Earnings call transcript: UroGen Pharma Q3 2025 sees revenue miss, stock dips

UroGen Pharma Ltd (URGN) reported its Q3 2025 earnings, revealing a slight miss in earnings per share (EPS) and a significant revenue shortfall. The company posted an EPS of -$0.69 against a forecast of -$0.68, while revenue came in at $27.48 million, missing the expected $33.19 million. This resulted in a pre-market stock decline of 5.49%, with shares trading at $18.25.

Key Takeaways

• UroGen Pharma’s revenue fell short by 17.2%, impacting market sentiment.
• Gemyto sales showed robust growth, increasing 13% year-over-year.
• Zesturi, launched in July, is gaining traction with broad insurance coverage.
• The stock dropped 5.49% in pre-market trading, reflecting investor concerns.

Company Performance

UroGen Pharma’s Q3 2025 performance highlighted mixed results. While the company achieved notable growth in Gemyto sales, the overall revenue missed expectations by a significant margin. This discrepancy underscores the challenges the company faces in scaling its newer products like Zesturi, despite its promising market potential.

Financial Highlights

• Revenue: $27.48 million, down from the forecasted $33.19 million.
• Earnings per share: -$0.69, slightly below the forecast of -$0.68.
• Gemyto sales: $25.7 million, a 13% increase year-over-year.
• Net loss: $33.3 million.

Earnings vs. Forecast

UroGen Pharma’s actual EPS of -$0.69 narrowly missed the forecast of -$0.68 by $0.01. However, the more notable miss was in revenue, which fell short by 17.2%, a significant deviation that might weigh more heavily on investor sentiment compared to the minor EPS miss.

Market Reaction

Following the earnings announcement, UroGen Pharma’s stock dropped by 5.49% in pre-market trading, settling at $18.25. This decline reflects investor apprehension about the company’s ability to meet revenue expectations and manage ongoing losses. Despite this, the stock remains closer to its 52-week high of $23, indicating some resilience.

Outlook & Guidance

Looking ahead, UroGen Pharma remains optimistic about the adoption of Zesturi, expecting acceleration in 2026. The company plans to submit the UGN-103 NDA in the second half of 2026, with anticipated approval in 2027. It also maintains its Gemyto revenue guidance for 2025 between $94 million and $98 million.

Executive Commentary

CEO Liz Barrett expressed confidence in Zesturi’s long-term potential, stating, "We remain confident in the long-term potential for Zesturi to deliver an important advance for patients, becoming a standard of care." Chief Medical Officer Dr. Mark Schoenberg highlighted the drug’s profile, saying, "Zesturi demonstrated a compelling and clinically meaningful profile."

Risks and Challenges

• The significant revenue miss raises concerns about market penetration and sales execution.
• Continued net losses could strain financial resources and investor patience.
• The competitive landscape in the pharmaceutical industry remains a challenge.

Q&A

During the earnings call, analysts inquired about the impact of the permanent J code on Zesturi’s adoption and reimbursement. Executives confirmed that this development is expected to facilitate smoother reimbursement processes and enhance market uptake.

Full transcript - Urogen Pharma Ltd (URGN) Q3 2025:

Conference Operator, Call Moderator: Good morning and thank you for standing by. Welcome to the UroGen Pharma third quarter 2025 earnings call. At this time, all participants are on a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised today’s conference is being recorded. I would now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

Vincent Perrone, Investor Relations, UroGen Pharma: 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 Gemyto and Zesturi, our ongoing and planned clinical trials and non-clinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings, and decisions.

Zesturi being the primary growth driver for UroGen, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals, and 2025 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I’ll now turn the call over to Liz Barrett, Chief Executive Officer.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Thank you, Vincent. I’d like to address what I know is on everyone’s mind, and that is the progress of the Zesturi launch. While we had expected a faster uptake, there are many factors that support our belief that the near and long-term opportunity for Zesturi is on track. The preliminary demand revenue for October is more than double the previous three months, demonstrating increased usage and adoption. Importantly, our patient enrollment forms, or PEFs, in Q3 were actually on track with our initial expectations, but as we’ve communicated, it is taking longer to convert a PEF to an actual patient being dosed. We believe the delay is driven solely by logistical and operational challenges, including reimbursement concerns with a miscellaneous J code. PEFs continue to grow and are currently on pace with Gemyto after only four months on the market. Since launch, physician enthusiasm has been encouraging.

