Q2 2026 UroGen Pharma Ltd Earnings Call

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during a session, you'll need to press star 11 on your telephone.

Speaker #1: You'll then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded.

Speaker #1: I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

Speaker #2: Thank you, and good morning, everyone. Welcome to UroGen Pharma's second 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 June 30, 2026.

Speaker #2: 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.

Speaker #2: On today's call, we will be making certain forward-looking statements. These may include among other things statements regarding our ongoing commercialization activities related to the dairy and gel mito, ongoing and planned clinical and non-clinical trials, commercial and clinical development milestones market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings, and decisions.

Speaker #2: The importance of the story's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates, and all future R&D efforts and milestones—our corporate goals, and 2026 financial guidance.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Liz?

Speaker #3: Good morning, and thank you all for joining us today. I'm so pleased to share the results for another strong quarter. Driven by continued momentum across the story launch and meaningful progress advancing our long-term growth strategy.

Speaker #3: The story generated 50.4 million dollars in net product revenue during the second quarter. Representing a 73% growth over the first quarter. More importantly, the commercial trends underlying that growth continue to strengthen.

Speaker #3: We are seeing expanding adoption across both hospital and community practices, increasing repeat utilization, and growing physician confidence, all of which reinforces our confidence that we are building a meaningful commercial franchise.

Speaker #3: That progress reflects the compelling value proposition of the story. As the first and only FDA-approved medicine for adults with recurrent, low-grade, intermediate-risk, non-muscle invasive bladder cancer, the story offers patients a treatment that provides unprecedented recurrence and treatment-free intervals.

Speaker #3: The story is a primary non-surgical option for a disease that historically had been managed through repeated surgical intervention under general anesthesia. We believe its unique clinical profile is changing how physicians think about treating these patients and increasingly establishing the story as a foundational treatment in this setting.

Speaker #3: As the prior quarters, I'd like to provide an update on the operating metrics that we track most closely. As they continue to provide valuable insight into the trajectory of the launch.

Speaker #3: As of June 30th, 2026, we had 1,444 activated accounts. Up from 972 at the end of the first quarter. Unique prescribers increased to 452 compared to 256 in Q1, while repeat prescribers nearly doubled to 204.

Speaker #3: Importantly, repeat prescribers now represent approximately 45% of riders, compared with around 40% in the first quarter. We continue to view repeat utilization as one of the strongest indicators of potential long-term success.

Speaker #3: It demonstrates that physicians are gaining confidence through real-world experience and increasingly incorporating the story into routine clinical practice. Equally encouraging, these trends remain consistent throughout the quarter.

Speaker #3: Giving us confidence the launch is advancing and increasingly sustainable. We continue to see increased utilization within existing accounts, demonstrating that adoption is expanding across practices and within them.

Speaker #3: Patient enrollment forms are increasing, and new patient starts are tracking in line with that growth. Operationally, we continue to improve the time from patient enrollment to treatment initiation.

Speaker #3: As practices gain familiarity with ordering, reimbursement, and administration, workflows continue to become more efficient. Our goal is to achieve the 2 to 3 week enrollment to treatment conversion cycle we see today with gel mito.

Speaker #3: And we expect continued progress toward that goal over the balance of the year. Another encouraging trend is expansion into community urology practices. By the end of the quarter, approximately 55% of utilization was in community practices, compared to 45% from hospitals.

Speaker #3: This is important because we estimate approximately 70% of the addressable market resides in the community practices. As adoption continues to broaden, we believe the community setting will become an increasingly important driver of long-term growth, and we still see significant runway ahead.

Speaker #3: From an access perspective, we have open access across more than 95% of covered lives, and we see no material reimbursement barriers. The permanent J code has performed exactly as anticipated by improving reimbursement confidence and enabling broader utilization.

Speaker #3: At this stage, reimbursement uncertainty is no longer a meaningful constraint to adoption. Looking ahead, we believe there remains a significant opportunity to build on this momentum through the remainder of 2026 and beyond.

Speaker #3: Our priorities remain clear: expanding community adoption, increasing repeat utilization, continuing improvement of patient conversion, and increasing awareness among both physicians and patients. We are beginning to invest more directly in patient awareness.

Speaker #3: Many patients with recurrent, low-grade, non–muscle invasive bladder cancer are not aware that a non-surgical treatment option exists, and we believe increasing that awareness represents an important opportunity to expand utilization in the mid- to long-term.

Speaker #3: Turning to gel mito, revenue was 22 million in the second quarter, compared to 21.7 million in the first quarter. Gel mito continues to demonstrate a stable and predictable demand profile, while also continuing to add new users.

