UroGen Pharma Ltd. Q1 FY2025 Earnings Call

Hello and welcome to UroGen Pharma's First Quarter 2025 Earnings Conference Call. All participants are currently in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to turn the conference over to Vincent Perrone. You may begin.

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's first quarter 2025 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31st, 2025. The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing pre-commercialization activities related to UGN-102, regulatory meetings and decisions, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN-102 if approved, market and revenue opportunities, commercialization activities related to JELMYTO, our ongoing and planned clinical trials, commercial and clinical milestones, UGN-102 being the primary growth driver for UroGen, future R&D efforts and our goals and 2025 financial guidance, among other things. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Officer. Liz?

Thank you, Vincent, and thank you all for joining us this morning. The new drug application for our lead development stage candidate, UGN-102, is now in the final stages of FDA review with a PDUFA target date of June 13th. We designed UGN-102 as a novel and innovative treatment for patients with low-grade intermediate risk non-muscle invasive bladder cancer. We believe UGN-102 has the potential to change the treatment paradigm and meaningfully improve the standard of care in this patient population. If approved, UGN-102 will be the primary growth driver for our company and alongside JELMYTO, could solidify our leadership in the urothelial cancer space, advancing our mission to bring innovative patient-centered solutions to urologic cancers. We have been informed by the FDA that an Oncologic Drugs Advisory Committee or ODAC meeting has been scheduled for UGN-102 on May 21st. This is consistent with our expectations, and we look forward to the opportunity to showcase the strength and consistency of our clinical data to the members of the panel and the public. We have been preparing for the ODAC meeting and believe we are well prepared to present a clear, compelling, and scientifically robust case supporting the approval of UGN-102. In parallel, our regulatory team continues to engage regularly with the agency and has been responding to their information requests. To date, we've encountered no resource or policy-related issues that concern us. The UGN-102 NDA is supported by a robust development program demonstrating meaningful complete response rates, durable responses, and an acceptable safety profile across three late-stage clinical trials. In March, we reported updated data from the pivotal ENVISION trial, demonstrating that 80.6% of patients who achieved a complete response at three months remained in response at 18 months per Kaplan-Meier estimate. It's important to highlight that these robust results are with UGN-102 alone and not following a transurethral resection of bladder tumor. Additionally, there are six weekly installations, and then patients are treatment-free until recurrence. As Mark will highlight, these results, along with a broader update on UGN-102 and JELMYTO, were shared with the urology community at this year's AUA meeting, underscoring our clinical leadership and commitment to advancing innovation in uro-oncology. With the PDUFA date goal approximately one month away, our commercial team has been actively preparing for the potential launch of UGN-102. This launch would mark a pivotal moment in UroGen's evolution from a rare disease-focused company to a scaled multi-product team positioned to serve a significantly broader patient population. We're expanding our commercial footprint accordingly with plans to grow our sales force from approximately 50 reps today to over 80 at launch. Our medical affairs and market access teams are also deeply engaged in pre-launch planning. We are targeting commercial readiness by June and we will be ready to promote immediately following approval with product availability in July. UGN-102 represents a transformative growth opportunity for UroGen. We estimate an addressable population of approximately 60,000 patients annually with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, translating to a market opportunity of over $5 billion. This is nearly 10 times larger than the JELMYTO market. Critically, this market is highly accessible. Unlike the more fragmented UTUC setting, NMIBC patients are widely distributed and primarily managed by community urologists across the country. UGN-102 is well aligned with current clinical workflows. It's easy to administer, does not require specialized equipment, and can be delivered by a nurse with minimal additional training. We believe these advantages position UGN-102 to become a foundational therapy in the management of low-grade intermediate-risk non-muscle invasive bladder cancer and a significant driver of long-term value creation for UroGen. Turning to JELMYTO, we reported $20.3 million in first quarter sales, an 8% year-over-year growth compared to the first quarter of 2024, driven by underlying demand growth of 12%. We continue to advance our pipeline across multiple fronts, including our next-generation programs for JELMYTO and UGN-102, as well as our emerging immuno-oncology initiatives. In February, we acquired product candidate ICVB-1042, a next-generation investigational oncolytic virus from IconOVir, which we have assigned an internal code name of UGN-501. This is an important step in expanding our presence in immune-based therapies for urologic cancers. In parallel, we also have multiple strategic research collaborations in place, aimed at leveraging our proprietary RTGel technology to enhance the delivery and effectiveness of various existing drugs. UroGen is executing with focus and discipline. We remain committed to transforming the treatment landscape in uro-oncology and are supported by a strong balance sheet with just over $200 million in cash, cash equivalents, and marketable securities as of March 31st. We are investing in innovation with purpose, driven by the opportunity to make a meaningful impact on patients while delivering value to our shareholders. I will turn the call over to Mark Schoenberg, who will provide a clinical update. Mark?

