UroGen Pharma Ltd. (URGN) Q3 2026 Earnings Call Transcript

Operator: Thank you for standing by, and welcome to UroGen Pharma's Third Quarter 26 Earnings Conference Call. Currently, 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 1-1 on your telephone. To remove yourself from the queue, you may press 1-1 again. I would now like to hand the call over to Vincent I. Perrone, Senior director of investor relations. Please go ahead.

Vincent I. Perrone: Thank you. Good morning, everyone. And welcome to UroGen Pharma's Third Quarter 26 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 09/30/2026. The 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 doctor Mark Schoenberg, chief medical 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 Zosturi and Jelmyto, our ongoing and planned clinical trials and nonclinical studies, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data regulatory filings and decisions, the importance of Zosturi's growth for UroGen's long term strategy, anticipated benefits of our strategic collaboration with IntraGel Therapeutics, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals, and 2026 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 will now turn the call over to Liz Barrett, Chief Executive Officer. Liz?

Elizabeth A. Barrett: Good morning, and thank you for joining us today. We delivered another quarter of strong execution. With Zosturi generating $68 million in net product revenue, representing a 35% sequential quarter over quarter growth. More importantly, the underlying commercial trends continue to strengthen. With increasing repeat utilization broader physician adoption, and continued expansion into community practices. Together, these trends reinforce our confidence that Zosturi is scaling successfully establishing a strong foundation for sustained growth. This momentum reflects the story's differentiated value proposition. As the first and only FDA approved medicine for adults with recurrent low grade intermediate risk non muscle invasive bladder cancer Zosturi offers a primary surgery free alternative for disease that historically has been managed through repetitive surgical interventions. We believe this differentiated approach provides patients an opportunity to have more recurrence free and treatment free living. And is increasingly changing how physicians think about treating these patients. Turning to the operating metrics, we have been tracking as of 09/30/2026 we had over 1.5 thousand activated accounts. With a substantial foundation of activated accounts now in place, our commercial team's focus is shifting toward driving utilization within these practices converting new prescribers into repeat users, and expanding adoption across the broader physician community. Unique prescribers grew to 662 compared with 452 in the second quarter. While repeat prescribers increased to 31 compared to 204 at the end of the prior period. Repeat prescribers now represent 50% of total writers, up from 45% in the second quarter and 40% in Q1. We continue to view repeat utilization as 1 of the strongest indicators of sustained adoption. As physicians gain experience with Zosturi's clinical profile, reimbursement process, and administration workflow, they become increasingly comfortable incorporating the product into routine practice. We believe this growing familiarity and confidence will deepen utilization over time. We continue to see encouraging adoption trends across community urology practices with a site of care mix remaining relatively consistent with the second quarter, and community practices accounting for the majority of the utilization. This reflects the progress we have made in expanding our presence in the community setting, where approximately 70% of our addressable market resides. We believe continued growth and deeper penetration within these practices represent a significant opportunity to sustain momentum as the launch continues. We are also expanding demand generation efforts through physician education, peer to peer programs, and patient awareness initiatives. Many patients living with recurrent low grade non muscle invasive bladder cancer remain unaware that a surgery free treatment option is available. We believe direct to patient efforts can encourage more informed discussions. Between patients and providers, while peer to peer programs may help physicians gain confidence from colleagues, with firsthand experience using Zosturi. Together, we expect these investments to support broader adoption and help realize the significant commercial opportunity ahead. During the third quarter, we did observe some summer seasonality for a short period but bounced back quickly as reflected by the strong quarter results. Importantly, continued growth in new prescribers and patient starts more than offset these seasonal dynamics, reinforcing the underlying strength of demand. Looking ahead to the fourth quarter, we remain mindful of the typical holiday-related slowdown but continue to see expanded adoption and utilization and expect quarter over quarter revenue growth. Turning to Jelmyto. Net product revenue was $21 million in the third quarter. Compared with $22 million in the second quarter. Importantly, this included a 1-time unfavorable gross to net adjustment of approximately $1.5 million related to the CMS discarded drug provision true up. Are also seeing increased competition for eligible patients from ongoing clinical trials in the low grade UTUC space. Including our own 104 Phase 3 trial, which has created some headwinds for patient starts. Nevertheless, Jelmyto remains an important surgery free treatment option for patients with low grade UTUC and continues to support our broader commercial infrastructure. Turning now to the pipeline. We achieved an important milestone with UGN-103, our next generation investigational therapy for adults with recurrent low grade intermediate risk non muscle invasive bladder cancer. Following our NDA submission in August, the FDA accepted the application for review in October, and assigned a PDUFA goal date of June 14, 2027. Representing another significant step toward potential approval. We view UGN-103 as a central component to our longer term strategy. It is designed to build on the clinical and commercial foundation of Zosturi while offering potential manufacturing and operational efficiencies. That can further strengthen our business over time and opportunities to expand into other non muscle invasive bladder cancer populations. Importantly, our newly issued patent now listed in the FDA's Orange Book, is expected to provide patent coverage into July 2044 for both Zosturi and, if approved, UGN-103. For the treatment of low grade intermediate risk non muscle invasive bladder cancer without a TURBT. We believe this further strengthens the long term revenue potential for both products. Beyond the initial indication, our planned expansion into high-grade NMIBC with UGM-103 represents an additional opportunity to broaden our reach and address unmet needs in uro oncology. As part of our life cycle management strategy for UGN-103, we also plan to initiate a nonregistrational trial evaluating its use as an adjuvant therapy in the newly diagnosed intermediate risk population. Mark will discuss the regulatory and clinical plans in greater detail shortly. Finally, in August, we announced a strategic collaboration, licensing option, and equity investment agreement with IntraGel Therapeutics, Representing an exciting expansion of our innovation and growth strategy. The agreement provides access to Intragel's biodegradable sustained release platform and gives us the opportunity to develop up to 3 new oncology products using this technology. While also securing an exclusive option to acquire worldwide rights to their cisplatin gel based Phase 2-ready therapy for advanced head and neck cancer. Importantly, this collaboration expands our capability beyond Euro 1 oncology. While remaining aligned with our core expertise on localized sustained drug delivery. We believe it creates meaningful opportunity to broaden our pipeline advance innovation across additional solid tumors, and supports future growth. In closing, the progress we made through the first 9 months of 2026 has strengthened our confidence in the opportunity ahead. Zosturi continues to scale. Our next generation programs are advancing toward important milestones, and we are investing in a pipeline that we believe can support multiple drivers of future growth. We are building a company positioned for sustained through commercial execution, life cycle expansion, and continued innovation. With over $90 million in cash on the balance sheet at quarter end, we remain confident in our ability to reach profitability with our existing capital resources. Above all, our strategy remains grounded in our commitment to patients and the belief that they deserve better treatment options. We see tremendous opportunity to build on our success in uro oncology expand our reach into additional specialty cancers, and create meaningful long term value for our shareholders. With that, I will turn the call over to Mark for a clinical update. Mark?

