Financial Data and Key Metrics Changes - Product revenue for Q4 2024 was $9.2 million, a 25% increase from $7.3 million in Q4 2023, and total product revenue for the full year reached $35.6 million, representing a 15% year-over-year growth [11][39][47] - Gross margin for Q4 2024 improved to 71%, up from 68% in Q4 2023, reflecting a return to normalized production levels [42][50] - Operating loss for 2024 improved by 47% to $16.7 million compared to $31.9 million in 2023, driven by higher revenue and reduced operating expenses [50] Business Line Data and Key Metrics Changes - CytoSorb, the flagship product, generated $35.6 million in core product sales in 2024, with a 15% growth driven by 28% growth in direct sales outside Germany and 22% growth in distributor and partner sales [9][11] - DrugSorb-ATR is in the regulatory process, with marketing applications submitted to the FDA and Health Canada, expected to drive near-term growth opportunities [10][31] Market Data and Key Metrics Changes - The international market for CytoSorb has shown strong growth, particularly in countries that have secured reimbursement for specific applications, while the German market has faced challenges due to post-COVID issues [11][77] - The total addressable market for DrugSorb-ATR in the U.S. and Canada is projected to grow from $300 million today to over $1 billion as Brilinta becomes generic [30][31] Company Strategy and Development Direction - The company aims to restore sales growth in Germany through a reorganization of the direct sales team and strategy, focusing on deeper customer engagement and improved sales representative productivity [24][52] - The strategy includes a controlled market release of DrugSorb-ATR to gather real-world feedback before a broader launch [32][57] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving near cash flow breakeven by the end of 2025 through revenue growth and cost management [15][45] - The company is optimistic about the potential for DrugSorb-ATR to significantly impact revenue and market presence once regulatory approvals are obtained [31][57] Other Important Information - The company identified misstatements in inventory and stock compensation, leading to restatements of previous financial statements [37][38] - Total cash and cash equivalents as of December 31, 2024, were $9.8 million, with a pro forma cash position of approximately $17 million after the rights offering [15][46] Q&A Session Summary Question: Impact of new U.S. administration on DrugSorb regulatory process - Management indicated that while there has been uncertainty regarding FDA staffing, it has not affected review personnel [61] Question: Key factors for controlled launch of DrugSorb - Management highlighted the importance of understanding hospital integration and surgeon usage patterns during the controlled launch [63][64] Question: Growth drivers for CytoSorb sales outside Germany - Management noted strong growth in international markets due to reimbursement success and increased physician adoption [74][75] Question: Metrics for achieving near cash breakeven - Management stated that continued revenue growth and maintaining gross margins above 70% are essential for reaching breakeven [85] Question: Clarification on DrugSorb revenue assumptions - Management confirmed that the breakeven target excludes DrugSorb revenues, focusing solely on core business performance [89] Question: FDA's potential requests during the review process - Management confirmed ongoing interactive discussions with the FDA, indicating a collaborative review process [96]

Financial Data and Key Metrics Changes - Product revenue for Q4 2024 was $9.2 million, a 25% increase from $7.3 million in Q4 2023, and total product revenue for the full year reached $35.6 million, representing a 15% year-over-year growth [11][39][47] - Gross margin for Q4 2024 improved to 71%, up from 68% in Q4 2023, reflecting a return to normalized production levels [42][50] - Operating loss for 2024 improved by 47% to $16.7 million compared to $31.9 million in 2023, driven by higher revenue and reduced operating expenses [50] Business Line Data and Key Metrics Changes - CytoSorb, the flagship product, generated $35.6 million in core product sales in 2024, with a 15% growth driven by 28% growth in direct sales outside Germany and 22% growth in distributor and partner sales [9][11] - DrugSorb-ATR is in the regulatory process, with marketing applications submitted to the FDA and Health Canada, expected to drive near-term growth opportunities [10][31] Market Data and Key Metrics Changes - The total addressable market for DrugSorb-ATR in the U.S. and Canada is projected to grow from $300 million today to over $1 billion as Brilinta becomes generic [30][31] - International direct sales outside Germany showed strong growth, attributed to successful reimbursement and tender order payments in various countries [75] Company Strategy and Development Direction - The company aims to restore sales growth in Germany through a reorganization of the direct sales team and strategy, focusing on deeper customer engagement and improved sales representative productivity [24][51] - The strategy includes optimizing treatment strategies and improving clinical outcomes to drive greater usage and adoption of CytoSorb [55][56] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving near cash flow breakeven by the end of 2025 through disciplined execution of growth strategies and effective cost controls [15][45] - The company is optimistic about the potential for DrugSorb-ATR to significantly impact revenue and market presence upon regulatory approval [31][57] Other Important Information - The company identified misstatements in inventory and non-cash stock compensation, leading to restatements of previous financial statements [37][38] - As of December 31, 2024, total cash and cash equivalents were $9.8 million, with a pro forma cash position of approximately $17 million after the rights offering [15][46] Q&A Session Summary Question: Impact of new U.S. administration on DrugSorb regulatory process - Management noted that while there is uncertainty regarding HHS cuts, they do not target review personnel, maintaining confidence in receiving clearance by year-end [61] Question: Key metrics for controlled launch of DrugSorb - Management highlighted the importance of understanding hospital integration and surgeon usage patterns during the controlled launch phase [63] Question: Growth drivers for sales outside Germany - Management attributed growth to successful reimbursement and increased physician usage in international markets, contrasting with challenges in the German market [74][78] Question: Metrics needed to reach cash breakeven - Management indicated that continued revenue growth and maintaining gross margins above 70% are essential for approaching cash flow breakeven [85] Question: Clarification on DrugSorb revenues and core business - Management confirmed that discussions about breakeven exclude DrugSorb revenues, focusing solely on the core business [89] Question: FDA's potential requests during the review process - Management confirmed ongoing interactive discussions with the FDA, indicating a collaborative review process [96]

