UroGen reported a transformative fourth quarter marked by the initial commercial launch of ZUSDURI and steady growth for JELMYTO. The company successfully refinanced its debt to strengthen its balance sheet and is seeing accelerated physician adoption following the implementation of a permanent J Code for ZUSDURI in early 2026.
UroGen posted a net loss of $43.8 million in Q1 2025, with revenue increasing to $20.3 million due to continued demand for JELMYTO. However, higher operating costs tied to pipeline development and commercialization efforts weighed heavily on results.
UroGen's Q4 2024 revenue reached $24.6 million, reflecting a 5% year-over-year increase driven by higher JELMYTO demand. The company posted a net loss of $37.5 million due to increased R&D and SG&A expenses. JELMYTO continues to see growth in new patient starts and prescribers, and UroGen remains focused on advancing its UGN-102 NDA submission and pipeline assets.
UroGen Pharma reported JELMYTO net product revenues of $25.2 million for Q3 2024, compared to $20.9 million for Q3 2023. The FDA accepted the New Drug Application for UGN-102, with a PDUFA target action date set for June 13, 2025. As of September 30, 2024, the company had $254.2 million in cash, cash equivalents, and marketable securities.
UroGen Pharma reported JELMYTO net product revenues of $21.8 million for Q2 2024 and ended the quarter with $241.3 million in cash, cash equivalents, and marketable securities. The company is focused on completing the NDA submission for UGN-102 and preparing for its potential approval and launch.
UroGen Pharma reported Q1 2024 financial results, highlighted by JELMYTO net product revenues of $18.8 million, a 10% increase compared to Q1 2023. The company is advancing its pipeline, with UGN-102 nearing NDA completion and UGN-103's IND accepted by the FDA.
UroGen Pharma reported JELMYTO net product revenues of $23.5 million for Q4 2023, compared to $18.1 million for the same period in 2022. The company also initiated the submission of a rolling NDA to the FDA for UGN-102.
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.
UroGen Pharma reported record JELMYTO quarterly sales of $21.1 million, a ~27% increase from the same period last year. Both ENVISION and ATLAS Phase 3 trials of UGN-102 met their primary endpoints. The company also completed a $120 million private placement of ordinary shares and pre-funded warrants.
UroGen Pharma reported a net product revenue of $17.2 million for JELMYTO in Q1 2023, representing a ~27% increase compared to Q1 2022. The company is preparing for topline results from the ENVISION and ATLAS clinical trials and anticipates submitting an NDA for UGN-102 in 2024.
UroGen Pharma reported JELMYTO net product revenues of $18.1 million for Q4 2022, compared to $16.2 million for the same period in 2021. The company also completed enrollment of the ENVISION Phase 3 pivotal clinical trial for UGN-102 for LG-IR-NMIBC and anticipates topline data readout from the ATLAS clinical study and complete response from the ENVISION pivotal study in mid-year 2023.
UroGen Pharma reported its Q3 2022 financial results, highlighting a 41% increase in JELMYTO® net product revenue compared to the same period last year, reaching $16.1 million. The FDA authorized an extension of the in-use period for JELMYTO® admixture, and the company is progressing with its UGN-102 Phase 3 pivotal trial.
UroGen Pharma reported a net product revenue of $16.6 million for Q2 2022, a 28% increase year-over-year. The company is on track with its clinical development programs, including the UGN-102 Phase 3 trial and UGN-301 Phase 1 clinical trial. They are focused on reaching cash flow break-even in 2025 while strategically deploying capital.
UroGen Pharma reported first quarter 2022 financial results, highlighted by an 81% increase in Jelmyto net product revenue compared to Q1 2021, reaching $13.6 million. The company also progressed its clinical programs with the ongoing Phase 3 ENVISION trial for UGN-102 and the initiation of a Phase 1 clinical trial for UGN-301.
UroGen Pharma reported a net product revenue of $16.2 million for Q4 2021 from Jelmyto, representing a 42% increase over the previous quarter. The company also announced an up to $100 million senior secured term loan facility to support operations to reach cash flow breakeven by 2025.
UroGen Pharma reported Q3 2021 financial results, with Jelmyto net product revenue of $11.4 million, representing over 200% growth compared to Q3 2020. The company is initiating a new single-arm Phase 3 study of UGN-102 and is pleased with the strong demand for Jelmyto.
UroGen Pharma reported a net product revenue of $13.0 million for Jelmyto in the second quarter of 2021, representing a 70% growth over the first quarter. The company's Phase 3 ATLAS trial for UGN-102 continues to enroll patients, with nearly 100 global centers activated. UroGen also commenced Jelmyto geographic expansion efforts with a Neopharm license in Israel.
UroGen Pharma reported a net product revenue of $7.5 million for Jelmyto in Q1 2021. The company is progressing with its Phase 3 ATLAS trial and expanding its immuno-oncology pipeline through strategic collaborations. They also had a net loss of $25.9 million.
UroGen Pharma reported financial results for the fourth quarter and full year ended December 31, 2020. The company achieved Jelmyto net product revenue of $8.0 million for the fourth quarter. The Phase 3 ATLAS trial for UGN-102 was initiated and is actively enrolling patients.
UroGen Pharma reported Jelmyto net product revenue of $3.5 million in the third quarter of 2020, its first full quarter of commercialization. The company's research and development expenses were $10.2 million, and SG&A expenses were $22.1 million. UroGen reported a net loss of $28.8 million, or $1.31 per share, and cash and cash equivalents totaled $125.5 million as of September 30, 2020.
UroGen Pharma reported net product sales of Jelmyto of approximately $371,500 for the second quarter ended June 30, 2020. The company's cash, cash equivalents and marketable securities totaled $151.6 million as of June 30, 2020.