UroGen Pharma Ltd. (URGN) September 2026 Conference Transcript

Hello, everyone. My name is Mitchell Gafoor. I'm a senior biotech analyst at H.C. Wainwright. It's my pleasure today to welcome you to the Urogen Fireside Chat. Today, I have the pleasure of welcoming Liz and Chris from the company. Thank you so much for joining us today.

Thanks for having us. We appreciate it.

Thanks, Mitchell.

So maybe, you know, I like to start off every fireside by just recapping the company a bit, the key priorities and what investors should should think about um about urogen if they're not familiar with the story or up to speed yes um i think the we have to take a two minute you know back going going back our company was founded uh many years ago in israel by a group of chemists who were trying to answer a challenge that urologists have and urologists treat cancers locally. So they give intravascular therapy rather than systemic therapy. Somebody was just calling it cancer light. But anyway, and so because of that, medicines in the urethelium can't really stay long enough to have a meaningful impact for patients. And so therefore, these patients really, standard of care is multiple surgeries time after time again, particularly in the group of patients that we have. So this group of chemists developed a very elegant solution called RT gel and it's called RT gel. It's reverse thermal gel where it's actually liquid when it's warm which is why it's called reverse thermal. I mean liquid when it's cold and as it hits the warm temperature of the body turns to a gel and then over time you know disintegrates and elutes medicine out to the cavity. In our case, the upper track or the bladder. And that's what our company was really founded on. And you talked about, you know, what are our priorities? Obviously, right now, we got approval for Zesturi, which is for a low-grade intermediate risk, non-muscle invasive bladder cancer. And our launch right now is our number one priority. We have to make sure we continue to accelerate and grow that business, not just for our company, but for patients, because we really feel very strongly that this is a better way to treat these patients. They're an older patient population, and our data shows very meaningful, complete response and durability. So these patients have an opportunity to not only live recurrence-free, but live treatment-free and not have to worry about these sort of, you know, multiple, multiple surgeries. So that's our company. We, in addition to where we are today with our, you know, two products that we have on the market, we have lifecycle management that we're working on to, we'll take UGN 103 into other bladder cancer spaces. We have an onculating virus in UGN 501. We also did a, recently did a deal with a company called Intrigel. And so, you know, we're really building our company for the long term.

Wonderful. That's a great place to start. So speaking of the launch, you're in the early days and that's a priority, as you mentioned. Can you just kind of help us understand how that's going? The story grew 73% sequentially to 50.4 million. What's driving the quarter and how much of that step up was underlying demand versus net pricing, channel inventory. And just understand, like, help us understand what's the receptivity been like.

Sure. So I'll ask Chris to sort of comment and then I'll add any.

Yeah. So just to answer your last question first, you know, in terms of, you know, what's driving it is all demand. So, you know, just given the nature of our products, it's a buy and build drug. So physicians acquire the product and then instill in the patient we really don't have inventory dynamics with the way the drug is is distributed and we really have had consistency in terms of gross to net so it is truly demand that you're seeing reflected in the revenue in terms of what's driving the launch you know one we received the permanent j code effective january 1st so that was definitely an inflection to give the physician community confidence in the reimbursement of the drug um but more importantly you know we're we're very much in the early stages of this launch it is a large unmet need there's 60 000 patients in this population from a physician perspective our broad target universe is about 8 000 physicians our core target universe is about 6 500 and in that 50 million of revenue only 450 of those physicians have prescribed uh launched to date and so there is a lot of room for us to grow first just in terms of breadth of utilization across the physician community and then importantly you we're finding is physicians who use it and try it you know we recently did an atu 100 of the physicians have used the drugs and they will use it again and so the other piece that we've been really focused on beyond the breath is really driving depth of utilization so really encouraged by the fact that 45 of our prescribers are repeat prescribers they've treated you know more than one patient so again we're in the early stages but really pleased with the early trajectory this year.

Excellent. So on that note, you know, 204 repeat prescribers and, you know, about half. Can you tell us, like, what's resonating with them? You know, how can that grow? And what do these launch metrics kind of say about the repeat rate and the trajectory of the drug?

