UroGen Pharma Ltd. (NASDAQ:URGN) Q2 2024 Earnings Call August 13, 2024 10:00 AM ET

Company Participants

Vincent Perrone - Head, Investor Relations
Liz Barrett - President and Chief Executive Officer
Mark Schoenberg - Chief Medical Officer
David Lin - Chief Commercial Officer
Dong Kim - Chief Financial Officer

Conference Call Participants

Tara Bancroft - TD Cowen
Raghuram Selvaraju - H.C. Wainwright & Co.
Leland Gershell - Oppenheimer
Kelsey Goodwin - Guggenheim Securities
Matt Kaplan - Ladenburg Thalmann
Paul Choi - Goldman Sachs

Operator

Good day and thank you for standing by. Welcome to the 2024 Second Quarter UroGen Pharma Earnings Call. [Operator Instructions] Please advise that today’s conference is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Head of Investor Relations. Please go ahead.

Vincent Perrone

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma’s second 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 June 30, 2024. The press release can be accessed on the Investors portion of our website at investors.urogen.com.

Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Dong Kim, 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 expectation as well as potential future commercialization activities for UGN-102 if approved, anticipated data, regulatory filings and decisions, including UGN-102 potentially receiving priority review, UGN-102 being a primary growth driver for UroGen if approved, future research and development 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 the latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements.

I’ll now turn the call over to Liz Barrett, President and CEO. Liz?

Liz Barrett

Thank you, Vincent and thank you for everyone joining this morning. The clear highlight of the second quarter was from our lead product candidate, our announcement of positive 12-month duration of response data from the ENVISION study evaluating UGN-102 in patients with low-grade intermediate risk, non-muscle invasive bladder cancer. We previously announced a compelling complete response rate of 79.6% at 3 months. The durability data showed that for those patients who had achieved a CR at 3 months, the duration of response was an unprecedented 82.3% at 12 months by Kaplan-Meier analysis. This is the highest duration of response ever reported in this patient population.