Good morning, everyone. I'm Tara Bancroft. I'm one of the Senior Biotech Analysts at TD Cowen. Thank you very much for joining our 7th Annual Oncology Innovation Summit. For the next session, we have a Q&A with UroGen. It's my pleasure to introduce Liz Barrett, the President and CEO, Chris Degnan, CFO, and Mark Schoenberg, the CMO. It's a privilege to have you all here, as always. Thank you very much for joining me. Before I get started on the Q&A, I just want to remind you in the audience that you can email me questions at any time at tara.bancroft@tdsecurities.com. I'll make sure to get them asked. Also, as you all may know, the Extel voting, it kicks off today. From myself and the TD Cowen biotech team as a whole, we would really appreciate your support if you feel like we have earned it, which of course, we truly hope that we have. With that aside, let's get into questions. I don't know, Liz, maybe you want to start with some high-level thoughts, and then we'll talk a little about ZUSDURI and the pipeline. Sure. Well, it's hard not to talk about AUA since we all just got back from the AUA conference. Yeah. A week or so ago. It was a great conference for us, and I think what it did would really solidify ZUSDURI as sort of the go-to in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. We're excited about that. If you were there at the meeting, and I know some investors were there and some analysts were there, you saw ZUSDURI all over the place. I think more importantly, we had an opportunity to spend time with physicians. A lot of physicians in the sense that we were getting feedback from them where they see not just ZUSDURI and JELMYTO, but to your point, our other programs in place, just talking to them about UroGen. It's a lot of excitement about the company right now. We're happy to be here, as always, Tara, and enjoy always our conversation. As do I. Okay. Let's start with ZUSDURI. You guys posted a great quarter, nearly $30 million. Maybe you could just start with reminding us from Q1, what can we expect from here? I know we went over these types of things a few weeks ago, but as we get every single week further into Q2, it'll be really helpful to hear what you guys are hearing, how that's evolving your expectations, not just for Q2, but for the year. What kind of growth can we expect from here? Sure. I'll ask Chris to sort of comment, and I'll add any commentary at the end. Sure. Maybe just reflect again just on Q1, to your point, Tara. Just as you folks may recall, we had $14 million in revenue for ZUSDURI in Q4 of last year. We did expect to see an inflection once the permanent J-code came into effect on January 1 of this year, and we absolutely saw that inflection. As we talked about Q1 performance, you mentioned over $29 million in Q1 revenue, so more than doubled our revenue quarter-over-quarter. Importantly, we saw acceleration across all of our key metrics that we're looking at. We exited last year with about 100 writers of ZUSDURI, and now we ended Q1 with over 250 writers. Importantly, we saw an acceleration in the number of adopters or repeat writers. Those who treated more than one patient with ZUSDURI. We went from 30 repeat writers at the end of last year to over 100 at the end of March. Really pleased to see not only the number of new writers, but the number of repeat writers just showing conviction in adopting ZUSDURI into their workflow. That led into additional patient enrollment forms, new patient starts, et cetera. Really pleased with the ramp in Q1. The other thing we mentioned in Q1 was it was a ramp. We didn't see a bolus. There wasn't a huge amount of patient warehousing or things of that nature, and we don't really have any type of inventory dynamics in our revenue. What we saw in Q1 was month-over-month growth. We also said that we did see that trend of month-over-month growth continue into Q2. What that gives us is confidence in durable revenue growth as we look at the rest of the year. We haven't provided guidance for the year, but what I would say is think about the growth more in a linear trend. We do expect to see continued growth throughout the year and beyond this year. Great. Okay. Maybe, I think one of the most helpful things is us to understand, on a larger scale, KOL or physician feedback that you're hearing, how that's evolved from prior to and following the permanent J-code. It helps us to understand the sentiment among physicians to use ZUSDURI or not. Yeah, what I'll say is that in all of the research that we've done, and in all of the anecdotal feedback in meetings, very positive feedback from physicians. The survey work we've done, 92% of physicians say that they will use ZUSDURI. I think what we see and what we hear is what I would characterize as a traditional adoption curve. What do I mean by that? What I mean by that is actually you already have some physicians that are already all the way to the right that say, "I'm going to use this in all of my patients." I'm not sure if anyone has listened to or saw the webcast that we did while we were at AUA. We had three users of ZUSDURI. Trust me, we didn't pick them based off of the fact that we knew they were going to say this. They all three said yes. When we asked the question, what percentage of your patients or which patients? There's not a patient that's a recurrent IR patient that they felt like they couldn't use it in. That was great to hear. We've already seen that. We have a couple of physicians that their