Cytosorbents Corp 10-Q

Item 1. Financial Statements. CYTOSORBENTS CORPORATION CONSOLIDATED BALANCE SHEETS ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ ​ ​ 2020 ​ December 31, ​ ​ (Unaudited) 2019 ASSETS ​ ​ ​ Current Assets: ​ ​ ​ Cash and cash equivalents ​ $ 87,978,343 ​ $ 12,232,418 Grants and accounts receivable, net of allowance for doubtful accounts of $ 69,640 at September 30, 2020 and $ 145,313 at December 31, 2019 ​ 5,797,306 ​ 4,467,087 Inventories ​ 2,024,934 ​ 2,113,897 Prepaid expenses and other current assets ​ 1,002,401 ​ 2,088,127 Total current assets ​ 96,802,984 ​ 20,901,529 ​ ​ ​ ​ Property and equipment, net ​ 2,077,542 ​ 1,925,325 Right of use asset ​ ​ 1,131,915 ​ ​ 1,070,762 Other assets ​ 4,269,637 ​ 3,484,894 Total Assets ​ $ 104,282,078 ​ $ 27,382,510 ​ ​ ​ LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ Current Liabilities: ​ ​ Accounts payable ​ $ 2,386,361 ​ $ 2,039,222 Current maturities of long-term debt ​ 9,166,667 ​ 1,666,666 Lease liability – current portion ​ ​ 432,423 ​ ​ 428,083 Accrued expenses and other current liabilities ​ 5,370,857 ​ 5,802,296 Total current liabilities ​ 17,356,308 ​ 9,936,267 ​ ​ ​ Long term debt, net of current maturities and debt issuance costs ​ 5,993,125 ​ 13,385,522 Lease liability, net of current portion ​ ​ 699,492 ​ ​ 642,679 Total Liabilities ​ 24,048,925 ​ 23,964,468 Commitments and Contingencies (Note 6) ​ ​ Stockholders’ Equity: ​ ​ Preferred Stock, Par Value $ 0.001 , 5,000,000 shares authorized; -0- shares issued and outstanding at September 30, 2020 and December 31, 2019 ​ ​ — ​ ​ — Common Stock, Par Value $ 0.001 , 100,000,000 shares authorized; 43,175,685 and 32,616,107 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively ​ 43,176 ​ 32,616 Additional paid-in capital ​ 276,656,202 ​ 191,648,907 Accumulated other comprehensive income (loss) ​ ( 517,302 ) ​ 525,978 Accumulated deficit ​ ( 195,948,923 ) ​ ( 188,789,459 ) Total Stockholders’ Equity ​ 80,233,153 ​ 3,418,042 Total Liabilities and Stockholders’ Equity ​ $ 104,282,078 ​ $ 27,382,510 ​ See accompanying notes to consolidated financial statements . ​ 3 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended ​ Nine months ended ​ ​ September 30, ​ September 30, ​ ​ 2020 ​ 2019 ​ 2020 ​ 2019 ​ (Unaudited) (Unaudited) (Unaudited) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue: ​ ​ ​ ​ CytoSorb sales ​ $ 10,245,642 ​ $ 5,648,463 ​ $ 27,852,940 ​ $ 16,008,659 Other sales ​ — ​ 80,000 ​ 69,000 ​ 146,800 Total product sales ​ 10,245,642 ​ 5,728,463 ​ 27,921,940 ​ 16,155,459 Grant income ​ 300,970 ​ 366,544 ​ 1,126,885 ​ 1,363,703 Total revenue ​ 10,546,612 ​ 6,095,007 ​ 29,048,825 ​ 17,519,162 Cost of revenue ​ 2,890,382 ​ 1,696,274 ​ 8,524,991 ​ 5,269,228 Gross margin ​ 7,656,230 ​ 4,398,733 ​ 20,523,834 ​ 12,249,934 Other expenses: ​ ​ ​ ​ Research and development ​ 1,753,455 ​ 3,185,105 ​ 6,124,780 ​ 8,533,342 Legal, financial and other consulting ​ 580,067 ​ 733,297 ​ 1,944,930 ​ 1,886,851 Selling, general and administrative ​ 7,282,357 ​ 6,107,877 ​ 20,190,193 ​ 15,372,476 Total expenses ​ 9,615,879 ​ 10,026,279 ​ 28,259,903 ​ 25,792,669 Loss from operations ​ ( 1,959,649 ) ​ ( 5,627,546 ) ​ ( 7,736,069 ) ​ ( 13,542,735 ) ​ ​ ​ ​ ​ Other income/(expense): ​ ​ ​ ​ Interest expense, net ​ ( 260,617 ) ​ ( 301,972 ) ​ ( 839,972 ) ​ ( 721,703 ) Gain (loss) on foreign currency transactions ​ 1,380,537 ​ ( 955,543 ) ​ 1,416,577 ​ ( 1,051,854 ) Total other income (expense), net ​ 1,119,920 ​ ( 1,257,515 ) ​ 576,605 ​ ( 1,773,557 ) ​ ​ ​ ​ ​ Net loss before benefit from income taxes ​ ( 839,729 ) ​ ( 6,885,061 ) ​ ( 7,159,464 ) ​ ( 15,316,292 ) Benefit from income taxes ​ — ​ — ​ — ​ — ​ ​ ​ ​ ​ Net loss attributable to common shareholders ​ $ ( 839,729 ) ​ $ ( 6,885,061 ) ​ $ ( 7,159,464 ) ​ $ ( 15,316,292 ) ​ ​ ​ ​ ​ Basic and diluted net loss per common share ​ $ ( 0.02 ) ​ $ ( 0.21 ) ​ $ ( 0.19 ) ​ $ ( 0.48 ) Weighted average number of shares of common stock outstanding ​ 41,593,218 ​ 32,365,700 ​ 37,350,564 ​ 32,189,430 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 839,729 ) ​ $ ( 6,885,061 ) ​ $ ( 7,159,464 ) ​ $ ( 15,316,292 ) Other comprehensive income (loss): ​ ​ ​ ​ Currency translation adjustment ​ ( 1,047,749 ) ​ 811,763 ​ ( 1,043,280 ) ​ 868,243 Comprehensive loss ​ $ ( 1,887,478 ) ​ $ ( 6,073,298 ) ​ $ ( 8,202,744 ) ​ $ ( 14,448,049 ) ​ See accompanying notes to consolidated financial statements. ​ 4 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY For the three and nine months ended September 30, 2020 (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ Shares Par value Capital Income (Loss) Deficit Equity Balance at June 30, 2020 ​ 36,811,870 ​ $ 36,812 ​ $ 218,864,425 ​ $ 530,447 ​ $ ( 195,109,194 ) ​ $ 24,322,490 Stock based compensation - employees, consultants and directors ​ — ​ ​ — ​ ​ 1,088,173 ​ ​ — ​ ​ — ​ ​ 1,088,173 Issuance of common stock, net of fees ​ 6,294,998 ​ ​ 6,295 ​ ​ 56,195,080 ​ ​ — ​ ​ — ​ ​ 56,201,375 Other comprehensive (loss): foreign translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ ( 1,047,749 ) ​ ​ — ​ ​ ( 1,047,749 ) Proceeds from exercise of stock options ​ 35,823 ​ ​ 36 ​ ​ 179,716 ​ ​ — ​ ​ — ​ ​ 179,752 Issuance of restricted stock units ​ 32,994 ​ ​ 33 ​ ​ 328,808 ​ ​ — ​ ​ — ​ ​ 328,841 Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 839,729 ) ​ ​ ( 839,729 ) Balance at September 30, 2020 ​ 43,175,685 ​ $ 43,176 ​ $ 276,656,202 ​ $ ( 517,302 ) ​ $ ( 195,948,923 ) ​ $ 80,233,153 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2019 ​ 32,616,107 ​ $ 32,616 ​ $ 191,648,907 ​ $ 525,978 ​ $ ( 188,789,459 ) ​ $ 3,418,042 Stock based compensation - employees, consultants and directors — ​ — ​ 2,863,805 ​ — ​ — ​ 2,863,805 Issuance of common stock, net of fees ​ 10,163,256 ​ ​ 10,163 ​ ​ 80,203,845 ​ ​ — ​ ​ — ​ ​ 80,214,008 Other comprehensive income: foreign translation adjustment — ​ — ​ — ​ ( 1,043,280 ) ​ — ​ ( 1,043,280 ) Proceeds from exercise of stock options 298,075 ​ 298 ​ 1,281,964 ​ — ​ — ​ 1,282,262 Cashless exercise of stock options 10,519 ​ 11 ​ ( 11 ) ​ — ​ — ​ — Issuance of restricted stock units ​ 87,728 ​ ​ 88 ​ ​ 657,692 ​ ​ — ​ ​ — ​ ​ 657,780 Net loss — ​ — ​ — ​ — ​ ( 7,159,464 ) ​ ( 7,159,464 ) Balance at September 30, 2020 43,175,685 ​ $ 43,176 ​ $ 276,656,202 ​ $ ( 517,302 ) ​ $ ( 195,948,923 ) ​ $ 80,233,153 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ Shares Par value Capital Income Deficit Equity Balance at June 30, 2019 ​ 32,303,231 ​ ​ 32,303 ​ ​ 189,120,749 ​ ​ 344,655 ​ ​ ( 177,955,046 ) ​ ​ 11,542,661 Stock based compensation - employees, consultants and directors ​ — ​ ​ — ​ ​ 802,334 ​ ​ — ​ ​ — ​ ​ 802,334 Other comprehensive income: foreign translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ 811,763 ​ ​ — ​ ​ 811,763 Proceeds from exercise of stock options ​ 86,600 ​ ​ 87 ​ ​ 312,159 ​ ​ — ​ ​ — ​ ​ 312,246 Issuance of restricted stock units ​ 32,432 ​ ​ 32 ​ ​ 237,697 ​ ​ — ​ ​ — ​ ​ 237,729 Fees related to Open Market Sales Agreement ​ — ​ ​ — ​ ​ ( 87,881 ) ​ ​ — ​ ​ — ​ ​ ( 87,881 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 6,885,061 ) ​ ​ ( 6,885,061 ) Balance at September 30, 2019 ​ 32,422,263 ​ $ 32,422 ​ $ 190,385,058 ​ $ 1,156,418 ​ $ ( 184,840,107 ) ​ $ 6,733,791 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2018 ​ 31,774,139 ​ $ 31,774 ​ $ 186,138,466 ​ $ 288,175 ​ $ ( 169,523,815 ) ​ $ 16,934,600 Stock based compensation - employees, consultants and directors — ​ — ​ 1,174,755 ​ — ​ — ​ 1,174,755 Other comprehensive income: foreign translation adjustment — ​ — ​ — ​ 868,243 ​ — ​ 868,243 Proceeds from exercise of stock options 171,134 ​ 172 ​ 728,335 ​ — ​ — ​ 728,507 Cashless exercise of warrants 9,029 ​ 9 ​ ( 9 ) ​ — ​ — ​ — Issuance of restricted stock units 84,249 ​ 84 ​ 663,284 ​ — ​ — ​ 663,368 Cashless exercise of stock options ​ 23,354 ​ ​ 22 ​ ​ ( 22 ) ​ ​ — ​ ​ — ​ ​ — Fees related to Open Market Sales Agreement ​ — ​ ​ — ​ ​ ( 87,881 ) ​ ​ — ​ ​ — ​ ​ ( 87,881 ) Proceeds from exercise of warrants 360,358 ​ 361 ​ 1,768,130 ​ — ​ — ​ 1,768,491 