Conference Transcript - URGN 2026-05-19

Ram Selva Raju, Analyst — H.C. Wainwright

Hello, everyone, and welcome to this next in a series of fireside chats here at the Wainwright BioConnect conference. My name is Ram Selvaraju, and I'm a managing director and senior health care equity research analyst here at H.C. Wainwright. I'm joined by the next company on our roster, which is Eurogen Pharma, traded under the ticker symbol URGN on the NASDAQ. We cover Eurogen Pharma with a buy rating and 12-month price target of $45 per share. I'm joined here on the stage by Liz Barrett, Chief Executive Officer, and Mark Schoenberg, Chief Medical Officer. It's a pleasure to have you with us.

Liz Barrett, CEO

Pleasure is ours. Thank you.

Ram Selva Raju, Analyst — H.C. Wainwright

So, you know, for those who don't know, Urogen has two commercial stage products currently on the market. One of these was brought to market years ago, during the pandemic actually, for treatment of upper tract urothelial carcinoma. And the second, which was launched much more recently last year, is called Zesturi for treatment of low-grade, intermediate-risk, non-muscle-invasive bladder cancer. And I think it's there that we really should start. Both these assets are based on your proprietary technology platform. I think, Liz, it would be helpful if you could just tell the audience a little bit about that, the reverse thermostable gel. And utilize a very well-characterized and widely known chemoblative agent called mitomycin C. but I think also it would be really helpful to spotlight the non-muscle invasive bladder cancer opportunity just in terms of the total patient population and the

Liz Barrett, CEO

unmet need. Sure I'm actually gonna ask Mark to talk about the technology and and then I'll come back on the market size. Oh well thanks so the proprietary

Mark Schoenberg, Other

technology RT gel is a mixture of inert polymers proprietary mixture that when when cooled, forms a liquid, so it's sort of counter-intuitive. It's at a cool temperature, it's a liquid and when the gel or the polymers are instilled into a body cavity like the urinary bladder or the interior of the kidney and the solution rises to body temperature, it forms a soft gel that then stays in residence for four to six hours, slowly disintegrating and it is by this mechanism that we're able to mix this proprietary set of polymers with drugs like mitomycin C to deliver them in a depot form and that forms the basis for the therapeutic effects that we see in our patients who are treated with these products.

Liz Barrett, CEO

When you think about the non-muslim invasive bladder cancer space, it's actually pretty complex. And in the U.S. alone, there's about 800,000 people living with non-muslim invasive bladder cancer. And the space where wasustury is is in low-grade, intermediate-risk non-muslim invasive bladder cancer. there's about 60 recurrent in the recurrent setting about 20,000 newly diagnosed that are considered low-grade IR but this the pool of patients that are the recurrent patients get pulled from about 400,000 patients and again this is in the US alone actually low grade is the more common you see you would sometimes think that probably high grade would would be we'll talk a little bit about both high grade and low grade and Mark can describe the differences between that, but it's important, particularly because our medicine that we just got approved as a story is for low-grade, intermediate risk, non-muscle invasive bladder cancer. There's a lot of characteristics that make it that, again, low-grade, and that's a disease of recurrence. It's not a disease of progression, and it's not a disease where there's a risk of mortality. There's a very, very, very low percentage of patients. So what you're managing is the recurrence. And these patients, unfortunately, have a lot of recurrences over their lifetime.

Ram Selva Raju, Analyst — H.C. Wainwright

And pertinent to the recurrences, historically, before the advent of a drug like Zesturi, how were low-grade patients treated? I think in particular, our audience would benefit from a description of the nature of the surgical procedure that was typically applied. And to what extent is Zesturi capable of supplanting or replacing this type of invasive procedure for these patients.

Liz Barrett, CEO

Yeah, Mark, can you explain and describe a TRBT? I'm gonna try.

