Cerus Q4 Earnings Call Highlights

Cerus (NASDAQ:CERS) executives highlighted record fourth-quarter and full-year 2025 product revenue, accelerating international momentum, and continued progress toward profitability during the company’s fourth-quarter and full-year 2025 earnings call.

2025 performance and INTERCEPT adoption

Chief Executive Officer William “Obi” Greenman said Cerus continues to focus on its mission of establishing the INTERCEPT Blood System as a global standard of care for transfused blood components. Based on kits sold, Greenman said blood center customers produced approximately 3 million INTERCEPT-treated blood components in 2025 for patients in nearly 40 countries. Cerus estimates roughly 600,000 patients received INTERCEPT-treated components over the course of the year.

Greenman also pointed to 2025 as a milestone year operationally, including European CE mark approval and a commercial launch of the INT200 device, the company’s next-generation LED-based illuminator. Management said customer feedback on INT200’s operational improvements has been “very positive.” In the U.S., Cerus said it remains on track to submit a premarket approval (PMA) application for INT200 in mid-2026.

Commercial update: U.S. platelets, BCA agreement, and international growth

Chief Operating Officer Vivek Jayaraman said Cerus finished 2025 with “another quarter of strong performance” across its global platelet franchise, “continued positive traction” with the international rollout of INT200, and “increasing momentum” in its U.S. IFC business, resulting in record quarterly and annual product revenue.

In the U.S., Jayaraman said INTERCEPT-treated platelets are the standard of care and estimated Cerus’ platelet market share in the “mid-60s.” He added that the company believes it is positioned for further penetration, citing the recently signed group purchasing agreement with Blood Centers of America (BCA). The agreement was finalized in December and went into effect Jan. 1, management said. Jayaraman described BCA as the largest blood supply cooperative in the U.S., with member centers accounting for roughly 50% of the nation’s blood supply.

While many BCA members already use INTERCEPT, Cerus estimated overall penetration within BCA at approximately 30%. Jayaraman said Cerus expects the agreement to facilitate discussions across the network, enable streamlined contracting, and leverage BCA’s supply chain—steps the company believes could increase adoption across BCA members.

During the question-and-answer session, Jayaraman added that BCA’s contracting platforms, education channels, and supply chain network could allow Cerus to more efficiently expand sales and marketing reach. He said Cerus has already seen inbound inquiries in early 2026 from BCA members that have not previously used INTERCEPT, as well as increased “depth” from existing users who still have room to expand adoption. He also noted a joint webinar series with BCA, including an initial session that drew more than 150 attendees.

Internationally, Jayaraman said the EMEA franchise delivered “robust growth” in both the fourth quarter and full year, with strong double-digit growth in platelet and plasma kit sales. He said the INT200 rollout in the region continues to go well and is supported by positive customer feedback.

Germany initiative and EMEA outlook

Cerus highlighted Germany as a notable opportunity within EMEA. Jayaraman referenced the INITIATE study, a post-market phase 4 observational study that began enrollment at DRK Baden-Württemberg–Hessen, described as the largest blood center in Germany. Management said the study is designed to evaluate routine use of pathogen-inactivated platelets with INTERCEPT and to help build evidence supporting reimbursement and broader adoption.

Cerus estimated Germany represents a $30 million annual platelet opportunity. Jayaraman said the INITIATE study is expected to continue enrolling over 2026, and the company believes Germany could contribute more meaningfully to revenues “as early as 2027.” He also cited favorable momentum in the Middle East and ongoing opportunities in Southern Europe, while characterizing France as a stable and important market.

Asked specifically about the Middle East, Jayaraman pointed to Saudi Arabia as a significant volume opportunity, noting the region often looks to AABB and U.S. FDA standards in establishing protocols and that U.S. standard-of-care status for INTERCEPT platelets can be influential. He said there is “a lot of room” for further penetration in countries such as Kuwait, Qatar, and Saudi Arabia.

IFC momentum and shift to kit-based model

Management also detailed growth in IFC. Jayaraman said customer demand, measured by therapeutic dose equivalents, increased by over 50% in the fourth quarter compared with the same period last year, while IFC revenue grew by nearly 40% year over year in the quarter.

He said nearly 70% of IFC sales in the fourth quarter were kits sold to blood centers, up from about 50% in the prior-year period. Cerus expects nearly all IFC sales volume to be in kit format by the end of 2026. Jayaraman added that Cerus believes the BCA agreement can further support IFC demand by integrating existing IFC production partners and leveraging member centers that can expand manufacturing.

