Financial Data and Key Metrics Changes - Full year 2025 sales revenues increased by 4% to $37.1 million, representing record core product sales [5][15] - Gross margins reached 71% for the full year and improved to 74% in Q4 2025, driven by manufacturing efficiencies [7][17] - Operating loss for 2025 improved by 10% to $14.7 million compared to $16.5 million in 2024 [16] - Adjusted net loss for 2025 was $14.2 million or $0.23 per share, compared to an adjusted net loss of $12.7 million or $0.23 per share in 2024 [17] Business Line Data and Key Metrics Changes - Direct sales outside of Germany increased by 13% to $8.6 million, while distributor sales grew by 11.4% to $16.5 million, together accounting for approximately 68% of total revenue [6][15] - Sales in Germany declined by 10% to $11.8 million, reflecting the near-term impact of restructuring efforts [6][15] Market Data and Key Metrics Changes - The company has delivered over 300,000 treatments globally across 70 countries, indicating a broad and growing clinical footprint [4] - Clinical evidence continues to drive adoption, with over 75% of surveyed physicians adopting blood purification, with CytoSorb being one of the most commonly used modalities [10] Company Strategy and Development Direction - The company is focused on driving sales growth outside of Germany while repositioning its operations in Germany for long-term success [5] - The PuriFi initiative aims to expand access and utilization of CytoSorb therapy without reliance on existing dialysis infrastructure [8] - DrugSorb-ATR represents a significant pipeline opportunity, with an estimated initial market opportunity of over $300 million, expanding to over $1 billion over time [12] Management's Comments on Operating Environment and Future Outlook - Management believes that the actions taken in 2025 have positioned the company well heading into 2026, with expectations for gradual and sustained improvement in Germany [5][21] - The company aims to achieve cash flow break-even in the second half of 2026, supported by operational improvements and cost structure adjustments [21][22] Other Important Information - The company has strengthened its balance sheet and lowered its cost structure, establishing a realistic path to cash flow breakeven in 2026 [23] - The STAR-T randomized controlled trial has been published, showing that DrugSorb-ATR was safe and reduces the severity of bleeding in high-risk CABG patients [13] Q&A Session Summary Question: FDA regulatory process and timelines - Management is in interactive discussions with the FDA to ensure alignment before submission, aiming to streamline the process [27][29] Question: Confidence in reaching consensus with the FDA - Management is cautiously optimistic about aligning with the FDA and is working to define additional details to avoid surprises [28][29] Question: Early signs of improvement in the German market - Management noted leadership changes and a proactive approach to market development, which are expected to yield predictable sales momentum [30][31] Question: Status of the restructuring in Germany - Management believes they are in the later innings of restructuring, with incremental improvements expected over time [38] Question: Gross margin expectations for 2026 - Management aims to maintain gross margins in the low 70% range, with potential for improvement depending on increased volumes [40] Question: PuriFi pump strategy and revenue model - The PuriFi pump is viewed as an investment strategy, similar to a printer cartridge model, with expectations for future disposable revenue growth [41][42] Question: Pathway to breakeven and necessary steps - Management highlighted cost reduction initiatives and improved production efficiencies as key factors in reaching breakeven [46][47] Question: De-risking steps for DrugSorb-ATR resubmission - Management is ensuring alignment with the FDA to avoid another denial and is taking a cautious approach to the submission process [48][49]

Financial Data and Key Metrics Changes - Full year 2025 sales revenues increased by 4% to $37.1 million, representing record core product sales [5][15] - Gross margins reached 71% for the full year and improved to 74% in Q4 2025, driven by manufacturing efficiencies [7][17] - Operating loss for 2025 improved by 10% to $14.7 million compared to $16.5 million in 2024 [16] - Adjusted net loss for 2025 was $14.2 million or $0.23 per share, compared to an adjusted net loss of $12.7 million or $0.23 per share in 2024 [19] Business Line Data and Key Metrics Changes - Direct sales outside of Germany increased by 13% to $8.6 million, while distributor sales grew by 11.4% to $16.5 million, together accounting for approximately 68% of total revenue [6][15] - Sales in Germany declined by 10% to $11.8 million, reflecting the near-term impact of restructuring efforts [6][15] Market Data and Key Metrics Changes - The company has delivered over 300,000 treatments globally across 70 countries, indicating a broad and growing clinical footprint [4] - Clinical evidence continues to drive adoption, with over 75% of surveyed physicians adopting blood purification, with CytoSorb being one of the most commonly used modalities [10] Company Strategy and Development Direction - The company is focused on driving sales growth outside of Germany while repositioning the German market for long-term success [5] - Key priorities include advancing DrugSorb-ATR through the FDA regulatory process and achieving cash flow break-even by the second half of 2026 [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about early signs of improvement in the German market and expects gradual and sustained improvement throughout 2026 [8][31] - The company aims to create meaningful long-term value through consistent revenue growth and a strong focus on clinical evidence [23] Other Important Information - The PuriFi pump is a strategic initiative aimed at expanding access and utilization, with over 100 units placed globally [8] - The company is working on a streamlined and targeted resubmission for DrugSorb-ATR following a previous denial, with no safety concerns raised by the FDA [12][48] Q&A Session Summary Question: FDA regulatory process and timelines - Management is in interactive discussions with the FDA to ensure alignment before submission, aiming to streamline the process [27][29] Question: Confidence in reaching consensus with the FDA - Management believes they are on a defined regulatory path and is working to ensure no surprises during the submission process [28][29] Question: Early signs of improvement in the German market - Management noted a leadership change and a proactive approach to market development, leading to increased engagement and pipeline activity [31] Question: Status of the restructuring in Germany - Management believes they are in the later innings of restructuring, with expectations for incremental improvement over time [38] Question: Future gross margin expectations - Management aims to maintain gross margins above 71% and is optimistic about potential improvements with increased volumes [40] Question: PuriFi pump revenue model - The PuriFi pump is seen as an investment strategy, similar to a printer cartridge model, with expectations for future disposable revenue growth [41][42] Question: Pathway to operating break-even - Management is implementing cost reduction initiatives and expects to achieve cash flow break-even in the second half of 2026 [46][47] Question: De-risking steps for DrugSorb-ATR resubmission - Management is ensuring alignment with the FDA to avoid surprises and is taking a cautious approach to the resubmission process [48][49]