Mark Schoenberg, Other

Endoscopic surgery for this particular malignancy originates in New York, actually, at the beginning of the 20th century. So doctors, to this day, have put scopes with lenses inside the urinary tract and have applied various forms of energy to these tumors to ablate them and remove them. It's a surgical procedure done under anesthesia. It can be extremely complicated to do. It actually can take some time to do. And because the patient population being operated on is older and has comorbidities, it can be complex to recover those patients from these interventions. Nonetheless, until the advent of Zesturi, this was the standard of care for the management of recurrent disease in the population Liz has described. So patients would undergo, with some regularity, regular maintenance surgical procedures to remove recurrent disease.

Ram Selva Raju, Analyst — H.C. Wainwright

And in the context of Zesturi's, let's call it pharmacoeconomic as well as therapeutic impact on the lives of patients within MIBC. Liz, as you said earlier, this is a disease that people live with for a very long time. if historically recurrences had to be managed with TURBT you know approximately you know how many TURBT procedures might a drug like Zesturi which and you know you can please feel free to elaborate on the long-term clinical data that's recently been presented at AUA on Zesturi's long-term benefit particularly in terms of complete response right which is putting people into remission. How many TURBT procedures, theoretically, could Zystery save a patient from going through?

Liz Barrett, CEO

Yeah, it's a great question. I also want to go back to, if you talk to a doctor, they think of a TURBT as being a fairly benign procedure, but you talk to patients, it is not a benign procedure. And trust me, the first time that I went with Mark into surgery to see a TURBT, I was like, oh my goodness. and but so recently to your point we're very excited about last week we shared our 36 month data from our envision study and what it showed was that 64% of patients that it got an initial CR was still in CR at 36 months why is this so critical it's critical for a lot of reasons one first to say that our median still hasn't been reached so excited about the fact that what we know then is that the median is more than 36 months. Our internal projections is that it will probably likely be similar to gel mito, which is at 48 months. So these patients, 23% of patients will have five or more recurrences. 68% will have two or more recurrences. So to your point, it really depends obviously on the patient, but they would hopefully forego many TURBTs through in their lifetime and the other thing about the story now we need to generate data on retreatment but we do expect assuming a patient gets a good response that they would be able to be retreated and that's something that we'll be looking to generate data the good news bad news is until patients recur you can't really generate that data so but we will be looking to do that but we're happy about the fact that the durability which is the most important thing you You know it's great, our CR is about 80%, and then about 80% of patients still in CR at 12 months, but to see this longer term data, very compelling.

Ram Selva Raju, Analyst — H.C. Wainwright

You know, I think it would also be helpful to understand the competitive advantage conferred by the convenience of Sesturi. So maybe you could talk through, you know, the frequency of administration that is required with Sesturi and how that compares to both other already approved therapeutics as well as some late stage agents that have been talked about extensively aimed at non-muscle invasive bladder cancer?

Liz Barrett, CEO

Sure, no, absolutely. One of the things that we love to start talking about now is not only recurrence-free, but treatment-free living. And what do I mean by that? Our drug is you don't have to have surgery. That's the first and most important thing, especially for these patients. But you come in once a week for six weeks, and then you're done. And a lot of people asked us, well, why didn't you do maintenance? And one of the reasons was the burden of administration for patients. We wanted to see how the drug would do with just six weeks. And given the response that we've seen so far, we're really thrilled that we did that. When you start to look at the other agents, and Mark can comment on this as well, the first thing is that they're in adjuvant setting. So they are in addition to. So when you're looking at the data, you have to take that into consideration. So the data that they're sharing is a surgery plus the treatment. But in almost all the cases, not only do they have the six weeks of, quote-unquote, induction, but they allow a re-induction, and then there's maintenance beyond that. And that's in both the high-grade and those that are being studied now in low-grade IR that they are requiring both a surgery and maintenance beyond. So we really think that we have a competitive advantage, and we're the most patient-friendly therapy in this space. And, you know, I think that's an exciting thing for patients. I don't know if you have anything to add.

Mark Schoenberg, Other

The only thing I'd add, and I think you've said it well, is that in our field right now, there's a huge emphasis on trying to examine possibilities for de-intensifying care, particularly for this population of patients. And as Liz points out, the story is six weeks and you're done. Everything else is surgery and then a year or two of additional therapy with multiple visits, potential installations of various devices for drug administration, much more burdensome, and that actually figures importantly into how we're thinking into the future about how to cure for this population.

