Nuvation Bio (NUVB) Q4 2025 earnings summary

Executive summary

• Achieved full FDA approval and rapid U.S. launch of IBTROZI for advanced ROS1-positive NSCLC, with 432 new patients treated in 2025, including 216 in Q4.

• IBTROZI is being adopted at a rate six times faster than prior ROS1 TKI launches, with strong uptake in both academic and community settings.

• Initiated global expansion with approvals in China and Japan, and a strategic partnership with Eisai for Europe and other ex-U.S. territories.

• Advanced safusidenib for IDH1 mutant glioma, with phase III SIGMA trial underway and positive Phase 2 results showing durable responses and high progression-free rates.

• Maintained a strong cash position of $529.2 million as of December 31, 2025.

Financial highlights

• Q4 2025 total revenue was $41.9 million, with full-year revenue at $62.9 million, including $24.7 million in IBTROZI U.S. net product revenue.

• Received a $25 million milestone payment from Japan approval and $60 million upfront from Eisai partnership.

• Collaboration and license agreements revenue was $26.2 million in Q4 2025, mainly due to the Nippon Kayaku milestone.

• R&D expenses were $34.3 million for Q4 and $115.1 million for the year; SG&A expenses were $40.3 million for Q4 and $151.6 million for the year.

• Net loss for Q4 2025 was $36.6 million ($0.11 per share), and $204.6 million ($0.60 per share) for the year, both improved from 2024.

Outlook and guidance

• Expect continued growth in first-line IBTROZI use, which will drive long-term revenue as more patients remain on therapy for extended periods.

• Plan to file for European approval of IBTROZI in the first half of 2026 and expand global reach through the Eisai partnership.

• SIGMA phase III trial for safusidenib expected to read out in 2029; non-pivotal grade 3 oligodendroglioma cohort readout anticipated in 2027.

• Ongoing evaluation of additional preclinical candidates and external business development opportunities.

• No additional external financing anticipated to reach profitability based on current cash and revenue trajectory.