UroGen (URGN) Q3 2025 Earnings Call Transcript

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DATE

Thursday, Nov. 6, 2025 at 10 a.m. ET

CALL PARTICIPANTS

Chief Executive Officer — Kelsey Goodwin

Chief Financial Officer — Christopher Degnan

Chief Commercial Officer — David Lin

Chief Medical Officer — Mark P. Schoenberg

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TAKEAWAYS

Cash -- Over $127 million reported, with management stating they continue to believe this is sufficient to support operations through profitability, assuming current plans are maintained.

Zasturi Launch Progress -- Steady growth in patient enrollment forms seen month-over-month, described as "very encouraged" according to David Lin demand by management.

Community Uptake -- Approximately 35%-40% of patients have been treated in community settings, with 60%-65% in institutional settings during the launch period.

J Code Reimbursement Impact -- Implementation of a permanent J code is expected to reduce reimbursement lag time from the current 45-60 days to under 30 days, but management cautions improvement will be gradual and not immediate on January 1.

Time-to-Treatment Convergence -- Management expects time from enrollment to patient dosing for Zasturi to reach equivalence with Jelmyto during 2026.

UGN-103 Regulatory Path -- Submission is targeted for 2026, with expectation of FDA approval in 2027; FDA is anticipated to require approximately 12-month longitudinal follow-up data, as inferred from similar product experience.

Cross-Prescriber Dynamics -- Most initial Zasturi prescribers have prior Jelmyto experience, with new physician adoption rising, and recent commercial efforts described as generating a "reverse halo" effect boosting Jelmyto demand as well.

Pipeline Development: UGN-501 -- IND-enabling activities are ongoing, with Phase I initiation anticipated in 2026; management highlights unique viral engineering advantages relevant to high-grade non-muscle invasive bladder cancer.

Alternative to TURBT -- Scheduling a TURBT surgery typically requires 4-6 weeks according to customer feedback; administration of Zasturi may reduce this timing and offers financial and workflow advantages for providers.

SUMMARY

The management of UroGen Pharma Ltd. (NASDAQ:URGN) emphasized that cash reserves at quarter-end stand above $127 million, and operations are expected to remain funded through the transition to profitability, subject to maintaining current operational and revenue plans. Reimbursement procedure improvements with the permanent J code are projected to significantly decrease the revenue lag time but will require a phased transition rather than an immediate shift. Pipeline advancement was clarified, with UGN-103 targeting a 2026 regulatory submission, guided by FDA expectations for around 12 months of patient follow-up data, and UGN-501 slated for first-in-human studies the same year.

Chief Commercial Officer David Lin stated, "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."

Chief Executive Officer Kelsey Goodwin noted a "reverse halo" where Zasturi launch activity has also increased uptake for Jelmyto among previously untapped prescribers.

Market access for Zasturi is being proactively supported by early operational readiness at care sites, intended to accelerate the expected adoption ramp once reimbursement mechanisms streamline in 2026.

Chief Medical Officer Mark P. Schoenberg described the next-generation oncolytic virus UGN-501 as possessing "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 anti-tumor immune response."

INDUSTRY GLOSSARY

J Code: A permanent Medicare billing code that enables electronic and expedited reimbursement submissions for physician-administered drugs.

TURBT (Transurethral Resection of Bladder Tumor): A surgical procedure for bladder tumor removal commonly performed by urologists.

IND (Investigational New Drug): FDA authorization permitting a company to begin human clinical trials of a new pharmaceutical agent.

LGIR: Low-Grade Intermediate-Risk, referring to a subset of non-muscle invasive bladder cancer patients.

MIBC: Muscle-Invasive Bladder Cancer, a clinicopathologic category for more advanced disease relative to NMIBC.

Full Conference Call Transcript

Operator: And, so that's gotta be our number one objective. And is actually very strong. So hopefully that helps provide some extra color.

Kelsey Goodwin: Great. Thank you very much.

Operator: One moment for our next question. Our next question comes from Kelsey Goodwin with Sandler. Your line is open.

Kelsey Goodwin: Hey, thanks for taking our questions. 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 in 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, you know, forty-five to sixty days later? Thank you. Oh, no. That would be closer to It's not implied demand, but of the demand revenue, that would actually it's not implied.

