in the beginning is most of the patients that are getting treated in the beginning are those that have had at least 2 or 3 TURBTs. Having said that, we do have physicians that have already adopted ZUSDURI as sort of their standard of care and so for a recurrent patients.

And what I mean by that is they're looking -- we do have physicians who have treated several patients into the high teens. And so they are really adopting it across the entire paradigm of patients. So I think we will get there, and we want to be very careful, and that's one of the things we also are very careful with our sales team is that we don't niche ourselves into those that have had multiple TURBTs. Keeping in mind that 23% have had 5 or more and 68% have had 2 or more. So even if we did have those patients, it's still a large number of patients, but we want to make sure that everybody understands.

And particularly if you look at our clinical study, a lot of those patients only had 1 or 2. And so we are seeing again. But initially, it's the expectation, and this happens across all of oncology, you typically start with your later line of patients and then move up after they see good results. So that's kind of where we are with that. On the cost sensitivity, it's kind of an interesting position for us to be in because obviously, the ones that you're talking about are all high grade. And so it's hard to -- but we do get lumped in, unfortunately, when they talk about a high-priced drug, they are lumping us in there.

So we have to continuously remind everybody, to your point, that our price is significantly less. And we also want to bring that awareness as those high-priced drugs start to move into the low-grade space. When we developed our pricing, it was specifically for the low-grade patients and also take into consideration the duration of therapy because one of the reasons that ours is $130,000 is because you only have 6 doses and you're done. You don't need to continue maintenance. Whereas you look at the other players in the market, both for high-grade and those coming into IR, they have maintenance therapy.

So you're talking about 6 doses versus 14-plus doses, that also increases the price. So we hope that not only that physicians, payers see the value and the value price that we have, and I think we've been very responsible from that standpoint for the patient population that we're talking about.

Our next question comes from [ Amin Makaran ] from Jefferies...

On the quarter. Two from us. First, just following up on the prior question. Can you comment on 2Q demand trends versus 1Q so far, what you're seeing on the field? And whether you're seeing any acceleration early in this quarter? And then the second one, within the new prescribers, how does the mix break down between community versus academic? And are you seeing a meaningful differences in demand across these groups already early in this launch?

Yes. Chris, do you want to comment and then I'll.

Sure. I mean, thanks for the question. So in terms of Q2, I mean, obviously, early stages of Q2, but I would say not necessarily acceleration, but just continued demand growth. As I said, we saw continued growth month-over-month through Q1. And I would say that trend continues in the early stages of Q2. And in terms of mix, as Liz mentioned on the call, 60% of our business was in the hospital setting last year, and we've already now exceeded 50% mix in the community setting in Q1. And so that is a big part of our growth, and we expect that to continue to shift more and more towards the community practices throughout the course of the year. And just a reminder, 65%, 70% of these patients are treated in the community setting. So that's a big piece with the J-code being in place and opening up those practices for us.

Yes. I think it's also just important to note that community very important, but also a lot of the academic centers who do have a lot of these patients, they also continue to come on board. So we have some large academic centers that we've just received in the last month, the formulary, positive formulary decision. So you'll see some new academic centers coming on board as well. So it's a continuous thing. But obviously, most of those patients, low-grade patients do get treated in the community as we grow community, but also important that we also support the institutions as they are big drivers also of the adoption.

Our next question comes from Michael Schmidt from Guggenheim.

Congrats on a great first quarter. Yes, maybe just another follow-up on ZUSDURI. Could you just comment if you're seeing a change perhaps in the type of patients that are choosing ZUSDURI now over TURBT. I think initially, you spoke about the preference by patients who are high risk, surgery high risk or elderly type patients. I'm just curious if that's shifting a bit now that the product has been on the market longer. And then maybe bigger picture, how do you think about the intermediate risk market evolving longer term with the potential entry of adjuvant therapies in the future postURBT? And how could that impact the landscape as you think about ZUSDURI use long term?

Yes. No, great. Michael, I love the word when you said "patients choosing. I will say that, yes, we are seeing across the board, different types of patients getting -- being able to get ZUSDURI. I think your -- in your comment about that, I will also say -- I'll also answer as part of your second question. what we are finding and what we're hearing, and this is anecdotal, right? So I just want to be very careful about that is we are starting to see and hear about patients requesting ZUSDURI.

We're hearing things like, oh, I want that gel stuff. And so patients as they're starting to hear more about that, one of the ways that we believe we can clearly differentiate ourselves versus the market as the market evolves is given that we are the treatment that does not have surgery, yet we have very meaningful clinical results. And so when you talk to patients, they don't want another surgery. So while at the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because they -- it's just -- it's in their nature to cut it out and then come back with another therapy.

I think you're going to see that patients are going to be opposed to that. And patients are going to want to say, "Hey, let me see how this one works without surgery because you can go back and have surgery. I'll give you an example. We just heard about a patient who had multiple recurrences and very close together, use ZUSDURI and she did have 2 small lesions, which were able to be full graded in the office. So I think more and more as you start to hear about that, then I think our drug will get used less in the adjuvant. It does get used. We do know the physicians that are even using ZUSDURI right now after surgery.

But again, one of the biggest benefits we can provide and why we believe we will be the patient's choice for a treatment is because not only do you not have to have surgery, but you also don't have to have maintenance therapy. So it's a clear differentiator for us. And given the results, you have to look at the complete response and the durability that we have without surgery. So to your point, I think it will continue to evolve. I think there'll be opportunity for others in the space. I think more companies and more drugs being introduced will help to grow the market. And as we've talked about before, even given our -- the pricing of our medicine and the use of only 6 weekly doses, we still believe we will have over $1 billion revenue drug with only less than a 20% market penetration.

So I think there's plenty of room for the category and for the area to evolve, but I also believe that we have a clear differentiator versus anyone coming in and especially even today, there's no one coming in, in the near future. So it's going to be a couple of years before there's others coming in. But our ability to offer patients an opportunity to not go through surgery, but still get very meaningful results is very critical.

Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co.

Just 3 quick ones from us. Firstly, I was wondering if you could give us a sense of where you expect the timing between receipt of a patient enrollment form and finalization of reimbursement for ZUSDURI to be by the end of 2026, given the impact of the J-code. Secondly, I was wondering if you could talk a little bit further about the community hospital contribution at steady state to the ZUSDURI revenue base just on a percentage basis? And also if there are any specific nuances between what you see as the receptivity at the community setting relative to the academic setting?

And then lastly, I was wondering if you could just provide us with a few words on JELMYTO and what you see as the long-term future for that product. as well as the life cycle management initiative with 104. Can we expect some reacceleration of JELMYTO uptake? Do you think that there is some incremental gain to be made on that front with that product? And perhaps most importantly, are you seeing some renewed interest in JELMYTO given the receptivity you've seen so far with ZUSDURI among prescribing physicians?

Yes. I'm going to actually go backwards, if that's okay, Ram. And then I'll leave the last question for -- which is your first question, and I'll turn it over to Chris. On JELMYTO, look, we expect, as I mentioned in the remarks, just to continue to see the sort of predictable growth where we are. So we will continue to see low single-digit growth. That's what we've been talking about. The good news is that we do see -- continue to see new users of JELMYTO. The issue for JELMYTO always comes around finding the patients.

So as we go out and talk about ZUSDURI, when even before ZUSDURI may be on formulary, they're hearing about JELMYTO, we're getting new users using JELMYTO. So every quarter, we have new physicians using JELMYTO. So we expect that to continue. And again, the challenge there is really where the patient presents. So you may have a doctor this quarter and that doctor won't see another JELMYTO patient for 2, 3, 4 quarters. And so a lot of that -- so while we expect to continue this low single-digit growth, we also do expect there to be continued new users of JELMYTO. And I think ZUSDURI will help that, and we've talked about that before.

With UGN coming in, it will be interesting to see the data with UGN-104. And the only reason I say that is because if you recall, the stricter rate for JELMYTO was high because of the way that the FDA required that we characterize that. And so we had some physicians who see that and get a little bit worried about that. But now that the nephrostomy tube is at least half of the usage and the clinical study, we'll have to see how that comes out in the clinical study. And also given the long-term durability of JELMYTO, and we're seeing very similar results with ZUSDURI. And so I think all of those things point to our ability to continue to grow the low single digits for JELMYTO.

So -- and the fact that we'll continue to grow the number of doctors that we're calling on with ZUSDURI, and that will also help JELMYTO. On the community versus the hospital, where we end up, my guess is going to be more of a 60-40 situation where most of it is coming from the community because that's just where the patients get seen. I mean that's reality. Having said that, I don't want to negate the fact that the institutions are very important. And that's -- a lot of that is because once these patients have been treated multiple times, they tend to be sent to an institution or an academic institution.

And we also know that they tend to be high-volume accounts. And so while we expect ultimately the community to be bigger, we -- the institutions will always be a major part of ZUSDURI. And we have some institution physicians who have already become real champions and advocates of ZUSDURI. -- as I mentioned before, are using it on most of their patients. And they're seeing -- and I'm sure you heard last week with Dr. Chamee, he's seeing more patients than he frankly thought he would -- that are appropriate for ZUSDURI. And I think we're hearing that more and more. So I think that's where we'll end up.

And then I'll just ask Chris to talk a little bit about the conversion timing and where we expect it to be by end of 2026. So Chris?

Thanks, Ron. So from PAF to new patient starts, as we talked about, last year was roughly 45 to 60 days. And a lot of that less so the benefit verification, which only takes a few days once it's submitted to the hub. It was more of the operational pieces and also as more use was in the hospital last year, just getting on hospital formulary, et cetera. So we do expect as this gets adopted into clinical workflows that our time to conversion is going to compress. And we did see that already in Q1. So average time to conversion in Q1 was 30 to 35 days. So we're starting to see that walk down, and we expect ultimately in steady state to be closer to where we are today for JELMYTO, which is 2 to 3 weeks from PEP to new patient start.

Our last question comes from Paul Choi from Goldman Sachs.

Let me add my congratulations on the good results. Liz, I was wondering if you can maybe provide some color on where the ZUSDURI uptake is happening. Specifically, what is the sort of percentage of overlap with existing JELMYTO users versus prescribers who are just new and outside your current commercial base or prior commercial base? And my second question for Mark is, I was wondering if you could expand a little bit more on UGN-103 development plans and potentially an adjuvant trial that seems to be the direction of travel for some of your competitors and just what that kind of trial in your mind might look like for UGN-103?

Yes. Sure, Paul. Mark, would you like to start there?

Yes, sure. Thanks, Liz. Thank you, Paul. So yes, we are excited about UGN-103's NDA submission this year and an expected approval for the successor molecule for ZUSDURI. In terms of expanding the label or the indication into other aspects of the disease spectrum, we certainly are in the process of finalizing conversations about what trials would look like as adjuvant therapy for newly diagnosed intermediate risk disease and also for high-grade high-risk disease. Both of those trial designs anticipate prospective randomized adjuvant therapy with the control arm, and we are in the process of finalizing the details of those trials, and we anticipate initiating the high-grade trial this year. That's our current plan.

Yes. I think the only additional comment I'll make about that is I still hold to what I said earlier in the IR space is that I think doing it without having to do surgery is a real benefit. Having said that, because some physicians want to, it's probably in our best interest to at least generate some data of using ZUSDURI in the adjuvant setting. So it's one of the reasons we're doing what Mark was talking about. To go to your first question around JELMYTO overlap, absolutely. And some of our initial users are JELMYTO users, and we see today over 50% of the ZUSDURI users are JELMYTO users.

That's not surprising, obviously, because the 95% of JELMYTO users are ZUSDURI or potential ZUSDURI. It doesn't -- the flip side is not necessarily the case given the rare nature of the upper tract urothelial carcinoma. But -- so we're seeing again now in the beginning, I would say it was even higher. We started out -- some of our initial users were JELMYTO users, so probably 80% but now it's a little over 50%. So we're seeing both the JELMYTO and non-JELMYTO users using ZUSDURI. So I hope that helps, Paul.

Yes, it does.

We have the last question will be from Leland Gershell from Oppenheimer.

Rific to see ZUSDURI hitting its stride here. Just Liz and team, I wanted to ask, I appreciate the additional launch metrics that you provided. It looks like you're making solid progress there on activated sites and prescribers. If you would -- wondering if you could share with us where you may be sort of in the context of your overall rollout plan with respect to goals of those various metrics.

Thanks, Leland, and thanks for the support. Very, very early. So we're nowhere near where we want to be. We have a target of 8,500 doctors, health care providers. And we're -- as we talked about today, we've only got 300 unique prescribers. So we have a long way to go. But I think that's great news, right? It's good news for us because that means the opportunity since we're already seeing the great results so far in Q1, we believe that those that have used it, we're getting very positive feedback, but we have a long way to go with new users, and we'll continue to add new users.

And part of our -- I mean, our strategy is both breadth and depth because we also do know that those physicians who have already used it have more patients that they could use it on. But absolutely, we have a long way to go. So we're just in the very, very early stages of where we want to be with penetration among docs. So a long way to go, very, very early in early stages.

I'm showing no further questions. This concludes the question-and-answer session. I would now like to turn it back to Liz Barrett for closing remarks.

Thanks. I'm sorry about that. Just wanted to say thank you to everybody who have been supportive of us for a long time. I think we're finally starting to see the results that we've always known that we could bring. I think the most important thing that we really like to focus on is the impact that we're having on patients because we really do believe if you do the right thing for the patients, the business and our shareholders will be rewarded for that. So thanks for all the support. Happy to continue to share progress as we get into Q2 and beyond. So thanks again for everybody's support, and we will talk to you guys soon. You can disconnect now, operator.

Thank you for your participation in today's conference. This concludes the program. You may now disconnect.

Good day, and thank you for standing by. Welcome to UroGen Pharma's Fourth Quarter 2025 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

Thank you. Good morning, everyone, and welcome to UroGen Pharma's Full Year 2025 Financial Results and Business Update Conference Call. Earlier this morning, we issued two press releases. The first providing an overview of the refinancing of our debt facility with Pharmakon Advisors, and the second, providing an overview of our recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2025. Both releases can be accessed on the investors portion of our website at investors.urogen.com.

Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer.

On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to JELMYTO and ZUSDURI, our ongoing and planned clinical trials and nonclinical studies, the commercial and clinical development milestones, market and revenue opportunities, our commercialization and long-term growth strategy and expectations as well as anticipated data, regulatory filings and decisions, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals and 2026 financial guidance, among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Urogen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Officer.

Thanks, Vincent. Good morning, and thank you for joining us today. Our top priority is the commercial launch of ZUSDURI and recurrent low-grade intermediate risk non-muscle invasive bladder cancer, a pivotal step in advancing our long-term growth strategy.

As we outlined in our earnings release this morning, we are encouraged by the early 2026 trajectory following the permanent J-code becoming effective January 1.

ZUSDURI revenue in 2025 was $15.8 million reflecting early launch dynamics as we work through typical reimbursement and operational steps necessary to build the foundation for broader adoption. With a permanent J-code now in place, a key barrier to adoption has been removed, facilitating more predictable patient access.

Since that milestone, as expected, we have seen a clear acceleration across key launch indicators, including the number of new and repeat prescribers, patient enrollment forms and new patient starts. Overall, we are pleased with how the launch is unfolding in early 2026, and we are on track with the assumptions we've made around its trajectory.

ZUSDURI addresses a large and underserved market. And based on our assumptions regarding market penetration, pricing and physician adoption, we believe ZUSDURI has the potential to achieve greater than $1 billion in peak revenue.

Importantly, ZUSDURI provides the first and only medication approved by the FDA and that can provide patients with a primary office-based therapy that can result in extended recurrence and treatment-free living.

Turning to the rest of the business. JELMYTO generated net rep product revenue of $94 million for the full year 2025, reflecting continued underlying demand growth.

