UroGen Pharma Ltd. (NASDAQ:URGN) Q3 2024 Earnings Call Transcript November 6, 2024 10:00 AM ET

Company Participants

Vincent Perrone - Head of IR
Liz Barrett - President and CEO
Mark Schoenberg - CMO
David Lin - CCO
Chris Degnan - CFO

Conference Call Participants

Tara Bancroft - TD Cowen
Ram Selvaraju - H. C. Wainwright & Co.
Leland Gershel - Oppenheimer
Kelsey Goodwin - Guggenheim
Matt Kaplan - Ladenburg Thalmann

Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the UroGen Pharma Third Quarter 2024 Earnings Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations. You may now begin.

Vincent Perrone

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's third quarter 2024 financial results and business update conference call. Earlier this morning we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended September 30, 2024. The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer.

During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to JELMYTO, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as future commercialization activities for UGN-102 if approved, anticipated data regulatory filings and decisions, UGN-102 being the growth driver for UroGen if approved, future R&D efforts, our corporate goals, and 2024 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements and your agenda disclaims any obligation to update these statements.

I'll now turn the call over to Liz Barret.

Liz Barrett

Thank you, Vincent, and thank you for joining us this morning. As we continue to innovate and pioneer new treatment paradigms in urothelial cancers, I'm excited to highlight the progress we've made with UGN-102, our groundbreaking therapy for low-grade intermediate-risk non-muscle invasive bladder cancer. Ahead of schedule, we successfully submitted the new drug application for UGN-102 in August and in October we were pleased to announce the FDA's acceptance of the NDA with a PDUFA target date of June 13, 2025. This milestone represents more than a regulatory achievement. It is a testament to the dedication of our team and a pivotal step toward our goal of changing how low-grade intermediate-risk non-muscle invasive bladder cancer is treated. Our regulatory and clinical teams are committed to working closely with the FDA during the review process as we move toward a potential approval.