Mark Schoenberg: Thank you, Liz, and good morning, everyone. I would like to begin by building on Liz's discussion on how Zosturi adoption is evolving, particularly as physicians gain experience and increasingly incorporate the product into routine clinical practice. From a clinical perspective, what makes Zosturi particularly compelling is that it offers a fundamentally different approach to managing adult patients with recurrent, low grade, intermediate risk, NMIBC. It is the only FDA approved primary therapy in this setting. And unlike other therapies, currently in development, it does not require TURBT as part of the treatment regimen. For patients who have historically faced repeated surgeries under general anesthesia, and prolonged treatment courses the ability to achieve durable disease control without another TURBT represents a meaningful advancement. This distinction becomes increasingly important as the treatment landscape evolves. Many investigational therapies are being evaluated as adjuvant treatments following TURBT, often requiring additional induction and maintenance therapy over extended periods. Zosturi, by contrast, offers a primary surgery free approach with a defined 6 week treatment course and no maintenance. From a clinical perspective, we believe the ability to deliver durable disease control while reducing the need for repeated surgical interventions and prolonged treatment courses represents a meaningful advantage for both physicians and patients. 1 of the more encouraging trends we are seeing is how physician confidence grows with experience. Physicians often begin by treating a small number of patients, And as they observe clinical benefits, and see how readily Zosturi integrates into practice, they begin considering it for a broader range of appropriate patients. Familiarity with the reimbursement process provides additional reassurance particularly for practices less experienced with buy and bill therapies. In some practices, that experience is also being shared among colleagues. Supporting broader adoption across the group. From my perspective, this is an important indication that Zosturi is becoming more firmly integrated into the management of recurrent low grade intermediate risk NMIBC. Turning briefly to Jelmyto, We recently announced the publication of final 5 year follow-up results from UroGen's Phase III OLYMPUS trial in therapeutic advances in urology. Further reinforcing the long term durability of response with Jelmyto in patients with low grade UTUC. Among all 41 patients who achieved a complete response, the median duration of response was 47.8 months. Of the 20 patients who entered the long term follow-up study, 75% remained event free at the last assessment with a median follow-up of 53.3 months. Notably, the median duration of response had not been reached in this subgroup, and no progression in the high grade disease was observed. These findings further reinforce the clinical value of Jelmyto as a kidney sparing, surgery free, treatment option. Turning now to our clinical development programs. As Liz mentioned, the FDA accepted our new drug application for UGN-103 and assigned a PDUFA goal date of June 14, 2027. This represents an important milestone as we advance our next generation mitomycin formulation toward potential regulatory approval. The application is supported by results from the phase 3 Utopia trial which are generally consistent with the 3-month complete response and 6-month duration of response observed with Zosturi in the pivotal ENVISION trial. From a clinical perspective, the consistency of the results is highly encouraging, and supports our confidence in the potential of UGN-103 to preserve the durable treatment profile established with Zosturi. We plan to supplement the submission with updated 12-month duration of response data as they become available, and we will share those results in a future announcement. If we receive FDA approval in 2027, we intend to apply for a permanent J code by the July 1 quarterly submission deadline. Which would position us for a January 1, 2028 effective date. We anticipate initiating a full commercial launch in 2028, assuming receipt of the permanent J code. Beyond the initial indication, we are advancing a broader clinical development strategy for UGN-103 beginning with high grade NMIBC. High grade NMIBC presents a distinct clinical challenge. With greater risk of recurrence and progression, and a continued need for effective bladder preserving. Options. Following productive discussions with the FDA, we plan to initiate a randomized phase 3 trial in the fourth quarter evaluating UGN103 as adjuvant therapy in patients with recurrent papillary only, high risk non muscle invasive bladder cancer who have previously received BCG therapy. Study will compare TURBT followed by either UGN-103 or gemcitabine induction and maintenance therapy. We believe this study represents an important opportunity to evaluate whether sustained local delivery of mitomycin in RT gel can provide a meaningful clinical benefit in a more challenging patient population. As part of our life cycle management strategy for UGN-103, we also plan to initiate a nonregistrational trial evaluating it its use as adjuvant therapy in the newly diagnosed intermediate risk population. This study will allow us to further characterize the safety and clinical activity of UGN-103 in an additional treatment setting and inform our broader development strategy. Turning to UGN-104, our next generation mitomycin formulation for low grade UTUC, The phase 3 trial continues to progress. And we expect to complete enrollment by the end of the year or in early 27. Additionally, UGN-501 our investigational next generation oncolytic virus for high grade NMIC, received FDA clearance of our IND in July, enabling us to initiate our Phase 1 clinical trial. First patient has now been dosed, and we anticipate initial clinical data in 2027. Our Phase 1 study will evaluate intravesical administration in an aqueous formulation with a primary focus on safety, tolerability, and dose selection. While also looking for early evidence of clinical activity. In parallel, we are developing a formulation incorporating our RTGL technology. We believe sustained local delivery may offer several potential advantages, including prolonged exposure at the tumor site, and the opportunity to explore whether a pretreatment requirements such as a detergent wash dosing intervals, or dose levels can be optimized. These potential benefits will require further evaluation as development progresses. UGN-501 represents an important opportunity to expand our therapeutic capabilities beyond chemotherapy. Initially within urothelial oncology, potentially into other solid tumors. Finally, I would like to briefly expand on the strategic collaboration with IntraGel that Liz referenced. Our RTGel technology has been demonstrated to provide sustained local drug exposure within the urinary tract. However, because RTGel is not biodegradable, its applications are generally best suited to anatomical environments where formulation can be naturally voided. IntraGel's SR gel platform offers a complementary approach. It is a biodegradable sustained release platform designed to maintain high concentrations of a therapeutic agent directly at the tumor site following a single administration while limiting systemic exposure. We believe this technology complements our existing expertise in localized drug delivery broadens our innovation capabilities beyond RTGel. The first clinical application of that platform is a cisplatin gel based intratumoral injection, a Phase 2-ready investigational therapy for advanced head and neck cancer. Early Phase 1b data presented at ASCO demonstrated encouraging tolerability, low systemic cisplatin exposure, and preliminary evidence in antitumor activity, including in patients with cisplatin resistant disease. While these findings remain preliminary, they provide an encouraging foundation for further clinical development. This collaboration expands our pipeline beyond uro oncology while remaining closely aligned with our scientific expertise in localized sustained drug delivery. Which we believe creates meaningful opportunities for further innovation. And with that, I will turn the call over to Christopher to review our financial results. Christopher?