We are also advancing our pipeline in a disciplined manner UGN-103, our next-generation formulation of ZUSDURI demonstrated compelling complete response results in the Phase III UTOPIA trial, consistent with the ENVISION study. We remain on track to submit an NDA and recurrent low-grade intermediate risk non-muscle invasive bladder cancer in the second half of 2026, with potential FDA approval in 2027.

With a clear regulatory pathway established for UGN-103 and low-grade IR non-muscle invasive bladder cancer, we are evaluating its potential in additional bladder cancer settings, including as an adjuvant in intermediate and high-risk none-muscle invasive bladder cancer as part of our broader life cycle strategy.

UGN-104, our next-generation formulation of JELMYTO, continues to progress through Phase III with enrollment expected to complete by the end of 2026.

Finally, following the refinancing of our term loan with Pharmakon, we have further strengthened our balance sheet and enhanced our financial flexibility. Together with our existing cash on hand, this refinancing provides additional nondilutive capital that supports our operating plan and allows us to continue executing our strategy in a disciplined manner.

Importantly, our fortified balance sheet enables us to fully support the ongoing sistered launch, advance our next-generation pipeline and thoughtfully pursue life cycle management opportunities over time. We believe this approach positions us well to allocate capital responsibly and create long-term value for patients and shareholders. I will now turn the call over to Mark for a clinical update. Mark?

Thank you, Liz. As a reminder, the ENVISION trial, which supported approval of ZUSDURI, demonstrated an approximately 80% complete response rate at 3 months. Importantly, among those patients who achieved a complete response probability of remaining an free at 12 months was approximately 80% by [ Kaplan-Meier ] estimate and at 24 months was approximately 72% by [ Kaplan-Meier ] estimate. In practical terms, that translates to a substantial proportion of patients expected to remain disease-free 2 years following treatment.

ZUSDURI is delivered as a convenient 6 dose regimen in the outpatient setting and does not require surgery or maintenance therapy. Taken together, these clinical and practical advantages support ZUSDURI's growing role for adults with recurrent low-grade intermediate risk and NMIBC, and position it competitively within an evolving treatment landscape.

Beyond the clinical data, I would note that what I'm about to share reflects anecdotal feedback from early adopters and patient conversations rather than formal study outcomes. For those discussions, we are hearing that ZUSDURI is integrating smoothly into routine practice. Physicians have commented on the simplicity of administration and the ability to incorporate the 6-dose regimen into existing patient workflows. And without requiring procedural changes or additional infrastructure.

Several urologists have shared that following their first experience with ZUSDURI, the process becomes predictable and manageable within the normal flow of their clinic. We are also hearing encouraging feedback from the patient perspective for individuals who have undergone multiple TURBT procedures, having a nonsurgical treatment option delivered in the outpatient setting has been meaningful. Physicians have described patients as being receptive to and in some cases, enthusiastic about the opportunity to avoid additional surgery under general anesthesia while maintaining disease control.

Taken together, while anecdotal, this early feedback reinforces our confidence in how ZUSDURI clinical durability and practical ease of use are translating into real-world adoption.

Turning now to the pipeline. UGN-103 is our next-generation [ mitomycin ] based formulation for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We are developing UGN-103 to build on the foundation established by ZUSDURI. UGN-103 is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure.

Results from the ongoing Utopia Phase III trial demonstrated a 77.8% complete response rate at 3 months. We have aligned with the FDA that the data from this trial can support an NDA submission in this indication, and we are planning to submit in the second half of 2026, which would position us for potential FDA approval in 2027.

As Liz mentioned, we are evaluating life cycle management and pipeline expansion opportunities for UGN-103 beyond low-grade intermediate risk disease. This includes exploration of its potential in high-grade NMIBC as well as an adjuvant setting for intermediate-risk patients. We anticipate holding [ Type C ] meetings with the FDA in the second or third quarter to align on the development plans for these programs. We expect both studies to be randomized, controlled and event-driven trials.

Subject to regulatory alignment with the FDA, we intend to initiate the high-grade NMIBC study in the second half of 2026. We look forward to providing additional details as those plans are finalized.

UGN-104 our next-generation program for low-grade upper tract urothelial cancer continues to progress in Phase III with enrollment expected to complete by the end of 2026.

UGN-501 is our investigational next-generation [ oncolytic ] virus in development for high-risk non-muscle invasive bladder cancer. [ IND ] enabling studies are well underway and our goal is to submit the [ IND ] and initiate a Phase I clinical trial in 2026.

While our initial focus remains bladder cancer, we see potential to explore this platform more broadly beyond the [ Genitourinary ] system. Overall, we believe the recent progress made across our programs positions us well over the coming year with multiple clinical and regulatory milestones ahead. I will now turn the call over to David for the commercial update.

Thank you, Mark. I want to reinforce what Liz shared earlier. We are very encouraged by how the store launch is developing, and it continues in line with our expectations. The commercial execution we're seeing reflects the significant groundwork laid throughout 2025, as we are beginning to see that preparation translate into broader engagement across the urology community.

From FDA approval through year-end 2025, our focus was on intentionally building the commercial foundation required for long-term success. We expanded and trained commercial organization establish reimbursement pathways and work closely with urology practices to support operational readiness ahead of broader adoption. ZUSDURI generated $1.8 million in net product revenue in Q3, and $14 million in Q4, bringing full year 2025 revenue to $15.8 million. As discussed, these early quarters reflected the foundational launch phase during the miscellaneous J-code period.

As of December 31, 2025, we had 838 activated sites of care with 102 unique prescribers and 32 repeat prescribers. Payer execution continued to support access with over 95% of covered lives having open access to ZUSDURI by year-end.

The permanent product-specific J-code became effective on January 1, 2026. And since that time, we have seen a noticeable step-up in adoption and utilization trends through January and February. It's still early days, however, the directional indicators are consistent with our expectations that reimbursement clarity would support broader uptake. Importantly, we are not seeing any material friction points in reimbursement, logistics or treatment delivery.

Just as important, we are beginning to see greater engagement from community-based urologists. As expected, many community practices were more cautious prior to the permanent J-code going into effect, and we are now seeing growing participation as reimbursement processes normalize and confidence builds. We believe this shift toward increased community adoption will be an important contributor to growth as we move through 2026.

We are also tracking the conversion time line from Patient Enrollment Form or PEF to dosing. We've previously said that conversion cycle was in the 45- to 60-day range. reflecting the onboarding and workflow integration typical of a new product launch. Over the course of 2026, we expect conversion time to narrow as sites gain familiarity and operational efficiencies improve ultimately, moving closer to the 2- to 3-week time frame we see today with JELMYTO.

As we continue through 2026, our commercial organization is scaled to support the 8,500 urologists in our target universe who treat approximately 90% of the low-grade intermediate risk non-muscle invasive bladder cancer patients in the U.S.

Our focus remains on disciplined execution, expanding peer-to-peer education supporting appropriate patient identification and ensuring practices have the tools they need as adoption continues to build in a measured and sustainable way.

We have also begun to increase our investment in patient awareness initiatives, to complement our physician-focused efforts, ensuring that patients are informed about their treatment options.

Turning to JELMYTO. It generated net product revenue of $94 million in 2025. While growth has moderated for a more mature product, we continue to drive consistent engagement and steady demand across the treating community based in part on compelling durable complete response data.

Importantly, the expansion of our commercial organization in support of ZUSDURI, also enhances our overall urology presence, which we believe can provide incremental support to the JELMYTO franchise over time. I will now hand it over to Chris to discuss financials.

Thank you, David. Revenues were $109.8 million for the year ended December 31, 2025, and compared with $90.4 million in 2024. The 21% year-over-year increase was driven by the commercial launch of ZUSDURI in 2025 as well as increased sales of JELMYTO. .

Research and development expenses for the year ended December 31, 2025, were $67.1 million compared with $57.1 million in 2024. Year-over-year increase was primarily driven by higher manufacturing costs ZUSDURI, which are recognized as R&D expenses prior to receiving FDA approval, costs associated with the Phase III trials for UGN-103 and UGN-104 and the acquisition of UGN- 501, partially offset by lower clinical trial costs and regulatory expenses in connection with ZUSDURI.

[ Selling ], general and administrative expenses were $155.1 million for the full year ended December 31, 2025, compared to $121.2 million for the full year 2024. The year-over-year increase in SG&A expenses was primarily driven by the story commercial activities, including the sales force expansion following the ZUSDURI approval in 2025 as well as an increase in overall commercial operation costs.

Financing expense related to the prepaid forward obligation to [ RTW ] Investments was $18.5 million for the year ended December 31, 2025, compared with $23.4 million in the prior year. The decrease was driven primarily by changes in underlying assumptions for remeasuring the effective interest rate.

Interest expense on our prior $125 million term loan facility with Pharmakon Advisors was $15.3 million in 2025 compared with $12.5 million in 2024. The increase was primarily attributed to the interest expense on the $25 million third tranche of the loan that was funded in September 2024.

We reported a net loss of $153.5 million were $3.19 per basic and diluted share for the year ended December 31, 2025, compared with a net loss of $126.9 million or $2.96 per basic and diluted share in 2024. As of December 31, 2025, our cash, cash equivalents and marketable securities totaled $120.5 million.

As Liz mentioned, Today, we announced that we have entered into a second amended and restated loan agreement with Pharmakon Advisors, providing for a senior secured term loan facility of up to $250 million, consisting of two tranches. The initial tranche of $200 million was funded at closing, we'll use to refinance our existing $125 million term loan facility and provide additional nondilutive capital. The agreement also includes a second tranche of $50 million, which may be drawn at our discretion through June 30, 2027, subject to customary conditions.

All outstanding loans with Pharmakon will accrue interest at a fixed rate of 8.25% and will be repaid with 4 equal quarterly principal payments beginning in the first quarter of 2030.

The facility includes customary prepayment provisions, including applicable premiums and [indiscernible] whole amount. We believe this refinancing enhances our financial flexibility and provides additional nondilutive capital to support continued investment in the ZUSDURI launch, life cycle management initiatives and advancement of our pipeline while maintaining a disciplined approach to capital allocation.

Finally, turning to guidance. We are providing 2026 guidance for JELMYTO net product revenue and total company operating expenses. Given that the ZUSDURI remains in the early stages of its launch, we are not providing formal sales guidance for 2026 at this time.

For the full year 2026, net product revenues for JELMYTO are expected to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over 2025. Full year 2026 operating expenses are expected to be in the range of $240 million to $250 million, including noncash share-based compensation expense of $20 million to $24 million.

The anticipated year-over-year increase in company operating expenses is primarily driven by three factors: an increase in noncash share-based compensation expense attributable to a higher stock price at the 2026 grant date and an overall increase in employee grants, the annualization of costs associated with our sales force expansion following the ZUSDURI approval in 2025 and our life cycle management plans for UGN-103. That concludes our prepared remarks. We will now open up the call to questions. Operator?

[Operator Instructions] Our first question comes from Kelsey Goodwin with Piper Sandler.

Maybe first, I know you're not providing anything on the patient enrollment forms, but do you have any color or commentary you can provide there and maybe a way we could benchmark it to what you're seeing with JELMYTO, what you saw in their launch. And then in terms of the potential guidance for ZUSDURI, I guess when might you be able to provide that? Or would that be maybe a 2027 thing?

Yes. I'll ask Chris to answer the second question and then David can answer the first question.

It is early in the launch, as we said, and there are certain variables that can affect the near-term uptake. So once we get a better visibility to steady-state demand, I would say, at least 2 quarters post the permanent J-code then we could consider providing formal guidance for the ZUSDURI.

Kelsey, it's David. With regard to patient enrollments, as expected, since the permanent J-code became effective at the beginning of the year, we are seeing a step-up in a number of key indicators. So [indiscernible] being one of them, and that's really, in large part due to the fact that we have new writers as well as growing repeat writers.

Kelsey, just to put a little bit of a finer point on that, to your point about how is it doing versus JELMYTO. I will tell you that and cautiously tell you that all of our indicators in the month of February, surpassed JELMYTO. So if you think about patient enrollment forms, you think about new patient starts and doses, we are now tracking ahead of where JELMYTO is. So take that into consideration when you think about the number for the year that we've said we're comfortable with where our guidance is. And if you think about it versus where JELMYTO is, I think that will show you that we are on track for to hit that number. So I just want to -- that's a little bit more color. I know everybody's wanting specific numbers, but I think that's the best we're going to be able to do, but I think that should give everybody confidence in kind of where we are right now.

Our next question comes from Raghuram Selvaraju with H.C. Wainright.

I just wanted to drill down on the prescribers and repeat prescribers for a second. So two questions here. Firstly, among the repeat prescribers, can you comment on the trend in this number? And if you're seeing it steadily picking up month-over-month, quarter-over-quarter, and secondly, with respect to those prescribers who have deployed the story but are not yet repeat prescribers, have you received any feedback from this group indicating how likely they would be to become repeat prescribers? And are there any specific considerations that are emerging that would prevent them from becoming repeat prescribers?

Thanks for the question. In terms of repeat prescribers, we are seeing steady growth in -- I'll just comment in both new and repeat prescribers. So to your point around repeat prescribers, what we see with them is that once they have a very positive experience with a patient and the workflow becomes incorporated into their practice, and they have the confidence around reimbursement, which is now reinforced with the effectiveness of a permanent J-code that's really what enables them to become repeat prescribers.

With many of the new prescribers, what they're really waiting to see is -- they typically want to make sure that they have a clean claim submission and they get reimbursed. And as their practices become more familiar with the medicine, implementing it in their workflows, they are very likely to become repeat prescribers. And so what we've heard from the prescriber base is that it's a steady growth in as they become more familiar, they tackle more patients.

Very helpful. And then just quickly on life cycle management. I was wondering if you have a sense assuming timely submission of UGN-103, approximately when you might potentially be in a position to introduce it into the market in the United States?

And secondly, if you could comment at all at this juncture on what you expect the dynamics to be between UGN-103 and ZUSDURI and how you're thinking about 103 relative to ZUSDURI from a commercial positioning standpoint.

Yes. So the plan would be to not introduce it into the market until after we get a permanent J-code. So what we've discussed is that we would file this year you'll get approval in '27. And so then it would likely be the beginning of '28 when we would be in a position to launch it. And what we would do is the goal would be to transition to UGN-103 as quickly as possible. But because there's going to be a lot of confusion. So we have to make sure that we handle that very quickly, so to avoid any of that. And then at the point in time where we feel confident that we're not going to lose physicians and patients with ZUSDURI and that they'll switch to 103, then we'll make that with.

So we have -- we will be very purposeful about that. and then pull ZUSDURI as quickly as possible. So there won't be a lot of the -- to your point, the dynamic of 103 and ZUSDURI being on the market at the same time. That will happen obviously. There will be a transition period, but we want to make that transition period as quick as possible.

Our next question comes from Michael Schmidt with Guggenheim.

On ZUSDURI, as we -- could you just provide some more comment on current use, especially as we think about what types of patients are leveraging the story at this point in time. What percentage of patients are considered unfit for TURBT surgery as opposed to base that are fit and I'm just thinking of alternatives to surgery? And how do you expect that use parent to shift over the rest of this year? So that's question number one.

And then question number two, I think you did mention some potential life cycle management opportunities, especially for UGN-103, including evaluation at the [indiscernible] therapy. And I'm just curious, basically market research, how well does the concept of acumen therapy in general resonate with patients as opposed to just using therapy as a replacement of surgery instead of as an add on, how do you think about that?

Yes, sure. David can answer the first. And then Mark, please be prepared to answer the question around life cycle management.

Michael, this is David. In terms of your question, I think the first thing I'll say is that physician customers have been very enthusiastic about the compelling data surrounding ZUSDURI. As we've talked about and as we've gained more experience in the market that complete response and durability of response really does resonate and they do see it as a paradigm change.

