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

Market and launch performance

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

• Majority of early patients were TKI-experienced, but first-line patient numbers are rising monthly, expected to drive future growth.

• Discontinuation rates are low in first and second line settings, with most discontinuations occurring in late-line patients, reflecting expected clinical behavior.

• Revenue ramp is expected to accelerate in the second half of the year, with consensus revenue guidance at $147 million for the year.

• If current patient acquisition rates continue, annualized revenue could reach $220 million, with upside from further growth.

Drug efficacy, tolerability, and competitive landscape

• First-line response rate for Taletrectinib exceeds 90%, with a median duration of response of 50 months, considered exceptional in oncology.

• Adverse event-related discontinuations are extremely low, with only 1 out of 337 patients discontinuing for the top 6 adverse events.

• The drug is becoming the standard of care among ROS1 TKIs, with competitors like ROZLYTREK and Repotrectinib facing challenges in efficacy and tolerability.

• Community adoption is increasing, shifting from initial academic center dominance, aided by rising genetic testing rates.

Access, reimbursement, and financials

• Gross-to-net adjustments are expected to grow slightly above 25%, influenced by 340B, Medicaid, and some contracting, but access remains strong.

• Eisai partnership in Europe includes €50 million already received, €25 million milestone on approval, and high double-digit royalties.

• European approval is targeted for early next year, with pricing expected to be lower than in the U.S.

• After the next milestone, cash reserves will be about $620 million, providing ample runway for operations and potential business development.