Christopher Degnan: Thank you, Mark, and good morning, everyone. Total revenue was $89 million in the third quarter of 26 compared with $27.5 million in the third quarter of 25. This increase was driven by the continued commercial launch of Zosturi. Research and development expenses were $26 million in the third quarter of 2026 compared with $14 million in the same period last year. The increase was primarily attributable to an increase in UGN-103 and UGN-104 clinical development costs the PDUFA fee related to the UGN-103 NDA submission, and increased development costs related to UGN-501. Selling, general, and administrative expenses were $47.2 million in the third quarter of 2026, compared with $37.6 million in the same period last year. The increase was primarily attributable to increased commercial spend related to the ongoing Zosturi launch. We recorded noncash financing expense related to our prepaid forward obligation to RTW Investments of $4.5 million in the quarter, compared with $4.6 million in the third quarter of 25. Interest expense on our long term debt was $4.8 million compared with $3.4 million in the same period last year. The increase in interest expense was primarily attributable to the $75 million of additional borrowings drawn in the first quarter of 26 in connection with the Pharmakon refinancing. Offset by the lower interest rate. Net loss in the third quarter was $1.5 million or $0.03 per basic and diluted share compared with a net loss of $33.3 million or $0.69 per basic and diluted share in the third quarter of 25. As of 09/30/2026, we had $90.5 million in cash, cash equivalents and marketable securities. I would highlight that our cash burn in the quarter included the 1-time $4.8 million PDUFA fee associated with the UGN-103 NDA submission and a $4 million investment into IntraGel related to our strategic collaboration. With our current cash, cash equivalents and marketable securities, together with $117 million in accounts receivable as of 09/30/2026, we remain confident in our ability to fund the business through profitability with our existing capital resources. Based on our current expectations, we anticipate achieving profitability and generating positive cash flow in the fourth quarter of 26. Turning to guidance. We are updating our full year Jelmyto net product revenue guidance to approximately $90 million This primarily reflects the $1.5 million unfavorable onetime gross to net adjustment Liz mentioned together with headwinds from ongoing competitive clinical trial enrollment in low grade upper tract urothelial cancer, that has affected Jelmyto patient starts. As we have noted previously, we are not issuing full-year Zosturi guidance, while the launch is still in its early stages. We are maintaining our full year operating expense guidance of $260 million to $270 million including $20 million to $24 million of noncash share based compensation. We now anticipate operating expenses to land toward the upper end of the guidance range. This guidance reflects our investment in Zosturi healthcare professional education and patient awareness, start up activities for the UGN-103 high grade trial, and development activities to explore UGN-501 with our RTGel technology. That concludes our prepared remarks. We will now open the call to questions.