In terms of the patient types that they are giving ZUSDURI, while not a precise science, I will say they're using as we expected. So the first would be people who recur early. Second would be those who have frequent recurrences. And third, those who they feel just shouldn't go through another surgery. So we're hearing patients across the board, and that's what gives us a lot of confidence that the value proposition is getting across to them. That's supported by the fact that we have a permanent J-code now in 2026, has opened up utilization as we discussed in more community practices, and it's really consistent with what we -- how we thought about the launch at this point in time.

Michael, thanks. And with respect to the life cycle management question, the expansion of the 103 in the adjuvant setting would be in the setting of treating patients where we currently believe TURBT would be obligatory so that would be in patients with a new diagnosis where a patient would have had a transitory section to make a diagnosis likely for new onset inners disease as well as neurons, high-grade disease where primary therapy would not be the standard of care, but adjuvant therapy would.

So we think there will be enthusiasm for it in both settings, and it would expand markedly the opportunities for patients to take advantage of the benefits of 103 in both settings. So adjuvant for new diagnosis intermediate-risk disease as well as adjuvant therapy for patients with high-risk disease.

And just to answer -- add a little bit more color on the patient dynamics, but from the adjuvants of how that's being used today, we don't really know. Obviously, we don't track that. we do know some physicians today are using it in the adjuvant setting for the recurrence. But we don't promote that, right? Because our data is clearly without surgery. And I think that, that's very important because the idea of not having to go through surgery while physicians don't love that -- may not love that idea. Some of them, patients really do.

And the reality of it is, is that the 80% complete response and the durability that we've shown, keep in mind that is without surgery. And so we do want to -- while we do recognize that some physicians may be less comfortable they'll do it in the adjuvant setting even today we do want, ultimately, for them to use it without surgery because we think that's in the best interest of the patient, frankly. And we think that, that also differentiates us versus all of our competitors. So anybody coming in as they're coming in, they're in the adjuvant setting. And right now, we're the only ones that are showing it as a primary. And I think that that's going to be really important as we go forward.

Our next question comes from Leland Gershell with Oppenheimer.

I'm glad to hear the favorable update. We have two, one just on the commercial side with ZUSDURI, as you develop that market. I wanted to ask what you're seeing in terms of the community versus academic centers that are that are kind of buying into it. Is it different than how JELMYTO proceeded in its early launch?

[ To ] your question around channel mix, it is a little bit different. I think as you saw with JELMYTO is very heavily concentrated with hospitals, particularly in the beginning. What we saw in 2025 with ZUSDURI is that we saw about 60% utilization in a hospital-type setting. And obviously, with the effectiveness of a permanent J-code, we expected that, that would actually bring on more community users. And since the beginning of the year, we have started to see that happen. And as we sit here at the end of February, I can tell you that the mix of settings has started to pivot toward the community setting. So we're looking at about 50-50 right now for ZUSDURI.

And what we do continue to -- we would expect to see is that as these community settings come on board, they get experience with using the product. filing claims and getting reimbursed, we will continue to see continued growth in the community setting over time.

Okay. Great. And then development question. You had mentioned you're looking at sister the adjuvant setting in high risk. Just wondering if you could share more detail on that and perhaps other expansion opportunities in high risk, could you be looking at the story in combination with others? And then in the adjuvant setting, would that be in [ DCG ] naive with [ TERP ] or would it be -- would there be an opportunity in [ DCG ] unresponsive? Just curious if you can share any more details here.

So I think there are a lot of opportunities in high-risk disease. One area we're particularly interested in is in the [ DCG ] on responsive capillary high-grade disease where we think there is a real opportunity. So we are in the process of finalizing a protocol to launch an adjuvant trial in high-risk disease. And obviously, we'll be happy to share details when that protocol is finalized. But we do think that ZUSDURI all by itself or in this case, it would be 103 as a single agent would be very useful for this particular population, and that's where we would start our investigation. Liz want to comment further on the possibility of combining with other agents, however.

Yes. I mean I think we've definitely considered that, but it would be good. We definitely want to see how we do with just monotherapy post-TURBT but absolutely open to and have been looking at potential combinations. So we'll do that as well. I mean, it's in it makes sense for us to be in multiple areas and multiple patient populations. And so our ability to quickly launch the incremental clinical studies and broaden the patient utilization, is a core strategy for us. And that's how we will ensure a long-term sustainable growth is by really being able to hit all of the patient populations in non-muscle invasive bladder cancer. There's no reason why it shouldn't work across the board, and that's our intention.

Our next question comes from Paul Choi with Goldman Sachs.

My first question is, Liz, can you maybe offer a framework about how you're thinking about the level of investment in promoting the store launch given that you eventually plan to transition to UGN-103 in the future, and just sort of what level of investment is needed here to generate a positive return on all the investment you're putting into the product currently and in the past?

And then my second question is I think in the past, you've indicated that you thought you had enough capital to sustain yourself to profitability. And so I guess, how are you thinking about prioritizing capital allocation with this new loan on the forward here? And do you feel like now your capital position is finally where you need it to be to get to profitability?

Sure. I'll answer the first, and then I'll ask Chris to talk about the longer term sustainability of the financials and our investment.

I think where we are with investing in ZUSDURI versus 103, we're investing in ZUSDURI like 103 doesn't exist. I mean we are doing everything we can to ensure the maximum opportunity and we will continue to do that. And I'll give you an example. We just had a new person joined the commercial team that was covered was one thing that I really appreciated and that is we have the resources. So we have resourced this launch like a [indiscernible] resource. And there is nothing no stone that we're leaving including engaging in patients.

So while we're not doing broad-based [indiscernible], we clearly are trying to reach patients in a more targeted manner. So I would say, again, absolutely fulfilling every aspect of the launch. So we're not looking at it as this is just temporary. And in 2028, we're going to have -- we're not looking at it like that. We're looking at it because what we build for ZUSDURI will be the foundation for UGN-103. So we're going after an aggressive way, and again, not moving commercial opportunity. So I feel really good about where we are from that standpoint, and we'll continue to do that. And I'll just ask Chris to sort of comment on sort of the expenses and where we're going from here.

Yes. And thanks, Paul, for the question. So as we said before, I mean, the path to profitability is really tied to the story of launch and the uptake, and we're on track there. The purpose of the refinance really accomplished two things for us. One, it meaningfully reduced our cost of capital. So the prior loan had a 7.5% plus 3 months so for variable rates, so call it 12% interest rate and we reduced that now down to 8.25%. And then two, it gave us financial flexibility. So one it extended the repayment period was going to start second quarter next year, now starts first quarter of 2030 and did bring in additional nondilutive capital to further build out the balance sheet. But to be clear, we'll remain disciplined in our approach to capital allocation, balancing path to profitability and then also making sure that we're investing in the long-term growth strategy.

Yes. And I'll just add that the addition of the $50 million or $75 million does not change what we've said before around path to profitability, right? It gives us a cushion and gives us more flexibility. But it doesn't -- we're not -- we didn't do that because we needed that money to get to profitability, but it definitely gives us flexibility. So just to be really clear, we haven't changed our commentary around path to profitability.

[Operator Instructions] Our next question comes from Aydin Huseynov with Ladenburg.

I've got a couple. One on ZUSDURI, one on UGN-501. For ZUSDURI, I appreciate confirming the long-term guidance for the story. So I just wanted to better understand, maybe if you could provide some color in terms of when do you think these [indiscernible] would occur? Is it 2035, 2040. And what would happen after you reach those peak sales?

And for UGN-501, the question is I just wanted to better understand the RTGel technology and how that would help UGN-501 oncolytic virus to be differentiated from other oncolytic viruses. And whether you'd need a primer to activate the virus?

I'll ask Chris to answer the first question, and then we can turn over to Mark to answer around 501.

Thanks. So I mean path peak or time to peak, I would assume roughly 4 years to peak. So now that we have the J-code, a 4-year ramp to peak is reasonable.

And Mark, do you want to just talk about 501 with and without RTGel.

So as you -- as many who are listening now, our current plan to launch a Phase I study in 501, which we will do this year in high-grade disease is an aqueous-based preparation that is preceded by the use of an activating agent that you were alluding to [indiscernible]. We are in the process of studying how long dwell time or longer dwell time could potentiate the efficacy of the virus in the setting in which we will initially explore its use, which is obviously intravesical therapy for bladder cancer. So we are in the process of doing that currently.

Theoretically, and again, this is speculation currently, but we are looking into this right now. We believe there may be an advantage to a longer dwell time, which may obvious the need for additional interventions prior to introduction of the virus, but that's currently under investigation, and we'll obviously share details when we have more to share.

That concludes today's question-and-answer session. I'd like to turn the call back to Liz Barrett for closing remarks.

So I just want to say thank you to everybody for the support. As you heard today, very excited about how things are going with the launch. We gave information that hopefully gives you the confidence that where we are. We have -- we're starting out the year very strong. So we -- obviously, we'll look forward to sharing the all of the information from the Q1 earnings. But suffice it to say that we're excited about where we are. We think we're in a great position to hit our goals and hit all of the milestones that we expected on ZUSDURI, which I might do doing well as well and then want to focus in the back half of the year around expansion into other areas.

So I think from a company perspective, we feel like we're in a great position. We're in a great financial position. Things are going really well with the launch. We're executing against our pipeline and expanding so that we actually are in a position where we see the future being a long-term sustainable growth and being able to do that. So again, thank you for everybody for hanging in there for all these years. We're finally I think it's a place where we've all been working towards and appreciate the support. So we'll be keeping everybody up to date and look forward to seeing some of you guys at the conference tomorrow. So thanks a lot. You can disconnect now, operator.

This concludes today's conference call. Thank you for participating. You may now disconnect, and have a great day.

Good morning, and thank you for standing by. Welcome to the UroGen Pharma Third Quarter 2025 Earnings Call. [Operator Instructions] Please be advised today's conference is being recorded.

I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

Thank you. Good morning, everyone, and welcome to UroGen Pharma's Third Quarter 2025 Financial Results and Business Update Conference Call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended September 30, 2025. The press release can be accessed on the Investors portion of our website at investors.urogen.com.

Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer.

On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to JELMYTO and ZUSDURI, our ongoing and planned clinical trials and nonclinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations as well as anticipated data, regulatory filings and decisions, ZUSDURI being the primary growth driver for UroGen, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals and 2025 financial guidance, among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements.

I'll now turn the call over to Liz Barrett, Chief Executive Officer.

Thank you, Vincent. I'd like to address what I know is on everyone's mind, and that is the progress of the ZUSDURI launch. While we had expected a faster uptake, there are many factors that support our belief that the near- and long-term opportunity for ZUSDURI is on track.

The preliminary demand revenue for October is more than double the previous 3 months, demonstrating increased usage and adoption. Importantly, our patient enrollment forms, or PEFs, in Q3 were actually on track with our initial expectation. But as we've communicated, it is taking longer to convert a PEF to an actual patient being dosed. We believe the delay is driven solely by logistical and operational challenges, including reimbursement concerns with a miscellaneous J-code. PEF continue to grow and are currently on pace with JELMYTO after only 4 months on the market.

Since launch, physician enthusiasm has been encouraging. There's clear recognition of the need for new therapeutic options for these patients, and our market access team has executed well to secure broad coverage across major payers. I am pleased to say that we do have paid claims.

Feedback on the clinical profile of ZUSDURI continues to be very positive with high intent to prescribe by physicians. As we anticipated, usage has been greater in the hospitals than in community practices, but in both settings often requires formal approvals before physician ability to use. Remember, we are changing the way physicians practice and ZUSDURI is the first and only FDA-approved treatment for patients with low-grade intermediate risk non-muscle invasive bladder cancer.

ZUSDURI addresses an estimated $5 billion annual market, and we are well positioned to take advantage of this significant opportunity. We remain confident in the long-term potential for ZUSDURI to deliver an important advance for patients, becoming standard of care and delivering over $1 billion in peak revenue. We expect to see an acceleration in adoption once the permanent product-specific J-code goes into effect on January 1, 2026. David will provide more details on the launch in a few minutes.

Turning to JELMYTO. We delivered another solid quarter with net product revenue of $25.7 million, representing a 13% increase in underlying demand revenue over the same period in 2024. Now 5 years post launch, JELMYTO continues to demonstrate its clinical value and prescriber confidence remains strong. With our expanded field team, we see additional opportunities to drive further growth.

On the clinical front, we continue to advance our next-generation mitomycin program. We are pleased to see the 3-month complete response rate from UTOPIA is consistent with what was observed in the ENVISION trial and our plan for a new drug application or NDA submission and approval is on track. We plan to submit an NDA for UGN-103 in the second half of 2026 with potential approval anticipated in 2027.

This is a very exciting time for UroGen. We've entered a new phase of growth from a position of strength with a solid balance sheet, a capable and focused team and a portfolio that positions us for durable long-term success. We remain guided by our mission to bring meaningful new treatments to patients and deliver sustained value for our shareholders.

I will now turn the call over to Dr. Mark Schoenberg. Mark?

Thank you, Liz. In the ENVISION study, ZUSDURI demonstrated a compelling and clinically meaningful profile with 80% of patients achieving a complete response at 3 months and 80% of those patients remaining disease-free at 12 months and remarkably, 72% at 24 months. It's important to note that ZUSDURI median duration of response has not been reached. This level of sustained response is unprecedented and highly meaningful for a population that has historically faced repeated surgeries and the burden of chronic disease management.

The growing body of evidence supporting ZUSDURI was recently highlighted in a comprehensive review published in Reviews in Urology this October by Dr. Sandip Prasad, one of our leading clinical investigators. This article reviewed results from our 3 late-phase clinical trials, OPTIMA II, ATLAS and ENVISION and underscored the consistency and robustness of ZUSDURI’s clinical performance.

Importantly, the review also explored the patient perspective on ZUSDURI. Across multiple studies, including the Phase IIIb home installation study and sub-analyses of OPTIMA II and ENVISION, patients consistently reported that ZUSDURI was a less invasive, less painful and less time-consuming alternative to repeated TURBT surgeries.

Turning to UGN-103, our next-generation formulation for low-grade intermediate risk non-muscle invasive bladder cancer. UGN-103 is designed to offer practical advantages over ZUSDURI, including a shorter manufacturing process and simplified reconstitution. We've completed enrollment in the Phase III UTOPIA study and are very pleased to report that the 3-month complete response rate was 77.8%. This is consistent with results from the ENVISION clinical trial, reinforcing the strength and productivity of our RTGel platform.

In October, the FDA agreed that our pivotal study, UTOPIA, can serve as the basis for a new drug application. We plan to submit the NDA in the second half of 2026 with approval anticipated in 2027. In June this year, we initiated a Phase III trial of UGN-104, our next-generation mitomycin-based formulation for low-grade UTUC. We expect UGN-104 will follow a similar regulatory pathway to UGN-103.

Turning to UGN-301, our anti-CTLA-4 monoclonal antibody being evaluated for high-grade disease. We have completed a Phase I dose escalation study assessing UGN-301, both as monotherapy and in combination with UGN-201 or gemcitabine. The study confirmed proof of concept for our RTGel as a viable platform for local delivery of complex immunotherapies.

UGN-301 achieved sustained bladder exposure of zalifrelimab with minimal systemic absorption, demonstrating our ability to mitigate anti-CTLA-4 related toxicities. The treatment was well tolerated with a favorable safety profile and efficacy signals were observed across cohorts. However, the overall clinical profile did not warrant advancement to a Phase II study. As such, we have made the strategic decision to discontinue the UGN-301 program and focus our resources on UGN-103 and UGN-501 in high-grade non-muscle invasive bladder cancer. We plan to share safety and efficacy data in a future publication.

The important takeaway from this program is that it successfully validates our ability to locally deliver complex immunotherapies using our RTGel technology, a capability we believe will be foundational as we advance future oncology programs. One such program is UGN-501, our next-generation oncolytic virus acquired earlier this year. UGN-501 is designed to selectively destroy cancer cells while retaining potency and triggering a robust immune response. We are pleased with the results we are seeing in our early work with IND-enabling studies ongoing and planned initiation of a Phase I trial in recurrent non-muscle invasive bladder cancer in 2026 with additional potential applications beyond the urinary tract.

