Summary of CytoSorbents Conference Call Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Medical Technology, specifically blood purification - **Core Product**: CytoSorb, a blood purification technology designed to remove toxins and harmful substances from blood, particularly in critical care settings and cardiac surgery [2][3] Key Points and Arguments Financial Performance - **Core Product Sales**: CytoSorb achieved record sales of $37 million over the trailing twelve months with a gross margin of 71% [3] - **Recent Revenue**: Third quarter revenue was $9.5 million, a 10% increase from $8.6 million year-over-year, driven by strong sales in distributor territories and favorable currency exchange rates [20] - **Cash Position**: As of the end of the third quarter, the company had $9.1 million in cash, with an amended credit agreement providing an additional $2.5 million and extending the interest-only period to January 2027 [20][39] Product Development and Regulatory Path - **DrugSorb ATR**: An investigational device aimed at reducing bleeding severity in patients on blood thinners undergoing CABG surgery, with FDA breakthrough device designation [3][11] - **Regulatory Timeline**: A new de novo submission is expected in 2026, with a regulatory decision anticipated mid-2026 following a 150-day review process [17][18] - **FDA Collaboration**: The company has had positive discussions with the FDA, addressing previous submission issues and focusing on new efficacy data [25][26] Market Opportunities - **Critical Care Market**: CytoSorb targets severe inflammation in critical care, impacting up to 60% of ICU patients, with applications in conditions like sepsis, burn injury, and acute respiratory distress syndrome [7][8][10] - **Sepsis Treatment**: Sepsis accounts for roughly half of CytoSorb's treatments, representing a significant market opportunity as it is a leading cause of death worldwide [10][42] - **Blood Thinner Market**: DrugSorb ATR addresses a $1 billion total addressable market in the U.S. for patients on blood thinners, particularly during urgent surgeries [11][12] Competitive Landscape - **Industry Positioning**: CytoSorbents aims to differentiate itself from competitors focused on chronic kidney disease, which typically impacts only 10-15% of ICU patients, compared to the broader critical care market [9] Future Growth Strategy - **Sales Strategy**: The company plans a controlled market release for DrugSorb ATR, focusing on clinical accounts and gradually expanding its sales force based on adoption rates [28][32] - **Expansion Plans**: There are intentions to target additional blood thinners and expand applications beyond cardiac surgery [36][37] Additional Important Information - **Technological Advantage**: CytoSorb's technology is described as having a significantly larger surface area for toxin removal compared to traditional dialysis, enhancing its effectiveness in critical care [5][6] - **Clinical Data**: The company has a robust body of clinical data supporting its technology, with hundreds of publications in various applications [9] Conclusion - CytoSorbents is positioned for growth with a strong product offering in the critical care market, a solid financial foundation, and a clear regulatory pathway for its investigational device. The company aims to achieve cash flow breakeven by Q1 2026 while addressing significant unmet medical needs in sepsis and surgical bleeding management [4][22][40]

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Core Insights - CytoSorbents Corporation will present and engage in one-on-one meetings with investors at the Jefferies Global Healthcare Conference from November 17-20, 2025 in London [1][9] - The presentation is scheduled for November 18, 2025, at 12:30 PM GMT / 7:30 AM ET, with a live webcast available [2] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [3] - The company's proprietary technology utilizes biocompatible, highly porous polymer beads to remove toxic substances from blood and bodily fluids [3] - Key applications include the removal of blood thinners during cardiothoracic surgery and the elimination of inflammatory agents in critical illnesses such as sepsis and liver failure [3] Product Information - The lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries, with nearly 300,000 devices used to date [4] - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients in the U.S., although it is not yet fully approved in the U.S. [4] - The company is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [5] Research and Development - CytoSorbents has a range of marketed products and ongoing developments protected by numerous patents and trademarks [6] - The company is actively pursuing regulatory approvals for its products in the U.S. and Canada [5]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $9.5 million, an increase of 10% from $8.6 million in Q3 2024, or 4% on a constant currency basis [5][11] - Gross margin improved to approximately 70% compared to 61% in Q3 2024 [5][11] - Adjusted net loss for the quarter improved to $2.6 million, or $0.04 per share, compared to an adjusted net loss of $4.5 million, or $0.08 per share in the prior year [14] Business Line Data and Key Metrics Changes - Core product sales reached a record $37 million for the trailing 12 months as of September 30, 2025, up from $33.8 million a year ago [4][6] - Distributor and partner sales grew 14% to $15.6 million, while direct sales outside Germany rose approximately 24% to $8.8 million [6] - Sales in Germany declined modestly by 3% to $12.6 million [6] Market Data and Key Metrics Changes - CytoSorb is approved in the European Union and available in over 70 countries, with nearly 300,000 treatments performed