Good morning, and thank you for joining J.P. Morgan's Annual Healthcare Conference. My name is Ling Zhang. I'm a healthcare banker here at J.P. Morgan. Before we begin, just wanna quickly remind our audience to please feel free to submit your questions using the blue button on your screen. We'll address them during Q&A. With that, I'm pleased to introduce this session's presenter, Ms. Liz Barrett, President and CEO of UroGen Pharma. Without further ado, I'll let Liz take it away. Thank you. Thank you, J.P. Morgan, for having us here. This conference is always very special to me because three years ago, I think it was day six of me being in this role that I presented at J.P. Morgan, and so while I do wish, as I think many of you do, we could be in person, just happy to be here with you. I know that you'll be following along with the presentation. I have it in front of me, so I'll try to remember to tell you which slide I'm on. I'm again happy to be here. Apologize upfront about my voice. Just getting over actually COVID, so trying to just having the after effects. Our forward-looking statements as you typically see. Taking a step back and thinking about UroGen and how we actually came to be was really around urologists and urologists dealing with urologic cancers. You know, the current standard of care is really invasive and radical surgery. That's really because there hasn't been medicines that have been able to actually dwell long enough in the cavity to be effective. Because of the anatomical barriers and associated with the normal voiding out of, you know, in the urothelial, there hasn't been, again, an ability to actually treat with medicine. Because of that, even for low-grade diseases, which we are gonna talk about this morning, you really have to go through invasive and radical surgery. We actually, our company came to be because of this. It was actually a challenge that was given to a chemist in Israel. Our company started in Israel and developed, on page four, the RTGel proprietary reverse thermal hydrogel technology. That's why it's called RTGel, i t's reverse thermal. The reason it's called reverse thermal is because it's actually liquid when it's cold and it turns into a gel, and as it hits the warm temperature of the body, increasing the dwell time and allowing exposure over time of medicines to treat cancers in the urothelial. Because of that, we believe has the potential to improve the therapeutic effects. It actually also then disintegrates and uses the natural voiding to exit the body. Our company is really built around, next slide, the organ-sparing non-surgical treatment approach, and we are really fundamentally changing the way that these patients are treated. Our mission is we build novel solutions in urothelial and specialty cancers because patients deserve better. As we're thinking about, again, the standard of care and the invasiveness and repetitive surgeries and loss of organs that these patients face, our ability to develop this technology, this unique technology and bring it to patients, we really believe is changing the way patients are treated. On page seven, as I said, I look back and think about it. Can't believe that it's actually been three years that I've been in this role as Chief Executive Officer and a lot has happened. We've had a lot of challenges and, as many of you have with COVID, but we're really proud of the company and the advance that we've made. We had our FDA approval right in 2020 when COVID started. We really are thrilled with our UGN-102, our phase III study execution. We had a head-to-head study that we've now stopped, and I'm gonna talk more about our streamlined study going forward. That's a pivotal study to get our second approval, hopefully, with UGN-102. We've advanced our immuno-oncology pipeline. We have a pipeline of two products, a CTLA-4 for local delivery as well as a TLR7. I'll talk about that in a moment as well. We've done some nice research collaborations with different institutions and really pleased with our ability to utilize and leverage the uniqueness of our technology to be able to deliver and hopefully deliver more and more treatments to patients in many different areas. We licensed our medicine to Neopharm in Israel. I'm really happy about that because as I said the company was actually founded in Israel based off of the physician's need that was identified there. We're really pleased to be able to offer patients, hopefully soon, the access to our medicine. We launched a named patient program in five European countries, to be able to again allow for access for patients. On the next slide, page eight really talks about our pipeline and why we believe our pipeline is a strong pipeline that will ensure the long-term sustainable growth of UroGen. We've talked earlier about $1 billion+ by the end of 2026, and we do know that this market is a $3 billion+ market. When I talk about this market, what I'm really talking about is urothelial cancers. We also are focused on other specialty cancers, but right now our portfolio is focused on urothelial cancers. Our first medicine, JELMYTO, about 7-9 thousand addressable patient populations. The only medicine ever approved for this, for low-grade UTUC upper tract urothelial cancer. That's a small orphan drug. We're really pleased because a lot of these patients end up losing their kidney. Our second medicine, as I talked about earlier, UGN-102. Right now, there's no FDA-approved medicines, and these patients also go through these repetitive TURBTs. That's in phase III. I'll talk more about that. Again, for low-grade, intermediate-risk non-muscle invasive bladder cancer. Then lastly, our immuno-oncology pipeline, and that area has about 15,000-25,000 patients, and this is in high-grade disease. Our TLR7, as well as UGN-301, which is a CTLA-4. I'll talk in a moment about those. The important thing is that just these three products alone, one, still very high unmet need, very little happening in this space, and three, the ability with just this pipeline that we have today, we're