I'll now turn it over the call to David Lin for a commercial update.

Thank you, Mark. I will spend most of my time today discussing the ongoing launch of ZUSDURI. Overall, we remain encouraged by the strong engagement we're seeing across the urology community and the early commercial traction we've achieved while also recognizing the headwinds that accompany the introduction of a new therapy.

Our commercial infrastructure is now fully operational. By early August, we onboarded, trained and deployed 30 new sales representatives, bringing our total to 82 in the field. Along with our regional operations managers, field reimbursement managers and nurse educators, we now have approximately 130 customer-facing professionals supporting ZUSDURI as well as JELMYTO.

As Liz mentioned, ZUSDURI generated sales of $1.8 million during the third quarter, and we're pleased to report a preliminary demand revenue estimate of $4.5 million for October, reflecting encouraging early momentum in Q4.

From launch on July 1, 2025, through the end of October, there were 54 unique ZUSDURI prescribers and 16 repeat ZUSDURI prescribers. I'd like to spend a few minutes highlighting what's driving these numbers as well as some of the challenges we're addressing.

First, we are very encouraged by the level of interest we're seeing in the urology community. Awareness among urologists is strong, and we're seeing consistent engagement with our team to better understand ZUSDURI’s clinical profile and appropriate use in eligible patients.

Second, market access progress has been excellent. ZUSDURI is now broadly accessible to patients through commercial, Medicare and Medicaid insurance programs with open access to more than 95% of covered lives and approximately 296 million eligible patients.

Third, operational execution remains a major focus as it is a complex network and what we believe is the biggest driver of delayed treatment. We are partnering closely with practices and hospitals to ensure sites are prepared for ordering and administration, including distributor onboarding, pharmacy workflows and clinical training.

We now have nearly 600 sites activated and are ready to order and administer ZUSDURI. It's important to note that activation reflects site readiness, not necessarily that a patient has been treated. So it remains an early indicator rather than a measure of utilization. Still, it is a positive sign that the infrastructure and operational readiness for adoption continue to expand.

We closely monitor patient enrollment as a leading indicator of demand. When a physician identifies an eligible patient, they submit a patient enrollment form, or PEF, to our hub, a clear intent to treat with ZUSDURI. Weekly PEF volumes are showing strong growth and are now equal to or in some weeks, greater than JELMYTO PEFs, reflecting increasing demand and intent to treat. We are, however, seeing an average a 45- to 60-day lag between PEF submission and patient dosing. We believe this is largely because many initial cases are occurring in hospital settings where formulary and P&T approvals can extend time lines.

Our field team is actively working to shorten that conversion window by providing education on streamlining reimbursement workflows, accelerating patient benefit verification and ensuring sites are fully ready to administer treatment. Over time, we expect conversions to narrow to 2 to 3 weeks, similar to JELMYTO. As these processes improve and clinical teams gain experience, we expect conversion rates to increase meaningfully in the months ahead.

As you are aware, we are also navigating the temporary use of the miscellaneous J-code, which adds administrative complexity for practices given that ZUSDURI is buy-and-bill drug. Many large community practices have indicated strong interest in treating with ZUSDURI once a permanent J-code is available. We were pleased to announce last week that we have been assigned the permanent J-code by CMS that will go into effect on January 1, 2026.

In the interim, we prioritized around 2,000 early adopter physicians who have shown a willingness to prescribe under a miscellaneous J-code. Once the permanent J-code becomes effective, we expect to see acceleration in adoption, primarily in the community setting, where physicians tend to be more cautious with new buy-and-bill therapies during miscellaneous J-code periods. This change will simplify reimbursement and significantly reduce several of the barriers we are currently seeing. Taken together, while the temporary J-code has presented near-term headwinds, we continue to see strong interest, expanding the site readiness and a clear path to broader adoption as we move into the first half of 2026.

Turning to JELMYTO. We're seeing continued demand growth and steady utilization among high-performing accounts. Our expanded sales force, which now also promotes JELMYTO alongside ZUSDURI, is helping us reach more urology practices with greater frequency and depth. In addition, gross to net adjustments have normalized further, providing a clearer view of consistent underlying revenue growth. Taken together, these trends reflect durable demand and strong commercial execution that continue to position JELMYTO as a standard of care for patients with low-grade upper tract urothelial cancer.

I will now turn the call over to Chris to review our financial results.

Thank you, David. Total revenues in the third quarter were $27.5 million, and this consisted of $25.7 million in JELMYTO sales and $1.8 million in ZUSDURI sales. JELMYTO sales in the same period of 2024 were $25.2 million. However, this included $2.6 million in CREATES Act sales. On an underlying basis, excluding CREATES Act sales, this represents 13% year-over-year revenue growth for JELMYTO, driven by both price favorability and volume growth.

R&D expenses for the third quarter of 2025 were $14 million, including noncash share-based compensation expense of $0.7 million. This compares to $11.4 million, including noncash share-based compensation expense of $0.6 million for the same period in 2024. The increase in R&D expenses of $2.6 million was primarily driven by costs associated with the Phase III UTOPIA trial for UGN-103, partially offset by lower clinical trial costs, manufacturing costs and regulatory expenses in connection with ZUSDURI.

Selling, general and administrative expenses for the third quarter of 2025 were $37.6 million, including noncash share-based compensation expense of $2.3 million. This compares to $28.9 million, including noncash share-based compensation expense of $2.9 million for the same period in 2024. The year-over-year increase of $8.7 million was primarily driven by ZUSDURI commercial preparation activities as well as an increase in overall commercial operation costs, including the expansion of the sales force.

We reported noncash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the third quarter of 2025, compared to $5.9 million in the same period in 2024.

Interest expense related to the term loan facility with funds managed by Pharmakon Advisors was $3.4 million in the third quarter of 2025, compared to $2.7 million in the same period in 2024. The increase was primarily driven by interest expense related to the third tranche of the loan that was funded in September 2024.

Net loss was $33.3 million or $0.69 per basic and diluted share in the third quarter of 2025 compared to a net loss of $23.7 million or $0.51 per basic and diluted share in the same period in 2024.

As of September 30, 2025, cash, cash equivalents and marketable securities totaled $127.4 million.

Turning now to guidance. We are providing revenue guidance for JELMYTO only at this point. We continue to expect 2025 JELMYTO net product revenues to be in the range of $94 million to $98 million. This implies year-over-year growth of approximately 8% to 12% over the $87.4 million in demand-driven JELMYTO sales in 2024. This excludes the $3 million in CREATES Act sales reported in 2024.

Guidance on full year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million, including noncash share-based compensation expense of $11 million to $14 million.

I'll now turn it back to Liz for summary remarks.

I want to take a moment to acknowledge that this era for UroGen is the result of many years of hard work in a challenging environment. The company was founded for this exact moment to deliver a better option for patients with bladder cancer, and we believe we can deliver that promise. The journey has not been easy, but we have demonstrated unprecedented clinical results where no other FDA-approved treatments exist. We are creating a new path and opportunity for patients, and it would not be possible without the UroGen team. And for them, I am grateful. We believe we will deliver on our commitment for sustainable and meaningful growth and the creation of shareholder value.

With that, we can open the call to Q&A.

[Operator Instructions] Our first question comes from Tara Bancroft with TD Cowen.

So my question is, I'm hoping you can maybe explain for us a little more specifics on the timing that you mentioned to revenue recording. I know you stated previously that 45- to 60-day time to treatment and then a similar time to remittance. But I'd really love to hear more on the actual timing that you observed in real time, like did it end up on the longer end of those ranges or even longer and especially for the remittance time where that ended up? And then any outlook on how you think that timing in Q4 could play out if that should stay consistent until the permanent J-code or not?

Yes. Great, Tara. Thanks for the question. And I'll ask David to sort of give you more information about why the 45 to 60, what we're actually seeing and then how we expect that to evolve over time. So David?

Tara, this is David. In terms of the time to treat first patients, really the main components are we have to do a benefit investigation. And because this is a new therapy, we are seeing a lot of prior authorizations. But the good news, as you know, is that we have very broad coverage across Medicaid -- I'm sorry, Medicare, Medicaid and commercial lives. But any time you have a new therapy, we anticipate some extra time with the prior authorization.

The other main element that we commented on is that we have to get sites to make sure they're set up. And as Liz commented, there's also -- because it's a new therapy, approvals needed to use the drug. So while physician interest is strong, there are a number of administrative things that we need to work through. We do expect that as we -- as practices get more experience and particularly as we turn the corner into 2026, we will see those times improve, and we will obviously head toward a much smoother path in terms of time to treating the first time to first dose.

And then I think on your second question on remittance, we have paid claims now. And on average, I think what we have experienced from -- in terms of what our practices our customers have told us is that it does take a little longer during the miscellaneous J-code. And so that's playing out as we anticipated. Thanks for the question.

Yes, I guess so. On only other thing, David, was how do we expect it to be in Q4 and then going into Q1?

Yes. Thank you, Liz. We expect the same dynamic to play out through Q4, Tara. And as we turn the corner into the first half of 2026. Much of that dynamic will start to wane, but it will take some time, but we do see gradual improvement across all those measures during the first half of '26.

Our next question comes from Michael Schmidt with Guggenheim.

It's Paul on for Michael. For ZUSDURI, I'm just wondering how much visibility you have into physicians who are waiting for the permanent J-code to kick in on January 1 to begin submitting those patient enrollment forms. Are there any qualitative metrics you could share on feedback from those docs? Or is there a way to quantify the sort of pent-up demand that's maybe being held up until the J-code is effective?

Yes. Great question, Paul. So I'll ask David to comment and may add some commentary myself at the end. But David?

Yes. Thanks for the question. We do hear from quite a few physicians, particularly in the community setting that they are interested in prescribing ZUSDURI, have identified patients, but really want to wait until January until the permanent J-code is in effect. So that's been encouraging in terms of understanding the demand and also having the transparency from the customers as to when they anticipate starting. So we're going to do everything we can during the fourth quarter to make sure they are set up. So that all they need to do is really activate the patient enrollment form come January 1. But it is really encouraging what we're seeing so far.

Yes. And I'll just make a couple of comments just on my personal experience going out to the field and talking to doctors, to practice managers. And one of the things that David mentioned around administrative approvals, I think we're seeing more of that now that you've seen the consolidation in private equity. You've seen the buyout of -- from Cardinal. So we are seeing more sort of top-down where the practice is saying, no, you can't prescribe it prior to getting a J-code.

So I think my experience anecdotally is that more physicians than not and more practices than not are waiting, which is why we have a good outlook for what we expect to see going into 2026 because they have all identified patients, but have just made it very clear for several reasons that they will not prescribe until they see a J-code.

To your point about quantifying that, what I can say is that the team has a list, right? We haven't quantified that, but we have a list. And to David's point, our top priority is pulling through our patient enrollment forms, right, and getting P&T committees. That's our #1 objective. But the second objective is ensuring that all of those patients and physicians who have said to us I have patients identified. And then once we get into the new year, I will prescribe with a permanent J-code.

To David's point, we're making sure that they're ready to go as quickly as they can be when we do get to the new year. So that's our second priority. But priority #1 is we have a lot of tests, as we've said many times, the top of the funnel is actually very strong. And it's just our ability to pull it through. And so that's got to be our #1 objective. And so hopefully, that helps, Paul, to provide some extra color.

Our next question comes from Kelsey Goodwin with Piper Sandler.

Congrats on the quarter. Two quick ones from us. In terms of the patient enrollment forms, I know you've mentioned you won't quantify those. But I guess, could you maybe provide some color and how those are tracking kind of month-over-month from a growth perspective? And then secondly, we've gotten a couple of questions specifically on the wording of demand revenue estimate. I guess that $4.5 million figure, is that the actual sales estimate for October or the implied demand 45 to 60 days later?

No, that would be closer to actual. It's not implied demand, but of the demand revenue, that would actually -- it's not implied. It's not like 45 to 60 days, it’s later. But a great question. So I'll ask David to sort of answer your first question.

Yes. On your question around the trend of enrollments, we are seeing very steady demand or steady growth in enrollment forms month-over-month. And while we're really in the second full quarter of the launch, early signs are that we are seeing that average per week continue to go up. So we're very encouraged by that demand. And as we mentioned, we're at that point where on some weeks, we're actually equal to or greater than JELMYTO. So it gives you a sense that we're crossing an inflection barrier there.

Yes. And the only other thing I'll say about the PEFs from -- without giving the actual number is it's very strong, right? And if our 60 days was 30 days or was 3 weeks, then you would obviously see a very different revenue number. So suffice it to say that October revenue that you've seen versus Q3, we're seeing the same trend in patient enrollment forms. And look, we don't give the number because it's a very clunky number and some fall out and then it's too much, but the number of -- a patient enrollment form, a patient has been identified.

And the other good news is that PEFs, we don't get PEFs for everybody. So on top of the PEFs, there's revenue that comes in through hospitals. So we have to take that PEF number and add something to it and then subtract from it for those. There's always a conversion rate, and we see that on still JELMYTO today. You're never going to get 100% of those. But Kelsey to say it's healthy is -- I think it's very healthy. And so I feel really good, which is why we feel very good about the outlook. If the patient enrollment forms weren't there, that's showing clear demand because the patient has been identified.

Our next question comes from Raghuram Selvaraju with H.C. Wainwright.

Firstly, I just wanted to drill down a little bit further on what you expect the granular quantitative impact of the J-code to be as soon as it comes online? And in particular, if you could comment on what you anticipate the reduction in lag time between the receipt of the patient enrollment form relative to actual patient dosing could be once the J-code takes effect. In other words, with this active J-code, will the lag time be reduced from 45 to 60 days to under 30 days? Or do you have a more granular sense of what the impact of the J-code is going to have on that time frame?

And then my second question is related to UGN-103. I was just wondering if you could give us some additional granularity on what the FDA is likely to consider sufficient longitudinal clinical data, including but not limited to the sustained complete response rate achieved in the UTOPIA trial for you to be able to file for approval of the product. So obviously, you've announced the 3-month data. We just want to know how much additional long-term sustained complete response data and any other efficacy parameters you will need to furnish in order to be in a position to file the UGN-103 NDA.

Yes. Thanks, Ram. I'll ask David to answer the first question, and then Mark will comment on the FDA.

Ram, in terms of your question around the impact of having a permanent J-code, what I can say to you is this, when you break down the overall components of having an enrollment form to getting a new patient treated, think about it as -- I think about it in 3 parts, right? There's the benefit investigation, which often entails a prior authorization. There's the initial site setup is to make sure that the actual site can order the product and that they're trained.

And then, of course, as Liz mentioned earlier on, we want to make sure that they have permission. So while physicians are interested in using it, they have to make sure that they have permission, whether it's in the hospital setting or in their practice. All of those things will improve over time, particularly as you -- as a practice treats a patient and they're on to the second patient. So you can imagine a lot of that starts to ease.

So we do anticipate steady improvement in terms of the time to new patient start. It will be gradual. It will not be an overnight sensation. It will just be something that we continue to work through. But the key to that is going -- as you go to a practice and you get deeper into the practice where they're treating more than one patient, a lot of that becomes much more standardized and they're not doing it for the first time.

The other question you had was around just -- the other component around J-code, it makes it a lot simpler for the office. Remember that during the miscellaneous J-code period, the primary thing that practices have to deal with is that they're doing a manual claim submission, and it takes on average about 2x the time to remittance as it would be when they have a permanent J-code. So once we have turned the corner into 2026, the claim submissions are going to be electronic and then the remittance will be considerably faster. That should increase their confidence in terms of reimbursement. And then when you add that to the overall operational readiness that we'll have, we do anticipate that overall adoption can accelerate.