Yeah, I'll just sort of start there. The feedback that we're getting from physicians is that this is easy to use. And they are seeing in their own experience the success with their patients. And that's important, right? Because what happens is you get them to try it. Initially, they're all trying it and you're harder to treat patients. So they're seeing a benefit in their hardest to treat patients, kind of a light bulb goes off, right? It's like, oh, this is great because, you know, it's really working, you know, in this patient population. So the durability of response, we just announced in May that we had 36-month durability of Sesturi and still haven't reached the median. So when you think about it, that about 50% of these patients would have recurred with a surgery within the first year and now all of a sudden we're past 36 months and they haven't hit the median so those are the things that are really resonating with physicians but getting experience nothing you know beats that nothing beats that so you know we have a lot of physicians as you know chris mentioned early stages a lot of physicians that want to use it and say they're going to use it and we just have to get them to use it on those first patients have a good experience we're really focused on making sure they have a very good first you know positive experience and um and then to chris's point build that depth but reality of it is is that you've got everybody from doctors who have decided this is the way i'm going to treat my patients and they treat almost all their patients that way you know and then you've got some that say well i'm only going to use it for those patient you know patients who i can't take to surgery because you're, you're, you're changing the way doctors practice medicine. And I don't think you can underscore how hard that, you know, is particularly with urologists who are surgeons. So you're telling them, don't do surgery anymore, do this instead of surgery. And, but the receptivity, you know, has been, you know, really, really good. And we feel, as Chris mentioned, we feel great about kind of where we're headed because we know that as they are getting experience and they're able to share that experience, that, you know, that more and more doctors would use it.

So repeat prescribers are certainly an encouraging metric. How many patients does a repeat prescriber treat? And what would you say that trajectory would look like? Is it, you know, a situation where the initial repeat prescribers, they're starting and just trying it in a few other patients and you expect that to grow, the patients per repeat prescriber? or how does that change and how does that, you know, eventually level off?

Yeah, I think within that repeat prescriber base, Mitchell, there's a pretty wide swath. I mean, at this point, there are some real early adopters who are using Systoria for the majority of their patients. So they're looking at a low-grade IR patient and saying, I'm going to start with Systoria. There are others who are just in that early stage of evolution in terms of repeat use. So they, you know, they'll try it on one or two patients. They want to get experience with the drug. how do I incorporate it into my workflows, make sure I get reimbursement, understand that, you know, how, you know, from a patient outcome perspective, and then they start to move along the continuum. And so, you know, we have a relatively wide range there. In terms of how that adoption rate, you know, will evolve over time, that is a metric that we're really looking at.

And I think to see steady improvement, not only in the number of prescribers, but also the percentage of those prescribers that are repeat prescribers anticipating that that 45 percent repeat you know uh rate in q2 will continue to improve as we uh you know move through the year and i think one more sort of metric that we um we in our we did some claims database research the good news is it shows that they're not just now treating their heavily pretreated patients so they're treating as you know chris alluded to the some of the physicians after one after two you know, yeah, after five, after six, but we're getting the all patient populations and not just you're heavily pretreated. So that talks about somebody who's clearly a champion of, and that's what we are focused on. Like, how do you build those champions? How do you take those that are early in the adoption and make them true adopters to your point about the number of patients that they have. To kind of contrast it against Jalmito, where you have 6,000 patients that are seen by 10,000 docs, so it's very hard to find those patients. Doctors see these patients every day, and so that makes it much easier for them, but also much easier for us in the sense of being able to find the patient.

That's a great segue into this. I'm curious. It's an interesting dynamic where you know 70 of the patients are in the community setting um so your initial uptake and your initial kind of experience you know can you help us understand where that's been in terms of academic versus community how you expect that to change and what's what's going to drive growth in terms of accessing these patients how broad the community is um you know chair time buy and bill, all these dynamics that may influence how we can think about the launch.

Sure.

