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]

Financial Performance - Total revenue for Q3 2023 was $881 million, an increase of approximately 86% compared to $811 million for Q3 2022[27] - Product sales for Q3 2023 were approximately $775 million, a 20% increase compared to $646 million in Q3 2022[27] - Product gross margins for Q3 2023 were 72%, compared to 55% for Q3 2022[27] - Total YTD revenue as of September 30, 2023, was $2768 million, a 94% increase compared to $2530 million for the same period in 2022[28] - YTD product sales as of September 30, 2023, were approximately $2374 million, a 93% increase over $2172 million for the same period a year ago[28] Operational Highlights & DrugSorb-ATR - The STAR-T RCT completed in August, with follow-up on 100% of patients, at 30 centers in the US and Canada[12] - The company expects DrugSorb-ATR to have a higher ASP and product gross margin than CytoSorb and would open an expected US and Canadian TAM of $600-650 million for Brilinta alone[40] - Over 221000 cumulative human treatments delivered across 75 countries worldwide[7] Cash Flow - Cash balance as of 9/30/2023 was approximately $10 million, which included restricted cash of approximately $17 million[33] - The quarterly cash burn during the nine months in 2023 averaged approximately $46 million, down significantly from the average quarterly cash burn in the nine months of 2022 of approximately $99 million[33] Strategic Partnership - Fresenius has begun marketing CytoSorb as the "featured technology for cytokine, bilirubin, and myoglobin removal" on its critical care platforms worldwide (excluding the US)[23] - CytoSorbents benefits from the global endorsement and push on Fresenius' sales and marketing platform and has agreed to subsidize this effort with a 09% royalty to FMC on ex-US CytoSorb sales[23]

Financial Performance - Q1 2024 product sales reached approximately $9.0 million, a 14% increase from $7.9 million in Q1 2023[12, 20] - Q1 2024 product sales increased 22% sequentially from $7.3 million in Q4 2023[12] - Product gross margins for Q1 2024 were 76%, up 800 basis points from 68% in Q1 2023, excluding a one-time inventory adjustment[12, 20] - Grant revenue was $797,000 in Q1 2024, compared to $1.5 million in Q1 2023, a decrease of 48%[20] - Total revenue for Q1 2024, including product sales and grant income, was $9.8 million, compared to $9.4 million for Q1 2023, a 4% increase[20] Operational Highlights - Cumulative CytoSorb treatments exceeded 237,000 as of March 31, 2024, and are expected to reach a quarter million this year[15] - The company expects to launch the PuriFi hemoperfusion pump in select international countries in Q2 2024[15] - The company is on track to submit marketing applications for the DrugSorb-ATR system to the FDA and Health Canada in Q3 2024[12] DrugSorb-ATR and Regulatory Path - The FDA has granted two Breakthrough Device Designations for DrugSorb-ATR[30] - Regulatory experts recommend FDA submission for DrugSorb-ATR use in CABG surgery under the De Novo pathway[40] - The company is targeting parallel De Novo submission to FDA and Health Canada in Q3 2024, with FDA review potentially taking 6-12 months following submission[39, 40] STAR-T Trial - In the Isolated CABG Per Protocol group, the Severe endpoint showed a WIN Ratio of 1.59 with a p-value of 0.041[32] - Exploratory analysis of Major Bleeding showed a reduction from 22% in the control group to 6% in the DrugSorb group, with p=0.028[34]

Financial Performance - Total revenue in Q2 2024 increased by 5% to $9.9 million compared to $9.4 million in Q2 2023[10, 20] - Product sales in Q2 2024 increased by 10% to $8.8 million compared to $8.1 million in Q2 2023[10, 20] - Operating loss in Q2 2024 decreased by 48% to $3.4 million from $6.6 million[10] - For the first half of 2024, total revenue increased by 4% to $19.7 million compared to $18.9 million in the first half of 2023[21] - Product sales for the first half of 2024 increased by 12% to approximately $17.8 million compared to $16.0 million in the same period last year[21] - The company's cash balance at the end of Q2 2024 was $14.9 million, including $8.5 million in unrestricted cash and $6.5 million in restricted cash[10] Operational Highlights - Over a quarter million CytoSorb devices have been cumulatively delivered to date[10] - The company completed additional cutbacks, expected to save an additional $5 million in expenses going forward, and decreased the workforce by 17% over the past 5 months[10] - The company secured an additional $20 million credit facility with Avenue Capital Group[10] Regulatory and Clinical Developments - The company is on track to submit marketing applications for the investigational DrugSorb-ATR system to FDA as a De Novo application and Health Canada in Q3 2024[15] - Data from the STAR Registry was presented at EuroPCR 2024 and was selected as a top 5 finalist in the best scientific abstract competition[15] - Real-world data from the STAR Registry showed a 44% lower rate of severe bleeding (UDPB 3) with CytoSorb compared with the E-CABG Registry when TLD is less than 24 hours, and an 80% lower rate when TLD is between 24-72 hours[37]

Financial Performance - CytoSorbents' product revenue in Q3 2024 reached $8.6 million, showing an 11% year-over-year growth[16] - The company's operating expenses decreased by 25% year-over-year in Q3 2024[16,51] - The operating loss was reduced by 40% year-over-year[16,51] - Cash burn was reduced to $2.7 million in Q3 2024, down from $5 million in Q2 2024[16,54] - As of September 30, 2024, the company had $12.2 million in cash, including $6.5 million of restricted cash and $5.7 million in unrestricted cash[57] DrugSorb-ATR Regulatory and Clinical Updates - DrugSorb-ATR, an investigational device, has been submitted to the FDA and Health Canada, with regulatory decisions expected in 2025[12,21] - The company submitted a De Novo medical device marketing application to the FDA on September 27, 2024, which was accepted in October 2024[22] - In isolated CABG patients, the intraoperative use of DrugSorb-ATR was associated with reduced bleeding severity[20] - Real-world evidence from an additional 102 CABG patients on Brilinta suggests that the guideline-recommended washout period of a minimum of 72 hours may be substantially shortened with CytoSorb and DrugSorb-ATR[23] Market Opportunity - The company estimates an initial market opportunity of over $300 million for Ticagrelor removal in CABG in the U S and Canada[31]