Operator: Thank you. To ask a question, you will need to press 1-1 on your telephone. To remove yourself from the queue, you may press 1-1 again. Our first question comes from the line of Leland Gershell of Oppenheimer. Your line is open, Leland.

Leland Gershell: Great. Good morning, everyone. Thanks for taking our questionss. Just 2 from us. First, we just want to drill in a bit, Mark, on your comments about the sort of the type of patient who would be the go to for Zosturi versus another TURBT. It sounds like, you know, given the data, Zosturi can treat, a fairly broad range of such patients, but perhaps urologists are a bit more narrow. Could you sort of share with us kind of what that looks like in terms of their preference now versus what the data have shown? And then I will have a follow-up.

Mark Schoenberg: Sure. So thank you, Leland. What we are seeing urologists do right now is as Liz mentioned, and as I think, has been said on multiple calls before, this 1 is to get familiar with the drug. The data support using this in patients with a recurrence or maybe 2 recurrences In fact, that is what we studied. But truthfully, the drug is appropriate for a patient who has recurred after standard of care with intermediate low grade intermediate risk low grade disease. So in terms of the appropriate population, it would be appropriate for patients who have recurred after standard of care, which would be TURBT, and then based on guidelines possible use of intravesical postoperative therapy. So anybody who is recurred with low grade disease could receive the drug. But, again, what we are seeing is the doctors are getting familiar, so they are using it in patients who have had more than a couple of TURBTs, and I would imagine what will happen is as they gain greater familiarity with this, they will move it to earlier in the line of therapy for this population. Liz and Christopher may also want to have comments based on their understanding of the commercial launch.

Leland Gershell: Thanks, Leland. Sounds like sounds like that is the answer. Okay. Thank you. And also, just quite curious, given that 3Q could have seen some seasonal weakness or softness in terms of visits and procedures. Just wondering if there is any way to either quantify or give color around, you know, how much that could have impacted Zosturi despite, obviously, the continued growth?

Christopher Degnan: This is Christopher. So just on the. it is it is tough to quantify. I mean, what we did see with seasonality, as Liz mentioned, it generally impacted. You know, if we just look at the pace of new patient enrollment forms during the several months, But, you know, the momentum from, you know, Q2 patient enrollments and therefore, you know, patients on therapy coming into the quarter, plus just the continued growth in new and repeat prescribing more than offset, you know, those dynamics, which contributed to another strong quarter in terms of revenue. So it is really hard to quantify, you know, the true impact there. But, you know, we said, we saw a bit of it there.

Elizabeth A. Barrett: Yeah. Hi. it is Liz. And I apologize because I am not in the room with the team. And so I want to go back Leland, to your previous question, though. What. When Mark answered, I could not get off of mute fast enough. but I will answer that question first. I do not think that if you think about pure revenue that it impacted it that greatly because of the way we bounced back pretty quickly. So because past and, you know, new patient starts are fairly variable anyway, I do not think we lost a lot of patients, if that makes sense. So while we did see, you know, the a leveling of patient enrollment forms, you know, for a couple of weeks they. It came right back. And because it takes several weeks anyway for these patients, my. I am I would say that it did not have a huge impact on revenue. So you know, so, you know, maybe minimal, but not huge. Going back to Mark's, though, I wanna be really clear We actually are seeing in the claims database, we are seeing usage across the board. I think what we have said from the beginning is we expected that physicians will start with their more heavily pretreated patients. But they very quickly get to all of their patients. And we have seen that in the in the claims database. Where we have seen the shift to physicians using it after 1 and after 2. And so it is a pretty even, you know, group of patients, like I said, after 1, after 2, yeah, you see the ones after 3, after 4, after 5. We have got patients, as we have talked about before, after 20 and after 40 TURBTs. So it is across the board, but any physician's gonna likely start with their more heavily pretreated patient. But it is adopted across the board. And we are still seeing that, and that is what we are hearing also from physicians as we are out there, talking to physicians. So hope that helps, and my apologies for being delayed. Yeah. Absolutely. Thank you very much. Very helpful.

Operator: Thank you. Our next question comes from the line of Tara Bancroft of TD Cowen. Please go ahead, Tara.

Tara Bancroft: Hi. Good morning, and congrats on this great quarter. I know that it is challenging to predict going forward, but I am curious even based on your years of experience with Jelmyto, if maybe we should expect these types of trends that you saw in Q3 to be the norm going forward each year or maybe if there were any effects that are unique to the early stages of the launch, maybe you could tell us about that. And then also looking forward to Q4, if you maybe talk about any impacts that we can expect then that could potentially offset demand growth just what to expect there in the near term and long term? Thanks.

