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Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 10:00 a.m. ET Senior Director of Investor Relations - Vincent Perrone President and Chief Executive Officer - Elizabeth Barrett Chief Medical Officer - Mark Schoenberg Chief Financial Officer - Christopher Degnan Operator: Good day, and thank you for standing by. Welcome to the UroGen Pharma's Q2 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of Investor Relations. Please go ahead. Vincent Perrone: 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. 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, among other things, statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, ongoing and planned clinical and nonclinical trials, 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, the potential benefits of our products and product candidates and all future R&D efforts and milestones, our corporate goals and 2026 financial guidance. 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? Elizabeth Barrett: 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 ZUSDURI launch and meaningful progress advancing our long-term growth strategy. ZUSDURI generated $50.4 million 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. 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. That progress reflects the compelling value proposition of ZUSDURI. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, ZUSDURI offers patients a treatment that provides unprecedented recurrence and treatment-free intervals. ZUSDURI is a primary nonsurgical option for a disease that historically 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 ZUSDURI as a foundational treatment in this setting. As with 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. As of June 30, 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. Importantly, repeat prescribers now represent approximately 45% of writers 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. It demonstrates that physicians are gaining confidence through real-world experience and increasingly incorporating ZUSDURI into routine clinical practice. Equally encouraging, these trends remain consistent throughout the quarter, 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. 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. 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 JELMYTO, 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. 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. 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. 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. Our priorities remain clear: expanding community adoption, increasing repeat utilization, continued improvement of patient conversion and increasing awareness among both physicians and patients. We are beginning to invest more directly in patient awareness. Many patients with recurrent low-grade IR non-muscle invasive bladder cancer are not aware that a nonsurgical treatment option exists, and we believe increasing that awareness represents an important opportunity to expand utilization in the mid- to long term. Turning to JELMYTO. Revenue was $22 million in the second quarter compared to $21.7 million in the first quarter. JELMYTO continues to demonstrate a stable and predictable demand profile while also continuing to add new users. We believe we're on track to deliver within our full year revenue guidance of $97 million to $101 million. During the quarter, we continued to strengthen the long-term foundation of our uro-oncology portfolio. We reached a settlement and license agreement with Teva that resolved the JELMYTO patent litigation, providing greater visibility into the product's long-term commercial runway while reinforcing the strength of our RTGel intellectual property portfolio. 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 ZUSDURI and UGN-103. This patent, once issued, is expected to provide protection into July of 2044, strengthening the intellectual property supporting the franchise and reinforcing the long-term commercial opportunity for both products. We continue to make meaningful progress across our pipeline. UGN-103 remains on track for NDA submission in the next few weeks. UGN-104 continues progress through Phase III and following FDA acceptance of our IND, we're excited to begin Phase I development of UGN-501 this year. Overall, the first half of 2026 has significantly strengthened our conviction in the long-term opportunity ahead. We are successfully scaling the ZUSDURI launch, advancing multiple pipeline programs and building a company positioned for sustained growth. 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. Mark? Mark Schoenberg: Thank you, Lance, and good morning, everyone. Let me begin with the most recent update from the Phase III ENVISION trial. In May, we announced updated durability data from ENVISION with nearly 3 years of follow-up. 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. The most important takeaway is that the complete response obtained with ZUSDURI is highly durable through 3 years and was achieved without any maintenance therapy. 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 ZUSDURI's potential to interrupt that cycle. 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 ZUSDURI. 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 ZUSDURI administration as easy to integrate into routine neurology practice without meaningful disruption to existing workflows. Second, as physicians gain experience, they are becoming increasingly confident in expanding use beyond their initial patients. Rather than reserving ZUSDURI 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. And finally, the panel also discussed how they expect ZUSDURI 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. We believe these characteristics position ZUSDURI favorably as the treatment landscape continues to evolve. The event also included a patient perspective, one that reinforced what we heard from physicians. She described the burden of repeated recurrences in multiple TURBT procedures before she received ZUSDURI, as well as the impact that achieving a durable complete response had on allowing her to return to her normal life. We believe it reflects the experiences of many patients now being treated with ZUSDURI, and it's a reminder of why we think the opportunity here is so meaningful. 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 ZUSDURI in clinical practice today, we remain equally focused on extending the leadership through our next-generation pipeline. 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. As we announced previously, the Phase III 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 ZUSDURI in the pivotal ENVISION trial. 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. Looking beyond the initial indication, we continue to expand the long-term opportunity for UGN-103. Following a productive Type C meeting with the FDA, we plan to initiate a Phase III trial later this year to evaluate UGN-103 in high-grade NMIBC and in the adjuvant setting for newly diagnosed patients with low-grade intermediate risk disease, which remains on track for 2027. Our Phase III 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. UGN-501 is our investigational next-generation oncolytic virus being developed for high-grade NMIBC. In July, the FDA cleared our IND, and we expect to initiate a Phase I trial later this year. What continues to excite us about this program is its differentiated biology. UGN-501 is engineered to combine a direct tumor cell destruction with a subsequent immunomodulatory effect, providing what we believe is a unique mechanism among oncolytic viruses currently in development. Our nonclinical 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. The Phase I trial will initially evaluate intravesical administration, while future development will explore delivery using our RTGel technology to potentially extend dwell time and enhance local activity. And with that, I'll turn the call over to Chris to review our financial results. Chris? Christopher Degnan: 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. This increase was driven by the continued commercial launch of ZUSDURI. 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. The decrease in R&D expenses was primarily attributable to ZUSDURI manufacturing costs, which were recognized as an R&D expense in the second quarter of 2025 prior to receiving FDA approval. 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 ZUSDURI commercial activities, including sales force expansion following ZUSDURI approval and higher brand marketing expenses and an increase in overall commercial operation costs. 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 second quarter of 2025. Interest expense on our long-term debt was $4.9 million compared with $4.1 million in the same period last year. We reported a net loss of $14.4 million or $0.28 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. As of June 30, 2026, we had $108 million in cash, cash equivalents and marketable securities. Turning to guidance. We continue to expect JELMYTO net product revenue of $97 million to $101 million for 2026, which represents growth of roughly 3% to 7% over 2025. As we have noted prior, we are not issuing full year ZUSDURI guidance while the launch is still in its early stages. We are increasing our full year operating expense guidance to $260 million to $270 million, including approximately $20 million to $24 million of noncash share-based compensation expense. This increase reflects our decision to accelerate investment behind the business in response to the continued strength of the ZUSDURI launch. Specifically, we plan to increase investment in ZUSDURI, health care professional, promotional education and patient awareness initiatives to support long-term commercial adoption and also accelerate start-up activities for the UGN-103 high-grade trial and development activities to explore UGN-501 with our RTGel technology. 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 to reach profitability with our existing capital resources. That concludes our remarks. We will now open the call to questions. Operator: Our first question comes from the line of Raghuram Selvaraju of H.C. Wainwright & Company. Raghuram Selvaraju: 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 ZUSDURI at the community hospital setting, how ZUSDURI might potentially be viewed as a privileged product, an 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 ZUSDURI at the academic center level? Elizabeth Barrett: Raj, (sic) [ Ram ] it's Liz. 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 hospitals? Raghuram Selvaraju: Sorry, community practices. Community practices, yes. Elizabeth Barrett: Okay, yes. [ Fair enough. ] So look, at the end of the day, what we've said in the remarks is that about -- we know that most patients, whether it's around 70% of patients are actually seen in the community setting. So getting to the community setting is obviously very key for us. You have your LUGPAs, your large group practices. We also have a lot of practices that have now been consolidated under a lot of the PEs. But for the most part, they all work independently. They operate really independently. So that -- 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. 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 "service line" that they call it is great for them to attract patients. 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. So they want to be at the forefront of medicine. They want to be at the forefront. They want to be doing these things. It's much easier for them to operationalize because they're not having to deal with the pharmacy deals with most of it. 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. 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. I mean, we hear a lot about inflection. But the reality of it is we've talked about this before, urology is little slow. They're slow compared to oncologists. So even though we had a great quarter, we're real thrilled with where we are, there's still so much opportunity out there for us to accelerate growth. 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. Raghuram Selvaraju: No, that's very helpful. And then just very quickly, I was wondering when you believe you might be in a position to provide ZUSDURI revenue guidance, if you're thinking about doing that before the year closes, or failing that possibly to start off 2027? Also, I wanted to see if you felt you had a handle at this point on the timing of release of the Phase III trial of UGN-104. And this is something that I've asked before, if you're seeing with the added momentum behind ZUSDURI, any meaningful sort of spillover positive impact on JELMYTO uptake at this time? Christopher Degnan: Just on the guidance front, Ram, thanks for the question. We're pleased with the progress, obviously, 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 ZUSDURI. So I would think more for next year in terms of ZUSDURI guidance. Elizabeth Barrett: The 104? (sic) [ UGN-104 ] Christopher Degnan: Yes. 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 of the 103 (sic) [ UGN-103 ] initiative, but we're very bullish on the uptake of that as well as the success of molecule to JELMYTO. Elizabeth Barrett: Yes. And look, to answer your question, no, we have not seen the -- what I call a reverse halo on JELMYTO. We've sort of -- you can look at it both ways. On one side, the priority, frankly, for the sales team and our -- they are incentivized that ZUSDURI is the priority. And we made that decision. We believe that's the right decision. Having said that, obviously, we want to continue to drive JELMYTO revenue, but also give patients the opportunity. So we are seeing -- I would say that we are seeing some new doctors use JELMYTO that had not used JELMYTO when we go to talk to them initially about ZUSDURI. 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? Yes, absolutely. By going to more doctors, what we are seeing this year is we are seeing a lot of clinical trials. As you guys know, there's a lot of competitors coming into the space, and they're really focused on enrolling in the U.S. 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 JELMYTO patients. So it's kind of hard to tell at this point, but we don't believe that we've seen this reverse halo. Operator: Our next question comes from the line of Tara Bancroft of TD Cowen. Tara Bancroft: 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. So I'm curious to hear in what metric or factor particularly drove that acceleration in 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, maybe continued acceleration, linear or something else? And yes. Elizabeth Barrett: Great. Thanks, Tara. I'm going to ask Chris to comment and then I'll add any commentary. Christopher Degnan: Thanks, Tara. Sure. As Liz mentioned in the prior question, urologists tend to be slower to adopt and they will try it on 1 or 2 patients and then expand to other patients. 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. I mean one thing we're watching is potential summer seasonality as an example. But nothing specific, Tara, in terms of what's driving kind of the slightly faster than linear growth within Q2. 