Some of our early champions were in the large academic settings. And the other piece you mentioned was the reimbursement component. So during the period last year with the miscellaneous J code, community practices are a little bit cautious about using a drug during the miscellaneous J code, where hospitals are less concerned. And so what we found was, you know, the majority of our business last year, about 60 percent of our business was in the hospital academic setting last year. Once we got the permanent J code effective January 1, we quickly started to see that business shift and the community practice has really started to open up and started to use. And so to your point, 70 percent of the patients are in the community practice. So where we expect to really see the business start to move and where we've seen a lot of the increase in terms of prescriber rates, adopters in the community practices where we're seeing it this year. And so we just think about where the business shift is 60 percent was in hospital last year in Q2 was already 55 percent in the community. And we expect that that number to continue to increase, maybe not all the way to that 70 percent number, but, you know, closer probably to 65 percent. that people are there any differences you would expect um in terms of the launch metrics and uh utilization once more of that use migrates to the community setting versus where you're seeing this initial well i think the biggest thing is the prescriber base right i mean that there's a a lot of opportunity in the community setting to really expand that prescriber base and with that as they start to adopt it in their workflows repeat writers in the community is something that we're also focused on. And the other thing we talked about, or we had talked about was conversion from a patient being identified to a patient being instilled. So it goes back to the operational component of this launch. And so initially it takes a little bit of time to get the sites up and running, to get them through the buy and build process, to get patients set up. But once they've done it with one patient, they move more quickly. So I think as more physicians get experienced, more practices get experienced with adopting this infant workflow those conversion rates and time to conversion are going to improve okay great and what would you need to see uh stabilize in the launch or how far into the launch do you feel you would need to get uh before you can provide some formal guidance and outlook for the yeah we want to get at least through a full year with the permanent j code in place to really understand you know what is the trajectory or what type of inflection are we going to see with the J-code, and importantly as well, just, you know, how do the quarter to quarters, how the variability could we see within the quarters? So I think, you know, the earliest we would consider, you know, providing guidance would be, you know, looking at it for 2027.

Great. Okay. And just want to touch on Jelmaido. Maybe you could help us understand kind of the trajectory there, the second half acceleration, and what we should think about with the 2030 erosion.

Yeah, the Jalmito, you know, as I mentioned earlier, in contrast, is a very small patient population. We always struggle with identifying patients. That is the number one challenge with Jalmito. But, you know, it's a great drug. We expect to continue to see, you know, low single-digit growth year over year. One of the things that's been challenging this year for us has been, well, obviously the focus has been on Susturi and the Susturi launch, but more importantly is there, it's actually, given it's a small market, there are a lot of clinical trials happening, and particularly in the United States. And so what we have found is that for a few million dollars of our revenue that probably would have been in gel mito is going to clinical trials. And so, again, that space has been just very busy. And so we're always looking at, okay, that, you know, that dynamic. But if you took that dynamic out, then we would be kind of on track with where we are. So a lot depends on kind of how those clinical trials play out. But our intention, you know, is to continue to grow gel mito. And actually we really believe that in the longer term, because we're calling them more docs than when they get experienced with the story. They're like, oh, I like the way the story works. And now I might use it in gel mito. So those kind of onesies, twosies, that's the biggest problem is the doctor isn't thinking about gel mito, right? Because they only see one or two of these patients a year. But maybe if we're there with just Dury, they'll start to see that. And so we're hoping, you know, at some point that starts to have kind of a reverse halo. But right now, again, one of our biggest challenges is really just clinical trials, you know, competition for clinical trials in this space. But we're still seeing some good, you know, good adoption of Jomaito in our current base, as well as we continue to see new physicians writing for Jomaito.

Great. Okay. Right. And on UGN 104, can you help us with the timing of that and when it will be submitted, potentially approved? And would you think about, you know, the same transition book, playbook you're using for 103 and Sustury?

Yep. Absolutely the same playbook. We expect to be fully enrolled in the trial this year, which means we would file. The good news is that the FDA is allowing us to file on six months' data with 103. three, we already filed, as you know, we expect the same thing with UGM 104, and then we update it during the filing. So given that, then our expectation would be we would file in, you know, early 29 and get approval by the end of 29 and do that shift, as we talked about with Jalmito 104, just as we are with Zesturi and UGM 103. And I think, look, the big difference today is we just received notice of allowance of a new patent on Sesturia and UGM-103 to 2044. So there's not any pressure for us to make that switch, but we still think it's the right thing to do for the business and it's the right thing to do for patients from an insuring supply perspective, the consistency of manufacturing, the solubility, making it easier to reconstitute, and it's got a longer shelf life. So all of those things for UGN 103 and then subsequently for UGN 104 will help just in the operational aspects of the products.