It's not like 45% to sixty days later. But, you know, but a great question. So I'll ask David to sort of know, answer your first question. Yeah. On your question around

David Lin: 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, you know, we're at that point where on some weeks, we're actually equal to or greater than Joe Mido. So it gives you a sense that we're crossing an inflection barrier there.

Kelsey Goodwin: Yeah. And the only other thing I'll say about the past from a without giving the actual number is it's very strong. Right? And if our sixty days was, you know, thirty days or was three weeks, then, you know, you would obviously see a very different, different revenue number. So suffice it to say that October revenue that you've seen versus Q3 seeing the same trend, you know, in patient enrollment forms. And you know, look, we don't give the number because it's a very clunky number and, you know, some fall out and then and, you know, it just it's just too much. But the number of a patient enrollment form a patient has been identified.

And the other good news is that

David Lin: we don't get pets for everybody.

Kelsey Goodwin: On top of the pets, there's revenue that comes in through So we have to take that PEF number and, you know, add something to it and then subtract, you know, from it for those There's always a conversion rate, and we see that on DelJalmyto today. You're not you're never gonna get a percent of those. But, Kelsey, to say it's healthy is a you know, is

Raghuram Selvaraju: is

Kelsey Goodwin: know, 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. Perfect. Thanks so much, and congrats again.

Raghuram Selvaraju: Thank you. One moment for our next question.

Operator: Our next question comes from Raghuram Selvaraju with AC Wainwright. Your line is open.

Raghuram Selvaraju: Thanks very much for taking my questions. Firstly, I just wanted to drill down a little bit further on what you

David Lin: expect

Raghuram Selvaraju: the granular quantitative impact of the J code to be you know, as soon as it comes online. And in particular, if you could comment on what you anticipate the reduction in lag time the receipt of the patient enrollment form relative to actual patient dosing. Could be once the J code takes effect. In other words, you know, with the active J code, you know, will the lag time be reduced from forty-five to sixty days to under thirty days or you know, do you do you have a more granular sense of the impact of the J code is gonna 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 three-month data. We just wanna 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 position to file the UGN 103 NDA.

Raghuram Selvaraju: Thank you.

Kelsey Goodwin: Yeah. Thanks, Ram. I'll ask David to answer the first question, and Mark will comment on, the FDA.

David Lin: Raman, in terms of your question around the impact of having a permanent J code,

Raghuram Selvaraju: But I can say to you is this, when you break down

David Lin: the overall components of having an enrollment form, to getting a new patient treated, about it as, I think about it in three parts. Right? There's the benefit investigation, which often entails a prior authorization. There's the initial site setup. It's 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 wanna 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

Operator: practice.

David Lin: 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 patients start. It will be gradual. It will not be an overnight sensation. It'll 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 two times the time to remittance as it would be when they have a permanent J code. Once we have turned the corner into 2026, the claim submissions are gonna 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 Zasturi. And so because we got out ahead of that, we realized that's gonna be important for 2026. We do feel good that we're laying a good foundation in terms of supporting broader adoption.

Kelsey Goodwin: Yeah. And the only thing that I'll add to that, Ram, is right now with Jomito, it takes us you know, it's about two to three weeks. Right, from, you know, depending on the patient. So we expect to get similarly there. But I do agree with David that it's not gonna happen January 1. Right? It doesn't it's not a it's not a flip of a switch because the J code is just one component of what, you know, why it takes this forty-five to sixty days. So you'll see that improve over time, but it will take time to get there. We will eventually get below, you know, below thirty days. Mark, maybe comment on the 103.

David Lin: Yeah. Ron, thanks for the question. So our expectation is, as we've

Operator: previously announced,

David Lin: 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 gonna wanna preponderance of follow-up data around twelve 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 103 as well.

Raghuram Selvaraju: Thank you.

Operator: One moment for our next question. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi: Hi, good morning everyone. Thanks for taking our questions. 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?

Christopher Degnan: In the timeframe 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, you comment on whether you feel like you'll need additional capital in 2026 just at the current run rate? Are you assuming either the revenue side or the cost-saving sides will be sufficient to transition you to profitability relative to your current cash position? Thank you very much.

Raghuram Selvaraju: Yes. Thanks, Paul.

Kelsey Goodwin: We can David can answer the first question and then turn it over to Chris to talk about the cash position. So David?

