GUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - UROGEN PHARMA LTD

All right, so welcome to this next Fireside Chat with Eurogen Pharma. It's my great pleasure to welcome Liz Barnett, President and CEO, as well as Chris Dagnon, Chief Financial Officer. Welcome. Thanks for joining us today. Thanks. Thanks. Thanks for having us. Thanks, Michael. So, Liz, Eurogen is in a very important phase of a company's lifecycle, sort of completing the early stages of the Sesturi launch. you're expanding your pipeline. Why don't we start with just a big picture question, and so how do you think you're doing this position heading into 2027? Yeah, great question, obviously. Happy to be here and sharing our story, and it has been, you know, a long story past, right, getting to where we are today, but what an exciting time for us as a company to your point we launched our bladder cancer drug about a year ago but got our permanent j code the beginning of this year so we really see this as our first first year launch and it's just been an exciting time for us it's been a great year in the in the launch of Sisturi we have a smaller drug called gelmito that's on the market so we have two commercial products but to yourpoint we also have a pipeline and we're excited about where we're going both as leaders in urothelial cancers, but also developing a long-term sustainable growth company. And we've settled on our strategic plan with our board, excited about the fact that we not only see great growth in the near term, but we also see a path to continued leadership and growth for the long term. So that's what we're here to do. We're here to build a long-term sustainable growth company, both for patients, impacting patients, and for our shareholders to be able to see that we can continue to grow, you know, for the long haul. So again, exciting time for our company as we shift from really a clinical stage to a commercial and clinical stage company. So that's sort of how we're looking as we get into 2027 and beyond. Yeah. Maybe a few questions on this story. So the permanent J code has had a real impact on uptake and growth trajectory earlier this year. As you stand today, and you just reported third quarter earnings recently, maybe comment a bit about how has this story been adopted? What types of patients are using the drug in the life cycle of an MIBC patient? And what are the main drivers of additional growth? Yeah, sure. I'll ask Chris to start, and I'll comment at commentary. Yeah, so you mentioned the JCO. The JCO is certainly important here, and I think what's also important with the story is we're the first FDA-approved product in this space, right? So we are changing the treatment paradigm where urologists for these patients and what they're dealing with in the intermediate risk space is multiple recurrences. And so the patients will, you know, come in, they'll have a surgery, and then, unfortunately, a lot of these patients will constantly recur. And so, you know, for us, it's one, getting urologists to understand the value proposition that we have in terms of the clinical profile of the drug, but then also for them to understand, you know how to change their practice in terms of getting them to use it from an operational workflow perspective. And then also confidence for them in terms of the reimbursement profile. And the good news for us is we have really strong reimbursement with over 95% of covered lives having access to the drug. But urologist tend to be slower to adopt. They don't have a whole lot of familiarity with buy and bill, and so for us, it's getting them, you know, to first try the product. And what they're typically doing is they're trying it on one or two patients. They will see how it works from an operational perspective. They'll make sure they have the reimbursement, and then they start to expand their adoption. So we think about where we are for the launch. You know, we have 6,500 core targets that we're focused on. We're still in the early stages of getting them first to try the, the product, And so through September this year, we have over 650 physicians that have now tried Sisturi. So we're making good progress, but we're still early in terms of getting physicians to try the drug. And then the other thing that we're really focused on is how many of these physicians become adopters or repeat writers. So once they get confidence in the profile of the drug, once they give confidence that they're getting reimbursed as they would expect, starting to then treat multiple patients. And so we're also really pleased to see how many writers are becoming repeat writers. And so, we're making good, steady progress on both fronts. What are you seeing so far on repeat usage? It seems like a lot of growth is driven by adding new prescribers to your funnel. But what are you saying in terms of reusing and the same docs? Actually, I know you guys don't see this level of data, but the depth is what's been driving our revenue so far. And that is you do have this group of champions and real adopters who have adopted it for the majority of their patients. And it's your typical curve, right? You have those that are early adopters. They really buy into it. They say, this is the way I'm going to treat my patients. And they adopt it for majority of Their patients. And then you have others on the other end that Chris was talking about that either haven't tried it yet or, oh, I'm going to try it on one patient and make sure that all of the things go right before I do and so the good news is is that the the early adopters are driving debt and so our revenue so far has come from a lot of these big you know adopters and so as as we go forward we'll continue to do that but we need to continue to get the breadth of users because as Chris said we only have 660 out of the 6,000. So still a long way to go there. And look, as we drive into 2027, not only are we engaging the patients, ensuring that physicians try the medicine, because 100% of the docs in our ATU that tried it said they will use it again. And so we have to make sure that they are helping