There’s clear recognition of the need for new therapeutic options for these patients, and our market access team has executed well to secure broad coverage across major payers. I am pleased to say that we do have paid claims. Feedback on the clinical profile of Zesturi continues to be very positive, with high intent to prescribe by physicians. As we anticipated, usage has been greater in the hospitals than in community practices, but in both settings often requires formal approvals before physician ability to use. Remember, we are changing the way physicians practice, and Zesturi is the first and only FDA-approved treatment for patients with low-grade intermediate-risk non-muscle-invasive bladder cancer. Zesturi addresses an estimated $5 billion annual market, and we are well-positioned to take advantage of this significant opportunity.

We remain confident in the long-term potential for Zesturi to deliver an important advance for patients, becoming a standard of care and delivering over $1 billion in peak revenue. We expect to see an acceleration in adoption once the permanent product-specific J code goes into effect on January 1, 2026. David will provide more details on the launch in a few minutes. Turning to Gemyto, we delivered another solid quarter with net product revenue of $25.7 million, representing a 13% increase in underlying demand revenue over the same period in 2024. Now, five years post-launch, Gemyto continues to demonstrate its clinical value and prescriber confidence remain strong. With our expanded field team, we see additional opportunities to drive further growth. On the clinical front, we continue to advance our next-generation mitomycin programs.

We are pleased to see the three-month complete response rate from Utopia is consistent with what was observed in the Envision trial, and our plan for a new drug application, our NDA submission and approval, is on track. We plan to submit an NDA for UGN-103 in the second half of 2026, with potential approval anticipated in 2027. This is a very exciting time for UroGen. We’ve entered a new phase of growth from a position of strength with a solid balance sheet, a capable and focused team, and a portfolio that positions us for durable long-term success. We remain guided by our mission to bring meaningful new treatments to patients and deliver sustained value for our shareholders. I will now turn the call over to Dr. Mark Schoenberg. Mark.

Conference Operator, Call Moderator: Thank you, Liz. In the Envision study, Zesturi demonstrated a compelling and clinically meaningful profile, with 80% of patients achieving a complete response at three months and 80% of those patients remaining disease-free at 12 months and, remarkably, 72% at 24 months. It’s important to note that Zesturi’s median duration of response has not been reached. This level of sustained response is unprecedented and highly meaningful for a population that has historically faced repeated surgeries and the burden of chronic disease management. The growing body of evidence supporting Zesturi was recently highlighted in a comprehensive review published in Reviews in Urology this October by Dr. Sandeep Prasad, one of our leading clinical investigators. This article reviewed results from our three late-phase clinical trials, Optima 2, Atlas, and Envision, and underscored the consistency and robustness of Zesturi’s clinical performance. Importantly, the review also explored the patient perspective on Zesturi.

Across multiple studies, including the phase 3B home installation study and sub-analyses of Optima 2 and Envision, patients consistently reported that Zesturi was a less invasive, less painful, and less time-consuming alternative to repeated TURBT surgeries. Turning to UGN-103, our next-generation formulation for low-grade, intermediate-risk non-muscle-invasive bladder cancer. UGN-103 is designed to offer practical advantages over Zesturi, including a shorter manufacturing process and simplified reconstitution. We’ve completed enrollment in the phase 3 Utopia study and are very pleased to report that the three-month complete response rate was 77.8%. This is consistent with results from the Envision clinical trial, reinforcing the strength and productivity of our RT gel platform. In October, the FDA agreed that our pivotal study, Utopia, can serve as the basis for a new drug application. We plan to submit the NDA in the second half of 2026, with approval anticipated in 2027.

