UroGen Pharma Ltd. Ordinary Shares Wells Fargo 21st Annual Healthcare Conference

Thank you. Thank you for having us.

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.

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 10 times the size.

Sure. Chris, why don't you comment, and then I'll add.