Great. Thanks, everyone, for being here. My name is Yanan Zhu. I'm one of the biotech analysts here at Wells Fargo. It is my great pleasure to be joined by the management team of UroGen. With me here are Liz Barrett, CEO, and Chris Degnan, CFO. Liz and Chris, thank you so much for being here.
Thank you. Thank you for having us.
Great to be here.
Wonderful. I wonder if you could kick us off with an introduction of the company's initiatives and perhaps touch on, after recent development, how would you describe the company today, and which has been the most important development that shaped the company so far?
Oh, that's a lot of questions into one. I'm going to just take a step back. Most people, I think, know about UroGen and how UroGen came to be, but for those that don't, our company was founded on the basis of a proprietary technology called RTGel. The reason that it was discovered was because there were a group of urologists who identified a high unmet need in the area of urothelial cancers, and the inability of medicines to dwell in the cavity long enough to have an effect.
The current standard of care across urothelial cancers is surgery. You can imagine, because these aren't cures, they continue to have surgery time and time again. Non-muscle invasive bladder cancer is a large tumor with lots of patients that live with non-muscle invasive bladder cancer.
The good news is a large portion of them are considered low grade, so they're not really concerned about mortality, but it's more a matter of recurrence. What the technology allows to do is for medicine to dwell long enough to actually kill the cancer that's in there. One of the things that we've been able to demonstrate over the years is the durability of that response.
Because one of the biggest challenges for these patients is they recur. A physician, a surgeon can only cut out the tumor that they can see, and unfortunately, there's usually a tumor in the lining, and so therefore that's why a drug such as ours has been successful, and the efficacy has been great. I've been with the company now 7.5 years, so it's been a long journey.
Although Mark, our Chief Medical Officer, has been around 13 years. We were really committed to seeing this come to fruition. What we've really learned over the years is that these drugs work. I think it's very encouraging to see these patients that are average age of 74 when they're diagnosed, but then they've had to live with years of these multiple surgeries, actually having a therapy that will allow them to get into a complete response and stay in a complete response because that's really important.
It's hard to say what's the most critical thing that has happened to the company, but what has shifted the company and has changed our company is the approval of ZUSDURI in bladder cancer. When our original, our first product was for upper tract urothelial cancer, but it's a small patient population.
The idea for the company was always to move into non-muscle invasive bladder cancer. Because of the FDA requirements, that took several years, as it typically does, but we were successful. The data has been unprecedented, frankly, in this space, and we were able to get an approval and then launch about a year ago. So, exciting time for our company. We're pleased to be here and think about today.
Now what we think about is what's next? Where are we? You talked about who are we as a company. We are clearly leaders in urothelial cancers, but we also want to build a long-term sustainable growth company and see ourselves continuing to advance treatment in urothelial cancers, but also to diversify outside and into other specialty cancers.
Right. Yeah. Hopefully, we can touch on
Oh, sure.
also on the expansion aspect. Could you give a sense of the size of the low-grade upper tract, and also low-grade, the ZUSDURI indication, low-grade intermediate in NMIBC?
Yeah. Do you want to talk about the market and the size of the market?
Sure. For low-grade upper tract, where JELMYTO is indicated is roughly 6,000 to 7,000 patients a year in the U.S. As Liz mentioned, ZUSDURI's a much larger market opportunity, so the low-grade intermediate risk, non-muscle invasive market, the recurrent population, which is where ZUSDURI is indicated, is roughly 60,000 patients, about 10x the size.
Got it. That's super helpful. Maybe we can talk about the ZUSDURI launch. It has accelerated very notably in the quarterly numbers. I was wondering which commercial indicator gives you the greatest confidence in the trajectory, and what has been the most effective in generating demand in terms of what you think.
Sure. Chris, why don't you comment, and then I'll add.
Sure. Importantly, we got the permanent J-code for ZUSDURI effective January 1. Yanan, as you said, we definitely saw an inflection from the J-code, and we're really pleased with the trajectory, in terms of where revenues are trending, b ut it's still early. In terms of what indicators we're really focused on, I think first and foremost is just prescriber base.