In June this year, we initiated a phase 3 trial of UGN-104, our next-generation mitomycin-based formulation for low-grade UTUC. We expect UGN-104 will follow a similar regulatory pathway to UGN-103. Turning to UGN-301, our anti-CTLA4 monoclonal antibody being evaluated for high-grade disease. We have completed a phase 1 dose escalation study assessing UGN-301 both as monotherapy and in combination with UGN-201 or gemcitabine. The study confirmed proof of concept for our RT gel as a viable platform for local delivery of complex immunotherapies. UGN-301 achieved sustained bladder exposure of zalafrillimab with minimal systemic absorption, demonstrating our ability to mitigate anti-CTLA4-related toxicities. The treatment was well tolerated with a favorable safety profile, and efficacy signals were observed across cohorts. However, the overall clinical profile did not warrant advancement to a phase 2 study.

As such, we have made the strategic decision to discontinue the UGN-301 program and focus our resources on UGN-103 and UGN-501 in high-grade non-muscle-invasive bladder cancer. We plan to share safety and efficacy data in a future publication. The important takeaway from this program is that it successfully validates our ability to locally deliver complex immunotherapies using our RT gel technology, a capability we believe will be foundational as we advance future oncology programs. One such program is UGN-501, our next-generation oncolytic virus acquired earlier this year. UGN-501 is designed to selectively destroy cancer cells while retaining potency and triggering a robust immune response. We are pleased with the results we are seeing in our early work with IND-enabling studies ongoing and planned initiation of a phase 1 trial in recurrent non-muscle-invasive bladder cancer in 2026, with additional potential applications beyond the urinary tract.

I’ll now turn it over the call to David Lin for a commercial update.

Vincent Perrone, Investor Relations, UroGen Pharma: Thank you, Mark. I will spend most of my time today discussing the ongoing launch of Zesturi. Overall, we remain encouraged by the strong engagement we’re seeing across the urology community and the early commercial traction we’ve achieved, while also recognizing the headwinds that accompany the introduction of a new therapy. Our commercial infrastructure is now fully operational. By early August, we onboarded, trained, and deployed 30 new sales representatives, bringing our total to 82 in the field. Along with our regional operations managers, field reimbursement managers, and nurse educators, we now have approximately 130 customer-facing professionals supporting Zesturi as well as Gemyto. As Liz mentioned, Zesturi generated sales of $1.8 million during the third quarter, and we’re pleased to report a preliminary demand revenue estimate of $4.5 million for October, reflecting encouraging early momentum in Q4.

From launch on July 1, 2025, through the end of October, there were 54 unique Zesturi prescribers and 16 repeat Zesturi prescribers. I’d like to spend a few minutes highlighting what’s driving these numbers, as well as some of the challenges we’re addressing. First, we’re very encouraged by the level of interest we’re seeing in the urology community. Awareness among urologists is strong, and we’re seeing consistent engagement with our team to better understand Zesturi’s clinical profile and appropriate use in the eligible patients. Second, market access progress has been excellent. Zesturi is now broadly accessible to patients through commercial, Medicare, and Medicaid insurance programs, with open access to more than 95% of covered lives and approximately 296 million eligible patients. Third, operational execution remains a major focus as it is a complex network and what we believe is the biggest driver of delayed treatment.

We are partnering closely with practices and hospitals to ensure sites are prepared for ordering and administration, including distributor onboarding, pharmacy workflows, and clinical training. We now have nearly 600 sites activated and are ready to order and administer Zesturi. It’s important to note that activation reflects site readiness, not necessarily that a patient has been treated, so it remains an early indicator rather than a measure of utilization. Still, it is a positive sign that the infrastructure and operational readiness for adoption continue to expand. We closely monitor patient enrollment as a leading indicator of demand. When a physician identifies an eligible patient, they submit a patient enrollment form, or PEF, to our hub, a clear intent to treat with Zesturi. Weekly PEF volumes are showing strong growth and are now equal to, or in some weeks, greater than Gemyto PEFs, reflecting increasing demand and intent to treat.

We are, however, seeing an average of 45-60 day lag between PEF submission and patient dosing. We believe this is largely because many initial cases are occurring in hospital settings where formulary and P&T approvals can extend timelines. Our field team is actively working to shorten that conversion window by providing education on streamlining reimbursement workflows, accelerating patient benefit verification, and ensuring sites are fully ready to administer treatment. Over time, we expect conversions to narrow to two to three weeks, similar to Gemyto. As these processes improve and clinical teams gain experience, we expect conversion rates to increase meaningfully in the months ahead. As you are aware, we are also navigating the temporary use of the miscellaneous J code, which adds administrative complexity for practices, given that Zesturi is a buy-and-bill drug.

