UroGen Pharma’s Earnings Call: Growth Amid Challenges

Urogen Pharma ((URGN)) has held its Q3 earnings call. Read on for the main highlights of the call.

UroGen Pharma’s recent earnings call presented a balanced sentiment, highlighting significant progress in the launch of ZUSDURI and revenue growth for JELMYTO, while also addressing operational challenges and increased expenses. The anticipation of a permanent J-code for ZUSDURI is seen as a future growth catalyst, despite current concerns over operational delays and a notable increase in net loss.

ZUSDURI Launch Progress

The launch of ZUSDURI has shown promising signs, with preliminary demand revenue for October more than doubling the previous three months. This indicates a significant increase in usage and adoption. The enthusiasm among physicians remains high, and there is a strong intent to prescribe, supported by the market access team securing broad coverage across major payers.

JELMYTO Revenue Growth

JELMYTO has demonstrated solid revenue growth, with net product revenue reaching $25.7 million, marking a 13% increase in underlying demand revenue compared to the same period in 2024. This growth underscores the product’s strong market presence and acceptance.

Clinical Advancements

The UTOPIA study’s 3-month complete response rate aligns with previous trials, bolstering plans for an NDA submission for UGN-103 in the second half of 2026. This positions the company for potential approval in 2027, marking a significant step in their clinical development pipeline.

Strong Market Access for ZUSDURI

ZUSDURI has achieved remarkable market access, being accessible to 95% of covered lives, which translates to approximately 296 million eligible patients. This excellent progress in market access is a positive indicator for future growth.

Permanent J-code for ZUSDURI

The introduction of a permanent J-code for ZUSDURI, effective January 1, 2026, is expected to accelerate adoption, especially in community settings. This development is anticipated to facilitate smoother reimbursement processes and wider usage.

Slow Conversion of Patient Enrollment Forms

The company faces challenges with a 45- to 60-day lag between patient enrollment form submission and dosing, due to logistical and operational issues, including reimbursement complexities with a miscellaneous J-code.

UGN-301 Program Discontinuation

UroGen has decided to discontinue the UGN-301 program due to its overall clinical profile not warranting advancement to a Phase II study. This strategic decision allows the company to reallocate resources to more promising programs.

Increased Operating Expenses

Operating expenses have risen by $8.7 million year-over-year, driven primarily by commercial preparation for ZUSDURI and the expansion of the sales force. This increase reflects the company’s investment in future growth initiatives.

Net Loss Increase

The net loss for the third quarter of 2025 increased to $33.3 million, compared to $23.7 million in the same period in 2024. This increase is attributed to the higher operating expenses and ongoing investments in product launches.

Forward-Looking Guidance

UroGen Pharma’s forward-looking guidance highlights a promising outlook, with ZUSDURI expected to become a primary growth driver, targeting a $5 billion annual market and over $1 billion in peak revenue. JELMYTO’s 2025 net product revenues are projected to range between $94 million and $98 million, representing an 8% to 12% increase from 2024. The company remains focused on UGN-103 and UGN-501, with a robust cash reserve of $127.4 million as of September 30, 2025, supporting their confidence in achieving long-term growth and profitability.

In summary, UroGen Pharma’s earnings call reflects a balanced sentiment, with significant achievements in product launches and revenue growth, tempered by operational challenges and increased expenses. The company’s strategic focus on ZUSDURI and JELMYTO, along with strong market access and clinical advancements, positions it well for future growth, despite the current financial challenges.