Cerus Corporation Q4 FY2025 earnings call

Business Highlights - Blood Supply and Mission: Cirrus is dedicated to safeguarding the blood supply, with the mission to establish Intercept as a global standard of care. In 2025, blood center customers produced ~3 million Intercept - treated blood components for nearly 40 countries, benefiting ~600,000 patients. - INT200: Received European CE mark approval, commercially launched, with positive customer feedback. In the US, on track to submit PMA application for INT - 200 in mid - 2026. - Red Blood Cells: In Europe, regulatory submission to TUV completed, dossier transferred to ANSM. In the US, enrollment complete in REDIS study, expect top - line results later in 2025. - Commercial Results: 2025 was a milestone year. US platelet franchise is foundation, with mid - 60s market share, and Group Purchasing Agreement with BCA expected to drive broader adoption. EMEA franchise had robust growth in Q4 and full year, with strong double - digit growth in platelet and plasma kit sales, and positive feedback on INT200 rollout. ISC customer demand increased, with nearly 70% of Q4 sales in kit form, expecting nearly all sales to be in kit format by end of 2026.

In 2025, total revenues were $233.8 million, a record level. Product revenue was record, up 14% for the quarter and year. EMEA led growth with double - digit growth in platelet and plasma kit sales, and early rollout of INT200. North America's full - year product revenue growth was driven by increased IFC sales and strong platelet business. IFC product revenue in Q4 2025 was $4.2 million, up 40% from Q4 2024; full - year IFC product sales were $16.7 million, up 80% from 2024. Product gross margin in Q4 2025 was 51.5% compared to 53.9% in Q4 2024, impacted by higher IFC therapeutic production costs, import tariffs, and inflation. Non - GAAP adjusted EBITDA for Q4 2025 was $3.4 million, seventh consecutive quarter of positive; full - year non - GAAP adjusted EBITDA was $9.5 million, second consecutive year of positive.

2026 product revenue guidance is $224 to $228 million, a year - over - year increase of 9 to 11% compared to 2025 (excluding tariff impact). Expected IFC revenue in 2026 is $20 to $22 million, year - over - year growth of approximately 20 to 30%. Expect 2026 product gross margin to continue to trend around the low 50% range. Expect third consecutive year of positive non - GAAP adjusted EBITDA driven by product revenue growth, gross profit dollar growth, and operating expense leverage.

Forward - looking statements involve risks and uncertainties. Risks include those related to future financial and operating results, clinical trial data availability, regulatory submissions, commercial expansion, market opportunities, import tariffs, inflationary pressures, and potential differences between actual and expected events, performance, and results. These are identified in the press release, slide presentation, and Form 10 - K.

Q: Talk more about the BCA agreement. What is different for Cirrus because of this contract and what drives penetration beyond current levels, and any early anecdotes.

A: Vic responded that BCA represents roughly half the market in blood product distribution. In the US platelet market, penetration is ~30% in BCA members. The contract allows leveraging BCA's supply chain, contracting platforms, and education channels. Inbound inquiries from BCA member institutions not previously using Intercept and increased depth with existing users are encouraging. On IFC, legacy manufacturing partners move under BCA umbrella, facilitating product movement and leveraging sales channels. Had a webinar with BCA with over 150 attendees.

Q: Ask about EMEA, growth in Germany, and update on red blood cells in Europe and US.

A: Mark asked about EMEA growth, Germany study. Vivek said INITIATE study in Germany is phase four post - market, enrolling in 2026, likely to contribute more meaningfully in 2027 and beyond. For red blood cells in Europe, TUV completed review, dossier transferred to ANSM, with possible approval in first half of 2027. In the US, enrollment complete in REDIS study, expect Q4 2026 readout.

Q: Ask about strength in Middle East and penetration rate.

A: Vivek said the biggest opportunity in the Middle East is Kingdom of Saudi Arabia, with influence from US standards, and room for growth in Kuwait, Qatar, etc.