CytoSorbents(CTSO)

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CytoSorbents(CTSO) - 2024 Q2 - Quarterly Results
2024-10-01 12:06
Financial Performance - CytoSorbents Corporation announced preliminary financial results for the quarter ended September 30, 2024, including estimated ranges for quarterly product sales and product gross margins[3] Regulatory Submissions and Approvals - The company submitted its DrugSorb™-ATR medical device De Novo marketing application to the FDA for reducing perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery[3] - DrugSorb-ATR has been granted Breakthrough Device Designation by the FDA, making it eligible for priority review[3] - The company completed its DrugSorb-ATR Health Canada Medical Device License application, pending Medical Device Single Audit Program certification[3]
CytoSorbents(CTSO) - 2024 Q2 - Earnings Call Transcript
2024-08-14 02:31
Financial Data and Key Metrics - Total revenue increased 5% to $9.9 million in Q2 2024, with product sales up 10% to $8.8 million [4] - Gross product margins remained strong at 75% in Q2 2024, compared to 74% in Q2 2023 [4] - Operating loss decreased by 48% to $3.4 million in Q2 2024 from $6.6 million in Q2 2023 [5] - 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 [5] - Annualized cost savings of $5 million expected from recent cutbacks, with a 17% reduction in workforce over the past five months [5] Business Line Data and Key Metrics - CytoSorb product revenue increased by 10% to $8.8 million in Q2 2024 compared to $8.1 million in Q2 2023 [7] - Grant revenue decreased to $1.1 million in Q2 2024 from $1.3 million in Q2 2023 due to the conclusion of several grants [8] - Cumulative delivery of CytoSorb devices surpassed 0.25 million units [4] - The PuriFi hemoperfusion pump received positive reviews and all 30 pumps from the initial order were placed, with the next order expected soon [6] Market Data and Key Metrics - Core non-COVID-19 product sales showed positive growth, with a 9.5% year-over-year increase in trailing 12-month sales ending June 30, 2024 [10] - The STAR registry data was presented at the EuroPCR 2024 Conference and selected as a top five finalist in the best scientific abstract competition [6][16] - The company completed its MDSAP audit, a key requirement for Canadian commercialization [6] Company Strategy and Industry Competition - The company is on track to submit marketing applications for the DrugSorb-ATR system to the FDA and Health Canada in Q3 2024 [6][15] - The company secured a $20 million credit facility with Avenue Capital Group to strengthen its balance sheet [5] - Cost-cutting measures and operational efficiencies are expected to further reduce cash burn and improve margins [13][25] - The company is focusing on expanding its core CytoSorb sales and preparing for potential U.S. and Canadian market entry [26] Management Commentary on Operating Environment and Future Outlook - Management expects gross margins to approach 80% with 15-20% year-over-year growth [36] - The company anticipates FDA and Health Canada regulatory decisions within 6-12 months following the submission of the DrugSorb-ATR application [15] - Management remains committed to cost reduction and operational efficiency to achieve self-sustainability [25] Other Important Information - The company announced the retirement of CFO Kathleen Bloch and the appointment of Peter Mariani as the new CFO [5][29] - The company launched a redesigned corporate and product website [6] - The company received MDR certification for the PuriFi pump and completed registration in Taiwan [24] Q&A Session Summary Question: Update on FDA and Health Canada submission for DrugSorb-ATR - The company is on track for Q3 2024 submissions and believes the STAR-T trial data supports a robust benefit/risk analysis [33][34] Question: Gross margin outlook and factors driving improvement - Gross margins are expected to approach 80% with 15-20% year-over-year growth, driven by volume increases and operational efficiencies [36][39] Question: Revenue growth drivers in Q2 2024 and outlook for Q3 - Revenue growth in Q2 was driven by strength in the distributor and partner channel, particularly with the launch of the PuriFi pump [42][43] Question: Impact of PuriFi pump on revenue growth - The PuriFi pump is expected to drive CytoSorb device sales rather than generate significant hardware revenue [45][46] Question: Timing of Canadian submission for DrugSorb-ATR - The company aims to submit to Health Canada in Q3 2024, prioritizing the FDA submission first [48] Question: R&D expenses and future outlook - R&D expenses decreased to $1.5 million in Q2 2024 due to the completion of the STAR-T trial and focus on grant-funded activities [50] Question: Potential of the Taiwan market - Taiwan represents a significant opportunity due to its large market and strong interest in blood purification, though it remains to be seen how it will develop [51] Question: Status of the $15 million loan - The loan was closed on the last day of Q2 2024 [52] Question: Major grant-supported R&D projects - The company is focusing on HemoDefend-BGA, with progress toward human testing and potential military and civilian applications [53][54]
