The following is a summary of the UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript:

Financial Performance:

• UroGen Pharma reported Q3 2024 net product revenues of $25.2 million, a 21% year-over-year increase, primarily driven by strong underlying demand growth for JELMYTO.

• The company expects full-year JELMYTO revenues to deliver low double-digit growth despite challenges from gross-to-net headwinds.

Business Progress:

• UGN-102 NDA acceptance by the FDA ahead of the PDUFA target date of June 13, 2025.

• Initiation of the UTOPIA trial for UGN-103, which follows a similar design to the ENVISION trial.

• Recruitment of key leadership positions to strengthen the commercial capabilities ahead of UGN-102 launch.

Opportunities:

• The potential approval and launch of UGN-102 as a first FDA-approved medicine for low-grade intermediate-risk non-muscle invasive bladder cancer could significantly impact the treatment paradigm and be transformative for the company, expanding the addressable market.

• The company plans to expand the sales force and enhance commercial operations to support the anticipated launch of UGN-102, which is expected to have a higher adoption due to easier integration into existing outpatient workflows compared to JELMYTO.

Risks:

• Ongoing preparatory measures for an anticipated advisory committee (ODAC) meeting, reflecting a focus on navigating regulatory hurdles and ensuring successful drug approval and launch processes.

• Challenges associated with miscellaneous J codes for billing UGN-102 upon approval, potentially affecting initial uptake.

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