continuing to look for others to add to our pipeline. Just this alone can give us a long-term sustainable growth business. As we move into JELMYTO and changing the treatment paradigm and how things are going, as I said, we were approved in April 2020. We launched in June of that year. We obviously shifted from an in-person launch to a virtual launch. I'm pleased to say that we continue to make progress in this, you know, despite the challenges. Our total revenues, and this is as of the end of September, about $44 million and about $32 million through the first nine months of 2021. We've also guided for the year that we expect to be between $47-$51 million, and that's still our expectation. The great news, though, for patients is that with JELMYTO, there's a 58% complete response. I've been in oncology for a long time, and to get a response efficacy like a 58% is really meaningful. As we move into talking about the opportunity for JELMYTO, again, you know, we talk about the population. About half of the population is newly diagnosed, and about half of the population is this recurrent patient population. Because what happens is these patients either at presentation get endoscopically resected or currently, if they can't get to the tumor, they actually go straight to RNU, which is basically to remove the kidney. In a patient with low-grade disease, that's really an area of opportunity for these patients because they have low-grade disease, which basically means you're managing the recurrence. They're not going to die from their disease. They're having to lose a kidney for a patient in this population, particularly it's an elderly patient population. This really is a big deal. Our ability to bring an alternative to these patients, which we really believe is a better treatment for them. Before we launched JELMYTO, we developed three pillars that we consider to be what are the keys to success. Patient identification, reimbursement, and seamless integration into practices. I'm pleased to say on the next slide number 13, that we are making progress on all three of those. Actually, I guess, the good news is 18 months later, that's still the key success factors for us. Because as I said, the patients are. It's an orphan disease. There are a lot of practices. So sometimes physicians only see one or two of these patients a year. We have larger groups that actually see more of them, and we're pleased that over 700 practices or hospitals have been activated. What does activated mean? It means they've either identified a patient, they treated a patient, or they're ready with all of the logistics to treat a patient once they identify. And 80% of physicians have expressed interest in utilizing JELMYTO, prescribing it over the next 12 months. The second pillar around reimbursement. This is really key, and I think most of you understand it's a buy-and-bill drug. Physician offices and practices, you know, have trepidation about making sure that they're going to get reimbursed. The great news is we have very, very, very strong reimbursement. What we're really working with is a perception and making sure that physicians understand that they are going to get reimbursed. We have, obviously, a hotline that helps them with that. We work with the patient and with their insurer to ensure that they get reimbursed. To date, I'm pleased to say that we have over 99% reimbursement and even the less than 1% that, when I say, hasn't. It just hasn't happened yet. We're just still in the process of making that happen. We feel very good about it. Again, it's more giving the confidence to the practice and the office that they will get reimbursed. That's a big driver for us. Lastly, because this is not a pill, it's not an infusion, it's actually an instillation that has to happen. The drug has to get mixed with the gel. It's the complexity of the logistics are a little bit more than you would expect. Which is why it's really important for our sales reps and our nurse educators and our medical team to be able to go into the office and work with the office. We're really pleased to say that 86 accounts have treated more than one patient. What that tells us is, one, they're happy with the treatment and that the logistics are workable. As I said, not a pill, not an infusion. What happens is It's instilled into the patient and through a catheter or through a nephrostomy tube. Nephrostomy tube is a very interesting area for us because even though we had it in the clinical study, it actually didn't get used in the clinical study. What we are finding is that in practice, actually, and I think, COVID, because of COVID, actually, you know, makes this even more compelling for physician offices, is they're actually able to deliver it through nephrostomy tube, which makes it an easier installation and can be done in the office. We really are gaining a lot of experience, and Dr. Murray is looking to publish on her experience in this area. I think as more physicians get experience, I think you'll see things potentially move toward it because it's an easier installation in the office. I do want to talk a minute about our results because we have had some quarter-over-quarter volatility. I think the good news is that the trend is on the right track. The trend is upward. Even though, again, there's been some quarter-over-quarter volatility really driven by some of the COVID-19 limitations, you know, with inconsistent access. I talked about the logistics, why it's important for our reps to be able to get there. As I mentioned, we've guided for our Q4, and our Q4 will be our biggest revenue quarter since launch. We're excited about that, and we will be sharing our results in the next few weeks. You've seen some volatility. We've got COVID-19. Why are we confident in JELMYTO and confident that JELMYTO will become the standard of care? We have what we call patient enrollment forms, and this is on page 16. It's an early indicator for us of the demand. We've seen steady quarter-over-quarter growth in patient enrollment forms. Then once you have a