Post Content
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 have made around its trajectory. Zesturi addresses a large and underserved market, and based on our assumptions regarding market penetration, pricing, and physician adoption, we believe Zesturi has the potential to achieve greater than $1,000,000,000 in peak revenue. Importantly, Zasturi provides the first and only medication approved by the FDA 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 product revenue of $94,000,000 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 Cisteri, demonstrated compelling complete response results in the Phase 3 Utopia trial, consistent with the ENVISION study. We remain on track to submit an NDA in recurrent low-grade, intermediate-risk, non–muscle invasive bladder cancer in 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 bladder cancer as part of our broader life cycle strategy. UGN-104, our next-generation formulation of Jelmyto, continues to progress through Phase 3 with enrollment expected to complete by 2026. Finally, following the refinancing of our term loan with Pharmacon, 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 Zistory 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?
Mark P. Schoenberg: 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. Zesturia is delivered as a convenient six-dose regimen in the outpatient setting and does not require surgery or maintenance therapy.
Taken together, these clinical and practical advantages support Cystoree’s growing role for adults with recurrent, low-grade, intermediate-risk NMIBC and position it competitively within an evolving treatment landscape. I would note that what I am about to share reflects anecdotal feedback from early adopters and patient conversations rather than formal study outcomes. From those discussions, we are hearing that Zasuri is integrating smoothly into routine practice. Physicians have commented on the simplicity of administration and the ability to incorporate the six-dose regimen into existing patient workflows without requiring procedural changes or additional infrastructure. Several urologists have shared that following their first experience with Cisteri, 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 Story’s 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 Zasduri.
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 3 trial demonstrated a 77.8% complete response rate at three months. We have aligned with the FDA that the data from this trial can support an NDA submission in this indication. We are planning to submit in 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 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 3, with enrollment expected to complete by 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 1 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.
David Lin: Thank you, Mark. I want to reinforce what Liz shared earlier. We are very encouraged by how the Zestiri launch is developing and it continues in line with our expectations. The commercial execution we are 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 the commercial organization, established reimbursement pathways, and worked closely with urology practices to support operational readiness ahead of broader adoption.
Zestiri generated $1,800,000 in net product revenue in Q3 and $14,000,000 in Q4, bringing full-year 2025 revenue to $15,800,000. As discussed, these early quarters reflected the foundational launch during the miscellaneous J code period. As of 12/31/2025, 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 Zasturi 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 is 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 timeline from patient enrollment form, or PEF, to dosing.
We have 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 two- to three-week time frame we see today with Jelmyto. As we continue through 2026, our commercial organization is scaled to support the 8,500 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 $94,000,000 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 Zasturi 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.
Christopher Degnan: 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 Zastory in 2025 as well as increased sales of Jelmyto. Research and development expenses for the year ended 12/31/2025 were $67,100,000, compared with $57,100,000 in 2024. The year-over-year increase was primarily driven by higher manufacturing cost for Zasturi, which are recognized as R&D expenses prior to receiving FDA approval, costs associated with the Phase 3 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 Sistori.
Selling, general, and administrative expenses were $105,100,000 for the full year ended 12/31/2025, compared to $121,200,000 for the full year 2024. The year-over-year increase in SG&A expenses was primarily driven by Story commercial activities, including the sales force expansion following Zastore 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 $18,500,000 for the year ended 12/31/2025, compared with $23,400,000 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 $125,000,000 term loan facility with Pharmacont Advisors was $15,300,000 in 2025, compared with $12,500,000 in 2024.
The increase was primarily attributed to the interest expense on the $25,000,000 third tranche of the loan that was funded in September 2024. We reported a net loss of $153,500,000, or $3.19 per basic and diluted share, for the year ended 12/31/2025, compared with a net loss of $126,900,000, or $2.96 per basic and diluted share, in 2024. As of 12/31/2025, our cash, cash equivalents, and marketable securities totaled $120,500,000. As Liz mentioned, today, we announced that we have entered into a second amended and restated loan agreement with Pharmacont Advisor providing for a senior secured term loan facility of $250,000,000, consisting of two tranches.
The initial tranche of $200,000,000 is funded at closing and was used to refinance our existing $125,000,000 term loan facility and provide additional nondilutive capital. The agreement also includes a second tranche of $50,000,000, which may be drawn at our discretion through 06/30/2027, subject to customary conditions. All outstanding loans with Pharmacon will accrue interest at a fixed rate of 8.25% and will be repaid with four equal quarterly principal payments beginning in 2030. The facility includes customary prepayment provisions, including applicable premiums and make-whole amounts.
We believe this refinancing enhances our financial flexibility and provides additional nondilutive capital to support continued investment in the Ziptori 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 ZESTORIA 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 $97,000,000 to $101,000,000. 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 $240,000,000 to $250,000,000, including noncash share-based compensation expense of $20,000,000 to $24,000,000. 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 salesforce expansion following the Story 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: 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.
Kelsey Goodwin: 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 Zostery, I guess, when might you be able to provide that, or would that be maybe a 2027 thing? Thank you.
Elizabeth A. Barrett: Yeah, I will ask Chris to answer this second question, and then and then David can answer the first question.
Christopher Degnan: 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 Zastore.
Elizabeth A. Barrett: David, I will pass.
David Lin: 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.
Elizabeth A. Barrett: 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 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.
Kelsey Goodwin: That is great. Thank you so much.
Operator: Our next question comes from Raghuram Selvaraju with H.C. Wainwright.
Raghuram Selvaraju: 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 Zesturi, 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?
Elizabeth A. Barrett: Yeah. David?
David Lin: 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.