conviction, they've adopted it. This is their standard of care. You have a few on the other side that say, "Yeah, I'm going to use it on my older, frail patient that I don't want to take to the operating room." Then you have everybody in the middle, right? It's our job, obviously, to move all of those along the continuum of adoption. If the feedback that we're getting so far has been very positive, and if that continues, we need both. Chris talked about repeat users. We are focused on both increasing the number of users and also increasing the depth of the users. We have some physicians that say, "I want to try it, see how it goes." We really talk to a lot of doctors that have used it, not on one patient, but on multiple patients. I think that that's also a big difference between JELMYTO and ZUSDURI, because it's really where are the patients? Where do you find them? Are they there? With JELMYTO, as we know, it's a rare disease. A lot of these doctors only see one or two patients a year. What we're hearing, and Mark can comment on that as well, because he talked about one of the big surprises that he's heard so far is physicians are sort of surprised at how many patients they have that they believe are eligible for ZUSDURI. We're hearing more and more about that. That gives us a lot of confidence in the durable growth that Chris talked about. I think we believe that we'll continue to see that, again, along a traditional continuum of adoption. Yeah. I will say that AUA webinar that you guys hosted, that was super well done and really helpful to have all of those KOLs there, but it was just well done. I felt like we were watching the morning show. Well, we appreciate that. We didn't do a whole lot of rehearsals around that, it's good when you have good people that are convicted... Yeah. ...that we had was amazing. She flew all the way from California, but because she was convicted. She had gone through a really difficult time, and she was so enthusiastic and happy with the result, but also, with the treatment compared to what she had been going through the last couple of years. Yeah. No, absolutely. Definitely the patient testimony was new information and also super helpful. Would you say that what you heard from the patient there, how representative of the patient population as a whole would you say that that experience was? Again, this is all anecdotal, but from what we're hearing... Yeah. ...very similar. I'm going to ask Mark just to talk about some of the patients that we're hearing about from mostly... Yeah. ..through doctors, but also through ourselves. Mark, just talk about some of the difficult-to-treat patients and what we're hearing from doctors. Yeah. I hesitate to do this, but I'm going to tell a joke. One of the sort of old teachings of medicine is, and this is done in a cartoon form with an older doctor talking to a younger doctor walking out of a patient's room, and the advice is, "When what you've advised works, don't act surprised." I think one of the real joys of this launch for me has been talking to my colleagues, as Liz pointed out. They're surprised at how applicable this is to a large population of patients they've previously treated with surgery. What we're hearing anecdotally, as Liz said, is that patients are asking for this drug, and they come into their doctor's office requesting, having heard about the gel. I would expect that trend will continue. The other thing that's been very surprising to me, or interesting to me, is that we're hearing that patients who've had a lot of surgery and a lot of disease and a lot of different therapies are kind of getting cured, so to speak. Their disease is really eradicated when they use ZUSDURI, and a number of my colleagues have actually called me very surprised to say, "Hey, this is a person I tried everything in, and this is the first thing that's really worked." The kind of thing where the patient comes in in tears saying, "Wow, finally, I don't have to have surgery anymore, or as frequent intervention as we've been doing before." It's really nice. It actually aligns nicely with work done by UNC on our ENVISION cohort, where when we asked patients who'd had a TURBT and then had experience with what was then UGN-102 and is now ZUSDURI, which they'd prefer, and then 90% of patients wanted to do the ZUSDURI therapy rather than surgery. It's beginning to kind of line up anecdotal experience, what we've seen from scholarship, and then just personal experience with patients who've previously been treated with surgery. It's very encouraging. Yeah. It definitely sounds like it. Okay, I want to go back to one of the metrics that Liz mentioned briefly and so did Chris. This repeat prescriber rate. If you're at 40% of prescribing physicians actually either repeat in potentially the same patient or other patients, maybe you could go into some more specifics on what exactly you think the plan is to increase that proportion of prescribers that are repeating, and how to basically keep the ones that are already using in multiple patients or not. Do you want to comment? I think Liz mentioned this too, Tara, I think the important part is, we want to continue to drive breadth of utilization, right? We talk about our prescriber target universe is about 8,000 physicians, and at the end of March, we had a little over 250 physicians who have used ZUSDURI. Plenty of room for us to continue to drive breadth of utilization. To your point, what's really encouraging for us