Speaker #3: We believe we're on track to deliver within our full-year revenue guidance of $97 to $101 million. During the quarter, we continued to strengthen the long-term foundation of our uro-oncology portfolio.

Speaker #3: We reached a settlement and license agreement with Teva that resolved the gel mito patent litigation, providing greater visibility into the product's long-term commercial runway, while reinforcing the strength of our R2 gel intellectual property portfolio.

Speaker #3: In addition, we received a notice of allowance from the U.S. Patent and Trademark Office for a new method of treatment patent covering both the story and UGM 103.

Speaker #3: This patent, once issued, is expected to provide protection into July 2044, strengthening the intellectual property supporting the franchise and reinforcing the long-term commercial opportunity for both products.

Speaker #3: We continue to make meaningful progress across our pipeline. UGM 103 remains on track for NDA submission in the next few weeks. UGM 104 continues progress through phase 3 and following FDA acceptance of our IND, we're excited to begin phase 1 development of UGN 501 this year.

Speaker #3: Overall, the first half of 2026 has significantly strengthened our conviction in the long-term opportunity ahead. We are successfully scaling the story launch, advancing multiple pipeline programs, and building a company position for sustained growth.

Speaker #3: We believe this positions UroGen to deliver meaningful outcomes for patients while creating significant long-term value for shareholders. With that, I'll turn the call over to Mark for a clinical update.

Speaker #3: Mark?

Speaker #2: Thank you, Liz. And good morning, everyone. Let me begin with the most recent update from the phase 3 Envision trial. In May, we announced updated durability data from Envision with nearly 3 years of follow-up.

Speaker #2: Among patients who achieved a complete response at 3 months, the probability of remaining disease-free at 36 months was 64.5% by Kaplan-Meier estimate. Importantly, at a median follow-up of 35.5 months, the median duration of response has still not been reached.

Speaker #2: The most important takeaway is that the complete response obtained with this therapy is highly durable through three years, and was achieved without any maintenance therapy.

Speaker #2: In practical terms, by Kaplan-Meier estimate, most complete responders remain disease-free nearly 3 years after achieving a complete response. For a disease characterized by repeated recurrences, and repeated surgeries, these data highlight the story's potential to interrupt that cycle.

Speaker #2: The clinical data are important, but equally important is that we are now seeing similar results in routine clinical practice. At the American Urologic Association annual meeting in May, we hosted a panel of leading academic and community urologists to discuss their real-world experience with the story.

Speaker #2: The discussion provided strong corroboration of both the clinical profile and commercial adoption we are seeing today. Several consistent themes emerged. First, the panelists described the story administration as easy to integrate into routine urology practice, without meaningful disruption to existing workflows.

Speaker #2: Second, as physicians gain experience, they are becoming increasingly confident in expanding use beyond their initial patients. Rather than reserving the story for patients who may not be ideal surgical candidates, many are now considering it earlier for a broader range of patients with recurrent low-grade intermediate risk disease, including younger and otherwise healthy patients who simply wish to avoid repeated TURBT procedures.

Speaker #2: And finally, the panel also discussed how they expect the story to fit within the evolving treatment landscape. Their view is that physicians will continue to prioritize therapies that combine durable efficacy with ease of administration, minimal disruption to practice workflow, and a finite treatment course.

Speaker #2: We believe these characteristics position the story favorably as the treatment landscape continues to evolve. The event also included a patient perspective, one that reinforced what we heard from physicians.

Speaker #2: She described the burden of repeated recurrences and multiple TURBT procedures before she received the therapy, as well as the impact that achieving a durable complete response had on allowing her to return to her normal life.

Speaker #2: We believe it reflects the experiences of many patients now being treated with the story, and it's a reminder of why we think the opportunity here is so meaningful.

Speaker #2: For those of you who are unable to join the live event, a replay is available on our website. While the commercial launch continues to validate the story in clinical practice today, we remain equally focused on expanding the leadership through our next-generation pipeline.

Speaker #2: UGN-103 represents our next-generation investigational medicine for recurrent, low-grade, intermediate-risk NMIBC, and we remain on track to submit our NDA in the third quarter of 2026.

Speaker #2: As we announced previously, the phase 3 Utopia trial demonstrated a 6-month duration of response of 94.5% by Kaplan-Meier estimate, which is generally consistent with the 91.9% 6-month durability observed with the story in the pivotal Envision trial.