Raghuram Selvaraju: 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 Zasturi, and how you are thinking about 103 relative to Zasturi from a commercial positioning standpoint. Thank you.
Elizabeth A. Barrett: 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 Zosturi, that they will switch to 103, then we will make that switch. So we have a— we will be very purposeful, purposeful about that, and then pull Zosturi as quickly as possible. So there will not be a lot of the— to your point, the dynamic of 103 and Zasturi 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.
Raghuram Selvaraju: Thank you.
Operator: Our next question comes from Michael Schmidt with Guggenheim.
Michael Schmidt: Hey, good morning. Thanks for taking my questions. On ZOZURI, could you just provide some more comment on current views, especially as we think about what types of patients are leveraging the Story at this point in time? What percentage of patients are, you know, considered unfit for TURBT surgery as opposed to those that are fit and are just seeking an alternative to surgery? And how do you expect that use pattern to shift over the rest of this year? So that is question number one. Then question number two, I think you did mention some potential life cycle management opportunities, especially for UGN-103, including evaluation as an adjuvant therapy.
And I am just curious, based on your market research, how well does the concept of adjuvant therapy in general resonate with patients as opposed to just using therapy as a replacement of surgery, you know, instead of as an add-on? How do you think about that? Thank you so much.
Elizabeth A. Barrett: Yeah. Sure. David can answer the first, and then Mark, please be prepared to answer the question around life cycle management.
David Lin: 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 Zasturi. We have talked about— and as we have 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 Zasturi, while not a precise science, I will say they are 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 should not go through another surgery.
So we are hearing patients across the board, and that is what gives us a lot of confidence that the value proposition is getting across to them. That is supported by the fact that we have a permanent J code now in 2026. It has opened up utilization, as we discussed, in more community practices, and it is really consistent with how we thought about the launch at this point in time.
Mark P. Schoenberg: 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.
Elizabeth A. Barrett: 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 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 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 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 is going to be really important as we go forward.
Operator: Our next question comes from Leland Gershell with Oppenheimer.
Leland Gershell: 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?
David Lin: 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 Zasturi 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 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 February, I can tell you that the mix of settings has started to pivot toward the community settings. So we are looking at about 50/50 right now for Zasturi.
And 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.
Leland Gershell: Okay. Great. And then development question. You had mentioned you are looking at Zystri in the adjuvant setting in high risk. Just wondering if you could share more detail on that and perhaps other expansion opportunities in high risk? Would you be— could you be looking at the Story in combination with others? And then the adjuvant setting, would that be in BCG naïve with TURBTs, or would there be an opportunity in BCG unresponsive? Just curious if you can share any more detail there. Thank you.
Mark P. Schoenberg: 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 Zosturi 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 is where we would start our investigation.
Liz may want to comment further on possibility of combining with other agents, however.
Elizabeth A. Barrett: 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.
Leland Gershell: Thank you. Very helpful.
Operator: Our next question comes from Paul Choi with Goldman Sachs.
Paul Choi: 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 Zasturi 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 are putting into the product currently and in the past? And then my second question is, I think in the past, you have 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, you know, now your— your is finally where you need it to be to get to profitability? Thank you for taking our questions.
Elizabeth A. Barrett: 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 Zasturi versus 103, we are investing in Zasturi like 103 does not exist. I mean, we are doing everything we can to ensure the maximum opportunity and we will continue to do that. And, you know, I will give you an example. We just had a new person join the commercial team that was— in a couple of weeks— that, hey, what is one thing that I have really appreciated, and that is we have the resources.
So we have resourced this launch like it needs to be, and there is nothing— no stone that we are leaving unturned, including, you know, engaging in patients. So while we are not doing broad-based DTC, 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 are not looking at it as this is just temporary and in 2028 we are going to have 1— we are not looking at it like that. We are looking at it because what we build for Zasturi will be the foundation for UGN-103.
So we are going after it correctly and, again, not leaving any stone— you know, in time for that commercial opportunity. So I feel really good about where we are from that standpoint, and we will continue to do that. And I will just ask Chris to comment on the expenses and where we are going from—
Christopher Degnan: 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.
Elizabeth A. Barrett: 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.
Operator: This time, please press 11 on your touch tone phone. Our next question comes from Aydin Huseynov with Ladenburg.
Aydin Huseynov: Hi, good morning. Thanks for taking our questions. I have a couple, one on Zasturi, one on UGN-501. For Zasturi, I appreciate confirming the long-term guidance for Zasturi. So I just wanted to better understand, maybe if you could provide some color in terms of when do you think this peak sales 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 would need a primer to activate the virus. Thank you so much.
Elizabeth A. Barrett: 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—
Christopher Degnan: 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.
Elizabeth A. Barrett: And, Mark, you want to just talk about 05/2001 with and without the gel?
Mark P. Schoenberg: 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.
Aydin Huseynov: Thank you. Thanks so much. Very helpful. Thank you.
Operator: That concludes today’s question-and-answer session. I would like to turn the call back to Elizabeth A. Barrett for closing remarks.
Elizabeth A. Barrett: 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.
Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect, and have a great day.
Before you buy stock in UroGen Pharma, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and UroGen Pharma wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Netflix made this list on December 17, 2004… if you invested $1,000 at the time of our recommendation, you’d have $519,015!* Or when Nvidia made this list on April 15, 2005… if you invested $1,000 at the time of our recommendation, you’d have $1,086,211!*
Now, it’s worth noting Stock Advisor’s total average return is 941% — a market-crushing outperformance compared to 194% for the S&P 500. Don’t miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors.
*Stock Advisor returns as of March 2, 2026.
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company’s SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
UroGen (URGN) Q4 2025 Earnings Call Transcript was originally published by The Motley Fool