Short answer
Nuvation Bio Inc. (NUVB) filed its fiscal 2025 10-K annual report with the SEC on Mar 2, 2026. It reported revenue of $63M (+699.0% year over year) and net income of −$205M.
- Top risk flagged: Regulatory risk: FDA approval and post-approval obligations for IBTROZI (taletrectinib) granted June 11, 2025 for ROS1+ NSCLC treatment
FY2025 key financial metrics · XBRL
- Revenue
- $63M
- +699.0% YoY
- Net income
- −$205M
- +64.0% YoY
- Operating margin
- -338.7%
- +7188.6 pp YoY
- EPS (diluted)
- −$0.60
- +71.6% YoY
- ROE
- -66.9%
- +55.5 pp YoY
- Operating cash flow
- −$173M
- −33.0% YoY
Source: XBRL data from the Nuvation Bio Inc. (NUVB) FY2025 10-K on SEC EDGAR. USD.
Nuvation Bio Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Global oncology focused on developing novel small molecule therapies for difficult-to-treat cancers, leveraging medicinal chemistry and clinical data
- New emphasis: U.S. commercial launch of IBTROZI (taletrectinib) for ROS1+ NSCLC approved June 2025, plus new Eisai partnership for European and other territories in 2026
- Strategic shift: Expansion into global commercialization via partnerships in China, Japan, Europe, and additional territories, extending reach beyond prior regional focus
- Quantitative highlight: 71 U.S. commercial field team members for IBTROZI launch, with nearly 300 patients enrolled in pivotal Phase 2 global clinical trial program
- Noteworthy: Median duration of response for IBTROZI matured to 50 months by August 2025, supporting its potential as new standard of care in ROS1+ NSCLC
Management Discussion & Analysis
- Revenue and profitability data not disclosed in MD&A section
- No cash flow, buybacks, dividends, or capex information given
- Forward-looking statements caution on risks causing actual results to differ materially
Risk Factors
- Regulatory risk: FDA approval and post-approval obligations for IBTROZI (taletrectinib) granted June 11, 2025 for ROS1+ NSCLC treatment
- Geopolitical risk: Commercial partnerships in Japan (NK) and China (Innovent) expose revenue to MHLW and NMPA regulatory environments
- Operational risk: High R&D expenses increased by $16M in 2025 driven by clinical trial costs and headcount growth, with continued need for funding
- Competitive risk: Phase 3 TRUST-III study compares taletrectinib to crizotinib in China, a key competitor in ROS1+ NSCLC market
- Financial risk: $250M non-dilutive financing includes $150M synthetic royalty financing with tiered royalties up to 2.0x investment, plus $100M senior secured loan at SOFR+6% interest
Generated from the filing text; verify against the original. How to read a 10-K
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