Ram Selva Raju, Analyst — H.C. Wainwright

I think it would also be helpful to recap the commercial performance of the enterprise. And Gelmito has now been on the market for several years. I think it would be helpful to talk through the kind of revenue base you've been able to build there. but then more importantly how Zesturi has done since launch and particularly since the J code came into effect at the beginning of this year and the degree to which you know that is streamlining

Liz Barrett, CEO

and facilitating access oh absolutely so as you mentioned earlier we launched Jalmito into the pandemic so about seven years ago about six years ago I'm sorry and for low-grade upper tracheal failure carcinoma. Now it's really important to understand that gel mito because it's the upper tract the installation is very different. You have to have fluoroscopy you either have to go up and manipulate the upper tract or you have to have a nephrostomy tube inserted and the patient population are only about 6,000 patients in the U.S. so about 3,000 newly diagnosed and about 3,000 recurrent patients. So we are around a hundred million dollar drug a year. We've been growing at low single digits, and we expect to continue to grow at that low single digit. There's still patients that need to get gel mito, very similar to what you see in bladder. Every year, a certain number of patients will recur and have the opportunity potentially to see gel mito. What gel mito also allows is for these patients not to lose their kidney, and we are talking about an elderly patient population. So when we think about, again, gel mito, it's about $100 million. If you compare that to Zosturi, one, the market is about 10 times the size. So, you know, we often talk about Zosturi being a billion-plus, you know, peak revenue medicine. That's easy when you say, well, we're already with Gelmito at about 100 million, 10 times the size, so you sort of get there pretty easily. But there are a lot of important factors that go into that. One, it's actually a much simpler product to give. So while they're similar, it's much easier because in the physician office, particularly in the community practice, it's very easy to insert the catheter into the bladder, deliver the medicine. It's very similar to what they're used to doing with other intravascular therapies, so it reaches the market. What we shared in 2025 is that in Q4, there was about $14 million in revenue. Now, this was pre-J code. We received our J code on January 1st, and we've reported $29.2 million of revenue in Q1. And what we've also said is that we're comfortable with where consensus is, both for the quarters and for the year, and we expect linear growth. So we do expect to continue to see quarter-over-quarter growth. I think the other thing we shared when you try to compare it with Jalmito is in February, already in February, the second month on the market, we saw that the early indicators that we look at, patient enrollment forms, new patient starts, and obviously number of doses, surpassed gel mito in February. And we expect that to continue to grow. So look, it's not rocket science to say if you're at $100 million of gel mito revenue and you're already surpassed them in February. Now, of course, the pricing is a little different, so the story's a little bit less costly than gel mito, but it's easy to get to see in where we are from a run rate perspective.

Ram Selva Raju, Analyst — H.C. Wainwright

I think it's also important for our audience to reflect on two key things. Both Gelmido and Zesturi are proprietary products that Eurogen sells. But the fact that you had all of this commercial experience accumulated with Gelmido, the fact that you had to launch it into an adverse market environment means that this is a very battle-tested commercial organization and the two products are highly synergistic because the prescriber base is clearly heavily overlapping and because of the presence of GelMido and the revenue base that you have already built, the sales force effectively pays for itself, the sales force that you are using to sell this story.

Liz Barrett, CEO

Absolutely. Now, we did increase the number of our customer-facing people employees when we launched Zesturi because, you know, you had about 5,000 targets to move to about 8,000 targets. So to your point, again, Gelmito, there's only 6,000 patients, but they're being seen by everybody in urology. The difference for Zesturi is everybody's seeing these patients, but they're seeing multiples of these patients. So while, you know, every doctor who uses Gelmito uses Zesturi. Not every Zesturi doctor is a Gelmito doctor, but we are seeing even some, what I call reverse halo. You go in to talk about Zesturi and then you also talk about Gelmito. So where a physician may not have been willing to use Gelmito in the past for one or two of their patients, if they start to adopt this type of therapy for Zesturi, they may be more likely to adopt it for upper tract as well.

