URGN Q3 2026 earnings call transcript, November 4, 2026

We'll be right back.

Thank you for standing by, and welcome to URGN Pharma's third quarter, 2026 earnings conference call. Currently, all participants are in 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. To remove yourself from the queue, you may press star 11 again. I would now like to hand the call over to Vincent Perron, Senior Director of Investor Relations. Please go ahead.

Thank you. Good morning, everyone, and welcome to URGN Pharma's third quarter, 2026 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 30th, 2026. The release can be accessed on the investors portion of our website at investors.urigen.com. Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical 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 Zesturia and Gelmito, our ongoing and planned clinical trials and non-clinical 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 Zesturia's growth for URGN'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... 126 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 URGN disclaims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Director of URGN.

Good morning, and thank you for joining us today. We delivered another quarter of strong execution, with the STURI 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 Thank you for joining us today.

This momentum reflects the STURI's differentiated value proposition. As the first and only FDA-approved medicine for adults with recurrent low-grade, intermediate-risk, non-muslim-based bladder cancer, STURI offers a primary Thank you for joining us today. 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 September 30th, 2026, we had over 1,500 activated accounts. With a substantial foundation of activated accounts now in place, a 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 Thank you very much. in the second quarter, while repeat prescribers increased to 331 compared to 204 at the end of the prior period. Repeat prescribers now represent 50% of total riders, up from 45% in the second quarter and 40% in Q1. We continue to view repeat utilization as one of the strongest indicators of sustained adoption. As physicians gain experience with Sysdouris clinical

process. 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've 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 more. 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 first-hand experience using Zesturi. We expect these investments to support broader adoption and help realize the significant commercial opportunity ahead. During the third quarter, we did observe some anticipated 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.

Looking ahead to the fourth quarter, remain mindful of typical holiday-related slowdown, but continue to see opportunities to expand adoption and utilization and expect quarter-over-quarter revenue growth. Turning to Jalmito, net product revenue was $21 million in the third quarter, compared with $22 million in the second quarter. Importantly, this included a one-time unfavorable gross. the net adjustment of approximately $1.5 million, related to the CMS discarded drug provision TRU-UP. We are also seeing increased competition for eligible patients from ongoing clinical trials in the low-grade UTUC space, including our own UGM-104 Phase III trial, which has created some headwinds for patient starts. Nevertheless, Jalmito remains an important surgery-free treatment. An 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 UGM-103, our next-generation investigational therapy for adults with recurrent low-grade intermediate-risk non-muscle-basic 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. Review UGM-103 is a central component to our longer-term strategy. It is designed to build on the clinical and commercial foundation of Sesturi while offering potential manufacturing and operational efficiencies that can further strengthen our business over time and opportunities to expand into other non-muscle-based...

of bladder cancer populations. Importantly, our newly issued patent, now listed in the FDA's orange book, is expected to provide patent coverage into July of 2044 for both Sesturi and, if approved, UGN 103 for the treatment of low-grade, intermediate-risk non-muscle-based bladder cancer without a TURBT. We believe this further strengthens the long-term revenue potential for both... Beyond the initial indication, our planned expansion into high-grade NMIBC with UGN 103 represents an additional opportunity to broaden our reach and address unmet needs in uro-oncology. As part of our lifecycle management strategy for UGN 103, we also plan to initiate a non-registrational 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 three new oncology products using this technology, while also securing an exclusive option to acquire worldwide rights to their Sysplatin gel-based phase 2 ready therapy for advanced head and neck cancer. Importantly, this collaboration expands our capability beyond uro-oncology, while remaining aligned with our core expertise in 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've made through the first nine months of 2026 has strengthened our confidence in the opportunity ahead. The story 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 growth through commercial execution, lifecycle 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. 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'll turn the call over to Mark for a clinical update. Mark.

Thank you, Liz, and good morning, everyone. I'd like to begin by building on Liz's discussion on how Zesturi adoption is evolving, particularly as physicians gain experience and increasingly to incorporate the product into routine clinical practice. From a clinical perspective, what makes Zesturi 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. Zesturi, by contrast, offers a primary surgery-free approach with a defined six-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.

