URGN - NASDAQ

Good day, and thank you for standing by. Welcome to UroGen Pharma Ltd.'s fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Vincent I. Perrone, Senior Director of Investor Relations. Please go ahead.

Thank you. Good morning, everyone. Welcome to UroGen Pharma Ltd.'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 Pharma Advisors, and the second providing an overview of our recent corporate highlights and financial results for the fourth quarter and year ended 12/31/2025. Both releases can be accessed on the Investors portion of our website at investors.urogen.com. Joining me today are Elizabeth A. Barrett, President and Chief Executive Officer; Mark P. Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Christopher 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

Thanks, Vincent. Good morning, and thank you for joining us today. Our top priority is the commercial launch of

Thank you, Liz. As a reminder, the ENVISION trial, which supported approval of assessed duty, demonstrated an approximately 80% complete response rate at three months. Importantly, among those patients who achieved a complete response, the probability of remaining 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 two years following treatment.

Thank you, Mark. I want to reinforce what Liz shared earlier. We are very encouraged by how the

Thank you, David. Revenues were $109,800,000 for the year ended 12/31/2025, compared with $90,400,000 in 2024. The 21% year-over-year increase was driven by the commercial launch of

Please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Our first question comes from Kelsey Goodwin with Piper Sandler.

Hey, good morning, and thanks for taking our questions, and congrats on the quarter. Maybe first, I know you are not providing anything on the 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 are seeing with Jelmyto, what you saw in their launch? And then in terms of the potential guidance for

Yeah, I will ask Chris to answer this second question, and then and then David can answer the first question.

So, Kelsey, thanks for the question. You know, it is early in the launch, as we said. And there are certain variables that can affect the near-term uptake. So, you know, once we get a better visibility to steady-state demand, I would say at least two quarters post the permanent J code, then we could consider providing formal guidance for

David, I will pass.

Yeah. Hi, Kelsey. It is David. With regard to patient enrollments, as expected, since the permanent J code became effective at the beginning of the year, we are seeing step up in a number of key indicators, so PEFs being one of them, and that is really in large part due to the fact that we have new writers as well as growing repeat writers. Thanks for the question.

Hey, 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, you know, and cautiously tell you because I— 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 have said we are— 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, you know, to hit that number. So just want to— that that is a little bit more color. I know everybody is wanting specific numbers, but I think that is the best we are going to be able to do. But I think that should give everybody confidence in kind of where we are right now.

That is great. Thank you so much.

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

Thanks so much for taking my questions and congratulations on all the progress this quarter. 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 are seeing it steadily ticking up month over month, quarter over quarter? Secondly, with respect to those prescribers who have deployed

Yeah. David?

Hi there. Thanks for the question. In terms of repeat prescribers, we are seeing steady growth in— I will 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 is really what enables them to become repeat prescribers. With many of the new prescribers, what they are really waiting to see is they typically want to make sure that they have a 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 have heard from the prescriber base is that it is 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 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

Yeah. So the plan would be to not introduce it into the market until after we get a permanent J code. So what— what, you know, we have discussed is that we would file this year, you will get approval in 2027, and so then it would likely be 2028 when we would be in a position to launch it. And what we would do is the goal would be to transition to UGM-103 as quickly as possible, but I— you know, because there is going to be a lot of confusion, so we have to make sure that we handle that very quickly to avoid any of that. And then at the point in time where we feel confident we are not going to lose, you know, physicians and patients with

Thank you.

Our next question comes from Michael Schmidt with Guggenheim.

Hey, good morning. Thanks for taking my questions. On

Yeah. Sure. David can answer the first, and then Mark, please be prepared to answer the question around life cycle management.

Hey, Michael. This is David. In terms of your question, I think the first thing I will say is that physician customers have been very enthusiastic about the compelling data surrounding

Michael, thanks. And with respect to the life cycle management question, the expansion of the use of 103 in the adjuvant setting would have to 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— a transurethral resection to make a diagnosis, likely for new-onset intermediate-risk disease as well as new-onset high-grade disease, primary therapy would not be the standard of care but adjuvant therapy would. So we think there would 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.

