Short answer
IOVANCE BIOTHERAPEUTICS, INC. (IOVA) filed its fiscal 2025 10-K annual report with the SEC on Feb 24, 2026. It reported revenue of $264M (+60.6% year over year) and net income of −$391M.
- Top risk flagged: Cybersecurity risk from internal systems and CROs, requiring increased resources to counter sophisticated threats
FY2025 key financial metrics · XBRL
- Revenue
- $264M
- +60.6% YoY
- Net income
- −$391M
- −5.1% YoY
- Operating margin
- -153.1%
- +87.8 pp YoY
- EPS (diluted)
- −$1.09
- +14.8% YoY
- ROE
- -56.0%
- −3.6 pp YoY
- Operating cash flow
- −$302M
- +14.3% YoY
Source: XBRL data from the IOVANCE BIOTHERAPEUTICS, INC. (IOVA) FY2025 10-K on SEC EDGAR. USD.
IOVANCE BIOTHERAPEUTICS, INC. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Commercial-stage biopharma pioneering individualized tumor infiltrating lymphocyte (TIL) cell therapies for solid tumor cancers
- New/regulatory: Amtagvi approved in U.S. and Canada, pending UK/Australia 2026 approvals, withdrawn and resubmitting EU MAA in 2026
- Strategic shift: Transitioned all Amtagvi/lifileucel manufacturing in-house at FDA-approved iCTC facility, ending contract manufacturing early 2026
- Quantitative highlight: Over 1,500 patients treated with commercial/investigational TIL therapies; iCTC capacity >5,000 patients annually
- Noteworthy fact: Presented first real-world Amtagvi data (44% ORR) in 2026; advancing Phase 3 TILVANCE-301 trial combining lifileucel with pembrolizumab in frontline melanoma
Management Discussion & Analysis
- Revenue $263.5M, up 61% YoY; Amtagvi $220.0M (up $116.5M), Proleukin $43.5M (down $17.0M)
- Cost of sales $173.2M, up 86%; R&D $300.3M, up 9%; SG&A flat at $152.3M; total expenses $666.9M, up 19%
- Best performing segment: Amtagvi revenue $220.0M, worst: Proleukin revenue down 28% to $43.5M
- No explicit cash flow, buybacks, dividends data provided; capex details not disclosed
- Outlook: expect European MAA resubmission in 2026; ongoing clinical trials in multiple indications; focus on global commercial expansion and manufacturing optimization
Risk Factors
- Cybersecurity risk from internal systems and CROs, requiring increased resources to counter sophisticated threats
- Dependency on IT infrastructure vulnerable to security breaches impacting business operations
- Audit Committee oversight on internal controls risks related to cybersecurity threats
- Management led by VP, Infrastructure and Security with professional cybersecurity certifications tasked with risk management
- External cybersecurity consultants employed alongside internal team for enhanced protection measures
Generated from the filing text; verify against the original. How to read a 10-K
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