Great. Welcome, everybody. My name is Kelsey Goodwin. I'm one of the analysts here at Piper Sandler. With me, I have the CEO, Liz Barrett, of UroGen Pharma.
Hi.
Thanks for joining us.
Thank you.
Let's kick it off with maybe just a quick one- to two-minute summary of UroGen, where we stand heading into 2026.
Oh, no, great. Look, I'll take a step back for those that are not familiar with our company. Our company was founded on an unmet need by urologists to deliver local medicine to the urothelium in an area where normal medicines, because they're in aqueous solutions, just get urinated out very quickly, so they don't really have an opportunity to work on cancer cells. So the chemists in Israel developed what we call RTGel. It's our innovative technology that is actually called RTGel because it's a reverse thermal gel. Reverse thermal meaning that it's actually liquid when it's cold. It hits the warm temperature of the body, it turns to a gel, and acts as a depot. It delivers medicine over a several-hour time period, gets disintegrated, and voided out very naturally with urine.
So what it does is, because, again, for those not familiar with urothelial cancers, these cancers are really treated locally. So unlike some cancers that are treated more systemically, they're treated locally, and there was this real need for medicines to actually have an opportunity to work in the cell. So that's what our company was built off of. We just got approval for our second drug. Our first drug was for a rare disease in upper tract urothelial carcinoma, and now our most recent approval in low-grade, intermediate-risk non-muscle-invasive bladder cancer.
Perfect. Perfect segue. Let's start with ZUSDURI, first FDA-approved non-surgical option for the intermediate-risk setting of NMIBC. I guess, remind us kind of the disease course and how ZUSDURI solves an unmet need there.
Yeah. What's really interesting about bladder cancer, I should say, in total, is you've got muscle-invasive bladder cancer and non-muscle-invasive bladder cancer. Non-muscle-invasive bladder cancer is the more predominant cancer. But even within non-muscle-invasive bladder cancer, you have lots of segments within that patient population. And oddly enough, low-grade non-muscle-invasive bladder cancer is actually the largest patient population. So when you think about it, what our area of focus is this low-grade intermediate risk. What does it mean? It means that larger tumors, multifocal disease, or a history of recurrence. Therefore it makes the patient become an intermediate-risk patient. With a low-grade cancer, you actually are not likely to die from your disease, and you're not likely to progress. But clearly, you can't have tumors growing in your bladder. And so because of that, it's a history of recurrence.
And so really what you're treating is the recurrence and the sequelae associated, obviously, with having tumors in your bladder. And so today, and previously for the last as many years as I've been around, is a procedure called a TURBT, a transurethral resection of the bladder tumor, where they just go in and scrape out the tumor. And so one, you can only get what you can see. And as we know, there's background disease within the bladder wall that you can't see. And then two, really you can't take out everything. And sometimes there's just areas that you're not able to take out from urothelial cancer. And so therefore, and these patients, as I said, have a history of recurrence. 23% have five or more recurrences. 68% have two or more recurrences. So the average age of diagnosis is 74%.
So you're treating an elderly patient by repetitively bringing them to the operating room with general anesthesia. And so that's why there was this identification of an unmet need and why there's so much of a need for an alternative for that.
Now you're a few months into the commercial launch. We saw the first quarter of sales a few weeks ago. Walk us through what you're seeing and kind of the dynamics of bringing a drug like this to market.
Sure. I first like to talk about the fact that it's not your typical pill or infusion, what everybody's used to. It's a procedure, so I would say the commercialization of it is very similar to a drug-device combination because you actually have to go in and do a procedure, and the drug has to get mixed with the gel, and so there's a lot of operational logistical hurdles to overcome. Urologists are not oncologists, so they're not as used to buy-and-bill drugs. This is a buy-and-bill drug, and so because of that, our team, we have a very cross-functional team that's there to provide service for physicians, so we have operations managers to help with the operational logistics. We have field reimbursement managers.
Reimbursement, being a buy-and-bill drug, very concerned about being able to obviously get paid for that because they have to outlay the money, and then they want to make sure they get paid. We have nurse educators because you have to ensure that they are educated on how to do the procedure. So because of that, it's a much more complex sell than what you would typically see. The good news is what I like to talk about is our funnel, and we often talk about the top of the funnel and then the bottom of the funnel. The top of the funnel, we're very happy with where we are with that, so that's what we call patient enrollment forms. And that's a patient is actually identified. So the doctor has prescribed the drug for the patient. They have a patient enrollment form.
