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REVENUE AND SEGMENT INFORMATION | 9 Months Ended
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Sep. 30, 2025
REVENUE AND SEGMENT INFORMATION |
REVENUE AND SEGMENT INFORMATION |
| 5. | REVENUE AND SEGMENT INFORMATION
The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2025:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 28 | ​ | $ | — | ​ | $ | 28
Germany | ​ |  | 2,899 | ​ |  | — | ​ |  | 2,899
All other countries | ​ |  | 2,246 | ​ |  | 4,312 | ​ |  | 6,558
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Revenue | ​ | $ | 5,173 | ​ | $ | 4,312 | ​ | $ | 9,485
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2024:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: | ​ |  | ​ | ​ |  | ​ | ​ |  | ​
United States | ​ | $ | 21 | ​ | $ | — | ​ | $ | 21
Germany | ​ |  | 3,181 | ​ |  | — | ​ |  | 3,181
All other countries | ​ |  | 1,937 | ​ |  | 3,474 | ​ |  | 5,411
Revenue | ​ | $ | 5,139 | ​ | $ | 3,474 | ​ | $ | 8,613
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2025: ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 152 | ​ | $ | — | ​ | $ | 152
Germany | ​ |  | 9,050 | ​ | ​ | — | ​ | ​ | 9,050
All other countries | ​ |  | 6,344 | ​ | ​ | 12,283 | ​ | ​ | 18,627
Revenue | ​ | $ | 15,546 | ​ | $ | 12,283 | ​ | $ | 27,829
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2024:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
​ | ​ | (amounts, in thousands)
Revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 63 | ​ | $ | 36 | ​ | $ | 99
Germany | ​ |  | 9,497 | ​ | ​ | — | ​ | ​ | 9,497
All other countries | ​ |  | 5,362 | ​ | ​ | 11,486 | ​ | ​ | 16,848
Revenue | ​ | $ | 14,922 | ​ | $ | 11,522 | ​ | $ | 26,444
​ ​ CytoSorb Sales The Company sells its CytoSorb device using both its own sales force (direct sales) and through the use of distributors and/or strategic partners. The majority of sales of the device are outside the United States, as CytoSorb is not yet approved for commercial sale in the United States. However, in April 2020, the Company was granted Emergency Use Authorization (“EUA”) of CytoSorb for use in critically-ill patients infected with COVID-19 with imminent or confirmed respiratory failure by the United States Food and Drug Administration (the “FDA”). Direct sales outside the United States relate to sales to hospitals located in Germany, Switzerland, Austria, Poland, the Netherlands and the United Kingdom. Direct sales are fulfilled from the Company’s warehouse facility in Berlin, Germany. There are no formal sales contracts with any direct customers relating to product price or minimum purchase requirements. However, there are agreements in place with certain direct customers that provide for either free of charge product or rebate credits based upon achieving minimum purchase levels. The Company records the value of these items earned as a reduction of revenue, estimated at the time of sale. These customers submit purchase orders and the order is fulfilled and shipped directly to the customer. Prices to all direct customers are based on a standard price list based on the packaged quantity (6 packs versus 12 packs). Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. In general, the Company has formal written contracts with each of its distributors and strategic partners. These contracts have terms ranging from 1-5 years in length, with three years being the typical term. When a contract is not in place, the Company will ship product based upon the terms of an accepted purchase order. In addition, certain distributors are eligible for volume discount pricing if their unit sales are in excess of the base amount in the contract. Most distributor’s/strategic partner’s contracts have minimum annual purchase requirements in order to maintain exclusivity in their respective territories. There is no additional consideration or monetary penalty that would be required to be paid to CytoSorbents if a distributor does not meet the minimum purchase commitments included in the contract; however, at the discretion of the Company, the distributor may lose its exclusive rights in the territory if such commitments are not met. In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels. The Company does not currently incur any outside third-party incremental costs to obtain any of these contracts. The following table provides information about receivables and contract liabilities from contracts with customers: ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, 2025 |  | December 31, 2024
​ |  | (amounts in thousands)
Contract receivables | ​ | $ | 5,997 | ​ | $ | 4,427
Contract liabilities | ​ | $ | 403 | ​ | $ | 596
​ Contract receivables, which are included in accounts receivable on the condensed consolidated balance sheets, represent balances due from product sales to direct and distributor customers amounting to $6.0 million and $4.2 million as of September 30, 2025 and December 31, 2024, respectively, and billed and unbilled amounts due on government contracts amounting to $0.0 million and $0.2 million as of September 30, 2025 and December 31, 2024, respectively. Contract liabilities, which are included in accrued expenses and other current liabilities on the condensed consolidated balance sheets, represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements, which amounted to $0.2 million each as of September 30, 2025 and December 31, 2024, and deferred grant liability related to the billing on fixed price government contracts in excess of costs incurred, which amounted to $0.2 million and $0.4 million as of September 30, 2025 and December 31, 2024, respectively. Segment Information The Company operates and manages its business as one reportable segment and one operating segment, which is the business of developing, testing and selling blood purification medical devices. The Company’s chief operating decision maker, or CODM, is the Company’s Chief Executive Officer. The CODM assesses performance of the segment and decides how to allocate resources based on revenue growth, gross margin, operating expenses, adjusted net loss, adjusted EBITDA (as defined below) and cash burn (cash used in operating and investing activities) derived from the Company’s consolidated results of operations and cash flows and total assets of the segment. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. All material long-lived assets are located in New Jersey, United States and Berlin, Germany. Long-lived assets consist of property and equipment, net and operating lease right-of-use assets. Factors used in determining the reportable segment include the nature of the Company’s operations, the organizational and reporting structure and the type of information reviewed by the CODM to allocate resources and evaluate financial performance. The Company operates under one reportable business segment for which segment disclosure is consistent with the management decision making process that determines the allocation of resources and the measuring of performance. The Company operates as one reportable segment. Consisting of one operating segment, the components presented in the condensed consolidated statements of operations and comprehensive loss also present the components of the Company’s single operating segment. The CODM uses financial metrics to evaluate the Company’s spending and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization. The financial metrics used by the CODM in evaluating the Company’s spending and monitoring budget versus actual results are as follows: ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended |  | Nine Months Ended |
​ | ​ | September 30, | ​ | September 30, |
​ |  | 2025 |  | 2024 |  | 2025 |  | 2024 |
​ |  | (amounts, in thousands) | ​
Revenue | ​ | $ | 9,485 | ​ | $ | 8,613 | ​ | $ | 27,829 | ​ | $ | 26,444 | ​
Gross profit | ​ | $ | 6,666 | ​ | $ | 5,256 | ​ | $ | 19,687 | ​ | $ | 18,632 | ​
Gross margin | ​ |  | 70 | % |  | 61 | % |  | 71 | % |  | 70 | %
Total operating expenses | ​ | $ | 9,528 | ​ | $ | 10,086 | ​ | $ | 30,051 | ​ | $ | 31,689 | ​
Loss from operations | ​ | $ | (2,862) | ​ | $ | (4,830) | ​ | $ | (10,364) | ​ | $ | (13,057) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
EBITDA and Adjusted EBITDA (both non-GAAP measures): | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​
Net loss | ​ | $ | (3,170) | ​ | $ | (2,768) | ​ | $ | (2,701) | ​ | $ | (13,152) | ​
Interest expense, net | ​ |  | 645 | ​ |  | 588 | ​ |  | 1,866 | ​ |  | 775 | ​
Benefit from income taxes | ​ |  | (401) | ​ |  | — | ​ |  | (401) | ​ |  | — | ​
Depreciation and amortization expense | ​ |  | 364 | ​ |  | 383 | ​ |  | 1,137 | ​ |  | 1,181 | ​
Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure | ​ |  | (2,562) | ​ |  | (1,797) | ​ |  | (99) | ​ |  | (11,196) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Stock-based compensation | ​ |  | 488 | ​ |  | 891 | ​ |  | 1,879 | ​ |  | 2,840 | ​
Loss (gain) on foreign currency transactions | ​ | ​ | 64 | ​ |  | (2,650) | ​ | ​ | (9,128) | ​ |  | (680) | ​
Adjusted EBITDA, a non-GAAP measure | ​ | $ | (2,010) | ​ | $ | (3,556) | ​ | $ | (7,348) | ​ | $ | (9,036) | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Adjusted net loss, a non-GAAP measure: | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​ |  | ​ | ​
Net loss | ​ | $ | (3,170) | ​ | $ | (2,768) | ​ | $ | (2,701) | ​ | $ | (13,152) | ​
Stock-based compensation | ​ |  | 488 | ​ |  | 891 | ​ |  | 1,879 | ​ |  | 2,840 | ​
Loss (gain) on foreign currency transactions | ​ | ​ | 64 | ​ | ​ | (2,650) | ​ | ​ | (9,128) | ​ | ​ | (680) | ​
Adjusted net loss, a non-GAAP measure | ​ | $ | (2,618) | ​ | $ | (4,527) | ​ | $ | (9,950) | ​ | $ | (10,992) | ​
Total cash used in operating and investing activities | ​ | $ | (2,522) | ​ | $ | (2,762) | ​ | $ | (7,676) | ​ | $ | (12,632) | ​
​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | September 30, 2025 |  | December 31, 2024
​ | ​ | (amounts, in thousands)
Total assets | ​ | $ | 45,750 | ​ | $ | 47,372
​ Significant expense categories regularly provided to the CODM consist of the following: ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended | ​ | Nine Months Ended
​ | ​ | September 30, | ​ | September 30,
​ |  | 2025 |  | 2024 |  | 2025 |  | 2024
​ | ​ | (amounts, in thousands)
Research and development: |  | ​ | ​ | ​ | ​ | ​ | ​ | ​ |  |  | ​ |
Clinical expenses | ​ | $ | 719 | ​ | $ | 936 | ​ | $ | 2,510 | ​ | $ | 3,499
Other research and development expenses | ​ |  | 199 | ​ |  | 890 | ​ |  | 1,332 | ​ |  | 2,093
Total research and development | ​ | $ | 918 | ​ | $ | 1,826 | ​ | $ | 3,842 | ​ | $ | 5,592
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Selling, general and administrative | ​ |  |  | ​ |  | ​ | ​ |  |  | ​ |  |
Royalty expense | ​ | $ | 285 | ​ | $ | 354 | ​ | $ | 826 | ​ | $ | 1,594
Stock-based compensation | ​ |  | 376 | ​ |  | 843 | ​ |  | 1,435 | ​ |  | 2,792
Legal, financial and consulting | ​ |  | 1,061 | ​ |  | 824 | ​ |  | 3,063 | ​ |  | 2,325
Other general and administrative | ​ |  | 6,888 | ​ |  | 6,239 | ​ |  | 20,885 | ​ |  | 19,386
Total selling, general and administrative | ​ | $ | 8,610 | ​ | $ | 8,260 | ​ | $ | 26,209 | ​ | $ | 26,097
​ Amounts presented within research and development expenses in the table above are inclusive of stock-based compensation expense. Refer to Note 4, Common Stock, Stock-Based Compensation and Warrants, for additional information. Capital expenditures of the segment totaled $0.1 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively.

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