Speaker #2: We continue to believe these data support the regulatory pathway for UGN 103, and we remain aligned with the FDA on our planned NDA submission.

Speaker #2: Looking beyond the initial indication, we continue to expand the long-term opportunity for UGN productive type C meeting with the FDA, we plan to initiate a phase 3 trial later this year to evaluate UGN 103 in high-grade NMIDC and in the adjuvant setting for newly diagnosed patients, with low-grade intermediate risk disease, which remains on track for 2027.

Speaker #2: Our phase 3 program for UGN 104 in low-grade upper tract urothelial cancer continues to progress well, and we expect to complete enrollment by the end of 2026.

Speaker #2: UGN 501 is our investigational next-generation oncolytic virus, being developed for high-grade NMIDC. In July, the FDA cleared our IND, and we expect to initiate a phase 1 trial later this year.

Speaker #2: What continues to excite us about this program is its differentiated biology. UGN-501 is engineered to combine direct tumor cell destruction with a subsequent immunomodulatory effect, providing what we believe is a unique mechanism among oncolytic viruses currently in development.

Speaker #2: Our non-clinical studies demonstrated broad cytotoxic activity across multiple bladder cancer cell lines, reinforcing our belief that UGN 501 has the potential to become a differentiated therapy in this space.

Speaker #2: The phase 1 trial will initially evaluate intravesical administration while future development will explore delivery using our RTGL technology to potentially extend dwell time and enhance local activity.

Speaker #2: And with that, I'll turn the call over to Chris to review our financial results. Chris?

Speaker #3: Thank you, Mark, and good morning, everyone. Total revenue was $72.5 million in the second quarter of 2026, compared with $24.2 million in the second quarter of 2025.

Speaker #3: This increase was driven by the continued commercial launch of UGN-102. Research and development expenses were $17.3 million in the second quarter of 2026, compared with $18.9 million in the same period last year.

Speaker #3: The decrease in R&D expenses was primarily attributable to the story manufacturing costs, which were recognized as an R&D expense in the second quarter of 2025 prior to receiving FDA approval.

Speaker #3: Selling, general, and administrative expenses were $48.4 million in the second quarter of 2026, compared with $43.2 million in the same period last year. The increase in SG&A expenses was primarily attributable to the story commercial activities, including the Salesforce expansion following the story approval and higher brand marketing expenses, and an increase in overall commercial operation costs.

Speaker #3: We recorded 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 second quarter of 2025.

Speaker #3: Interest expense on our long-term debt was $4.9 million, compared with $4.1 million in the same period last year. We recorded the net loss of $14.4 million or $28 cents per basic and diluted share in the second quarter of 2026, compared with a net loss of $49.9 million or $1.05 per basic and diluted share in the second quarter of 2025.

Speaker #3: As of June 30, 2026, we had $108 million in cash, cash equivalents, and marketable securities. Turning to guidance, we continue to expect Germito net product revenue of $97 to $101 million for 2026, which represents growth of roughly 3% to 7% over 2025.

Speaker #3: As we have noted prior, we are not issuing full years of story guidance while the launch is still in its early stages. We are increasing our full-year operating expense guidance to $260 to $270 million including approximately 20 to 24 million of non-cash share-based compensation expense.

Speaker #3: This increase reflects our decision to accelerate investment behind the business in response to the continued strength of the story launch. Specifically, we plan to increase investment in the story healthcare professional promotional education and patient awareness initiatives to support long-term commercial adoption and also accelerate startup activities for the UGN 103 high-grade trial and development activities to explore UGN 501 with our RTGL technology.

Speaker #3: We view these as disciplined, high-return investments that have the potential to strengthen the long-term profile of the business. Importantly, this increased investment does not change our confidence in reaching profitability with our existing capital resources.

Speaker #3: That concludes our remarks. We will now open the call to questions.

Speaker #1: Thank you. At this time, we will now conduct the question-and-answer session. As a reminder, to ask a question, you'll need to press star at 11 on your telephone and wait for your name to be announced.

Speaker #1: To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Raghuram Selvaraju of HC Wainwright & Company.

Speaker #1: Your line is now open.

Speaker #4: Thanks so much for taking our questions and congratulations on a highly impressive quarter. I was wondering if you could provide us with some additional color regarding the demand level that exists for the story at the community hospital setting, how the story might potentially be viewed as a privileged product and attractively priced and highly impactful product at the community hospital level, and how the community hospital setting compares in terms of overall market size opportunity to the opportunity that exists for the story at the academic center level.

Speaker #4: Thank you.