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. Elizabeth Barrett: Yes. And I think we just want to be a little bit cautious on Q3. We do expect growth. And yes, we're expecting we'll continue that quarter-over-quarter growth. 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. 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. So I 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. Operator: Our next question comes from the line of Kelsey Goodwin of Piper Sandler. Kelsey Goodwin: Congrats on a really great quarter. That's awesome. Two ones from us. Yes, yes, of course. Congrats again. Two ones from us. The first one, based on your channel checks, after how many TURBT are patients getting ZUSDURI now? And do you have a sense for what the split is among ZUSDURI users that are eligible versus ineligible for surgery? 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 ZUSDURI in the adjuvant setting. 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? Elizabeth Barrett: Yes. 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? 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 1, after 2, after 3, after 5, after 40, believe it or not, TURBTs. So we are seeing it across the board. So we are not seeing physicians only treat patients that are ineligible for surgery. Mark is probably going to tell you, no one is really ineligible for surgery at the end of the day. Mark Schoenberg: That is what I'm going to tell you. Almost nobody. Elizabeth Barrett: Right. So there's this -- would rather not put them under general anesthesia. So I would say a very small portion of them are "Just ineligible patients." But you do have a large portion of them, I would -- but less than 50% are what we would call prefer comorbidities, prefer not to put them through surgery. 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, 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 are seeing more and more of them using it in without surgery, which we think is great. 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 our patients because patients don't want to go through surgery. 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. 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. 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. So hopefully, that's helpful. Kelsey Goodwin: Yes, that's great. And maybe just to slip 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 to and through profitability at this point? And that's it for me. Christopher Degnan: Good question, Kelsey. And the answer is yes, we are still confident in that our capital resources will get us to and through profitability. Elizabeth Barrett: Yes. 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. 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 saw the revenue coming in. So to Chris' 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. Operator: Our next question comes from the line of Leland Gershell of Oppenheimer. Leland Gershell: Let me also add my congratulations on the ZUSDURI number. It certainly makes sense to be further in support for this key growth driver. A couple of questions. I wanted to ask, Liz, in the past, I think you've said that you see $1 billion or maybe over $1 billion in total revenue for UroGen by the end of the decade. I'm wondering if there's any contemplation of potentially revising that number upward given the strong sales trajectory? And also wanted to ask, this is sort of an out -- further out question, but when you make the transition in the marketplace from ZUSDURI to 103, and I guess the same would apply for JELMYTO-104. (sic) [ JELMYTO to UGN-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. Just wanted to ask about that. Elizabeth Barrett: Yes, 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 -- and we've said $1 billion plus only on ZUSDURI. 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. 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. And what we've said all along is that 20% market share for ZUSDURI is a $1.2 billion market. Do we believe there's opportunity to do significantly more than that? Yes, sure, there is. Absolutely. But what we've committed to is that it's a $1 billion-plus market product with just ZUSDURI alone. As we -- the switch, I think the great news with the patent extension is something we've been working on for a long time, kudos to our legal team here. And to get that additional patent on ZUSDURI, I think, gives us a lot of flexibility as we transition ZUSDURI to UGN-103 and JELMYTO to 104 and obviously, not in the same situation. So just talking about ZUSDURI, 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. There'll be a time period when they're both on the market -- but UGN-103 has a lot of benefits from a production standpoint of manufacturing, ensuring supply, extended dating on the drug. 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. And the same thing with JELMYTO 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, 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 ZUSDURI and give us freedom to operate through 2044. So whether it's ZUSDURI or UGN-103, we're in it for the long haul. So I hope that helps, Leland. Operator: Our next question comes from the line of Amin Makarem of Jefferies. Mohamad Amin Makarem: 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? And how many eligible patients do you expect to have within this 1,400 activated sites? Christopher Degnan: Yes. 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 ZUSDURI. So they're through the credit checks on board with our 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. 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. And so again, we feel good about the number of sites that we have ready to go. But really from a focus perspective, I would be pointing to the HCP adoption rate. Operator: Our next question comes from the line of Michael Schmidt of Guggenheim. Michael Schmidt: I had a pipeline question around UGN-103. So with the planned Phase III study in high-risk NMIBC 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? And how is UGN-103 positioned in the high-risk category relative to other available and emerging therapies? Thanks very much. Mark Schoenberg: It's Mark. 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 TURBT plus intravesical chemotherapy. 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. 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 RTGel platform will be obvious 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, 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. [indiscernible] Michael Schmidt: What is the size of that? Opportunity size? Mark Schoenberg: What are we saying about the size of the size of the opportunity? Elizabeth Barrett: The size of the papillary. I mean, look, within high-grade, obviously, there's a lot of different patient segmentations and populations. Everybody has talked about it being a multibillion dollar market, and it's a big portion -- percentage of that. It's actually the majority of the patients, right? The majority of patients don't have -- are in this papillary area. But -- so the reality of this is a lot of opportunity. From a competitive standpoint, we often talk about it being 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. When you look at it in comparison and who's actually -- what the data looks like, we think there's a real opportunity for us with UGN-103 to not only at least be as good or better than the incoming -- the players that are there now, we believe we can be. 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. 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 radical cystectomy and therefore, are going to cycle through multiple therapies. And what we're hearing, still there's a lot of opportunity for these patients to cycle through. 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 6 weeks, but you're getting maintenance therapy as well. 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. So from a pure business opportunity, it's there. But from a patient opportunity, absolutely, these patients need more options. Operator: Our next question comes from the line of Paul Choi of Goldman Sachs. Unknown Analyst: This is [ Eric ] on for Paul Choi. I just wanted to elaborate a little bit more on the sequencing of adjuvant therapies here. As you were mentioning in the previous answer, as competitive oncolytic immunotherapies begin establishing adjuvant treatment roles in the intermediate risk segment, how do you expect your urologists to sequence ZUSDURI upon recurrence? Do you think they will bypass adjuvant treatments entirely in favor of ZUSDURI? Or what do you -- how do you perceive the treatment algorithm evolving? Mark Schoenberg: 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. The panelists, and I shared their opinion, believe that now that ZUSDURI is available, the likely sequence of events will be the following. Patients will come in for an initial presentation with tumor and undergo a TURBT, which will provide a diagnosis and staging. 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 exceedingly high likelihood of recurrence subsequently if they are treated using the standard of care, i.e., TURBT. And so the panelists believe that what will happen upon recurrence increasingly as physicians become more familiar with ZUSDURI is that ZUSDURI will become the default next therapy when a patient fails or recurs following TURBT. If a patient develops a long-term disease-free interval following ZUSDURI, there's no reason to believe upon recurrence, again, should one occur that the patient couldn't be retreated with ZUSDURI, although we don't have information about that yet, though it's likely to emerge as we track this practice as it evolves. But if patients demonstrate a refractory response to ZUSDURI, 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 TURBT and then have some other agent introduced intravesically. But ZUSDURI looks like it's going to emerge as the next thing to do when the patient recurs after the first TURBT. Elizabeth Barrett: Yes. 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, 6 weeks and you're done, right? 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'd like to challenge anyone to meet or beat those -- that type of data out in the marketplace. Operator: Our next question comes from the line of Kevin DeGeeter of Ladenburg Thalmann. Kevin DeGeeter: I just have one on 501. (sic) [ UGN-501 ] Can you just walk me through the thinking on how to characterize in addition to the safety profile kind of go, no-go from the Phase I? Is it -- should I think about replication sort of within the cells being interesting in going forward efficacy parameter. Just how do I think about the most relevant learning from Phase I? And I guess related, is there an opportunity for a meaningful update in 2027? Mark Schoenberg: Thanks for the question. So we're excited about 501 in large part because of its differentiated biology. It is an interesting oncolytic virus specifically engineered to act initially like a chemotherapy. So it will be highly cytolytic initially, and that will then lead to a secondary immune response. We have a lot of preclinical and in additional clinical data to suggest that 501 is going to be very active. And our preclinical data, in particular, in bladder cancer cell lines suggest that it is very active against a wide variety of urothelial cancers in vitro. So we're expecting it to be active in humans as well. As you know, as everybody knows, Phase I studies are primarily focused on safety and tolerability, not efficacy, 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 II looks like. 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. Elizabeth Barrett: 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. Operator: I'm now showing no further questions at this time. I would now like to turn it back to Liz for closing remarks. Elizabeth Barrett: 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, 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 ZUSDURI and JELMYTO to continue to grow and then for our company in the long term, given our pipeline and kind of where we're headed, our long-term strategic outlook, very, very positive, 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. Take care. You can now disconnect, operator. Operator: Okay. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in UroGen Pharma, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and UroGen Pharma wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. UroGen (URGN) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. UroGen Pharma (URGN) is back on investors radar after reporting second quarter 2026 results on 5 August, highlighted by higher reported sales and a smaller net loss for both the quarter and first half. The company reported Q2 sales of US$72.46 million with a net loss of US$14.35 million, and first half sales of US$123.42 million with a net loss of US$37.93 million, which may be reshaping sentiment around the stock. See our latest analysis for UroGen Pharma. The strong Q2 report on 5 August appears to have fed into existing momentum in UroGen Pharma, with a 7 day share price return of 22.80% and a year to date share price return of 106.78%. The 1 year total shareholder return of 164.64% points to improving sentiment over a longer period. If you are looking for more healthcare related ideas after UroGen Pharma's latest move, it may be worth scanning other opportunities through our healthcare focused AI stock screener at 43 healthcare AI stocks After UroGen Pharma's sharp run following Q2 2026, the key debate now is whether most of the easy gains are already captured or if the current valuation still leaves meaningful upside ahead. The most followed narrative puts UroGen Pharma's fair value at $36.11 a share, which sits below the latest close of $46.96 and frames the recent rally in a different light. Read the complete narrative. Want to see what sits behind that fair value gap? The narrative leans heavily on rapid top line growth, margin expansion and a re rated future earnings multiple. The current fair value view for UroGen Pharma uses a 7.34% discount rate and a detailed set of revenue, earnings and margin assumptions that run through to 2029. The narrative also factors in widening analyst forecasts and the possibility that profit growth and share issuance play out differently to the base case, which is why readers often focus on the underlying scenario work rather than the headline target alone. Result: Fair Value of $36.11 (OVERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, UroGen Pharma still carries risks, including ongoing reported net losses and concentrated revenue exposure, which could matter if product uptake or reimbursement progress stalls. Find out about the key risks to this UroGen Pharma narrative. The first narrative around UroGen Pharma points to a fair value of $36.11 and labels the stock as overvalued. Our DCF model tells a very different story. It places fair value at $355.54 a share, which implies the current $46.96 price sits far below that estimate. Which set of assumptions do you trust more? Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out UroGen Pharma for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 52 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. If this mix of optimism and caution around UroGen Pharma feels familiar, move quickly to review the details and test your own thesis. To weigh both sides of the argument in one place, start with the 2 key rewards and 2 important warning signs. If you want a broader watchlist alongside UroGen Pharma, now is the moment to hunt for fresh ideas using the Simply Wall Street Screener before the next wave of moves. Target companies that combine healthy cash generation with attractive prices by scanning through 52 high quality undervalued stocks. Prioritise stability by checking out 83 resilient stocks with low risk scores which focuses on businesses with more resilient profiles and lower overall risk scores. Spot potential future standouts early by running your filters through the screener containing 21 high quality undiscovered gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include URGN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

