UroGen CEO 'Very Surprised' As Rival Trials Drain Starts For Jelmyto, Now Guided To About $90 Million
Four or five companies are enrolling the same small patient pool, CEO Liz Barrett said, and the lost starts add up to several million dollars a year.
UroGen Pharma, which develops and sells treatments for urothelial and specialty cancers, is losing Jelmyto patients to competing clinical trials, CEO Liz Barrett said on the company's Wednesday third-quarter earnings call. The company now guides to about $90 million in full-year Jelmyto net product revenue.
Trials crowd a tiny patient pool
Barrett, UroGen's president and CEO, told analysts she was "very surprised" that about four or five companies are running studies in low-grade upper tract urothelial cancer, which has a "very limited patient population." She added that Jelmyto's heavy users "are also clinical trial sites."
On an annualized basis, she said, the lost starts come to "several million dollars of revenue," though she was "not saying that we would have gotten all of that." UroGen's own Phase III trial of UGN-104, its next-generation version, is among the studies competing for eligible patients, management said. Barrett said that trial should be fully enrolled soon, and that other trials will still weigh on Jelmyto in 2027.
She said UroGen chose to prioritize Zusduri, knowing Jelmyto could face challenges, and is building a "strike team" to keep promotional presence with heavy Jelmyto users.
Jelmyto slips as Zusduri carries the quarter
Jelmyto revenue was $21 million in the third quarter, against $22 million in the second. Chief Financial Officer Chris Degnan said the quarter included a one-time unfavorable adjustment of about $1.5 million tied to a federal discarded-drug provision true-up. He said the new full-year figure reflects that adjustment plus the trial-enrollment headwind. Barrett reiterated that Jelmyto is likely a $100 million to $150 million long-term opportunity.
Zusduri, UroGen's treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, generated $68 million in net product revenue, up 35% from the prior quarter. Total revenue was $89 million, against $27.5 million a year earlier. The net loss narrowed to $1.5 million, or $0.03 a share, from $33.3 million a year earlier.
UroGen held $90.5 million in cash, equivalents and marketable securities at quarter end. Degnan said the company expects to turn profitable and generate positive cash flow in the fourth quarter. It is keeping full-year operating expense guidance of $260 million to $270 million, now expecting the upper end.
UroGen is scheduled to present at the Guggenheim Securities healthcare conference on November 10.
Sources
- Earnings Beat Might Change The Case For Investing In UroGen Pharma (URGN) — Yahoo Finance
- Urogen Pharma (URGN) Reports Q3 Loss, Beats Revenue Estimates — Yahoo Finance
- UroGen expects profitability and positive cash flow in Q4 2026 as ZUSDURI grows 35% sequentially (NASDAQ:URGN) | Seeking Alpha — seekingalpha.com
- UroGen Reports $68.0 Million of ZUSDURI Revenue and — globenewswire.com
- UroGen Pharma to Present at the Guggenheim Securities 3rd — globenewswire.com