Net loss — ​ — ​ — ​ — ​ ( 15,316,292 ) ​ ( 15,316,292 ) Balance at September 30, 2019 32,422,263 ​ $ 32,422 ​ $ 190,385,058 ​ $ 1,156,418 ​ $ ( 184,840,107 ) ​ $ 6,733,791 ​ See accompanying notes to consolidated financial statements. ​ 5 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF CASH FLOWS ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine months ended Nine months ended ​ ​ September 30, ​ September 30, ​ ​ 2020 ​ 2019 ​ ​ (Unaudited) ​ (Unaudited) Cash flows from operating activities: ​ ​ Net loss ​ $ ( 7,159,464 ) ​ $ ( 15,316,292 ) Adjustments to reconcile net loss to net cash used by operating activities: ​ ​ Non-cash compensation ​ 994,981 ​ 1,006,960 Depreciation and amortization ​ 494,996 ​ 414,115 Amortization of debt costs ​ 107,604 ​ 79,338 Bad debt recoveries ​ ( 77,636 ) ​ ( 44,186 ) Stock-based compensation ​ 2,863,805 ​ 1,174,755 Foreign currency transaction (gain) loss ​ ( 1,416,577 ) ​ 1,051,854 Changes in operating assets and liabilities: ​ ​ Grants and accounts receivable ​ ( 1,083,938 ) ​ 408,783 Inventories ​ 128,727 ​ ( 964,478 ) Prepaid expenses and other current assets ​ 1,104,461 ​ ( 43,645 ) Other assets ​ — ​ 4,047 Accounts payable and accrued expenses ​ ( 512,439 ) ​ ( 405,820 ) Net cash used by operating activities ​ ( 4,555,480 ) ​ ( 12,634,569 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from investing activities: ​ ​ Purchases of property and equipment ​ ( 546,389 ) ​ ( 557,411 ) Payments for patent costs ​ ( 863,693 ) ​ ( 559,483 ) Net cash used by investing activities ​ ( 1,410,082 ) ​ ( 1,116,894 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from financing activities: ​ ​ Equity contributions-net of fees ​ 80,214,008 ​ — Fees related to equity facility ​ ​ — ​ ​ ( 87,881 ) Proceeds from long-term debt ​ 1,410,900 ​ 5,000,000 Repayment of long-term debt ​ ( 1,410,900 ) ​ — Payment of debt acquisition costs ​ ​ — ​ ​ ( 4,212 ) Proceeds from exercise of stock options ​ 1,282,262 ​ 728,507 Proceeds from exercise of warrants ​ — ​ 1,768,491 Net cash provided by financing activities ​ 81,496,270 ​ 7,404,905 Effect of exchange rates on cash ​ 215,217 ​ ( 44,336 ) Net change in cash and cash equivalents ​ 75,745,925 ​ ( 6,390,894 ) ​ ​ ​ ​ ​ ​ ​ Cash and cash equivalents - beginning of period ​ 12,232,418 ​ 22,368,837 Cash and cash equivalents - end of period ​ $ 87,978,343 ​ $ 15,977,943 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of cash flow information: ​ ​ Cash paid during the period for interest ​ $ 883,857 ​ $ 732,537 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of non-cash financing activities ​ ​ Settlement of accrued bonuses with restricted stock units ​ $ 657,780 ​ $ 425,639 ​ See accompanying notes to financial statements. ​ 6 Table of Contents CytoSorbents Corporation Notes to Consolidated Financial Statements (UNAUDITED) September 30, 2020 1. BASIS OF PRESENTATION The interim consolidated financial statements of CytoSorbents Corporation (the “Company”) have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments, for a fair statement of the Company’s consolidated financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes for the year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2020. The results for the three and nine months ended September 30, 2020 and 2019 are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period. Prior to June 30, 2020, the Company's consolidated financial statements were prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. On July 24, 2020, the Company closed an underwritten public offering of 6,052,631 shares of its common stock at a public offering price of $ 9.50 per share (the “Offering”). Gross proceeds from the Offering amounted to approximately $ 57.5 million and, after deducting the underwriting discounts and commissions and expenses related to the Offering, the Company received total net proceeds of approximately $ 53.8 million. See Note 3. As of September 30, 2020, the Company’s cash balance was approximately $ 88.0 million, which the Company expects will fund the Company’s operations well beyond the next twelve months. As a result, the Company has determined that the going concern risk has been eliminated. ​ 2. PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Business The Company is a leader in critical care immunotherapy using blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world. The Company, through its subsidiary CytoSorbents Medical, Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the CytoSorb device. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. In November 2018, the Company formed CytoSorbents Poland Sp. z.o.o., a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the first quarter of 2019, provides marketing and direct sales services in Poland. In the third quarter of 2019, the Company formed CytoSorbents UK Limited, a wholly-owned subsidiary of CytoSorbents Medical, Inc. which is responsible for the management of our clinical trial activities in the United Kingdom. CytoSorb, the Company’s flagship product, was approved in the European Union (“EU”) in March 2011, and is currently being marketed and distributed in sixty-six countries around the world, as a safe and effective extracorporeal cytokine absorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. In May 2018, the Company received a label extension for CytoSorb covering use of the device for the removal of bilirubin and myoglobin which allows for the use of the device in the treatment of liver failure and trauma, respectively. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. In April 2020, the Company announced that the United States Food and Drug Administration (the “FDA”) granted Emergency Use Authorization (“EUA”) of CytoSorb for use in critically-ill patients infected with COVID-19. Under the EUA, the Company can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who 7 Table of Contents have early acute lung injury or acute respiratory distress syndrome (ARDS), severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure. The CytoSorb device has neither been cleared nor approved for the indication to treat patients with COVID-19 infection. The EUA will be effective until a declaration is made that the circumstances justifying the EUA have terminated or until revoked by the FDA. In April 2020, the Company also announced that the FDA had granted Breakthrough Designation to CytoSorb for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. The Breakthrough Devices Program provides for more effective treatment of life-threatening or irreversibly debilitating disease or conditions, in this case the need to reverse the effects of ticagrelor in emergent or urgent cardiac surgery that can otherwise cause a high risk of serious or life-threatening bleeding. Through Breakthrough Designation, the FDA intends to work with CytoSorbents to expedite the development, assessment, and regulatory review of CytoSorb for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k) or premarket approval ) consistent with the FDA’s mission to protect and promote public health. The technology is based upon biocompatible, highly porous polymer sorbent beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. The Company has numerous products under development based upon this unique blood purification technology, which is protected by 19 issued U.S. patents and multiple international patents, with applications pending both in the U.S. and internationally, including HemoDefend, ContrastSorb, DrugSorb, and others. These patents and patent applications are directed to various compositions and methods of use related to our blood purification technologies and are expected to expire between 2020 and 2035, absent any patent term extensions. Management believes that any near term expiring patents will not have a significant impact on our ongoing business. Stock Market Listing On December 17, 2014 the Company’s common stock, par value $ 0.001 per share, was approved for listing on the Nasdaq Capital Market (“Nasdaq”), and it began trading on Nasdaq on December 