This article first appeared on GuruFocus. Total Revenue: $72.5 million in Q2 2026, compared with $24.2 million in Q2 2025. Jelmyto Revenue: $22.0 million in Q2 2026, compared with $21.7 million in Q1 2026. Research and Development Expenses: $17.3 million in Q2 2026, compared with $18.9 million in Q2 2025. Selling, General and Administrative Expenses: $48.4 million in Q2 2026, compared with $43.2 million in Q2 2025. Net Loss: $14.4 million, or $0.28 per basic and diluted share, in Q2 2026, compared with a net loss of $49.9 million, or $1.05 per share, in Q2 2025. Cash Position: $108 million in cash equivalents and marketable securities as of June 30, 2026. 2026 Jelmyto Revenue Guidance: Expected to be $97 million to $101 million. 2026 Operating Expense Guidance: Increased to $260 million to $270 million, including $20 million to $24 million of non-cash share-based compensation. Warning! GuruFocus has detected 10 Warning Signs with URGN. Is URGN fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. UroGen Pharma Ltd (NASDAQ:URGN) reported a strong second quarter with Cysview (UGN-102) net product revenue of $50.4 million, a 73% increase over the first quarter, driven by expanding adoption and repeat utilization. The company saw significant growth in its commercial metrics, with activated accounts increasing to 1,444, unique prescribers rising to 452, and repeat prescribers nearly doubling to 204, representing 45% of prescribers. UroGen Pharma Ltd (NASDAQ:URGN) is seeing successful expansion into community urology practices, which now account for approximately 55% of utilization, aligning with the estimated 70% of the addressable market in that setting. The company strengthened its long-term intellectual property position with a new method of treatment patent for Cysview and UGN-103, expected to provide protection into July 2044, and a settlement with Teva resolving GelMito patent litigation. UroGen Pharma Ltd (NASDAQ:URGN) is making significant pipeline progress, with UGN-103 on track for NDA submission in Q3 2026, UGN-104 on track to complete enrollment by end of 2026, and UGN-501 receiving FDA IND clearance to begin Phase 1 development. The company reported a significantly reduced net loss of $14.4 million in Q2 2026, compared to a net loss of $49.9 million in the same period last year, and remains confident in reaching profitability with existing capital resources. UroGen Pharma Ltd (NASDAQ:URGN) is not issuing full-year revenue guidance for Cysview, citing the launch is still in its early stages, which may create uncertainty for investors. The company increased its full-year operating expense guidance to $260 million to $270 million, reflecting accelerated investment in promotional activities and pipeline development, which could pressure near-term profitability. UroGen Pharma Ltd (NASDAQ:URGN) expects only linear growth for Cysview in the near term, with management cautioning against expecting acceleration in Q3 due to potential summer seasonality and the slow adoption rate of urologists. The company has not observed a 'reverse halo' effect on Jelmyto from the Cysview launch, and notes that clinical trials for both its own UGN-104 and competitor studies are potentially taking patients who would have been Jelmyto users. UroGen Pharma Ltd (NASDAQ:URGN) faces a competitive landscape in the high-grade NMIBC space for UGN-103, with multiple emerging therapies, though management believes its product's profile offers advantages. The company's path to profitability is dependent on the continued success of the Cysview launch, and any slowdown in adoption or increased competition could impact its ability to achieve this goal with its current capital resources. Q: Can you provide additional color on the demand level for Zystori in community practices versus academic centers, and how the community setting compares in terms of market size opportunity? A: Liz Barrett (CEO) explained that approximately 70% of patients are seen in community settings, making it a key growth driver. While academic centers see faster initial uptake due to easier operationalization, community practices represent the largest opportunity. She noted that large group practices, once fully integrated, will be the biggest driver of growth inflection, but adoption in this segment is still very early. Q: What metric or factor drove the acceleration in growth this quarter, and how should we think about growth for the rest of the year? A: Chris Degnan (CFO) attributed the stronger-than-linear growth to consistent expansion across all commercial metrics, including activated accounts, prescribers, and repeat utilization. He cautioned that quarter-to-quarter variability is expected, with potential summer seasonality, and reiterated that a linear growth profile remains the appropriate model. Liz Barrett added that while growth is expected to continue, they do not anticipate acceleration in Q3. Q: After how many TURBTs are patients receiving Zystori, and are physicians using it in the adjuvant setting or as a primary treatment? A: Liz Barrett (CEO) stated that usage spans across the board, from patients with one TURBT to those with over 40, indicating broad adoption. She noted that less than 50% of patients are considered "ineligible" for surgery, and as physicians gain experience, they are increasingly using Zystori as a primary treatment without prior surgery. The company is investing in patient awareness programs to further drive this trend. Q: Are you still comfortable with your cash position to reach profitability, and what are your updated thoughts on the $1 billion revenue target? A: Chris Degnan (CFO) confirmed that the company remains confident that existing capital resources will get them to and through profitability. Liz Barrett (CEO) reiterated the "1 billion plus" revenue target for Zystori alone, noting that a 20% market share equates to a $1.2 billion opportunity. She expressed confidence that the strong sales trajectory could potentially exceed this target, depending on physician adoption and timing. Q: How will the transition from Zystori to UGN-103 and from Jelmyto to UGN-104 be managed in the marketplace? A: Liz Barrett (CEO) explained that the company will wait for a J-code before transitioning, and there will be a period where both products are on the market. UGN-103 offers manufacturing and supply benefits, so the company will aim to switch as quickly as possible without jeopardizing adoption. The recent patent extension for Zystori through 2044 provides flexibility and long-term freedom to operate. Q: How do you think about the competitive landscape for UGN-103 in high-grade NMIBC, and what is the size of that opportunity? A: Mark Schoenberg (CMO) detailed that the Phase 3 study will focus on papillary disease in an adjuvant setting compared to TURBT plus intravesical chemotherapy. The value proposition is the extended dwell time of the RTGel platform, which should provide an advantage over aqueous chemotherapy. Liz Barrett added that high-grade NMIBC is a multibillion-dollar market, and UGN-103's safety profile and ease of use, combined with maintenance therapy pricing, position it favorably against competitors. Q: How do you expect urologists to sequence Zystori with other emerging adjuvant therapies upon recurrence? A: Mark Schoenberg (CMO) shared insights from a recent panel discussion, indicating that Zystori is expected to become the default next therapy upon recurrence after an initial TURBT. If patients achieve a long-term disease-free interval, retreatment with Zystori is possible. For refractory patients, other intravesical agents would be introduced. This sequencing reflects the strong durability data and the treatment-free interval benefit of Zystori. Q: What are the key learnings and go/no-go criteria for the Phase 1 trial of UGN-501, and can we expect meaningful data in 2027? A: Mark Schoenberg (CMO) explained that UGN-501 is a differentiated oncolytic virus engineered for initial cytolytic activity followed by an immunomodulatory effect. The Phase 1 trial will focus on safety and tolerability, but efficacy signals will be sought in high-grade NMIBC patients. Liz Barrett added that the company has high expectations and anticipates meaningful data in 2027. Q: With 1,444 activated sites and 452 prescribers, how quickly can you close the gap, and how many eligible patients are within these sites? A: Chris Degnan (CFO) clarified that site activation means operational readiness, including credit checks and specialty distributor onboarding. The focus should be on the HCP adoption rate and the linear growth trend of physicians coming online, rather than the gap between sites and prescribers. The company feels good about the number of ready sites and the ongoing conversion to utilization. Q: Have you seen any spillover positive impact on Jelmyto from the Zystori launch momentum? A: Liz Barrett (CEO) stated that they have not seen a "reverse halo" effect on Jelmyto. While some new doctors have started using Jelmyto after initial Zystori discussions, overall, the halo effect has not materialized. She noted that competing clinical trials, including their own UGN-104 study, are enrolling patients who might otherwise have been Jelmyto candidates, making it difficult to assess the full impact. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Urogen Pharma? Here are five stocks we like better. Revenue surged to $72.5 million in the second quarter, up from $24.2 million a year earlier, driven by ZUSDURI net product revenue of $50.4 million. The net loss narrowed to $14.4 million from $49.9 million. ZUSDURI adoption expanded significantly, with activated accounts rising to 1,444 and repeat prescribers nearly doubling to 204. Community practices accounted for about 55% of utilization, while management expects continued—but slower—quarter-over-quarter growth in the third quarter. UroGen advanced its pipeline, remaining on track to file UGN-103’s NDA in the third quarter and begin additional Phase 3 work later this year. The company raised 2026 operating-expense guidance to $260 million-$270 million as it increases commercial and development investments. 3 Bullish Biotech Stocks With Explosive Growth Trends Urogen Pharma (NASDAQ:URGN) reported second-quarter 2026 revenue of $72.5 million, up from $24.2 million a year earlier, as the commercial launch of bladder cancer treatment ZUSDURI continued to gain traction. The company recorded a net loss of $14.4 million, or $0.28 per share, compared with a $49.9 million loss, or $1.05 per share, in the prior-year quarter. ZUSDURI generated $50.4 million in net product revenue during the quarter, representing a 73% increase from the first quarter, according to President and Chief Executive Officer Liz Barrett. The treatment is approved for adults with recurrent, low-grade, intermediate-risk non-muscle invasive bladder cancer. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Barrett said the launch showed expanding use in hospital and community settings, greater repeat prescribing and improved practice workflows. As of June 30, the company had 1,444 activated accounts, compared with 972 at the end of the first quarter. Unique prescribers rose to 452 from 256, while repeat prescribers nearly doubled to 204. Repeat prescribers represented about 45% of ZUSDURI writers at quarter-end, versus approximately 40% in the first quarter. Barrett said the company considers repeat use an important measure of physicians’ confidence and the product’s potential for longer-term adoption. → 3 Drone Stocks That Should Soar After the Summer Slump Approximately 55% of ZUSDURI utilization came from community urology practices at the end of the quarter, compared with 45% from hospitals. Barrett said UroGen estimates that about 70% of the addressable market is treated in community practices, making that setting a key opportunity for future growth. The company said it has open access across more than 95% of covered lives and does not see material reimbursement barriers. Barrett said the product’s permanent J-code has improved reimbursement confidence and enabled broader utilization. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Management said it is working to reduce the time between patient enrollment and treatment initiation. UroGen’s goal is to reach a two-to-three-week enrollment-to-treatment cycle similar to what it sees for JELMYTO, its treatment for low-grade upper tract urothelial cancer. During the question-and-answer session, Barrett said ZUSDURI usage has been observed across patients who have undergone varying numbers of transurethral resection of bladder tumor, or TURBT, procedures. She said physicians are increasingly using the treatment without surgery as they gain familiarity with it, although some continue to use it after an initial procedure. Chief Financial Officer Chris Degnan said the company expects quarter-to-quarter variability in ZUSDURI sales, including possible seasonal effects during the summer. While management expects continued quarter-over-quarter growth in the third quarter, Barrett said the company does not expect the same degree of acceleration seen in the second quarter. UroGen does not yet provide full-year ZUSDURI revenue guidance. Degnan said the company intends to let demand trends develop through the remainder of 2026 before considering formal guidance, which he indicated would be more likely next year. JELMYTO generated $22 million in second-quarter revenue, compared with $21.7 million in the first quarter. UroGen maintained its full-year JELMYTO net product revenue guidance of $97 million to $101 million, representing growth of roughly 3% to 7% over 2025. Barrett said the company has seen some physicians begin using JELMYTO after being contacted about ZUSDURI, but it has not experienced a broad “halo” effect on JELMYTO demand. She also noted that UroGen’s sales force has prioritized ZUSDURI and that clinical trials, including UroGen’s UGN-104 study and competitor studies, may be enrolling patients who might otherwise have been candidates for JELMYTO. During the quarter, UroGen reached a settlement and license agreement with Teva that resolved JELMYTO patent litigation. The company also received a notice of allowance from the U.S. Patent and Trademark Office for a method-of-treatment patent covering ZUSDURI and UGN-103. UroGen expects the patent, once issued, to provide protection through July 2044. Chief Medical Officer Mark Schoenberg said updated data from the Phase 3 ENVISION study showed that, among patients who achieved a complete response at three months, the Kaplan-Meier estimated probability of remaining disease-free at 36 months was 64.5%. At a median follow-up of 35.5 months, the median duration of response had not been reached. UroGen remains on track to submit a new drug application for UGN-103, an investigational next-generation treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, in the third quarter of 2026. The company previously reported a six-month duration of response of 94.5% by Kaplan-Meier estimate in the Phase 3 UTOPIA trial. Following a Type C meeting with the FDA, UroGen plans to begin a Phase 3 trial of UGN-103 later this year in high-grade non-muscle invasive bladder cancer. The company also plans to study the treatment in the adjuvant setting for newly diagnosed low-grade intermediate-risk patients beginning in 2027. UGN-104, a potential successor to JELMYTO for low-grade upper tract urothelial cancer, remains in Phase 3 development, with enrollment expected to be completed by the end of 2026. UroGen also expects to begin a Phase 1 study of UGN-501, an investigational oncolytic virus for high-grade non-muscle invasive bladder cancer, later this year after the FDA cleared its investigational new drug application in July. Research and development expense fell to $17.3 million from $18.9 million a year earlier, primarily because ZUSDURI manufacturing costs had been recorded as research and development expense before its FDA approval in 2025. Selling, general and administrative expense increased to $48.4 million from $43.2 million, reflecting ZUSDURI sales-force expansion, marketing and other commercial operating costs. UroGen raised its 2026 operating expense guidance to $260 million to $270 million, including about $20 million to $24 million in non-cash share-based compensation. Degnan said the increase reflects accelerated investment in healthcare professional education and patient-awareness efforts for ZUSDURI, as well as startup work for the UGN-103 high-grade trial and development activities for UGN-501 using the company’s RTGel technology. As of June 30, UroGen had $108 million in cash, cash equivalents and marketable securities. Degnan said the company remains confident its existing capital resources can fund operations through profitability. UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for uro-oncology and uro-genital diseases. Founded in 2010 and headquartered in Ra'anana, Israel, with offices in New York, UroGen applies its proprietary RTGel® reverse thermal gel delivery platform to create sustained-release formulations designed for in-office use by urologists. The company's lead product, Jelmyto® (mitomycin gel), received U.S. Food and Drug Administration approval in 2020 for the treatment of adults with low-grade upper tract urothelial cancer. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Urogen Pharma Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

ZUSDURI® generated $50.4 million in revenue in the second quarter of 2026, representing 73% quarter-over-quarter growth Once issued, new U.S. patent is expected to provide protection into July 2044 for ZUSDURI and UGN-103 Continued advancement of pipeline, with UGN-103 on track for NDA submission in the third quarter of 2026 and UGN-501 expected to begin a Phase 1 trial in the fourth quarter of 2026 Conference call and webcast held today at 10:00 AM ET PRINCETON, N.J., Aug. 05, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the second quarter ended June 30, 2026, and provided an overview of recent developments. “The second quarter marked another important step in establishing ZUSDURI as a foundational therapy for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The continued increase in utilization, expanding adoption across community practices, and growing repeat use reinforce our confidence we are building a durable commercial franchise with blockbuster potential. During the quarter, we strengthened the long-term sustainability of the franchise through a new U.S. patent allowance that, once the patent is issued, is expected to provide intellectual property coverage for both ZUSDURI and UGN-103 into July 2044. We believe this meaningfully enhances the long-term commercial opportunity for both products and further reinforces the sustainability of the franchise. Combined with the life-cycle expansion of UGN-103 and initiation of clinical development for UGN-501, we believe we are exceptionally well positioned to build a durable growth company and create long-term shareholder value.” Q2 2026 and Recent Business Highlights: ZUSDURI (mitomycin) for intravesical solution: ZUSDURI achieved net product revenue of $50.4 million in the second quarter of 2026, representing 73% growth over the first quarter of 2026. As of June 30, 2026, UroGen reported: Updated results from the Phase 3 ENVISION trial of ZUSDURI showed a 36-month duration of response (DOR) of 64.5% (95% CI: 54.6, 72.8) by Kaplan-Meier estimate among patients who achieved a complete response (CR) at three months (79.6%). At a median follow-up of 35.5 months, the median DOR had not been reached. ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing treatment burden for patients. UroGen received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) without transurethral resection of bladder tumor (TURBT). Once issued, the patent is expected to provide protection into July 2044, further strengthening the intellectual property supporting ZUSDURI and UGN-103 and reinforcing the long-term commercial opportunity for both products. American Urological Association (AUA) Key Opinion Leader Webinar: On May 17, 2026, UroGen hosted a Key Opinion Leader webinar at the AUA Annual Meeting in Washington, D.C., focused on real-world experience with ZUSDURI. The discussion highlighted patient selection, workflow integration, treatment patterns, and physician experience across both hospital and community practices, reinforcing growing confidence in the use of ZUSDURI in routine clinical practice. A replay of the event is accessible through the Investors section of the Company’s website. JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC: Generated net product revenue of $22.0 million in the quarter ended June 30, 2026, compared with $24.2 million reported for the second quarter of 2025. The Company continues to add new users and remains on track to deliver within its JELMYTO full-year 2026 guidance range of $97 million to $101 million. UroGen entered into a settlement and license agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc. (collectively, “Teva”) that resolves the patent litigation UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application to the U.S. FDA for a generic version of JELMYTO prior to the expiration of the relevant UroGen patents. Under the terms of the agreement, UroGen granted Teva a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. Next-generation novel mitomycin-based formulations for urothelial cancer: UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) DOR at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial in patients with LG-IR-NMIBC. The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR by Kaplan-Meier estimate observed with ZUSDURI in the pivotal ENVISION trial. UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026, with potential FDA approval in 2027 and full launch anticipated following receipt of a unique J-Code. UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI. The benefits of UGN-103 include a more streamlined manufacturing process and simplified reconstitution, while preserving the innovative and proven RTGel® technology that enables sustained drug exposure at tumor sites in the bladder. The Company expects to initiate a randomized controlled Phase 3 trial evaluating UGN-103 in high-risk NMIBC in the second half of 2026, and a trial evaluating UGN-103 as adjuvant therapy in newly diagnosed intermediate-risk NMIBC patients in 2027. The Phase 3 clinical trial evaluating UGN-104 in low-grade upper tract urothelial cancer (LG-UTUC) remains on track to complete enrollment by the end of 2026. UGN-501 (investigational next-generation oncolytic virus) for use in high-grade non-muscle invasive bladder cancer: UroGen’s Investigational New Drug application for UGN-501 has been accepted by the FDA, and the Company plans to initiate its Phase 1 clinical trial in NMIBC in the fourth quarter of 2026. Second Quarter 2026 Financial Results Revenue: Total revenue was $72.5 million in the second quarter of 2026, compared with $24.2 million in the second quarter of 2025. The increase was driven by the continued commercial launch of ZUSDURI. Research and Development (R&D) Expenses: R&D expenses were $17.3 million in the second quarter of 2026, including non-cash share-based compensation expense of $0.9 million. This compares to $18.9 million, including non-cash share-based compensation expense of $0.4 million, in the same period in 2025. The decrease in R&D expenses was primarily attributable to ZUSDURI manufacturing costs, which were recognized as an R&D expense in the second quarter of 2025 prior to receiving FDA approval. Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $48.4 million in the second quarter of 2026, including non-cash share-based compensation expense of $4.4 million. This compares to $43.2 million, including non-cash share-based compensation expense of $2.3 million, in the same period in 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, and an increase in overall commercial operation costs. Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.5 million in the second quarter of 2026, compared with $4.6 million in the same period in 2025. Interest Expense on Long-term Debt: Interest expense related to long-term debt was $4.9 million in the second quarter of 2026, compared with $4.1 million in the same period in 2025. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by the lower interest rate. Net Loss: UroGen reported a net loss of $14.4 million, or $0.28 per basic and diluted share, in the quarter ended June 30, 2026, compared with a net loss of $49.9 million, or ($1.05) per basic and diluted share, in the second quarter of 2025. Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, cash, cash equivalents and marketable securities totaled $108.0 million. 2026 JELMYTO Revenue and Updated Company Operating Expense Guidance: The Company continues to expect 2026 net product revenue for JELMYTO to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over the $94 million of JELMYTO revenue reported in 2025. The Company is not providing full-year 2026 revenue guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. The Company is increasing its full-year 2026 operating expenses guidance to be in the range of $260 million to $270 million, including non-cash share-based compensation expense of $20 million to $24 million. The increase reflects the decision to accelerate investment behind the business in response to the continued strength of the ZUSDURI launch. Specifically, the Company plans to increase investment in ZUSDURI peer-to-peer promotional education and patient awareness initiatives to support long-term commercial adoption, and also accelerate start-up activities for the UGN-103 high-grade NMIBC trial and development activities of UGN-501 with RTGel®. Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update. The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. About ZUSDURI ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. APPROVED USE FOR ZUSDURI ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove a tumor that did not work or is no longer working. IMPORTANT SAFETY INFORMATION You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI. Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems. are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose. How will I receive ZUSDURI? You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines. After receiving ZUSDURI: ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours. To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436. Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information. About JELMYTO JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemo-ablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow. APPROVED USE FOR JELMYTO JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC). IMPORTANT SAFETY INFORMATION You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract. Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose. Tell your healthcare provider if you take water pills (diuretic).How will I receive JELMYTO? Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment. You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses. JELMYTO is given to your kidney through a tube called a catheter. During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.After receiving JELMYTO: JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours. To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. JELMYTO may cause serious side effects, including: Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO. Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO. The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436. Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information. About UroGen Pharma Ltd. UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first product to treat LG-UTUC and second product (mitomycin) for intravesical solution for patients with recurrent LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X, @UroGenPharma. Forward-Looking Statements This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits and expected length of patent protection for ZUSDURI and UGN-103; UroGen’s planned and ongoing clinical trials and non-clinical studies and the timing for regulatory submissions and potential regulatory approvals for its product candidates, including UGN-103, UGN-104, and UGN-501; the belief in the significant commercial opportunity ahead and UroGen’s ability to fully capitalize on it; 2026 JELMYTO revenue and company operating expense guidance; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “anticipate,” “believe,” “can,” “continue,” “estimate,” “expect,” “may,” “on track,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; risks related to UroGen’s and its licensors’ ability to protect their respective patents and other intellectual property, including that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; the data from the UTOPIA trial may not be sufficient to support approval of UGN-103; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 6, 2026, as well as in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q being filed with the SEC later today, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release. INVESTOR CONTACT:Vincent PerroneSenior Director, Investor [email protected] ext. 1093 MEDIA CONTACT:Cindy RomanoDirector, Corporate [email protected] ext. 1083 Source: UroGen Pharma Ltd.

