URGN - NASDAQ

Good day, and thank you for standing by. Welcome to the UroGen Pharma Second Quarter 2025 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's Second Quarter 2025 Financial Results and Business Update Conference Call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30, 2025. The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to JELMYTO and

Thank you, Vincent. On June 12, we achieved a defining milestone for UroGen with the FDA approval of

Thank you, Liz. As a practicing urologist, I've spent years managing patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We see the approval of

Thank you, Mark. As my colleagues have shared, we believe

Thank you, David. As Liz mentioned earlier, JELMYTO net product revenues were $24.2 million for the 3 months ended June 30, 2025, compared with $21.8 million in the same period in 2024. Year-over-year revenue growth of 11% was driven by underlying demand growth of 7% and price favorability as the gross to net rate for JELMYTO has stabilized in recent quarters. R&D expenses for the second quarter of 2025 were $18.9 million, including noncash share-based compensation expense of $0.4 million. This compares to $15.4 million, including noncash share-based compensation expense of $0.6 million for the same period in 2024. The increase in R&D expenses of $3.5 million was primarily driven by higher manufacturing costs for

[Operator Instructions] Our first question comes from Tara Bancroft with TD Cowen.

So I have to ask the obligatory first question on all of our minds. Is there anything that you can offer on metrics you've hit so far for July, like, I mean, script rate, number of active accounts or prescribers that you have, or really anything qualitative, like the perceived level of pent-up demand from those who were maybe waiting to get a TURBT to instead receive

Yes. A great question, Tara. It's Liz. And I'm going to ask David to comment, and then I'll probably add some color as well. So David?

Yes. Thanks for the question. We're really excited by the positive receptivity of not only the health care providers that we have engaged, but also the payer community. As we heard prior to launch, they're very eager for a new treatment option, and they took on the

Yes. Tara, look, I'll give you a little bit more color on that. One, we're not going to give metrics at this point. I'm sure everybody would love to have them, but it's still very early for us. What I will tell you is that we've all been spending a lot of time out in the field and talking to doctors. And to David's point, there's a lot of excitement. And what you hear from doctors is they all have patients. And I want to sort of put a note on patients, because when we launched JELMYTO, it's like I have a patient. And when we talk to doctors today, they have several patients. The biggest hurdle, frankly, is reimbursement, which we knew that. I can tell you that I went to an event last week with a lot of community practices and doctors and the first thing they say is, as soon as you get a permanent J-code -- soon as you get a permanent J-code, I've got patients waiting. We don't and we've always said there would not be a bolus of patients. But again, what I can tell you is that our PEFs are coming in, patient enrollment forms. So the top of the funnel, we're very happy with where we're going there. And the team, as David said, is working on the sites of care, pulling those through and dosing -- really getting patients dosed. So I would say at this point, we're very optimistic. We feel really good about where we are. We think the consensus, as we said for the year, we are still aligned with that and have the opportunity to see some real uptake over the next few months. I do think David commented this in the prepared remarks that you will see an acceleration after the first of the year when we have the J-code. But we have hospitals, we have institutions and we've got some large practices that are all willing to write. So it's not like no one is willing to take -- to do it during the miscellaneous code. But you do see a big difference in sort of attitude kind of before and after. But the good news is, is that all of the metrics, the feedback we're getting –- I have not talked to one doctor who said, no, I don't see a role for this. And none of them, frankly, that say they're going to really limit it. So again, a lot of excitement around using this in multiple patients in their practice. So hopefully, that extra color helps without giving very specific numbers for you. But David also mentioned sites of care. We have set up a lot of sites of care, and we're on track with where we need to be in the number of sites of care that we already have set up so far to deliver what we've stated we would deliver for the year. So hopefully, that helps.

Our next question comes from Michael Schmidt with Guggenheim.

Perhaps a follow-up just on the early launch. Yes, we've certainly had some very positive feedback from urologists as well that we spoke with in terms of intent to prescribe the therapy. But just curious what you're seeing so far around the reimbursement process early on using the miscellaneous codes. Just curious if you could comment perhaps how much time it takes in terms of intent to prescribe until sort of conversion to paid prescription? Or anything along those lines would be helpful. And then I had a follow-up.

Yes, sure. Go ahead, David.

