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Aug 6, 2026, 4:19 PM ETHealthcare

CytoSorbents — Second Quarter 2026 Earnings Summary

CTSOCYTOSORBENTS CORP
Source

Financial Performance

  • Revenue was $9.6 million, unchanged from $9.6 million in Q2 2025.
  • Gross margin improved to 73% in Q2 2026, up from 69% in Q1 2026 and 71% in Q2 2025.
  • Operating loss improved by 27% to $2.6 million in Q2 2026, compared to $3.6 million in Q2 2025.
  • Net loss was $4.4 million ($0.07 per share) in Q2 2026, compared to net income of $1.9 million ($0.03 per share) in Q2 2025, driven by non-cash foreign currency translation losses.
  • Adjusted net loss improved by 22% to $2.8 million ($0.05 per share) in Q2 2026, compared to $3.7 million ($0.06 per share) in Q2 2025.
  • Adjusted EBITDA loss improved by 38% to $1.6 million in Q2 2026, compared to $2.6 million in Q2 2025.
  • Total cash, cash equivalents, and restricted cash was approximately $5.9 million as of June 30, 2026, down from $6.3 million at March 31, 2026.
  • Total cash burn in Q2 2026 was $0.4 million, inclusive of approximately $0.2 million in restructuring-related payments; cash burn excluding restructuring payments was approximately $0.2 million.
  • Long-term debt decreased to $3.1 million (net of current portion) as of June 30, 2026, from $16.7 million as of December 31, 2025.
  • Stockholders' equity turned to a deficit of $0.8 million as of June 30, 2026, compared to positive equity of $5.9 million as of December 31, 2025.

Guidance and Future Outlook

  • Management expects to achieve operating cash flow breakeven in the second half of 2026.
  • The company plans to add three to five new sales representatives in Germany through early 2027 to restore full country coverage and drive a return to growth in the region.
  • Management anticipates completing required testing and submitting a new De Novo application for DrugSorb-ATR in early 2027.
  • The company intends to regain compliance with Nasdaq listing requirements in the near future.

Business Segments and Product Lines

  • Distributor and strategic partner sales grew 16% in Q2 2026 despite geopolitical disruption in the Middle East.
  • Direct sales outside of Germany grew 9% in Q2 2026.
  • Sales in Germany decreased 24% in Q2 2026 due to a smaller, more focused sales force following restructuring.
  • Adoption of the PuriFi® pump platform and HotSwap® technology is increasing, simplifying therapy delivery and encouraging earlier intervention.
  • DrugSorb-ATR is under development for removing blood thinners (ticagrelor, apixaban, rivaroxaban) during cardiopulmonary bypass in urgent cardiothoracic surgery.
  • HemoDefend-BGA, a technology for producing universal blood products, received constructive FDA feedback in July 2026 regarding its clinical pathway.
  • CytoSorb is approved in the EU and distributed in over 70 countries, with cumulative usage exceeding 300,000 devices.

Market and Competitive Landscape

  • The U.S. and Canada represent an initial market opportunity of approximately $500 million to $1 billion for DrugSorb-ATR upon approval.
  • HemoDefend-BGA has the potential to simplify blood inventories by reducing the need for four types of plasma and platelets to one universal product each.
  • The company is actively pursuing regulatory approval in the U.S. and Canada, with Health Canada approval expected to follow FDA visibility.

Risks and Challenges

  • Revenue in Germany remains depressed due to the reduced size of the sales force, though efficiency has improved.
  • The company faces risks related to obtaining FDA and Health Canada marketing authorization for DrugSorb-ATR.
  • Achieving operating cash flow breakeven and appropriate financing remain critical challenges.
  • Foreign currency translation fluctuations significantly impacted net income, turning a profit into a loss.
  • The company has not yet achieved compliance with Nasdaq listing requirements.

Management Commentary and Tone

  • Dr. Phillip Chan, CEO, expressed encouragement regarding improved productivity and sales execution, noting that the company is better positioned for success than a year ago.
  • Management highlighted disciplined execution across manufacturing optimization, working capital management, and cost controls as drivers for improved margins and reduced cash burn.
  • Dr. Chan stated that the company remains intensely focused on disciplined execution to stabilize the business and unlock value through four independent drivers.
  • The tone reflects confidence in the strategy to achieve breakeven and expand into the U.S. market, while acknowledging that significant work remains.

Other Key Points

  • The company reduced its workforce by approximately 23% since September 2025 to create a leaner organization.
  • CytoSorbents has received two FDA Breakthrough Device Designations for DrugSorb-ATR: one for ticagrelor removal and another for DOAC removal.
  • HemoDefend-BGA was developed with approximately $16 million of prior non-dilutive U.S. government funding.
  • The company is exploring commercial partnerships, licensing opportunities, and government funding for HemoDefend-BGA.
  • Two FDA pre-submission meetings were scheduled for August 2026 to discuss mechanistic data for the Brilinta® program and potential parallel De Novo submission for DOACs.
  • The company reported a loss on abandoned patents of $338,000 in the six months ended June 30, 2026.
CytoSorbents — Second Quarter 2026 Earnings Summary