Unfortunately, the biggest challenge so far is going from a patient enrollment form to the patient actually being dosed. And that's taking up to 60 days for that to happen. And that's why when we shared our Q3 revenue, we also, which we have not typically done and won't typically do in the future, we also shared October. And the reason we did that is because if you think about it, it took those 60 days, right, to get those patients that were dosed in October, really came from August and sort of the beginning of September. And so you are seeing a longer cycle from having a patient identified until you get the patient dosed. That's our job to work on that and compress that time frame.
For JELMYTO, which is our product that's been on the market for a long time, it's down to like 15-20 days. So you go from 60 days down to the 20 days. So that's what we're working on, things like that. But the great news is very a lot of enthusiasm by physicians, a lot of energy around bringing and adopting UGN-102, but they want to know that they're going to get paid, and we've got to work through the logistical barriers associated with that.
Got it. In terms of the logistics of reimbursement, giving physicians confidence, could you just remind us what you're doing there and when do you actually book revenue?
Yeah. So we actually book revenue when it's shipped. So again, unlike more traditional pharmaceutical products, you don't have the stocking. So normally you don't have an inventory build. So we are just-in-time inventory. So when a patient is coming in, they're coming in for six weeks at a doctor's office, we're going to ship one dose each week. That's when we recognize the revenue, and that dose gets shipped. So if you have a new patient start, you're not getting the six doses upfront. You're getting them on a weekly basis. So that's when we recognize revenue. So that's the part that happens, is, again, it goes from the specialty pharmacy. Most community practices want it premixed. So we offer that. It's just easier for them. And then they receive it at their office. They've got seven days from the time they receive it mixed.
And so the reimbursement cycle for them right now in a miscellaneous J-code is it takes 45-60 days after they submit it, and there's more paperwork and stuff that has to be done. But when we have the permanent J-code, which is effective January 1st, it's all electronic. And so they have a little bit more confidence. Unfortunately, they've been burned in the past. The other thing that we've now offering is what we call a service warranty. You can't guarantee reimbursement. The Medicare, the government doesn't allow you to do that as much as I wish they did, but they don't because we feel very confident in reimbursement. So what we can do, though, is we can have a warranty on our service. So we provide a hub service that will do benefit verification.
So as long as they go through our service, they go through the appropriate appeals, and if they get denied, we are able to reimburse them. But the reality of it is the likelihood of that getting used is very slim because, again, we've had very positive reimbursement so far.
Got it. I guess in terms of waiting for the permanent J-code, when you go into these meetings, your field reps go into these meetings, do you have an estimate of what percent of physicians you think are kind of withholding using ZUSDURI until January and when that might turn on?
Yeah. I would say in my own personal experience as well, because I've been out in the field a lot. I would say that 70% of doctors are call me when you have a J-code. And I was actually, I have to say, surprised. I spent the 30 years that I've been in this industry in oncology mostly, right? I had prostate cancer in previous areas, but urologists are very different. So it was overwhelmingly, "Call me when you get the J-code." But you have, particularly in the institutions, they're not as sensitive to the J-code, but then you have to go through P&T committee. So the good news is, like I said, the enthusiasm is there when you're talking to doctors versus JELMYTO, where they talk about their one or two patients. Here they're saying, "Oh, yeah, I have those patients.
I know who they are." So as soon as you get the J-code. And then it will be a matter of when the patient recurs, right? So we really do expect, and one of the things that our team, our commercial team, is working on is ensuring that when January 1st does come, that they're ready. Get it in the system because we already have the code, right? Make sure that the account is set up. So how much work can we do ahead of time to really shorten the time from a patient identification to patient being dosed?
Understood. And you mentioned it, maybe just quickly, you did disclose October sales on the last earnings, and you said you maybe wouldn't do that. Are you going to do January sales on the fourth quarter?
It's not our plan at this point, unless there was a real reason to do it. We felt like we really needed to do that. And that was because, I mean, you tell me, we had come out and we only said we had $1.8 million in three months. People wouldn't have been so excited, right? But when you see, and even though we tell the story that it's not a demand reason, it's really a logistical reason, I think that showing October proves that, right? That the demand is there, but it's really a matter of translating that demand into dosing.
Got it. And for the rest of 4Q, obviously we had the Thanksgiving holiday. We have Christmas. We have kind of what the permanent J-code will be one or two weeks away. How should we think about where this trajectory of 4Q will go from what you disclosed for October sales?
Yeah. I think you guys have gotten it correct in the sense of how you're looking at it. Not only do we have the holiday, but we also have doctors that have already said to us that have patient enrollment forms, "I'm going to wait and dose them." Now, we do have dosing happening every day, right, with patients. So we are thinking about it being relatively similar in Q4 for the months. We do think there'll be a little bit of a step up, but for the most part, very similar in Q4. And then January, I also think, well, we won't probably share monthly revenue, but then you really start to see it February, March, and then into Q2. So what we've talked about a lot is the first two months of the J-code, of having the J-code.