Speaker #1: Hi, Raj. Just thanks, and thank you for your comments. I want to just make sure when you're saying community hospital, you're really talking about community practices, right, not necessarily community hospital.

Speaker #4: Right. Community practices. Community practices. Community practices, yes.

Speaker #1: Okay. Yeah. Yeah, yeah. So, look, at the end of the day, what we've said in the remarks is that we know that most patients—whether it's around 70% of patients—are actually seen in the community setting.

Speaker #1: So getting to the community setting is obviously a very key for us. You have your LUGPOS, your large group practices. We also have a lot of practices that have now been consolidated under a lot of the PEs.

Speaker #1: But for the most part, they all work independently. They operate really independently. So, while there's a huge opportunity there, there's also a lot of work that has to get done to operationalize that, particularly with a therapy such as ours.

Speaker #1: So, we're just really scratching the surface of the opportunity in community practices. They get it. The financial piece of it—they get the fact that adding this, quote-unquote, "service line," as they call it, is great for them to attract patients.

Speaker #1: So, there's a lot of reason to do it, but again, the adoption is still really, really early. Academic centers, I think, for the most part, you see a faster uptake in those areas, but they don't see the majority of the patients.

Speaker #1: So they want to be at the forefront of medicine. They want to be at the forefront. They want to be doing these things as much easier for them to operationalize because they're not having to deal with the pharmacy deals with most of it.

Speaker #1: So I think what I'll say is that we see uptake across the board in all types. We see the biggest opportunity for accelerating growth to bring on some of these large group practices.

Speaker #1: Once you really get it integrated into their practice, where they're using it all the time, that's going to be the biggest that's the biggest driver of any inflection.

Speaker #1: We hear a lot about inflection, but the reality of it is we've talked about this before. Urology's slow. They're a slow compared to oncologists.

Speaker #1: So even though we had a great quarter, we're really thrilled with where we are. There's still so much opportunity out there for us to accelerate growth.

Speaker #1: So, I hope that helps to understand kind of the way that they're looking at it, we're looking at it, but also the way community practices look at it versus academic centers.

Speaker #4: No, that's very helpful. And then just very quickly, I was wondering when you believe you might be in a position to provide the story revenue guidance, if you're thinking about doing that before the year closes.

Speaker #4: Or failing that possibly to start off 2027. Also wanted to see if you've felt you had a handle at this point on the timing of release of the phase three trial of UGN 104.

Speaker #4: And this is something that I've asked before. If you're seeing, with the added momentum behind the story, any meaningful sort of spillover positive impact on Jelmyto uptake at this time?

Speaker #4: Thank you.

Speaker #3: Just on the guidance front, Rob, thanks for the question. We're pleased with the progress, obviously, but it still remains in the early stages. So we think it's prudent to allow the demand trends to play out through the rest of this year before we consider introducing formal guidance for the story.

Speaker #3: So, I would think more for next year in terms of the story guidance.

Speaker #4: The 104?

Speaker #3: Yeah. 104 is on track, as you know. To complete enrollment this year, and it will follow by about a year in terms of the approval process, the 103 initiative.

Speaker #3: But we're very bullish on the uptake of that as well as the success or molecule to Gelmiro.

Speaker #1: Yeah. And look, to answer your question, no. We have not seen the what I call a reverse halo. On Gelmiro, we've sort of you can look at it both ways.

Speaker #1: On one side, the priority, frankly, for the sales team—and our incentive—they are incentivized at the story as the priority. And we made that decision.

Speaker #1: We believe that's the right decision. Having said that, obviously, we want to continue to drive Gelmiro revenue, but also give patients the opportunity. So we are seeing I would say that we are seeing some new doctors use Gelmiro that had not used Gelmiro when we go to talk to them initially about the story.

Speaker #1: But do I believe that overall we've seen this real halo effect on Jelmyto? We have not seen that. Do I hope that we will?

Speaker #1: Yes, absolutely. By the by going to more doctors, what we are seeing this year is we are seeing a lot of clinical trials, as you guys know.

Speaker #1: There's a lot of competitors coming into this space, and they're really focused on enrolling in the US. So we have seen our own UGN 104 study as well as competitor studies taking patients that likely quite a few of those would have been Gelmiro patients.

Speaker #1: So, it's kind of hard to tell at this point, but we don't believe that we've seen this reverse halo.

Speaker #4: Thank you and congrats again.

Speaker #1: Thanks, Rob.

Speaker #2: One moment for our next question. Our next question comes on the line of Tara Bancroft of TD Callan. Line is now open.