CytoSorbents Reports Second Quarter 2024 Financial and Operational Results
GlobeNewswire News Room· 2024-08-13 20:19
Core Insights - CytoSorbents Corporation has appointed Peter J. Mariani as the new CFO, succeeding Kathleen P. Bloch, who is retiring after over 11 years with the company [1][11] - The company is on track to submit marketing applications for DrugSorb™-ATR to the U.S. FDA and Health Canada this quarter, which could unlock a significant commercial opportunity with an estimated total addressable market of $325 million [3][34] - In Q2 2024, the company reported a 10% increase in product sales and a 48% reduction in operating loss, achieving a cumulative milestone of over 250,000 CytoSorb treatments delivered [2][8] Financial Performance - Total revenue for Q2 2024 was approximately $9.9 million, a 5% increase from $9.4 million in Q2 2023 [2][15] - Product sales in Q2 2024 reached $8.8 million, up from $8.1 million in Q2 2023, reflecting a 10% increase [2][13] - The operating loss decreased to $3.4 million in Q2 2024 from $6.6 million in the same quarter last year, attributed to cost-cutting measures and increased sales [2][5] Cost Management and Efficiency - The company has implemented additional cost-cutting measures expected to save an additional $5 million annually, reducing headcount by 17% over the past five months [5][6] - Product gross margins improved to approximately 75% in Q2 2024, compared to 74% in Q2 2023, due to operational efficiencies [2][16] - The company aims to achieve 80% blended product gross margins through increased sales volume and improved manufacturing processes [7] Market and Product Development - CytoSorbents has delivered over 250,000 CytoSorb devices across 76 countries, marking a significant achievement in its product distribution [8] - The company is actively working on the launch of its PuriFi® pump and collaborating with Fresenius Medical Care to co-market CytoSorb at upcoming medical conferences [10] - The DrugSorb™-ATR system has received two FDA Breakthrough Device Designations, indicating its potential impact in cardiothoracic procedures [34] Liquidity and Capital Resources - As of June 30, 2024, the company had total cash of $14.9 million, which is expected to fund operations into Q2 2025 [32] - The company secured a $20 million term-loan facility to support its regulatory submissions and operational needs [30][31] - Current assets were approximately $21.96 million, with current liabilities of about $10.34 million, indicating a healthy liquidity position [29][39]
CytoSorbents Appoints Peter J. Mariani Chief Financial Officer
GlobeNewswire News Room· 2024-08-13 20:18
Core Points - CytoSorbents Corporation has appointed Peter J. Mariani as Chief Financial Officer (CFO), effective August 14, 2024, following the retirement of Kathleen P. Bloch [1][3] - Mr. Mariani has over 25 years of experience in financial leadership within high-growth medical device companies, including his recent role as CFO of Axogen, Inc., where he significantly increased annual revenue from $27 million to nearly $160 million [2][3] - The company is pursuing U.S. and Canadian marketing approval for its investigational device, DrugSorb-ATR, which is expected to enhance its growth in the cardiac surgery market [3][4] Company Overview - CytoSorbents Corporation specializes in blood purification technologies for life-threatening conditions in intensive care and cardiac surgery, with its lead product, CytoSorb®, approved in the European Union and distributed in 76 countries [5] - CytoSorb® is designed to reduce cytokine storms and is used during cardiothoracic surgery to mitigate complications such as severe bleeding and organ failure [5] - The company has received FDA Emergency Use Authorization for CytoSorb® in critically ill COVID-19 patients [5] Product Development - The DrugSorb™-ATR system has received two FDA Breakthrough Device Designations for removing specific anticoagulants during cardiothoracic procedures, with a pivotal study completed to support regulatory approval [6] - CytoSorbents has developed various products based on its proprietary polymer adsorption technology, with significant funding received from multiple U.S. government agencies totaling approximately $50 million [7]
