CytoSorbents — Third Quarter 2026 Earnings Summary

Financial Performance:

• Q3 2026 revenue was $9.7 million, a 3% increase compared to $9.5 million in Q3 2025.
• Gross margin improved to 75% in Q3 2026, up from 73% in Q2 2026 and 70% in Q3 2025.
• Total operating expenses decreased 11% to $8.5 million in Q3 2026 from $9.5 million in Q3 2025; excluding $0.25 million in restructuring charges, expenses decreased 13%.
• Operating loss improved 59% to $1.2 million in Q3 2026 versus $2.9 million in Q3 2025.
• Net loss improved 42% to $1.8 million ($0.58 per share) in Q3 2026 compared to $3.2 million ($1.01 per share) in Q3 2025.
• Adjusted net loss improved 42% to $1.5 million ($0.48 per share) in Q3 2026 compared to $2.6 million ($0.83 per share) in Q3 2025.
• Adjusted EBITDA loss improved 86% to $0.3 million in Q3 2026 compared to $2.0 million in Q3 2025.
• Total cash, cash equivalents, and restricted cash was approximately $5.7 million as of September 30, 2026, down from $5.9 million at June 30, 2026.
• The company generated positive operating cash flow of approximately $43,000 in Q3 2026, excluding $251,000 in restructuring-related payments; total cash burn inclusive of restructuring payments was approximately $200,000.
• For the nine months ended September 30, 2026, revenue was $28.2 million compared to $27.8 million in the prior year period.
• Nine-month gross margin improved to 73% compared to 71% in the prior year period.
• Nine-month operating expenses decreased 9% to $27.4 million, and operating loss improved 34% to $6.9 million from $10.4 million.
• Nine-month net loss was $11.4 million ($3.62 per share) compared to $2.7 million ($0.87 per share) in the prior year, primarily due to a $1.9 million non-cash foreign currency loss in 2026 versus a $9.1 million gain in 2025.
• Nine-month Adjusted EBITDA loss improved 45% to $4.0 million compared to $7.3 million in the prior year period.
• Inventory decreased from $5.3 million at year-end 2025 to $3.2 million at September 30, 2026.
• Current maturities of long-term debt increased to $17.5 million as of September 30, 2026, compared to $0 in December 2025.

Guidance and Future Outlook:

• The company achieved its objective of operating cash flow breakeven in the second half of 2026.
• Management aims to sustain operating cash flow at or near breakeven while selectively investing to accelerate sales growth.
• A new De Novo submission to the FDA for DrugSorb-ATR is expected in early 2027.
• A separate De Novo submission for the removal of direct oral anticoagulants (apixaban and rivaroxaban) is expected next year.
• Management expects to add two sales representatives in Germany next month and two more through early 2027.
• The company is evaluating opportunities to advance HemoDefend-BGA through additional non-dilutive government funding, commercial partnerships, or licensing arrangements.

Business Segments and Product Lines:

• Distributor and strategic partner sales grew 16% year-over-year in Q3 2026.
• Distributor and strategic partner sales grew 18% year-over-year and 10% sequentially in Q3 2026.
• Direct sales outside Germany increased 4% year-over-year in Q3 2026.
• Sales in Germany declined 20% year-over-year in Q3 2026, representing 24% of quarterly sales.
• Distributor and strategic partner sales plus direct sales outside Germany accounted for 76% of quarterly sales.
• CytoSorb is approved in the European Union and distributed in over 70 countries, with over 300,000 devices used cumulatively.
• CytoSorb received FDA Emergency Use Authorization for adult critically ill COVID-19 patients with respiratory failure but is not yet approved or cleared in the U.S.
• DrugSorb-ATR is an investigational device in the U.S. and Canada with two FDA Breakthrough Device Designations for removing ticagrelor and direct oral anticoagulants.
• HemoDefend-BGA is a blood purification technology developed with approximately $16 million in prior non-dilutive U.S. government funding designed to remove anti-A and anti-B antibodies.
• Alex Tiefenbacher was appointed Senior Vice President of Direct Sales to lead the direct sales organization in Germany and internationally.

Market and Competitive Landscape:

• The initial addressable market for DrugSorb-ATR in the U.S. and Canada is estimated at approximately $300 million, potentially expanding to $1-2 billion with label expansion.
• Real-world data presented at the European Society of Cardiology congress showed a 37% relative reduction in severe BARC-4 bleeding with intraoperative CytoSorb use in patients exposed to Brilinta.
• The clinical evidence base is expanding with new data presented at the EACTS Annual Meeting and ESICM LIVES 2026 congress regarding applications in blood thinner removal, post-operative shock, VA-ECMO support, heart transplantation, sepsis, liver support, and VV-ECMO.
• The company is working to finalize an animal study protocol with the FDA to collect additional mechanistic data for DrugSorb-ATR.

Risks and Challenges:

• Sales in Germany declined 20% year-over-year due to a smaller, more focused sales force and reduced territory coverage following commercial restructuring.
• Net loss for the nine months ended September 30, 2026, was significantly impacted by a $1.9 million non-cash foreign currency loss compared to a $9.1 million gain in the prior year.
• The company faces the challenge of sustaining operating cash flow breakeven while managing quarterly fluctuations in revenue, collections, and working capital.
• Forward-looking statements highlight risks including the ability to obtain U.S. FDA and Health Canada marketing authorization, sustain cash flow break-even, maintain Nasdaq listing compliance, and secure necessary financing or strategic partnerships.

Management Commentary and Tone:

• Dr. Phillip Chan, CEO, stated that Q3 2026 marked an important financial milestone with the achievement of operating cash flow breakeven, reflecting disciplined execution and improvements in the underlying business.
• Management emphasized that every dollar of operating cash burn eliminated reduces future financing needs and positions the company to capture more value from future growth.
• Dr. Chan noted that the company is entering its next phase from a stronger operational position with a more efficient cost structure.
• Management expressed confidence that the combination of renewed growth in Germany, sustained international momentum, an expanding clinical evidence base, and a leaner cost structure positions the core CytoSorb franchise to accelerate revenue growth.
• The company views its four distinct value drivers as providing multiple potential pathways to shareholder value creation, reducing dependence on any single outcome.

Other Key Points:

• A 1-for-20 reverse stock split was effected on September 8, 2026; all per share amounts reflect this adjustment.
• The company incurred $0.25 million in restructuring charges in Q3 2026 and $0.561 million for the nine months ended September 30, 2026.
• Headcount was reduced by 24% since September 2025.
• The company received helpful FDA feedback in July regarding the clinical development pathway for HemoDefend-BGA.
• A live conference call and webcast were scheduled for November 12, 2026, at 4:30 PM ET.
• Total liabilities increased to $39.5 million as of September 30, 2026, from $38.3 million as of December 31, 2025.
• Stockholders' equity turned to a deficit of $2.3 million as of September 30, 2026, from positive equity of $5.9 million as of December 31, 2025.