One of the more encouraging trends we're 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 this story 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 Zesturi is becoming more firmly integrated into the management of recurrent low-grade intermediate risk, NMIBC. Turning briefly to John Mito, we recently announced the publication of final five-year follow-up results from URGN Phase III Olympus trial in therapeutic advances in urology, further reinforcing the long-term durability of response with gel mito 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 to high-grade disease was observed. These findings further reinforced the clinical value of gel mito 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 14th, 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 III Utopia trial, which are generally consistent with the three-month complete response and six-month duration of response observed with Zesturi in the Pivotal and Vision trial. From a clinical perspective, the consistency of these results is highly encouraging and supports our confidence in the potential of UGN-103 to preserve the durable treatment profile established with Zesturi. We plan to supplement the submission with updated 12-month duration of response data as they become available and we'll 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 1st quarterly submission deadline, which would position us for a January 1st, 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 III trial in the fourth quarter, evaluating UGN 103 as adjuvant therapy in patients with recurrent, papillary-only, high-risk, non-muscle-invasive bladder cancer who have previously received BCG therapy. The study will compare...

URVT 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 lifecycle management strategy for UGN 103, we also plan to initiate a non-registrational 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 investigational mitomycin formulation for low-grade UTUC, the Phase III trial continues to progress, and we expect to complete enrollment. by the end of the year or in early 2027. Additionally, UGN 501, our investigational next-generation oncolytic virus for high-grade NMIBC, received FDA clearance of our IND in July, enabling us to initiate our Phase I clinical trial. The first patient has now been dosed, and we anticipate initial clinical data in 2027. Our Phase I study will evaluate intrabesicle 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 pretreatment requirements, such as a detergent wash, dosing

in a community. rules, or dose levels can be optimized. These potential benefits will require further evaluation as development progresses. EGN501 represents an important opportunity to expand our therapeutic capabilities beyond chemotherapy, initially within urothelial oncology and potentially into other solid tumors. Finally, I'd like to briefly expand on the strategic collaboration with Intragel that Liz referenced. RRGN501. RTGEL technology has demonstrated the ability 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 SRGEL platform offers a complementary approach. It is a biodegradable, sustained release platform designed to maintain high concentration. 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 and broadens our innovation capabilities beyond RTGEL. The first clinical application of that platform is a cisplatinum gel-based intratumoral injection, a Phase II-ready investigational therapy for advanced head and neck cancer. Early Phase I B data presented at ASCO demonstrated encouraging tolerability, low systemic cisplatinum exposure, and preliminary evidence of anti-tumor activity, including in patients with cisplatinum-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'll turn the call over to Chris to review our financial results. Chris?

Thank you, Mark, and good morning, everyone. Total revenue was $89 million in the third quarter of 2026, compared with $27.5 million in the third quarter of 2025. This increase was driven by the continued commercial launch of the story. 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 ongoings of story launch. We recorded a non-cash 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 2025. 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 2026 in connection with the Pharmacon refinancing, offset by the lower interest rate. Net loss in the third quarter was $1.5 million, or $3 million.

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 2025. As of September 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 one-time $4.8 million PDUFA fee associated with the UGN 103. NDA submission and a $4 million investment into InterGEL related to our strategic collaboration. With our current cash, cash equivalents, and marketable securities, together with $117 million in accounts receivable as of September 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 2026. Turning to guidance, we're updating our full-year Jalmito net product revenue guidance to approximately $90 million. This primarily reflects the $1.5 million unfavorable one-time gross-to-net adjustment Liz mentioned, together with headwinds from ongoing competitive clinical trial enrollment and low-grade upper-track urophilia. cancer that has affected Jalmito patient starts. As we have noted previously, we are not issuing full years of story 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 to $24 million of non-cash share-based compensation. We now anticipate operating expenses to land toward the upper end of the guidance range.

This guidance reflects our investment in historic healthcare professional education and patient awareness, startup activities for the UGN-103 high-grade trial, and development activities to explore UGN-501 with our RTGL technology. That concludes our prepared remarks. We will now open the call to questions.

Thank you. As a reminder to ask a question, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again. Please stand by while we compile the Q&A roster.

Our first question comes from the line of Leland Gershaw of Oppenheim. Your line is open, Leland.

other folks who have risk- thể-meditated, they're not necessarily the CDC. So any of those couldn't we do this? WESIANKS. 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 an earlier lines of therapy for this population. Liz and Chris may also want to have comments based on their understanding of the commercial launch? Sounds like that's the answer. Okay, thank you, and also, just curious, you know, given that... WBQ could have seen some seasonal weakness or softness in terms of visits and procedures. Just wondering if there's any way to either quantify or give color around, you know, how much that could have impacted Zesteroid, despite, obviously, the continued growth. Thank you. This is correct. So, just on the...it's 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 summer 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's really hard to quantify, you know, the true impact there. But, you know, as we said, we saw a bit of it there.