Financial Results Announcement - CytoSorbents Corporation announced preliminary and unaudited financial results for the quarter and year ended December 31, 2024[4] - The press release detailing the financial results and business updates was issued on January 3, 2025[4] Regulatory and Filing Information - The financial results are not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934[4] - The press release is furnished as Exhibit 99.1 in the Form 8-K filing[4] Executive Signatory - The report was signed by Dr. Phillip P. Chan, Chief Executive Officer of CytoSorbents Corporation[7]

Financial Performance - Total product revenue for the year ended December 31, 2024, was $35.6 million, an increase of $4.5 million, or 15%, compared to $31.1 million in 2023[252]. - Gross profit for the year ended December 31, 2024, was approximately $25.1 million, an increase of $3.2 million, or 14%, compared to $22.0 million in 2023[256]. - Loss from operations improved by 47% to approximately $16.8 million for the year ended December 31, 2024, down from $31.9 million in 2023, due to revenue growth and a 22% reduction in total operating expenses[260]. - The company experienced a loss on foreign currency transactions of approximately $4.2 million for the year ended December 31, 2024, compared to a gain of approximately $1.9 million in 2023[262]. - The company recorded approximately $3.76 million in stock-based compensation expense for the year ended December 31, 2024, including 1,214,400 performance awards granted[280]. Expenses Management - Research and development expenses decreased by approximately $8.7 million, or 56%, to $6.9 million for the year ended December 31, 2024, primarily due to the completion of the STAR-T clinical trial[257]. - Selling, general and administrative expenses decreased by approximately $3.3 million, or 9%, to $35.0 million for the year ended December 31, 2024, mainly due to reductions in salaries and professional expenses[259]. - The company continues to manage resources proactively, focusing on regulatory submissions and maintaining tight control over expenditures[268]. - The company has adjusted its accounting policy for grants, retroactively reclassifying grant income as a reduction of research and development expenses[279]. Financing Activities - The company secured a $20 million credit facility in June 2024, with an initial tranche of $15 million available at closing[266]. - The company raised a total of $7.3 million through the Rights Offering and Series A Right Warrants, increasing unrestricted cash to $15.6 million as of December 31, 2024, compared to $3.3 million previously reported[270]. - The Rights Offering closed on January 10, 2025, raising gross proceeds of $6.25 million from the sale of 6.25 million Units, each comprising one share of common stock and two Right Warrants[271]. - Approximately 1.4 million Series A Right Warrants were exercised at an exercise price of $1.13 per warrant, generating an additional $1.6 million in gross proceeds[271]. - The Avenue Capital Group has committed to loan the company up to $20 million, with $15 million available in the first tranche and a second tranche of up to $5 million contingent on FDA approval[273]. - The proceeds from the Avenue Capital Commitment will be used to pay off existing debt and for working capital, with interest rates set at a minimum of 5% above the Prime Rate or 13.5%[275]. - The company is actively pursuing various financing sources, including equity and debt financing, to meet its increasing capital needs[272]. Regulatory and Operational Updates - The company submitted a De Novo medical device application for DrugSorb-ATR to the FDA on September 27, 2024, which was accepted for substantive review in October 2024[250]. - The company expects to receive regulatory approval for DrugSorb-ATR in the U.S. and Canada in 2025, which is critical for future capital requirements[272]. - As of December 31, 2024, the company had current assets of approximately $21.6 million and current liabilities of approximately $9.9 million[264]. - The company operates leased facilities in Princeton, New Jersey, and Berlin, Germany, with a monthly base rent of approximately $121,000 as of December 31, 2024[283].

