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UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript Summary

UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript Summary

烏龍製藥有限公司(URGN)2024年第三季度業績會議電話交流摘要
富途資訊 ·  06:21  · 電話會議

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。


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