Speaker #5: Hi, good morning. I also want to offer my congratulations on the very strong quarter. It obviously far outperformed linear growth metrics that we were all thinking of.

Speaker #5: So I'm curious to hear in what metric or factor, particularly drove that acceleration and growth that you're seeing the most, especially compared to last quarter, and then based on that, how should we think about growth throughout the rest of the year?

Speaker #5: Maybe continued acceleration, linear, or something else? And yeah, thanks.

Speaker #1: Great. Thanks, Tara. I'm going to ask Chris to comment, and then I'll add any commentary.

Speaker #3: Thanks, Tara. Sure. And as Liz mentioned in the prior question, urologists tend to be slower to adopt, and they'll try it on one or two patients and then expand to other patients.

Speaker #3: And that was the reason for our linear growth expectation. And we did outpace that a bit in Q2. We do expect there can be some quarter to quarter variability.

Speaker #3: I mean, one thing we're watching is potential summer seasonalities as an example. But nothing specific, Tara, in terms of what's driving kind of the slightly faster than linear growth within Q2.

Speaker #3: I think we've just seen consistent growth across all the commercial metrics, which just gives us confidence in the sustainability of the growth trajectory. But I just think, look, we're going to have some quarter to quarter variability, but still think the linear growth profile is the right way to think about it from now until peak.

Speaker #1: Yeah. And I think we just want to be a little bit cautious on Q3. We do expect growth, and yeah, we're expecting we'll continue that quarter over quarter growth.

Speaker #1: But your comment about acceleration, we do not expect to see that. Particularly in Q3, we're hopeful, right, as we continue to grow throughout the year that we will see continued acceleration.

Speaker #1: But given what we've seen so far, we're comfortable with where we are, comfortable with our comments around linear growth in Q3. And so that's kind of where we are.

Speaker #1: So feel good about it. I would not say acceleration. At least not in Q3. And we'll continue to share whatever we can as much color as we can as we get into the rest of Q3 and into Q4.

Speaker #5: Great. Thank you so much.

Speaker #1: Thanks, Tara.

Speaker #2: One moment for our next question. Our next question comes from the line of Kelsey Goodwin of Piper Sandler. Your line is now open.

Speaker #6: Oh, hey. Good morning, guys. Thanks for taking our question. And congrats on a really great quarter. That's awesome. 2 months from us yeah, yeah, of course.

Speaker #6: Congrats again. 2 months from us, the first one, based on your channel checks, after how many TURBTs are patients getting the story now? And do you have a sense for what the split is among the story users that are eligible versus ineligible for surgery?

Speaker #6: And then, second, I think you've mentioned in the past some physicians—urologists—being hesitant to try new things. They get more comfortable kind of trying the story in the adjuvant setting.

Speaker #6: Are you still seeing that? Are you seeing physicians start to move away from that? And how do you kind of see that trend evolving over time?

Speaker #6: Thanks so much.

Speaker #1: Yeah, great. Look, at the end of the day, I think that we're still very early. Again, in the launch, I think that if you look at and again, this is all anecdotal, right?

Speaker #1: So we're not tracking. We did do some chart reviews. And the good news is you're seeing the usage across everybody. So you're seeing usage after one, after two, after three, after five, after 40, believe it or not.

Speaker #1: TURBTs. So we are seeing it across the board. So we are not seeing physicians only treat patients that are ineligible for surgery. Mark's probably going to tell you no one is really ineligible for surgery.

Speaker #1: At the end of the day.

Speaker #3: That's what I'm going to tell you. Almost nobody.

Speaker #1: Right. So there's this would rather not put them under general anesthesia. So I would say a very small portion of them are quote-unquote just ineligible patients.

Speaker #1: But you do have a large portion of them, but less than 50% are what we would call, per their comorbidities, 'prefer not to put them through surgery.'

Speaker #1: They're really using it across the board, like I said. The adjuvant versus non-adjuvant, what we are hearing is as physicians get experienced, they're more comfortable using it in primary.

Speaker #1: Again, anecdotally, primary. So we know that some physicians still do the surgery first and then come back a few weeks later. But for the most part, we're seeing more and more of them using it without surgery, which we think is great.

Speaker #1: And Chris talked about our operating expenses growing up this year. One of the things we're doing is investing more into developing programs for patients because patients don't want to go through surgery.

Speaker #1: And so I think the more patients can be vocal about that with their doctors, I think you'll see that even more. But look, it works either way.

