URGN - NASDAQ

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

Thank you, Vincent. I'd like to address what I know is on everyone's mind, and that is the progress of the

Thank you, Liz. In the ENVISION study,

Thank you, Mark. I will spend most of my time today discussing the ongoing launch of

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

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

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

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

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

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

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

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,

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

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

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