Cerus Holds 2026 Revenue Forecast at $229 Million to $231 Million and Delays CE Mark to Late 2027
Key Facts
On November 2, Cerus reaffirmed its forecast for product revenue of $229 million to $231 million in fiscal 2026, saying the range includes $23 million to $25 million in IFC revenue. The company translates the forecast into annual growth of 11% to 12% compared with 2025. On the third-quarter earnings call, the CEO said the company now expects to obtain the CE mark for its red blood cell system in late 2027. He linked the new timeline to adding the full clinical report from the REDIS study to its submission in response to questions from France’s ANSM. The decision, he said, “will provide additional clinical evidence, strengthening our application.” Cerus plans a limited launch at a small number of European centers of excellence after approval.
The annual forecast was reaffirmed after Cerus’ third-quarter total revenue rose to $64.0 million from $60.2 million in the same period of 2025. Product revenue increased to $57.7 million, compared with $52.7 million a year earlier. For the nine months ended September 30, product revenue was $168.8 million, versus $148.4 million in the corresponding period of 2025, an annual increase of 14%. Adjusted earnings before interest, taxes, depreciation and amortization were $5.7 million in the third quarter, compared with $5.0 million in the third quarter of 2025. The company said its annual product revenue forecast reflects growth of 11% to 12% from the prior year, with an expected contribution from IFC revenue.
By contrast, third-quarter government contract revenue fell to $6.3 million from $7.5 million in the same period a year earlier. Cerus attributed the decline to the completion of its contract with the U.S. Food and Drug Administration in 2025 and the drawdown of its 2016 Biomedical Advanced Research and Development Authority contract. The company said this was partly offset by the authority’s 2024 contract. These changes reflect the mix of government revenue during the quarter, alongside increases in total revenue and product revenue. Cash, cash equivalents and short-term investments totaled $57.1 million on September 30, 2026. The balance was $82.9 million on December 31, 2025.
On product development, Cerus said the Phase III RedeS study met its primary efficacy endpoint, showing that red blood cells treated with the INTERCEPT system were non-inferior to conventional red blood cells based on adjusted hemoglobin increment. The study found no statistically significant difference in treatment-related adverse events between the study groups. The company also said it observed no evidence of hemolysis or clinical impact from transient low-titer antibodies. Full results, including secondary endpoints, are due to be submitted to a peer-reviewed scientific journal and presented at upcoming scientific meetings. However, the U.S. Food and Drug Administration has not yet reviewed the final clinical report from the RedeS study. Cerus cautioned that the agency’s assessment of the results and the benefit-risk profile may differ from the company’s assessment.
On platelets, the company said the initial questions it received from the U.S. Food and Drug Administration about the INT200 application are addressable, but require additional data collection. It added that approval timelines will become clearer after agreeing with the agency on the scope of the required data. Cerus shares closed the regular session on November 2 at $2.36, up 3.51% from the previous close of $2.28. They fell to $2.20 in after-hours trading, down 6.78% from the regular-session close. The company said a replay of the earnings call would be available on its website about 3 hours after the call. The replay will remain available through November 23, 2026.