As you think about just taking a step back, our target universe, the broad universe, is about 8,000 physicians, of which our core targets are around 6,500. In terms of number of prescribers through Q2, we have 450. There's a long way for us to go to continue to drive breadth of utilization in terms of going from 450 and penetrating that core target universe. The other piece is driving depth of utilization.
What we are also pleased to see is the percentage of physicians that are repeat writers growing. For the first quarter of the year, about 40% of our writers had treated more than one patient, and through the second quarter, that had improved to 45%. We expect to see continued improvement in terms of percentage of repeat writers, but we also want to make sure we continue to drive the breadth of prescribers.
You asked about what we have seen that has been most successful from driving the growth, and it is really this sort of shift from hospital-based to community-based, and most patients are seen in the community setting. While a lot of our early adopters have been in institutions, what we are starting to see, most of the patients get seen in the community.
We are starting to see the business shift more to community, and that is where more patients are. The more we can do that, we want to continue, obviously, to drive patients that are in the institutions, in the hospitals, and those are some of our greatest champions, to be honest with you, so far that were early adopters.
But if we can penetrate, as Chris Degnan said, the breadth and depth of the large community practices where most of the patients are, that is what we will see. We are still very early in, but we are seeing that adoption increase.
Great. So the intermediate risk, NMIBC landscape is getting more active.
Yes.
So when physicians compare emerging options, which attributes are likely to matter the most, and where do you think the story stands apart?
I feel very comfortable and confident where we are. I think we have the best value proposition, not only for doctors but for patients, importantly. As they're right now, most of the other drugs are only approved or their first indication will be in high grade. So we're in low grade, intermediate risk, so it will still be a couple of years before we see anybody in this space.
One, we have the first-mover advantage, and we'll be on the market 2-3 years before we see any competition in this space. Importantly, our drug and our data reflect just the treatment with our drug. So when we talk about an 80% complete response rate and an 80% durability, and having gotten 36 month data and still haven't reached the median, that is just with ZUSDURI.
When you look at all of the other medicines that are being studied in this space, it's their drug after surgery.
You have to take into account, well, what would have happened? What's the incremental benefit of the drug to the surgery, whereas ours is just our drug. In addition to that, we talk about not only recurrence free, but treatment-free living for patients. So we are once a week for 6 weeks, and then you're done.
All of the other treatments that are coming in are not only adjuvant, so they have to be done in addition to surgery, but they have a maintenance schedule. Sometimes they have a reinduction, or sometimes they have a maintenance, b ut you're on drug for a minimum of a year, sometimes longer.
If you can get the type of results that we've seen and be able to give patients their life back in the sense of not only can they live recurrence free, but they can also live treatment free, we think that value proposition is much better than what you're seeing with any impending potential competitors coming in.
Great. Thanks for sharing those product attributes. As doctors use the drug, what are you learning about patient selection, repeat use, and integration into practice? Are community versus academic doctors behave differently on those metrics?
You want to start ?
Yeah. I'll start maybe with the last piece first. In terms of the shift in business, Liz mentioned this a little bit. Community practices really want reimbursement confidence. During the period of the miscellaneous J-code, they were more hesitant to use the product. Last year, we saw about 60% of our business sitting in the hospital academic setting, b ut as Liz also mentioned, 70% of the patients are in the community practices.
So once we got the J-code, they had greater reimbursement confidence, and we're starting to see the business shift there. But they also, urologists want to test it. They want to, as our market access head says, they want to crawl, walk, and then run.
They are going to want to try it on one or two patients generally, understand how to incorporate it into the workflow, make sure they get reimbursed before they start to adopt it more broadly. We are working our way through that continuum.
Got it. Great. I think you have more than 14,000 sites and 450 unique prescribers, as you mentioned earlier. That is a very broad foundation for the launch. How do you convert more of these ready-to-treat sites to turn them into active and repeat prescribers, and what barriers still needs to be addressed?
Yeah.