Christopher Degnan: Yes. So Tara, this is Christopher. I will start and then Liz, you can you can jump in. Just in terms of the Q3 dynamics, I think just Jelmyto is not a great analog here. They are just mainly, you know, 1, just the sheer number of patients right, in terms of you know, Zosturi market opportunity is much larger. And so coming into the quarter, we anticipated some seasonality as we talked about. But, you know, we are we are confident that just given the number of available patients that you know, would more than offset, you know, any potential seasonal impact, which we which we saw. So I think this is part of it as we think about Zosturi guidance. Wanted to get through some of these quarterly dynamics just to better understand kind of the magnitude on what this looks like. So hard to predict, you know, exactly what this will look like on a recurring basis, but still in the early stage of launch. Think that there is there is obviously opportunity for continued quarter over quarter growth momentum here. Coming on your point then around Q4, you know, we do continue to expect to see, you know, quarter over quarter revenue. We are encouraged by the trends we are seeing in terms of the number of new prescribers within Q3. 3, as well as the percentage of those prescribers who become repeat writers. So, you know, you know, we are mindful, as Liz mentioned on her. in her prepared remarks that, there could be some typical holiday related seasonality in Q4, We have, you know, we did see it a bit even in the early stages with Zosturi launch. Last year where the weeks of the holidays, you know, you can have fewer patient starts and doses shipped. But overall, you know, we do expect continued growth, and we are comfortable with where consensus sits for the full year for Zosturi.

Tara Bancroft: Okay. Sounds great. Thanks.

Operator: Thank you. Our next question comes from the line of Raghuram Selvaraju. Of H. C. Wainwright Company. Your line is open. Raghuram.

Analyst: Thank you. Thank you so much for taking our questionss. I was just wondering if we could maybe start with Jelmyto, if you anticipate that there is likely in the long run to remain some incremental quarter over quarter growth potential for the product, or if at this juncture you are seeing any indications of market saturation?

Elizabeth A. Barrett: Hey, Christopher. I will take that. Hi, Ram. it is Liz. I think what we are doing in I think it is fair to say that Jelmyto, like every other product that I have ever been familiar with, is promotion sensitive. And so what we are doing is we are developing sort of a strike team to go into sort of our heavy users of Jelmyto to ensure that we maintain that promotional you know, the promotional share of voice in there. Having said that, we really did get hit with the clinical trials I have to be honest with you. I am very surprised that you have got about 4 or 5 companies right now doing studies in, you know, this low grade UTUC space. With a very limited patient population, and our heavy users are also clinical trial sites. So if we sort of annualize, you know, if you annualize it, it is several million dollars of revenue Not saying that we would have gotten all of that, but if you think about it. So I guess my point is gonna be yeah, once we get past this hump, now there is still gonna be clinical trials in 2027, so you will still continue to have that headwind there. But I do think that there is opportunity to get back on track with Jelmyto in the sense of our trial will be fully enrolled. Our UGN-104 trial. So as we. that is you know, 1 that will be will be done. And as they start end, I think you will see that. And then I do think that adding some promotional muscle back behind Jelmyto's specifically. Look. We prioritized Zosturi. We made that decision and, you know, we knew that there was a potential that, you know, that Jelmyto would have challenges. I think our hope was that with the incremental physicians, you would see some of that come back But, you know, and as we talked about with the $1.5 million hit from there. So we have had a few headwinds there, but still think that there is a lot of opportunity on Jelmyto. But what we have said, you know, it is it is likely to be around a $100 million opportunity, as we get into UGM-104. There may be some opportunity there. That could that could draw that a little bit higher than that. But, you know, we have always talked about the fact that we felt like you know, within that 100 to 150 range is likely to be where Jelmyto will be long term.

Analyst: And then with respect to the Zurich franchise. Just 2 items here. I was wondering if you could comment on the prospects regarding, kinetics behind expansion of the total complement of activated sites of care and if you anticipate that there might be potential to see an inflection point on that front, either before the end of this year or sometime during the first half of 27? Also, if you could maybe comment on the trend with respect to percentage of repeat prescribers as a percentage of the total the total prescribers going forward. And if you anticipate that there might be the likelihood of that percentage ticking up meaningfully above the 50% level, And with respect to the 103 application if there has been any indication from the reviewers of that application that they wanna see additional controlled data or if really what they are looking for is simply confirmation of the durability of response rate at the 12-month cutoff. And then lastly, I just wondered if you could briefly comment on what you are looking for to trigger the exercise of the option in the IntraGel agreement on their cisplatin candidate. Thank you.