Yeah. Hi, it's Liz. And I apologize because I'm not in the room with the team. And so, I want to go back, Leland, to your previous question, though, when Mark answered, I couldn't get off the mute fast enough. But I'll answer that question first. I don't 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, you know, new patient starts are fairly... variable anyway, I don't think we lost a lot of patients, if that makes sense. So, while we did see, you know, a leveling of pests, you know, for a couple of weeks, it came right back. And because it takes several weeks anyway for these patients, I would say that it didn't have a huge impact on revenue. So, you know, maybe minimal, but not huge. Going back to... Mark, though, I want to be really clear. We actually are seeing, in the claims database, we're seeing usage across the board. So not just...I think what we've 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've seen that in the claims database, where we've seen this shift to physicians. Using it after one and after two. And so it's a pretty even group of patients, like I said, after one, after two. Yeah, you see the ones after three, after four, after five. We've got patients, as we've talked about before, after 20 and after 40 TRVTs. So it is across the board, but any physician is going to likely start with their more heavily pretreated patient, but adopt it across the board.

We're still seeing that, and that's what we're hearing also from physicians as we're out there, you know, talking to physicians. So I hope that helps, and my apologies for being delayed. Yeah, absolutely. Thank you very much. Very helpful.

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

Yeah, so Tara, this is Chris. I'll start, and then Liz, you can jump in. Just in terms of the Q3 dynamics, I think just Delmetto is not a great analog here, Tara, just mainly one, just the sheer number of patients, right, in terms of the story market opportunities much larger. And so coming into the quarter, you know, we anticipated some seasonalities we talked about, but, you know, we're confident that just given the number of available patients that, you know, would more than offset, you know, any potential seasonal impact, which we saw. So I think this is part of it as we think about the story guidance, wanting to get through some of these quarterly dynamics just to better understand kind of the magnitude and what this looks like. So hard to predict, you know, exactly what this would look like on a recurring basis, but... Still, in the early stage of launch, think that there's obviously opportunity for continued quarter-over-quarter growth momentum here. So coming on to your point then around Q4, you know, we do continue to expect to see, you know, quarter-over-quarter revenue. We're encouraged by the trends we're seeing in terms of the number of new prescribers within Q3, as well as the percentage of those prescribers who become repeat writers. So, you know, we are mindful, as Liz mentioned in remarks, that, you know, 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 Sistory 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 Sistory.

Okay, sounds great. Thanks.

Thank you. Our next question comes from the line of Raghuram Sovaraju of H.C. Wainwright Company. Your line is open. Raghuram.

Hey, Chris, I'll take that. Hi, Ram, it's Liz. I think what we're doing, and I think it's fair to say that Jalmaido, like every other product that I've ever been familiar with, is promotion sensitive. And so what we're doing... is we are developing sort of a strike team to go into sort of our heavy users of Jalmaido to ensure that we maintain that 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'm very surprised that you've got about four or five companies right now doing studies. And, 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 annualized, you know, if you annualize it, it's 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 going to be, yeah, once we get past this hump, granted, there's still going to be clinical. Trials in 2027. So you'll still continue to have that headwind there. But I do think that there's opportunity to get back on track with JAMAIDO in the sense of our trial will be fully enrolled. Our UGM 104 trial. So that's one that will be done. And as they start to end, I think you'll see that. And then I do think that adding some promotional muscle back behind. Jalmito specifically. And look, we prioritize the story. We made that decision. And, you know, we knew that there was a potential that, you know, that Jalmito 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 one and a half million dollar hit from there. So we've had a few headwinds there, but still think that there's a lot of opportunity on Jalmito.

But what we've said, you know, it's likely to be around a hundred million dollar 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've always talked about the fact that we felt like, you know, within that one to one fifty range is likely to be where Jalmito will be long term. And then with respect to this, this very franchise just. Two 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 twenty twenty seven. Also, if you could maybe comment on the trend with respect to percentage. of repeat prescribers as a percentage of a total of the total prescribers going forward. And if you anticipate that there might be the likelihood of that percentage ticking up meaningfully above the fifty percent level. And with respect to the one or three application, if there has been any indication from the reviewers of that application that they want to see additional controlled data or if really what they are looking for. It's 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.