Ram Selva Raju, Analyst — H.C. Wainwright

And with respect to how you expect overall the customer mix to evolve for Zesturi, talk a little bit about how Zesturi is priced, how you expect that to compare to existing marketed as well as late-stage therapeutics in the NMIBC context, particularly for low-grade patients, and how this may affect the degree to which Zesturi winds up being ported through the community hospital channel versus the academic center channel and what implications that has ultimately for volume.

Liz Barrett, CEO

Yeah, it's important to note that most of these patients get seen in the community. So about 70% of these patients will initially be in the community. Mark works at an institution and they typically see the worst of the patients, right, either after a patient has recurred so many times, but the majority of the particularly low-grade patient is seen in the community. In the beginning of the launch though, most of our usage was in the institutions, and it was there driven by reimbursement. So to your point, what are the dynamics that occur? Our community practice are much more concerned about the financials. They wanna make sure that they get reimbursed because it is their private practice, and so if they lose on one patient, they're very concerned about that, right? the revenue that they lose. So we do a lot to support the community doctor, and they want to make sure they get to keep those patients. So while everybody talks about TRBT being the bread and butter of urologists, frankly, being able to do intravascular therapy in the office is much more, from a practice economic perspective, it's actually more beneficial to the doctor. So while right now we were at kind of 60-40 in 2025, we're already at 50-50, We expect that to flip, and you'll probably get about 65% of the revenue coming from community. And so not only is it because that's where the patients are seen initially, but doctors figure out pretty quickly that it fits into their workflow and that it can be beneficial for them in their practice.

Ram Selva Raju, Analyst — H.C. Wainwright

And I think it's important to note that many times in the community setting, the deployment of an extremely expensive drug is extremely difficult. You know, some of you may have heard about 340B and the impact of that. But because Asturias priced the way it is, that is not an issue, and it will not be an issue in the future.

Liz Barrett, CEO

Yeah, when you compare it to your point against some of the other medicines that are on the market, first of all, they're starting in high grade, and so their pricing is priced for high grade. We start in low grade, and our pricing is for low grade. You know, you're not going to use a million-dollar drug in a low-grade patient that you know doesn't have the risk of mortality or, you know, moving. So it's going to be interesting to see how things play out when these expensive high-grade drugs move into the low-grade space. Unfortunately, the intensity of the amount of drug they're getting is actually still the same, even though it's in low-grade, but the way that they are, the way that their clinical studies are and the way they're dosing is they're still getting the same amount. So it's going to be interesting, and I do believe urologists are much more price sensitive than say oncologists are. So how are they going to position themselves in the low grade space from a pricing standpoint will be very interesting. And I think it's gonna be not only a physician decision but a payer decision down the road as well.

Ram Selva Raju, Analyst — H.C. Wainwright

I think it would also be important to A, highlight the complex nature of the formulation, both in the case of gel mito as well as in the case of Zesturi. Those in the audience who know some of the work that my group has historically done in the specialty biopharmaceutical space know that I tend to gravitate towards situations where the product, for want of a better term, is not readily genericizable and presents myriad challenges to a potential copycat entrant. But I think that's an appropriate place to start when thinking not only about how difficult Gelmaido and Zesturi might be for generic companies to copy and even enter the marketplace, but also the lifecycle management strategy that you already have. And certainly, I think the centerpiece of this is the recent data that was generated from the Utopia trial with the follow-on, the successor molecule to the successor product to the story, especially now that you have six-month CR data.

Liz Barrett, CEO

Yeah, absolutely. So I'll ask Mark just to talk, one, about sort of our products and why they're unique and why our technology is unique, and then our life cycle from moving, and then I'll sort of chime in on the sort of commercial part of that.