Christopher Degnan: Christopher, you wanna start? Yeah. So let's. I will start with the activated sites and a little bit around the prescriber rate, and then maybe turn it over to Mark on the 103 question and then to you for the IntraGel piece. So just, Ram, on activated sites, you know, we. We have done a good job of you know, building a substantial foundation there in terms of activated sites. And we will continue to add them, and it can be a bit lumpy as you have seen. I mean, we added quite a few activated sites in Q2. Maybe fewer in Q3. But the team's really been focused on you know, driving and converting those accounts into prescribers. And so, you know, I think really the focus has been should be the focus in terms of KPIs is looking at our new prescribers as well as looking at what that, you know, repeat utilization rate is. And we still believe there is substantial opportunity here to expand adoption within the existing account base that we have already set up. But we will continue to add, you know, accounts as we go. In terms of the repeat prescriber rate, again, that. that is a rate that, you know, we look at because as, you know, Mark mentioned, you know, typically what urologists are doing is trying Zosturi in 1 or 2 patients understanding kind of the reimbursement dynamics how it incorporates in their operational workflow, looking at clinical experience, and then, you know, starting it to use them on additional patients. And so you know, looking at how that repeat prescriber base evolves over time is a really important focus for us. And so part of it is how fast you fill the top of the funnel in terms of new prescribers. Which we are really pleased with how that is tracking in terms of performance in Q3. But then also, you know, expanding that repeat writer basis. So we would expect number of repeat writers as they get experience with Zosturi to continue to grow as well.

Mark Schoenberg: Ram, thanks for the question about 01/2003. We have not received any additional information from the FDA suggesting that they want comparative data or anything other than what we had originally proposed, namely complete response, safety, and then, obviously, the update with the 12-month durability data. So we are still on track with our original proposal, and there has not been any change in that to date.

Elizabeth A. Barrett: Yeah. And, look, I am just gonna comment a little bit more around your question around can we. Can it accelerate, and can you have an inflection point I do not think you will see an inflection point in the next few quarters. Right? I think there is 2 things, and we have talked about this a little bit before, that could cause an inflection. 1, we have talked about DTC. We are going all in on DTC. In 27. That takes time, so it is not likely to be, you know, before kinda mid-year 2027. And I do think that can be a real driver and inflection point for us. And the other is to your point, you have gotta get a lot of large group practices and these community practices where most patients are to really implement kind of a bladder line of service. What do I mean by that? And, you know, when they talk a lot about, you know, patient navigators, having these bladder champions where they go when they are actually actively looking for patients. And I think when you do get to enough of a breath, of those types of practices, then you can see kind of the inflection point. You know, we always. We think about bladder cancer every day. But urology practice is only about 20 percent of their practice. Right? So they have got a lot of other things on their mind. So these types of things take time. In all of our conversations with these large practices, they get not only the clinical benefit but they also get the practice benefit. To doing this. And so we are we are hearing. We continue to hear very positive feedback about their intention to use Zosturi and their intention to continue to drive that depth of usage in their in their practice. And today, yeah, I mean, we talk about we have we have grown our number of users but the reality of it is that is still a very small percentage of the total urologist. So what is driving our revenue today? Is the depth of those users. So that is why we have to get the breadth and the depth in those. So, like I said, what is driving more today is more of that depth. And, yes, we do expect that more and more, well, more than 50% will. That will continue to grow as we you know, they are, quote unquote, repeat users. We do not see any kind of 1-and-done. And, you know, we have talked about All of our research, 100% of physicians who have used it said they would use it again. So. And we know that patients are really happy with it. So when those all things come together, you know, we have continued to. We expect to continue to see growth. On the IntraGel, basically, we need to see positive data in their Phase 2 study. And that is when we would discuss whether it makes sense for us to, to take that forward. So that is really what we would be looking at for the IntraGel. it is a similar approach and so 1 that we are quite familiar with where, you know, we like the data we have seen so far, but we need to see more data before we would decide to take an option on that. So I hope that helps, Ram.

Analyst: Yeah. Thank you very much.

Operator: Thank you. Our next question comes from the line of Kelsey Goodwin of Piper Sandler. Your line is open, Kelsey.

Analyst: Hi. This is Kristen on for Kelsey. Thanks for taking our questions. Just a couple of quick ones. So what factors are most important to drive acceleration as we move into years 2 and 3? Of the launch of Zosturi, and what is most important when trying to broaden the number of unique prescribers of unique prescribers. Thank you.

Christopher Degnan: Liz, I will start and you can weigh in. Thanks, Kristin, for the question. Liz mentioned in her prior remarks, just in terms of what could generate acceleration going forward. Think the 2 main factors that we would point to is 1, you know, patient activation. As we talked about looking to invest in that more heavily in 2027. And so patients coming in and asking for non surgical approach, we think, can contribute towards an acceleration. As Liz said, that is also gonna take some time. So we are developing that program, and we will look to roll that out in earnest in the mid part of next year. Then the other piece goes back to the protocol you know, establishment at some of these large group practices where, you know, really driving, Zosturi you know, kind of first in terms of how they think about utilization within their group practices. In terms of the unique prescriber piece, you know, look, as Liz said as well, we are we are still in the early stages of that. And so if we just think about we talked previously that you know, our broad target universe is over 8 thousand urologists. Our core target, so deciles 2 through 10, is roughly 6.5 thousand. Urologists. And through Q3, you know, we just have over 10% of those urologists having prescribed Zosturi. So there is there is plenty of opportunity for us to really continue to drive the breadth of utilization, and that is, you know, what we are focused on every day in terms of know, getting that, you know, our Salesforce out there, know, make sure they have clinical conviction, getting them to try the product. And we know urologists are a bit slower and more methodical in adopting new products. So you know, getting them out there, getting comfortable with the reimbursement profile and the operational dynamics of this is, you know, obviously, a key part of our strategy.

