UroGen Pharma Ltd. ($URGN)

Thanks for joining the session with UroGen Pharma. My name is Alec Stranahan. I cover SMID Biotech here at Bank of America, and I have the pleasure of introducing Liz Barrett, the President and CEO of UroGen. Thanks for being here, Liz.

Thanks for having us.

Yes. Looking forward to the discussion. Maybe since it's a shorter 15-minute one, we can just jump right in. So you reported 1Q ZUSDURI revenue of about $30 million. That's more than 100% quarter-over-quarter growth. Obviously, still early days in the launch, but maybe you can just walk us through how that launch has been tracking versus your internal metrics.

No. Look, we're very excited about the results from Q1, but more excited about even more patients having access to the drug going forward. We talked often about the J-code, and I think some of us, including myself, wasn't expecting it to be as hard as it was prior to getting the permanent J-code. But practices are really concerned about reimbursement. So we absolutely saw the inflection as soon as we got that J-code. So we started seeing it in January. By February, we had already surpassed JELMYTO in doses, and then we just continued to go from there. So really pleased with where we are, looking at sort of our top 250 accounts, looking at penetration where we are. But importantly, what we're really seeing is some doctors who adopt this for most of their patients. And that's, I think, something that we will look forward to, but they really buy into the new approach of treating these patients differently. And we are seeing them treat patients across the continuum of care. And so it's a very exciting time for us, as you can imagine. And we expect to continue to see linear growth quarter-over-quarter for the rest of 2026 and into 2027. So again, very exciting time.

Great. And I imagine that the early repeat adoption is only a positive speaking to the profile for ZUSDURI.

Yes, absolutely. A lot of physicians will say, I'm going to try it on one patient, going to see how it goes, make sure I get reimbursed. And when you see the repeat prescriber, you know that not only did they have a good experience, but the patient had a positive experience as well. And we're hearing, of course, a lot of it anecdotal feedback, but hearing a lot of physicians, even surprised sometimes at getting a CR in some very, very difficult to treat patients.

Okay. And you mentioned the J-code as being kind of a -- maybe watershed is not the right term, but it's definitely -- it unlocks a door for the rollout. Do you see this as benefiting the academic setting or the community setting? I think you said that you're approaching maybe a 50-50 hospital to community mix now, which is up from 60-40, I think, in 4Q. So how does the community adoption ramp? I know that this is maybe 70% or so for the market?

Yes, absolutely. I mean most patients, particularly with the low-grade non-muscle invasive bladder cancer are seen in the community. So getting to the community practice, getting the community practice to adopt is very important. Those were the physicians that were very gun-shy with the J-code. The academic centers, you have the P&T Committee you have to go through. So there were some barriers there. But as far as they don't look at it from a financial standpoint as much as community practices do because if they just don't get reimbursed for one patient, it's a big deal. So now that we have reimbursement, but more importantly, that it fits into the way that they practice. So having intravesical therapy, they're used to intravesical therapy. They do it in other ways. And so it really fits into their practice. It fits into the way that they treat patients and it's economically beneficial for them. So once they get again over that hump, you'll start to see more and more community. So we expect -- I don't think even though 70% of patients are seen there, I expect that they -- ultimately, 65% of the revenue will come from the community practices.

Right. From a patient convenience perspective, you want to treat them where they are.

Sure. Absolutely. And look, the doctor also doesn't want to lose the patient. So they don't want to send them to the hospital. They want to keep that patient and the way they do that is by treating them in their office.

That makes sense. I guess when you think about the total addressable market, I think there's some publications out there that estimate maybe 85,000 annual patients roughly in this setting. You mentioned the physician feedback and getting CRs in patients that even the treating physician didn't think that they'd be able to get to that point. So do you sort of see this addressable market expanding? Or is that more of like a percentage applicable within that?