Speaker #1: We don't promote adjuvant. If a doctor chooses to use it in the adjuvant setting, as long as they get reimbursed and there's no restrictions, they can do so.

Speaker #1: And so we see it both ways. But again, keeping in mind that one of the greatest benefits is that you don't have to go through surgery.

Speaker #1: So hopefully that's helpful.

Speaker #6: Yeah, that's great. Thank you so much. And maybe just to flip one last one in quickly. One question I get often from investors is just kind of what are your updated thoughts on profitability and are you still comfortable with cash two and through profitability at this point?

Speaker #6: And that's it from me. Thank you so much.

Speaker #3: The question, Kelsey, and the answer is yes. We are still confident in that our capital resources will get us to and through profitability.

Speaker #1: Yeah. I mean, look, the only comment I'll make about that is we've been very disciplined with our spending, right? We have not shorted the launch at all from a resource perspective.

Speaker #1: But there are a lot of things we've been wanting to do and loving to do. And but we wanted to wait to make sure we solve the revenue coming in.

Speaker #1: So to Chris's point, and he made it in his comments, this is not our incremental spend, which isn't a huge incremental. But it does not change our path to profitability.

Speaker #6: Okay, perfect. Thank you so much. And congrats again.

Speaker #1: Thanks, guys.

Speaker #2: One moment for our next question. Our next question comes from the line of Leland Gershell of Oppenheimer. Your line is now open.

Speaker #7: Great. Thanks. And good morning, Liz and the team. Let me also add my congratulations on the story number. It certainly makes sense to be furthering support for this key growth driver.

Speaker #7: A couple of questions. I wanted to ask, Liz, in the past, I think you've said that you see a billion dollars or maybe over a billion dollars in total revenue for UroGen en by the end of the decade.

Speaker #7: I'm wondering if there's any contemplation of potentially revising that number upward given the strong sales trajectory. And also wanted to ask just as sort of an further out question, but when you make the transition in the marketplace, from the story to 103, and I guess the same would apply in Fragile Mito 104, if you could just sort of walk us through what that mechanically will look like, presumably you'll wait for not just the approval, but the J code and then you will add introduce one product and then withdraw the prior one.

Speaker #7: Just wanted to ask about that. Thank you.

Speaker #1: Yeah, sure. Absolutely. And thanks, Leland. We appreciate your support over the years. Let me be really clear. What I've always said is 1 billion plus so it's a and we've said 1 billion plus only on the story.

Speaker #1: So when you think about it from a total perspective, yes, do I think there's an opportunity to blow that away? Yes, I do. I absolutely do.

Speaker #1: I think a lot of it depends on timing and physicians and experience, which so far has been very positive. And we obviously do a lot of quantitative research and talk to docs just like you guys do.

Speaker #1: And what we've said all along is that a 20% market share for this story is a $1.2 billion market. Do you believe there's opportunity to do significantly more than that?

Speaker #1: Yes, sure there is. Absolutely. But what we've committed to is that it's a 1 billion dollar plus market product with just a story alone.

Speaker #1: As we the switch, I think the great news with the patent extension, something we've been working on for a long time, kudos to our legal team here.

Speaker #1: And to get that additional patent on the story, I think gives us a lot of flexibility as we transition the story to UGM 103.

Speaker #1: And John Mito to 104 and obviously not in the same situation. So just talking about the story, we will, to your point, absolutely wait until we have a J code and there'll be we're working right now on what the clear strategy is.

Speaker #1: There'll be a time period when they're both on the market. But UGM 103 has a lot of benefits from a production standpoint, a manufacturing ensuring supply extended dating on the drug.

Speaker #1: So there's just a lot of benefit to 103, so we'll want to switch to that as quickly as possible. But we'll do it in a way that doesn't jeopardize any adoption by doctors or availability for patients.

Speaker #1: And the same thing with John Mito and 104. Obviously, a little bit more pressure there. To do it quicker. But we don't really see that being a huge issue there.

Speaker #1: It's a smaller patient population. Smaller physician population. So probably easier to switch. But I just want to I can't underscore enough how great it was to get the additional patent on the story and give us freedom to operate through 2044.

Speaker #1: So whether it's the story or UGM 103, we're in it for the long haul. So I hope that helps, Leland. Thanks.

Speaker #7: Oh, yeah. Thanks very much.

Speaker #2: One moment for our next question. Our next question comes from the line of Amin Makaram of Jefferies. Your line is now open.

Speaker #8: Hi. Thanks for taking our questions. And congrats on the quarter. One question here. With the number of sites activated so far, which is around 1,400, and then you have around 450 prescribers, just wanted to understand how quickly you can close the gap between the prescribers and the sites activated.