David Lin: Hi, Paul. In terms of your question around getting the time to new patients 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, to accelerate. But we do anticipate that over the course of 2026, those times to new patient starts will converge. It's hard to say exactly when that will be, but the key is we understand 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 hep to new patient start.

Kelsey Goodwin: So the short answer is yes. It will get there in 2026.

Christopher Degnan: Okay. Great. Thanks, Liz.

David Lin: And then, Paul, on cash. So as you saw, we have a little over $127 million in cash. We're well positioned to be able to deliver

David Lin: our core priorities, Zastore launch and with the expectations around revenue growth know, and based on our current operational plan, you we continue to believe that we do have cash to profitability. But, you know, we will continue and remain disciplined in terms of how we think about and be opportunistic future capital needs.

Raghuram Selvaraju: Okay. Thank you.

Operator: One moment for our next question. Our next question comes from Leland Gershell with Oppenheimer. Your line is open.

Leland Gershell: And for taking our question.

David Lin: 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 this history, early launch, could you comment on kind of the ratio of community uptake versus institution. You know, is it fair to say that community practitioners are really still waiting for the J code, and there's been 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? Thank you.

David Lin: Hey, Leland, thanks for the question. You know, launch to date, we're seeing approximately 35 to forty percent of our patients treated in the community and roughly 60, sixty-five in the setting. As we have outlined even prior to launch, a lot of the HCPs are gonna 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 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.

Leland Gershell: Into the into the out years.

David Lin: Thanks. And again, early days, but I'm not sure if you I don't think you'd comment 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 Zystery versus what maybe know, untapped previously untapped urologists and interest in discovery. Thank you.

David Lin: Yeah. I think with Jelmyto, it was a little bit heavier in the institution. And today with Jelmyto, it's probably half. Fifty. And so that gives you a sense. We do expect, though, because the patient population for LGIR and MIBC patients is largely seen in the community practices. We do expect, like I said, to continue to see more uptake in that community setting.

Kelsey Goodwin: But I think what he's asking is, jump of the jump right there, is story people are using Sisteri. How many of those are Jamido users? And a lot of them are, Leland. So a lot of our initial usage of Zasturi has been with Jommyto users. The good news is that we also are seeing some new physicians using, Jelmyto because we're going in to talk about the story. 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 delmyto that we, in physicians that hadn't seen it before.

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

Leland Gershell: Alright. Thank you, folks.

Operator: One moment from our next question.

Raghuram Selvaraju: Our next question comes

Operator: from Aden Hussinov with Ladenburg. Your line is open.

Aydin Huseynov: Hi. Thanks so much for taking our questions. I got a couple. So could you remind us how long

David Lin: it usually takes for a patient to schedule a repetitive TURP surgery and if those are the same urologists, do you think they have more financial incentives to run another TURP surgery or administer the story?

Kelsey Goodwin: Yeah. Great question, Aidan. David, you wanna

David Lin: Yeah. Thanks for the question. In terms of scheduling a TURPT, what we generally hear from customers is it takes them four to six weeks. To actually schedule one. So, with respect to the alternative of using Zasturi, if they choose to administer Zasturi, it can be roughly right now. They've gotta schedule the patient in, but it again, it's basically bay it's based on the patient's desire in their schedules. From a financial perspective, one of the things that we'll think about is a patient a physician's fee for doing a TURBT is gonna be in a couple of $100 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 Zasturi our market access team can speak to. Is that, there is ability to be positive from administering Zasuri. So and then importantly, because can be done by a nurse, it does allow the urologist to actually attend to other matters. So hopefully, gives you a little color in terms of the time to schedule and also the economics. Thank you. 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 with the CGM College story?

Mark P. Schoenberg: 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 ECG refractory carcinoma in situ and associated papillary disease. This falls into the asset class of developed for high-grade disease, high-grade non-muscle invasive cancer. Thing about the 501 asset to keep in mind, although obviously we are in IND enabling stage and anticipate Phase one in twenty-six.

Raghuram Selvaraju: Is

Mark P. Schoenberg: 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 anti-tumor immune response.

Raghuram Selvaraju: So

Mark P. Schoenberg: 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 gonna 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

Aydin Huseynov: Thank you. Very helpful. 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.

Kelsey Goodwin: Great. Thank you. I just wanna 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 Asturie. 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.

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

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