I think it's more of a percentage applicable because, again, like what typically happens in oncology drugs, you always use the new drug in your hardest patient first. And -- because they unfortunately have gone through a lot of other treatments and haven't had much success. And so that's, I think, why we're seeing some of these, but it's very, for me, heartwarming to hear about these patients, again, that have had such a difficult time for many, many years. And then they come, they do 6 weekly doses. They can get up and go home after. There's no real barrier to them going about their daily life and then they come back and they've gotten a complete response. So both from a patient perspective and a physician perspective, that's what has to happen for a doctor to further adopt it. And then they'll move it up in the continuum. In our study, most of the patients had only had 1 or 2 recurrences. So we expect that as the drug gets adopted more broadly, you'll move up in the continuum of care.

Okay. And we've talked about kind of the demand components from the patient and then the prescriber. How has payer access and reimbursement sort of trended?

The good news is we have 95% open access for reimbursement. Knock on wood, we haven't had any denials yet. So we're really, really pleased that everyone has been able to get reimbursed. Some payers take longer than others, sometimes the paperworks. But once you get all of that -- through all of that, we've had very positive reimbursement. And so again, as physicians start to see that, the practices start to see that, we have a team that works with practices if there are issues to ensure we have field reimbursement managers. We have a hub to ensure that they get all of the service that they need to help them, again, remove any barrier that they might have for -- to be able to use this in patients. And we are starting to also hear about patients walking in and asking the doctor for the drug. And we've just started to do more engagement with patients, believing that will be a big driver for us going forward.

Okay. That's great. And I imagine when you set the price, you had already approached in terms of cost benefit with all these...

Absolutely. No, absolutely. And our price, particularly when you compare it to the high grade, we are -- our drug is for the low-grade patients. So we price appropriately for that market as we have the low-grade IR. So we feel really good about our pricing. We feel really good about reimbursement. And so really, it's just a matter of physicians trying it and getting a positive experience.

Okay. And whenever we think about new oncology launches, we think about the on rate, but also the duration on therapy. This morning, I think you had a press release talking about 36-month follow-up from the ENVISION trial. I think it was 64.5% of patients had a 36-month duration of response. Maybe you could just speak to how this evolving data set is favorable in your view and how this kind of feeds into your communication with prescribers?

Well, we were thrilled to be able to share that data. What it says, and we have to keep in mind that the low-grade intermediate risk patient is all about recurrence. These patients recur. In our own ATLAS study, the median time to recurrence in the TURBT alone arm was 9 months. So we now are past 36 months, and we still haven't reached the median. So with 6 weekly doses of ZUSDURI, we believe that the median will be close to where we are with JELMYTO, which is about 4 years. So if you think about it, again, from a patient perspective, you have -- that's why we often talk about not only recurrence-free but treatment-free living because they can do the 6 doses, and again, the median hasn't been reached and it's been over 36 months. So we just recently got that data. I'm very, very thrilled to see the durability of response because that's really important for patients and patient care.

Yes. Yes, I imagine so. And this weekend is AUA.

Yes.

I imagine you guys are going to fly out to D.C. right after this.

We are.

Are you planning to host any panels? And I guess, how are you trying to use the conference to increase awareness? Obviously, there's already great awareness of ZUSDURI, but anything that we should expect coming up at AUA?

Yes. Look, it's a great opportunity to have a lot of key stakeholders in one place at one time. It's a busy, busy time. We have not only -- we're doing ad boards across our portfolio, but we are hosting an event on Sunday morning, specifically around ZUSDURI and Dr. Schoenberg, our Chief Medical Officer, will interview physicians who have used it. And we also were really thrilled that we're also going to have a patient who's flying out from California, and we'll be able to talk to her as well. And that will be webcast. So we're excited about that. Dr. Schoenberg will also present on Monday morning our 24-month data, which is kind of interesting because now we have 36 months, so he'll be able to put a plug in for our 36-month data. But we importantly want to spend the time making sure that any physician who has questions are those that are thinking about ZUSDURI, are JELMYTO, but maybe aren't quite over the hump. It's a good opportunity for people like myself and Mark and Mike, our Chief Development Officer, to be able to engage one-on-one with these doctors. And I myself have a lot of meetings over the next -- over the 3 days, but we're really trying to get to ensuring that we understand if there are any barriers to using our medicines, what are they and what can we do to overcome them because we want to make sure that every patient that can benefit from our medicines has the opportunity to benefit.