Many large community practices have indicated strong interest in treating with Zesturi once a permanent J code is available. We were pleased to announce last week that we have been assigned the permanent J code by CMS that will go into effect on January 1, 2026. In the interim, we’ve prioritized around 2,000 early adopter physicians who have shown a willingness to prescribe under a miscellaneous J code. Once the permanent J code becomes effective, we expect to see acceleration in adoption, primarily in the community setting, where physicians tend to be more cautious with new buy-and-bill therapies during miscellaneous J code periods. This change will simplify reimbursement and significantly reduce several of the barriers we are currently seeing.

Taken together, while the temporary J code has presented near-term headwinds, we continue to see strong interest, expanding the site readiness, and a clear path to broader adoption as we move into the first half of 2026. Turning to Gemyto, we’re seeing continued demand growth and steady utilization among high-performing accounts. Our expanded sales force, which now also promotes Gemyto alongside Zesturi, is helping us reach more urology practices with greater frequency and depth. In addition, gross to net adjustments have normalized further, providing a clearer view of consistent underlying revenue growth. Taken together, these trends reflect durable demand and strong commercial execution that continue to position Gemyto as a standard of care for patients with low-grade, upper tract urothelial cancer. I will now turn the call over to Chris to review our financial results.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Thank you, David. Total revenues in the third quarter were $27.5 million. This consisted of $25.7 million in Gemyto sales and $1.8 million in Zesturi sales. Gemyto sales in the same period of 2024 were $25.2 million. However, this included $2.6 million in CreateX sales. On an underlying basis, excluding CreateX sales, this represents 13% year-over-year revenue growth for Gemyto, driven by both price favorability and volume growth. R&D expenses for the third quarter of 2025 were $14 million, including non-cash share-based compensation expense of $0.7 million. This compares to $11.4 million, including non-cash share-based compensation expense of $0.6 million for the same period in 2024. The increase in R&D expenses of $2.6 million was primarily driven by costs associated with the phase 3 Utopia trial for UGN-103, partially offset by lower clinical trial costs, manufacturing costs, and regulatory expenses in connection with Zesturi.

Selling, general, and administrative expenses for the third quarter of 2025 were $37.6 million, including non-cash share-based compensation expense of $2.3 million. This compares to $28.9 million, including non-cash share-based compensation expense of $2.9 million for the same period in 2024. The year-over-year increase of $8.7 million was primarily driven by Zesturi commercial preparation activities, as well as an increase in overall commercial operation costs, including the expansion of the sales force. We reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the third quarter of 2025, compared to $5.9 million in the same period in 2024. Interest expense related to the term loan facility with funds managed by Pharmacon Advisors was $3.4 million in the third quarter of 2025, compared to $2.7 million in the same period in 2024.

The increase was primarily driven by interest expense related to the third tranche of the loan that was funded in September 2024. Net loss was $33.3 million, or $0.69 per basic and diluted share in the third quarter of 2025, compared to a net loss of $23.7 million, or $0.51 per basic and diluted share in the same period in 2024. As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $127.4 million. Turning now to guidance. We are providing revenue guidance for Gemyto only at this point. We continue to expect 2025 Gemyto net product revenues to be in the range of $94-$98 million. This implies year-over-year growth of approximately 8%-12% over the $87.4 million in demand-driven Gemyto sales in 2024. This excludes the $3 million in CreateX sales reported in 2024.

Guidance on full-year 2025 operating expenses is also unchanged and is expected to be in the range of $215-$225 million, including non-cash share-based compensation expense of $11-$14 million. I’ll now turn it back to Liz for summary remarks.

Aidan Huzinov, Analyst, Ladenburg: 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.

Speaker 1: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to remove yourself from the queue, please press star 11 again. We’ll pause for a moment while we compile our Q&A roster. Our first question comes from Tara Bancroft with TD Cowen. Your line is open.

Tara Bancroft, Analyst, TD Cowen: Hi. Good morning, everyone. 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 45-60 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. Did it end up on the longer end of those ranges or even longer, especially for the remittance time? Where that ended up? 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? Thank you so much.

