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Cytosorbents (NasdaqCM:CTSO) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker3Good afternoon, ladies and gentlemen, and welcome to the CytoSorbents Corporation third quarter 2025 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 13th, 2025. I w ...

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].

Accessibility StatementSkip Navigation PRINCETON, N.J., Oct. 28, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, honors the life and legacy of Dr. Robert Hawes Bartlett, MD (1939-2025), the company's former Chief Medical Officer from 2008-2017, who passed away last week at age 86. Dr. Robert Hawes Bartlett, MD - University of Michigan. Father of Extracorporeal Memb ...

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].

Summary of CytoSorbents Conference Call Company Overview - **Company**: CytoSorbents Corporation - **Industry**: Medical Devices, specifically blood purification technology - **Key Products**: - **CytoSorb**: A blood purification device for critical care and cardiac surgery - **DrugSorb-ATR**: An investigational device aimed at reducing perioperative bleeding during CABG surgery Core Points and Arguments - **CytoSorb Product Performance**: - Achieved record sales of **$36.1 million** in the trailing 12 months with **71% gross margins** [6] - CE-marked with nearly **300,000 uses** in over **70 countries** [6] - **DrugSorb-ATR Development**: - Targets a **$300 million** market opportunity, potentially growing to over **$1 billion** [6] - Received two **FDA Breakthrough Device designations** and is in discussions with FDA and Health Canada for marketing approval [6] - **Technology Description**: - Utilizes a **hemocompatible, highly porous polymer bead** for toxin removal, functioning similarly to the liver [7] - Offers a **three-year shelf life** at room temperature and is **gamma sterilizable** [7] - **Market Need**: - Addresses severe inflammation in critical illnesses, impacting **up to 60%** of ICU patients [10] - Sepsis is a leading indication, affecting **49 million** people globally and causing **11 million deaths** annually [13] - **Clinical Efficacy**: - Demonstrated significant improvements in critical illness metrics, including blood pressure and lung function [17] - A meta-analysis showed reduced in-hospital mortality and improved hemodynamic outcomes with CytoSorb treatment [18] - **Regulatory Challenges**: - Received a denial letter from FDA regarding DrugSorb-ATR but is in constructive discussions for a path forward [27] - Health Canada also issued a notice of refusal, citing missed primary endpoints in the broader population but success in CABG patients [28] Financial Performance - **Revenue Growth**: - Reported **$9.6 million** in revenue for Q2, a **9% increase** year-over-year, with **22% growth** in Germany [29] - Maintained **71% gross margins**, consistent with previous periods [30] - **Cash Position**: - Ended Q2 with **$11.7 million** in cash and equivalents, alongside **$15 million** in debt [30] - **Strategic Goals**: - Aiming for near cash flow break-even by the end of 2025 while preparing for DrugSorb-ATR market entry [31] Additional Insights - **Market Positioning**: - CytoSorb is positioned to address a larger patient population in the ICU compared to dialysis, creating a multi-billion dollar market opportunity [11] - **Clinical Registries**: - The **COSMOS Registry** collects real-world data to support the efficacy of CytoSorb in critical care settings [15] - **Future Outlook**: - The company remains committed to driving revenue growth and achieving regulatory approvals for DrugSorb-ATR, emphasizing the importance of treating the right patients at the right time [33]

Company Overview - CytoSorbents Corporation is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [3] - The company's proprietary technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids [3] - CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries, with nearly 300,000 devices used cumulatively [4] Product Applications - Key applications of CytoSorbents' technologies include the removal of blood thinners during cardiothoracic surgery and the removal of inflammatory agents in critical illnesses such as sepsis and trauma [3] - CytoSorb has received FDA Emergency Use Authorization for use in critically ill COVID-19 patients with respiratory failure [4] Regulatory Developments - The company is seeking FDA and Health Canada marketing authorization for the DrugSorb™-ATR antithrombotic removal system, which has received two FDA Breakthrough Device Designations [5] - In April 2025, the FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, citing deficiencies that need to be addressed [5] - The company is currently evaluating options for appeal with the FDA and has filed a Request for Reconsideration with Health Canada following a Notice of Refusal for its Medical Device License application [7][8] Upcoming Events - Management will present and participate in one-on-one meetings with investors at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [1][2]

Core Viewpoint - The FDA upheld the De Novo denial for CytoSorbents' DrugSorb-ATR device but found no safety issues, proposing a potential path forward for market authorization [2][3]. Regulatory Status - On August 14, 2025, the FDA issued a decision following an appeal regarding the De Novo application for DrugSorb-ATR, which was initially denied on April 25, 2025, due to the need for additional information [2][7]. - The FDA's appeal decision confirmed the device's safety but maintained the denial, indicating that further information is required to support the desired label indication [2][3]. - The FDA suggested a potential path forward for market authorization and noted that the company could appeal to a higher level within the FDA [2][7]. Company Insights - CytoSorbents Corporation specializes in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery [4][5]. - The company’s lead product, CytoSorb®, is already approved in the EU and has been used in nearly 300,000 devices globally [5]. - DrugSorb-ATR is designed to reduce perioperative bleeding in high-risk surgeries for patients on blood thinners, having received two FDA Breakthrough Device Designations [7][9]. Market Need - There is a significant need for solutions addressing perioperative bleeding in patients undergoing urgent coronary artery bypass graft (CABG) surgery, particularly those on ticagrelor [3][4]. - The technology aims to mitigate risks associated with blood thinners, which are increasingly common among patients, thereby addressing a critical issue faced by surgeons and patients alike [3][4].