Great. Yes, we'll definitely be tuning into the webcast. I do want to ask about your -- the pipeline. I'm sure you get a lot of focus on ZUSDURI, but I think we should shine a light on -- you've got 103, which is your next-generation mitomycin formulation, streamlined reconstitution process, patents out into the 2040s. Maybe you can just speak at a high level to what you're seeing in the Phase III UTOPIA trial.

Yes. What we're seeing in the UTOPIA trial is very consistent data to what we see in ZUSDURI. And that's what's most important, right? When we worked with the FDA, initially, they said we couldn't do a bridging study. You actually have to do a patient study because the drug is a different drug. And luckily, what we've seen so far has been very consistent, and that's what we want to see. The other good news about having the patent extended is we have a lot of aspirations for moving UGN-103 into other patient populations with bladder cancer. So we are going to -- we're moving very quickly into high grade. We're also going to do an adjuvant study. And so we're looking at being able to cover patients, again, not just in the IR space that we have today, but also in other spaces as well. And then 104, UGN-104 for UTUC, upper tract, same thing. We expect to finish enrollment this year. And the thing I think what we're most excited about is our oncolytic virus. It's early, and we actually are going to first-in-human this year. But we really believe based on the preclinical data and the experiments that we've been doing that we have a truly differentiated and potentially best-in-class molecule. And so that's exciting for us because not just will it be best-in-class in bladder cancer, but it gives our company the opportunity to actually move outside of bladder cancer and outside of urothelial cancers because that oncolytic virus can work across many cancers.

Okay. Very good. Maybe talking about the expansion opportunity beyond low grade for 103. I guess, how are you thinking about moving up the spectrum and adding different sleeves of patients within NMIBC?

Yes. I think, obviously, there's a lot. It's a fairly crowded market, but unfortunately, these patients aren't cured. And every -- there's no drug that's perfect, right? So we actually believe that given the results that we've seen in the low-grade intermediate risk patient that we believe it will also work very well in the high-grade patient. Now the difference is it will be an adjuvant. The difference it will be maintenance therapy because these patients are at a higher risk for mortality, they're at a higher risk for moving to metastatic disease. So we would treat those patients longer. But we definitely believe and we have seen so far that it works in -- with bladder cancer, and we expect it to work across the spectrum. So we're finalizing right now exactly what the patient population will look like and what our control will look like because it will be a comparative study. But we could go into BCG-naive and the BCG-unresponsive, those -- so a lot of different spaces to go into there and still a very high unmet need despite the fact that others are in that space.

Okay. And I guess you have some experience from the ATLAS study. Is that right?

Well, the ATLAS study was also in low-grade IR as well. So that was -- it was in that study as well.

Okay. So at least comparing against...

Exactly. The TURBT. Yes, absolutely.

Okay. Maybe we can talk about 501, too. How is this maybe symbolic of how you imagine the company growing beyond sort of your current...

Well, I think that everyone -- UroGen has been around and we've had JELMYTO and we've had ZUSDURI, right? And that's been kind of the focus externally and internally for a long time. But we have aspirations to be a leader in urothelial and specialty cancers. And we believe 501 gives us that opportunity. Again, it's an oncolytic virus that's differentiated. It not only works in the immune system, but it has direct cancer kill. We believe we actually can put it in our gel and maybe even see better efficacy and that we know based off of the work that IconOVir did before we acquired it, that it works in other cancers as well. So that's why we believe that 501 is a catalyst that will bring our company from just being a leader in urothelial cancers to expanding beyond and diversifying outside of urothelial cancers.

Okay. Very good. Lots of exciting things going on at UroGen. But unfortunately, we'll have to leave it there. So please join me in thanking Liz for the great conversation.

Thank you, Alec. Appreciate it.