Thank you, Liz. I would like to echo what Liz shared regarding the strength of the clinical data supporting UGN-102. We've assembled a compelling and comprehensive clinical package that we believe demonstrates both the safety and efficacy of UGN-102. This gives us a high level of confidence as we approach the upcoming ODAC meeting and the PDUFA target date. This year's AUA was an important event for UroGen. It provided a valuable platform to present the latest data on UGN-102 and JELMYTO with the broader urologic community. We were proud of the six abstracts accepted, reflecting the growing body of evidence behind our programs and the continued momentum of our clinical efforts. The highlight was the updated 18-month duration of response data from the Phase 3 ENVISION trial, which, as you know, is the pivotal trial that is the foundation of our NDA for UGN-102. The data were featured in a podium presentation by Dr. Sandip Prasad, the principal investigator on the study. We are highly encouraged by the continued durability of response observed in the Phase 3 ENVISION trial. Among patients who achieved a complete response, the duration of response to 18 months remains strong at 80.6% by Kaplan-Meier estimate. Median follow-up time has now extended to 18.7 months post three months complete response, up from 13.8 months at the previous data cut, and the median duration of response has still not been reached. For reference, the 12-month duration of response was previously reported at 82.5%. These results continue to reinforce the potential of UGN-102 to offer a durable non-surgical treatment approach for patients with recurrent low-grade intermediate-risk NMIBC. We also presented a poster featuring patient-reported outcomes from the three late-stage UGN-102 studies, OPTIMA II, ATLAS, and ENVISION. These assessments use the EORTC 24-item quality of life questionnaire specific to NMIBC to evaluate the symptom burden and overall health status and function. The findings were consistent across trials, showing the treatment with UGN-102 did not negatively impact symptom burden, patient function, or quality of life, an important consideration for a novel therapy intended for use in routine clinical practice. At the AUA, we also shared data from the Phase 1 dose escalation study of UGN-301, our investigational anti-CTLA4 antibody delivered via RTGel. These results were previously presented at SUO in late 2024 and continue to support a favorable safety profile for UGN-301, both as monotherapy and in combination with UGN-201, our TLR7 agonist, and with gemcitabine. We observe clinical responses in both the monotherapy and combination arms, with follow-up on the combination arms ongoing to evaluate durability of response. We expect to share updated data from this program later this year. At that point, we anticipate being in a position to make a go/no-go decision on whether to advance UGN-301 into Phase 2 development. Our next-generation candidates are actively advancing through development. Enrollment is ongoing in the Phase 3 UTOPIA trial, which is evaluating UGN-103 in patients with recurrent low-grade intermediate-risk NMIBC. UTOPIA is a single-arm multicenter study modeled on the ENVISION trial. Efficacy will be measured by complete response at three months following treatment, with follow-up focused on assessing durability. Enrollment is progressing ahead of plan and we expect to complete enrollment by the middle of this year, with topline data anticipated in 2026. We are taking a similar approach with UGN-104, our next-generation formulation of JELMYTO, and expect to commence the single-arm Phase 3 study by midyear this year. Now over to David Lin for a commercial update.