CytoSorbents(CTSO) - 2024 Q2 - Quarterly Report
2024-08-13 20:04
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's financial information, including consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited consolidated financial statements for Q2 and H1 2024, including a going concern disclosure due to current cash position - Management expresses substantial doubt about the company's ability to continue as a going concern, as current unrestricted cash is insufficient for operations beyond the next twelve months without additional capital[13](index=13&type=chunk) Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | June 30, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $8,458,708 | $14,131,137 | | Total current assets | $21,955,300 | $25,702,823 | | Total Assets | $53,426,791 | $53,260,634 | | **Liabilities & Equity** | | | | Total current liabilities | $10,336,268 | $14,545,955 | | Long-term debt | $13,673,195 | $2,542,857 | | Total Liabilities | $36,690,188 | $29,985,471 | | Total Stockholders' Equity | $16,736,603 | $23,275,163 | Consolidated Statements of Operations Highlights (Unaudited) | Metric | Q2 2024 ($) | Q2 2023 ($) | H1 2024 ($) | H1 2023 ($) | | :--- | :--- | :--- | :--- | :--- | | Total product sales | $8,841,789 | $8,072,412 | $17,831,309 | $15,982,451 | | Total revenue | $9,894,636 | $9,420,821 | $19,680,928 | $18,870,317 | | Gross profit | $6,502,729 | $6,018,550 | $13,073,307 | $11,473,877 | | Loss from operations | ($3,418,822) | ($6,559,237) | ($8,344,341) | ($14,450,832) | | Net loss | ($4,143,146) | ($6,153,084) | ($10,501,007) | ($13,478,967) | | Basic and diluted net loss per share | ($0.08) | ($0.14) | ($0.19) | ($0.31) | Consolidated Statements of Cash Flows Highlights (Unaudited, Six Months Ended June 30) | Cash Flow Activity | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,624,412) | ($10,041,497) | | Net cash used in investing activities | ($246,883) | ($542,599) | | Net cash provided by financing activities | $9,262,875 | $1,615,401 | | Net change in cash, cash equivalents and restricted cash | ($672,429) | ($8,993,043) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business overview, strategic objectives, financial performance for Q2 and H1 2024, liquidity challenges, and ongoing going concern uncertainty [Overview and Key Objectives](index=42&type=section&id=Overview%20and%20Key%20Objectives) The company, a leader in blood purification, focuses on three key objectives: DrugSorb-ATR regulatory approval, CytoSorb sales growth, and cash burn reduction - The company's three primary strategic objectives include obtaining **FDA and Health Canada marketing approval for DrugSorb™-ATR**, growing **core CytoSorb sales to achieve profitability**, and **reducing cash burn** through expense control[123](index=123&type=chunk) - **CytoSorb** has been used in over **248,000 human treatments globally** and holds CE-Mark label expansions and FDA Emergency Use Authorization for specific conditions[120](index=120&type=chunk) [Clinical Studies Update](index=46&type=section&id=Clinical%20Studies%20Update) The completed STAR-T trial for DrugSorb-ATR met safety but not overall effectiveness, showing reduced bleeding in the CABG subgroup, supporting Q3 2024 regulatory submissions - The pivotal **STAR-T trial** for DrugSorb-ATR met its primary safety endpoint but not overall effectiveness, though it showed **reduced bleeding in the CABG surgery subgroup** (>90% of patients)[130](index=130&type=chunk) - The company plans parallel regulatory submissions of **DrugSorb-ATR to the FDA and Health Canada in Q3 2024** based on STAR-T trial data[130](index=130&type=chunk) - The **STAR-D study** for DOAC removal has been **postponed** to prioritize STAR-T regulatory filings[131](index=131&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) Comparative financial analysis for Q2 and H1 2024 shows increased product sales, improved gross margins, and reduced operating expenses, leading to a lower net loss Revenue Comparison (Q2 2024 vs Q2 2023) | Revenue Source | Q2 2024 ($) | Q2 2023 ($) | Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Product Sales | $8,842,000 | $8,072,000 | +$770,000 | +10% | | Grant Income | $1,053,000 | $1,348,000 | -$295,000 | -22% | | **Total Revenue** | **$9,895,000** | **$9,421,000** | **+$474,000** | **+5%** | Revenue Comparison (H1 2024 vs H1 2023) | Revenue Source | H1 2024 ($) | H1 2023 ($) | Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Product Sales | $17,831,000 | $15,982,000 | +$1,849,000 | +12% | | Grant Income | $1,850,000 | $2,888,000 | -$1,038,000 | -36% | | **Total Revenue** | **$19,681,000** | **$18,870,000** | **+$811,000** | **+4%** | - **R&D expenses decreased by approximately $2.1 million in Q2 2024 and $4.1 million in H1 2024** due to the completion of the STAR-T clinical trial[153](index=153&type=chunk)[159](index=159&type=chunk) - Product gross margins improved from **74% to 75% in Q2 2024** and from **71% to 74% in H1 2024**, driven by operating efficiencies at the new manufacturing facility[152](index=152&type=chunk)[158](index=158&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company had $8.4 million unrestricted cash, raising going concern doubt, despite securing a new $20 million term-loan facility with Avenue Capital Group - The company's **$8.4 million in unrestricted cash** as of June 30, 2024, is expected to fund operations into Q2 2025, raising **substantial doubt about going concern**[167](index=167&type=chunk)[173](index=173&type=chunk) - In June 2024, the company secured a **$20 million term-loan facility with Avenue Capital Group**, with an initial **$15 million tranche funded**, providing **$10 million in unrestricted cash** and repaying existing debt[165](index=165&type=chunk) - The company is pursuing milestones for the Avenue debt facility to potentially release an additional **$5 million in restricted cash** and access another **$5 million tranche**, increasing unrestricted cash by up to **$10 million**[167](index=167&type=chunk)[173](index=173&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that quantitative and qualitative disclosures about market risk are not applicable for this period - Quantitative and qualitative disclosures about market risk are **not applicable** for this reporting period[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=61&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures are effective, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's **disclosure controls and procedures are functioning effectively** as of the period end[176](index=176&type=chunk) - No material changes to **internal control over financial reporting** occurred during the quarter[177](index=177&type=chunk) [PART II. OTHER INFORMATION](index=62&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings) The company is not party to material litigation but is defending against a former employee's CEPA complaint filed March 5, 2024 - A former employee filed a complaint on **March 5, 2024**, alleging retaliatory termination under the **New Jersey CEPA**[180](index=180&type=chunk) - The company disputes the CEPA allegations and intends to **defend vigorously**, though the outcome is not assured[180](index=180&type=chunk) [Item 1A. Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the company's Annual Report on Form 10-K for a comprehensive discussion of business risks - For a discussion of business risks, the company refers to **Part I, Item 1A, 'Risk Factors' in its Annual Report on Form 10-K** for the year ended December 31, 2023[181](index=181&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=62&type=section&id=Other%20Items) The company reports no activity for unregistered sales of equity securities, defaults upon senior securities, mine safety disclosures, or other information - The company reported **'None' or 'Not applicable'** for Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), and Item 5 (Other Information)[181](index=181&type=chunk) [Item 6. Exhibits](index=63&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including XBRL financial statements and Sarbanes-Oxley Act officer certifications - Exhibits include **XBRL financial data** and **officer certifications** pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[182](index=182&type=chunk)
CytoSorbents to Report Second Quarter 2024 Operating and Financial Results
GlobeNewswire News Room· 2024-08-07 11:00
PRINCETON, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report second quarter 2024 operating and financial results after the market close on Tuesday, August 13, 2024. CytoSorbents' management will host a live conference call, presentation webcast, and a question and answer session starting at 4:30PM EDT the same day. Webcast Details: Date: ...
CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website
GlobeNewswire News Room· 2024-07-30 06:00
Core Insights - CytoSorbents Corporation has launched a newly redesigned website that serves as a comprehensive information hub for healthcare professionals, investors, and other stakeholders, emphasizing the theme "Working to Save Lives Together" [1][5][11] Company Overview - CytoSorbents Corporation is a leader in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery, with its flagship product, CytoSorb®, approved in the EU and distributed in 75 countries [11] - The company has developed various products based on proprietary polymer adsorption technology, which has received approximately $50 million in funding from multiple U.S. government agencies [8][11] Website Features - The new website features a user-friendly layout optimized for both desktop and mobile, providing easy access to essential information [2] - It includes a comprehensive resource library with over 1,000 peer-reviewed publications and other materials related to the company's therapies [2] - The site also offers dedicated sections for news updates, investor relations, and improved contact forms for faster communication [2] Product Information - CytoSorb® is designed to reduce cytokine storms in critical illnesses, with over 237,000 devices used cumulatively as of March 31, 2024 [11] - The DrugSorb™-ATR system, an investigational device, has received two FDA Breakthrough Device Designations for removing specific anticoagulants during cardiothoracic procedures [12]
CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website
Newsfilter· 2024-07-29 12:00
PRINCETON, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, is proud to announce the launch of its newly redesigned and consolidated website at www.cytosorbents.com. The theme of "Working to Save Lives Together" highlights two decades of successful collaboration with the international medical and research com ...
CytoSorbents to Present at the Inaugural American Association of Physicians of Indian Origin (AAPI) World Health Congress
Newsfilter· 2024-07-17 11:00
Company Overview - CytoSorbents Corporation (NASDAQ: CTSO) specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [1][7] - The company's lead product, CytoSorb®, is an extracorporeal cytokine adsorber that mitigates "cytokine storm" in critical illnesses, significantly reducing inflammation and organ failure risks [7] - As of March 31, 2024, over 237,000 CytoSorb devices have been utilized globally, with the product approved in the European Union and distributed in 75 countries [7] Recent Developments - CytoSorbents will present at the 1st Annual American Association of Physicians of Indian Origin (AAPI) World Health Congress from July 18-22, 2024, in New York, engaging with over 3,000 healthcare professionals [1][2] - Dr. Phillip Chan, CEO of CytoSorbents, will participate in a panel discussion on the role of artificial intelligence in healthcare, highlighting the company's historical involvement with DARPA in developing smart diagnostic systems for sepsis [1][6] Product Innovations - The DrugSorb™-ATR system, an investigational device for antithrombotic removal, has received two FDA Breakthrough Device Designations for use in urgent cardiothoracic procedures [3][11] - CytoSorbents' technologies are supported by approximately $50 million in funding from various U.S. government agencies, indicating strong institutional backing for its research and development efforts [8] Market Position - The AAPI represents over 80,000 practicing physicians in the U.S., with its members accounting for about 10% of all physicians and serving approximately 30% of the U.S. patient population, providing a significant platform for CytoSorbents to increase awareness of its technologies [2]
CytoSorbents to Present at the Inaugural American Association of Physicians of Indian Origin (AAPI) World Health Congress
GlobeNewswire News Room· 2024-07-17 11:00
PRINCETON, N.J., July 17, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces it will present at the 1st Annual American Association of Physicians of Indian Origin (AAPI) World Health Congress, taking place on July 18- 22, 2024 at the Mariott Marquis Hotel in New York, NY. This event will host over 3,000 ph ...