form, that means you actually have a patient. It takes time. Sometimes, you know, the patient may not be the appropriate patient, but the conversion has been very strong. Of course, sometimes there may be a delay in actually getting the patient treated. We do know by these patient enrollment forms that we continue to see momentum in our adoption. The other reason was we believe, and on the next slide, is around the satisfaction and the research that we've done. If we go out and talk to physicians and they really are satisfied with the product. And then lastly, we have testimonials from both patients and physicians. You know, you can read these yourselves, so I won't read them to you. You know, these, you know, patients understand. They say, "I'm gonna lose my kidney. That's a really big deal, " What happens if something happens to my other kidney?" In some cases, some people only have one kidney. So it's a really big deal for these patients. They are seeking other options. You can see again by some of these quotes, what you know what they've said and how they see it. The same thing with physicians. They've realized this is a paradigm shift for them. It's what we need to do. We need these alternatives, and it's a better management for patients. Next I'm gonna move to UGN-102. We're very excited about the shift with our pivotal study in UGN-102. But before I do, I'll take a step back, and I mentioned this earlier and talked about low-grade versus high-grade disease. This is really important because we often get asked about BCG and other of the products that are in this space or being studied in this space. Most of the products that are being studied in this space are actually being studied in the high-grade area, which I'm gonna talk about in a moment. BCG is actually not used in low-grade disease. Again, very similar to low-grade UTUC, low-grade non-muscle invasive bladder cancer is about repetitive surgery. This patient population on the next slide talks about the success that we've had, but this patient population tends to recur. They go in for these transurethral resection of the bladder tumor. Again, a really big deal for a patient population that's an elderly patient population. They typically have comorbidity. Being able to have an opportunity for them to have a new treatment option that provides them a better outcome is something we're really looking forward to. Another thing to understand is the molecular profiling between low-grade UTUC and low-grade non-muscle invasive bladder cancer are very similar at a genetic mutational driver level. Because of that, we saw very similar results between our JELMYTO and UGN-102, and we're pleased with our phase II study that we've announced 65% complete response and over 70% duration of response. On the next slide, this is a much bigger patient population. We talked about the, you know, 7,000-9,000 patients, around 7,000 patients for low-grade UTUC. Here there's about 80,000 patients. This market's over a $3 billion market, depending on the pricing, which we haven't finalized yet. You've got your newly diagnosed and then again, your recurrent patient population, which goes through these repetitive surgeries. You know, these are patients that typically have they either recur, they have a high burden of disease and multifocal. What we've learned in the research that we've done is that 68% of patients who have a recurrence will typically have two or more recurrences. Actually, 23% of patients have five or more recurrences. The repetitive TURBT is associated independently with an increase in mortality. Just the surgery is an independent risk factor for mortality. Our research physicians will say, off the top of their head, 25% of patients should just not be going through a TURBT. Having nothing to do with their disease. They're just saying they're not in a situation where they should be going through, you know, this type of surgery. They have to go under general anesthesia. It's not a benign surgery. Almost half of the patients told us, without really knowing anything about UGN-102 and the research that we did, that they would choose an intravesical delivery over a TURBT. We've got some research that we're going to be sharing this year that talks about the preference for UGN-102 over TURBT by patients. We're really pleased that we've been working with the FDA. It took us a long time to actually get them to understand the high unmet need in this area and have an alternative approach to demonstrating versus a head-to-head study. The medicines have not typically had to go and demonstrate superiority versus a surgery. We worked very closely with them to really educate the FDA. I will say they've been great to work with, and we're really pleased that now we have a new single-arm phase III study to assess the safety, efficacy, and clinical value of UGN-102, which is called ENVISION. We're in the process of initiating that study. The good news is we're gonna take our ATLAS study sites and really shift them, so our ability to start this study really quickly, and we hope to be sharing over the next few weeks, the kickoff and the actual formal start. We're in the process of doing all the things that we need to do. The good news is that the design on the next slide is very, very similar to the OPTIMA II study. You know, patients, there's a 220-patient study. They'll get their six installations, and then there'll be a follow-up period. Our expectation is that we'll have both a planned and an approval in 2024, assuming we get priority review, which we are hoping and expecting to do. The good news about UGN-102, when you think about the bladder versus the upper tract, there's actually a significant operational advantages for UGN-102. It's much easier to deliver. As a matter of fact, the physician doesn't even have to be there to deliver this. Then we've talked about our in-home study. We've actually already dosed a few patients in our in-home study, and this is really just to show that the ease of being able to administer this medicine and how it can be administered