Company Overview - CytoSorbents has made significant progress with two key products: CytoSorb, which removes harmful cytokines from the blood, and DrugSorb, which is designed to eliminate drugs, particularly blood thinners [2]. Industry Context - The biotechnology sector, particularly microcap companies like CytoSorbents, faces challenges due to the evolving regulatory landscape and the nascent nature of the science and technology involved [3]. Future Outlook - The company is preparing for key upcoming events that are crucial for investors to monitor, indicating a proactive approach to navigating the complexities of the biotechnology industry [3].

Summary of CytoSorbents Fireside Chat - December 15, 2025 Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Biotechnology, specifically medical devices focused on blood purification - **Key Products**: - **CytoSorb**: Removes cytokines and toxic substances from blood - **DrugSorb-ATR**: Investigational product aimed at removing blood thinners Core Points and Arguments - **Product Mechanism**: CytoSorb utilizes a highly porous polymer bead technology to extract toxic materials from blood without the need for affinity agents, making it compatible with existing hospital blood pumps [6][7] - **Market Presence**: CytoSorb is EU-approved and sold in over 70 countries, with more than 300,000 human treatments conducted to date, generating approximately $37 million in trailing 12-month revenue [9][10] - **Gross Margins**: The product has a gross margin of about 71%, with potential for higher margins as the U.S. market is pursued [10] - **Regulatory Strategy**: The company is focusing on the U.S. market for DrugSorb, which has received two FDA breakthrough device designations due to the significant unmet medical need for managing perioperative bleeding in patients on blood thinners [11][22] - **Clinical Trials**: The START trial, a randomized controlled trial involving 140 patients, aimed to demonstrate the efficacy of DrugSorb in reducing perioperative bleeding but missed its primary endpoint due to trial design issues [41][51] - **Regulatory Discussions**: The FDA has acknowledged the safety of the device and is open to a new De Novo submission that includes real-world evidence to support efficacy [58][62] Financial Management - **Cash Flow Strategy**: The company aims to achieve cash flow break-even by early 2026, with a refinancing agreement providing additional cash and extending the interest-only period on debt [70][71] - **Market Opportunity**: The total addressable market for DrugSorb is estimated at $300 million, potentially growing to over $1 billion as additional blood thinners and surgeries are included [26] Pipeline and Future Prospects - **Product Pipeline**: In addition to CytoSorb and DrugSorb, the company has products like VetRescue for animals and HemoDefend-BGA for universal plasma, indicating a broadening of its product offerings [12][13] - **Launch Strategy**: Upon FDA approval, the company plans a targeted launch in the U.S., focusing on clinical sites that have shown interest in the product [73][74] - **Regulatory Outlook**: The company expects to submit a new De Novo application in early 2026, with the potential for approval within the same year [64][65] Additional Insights - **Market Challenges**: The company faces challenges typical of microcap biotech firms, including the need for substantial resources for clinical trials and regulatory approvals [51][52] - **Surgeon Interest**: There is significant interest from surgeons in the U.S. for a solution to manage bleeding risks associated with blood thinners during surgeries, which could facilitate a successful product launch [74] This summary encapsulates the key points discussed during the fireside chat, highlighting the company's current status, regulatory strategies, financial management, and future prospects in the biotechnology industry.

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]

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]

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].