them to identify these patients and really going from trial list to true adopters. Right. And so in the third quarter, you reported 68 million sales on 35% growth. Can you comment on how much of that was driven by new prescriptions versus repeat use? Yeah, you want to talk about that? Yeah, so I think it's both. And that's where we are in this stage of the launch, right? We talk about the fact, again, that we think, you know, just given the urologists are a little bit slower to adopt, that expect this to kind of be a steady growth trend over the launch of the drug. And so we think about this as, you know, a four- to five-year time to peak as opposed to maybe a more accelerated growth curve that you would see in the oncology space two to three years to peak. And so part of that is just, you Know, steadily adding, and I think you're seeing that in the KPIs, steadily added new writers. So we went from, you Now, just over 450 unique prescribers through Q2 to over 650 in Q3. So we've done a nice job of continuing to add, but again, many more prescribers to add as we think about growth. But then also, you know, as you think about how many of those writers were repeat writers, 45% of our prescriber base through Q2 were repeat riders. That's grown to 50%. So we think importantly as we grow this brand over time, we need to continue to add breadth of writers and then continue to drive further depth of penetration within those writers. Great. Right. And in terms of what you're hearing back in sort of clinical practice right now, how many patients or docs complete all six installations? The majority, almost all of them do. OK. And any read on what real world durability looks like relative to the study experience? Still early, right, for durability. But I will tell you that we have seen and heard, and this is anecdotal information, But the ATU that we did, like I said, where 100% of the doctors said that they would use it again, I will say you've had doctors pleasantly surprised that even in these heavily pretreated patients, they're seeing good responses, either complete responses or near-complete responses. And that is actually what helps, right? They see that as actually working, and that's making a big difference. So their real-world usage is mirroring what we showed in the clinical study. Okay, great. And then in the past, you talked about this 1 billion peak sales opportunity with a 20% market penetration. Are you still confident in that estimate? And yeah, I think you mentioned the 4 to 5 years to peak. I guess what has to happen to get there? Yeah. So the four to five years is really since the J code. Right. So going back to January, we absolutely still believe in the billion plus, you know, peak. As I said, you Know, when you think about it from a penetration perspective and, you KNOW, we Absolutely believe that there's an opportunity. Is there an opportunity to do better? Yes. You Know, we've talked about a billion plus and what we're trying to do is to help everybody understand that even though we are changing the way doctors practice medicine, We do think this is a better way to treat patients. And so as urologists start to adopt, we think we can, that billion dollars. And I think, frankly, our trend to date is already showing that, right? Yeah. And then obviously there is, you guys were the first product, the first systemic product on the market for intermediate risk NMIVC. There's obviously other people working on products, change a CT oncology, for example, have data readout soon. And so how do you envision the landscape evolving longer term and the use case for the story? Yeah. Unfortunately, I've been around for a really long time. So I've spent the last 30 years in oncology. And what sort of surprises me in the bladder cancer space is you hear it's highly competitive. It's highly repetitive. Actually, it isn't. You look at lung cancer, look at prostate cancer, look at how many in kidney cancer drugs that there are. What you see when you have multiple entrants is a few things. One grows the market. I don't think you could show me an analog that shows that it doesn't grow the market when you Have multiple players. The second thing is we're trying to get surgeons either to not do surgery in our case and use our drug instead are to use drugs in addition to surgery. having multiple companies out there talking to physicians about changing the way they practice is actually going to help us all and i think one of my biggest frustrations is this idea of a zero sum game it's not a zero sum game we've talked about like you said our billion dollars it's not a huge market share that you have to get to getto that billion plus there's plenty of room for multiple players in this space and somebody coming in i think actually helped and i've said I've been saying that, you know, for the last couple of years, actually grows the market and you see more and more physicians change the way they practice. So I'm excited about the fact, frankly, that there's more drugs coming in. I'm also happy for patients because, unfortunately, none of these are cures. And patients, while we are getting great durability with our drug, others, you Know, coming in, you're going to cycle through multiple therapies. And that's what happens in other cancers as well, right? you cycle through therapies. And that's a good thing for patients. We believe that Zasturi and UGM-103 has a very compelling value proposition, even in comparison to the competition. We are the only ones that are non-surgical. So we are the only ones who have an approval. And frankly, no one else is coming for a while. So, we're still the only one out there for quite a way in the future. But when they do, we're the only ones that offer a non-surgical option. So when you look at our data, 80% complete response rate, 80 percent of those patients still in response at a year and 36 months, we still haven't reached the median. When you think about that type of data and you're treating a patient for six weeks and they're done, no surgery, six weeks. So the idea of being able to offer a patient not