ImmunityBio ANKTIVA Drives 700% YoY Revenue Surge to $113M with 33-Country Approvals
ImmunityBio’s Q4 net product revenue rose to $38.3M, boosting full-year 2025 sales to $113M versus $14.1M in 2024, as ANKTIVA unit volumes jumped 750%. The company gained ANKTIVA authorization in 33 countries—including EU conditional approval and Saudi FDA clearances—and plans a Q4 2026 BLA submission with 85% response rates.
1. Q4 and Full-Year Revenue Growth
Q4 net product revenue was $38.3M, up 20% sequentially. Full-year 2025 net product revenue reached $113M compared to $14.1M in 2024, reflecting a 700% increase driven by a 750% rise in ANKTIVA unit sales and repeat prescribing behavior among physicians.
2. International Approvals and Commercial Expansion
ANKTIVA secured authorizations in 33 countries, including conditional marketing approval from the European Commission in February 2026 and two Saudi FDA clearances for bladder cancer CIS and checkpoint inhibitor combination in metastatic NSCLC. The company partnered with Accord Healthcare to deploy over 100 commercial professionals across Europe and established subsidiaries in Ireland and Saudi Arabia.
3. Clinical Data and Regulatory Milestones
Interim QUILT trial data showed 85% complete response rates at six months for BCG-naïve patients treated with ANKTIVA versus 57% for BCG alone. ImmunityBio targets a BLA submission for the BCG-naïve indication in Q4 2026 and is advancing other bladder and lung cancer signals.
4. Financial Health and Expenses
In 2025, R&D expenses rose to $218.6M from $190.2M, while SG&A decreased to $150M. The net loss narrowed to $351.4M versus $413.6M in 2024, with $242.8M in cash and marketable securities and $505M in convertible notes outstanding.