Nuvation Bio (NUVB) investor relations material

IBTROZI launch and commercial performance

• IBTROZI launch saw 432 patients in two quarters, six times the initial uptake of a key competitor, with strong adoption across all sales territories and growing first-line use.

• Majority of prescriptions remain in later lines, but first-line use is increasing monthly; 75% of discontinuations are from third-line plus, reflecting shorter therapy duration in later lines.

• Discontinuation rates and side effects align with clinical trial data, with no unexpected safety signals.

• Consensus sales estimate for the first full year is just under $150 million, with revenue growth expected to accelerate in the second half as first-line patients accumulate.

• Gross to net has been slightly above 25% and is expected to stabilize after a modest increase; free drug programs have been limited due to strong reimbursement.

Market dynamics and competitive landscape

• Rapid patient uptake attributed to both market expansion and fast penetration; improved ROS1 testing, especially RNA-based, is expected to grow the market by about 30%.

• NCCN guideline changes now contraindicate IO and recommend ROS1 TKIs, supporting increased use and earlier adoption of IBTROZI.

• Sales force is focused on shifting adoption from academic centers to community practices, which represent the majority of patients; current structure is considered efficient.

• IBTROZI offers a superior efficacy and durability profile compared to other ROS1 TKIs, with an 89% response rate and PFS up to 50 months, and the highest intracranial response rates.

• Generic crizotinib is not considered competitive due to lack of brain penetration; IBTROZI is positioned as the preferred choice for long-term survival.

Pipeline and future plans

• Nuvalent is expected to launch a competitor in second-line plus later this year, but IBTROZI shows higher response and intracranial rates, and will have treated most eligible patients by then.

• IBTROZI is the only ROS1 TKI in adjuvant trials, aiming to secure first-mover advantage in this large population.

• Safusidenib, a mutant IDH1 inhibitor, shows superior response and progression-free survival compared to the only approved competitor in low risk, low grade glioma.

• Ongoing SIGMA study targets three additional glioma subtypes, potentially expanding the addressable market; a separate trial in grade 3 oligodendroglioma could enable approval based on response rate.

• Initial data from the oligodendroglioma trial expected this year, with potential for regulatory discussions if response rates are robust.