by someone other than a physician. If we do continue to be in challenging situations and these patients, you know, need to be treated at home, that actually they'll be able to. There's not this special equipment, the cystoscopy that you need, like you do with a upper tract. We're looking very much forward to UGN-102 bringing this paradigm-shifting change, and because we do believe it's. If you talk to physicians on the next slide, they'll tell you most cited in what they need is a more effective intravesical therapy for these patients. The good news is that 96% of physicians and urologists say that they would use UGN-102 within the first two years of approval. Again, we believe that this is a better treatment for patients. We're excited about this as investigational, you know, medicine and we hope that if approved, this will again advance the standard of care for these patients. Next, I'm gonna talk about UGN-301 as we move into our uro-oncology pipeline and looking at both monotherapy and combination. This is in high-grade disease, so this is the patient population that you hear most about when you hear about non-muscle invasive bladder cancer. You know, there is a high mortality rate for patients with high-grade disease, and so we believe we have a differentiated approach in this area. This patient population is about 25,000 patients newly diagnosed and about 15,000 that are considered to be BCG refractory. Obviously, we'll focus on that patient population first, but then plan to move into the newly diagnosed. Why are we in this area? We're in this area because our TLR7, when we did some preclinical work, it demonstrated that if you combine our TLR7 with a checkpoint inhibitor and specifically CTLA-4, that you actually saw a benefit in survival. We're excited about the preclinical work that we've done and the clinical work we've done on our TLR and moving into the clinic shortly with our UGN-301. We're excited about that. We expect to take our CTLA-4 and actually combine it with other immune modulators as well as potential other chemotherapies, because we think that that's a differentiated approach, what others are doing in this area. As we look ahead to 2022, a lot of priorities, a lot of things that we're excited about. We do believe that 2022 is gonna be the most pivotal year for our company. We will continue to accelerate JELMYTO and what we call the new normal. Regardless of COVID or not, we know that we've got to make sure that these patients are able to get treated. We will be fully enrolled in the new single-arm phase III study of UGN-102 this year, and then we'll continue to follow those patients. As I just mentioned, we'll be moving into first human studies with UGN-301 and launch into a combination study with 301 and other combinations in the high-grade disease. We wanna continue to look for business development opportunities that fit within our company and leverage the opportunity and ensure a strong financial balance sheet. As everybody knows, it's been a challenging year for our sector and for UroGen, but we're really confident that 2022 will demonstrate the benefit of our medicines and the value that our medicines bring. As we look at areas, again, uro-oncology, we're all in. Also looking at other areas of specialty cancers that are adjacent to urology, like Gynecologic cancers, head and neck cancers, you know, GI cancers. Those are the areas that we are looking at. Obviously also we have other partners that have been interested in our technology and how they may be able to use the RTGel technology in areas outside of uro-oncology and specialty oncology. We'll continue to prosecute that and to work with others that are interested in our technology to leverage the technology to be able to advance care in many areas. We have an experienced management team. I think we have all of the bases covered. We've got people, our head of development, a lot of experience, and she's done a great job of leading a team to be able to see that we're developed. I think most of you know Dr. Mark Schoenberg, who's still a treating urologist, so the things that we talk about every day, he experiences. Jeff, with the experience that he has in the commercial, particularly in the urology space. You know, I'm really pleased, you know, to have the rest of the team here that we have the management team. I feel very fortunate to have attracted and retained such a great management team. Lastly, the finances. You know, we talked about the end of September, you know, no debt. We had about $110 million in cash. We again have guided our revenue for the year being $47 million-$51 million. We look forward to sharing those with you soon. With that, I'm gonna stop and turn it over for Q&A. Thank you, Liz, for an excellent presentation. We'll now turn to some of the questions. Just to remind our audience again, please feel free to submit your questions using the blue button on your screen. First of all, for JELMYTO, maybe, you know, you touched on this, but maybe dive a little deeper on the impact of COVID on revenue and why management still maintains confidence. Yeah, sure. No, it's a great question. Look, what has COVID meant to us? It's been different regionally. It's changed, you know, and it's changed over time, as everybody knows. But what's important for JELMYTO, because I talked about the complexity of needing. It's an installation, so you really need someone in the office to help the logistics and ensure that that happens. This isn't a one-on-one talk to the physician. They write a prescription, and then you go home. The rep really needs to be there and be engaged in helping and ensuring that that happens. Because of COVID, there's been sometimes limited access. Again, it's sometimes great, and then, you know, you'll start to see limited access again. Because of that, we've seen some of that. The other thing that we've seen is a delay by patients, frankly, not wanting to go in and into the office, and then some short staffing that's happened, you know, in urologist office where they've had a