to date [4] - The U.S. market opportunity for DrugSorb ATR is initially estimated at $300 million, potentially exceeding $1 billion as Brilinta becomes generic [9] Company Strategy and Development Direction - The company focuses on five key initiatives: returning to higher growth in CytoSorb, obtaining U.S. marketing approval for DrugSorb ATR, achieving near-term cash flow break-even, strengthening the balance sheet, and maximizing shareholder value [5][19] - A strategic workforce and cost reduction program has been implemented, including a workforce reduction of approximately 10% [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow break-even beginning in Q1 2026, supported by improvements in operating margins and cash burn [15][18] - The company anticipates a mid-2026 regulatory decision for DrugSorb ATR following a new De Novo filing in Q1 2026 [10] Other Important Information - The company amended its loan agreement with Avenue Capital Group, providing immediate funding of $2.5 million and extending the interest-only period to December 31, 2026 [17] - The company recognizes the need for improved performance in Germany and is restructuring its sales team and approach [6][7] Q&A Session Summary Question: What is the expected gross margin for Q4 and 2026? - Management is pleased with the current 70% gross margin and sees opportunities for improvement as efficiencies increase and volumes rise [23] Question: Are there any milestones for the German sales force restructuring? - Management indicated it is too early to assess the full impact but noted improvements in representative performance and efficiency [24] Question: What is the difference between the pre-submission package and the full application for the FDA? - The pre-submission package aims to align with FDA concerns and guidance, ensuring no surprises in the final De Novo submission [25][26] Question: Feedback from the World Sepsis Day webcast? - The response has been excellent, highlighting the broad applications of CytoSorb in treating sepsis and septic shock [27][29]

Financial Performance - Third quarter 2025 revenue was $9.5 million, representing a 10% year-over-year increase from $8.6 million in Q3 2024[5] - Gross margin improved to 70% in Q3 2025, up from 61% in Q3 2024, due to resolved manufacturing issues and improved operational efficiencies[5] - Operating loss decreased to $2.9 million in Q3 2025, compared to $4.8 million in Q3 2024, driven by better gross margins and lower operating expenses[5] - Adjusted net loss improved to $2.6 million or $0.04 per share, compared to an adjusted net loss of $4.5 million or $0.08 per share in Q3 2024[5] - CytoSorbents reported revenue of $9.485 million for Q3 2025, a 10.1% increase from $8.613 million in Q3 2024[28] - Gross profit for Q3 2025 was $6.666 million, compared to $5.256 million in Q3 2024, reflecting a gross margin improvement[28] - The company incurred a net loss of $3.170 million in Q3 2025, compared to a net loss of $2.768 million in Q3 2024[28] - For the nine months ended September 30, 2025, the net loss was $2,701,000, a significant improvement compared to a net loss of $13,152,000 for the same period in 2024[30] - The company reported stock-based compensation of $1,879,000 for the nine months ended September 30, 2025, down from $2,840,000 in the same period of 2024[30] - The adjusted EBITDA for the nine months ended September 30, 2025, was $(7,348,000), an improvement from $(9,036,000) in the same period of 2024[31] - The basic net loss per common share for the three months ended September 30, 2025, was $(0.05), consistent with the same period in 2024[31] Cash Flow and Assets - The company expects to reach cash flow breakeven in Q1 2026 following a workforce reduction of approximately 10% and a cost reduction program[7] - Proforma cash, cash equivalents, and restricted cash was $11.6 million on September 30, 2025, assuming the additional term loan was drawn[6] - Cash and cash equivalents increased to $7.536 million as of September 30, 2025, up from $3.280 million at the end of 2024[27] - Cash, cash equivalents, and restricted cash at the end of the period were $9,058,000, compared to $12,168,000 at the end of September 30, 2024[30] - The net cash used in operating activities for the nine months ended September 30, 2025, was $7,552,000, compared to $12,087,000 for the same period in 2024[30] Liabilities and Equity - Total current assets decreased slightly to $21.313 million as of September 30, 2025, from $21.604 million as of December 31, 2024[27] - Total liabilities increased to $36.730 million as of September 30, 2025, compared to $36.265 million at the end of 2024[27] - The total stockholders' equity as of September 30, 2025, was $9,020,000, a decrease from $11,586,000 as of June 30, 2025[29] Regulatory and Product Development - The company submitted a De Novo pre-submission package for DrugSorb™-ATR to the FDA, with a regulatory decision anticipated by mid-2026[5][11] - CytoSorbents is actively pursuing regulatory approval for the DrugSorb™-ATR system with the U.S. FDA and Health Canada[20] - The company has multiple products under development, including ECOS-300CY®, CytoSorb-XL™, and DrugSorb™, protected by numerous patents[21] Clinical Programs and Research - Recent clinical data publications reinforce the effectiveness of CytoSorbents' therapies in managing sepsis and septic shock, highlighting significant reductions in mortality rates[14] - The company plans to expand clinical programs across all applications to improve patient outcomes and support healthcare workers globally[15] Financing and Credit - An amended credit agreement with Avenue Capital Group provides an additional $2.5 million in term loan capital and extends the interest-only period to December 31, 2026[8] - The company reported proceeds from the exercise of common stock warrants amounting to $1,439,000 for the nine months ended September 30, 2025[30] - The company incurred foreign currency transaction gains of $9,128,000 for the nine months ended September 30, 2025, compared to gains of $680,000 in the same period of 2024[30]

