CytoSorbents Q1 2025 slides: Revenue dips 3% as company targets breakeven by year-end

Introduction & Market Context

CytoSorbents Corporation (NASDAQ:CTSO) presented its first quarter 2025 financial results on May 14, highlighting mixed performance as the blood purification technology company continues its push toward operational efficiency. The company reported a 3% year-over-year revenue decline while emphasizing progress in international markets and its path to near-breakeven operations by the second half of 2025.

The presentation comes amid challenging market conditions for CTSO, with the stock trading at $1.18 as of the most recent close, up 1.72% but still well below its 52-week high of $1.61. The company faces both regulatory hurdles for its DrugSorb-ATR product and commercial challenges in its core German market.

Quarterly Performance Highlights

CytoSorbents reported Q1 2025 product sales of $8.7 million, representing a 3% decrease year-over-year, though sales remained flat on a constant currency basis. The company maintained a healthy gross margin of 71%, consistent with its 2024 average but down from 77% in the prior-year quarter.

As shown in the following financial performance overview:

The company’s operating metrics showed notable improvement, with total operating expenses decreasing by 12% to $10.1 million and operating loss improving by 17% to $3.9 million compared to Q1 2024. Adjusted EBITDA loss also improved by 17% to $2.7 million, demonstrating the company’s focus on operational efficiency.

The following slide illustrates these operational improvements:

CEO Dr. Phillip Chan emphasized the company’s value proposition during the presentation, highlighting CytoSorb’s established international presence with over $35 million in high-margin sales and more than 270,000 devices used across 70+ countries.

Regulatory Updates and Product Pipeline

A significant focus of the presentation was the regulatory status of DrugSorb-ATR, the company’s investigational device designed to reduce bleeding during cardiac surgery for patients on blood thinners. The company disclosed that the FDA issued a denial letter for its De Novo submission on April 25, 2025, but plans to file a formal appeal within 60 days.

The following slide explains the clinical need that DrugSorb-ATR addresses:

Despite the regulatory setback, CytoSorbents continues to build clinical evidence supporting DrugSorb-ATR’s efficacy and safety. The company highlighted its STAR Registry with over 600 subjects enrolled and published data showing significant reductions in severe bleeding with excellent safety outcomes.

The company presented compelling real-world evidence to support its appeal:

The Health Canada submission for DrugSorb-ATR remains in advanced review, with the company expecting regulatory decisions in both the U.S. and Canada during 2025.

Strategic Initiatives

CytoSorbents outlined several strategic initiatives aimed at driving future growth. The company is implementing a three-pronged approach for its CytoSorb product, focusing on the "Right Patient," "Right Timing," and "Right Dose" to achieve optimal clinical outcomes.

This integrated approach is illustrated in the following diagram:

The company is also actively addressing challenges in its German direct sales market while highlighting strong performance from international distribution and other direct sales countries. Management expressed confidence in returning the German market to growth in the second half of 2025.

Geographic expansion continues to be a priority, with the company establishing a new subsidiary in Dubai to strengthen its presence in the Middle East. Additionally, CytoSorbents is preparing for the potential launch of DrugSorb-ATR through a controlled market release strategy, KOL engagement, and talent recruitment.

Financial Position and Outlook

CytoSorbents reported a strengthened balance sheet with $13.1 million in cash, cash equivalents, and restricted cash as of March 31, 2025. The company received $6.8 million from a successful rights offering and an additional $1.7 million in April from the sale of NOL and R&D credits.

The following slide details the company’s improved financial position:

Looking forward, CytoSorbents reiterated its goal of reaching near-breakeven operations in the second half of 2025. This target aligns with the company’s broader strategy of achieving financial independence while continuing to invest in its product pipeline.

The company’s value proposition and forward-looking strategy are summarized in this comprehensive overview:

While the Q1 2025 earnings report showed a revenue miss compared to analyst expectations ($8.7 million versus forecasted $10.82 million) and an adjusted EPS of -$0.06 that missed the -$0.05 consensus, management remains focused on operational efficiency and strategic growth initiatives to drive long-term value for shareholders.

Full presentation:

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