Aidan Huzinov, Analyst, Ladenburg: Yeah. Great, Tara. Hi. Thanks for the question. I’ll ask David to sort of give you more information about why the 45-60, what we’re actually seeing, and then how we expect that to evolve over time. David.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. Hi, Tara. This is David. In terms of the time to treat 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. The good news, as you know, is that we have very broad coverage across Medicare, Medicaid, and commercial lives. Anytime 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. As Liz commented, there’s also, because it’s a new therapy, approvals needed to use the drug. While physician interest is strong, there are a number of administrative things that we need to work through. We do expect that 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 dose. I think on your second question on remittance, we have paid claims now. On average, I think what we have experienced in terms of what our practices, our customers have told us, is that it does take a little longer during the miscellaneous J code. That is playing out as we anticipated. Thanks for the question.

Aidan Huzinov, Analyst, Ladenburg: Yeah, I guess so. Only other thing, David, was how do we expect it to be in Q4 and then going into Q1?

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. Thank you, Liz. We expect the same dynamic to play out through Q4, Tara. As we turn the corner into the first half of 2026, much of that dynamic will start to wane, but it’ll take some time. We do see gradual improvement across all those measures during the first half of 2026.

Tara Bancroft, Analyst, TD Cowen: Okay. Very helpful. Thank you so much.

Speaker 1: One moment for our next question. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is open.

Paul, Analyst, Guggenheim Securities: Hey, good morning. It’s Paul on for Michael. Thanks for taking our question. For Zesturi, just wondering how much visibility you have into physicians who are waiting for the permanent J code to kick in on January 1 to begin submitting those patient enrollment forms. Are there any qualitative metrics you could share on feedback from those docs, or is there a way to quantify the sort of pent-up demand that’s maybe being held up until the J code is effective?

Aidan Huzinov, Analyst, Ladenburg: Yeah. Great question, Paul. I’ll ask David to comment and may add some commentary myself at the end. David.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. Thanks for the question. We do hear from quite a few physicians, particularly in the community setting, that they are interested in prescribing Zesturi, have identified patients, but really want to wait until January, until the permanent J code is in effect. That’s been encouraging in terms of understanding the demand and also having the transparency from the customers as to when they anticipate starting. We are going to do everything we can during the fourth quarter to make sure that they are set up so that all they need to do is really activate the patient enrollment form come January 1. It is really encouraging what we’re seeing so far.

Aidan Huzinov, Analyst, Ladenburg: Yeah. 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. 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 from Cardinal. 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." 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. To David’s point, our top priority is pulling through our patient enrollment forms, right, and getting P&T committees. That’s our number one objective. The second objective is ensuring that all of those patients and physicians who have said to us, "I have patients identified, and 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. That’s our second priority. Priority number one is we have a lot of PEFs, as we’ve said many times.

The top of the funnel is actually very strong, and it is just our ability to pull it through. That has got to be our number one objective. Hopefully that helps, Paul, to provide some extra color.

Paul, Analyst, Guggenheim Securities: Great. Thank you very much.

Speaker 1: One moment for our next question. Our next question comes from Kelsey Goodwin with Piper Sandler. Your line is open.

Kelsey Goodwin, Analyst, Piper Sandler: Oh, 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? 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 45-60 days later? Thank you.

Aidan Huzinov, Analyst, Ladenburg: Oh, 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 45-60 days later. A great question. I’ll ask David to sort of answer your first question.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. On your question around the trend of enrollments, we are seeing very steady demand or steady growth in enrollment forms month over month. 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. We are very encouraged by that demand. As we mentioned, we’re at that point where on some weeks, we’re actually equal to or greater than Gemyto. It gives you a sense that we’re crossing an inflection barrier there.

Aidan Huzinov, Analyst, Ladenburg: Yeah. The only other thing I’ll say about the PEFs without giving the actual number is, it’s very strong, right? If our 60 days was 30 days or was three weeks, then you would obviously see a very different revenue number. Suffice it to say that October revenue that you’ve seen versus Q3, we’re seeing the same trend in patient enrollment forms. Look, we don’t give the number because it’s a very clunky number, and some fall out, and then it’s just too much. The number of a patient enrollment form, a patient has been identified. The other good news is that PEFs, we don’t get PEFs for everybody. On top of the PEFs, there’s revenue that comes in through hospitals. 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. We see that on just still Gemyto today. You’re never going to get 100% of those. Kelsey, to say it’s healthy is, I think it’s very healthy and so 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 a patient has been identified.