Great, okay. And on the UGN 103 switch, how do you manage the switch to 103 pricing relative to the risk of a J-code gap at launch and cost benefit from manufacturing? one, we will not launch until we have a J code.

So there won't be, well, we will not, you know, launch EGM 103 until we have a permanent J code. Like I said, there's no, there's no real reason to do so. And we want to make sure that we don't, that doesn't happen. The switch, I think because we have specialty distributors and specialty pharmacy will likely be easier than it would be if you had a drug that patients were going to go and get at the, you know, the pharmacy. So you, you know, you still have a fairly easy, you know, group of physicians and practices that will go through these distributors, and that will make the switch a little bit easier. So look, we are going to do what's in the best interest of the patients and the physicians to ensure that they can get the drug. But, you know, either one, we just want to make sure that they get, they can get treated. So we'll have both of them on long enough to make that happen. But at some point, you're going to have to make the switch. And we think that we can manage that pretty easily.

Jumping around a little bit, but I think this is important. Zesturi, could that potentially move into frontline at some point? And, you know, how would that look versus recurrent disease? How important is durability?

Yeah. The answer is yes, obviously. Our ATLAS data, we treated newly diagnosed patients. And the only reason we, in our pivotal study, that we didn't was based on the FDA feedback. They felt like the recurrent patient was the higher unmet need. And because we're a primary treatment and not an adjuvant treatment, we know that 90% of the patients are going to get a TRBT up front in the newly diagnosed. Having said that, so Mark, obviously, our chief medical officer, we are going to do a study, and that we will start early next year in the newly diagnosed segment. And that's in addition to a TRBT, because they need to do a TRBT for diagnostic purposes. So we will generate data in that patient population. So not really, so that you can use it, you can go back and look at our Atlas data, it works, you know, works well in that patient population. So there's no reason not to be able to use it. The real question does come, and when you're talking about a low-grade, even intermediate risk, what's in the best interest of the patient? And being able to have a surgery up front, and then when they recur, have the story, is in our estimation, in the best interest of the patient. It gives them the best, less treatment, but the best long-term impact. But we want to generate the data because we know if physicians do want to use it, we're happy for them to use it in that space.

Great. Okay. And then looking at 501 and the competitive landscape, could you help us understand what differentiates you guys from natto faragine and crestemagine? And what is the phase one design and timing of first efficacy for 501?

Yeah. So Eugene 501 remembers in phase one, which is a safety study and a dose escalation. So we are starting that this year. As a matter of fact, we've already have some site activation. So we'll start to dose patients this year in that. And again, the idea is about dose finding. If there's an efficacy signal, we will report that as well. But the idea here is to get the phase two to study. What's really important about UGN501 and what makes it different is we believe it's the best in class because it has a dual mechanism in the sense of not only does it elicit the immune response, which you expect, right, from an oncolytic virus, but it also has direct cell kill. So it enters the cells easier than some of the other. So it can enter more cells. It can actually directly kill the cells. And as it kills those cells, elicits the immune response. So we believe even our preclinical models, where we compared it to others, you know, obviously we have to demonstrate that in the real-world setting, but it was the most potent of the onculated viruses. So we're very excited about it, and also UGN501 is a good bridge for us outside of urothelial cancers. But UGN501, there's no reason why you can't use it across most cancers. And so we will be looking next year to do a basket study in multiple solid tumors with UGN501. So, you know, as we build our company again for the long term, not only are we going to ensure our leadership in urethelial cancers, but also start to look at opportunities outside of urethelial cancers.

Wonderful. With so much going on, I would love to wrap up with kind of the next 12 months ahead. What milestones should we look forward to and the value inflection points for the company?

Yeah, I mean, obviously a big focus that's going to continue to be as the story launch and how the quarters continue to trend and the growth of the brand. UGN 103, we will continue to follow the patients. We'll have 12-month durability of response data, likely towards the end of this year, early next. We'll use that to also supplement the data in the NDA and then ultimately looking to get a, you know, one of three approved, you know, PDUFA date in the June timeframe next year. And then as Liz mentioned, you know, really excited to get the 501 program up and running. So phase one start, you know, start to look at the data that comes from that over the course of next year.

Thank you, Liz. Thank you, Chris. Really appreciate it. And thank you to all the audience members in the room.

I appreciate it.