Core Viewpoint - CytoSorbents Corporation reported strong financial results for Q4 and full year 2024, highlighting significant growth in product sales and advancements in regulatory milestones, setting a positive outlook for 2025 [1][3][7]. Financial Performance - Q4 2024 product revenue reached $9.2 million, a 25% increase from $7.3 million in Q4 2023, with a product gross margin of 71% compared to 68% in the previous year [7]. - Full year 2024 product revenue was $35.6 million, reflecting a 15% year-over-year increase from $31.1 million in 2023 [7]. - The operating loss for 2024 improved by 47% to $16.8 million from $32 million in 2023, driven by higher revenue and a 22% reduction in operating expenses [7]. - The net loss for 2024 was $20.7 million, or $0.38 per share, compared to a net loss of $29.2 million, or $0.65 per share in 2023 [7]. Sales Growth and Market Strategy - The core business experienced a 15% growth in 2024, with over $35 million in high-margin CytoSorb sales, driven by 28% growth in direct sales outside Germany and 22% growth in Distributor/Partner sales [4][7]. - The company is focusing on restoring sales growth in Germany, which has been flat for two consecutive years, through a reorganization of the direct sales team and strategy [6][13]. Regulatory Developments - CytoSorbents anticipates regulatory decisions from Health Canada and the US FDA regarding DrugSorb-ATR in 2025, with significant strides made in bringing this therapy to market [7][19]. - The FDA accepted the De Novo application for DrugSorb-ATR, entering an interactive review phase, which is crucial for potential U.S. marketing approval [7][19]. Clinical Advancements - New clinical data presented at international conferences indicate that early and intensive treatment with CytoSorb significantly improves survival rates in patients with septic shock and multiorgan failure [5]. - The company is preparing for a controlled market release of DrugSorb-ATR at key clinical trial sites, pending regulatory approval, to gather real-world feedback and refine commercialization strategies [10][11]. Market Potential - The total addressable market for DrugSorb-ATR in the U.S. and Canada is projected to grow from $300 million to over $1 billion as the product establishes itself in the market [9].

Core Viewpoint - CytoSorbents Corporation reaffirms its preliminary financial results for Q4 and full year 2024, expecting regulatory decisions on DrugSorb™-ATR marketing applications in 2025 [1][4] Financial Results - The company plans to report Q4 and full year 2024 financial results and file its Form 10-K after market close on March 31, 2025 [2] - Estimated Q4 2024 product revenue is projected to be between $9.0 million and $9.2 million, reflecting a growth of 22% to 25% compared to $7.35 million in Q4 2023 [8] - Full-year product revenue is expected to be between $35.4 million and $35.6 million, indicating approximately 14% growth from $31.1 million in 2023 [8] - The estimated cash balance as of December 31, 2024, is approximately $17.0 million, including $15.5 million in unrestricted cash, after accounting for recent fundraising activities [5] DrugSorb-ATR Marketing Applications - The marketing applications for DrugSorb-ATR are under substantive review by the U.S. FDA and Health Canada, with decisions anticipated in 2025 [4][11] - DrugSorb-ATR is designed to reduce perioperative bleeding in high-risk surgeries and has received two FDA Breakthrough Device Designations [11] Conference Call Details - A live conference call and presentation will be held on March 31, 2025, at 4:30 PM ET, with details provided for participants to join [7]

