Cytosorbents Corporation. (NASDAQ:CTSO) Q2 2023 Earnings Conference Call August 1, 2023 4:30 PM ET Company Participants Taylor Devlin - Revenue Accountant Phillip Chan - Chief Executive Officer Vincent Capponi - President and Chief Operating Officer Kathleen Bloch - Interim Chief Financial Officer Efthymios Deliargyris - Chief Medical Officer Christopher Cramer - Senior Vice President of Business Development Irina Kulinets - Senior Vice President of Regulatory Conference Call Participants Joshua Jennings - ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36792 CYTOSORBENTS CORPORATION (Exact name of registrant as specified in its charter) Delaware 98-0373793 (State or other jurisdiction of (I.R.S. Employer ...

Cytosorbents Corporation (NASDAQ:CTSO) Q1 2023 Results Earnings Conference Call May 2, 2023 4:30 AM ET Company Participants Taylor Devlin - Revenue Accountant Phillip Chan - Chief Executive Officer Kathleen Bloch - Interim Chief Financial Officer Efthymios Deliargyris - Chief Medical Officer Christian Steiner - Executive Vice President of Sales and Marketing Conference Call Participants Thomas Kerr - Zacks Investment Research Sean Lee - H.C. Wainwright & Co. Operator Good afternoon and welcome to the Cytoso ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36792 CYTOSORBENTS CORPORATION (Exact name of registrant as specified in its charter) incorporation or organization) 305 College Road East Princeton, New ...

Cytosorbents Corporation (NASDAQ:CTSO) Q4 2022 Earnings Conference Call March 9, 2023 4:30 PM ET Company Participants Jodi Hoover – Manager-Clinical Administration Phillip Chan – Chief Executive Officer Irina Kulinets – Senior Vice President-Global Regulatory Kathleen Bloch – Chief Financial Officer Efthymios Deliargyris – Chief Medical Officer Vincent Capponi – President and Chief Operating Officer Christian Steiner – Executive Vice President-Sales and Marketing and Managing Director-CytoSorbents Europe Gm ...

In the EU, as in other geographies, there are limits to the claims we are allowed to make, associated with the use of our devices. Specifically, claims that are made are required to be included in our Clinical Evaluation Report, which is part of the conformity assessment process conducted by the Notified Body. If our claims exceed the assessed claims, either regarding performance or intended uses, we may be subject to regulatory actions, which could include customer notifications or even product or literatu ...

CytoSorbents Corporation (NASDAQ:CTSO) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Michelle Almonte - Executive Assistant to CEO Phillip Chan - Chief Executive Officer Kathleen Bloch - Chief Financial Officer Christian Steiner - EVP of Sales and Marketing and Managing Director of CytoSorbents Europe GmbH Efthymios Deliargyris - Chief Medical Officer Vincent Capponi - Chief Operating Officer and President Christopher Cramer - VP of Business Development Conference Call Pa ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36792 CYTOSORBENTS CORPORATION (Exact name of registrant as specified in its charter) Delaware 98-0373793 (State or other jurisdiction of (I.R.S. Empl ...

