URGN - NASDAQ
UroGen Pharma Ltd.
URGN·NASDAQ
$27.79
+4.7%HealthcareBiotechnology
UroGen Pharma Ltd., a biotechnology company, engages in the development and commercialization novel solutions for specialty cancers and urothelial diseases. It offers RTGel, a polymeric biocompatible and reverse thermal gelation hydrogel to improve therapeutic profiles of existing drugs; and Jelmyto for pyelocalyceal solution. The company's lead product candidate is UGN-102, which is in Phase III clinical trials for the treatment of several forms of non-muscle invasive urothelial cancer that include low-grade upper tract urothelial carcinoma and low-grade non-muscle invasive bladder cancer. It is also developing UGN-301 for the treatment of high-grade non-muscle invasive bladder cancer. The company has a license agreement with Allergan Pharmaceuticals International Limited for developing and commercializing pharmaceutical products that contain RTGel and clostridial toxins; Agenus Inc. to develop, make, use, sell, import, and commercialize products of Agenus for the treatment of cancers of the urinary tract via intravesical delivery; and strategic research collaboration with MD Anderson to advance investigational treatment for high-grade bladder cancer. UroGen Pharma Ltd. was incorporated in 2004 and is based in Princeton, New Jersey.
At a Glance
Live SnapshotMarket Cap$1.35B
EPS-3.1900
P/E Ratio-8.71
Earnings Date08/06/2026
Earnings Call Transcript
URGN • 2026 • Q1
Operator
Good day. Thank you for standing by. Welcome to the UroGen Pharma Q1 2026 results earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Senior Director of IR.
Vincent Perrone
Thank you. Good morning, everyone, and welcome to UroGen Pharma's 1st 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 March 31, 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.
Vincent Perrone
These may include statements regarding our ongoing commercialization activities related to
Liz Barrett
Thanks, Vincent. Good morning, thank you for joining us today. Before I provide our business update, I wanted to share that given the critical importance of a successful
Liz Barrett
As expected, the implementation of the permanent J-code in January marked a major inflection point. 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
Liz Barrett
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
Liz Barrett
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 healthcare 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 45-60 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 2-3-week range we see today with JELMYTO.
Liz Barrett
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
Liz Barrett
Our focus remains on expanding adoption in the community setting, driving depth of utilization in accounts who have used
Liz Barrett
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-$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 lifecycle strategy.
Liz Barrett
More broadly, as leaders in urooncology, 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 equivalents, and marketable securities as of March 31st, 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
Liz Barrett
I will now turn the call over to Mark for a clinical update. Mark?
Mark Schoenberg
Thank you, Liz. The American Urological Association annual meeting will take place May 15th to 18th 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
Mark Schoenberg
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.
Mark Schoenberg
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
Mark Schoenberg
Taken together, this approach represents a meaningful shift in how this disease can be managed, offering durable disease control with a 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 a KOL panel focused on real-world experience with
Mark Schoenberg
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
Mark Schoenberg
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.
Mark Schoenberg
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. 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.
Mark Schoenberg
The phase I trial will initially evaluate UGN-501 via aqueous intravesical administration. In parallel, we plan to explore additional modes of delivery, including an administration with our proprietary RTGel technology, which may enable prolonged dwell time and enhanced 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.
Chris Degnan
Thank you, Mark. Q1 represents an important step forward as we begin to see the early commercial momentum of the story 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
Chris Degnan
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
Chris Degnan
We expect Q1 to be the high point of SG&A expense in the year based on phasing of activities and the one-time 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.
Chris Degnan
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 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-$101 million. This implies a year-over-year growth rate of approximately 3%-7% over 2025.
Chris Degnan
We are not providing formal sales guidance for
Operator
Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft from TD Cowen. Tara, the line is open.
Tara Bancroft
Hi. Good morning. Congrats on the great quarter. Love to see it. You know, with this quarter, it appears that you'll pretty significantly exceed the ADSTILADRIN's demand-driven growth that you previously pointed to as a solid analog for, you know, those six months post the permanent J-code. I'm wondering if you have any updated thoughts on how we should think about growth for the rest of the year from here. Maybe is there any other analog that we should look to instead from here? Thanks.
Liz Barrett
Hi, Tara. Thank you. I'm gonna ask Chris to comment, and then I'll add any other commentary.
Chris Degnan
Yeah, Tara, thanks for the question. To your point, I mean, we pointed to ADSTILADRIN, just to reground folks, where we looked at the first 6 months with the permanent J-code. You know, they saw a 220% step-up in their revenue. To your point, you know, given the performance in Q1, you know, we're tracking ahead of that analog.
Chris Degnan
Again, we're not guiding for the year, I mean, I think it's important to reiterate a few points from the call. One, that we're seeing, you know, consistent growth across all our commercial indicators. This wasn't a one-time step up with the J-code that we saw in January. These trends that we're seeing are progressing consistently throughout the quarter and into Q2, which gives us confidence that, you know, the underlying demand is building in a sustainable way. As Liz mentioned on the call, we do expect, you know, continued growth in Q2 and throughout the year, given the early stages of the launch.