Yes. I'll just comment on the initial process in terms of educating accounts. So as we discussed in our prepared remarks, we are really focused on a group of around 2,000 providers that have demonstrated a willingness to adopt product during this particular period. And so that's pretty much what we're seeing in terms of interest right there. One of the things we do, which is very similar to what we did with JELMYTO at that launch, is we spend a good amount of time educating them on the actual process for claims and billing and then reimbursement. So we educate them fully on that. So it's white glove service. And with that, they have the reassurance of knowing they've -- when they enroll a patient, they know what that patient's co-pay is going to be, they know what the coverage is going to be, and the office feels more reaffirmed in terms of how that process is going to work. As you know, with the miscellaneous J-code period, it is a little bit of a different process because it's manual. But what we're seeing so far is that when we engage the practices, they feel assured that what they're doing is setting them up for a positive experience.

But too early to give -- too early -- so we haven't had any "paid claims yet." So it's too early to sort of say how long is it going to take. As we start to see that coming through, we'll be able to give you more color on that. But it's too early to see that.

Right. And then I guess if you were to compare the initial experience of the

Yes. Since Mark and I were the only 2 people here when we launched JELMYTO, I'll give you some comment and ask Mark to add anything. I think the –- it's similar in a lot of ways in the sense of what you have to deal with, with the J-code, what you have to deal with reimbursement, what you have to deal with identifying patients, and what you have to deal with, frankly, for an office to get set up, set up with the distributor. The good news is, obviously, a lot of these offices are already set up. So all we have to do is add in

Yes. Thanks, Liz. So it's, I think, obvious to many on the call that we're dealing with a completely different demographic, so to speak, a demographic opportunity. Upper tract urothelial carcinoma, the target of JELMYTO use, is a very small population of patients. And on average, most practicing urologists will see 1 or 2 patients a year. So it's hard to find the patients and it's hard to find individuals to treat with JELMYTO, which I think explains a lot of the experience of why the JELMYTO ramp has been what it has been. That's very different than what we're dealing with, with the

Let's just squeeze one more in, and this one is on UGN-103. And so now with the UTOPIA study fully enrolled, I was just curious if you had the chance to have any additional discussions with the regulators in terms of -- sort of coming off of the panel earlier this year in terms of whether the study is, in fact, supportive of potential approval? And from a clinical perspective, is the goal to essentially reproduce the ENVISION data? Or is there opportunity to differentiate clinically with 103?

Yes. No, a great question. We have not interacted. It's -- we don't have enough data yet. So we're waiting on additional data before we interact with the FDA. But we will absolutely do that and have feedback for you prior to the end of this year. So I think that's the timing on that. The goal is to replicate. And we actually purposely did that because what we didn't want to do is introduce any potential issues, right, that would muddy the waters as far as the data is concerned. So we tried to replicate almost exactly the ENVISION study. So there -- unfortunately, there's no differentiation. But fortunately, what we're doing is trying not to introduce any biases. Our expectation is that the FDA will accept the study as they had previously communicated, mainly because this is a new formulation. And they actually have UGN-102,

Our next question comes from Leland Gershell with Oppenheimer.

A few from us. With respect to the first phase of the launch pre the J-code assignment, I'm wondering, as you're going after those 2,000 docs you've identified as early adopters, can you share what -- how those break down with respect to community versus academic docs? Should we think of the academic -- those who practice in an academic setting as maybe having easier access to the medication? Is the miscellaneous J-code easier in the hospital setting or through that process? Is there a P&T committee dynamic that we should consider for

Yes, absolutely. David?

Yes. The majority of that 2,000 physician, I'll say, early adopter list that we've identified reside in the community, and there are some in institutional settings. And as you know, some have privileges in hospitals as well. So when we think about them gaining access to

Okay. Great. And then just another question with respect to the UTOPIA trial. Do you think the FDA would ask for longer durability data or anything that may be incremental to what was shown with ENVISION? Or do you think it truly would be kind of a replicate of the ENVISION data set that could get 103 approved?

Yes, we are expecting it to be similar to what we presented for ENVISION. We're going to talk to the FDA about their expectations. But our expectation is that it would be -- it would mirror similar types of requirements as ENVISION, namely concentrating on CR with some reasonable amount of durability data. And that would obviously be something that we have to talk to the agency about.

Our next question comes from Raghuram Selvaraju with H.C. Wainwright & Company.

Congratulations on all the progress so far. I wanted to ask, first of all, about clarification of a couple of commercial things. Firstly, you alluded to once the formal J-code designation is complete at the beginning of next year that there would be outreach facilitated by this to a broader group of prescribers. Can you maybe quantify for us how many more prescribers are likely to be targetable beyond the initial 2,000? And then also, I wanted to ask if you are seeing any evidence that the commercial availability of

Yes. David?

