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EX - 99.1 2 d191765dex991.htm EX - 99.1 Exhibit 99.1 UroGen Pharma UroGen Pharma Reports Second Quarter 2021 Financial Results and Recent Corporate Developments Strong JelmytoⓇ net product revenue of $ 13.0 million for the second quarter of 2021 , representing more than 70 % growth over the first quarter of 2021 • Nearly 100 global centers activated for Phase 3 landmark ATLAS trial with lead pipeline candidate , UGN - 102 • Commenced Jelmyto geographic expansion efforts with Neopharm license in Israel Conference call and webcast to be held today at 8:30 AM ET PRINCETON , N.J. , August 4 , 2021 - UroGen Pharma Ltd. ( Nasdaq : URGN ) , a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases , today announced financial results for the second quarter ended June 30 , 2021 , and provided an overview of the Company's recent developments . “ At UroGen , every day we are working towards our goal of fundamentally changing the way urologic cancers are treated because we believe patients deserve better options than invasive or repetitive surgeries to treat chronic recurrences , " said Liz Barrett , President and Chief Executive Officer of UroGen . “ Jelmyto was the first of our product candidates to demonstrate this paradigm - shift towards more innovative therapies . Our strong revenue in the second quarter reinforces our belief in the value of this novel treatment for adult patients suffering from low - grade upper tract urothelial cancer . This provides a strong foundation and clear proof of concept of the power of our platform and reinforces our commitment to revolutionizing the treatment of urologic cancers globally while we advance our pipeline in critical areas of uro - oncology and specialty cancers . " Business Highlights : Jelmyto ( mitomycin ) for pyelocalyceal solution : UroGen achieved net product revenue of $ 13.0 million for the second quarter of 2021 , representing more than 70 % growth over the first quarter of 2021. Net product revenue was $ 20.5 million for the first half of 2021 . As of August 1 , 2021 , 407 sites have been activated , which means they have completed their internal processes and have treated or are ready to treat patients . This represents a 29 % increase since May 1 , 2021 . Sites that have treated more than one patient as of August 1 , 2021 , increased to 63 , compared to 40 as of May 1 , 2021 : an increase of approximately 58 % . UGN - 102 ( mitomycin ) for intravesical solution : ATLAS , the pivotal Phase 3 trial of UGN - 102 , continues to enroll patients with low - grade intermediate risk non - muscle invasive bladder cancer ( LG - IR - NMIBC ) with nearly 100 sites activated in the U.S. , Europe and Israel . Today , patients are treated with repetitive surgical intervention , and this trial has the potential to demonstrate that a therapeutic treatment can be as effective , if not more effective , than a surgical intervention . The ATLAS trial is expected to enroll approximately 630 patients and is the first of its kind , evaluating UGN - 102 as a primary non - surgical treatment compared to standard of care – transurethral resection of bladder tumor ( TURBT ) – in adult patients diagnosed with LG - IR - NMIBC . -