The word foundation, you used the appropriate one. We had roughly 1,500 or so sites that were activated, and that was a big focus last year, was getting sites activated. What that means is getting them prepared operationally to be able to acquire the product and institute it into their practice. So they are set up, and now the focus has been on driving that adoption.
Again, I think a big focus and a leading indicator to really hone in on is that prescriber base. Now that we have sites able to order the product, understand how to use the product, it is getting them to work through that adoption curve. It comes back to making sure they have the conviction and the clinical profile, which the feedback we are getting is the clinical data resonates, specifically the durability of response that we are seeing.
We are changing the treatment paradigm. These are urologists who have been doing surgery for these patients for decades, and we are the first therapeutic option here. So it is getting them to think about things differently and to start to adopt a therapeutic approach, how to incorporate that in.
The third leg of the stool is then getting them confidence in the reimbursement pathway. Importantly, we have really good reimbursement and coverage. 96% of payers are covering ZUSDURI. We have not had any reimbursement denials, but they want to see it to believe it. So getting them to use it, see the reimbursement come through, and get that confidence, all that is going to lead to further adoption.
I think you're changing behavior, as Chris said. If you look at the adoption so far, we're very comfortable with where we are. You'd always like for it to be faster, but we do know that urologists are going to take their time and do that. I look at it and I see physicians who have adopted it as standard of care already.
We have some doctors who every patient who is a recurrent patient is getting ZUSDURI, or they at least have the option to get ZUSDURI. The majority. Then you've got some physicians who are saying, "Well, I'm only going to use it in those that I can't take to surgery." Then you have everything in between. That's really our job, right? Is to move those patients on the left over to the right.
I think that's when you'll really see acceleration, when you start to see more doctors that believe this is the best way to treat patients. I'm going to at least have all my patients have the option to have ZUSDURI. So we're moving through that adoption curve, and as Chris said, we're still very early innings with that, b ut the good news is through our ATU research, 100% of physicians who have used it said they'll use it again.
Once they do get experience, that's a big driver for us, is getting more doctors to get that first patient on drug.
Right. Got it. What should investors monitor to assess the pace and durability of ZUSDURI's growth through the rest of the year? Has the early launch experience changed your view of the long-term commercial potential?
I'll answer the second and then ask Chris to go to the first. Yes, I believe that the success that we've had so far, we've talked about a $1.2 billion peak with 20% market share. Do I think there's an opportunity to go beyond that? Absolutely. I think that as more doctors, again, take this into consideration for this is where they want to be standard of care.
I think the other piece of that is around patients. The other thing that we've learned is patients prefer this to having another surgery. One of the strategies that we're going to implement, particularly in 2027, is around engaging patients. So we're going to go direct to patients.
I think from that standpoint, if you look at what is the opportunity, what is the opportunity to accelerate, and we haven't talked about that yet, but we've talked publicly about life cycle management, going into high grade. When you start to think about the patient population high grade, now all of a sudden your $1.2 billion opportunity becomes a $2 billion opportunity plus. We have a lot of opportunity with ZUSDURI and UGN-103 beyond where we are today.
If you just to think about the trajectory we talked about, urologists tend to be a little bit slower to adopt. We see this curve more as a steady linear growth curve, and we can have some quarter-to-quarter variability. One of the things we mentioned is Q3 specifically, we've seen it with JELMYTO, you see it with your patient visits just in general, and urology practices tend to slow down a little bit in July and August.
There are some of those dynamics that we're seeing. But again, it's early in terms of the launch, and so we still expect meaningful quarter-over-quarter growth and generally thinking about things in terms of a linear growth trend.
Great. Thanks for sharing that. Let's also touch on JELMYTO. It delivered 7% growth in 2025 after years of double-digit growth. What role can it continue to play in your portfolio, and what are the key levers to expand the business?
Yep.
I think JELMYTO is still going to play a key role. We've talked about the guidance range was $97 million to $101 million for the brand. So, we still expect slow, steady growth as the product matures. And so it's a nice product for us. It's a smaller market compared to ZUSDURI, but it's a nice foundational product for the company. And then some of the dynamics we're watching, we've obviously been very focused on ZUSDURI in terms of the launch this year.
