Short answer
ImmunityBio, Inc. (IBRX) filed its fiscal 2025 10-K annual report with the SEC on Feb 23, 2026. It reported revenue of $113M (+668.3% year over year) and net income of −$351M.
- Top risk flagged: Regulatory risk from potential NCCN guideline decision on BCG-unresponsive NMIBC papillary-only disease expansion expected Q1/Q2 2026
FY2025 key financial metrics · XBRL
- Revenue
- $113M
- +668.3% YoY
- Net income
- −$351M
- +15.0% YoY
- Operating margin
- -226.0%
- +2108.2 pp YoY
- EPS (diluted)
- −$0.38
- +38.7% YoY
- ROE
- 70.2%
- −14.3 pp YoY
- Operating cash flow
- −$305M
- +22.1% YoY
Source: XBRL data from the ImmunityBio, Inc. (IBRX) FY2025 10-K on SEC EDGAR. USD.
ImmunityBio, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Development and commercialization of biologic drugs, with focus on regulatory approvals and post-marketing requirements
- New emphasis on commercialization efforts for approved product ANKTIVA and building sales, marketing, and distribution capabilities
- Strategic shift toward handling complex FDA accelerated approval pathways and orphan drug exclusivity following 2026 Orphan Drug Act codification
- Post-marketing commitments for ANKTIVA include QUILT-3.032 trial completion by end of 2029 and annual FDA reporting up to 4 years
- Increased focus on cybersecurity risks and use of AI in business, highlighting vulnerabilities and operational disruption potentials
Management Discussion & Analysis
- Revenue started from ANKTIVA sales since May 2024; no dollar amounts or YoY change disclosed
- Operating expenses expected to increase substantially due to commercialization and R&D expansion; no margin % figures provided
- No segment-specific performance data or best/worst performing segment disclosed
- Cash and equivalents plus sales and potential equity offerings expected to fund operations for next 12 months; no buyback/dividend/capex details provided
- Management highlights significant funding risks, need for additional capital to sustain operations, and regulatory/commercialization uncertainties impacting future outlook
Risk Factors
- Regulatory risk from potential NCCN guideline decision on BCG-unresponsive NMIBC papillary-only disease expansion expected Q1/Q2 2026
- Geopolitical exposure via dependency on 33 countries with ANKTIVA approval including US, UK, EU, Saudi Arabia, and MENA launches
- Supply vulnerability as company supports FDA Expanded Access Program for rBCG to address U.S. supply constraints
- Competitive risk from CPI combination therapies in metastatic NSCLC with conditional SFDA approval and planned commercial launch in 60 days
- Financial risk in rapid revenue growth: ANKTIVA sales $113M FY2025, 700% YoY increase, requiring scaling of 85-person EU sales force and global partnerships
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