UroGen Pharma Ltd. (URGN) Earnings Call Transcript & Summary

Thank you for standing by, and welcome to UroGen Pharma's Third Quarter 2026 Earnings Conference Call. [Operator Instructions] I would now like to hand the call over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

Thank you. Good morning, everyone, and welcome to UroGen 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 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; 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 ZUSDURI 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 ZUSDURI'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'll now turn the call over to Liz Barrett, Chief Executive Officer. Liz?

Good morning, and thank you for joining us today. We delivered another quarter of strong execution with ZUSDURI 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 ZUSDURI is scaling successfully and establishing a strong foundation for sustained growth. This momentum reflects ZUSDURI'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, ZUSDURI 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 September 30, 2026, we had over 1,500 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 331 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 one of the strongest indicators of sustained adoption. As physicians gain experience with ZUSDURI'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 the 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 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 ZUSDURI. 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 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 of demand. Looking ahead to the fourth quarter, we 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 JELMYTO. Net product revenue was $21 million in the third quarter compared with $22 million in the second quarter. Importantly, this included a onetime unfavorable gross to net adjustment of approximately $1.5 million related to the CMS discarded drug provision true-up. We are also seeing increased competition for eligible patients from ongoing clinical trials in the low-grade UTUC space, including our own UGN-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. Review UGN-103 is a central component to our longer-term strategy. It is designed to build on the clinical and commercial foundation of ZUSDURI 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 of 2044 for both ZUSDURI 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 UGN-103 represents an additional opportunity to broaden our reach and address unmet needs in neuro-oncology. As part of our life cycle 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 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 uro-oncology while remaining aligned with our core expertise and localized sustained drug delivery. We believe it creates meaningful opportunity to broaden our pipeline, advance innovation across additional solid tumors and support future growth. In closing, the progress we made through the first 9 months of 2026 has strengthened our confidence in the opportunity ahead. ZUSDURI 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, 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 neuro-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 ZUSDURI adoption is evolving, particularly as physicians gain experience and increasingly incorporate the product into routine clinical practice. From a clinical perspective, what makes ZUSDURI 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. ZUSDURI, 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. 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 ZUSDURI 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 ZUSDURI 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 3 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 to 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 ZUSDURI in the pivotal ENVISION 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 ZUSDURI. 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 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 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 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 RTGel 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 non-registrational trial evaluating 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 3 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 1 clinical trial. The 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 RTGel 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 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 and potentially into other solid tumors. Finally, I'd like to briefly expand on the strategic collaboration with IntraGel that Liz referenced. Our 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 avoided. IntraGel's SRGel 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 and broadens our innovation capabilities beyond RTGel. The first clinical application of that platform is the 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 of 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'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 ZUSDURI. 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 ZUSDURI 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 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 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 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 onetime $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 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 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 ZUSDURI 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 ZUSDURI health care 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 Instructions] Our first question comes from the line of Leland Gershell of Oppenheimer.

Just 2 from us. First, I just want to drill in a bit, Mark, on your comments about sort of the type of patients who would be the go-to for ZUSDURI versus another TURBT. It sounds like given the data, ZUSDURI 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 have a follow-up.

Sure. So thank you, Leland. What we're seeing urologists do right now is, as Liz mentioned, and as has been said on multiple calls before, this one is get familiar with the drug. The data support using this in patients with a recurrence or maybe 2 recurrences. In fact, that's what we study. 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 recurred after standard of care, which would be TURBT. And then based on guidelines, possible use of intravesical postoperative therapy. So anybody who's recurred with low-grade disease could receive the drug. But again, what we're seeing is the doctors are getting familiar. So they're using it in patients who have 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 Chris may also want to have comments based on their understanding of the commercial launch.

Thanks, Leland. It sounds like that's the answer.

Okay. And also, just curious, given that 3Q 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 how much that could have impacted ZUSDURI despite, obviously, the continued growth.

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

Yes. 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 of 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 pests and 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 a leveling of pests for a couple of weeks, that 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 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 the shift to physicians using it after 1 and after 2. And so it's a pretty even group of patients, like I said, after 1 after 2, yes, you see the ones after 3, after 4, after 5, we've got patients, as we've talked about before, after 20 and after 40 TURBT. 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. And we're still seeing that, and that's what we're hearing also from physicians as we're out there talking to physicians. So I hope that helps, and my apologies for being delayed.

Our next question comes from the line of Tara Bancroft of TD Cowen.

Congrats on this great quarter. I know that it's challenging to predict going forward, but I'm 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 could 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?

Yes. Tara, this is Chris. I'll start and then Liz, you can jump in. Just in terms of the Q3 dynamics, and I think just JELMYTO is not a great analog here, Tara, just mainly, one, just the sheer number of patients, right, in terms of ZUSDURI's market opportunity is much larger. And so coming into the quarter, we anticipated some seasonality as we talked about, but we're confident that just given the number of available patients that would more than offset any potential seasonal impact, which we saw. So I think this is part of it -- as we think about ZUSDURI guidance, wanted to get through some of these quarterly dynamics just to better understand kind of the magnitude of what this looks like. So hard to predict exactly what this will look like on a recurring basis, but still in the early stage of launch, I think that there's obviously opportunity for continued quarter-over-quarter growth momentum here. So coming on to your point then around Q4, we do continue to expect to see 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 we are mindful, as Liz mentioned in her remarks, that there could be some typical holiday-related seasonality in Q4. We have -- we did see it a bit even in the early stage with ZUSDURI launch last year where the weeks of the holidays, you can have fewer patient starts and doses shipped. But overall, we do expect continued growth, and we are comfortable with where consensus sits for the full year for ZUSDURI.

Our next question comes from the line of Raghuram Selvaraju of H.C. Wainwright Company.

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're seeing any indications of market saturation?

Chris, I'll take that. Ram, it's Liz. I think what we're doing, and I think it's fair to say that JELMYTO, 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 JELMYTO to ensure that we maintain that promotional the promotional share of voice in there. Having said that, we really did get hit with the clinical trials. And I have to be honest with you, I'm very surprised that you've got about 4 or 5 companies right now doing studies in 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 -- if you annualize 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, yes, once we get past this pump, 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 JELMYTO in the sense of our trial will be fully enrolled. Our UGN-104 trial. So as we -- 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 JELMYTO specifically. And look, we prioritized the story. We made that decision. And we knew that there was a potential that JELMYTO would have challenges. I think our hope is that with the incremental physicians, you would see some of that come back. But -- and as we talked about with the $1.5 million hit from there. So we've had a few headwinds there, but still think that there's a lot of opportunity on JELMYTO. But what we've said, it's likely to be around $100 million opportunity. As we get into UGN-104, there may be some opportunity there that could draw that a little bit higher than that. But we've always talked about the fact that we felt like within that 100 to 150 range is likely to be where JELMYTO will be long term.

And then with respect to the ZUSDURI 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 2027. Also, if you could maybe comment on the trend with respect to percentage of repeat prescribers as a percentage of 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 want to 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.

Chris, do you want to start?

Yes. So Liz, I'll 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, we've done a good job of 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 has really been focused on driving and converting those accounts into prescribers. And so 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 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 accounts as we go. In terms of the repeat prescriber rate, again, that's a rate that we look at because as Mark mentioned, typically, what urologists are doing is trying just on 1 or 2 patients understanding kind of the reimbursement dynamics, how it incorporates in their operational workflow, looking at the clinical experience and then starting to use them on additional patients. And so 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 expanding that repeat writer base. And so we would expect the number of repeat writers as they get experienced with ZUSDURI to continue to grow as well.

Ram, 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 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.