Cytosorbents Corporation (NASDAQ:CTSO) Q2 2022 Earnings Conference Call August 2, 2022 4:30 PM ET Company Participants Amy Vogel – Investor Relations Phillip Chan – Chief Executive Officer Kathleen Bloch – Chief Financial Officer Christian Steiner – Executive Vice President-Sales and Marketing and Managing Director-Cytosorbents Europe GmbH Christopher Cramer – Vice President-Business Development Efthymios Deliargyris – Chief Medical Officer Vincent Capponi – Chief Operating Officer and President Mike Gibson ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited consolidated financial statements for Q2 and H1 2022 and 2021 detail the company's financial position and performance Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 30,164,055 | 52,137,707 | | Total Assets | 71,205,278 | 89,519,282 | | Total Liabilities | 23,645,511 | 26,941,085 | | Total Stockholders' Equity | 47,559,767 | 62,578,197 | Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2022 ($) | Three Months Ended June 30, 2021 ($) | Six Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | 8,495,558 | 12,024,069 | 17,186,982 | 22,622,916 | | Gross margin | 4,944,856 | 9,313,852 | 11,358,643 | 17,161,255 | | Loss from operations | (8,357,050) | (4,924,733) | (16,148,185) | (7,776,923) | | Net loss | (10,879,222) | (4,677,530) | (19,845,620) | (8,845,351) | | Net loss per share | (0.25) | (0.11) | (0.46) | (0.20) | Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (16,159,163) | (4,380,482) | | Net cash used in investing activities | (5,532,963) | (1,591,018) | | Net cash provided by (used in) financing activities | (40,359) | 206,405 | | Net change in cash, cash equivalents and restricted cash | (21,973,652) | (5,812,523) | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail accounting policies, going concern status, product approvals, revenue breakdown, and a significant subsequent marketing agreement - The company is a leader in blood purification for life-threatening conditions, with its flagship product **CytoSorb** approved in the EU and under **Emergency Use Authorization (EUA)** in the US for COVID-19, and has received two **FDA Breakthrough Designations** for its **DrugSorb-ATR system**[30](index=30&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk) - As of June 30, 2022, the company had **$31.9 million** in cash, cash equivalents, and restricted cash, which, along with **$15 million** of debt availability and a **$25 million** ATM facility, is believed sufficient to fund operations for **more than twelve months**, mitigating going concern risk[29](index=29&type=chunk) Revenue by Geography (Six Months Ended June 30) | Region | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Germany (Product Sales) | 6,766,295 | 12,016,342 | | All other countries (Product Sales) | 7,965,921 | 8,826,783 | | United States (Product Sales) | 522,976 | 665,681 | | United States (Grant Income) | 1,931,790 | 1,114,110 | | **Total Revenue** | **17,186,982** | **22,622,916** | - Subsequent to the quarter end, on **August 1, 2022**, the company entered into a **multi-year global marketing agreement** with Fresenius Medical Care to promote CytoSorb worldwide (excluding the U.S.), with CytoSorbents paying Fresenius a royalty of **0.9%** of applicable net sales to support these efforts[132](index=132&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses financial performance, key objectives, and liquidity, highlighting a **29% Q2 2022 revenue decrease** and focus on FDA approval and strategic partnerships [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Q2 2022 total revenues decreased **29% to $8.5 million**, driven by a **36% drop in product sales** due to currency and reduced COVID-19 demand, resulting in a widened net loss Q2 2022 vs Q2 2021 Performance | Metric | Q2 2022 ($M) | Q2 2021 ($M) | Change (%) | | :--- | :--- | :--- | :--- | | Product Sales | 7.3 | 11.4 | -36 | | Total Revenue | 8.5 | 12.0 | -29 | | Product Gross Margin | 67% | 82% | -15 p.p. | | R&D Expenses | 4.2 | 3.7 | +13 | | Net Loss | (10.9) | (4.7) | +132 | - The decrease in Q2 2022 product sales was primarily caused by an unfavorable currency impact of **~$840,000** and a decline in COVID-19 related demand, which was estimated to be de minimis in Q2 2022 compared to **~$1.7 million** in Q2 2021[186](index=186&type=chunk) - Product gross margin fell to **67%** in Q2 2022 from **82%** in Q2 2021, mainly due to production inefficiencies associated with the relocation to the new manufacturing facility in Princeton, NJ[190](index=190&type=chunk) - The company recorded a foreign currency transaction loss of **$2.5 million** in Q2 2022, compared to a gain of **$0.2 million** in Q2 2021, due to the weakening of the Euro against the U.S. dollar[194](index=194&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, the company held **$31.9 million** in cash and equivalents, with additional facilities, sufficient to fund operations for over twelve months despite a **$12.9 million Q2 cash burn** - The company holds **$31.9 million** in cash, cash equivalents, and restricted cash as of June 30, 2022[207](index=207&type=chunk)[226](index=226&type=chunk) - Additional liquidity includes **$15 million** of debt availability and **$25 million** available under an ATM facility[206](index=206&type=chunk)[226](index=226&type=chunk) - Q2 2022 cash burn was approximately **$12.9 million**, including **$4.8 million** in non-recurring expenditures for the new manufacturing facility, with an adjusted burn of approximately **$6.5 million** excluding these and other factors[207](index=207&type=chunk) - Management believes it has sufficient cash to fund operations beyond **twelve months** from the issuance of the financial statements[210](index=210&type=chunk)[226](index=226&type=chunk) [Clinical and Business Updates](index=32&type=section&id=Clinical%20and%20Business%20Updates) The company focuses on U.S. FDA approval for DrugSorb-ATR, growing CytoSorb sales, manufacturing transition, and strategic partnerships, with pivotal trials completing in **2023** - The company's four key objectives are: 1) Open the U.S. market with **FDA approval for DrugSorb-ATR**, 2) **Grow core CytoSorb sales to profitability**, 3) **Transition production to the new New Jersey facility**, and 4) **Forge and expand strategic partnerships**[145](index=145&type=chunk) - The U.S. pivotal trials, STAR-T and STAR-D, are actively enrolling patients to support FDA marketing approval for DrugSorb-ATR, with enrollment expected to be completed in **2023**[156](index=156&type=chunk)[157](index=157&type=chunk) - A new **3-year** preferred supplier agreement with Asklepios makes CytoSorb available to approximately **170 healthcare facilities** across Germany[167](index=167&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is foreign currency exchange rates, particularly the Euro, impacting revenue but partially offset by a natural hedge from Euro-denominated operating expenses - The company's main market risk is **foreign currency exchange rates**, as the majority of its sales are in **Euros**[228](index=228&type=chunk) - A **natural currency hedge** exists because a decline in the Euro that reduces revenue also reduces the U.S. dollar equivalent of Euro-denominated operating expenses[228](index=228&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, 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 were **effective** as of the end of the period covered by the report[230](index=230&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[231](index=231&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings - The company is **not currently a party** to any legal proceedings[234](index=234&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the detailed discussion of risk factors in the Annual Report on Form 10-K filed on March 10, 2022 - For a discussion of risks affecting the company, readers are referred to the 'Risk Factors' section in the Annual Report on Form 10-K filed on **March 10, 2022**[235](index=235&type=chunk) [Other Part II Items](index=50&type=section&id=Other%20Part%20II%20Items) This section covers remaining Part II items, reporting no unregistered sales of equity securities, no defaults, no mine safety disclosures, and listing filed exhibits including officer certifications - The company reported **no unregistered sales of equity securities**, **no defaults upon senior securities**, or other material information for the period[237](index=237&type=chunk)[239](index=239&type=chunk)[243](index=243&type=chunk) - The exhibits filed with the report include **certifications by the Principal Executive Officer and Principal Financial Officer** as required by the Sarbanes-Oxley Act[245](index=245&type=chunk)