So on your question around how we're going to engage the total universe. So as we said, we are focused on the 2,000 that we think are very important to the early stages of a launch. It doesn't mean that we won't see others in the universe if they're in the same office. But broadly speaking, as we turn the corner into 2026, we will expand our efforts beyond that 2,000 and we'll begin very rapidly then expanding our reach to a greater number of them. So I would say by the middle of next year, we're going to see -- we're going to be broadly engaging everyone in that total universe. And keep in mind that universe also includes -- in each office, there's physician assistants, there's nurses. So our efforts go well beyond just the HCP. With regard to your question on JELMYTO, it's too early to say that. But what I can tell you what we've observed so far is that, as Liz mentioned, those who have used JELMYTO definitely understand the technology behind

Great. And then just one follow-up with respect to UGN-103. I was wondering if at this juncture, you have any reason to believe that because of the characteristics of the new formulation, 103 might have advantages in safety, tolerability or ease of administration relative to

The answer is we don't, and we didn't expect any real changes. For the audience, just to remind you, the principal issues related to this formulation relate to solubility, ease of reconstitution related to a change in the excipients of the preparation. But we don't expect a change in terms of the clinical profile, and it's premature for us to talk further about that, and we will be happy to share those data when we have them later in the year.

[Operator Instructions] Our next question comes from Paul Choi with Goldman Sachs.

I also want to follow up on UTOPIA and maybe ask, is there anything in terms of either the data or product profile that you might call out that would allow you to address additional segments of the low-grade intermediate risk population that you feel like you can't currently tap with

Go ahead, Mark. Do you want to answer the UTOPIA question? Are there any...

Yes, sure. So the answer to the first question is no. As Liz mentioned, we are really formatting the evaluation of 103 in the UTOPIA trial in exactly the same manner as we did

Yes. But as I mentioned earlier, we absolutely expect to expand UGN-103 into other patient populations, but not because it's different than

Yes. So on the question of

And we are engaging all people in the practice, right, everybody from physicians to your PAs to your -- the reimbursement team. So from that perspective, included in the 8,500 targets are other targets outside of physicians. So we'll continue to do that. This is a full –- a comprehensive account sell. It needs to be. But in the beginning, clearly, the physicians' conviction around wanting to use it is going to drive the early adoption.

Our next question comes from Aydin Huseynov with Ladenburg.

Congrats on the quarter. A good couple of questions I want to ask. So first, I wanted to ask that if there were not questions about permanent J-code, if we didn't have issues with J-code this year, permanent J-code this year, how many patients do you think it would be possible for you to dose in 2025? So the reason I'm asking because ENVISION trial enrolled very quickly, I think, 220 patients, 10 months across 90 sites. I was trying to understand if we did not have reimbursement issues at this point, so how many patients would it be possible to dose in 2025?

Yes. Look, that's a great question, not one that we're going to speculate on. But suffice to say that absolutely it's a significant number of patients. As I mentioned earlier, the #1 barrier right now is reimbursement. It's not around the desire for clinical use. And that's a good thing. That's a really good thing. I mean, rarely do you roll out where there's not question -- more questions around the clinical data, the clinical use, the patient identification, and we're not hearing that. The only -- again, in all the conversations I've had, it's only been around reimbursement. So that's actually a good thing, because we can solve that, right? It takes time to solve that. But once we start getting explanation of benefits, EOVs out there, once they start to see what we're hearing from a lot of the practices, is, okay, I'll try it on one patient. They typically want it to be a Medicare fee-for-service patient, because that's kind of the one that they feel most confident about. And then once they get that experience and see a positive reimbursement, then they're more willing to expand beyond to other patients. But I think, again, without speculating on the number, it would be significantly more. There's no doubt about it. And I think the good news is when you're out there talking to doctors, that's the question. It's really around reimbursement and not around the clinical usage or utility or need for this drug. And I think that's a very good place for us to be.

When do you think you'd be able to provide short-term and long-term guidance for

Yes. Aydin, this is Chris. I mean I think we've been pretty clear in terms of peak potential. We view

This concludes the question-and-answer session. I would now like to turn it back to Liz Barrett for closing remarks.

Yes. I just want to take an opportunity to say thank you to everybody. Thanks for hanging in there with us over the years. It's an exciting time for us. We're still in the early days, but things are looking great and we're very excited about kind of where we are and where we head to be. And we'll keep you guys posted as things play out. So thanks a lot. We appreciate it. Operator, you can disconnect at this moment. Thank you.