Thank you, Mark. Our organization is now fully engaged in the final stages of pre-launch activities for UGN-102. The goal is to deliver a seamless and impactful launch that will ensure timely access for patients as soon as possible following approval. Our team is highly energized and we have the necessary experience, resources, and talent to drive adoption. Our clinical data supports our conviction that UGN-102 can be a transformative product that will change the standard of care in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. There are three ongoing activities that I want to highlight. First, our medical affairs team is leading an educational effort, engaging directly with urologists to highlight the unmet need in recurrent low-grade intermediate-risk NMIBC and ensure strong awareness of the clinical evidence supporting UGN-102. Second, we are scaling the organization to capture the larger opportunity in low-grade intermediate-risk non-muscle invasive bladder cancer. This includes expanding our sales force from approximately 50 reps today to over 80 at launch. We are also building out the rest of the commercial infrastructure, including a robust patient support and distribution network. Third, we are executing a focused payer engagement strategy. Our market access and medical affairs teams are actively engaging with payers and formulary decision makers to communicate the clinical data supporting UGN-102. We recognize that timely access can make a meaningful difference for patients, and our goal is to ensure coverage decisions are aligned closely with approval to support rapid adoption. If approved, UGN-102 will launch with a temporary miscellaneous J-code and we anticipate securing a permanent product-specific J-code by January 2026, which will be particularly important for broad adoption in the community setting. In the first six to nine months, our strategy is to focus on a defined group of urologists who have demonstrated a willingness to adopt new therapies during the miscellaneous J-code period. We are also working to identify affiliate sites of care for these physicians to help facilitate access and to support product administration. Our experience with JELMYTO, along with recent customer insights, tells us that many providers prefer to initiate use of new therapies in the hospital outpatient setting where pharmacy budgets are often managed as separate cost centers. During this initial phase, our goal is to establish a strong foundation for UGN-102 adoption, positioning us for broader expansion once the permanent J-code is in place. As we enter the final phase of pre-launch execution, we do so with confidence and momentum. The interest from the healthcare community in UGN-102 has been very encouraging and we are implementing a robust strategy to support its introduction. Now turning to JELMYTO. First quarter sales were $20.3 million with demand continuing to grow at a double-digit pace. We remain focused on high-frequency engagement with our top performing accounts. As we scale our commercial organization in preparation for the anticipated launch of UGN-102, our expanded sales force will also support continued promotion of JELMYTO. This integrated effort will allow us to deliver broader utilization across both products while maximizing the impact of our commercial infrastructure. I will now turn the call over to Chris Degnan to review our financial results.

Thank you, David. JELMYTO net product revenues were $20.3 million and $18.8 million for the three months ended March 31st, 2025, and 2024 respectively. Year-over-year revenue growth of 8% was driven by underlying demand growth of 12%, partially offset by higher 340B chargebacks. The gross-to-net rate for JELMYTO has stabilized in recent quarters and we expect resulting headwinds on year-over-year growth to be less impactful going forward. R&D expenses for the first quarter of 2025 were $19.9 million, including non-cash share-based compensation expense of $0.6 million as compared to $15.5 million, including non-cash share-based compensation expense of $0.5 million for the same period in 2024. The year-over-year increase in R&D expenses was primarily driven by the equity consideration issued to IconOVir for the acquisition of UGN-501, which was expensed in the quarter, higher manufacturing costs, and costs associated with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower clinical trial costs and regulatory expenses in connection with UGN-102. Selling, general, and administrative expenses for the first quarter of 2025 were $35 million, including non-cash share-based compensation expense of $2.5 million. This compares to $27.3 million, including non-cash share-based compensation expense of $2.2 million for the same period in 2024. The year-over-year increase was primarily a result of UGN-102 commercial preparation activities. We reported non-cash financing expense related to the prepaid forward obligation to RTW investments of $4.6 million in the first quarter of 2025 compared to $5.7 million in the same period in 2024. Interest expense related to the $125 million term-loan facility with funds managed by Pharmakon Advisors was $4.1 million in the first quarter of 2025 compared to $2.4 million in the same period in 2024. The increase was primarily driven by interest expense related to the $25 million third tranche of the loan that was funded in September 2024. Net loss was $43.8 million or $0.92 per basic and diluted share in the first quarter of 2025 compared with a net loss of $32.3 million or $0.87 per basic and diluted share in the same period in 2024. As of March 31st, 2025, cash, cash equivalents, and marketable securities totaled $200.4 million. Turning now to guidance. We last provided financial guidance with our year-end 2024 results in March, and that guidance remains unchanged. We continue to expect full-year 2025 net product revenues from JELMYTO to be in the range of $94 million to $98 million and this implies a year-over-year growth rate of approximately 8% to 12% over the $87.4 million in demand-driven JELMYTO sales in 2024, which excludes the $3 million in CREATES Act sales reported in 2024. Guidance on full-year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million, including non-cash share-based compensation expense of $11 million to $14 million. We're now ready to open the call for questions. Operator?