Financial Data and Key Metrics Changes - In Q2 2025, the company reported product sales of $9.6 million, representing a 9% year-over-year increase and a 4% increase on a constant currency basis compared to the same period last year [8][28] - Gross margin performance remained solid at approximately 71% [9][29] - The operating loss for Q2 was approximately $3.6 million, flat year-over-year, with a net income of $1.9 million compared to a net loss of $4.3 million in the prior year [30][31] Business Line Data and Key Metrics Changes - The German commercial team saw a 22% year-over-year growth, contributing to overall positive performance [8][28] - Distributor sales were among the best ever, second only to a record second quarter last year [9][28] Market Data and Key Metrics Changes - CytoSorb, the flagship product, has been utilized in nearly 300,000 devices across more than 70 countries, driving significant sales [6] - The company is navigating the regulatory process for DrugSorb ATR, with final decisions expected this year [6][18] Company Strategy and Development Direction - The company aims to drive its core business towards near breakeven by the end of 2025 while preparing for the North American commercial launch of DrugSorb ATR [8][32] - The strategic realignment of the German commercial team is expected to lead to stronger execution and improved performance [9][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the appeals process for DrugSorb ATR, highlighting the strengths of their application and external expert support [39][40] - The company remains optimistic about final regulatory decisions from both the FDA and Health Canada, expected before the end of 2025 [17][18] Other Important Information - The company is actively preparing for a potential North American commercial launch of DrugSorb ATR later this year and into 2026 [32][34] - September is designated as Sepsis Awareness Month, with the company participating in initiatives to highlight the treatment of sepsis and septic shock [21][22] Q&A Session Summary Question: Can you provide more confidence regarding the regulatory submissions? - Management highlighted the positive aspects of the appeals process and the support from external cardiac surgery experts, expressing hope for a favorable FDA response soon [39] Question: Update on Germany's performance and organizational changes? - Management noted a 22% increase in the second quarter and emphasized that the reorganization is a work in progress aimed at improving efficiency [41][43] Question: Clarification on the reconsideration request in Canada? - The company clarified that the request for reconsideration is part of a formal appeals process similar to that with the FDA [48] Question: What is the rollout strategy for DrugSorb ATR in the U.S.? - The rollout will be purposeful, focusing on clinical accounts that participated in the study and a few others, with an emphasis on understanding the pace of adoption [50] Question: How does the sepsis and septic shock data affect the business model? - Management indicated that sepsis and septic shock are core applications for CytoSorb, accounting for a significant portion of critical care revenue, and emphasized the need for effective treatment strategies [51][52] Question: Expectations for gross margins in Q3 and Q4? - Management expressed that while gross margins have been stable, there are opportunities to improve efficiencies and potentially increase margins with the approval of DrugSorb ATR [55]

Core Viewpoint - CytoSorbents Corporation is actively pursuing regulatory approvals for its DrugSorb™-ATR device, aimed at reducing perioperative bleeding in patients undergoing CABG surgery who are on the antiplatelet drug Brilinta® [1][4] Regulatory Updates - The FDA has scheduled an appeal hearing for CytoSorbents' supervisory review of its De Novo Request, with expectations to resolve deficiencies by the end of August 2025 [2] - Health Canada issued a Notice of Refusal for the Medical Device License application, prompting the company to file a Request for Reconsideration by July 25, 2025 [3] Product Overview - DrugSorb-ATR is designed to address a significant need in cardiac surgery by mitigating bleeding risks associated with Brilinta® [4] - The device has received FDA Breakthrough Device Designation for removing ticagrelor and other direct oral anticoagulants during cardiothoracic procedures [8] Company Background - CytoSorbents specializes in blood purification therapies for critical conditions, utilizing proprietary polymer bead technology to remove toxins from blood [5] - The company's lead product, CytoSorb®, is already approved in the EU and has been used over 270,000 times globally [6]

Company Overview - CytoSorbents has a platform blood purification technology for removing toxins, with two main products: CytoSorb and DrugSorb-ATR[8] - CytoSorb is approved in the E U with over 250,000 devices used in 76 countries, generating approximately $34 million in trailing 12-month product sales[8] - DrugSorb-ATR, an investigational device for removing blood thinners, has been submitted to the FDA and Health Canada, with regulatory decisions expected in 2025[8] DrugSorb-ATR Opportunity - The initial U S and Canada total addressable market for Brilinta removal is estimated at ~$300 million[67] - The total addressable market potential for DrugSorb-ATR, including DOAC removal, is >$600 million in the U S and Canada[67] - In patients undergoing CABG, DrugSorb-ATR was associated with a Number Needed to Treat (NNT) of 6 to prevent a major bleed (UDPB 3 event or CTD >1 Liter)[56] CytoSorb Core Business - CytoSorb targets massive inflammation, which affects 40-60% of patients in the ICU[79] - The company's manufacturing facility has a peak capacity of $400 million in sales, with blended product gross margins >70%[83] Financial Performance - The company reported $33.7 million in trailing 12-month sales[88] - Q1-Q3 product sales reached $26.4 million, an 11% year-over-year increase[88] - The company's cash burn was reduced to approximately $2.7 million in Q3 2024, compared to $5 million in Q2 2024[90]