Chris, you want to start? Yeah, so let's all start with the activated sites and a little bit around the prescriber rate and then maybe turn it over to the market. Mark on the 103 question and then to you for the intragel piece. So just, Ram, on activated sites, you know, we've done a good job of, you know, building a substantial foundation there in terms of activated sites, and we'll continue to add them, and it can be a bit lumpy, as you've 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, dropped. And so, you know, I think really the focus has been, and 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's substantial opportunity here to expand adoption within the existing account base that we've already set up. But we will continue to add, you know, accounts as we go. In terms of the repeat prescriber rate, again, that's a rate that, you know, we look at because, as Mark mentioned, you know, typically what urologists are doing is trying Zestory on one or two patients, understanding kind of the reimbursement dynamics, how it incorporates in their operational workflow, looking at the clinical experience, and then, you know, starting to use it 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're really pleased with how that's tracking in terms of performance in Q3, but then also, you know, expanding that repeat writer base. And so we would expect the number of repeat writers as they get experience with the story to continue to grow as well. Ron, thanks for the question about 103. We've 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 hasn't been any change in that to date. Yeah, and look, I'm just going to comment a little bit more around your question around can it accelerate and can you have an inflection point? I don't think you'll see an inflection point in the next few quarters, right? I think there's two things, and we've talked about this a little bit before, that could cause an inflection. One, we've talked about DTC. We are going all in on DTC in 2027. That takes time, so it's not likely to be, you know, before kind of mid-year 2027, and I do think that that can be a real driver and inflection point for us, and the other is, to your point, you've got to get a lot of large group practices and these community practices where the most patients are to really implement

kind of a bladder line of service. What do I mean by that? They talk a lot about patient navigators having these bladder champions where they go and they're actually actively looking for patients. I think when you do get to enough of a breadth of those types of practices, then you can see kind of an inflection point. We think about bladder cancer every day. But urology practices is only about 20% of their practice, right? So they've got a lot of other things on their mind. So these types of things take time. But 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 hearing, we continue to hear very positive feedback. About their intention to use the story and their intention to continue to drive that depth of usage in their practice. And today, yeah, I mean, we talk about, we've grown our number of users. But the reality of it is, is that that's still a very small percentage of the total urologist. So what is driving our revenue today is the depth of those users. So that's why, you know, we have to get the breath. And the depth in those. So, so like I said, what's driving more today is more of that depth. And yes, we do expect that more and more will more than 50% will, that will continue to grow as we, you know, they're a quote unquote repeat users. We, we don't see any kind of one and one and done. And, and, you know, we've talked about our, all of our research, 100% of physicians who have used it said they'd use it again. And so, and we know that patients.

Are really happy with it. So when those all things come together, you know, we'll continue to, we expect to continue to see growth. On the intragel, basically we need to see positive data in their phase two study. And, and that's, that's when we would discuss whether it makes sense for us to, to, to take that forward. So that, that's really what we would be looking at for the intragel. It's a, it's a, it's a similar approach. And so one that we're quite familiar with. We're, you know, we, you know, we like the data we've 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, Ron. Yes. Thank you very much.

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

Every day in terms of getting our sales force out there, 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 getting them out there, getting them comfortable with the reimbursement profile and the operational dynamics of this is obviously a key part of our strategy. Thank you. And just one quick follow-up. What is this? Is the story being used as a primary therapy versus an adjuvant? Yeah, so it's Liz. Right now, and this is just anecdotal and through our claims database. So it's, you know, just take it for what it's worth, right? We don't have quantitative and we don't capture that information. But 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 TRBT first and then come back with it. And we're seeing more and more doctors being more comfortable with primary treatment, which is what we think is what we should do. And that's what we talk about. And that's what we promote. And so we think that's in the best interest of the patient. So you're seeing now the amount of adjuvant decline to a little bit less than 40%. Great. Thank you so much.

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

Mark? You know, with respect to the durability data, we obviously think that the 12-month durability data will be incredibly important to the label as it was with SysDuri. So it's an important update, but it won't change the timeline of review. And then... Chris. So just in terms of the transition, so the plan, you know, is, you know, right now with the 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 January 1st, 2028. And then, you know, at some point during, you know, 28, you know, we do have, you know, flexibility here in terms of just given, you know, the additional IP that we... have for Zesturi 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, 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 28 for both products to be on the market. And then, you know, one point where we have... As the majority of patients moved over, we will pull this story from the market. Great. Thank you.

Thank you. Our next question comes from the line of Amin Makarum of Jefferies. Your line is open, Amin.

