Management attributes the early 2025 Zasturi revenue of $15.8 million to a deliberate 'foundational' launch phase focused on establishing reimbursement pathways and operational readiness.

The activation of the permanent J code on January 1, 2026, is cited as the primary catalyst for removing adoption barriers, leading to a measurable acceleration in new and repeat prescribers.

Performance in early 2026 indicates that Zasturi's key launch metrics, including patient enrollment forms and new starts, have surpassed the historical trajectory of the company's first product, Jelmyto.

Strategic positioning of Zasturi as the only FDA-approved primary office-based therapy aims to disrupt the standard of care by offering a non-surgical alternative to TURBT procedures.

The company maintains a peak revenue potential estimate of over $1 billion for Zasturi, based on assumptions of high physician adoption and significant penetration into the underserved NMIBC market.

Jelmyto's $94 million in 2025 revenue reflects steady demand in a mature market, with management leveraging the expanded Zasturi sales force to provide incremental support to the franchise.

Management expects to submit an NDA for UGN-103 in 2026, with a strategic plan to rapidly transition the market from Zasturi to this next-generation formulation by 2028.

Guidance for 2026 Jelmyto revenue is set at $97 million to $101 million, assuming a modest growth rate of 3% to 7% as the product reaches maturity.

The company plans to initiate a high-grade NMIBC study for UGN-103 in 2026, pending Type C meetings with the FDA to align on randomized, event-driven trial designs.

Operating expense increases for 2026 are primarily driven by three factors: an increase in noncash share-based compensation expense due to a higher stock price and more employee grants, the annualization of costs from the sales force expansion, and life cycle management plans for UGN-103.

Management anticipates providing formal Zasturi sales guidance only after observing at least two quarters of steady-state demand under the permanent J code.

A $250 million debt refinancing with Pharmakon Advisors reduced the cost of capital from approximately 12% to a fixed 8.25% while extending principal repayment to 2030.

The refinancing provides $75 million in additional non-dilutive capital, which management describes as a 'cushion' to ensure a path to profitability without further equity dilution.

R&D expenses increased to $67.1 million in 2025, driven by pre-approval manufacturing costs for Zasturi, advancing Phase 3 trials for UGN-103 and UGN-104, and the acquisition of UGN-501, though these were partially offset by lower clinical trial and regulatory costs for Sistori.

Management flagged the conversion timeline from patient enrollment to dosing as a current operational lag of 45 to 60 days, with a goal to narrow this to 2 to 3 weeks as practices gain efficiency.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here.

CEO Elizabeth Barrett confirmed that February 2026 indicators for Zasturi, including enrollment forms and doses, have already surpassed Jelmyto's performance at the same stage.

Management noted that while Jelmyto was heavily hospital-concentrated, Zasturi is seeing a 50/50 split between hospital and community settings following the J code activation.

Management intends to launch UGN-103 only after securing a permanent J code for it, likely in 2028, to avoid reimbursement friction.

The company will be 'purposeful' in transitioning users to UGN-103 quickly and plans to withdraw Zasturi shortly thereafter to minimize market confusion.

Chief Medical Officer Mark Schoenberg identified BCG-unresponsive papillary high-grade disease as a key target for UGN-103 as an adjuvant therapy.

Management is evaluating both monotherapy and potential combination regimens to address the broader non-muscle invasive bladder cancer population.

One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.