is the adopter rate, right? Those are the physicians who may have tried it on one patient and then have moved along the continuum that Liz mentioned and are now willing to treat on multiple patients. We went from 30% of our physicians at the end of the year were repeat writers to now 40%. It's a balance. We want to make sure we're continuing to drive depth of utilization in that adopter base and really get people who are one-time writers to multiple writers. We're going to continue to focus on that. While at the same time, really, with a lot of room to run on the number of actual writers of ZUSDURI as well. Yeah, I think the depth of the patient population gets to their experience. One of the things we're really focused on is ensuring that their first experience is a positive experience. We have a lot of roles in the field. In addition to your sort of traditional rep, we have a nurse educator, we have field reimbursement managers, we have regional operations managers. What they do is, I call it the easy button. Staff to seamlessly integrate ZUSDURI into their practice. I think when you do that and they see, "Oh, okay, not only am I getting positive results from my patients, but it's easy for me to do, and it fits and it flows." Then the practice economics piece of it is another piece, and we're seeing really good reimbursement. They're seeing the practice economics. When all of those things come together, I think that's when you start to see the real depth. Even Dr. Berger commented on the panel that every patient that they've looked through their database, they know these patients. Now they've identified these low-grade intermediate-risk patients. When they come in, they know to consider ZUSDURI. I think that's really important. The other thing is making sure that doctors, to Mark's point, are at least talking to their patient about alternatives, that they hear about ZUSDURI, that's important. We are ourselves, we've talked about this before, we're really going to elevate some of our own initiatives toward patients to ensure that patients are aware. Second half of 2026 into 2027, really having that as a key driver for repeat usage and trial for that matter. Okay. Yes, definitely. Okay, great. I do want to make sure that we spend a little bit more time on the pipeline among 103 and 501. I feel like obligatory need to ask the question on your thoughts on competition and how the IR market could potentially play out. INLEXZO I know was approved with in high risk, of course, a pretty staggering price, but they're also developing in the IR space. We have CG that might be approved in the next couple of years, also in high risk, but we have IR data coming up. Tyra also has IR data coming up, and so maybe just your thoughts on not only upcoming data sets and how you think that they could compare to ZUSDURI, but really how you see all of these therapies playing out in the IR space. Yeah, I'm going to ask Mark to comment first, and then I'll add any commentary. Mark. Yeah. Thanks, Liz. Tara, thanks for the question. I think what we learned at the AUA, and I think this comes through in the panel discussion with the KOLs that we did on that Sunday, is that now that ZUSDURI is out there, and now people are beginning to understand how it works, and coupled with the durability data that were recently released, showing 65% durability of response in a complete responder set of three years. People are beginning to think that when a patient with intermediate-risk disease recurs after standard of care therapy, which in this country is a TURBT, typically not augmented by adjuvant chemotherapy, the new choice for that patient feels like ZUSDURI. A number of the doctors said that. It is very acceptable to patients. The workflow is very compatible with what goes on in a urologist's office. The impact on the patient is minimal, and the outcome is favorable, and there's long durability of that response. What I heard docs say, and I've heard this in more than one venue, is now that ZUSDURI is there, it is conceivable that what will happen is ZUSDURI will be the go-to for recurrent patients. When patients recur, if they do after ZUSDURI, remembering that only 20% of people didn't get a complete response and that durability at three years is 65%, then an adjuvant therapy might be applicable. It's very important also for everybody to remember that in contrast to ZUSDURI, which is a primary therapy, the other therapies that are being approved in high-grade disease, which might migrate into the intermediate-risk space, are also adjuvants. They will follow surgery. They are not primary therapies, a key distinguisher and differentiator for patients and for physicians. Not only is it adjuvant, I think the other thing we've talked about, and Mark talks about this a lot too, is just the burden of administration. We're six weeks, you're done. I often like to think my new sort of mantra is recurrence-free and treatment-free living. Because when you have six weeks you're done in these recurrent patients versus everyone else, is that the burden of administration is much higher. CG as an example, you get your six weeks, you might get reinduced if you don't get a CR, you have maintenance therapy. The same thing with J&J, when you think about INLEXZO or the FGFR TKI that will be in low-grade. I think Mark's right, and that's what we're hearing, and I think we have not only the data on our side, because keep in mind, our data is just with ZUSDURI. Everyone