Thank you. Our first question comes from Tara Bancroft with TD Cowen. Your line is open.

Hi. Good morning and thanks for taking the questions. So I was hoping that in light of today's events, can you possibly give us the breakdown of Medicare and Medicaid exposure that you anticipate for UGN-102 and currently for JELMYTO? And really how you think pricing dynamics could play out? Thanks so much.

Yes. Hi, Tara. It's Liz, and I'll ask David to comment on that in a moment. When thinking about the percent of our business, keep in mind that we are only a US-focused company, so we don't have any issues from a best price perspective or favored nation perspective outside. So we don't have any risk associated with that. But David, can you just talk about the Medicare?

Yes. Hi, Tara. It's David. We anticipate that the Medicare population will comprise about 70% of our business, very consistent with the overall patient demographic in low-grade intermediate-risk NMIBC. And as we think about a launch, our principal priority will also be to drive reimbursement confidence with the providers who treat these patients. Thanks very much for the question. Appreciate it.

Please standby for our next question. Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is open.

Oh, hey, good morning. Thanks for taking my question. Congrats on getting one step closer to this exciting approval. In terms of preparing for the ODAC, I guess, how are you preparing and where do you expect the most pushback from the panel and what do you think are your strongest arguments there? Thank you.

Yes. Hi, Kelsey, it's Liz. Thanks for the question. We have been preparing for quite a few months, frankly since last fall. We have had our mock ODAC panels. We've had several now. We've had them with distinguished guests that have included our medical oncologists who have been on ODAC, as well as statisticians. So what we've tried to do is really have a situation where we are simulating an ODAC meeting. Many of the members have been ODAC members in the past, some have even been leaders of the ODAC. So we felt like we've really put ourselves through the paces, and we will continue to do so up until the day of the ODAC. I'm going to give my perspective and then I'm going to turn it over to Mark and ask him to comment as well. So my perspective is that the biggest question is centered around the fact that ENVISION is a single-arm study—it serves as the basis for our approval—and how the results compare and are put in context. In other words, it sounds great, right? Your 80% sounds great, but I don't have anything to compare it to. Unfortunately, with the exception of our own study ATLAS, there hasn't been a lot of peer-reviewed studies or data published in this specific patient population, the low-grade intermediate-risk non-muscle invasive bladder cancer. So it's really about putting it in context and how to take a single-arm study and put that data in context. Having said that, we obviously feel really good about it. And I can tell you that in our mock ODACs, we've gotten a positive vote, even under rigorous scrutiny. We give our presentations, present to the FDA, and provide them with a briefing book. So we've tried to simulate an ODAC meeting as closely as possible, and ultimately, we have come out with a positive vote. But Mark, can you comment on the second part of Kelsey's question regarding why we feel good about our position and what our arguments are?