And then the final point I'll make is to our comments, we have been actively setting up the sites of care. And that just means while they may not have treated a patient, they are operationally ready to order ZUSDURI. And so because we got out ahead of that, we realize that's going to be important for the first half of 2026. We do feel good that we're laying a good foundation in terms of supporting broader adoption.

Yes. And the only thing that I'll add to that, Ram, is right now with JELMYTO, it takes us -- it's about 2 to 3 weeks, right, from -- depending on the patient. So we expect to get similarly there. But I do agree with David that it's not going to happen January 1, right? It doesn't -- it's not a flip of a switch because the J-code is just one component of why it takes the 45 to 60 days. So you'll see that improve over time, but it will take some time to get there, and we will eventually get below 30 days. So Mark maybe comment on the UGN-103.

Yes. Ram, thanks for the question. So our expectation is, as we've previously announced publicly that we'd submit in '26 with expectation of approval in '27. And we'll -- our experience with the FDA and the ENVISION trial suggests that ultimately, they're going to want a preponderance of follow-up data around 12 months. So we would submit and then as we have done previously in a number of applications, update during the submission process. So that's probably what we'd be looking at with UGN-103 as well.

Our next question comes from Paul Choi with Goldman Sachs.

Along a similar line, I want to ask, do you think you can get the time between the enrollment form to revenue recognition down to where JELMYTO currently is in the time frame of 2026? Or will that be something that will take a little longer? Any color on that would be helpful.

And my second question is, as we look at your cash position and your net loss for the quarter, can you comment on whether you feel like you'll need additional capital in '26 just at the current run rate? Or are you assuming either the revenue side or the cost savings side will be sufficient to transition you to profitability relative to your current cash position?

Yes. Thanks, Paul. We can -- David can answer the first question and then turn it over to Chris to talk about the cash position. So David?

Paul, in terms of your question around getting the time to new patient start equal to that of JELMYTO, one of the things we'll be tracking very closely, and we're putting in a lot of extra effort, obviously, to accelerate. But we do anticipate that over the course of 2026, those times to new patient starts will converge. Exact -- it's hard to say exactly when that will be, but the key is we understand that the components of that. And so we have very deliberate plans and actions to actually do everything we can to shorten each component of that time from PEF to new patient start.

So the short answer is yes. It won't get there in 2026.

And then Paul, on cash, as you saw, we have a little over $127 million in cash. So we're well positioned to be able to deliver on our core priorities, the ZUSDURI launch and with the expectations around revenue growth and based off our current operational plan, we continue to believe that we do have cash to profitability. But we will continue to remain disciplined in terms of how we think about and be opportunistic future capital needs.

Our next question comes from Leland Gershell with Oppenheimer.

For David, wondering if you could share with us, I know it's early days and the J-code dynamic. But as you've progressed in ZUSDURI early launch, could you comment on kind of the ratio of community uptake versus institution? And is it fair to say that community practitioners are really still waiting for the J-code and there's a minimal contribution to demand from community? Or has there been sort of a somewhat of a rise in community demand as you progressed in the first couple of quarters?

Leland, thanks for the question. Launch to date, we're seeing approximately 35% to 40% of our patients treated in the community and roughly 60%, 65% in the hospital setting. As we have outlined even prior to launch, lot of the HCPs are going to find it advantageous to treat in a hospital outpatient setting just because of the economics. But we're very encouraged that the interest level in the community practice among those who are willing to treat right now and also with those who have indicated a sincere desire to treat come January 1.

So hopefully, that gives you a little bit of color. But one of the things I'll say is as we turn the corner into 2026, as the permanent J-code is in effect, we do anticipate the proportion of community physicians to steadily increase over the course of the year into the out years.

And again, early days, but I'm not sure if you -- I think you commented on this in the prepared remarks, but can you just give us some color on what the overlap is in historical JELMYTO users and their interest in ZUSDURI versus what may be untapped -- previously untapped urologists and their interest in ZUSDURI?

Yes. I think with JELMYTO, it was a little bit heavier in the institution. And today, with JELMYTO, it's probably half-half, 50-50. And so that gives you a sense. We do expect, though, because the patient population for LG-IR-NMIBC patients is largely seen in the community practices. We do expect, like I said, to continue to see more uptake in that community setting.

No. But I think what he's asking is of the JELMYTO, ZUSDURI, people are using ZUSDURI, how many of those are JELMYTO users, and a lot of them are Leland. So a lot of our initial usage of ZUSDURI has been with JELMYTO users. The good news is that we also are seeing some new physicians using JELMYTO because we're going in to talk about ZUSDURI. So as we've talked about before, with the expansion of the sales organization, we're seeing more doctors, and we have seen this reverse halo start to generate some demand for JELMYTO that we -- and physicians that hadn't seen before.

So to your point, absolutely, some of our first prescribers have been JELMYTO users, but not all of them, but definitely those familiar with JELMYTO, and we expect that to continue and the halo to continue into 2026.

Our next question comes from Aydin Huseynov with Ladenburg.

I got a couple. So could you remind us how long it usually takes for a patient to schedule a repetitive TURBT surgery? And if those are the same urologists, do you think they have more financial incentives to run another TURBT surgery or administer ZUSDURI?

Yes. Great, great question, Aydin. David, do you want to…

Yes. Thanks for the question. In terms of scheduling a TURBT, what we generally hear from our customers is it takes them 4 to 6 weeks to actually schedule one. So with respect to the alternative of using ZUSDURI, if they choose to administer ZUSDURI, it can be roughly right now. They've got to schedule the patient in. But again, it's basically -- it's based on the patient's desire and their schedules.

From a financial perspective, one of the things that we'll think about is a physician's fee for doing a TURBT is going to be in a couple of hundred-dollar range, and that is excluding any sort of fee for the actual hospital. And one of the things that we have been asked a lot in terms of the financial economics of ZUSDURI that our market access team can speak to is that there is ability to be positive from administering ZUSDURI. So -- and then importantly, because it can be done by a nurse, it does allow the urologist to actually attend to other matters. So hopefully, that gives you a little color in terms of the time to schedule and also the economics.

Very helpful. And another question I have on UGN-501, next-generation oncolytic virus. So can you help us understand the competitive landscape for UGN-501? And what are the possible parallels with the CG Oncology story?

So thank you. It is analogous, at least in terms of the type of asset and the purported mechanism of action that the CG asset utilizes in its effect on BCG refractory carcinoma in situ and associated papillary disease. So this is -- this falls into the asset class of developed for high-grade disease, high-grade non-muscle invasive cancer. The thing about the UGN-501 asset to keep in mind, although obviously, we are in IND-enabling stage and anticipate Phase I in '26 is based on what we know about this highly very specifically engineered virus, it has very specific replication advantages in terms of its potency, its replication speed and also its ability to affect both primary tumor cell lysis and an adjunctive antitumor immune response.

So it would be unfair at this stage to directly compare this asset to the CG asset. It's a similar class. We think it is a very, very potent and very promising molecule. And just to close, remember, this is an asset that we are going to be primarily developing in the context of treating patients with non-muscle invasive bladder cancer, starting with high-grade disease, but we also believe that it will have application beyond urologic oncology, and we are having internal conversations about the development of that plan as well. So something for the future to think about.

And I'm not showing any further questions at this time. I'd like to turn the call back over to Liz for any further remarks.

Great. Thank you. I just want to take the opportunity to say thank you to everybody on the call for joining. Hopefully, we've got a lot of things to look forward to over the next few months as we continue to accelerate adoption with ZUSDURI, deliver on JELMYTO revenue and importantly, advance our pipeline. So again, thanks, everybody, for joining, and we look forward to keeping you guys abreast. Thanks.

Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.

Good day, and thank you for standing by. Welcome to the UroGen Pharma Second Quarter 2025 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's Second Quarter 2025 Financial Results and Business Update Conference Call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30, 2025. The press release can be accessed on the Investors portion of our website at investors.urogen.com.

Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer.

During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to JELMYTO and ZUSDURI, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations as well as anticipated data, regulatory filings and decisions, ZUSDURI being the primary growth driver for UroGen, the potential benefits of our products and product candidates, future R&D development efforts, our corporate goals and 2025 financial guidance, among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements.

I'll now turn the call over to Liz.

Thank you, Vincent. On June 12, we achieved a defining milestone for UroGen with the FDA approval of ZUSDURI for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. This was truly a landmark moment for our company and importantly, for the 59,000 annual patients in the U.S. who face recurrent and repeat surgeries year after year with no approved alternatives.

ZUSDURI is the first and only FDA-approved pharmacologic treatment for adults with this disease and has the potential to fundamentally change the treatment paradigm and offer patients durable long-term recurrent and treatment-free living. We are proud to be leading that shift.

ZUSDURI is UroGen's second commercial product and marks our transition from a rare disease-focused company to a scaled multiproduct organization. Five years ago, we launched JELMYTO for the treatment of low-grade upper tract urothelial cancer. That experience laid the foundation for everything we're doing today. With ZUSDURI, we are entering a larger but less complex market.

The total available market exceeds $5 billion annually, and we are well positioned to penetrate the opportunity with our expanded sales team of 82 territories as of August 1, up from 50 previously. We have an experienced team with strong knowledge and relationships that will allow us to accelerate and guide the launch of ZUSDURI.

Our commercial organization has a deep understanding of how care is delivered in neurology from academic centers to high-volume community practices. Their established relationships and field insights position us well for a strong and disciplined launch.

Regarding the commercial launch of ZUSDURI, the initial focus is on setting up sites of care and driving clinical conviction. The team is focused on driving early adoption among urologists who previously prescribed JELMYTO and those willing to initiate treatment before a permanent J-code is assigned. This is a disciplined strategic launch built on learnings from our first product. As we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly. David will provide more details on the launch in a few minutes.

Turning to JELMYTO. I'm pleased to report a strong second quarter with net product revenues of $24.2 million, representing an 11% increase over the same period in 2024. JELMYTO continues to grow with strong underlying demand in the second quarter, demonstrating continued adoption and usage of this important therapy for patients. The value proposition of JELMYTO remains clear: durable responses backed by long-term data and real-world use. We are pleased with the results and acceptance received by urologists.

UroGen's long-term goal is to develop and commercialize a differentiated portfolio of treatments that address meaningful unmet needs across urothelial and specialty cancers. UGN-301, our anti-CTLA4 monoclonal antibody, continues to progress in both monotherapy and combination studies for high-grade non-muscle invasive bladder cancer. Meanwhile, our next-generation pipeline is advancing. The Phase III UTOPIA trial of UGN-103 for recurrent low-grade intermediate risk non-muscle invasive bladder cancer is now fully enrolled, and we expect initial complete response data by the end of 2025.

We will share this data with the FDA and gain agreement on the path forward to approval. If the trial is successful, we expect to file an NDA for this product in 2026. We've also initiated a Phase III trial in June of 2025 for UGN-104, our next-generation mitomycin-based formulation for low-grade UTUC.

Our balance sheet remains strong with $161.6 million in cash, cash equivalents and marketable securities as of June 30. We believe we have the necessary capital to fund the ZUSDURI launch while supporting the advancement of our pipeline and other strategic priorities. We will be thoughtful about potential opportunities to expand our portfolio for the long term while driving commercial success and profitability goals.

The team at UroGen has demonstrated their dedication and resilience while striving to make a meaningful impact for patients. To the urology community, particularly those participating in research as well as those publicly advocating support for our medicines, we could not do it without you. With 2 commercial products and advancing pipeline and the commercial infrastructure to scale, UroGen is well positioned for sustainable growth.

We are executing with discipline and purpose, and we remain deeply committed to delivering meaningful innovation for patients and generating value for our shareholders.

I will now turn the call over to Mark Schoenberg. Mark?

Thank you, Liz. As a practicing urologist, I've spent years managing patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We see the approval of ZUSDURI as a meaningful advancement in how we care for this population. And for the first time, we can offer patients and their health care providers an effective pharmacologic treatment that targets the underlying disease and offers a convenient office-based outpatient alternative to repeated surgeries. We view this as a significant shift in the standard of care.

Historically, transurethral resection of bladder tumor, or TURBT, has been the only real option for patients with low-grade intermediate risk disease. TURBT is an invasive surgical procedure. It requires general anesthesia and access to an operating room, and it carries risks, especially in an older population.

Patients are typically diagnosed with bladder cancer in their mid-70s, and many of these patients have comorbidities that make surgery under general anesthesia less than ideal. We also know this is a highly recurrent disease. Approximately 68% of patients experience at least 2 recurrences and 23% will have 5 or more. That means multiple surgeries under general anesthesia and an ongoing burden that takes a toll on both physical health and quality of life, not to mention the burden placed on partners, family and other caregivers.

In addition, repeated TURBT procedures may be associated with an increased risk of mortality. ZUSDURI offers a new nonsurgical treatment approach. ZUSDURI is administered as an intravesical installation via urinary catheter once a week for 6 weeks in a physician's office. No operating room, no general anesthesia and minimal recovery time.

In many cases, a trained nurse can perform the procedure right in the urologist's office. For patients, this means a much less disruptive experience. For medical practices, it means increased OR availability for more complex procedures and an efficient in-office option that can streamline treatment delivery. The clinical data supporting ZUSDURI are both robust and continuing to mature.

In our ongoing pivotal Phase III ENVISION trial, 79% of patients achieved a complete response at 3 months following the completion of treatment. Equally important, however, is the durability of that response. In bladder cancer, long-term disease control is what truly improves outcomes and quality of life for patients.

In our most recent update from ENVISION, which we shared earlier this week, we announced a 24-month duration of response of 72.2% by Kaplan-Meier estimate for patients who achieved a complete response of 3 months after the first installation of ZUSDURI. The sustained response observed offers real value to both patients and practices, allowing management of recurrence with greater confidence and extending the time between recurrences.

Importantly, the median duration of response has not been reached and the event rate has not accelerated and remained steady over time. According to the published literature, the median duration of response for TURBT in this population is approximately 6 to 9 months with a substantial proportion of patients recurring within the first year.

These results are further supported by the 5-year follow-up data from Phase II OPTIMA II study in both newly diagnosed and recurrent disease, which was published in the Journal of Clinical Genitourinary Cancer this past June. In that trial, of the 41 patients who achieved a complete response, the median duration of response was approximately 2 years by Kaplan-Meier estimate.

Among the 17 patients who entered the 5-year extension study, the median duration of response was 3.5 years. These data contribute to the growing and consistent body of evidence demonstrating that ZUSDURI is not only effective in achieving a complete response, but also offers durable disease control over time. We are very optimistic about the emerging long-term durability profile of ZUSDURI.

I'll now briefly update you on the clinical pipeline. UGN-301 is our investigational anti-CTLA4 antibody delivered via RTGel. It is currently being evaluated in the Phase I trial both as monotherapy and in combination with UGN-201, our TLR7 agonist, and with gemcitabine. We shared the latest data at the AUA meeting in April.

And the safety profile continues to be favorable across both the monotherapy and combination arms. We observed clinical responses in both monotherapy and combination arms with follow-up on the combination arms ongoing to evaluate the durability of response. We expect to share updated data later this year, and we'll use those results to guide a potential decision to move into Phase II development.

As Liz mentioned earlier, we're also advancing our next-generation formulations of ZUSDURI and JELMYTO. The Phase III UTOPIA trial is evaluating UGN-103, the successor to ZUSDURI, in patients with recurrent low-grade intermediate risk disease and has completed enrollment. This study is modeled closely on ENVISION. Efficacy will be measured by the complete response rate at 3 months with follow-up focused on assessing durability.

We expect top line complete response data by the end of this year, and we plan to share those results with the FDA to help inform the regulatory path forward. We are also taking a similar approach with UGN-104, our next-generation formulation of JELMYTO. We recently initiated a single-arm Phase III trial and patient screening is underway. UGN-501, our recently acquired next-generation oncolytic virus candidate, is progressing through IND-enabling studies, with a Phase I trial anticipated to begin next year.