Financial Performance - Total revenue for the nine months ended September 30, 2025, was $27.8 million, an increase of $1.4 million, or 5.2%, compared to the prior year[105]. - Gross profit for the same period was $19.7 million, reflecting a 5.7% increase year-over-year, with a gross margin of 71%[105]. - For the three months ended September 30, 2025, total revenue was approximately $9.5 million, an increase of approximately $0.9 million, or 10.1%, compared to the same period in 2024[109]. - Gross profit for the three months ended September 30, 2025, was approximately $6.7 million, an increase of 26.8% compared to $5.2 million for the same period in 2024, with gross margins improving to 70.3% from 61.0%[110]. - Total revenue for the nine months ended September 30, 2025, was approximately $27.8 million, a 5.2% increase from $26.4 million in 2024, driven by growth in European territories[116]. - Gross profit for the nine months ended September 30, 2025, was approximately $19.7 million, an increase of 5.7% from $18.6 million in 2024, with gross margins slightly improving to 70.7%[117]. Operating Expenses - The loss from operations improved by 20.6% to approximately $10.4 million, driven by a 5.2% increase in total revenue and a 5.2% reduction in total operating expenses[105]. - The cost of goods sold for the three months ended September 30, 2025, was $2.8 million, representing 29.7% of revenue, down from 39.0% in the prior year[108]. - Research and development expenses for the three months ended September 30, 2025, were $918,000, a decrease from $1.8 million, representing 9.7% of revenue compared to 21.2% in 2024[108]. - Research and development expenses decreased by 49.7% to approximately $0.9 million for the three months ended September 30, 2025, down from $1.8 million in 2024, due to the completion of the STAR-T clinical trial[111]. - Selling, general and administrative expenses increased by 4.2% to approximately $8.6 million for the three months ended September 30, 2025, compared to $8.3 million in 2024, primarily due to regulatory submission costs for DrugSorb-ATR[112]. - Loss from operations decreased by 40.7% to approximately $2.9 million for the three months ended September 30, 2025, from $4.8 million in 2024, attributed to a 5.5% reduction in operating expenses and increased gross profit[114]. - Research and development costs for the nine months ended September 30, 2025, were approximately $3.8 million, a decrease of 31.3% from $5.6 million in 2024, due to reduced clinical trial costs[118]. Strategic Plans and Market Opportunities - The Company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada, with an initial estimated total addressable market of $300 million, potentially growing to over $1 billion[103]. - The Company plans to file a new De Novo application for DrugSorb-ATR with the FDA, with a regulatory decision expected in mid-2026[107]. - The company expects a regulatory decision for DrugSorb-ATR in the U.S. by mid-2026 following a 150-day review process[138]. - Future capital requirements may depend on expanding the customer base and sales force, as well as obtaining regulatory approval for new products[137]. - The company announced plans to file a new De Novo application for DrugSorb-ATR with the FDA after the previous application was denied[138]. Workforce and Cost Management - A strategic workforce and cost reduction plan was initiated, reducing the workforce by approximately 10% and aiming for operating cash flow break-even in the first quarter of 2026[107]. - The company expects to reach operating cash flow break-even in the first quarter of 2026 following a strategic workforce and cost reduction plan that includes a 10% workforce reduction[132]. - The company has taken actions to achieve cash flow breakeven, but failure to do so may necessitate slowing sales and marketing expansion or reducing headcount[137]. Financial Position and Liquidity - As of September 30, 2025, the company had current assets of approximately $21.3 million and current liabilities of approximately $12.6 million, indicating a healthy liquidity position[124]. - As of September 30, 2025, the company had approximately $9.1 million in cash, including $7.6 million in unrestricted cash and cash equivalents[133]. - The total amount of debt drawn under the Loan and Security Agreement was $15.0 million as of September 30, 2025, which would increase to $17.5 million on a proforma basis with an additional $2.5 million from the Amended Loan and Security Agreement[136]. - The company has approximately $1.5 million in non-current restricted cash as of September 30, 2025[135]. - The company has no assurance of securing funding on acceptable terms, which may impact its operational strategies[137]. Currency and Foreign Transactions - Gain on foreign currency transactions for the nine months ended September 30, 2025, was approximately $9.1 million, compared to a gain of $0.7 million in 2024, linked to an increase in the Euro to U.S. dollar exchange rate[122]. Funding and Financing Considerations - The company is considering various sources of liquidity, including public or private equity offerings and debt financing, but faces potential dilution for shareholders[137]. - The company filed a pre-submission meeting request with the FDA on November 7, 2025, to discuss the requirements for the new De Novo submission[138].