Financial results, profitability progress, and 2026 guidance

Chief Financial Officer Kevin Green said total 2025 revenue was $233.8 million, up 16% from 2024 and a record for the company. He said product revenue increased 14% for both the quarter and full year and exceeded the high end of prior product revenue guidance of $202 million to $204 million. Green attributed significant growth to EMEA, driven by platelet and plasma demand and the early INT200 rollout. He noted Cerus has an installed base of approximately 400 INT-100 illuminators in EMEA that the company expects to replace over the next few years.

Green said that excluding foreign exchange effects, EMEA product revenue increased 25% in the fourth quarter and 14% for the full year. On a consolidated basis, foreign exchange provided an approximate 3% benefit in the fourth quarter and about a 1.6% benefit for the full year compared with the prior year.

On IFC, Green reported fourth-quarter IFC product revenue of $4.2 million versus $3.0 million in the fourth quarter of 2024, and full-year IFC product sales of $16.7 million versus $9.2 million in 2024. He said underlying volume demand increased roughly 110% year over year, with the difference between revenue growth and demand growth tied to the continued shift from selling finished therapeutics directly to hospitals toward selling kits to blood centers.

For 2026, Cerus reaffirmed product revenue guidance of $224 million to $228 million, representing 9% to 11% growth compared to 2025. Green said the outlook does not account for potential changes in the tariff landscape. The guidance includes expected 2026 IFC revenue of $20 million to $22 million, implying 20% to 30% year-over-year growth. Green added that given the kit mix shift, IFC guidance “may underestimate” current enthusiasm. Cerus estimated it exited 2025 with IFC market adoption around 7% and said penetration could increase by more than 50% by the end of 2026.

On margins, Green reported fourth-quarter product gross margin of 51.5%, down from 53.9% a year earlier, citing higher IFC therapeutic production costs, import tariffs, and inflationary pressures. Assuming the status quo on tariffs, he said Cerus expects 2026 product gross margin to trend around the low-50% range, with potential quarterly variability. He also said Cerus cannot predict the ultimate tariff impact due to a dynamic environment.

Operating expenses increased 7% in the fourth quarter and 10% for the full year, which Green said reflected continued leverage in the profit-and-loss model. R&D expense changes were driven primarily by increased red blood cell (RBC) program development costs—mainly reimbursed by BARDA—and costs related to planned PMA submissions for INT200. Green noted Cerus’ 2016 BARDA contract will expire in September and said government-reimbursed R&D expense and corresponding revenue are expected to taper over the course of 2026 as work tied to the phase 3 RedeS study is largely behind the company.

Green said GAAP net loss attributable to Cerus was $2.2 million in the fourth quarter and $15.6 million for the full year, down 25% from the prior year. On a non-GAAP basis, adjusted EBITDA was $3.4 million in the fourth quarter, marking the seventh consecutive quarter of positive adjusted EBITDA, and $9.5 million for the full year, the second consecutive year of positive adjusted EBITDA. Looking to 2026, he said Cerus expects a third consecutive year of positive adjusted EBITDA driven by product revenue growth, gross profit dollar growth, and operating leverage.

Cerus ended 2025 with nearly $83 million in cash and short-term investments. Green said operating cash flow was $6.2 million in the fourth quarter and $4.8 million for the full year. Asked about 2026 cash flow, he said the company expects to continue generating operating cash flows while maintaining inventory to support anticipated growth.

On RBC program progress, Greenman said U.S. enrollment is complete in the phase 3 RedeS study and the company expects to report top-line results later in 2026. In Europe, management said its RBC regulatory submission has completed review of submission modules at the notified body (TÜV SÜD) and is being transferred to ANSM for consultation and review of the active pharmaceutical ingredient. In Q&A, Cerus said it expects a roughly 210-day review clock at ANSM once accepted, and indicated this could support a possible approval in the first half of 2027, assuming no issues arise in review.

About Cerus (NASDAQ:CERS)

Cerus Corporation is a biomedical products company dedicated to enhancing the safety of blood transfusions worldwide. Its flagship offering, the INTERCEPT Blood System, employs pathogen reduction technology designed to inactivate a broad spectrum of viruses, bacteria, and parasites in donated platelets and plasma. This approach aims to mitigate the risk of transfusion-transmitted infections and improve blood component safety for patients.

The INTERCEPT platform integrates seamlessly into existing blood center workflows, providing a one-step treatment process for collected blood products.