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]

Financial Performance - Q1 2025 product sales were $8.7 million, a 3% year-over-year decrease, but flat on a constant currency basis[18] - Product gross margin was 71% in Q1 2025, consistent with the average from 2024[18] - Total operating expenses decreased by 12% year-over-year, from $11.5 million to $10.1 million[50] - Net loss improved by 17% year-over-year, from $6.1 million ($0.11/share) to $1.5 million ($0.02/share)[50] DrugSorb-ATR Regulatory Update - The company submitted a De Novo submission to the FDA and a Medical Device License application to Health Canada, but received a denial letter from the FDA on April 25, 2025[36] - The company plans to file a formal appeal within 60 days of the FDA letter[36] - Health Canada submission is in advanced review, with a decision expected in 2025[36] DrugSorb-ATR Market Opportunity - DrugSorb-ATR addresses a $300+ million initial market opportunity, which could exceed $1 billion as Brilinta becomes generic and DrugSorb-ATR expands to additional indications[33] CytoSorb Core Business - Core product sales reached a record $35.6 million in 2024[14] - The company aims to return Germany to growth in the second half of 2025 after flat sales for two consecutive years[18] - The company is managing its total core business toward near breakeven in the second half of 2025[18] Balance Sheet - The company received $6.8 million from a successful Rights Offering[51] - The company released $5.0 million of restricted cash[51] - The company had $13.1 million in cash, cash equivalents, and restricted cash at March 31, 2025[51]

Summary of CytoSorbents Conference Call Company Overview - **Company**: CytoSorbents - **Industry**: Medical Supplies and Devices - **Key Products**: - **CytoSorb**: Blood purification technology for critical care and cardiac surgery - **DrugSorb ATR**: Investigational product for reducing perioperative bleeding during CABG surgery Core Points and Arguments 1. **CytoSorb Product Performance**: - Achieved record core non-COVID product sales of $35.6 million in 2024, growing 15% year-over-year [3] - Over 270,000 human treatments in more than 70 countries [3] - High gross margins of 71% [27] 2. **DrugSorb ATR Development**: - Designed to address bleeding complications in patients on blood thinners during surgery [11] - Received two FDA breakthrough device designations [14] - Aimed at a significant unmet medical need in the US and Canadian markets [3] 3. **Technology and Mechanism**: - Utilizes a patented polymer bead technology that effectively removes a broad range of harmful substances from blood [4] - CytoSorb targets severe inflammation, which affects up to 60% of ICU patients [7] 4. **Clinical Research and Efficacy**: - Recent studies show significant reductions in mortality and shock reversal in patients treated with CytoSorb [8][10] - Meta-analysis indicated a 50% reduction in 28-day all-cause mortality in patients treated with CytoSorb [10] 5. **Regulatory Updates**: - FDA denial letter received on April 25, 2025, but the company plans to file a formal appeal [23][24] - Health Canada submission is under advanced review, with expectations for decisions in 2023 [25] 6. **Market Potential**: - Total addressable market estimated at $300 million initially, potentially growing to over $1 billion with additional indications [26] 7. **Financial Position**: - Cash position of $13.1 million at the end of Q1, with a quarterly burn rate of $2.5 million to $3 million [46] - Aiming for cash flow breakeven by the second half of 2025 [28] 8. **Sales Strategy**: - Plans for a controlled market release in clinical trial centers post-approval, followed by a broader launch in 2026 [36] - Predominantly direct sales force in the US, complemented by perfusionist distributors [37] 9. **Challenges in Germany**: - Germany accounts for about 40% of revenue but has seen flat growth due to macroeconomic factors [52] - Organizational changes are being made to drive deeper into accounts and improve sales effectiveness [53] Additional Important Information - **Cost Savings for Hospitals**: - Using DrugSorb can save hospitals $18,000 to $30,000 per patient by reducing the need for prolonged ICU stays to wash out blood thinners [43] - **Clinical Trial Insights**: - The STAR T trial showed that DrugSorb ATR significantly reduced bleeding severity in CABG patients [19] - **Market Preparation**: - The company is actively preparing for market entry while awaiting regulatory decisions [31] This summary encapsulates the key points discussed during the conference call, highlighting the company's product performance, regulatory challenges, market potential, and strategic direction.

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $8,700,000, a 3% decrease compared to $9,000,000 in Q1 2024, but flat on a constant currency basis [31][32] - Gross margin for the quarter was 71%, consistent with the full year 2024, but lower than 76% in Q1 2024 due to a 23% reduction in units produced [32] - Operating loss improved by 17% to $3,900,000 compared to $4,700,000 in 2024, driven by a 12% reduction in operating expenses [32][33] - Net loss for the quarter was $1,500,000 or $0.02 per share, compared to $6,100,000 or $0.11 per share in the prior year [33] Business Line Data and Key Metrics Changes - Core product sales for CytoSorb in Q1 2025 were $8,700,000, representing a 3% year-over-year decline, but constant currency sales were approximately the same as the previous year [9][10] - International distribution and other direct sales markets showed strong performance, offsetting temporary disruptions in the German direct sales segment [10] Market Data and Key Metrics Changes - Germany accounts for approximately 40% of the company's sales, and efforts are underway to return to growth in this critical market after two years of flat performance [16] - The company is focusing on expanding its presence in Dubai to access high-growth markets in the Middle East and Africa [17] Company Strategy and Development Direction - The company aims to achieve near breakeven by the end of 2025 while preparing for the anticipated launch of DrugSorb ATR in the U.S. and Canada [35][39] - Key growth catalysts include publicizing new clinical data, simplifying customer messaging, and returning German sales to growth [14][16] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their submission for DrugSorb ATR and the potential for a positive outcome from the FDA appeal process [46][47] - The company is actively preparing for the potential commercial launch of DrugSorb ATR, emphasizing the importance of real-world data and clinical evidence [27][39] Other Important Information - The company raised $6,800,000 through a shareholder rights offering, which increased available liquidity and allowed for the release of $5,000,000 of restricted cash [33][34] - The company welcomed a new Vice President of Marketing for North America to lead the strategy for DrugSorb ATR [29][30] Q&A Session Summary Question: Can you talk about your level of confidence in getting clearance for DrugSorb ATR? - Management expressed strong confidence in the strength of their submission and the compelling data from the STAR T trial, believing the chances during the appeal process are good [46][47] Question: What happens if the appeal is denied? - Management indicated that if the appeal is unsuccessful, they could continue with a new de novo submission using a large portion of the original submission, which would result in a shorter review time [47][48] Question: Will the clinical data help with marketing or reimbursement in Europe? - Management confirmed that strong clinical data is crucial for supporting reimbursement and health technology assessment decisions in the EU [51] Question: Are there any updates on other products in development besides CytoSorb and DrugSorb ATR? - Management stated that the primary focus is currently on DrugSorb ATR, with other technologies like HemoDefend VGA being discussed for the future [60] Question: What is the visibility into the conditions in Germany for growth? - Management acknowledged the unique challenges in Germany but expressed optimism about the changes being implemented to drive operational efficiency and expected benefits in the second half of the year [66]