We expect and we look in ANKTIVA ImmunityBio, we had a 220% increase in revenue the six months post-J-code versus this, and we think that's a good analog to use. So January 1st, what's going to happen is all those patients that are in the process of they've already been dosed in December, and they're going to have to be re-verified because, unfortunately, all patients have to be re-verified. And because they change insurance companies, and then we've got a lot of patients that are sitting out there, those have to get re-verified, and then you have your new patients coming in. So January will be a very busy month for all of us.
Okay. Got it. And then, yeah, maybe just to clarify a bit on the trajectory once the permanent J-code comes online, you expect that to kind of be over the first six months to start to compare it?
Yes.
Okay. Got it, and not just like it turns on January 1 and then.
No, you're not going to have this huge bullet sitting in January 1st. One, you've got to get patients in. You have to go through all this re-verification. And they will, so those physicians who have said to us, "Okay, come back and see me once you have a J-code," then they also have to identify their patients, right? So some already have, and they've already had patient enrollment forms in. But a lot of them, in their mind, they know who these patients are, and they know that that patient's going to recur at some point. They're just not sure exactly when.
Okay. Got it. And then maybe just on your commentary around how to think about fourth quarter, to confirm, in theory, you have a good line of sight given the patient enrollment from 45-60 days.
Yeah. Right.
Okay. So you feel confident with where the Street is, how the Street is thinking about it?
Street and patients. We're confident right now. They're comfortable.
Perfect. Shifting gears a bit to some of the competitors moving into the intermediate risk space. Obviously, they're still a few years out. They're not quite directly comparable, either doing adjuvant or a mutational subset. How do you see the landscape evolving?
Yeah. I'm always sort of, I think, different than most people. I love when others come in this space. There are a couple of reasons. One, I've been in oncology, like I said, for 30 years now. Patients need new medicines. They need alternatives. That's the first thing we have to think about. These are not cures. Ours isn't a cure. Theirs aren't cures. So these patients will cycle through multiple therapies. But we're also trying to change practice. So having three companies out there trying to change practice is very different than having one company out there. We believe that we have a benefit to both of those competitors coming in and, frankly, anybody else that's coming in. One, we are primary, so you don't have to do surgery. So their data, when you look at our data, we're at 80% complete response rate.
80% of those patients still in response at 12 months. Compare it to the competitors that are out there, and theirs is with a surgery. Ours is without. So ours is our drug alone delivers that type versus theirs. Theirs is also they talk about the CR at any time, which means they get redosed. And then the other is our dosing schedule. And Mark and I talked, Mark is our Chief Medical Officer, talk a lot about this. We are six weeks and you're done. Six weeks, you come into the office, you get a catheter, you get the medicine delivered, you get dressed, you go home six weeks in a row and you're done. And that's not the case, particularly for TAR-200. When you think about it, come back, you have to get it taken out, you have to get the pretzel in and put it in.
And so we think when you look at it from a profile perspective, we have a big advantage. But I also think that it's a good thing for patients and a good thing for the market to see multiple companies out there talking about using these types of therapies versus the path where it was mostly just driven by surgery.
Understood. And then maybe just as another point of differentiation, just to remind us, who can actually administer UGN-102?
Yeah. Nurses can administer. An extender can administer. So anyone in the office that is trained to be able to administer these medicines will be able to administer UGN-102. So from a workflow and a practice economics perspective, it's definitely beneficial to the office and to the practice and to the doctor for them to use our treatment.
How quick is it? From a patient perspective, they come in. What's kind of their timeline?
Yeah. It depends on how quickly you get them in the back room. But let's just say from the time you come in, you check in, you go to the back room. The procedure itself is like five minutes. They lay there for a few minutes. So they really can be in and out of there in half an hour. But we want them to lay there 15 minutes, make sure that the gel has set. Then they get up and they get dressed and they go home. And that's why in our study, in our ENVISION study, all of those patients had had a prior TURBT. And 90% of patients preferred our treatment to a TURBT because you hear a lot sometimes people say, "Well, TURBT is one and done." No, it's not.
A patient isn't getting dressed and going back to work or going to the grocery store. So they said it was less impact on their daily life to be able to and less time-consuming, actually, to do our therapy versus having surgery.
From an IP perspective, remind us how UGN-103 fits into the puzzle and where you stand with the FDA there?
Yeah, sure. So UGN-103, we just announced the data and announced agreement with the FDA on the path to an approval for UGN-103. So UGN-103 and UGN-104 are a next-generation formulation. We actually part of the biggest reason we went to look for an alternative manufacturer is to ensure supply. And we were fortunate enough to find a supplier in Germany called Medac that has a proprietary mitomycin. So they already had patent protection to 2035. When we combined it with our gel, both the FDA because they made us do a study and the patent office, obviously, we got new patents issued through 2041.