The other thing is, even though it's a smaller rare disease indication, there has been an increased amount of competitive activity in the space in terms of clinical trials. And so with those recruitments going on in a rare disease indication, it's also something we're monitoring in terms of impact in JELMYTO, but still an important part of the portfolio.
Great. Thanks. You mentioned life cycle management.
Yes.
Let's talk about that. Can you walk through the latest progress for UGN-103, UGN-104, and explain the strategic value of these programs beyond their manufacturing and supply benefits?
Yes, absolutely. UGN-103 and UGN-104 are what we call our next generation formulation for ZUSDURI and JELMYTO. I am sure you know, we actually submitted the UGN-103 to the FDA for an approval in low-grade intermediate-risk non-muscle invasive bladder cancer, and we expect to hear something back from them. It takes 60 days before you get quote-unquote accepted, but the PDUFA date should be June of next year.
The intention, a couple things. One, most of the benefit you actually really talked about, manufacturing, the stability of the drug, the solubility of the drug allows for more efficient mixing. In addition to that, we also will have extended shelf life. Today, ZUSDURI, it is 7 days from the time it is mixed, it must be put into a patient. We will have a few weeks with the new drug.
There are a lot of benefits that are not, quote-unquote, "clinical benefits," but definitely operational efficiencies. With that, one of the things when we initially went to the FDA to say, "Okay, here is a new formulation. What does that look like?" They were very clear, this is a different drug, and therefore, you have to do clinical trials, which is what we did. So we did a clinical trial on UGN-103.
We are in the process of doing that with UGN-104. We will be fully enrolled this year for JELMYTO, and then as soon as we are able to get 6 months of durability data for UGN-104, then we will file that with the FDA as well. Because these are proprietary mitomycin with our proprietary gel, we also were able to get patent extent. So we had patents for both of those, for UGN-103 and UGN-104, through December of 2041.
What that allows us to do is it allows us that once UGN-103, as an example, we get the J-code, because we're not going to launch it with a miscellaneous code. But once we get the J-code, then we would switch the business from ZUSDURI to UGN-103 with the benefit of the operational and efficiencies associated with that, and then pulls ZUSDURI and JELMYTO off the market.
What that allows us to do, one, is ensure supply. That's very important, UGN-103. So the supplier that we now have, our partner medac, who's in Germany, has unlimited supply, so we don't have to worry any supply constraints. So that's really important for patients. It also makes it easier, as we talked about, for reconstitution, and we have longer patent. That allows us then to do more around life cycle management.
With UGN-103, we're going to study that, which we'll start this year of study, in high-grade non-muscle invasive bladder cancer. So right now we're in low grade, we'll have high grade. We're going to focus initially on papillary disease, but we do want to study UGN-103 across the entire patient population of non-muscle invasive bladder cancer. So very excited about the potential not only of UGN-103 in this space, but even potentially in the future, combinations with other drugs and stuff as we really expect to be a leader across all of bladder cancer.
Okay, great. You mentioned PDUFA is next year, mid-year. If UGN-103 is approved, how do you envision managing the transition? Could the next generation product coexist? Could the two generations coexist?
Right.
Would you think of some migration?
Yeah. So it's probably not in our best interest to have both coexist. The main reason is the confusion that it cause, the complexity in the business to manage that, but importantly, the confusion in the marketplace. So what we will do is we'll have a switch strategy. The good news is, because we have the 2044 patent that we just got a notice of allowance on ZUSDURI, we don't have to be in a rush to do it.
We have the time, so once we get the J-code, once operationally we're in a good place, then we will switch, and we'll move to the new generation. That makes the most sense for our business. It makes the most sense for our customers, and it's in the best interest of everybody all around.
We will do that, and it allows us also, again, to do more clinical research in different patient populations.
Okay, great. I wanted to talk about this very interesting strategy you're pursuing. You're evaluating UGN-103 in newly diagnosed intermediate-risk disease, whereas ZUSDURI currently addresses recurrent-
Recurrent, yes.
population, right? What is the rationale for entering the treatment pathway earlier?
