-
Jelmyto Sales: $20.3 million in Q1 2025, 8% year-over-year growth.
-
Revenue Growth: Driven by 12% underlying demand growth.
-
R&D Expenses: $19.9 million in Q1 2025, up from $15.5 million in Q1 2024.
-
SG&A Expenses: $35 million in Q1 2025, up from $27.3 million in Q1 2024.
-
Net Loss: $43.8 million or $0.92 per share in Q1 2025, compared to $32.3 million or $0.87 per share in Q1 2024.
-
Cash Equivalents and Marketable Securities: $200.4 million as of March 30, 2025.
-
Full Year 2025 Jelmyto Revenue Guidance: $94 million to $98 million.
-
Full Year 2025 Operating Expenses Guidance: $215 to $225 million.
Release Date: May 12, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
-
UGN-102 is in the final stages of FDA review with a PDUFA target date of June 13, indicating potential near-term approval.
-
The ENVISION trial showed an 80.6% complete response rate at 18 months, highlighting the drug’s efficacy.
-
UGN-102 is expected to be a primary growth driver, with a market opportunity of over $5 billion, significantly larger than the Jelmyto market.
-
UroGen Pharma Ltd (NASDAQ:URGN) is expanding its sales force from 50 to over 80 reps in anticipation of UGN-102’s launch.
-
The company has a strong balance sheet with over $200 million in cash equivalents and marketable securities as of March 31, 2025.
-
UGN-102’s approval is based on a single-arm study, which may raise concerns about the comparability of results.
-
The company reported a net loss of $43.8 million for the first quarter of 2025, an increase from the previous year.
-
R&D expenses increased due to higher manufacturing costs and costs associated with the Phase 3 utopia trial for UGN-103.
-
The gross-to-net rate for Jelmyto has been a headwind, although it is expected to stabilize.
-
The company anticipates a temporary miscellaneous J-code for UGN-102, which may impact initial adoption rates.
Q: Can you provide a breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto, and how do you anticipate pricing dynamics to play out? A: Elizabeth Barrett, CEO, mentioned that UroGen is a US-focused company, so there are no international pricing concerns. David Lin, Chief Commercial Officer, added that Medicare is expected to comprise about 70% of their business, consistent with the patient demographic for low-grade intermediate risk NMIBC. The priority is to drive reimbursement confidence with providers.
Q: How are you preparing for the ODAC meeting, and where do you expect the most pushback from the panel? A: Elizabeth Barrett, CEO, explained that they have been preparing for the ODAC meeting for months with mock panels and expert input. The main challenge is the single-arm study design of ENVISION, which lacks comparative data. However, they feel confident due to the strong clinical results and have received positive feedback in their mock ODAC sessions.