Insmed (INSM) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report, which is expected to be released on August 6, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biopharmaceutical developing inhaled treatments for patients battling rare lung diseases is expected to post quarterly loss of $0.69 per share in its upcoming report, which represents a year-over-year change of +59.4%. Revenues are expected to be $389.72 million, up 262.8% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 4.8% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Insmed, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +22.32%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Insmed will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Insmed would post a loss of$0.9 per share when it actually produced a loss of -$0.76, delivering a surprise of +15.56%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Insmed appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Urogen Pharma (URGN), is soon expected to post loss of $0.38 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +63.8%. Revenues for the quarter are expected to be $62.24 million, up 157% from the year-ago quarter. The consensus EPS estimate for Urogen Pharma has been revised 53.8% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +30.97%. This Earnings ESP, combined with its Zacks Rank #2 (Buy), suggests that Urogen Pharma will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Insmed, Inc. (INSM) : Free Stock Analysis Report Urogen Pharma (URGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

UroGen Pharma (URGN) has surged nearly 180% over the past year and has strong technical momentum. URGN maintains a 100% “Buy” technical opinion from Barchart. The company’s revenue is projected to more than double this year and grow by 56% next year. Earnings are estimated to rise by 75% and 263%, respectively. Despite five years of revenue growth, URGN remains unprofitable, and short interest stands at 12.76% of float with 9.42 days to cover. Valued at $1.94 billion, UroGen Pharma (URGN) is a clinical-stage biopharmaceutical company. It focuses on developing urological pathologies with a focus on uro-oncology. I found today’s Chart of the Day by using Barchart’s powerful screening functions to sort for stocks with the highest technical buy signals; superior current momentum in both strength and direction, Weighted Alpha above 50+ and a 60-Month Beta over 1.5. I then used Barchart’s Flipcharts feature to review the charts for consistent price appreciation. URGN checks those boxes. The Trend Seeker issued a new “Buy” signal on April 10. Since then, the stock has gained 85.54%. Micron Stock Is Off 31% From Its High. Why This Could Be the Best Time to Buy. Michael Saylor’s Bitcoin Treasury Company Strategy Is Falling Apart This Red-Hot AI Infrastructure Stock Just Made a Game-Changing Move. How to Play NBIS Here. Our exclusive Barchart Brief newsletter is your FREE midday guide to what's moving stocks, sectors, and investor sentiment - delivered right when you need the info most. Subscribe today! Editor’s Note: The technical indicators below are updated live during the session every 20 minutes and can therefore change each day as the market fluctuates. The indicator numbers shown below therefore may not match what you see live on the Barchart.com website when you read this report. These technical indicators form the Barchart Opinion on a particular stock. UroGen Pharma scored an all-time high of $41.36 on July 16. UroGen Pharma has a Weighted Alpha of 159.65. URGN has a 100% “Buy” opinion from Barchart. The stock has gained 178.94% over the past 52 weeks. UroGen Pharma has its Trend Seeker “Buy” signal intact. The stock recently traded at $40 with a 50-day moving average of $31.97. URGN has made 13 new highs and gained 25.20% over the past month. 60-month beta of 1.56. Relative Strength Index (RSI) is at 71.88. There’s a technical support level around $39.24. $1.94 billion market capitalization. Revenue is projected to grow 147.80% this year and another 56.03% next year. Earnings are estimated to increase 75.08% this year and an additional 263.68% next year. The Wall Street analysts followed by Barchart give the stock 7 “Strong Buy” and 2 “Hold” opinions with price targets between $18 and $45. Value Line rates the stock “Average.” CFRA’s MarketScope rates the stock a “Hold.” Morningstar thinks the stock is fairly valued. 3,530 investors are following the stock on Seeking Alpha, which rates it a “Strong Buy.” Short interest is 12.76% of the float with 9.42 days to cover the float. The company has had increases in revenue for the last 5 years but still hasn’t broken even. Analysts are predicting increases in both revenue and earnings this year and the next. However, short sellers are betting against the company. Additional disclosure: The Barchart Chart of the Day highlights stocks that are experiencing exceptional current price appreciation. They are not intended to be buy recommendations as these stocks are extremely volatile and speculative. Should you decide to add one of these stocks to your investment portfolio it is highly suggested you follow a predetermined diversification and moving stop loss discipline that is consistent with your personal investment risk tolerance. On the date of publication, Jim Van Meerten did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Barchart.com

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. UroGen Pharma (URGN) drew investor attention after Q1 2026 results showed revenue of US$50.96 million, a narrower net loss of US$23.57 million, and earnings and sales ahead of analyst estimates. See our latest analysis for UroGen Pharma. The Q1 beat and Zusduri momentum appear to have contributed to the recent share price performance, with a 47.48% 1‑month share price return and a very large 1‑year total shareholder return, suggesting sentiment has strengthened over both shorter and longer horizons. If UroGen’s move has you looking beyond a single biotech, this may be a good moment to hunt for other healthcare stocks riding similar trends with our 35 healthcare AI stocks With URGN up sharply over the past month, a value score of 5, and the stock trading roughly 32% below the average analyst price target, an important question arises: is there still upside here, or has the market already priced in future growth? At a last close of $26.59 against a narrative fair value of $36.11, UroGen is framed as materially undervalued, with that view pinned to ambitious growth and margin assumptions. Read the complete narrative. Want to see what earnings profile sits behind that valuation gap? Revenue scaling, margin reset and a different future multiple all sit at the core of this narrative. Result: Fair Value of $36.11 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the story also hinges on risks such as UroGen’s heavy operating losses and concentrated product base, which could pressure funding options and sentiment if execution slips. Find out about the key risks to this UroGen Pharma narrative. With sentiment clearly split between concern over risks and optimism about rewards, it makes sense to move quickly and weigh the data yourself using our 3 key rewards and 2 important warning signs If URGN has sparked your interest, do not stop here. Use the screener to find other stocks that could fit your style before the crowd moves on. Target potential mispricings by scanning 51 high quality undervalued stocks that pair quality fundamentals with prices that may not fully reflect them yet. Strengthen your income focus by reviewing 12 dividend fortresses designed for investors who want higher yields alongside resilience. Reduce portfolio stress by checking 72 resilient stocks with low risk scores built around companies with lower risk scores and steadier profiles. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include URGN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Image source: The Motley Fool. Wednesday, May 6, 2026 at 10 a.m. ET Chief Executive Officer — Elizabeth Barrett Chief Medical Officer — Mark Schoenberg Chief Financial Officer — Christopher Degnan Elizabeth Barrett: Thanks, Vincent. Good morning, and thank you for joining us today. Before I provide our business update, I wanted to share that given the critical importance of a successful ZUSDURI launch, the Board and I made the decision a few months ago that I would assume direct oversight of the commercial organization, resulting in the departure of David Lin. For the past several months, I have engaged directly with our commercial team and key external stakeholders, and this change has enhanced our ability to remain agile, promote efficient decision-making and leverage the expertise of our executive team. Now turning to our results. We are very pleased by our performance in the first quarter, highlighted by $29.2 million in ZUSDURI revenue. This represents more than 100% quarter-over-quarter growth. As expected, the implementation of the permanent J-code in January marked a major inflection point, and we are now seeing clear acceleration across key commercial metrics. The early momentum we discussed in the initial phase of the launch is now translating into expanded utilization and meaningful growth. Overall, the trends we are seeing are in line with our expectations and provide early validation of our commercial model. This progress reflects the differentiated value ZUSDURI brings to patients and physicians. As the first and only FDA-approved medicine for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, ZUSDURI offers a nonsurgical treatment in a disease historically managed through repeated surgical intervention. ZUSDURI's profile as a primary chemoablative therapy represent a fundamentally different approach to treating these patients. Importantly, our clinical data has demonstrated unprecedented complete response and durability of response, offering patients meaningful recurrence-free periods and treatment-free living. Let me provide more detail on the metrics we are tracking. We continue to see strong growth in both unique and repeat prescribers. By the end of the first quarter, we had 256 unique prescribers, up from 102 at year-end. and 103 repeat prescribers, up from 32. This is the most important indicators we track as it reflects growing HCP confidence and successful integration of ZUSDURI into routine urology practice. Importantly, these growth trends were consistent throughout the quarter and not limited to the immediate period following the implementation of the J-code. This gives us confidence in the durability of the launch and supports our expectation for continued growth as we move through Q2 and the rest of the year. Patient enrollment forms, or PEFs, remain an important early indicator of demand, providing visibility into activity at the top of the funnel before it is reflected in new patient starts and revenue. In Q1, we saw continued sequential growth in PEF volume, which we believe reflects strong and expanded health care provider engagement. As we've shared, PEFs, new patient starts and doses all significantly outpaced JELMYTO in Q1, and we expect continued growth across all measures over the course of the year. In terms of conversion, the cycle time from PEF to treatment initiation was approximately 45 to 60 days in Q4, which was expected as sites work through onboarding and workflow integration. In Q1, we continue to see improvement and expect this to continue over the course of the year, moving toward the 2- to 3-week range we see today with JELMYTO. We also see a continued shift toward greater utilization in community practices. In Q4, the mix was approximately 60% hospital and 40% community, and we are now approaching a more balanced mix, closer to 50-50 at quarter end. Given that approximately 70% of the overall market opportunity resides in the community setting, we expect this shift towards community practices will continue and will be an important driver of long-term growth for ZUSDURI. From an access and reimbursement perspective, we have open access across more than 95% of covered lives and reimbursement confidence has significantly improved amongst practices with a permanent J-code for ZUSDURI becoming effective on January 1, 2026. The J-code has been a key catalyst for broader utilization in 2026, especially in the community setting. Looking ahead, we expect continued strong growth throughout 2026. Our focus remains on expanding adoption in the community setting, driving depth of utilization in accounts who have used ZUSDURI and continue to improve patient conversion timelines. In parallel, we are beginning to expand our commercial approach to more directly engage patients, including targeted awareness efforts as we believe patients can be a key catalyst to drive adoption and ZUSDURI is in a unique position of providing both recurrence and treatment-free living. ZUSDURI addresses an estimated $5 billion annual market opportunity in recurrent low-grade intermediate risk non-muscle invasive bladder cancer, and we believe its differentiated clinical profile positions it to capture a meaningful share of that market. As adoption continues to build, we see ZUSDURI as a foundational treatment for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer patients with the potential to evolve into a blockbuster therapy with peak annual revenues exceeding $1 billion. Turning to JELMYTO. We reported revenue of $21.7 million in the first quarter and continue to see a stable, predictable demand profile. We are also continuing to add new users, reflecting sustained confidence among urologists and remain on track to achieve our 2026 sales guidance of $97 million to $101 million. We continue to advance our pipeline, including UGN-103, our next-generation mitomycin-based intravesical therapy, where we will have established a clear regulatory pathway for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We remain on track for our NDA submission in the second half of 2026 with potential approval in 2027. We also plan to expand this product into additional bladder cancer settings as part of our broader life cycle strategy. More broadly, as leaders in uro-oncology, we believe that non-muscle invasive bladder cancer patients need options, and we are committed to developing multiple modalities to address the