23, 2014 under the symbol “CTSO.” Previously, the Company’s common stock traded in the over-the-counter-market on the OTC Bulletin Board. Basis of Consolidation and Foreign Currency Translation The consolidated financial statements include the accounts of CytoSorbents Corporation and its wholly-owned subsidiaries, CytoSorbents Medical, Inc. and CytoSorbents Europe GmbH. In addition, the consolidated financial statements include CytoSorbents Switzerland GmbH and CytoSorbents Poland Sp. z.o.o., wholly owned subsidiaries of CytoSorbents Europe GmbH. All significant intercompany transactions and balances have been eliminated in consolidation. Translation gains and losses resulting from the process of remeasuring into the United States Dollar, the foreign currency financial statements of CytoSorbents Europe GmbH, for which the Euro is the functional currency, are included in operations. Foreign currency transaction gain (loss) included in net loss amounted to approximately $ 1,381,000 and $( 956,000 ) for the three months ended September 30, 2020 and 2019, respectively. Foreign currency transaction gain (loss) included in net loss amounted to approximately $ 1,417,000 and $( 1,052,000 ) for the nine months ended September 30, 2020 and 2019, respectively. The Company translates assets and liabilities of CytoSorbents Europe GmbH at the exchange rate in effect at the consolidated balance sheet date. The Company translates revenue and expenses at the daily average exchange rates. The Company includes accumulated net translation adjustments in accumulated other comprehensive income (loss) as a component of stockholders’ equity. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Grants and Accounts Receivable Grants receivable represent amounts due from U.S. government agencies and are included in Grants and Accounts Receivable. Accounts receivable are unsecured, non-interest bearing customer obligations due under normal trade terms. The Company sells its devices to various hospitals and distributors. The Company performs ongoing credit evaluations of its customers’ financial conditions. 8 Table of Contents Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. Inventories Inventories are valued at the lower of cost or net realizable value under the first in, first out (FIFO) method. At September 30, 2020 and December 31, 2019, the Company’s inventory was comprised of finished goods, which amounted to $ 637,735 and $ 305,452 , respectively; work in process which amounted to $ 1,137,834 and $ 1,523,923 , respectively; and raw materials, which amounted to $ 249,365 and $ 284,522 , respectively. Devices used in clinical trials or for research and development purposes are removed from inventory and charged to research and development expenses at the time of their use. Property and Equipment Property and equipment are recorded at cost less accumulated depreciation. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the lesser of their economic useful lives or the term of the related leases. Gains and losses on depreciable assets retired or sold are recognized in the consolidated statements of operations and comprehensive loss in the year of disposal. Repairs and maintenance expenditures are expensed as incurred. Patents Legal costs incurred to establish and successfully defend patents are capitalized. When patents are issued, capitalized costs are amortized on the straight-line method over the related patent term. In the event a patent is abandoned, the net book value of the patent is written off. Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of patents and other long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. Revenue Recognition Product Sales : Revenues from sales of products to both direct and distributor/strategic partner customers are recognized at the time when control passes to the customer, in accordance with the terms of their respective contracts. Recognition of revenue occurs as each performance obligation is completed. Grant Income : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs; other agreements provide for reimbursement of costs and an overhead margin and certain agreements are performance based, where revenue is earned based upon the achievement of milestones outlined in the contract. Revenues are recognized when the associated performance obligation is fulfilled. Costs are recorded as incurred. Costs subject to reimbursement by these grants have been reflected as costs of revenue. Research and Development All research and development costs, payments to laboratories and research consultants are expensed when incurred. Advertising Expenses Advertising expenses are charged to activities when incurred. Advertising expenses amounted to approximately $ 32,000 and $ 70,000 for the three months ended September 30, 2020 and 2019, respectively, and approximately $ 118,000 and $ 215,000 for the nine months ended September 30, 2020 and 2019, respectively, and are included in selling, general, and administrative expenses on the consolidated statements of operations. 9 Table of Contents Income Taxes Income taxes are accounted for under the asset and liability method prescribed by accounting standards for accounting for income taxes. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized. The Company has provided a valuation allowance against all deferred tax assets. Under Section 382 of the Internal Revenue Code, the net operating losses generated prior to the previously completed reverse merger may be limited due to the change in ownership. Additionally, net operating losses generated subsequent to the reverse merger may be limited in the event of changes in ownership. The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits at September 30, 2020 or December 31, 2019. The Company files tax returns in the U.S. federal and state jurisdictions. The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carry forwards to an industrial company. Each of CytoSorbents Europe GmbH, CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. Z.o.o. and CytoSorbents UK Limited file an annual corporate tax return, VAT return and a trade tax return in Germany, Switzerland, Poland and the United Kingdom, respectively. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities. Actual results could differ from these estimates. The valuation of options granted is a significant estimate in these consolidated financial statements. Concentration of Credit Risk The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances. A significant portion of our revenues are from product sales in Germany. Substantially all of our grant and other income are from grant agencies in the United States. (See Note 4 for further information relating to the Company’s revenue.) As of September 30, 2020, one distributor accounted for approximately 20 % of outstanding grants and accounts receivable. As of December 31, 2019, no agency, distributor/strategic partners or direct customer represented more than 10 % of outstanding grants and accounts receivables. For the three months ended September 30, 2020, one distributor accounted for approximately 13 % of the Company's total revenue. For the nine months ended September 30, 2020, no agency, distributor, or direct customer represented more than 10 % of the Company’s total revenue. For the three and nine months ended September 30, 2019, no agency, distributor, or direct customer represented more than 10 %of the Company’s total revenue. Financial Instruments The carrying values of cash and cash equivalents, short-term investments, accounts payable, notes payable, and other debt obligations approximate their fair values due to their short-term nature. Net Loss Per Common Share Basic earnings per share is computed by dividing loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of common stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 8). 