else's data is, "I did surgery plus this." We think that we have set a very high bar from an efficacy and safety standpoint for others to come in. Having said that, I've always been a big proponent of more therapies, because one, these are not cures, unfortunately. Patients will recur, and I also think that it's good to have other companies talking about that, because then that's what happens, right? You start to expand the category. We believe that we have the ability to maintain our base at the same time that others come in and maybe grow the space. Okay, great. Thanks. Yeah, so we can use the last five minutes, I guess, to go over the other pipeline programs. I want to start with UGN-103. I know we have the six months results now. Maybe you could tell us a little bit more about the filing timeline and what could be included there, and maybe your confidence in it being approved on the single trial platform, I guess. Yep. Mark? Yeah. Our plan is still to submit in Q3. We're on track to do that. As you said, we've released the six-month data, very encouraging, very much in line with our experience with ZUSDURI, as was the complete response rate at three months. As we have done before, both with JELMYTO and with ZUSDURI, because we want to move this forward quickly, and it's a regular review, so it will take 10 months. We're going to submit with the data that we have with a plan to update with 12-month durability data, which we know the agency will want for the cohort. At Liz's insistence, as she has said before publicly, we were very clear about the agreement with the FDA about the acceptability of the single-arm trial and the endpoints that we would be providing. We have agreement in writing that this trial is an acceptable way of presenting data on UGN-103 as a successor molecule to the ZUSDURI. We're quite confident in our design and the data that we'll be presenting, and we're very optimistic based on what we've seen so far. Okay. Just to be very clear, that would anticipate approval in 2027, I'll defer to Liz regarding the mechanics of the launch and the substitution of UGN-103 for ZUSDURI. Yeah. Yeah, from that standpoint, look, I think we're going to do it right. We want to make sure we have the J-code first, then the worst thing that could happen is a physician writes a drug that's not there. We want to make sure that we do it right. The transition time, well, TBD, just know that we're going to focus on making sure we do it at a time that it's optimal for the market from that perspective. Yep, makes sense. Okay. All right. Now I want to talk about UGN-501 oncolytic virus. Maybe you can remind us the various advantages that you think that UGN-501 has, why it was attractive to you to bring it in, and just, yeah, how it compares to other oncolytic viruses in development. Mark? Sure. Yeah. Just to set the stage on this, and I know we have little time, so let me be very brief. The oncolytic virus concept is basically in the hands of many who have preceded us, an immunomodulatory program where the virus infects tumor cells, and then lyses them, and the release of tumor antigens is thought to incite a primary immune response. One key differentiator with respect to UGN-501 that we found very attractive is it has actually been rationally designed, including using AI, to take advantage of the fact that as a very potent, highly replicative virus that is widely taken up by both normal and tumor cells by virtue of its fiber and some other issues related to the design of the virus. It gets into everything, but it can only replicate successfully inside of tumor cells because they have a deficient DNA replication machinery that the virus takes advantage of. It only works in tumor cells. It's very specific for tumor cells, and it is highly potent with respect to the ability to kill tumor cells. It actually starts by acting like chemotherapy and secondarily like immunotherapy. It is a one-two punch, which is quite different than the way most oncolytic viruses are thought to act. Highly potent, highly replicative, widely distributed, easily taken up, and we think very appropriate for use initially in the urinary tract and to treat urothelial carcinoma, but also with potential, as Liz has said publicly before, for treatment of other cancers, and we will certainly explore those opportunities once we've moved forward with our urothelial cancer program. Okay, great. This, you're developing first with a liquid formulation, right? You're moving it into RTGel formulation eventually, right? Maybe you could tell us a little bit more of that. Yes, we are completing our IND-enabling studies for the liquid or the aqueous-based delivery system, and we're going to take that into phase I this year. That will begin this year. That said, we're very excited at the possibility that our RTGel platform can provide a better way of delivering the virus that would in fact facilitate even better performance, better dosing, potentially better intervals between doses. We are actively exploring that as well, and we hope to roll that out after we move forward with the initial aqueous program that's going to start this year. Yes, we are very optimistic about the benefits of combining the two assets. Okay. Great, perfect timing on that, Mark. I guess, since we are up on time, I want to thank you for joining us, everyone for listening, please vote for Cowen for Extel. We appreciate it. Always good to see you. Thank you very much. You too. Bye, guys. Bye-bye.