Liz Barrett
Yeah. Unfortunately, Tara, we don't have a great analog, to be honest with you know, that we could, we could share with you. I think, you know, as Chris stated, you know, I think we feel good about, you know, where we are. You know, we expect to continue to grow. We do wanna caution everybody that, you know, quarter-over-quarter growth is not likely to be the same, you know, as we go forward as it was in the Q1 versus Q4 because of the J-code dynamics. We do expect to continue to see quarter-over-quarter growth. I wish we could give you an analog. I think, you know, we're happy with where we are. We'll continue to see growth and, you know, think we're in a good place.
Liz Barrett
Right now we're just not in a good position to provide any additional guidance beyond that.
Tara Bancroft
Okay, great. Yeah, understand completely. Thanks so much for that.
Liz Barrett
Thanks. Appreciate it.
Operator
Thank you. One moment for our next question. Our next question comes from Kelsey Goodwin from Piper Sandler. Kelsey, the line is now open.
Kelsey Goodwin
Perfect. Hey, thanks so much for taking our questions, and congrats on the really strong quarter. That's wonderful news. Two questions from us. First, could you provide more color on how many TURBTs these patients are receiving prior to getting
Liz Barrett
Yeah. Hi, Kelsey. Great questions. You know, one, I can give you anecdotally, but we don't track obviously how many TURBTs. That information just isn't available. You know, 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
Liz Barrett
You know, I think we will get there and we wanna be very careful. That's one of the things we also were very careful with our sales team, is that we don't niche ourselves into those that have had multiple TURBTs. Keeping in mind that, you know, 23% have had 5 or more and 68% have had 2 or more. Even if we did have those patients, it's still a large number of patients, but we wanna make sure that everybody understands. Particularly if you look at our clinical study, a lot of those patients only had 1 or 2, we are seeing again. Initially it's the expectation, and this happens across all of oncology.
Liz Barrett
You typically start with your later line of patients and then move up after they see good results. That, 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. We do get lumped in unfortunately with the-- 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. We also want to bring, you know, that awareness as those high-priced drugs start to move into the low-grade space. You know, when we developed our pricing, it was specifically for the low-grade patients.
Liz Barrett
Also, you know, 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. You're talking about 6 doses versus 14+ doses. That also increases the price. You know, we hope that, you know, 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.
Kelsey Goodwin
Perfect. Super helpful. Thanks so much, and congrats again.
Liz Barrett
Thanks. Appreciate it, Kelsey.
Operator
Thank you. One moment for our next question. Our next question comes from Ami Fadia from Jefferies.
Ami Fadia
Hi. Thank you for taking our questions, and congrats on the quarter. Two from us. First, just following up on a prior question. Can you comment on 2Q demand trends versus 1Q so far, what you're seeing on the field? Whether you're seeing any acceleration early in this quarter. The second one, within the new prescribers, how does the mix break down between community versus academic? Are you seeing a meaningful differences in demand across these groups already early in this launch?
Liz Barrett
Yeah. Chris, you wanna comment and then I'll-
Chris Degnan
Sure. I mean, thanks for the question. In terms of Q2, I mean, obviously early stages of Q2, but I would say, you know, not necessarily acceleration, but just continued demand growth. As I said, you know, we saw continued growth month-over-month through Q1, I would say that trend continues into the early stages of Q2. In terms of mix, you know, as Liz mentioned on the call, you know, 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. That is a big part of our growth. We expect that to continue to shift more and more towards the community practices throughout the course of the year.
Chris Degnan
Just a reminder, you know, 65%, 70% of these patients are treated in the community setting. That's a big piece with the J-code being in place and opening up those practices for us.
Liz Barrett
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 continue to come on board. We have some large academic centers that we've just received in the last month, the formulary, positive formulary decision. You'll see some new academic centers coming on board as well. It's a continuous thing, but, you know, obviously, most of these patients, low-grade patients do get treated in a community. As we grow community, but also important that we also support the institutions as they are big drivers also of the adoption. Thanks for your questions.
Chris Degnan
Thanks.
Operator
Thank you. One moment for our next question. Our next question comes from Michael Schmidt from Guggenheim. Michael, the line is now open.
Michael Schmidt
Oh, hey guys. Good morning. Thanks for taking my question. Congrats on a great first quarter. Yeah, maybe just another follow-up on
Liz Barrett
Yeah. No, great. Michael, I love the word when you said, quote-unquote, "patients choosing." I will say that, yes, we are seeing across the board, different types of patients getting, being able to get
Liz Barrett
You know, we're hearing things like, "Oh, I want that gel stuff." 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. When you talk to patients, they don't want another surgery. At the adjuvant setting, I believe that you'll always have those physicians who want to do surgery because they, you know, it's just, it's in their nature to cut it out and then come back with another therapy.