10 Table of Contents Stock-Based Compensation The Company accounts for its stock-based compensation under the recognition requirements of accounting standards for accounting for stock-based compensation, for employees and directors whereby each option granted is valued at fair market value on the date of grant. Under these accounting standards, the fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model. The Company also follows the guidance of accounting standards for accounting for equity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. Shipping and Handling Costs The cost of shipping product to customers and distributors is typically borne by the customer or distributor. The Company records other shipping and handling costs in cost of revenue. Total freight costs amounted to approximately $ 188,000 and $ 133,000 , respectively, for the three months ended September 30, 2020 and 2019, and $ 471,000 and $ 491,000 , respectively, for the nine months ended September 30, 2020 and 2019. ​ 3. STOCKHOLDERS’ EQUITY Preferred Stock In June 2019, the Company amended and restated its certificate of incorporation. The amended and restated certificate of incorporation authorizes the issuance of up to 5,000,000 shares of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board of Directors. Common Stock In June 2019, the Company amended and restated its certificate of incorporation. The amended and restated certificate of incorporation increased the number of shares of common stock authorized for issuance from 50,000,000 shares to 100,000,000 shares. July 24, 2020 Offering On July 24, 2020, the Company closed an underwritten public offering of 6,052,631 shares of its common stock at a public offering price of $ 9.50 per share (the "Offering"). The Company completed the Offering pursuant to the terms of an Underwriting Agreement, dated as of July 21, 2020, by and among the Company and Cowen and Company, LLC and SVB Leerink LLC, as representatives of the several underwriters named therein. The Company received gross proceeds of approximately $ 57.5 million from the Offering. After deducting the underwriting discounts and commissions and fees and expenses payable by the Company in connection with the Offering, the Company received net proceeds of approximately $ 53.8 million. Shelf Registration On July 26, 2018, the Company filed a registration statement on Form S-3 with the SEC (as amended, the “2018 Shelf”). The 2018 Shelf, which was declared effective on August 7, 2018, enables the Company to offer and sell, in one or more offerings, any combination of common stock, preferred stock, senior or subordinated debt securities, warrants and units, up to a total dollar amount of $ 150 million. Termination of Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. On May 31, 2019, the Company delivered to Cantor Fitzgerald & Co. (“Cantor”) written notice of termination (the “Termination Notice”) of the Controlled Equity Offering Sales Agreement, dated November 4, 2015, by and between the Company and Cantor, as amended by Amendment No. 1 to Sales Agreement, dated July 26, 2018 (collectively, the “Sales Agreement”). In accordance with Section 13(b) thereof, the Sales Agreement terminated on June 10, 2019, ten (10) days after the delivery of the Termination Notice. As provided in the Sales Agreement, the Sales Agreement terminated without liability of any party to any other party, except that certain provisions of the Sales Agreement identified therein shall remain in full force and effect notwithstanding the termination. 11 Table of Contents Pursuant to the Sales Agreement, the Company offered and sold, from time to time through Cantor, shares of the Company’s common stock. In the aggregate, the Company sold 2,094,140 shares pursuant to the Sales Agreement, at an average selling price of $ 8.72 per share, generating net proceeds of approximately $ 17,718,000 from November 4, 2015 through December 31, 2018. There were no sales during the year ended December 31, 2019. Open Market Sale Agreement with Jefferies LLC and B. Riley FBR, Inc. On July 9, 2019, the Company entered into an Open Market Sale Agreement (the “New Sale Agreement”) with Jefferies LLC and B. Riley FBR, Inc. (each an “Agent” and, together, the “Agents”), pursuant to which the Company may sell, from time to time, at its option, shares of the Company’s common stock having an aggregate offering price of up to $ 25,000,000 through the Agents, as the Company’s sales agents. All shares of the Company’s common stock offered and sold,or to be offered and sold under the New Sale Agreement were or will be issued and sold pursuant to the Company’s 2018 Shelf by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, in block transactions or if specified by the Company, in privately negotiated transactions. On April 20, 2020, the Company and the Agents entered into an amendment to the New Sale Agreement (the "Amendment") to provide for an increase in the aggregate offering amount under the New Sales Agreement, such that as of April 20, 2020, the Company may offer and sell Shares having an additional aggregate offering price of up to $ 50 million under the New Sale Agreement, as amended by the Amendment (the "Amended Sale Agreement"). Subject to the terms of the Amended Sales Agreement, the Agents are required to use their commercially reasonable efforts consistent with their normal sales and trading practices to sell the shares of the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company is required to pay the Agents a commission of up to 3.0 % of the gross proceeds from the sale of the shares of the Company’s common stock sold thereunder, if any. The Company has also agreed to provide the Agents with customary indemnification rights. The offering of the shares of the Company’s common stock under the Amended Sales Agreement will terminate upon the earliest of (a) the sale of the maximum number or amount of the shares of the Company’s stock permitted to be sold under the Amended Sale Agreement and (b) the termination of the Amended Sale Agreement by the parties thereto. During the year ended December 31, 2019, the Company sold 191,244 shares pursuant to the Amended Sale Agreement, at an average selling price of $ 4.11 per share, generating net proceeds of approximately $ 762,000 . During the nine months ended September 30, 2020, the Company sold 4,110,625 shares pursuant to the Amended Sale Agreement, at an average selling price of $ 6.64 per share, generating net proceeds of approximately $ 26,476,000 . In the aggregate, the Company has sold 4,301,869 shares pursuant to the Amended Sale Agreement, at an average selling price of $ 6.53 per share, generating net proceeds of approximately $ 27,238,000 . In addition, during the nine months ended September 30, 2020, the Company paid approximately $ 49,000 in expenses related to the Amended Sale Agreement. Stock-Based Compensation Total share-based employee, director, and consultant compensation amounted to approximately $ 1,088,000 and $ 802,000 for the three months ended September 30, 2020 and 2019, and approximately $ 2,864,000 and $ 1,175,000 for the nine months ended September 30, 2020 and 2019, respectively. These amounts are included in the consolidated statements of operations and comprehensive loss under selling, general and administrative expenses. 12 Table of Contents The summary of the stock option activity for the nine months ended September 30, 2020 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Weighted ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ ​ ​ Exercise Price ​ Contractual ​ Shares per Share Life (Years) Outstanding, December 31, 2019 4,218,189 ​ $ 6.16 ​ 7.0 Granted ​ 1,593,825 ​ $ 6.18 ​ 9.3 Forfeited ​ ( 31,644 ) ​ $ 7.33 ​ — Expired ​ ( 224,047 ) ​ $ 5.60 ​ — Exercised ​ ( 321,375 ) ​ $ 4.35 ​ — Outstanding, September 30, 2020 ​ 5,234,948 ​ $ 6.36 ​ 7.4 ​ The fair value of each stock option was estimated using the Black Scholes pricing model which takes into account as of the grant date the exercise price (ranging from $ 5.68 to $ 10.58 per share) and expected life of the stock option ( 10 years ), the current price of the underlying stock and its expected volatility (ranging from 64.8 percent to 69.8 percent), expected dividends (- 0 - percent) on the stock and the risk free interest rate (ranging from 0.28 to 0.36 percent) for the term of the stock option. The intrinsic value is calculated at the difference between the market value as of September 30, 2020 of $ 7.975 and the exercise price of the shares. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Options Outstanding ​ ​ Number ​ Weighted ​ Weighted ​ ​ ​ Range of ​ Outstanding at ​ Average ​ Average ​ Aggregate Exercise ​ September 30, ​ Exercise ​ Remaining ​ Intrinsic Price 2020 Price Life (Years) Value $ 2.65 - $ 14.50 5,234,948 ​ $ 6.36 7.4 ​ $ 9,210,292 ​ ​ ​ ​ ​ ​ ​ ​ Options Exercisable Number ​ Weighted ​ ​ Exercisable at ​ Average ​ Aggregate September 30, ​ Exercise ​ Intrinsic 2020 Price Value 3,180,106 ​ $ 6.15 ​ $ 6,104,740 ​ The summary of the status of the Company’s non-vested options for the nine months ended September 30, 2020 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ Shares Fair Value ​ ​ ​ ​ ​ ​ Non-vested, December 31, 2019 1,183,790 ​ $ 4.49 Granted 1,593,825 ​ $ 3.74 Forfeited ( 31,641 ) ​ $ 3.75 Vested ( 691,135 ) ​ $ 4.26 Non-vested, September 30, 2020 2,054,842 ​ $ 4.00 ​ As of September 30, 2020, the Company had approximately $ 3,233,000 of total unrecognized compensation cost related to stock options which will be expensed over 30 months . On February 28, 2020, the Board of Directors granted options to purchase 1,041,325 shares of common stock to the Company’s employees which will vest upon the achievement of certain specific, predetermined milestones related to the Company’s 2020 operations. Once awarded, these options will vest in four equal traunches, the first traunch vesting on the date of the award. The grant date fair value of these unvested options amounted to approximately $ 6,279,000 . Based upon an assessment by management, which was reviewed with the Board of Directors, as of September 30, 2020, the Company met approximately 62.5 % of these milestones, and 13 Table of Contents accordingly we have recorded $ 419,000 and $ 616,000 in stock option expense related to these options in the three and nine months ended September 30, 2020, respectively. Change in Control-Based Awards of Restricted Stock Units: The Board of Directors has granted restricted stock units to members of the Board of Directors, to the Company’s executive officers, and to certain employees of the Company. These specific restricted stock units will only vest upon a Change in Control of the Company, as defined in the Company's Amended and Restated 2014 Long-Term Incentive Plan. The following table is a summary of these restricted stock units: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Restricted Stock Units ​ ​ ​ ​ ​ ​ Board of Executive Other ​ ​ ​ ​ Directors ​ Management ​ Employees ​ Total ​ Intrinsic Value December 31, 2019 ​ 277,200 ​ 604,500 ​ 1,205,050 ​ 2,086,750 ​ $ 8,033,988 Granted — 120,000 158,700 278,700 ​ Forfeited — — ( 25,250 ) ( 25,250 ) ​ September 30, 2020 277,200 724,500 1,338,500 2,340,200 ​ $ 18,663,095 ​ Due to the uncertainty over whether these restricted stock units will vest, which will only happen upon a Change in Control, no charge for these restricted stock units has been recorded in the consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 and 2019. Performance-Based Awards of Restricted Stock Units: Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2017, on February 28, 2018, the Board of Directors granted 146,200 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2016. These awards were valued at approximately $ 1,148,000 at the date of issuance, based upon the market price of the Company’s common stock at the date of the grant, and vest one third on the date of the grant one third on the first anniversary of the date of the grant, and one third on the second anniversary of the date of the grant. For the three and nine months ended September 30, 2020 and 2019, the Company recorded a charge (credit) of approximately $ 0 and $ 96,000 , and $( 23,000 ) and $ 298,000 , related to these restricted stock unit awards , respectively. Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2018, on March 4, 2019 the Board of Directors granted 22,220 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2017. These awards were valued at approximately $ 179,000 at the date of issuance, based upon the market price of the Company’s common stock at the date of the grant, and vest one third on the date of the grant, one third on the first anniversary of the date of the grant, and one third on the second anniversary of the date of the grant. For the three and nine months ended September 30, 2020 and 2019, the Company recorded a charge of approximately $ 12,000 and $ 15,000 , and $ 22,000 and $ 34,000 , related to these restricted stock unit awards , respectively. Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2019, on July 22, 2019 the Board of Directors granted 180,300 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2018. These awards were valued at approximately $ 1,300,000 at the date of issuance, based upon the market price of the Company’s common stock at the date of the grant, and vest one third on the date of the grant, one third on the first anniversary of the date of the grant, and one third on the second anniversary of the date of the grant. For the three and nine months ended September 30, 2020 and 2019, the Company recorded a charge of approximately $ 256,000 and $ 103,000 and $ 461,000 and $ 525,000 , related to these restricted stock unit awards , respectively. Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2019, on February 28, 2020, the Board of Directors granted 168,100 restricted stock units to certain senior managers of the Company in order to settle bonuses accrued as of December 31, 2019. These awards were valued at approximately $ 1,014,000 at the date of issuance, based upon the market price of the Company’s common stock at the date of the grant, and vest one third on the date of the grant one third on the first anniversary of the date of the grant, and one third on the second anniversary of the date of the grant. For the three and nine 14 Table of Contents months ended September 30, 2020 and 2019, the Company recorded a charge of approximately $ 84,000 and $ 0 and $ 535,000 and $ 0 , related to these restricted stock unit awards , respectively. The following table is a summary of the activity related to these restricted stock units during the nine months ended September 30, 2020: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ Shares Fair Value Non-vested, January 1, 2020 167,872 ​ $ 7.52 Granted 168,100 ​ $ 6.03 Vested ( 162,000 ) ​ $ 7.05 Non-vested, September 30, 2020 173,972 ​ $ 6.52 ​ Warrants: As of September 30, 2020, the Company had no warrants outstanding. ​ 4. REVENUE The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2020: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ United States ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ Government ​ ​ ​ ​ Direct Strategic Partners Agencies Total Product sales: ​ ​ ​ ​ United States ​ $ 222,300 ​ $ 39,200 ​ $ — ​ $ 261,500 Germany ​ 4,818,029 ​ — ​ — ​ 4,818,029 All other countries ​ 1,293,829 ​ 3,872,284 ​ — ​ 5,166,113 Total product revenue ​ 6,334,158 ​ 3,911,484 ​ — ​ 10,245,642 Grant and other income: ​ ​ ​ ​ ​ ​ ​ ​ United States ​ — ​ — ​ 300,970 ​ 300,970 ​ ​ ​ ​ ​ ​ ​ ​ ​ Total revenue ​ $ 6,334,158 ​ $ 3,911,484 ​ $ 300,970 ​ $ 10,546,612 ​ The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2019: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ United States ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ Government ​ ​ ​ ​ Direct Strategic Partners Agencies Total Product sales: ​ ​ ​ ​ United States ​ $ 80,000 ​ $ — ​ $ — ​ $ 80,000 Germany ​ 3,445,632 ​ — ​ — ​ 3,445,632 All other countries ​ 745,888 ​ 1,456,943 ​ — ​ 2,202,831 Total product revenue ​ 4,271,520 ​ 1,456,943 ​ — ​ 5,728,463 Grant and other income: ​ ​ ​ ​ United States ​ — ​ — ​ 366,544 ​ 366,544 ​ ​ ​ ​ ​ ​ ​ Total revenue ​ $ 4,271,520 ​ $ 1,456,943 ​ $ 366,544 ​ $ 6,095,007 ​ 15 Table of Contents The