I will now turn the call over to David for the commercial update.

Thank you, Mark. As my colleagues have shared, we believe ZUSDURI represents a true shift in how recurrent low-grade intermediate risk non-muscle invasive bladder cancer is treated. Our focus now is on ensuring that all appropriate patients have access to ZUSDURI in an accelerated and successful launch.

We have completed the expansion of our sales force, having increased the total number of reps from 50 to 82. With this footprint, we believe we are well positioned to reach the 8,500 health care providers who treat approximately 90% of the addressable patient population.

We view the launch in 2 distinct phases. The first phase covers the period from July through the end of this year. The second begins on January 1, 2026, when we expect to receive a permanent product-specific J-code. That milestone will be an important catalyst for broadening adoption, particularly in the community setting, where reimbursement logistics play a critical role in treatment decisions.

During the initial phase, our commercial priorities fall into 3 areas: engaging with health care providers, activating treatment sites and advancing market access. First, our field team is focused on building awareness, establishing clinical conviction and ensuring providers and staff are educated on how ZUSDURI will benefit appropriate patients. Even at this early stage, we are encouraged by the level of interest we're seeing. Awareness around ZUSDURI is strong and health care providers are eager to learn about the profile of ZUSDURI and engage on appropriate patient types.

Customer questions focus on the clinical, operational and financial considerations to begin treating with ZUSDURI. We are initially focused on a group of roughly 2,000 physicians out of our total 8,500 target universe, whom we've identified as likely early adopters. These are physicians who have demonstrated a willingness to introduce new therapies during a miscellaneous J-code period.

Our goal is to engage with the majority of accounts within the first 6 to 8 weeks of launch, and we are making strong progress toward that target. Our discussions with physicians are focused on identifying patients who stand to benefit most from treatment with ZUSDURI. This typically involves those with multiple prior recurrences and a history of repeated TURBTs, patients experiencing early recurrences after surgery and patients who may be poor surgical candidates due to comorbidities or other risk factors.

The second area of focus is site activation. We are working closely with practices and hospitals to ensure operational readiness. This includes everything from distributor onboarding to clinical training and pharmacy processes.

As we have noted previously, many providers prefer to initiate the use of new therapies like ZUSDURI in the hospital outpatient setting where hospital pharmacy budgets are often managed at separate cost centers. We are supporting this process, including working with P&T committees to ensure formulary placement as quickly as possible.

On the market access front, our team is actively engaged with major payers nationwide. At this stage, we have secured open access for approximately 84% of covered lives. These efforts are central to the launch and reflect our commitment to ensuring patients can access ZUSDURI without unnecessary administrative or financial barriers.

Looking ahead to 2026, the assignment of a permanent J-code should significantly simplify the reimbursement process. At that point, we intend to broaden our commercial focus to include a broader segment of the urology market, including many more community-based practices.

Turning to JELMYTO. We continue to drive strong year-over-year unit growth, which reflects growing comfort and conviction among urologists. We see steady growth in both the number of sites of care and the number of new prescribers, and we are encouraged by the positive trends in patient identification. The message around durability of response remains central and continues to resonate, and our team is maintaining high-frequency engagement with top-performing accounts to sustain momentum and drive further growth.

I will now turn the call over to Chris Degnan for a financial update.

Thank you, David. As Liz mentioned earlier, JELMYTO net product revenues were $24.2 million for the 3 months ended June 30, 2025, compared with $21.8 million in the same period in 2024. Year-over-year revenue growth of 11% was driven by underlying demand growth of 7% and price favorability as the gross to net rate for JELMYTO has stabilized in recent quarters.

R&D expenses for the second quarter of 2025 were $18.9 million, including noncash share-based compensation expense of $0.4 million. This compares to $15.4 million, including noncash share-based compensation expense of $0.6 million for the same period in 2024. The increase in R&D expenses of $3.5 million was primarily driven by higher manufacturing costs for ZUSDURI and costs associated with the Phase III UTOPIA trial for UGN-103, partially offset by lower clinical trial costs and regulatory expenses in connection with ZUSDURI.

Selling, general and administrative expenses for the second quarter of 2025 were $43.2 million, including noncash share-based compensation expense of $2.3 million. This compares to $30.1 million, including noncash share-based compensation expense of $3 million for the same period in 2024. The year-over-year increase of $13.1 million was primarily driven by ZUSDURI commercial preparation activities as well as an increase in overall commercial costs.

We reported noncash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the second quarter of 2025 compared to $5.8 million in the same period in 2024. Interest expense related to the term loan facility with funds managed by Pharmakon Advisors was $4.1 million in the second quarter of 2025 compared to $3.5 million in the same period in 2024.

The increase was primarily driven by interest expense related to the third tranche of the loan that was funded in September 2024. We do not intend to draw down the fourth and final tranche of $75 million that is available to us at our discretion until August 29, 2025.

Net loss was $49.9 million or $1.05 per basic and diluted share in the second quarter of 2025 compared to a net loss of $33.4 million or $0.82 per basic and diluted share in the same period in 2024. As of June 30, 2025, cash, cash equivalents and marketable securities totaled $161.6 million.

Turning now to guidance. Our full year guidance for JELMYTO remains unchanged. We continue to expect full year 2025 net product revenues from JELMYTO to be in the range of $94 million to $98 million, and this implies year-over-year growth of approximately 8% to 12% over the $87.4 million in demand-driven JELMYTO sales in 2024. This excludes the $3 million in CREATES Act sales reported in 2024.

Guidance on full year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million, including noncash share-based compensation expense of $11 million to $14 million. We anticipate operating expenses to decrease modestly over the remainder of the year, reflecting the impact of several nonrecurring costs incurred during the first half of 2025, partially offset by the sales force expansion in the second half of the year.

These nonrecurring costs totaled approximately $15 million and included expenses related to the acquisition of UGN-501, preparations for the ZUSDURI ODAC, our national launch meeting for ZUSDURI and manufacturing expenses for ZUSDURI, which were accounted for as R&D expense prior to FDA approval.

That concludes our prepared remarks. We are now ready to open the call for questions. Operator?

[Operator Instructions] Our first question comes from Tara Bancroft with TD Cowen.

So I have to ask the obligatory first question on all of our minds. Is there anything that you can offer on metrics you've hit so far for July, like, I mean, script rate, number of active accounts or prescribers that you have, or really anything qualitative, like the perceived level of pent-up demand from those who were maybe waiting to get a TURBT to instead receive ZUSDURI, if any, things like that?

Yes. A great question, Tara. It's Liz. And I'm going to ask David to comment, and then I'll probably add some color as well. So David?

Yes. Thanks for the question. We're really excited by the positive receptivity of not only the health care providers that we have engaged, but also the payer community. As we heard prior to launch, they're very eager for a new treatment option, and they took on the ZUSDURI product profile with great enthusiasm. So we are very pleased with how we've heard about it.

In the stage of the launch, as we said, we're really actively engaging physicians. We're helping them identify sites of care. And importantly, we're also continuing to make sure that market access -- we laid the groundwork for market access so that all the patients have access to the product per label. So anyway, thank you for the question, and we'll be looking forward to sharing more results in the future.

Yes. Tara, look, I'll give you a little bit more color on that. One, we're not going to give metrics at this point. I'm sure everybody would love to have them, but it's still very early for us. What I will tell you is that we've all been spending a lot of time out in the field and talking to doctors. And to David's point, there's a lot of excitement.

And what you hear from doctors is they all have patients. And I want to sort of put a note on patients, because when we launched JELMYTO, it's like I have a patient. And when we talk to doctors today, they have several patients. The biggest hurdle, frankly, is reimbursement, which we knew that. I can tell you that I went to an event last week with a lot of community practices and doctors and the first thing they say is, as soon as you get a permanent J-code -- soon as you get a permanent J-code, I've got patients waiting.

We don't and we've always said there would not be a bolus of patients. But again, what I can tell you is that our PEFs are coming in, patient enrollment forms. So the top of the funnel, we're very happy with where we're going there. And the team, as David said, is working on the sites of care, pulling those through and dosing -- really getting patients dosed.

So I would say at this point, we're very optimistic. We feel really good about where we are. We think the consensus, as we said for the year, we are still aligned with that and have the opportunity to see some real uptake over the next few months. I do think David commented this in the prepared remarks that you will see an acceleration after the first of the year when we have the J-code. But we have hospitals, we have institutions and we've got some large practices that are all willing to write. So it's not like no one is willing to take -- to do it during the miscellaneous code. But you do see a big difference in sort of attitude kind of before and after.

But the good news is, is that all of the metrics, the feedback we're getting –- I have not talked to one doctor who said, no, I don't see a role for this. And none of them, frankly, that say they're going to really limit it. So again, a lot of excitement around using this in multiple patients in their practice. So hopefully, that extra color helps without giving very specific numbers for you.

But David also mentioned sites of care. We have set up a lot of sites of care, and we're on track with where we need to be in the number of sites of care that we already have set up so far to deliver what we've stated we would deliver for the year. So hopefully, that helps.

Our next question comes from Michael Schmidt with Guggenheim.

Perhaps a follow-up just on the early launch. Yes, we've certainly had some very positive feedback from urologists as well that we spoke with in terms of intent to prescribe the therapy. But just curious what you're seeing so far around the reimbursement process early on using the miscellaneous codes. Just curious if you could comment perhaps how much time it takes in terms of intent to prescribe until sort of conversion to paid prescription? Or anything along those lines would be helpful. And then I had a follow-up.

Yes, sure. Go ahead, David.

Yes. I'll just comment on the initial process in terms of educating accounts. So as we discussed in our prepared remarks, we are really focused on a group of around 2,000 providers that have demonstrated a willingness to adopt product during this particular period. And so that's pretty much what we're seeing in terms of interest right there.

One of the things we do, which is very similar to what we did with JELMYTO at that launch, is we spend a good amount of time educating them on the actual process for claims and billing and then reimbursement. So we educate them fully on that. So it's white glove service. And with that, they have the reassurance of knowing they've -- when they enroll a patient, they know what that patient's co-pay is going to be, they know what the coverage is going to be, and the office feels more reaffirmed in terms of how that process is going to work.

As you know, with the miscellaneous J-code period, it is a little bit of a different process because it's manual. But what we're seeing so far is that when we engage the practices, they feel assured that what they're doing is setting them up for a positive experience.

But too early to give -- too early -- so we haven't had any "paid claims yet." So it's too early to sort of say how long is it going to take. As we start to see that coming through, we'll be able to give you more color on that. But it's too early to see that.

Right. And then I guess if you were to compare the initial experience of the ZUSDURI launch to your experience with JELMYTO 5 years ago, I guess, how much commercial synergies are there in place today given your commercial footprint around the JELMYTO product? And any key learnings that -- as you launch ZUSDURI essentially into a very similar market here?

Yes. Since Mark and I were the only 2 people here when we launched JELMYTO, I'll give you some comment and ask Mark to add anything. I think the –- it's similar in a lot of ways in the sense of what you have to deal with, with the J-code, what you have to deal with reimbursement, what you have to deal with identifying patients, and what you have to deal with, frankly, for an office to get set up, set up with the distributor.

The good news is, obviously, a lot of these offices are already set up. So all we have to do is add in ZUSDURI where they already were. So there is a little bit of paperwork that happens there. Absolutely, some of the first physicians that we see that are writing for ZUSDURI are writers of JELMYTO, which makes a lot of sense. And I think the -- what we also are seeing is that for the most part, people were really happy with the support that we gave them with JELMYTO and are happy with the support that they're getting.

Again, the physicians that I've personally interacted with have commented about particularly our reimbursement team because that's the #1 thing right now and how good they are, how knowledgeable they are, how helpful they are. And then I'm going to let Mark talk about the numbers because I think that's a big, big difference between what you -- what we heard when we launched JELMYTO versus what we're hearing now. So Mark?

Yes. Thanks, Liz. So it's, I think, obvious to many on the call that we're dealing with a completely different demographic, so to speak, a demographic opportunity. Upper tract urothelial carcinoma, the target of JELMYTO use, is a very small population of patients. And on average, most practicing urologists will see 1 or 2 patients a year. So it's hard to find the patients and it's hard to find individuals to treat with JELMYTO, which I think explains a lot of the experience of why the JELMYTO ramp has been what it has been. That's very different than what we're dealing with, with the ZUSDURI launch.

There are lots of patients who qualify by the label alone for the use of this drug, and physicians are exceedingly familiar with this population of patients. These are people we're seeing in the office on a very regular basis. So I do think although -- as Liz pointed out, many of the sort of mechanical issues related to bringing the drug into the practice are similar and will be familiar to people who have used JELMYTO. The opportunity, the ease of administration, the fact that this can be given in an office with essentially minimal physician involvement, this can be given by a nurse will really change the way the ZUSDURI experience looks compared to our experience previously with the JELMYTO launch.

Let's just squeeze one more in, and this one is on UGN-103. And so now with the UTOPIA study fully enrolled, I was just curious if you had the chance to have any additional discussions with the regulators in terms of -- sort of coming off of the panel earlier this year in terms of whether the study is, in fact, supportive of potential approval? And from a clinical perspective, is the goal to essentially reproduce the ENVISION data? Or is there opportunity to differentiate clinically with 103?

Yes. No, a great question. We have not interacted. It's -- we don't have enough data yet. So we're waiting on additional data before we interact with the FDA. But we will absolutely do that and have feedback for you prior to the end of this year. So I think that's the timing on that. The goal is to replicate. And we actually purposely did that because what we didn't want to do is introduce any potential issues, right, that would muddy the waters as far as the data is concerned. So we tried to replicate almost exactly the ENVISION study.

So there -- unfortunately, there's no differentiation. But fortunately, what we're doing is trying not to introduce any biases. Our expectation is that the FDA will accept the study as they had previously communicated, mainly because this is a new formulation. And they actually have UGN-102, ZUSDURI, as a historical control now. So we do plan to interact again with them. We'll have feedback for you before the end of the year. But that's our expectation and that's what we're moving forward with.

Having said that, we and ourselves want to continue to expand the use of UGN-103. So we are in the planning of additional life cycle management studies that we will start fairly quickly on UGN-103 regardless of the FDA feedback. But we have other studies that we want to do in other populations, and we'll be starting those as quickly as possible.

Our next question comes from Leland Gershell with Oppenheimer.

A few from us. With respect to the first phase of the launch pre the J-code assignment, I'm wondering, as you're going after those 2,000 docs you've identified as early adopters, can you share what -- how those break down with respect to community versus academic docs?

Should we think of the academic -- those who practice in an academic setting as maybe having easier access to the medication? Is the miscellaneous J-code easier in the hospital setting or through that process? Is there a P&T committee dynamic that we should consider for ZUSDURI in the hospital setting? If you could share, yes, any color around that as we think about 2025 sales before the J-code kicks in.

Yes, absolutely. David?

Yes. The majority of that 2,000 physician, I'll say, early adopter list that we've identified reside in the community, and there are some in institutional settings. And as you know, some have privileges in hospitals as well. So when we think about them gaining access to ZUSDURI, it is -- there's a spectrum. In private practice, as we've mentioned, there's historically some hesitation there. And so what we try to do is help them identify a site of care where they can administer ZUSDURI for the first time and gain experience. And that often is in a hospital outpatient setting.

If it is a specific hospital account, I think that process varies. But generally speaking, you'll see that they have formal P&T reviews. And so one of the things we did immediately upon launch was engaged major accounts so that we could begin working with them to provide the clinical, the operational and financial information to support a successful P&T review.

Okay. Great. And then just another question with respect to the UTOPIA trial. Do you think the FDA would ask for longer durability data or anything that may be incremental to what was shown with ENVISION? Or do you think it truly would be kind of a replicate of the ENVISION data set that could get 103 approved?

Yes, we are expecting it to be similar to what we presented for ENVISION. We're going to talk to the FDA about their expectations. But our expectation is that it would be -- it would mirror similar types of requirements as ENVISION, namely concentrating on CR with some reasonable amount of durability data. And that would obviously be something that we have to talk to the agency about.

