UroGen Q3 JELMYTO revenue $20.9M (+30% YoY); FDA agrees to rolling NDA for UGN-102

UroGen Pharma Ltd.

JELMYTO net product revenue $20.9M in Q3 2023, up ~30% from $16.1M in Q3 2022.
FDA agreed to rolling NDA for UGN-102 in LG-IR-NMIBC starting Jan 2024; ENVISION trial showed 79.2% CRR at 3 months.
Net loss improved to $21.9M ($0.68/sh) from $25.8M ($1.13/sh) in Q3 2022.
Cash and marketable securities $153.9M as of Sep 30, 2023; FY 2023 revenue guidance reiterated at $76-86M.
ATLAS trial met primary endpoint; 55% reduction in risk of recurrence/progression/death.

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

UroGen Pharma Ltd. reported the third quarter ended September 30, 2023 results: revenue $20.9 million, net income a net loss of $21.9 million, EPS basic and diluted net loss per ordinary share of $0.68. Guidance reaffirmed.

Period: the third quarter ended September 30, 2023
Revenue: $20.9 million
Net income: a net loss of $21.9 million
EPS: basic and diluted net loss per ordinary share of $0.68
Guidance: reaffirmed
Result: reported results

Exact text from the filing

--- EX-99.1 (EX-99.1) --- EX-99.1 Exhibit 99.1 UroGen Pharma Reports Third Quarter 2023 Financial Results • Continued strong growth with JELMYTO ® net product revenues of $20.9 million in Q3 2023; an increase of ~30% from the same period last year • Agreement with United States Food & Drug Administration (FDA) to proceed with rolling New Drug Application (NDA)

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Source: SEC EDGAR

accession 0001193125-23-276676

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