significant unmet need in this space. Mark will provide more detail on our pipeline in a few moments. Finally, we have a strong balance sheet with approximately $140 million in cash, cash equivalents and marketable securities as of March 31, supported by the refinancing of our term loan with Pharmakon Advisors during the quarter. This provides us with the flexibility to fully support the ongoing launch of ZUSDURI while continuing to invest in our next-generation pipeline with cash runway to and through profitability. Overall, we believe we are well positioned to execute on our strategy, build on our current momentum and deliver meaningful outcomes for our patients while generating long-term shareholder value. I will now turn the call over to Mark for a clinical update. Mark? Mark Schoenberg: Thank you, Liz. The American Urologic Association Annual Meeting will take place May 15 to 18 in Washington, D.C. UroGen will have a significant presence there, and we believe this is an important opportunity to engage with both community and academic urologists and further discuss the clinical value of ZUSDURI and JELMYTO. For UroGen, the national AUA meeting represents a highly relevant and meaningful forum to continue building awareness and health care provider engagement. Bladder cancer will be a central focus of this year's meeting, and it's important to clearly define where ZUSDURI fits within the evolving treatment landscape for NMIBC. In intermediate risk disease, the primary clinical challenge is the management of recurrence rather than progression. Patients commonly experience multiple recurrences, requiring repeated TURBT procedures under general anesthesia over time, which contributes to a significant cumulative treatment burden. Accordingly, both patients and physicians are focused on strategies that reduce the frequency of interventions and enable a more rapid return to normal daily activities. ZUSDURI was specifically designed to address this need. Its clinical benefit is driven by both its efficacy and mode of administration. In the Phase III ENVISION trial, which supported its FDA approval, ZUSDURI demonstrated a robust complete response rate of approximately 80% at 3 months and importantly, durable outcomes over time. At 24 months, the probability of remaining event-free following complete response was approximately 72% based on Kaplan-Meier analysis. These data were recently published in the Journal of Urology and will be featured in a podium presentation at the upcoming AUA Congress. Importantly, median duration of response has not been reached in the ENVISION study at a median follow-up of 23.7 months after 3-month complete response. From a clinical perspective, this level of durability is meaningful as it has the potential to interrupt the cycle of recurrences and decreases patients' treatment burden. In practical terms, it translates into longer recurrence-free intervals and extended periods without treatment. Equally important is how ZUSDURI is delivered. It is administered as a finite 6-dose chemoablative regimen in the outpatient setting without the need for surgery or ongoing maintenance therapy. In our experience, this allows for straightforward integration into routine clinical practice without significant changes to workflow or infrastructure. This approach is distinct from many therapies currently in development, which are typically evaluated in the adjuvant setting and administered following TURBT. These regimens often involve induction and maintenance therapy over extended periods, in some cases, up to 1 year. ZUSDURI by contrast is designed as a primary nonsurgical therapy with a total treatment duration of 6 weeks. Taken together, this approach represents a meaningful shift in how this disease can be managed, offering durable disease control for the finite course of therapy while reducing treatment burden and enabling extended recurrence-free and treatment-free living. As we continue to gain real-world experience, understanding how these clinical benefits translate into routine practice is increasingly important. At the upcoming AUA Annual Meeting, UroGen will host the KOL panel focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns and patient outcomes. This event will be webcast and accessible through the company's website, and we believe it will provide important clinical perspective on how ZUSDURI is being incorporated into routine practice. Turning now to the pipeline. UGN-103 is our next-generation mitomycin-based formulation for recurrent low-grade intermediate risk non-muscle invasive bladder cancer, developed to build on the foundation established by ZUSDURI. It is designed to improve upon the current formulation with a shorter manufacturing process and a more streamlined reconstitution procedure while also having intellectual property coverage into December of 2041. We plan to submit an NDA for UGN-103 in the second half of this year based on results from the Phase III UTOPIA trial, which demonstrated a 77.8% complete response rate at 3 months, consistent with what we observed with ZUSDURI. We are aligned with the FDA that the NDA can be submitted with 6-month durability data with plans to update the filing as 12-month durability data become available. 6-month durability data are expected midyear. And if we receive FDA approval in 2027, we expect the permanent J-code could become effective as early as the beginning of 2028. We also see significant opportunity to expand UGN-103 beyond its initial planned indication. We are actively pursuing development in high-grade NMIBC as well as in the adjuvant setting for intermediate risk disease, both of which represent meaningful opportunities to broaden the impact of this program. We plan to hold Type C meetings with the FDA in the second quarter of 2026 to align on the development plans for both studies with the goal of initiating a Phase III trial in high-grade disease before year-end and in the adjuvant intermediate risk setting thereafter. UGN-104, our next-generation program for low-grade upper tract urothelial cancer continues to progress in a Phase III trial as planned with enrollment expected to complete by the end of 2026. Finally, UGN-501 is our investigational next-generation oncolytic virus therapy being developed as a locally administered treatment for cancer. UGN-501 was specifically designed and genetically engineered to act like chemotherapy initially, producing widespread tumor cell lysis with a subsequent immunomodulatory benefit, which we believe differentiates UGN-501 from other oncolytic viruses in development. IND-enabling studies are nearing completion, and we plan to submit an IND in the second quarter of 2026 and initiate a Phase I clinical trial in NMIBC by year-end. Our nonclinical data support the potential for UGN-501 to be a differentiated oncolytic virus, demonstrating broad and consistent cytotoxic activity across a large panel of bladder cancer cell lines representing a range of tumor stages and grades. These findings reinforce our belief that UGN-501 has the potential to be best-in-class, highly active, locally delivered therapeutic approach in this setting. The Phase I trial will initially evaluate UGN-501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery, including administration with our proprietary RTGel technology, which may enable prolonged dwell time and enhance local activity. While our initial focus is bladder cancer, we believe this platform has the potential to extend beyond the genitourinary setting into additional tumor types over time. I will now hand it over to Chris to discuss our financial results. Christopher Degnan: Thank you, Mark. Q1 represents an important step forward as we begin to see the early commercial momentum of ZUSDURI translate into meaningful revenue growth while continuing to manage our cost structure in a disciplined manner. At the same time, we remain focused on supporting the ongoing launch of ZUSDURI, advancing our pipeline and maintain the financial flexibility needed to execute on our long-term strategy. Now to our financial results. Total revenue was $51 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. The 152% year-over-year increase was primarily driven by the commercial launch of ZUSDURI. And JELMYTO revenue growth also contributed to the increase. Research and development expenses were $15.6 million in the first quarter of 2026 compared with $19.9 million in the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which we recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval. Selling, general and administrative expenses were $51.5 million in the first quarter of 2026 compared with $35 million in the first quarter of 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, an increase in overall commercial operation costs and higher advisory costs, including fees associated with the Pharmakon debt refinancing. We expect Q1 to be the high point of SG&A expense in the year based on phasing of activities and the onetime costs associated with the debt refinancing in the period. Financing expense related to the prepaid forward obligation to RTW Investments was $4.5 million for the first quarter of 2026 compared with $4.6 million in the prior year. Interest expense related to long-term debt was $4.2 million in the first quarter of 2026 compared to $4.1 million in the same period in 2025. The slight increase in interest expense was primarily attributable to the additional borrowings of $75 million in the first quarter of 2026 in connection with the Pharmakon debt refinancing, offset by the lower interest rate. The company reported a net loss of $23.6 million or $0.47 per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million or $0.92 per basic and diluted share in the first quarter of 2025. As of March 31, 2026, cash, cash equivalents and marketable securities totaled $140.3 million. Finally, turning to guidance. The guidance that we provided on the year-end call in March is unchanged. For the full year 2026, net product revenues for JELMYTO are expected to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over 2025. We are not providing formal sales guidance for ZUSDURI in 2026 at this time, given that the product is still in the early stages of its launch. Full year 2026 operating expenses are expected to be in the range of $240 million to $250 million, including noncash share-based compensation expense of $20 million to $24 million. That concludes our prepared remarks. We will now open the call to questions. Operator: [Operator Instructions] Our first question comes from Tara Bancroft from TD Cowen. Tara Bancroft: So congrats on the great quarter. I love to see it. And with this quarter, it appears that you'll pretty significantly exceed the ANKTIVA's demand-driven growth that you previously pointed to as a solid analog for the 6 months post the permanent J-code. So I'm wondering if you have any updated thoughts on how we should think about growth for the rest of the year from here? And maybe is there any other analog that we should look to instead from here? Elizabeth Barrett: Tara, thank you. I'm going to ask Chris to comment, and then I'll add any other commentary. Christopher Degnan: Yes, Tara, thanks for the question. To your point, I mean, we pointed to ANKTIVA, just to remind folks, when we looked at the first 6 months with the permanent J-code, they saw a 220% step-up in their revenue. And to your point, given the performance in Q1, we're tracking ahead of that analog. Again, we're not guiding for the year, but I mean, I think it's important to reiterate a few points from the call. One that we're seeing consistent growth across all our commercial indicators. This wasn't a onetime step-up with the J-code that we saw in January. So these trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that the underlying demand is building in a sustainable way. And as Liz mentioned on the call, we do expect continued growth in Q2 and throughout the year given the early stages of the launch. Elizabeth Barrett: Yes. Unfortunately, Tara, I don't -- we don't have a great analog, to be honest with you, that we could share with you. I think as Chris stated, I think we feel good about where we are. We expect to continue to grow. We do want to caution everybody that quarter-over-quarter growth is not likely to be the same and as we go forward as it was in the Q1 versus Q4 because of the J-code dynamics, but we do expect to continue to see quarter-over-quarter growth. So I wish we could give you an analog. I think we're happy with where we are. We'll continue to see growth and think we're in a good place. And -- but right now, we're just not in a good position to provide any additional guidance beyond that. Operator: Our next question comes from Kelsey Goodwin from Piper Sandler. Kelsey Goodwin: Congrats on the really strong quarter. That's wonderful. Two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting ZUSDURI? What kind of patients are getting ZUSDURI now? And when patients recur, how do you get ZUSDURI to kind of be that first product that physicians reach for? And then secondly, on reimbursement. Now that the physicians are getting more comfortable post permanent J-code, I guess maybe could you provide some color on what kind of cost sensitivity you're seeing given ZUSDURI is priced relatively lower than some of the high-risk programs at about $130,000 price range? Elizabeth Barrett: Kelsey, great questions. One, I can give you anecdotally, but we don't track, obviously, how many TURBTs. That information just isn't available. What we're hearing in the beginning is most of the patients that are getting treated in the beginning are those that have had at least 2 or 3 TURBTs. Having said that, we do have physicians that have already adopted ZUSDURI as sort of their standard of care and so for a recurrent patients. And what I mean by that is they're looking -- we do have physicians who have treated several patients into the high teens. And so they are really adopting it across the entire paradigm of patients. So I think we will get there, and we want to be very careful, and that's one of the things we also are very careful with our sales team is that we don't niche ourselves into those that have had multiple TURBTs. Keeping in mind that 23% have had 5 or more and 68% have had 2 or more. So even if we did have