Our next question comes from Raghuram Selvaraju with H.C. Wainwright & Company.

Congratulations on all the progress so far. I wanted to ask, first of all, about clarification of a couple of commercial things. Firstly, you alluded to once the formal J-code designation is complete at the beginning of next year that there would be outreach facilitated by this to a broader group of prescribers. Can you maybe quantify for us how many more prescribers are likely to be targetable beyond the initial 2,000?

And then also, I wanted to ask if you are seeing any evidence that the commercial availability of ZUSDURI and the increased visibility of the company overall is having any potential beneficial spillover effects on JELMYTO itself? And if you're seeing any noteworthy reacceleration of momentum in JELMYTO because ZUSDURI is now available?

Yes. David?

So on your question around how we're going to engage the total universe. So as we said, we are focused on the 2,000 that we think are very important to the early stages of a launch. It doesn't mean that we won't see others in the universe if they're in the same office. But broadly speaking, as we turn the corner into 2026, we will expand our efforts beyond that 2,000 and we'll begin very rapidly then expanding our reach to a greater number of them.

So I would say by the middle of next year, we're going to see -- we're going to be broadly engaging everyone in that total universe. And keep in mind that universe also includes -- in each office, there's physician assistants, there's nurses. So our efforts go well beyond just the HCP.

With regard to your question on JELMYTO, it's too early to say that. But what I can tell you what we've observed so far is that, as Liz mentioned, those who have used JELMYTO definitely understand the technology behind ZUSDURI. And what I would say, as we move forward in time, as we penetrate the overall market for low-grade intermediate risk non-muscle invasive bladder cancer and ZUSDURI, we will see that, that increased reach and frequency through the universe will support the continued steady growth of JELMYTO.

Great. And then just one follow-up with respect to UGN-103. I was wondering if at this juncture, you have any reason to believe that because of the characteristics of the new formulation, 103 might have advantages in safety, tolerability or ease of administration relative to ZUSDURI itself?

The answer is we don't, and we didn't expect any real changes. For the audience, just to remind you, the principal issues related to this formulation relate to solubility, ease of reconstitution related to a change in the excipients of the preparation. But we don't expect a change in terms of the clinical profile, and it's premature for us to talk further about that, and we will be happy to share those data when we have them later in the year.

[Operator Instructions] Our next question comes from Paul Choi with Goldman Sachs.

I also want to follow up on UTOPIA and maybe ask, is there anything in terms of either the data or product profile that you might call out that would allow you to address additional segments of the low-grade intermediate risk population that you feel like you can't currently tap with ZUSDURI? And just sort of would there be any sort of incremental subset of patients that might be better candidates for that product?

And my second question on ZUSDURI is just, I guess, as you think about sort of the product procedural flow in doctors' offices, can you maybe just comment on how you're thinking about nonphysicians such as licensed nurses practitioners as a percentage of the mix? And are there other requirements for non-urologists to use the product?

Go ahead, Mark. Do you want to answer the UTOPIA question? Are there any...

Yes, sure. So the answer to the first question is no. As Liz mentioned, we are really formatting the evaluation of 103 in the UTOPIA trial in exactly the same manner as we did ZUSDURI and ENVISION. So it would be applicable to the same population of patients, and we wouldn't expect a change in terms of the target population it would be used in initially.

What you're anticipating, I think, in your question is the possibility of us doing additional clinical trials, which is something we have to talk about and think about and Liz will ultimately make a decision about. But currently, the plan is for the same group of patients with that drug when it becomes available and is approved.

Yes. But as I mentioned earlier, we absolutely expect to expand UGN-103 into other patient populations, but not because it's different than ZUSDURI, right, from a clinical perspective, but just because we would be doing that with UGN-102. So it makes more sense for us to be doing that with UGN-103, assuming the data is very similar as we start to -- as the data starts to play out. But that's our expectation. So we will expand absolutely into other patient populations, but not really driven by any differences we see.

David, you want to answer the question around ZUSDURI?

Yes. So on the question of ZUSDURI and actually who might be administering this in the office, what we're hearing early on is that, obviously, the physician will want to be understanding the entire process, the ordering all the way through administration. But we do expect and we've heard this consistently that as practices get more experience, that it will really fall on the shoulders of someone specifically who does intravesical therapies, likely a nurse. And so that's pretty much what we're hearing right now, consistent with what we learned before launch.

And we are engaging all people in the practice, right, everybody from physicians to your PAs to your -- the reimbursement team. So from that perspective, included in the 8,500 targets are other targets outside of physicians. So we'll continue to do that. This is a full –- a comprehensive account sell. It needs to be. But in the beginning, clearly, the physicians' conviction around wanting to use it is going to drive the early adoption.

Our next question comes from Aydin Huseynov with Ladenburg.

Congrats on the quarter. A good couple of questions I want to ask. So first, I wanted to ask that if there were not questions about permanent J-code, if we didn't have issues with J-code this year, permanent J-code this year, how many patients do you think it would be possible for you to dose in 2025? So the reason I'm asking because ENVISION trial enrolled very quickly, I think, 220 patients, 10 months across 90 sites. I was trying to understand if we did not have reimbursement issues at this point, so how many patients would it be possible to dose in 2025?

Yes. Look, that's a great question, not one that we're going to speculate on. But suffice to say that absolutely it's a significant number of patients. As I mentioned earlier, the #1 barrier right now is reimbursement. It's not around the desire for clinical use. And that's a good thing. That's a really good thing.

I mean, rarely do you roll out where there's not question -- more questions around the clinical data, the clinical use, the patient identification, and we're not hearing that. The only -- again, in all the conversations I've had, it's only been around reimbursement. So that's actually a good thing, because we can solve that, right?

It takes time to solve that. But once we start getting explanation of benefits, EOVs out there, once they start to see what we're hearing from a lot of the practices, is, okay, I'll try it on one patient. They typically want it to be a Medicare fee-for-service patient, because that's kind of the one that they feel most confident about. And then once they get that experience and see a positive reimbursement, then they're more willing to expand beyond to other patients.

But I think, again, without speculating on the number, it would be significantly more. There's no doubt about it. And I think the good news is when you're out there talking to doctors, that's the question. It's really around reimbursement and not around the clinical usage or utility or need for this drug. And I think that's a very good place for us to be.

When do you think you'd be able to provide short-term and long-term guidance for ZUSDURI? And just trying to -- I know that we're talking about the story being overall targeting $5 billion market, but we're also trying to understand what would be the peak sales. Just wanted to understand the level of comfort to provide a both short-term and long-term guidance for the drug.

Yes. Aydin, this is Chris. I mean I think we've been pretty clear in terms of peak potential. We view ZUSDURI as over $1 billion opportunity by itself. In terms of providing more short-term guidance, I think we'll get through the early initial launch phase this year and look to potentially provide guidance for 2026.

This concludes the question-and-answer session. I would now like to turn it back to Liz Barrett for closing remarks.

Yes. I just want to take an opportunity to say thank you to everybody. Thanks for hanging in there with us over the years. It's an exciting time for us. We're still in the early days, but things are looking great and we're very excited about kind of where we are and where we head to be. And we'll keep you guys posted as things play out. So thanks a lot. We appreciate it.

Operator, you can disconnect at this moment. Thank you.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Good day, and thank you for standing by. Welcome to the UroGen Pharma ZUSDURI Approval Investor Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mr. Perrone, Head of Investor Relations. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's ZUSDURI Approval Conference Call. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Urogen disclaims any obligation to update these statements. I'll now turn the call over to Liz. Liz? .

Thanks, Vincent, and thanks, everybody, for joining today. I do want to take a moment to do 2 things. One, thank everybody on the call and all of our investors that have had confidence in us over the years and have stuck with us and even through this, I would say, roller coaster ride over the last few weeks. So just want to say thank you. It is very much appreciated. The outreach has just been phenomenal even after the ODAC before the approval and obviously, since the approval. The second thing is I want to say these things don't happen by accident.

And I want to really send a sincere thanks to my team at UroGen, the team worked extremely hard. We conducted very, very good studies over the years. The data is phenomenal, as you guys all know, never been seen in this patient population before. I think our filing was very strong. I think the presentations at the ODAC were very strong. And importantly, the work that we did post ODAC and prior to approval. And so I'm very, very thrilled to be able to be here with you today in this remarkable event and very much a game changer, not just for us, but for patients as well.

I'm sure you guys have lots of questions. We'll get to those. I do want to just also thank the FDA, frankly. I think that if I learned anything through this process, what I learned is that I believe that we have a shared goal even though we may look at things very differently. I think at the end of the day, we both want it in the best interest of patients. I think we learned a lot during the situation and not necessarily unanticipated. One of the things that we always knew as being in the ODAC division, oncology division with really a product in a disease that is treated by urologists would be challenging.

On the other hand, what's nice about the oncology division is they understand cancer and they understand the impact that cancer has on patients. So I do want to give a shout out to the FDA unlike, I think, what's been said in the media in the last few months, the FDA is not in pharmaceutical company's pockets. I mean they are very independent. -- they're very rigorous, and they've definitely put us through it. And -- but I think that given the ODAC, and we can obviously talk more about that, we really felt like the way that the ODAC was panned out that we kind of were set up with the question around the randomized controlled trials.

And I think they felt that way, too. I mean, I can't speak for them. They never said that. but we know that it definitely completed the issue and Mark did a nice job in our meetings with them talking about that. I think the other thing was really the strong and strength of urologists in the voice of the urologist at these meetings also had a big impact. So we will -- we can talk more about it, but I don't want to spend too much time focused on the past. We want to really focus on the future. And I will tell you, and we have David here today. As you heard, we expect to be able to ship product in a couple of weeks.

And there is product in the U.S. already, and we obviously have to do the labeling and all of that, but we put ourselves in a position where within a couple of weeks, we could be ready to go. So the plan right now is the July 1 launch David can get in more detail with you, but the expansion was we had sent out contingent offers and those offers will have been given out yesterday as soon as we got the approval, and so we'll have another 30-plus reps joining the organization. until that time. Obviously, our current team has been trained and ready to go. And like I said, David can talk more about our launch readiness in a moment.

We will file for a unique J-code by the July 1 deadline, which should give us the permanent J-code by January 1, which is what we expect. The list price per vial is going to be $21,500, -- we believe that's the right balance and the right value for the therapy. -- especially given the unmet need, but also importantly, the data that we've shared so far. I think, again, David can talk more about it, but we've identified early adopters. A lot of those are amino users, but also accounts that we believe would not be -- are willing to write for the drug without a permanent J code.

And so we do have both institutions and community practices that are very comfortable doing that. And so the team has identified what they believe will be the accounts to go after in the beginning. But that doesn't mean we won't be calling on everybody. It just really means that we'll put a focus on those accounts that we know are there and ready to go. Lastly and obviously, Chris can talk more about this. But as March 31, we reported $200 million in cash, which we believe is sufficient to support the commercial launch of UGN-102 and provide cash runway through profitability.

While we also focus on our near term, we're also committed to driving a long-term sustainable growth company. So we'll continue to evaluate opportunities going forward and capital needs that would support that vision and expect to hear more about that as we go forward. I think we've talked about it before. We've got 301. We've got 201, and now we have 501 in addition to a lot of life cycle trials that we want to do with UGN-103 as the next generation as we move into high-grade disease with UGN-103 as well as maybe even we have to think about, but we're considering other patient populations in the low-grade intermediate risk patients. So Again, thank you, everybody, for joining us today, and we can open it up for questions.

[Operator Instructions] Our first question comes from the line of Tara Bancroft with TD Cowen.

I just want to offer my sincere congratulations. This is a wonderful outcome congrats. So I think for me, my question is going to be about expectations both for cadence and magnitude, especially with the focus on potentially with institutional and hospital settings for the miscellaneous J code. And if there's any potential maybe for a bolus of patients due to pent-up demand for a therapy or anything Yes, just expectations for the initial launch?

Yes, in tariff, thank you. You've been a great supporter. Really appreciate it and appreciate your comments over the last few weeks as well as your wishes. So thank you so much for the support. I'm going to turn it over to David. I will say before I do, we do not expect a bolus of patients we can talk to you why. But David, do you want to just talk about the expectation around cadence?

Yes, absolutely. Thanks for the question. Yes. I'll start with the question around the bolus. We don't anticipate a bolus. But in talking to practices and urologists through the last period of 6 months as they've been tracking our NDA. They do know that these patients exist. But just given the standard of care, there are options today, which they undergo, as you know, with TURBT and travel chemo -- and so while they're really excited to have a new option, we just don't see a bolus being present right now, but they will begin to identify patients as we engage in promotion -- in terms of the cadence and magnitude, our focus at the launch is really to establish a very strong beachhead.

So as Liz mentioned, we are going to focus on a cohort of -- or I'll say, extra focus on a cohort of urologists who have demonstrated a willingness to adopt new therapies, particularly in the early parts of launch. So many of those are JELMYTO writers already, and we we'll focus on a specific group of not only urologists, but also their affiliated types of care. So we can enable them to get clinical experience with the story whether it's in their clinical or their community practice or in an affiliated hospital outpatient setting.

And then as we turn the corner into 2016, we'll expect to expand our penetration as well as the number of sites of care that we're interacting with. So we'll consider it a very focused start, but then broadening over time. and that will be very consistent with how we've learned through our research and how to engage the neurologists. Thanks for the question.

Our next question comes from the line of Michael Schmidt with Guggenheim.

Also, I want to congratulate you on this great, great achievement and the FDA approval after a very interesting ODAC discussion, obviously. So a couple of more questions just around the commercial opportunity. So you mentioned the list price earlier -- could you just comment on perhaps what proportion of the market is expected to be Medicare driven and how we should think about net price in that market segment.

And then the other question I had is, I think you've talked about this 59,000 patient opportunity per year in the U.S. And yes, maybe talk about what fraction of that opportunity, the initial commercial effort is addressing perhaps in the coming years and how we should think about the trajectory given the size of the opportunity? And then I'll leave that have a couple of follow-up.

Okay. Great. Thank you, and thanks again, again for the support. Chris, I'm going to ask you just to talk about the net price assumptions and then turn it over to David to talk -- to answer the other questions, I'll chime in if we miss anything. So Chris? .

Sure. Sure. So Michael, I would think about story net price similar to what we're realizing for JELMYTO may be slightly better. So just a reminder, JELMYTO, we're realizing about an average 75% GTN. David? .

Yes. Okay. Michael, yes, in terms of the patient population, I think if we look at the overall payer mix, we do expect Medicare to be a majority. So 65%, 70% of the population is expected to be Medicare, very consistent with the patient demographic. And to your point about the overall addressable population, Well, you're right. When you look at the world is about 59,000 patients who are recurring every year. And the way we think about that is, obviously, there's going to be very low hanging fruit, which is not really going to be the focus of our messaging we're going to talk around recurrence because that really is the problem that these urologists are trying to solve.

So we'll be identifying patients along with the practices. So we'll look at early recurrence. We'll help them identify frequent curves. And then, of course, as I mentioned, the low-hanging fruit that they're already thinking about is going to be the surgically ineligible patients -- so that's a group that's often you hear about is frail and they really just can't undergo another anesthesia. So physicians have well understood that. We heard that from the research. But -- our main goal in terms of promotional messaging is to leverage the compelling data that we have from our Phase III trial to help them identify the early recurs, the frequent recurs. When you add all that up together, that's probably 1/3 of the addressable population right off the bat. Thanks for the question.

Okay. Super helpful context. And I just had one more sort of a clinical type question. So coming out of the ODAC meeting, and as we think about the UGN-103 and the development path for that product. Do you plan any changes to the trial design or the market strategy? Or are you sticking with what you've started so far?

