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01/11 11:15
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents mixed signals. Financial performance shows increased expenses and losses, while product development highlights potential growth with new launches and trials. However, the Q&A reveals delays and uncertainties in revenue recognition and adoption, impacting short-term expectations. The lack of clear guidance on demand and revenue timelines, coupled with financial losses, outweighs the positive aspects, leading to a negative sentiment.
JELMYTO net product revenue $25.7 million, representing a 13% increase in underlying demand revenue over the same period in 2024. The increase was driven by both price favorability and volume growth.
ZUSDURI sales $1.8 million during the third quarter of 2025. Preliminary demand revenue estimate for October was $4.5 million, reflecting early momentum in Q4.
Total revenues $27.5 million, consisting of $25.7 million in JELMYTO sales and $1.8 million in ZUSDURI sales.
R&D expenses $14 million in the third quarter of 2025, compared to $11.4 million in the same period in 2024. The increase of $2.6 million was primarily driven by costs associated with the Phase III UTOPIA trial for UGN-103.
Selling, general and administrative expenses $37.6 million in the third quarter of 2025, compared to $28.9 million in the same period in 2024. The increase of $8.7 million was primarily driven by ZUSDURI commercial preparation activities and the expansion of the sales force.
Noncash financing expense $4.6 million in the third quarter of 2025, compared to $5.9 million in the same period in 2024.
Interest expense $3.4 million in the third quarter of 2025, compared to $2.7 million in the same period in 2024. The increase was primarily driven by interest expense related to the third tranche of the loan funded in September 2024.
Net loss $33.3 million or $0.69 per basic and diluted share in the third quarter of 2025, compared to a net loss of $23.7 million or $0.51 per basic and diluted share in the same period in 2024.
Cash, cash equivalents and marketable securities $127.4 million as of September 30, 2025.
ZUSDURI: Preliminary demand revenue for October doubled compared to the previous 3 months. Physician enthusiasm is high, and the product addresses a $5 billion annual market. Expected to deliver over $1 billion in peak revenue. Adoption is expected to accelerate with a permanent J-code effective January 1, 2026.
JELMYTO: Net product revenue of $25.7 million in Q3 2025, a 13% increase over the same period in 2024. Continues to demonstrate clinical value and prescriber confidence. Expanded field team to drive further growth.
UGN-103: Phase III UTOPIA study showed a 3-month complete response rate of 77.8%. NDA submission planned for the second half of 2026 with potential approval in 2027.
UGN-301: Phase I study completed, but the program is discontinued due to lack of advancement potential. Resources will be redirected to UGN-103 and UGN-501.
Market Access for ZUSDURI: Achieved broad accessibility through commercial, Medicare, and Medicaid insurance programs, covering over 95% of eligible patients. Nearly 600 sites activated for ZUSDURI.
Sales Force Expansion: Onboarded 30 new sales representatives, bringing the total to 82, with approximately 130 customer-facing professionals supporting ZUSDURI and JELMYTO.
Operational Challenges for ZUSDURI: Delays in patient dosing due to logistical and reimbursement challenges. Efforts underway to streamline workflows and reduce conversion time from patient enrollment to treatment.
Discontinuation of UGN-301: Strategic decision to discontinue UGN-301 program and focus resources on UGN-103 and UGN-501.
UGN-501 Development: IND-enabling studies ongoing with a Phase I trial planned for 2026. Designed to selectively destroy cancer cells and trigger a robust immune response.
ZUSDURI launch challenges: The uptake of ZUSDURI has been slower than expected due to logistical and operational challenges, including reimbursement concerns with a temporary miscellaneous J-code. This has caused delays in converting patient enrollment forms to actual treatments.
Operational readiness and site activation: Although nearly 600 sites are activated and ready to order and administer ZUSDURI, activation does not necessarily mean patients are being treated. There is a lag of 45-60 days between patient enrollment and dosing, particularly in hospital settings where formulary and P&T approvals extend timelines.
Temporary J-code complexity: The use of a temporary miscellaneous J-code for ZUSDURI has added administrative complexity, particularly for community practices, delaying broader adoption. A permanent J-code will only be available starting January 1, 2026.
High operating expenses: Selling, general, and administrative expenses increased significantly year-over-year, driven by ZUSDURI commercial preparation activities and sales force expansion, which could strain financial resources.
R&D cost pressures: R&D expenses increased due to costs associated with the Phase III UTOPIA trial for UGN-103, adding financial pressure.
Discontinuation of UGN-301 program: The UGN-301 program was discontinued due to an insufficient clinical profile to warrant advancement, representing a setback in the company's pipeline and resource allocation.
Net loss and financial strain: The company reported a net loss of $33.3 million for the third quarter of 2025, an increase from the previous year, indicating ongoing financial challenges.
ZUSDURI Adoption and Revenue Projections: The company expects an acceleration in ZUSDURI adoption once the permanent product-specific J-code goes into effect on January 1, 2026. ZUSDURI addresses an estimated $5 billion annual market, with long-term potential to deliver over $1 billion in peak revenue.
UGN-103 NDA Submission and Approval: The company plans to submit a New Drug Application (NDA) for UGN-103 in the second half of 2026, with potential approval anticipated in 2027.
UGN-501 Phase I Trial: A Phase I trial for UGN-501 in recurrent non-muscle invasive bladder cancer is planned for initiation in 2026.
JELMYTO Revenue Guidance: The company expects 2025 JELMYTO net product revenues to be in the range of $94 million to $98 million, implying year-over-year growth of approximately 8% to 12% over 2024.
Operational Expense Guidance: Full-year 2025 operating expenses are expected to be in the range of $215 million to $225 million, including noncash share-based compensation expense of $11 million to $14 million.
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The earnings call presents mixed signals. Financial performance shows increased expenses and losses, while product development highlights potential growth with new launches and trials. However, the Q&A reveals delays and uncertainties in revenue recognition and adoption, impacting short-term expectations. The lack of clear guidance on demand and revenue timelines, coupled with financial losses, outweighs the positive aspects, leading to a negative sentiment.
The earnings call summary presents a mixed picture. Financial performance is weak due to a widening net loss, but the company has a strong balance sheet. Product development is positive with ongoing trials and new acquisitions, yet market strategy faces hurdles like reimbursement issues. The Q&A highlights management's optimism but lacks concrete metrics, which may concern investors. The absence of short-term guidance adds uncertainty. Despite potential in new drugs, the immediate outlook is uncertain, balancing positive long-term prospects with short-term challenges, resulting in a neutral sentiment.
The earnings call reveals several concerns: missed EPS expectations, significant net loss, increased expenses, and no shareholder return plan. Despite optimistic guidance and strategic initiatives, these financial challenges and potential regulatory risks overshadow the positives. The Q&A session did not alleviate concerns, with some unclear responses. Given these factors, the stock is likely to experience a negative reaction in the short term.
The earnings call presents mixed signals, with strong growth potential for UGN-102 and Jelmyto, but significant risks including regulatory challenges, financial losses, and competitive pressures. The Q&A highlights concerns about the single-arm study for UGN-102, and management's vague responses increase uncertainty. Despite a solid cash position, the financial strain and potential reimbursement issues weigh heavily. The market's reaction is likely to be negative, particularly due to the ODAC meeting's potential impact and the lack of clear guidance on critical issues.
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