Nuvation Bio (NUVB) TD Cowen 46th Annual Health Care Conference summary

Market and product performance

• Patient starts have been robust, with Q4 new patient starts increasing to 216 from 204 in Q3, six times higher than a comparable launch benchmark.

• Majority of early patients were TKI-experienced, but first-line patient share is increasing monthly, expected to drive future growth.

• Discontinuation rates are low in first and second line settings, with most discontinuations occurring in late-line patients, aligning with clinical trial data.

• Revenue ramp is expected to be non-linear, with higher revenues anticipated in the second half of the year and consensus for annual revenue at $147 million.

• The product is already considered the standard of care among ROS1 TKIs, with superior efficacy and tolerability compared to competitors.

Access, reimbursement, and market dynamics

• Gross-to-net adjustments were about 25% in Q4 and are expected to increase slightly, driven by 340B, Medicaid, and some contracting.

• Access remains strong, with limited free drug programs and high confidence in continued reimbursement.

• Community adoption is rising, shifting from initial academic center dominance, with ongoing efforts to increase genetic testing rates.

• The majority of patients are expected to be in the community setting, and policy changes like mandated NGS testing are supporting broader adoption.

International expansion and partnerships

• A deal with Eisai will lead to a European filing in the first half of the year, with approval expected early next year.

• EUR 50 million milestone already received, with an additional EUR 25 million due upon approval, and high double-digit royalties anticipated.

• A head-to-head study against Crizotinib is ongoing in China for regulatory purposes, not required for Europe.

• European pricing is expected to be lower than the U.S., but the market opportunity remains significant.