Sure. Thanks, Liz. What we have, for starters—and this came out of extensive conversations with the FDA in preparation for this meeting—is the fact that, as everybody listening probably remembers, we're working in a recurrent population. So the patients we are treating and discussing in this meeting are those who have already had surgery and who have recurred. The agency identified this as the greatest unmet medical need, and we completely agree. These patients have failed the standard of care and then received primary treatment, as Liz pointed out, with UGN-102 and achieved an 80% complete response rate. Eighteen months later, the durability of that response is over 80%. From a clinical perspective, these are remarkable results. I think one of our strongest arguments is that we have great results in a population of patients who didn't do well with the standard of care. That's number one. In addition, our experience with the mock panels, as Liz indicated, has been favorable precisely because of the encouraging safety profile and the remarkable results of the ENVISION trial, alongside supportive data from ATLAS and OPTIMA. We believe that the conversations will center around how to interpret the single-arm trial, and we have scoured the literature as thoroughly as possible to gather all supporting data for the single-arm trial. We also emphasize the meaningfulness of ATLAS, the safety profile, the unmet medical need, and how to articulate these factors. We believe these will be the key areas of discussion, and we have been preparing for months to answer those questions.

One thing I'll just add is that we have two very strong Key Opinion Leaders (KOLs) joining us. They will be part of our presentation, presenting and answering questions. These individuals have a lot of credibility and are well known in the field, which is very helpful to us when questions are raised.

Great. Thank you so much for all the color, and we're looking forward to watching it. Good luck.

Yes. Thanks, Kelsey.

Please standby for our next question. Our next question comes from the line of Leland Gershell with Oppenheimer. Your line is open.

Hey, good morning. Thanks for taking my questions. Two from us. First, just wanted to ask, in the FDA review process, we are about a month away from the PDUFA date. Just wondering, given the AdCom is still pending, can you share any color on your recent interactions? Presumably you've had your late cycle meeting. Have you had the chance to discuss proposed labeling? I just wanted to ask if you're able to share any details there. And the second question for Mark or David: When you position UGN-102 to become, as you say, a foundational therapy in low-grade intermediate-risk patients, at the same time urologist adoption may begin with a certain type of patient profile. I'm just wondering what you see as the most likely patient profile for urologists to start using UGN-102 out of the 60,000 patients? What fraction might that be? Thank you.

Sure. Thanks, Leland, for the question. We feel very good about where we are with the FDA. We've had continuous interactions with them; they've been asking questions. You can tell by their inquiries where they are in the review. So we have no concerns about the PDUFA date. We don't want to get into a specific conversation about our discussions with the FDA. Suffice it to say that it's clear they are at the end of their review process, and we are in a very good position post-ODAC for swift action. As for the mid-cycle review conversation we had regarding the label and switching it to the recurrent patient population, that has simplified things for both our presentation and discussions with the FDA. We did not have a late cycle meeting, and we are not planning one. The mid-cycle review meeting was actually later than expected, but we don’t have a need for a late cycle meeting. So we’ll focus on that. I'm going to ask David to address the patient populations where we expect initial uptake.

Thanks, Liz, and thanks, Leland, for the question. Coming out of the gates, I'll share that we've done extensive market research with physicians, and they are really pleased with the clinical data we've shared on UGN-102. They find it compelling and see a need for it in their practices because of the multiple recurrences their patients experience. Coming out of the gates, we see three segments of the patient population. First is those with multiple recurrences; around 70% fall into this category. The second group is early recursers, and finally, we have patients who are unable to have surgery for various reasons like polypharmacy or intolerance to anesthesia. These are the primary populations we believe are ripe for uptake when we launch UGN-102. Importantly, UGN-102’s workflow fits seamlessly into urologist practices, requiring minimal training for administration. Appreciate the question.

Thank you. Please standby for our next question. Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is open.