Core Viewpoint - CytoSorbents Corporation reaffirms its preliminary financial results for the quarter and full year ended December 31, 2024, and anticipates regulatory decisions on DrugSorb™-ATR marketing applications in 2025 [1][6] Financial Results - The company expects to report fourth quarter and full year 2024 financial results after market close on March 25, 2025, with a live conference call scheduled for the same day [2] - Fourth quarter product revenue is projected to be between $9.0 million and $9.2 million, reflecting a growth of 22% to 25% compared to $7.35 million in the fourth quarter of 2023 [9] - Full-year product revenue is estimated to be between $35.4 million and $35.6 million, indicating approximately 14% growth from $31.1 million in 2023 [9] - The estimated cash balance as of December 31, 2024, is approximately $17.0 million, including unrestricted cash of about $15.5 million, following a net cash burn of approximately $2.5 million in Q4 2024 [7][8] Leadership and Transition - The postponement of the earnings call is due to the unexpected passing of the company's Vice President and Corporate Controller, James E. Cason, Jr., who had been with the company for 10 years [3][4] - The CEO expressed condolences and emphasized the strength of the financial team to ensure a smooth transition of responsibilities during this period [4] DrugSorb-ATR Development - The marketing applications for DrugSorb-ATR are under substantive review by the U.S. FDA and Health Canada, with regulatory decisions expected in 2025 [6][12] - DrugSorb-ATR is designed to reduce perioperative bleeding in high-risk surgeries and has received two FDA Breakthrough Device Designations [12]

Core Viewpoint - CytoSorbents Corporation will report its fourth quarter and full year 2024 financial results on March 6, 2025, highlighting its advancements in blood purification technologies for critical care [1][2]. Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [4]. - The company's proprietary technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood and bodily fluids [4]. - CytoSorbents' lead product, CytoSorb, is approved in the European Union and distributed in 76 countries, with over 250,000 devices used to date [5]. Product Development - The company is developing the DrugSorb™-ATR antithrombotic removal system to mitigate perioperative bleeding in high-risk surgeries [6]. - DrugSorb-ATR has received two FDA Breakthrough Device Designations for removing specific blood thinners during urgent cardiothoracic procedures [6]. - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR, which is currently under substantive review [6]. Market Presence - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients, although it is not yet approved in the U.S. [5]. - The company holds numerous patents and trademarks for its blood purification technologies, with several products under development [7].

Core Points - CytoSorbents Corporation raised $1.6 million from the exercise of 1,417,208 Series A Right Warrants at $1.13 per warrant, which expired on February 24, 2025 [1] - The total gross proceeds raised by the company now amount to $7.85 million, including $6.25 million from a previous Rights Offering on January 10, 2025 [2] - The proceeds from the Rights Offering have strengthened the company's balance sheet, increasing net liquidity to approximately $12.3 million after related fees [2] Financial Details - The exercise price of $1.13 per share was based on 90% of the 5-day volume weighted average price of the stock prior to the expiration date, which was $1.2589 per share [3] - Approximately 4.8 million shares of common stock remain available for the exercise of Series B Right Warrants, which will expire worthless if not exercised [4][6] Product Development - The company is pursuing U.S. and Canadian approval for its DrugSorb™-ATR product, with regulatory decisions expected in 2025 [3] - CytoSorbents' lead product, CytoSorb, is already approved in the EU and distributed in 76 countries, with over a quarter million devices used to date [10] - The company has received FDA Breakthrough Device Designations for DrugSorb-ATR, aimed at reducing perioperative bleeding in high-risk surgeries [11]

Core Viewpoint - CytoSorbents Corporation successfully completed an oversubscribed rights offering, raising $6.25 million, which will enhance its liquidity and satisfy a debt covenant, unlocking an additional $5 million in restricted cash [1][3][4] Group 1: Rights Offering Details - The rights offering was oversubscribed by 68%, with total demand reaching 10,514,896 Units, while the company sold all 6,250,000 Units reserved for the offering [2] - Participants received Units that include one share of common stock and two types of Right Warrants, allowing for the purchase of additional shares [1][2] - The leadership team and Board of Directors subscribed for approximately 450,000 Units prior to any pro-rata adjustments [2] Group 2: Financial Impact - The proceeds from the rights offering satisfy a debt covenant, allowing $5 million of restricted cash to become unrestricted, increasing the company's net liquidity to approximately $10.8 million after related offering fees [3] - The estimated pro forma cash balance as of December 31, 2024, would be approximately $15.4 million, including $13.9 million in unrestricted cash [5] - Excluding the rights offering, the preliminary estimated cash balance was approximately $9.6 million, down from $12.2 million as of September 30, 2024, reflecting a cash burn of approximately $2.6 million in Q4 2024 [6] Group 3: Future Plans and Developments - The CEO expressed optimism about the rights offering's success, which will support innovation and the pursuit of U.S. and Canadian approvals for the DrugSorb-ATR product in 2025 [4] - CytoSorbents is developing the DrugSorb-ATR system to reduce perioperative bleeding in high-risk surgeries, with FDA Breakthrough Device Designations received for its applications [17]