Speaker #8: And how many eligible patients do you expect to have within this 1,400 activated sites?

Speaker #9: Yeah. Maybe this is Chris. Just from the site activation piece, remember the site activation is sites that are operationally ready to be able to administer the story.

Speaker #9: So they're through the credit checks on board with their specialty distributor. And they're ready to go. And so we spent a lot of time last year building the foundation of getting sites activated and ready to use the product.

Speaker #9: And we'll continue to add new sites as you're seeing between Q2 and Q1. But in terms of the adoption and the conversion of sites activated to physician utilization, really, I would focus more on how physicians are coming online in terms of that linear growth trend and adoption curve.

Speaker #9: And so again, we feel good about the number of sites that we have ready to go. But we are really from a focus perspective, I would be pointing to the HCP adoption rate.

Speaker #8: Thanks.

Speaker #1: Appreciate it. Thank you.

Speaker #2: One moment for our next question. Our next question comes from the line of Michael Schmidt of Guggenheim. Your line is now open.

Speaker #10: Hey, guys. Good morning. Thanks for taking my question. I had a pipeline question around UGN 103. So with the plan phase three study in high-risk NMIVC starting later this year, maybe just comment about how you think about the competitive landscape there, which is obviously different than in the low-grade space.

Speaker #10: And how is UGN 103 positioned in the high-risk category relative to other available and emerging therapies? Thanks so much.

Speaker #9: Thanks very much. It's Marc. So the study that we're going to begin this year in high-grade disease focusing particularly on papillary disease where we think there is a particular opportunity will be an adjuvant study compared to an active control TRBT plus intravascular chemotherapy.

Speaker #9: And the value proposition is going to be very familiar because the benefit of 103 is an active agent that we know is active against urothelial cancer in extended dwell time.

Speaker #9: And that study will include not only induction therapy, but maintenance. So we believe that compared to conventional chemotherapy, which as you know is aqueous, the advantage of delivering in the RT gel platform will be obvious.

Speaker #9: And should convey a benefit to patients with this disease compared to those who are treated with aqueous chemotherapy. So it remains incumbent upon us to prove that in the study.

Speaker #9: But we're optimistic that 103 in this context will provide an advantage compared to conventional therapy. Let me stop there and make sure I've answered your question.

Speaker #1: So much competitors.

Speaker #9: Yeah. Thank you.

Speaker #1: What is this size of that?

Speaker #10: Opportunity? Sorry.

Speaker #9: What are we saying about the size of the opportunity?

Speaker #1: The size of the papillary? I mean, look, within high-grade, obviously there's a lot of different patient segmentations and populations. Everybody's talked about it being a multi-billion dollar market.

Speaker #1: And it's a big portion percentage of that. It's actually the majority of the patients, right? So the majority of the patients don't have are in this papillary area.

Speaker #1: So the reality of it is there's a lot of opportunity. From a competitive standpoint, we often talk about it being a highly competitive. But the reality of it is if you look at bladder cancer, compared to most other oncology drugs, there's still very, very few people in that space.

Speaker #1: When you look at it and comparison and who's actually with the data looks like, we think there's a real opportunity for us with UGM 103 to not only at least be as good or better than the incoming the players that are there now, we believe we can beat.

Speaker #1: The ones that are coming in, we think we can at least do as well from an efficacy standpoint. But we believe that from a safety AE profile and ease of use perspective, that we will have many benefits.

Speaker #1: And let's not forget that these patients these are this is going to be a chronic disease for these patients. They hopefully don't want to go through a radical cystectomy.

Speaker #1: And therefore, they are going to cycle through multiple therapies. And what we're hearing is that there's still a lot of opportunity for these patients to cycle through.

Speaker #1: So the opportunity there also is as big as it is in low-grade because from our perspective, the pricing you're getting not only your six weeks, but you're getting maintenance therapy as well.

Speaker #1: So even though our price per dose is significantly less than some of the competitors, you're still looking at a fairly large market considering the pricing takes into consideration maintenance.

Speaker #1: So, from a pure business opportunity, it's there. But from a patient opportunity, absolutely, these patients need more options. Thank you. Thanks, Michael.

Speaker #2: One moment for our next question. Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is now open.

Speaker #11: Hi. This is Eric on for Paul Choi. Thanks for taking my question. I just wanted to elaborate a little bit more on the sequencing of adjuvant therapies here.

