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.
JELMYTO net product revenues reached a record $21.1 million in Q2 2023, representing a ~27% increase year-over-year.
ENVISION and ATLAS Phase 3 clinical trials of UGN-102 in LG-IR-NMIBC both met their primary endpoints.
A $120 million private placement of ordinary shares and pre-funded warrants strengthened the balance sheet.
The company anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024, assuming positive secondary endpoint findings.
The Company reiterates anticipated full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million. The Company also reiterates anticipated full year 2023 operating expenses in the range of $135 to $145 million, including non-cash share-based compensation expense of $6.0 to $11.0 million, subject to market conditions. The Company also reiterates anticipated 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. Of this amount approximately $9.9 to $11.2 million is expected to be in cash.