those patients, it's still a large number of patients, but we want to make sure that everybody understands. And particularly if you look at our clinical study, a lot of those patients only had 1 or 2. And so we are seeing again. But initially, it's the expectation, and this happens across all of oncology, you typically start with your later line of patients and then move up after they see good results. So that's kind of where we are with that. On the cost sensitivity, it's kind of an interesting position for us to be in because obviously, the ones that you're talking about are all high grade. And so it's hard to -- but we do get lumped in, unfortunately, when they talk about a high-priced drug, they are lumping us in there. So we have to continuously remind everybody, to your point, that our price is significantly less. And we also want to bring that awareness as those high-priced drugs start to move into the low-grade space. When we developed our pricing, it was specifically for the low-grade patients and also take into consideration the duration of therapy because one of the reasons that ours is $130,000 is because you only have 6 doses and you're done. You don't need to continue maintenance. Whereas you look at the other players in the market, both for high-grade and those coming into IR, they have maintenance therapy. So you're talking about 6 doses versus 14-plus doses, that also increases the price. So we hope that not only that physicians, payers see the value and the value price that we have, and I think we've been very responsible from that standpoint for the patient population that we're talking about. Operator: Our next question comes from Amin Makarem from Jefferies. Mohamad Amin Makarem: Congrats on the quarter. Two from us. First, just following up on the prior question. Can you comment on 2Q demand trends versus 1Q so far, what you're seeing on the field? And whether you're seeing any acceleration early in this quarter? And then the second one, within the new prescribers, how does the mix break down between community versus academic? And are you seeing a meaningful differences in demand across these groups already early in this launch? Elizabeth Barrett: Yes. Chris, do you want to comment and then I'll... Christopher Degnan: Sure. I mean, thanks for the question. So in terms of Q2, I mean, obviously, early stages of Q2, but I would say not necessarily acceleration, but just continued demand growth. As I said, we saw continued growth month-over-month through Q1. And I would say that trend continues in the early stages of Q2. And in terms of mix, as Liz mentioned on the call, 60% of our business was in the hospital setting last year, and we've already now exceeded 50% mix in the community setting in Q1. And so that is a big part of our growth, and we expect that to continue to shift more and more towards the community practices throughout the course of the year. And just a reminder, 65%, 70% of these patients are treated in the community setting. So that's a big piece with the J-code being in place and opening up those practices for us. Elizabeth Barrett: Yes. I think it's also just important to note that community very important, but also a lot of the academic centers who do have a lot of these patients, they also keep continue to come on board. So we have some large academic centers that we've just received in the last month, the formulary, positive formulary decision. So you'll see some new academic centers coming on board as well. So it's a continuous thing. But obviously, most of those patients, low-grade patients do get treated in the community as we grow community, but also important that we also support the institutions as they are big drivers also of the adoption. Operator: Our next question comes from Michael Schmidt from Guggenheim. Michael Schmidt: Congrats on a great first quarter. Yes, maybe just another follow-up on ZUSDURI. Could you just comment if you're seeing a change perhaps in the type of patients that are choosing ZUSDURI now over TURBT. I think initially, you spoke about the preference by patients who are high risk, surgery high risk or elderly type patients. I'm just curious if that's shifting a bit now that the product has been on the market longer. And then maybe bigger picture, how do you think about the intermediate risk market evolving longer term with the potential entry of adjuvant therapies in the future post TURBT? And how could that impact the landscape as you think about ZUSDURI use long term? Elizabeth Barrett: Yes. No, great. Michael, I love the word when you said "patients choosing." I will say that, yes, we are seeing across the board, different types of patients getting -- being able to get ZUSDURI. I think your -- in your comment about that, I will also say -- I'll also answer as part of your second question. what we are finding and what we're hearing, and this is anecdotal, right? So I just want to be very careful about that is we are starting to see and hear about patients requesting ZUSDURI. We're hearing things like, oh, I want that gel stuff. And so patients as they're starting to hear more about that, one of the ways that we believe we can clearly differentiate ourselves versus the market as the market evolves is given that we are the treatment that does not have surgery, yet we have very meaningful clinical results. And so when you talk to patients, they don't want another surgery. So while at the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because they -- it's just -- it's in their nature to cut it out and then come back with another therapy. I think you're going to see that patients are going to be opposed to that. And patients are going to want to say, "Hey, let me see how this one works without surgery", because you can go back and have surgery. I'll give you an example. We just heard about a patient who had multiple recurrences and very close together, use ZUSDURI and she did have 2 small lesions, which were able to be fulgurated in the office. So I think more and more as you start to hear about that, then I think our drug will get used less in the adjuvant. It does get used. We do know the physicians that are even using ZUSDURI right now after surgery. But again, one of the biggest benefits we can provide and why we believe we will be the patient's choice for a treatment is because not only do you not have to have surgery, but you also don't have to have maintenance therapy. So it's a clear differentiator for us. And given the results, you have to look at the complete response and the durability that we have without surgery. So to your point, I think it will continue to evolve. I think there'll be opportunity for others in the space. I think more companies and more drugs being introduced will help to grow the market. And as we've talked about before, even given our -- the pricing of our medicine and the use of only 6 weekly doses, we still believe we will have over $1 billion revenue drug with only less than a 20% market penetration. So I think there's plenty of room for the category and for the area to evolve, but I also believe that we have a clear differentiator versus anyone coming in and especially even today, there's no one coming in, in the near future. So it's going to be a couple of years before there's others coming in. But our ability to offer patients an opportunity to not go through surgery, but still get very meaningful results is very critical. Operator: Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co. Raghuram Selvaraju: Just 3 quick ones from us. Firstly, I was wondering if you could give us a sense of where you expect the timing between receipt of a patient enrollment form and finalization of reimbursement for ZUSDURI to be by the end of 2026, given the impact of the J-code. Secondly, I was wondering if you could talk a little bit further about the community hospital contribution at steady state to the ZUSDURI revenue base just on a percentage basis? And also if there are any specific nuances between what you see as the receptivity at the community setting relative to the academic setting? And then lastly, I was wondering if you could just provide us with a few words on JELMYTO and what you see as the long-term future for that product, as well as the life cycle management initiative with 104. Can we expect some reacceleration of JELMYTO uptake? Do you think that there is some incremental gain to be made on that front with that product? And perhaps most importantly, are you seeing some renewed interest in JELMYTO given the receptivity you've seen so far with ZUSDURI among prescribing physicians? Elizabeth Barrett: Yes. I'm going to actually go backwards, if that's okay, Ram. And then I'll leave the last question for -- which is your first question, and I'll turn it over to Chris. On JELMYTO, look, we expect, as I mentioned in the remarks, just to continue to see the sort of predictable growth where we are. So we will continue to see low single-digit growth. That's what we've been talking about. The good news is that we do see -- continue to see new users of JELMYTO. The issue for JELMYTO always comes around finding the patients. So as we go out and talk about ZUSDURI, when even before ZUSDURI may be on formulary, they're hearing about JELMYTO, we're getting new users using JELMYTO. So every quarter, we have new physicians using JELMYTO. So we expect that to continue. And again, the challenge there is really where the patient presents. So you may have a doctor this quarter and that doctor won't see another JELMYTO patient for 2, 3, 4 quarters. And so a lot of that -- so while we expect to continue this low single-digit growth, we also do expect there to be continued new users of JELMYTO. And I think ZUSDURI will help that, and we've talked about that before. With UGN-104 coming in, it will be interesting to see the data with UGN-104. And the only reason I say that is because if you recall, the stricture rate for JELMYTO was high because of the way that the FDA required that we characterize that. And so we had some physicians who see that and get a little bit worried about that. But now that the nephrostomy tube is at least half of the usage and the clinical study, we'll have to see how that comes out in the clinical study. And also given the long-term durability of JELMYTO, and we're seeing very similar results with ZUSDURI. And so I think all of those things point to our ability to continue to grow the low single digits for JELMYTO. So -- and the fact that we'll continue to grow the number of doctors that we're calling on with ZUSDURI, and that will also help JELMYTO. On the community versus the hospital, where we end up, my guess is going to be more of a 60-40 situation where most of it is coming from the community because that's just where the patients get seen. I mean that's reality. Having said that, I don't want to negate the fact that the institutions are very important. And that's -- a lot of that is because once these patients have been treated multiple times, they tend to be sent to an institution or an academic institution. And we also know that they tend to be high-volume accounts. And so while we expect ultimately the community to be bigger, we -- the institutions will always be a major part of ZUSDURI. And we have some institution physicians who have already become real champions and advocates of ZUSDURI, as I mentioned before, are using it on most of their patients. And they're seeing -- and I'm sure you heard last week with Dr. Chamie, he's seeing more patients than he frankly thought he would -- that are appropriate for ZUSDURI. And I think we're hearing that more and more. So I think that's where we'll end up. And then I'll just ask Chris to talk a little bit about the conversion timing and where we expect it to be by end of 2026. So Chris? Christopher Degnan: Thanks, Ram. So from PEF to new patient starts, as we talked about, last year was roughly 45 to 60 days. And a lot of that less so the benefit verification, which only takes a few days once it's submitted to the hub. It was more of the operational pieces and also as more use was in the hospital last year, just getting on hospital formulary, et cetera. So we do expect as this gets adopted into clinical workflows that our time to conversion is going to compress. And we did see that already in Q1. So average time to conversion in Q1 was 30 to 35 days. So we're starting to see that walk down, and we expect ultimately in steady state to be closer to where we are today for JELMYTO, which is 2 to 3 weeks from PEF to new patient start. Operator: Our last question comes from Paul Choi from Goldman Sachs. Kyuwon Choi: Let me add my congratulations on the good results. Liz, I was wondering if you can maybe provide some color on where the ZUSDURI uptake is happening. Specifically, what is the sort of percentage of overlap with existing JELMYTO users versus prescribers who are just new and outside your current commercial base or prior commercial base? And my second question for Mark is, I was wondering if you could expand a little bit more on UGN-103 development plans and potentially an adjuvant trial that seems to be the direction of travel for some of your competitors and just what that kind of trial in your mind might look like for UGN-103? Elizabeth Barrett: Yes. Sure, Paul. Mark, would you like to start there? Mark Schoenberg: Yes, sure. Thanks, Liz. Thank you, Paul. So yes, we are excited about UGN-103's NDA submission this year and an expected approval for the successor molecule for ZUSDURI. In terms of expanding the label or the indication into other aspects of the disease spectrum, we certainly are in the process of finalizing conversations about what trials would look like as adjuvant therapy for newly diagnosed intermediate risk disease and also for high-grade high-risk disease. Both of those trial designs anticipate prospective randomized adjuvant therapy with the control arm, and we are in the process of finalizing the details of those trials, and we anticipate initiating the high-grade trial this year. That's our current plan. Elizabeth Barrett: Yes. I think the only additional comment I'll make about that is I still hold to what I said earlier in the IR space is that I think doing it without having to do surgery is a real benefit. Having said that, because some physicians want to, it's probably in our