delay or the hospitals have been full, and so they've stopped all elective surgery. We've seen that. Every week is a different week and every week things change. We remain confident because we know one, all the physicians that we've talked to that have used our product are happy. The anecdotal information that we get that we have seen we know we talk to physicians that they're excited about using it in the future. Hopefully things will continue to open up. Regardless, physicians and their offices are willing to talk to us and work with us. Patients can delay, but they can't delay forever. We know that these patients eventually have to come in. We know that, whether it's now or, again, maybe it's a little delayed, but what we've seen and how we've seen the adoption really increase over time, gives us confidence that this will become standard of care. Thank you, Liz. The other question we have is, I know the company just announced a new study design for UGN-102. Could you provide a little bit more information on that, including logistically the site setup? Yeah, no, it's a great question. What the good news is that it's a global study. We actually had over 100 sites already set up and were enrolling in the ATLAS study. We're able to actually take advantage of the fact that we've already had the logistics set up with these sites and just shifting. Now it's really a matter of just going through IRBs and getting, you know, those set up, which the team is doing as we speak. Of course, also we have the COVID situation where some hospitals and institutions may be a little bit slower in setting up, but we aren't concerned about our ability to eventually get them set up. Because we were on a really good track with enrolling patients in ATLAS. Physicians are excited about the fact that they believe this study is a better study. We're again just shifting those sites that were already set up to be set up for ENVISION. We will be able to enroll those 220 patients in this year, in 2022, and then we'll be up in follow-up mode from there. Thank you. It's great to see the company is diversifying to oncology. What are some of the partnership business development strategies or plans you have for the year? Yeah, it's great. As I've mentioned before, the good news is a lot of what we're doing is research collaborations with academic institutions that have different, like Johns Hopkins and Georgetown University, that they've identified different areas where they believe our technology can advance medicines and advance areas like GBM, like head and neck cancer that have been historically difficult to treat, and effective treatments have, you know, been, unfortunately, remiss in these areas. The belief is that our technology, the ability for that, for them to, combine that with different chemotherapies, different IO agents, put them into these tumors directly and be able to either reduce radiation or, become more effective because of it. That's one area. Another area is we also have had other companies that have been interested in utilizing the technology in areas outside of oncology. You know, we can't get into the details at the moment, but we've seen that as well. We've also seen you know, a university interested in using it more as a device in a surgical procedure. There's a lot of different avenues that we believe it takes. The business development group headed by Polly Murphy, whom I've worked with for many years, and she's you know, she's the one person that's heading that. You know, she's in touch with all of these academic institutions and other companies that are interested in leveraging our technology. Thank you. Let me just touch on a little bit on the finance part. What do you think of the runway, you know, supporting the clinical trials and the ongoing product commercial support? Yeah, it's a great question. Molly Henderson is our Chief Financial Officer. She thinks about this day and night. You know, what we've guided to before is that our current cash position will take us into 2023. She's looking at ways to ensure that we have what remain a strong balance sheet. Obviously, equity is tough right now because of the stock price. We've had a lot of pressure on our stock over the last few months, but we really believe that there are alternate ways to finance the company, and we feel very confident in that. We expect, you know, to be doing something over the next year. Cool. Can you provide some additional detail on the home installation study for UGN-102 that you announced last month? Yeah, sure. The purpose of the home installation, and I have to give a shout-out to our Chairman of the Board, Arie Belldegrun, who's also a urologist, by the way, because this was his idea. It was during COVID, and he's like, "You can give this at home. We need to do a study that demonstrating that you can do this at home." That's exactly what we did. The patient comes into the office for the first installation, obviously, so the physician can see the patient, they can make sure that everything's okay. They give the first installation, make sure there's no issues. We move to the home. A home health company actually goes to the patient's home and gives it. I spoke to our chief development officer yesterday, and anecdotally, she's gotten some very positive feedback from the patients who have actually had this delivered to them in their home. Again, you need a home health, you know, person to come into their home. Being able to do it at home gives us several things. One, it does tell us that if we are in a situation where you can't get to the doctor's office or you can't, then you can do it at home. It also just reflects the ease of use of UGN-102. We're not able to do that with JELMYTO because it's in the upper tract, so you need to be either, you know, in an office that has the right equipment. For UGN-102, you can actually easily give it in the home. Thank you very much. We'll stop there. Thanks, Liz, again for a great presentation and discussion. Thanks everyone for joining. Thank you. Thanks for having us. Take care.