UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript Summary
UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript Summary
UGN-102 NDA acceptance by the FDA ahead of the PDUFA target date of June 13, 2025.The following is a summary of the UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript:
以下是烏龍製藥有限公司（URGN）2024年第三季度業績會議電話摘要:
Financial Performance:
財務表現:
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.
烏龍製藥報告2024年第三季度淨產品收入爲2520萬美元，同比增長21%，主要受到JELMYTO強勁的潛在需求增長驅動。
儘管面臨來自從毛利到淨收入的壓力，但公司預計JELMYTO全年營收將實現低兩位數增長。
Business Progress:
業務進展：
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.
UGN-102的NDA獲得FDA批准，提前於2025年6月13日的PDUFA目標日期。
啓動UGN-103的UTOPIA試驗，該試驗與ENVISION試驗設計類似。
招募關鍵領導職位以強化UGN-102上市前的商業能力。
Opportunities:
機會：
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.
對醫療保健壓力位批准及發佈 UGN-102 作爲第一種 FDA 批准的低級中風險非肌肉侵襲性膀胱癌藥物，可能會對治療範式產生重大影響，並對公司具有轉型意義，擴大了可尋址市場。
公司計劃擴大銷售團隊並加強商業業務，以支持預計推出 UGN-102 的預期，預計由於相較於 JELMYTO 更易整合到現有門診工作流程中，將有更高的採納率。
Risks:
風險：
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.
正在進行爲預期的顧問委員會（ODAC）會議做準備工作，體現了專注於應對監管障礙並確保成功的藥物批准和發佈流程。
和 UGN-102 批准後計費的雜項 J 代碼相關的挑戰，可能會影響初始接受度。
Tips: For more comprehensive details, please refer to the IR website. The article is only for investors' reference without any guidance or recommendation suggestions.
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譯文內容由第三人軟體翻譯。