Great. Thanks so much. Yeah. And— and just to answer the— you know, add a little bit more color on the patient dynamics, that, you know, from the adjuvant— of how that is being used today, we do not really know. Obviously, we do not track that. We do know some physicians today are using it in the adjuvant setting for the recurrence, but we do not promote that, right? Because our data is clearly without surgery. And I think that that is very important because the idea of not having to go through surgery— while physicians may not love that idea, some of them— patients really do. And the reality of it is that the 80% complete response and the durability that we have shown— keep in mind that that is without surgery. And so we do want to— while we do recognize that some physicians may be less comfortable and they will do it in the adjuvant setting even today, we do want ultimately for them to use it without surgery because we think that is 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, you know, as they are coming in, they are in the adjuvant setting, and right now, we are the only ones that are showing it as a primary. And I think that that is going to be really important as we go forward.

Our next question comes from Leland Gershell with Oppenheimer.

Good morning, and I am glad to hear the update. Thanks for taking our questions. We have two— one just on the commercial side with Astoria. As you develop that market, wanted to ask what you are 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?

Yeah. Hey, Leland. Your question around channel mix, it is a little bit different. I think as you saw with Jelmyto, it was very heavily concentrated with hospitals, particularly in the beginning. What we saw in 2025 with

Okay. Great. And then development question. You had mentioned you are looking at

Yeah. Thank you, Leland. So I think there are a lot of opportunities in high-risk disease. One area we are particularly interested in is in the BCG-unresponsive papillary 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 at high-risk disease, and, obviously, we will be happy to share details when that protocol is finalized. But we do think that

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

Thank you. Very helpful.

Our next question comes from Paul Choi with Goldman Sachs.

Hi, good morning, and thank you for taking our questions. My first question is, Liz, can you maybe offer a framework about how you are thinking about the level of investment in promoting the

Sure. I will answer the first, and then I will ask Chris to talk about the longer-term sustainability of the financials and our investment. And, you know, I think that where we are with investing in

Yeah. And thanks, Paul, for the question. So, you know, as we said before, the path to profitability is really tied to the Story launch and the uptake, and we are on track there. You know, the purpose of the refinance really accomplished two things for us. One, meaningfully reduced our cost of capital— so the prior loan had a, you know, seven and a half percent plus three-month SOFR variable rate, 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, extended the repayment period— you know, it was going to start second quarter next year, now starts 2030— and did bring in additional nondilutive capital to further build out the balance sheet. But to be clear, we will remain disciplined in our approach to capital allocation, balancing path to profitability and then also making sure that we are investing in the long-term growth strategy.

And I will just add that the addition of the $50,000,000 or $75,000,000 does not change what we have said before around path to profitability, right? It gives us some cushion and gives us more flexibility, but it does not— we are not— we did not do that because we needed, you know, that money to get to profitability. But it definitely gives us flexibility. So just to be really clear, we have not changed our commentary around path to profitability.

This time, please press 11 on your touch tone phone. Our next question comes from Aydin Huseynov with Ladenburg.

Hi, good morning. Thanks for taking our questions. I have a couple, one on

Yeah. Thanks, Chris. I will ask Chris to answer the first question, and then we can turn over to Mark to answer around 05:01. Okay, and thanks. So, let me pass the—

Peak or time to peak, you know, I would assume roughly four years to peak. So now that we have the J code, a four-year ramp to peak is reasonable.

And, Mark, you want to just talk about 05/2001 with and without the gel?

Sure. Thank you. So, as you— as many who are listening know, our current plan to launch a Phase 1 study in 05/2001, 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, DDM. 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 obviate the need for additional interventions prior to introduction of the virus. But that is currently under investigation, and we will obviously share details when we have more to share.

Thank you. Thanks so much. Very helpful. Thank you.

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

So 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. You know, we gave information that hopefully gives you the confidence that, you know, where we are, we are starting out the year very strong. So we obviously will look forward to sharing all of the information from Q1 and the Q1 earnings. But suffice it to say that we are excited about where we are. We think we are in a great position to hit our goals and hit all of the milestones that we expected on the Story, which Jelmyto is doing well as well. And then want to focus the back half of the year around expansion into other areas. So I think from a company perspective, we feel like we are in a great position. We are in a great financial position. Things are going really well with the launch. We are executing against our pipeline, and 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 everybody for hanging in there for all these years. We are finally, I think, at a place where we have all been working toward, and appreciate the support. So we will be keeping everybody up to date. Look forward to seeing some of you at the conference tomorrow. So thanks a lot. You can disconnect now, operator.