Thanks so much for taking my questions. Just on the topic of the ODAC meeting, could you comment on two aspects in particular? Firstly, to what extent has there been communication regarding the purpose of the ODAC that pertains specifically to the lack of specific precedent for products being approved in low-grade intermediate-risk NMIBC? Do you expect that to be a meaningful topic of discussion at the ODAC meeting concerning UGN-102? Secondly, to what extent do you expect the precedent case of JELMYTO to aid and facilitate the discussion around UGN-102, possibly putting the committee in a more favorable light regarding familiarity with how UGN-102 works? Thank you.

Yes, great points, Ram. Mark, why don't you comment, and then I'll add some color as well.

Thanks for the insightful commentary. Regarding your first question, we believe it's implicit that the FDA has called for a public conversation about what the meaningfulness of this approach to this disease would be during this expert panel discussion. This has been anticipated for a long time in our approval process for UGN-102, given its unique treatment approach. We believe we have ample data to support the meaningful outcomes observed in our trials and the benefits to patients of having this treatment option. It's also worth noting that this would be the only urologic cancer therapy, to my knowledge, where patients have only one therapy option. Thus, UGN-102 could present patients with an alternative that many urologic cancer patients often possess in other settings, like prostate or kidney cancer. We believe we can effectively discuss this and address the issues involved. Now, regarding your second question about JELMYTO, our presentation will indeed remind the committee of its history and similarities in our approaches concerning active ingredients and delivery. This will help familiarize them with our case.

Yes, I agree. The ODAC panel will primarily consist of medical oncologists, many of whom may not be familiar with this disease or our treatments, so it's crucial to walk them through the ODAC and related information we need them to see, as Mark highlighted. Those are great questions, and we aim to address those comprehensively.

Just one quick follow-up. Can you update us on the current status of the UGN-103 clinical development program and when you expect the next material update on its progress? Thank you.

Yes, we're almost fully enrolled, and we'll share that soon. Over the next couple of months, we expect to conclude enrollment by the end of summer and provide the resultant data in 2026.

Please standby for our next question. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.

Hi. Thank you, and good morning, everyone. I had a question about how you may be thinking about the market for UGN-102. David provided some great color on the population size and opportunity, as well as expected greater patient population in the community setting. However, I was curious given the trend you're seeing with 340B utilization for JELMYTO. Is that a structural issue you also expect for the UGN-102 market? Any thoughts on that would be helpful, particularly regarding hospital pharmacy pricing. A second question for Mark regarding your earlier comments on advancing UGN-301: can you provide insight into how you're thinking about the criteria for a go or no-go decision for that program? Thank you.

Yes, the good news for UGN-102 is that we expect the 340B discounts not to be as significant as they are for JELMYTO, primarily due to your point that we doctor, expect that ultimately not at the beginning but down the line, approx 70% of our business will be in the community. So we're optimistic and expect 340B dynamics to be less of a headwind than it has been for JELMYTO. However, we have been conservative with our assumptions as we look at UGN-102 because JELMYTO has faced some significant issues in this regard; actual patient demand has been much larger, but we've experienced real challenges with 340B. Mark, would you like to address Paul’s second question?

Sure. As the audience recalls, 301 is our intravesical immunotherapy approach to high-grade disease, and it's in a Phase 1 study as both a monotherapy and in combination with our TLR7 agonist, UGN-201, as well as with gemcitabine. Since it’s a Phase 1 study, its primary focus is on tolerability and safety and not efficacy. That said, we have publicly stated that we’ve seen several responses, which is encouraging. However, it’s difficult to provide a specific number for a numeric bar we expect to meet. We are currently assessing patient durability of those responses, as we anticipate presenting this data later this year. At that point, we will evaluate what metrics will constitute a signal for us to move forward into a Phase 2 trial. My short answer is it's premature for me to provide a numeric benchmark, but we are seeing positive signals.