Kelsey Goodwin, Analyst, Piper Sandler: Perfect. Thanks so much. Congrats again.

Aidan Huzinov, Analyst, Ladenburg: Thank you.

Speaker 1: One moment for our next question. Our next question comes from Raghuram Selvaraju with H.C. Wainwright. Your line is open.

Paul, Analyst, Guggenheim Securities: Thanks very much for taking my questions. 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. 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 the active J code, will the lag time be reduced from 45-60 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 timeframe? 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. Obviously, you’ve announced the three-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 position to file the UGN-103 NDA. Thank you.

Aidan Huzinov, Analyst, Ladenburg: Yeah. Thanks, Ram. I’ll ask David to answer the first question, and then Mark will comment on the FDA.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: 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 three parts, right? There is the benefit investigation, which often entails a prior authorization. There is the initial site setup. It is to make sure that the actual site can order the product and that they are trained. And then, of course, as Liz mentioned earlier on, we want to make sure that they have permission. While physicians are interested in using it, they have to make sure that they have permission, whether it is 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 are onto the second patient.

You can imagine a lot of that starts to ease. 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’ll just be something that we continue to work through. The key to that is, 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. 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. When you add that to the overall operational readiness that we’ll have, we do anticipate that overall adoption can accelerate. The final point I’ll make is to our comments. We have been actively setting up sites of care, and that just means while they may not have treated a patient, they are operationally ready to order Zesturi.

Because we got out ahead of that, we realized that’s going to be important for the first half of 2026. We do feel good that we’re laying a good foundation in terms of supporting broader adoption.

Aidan Huzinov, Analyst, Ladenburg: Yeah. The only thing that I’ll add to that, Ram, is right now with Gemyto. It takes us—it’s about two to three weeks, right, depending on the patient. We expect to get similarly there. I do agree with David that it’s not going to happen January 1, right? It’s not a flip of a switch because the J code is just one component of why it takes the 45-60 days. You’ll see that improve over time, but it will take some time to get there. We will eventually get below 30 days. Mark, maybe comment on the 103.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. Ram, thanks for the question. Our expectation is, as we’ve previously announced publicly, that we’d submit in 2026 with expectation of approval in 2027. 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. We would submit, and then, as we have done previously in a number of applications, update during the submission process. That’s probably what we’d be looking at with 103 as well.

Paul, Analyst, Guggenheim Securities: Thank you.

Speaker 1: One moment for our next question. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi, Analyst, Goldman Sachs: 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 Gemyto currently is in the timeframe of 2026, or will that be something that’ll take a little longer? Any color on that would be helpful. 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 2026 just at the current run rate, or 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.

Aidan Huzinov, Analyst, Ladenburg: Yeah. Thanks, Paul. David can answer the first question and then turn it over to Chris to talk about the cash position. So, David.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Hi, Paul. In terms of your question around getting the time to new patient start equal to that of Gemyto, one of the things we’ll be tracking very closely, and we’re putting in a lot of extra effort, obviously, to accelerate. 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. 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.

Aidan Huzinov, Analyst, Ladenburg: The short answer is yes. We’ll get there in 2026.

Paul Choi, Analyst, Goldman Sachs: Okay. Great. Thanks, Liz.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Paul, on cash. As you saw, we have a little over $127 million in cash. We are well-positioned to be able to deliver on our core priorities, the Zesturi launch, and with the expectations around revenue growth, and based off our current operational plan, we continue to believe that we do have cash to profitability. We will continue and remain disciplined in terms of how we think about and be opportunistic regarding future capital needs.

Paul Choi, Analyst, Goldman Sachs: Okay. Thank you.

Speaker 1: One moment for our next question. Our next question comes from Leland Gershell with Oppenheimer. Your line is open.