I mean, I'll start with the linear, you know, growth question. And so, you know, we've said, you know, even coming into the start of the year that we, you know, 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... I know you mentioned the $20 million, which was the growth rate for absolute growth between Q2 and Q1. If you think about Q1, that grew about $15 million, and this past quarter grew about $18 million. And so we've said, like, look, we do expect a linear, a general linear growth trajectory, but that there's going to be some quarter-to-quarter variability. And so I think, you know, thinking about it in the framework of, you know, we've been growing $15 to $20 million this year. And, you know, we said, you know, as we think about Q4, we expect continued growth, and we're comfortable with where full-year consensus currently sits for Zestory. So you're trying to factor in those quarterly dynamics at play. I think, you know, when we think about the trajectory in the 27, we're not issuing guides at this point for Zestory and haven't really provided much in terms of context for 27 Outlook. But if 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 103 program, maybe I'll turn it over to Mark just to think about how we're looking at that.

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 Zestory as an adjuvant and presumably would also use 103 as an adjuvant in some select patients with safety and tolerability information. Remember, we primarily study patients using Zestory 102 and 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 advocacy information as well as part of that trial. This is, as you noted, it's not a registrational trial, so we would not be. Planning on changing the label based on these data, but I would defer to Liz as to whether or not she thinks this would impact guidelines. Yeah, I think that there's definitely will be enough information and enough data when you combine it with our ATLAS study. You know, whether we'll get in the guidelines or not, you know, I don't know. You know, I can't really comment on that. That's not really our goal, Mark said. You know, the object of it, you know, the really objective is to ensure that you don't have to understand it. Physicians understand the data because we haven't generated data in that specific patient population. I think it's 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 there's data generated in that space. And that's the goal. And look, if it's 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's some data.

generated in that patient population, which is really the only patient population in the low-grade IR space that we haven't studied. But we would absolutely submit the data, both the results of this study along with our ATLAS data, and have published data around that so that physicians would have access to that.

Thank you. Our next question comes from the line of Kevin DeKeter of Leidenberg-Thalman. Your line is open, Kevin.

Hey, Liz, I'll start with the headcount expansion and timing on DTC, and then you can comment around, you know, 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 Sudari. 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 Sudari, 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're well positioned to continue to drive the uptake of Sudari. In terms of... With the 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's more likely going to be around the mid-part of next year before we're in market with the DTC campaign.

Sure. You know, when you think about...I'll be honest with you, the most compelling thing is actually the results that they see from a clinical perspective. But we've always talked about the fact that... that the operational list and the reimbursement list are the biggest barriers to use. And, you know, at the end of the day, our team is there to...and, you know, Chris talked about all that, and which is the reason we have all these different roles, is to help them operationally. So making sure that they're set up just to get it from the specialty pharmacy or the specialty distributor. In the case of a... of the community practices, they want it mixed. So we mix it for them. So when really getting it set up in the office is about training, making sure that they, the doctors are, you know, it's communicated to the practice, that they've gone through the administration. There's just a lot of, again, different people within an account that you've got to get ready. So the operational pieces are, I would say, aren't necessarily a... They take time. When a barrier has really come down to reimbursement and changing a physician's mind that they don't need to do surgery. So those are the two biggest things. We continue to hear, even though we have great reimbursement, there's just this kind of, quote-unquote, fear of reimbursement and ensuring that they know that they're going to get reimbursed. And that's 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're willing to adopt it broader into the office. So again, the clinical message, what they're seeing when they actually use it, is driving them to use it again, because they're seeing that it works, and they're seeing that they get reimbursed. So we just have to continue to knock down those barriers. So hope that helps. Unfortunately, there's not like one thing that we can do that overcomes that. You just got to be in that office, and every office is different. And so you've got to be in there just talking to all of the different stakeholders within the practice. Very helpful. Thanks for taking our questions. Thanks. Thank you. I would now like to turn the conference back to Liz Barrett for closing remarks. Madam? Thank you. Yeah, and thanks everybody for the great questions. I know, look, every quarter I know everybody wants us to tell what's exactly going to happen. What I can tell you is that the extent. Excitement that we see and hear when we talk to physicians about the role, whether I'm out there, Mark's out there, we're out there all the time talking to docs, and they continue to be very excited and continue to talk to us about how they're going to adopt it in their practice. So that gives us, along with the Q3 results, a lot of confidence that we'll continue to grow this story, and that we'll continue to see our path to the $1.2 billion peak that we've talked about in the past. Also excited about all of the progress that we're making in our pipeline, advancing 103 and lifecycle management into other spaces, and really starting to get data on UGN 501. So it's an exciting time for our company, and Chris talked about the fact that not only do we are in a very good position from a cash perspective, but expect to hit profitability.

And Q4. So it's an exciting year for us, and we expect to continue to drive adoption of the story, also with Jalmito, and to advance our pipeline. So we really appreciate all the support as we build this long-term sustainable growth company, and we'll keep you posted on all the updates. So that ends our call. Thanks, and you can disconnect now, operator.

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