Mark Schoenberg, Other

So because of IP considerations, although actually because we were looking for a secondary supplier of mitomycin, we came upon an opportunity to create successor molecules to gel mito and zesteri using a proprietary version of mitomycin made by a company called Medac in Germany. In partnering with them, what we realized was, and I'll defer to Liz to talk about the IP implications of this, an opportunity to pair this specific mitomycin with our gel technology to create two successor molecules which are currently named UGN-103 for Zosturi, Zosturi successor molecule and UGN-104 for gel mito, which are in the final phases of phase three evaluation. 103 will be submitted as a new NDA in the third quarter of this year with the expectation through a 10-month review process of approval in 27, and then Liz will tell you a little bit about the launch strategy and withdrawal of Zesturi that will follow that. And then 104 follows all of that by about a year. It is expected that we will complete enrollment of the 104 trial this year, and then approval will be in 29. So we have two additional drugs that will follow the path of gel mito and Zesturi. And in addition to those opportunities that you'll hear about in a second from an IP perspective, the complexity of the gel, making the gel has been alluded to already. We've had large pharmaceutical companies approach us for help in trying to figure out what we're doing. Liz would want to comment further on that, but the gel itself is exceedingly difficult to make in large part because there are some very subtle changes associated with achieving the parameters required in order to deliver this to the urinary tract. But in any event, we have two successor molecules that will be available in the market long before our IP lapses on the existing drugs that are currently being marketed. I don't know if you want to comment further.

Liz Barrett, CEO

No, absolutely. So as we roll out, you know, it's interesting because to Mark's point, when we originally went to the FDA, we said, well, what can we do in our new molecule? And they said they're different, so you're going to have to run a clinical study. And then since then, what they've done is develop what we call product-specific guidance. and that says that anyone coming in is going to have to demonstrate that they are identical. There's no such thing, they say there's no biosimilar, there's no similarities, there's no equivalents, you must demonstrate you're identical, and if you can't do that, then you're going to have to run a clinical study. Where we are with, I think everybody knows that Teva filed an ANDA, they still have not received conditional approval from that, and so that's telling for us. They also narrowed their claims in the lawsuit because it used to be non-infringement or invalidity. Now they're saying, well, we infringe. So there's just an invalidity claim, which we know is a higher bar. So we feel very strongly about our IP. We feel very strongly about the know-how, you know, based on what Mark was saying. And in addition to that, the expectation is that as we roll out UGM 103 and UGM 104, we will pull Zesturi and Gelmaido off of the market. So even if someone post-2031 figures out a way to design it, then they're going to enter into a market where there's not generic substitution. There's not interchangeability. So they would have to launch it as more of a branded product. And so we feel, again, really good about where our patents are. UGM 103 and 104 go through 2042. That allows us to launch the new studies that Mark was talking about. So we have a long time to be able to study and hopefully launch in areas around urethelial cancers. And to your question the other day, absolutely expect to be able to show Zesturi and Jalmito's use across the urethelial cancer landscape.

Ram Selva Raju, Analyst — H.C. Wainwright

So I think, you know, just some parting thoughts. Firstly, our valuation does not give you credit for 103 or 104. And, you know, we are effectively modeling gradual erosion of both Jalmito and Zesturi's sales starting in 2031. Clearly, if you are successful with the LCM strategy involving 103 and 104, the market exclusivity period could be extended by more than a decade. Secondly, you know, you alluded to this a little bit, you are looking at the possible applicability of your technology of mitomycin as a chemoablative agent, you know, not just in low grade but also in high grade. And you also have a whole pipeline beyond all of this, you know, including an oncolytic virus candidate, which we haven't had time to talk about today, which aren't included in our valuation assessment either. So I think those are important things for our audience to kind of reflect on. That may be, I think, where we're going to have to leave it.

Liz Barrett, CEO

Although I think you have to raise your price target is what you're saying. Thank you.

Ram Selva Raju, Analyst — H.C. Wainwright

Thank you so much for being with us. I really appreciate your telling us and telling the audience about Eurogen Pharma. Please keep an eye on this company. To our audience, thank you so much for your attention.

Liz Barrett, CEO

Thanks, Ram.

Ram Selva Raju, Analyst — H.C. Wainwright

We appreciate it.