Yes. I think that, that's something that we are working on, and we will be in contact with the FDA to confirm what the expectation and needs are for G10 we don't have any additional information at this point. I can tell you that for our purposes, internally, we are well prepared and plan to do more studies with UGN-103 anyway regardless of what the FDA says. But the strategy hasn't changed, and we still believe that no matter what we can actually continue to launch UGN-103, have the time to switch the market before our patent expiry.

So the strategy hasn't changed at all. And -- but we have not had the opportunity to talk -- to discuss that any other changes with the FDA. And look, I also failed to mention in the intro as you guys saw with the label, we got the full recurrent low-grade non-muscle -- non-muscle basin bladder cancer. And there weren't any randomized controlled studies as any post-marketing commitment. And I think part of that is driven by the fact that it's very difficult to do one. We kind of got off track right in the conversation at the ODAC, but there were reasons very, very good reasons why we did not continue with the randomized control trial.

Unfortunately, those regions still exist. And I think the other thing that was recognized was we can do an adjuvant study. Those are easy to do. That's what our other companies are doing in this space. But then you have to do a surgery so with an adjuvant. So it's going to be the sort of balance between randomized controlled trials. But now the 102 is out there, there's something to compare to. So anyway, I just bring that up in the sense of as we think about what we do in the future, some of the challenges that we had have not gone away. Those are still conversations we need to have with the FDA.

Great. And yes, congrats again to the approval here.

Thank you. Appreciate it. .

Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright.

And once again, congratulations. I think this is a landmark achievement not only for the company but also for non-muscle invasive bladder cancer patients who historically have really not had much in the way of pharmacotherapy options. I wanted to, first of all, drill down on the number of vials you expect on average to be used per patient. And if you can comment at this juncture on -- if you look at an annualized basis, approximately how many treatments might be administered in order to address the recurrence issue? .

Yes. Okay. Thanks, Ram, and you've been here from the beginning. So I just want to put a special shout out for you. So I appreciate it. I'll turn it over to David to answer the question, I'll chime in if there's any additional information. David?

Yes, thanks for the question. In terms of the number of vials per patient, we expect that to be somewhere between 5% and 6% when you look at it across the totality of the business. that somewhat mirrors JELMYTO. That's our working assumption right now. But given the ease of administration and the overall side effect profile, one of the things we do anticipate here is that when physicians prescribed the story will, for the most part, expect them to see the full course of therapy of 6 doses over 6 weeks. And Ram, could you remind me the second part of your question was the number of treatments? .

Number of treatments on an annualized basis on average that you anticipate for a typical patient who's needing to use this product to manage recurrence risk.

So my perspective is that it's a little early to tell given the compelling data that was generated in ENVISION, the expectation that we will have going in is that once a patient is treated -- they're going to be monitored with their physician in typical form. So right now, I wouldn't expect personally to see anything that's very different than our ENVISION trial results. But I think we'll have to just learn as we go through the market and get customer feedback. But I think for the most part, they are very, very enthused by the overall clinical trial results. So that's the way they're thinking about treating the treating now.

Ram, let me just clarify. Are you just asking like within a given year, will a patient be able to get all 6? Obviously -- is that what you're asking? .

No, no. I understand that in an individual treatment cycle, you're looking at the administration of 5 or 6 vials worth of product. But I think ultimately, if you look at the ENVISION trial results. Clearly, after a patient has been treated with UGN-102 once, one would expect them to remain recurrence free for an extended period of time, right?

Correct. Correct. Yes. So are you asking would patients get retreated in a year?

Yes. What proportion of patients you might expect to be retreated in a year?

Yes. I mean, very few, right? To your point, if you look at the data, and we haven't reached our median yet, but if you look at the data, the expectation is that most patients will be out a couple of years before needing another round or whether it's -- obviously, we don't -- we will be -- that's one of the things that we'll be wanting to answer is retreatment and how patients do with retreatment. We will expect that we'll see some retreatment. We see it with JELMYTO there's no reason that assuming that they get a good response, they wouldn't, but I would not assume that it would be within a year. So I think it's a good question. So sorry for the confusion. I wasn't really sure what you're asking, but I think -- hopefully, that's helpful. .

That's very helpful. And then just 2 other very quick ones, if I may. Firstly, you talked about the extent of the magnitude of the sales force expansion. I just wanted to get some clarity on if you feel comfortable that, that level of magnitude of sales force expansion would enable you to appropriately target at least that initial 1/3 of potentially eligible patients that you consider to be the lowest hanging fruit. And so in point of fact, with that level of sales force staffing, you feel reasonably confident in being able to fully penetrate the part of the market that is likely to be most accessible .

David, do you want to answer that question? .

Yes. We're very confident that the overall size of our field organization is more than capable of addressing that particular segment and not only that, but also the total population. But as was asked in the previous question, it's really a phased approach. So we're going to focus on an initial group and then we'll broaden our reach over time and turning into 2026, the real -- the HCP penetration will increase even further. But whether it's the sales rep or the team that supports some like the nurses and the reimbursement managers, we're very well prepared. We know who those early adopter cohorts are and very confident in our ability to address them in this initial stage.

Yes. The only thing I'll add, Ram, is that is the -- we've sized it for the entire market, not just for the initial rate. So -- and actually, we had added more than what the initial evaluation should suggest it. And that's because we know that these are high-touch cells. We know that we need people in there. And so because of that, we actually added more reps -- but that doesn't mean we won't add more if we feel like we need to going forward. But at this point in time, we feel very good, as David said, very good about where we are, not just for the initial stage, but for -- to be able to reach all of the patient population, I think we're reaching like 85% to 90% of the patient population with our sales team.

And then just very quickly, I wanted to ask you folks about 1 aspect that came up during the ODAC discussion, which was this question around how many TURBT procedures are likely to be avoidable in the context of deployment of UGN-102. And I just wanted to ask if you in your discussions with the prescribers out there to whatever extent you've had those discussions, both leading up to and after the ODAC meeting. to what extent there is a prevailing view that one might only be able to say that the initial TURBT might be avoidable because this was a point that was raised during the ODAC meeting.

Personally, I don't think that this is really supported by the data available. I think the data available, obviously, provides ample evidence of durability and indicates very strongly that multiple TURBT procedures can be avoided. But I just wanted to ask if this alternate view has in any way arisen in your discussions with potential prescribers?

Yes. I'll answer that. No, it has. And I'm going to ask Mark to just comment on that discussion at the ODAC and why it was a premature discussion. So Mark, do you want to just talk about that? .

Yes, sure. Thanks, Ram. So I think as Liz has been alluding to, what got missed in the ODAC, I believe, and I think to some extent, this is because of who we were talking to, largely nonspecialists with no familiarity with this operational disease. The importance of missing or skipping that first TURBT is huge. That is an operation that is avoiding in all -- in virtually all of the patients who received UGN-102 in the trial. Remember, the complete response rate was in excess of almost 80%. So you can say charitably that only 20% people ended up having to have an operation and the durability to date and we haven't reached the median shows that the vast majority of these people still don't have to have an operation 18 months after that initial intervention. .

So no, I don't think that is going to be a talking point for prescribers. In fact, quite the opposite, I think urologists, I'm speaking for myself included, will be being able to avoid that first TURBT as very advantageous for many patients. And then there obviously is going to be the very beneficial impact of the long durability so far demonstrated by UGN-102 in the context of treating this patient population, that will also be seen as a benefit. So I guess the short answer is No. I think we have to flip it around and say, look at the benefit of skipping that versus TUR. You missed the first TUR. And so far, long term, looks like you're not going to need 1 for a long time afterwards in the population we studied, those patients, if they had a TUR as their first therapy would have needed another TUR within about a year.

Yes. And I think that's important. The durability point is what's important, right? And we didn't -- we hadn't finished our durability. So you're looking at data the ODAC that was premature. And we only have the data up until a certain period of time. So I think that, that was a discussion that was again, unfortunate, but a lack of understanding of the disease. So thanks, Ram, for the questions.

Our next question comes from the line of Paul Choi of Goldman Sachs.

And congratulations to you, Liz and the team. very great positive outcome and in particular on your leadership or keeping the faith here. My first question is regardless of the commercial strategy and just how you're thinking about potentially pivoting or expanding following the establishment of a J-code? Just any color there would be helpful. .

And then secondly, for modeling purposes, just with regard to the capital structure. Is it your plan to access the next tranche of debt that's available to you under your financing agreements.

And the last one, just on modeling. Can you maybe remind us of what the royalty rate is associated with the UGN-102 approval that kicks in now that the drug is approved?

Sure. No problem. Thanks, Paul. Appreciate it. I appreciate the kind words. David, can you just answer the question on once we get a J-code anticipated changes? And then Chris, you can answer the financial questions. So first, David.

Yes. Thanks, Paul. As we mentioned at the initial part of the launch, we're going to focus on those prescribers who have already demonstrated a willingness to prescribe in therapies during a miscellaneous J-code period. It doesn't mean that we won't talk to more offices because we'll be continuing to share the clinical data from Envision as part of our promotional message -- and so what it will enable us to do is following receipt of a permanent J-code, we'll be able to help them integrate the story into practice, so they can get their first sitting in their first patients treated.

So it will just be a, I'll call it, a lighter touch with some of the physicians who we know will really expand when there's a miscellaneous J-code. So I'll just say we'll take it in phases, but we absolutely will be touching the vast majority of our overall population over the next 6 months.

Paul, just on the financial question. So one, from a cash runway perspective, the cash to profitability does not contemplate drawing the additional $75 million under our loan agreement with Pharmakon and from a royalty perspective for -- as a story, it's a tiered royalty. So it's a 2.5% royalty for the first $200 million of annual sales, steps down to for the tier between $200 million and $300 million and then it's 0.5% for sales over $300 million. .

Our next question comes from the line of George Farmer with Scotiabank.

And again, my congratulations as well. A couple from me. So the pricing that you arrived at, can you kind of walk us through how you arrived at this thinking about cost associated with TURBT and the treatment burden, et cetera.

And then, Liz, I know you said you don't want to look backwards, but could you give us a little bit of insight on what happened with your interactions with FDA after ODAC?

Yes. From a pricing perspective, let me -- what we do is we do extensive research, extensive research with payers, with physicians, with patients to understand what they view the value is. It's very difficult. There's not a ton of data, and we do have pharmacoeconomic data, obviously, around TURBTs because it ends up being how many this conversation we were having earlier because of the durability of UGN-102, you have to look at it in that perspective.

So we will prospectively be continuing that work -- so it is 1 of the factors, but the main factor is really around payer and physician and patients around the value, how do -- where do they see the value of the medicine as we had initially been speaking earlier, we were talking -- I said -- we said 18,000 to 19,000 and -- but that was before we saw the durability data. And given the strong durability data, we did more research. And again, you want to balance having any restrictions from a payer perspective or any restrictions from a physician perspective.

And I think it's one of the things that we had -- from a pricing standpoint, you've got to think about when you've got these other medicines that will be coming into the low-grade space from the high-grade space. And so in our view, if we had come out with a price that was similar to high-grade, it would limit the adoption. And so it's going to be interesting to sort of see as some of those companies kind of move into this space.

What I will say -- I'm not going to get into a lot of detail, but I think I've shared some of the conversation -- but again, coming out of that, the conversation was really around the -- what happened at the ODAC and the fact that in the beginning that the conversation didn't center around our data, frankly, but the addition of the discussion right before the vote of a randomized controlled trial, one of the things that didn't come out in that in that conversation was the fact -- they kept saying, well, you did a randomized clearly, it's feasible. But what didn't come out was it wasn't about the feasibility of doing a randomized controlled study. It was about agreeing on an endpoint.

And that was not our issue, right? That was not just our issue. That was an issue that the FDA wasn't willing to accept certain endpoints, and we weren't willing to accept certain endpoints, and that's because we were being put in an unfair -- so we had that conversation. We had the conversation about the data. We had the conversation about the agreement that we had with them that when they did tell us that a single arm side it could be the basis for an approval.

So we had all of those conversations with them. We talked about the patient populations. We talked about post-marketing commitments. And I think you see where we ended up because what the conversation came around to is that all of our conversations before the ODAC, clearly, were very thorough, and we had those conversations.

So a lot of the issues, like I said that came up were not new issues, right? These were conversations that we have been having. So it was unfortunate that the full story didn't really come out at the ODAC only the little pieces of it, right? And it didn't paint a very good story from their perspective. But I think you stated there were competition in Mexico like that, that was an unintended consequence. And I think they recognize that and which is why we got an approval and we got an approval on the basis of all of the things that we had discussed with them prior to the ODAC. And again, I think that weighing more heavily weighing and being reliant on the urologists who actually treat these patients.

I think that was a big driver as well. We -- I'm not in their mind, so they will not -- they don't share a lot of information, but I think that, that's kind of where our perspective on it. So I hope that helps everybody like again, it was -- I want to commend our team, we did not any unturned -- we had advocates make it -- we were -- had advocates advocating on our behalf during that time period. And I think our team did a good job of having those conversations with the agency.

Our next question comes from the line of Leland Gershell with Oppenheimer.

My congratulations on what looks like a best case outcome here. Just a question, Liz, on 103. I know you continue to have deliberations with FDA on the requirements for that to be approved. But just wondering, and maybe, Chris, you could add your commentary. With respect to getting towards profitability, should you -- I mean, obviously, you've already begun your kind of Envision Replicate trial for 103 single arm, should you have to change course and run what I guess would be like an Atlas-like study which would involve a lot more patients and probably expense. Could you comment on what impact they may have on your course toward what could be cash flow positive without having to access the capital markets?

Yes. Sure. Chris, do you want to answer that? .

Sure. So Leland when we do our operational planning, we do earmark spend for other development programs. And so we have headroom within our operational plan to fund additional programs such as perhaps a UGN-103 RCT. So those things are on the table with not necessarily impacting our ability to reach profitability. .

Our next question comes from the line of Aydin Huseynov with Ladenburg. .

Congratulations as well for the nice outcome for the approval. A couple of questions from us. So -- are you planning to provide any guidance for the story, for 25 for the longer term? Or -- any -- and if no, when do you expect to start providing annual guidance for the study just like you do it for JELMYTO .

Chris? .

Sure. SP279389043 So we are not planning to provide guidance for 2025 as we go through the launch. I think it's fair to assume likely going into around that time period is where we may start to establish providing guidance for a story similar to JELMYTO.

Okay. I appreciate that. And operational guidance that you provided earlier this year, do you think it might change as you roll out the launch as you probably -- if we plan to expand team or maybe expand the expenses for the marketing. So any changes you would expect throughout the year? .

So no plans to the operational expense guidance that we provided that did contemplate the sales force expansion the approval of the story launched in July. So this all lines up with the guidance we provided at the start of the year. So no change to our financial guidance there. .

Okay. This is helpful. And regarding post-marketing commitments. So I think the FDA asked you for 6 to 3 months follow-up period, annual duration of response updates. So how do you think this update would be sort of influential for urologists to prescribe and for payers essentially to pay? So how important are these updates in your opinion?

Yes. I don't think the updates to the FDA have any basis, but we absolutely believe that the longer follow-up is important to physicians. -- and understanding what the median time duration is durability is. So we absolutely will be sharing that with physicians and we won't be looking at updating the label, but we will provide that information to the FDA, and we will expect to see that information published and we definitely believe that physicians want to see, okay, how long is the durability? What we know now, as you guys have seen, the 18-month durability, we'll be getting we'll be getting the 24-month durability not too distant future. And so all of that will absolutely be important and be a big part of our promotional campaign.

Congrats.

Yes. Thank you so much. Appreciate the support.

Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Liz Barrett for closing remarks.

Yes. Again, everybody, I just want to say a big thank you. We're around if you have further questions. I'm glad that we've finally gotten here, glad for us, but most importantly, important for patients, and we expect to be able to share this and patients have access to this as soon as possible. So again, thank you. We'll keep you updated on any happenings over the next few months. So you may disconnect now, operator. Thank you. .

Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect.