UroGen Pharma Ltd (URGN) Reports Growth in Q3 Revenue and Progress in Clinical Trials
UroGen Pharma Ltd (NASDAQ:URGN) announces a 29.8% increase in net product revenue from JELMYTO in Q3 2023 compared to Q3 2022.
Research and development expenses decreased to $10.2 million in Q3 2023 from $13.1 million in the same period last year.
Net loss improved to $21.9 million in Q3 2023, down from $25.8 million in Q3 2022.
Company reiterates full-year 2023 revenue guidance, expecting JELMYTO net product revenues to be in the range of $76 to $86 million.
On November 14, 2023, UroGen Pharma Ltd (NASDAQ:URGN) released its 8-K filing, detailing the financial results for the third quarter ended September 30, 2023. The company, which specializes in innovative treatments for urothelial and specialty cancers, reported a significant increase in net product revenue and shared updates on its clinical trial progress.
Financial Performance and Highlights
URGN's net product revenue for JELMYTO, its treatment for low-grade upper tract urothelial cancer (LG-UTUC), reached $20.9 million in Q3 2023, marking a 29.8% increase from $16.1 million in the same quarter of the previous year. This growth reflects the company's continued commercial success with JELMYTO.
Research and development expenses saw a decrease to $10.2 million in the third quarter of 2023, down from $13.1 million in Q3 2022. This reduction is partly due to a decrease in non-cash share-based compensation expense. Selling, general, and administrative expenses increased slightly to $21.8 million in Q3 2023 from $19.1 million in the same period last year.
URGN reported a net loss of $21.9 million, or $0.68 per share, for the third quarter of 2023, which is an improvement from a net loss of $25.8 million, or $1.13 per share, in Q3 2022. The company's cash and cash equivalents, including marketable securities, totaled $153.9 million as of September 30, 2023.
Clinical Development and Future Outlook
URGN highlighted significant milestones in its clinical development, particularly the positive results from the ENVISION and ATLAS Phase 3 trials of UGN-102 for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Liz Barrett, President and CEO of UroGen, expressed optimism about the potential approval of UGN-102, which could be the first medicine approved for this patient population.
The company reiterated its full-year 2023 guidance, expecting net product revenues from JELMYTO to be in the range of $76 to $86 million. Operating expenses are anticipated to be between $135 to $145 million, including non-cash share-based compensation expense of $6.0 to $11.0 million.
Balance Sheet and Income Statement Summary
URGN's balance sheet shows total assets of $193.6 million and total liabilities of $235.6 million, resulting in a shareholders' deficit of $42.0 million. The condensed consolidated statements of operations reveal a gross profit of $18.5 million for the third quarter, with total operating expenses amounting to $31.9 million. The operating loss stood at $13.5 million for the quarter.
In summary, UroGen Pharma Ltd (NASDAQ:URGN) has demonstrated a solid financial performance in the third quarter of 2023, with increased revenue from its flagship product JELMYTO and a reduction in net loss compared to the previous year. The company's clinical advancements and alignment with the FDA on a rolling NDA review for UGN-102 signal a strong commitment to addressing unmet medical needs in urothelial cancers. Investors and stakeholders can look forward to potential growth and product approvals in the coming year.
Explore the complete 8-K earnings release (here) from UroGen Pharma Ltd for further details.
This article first appeared on GuruFocus.
