财务数据和关键指标变化 - 第一季度JELMYTO销售收入为1880万美元,同比增长约10% [39][40] - 成本收入从2023年同期的230万美元下降到170万美元,主要由于供应协议相关的非经常性支付减少、混合费用下降以及JELMYTO单位成本下降 [51] - 研发费用从2023年同期的1250万美元增加到1550万美元,主要由于UGN-102相关的监管费用以及UGN-103 III期试验启动相关费用 [52] - 销售、一般及管理费用从2023年同期的2450万美元增加到2730万美元,主要由于UGN-102品牌营销费用增加 [53] - 利息费用从2023年同期的360万美元下降到240万美元,主要由于贷款利率下降和相关折扣摊销减少 [54] - 第一季度净亏损为3230万美元,每股亏损0.97美元,而2023年同期为3020万美元,每股亏损1.30美元 [54] - 截至3月31日,公司现金、现金等价物和可流通证券余额为1.645亿美元 [55] 各条业务线数据和关键指标变化 - JELMYTO业务: - 第一季度销售收入为1880万美元,同比增长约10% [39][40] - 患者登记表数量创历史新高,表明需求持续增长 [16] - 公司发布了OLYMPUS试验的长期随访数据,显示JELMYTO可提供长期无复发期 [23][24][25] - UGN-102业务: - 预计将于2025年初上市,公司正在进行预商业化准备 [42] - ATLAS试验数据显示UGN-102可延长无复发生存期和缓解持续时间,优于TURBT手术 [26][27][28] - 公司计划于2024年底启动UGN-103的III期试验,并随后启动UGN-104的III期试验 [35] - 免疫肿瘤业务: - UGN-301(抗CTLA-4抗体)正在I期试验,预计2024年底前公布安全性和耐受性数据 [36][37] - 公司正在评估UGN-301联合其他药物(如gemcitabine和UGN-201)的组合疗法 [37] 各个市场数据和关键指标变化 - 公司预计UGN-102的总市场规模约为JELMYTO市场规模的10倍,即超过30亿美元 [11][12] - 公司计划针对UGN-102寻求广泛适应症,预计初期采用最快的采用率将来自以下三类患者群体: [48] 1) 复发多次的患者 2) 手术失败的患者 3) 不适合或不愿接受手术的患者 公司战略和发展方向及行业竞争 - 公司正在积极推进UGN-102、UGN-103和UGN-104等新产品的开发,以拓展泌尿肿瘤业务 [14][15][35] - UGN-103和UGN-104是UGN-102和JELMYTO的下一代产品,有望获得更长的专利保护期 [14][15] - 公司正在评估将UGN-102用于高级别非肌层浸润性膀胱癌的可能性 [115] - 公司正在广泛评估各种化疗药物和靶向药物,包括与公司CTLA-4抑制剂UGN-301的组合疗法,以拓展产品管线 [112][113][114][115] 管理层对经营环境和未来前景的评论 - 公司对UGN-102的上市前景充满信心,认为其将大幅改善低级别中危非肌层浸润性膀胱癌患者的治疗方案 [11][12][13][34] - 管理层预计UGN-102的采用速度将快于JELMYTO,因为目标医生群重叠度高,且UGN-102更易于操作 [61][62][127][128][129] - 公司认为UGN-102的临床数据和创新给药方式将推动广泛采用,并有望成为公司未来的主要增长动力 [11][12][13][44] - 公司有信心凭借现有资金实现预期的运营和商业化计划,无需额外融资 [18][19] 问答环节重要的提问和回答 问题1 **Tara Bancroft 提问** 您能否告知UGN-102预期初期采用最快的三类患者群体的大致规模,以及哪一类可能是采用最快的? [59] **Jeff Bova 回答** - 不适合或不愿接受手术的患者约占10%-15% [61] - 5次或更多次复发的患者约占25% [62] - 6-9个月内复发的患者约占25% [62] 这三类患者群体将是UGN-102最初采用最快的 [63][64] 问题2 **Raghuram Selvaraju 提问** 关于UGN-102的定价,您是否看到有上调空间?哪些因素可能影响定价? [68] 另外,UGN-102是否会获得J编码,以及公司目前的销售团队规模及扩充计划如何? [68][69] **Elizabeth Barrett 回答** - 我们确实看到了定价上调的空间,特别是在6月份公布的数据后 [71] - J编码方面,UGN-102会像JELMYTO一样获得永久性J编码,公司将使用临时编码直至获批 [73] - 目前公司有7个大区,45名业务经理,未来会增加1个大区,新增10-15名销售代表 [74] 问题3 **Leland Gershell 提问** 之前公司提到过50%的完全缓解率作为UGN-102的目标,但实际数据似乎要好于此。您如何解释这一目标值,以及如何看待与之前提到的医生和患者的高度认可度? [99][100] 另外,公司是否在研究将其他化疗药物如gemcitabine纳入凝胶制剂中? [109] **Mark Schoenberg 回答** - 50%只是之前的预测目标,实际ATLAS试验的复发患者12个月无复发率为66%,这更符合公司的预期 [104][105] -

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38079 UROGEN PHARMA LTD. (Exact Name of Registrant as Specified in its Charter) Israel 98-1460746 (State or other jurisdiction of ...

Exhibit 99.1 UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights • 12-month duration of response data from ENVISION study of UGN-102 to be discussed during company sponsored virtual event on June 13, 2024 • ENVISION data expected to support completion of UGN-102 NDA in Q3 2024 • Post-hoc analysis of OLYMPUS study for JELMYTO shows disease-free periods more than 47.8 months in LG-UTUC • JELMYTO® demons ...

UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2023 Earnings Conference Call March 14, 2024 10:00 AM ET Company Participants Vincent Perrone - Head of IR Elizabeth Barrett - President and CEO Mark Schoenberg - Chief Medical Officer Dong Kim - CFO Jeffrey Bova - Chief Commercial Officer Silvio Pacheco - VP of Market Access Conference Call Participants Tara Bancroft - TD Cowen Leland Gershell - Oppenheimer Paul Choi - Goldman Sachs Matt Kaplan - Ladenburg Thalmann Operator Good morning, ladies and gentlemen. Thank you f ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____________ to ________________ Commission file number: 001-38079 UROGEN PHARMA LTD. (Exact name of registrant as specified in its charter) Isra ...

Exhibit 99.1 UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102 • Initiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission • Announced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs from medac GmbH licensing agreement with potential IP protection until December 2041 • J ...

Urogen Pharma Ltd (NASDAQ:URGN) Q3 2023 Earnings Conference Call November 14, 2023 10:00 AM ET Company Participants Vincent Perrone - Senior Director, IR Elizabeth Barrett - President, CEO & Director Mark Schoenberg - Chief Medical Officer Dong Kim - CFO Jeffrey Bova - Chief Commercial Officer Conference Call Participants Leland Gershell - Oppenheimer Raghuram Selvaraju - H.C. Wainwright & Co. Boris Peaker - TD Cowen Paul Choi - Goldman Sachs Group Operator Good morning, ladies and gentlemen, and thank you ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38079 UROGEN PHARMA LTD. (Exact Name of Registrant as Specified in its Charter) Israel 98-1460746 (State or other jurisdictio ...

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 gentle ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38079 UROGEN PHARMA LTD. (Exact Name of Registrant as Specified in its Charter) Israel 98-1460746 (State or other jurisdiction of ...