Leland Gershell, Analyst, Oppenheimer: Thank you for this update and for taking our question. 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 the Zesturi early launch, could you comment on kind of the ratio of community uptake versus institution? 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 somewhat of a rise in community demand as you’ve progressed in the first couple of quarters? Thank you.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Hey, Leland. Thanks for the question. Launch to date, we’re seeing approximately 35-40% of our patients treated in the community and roughly 60-65% in the hospital setting. As we have outlined even prior to launch, a lot of the HCPs are going to find it advantageous to treat in a hospital outpatient setting just because of the economics. We are 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. Hopefully, that gives you a little bit of color.

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.

Leland Gershell, Analyst, Oppenheimer: Thanks. Again, early days, but. I’m not sure if you—I don’t think you would comment on this in the prepared remarks. Can you just give us some color on what the overlap is in historical Gemyto users and their interest in Zesturi versus what may be untapped, previously untapped urologists and their interest in Zesturi? Thank you.

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. I think with Gemyto, it was a little bit heavier in the institution. Today, with Gemyto, it is probably half-half, 50/50. 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.

Aidan Huzinov, Analyst, Ladenburg: No, but I think what he’s asking is, of the Zesturi, people are using Zesturi. How many of those are Gemyto users? A lot of them are, Leland. A lot of our initial usage of Zesturi has been with Gemyto users. The good news is that we also are seeing some new physicians using Gemyto because we are going in to talk about Zesturi. As we have talked about before, with the expansion of the sales organization, we are seeing more doctors, and we have seen this reverse halo start to generate some demand for Gemyto in physicians that had not seen it before. To your point, absolutely, some of our first prescribers have been Gemyto users, but not all of them. Definitely those familiar with Gemyto, and we expect that to continue and the halo to continue into 2026.

Paul, Analyst, Guggenheim Securities: All right. Thank you, Beth.

Speaker 1: One moment for our next question. Our next question comes from Aidan Huzinov with Ladenburg. Your line is open.

Aidan Huzinov, Analyst, Ladenburg: Hi. Thanks so much for taking our questions. I got a couple. Could you remind us how long it usually takes for a patient to schedule a repetitive TURBT surgery? If those are the same urologists, do you think they have more financial incentives to run another TURBT surgery or administer Zesturi?

Yeah. Great question, Aidan. David, you want to?

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: Yeah. Thanks for the question. In terms of scheduling a TURBT, what we generally hear from our customers is it takes them four to six weeks to actually schedule one. With respect to the alternative of using Zesturi, if they choose to administer Zesturi, it can be roughly right now. They’ve got to schedule the patient in. Again, it’s basically based on the patient’s desire and their schedules. From a financial perspective, one of the things that we’ll think about is a physician’s fee for doing a TURBT is going to be in the couple of hundred dollar range, and that is excluding any sort of fee for the actual hospital.

One of the things that we have been asked a lot in terms of the financial economics of Zesturi that our market access team can speak to is that there is ability to be positive from administering Zesturi. Importantly, because it can be done by a nurse, it does allow the urologist to actually attend to other matters. Hopefully, that gives you a little color in terms of the time to schedule and also the economics.

Aidan Huzinov, Analyst, Ladenburg: Thank you. Very helpful. Another question I have on UGN-501, next-generation oncolytic virus. Can you help us understand the competitive landscape for UGN-501, and what are the possible parallels with the CG oncologist story?

Liz Barrett, President and Chief Executive Officer, UroGen Pharma: 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. This falls into the asset class of developed for high-grade disease, high-grade non-muscle-invasive cancer. The thing about the 501 asset to keep in mind, although obviously we are in IND enabling stage and anticipate phase one in 2026, 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 anti-tumor immune response. 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. 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. 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. Something for the future to think about.

Aidan Huzinov, Analyst, Ladenburg: Thank you. Very helpful.

Speaker 1: 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.

Aidan Huzinov, Analyst, Ladenburg: 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 Zesturi, deliver on Gemyto revenue, and importantly, advance our pipeline. Again, thanks to everybody for joining, and we look forward to keeping you guys abreast. Thanks.

Speaker 1: Ladies and gentlemen, this does conclude today’s presentation. We thank you for your participation. You may now disconnect and have a wonderful day.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.