Nuvation Bio (NUVB) investor relations material

Commercial performance and product adoption

• ZUSDURI revenue reached $30 million in 1Q, marking over 100% quarter-over-quarter growth, with strong early adoption and repeat prescribing indicating positive physician and patient experiences.

• Permanent J-code significantly improved reimbursement and accelerated adoption, especially in community practices, shifting the hospital/community mix closer to 50/50.

• Community practices are increasingly adopting ZUSDURI due to reimbursement clarity and fit with existing treatment workflows, with expectations that 65% of revenue will ultimately come from this segment.

• 95% open access for reimbursement has been achieved, with no denials reported and increasing patient-driven demand.

Clinical data and market positioning

• VISION trial 36-month follow-up showed 64.5% of patients maintained response, with median duration not yet reached, suggesting durable benefit.

• ZUSDURI is being adopted first in difficult-to-treat patients, with physicians reporting complete responses even in challenging cases.

• As adoption grows, the drug is expected to move earlier in the treatment continuum, expanding its impact.

• Pricing is considered appropriate for the low-grade market, with favorable cost-benefit positioning.

Pipeline and future growth opportunities

• UGN-103 (next-gen mitomycin) in the UTOPIA phase III trial shows data consistent with ZUSDURI, with plans to expand into high-grade and adjuvant settings.

• UGN-104 for upper tract disease is progressing, with full enrollment expected this year.

• The oncolytic virus program (501) is entering first-in-human studies, with potential to expand beyond bladder and urothelial cancers.

• The company aims to leverage its pipeline to become a leader in urothelial and specialty cancers, with 501 seen as a key catalyst for diversification.