best interest to at least generate some data of using ZUSDURI in the adjuvant setting. So it's one of the reasons we're doing what Mark was talking about. To go to your first question around JELMYTO overlap, absolutely. And some of our initial users are JELMYTO users, and we see today over 50% of the ZUSDURI users are JELMYTO users. That's not surprising, obviously, because the 95% of JELMYTO users are ZUSDURI or potential ZUSDURI. It doesn't -- the flip side is not necessarily the case given the rare nature of the upper tract urothelial carcinoma. But -- so we're seeing again now in the beginning, I would say it was even higher. We started out -- some of our initial users were JELMYTO users, so probably 80% but now it's a little over 50%. So we're seeing both the JELMYTO and non-JELMYTO users using ZUSDURI. So I hope that helps, Paul. Kyuwon Choi: Yes, it does. Operator: We have the one last question and last question will be from Leland Gershell from Oppenheimer. Leland Gershell: Terrific to see ZUSDURI hitting its stride here. Just Liz and team, I wanted to ask, I appreciate the additional launch metrics that you provided. It looks like you're making solid progress there on activated sites and prescribers. If you would -- wondering if you could share with us where you may be sort of in the context of your overall rollout plan with respect to goals of those various metrics. Elizabeth Barrett: Thanks, Leland, and thanks for the support. Very, very early. So we're nowhere near where we want to be. We have a target of 8,500 doctors, health care providers. And we're -- as we talked about today, we've only got 300 unique prescribers. So we have a long way to go. But I think that's great news, right? It's good news for us because that means the opportunity since we're already seeing the great results so far in Q1, we believe that those that have used it, we're getting very positive feedback, but we have a long way to go with new users, and we'll continue to add new users. And part of our -- I mean, our strategy is both breadth and depth because we also do know that those physicians who have already used it have more patients that they could use it on. But absolutely, we have a long way to go. So we're just in the very, very early stages of where we want to be with penetration among docs. So a long way to go, very, very early in early stages. Operator: I'm showing no further questions. This concludes the question-and-answer session. I would now like to turn it back to Liz Barrett for closing remarks. Elizabeth Barrett: Thanks. I'm sorry about that. Just wanted to say thank you to everybody who have been supportive of us for a long time. I think we're finally starting to see the results that we've always known that we could bring. I think the most important thing that we really like to focus on is the impact that we're having on patients because we really do believe if you do the right thing for the patients, the business and our shareholders will be rewarded for that. So thanks for all the support. Happy to continue to share progress as we get into Q2 and beyond. So thanks again for everybody's support, and we will talk to you guys soon. You can disconnect now, operator. Operator: Thank you for your participation in today's conference. This concludes the program. You may now disconnect. 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Interested in Urogen Pharma? Here are five stocks we like better. ZUSDURI launch accelerated after a permanent J‑code in January, generating $29.2 million in Q1 revenue (>100% quarter‑over‑quarter) with prescriber adoption rising to 256 unique and 103 repeat prescribers and conversion times improving to ~30–35 days toward a target of two to three weeks. Clinical and pipeline momentum: Phase III ENVISION showed ~80% complete response at three months and ~72% 24‑month event‑free probability among responders, and UroGen plans an NDA for next‑generation UGN‑103 in H2 2026 (potential approval in 2027) while advancing UGN‑104 and preparing an IND for UGN‑501 in Q2 2026. Financials and guidance: total revenue was $51.0 million in Q1 driven by ZUSDURI and JELMYTO, net loss narrowed to $23.6 million, SG&A rose due to commercialization and refinancing costs, and management maintained JELMYTO guidance of $97–101 million and full‑year operating expense guidance of $240–250 million while providing no formal ZUSDURI sales forecast for 2026. 3 Bullish Biotech Stocks With Explosive Growth Trends Urogen Pharma (NASDAQ:URGN) reported first-quarter 2026 results that management said showed accelerating early momentum from the commercial launch of ZUSDURI, driven in part by the implementation of a permanent J-code in January. The company posted $29.2 million in ZUSDURI revenue for the quarter, which Chief Executive Officer Liz Barrett said represented “more than 100% quarter-over-quarter growth.” “As expected, the implementation of the permanent J-code in January marked a major inflection point,” Barrett said, adding that early launch momentum is now translating into “expanded utilization and meaningful growth.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Barrett opened the call by noting a leadership change tied to the ZUSDURI launch. She said the board and management decided “a few months ago” that she would assume direct oversight of the commercial organization, which resulted in the departure of David Lynn. Barrett said the change has improved agility and decision-making as the company executes on the launch. Barrett emphasized ZUSDURI’s positioning as “the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer,” describing it as a non-surgical, primary chemoablative approach in a setting historically treated with repeated surgical intervention. → A Prada Payday: Is AMC Back in Style? In detailing launch indicators, Barrett said prescriber adoption continued to build during the quarter: 256 unique prescribers by quarter-end, up from 102 at year-end 103 repeat prescribers, up from 32 Barrett said repeat prescribers are “the most important” indicator the company tracks because they reflect healthcare provider confidence and integration into routine practice. She added that the growth was consistent throughout the quarter and “not limited to the immediate period” after the J-code went into effect, which she said supports expectations for continued growth through the rest of the year. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% The company also discussed patient enrollment forms (PEFs) as an early measure of demand. Barrett said PEF volume grew sequentially in the quarter and that PEFs, new patient starts, and doses “all significantly outpaced JELMYTO in Q1.” Management highlighted improving conversion timing and expanding community uptake. Barrett said the cycle time from PEF to treatment initiation was approximately 45–60 days in the fourth quarter, reflecting onboarding and workflow integration, and that the company saw improvement in the first quarter with expectations to move toward the “two to three week range” seen with JELMYTO over time. Chief Financial Officer Chris Degnan later provided more specific conversion figures, stating that the average time to conversion in the first quarter was “30–35 days,” and that the company expects steady-state conversion to resemble JELMYTO at roughly two to three weeks from PEF to new patient start. Barrett said the site-of-care mix is shifting toward community practices, which management views as critical given where most patients are treated. She said the mix moved from about 60% hospital and 40% community in the fourth quarter to a more balanced split “closer to 50/50” by the end of the first quarter. Degnan said the company had “exceeded 50% mix in the community setting in Q1” and expects a continued shift throughout the year. On reimbursement, Barrett said UroGen has “open access across more than 95% of covered lives,” and that reimbursement confidence improved significantly with the permanent J-code. In response to analyst questions, she also addressed pricing and treatment duration, noting ZUSDURI’s six-dose regimen and the absence of maintenance therapy as key differentiators compared to longer-duration regimens. Chief Medical Officer Mark Schoenberg said UroGen expects a “significant presence” at the American Urological Association annual meeting May 15–18 in Washington, D.C., calling it an important opportunity to engage urologists and discuss the clinical value of ZUSDURI and JELMYTO. Schoenberg reviewed data from the Phase III ENVISION trial that supported ZUSDURI’s approval. He said ZUSDURI showed a complete response rate of approximately 80% at three months, with Kaplan-Meier estimates indicating a 24-month probability of remaining event-free of approximately 72% among complete responders. He added that median duration of response has not been reached at a median follow-up of 23.7 months after a three-month complete response. Schoenberg said the findings were recently published in The Journal of Urology and will be featured in a podium presentation at AUA. He also emphasized ZUSDURI’s administration as a finite six-dose outpatient regimen without surgery or maintenance therapy, contrasting it with therapies in development that are often evaluated in the adjuvant setting following TURBT and can involve induction and maintenance over extended periods. Schoenberg outlined several pipeline programs, led by UGN-103, a next-generation mitomycin-based intravesical therapy for recurrent low-grade intermediate-risk NMIBC. He said UGN-103 is intended to improve manufacturing and reconstitution versus the current formulation and has intellectual property coverage into December 2041. UroGen plans to submit an NDA for UGN-103 in the second half of 2026 based on Phase III UTOPIA trial results, which Schoenberg said showed a 77.8% complete response rate at three months. He said the company is aligned with the FDA that the filing can be submitted with six-month durability data, with plans to update the NDA as 12-month durability data become available. Six-month durability data are expected mid-year, he said, and UroGen expects that if UGN-103 is approved in 2027, a permanent J-code could become effective “as early as the beginning of 2028.” Schoenberg added that UroGen is pursuing expansion opportunities for UGN-103 in high-grade NMIBC and in the adjuvant setting for intermediate-risk disease. He said the company plans Type C meetings with the FDA in the second quarter of 2026 to align on development plans, with the goal of initiating a Phase III trial in high-grade disease before year-end and an adjuvant intermediate-risk study thereafter. Separately, Schoenberg said UGN-104, a next-generation program for low-grade upper tract urothelial cancer, is progressing in a Phase III trial with enrollment expected to complete by the end of 2026. He also discussed UGN-501, an investigational oncolytic virus therapy designed for local administration. Schoenberg said UroGen plans to submit an IND in the second quarter of 2026 and initiate a Phase I clinical trial in NMIBC by year-end. The first Phase I evaluation will use aqueous intravesical administration, while the company also plans to explore delivery using its RTGel technology to potentially extend dwell time. Degnan reported total revenue of $51.0 million for the quarter ended March 31, 2026, compared with $20.3 million in the prior-year period, driven primarily by ZUSDURI’s launch and contributions from JELMYTO growth. JELMYTO revenue was $21.7 million in the first quarter, which Barrett characterized as stable and predictable, and she said the company remains on track to meet its 2026 JELMYTO sales guidance. R&D expense was $15.6 million, down from $19.9 million a year earlier. Degnan attributed the decrease primarily to the prior-year acquisition of UGN-501 and to ZUSDURI manufacturing costs that were recognized as R&D before FDA approval. SG&A expense rose to $51.5 million from $35.0 million, which Degnan said was primarily due to ZUSDURI commercial activities, including sales force expansion and marketing, as well as higher advisory costs tied to the company’s Pharmakon debt refinancing. Degnan said the first quarter is expected to be the high point of SG&A expense for the year due to phasing and one-time refinancing costs. UroGen reported a net loss of $23.6 million, or $0.47 per share, compared with a net loss of $43.8 million, or $0.92 per share, in the first quarter of 2025. Cash, cash equivalents, and marketable securities totaled $140.3 million as of March 31, 2026. For guidance, Degnan said the company’s outlook is unchanged from the year-end call. UroGen expects full-year 2026 JELMYTO net product revenue of $97 million to $101 million and full-year operating expenses of $240 million to $250 million, including $20 million to $24 million of non-cash share-based compensation. Degnan said the company is not providing formal ZUSDURI sales guidance for 2026 because the product remains in the early stages of launch. On the Q&A, management said ZUSDURI demand indicators continued to rise into the early part of the second quarter. Degnan said the company was not seeing a distinct acceleration, but rather “continued demand growth,” while Barrett cautioned that quarter-over-quarter growth rates may not match the step-change seen from the J-code dynamics between the fourth and first quarters. Barrett also said that while early ZUSDURI use skewed toward patients with multiple prior TURBTs, physicians are increasingly adopting the therapy more broadly within the recurrent setting. She noted anecdotal feedback of patients requesting the treatment and argued that avoiding surgery and maintenance therapy could remain a key differentiator as the treatment landscape evolves. UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for uro-oncology and uro-genital diseases. Founded in 2010 and headquartered in Ra'anana, Israel, with offices in New York, UroGen applies its proprietary RTGel® reverse thermal gel delivery platform to create sustained-release formulations designed for in-office use by urologists. The company's lead product, Jelmyto® (mitomycin gel), received U.S. Food and Drug Administration approval in 2020 for the treatment of adults with low-grade upper tract urothelial cancer. The article "Urogen Pharma Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.