Nuvation Bio Inc. Q4 FY2025 earnings call

Key Achievements - On June 11, 2025, IBTROZI received full U.S. FDA approval for advanced ROS1-positive non-small cell lung cancer. - By end of 2025, 432 new patients started IBTROZI, with 216 in Q4. - IQVIA data shows IBTROZI prescription rate 6x faster than prior ROS1 TKI launches. - Phase II study of safusidenib for low-grade IDH1-mutant glioma showed positive results. - Announced strategic partnership with Eisai in January 2026 for IBTROZI development in Europe and other ex-U.S. territories. ### Commercial Launch - IBTROZI has been prescribed to 47 sales territories by multiple repeat prescribers. - Payer engagement constructive with broad coverage to label for patients. - Patient support program Innovation Connect helps eligible patients access IBTROZI. - New patient starts include TKI-naive, TKI-pretreated, and newly diagnosed patients. - Academic centers and community centers have seen use, with gradual shift towards community centers. ### Financial, Partnering and Operating Updates - Fourth quarter 2025 total revenue $41.9 million, full year 2025 total revenue $62.9 million. - Received $25 million milestone payment from Nippon Kayaku in November 2025. - Upfront payment of ~$60 million from Eisai and eligible for ~$30 million upon European approval. - R&D expenses $34.3 million in Q4 2025, $115.1 million for full year 2025. - SG&A expenses $40.3 million in Q4 2025, $151.6 million for full year 2025. - Ended 2025 with $529.2 million in cash, cash equivalents and marketable securities.

In 2025, Nuvation Bio had two main product segments. For IBTROZI: In the fourth quarter, net U.S. product revenue was $15.7 million, and for the full year 2025, it was $24.7 million. A total of 432 new patients started IBTROZI by the end of 2025, with 216 in the fourth quarter. IQVIA data shows patients are being prescribed IBTROZI at a rate approximately 6x faster than the prior 2 ROS1 TKI launches over their first 2 full quarters following approval. For safusidenib: It's an inhibitor of mutant IDH1 being developed for IDH1 mutant glioma. Phase II study of safusidenib for low-grade IDH1-mutant glioma demonstrated a median PFS not reached, 12% progression rate at 24 months and 44% confirmed ORR. Phase I study of safusidenib in a high-grade enhancing population showed 17% confirmed ORR including 2 complete responses lasting multiple years. The DDC platform had NUV-1511 discontinued in the fourth quarter, but learnings are being applied to new preclinical candidates.

IBTROZI - Expect to see more direct correlation between growth in new patient starts and revenue growth by end of 2026 as larger portion of active patients shift to newly diagnosed. - Focus on increasing prescriber base and identifying more newly diagnosed first-line patients. - Plan to present additional long-term IBTROZI data at multiple medical conferences in 2026. ### Safusidenib - Pivotal Phase III study SIGMA is a global randomized study evaluating safusidenib vs placebo for maintenance treatment of high-risk and high-grade IDH1 mutant glioma, expected to read out in 2029. - Second nonpivotal cohort evaluating safusidenib in grade 3 oligodendroglioma, estimate to provide full study readout in 2027. - If significant objective response in grade 3 oligodendroglioma study, will meet with FDA to discuss potential accelerated approval pathway. ### DDC Platform - Hope to have updates on next phase of DDC program by year-end.

Market and Adoption - Seasonality could potentially impact patient starts and revenue, though hard to predict. - Competitor entry in the second-line setting later in the year could impact market share. - Payer negotiations and coverage could affect gross to net and revenue growth. ### Clinical and Development - Uncertainty around enrollment and readout timelines for safusidenib studies. - Challenges in achieving significant objective response rates in certain patient populations for safusidenib that would warrant accelerated approval. - Potential challenges in developing and commercializing new DDC candidates despite learnings from NUV-1511 discontinuation. ### Regulatory - Uncertainty in regulatory approval processes for safusidenib in different patient populations and territories. - Possible need for additional clinical trials or requirements for European approval of IBTROZI that could delay or impact the timeline.

Q: Farzin Haque asks about 2026 revenue guidance and first-line/second-line plus mix confidence.

A: David Hung says they feel patients are out there, trajectory of new patient starts has been good, majority of new patient starts to date have been later lines but seeing increases in first line, confident over time will see growth moving to first-line setting.

Q: Farzin Haque asks about safusidenib Phase III enrollment trajectory and interim analysis.

A: David Hung says haven't commented on enrollment, trial will enroll well but is PFS study so will take time, no plans for interim analysis.

Q: Leonid Timashev asks about IBTROZI trajectory, seasonality, and payer dynamics.

A: David Hung says hard to know if seasonality will result in bounce back, feels confident patients are there, payer engagement is constructive.

Q: Michael Yee asks about IBTROZI patient uptake trajectory, competitive landscape, and TRKb factor.

A: David Hung says expecting over 200 new patient starts per quarter to continue, looking to capture first-line setting, TRKb inhibition contributes to durability, intracranial activity and safety profile.

Q: Michael Yee asks about IBTROZI patient uptake trajectory, competitive landscape, and TRKb factor.

A: David Hung says expecting over 200 new patient starts per quarter to continue, looking to capture first-line setting, TRKb inhibition contributes to durability, intracranial activity and safety profile.

Q: Unknown Analyst asks about IBTROZI first-line adoption, NCCN guideline changes, and safusidenib.

A: David Hung says saw increase in scripts in other TKIs after NCCN guidelines, seeing increasing first line use but glimpse limited, NCCN guidelines and label strength will help.

Q: Unknown Analyst asks about safusidenib Phase III efficacy outcomes, market opportunity, and oligodendroglioma cohort.

A: David Hung says Phase III study targets significant unmet need, second study in grade 3 oligodendroglioma important for unmet need and potential accelerated approval.

Q: Mayank Mamtani asks about IBTROZI new patient start metric, discontinuation in earlier line.

A: David Hung says new patient starts important metric, majority of discontinuations from late-line patients, Philippe Sauvage adds subset through hub shows most discontinuations from late line.

Q: Mayank Mamtani asks about safusidenib nonpivotal cohort SIGMA study ORR threshold for accelerated approval.

A: David Hung says think ORR north of 20% would be interesting.

Q: Gregory Renza asks about resource position and path to profitability, business development.

A: David Hung says confident in reaching profitability with current cash, will carefully weigh business development deals.

Q: Steven Ionov asks about IBTROZI first-line penetration, regulators, BET inhibitor NUV-868, and European approval.

A: David Hung says crizotinib has issues with CNS coverage, engaging regulators for first-line preference, on NUV-868 looking at options, on European approval don't believe additional clinical trials needed.

Q: Silvan Tuerkcan asks about gross to net stabilization.

A: David Hung says gross to net above 25% in Q4, expecting to increase a bit more in coming quarters but hard to predict exact stabilization point.