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CTSO · Cytosorbents Corp

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$0.40 +0.04 (+10.38%) At close · Aug 14
Market Cap
$25.13M
Shares
62.84M
All earnings calls

Earnings call · FY2026 Q1

Cytosorbents Corp Q1 FY2026 Earnings Call

Cytosorbents Corp Q1 FY2026 Earnings Call

Concluded May 13, 2026
May 13, 2026 29 turns
Period
FY2026 Q1
Runtime
Sources
3 artifacts

Executive readout · one minute

What matters this quarter

CytoSorbents reported Q1 2026 revenue of $8.9 million, up 2% year-over-year, with 13% growth in direct international sales outside Germany, while Germany sales declined slightly and distributor sales were held flat by approximately $0.5 million in Middle East order delays tied to U.S.-Iran war disruption. The company is selectively rebuilding its German sales force and continues to pursue a path to U.S. approval for DrugSorb-ATR following the FDA's August 2025 appeal decision.

DrugSorb-ATR U.S. regulatory pathway 53 Core CytoSorb international commercial performance 28 Geopolitical disruption in the Middle East 24 Gross margin and inventory management 20 Germany commercial restructuring 16 Direct International growth outside Germany 8

Management tone

Positive

Net tone +32 · low hedging

Grounding quotes
  • “Revenue grew 2% year-over-year to $8.9 million, despite several temporary external headwinds”
  • “Direct International business outside Germany, which grew 13% year-over-year”
  • “We continue to believe the unmet need here is substantial. And importantly, we now have clear direction from FDA regarding the path forward”
  • “We believe this type of data is increasingly important in today's health care environment where hospitals are under growing pressure to improve efficiency”

Research coverage

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Revenue $8.86M +1.6% YoY
Diluted EPS -$0.08
Gross margin 69.2% -1.9 pp YoY
Net income -$5.13M

Research materials

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Key takeaways

What improved, and what deserves a closer read.

Constructive signals

  • Q1 2026 revenue grew 2% year-over-year to $8.9 million, with Direct International (ex-Germany) up 13%
  • Operating loss narrowed to $3.0 million from $3.9 million in Q1 2025, and adjusted EBITDA loss improved to $2.2 million from $2.7 million
  • Adjusted net loss improved to $3.4 million ($0.05/share) from $3.7 million ($0.06/share) year-over-year
  • Q1 cash burn was approximately $1.1 million (excluding $0.3 million in restructuring payments), with $6.4 million in cash and equivalents on hand
  • FDA appeal decision identified no safety concerns for DrugSorb-ATR and provided a path forward, with company citing a potential parallel path to U.S. approval
  • Company reiterated goal of achieving operating cash flow breakeven in the second half of 2026 following 2025 headcount reduction of ~10%

Risks & pressure points

  • Germany sales declined year-over-year (despite operational progress described)
  • Net loss widened to $5.1 million ($0.08/share) from $1.5 million ($0.02/share), driven primarily by non-cash foreign currency transaction changes
  • Gross margin declined to 69% from 71% in Q1 2025 due to intentional production slowdown to reduce inventory
  • Approximately $0.5 million in expected distributor orders delayed by geopolitical disruption linked to the U.S.-Iran war, affecting Dubai subsidiary and broader EMEA
  • Cash and equivalents declined to $6.4 million as of March 31, 2026 from $7.8 million at December 31, 2025
  • DrugSorb-ATR remains investigational and not commercially approved in any geography, with FDA having upheld the original application denial in August 2025

Key moments

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“DrugSorb-ATR represents a potentially transformational opportunity in cardiac surgery and blood thinner removal. We continue to believe the unmet need here is substantial. And importantly, we now have clear direction from FDA regarding the path forward.” Phillip Chan, CEO

Quarter detail

How the reported period landed and where the business moved.

Revenue · regions

All Other Countries$6.13M +4.5% YoY
Germany$2.61M -6.5% YoY
United States$118,000 +87.3% YoY
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