Yes, I would agree. The bar for efficacy and safety—particularly efficacy—is indeed higher than when we initiated our program. However, I still believe there is a considerable opportunity in high-grade disease for several reasons. For instance, these patients are not cured and continue to experience recurrences, meaning they require additional treatments. Furthermore, the current programs achieving higher complete response rates do so because they require continuous dosing. Thus, there remains an opportunity for a treatment model, akin to UGN-102 in intermediate-risk cases, where a set treatment duration leads to a treatment-free period. We need to be strategic and critical before embarking into a costly Phase 2 or Phase 3 study with UGN-301. Additionally, we need to take 501 into account as it adds excitement to the strategy. We're focused on determining the timeline and manner of our next steps. As Mark stated, it’s a bit too early to discuss specifics, but we acknowledge that the efficacy bar is higher now, and we believe both approaches can potentially meet that standard.

Great. Thank you for the insight.

Thank you. Please standby for our next question. Our next question comes from the line of George Farmer with Scotiabank. Your line is open.

Hi. Good morning. Thanks for taking my questions. A few from me. Can you confirm that the FDA representatives you've been speaking with are still employed by the agency? That's number one. Number two, regarding the 18-month data you presented at AUA, will that be included in the discussion at ODAC? And number three, do you see a need or plan for any sort of direct-to-consumer advertising campaign?

Yes, great questions, George. First, the FDA team is indeed still in place; they're the same people we've been working with since JELMYTO, so hopefully they’ll remain until the end of the process. Regarding the 18-month data, that has already been shared with the FDA prior to becoming public; they have had access to that data, so it's part of our discussions. I'm sorry, I forgot the last question.

Direct-to-consumer.

Regarding direct-to-consumer efforts, I wouldn't expect broad-based initiatives initially, but we will certainly engage with patients. We've repeatedly mentioned that 90% of patients prefer UGN-102 to a TURBT. These patients have experience with both UGN-102 and TURBT, and we want to ensure they understand their options when physicians present alternatives. We will engage with these patients, but broad direct-to-consumer campaigns are not anticipated at this time.

Hi. Good morning, everyone. Thank you for taking our questions. I got a couple. This might be a bit unconventional, but could you clarify what happens to patients who progress on UGN-102? For example, what is the plan if 20% to 25% don't respond? Would they switch back to TURBT, or would you redose them with UGN-102?

Yes, Mark, do you want to take that?

Sure. Fortunately, very few patients progressed during treatment in this program. Progression refers to a low-grade patient turning into someone with high-grade disease or invasive disease, which is quite rare. For those who responded but had recurrence or didn't completely respond after treatment with UGN-102, using transurethral resection to remove remaining tumors is not associated with any unusual complications. The standard of care from our experience with the clinical trials indicates that there shouldn't be issues from prior UGN-102 use. As for treatment protocols moving forward after approval, I will defer to Liz to share her insights on that.

Yes, I think your expectation is right. After a patient achieves a positive response, if they experience recurrence, a physician generally would likely retreat with whatever treatment they used initially. We plan to launch either a Phase 4 study or registry option to generate data on the impacts when patients recur while being treated with UGN-102 or after TURBT. This data will be essential in understanding how UGN-102 performs in follow-up scenarios. I anticipate a parallel to other cancer treatment protocols.

Thank you. I appreciate that. Another question pertains to commercial aspects. Could you clarify the gross-to-net (GTN) for JELMYTO, and what expectations do you have for UGN-102?

Aydin, we've maintained a gross-to-net in the mid-70s percent for JELMYTO. The headwinds we faced regarding 340B are starting to annualize, meaning that their impact on year-over-year growth should lessen. Regarding UGN-102, we expect a more favorable gross-to-net profile relative to JELMYTO, as community utilization should increase over time. Initially, usage may be hospital-centric, but that will shift toward community treatment models.

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back to Liz for closing remarks.

Well, thanks, everybody. As you can imagine, there's a lot of excitement over here as we prepare for the ODAC next week. We appreciate all of your support—it's been a long time coming, and we are thrilled about the forthcoming opportunity. Most importantly, these patients need new options, and we're very much looking forward to next week, and then subsequently the PDUFA. So thanks, and we'll keep you guys informed of any developments. We'll talk to you soon. Bye-bye.

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.