following table disaggregates the Company's revenue by customer type and geographic area for the nine months ended September 30, 2020: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ United States ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ Government ​ ​ ​ ​ Direct Strategic Partners Agencies Total Product sales: ​ ​ ​ ​ United States ​ $ 957,800 ​ $ 39,200 ​ $ — ​ $ 997,000 Germany ​ 14,271,239 ​ — ​ — ​ 14,271,239 All other countries ​ 3,767,521 ​ 8,886,180 ​ — ​ 12,653,701 Total product revenue ​ 18,996,560 ​ 8,925,380 ​ — ​ 27,921,940 Grant and other income: ​ ​ ​ ​ ​ ​ ​ ​ United States ​ — ​ — ​ 1,126,885 ​ 1,126,885 Total revenue ​ $ 18,996,560 ​ $ 8,925,380 ​ $ 1,126,885 ​ $ 29,048,825 ​ The following table disaggregates the Company's revenue by customer type and geographic area for the nine months ended September 30, 2019: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ United States ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ Government ​ ​ ​ ​ Direct Strategic Partners Agencies Total Product sales: ​ ​ ​ ​ United States ​ $ 146,800 ​ $ — ​ $ — ​ $ 146,800 Germany ​ 10,242,943 ​ — ​ — ​ 10,242,943 All other countries ​ 2,403,139 ​ 3,362,577 ​ — ​ 5,765,716 Total product revenue ​ 12,792,882 ​ 3,362,577 ​ — ​ 16,155,459 Grant and other income: ​ ​ ​ ​ ​ ​ ​ ​ United States ​ — ​ — ​ 1,363,703 ​ 1,363,703 Total revenue ​ $ 12,792,882 ​ $ 3,362,577 ​ $ 1,363,703 ​ $ 17,519,162 ​ The Company has two primary revenue streams: (1) sales of the CytoSorb device and related device accessories and (2) grant income from contracts with various agencies of the United States government. The following is a brief description of each revenue stream. CytoSorb Sales The Company sells its CytoSorb device using both its own sales force (direct sales) and through the use of distributors and/or strategic partners. All sales of the device are outside the United States, as CytoSorb is not yet approved in the United States, other than in respect of the EUA. Direct sales are fulfilled from the Company’s office in Berlin, Germany. Direct sales relate to sales to hospitals located in Germany, Switzerland, Austria, Belgium, Luxembourg, Poland, the Netherlands, Sweden, Denmark and Norway. There are no formal sales contracts with any direct customers relating to product price or minimum purchase requirements. However, there are agreements in place with certain direct customers that provide for either free of charge product or rebate credits based upon achieving minimum purchase levels. The Company records the value of these items earned as a reduction of revenue. These customers submit purchase orders and the order is fulfilled and shipped directly to the customer. Prices to all direct customers are based on a standard price list based on the packaged quantity (6 packs vs 12 packs). Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. The Company has a formal written contract with each distributor/strategic partner. These contracts have terms ranging from 1 - 5 years in length, with three years being the typical term. In addition, certain distributors are eligible for volume discount pricing if their unit sales are in excess of the base requirement per the contract. Each distributor's/strategic partner's contract has minimum annual purchase requirements in order to maintain exclusivity in their respective territories. 16 Table of Contents There is no additional consideration or monetary penalty that would be required to be paid to the Company if a distributor does not meet the minimum purchase commitments included in the contract, however, at the discretion of the Company, the distributor may lose its exclusive rights in the territory if such commitments are not met. Government Grants The Company has been the recipient of various grant contracts from various agencies of the United States government, primarily the Department of Defense, to perform various research and development activities. These contracts fall into one of the following categories: 1. Fixed price – the Company invoices the contract amount in equal installments over the term of the contract without regard to the timing of the costs incurred related to this contract. 2. Cost reimbursement – the Company submits monthly invoices during the term of the contract for the amount of direct costs incurred during that month plus an agreed percentage that relates to allowable overhead and general and administrative expenses. Cumulative amounts invoiced may not exceed the maximum amount of funding stipulated in the contract. 3. Cost plus – this type of contract is similar to a cost reimbursement contract but this type also allows for the Company to additionally invoice for a fee amount that is included in the contract. 4. Performance based – the Company submits invoices only upon the achievement of the milestones listed in the contract. The amount to be invoiced for each milestone is documented in the contract. In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels, and contracts with various government agencies related to the Company’s grants. The Company does not currently incur any outside/third party incremental costs to obtain any of these contracts. The Company does incur internal costs, primarily salary related costs, to obtain the contracts related to the grants. Company employees spend time reviewing the program requirements and developing the budget and related proposal to submit to the grantor agency. There may additionally be travel expenditures involved with meeting with government agency officials during the negotiation of the contract. These internal costs are expensed as incurred. ​ The following table provides information about receivables and contract liabilities from contracts with customers: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2020 December 31, 2019 Receivables, which are included in grants and accounts receivable ​ $ 3,175,385 ​ $ 2,246,821 Contract liabilities ​ $ 163,241 ​ $ 171,842 ​ Contract liabilities represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements during the periods ended September 30, 2020 and December 31, 2019, and deferred revenue on distributor/strategic partner contracts. Deferred revenue is the difference between the average selling price anticipated for the year ended 2020 and the actual price invoiced during the nine months ended September 30, 2020. There was no deferred revenue liability as of December 31, 2019. ​ 17 Table of Contents 5. LONG-TERM DEBT, NET On June 30, 2016, the Company and its wholly-owned subsidiary, CytoSorbents Medical, Inc. (together, the “Borrower”), entered into a Loan and Security Agreement with Bridge Bank, a division of Western Alliance Bank, (the “Bank”), pursuant to which the Company borrowed $ 10 million in two equal tranches of $ 5 million (the “Original Term Loans”). On March 29, 2018 (the “Closing Date”), the Original Term Loans were refinanced with the Bank pursuant to an Amended and Restated Loan and Security Agreement by and between the Bank and the Borrower (the “Amended and Restated Loan and Security Agreement”), under which the Bank agreed to loan the Borrower up to an aggregate of $ 15 million to be disbursed in two tranches (1) one tranche of $ 10 million (the “Term A Loan”), which was funded on the Closing Date and used to refinance the Original Term Loans, and (2) a second tranche of $ 5 million which could have been disbursed at the Borrower’s sole request prior to March 31, 2019 provided certain conditions were met (the “Term B Loan” and together with the Term A Loan, the “Term Loans”). On July 31, 2019 (the “Settlement Date”), the Borrower entered into the First Amendment to the Amended and Restated Loan and Security Agreement (the “First Amendment”) with the Bank, which amended certain provisions of the Amended and Restated Loan and Security Agreement and the 2018 Success Fee Letter (the “2018 Letter”). In connection with the execution of the First Amendment, the draw period for the Term B Loan was extended to August 15, 2019 and the Company drew down the full $ 5.0 million Term B Loan