Analyst: Thank you. And just 1 quick follow-up. What is the split currently of Zosturi being used as a primary therapy versus an adjuvant?

Elizabeth A. Barrett: Yeah. So it is Liz. Right now. And this is. Look. Just is anecdotal and through our claims database. So it is it is. You know, just take it for what it is worth. Right? We do not have quantitative, and we do not capture that information. It looks like, over 60% is primary. And, we have seen that, increase So, again, initially, maybe some doctors said, let me do the-- I want to do the TRVT first and then come back with it. We are seeing more and more doctors being more comfortable with primary treatment. Which is what we think is what we should do, and that is what we talk about, and that is what we promote. And so think that is in the best interest of the patient. So you are seeing now, the amount of adjuvant decline to a little bit less than 40%. Great. Thank you so much.

Operator: Our next question comes from the line of Michael Schmidt of Guggenheim Securities. Your line is open, Michael.

Analyst: Hi. This is Michael on for Michael. Thanks so much for taking our questions. Just a question on the UGN-103 transition. With the plan to submit the 12-month durability data for FDA review, do you see this durability update changing the label And then, also, how long do you expect there to be an overlap between the transition from Zosturi to UGN-103 before there is a unique J-code. Thanks.

Mark Schoenberg: With respect to the durability data, obviously, the 12-month durability data will be will be in incredibly important to the label as it was with Zosturi. So it is an important update, but it will not change the timeline of review.

Christopher Degnan: And then I will refer to Christopher. So just in terms of the transition. So the plan, you know, is you know, right now with PDUFA date being mid June to submit then for the J-code by the July 1 submission date which should position us for a effective date of 01/01/2028. And then, you know, at some point during, you know, 2028, you know, we do have you know, flexibility here in terms of just given, you know, the additional IP that we have for Zosturi as well. To be thoughtful and mindful about the transition. And so our plan is, you know, in the first half of 28 then to introduce, you know, UGN-103 into the market. And there will be a period of time where both products will be available to make sure that you know, it is a seamless transition that all patients ultimately get therapy So I would expect, you know, several months over the course of 2028 for both products to be on the market. And then at, you know, 1 point where we have the majority of patients moved over, we will pull Zosturi from the market.

Analyst: Great. Thank you.

Operator: Thank you. Our next question comes from the line of Mohamad Amin Makarem of Jefferies. Hi. Thank you for taking our questionss.

Mohamad Amin Makarem: Couple of questions from us. For Zosturi, is the prior linear growth, which was, like, $15 to $20 million quarter over quarter a right framework to think about for the coming quarters, especially for 2027? And I have a question on UGN-103 for the nonregistrational study. For this adjuvant treatment in naive patients. Could it be enough to support inclusion in guidelines, or would you expect to need a larger body of evidence there?

Christopher Degnan: I mean, I will I will start with the linear, you know, growth question. And so we have said even coming into start of the year that we just given the way urologists adopt new products that, you know, we saw this more as a steady linear growth trajectory. And if you just think about the quarterly dynamic, mentioned the $20 million, which was the growth rate for absolute growth between Q2 and Q1. Think about Q1, that grew about $15 million this past quarter grew about $18 million. And so we have said, like, look, we do expect that a linear a general linear growth trajectory, but that there is gonna be some quarter to quarter variability. And so I think, you know, thinking about it in the framework of, you know, we have been growing $15 to $20 million this year, and, you know, we said, you know, we think about Q4, we expect continued growth, and we are comfortable with where full year consensus currently sits for Zosturi. So if you are trying to factor in those quarterly dynamics at play. I think you know, when we think about the trajectory in the 2027, we are not issuing guides at this point for Zosturi and have not really provided much in terms of context for 2027 outlook. But we think about a steady growth rate I think that range is reasonable. And then, you know, as you talked about, there may be opportunities to accelerate that growth rate, but in a, you know, future period. And as we think about the UGN-103 program, maybe I will turn it over to Mark just to think about how we are we are looking at that.

Mark Schoenberg: Yeah. And thanks for the question about that. So the purpose of the adjuvant trial in the newly diagnosed is specifically to provide physicians whom we already know are in some patients using Zosturi as an adjuvant and presumably would also use UGN-103 as an adjuvant in some select patients with safety and tolerability information. Remember, we primarily study patients using Zosturi, UGN-102 and UGN-103, As a primary therapy but we know that some of the doctors in the community are using primary chemoablation actually after TURBT. As an adjuvant therapy. So, again, the goal is safety and tolerability. We would obviously report any efficacy information as well as part of that trial. This is. As you noted, it is not a registrational trial, so we would not be planning on changing the label based on these data.