Yeah.
How could that expand the opportunity?
I think it's really important to note that what we want to do is we want to give physicians the data that they need to support them to use ZUSDURI how they want to use it. When I think about it from a patient perspective, the best way to use ZUSDURI is as a primary treatment. So no adjuvant, so no surgery, just use it as a primary. You can't do that in newly diagnosed.
In newly diagnosed patients, they need to have surgery because it's a diagnostic. So they do a TURBT, they capture the diagnostics. They know whether it's high grade or low grade. We want to be able to generate data in that space post-TURBT, so that if a doctor wants to use it post-TURBT, then they have the data to be able to do that.
It's really to inform what we do in the future. We already know that it works in newly diagnosed patients because our ATLAS data, if you go back and look at our ATLAS data, even as a primary treatment without TURBT, we know it works in newly diagnosed patients. What we agreed to with the FDA is when we did, we switched to the single arm study that we would just do recurrent patients because that was the higher unmet need.
We know that, again, patients newly diagnosed need to do a TURBT for diagnostic purposes. So when I mentioned earlier around our strategy to cover all really patient populations in low grade and high grade, that's part of that strategy. Is making sure that if a doctor wants to use it in an adjuvant setting, we're generating some safety data in that way.
We don't promote adjuvant because it's not in our label. That could inform, we may decide to try to go for a label in newly diagnosed, but when we really think about the best way to use these medicines, it is in our current recurrent patient primary treatment, be able to give them six weeks and them to go on with their life.
So while we want to do that, we want to do it to support the community. We want to do it so that physicians can use our drug across the continuum. But if I'm a patient, I know how I'm going to want to take it.
Got it. Thank you. You are also pursuing high risk.
Yes
NMIBC papillary disease. This is also an area that's getting increasingly competitive.
In terms of development landscape. What unmet need could 103 address, and what would the program need to demonstrate a differentiated position?
I think with UGN-103 in high-grade disease, there's a few things. Most everyone else, all of the ones that are currently either approved or in phase III pivotal studies, are studying high grade with CIS, plus or minus papillary disease. We will be doing just papillary disease, not with CIS.
Now, in the future, we also want to do CIS as well, but we believe that if you think about it from a medicinal perspective, where do we know mitomycin works? We believe it works in papillary disease. I do think that the data that J&J has put up with INLEXXO shows that a longer exposure of a chemotherapeutic agent works, because it worked there. We think that the approach is very similar in that sense. We also think that mitomycin, we'll have to see, might be a better option.
We know that it's stronger than gemcitabine in some cases. We believe that the data there will be compelling, and we think it will be easier to give than some of the current other treatment there. I think the last thing to note is, remember that unfortunately, none of these are cures. We're not curing patients. I'd love to be able to cure patients, but we're not there yet.
T hese patients will cycle through multiple therapies, and when you start to look at the data of some of the data that's been shared by some of the potential competitors coming in, it's not that compelling. I think that we have the opportunity to have the type of data that you're seeing now, which we consider the bar to be the ENLEXXO and the CG data in high grade.
We think we can get there with our drug, and we think patients need more options. They need more options because if they fail other treatments, they're either going to have to have a radical cystectomy, they may move to muscle-invasive bladder cancer. So being able to give these patients more option is in everybody's best interest. We think we have an opportunity to expand our portfolio and our franchise of UGN-103 into high-grade disease.
Got it. Thank you. For that high-grade disease, can you characterize that opportunity size compared with-
Yeah, it's interesting. What's interesting about high grade versus low grade is there's about a third of the number of patients, but the value per patient is significantly higher. So example, we have 60 in the low grade, intermediate risk, recurrent patient population. There's about 60,000 patients.
There's about 20,000 high grade non-muscle invasive bladder cancer patients, b ut the value per patient, because you do, in that world, you do maintenance. So if you think about it just from a perspective of JELMYTO, it's about $130,000, about $100,000 net for low grade for six doses, where you would get six in induction and then nine. So you're talking two to two and a half times the number of doses. So now all of a sudden the value per patient.