Core Insights - CytoSorbents Corporation honors the legacy of Dr. Robert Hawes Bartlett, a pivotal figure in critical care medicine and former Chief Medical Officer, who passed away at age 86 [1][2] - Dr. Bartlett was instrumental in the development and clinical trials of CytoSorb®, a blood purification technology that has been used to treat severe conditions, including during the COVID-19 pandemic [1][3] - The company is advancing its investigational device, DrugSorb™-ATR, aimed at reducing perioperative bleeding in high-risk surgeries [5][6] Company Overview - CytoSorbents Corporation specializes in blood purification technologies for life-threatening conditions in intensive care and cardiac surgery [3] - The company's lead product, CytoSorb®, is approved in the European Union and has been used in nearly 300,000 procedures globally [4] - CytoSorbents is developing additional products, including DrugSorb™-ATR, which has received FDA Breakthrough Device Designations for specific anticoagulant removals [5][6] Contributions of Dr. Bartlett - Dr. Bartlett is recognized as the father of extracorporeal membrane oxygenation (ECMO), a technology that has saved over 100,000 lives worldwide [1][2] - His work included leading clinical trials that supported the approval of CytoSorb® and expanding its use in critical care settings [1][2] - Dr. Bartlett's vision included the combination of CytoSorb with ECMO to enhance treatment for severe acute respiratory distress syndrome (ARDS) [1][2] Future Directions - The company aims to further develop its technologies and expand regulatory approvals for its products in the U.S. and Canada [5][6] - CytoSorbents is focused on leveraging its blood purification technologies to address critical illnesses that currently have limited treatment options [3][4]

Core Insights - CytoSorbents Corporation will have a significant scientific presence at the upcoming EACTS Annual Meeting, showcasing its advancements in blood purification technologies for cardiac surgery [1][2][3] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [10] - The company’s lead product, CytoSorb®, is CE-mark approved in the EU and distributed in over 70 countries, with nearly 300,000 devices used to date [11] - CytoSorbents is also developing the DrugSorb™-ATR system for antithrombotic drug removal, which has received two FDA Breakthrough Device Designations [12] Upcoming Events - The EACTS Annual Meeting will take place from October 8–11, 2025, in Copenhagen, Denmark, expected to attract over 5,000 attendees [1] - CytoSorbents will present two high-profile scientific presentations and host a lunch symposium discussing the role of hemoperfusion technologies in cardiac surgery [2][4] Scientific Presentations - Presentations will include data on the intraoperative removal of direct oral anticoagulants in urgent cardiothoracic surgery and the impact of dual antiplatelet therapy on perioperative bleeding [4][6] - The first randomized controlled trial data will demonstrate the effectiveness of DrugSorb™-ATR in reducing levels of direct oral anticoagulants during urgent cardiac surgery [6] Symposium Topics - The lunch symposium will cover topics such as improving outcomes for endocarditis patients and the combination of VA ECMO with hemoadsorption in cardiogenic shock patients [5][7]

Core Viewpoint - CytoSorbents Corporation is making progress in obtaining regulatory approval for its DrugSorb-ATR device, which aims to address significant medical needs in intensive care and cardiac surgery by removing blood thinners to reduce perioperative bleeding [2][3][4]. Regulatory Update - The FDA upheld its previous denial of the De Novo application for DrugSorb-ATR but found no safety issues, indicating a need for additional information to support the desired label indication [2][4]. - The company plans to file a new De Novo application that will include new real-world data supporting the device's clinical performance, which was not available during the original submission [4]. - A pre-submission meeting with the FDA is anticipated in Q4 2025 to confirm requirements for the new application, with a standard regulatory decision expected by mid-2026 [4]. Company Strategy - The company is focused on collaborating with both the FDA and Health Canada to secure marketing authorization for DrugSorb-ATR while also driving growth in its core business [3][4]. - Efforts are being made to improve product gross margins, control costs, and manage the core business towards near breakeven as 2025 concludes [3]. Product Overview - CytoSorbents specializes in blood purification technologies that remove toxic substances from blood, with applications in critical illnesses such as sepsis and trauma [5][6]. - The DrugSorb-ATR system is designed to reduce the severity of perioperative bleeding in high-risk surgeries due to blood-thinning medications and has received FDA Breakthrough Device Designation [7]. Market Presence - CytoSorb, the company's lead product, is approved in the EU and distributed in over 70 countries, with nearly 300,000 devices used cumulatively [6]. - The company has a range of marketed products and ongoing developments protected by numerous patents [8].