UroGen Pharma Announces Q3 2024 Financials and UGN-102 Launch Plans for 2025

UroGen Pharma Ltd., a biotechnology company focused on developing innovative treatments for urothelial and specialty cancers, has reported its financial outcomes for the third quarter ending September 30, 2024, alongside updates on its recent progress. Liz Barrett, President and CEO, highlighted the FDA's recent acceptance of the company's New Drug Application (NDA) for UGN-102 as a significant step toward offering groundbreaking treatments for patients. UGN-102 aims to redefine the treatment landscape for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) by reducing the need for repetitive surgeries and offering longer treatment-free intervals. The FDA's decision on UGN-102 is expected by June 13, 2025, and if approved, it could represent a market opportunity exceeding $5 billion.

In October 2024, the FDA accepted UroGen's NDA for UGN-102 for intravesical solution, intended for treating LG-IR-NMIBC. The NDA is backed by comprehensive clinical trials demonstrating a robust complete response rate and an impressive duration of response, alongside an acceptable safety profile. The Phase 3 ENVISION trial showed a 79.6% complete response rate at three months post-treatment initiation. Moreover, the trial indicated an 82.3% 12-month duration of response, marking the highest recorded in this patient group. The safety profile aligns with observations from previous clinical trials.

UroGen's product JELMYTO, aimed at treating low-grade upper tract urothelial cancer (LG-UTUC), generated $25.2 million in net product revenue in the third quarter of 2024, up from $20.9 million in the same period in 2023. This revenue growth was primarily driven by increased demand and non-patient purchases.

In another development, UroGen initiated the Phase 3 UTOPIA clinical trial for UGN-103, a next-generation mitomycin-based formulation, in October 2024. UGN-103 combines UroGen’s RTGel technology with a novel mitomycin formulation and is planned to follow UGN-102's potential FDA approval and market launch. Additionally, UroGen received a Notice of Allowance for a patent application covering UGN-103’s use in treating LG-IR-NMIBC, with the patent expected to expire in December 2041.

On the corporate front, UroGen appointed Chris Degnan as the Chief Financial Officer in October 2024. Degnan brings extensive experience in financial strategy, investor relations, and compliance, having served in similar roles at Galera Therapeutics and Verrica Pharmaceuticals.

For the third quarter of 2024, UroGen reported JELMYTO net product revenues of $25.2 million compared to $20.9 million in the same period in 2023. Research and development expenses amounted to $11.4 million, up from $10.2 million in the third quarter of 2023. Selling, general, and administrative expenses were $28.9 million, an increase from $21.8 million in 2023. The company reported a net loss of $23.7 million or $0.55 per share, compared to a net loss of $21.9 million or $0.68 per share in the same period in 2023. As of September 30, 2024, UroGen's cash, cash equivalents, and marketable securities totaled $254.2 million.

Looking ahead, UroGen expects its full-year revenues for JELMYTO to be below the low end of the previously provided guidance range but anticipates low double-digit year-over-year revenue growth for 2024. Operating expenses are expected to align with the midpoint of the guidance range, including non-cash share-based compensation expenses. The anticipated non-cash financing expense related to the prepaid obligation to RTW Investments remains unchanged and is expected to be between $21 and $26 million.

UGN-102, currently under FDA review, is a novel mitomycin formulation designed to enhance bladder tissue exposure duration, offering a non-surgical treatment option for LG-IR-NMIBC. The market for UGN-102, if approved, is estimated at around $5 billion in the U.S.

UroGen Pharma, headquartered in Princeton, NJ, and with operations in Israel, is dedicated to providing innovative cancer treatment solutions, utilizing its RTGel technology to improve drug therapeutic profiles and efficacy.