only recurrence-free living, but treatment-free living everybody else coming into this space a low-grade space you're treating them for a longer period of time and by the way you're doing surgery first so when you think about even the the efficacy that you're seeing when as they you know share their data remember that it is an additional surgery whereas ours is just us alone one thing I've heard from investors is if one of those products is being used in the adjuvant setting including new patients you know up front does that reduce the flow through doesn't shrink the pie from the market essentially yeah look i call that cross-line reduction you know it's like when you use it in in first line so newly diagnosis it it it doesn't impact it for a really long time i think what everybody needs to remember is there's 400,000 people living in the U.S. with low-grade bladder cancer. In any given year, about 15% of them will recur, and that's where we get our patient population. Anybody who gets used in the newly diagnosed space, you'd have to have 100% penetration and newly diagnosed for many years for that number to go down, because you're taking these 60,000 out of a $400,000, I mean, 400,000 person prevalent pool. So as they move from this newly diagnosed into the prevalent pool, right, you still have that. So it doesn't impact it. And Mark Schomburg is our chief medical officer. He's here. And what he'll tell you, and we've seen it as well, is not everybody who's newly diagnosed, the current standard of care is just surgery, right? And you're, particularly for low grade, you're going to, most of doctors will say, look, I'm going to do the surgery. I'll see how it goes. If they recur, then I'll use, you know, I only have about 20% who do more than just surgery in the initial, and that may grow, right, as others come in in the newly diagnosed space, but it's not going to impact the number of patients available to us in the recurrent setting. You'd have to do 10 to 20 years for that to start to happen. Right. Okay, super helpful. All right, and then I had a question on UGN-103, which is your next-gen product candidate. And just remind us how that will be used to manage the life cycle of the story and how you will transition patients. Yeah, you want to talk about that? Yeah, so UGM-104 offers a couple of operational and then also manufacturing enhancements. it's it's a more soluble products is a different excipient and so you know our product needs to be mixed with our gel so it allows the hospitals that buy the drug to be able to mix it more efficiently the other thing is once it's been mixed it's more stable and so right now once it has been mixed and for community practices we mix it for them and then ship it just in time they have to instill within seven days and so by with the new product it'll be several weeks, shelf life once reconstituted, so it'll give the community practices some more operational flexibility. Also the other important part is just as we think about supply efficiency and capacity, it can be manufactured much more quickly. So we can lyophilize this drug product in three days versus, you know, currently our formulation takes about three weeks. So that will have some slight COGS benefit, but more importantly just supply flexibility and efficiency. So those are, you know, some big components there. The other piece is, you You know, 103 does have additional intellectual property associated with it. So both Zastorian 103 have a newly issued method of use patent that goes all the way out to July of 2044. 103 also has composition of matter for the proprietary mitomycin that goes to mid-2035. And it also has a separate patent with their RT gel that goes out to mid 2045. All the way through 2041. So, you know, good, strong protection around 103. And for all the operational enhancements we talked about as well as the IP, we're now taking 103 beyond intermediate risk. And we're likely to talk about it, but now moving that into a high-risk papillary study later this year. Yes, that's a good segue to my next question. So, yeah, talk about that high-risk papillary opportunity and also the competitive landscape and how it might fit in. Yeah, I have the same sort of perspective as when we talk about the, you know, multiple players in the low-grade space. High-grade is obviously more critical for patients. So these patients, unfortunately, a lot of them used to lose their bladder because you had to take the bladder out to ensure that they didn't progress to muscle invasion. With new therapies coming in, that allows these patients to have therapy and continue to keep their bladder intact. And that's very important. You can imagine for the elderly patient, but even for younger patients, have to go through life without their bladder. So it's a very important and critical time. We believe that there's an opportunity. There's about 20,000 patients in the papillary-only area. And again, as I mentioned before, because none of these are cures, they'll cycle through multiple medicines. You know, I think that the data we've shown in IR and data that has been shown in the high-grade space with using traditional chemotherapies shows that they do work in this patient. And so that gives us high confidence, along with J&J's and Lexo, also a very similar approach. You know we chose mitomycin, they chose gemcitabine. But the idea of being able to have this longer dwell time for a high-grade patient, and, you know, we believe that there's a lot of room in that space for multiple therapies. And we also have not only UGM-103 in that place, and we'll study it not just in papillary, but we look to study it across all the type of patients in high-grad because we believe it will work in that phase as well. So we're excited about expanding beyond. If we talk about the billion dollars in IR, then you have to add the opportunity, which is a similar opportunity, frankly, in the high-grade space. That adds to our long-term growth strategy and positioning of UGM-103 slash Sisturi, where we are now. Again, I think it's a great thing for patients. Physicians