Liz Barrett
I think you're gonna see that patients are gonna be opposed to that, patients are gonna want to say, "Hey, let me see how this one works without surgery," because you can, you know, 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, used
Liz Barrett
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. It's a clear differentiator for us. Given the results, you have to look at the complete response and the durability that we have without surgery. You know, to your point, I think it will continue to evolve. I think there'll be opportunity for others in this space. I think more companies and more drugs being introduced will help to grow the market.
Liz Barrett
You know, as we've talked about before, even given our, you know, the pricing of our medicine and the use of only 6 weekly doses, we still believe that we'll have over a billion-dollar revenue drug with only less than a 20% market penetration. 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. Especially even today when there's no one coming in in the near future. It's gonna be a couple of years before there's others coming in. Our ability to offer patients an opportunity to not go through surgery but still get very meaningful results is very critical.
Operator
Thank you. One moment for our next question. Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright & Co.
Raghuram Selvaraju
Thanks so much for taking my questions. 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
Raghuram Selvaraju
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 lifecycle management initiative with UGN-104. Can we expect, you know, some re-acceleration of JELMYTO uptake? Do you think that there is some incremental gain to be made on that front with that product? Perhaps most importantly, are you seeing some renewed interest in JELMYTO given the receptivity you've seen so far with
Liz Barrett
I'm gonna 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, what we expect is, as I mentioned in the remarks, to continue to see this sort of you know, predictable growth where we are. 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. As we go out and talk about
Liz Barrett
Again, the challenge there is really where the patient presents. You may have a doctor this quarter, and that doctor won't see another Jelmyto patient for 2, 3, 4 quarters. 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
Liz Barrett
Now that the nephrostomy tube is at least half of the usage and the clinical study, you know, we'll have to see how that comes out, you know, in the clinical study. Also given the long-term durability of JELMYTO, and we're seeing, you know, very similar results with
Liz Barrett
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, you know, treated multiple times, they tend to be sent to, you know, an institution or an academic institution. We also know that they tend to be high volume, you know, high volume accounts. While we expect ultimately, you know, the community bigger, we the institutions will always be a major part of
Liz Barrett
They're seeing, I'm sure you heard last week with Dr. Chamy, you know, he's seeing more patients than he frankly thought he would that are appropriate for
Chris Degnan
Yeah. Thanks, Ram. You from path to new patient start, as we talked about, you know, last year was roughly 45 to 60 days, and a lot of that.
Chris Degnan
Less so the benefit verification, which only takes, you know, a few days once it's submitted to the hub. It was more the operational pieces and also as, you know, more use was in the hospital last year, just getting on hospital formulary, et cetera. We do expect, you know, as this gets adopted into clinical workflows that our time to conversion is going to compress. We did see that already in Q1. Average time to conversion in Q1 was 30-35 days. 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 2-3 weeks from path to new patient start.
Raghuram Selvaraju
Great. Thank you so much, and congrats on all the recent progress.
Liz Barrett
Thanks, Ram.
Operator
Thank you. Our last question comes from Paul Choi from Goldman Sachs. Paul, the line is now open.
Paul Choi
Thank you. Thanks for taking our questions. Let me add my congratulations on the good results. Liz, I was wondering if you could maybe provide some color on where the
Liz Barrett
Yeah, sure, Paul. Mark, would you like to start there?
Mark Schoenberg
Yeah, sure. Thanks, Liz. Thank you, Paul. Yes, we are excited about UGN-103's NDA submission this year and expect expected approval for the successor molecule for
Liz Barrett
Yeah. I think the only additional comment I'll make about that is, you know, 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, you know, because some physicians want to, it's probably in our best interest to at least generate some data of using
Liz Barrett
That's not surprising, obviously, because, you know, the 95% of gemcito users are
Paul Choi
Yes, it does. Thank you very much, Liz.
Liz Barrett
Okay. Thank you.
Operator
Thank you. We have one last question. The last question will be from Leland Gershell from Oppenheimer. Leland, the line is open.
Leland Gershell
Great. Thanks for taking our questions, terrific to see
Liz Barrett
Yeah. Thanks, Leland, and thanks for the support. very, very early, you know, so we're nowhere near where we wanna be. you know, we have a target of 8,500 doctors, healthcare providers, and, you know, we're, as we talked about today, we've only got, you know, 300 unique prescribers, so we have a long way to go. I think that's great news, right?
Liz Barrett
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. 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. You know, absolutely we have a long way to go. We're just in the very early stages of where we wanna be with penetration among docs. Long way to go. Very early in the early stages.
Leland Gershell
Great. Thanks very much.
Liz Barrett
All right. Thanks, Leland.
Operator
Thank you. I am showing no further questions.
Liz Barrett
Okay, great.
Operator
This concludes.
Liz Barrett
Yeah.
Operator
This concludes the question and answer session. I would now like to turn it back to Liz Barrett for closing remarks.
Liz Barrett
Thanks, and 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. Thanks for all the support. Happy to continue to share progress as we, you know, get into Q2 and beyond. Thanks again for everybody's support, and we will talk to you guys soon. You can disconnect now, operator.
Transcript from May 6, 2026
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