What Cerus Corporation told the SEC could break it.

Cerus does not own manufacturing facilities and makes its INTERCEPT Blood System through a number of third-party suppliers, many of whom are its sole qualified suppliers for the particular product or component they manufacture — for example, Porex is its sole supplier of compound adsorption devices and the platelet additive solutions used with INTERCEPT are exclusively made by Fresenius (InterSol) and MacoPharma (SSP+); any supply or manufacturing problem, a supplier's loss of FDA cGMP/QSR compliance, or upstream raw-material disruption could delay or halt supply, and qualifying alternates is time-consuming and costly with no assurance of success.

“We do not own our own manufacturing facilities, but rather manufacture our products using a number of third-party suppliers, many of whom are our sole suppliers for the particular product or component that we procure.”

Cerus has meaningful customer/receivable concentration: three customers each accounted for more than 10% of outstanding accounts receivable at December 31, 2025 (cumulatively ~50%, versus a single customer and 37% a year earlier), so non-payment or loss of a major blood-center/blood-bank customer would materially affect collections; its INTERCEPT customers also depend on access to compatible platelet additive solutions (InterSol/SSP+) and devices, adding interdependency risk to demand.

“The Company had three and one customer(s) that accounted for more than 10% of the Company's outstanding accounts receivable at December 31, 2025 and December 31, 2024 , respectively. These customers cumulatively represented approximately 50 % and 37 % of the Company's outstanding accounts receivable”

Cerus relies on a Term Loan Credit Agreement and a Revolving Loan Credit Agreement (whose terms require prior written consent for any dividends) and on government contract funding from BARDA and the U.S. Department of Defense to support development of the INTERCEPT Blood System; the amount and availability of that government funding is subject to executive orders impacting contract funding/personnel and appropriations uncertainty, so its debt obligations combined with uncertain non-dilutive funding and ongoing operating cash needs create liquidity and refinancing risk.

“any cash dividends declared or paid would require prior written consent under the terms of our Term Loan Credit Agreement and Revolving Loan Credit Agreement.”

Cerus owns 51% of (and consolidates) the Cerus Zhongbaokang joint venture with Shandong Zhongbaokang to develop, gain approval for, manufacture and commercialize INTERCEPT for platelets and red blood cells in China; the JV must first obtain Chinese regulatory approval, which may require additional clinical studies and data from Chinese sites/donors with no assurance of success, and Cerus warns it may be unable to realize a return on or monetize its JV investment — so anticipated China revenues could be delayed or never materialize.

“The JV will need to obtain regulatory approval for the INTERCEPT Blood System for platelets and red blood cells before it can begin commercializing in China. In order to obtain that regulatory approval, the JV may need to run additional clinical studies in China and will have to generate data from Chinese sites and donors using the products.”