Speaker #11: As you were mentioning in the previous answer, as competitive oncolytic immunotherapies begin, establishing adjuvant treatment roles and the intermediary segment, how do you expect your all just to sequence this story upon recurrence?

Speaker #11: Do you think they will bypass adjuvant treatments entirely in favor of this story? Or how do you perceive the treatment algorithm evolving?

Speaker #9: This is Mark again. And thanks for asking that question. This actually came up during our panel discussion at the AUA. And for those of you who haven't seen that, the link is on our website.

Speaker #9: The panelists, and I shared their opinion believe that now that this story is available, the likely sequence of events will be the following. Patients will come in for an initial presentation with tumor and undergo a TRBT, which will provide a diagnosis and staging.

Speaker #9: If the patient has low-grade, intermediate-risk disease upon recurrence, we know from a variety of publications from the recent literature that those patients have a very low likelihood of progression, and an exceedingly high likelihood of recurrence subsequently if they are treated using the standard of care, i.e., TURBT.

Speaker #9: And so the panelists believe that what will happen upon recurrence increasingly as physicians become more familiar with this story is that this story will become the default next therapy when a patient fails or recurs following TRBT.

Speaker #9: If a patient develops a long-term disease-free interval following this story, there's no reason to believe upon recurrence again should one occur that the patient couldn't be retreated with this story, although we don't have information about that yet.

Speaker #9: Though it's likely to emerge as we track this practice as it evolves. But if patients demonstrate a refractory response to this story, then the physicians believe and I think this is correct that other therapies will be used in adjuvant, namely the patients will then undergo another TRBT and then have some other agent introduced intravascularly.

Speaker #9: But the story looks like it's going to emerge as the next thing to do when a patient recurs after the first TRBT.

Speaker #11: Got it. Very helpful. Thanks.

Speaker #1: Yeah. We feel very confident in that, given not only the recurrence-free, but also the treatment-free, that Mark talked about and we talk about often. Six weeks and you're done, right?

Speaker #1: No surgery if you don't need so. And right now, we are past 36 months and still haven't hit the median. So I like to challenge anyone to meet or beat those that type of data out in the marketplace.

Speaker #1: But thanks for your question.

Speaker #2: One moment for our next question. Our next question comes from the line of Kevin DeGreeter of Leidenberg Thelman. Your line is now open.

Speaker #12: Hey, Greg. Yeah. Thanks for taking our question. I just have one on a 501. Can you walk me through the thinking on how to characterize in addition to the safety profile kind of go/no-go from the phase one?

Speaker #12: Should I think about replication, sort of within the cells, as being interesting and going forward? Efficacy parameter—just, how do I think about the most relevant learning from phase one?

Speaker #12: And I guess related, is there an opportunity for a meaningful update in 2027? Thanks.

Speaker #9: Thanks for the question. So we're excited about 501 in large part because of its differentiated biology. It is a interesting oncolytic virus specifically engineered to act initially like a chemotherapy.

Speaker #9: So it will be highly cytolytic initially, and that will then lead to a secondary immune response. We have a lot of pre-clinical and additional clinical data to suggest that 501 is going to be very active. Our pre-clinical data, in particular in bladder cancer cell lines, suggests that it is very active against a wide variety of urothelial cancers in vitro.

Speaker #9: So we're expecting it to be active in humans as well. As you know, as everybody knows, phase one studies are primarily focused on safety and tolerability, not efficacy.

Speaker #9: But we will be searching for efficacy signals in the population of patients we're going to study, namely those with high-grade noninvasive disease. And so that will help us inform what phase two looks like.

Speaker #9: I think that's probably the most we could say right now. But I'd defer to Liz as to how she's thinking about it as well.

Speaker #1: No, I agree. I think we'll see what the data says. But we have very, very high expectations about it and do think that we'll have data meaningful data in 2027.

Speaker #12: Great. Thanks for taking our questions.

Speaker #1: Thank you.

Speaker #2: I'm now showing no further questions at this time. I would now like to turn it back to Liz for closing remarks.

Speaker #1: All right. I just want to say thank you, everybody, for those of you who have hung in there for us with us for several years.

Speaker #1: It's nice to be in the place that we're in right now. As I mentioned earlier, we're just scratching the surface. The opportunity for this story and John Mito to continue to grow and then for our company in the long term, given the pipeline and kind of where we're headed, our long-term strategic outlook, very, very positive.

Speaker #1: And we're very excited about it and appreciate all the support we'll continue to provide updates as we go along. So thanks, everybody, for joining this morning.

Speaker #1: Take care. You can now disconnect, operator.