are excited about seeing multiple therapies, and we see an opportunity not only for UGM-103 in that space, but also for UGN-501, which is our own next-generation oncolytic virus that we just announced we dosed our first patient in our phase one study. So excited about that as well. Yeah, that's another good segue just on 501. Maybe talk about the mechanism here, how valid is that, and what are the opportunities that you could presume. Yeah. You know, when we purchased the UGN501 from Econovir, it's important to note that Econivir had been studying it systemically in other tumors, not in bladder cancer, but they had done some preclinical work in bladder cancer. So we understood that it worked. What's interesting about UGn501 is it has sort of a dual mechanism. And so it has direct tumor lysis. So it kills tumors directly and elicits an immune response. So you kind of get this one-two punch, and that's differentiated versus other oncolytic viruses that are out there. So we believe that will be better, more potent. We have to prove that and demonstrate that out in clinical trials, which is what we've done. In addition to that, we're studying it in our gel. And the reason we're doing that is the same reason we use it with our current drugs is the ability to have them dwell longer. So kill more of the tumor cells and elicit more of a response we believe can be a very positive thing. And because it's being delivered locally, you don't see the same systemic side effects that you see if you delivered it from a systemic standpoint. And then lastly, I'll just say with UGN501, it also gives our company a bridge outside of bladder cancer because we know it works in other cancers. So some monoculative viruses don't work across multiple cancers, but we know that this one does because of the work that Econovir did. And so we're looking at doing an intratumorally in other cancer. So bridge our company outside of just being in urothelial cancers also to other specialty cancers. Very interesting. And then maybe just a commercial question. So Jill Mito had a little bit of a weak quarter in the third. So what happened then? What's going on in the market for Jill Mido? And how could that return back to growth? Yeah, I'll let Chris talk about kind of where we are now. And then we'll talk a little but about our plan to bring that back to growth. Yeah, so just in the quarter, a couple of dynamics. So one, you know, we did have a one-off unexpected growth to that adjustment that we had in the quarter. So, you knows, CMS has a discarded drug provision in Jill Muto there. There's some wastes associated with the administration of that drug. We got an invoice that went all the way back to 2024, unexpected, that basically created a $1.5 million one-time charge that put some pressure in the quarter. The other thing we're seeing in the space, we talked about how big the bladder cancer opportunity is, gel mito is a smaller rare disease indication, right? I mean, you're talking about 6,000 patients in the US. And interestingly, there's a lot of recent competitive interest in this space in terms of new trials that have begun enrolling specifically in the U.S. and UTUC. And so beyond just our 104 program, which is the next-gen formulation of Gelmito, and we're enrolling patients and expect to complete enrollment in either this quarter or early next, there are other companies that are also enrolling a lot trials. And so when you're talking about a rare disease indication and these patients enrolling in a trial versus using gel mito, that has certainly put some additional pressure on our revenue profile. Yeah, and if you think about it, just from our UGN 104 study, where we're rolling about 50% of our patients in the U.S., it's a hit of about $3.5 to $4 million for the year against gel mitos. That was a decision. We knew that that was a risk, but frankly, for the longer term, it was the right decision. And so if you just took just our own clinical study and then the one and a half million, you're getting closer to where we had, you know, guided in the beginning of the year for Jalmito. And so we believe that there's still that opportunity. What are we doing to ensure that we return back to growth is we're putting together what we call a strike team for Jomito. Because, look, it is very similar to most drugs out there, promotionally sensitive. And we made the decision to prioritize Zesturi, and we still think that was the right decision. And, you know, you can see just by what we've been able to deliver in Zestari this year, we entered the year, the analyst consensus, it was 140 million, as I said, and we've hit 147 million in the three quarters with Zestiri. So I think we've over-delivered in that area, but we, you know, we lost some focus on Jamaito. And so what we really have learned is you really do need some specific focus for Jomito. And so we're putting together a 15-person, what we're calling, again, strike team that's only going to be focused on Jomato. And hopefully in 2027, see that. We'll continue to have some pressure from clinical studies, but hopefully continue to see that growth. Because 104 will be fully enrolled, you know, no later than the beginning of 2027. So we won't have that direct pressure. Okay, great. And then last question, with your, you know, OPEX guidance as it stands, how confident are you you could potentially reach profitability without raising additional capital? Yeah, so we are right on the cusp. If you looked, our net loss was $1.5 million in Q3. And with, one, the expected continued growth of Zistori, you knows, as well as in Q2, we also had some one-time costs. For example, the $5 million PDUFA fee that we had for the 103 NDA filing, we expect to be profitable in the fourth quarter of this year. And importantly, we also expect to cash flow positive in the fourth quarter this year, so we have the resources we need to and through profitability. Great, well, that's a good time to wrap up. Let's really appreciate the time today. Of course, thank you. Thanks Michael. Thanks, I appreciate it. Thank you. Thank you, appreciate it