Record Annual Revenue
Total revenues for 2025 were $233.8 million (record), up 16% year-over-year versus 2024.
Product Revenue Beat and Growth
Record product revenue rose 14% for both the quarter and full year, exceeding prior guidance of $202M–$204M.
Strong EMEA Performance
EMEA product revenue (ex-FX) increased 25% in Q4 and 14% for the full year; growth driven by platelet and plasma kit sales and early INT200 rollout.
IFC Demand and Revenue Acceleration
IFC Q4 product revenue was $4.2M vs. $3.0M in Q4 2024 (~40% increase). Full-year IFC product sales were $16.7M vs. $9.2M in 2024 (~80% growth). Underlying IFC volume increased ~110% year-over-year.
Shift to Kit-Based IFC Model
In Q4, ~70% of IFC sales were kits (up from ~50% prior year); company expects nearly all IFC sales to be kit-based by year-end, supporting scalable production by blood centers.
INT200 Regulatory and Commercial Progress
Received CE Mark and commercially launched INT200 in Europe with positive customer feedback; on track to submit U.S. PMA for INT200 in mid-2026.
Red Blood Cell Program Milestones
TÜV review of RBC dossier completed and file being transferred to ANSM for consultation; U.S. RedeS Phase III enrollment complete with topline results expected late 2026.
Strategic BCA Agreement
Group purchasing agreement with Blood Centers of America effective Jan 1; BCA members account for ~50% of U.S. blood supply and estimate ~30% current INTERCEPT penetration within BCA, enabling broader adoption and streamlined contracting.
Profitability and Cash Position
Q4 adjusted EBITDA of $3.4M (seventh consecutive positive quarter); full-year adjusted EBITDA $9.5M (second consecutive positive year). GAAP net loss narrowed to $15.6M for full year (down 25% YoY). Cash and short-term investments totaled ~$83M at year-end.
2026 Revenue Guidance and IFC Outlook
Reaffirming 2026 product revenue guidance of $224M–$228M (+9% to +11% YoY). Included IFC revenue guidance $20M–$22M (+~20% to +30% YoY). Management expects continued positive adjusted EBITDA in 2026.
Commercial Momentum in Key Markets
Notable international traction including Germany (INITIATE Phase IV study started) — Germany platelet opportunity estimated at ~$30M annual; growth also noted in Middle East markets such as Saudi Arabia, Kuwait and Qatar.