If you look at the TAM of the low-grade market and the TAM of the high-grade market, they're actually very similar. Even though there's many more patients in the low-grade space, because of the value per patient and the pricing in low grade, the high-grade TAM is just as big.
Great. Let's talk about UGN-501.
Okay.
Can you give us your conviction for the program, and what are the key steps that we can expect as it moves into clinical development?
Sure. Absolutely. UGN-501 is an oncolytic virus, and we believe a next generation oncolytic virus, and has the potential to be a best in class oncolytic virus. What's very unique about UGN-501 is the properties allow for not only direct tumor lysis, so not only does it kill tumor cells directly, but it elicits the immune response.
When you think about an oncolytic virus, you're really thinking about the immune system and that you're soliciting the immune response, but the UGN-501 is very unique in the sense that it does both. The other unique thing about UGN-501 versus other oncolytic virus is the ability to enter the cell. It has a broader gateway to cells than some of the others do, as an example. It should be able to enter the cells easier.
The preclinical work that we've done shows that it's the most potent oncolytic virus when we compare it to others that are out there today. That's preclinical. Now the good news is we filed our IND and we're moving to phase I, so first in man in bladder cancer, in high-grade bladder cancer.
We just talked about the fact that even though there's other drugs there's still a need for more drugs in this space. The great news about 501 is it also allows our company to move outside of urothelial cancers. UGN-501 can be a catalyst because UGN-501, as an oncolytic virus, should work across multiple other tumors. One of the things that we'll be focused on working on right now is actually prioritizing what tumors, where do we go next with UGN-501.
While we're doing the phase I study in bladder cancer, we're also doing the analysis to say in 2027, what tumors outside of bladder cancer will we take UGN-501. That's a great area of growth for us and a good catalyst for our company to build beyond urothelial cancers.
Right. That is indeed very exciting development. Definitely looking forward to follow that.
Great. Thank you.
How does the IntraGel collaboration fit into your long-term growth strategy?
You talk about it?
Yeah, it is a nice fit and complementary. The one thing with the RTGel is it is not biodegradable. It was designed specifically to be in the urinary tract, and the RTGel ultimately needs an exit. We have been looking for a potential to find a biodegradable gel, which would allow us to instill oncolytic therapies into closed system solid tumors.
We were looking through this and our BD team identified it, and the IntraGel technology, they have some early data already in the clinic with using cisplatin in their gel in patients with advanced head and neck cancer, and is showing some promising results and a really good safety profile. With this deal, it gives us some optionality.
We're investing $7 million into IntraGel, and with that, we get rights to exclusive license their head neck cancer asset on the back of their phase II data. They're going to be heading into phase II next year. We'll get a chance to see that data before we make a decision on whether we want to license it in. It also gives us an opportunity to use their gel in up to three additional oncology indications. These are things that we're also looking at in terms of expanding our pipeline.
Great. We only have a minute left, so I wanted to ask the team to comment on what do you see as the biggest disconnect between your underlying assets and progress versus how the company is viewed by investors, and what could help close that gap?
Yeah, Chris loves to answer that question. It's his favorite question to answer.
Thanks. Good question. We 've come a long way this year, but to your point, I think there's more room for us to go in terms of value appreciation. I think coming into the year, part of it was the story was a show-me story. We're the first approved therapeutic option in this space. How big is this market? Is it truly over a billion-dollar product opportunity?
I think our first two quarters are giving people further confidence that we're on that trajectory, and we need to continue to do that. I think continuing to progress our next-gen formulations, continuing to build out our intellectual property portfolio, all those things are giving people further confidence in the durability of our revenues.
The third is just where things are going to shake out from a competitive positioning perspective, and I think Liz did a really good job of just highlighting the value proposition of the story. Then as we see these competitive data sets, further confidence that the story has a very unique value proposition. I think those are the three main areas.
Wonderful. With that, I think we are right on time. Thanks, Liz.
Thank you.
Thanks-
Thanks for having us.
Chris, for your very helpful insights.
Well, thank you.
Pleasure.
We appreciate it. Thank you.
Thanks, all.