on the Settlement Date, bringing the total outstanding debt to $ 15,000,000 at July 31, 2019. The proceeds of Term Loans were used for general business requirements in accordance with the Amended and Restated Loan and Security Agreement. The outstanding balances on Term Loans bear interest at the prime rate reported in the Wall Street Journal plus 3.66 %. This rate was 6.91 % at September 30, 2020. On the Closing Date, the Company was required to pay a non-refundable closing fee of $ 25,000 , expenses incurred by the Bank related to the Amended and Restated Loan and Security Agreement of $ 11,000 and a portion of the final fee for the period the Original Term Loans was outstanding of $ 85,938 . In addition, the Company incurred legal expenses related to the Amended and Restated Loan and Security Agreement of $ 20,050 . As of the Closing Date, the total unamortized loan costs related to the Term Loans amounted to $ 130,060 . These costs have been presented as a direct deduction from the proceeds of the loan on the consolidated balance sheet in accordance with the provisions of ASC 850. These costs are being amortized over the loan period as a charge to interest expense. For the three and nine months ended September 30, 2020, the Company recorded interest expense amounting to $ 8,524 and $ 25,573 , and for both the three and nine months ended September 30, 2019 the Company recorded interest expense amounting to $ 8,393 and $ 24,651 , respectively, related to these costs. Under the terms of the First Amendment, commencing on the first calendar day of the calendar month after the Term B Loan was made, the Company is required to make monthly payments of interest-only through April 2020. The interest-only period will be further extended through November 2020 provided the Borrower has been compliant with its obligations under the financial covenant revenue test set forth in the Amended and Restated Loan and Security Agreement for all months from the month immediately after the month in which the Term B Loan is funded through March 2020. Since the Company has complied with its obligations under the financial covenant revenue test through March 2020, commencing on November 1, 2020, the Company will make equal monthly payments of principal of $ 833,333 , together with accrued and unpaid interest. All unpaid principal and accrued and unpaid interest will be due and payable in full on April 1, 2022. In addition, the Amended and Restated Loan and Security Agreement requires the Company to pay a non-refundable final fee equal to 2.5 % of the principal amount of each Term Loan funded upon the earlier of the (i) April 1, 2022 maturity date or (ii) termination of the Term Loan via acceleration or prepayment. This final fee is being accrued and charged to interest expense over the term of the Term Loans. For the three and nine months ended September 30, 2020 and 2019, the Company recorded interest expense of $ 27,344 and $ 23,437 , respectively, and $ 82,031 and $ 54,687 , respectively, related to the final fee. The Term Loans are evidenced by secured promissory notes issued to the Bank by the Company. If the Company elects to prepay the Term Loans pursuant to the terms of the Amended and Restated Loan and Security Agreement, it will owe a prepayment fee to the Bank, as follows: (1) for a prepayment made on or after the funding date of a Term Loan through and including the first anniversary of such funding date, an amount equal to 2.0 % of the principal amount of such Term Loan prepaid; (2) for a prepayment made after the first anniversary of the funding date of a Term Loan through and including the second anniversary of such funding date, an amount equal to 1.5 % of the principal amount of such Term Loan prepaid; and (3) for a prepayment made after the second anniversary of the funding date of a Term Loan through April 1, 2022, an amount equal to 1.0 % of the principal amount of such Term Loan prepaid. Events of default which may cause repayment of the Term Loans to be accelerated include, among other customary events of default, (1) non-payment of any obligation when due, (2) the failure to perform any obligation required under the Amended and Restated Loan and Security Agreement and to cure such default within a reasonable time frame, (3) the occurrence of a Material Adverse Event (as defined in the Amended and Restated Loan and Security Agreement), (4) the attachment or seizure of a material portion of the Borrower’s assets if such attachment or seizure is not released, discharged or rescinded within 10 days, and (5) if the Borrower becomes insolvent or starts an insolvency proceeding or if an insolvency proceeding is brought by a third party against the Borrower and such proceeding is not dismissed or stayed within 30 days. The Amended and Restated Loan and Security Agreement includes customary 18 Table of Contents loan conditions, Borrower representations and warranties, Borrower affirmative covenants and Borrower negative covenants for secured transactions of this type. The Company is in compliance with these covenants. The Company’s and CytoSorbents Medical, Inc.’s obligations under the Amended and Restated Loan and Security Agreement are joint and severable and are secured by a first priority security interest in favor of the Bank with respect to the Company’s Shares (as defined in the Amended and Restated Loan and Security Agreement) and the Borrower’s Collateral (as defined in the Amended and Restated Loan and Security Agreement, which definition excludes the Borrower’s intellectual property and other customary exceptions). 2018 Success Fee Letter: Pursuant to the amended 2018 Letter, the Borrower shall pay to the Bank a success fee in the amount equal to 6.37 % of the funded amount of the Term B Loan (as defined in the Restated Loan and Security Agreement) (the “Success Fee”) upon the first occurrence of any of the following events: (a) a sale or other disposition by the Borrower of all or substantially all of its assets; (b) a merger or consolidation of the Borrower into or with another person or entity, where the holders of the Borrower’s outstanding voting equity securities as of immediately prior to such merger or consolidation hold less than a majority of the issued and outstanding voting equity securities of the successor or surviving person or entity as of immediately following the consummation of such merger or consolidation; (c) a transaction or a series of related transactions in which any “person” or “group” (within the meaning of Section 13(d) and 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of a sufficient number of shares of all classes of stock then outstanding of the Borrower ordinarily entitled to vote in the election of directors, empowering such “person” or “group” to elect a majority of the Board of Directors of the Borrower, who did not have such power before such transaction; or (d) the closing price per share for the Company’s common stock on the Nasdaq Capital Market being the greater of (i) 70 % or more over $ 7.05 , the closing price of the Company’s common stock on March 29, 2018 (after giving effect to any stock splits or consolidations effected after the date thereof) for five successive business days, or (ii) at least 26.13 % more than the average price of Company’s common stock for the 365 day period ending on the date of the funding of the Term B Loan. Long-term debt consists of the following at September 30, 2020: ​ ​ ​ ​ ​ Principal amount ​ $ 15,000,000 Less unamortized debt acquisition costs ​ ( 51,145 ) Plus accrued final fee ​ 210,937 Subtotal ​ 15,159,792 Less Current maturities ​ ( 9,166,667 ) Long-term debt net of current maturities ​ $ 5,993,125 ​ Principal payments of long-term debt are due as follows during the twelve months ending September 30 th : ​ ​ ​ ​ ​ 2021 $ 9,166,667 2022 ​ 5,833,333 Total ​ $ 15,000,000 ​ Payroll Protection Program: On April 13, 2020, the Company received approximately $ 1,411,000 in loan proceeds from the Payroll Protection Program (the "PPP") administered by the Small Business Administration (the "SBA") of the United States government. This program was established under the Coronavirus Aid, Relief and Economic Security Act (the "CARES Act"). On April 29, 2020, following a reassessment of the Company's financial and operating position, including cash on hand and access to public capital markets, the Company repaid the PPP loan. ​ 19 Table of Contents 6. COMMITMENTS AND CONTINGENCIES Employment Agreements On July 30, 2019, CytoSorbents Corporation entered into amended and restated executive employment agreements with its principal executives, Dr. Phillip P. Chan, Chief Executive Officer, Vincent Capponi, President and Chief Operating Officer, and Kathleen P. Bloch, Chief Financial Officer. Each of the agreements has an initial term of three years , and was retroactively effective as of January 1, 2019. On April 12, 2020, CytoSorbents Corporation entered into an executive employment agreement with Dr. Efthymios Deliargyris, who began employment as Chief Medical Officer on May 1, 2020, with an initial term that expires on December 31, 2021. After the expiration of the initial terms, the employment agreements will automatically renew for additional terms of one year unless either party provides written notice of non-renewal at least 60 days prior to a renewal. The foregoing employment agreements each provide for base salary and other customary benefits which include participation in group insurance plans, paid time off and reimbursement of certain business related expenses, including travel and continuing educational expenses, as well as bonus and/or equity awards at the discretion of the Board of Directors. In addition, the agreements provide for certain termination benefits in the event of termination without “Cause” or voluntary termination of employment for “Good Reason”, as defined in each agreement. The agreements also provide for certain benefits in the event of a “Change of Control” of the Company, as defined in each agreement. Litigation The Company is from time to time subject to claims and litigation arising out of the ordinary course of business. The Company intends to defend vigorously against any future claims and litigation. The Company is not currently a party to any significant legal proceedings. Royalty Agreements In 2003, the Company granted a perpetual royalty (the “Royalty”) equal to three percent of all gross revenues received by the Company from sales of CytoSorb in the applications of sepsis, cardiopulmonary bypass surgery, organ donor, chemotherapy and inflammation control. For the three months ended September 30, 2020 and 2019, the Company has recorded royalty costs of approximately $ 306,000 and $ 169,000 , respectively. For the nine months ended September 30, 2020 and 2019, the Company has recorded royalty costs of approximately $ 829,000 and $ 478,000 , respectively. License Agreements In March 2006, the Company entered into a license agreement which provides the Company the exclusive right to use its patented technology and proprietary know how relating to adsorbent polymers for a period of 18 years. Under the terms of the agreement, the Company has agreed to pay royalties of 2.5 % to 5 % on the sale of certain of its products if and when those products are sold commercially for a term not greater than 18 years commencing with the first sale of such product. For the three months ended September 30, 2020 and 2019, per the terms of the license agreement, the Company has recorded royalty costs of approximately $ 510,000 and $ 282,000 , respectively. For the nine months ended September 30, 2020 and 2019, the Company recorded royalty costs of approximately $ 1,381,000 and $ 797,000 , respectively. ​ 7. LEASES Effective January 1, 2019, the Company adopted the provisions of Accounting Standards Update ("ASU") 2016-02, Leases (Topic 842). The provisions of this ASU require the Company to record a right-of-use asset and related lease liability related to their leases. The Company leases its operating facilities in both the United States and Germany under operating lease agreements. In the United States, in May 2020, the Company entered into a Nineteenth Amendment to Lease with the landlord which became effective May 1, 2020. This amendment expands the Company’s space to 20,821 square feet and extends the term of the lease to May 31, 2021. The Company’s base rent is approximately $ 34,000 per month. In addition, the Company is obligated to pay monthly operating expenses of approximately $ 30,000 per month. The amendment also includes a one year renewal option. The base rent for the renewal term will increase by the greater of five percent or the increase in the Consumer Price Index. There were no lease incentives and no initial direct costs were incurred related to this lease amendment. 20 Table of Contents In Germany, the Company leases its operating facility under two operating lease agreements. These leases require combined base rent payments amounting to approximately $ 8,800 per month. The initial lease term of both leases ends August 31, 2021. In addition, the Company is obligated to monthly operating expenses of approximately $ 2,900 per month. Both leases have a five year option to renew that would extend the lease term to August 31, 2026. There are no provisions in the leases to increase the base rent during the renewal period. There were no lease incentives and no initial direct costs were incurred related to these leases. Initial Measurement of Right-Of-Use Asset and Lease Liability: The Company's consolidated balance sheets reflect the value of the right-of-use asset and related lease liability. This value was calculated based on the present value of the remaining base rent lease payments. The remaining lease payments include the renewal periods for both facilities as the Company has determined that it is probable that the renewal options will be exercised under each of the lease agreements. The discount rate used was the Company’s incremental borrowing rate, which is 9.16 %, as the Company could not determine the rate implicit in the lease. As a result, the value of the right-of- use asset and related lease liability is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ December 31, ​ 2020 2019 Right-of-use asset $ 1,131,915 $ 1,070,762 ​ ​ ​ ​ ​ ​ ​ Total lease liability ​ $ 1,131,915 ​ $ 1,070,762 Less current portion ​ ( 432,423 ) ​ ( 428,083 ) Lease liability, net of current portion ​ $ 699,492 ​ $ 642,679 ​ The maturities of the lease liabilities due in the twelve months ending September 30, 2020: ​ ​ ​ ​ ​ 2021 $ 432,423 2022 ​ 345,067 2023 ​ 78,823 2024 ​ 86,354 2025 ​ 94,605 Thereafter ​ 94,643 Total ​ $ 1,131,915 ​ For the three months ended September 30, 2020 and 2019, operating cash flows paid in connection with operating leases amounted to approximately $ 211,000 and $ 234,000 , and $ 658,000 and $ 674,000 for the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020 and December 31, 2019, the weighted average remaining lease term was 4.3 years and 4.10 years, respectively. 8. NET LOSS PER SHARE Basic loss per share and diluted loss per share for the three months ended September 30, 2020 and 2019 have been computed by dividing the net loss for each respective period by the weighted average number of shares outstanding during that period. All outstanding warrants and options and restricted stock awards representing approximately 7,749,000 and 7,329,000 incremental shares at September 30, 2020 and 2019, respectively, have been excluded from the computation of diluted loss per share as they are anti-dilutive. ​ 9. SUBSEQUENT EVENTS On October 9, 2020, the Company announced that the U.S. Army Medical Research Acquisition Activity (USAMRAA), has awarded the Company a two-year SBIR Sequential Phase II contract valued at $ 1,098,588 to optimize development of the HemoDefend-BGA™ adsorber. The HemoDefend-BGA adsorber can rapidly remove greater than 99 % of anti-A and anti-B antibodies from plasma to create a “universal plasma” that could be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity. ​ 21 Table of Contents