Sep 30, 2023

UroGen Q3 2023 Earnings Report

UroGen reported strong JELMYTO® growth and progress with UGN-102 NDA submission.

Key Takeaways

UroGen Pharma reported JELMYTO® net product revenues of $20.9 million in Q3 2023, representing approximately 30% growth compared to the same period last year. The company is also preparing for a rolling NDA submission for UGN-102, planned for January 2024.

JELMYTO® net product revenues reached $20.9 million in Q3 2023, a ~30% increase year-over-year.

Agreement reached with the FDA to proceed with a rolling NDA for UGN-102, starting in January 2024.

ENVISION and ATLAS Phase 3 clinical trials met their primary endpoints in treating LG-IR-NMIBC.

Cash, cash equivalents and marketable securities totaled $153.9 million as of September 30, 2023.

Total Revenue
$20.9M
Previous year: $16.1M
+29.5%
EPS
-$0.68
Previous year: -$1.13
-39.8%
Gross Profit
$18.5M
Previous year: $14.1M
+31.3%
Cash and Equivalents
$154M
Previous year: $95.9M
+60.5%
Free Cash Flow
-$17.4M
Previous year: -$17.8M
-2.1%
Total Assets
$194M
Previous year: $128M
+50.7%

UroGen

UroGen

UroGen Revenue by Segment

Forward Guidance

UroGen Pharma provided full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million.

Positive Outlook

  • Full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million.
  • Full year 2023 operating expenses in the range of $135 to $145 million.
  • Non-cash share-based compensation expense of $6.0 to $11.0 million, subject to market conditions.
  • Full year 2023 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21.0 to $26.0 million.
  • Approximately $9.9 to $11.2 million is expected to be in cash.