Elizabeth A. Barrett: I would defer to Liz as to whether or not she thinks this would impact guidelines. Yeah. I think that there is definitely will be enough information and enough data when you combine it with our ATLAS study. You know, whether we will get in the guidelines or not, you know, I do not know. You know, I cannot really comment on that, if that is not really our goal. As Mark said. The object of it the really objective is to ensure that physicians understand the data because we do not we have not generated data in that specific patient population. I think it is really important And we already know, as Mark commented, that some docs have actually already used it that way. So we want to make sure that, that there is data generated in that space, and that is the goal. And, look, if it is really, really strong data, who knows? Maybe we will go back and do a registrational study. After that. But the purpose is really to ensure that there is some data generated in that patient population, which is really the only patient population in the low grade IR space that we have not studied. And. But we would we would absolutely, you know, submit the data, both the results of this study along with our ATLAS data. You know, to and have published data around that so that, you know, physicians would have access to that. Thank you.

Operator: Our next question comes from the line of Kevin DeGeeter of Ladenburg Thalmann. Your line is open, Kevin.

Kevin DeGeeter: Maybe just 3 quick ones with regard to Zosturi kind of commercial metrics 1, can you kind of comment from an operational perspective what part of the commercial team's messaging is most effective in transitioning unique first-time users to repeat users then maybe just 2, you know, metrics as I think about 2027. You know, Any thoughts with regard to you know, headcount expansion in the commercial team, some specifically around Zosturi and, you know, what sort of impacts, the timing of you know, turning on a DTC program for Zosturi potentially in 2027? Thanks.

Christopher Degnan: Hey, Liz. I will start with the headcount expansion and timing on DTC, and then you can comment around what messaging we find is most effective. In terms of headcount expansion, you know, Kevin, we feel like we are, well positioned with the number of reps that we have out there, currently promoting Zosturi. You know, roughly, we have about 80 And then when you factor in the fact that we have field reimbursement managers, we have operations managers. We have key account directors. We have nurse educators. You know, to help support the staff and the offices around all the other dynamics that go along with the drug like Zosturi the reimbursement, the operational piece. You know, our overall customer facing footprint is about 160 people. So going into next year, we feel like we are we are well positioned to continue to drive the uptake of Zosturi. In terms of DTC and timing, you know, we have to go through all the development, and our marketing team is working on that now. In terms of launching it, it is it is more likely gonna be around the mid part of next year before, we are in market with the with the DTC. Campaign.

Elizabeth A. Barrett: And, David, maybe, would you wanna Sure. You know, when you think about I will be honest with the most compelling thing is actually the results that they see from a clinical perspective. And but we have always talked about the fact that the operational lift and the reimbursement lift are the biggest barriers, you know, to use. And you know, at the end of the day, our team is there to. And, you know, Christopher talked about all the. Which is the reason we have all these different roles is to help them operationally. So making sure that they are set up just to get it from the specialty pharmacy or the specialty distributor. In the case of the community practices, they want it mixed. So we mix it for them. So really getting it set up in the office is about training, making sure that the doctors are. You know, it is communicated to the practice. That they have gone through the administration. there is just a lot of, again, different people within an account that you have gotta get ready. So the operational pieces are-- I would say, are not necessarily a barrier. They take time 1 barrier has really come down to reimbursement, and changing a physician's mind that they do not need to do surgery. So those are the 2 biggest things we continue to hear even though we have great reimbursement, there is this kind of, quote unquote, fear of reimbursement and ensuring that they know that they are going to get reimbursed. And that is why they use it on a couple of patients first and make sure that they get reimbursed, and they get reimbursed at the level that they need to get reimbursed at before they are willing to adopt it broader into the office. So, again, the clinical message, what they are seeing when they actually use it, is driving them to use it again because they are seeing that it works. And they are seeing that they get reimbursed. So we just have to continue to knock down those barriers. So I hope that helps. Unfortunately, there is not like 1 thing that we can do that overcomes that. You have just got to be in that office, and, you know, every office is different. And so you gotta be in there, just talking to all of the different stakeholders within the practice. Very helpful. Thanks for taking our questionss.

Kevin DeGeeter: Thanks. Thank you.

Operator: I would now like to turn the conference back to Liz Barrett for closing remarks. Madam? Thank you.

Elizabeth A. Barrett: Yes, and thanks, everybody, for the great questions. I know-- look, we are, you know, every quarter, I know everybody wants us to tell what is exactly going to happen. What I can tell you is that the excitement that we see and hear when we talk to physicians about the role, whether I am out there, Mark's out there, We are out there all the time talking to docs, and they are continue to be very excited and continue to talk to us about how they are going to adopt it in their practice. So that gives us, along with the Q3 results, a lot of confidence that we will continue to grow and that we will continue to see our path to the $1.2 billion peak that we have talked about in the past. Also excited about all of the progress that we are making on our pipeline advancing 103 in life cycle management into other spaces, and really starting to get data on UGN-501. So it is an exciting time for our company, and Christopher talked about the fact that not only are we in a very good position from a cash perspective but expect to hit profitability in Q4. So it is an exciting year for us, and we expect to continue to drive adoption of Zosturi. Also, with Jelmyto, and to advance our pipeline. So we are, you know, really appreciate all the support as we build this long term sustainable growth company and we will keep you posted on all the updates. So that ends our call. Thanks, and you can disconnect now, operator.

Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.