UroGen Pharma Ltd. (NASDAQ:URGN) Q2 2023 Results Conference Call August 10, 2023 10:00 AM ET

Company Participants

Vincent Perrone - Head Investor Relations

Liz Barrett - President and Chief Executive Officer

Mark Schoenberg - Chief Medical Officer

Jeff Bova - Chief Commercial Officer

Don Kim - Chief Financial Officer

Conference Call Participants

Raghuram Selvaraju - H.C. Wainwright

Boris Peaker - TD Cowen

Leland Gershell - Oppenheimer

Matt Kaplan - Ladenburg Thalmann

Operator

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the UroGen Pharma’s Second Quarter 2023 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 Investor Relations. You may begin.

Vincent Perrone

Thank you. Good morning, everyone. And welcome to UroGen Pharma's second quarter 2023 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and preliminary financial results for the quarter ended June 30, 2023. The press release can be accessed on the Investors portion of our Web site at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; Jeff Bova, Chief Commercial Officer; and Don 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 the foundry growth driver for UroGen if approved, future research and development efforts, our corporate goals and 2023 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 UroGen disclaims any obligation to update these statements.

I will now turn the call over to Liz. Liz?

Liz Barrett

Thank you, Vincent. And thank you to everyone joining us today. I'm excited to speak to you during what I can only describe as a transformative time for UroGen. UroGen is committed to revolutionizing patient care by developing and commercializing novel therapies, targeting urothelial and specialty cancers for patients that deserve better. We recently announced unprecedented results from two Phase 3 clinical trials, investigating the use of UGN-102 to treat patients with low grade intermediate risk non-muscle invasive bladder cancer. Both the ATLAS and ENVISION trials met their primary endpoints demonstrating meaningful and consistent results overall and relative to TURBT. In the ATLAS trial, UGN-102 met its primary endpoint of disease free survival, reducing risk of recurrence progression or death by 55%. Disease free survival 15 months after randomization was estimated to be 72% for patients in the UGN plus or minus TURBT arm compared to 50% for patients in the TURBT arm by Kaplan-Meier analysis. UGN-102 also showed a 65% complete response rate at three months for patients who only received UGN-102 compared to a 64% complete response rate at three months for patients who only received a TURBT. The ENVISION trial also met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of complete response at three months following the initiation of treatment. UGN-102 has now demonstrated consistent and what we believe compelling therapeutic and safety profile across multiple clinical trials, while showcasing the limitations of TURBT in this patient population.