So what it allows us to do is to get UGN-103 and UGN-104 approved, wait till we get the J-code, and then launch that medicine and actually pull the current UGN-102 off the market and therefore have patent protection until 2041. Now, let me be clear. If somebody wants to come in after 2031 and develop a drug, they can, but there won't be any interchangeability or substitutability. They will have to market and commercialize the drug just like we do ours.
I guess maybe on that a bit, but just taking a step back, how challenging would it actually be for a generic manufacturer to make our new gel? I've heard that question a lot from some in the room.
Yeah, so actually, from our standpoint, what we've seen and what we've learned and what we've experienced, very difficult, and I'll give you an example. I think most people know that Teva filed a Paragraph IV against JELMYTO, and initially it was both non-infringement and invalidity. Well, they now have just focused on invalidity because they haven't figured out a way we're assuming because they haven't figured out a way to do it. And so even our own, we have secondary manufacturers for our gel to ensure supply. And from that perspective, we have to be very involved with them to ensure that it's manufactured properly. So the specifications are very narrow, and you really do need to know what you're doing.
And then, I guess, from the regulatory aspect, is it the same pathway for generics of UGN-102 given you kind of used the 505(b)(2) pathway? Is it the same pathway for a generic on that type of drug, or?
Yeah. No, the FDA actually publishes what they call product-specific guidance, which tells a generic company, "This is what you have to do to demonstrate that you're equivalent." In our case for JELMYTO, we don't have a product-specific guidance because we just got approval for UGN-102, but we assume it will be the same, is that they actually have to demonstrate it's identical. And if they can't demonstrate that it's identical, then to your point, they have to do a clinical study. So we haven't seen anybody and don't anticipate anybody being able to demonstrate that it's identical, which would mean that they would have to generate some clinical data.
Got it. And then maybe just remind us the status of the Teva lawsuit and maybe just anything we can glean from that process with what you anticipate in 2031 with UGN-102.
Yeah. So no news really, except what I was just saying, that they limited the suit to invalidity. So they're trying to invalidate, which means there's a higher bar for that than non-infringement. And there's no new news. We have an October 26 court date set with them. We feel very confident where we are. And so we think we'll prevail there. And nothing new from them or us on that end.
Got it. And any risk to kind of the strategy of launching 103, getting the J-code, and then pulling 102 from FDA or regulatory?
No. It happens a lot, and it's done a lot. And we actually can demonstrate that, from one, you need supply, right? One of the worst things that can happen to patients with cancer is you can't supply the drug. And so we needed this new supplier, right, as we start to grow. And so that's something that everybody will be supportive of. No one can sort of force you to keep UGN-102 on the market, right? So there's no real risk to that, only if we don't do a good job of doing a switch. And then you've got a sort of time period where physicians are without a drug. I think that's the biggest risk that you would see, but not in the sense of being able to sort of bring one. There are differences.
Maybe you don't see it in the clinical data, but you do see it in preparation. So the drug is more soluble. You have less issues with the manufacturing. And so there are definitely benefits, and there's more supply and better availability of supply. So from that perspective, there's enough reason to do it that there's no real concern.
Okay. Great. I know we're running a little short on time. Let's just do one quick question on JELMYTO, your original first approved program. I guess, how do you think about that as kind of the base business longer term? And are you actually seeing any kind of increased awareness uptake now that you're in offices talking about UGN-102?
Yeah. Look, we really do believe that there will be what I call a reverse halo onto JELMYTO and also the fact that we're going from 5,500 docs to 8,500 docs. So we were covering most of the doctors for JELMYTO, but there's definitely opportunity to grow that business. But we expect it to remain sort of low single-digit growth. But we definitely believe that it will continue to grow and that we'll see. We've even had some physician offices say, "Well, I only see one or two JELMYTO patients. I'm not going to change my practice. But once I adopt UGN-102, then it's easier for me to adopt." So we haven't seen it yet in the numbers, but we have anecdotally heard that quite a bit.
Okay. Got it. In our last 30 seconds, maybe just final thoughts heading into 2026, obviously an exciting year.
Yeah. I feel like every year I say, "This is the pivotal year for our company. This is the pivotal year for our company." And obviously, 2025, it's kind of hard to beat in the sense of the approval of UGN-102, obviously the launch. But 2026 is when we'll actually start to see what type of opportunity it is. And I think that's the most important thing. The first two quarters, Q1 and Q2 will show the trend and demonstrate. We've said it's a billion-dollar drug, but let's see, right?
Great. All right. With that, we will wrap it up. Thank you all for joining. Thank you, Liz, for coming.
Thank you.